-----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, WzYgqxX1pzAgnq529+GXq0wgA/ME/zBa3Ly/ION8KVdlM8UE9/C8Xahf3kzmvTPW 7p5yvO6bqB4NC8dKuhQdYg== 0000950150-97-000395.txt : 19970326 0000950150-97-000395.hdr.sgml : 19970326 ACCESSION NUMBER: 0000950150-97-000395 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 19961227 FILED AS OF DATE: 19970325 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: MINIMED INC CENTRAL INDEX KEY: 0000945801 STANDARD INDUSTRIAL CLASSIFICATION: ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES [3842] IRS NUMBER: 954408171 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26268 FILM NUMBER: 97562831 BUSINESS ADDRESS: STREET 1: 12744 SAN FERNANDO RD CITY: SYLMAR STATE: CA ZIP: 91342 BUSINESS PHONE: 8183625958 MAIL ADDRESS: STREET 1: 12744 SAN FERNANDO RD CITY: SYLMAR STATE: CA ZIP: 91342 10-K 1 FORM 10-K FOR PERIOD ENDED 12/27/96 1 ================================================================================ 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 (FEE REQUIRED). FOR THE FISCAL YEAR ENDED: DECEMBER 27, 1996. OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (NO FEE REQUIRED). FOR THE TRANSITION PERIOD FROM TO . COMMISSION FILE NUMBER: 0-26268 MINIMED INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) ------------------------ DELAWARE 95-4408171 (STATE OR OTHER JURISDICTION OF (I.R.S. EMPLOYER INCORPORATION OR ORGANIZATION) IDENTIFICATION NO.) 12744 SAN FERNANDO ROAD SYLMAR, CALIFORNIA 91342 (ADDRESS OF PRINCIPAL EXECUTIVE OFFICE) (ZIP CODE)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (818) 362-5958 ------------------------ SECURITIES REGISTERED PURSUANT TO SECTION 12(B) OF THE ACT: NONE SECURITIES REGISTERED PURSUANT TO SECTION 12(G) OF THE ACT: TITLE OF EACH CLASS Common Stock, $.01 par value Preferred Stock Purchase Rights 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 referenced in Part III of this Form 10-K or any amendment to this Form 10-K. [ ] The aggregate market value of the voting stock held by non-affiliates of the registrant at March 19, 1997 was $151,207,190. The number of shares outstanding of the registrant's Common Stock as of March 19, 1997 was 11,641,236. DOCUMENTS INCORPORATED BY REFERENCE: Portions of the following document are incorporated herein by reference: Part III -- The Registrant's Proxy Statement for its 1997 Annual Meeting (the "1997 Proxy"). Exhibit Index List is located at page 47. ================================================================================ 2 MINIMED INC. ANNUAL REPORT ON FORM 10-K FOR THE FISCAL YEAR ENDED DECEMBER 27, 1996
PAGE NO. -------- PART I Item 1. Business.................................................................. 3 Item 2. Properties................................................................ 22 Item 3. Legal Proceedings......................................................... 22 Item 4. Submission of Matters to a Vote of Security Holders....................... 23 PART II Item 5. Market for Registrant's Common Equity and Related Stockholder Matters..... 25 Item 6. Selected Consolidated Financial Data...................................... 26 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations................................................ 27 Item 8. Financial Statements and Supplementary Data............................... 32 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure...................................... 47 PART III Item 10. Director and Executive Officers of the Registrant........................ 47 Item 11. Executive Compensation................................................... 47 Item 12. Security Ownership of Certain Beneficial Owners and Management........... 47 Item 13. Certain Relationships and Related Transactions........................... 47 PART IV Item 14. Exhibits, Financial Statement Schedules and Reports on Form 8-K.......... 47
2 3 PART I ITEM 1. BUSINESS INTRODUCTION MiniMed(R) Inc. ("MiniMed" or the "Company") designs, develops, manufactures and markets advanced microinfusion systems for delivery of a variety of drugs, with a primary focus on the intensive management of diabetes. Substantially all of the Company's revenues have been derived from the sale of external insulin pumps and related disposables, which are designed to deliver small quantities of insulin in a controlled, programmable profile. The Company believes that it is the leading provider of these systems in the world with a present market share in the U.S. of approximately 75% for new pump sales. The Diabetes Control and Complications Trial (the "DCCT Study"), a landmark, 10-year study conducted under the auspices of the National Institutes of Health (the "NIH"), established that close control of glucose levels can prevent or delay the onset of the long-term consequences of diabetes. Other clinical studies have demonstrated that the use of insulin pumps offers many advantages over injection therapy, such as enabling patients to achieve lower glucose variability, reducing the serious consequences of diabetes and improving patients' quality of life. The Company has also developed an implantable insulin pump and is developing continuous subcutaneous glucose monitoring systems intended to enable further improvement in glycemic control and avoidance of hypoglycemic (low glucose level) and hyperglycemic (high glucose level) events. The Company's net sales of external pumps and related disposables have grown at a compounded annual rate of 30% from $11.8 million in 1990 to $57.1 million in 1996. The Company believes its primary market is Type I (insulin-dependent, juvenile-onset) diabetes patients. The American Diabetes Association (the "ADA") has estimated that there are 800,000 Type I patients in the U.S. and the Company believes that less than 5% of such patients use insulin pumps. The Company's programmable external insulin pumps are thin and lightweight (about the size of a pager) and are designed to be worn under the patient's clothing, on a belt, in a pocket or elsewhere in order not to interfere with normal daily activities. The pumps are designed to utilize the Company's proprietary disposables, consisting of an infusion set and a medication reservoir, which provide the Company with a continuing source of revenue following pump sales. The Company's external infusion pumps deliver insulin subcutaneously in hundreds of microinfusions throughout the day, more closely simulating delivery by a normal pancreas as compared to the two to four large (bolus) doses per day with injection therapy. A prospective, cross-over study published in April 1996 in Diabetes Care has shown that intensive management of diabetes by insulin pump therapy using the Company's external pump reduces the risk of hypoglycemic events four- to six-fold as compared to intensive management of diabetes by multiple daily injections. In addition to its external pumps, the Company has developed an implantable pump which to date has been utilized only for insulin delivery. The Company's programmable implantable pump is similar in function to its external pump, but is implanted under the skin of the abdomen, releasing insulin directly into the peritoneal cavity. Peritoneal delivery even more closely simulates normal pancreatic function than subcutaneous delivery via an external pump. Two recent studies presented in France found that intensive insulin therapy with an implantable pump (a majority of which were made by the Company) has significant advantages over alternative intensive management therapies for Type I patients, including providing reduced glycemic variability and a significant reduction in hypoglycemic events. A separate study published in the Journal of the American Medical Association ("JAMA") in October 1996 found that in Type II (adult onset) patients, intensive insulin therapy utilizing the Company's implantable pump, as compared to those patients using multiple daily injections, also provided reduced glycemic variability, reduced risk of hypoglycemic events without weight gain and enhanced quality of life. The Company's implantable pump has been approved for commercial sale in the European Union (the "EU"), and the special insulin used in the implantable pump is subject to a separate regulatory approval process in the EU. The manufacturer of this insulin, Hoechst AG, a German company ("Hoechst"), has applied for such approval. In the U.S., the Company and Hoechst will file a single application to the Food and Drug Administration (the "FDA"). Such application will contain both a New Drug Approval ("NDA") element for the special insulin and a Premarket Approval ("PMA") element for the pump. The Company has completed preparation of the PMA portion of the application for the implantable pump and is working with Hoechst in the preparation of the NDA element of the application for the special insulin. 3 4 Beyond intensive management of diabetes, the Company is seeking to take advantage of its drug delivery expertise by exploring applications of its pumps with drugs other than insulin. The Company believes that its pump technology is well suited for the delivery of a number of drugs that are difficult to administer, including drugs that: (i) are made up of fragile, large molecules, (ii) cannot be ingested orally, (iii) have short half-lives in vivo, (iv) require sitespecific delivery, (v) have very narrow effective ranges of concentration, (vi) require a profiled delivery pattern or (vii) would otherwise require large amounts of drugs that are either expensive or toxic in the high doses required to achieve therapeutic value. Many genetically engineered and manufactured proteins and peptides have these characteristics. The Company is in discussions with a number of biopharmaceutical companies regarding collaboration on developing the Company's infusion systems for use with drugs other than insulin and is negotiating an agreement with respect to one new drug for the treatment of HIV infection. The Company is also developing a series of continuous glucose monitoring systems, all of which utilize a sensor that can be inserted into subcutaneous tissue for continuous monitoring of glucose levels. Each sensor is expected to last approximately 3 1/2 days, after which the patient would replace it with another sensor in a different location. The Company has conducted a series of studies of its glucose sensor, involving 48 patients, and intends to initiate a multi-center clinical trial later this year. These systems are being developed to provide minimally invasive, continuous measurements and alarms that warn the patient when glucose levels become too high or too low. The Company believes these systems would provide substantial benefits over widely used glucose meters and strips that provide only intermittent measurements and can cause considerable discomfort and inconvenience as a result of the need to prick a finger to draw blood and then use a strip and a meter to determine glucose levels. Because of the expected advantages of the Company's minimally-invasive glucose monitoring systems over glucose strips and meters, the Company believes that its systems, if successfully developed, would enable better disease management and significantly improve patient compliance. MARKET OVERVIEW The Company believes that its most significant near term growth opportunity is to expand its diabetes business and that other opportunities involving application of its technology to the delivery of other drugs will become increasingly important in the future. Diabetes. Diabetes is a chronic, life-threatening disease, for which there is no known cure. In patients with diabetes, the body does not produce or respond adequately to insulin, a hormone produced by the pancreas that is critical to the metabolism of glucose. In the normal digestive process, carbohydrates in food are broken down into glucose, which is circulated in the bloodstream to the cells of the body, where it is converted into energy. The concentration of glucose in the bloodstream must be controlled within a relatively narrow range to maintain normal health. Insulin, which is secreted by the islet cells in the pancreas, is the primary regulatory mechanism by which the body metabolizes glucose. A normal pancreas produces the correct amount of insulin required to maintain a person's glucose at proper levels. In patients with diabetes, however, insulin-producing cells are destroyed or exist in reduced numbers and/or the body's cells do not effectively metabolize glucose, thereby eliminating or reducing the body's ability to control glucose levels. Diabetes is typically classified into two primary types. Type I is the more severe form of the disease and is characterized by a complete lack of insulin secretion by the pancreas, a critical and vital mechanism for controlling glucose levels. As a result, in order to maintain body chemistry balance and sustain life, Type I patients require lifelong, daily insulin therapy. In Type II diabetes (the more prevalent form of the disease), the pancreas produces some insulin but may not produce sufficient quantities to control glucose levels and/or cell metabolism of glucose may be impaired, resulting in each case in high glucose concentrations. There is a spectrum of the severity in Type II diabetes, ranging from those patients whose disease is mild and even undiagnosed, to those who can usually manage their disease by diet and exercise, to those who use various oral medications and to the most serious segment that requires use of insulin. According to the ADA, diabetes afflicts approximately 16 million people (approximately 6% of the total population) in the U.S., 800,000 of whom are estimated by the ADA to suffer from Type I diabetes. Although 4 5 patients with Type I diabetes represent the primary market for the Company's insulin pumps, there is a small but growing use of insulin pumps for Type II diabetes. Based on industry sources, the Company estimates that there are 3,500,000 Type II patients using insulin. People with diabetes experience distress at both high and low levels of glucose ("hyperglycemia" and "hypoglycemia," respectively), with significant short- and long-term negative impacts on wellness and mortality. High glucose levels occurring acutely inhibit the immune system and result in fatigue, slow healing and lower resistance to infection and, in severe cases, can lead to coma and death. High glucose levels occurring chronically can result in major, long-term complications such as retinopathy (eye disease), nephropathy (kidney disease), neuropathy (nerve disease), male impotence and cardiovascular complications (heart and blood vessel disease) such as heart attacks and strokes. Low glucose levels can also lead to complications, including fainting, weakness and, in severe cases, unconsciousness, permanent loss of cognitive power and death. Diabetes is a leading cause of blindness in adults 25 - 74 years old (in the U.S. 12,000 - 24,000 new cases annually), renal failure (more than 13,000 cases in 1990), and amputations (approximately 54,000 cases annually), according to the ADA. Based upon data from the ADA, diabetes is the sixth leading direct cause of death by disease in the U.S., accounting for approximately 160,000 deaths in 1992, not including deaths indirectly caused by diabetes, such as diabetes-related cardiovascular disease. The costs to the health care system associated with the treatment of diabetes and its complications are significant. According to a study prepared by Lewin-VHI, Inc., a market research firm, the total health care costs in the U.S. of treating people with all types of diabetes was estimated to be more than $105 billion in 1992 ($1 out of every $7 spent on health care), almost four times the cost of treating a like number of non-diabetics. This included over $60 billion for the cost of hospitalization. Therapy for Diabetes. To avoid the acute effects of diabetes and to reduce the associated complications, patients with Type I diabetes (and many Type II patients) must use insulin daily to control glucose levels. A person's glucose level will vary depending upon food intake, insulin availability, exercise, stress and illness. Until 1993 there had been an ongoing controversy as to whether glucose control alone is sufficient and how closely it must be controlled in order to avoid the complications of the disease. The DCCT Study settled this controversy, establishing that close glucose control is essential and sufficient to avoid long-term complications. To achieve good control a patient needs a continuous infusion of insulin to provide his or her background metabolic needs, as well as periodic bolus infusions for meals. Pumps can be programmed to meet these needs because they use only fast-acting insulin delivered in hundreds of microinfusions throughout the day in a profile that provides both basal levels and also bolus infusions. Conventional insulin therapy involves one or two self-administered, daily injections of long-acting (timed-release) insulin plus diet control and exercise. Intensive injection therapy requires multiple daily injections (at least three or four per day) of mixtures of long-acting (timed-release) and fast-acting (regular) insulins, as well as diet control and exercise. Because of the limited number of injections and the uneven absorption of timed-release insulins, the Company believes that neither conventional nor multiple injection therapy controls glucose levels as well as pump therapy in many patients. The Company's products have been shown in clinical trials to provide reduced glycemic variability and significantly fewer severe hypoglycemic events. To ascertain the actual amount of insulin needed, a patient must have knowledge of his or her glucose level, which should be measured at least several times per day. Currently, this is accomplished by pricking a finger with a needle, drawing a drop of blood, placing it on a disposable strip, inserting the strip into a small meter about the size of a beeper and waiting 12 seconds to two minutes for a number to appear on the display. The patient must then assess his or her carbohydrate intake and, using the measurement of glucose concentration, determine the appropriate amount of insulin required. If necessary, the patient then administers that amount of insulin using a syringe, a pen injector or an infusion pump. The Company believes that the discomfort, complexity and time associated with this entire process discourages patient compliance. In addition, the current glucose monitoring procedure provides measurements at only a few points in time. With each such determination the patient does not know if his or her glucose level is rising, falling or remaining stable, which can lead to erroneous conclusions as to the amount of insulin needed. In spite of these limitations, the present worldwide market for these glucose meters and strips and 5 6 related disposables has been estimated to be approximately $2.5 billion. The glucose monitoring technology being developed by the Company is intended to compete with these glucose meters and strips, especially for insulin-using patients, who comprise a majority of the total worldwide glucose meter and strip market. No assurance can be given, however, that the Company's glucose monitoring systems will prove to be sufficiently accurate and efficacious, or that the Company will be able to commercially market these products. DCCT Study. In 1984, the NIH initiated the $165 million DCCT Study involving 1,441 Type I diabetics who participated over the entire term of the study, which was approximately ten years. The study protocol was designed to determine whether close control of blood glucose levels, approaching "normal" levels, could prevent the onset and the progression of certain severe, long-term complications of Type I diabetes. Individuals with diabetes with mild or no significant complications were randomly divided between the "conventionally" and "intensively" managed groups. The conventionally managed group took one or two injections daily of a variety of types of mixed insulins and were required to measure their blood glucose levels once or twice per day. The intensively-managed patients were given the choice of multiple daily injections (three or more injections per day) or use of an insulin pump, and were required to take at least four glucose measurements daily. The insulin pumps provided by the NIH were MiniMed's earlier Model 504-S, although a small number of patients who had already been using other pumps were permitted to continue using their existing pumps. Among the intensively-managed patients, external pumps were utilized in 34% of the patient-years overall, and at the end of the study 42% of the intensively-managed patients were using pumps. In September 1993, The New England Journal of Medicine published the results of this landmark study, which concluded that serious consequences of diabetes were reduced significantly for the intensively treated patient group as a whole. Progression of the three primary conditions that were evaluated, retinopathy, nephropathy and neuropathy, was reduced in the intensive group relative to the conventional group by 76%, 50% and 60%, respectively. However, in the DCCT Study, the incidence of hypoglycemic events for the composite intensively managed group was three times higher than for the conventionally managed group. In spite of that finding, the NIH concluded that Type I patients should be treated intensively because the risk of hypoglycemic events was greatly outweighed by the reduction in long-term complications. In fact, the results of the study were so compelling that the study was terminated a year earlier than planned. Recent Clinical Studies. Although the protocol for the DCCT Study was not intended to compare the benefits of pump therapy with multiple daily injections, more recent studies have focused on such a comparison and have concluded that pump therapy has significant advantages. - External pump vs. multiple daily injections. In April 1996 Diabetes Care published the results of a prospective, cross-over study by Bruce Bode, M.D., et al. involving 55 patients who managed their glucose levels intensively, using multiple daily injections for at least 12 months before switching to the Company's external pump for a minimum of 12 months. The study found that the patients achieved reduced glycemic variability and a four- to six-fold reduction in severe hypoglycemic events with the pump. Reducing the number of hypoglycemic events is critically important because such events can result in fainting, weakness and, in severe cases, unconsciousness, permanent loss of cognitive power and death. - Implantable pump vs. alternative intensive management therapy in Type I patients. The EVADIAC study group in France presented two recent studies which included a comparison of pump therapy using implantable pumps (a majority of which were manufactured by the Company) to multiple daily injections and external pumps. The studies, involving more than 240 patients, found that implantable pumps had significant advantages over alternative intensive management therapies for Type I patients and a significant reduction in severe hypoglycemic events. - Implantable pump vs. multiple daily injections in Type II patients. In October 1996 JAMA published the results of a prospective, randomized study performed for the U.S. Department of Veterans Affairs which compared pump therapy using the Company's implantable pump to multiple daily injections in a total of 105 Type II patients. The study found that Type II patients with implantable pumps achieved reduced glycemic variability and reduced risk of hypoglycemic events without weight gain, as compared to those patients using multiple daily injections, and enhanced quality of life. 6 7 THE MINIMED SOLUTION Insulin Pump Technology. The Company's products for diabetes, both those already available commercially and others under development, reduce the serious complications of diabetes by enabling patients to more easily, accurately and intensively manage their glucose levels. The Company's insulin pumps have substantial advantages over conventional or intensive injection therapy, because they: - Result in Fewer Severe Hypoglycemic Events. The recent study published in Diabetes Care showed that use of the Company's external pumps reduced severe hypoglycemic events four- to six-fold when compared to multiple daily injections. Moreover, three other studies have shown that the Company's implantable pump also significantly reduced such hypoglycemic events. - Enable Rapid Insulin Absorption and Availability. The use of fast-acting insulin allows insulin to be more quickly absorbed into the blood. Timed-release insulins take considerable time before initiating metabolism of glucose, which means that a patient using injection therapy must administer an injection well before the insulin is actually needed. Changing plans can cause problems. For example, a bolus injection (a single sizable dose) of timed-release insulin should be taken 45 minutes to an hour or more before a meal, and, if the carbohydrate intake or the timing changes, glucose control is impaired. In pump therapy, which uses only fast-acting insulin, only a few minutes of lead time are required between the infusion of a bolus and the meal. This time period is even shorter with the new faster-acting insulin analog which has recently become available. - Improve Consistency of Insulin Absorption. Fast-acting insulin delivered by a pump in tiny microinfusions also has low variability in absorption. By contrast, both conventional therapy and multiple daily injections require the use of timed-release insulins, which vary in absorption within the same patient by as much as 25% or more from one day to the next. Fast-acting insulin has substantially less variability in absorption, with variability levels as low as 3% in most patients. In addition, injection therapy requires the patient to administer multiple injections of insulin in different locations in the body which may have different absorption characteristics. Pumps, in contrast, deliver the insulin through an infusion set that is connected for two to three days to a single site (usually in a patient's abdomen) thereby providing more consistent absorption. - Provide Continuous Insulin Supply. The Company's pumps deliver a continuous infusion of insulin to provide for a patient's background metabolic needs. Injection therapy, in contrast, requires the repeated administration of boluses, which form a subcutaneous depot or collection of insulin and can result in tissue scarring at the injection site. In pump therapy, fast-acting insulin is delivered in hundreds of microinfusions throughout the day, thereby reducing the creation of such depots and further improving the predictability of insulin absorption. - Enhance Control Through Programmable Delivery. Because the Company's pumps are programmable, they enable the delivery of insulin to be more closely matched to a patient's needs as they vary throughout the day. This capability is especially advantageous during sleep. In particular, many patients have been shown to suffer from a rise in early morning glucose levels (known as the "Dawn Phenomenon"). The Company's pumps can be programmed by the patient to address this condition as well as the many other predictable fluctuations in glucose levels. - Improve Patient Quality of Life. In addition to advantages related to glucose control, the Company believes its pumps provide patients with a more flexible lifestyle, an important advantage that makes pumps a particularly attractive alternative to injection therapy. To obtain good glucose control, patients using multiple daily injections must plan their schedules in advance, particularly with respect to meals and exercise, because the timed-release character of long-acting insulin requires the prediction and timing of insulin needs. Because of the flexibility of infusion pumps to deliver both a continuous background profile of fast-acting insulin and larger episodic boluses when needed before meals, patients are not restricted to the fixed schedule of eating and exercise that is required for both conventional and intensive injection therapy. They are less likely to have glucose level fluctuations as the insulin demands 7 8 of an active life are met. In addition to these lifestyle benefits, many people using the pump report that they feel much better with pump therapy. Glucose Sensor Technology. The Company is developing a series of continuous glucose monitoring systems which utilize a small, thin, pliable sensor to be inserted into subcutaneous (under the skin) tissue, usually in the abdomen or upper arm. The sensing element produces an electrical signal proportional to glucose in the interstitial fluid (fluid in the subcutaneous tissue). The sensor is connected either by cable to a small recording/display unit for some products, or to a telemetry device which transmits the signal to a recording/display unit for other products. The Company believes that its glucose monitoring systems will, if successful, offer significant advantages over current methods of monitoring glucose levels because the Company's systems would: - Improve Ability of Patients to Normalize Glucose Levels. The Company's glucose monitoring systems have been shown in limited human trials to continuously and accurately measure glucose levels as compared to standard laboratory reference equipment. Such information not only presents quantitative measurements but will allow patients to determine whether glucose levels are rising, falling or remaining stable, which will enable the patient to better manage his or her glucose level. - Warn Against Dangerously High or Low Blood Glucose Levels. Studies indicate that patients experience wide swings of glucose levels during a 24-hour period which are not easily detected even by testing with four to six finger pricks per day. With the Company's continuous glucose monitoring systems, when a sensor measurement indicates a glucose level above or below an acceptable range, an alarm will activate, in the form of an audible signal or a vibration, as well as a flashing marker on the display, providing a glucose level warning and enabling the patient to take corrective action. The Company's sensing systems will also operate during periods of sleep and will sound an alarm to wake the patient if his or her glucose level gets too high or too low. Significant variations of glucose levels during sleep can be especially serious, particularly for children. Such extreme variations of glucose levels can lead to coma, require costly hospitalization, leave permanent damage and even result in death. - Improve Patient Compliance. The Company's subcutaneous glucose sensor is inserted through the skin every 3 1/2 days, thereby avoiding multiple daily finger pricks. Because it is small, thin and pliable, the microsensor causes little, if any, patient discomfort. By avoiding the discomfort, complexity and time associated with repeatedly pricking a finger to draw blood and waiting for a meter reading of the sample, the Company's glucose monitoring system is expected to remove many of the obstacles which are believed to deter patient compliance, particularly in the case of intensive management of diabetes. A patient using the Company's glucose monitoring system would need only two sensor insertions (and possibly two calibrations) per week as compared to at least 28 finger pricks per week for recommended monitoring with strip meters in an intensive management regimen. - Enable Health Care Professionals to Establish Improved Treatment Protocols. The challenge of establishing a suitable treatment program for patients beginning intensive management is great. In some medical practices, patients are hospitalized for several days so that frequent glucose measurements can be made to enable the generation of a suitable treatment protocol for a given patient. Even this procedure has limited efficacy because the patient's behavior in the hospital is different from his or her normal lifestyle. Continuous sensing and recording outside a hospital will permit better treatment protocols to be generated at lower cost and without the need for hospitalization or close surveillance. No assurance can be given that development of the Company's sensor products will be successful or that they will be approved for commercial distribution. OTHER MEDICAL CONDITIONS The Company has gained considerable expertise from its experience with infusion of insulin, which it believes can be applied to meet the complex delivery requirements of many other drugs. Many genetically engineered and manufactured proteins and peptides have delivery problems comparable to insulin. Delivery problems for these drugs arise because they contain fragile, large molecules, cannot be ingested orally, have 8 9 short half lives in vivo, require site specific delivery, have very narrow effective ranges of concentration, require a profiled delivery pattern or would otherwise require large amounts of drugs that are either expensive or toxic in the high doses required to achieve therapeutic value. The Company is exploring opportunities for applications of delivery systems for other drugs with several biopharmaceutical companies, including a new drug under development for the treatment of HIV infection. Many of these drugs have large potential markets. For example, approximately 1,000,000 people in the United States are infected with HIV, according to an article published in JAMA in 1996. The Company is developing a series of pumps to address these delivery requirements. While the Company believes that such new applications for its pumps represent a significant opportunity for the future, its efforts in the area are at a very preliminary stage, and no assurance can be given that the anticipated collaborative efforts with biopharmaceutical companies will occur, that the development of such new applications for the Company's pumps will be successful or that such applications will be approved by the FDA or other regulatory authorities. In addition, many of the new applications may involve new drugs which themselves must be approved by the FDA in addition to the approval required for the use of the Company's infusion systems to deliver the drugs. PRODUCTS CURRENT PRODUCTS External Insulin Pumps. The Company's external pumps are designed to provide the patient with an easy, comfortable and flexible means of insulin infusion in order to maintain glucose levels. They are generally worn by the patient attached to a belt, placed in a pocket, strapped to a leg or worn on a cord around the neck. The Company's most technically advanced external pump product, the Model 507, was introduced in June 1996 and has been well received by the market. It weighs approximately 3 1/2 ounces and is about the size of a pager. The pump can accurately deliver throughout the day a controlled, programmable profile of insulin in several hundred microinfusions of one microliter each. The insulin delivery profile can thus be adjusted to meet individual needs. The insulin is delivered from the pump through special insulin-compatible tubing either to a needle or soft cannula (a tiny tube which penetrates the skin), usually into the subcutaneous tissue of the abdomen. The Model 507 represents the fourth generation of the Company's external pumps, the first of which was introduced in 1983. The Company's pumps have many safety features, including numerous alarms (36 in the Model 507), maximum limitations on the rate and amount of basal and bolus deliveries and automatic shut-off mechanisms to prevent excessive delivery of insulin. The Model 507 is easier to use and represents an improvement over the earlier Model 506. It stores a record of the timing and size of the last 12 bolus doses administered plus daily totals for the past seven days of insulin delivery. It provides the ability to set a temporary basal rate for particular activities such as exercise, and it can be programmed to turn itself off if the user does not enter a command for a specified period of time. It offers an extended bolus delivery over time ("square wave"), which is especially useful with very fast-acting insulin analogs and is especially important for high fat content foods. The Model 507 also incorporates a backlight that makes it easier for a patient to program his or her pump in low light conditions, and an audible bolus indicator for the vision impaired. In September 1996, the Company introduced its Model 505 external insulin pump. This pump is a reduced feature version of the earlier Model 506. It has full bolus programming capability but only a single basal rate. It is intended primarily for those markets where more sophisticated technology has not yet been introduced. Insulin pumps and associated disposables are prescribed by physicians to achieve better control of glucose levels. When a pump is prescribed, a nurse typically assists in teaching the patient how to use the pump and the related skills, such as calculating the appropriate amount of insulin for boluses. A patient typically returns to the physician's office for periodic check-ups and often contacts the Company's Clinical Services Department for information. While the Company's external pumps have become increasingly easy to use, physicians do not prescribe external pumps for certain patients using intensive therapy because the pumps are a relatively sophisticated means of delivering insulin and some patients do not have the motivation and ability 9 10 to understand and correctly use them. Also some patients, particularly in their teenage and early adult years, may object to pumps because they do not like the idea of having a device attached to their bodies. Disposables. The Company's external pumps are used with disposable elements consisting of a tubing set and a special syringe-type reservoir, which stores the insulin in the pump. The most popular tube sets with soft cannulas have been marketed under the trade name Sof-set. The Company has introduced more advanced versions, called the Sof-set QR (for Quick Release) and the Polyfin QR (which are similar to the earlier Sof-set and Polyfin infusion sets), both of which incorporate a quick release connector so that patients can more conveniently and discreetly disconnect the pump for showering, bathing, swimming, exercise or intimacy. These disposables provide the Company with a continuing source of revenue from pump customers. Most of these products are labeled to be replaced every 48 - 72 hours. The Company estimates that the average increase in direct cost of using external insulin pumps (including amortizing the suggested retail price of the pump over the Company's estimate of a five-year useful life plus the cost of the related disposables) over multiple daily injection therapy is approximately $1,600 per year. The amount of any offsetting savings, either short- or long-term, has not been established, although the Company believes that the longterm savings are substantial. Implantable Insulin Pump. The Company's implantable insulin pump, the MIP 2001, is similar in function to the external insulin pump but is implanted under the skin of the abdomen in a relatively minor surgical procedure. Like the external pump, the implantable pump releases a basal flow of insulin, with larger bolus doses delivered before meals. The amount of insulin released can be programmed by the patient with a hand-held communicator to meet individual needs. The communicator uses radio waves to control the pump, similar to the way radio waves are used to control cardiac pacemakers. The pump stores approximately a three-month supply of a special insulin manufactured by Hoechst and is refilled in the doctor's office from a special syringe by inserting a needle through the skin and into the pump, which then draws the insulin into its negative pressure reservoir. The negative pressure reservoir is a significant safety feature which virtually precludes the possibility of a spill of the stored medication from a reservoir leak or during refilling. Clinical trials of the Company's MIP 2001 implantable pump began in the U.S. and France in 1990. Approximately 260 patients participated in the formal trial, and approximately 350 additional patients received implantable pumps outside of the trial. By December 1996, over 1,230 patient years had been completed under the efficacy portion of the FDA protocol, involving multiple centers in the U.S. and France. Additionally, many pumps have been implanted in Europe (mostly in France) outside of the clinical trial, bringing the total number of units implanted (including replacements) through December 31, 1996 to approximately 900. The Company continues its development efforts to improve the implantable pump and to correct certain complications which arose during the clinical trials. During the early phase of the trials there was a tendency in approximately 10 - 15% of patients for blockage or clogging of the intra-peritoneal catheter or for deposits to collect on a pump valve, resulting in a decreased rate of infusion. These problems began to escalate in late 1993, resulting in the Company's decision in June 1994 to discontinue implants in new patients except for compassionate use. The escalation of the problem was traced to changes in the insulin when the supplier transferred manufacturing from a pilot facility to a production facility. The Company was able to develop a special rinsing procedure to restore full function in most patients and a "side-port catheter" to simplify this rinsing procedure. As a result, a limited number of implants were resumed in France, pending final regulatory approval of the insulin. Regulatory approval in the U.S. and the EU has been delayed by these problems with the insulin and by the amount of time required to test both pilot and full production lots of improved insulin. The Company has verified in laboratory tests that improved formulations of the insulin supplied by the manufacturer are comparable or superior to the earlier formulations that had performed acceptably in the Company's pumps. The Company has developed a new test system and predictive algorithm that enables quantitative projection of the performance of a given insulin formulation in the implantable pump. A second test system was installed by the Company at Hoechst. These systems will be used as a quality control diagnostic tool in the testing of insulin lots. 10 11 The Company received certification under applicable International Standards Organization ("ISO") quality standards and received the CE Mark in March 1995 for the MIP 2001 implantable pump, permitting commercial sale throughout the EU. However, separate approval from the EU is required for the insulin, and Hoechst has applied for this approval. No assurance can be given that such approval will be received. Full commercial distribution of the Company's implantable pump in the EU will be limited until the special insulin required for use in the pump is approved. The Company decided not to resume new patient implants in the U.S. until FDA approval is received because of the high costs of the clinical trial monitoring. The Company is continuing to pursue approval for commercial sale of the implantable pump in the U.S. and is working with Hoechst under a procedure established by the FDA for approval of a combined application for the Company's pump and the Hoechst insulin. The Company has completed preparation of the PMA element of the application for the implantable pump and is working with Hoechst in the preparation of the NDA element of the application for the special insulin. No assurance can be given that these applications will be approved by the FDA. If approved, the labeling would limit this insulin for use only in combination with the Company's implantable pump. If Hoechst were to cease its efforts to obtain FDA approval or cease to manufacture the insulin, the Company's implantable pump program would be materially and adversely affected. PRODUCTS UNDER DEVELOPMENT The Company believes that its success in the future will depend on continuing to enhance its existing products and developing new products for the treatment of diabetes and other medical conditions. External Pumps. The Company is developing a variation of its Model 507 insulin pump, known as the Model 507C, which will have the capability of storing in its electronic memory up to three months of information tracking the insulin use of the patient. A second product being developed, the data collection system, will permit health care professionals to download to a personal computer this information from the 507 or 507C, process the information using special software and print out the results in summary or graphical form. This information will enable the professional to assess the glucose control of the patient over the three month period and, where indicated, to adjust the insulin delivery protocol for the patient. The Company has operating prototypes of these products and is in the process of testing them and enhancing their design. The Company expects to seek clearance by the FDA through the 510(k) process for both these products in the summer of 1997. The Company is developing a glucose management system in collaboration with Boehringer Mannheim for use primarily in hospitals. The system is designed to enable health care professionals to better control the glucose levels of their patients. This device is expected to be submitted for FDA approval through the 510(k) process. Disposables and Accessories. The Company has developed a number of enhancements to its Sof-set infusion set which it intends to submit to the FDA for clearance under the 510(k) process, with introduction expected later this year. These enhancements include modifications which are designed to provide greater patient comfort. To facilitate the insertion of the cannula through the skin, the Company has developed a device known as the Sof-serter, which allows the patient to automatically insert the cannula. The Company is also working on a new generation of disposables known as Sof-set II. Implantable Pumps. The Company is developing an implantable Constant Flow Pump, which is not programmable. The pump is designed to be built with a pre-set flow rate specified by the physician, and is designed to be appropriate for a number of drugs other than insulin. Approval of this pump by the FDA is expected to require a PMA, and the Company expects to begin clinical trials under an IDE in late 1997 or early 1998. Glucose Monitoring Systems. The Company is developing glucose monitoring systems which are designed to provide continuous measurement of glucose levels without the need to draw blood. Although the Company's development efforts are at an advanced stage, no assurance can be given that the development of these products will be successful or that they will be approved for commercial distribution. All of these 11 12 products will utilize a small, thin, pliable microsensor, the "subcutaneous sensor," which is to be inserted into subcutaneous tissue, generally in the abdomen or upper arm, to detect glucose levels. Each sensor is expected to last approximately 3 1/2 days, after which the patient would replace it with another sensor in a different location. A series of products using this technology is planned. The first two products involve the Company's glucose sensor connected by wire to a recording/display device and others are currently planned with telemetry, permitting wireless communication. One of the first two products will provide programmable alarms for high and low glucose levels to warn the patient when glucose levels become too high or too low. This early device will record but will not display actual glucose readings. The second product will involve the same hardware but is to be used by health care professionals to evaluate glycemic control, much like a cardiologist uses a Holter monitor to monitor cardiac electrical function. This product will record glucose levels and trends for two to three days after which the data can be downloaded by the professional into a personal computer for evaluation. In using this system the patient will be asked to use various prompts to input times of meals, amounts of carbohydrate, exercise times, and other events affecting glucose metabolism. A third product will be used by patients to continuously monitor glucose levels. The Company expects to miniaturize the display unit for this device so that it can be worn like a wristwatch or carried in a pocket. The Company's sensors have been evaluated in humans in limited trials involving 48 patients. The Company will seek approval for a formal multicenter human trial of the sensors under an Investigational Device Exemption from the FDA in order to gather clinical data to support submission to the FDA for 510(k) clearance. The trial is expected to involve four geographically dispersed medical centers and approximately 40 to 60 patients. The development and production engineering of these products and various accessories including the introducer, the transmitter and the receiver/display devices are not yet complete. If clearance from the FDA is received, the Company also plans to conduct a field trial before general release. The Company believes that there will be a substantial market for its glucose monitoring sensors even if the cost of the sensors exceeds the cost of the glucose strips that they would replace. However, to maximize penetration of the glucose meter and strip market, the Company believes that it may be necessary for the price of the Company's sensors over their useful life to be reasonably comparable to the cost of presently available strips. No assurance can be given that this objective will be achieved, particularly if glucose meter companies try to compete with the Company by drastically reducing prices. Also, because of the size of its potential market, many other companies are attempting to develop non-invasive glucose measuring systems. FUTURE PRODUCTS A long-term goal of the Company is to develop a system in which a version of its implantable pump would be coupled with a long-term glucose sensor in a "closed-loop" system in what would essentially constitute an artificial pancreas. The goal is to create a device that would automatically maintain glucose levels within a normal range via feedback from the sensor to the pump to continuously adjust the rate of insulin infusion without constant intervention and programming by the patient or physician. In order for such a system to be feasible, the Company would need to develop or acquire the technology for a long-term sensor, as well as develop appropriate technology for the sensor to control the implantable pump so that they function as a closed-loop system. To that end, the Company is considering acquiring an option, exercisable prior to the end of 1998 (which option may be extended under certain circumstances to the end of 1999), to the marketing rights to long-term sensor technology under development by Medical Research Group LLC ("MRG"), an entity in which the Company's Chairman and CEO owns a significant interest. The Company is also considering acquiring from MRG certain technology under development relating to extending the useful life of the Company's implantable pump to eight to ten years. A complete closed-loop system, as described above, would require an IDE and a PMA, the timing of which are as yet undetermined. No assurance can be given that further development of the combined system of implantable pump and long-term sensor will be successful or that it will prove to be safe and effective and be approved for commercial distribution. 