-----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, Lv4C71IQKtTduADHELipyIiiiZiNzf8zMdvDLc4urg8LxhJuRU+87I7eBWIBdRRq 53ucm4idoFWWVXe2eDXPmQ== 0000912057-00-014568.txt : 20000331 0000912057-00-014568.hdr.sgml : 20000331 ACCESSION NUMBER: 0000912057-00-014568 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 19991231 FILED AS OF DATE: 20000330 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMMUNE RESPONSE CORP CENTRAL INDEX KEY: 0000817785 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 330255679 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: SEC FILE NUMBER: 000-18006 FILM NUMBER: 584290 BUSINESS ADDRESS: STREET 1: 5935 DARWIN COURT CITY: CARLSBAD STATE: CA ZIP: 92008 BUSINESS PHONE: 6194317080 MAIL ADDRESS: STREET 1: 5935 DARWIN COURT CITY: CARLSBAD STATE: CA ZIP: 92008 10-K 1 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K /X/ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange - --- Act of 1934. For the fiscal year ended DECEMBER 31, 1999 or / / Transition report pursuant to Section 13 or 15(d) of the Securities - --- Exchange Act of 1934. For the transition period from __________ to __________. Commission file number: 0-18006 THE IMMUNE RESPONSE CORPORATION (Exact name of registrant as specified in its charter) DELAWARE 33-0255679 (State or other jurisdiction of (IRS Employer Identification No.) incorporation or organization) 5935 DARWIN COURT, CARLSBAD, CA 92008 Address of principal executive offices (760) 431-7080 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 $.0025 Preferred Stock Purchase Rights (Title of Class) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No --- --- Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [ ] The aggregate market value of the Common Stock held by non-affiliates of the registrant, based upon the last sale price of the Common Stock reported on the National Association of Securities Dealers Automated Quotation National Market System on March 10, 2000 was $341,346,000. The number of shares of Common Stock outstanding as of March 10, 2000 was 27,209,345. DOCUMENTS INCORPORATED BY REFERENCE (To the Extent Indicated Herein) Registrant's Proxy Statement to be filed with the Securities and Exchange Commission in connection with the solicitation of proxies for the Registrant's 2000 Annual Meeting of Stockholders to be held on May 25, 2000 is incorporated by reference in Part III, Items 10 (as to directors), 11, 12 and 13 of this Form 10-K. 2 ITEM 1. BUSINESS GENERAL The Immune Response Corporation ("Immune Response" or the "Company") is a biopharmaceutical company developing immune-based therapies to induce specific immune responses for the treatment of HIV, autoimmune diseases and cancer. In addition, the Company is developing a targeted non-viral delivery technology for gene therapy, which is designed to enable the delivery of genes directly to the liver via intravenous injection. The Company's gene therapy program is focused on diseases of the liver.
PRODUCTS UNDER DEVELOPMENT(1) PRECLINICAL PHASE 1 PHASE 2 PHASE 3 ----------- ------- ------- ------- IMMUNE-BASED THERAPIES HIV [GRAPH] ----------------------------------------------------------- Rheumatoid Arthritis [GRAPH] --------------------------------------------- Psoriasis [GRAPH] ------------------------------------- Multiple Sclerosis [GRAPH] ---------------------------- Colon Cancer [GRAPH] ---------------------------- Brain Cancer [GRAPH] --------------- Melanoma Cancer [GRAPH] Prostate Cancer [GRAPH] GENE THERAPY Hemophilia A [GRAPH] Hepatitis [GRAPH]
(1) The table describes the status of the current product candidates and is not intended to depict the relative lengths of time of any of the stages of drug discovery and preclinical and clinical development. The amount of time spent in any phase of development will vary substantially from product to product and there can be no assurance that any of the products will proceed beyond the phase depicted or will receive regulatory approval. See "Government Regulation." THE IMMUNE SYSTEM The immune system is the body's natural defense mechanism to prevent and combat disease. When a competent immune system recognizes a foreign material or biological invader it normally induces a response. There are two major arms of the immune system: T cell-based and B cell or antibody-based. T cells are specialized white blood cells that are normally produced by the body to kill infected cells. A T cell-based immune response begins when these specialized T cells, immune cells, recognize foreign "invaders" such as viruses or bacteria within the body. However, significant evidence suggests that infections trigger a T cell-based immune response during the initial course of their progression but this response is not always sufficient to eradicate the disease. In fact, some diseases are able to produce substances that suppress the immune response, thus making it important to provide assistance to the immune system. The Company believes that its technology will regulate the body's immune system to recognize and combat diseases such as HIV, autoimmune disease and cancer. Ways that this can be accomplished are by boosting the killer T cell responses against HIV and cancer and boosting the regulatory T cell response against the disease inducing T cells in autoimmune diseases such as rheumatoid arthritis, psoriasis and multiple sclerosis. OUR IMMUNE BASED THERAPIES IMMUNE BASED THERAPIES FOR HIV BACKGROUND. AIDS, which is caused by a virus known as HIV, is a condition that slowly destroys the body's immune system making the body vulnerable to opportunistic infections. The spread of HIV is a result of the virus invading the host cell where it uses the host cell's protein synthesis capability to replicate. The immune system responds by 3 producing antibody and cellular immune responses capable of attacking HIV. While these and other responses are usually sufficient to temporarily arrest progress of the infection and reduce levels of virus in the blood, the virus continues to replicate and slowly destroys the immune system by infecting and killing critical T cells, known as CD4 cells. The CD4 cells are needed to maintain the immune system. As the infection progresses, the immune system's control of HIV levels weakens, the level of virus in the blood rises and the level of critical T cells declines to a fraction of normal level. Currently available antiviral products have been shown to be effective at reducing the levels of virus in the blood, however, certain limitations in the therapy have prevented the antiviral products from being as effective as originally predicted. This is due primarily to viral resistance and the inability to stimulate the infected individual's own immune system to kill the virus. The World Health Organization ("WHO") estimates there are approximately 33 million individuals around the world infected with HIV. WHO also stated that during 1998, 5.8 million individuals (including 590,000 children) became infected with HIV. This represents approximately 16,000 new infections per day. In the United States, the number of HIV-infected individuals is estimated at 1 million. The HIV epidemic represents a significant societal threat to both developed and developing nations since most of the HIV-infected individuals are expected to ultimately develop AIDS, creating a significant burden on healthcare systems and economies around the world. REMUNE. REMUNE is designed to stimulate an HIV-infected individual's immune system to attack HIV. The Company believes results from its previous clinical trials demonstrated that REMUNE significantly boosts HIV-specific immune responses in HIV-infected individuals. Furthermore, the Company believes REMUNE stimulates the production of specific antiviral substances, such as chemokines, which naturally protect T cells from HIV infection. By utilizing an immune-based therapy such as REMUNE, the Company believes it may be possible to boost the HIV infected individual's immune system against the virus and further optimize the effects of antiviral drug therapy. HIV opinion leaders have begun to recognize that in order to effectively stop or slow the progression of HIV to AIDS, therapies must stimulate HIV cell mediated immune response in infected individuals (HIV-specific T cell proliferation) in addition to reducing viral load through the use of antiviral drugs. Furthermore, and most importantly, antiviral drugs do not enhance HIV specific immune function which is now thought by numerous researchers to be important in controlling HIV replication. The use of REMUNE to reconstitute HIV specific immunity may provide a unique niche for REMUNE to be utilized in combination with drug therapy to provide long-term management of HIV. CLINICAL TRIALS. In 1999, the Company discontinued a 2,526 patient Phase 3 clinical endpoint trial. The trial was discontinued because differences in clinical endpoints were not observed between treatment groups and extending the trial would have been unlikely to provide sufficient additional clinical endpoints to permit statistically significant differences between the treatment groups to be observed in the near term. The primary efficacy endpoint for the trial was disease progression to an AIDS defining condition, or death. At the time the study began this was the only accepted endpoint for approval by the FDA for vaccines. However, since the discontinuation of the 2,526 patient Phase 3 trial, the FDA has agreed to accept virologic endpoint trials for the basis of approval for REMUNE. This allows the Company to use virologic failure as the primary endpoint, which was accepted, for most of the antiretroviral products that have been approved under the drug division of the FDA. Under the revised requirements, Agouron Pharmaceuticals, Inc. ("Agouron"), a wholly owned subsidiary of Warner-Lambert Company, and Immune Response have initiated a Phase 3 pivotal trial in 550 patients to evaluate whether REMUNE plus highly active antiviral therapy (HAART) delays the time to virologic failure. This trial will assess whether REMUNE plus HAART is capable of delaying the time that the HIV virus increases in a patient's blood. If the trial is successfully enrolled and completed, results can be expected by the second half of 2001. The Thailand clinical trial in 297 infected Thai patients, conducted by Trinity Medical, was completed in 1999. The primary endpoint was increase in CD4 cells. The primary endpoint was met in this 40-week clinical trial. Although patients received no antiviral drug therapy, REMUNE augmented CD4 cells and enhanced HIV specific immunity. Further follow-up has shown stable or decreased viral load in a majority of the patients that have been examined. A REMUNE study is also being conducted in Spain. The ongoing 243 patient trial combines REMUNE with antiviral drug therapy and is assessing the effect of REMUNE on virologic failure. The data safety monitoring board for this trial, which was designed to evaluate immunologic and virologic endpoints, met in the fourth quarter of 1999 and concluded that the trial could continue to completion which is scheduled for April 2001. The results of a Phase 1, 10 patient pediatric trial conducted by the National Institutes of Health were published in the Journal of Infectious Disease showing that REMUNE was well tolerated in children on antiviral drug therapy 4 and induced HIV specific immune responses. Furthermore, the results showed that children receiving the adult dose of REMUNE had a significant sustained decrease in viral load compared to children who received a lower dose. Previous Phase 1 and 2 studies in approximately 350 subjects indicated that REMUNE was well tolerated with the most common side effect being injection site reactions. These trials indicated that REMUNE is safe, that it may induce HIV- specific immune responses and showed positive trends on the virologic and immunologic markers. TECHNOLOGY. Remune is composed of inactivated HIV, depleted of its envelope, and emulsified in Incomplete Freund's Adjuvant ("IFA"), an agent which elicits a more potent immune response by more effectively presenting the inactivated virus to the immune system. Remune is manufactured by first culturing HIV-infected human T cells. The virus is then purified from this cell culture and inactivated with betapropiolactone, a chemical agent commonly used for viral inactivation, and then physically inactivated with irradiation. Each of these procedures alone is capable of inactivating HIV. During processing and purification, the outer envelope protein of the virus, known as gp120, is depleted from the inactivated HIV. The final envelope-depleted HIV is emulsified in IFA and is filled in syringes. When introduced into HIV-infected individuals, Remune appears to stimulate an HIV-specific immune system response, which the Company believes may provide a safe, effective and long-lasting benefit to these individuals. REMUNE is based on the core proteins of the virus, which are consistent across multiple strains of HIV. Earlier approaches to HIV immune-based therapies were based on the viral envelope, proteins located on the outside of the virus, and may not have been effective due to mutations in the viral envelope. The Company believes REMUNE has shown to be well tolerated after repeated use in over 2,000 individuals. The Company believes REMUNE may be an appropriate treatment for HIV-infected individuals to take alone or in combination with other treatments. REMUNE is administered by intramuscular injection, by a healthcare professional, once every three months. Currently, the HIV-1 virus continues to evolve and mutate and as a result different strains or clades of HIV-1 have emerged worldwide. This creates a moving target for single protein immunogens that are being developed that are clade specific. The Company believes that, because REMUNE is a whole virus and contains the core proteins that are more genetically conserved, individuals treated with REMUNE may be able to elicit broad immune responses to multiple subtypes of HIV-1 found throughout the world. This type of broad cross reactivity may have future implications for both therapeutic and preventive vaccines. EXISTING THERAPIES FOR HIV. Currently available antiviral products have been shown to be effective at reducing the levels of virus in the blood, however, certain limitations in the therapy have prevented the antiviral products from being as effective as originally predicted. The antiviral products may be associated with significant toxicity and eventual induction of viral resistance. In addition, non-compliance with the strict dosage regimen may also reduce the effectiveness and can accelerate emergence of resistance. REMUNE BENEFITS. It is currently estimated that only 30% to 40% of HIV-infected individuals in the United States use cocktail therapies (various combinations of reverse transcriptase and protease inhibitors). Of these individuals, up to 50% discontinue treatment due to resistance, toxicity, lack of compliance or because the cocktail therapy was not effective in reducing the viral load. REMUNE, unlike drugs, can induce an HIV specific response, is well tolerated and is easy to administer. REMUNE has been administered to over 2,000 patients and has an excellent safety profile. Most importantly, antiviral drugs do not enhance HIV-specific immune function, which is now thought by numerous researchers to be important in controlling HIV replication. The fact that REMUNE reconstitutes HIV-specific immunity provides a unique niche for REMUNE to be utilized in combination with drug therapy to provide long-term management of disease. One goal of the combination REMUNE-drug approach is to prolong the impact of antiviral drug therapies on viral load by increasing the immune response to HIV-infected cells. If successful, a delay in drug resistance and a prolonged duration of low levels of virus in the blood coupled with an increase in the immune response to HIV could translate into clinical benefit. MANUFACTURING. The Company subleases a 52,500 square foot facility in King of Prussia, Pennsylvania dedicated to the manufacture of REMUNE for clinical trials and, if the FDA approves the product, initial commercial production. In February 1996, the Company received clearance from the FDA to release the product for use in clinical trials. The Company believes the facility, which is a full-scale, GMP commercial process facility, is capable of supplying 5 clinical trial quantities and initial commercial quantities. The Company relies on a third party for the final inactivation step of the manufacturing process. If the existing manufacturing operations prove inadequate, there can be no assurance that any arrangement with a third party can be established on a timely basis, or that the Company can establish other manufacturing capacity on a timely basis. The Company believes that the raw materials necessary to produce REMUNE are readily available from various sources. COMMERCIALIZATION STRATEGY. During June 1998, the Company and Agouron entered into an agreement under which the Company exclusively licensed to Agouron the marketing rights to REMUNE in North America, Europe, Japan and certain other countries, if regulatory approvals are received. The Company and Agouron have conducted physician and patient focus group sessions to begin preparations for a commercial marketing launch of REMUNE, subject to the successful conclusion of the clinical trials and final approval of the product by the FDA. If REMUNE is successfully developed and approved for marketing, third party reimbursement will need to be sought for the costs of related treatments from government health administration authorities, private health coverage insurers, managed care organizations and other organizations. The two companies will share all profits from the commercialization of REMUNE on a 50/50 basis, if REMUNE is successfully developed and receives the necessary regulatory approvals. The Company also has partners for Thailand and South and Central America. IMMUNE-BASED THERAPIES FOR AUTOIMMUNE DISEASES BACKGROUND. Autoimmune disease results from the body's immune system manufacturing T cells and or antibodies that are directed against the body's own cells or organs as if they were foreign. Several autoimmune disorders, including rheumatoid arthritis, psoriasis and multiple sclerosis, result from the proliferation of misdirected T cells that incorrectly identify and destroy the individual's own tissue. TECHNOLOGY. The Company's proprietary autoimmune immune-based therapies under development are designed to inhibit or downregulate the T cells that the Company believes cause the tissue damage in certain autoimmune diseases. These therapies are designed to induce specific immune responses by inhibiting the disease-causing T cells. The Company's immune-based approach for the treatment of these autoimmune diseases is based on the immune system's ability to down regulate disease causing T cells. The Company is pursuing this approach for the treatment of rheumatoid arthritis, psoriasis and multiple sclerosis. The Company's products under development are T cell receptor peptide vaccines based on a combination of synthetic peptides from T cell receptors emulsified in IFA. BENEFITS OF OUR APPROACH. The Company believes that its approach to the treatment of autoimmune diseases may provide several advantages over existing therapies and competing approaches based on immune system regulation. In clinical studies, the Company's immune-based therapies using T cell receptor peptides have demonstrated a lack of toxicity and a specific impact on the disease-causing cells. These results, combined with the ease of administration through infrequent intramuscular injections (one to three month intervals) and the potential for a long-lasting immunity, may provide an important addition or alternative to existing therapies, which treat only the symptoms of the disease. While autoimmune diseases may involve any organ system, common targets include the lining of the joints in rheumatoid arthritis, the skin in psoriasis and the white matter of the brain and spinal cord in multiple sclerosis. Current treatments for these diseases address only the symptoms and are ineffective in halting the progressive tissue destruction caused by the autoreactive T cells. This progression often results in severe debilitation or death. RHEUMATOID ARTHRITIS BACKGROUND. Rheumatoid arthritis is a chronic inflammatory disease characterized by persistent inflammation of the lining of the joints accompanied by stiffness and pain or tenderness on motion. It is estimated that approximately 2.1 million individuals in the United States, and 1-2% of the worldwide population, suffer from rheumatoid arthritis, and up to $5.6 billion is spent annually worldwide on medications designed to treat only the symptoms of this debilitating disease. EXISTING THERAPIES. There is currently no cure for rheumatoid arthritis. Currently, management of rheumatoid arthritis requires early diagnosis and aggressive treatment before functional impairment and irreversible joint damage has occurred. Available therapies generally have adverse side effects and address only the symptoms of the disease. By contrast, the Company's rheumatoid arthritis therapy is intended to target and inhibit the specific T cells thought to be involved in initiating the disease process. The Company believes this inhibition may reduce the inflammatory events that occur as the disease progresses. 6 PRODUCT UNDER DEVELOPMENT. The treatment being developed is designed to stimulate the immune system of a rheumatoid arthritis patient to control the T cells that are initiating the disease. The Company believes that eliminating or inhibiting these T cells may prevent further damage to the tissue of joints. HUMAN CLINICAL TRIALS. Based on results observed in an earlier Phase 2 clinical trial, a Phase 2b clinical trial was conducted. The Phase 2b clinical trial, intended to confirm and expand upon the clinical results from an earlier completed Phase 2 clinical trial, included 340 individuals with rheumatoid arthritis who received treatment over 24-weeks at 26 clinical sites. The Company believes that the results from this Phase 2b trial suggest a favorable treatment effect according to the American College of Rheumatology (ACR) 20 improvement criteria with significance at one time point after the third injection. These findings were consistent with and expanded upon the results shown in the previous Phase 2 trial. The ACR 20 criteria require an improvement in tender and swollen joint counts of at least 20% from baseline, along with improvement in three of five other disease-related criteria. The results from this study also confirmed that the treatments were safe and well tolerated. The results of the Phase 2b clinical trial were presented at the American College of Rheumatology 1999 Annual Meeting. PSORIASIS BACKGROUND. Psoriasis is a chronic and recurrent proliferative disease of the skin characterized by irritating and sometimes painful, defined red patches covered with silvery-white scales. According to the National Psoriasis Foundation, psoriasis affects over 6 million Americans. Annual outpatient costs for treatment are currently estimated at up to $3 billion per year. A distinguishing feature of the disease is the rapid sloughing of skin layers. While normal skin cells mature in 28 to 30 days, skin cells of psoriasis patients move to the surface of the skin in approximately three to seven days. EXISTING THERAPIES. Current treatments, which range from topical ointments to phototherapy, address the symptoms of psoriasis rather than the cause of the disease. Not all treatments work for every individual. These treatments often require individuals to experiment and/or combine therapies in order to discover the regimen that is most effective. Treatment success requires faithful compliance to the regimen and provides varying degrees of relief from the disease. Patients usually have to cycle in and out of these therapies to achieve any therapeutic benefit. By contrast, the Company's psoriasis therapy is intended to target and inhibit the immune system cells that may be involved in the initiation of the disease process. PRODUCT UNDER DEVELOPMENT. The treatment being developed by the Company is designed to stimulate the immune system of a psoriasis patient to regulate the disease causing T cells. The Company believes that eliminating or inhibiting these T cells may alleviate the effects of this disease. HUMAN CLINICAL TRIALS. Based on results observed in an earlier Phase 2 clinical trial, a second Phase 2 clinical trial was conducted. This Phase 2 clinical trial involved 84 individuals with moderate to severe psoriasis and was designed to evaluate the safety and optimal dose of the therapy. The Company believes the results from this trial suggest that the groups that received intramuscular injections of T cell receptor peptides along with IFA showed clinical improvement according to the psoriasis and severity index (PASI) scores when compared to all other treatment groups. MULTIPLE SCLEROSIS BACKGROUND. Multiple sclerosis is a chronic disease of the central nervous system that effects the white matter of the brain and spinal cord. It is one of the most common causes of chronic neurologic disability in young adults. Multiple sclerosis afflicts approximately 350,000 individuals in the United States and more than 1 million individuals worldwide. EXISTING THERAPIES. The mechanism of action for currently approved therapies is not clearly understood. These therapies provide modest benefit for the disease and have many side effects. PRODUCT UNDER DEVELOPMENT. The Company's proprietary immune-based therapy under development for multiple sclerosis contains T cell receptor peptides specific for multiple sclerosis which were found in the cerebrospinal fluid of individuals afflicted with multiple sclerosis or because of the reactivity to myelin basic protein. HUMAN CLINICAL TRIALS. Based on results from an earlier Phase 1 clinical trial, a second Phase 1 open label trial was conducted in patients whose T cells were found to be present at significant levels in spinal fluid cultures of T cells. Ten patients received injections of the Company's therapeutic peptide vaccine over 48 weeks. The results suggest that the TCR therapeutic peptide vaccine was again safe and well tolerated, and it generated strong immune 7 responses in 8 out of 10 (80%) patients immunized. The patients remained clinically stable as measured by expanded disability status scores (EDSS) during the 48-week study. IMMUNE-BASED THERAPIES FOR CANCER BACKGROUND. Cancer is characterized by the uncontrolled growth of abnormal cells that can spread from the anatomic site of origin. This growth is due to alterations or mutations in a cell's DNA that leads to production of tumor associated antigens that are not adequately recognized by the immune system. Cancer vaccines are intended to optimize the patient's immune system's ability to recognize the antigens so that the immune system intensifies the attack on the cancer. Many cancers can be cured if they are detected early and treated promptly; others can be controlled for many years with a variety of treatment approaches. EXISTING THERAPIES. There are currently several ways to treat cancer, all of which have significant and often severe side effects. Surgery, radiation, chemotherapy, hormones and more recently, immunotherapy are most often used to treat cancer. Unfortunately, certain tumors are drug resistant from the beginning while others develop resistance with repeated treatments. The problem of drug resistance is particularly serious in chemotherapy where tumors develop resistance to multiple drugs after only one drug has been administered. TECHNOLOGY. Immune Response is focused on developing vaccines that will present tumor cells more effectively to the immune system. The Company's technology combines two different kinds of cell lines to make up the vaccine. One is a source of tumor antigens (tumor cell lines) and the other is a source of cytokine (genetically engineered skin or fibroblast cell line). The tumor cell lines are grown in the lab and not derived from individual patients - avoiding the need for patient-specific vaccines. The cytokine-producing fibroblast cell line allows production of a precise and consistent amount of cytokine - a molecule that can intensify the immune response. The combination of these two cell types in the vaccine appears to be essential for inducing the immunity needed to enable the immune system to attack and eradicate the cancer. The Company's technology allows for a controlled reproducible vaccine that is not patient specific. To further enhance the immune system to destroy the cancer, the Company is also developing complementary technology to provide cytokines, specifically GM-CSF, by constructing tumor cell lines that express the cytokine on the surface. The Company's goal is to combine these two platform technologies to develop cancer vaccines to treat colon, brain, melanoma, and prostate cancers. COLON CANCER BACKGROUND. Colon cancer is the second most frequently diagnosed cancer in the U.S. with nearly 100,000 new cases and 47,000 deaths expected yearly. Well over half of the patients are identified early enough for surgical intervention with the intent to cure. However, recurrence of the cancer following surgery is a major problem for about 40% of these patients. In addition, more effective treatments are needed for patients with advanced disease at time of presentation. HUMAN CLINICAL TRIALS. Based on promising initial clinical findings from an earlier Phase 1 study, a second Phase I trial was designed to test a tumor cell line vaccine in patients with late-stage metastatic colon cancer. Three established colon tumor cell lines were combined with a fibroblast cell line genetically engineered to express the IL-2 cytokine. Patients received three administrations intradermally (under the skin) over a twelve-week period. The study is designed to measure levels of Cytotoxic T Lymphocytes (CTL's) which specifically recognize and kill both the vaccinating tumor cells and/or the patient's own tumor cells. This twelve patient trial will be completed during 2000. BRAIN CANCER BACKGROUND. Each year, about 18,000 cases of high-grade gliomas are diagnosed in the United States, with the numbers increasing yearly in both adults and children. Prognosis for these patients is very poor. Surgical resections followed by either radiation or chemotherapy have done little to alter the fatality of this cancer. The mean life expectancy of patients with glioblastoma multiforme is only one year after its initial diagnosis and only several months following recurrence. The Company believes that novel immune-based treatments could fill a need in treating these cancers. HUMAN CLINICAL TRIALS. The Company is conducting a Phase 1 trial of a potential new tumor vaccine designed to induce the patient's immune system to recognize and destroy tumor cells, thereby preventing or delaying the recurrence of malignant brain tumors (glioblastoma multiforme and anaplastic astrocytoma). The study will enroll 8 12 patients who have just completed surgical resection and radiation treatment, currently the standard of care for newly diagnosed glioma patients. The trial will investigate the Company's platform vaccine technology that utilizes a fibroblast cell line genetically modified to secrete the GM-CSF cytokine mixed with irradiated brain tumor (glioma) cell lines. The three goals of the study are to evaluate the safety of multiple injections of this cell-line based vaccine, monitor the level of cellular and humoral (antibody) immune responses induced by the vaccine against the tumor and examine the effects of immunizations on clinical progression of the disease. MELANOMA (SKIN) CANCER BACKGROUND. According to the American Cancer Society, approximately 44,000 individuals in the United States were diagnosed with melanoma in 1999 and an estimated 7,300 deaths resulted from this disease. The major cause of melanoma is excessive exposure to the sun's ultraviolet rays. Despite good therapeutic effects by surgical intervention when detected early, there is no effective treatment for metastatic melanoma, and its 5 year survival rate is only 5%. Characterization of many established melanoma cell lines has been completed, and those lines intended for clinical testing have been selected. PROSTATE CANCER Prostate cancer will be newly diagnosed in 334,500 Americans this year, making it the most common cancer among men. Prostate cancer is the second leading cause of cancer deaths and the sixth leading cause of death overall among American men. This program is in the preclinical stages of development within the company. GENE THERAPY TECHNOLOGY. The Company is developing a targeted non-viral delivery technology for gene therapy. The Company maintains a strong proprietary position in non-viral technology for IN VIVO delivery of therapeutic genes to appropriate cells. Once inside the cell, the delivered plasmid DNA, or gene, is capable of performing its normal function, which is to encode for the production of a specific protein needed to alleviate a disease condition. Virtually any recombinant protein therapy currently being used could be transformed into a gene therapy. The Company believes non-viral delivery may have several advantages over current therapies including safety over viral delivery systems, versatility to treat different diseases with the same technology, dosing schedule, manufacturability, and cost. Most other competitive gene therapy delivery systems use disabled viruses to carry the gene to the cell nucleus, and are inherently immunogenic. HEMOPHILIA BACKGROUND. Hemophilia A, a hereditary blood clotting disorder, results from the dysfunction or absence of the Factor VIII protein. Approximately one of every 5,000 live male births worldwide results in a child afflicted with hemophilia A. Current treatments for hemophilia A are expensive. In preclinical mouse models, the Company's GeneDrug technology system has produced therapeutic concentrations of Factor VIII by delivering the gene that produces this protein. After delivery to cells that normally produce this protein, the liver cells, the Factor VIII protein was expressed and secreted into the bloodstream at therapeutic levels on a continuous basis for several weeks. If successfully developed, this product could potentially eliminate the need for daily injections of Factor VIII protein to control the regular bleeding episodes associated with hemophilia by allowing the patient to receive periodic injections of the Company's GeneDrug in order to maintain therapeutic levels of Factor VIII. In addition to gene delivery, the Company is focused on gene potency. Gene potency is the ability of the gene to generate high levels of its corresponding protein once inside the cell. Recently, Company scientists completed the synthesis of a new human Factor VIII gene that has increased potency and which contains organ-specific elements that only allow its expression in liver cells. HEPATITIS BACKGROUND. Hepatitis B is a viral infection of the liver. As many as 1.25 million Americans are chronically infected with hepatitis B virus ("HBV") and there are up to 320,000 new cases of HBV infection each year. Hepatitis C virus ("HCV") was recently identified as the major cause of non-A/non-B hepatitis. As many as 3.9 million Americans are chronically infected with this virus and there are up to 180,000 new cases of HCV infection each year. Recombinant interferon-alpha (IFN-(alpha)) is currently approved for treatment of both HBV and HCV. Many patients treated with recombinant IFN-(alpha) do not respond and whether there is a long-term benefit among those who have responses is uncertain. The Company's GeneDrug system is designed to be an improvement over current interferon therapy by achieving continuous, low-level expression and secretion of the protein specifically in liver cells. In preclinical mouse models, 9 the GeneDrug system has successfully achieved expression of interferon protein at therapeutic levels that persist for several months. If successfully developed, this could eliminate the need for numerous frequent injections of recombinant interferon protein by allowing patients to receive periodic injections of GeneDrug. The Company entered into a research collaboration in July 1998 with Schering Corporation to deliver their genes for IFN-(alpha) using the Company's gene delivery technology for the treatment of hepatitis. Schering Corporation's obligation to fund under the collaboration had expired as of December 31, 1999. NEW GENE DISCOVERY BACKGROUND. The Company recently completed a series of biochip studies as part of a gene discovery effort in the gene therapy program. Gene expression monitoring using microarrays (biochips) was conducted in several biological models of central and peripheral nervous system growth, differentiation and trauma including spinal cord injury. Over 3,000 significant gene changes were categorized to a gene expression database being assembled for new drug targets and functional gene discovery. Gene expression, especially knowing what genes are upregulated or downregulated, is crucial to the understanding of gene function. Since genes are involved in biological processes, knowing gene function could lead to new drug discovery. New gene discovery compliments the existing efforts in non-viral gene delivery by potentially supplying genes or gene products that may be proprietary to the Company for gene therapy. MANUFACTURING The Company has established a pilot manufacturing facility at its headquarters in Carlsbad, California for the production of the immune-based therapies. This facility is expected to be adequate to supply limited clinical trial quantities for these therapies. Additional manufacturing capacity for autoimmune disease and cancer will be needed for commercial scale production, if these therapies are approved for commercial sale. For the manufacture of the autoimmune disease therapies under development, the Company obtains synthetic peptides from third party manufacturers. The Company believes that the synthetic peptides and other materials necessary to produce the autoimmune disease therapies are readily available from various sources, and several suppliers are capable of supplying the autoimmune disease peptides in both clinical and commercial quantities. PATENTS REMUNE - HIV THERAPY. In 1993, the Company received a United States patent relating to REMUNE. In 1998 and 1999, additional patents were issued relating to certain products and methods. The Company has also received similar patents in Australia, certain European countries, Japan and Russia. The Company has additional patent applications relating to REMUNE on file in the United States, as well as in other countries. The patent applications cover, in part, certain products and methods of their use for the immunotherapeutic treatment of HIV-infected patients and/or preventive treatment of uninfected individuals. There can be no assurance that any additional HIV-related patents will be issued to the Company. Further, there can be no assurance that the issued patents, or any patent that may be issued in the future, will survive opposition or provide meaningful proprietary protection. AUTOIMMUNE DISEASES. During January 1994, the European Patent Office granted the Company a patent covering processes for vaccinating against diseases resulting from pathogenic responses by specific T cell populations. In March 1997, the Company was issued a patent covering this technology in the United States. In May 1994, the Australian Industrial Property Organisation accepted a similar application of the Company. In November 1998 and January 1999, the Company was issued two additional United States patents directed to this technology. These patents include composition and method claims for the prevention or treatment of certain autoimmune diseases, such as rheumatoid arthritis and proliferative T cell diseases. In December 1999, the Company obtained exclusive rights to the T cell receptor intelllectual property of Connetics Corporation and XOMA, (US) LLC, creating a broader platform for the potential development of products to treat chronic connective tissue and autoimmune diseases such as rheumatoid arthritis, psoriasis and multiple sclerosis. The Company also has patents and patent applications relating to its autoimmune technology on file in the United States and other countries, including members of the European Patent Convention and Japan. These patent applications cover certain compositions and methods relating to the use of T cell receptor peptide sequences to vaccinate against autoreactive T cells involved in autoimmune disease. There can be no assurance that any further autoimmune disease patents will be issued to the Company or that any issued patents, or any patent that may be issued in the future, will survive opposition or provide meaningful proprietary protection. We are aware that AstraZeneca PLC has acquired the rights to a patent, which has been issued in Europe and other countries, that may interfere with our ability to develop some of our technologies related to autoimmune disease if the patent is upheld after current opposition proceedings. The Company is in discussions with AstraZeneca PLC to resolve any conflict between the Company's and AstraZeneca's patent. However, there can be no assurance that a cross license or other resolutions satisfactory to the Company will result. 