12 13 RESEARCH AND DEVELOPMENT The Company's research and development activities are performed primarily by its research and development organization, which consisted of 66 persons as of February 28, 1997. The Company obtains its product ideas from its staff and Medical Advisory Board, as well as patients and health care professionals, whose opinions on products are actively solicited through surveys, field visits, medical symposia, focus groups and personal relationships. See "-- Medical Advisory Board." All research and development costs are expensed as incurred, and for 1994, 1995, and 1996, research and development expenses were $5,372,000, $7,095,000 and, $7,900,000. MARKETING AND SALES Orders for the Company's external insulin pumps in the U.S. are typically placed by the patient upon the advice and recommendation of his or her physician, who provides a prescription. The Company's primary marketing efforts are focused on endocrinologists, diabetologists and other health care professionals who treat diabetes, and on third-party payors. In 1995 more than 90% of the Company's revenues from the sale of its external pumps was reimbursed by thirdparty payors (subject to applicable deductible amounts). The Company has begun to broaden its marketing efforts to include those primary care physicians who treat relatively large numbers of diabetics in managed care organizations. The Company sponsors educational symposia in intensive diabetes management for physicians, other health care professionals and third-party payors, teaching the benefits of, and providing training in, pump therapy. The Company has trained over 5,000 health care professionals in the use of its insulin pumps for intensive management of patients and intends during 1997 to conduct 80 one-day and 12 two-day symposia in the U.S. and eight one-day symposia in Europe. Boehringer Mannheim and Eli Lilly & Co. have begun to co-sponsor and contribute to the funding of these educational programs. The Company also seeks to develop patient interest in and demand for diabetes products by providing patients with access to its existing substantial service and support network, including: (i) the services of an experienced Clinical Services Department available by telephone, toll-free, 24-hours per day, seven days per week, to answer patient questions and provide guidance, advice and trouble-shooting regarding daily pump use; (ii) free short-term, replacement pumps sent within 48 hours or less to promote continuous therapy; (iii) an insurance assistance department consisting of 20 people at February 28, 1997 to answer questions, simplify and expedite claims processing and assist patients in obtaining third-party reimbursement; (iv) participation in a patient advocacy program in collaboration with the American Association of Clinical Endocrinologists; (v) an extensive Internet web site (www.minimed.com); (vi) advertisements in targeted media; and (vii) free videotapes and other educational material. Under their co-promotion agreement, the Company and Boehringer Mannheim each send targeted advertising to patients describing the other's products, including in the case of materials sent by Boehringer Mannheim, descriptions of the Company's patient service and support network. The Company has recently expanded its insurance support activities to better address the growing managed care segment of health care payors in the U.S. The Company has arrangements with over 50 third-party payors providing for reimbursement for the Company's external pumps, including contracts with U.S. Healthcare, Inc. and various Blue Cross/Blue Shield affiliates. The Company markets its diabetes products and serves customers through a combination of a direct sales organization and distributors. In addition to senior sales and marketing management and an extensive in-house support staff, as of February 28, 1997, the direct sales organization in the U.S. consisted of four regional directors, 52 field staff personnel and four field insurance coordinators. These representatives are extensively trained and specialize in diabetes therapy and the use of the Company's products. The Company compensates its sales representatives in the U.S. with a base salary, a sales commission and an annual bonus based on meeting performance objectives. In the U.S., the Company also contracts with nurse educators (many of whom are registered nurses) who assist in educating potential patients about use of the Company's external pumps. The Company believes that its strategy of maintaining its own direct sales force dedicated to diabetes is an important factor in market development and an important competitive advantage. Nevertheless, the 13 14 Company also utilizes independent distributors in the U.S. to augment its direct sales force and increase the number of physicians served. Internationally, independent distributors are used to provide sales coverage in geographic areas not served by the Company's direct sales force. Also, some third-party payors in the U.S. require that certain classes of purchases be made through specified distributors, and certain distributors in the U.S. and internationally maintain substantial infrastructure to support physician and patient needs. In 1996 42% of revenues were attributable to sales by the Company's direct sales force. Internationally, the Company has its own sales organizations for France, Germany, the Netherlands, Belgium and Luxembourg, consisting of 19 people at February 28, 1997, including administrative staff. The Company has a distribution manager in the United Kingdom and utilizes independent distributors in other countries. The Company believes that the international market provides a significant opportunity for growth and is seeking to expand its international sales. International sales increased from 7.4% of total revenues in 1992 to 14.2% in 1996. Also, the Company expects that some of its new products and new applications will be introduced in foreign countries prior to their introduction in the U.S. because the regulatory approval process in other countries has generally been less time consuming and less expensive than in the U.S. MANUFACTURING The Company purchases from outside vendors most of the components, certain subassemblies and various services used in the manufacture of its products. The purchased items are generally produced to the Company's specifications and in many instances to the Company's designs. The Company then assembles the components into finished products. Certain disposable products have been purchased from OEM suppliers. The Company's Quality Assurance Department provides guidance to vendors and performs inspections and product tests at various steps in the manufacturing cycle to ensure compliance with the Company's stringent specifications. The manufacturing facilities are subject to periodic inspection by regulatory authorities. See "-- Government Regulation." In 1995 the Company was approved under ISO 9002 relating to quality standards, and in 1996 it was approved under ISO 9001 relating to design control standards. Such approvals enable the Company to quickly introduce certain products into the EU based on annual certification of the Company's quality system. In 1996 the Company instituted Demand Flow Technology manufacturing procedures. This version of "Just in Time" manufacturing is intended to significantly reduce total manufacturing cycle times, thereby reducing inventories. Also, the manufacturing line can then be more responsive to customers orders, quality is improved and manufacturing costs and paperwork are reduced. The Company relies on single sources for certain critical components, including hybrid circuits, integrated circuits, pumping elements, special batteries, special insulin formulations, and various disposable products and components as well as a sole source subcontract arrangement for sterilization services. Arrangements for additional or replacement suppliers for certain of these components could not be accomplished quickly. The loss of any of these vendors as a supplier could have a material adverse effect on the Company's business, financial condition and results of operations. COMPETITION At present the Company considers its primary competition in the diabetes market to be injection therapy. The Company competes against injection therapy primarily by educating doctors, nurses, patients and managed care organizations and other third-party payors about the need for intensive management of glucose levels and the advantages of pump therapy over multiple daily injections. In the sale of its external pumps, the Company competes with Disetronic Medical Systems AG, a Swiss company ("Disetronic"), which introduced a competitive external pump product in the U.S. approximately six years ago. The Company estimates that Disetronic currently has approximately 25% of the U.S. market for external pumps for new patients. Internationally, in addition to Disetronic, the Company competes in the insulin pump market against several smaller suppliers which generally offer less sophisticated products. The Company competes with other pump makers primarily on the basis of product design, quality and utility, 14 15 physician and patient education and support services and price. There can be no assurance that past, current and potential makers of competitive pumps, some of which may have substantially greater financial, technical, marketing and other resources than the Company, will not become more significant factors in the future. In the sale of its disposable products, the Company competes with Maersk Medical A/S, a Danish company ("Maersk"), which has introduced a disposable system that is compatible with the Company's pumps and is intended to compete with the Company's Sof-set QR. Other companies may be considering the manufacture and sale of disposables intended for use with the Company's pumps. If any such products are successful, they will divert sales of the Company's disposables, which could have an adverse effect on the Company business, financial condition and results of operations. A number of companies, including Strato-Infusaid, Inc. (a subsidiary of Pfizer Inc.), Medtronic, Inc., Therex Corp. (a subsidiary of Arrow International, Inc.) and Siemens-Elema (a subsidiary of Siemens AG), have, or have attempted to, develop and market implantable microinfusion pumps. Infusaid, Therex and Tricumed Medizintechnik GmbH, a small German company (whose marketing and manufacturing rights for the Anschutz Pump were recently acquired by Medtronic Inc.), manufacture non-programmable pumps, which are adequate for delivery of certain drugs other than insulin and which are less expensive than programmable insulin pumps. Siemens discontinued its efforts to develop an implantable insulin pump in 1994. More recently, Strato-Infusaid has discontinued its insulin program, leaving MiniMed as the only company known to it to be actively pursuing the application. Infusaid, Medtronic and Therex have each obtained FDA approval for use of their implantable pumps with certain drugs other than insulin. Certain of these potentially competitive companies have substantially greater financial, technical, manufacturing, marketing and other resources than the Company. Numerous companies, some of which have substantially greater financial, technical, manufacturing, marketing and other resources than the Company, are attempting to develop non-invasive glucose measurement systems. Many of these noninvasive efforts are being directed to near-infrared spectroscopic measurements through tissue, such as by analysis of light reflectance from an arm or transmission through a finger inserted into a well, through an ear lobe or through other tissue. The technical obstacles to such technologies are substantial and to date no such instrument has been approved for commercial distribution by the FDA. However, if such efforts are successful and provided universal calibration is possible (so far all reports indicate that even with extensive, individual calibration, results are not adequate), then applications that can be adequately served by intermittent measurements, such as measurements in doctors' offices, might be served with such instruments. There are also several efforts directed to reducing the discomfort associated with the finger pricks required with current glucose meter systems by reducing the depth of penetration of the needle, using a laser and/or using other methods to breach the outer derma layers so as to extract interstitial fluid rather than blood. There are also other approaches being pursued for glucose level determination. Several are attempting to draw out interstitial fluid by electrical or chemical means and then measuring the glucose. There are also at least three other efforts being directed toward subcutaneous measurement with electrochemical sensors. It is possible that some patients might prefer such systems to the Company's continuous glucose monitors for routine monitoring. The successful development and acceptance of non-invasive or minimally invasive glucose measurement systems or systems without pain could therefore have a material adverse effect on the Company's glucose sensor program. A number of companies and medical researchers are pursuing new delivery devices, delivery technologies, procedures, drugs and bioengineered therapeutics for the treatment and prevention of diabetes, such as, for example, pancreas transplantation and insulin-producing islet and beta cell preparations and devices. If successful, these technologies and/or medical procedures could have a material adverse effect on the Company's business, financial condition and results of operations and could possibly render the Company's products obsolete. PATENTS, PROPRIETARY RIGHTS AND TRADEMARKS The Company files patent applications to protect technology, inventions and improvements that it considers important to the development of its business. The Company currently holds numerous issued U.S. 15 16 patents and foreign patents and has pending many U.S. and foreign patent applications that cover various aspects of its technology. In addition, the Company holds fully paid, non-exclusive, worldwide licenses to several patents relating to infusion pumps and a license to numerous other patents relating to implantable pumps. Litigation may be necessary to enforce patents issued to the Company, to protect trade secrets or know-how owned by the Company or to determine the enforceability, scope and validity of the proprietary rights of others. Although the Company knows of no infringement of patents held by others, it is always possible that a third-party may assert infringement. The Company believes that it owns or has the right to use all technology incorporated into its products, but an adverse determination in any litigation or interference proceeding to which the Company may become a party could subject the Company to significant liabilities to third parties or require the Company to seek licenses from third parties. Although patent and intellectual property disputes in the medical device area have often been settled through licensing or similar arrangements, associated costs may be substantial and could include ongoing royalties. Furthermore, there can be no assurance that necessary licenses would be available to the Company on satisfactory terms or at all. Accordingly, an adverse determination in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent the Company from manufacturing and selling certain of its products or its planned products, which would have a material adverse effect on the Company's business, diversification opportunities, financial condition and results of operations. The Company owns the trademarks MiniMed, Sof-set, QR, Sof-set QR, Polyfin, and certain other trademarks. The Company also relies on certain trade secrets and proprietary know-how that it seeks to protect, in part, through confidentiality agreements with its employees and consultants. There can be no assurances that any unprotected information will not also be developed by others. GOVERNMENT REGULATION Clinical testing, manufacture and sale of the Company's products are subject to regulation by numerous governmental authorities, principally the FDA and corresponding state and foreign agencies. In the U.S., the Company is required to register as a medical device manufacturer with the FDA and state agencies such as the Food and Drug Branch of the California Department of Health Services ("DHS"). The Company is subject to inspection on a routine basis by both the FDA and the DHS for compliance with the FDA's GMP regulations. These regulations impose certain procedural and documentation requirements upon the Company with respect to manufacturing and quality assurance activities. Hoechst, the manufacturer of the special insulin to be used in the Company's implantable pump, is also subject to regulation and inspection by the FDA, as well as European regulatory agencies. Under the Federal Food, Drug and Cosmetic Act (the "Act"), as amended, medical devices are classified into one of three classes (i.e., Class I, II, or III) on the basis of the controls necessary to reasonably ensure their safety and effectiveness. Safety and effectiveness can reasonably be assured for Class I devices through general controls (e.g., labeling, premarket notification and adherence to GMPs) and for Class II devices through the use of general and special controls (e.g., performance standards, postmarket surveillance, patient registries, and FDA guidelines). Generally, Class III devices are those which must receive PMA by the FDA to ensure their safety and effectiveness (e.g., life-sustaining, life-supporting and implantable devices, or new devices which have been found not to be substantially equivalent to legally marketed Class I or Class II devices). Before a new device can be introduced to the market, the manufacturer generally must obtain FDA clearance through either a 510(k) premarket notification or a PMA. A 510(k) clearance will be granted if the submitted data establishes that the proposed device is "substantially equivalent" to a legally marketed Class I or Class II medical device, or to a pre-amendment Class III medical device for which the FDA has not called for PMAs. Generally an application for 510(k) clearance only requires submission of a file, including design, manufacturing, test and marketing information, including labeling. However, in some cases the FDA requires clinical trials under an IDE (as defined below), even for products to be cleared under the 510(k) process, although in such instances these trials are generally relatively small and of short duration. It generally takes 16 17 from four to 12 months from submission to obtain 510(k) premarket clearance, but may take longer, and there can be no assurance that the Company will obtain 510(k) premarket clearance within this time frame, if at all, for any of the devices for which it may file a 510(k) notice. The FDA may determine that the proposed device is not substantially equivalent, or that additional data are needed before a substantial equivalence determination can be made. A "not substantially equivalent" determination, or a request for additional data, could delay the market introduction of new products that fall into this category and could have a material adverse effect on the Company's business, financial condition and results of operations. A PMA must be filed if the proposed device is not substantially equivalent to a legally marketed device or if it is a pre-amendment Class III device for which the FDA has called for PMAs. In addition, a "new drug" may not be marketed without an approved NDA establishing the safety and effectiveness of the drug for its intended uses. The NDA process is typically costly, lengthy and uncertain. In order to obtain a PMA, a device that poses a significant risk to patients must undergo clinical evaluation under an Investigational Device Exemption ("IDE") that is granted by the FDA to permit testing of the device in a limited number of humans in clinical trials conducted at a restricted group of clinical sites. Similarly, a new drug, such as the insulin used for the implantable pump, must be evaluated in an Investigational New Drug ("IND") trial. In addition to obtaining from the FDA an IDE approval or IND authorization to conduct a clinical trial, the sponsor of the investigational research must also obtain approval for the clinical research from an institutional review board or committee established for this purpose by each medical center where the trials will be conducted. Clinical trials leading to a PMA or an NDA are intensive and costly activities that usually extend over two or more years. As the clinical trial progresses under an IDE or IND, the FDA may at certain milestones allow expansion of the scope of the trial to allow additional patients or additional clinical sites or both. In late 1991, the FDA adopted new procedures for the review of products that involve both devices and drugs, which permit clinical investigation and approval to be coordinated by a lead center of the FDA. The Company's implantable pump and the associated insulin comprise a combined device/drug system that will be regulated under these procedures. Following the adoption of these procedures, the Company, which had already submitted a PMA application for the Company's MIP 2001 implantable insulin pump, withdrew its initial application for a PMA and the Company and Hoechst intend to submit a single application to obtain FDA approval of the combination product. This is the first time that Hoechst has sought FDA approval to market insulin in the U.S. Although the Company and Hoechst will file a single application, it will contain both an NDA element for the insulin and a PMA element for the pump. The FDA's Center for Drug Evaluation and Research will be the lead center and will review the NDA portion of the application, while the Center for Devices and Radiological Health will be responsible for reviewing the PMA portion. The Company anticipates that, if the FDA grants approval, such approval would include issuance of an approved NDA for the insulin and an approved PMA for the pump. There can be no assurance, however, that the application will ever be approved. Under the Act, even after approval, each batch of insulin produced by Hoechst for the combination product would require FDA's certification that the batch meets requisite strength, quality and purity standards. Clinical trial results are presented to the FDA in a PMA or NDA application. In addition to the results of clinical investigations, the applicant must submit other information relevant to the safety and efficacy of the device and/or the drug, including the results of non-clinical tests, a full description of the device and/or drug and their components, a full description of the methods, facilities and controls used for manufacturing, and proposed labeling. Such submissions are extremely detailed and complex, often involving tens of thousands of pages. The FDA staff then reviews the submitted application and determines whether or not to accept the application for filing. There is no assurance that either the safety or efficacy data in these submissions will be deemed sufficiently complete and adequate by the FDA, and if they are not, a final determination by the FDA could be delayed while additional trials are performed or the project could be abandoned. Such trials would add significant new costs to such a program, which would have a material adverse effect on the Company's business, financial condition and results of operations. 17 18 If accepted for filing, the applications are further reviewed first by the FDA staff and, if appropriate, subsequently by an FDA scientific advisory panel comprised of physicians and others with expertise in the relevant field. A public meeting is held before the advisory panel in which the PMA or NDA application is reviewed and discussed. The scientific advisory panel then issues a recommendation of approval or denial to the FDA or recommends approval with conditions. Although the FDA is not bound by the opinion of the advisory panel, the FDA tends to give considerable weight to panel recommendations. If the FDA's evaluations of the application are favorable, the FDA will subsequently publish an order approving the PMA application or NDA application. Interested parties can file comments on the order and seek further FDA review. Although by statute the FDA is granted 180 days in which to review a PMA or NDA and either approve or disapprove it, in practice the FDA has often taken much longer. Generally, during the review, the FDA will request additional data and the applicant will agree to extend the review time. The FDA will make an initial assessment as to whether the PMA or NDA is sufficiently complete for review and may require the development and submission of additional data or analysis. The PMA and NDA processing in the past has typically lasted more than a year from the time of filing, and in some cases several years, but the FDA is being pressured to meet its statutory timelines. Many such reviews are now being completed within six months, but others are not, and there is no assurance when or if an application will be approved. New PMA applications or PMA supplements are required for certain modifications to a device that is approved through the PMA process. Supplements to a PMA application often require submission of the same type of information as for a PMA application except that the supplement is limited to information needed to support any changes from the product covered by the original PMA application and may not require the submission of clinical data or the convening of an advisory committee and corresponding review. In addition, certain changes, including changes to the labeling, manufacturing, dosage, or route of administration of an approved new drug require the approval of a supplement to the NDA application prior to initiating such changes. Submission of significant NDA supplements often require data similar to that submitted with the original NDA application. Likewise, with respect to the implantable pump and insulin combination product, certain changes to the product (e.g., design, labeling, manufacturing, dosage, route of administration) would require FDA's approval of a supplement to the original application. At the present time, FDA has indicated that there will be only one holder of the approved application for the pump and insulin combination product. The holder will be the entity entitled to file such supplements. The Company is seeking an arrangement with the FDA and Hoechst whereby the Company would be the approved application holder, but there can be no assurance that such an arrangement will be achieved. If the Company does not hold the approved application, then its ability to obtain FDA approval of modifications to the device would require appropriate contractual arrangements with Hoechst, or possibly would require obtaining a new PMA, which could have a material adverse effect on the Company. The PMA and NDA processes can each be expensive, uncertain and lengthy, and a number of devices and drugs for which PMA or NDA approval has been sought have never been approved for marketing. There can be no assurance that the Company will be able to obtain necessary regulatory approvals or clearances on a timely basis or at all for any of its products under development, and delays in receipt of or failure to receive such approvals, the loss of previously received approvals, or failure to comply with existing or future regulatory requirements would have a material adverse effect on the Company's business, financial condition and results of operations. Approvals restrict devices and drugs to specifically labeled uses, and the combination pump/insulin product would be similarly restricted. The FDA actively enforces regulations prohibiting marketing of products for unapproved uses. The FDA also conducts inspections to determine whether the Company conforms with GMP, and subsequent GMP inspections will continue after the FDA approval. A GMP inspection was last completed in February 1995, with only one minor citation, which has been corrected. A further such inspection may be conducted relative to any PMA application submitted by the Company for other products or pursuant to the FDA's practice of performing periodic inspections. 18 19 Failure to comply with applicable regulatory requirements can result in, among other things, fines, injunctions, civil penalties, failure of the government to grant premarket clearance or premarket approval of devices or drugs, delays or suspensions or withdrawals of approvals, seizures or recalls of products, operating restrictions and criminal prosecutions. Changes in existing requirements or adoption of new requirements could have a material adverse effect on the Company's business, financial condition and results of operations. The FDA can withdraw an NDA or PMA approval if new evidence or new information shows the drug or device is no longer safe or effective, or if the FDA discovers that the NDA or PMA contains any untrue statement of material fact. Other reasons justifying withdrawal of an NDA or PMA by the FDA include, but are not limited to, failure to maintain required records or to file records and reports, new questions regarding manufacturing, and whether labeling is false or misleading. Exports of products subject to 510(k) notification requirements, but not yet cleared to market, are permitted without FDA export approval, provided that certain requirements are met. Unapproved products subject to PMA requirements must receive prior FDA export approval unless they are approved for use by any member country of the EU and certain other countries, including Australia, Canada, Israel, Japan, New Zealand, Switzerland and South Africa, in which case they can be exported to any country without prior FDA approval. International sales are subject to foreign government regulation, the requirements of which vary substantially from country to country. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA approval, and the requirements may differ. Within the next several years, a company must obtain the CE Mark prior to sale within the EU of certain medical devices, including implantable products. During this process, the sponsor must demonstrate compliance with ISO manufacturing and quality requirements. The Company received approval for use of its implantable insulin pump in France in June 1993. In March 1995, the Company obtained the CE Mark to market its implantable pump throughout the EU, but full commercial distribution of the Company's implantable pump in the EU will be limited until the special insulin required for use in the pump is approved and made available. See "-- Products -- Current Products -- Implantable Insulin Pump." In March 1995, the Company received certification under applicable ISO 9002 quality standards and in July, 1996 received certification under ISO 9001 design control standards. As is the case with GMP inspections in the U.S., inspections by foreign bodies will continue in the EU on a periodic basis after receipt of the CE Mark. The Company also is subject to numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control and disposal of hazardous or potentially hazardous substances. Additionally, the Company must comply with various FDA, and in some cases Federal Trade Commission, requirements for design, safety, advertising, labeling, record keeping and reporting of adverse experiences with the use of a product. There can be no assurance that the Company will not be required to incur significant costs to comply with such laws and regulations in the future or that such laws or regulations will not have a material adverse effect upon the Company's ability to do business. External pumps have generally qualified for clearance under Section 510(k), although certain features of advanced pumps may require clinical validation. The Company's Models 507 and 506 external pumps have all been cleared by the FDA pursuant to the Section 510(k) premarket notification process and a 510(k) notification has been submitted with respect to Model 505. Modifications or enhancements to the Company's products that are cleared through the 510(k) process that could significantly affect safety or effectiveness will require new submissions. The Company has made certain changes to its cleared devices which the Company believes do not require the submission of new 510(k) notifications. However, there can be no assurance that the FDA will agree with the Company's determinations and not require the Company to submit new 510(k) notifications for any of these modifications. The Company believes short term subcutaneous glucose monitor may be cleared through the 510(k) process after a limited clinical trial, but there is no assurance that the FDA will not later require the more stringent PMA application process for such devices. There can be no assurance that the necessary approvals for the use of new generations of the Company's external pumps and disposables, the Company's implantable insulin pump or its glucose monitoring systems will be granted by the FDA or other authorities on a timely basis or at all, and delays in receipt of or failure to 19 20 receive such approvals, or the loss of previously received approvals, could result in significant delays, substantial costs or even the cessation of operations relating to a product or group of products, and any of these could have a material adverse effect on the business, financial condition and results of operations of the Company. THIRD-PARTY REIMBURSEMENT In the U.S., the Company's products are generally purchased directly by patients, physician groups, hospitals, and/or dealers. In many cases the Company, on behalf of the patients, bills third-party payors, including private insurance companies, health maintenance organizations, preferred provider organizations, other managed care providers, and, to a limited extent, Medicaid. Under the Medicaid program, states generally reimburse for approved procedures on a reasonable cost or fee schedule basis. Currently, certain states reimburse for the Company's products under the Medicaid program. Although the Company does not currently derive revenues from the Medicare program for any of its products, it is in the process of seeking coverage for its external pump. The Company believes that the primary value of Medicare coverage for diabetes today is that it facilitates reimbursement by many other third party payors because they follow Medicare guidelines. Although, the Clinton Administration's plan to address the crisis in the Medicare Trust Fund recently announced is directed toward reducing costs further, it also contains provisions directed specifically towards expanded coverage for certain chronic diseases, including diabetes. There is no certainty that these proposals expanding coverage for diabetes will be enacted or, if so, whether the Company's products would benefit. The Company maintains an insurance assistance department consisting of 20 people at February 28, 1997 to simplify and expedite claims processing and to assist patients in obtaining third-party reimbursement. Based upon sales made by the Company's direct sales force (which represent 42% of the total revenues), in 1995 the Company believes that more than 90% of the revenues from Company's external pump sales represented reimbursement by third-party payors (subject to applicable deductible amounts). Third-party payors may also decline to reimburse for procedures, supplies or services determined to be not "medically necessary" or "reasonable." Certain payors have initially indicated that they would decline to reimburse for certain of the Company's products on that basis. The Company attempts to deter and reverse such practices through education and has expanded its insurance assistance efforts toward this end. These efforts are usually successful, but such reimbursement may become less likely in the future as pressure continues to mount for lower health care costs. Medicare and many other third-party payors also do not reimburse for procedures deemed "experimental" or "investigational." There is usually no precise date when a procedure ceases to be experimental or investigational, but devices in clinical investigation under an IDE are usually deemed to be experimental or investigational. The failure to cover early use of a procedure deters usage, delaying acceptance even longer. Use of implantable pumps is still considered to be an investigational procedure by many third-party payors in the U.S. and reimbursement for the small number of pumps sold in the U.S. has therefore been limited to date. There is widespread concern that health care market initiatives in the U.S. may lead third-party payors to decline or further limit reimbursement. The extent to which third-party payors may determine that use of the Company's products will save costs or will at least be cost effective is highly uncertain, and it is possible, especially for diabetes, that they will merely focus on the lower initial costs associated with injection therapy or will otherwise limit reimbursement for insulin pumps or other products developed by the Company. Because of uncertainties regarding the possible health care reform measures that could be proposed in the future and initiatives to reduce costs by private payors, the Company cannot predict whether reimbursement for the Company's products will be affected or, if affected, the extent of any effect. The unavailability of third-party coverage or the inadequacy of reimbursement for the Company's products would materially and adversely affect the Company's business, financial condition and results of operations. 20 21 PRODUCT LIABILITY AND WARRANTIES The Company's products are generally warranted for various periods ranging from two to four years. The special motors contained in the Company's external pumps are warranted for life. The Company sets aside a reserve based on monthly return rates to pay for customer service and repair of products. Additional reserves are set aside during early stages of product introduction. The Company believes such reserves to be adequate, but in the event of a major product problem or recall, the reserves may be inadequate to cover all costs, and such event could have a material adverse effect on the Company's business, financial condition and results of operations. The Company's business involves the inherent risk of product liability claims. The Company maintains product liability insurance with coverage limits of $15 million per occurrence and an annual aggregate maximum of $15 million, with a deductible of $25,000 per occurrence. There can be no assurance that this insurance coverage will continue to be available on terms acceptable to the Company or that such coverage will be adequate for liabilities actually incurred. EMPLOYEES As of February 28, 1997, the Company employed 373 full-time persons, plus 34 temporary employees, including 66 in research and development, 145 in manufacturing, production engineering and quality assurance, 74 in administration and 122 in sales and marketing. The Company believes that the success of its business depends, in part, on its ability to attract and retain qualified personnel, particularly qualified scientific, technical and key management personnel. The Company believes its relationships with its employees are good. MEDICAL ADVISORY BOARD A Medical Advisory Board, consisting of five individuals with recognized expertise in fields relating to diabetes care and treatment, has been organized to advise the Company concerning long-term product planning, research, development and marketing of its diabetes treatment products. Members of the Medical Advisory Board consult and meet formally and informally with the Company. Certain members of the Medical Advisory Board are employed by academic institutions and may have commitments to or consulting or advisory agreements with other entities that may limit their availability to the Company. Members of the Medical Advisory Board may also serve as consultants to other medical product companies. The members of the Medical Advisory Board have agreed, however, to maintain the confidentiality of all proprietary information disclosed to them by the Company. In addition, any ideas, inventions, developments, improvements and works of authorship developed by the members of the Medical Advisory Board relating to insulin pumps or glucose sensors are the property of the Company. Currently, the following persons comprise the Company's Medical Advisory Board: Jay S. Skyler, M.D. (Chairman), is a Professor of Medicine, Pediatrics and Psychology at the University of Miami in Miami, Florida, past President of the American Diabetes Association, and current Vice-President of the International Diabetes Federation. Dr. Skyler is the Chairman for the NIH-sponsored Multi-center Diabetes Prevention Trial. Dr. Skyler is the author of numerous research and review articles, many of which focus on the complications of diabetes and the risk reduction of such with intensive diabetes management. Irl B. Hirsch, M.D., is Associate Professor of Medicine at the University of Washington School of Medicine in Seattle, Washington and the Medical Director of the Diabetes Care Center at the University of Washington in Seattle, Washington. Dr. Hirsch has been an Associate Editor for Clinical Diabetes (a medical journal specializing in diabetes) since 1992 and is a reviewer for several scientific and medical journals. From 1993, he has been a consultant to the Diabetes Control Project in the state of Washington. He is the author of numerous articles covering topics such as use of insulin pump therapy to treat hypoglycemia, insulin treatment during surgery and an update on insulin therapy for family practitioners. Dr. Hirsch recently published a book with the ADA for individuals with diabetes entitled, How To Get Great Diabetes Care: What You and Your Doctor Can Do to Improve Your Medical Care--And Your Life. Dr. Hirsch has diabetes and uses the Company's Model 507 insulin pump. 21 22 Francine Ratner Kaufman, M.D. is an Associate Professor of Pediatrics at the University of Southern California School of Medicine. Dr. Kaufman was past President of the Board of Directors of the Los Angeles Chapter of the ADA (1988-1990, 1993-1994) and is President of the Board of Directors of the California affiliate of the ADA. She is a member of the national ADA Board of Directors, where she is on the Professional Practice Committee and a member of the Clinical Initiatives Committee of the Endocrine Society. For the past five years, she has been an associate editor for Clinical Diabetes. Christopher D. Saudek, M.D., is Professor of Medicine at The Johns Hopkins University School of Medicine and a leader in the field of implantable pump therapy. Dr. Saudek began working on implantable insulin pump therapy with a predecessor of the Company in the early 1980's, implanted the first MiniMed pump in 1987 and was the principal investigator in the Company's clinical trials of its MIP 2001. Dr. Saudek received the Clinician of the Year Award from the ADA in 1991. Robert J. Tanenberg, M.D., FACP, is Clinical Associate Professor of Medicine at Georgetown University School of Medicine, Washington, D.C. and senior attending physician at Washington Hospital Center in Washington, D.C. Dr. Tanenberg is on the Medical Advisory Board for the Washington, DC Chapter of the Juvenile Diabetes Foundation. He is an investigator in the Company's implantable pump trials. Dr. Tannenberg was formerly the Chairman of the ADA's Council on Health Care Delivery and Public Health. ITEM 2. PROPERTIES The Company owns its current primary facilities with an aggregate of approximately 175,000 square feet in Sylmar, California. The Company currently occupies approximately 150,000 square feet of such facilities. The Company intends to use up to $2 million of the proceeds of a public offering of common stock contemplated by a recent Prospectus to upgrade the structure of its principal buildings in order to comply with recently adopted local building code requirements for earthquake protection. Approximately 23,400 square feet of the remaining space is leased to Alfred E. Mann, the Company's Chairman and Chief Executive Officer. The Company believes that its facilities are adequate to meet its foreseeable requirements for its existing products through at least the end of 1998, without any requirement to expand into additional space. ITEM 3. LEGAL PROCEEDINGS In September 1996, the Company filed an action against Fimed, Inc. ("Fimed") in Los Angeles County Superior Court seeking declaratory relief and rescission of a distributorship agreement giving Fimed an exclusive right to distribute the Company's external pumps using third-party consumer financing. The Company alleged that Fimed fraudulently induced the Company to enter into the agreement and failed to disclose material facts. Fimed answered the Company's complaint generally denying the allegations but also asserted counterclaims against the Company alleging breach of contract, promissory fraud, unfair competition, intentional interference with prospective economic advantage, defamation (libel and slander) and abuse of process and seeking compensatory damages of $600 million and punitive damages of $300 million. No significant amount of the Company's products has ever been sold using third-party consumer financing, and Fimed never made any sales under the agreement. The Company notified Fimed that the Company was seeking rescission of the agreement less than six months after it was signed and before Fimed began marketing the Company's products. The Company believes that it has meritorious defenses to the counterclaim asserted by Fimed. The Company intends to prosecute its claim against Fimed and defend against the counterclaim vigorously. Discovery has commenced in the litigation, but the matter has not yet been set for trial. The Company is not presently a party to any other material pending legal proceedings. The Company may be subject from time to time to various other legal proceedings, including product liability claims, which arise in the ordinary course of its business. The Company believes that none of such proceedings, individually or in the aggregate, are likely to have a material adverse effect on its business or financial condition. 22 23 ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS There were no matters submitted to a vote of the security holders of the Company, either through solicitation of proxies or otherwise, during the fourth quarter of the fiscal year ended December 27, 1996. EXECUTIVE OFFICERS OF THE REGISTRANT The Company's Executive Officers are generally elected annually by the Board of Directors for a one year term and serve at the pleasure of the Board. As of March 21, 1997, the Company's executive officers are:
NAME AGE POSITIONS WITH THE COMPANY - ------------------ --- -------------------------------------------------------- Alfred E. Mann 71 Chairman of the Board and Chief Executive Officer Terrance H. Gregg 48 President and Chief Operating Officer Eric S. Kentor 37 Senior Vice President, General Counsel and Secretary Kevin R. Sayer 39 Senior Vice President, Finance and Chief Financial Officer Clifford W. Hague 41 Vice President, Marketing and Business Development William Arthur 45 Vice President, Sales John H. Livingston 50 Vice President, Research, Development and Engineering Noory Shaolian 55 Vice President, Instrument Manufacturing and Service
Alfred E. Mann has served as Chairman of the Board and Chief Executive Officer of the Company since its incorporation and was President until 1994 and from October 1995 until October 1996. Until March 1994, Mr. Mann served as the Chairman of the Board of the General Partner of MMTL, a predecessor of the Company, which was also engaged in the design, manufacture and marketing of hospital intravenous pumps and electrostimulation devices primarily for restoration of hearing for the deaf. Mr. Mann has also served as Chairman of Advanced Bionics since 1994 and as CEO from 1994 to February 1996. Advanced Bionics is the successor to the electrostimulation business segment of MMTL. From 1985 to September 1992, Mr. Mann was also President and CEO of Siemens-Pacesetter, Inc., a manufacturer and distributor of cardiac pacemakers. Mr. Mann founded and from 1972 until 1985 was Chairman of the Board and CEO of Pacesetter Systems, Inc., a California corporation and predecessor of Siemens-Pacesetter, Inc. Prior to 1972, he was President of Spectrolab, an electro-optical and aerospace systems company, and Heliotek, a semiconductor and electro-optical components manufacturer, which companies Mr. Mann founded in 1956 and 1960, respectively, and which were sold to Textron Inc. in 1960. Mr. Mann is currently Chairman of the Board of Trustees of the Alfred E. Mann Foundation, a medical research foundation. Mr. Mann holds a B.A. and an M.S. degree in physics from the University of California, Los Angeles. Terrance H. Gregg was promoted to Executive Vice President, Operations in February 1996 and to President and Chief Operating Officer in October 1996. Mr. Gregg joined the Company as Vice President of Regulatory Affairs and Clinical Research in September 1994. Prior to employment with the Company, Mr. Gregg spent the preceding nine years as Vice President of Governmental Affairs for Ioptex Research, the ophthalmic surgical products subsidiary of Smith & Nephew, plc. Prior to joining Ioptex Research, Mr. Gregg was responsible for Regulatory Affairs, Clinical Research and Quality Assurance for divisions of Allergan, Inc. Mr. Gregg earned a B.S. degree in zoology from Colorado State University in 1971. Eric S. Kentor was promoted to Senior Vice President in February 1996. Mr. Kentor joined the Company in May 1995 as Vice President, General Counsel and Secretary. Prior to joining the Company, Mr. Kentor was Vice President, Legal Services, of Health Net, California's second largest health maintenance organization, where he held various positions beginning in March 1994. From March 1994 until May 1995, Mr. Kentor also served as Executive Counsel of Health Net's parent corporation, Health Systems International, Inc. Previously, from 1987 until 1994, Mr. Kentor practiced with the law firm of McDermott, Will & Emery, where he was elected partner in 1992. Mr. Kentor received a J.D. degree from the UCLA School of Law in 1986. Kevin R. Sayer was promoted to Senior Vice President, Finance, in February 1996. Mr. Sayer joined the Company in May 1994 as Vice President, Finance and Chief Financial Officer. Prior to joining the Company, 23 24 Mr. Sayer spent the previous 11 years with Ernst & Young, where he specialized in providing auditing, accounting and consulting services to high growth companies, primarily in the health care and high technology industry segments. Mr. Sayer received a B.S. in accounting from Brigham Young University in 1981 and received a Masters degree in accounting/information systems from Brigham Young University in 1983. William Arthur has served as Vice President, Sales, since March 1995. Previously Mr. Arthur served from July 1993 to February 1995 as the Company's Vice President, Sales and Marketing. He joined the Company in July 1993 after serving as President and CEO of Med-Fusion Inc., a subsidiary of Medex, Inc. and a manufacturer of ambulatory infusion pumps. Mr. Arthur founded Med-Fusion Inc. in 1984 and remained as its Chief Executive Officer after its acquisition by Medex in 1988. Prior to his employment with Med-Fusion, Mr. Arthur served as Director of Marketing for infusion systems for Pacesetter Systems, Inc. Previously Mr. Arthur served as Vice President of Sales and Marketing for Auto-Syringe, a subsidiary of Baxter International, an earlier competitor of a predecessor of the Company. Mr. Arthur received a B.S. degree in microbiology from Pennsylvania State University in 1973. Clifford W. Hague has served as Vice President, Marketing and Business Development, since March 1995. From February 1993 until March 1995, Mr. Hague was Vice President, Marketing and Clinical Research, of VIA Medical Corporation, an early-stage company developing a series of sensor systems primarily for hospital use. Previously, from October 1991 to January 1993, Mr. Hague served as Vice President, Marketing of Siemens Infusion Systems ("SIS") and before that, Director of Marketing of MiniMed Technologies, a predecessor of both SIS and the Company. Before joining MiniMed Technologies in January 1986, Mr. Hague was a product manager at Parker-Hannifin, Biomedical Division. Mr. Hague received an M.B.A. degree from the University of California, Irvine in 1983, and a B.S. degree in zoology from the University of California, Davis, in 1980. John H. Livingston has been Vice President, Research, Development and Engineering of the Company and its predecessors since May 1985. Mr. Livingston served as Director, Research, Development and Engineering at IMED Corporation from November 1983 until May 1985. From January 1978 until November 1983, Mr. Livingston worked at Cordis Corporation, where for the final two years he was Manager, Instrument and Software Design, for the Implantables Product Engineering Division, responsible for the design and development of electronic hardware and software for implantable medical electronic systems. Mr. Livingston received his B.S. degree in electrical engineering from Yale University and both an M.S. degree in electrical engineering and a J.M. degree from Stanford University in 1975. Noory Shaolian has been Vice President in charge of Instrument Manufacturing and Service since joining the Company in June 1992. From 1991 to June 1992, Mr. Shaolian pursued private real estate investments. Previously, from 1983 to 1991 he was Vice President of Manufacturing and Service at Mitsubishi Electronics, a manufacturer of personal and lap-top computers. Mr. Shaolian is a Certified Quality Engineer. His education includes a B.S. degree in mechanical engineering from California Polytechnic University, San Luis Obispo, and an M.S. degree in business administration from California State University at Los Angeles. 24 25 PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCK HOLDER MATTERS The Company's common stock commenced trading on the Nasdaq National Market, under the symbol "MNMD" on July 25, 1995. The following table sets forth, for the fiscal quarters indicated the intra-day high and low sales prices per share of the Company's common stock on the Nasdaq National Market.