10 A failure to resolve this dispute in a manner favorable to the Company could have a material adverse effect on the Company. In March 1998, the Company successfully defended its European patent with respect to its immune-based therapies for autoimmune disease technology that was under opposition; although this decision can be appealed, the patent is presently enforceable. CANCER PROGRAM. Technologies for genetically modifying fibroblasts with cytokine genes or for modifying tumor cells with genes to inhibit TGF-(beta) production has been exclusively licensed to the Company from Sidney Kimmel Cancer Center (SKCC). SKCC has issued patents and has applied for patent protection in the United States and Europe related to the technologies licensed exclusively to the Company. There can be no assurance that the issued patents, or any patent that may be issued in the future, will survive opposition or provide meaningful proprietary protection. In April 1999 the Company received a patent for Membrane-Bound Cytokine Compositions Comprising GM-CSF (granulocyte-macrophage colony stimulating factor) and Methods of Modulating an Immune Response Using Same. The Company has licensed exclusive rights to the technologies for inhibiting TGF-(beta) via expressed antisense for lung cancer and licensed exclusive rights to the IL3 radiosensitization in several cancers, including prostate cancer but excluding colon cancer. There can be no assurance that the issued patents, or any patent that may be issued in the future, will survive opposition or provide meaningful proprietary protection. GENE THERAPY. In November 1992, the Company obtained an exclusive license to a United States patent, received by the University of Connecticut, covering the Company's core gene delivery system technology, including methods and compositions for delivering DNA to the liver via receptors on the surface of liver cells. In addition, during 1997 and 1999, two related United States patents issued, extending the Company's gene delivery protection to include the delivery of any polynucleotide to any mammalian cell via any internalizing cell surface receptor. Thus, the Company's patent protection in the United States is no longer limited to the delivery of genes to the liver. In 1999 a similar patent issued in Europe. In 1998, a corresponding Japanese patent application also issued, covering the delivery of any polynucleotide to mammalian cells via non-protein (e.g., synthetic) liver-specific ligands. The Company also licenses and owns a number of issued United States and foreign patents covering the delivery of specific genes and polynucleotides to cells using their proprietary technology, as well as formulations tailored for such delivery. For example, the Company owns a United States patent covering the targeted delivery of antisense polynucleotides to cells to treat Hepatitis B infection. The Company also licensed an allowed European patent application covering the targeted delivery to cells of genes encoding secretory proteins, including blood coagulation factors, to treat hemophilia. The Company continues to file patent applications covering novel genes and other aspects of its proprietary gene delivery technology, which the Company develops. The Company is presently seeking to obtain licenses for certain genes from several different third parties. There can be no assurance that the Company will be able to obtain such licenses on commercially favorable terms, if at all, and if these licenses are not obtained, the Company might be prevented from using certain of its technologies. The Company's failure to obtain a license required to continue practicing its own technologies would have a material adverse effect on the Company. There can be no assurance that any additional gene therapy patents will be issued to the Company. Further, there can no assurance that the issued patents, or any patent that may be issued in the future, will survive opposition or provide meaningful proprietary protection. COMPETITION HIV. The Company is engaged in segments of the biopharmaceutical industry, including the treatment of HIV, that are intensely competitive and rapidly changing. If successfully developed and approved the product candidates and compounds that the Company is currently developing will compete with numerous existing therapies. For example, there are at least 11 drugs currently approved for the treatment of HIV. In addition, a number of companies are pursuing the development of novel pharmaceutical products that target the same diseases that the Company is targeting, and some companies, including several multinational pharmaceutical companies, are simultaneously marketing several different drugs and may therefore be able to market their own combination drug therapies. The Company believes that a significant number of drugs are currently under development and will become available in the future for the treatment of HIV. Although the Company believes that there is a significant future market for therapeutics to treat HIV and other viral diseases, the Company anticipates that even if it successfully develops REMUNE and REMUNE is approved for marketing, it will face intense and increasing competition in the future as new products enter the market and advanced technologies become available. There can be no assurance that existing products or new products for the 11 treatment of HIV developed by the Company's competitors, including Glaxo Wellcome, plc, Merck & Co. and Abbott Laboratories, will not be more effective, or more effectively marketed and sold, than REMUNE, should it be successfully developed and receive regulatory approval, or any other therapeutic for HIV that may be developed by the Company. Competitive products or the development by others of a cure or new treatment methods may render the Company's technologies and products and compounds obsolete, noncompetitive or uneconomical prior to the Company's recovery of development or commercialization expenses incurred with respect to any such technologies or products or compounds. Many of the Company's competitors have significantly greater financial, technical and human resources than the Company and may be better equipped to develop, manufacture, sell, market and distribute products. In addition, many of these companies have extensive experience in preclinical testing and clinical trials, obtaining FDA and other regulatory approvals and manufacturing and marketing pharmaceutical products. For use individually or in combination therapy, many of these competitors also have products that have been approved or are in late-stage development and operate large, well-funded research and development programs. Smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large pharmaceutical and biotechnology companies. Furthermore, academic institutions, governmental agencies and other public and private research organizations are becoming increasingly aware of the commercial value of their inventions and are more actively seeking to commercialize the technology they have developed. New developments in areas in which the Company is conducting its research and development are expected to continue at a rapid pace in both industry and academia. If the Company's product candidates and compounds are successfully developed and approved, the Company will face competition based on the safety and effectiveness of its products and compounds, the timing and scope of regulatory approvals, availability of manufacturing, sales, marketing and distribution capabilities, reimbursement coverage, price and patent position. There can be no assurance that the Company's competitors will not develop more effective or more affordable technology or products, or achieve earlier patent protection, product development or product commercialization than the Company. Accordingly, the Company's competitors may succeed in commercializing products more rapidly or effectively than the Company, which could have a material adverse effect on the Company's business, financial condition and results of operations. TREATMENTS FOR AUTOIMMUNE DISEASE. Several emerging technologies related to immune system regulation, if successfully developed, could compete with the Company's autoimmune disease treatments under development. The Company believes that its principal competition in the autoimmune disease area will come from companies conducting research in the areas of T cell receptors, interaction between T cells and the target antigen and tissue, specific targeting of activated T cell populations, and mechanisms of tolerance including oral tolerance approaches. Scientific reports on T cell receptor research have also discussed approaches similar to that of the Company. TREATMENTS FOR CANCER. New cancer therapies are being developed by a number of individual investigators and companies. Some of these approaches involve modification of tumor cells with a variety of cytokines, which approaches may prove competitive with the technologies being developed by the Company. Many of the Company's competitors have substantially greater experience, financial and technical resources and production, marketing and development capabilities than the Company. There can be no assurance that competitors have not or will not succeed in developing technologies and products more quickly or that are more effective than any which have been or are being developed by the Company or which would render the Company's technology and products obsolete and noncompetitive. GENE THERAPY. The Company believes that competition in the treatment of the diseases targeted by its gene therapy program will be of two types: chronic treatment with pharmaceutical products; and other gene therapy systems under development for insertion of the correct gene. There currently exist a number of approved therapies for treatment of hemophilia, and hepatitis B and C. Both purified and recombinant forms of Factor VIII have been approved by the FDA for treatment of hemophilia and are effective in stopping bleeding episodes. Interferon alpha-2b is currently approved for treatment of chronic hepatitis B and C. Other interferons are being tested for the treatment of viral hepatitis. In addition to interferons, a variety of nucleoside analogs have been tested for treatment of chronic hepatitis B, including 3TC. Several major pharmaceutical companies are investigating gene therapy treatments for the delivery of proteins to treat these diseases. If these prove effective, they may compete with the Company's gene delivery therapies. Many of the Company's competitors have substantially greater experience, financial and technical resources and production, marketing and development capabilities than the Company. There can be no assurance that competitors have not or will not succeed in developing technologies and products more quickly or that are more effective than 12 any which have been or are being developed by the Company or which would render the Company's technology and products obsolete and noncompetitive. GOVERNMENT REGULATION Clinical testing, manufacture, promotion and sale of the Company's drug products are subject to extensive regulation by numerous governmental authorities in the United States, principally the FDA, and corresponding state and foreign regulatory agencies. The Company believes that REMUNE and most of its other potential immune-based therapies will be regulated by the FDA as biological drug products under current regulations of the FDA. Biological products must be shown to be safe, pure and potent (i.e., effective) and are subject to the same regulatory requirements as nonbiological products under the Food and Drug Administration Act ("FDA Act"), as amended by the Food and Drug Administration Modernization Act of 1997 ("FDA Modernization Act"), except that a biological product licensed under the PHS Act ("PHS Act") is not required to have an approved New Drug Application ("NDA") under the Federal Food, Drug and Cosmetic Act ("FDC Act"). The FDA Modernization Act directed the FDA to take measures to minimize the differences in the review and approval of marketing applications for biological and nonbiological products. The FDA Modernization Act also made significant revisions to the statutory requirements with regard to the approval of new biologics and nonbiological products. Among other things, the FDA Modernization Act established a new statutory program for the approval of fast track drugs, streamlined clinical research, and revised the content of product approval applications and the FDA review process. The FDA is required to issue regulations and guidelines in order to implement certain of these new requirements. Until the FDA implements these regulations and guidelines, it is impossible to predict the impact of the FDA Modernization Act on the review and approval of any marketing applications that the Company may submit to the FDA in the future. The FDC Act, the PHS Act and other federal and state statutes and regulations govern or influence the testing, manufacture, safety, effectiveness, labeling, storage, recordkeeping, approval, advertising, distribution and promotion of biological prescription drug products. Noncompliance with applicable requirements can result in, among other things, fines, injunctions, seizure of products, total or partial suspension of product marketing, failure of the government to grant premarket approval, withdrawal of marketing approvals and criminal prosecution. The steps required before a biological drug product may be marketed in the United States generally include preclinical studies and the filing of an IND application with the FDA, which must become effective pursuant to FDA regulations before human clinical trials may commence. Reports of results of preclinical studies and clinical trials for biological drug products are submitted to the FDA in the form of a Biologics License Application (the "BLA") for approval for marketing and commercial shipment. Submission of a BLA does not assure FDA approval for marketing. The BLA review process may take a number of years to complete, although reviews of applications for treatments of AIDS, cancer and other life-threatening diseases may be accelerated or expedited. Failure of the Company to receive FDA marketing approval for REMUNE or any of its other products under development on a timely basis could have a material adverse effect on the Company's business, financial condition and results of operations. In the past, in addition to obtaining approval for each biological drug product, an Establishment License Application (the "ELA") usually was required to be filed and approved by the FDA. However, the FDA Modernization Act repealed the statutory requirement for an ELA for a biological product. Now only a single BLA covering both the biological product and the facility in which the product is manufactured is required. The FDA also has been directed by the FDA Modernization Act to take measures to minimize the differences in the review and approval of biological drugs required to have approved BLAs under the PHS Act and nonbiological drugs required to have approved NDAs under the FDC Act. Among the other requirements for BLA approval is the requirement that prospective manufacturers conform to the Good Manufacturing Practices (the "GMP") regulations specifically for biological drugs, as well as for other drugs. In complying with the GMP regulations, manufacturers must continue to expend time, money and effort in production, recordkeeping and quality control to assure that the product meets applicable specifications and other requirements. The FDA periodically inspects biological drug product manufacturing facilities in order to assure compliance with applicable GMP requirements. Failure to comply with the GMP regulations subjects the manufacturer to possible FDA regulatory action, such as the suspension of manufacturing, product recall or seizure, injunction and criminal prosecution. There can be no assurance that the Company or its contract manufacturers, if any, will be able to maintain compliance with the GMP regulations on a continuing basis. Failure to maintain such compliance could have a material adverse effect on the Company's business, financial condition and results of operations. 13 The Company believes its proprietary GeneDrug and cancer treatment therapies also will likely be regulated as biological products. This is because the Company's gene products are subject to the FDA's industry guidance for Human Somatic Cell Therapy and Gene Therapy, which was issued by the FDA in March 1998 (the "1998 Guidance"), as well as earlier FDA notices on this subject. The 1998 Guidance confirms that gene therapy products will be regulated by the FDA as biological products subject to biological product licensure requirements. In addition, the 1998 Guidance describes FDA concerns regarding production, quality control testing, and the administration of recombinant vectors for gene therapy. No assurance exists that the Company or its suppliers can successfully address all of the concerns of the 1998 Guidance with respect to gene therapy products. In addition, since issuance of the 1998 Guidance there have been developments relating to adverse patient reactions in gene therapy trials that have led to increased FDA scrutiny of all gene therapy research. No assurance exists that the Company can successfully respond to the more rigorous requirements prompted by that scrutiny. As with the Company's other potential products, the gene therapy products will be subject to extensive FDA regulation throughout the product development process, and there can be no assurance that any of these products will be successful at securing the requisite FDA marketing approval on a timely basis, if at all. The preclinical and clinical testing process to obtain FDA approval of a biological drug is expensive and time consuming. Preclinical studies are conducted in animals usually to evaluate the potential safety of a product. The results of preclinical studies are submitted to the FDA as part of the IND application, which must become effective pursuant to FDA regulations before human clinical trials may begin. Human clinical trials typically are conducted in three phases and are subject to detailed protocols. Each protocol indicating how the clinical trial will be conducted must usually be submitted for review to the FDA as part of the IND application. The FDA's review of a trial protocol does not necessarily mean that, if the trial is completed, it will constitute proof of safety or efficacy (including potency). Further, each clinical trial must be conducted under the auspices of an independent Institutional Review Board ("IRB") established pursuant to FDA regulations. The IRB considers, among other things, ethical concerns, informed consent requirements and the possible liability of the institution conducting the trials. The FDA or IRB may require changes in a protocol both prior to and after the commencement of a clinical trial. There is no assurance that the IRB or FDA will permit a trial to go forward or, once started, to be completed. The three phases of clinical trials are generally conducted sequentially, but they may overlap. In Phase 1, the initial introduction of the drug into humans, the drug is tested for safety, side effects, dosage tolerance, metabolism and clinical pharmacology. Phase 1 testing for an indication typically takes at least one year to complete. Phase 2 involves controlled tests in a large but still limited patient population to determine the preliminary effectiveness of the drug for specific indications, to determine optimal dosage and to identify possible side effects and safety risks. Phase 2 trials typically take at least from one and one-half to two and one-half years to complete. If preliminary evidence suggesting effectiveness has been obtained during Phase 2 evaluations, expanded Phase 3 trials are undertaken to gather the additional information about safety and effectiveness that is needed to evaluate the overall benefit-risk relationship of the product and to provide an adequate basis for physician labeling. Phase 3 trials for an indication generally take from two and one-half to five years to complete. There can be no assurance that Phase 1, Phase 2 or Phase 3 testing will be completed successfully within any specified time period, if at all, with respect to any of the Company's products that have not completed any such testing. Nor can there be any assurance that completion of clinical testing will result in FDA approval. Furthermore, the FDA may suspend clinical trials at any time if the patients are believed to be exposed to a significant health risk. The FDA Modernization Act amended the FDC Act to streamline clinical research on biological and nonbiological drugs. Under the new law, a clinical investigation may begin 30 days after the FDA receives an IND application containing information about the drug and clinical investigation that includes: 1. Information about the design of the investigation and adequate reports of basic information, certified by the applicant, necessary to assess the drug's safety in a clinical trial 2. Adequate information on the chemistry and manufacturing of the drug, controls available for the drug and primary data tabulations from animal or human studies. The FDA is authorized to halt a clinical study at any time by issuing a clinical hold, confirmed in writing, prohibiting the sponsor from conducting the investigation. The clinical hold may be issued based on the FDA's determination that the drug presents an unreasonable risk to the safety of the research subjects, taking into account the qualifications of the investigators, information about the drug, the design of the clinical investigation, the conditions for which the drug is to be investigated, and the health status of the subjects. Clinical holds also may be imposed by the FDA for other reasons, as established by regulations. The new law, however, largely codifies current regulations 14 albeit with several significant changes. First, it potentially reduces the amount of data required to be submitted as part of an IND (most importantly by sanctioning the use of "primary data tabulations from animal and human studies" rather than full reports from such studies). Second, it codifies the procedural safeguards for issuance of clinical holds and strengthens certain rights of the manufacturer, including the right to obtain a written decision from the FDA regarding the removal of a clinical hold within 30 days of a written request from the IND sponsor. Under the FDA's current IND regulations, a number of procedures are available to expedite approval or to allow expanded access to investigational drugs. Certain investigational drugs, including products for the treatment of AIDS, can be distributed outside of traditional IND requirements on a "treatment" basis. Generally, the FDA may permit an investigational drug, including an investigational biological drug, to be used for "treatment" of patients outside of controlled clinical trials, if: (1) the drug is intended to treat a serious or immediately life-threatening disease; (2) there is no comparable or satisfactory alternative drug or other therapy available to treat that stage of the disease in the intended patient population; (3) the drug is under investigation in a controlled clinical trial, or all clinical trials have been completed; and (4) the sponsor of the controlled clinical trial is actively pursuing marketing approval of the investigational drug with due diligence. Although the FDA has granted expanded access to REMUNE for those patients who are ineligible to enroll in the Phase 3 clinical endpoint trial, the FDA has to date not designated expanded access protocols for REMUNE as "treatment" protocols. Either expanded access or a treatment protocol designation might permit third party reimbursement of some of the costs associated with making REMUNE available to patients in such an expanded access context. There can be no assurance that the FDA will determine that REMUNE meets all of the FDA's criteria for use of an investigational drug for treatment use or that, even if the product is allowed for treatment use, that third party payers will provide reimbursement for any of the costs of REMUNE treatment. The FDA Modernization Act also amended the FDC Act to permit expanded access to individuals and larger groups to unapproved new therapeutic and diagnostic products. Although it largely codified existing FDA regulations in this area, it expands access to all investigational therapies. First, it allows the FDA to authorize the emergency shipment of investigational new drugs for the diagnosis, monitoring, or treatment of a serious disease or condition. Second, it permits any person, through a licensed physician, to request and obtain from a manufacturer or distributor an investigational drug for the diagnosis, monitoring, or treatment of a serious disease or condition if the following conditions are met: 1. A comparable or satisfactory alternative therapy is not available. 2. There is sufficient evidence of the drug's safety and effectiveness to permit such use. 3. The use will not interfere with the conduct of clinical investigations to support marketing approval. 4. A clinical protocol is submitted to the FDA describing the use of the investigational drug in a single patient or small group of patients. The law also authorizes expanded patient access to investigational drugs under a treatment IND application. The FDA also has issued regulations to accelerate the approval of or to expedite the review of new biological drug products for serious or life-threatening illnesses that provide meaningful therapeutic benefit to patients over existing treatments (e.g., the ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy). Under the accelerated approval program, the FDA may grant marketing approval for a biological or nonbiological drug product earlier than would normally be the case, based on an effect on a surrogate endpoint or a clinical endpoint other than survival. Under the program, the sponsor must agree to conduct postmarketing studies to verify and describe the clinical benefits of the product. In addition to the accelerated approval process, the FDA has established procedures designed to expedite the development, evaluation and marketing of new therapies intended to treat persons with life-threatening and severely debilitating illnesses, especially when no satisfactory alternative therapy exists. The term "life-threatening" is defined by the FDA to mean: (1) disease or conditions where the likelihood of death is high unless the course of the disease is interrupted and (2) diseases or conditions with potentially fatal outcomes, where the endpoint of clinical trial analysis is survival. "Severely debilitating" is defined by the FDA to mean diseases or conditions that cause major irreversible morbidity. As a condition of approval, the FDA may require the sponsor to conduct certain postmarketing studies to delineate additional information about the drug's risks, benefits and optimal use. The FDA Modernization Act established a new statutory program for the approval of fast track drugs, including biological products. Fast track drugs are defined as new drugs or biological products intended for the treatment of serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs for such conditions. Under the fast track program, a request for designation may be submitted concurrently with, or any time after, submission of an IND application. If a product meets the statutory criteria, the FDA is required to designate the product as a fast track drug within 60 days of the request for designation. A BLA or NDA for a fast track drug may be approved by the FDA upon a determination that the drug has an effect on a clinical endpoint or a surrogate endpoint that is reasonably likely to 15 predict clinical benefits. The FDA can condition approval of a fast track drug upon a requirement to conduct post-approval studies and submit copies of promotional materials to the FDA prior to dissemination. The law also provides procedures for the expedited withdrawal of marketing approval of a fast track. There can be no assurance that the FDA will consider REMUNE, or any other of the Company's products under development, to be an appropriate candidate for accelerated approval, expedited review or fast track designation. Since 1992, non-biological and biological drugs have been subject to the Prescription Drug User Fee Act of 1992 ("PDUFA"). PDUFA requires that companies submitting marketing applications for such products pay fees in connection with review of the applications. In return, the FDA has committed to reviewing a certain percentage of the applications within certain timeframes. For example, in its Fiscal Year 1999 Report to Congress on PDUFA, the FDA reported that 98% of all original premarketing applications for biological and nonbiological drugs received in Fiscal Year 1999 were reviewed within 12 months of the application submission date. The FDA's PDUFA performance goal in Fiscal Year 1999 was to complete 90% of such applications within 12 months of the submission date. Although PDUFA was scheduled to expire on September 30, 1997, the Food and Drug Administration Modernization Act of 1997 reauthorized PDUFA for five years (i.e., until September 30, 2002). The FDA has committed for Fiscal Year 2000 to reaching approval, disapproval or additional-data-required decisions on 90% of standard original NDAs and to act on 50% of those submissions within 10 months. The FDA has also agreed to act on 90% of BLAs filed during fiscal year 2000 within 12 months of receipt of the marketing application and to review and act on 90% of priority original NDAs and BLAs (i.e., applications offering significant advances over existing treatments) within six months of receipt. There can be no assurance, however, that any BLA the Company submits to the FDA for any of its biological products will be reviewed and acted upon within the timeframes set out above. The Company also is subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other present and potential future federal, state or local regulations. Regulations concerning biotechnology may affect the Company's research and development programs. Furthermore, existing or additional government regulations may be applied that could prevent or delay regulatory approval of the Company's products, or affect the pricing or distribution of such products. The Company also is subject to foreign regulatory requirements governing human clinical trials and pharmaceutical sales that vary widely from country to country. Whether or not FDA approval has been obtained, approval of a product by comparable regulatory authorities of foreign countries must be obtained prior to marketing the product in those countries. The approval process may be more or less rigorous from country to country and the time required may be longer or shorter than that required in the United States. The Company may seek to use foreign marketing partners to assist in obtaining foreign regulatory approval for REMUNE and other products. EMPLOYEES As of December 31, 1999, the Company and its subsidiary had a combined 103 full-time employees, of whom 17 hold Ph.D. or other advanced degrees. Of these employees, 78 are engaged in, or directly support, research and development. A significant number of the Company's management and professional employees have had prior experience with pharmaceutical and biotechnology companies. None of the Company's employees are covered by a collective bargaining agreement. RISK FACTORS THE FAILURE TO SUCCESSFULLY DEVELOP AND COMMERCIALIZE PRODUCTS MAY CAUSE US TO CEASE OPERATIONS. We have not completed the development of any products. A failure to successfully develop and commercialize products may cause us to cease operations. Our potential therapies under development will require significant additional research and development efforts and regulatory approvals prior to potential commercialization. The discontinuation of the Phase 3 trial of REMUNE due to lack of efficacy has had a material adverse effect on us. If Agouron Pharmaceuticals, Inc. fails to initiate or successfully complete additional pivotal trials with REMUNE we may have to abandon REMUNE or seek additional funding. Our other therapies and technologies are at earlier stages of development than REMUNE. Some of our technologies have not yet been tested in humans. Human testing of potential products based on these technologies may not be permitted by regulatory authorities. Even if human testing is permitted, the products based on these technologies may not be successfully developed or be shown to be safe and efficacious. Potential immune-based therapies based on some of our technologies are at an early stage of clinical testing and may not be shown to be safe or efficacious or ever receive regulatory approval. 16 The results of our preclinical studies and clinical trials may not be indicative of future clinical trial results. A commitment of substantial resources to conduct time-consuming research, preclinical studies and clinical trials will be required if we are to develop any products. Delays in planned patient enrollment in our clinical trials may result in increased costs, program delays or both. None of our potential products may prove to be safe and effective in clinical trials. FDA or other regulatory approvals may not be obtained and even if successfully developed and approved, our products may not achieve market acceptance. Any products resulting from our programs are not expected to be successfully developed or commercially available for a number of years, if at all. Unacceptable toxicities or side effects may occur at any time in the course of human clinical trials or, if any products are successfully developed and approved for marketing, during commercial use of our products. The appearance of any unacceptable toxicities or side effects could interrupt, limit, delay or abort the development of any of our products or, if previously approved, necessitate their withdrawal from the market. OUR ADDITIONAL FINANCING REQUIREMENTS AND LIMITED ACCESS TO FINANCING MAY ADVERSELY AFFECT OUR ABILITY TO DEVELOP PRODUCTS We will need to raise additional funds to conduct research and development, preclinical studies and clinical trials necessary to bring our potential products to market and establish manufacturing and marketing capabilities. A failure to raise additional funds would require us to scale back or eliminate some or all of our research and development programs or license to third parties products or technologies that we would otherwise seek to develop ourselves. We believe that our existing resources will enable us to maintain our current and planned operations only into the first half of 2001. Although we anticipate that the REMUNE development will continue to represent a significant portion of our overall expenditures, we also anticipate that costs related to the development of REMUNE will decrease in 2000. Other anticipated costs with respect to REMUNE will depend on many factors, in particular the continuation of our collaboration with Agouron. Our future capital requirements will depend on many factors, including: - continued scientific progress in our research and development programs, - the scope and results of preclinical studies and clinical trials, the time and costs involved in obtaining regulatory approvals, - the costs involved in filing, prosecuting and enforcing patent claims, - competing technological and market developments, - the cost of manufacturing scale-up, - effective commercialization activities and arrangements, and - other factors not within our control. We intend to seek additional funding through public or private financings, arrangements with corporate collaborators or other sources. If funds are acquired through additional collaborations, we will likely be required to relinquish some or all of the rights to products that we may have otherwise developed ourselves. If adequate funds are not available when needed or on terms acceptable to us, we may be required to scale back some or all of our research and development programs or license to third parties products or technologies that we would otherwise seek to develop ourselves. IF AGOURON PHARMACEUTICALS, INC. TERMINATES ITS COLLABORATION WITH US WE MAY HAVE TO ABANDON REMUNE Our binding Letter of Intent with Agouron is the primary collaborative agreement that provides us with contract revenue. The termination of our agreement with Agouron might require us to abandon REMUNE. Agouron has been acquired by Warner-Lambert Company. We do not know which Agouron research products Warner-Lambert Company will continue to fund in the future. WE MAY NOT BE ABLE TO ENTER INTO ADDITIONAL COLLABORATIONS OR MAINTAIN EXISTING ONES We intend to seek additional collaborative arrangements to develop and commercialize our products. We may not be able to negotiate collaborative arrangements on favorable terms, or at all, in the future and our current or future collaborative arrangements may not be successful or continue. Under the Schering Corporation collaboration, Schering 17 Corporation's obligation to fund had expired on December 31, 1999. Without funding arrangements, it may cause us to abandon some of our products under development. OUR PATENTS AND PROPRIETARY TECHNOLOGY MAY NOT PROVIDE US WITH ANY BENEFIT AND THE PATENTS AND PROPRIETARY TECHNOLOGY OF OTHERS MAY PREVENT US FROM COMMERCIALIZING PRODUCTS A failure to obtain meaningful patent protection for our potential products and processes would greatly diminish the value of our potential products and processes. In addition, whether or not our patents are issued, or issued with limited coverage, others may receive patents which contain claims applicable to our products. We are aware that AstraZeneca PLC has acquired the rights to a patent, which has been issued in Europe and other countries, that may interfere with our ability to develop some of our technologies related to autoimmune disease if the patent is upheld after current opposition proceedings. This patent, and others that we are not aware of, may adversely affect our ability to develop and commercialize products. The patent positions of biotechnology and pharmaceutical companies can be highly uncertain, and involve complex legal and factual questions. Therefore, the breadth of claims allowed in biotechnology and pharmaceutical patents cannot be predicted. We also rely upon unpatented trade secrets and know how, and others may independently develop substantially equivalent trade secrets or know how. We also rely on protecting our proprietary technology in part through confidentiality agreements with our corporate collaborators, employees, consultants and certain contractors. These agreements may be breached and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or independently discovered by our competitors. Our products and processes may infringe, or be found to infringe, patents not owned or controlled by us, such as the patent owned by AstraZeneca PLC. If relevant claims of third-party patents are upheld as valid and enforceable, we could be prevented from practicing the subject matter claimed in the patents, or would be required to obtain licenses to redesign our products or processes to avoid infringement. Licenses may not be available at all or on terms commercially reasonable to us and we may not be able to redesign our products or processes to avoid infringement. Litigation may be necessary to defend against claims of infringement, to enforce patents issued to us or to protect trade secrets. Litigation could result in substantial costs and diversion of management efforts regardless of the results of the litigation. An adverse result in litigation could subject us to significant liabilities to third parties, require disputed rights to be licensed or require us to cease using some technology. OUR HISTORY OF OPERATING LOSSES AND OUR EXPECTATIONS OF CONTINUING LOSSES MAY HURT OUR ABILITY TO CONTINUE OPERATIONS As of December 31, 1999 we had a consolidated accumulated deficit of $186.5 million. We have not generated revenues from the commercialization of any product. We expect to incur substantial net operating losses over the next several years which may imperil our ability to continue operations. We may not be able to generate sufficient product revenue to become profitable at all or on a sustained basis. THE LENGTHY APPROVAL PROCESS AND UNCERTAINTY OF GOVERNMENT REGULATORY REQUIREMENTS MAY DELAY OR PREVENT US FROM COMMERCIALIZING PRODUCTS Clinical testing, manufacture, promotion and sale of our products are subject to extensive regulation by numerous governmental authorities in the United States, principally the FDA, and corresponding state and foreign regulatory agencies. This regulation may delay or prevent us from commercializing products. Noncompliance with applicable requirements can result in, among other things, fines, injunctions, seizure of products, total or partial suspension of product marketing, failure of the government to grant premarket approval, withdrawal of marketing approvals and criminal prosecution. The regulatory process for new therapeutic drug products, including the required preclinical studies and clinical testing, is lengthy and expensive. We may not receive necessary FDA clearances for any of our potential products in a timely manner, or at all. The length of the clinical trial process and the number of patients the FDA will require to be enrolled in the clinical trials in order to establish the safety and efficacy of our products is uncertain. Even if additional pivotal surrogate marker trials of REMUNE are successfully completed, the FDA may not approve REMUNE for commercial sale. We may encounter significant delays or excessive costs in our efforts to secure necessary approvals. Regulatory requirements are evolving and uncertain. Future United States or foreign legislative or 18 administrative acts could also prevent or delay regulatory approval of our products. We may not be able to obtain the necessary approvals for clinical trials, manufacturing or marketing of any of our products under development. Even if commercial regulatory approvals are obtained, they may include significant limitations on the indicated uses for which a product may be marketed. In addition, a marketed product is subject to continual FDA review. Later discovery of previously unknown problems or failure to comply with the applicable regulatory requirements may result in restrictions on the marketing of a product or withdrawal of the product from the market, as well as possible civil or criminal sanctions. Among the other requirements for regulatory approval is the requirement that prospective manufacturers conform to the FDA's Good Manufacturing Practices, GMP, requirements specifically for biological drugs, as well as for other drugs. In complying with the FDA's GMP requirements, manufacturers must continue to expend time, money and effort in production, recordkeeping and quality control to assure that the product meets applicable specifications and other requirements. Failure to comply with the FDA's GMP requirements subjects the manufacturer to possible FDA regulatory action. We or our contract manufacturers, if any, may not be able to maintain compliance with the FDA's GMP requirements on a continuing basis. Failure to maintain compliance could have a material adverse effect on us. The FDA has not designated expanded access protocols for REMUNE as "treatment" protocols. The FDA may not determine that REMUNE meets all of the FDA's criteria for use of an investigational drug for treatment use. Even if REMUNE is allowed for treatment use, third party payers may not provide reimbursement for the costs of treatment with REMUNE. The FDA may not consider REMUNE or any other of the Company's products under development to be an appropriate candidate for accelerated approval, expedited review or fast track designation. To market any drug products outside of the United States, we are also subject to numerous and varying foreign regulatory requirements, implemented by foreign health authorities, governing the design and conduct of human clinical trials and marketing approval. 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 set forth above, and approval by the FDA does not ensure approval by the health authorities of any other country. TECHNOLOGICAL CHANGE AND COMPETITION MAY RENDER OUR POTENTIAL PRODUCTS OBSOLETE The biotechnology industry continues to undergo rapid change and competition is intense and is expected to increase. Competitors may succeed in developing technologies and products that are more effective or affordable than any which are being developed by us or which would render our technology and products obsolete and noncompetitive. Many of our competitors have substantially greater experience, financial and technical resources and production, marketing and development capabilities than us. Accordingly, some of our competitors may succeed in obtaining regulatory approval for products more rapidly or effectively than us. OUR LACK OF COMMERCIAL MANUFACTURING AND MARKETING EXPERIENCE MAY PREVENT US FROM SUCCESSFULLY COMMERCIALIZING PRODUCTS We have not manufactured our product candidates in commercial quantities. We may not successfully make the transition from manufacturing clinical trial quantities to commercial production quantities or be able to arrange for contract manufacturing and this could prevent us from commercializing products. Even if REMUNE is successfully developed and receives FDA approval, we have not demonstrated the capability to manufacture REMUNE in commercial quantities. Except for REMUNE, we have not demonstrated the ability to manufacture our treatments in large-scale clinical or commercial quantities. We have no experience in the sales, marketing and distribution of pharmaceutical products. Thus, our products may not be successfully commercialized even if they are developed and approved for commercialization. The manufacture process of our products involves a number of steps and requires compliance with stringent quality control specifications imposed by us and by the FDA. Moreover, our products can only be manufactured in a facility that has undergone a satisfactory inspection by the FDA. For these reasons, we would not be able quickly to replace our manufacturing capacity if we were unable to use our manufacturing facilities as a result of a fire, natural disaster (including an earthquake), equipment failure or other difficulty, or if such facilities are deemed not in compliance with the FDA's GMP requirements and the non-compliance could not be rapidly rectified. Our inability or reduced capacity to manufacture our products would prevent us from successfully commercializing products. 19 We may enter into arrangements with contract manufacturing companies to expand our own production capacity in order to meet requirements for our products, or to attempt to improve manufacturing efficiency. If we choose to contract for manufacturing services and encounter delays or difficulties in establishing relationships with manufacturers to produce, package and distribute our finished products, clinical trials, market introduction and subsequent sales of the products would be delayed. Further, contract manufacturers must also operate in compliance with the FDA's GMP requirements; failure to do so could result in, among other things, the disruption of product supplies. Our potential dependence upon third parties for the manufacture of our products may adversely affect our profit margins and our ability to develop and deliver products on a timely and competitive basis. ADVERSE DETERMINATIONS CONCERNING PRODUCT PRICING, REIMBURSEMENT AND RELATED MATTERS COULD PREVENT US FROM SUCCESSFULLY COMMERCIALIZING PRODUCTS Our ability to earn sufficient returns on our products will depend in part on the extent to which reimbursement for the costs of the products and related treatments will be available from government health administration authorities, private health coverage insurers, managed care organizations and other organizations. Failure to obtain appropriate reimbursement could prevent us from successfully commercializing products. Third party payors are increasingly challenging the price of medical products and services. If purchasers or users of our products are not able to obtain adequate reimbursement for the cost of using the products, they may forego or reduce their use. Significant uncertainty exists as to the reimbursement status of newly approved health care products, and whether adequate third party coverage will be available. PRODUCT LIABILITY EXPOSURE MAY EXPOSE US TO SIGNIFICANT LIABILITY We face an inherent business risk of exposure to product liability and other claims in the event that the development or use of our technology or prospective products is alleged to have resulted in adverse effects. We may not avoid significant liability exposure. We may not have sufficient insurance coverage and we may not be able to obtain sufficient coverage, at a reasonable cost. An inability to obtain product liability insurance at acceptable cost or to otherwise protect against potential product liability claims could prevent or inhibit the commercialization of products developed by us. A product liability claim could hurt our financial performance. HAZARDOUS MATERIALS/ENVIRONMENTAL MATTERS COULD EXPOSE US TO SIGNIFICANT COSTS Although we do not currently manufacture commercial quantities of our product candidates, we produce limited quantities of these products for our clinical trials. We may be required to incur significant costs to comply with current or future environmental laws and regulations. Our research and development processes involve the controlled storage, use and disposal of hazardous materials, biological hazardous materials and radioactive compounds. We are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these materials and some waste products. Although we believe that our safety procedures for handling and disposing of these materials comply with the standards prescribed by these laws and regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of an accident, we could be held liable for any damages that result, and any liability could exceed our resources. Our operations, business or assets may be materially and adversely affected by current or future environmental laws or regulations. SUBORDINATION OF COMMON STOCK TO PREFERRED STOCK COULD HURT COMMON STOCKHOLDERS Our common stock is expressly subordinate to our Series F Convertible Preferred Stock in the event of our liquidation, dissolution or winding up. If we were to cease operations and liquidate our assets, there may not be any remaining value available for distribution to the holders of common stock after providing for the Series F Convertible Preferred Stock liquidation preference. VOLATILITY OF STOCK PRICE AND ABSENCE OF DIVIDENDS MAY HURT COMMON STOCKHOLDERS The market price of our common stock, like that of the common stock of many other biopharmaceutical companies, has been and is likely to be highly volatile. Factors such as: - the results of preclinical studies and clinical trials by us, our collaborators or our competitors, - other evidence of the safety or efficacy of our products or our competitors, - announcements of technological innovations or new products by us or our competitors, - governmental regulatory actions, 20 - changes or announcements in reimbursement policies, - developments with our collaborators, - developments concerning patent or other proprietary rights of ours or our competitors (including litigation), - concern as to the safety of our products, - period-to-period fluctuations in our operating results, - changes in estimates of our performance by securities analysts, - market conditions for biopharmaceutical stocks in general, and - other factors not within our control could have a significant adverse impact on the market price of our common stock. We have never paid cash dividends on our common stock and do not anticipate paying any cash dividends in the foreseeable future. EFFECT OF CERTAIN ANTI-TAKEOVER PROVISIONS. The Company's Certificate of Incorporation and Bylaws include provisions that could discourage potential takeover attempts and make attempts by stockholders to change management more difficult. The approval of 66 2/3 percent of the Company's voting stock is required to approve certain transactions and to take certain stockholder actions, including the calling of special meetings of stockholders and the amendment of any of the anti-takeover provisions contained in the Company's Certificate of Incorporation. Further, pursuant to the terms of its stockholder rights plan, the Company has distributed a dividend of one right for each outstanding share of common stock. These rights will cause substantial dilution to the ownership of a person or group that attempts to acquire the Company on terms not approved by the Board of Directors and may have the effect of deterring hostile takeover attempts. EXECUTIVE OFFICERS The executive officers of the Company are as follows: DENNIS J. CARLO, PH.D., age 56, a co-founder of the Company, has been President and Chief Executive Officer since September 1994, and Chief Scientific Officer since September 1998. Dr. Carlo was Chief Operating Officer from April 1987 to September 1994 and Executive Vice President from October 1987 to September 1994. Dr. Carlo has been Assistant Corporate Secretary and a Director since 1987. From January 1982 to May 1987, Dr. Carlo was Vice President of Research and Development and Vice President of Therapeutic Manufacturing at Hybritech Incorporated, a biotechnology company that was acquired by Eli Lilly & Company ("Eli Lilly"), a pharmaceutical company, in 1986. From 1971 to 1981, Dr. Carlo held various positions at Merck & Co., Inc., including Director of Development and Basic Cellular Immunology and Director of Bacterial Vaccines and Immunology. Dr. Carlo is also a director of AVANIR Pharmaceuticals and Vyrex Corporation. Dr. Carlo has authored or co-authored over 100 articles and abstracts in the field of immunology. Dr. Carlo received his Ph.D., M.S. and B.S. from Ohio State University. Howard Sampson, age 49, has been Vice President, Finance, Chief Financial Officer and Treasurer of the Company since May 1999, Mr. Sampson was Controller from April 1999 to May 1999. From 1996 to 1999 Mr. Sampson provided executive level financial consulting services for various biomedical companies. From 1991 to 1996 Mr. Sampson was Chief Financial Officer of Genta Inc. Mr. Sampson received his B.S. from San Diego State University and is a C.P.A. in the state of California. ITEM 2. PROPERTIES The Company leases a 50,400 square foot laboratory and headquarters facility located in Carlsbad, California. Under the terms of the lease, which expires on December 31, 2000, and has two five-year options to extend, current monthly rental on the facility is approximately $69,600. 21 The Company also leases a 31,200 square foot facility located adjacent to its headquarters facility in Carlsbad, California. The Company expects this facility to be used for additional laboratory and office space. Under the terms of the lease, which expires in March 2008, monthly rental on the facility is approximately $19,000. The Company has also delivered to the lessor a Letter of Credit for $600,000 as an additional security deposit. The Company leases a 52,500 square foot manufacturing facility located in King of Prussia, Pennsylvania. Under the terms of the lease, which expires on October 31, 2011, and has two five-year options to extend, current monthly rental on the facility is approximately $38,300. ITEM 3. LEGAL PROCEEDINGS Not applicable ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS Not applicable 22 PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS The Company's common stock is traded on the Nasdaq National Market ("NNM") under the symbol "IMNR." The following table sets forth the range of high and low sales prices for the Common stock on the NNM for the periods indicated since January 1, 1998.