HIGH LOW ------ ------ 1996 Fourth Quarter Ended December 27, 1996...................... $32.75 $23.50 Third Quarter Ended September 27, 1996...................... 29.75 18.25 Second Quarter Ended June 28, 1996.......................... 33.75 16.25 First Quarter Ended March 29, 1996.......................... 18.25 12.25 1995 Fourth Quarter Ended December 29, 1995...................... $13.38 $ 7.75 Third Quarter Ended September 29, 1995 (from July 25, 1995)..................................................... 13.50 8.75
RECORD HOLDERS As of March 19, 1997, the number of record holders of the Company's Common Stock was 275. DIVIDENDS The Company has never paid a cash dividend on its Common Stock. The Company currently anticipates that, for the foreseeable future, any earnings will be retained for use in its business and, accordingly, does not currently anticipate the payment of any cash dividends. The payment of dividends by the Company, if any, will be at the discretion of the Company's Board of Directors, and will depend upon the Company's earnings, financial position, capital requirements and such other factors as the Company's Board of Directors deems relevant. 25 26 ITEM 6. SELECTED CONSOLIDATED FINANCIAL DATA The following table summarizes certain selected consolidated financial data, which should be read in conjunction with the Company's financial statements and notes thereto included elsewhere herein and with "MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS." The selected consolidated financial data as of December 27, 1996, December 29, 1995 and December 31, 1994, 1993 and 1992, and for each of the five fiscal years in the period ended December 27, 1996 have been derived from the Company's audited financial statements, which have been audited by Deloitte & Touche LLP, the Company's independent auditors. Other information has been derived from other audited financial statements.
DATA OF PREDECESSOR ENTITIES(1) ----------- YEAR ENDED YEAR ENDED YEARS ENDED DECEMBER 31, DECEMBER 29, DECEMBER 27, --------------------------------- ------------- ------------- 1992 1993 1994 1995 1996 ----------- ------- --------- ------------- ------------- (IN THOUSANDS, EXCEPT PER SHARE DATA) STATEMENT OF OPERATIONS DATA: Net sales............................... $24,079 $31,731 $ 36,274 $ 45,107 $ 59,080 Cost of sales........................... 13,618 14,947 16,131 16,531 20,440 ------- ------- ------- ------- ------- Gross profit............................ 10,461 16,784 20,143 28,576 38,640 Operating expenses: Selling, general and administrative... 10,108 14,088 15,366 19,863 25,468 Research and development.............. 3,891 3,998 5,372 7,095 7,900 ------- ------- ------- ------- ------- Total.............................. 13,999 18,086 20,738 26,958 33,368 ------- ------- ------- ------- ------- Operating income (loss)................. (3,538) (1,302) (595) 1,618 5,272 Interest expense........................ (172) (410) (533) (352) -- Other income, including interest income................................ 29 154 228 965 1,062 ------- ------- ------- ------- ------- Income (loss) before income taxes ...... (3,681) (1,558) (900) 2,231 6,334 Provision for income taxes.............. -- -- -- 422 1,662 ======= ======= ======= ======= ======= Net income (loss)....................... $(3,681) $(1,558) $ (900) $ 1,809 $ 4,672 ======= ======= ======= ======= ======= Net income (loss) per share(2).......... $ (0.10) $ 0.17 $ 0.38 ======= ======= ======= Weighted average number of common and common equivalent shares used in computing net income (loss) per share(2).............................. 9,085,000 10,587,000 12,238,000(3) ======= ======= ======= BALANCE SHEET DATA: Working capital........................... $ 8,879 $ 9,026 $14,317 $ 32,695 $ 37,209 Total assets.............................. 16,998 19,068 24,510 52,529 59,503 Notes payable, net of current portion..... -- 7,286 7,000 -- -- Redeemable, convertible preferred stock... -- -- 8,513 -- -- Retained earnings (accumulated deficit)... -- (1,558) (2,962) (1,664) 3,008 Total stockholders' equity................ -- 4,005 2,022 42,362 49,626 Net assets................................ 5,563 -- -- -- --
- --------------- (1) The financial data presented for all periods subsequent to the Company's incorporation in 1993 reflect the operations of the medication infusion business of the Company as an independent entity. The financial data for 1992 reflect the operations of that business as a business unit within two limited partnerships as if the Company were a separate entity. (2) Pursuant to applicable rules, and because of the significant change in the Company's capital structure related to the conversion of preferred stock as a result of the Company's initial public offering of common 26 27 stock in 1995, per share information and weighted average shares outstanding are presented only for the three years in the period ended December 27, 1996. (3) Includes 1,456,146 shares of Common Stock issuable upon exercise of outstanding stock options with a weighted average exercise price of $7.81 per share. ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS GENERAL The Company has focused its efforts on three product lines: external pumps and related disposables, implantable insulin pumps and continuous glucose monitoring systems. There have been no sales of glucose monitoring systems to date. Sales activity of the implantable insulin pump, primarily in Europe, where the product is approved for commercial distribution, is in an early stage. RESULTS OF OPERATIONS The following table sets forth for the years indicated the percentage relationship to net sales of certain items in the Company's consolidated statements of operations and the percentage changes in the dollar amounts of such items on a comparative basis.
ANNUAL % INCREASE (DECREASE) PERCENTAGE OF NET SALES --------------------- ------------------------- 1995 1996 1994 1995 1996 VS. 1994 VS. 1995 ----- ----- ----- -------- -------- Net sales........................................ 100.0% 100.0% 100.0% 24.4% 31.0% Cost of sales.................................... 44.5 36.6 34.6 2.5 23.6 ----- ----- ----- ---- ----- Gross profit..................................... 55.5 63.4 65.4 41.9 35.2 Operating expenses: Selling, general and administrative............ 42.4 44.0 43.1 29.3 28.2 Research and development....................... 14.8 15.7 13.4 32.1 11.3 ----- ----- ----- ---- ----- Total operating expenses............... 57.2 59.7 56.5 29.9 23.8 ----- ----- ----- ---- ----- Operating income (loss).......................... (1.7)% 3.7% 8.9% -- 225.8% ===== ===== ===== ==== =====
27 28 NET SALES The following table sets forth domestic and international net sales, gross profits and research and development expenditures related to the Company's three primary product lines for the three years in the period ended December 27, 1996.
DOLLARS IN THOUSANDS % OF NET SALES ------------------------------- ------------------------- 1994 1995 1996 1994 1995 1996 ------- ------- ------- ----- ----- ----- NET SALES External pumps and related disposables Domestic........................... $29,980 $37,299 $50,688 82.6% 82.7% 85.8% International...................... 4,798 5,493 6,396 13.3 12.2 10.8 ------- ------- ------- ----- ----- ----- Subtotal................... $34,778 $42,792 $57,084 95.9 94.9 96.6 Implantable pumps Domestic........................... 233 151 -- 0.6% 0.3% -- International...................... 960 2,164 1,996 2.7 4.8 3.4 Subtotal................... 1,193 2,315 1,996 3.3 5.1 3.4 ------- ------- ------- ----- ----- ----- Other net sales...................... 303 -- -- 0.8 -- -- ------- ------- ------- ----- ----- ----- Total...................... $36,274 $45,107 $59,080 100.0% 100.0% 100.0% ======= ======= ======= ===== ===== ===== GROSS PROFITS External pumps and related disposables........................ $21,269 $28,017 $39,044 58.6% 62.1% 66.1% Implantable pumps.................... (1,429) 559 (404) (3.9) 1.3 (0.7) Other................................ 303 -- -- 0.8 -- -- ------- ------- ------- ----- ----- ----- Total...................... $20,143 $28,576 $38,640 55.5% 63.4% 65.4% ======= ======= ======= ===== ===== ===== RESEARCH AND DEVELOPMENT EXPENSES External pumps and related disposables........................ $ 1,355 $ 2,445 $ 3,381 3.7% 5.4% 5.8% Implantable pumps.................... 2,568 2,928 2,683 7.1 6.5 4.5 Glucose monitoring systems........... 1,449 1,722 1,836 4.0 3.8 3.1 ------- ------- ------- ----- ----- ----- Total...................... $ 5,372 $ 7,095 $ 7,900 14.8% 15.7% 13.4% ======= ======= ======= ===== ===== =====
FISCAL YEARS ENDED DECEMBER 27, 1996 AND DECEMBER 29, 1995 Net Sales. Net sales increased 31.0% in 1996 over 1995 to $59,080,000 from $45,107,000. This increase is principally the result of an increase of 33.4%, or $14,292,000, in the sales volume of external pumps and related disposables. Domestic sales of these products grew 35.9%, or $13,389,000, from 1995 to 1996, while international sales increased 16.4%, or $903,000. The domestic sales increase was primarily the result of increased sales volume of external pumps and related disposables, with external pump sales growing at a rate in excess of disposable product sales. Additionally, net sales increased due to a customer shift to more expensive disposable products (principally the Sof-set QR) offered by the Company since June 1995, with enhanced features and commensurately higher sales prices. With the introduction of the Company's new Model 507 insulin pump in June 1996, the domestic average sales prices on external pumps increased, while the related disposable products experienced relative price stability. International sales of external pumps and related disposables for 1996 and 1995 include the sale of external pumps to Novo Nordisk A/S, which previously manufactured an external insulin pump and related disposables that were sold in Europe. Under an agreement with the Company entered into in late 1993, the external insulin pumps that Novo Nordisk previously manufactured and sold were replaced with the Company's external insulin pumps. Sales of external pumps to Novo Nordisk represented 15.5% of international sales of external pumps and related disposables in 1996, while such sales represented 23.1% of international sales of these products in 1995. The decline in sales to Novo Nordisk in 1996 reflects the completion of the contractually determined delivery schedule with Novo Nordisk during the quarter ended June 28, 1996. 28 29 Sales of implantable pumps decreased by $319,000, or 13.8%, in 1996 over 1995. Due to problems encountered with the special insulin formulation manufactured by Hoechst and used in the implantable pump, such sales were limited during 1996. Although the Company received certification under the applicable directives issued by the EU and received the CE Mark in March 1995 for the implantable pump (permitting commercial sale throughout the EU), separate approval from the EU is required for commercial sale of the insulin. Hoechst, the manufacturer of that insulin, has applied for such approval. Such approval has not yet been received and no assurance can be given that such approval will be received. Future sales of the Company's implantable insulin pumps may be adversely affected by the lack of availability of the special insulin utilized in the implantable pump, as well as any delay or denial of regulatory approval for the insulin, seasonality, and overall market acceptance of this product line. The Company and Hoechst are continuing their testing of the special insulin for use in the implantable pump. No assurance can be given as to the potential for success of these efforts. If such efforts are not successful, the business, results of operations or financial condition of the Company could be materially adversely affected. In order for the implantable pump to be authorized for sale in the U.S., the Company must work with Hoechst under a procedure established by the FDA for approval of a combined application for the Company's pump and the Hoechst insulin. The Company has completed preparation of the PMA element of the application for the implantable pump and is assisting Hoechst in the preparation of the NDA element of the application for this special insulin. Delay or failure to obtain FDA approval could have a material adverse effect on the Company's business, results of operations or financial condition. See "BUSINESS -- Products -- Current Products -- Implantable Insulin Pump" and "BUSINESS -- Government Regulation." Cost of Sales and Operating Expenses. Cost of sales increased 23.6% in 1996 over 1995 to $20,440,000 from $16,531,000. As a percentage of net sales, cost of sales decreased to 34.6% in 1996 from 36.6% in 1995. Increased sales volume enabled the Company to spread its fixed manufacturing costs over a larger sales base and thereby achieve certain economies of scale. The Company has continued to implement manufacturing efficiency programs that reduced per unit labor, overhead and materials costs. Additionally, the Company achieved lower product costs for certain disposable products by bringing the manufacturing processes in-house during 1996. Cost of sales in 1996 included manufacturing start-up expenses related to the Company's June 1996 release of its latest generation external insulin pump, the Model 507. Gross margins on the external pumps and related disposables increased to 66.1% of sales in 1996, compared to 62.1% in 1995. The Company's gross profits have been adversely impacted by the implantable pump product line during 1996 due to continued unpredictable sales, which have inhibited the Company's ability to realize manufacturing efficiencies on this product line. The Company expects this trend to continue for the foreseeable future. Selling, general and administrative expenses increased 28.2% in 1996 over 1995 to $25,468,000 from $19,863,000. As a percentage of net sales, these expenses decreased to 43.1% in 1996 from 44.0% in 1995. Selling, general and administrative expenses increased primarily due to higher external pump and related disposable sales volume, the introduction of the Model 507 external insulin pump, increased efforts to educate patients, professionals and payors in the intensive management of diabetes, and increased spending in international sales and marketing operations. Increased international expenses related primarily to bringing in-house to the Company's French subsidiary certain administrative functions that had been previously performed by a third party and the organizational and continuing start-up costs of the Company's German subsidiary, which was formed in December 1995. Research and development expenses increased 11.3% in 1996 over 1995 to $7,900,000 from $7,095,000. As a percentage of sales, research and development expenses decreased to 13.4% in 1996 from 15.7% in 1995. The increase in expenses is primarily the result of greater resources directed to the design and introduction of the Company's Model 507 external insulin pump and increased development of the continuous glucose monitoring systems. Expenses related to the implantable insulin pump product line decreased in 1996, as the Company awaited approval of the special insulin required for this product. The Company anticipates that future research and development expenditures will include amounts for the further development of the Company's existing technologies for use in other medical conditions. 29 30 Other. Other income for 1996 and 1995 consists primarily of interest income generated from the Company's cash, cash equivalents, and short-term investment balances. The Company incurred interest expense in 1995 and 1994. No interest expense was incurred, however, during 1996 as all debt had been retired in connection with the Company's July 1995 initial public offering. The Company's effective tax rate for 1996 has been computed giving consideration to the pretax earnings and losses applicable to the Company's foreign and domestic tax jurisdictions and a continual decrease in the Company's valuation allowance against net deferred tax assets due to improved operating results. During 1995, the Company utilized all of its net operating loss carryforwards. The Company anticipates that future income tax rates for financial statement purposes will be lower than statutory state and federal income tax rates, as future income tax payments will be offset by the recognition of deferred income tax assets related to differences between financial reporting and income tax reporting requirements. The Company has not incurred any material foreign income tax expense to date. Inflation has not significantly impacted the Company's results of operations for the past three years. FISCAL YEARS ENDED DECEMBER 29, 1995 AND DECEMBER 31, 1994 Net Sales. Net sales increased 24.4% in 1995 over 1994 to $45,107,000 from $36,274,000. The 1995 growth in net sales of external pumps and related disposables amounted to $8,014,000, or 23.0%, over such sales in 1994 due to growth in both the domestic and international markets. Domestic sales of these products grew 24.4%, or $7,319,000, from 1994 to 1995, while international net sales increased 14.5%, or $695,000. The domestic net sales increase for 1995 resulted from increased sales volume of external pumps and related disposables, with disposable sales growing at a rate in excess of external pump sales. The effect of the increased sales volume achieved in 1995 was somewhat offset by lower average sales prices obtained on the sale of pumps. However, the related disposable products experienced a price increase during 1995. Domestic sales of external insulin pumps to previous pump users continued to decrease as a percentage of total domestic sales. As a result of this trend, the overall installed base of pump users increased at a faster rate than in prior periods. The 1995 international net sales increase was primarily the result of increased sales volume of pumps and related disposables to foreign distributors. The increase in international sales volume was partially offset by a scheduled decrease in sales under the Company's contract with Novo Nordisk. Sales of external insulin pumps to Novo Nordisk represented 23.1% of international sales of external pumps and related disposables in 1995, while such sales represented 47.1% of international sales of these products in 1994. Sales of implantable pumps increased by $1,122,000, or 94.0%, in 1995 over 1994. Due to problems encountered with the special insulin formulation manufactured by Hoechst and used in the implantable pump, such sales were limited to replacements for existing patients during the last half of 1994 and the first half of 1995. New patient implants for Europe slowly recommenced in the second half of 1995 when the Company received certification under the applicable directives issued by the EU and received the CE Mark in March 1995 for the implantable pump. Cost of Sales and Operating Expenses. Cost of sales increased 2.5% in 1995 over 1994 to $16,531,000 from $16,131,000. As a percentage of net sales, cost of sales in 1995 decreased to 36.6% from 44.5% in 1994. Increased sales volume enabled the Company to spread its fixed manufacturing costs over a larger sales base. Gross margins on the primary product line increased to 62.1% of sales in 1995, compared to 58.6% for this product line in 1994. Gross margins on the implantable pump product line were positive for 1995 due to the increased sales, compared to negative gross margins on the implantable pump in 1994. Selling, general and administrative expenses increased 29.3% in 1995 over 1994 to $19,863,000 from $15,366,000. As a percentage of net sales, these expenses increased to 44.0% in 1995 from 42.4% in 1994. Higher sales volume in 1995 was the most significant factor in the increase in selling expenses, primarily attributable to increased commissions and other variable costs related to the field sales force. Additional increases in selling expenses relate to the Company's increased focus upon training and education of patients, health care professionals and third party payors. General and administrative expenses also increased in 1995 over 1994. These increased costs related primarily to the development of the Company's accounting, finance, 30 31 MIS, legal and human resources departments to support the Company's growth and the requirements as a public reporting company. Research and development expenses increased 32.1% in 1995 over 1994 to $7,095,000 from $5,372,000. As a percentage of sales, research and development expenses increased to 15.7% in 1995 from 14.8% in 1994. The 1995 increase is primarily the result of greater resources directed to all of the Company's product lines. The Company increased research and development expenses related to the external pump and disposables to further the development of its next generation external insulin pump and several new disposable products. Increased research and development expenses were also incurred for the implantable pump and the continuous glucose monitoring systems. Other. Interest expense in 1994 and 1995 related to a $7,000,000 note payable retired in 1995 with proceeds from the Company's initial public offering. Other income in 1994 and 1995 related primarily to interest income generated from the Company's cash, cash equivalents, and short-term investments balances, with the 1995 increase related to increased funds available as a result of the initial public offering. LIQUIDITY AND CAPITAL RESOURCES During the years ended 1996 and 1995, the Company used cash in operations of $336,000 and $1,001,000, respectively. While the Company was profitable in both years, the Company's operating activities used cash, as receivables and inventories increased significantly. The receivables increase relates to several factors, including the extension of more favorable credit terms for some key distributors, increased sales to be reimbursed to the Company by third-party payors (which typically have longer collection cycles) and the overall sales volume increase. Because the Company experienced some product shortages during 1995, primarily related to its disposable products, the Company increased inventories in 1995 and 1996 to better serve its customers. The Company believes that maintaining increased inventories of these products and other key components will enable the Company to better meet customer demands. Expenditures on inventories have also increased in 1996 as a result of the Company's purchases of significant quantities of component parts for the implantable insulin pump under a supply agreement entered into in 1996. Capital expenditures were $1,713,000, $8,700,000 and $4,007,000 for 1994, 1995, and 1996 respectively. The Company's 1995 capital expenditures consisted primarily of the purchase and improvement of its operating facilities. The Company's 1996 capital expenditures included continued building improvements, manufacturing expansion, the acquisition of additional research and development engineering equipment and information systems requirements. The Company anticipates that future capital expenditures will increase because of required repairs and upgrades to its principal facility in compliance with recently enacted building code provisions applicable to earthquake protection. Capital expenditures will also increase due to the purchase of manufacturing and other equipment associated with expanding the Company's product lines and bringing more manufacturing in-house, as well as the purchase of additional information systems equipment. The Company completed its initial public offering of Common Stock in 1995 which generated net proceeds of $29.5 million. There were no significant equity transactions during 1996. On January 21, 1997, the Company entered into an unsecured line of credit agreement which enables the Company to borrow up to $10.0 million through January 31, 1999. The line of credit, if used, bears interest at an adjustable rate based upon certain commercial paper rates. The rate on such line of credit was 7.52% as of February 28, 1997. The Company is required to maintain certain cash, net worth and debt conditions under the provisions of the credit agreement. The Company is currently in compliance with all of these conditions. Management expects that the current level of cash and cash equivalents will be sufficient to meet its cash needs for working capital and capital expenditures for at least one year. However the requirements for additional capital and working capital are subject to change and will depend upon numerous factors, including the level of capital expenditures, research and development activities and results, competitive and technological developments, health care reimbursement trends, and the availability for acquisition by the Company of complementary additional distribution channels, products, and technologies. 31 32 The Company also is involved in certain litigation, the financial impact of which is uncertain. See "NOTES TO CONSOLIDATED FINANCIAL STATEMENTS" and "LEGAL PROCEEDINGS." QUARTERLY RESULTS The following table sets forth certain selected consolidated financial information of the Company for its eight most recent quarters. In the opinion of management, this unaudited financial information has been prepared on the same basis as the audited financial information, and includes all adjustments (consisting only of normal, recurring adjustments) necessary to present this information fairly when read in conjunction with the Company's Consolidated Financial Statements and Notes thereto contained elsewhere in this report.
THREE MONTHS ENDED --------------------------------------------------------------------------------------- MAR. 31, JUNE 30, SEPT. 29, DEC. 29, MAR. 29, JUNE 28, SEPT. 27, DEC. 27, 1995 1995 1995 1995 1996 1996 1996 1996 -------- -------- --------- -------- -------- -------- --------- -------- Net sales.......................... $8,301 $ 10,989 $ 11,007 $ 14,810 $ 12,209 $ 13,343 $ 14,709 $ 18,819 Cost of sales...................... 3,183 3,902 3,963 5,483 4,312 4,571 5,220 6,337 Gross profit....................... 5,118 7,087 7,044 9,327 7,897 8,772 9,489 12,482 Operating expenses: Selling, general and administrative................. 4,257 4,934 4,842 5,830 5,324 5,818 6,156 8,170 Research and development......... 1,369 2,005 1,700 2,021 1,822 1,953 1,896 2,229 ------ ------- ------- ------- ------- ------- ------- ------- Total operating expenses........... 5,626 6,939 6,542 7,851 7,146 7,771 8,052 10,399 Operating income (loss)............ $ (508) $ 148 $ 502 $ 1,476 $ 751 $ 1,001 $ 1,437 $ 2,083 ====== ======= ======= ======= ======= ======= ======= =======
The Company's results of operations have historically fluctuated on a quarterly basis. These seasonal trends have resulted in sales and earnings for each of the first three quarters of a given year being less than sales and earnings for the fourth quarter of the preceding year. These fluctuations have and will continue to result from numerous factors, including (i) practices of insurance companies and other third-party payors with respect to reimbursement for the Company's products, which tends to result in increased sales of the Company's external infusion pumps later in the calendar year, after patients' deductibles are satisfied, (ii) market acceptance of the Company's products, (iii) timing of regulatory approvals, (iv) new product introductions, (v) competition, (vi) the Company's ability to manufacture its products efficiently and (vii) timing of research and development expenditures. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA INDEX TO FINANCIAL STATEMENTS The following independent auditors' report and the consolidated financial statements of MiniMed Inc. and its subsidiaries are included in Item 8: Independent Auditors' Report Consolidated Balance Sheets -- December 29, 1995 and December 27, 1996 Consolidated Statements of Operations -- Years ended December 31, 1994, December 29, 1995 and December 27, 1996 Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity -- Years ended December 31, 1994, December 29, 1995 and December 27, 1996 Consolidated Statements of Cash Flows -- Years ended December 31, 1994, December 29, 1995 and December 27, 1996 Notes to Consolidated Financial Statements 32 33 INDEPENDENT AUDITOR'S REPORT To the Shareholders and Board of Directors of MiniMed Inc.: We have audited the accompanying balance sheets of MiniMed Inc. (the "Company") as of December 29, 1995 and December 27, 1996, and the related statements of operations, Convertible Preferred Stock and Stockholders' Equity, and of cash flows for each of the three years in the period ended December 27, 1996. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, such financial statements present fairly, in all material respects, the financial position of the Company as of December 29, 1995 and December 27, 1996, and the results of its operations and its cash flows for each of the three years in the period ended December 27, 1996 in conformity with generally accepted accounting principles. DELOITTE & TOUCHE LLP Woodland Hills, California January 17, 1997 (February 20, 1997 as to the last paragraph of note 3) 33 34 MINIMED INC. CONSOLIDATED BALANCE SHEETS DECEMBER 29, 1995 AND DECEMBER 27, 1996 ASSETS
1995 1996 ----------- ----------- CURRENT ASSETS: Cash and cash equivalents....................................... $14,762,000 $10,286,000 Short-term investments.......................................... 8,724,000 9,517,000 Accounts receivable, net of allowance for doubtful accounts of $1,327,000 and $2,575,000 in 1995 and 1996, respectively..... 10,562,000 15,617,000 Receivables due from related entities (Note 3).................. 23,000 90,000 Inventories: Raw materials................................................ 2,994,000 3,465,000 Work-in-process.............................................. 929,000 1,117,000 Finished goods............................................... 1,242,000 2,143,000 ----------- ----------- Total inventories....................................... 5,165,000 6,725,000 Deferred income taxes (Note 10)................................. 1,675,000 3,003,000 Prepaid expenses and other current assets....................... 1,065,000 1,042,000 ----------- ----------- Total current assets.................................... 41,976,000 46,280,000 OTHER ASSETS (Note 5)............................................. -- 577,000 LAND, BUILDINGS, PROPERTY AND EQUIPMENT -- Net (Note 4)........... 10,553,000 12,646,000 ----------- ----------- TOTAL............................................................. $52,529,000 $59,503,000 =========== =========== LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable................................................ $ 1,895,000 $ 1,642,000 Current portion of notes payable and line of credit (Note 6).... 600,000 -- Accrued salaries and related benefits........................... 1,352,000 2,065,000 Accrued sales commissions....................................... 614,000 1,568,000 Accrued warranties.............................................. 3,243,000 2,873,000 Income taxes payable (Note 10).................................. 532,000 463,000 Other accrued expenses.......................................... 1,045,000 460,000 ----------- ----------- Total current liabilities............................... 9,281,000 9,071,000 ----------- ----------- Deferred income taxes........................................... 886,000 806,000 COMMITMENTS AND CONTINGENCIES (Note 7) STOCKHOLDERS' EQUITY (Notes 1 and 8): Common stock, par value $.01; 20,000,000 shares authorized; 11,405,933 and 11,636,175 shares issued and outstanding in 1995 and 1996, respectively.................................. 114,000 116,000 Additional capital.............................................. 43,912,000 46,502,000 Retained earnings (Accumulated deficit)......................... (1,664,000) 3,008,000 ----------- ----------- Total stockholders' equity.............................. 42,362,000 49,626,000 ----------- ----------- TOTAL............................................................. $52,529,000 $59,503,000 =========== ===========
See notes to consolidated financial statements 34 35 MINIMED INC. CONSOLIDATED STATEMENTS OF OPERATIONS YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
YEAR ENDED ------------------------------------------- 1994 1995 1996 ----------- ----------- ----------- NET SALES........................................... $36,274,000 $45,107,000 $59,080,000 COST OF SALES....................................... 16,131,000 16,531,000 20,440,000 ----------- ----------- ----------- GROSS PROFIT........................................ 20,143,000 28,576,000 38,640,000 ----------- ----------- ----------- OPERATING EXPENSES: Selling, general and administrative............... 15,366,000 19,863,000 25,468,000 Research and development.......................... 5,372,000 7,095,000 7,900,000 ----------- ----------- ----------- Total operating expenses.................. 20,738,000 26,958,000 33,368,000 ----------- ----------- ----------- OPERATING INCOME (LOSS)............................. (595,000) 1,618,000 5,272,000 INTEREST EXPENSE.................................... (533,000) (352,000) -- OTHER INCOME, Including interest income............. 228,000 965,000 1,062,000 ----------- ----------- ----------- INCOME (LOSS) BEFORE INCOME TAXES................... (900,000) 2,231,000 6,334,000 PROVISION FOR INCOME TAXES (Note 10)................ -- 422,000 1,662,000 ----------- ----------- ----------- NET INCOME (LOSS)................................... $ (900,000) $ 1,809,000 $ 4,672,000 =========== =========== =========== NET INCOME (LOSS) PER SHARE (Note 2)................ $ (0.10) $ 0.17 $ 0.38 =========== =========== =========== WEIGHTED AVERAGE NUMBER OF COMMON AND COMMON EQUIVALENT SHARES USED IN COMPUTING NET INCOME (LOSS) PER SHARE (Note 2)......................... 9,085,000 10,587,000 12,238,000 =========== =========== ===========
See notes to consolidated financial statements 35 36 MINIMED INC. CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
REDEEMABLE CONVERTIBLE PREFERRED STOCK COMMON STOCK RETAINED ------------------------ --------------------- EARNINGS NUMBER OF NUMBER OF (ACCUMULATED SHARES AMOUNT SHARES AMOUNT CAPITAL DEFICIT) TOTAL ---------- ----------- ---------- -------- ----------- ----------- ----------- BALANCE, JANUARY 1, 1994.......... 7,805,478 $ 78,000 $ 5,485,000 $(1,558,000) $ 4,005,000 Issuance of preferred stock for technology (Note 3)................. 200,000 -- Issuance of preferred stock for cash, net of expenses................. 911,111 $ 8,009,000 Repurchase of treasury shares (Note 8).......... (75,703) (1,000) (578,000) (579,000) Accretion of preferred stock to redemption value.................... 212,000 (212,000) (212,000) Accrual of preferred stock dividends................ 292,000 (292,000) (292,000) Net loss................... (900,000) (900,000) ---------- ----------- ---------- -------- ----------- ---------- ----------- BALANCE, DECEMBER 31, 1994........ 1,111,111 8,513,000 7,729,775 77,000 4,907,000 (2,962,000) 2,022,000 Accretion of preferred stock to redemption value.................... 219,000 (219,000) (219,000) Accrual of preferred stock dividends................ 292,000 (292,000) (292,000) Issuance of common stock in initial public offering, net of expenses.......... 2,500,000 25,000 29,513,000 29,538,000 Conversion of redeemable convertible preferred.... (1,111,111) (9,024,000) 1,111,111 11,000 9,013,000 9,024,000 Exercise of stock options.................. 65,047 1,000 300,000 301,000 Tax benefit associated with stock option exercises... 179,000 179,000 Net income................. 1,809,000 1,809,000 ---------- ----------- ---------- -------- ----------- ---------- ----------- BALANCE, DECEMBER 29, 1995........ 11,405,933 114,000 43,912,000 (1,664,000) 42,362,000 Exercise of stock options.................. 203,020 2,000 986,000 988,000 Tax benefit associated with stock option exercises... 994,000 994,000 Issuance of stock under employee stock plan...... 14,822 272,000 272,000 Issuance of stock for technology license (Note 7)................. 10,000 285,000 285,000 Stock awards to directors................ 2,400 53,000 53,000 Net income................. 4,672,000 4,672,000 ---------- ----------- ---------- -------- ----------- ---------- ----------- BALANCE, DECEMBER 27, 1996........ -- -- 11,636,175 $116,000 $ 46,502,00 $ 3,008,000 $ 49,626,00 ========== =========== ========== ======== =========== ========== ===========
See notes to consolidated financial statements 36 37 MINIMED INC. CONSOLIDATED STATEMENTS OF CASH FLOWS YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996
1994 1995 1996 ----------- ----------- ----------- CASH FLOWS FROM OPERATING ACTIVITIES: Net income (loss)..................................... $ (900,000) $ 1,809,000 $ 4,672,000 Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: Depreciation.......................................... 760,000 1,365,000 1,914,000 Amortization of loan discount......................... 314,000 -- -- Deferred income taxes................................. -- (789,000) (1,408,000) Changes in operating assets and liabilities: Accounts receivable, net........................... 1,171,000 (2,795,000) (5,055,000) Receivables due from related entities.............. 233,000 101,000 (67,000) Inventories........................................ 2,091,000 (2,916,000) (1,560,000) Prepaid expenses and other current assets.......... (372,000) (261,000) 23,000 Other assets....................................... -- -- (300,000) Accounts payable................................... (1,425,000) 407,000 (253,000) Accrued sales commissions.......................... (375,000) 59,000 954,000 Accrued salaries and related benefits.............. 406,000 335,000 713,000 Accrued warranties................................. 549,000 360,000 (370,000) Other accrued expenses............................. (557,000) 792,000 470,000 Income taxes payable............................... -- 532,000 (69,000) ----------- ----------- ----------- Net cash provided by (used in) operating activities....................................... 1,895,000 (1,001,000) (336,000) ----------- ----------- ----------- CASH FLOWS FROM INVESTING ACTIVITIES: Short-term investments................................ -- (8,724,000) (793,000) Purchase of land, buildings, property and equipment... (1,713,000) (8,700,000) (4,007,000) ----------- ----------- ----------- Net cash used in investing activities.............. (1,713,000) (17,424,000) (4,800,000) ----------- ----------- ----------- CASH FLOWS FROM FINANCING ACTIVITIES: Repayment of note payable............................. -- (7,000,000) (600,000) Proceeds from issuance of preferred stock, net of expenses........................................... 8,009,000 -- -- Proceeds from initial public offering, net of expenses........................................... -- 29,538,000 -- Proceeds from stock option exercises.................. -- 301,000 988,000 Proceeds from issuance of common stock under employee stock plan......................................... -- -- 272,000 Repurchase of treasury shares......................... (579,000) -- -- ----------- ----------- ----------- Net cash provided by financing activities.......... 7,430,000 22,839,000 660,000 ----------- ----------- ----------- NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS.... 7,612,000 4,414,000 (4,476,000) CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD.......... 2,736,000 10,348,000 14,762,000 CASH AND CASH EQUIVALENTS, END OF PERIOD................ $10,348,000 $14,762,000 $10,286,000 =========== =========== =========== SUPPLEMENTAL CASH FLOW INFORMATION -- Cash paid during the period for: Interest........................................... $ 314,000 $ 361,000 -- Income taxes....................................... $ 1,000 $ 500,000 $ 1,866,000
SUPPLEMENTAL DISCLOSURE OF NONCASH FINANCING ACTIVITY -- During 1994 and 1995, the Company recorded $212,000 and $219,000, respectively in accretion of preferred stock to redemption value and $292,000 in accrued preferred stock dividends directly to accumulated deficit. The Company has recognized a reduction in income taxes payable of $179,000 and $994,000 during 1995 and 1996, respectively related to the exercise of nonqualified stock options. During 1996, the Company issued 10,000 shares of common stock with a value of $285,000 to a supplier in exchange for a license. The Company also issued 2,400 shares of Common Stock with a value of $53,000 to certain Directors in lieu of fees during 1996. See notes to consolidated financial statements 37 38 MINIMED INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996 1. GENERAL INFORMATION Operations -- MiniMed Inc. ("MiniMed" or the "Company") designs, develops, manufactures and markets medical devices for drug delivery and monitoring patients with diabetes and other medical conditions. The drug delivery systems include external and implantable microinfusion drug pumps and related disposable products which provide long-term delivery of medication for treatment of chronic disorders. The Company is developing glucose sensor systems which will, if successful, provide diabetic patients with continuous monitoring of glucose levels and may ultimately be linked to the microinfusion pumps to create an "artificial pancreas." Other development efforts focus on developing non-diabetes uses of the Company's technologies. 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation -- The accompanying financial statements include the accounts of the Company and its wholly owned subsidiaries MiniMed S.A. and MiniMed GmbH. All intercompany accounts and transactions have been eliminated. The financial statements of MiniMed S.A. and MiniMed GmbH have been translated using the exchange rate at the end of each period as to balance sheet items and the weighted average exchange rate during each period as to operating results. Translation and transaction gains and losses are immaterial for all periods presented. Cash and Cash Equivalents -- The Company considers all highly liquid instruments with an original maturity of three months or less to be cash equivalents. Short-term Investments -- In May 1993, the Financial Accounting Standards Board ("FASB") issued Statement of Financial Accounting Standards No 115, "Accounting for Certain Investments in Debt and Equity Securities," effective for fiscal years beginning after December 15, 1993. The Company has classified all of its debt securities as available-for-sale. For securities available-for-sale, unrealized gains and losses are recorded directly to stockholders' equity. As of December 29, 1995 and December 27, 1996, fair market value approximates cost for the investments held. Realized gains and losses are included in other income in the Company's statement of operations. Realized gains and losses on short-term investments for 1995 and 1996 were not material. The Company's investment policy is to invest idle and excess funds in high grade, short-term, fixed income securities. The primary objective of investment activities is to protect capital value. Inventories -- Inventories are stated at the lower of cost or market. Cost is determined using the first-in, first-out method. Land, Building, Property and Equipment and Depreciation -- Land, building, property and equipment are stated at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the related assets, which range from two to thirty-nine years. Research and Development -- Research and development costs are expensed as incurred. Net Income (Loss) per Common and Common Equivalent Share -- For the year ended December 27, 1996, net income per common and common equivalent share is computed based upon the weighted average number of shares of the Company's outstanding common stock and common stock equivalents, if dilutive. For the year ended December 29, 1995, net income per common and common equivalent share is computed based upon the weighted average number of shares of the Company's outstanding common stock and common stock equivalents, if dilutive, subsequent to the completion of the Company's initial public offering in July 1995. As required by rules promulgated by the Securities and Exchange Commission for 1994, shares, options, warrants and convertible preferred shares issued at prices below the initial public offering price of $13.00 in the twelve months prior to the initial public offering have been included in the calculation of weighted average common and common equivalent shares as if outstanding using the treasury stock method. 38 39 MINIMED INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996 Income Taxes -- Income taxes are provided for taxes currently payable or refundable, and deferred income taxes arising from future tax consequences of events that have been recognized in the Company's financial statements or tax returns. The effects of income taxes are measured based on enacted tax laws and rates. An allowance is provided for net deferred tax assets and tax loss carryforwards for which realization is not assured. Revenues and Concentration of Credit Risk -- During 1994, 1995 and 1996, the Company derived approximately 84%, 84% and 86%, respectively, of its revenues from domestic sales. Approximately 60%, 62% and 58%, respectively, of the Company's 1994, 1995 and 1996 domestic revenues were sales to distributors of medical products who sell the products directly to patients. The remaining domestic revenues represent products sold by the Company directly to patients. The Company bills these patients directly or processes billing to their health care payors, which include indemnity insurers, HMOs, PPOs and various state agencies. Certain distributor receivables are secured while all other receivables are unsecured. Foreign revenues in most countries represent sales to dealers in various countries in Europe. Sales to the European dealers may be shipped from the United States or through the Company's subsidiaries. Certain foreign sales are transacted directly by the Company's European subsidiaries with patients, with reimbursement provided by the appropriate third party payors in the appropriate country. Levels of payments from third-party payors and patients vary, depending upon the specific benefits provided under each patient's coverage. No single customer represents more than 10% of the Company's sales for any period presented. The Company has recorded an allowance for doubtful accounts to cover the difference between recorded revenues and collections from distributors, patients and third-party payors. The allowance and provision for bad debts are adjusted periodically based upon the Company's evaluation of historical collection experience, industry reimbursement trends and other relevant factors. Stock Based Compensation -- The Company has granted stock options for a fixed number of shares to employees with an exercise price equal to the fair market value of the shares at the date of grant. The Company accounts for stock option grants in accordance with APB Opinion No. 25, Accounting for Stock Issued to Employees, and, accordingly, recognizes no compensation expense for the stock option grants. Pervasiveness 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 certain assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. The Company's most significant estimates relate to the allowance for uncollectible accounts, provisions for inventory reserves and accrued warranties. Fiscal Year -- In fiscal 1995, the Company adopted a 4-4-5 accounting cycle with the fiscal year ending on the Friday closest to December 31. All prior years presented were based on the "calendar" year ended December 31. The Company's 1997 fiscal year end will be on January 2, 1997. Reclassifications -- Certain reclassifications have been made to the 1994 and 1995 financial statements to conform with the 1996 presentation. 3. RELATED PARTY TRANSACTIONS Services and Facilities Agreements -- During 1995 and 1994, the Company provided certain support services to and shared certain facilities and equipment with Advanced Bionics Corporation ("ABC"), a Company owned primarily by the individual who is currently the Company's largest single stockholder, Chairman and Chief Executive Officer. Costs charged to ABC were $470,000 and $180,000 for the years ended December 31, 1994 and December 29, 1995. ABC owed the Company $105,000 at December 31, 1994, $15,000 at December 29, 1995 and $90,000 at December 27, 1996. The amount owed by ABC to the 39 40 MINIMED INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996 Company at December 27, 1996 relates to equipment sold to ABC without a material gain or loss recognized. The Company has leased certain operating facilities to its current Chairman and Chief Executive Officer under a one-year lease renewable for four additional one year periods. In the event that the Chairman and Chief Executive Officer gives the Company a notice of non-renewal, he is obligated to pay the Company approximately $4,000 per month for improvements made to the facility through the earlier of June 2001 or the date the Company occupies the space. If the Company gives the Chairman and Chief Executive Officer a notice of non-renewal, neither he nor the Company has any further obligation. Rents charged under this agreement were $15,600 and $74,847 for the years ended December 29, 1995 and December 27, 1996, respectively. Rental income related to this lease is recorded in other income. Research and Development Costs and Purchase of Technology -- During the first six months of 1994, the Company performed research and development services for an entity owned by its Chairman, Chief Executive Officer, and largest single stockholder. The Company charged this affiliated entity $303,000 in 1994 for these research and development services. On June 22, 1994, the Company issued 200,000 shares of its redeemable, convertible preferred stock to this entity in exchange for certain technologies related to the development of a subcutaneous glucose sensor. As the Company purchased this technology from another entity which is considered an affiliate under rules and regulations of the Securities and Exchange Commission, the accounting basis of the technology transferred by the affiliate has been used to establish the value of the technology transferred as well as the preferred stock issued by the Company. The transferred technology had a $0 basis at the affiliate, as amounts related to the subcutaneous glucose sensor research had been recorded as research and development expense. Therefore, the Company assigned a $0 value to the technology acquired, and to the preferred stock issued, for this technology. These shares of preferred stock, along with all other outstanding shares of preferred stock, were converted to Common Stock in conjunction with the Company's initial public offering. On February 18, 1997, the Company's board of directors approved a mutual license and product improvement agreement between Medical Research Group, LLC ("MRG"), an entity controlled by the Company's Chief Executive Officer, and the Company. The final agreement has not yet been entered into. Under the proposed terms of this agreement, the Company will grant MRG a license to utilize certain MiniMed technology in the development of a diabetes treatment and management system (the "system") and will pay MRG royalties on MiniMed's sale of other products that may utilize improvements made by MRG to the MiniMed technology. MRG will grant MiniMed the option to purchase the marketing rights of the system for $30.0 million at the earlier of December 31, 1998 or 90 days after MRG achieves a pre-determined regulatory milestone in the development of the system (subject to extensions of the option period of up to one year under certain circumstances). In the event that MiniMed does not exercise its option to purchase these marketing rights, MRG may, at its option, purchase products and components from MiniMed at pre-determined transfer prices or may manufacture these products and pay royalties to MiniMed on the use of MiniMed's technology in the system. 40 41 MINIMED INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996 4. LAND, BUILDING, PROPERTY AND EQUIPMENT -- NET Land, building, property and equipment, net consists of the following:
DECEMBER 29, DECEMBER 27, USEFUL LIVES 1995 1996 (YEARS) ------------ ------------ ------------ Land, buildings and improvements....... $ 6,028,000 $ 7,058,000 39 to 40 Machinery and equipment................ 4,987,000 6,682,000 3 to 5 Tooling and molds...................... 2,299,000 2,979,000 3 Furniture and fixtures................. 1,131,000 1,733,000 7 ----------- ----------- 14,445,000 18,452,000 Less accumulated depreciation.......... (3,892,000) (5,806,000) ----------- ----------- Total.................................. $ 10,553,000 $ 12,646,000 =========== ===========
5. OTHER ASSETS Other assets consist of the following: Technology license (Note 7)............... $277,000 Inventory components, non-current (Note 7)................................ 300,000 -------- $577,000 ========
6. NOTES PAYABLE AND LINE OF CREDIT A customer advanced the Company $600,000 as part of a supply contract without interest, payable on demand. The loan was repaid during 1996. All other notes payable were retired with proceeds from the Company's initial public offering in July 1995. In January 1997, the Company entered into an unsecured line of credit agreement which expires on January 31, 1999. Under terms of this agreement, the Company may borrow up to $10.0 million and is required to pay monthly interest at a rate equal to the 30-day commercial paper rate plus 2.15%. MiniMed is also required to maintain certain cash, net worth and debt conditions under the provisions of this agreement. The Company is currently in compliance with all of these conditions. 7. COMMITMENTS AND CONTINGENCIES Rental expense under operating leases to non-related parties was $143,000, $212,000, and $0 for 1994, 1995, and 1996, respectively. On September 11, 1996, the Company filed a lawsuit against another company seeking rescission of a product distribution contract. Subsequent to the filing of this action, the other company has filed a counter-claim seeking compensatory damages of approximately $600 million and punitive damages of $300 million. The Company believes that it has meritorious defenses to the counterclaim asserted by Fimed. The Company intends to prosecute its claim against Fimed and defend against the counterclaim vigorously. Discovery has commenced in the litigation, but the matter has not yet been set for trial. On November 1, 1996, the Company entered into a material supply and technology license agreement with a supplier. The Company also issued 10,000 shares of common stock valued at $28.50 per share, the market value of the stock on the date of the agreement, to this supplier in exchange for the technology license. The Company is obligated to purchase component parts valued at $1,125,000 during fiscal 1997. On September 30, 1997, the Company has the option to purchase an additional $1,125,000 in components during 41 42 MINIMED INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996 fiscal 1998 or discontinue its purchasing activity with this supplier and utilize its technology license to develop a manufacturing operation to produce these components internally. The Company may also discontinue the utilization of these components in all the Company's products at September 30, 1997. In conjunction with the material supply and technology license agreement described above, the Company purchased component parts from this supplier during fiscal 1996 which will not be used in the sale of products in fiscal 1997 based upon planned sales levels derived from historical product demand. Accordingly, the Company has reclassified $300,000 of these component parts as a long-term asset included in other assets (Note 5). During the normal course of business, the Company is subject to litigation involving various business matters. Management believes that an adverse outcome of any such known matters would not have a material impact to the Company. 8. REDEEMABLE, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY Redeemable, Convertible Preferred Stock -- On June 22, 1994, the Company's Board of Directors authorized the issuance of a series of preferred stock of the Company, designated Series A Preferred Stock, and each share was convertible into one share of the Company's common stock at the option of the holder of the Series A Preferred Stock. The Company issued 1,111,111 shares of Series A Preferred Stock in 1994. All issued and outstanding shares of Series A Preferred Stock were automatically converted to common stock concurrent with the Company's initial public offering in July, 1995. An additional 3,899,999 shares of preferred stock are authorized and unissued as of December 27, 1996. Preferences, rights, and qualifications of the unissued but authorized preferred stock will be determined by the Board of Directors prior to the issuance of any additional shares of preferred stock. Treasury Stock -- On June 22, 1994, the Company's Board of Directors approved the repurchase of 75,703 shares of common stock from its Chairman and Chief Executive Officer for $700,000, of which $579,000 was recognized by the Company as treasury stock and $120,000 was recognized as compensation expense. Warrants -- In connection with the issuance of Series A Preferred Stock, which was converted to common stock in 1995, the Company issued warrants to purchase 200,000 shares of the Company's common stock at an exercise price of $13.00 per share to the holders of the Series A Preferred Stock. These warrants are exercisable at any time prior to June 22, 1997. Stock Options and Purchase Plan -- The Company has granted stock options under its Incentive Stock Plan ("stock option plan"), which provides that options may have a term of up to 10 years and become 42 43 MINIMED INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996 exercisable and vest in annual increments of up to six years. An additional 524,567 options are available for grant at December 27, 1996. Stock option plan activity is as follows:
RANGE OF OPTION PRICES PER SHARES SHARE --------- --------------- Outstanding options at January 1, 1994........... 880,850 $ 4.50 - $ 6.00 Options granted.................................. 184,250 $ 6.00 - $ 7.65 Options canceled................................. (78,550) --------- Outstanding options at December 31, 1994......... 986,550 ========= Options granted.................................. 543,500 $ 7.65 - $12.00 Options exercised................................ (65,047) $ 4.50 - $ 7.65 Options canceled................................. (38,035) --------- Outstanding options at December 29, 1995......... 1,426,968 ========= Options granted.................................. 303,847 $14.75 - $27.00 Options exercised................................ (203,020) $ 4.50 - $ 7.65 Options canceled................................. (71,649) --------- Outstanding options at December 27, 1996......... 1,456,146 $ 4.50 - $27.00 =========
The following table summarizes information about stock options outstanding at December 27, 1996:
NUMBER OUTSTANDING WEIGHTED AVERAGE WEIGHTED WEIGHTED RANGE OF AT DECEMBER 27, REMAINING AVERAGE SHARES EXERCISABLE AT AVERAGE EXERCISE PRICES 1996 CONTRACTUAL LIFE EXERCISE PRICE DECEMBER 27, 1996 EXERCISE PRICE - --------------------- ----------------- ---------------- -------------- --------------------- -------------- $4.50................ 422,546 4 $ 4.50 310,119 $ 4.50 $5.00 - $7.25........ 242,050 5 5.86 119.753 5.80 $7.65................ 490,800 6 7.65 110,100 7.65 $8.75 - $27.00....... 300,750 7 14.56 23,350 14.36 - --------- ------ ------- ------ 1,456,146 5 $ 7.81 563,322 $ 5.80 ========= = ====== ======= ======
During 1996, the Company's stockholders approved an employee stock purchase plan ("stock purchase plan"). Substantially all of the Company's employees are eligible to participate in the stock purchase plan through regular payroll deductions. Options under the stock purchase plan are granted for an indeterminable number of shares on semi-annual offering dates and are automatically exercised six months from the offering date, subject to employee withdrawal from the stock purchase plan. Options are exercised at the lesser of: (1) 85% of the fair market value of the common stock on the offering date (beginning of six month period); or (2) 85% of the fair market value of the common stock on the exercise date (end of six month period). Sale of shares issued under the stock purchase is prohibited for one year from the exercise date. Transactions related to the employee stock purchase plan are summarized as follows:
WEIGHTED AVERAGE SHARES EXERCISE PRICE --------- ---------------- Shares available................................. 1,000,000 Exercised........................................ 14,822 $18.38 --------- Shares available at December 27, 1996............ 985,178 =========
All stock options under the stock option plan are granted at the fair market value of the Company's common stock at the grant date. The weighted average estimated fair value of the stock purchase plan and options granted in 1995 and 1996 was $3,854,544 and $2,089,754, respectively. The Company applies 43 44 MINIMED INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996 Accounting Principles Board Opinion No. 25 and related Interpretations in accounting for its stock option plan and stock purchase plan. Accordingly, no compensation cost for the Company's stock option plan and stock purchase plan has been recognized in 1994, 1995 or 1996. Had compensation cost for the Company's stock option plan and stock purchase plan been determined based on the fair value at the grant dates for awards under those plans consistent with FASB Statement No. 123, Accounting for Stock Based Compensation, the Company's net income and earnings per share for the years ended December 29, 1995 and December 27, 1996 would have been reduced to the pro forma amounts indicated below:
YEARS ENDED --------------------------- DECEMBER DECEMBER 29, 27, 1995 1996 ----------- ----------- Net income: As reported....................................... $ 1,809,000 $ 4,672,000 Pro forma......................................... 1,157,000 3,812,000 Net income per common and common equivalent share: As reported....................................... $ 0.17 $ 0.38 Pro forma......................................... $ 0.11 $ 0.31
The fair value of options granted under the stock option plan during 1995 and 1996 was determined using the Black-Scholes option pricing model utilizing the following weighted-average assumptions:
YEARS ENDED ----------------------------- DECEMBER 29, DECEMBER 27, 1995 1996 ------------ ------------ Dividend yield..................................... 0% 0% Anticipated volatility............................. 325% 66% Risk-free interest rate............................ 7.40% 6.09% Expected lives..................................... 5 years 5 years
Pro forma compensation cost of options granted under the employee stock purchase plan is measured based upon the discount from market value. 9. EMPLOYEE BENEFIT PLAN The Company has a defined contribution plan which is available to substantially all full-time employees of the Company. No contributions were made during 1994. Subsequent to December 31, 1994, the Company revised the terms of the Plan. During 1995 and future periods, the Company is obligated to contribute a certain percentage of all employee contributions with limits specified by the Plan. Contributions to the Plan in the years ended December 29, 1995 and December 27, 1996 were $69,000 and $93,000, respectively. 10. INCOME TAXES Pretax income (loss) from continuing operations for the three years in the period ended December 27, 1996 was subject to income tax in the following jurisdictions:
YEAR ENDED ------------------------------------------ DECEMBER 31, DECEMBER 29, DECEMBER 27, 1994 1995 1996 ------------ ------------ ------------ Domestic.................................. $ (962,000) $2,208,000 $6,756,000 Foreign................................... 62,000 23,000 (422,000) --------- ---------- ---------- Pretax income (loss)...................... $ (900,000) $2,231,000 $6,334,000 ========= ========== ==========
44 45 MINIMED INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996 Significant components of the provision for income taxes are as follows:
YEAR ENDED ------------------------------------------ DECEMBER 31, DECEMBER 29, DECEMBER 27, 1994 1995 1996 ------------ ------------ ------------ Current: Federal................................. $ -- $ 812,000 $1,613,000 Foreign................................. -- -- 10,000 State................................... -- 220,000 453,000 ---------- ---------- ---------- -- $1,032,000 $2,076,000 Effect of nonqualified stock option exercises upon income taxes currently payable:................................ -- 179,000 994,000 Deferred Federal................................. -- (789,000) (1,100,000) Foreign................................. -- -- -- State................................... -- -- (308,000) ---------- ---------- ---------- -- (789,000) (1,408,000) ---------- ---------- ---------- $ -- $ 422,000 $1,662,000 ========== ========== ==========
The following table summarizes the changes in the Company's valuation allowance against deferred tax assets:
YEAR ENDED ----------------------------- DECEMBER 29, DECEMBER 27, 1995 1996 ------------ ------------ Beginning balance................................ $1,629,000 $1,268,000 Change........................................... (361,000) (653,000) ---------- ---------- Ending balance................................... $1,268,000 $ 615,000 ========== ==========
The components of deferred tax assets (liabilities) at December 29, 1995 and December 27, 1996 are as follows:
DECEMBER 29, 1995 DECEMBER 27, 1996 --------------------- --------------------- FEDERAL STATE FEDERAL STATE ---------- -------- ---------- -------- Deferred tax assets: Accrued warranties............... $1,137,000 $302,000 $1,006,000 $267,000 Accrued vacation................. 152,000 40,000 174,000 48,000 Allowance for doubtful accounts...................... 404,000 108,000 834,000 228,000 Inventory reserve................ 614,000 163,000 792,000 225,000 Other............................ 36,000 (13,000) 128,000 21,000 ---------- -------- ---------- -------- 2,343,000 600,000 2,934,000 789,000 Deferred tax liabilities: Depreciation..................... (700,000) (186,000) (633,000) (173,000) Deferred state income taxes...... (105,000) ---------- -------- ---------- -------- Net deferred tax assets............ 1,643,000 414,000 2,196,000 616,000 Valuation allowance................ (854,000) (414,000) (307,000) (308,000) ---------- -------- ---------- -------- Total.............................. $ 789,000 $ 0 $1,889,000 $308,000 ========== ======== ========== ========
45 46 MINIMED INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) YEARS ENDED DECEMBER 31, 1994, DECEMBER 29, 1995 AND DECEMBER 27, 1996 A reconciliation of the Company's provision for income taxes for 1995 and 1996 to the U.S. Federal Statutory rates is as follows:
YEAR ENDED ----------------------------- DECEMBER 29, DECEMBER 27, 1995 1996 ------------ ------------ Provision for income taxes at U.S. Statutory rates............. $716,000 $2,217,000 State taxes, net of Federal benefit............................ 134,000 94,000 Non-deductible expenses........................................ 107,000 112,000 Utilization of Federal and State operating loss carryforwards................................................ (201,000) Foreign loss not usable........................................ 148,000 Difference between actual rate and Federal Statutory rate...... (63,000) Reduction of valuation allowance............................... (361,000) (653,000) Other.......................................................... 27,000 (193,000) -------- ---------- $422,000 $1,662,000 ======== ==========
11. OPERATIONS BY GEOGRAPHIC AREA
YEAR ENDED ------------------------------------------ DECEMBER 31, DECEMBER 29, DECEMBER 27, 1994 1995 1996 ------------ ------------ ------------ NET SALES North American operations.......................... $ 33,283,000 $ 40,675,000 $ 53,569,000 European operations................................ 2,991,000 4,432,000 5,511,000 ------------ ------------ ------------ Consolidated....................................... $ 36,274,000 $ 45,107,000 $ 59,080,000 ========== ========== ========== OPERATING INCOME (LOSS) North American operations.......................... $ (617,000) $ 1,722,000 $ 5,526,000 European operations................................ 22,000 (104,000) (254,000) ------------ ------------ ------------ Consolidated....................................... $ (595,000) $ 1,618,000 $ 5,272,000 ========== ========== ========== IDENTIFIABLE ASSETS AT END OF PERIOD North American operations.......................... $ 22,954,000 $ 50,443,000 $ 56,026,000 European operations................................ 1,556,000 2,086,000 3,477,000 ------------ ------------ ------------ Consolidated....................................... $ 24,510,000 $ 52,529,000 $ 59,503,000 ========== ========== ==========
46 47 ITEM 9. CHANGES WITH AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. PART III ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT Information with respect to Directors and Executive Officers of the Company is incorporated by reference to the Company's definitive Proxy Statement for its annual meeting of shareholders to be filed not later than 120 days after December 27, 1996 with the Securities and Exchange Commission (the "1997 Proxy"). Certain information relating to Executive Officers of the Company appears in Part I of this Form 10-K and is incorporated in Part III by this reference. ITEM 11. EXECUTIVE COMPENSATION Information with respect to this item is incorporated by reference to the Company's 1997 Proxy. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT Information with respect to this item is incorporated by reference to the Company's 1997 Proxy. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS Information with respect to this item is incorporated by reference to the Company's 1997 Proxy. PART IV ITEM 14. EXHIBITS, FINANCIAL STATEMENTS, SCHEDULES, AND REPORTS ON FORM 8-K (a) 1. Financial Statements See index to financial statements under Item 8, on page 34 for a list of all financial statements filed as part of this report. 2. Financial statement schedules The following financial statement schedules are filed as a part of this Annual Report on Form 10-K: Schedule VII -- Valuation and Qualifying Accounts All other schedules are omitted because they are not applicable, not required, or because the required information is included in the consolidated financial statements or notes thereto. 3. Exhibits required to be filed by Item 601 of Regulation S-K The following exhibits are filed as part of this Annual Report on Form 10-K or are incorporated herein by reference: 2.1 Assignment and Assumption Agreement dated as of May 22, 1992 by and among Alfred E. Mann, Siemens-MiniMed Inc., Siemens Corporation, AEM MiniMed Corp., MiniMed Technologies Limited and Pacesetter Infusion, Inc. (included as Exhibit 2.1 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 2.2 Asset Acquisition Agreement dated March 18, 1993 by and between MiniMed Technologies Limited and MiniMed Inc. (included as Exhibit 2.2 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 47 48 3.1 Form of Restated Certificate of Incorporation of MiniMed Inc. (included as Exhibit 3.1 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 3.2 Bylaws of MiniMed Inc. (included as Exhibit 3.2 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 3.3 Amendment to Bylaws of MiniMed Inc. (included as Exhibit 3.3 to the Company's 1996 Annual Report on Form 10-K which is incorporated herein by reference). 3.4 Form of Stockholder Rights Agreement (included as Exhibit 3.4 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 3.5 Certificate of Designation with respect to Series B Preferred Stock (included as Exhibit 3.5 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference.) 4.1 Specimen certificate of Common Stock (included as Exhibit 4.1 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 10.1 General Principles of Cooperation dated as of December 17, 1992 by and between Novo Nordisk A/S and MiniMed Inc. (included as Exhibit 10.9 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 10.2 Term Sheet dated December 16, 1993 by and between Novo Nordisk A/S and MiniMed Inc. (included as Exhibit 10.10 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 10.3 Form of Class A Stock Purchase Warrant Expiring June 21, 1997 dated June 22, 1994 by and among MiniMed Inc. and Galen Partners II, L.P., Galen Partners International II, L.P. and Galen Employee Fund (included as Exhibit 10.14 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 10.4 MiniMed Technologies Limited Amended and Restated 1992 Option Plan (included as Exhibit 10.17 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 10.5 MiniMed Inc. 1992 Stock Incentive Plan -- Form of Option (included as Exhibit 4.4 to the Company's Registration Statement on Form S-8 (file no. 33-95630) which is incorporated herein by reference). 10.6 MiniMed Inc. Option Agreement -- Assumption of MiniMed Technologies Limited Options (included as Exhibit 10.18 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 10.7 MiniMed Inc. Second Amended and Restated 1994 Stock Incentive Plan (included as Exhibit 10.16 to the Company's 1996 Annual Report on Form 10-K which is incorporated herein by reference). 10.8 MiniMed Inc. 1994 Stock Incentive Plan -- Form of Option (included as Exhibit 10.20 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 10.9 License Agreement dated February 13, 1980, as amended December 10, 1990, by and between Applied Physics Laboratory of the Johns Hopkins University, Pacesetter Infusion, Ltd. and MiniMed Technologies Limited (included as Exhibit 10.24 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by 48 49 reference). (Certain redacted information in this Agreement has received confidential treatment.) 10.10 License Agreement dated as of October 1, 1993 by and between MiniMed Inc. and Wilson Greatbatch Ltd. (included as Exhibit 10.25 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 10.11 Supply Agreement dated as of October 1, 1993 by and between MiniMed Inc. and Wilson Greatbatch Ltd. (included as Exhibit 10.26 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 10.12 Amendment to Supply Agreement and License Agreement dated as of November 1, 1996 by and between MiniMed Inc. and Wilson Greatbatch Ltd. 10.13 Form of Indemnity Agreement between MiniMed Inc. and each of its officers and directors (included as Exhibit 10.27 to the Company's Registration Statement on Form S-1 (file no. 33-92710) which is incorporated herein by reference). 10.14 MiniMed Inc. Non-Employee Director Deferred Stock Units Plan (included as Exhibit 10.14 to the Company's 1996 Annual Report on Form 10-K which is incorporated herein by reference). 10.15 MiniMed Inc. Employee Stock Purchase Plan (included as Exhibit 10.15 to the Company's 1996 Annual Report on Form 10-K which is incorporated herein by reference). 10.16 WCMA Note and Loan Agreement dated as of January 21, 1997 by and between MiniMed Inc. and Merrill Lynch Business Financial Services Inc. 10.17 Lease dated as of August 1, 1995, as amended by Amendment thereto dated as of July 1, 1996, by and between MiniMed Inc. and Alfred E. Mann. 11.1 Statement relative to computation of per share earnings of the Company. 21.1 Subsidiaries of the Company. 23.1 Consent of Deloitte & Touche LLP. (b) 1. Reports on Form 8-K None were filed during the fourth quarter of 1996. 49 50 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, MiniMed Inc. has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized on March 25, 1997. MINIMED INC. Date: March 25, 1997 By: /s/ ALFRED E. MANN ------------------------------------ Alfred E. Mann Chairman of the Board and Chief Executive Officer (Principal Executive Officer) Date: March 25, 1997 By: /s/ KEVIN R. SAYER ------------------------------------ Kevin R. Sayer Senior Vice President, Finance and Chief Financial Officer (Principal Financial and Accounting Officer) Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Company and in the capacities indicated on March 25, 1997.
SIGNATURE TITLE DATE - ----------------------------------------------- --------------------------- --------------- /s/ ALFRED E. MANN Director, Chairman of the March 25, 1997 - ----------------------------------------------- Board and Chief Executive Alfred E. Mann Officer (Principal Executive Officer) /s/ KEVIN R. SAYER Senior Vice President, March 25, 1997 - ----------------------------------------------- Finance and Chief Financial Kevin R. Sayer Officer (Principal Financial and Accounting Officer) /s/ DAVID CHERNOF, M.D. Director March 25, 1997 - ----------------------------------------------- David Chernof, M.D. /s/ WILLIAM R. GRANT Director March 25, 1997 - ----------------------------------------------- William R. Grant /s/ DAVID MACCALLUM Director March 25, 1997 - ----------------------------------------------- David MacCallum /s/ THOMAS R. TESTMAN Director March 25, 1997 - ----------------------------------------------- Thomas R. Testman /s/ JOHN C. VILLFORTH Director March 25, 1997 - ----------------------------------------------- John C. Villforth
50 51 MINIMED INC. VALUATION AND QUALIFYING ACCOUNTS -- SCHEDULE VII
COLUMN A -- COLUMN B -- COLUMN C -- ADDITIONS COLUMN D-- COLUMN E-- --------------------------------- BALANCE AT (1) CHARGED TO (2) BALANCE BEGINNING CHARGED TO COSTS OTHER AT END DESCRIPTION OF PERIOD AND EXPENSES ACCOUNTS DEDUCTIONS OF PERIOD - --------------------------------- ----------- ---------------- -------------- ---------- ---------- Allowance for doubtful accounts: 1994........................ 1,149,000 1,168,000 (961,000) 1,356,000 1995........................ 1,356,000 391,000 (420,000) 1,327,000 1996........................ 1,327,000 1,750,000 (502,000) 2,575,000 Accrued warranties: 1994........................ 2,334,000 549,000 2,883,000 1995........................ 2,883,000 360,000 3,243,000 1996........................ 3,243,000 (370,000) 2,873,000
- --------------- (1) The allowance for doubtful accounts represents charges to bad debt expense for the year. (2) The allowance for doubtful accounts represents reductions of revenues for pricing adjustments, return estimates and bad debts. The accrued warranties reductions represent present lower warranty rates experienced in 1996. 51
EX-10.12 2 AMENDMENT TO SUPPLY AGREEMENT 1 EXHIBIT 10.12 [WILSON GREATBATCH LTD. LETTERHEAD] November 1, 1996 MiniMed Inc. 12744 San Fernando Road Sylmar, California 91342 Gentlemen: Reference is made to a certain Supply Agreement between you ("MMI") and MiniMed Technologies Ltd. ("MMT"), and Wilson Greatbatch Ltd. ("WGL), dated as of October 1, 1993 (the "Supply Agreement") and to a certain License Agreement between MMI and WGL, dated as of October 1, 1993 (the "License Agreement"). This letter is intended to set forth in writing certain amendments to the Supply Agreement and License Agreement, respectively, as set forth below: 1. Section 1.5 of the Supply Agreement is hereby amended to read in its entirety as follows: "1.5 Products. "Products" shall mean any medical device now or hereafter manufactured by or for MMI, including, without limitation, an Insulin Device." 2. Article 2 of the Supply Agreement is hereby amended to read in its entirety as follows: "ARTICLE 2 Purchase of Pumps 2.1 Purchase Orders and Term (a) Subject to all of the terms and conditions of this Agreement (including this amended Article 2), WGL and MMI agree to a three (3) year supply arrangement to be effective January 1, 1996 through December 31, 1998 ("Termination Date"). The initial Termination Date may be automatically extended by one year upon the delivery to WGL by MMI of a purchase order for not less than five hundred (500) 05 Pumps not later than September 1, 1996 (which order has been received); and for one additional year upon the delivery to WGL by MMI of a purchase order for not less than five hundred (500) 05 Pumps not later than September 1, 1997. Thereafter, any extension of the Termination Date of this Agreement shall only be by mutual written agreement. If MMI fails to submit a purchase order by September 1 of any year during the Term for at least five hundred (500) 05 Pumps for the following year of the Term, there shall be no extension of the Term of this Agreement beyond the balance of the then-current three-year term. In addition, WGL, at its sole discretion, may (x) reject any such Order for less than five hundred (500) 05 Pumps and give MMI notice that the supply obligation of WGL shall terminate after completing and delivering any Pumps remaining under then-accepted Orders, or (y) accept such Order and give MMI notice that the supply obligation of WGL shall terminate after completing such Order. 2 MiniMed, Inc. November 1, 1996 Page 2 (b) For purposes hereof, the word "Term" shall mean the initial three calendar years of 1996, 1997 and 1998, and any additional years resulting from an extension of the initial three-year period as provided for in Paragraph (a) above, subject to earlier termination as provided in said Paragraph (a) and elsewhere in this Agreement. (c) MMI has issued and delivered to WGL a written purchase order to purchase seven hundred and fifty (750) WGL 05 Pumps for delivery during the first year of the Term ("First Order"). The First Order is to be delivered in accordance with the delivery schedule set forth therein. MMI has also delivered a purchase order to purchase five hundred (500) WGL 05 Pumps for delivery during 1997, which order shall be delivered in accordance therewith. On or prior to each September 1 hereafter during the Term, MMI may deliver a purchase order for additional WGL 05 Pumps. For purposes of this Agreement, the term "Orders" shall mean, collectively, the First Order and all additional purchase orders submitted by MMI in accordance with the Agreement. Any term or condition contained in MMI's form purchase order(s) (or any amendment thereto) which is in addition to or conflicts or is inconsistent with this Agreement shall be null and void, and this Agreement shall be controlling in all respects. 2.2 Prices. (a) Subject to Paragraphs (b) through (d) of this Section 2.2, the purchase price for all WGL 05 Pumps during the Term shall be fifteen hundred dollars ($1,500) per pump unless the number of 05 Pumps ordered by MMI in any Order is less than seven hundred and fifty (750), in which case the price per pump shall be one thousand seven hundred and fifty dollars ($1,750). (b) If the Term of the Agreement is to extend beyond December 31, 1998, then WGL shall have the right to increase the price of all Pumps to be delivered after December 31, 1998 by an amount equal to the Base Prices multiplied by the percentage increase in the Consumer Price Index for the calendar month in which the Adjustment Date occurs over the Base CPI. WGL shall have the right to increase the Base Prices once only for each contract year; e.g., for Pumps sold in 1998, 1999, etc. (c) For purposes hereof: (i) "CPI Adjustment Date" shall mean June 1, 1998, June 1, 1999, and June 1 of each year thereafter to the extent that the Term shall have been extended. (ii) "Consumer Price Index" shall mean the Revised Consumer Price Index for Urban Wage Earners and Clerical Workers. All Items (base index year 1982-84=100), for Buffalo, New York, as published by the United States Department of Labor, Bureau of Labor Statistics. If the manner 3 MiniMed, Inc. November 1, 1996 Page 3 in which the Consumer Price Index is determined by the Bureau of Labor Statistics shall be substantially revised, including, without limitation, a change in the base index year, an adjustment shall be made by WGL in such revised index which would produce results equivalent, as nearly as possible, to those which would have been obtained if such Consumer Price Index had not been so revised. If the Consumer Price Index shall become unavailable to the public because publication is discontinued, or otherwise, or if equivalent data is not readily available to enable WGL to make the adjustment referred to in the preceding sentence, then WGL will substitute therefor a comparable index based upon charges in the cost of living or purchasing power of the consumer dollar published by another governmental agency or, if no such index shall be available, then a comparable index published by a major bank or other financial institution or by a university or recognized financial publication. (iii) "Base CPI" shall mean the Consumer Price Index for January, 1996. (iv) "Base Prices" shall mean the $1,750 and $1,500 prices set forth in Section 2.2(a) hereof. (d) WGL shall give notice to MMI of any CPI adjustment promptly after the CPI Adjustment Date and, in any event, at least 30 days prior to September 1 of 1998, September 1, 1999 and each September 1 thereafter to the extent that the Term shall have been extended, so that MMI can take any such adjustment into account in connection with placing its Orders under Section 2. 1. MMI shall have 30 days after receipt of a CPI notice to object to any proposed increase in the Base Prices. If MMI does object to any such increase within said period, MMI shall notify WGL in writing ("Objection") and, if the parties cannot mutually agree on any proposed increase to Base Prices hereunder within 30 days after WGL's receipt of any such objection, the parties shall submit their dispute to an independent certified public accounting firm whose decision shall be final and binding. Any decision that an increase to the Base Price is warranted shall be retroactive to the beginning of the contract year as to which the price increase applies. 2.3 No Modification of Order. (a) No Order shall be modified or cancelled. If MMI stops or refuses delivery of any Pumps covered by any Order prior to or on the applicable delivery date for the Pumps specified in the Order, then WGL shall invoice MMI for such Pumps on such date. 4 MiniMed, Inc. November 1, 1996 Page 4 (b) In the event MMI cancels any one of the Orders by written notice delivered to WGL, then WGL shall not be obligated to supply MMI with any further Pumps and may cancel this Agreement. MMI's purchase obligations are subject to WGL having sufficient batteries compatible with the 05 Pumps. WGL represents and warrants that it has available, and will retain solely for availability to MMI in accordance with this Agreement, aminimum of at least 3,000 batteries which are compatible with the 05 Pumps. 2.4 Quality. All Pumps covered by this Agreement will be manufactured under ISO 9001 system. WGL is certified to the standard British Standards Institute (BSI) certificate number FM 26911. 2.5 Terms. Shipping terms are FOB Clarence, New York, U.S.A. Payment terms are Net 30 days after shipment. 2.6 Continuing Supply. WGL and MiniMed shall in good faith discuss a continuing arrangement pursuant to which WGL would supply some Pumps for MMI as a second source of supply. If mutually agreed, the terms, conditions, price and time period for any such arrangement will be set forth in a written amendment to this Agreement or other written document, signed by both parties." 3. Article 7 of the Supply Agreement (as heretofore amended) is hereby further amended as follows: (i) The "Closing Date" as defined in Section 7.1 thereof is changed from October 15, 1995 to October 15, 1998; and (ii) The term "Technology Election Date" as defined in Section 7.2(a) thereof is changed from September 1, 1995 to September 1, 1998. If the initial Termination Date of this Agreement is extended by one year pursuant to Section 2.1(a) (as amended), and each time it is so extended, then the Closing Date and the Technology Election Date referred to above shall each also be extended by the same period of time. In addition, MMI agrees to deliver, to WGL, simultaneously with the execution of this letter agreement, the securities of MMI that comprise the License Fee (10,000 shares of common stock, $.01 par value, of MMI). In connection with such delivery, WGL hereby restates and reaffirms to MMI the representatives, warranties, acknowledgements and agreements appearing at Exhibit C to the License Agreement. 4. Section 8.3 of the Supply Agreement is amended as follows: 5 MiniMed, Inc. November 1, 1996 Page 5 (i) Paragraph (a) is deleted. (ii) Paragraph (b) is amended to change the introductory text of said paragraph to read in its entirety as follows: "MMI shall not be released from its obligations to pay for 05 Pumps covered by any Order placed under this Agreement in the event of a termination of this Agreement by WGL under Section 8.2(b) or under Section 8.2(a) if the termination under Section 8.2(a) is based on any of the following events:... " Clauses (i) through (iii) that follow the foregoing text shall not be changed. 5. The License Agreement is hereby amended as follows: (i) Section 1.1 of the License Agreement is amended to read in its entirety as follows: "1.1 Affiliate. "Affiliate" of any entity shall mean any other entity that directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, the first entity. Control shall mean owning more than thirty-four percent (34%) of the total voting power of the entity. (ii) Section 1.2 of the License Agreement is hereby amended to add a proviso at the end of said Section 1.2, after the word MMI, as follows: "; provided, however, that MMI shall not have any right or license to use, and the term "Know-How" shall not include, any information or know-how of WGL relating to Pumps which is developed by WGL after September 30, 1996, whether alone or jointly with any third party, unless such information or know-how (A) is directly used by WGL in manufacturing or producing Pumps which are purchased by MMI under the Supply Agreement or (B) is developed by WGL alone or jointly with MMI pursuant to a written order by MMI to develop improvements to the Pumps, which order shall have been acknowledged and accepted in writing by WGL." (iii) Section 1.5 of the License Agreement is amended to provide that "Pumps" shall include any 07 model Pump of WGL as well as 05 and 08 Pumps. 6 MiniMed, Inc. November 1, 1996 Page 6 (iv) Section 2.4(a) of the License Agreement is amended to read in its entirety as follows: "2.4 ADDITIONAL OBLIGATIONS AND CONSULTING AGREEMENT. (a) With respect to the Know How, WGL agrees to furnish MMI promptly after the execution of this Agreement, at WGL expense, copies of all documentation in written or tangible form which compromises Know-How hereunder that presently exists and was developed in the normal course of WGL's engineering and production. WGL further agrees to furnish to MMI promptly after the date of Closing (as defined in Section 6.2 hereof) any additional Know-How which is directly related to the manufacture of the Pumps theretofore purchased by MMI from WGL and which may exist as of such time (but subject to Section 1.2 as amended). In addition during the nine-month period beginning upon MMI's written notice thereof, which shall be given at least 60 days prior to the commencement of the Consulting Period but not later than 60 days prior to the Termination Date (as defined in the Supply Agreement), as extended (the "Consulting Period"), to the extent requested by MMI, WGL agrees to consult with and provide to MMI up to 90 eight-hour man days of support and training as to the Know How and the production of the Pumps, by WGL personnel having knowledge of the Know How. The first 30 eight-hour man days of such services during the Consulting Period shall be at no charge to MMI, and for the next 60 eight-hour man days MMI shall be charged $500 per man day except such charge shall be $1,000 per each man day of WGL's program manager. In addition, MMI shall promptly reimburse WGL for any travel and living expense incurred by WGL personnel in providing such services. The parties agree that WGL shall not be required to maintain its current Pump work force for purposes of this Section 2.4, and shall only be required to make available WGL personnel during the Consulting Period who are knowledgeable and experienced with the Know How and production of the Pumps. If the Initial Termination Date of this Agreement is extended by one year pursuant to Section 2. 