1998 HIGH LOW ------ ---- --- January 1 - March 31, 1998 $ 11.44 $ 8.81 April 1 - June 30, 1998 19.69 9.50 July 1 - September 30, 1998 15.00 7.38 October 1 - December 31, 1998 14.69 10.13 1999 HIGH LOW ---- ---- --- January 1 - March 31, 1999 $ 11.38 $ 7.56 April 1 - June 30, 1999 13.25 4.63 July 1 - September 30, 1999 7.13 4.81 October 1 - December 31, 1999 5.75 2.56
As of March 10, 2000, the Company's Common Stock was held by 908 stockholders of record. The Company has never paid cash dividends and does not anticipate paying any cash dividends in the foreseeable future. In October 1999, the Company sold 334,589 shares of newly issued Immune Response common stock to Agouron, priced at a premium to market, for $2 million. In October and November 1999, the Company sold 787,087 shares of newly issued Immune Response common stock to Strong River Investments, Inc., priced at a discount to the market for $3.2 million. In December 1999, the Company issued 250,000 shares of newly issued Immune Response common stock to Connetics Corporation and XOMA, (US) LLC, priced at market for $836,000 in exchange for an exclusive license to intellectual property. The sales and issuances of securities in the transactions described above were deemed to be exempt from registration under the Securities Act of 1933, as amended, by virtue of Section 4(2). The recipients represented their intention to acquire the securities for investment purposes only and not with a view to the distribution thereof. Appropriate legends are affixed to the stock certificates issued in such transactions. All recipients either received adequate information about the Company or had access, through employment or other relationships. ITEM 6. SELECTED FINANCIAL DATA
YEAR ENDED DECEMBER 31, -------------------------------------------------------------------- 1999 1998 1997 1996 1995 -------------------------------------------------------------------- (In thousands, except per share data) STATEMENT OF OPERATIONS DATA: Contract research revenue $14,226 $ 5,488 $ 2,000 $ 1,000 $ 1,561 Licensed research revenue 6,529 12,185 --- 6,000 --- Research and development expenses 31,246 33,240 34,090 27,211 19,489 Net loss (14,968) (18,062) (33,557) (21,026) (19,936) Net loss per share - Basic and diluted (.64) *(.81) (1.53) (1.19) (1.19) Shares used in computing net loss per share 24,851 23,148 21,883 17,658 16,750
*See Note 14 to the Consolidated Financial Statements. 23
DECEMBER 31, -------------------------------------------------------------------- 1999 1998 1997 1996 1995 -------------------------------------------------------------------- (in thousands) BALANCE SHEET DATA: Cash, cash equivalents, marketable securities and short-term investments $23,087 $25,232 $30,439 $47,787 $44,610 Working capital 14,686 22,892 28,939 45,684 43,586 Total assets 39,997 35,626 37,375 54,086 50,429 Stockholders' equity 20,546 22,060 35,102 51,304 48,441
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS OVERVIEW The Immune Response Corporation is a biopharmaceutical company developing immune-based therapies to induce specific immune responses for the treatment of HIV, autoimmune diseases and cancer. In addition, the Company is developing a targeted non-viral delivery technology for gene therapy, which is designed to enable the delivery of genes directly to the liver via intravenous injection. The Company's gene therapy program is focused on diseases of the liver. This discussion contains forward-looking statements concerning the Company's operating results and timing of anticipated expenditures. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include those discussed under "Risk Factors," as well as those discussed elsewhere in this Form 10-K. The following should be read in conjunction with the Consolidated Financial Statements and Notes thereto included elsewhere in this Form 10-K. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. In May 1999, the Company announced the discontinuation of the Phase 3 clinical endpoint trial for the immune-based therapy, REMUNE, based on the recommendation of an independent Data Safety Monitoring Board. As a result of this, in June 1999, the Company implemented a restructuring plan primarily aimed at reducing expenses while focusing the majority of the Company's resources on its late-stage programs of immune-based therapeutics for HIV (REMUNE) and rheumatoid arthritis. The restructuring plan included a reduction in the workforce, in June and again in October, of approximately 30%. The Company took a one-time restructuring charge against earnings of $650,000. During 1999, the Company received from Agouron, under the agreement entered into in 1998, four quarterly payments of $5 million each and a $5 million milestone payment received in February. The quarterly payments represent $12 million to support research and development and $8 million for the purchase of 965,928 shares of the Company's common stock priced at a premium to the market. Under the agreement, the Company agreed to exclusively license REMUNE, its immune-based therapy under development for the treatment of HIV infection, to Agouron. Under the terms of the agreement, the Company will manufacture commercial supplies of REMUNE and Agouron will have exclusive rights to market REMUNE in North America, Europe and certain other countries. The two companies will share profits from the commercialization on a 50/50 basis, if regulatory approvals are received. Agouron will make additional payments upon achievement of certain milestones. In September 1999 and October 1999, the Company received payments of $494,000 each from Schering Corporation under an amendment to extend the research collaboration and option agreement entered into in July 1998 through the remainder of 1999. In March 1999, the Company received a payment of $988,000 to fund research under this agreement. Under this research collaboration and option agreement, the Company agreed to develop gene therapy products for the treatment of hepatitis B and C; and as part of this agreement, Schering Corporation has the option to license the Company's gene delivery system for additional proprietary genes for other diseases for a royalty on future product sales, if any. Through December 1999, the Company had received approximately $4.0 million in payments 24 from Schering Corporation. Schering Corporation's obligation to fund under the research collaboration had expired on December 31, 1999. In September 1999, the Company entered into a $3.0 million equipment line of credit, of which $1.6 million was utilized to fund capital improvements related to increasing the capacity of its manufacturing facility. In November 1999, the Company completed the sale of $3.2 million of its common stock to an institutional investor at a price of $4.00 per share. In December 1999, the Company acquired exclusive technology rights from Connetics Corporation and XOMA, (US) LLC for $4.9 million payable in a combination of cash, notes due through October 31, 2000 and common stock. In January 2000, the Company received a $5.0 million payment from Agouron consisting of a $3.0 million payment for research and development and a $2.0 million payment for the purchase of 266,667 shares of unregistered common stock priced at a premium to the market. This was the final payment in a series of six quarterly payments that the Company expected Agouron to make to fund research and development and to purchase unregistered common stock under the June 1998 agreement. In March 2000, the Company sold 4.65 acres of undeveloped property adjacent to its headquarters facility in Carlsbad, California for approximately $2.0 million. Also in March 2000, the Company sold for cash approximately $2.3 million of equity securities held for sale and will recognize a gain on this transaction in the first quarter 2000. The Company has not been profitable since inception and had an accumulated deficit of $186.5 million as of December 31, 1999. To date, the Company has not recorded any revenues from the sale of products. Revenues recorded through December 31, 1999 were earned in connection with contract research, licensing of technology, milestone achievement payments and investment income. The Company expects its operating losses to continue, as well as to have quarter-to-quarter fluctuations, some of which could be significant, due to research, development and clinical trial activities. There can be no assurance that the Company will be able to generate sufficient product revenue to become profitable at all or on a sustained basis. In December 1999, the Securities and Exchange Commission issued a Staff Accounting Bulletin regarding revenue recognition in financial statements for non-refundable technology access fees in the biotechnology industry, which could impact the Company's financial statement. See Footnote 1 to the Consolidated Financial Statements. RESULTS OF OPERATIONS The Company recorded revenues of $20.8 million in 1999 as compared to $17.7 million in 1998 and $2.0 million in 1997. Revenues for 1999 consist primarily of $15.8 million derived from research and development under collaborative agreements along with a $5.0 million milestone payment under one of the collaborative agreements. Of the $20.8 million of revenues received in 1999, $18.5 million were from Agouron. Revenues for 1998 include $7.7 million derived from research and development under collaborative agreements along with $10.0 million from a license fee under one of the collaborative agreements. Of the $17.7 million of revenues received in 1998, $14.2 million were from Agouron. Revenues for 1997 include $2.0 million derived from research and development under collaborative agreements. None of the revenue received was from the commercial sale of products and the Company does not expect to derive revenue from the sale of products for the foreseeable future. The Company's research and development cost totaled $31.2 million for 1999 as compared to $33.2 million for 1998 and $34.1 million for 1997. The decrease in costs from 1998 to 1999 was due primarily to reduced clinical and regulatory costs associated with the discontinuation of a 2,500 patient Phase 3 clinical trial of REMUNE and costs associated with the autoimmune, gene therapy and cancer programs that was the result of the Company's workforce reduction in June 1999. The decrease in these costs was offset by an increase in cost associated with scale-up of the manufacturing process for REMUNE. The decrease in costs from 1997 to 1998 was due primarily to the initial costs of the 2,500 patient Phase 3 clinical trial of REMUNE being front loaded in 1997, which was due to the aggressive startup of the trial that was started in 1996. Future spending associated with the HIV clinical trials is expected to decrease substantially as future pivotal studies will be conducted by Agouron under the 1998 collaboration agreement. However, spending associated with the Company's scale-up of the manufacturing process for REMUNE 25 and the cost of producing clinical supplies for ongoing and future REMUNE studies could continue to increase in the foreseeable future. Overall future research and development expenditures are expected to decline in the coming year unless additional collaborations are completed. There can be no assurance that any collaborations will be completed, that existing collaborations will not end, or that the Company will be able to obtain other financing needed to continue its research and development efforts. General and administrative expenses totaled $5.2 million for 1999 as compared to $4.2 million for 1998 and $3.9 million for 1997. The increase in spending in 1999 over 1998 was attributable to higher support costs associated with its research and development, increase in public company activities and changes associated with the restructuring. The increase in spending for 1998 over 1997 was attributable to higher support costs associated with its research and development. General and administrative expenses for 2000 are expected to remain somewhat constant to 1999 levels. Restructuring costs of $650,000 for the year ended December 1999 were associated with the Company's restructuring plan implemented in June 1999 and completed in October 1999, which reduced the work force by approximately 30%. Employee severance, health benefits, placement services and other implementation costs were included in the restructuring costs. Other revenue and expense decreased to $1.3 million for 1999 from $1.7 million for 1998 and $2.4 million for 1997. This decrease for 1998 and 1999 was the result of lower investment income on lower average cash and short-term investment balances. For 1999, interest expense associated with equipment financing was netted against income. LIQUIDITY AND CAPITAL RESOURCES Since its inception through December 31, 1999, the Company has financed its activities primarily from public and private sales of equity, funding from collaborations with corporate partners and investment income. At December 31, 1999, the Company had working capital of $14.7 million, including $23.1 million of cash, cash equivalents and marketable securities. This compares with working capital as of December 31, 1998 of $22.9 million, including $25.2 million of cash, cash equivalents and marketable securities. Working capital decreased as a result of the cost of operations, in particular, the cost of the REMUNE HIV clinical trials, clinical trial materials and manufacturing supplies, and the capital improvements incurred to increase the capacity of the manufacturing facility producing REMUNE. This decrease was despite the sale of $3.2 million of common stock to an institutional investor and the financing of $1.6 million of capital equipment. As of December 31, 1999, the Company had $1.4 million remaining under a $3.0 million equipment line of credit that was put in place during 1999. The Company will need to raise additional funds to conduct research and development, preclinical studies and clinical trials necessary to bring its potential products to market and establish manufacturing and marketing capabilities. The Company anticipates that in 2000, the REMUNE clinical trials and manufacturing costs will continue to represent a significant portion of the Company's overall expenditures. The Company also anticipates that costs related to the clinical trials of REMUNE will decrease, as future pivotal studies will be conducted by Agouron. However, spending associated with the Company's scale-up of the manufacturing process for REMUNE and the cost of producing clinical supplies for ongoing and future REMUNE studies could continue to increase in the foreseeable future. Research and development expenses for gene therapy are expected to level off while spending for the rheumatoid arthritis and cancer programs will remain somewhat constant. Overall future research and development expenditures are expected to decline from 1999 levels. Future spending for research and development may increase if additional collaborations are completed, but there can be no assurance that any will be completed. The Company anticipates additional capital improvements of approximately $4.0 million for 2000 related to increasing the capacity of its manufacturing facility, some of which the Company anticipates will be funded with debt financing. Other anticipated costs with respect to REMUNE, including investment in inventory, will depend on many factors, including the results of clinical trials, the continuation of the Company's collaboration with Agouron and other factors which will influence the Company's determination of the appropriate continued investment of the Company's financial resources in this program. The Company's future capital requirements will depend on many factors, including continued scientific progress in its research and development programs, the scope and results of preclinical studies and clinical trials, the time and costs involved in obtaining regulatory approvals, the costs involved in filing, prosecuting and enforcing patent claims, competing technological and market developments, the cost of manufacturing scale-up and inventories, effective commercialization activities and arrangements and other factors not within the Company's control. The Company intends to seek additional funding through additional research and development agreements with suitable corporate collaborators, extensions of existing corporate collaborations, and through public or private financings if 26 available. However, there can be no assurances that such collaboration arrangements or any public or private financings will be available on acceptable terms, if at all. If funds are raised through equity arrangements, further dilution to stockholders may result. If adequate funds are not available, the Company may be required to delay, reduce the scope of, or eliminate one or more of its research or development programs or take other measures to cut costs, which could have a material adverse effect on the Company. The Company estimates that its existing capital resources, along with funding under existing research and development collaborations, available equipment financing and the commitment for equity funding from an existing collaborative partner will be sufficient to fund its current and planned operations into the first half of 2001. There can be no assurances, however, that changes in the Company's research and development plans or other changes affecting the Company's operating expenses may result in the expenditure of such resources before such time. In any event, the Company will need to raise substantial additional capital to fund its operations in future periods. YEAR 2000 The Company has performed a review of its computer applications and equipment related to their continuing functionality for the year 2000 and beyond. The Company does not believe that it has material exposure with respect to the year 2000 issue concerning its computer applications and equipment. The Company communicated with third parties with whom it has a material relationship to assess its risk with respect to year 2000 issues. The Company is not aware, at this time, of any material year 2000 issues with respect to its dealings with such third parties. Year 2000 issues have not disrupted the Company or its operations. Since no significant issues have arisen, the Company does not have a contingency plan to address any material year 2000 issues. 27 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The consolidated financial statements and supplementary data of the Company required by this item are set forth at the pages indicated in Item 14(a)(1). ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE Not applicable PART III ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS The information required by this item (with respect to Directors) is incorporated by reference from the information under the captions "Election of Directors" and "Other Matters" contained in the Company's Proxy Statement to be filed with the Securities and Exchange Commission. ITEM 11. EXECUTIVE COMPENSATION The information required by this item is incorporated by reference from the information under the caption "Compensation of Executive Officers and Directors" contained in the Proxy Statement. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The information required by this item is incorporated by reference from the information under the caption "Stock Ownership of Management and Certain Beneficial Owners" contained in the Proxy Statement. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The information required by this item is incorporated by reference from the information under the caption "Certain Transactions" contained in the Proxy Statement. 28 PART IV ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K (a) (1) Financial Statements The consolidated financial statements required by this item are submitted in a separate section beginning on page F-1 of this report.
CONSOLIDATED FINANCIAL STATEMENTS OF THE IMMUNE RESPONSE CORPORATION Report of Independent Public Accountants F-1 Consolidated Balance Sheets at December 31, 1999 and 1998 F-2 Consolidated Statements of Operations for the three years ended December 31, 1999 F-3 Consolidated Statements of Stockholders' Equity for the three years ended December 31, 1999 F-4 Consolidated Statements of Cash Flows for the three years ended December 31, 1999 F-5 Notes to Consolidated Financial Statements F-6
(2) Financial Statement Schedules Schedules have been omitted because of the absence of conditions under which they are required or because the required information is included in the financial statements or the notes thereto. (3) Exhibits with each management contract or compensatory plan or arrangement required to be filed identified. See paragraph (c) below. (b) Reports on Form 8-K There were no reports on Form 8-K filed by the Company during the fourth quarter of the fiscal year ended December 31, 1999. (c) Exhibits 3(i)(12) Restated Certificate of Incorporation of The Immune Response Corporation, as amended. 3(ii)(6) Restated Bylaws of The Immune Response Corporation. 10.1(7) Amended and Restated 1989 Stock Plan of The Immune Response Corporation. 10.13(1) Assignment, dated May 27, 1988, by Jonas Salk and Dennis J. Carlo, assignors, to the Company. 10.14(1) Assignment, dated May 27, 1988 by Jonas Salk to the Company. 10.17(1) Lease, dated as of May 22, 1989, between the Company and BDN Carlsbad #1 Limited Partnership. 10.28(5)* Form of Indemnification Agreement entered into between the Company and its officers and directors. 10.36(2) First Amendment, dated February 19, 1990, to Lease between BDN Carlsbad #1 Limited Partnership and the Company. 10.37* Amended and Restated 1990 Directors' Stock Option Plan of The Immune Response Corporation. 10.42(3) Second and Third Amendments to the Lease, dated as of May 22, 1989, between the Company and BDN Carlsbad #1 Limited Partnership. 29 10.47(4) Rights Agreement, dated February 26, 1992, between the Company and First Interstate Bank, Ltd., as Rights Agent. 10.53* Form of The Immune Response Corporation Special Nonstatutory Stock Option Agreement. 10.59(10) Unit Purchase Agreement, dated April 15, 1997, between The Immune Response Corporation and Kevin B. Kimberlin, including Common Stock Purchase Warrant, Promissory Note and Stock Pledge Agreement. 10.60(10) Unit Purchase Agreement, dated April 15, 1997, between The Immune Response Corporation and Dennis J. Carlo, Ph.D., including Common Stock Purchase Warrant, Promissory Note and Stock Pledge Agreement. 10.61(10) Amendment No. 1 to Rights Agreement (Exhibit 10.47), dated April 17, 1997, between The Immune Response Corporation and Harris Trust Company of California 10.62(11) Common Stock Purchase Warrant, dated June 26, 1997, between The Immune Response Corporation and Kevin B. Kimberlin. 10.63(11) Common Stock Purchase Warrant, dated June 26, 1997, between The Immune Response Corporation and Dennis J. Carlo, Ph.D. 10.65(15) Letter of Intent dated June 11, 1998 between The Immune Response Corporation and Agouron Pharmaceuticals, Inc. 10.66(15) Common Stock Purchase Agreement dated June 11, 1998 between The Immune Response Corporation and Agouron Pharmaceuticals, Inc. 10.67(13) Securities Purchase Agreement dated as of April 24, 1998 by and among the Company and the Investors. 10.68(14) Registration Rights Agreement dated as of April 24, 1998 by and among the Company and the Investors. 10.69(16) Master Loan and Security Agreement dated as of September 30, 1999 between The Immune Response Corporation, I.R.C. Inc. and Transamerica Business Credit Corporation. 10.70(17) Assignment Agreement dated as of December 8, 1999 by and among the Company and Connetics Corporation (10.1). + 10.71(17) Agreement dated as of December 8, 1999 by and among the Company and XOMA, (US) LLC (10.2). + 10.72 Agreement dated as of October 20, 1999 by and among the Company and Strong River Investments, Inc. 10.73 Lease dated November 1, 1999 by and among the Company and Brandywine Operating Partnership, L.P. 21.1 Subsidiaries of the Registrant. 23.1 Consent of Independent Public Accountants. 24.1 Power of Attorney (see page 32). 27 Financial Data Schedule (1) Incorporated by reference to the exhibits of the same number to the Company's Registration Statement on Form S-1, No. 33-31057. (2) Incorporated by reference to the exhibits of the same number to the Company's Registration Statement on Form S-1, No. 33-34096. (3) Incorporated by reference to the exhibits of the same number to the Company's Report on Form 10-K for the Fiscal Year ended December 31, 1990 (Commission File No. 0-18006). (4) Incorporated by reference to Exhibit 5.1 to the Company's Report on Form 8-K filed March 4, 1992 (Commission File No 0-18006). (5) Incorporated by reference to the exhibits of the same number to the Company's Registration Statement on Form S-1, No. 33-31057. (6) Incorporated by reference to Exhibit 4.2 to the Company's Registration Statement on Form S-8, No. 33-62940. (7) Incorporated by reference to the exhibit of the same number to the Company's Registration Statement on Form S-8, No. 333-81945. 30 (10) Incorporated by reference to the Exhibits of the same number filed with the Company's March 31, 1997 Form 10-Q. (11) Incorporated by reference to the Exhibit of the same number filed with the Company's June 30, 1997 Form 10-Q. (12) Incorporated by reference to the Exhibit of the same number filed with the Company's June 30, 1999 Form 10-Q. (13) Incorporated by reference to Exhibit 10.1 filed with the Company's Form 8-K dated April 24, 1998. (14) Incorporated by reference to Exhibit 10.2 filed with the Company's Form 8-K dated April 24, 1998. (15) Incorporated by reference to the Exhibits of the same number filed with the Company's June 30, 1998 Form 10-Q. (16) Incorporated by reference to the Exhibit of the same number filed with the Company's September 30, 1999 Form 10-Q. (17) Incorporated by reference to Exhibits 10.1 and 10.2 to the Company's Form 8-K dated December 8, 1999. * Indicates management contract or compensatory plan or arrangement. + Confidential treatment for some portions of this exhibit has been requested. 31 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. THE IMMUNE RESPONSE CORPORATION By: /s/ Dennis J. Carlo ------------------------------------- Dennis J. Carlo, President and Chief Executive Officer 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. KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Dennis J. Carlo and Howard Sampson his attorneys-in-fact, each with full power of substitution, for him in any and all capacities, to sign any amendments to this Report and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that said attorneys-in-fact, or their substitute or substitutes, may do or cause to be done by virtue hereof. /s/ James B. Glavin Chairman of the 3/30/00 - ------------------------- Board of Directors ------------ James B. Glavin /s/ Dennis J. Carlo President, 3/30/00 - ------------------------- Chief Executive Officer, ------------ Dennis J. Carlo and Director 3/30/00 /s/ Howard Sampson Vice President, Finance, ------------ - ------------------------- Chief Financial Officer Howard Sampson Secretary and Treasurer /s/ Kevin B. Kimberlin Director 3/30/00 - ------------------------- ------------ Kevin B. Kimberlin /s/ Melvin Perelman Director 3/30/00 - ------------------------- ------------ Melvin Perelman /s/ William M. Sullivan Director 3/30/00 - ------------------------- ------------ William M. Sullivan /s/ Philip M. Young Director 3/30/00 - ------------------------- ------------ Philip M. Young 32 REPORT OF INDEPENDENT PUBLIC ACCOUNTANTS The Immune Response Corporation: We have audited the accompanying consolidated balance sheets of The Immune Response Corporation (a Delaware corporation) and subsidiaries as of December 31, 1999, and 1998, and the related consolidated statements of operations, stockholders' equity, and cash flows for each of the three years in the period ended December 31, 1999. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of The Immune Response Corporation and subsidiaries at December 31, 1999, and 1998, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 1999, in conformity with accounting principles generally accepted in the United States. ARTHUR ANDERSEN LLP San Diego, California March 3, 2000 F1 THE IMMUNE RESPONSE CORPORATION CONSOLIDATED BALANCE SHEETS (in thousands, except share data)
December 31, ---------------------------------------------- 1999 1998 ------------------- ------------------- ASSETS Current assets: Cash and cash equivalents $ 4,183 $ 1,889 Marketable securities - available-for-sale 18,904 23,343 Other current assets 202 1,613 ------------------- ------------------- Total current assets 23,289 26,845 Property and equipment, net 10,760 7,825 Licensed technology 4,945 --- Deposits and other assets 1,003 956 ------------------- ------------------- $ 39,997 $ 35,626 =================== =================== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 1,536 $ 2,755 Accrued expenses 3,024 1,198 License contract payable 3,609 --- Current portion of equipment notes payable 287 --- Deferred rent obligation 147 --- ------------------- ------------------- Total current liabilities 8,603 3,953 ------------------- ------------------- Equipment notes payable 1,221 --- ------------------- ------------------- Deferred rent obligation --- 266 ------------------- ------------------- Commitments (Note 3) Redeemable convertible preferred stock 9,627 9,347 ------------------- ------------------- Stockholders' equity: Preferred stock, 5,000,000 shares authorized; none issued --- --- Common stock, $.0025 par value, 65,000,000 shares authorized, 26,370,135 and 23,795,292 shares issued and outstanding at December 31, 1999 and 1998, respectively 66 59 Warrants 2,144 2,144 Additional paid-in capital 203,131 191,317 Accumulated other comprehensive income 1,735 102 Accumulated deficit (186,530) (171,562) ------------------- ------------------- Total stockholders' equity 20,546 22,060 ------------------- ------------------- $ 39,997 $ 35,626 =================== ===================
See accompanying notes. F2 THE IMMUNE RESPONSE CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data)
Year ended December 31, -------------------------------------------------------------------- 1999 1998 1997 Revenues: Contract research revenue $ 14,226 $ 5,488 $ 2,000 Licensed research revenue 6,529 12,185 --- ------------------ ------------------ ------------------ 20,755 17,673 2,000 ------------------ ------------------ ------------------ Expenses: Research and development 31,246 33,240 34,090 General and administrative 5,154 4,163 3,904 Restructuring costs 650 --- --- ------------------ ------------------ ------------------ 37,050 37,403 37,994 ------------------ ------------------ ------------------ Other revenue and expense: Investment income 1,327 1,668 2,437 ------------------ ------------------ ------------------ Net loss (14,968) (18,062) (33,557) Accretion of preferred stock (280) (187) --- Preferred dividends (750) (518) --- ------------------ ------------------ ------------------ Net loss applicable to common stockholders $ (15,998) $ (18,767) $ (33,557) ================== ================== ================== Net loss per share - basic and diluted $ (0.64) $ (0.81) $ (1.53) ================== ================== ================== Weighted average number of shares outstanding 24,851 23,148 21,883 ================== ================== ==================
See accompanying notes. F3 THE IMMUNE RESPONSE CORPORATION CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (in thousands)
Common Stock Additional ------------------------------ Paid-in Shares Amount Warrants Capital ------------- ------------- -------------- --------------- Balance at December 31, 1996 20,230 $ 51 $ --- $ 171,056 Issuance of common stock and warrants in private transaction, net of issuance costs of $360,000 2,051 5 2,144 13,491 Issuance of common stock from exercise of options 534 1 --- 1,827 Change in unrealized gain (loss) on marketable securities --- --- --- --- Net loss --- --- --- --- ------------- ------------- ------------ ---------------- Balance at December 31, 1997 22,815 57 2,144 186,374 Issuance of common stock in private transaction 245 1 --- 2,814 Issuance of common stock as dividend on convertible preferred stock 22 --- --- --- Accrual for preferred stock dividend --- --- --- (263) Accretion of convertible preferred stock costs --- --- --- (187) Issuance of common stock from exercise of options 713 1 --- 2,579 Change in unrealized gain (loss) on marketable securities --- --- --- --- Net loss --- --- --- --- ------------- ------------- ------------ ---------------- Balance at December 31, 1998 23,795 59 2,144 191,317 Issuance of common stock in private transactions, net 1,753 5 --- 9,572 of issuance costs of $20,000 Issuance of common stock for licensed technology 250 1 --- 836 Issuance of common stock as dividend on convertible preferred stock 85 --- --- --- Accrual for preferred stock dividend --- --- --- (163) Accretion of convertible preferred stock costs --- --- --- (280) Issuance of common stock from exercise of options 487 1 --- 1,849 Change in unrealized gain (loss) on marketable securities --- --- --- --- Net loss --- --- --- --- ------------- ------------- ------------ ---------------- Balance at December 31, 1999 26,370 $ 66 $ 2,144 $ 203,131 ============= ============= ============ ================
Accumulated Other Total Comprehensive Accumulated Stockholders' Comprehensive Income (Loss) Deficit Equity Income (Loss) ---------------- --------------- ------------- --------------- Balance at December 31, 1996 $ 140 $ (119,943) $ 51,304 Issuance of common stock and warrants in private transaction, net of issuance costs of $360,000 --- --- 15,640 Issuance of common stock from exercise of options --- --- 1,828 Change in unrealized gain (loss) on marketable securities (113) --- (113) $ (113) Net loss --- (33,557) (33,557) (33,557) ------------- -------------- --------------- ---------------- Balance at December 31, 1997 27 (153,500) 35,102 $ (33,670) ================ Issuance of common stock in private transaction --- --- 2,815 Issuance of common stock as dividend on convertible preferred stock --- --- --- Accrual for preferred stock dividend --- --- (263) Accretion of convertible preferred stock costs --- --- (187) Issuance of common stock from exercise of options --- --- 2,580 Change in unrealized gain (loss) on marketable securities 75 --- 75 $ 75 Net loss --- (18,062) (18,062) (18,062) ------------- -------------- --------------- ---------------- Balance at December 31, 1998 102 (171,562) 22,060 $ (17,987) ================ Issuance of common stock in private transactions, net --- --- 9,577 of issuance costs of $20,000 Issuance of common stock for licensed technology --- --- 837 Issuance of common stock as dividend on convertible preferred stock --- --- --- Accrual for preferred stock dividend --- --- (163) Accretion of convertible preferred stock costs --- --- (280) Issuance of common stock from exercise of options --- --- 1,850 Change in unrealized gain (loss) on marketable securities 1,633 --- 1,633 $ 1,633 Net loss --- (14,968) (14,968) (14,968) ------------- -------------- --------------- ---------------- Balance at December 31, 1999 $ 1,735 $ (186,530) $ 20,546 $ (13,335) ============= ============== =============== ================
See accompanying notes F4 THE IMMUNE RESPONSE CORPORATION CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands)
Year ended December 31, ----------------------------------------------- 1999 1998 1997 ------------ ------------ ------------- Operating activities: Net loss $ (14,968) $ (18,062) $ (33,557) Adjustments to reconcile net loss to net cash used by operating activities: Depreciation and amortization 1,508 1,486 1,266 Deferred rent expense (119) (89) (59) Changes in operating assets and liabilities: Other current assets 1,411 (840) (93) Accounts payable (1,219) 1,399 (515) Accrued expenses 1,663 374 64 ------------- ------------ ------------- Net cash used in operating activities (11,724) (15,732) (32,894) ------------- ------------ ------------- Investing activities: Sale of marketable securities, net 6,072 2,299 18,322 Purchase of property and equipment (4,443) (3,501) (2,526) Sale of land --- --- 1,020 Purchase of licensed technology (500) --- --- Other assets (47) (603) (304) ------------- ------------ ------------- Net cash provided by (used in) investing activities 1,082 (1,805) 16,512 ------------- ------------ ------------- Financing activities: Proceeds from equipment notes payable 1,621 --- --- Principal payments under equipment notes payable (112) --- --- Proceeds from other sales of common stock 9,577 2,815 --- Net proceeds from sale of common stock and warrants through private offering --- --- 15,640 Net proceeds from the sale of convertible preferred stock --- 9,160 --- Net proceeds from exercise of stock options 1,850 2,579 1,829 ------------- ------------ ------------- Net cash provided by financing activities 12,936 14,554 17,469 ------------- ------------ ------------- Net increase (decrease) in cash and cash equivalents 2,294 (2,983) 1,087 Cash and cash equivalents at beginning of year 1,889 4,872 3,785 ------------- ------------ ------------- Cash and cash equivalents at end of year $ 4,183 $ 1,889 $ 4,872 ============= ============ ============= Supplemental disclosure of cash flow information: Interest paid $ 45 $ --- $ --- ============= ============ ============= Supplemental disclosure of noncash investing and financing activities: Issuance of common stock and notes for licensed technology $ 4,445 $ --- $ --- ============= ============ ============= Accretion of convertible preferred stock $ 280 $ 187 $ --- ============= ============ ============= Payment of dividend on convertible preferred stock with common stock $ 776 $ 329 $ --- ============= ============ ============= Declared dividend on convertible preferred stock $ 163 $ 189 $ --- ============= ============ =============
See accompanying notes F5 THE IMMUNE RESPONSE CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 1999 1. ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES ORGANIZATION The Immune Response Corporation (the "Company"), a Delaware corporation, is a biopharmaceutical company developing immune-based therapies to induce immune responses for the treatment of HIV, autoimmune diseases and cancer. In addition, the Company is developing a targeted non-viral delivery technology for gene therapy, which is designed to enable the delivery of genes directly to the liver via intravenous injection. The Company's gene therapy program is focused on diseases of the liver. The Company's products are in various stages of development. Prior to generating product revenues, the Company must complete the development of its products, including several years of human clinical testing, and receive regulatory approvals prior to selling these products in the human health care market. The Company's products may not be successfully developed, regulatory approvals may not be granted, or patient and physician acceptance of any of these products may not be achieved. The Company faces additional risks associated with biopharmaceutical companies whose products are in various stages of development. These risks include, among others, the Company's need for additional financing to complete its research and development programs and commercialize its technologies. Financing may not be available to the Company when required or 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 pharmaceutical and biotechnology firms, including the Company, are uncertain and involve complex legal and factual questions for which important legal principles are largely unresolved. PRINCIPLES OF CONSOLIDATION The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated. SEGMENT REPORTING The Company has determined that it operates in one business segment dedicated to pharmaceutical research. USE OF ESTIMATES The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Certain prior year amounts have been reclassified to conform with the current year presentation. CONCENTRATION OF CREDIT RISK The Company invests its excess cash in U.S. government securities and money market accounts. The Company has established guidelines relative to diversification and maturities that maintain safety and liquidity. These guidelines are periodically reviewed and modified to take advantage of trends in yields and interest rates. CONCENTRATION OF RISK Substantially all of the Company's revenues are derived from collaborative arrangements with Agouron Pharmaceuticals, Inc., a Warner-Lambert Company ("Agouron") and Schering Corporation ("Schering"). As of December 31, 1999, Schering's obligation to fund the research program under the collaboration had expired. See Notes 9 and 10. CASH AND CASH EQUIVALENTS Cash and cash equivalents consist of cash, money market funds, time deposits and treasury securities with original maturities at the date of acquisition of less than three months. F6 THE IMMUNE RESPONSE CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1999 MARKETABLE SECURITIES - AVAILABLE-FOR-SALE The Company classifies all of its marketable securities as available-for-sale and reports them at fair market value. The unrealized gains or losses are reported as a component of stockholders' equity - Accumulated other comprehensive income. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization is included in interest income. Realized gains and losses are also included in interest income. The cost of securities sold is based on the specific identification method. PROPERTY AND EQUIPMENT Property and equipment are recorded at cost and are depreciated or amortized over their estimated useful lives using the straight-line method. Leasehold improvements are amortized over the shorter of their estimated useful lives or the remaining term of the related lease. Other property and equipment have useful lives ranging from three to seven years. LICENSED TECHNOLOGY Intangible assets are recorded at cost and amortized over their estimated useful lives. In December 1999, the Company acquired licenses to certain patent technology. These licenses will be amortized over seven years beginning in the year 2000. IMPAIRMENT OF LONG-LIVED ASSETS The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. Impairment is measured at fair value. Fair value is determined by an evaluation of available price information at which assets could be bought or sold including quoted market prices, if available, or the present value of the estimated future discounted cash flows based on reasonable assumptions. STOCK-BASED COMPENSATION The Company accounts for stock-based compensation in accordance with Accounting Principles Board ("APB") 25, "Accounting for Stock Issued to Employees". In 1996, the Company adopted the disclosure requirements of Statement of Financial Accounting Standards ("FAS") FAS No. 123, "Accounting for Stock-Based Compensation". Under APB 25, compensation expense relating to employee stock options is determined based on the excess of the market price of the Company's stock over the exercise price on the date of grant and does not require the recognition of compensation expense for stock issued under plans defined as noncompensatory. Adoption of FAS No. 123 requires recognition of compensation expense for virtually all options based on their computed "fair value" on the date of the grant. COMPREHENSIVE INCOME The Company accounts for comprehensive income in accordance with FAS No. 130, "Reporting Comprehensive Income." The Company reports the accumulated balance of other comprehensive income or loss separately in the equity section of the consolidated balance sheets. Prior year financial statements have been reclassified to conform to the revised presentation. The only component of comprehensive income is unrealized gain or loss on marketable securities. REVENUES UNDER COLLABORATIVE AGREEMENTS The Company earns revenue from licensing its proprietary technology and performing services under research and development contracts. Initial fees under license and option agreements are recognized upon contract signing if the fees are nonrefundable and there are no significant performance obligations remaining. Revenues from milestones are recognized as the milestones are achieved. Revenue under research and development contracts is recognized as the services are performed. Advance payments received in excess of amounts earned are classified as deferred revenue. RESEARCH AND DEVELOPMENT COSTS All research and development costs are charged to expense as incurred. F7 THE IMMUNE RESPONSE CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1999 INCOME TAXES All income tax amounts have been computed in accordance with FAS No. 109, "Accounting for Income Taxes." Under this statement, the liability method is used to account for deferred income taxes. Under this method, deferred tax assets and liabilities are determined based on temporary differences between the financial reporting and tax base of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences reverse. NET LOSS PER SHARE Basic and diluted net loss per share is computed using the weighted average number of common shares outstanding during the period. Potentially dilutive securities are excluded from the diluted net loss per share calculation, as the effect would be antidilutive. RECENT ACCOUNTING PRONOUNCEMENTS In December 1999, the Securities and Exchange Commission issued Staff Accounting Bulletin ("SAB") No. 101 - "Revenue Recognition in Financial Statements". The bulletin draws on existing accounting rules and provides specific guidance on how those accounting rules should be applied and specifically addresses revenue recognition for non-refundable technology access fees in the biotechnology industry. SAB No. 101 is effective for fiscal years beginning after December 15, 1999. The Company has not completed its evaluation of the impact of SAB No. 101 on its financial statements, however, the impact is expected to be in a pre-tax range of approximately $10 million to $15 million charged to the Company's results of operations in the first quarter of fiscal year 2000. 2. MARKETABLE SECURITIES Marketable securities consist of treasury securities with maturities of more than three months and common stock acquired through former research collaborations. The following table summarizes available-for-sale securities:
AVAILABLE-FOR-SALE SECURITIES ------------------------------------------------------------- GROSS GROSS (IN THOUSANDS) UNREALIZED UNREALIZED ESTIMATED COST GAINS LOSSES FAIR VALUE ------------- --------------- --------------- --------------- DECEMBER 31, 1999 U.S. Government Securities $ 17,169 $ --- $ 118 $ 17,051 Equity Securities --- 1,853 --- 1,853 ------------ -------------- -------------- ----------- $ 17,169 $ 1,853 $ 118 $ 18,904 ============ ============== =========== =========== DECEMBER 31, 1998 U.S. Government Securities $ 23,241 $ 110 $ 8 $ 23,343 ============ ============== =========== ===========
The net realized gains on sales of available-for-sale securities, which are included in investment income in the accompanying Statement of Operations, totaled $31,000, $38,000 and $16,000 for the years ended December 31, 1999, 1998 and 1997, respectively. The amortized cost and estimated fair value of available-for-sale securities at December 31, 1999, by contractual maturity, are shown below:
ESTIMATED COST FAIR VALUE ------------ ------------ Due in one year or less $ 14,171 $ 14,087 Due after one year through two years 2,998 2,964 ------------ ------------ Totals $ 17,169 $ 17,051 ============ ============
F8 THE IMMUNE RESPONSE CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1999 3. BALANCE SHEET INFORMATION Property and equipment consists of the following:
DECEMBER 31, ------------------ --------------- 1999 1998 ------------------ --------------- (IN THOUSANDS) Furniture and fixtures $ 1,547 $ 1,351 Equipment 2,816 1,486 Leasehold improvements 13,254 10,337 Land - held for sale 1,339 1,339 ----------- ----------- 18,956 14,513 Less accumulated depreciation and amortization (8,196) (6,688) ----------- ----------- $ 10,760 $ 7,825 =========== ===========
4. EQUIPMENT NOTES PAYABLE In September 1999, the Company obtained an equipment financing line of $3.0 million, of which it drew down approximately $1.6 million by December 31, 1999. The loan, which is secured by the equipment, bears interest at 11.1% and is to be repaid monthly over a four-year term. Principal payments due on equipment notes payable at December 31 are as follows:
YEARS ENDED DECEMBER 31 ----------------------- (IN THOUSANDS) 2000 $ 287 2001 348 2002 389 2003 484 --------- 1,508 Less current portion (287) --------- $ 1,221 =========
The carrying value of the Company's obligations under equipment notes payable approximates its fair value, and the implicit interest rate approximates the Company's borrowing rate. 5. LICENSED TECHNOLOGY In December 1999, the Company entered into a technology licensing agreement with Connetics Corporation ("Connetics") and XOMA, (US) LLC ("XOMA"). The agreement assigns exclusive rights to T cell receptor ("TCR") intellectual property to the Company in exchange for approximately $4.9 million in cash, common stock and short-term license contract payable. The agreement also requires the Company to make royalty payments on future sales of products, if any, related to the TCR intellectual property to Connetics, XOMA and Dr. Arthur Vandenbark, one of the inventors of the assigned technology. The Company owns additional TCR-related intellectual property and intends to carry forward development of pharmaceutical products for the treatment of rheumatoid arthritis and other autoimmune diseases using the technology. The Company capitalized the purchase cost to licensed technology. The license contract payable requires four quarterly payments of $250,000 beginning in January 2000. F9 THE IMMUNE RESPONSE CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1999 6. COMMITMENTS The Company leases its offices, research facilities, manufacturing facility, and certain office and laboratory equipment under operating lease agreements. The equipment lease agreements require monthly payments through June 2002. The office and research facility lease agreement, which commenced in January 1991, is for a term of ten years, with two five-year options to extend. In connection with this lease, the Company received certain deferred payment terms and the minimum annual rent is subject to certain annual increases. Rent is being expensed on a straight-line basis over the term of the lease. Deferred rent reflected in the accompanying balance sheet represents the difference between rent expense accrued and amounts actually paid under the terms of the lease. The Company leases a manufacturing facility in King of Prussia, Pennsylvania. The lease, which was renegotiated in November 1999, is for a term of twelve years, with two five-year options to extend. At December 31, 1999, future minimum rental payments due under the Company's noncancelable operating leases are as follows:
YEAR ENDING DECEMBER 31, ------------------------------------- (IN THOUSANDS) 2000 $ 3,305 2001 1,909 2002 939 2003 762 2004 520 Thereafter 4,000 ------------- $ 11,435 =============
Total rent expense for the years ended December 31, 1999, 1998, and 1997 was $3.0 million, $2.4 million, and $2.4 million, respectively. 7. RESTRUCTURING COSTS In May 1999, the Company announced the discontinuation of the Phase III clinical endpoint trial for the immune-based therapy, Remune, based on the recommendation of an independent Data Safety Monitoring Board. As a result of this, in June 1999, the Company implemented a restructuring plan primarily aimed at reducing expenses while focusing the majority of the Company's resources on its late-stage programs of immune-based therapies. The primary cost savings were achieved by a reduction in force affecting approximately 47 employees of a total 158-person workforce begun in June 1999 and completed in October 1999. All employees were notified of such termination and their estimated severance benefits in advance of the Company recording the charge. The cost of the restructuring resulted in an all-cash, one-time charge against earnings of $650,000 primarily for severance costs for salaries, benefits continuation, consultants and outplacement services. As of December 31, 1999 approximately $100,000 was still accrued. 8. STOCKHOLDERS' EQUITY STOCK TRANSACTIONS During April 1998, the Company sold 200 shares of its Series F Convertible Preferred Stock ("Series F Stock") in return for gross proceeds of $10 million. In February 1999, the initial conversion price of the Series F stock of $14.07 per share of common stock was adjusted downward to $9.77 per share of common stock. In August 1999, the conversion price was adjusted downward to $5.87 per share of common stock. In November 1999, the conversion price was adjusted downward to $4.17 per share of common stock. The conversion price may be further adjusted downward at the end of each subsequent three-month period if the Company's common stock does not trade at prices higher than the conversion price over a period of time during the applicable three-month period. The Series F10 THE IMMUNE RESPONSE CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1999 F Stock bears a dividend of 7.5% per annum. In general, the dividend is payable in shares of common stock or cash at the Company's option. For the years ended December 31, 1999 and 1998, 84,668 and 22,234 shares of the Company's common stock were issued as dividends to the Series F shareholders, respectively. The Company has filed a registration statement with the Securities and Exchange Commission covering the resale of the common stock issuable upon conversion of the Series F Stock. During 1997, the Company completed a $16.0 million private placement of units consisting of common stock and warrants to purchase common stock of the Company. These units were purchased at a price of $7.80 per unit by a director of the Company and the Company's President and Chief Executive Officer. The units sold in the private placement consisted of 2,051,281 shares of common stock plus warrants exercisable for 2,051,281 shares of common stock. The warrants, with an exercise price of $14.00 per share, are callable by the Company if the Company's common stock trades at $28.00 per share or greater for 45 consecutive days. The warrants expire on April 17, 2001. The shares and warrants are unregistered. STOCK OPTIONS The Company has established various stock option plans to grant options to purchase common stock to employees and non-employee directors of the Company and certain other individuals. The plans authorize the Company to issue or grant qualified and non-qualified options to purchase up to 8,650,000 shares of its common stock. Under the terms of the 1989 Stock Plan, options may be granted at not less than 100% and 85% of fair market value as of the date of grant for qualified and non-qualified options, respectively. To date, all options have been issued at 100% of fair market value. These options primarily become exercisable over a four-year period from the date of grant. The 1990 Directors' Stock Option Plan provides for the Company to issue or grant non-qualified options to purchase up to 650,000 common shares to its non-employee directors. Under the terms of the plan, options will be granted at the fair market value as of the date of grant. These options become exercisable in four equal annual installments on each of the first four anniversaries of the date of grant. Additionally, the 1990 Directors' Stock Option Plan provides that upon each date of the Company's Annual Meeting of the Stockholders, non-employee directors are eligible to receive a grant of 6,250 shares at the fair market value on date of grant with a one-year vesting schedule. Activity with respect to the various stock plans is summarized as follows:
STOCK WEIGHTED OPTIONS AVERAGE (IN THOUSANDS) OUTSTANDING PRICE --------------- ------------ Balance at December 31, 1996 4,050 $ 4.71 Granted 578 8.34 Exercised (534) 3.42 Cancelled (91) 6.75 ----------- Balance at December 31, 1997 4,003 5.36 Granted 705 10.38 Exercised (713) 3.62 Cancelled (122) 8.94 ----------- Balance at December 31, 1998 3,873 6.48 Granted 1,749 6.88 Exercised (487) 3.80 Cancelled (620) 8.82 =========== Balance at December 31, 1999 4,515 $ 6.60 ===========
F11 THE IMMUNE RESPONSE CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1999 Following is a summary of the options outstanding as of December 31, 1999:
WEIGHTED (IN THOUSANDS) WEIGHTED WEIGHTED AVERAGE AVERAGE AVERAGE EXERCISE PRICE RANGE OF OPTIONS REMAINING EXERCISE OPTIONS OF OPTIONS EXERCISE PRICES OUTSTANDING LIFE IN YEARS PRICE EXERCISABLE EXERCISABLE ------------------------- ------------- --------------- ---------- -------------- ----------------- $ 2.88 - $ 3.25 1,249 3.37 $ 3.23 1,234 $ 3.23 $ 3.50 - $ 6.38 1,138 8.91 4.90 277 5.06 $ 6.56 - $ 8.88 1,184 7.20 7.82 870 7.59 $ 9.13 - $ 18.25 944 7.45 11.60 545 12.51 ----------- ----------- 4,515 6.63 $ 6.60 2,926 $ 6.43 =========== ===========
At December 31, 1999, 10,905,000 shares of common stock were reserved for the exercise of stock options and warrants, future dividends on the Series F Stock, and future purchase of stock by Agouron. See Note 9. The Company has adopted the disclosure-only provisions of FAS No. 123. Accordingly, no compensation cost has been recognized for the stock option plans. Had compensation cost for the Company's stock option plans been determined based on the fair value at the grant date for awards in 1999, 1998 and 1997, consistent with the provisions of FAS No. 123, the Company's net loss and loss per share would have been increased to the pro forma amounts indicated below:
1999 1998 1997 ---- ---- ---- (IN THOUSANDS, EXCEPT PER SHARE DATA) Net loss - as reported $ 14,968 $ 18,062 $ 33,557 Net loss - pro forma $ 19,645 $ 22,397 $ 36,886 Net loss per share - as reported $ .64 $ .81 $ 1.53 Net loss per share - pro forma $ .83 $ 1.00 $ 1.69
The fair value of each option grant was estimated on the date of grant using the Black Scholes option-pricing model with the following weighted average assumptions used for grants in 1999, 1998 and 1997: risk-free interest rates of 6.621%, 4.733% and 5.72%, respectively; expected option lives of 5 years, 6 years and 5 years, respectively; a dividend rate of zero. The volatility factor assumptions of the expected market price of the Company's common stock were 91%, 84% and 83% for 1999, 1998 and 1997, respectively. Because FAS No. 123 has not been applied to options granted prior to January 1, 1995, the resulting pro forma compensation cost may not be representative of that to be expected in future years. The weighted average fair value of options granted during 1999, 1998 and 1997 was $6.88, $10.38 and $8.34, respectively. STOCKHOLDER RIGHTS PLAN The Company has a Stockholder Rights Plan that provides for the distribution of a preferred stock purchase right (a "Right") as a dividend for each share of the Company's common stock of record held at the close of business on March 12, 1992, as well as all future stock issuances. Under certain conditions involving an acquisition by any person or group of 15% or more of the common stock, the Rights permit the holders (other than the 15% holder) to purchase the Company's common stock at a 50% discount upon payment of an exercise price of $150 per Right. In addition, in the event of certain business combinations, the Rights permit the purchase of the common stock of an acquiror at a 50% discount. Under certain conditions, the Rights may be redeemed by the Board of Directors in F12 THE IMMUNE RESPONSE CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1999 whole, but not in part, at a price of $.01 per Right. The Rights have no voting privileges and are attached to and automatically trade with the Company's common stock. The Rights expire February 26, 2002. 9. REMUNE-TM- COLLABORATION WITH AGOURON PHARMACEUTICALS, INC. During June 1998, the Company and Agouron entered into a binding agreement under which the Company agreed to exclusively license to Agouron, REMUNE-TM-, its immune-based therapy under development for the treatment of HIV infection. Under the terms of the agreement, the Company will manufacture commercial supplies of REMUNE; and Agouron will have exclusive rights to market REMUNE in North America, Europe, Japan and certain other countries, if regulatory approvals are received. As a result of this agreement, the Company may receive as much as $77 million, including license and milestone payments of $45 million, payments to support research and development of $18 million and $14 million for the purchase of the Company's common stock, priced at a premium to the market, subject to certain rights of termination by Agouron. In addition, the two companies will share all profits from the commercialization of REMUNE on a 50/50 basis, if REMUNE is successfully developed and receives the necessary regulatory approvals. As of December 31, 1999, the Company had received a total of $42 million from Agouron under the agreement. Agouron will make additional payments upon achievement of certain milestones. Amounts received in 1999 were comprised of the four quarterly payments of $5 million each and a $5 million milestone payment received in February. The quarterly payments represent $12 million to support research and development and $8 million for the purchase of 965,928 shares of the Company's common stock priced at a premium to the market. Amounts received in 1998 were comprised of the initial $10 million license fee, a $2 million stock purchase and the first quarterly payment for $5 million to support research and development and to purchase stock. Agouron purchased 245,014 shares of the Company's common stock priced at a premium to the market in 1998. Subsequent to year-end, the Company received a $5 million payment from Agouron consisting of a $3 million payment for research and development and a $2 million payment for the purchase of 266,667 shares of unregistered common stock priced at a premium to the market. This was the final payment in a series of six quarterly payments that the Company expected Agouron to make to fund research and development and to purchase unregistered common stock under the June 1998 agreement. 10. GENE THERAPY LICENSE AGREEMENT In July 1998, the Company entered into a research collaboration and option agreement with Schering to develop gene therapy products for the treatment of hepatitis B and C and other diseases. In September 1999 and October 1999, the Company received payments for $494,000 each under an amendment to extend the agreement through the remainder of 1999. In March 1999, the Company received a payment of $988,000 to fund research under this agreement. During 1998, the Company received approximately $2 million under the agreement. As part of the agreement, Schering has the option to license the Company's gene delivery system for additional proprietary Schering genes for other diseases for a royalty on future product sales, if any. As of December 31, 1999, Schering's obligation to fund the research program under the collaboration had expired. 11. SECTION 401(k) PROFIT SHARING PLAN The Company has a defined contribution plan, The Immune Response Corporation 401(k) Savings and Profit Sharing Plan, which covers substantially all employees of the Company. This plan allows each eligible employee to voluntarily make pre-tax deferred salary contributions. The Company may make matching contributions in amounts as determined by the board of directors. The Company made matching contributions of approximately $113,000, $103,000, and $101,000, for the years ended December 31,1999, 1998, and 1997, respectively. F13 THE IMMUNE RESPONSE CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1999 12. INCOME TAXES At December 31, 1999, the Company had federal and California tax net operating loss carryforwards of approximately $161.4 million and $3.5 million, respectively. The difference between the federal and California tax loss carryforwards is primarily attributable to capitalized research and development expenses for California and the 50% limitation of California loss carryforwards. The federal tax loss carryforwards will begin expiring in 2002, unless previously utilized, while the California tax loss carryforwards began to expire in 1995. The Company also has federal and California research and development tax credit carryforwards of $8.6 million and $3.8 million, respectively. The federal research and development credits begin expiring in 2002. Pursuant to Internal Revenue Code Sections 382 and 383, annual use of the Company's net operating loss and credit carryforwards will be limited because of a cumulative change in ownership of more than 50% which occurred during 1992. However, the Company does not believe such change will have a material impact upon the utilization of these carryforwards. Included in the federal loss carryforwards are approximately $4.4 million of acquired net operating loss carryforwards that can only be used to the extent of the separate taxable income of the acquired company. The components of the Company's deferred tax assets as of December 31, 1999, and 1998 are as follows:
DECEMBER 31, -------------------------------- (IN THOUSANDS) 1999 1998 -------------- ------------- Net operating loss carryforwards $ 55,078 $ 50,388 Unused research and development credits 12,387 11,900 Capitalized research and development 7,298 6,321 Other 1,837 1,591 -------------- ------------- 76,600 70,200 Valuation allowance (76,600) (70,200) -------------- ------------- $ --- $ --- ============== =============
Approximately $7.2 million of the valuation allowance at December 31, 1999 relates to benefits of stock options which, when recognized, will be allocated directly to stockholders' equity. 13. SUBSEQUENT EVENTS In January 2000, the Company received a $5 million payment from Agouron consisting of a $3 million payment for research and development and a $2 million payment for the purchase of 266,667 shares of unregistered common stock priced at a premium to the market. This was the final payment in a series of six quarterly payments that the Company expected Agouron to make to fund research and development and to purchase unregistered common stock under the June 1998 agreement. On March 3, 2000, the Company completed a sale of 4.65 acres of undeveloped property adjacent to its facility in Carlsbad, California for approximately $2 million net proceeds. F14 THE IMMUNE RESPONSE CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) DECEMBER 31, 1999 14. QUARTERLY RESULTS (UNAUDITED) The following unaudited quarterly financial information includes, in management's opinion, all normal and recurring adjustments necessary to fairly state the Company's consolidated results of operations and related information for the periods presented. Net loss per share has been computed using the weighted average shares outstanding during each quarter. Certain net loss per share amounts have been revised from amounts previously reported to reflect the exclusion of dividends and accretion on preferred stock.
1ST 2ND 3RD 4TH QUARTER QUARTER QUARTER QUARTER --------------- --------------- --------------- ---------------- (IN THOUSANDS, EXCEPT PER SHARE DATA) 1999 Contract research revenue $ 3,744 $ $3,494 $ 3,494 $ 3,494 Licensed research revenue 5,462 400 333 333 Operating expenses 10,913 10,289 8,980 6,248 --------------- --------------- --------------- ---------------- Loss from operations before restructuring costs (1,707) (6,395) (5,153) (2,421) Restructuring costs - 650 - - Other income 380 353 304 321 --------------- --------------- --------------- ---------------- Net loss (1,327) (6,692) (4,849) (2,100) Preferred stock items (258) (257) (258) (257) --------------- --------------- --------------- ---------------- Net loss applicable to common $ (1,585) $ (6,949) $ (5,107) $ (2,357) =============== =============== =============== ================ Net loss per share $ (0.06) $ (0.28) $ (0.21) $ (0.09) =============== =============== =============== ================ 1998 Contract research revenue $ 1,000 $ - $ 1,488 $ 3,000 Licensed research revenue - 10,667 1,000 518 Operating expenses (9,260) (9,534) (8,493) (10,116) --------------- --------------- --------------- ---------------- Loss from operations (8,260) 1,133 (6,005) (6,598) Other income 311 402 524 431 --------------- --------------- --------------- ---------------- Net income (loss) (7,949) 1,535 (5,481) (6,167) Preferred stock items - (190) (258) (257) --------------- --------------- --------------- ---------------- Net income (loss) applicable to common $ (7,949) $ 1,345 $ (5,739) $ (6,424) =============== =============== =============== ================ Net income (loss) per share $ (0.35) $ 0.06 $ (0.25) $ (0.27) =============== =============== =============== ================
F15
EX-10.72 2 EXHIBIT 10.72 Exhibit 10.72 INDICATION OF INTEREST THIS INDICATION OF INTEREST (this "INDICATION") is made as of October 20, 1999 between The Immune Response Corporation, a Delaware corporation (the "COMPANY"), and the counter signatories hereto on the date of this Indication (each such signatory is an "OFFEREE" and all such signatories are, collectively, the "OFFEREES"). WHEREAS, subject to the terms and conditions set forth in this Indication, the Company desires to offer, from time to time, to the Offerees and the Offerees would have an interest in receiving one or more offers from the Company to purchase from the Company shares of the Company's common stock, par value $.0025 per share (the "COMMON STOCK"). IN CONSIDERATION of the mutual covenants contained in this Indication and for other good and valuable consideration the receipt and adequacy are hereby acknowledged, the Company and the Offerees agree as follows: 1. DEFINITIONS. Unless otherwise defined herein, the following terms shall have the meanings set forth in this Section 1. (a) "AVERAGE PRICE" shall mean the daily volume weighted average price of the Common Stock on the NASDAQ or a Subsequent Market as reported by Bloomberg Financial Services, Inc. (or any successor to its function of reporting stock prices) using the AQR function. (b) "MATERIAL ADVERSE EFFECT" shall mean any adverse affect on the business, results of operations, assets, prospects, or condition (financial or otherwise) of the Company and its subsidiaries, taken as a whole. (c) "NASDAQ" shall mean the Nasdaq National Market. (d) "REGISTRATION STATEMENT" shall mean the Company's registration statement (registration no. 333-83195) on Form S-3, as filed with the Securities and Exchange Commission (the "Commission") on July 19, 1999, as amended on August 20, 1999 (and all exhibits thereto) and as may be further amended or supplemented from time to time to reflect the offer of the Shares to the Offerees pursuant to the terms hereunder and to reflect other changes required to be included therein by applicable securities laws. (e) "SETTLEMENT DATE" shall mean the twentieth Trading Day immediately following a Closing Date (as defined in Section 2(b)). (f) "SETTLEMENT DATE PRICE" shall mean the product of (i) .94 and (ii) the average of the Average Prices for the twenty Trading Days during the period between a Closing Date and the applicable Settlement Date, PROVIDED, that the number of Trading Days used in the calculation of such average price shall not include any Trading Days in which the Average Price is less than $4.00 -1- and a pro rata of the Trading Days in which the average price is less than $4 out of the twenty Trading Days will be deducted from the aggregate Purchase Price. (g) "SHARES" shall mean, collectively, the shares of Common Stock which may be offered from time to time pursuant to the terms hereof. (h) "SUBSEQUENT MARKET" shall mean either the New York Stock Exchange, the American Stock Exchange or the Nasdaq SmallCap Market. (i) "TRADING DAY" means (a) a day on which the Common Stock is traded on the NASDAQ or on the Subsequent Market on which the Common Stock is then listed or quoted, as the case may be, or (b) if the Common Stock s not listed on the NASDAQ or on a Subsequent Market, a day on which the Common Stock is traded in the over-the-counter market, as reported by the OTC Bulletin Board, or (c) if the Common Stock is not quoted on the OTC Bulletin Board, a day on which the Common Stock is quoted in the over-the-counter market as reported by the National Quotation Bureau Incorporated (or any similar organization or agency succeeding its functions of reporting prices); PROVIDED, that in the event that the Common Stock is not listed or quoted as set forth in (a), (b) and (c) hereof, then Trading Day shall mean any day except Saturday, Sunday and any day which shall be a legal holiday or a day on which banking institutions in the State of New York are authorized or required by law or other government action to close. 2. PRICING AND ADJUSTMENT. (a) Subject to the terms and conditions set forth herein, for a period of twelve (12) months from the date hereof, the Offerees, severally and not jointly, would be interested in receiving one or more offers by the Company to acquire Shares for an aggregate purchase price of up to Thirty Million Dollars ($30,000,000) at a per Share purchase price equal to the Average Price on the applicable offer date (the "PURCHASE PRICE"). (b) During the twelve (12) months from the date hereof, the Company may offer to the Offerees from time to time Shares (the "OFFER(S)") by delivering to the Offerees a written offer indicating the aggregate Purchase Price for Shares offered pursuant to such Offer ("OFFER NOTICE"), PROVIDED, that, the Company may not deliver more than one (1) Offer Notice during any thirty (30) day period. The closing of each accepted Offer shall take place two (2) Trading Days following the indication in writing of an Offeree of its acceptance to purchase its pro-rata portion of the Shares subject to an Offer (the "CLOSING DATE"). (c) If the Average Price on the Trading Day immediately preceding the receipt by the Offerees of the respective Offer Notice shall (i) be less than $5.50, then the aggregate Purchase Price of the applicable Offer shall be Three Million Dollars ($3,000,000), (ii) be between $5.50 and $6.00, then the aggregate Purchase Price of the applicable Offer shall be Three Million Five Hundred Thousand Dollars ($3,500,000) and (iii) exceed $6.00, then the aggregate Purchase Price of the applicable Offer shall be Four Million Dollars ($4,000,000). (d) The closing of each accepted Offer shall take place on the applicable Closing Date at the offices of Pillsbury Madison & Sutro LLP, 235 Montgomery Street, San Francisco, CA 94104. At each Closing Date, the Company will deliver stock certificates registered in the name of each -2- Offeree representing the Shares to be sold to such Offeree and each Offeree shall deliver the Purchase Price for the Shares being purchased by it in United States dollars in immediately available funds by wire transfer to an account designated in writing by the Company for such purpose. An Offeree shall have the option to require the Company to deliver the Shares purchased by it to The Depositary Trust Company on such Offeree's behalf. (e) If on any Settlement Date, (i) the Purchase Price shall exceed the Settlement Date Price, then the Company shall issue to each Offeree, on a pro rata basis, a number of Shares equal to the quotient obtained by dividing (A) the number of Shares purchased at the Closing Date multiplied by the difference between the Purchase Price and the Settlement Date Price by (B) the Average Price on the Settlement Date and (ii) the Settlement Price shall exceed the Purchase Price, then each Offeree shall pay to the Company a sum equal to the product of (A) the number of Shares acquired by such Offeree at the applicable Offer and (B) the difference between the Purchase Price and the Settlement Date Price. (f) On a Settlement Date, each Offeree shall have the right, on a pro rata basis, to increase the amount of the applicable Offer by an aggregate of up to $2,500,000 (the "ADDITIONAL AMOUNT"). In such event, the number of Shares subject to the applicable Offer Notice shall be increased by a number equal to the quotient obtained by dividing the Additional Amount by the Settlement Date Price. (g) All stock prices referred to herein are subject to equitable adjustment for stock splits, recapitalizations and similar events. 3. FILING OF SUPPLEMENTS TO THE REGISTRATION STATEMENT. It shall be a condition to the Offerees' acceptance of any Offer that, on or prior to each Closing Date, the Company shall file with the Commission a supplement to the Registration Statement or prospectus thereto in order to evidence the offer of the Shares to the Offerees pursuant to the terms hereto. On each Settlement Date, the Company shall file with the Commission a supplement to the Registration Statement or prospectus thereto in order to evidence the offer, if any, of additional Shares to the Offerees pursuant to Sections 2(e) and (f) hereunder. 4. CONDITIONS PRECEDENT. The Company understands that the Offerees will not accept any Offer to purchase Shares pursuant to an Offer Notice unless each of the following conditions is satisfied or waived by the appropriate Offeree: (a) ACCURACY OF THE COMPANY'S REPRESENTATIONS AND WARRANTIES. The representations and warranties of the Company contained herein shall be true and correct as of the applicable Closing Date as if first made on such date; (b) REGISTRATION STATEMENT. The Registration Statement shall have remained effective under the Securities Act of 1933, as amended (the "Securities Act") at all times, not subject to any actual or threatened stop order or subject to any actual or threatened suspension at any time prior to the applicable Closing Date; -3- (c) ADVERSE CHANGES . Since the date hereof, no event or series of events which reasonably would have or result in a Material Adverse Effect shall have occurred; (d) NO SUSPENSIONS OF TRADING IN COMMON STOCK . Trading in the Common Stock shall not have been suspended by the Commission, the NASDAQ or a Subsequent Market at any time since the date hereof; (e) LISTING OF COMMON STOCK . The Common Stock shall have been at all times since the date hereof listed for trading on the NASDAQ or a Subsequent Market; (f) SHAREHOLDER APPROVAL . No approval of the shareholders of the Company shall be required under the rules of the Nasdaq Stock Market or a Subsequent Market on which the Common Stock is then traded or listed for trading in order to issue all of the Shares hereunder. 5. FEES. Concurrently with the execution of this Indication, the Company shall reimburse the Offerees $25,000 of their out of pocket expenses incurred in connection with the negotiation and preparation of this Indication. Other than the amount contemplated in the immediately preceding sentence, each party shall pay the fees and expenses of its advisers, counsel, accountants and other experts, if any, and all other expenses incurred by such party incident to the negotiation, preparation, execution, delivery and performance of this Indication. 6. REPRESENTATIONS, WARRANTIES AND COVENANTS OF THE COMPANY. the Company represents, warrants and covenants to each Offeree as follows: (a) The Company has been duly incorporated and is validly existing and in good standing under the laws of the State of Delaware, with full corporate power and authority to own, lease and operate its properties and to conduct its business as currently conducted, and is duly registered and qualified to conduct its business and is in good standing in each jurisdiction or place where the nature of its properties or the conduct of its business requires such registration or qualification, except where the failure to register or qualify could not, individually or in the aggregate, have a Material Adverse Effect; (b) The Company is current in all of its reporting obligations under the Securities Exchange Act of 1934, as amended (the "Exchange Act") and has timely made all filings required thereunder. The financial statements of the Company included in the Registration Statement comply in all material respects with applicable accounting requirements and the rules and regulations of the Commission with respect thereto as in effect at the time of filing. Such financial statements have been prepared in accordance with generally accepted accounting principles applied on a consistent basis during the periods involved, except as may be otherwise specified in such financial statements or the notes thereto, and fairly present in all material respects the financial position of the Company and its consolidated subsidiaries as of and for the dates thereof and the results of operations and cash flows for the periods then ended, subject, in the case of unaudited statements, to normal, immaterial, year-end audit adjustments. (c) The Company has furnished each Offeree with copies of the Registration Statement. At the time of their respective filing and on the date hereof, the Registration Statement did and do -4- not include any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements contained therein, in light of the circumstances under which they were made, not misleading; (d) The Shares have been duly reserved for issuance for the Offerees, are duly authorized and validly issued and when issued and delivered against payment therefor, will be fully paid and nonassessable; (e) The execution, delivery and performance of this Indication by the Company and the consummation by the Company of the transactions contemplated hereby do not and will not (i) conflict with or violate any provision of its certificate of incorporation, bylaws or other charter documents, or (ii) conflict with, or constitute a default (or an event which with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement, loan, credit facility, indenture or instrument (with respect to such indentures and instruments, evidencing a Company debt or otherwise) to which the Company or any subsidiary thereof is a party or by which any property or asset of the Company or any subsidiary thereof is bound or affected, or (iii) result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or governmental authority to which the Company is subject (including Federal and state securities laws and regulations), or by which any property or asset of the Company is bound or affected, except in the case of each of clauses (ii) and (iii), as could not, individually or in the aggregate, have or result in a Material Adverse Effect. (f) Except as disclosed herein, no authorization, approval, filing with or consent of any governmental body is required for the issuance and sale of the Shares; (g) Since September 30, 1999, the Company has not incurred any material liabilities or material obligations, direct or contingent, or entered into any material transactions not in the ordinary course of business, and there has not been any change in its capitalization or any Material Adverse Effect, except as set forth on Schedule A hereto; and (h) The Company has sufficient title and ownership of all trademarks, service marks, trade names, copyrights, patents, trade secrets and other proprietary rights necessary for its business as now conducted and as proposed to be conducted as described in the Registration Statements without any conflict with or infringement of the rights of others. 7. CERTAIN TRADING RESTRICTIONS. Each Offeree warrants and represents for itself and for no other Offeree that it has no established short position in the Common Stock on the date of this Indication and has not had any short position in the securities of the Company at any time during the twelve months prior to the date of this Indication. From and after first Closing Date and during the period in which Company is permitted to offer Shares to the Offerees pursuant to the terms hereof, each Offeree agrees for itself that it will not enter into any Short Sales (as hereinafter defined). For purposes of this Section, a "Short Sale" by an Offeree shall mean a sale of Common Stock by an Offeree that is marked as a short sale and that is made at a time when there is no equivalent offsetting long position in the Common Stock held by such Offeree. For purposes of determining whether there is an equivalent offsetting long position in the Common Stock held by an Offeree on any date of computation, shares of Common Stock actually held by the Offeree and Shares of -5- Common Stock that are issuable by operation of Section 2 hereof shall be considered held long by such Offeree; however, shares of Common Stock that are issuable pursuant to convertible or exchangeable share of preferred stock or debt of the Company shall not be considered held long. 8. PUBLICITY. Neither the Company nor any Offeree shall issue any press release or make any other public announcement relating to this Indication which has not been mutually agreed to by the Company and each Offeree. 9. GOVERNING LAW. This Indication shall be governed by and interpreted in accordance with the laws of the State of New York without giving effect to the rules governing the conflicts of laws. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the city of New York, borough of Manhattan, for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein and hereby irrevocably waives and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is improper. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof to such party at the address in effect for notices to it under this Indication and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law. 10. NOTICES. All notices and other communications provided for or permitted hereunder shall be made in writing by hand delivery, express overnight courier, registered first class mail, overnight courier, or facsimile, initially to the address set forth below, and thereafter at such other address, notice of which is given in accordance with the provisions of this Section. if to the Company: The Immune Response Corporation 5935 Darwin Court Carlsbad, CA 92008 Attn: Howard Sampson Vice President, Finance, Chief Financial Officer, Treasurer And Secretary Telephone: (760) 431-7080 Facsimile: (760) 431-9420 if to a Offeree: to the address indicated under such Offeree's name on the signature pages hereto All such notices and communications shall be deemed to have been duly given: when delivered by hand, if personally delivered; three (3) business days after being deposited in the mail, postage prepaid, if mailed; the next business day after being deposited with an overnight courier, if deposited with a nationally recognized, overnight courier service; when receipt is acknowledged, if sent by facsimile. -6- 11. ENTIRE UNDERSTANDING. This Indication constitutes the entire understanding of the parties with respect to the subject matter hereof and supersedes all prior oral or written relating thereto. 12. COUNTERPARTS. This Indication may be executed by facsimile signature and in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. -7- IN WITNESS WHEREOF, this Indication of Interest was duly executed on the date first written above. THE IMMUNE RESPONSE CORPORATION By: /s/ Howard Sampson ------------------------------------------ Name: Howard Sampson Title: Vice President, Finance, Chief Financial Officer, Treasurer and Secretary [REMAINDER OF PAGE LEFT BLANK SIGNATURE PAGES FOR OFFEREES FOLLOWS] -8- STRONG RIVER INVESTMENTS, INC. By: /s/ Keith L. Hernandez -------------------------------------------- Name: Keith L. Hernandez Title: Attorney-In-Fact Address for Notice: Strong River Investments, Inc. c/o Cavallo Capital Corp. 505 Park Avenue New York, NY 10022 Facsimile No.: (212) 651-9010 Attn: Avi Vigder With copies to: Robinson Silverman Pearce Aronsohn & Berman LLP 1290 Avenue of the Americas New York, NY 10104 Facsimile No.: (212) 541-4630 and (212) 541-1432 Attn: Kenneth L. Henderson, Esq. Eric L. Cohen. Esq. [REMAINDER OF PAGE LEFT BLANK SIGNATURE PAGE FOR ADDITIONAL OFFEREE FOLLOWS] -9- SCHEDULE A DISCLOSURE SCHEDULE As part of a Securities Purchase Agreement, dated April 24, 1998 between the Company and Themis Partners, L.P., Heracles Fund, Brown Simpson Strategic Growth Fund, Ltd. and Brown Simpson Strategic Growth Fund, L.P. and any successors thereto, (the "Buyers") (the "Agreement") the Company has an obligation to at all times have authorized, and reserved for the purpose of issuance, no less than 150% of the number of shares of Common Stock needed to cover the conversion of the Series F Convertible Preferred Stock issued under the Agreement into shares of Common Stock. The Company has not yet registered approximately 850,000 shares of Common Stock needed to remain in compliance with that obligation. The Company is currently in discussions with the Buyers regarding the registration of such additional shares and of the possibility of obtaining a waiver to such obligation. -10- EX-10.73 3 EXHIBIT 10.73 EXHIBIT 10.73 PENNSYLVANIA BRANDYWINE OPERATING PARTNERSHIP, L.P., LANDLORD AND THE IMMUNE RESPONSE CORPORATION TENANT FOR 680 ALLENDALE ROAD, KING OF PRUSSIA, PA