1 (a) (as amended), and each time it is so extended, then the latest starting date for the Consulting Period shall also be extended by one year and shall run for a comparable 10-month period of time." (v) Section 3.1 of the License Agreement is hereby amended to provide that the Securities constituting the License Fee (in the form of 10,000 shares of the common stock of MiniMed, Inc.) are being issued and delivered to WGL simultaneously with the execution of this letter agreement. In connection with such delivery, WGL hereby restates and reaffirms to 7 MiniMed, Inc. November 1, 1996 Page 7 MMI the representatives, warranties, acknowledgements and agreements appearing at Exhibit C to the License Agreement. (vi) The "Royalty Date" as defined in Section 3.l(a) thereof is changed from December 31, 1999 to December 31, 2002. (vii) The date referred to in the first sentence of Section 5.1 thereof is changed from December 31, 1999 to December 31, 2002; The month referred to in Section 5.5(b)(iii) thereof shall continue to be July 1996; however, the "CPI Adjustment Date" as defined in Section 5.5(b)(i) thereof is changed to mean "July 1, 1997 and July 1 of each year thereafter through July 1, 2002"; and The date referred to in the first sentence of Section 5.6 thereof is changed from December 31, 1999 to December 31, 2002; PROVIDED, HOWEVER, that the date December 31, 2002, referred to in Sections 5.1, 5.5(b)(iii) and 5.6 of the Agreement (as hereby amended), shall be extended each and every time that the initial Termination Date of the Supply Agreement between WGL and MMI shall be extended and by the same period of time. (viii) Section 5.2 is hereby amended to substitute for the term "08 Pump" (in both places where it appears) the phrase "07 Pump or 08 Pump, as the case may be." (ix) Sections 6.1 and 6.2 are hereby amended to read in their entirety as follows: "6.1 MMI PURCHASE OF EQUIPMENT. MMI agrees to purchase subject to its inspection thereof at the time of Closing (as hereinafter defined), and WGL agrees to sell, certain equipment and tooling used by WGL in the manufacture of 05 Pumps. At least 10 days prior to Closing, WGL shall deliver to MMI a proposed list of the tooling and equipment to be sold to MMI, which list shall be mutually agreed upon prior to Closing (the "Equipment"). It is agreed that there shall be included in the Equipment which may be purchased at MMI's election: (A) one of the laser welders currently used by WGL in its pump motor assembly operation; and (B) fixtures and associated custom tooling that is used in the assembly of the 05 Pumps and that is unique to such Pump. The 8 MiniMed, Inc. November 1, 1996 Page 8 purchase price for the Equipment shall be determined in accordance with Section 6.4 (the "Purchase Price"). If WGL manufactures any 07 Pumps or 08 Pumps for MMI pursuant to the Supply Agreement, WGL will discuss with MMI the possible purchase by MMI of tooling and equipment used in connection with such manufacture; provided, however, that WGL shall not be obligated to sell any such tooling or equipment unless WGL and MMI enter into a further written agreement setting forth the specific assets to be sold and the terms and conditions of sale. 6.2 Closing. The consummation of the purchase and sale of the Equipment ("Closing") shall take place at WGL's offices in Clarence, New York at a time and on a date to be mutually agreed upon; provided, however, that (i) such date shall be the date on which WGL delivers the Equipment to MMI (subject to the WHERE IS condition of Section 6.3); and (ii) subject to clause (i) above, such date shall be no later than 30 days following the last date on which Pumps are manufactured by WGL for MMI. MMI may pay the Purchase Price in cash or by delivery of securities of MMI the number of which shall be in the same proportion to the number of Securities (as defined in and as to be delivered by MMI pursuant to Section 3.1 of this License Agreement) as the Purchase Price bears to $100,000." 5. The parties agree that MMT shall no longer be a party to the Supply Agreement or the License Agreement, and MMI shall be fully liable for all obligations of MMT, and shall have all rights of MMT, under both the Supply Agreement and the License Agreement. 6. Except as specifically provided in this Agreement, the Supply Agreement and License Agreement shall remain unchanged and in full force and effect. 9 MiniMed, Inc. November 1, 1996 Page 9 Please confirm you understanding and agreement to the foregoing by countersigning this letter agreement and returning one copy to the undersigned. Agreed to and Confirmed Agreed to and Confirmed as of the date of this letter. as of the date of this letter. MINIMED INC. WILSON GREATBATCH LTD. By TERENCE H. GREGG By EDWARD F. VOBORIL ----------------------------------- -------------------------------- Terrence H. Gregg, President/COO Edward F. Voboril, President/CE0 EX-10.16 3 WCMA NOTE & LOAN AGREEMENT 1 EXHIBIT 10.16 [MERRILL LYNCH LOGO] WCMA (R) NOTE AND LOAN AGREEMENT WCMA NOTE AND LOAN AGREEMENT ("Loan Agreement") dated as of January 6, 1997, between MINIMED INC. , a corporation organized and existing under the laws of the State of Delaware having its principal office at 12744 San Fernando Road, Sylmar, CA 91342 ("Customer"), and MERRILL LYNCH BUSINESS FINANCIAL SERVICES INC., a corporation organized and existing under the laws of the State of Delaware having its principal office at 33 West Monroe Street, Chicago, IL 60603 ("MLBFS"). In accordance with that certain WORKING CAPITAL MANAGEMENT (R) ACCOUNT AGREEMENT NO. 21C-07H08 ("WCMA Agreement") between Customer and MLBFS affiliate, MERRILL LYNCH, PIERCE, FENNER & SMITH INCORPORATED ("MLPF&S"), Customer has subscribed to the WCMA Program described in the WCMA Agreement. The WCMA Agreement is by this reference incorporated as a part hereof. In conjunction therewith and as part of the WCMA Program, Customer has requested that MLBFS provide, and subject to the terms and conditions herein set forth MLBFS has agreed to provide, a commercial line of credit for Customer (the "WCMA Line of Credit"). Accordingly, and in consideration of the premises and of the mutual covenants of the parties hereto, Customer and MLBFS hereby agree as follows: 1. DEFINITIONS (a) Specific Terms. In addition to terms defined elsewhere in this Loan Agreement, when used herein the following terms shall have the following meanings: (i) "Activation Date" shall mean the date upon which MLBFS shall cause the WCMA Line of Credit to be fully activated under MLPF&S' computer system as part of the WCMA Program. (ii) "Additional Agreements" shall mean all agreements, instruments, documents and opinions other than this Loan Agreement, whether with or from Customer or any other party, which are contemplated hereby or otherwise reasonably required by MLBFS in connection herewith, or which evidence the creation, guaranty or collateralization of any of the Obligations or the granting or perfection of liens or security interests upon any collateral for the Obligations. (iii) "Business Day" shall mean any day other than a Saturday, Sunday, federal holiday or other day on which the New York Stock Exchange is regularly closed. (iv) "Commitment Expiration Date" shall mean January 31, 1997. (v) "General Funding Conditions" shall mean each of the following conditions to any WCMA Loan by MLBFS hereunder: (A) no Event of Default, or event which with the giving of notice, passage of time, or both, would constitute an Event of Default, shall have occurred and be continuing or would result from the making of any WCMA Loan hereunder by MLBFS; (B) there shall not have occurred and be continuing any material adverse change in the business or financial condition of Customer; (C) all representations and warranties of Customer herein or in any Additional Agreements shall then be true and correct in all material respects; (D) MLBFS shall have received this Loan Agreement and all of the Additional Agreements, duly executed and filed or recorded where applicable, all of which shall be in form and substance reasonably satisfactory to MLBFS; and (E) any additional conditions specified in the "WCMA Line of Credit Approval" letter executed by MLBFS with respect to the transactions contemplated hereby shall have been met to the reasonable satisfaction of MLBFS. 2 (vi) "Interest Rate" shall mean a variable per annum rate of interest equal to the sum of 2.15% and the 30-Day Commercial Paper Rate. The "30-Day Commercial Paper Rate" shall mean, as of the date of any determination, the interest rate from time to time published in the "Money Rates" section of The Wall Street Journal for 30-day high-grade unsecured notes sold through dealers by major corporations. The Interest Rate will change as of the date of publication in The Wall Street Journal of a 30-Day Commercial Paper Rate that is different from that published on the preceding Business Day. In the event that The Wall Street Journal shall, for any reason, fail or cease to publish the 30-Day Commercial Paper Rate, MLBFS will choose a reasonably comparable index or source to use as the basis for the Interest Rate. (vii) "Line Fee" shall mean a fee of $25,000.00 ($12,500/year) payable to MLBFS in connection with the WCMA Line of Credit for the period from the Activation Date to the Maturity Date. (viii) "Maturity Date" shall mean January 31, 1999, or such later date as may be consented to in writing by MLBFS. (ix) "Maximum WCMA Line of Credit" shall mean $10,000,000.00. (x) "Obligations" shall mean all present and future liabilities, indebtedness and obligations of Customer under this Loan Agreement, including, without limitation, interest accruing after the filing of any petition in bankruptcy. (xi) "WCMA Account" shall mean and refer to the Working Capital Management Account of Customer with MLPF&S identified as Account No. 21C-07H08. (xii) "WCMA Loan" shall mean each advance made by MLBFS pursuant to this Loan Agreement. (b) Other Terms. Except as otherwise defined herein: (i) all terms used in this Loan Agreement which are defined in the Uniform Commercial Code of Illinois ("UCC") shall have the meanings set forth in the UCC, and (ii) capitalized terms used herein which are defined in the WCMA Agreement shall have the meaning set forth in the WCMA Agreement. 2. WCMA PROMISSORY NOTE FOR VALUE RECEIVED, Customer hereby promises to pay to the order of MLBFS, at the times and in the manner set forth in this Loan Agreement, or in such other manner and at such place as MLBFS may hereafter designate in writing, the following: (a) on the Maturity Date, the aggregate unpaid principal amount of all WCMA Loans (the "WCMA Loan Balance"); (b) interest at the Interest Rate on the outstanding WCMA Loan Balance, from and including the date on which the initial WCMA Loan is made until the date of payment of all WCMA Loans in full; and (c) on demand, all other sums payable pursuant to this Loan Agreement, including, but not limited to, the Line Fee and any late charges. Except as otherwise expressly set forth herein, Customer hereby waives presentment, demand for payment, protest and notice of protest, notice of dishonor, notice of acceleration, notice of intent to accelerate and all other notices and formalities in connection with this WCMA Promissory Note and this Loan Agreement. 3. WCMA LOANS (a) Activation Date. Provided that: (i) the Commitment Expiration Date shall not then have occurred, and (ii) Customer shall have subscribed to the WCMA Program and its subscription to the WCMA Program shall then be in effect, the Activation Date shall occur on or promptly after the date, following the acceptance of this Loan Agreement by MLBFS at its office in Chicago, Illinois, upon which each of the General Funding Conditions shall have been met or satisfied to the reasonable satisfaction of MLBFS. No activation by MLBFS of the WCMA Line of Credit for a nominal amount shall be deemed evidence of the satisfaction of any of the conditions herein set forth, or a waiver of any of the terms or conditions hereof. (b) WCMA Loans. Subject to the terms and conditions hereof, during the period from and after the Activation Date to the Maturity Date: (i) MLBFS will make WCMA Loans to Customer in such amounts as -2- 3 Customer may from time to time request in accordance with the terms hereof, up to an aggregate outstanding amount not to exceed the Maximum WCMA Line of Credit, and (ii) Customer may repay any WCMA Loans in whole or in part at any time without premium or penalty, and request a re-borrowing of amounts repaid on a revolving basis. Customer may request WCMA Loans by use of WCMA Checks, FTS, Visa (R) charges, wire transfers, or such other means of access to the WCMA Line of Credit as may be permitted by MLBFS from time to time; it being understood that so long as the WCMA Line of Credit shall be in effect, any charge or debit to the WCMA Account which but for the WCMA Line of Credit would under the terms of the WCMA Agreement result in an overdraft, shall be deemed a request by Customer for a WCMA Loan. (c) Conditions of WCMA Loans. Notwithstanding the foregoing, MLBFS shall not be obligated to make any WCMA Loan, and may without notice refuse to honor any such request by Customer, if at the time of receipt by MLBFS of Customer's request: (i) the making of such WCMA Loan would cause the Maximum WCMA Line of Credit to be exceeded: or (ii) the Maturity Date shall have occurred, or the WCMA Line of Credit shall have otherwise been terminated in accordance with the terms hereof; or (iii) Customers subscription to the WCMA Program shall have been terminated; or (iv) an event shall have occurred and is continuing which shall have caused any of the General Funding Conditions to not then be met or satisfied to the reasonable satisfaction of MLBFS. The making by MLBFS of any WCMA Loan at a time when any one or more of said conditions shall not have been met shall not in any event be construed as a waiver of said condition or conditions or of any Event of Default, and shall not prevent MLBFS at any time thereafter while any condition shall not have been met from refusing to honor any request by Customer for a WCMA Loan. (d) Force Majeure. MLBFS shall not be responsible, and shall have no liability to Customer or any other party, for any delay or failure of MLBFS to honor any request of Customer for a WCMA Loan or any other act or omission of MLBFS, MLPF&S or any of their affiliates due to or resulting from any system failure, error or delay in posting or other clerical error, loss of power, fire, Act of God or other cause beyond the reasonable control of MLBFS, MLPF&S or any of their affiliates unless directly arising out of the willful wrongful act or active gross negligence of MLBFS. In no event shall MLBFS be liable to Customer or any other party for any incidental or consequential damages arising from any act or omission by MLBFS, MLPF&S or any of their affiliates in connection with the WCMA Line of Credit or this Loan Agreement. (e) Interest. The WCMA Loan Balance shall bear interest at the Interest Rate. Interest shall be computed for the actual number of days elapsed on the basis of a year consisting of 360 days. Notwithstanding any provision to the contrary in this Agreement or any of the Additional Agreements, no provision of this Agreement or any of the Additional Agreements shall require the payment or permit the collection of any amount in excess of the maximum amount of interest permitted to be charged by law ("Excess Interest"). If any Excess Interest is provided for, or is adjudicated as being provided for, in this Agreement or any of the Additional Agreements, then: (a) Customer shall not be obligated to pay any Excess Interest; and (b) any Excess Interest that MLBFS may have received hereunder or under any of the Additional Agreements shall, at the option of MLBFS, be: (i) applied as a credit against the then unpaid balance of the WCMA Line of Credit, (ii) refunded to the payer thereof, or (iii) any combination of the foregoing. Except as otherwise provided herein, accrued and unpaid interest on the WCMA Loan Balance shall be payable monthly on the last Business Day of each calendar month, commencing with the last Business Day of the calendar month in which the Activation Date shall occur. Customer hereby irrevocably authorizes and directs MLPF&S to pay MLBFS such accrued interest from any available free credit balances in the WCMA Account, and if such available free credit balances are insufficient to satisfy any interest payment due, to liquidate any investments in the Money Accounts (other than any investments constituting any Minimum Money Accounts Balance under the WCMA Directed Reserve program) in an amount up to the balance of such accrued interest, and pay to MLBFS the available proceeds on account thereof. If available free credit balances in the WCMA Account and available proceeds of the Money Accounts are insufficient to pay the entire balance of accrued interest, and Customer otherwise fails to make such payment when due, MLBFS may, in its sole discretion, make a WCMA Loan in an amount equal to the balance of such accrued interest and pay the proceeds of such WCMA Loan to itself on account of such interest. The amount of any such WCMA Loan will be added to the WCMA Loan Balance. If MLBFS declines to extend a WCMA Loan to Customer under these circumstances, Customer hereby authorizes and directs MLPF&S to make all such interest payments to MLBFS from any Minimum Money Accounts Balance. If there is no Minimum Money Accounts Balance, or it is insufficient to pay all -3- 4 such interest, MLBFS will invoice Customer for payment of the balance of the accrued interest, and Customer shall pay such interest as directed by MLBFS within 5 Business Days of receipt of such invoice. (f) PAYMENTS. All payments required or permitted to be made pursuant to this Loan Agreement shall be made in lawful money of the United States. Unless otherwise directed by MLBFS, payments on account of the WCMA Loan Balance may be made by the delivery of checks (other than WCMA Checks), or by means of FTS or wire transfer of funds (other than funds from the WCMA Line of Credit) to MLPF&S for credit to Customers WCMA Account. Notwithstanding anything in the WCMA Agreement to the contrary, Customer hereby irrevocably authorizes and directs MLPF&S to apply available free credit balances in the WCMA Account to the repayment of the WCMA Loan Balance prior to application for any other purpose. Payments to MLBFS from funds in the WCMA Account shall be deemed to be made by Customer upon the same basis and schedule as funds are made available for investment in the Money Accounts in accordance with the terms of the WCMA Agreement. All funds received by MLBFS from MLPF&S pursuant to the aforesaid authorization shall be applied by MLBFS to repayment of the WCMA Loan Balance. The acceptance by or on behalf of MLBFS of a check or other payment for a lesser amount than shall be due from Customer, regardless of any endorsement or statement thereon or transmitted therewith, shall not be deemed an accord and satisfaction or anything other than a payment on account, and MLBFS or anyone acting on behalf of MLBFS may accept such check or other payment without prejudice to the rights of MLBFS to recover the balance actually due or to pursue any other remedy under this Loan Agreement or applicable law for such balance. All checks accepted by or on behalf of MLBFS in connection with the WCMA Line of Credit are subject to final collection. (g) EXCEEDING THE MAXIMUM WCMA LINE OF CREDIT. In the event that the WCMA Loan Balance shall at any time exceed the Maximum WCMA Line of Credit, Customer shall within 1 Business Day of the first to occur of (i) any request or demand of MLBFS, or (ii) receipt by Customer of a statement from MLPF&S showing a WCMA Loan Balance in excess of the Maximum WCMA Line of Credit, deposit sufficient funds into the WCMA Account to reduce the WCMA Loan Balance below the Maximum WCMA Line of Credit. (h) LINE FEE; EXTENSIONS. (i) In consideration of the extension of the WCMA Line of Credit by MLBFS to Customer during the period from the Activation Date to and including the last day of December in the year immediately following the year in which the Activation Date shall occur, Customer has paid or shall pay the initial Line Fee to MLBFS. If such fee has not heretofore been paid by Customer, Customer hereby authorizes MLBFS, at its option, to either cause said fee to be paid with a WCMA Loan which is added to the WCMA Loan Balance, or invoice Customer for said fee (in which event Customer shall pay said fee within 5 Business Days after receipt of such invoice). No delay in the Activation Date, howsoever caused, shall entitle Customer to any rebate or reduction in the Line Fee or extension of the Maturity Date. Customer shall pay an additional Line Fee for each 12-month period thereafter to the Maturity Date, and in connection therewith hereby authorizes MLBFS, at its option, to either cause each such additional Line Fee to be paid with a WCMA Loan which is added to the WCMA Loan Balance, or invoice Customer for such Line Fee, as aforesaid, on or at any time after the first Business Day of the first month of such 12-month period. (ii) In the event MLBFS and Customer, in their respective sole discretion, agree to renew the WCMA Line of Credit beyond the current Maturity Date, Customer agrees to pay a renewal Line Fee or Line Fees (if the Maturity Date is extended for more than one 24-month period), in the amount per 24-month period or other applicable period then set forth in the writing signed by MLBFS which extends the Maturity Date; it being understood that any request by Customer for a WCMA Loan or failure of Customer to pay any WCMA Loan Balance outstanding on the immediately prior Maturity Date, after the receipt by Customer of a writing signed by MLBFS extending the Maturity Date, shall be deemed a consent by Customer to both the renewal Line Fees and the new Maturity Date. If no renewal Line Fees are set forth in the writing signed by MLBFS extending the Maturity Date, the renewal Line Fee for each 24-month period shall be deemed to be the same as the immediately preceding periodic Line Fee. Each such renewal Line Fee may, at the option of MLBFS, either be paid with a WCMA Loan which is added to the WCMA Loan Balance or invoiced to Customer, as aforesaid, on or at any time after the first Business Day of the first month of the 24-month period for which such fee is due. (i) STATEMENTS. MLPF&S will include in each monthly statement it issues under the WCMA Program information with respect to WCMA Loans and the WCMA Loan Balance. Any questions that Customer may -4- 5 have with respect to such information should be directed to MLBFS; and any questions with respect to any other matter in such statements or about or affecting the WCMA Program should be directed to MLPF&S. (j) USE OF LOAN PROCEEDS; SECURITIES TRANSACTIONS. The proceeds of each WCMA Loan shall be used by Customer solely for general business purposes in the ordinary course of its business, or, with the prior written consent of MLBFS, for other lawful business purposes of Customer not prohibited hereby. CUSTOMER AGREES THAT UNDER NO CIRCUMSTANCES WILL FUNDS BORROWED FROM MLBFS THROUGH THE WCMA LINE OF CREDIT BE USED: (i) FOR PERSONAL, FAMILY OR HOUSEHOLD PURPOSES OF ANY PERSON WHATSOEVER, OR (ii) TO DIRECTLY OR INDIRECTLY PURCHASE, CARRY OR TRADE IN SECURITIES, OR REPAY DEBT INCURRED TO PURCHASE, CARRY OR TRADE IN SECURITIES, WHETHER IN OR IN CONNECTION WITH THE WCMA ACCOUNT, ANOTHER ACCOUNT OF CUSTOMER WITH MLPF&S OR AN ACCOUNT OF CUSTOMER AT ANY OTHER BROKER OR DEALER IN SECURITIES. 4. REPRESENTATIONS AND WARRANTIES Customer represents and warrants to MLBFS that: (a) ORGANIZATION AND EXISTENCE. Customer is a corporation, duly organized and validly existing in good standing under the laws of the State of Delaware and is qualified to do business and in good standing in each other state where the nature of its business or the property owned by it make such qualification necessary. (b) EXECUTION, DELIVERY AND PERFORMANCE. The execution, delivery and performance by Customer of this Loan Agreement and such of the Additional Agreements to which it is a party: (i) have been duly authorized by all requisite action, (ii) do not and will not violate or conflict with any law or other governmental requirement, or any of the agreements, instruments or documents which formed or govern Customer, and (iii) do not and will not breach or violate any of the provisions of, and will not result in a default by Customer under, any other agreement, instrument or document to which it is a party or by which it or its properties are bound. (c) NOTICES AND APPROVALS. Except as may have been given or obtained, no notice to or consent or approval of any governmental body or authority or other third party whatsoever (including, without limitation, any other creditor) is required in connection with the execution, delivery or performance by Customer of such of this Loan Agreement and the Additional Agreements to which it is a party. (d) ENFORCEABILITY. This Loan Agreement and such of the Additional Agreements to which it is a party are the legal, valid and binding obligations of Customer, enforceable against it in accordance with their respective terms, except as enforceability may be limited by bankruptcy and other similar laws affecting the rights of creditors generally or by general principles of equity. (e) FINANCIAL STATEMENTS. Except as expressly set forth in Customer's financial statements, all financial statements of Customer furnished to MLBFS have been prepared in conformity with generally accepted accounting principles, consistently applied, are true and correct, and fairly present the financial condition of it as at such dates and the results of its operations for the periods then ended; and since the most recent date covered by such financial statements, there has been no material adverse change in any such financial condition or operation. (f) LITIGATION. Except as disclosed in Customer's Quarterly Report on Form 10-Q for the quarter ending September 27, 1996, no litigation, arbitration, administrative or governmental proceedings are pending or, to the knowledge of Customer, threatened against Customer, which would, if adversely determined, materially and adversely affect the liens and security interests of MLBFS hereunder or under any of the Additional Agreements, the financial condition of Customer or the continued operations of Customer. (g) TAX RETURNS. All federal, state and local tax returns, reports and statements required to be filed by Customer have been filed with the appropriate governmental agencies and all taxes due and payable by Customer have been timely paid (except to the extent that any such failure to file or pay will not materially -5- 6 and adversely affect either the liens and security interests of MLBFS hereunder or under any of the Additional Agreements, the financial condition of Customer, or the continued operations of Customer). Each of the foregoing representations and warranties: (i) has been relied upon as an inducement to MLBFS to provide the WCMA Line of Credit, and (ii) is continuing and shall be deemed remade by Customer concurrently with each request for a WCMA Loan. 5. FINANCIAL AND OTHER INFORMATION Customer shall furnish or cause to be furnished to MLBFS during the term of this Loan Agreement all of the following: (a) ANNUAL FINANCIAL STATEMENTS. Within 120 days after the close of each fiscal year of Customer, Customer shall furnish or cause to be furnished to MLBFS a copy of the annual audited financial statements of Customer consisting of at least a balance sheet as at the close of such fiscal year and related statements of income, retained earnings and cash flows, certified by its current independent certified public accountants or other independent certified public accountants reasonably acceptable to MLBFS. (b) INTERIM FINANCIAL STATEMENTS. Within 45 days after the close of each fiscal quarter of Customer, Customer shall furnish or cause to be furnished to MLBFS: (i) a statement of profit and loss for the fiscal quarter then ended, and (ii) a balance sheet as at the close of such fiscal quarter; all in reasonable detail and certified by its chief financial officer. (c) AGING OF ACCOUNTS. Within 45 days after the close of each fiscal quarter of Customer, Customer shall furnish or cause to be furnished to MLBFS an aging of its Accounts and any Chattel Paper, certified by its chief financial officer. (d) OTHER INFORMATION. Customer shall furnish or cause to be furnished to MLBFS such other information as MLBFS may from time to time reasonably request relating to Customer. 6. OTHER COVENANTS Customer further agrees during the term of this Loan Agreement that: (a) FINANCIAL RECORDS; INSPECTION. Customer will: (i) maintain at its principal place of business complete and accurate books and records, and maintain all of its financial records in a manner consistent with the financial statements heretofore furnished to MLBFS, or prepared on such other basis as may be approved in writing by MLBFS; and (ii) permit MLBFS or its duly authorized representatives, upon reasonable notice and at reasonable times, to inspect its properties (both real or personal), operations, books and records. (b) TAXES. Customer will pay when due all taxes, assessments and other governmental charges, howsoever designated, and all other liabilities and obligations, except to the extent that any such failure to pay will not materially and adversely affect either any liens and security interests of MLBFS under any Additional Agreements, the financial condition of Customer or the continued operations of Customer. (c) COMPLIANCE WITH LAWS AND AGREEMENTS. Customer will not violate any law, regulation or other governmental requirement, any judgment or order of any court or governmental agency or authority, or any agreement, instrument or document to which it is a party or by which it is bound, if any such violation will materially and adversely affect either any liens and security interests of MLBFS under any Additional Agreements, or the financial condition or the continued operations of Customer. (d) NOTIFICATION BY CUSTOMER. Customer shall provide MLBFS with prompt written notification of: (i) any Event of Default, or event which with the giving of notice, passage of time, or both, would constitute an Event of Default; (ii) any materially adverse change in the business, financial condition or operations of Customer; and (iii) any information which indicates that any financial statements of Customer fail in any material respect to present fairly the financial condition and results of operations purported to be presented -6- 7 in such statements. Each notification by Customer pursuant hereto shall specify the event or information causing such notification, and, to the extent applicable, shall specify the steps being taken to rectify or remedy such event or information. (e) Continuity. Except upon the prior written consent of MLBFS, which consent will not be unreasonably withheld: (i) Customer will not be a party to any merger or consolidation with, or purchase or otherwise acquire all or substantially all of the assets or stock of, or any material partnership or joint venture interest in, any person or entity, or sell, transfer or lease all or any substantial part of its assets if any such action causes a material change in its control or principal business, or a material adverse change in its financial condition or operations; (ii) Customer will preserve its existence and good standing in the jurisdictions of establishment and operation, and will not operate in any material business other than a business substantially the same as its business as of the date of application by Customer for credit from MLBFS, and (iii) Customer will not cause or permit any material change in its controlling ownership, controlling senior management or, except upon not less than 30 days prior written notice to MLBFS, its name or principal place of business. (f) Tangible Net Worth. The "tangible net worth" of Customer, consisting of Customers net worth as shown on Customer's regular financial statements prepared in a manner consistent with the terms hereof, but excluding an amount equal to: (i) any assets which are ordinarily classified as "intangible" in accordance with generally accepted accounting principles, and (ii) any amounts now or hereafter directly or indirectly owing to Customer by officers, shareholders or affiliates of Customer, shall at all times exceed $35,000,000.00. (g) Debt to Worth. The ratio of Customer's total debt to Customers tangible net worth, determined as aforesaid, shall not at any time exceed 0.6 to 1. (h) Minimum Cash Flow. The "Annualized Net Cash Flow" of Customer as of the end of each of its fiscal quarters shall not be less than $2,000,000.00. As used herein, "Annualized Net Cash Flow" shall mean, as of the end of any fiscal quarter of Customer, the excess of (i) the sum of Customer's net after-tax income and depreciation for the immediately preceding four fiscal quarters of Customer, over (ii) the sum of the then current portion of long term debt and all dividends and other distributions to shareholders in the immediately preceding four fiscal quarters; all as shown on Customer's regular financial statements prepared in a manner consistent with the terms hereof. (i) Negative Pledge. Except upon the prior written consent of MLBFS, Customer shall not directly or indirectly mortgage, encumber, pledge or grant a lien or security interest in any of its assets or property, now owned or hereafter acquired other than: (i) liens for current taxes not delinquent or being contested in good faith by appropriate proceedings, (ii) other non-consensual liens arising in the ordinary course of business for sums not due, (iii) purchase money liens upon and leases of equipment, and (iv) liens in favor of MLBFS. 7. EVENTS OF DEFAULT The occurrence of any of the following events shall constitute an "Event of Default' under this Loan Agreement: (a) Failure to Pay. Customer shall fail to pay to MLBFS or deposit into the WCMA Account when due any amount owing or required to be paid or deposited by Customer under this Loan Agreement, or shall fail to pay when due any other Obligations, and any such failure shall continue for more than 5 Business Days after written notice thereof shall have been given by MLBFS to Customer. (b) Failure to Perform. Customer shall default in the performance or observance of any covenant or agreement on its part to be performed or observed under this Loan Agreement or any of the Additional Agreements (not constituting an Event of Default under any other clause of this Section), and such default shall continue unremedied for 10 Business Days after written notice thereof shall have been given by MLBFS to Customer, -7- 8 (c) Breach of Warranty. Any representation or warranty made by Customer contained in this Loan Agreement or any of the Additional Agreements shall at any time prove to have been incorrect in any material respect when made. (d) Default Under Other Agreement. A default or Event of Default by Customer or any other party providing collateral for the Obligations shall occur under the terms of any other agreement, instrument or document with or intended for the benefit of MLBFS, MLPF&S or any of their affiliates involving in the case of indebtedness owned to a party other than MLBFS, indebtedness of $500,000.00 or more, and any required notice shall have been given and required passage of time shall have elapsed. (e) Bankruptcy, Etc. A proceeding under any bankruptcy, reorganization, arrangement, insolvency, readjustment of debt or receivership law or statute shall be filed by Customer, or any such proceeding shall be filed against Customer and shall not be dismissed or withdrawn within 60 days after filing, or Customer shall make an assignment for the benefit of creditors, or Customer shall become insolvent or generally fail to pay, or admit in writing its inability to pay, its debts as they become due. (f) Material Impairment. Any event shall occur which shall reasonably cause MLBFS to in good faith believe that the prospect of payment or performance by Customer has been materially impaired. (g) Acceleration of Debt to Other Creditors. Any event shall occur which results in the acceleration of the maturity of any indebtedness of $500,000.00 or more of Customer to another creditor under any indenture, agreement, undertaking, or otherwise. 8. REMEDIES (a) Remedies Upon Default. Upon the occurrence and during the continuance of any Event of Default, MLBFS may at its sole option do any one or more or all of the following, at such time and in such order as MLBFS may in its sole discretion choose: (i) Termination. MLBFS may without notice terminate the WCMA Line of Credit and all obligations to provide the WCMA Line of Credit or otherwise extend any credit to or for the benefit of Customer; and upon any such termination MLBFS shall be relieved of all such obligations. (ii) Acceleration. MLBFS may declare the principal of and interest on the WCMA Loan Balance, and all other Obligations to be forthwith due and payable, whereupon all such amounts shall be immediately due and payable, without presentment, demand for payment, protest and notice of protest, notice of dishonor, notice of acceleration, notice of intent to accelerate or other notice or formality of any kind, all of which are hereby expressly waived. (b) Remedies are Severable and Cumulative. All rights and remedies of MLBFS herein are severable and cumulative and in addition to all other rights and remedies available in the Additional Agreements, at law or in equity, and any one or more of such rights and remedies may be exercised simultaneously or successively. 9. MISCELLANEOUS (a) Non-Waiver. No failure or delay on the part of MLBFS in exercising any right, power or remedy pursuant to this Loan Agreement or any of the Additional Agreements shall operate as a waiver thereof, and no single or partial exercise of any such right, power or remedy shall preclude any other or further exercise thereof, or the exercise of any other right, power or remedy. Neither any waiver of any provision of this Loan Agreement or any of the Additional Agreements, nor any consent to any departure by Customer therefrom, shall be effective unless the same shall be in writing and signed by MLBFS. Any waiver of any provision of this Loan Agreement or any of the Additional Agreements and any consent to any departure by Customer from the terms of this Loan Agreement or any of the Additional Agreements shall be effective only in the specific instance and for the specific purpose for which given. Except as otherwise expressly provided herein, no notice to or demand on Customer shall in any case entitle Customer to any other or further notice or demand in similar or other circumstances. -8- 9 (b) Disclosure. Customer hereby irrevocably authorizes MLBFS and each of its affiliates, including without limitation MLBF&S, to at any time (whether or not an Event of Default shall have occurred) obtain from and disclose to each other any and all financial and other information about Customer. In connection with said authorization, the parties recognize that in order to provide a WCMA Line of Credit certain information about Customer is required to be made available on a computer network accessible by certain affiliates of MLBFS, including MLPF&S. Notwithstanding the foregoing, MLBFS will use reasonable precautions to maintain on a confidential basis the contents of any accounts receivable agings or other information expressly in writing designated by Customer as being "confidential" and safeguard such information against unauthorized publication or disclosure to third parties other than to MLBFS employees, agents, auditors and consultants who have a need to know in connection with this Loan Agreement and/or in the ordinary course of MLBFS' business. Nothing herein shall be deemed to preclude MLBFS from disclosing any such information: (i) to those parties to whom MLBFS is, in the opinion of its counsel, required to disclose such information by any law, judicial order or rule, or by any order, rule, regulation or request of any governmental, regulatory or self-regulatory body, or (ii) to anyone if and to the extent that such information becomes lawfully available from any other source. (c) Communications. All notices and other communications required or permitted hereunder shall be in writing, and shall be either delivered personally, mailed by postage prepaid certified mail or sent by express overnight courier or by facsimile. Such notices and communications shall be deemed to be given on the date of personal delivery, facsimile transmission or actual delivery of certified mail, or one Business Day after delivery to an express overnight courier. Unless otherwise specified in a notice sent or delivered in accordance with the terms hereof, notices and other communications in writing shall be given to the parties hereto at their respective addresses set forth at the beginning of this Loan Agreement, or, in the case of facsimile transmission, to the parties at their respective regular facsimile telephone number. (d) Costs, Expenses and Taxes. Customer shall upon demand pay or reimburse MLBFS for: (i) all Uniform Commercial Code filing and search fees and expenses incurred by MLBFS in connection with the verification, perfection or preservation of MLBFS' rights hereunder or in any collateral for the Obligations; (ii) any and all stamp, transfer and other taxes and fees payable or determined to be payable in connection with the execution, delivery and/or recording of this Loan Agreement or any of the Additional Agreements; and (iii) all reasonable fees and out-of-pocket expenses (including, but not limited to, reasonable fees and expenses of outside counsel) incurred by MLBFS in connection with the enforcement of this Loan Agreement or any of the Additional Agreements or the protection of MLBFS' rights hereunder or thereunder, excluding, however, salaries and expenses of MLBFS' employees. The obligations of Customer under this paragraph shall survive the expiration or termination of this Loan Agreement and the discharge of the other Obligations. (e) Right to Perform Obligations. If Customer shall fail to do any act or thing which it has covenanted to do under this Loan Agreement or any representation or warranty on the part of Customer contained in this Loan Agreement shall be breached, MLBFS may, in its sole discretion, after 5 days written notice is sent to Customer (or such lesser notice, including no notice, as is reasonable under the circumstances), do the same or cause it to be done or remedy any such breach, and may expend its funds for such purpose. Any and all reasonable amounts so expended by MLBFS shall be repayable to MLBFS by Customer upon demand, with interest at the Interest Rate during the period from and including the date funds are so expended by MLBFS to the date of repayment, and all such amounts shall be additional Obligations. The payment or performance by MLBFS of any of Customer's obligations hereunder shall not relieve Customer of said obligations or of the consequences of having failed to pay or perform the same, and shall not waive or be deemed a cure of any Event of Default. (f) Late Charge. Any payment required to be made by Customer pursuant to this Loan Agreement not paid within 10 days of the applicable due date shall be subject to a late charge in an amount equal to the lesser of: (i) 5% of the overdue amount, or (ii) the maximum amount permitted by applicable law. Such late charge shall be payable on demand, or, without demand, may in the sole discretion of MLBFS be paid by a WCMA Loan and added to the WCMA Loan Balance in the same manner as provided herein for accrued interest. -9- 10 (g) Further Assurances. Customer agrees to do such further acts and things and to execute and deliver to MLBFS such additional agreements, instruments and documents as MLBFS may reasonably require or deem advisable to effectuate the purposes of this Loan Agreement or any the Additional Agreements. (h) Binding Effect. This Loan Agreement and the Additional Agreements shall be binding upon, and shall inure to the benefit of MLBFS, Customer and their respective successors and assigns. Customer shall not assign any of its rights or delegate any of its obligations under this Loan Agreement or any of the Additional Agreements without the prior written consent of MLBFS. Unless otherwise expressly agreed to in a writing signed by MLBFS, no such consent shall in any event relieve Customer of any of its obligations under this Loan Agreement or the Additional Agreements. (i) Headings. Captions and section and paragraph headings in this Loan Agreement are inserted only as a matter of convenience, and shall not affect the interpretation hereof. (j) Governing Law. This Loan Agreement, and, unless otherwise expressly provided therein, each of the Additional Agreements, shall be governed in all respects by the laws of the State of Illinois. (k) Severability of Provisions. Whenever possible, each provision of this Loan Agreement and the Additional Agreements shall be interpreted in such manner as to be effective and valid under applicable law. Any provision of this Loan Agreement or any of the Additional Agreements which is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective only to the extent of such prohibition or unenforceability without invalidating the remaining provisions of this Loan Agreement and the Additional Agreements or affecting the validity or enforceability of such provision in any other jurisdiction. (1) Term. This Loan Agreement shall become effective on the date accepted by MLBFS at its office in Chicago, Illinois, and, subject to the terms hereof, shall continue in effect so long thereafter as the WCMA Line of Credit shall be in effect or there shall be any Obligations outstanding. (m) Counterparts. This Loan Agreement may be executed in one or more counterparts which, when taken together, constitute one and the same agreement. (n) Integration. THIS LOAN AGREEMENT, TOGETHER WITH THE ADDITIONAL AGREEMENTS, CONSTITUTES THE ENTIRE UNDERSTANDING AND REPRESENTS THE FULL AND FINAL AGREEMENT BETWEEN THE PARTIES WITH RESPECT TO THE SUBJECT MATTER HEREOF, AND MAY NOT BE CONTRADICTED BY EVIDENCE OF PRIOR WRITTEN AGREEMENTS OR PRIOR, CONTEMPORANEOUS OR SUBSEQUENT ORAL AGREEMENTS OF THE PARTIES. THERE ARE NO UNWRITTEN ORAL AGREEMENTS OF THE PARTIES. Without limiting the foregoing, Customer acknowledges that: (i) no promise or commitment has been made to it by MLBFS, MLPF&S or any of their respective employees, agents or representatives to extend the availability of the WCMA Line of Credit or the due date of the WCMA Loan Balance beyond the current Maturity Date, or to increase the Maximum WCMA Line of Credit, or otherwise extend any other credit to Customer or any other party; (ii) no purported extension of the Maturity Date, increase in the Maximum WCMA Line of Credit or other extension or agreement to extend credit shall be valid or binding unless expressly set forth in a written instrument signed by MLBFS; and (iii) except as otherwise expressly provided herein, this Loan Agreement supersedes and replaces any and all proposals, letters of intent and approval and commitment letters from MLBFS to Customer, none of which shall be considered an Additional Agreement. No amendment or modification of this Agreement or any of the Additional Agreements to which Customer is a party shall be effective unless in a writing signed by both MLBFS and Customer. (o) Jurisdiction; Waiver. CUSTOMER ACKNOWLEDGES THAT THIS LOAN AGREEMENT IS BEING ACCEPTED BY MLBFS IN PARTIAL CONSIDERATION OF MLBFS' RIGHT AND OPTION, IN ITS SOLE DISCRETION, TO ENFORCE THIS LOAN AGREEMENT AND THE ADDITIONAL AGREEMENTS IN EITHER THE STATE OF ILLINOIS OR IN ANY OTHER JURISDICTION WHERE CUSTOMER OR ANY COLLATERAL FOR THE OBLIGATIONS MAY BE LOCATED. CUSTOMER CONSENTS TO JURISDICTION IN THE STATE OF ILLINOIS AND VENUE IN ANY STATE OR FEDERAL COURT IN -10- 11 THE COUNTY OF COOK FOR SUCH PURPOSES, AND CUSTOMER WAIVES ANY AND ALL RIGHTS TO CONTEST SAID JURISDICTION AND VENUE. CUSTOMER FURTHER WAIVES ANY RIGHTS TO COMMENCE ANY ACTION AGAINST MLBFS IN ANY JURISDICTION EXCEPT IN THE COUNTY OF COOK AND STATE OF ILLINOIS. MLBFS AND CUSTOMER HEREBY EACH EXPRESSLY WAIVE ANY AND ALL RIGHTS TO A TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM BROUGHT BY EITHER OF THE PARTIES AGAINST THE OTHER PARTY WITH RESPECT TO ANY MATTER RELATING TO, ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE WCMA LINE OF CREDIT, THIS LOAN AGREEMENT, ANY ADDITIONAL AGREEMENTS AND/OR ANY OF THE TRANSACTIONS WHICH ARE THE SUBJECT MATTER OF THIS LOAN AGREEMENT. IN WITNESS WHEREOF, this Loan Agreement has been executed as of the day and year first above written. MINIMED INC. By: /s/ [SIG] -------------------------------------------------------------------- Signature (1) Signature (2) /s/ [SIG] - ----------------------------------------------------------------------- Printed Name Printed Name Chief Financial Officer - ----------------------------------------------------------------------- Title Title Accepted at Chicago, Illinois: MERRILL LYNCH BUSINESS FINANCIAL SERVICES INC. By: ------------------------------------------------- -11- 12 [MERRILL LYNCH LOGO] CERTIFICATE OF SECRETARY (WCMA Line Of Credit) THE UNDERSIGNED HEREBY CERTIFIES that the undersigned is the duly appointed and acting Secretary (or Assistant Secretary) of MINIMED INC. , a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware, and that the following is a true, accurate and compared transcript of resolutions duly, validly and lawfully adopted on the 19th day of December, 1996 by the Board of Directors of said corporation acting in accordance with the laws of the state of incorporation and the charter and by-laws of said corporation: "RESOLVED, that it is advisable and in the best interests of this Corporation that in connection with Working Capital Management Account No. 21C-07H08 that this Corporation is subscribing from Merrill Lynch, Pierce, Fenner & Smith Incorporated it obtain from MERRILL LYNCH BUSINESS FINANCIAL SERVICES INC. ("MLBFS") a commercial line of credit referred to by MLBFS as a "WCMA Line of Credit"; and "FURTHER RESOLVED, that the President, any Vice President, Treasurer, Secretary or other officer of this Corporation, or any one or more of them, be and each of them hereby is authorized and empowered for and on behalf of this Corporation to: (a) execute and deliver to MLBFS: (i) a WCMA Note and Loan Agreement and all other agreements, instruments and documents required by MLBFS in connection with said Line of Credit, and (ii) any present or future extensions of and amendments to any of the foregoing; all in such form as such officer shall approve, as conclusively evidenced by his signature thereon; (b) grant to MLBFS such liens and security interests on any of the assets of this Corporation as collateral therefor and/or the other obligations of this Corporation to MLBFS as may be required by MLBFS; and (c) do and perform all such acts and things deemed by any such officer to be necessary or advisable to carry out and perform the undertakings and agreements of this Corporation in connection therewith; and all prior acts of said officers in these premises are hereby ratified and confirmed; and "FURTHER RESOLVED, that MLBFS is authorized to rely upon the foregoing resolutions until it receives written notice of any change or revocation, which change or revocation shall not in any event affect the obligations of this Corporation with respect to any transaction committed to by MLBFS or having its inception prior to the receipt of such notice by MLBFS." THE UNDERSIGNED FURTHER CERTIFIES that the foregoing resolutions have not been rescinded, modified or repealed in any manner and are in full force and effect as of the date of this Certificate, and that the following individuals are now the elected and acting officers of said corporation: President: /s/ [SIG] ------------------------------ Vice President: /s/ [SIG] ------------------------------ Secretary: /s/ [SIG] ------------------------------ IN WITNESS WHEREOF, the undersigned has executed this Certificate and has affixed the seal of said corporation hereto, pursuant to due authorization, all as of this 21st day of January, 1997. (Corporate Seal) /s/ [SIG] ------------------------------- Secretary ERIC KENTOR ------------------------------- Printed Name 13 THIS SPACE FOR USE OF FILING OFFICER FINANCING STATEMENT - FOLLOW INSTRUCTIONS CAREFULLY This Financing Statement is presented for filing pursuant to the Uniform Commercial Code and will remain effective, with certain exceptions, for 5 years from date of filing. - --------------------------------------------------------------------------------------------------------------------- A. NAME & TEL. OF CONTACT AT FILER (optional) B. FILING OFFICE ACCT. # (optional) - --------------------------------------------------------------------------------------------------------------------- C. RETURN COPY TO: (Name and Mailing Address) CSC NETWORKS/PHL&FS 1013 Centre Rd. Wilmington, DE 18905-1297 - --------------------------------------------------------------------------------------------------------------------- D. OPTIONAL DESIGNATION (if applicable): [ ] LESSOR/LESSEE [ ] [ ] CONSIGNOR/CONSIGNEE [ ] NON-UCC FILING 1. DEBTOR'S EXACT FULL LEGAL NAME - insert only one debtor name (1a or 1b) 1a. ENTITY'S NAME Minimed Inc. OR ----------------------------------------------------------------------------------------------------------------- 1b. INDIVIDUAL'S LAST NAME FIRST NAME MIDDLE NAME SUFFIX ----------------------------------------------------------------------------------------------------------------- 1c. MAILING ADDRESS CITY STATE COUNTRY POSTAGE CODE 12744 San Fernando Road Sylmar CA 91342 ----------------------------------------------------------------------------------------------------------------- 1d. SS OR TAX I.D.