TABLE OF CONTENTS PAGE 1. SUMMARY OF DEFINED TERMS...............................................1 2. PREMISES...............................................................3 3. TERM...................................................................3 4. CONSTRUCTION BY LANDLORD...............................................3 5. FIXED RENT; SECURITY DEPOSIT...........................................4 6. ADDITIONAL RENT........................................................5 7. UTILITIES.............................................................11 8. SIGNS; USE OF PREMISES AND COMMON AREAS...............................11 9. ENVIRONMENTAL MATTERS.................................................13 10. TENANT'S ALTERATIONS..................................................15 11. CONSTRUCTION LIENS....................................................17 12. ASSIGNMENT AND SUBLETTING.............................................18 13. LANDLORD'S RIGHT OF ENTRY.............................................22 14. REPAIRS AND MAINTENANCE...............................................23 15. INSURANCE; SUBROGATION RIGHTS.........................................24 16. INDEMNIFICATION.......................................................26 17. QUIET ENJOYMENT.......................................................27 18. FIRE DAMAGE...........................................................27 19. SUBORDINATION; RIGHTS OF MORTGAGEE....................................28 -ii- 20. CONDEMNATION..........................................................29 21. ESTOPPEL CERTIFICATE..................................................30 22. DEFAULT...............................................................30 23. CURING TENANT'S DEFAULTS..............................................35 24. LANDLORD'S REPRESENTATIONS AND WARRANTIES.............................36 25. SURRENDER.............................................................36 26. RULES AND REGULATIONS.................................................28 27. GOVERNMENTAL REGULATIONS..............................................37 28. NOTICES...............................................................38 29. BROKERS...............................................................38 30. CHANGE OF BUILDING/PROJECT NAME.......................................38 31. LANDLORD'S LIABILITY..................................................38 32. AUTHORITY.............................................................38 33. NO OFFER..............................................................39 34. [RENEWAL..............................................................39 35. ROOF RIGHTS...........................................................39 36. MISCELLANEOUS PROVISIONS..............................................40 37. WAIVER OF TRIAL BY JURY...............................................45 38. CONSENT TO JURISDICTION...............................................45
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EXHIBITS EXHIBIT "A" - SPACE PLAN OF PREMISES EXHIBIT "B" - RENTAL SCHEDULE EXHIBIT "C" - PARKING AREA EXHIBIT "D" - CONSTRUCTION DOCUMENTS EXHIBIT "E" - LIST OF MATERIALS AND PERMITS EXHIBIT "F" - FORM OF NON-DISTURBANCE AGREEMNET EXHIBIT "G" - RULES AND REGULATIONS
-iv- LEASE THIS LEASE ("Lease") entered into as of the 1st day of November, 1999, between BRANDYWINE OPERATING PARTNERSHIP, L.P., a Delaware limited partnership having its principal office at 16 Campus Boulevard, Suite 150, Newtown Square, Pennsylvania 19073 ("Landlord"), and THE IMMUNE RESPONSE CORPORATION, a Delaware corporation with its principal place of business at 5935 Darwin Court, Carlsbad, California ("Tenant"). WITNESSETH In consideration of the mutual covenants herein set forth, and intending to be legally bound, the parties hereto covenant and agree as follows: 1. SUMMARY OF DEFINED TERMS. The parties agree that the following defined terms, as used in this Lease, shall have the meanings and shall be construed as set forth below: (a) "BUILDING": The Building owned by Landlord in fee and located at 680 Allendale Road, King of Prussia, Pennsylvania, and identified as Unit 680 in the condominium complex known as Brandywine King of Prussia. (b) "PROJECT": The Building, the land, the portions of the Parking Area (as hereinafter defined) which are for the exclusive use of Tenant and all other improvements located at 680 Allendale Road, King of Prussia, Pennsylvania. (c) "PREMISES": Unit No. 680, which the parties hereto hereby stipulate and agree is the entire 52,528 square feet of the Building shown on the space plan attached hereto as Exhibit "A" and made a part hereof. (d) "TERM": From November 1, 1999 to October 31, 2011. (e) "FIXED RENT": Tenant shall pay to Landlord fixed rent as set forth in the Rental Schedule attached hereto as Exhibit "B" and made a part hereof. (f) "SECURITY DEPOSIT": $35,000.00; (g) "EFFECTIVE DATE": As of November 1, 1999; (h) "TENANT'S ALLOCATED SHARE": 100%: (i) "RENTABLE AREA": Premises 52,528 ft. Building 52,528 ft. -1- (j) "PERMITTED USES": Tenant's use of the Premises shall be limited to general bio-pharmaceutical research and development, product production and distribution, including, general office and industrial uses and storage incidental thereto, in accordance with all applicable laws and in keeping with existing governmental zoning and permitted uses. (k) "BROKER": CB Richard Ellis; (l) "NOTICE ADDRESS/CONTACT" Tenant: The Immune Response Corporation 5935 Darwin Court Carlsbad, CA 92008 Attn: Paula B. Atkins Vice President - Administration With a copy to: Eric A. Kremer, Esquire Pillsbury, Madison & Sutro LLP Carmel Valley Center One 11975 El Camino Real Suite 200 San Diego, CA 92130-2593 Landlord: BRANDYWINE OPERATING PARTNERSHIP, L.P. 14 Campus Blvd., Suite 100 Newtown Square, Pennsylvania 19073 Attn: Anthony A. Nichols, Jr. Vice President of Operations With a copy to: Brandywine Realty Trust 14 Campus Blvd. Suite 100 Newtown Square, Pennsylvania 19073 Attn: Brad A. Molotsky, Esquire General Counsel (m) "TENANT'S STANDARD INDUSTRIAL CLASSIFICATION NUMBER": 2836. -2- (n) "ADDITIONAL RENT": All sums of money or charges required to be paid by Tenant under this Lease other than Fixed Rent, whether or not such sums or charges are designated as "Additional Rent". (o) "RENT": All Annual Fixed Rent, monthly installments of Annual Fixed Rent, Fixed Rent and Additional Rent payable by Tenant to Landlord under this Lease. (p) "PARKING AREA": The part of the Project which shall at all times include not less than 100 parking spaces allocated for the exclusive use of Tenant, as outlined in red on the site plan attached hereto as Exhibit C and made a part hereof. 2. PREMISES. Landlord does hereby lease, demise and let unto Tenant and Tenant does hereby hire and lease from Landlord the Premises for the Term, upon the provisions, conditions and limitations set forth herein. 3. TERM. The Term of this Lease shall commence (the "Commencement Date") on the Effective Date, which shall be as of November 1, 1999, and shall expire on October 31, 2011. 4. CONSTRUCTION BY LANDLORD. Landlord hereby agrees to perform the construction services set forth below at its sole cost and expense: (a) Landlord hereby agrees to replace the entranceway steps on the walkway from the Building located on the Southeast corner of the Building closest to 3rd Avenue and Allendale Road. (b) Landlord hereby agrees to install a screen around the equipment located on the Southeast side of the Premises facing 660 Allendale Road. (c) Landlord hereby agrees to reconfigure and repair the Parking Area in accordance with the site plan attached hereto as Exhibit C-1 and made a part hereof and to re-stripe and re-coat the parking lot. (d) The work to be performed by Landlord in accordance with subsections (a), (b) and (c) above shall be referred to collectively herein as the "Landlord's Work." (e) Except as set forth in subsections (a) and (b) above, Landlord is not obligated to do any construction. However, Landlord shall provide Tenant with a construction allowance equal to $10.00 psf or $525,280.00 (five hundred twenty five thousand two hundred eighty dollars). Such allowance shall be paid by Landlord upon substantial completion of the Tenant's Work as described on the enclosed construction documents as part of Exhibit "D" attached hereto and made a part hereof. Landlord acknowledges that the Landlord has reviewed and approved the Tenant's proposed construction drawings. Subject to the terms and conditions -3- of this Lease, Tenant will have the sole and exclusive right to construct its own tenant improvements. 5. FIXED RENT; SECURITY DEPOSIT. (a) Tenant shall pay to Landlord without notice or demand, and without set-off, the annual Fixed Rent payable in the monthly installments of Fixed Rent as set forth in Article 1(e), in advance on the first day of each calendar month during the Term by wire transfer of immediately available funds to the account at First Union National Bank, account no. 2030000359075; such transfer to be confirmed to Brandywine Realty Services Corporation's accounting department (610-325-5622 - fax) by written facsimile with ABA routing number 031000503. Notwithstanding the immediately preceding sentence, the first month's installment and the security deposit shall be paid upon the execution of this Lease by Tenant by two separate checks. Otherwise, Fixed Rent shall not commence nor be due and owing until the Commencement Date. (b) In the event any Fixed Rent or Additional Rent, charge, fee or other amount due from Tenant under the terms of this Lease are not paid to Landlord within ten (10) days of the date due, Tenant shall also pay as Additional Rent a service and handling charge equal to ten (10%) percent of the total payment then due. This provision shall not prevent Landlord from exercising any other remedy herein provided or otherwise available at law or in equity in the event of any default by Tenant. (c) Tenant shall be required to pay a security deposit of Thirty Five Thousand Dollars ($35,000) under this Lease (the "Collateral"), as security for the prompt, full and faithful performance by Tenant of each and every provision of this Lease and of all obligations of Tenant hereunder. Landlord hereby acknowledges that Tenant shall have a credit against the security deposit in the amount of Twenty-Seven Thousand Five Hundred Sixteen Dollars and Sixty-Seven Cents ($27,516.67), representing the existing security deposit under the Lease currently in effect between Landlord and Tenant (the "Current Lease"). No interest shall be paid to Tenant on the Collateral. If Tenant fails to perform any of its obligations hereunder after applicable cure periods have expired, if any, Landlord may use, apply or retain the whole or any part of the Collateral for the payment of (i) any rent or other sums of money which Tenant may not have paid when due, (ii) any sum expended by Landlord on Tenant's behalf in accordance with the provisions of this Lease, and/or (iii) any sum which Landlord may expend or be required to expend by reason of Tenant's default, including any damage or deficiency in or from the reletting of the Premises as provided in this Lease. The use, application or retention of the Collateral, or any portion thereof, by Landlord shall cure Tenant's default to the extent of Landlord's use or application thereof, but shall not otherwise prevent Landlord from exercising any other right or remedy provided by this Lease or by law (it being intended that Landlord shall not first be required to proceed against the Collateral) and shall not operate as a limitation on any recovery to which Landlord may otherwise be entitled. If any portion of the Collateral is used, applied or retained by Landlord for the purposes set forth above, Tenant agrees, within ten (10) days after -4- the written demand therefor is made by Landlord, to deposit cash with the Landlord in an amount sufficient to restore the Collateral to its original amount. If Tenant shall fully and faithfully comply with all of the provisions of this Lease, the Collateral, or any balance thereof, shall be returned to Tenant without interest within thirty (30) days after the expiration of the Term or upon any later date after which Tenant has vacated the Premises. In the absence of evidence satisfactory to Landlord of any permitted assignment of the right to receive the Collateral, or of the remaining balance thereof, Landlord may return the same to the original Tenant, regardless of one or more assignments of Tenant's interest in this Lease or the Collateral. In such event, upon the return of the Collateral, or the remaining balance thereof to the original Tenant, Landlord shall be completely relieved of liability under this Paragraph or otherwise with respect to the Collateral. In the event of a sale of the Project and Building of which the Premises form a part, Landlord shall have the right to transfer the Collateral to the vendee or lessee and Landlord shall thereupon be released by Tenant from all liability for the return of such Collateral; and Tenant agrees to look solely to the new landlord for the return of said Collateral, and the provisions hereof apply to every transfer or assignment made of the Collateral to a new landlord. Tenant further covenants that it will not assign or encumber or attempt to assign or encumber the Collateral and that neither Landlord nor its successors or assigns shall be bound by any such assignment, encumbrance, attempted assignment or attempted encumbrance. The Collateral shall not be mortgaged, assigned or encumbered in any manner whatsoever by Tenant without the prior written consent of Landlord. 6. ADDITIONAL RENT. (a) Commencing on the Commencement Date, and in each calendar year thereafter during the Term (as same may be extended), Tenant shall pay to Landlord, as Additional Rent, within thirty (30) days after Landlord certifies to Tenant the amount thereof, the following charges ("Recognized Expenses"), without deduction or set off, such charges to be based upon Tenant's Allocated Share of such charges, as stated in Article 1(h) herein. (1) INSURANCE PREMIUMS. All premiums paid or payable by Landlord for insurance with respect to the Project, which premiums shall be reasonable in context of both the Project and customary commercial insurance coverage in the marketplace, as follows: (a) fire and extended coverage insurance (including demolition and debris removal); (b) insurance against Landlord's rental loss or abatement (but not including business interruption coverage on behalf of Tenant), from damage or destruction from fire or other casualty; (c) Landlord's comprehensive liability insurance (including bodily injury and property damage) and boiler insurance; and (d) such other insurance as Landlord or any reputable mortgage lending institution holding a mortgage on the Premises may require. -5- If the coverage period of any of such insurance obtained by Landlord commences before or extends beyond the Term, the premium therefore shall be prorated to the Term. If any such insurance is provided by blanket coverage, the part of the premium allocated to the Project shall be equitably determined by Landlord but shall not exceed the amount of premium due if insurance was provided by a policy only insuring the Project. Should Tenant's occupancy or use of the Premises at any time change and thereby cause an increase in such insurance premiums on the Premises, Building and/or Project, Tenant shall pay to Landlord the reasonable amount of such increase. (2) OPERATING EXPENSES. The reasonable costs and expenses related to the following activities with regard to the Project incurred and paid by Landlord during the Term, including: (a) All costs and expenses relating to taxes, removing snow, ice and debris and maintaining all landscape areas (including the placing and replanting of flowers, shrubbery and trees, maintaining and repairing all other exterior improvements on the Project, all repairs and compliance costs necessitated by laws enacted or which become effective after the commencement date hereof (including, without limitation, any additional regulations or requirements enacted after the date hereof regarding the Americans With Disabilities Act (as such applies to the Project or common areas but not to any individual tenant's space), if applicable) required of Landlord under applicable laws, rules and regulations. Landlord's obligation to provide snow removal services shall be limited to the parking areas and the sidewalk entrances. (b) All costs and expenses incurred by Landlord for all replacement or repairs to the Parking Area, including, but not limited to, re-striping and re-coating the Parking Area, once Landlord has completed the reconfiguration and repair of the Parking Area and the re-striping and re-coating of the parking lot in accordance with Section 4(c) hereof. (c) All costs and expenses incurred by Landlord for ordinary compliance type environmental testing, sampling or monitoring required by statute, regulation or order of governmental authority, necessary except any costs or expenses incurred in conjunction with the spilling or depositing of any hazardous substance for which any person or other tenant is legally liable. (d) Capital expenditures to the extent considered as an Operating Expense under this Article 6, shall be included as Operating Expenses solely to the extent of the amortized costs of same over the useful life of the improvement in accordance with generally accepted accounting principles. (3) EXCLUSIONS. Notwithstanding the foregoing, the term "Recognized Expenses" shall NOT include any of the following: -6- (a) Repairs or other work occasioned by fire, windstorm or other insured casualty plus and "deductibles" or by the exercise of the right of eminent domain; (b) Leasing commissions, accountants', consultants', auditors' or attorney's fees, costs and disbursements and other expenses incurred in connection with negotiations or disputes with other tenants or prospective tenants or other occupants, or associated with the enforcement of any other leases or the defense of Landlord's title to or interest in the real property or any part thereof; (c) Costs incurred by Landlord in connection with construction of the Building and related facilities, the correction of latent defects in construction of the Building or the discharge of Landlord's Work; (d) Costs (including permit, licenses and inspection fees) incurred in renovating or otherwise improving or decorating, painting, or redecorating the Building or space for other tenants or other occupants or vacant space; (e) Costs of any items or services sold or provided to tenants (including Tenant) for which Landlord is reimbursed by such tenants; (f) Depreciation and amortization; (g) Costs incurred due to a breach by Landlord or any other tenant of the terms and conditions of any lease; (h) Overhead and profit increment paid to subsidiaries or affiliates of Landlord for management or other services on or to the Building or for supplies, utilities or other materials, to the extent that the costs of such services, supplies, utilities or materials exceed the reasonable costs that would have been paid had the services, supplies or materials been provided by unaffiliated parties on a reasonable basis without taking into effect volume discounts or rebates offered to Landlord as a portfolio purchaser; (i) Interest on debt or amortization payments on any mortgage or deeds of trust or any other borrowings and any ground rent; (j) Ground rents or rentals payable by Landlord pursuant to any over-lease; (k) Any compensation paid to clerks, attendants or other persons in commercial concessions operated by Landlord; -7- (l) All items and services for which Tenant reimburses Landlord or which Landlord provides selectively to one or more tenants or occupants of the building (other than Tenant) without reimbursement; (m) Costs incurred in managing or operating any "pay for" parking facilities within the Project; (n) Any fines or fees for Landlord's failure to comply with governmental, quasi-governmental, or regulatory agencies' rules and regulations; or (o) Legal, accounting and other expenses related to Landlord's financing, re-financing, mortgaging or selling the Building or the Project. (b) Tenant shall be required to pay all Taxes imposed on the Project. Taxes shall be defined as all taxes, assessments and other governmental charges ("Taxes"), including special assessments for public improvements or traffic districts which are levied or assessed against the Project during the Term (as may be extended) or, if levied or assessed prior to the Term, which properly are allocable to the Term, and real estate tax appeal expenditures incurred by Landlord to the extent of any reduction resulting thereby. In the event that the real estate tax bills for the property of which the Project is apart are broken down to tax separately the Building and the land surrounding the Building that is designated as the parking area, then the Tenant's responsibility shall be to pay all of the real estate taxes set forth in said real estate tax bills. In the event that there is not a separate real estate tax bill for the Building and the land surrounding the Building, as noted aforesaid, then the Tenant shall be required to pay its pro-rata portion of the real estate tax bills for the property of which the Project is a part in two (2) components as follows: (i) with regard to that portion of the real estate tax bills relating to all of the buildings located on the property of which the Project is a part, the Tenant shall pay its pro-rata share of said real estate taxes based upon the square footage of the Premises to the total square footage of all buildings located on the property of which the Project is a part, and (ii) with regard to that portion of the real estate tax bills representing a tax assessment for the land of the property of which the Project is a part, including the Parking Area and the land under the above-described buildings, the Tenant shall pay its equitable share of real estate taxes for said land on a pro-rata basis. Nothing herein contained shall be construed to include as Taxes: (A) any inheritance, estate, succession, transfer, gift, franchise, corporation, net income or profit tax or capital levy that is or may be imposed upon Landlord or (B) any Taxes resulting from a transfer of the Building or the Project; provided, however, that if at any time during the Term the method of taxation prevailing at the commencement of the Term shall be altered so that in lieu of or as a substitute for the whole or any part of the taxes now levied, assessed or imposed on real estate as such there shall be levied, assessed or imposed (i) a tax on the rents received from such real estate, or (ii) a license fee measured by the rents receivable by Landlord from the Premises or any -8- portion thereof, or (iii) a tax or license fee imposed upon Premises or any portion thereof, then the same shall be included in the computation of Taxes hereunder. (c) Beginning on the Commencement Date, with the payment for the month of November, 1999 due on the date of the execution of this Lease, Tenant shall pay, in monthly installments in advance, on account of Tenant's Allocated Share of Recognized Expenses and Taxes, the estimated amount of such Recognized Expenses and Taxes for such year as determined by Landlord in its reasonable discretion and as set forth in a notice, such notice to include the basis for such calculation, to be provided to Tenant prior to such date. Until the estimate is modified from time to time by Landlord via written notice to Tenant at least thirty (30) days prior to any adjustment, the monthly installments to be paid by Tenant on account of Tenant's Allocated Share of Recognized Expenses and Taxes shall be based upon an annual charge of Seventy-Five Thousand Dollars ($75,000.00), which equals monthly payments in the amount of Six Thousand Two Hundred Fifty Dollars ($6,250.00) per month. Prior to the end of that year and hereafter for each successive calendar year (each, a "Lease Year"), or part thereof, Landlord shall send to Tenant a statement of projected increases in Recognized Expenses and Taxes and Landlord shall indicate what Tenant's projected share of Recognized Expenses and Taxes shall be. Said amount shall be paid in equal monthly installments in advance by Tenant as Additional Rent commencing January 1 of the applicable Lease Year. Tenant shall have the right, at its sole cost and expense, to audit or have its appointed accountant audit Landlord's records relating to Recognized Expenses and Taxes provided that any such audit may not occur more frequently than once each calendar year nor apply to any year prior to the then current calendar year. In the event Tenant's audit discloses any discrepancy in the amount of the Recognized Expenses or Taxes, Landlord and Tenant shall use their best efforts to resolve the dispute and make an appropriate adjustment, failing which they shall submit any such dispute to arbitration pursuant to the rules and under the jurisdiction of the American Arbitration Association in Delaware County, Pennsylvania. The decision rendered in such Arbitration shall be final, binding and non-appealable. The expenses of Arbitration, other than individual legal and accounting expenses which shall be the respective parties' responsibility, shall be divided equally between the parties. In the event, by agreement or as a result of an arbitration decision, it is determined that the actual recognized expenses exceeded those claimed by the Landlord by more than five percent (5%), the actual, reasonable hourly costs to Tenant of Tenant's audit (including legal and accounting costs) shall be reimbursed by Landlord. Tenant agrees not to utilize a contingent fee auditor. If during the course of any Lease Year, Landlord shall have reason to believe that the Recognized Expenses and Taxes shall be different than that upon which the aforesaid projections were originally based, then Landlord, following sixty (60) days written notice to Tenant, shall be entitled to adjust the amount by reallocating the remaining payments for such year, for the months of the Lease Year which remain for the revised projections, and to advise Tenant of an adjustment in future monthly amounts to the end result that the Recognized Expenses and Taxes shall be collected on a reasonably current basis each Lease Year. -9- In calculating the Recognized Expenses as hereinbefore described, if for thirty (30) or more days during the preceding Lease Year less than ninety-five (95%) percent of the rentable area of the Building shall have been occupied by tenants, then the Recognized Expenses attributable to the Property shall be deemed for such Lease Year to be amounts equal to the Recognized Expenses which would normally be expected to be incurred had such occupancy of the Building been at least ninety-five (95%) percent throughout such year, as reasonably determined by Landlord (i.e., taking into account that certain expenses depend on occupancy and certain expenses do not (E.G., landscaping)). Furthermore, if Landlord shall not furnish any item or items of Recognized Expenses to any portions of the Building because such portions are not occupied or because such item is not required by the tenant of such portion of the Building, for the purposes of computing Recognized Expenses, an equitable adjustment shall be made so that the item of Operating Expense in question shall be shared only by tenants actually receiving the benefits thereof. Within four (4) months following the end of each Lease Year or as soon thereafter as administratively available, Landlord shall send to Tenant an itemized statement of actual expenses incurred for Recognized Expenses and Taxes for the prior Lease Year showing the Allocated Share due from Tenant. Landlord shall use its reasonable efforts to provide Tenant with the aforesaid statements on or before April 30 of each Lease Year; provided, however, if Landlord is unable to provide such statements by April 30, Landlord shall not have been deemed to waive its right to collect any such amounts as Additional Rent. If Landlord is unable to provide final statements on or before April 30 of each Lease Year, Landlord shall provide Tenant with its unaudited internal estimates of such costs by April 30, with the caveat that the final statements may deviate from the estimate provided. In the event the amount prepaid by Tenant exceeds the amount that was actually due then Landlord shall issue a credit to Tenant in an amount equal to the over charge, which credit Tenant may apply to future payments on account of Recognized Expenses and Taxes until Tenant has been fully credited with the over charge. If the credit due to Tenant is more than the aggregate total of future rental payments, Landlord shall pay to Tenant the difference between the credit in such aggregate total. In the event Landlord has undercharged Tenant then Landlord shall send Tenant an invoice with the additional amount due, which amount shall be paid in full by Tenant within thirty (30) days of receipt. Each of the Recognized Expense and Amount of Taxes, whether requiring lump sum payment or constituting projected monthly amounts added to the Fixed Rent, shall for all purposes be treated and considered as Additional Rent and the failure of Tenant to pay the same as and when due in advance and without demand shall have the same effect as failure to pay any installment of the Fixed Rent. Landlord will provide Tenant with a copy of the real estate tax bills for the Premises promptly after the Landlord's receipt of the same. The failure of the Landlord to furnish copies of said real estate tax bills to Tenant shall not be deemed to be a default under this Lease unless the Landlord fails to furnish copies of said real estate tax bills within ten (10) days after receipt of written notice from Tenant requesting said real estate tax bills. -10- If this Lease terminates other than at the end of a calendar year, Landlord's annual estimate of Recognized Expenses and Taxes shall be accepted by the parties as the actual Recognized Expenses and Taxes for the year the Lease ends unless and until Landlord provides Tenant with actual statements in accordance with this subsection 6(c). 7. UTILITIES. From and after the Commencement Date, Tenant shall make arrangements with each utility company and public body to provide, in Tenant's name, gas, electricity, water, sewer, telephone, heat, and air conditioning necessary for Tenant's use of the Premises, and Tenant shall cause all such utilities to be separately metered, to the extent possible. Tenant shall pay directly to the companies furnishing utility service the cost of all service connection fees and the cost of all utilities consumed throughout the Term. If the water service is not separately metered, Landlord shall pay water bills for the Building, and Tenant shall pay to Landlord prior to the time when each bill becomes due an amount determined by Landlord based on the actual cost thereof attributable to Tenant's usage. In the event that Tenant fails to pay in a timely manner any sum required under this Section, Landlord shall have the right, but not the obligation, to pay any such sum. Any sum so paid by Landlord shall be deemed to be owing by Tenant to Landlord and due and payable as Additional Rent within five (5) business days after written demand therefor. Tenant's obligations for the payment of the costs incurred for utilities that serve the Premises prior to the termination of this Lease shall survive termination hereof. Landlord shall provide 7 days per week, 24 hour per day ("Working Hours"), excluding legal holidays, the Premises with heat and air-conditioning in the respective seasons for comfortable occupancy of the subject premises, and provide the Premises with electricity for lighting and usual office equipment. 8. MANAGEMENT FEE. Tenant shall be required to pay to Landlord an annual management fee ("Management Fee") in the amount of four percent (4%) of the annual fixed rent to be paid by Tenant to Landlord during the Term (as may be extended) of this Lease. The Management Fee shall be paid on a monthly basis commencing on the Commencement Date. 9. SIGNS; USE OF PREMISES AND COMMON AREAS. (a) Tenant, at its sole cost and expense and option, will provide Building and monument signage in a location and style of design acceptable to Landlord. Landlord's approval shall not be unreasonably withheld or delayed. The subject signage will be compatible with building design and shall conform with all applicable local government codes, shall be fully visible and free of any and all obstructions such as landscaping and such visibility shall be maintained throughout the Term (as may be extended). Tenant shall be required to obtain, at its sole cost and expense, all permits and approvals necessary for said signage. Landlord will cooperate with Tenant in an effort to obtain said approvals. -11- (b) Tenant may use and occupy the Premises only for the express and limited purposes stated in Article 1(j) above; and the Premises shall not be used or occupied, in whole or in part, for any other purpose without the prior written consent of Landlord, which consent shall not be unreasonably withheld or delayed, taking into consideration such factors as environmental impact, the use of other leased premises on the property of which the Premises is a part by other tenants, the effect on insurance rates of said proposed use and other reasonable factors deemed by Landlord to be relevant in its decision; provided that Tenant's right to so use and occupy the Premises shall remain expressly subject to the provisions of "Governmental Regulations", Article 30 herein. No machinery or equipment shall be permitted that shall cause excessive vibration, noise or disturbance beyond the Premises. Provided that the Tenant is not in breach of any of its obligations under this Lease and continues to pay all of its rental and additional payment obligations under this Lease, the Tenant shall have the right to vacate the Premises no more than one (1) time during each eighteen (18) month period during the Term or any renewal term of this Lease for a period of up to six (6) months. In the event that the Tenant vacates the Premises for a period longer than 6months or vacates or otherwise abandons the Premises more than one (1) time during each eighteen (18) month period during the Term or any renewal term of this Lease, Tenant shall be in default under this Lease. The term "vacate" , as used therein, shall be defined as the Tenant failing to open for business or removing substantially all of its client files or its furniture and equipment and personal property from the Premises. (c) Tenant shall not overload any floor or part thereof in the Premises or the Building which exceeds the floor loading capacity of the subject building, bringing in, placing, storing, installing or removing any large or heavy articles, and Landlord may prohibit, or may direct and control the location and size of, safes and all other heavy articles, and may require, at Tenant's sole cost and expense, supplementary supports of such material and dimensions as Landlord may deem necessary to properly distribute the weight. (d) Tenant shall not install in or for the Premises, without Landlord's prior written approval with Landlord's said approval not to be unreasonably withheld, conditioned or delayed, any equipment which requires more electric current than Landlord is required to provide under this Lease, and Tenant shall ascertain from Landlord the maximum amount of load or demand for or use of electrical current which can safely be permitted in and for the Premises, taking into account the capacity of electric wiring in the Building and the Premises and the needs of Building common areas (interior and exterior) and the requirements of other tenants of the Building, Tenant and shall not in any event connect a greater load than such safe capacity. (e) Tenant shall not commit or suffer any waste upon the Premises, Building or Project or any nuisance, or any other act or thing which may disturb the quiet enjoyment of any other tenant in the Building or Project. (f) Tenant shall have the right to use the exterior paved driveways and walkways of the Building for vehicular and pedestrian access to the Building. Attached to the Lease as Exhibit C is the Parking Area. Landlord has designated in red certain potential parking -12- spaces comprising the Parking Area designated on Exhibit C. At all times, Landlord shall designate for exclusive use by Tenant a minimum of 100 spaces for the parking of automobiles of Tenant and its employees and business visitors, incident to Tenant's permitted use of the Premises. Out of said 100 spaces, the 67 spaces that have been designated in orange will be permanent parking spaces provided for Tenant's use and shall not be relocated at any time by Landlord, except as otherwise provided for herein, without the prior written consent of Tenant (the "Permanent Spaces"). With regard to the remaining 33 spaces, said 33 spaces shall be selected by Landlord within the circle drawn in yellow (the "Yellow Area") on Exhibit D (the "33 Spaces"). Upon not less than 10 business days prior written notice to Tenant, Landlord may relocate the 33 Spaces within the Yellow Area. In connection with the Landlord's construction activities affecting the Project, Landlord shall have the right, upon not less than 10 business days prior written notice to Tenant to relocate the Permanent Spaces and/or the 33 Spaces within the area drawn in red on Exhibit D (the "Temporary Relocation Area"). In connection with the relocation of the Permanent Spaces and the 33 spaces within the Temporary Relocation Area, Landlord agrees that it: (i) shall use all reasonable efforts to minimize the impact of its construction activities on the Tenant, (ii) shall use all reasonable efforts to complete its construction activities on an expedited basis, and (iii) shall use all reasonable efforts to keep the Tenant informed, on a routine basis, in connection with the progress of its construction activities. Landlord shall have the right to establish reasonable regulations, applicable to all tenants, governing the use of or access to any interior or exterior common areas; and such regulations, when communicated by written notification from Landlord to Tenant, shall be deemed incorporated by reference hereinafter and part of this Lease. Such regulation shall not be interpreted, supplemented or modified in a manner which materially and adversely affects Tenant's use or occupancy of the premises under this Lease. The parking provided to Tenant under this subsection (f) shall be at no cost to Tenant during the Term (and any extensions thereof) and shall be exclusive to Tenant except in the event of emergency. 10. ENVIRONMENTAL MATTERS. (a) HAZARDOUS SUBSTANCES. (i) Tenant shall not, except as provided in subparagraph (ii) below, bring or otherwise cause to be brought or permit any of its agents, employees, contractors or invitees to bring in, on or about any part of the Premises, Building or Project, any hazardous substance or hazardous waste in violation of law, as such terms are or may be defined in (x) the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. 9601 ET SEQ., as the same may from time to time be amended, and the regulations promulgated pursuant thereto ("CERCLA"); the United States Department of Transportation Hazardous Materials Table (49 CFR 172.102); by the Environmental Protection Agency as hazardous substances (40 CFR Part 302); the Clean Air Act; and the Clean Water Act, and all amendments, modifications or supplements thereto; and/or (y) any other rule, regulation, ordinance, statute or requirements of any governmental or administrative agency regarding the environment (collectively, (x) and (y) shall be referred to as an "Applicable Environmental Law"). -13- (ii) Tenant may bring to and use at the Premises, hazardous substances, supplies or other items, incidental to its normal business operations under the SIC Code referenced in paragraph 1(n) above in de minimis quantities in accordance with Applicable Environmental Law. Tenant shall store and handle such substances in strict accordance with applicable Environmental Law. Notwithstanding the foregoing language contained in this subsection (ii), Tenant shall have the right to store and handle those materials listed in Exhibit E attached hereto (as the same may be updated as provided below) and made a part hereof (collectively, the "Materials"), and the storage and handling of said Materials in strict accordance with Applicable Environmental Law shall not be deemed to be a breach of this Lease. Also attached as Exhibit F is a copy of all permits obtained by Tenant from the appropriate environmental authorities permitting Tenant to utilize said Materials and Tenant hereby covenants to renew, update or obtain any and all other permits necessary in order to comply with Applicable Environmental Law. Tenant shall have the right to update the list of Materials on an annual basis and to add materials thereto, provided that the addition of any materials not set forth in Exhibit E shall be subject to at least ten (10) days' prior written notice to, and the reasonable approval of, the Landlord; provided, however, that Tenant shall be permitted to add additional materials, and the Landlord shall be deemed to have given its reasonable approval thereto provided that the Food & Drug Administration or other governmental or regulatory authority has required Tenant to utilize said additional material or materials, in which event the addition of said material or materials shall be permitted, unless said materials, it not utilized in accordance with all Applicable Environmental Law, would have a potential material, adverse environmental impact on the Building, the Project, the Premises or any operations thereon. Any added materials shall be purchased, stored, handled, utilized and disposed of in strict accordance with all Applicable Environmental Law. With regard to any Materials or additional materials utilized by Tenant in connection with this Article 10, Tenant shall be required, before receiving, storing, handling or using any said materials, to obtain all federal, state and local licenses, permits and approvals required by Applicable Environmental Law. (b) SIC NUMBERS. (i) Tenant represents and warrants that Tenant's SIC (Standard Industrial Classification) number as designated in the Standard Classification Manual prepared by the Office of Management and Budget, and as set forth in Article 1(m) hereof, is correct. Tenant represents that the specific activities intended to be carried on in the Premises are in accordance with Article 1(j). (ii) Except for the Materials permitted in accordance with Section 10(a)(ii) hereof, Tenant shall not engage in operations at the Premises which involve the generation, manufacture, refining, transportation, treatment, storage, handling or disposal of "hazardous substances" or "hazardous waste" as such terms are defined under any Applicable Environmental Law. Tenant further covenants that it will not cause or permit to exist any "discharge" (as such term is defined under Applicable Environmental Laws on or about the Premises. -14- (iii) Tenant shall, at its expense, comply with all requirements of Applicable Environmental Laws pertaining thereto. (iv) In addition, upon written request of Landlord, Tenant shall cooperate with Landlord in obtaining Applicable Environmental Laws approval of any transfer of the Building of which the Premises form a part. Specifically in that regard, Tenant agrees that it shall (1) execute and deliver all affidavits, reports, responses to questions, applications or other filings reasonably required by Landlord and related to Tenant's activities at the Premises, (2) allow inspections and testing of the Premises subject to prior notice and compliance with Tenant's security requirements, and (3) as respects the Premises occupied by Tenant, perform any requirement reasonably requested by Landlord necessary for the receipt of Applicable Environmental Laws approval, provided the foregoing shall not require interruption or modification of Tenant's permitted use of the premises for the uses permitted under the lease and shall be at no out-of-pocket cost or expense to Tenant except for clean-up and remediation costs arising from Tenant's activities at the Premises. (c) ADDITIONAL TERMS. (i) In the event of Tenant's failure to comply in full with this Article, Landlord may, after written notice to Tenant and Tenant's failure to cure within thirty (30) days of its receipt of such notice, at Landlord's option, perform any and all of Tenant's obligations as aforesaid and all reasonable costs and expenses incurred by Landlord in the exercise of this right shall be deemed to be Additional Rent payable on demand and with interest at the Default Rate until payment at the rate provided in this Lease. (ii) The parties acknowledge and agree that Tenant shall not be held responsible for any environmental issue or violation of applicable Environmental Law at the Premises unless such issue was caused by an action or omission of Tenant or its agents, employees, consultants or invitees. (iii) This Article 10 shall survive the expiration or sooner termination of this Lease. 11. TENANT'S ALTERATIONS. (a) Except as otherwise provided in this subsection (a), Tenant will not cut or drill into or secure any fixture, apparatus or equipment or make alterations, improvements or physical additions (collectively, "Alterations") of any kind to any part of the Premises without first obtaining the written consent of Landlord, such consent not to be unreasonably withheld. Landlord's consent shall not be required with regard to those alterations that, in the aggregate, cost less than $50,000.00 for each calendar year during the Term or any renewal term of this Lease, provided said alterations are non-structural in nature, do not affect the structural integrity of the Building, do not in any material respect affect the cosmetic style of the Building and do not -15- adversely affect any utility systems or other building systems in or for the Building. In addition, Landlord's consent shall not be required for the installation of any office equipment or fixtures including internal partitions which do not require disturbance of any structural elements or systems (other than attachment thereto) within the Building. Tenant shall be required to furnish to Landlord a full set of proposed plans and specifications for the Alterations. If Landlord approves Tenant's Alterations for which such approval is required and agrees to permit Tenant's contractors to do the work, Tenant, prior to the commencement of labor or supply of any materials, must furnish to Landlord (i) a duplicate or original policy or certificates of insurance evidencing (a) general public liability insurance for personal injury and property damage in the minimum amount of $1,000,000.00 combined single limit, (b) statutory workman's compensation insurance, and (c) employer's liability insurance from each contractor to be employed (all such policies shall be non-cancelable without thirty (30) days prior written notice to Landlord; (ii) construction documents prepared and sealed by a registered Pennsylvania architect if such alteration is in excess of $15,000; (iii) all applicable building permits required by law; and (iv) an executed, effective Waiver of Mechanics Liens from such contractors and all sub-contractors. Any consent by Landlord permitting Tenant to do any or cause any work to be done in or about the Premises shall be and hereby is conditioned upon Tenant's work being performed by workmen and mechanics working in harmony and not interfering with labor employed by Landlord, Landlord's mechanics or their contractors or by any other tenant or their contractors. If at any time any of the workmen or mechanics performing any of Tenant's work shall be unable to work in harmony or shall interfere with any labor employed by Landlord, other tenants or their respective mechanics and contractors, then the permission granted by Landlord to Tenant permitting Tenant to do or cause any work to be done in or about the Premises, may be withdrawn by Landlord upon forty-eight (48) hours written notice to Tenant. Tenant shall be deemed to own all Alterations that are not deemed to be fixtures subject to the provisions of this Section 11; provided, however, that Landlord and Tenant agree that the Trade Fixtures of Tenant (as hereinafter defined) shall not be deemed to be fixtures for purposes of this Section 11. The term "Trade Fixtures", for purposes of this Section 11, shall be comprised of the furniture, fixtures and equipment utilized by Tenant in connection with its business operations and shall include items such as, but not limited to, freezers, ovens, autoclaves and other equipment that would not be deemed to be fixtures except for the fact that said items are hooked or bolted or otherwise affixed onto existing fixtures of the Building. At the expiration or sooner termination of this Lease, Tenant shall be required to remove, at its sole cost an expense, all Trade Fixtures in a good and workmanlike manner so as not to damage the Premises or Building. Tenant shall be responsible for the repair of any damage caused by the removal of the Trade Fixtures and shall be required, at its sole cost and expense, to restore any areas affected by this Section 11(a) to a "vanilla shell" condition. (b) Not earlier than nine (9) months and not later than six (6) months prior to the expiration of the Term or the Renewal Term of this Lease, Tenant shall furnish to Landlord a written list of those items that Tenant desires to remove from the Building upon said expiration. The Landlord shall, within thirty (30) days of the receipt of said notification from Tenant, determine, in its sole and exclusive discretion, and provide to Tenant a written list and/or -16- category of items (i) that Tenant shall be required to remove from the Building in order to return the Building to a "vanilla shell" condition for generic industrial space, and (ii) that Landlord agrees may be left in the Building by Tenant. Tenant shall be permitted to remove those items, as determined by Landlord in its reasonable judgement, that do not affect its obligation to return the Building to a "vanilla shell" condition for generic industrial space. In the event of any disagreement between the Landlord and the Tenant with regard to any item set forth in this Section 11(b), said item shall be required to be removed by Tenant unless said item is an item that Landlord requires remain in the Building as part of the "vanilla shell." Subject to the provisions of this Section 11(b), all items left on the Premises by Tenant shall be the Landlord's property and shall remain on the Premises without compensation to Tenant. Any installations, removals and restoration by Tenant shall be in accordance with this Section 11(b) and shall be accomplished at Tenant's sole cost and expense in a good and workmanlike manner so as not to damage the Premises or Building. Tenant shall be responsible for the repair of any damage caused by such installation, removal and restoration and shall be required, at its sole cost and expense, to restore any areas affected by this Section 11(b) to a "vanilla shell" condition. (c) If Tenant fails to remove any items required to be removed pursuant to Section 11(a) or 11(b) hereof no later than the date of the expiration or earlier termination of this Lease, Landlord may do so and the reasonable costs and expenses thereof shall be deemed Additional Rent hereunder and shall be reimbursed by Tenant to Landlord within fifteen (15) business days of Tenant's receipt of an invoice therefor from Landlord. 12. CONSTRUCTION LIENS. (a) Tenant will not voluntarily suffer or permit any contractor's, subcontractor's or supplier's lien (a "Construction Lien") to be filed against the Premises or any part thereof by reason of work, labor services or materials supplied or claimed to have been supplied to Tenant; and if any Construction Lien shall at any time be filed against the Premises or any part thereof, Tenant, within (30) days after notice of the filing thereof, shall cause it to be discharged of record by payment, deposit, bond, order of a court of competent jurisdiction or otherwise. If Tenant shall fail to cause such Construction Lien to be discharged within the period aforesaid, then in addition to any other right or remedy, Landlord may, but shall not be obligated to, discharge it either by paying the amount claimed to be due or by procuring the discharge of such lien by deposit or by bonding proceedings. Any amount so paid by Landlord, plus all of Landlord's reasonable costs and expenses associated therewith (including, without limitation, reasonable legal fees), shall constitute Additional Rent payable by Tenant under this Lease and shall be paid by Tenant to Landlord on demand with interest from the date of advance by Landlord at the Default Rate. (b) Nothing in this Lease, or in any consent to the making of alterations or improvements shall be deemed or construed in any way as constituting authorization by Landlord for the making of any alterations or additions by Tenant within the meaning of 49 P.S. Sections 1101-1902, as amended or under the Contractor and Subcontractor Payment Act or any -17- amendment thereof, or constituting a request by Landlord, express or implied, to any contractor, subcontractor or supplier for the performance of any labor or the furnishing of any materials for the use or benefit of Landlord. 13. ASSIGNMENT AND SUBLETTING. (a) For any assignment and subletting, subject to the remaining subsections of Article 13, except as expressly permitted pursuant to this section, Tenant shall not, without the prior written consent of Landlord, which consent is not to be unreasonably withheld or delayed, assign or hypothecate this Lease or any interest herein or sublet the Premises or any part thereof. Any of the foregoing acts without such consent shall be void and shall, at the option of Landlord, terminate this Lease. Subject to subparagraph 13(i) below, this Lease shall not, nor shall any interest herein, be assignable as to the interest of Tenant by operation of law or by merger, consolidation or asset sale, without the written consent of Landlord. Tenant may assign the subject lease or may sublet the premises or any part thereof, without Landlord's consent after notice, to any subsidiary, parent, affiliate or controlled corporation which is owed at least 50% by Tenant, or to any corporation to which Tenant may be converted or with which it may merge with Tenant as survivor, or who acquires substantially all of Tenant's stock or assets provided that as to asset acquisitions, (A) the financial condition of the proposed assignee or sublessee is at least equal to the financial condition of the Tenant as of the date of this Lease, as determined by Landlord in its reasonable judgement, and (B) the prospective assignee and the Tenant enter into an Assignment and Assumption Agreement with Landlord in form and substance satisfactory to Landlord and its legal counsel, providing, INTER ALIA, that the Tenant shall remain bound to Landlord under the Lease. For any other subletting, Landlord agrees that it will not unreasonably withhold, condition or delay its consent. (b) If at any time or from time to time during the term of this Lease Tenant desires to assign this Lease or sublet all or any part of the Premises, Tenant shall give notice to Landlord of such desire, including the name, address and contact party for the proposed assignee or subtenant, a description of such party's business history, the effective date of the proposed assignment of sublease (including the proposed occupancy date by the proposed assignee or sublessee), and in the instance of a proposed sublease, the square footage to be subleased, a floor plan professionally drawn to scale, depicting the proposed sublease area, and a statement of the duration of the proposed sublease (which shall in any and all events expire by its terms prior to the scheduled expiration of this Lease, and immediately upon the sooner termination hereof). Landlord may, at its option, and in its sole and absolute discretion, exercisable by notice given to Tenant ("Landlord's Election Notice") within forty-five (45) days next following Landlord's receipt of Tenant's notice (which notice from Tenant shall, as a condition of its effectiveness, include all of the above-enumerated information), elect to recapture the Premises or such portion as is proposed by Tenant to be sublet (and in each case, the designated and non-designated parking spaces included in this demise, or a pro-rata portion thereof in the instance of the recapture of less than all of the Premises), and terminate this Lease in the instance of a proposed assignment, or recapture that portion of the Premises proposed to be sublet (and a pro-rata -18- portion of designated and non-designated parking spaces, as aforesaid) and terminate the Lease with respect thereto, in the instance of a proposed sublease; provided, however, that in the event that the Landlord elects to recapture the Premises or such portion as is proposed by Tenant to be sublet, Tenant shall be permitted to withdraw its request for an assignment or sublease by furnishing written notice thereof to Landlord within five (5) days of the date of the Landlord's Election Notice. The Landlord, if it so elects, as an alternative to its option to recapture the Premises or such portion as is proposed by Tenant to be sublet, shall have the right to allow said assignment or sublease and, in said instance, Landlord shall be entitled to retain one hundred percent (100%) of any additional payments (over and above the Rent and Additional Rent payable under this Lease) received by Tenant from said assignee or sublessee in connection with the assignment or sublease of all or part of the Premises after Tenant's recovery of those reasonable costs and expenses incurred directly in connection therewith. Notwithstanding the language contained in this subsection (b), the Tenant shall have the one time right to sublease up to 5,000 square feet of space in the Premises, subject to the Landlord's approval in accordance with Section 13(a) hereof, without the Landlord having the right to recapture said space provided that said sublease is to one single sublessee for a one time sublease right only. In the event that the sublease is for more than 5,000 square feet, or in the event that the sublease is not the first sublease request under this Section 13, then Landlord shall have all of the recapture rights set forth in this subsection (b). NOTWITHSTANDING THE LANGUAGE CONTAINED IN THIS SECTION 14(b), THE TENANT SHALL HAVE THE RIGHT TO SUBLEASE ONE HUNDRED PERCENT (100%) OF THE PREMISES FROM TIME TO TIME WITHOUT TRIGGERING THE RIGHT OF THE LANDLORD TO RECAPTURE THE PREMISES UNDER THIS SECTION 13(b) PROVIDED THAT (i) ALL OF THE OTHER TERMS AND CONDITIONS SET FORTH IN THIS SECTION 13 AND THIS LEASE ARE MADE SUBJECT TO SAID SUBLEASE, AND (ii) LANDLORD RECEIVES ONE HUNDRED PERCENT (100%) OF THE EXCESS RENT RECEIVED BY TENANT FROM SAID SUBLESSEE (WITH NO DEDUCTION OF ANY COSTS OR EXPENSES INCURRED BY TENANT IN CONNECTION THEREWITH), AND (iii) LANDLORD SHALL HAVE THE FULL RIGHT TO RECAPTURE THE PREMISES IN THE EVENT THAT SAID PROPOSED SUBLEASE WOULD OCCUR WITHIN THE LAST THREE (3) YEARS OF THE ORIGINAL TERM OF THIS LEASE OR THE LAST EIGHTEEN (18) MONTHS OF ANY RENEWAL OPTION UNDER THIS LEASE. (c) If Landlord elects to recapture the Premises or a portion thereof as aforesaid, then from and after the effective date thereof as approved by Landlord, after Tenant shall have fully performed such obligations as are enumerated herein to be performed by Tenant in connection with such recapture, and except as to obligations and liabilities accrued and unperformed (and any other obligations expressly stated in this Lease to survive the expiration or sooner termination of this Lease), Tenant shall be released of and from all lease obligations thereafter otherwise accruing with respect to the Premises (or such lesser portion as shall have been recaptured by Landlord). The Premises, or such portion thereof as Landlord shall have elected to recapture, shall be delivered by Tenant to Landlord free and clear of all furniture, furnishings, personal property and removable fixtures, with Tenant repairing and restoring any and all damage to the Premises resulting from the installation, handling or removal thereof, and otherwise in the same condition as Tenant is, by the terms of this Lease, required to redeliver the Premises to Landlord upon the expiration or sooner termination of this Lease. The cost of erecting any required demising walls, entrances and entrance corridors, and any other or further -19- improvements required in connection therewith, including without limitation, modifications to HVAC, electrical, plumbing, fire, life safety and security systems (if any), painting, wallpapering and other finish items as may be acceptable to or specified by Landlord, all of which improvements shall be made in accordance with applicable code requirements and Landlord's then-standard base building specifications, shall be performed by Landlord's contractors, at Tenant's sole cost and expense. Upon the completion of any recapture and termination as provided herein, Tenant's remaining Fixed Rent, Operating Expense and remaining monetary obligations of Tenant shall be adjusted pro-rated based upon the reduced rentable square footage then comprising the Premises. (d) If Landlord provides written notification to Tenant electing not to recapture the Premises (or so much thereof as Tenant had proposed to sublease), then Tenant may proceed to market the designated space and may complete such transaction and execute an assignment of this Lease or a sublease agreement (in each case in form acceptable to Landlord) within a period of five (5) months next following Landlord's notice to Tenant that it declines to recapture such space, provided that Tenant shall have first obtained in any such case the prior written consent of Landlord to such transaction, which consent shall not be unreasonably withheld. If, however, Tenant shall not have assigned this Lease or sublet the Premises with Landlord's prior written consent as aforesaid within five (5) months next following Landlord's notice to Tenant that Landlord declines to recapture the Premises (or such portion thereof as Tenant initially sought to sublease), then in such event, Tenant shall again be required to request Landlord's consent to the proposed transaction, whereupon Landlord's right to recapture the Premises (or such portion as Tenant shall desire to sublease) shall be renewed upon the same terms and as otherwise provided in subsection (b) above. For purposes of this Section 13(d), and without limiting the basis upon which Landlord may withhold its consent to any proposed assignment or sublease, the parties agree that it shall not be unreasonable for Landlord to withhold its consent to such assignment or sublease if: (i) the proposed assignee or sublessee shall have a net worth less than the net worth of Tenant at the time Tenant executes this Lease, or which is otherwise not acceptable to Landlord in Landlord's reasonable discretion; (ii) the proposed assignee or sublessee shall have no reliable credit history or an unfavorable credit history, or other reasonable evidence exists that the proposed assignee or sublessee will experience difficulty in satisfying its financial or other obligations under this Lease; (iii) the proposed assignee or sublessee, in Landlord's reasonable opinion, is not reputable and of good character; (iv) the portion of the Premises requested to be subleased renders the balance of the Premises unleasable as a separate area; (v) Tenant is proposing a sublease at a rental or subrental rate which is substantially less than the then fair market rental rate for the portion of the Premises being subleased or assigned, or Tenant is proposing to assign or sublease to an existing tenant of the Building or another property owned by Landlord or by its partners, or to another prospect with whom Landlord or its partners, or their affiliates are then negotiating; (vi) the proposed assignee or sublessee will cause Landlord's existing parking facilities to be reasonably inadequate, or in violation of code requirements, or require Landlord to increase the parking area or the number of parking spaces to meet code -20- requirements, or the nature of such party's business shall reasonably require more than four (4) parking spaces per per 1,000 rentable square feet of floor space, or (vii) the nature of such party's proposed business operation would or might reasonably permit or require the use of the Premises in a manner inconsistent with the "Permitted Use" specified herein, would or might reasonably otherwise be in conflict with express provisions of this Lease, would or might reasonably violate the terms of any other lease for the Building, or would, in Landlord's reasonable judgement, otherwise be incompatible with other tenancies in the Building. (e) Any sums or other economic consideration received by Tenant as a result of any subletting, assignment or license (except rental or other payments received which are attributable to the amortization of the cost of leasehold improvements made to the sublet or assigned portion of the premises by Tenant for subtenant or assignee, and other reasonable expenses incident to the subletting or assignment, including standard leasing commissions) whether denominated rentals under the sublease or otherwise, which exceed, in the aggregate, the total sums which Tenant is obligated to pay Landlord under this Lease (prorated to reflect obligations allocable to that portion of the premises subject to such sublease or assignment) shall be paid fifty (50) percent to Landlord in their entirety without affecting or reducing any other obligation of Tenant hereunder. (f) Regardless of Landlord's consent, no subletting or assignment shall release Tenant of Tenant's obligation or alter the primary liability of Tenant to pay the Rent and to perform all other obligations to be performed by Tenant hereunder. Consent to one assignment or subletting shall not be deemed consent to any subsequent assignment or subletting. (g) In the event that (i) the Premises or any part thereof are sublet and Tenant is in default under this Lease, or (ii) this Lease is assigned by Tenant, then, Landlord may collect Rent from the assignee or subtenant and apply the net amount collected to the rent herein reserved; but no such collection shall be deemed a waiver of the provisions of this Article 13 with respect to assignment and subletting, or the acceptance of such assignee or subtenant as Tenant hereunder, or a release of Tenant from further performance of the covenants herein contained. (h) In connection with each proposed assignment or subletting of the Premises by Tenant, Tenant shall pay to Landlord Landlord's reasonable attorneys' fees in an amount not to exceed $750.00. (i) Notwithstanding anything to the contrary contained herein, regardless of whether Landlord shall consent thereto (or whether such transaction shall otherwise be permitted hereunder upon notice to, but without the consent of Landlord), no assignment of this Lease and no subletting of the Premises or any portion thereof shall release Tenant of Tenant's obligations hereunder, or alter the primary liability of Tenant to pay the Rent and to perform any and all other obligations to be performed by the holder of the tenant interest hereunder, and it shall be an express condition of any assignment or sublease that a fully-executed, original -21- counterpart of the assignment or sublease agreement, in form specified by or otherwise acceptable to Landlord, shall be furnished to Landlord prior to the effective date thereof. Any assignment document shall, among its terms, contain an express agreement by the assignee to assume and be bound by all of the obligations to be performed and discharged by the holder of the tenant interest hereunder, and shall include an affirmation by the assignor of its continuing primary liability hereunder notwithstanding such assignment. Any sublease document shall, among its terms, be expressly subject and subordinate in all respects to this Lease, and the shall contain an affirmation by the sublessor of its continuing primary liability hereunder notwithstanding such sublease. The acceptance of rental by Landlord from any other person shall not be deemed to be a waiver by Landlord of any provision hereof. Consent to one assignment or subletting shall not be deemed consent to any subsequent assignment or subletting. In the event of default by any assignee of Tenant or any successor of Tenant in the performance of any of the terms hereof, Landlord may proceed directly against Tenant without the necessity of exhausting remedies against such assignee or successor. (j) Anything in this Article 13 to the contrary notwithstanding (including, without limitation, any provisions herein regarding permitted assignments or subleases) no assignment or sublease shall be permitted under this Lease if, at the time Tenant seeks approval therefor, or at any time thereafter until such assignment or sublease becomes effective and shall be implemented, Tenant is in default beyond applicable cure periods of any of its obligations under this Lease. 14. LANDLORD'S RIGHT OF ENTRY. Subject to the provisions of Section 38(T) hereof, Landlord and persons authorized by Landlord may enter the Premises at all reasonable times upon not less than forty-eight (48) hours notice (except in the case of an emergency in which case no prior notice is necessary) for the purpose of inspections, repairs, alterations to adjoining space, appraisals, or other reasonable purposes; including enforcement of Landlord's rights under this Lease. Landlord shall not be liable for inconvenience to or disturbance of Tenant by reason of any such entry other than resulting from the negligence or intentional misconduct of Landlord or its agents; provided, however, that in the case of repairs or work, such shall be done, so far as practicable, so as to not unreasonably interfere with Tenant's use of the Premises. Provided, however, that such efforts shall not require Landlord to use overtime labor unless Tenant shall pay for the increased costs to be incurred by Landlord for such overtime labor. Landlord also shall have the right to enter the Premises at all reasonable times after giving not less than three (3) days prior notice to Tenant, to exhibit the Premises to any prospective purchaser, tenant and/or mortgagee. -22- 15. REPAIRS AND MAINTENANCE. (a) Except as specifically otherwise provided in subparagraphs (b) and (c) of this Article, Tenant, at its sole cost and expense and throughout the Term (as may be extended) of this Lease, shall keep and maintain the Premises in good order and condition, free of accumulation of dirt and rubbish, and shall promptly make all repairs other than repairs to the footings and foundations and the structural steel columns and girders forming a part of the Premises necessary to keep and maintain such good order and condition. Tenant shall have the option of replacing lights, ballasts, tubes, ceiling tiles, outlets and similar equipment itself or it shall have the ability to advise Landlord of Tenant's desire to have Landlord make such repairs. If requested by Tenant, Landlord shall make such repairs to the Premises with a reasonable time of notice to Landlord and shall charge Tenant for such services at Landlord's standard rate (such rate to be competitive with the market rate for such services). Tenant shall not use or permit the use of any portion of the Premises for outdoor storage except for exterior chemical storage in connection with Tenant's business operations at the Premises, provided that (i) the proposed storage area is designated on the plans to be provided in advance to the Landlord for its approval, (ii) Tenant has received, at its sole cost and expense, all federal, state and local permits, approvals and authorizations for the utilization of said storage area, (iii) the installation, use and operation of the storage area complies with all federal, state and local environmental and other laws, rules and regulations, and (iv) in the event that said storage area utilizes an area that would otherwise constitute one or more parking spaces in the Parking Area, the parking space or spaces utilized for storage area shall be counted in the number of parking spaces that Landlord is required to furnish to Tenant hereunder. Tenant shall be permitted to utilize the area that the previous tenant in the Premises utilized as a storage area provided, however, that Tenant hereby acknowledges that Landlord makes no representations, warranties or covenants regarding whether appropriate federal, state and local permits, approvals, and authorizations were previously obtained in connection with said storage area. When used in this Article 15, the term "repairs" shall include replacements and renewals when necessary. All repairs made by Tenant shall utilize materials and equipment which are at least equal in quality and usefulness to those originally used in constructing the Building and the Premises. Tenant shall maintain all HVAC systems serving the Building and the Premises. (b) Landlord, throughout the Term of this Lease and at Landlord's sole cost and expenses, shall make all necessary repairs to the footings and foundations and the structural steel columns and girders forming a part of the Premises. Landlord shall also be responsible, at its sole cost and expense, for correcting any violations of, or as may be necessary to comply with, all municipal, county, state and federal governmental laws, codes and requirements and repairs required to correct latent defects in the Building, subject to the other provisions of this Lease. This requirement does not apply if Tenant's equipment or use of the Premises is the cause for such repair, in which event it shall be Tenant's responsibility at its sole cost and expense to correct said violations. -23- (c) Landlord, throughout the Term of this Lease, shall make all necessary repairs to the Building outside of the Premises and the common areas, including the roof, walls, exterior portions of the Premises and the Building, utility lines, equipment and other utility facilities in the Building, which serve more than one tenant of the Building, and to any driveways, sidewalks, curbs, loading, parking and landscaped areas, and other exterior improvements for the Building; provided, however, that Landlord shall have no responsibility to make any repairs unless and until Landlord receives written notice of the need for such repair. Tenant shall pay its Allocated Share of the cost of all repairs to be performed by Landlord pursuant to this Paragraph 15(c) as Additional Rent as provided, in Article 6 hereof. Tenant will receive a total of one hundred (100) parking spaces for the subject building at no cost to the Tenant, during the entire lease term and any extensions thereof, to be designated for Tenant's sole and exclusive use. Said parking will be located immediately adjacent to the subject building. (d) Landlord shall keep and maintain all common areas appurtenant to the Building and any sidewalks, parking areas, curbs and access ways adjoining the Property in a clean and orderly condition, free of accumulation of dirt, rubbish, snow and ice, and shall keep and maintain all landscaped areas in a neat and orderly condition. Tenant shall pay its Allocated Share of the cost of all work to be performed by Landlord pursuant to this Paragraph (d) as Additional Rent as provided in Article 6 hereof. (e) Notwithstanding anything herein to the contrary, repairs to the Premises, Building or Project and its appurtenant common areas made necessary by a negligent or wilful act or omission of Tenant or any employee, agent, contractor, or invitee of Tenant which are not covered by insurance required to be maintained under this Lease shall be made at the sole cost and expense of Tenant. 16. INSURANCE; SUBROGATION RIGHTS. (a) Tenant shall obtain and keep in force at all times during the term hereof, at its own expense, comprehensive general liability insurance including contractual liability and personal injury liability and all similar coverage, with combined single limits of $3,000,000.00 on account of bodily injury to or death of one or more persons as the result of any one accident or disaster and on account of damage to property, or in such other amounts as Landlord may from time to time require. The policy limits set forth herein shall be subject to periodic review, and Landlord reserves the right to require that Tenant increase the liability coverage limits if, in the reasonable opinion of Landlord, the coverage becomes inadequate and is less than commonly maintained by tenants of similar buildings in the area making similar uses. (b) Tenant shall, at its sole cost and expense, maintain in full force and effect on all Tenant's trade fixtures, equipment and personal property on the Premises, a policy of all risk property insurance covering the full replacement value of such property. -24- (c) All insurance required hereunder shall not be subject to cancellation without at least thirty (30) days prior notice to all insureds, and shall name Landlord, Brandywine Realty Trust, Landlord's Agent and Tenant as insureds, as their interests may appear, and, if requested by Landlord, shall also name as an additional insured any mortgagee or holder of any mortgage which may be or become a lien upon any part of the Premises. Prior to the commencement of the Term, Tenant shall provide Landlord with certificates and copies of the policy or policies of insurance above referred to, with evidence that the coverages required have been obtained and that premiums have been paid in full for the policy periods. Tenant shall also furnish to Landlord throughout the term hereof replacement certificates or copies of renewal policies, together with evidence of like paid premiums at least thirty (30) days prior to the expiration dates of the then current policy or policies. All the insurance required under this Lease shall be issued by insurance companies authorized to do business in the Commonwealth of Pennsylvania with a financial rating of at least an A-X as rated in the most recent edition of Best's Insurance Reports and in business for the past five years. The limit of any such insurance shall not limit the liability of Tenant hereunder. If Tenant fails to procure and maintain such insurance, Landlord may, but shall not be required to, procure and maintain the same, at Tenant's expense to be reimbursed by Tenant as Additional Rent within ten (10) days of written demand. Any deductible under such insurance policy or self-insured retention under such insurance policy in excess of Twenty Five Thousand Dollars ($25,000.00) for products liability insurance and Five Thousand Dollars ($5,000.00) for all other insurance coverages must be approved by Landlord in writing prior to issuance of such policy. Tenant shall not self-insure without Landlord's prior written consent, which consent may be withheld by Landlord in its sole, exclusive discretion. The policy limits set forth herein shall be subject to periodic review, and Landlord reserves the right to require that Tenant increase the liability coverage limits if, in the reasonable opinion of Landlord, the coverage becomes inadequate and is less than commonly maintained by tenants of similar buildings in the area making similar uses. (d) Landlord shall obtain and maintain the following insurance during the Term of this Lease: (i) replacement cost insurance including all risk perils on the Building and on the Project, (ii) builder's risk insurance for the Landlord Work to be constructed by Landlord in the Project, and (iii) comprehensive liability insurance (including bodily injury and property damage) covering Landlord's operations at the Project in amounts reasonably required by the Landlord's lender or Landlord. (e) Each party hereto, and anyone claiming through or under them by way of subrogation, waives and releases any cause of action it might have against the other party, including Tenant and Brandywine Realty Trust and their respective employees, officers, members, partners, trustees and agents, on account of any loss or damage that is insured against under any insurance policy required to be obtained hereunder (to the extent that such loss or damage is recoverable under such insurance policy) that covers the Project, Building or Premises, Landlord's or Tenant's fixtures, personal property, leasehold improvements or business and which names Landlord and Brandywine Realty Trust or Tenant, as the case may be, as a party insured. Each party hereto agrees that it will cause its insurance carrier to endorse all applicable policies -25- waiving the carrier's right to recovery under subrogation or otherwise against the other party. During any period while such waiver of right of recovery is in effect, each party shall look solely to the proceeds of such policies for compensation for loss, to the extent such proceeds are paid under such policies. 17. INDEMNIFICATION. Except for any acts of Landlord's willful misconduct or negligent acts, Tenant shall defend, indemnify and hold harmless Landlord, Brandywine Realty Services Corp. and Brandywine Realty Trust and their respective employees and agents from and against any and all third-party claims, actions, damages, liability and expense (including all attorney's fees, expenses and liabilities incurred in defense of any such claim or any action or proceeding brought thereon) arising from (i) Tenant's use of the Premises in violation of the terms of this Lease, (ii) the improper conduct of Tenant's business in violation of this Lease, (iii) any activity, work or things done, permitted or suffered by Tenant in or about the Premises or elsewhere contrary to the requirements of the Lease, (iv) any breach or default in the performance of any obligation of Tenant's part to be performed under the terms of this Lease, and (v) any negligence or willful act of Tenant or any of Tenant's agents, contractors or employees and/or negligence or other tortious acts of third-parties not covered by insurance policies required to be maintained under this Lease, and in case Landlord, Brandywine Realty Services Corp. or Brandywine Realty Trust shall be made a party to any litigation commenced by or against Tenant, its agents, subtenants, licensees, concessionaires, contractors, customers or employees, then Tenant shall defend, indemnify and hold harmless Landlord, Brandywine Realty Services Corp. and Brandywine Realty Trust and shall pay all costs, expenses and reasonable attorney's fees incurred or paid by Landlord, Brandywine Realty Services Corp. and Brandywine Realty Trust in connection with such litigation, after notice to Tenant and Tenant's refusal to defend such litigation, and upon notice from Landlord shall defend the same at Tenant's expense by counsel satisfactory to Landlord. Tenant shall further indemnify and hold harmless Landlord, Brandywine Realty Services Corp. and Brandywine Realty Trust from and against any and all third-party claims, actions, damages, liability and expense (including, without limitation, reasonable attorney's fees and disbursements) which may be imposed upon or incurred by or asserted against Landlord by reason of (a) loss of life, personal injury and/or damage to property occurring in or about, or arising out of, the Premises, adjacent sidewalks and loading platforms or areas and common areas appurtenant to the Building occasioned by any act or omission of Tenant, its agents, subtenants, licensees, concessionaires, contractors, customers, employees and/or third party and (b) any failure on the part of Tenant to keep, observe and perform any of the terms, covenants, agreements, conditions, limitations or Rules and Regulations contained in this Lease on Tenant's part to be kept, observed and performed. The indemnification set forth in this Section 17 shall not apply in a legal action commenced by Tenant against Landlord for breach by Landlord of its obligations under this Lease; provided, however, that said indemnification shall be applicable in the event a counterclaim is filed by Landlord with respect to said legal action that pertains to a subject matter that is covered by the indemnification set forth in this Section 17. -26- 18. QUIET ENJOYMENT. Provided Tenant has performed all of the terms and conditions of this Lease, including the payment of Fixed Rent and Additional Rent, to be performed by Tenant, Tenant shall peaceably and quietly hold and enjoy the Premises for the Term, without hindrance from Landlord, or anyone claiming by through or under Landlord under and subject to the terms and conditions of this lease and of any mortgages now or hereafter affecting all of or any portion of the Premises. 19. FIRE DAMAGE AND OTHER CASUALTIES. (a) Except as provided below, in case of damage to the Premises by fire or other insured casualty, Landlord shall repair the damage. Such repair work shall be commenced promptly following notice of the damage and completed with due diligence, taking into account the time required for Landlord to effect a settlement with and procure insurance proceeds from the insurer, except for delays due to governmental regulation, scarcity of or inability to obtain labor or materials, intervening acts of God or other causes beyond Landlord's reasonable control. (b) Notwithstanding the foregoing, if (i) the damage is of a nature or extent that, in Landlord's reasonable judgment (to be communicated to the other within sixty (60) days from the date of the casualty), the repair and restoration work would require more than one hundred eighty (180) consecutive days to complete after the casualty and, assuming normal work crews not engaged in overtime, or (ii) if more than thirty (30%) percent of the total area of the Building is extensively damaged, Landlord and Tenant each shall have the right to terminate this Lease and all the unaccrued obligations of the parties hereto, by sending written notice of such termination to the other within ten (10) days of receipt of the notice described above. Such notice is to specify a termination date no less than fifteen (15) days after its transmission; provided, however, that in addition to the foregoing, in the event Tenant shall have also vacated the Premises because the nature or extent of the damage rendered the Premises untenantable, Tenant may by notice in writing to Landlord within five (5) days of receipt of Landlord's written notice elect to make the termination of the Lease retroactive to the date of such vacation of the Premises by Tenant. Notwithstanding the foregoing, in the event Tenant is responsible for the aforesaid casualty, Tenant shall NOT have the right to terminate this Lease if Landlord is willing to rebuild and restore the Premises. (c) If the insurance proceeds received by Landlord as dictated by the terms and conditions of any financing then existing on the Building, (excluding any rent insurance proceeds) would not be sufficient to pay for repairing the damage or are required to be applied on account of any mortgage which encumbers any part of the Premises or Building, or if the nature of loss is not covered by Landlord's fire insurance coverage, Landlord may elect either to (i) repair the damage as above provided notwithstanding such fact or (ii) terminate this Lease by giving Tenant notice of Landlord's election within thirty (30) days after Landlord's knowledge of the damage and of the unavailability or insufficiency of insurance proceeds. If the election is to terminate, Landlord shall give Tenant at least thirty (30) days prior notice specifying the termination date. -27- (d) In the event Landlord has not completed restoration of the Premises within one hundred eighty (180) days from the date of casualty (subject to delay due to weather conditions, shortages of labor or materials or other reasons beyond Landlord's control which delay in any event will not exceed an additional thirty (30) business days), Tenant may terminate this Lease by written notice to Landlord within thirty (30) business days following the expiration of such 180 day period (as extended for reasons beyond Landlord's control as provided above) unless, within thirty (30) business days following receipt of such notice, Landlord has substantially completed such restoration and delivered the Premises to Tenant for occupancy. (e) In the event of damage or destruction to the Premises or any part thereof, Tenant's obligation to pay Fixed Rent and Additional Rent shall be equitably adjusted or abated, provided the deduction or abatement of Rent shall not exceed rent insurance proceeds received by Landlord attributable to the Premises for the period during which it was damaged. Notwithstanding the foregoing, there shall be no abatement in Rent or Additional Rent if Tenant caused or is responsible for the casualty such that insurance proceeds are unavailable therefor. 