# OPTIONAL 1a. TYPE OF ENTITY 1f. ENTITY'S STATE 1g. ENTITIES ORGANIZATIONAL ADD'NL INFO RE OR COUNTRY OF I.D. # IF ANY ENTITY DEBTOR ORGANIZATION [ ] None ----------------------------------------------------------------------------------------------------------------- 2. ADDITIONAL DEBTOR'S EXACT FULL LEGAL NAME - Insert only one debtor name (2a or 2b) 2a. ENTITY'S NAME OR ----------------------------------------------------------------------------------------------------------------- 2b. INDIVIDUAL'S LAST NAME FIRST NAME MIDDLE NAME SUFFIX ----------------------------------------------------------------------------------------------------------------- 2c. MAILING ADDRESS CITY STATE COUNTRY POSTAGE CODE ----------------------------------------------------------------------------------------------------------------- 2d. SS OR TAX I.D.# OPTIONAL 1a. TYPE OF ENTITY 2f. ENTITY'S STATE 2g. ENTITIES ORGANIZATIONAL ADD'NL INFO RE OR COUNTRY OF I.D. # IF ANY ENTITY DEBTOR ORGANIZATION [ ] None ----------------------------------------------------------------------------------------------------------------- 3. SECURED PARTY'S (ORIGINAL S/P or ITS TOTAL ASSIGNEE) EXACT FULL LEGAL NAME - insert only one secured party name (3a or 3b) 3a. ENTITY'S NAME Merrill Lynch Business Financial Services Inc. OR ----------------------------------------------------------------------------------------------------------------- 3b. INDIVIDUAL'S LAST NAME FIRST NAME MIDDLE NAME SUFFIX ----------------------------------------------------------------------------------------------------------------- 3c. MAILING ADDRESS CITY STATE COUNTRY POSTAGE CODE 33 W. Monroe, 22nd Floor Chicago IL 60603 ----------------------------------------------------------------------------------------------------------------- 4. THIS FINANCING STATEMENT covers the following types or items of property: Debtor has agreed that, except upon the prior written consent of Secured Party, Debtor will not directly or indirectly mortgage, encumber or grant a security interest in any of its property, now owned or hereafter acquired except (i) liens for current taxes not delinquent or being contested in good faith by appropriate proceedings, (ii) other non-consensual liens arising in the ordinary course of business for sums not due, (iii) purchase money liens upon and leases of equipment, and (iv) liens in favor of MLBFS. THIS FILING IS GIVEN AS NOTICE OF SAID NEGATIVE PLEDGE AGREEMENT, AND IS NOT INTENDED TO CREATE OR PERFECT A SECURITY INTEREST. CSC#/M000023/96-000787/1/1 CA:California SOS - ----------------------------------------------------------------------------------------------------------------------------- CHECK [ ] This FINANCING STATEMENT is signed by the Secured Party instead of 7. if filed in Florida (check one) the Debtor to perfect a security interest (a) in collateral already subject to a security interest in another jurisdiction when it was [ ] Documentary [ ] Documentary stamp brought into this state, or when the debtor's location was changed stamp tax paid tax not applicable to this state, or (b) in accordance with other statutory provisions (additional date may be required) (If applicable) - ------------------------------------------------------------------------------------------------------------------------------ 6. REQUIRED SIGNATURE(S) 8. [ ] This FINANCING STATEMENT is to be filed (for record) Minimed Inc. (or recorded) in the REAL ESTATE RECORDS Attach Addendum (if applicable) /s/ [ILLEGIBLE] 1/21/92 - ------------------------------------------------------------------------------------------------------------------------------ Merrill Lynch Business Financial Services Inc. 9. Check to REQUEST SEARCH CERTIFICATE(S) on Debtor(s) (ADDITIONAL FEE) (optional) [ ] All Debtors [ ] Debtor 1 [ ] Debtor 2 - ------------------------------------------------------------------------------------------------------------------------------ (1) FILING OFFICER COPY - NATIONAL FINANCING STATEMENT (FORM UCC 1) (TRANS) (REV. 12/18/95)
EX-10.17 4 LEASE DATED AS OF AUGUST 1, 1995 1 EXHIBIT 10.17 STANDARD INDUSTRIAL/COMMERCIAL MULTI-TENANT LEASE--MODIFIED NET AMERICAN INDUSTRIAL REAL ESTATE ASSOCIATION [LOGO] 1. BASIC PROVISIONS ("BASIC PROVISIONS"). 1.1 PARTIES: This Lease ("LEASE"), dated for reference purposes only, ________________________________, 19 ______, is made by and between MiniMed Inc., a Delaware Corporation ("LESSOR") and Alfred E. Mann ("LESSEE"), (collectively the "PARTIES," or individually a "PARTY"). 1.2(a) PREMISES: That certain portion of the Building, including all improvements therein or to be provided by Lessor under the terms of this Lease, commonly known by the street address of 12744 San Fernando Road, located in the City of Sylmar, County of Los Angeles, State of California, with zip code 91342, as outlined on Exhibit A attached hereto ("PREMISES"). The "BUILDING" is that certain building containing the Premises and generally described as (describe briefly the nature of the Building): NAMF Building 3. In addition to Lessee's rights to use and occupy the Premises as hereinafter specified, Lessee shall have non-exclusive rights to the Common Areas (as defined in Paragraph 2.7 below) as hereinafter specified, but shall not have any rights to the roof, exterior walls or utility raceways of the Building or to any other buildings in the Industrial Center. The Premises, the Building, the Common Areas, the land upon which they are located, along with all other buildings and improvements thereon, are herein collectively referred to as the "INDUSTRIAL CENTER." (Also see Paragraph 2.) 1.2(b) PARKING: 20 unreserved vehicle parking spaces ("UNRESERVED PARKING SPACES"); and 3 reserved vehicle parking spaces ("RESERVED PARKING SPACES"). (Also see Paragraph 2.6.) 1.3 TERM: 2 years and 5 months ("ORIGINAL TERM") commencing as of August 1, 1995 ("COMMENCEMENT DATE") and ending December 31, 1997 ("EXPIRATION DATE"). (Also see Paragraph 3.) 1.4 EARLY POSSESSION: _________________________ ("EARLY POSSESSION DATE"). (Also see Paragraphs 3.2 and 3.3.) 1.5 BASE RENT: $3,120.00 per month ("BASE RENT"), payable on the 1st day of each month commencing August 1, 1995 (Also see Paragraph 4.) [ ] If this box is checked, this Lease provides for the Base Rent to be adjusted per Addendum ________, attached hereto. 1.6(a) BASE RENT PAID UPON EXECUTION: $12,480 as Base Rent for the period August 1, 1995 to November 30, 1995. 1.6(b) LESSEE'S SHARE OF COMMON AREA OPERATING EXPENSES: Seven percent (7%) ("LESSEE'S SHARE") as determined by [x] prorata square footage of the Premises as compared to the total square footage of the Building or [ ] other criteria as described in Addendum _____. 1.7 SECURITY DEPOSIT: $ - 0 - ("SECURITY DEPOSIT"). (Also see Paragraph 5.) 1.8 PERMITTED USE: Operation of a medical research foundation and related activities. ("PERMITTED USE") (Also see Paragraph 6.) 1.12 ADDENDA AND EXHIBITS. Attached hereto is an Addendum or Addenda consisting of Paragraphs __________ through __________, and Exhibits __________ through __________, all of which constitute a part of this Lease. 2. PREMISES, PARKING AND COMMON AREAS. 2.1 LETTING. Lessor hereby leases to Lessee, and Lessee hereby leases from Lessor, the Premises, for the term, at the rental, and upon all of the terms, covenants and conditions set forth in this Lease. Unless otherwise provided herein, any statement of square footage set forth in this Lease, or that may have been used in calculating rental and/or Common Area Operating Expenses, is an approximation which Lessor and Lessee agree is reasonable and the rental and Lessee's Share (as defined in Paragraph 1.6(b)) based thereon is not subject to revision whether or not the actual square footage is more or less. 2.2 CONDITION. Lessor shall deliver the Premises to Lessee clean and free of debris on the Commencement Date and warrants to Lessee that the existing plumbing, electrical systems, fire sprinkler system, lighting, air conditioning and heating systems and loading doors, if any, in the Premises, other than those constructed by Lessee, shall be in good operating condition on the Commencement Date. If a non-compliance with said warranty exists as of the Commencement Date, Lessor shall, except as otherwise provided in this Lease, promptly after receipt of written notice from Lessee setting forth with specificity the nature and extent of such non-compliance, rectify same at Lessor's expense. If Lessee does not give Lessor written notice of a non-compliance with this warranty within thirty (30) days after the Commencement Date, correction of that non-compliance shall be the obligation of Lessee at Lessee's sole cost and expense. 2.3 COMPLIANCE WITH COVENANTS, RESTRICTIONS AND BUILDING CODE. Lessor warrants that any improvements (other than those constructed by Lessee or at Lessee's direction) on or in the Premises which have been constructed or installed by Lessor or with Lessor's consent or at Lessor's direction shall comply with all applicable covenants or restrictions of record and applicable building codes, regulations and ordinances in effect on the Commencement Date. Lessor further warrants to Lessee that Lessor has no knowledge of any claim having been made by any governmental agency that a violation or violations of applicable building codes, regulations, or ordinances exist with regard to the Premises as of the Commencement Date. Said warranties shall not apply to any Alterations or Utility Installations (defined in Paragraph 7.3(a)) made or to be made by Lessee. If the Premises do not comply with said warranties, Lessor shall, except as otherwise provided in this Lease, promptly after receipt of written notice from Lessee given within six (6) months following the Commencement Date and setting forth with specificity the nature and extent of such non-compliance, take such action, at Lessor's expense, as may be reasonable or appropriate to rectify the non-compliance. Lessor makes no warranty that the Permitted Use in Paragraph 1.8 is permitted for the Premises under Applicable Laws (as defined in Paragraph 2.4). 2.4 ACCEPTANCE OF PREMISES. Lessee hereby acknowledges: (a) that he has satisfied himself with respect to the condition of the Premises (including but not limited to the electrical and fire sprinkler systems, security, environmental aspects, seismic and earthquake requirements, and compliance with the Americans with Disabilities Act and applicable zoning, municipal, county, state and federal laws, ordinances and regulations and any covenants or restrictions of record (collectively, "APPLICABLE LAWS") and the present and future suitability of the Premises for Lessee's intended use; (b) that Lessee has made such investigation as it deems necessary with reference to such matters, is satisfied with reference thereto, and assumes all responsibility therefore as the same relate to Lessee's occupancy of the Premises and/or the terms of this Lease; and (c) that neither Lessor, nor any of Lessor's agents, has made any oral or written representations or warranties with respect to said matters other than as set forth in this Lease. 2.5 LESSEE AS PRIOR OWNER/OCCUPANT. The warranties made by Lessor in this Paragraph 2 shall be of no force or effect if immediately prior to the date set forth in Paragraph 1.1 Lessee was the owner or occupant of the Premises. In such event, Lessee shall, at Lessee's sole cost and expense, correct any non-compliance of the Premises with said warranties. INITIALS: _____________ MULTI-TENANT - MODIFIED NET _____________ (C)American Industrial Real Estate Association 1993 2 2.6 VEHICLE PARKING. Lessee shall be entitled to use the number of Unreserved Parking Spaces and Reserved Parking Spaces specified in Paragraph 1.2(b) on those portions of the Common Areas designated from time to time by Lessor for parking. Lessee shall not use more parking spaces than said number. Said parking spaces shall be used for parking by vehicles no larger than full-size passenger automobiles or pick-up trucks, herein called "PERMITTED SIZE VEHICLES." Vehicles other than Permitted Size Vehicles shall be parked and loaded or unloaded as directed by Lessor in the Rules and Regulations (as defined in Paragraph 40) issued by Lessor. (Also see Paragraph 2.9.) (a) Lessee shall not permit or allow any vehicles that belong to or are controlled by Lessee or Lessee's employees, suppliers, shippers, customers, contractors or invitees to be loaded, unloaded, or parked in areas other than those designated by Lessor for such activities. (b) If Lessee permits or allows any of the prohibited activities described in this Paragraph 2.6, then Lessor shall have the right, without notice, in addition to such other rights and remedies that it may have, to remove or tow away the vehicle involved and charge the cost to Lessee, which cost shall be immediately payable upon demand by Lessor. (c) Lessor shall at the Commencement Date of this Lease, provide the parking facilities required by Applicable Law. 2.7 COMMON AREAS - DEFINITION. The term "COMMON AREAS" is defined as all areas and facilities outside the Premises and within the exterior boundary line of the Industrial Center and interior utility raceways within the Premises that are provided and designated by the Lessor from time to time for the general non-exclusive use of Lessor, Lessee and other lessees of the Industrial Center and their respective employees, suppliers, shippers, customers, contractors and invitees, including parking areas, loading and unloading areas, trash areas, roadways, sidewalks, walkways, parkways, driveways and landscaped areas. 2.8 COMMON AREAS - LESSEE'S RIGHTS. Lessor hereby grants to Lessee, for the benefit of Lessee and its employees, suppliers, shippers, contractors, customers and invitees, during the term of this Lease, the non-exclusive right to use, in common with others entitled to such use, the Common Areas as they exist from time to time, subject to any rights, powers, and privileges reserved by Lessor under the terms hereof or under the terms of any rules and regulations or restrictions governing the use of the Industrial Center. Under no circumstances shall the right herein granted to use the Common Areas be deemed to include the right to store any property, temporarily or permanently, in the Common Areas. Any such storage shall be permitted only by the prior written consent of Lessor or Lessor's designated agent, which consent may be revoked at any time. In the event that any unauthorized storage shall occur then Lessor shall have the right, without notice, in addition to such other rights and remedies that it may have, to remove the property and charge the cost to Lessee, which cost shall be immediately payable upon demand by Lessor. 2.9 COMMON AREAS - RULES AND REGULATIONS. Lessor or such other person(s) as Lessor may appoint shall have the exclusive control and management of the Common Areas and shall have the right, from time to time, to establish, modify, amend and enforce reasonable Rules and Regulations with respect thereto in accordance with Paragraph 40. Lessee agrees to abide by and conform to all such Rules and Regulations, and to cause its employees, suppliers, shippers, customers, contractors and invitees to so abide and conform. Lessor shall not be responsible to Lessee for the non-compliance with said rules and regulations by other lessees of the Industrial Center. 2.10 COMMON AREAS - CHANGES. Lessor shall have the right, in Lessor's sole discretion, from time to time: (a) To make changes to the Common Areas, including, without limitation, changes in the location, size, shape and number of driveways, entrances, parking spaces, parking areas, loading and unloading areas, ingress, egress, direction of traffic, landscaped areas, walkways and utility raceways; (b) To close temporarily any of the Common Areas for maintenance purposes so long as reasonable access to the Premises remains available; (c) To designate other land outside the boundaries of the Industrial Center to be a part of the Common Areas; (d) To add additional buildings and improvements to the Common Areas; (e) To use the Common Areas while engaged in making additional improvements, repairs or alterations to the Industrial Center, or any portion thereof; and (f) To do and perform such other acts and make such other changes in, to or with respect to the Common Areas and Industrial Center as Lessor may, in the exercise of sound business judgment, deem to be appropriate. 3. TERM. 3.1 TERM. The Commencement Date, Expiration Date and Original Term of this Lease are as specified in Paragraph 1.3. 3.2 EARLY POSSESSION. If an Early Possession Date is specified in Paragraph 1.4 and if Lessee totally or partially occupies the Premises after the Early Possession Date but prior to the Commencement Date, the obligation to pay Base Rent shall be abated for the period of such early occupancy. All other terms of this Lease, however, (including but not limited to the obligations to pay Lessee's Share of Common Area Operating Expenses and to carry the insurance required by Paragraph 8) shall be in effect during such period. Any such early possession shall not affect nor advance the Expiration Date of the Original Term. 3.3 DELAY IN POSSESSION. If for any reason Lessor cannot deliver possession of the Premises to Lessee by the Early Possession Date, if one is specified in Paragraph 1.4, or if no Early Possession Date is specified, by the Commencement Date, Lessor shall not be subject to any liability therefor, nor shall such failure affect the validity of this Lease, or the obligations of Lessee hereunder, or extend the term hereof, but in such case, Lessee shall not, except as otherwise provided herein, be obligated to pay rent or perform any other obligation of Lessee under the terms of this Lease until Lessor delivers possession of the Premises to Lessee. If possession of the Premises is not delivered to Lessee within sixty (60) days after the Commencement Date, Lessee may, at its option, by notice in writing to Lessor within ten (10) days after the end of said sixty (60) day period, cancel this Lease, in which event the parties shall be discharged from all obligations hereunder; provided further, however, that if such written notice of Lessee is not received by Lessor within said ten (10) day period, Lessee's right to cancel this Lease hereunder shall terminate and be of no further force or effect. Except as may be otherwise provided, and regardless of when the Original Term actually commences, if possession is not tendered to Lessee when required by this Lease and Lessee does not terminate this Lease, as aforesaid, the period free of the obligation to pay Base Rent, if any, that Lessee would otherwise have enjoyed shall run from the date of delivery of possession and continue for a period equal to the period during which the Lessee would have otherwise enjoyed under the terms hereof, but minus any days of delay caused by the acts, changes or omissions of Lessee. 4. RENT. 4.1 BASE RENT. Lessee shall pay Base Rent and other rent or charges, as the same may be adjusted from time to time, to Lessor in lawful money of the United States, without offset or deduction, on or before the day on which it is due under the terms of this Lease. Base Rent and all other rent and charges for any period during the term hereof which is for less than one full month shall be prorated based upon the actual number of days of the month involved. Payment of Base Rent and other charges shall be made to Lessor at its address stated herein or to such other persons or at such other addresses as Lessor may from time to time designate in writing to Lessee. 4.2 COMMON AREA OPERATING EXPENSES. Lessee shall pay to Lessor during the term hereof, in addition to the Base Rent, Lessee's Share (as specified in Paragraph 1.6(b)) of all Common Area Operating Expenses, as hereinafter defined, during each calendar year of the term of this Lease, in accordance with the following provisions: (a) "COMMON AREA OPERATING EXPENSES" are defined, for purposes of this Lease, as all costs incurred by Lessor relating to the ownership and operation of the Industrial Center, including, but not limited to, the following: (i) The operation, repair and maintenance, in neat, clean, good order and condition, of the following: (aa) The Common Areas, including parking areas, loading and unloading areas, trash areas, roadways, sidewalks, walkways, parkways, driveways, landscaped areas, striping, bumpers, irrigation systems, Common Area lighting facilities, fences and gates, elevators and roof. (bb) Exterior signs and any tenant directories. (cc) Fire detection and sprinkler systems. (ii) The cost of water, gas, electricity and telephone to service the Common Areas. (iii) Trash disposal, property management and security services and the costs of any environmental inspections. (iv) Reserves set aside for maintenance and repair of Common Areas. (v) Real Property Taxes (as defined in Paragraph 10.2) to be paid by Lessor for the Building and the Common Areas under Paragraph 10 hereof. (vi) The cost of the premiums for the insurance policies maintained by Lessor under Paragraph 8 hereof. (vii) Any deductible portion of an insured loss concerning the Building or the Common Areas. (viii) Any other services to be provided by Lessor that are stated elsewhere in this Lease to be a Common Area Operating Expense. (b) Any Common Area Operating Expenses and Real Property Taxes that are specifically attributable to the Building or to any other building in the Industrial Center or to the operation, repair and maintenance thereof, shall be allocated entirely to the Building or to such other building. However, any Common Area Operating Expenses and Real Property Taxes that are not specifically attributable to the Building or to any other building or to the operation, repair and maintenance thereof, shall be equitably allocated by Lessor to all buildings in the Industrial Center. (c) The inclusion of the improvements, facilities and services set forth in Subparagraph 4.2(a) shall not be deemed to impose an obligation upon Lessor to either have said improvements or facilities or to provide those services unless the Industrial Center already has the same, Lessor already provides the services, or Lessor has agreed elsewhere in this Lease to provide the same or some of them. (d) Lessee's Share of Common Area Operating Expenses shall be payable by Lessee within ten (10) days after a reasonably detailed statement of actual expenses is presented to Lessee by Lessor. At Lessor's option, however, an amount may be estimated by Lessor from time to time of Lessee's Share of annual Common Area Operating Expenses and the same shall be payable monthly or quarterly, as Lessor shall designate, during each 12-month period of the Lease term, on the same day as the Base Rent is due hereunder. Lessor shall deliver to Lessee within sixty (60) days after the expiration of each calendar year a reasonably detailed statement showing Lessee's Share of the actual Common Area Operating Expenses incurred during the preceding year. If Lessee's payments under this Paragraph 4.2(d) during said preceding year exceed Lessee's Share as indicated on said statement, Lessee shall be credited the amount of such over- MULTI-TENANT-MODIFIED NET Initials:____ (C) American Industrial Real Estate ____ Association 1993 -2- 3 payment against Lessee's Share of Common Area Operating Expenses next becoming due. If Lessee's payments under this Paragraph 4.2(d) during said preceding year were less than Lessee's Share as indicated on said statement, Lessee shall pay to Lessor the amount of the deficiency within ten (1O) days after delivery by Lessor to Lessee of said statement. 5. SECURITY DEPOSIT. Lessee shall deposit with Lessor upon Lessee's execution hereof the Security Deposit set forth in Paragraph 1.7 as security for Lessee's faithful performance of Lessee's obligations under this Lease. If Lessee fails to pay Base Rent or other rent or charges due hereunder, or otherwise Defaults under this Lease (as defined in Paragraph 13.1), Lessor may use, apply or retain all or any portion of said Security Deposit for the payment of any amount due Lessor or to reimburse or compensate Lessor for any liability, cost, expense, loss or damage (including attorneys' fees) which Lessor may suffer or incur by reason thereof. If Lessor uses or applies all or any portion of said Security Deposit, Lessee shall within ten (10) days after written request therefore deposit monies with Lessor sufficient to restore said Security Deposit to the full amount required by this Lease. Any time the Base Rent increases during the term of this Lease, Lessee shall, upon written request from Lessor, deposit additional monies with Lessor as an addition to the Security Deposit so that the total amount of the Security Deposit shall at all times bear the same proportion to the then current Base Rent as the initial Security Deposit bears to the initial Base Rent set forth in Paragraph 1.5. Lessor shall not be required to keep all or any part of the Security Deposit separate from its general accounts. Lessor shall, at the expiration or earlier termination of the term hereof and after Lessee has vacated the Premises, return to Lessee (or, at Lessor's option, to the last assignee, if any, of Lessee's interest herein), that portion of the Security Deposit not used or applied by Lessor. Unless otherwise expressly agreed in writing by Lessor, no part of the Security Deposit shall be considered to be held in trust, to bear interest or other increment for its use, or to be prepayment for any monies to be paid by Lessee under this Lease. 6. USE 6.1 PERMITTED USE. (a) Lessee shall use and occupy the Premises only for the Permitted Use set forth in Paragraph 1.8, or any other legal use which is reasonably comparable thereto, and for no other purpose. Lessee shall not use or permit the use of the Premises in a manner that is unlawful, creates waste or a nuisance, or that disturbs owners and/or occupants of, or causes damage to the Premises or neighboring premises or properties. (b) Lessor hereby agrees to not unreasonably withhold or delay its consent to any written request by Lessee, Lessee's assignees or subtenants, and by prospective assignees and subtenants of Lessee, its assignees and subtenants, for a modification of said Permitted Use, so long as the same will not impair the structural integrity of the improvements on the Premises or in the Building or the mechanical or electrical systems therein, does not conflict with uses by other lessees, is not significantly more burdensome to the Premises or the Building and the improvements thereon, and is otherwise permissible pursuant to this Paragraph 6. If Lessor elects to withhold such consent, Lessor shall within five (5) business days after such request give a written notification of same, which notice shall include an explanation of Lessor's reasonable objections to the change in use. 6.2 HAZARDOUS SUBSTANCES. (a) REPORTABLE USES REQUIRE CONSENT. The term "HAZARDOUS SUBSTANCE" as used in this Lease shall mean any product, substance, chemical, material or waste whose presence, nature, quantity and/or intensity of existence, use, manufacture, disposal, transportation, spill, release or effect, either by itself or in combination with other materials expected to be on the Premises, is either: (i) potentially injurious to the public health, safety or welfare, the environment, or the Premises; (ii) regulated or monitored by any governmental authority; or (iii) a basis for potential liability of Lessor to any governmental agency or third party under any applicable statute or common law theory. Hazardous Substance shall include, but not be limited to, hydrocarbons, petroleum, gasoline, crude oil or any products or by-products thereof. Lessee shall not engage in any activity in or about the Premises which constitutes a Reportable Use (as hereinafter defined) of Hazardous Substances without the express prior written consent of Lessor and compliance in a timely manner (at Lessee's sole cost and expense) with all Applicable Requirements (as defined in Paragraph 6.3). "REPORTABLE USE" shall mean (i) the installation or use of any above or below ground storage tank, (ii) the generation, possession, storage, use, transportation, or disposal of a Hazardous Substance that requires a permit from, or with respect to which a report, notice, registration or business plan is required to be filed with, any governmental authority, and (iii) the presence in, on or about the Premises of a Hazardous Substance with respect to which any Applicable Laws require that a notice be given to persons entering or occupying the Premises or neighboring properties. Notwithstanding the foregoing, Lessee may, without Lessor's prior consent, but upon notice to Lessor and in compliance with all Applicable Requirements, use any ordinary and customary materials reasonably required to be used by Lessee in the normal course of the Permitted Use, so long as such use is not a Reportable Use and does not expose the Premises or neighboring properties to any meaningful risk of contamination or damage or expose Lessor to any liability therefor. In addition, Lessor may (but without any obligation to do so) condition its consent to any Reportable Use of any Hazardous Substance by Lessee upon Lessee's giving Lessor such additional assurances as Lessor, in its reasonable discretion, deems necessary to protect itself, the public, the Premises and the environment against damage, contamination or injury and/or liability therefor, including but not limited to the installation (and, at Lessor's option, removal on or before Lease expiration or earlier termination) of reasonably necessary protective modifications to the Premises (such as concrete encasements) and/or the deposit of an additional Security Deposit under Paragraph 5 hereof. (b) DUTY TO INFORM LESSOR. If Lessee knows, or has reasonable cause to believe, that a Hazardous Substance has come to be located in, on, under or about the Premises or the Building, other than as previously consented to by Lessor, Lessee shall immediately give Lessor written notice thereof, together with a copy of any statement, report, notice, registration, application, permit, business plan, license, claim, action, or proceeding given to, or received from, any governmental authority or private party concerning the presence, spill, release, discharge of, or exposure to, such Hazardous Substance including but not limited to all such documents as may be involved in any Reportable Use involving the Premises. Lessee shall not cause or permit any Hazardous Substance to be spilled or released in, on, under or about the Premises (including, without limitation, through the plumbing or sanitary sewer system). (c) INDEMNIFICATION. Lessee shall indemnify, protect, defend and hold Lessor, its agents, employees, lenders and ground lessor, if any, and the Premises, harmless from and against any and all damages, liabilities, judgments, costs, claims, liens, expenses, penalties, loss of permits and attorneys' and consultants' fees arising out of or involving any Hazardous Substance brought onto the Premises by or for Lessee or by anyone under Lessee's control. Lessee's obligations under this Paragraph 6.2(c) shall include, but not be limited to, the effects of any contamination or injury to person, property or the environment created or suffered by Lessee, and the cost of investigation (including consultants' and attorneys' fees and testing), removal, remediation, restoration and/or abatement thereof, or of any contamination therein involved, and shall survive the expiration or earlier termination of this Lease. No termination, cancellation or release agreement entered into by Lessor and Lessee shall release Lessee from its obligations under this Lease with respect to Hazardous Substances, unless specifically so agreed by Lessor in writing at the time of such agreement. 6.3 LESSEE'S COMPLIANCE WITH REQUIREMENTS. Lessee shall, at Lessee's sole cost and expense, fully, diligently and in a timely manner, comply with all "APPLICABLE REQUIREMENTS," which term is used in this Lease to mean all laws, rules, regulations, ordinances, directives, covenants, easements and restrictions of record, permits, the requirements of any applicable fire insurance underwriter or rating bureau, and the recommendations of Lessor's engineers and/or consultants, relating in any manner to the Premises (including but not limited to matters pertaining to (i) industrial hygiene, (ii) environmental conditions on, in, under or about the Premises, including soil and groundwater conditions, and (iii) the use, generation, manufacture, production, installation, maintenance, removal, transportation, storage, spill, or release of any Hazardous Substance), now in effect or which may hereafter come into effect. Lessee shall, within five (5) days after receipt of Lessor's written request, provide Lessor with copies of all documents and information, including but not limited to permits, registrations, manifests, applications, reports and certificates, evidencing Lessee's compliance with any Applicable Requirements specified by Lessor, and shall immediately upon receipt, notify Lessor in writing (with copies of any documents involved) of any threatened or actual claim, notice, citation, warning, complaint or report pertaining to or involving failure by Lessee or the Premises to comply with any Applicable Requirements. 6.4 INSPECTION; COMPLIANCE WITH LAW. Lessor, Lessor's agents, employees, contractors and designated representatives, and the holders of any mortgages, deeds of trust or ground leases on the Premises ("LENDERS") shall have the right to enter the Premises at any time in the case of an emergency, and otherwise at reasonable times, for the purpose of inspecting the condition of the Premises and for verifying compliance by Lessee with this Lease and all Applicable Requirements (as defined in Paragraph 6.3), and Lessor shall be entitled to employ experts and/or consultants in connection therewith to advise Lessor with respect to Lessee's activities, including but not limited to Lessee's installation, operation, use, monitoring, maintenance, or removal of any Hazardous Substance on or from the Premises. The costs and expenses of any such inspections shall be paid by the party requesting same, unless a Default or Breach of this Lease by Lessee or a violation of Applicable Requirements or a contamination, caused or materially contributed to by Lessee, is found to exist or to be imminent, or unless the inspection is requested or ordered by a governmental authority as the result of any such existing or imminent violation or contamination. In such case, Lessee shall upon request reimburse Lessor or Lessor's Lender, as the case may be, for the costs and expenses of such inspections. 7. MAINTENANCE, REPAIRS, UTILITY INSTALLATIONS, TRADE FIXTURES AND ALTERATIONS. 7.1 LESSEE'S OBLIGATIONS. (a) Subject to the provisions of Paragraphs 2.2 (Condition), 2.3 (Compliance with Covenants, Restrictions and Building Code), 7.2 (Lessor's Obligations), 9 (Damage or Destruction), and 14 (Condemnation), Lessee shall, at Lessee's sole cost and expense and at all times, keep the Premises and every part thereof in good order, condition and repair (whether or not such portion of the Premises requiring repair, or the means of repairing the same, are reasonably or readily accessible to Lessee, and whether or not the need for such repairs occurs as a result of Lessee's use, any prior use, the elements or the age of such portion of the Premises), including, without limiting the generality of the foregoing, all equipment or facilities specifically serving the Premises, such as plumbing, heating, air conditioning, ventilating, electrical, lighting facilities, boilers, fired or unfired pressure vessels, fire hose connections if within the Premises, fixtures, interior walls, interior surfaces of exterior walls, ceilings, floors, windows, doors, plate glass, and skylights, but excluding any items which are the responsibility of Lessor pursuant to Paragraph 7.2 below. Lessee, in keeping the Premises in good order, condition and repair, shall exercise and perform good maintenance practices. Lessee's obligations shall include restorations, replacements or renewals when necessary to keep the Premises and all improvements thereon or a part thereof in good order, condition and state of repair. (b) Lessee shall, at Lessee's sole cost and expense, procure and maintain a contract, with copies to Lessor, in customary form and substance for and with a contractor specializing and experienced in the inspection, maintenance and service of the heating, air conditioning and ventilation system for the Premises. However, Lessor reserves the right, upon notice to Lessee, to procure and maintain the contract for the heating, air conditioning and ventilating systems, and if Lessor so elects, Lessee shall reimburse Lessor, upon demand, for the cost thereof. (c) If Lessee fails to perform Lessee's obligations under this Paragraph 7.1, Lessor may enter upon the Premises after ten (10) days' prior written notice to Lessee (except in the case of an emergency, in which case no notice shall be required), perform such obligations on Lessee's behalf, and put the Premises in good order, condition and repair, in accordance with Paragraph 13.2 below. 7.2 LESSOR'S OBLIGATIONS. Subject to the provisions of Paragraphs 2.2 (Condition), 2.3 (Compliance with Covenants, Restrictions and Building Code), 4.2 (Common Area Operating Expenses), 6 (Use), 7.1 (Lessee's Obligations), 9 (Damage or Destruction) and 14 (Condemnation), Lessor, subject to reimbursement pursuant to Paragraph 4.2, shall keep in good order, condition and repair the foundations, exterior walls, structural condition of interior bearing walls, exterior roof, fire sprinkler and/or standpipe and hose (if located in the Common Areas) or other automatic fire extinguishing system including fire alarm and/or smoke MULTI-TENANT-MODIFIED NET INITIALS:____ American Industrial Real Estate ____ Association 1993 -3- 4 detection systems and equipment, fire hydrants, parking lots, walkways, parkways, driveways, landscaping, fences, signs and utility systems serving the Common Areas and all part thereof, as well as providing the services for which there is a Common Area Operating Expense pursuant to Paragraph 4.2. Lessor shall not be obligated to paint the exterior or interior surfaces of exterior walls nor shall Lessor be obligated to maintain, repair or replace windows, doors or plate glass of the Premises. Lessee expressly waives the benefit of any statute now or hereafter in effect which would otherwise afford Lessee the right to make repairs at Lessor's expense or to terminate this Lease because of Lessor's failure to keep the Building, Industrial Center or Common Areas in good order, condition and repair. 