20. SUBORDINATION; RIGHTS OF MORTGAGEE. (a) This Lease shall be subject and subordinate to the lien of any mortgages now or hereafter placed upon the Premises, Building and/or Project and land of which they are a part without the necessity of any further instrument or act on the part of Tenant to effectuate such subordination. Tenant further agrees to execute and deliver upon demand such further instrument or instruments evidencing such subordination of this Lease to the lien of any such mortgage and such commercially reasonable further instrument or instruments of attornment as shall be desired by any mortgagee or proposed mortgagee or by any other person provided Tenant receives a standard form of Nondisturbance Agreement (defined below) from such mortgagee. Notwithstanding the foregoing, any mortgagee may at any time subordinate its mortgage to this Lease, without Tenant's consent, by notice in writing to Tenant, and thereupon this Lease shall be deemed prior to such mortgage without regard to their respective dates of execution and delivery and in that event such mortgagee shall have the same rights with respect to this Lease as though it had been executed prior to the execution and delivery of the mortgage. (b) In the event Landlord shall be or is alleged to be in default of any of its obligations owing to Tenant under this Lease, Tenant agrees to give to the holder of any mortgage (collectively the "Mortgagee") now or hereafter placed upon the Premises, Building and/or Project, notice by registered mail of any such default which Tenant shall have served upon Landlord, provided that prior thereto Tenant has been notified in writing (by way of Notice of Assignment of Rents and/or Leases or otherwise in writing to Tenant) of the name and addresses of any such Mortgagee. Tenant shall not be entitled to exercise any right or remedy as there may be because of any default by Landlord without having given such notice to the Mortgagee; and Tenant further agrees that if Landlord shall fail to cure such default the Mortgagee shall have any additional time periods (measured from the later of the date on which the default should have been cured by Landlord or the Mortgagee's receipt of such notice from Tenant), within which to -28- cure such default, provided that if such default be such that the same could not be cured within such period and Mortgagee is diligently pursuing the remedies necessary to effectuate the cure (including but not limited to foreclosure proceedings if necessary to effectuate the cure); then Tenant may not exercise any right or remedy as there may be arising because of Landlord's default, including but not limited to, termination of this Lease as may be expressly provided for herein or available to Tenant as a matter of law, if the Mortgagee either has cured the default within such time periods, or as the case may be, has initiated the cure of same within such period and is diligently pursuing the cure of same as aforesaid. (c) Attached to this Lease as Exhibit F is a form of Subordination, Attornment and Non-Disturbance Agreement ("Non-Disturbance Agreement") that is hereby deemed to be acceptable in form and substance to each of Landlord and Tenant. Landlord and Tenant hereby each agree that upon request of the existing or a future mortgagee of Landlord, each of Landlord and Tenant shall enter into the Non-Disturbance Agreement or a form of non-disturbance agreement substantially similar to that set forth in Exhibit F. In the event that a future mortgagee shall be unwilling to enter into the Non-Disturbance Agreement as aforesaid, Landlord and Tenant hereby each agrees to utilize their best efforts in good faith to agree to the form of a new non-disturbance agreement with said future mortgage. In the event that Landlord, Tenant and said future mortgagee are unable to agree upon the terms of a new non-disturbance agreement, this Lease shall remain in full force and effect and the obligations of Tenant shall not in any manner be affected except that, anything to the contrary contained in this Lease notwithstanding, this Lease shall not be subject and subordinate to such future mortgage. Tenant shall be obligated to enter into a new non-disturbance agreement provided that its terms are materially similar in substance to the Non-Disturbance Agreement. 21. CONDEMNATION. (a) If more than twenty (20%) percent of the floor area of the Premises is taken or condemned for a public or quasi-public use (a sale in lieu of condemnation to be deemed a taking or condemnation for purposes of this Lease), this Lease shall, at either party's option, terminate as of the date title to the condemned real estate vests in the condemnor, and the Fixed Rent and Additional Rent herein reserved shall be apportioned and paid in full by Tenant to Landlord to that date and all rent prepaid for period beyond that date shall forthwith be repaid by Landlord to Tenant. (b) If less than twenty (20%) percent of the floor area of the Premises is taken or if neither Landlord nor Tenant have elected to terminate this Lease pursuant to the preceding sentence, Landlord shall do such work as may be reasonably necessary to restore the portion of the Premises not taken to tenantable condition for Tenant's uses, but shall not be required to expend more than the net award Landlord reasonably expects to be available for restoration of the Premises. If Landlord determines that the damages available for restoration of the Building and/or Project will not be sufficient to pay the cost of restoration, or if the condemnation damage award is required to be applied on account of any mortgage which encumbers any part of the -29- Premises, Building and/or Project, Landlord may terminate this Lease by giving Tenant ninety (90) days prior written notice specifying the termination date. (c) If this Lease is not terminated after any such taking or condemnation, the Fixed Rent and the Additional Rent shall be equitably reduced in proportion to the area of the Premises which has been taken for the balance of the Term. (d) If a part or all of the Premises shall be taken or condemned, all compensation awarded upon such condemnation or taking shall go to Landlord and Tenant shall have no claim thereto other than (i) Tenant's right to bring a claim for the cost of the alterations made by Tenant at Tenant's sole cost and expense, provided that said claim does not in any manner or affect adversely affect any condemnation claim by Landlord, and (ii) Tenant's damages associated with moving, storage and relocation; and Tenant hereby expressly waives, relinquishes and releases to Landlord any claim for damages or other compensation to which Tenant might otherwise be entitled because of any such taking or limitation of the leasehold estate hereby created, and irrevocably assigns and transfers to Landlord any right to compensation of all or a part of the Premises or the leasehold estate. 22. ESTOPPEL CERTIFICATE. Each party agrees at any time and from time to time, within ten (10) days after the other party's written request, to execute, acknowledge and deliver to the other party a written instrument in recordable form certifying that this Lease is unmodified and in full force and effect (or if there have been modifications, that it is in full force and effect as modified and stating the modifications), and the dates to which Rent, Additional Rent, and other charges have been paid in advance, if any, and stating whether or not to the best knowledge of the party signing such certificate, the requesting party is in default in the performance of any covenant, agreement or condition contained in this Lease and, if so, specifying each such default of which the signer may have knowledge. It is intended that any such certification and statement delivered pursuant to this Article may be relied upon by any prospective purchaser of the Project or any mortgagee thereof or any assignee of Landlord's interest in this Lease or of any mortgage upon the fee of the Premises or any part thereof. 23. DEFAULT. If: (i) Tenant shall fail to pay any installment of Fixed Rent or any amount of Additional Rent when due and has failed to remit said repayment within five (5) days of date of written notice thereof from Landlord, provided, however, that in the event that any notice is required to be given by Landlord more than two (2) times in any twelve (12) month period of this Lease or more than ten (10) times during the Term or any renewal term of the Lease, Tenant shall be deemed to be in default under this Lease without the requirement of any notice from Landlord. -30- (ii) Tenant "vacates" the Premises (other than in the case of a permitted subletting or assignment) or permits the same to be unoccupied as defined in Section 9(b) hereof. (iii) Tenant fails to observe or perform any of Tenant's other agreements or obligations herein contained within thirty (30) days after written notice specifying the default, or the expiration of such additional time period as is reasonably necessary to cure such default, provided Tenant immediately commences and thereafter proceeds with all due diligence and in good faith to cure such default, (iv) Tenant makes any assignment for the benefit of creditors, (v) Tenant commits an act of federal or state bankruptcy or files a petition or commences any proceeding under any bankruptcy or insolvency law, (vi) a petition is filed or any proceeding is commenced against Tenant under any federal or state bankruptcy or insolvency law and such petition or proceeding is not dismissed within thirty (30) days, (vii) Tenant is adjudicated a bankrupt, (viii) Tenant by any act indicates its consent to, approval of or acquiescence in, or a court approves, a petition filed or proceeding commenced against Tenant under any federal or state bankruptcy or insolvency law, (ix) a receiver or other official is appointed for Tenant or for a substantial part of Tenant's assets or for Tenant's interests in this Lease, (x) any attachment or execution against a substantial part of Tenant's assets or of Tenant's interests in this Lease remains unstayed or undismissed for a period of more than ten (10) days, (xi) a substantial part of Tenant's assets or of Tenant's interest in this Lease is taken by legal process in any action against Tenant, or (xii) Tenant shall have committed an Event of Default under the terms of that certain Lease, dated even date herewith, by and between Landlord and Tenant with regard to that certain land and premises known as 660 Allendale Road, King of Prussia, Pennsylvania, then, in any such event, an Event of Default shall be deemed to exist and Tenant shall be in default hereunder. If an Event of Default shall occur, the following provisions shall apply and Landlord shall have, in addition to all other rights and remedies available at law or in equity, the rights and -31- remedies set forth therein, which rights and remedies may be exercised upon or at any time following the occurrence of an Event of Default unless, prior to such exercise, Landlord shall agree in writing with Tenant that the Event(s) of Default has been cured by Tenant in all respects. (a) ACCELERATION OF RENT. By notice to Tenant, Landlord shall have the right to accelerate all Fixed Rent and all expense installments due hereunder and otherwise payable in installments over the remainder of the Term, and, at Landlord's option, any other Additional Rent to the extent that such Additional Rent can be determined and calculated to a fixed sum; and the amount of accelerated rent to the termination date, without further notice or demand for payment, shall be due and payable by Tenant within five (5) days after Landlord has so notified Tenant, such amount collected from Tenant pursuant to a judgment shall be discounted to present value using an interest rate of ten percent (10%) per annum. Additional Rent which has not been included, in whole or in part, in accelerated rent, shall be due and payable by Tenant during the remainder of the Term, in the amounts and at the times otherwise provided for in this Lease. Notwithstanding the foregoing or the application of any rule of law based on election of remedies or otherwise, if Tenant fails to pay the accelerated rent in full when due, Landlord thereafter shall have the right by notice to Tenant, (i) to terminate Tenant's further right to possession of the Premises and (ii) to terminate this Lease under subparagraph (b) below; and if Tenant shall have paid part but not all of the accelerated rent, the portion thereof attributable to the period equivalent to the part of the Term remaining after Landlord's termination of possession or termination of this Lease shall be applied by Landlord against Tenant's obligations owing to Landlord, as determined by the applicable provisions of subparagraphs (c) and (d) below. (b) TERMINATION OF LEASE. By notice to Tenant, Landlord shall have the right to terminate this Lease as of a date specified in the notice of termination and in such case, Tenant's rights, including any based on any option to renew, to the possession and use of the Premises shall end absolutely as of the termination date; and this Lease shall also terminate in all respects except for the provisions hereof regarding Landlord's damages and Tenant's liabilities arising prior to, out of and following the Event of Default and the ensuing termination. Following such termination and the notice of same provided above (as well as upon any other termination of this Lease by expiration of the Term or otherwise) Landlord immediately shall have the right to recover possession of the Premises; and to that end, Landlord may enter the Premises and take possession, with the necessity of giving Tenant any notice to quit or any other further notice, with legal process or proceedings, and in so doing Landlord may remove Tenant's property (including any improvements or additions to the Premises which Tenant made, unless made with Landlord's consent which expressly permitted Tenant to not remove the same upon expiration of the Term), as well as the property of others as may be in the Premises, and make disposition thereof in such manner as Landlord may deem to be commercially reasonable and necessary under the circumstances. -32- (c) TENANT'S CONTINUING OBLIGATIONS/LANDLORD'S RELETTING RIGHTS (1) Unless and until Landlord shall have terminated this Lease under subparagraph (b) above, Tenant shall remain fully liable and responsible to perform all of the covenants and to observe all the conditions of this Lease throughout the remainder of the Term to the early termination date; and, in addition, Tenant shall pay to Landlord, upon demand and as Additional Rent, the total sum of all costs, losses and expenses, including reasonable attorneys' fees, as Landlord incurs, directly or indirectly, because of any Event of Default having occurred. (2) If Landlord either terminates Tenant's right to possession without terminating this Lease or terminates this Lease and Tenant's leasehold estate as above provided, then, subject to the provisions below, Landlord shall have the unrestricted right to relet the Premises or any part(s) thereof to such tenant(s) on such provisions and for such period(s) as Landlord may deem appropriate. If Landlord relets the Premises after such a default, the costs recovered from Tenant shall be reallocated to take into consideration any additional rent which Landlord receives from the new tenant which is in excess to that which was owed by Tenant. (d) LANDLORD'S DAMAGES. (1) The damages which Landlord shall be entitled to recover from Tenant shall be the sum of: (A) all Fixed Rent and Additional Rent accrued and unpaid as of the termination date; and (B) (i) all reasonable costs and expenses incurred by Landlord in recovering possession of the Premises, including removal and storage of Tenant's property, in accordance with Section 11 hereof, (ii) the costs and expenses of restoring the Premises to the condition in which the same were to have been surrendered by Tenant as of the expiration of the Term and accordance with Section 11 hereof, and (iii) the costs of reletting commissions; and (C) all Fixed Rent and Additional Rent (to the extent that the amount(s) of Additional Rent has been then determined) otherwise payable by Tenant over the remainder of the Term as reduced to present value. Less deducting from the total determined under subparagraphs (A), (B) and (C) all Rent and all other Additional Rent to the extent determinable as aforesaid, (to the extent that like charges would have been payable by Tenant) which Landlord receives from other tenant(s) by reason of the leasing of the Premises or part during or attributable to any period falling within the otherwise remainder of the Term. (2) The damage sums payable by Tenant under the preceding provisions of this paragraph (d) shall be payable on demand from time to time as the amounts are -33- determined; and if from Landlord's subsequent receipt of rent as aforesaid from reletting, there be any excess payment(s) by Tenant by reason of the crediting of such rent thereafter received, the excess payment(s) shall be refunded by Landlord to Tenant. (3) Landlord may distrain for rent, and enforce the provisions of this Lease and may enforce and protect the rights of Landlord hereunder by a suit or suits in equity or at law for the specific performance of any covenant or agreement contained herein, and for the enforcement of any other appropriate legal or equitable remedy, including, without limitation, injunctive relief, and for recovery of all moneys due or to become due from Tenant under any of the provisions of this Lease. (e) LANDLORD'S RIGHT TO CURE. Without limiting the generality of the foregoing, if Tenant shall be in default in the performance of any of its obligations hereunder, Landlord, without being required to give Tenant any notice or opportunity to cure, may (but shall not be obligated to do so), in addition to any other rights it may have in law or in equity, cure such default on behalf of Tenant, and Tenant shall reimburse Landlord upon demand for any sums paid or costs incurred by Landlord in curing such default, including reasonable attorneys' fees and other legal expenses, together with interest at 10% per annum Rate from the dates of Landlord's incurring of costs or expenses. (f) ADDITIONAL REMEDIES. In addition to, and not in lieu of any of the foregoing rights granted to Landlord: (i) TENANT HEREBY EMPOWERS ANY PROTHONOTARY, CLERK OF COURT OR ATTORNEY OF ANY COURT OF RECORD TO APPEAR FOR TENANT IN ANY AND ALL ACTIONS WHICH MAY BE BROUGHT FOR EVICTION OF THE TENANT FROM THE PREMISES AND FOR POSSESSION OF THE PREMISES BY LANDLORD, AND TO SIGN FOR TENANT AN AGREEMENT FOR ENTERING IN ANY COMPETENT COURT AN ACTION OR ACTIONS FOR EVICTION OR RECOVERY OF SAID POSSESSION, AND IN SAID SUIT OR IN SAID ACTION OR ACTIONS TO CONFESS JUDGEMENT AGAINST TENANT FOR EVICTION AND FOR SUCH POSSESSION. SUCH AUTHORITY SHALL NOT BE EXHAUSTED BY ONE EXERCISE THEREOF, BUT JUDGMENT MAY BE CONFESSED AS AFORESAID FROM TIME TO TIME AS OFTEN AS TENANT SHALL HAVE COMMITTED AN EVENT OF DEFAULT, AND SUCH POWERS MAY BE EXERCISED AS WELL AFTER THE EXPIRATION OF THE TERM OR DURING ANY EXTENSION OR RENEWAL OF THIS LEASE. (g) INTEREST ON DAMAGE AMOUNTS. Any sums payable by Tenant hereunder, which are not paid after the same shall be due, shall bear interest from that day until paid at the rate of four (4%) percent over the then Prime Rate as published daily under the heading "Money Rates" in THE WALL STREET JOURNAL, unless such rate be usurious as applied to Tenant, in which case the highest permitted legal rate shall apply (the "Default Rate"). -34- (h) LANDLORD'S STATUTORY RIGHTS. Landlord shall have all rights and remedies now or hereafter existing at law or in equity with respect to the enforcement of Tenant's obligations hereunder and the recovery of the Premises. No right or remedy herein conferred upon or reserved to Landlord shall be exclusive of any other right or remedy, but shall be cumulative and in addition to all other rights and remedies given hereunder or now or hereafter existing at law. Landlord shall be entitled to injunctive relief in case of the violation, or attempted or threatened violation, of any covenant, agreement, condition or provision of this Lease, or to a decree compelling performance of any covenant, agreement, condition or provision of this Lease. (i) REMEDIES NOT LIMITED. Nothing herein contained shall limit or prejudice the right of Landlord to exercise any or all rights and remedies available to Landlord by reason of default or to prove for and obtain in proceedings under any bankruptcy or insolvency laws, an amount equal to the maximum allowed by any law in effect at the time when, and governing the proceedings in which, the damages are to be proved, whether or not the amount be greater, equal to, or less than the amount of the loss or damage referred to above. (j) NO WAIVER BY LANDLORD. No delay or forbearance by Landlord in exercising any right or remedy hereunder, or Landlord's undertaking or performing any act or matter which is not expressly required to be undertaken by Landlord shall be construed, respectively, to be a waiver of Landlord's rights or to represent any agreement by Landlord to undertake or perform such act or matter thereafter. Waiver by Landlord of any breach by Tenant of any covenant or condition herein contained (which waiver shall be effective only if so expressed in writing by Landlord) or failure by Landlord to exercise any right or remedy in respect of any such breach shall not constitute a waiver or relinquishment for the future of Landlord's right to have any such covenant or condition duly performed or observed by Tenant, or of Landlord's rights arising because of any subsequent breach of any such covenant or condition nor bar any right or remedy of Landlord in respect of such breach or any subsequent breach. Landlord's receipt and acceptance of any payment from Tenant which is tendered not in conformity with the provisions of this Lease or following an Event of Default (regardless of any endorsement or notation on any check or any statement in any letter accompanying any payment) shall not operate as an accord and satisfaction or a waiver of the right of Landlord to recover any payments then owing by Tenant which are not paid in full, or act as a bar to the termination of this Lease and the recovery of the Premises because of Tenant's previous default. 24. CURING TENANT'S DEFAULTS. If Tenant shall default in the performance of any of its non-monetary obligations hereunder, Landlord without prejudice and in addition to any other rights it may have at law or in equity, after giving Tenant written notice of such default and after failure by Tenant within thirty (30) days of the receipt of such notice to correct or to undertake and diligently pursue correction of said default(s) in which event the thirty day period shall be extended for a reasonable time not to exceed an additional fifteen (15) days (which notice and/or opportunity to cure shall not be required in case Landlord shall determine that an emergency exists requiring prompt action), may cure such default(s) on behalf of Tenant; and -35- Tenant shall reimburse Landlord on demand for all costs incurred by Landlord in that regard plus interest thereon from the date(s) of expenditure at the Default Rate, which shall be deemed Additional Rent payable hereunder. 26. LANDLORD'S REPRESENTATIONS AND WARRANTIES. Landlord represents and warrants to Tenant that: (a) Landlord is the fee owner of the Building and the Project; and (b) Landlord has the authority to enter into this Lease. 27. SURRENDER. Tenant shall, at the expiration of the Term, promptly quit and surrender the Premises in good order and condition and in conformity with the applicable provisions of this Lease, excepting only reasonable wear and tear and damage by fire or other insured casualty. Tenant shall have no right to hold over beyond the expiration of the Term and in the event Tenant shall fail to deliver possession of the Premises as herein provided, such occupancy shall not be construed to effect or constitute other than a tenancy at sufferance. During any period of occupancy beyond the expiration of the Term the amount of rent owed to Landlord by Tenant shall automatically become two hundred percent (200%) the sum of the Rent as those sums are at that time calculated under the provisions of the Lease. If Tenant fails to surrender the space within thirty (30) days of the termination date, Landlord may elect to automatically extend the Term for an additional month or additional year, at Landlord's option, with a Rent of two hundred percent (200%) the sum of the Rent as those sums are at that time calculated under the provisions of the Lease. The acceptance of rent by Landlord or the failure or delay of Landlord in notifying or evicting Tenant following the expiration or sooner termination of the Term shall not create any tenancy rights in Tenant and any such payments by Tenant may be applied by Landlord against its costs and expenses, including attorney's fees incurred by Landlord as a result of such holdover. Landlord agrees to treat Tenant as a holdover (as opposed to a trespasser) so long as Landlord and Tenant are negotiating in good faith to extend the term of this Lease. 28. RULES AND REGULATIONS. Tenant agrees that at all times during the terms of this Lease (as same may be extended) it, its employees, agents, invitees and licenses shall comply with all rules and regulations specified on EXHIBIT "G" attached hereto and made a part hereof, together with all reasonable Rules and Regulations as Landlord may from time to time promulgate provided they do not increase the financial burdens of Tenant or unreasonably restrict Tenant's rights under this Lease or materially and adversely affect Tenant's use or occupancy of the Premises. Tenant's right to dispute the reasonableness of any changes in or additions to the Rules and Regulations shall be deemed waived unless asserted to Landlord within ten (10) business days after Landlord shall have given Tenant written notice of any such adoption or change. In case of any conflict or inconsistency between the provisions of this Lease and any Rules and Regulations, the provisions of this Lease shall control. Landlord shall have no duty or obligation to enforce any Rule and Regulation, or any term, covenant or condition of any other lease, against any other tenant, and Landlord's failure or refusal to enforce any Rule or Regulation or any term, covenant of condition of any other lease against any other tenant shall be -36- without liability of Landlord to Tenant. However, if Landlord does enforce Rules or Regulations, Landlord shall endeavor to enforce same equally in a non-discriminatory manner. 29. GOVERNMENTAL REGULATIONS. (a) Tenant shall, in the use and occupancy of the Premises and the conduct of Tenant's business or profession therein, at all times comply with all applicable laws, ordinances, orders, notices, rules and regulations of the federal, state and municipal governments, or any of their departments and the regulations of the insurers of the Premises, Building and/or Project. (b) Without limiting the generality of the foregoing, Tenant shall (i) obtain, at Tenant's expense, before engaging in Tenant's business or profession within the Premises, all necessary licenses and permits including (but not limited to) state and local business licenses or permits, and (ii) remain in compliance with and keep in full force and effect at all times all licenses, consents and permits necessary for the lawful conduct of Tenant's business or profession at the Premises. Tenant shall pay all personal property taxes, income taxes and other taxes, assessments, duties, impositions and similar charges which are or may be assessed, levied or imposed upon Tenant and which, if not paid, could be liened against the Premises or against Tenant's property therein or against Tenant's leasehold estate. (c) Landlord shall be responsible for compliance with Title III of the American with Disabilities Act of 1990, 42 U.S.C. Section 12181 ET SEQ. and its regulations, (collectively, the "ADA") (i) as to the design and construction of exterior common areas (E.G. sidewalks and parking areas) and (ii) with respect to the initial design and construction by Landlord of Landlord's Work (as defined in Article 4 hereof). Except as set forth above in the initial sentence hereto, Tenant shall be responsible for compliance with the ADA in all other respects concerning the use and occupancy of the Premises, which compliance shall include, without limitation (i) provision for full and equal enjoyment of the goods, services, facilities, privileges, advantages or accommodations of the Premises as contemplated by and to the extent required by the ADA, (ii) compliance relating to requirements under the ADA or amendments thereto arising after the date of this Lease and (iii) compliance relating to the design, layout, renovation, redecorating, refurbishment, alteration, or improvement to the Premises made or requested by Tenant at any time following completion of the Landlord's Work. (d) Tenant shall indemnify, protect, defend and save Landlord harmless with regard to any non-compliance or alleged non-compliance by Tenant with any law, order, ordinance, regulation, permit, license or other governmental matter in any way relating to the conduct of Tenant's business or profession in the Premises. If Landlord is named as defendant or a responsible party with respect to any alleged violation or non-compliance by Tenant as aforesaid, Landlord also may require, by notice to Tenant, that the matters or conduct giving rise thereto be discontinued by Tenant unless and until the alleged violation or non-compliance is resolved in Tenant's favor. -37- 30. NOTICES. Wherever in the Lease it shall be required or permitted that notice or demand be given or served by either party to this Lease to or on the other party, such notice or demand shall be deemed to have been duly given or served if in writing and either: (i) personally served; (ii) delivered by pre-paid nationally recognized overnight courier service (E.G. Federal Express) with evidence of receipt required for delivery; or (iii) forwarded by Registered or Certified mail, return receipt requested, postage pre-paid; in all such cases addressed to the parties at the addresses set forth in Article 1(1) hereof. Each such notice shall be deemed to have given to or served upon the party to which addressed on the date the same is delivered or delivery is refused. Either party hereto may change its address to which said notice shall be delivered or mailed by giving written notice of such change to the other party hereto, as herein provided. 31. BROKERS. Tenant represents and warrants to Landlord that Tenant has had no dealings, negotiations or consultations with respect to the Premises or this transaction with any broker or finder other than the Broker identified in Article 1(k); and that otherwise no broker or finder called the Premises to Tenant's attention for lease or took any part in any dealings, negotiations or consultations with respect to the Premises or this Lease. Tenant agrees to indemnify and hold Landlord harmless from and against all liability, cost and expense, including attorney's fees and court costs, arising out of any misrepresentation or breach of warranty under this Article. 32. CHANGE OF BUILDING/PROJECT NAME. Landlord reserves the right at any time and from time to time to change the name by which the Building and/or Project is designated. 33. LANDLORD'S LIABILITY. Landlord's obligations hereunder shall be binding upon Landlord only for the period of time that Landlord is in ownership of the Building; and, upon termination of that ownership, Tenant, except as to any obligations which are then due and owing, shall look solely to Landlord's successor in interest in the Building for the satisfaction of each and every obligation of Landlord hereunder. Neither Landlord nor any of its partners shall be any personal liability under any of the terms, conditions or covenants of this Lease and Tenant shall look solely to Landlord's equity interest in the Project for the satisfaction of any claim, remedy or cause of action accruing to Tenant as a result of the breach of any section of this Lease by Landlord. In addition to the foregoing, no recourse shall be had for an obligation of Landlord hereunder, or for any claim based thereon or otherwise in respect thereof, against any past, present or future trustee, member, partner, shareholder, officer, director, partner, agent or employee of Landlord, whether by virtue of any statute or rule of law, or by the enforcement of any assessment or penalty or otherwise, all such other liability being expressly waived and released by Tenant with respect to the above-named individuals and entities. 34. AUTHORITY. Tenant represents and warrants that (a) Tenant is duly organized, validly existing and legally authorized to do business in the Commonwealth of Pennsylvania, and (b) the persons executing this Lease are duly authorized to execute and deliver this Lease on behalf of Tenant. -38- 35. NO OFFER. The submission of the Lease by Landlord to Tenant for examination does not constitute a reservation of or option for the Premises or of any other space within the Building or in other buildings owned or managed by Landlord or its affiliates. This Lease shall become effective as a Lease only upon the execution and legal deliverly thereof by both parties hereto. 36. RENEWAL. Provided Tenant is not in default of any obligations under this Lease, either at the time of exercise of this option, or at the commencement of the Renewal Term and Tenant is fully occupying the Premises and the Lease is in full force and effect, Tenant shall have the right to renew this Lease for two (2) terms of five (5) years each beyond the end of the initial Term (each, a "Renewal Term"). Tenant shall furnish written notice of its intent to renew at lease twelve (12) months prior to the expiration of the application Term, failing which, such renewal right shall be deemed waived; time being of the essence. The terms and conditions of this Lease during each Renewal Term shall remain unchanged, except that Tenant shall NOT be entitled to any additional construction allowance under Article 4 or otherwise and except the Fixed Rent to be paid by Tenant to Landlord for each year of each Renewal Term, as set forth in Exhibit B attached hereto and made a part hereof, will be the Fixed Rent for the prior year, increase by three percent (3%). Tenant hereby acknowledges that in the event that Landlord's costs in connection with those items that comprise the Operating Expenses, excluding the items listed in Section 6(a)(3) hereof, increase from time to time during the Term and any Renewal Term of this Lease, then the Operating Expenses to be charged to Tenant shall increase accordingly. As used in this Lease, the word "Term" shall include any validly exercised Renewal Term. 37. ROOF RIGHTS. (a) Tenant shall have the obligation to replace the exiting roof of the Premises, in which event the Landlord shall contribute the sume of One Hundred Fifty Thousand Dollars ($150,000.00) to Tenant upon the completion of the roof and Landlord's verification thereof. All of Tenant's work in connection with said roof shall be done in compliance with all appropriate zoning and building code statutes, laws, rules, regulations and ordinances and Tenant shall be responsible, at its own cost and expense, for the procurement of any and all permits and certificates of occupancy in connection therewith. Landlord shall have the right to approve the Tenant's choice of the roofing contractor selected by Tenant, which approval shall not be unreasonably withheld or delayed by Landlord. The roof replacement shall be effected by Tenant within the five (5) year period commencing on the Commencement Date of this Lease. Tenant shall be responsible for all maintenance, repairs and replacement of the roof during the Term and any renewal term of this Lease and, to the extent an assignment is permitted, shall be assigned all warranties and guarantees, if any, held by Landlord with respect thereto for enforcement thereof by Tenant. In the event that said warranties or guaranties cannot be assigned, Landlord, upon Tenant's request, shall take reasonable steps to enforce said warranties or guaranties. (b) So long as it (i) does not impact Landlord's roof warranty and (ii) complies with all applicable laws, rules and regulations, Tenant, at its sole cost and expense but -39- without additional charge hereunder other than utility fees which may be imposed for actual usage, shall have access to the roof of the Building in designated areas mutually agreed upon for the purpose of installation of microwave satellite, antenna and other communications devices or supplemental HVAC units and venting units (collectively, the "Roof Equipment") and with respect to telecommunications installations, Tenant shall use its best efforts to utilize US Realtel to provide such services, or such other contractor as may be acceptable to Landlord, upon its prior written consent and approval, which consent shall not be reasonably withheld or delayed. Notwithstanding the foregoing, all such Roof Equipment shall be for the sole benefit of Tenant and Landlord, shall relate specifically to Tenant's use of the Premises, and shall not be used as a switching station, amplification station or by other tenants or third parties. Tenant shall make a request for approval of the Roof Equipment hereunder by submission of specific plans and specifications for the work to be performed by Tenant. Landlord shall respond in writing within fifteen (15) business days from receipt of the same, advising Tenant of approved contractors and those portions of the work that are acceptable and disapproving those portions of the work that are, in Landlord's judgment, reasonably exercised, unacceptable and with respect to the plans, specifying in detail the nature of Landlord's objection. Tenant shall be solely responsible for the removal of all Roof Equipment and the restoration of the roof upon the expiration or early termination of this Lease unless directed in writing by Landlord otherwise. All installation, repair, replacement and modification of the Roof Equipment shall be coordinated with Landlord, shall only use those contractors approved by Landlord, which approval shall not be unreasonably withheld or delayed by Landlord, and shall be in accordance with the Rules and Regulations set forth herein. 38. MISCELLANEOUS PROVISIONS. A. SUCCESSORS. The respective rights and obligations provided in this Lease shall bind and inure to the benefit of the parties hereto, their successors and assigns; provided, however, that no rights shall inure to the benefit of any successors of Tenant unless Landlord's written consent for the transfer to such successor and/or assignee has first been obtained as provided in Article 12 hereof. B. GOVERNING LAW. This Lease shall be construed, governed and enforced in accordance with the laws of the Commonwealth of Pennsylvania, without regard to principles relating to conflicts of law. C. SEVERABILITY. If any provisions of this Lease shall be held to be invalid, void or unenforceable, the remaining provisions hereof shall in no way be affected or impaired and such remaining provisions shall remain in full force and effect. D. CAPTIONS. Marginal captions, titles or exhibits and riders and the table of contents in this Lease are for convenience and reference only, and are in no way to be construed as defining, limiting or modifying the scope or intent of the various provisions of this Lease. -40- E. GENDER. As used in this Lease, the word "person" shall mean and include, where appropriate, an individual, corporation, partnership or other entity; the plural shall be substituted for the singular, and the singular for the plural, where appropriate; and the words of any gender shall mean to include any other gender. F. ENTIRE AGREEMENT. This Lease, including the Exhibits and any Riders hereto (which are hereby incorporated by this reference, except that in the event of any conflict between the printed portions of this Lease and any Exhibits or Riders, the term of such Exhibits or Riders shall control), supersedes any prior discussions, proposals, negotiations and discussions between the parties and the Lease contains all the agreements, conditions, understandings, representations and warranties made between the parties hereto with respect to the subject matter hereof, and may not be modified orally or in any manner other than by an agreement in writing signed by both parties hereto or their respective successors in interest. Without in any way limiting the generality of the foregoing, this Lease can only be extended pursuant to the terms hereof, and in Tenant's case, with the terms hereof, and in Tenant's case, with the due exercise of an option (if any) contained herein or a formal agreement signed by both Landlord and Tenant specifically extending the term. No negotiations, correspondence by Landlord or offers to extend the term shall be deemed an extension of the termination date for any period whatsoever. G. COUNTERPARTS. This Lease may be executed in any number of counterparts, each of which when taken together shall be deemed to be one and the same instrument. H. TELEFAX SIGNATURES. The parties acknowledge and agree that notwithstanding any law or presumption to the contrary a telefaxed signature of either party whether upon this Lease or any related document shall be deemed valid and binding and admissible by either party against the other as if same were an original ink signature. I. CALCULATION OF TIME. In computing any period of time prescribed or allowed by any provision of this Lease, the day of the act, event or default from which the designated period of time begins to run shall not be included. The last day of the period so computed shall be included, unless it is a Saturday, Sunday or a legal holiday, in which event the period runs until the end of the next day which is not a Saturday, Sunday, or legal holiday. Unless otherwise provided herein, all Notices and other periods expire as of 5:00 p.m. (LOCAL TIME IN NEWTOWN SQUARE, PENNSYLVANIA) on the last day of the Notice or other period. J. NO MERGER. There shall be no merger of this Lease or of the leasehold estate hereby created with the fee estate in the Premises or any part thereof by reason of the fact that the same person, firm, corporation, or other legal entity may acquire or hold, directly or indirectly, this Lease of the leasehold estate and the fee estate in the Premises or any interest in such fee estate, without the prior written consent of Landlord's mortgagee. -41- K. TIME OF THE ESSENCE. TIME IS OF THE ESSENCE IN ALL PROVISIONS OF THIS LEASE, INCLUDING ALL NOTICE PROVISIONS TO BE PERFORMED BY OR ON BEHALF OF TENANT. L. RECORDATION OF LEASE. Tenant shall not record this Lease without the written consent of Landlord. Upon Landlord's request or with Landlord's written consent, the parties agree to execute a short form of this Lease for recording purposes containing such terms as Landlord believes appropriate or desirable, the expense thereof to be borne by Tenant. If such a short form of this Lease is recorded, upon the termination of this Lease, Tenant shall execute, acknowledge, and deliver to Landlord an instrument in writing releasing and quitclaiming to Landlord all right, title and interest of Tenant in and to the Premises arising from this Lease or otherwise, all without cost or expense to Landlord. M. ACCORD AND SATISFACTION. No payment by Tenant or receipt by Landlord of a lesser amount than any payment of Fixed Rent or Additional Rent herein stipulated shall be deemed to be other than on account of the earliest stipulated Fixed Rent or Additional Rent due and payable hereunder, nor shall any endorsement or statement or any check or any letter accompanying any check or payment as Rent be deemed an accord and satisfaction. Landlord may accept such check or payment without prejudice to Landlord's right to recover the balance of such Rent or pursue any other right or remedy provided for in this Lease, at law or in equity. N. NO PARTNERSHIP. Landlord does not, in any way or for any purpose, become a partner of Tenant in the conduct of its business, or otherwise, or joint venturer or a member of a joint enterprise with Tenant. This Lease establishes a relationship solely of that of a landlord and tenant. O. NO PRESUMPTION AGAINST DRAFTER. Landlord and Tenant understand, agree, and acknowledge that: (i) this Lease has been freely negotiated by both parties; and (ii) that, in the event of any controversy, dispute, or contest over the meaning, interpretation, validity, or enforceability of this Lease, or any of its terms or conditions, there shall be no inference, presumption, or conclusion drawn whatsoever against either party by virtue of that party having drafted this Lease or any portion thereof. P. COMPLIANCE WITH LAWS. At the commencement of Tenant's initial Lease Term, and upon Landlord's delivery of the Premises to Tenant, the exterior, and all structural elements, of the Building shall be in compliance with all municipal, county, state and federal laws, codes, and requirements. Landlord and Tenant hereby acknowledge that the respective rights and obligations of Landlord and Tenant with regard to the ADA are addressed in Section 29(c) hereof. Q. CONSENT/DUTY TO ACT REASONABLY. Regardless of any reference to the words "sole" or "absolute" (except for matters which (a) are reasonably likely to have an adverse effect on the structural integrity of the Building, (b) are reasonably likely to have an adverse -42- effect on the Building's systems, or (c) are reasonably likely to have an effect on the exterior appearance of the Building, whereupon in each such case Landlord's duty is to act in good faith and in compliance with the Lease), any time the consent of Landlord or Tenant is required, such consent shall not be unreasonably withheld, conditioned or delayed. Whenever the lease grants Landlord or Tenant the right to take action, exercise discretion, established rules and regulations or make allocations or other determinations (other than decisions to exercise expansion, contractions, cancellation, termination or renewal options), Landlord and Tenant shall act reasonably and in good faith and take no action which is reasonably likely to result in the frustration of the reasonable expectations of a sophisticated tenant or landlord concerning the benefits to be enjoyed under this Lease. R. DAYS. All references to "notice" shall mean written notice given in compliance with Section 30 of this Lease. Whenever in the Lease a payment is required to be made by one party to the other, but a specific date for payment is not set forth or a specific number of days within which payment is to be made is not set forth, or the words "immediately", "promptly" and/or "on demand", or their equivalent, are used to specify when such payment is due, then such payment shall be due within five (5) days after the party which is entitled to such payment. S. ABATEMENT OF RENT WHEN TENANT IS PREVENTED FROM USING PREMISES. In the event that Tenant is prevented from using, and does not use, the Premises or any portion thereof, for three (3) consecutive business days or ten (10) business days in any twelve (12) month period (the "Eligibility Period") as a result of (a) any damage or destruction to the Premises and/or the Building, (b) any repair, maintenance or alteration performed by Landlord after the Commencement Date and required or permitted by this Lease, which substantially interferes with Tenant's use of the Premises, (c) any failure by Landlord to provide Tenant with services or access to the Premises and/or the Building, (d) any eminent domain proceeding which substantially interferes with Tenant's use of the Premises, (e) the presence of Hazardous Materials in, on or around the Premises or the Building which poses a health risk to occupants of the Premises and are not attributable to the acts of Tenant or its employees, agents representatives, licensees or invitees, or (f) construction activities of Landlord on or about the Building and/or Project, and provided that said prevention is not caused by the acts or omissions of Tenant or its employees, agents, representatives, licensees or invitees, Tenant's rent shall be abated or reduced, as the case may be, after expiration of the Eligibility Period and for such time, on a day-for-day basis, that Tenant continues to be so prevented from using, and does not use, the Premises or a portion thereof, in the proportion that the rentable area of the portion of the Premises that Tenant is prevented from using, and does not use, bears to the total rentable area of the Premises. However, in the event that Tenant is prevented from conducting, and does not conduct its business in any portion of the Premises for a period of time in excess of the Eligibility Period, and the remaining portion of the Premises is not sufficient to allow Tenant to effectively conduct its business therein, and if Tenant does not conduct its business from such remaining portion, then for such time after expiration of the Eligibility Period during which Tenant is so prevented from effectively conducting its business therein, the Rent for the entire -43- Premises shall be abated: provided however, if Tenant re-occupies and conducts its business from any portion of the Premises during such period, the rent allocable to such preoccupied portion, based on the proportion that the rentable area of such re-occupied portion of the Premises bears to the total rentable area of the Premises, shall be payable by Tenant form the date such business operations commence. If Tenant's right to abatement occurs because of an eminent domain taking and/or because of damage or destruction to the Premises, the Building, or Tenant's property, Tenant's abatement period shall continue until Tenant has been given sufficient time and sufficient access to the Premises and/or the Building, to rebuild such portion it is required to rebuild, to install its property, furniture, fixtures, and equipment to the extent the same shall have been removed and/or damaged as a result of such damage or destruction and/or eminent domain taking and to move in over one (1) weekend. It is hereby acknowledged and agreed, however, that in the event that said prevention is caused by the acts or omissions of Tenant or its employees, agents, representatives, licensees or invitees, Tenant shall have no right to any abatement or reduction of rent hereunder. T. Secured Areas. Tenant may designate certain areas of the Premises as "Secured Areas", should Tenant require such areas for the purpose of securing certain valuable property or confidential information, or for conducting research and development or product production activities on the Premises. Tenant shall provide observation windows for all the Secured Areas. All Secured Areas shall be designated on a site plan of the Premises provided to Landlord by Tenant. Landlord may not enter such Secured Areas except in the case of emergency or in the event of a Landlord inspection, in which case Landlord shall provide Tenant with ten (10) days' prior written notice of the specific date and time of such Landlord inspection. Tenant hereby acknowledges that Landlord may be required to enter the Secured Areas in order to comply with federal, state or local statutes, rules or regulations or upon court order and shall be permitted such access in such event. Tenant may require that Landlord be accompanied by an employee of Tenant on all non-emergent entries by Landlord onto the Premises and may change locks on the Premises provided Landlord is supplied with replacement keys. U. Removal of Property. Subject to Section 11 hereof, all articles of personal property and all movable business and trade fixtures, machinery and equipment, furniture and movable partitions owned by Tenant or installed by or on behalf of Tenant in the Premises shall remain the property of Tenant, and may be removed by Tenant at any time during the Term of the Lease in accordance with the Rules and Regulations for the subject Premises. Subject to the requirements set forth in Section 11 hereof all articles of personal property and all business and trade fixtures, machinery and equipment, furniture and removal partitions owned by Tenant or installed by or on behalf of Tenant in the Premises shall remain the property of Tenant, and may be removed by Tenant at any time during the Term of the Lease in accordance with the rules and regulations for the subject premises; provided, however, that the Tenant shall be required to effect all necessary repairs in connection with said removal at its sole cost and expense and shall be required, at its sole cost and expense, to return that portion of the affected Premises to its original condition. -44- V. Construction Activities. Landlord has informed Tenant that Landlord intends to construct a multi-story building and appurtenant improvements adjacent to the Building as part of the Project. Landlord shall use its reasonable efforts to minimize the impact of said construction activities on the business operations of the Tenant. The Tenant hereby acknowledges that as part of said construction activities, Landlord shall be reconfiguring the parking lot that is part of the Premises and the Project and will be performing the Landlord Work. Tenant further acknowledges that a substantial portion of said work will most likely be conducted during normal business hours and the Landlord shall grant access to the Premises to the Tenant and its employees, agents, representatives, licensees and invitees. Landlord shall conduct such construction activities to minimize, to the extent reasonably practicable, adverse impact on Tenant's use and occupancy of the Premises arising as a result of such construction activities. 39. WAIVER OF TRIAL BY JURY. LANDLORD AND TENANT WAIVE THE RIGHT TO A TRIAL BY JURY IN ANY ACTION OR PROCEEDING BASED UPON, OR RELATED TO, THE SUBJECT MATTER OF THIS LEASE. THIS WAIVER IS KNOWINGLY, INTENTIONALLY, AND VOLUNTARILY MADE BY TENANT AND TENANT ACKNOWLEDGES THAT NEITHER LANDLORD NOR ANY PERSON ACTING ON BEHALF OF LANDLORD HAS MADE ANY REPRESENTATIONS OF FACT TO INDUCE THIS WAIVER OF TRIAL BY JURY OR IN ANY WAY TO MODIFY OR NULLIFY ITS EFFECT. TENANT FURTHER ACKNOWLEDGES THAT IT HAS BEEN REPRESENTED (OR HAS HAD THE OPPORTUNITY TO BE REPRESENTED) IN THE SIGNING OF THIS LEASE AND IN THE MAKING OF THIS WAIVER BY INDEPENDENT LEGAL COUNSEL, SELECTED OF ITS OWN FREE WILL, AND THAT IT HAS HAD THE OPPORTUNITY TO DISCUSS THIS WAIVER WITH COUNSEL. TENANT FURTHER ACKNOWLEDGES THAT IT HAS READ AND UNDERSTANDS THE MEANING AND RAMIFICATIONS OF THIS WAIVER PROVISION AND AS EVIDENCE OF SAME HAS EXECUTED THIS LEASE. 40. CONSENT TO JURISDICTION. Tenant hereby consents to the exclusive jurisdiction of the state courts located in Delaware County and Philadelphia County and to the federal courts located in the Eastern District of Pennsylvania. 41. TERMINATION OF EXISTING LEASE. Landlord and Tenant hereby agree that the current Lease between Landlord and Tenant shall terminate on the Commencement Date of this Lease. IN WITNESS WHEREOF, the parties hereto have executed this Lease under seal the day and year first above written. -45- ATTEST: LANDLORD: BRANDYWINE OPERATING PARTNERSHIP, L.P. By: Brandywine Realty Trust, its general partner /s/ Anthony A. Nichols, Jr. By:/s/ Gerard H. Sweeney - --------------------------- ------------------------------------ ANTHONY A. NICHOLS, JR. Gerard H. Sweeney, Vice President-Operations President and CEO ATTEST: TENANT: THE IMMUNE RESPONSE CORPORATION /s/ Creighton W. Lawhead By:/s/ Dennis J. Carlo - --------------------------- ------------------------------------ HEAD OF INVESTOR RELATIONS Name: Title: Pres/CEO -46- EXHIBIT "A" SPACE PLAN EXHIBIT "B" RENT SCHEDULE
Months Period Rent PSF Annual Rent Monthly Rent 1-12 11/1/99-10/31/00 $ 8.75 $459,620.00 $38,301.67 13-24 11/1/00-10/31/01 $ 9.02 $473,802.56 $39,483.55 25-36 11/1/01-10/31/02 $ 9.29 $487,985.12 $40,665.43 37-48 11/1/02-10/31/03 $ 9.57 $502,692.96 $41,891.08 49-60 11/1/03-10/31/04 $ 9.86 $517,926.08 $43,160.51 61-72 11/1/04-10/31/05 $10.16 $533,684.48 $44,473.71 73-84 11/1/05-10/31/06 $10.46 $549,442.88 $45,786.91 85-96 11/1/06-10/31/07 $10.77 $565,726.56 $47,143.88 97-108 11/1/07-10/31/08 $11.10 $583,060.80 $48,588.40 109-120 11/1/08-10/31/09 $11.43 $600,395.04 $50,032.92 121-132 11/1/09-10/31/10 $11.78 $618,779.84 $51,564.99 133-144 11/1/10-10/31/11 $12.14 $637,689.92 $53,140.83
ATTEST: LANDLORD: BRANDYWINE OPERATING PARTNERSHIP, L.P. By: Brandywine Realty Trust, its general partner /s/ Anthony A. Nichols, Jr. By:/s/ Gerard H. Sweeney - --------------------------- -------------------------------[SEAL] ANTHONY A. NICHOLS, JR. Title: Vice President-Operations ATTEST: TENANT: THE IMMUNE RESPONSE CORPORATION /s/ Creighton W. Lawhead By:/s/ Dennis J. Carlo - --------------------------- ------------------------------[SEAL] HEAD OF INVESTOR RELATIONS Title: Pres/CEO FIRST RENEWAL TERM
Months Period Rent PSF Annual Rent Monthly Rent 1-12 11/1/11-10/31/12 $12.50 $656,820.60 $54,735.05 13-24 11/1/12-10/31/13 $12.88 $676,525.32 $56,377.11 25-36 11/1/13-10/31/14 $13.27 $696,821.04 $58,068.42 37-48 11/1/13-10/31/15 $13.66 $717,725.64 $59,810.47 49-60 11/1/15-10/31/16 $14.08 $739,257.36 $61,604.78
SECOND RENEWAL TERM
Months Period Rent PSF Annual Rent Monthly Rent 1-12 11/1/16-10/31/17 $14.50 $761,435.16 $63,452.93 13-24 11/1/17-10/31/18 $14.93 $784,278.12 $65,356.51 25-36 11/1/18-10/31/19 $15.38 $807,806.52 $67,317.21 37-48 11/1/19-10/31/20 $15.84 $832,040.76 $69,336.73 49-60 11/1/20-10/31/21 $16.31 $857,001.96 $71,416.83
RENTAL SCHEDULED BASED ON 52,528 SQUARE FEET ATTEST: LANDLORD: BRANDYWINE OPERATING PARTNERSHIP, L.P. By: Brandywine Realty Trust, its general partner /s/ Anthony A. Nichols, Jr. By:/s/ Gerard H. Sweeney - --------------------------- -------------------------------[SEAL] ANTHONY A. NICHOLS, JR. Title: Vice President-Operations ATTEST: TENANT: THE IMMUNE RESPONSE CORPORATION /s/ Creighton W. Lawhead By:/s/ Dennis J. Carlo - --------------------------- -------------------------------[SEAL] HEAD OF INVESTOR RELATIONS Title: Pres/CEO EXHIBIT "C" PARKING EASEMENT AREA EXHIBIT "D" CONSTRUCTION DOCUMENTS MODIFICATIONS TO THE IRC 680 MANUFACTURING FACILITY - 1998/1999 In preparation for approval of our Remune-TM- product, modifications to the layout of the facility were necessary to meet FDA guidelines. As you can see from the attached CAD drawings (used for our 1998 meeting with the FDA), the primary area for modifications was the central portion of the building. The modifications focused on several functional areas: - Reorganization of our raw materials and quarantine area was completed. This involved installation of racking and reorganization of layout for efficient receipt of raw materials and handling of quarantined and finished goods. - Installation of a central processing area for down-stream processing of our product. This included chemical inactivation and column chromatography of the product. This process now utilizes a kill tank system for treatment of waste as permitted by our local municipality. - Reorganization and improved efficiencies in our sterile finish and fill suite areas. This included the installation of conveyor belts to improve product flow. - Improvements to the air handling and boiler/chiller systems to support the upgraded facilities. This included the installation of redundant equipment to support manufacturing consistency in the event of equipment failure. After the manufacturing area upgrades were complete, but before manufacturing had begun, Immune Response upgraded the office areas. This included the installation of a new conference room and upgraded lobby entrance. Additionally, the number of offices was increased and systems furniture was installed to support an enhanced workforce. OVERALL VIEW OF I.R.C. INCORPORATED [MAP] PLANNED ENHANCEMENT PROJECT [MAP] NEW BUILDING CONFIGURATION [MAP] EXHIBIT "E" TENANT'S LIST OF MATERIAL'S TENANT'S PERMITS DESCRIPTION OF THE HAZARDOUS MATERIALS AT IRC, INC. SUMMARY: The 680 Allendale Road facility is classified as a "small quantity generator" and does not treat any hazardous chemical waste on-site. All hazardous wastes are shipped and disposed of by licensed hazardous waste disposal contractor (current contractor is Advanced Environmental Technical Services, EPA #NJD980536593). Infectious dry waste is packaged and shipped off-site for disposal by incineration also by a licensed waste contractor (BFI, EPA #PAD150177939). After chemically inactivating and filtering our product (Remune-TM-), as part of our FDA approved manufacturing process, the resultant fluid is then thermally sterilized and then discharged into the sewer. This process is permitted under our Industrial Wastewater Discharge Permit (permit #98T-0010) issued by Upper Merion Township (a copy of the current permit is attached). Additionally, we are authorized (EPA #PAD981108384) by the Pennsylvania Department of Environmental Protection for the use, storage, and disposal of hazardous materials. As can be seen in the hazardous materials inventory below, overall quantities are very small with the exception of very dilute sodium hydroxide. The company is inspected annually by both the Upper Merion Municipal Utility Authority and by the Pennsylvania Department of Environmental Protection. Every IRC, Inc. inspection has been violation free. Due to the facility's efforts in discharge compliance and pollution prevention, the Township has awarded IRC, Inc. with the Environmental Compliance Award every year since 1996 and with the Pollution Prevention Award for the last two years. Copies of our latest awards are attached. Only those materials necessary for production are kept and only in quantities required for our manufacturing process. As is evidenced by the above mentioned inspection results, all hazardous materials are stored in proper containers and under proper storage conditions. Because of the small quantities, low risk nature of our materials, and preparedness of our Emergency Response Team, the risk of any off-site release or property damage is extremely low. The following is a specific description of the types and volumes of hazardous materials used in our manufacturing process:
CHEMICAL QUANTITY - -------- -------- 50% sodium hydroxide 20 4 Liter bottles beta-propiolactone 120 0.1 Liter bottles/month acetic acid 36 4 Liter bottles
CHEMICAL (contd.) QUANTITY - -------- -------- hydrochloric acid 12 2.5 Liter bottles methanol 4 4 Liter bottles acetonitrile 9 4 Liter bottles ethyl alcohol 2 4 Liter bottles benzyl alcohol 2 4 Liter bottles propanol 2 4 Liter bottles chloroform 1 0.5 Liter bottle dimethyl sulfoxide 1 5 milliliter bottle dithiothreital >25 grams diaminobenzidine >25 grams 1 M & 0.01 M sodium hydroxide 54 55 gallon Drums
INDUSTRIAL WASTEWATER DISCHARGE PERMIT PERMIT NO. 98T-0010 -------- UPPER MERION TOWNSHIP INDUSTRIAL WASTEWATER DISCHARGE PERMIT In accordance with the provisions of Upper Merion Township (hereafter, the Township) Ordinance No. 93-614 and 40 CFR 403.8 and 403.12, IRC, INCORPORATED 680 ALLENDALE ROAD KING OF PRUSSIA, PA 19406 Is hereby authorized to discharge industrial wastewater from the above identified facility and through the outfall(s) identified herein into the Township's sewer system in accordance with the conditions set forth in this permit. Compliance with this permit does not relieve the permittee of its obligation to comply with any or all applicable pretreatment regulations, standards or requirements under Local, State, and Federal laws, including any such regulations, standards, requirements, or laws that may become effective during the term of this permit. Noncompliance with any term or condition of this permit shall constitute a violation of Township Ordinance No. 93-614. The Township reserves the right to establish by Ordinance more stringent limitations or requirements on discharges to the wastewater disposal system if deemed necessary to comply with the objectives presented in Section 1.1 of Township Ordinance No. 93-614. This permit is being issued biannually by the Township. This biannual permit is in effect as of October 1, 1998, and expiring at midnight on September 30, 2000. By: /s/ Janet L. Serfass --------------------------- Janet L. Serfass MIPP Administrator Issued this 23 day of September, 1998. EXHIBIT F NON-DISTURBANCE AND ATTORNMENT AGREEMENT This Agreement is made on _______________, between ____________________________ ________________("Superior Mortgagee"), whose address is ______________________ ________________, BRANDYWINE OPERATING PARTNERSHIP, L.P., a Delaware limited partnership ("Landlord"), whose address is 14 Campus Boulevard, Newtown Square, Pennsylvania 19073, and THE IMMUNE RESPONSE CORPORATION, a Delaware corporation ("Tenant"), whose address is 5935 Darwin Court, Carlsbad, California 92008, who agree as follows: 1. RECITALS. This Agreement is made with reference to the following facts and objectives: (a) Superior Mortgagee is, or it is anticipated that Superior Mortgagee will become, the beneficiary under a certain mortgage ("Mortgage") on improved property located at 680 Allendale Road, King of Prussia, PA ("Property"), more specifically described in Schedule "__" attached hereto and made a part hereof by this reference. Superior Mortgagee shall also be deemed to include any lender who executes this Agreement and subsequently acquires title to the building pursuant to a bankruptcy proceeding involving Landlord. (b) On or about ____________, 199_, Landlord leased to Tenant, and Tenant leased from Landlord, the Property. A copy of the lease between Landlord and Tenant ("Lease") is attached hereto as Schedule "__" and made a part hereof by this reference. (c) The parties desire, under the provisions set forth in this Agreement, to assure Tenant that in the event of the foreclosure of the Mortgage, or in the event of a sale in lieu of such foreclosure, or in the event that Superior Mortgagee directly or indirectly becomes the new landlord of the Building because of its providing financing to Landlord, the terms of the Lease shall not be terminated, disturbed, or adversely affected, provided an Event of Default has not occurred under SECTION 23 of the Lease and subject to the cure rights set forth in SECTION 23 of the Lease ("Tenant Default"). All terms with initially capitalized letters, which are not otherwise defined in this Agreement, shall have the meanings ascribed to them in the Lease unless the context indicates otherwise. 2. SUBORDINATION. Subject to all the terms and provisions of this Agreement, the Lease and the rights of Tenant thereunder are and shall continue hereafter to be subject and subordinate to the Mortgage and to all of the terms, conditions and provisions thereof, to all advances made thereunder, to the full extent of the principal sum and interest thereon from time to time secured thereby and to any renewals, modifications, consolidations, replacements, and extensions thereof including any increase in the indebtedness secured thereby or any supplements thereto; PROVIDED, HOWEVER, that Superior Mortgagee acknowledges, consents and agrees to all the terms and provisions of the Lease and Tenant's use and occupancy of the Property thereunder. 3. ATTORNMENT. If Landlord is in default under the Mortgage after expiration of the applicable period that Landlord has in which to cure its default, and if a foreclosure sale takes place due to such default, or if Superior Mortgagee shall notify Tenant of such transfer of title to the Property or if Superior Mortgagee becomes the new Landlord of the Building, after receipt of such notice, upon the effective date of such transfer of title, and after Tenant has received written notice of such transfer of title, Tenant shall attorn to Superior Mortgagee as Tenant's landlord under the Lease, and Tenant agrees to execute any instruments reasonably requested to evidence such attornment. Upon attornment, the Lease shall continue in full force and effect, so long as a Tenant Default has not occurred, and Tenant shall perform all Tenant's obligations under the Lease directly to Superior Mortgagee, as if Superior Mortgagee were the landlord under the Lease. Tenant agrees to make any modifications of the Lease requested by Superior Mortgagee hereunder, provided that such modifications do not adversely affect any right of Tenant under the Lease or increase any of Tenant's monetary obligation s under the Lease. 4. NON-DISTURBANCE BY SUPERIOR MORTGAGEE. If a Tenant Default is not in existence at the time of the transfer of title as provided in the above paragraph, the Lease shall continue with the same force and effect as if Superior Mortgagee and Tenant had entered into a lease with the same provisions as those contained in the lease, and the terms of the Lease and Tenant's leasehold estate in the Property shall not be terminated, disturbed, or adversely affected, except according to the terms of the Lease. 5. CONDITIONS OF SUPERIOR MORTGAGEE'S RECOGNITION. Until a Tenant Default occurs, Superior Mortgagee or such other purchaser shall recognize the leasehold estate of Tenant under all of the terms, covenants and conditions of the Lease for the remaining balance of the term and any renewals thereof with the same force and effect as if Superior Mortgagee or such other purchaser were the Landlord under the Lease, and Superior Mortgagee and Tenant shall immediately enter into a written agreement with the same provisions as those in the Lease, except for any technical changes that are necessary because of the substitution of Superior Mortgagee in place of Landlord; provided, however, that Superior Mortgagee, or such other purchaser, shall not be (i) liable for any act or omission of Landlord or any other prior lessor which occurred prior to the time the Superior Mortgagee purchased or acquired its interest under the Lease, except that Tenant shall have the right to deduct from rents next due under the Lease any (a) remaining credit of Fixed Rent or Recognized Expenses and Taxes (collectively "Operating Expenses"), (b) unpaid amounts for Tenant's work (including any allowances for expansions, renewals, initial construction, remodeling or refurbishing), or the cost incurred by Tenant in constructing or completing any Landlord's Work which were required to be constructed or completed by Landlord at Landlord's expenses, (c) unpaid arbitration or court award, (d) unpaid commission due and owing to Tenant's real estate broker all as set forth in the Lease, (ii) except as provided in (i) to the contrary, obligated to cure any defaults of Landlord or any other prior lessor under the Lease which occurred prior to the time that Superior mortgage purchased or acquired its interest under the Lease (except to the extent that the default is not monetary and remains in existence at the time the Superior Mortgagee purchased or acquired its interest under the Lease and is required to be cured to allow Tenant to use the Building and the Premises for its normal and customary business operations and if after the Superior Mortgagee acquires possession of the Building, the Superior Mortgagee commences to cure such default and diligently proceeds to cure such default, Superior Mortgagee shall not be responsible for any damages caused by the prior Landlord's default), (iii) except as provided in (i) to the contrary, subject to any offsets or defenses which Tenant may be entitled to assert against Landlord or any other prior lessor, (iv) bound by any payment of rent or additional rent by Tenant to Landlord or any other prior lessor for more than one month in advance, (v) bound by any amendment or modification of the Lease which would adversely affect any right of Landlord under the Lease and without the written consent of Superior Mortgagee or such other purchaser who has first, in writing, notified Tenant of its interest, which consent cannot be unreasonably withheld, or (vi) except as provided in (i) to the contrary, liable or responsible for or with respect to the retention, application and/or return to Tenant of any security deposit paid to Landlord or any other prior lessor, whether or not still held by Landlord, unless and until Superior Mortgagee or such other purchaser has actually received for its own account as landlord the full amount of such security deposit, or any portion thereof (such liability and responsibility being limited to the amount received, if any). 6. SUPERIOR MORTGAGEE'S RIGHT TO CURE LEASE DEFAULTS. In the event of a default by Landlord or other occurrence under the Lease that would give rise to an offset against rent payable pursuant to the Lease, or a right of Tenant to terminate the Lease, Tenant will give Superior Mortgagee notice of such default or occurrence pursuant to the terms of Section 8 of this Agreement and will give Superior Mortgagee a period of the greater of (i) thirty (30) days after written notice to Superior Mortgagee, or (ii) such time as is provided to the Landlord under the Lease to cure such default or rectify such occurrence. It is understood that the time period available to Superior Mortgagee to cure such default may run concurrently with the time period available to Landlord to cure such default. Tenant agrees that notwithstanding any provision of the Lease to the contrary, it will not be entitled to cancel the Lease, or to abate or offset against the rent, or to exercise any other right or remedy until Superior Mortgagee has been given written notice of default and an opportunity to cure the same as provided herein. 7. COVENANTS OF SUPERIOR MORTGAGEE. (a) Superior Mortgagee shall, at the request of Tenant, oppose any rejection of this Lease in the event a bankruptcy proceeding is instituted involving Landlord as the debtor. (b) Superior Mortgagee shall serve Tenant, in the same manner and at the same time, with a copy of all notices it serves on Landlord with respect to any default by Landlord on any obligation of Landlord to Superior Mortgagee. 8. MISCELLANEOUS (a) NO EFFECT ON MORTGAGE. Nothing in this Agreement shall be deemed to change in any manner the provisions of the Mortgage as between Superior Mortgagee and Landlord or to waive any right that Superior Mortgagee may now have or later acquire against Landlord by reason of the Mortgage. (b) ATTORNEYS' FEES. If any party commences an action against any of the other parties arising out of or in connection with this Agreement, the prevailing party shall be entitled to recover from the losing party reasonable attorneys' fees and costs of such action. (c) NOTICE. Any notice, demand, request, consent, approval, or communication that any party desires or is required to give to another party or any other person shall be in writing and either served personally or sent by prepaid, first-class mail. Any notice, demand, request, consent, approval, or communication that any party desires or is required to give to the other party shall be addressed to the other party at the address set forth in the introductory paragraph of this Agreement. Any party may change its address by notifying the other parties of the change of address. Notice shall be deemed communicated within two (2) business days from the time of mailing, if mailed as provided in this paragraph. (d) SUCCESSORS. This Agreement shall be binding on and inure to the benefit of the parties hereto and their successors and assigns. (e) GOVERNING LAW. This Agreement shall be governed by, and construed in accordance with, the laws of the Commonwealth of Pennsylvania. (f) NO MODIFICATIONS UNLESS IN WRITING. This Agreement contains all of the agreements and understandings between the parties hereto regarding this Agreement relating to the leasing of the Premises and the obligations of Landlord and Tenant in connection with such Lease. This Agreement supersedes any and all prior agreements and understandings between Landlord, Tenant and Superior Mortgagee and alone expresses the agreement of the parties. This Agreement shall not be amended, changed or modified in any way unless in writing executed by Landlord, Tenant and Superior Mortgagee. Landlord, Tenant and Superior Mortgagee shall not have waived or released any of their rights hereunder unless in writing and executed by Landlord, Tenant and Superior Mortgagee. IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written. LANDLORD: BRANDYWINE OPERATING PARTNERSHIP, L.P., a Delaware limited partnership By: Brandywine Realty Trust, its general partner By: --------------------------------------- Its: -------------------------------------- TENANT: THE IMMUNE RESPONSE CORPORATION, a Delaware corporation By: --------------------------------------- Its: -------------------------------------- SUPERIOR MORTGAGEE: ------------------------------------------ a ----------------------------------------- By: --------------------------------------- Its: -------------------------------------- EXHIBIT "G" BUILDING RULES AND REGULATIONS LAST REVISION: NOVEMBER 1, 1999 Landlord reserves the right to rescind any of these rules and make such other and further rules and regulations as in the judgment of Landlord shall from time to time be needed for the safety, protection, care and cleanliness of the Project, the operations thereof, the preservation of good order therein and the protection and comfort of its tenants, their agents, employees and invitees, which rules when made and notice thereof given to Tenant, shall be binding upon him in a like manner as if originally prescribed provided in no event shall such modifications materially and adversely affect Tenant's use or occupancy of the Premises under the Lease. Landlord will notify Tenant in writing thirty (30) days prior to the implementation of any materials changes to the Building Rules and Regulations. 1. Sidewalks, entrances, passages, elevators, vestibules, stairways, corridors, halls, lobby and any other part of the Building shall not be obstructed or encumbered by any Tenant or used for any purpose other than ingress or egress to and from each tenant's premises. 2. No awnings or other projections shall be attached to the outside walls of the Building without the prior written consent of Landlord. 3. No showcases or other articles shall be put in front of or affixed to any part of the exterior of the Building, or placed in hallways or vestibules until the plans for said showcases or other articles have been submitted to Landlord for its approval, which approval shall not be unreasonably withheld or delayed. 4. Rest rooms and other plumbing fixtures shall not be used for any purposes other than those for which they were constructed and no debris, rubbish, rags or other substances shall be thrown therein. Only standard toilet tissue may be flushed in commodes. All damage resulting from any misuse of these fixtures shall be the responsibility of the Tenant whose employees, agents, visitors, clients, or licensees shall have caused same. 5. Subject to Tenant's right to effect Alterations to the Building as set forth in the Lease, no tenant, without the prior written consent of Landlord, shall mark, paint, drill into, bore, cut or string wires or in any way deface any part of the Building except for the reasonable hanging of decorative or instructional materials on the walls of the Building. 6. Tenants shall not construct or maintain, use or operate in any part of the project any electrical device, wiring or other apparatus in connection with a loud speaker system or other sound/communication system which may be heard outside the Premises. Any such communication system to be installed within the Premises shall require the prior written approval of Landlord. 7. No baby carriages, vehicles (other than bicycles) or animals, birds or other pets of any kind shall be brought into or kept in or about the Building. 8. Except for orders emitted by Tenant in connection with its business operations in compliance with Applicable Environmental Law (as defined in the Lease), no tenant shall cause or permit any unusual or objectionable odors to be produced upon or permeate from its premises. 9. No space in the Building shall be used for sale at auction of merchandise, goods or property of any kind. 10. No tenant may change the use of the premises from that Permitted under the Lease without the prior written approval of Landlord. 11. No tenant, or employees of Tenant, shall disturb or interfere with the occupants of this or neighboring buildings or residences by voice, musical instrument, radio, talking machines, whistling, singing or in any way. 12. No tenant shall throw anything out of the doors, windows, or down corridors or stairs of the Building. 13. Except as specified to the contrary in the Lease, Tenant shall not place, install or operate on the Premises or in any part of the Project, any engine, stove or machinery or conduct mechanical operations or cook thereon or therein except for: coffee machine, microwave oven or vending machines, or place or use in or about the Premises or Project any explosives, gasoline, kerosene oil, acids, caustics or any other flammable, explosive, or hazardous material without prior written consent of Landlord. 14. Except for the existing exterior main entry area facing Allendale Road, no smoking is permitted in the rest rooms, hallways, elevators, stairs, lobby, exit and entrances vestibules, sidewalks or parking lot area except for those exterior areas specifically designated by the Tenant, and subject to Landlord's approval, which shall not be unreasonably withheld, as smoking areas. All cigarette ashes and butts are to be deposited in the exterior containers provided for same, and not disposed of on sidewalks, parking lot areas, or toilets within the Building rest rooms. 15. Tenant shall be permitted to install its own locks and security system through the exterior and interior of the Premises provided that the Tenant shall provide to Landlord a copy of its lock and security plan upon the termination of its tenancy. In addition, the Tenant, upon the termination of its tenancy, shall return to the Landlord all keys for the Premises, either furnished to or otherwise procured by such tenant, and all security access cards to the Building. 16. Tenant shall not use the name of the Building, Landlord or Landlord's Agent in any way in connection with his business except as the address thereof. Landlord shall also have the right to prohibit any advertising by Tenant, which, in its sole opinion, tends to impair the reputation of the Building or its desirability as a building for offices, and upon written notice from Landlord, Tenant shall refrain from or discontinue such advertising. 17. Tenant shall place into effect a security system requiring all persons entering the Premises or the Building to log in when entering the Premises or Building. 18. No space within the Building, or in the common areas such as the parking lot, may be used at any time for the purpose of lodging, sleeping, or for any immoral or illegal purposes. 19. No pictures, signage, advertising, decals, banners, etc. are permitted to be placed in or on windows in such a manner as they are visible from the exterior, without the prior written consent of Landlord. 20. Tenant shall be responsible to Landlord for any acts of vandalism performed in the Building by its employees, agents, licensees, invitees or visitors. 21. No tenant shall permit the visit to its Premises of persons in such numbers or under such conditions as to interfere with the use and enjoyment of the entrances, hallways, elevators, lobby or other public portions or facilities of the Building and exterior common areas by other tenants. 22. Any work to be performed by Landlord in connection with the Premises or the Building shall be in accordance with the provisions of the Lease. Tenant's employees shall not perform any work or do anything outside of their regular duties unless under special instructions from Landlord. Requests for such requirements must be submitted in writing to Landlord. 23. Except for Landlord's negligent or intentional acts, Landlord will not be responsible for lost or stolen personal property, equipment, money or jewelry from Tenant's area or common areas of the Project regardless of whether such loss occurs when an area is locked against entry or not. 24. Tenant and its agents, employees, licensees, visitors and invitees shall observe and comply with the driving and parking signs and markers on the Building grounds and surrounding areas. ********************* [LOGO] THE IMMUNE RESPONSE CORPORATION November 10, 1999 Melinda Monostra, RPA Property Manager Brandywine Realty Trust 14 Campus Boulevard, Suite 100 Newtown Square, PA 19073 Re: 680 Allendale Road, King of Prussia, PA Dear Melinda, In accordance with the new lease dated 11/1/99 for the above referenced facility, it is our understanding we will now be responsible for operating expenses for an estimated amount of $6,250 monthly. However, as you are aware, we have paid $14,526.18 for the quarterly installment of real estate taxes and insurance. This amount is equal to three monthly payments of $4,842.06 for October, November and December. We are deducting this amount from the monthly amount due for November of $6,250. The remaining balance due for November and December is $1,407.94 per month. Enclosed is our check in the amount of $1,407.94 for November. We will include the additional amount due for December with the monthly rent check. Please feel free to contact me directly at (760) 603-3352, should you have any questions. Sincerely, /s/ Grace Turner Grace Turner Benefits and Facilities Administrator /gt [CHECK] [CHECK] [CHECK]
EX-21.1 4 EXHIBIT 21.1 Exhibit 21.1 SUBSIDIARIES OF THE REGISTRANT I.R.C. Inc., a Delaware corporation EX-23.1 5 EXHIBIT 23.1 Exhibit 23.1 CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS As independent public accountants, we hereby consent to the incorporation of our report in this Form 10-K into The Immune Response Corporation's previously filed Registration Statements on Form S-8 pertaining to the 1989 Stock Plan, the Amended and Restated 1990 Directors' Stock Plan and the Special Nonstatutory Stock Option Agreement of The Immune Response Corporation. Arthur Andersen LLP San Diego, California March 28, 2000 EX-27 6 EXHIBIT 27
5 THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE CONSOLIDATED BALANCE SHEETS AND CONSOLIDATED STATEMENTS OF OPERATIONS FOUND ON PAGES F2 AND F3 OF THE COMPANY'S FORM 10-K FOR THE YEAR-TO-DATE, AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS. 1,000 YEAR DEC-31-1999 JAN-01-1999 DEC-31-1999 4,183 18,904 0 0 0 23,289 18,956 8,196 39,997 8,603 0 9,627 0 66 18,745 39,997 0 22,082 0 37,050 0 0 45 (14,968) 0 (14,968) 0 0 0 (14,968) (.64) (.64)
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