7.3 UTILITY INSTALLATIONS, TRADE FIXTURES, ALTERATIONS. (a) DEFINITIONS; CONSENT REQUIRED. The term "UTILITY INSTALLATIONS" is used in this Lease to refer to all air lines, power panels, electrical distribution, security, fire protection systems, communications systems, lighting fixtures, heating, ventilating and air conditioning equipment, plumbing, and fencing in, on or about the Premises. The term "TRADE FIXTURES" shall mean Lessee's machinery and equipment which can be removed without doing material damage to the Premises. The term "ALTERATIONS" shall mean any modification of the improvements on the Premises which are provided by Lessor under the terms of this Lease, other than Utility Installations or Trade Fixtures. "LESSEE-OWNED ALTERATIONS AND/OR UTILITY INSTALLATIONS" are defined as Alterations and/or Utility Installations made by Lessee that are not yet owned by Lessor pursuant to Paragraph 7.4(a). Lessee shall not make nor cause to be made any Alterations or Utility Installations in, on, under or about the Premises without Lessor's prior written consent. Lessee may, however, make non-structural Utility Installations to the interior of the Premises (excluding the roof)without Lessor's consent but upon notice to Lessor, so long as they are not visible from the outside of the Premises, do not involve puncturing, relocating or removing the roof or any existing walls, or changing or interfering with the fire sprinkler or fire detection systems and the cumulative cost thereof during the term of this Lease as extended does not exceed $2,500.00. (b) CONSENT. Any Alterations or Utility Installations that Lessee shall desire to make and which require the consent of the Lessor shall be presented to Lessor in written form with detailed plans. All consents given by Lessor, whether by virtue of Paragraph 7.3(a) or by subsequent specific consent, shall be deemed conditioned upon: (i) Lessee's acquiring all applicable permits required by governmental authorities; (ii) the furnishing of copies of such permits together with a copy of the plans and specifications for the Alteration or Utility Installation to Lessor prior to commencement of the work thereon; and (iii) the compliance by Lessee with all conditions of said permits in a prompt and expeditious manner. Any Alterations or Utility Installations by Lessee during the term of this Lease shall be done in a good and workmanlike manner, with good and sufficient materials, and be in compliance with all Applicable Requirements. Lessee shall promptly upon completion thereof furnish Lessor with as-built plans and specifications therefor. Lessor may, (but without obligation to do so) condition its consent to any requested Alteration or Utility Installation that costs $2,500.00 or more upon Lessee's providing Lessor with a lien and completion bond in an amount equal to one and one-half times the estimated cost of such Alteration or Utility Installation. (c) LIEN PROTECTION. Lessee shall pay when due all claims for labor or materials furnished or alleged to have been furnished to or for Lessee at or for use on the Premises, which claims are or may be secured by any mechanic's or materialmen's lien against the Premises or any interest therein. Lessee shall give Lessor not less than ten (10) days' notice prior to the commencement of any work in, on, or about the Premises, and Lessor shall have the right to post notices of non-responsibility in or on the Premises as provided by law. If Lessee shall, in good faith, contest the validity of any such lien, claim or demand, then Lessee shall, at its sole expense, defend and protect itself, Lessor and the Premises against the same and shall pay and satisfy any such adverse judgment that may by rendered thereon before the enforcement thereof against the Lessor or the Premises. If Lessor shall require, Lessee shall furnish to Lessor a surety bond satisfactory to Lessor in an amount equal to one and one-half times the amount of such contested lien claim or demand, indemnifying Lessor against liability for the same, as required by law for the holding of the Premises free from the effect of such lien or claim. In addition, Lessor may require Lessee to pay Lessor's attorneys' fees and costs in participating in such action if Lessor shall decide it is to its best interest to do so. 7.4 OWNERSHIP, REMOVAL, SURRENDER, AND RESTORATION. (a) OWNERSHIP. Subject to Lessor's right to require their removal and to cause Lessee to become the owner thereof as hereinafter provided in the Paragraph 7.4, all Alterations and Utility Installations made to the Premises by Lessee shall be the property of and owned by Lessee, but considered a part of the Premises. Lessor may, at any time and at its option, elect in writing to Lessee to be the owner of all or any specified part of the Lessee-Owned Alterations and Utility Installations. Unless otherwise instructed per Subparagraph 7.4(b) hereof, all Lessee-Owned Alterations and Utility Installations shall, at the expiration or earlier termination of this Lease, become the property of Lessor and remain upon the Premises and be surrendered with the Premises by Lessee. (b) REMOVAL. Unless otherwise agreed in writing, Lessor may require that any or all Lessee-Owned Alterations or Utility Installations be removed by the expiration or earlier termination of this Lease, notwithstanding that their installation may have been consented to by Lessor. Lessor may require the removal at any time of all or any part of any Alterations or Utility Installations made without the required consent of Lessor. (c) SURRENDER/RESTORATION. Lessee shall surrender the Premises by the end of the last day of the Lease term or any earlier termination date, clean and free of debris and in good operating order, condition and state of repair, ordinary wear and tear excepted. Ordinary wear and tear shall not include any damage or deterioration that would have been prevented by good maintenance practice or by Lessee performing all of its obligations under this Lease. Except as otherwise agreed or specified herein, the Premises, as surrendered, shall include the Alterations and Utility Installations The obligation of Lessee shall include the repair of any damage occasioned by the installation, maintenance or removal of Lessee's Trade Fixtures, furnishings, equipment, and Lessee-Owned Alterations and Utility Installations, as well as the removal of any storage tank installed by or for Lessee, and the removal, replacement, or remediation of any soil, material or ground water contaminated by Lessee, all as may then be required by Applicable Requirements and/or good practice. Lessee's Trade Fixtures shall remain the property of Lessee and shall be removed by Lessee subject to its obligation to repair and restore the Premises per this Lease. 8. INSURANCE; INDEMNITY. 8.1 PAYMENT OF PREMIUMS. The cost of the premiums for the insurance policies maintained by Lessor under this Paragraph 8 shall be a Common Area Operating Expense pursuant to Paragraph 4.2 hereof. Premiums for policy periods commencing prior to, or extending beyond, the term of this Lease shall be prorated to coincide with the corresponding Commencement Date or Expiration Date. 8.2 LIABILITY INSURANCE. (a) CARRIED BY LESSEE. Lessee shall obtain and keep in force during the term of this Lease a Commercial General Liability policy of insurance protecting Lessee, Lessor and any Lender(s) whose names have been provided to Lessee in writing (as additional insureds) against claims for bodily injury, personal injury and property damage based upon, involving or arising out of the ownership, use, occupancy or maintenance of the Premises and all areas appurtenant thereto. Such insurance shall be on an occurrence basis providing single limit coverage in an amount not less than $1,000,000 per occurrence with an "Additional Insured-Managers or Lessors of Premises" endorsement and contain the "Amendment of the Pollution Exclusion" endorsement for damage caused by heat, smoke or fumes from a hostile fire. The policy shall not contain any intra-insured exclusions as between insured persons or organizations, but shall include coverage for liability assumed under this Lease as an "INSURED CONTRACT" for the performance of Lessee's indemnity obligations under this Lease. The limits of said insurance required by this Lease or as carried by Lessee shall not, however, limit the liability of Lessee nor relieve Lessee of any obligation hereunder. All insurance to be carried by Lessee shall be primary to and not contributory with any similar insurance carried by Lessor, whose insurance shall be considered excess insurance only. (b) CARRIED BY LESSOR. Lessor shall also maintain liability insurance described in paragraph 8.2(a) above, in addition to and not in lieu of, the insurance required to be maintained by Lessee. Lessee shall not be named as an additional insured therein. 8.3 PROPERTY INSURANCE-BUILDING, IMPROVEMENTS AND RENTAL VALUE (a) BUILDING AND IMPROVEMENTS. Lessor shall obtain and keep in force during the term of this Lease a policy or policies in the name of Lessor, with loss payable to Lessor and to any Lender(s), insuring against loss or damage to the Premises. Such insurance shall be for full replacement cost, as the same shall exist from time to time, or the amount required by any Lender(s), but in no event more than the commercially reasonable and available insurable value thereof if, by reason of the unique nature or age of the improvements involved, such latter amount is less than full replacement cost. Lessee-Owned Alterations and Utility Installations, Trade Fixtures and Lessee's personal property shall be insured by Lessee pursuant to Paragraph 8.4. If the coverage is available and commercially appropriate, Lessor's policy or policies shall insure against all risks of direct physical loss or damage (except the perils of flood and/or earthquake unless required by a Lender), including coverage for any additional costs resulting from debris removal and reasonable amounts of coverage for the enforcement of any ordinance or law regulating the reconstruction or replacement of any undamaged sections of the Building required to be demolished or removed by reason of the enforcement of any building, zoning, safety or land use laws as the result of a covered loss, but not including plate glass insurance. Said policy or policies shall also contain an agreed valuation provision in lieu of any co-insurance clause, waiver of subrogation, and inflation guard protection causing an increase in the annual property insurance coverage amount by a factor of not less than the adjusted U.S. Department of Labor Consumer Price Index for All Urban Consumers for the city nearest to where the Premises are located. (b) RENTAL VALUE. Lessor shall also obtain and keep in force during the term of this Lease a policy or policies in the name of Lessor, with loss payable to Lessor and any Lender(s), insuring the loss of the full rental and other changes payable by all lessees of the Building to Lessor for one year (including all Real Property Taxes, insurance costs, all Common Area Operating Expenses and any scheduled rental increases). Said insurance may provide that in the event the Lease is terminated by reason of an insured loss, the period of indemnity for such coverage shall be extended beyond the date of the completion of repairs or replacement of the Premises, to provide for one full year's loss of rental revenues from the date of any such loss. Said insurance shall contain an agreed valuation provision in lieu of any co-insurance clause, and the amount of coverage shall be adjusted annually to reflect the projected rental income, Real Property Taxes, insurance premium costs and other expenses, if any, otherwise payable, for the next 12-month period. Common Area Operating Expenses shall include any deductible amount in the event of such loss. (c) ADJACENT PREMISES. Lessee shall pay for any increase in the premiums for the property insurance of the Building and for the Common Areas or other buildings in the Industrial Center if said increase is caused by Lessee's acts, omissions, use or occupancy of the Premises. (d) LESSEE'S IMPROVEMENTS. Since Lessor is the Insuring Party, Lessor shall not be required to insure Lessee-Owned Alterations and Utility Installations unless the item in question has become the property of Lessor under the terms of this Lease. 8.4 LESSEE'S PROPERTY INSURANCE. Subject to the requirements of Paragraph 8.5, Lessee at its cost shall either by separate policy or, at Lessor's option, by endorsement to a policy already carried, maintain insurance coverage on all of Lessee's personal property, Trade Fixtures and Lessee-Owned Alterations and Utility Installations in, on, or about the Premises similar in coverage to that carried by Lessor as the Insuring Party under Paragraph 8.3(a). Such insurance shall be full replacement cost coverage with a deductible not to exceed $1,000 per occurrence. The proceeds from any such insurance shall be used by Lessee for the replacement of personal property and the restoration of Trade Fixtures and Lessee-Owned Alterations and Utility Installations. Upon request from Lessor, Lessee shall provide Lessor with written evidence that such insurance is in force. 8.5 INSURANCE POLICIES. Insurance required hereunder shall be in companies duly licensed to transact business in the state where the Premises are located, and maintaining during the policy term a "General Policyholders Rating" of at least B+, V, or such other rating as may be required by a Lender, as set forth in the most current issue of "Best's Insurance Guide." Lessee shall not do or permit to be done anything which shall invalidate the insurance policies referred to in Initials:_________ _________ MULTI-TENANT-MODIFIED NET American Industrial Real Estate Association 1993 - 4 - 5 this Paragraph 8. Lessee shall cause to be delivered to Lessor, within seven (7) days after the earlier of the Early Possession Date or the Commencement Date, certified copies of, or certificates evidencing the existence and amounts of, the insurance required under Paragraph 8.2(a) and 8.4. No such policy shall be cancelable or subject to modification except after thirty (30) days' prior written notice to Lessor. Lessee shall at least thirty (30) days prior to the expiration of such policies, furnish Lessor with evidence of renewals or "insurance binders" evidencing renewal thereof, or Lessor may order such insurance and charge the cost thereof to Lessee, which amount shall be payable by Lessee to Lessor upon demand. 8.6 WAIVER OF SUBROGATION. Without affecting any other rights or remedies, Lessee and Lessor each hereby release and relieve the other, and waive their entire right to recover damages (whether in contract or in tort) against the other, for loss or damage to their property arising out of or incident to the perils required to be insured against under Paragraph 8. The effect of such releases and waivers of the right to recover damages shall not be limited by the amount of insurance carried or required, or by any deductibles applicable thereto. Lessor and Lessee agree to have their respective insurance companies issuing property damage insurance waive any right to subrogation that such companies may have against Lessor or Lessee, as the case may be, so long as the Insurance is not invalidated thereby. 8.7 INDEMNITY. Except for Lessor's negligence and/or breach of express warranties, Lessee shall indemnify, protect, defend and hold harmless the Premises, Lessor and its agents, Lessor's master or ground lessor, partners and Lenders, from and against any and all claims, loss of rents and/or damages, costs, liens, judgments, penalties, loss of permits, attorneys' and consultants' fees, expenses and/or liabilities arising out of, involving, or in connection with, the occupancy of the Premises by Lessee, the conduct of Lessee's business, any act, omission or neglect of Lessee, its agents, contractors, employees or invitees, and out of any Default or Breach by Lessee in the performance in a timely manner of any obligation on Lessee's part to be performed under this Lease. The foregoing shall include, but not be limited to, the defense or pursuit of any claim or any action or proceeding involved therein, and whether or not (in the case of claims made against Lessor) litigated and/or reduced to judgment. In case any action or proceeding be brought against Lessor by reason of any of the foregoing matters, Lessee upon notice from Lessor shall defend the same at Lessee's expense by counsel reasonably satisfactory to Lessor and Lessor shall cooperate with Lessee in such defense. Lessor need not have first paid any such claim in order to be so indemnified. 8.8 EXEMPTION OF LESSOR FROM LIABILITY. Lessor shall not be liable for injury or damage to the person or goods, wares, merchandise or other property of Lessee, Lessee's employees, contractors, invitees, customers, or any other person in or about the Premises, whether such damage or injury is caused by or results from fire, steam, electricity, gas, water or rain, or from the breakage, leakage, obstruction or other defects of pipes, fire sprinklers, wires, appliances, plumbing, air conditioning or lighting fixtures, or from any other cause, whether said injury or damage results from conditions arising upon the Premises or upon other portions of the Building of which the Premises are a part, from other sources or places, and regardless of whether the cause of such damage or injury or the means of repairing the same is accessible or not. Lessor shall not be liable for any damages arising from any act or neglect of any other lessee of Lessor nor from the failure by Lessor to enforce the provisions of any other lease in the Industrial Center. Notwithstanding Lessor's negligence or breach of this Lease, Lessor shall under no circumstances be liable for injury to Lessee's business or for any loss of income or profit therefrom. 9. DAMAGE OR DESTRUCTION. 9.1 DEFINITIONS. (a) "PREMISES PARTIAL DAMAGE" shall mean damage or destruction to the Premises, other than Lessee-Owned Alterations and Utility Installations, the repair cost of which damage or destruction is less than fifty percent (50%) of the then Replacement Cost (as defined in Paragraph 9.1(d)) of the Premises (excluding Lessee-Owned Alterations and Utility Installations and Trade Fixtures) immediately prior to such damage or destruction. (b) "PREMISES TOTAL DESTRUCTION" shall mean damage or destruction to the Premises, other than Lessee-Owned Alterations and Utility Installations, the repair cost of which damage or destruction is fifty percent (50%) or more of the then Replacement Cost of the Premises (excluding Lessee-Owned Alterations and Utility Installations and Trade Fixtures) immediately prior to such damage or destruction. In addition, damage or destruction to the Building, other than Lessee-Owned Alterations and Utility Installations and Trade Fixtures of any lessees of the Building, the cost of which damage or destruction is fifty percent (50%) or more of the then Replacement Cost (excluding Lessee-Owned Alterations and Utility Installations and Trade Fixtures of any lessees of the Building) of the Building shall, at the option of Lessor, be deemed to be Premises Total Destruction. (c) "INSURED LOSS" shall mean damage or destruction to the Premises, other than Lessee-Owned Alterations and Utility Installations and Trade Fixtures, which was caused by an event required to be covered by the insurance described in Paragraph 8.3(a) irrespective of any deductible amounts or coverage limits involved. (d) "REPLACEMENT COST" shall mean the cost to repair or rebuild the improvements owned by Lessor at the time of the occurrence to their condition existing immediately prior thereto, including demolition, debris removal and upgrading required by the operation of applicable building codes, ordinances or laws, and without deduction for depreciation. (e) "HAZARDOUS SUBSTANCE CONDITION" shall mean the occurrence or discovery of a condition involving the presence of, or a contamination by, a Hazardous Substance as defined in Paragraph 6.2(a), in, on, or under the Premises. 9.2 PREMISES PARTIAL DAMAGE - INSURED LOSS. If Premises Partial Damage that is an Insured Loss occurs, then Lessor shall, at Lessor's expense, repair such damage (but not Lessee's Trade Fixtures or Lessee-Owned Alterations and Utility Installations) as soon as reasonably possible and this Lease shall continue in full force and effect. In the event, however, that there is a shortage of insurance proceeds and such shortage is due to the fact that, by reason of the unique nature of the improvements in the Premises, full replacement cost insurance coverage was not commercially reasonable and available, Lessor shall have no obligation to pay for the shortage in insurance proceeds or to fully restore the unique aspects of the Premises unless Lessee provides Lessor with the funds to cover same, or adequate assurance thereof, within ten (10) days following receipt of written notice of such shortage and request therefor. If Lessor receives said funds or adequate assurance thereof within said ten (10) day period, Lessor shall complete them as soon as reasonably possible and this Lease shall remain in full force and effect. If Lessor does not receive such funds or assurance within said period, Lessor may nevertheless elect by written notice to Lessee within ten (10) days thereafter to make such restoration and repair as is commercially reasonable with Lessor paying any shortage in proceeds, in which case this Lease shall remain in full force and effect. If Lessor does not receive such funds or assurance within such ten (10) day period, and if Lessor does not so elect to restore and repair, then this Lease shall terminate sixty (60) days following the occurrence of the damage or destruction. Unless otherwise agreed, Lessee shall in no event have any right to reimbursement from Lessor for any funds contributed by Lessee to repair any such damage or destruction. Premises Partial Damage due to flood or earthquake shall be subject to Paragraph 9.3 rather than Paragraph 9.2, notwithstanding that there may be some insurance coverage, but the net proceeds of any such insurance shall be made available for the repairs if made by either Party. 9.3 PARTIAL DAMAGE - UNINSURED LOSS. If Premises Partial Damage that is not an Insured Loss occurs, unless caused by a negligent or willful act of Lessee (in which event Lessee shall make the repairs at Lessee's expense and this Lease shall continue in full force and effect), Lessor may at Lessor's option, either (i) repair such damage as soon as reasonably possible at Lessor's expense, in which event this Lease shall continue in full force and effect, or (ii) give written notice to Lessee within thirty (30) days after receipt by Lessor of knowledge of the occurrence of such damage of Lessor's desire to terminate this Lease as of the date sixty (60) days following the date of such notice. In the event Lessor elects to give such notice of Lessor's intention to terminate this Lease, Lessee shall have the right within ten (10) days after the receipt of such notice to give written notice to Lessor of Lessee's commitment to pay for the repair of such damage totally at Lessee's expense and without reimbursement from Lessor. Lessee shall provide Lessor with the required funds or satisfactory assurance thereof within thirty (30) days following such commitment from Lessee. In such event this Lease shall continue in full force and effect, and Lessor shall proceed to make such repairs as soon as reasonably possible after the required funds are available. If Lessee does not give such notice and provide the funds or assurance thereof within the times specified above, this Lease shall terminate as of the date specified in Lessor's notice of termination. 9.4 TOTAL DESTRUCTION. Notwithstanding any other provision hereof, if Premises Total Destruction occurs (including any destruction required by any authorized public authority), this Lease shall terminate sixty (60) days following the date of such Premises Total Destruction, whether or not the damage or destruction is an Insured Loss or was caused by a negligent or willful act of Lessee. In the event, however, that the damage or destruction was caused by Lessee, Lessor shall have the right to recover Lessor's damages from Lessee except as released and waived in Paragraph 9.7. 9.5 DAMAGE NEAR END OF TERM. If at any time during the last six (6) months of the term of this Lease there is damage for which the cost to repair exceeds one month's Base Rent, whether or not an Insured Loss, Lessor may, at Lessor's option, terminate this Lease effective sixty (60) days following the date of occurrence of such damage by giving written notice to Lessee of Lessor's election to do so within thirty (30) days after the date of occurrence of such damage. Provided, however, if Lessee at that time has an exercisable option to extend this Lease or to purchase the Premises, then Lessee may preserve this Lease by (a) exercising such option, and (b) providing Lessor with any shortage in insurance proceeds (or adequate assurance thereof) needed to make the repairs on or before the earlier of (i) the date which is ten (10) days after Lessee's receipt of Lessor's written notice purporting to terminate this Lease, or (ii) the day prior to the date upon which such option expires. If Lessee duly exercises such option during such period and provides Lessor with funds (or adequate assurance thereof) to cover any shortage in insurance proceeds, Lessor shall, at Lessor's expense repair such damage as soon as reasonably possible and this Lease shall continue in full force and effect. If Lessee fails to exercise such option and provide such funds or assurance during such period, then this Lease shall terminate as of the date set forth in the first sentence of this Paragraph 9.5. 9.6 ABATEMENT OF RENT; LESSEE'S REMEDIES. (a) In the event of (i) Premises Partial Damage or (ii) Hazardous Substance Condition for which Lessee is not legally responsible, the Base Rent, Common Area Operating Expenses and other charges, if any, payable by Lessee hereunder for the period during which such damage or condition, its repair, remediation or restoration continues, shall be abated in proportion to the degree to which Lessee's use of the Premises is impaired, but not in excess of proceeds from insurance required to be carried under Paragraph 8.3(b). Except for abatement of Base Rent, Common Area Operating Expenses and other charges, if any, as aforesaid, all other obligations of Lessee hereunder shall be performed by Lessee, and Lessee shall have no claim against Lessor for any damage suffered by reason of any such damage, destruction, repair, remediation or restoration. (b) If Lessor shall be obligated to repair or restore the Premises under the provisions of this Paragraph 9 and shall not commence, in a substantial and meaningful way, the repair or restoration of the Premises within ninety (90) days after such obligation shall accrue, Lessee may, at any time prior to the commencement of such repair or restoration, give written notice to Lessor and to any Lenders of which Lessee has actual notice of Lessee's election to terminate this Lease on a date not less than sixty (60) days following the giving of such notice. If Lessee gives such notice to Lessor and such Lenders and such repair or restoration is not commenced within thirty (30) days after receipt of such notice, this Lease shall terminate as of the date specified in said notice. If Lessor or a Lender commences the repair or restoration of the Premises within thirty (30) days after the receipt of such notice, this Lease shall continue in full force and effect "COMMENCE" as used in this Paragraph 9.6 shall mean either the unconditional authorization of the preparation of the required plans, or the beginning of the actual work on the Premises, whichever occurs first. 9.7 HAZARDOUS SUBSTANCE CONDITIONS. If a Hazardous Substance Condition occurs, unless Lessee is legally responsible therefor (in which case Lessee shall make the investigation and remediation thereof required by Applicable Requirements and this Lease shall continue in full force and effect, but subject MULTI-TENANT-MODIFIED NET INITIALS:____ American Industrial Real Estate ____ Association 1993 -5- 6 to Lessor's rights under Paragraph 6.2(c) and Paragraph 13), Lessor may at Lessor's option either (i) investigate and remediate such Hazardous Substance Condition, if required, as soon as reasonably possible at Lessor's expense, in which event this Lease shall continue in full force and effect, or (ii) if the estimated cost to investigate and remediate such condition exceeds twelve (12) times the then monthly Base Rent or $100,000 whichever is greater, give written notice to Lessee within thirty (30) days after receipt by Lessor of knowledge of the occurrence of such Hazardous Substance Condition of Lessor's desire to terminate this Lease as of the date sixty (60) days following the date of such notice. In the event Lessor elects to give such notice of Lessor's intention to terminate this Lease, Lessee shall have the right within ten (10) days after the receipt of such notice to give written notice to Lessor of Lessee's commitment to pay for the excess costs of (a) investigation and remediation of such Hazardous Substance Condition to the extent required by Applicable Requirements, over (b) an amount equal to twelve (12) times the then monthly Base Rent or $100,000, whichever is greater. Lessee shall provide Lessor with the funds required of Lessee or satisfactory assurance thereof within thirty (30) days following said commitment by Lessee. In such event this Lease shall continue in full force and effect, and Lessor shall proceed to make such investigation and remediation as soon as reasonably possible after the required funds are available. If Lessee does not give such notice and provide the required funds or assurance thereof within the time and period specified above, this Lease shall terminate as of the date specified in Lessor's notice of termination. 9.8 TERMINATION - ADVANCE PAYMENTS. Upon termination of this Lease pursuant to this Paragraph 9, Lessor shall return to Lessee any advance payment made by Lessee to Lessor and so much of Lessee's Security Deposit as has not been, or is not then required to be, used by Lessor under the terms of this Lease. 9.9 WAIVER OF STATUTES. Lessor and Lessee agree that the terms of this Lease shall govern the effect of any damage to or destruction of the Premises and the Building with respect to the termination of this Lease and hereby waive the provisions of any present or future statute to the extent it is inconsistent herewith. 10. REAL PROPERTY TAXES. 10.1 PAYMENT OF TAXES. Lessor shall pay the Real Property Taxes, as defined in Paragraph 10.2, applicable to the Industrial Center, and except as otherwise provided in Paragraph 10.3, any such amounts shall be included in the calculation of Common Area Operating Expenses in accordance with the provisions of Paragraph 4.2. 10.2 REAL PROPERTY TAX DEFINITION. As used herein, the term "REAL PROPERTY TAXES" shall include any form of real estate tax or assessment, general, special, ordinary or extraordinary, and any license fee, commercial rental tax, improvement bond or bonds, levy or tax (other than inheritance, personal income or estate taxes) imposed upon the Industrial Center by any authority having the direct or indirect power to tax, including any city, state or federal government, or any school, agricultural, sanitary, fire, street, drainage, or other improvement district thereof, levied against any legal or equitable interest of Lessor in the Industrial Center or any portion thereof, Lessor's right to rent or other income therefrom, and/or Lessor's business of leasing the Premises. The term "REAL PROPERTY TAXES" shall also include any tax, fee, levy, assessment or charge, or any increase therein, imposed by reason of events occurring, or changes in Applicable Law taking effect, during the term of this Lease, including but not limited to a change in the ownership of the Industrial Center or in the improvements thereon, the execution of this Lease, or any modification, amendment or transfer thereof, and whether or not contemplated by the Parties. In calculating Real Property Taxes for any calendar year, the Real Property Taxes for any real estate tax year shall be included in the calculation of Real Property Taxes for such calendar year based upon the number of days which such calendar year and tax year have in common. 10.3 ADDITIONAL IMPROVEMENTS. Common Area Operating Expenses shall not include Real Property Taxes specified in the tax assessor's records and work sheets as being caused by additional improvements placed upon the Industrial Center by other lessees or by Lessor for the exclusive enjoyment of such other lessees. Notwithstanding Paragraph 10.1 hereof, Lessee shall, however, pay to Lessor at the time Common Area Operating Expenses are payable under Paragraph 4.2, the entirety of any increase in Real Property Taxes if assessed solely by reason of Alterations, Trade Fixtures or Utility Installations placed upon the Premises by Lessee or at Lessee's request. 10.4 JOINT ASSESSMENT. If the Building is not separately assessed, Real Property Taxes allocated to the Building shall be an equitable proportion of the Real Property Taxes for all of the land and improvements included within the tax parcel assessed, such proportion to be determined by Lessor from the respective valuations assigned in the assessor's work sheets or such other information as may be reasonably available. Lessor's reasonable determination thereof, in good faith, shall be conclusive. 10.5 LESSEE'S PROPERTY TAXES. Lessee shall pay prior to delinquency all taxes assessed against and levied upon Lessee-Owned Alterations and Utility Installations, Trade Fixtures, furnishings, equipment and all personal property of Lessee contained in the Premises or stored within the Industrial Center. When possible, Lessee shall cause its Lessee-Owned Alterations and Utility Installations, Trade Fixtures, furnishings, equipment and all other personal property to be assessed and billed separately from the real property of Lessor. If any of Lessee's said property shall be assessed with Lessor's real property, Lessee shall pay Lessor the taxes attributable to Lessee's property within ten (10) days after receipt of a written statement setting forth the taxes applicable to Lessee's property. 11. UTILITIES. Lessee shall pay directly for all utilities and services supplied to the Premises, including but not limited to electricity, telephone, gas and cleaning of the Premises, together with any taxes thereon. If any such utilities or services are not separately metered to the Premises or separately billed to the Premises, Lessee shall pay to Lessor a reasonable proportion to be determined by Lessor of all such charges jointly metered or billed with other premises in the Building, in the manner and within the time periods set forth in Paragraph 4.2(d). 12. ASSIGNMENT AND SUBLETTING. 12.1 LESSOR'S CONSENT REQUIRED. (a) Lessee shall not voluntarily or by operation of law assign, transfer, mortgage or otherwise transfer or encumber (collectively, "assign") or sublet all or any part of Lessee's interest in this Lease or in the Premises without Lessor's prior written consent given under and subject to the terms of Paragraph 36. (b) A change in the control of Lessee shall constitute an assignment requiring Lessor's consent. The transfer, on a cumulative basis, of twenty-five percent (25%) or more of the voting control of Lessee shall constitute a change in control for this purpose. (c) The involvement of Lessee or its assets in any transaction, or series of transactions (by way of merger, sale acquisition, financing, refinancing, transfer, leveraged buy-out or otherwise), whether or not a formal assignment or hypothecation of this Lease or Lessee's assets occurs, which results or will result in a reduction of the Net Worth of Lessee, as hereinafter defined, by an amount equal to or greater than twenty-five percent (25%) of such Net Worth of Lessee as it was represented to Lessor at the time of full execution and delivery of this Lease or at the time of the most recent assignment to which Lessor has consented, or as it exists immediately prior to said transaction or transactions constituting such reduction, at whichever time said Net Worth of Lessee was or is greater, shall be considered an assignment of this Lease by Lessee to which Lessor may reasonably withhold its consent. "NET WORTH OF LESSEE" for purposes of this Lease shall be the net worth of Lessee (excluding any Guarantors) established under generally accepted accounting principles consistently applied. (d) An assignment or subletting of Lessee's interest in this Lease without Lessor's specific prior written consent shall, at Lessor's option, be a Default curable after notice per Paragraph 13.1, or a non-curable Breach without the necessity of any notice and grace period. If Lessor elects to treat such unconsented to assignment or subletting as a non-curable Breach, Lessor shall have the right to either: (i) terminate this Lease, or (ii) upon thirty (30) days' written notice ("LESSOR'S NOTICE"), increase the monthly Base Rent for the Premises to the greater of the then fair market rental value of the Premises, as reasonably determined by Lessor, or one hundred ten percent (110%) of the Base Rent then in effect. Pending determination of the new fair market rental value, if disputed by Lessee, Lessee shall pay the amount set forth in Lessor's Notice, with any overpayment credited against the next installment(s) of Base Rent coming due, and any underpayment for the period retroactively to the effective date of the adjustment being due and payable immediately upon the determination thereof. Further, in the event of such Breach and rental adjustment, (i) the purchase price of any option to purchase the Premises held by Lessee shall be subject to similar adjustment to the then fair market value as reasonably determined by Lessor (without the Lease being considered an encumbrance or any deduction for depreciation or obsolescence, and considering the Premises at its highest and best use and in good condition) or one hundred ten percent (110%) of the price previously in effect, (ii) any index-oriented rental or price adjustment formulas contained in this Lease shall be adjusted to require that the base index be determined with reference to the index applicable to the time of such adjustment, and (iii) any fixed rental adjustments scheduled during the remainder of the Lease term shall be increased in the same ratio as the new rental bears to the Base Rent in effect immediately prior to the adjustment specified in Lessor's Notice. (e) Lessee's remedy for any breach of this Paragraph 12.1 by Lessor shall be limited to compensatory damages and/or injunctive relief. 12.2 TERMS AND CONDITIONS APPLICABLE TO ASSIGNMENT AND SUBLETTING. (a) Regardless of Lessor's consent, any assignment or subletting shall not (i) be effective without the express written assumption by such assignee or sublessee of the obligations of Lessee under this Lease, (ii) release Lessee of any obligations hereunder, nor (iii) alter the primary liability of Lessee for the payment of Base Rent and other sums due Lessor hereunder or for the performance of any other obligations to be performed by Lessee under this Lease. (b) Lessor may accept any rent or performance of Lessee's obligations from any person other than Lessee pending approval or disapproval of an assignment. Neither a delay in the approval or disapproval of such assignment nor the acceptance of any rent for performance shall constitute a waiver or estoppel of Lessor's right to exercise its remedies for the Default or Breach by Lessee of any of the terms, covenants or conditions of this Lease. (c) The consent of Lessor to any assignment or subletting shall not constitute a consent to any subsequent assignment or subletting by Lessee or to any subsequent or successive assignment or subletting by the assignee or sublessee. However, Lessor may consent to subsequent sublettings and assignments of the sublease or any amendments or modifications thereto without notifying Lessee or anyone else liable under this Lease or the sublease and without obtaining their consent, and such action shall not relieve such persons from liability under this Lease or sublease. (d) In the event of any Default or Breach of Lessee's obligation under this Lease, Lessor may proceed directly against Lessee, any Guarantors or anyone else responsible for the performance of the Lessee's obligations under this Lease, including any sublessee, without first exhausting Lessor's remedies against any other person or entity responsible therefor to Lessor, or any security held by Lessor. (e) Each request for consent to an assignment or subletting shall be in writing, accompanied by information relevant to Lessor's determination as to the financial and operational responsibility and appropriateness of the proposed assignee or sublessee, including but not limited to the intended use and/or required modification of the Premises, if any, together with a non-refundable deposit of $1,000 or ten percent (10%) of the monthly Base Rent applicable to the portion of the Premises which is the subject of the proposed assignment or sublease, whichever is greater, as reasonable consideration for Lessor's considering and processing the request for consent. Lessee agrees to provide Lessor with such other or additional information and/or documentation as may be reasonably requested by Lessor. (f) Any assignee of, or sublessee under, this Lease shall, by reason of accepting such assignment or entering into such sublease, be deemed, for the benefit of Lessor, to have assumed and agreed to conform and comply with each and every term, covenant, condition and obligation herein to be observed or performed by Lessee during the term of said assignment or sublease, other than such obligations as are contrary to or inconsistent with provisions of an assignment or sublease to which Lessor has specifically consented in writing. Initials: ----------------- ----------------- -6- 7 (g) The occurrence of a transaction described in Paragraph 12.2(c) shall give Lessor the right (but not the obligation) to require that the Security Deposit be increased by an amount equal to six (6) times the then monthly Base Rent, and Lessor may make the actual receipt by Lessor of the Security Deposit increase a condition to Lessor's consent to such transaction. (h) Lessor, as a condition to giving its consent to any assignment or subletting, may require that the amount and adjustment schedule of the rent payable under this Lease be adjusted to what is then the market value and/or adjustment schedule for property similar to the Premises as then constituted, as determined by Lessor. 12.3 ADDITIONAL TERMS AND CONDITIONS APPLICABLE TO SUBLETTING. The following terms and conditions shall apply to any subletting by Lessee of all or any part of the Premises and shall be deemed included in all subleases under this Lease whether or not expressly incorporated therein: (a) Lessee hereby assigns and transfers to Lessor all of Lessee's interest in all rentals and income arising from any sublease of all or a portion of the Premises heretofore or hereafter made by Lessee, and Lessor may collect such rent and income and apply same toward Lessee's obligations under this Lease; provided, however, that until a Breach (as defined in Paragraph 13.1) shall occur in the performance of Lessee's obligations under this Lease, Lessee may, except as otherwise provided in this Lease, receive, collect and enjoy the rents accruing under such sublease. Lessor shall not, by reason of the foregoing provision or any other assignment of such sublease to Lessor, nor by reason of the collection of the rents from a sublessee, be deemed liable to the sublessee for any failure of Lessee to perform and comply with any of Lessee's obligations to such sublessee under such Sublease. Lessee hereby irrevocably authorizes and directs any such sublessee, upon receipt of a written notice from Lessor stating that a Breach exists in the performance of Lessee's obligations under this Lease, to pay to Lessor the rents and other charges due and to become due under the sublease. Sublessee shall rely upon any such statement and request from Lessor and shall pay such rents and other charges to Lessor without any obligation or right to inquire as to whether such Breach exists and notwithstanding any notice from or claim from Lessee to the contrary. Lessee shall have no right or claim against such sublessee, or, until the Breach has been cured, against Lessor, for any such rents and other charges so paid by said sublessee to Lessor. (b) In the event of a Breach by Lessee in the performance of its obligations under this Lease, Lessor, at its option and without any obligation to do so, may require any sublessee to attorn to Lessor, in which event Lessor shall undertake the obligations of the sublessor under such sublease from the time of the exercise of said option lo the expiration of such sublease; provided, however, Lessor shall not be liable for any prepaid rents or security deposit paid by such sublessee to such sublessor or for any other prior defaults or breaches of such sublessor under such sublease. (c) Any matter or thing requiring the consent of the sublessor under a sublease shall also require the consent of Lessor herein. (d) No sublessee under a sublease approved by Lessor shall further assign or sublet all or any part of the Premises without Lessor's prior written consent. (e) Lessor shall deliver a copy of any notice of Default or Breach by Lessee to the sublessee, who shall have the right to cure the Default of Lessee within the grace period, if any, specified in such notice. The sublessee shall have a right of reimbursement and offset from and against Lessee for any such Defaults cured by the sublessee. 13. DEFAULT; BREACH; REMEDIES. 13.1 DEFAULT; BREACH. Lessor and Lessee agree that if an attorney is consulted by Lessor in connection with a Lessee Default or Breach (as hereinafter defined), $350.00 is a reasonable minimum sum per such occurrence for legal services and costs in the preparation and service of a notice of Default, and that Lessor may include the cost of such services and costs in said notice as rent due and payable to cure said default. A "DEFAULT" by Lessee is defined as a failure by Lessee to observe, comply with or perform any of the terms, covenants, conditions or rules applicable to Lessee under this Lease. A "BREACH" by Lessee is defined as the occurrence of any one or more of the following Defaults, and, where a grace period for cure after notice is specified herein, the failure by Lessee to cure such Default prior to the expiration of the applicable grace period, and shall entitle Lessor to pursue the remedies set forth in Paragraphs 13.2 and/or 13.3: (a) The vacating of the Premises without the intention to reoccupy same, or the abandonment of the Premises. (b) Except as expressly otherwise provided in this Lease, the failure by Lessee to make any payment of Base Rent, Lessee's Share of Common Area Operating Expenses, or any other monetary payment required to be made by Lessee hereunder as and when due, the failure by Lessee to provide Lessor with reasonable evidence of insurance or surety bond required under this Lease, or the failure of Lessee to fulfill any obligation under this Lease which endangers or threatens life or property, where such failure continues for a period of three (3) days following written notice thereof by or on behalf of Lessor to Lessee. (c) Except as expressly otherwise provided in this Lease, the failure by Lessee to provide Lessor with reasonable written evidence (in duly executed original form, if applicable) of (i) compliance with Applicable Requirements per Paragraph 6.3, (ii) the inspection, maintenance and service contracts required under Paragraph 7.1 (b), (iii) the rescission of an unauthorized assignment or subletting per Paragraph 12. 1, (iv) a Tenancy Statement per Paragraphs 16 or 37, (v) the subordination or non-subordination of this Lease per Paragraph 30, (vi) the guaranty of the performance of Lessee's obligations under this Lease if required under Paragraphs 1.11 and 37, (vii) the execution of any document requested under Paragraph 42 (easements), or (viii) any other documentation or information which Lessor may reasonably require of Lessee under the terms of this lease, where any such failure continues for a period of ten (10) days following written notice by or on behalf of Lessor to Lessee. (d) A Default by Lessee as to the terms, covenants, conditions or provisions of this Lease, or of the rules adopted under Paragraph 40 hereof that are to be observed, complied with or performed by Lessee, other than those described in Subparagraphs 13.1 (a), (b) or (c), above, where such Default continues for a period of thirty (30) days after written notice thereof by or on behalf of Lessor to Lessee; provided, however, that if the nature of Lessee's Default is such that more than thirty (30) days are reasonably required for its cure, then it shall not be deemed to be a Breach of this Lease by Lessee if Lessee commences such cure within said thirty (30) day period and thereafter diligently prosecutes such cure to completion. (e) The occurrence of any of the following events: (i) the making by Lessee of any general arrangement or assignment for the benefit of creditors; (iii) Lessee's becoming a "debtor" as defined in 11 U.S. Code Section 101 or any successor statute thereto (unless, in the case of a petition filed against Lessee, the same is dismissed within sixty (60) days); (iii) the appointment of a trustee or receiver to take possession of substantially all of Lessee's assets located at the Premises or of Lessee's interest in this Lease, where possession is not restored to Lessee within thirty (30) days; or (iv) the attachment, execution or other judicial seizure of substantially all of Lessee's assets located at the Premises or of Lessee's interest in this Lease, where such seizure is not discharged within thirty (30) days; provided, however, in the event that any provision of this Subparagraph 13.1(e) is contrary to any applicable law, such provision shall be of no force or effect, and shall not affect the validity of the remaining provisions. (f) The discovery by Lessor that any financial statement of Lessee or of any Guarantor, given to Lessor by Lessee or any Guarantor, was materially false. (g) If the performance of Lessee's obligations under this Lease is guaranteed: (i) the death of a Guarantor, (ii) the termination of a Guarantor's liability with respect to this Lease other than in accordance with the terms of such guaranty, (iii) a Guarantor's becoming insolvent or the subject of a bankruptcy filing, (iv) a Guarantor's refusal to honor the guaranty, or (v) a Guarantor's breach of its guaranty obligation on an anticipatory breach basis, and Lessee's failure, within sixty (60) days following written notice by or on behalf of Lessor to Lessee of any such event, to provide Lessor with written alternative assurances of security, which, when coupled with the then existing resources of Lessee, equals or exceeds the combined financial resources of Lessee and the Guarantors that existed at the time of execution of this Lease. 13.2 REMEDIES. If Lessee fails to perform any affirmative duty or obligation of Lessee under this Lease, within ten (10) days after written notice to Lessee (or in case of an emergency, without notice), Lessor may at its option (but without obligation to do so), perform such duty or obligation on Lessee's behalf, including but not limited to the obtaining of reasonably required bonds, insurance policies, or governmental licenses, permits or approvals. The costs and expenses of any such performance by Lessor shall be due and payable by Lessee to Lessor upon invoice therefor. If any check given to Lessor by Lessee shall not be honored by the bank upon which it is drawn, Lessor, at its own option, may require all future payments to be made under this Lease by Lessee to be made only by cashier's check. In the event of a Breach of this Lease by Lessee (as defined in Paragraph 13.1), with or without further notice or demand, and without limiting Lessor in the exercise of any right or remedy which Lessor may have by reason of such Breach, Lessor may: (a) Terminate Lessee's right to possession of the Premises by any lawful means, in which case this Lease and the term hereof shall terminate and Lessee shall immediately surrender possession of the Premises to Lessor. In such event Lessor shall be entitled to recover from Lessee: (i) the worth at the time of the award of the unpaid rent which had been earned at the time of termination; (ii) the worth at the time of award of the amount by which the unpaid rent which would have been earned after termination until the time of award exceeds the amount of such rental loss that the Lessee proves could have been reasonably avoided; (iii) the worth at the time of award of the amount by which the unpaid rent for the balance of the term after the time of award exceeds the amount of such rental loss that the Lessee proves could be reasonably avoided; and (iv) any other amount necessary to compensate Lessor for all the detriment proximately caused by the Lessee's failure to perform its obligations under this Lease or which in the ordinary course of things would be likely to result therefrom, including but not limited to the cost of recovering possession of the Premises, expenses of reletting, including necessary renovation and alteration of the Premises, reasonable attorneys' fees, and that portion of any leasing commission paid by Lessor in connection with this Lease applicable to the unexpired term of this Lease. The worth at the time of award of the amount referred to in provision (iii) of the immediately preceding sentence shall be computed by discounting such amount at the discount rate of the Federal Reserve Bank of San Francisco or the Federal Reserve Bank District in which the Premises are located at the time of award plus one percent (1%). Efforts by Lessor to mitigate damages caused by Lessee's Default or Breach of this Lease shall not waive Lessor's right to recover damages under this Paragraph 13.2. If termination of this Lease is obtained through the provisional remedy of unlawful detainer, Lessor shall have the right to recover in such proceeding the unpaid rent and damages as are recoverable therein, or Lessor may reserve the right to recover all or any part thereof in a separate suit for such rent and/or damages. If a notice and grace period required under Subparagraph 13.1 (b), (c) or (d) was not previously given, a notice to pay rent or quit, or to perform or quit, as the case may be, given to Lessee under any statute authorizing the forfeiture of leases for unlawful detainer shall also constitute the applicable notice for grace period purposes required by Subparagraph 13.1 (b), (c) or (d). In such case, the applicable grace period under the unlawful detainer statue shall run concurrently after the one such statutory notice, and the failure of Lessee to cure the Default within the greater of the two (2) such grace periods shall constitute both an unlawful detainer and a Breach of this Lease entitling Lessor to the remedies provided for in this Lease and/or by said statute. (b) Continue the Lease and Lessee's right to possession in effect (in California under California Civil Code Section 1951.4) after Lessee's Breach and recover the rent as it becomes due, provided Lessee has the right to sublet or assign, subject only to reasonable limitations. Lessor and Lessee agree that the limitations on assignment and subletting in this Lease are reasonable. Acts of maintenance or preservation, efforts to relet the Premises, or the appointment of a receiver to protect the Lessor's interest under this Lease, shall not constitute a termination of the Lessee's right to possession. (c) Pursue any other remedy now or hereafter available to Lessor under the laws or judicial decisions of the state wherein the Premises are located. MULTI-TENANT-MODIFIED NET Initials:____ American Industrial Real Estate Association 1993 ____ -7- 8 (d) The expiration or termination of this Lease and/or the termination of Lessee's right to possession shall not relieve Lessee from liability under any indemnity provisions of this Lease as to matters occurring or accruing during the term hereof or by reason of Lessee's occupancy of the Premises. 13.3 INDUCEMENT RECAPTURE IN EVENT OF BREACH. Any agreement by Lessor for free or abated rent or other charges applicable to the Premises, or for the giving or paying by Lessor to or for Lessee of any cash or other bonus, inducement or consideration for Lessee's entering into this Lease, all of which concessions are hereinafter referred to as "INDUCEMENT PROVISIONS" shall be deemed conditioned upon Lessee's full and faithful performance of all of the terms, covenants and conditions of this Lease to be performed or observed by Lessee during the term hereof as the same may be extended. Upon the occurrence of a Breach (as defined in Paragraph 13.1) of this Lease by Lessee, any such Inducement Provision shall automatically be deemed deleted from this Lease and of no further force or effect, and any rent, other charge, bonus, inducement or consideration theretofore abated, given or paid by Lessor under such an Inducement Provision shall be immediately due and payable by Lessee to Lessor, and recoverable by Lessor, as additional rent due under this Lease, notwithstanding any subsequent cure of said Breach by Lessee. The acceptance by Lessor of rent or the cure of the Breach which initiated the operation of this Paragraph 13.3 shall not be deemed a waiver by Lessor of the provisions of this Paragraph 13.3 unless specifically so stated in writing by Lessor at the time of such acceptance. 13.4 LATE CHARGES. Lessee hereby acknowledges that late payment by Lessee to Lessor of rent and other sums due hereunder will cause Lessor to incur costs not contemplated by this Lease, the exact amount of which will be extremely difficult to ascertain. Such costs include, but are not limited to, processing and accounting charges, and late charges which may be imposed upon Lessor by the terms of any ground lease, mortgage or deed of trust covering the Premises. Accordingly, if any installment of rent or other sum due from Lessee shall not be received by Lessor or Lessor's designee within ten (10) days after such amount shall be due, then, without any requirement for notice to Lessee, Lessee shall pay to Lessor a late charge equal to six percent (6%) of such overdue amount. The parties hereby agree that such late charge represents a fair and reasonable estimate of the costs Lessor will incur by reason of late payment by Lessee. Acceptance of such late charge by Lessor shall in no event constitute a waiver of Lessee's Default or Breach with respect to such overdue amount, nor prevent Lessor from exercising any of the other rights and remedies granted hereunder. In the event that a late charge is payable hereunder, whether or not collected, for three (3) consecutive installments of Base Rent, then notwithstanding Paragraph 4.1 or any other provision of this Lease to the contrary, Base Rent shall, at Lessor's option, become due and payable quarterly in advance. 13.5 BREACH BY LESSOR. Lessor shall not be deemed in breach of this Lease unless Lessor fails within a reasonable time to perform an obligation required to be performed by Lessor. For purposes of this Paragraph 13.5, a reasonable time shall in no event be less than thirty (30) days after receipt by Lessor, and by any Lender(s) whose name and address shall have been furnished to Lessee in writing for such purpose, of written notice specifying wherein such obligation of Lessor has not been performed; provided, however, that if the nature of Lessor's obligation is such that more than thirty (30) days after such notice are reasonably required for its performance, then Lessor shall not be in breach of this Lease if performance is commenced within such thirty (30) day period and thereafter diligently pursued to completion. 14. CONDEMNATION. If the Premises or any portion thereof are taken under the power of eminent domain or sold under the threat of the exercise of said power (all of which are herein called "condemnation"), this Lease shall terminate as to the part so taken as of the date the condemning authority takes title or possession, whichever first occurs. If more than ten percent (10%) of the floor area of the Premises, or more than twenty-five percent (25%) of the portion of the Common Areas designated for Lessee's parking, is taken by condemnation, Lessee may, at Lessee's option, to be exercised in writing within ten (10) days after Lessor shall have given Lessee written notice of such taking (or in the absence of such notice, within ten (10) days after the condemning authority shall have taken possession) terminate this Lease as of the date the condemning authority takes such possession. If Lessee does not terminate this Lease in accordance with the foregoing, this Lease shall remain in full force and effect as to the portion of the Premises remaining, except that the Base Rent shall be reduced in the same proportion as the rentable floor area of the Premises taken bears to the total rentable floor area of the Premises. No reduction of Base Rent shall occur if the condemnation does not apply to any portion of the Premises. Any award for the taking of all or any part of the Premises under the power of eminent domain or any payment made under threat of the exercise of such power shall be the property of Lessor, whether such award shall be made as compensation for diminution of value of the leasehold or for the taking of the fee, or as severance damages; provided, however, that Lessee shall be entitled to any compensation, separately awarded to Lessee for Lessee's relocation expenses and/or loss of Lessee's Trade Fixtures. In the event that this Lease is not terminated by reason of such condemnation, Lessor shall to the extent of its net severance damages received, over and above Lessee's Share of the legal and other expenses incurred by Lessor in the condemnation matter, repair any damage to the Premises caused by such condemnation authority. Lessee shall be responsible for the payment of any amount in excess of such net severance damages required to complete such repair, 16. TENANCY AND FINANCIAL STATEMENTS. 16.1 TENANCY STATEMENT. Each Party (as "RESPONDING PARTY") shall within ten (10) days after written notice from the other Party (the "Requesting Party") execute, acknowledge and deliver to the Requesting Party a statement in writing in a form similar to the then most current "Tenancy Statement" form published by the American Industrial Real Estate Association, plus such additional information, confirmation and/or statements as may be reasonably requested by the Requesting Party. 16.2 FINANCIAL STATEMENT. If Lessor desires to finance, refinance, or sell the Premises or the Building, or any part thereof, Lessee and all Guarantors shall deliver to any potential lender or purchaser designated by Lessor such financial statements of Lessee and such Guarantors as may be reasonably required by such lender or purchaser, including but not limited to Lessee's financial statements for the past three (3) years. All such financial statements shall be received by Lessor and such lender or purchaser in confidence and shall be used only for the purposes herein set forth. 17. LESSOR'S LIABILITY. The term "LESSOR" as used herein shall mean the owner or owners at the time in question of the fee title to the Premises. In the event of a transfer of Lessor's title or interest in the Premises or in this Lease, Lessor shall deliver to the transferee or assignee (in cash or by credit) any unused Security Deposit held by Lessor at the time of such transfer or assignment. Except as provided in Paragraph 15.3, upon such transfer or assignment and delivery of the Security Deposit, as aforesaid, the prior Lessor shall be relieved of all liability with respect to the obligations and/or covenants under this Lease thereafter to be performed by the Lessor. Subject to the foregoing, the obligations and/or covenants in this Lease to be performed by the Lessor shall be binding only upon the Lessor as hereinabove defined. 18. SEVERABILITY. The invalidity of any provision of this Lease, as determined by a court of competent jurisdiction, shall in no way affect the validity of any other provision hereof. 19. INTEREST ON PAST-DUE OBLIGATIONS. Any monetary payment due Lessor hereunder, other than late charges, not received by Lessor within ten (10) days following the date on which it was due, shall bear interest from the date due at the prime rate charged by the largest state chartered bank in the state in which the Premises are located plus four percent (4%) per annum, but not exceeding the maximum rate allowed by law, in addition to the potential late charge provided for in Paragraph 13.4. 20. TIME OF ESSENCE. Time is of the essence with respect to the performance of all obligations to be performed or observed by the Parties under this Lease. 21. RENT DEFINED. All monetary obligations of Lessee to Lessor under the terms of this Lease are deemed to be rent. 22. NO PRIOR OR OTHER AGREEMENTS; BROKER DISCLAIMER. This Lease contains all agreements between the Parties with respect to any matter mentioned herein, and no other prior or contemporaneous agreement or understanding shall be effective. 23. NOTICES. 23.1 NOTICE REQUIREMENTS. All notices required or permitted by this Lease shall be in writing and may be delivered in person (by hand or by messenger or courier service) or may be sent by regular, certified or registered mail or U.S. Postal Service Express Mail, with postage prepaid, or by facsimile transmission during normal business hours, and shall be deemed sufficiently given if served in a manner specified in this Paragraph 23. The addresses noted adjacent to a Party's signature on this Lease shall be that Party's address for delivery or mailing of notice purposes. Either Party may by written notice to the other specify a different address for notice purposes, except that upon Lessee's taking possession of the Premises, the Premises shall constitute Lessee's address for the purpose of mailing or delivering notices to Lessee. A copy of all notices required or permitted to be given to Lessor hereunder shall be concurrently transmitted to such party or parties at such addresses as Lessor may from time to time hereafter designate by written notice to Lessee. 23.2 DATE OF NOTICE. Any notice sent by registered or certified mail, return receipt requested, shall be deemed given on the date of delivery shown on the receipt card, or if no delivery date is shown, the postmark thereon. If sent by regular mail, the notice shall be deemed given forty-eight (48) hours after the same is addressed as required herein and mailed with postage prepaid. Notices delivered by United States Express Mail or overnight courier that guarantees next day MULTI-TENANT-MODIFIED NET Initials:____ American Industrial Real Estate Association 1993 ____ -8- 9 delivery shall be deemed given twenty-four (24) hours after delivery of the same to the United States Postal Service or courier. If any notice is transmitted by facsimile transmission or similar means, the same shall be deemed served or delivered upon telephone or facsimile confirmation of receipt of the transmission thereof, provided a copy is also delivered via delivery or mail. If notice is received on a Saturday or a Sunday or a legal holiday, it shall be deemed received on the next business day. 24. WAIVERS. No waiver by Lessor of the Default or Breach of any term, covenant or condition hereof by Lessee, shall be deemed a waiver of any other term, covenant or condition hereof, or of any subsequent Default or Breach by Lessee of the same or any other term, covenant or condition hereof. Lessor's consent to, or approval of, any such act shall not be deemed to render unnecessary the obtaining of Lessor's consent to, or approval of, any subsequent or similar act by Lessee, or be construed as the basis of an estoppel to enforce the provision or provisions of this Lease requiring such consent. Regardless of Lessor's knowledge of a Default or Breach at the time of accepting rent, the acceptance of rent by Lessor shall not be a waiver of any Default or Breach by Lessee of any provision hereof. Any payment given Lessor by Lessee may be accepted by Lessor on account of moneys or damages due Lessor, notwithstanding any qualifying statements or conditions made by Lessee in connection therewith, which such statements and/or conditions shall be of no force or effect whatsoever unless specifically agreed to in writing by Lessor at or before the time of deposit of such payment. 25. RECORDING. Either Lessor or Lessee shall, upon request of the other, execute, acknowledge and deliver to the other a short form memorandum of this Lease for recording purposes. The Party requesting recordation shall be responsible for payment of any fees or taxes applicable thereto. 26. NO RIGHT TO HOLDOVER. Lessee has no right to retain possession of the Premises or any part thereof beyond the expiration or earlier termination of this Lease. In the event that Lessee holds over in violation of this Paragraph 26 then the Base Rent payable from and after the time of the expiration or earlier termination of this Lease shall be increased to two hundred percent (200%) of the Base Rent applicable during the month immediately preceding such expiration or earlier termination. Nothing contained herein shall be construed as a consent by Lessor to any holding over by Lessee. 27. CUMULATIVE REMEDIES. No remedy or election hereunder shall be deemed exclusive but shall, wherever possible, be cumulative with all other remedies at law or in equity. 28. COVENANTS AND CONDITIONS. All provisions of this Lease to be observed or performed by Lessee are both covenants and conditions. 29. BINDING EFFECT; CHOICE OF LAW. This Lease shall be binding upon the Parties, their personal representatives, successors and assigns and be governed by the laws of the State in which the Premises are located. Any litigation between the Parties hereto concerning this Lease shall be initiated in the county in which the Premises are located. 30. SUBORDINATION; ATTORNMENT; NON-DISTURBANCE. 30.1 SUBORDINATION. This Lease and any Option granted hereby shall be subject and subordinate to any ground lease, mortgage, deed of trust, or other hypothecation or security device (collectively, "SECURITY DEVICE"), now or hereafter placed by Lessor upon the real property of which the Premises are a part, to any and all advances made on the security thereof, and to all renewals, modifications, consolidations, replacements and extensions thereof. Lessee agrees that the Lenders holding any such Security Device shall have no duty, liability or obligation to perform any of the obligations of Lessor under this Lease, but that in the event of Lessor's default with respect to any such obligation, Lessee will give any Lender whose name and address have been furnished Lessee in writing for such purpose notice of Lessor's default pursuant to Paragraph 13.5. If any Lender shall elect to have this Lease and/or any Option granted hereby superior to the lien of its Security Device and shall give written notice thereof to Lessee, this Lease and such Options shall be deemed prior to such Security Device, notwithstanding the relative dates of the documentation or recordation thereof. 30.2 ATTORNMENT. Subject to the non-disturbance provisions of Paragraph 30.3, Lessee agrees to attorn to a Lender or any other party who acquires ownership of the Premises by reason of a foreclosure of a Security Device, and that in the event of such foreclosure, such new owner shall not: (i) be liable for any act or omission of any prior lessor or with respect to events occurring prior to acquisition of ownership, (ii) be subject to any offsets or defenses which Lessee might have against any prior lessor, or (iii) be bound by prepayment of more than one month's rent. 30.3 NON-DISTURBANCE. With respect to Security Devices entered into by Lessor after the execution of this lease, Lessee's subordination of this Lease shall be subject to receiving assurance (a "non-disturbance agreement") from the Lender that Lessee's possession and this Lease, including any options to extend the term hereof, will not be disturbed so long as Lessee is not in Breach hereof and attorns to the record owner of the Premises. 30.4 SELF-EXECUTING. The agreements contained in this Paragraph 30 shall be effective without the execution of any further documents; provided, however, that upon written request from Lessor or a Lender in connection with a sale, financing or refinancing of Premises, Lessee and Lessor shall execute such further writings as may be reasonably required to separately document any such subordination or non-subordination, attornment and/or non-disturbance agreement as is provided for herein. 31. ATTORNEYS' FEES. If any Party or Broker brings an action or proceeding to enforce the terms hereof or declare rights hereunder, the Prevailing Party (as hereafter defined) in any such proceeding, action, or appeal thereon, shall be entitled to reasonable attorneys' fees. Such fees may be awarded in the same suit or recovered in a separate suit, whether or not such action or proceeding is pursued to decision or judgment. The term "Prevailing Party" shall include, without limitation, a Party or Broker who substantially obtains or defeats the relief sought, as the case may be, whether by compromise, settlement, judgment, or the abandonment by the other Party or Broker of its claim or defense. The attorneys' fee award shall not be computed in accordance with any court fee schedule, but shall be such as to fully reimburse all attorneys' fees reasonably incurred. Lessor shall be entitled to attorneys' fees, costs and expenses incurred in preparation and service of notices of Default and consultations in connection therewith, whether or not a legal action is subsequently commenced in connection with such Default or resulting Breach. Broker(s) shall be intended third party beneficiaries of this Paragraph 31. 32. LESSOR'S ACCESS; SHOWING PREMISES; REPAIRS. Lessor and Lessor's agents shall have the right to enter the Premises at any time, in the case of an emergency, and otherwise at reasonable times for the purpose of showing the same to prospective purchasers, lenders, or lessees, and making such alterations, repairs, improvements or additions to the Premises or to the Building, as Lessor may reasonably deem necessary. Lessor may at any time place on or about the Premises or Building any ordinary "For Sale" signs and Lessor may at any time during the last one hundred eighty (180) days of the term hereof place on or about the Premises any ordinary "For Lease" signs. All such activities of Lessor shall be without abatement of rent or liability to Lessee. 33. AUCTIONS. Lessee shall not conduct, nor permit to be conducted, either voluntarily or involuntarily, any auction upon the Premises without first having obtained Lessor's prior written consent. Notwithstanding anything to the contrary in this Lease, Lessor shall not be obligated to exercise any standard of reasonableness in determining whether to grant such consent. 34. SIGNS. Lessee shall not place any sign upon the exterior of the Premises or the Building, except that Lessee may, with Lessor's prior written consent, install (but not on the roof) such signs as are reasonably required to advertise Lessee's own business so long as such signs are in a location designated by Lessor and comply with Applicable Requirements and the signage criteria established for the Industrial Center by Lessor. The installation of any sign on the Premises by or for Lessee shall be subject to the provisions of Paragraph 7 (Maintenance, Repairs, Utility Installations, Trade Fixtures and Alterations). Unless otherwise expressly agreed herein, Lessor reserves all rights to the use of the roof of the Building, and the right to install advertising signs on the Building, including the roof, which do not unreasonably interfere with the conduct of Lessee's business; Lessor shall be entitled to all revenues from such advertising signs. 35. TERMINATION; MERGER. Unless specifically stated otherwise in writing by Lessor, the voluntary or other surrender of this Lease by Lessee, the mutual termination or cancellation hereof, or a termination hereof by Lessor for Breach by Lessee, shall automatically terminate any sublease or lesser estate in the Premises; provided, however, Lessor shall, in the event of any such surrender, termination or cancellation, have the option to continue any one or all of any existing subtenancies. Lessor's failure within ten (10) days following any such event to make a written election to the contrary by written notice to the holder of any such lesser interest, shall constitute Lessor's election to have such event constitute the termination of such interest. 36. CONSENTS. (a) Except for Paragraph 33 hereof (Auctions) or as otherwise provided herein, wherever in this Lease the consent of a Party is required to an act by or for the other Party, such consent shall not be unreasonably withheld or delayed. Lessor's actual reasonable costs and expenses (including but not limited to architects', attorneys', engineers' and other consultants' fees) incurred in the consideration of, or response to, a request by Lessee for any Lessor consent pertaining to this Lease or the Premises, including but not limited to consents to an assignment a subletting or the presence or use of a Hazardous Substance, shall be paid by Lessee to Lessor upon receipt of an invoice and supporting documentation therefor. In addition to the deposit described in Paragraph 12.2(e), Lessor may, as a condition to considering any such request by Lessee, require that Lessee deposit with Lessor an amount of money (in addition to the Security Deposit held under Paragraph 5) reasonably calculated by Lessor to represent the cost Lessor will incur in considering and responding to Lessee's request. Any unused portion of said deposit shall be refunded to Lessee without interest. Lessor's consent to any act, assignment of this Lease or subletting of the Premises by Lessee shall not constitute an acknowledgment that no Default or Breach by Lessee of this Lease exists, nor shall such consent be deemed a waiver of any then existing Default or Breach, except as may be otherwise specifically stated in writing by Lessor at the time of such consent. (b) All conditions to Lessor's consent authorized by this Lease are acknowledged by Lessee as being reasonable. The failure to specify herein any particular condition to Lessor's consent shall not preclude the impositions by Lessor at the time of consent of such further or other conditions as are then reasonable with reference to the particular matter for which consent is being given. 38. QUIET POSSESSION. Upon payment by Lessee of the rent for the Premises and the performance of all of the covenants, conditions and provisions on Lessee's part to be observed and performed under this Lease, Lessee shall have quiet possession of the Premises for the entire term hereof subject to all of the provisions of this Lease. MULTI-TENANT-MODIFIED NET Initials:____ (C) American Industrial Real Estate ____ Association 1993 -9- 10 40. RULES AND REGULATIONS. Lessee agrees that it will abide by, and keep and observe all reasonable rules and regulations ("Rules and Regulations") which Lessor may make from time to time for the management, safety, care, and cleanliness of the grounds, the parking and unloading of vehicles and the preservation of good order, as well as for the convenience of other occupants or tenants of the Building and the Industrial Center and their invitees. 41. SECURITY MEASURES. Lessee hereby acknowledges that the rental payable to Lessor hereunder does not include the cost of guard service or other security measures, and that Lessor shall have no obligation whatsoever to provide same. Lessee assumes all responsibility for the protection of the Premises, Lessee, its agents and invitees and their property from the acts of third parties. 42. RESERVATIONS. Lessor reserves the right, from time to time, to grant, without the consent or joinder of Lessee, such easements, rights of way, utility raceways, and dedications that Lessor deems necessary, and to cause the recordation of parcel maps and restrictions, so long as such easements, rights of way, utility raceways, dedications, maps and restrictions do not reasonably interfere with the use of the Premises by Lessee. Lessee agrees to sign any documents reasonably requested by Lessor to effectuate any such easement rights, dedication, map or restrictions. 43. PERFORMANCE UNDER PROTEST. If at any time a dispute shall arise as to any amount or sum of money to be paid by one Party to the other under the provisions hereof, the Party against whom the obligation to pay the money is asserted shall have the right to make payment "under protest" and such payment shall not be regarded as a voluntary payment and there shall survive the right on the part of said Party to institute suit for recovery of such sum. If it shall be adjudged that there was no legal obligation on the part of said Party to pay such sum or any part thereof, said Party shall be entitled to recover such sum or so much thereof as it was not legally required to pay under the provisions of this Lease. 44. AUTHORITY. If either Party hereto is a corporation, trust, or general or limited partnership, each individual executing this Lease on behalf of such entity represents and warrants that he or she is duly authorized to execute and deliver this Lease on its behalf. If Lessee is a corporation, trust or partnership, Lessee shall, within thirty (30) days after request by Lessor, deliver to Lessor evidence satisfactory to Lessor of such authority. 45. CONFLICT. Any conflict between the printed provisions of this Lease and the typewritten or handwritten provisions shall be controlled by the typewritten or handwritten provisions. 46. OFFER. Preparation of this Lease by either Lessor or Lessee or Lessor's agent or Lessee's agent and submission of same to Lessee or Lessor shall not be deemed an offer to lease. This Lease is not intended to be binding until executed and delivered by all Parties hereto. 47. AMENDMENTS. This Lease may be modified only in writing, signed by the parties in interest at the time of the modification. The Parties shall amend this Lease from time to time to reflect any adjustments that are made to the Base Rent or other rent payable under this Lease. As long as they do not materially change Lessee's obligations hereunder, Lessee agrees to make such reasonable non-monetary modifications to this Lease as may be reasonably required by an institutional insurance company or pension plan Lender in connection with the obtaining of normal financing or refinancing of the property of which the Premises are a part. 48. MULTIPLE PARTIES. Except as otherwise expressly provided herein, if more than one person or entity is named herein as either Lessor or Lessee, the obligations of such multiple parties shall be the joint and several responsibility of all persons or entities named herein as such Lessor or Lessee. Initials: _______ MULTI-TENANT-MODIFIED NET _______ (C)American Industrial Real Estate Association 1993 -10- 11 LESSOR AND LESSEE HAVE CAREFULLY READ AND REVIEWED THIS LEASE AND EACH TERM AND PROVISION CONTAINED HEREIN, AND BY THE EXECUTION OF THIS LEASE SHOW THEIR INFORMED AND VOLUNTARY CONSENT THERETO. THE PARTIES HEREBY AGREE THAT, AT THE TIME THIS LEASE IS EXECUTED, THE TERMS OF THIS LEASE ARE COMMERCIALLY REASONABLE AND EFFECTUATE THE INTENT AND PURPOSE OF LESSOR AND LESSEE WITH RESPECT TO THE PREMISES. IF THIS LEASE HAS BEEN FILLED IN, IT HAS BEEN PREPARED FOR YOUR ATTORNEY'S REVIEW AND APPROVAL. FURTHER, EXPERTS SHOULD BE CONSULTED TO EVALUATE THE CONDITION OF THE PROPERTY FOR THE POSSIBLE PRESENCE OF ASBESTOS, UNDERGROUND STORAGE TANKS OR HAZARDOUS SUBSTANCES. NO REPRESENTATION OR RECOMMENDATION IS MADE BY THE AMERICAN INDUSTRIAL REAL ESTATE ASSOCIATION OR BY THE REAL ESTATE BROKERS OR THEIR CONTRACTORS, AGENTS OR EMPLOYEES AS TO THE LEGAL SUFFICIENCY, LEGAL EFFECT, OR TAX CONSEQUENCES OF THIS LEASE OR THE TRANSACTION TO WHICH IT RELATES; THE PARTIES SHALL RELY SOLELY UPON THE ADVICE OF THEIR OWN COUNSEL AS TO THE LEGAL AND TAX CONSEQUENCES OF THIS LEASE. IF THE SUBJECT PROPERTY IS IN A STATE OTHER THAN CALIFORNIA, AN ATTORNEY FROM THE STATE WHERE THE PROPERTY IS LOCATED SHOULD BE CONSULTED. The parties hereto have executed this Lease at the place and on the dates specified above their respective signatures. Executed at: Sylmar, California Executed at: Sylmar, California ----------------------- ----------------------- on: on: -------------------------------- -------------------------------- By LESSOR: By LESSEE: MiniMed Inc. Alfred E. Mann - ------------------------------------ ------------------------------------ - ------------------------------------ ------------------------------------ By: /s/ KEVIN R. SAYER By: /s/ ALFRED E. MANN -------------------------------- -------------------------------- Name Printed: Kevin R. Sayer Name printed: Alfred E. Mann ---------------------- ---------------------- Title: Vice President, Finance Title: ------------------------------ ----------------------------- By: By: -------------------------------- -------------------------------- Name Printed: Name printed: ---------------------- ---------------------- Title: Title: ------------------------------ ----------------------------- Address: Address: --------------------------- --------------------------- - ------------------------------------ ------------------------------------ Telephone: (818) 362-5958 Telephone: (818) 789-9555 ------------------------- ------------------------- Facsimile: (818) 367-1485 Facsimile: (818) 788-7141 ------------------------- ------------------------- BROKER: BROKER: Executed at: Executed at: ----------------------- ----------------------- on: on: -------------------------------- -------------------------------- By: By: -------------------------------- -------------------------------- Name Printed: Name printed: ---------------------- ---------------------- Title: Title: ------------------------------ ----------------------------- Address: Address: --------------------------- --------------------------- - ------------------------------------ ------------------------------------ Telephone: ( ) Telephone: ( ) ------------------------- ------------------------- Facsimile: ( ) Facsimile: ( ) ------------------------- ------------------------- NOTE: These forms are often modified to meet changing requirements of law and needs of the industry. Always write or call to make sure you are utilizing the most current form: AMERICAN INDUSTRIAL REAL ESTATE ASSOCIATION, 345 S. Figueroa St., M-1, Los Angeles, CA 90071. (213) 687-8777. MULTI-TENANT-MODIFIED NET Initials:____ (C) American Industrial Real Estate ____ Association 1993 (C) 1993 by American Industrial Real Estate Association. All rights reserved. No part of these words may be reproduced in any form without permission in writing. -11- 12 RIDER 12. 1 (f) 12. 1 (f). Lessee may sublet this Lease to the Alfred E. Mann Foundation, provided that the such sublease is on a rent free basis to the sublessee 13 [SCHEMATIC DRAWING OF MINIMED BUILDING 3] 14 AMENDMENT This Amendment is effective as of July 1, 1996, by and between MiniMed Inc., a Delaware corporation ("Lessor") and Alfred E. Mann ("Lessee"). A. Lessor and Lessee entered into that certain Standard Industrial/Commercial Multi-Tenant Lease commencing as of August 1, 1995 (the "Lease"). (Capitalized terms used but not defined herein have the meanings set forth in the Lease.) B. The parties desire to amend the Lease to provide for additional space, improvements, certain modified terms and related items. IN CONSIDERATION OF THE ABOVE RECITALS, AND FOR OTHER GOOD AND VALUABLE CONSIDERATION, THE RECEIPT AND SUFFICIENCY WHICH ARE HEREBY ACKNOWLEDGED, THE PARTIES AGREE AS FOLLOWS: 1. The Premises which are the subject of this Lease, is that area commonly referred to as NAMF Building 4, together with that certain clean room consisting of approximately 820 square feet in NAMF Building 3, all as described in Exhibit A hereto, and the Lease is hereby amended to reflect the modified definition of the Premises. 2. The term of the Lease hereby is extended to and for a period of sixty (60) months from the effective date of this Amendment, and the Lease shall expire on June 30, 2001, subject to earlier termination as provided for herein. 3. Section 1.5 hereby is amended to provide that the "Base Rent" shall, effective July 1, 1996 and continuing until the Expiration Date, equal $12,474 per month, which amount shall be payable on the first day of each month commencing July 1, 1996. 4. Section 1.6(b) hereby is amended to provide that Lessee's Share of operating expense shall be 13.8%. 5. Section 1.8 is hereby amended to provide that permitted uses shall consist of the operation of facilities related to the research, design, development, manufacturing and distribution of medical products and supplies, and activities related or incidental thereto. 6. Section 12.1(f) is hereby amended and replaced in its entirety as follows: "Lessee may sublet this Lease (i) to the Alfred E. Mann Foundation, provided that such sublease is on a rent free basis or (ii) to Medical Research Group LLC, on such terms as Lessee and such subtenant may determine. Notwithstanding the foregoing, as a condition to Lessor Lease Amendment, Page 1 of 2 15 agreeing to such right to sublet, such subtenants shall acknowledge and agree to be bound by the terms of the Lease." 7. Notwithstanding anything to the contrary contained herein (including, without limitation, Section 2 of this Amendment) either party may terminate this Lease, effective at the end of any calendar year during the term hereof, by providing written notice to the other at least ninety (90) days prior to the end of any calendar year hereunder. In the event Lessee shall effect such termination, Lessee shall nonetheless continue to be responsible and liable for monthly payments to Lessor equal to the unamortized portion of tenant improvements made to the Premises, in an amount equal to $4,050 per month, until such time as Lessor actually occupies the Premises and utilizes such improvements. 8. Except as otherwise expressly provided for herein, the Lease shall remain in full force and effect and shall remain unchanged hereby. IN WITNESS WHEREOF, the undersigned have executed this Amendment, which shall be effective as of July 1, 1996. MiniMed Inc. By: /s/ KEVIN R. SAYER By: /s/ ALFRED E. MANN --------------------- --------------------- Kevin R. Sayer Alfred E. Mann Senior Vice President, Finance and Chief Financial Officer The undersigned agree to be bound by all of the terms, covenants, conditions and limitations of the Lease, as amended. Alfred E. Mann Foundation Medical Research Group, LLC By: /s/ JOE SCHULMAN By: /s/ RONALD R. LEBEL ---------------------- ---------------------- Vice President President Lease Amendment, Page 2 of 2 EX-11.1 5 STATEMENT RE COMPUTATION OF PER SHARE EARNINGS 1 EXHIBIT 11.1 MINIMED INC. STATEMENT OF COMPUTATION OF NET INCOME (LOSS) PER SHARE
YEAR ENDED YEAR ENDED YEAR ENDED DECEMBER 31, DECEMBER 29, DECEMBER 27, ------------ ------------ ------------ 1994 1995 1996 ------------ ------------ ------------ Weighted average common shares outstanding............ 7,768,000 9,293,000 11,566,000 Common equivalent shares from stock options and warrants............................................ 206,000 646,000 672,000 Redeemable convertible preferred stock................ 1,111,000 648,000 --------- ---------- ---------- Shares used in per share calculation.................. 9,085,000 10,587,000 12,238,000 ========= ========== ========== Net income (loss)..................................... $ (900,000) $1,809,000 $4,672,000 ========= ========== ========== Net income (loss) per share........................... $(.10) $.17 $.38 ========= ========== ==========
EX-21.1 6 SUBSIDIARIES OF THE COMPANY 1 EXHIBIT 21.1 Subsidiaries of the Company MiniMed SA, a French company MiniMed GmbH, a German company MiniMed International, Inc., a Barbados company MiniMed Distribution Corp., a Delaware company EX-23.1 7 CONSENT OF DELOITTE & TOUCHE LLP 1 EXHIBIT 23.1 INDEPENDENT AUDITORS' CONSENT AND REPORT ON SCHEDULE We consent to the use in the Registration Statement No. 333-23013 of MiniMed Inc. on Form S-3 of our report dated January 17, 1997 (February 20, 1997 as to the last paragraph of note 3) appearing in the Prospectus, which is a part of that Registration Statement, to the reference to us under the headings "Selected Consolidated Financial Data" and "Experts" in such Prospectus, and the incorporation by reference of our report dated January 17, 1997 (February 20, 1997 as to the last paragraph of note 3) appearing in this annual report on Form 10-K of MiniMed Inc. for the year ended December 27, 1996. Our audits of the financial statements referred to in our aforementioned report also included the financial statements schedule of MiniMed Inc., listed in Item 14. This financial statement schedule is the responsibility of the Company's management. Our responsibility is to express an opinion based on our audits. In our opinion, such financial statement schedule, when considered in relation to the basic financial statements taken as a whole, presents fairly in all material aspects the information set forth therein. /s/ Deloitte & Touche LLP Los Angeles, California March 21, 1997
-----END PRIVACY-ENHANCED MESSAGE-----