-----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, RG2pqg9wRpkmfSRNy/iFEsbhBVeNceZYUHWtR4Z0pVC20F9YI8RPNdkgmmb4Q2jK +oz1mF+vkNxQ52gc8MK91g== 0000893220-01-000240.txt : 20010307 0000893220-01-000240.hdr.sgml : 20010307 ACCESSION NUMBER: 0000893220-01-000240 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20001231 FILED AS OF DATE: 20010302 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ALTEON INC /DE CENTRAL INDEX KEY: 0000878903 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133304550 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: SEC FILE NUMBER: 001-16043 FILM NUMBER: 1560640 BUSINESS ADDRESS: STREET 1: 170 WILLIAMS DR CITY: RAMSEY STATE: NJ ZIP: 07446 BUSINESS PHONE: 2019345000 MAIL ADDRESS: STREET 1: 170 WILLIAMS DR CITY: RAMSEY STATE: NJ ZIP: 07446 10-K 1 w46067e10-k.txt FORM 10-K ALTEON INC. 1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2000, OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 0-19529 ALTEON INC. ------------------------------------ (Exact name of registrant as specified in its charter) DELAWARE 13-3304550 ------------------------------- -------------------------- (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 170 WILLIAMS DRIVE, RAMSEY, NEW JERSEY 07446 --------------------------------------------------------- (Address of principal executive offices) (Zip Code) (201)934-5000 ------------------------------------------------------ (Registrant's telephone number, including area code) Securities Registered Pursuant to Section 12(b) of the Act: Name of Exchange Title of Each Class On Which Registered - -------------------------------------- ----------------------- Common Stock, Par Value $.01 per share American Stock Exchange Securities Registered Pursuant to Section 12(g) of the Act: NONE Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No ----- ---- Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of Registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [ ] The aggregate market value of the equity stock held by non-affiliates of the Registrant, based on the American Stock Exchange closing price of the Common Stock ($4.35 per share), as of February 28, 2001, was $97,862,680. At February 28, 2001, 22,537,635 shares of the Registrant's Common Stock, par value $.01 per share, were outstanding. Documents Incorporated By Reference Document Where Incorporated - ------------------------------ ------------------ Proxy Statement for 2001 Part III Annual Meeting of Stockholders 2 PART 1 ITEM 1. BUSINESS. OVERVIEW We are a product-based biopharmaceutical company engaged in the discovery and development of oral drugs for the treatment of diseases of aging and diabetes. Our product candidates represent novel approaches to some of the largest pharmaceutical markets, such as cardiovascular and kidney diseases. Two of our compounds are in clinical development; several others are undergoing pre-clinical testing. These pharmaceutical candidates were developed as a result of our understanding of the Advanced Glycosylation End-product ("A.G.E.") pathway, a fundamental pathological process and inevitable consequence of aging that may result in many medical disorders. A.G.E.s are glucose/protein complexes that form as a result of circulating blood glucose reacting with proteins. These A.G.E. complexes subsequently interact and bond with other proteins (crosslink), resulting in "hardened" (stiffened) arteries, toughened tissues and impaired flexibility and function of many body organs. In healthy individuals, this pathological A.G.E.-formation process occurs slowly as the body ages. In diabetic patients, the rate of A.G.E. accumulation and the extent of protein crosslinking are accelerated because of high glucose levels. We believe that A.G.E.s are a major factor contributing to many of the disorders of aging and diabetes, including cardiovascular, kidney and eye diseases. Our current research and drug development activities targeting the A.G.E. pathway take three directions: the breaking of A.G.E. crosslinks between proteins in order to reverse damage (A.G.E. Crosslink Breakers); the prevention or inhibition of A.G.E. formation (A.G.E.-Formation Inhibitors); and the reduction of the A.G.E. burden through a novel class of anti-hyperglycemic agents, Glucose Lowering Agents, ("GLA"). We believe that we were the first company to focus on the development of compounds to treat diseases caused by A.G.E. formation and crosslinking. Since our inception, we have created an extensive library of novel compounds targeting the A.G.E. pathway, and have actively pursued patent protection for these discoveries. We have 98 issued United States patents and over 80 issued foreign patents focused primarily on A.G.E. technology. ALT-711 is our lead product candidate in a class of proprietary compounds known as A.G.E. Crosslink Breakers. ALT-711 offers the possibility of the first therapeutic approach to "breaking" A.G.E. crosslinks, the benefit of which may be to reverse tissue damage caused by aging and diabetes, thereby restoring flexibility and function. We are initially developing ALT-711 for the treatment of cardiovascular disease, and have completed a 93-patient, placebo-controlled safety, efficacy and pharmacology trial of ALT-711, known as a Phase IIa clinical trial. In January 2001, we announced that these study results showed that patients who received ALT-711 experienced a statistically significant (p less than or equal to 0.05) and clinically meaningful reduction in pulse pressure, defined as the difference between systolic and diastolic blood pressures. Results also showed a clinically meaningful increase in large artery compliance, an indicator of greater vascular flexibility and volume capacity. Additionally, the drug was well tolerated. The results of the Phase IIa trial were accepted to be presented at the Special Sessions Presentation of "Late Breaking Clinical Trials" at the American College of Cardiology Annual Scientific Session in March 2001. These positive results suggest that ALT-711 is a novel potential therapy for isolated systolic hypertension, a disease that occurs as a result of vascular stiffening due to age or diabetes. We plan to initiate a Phase IIb efficacy trial to further assess ALT-711's activity in isolated systolic hypertension ("ISH"). Additionally, we are evaluating potential clinical trials in other therapeutic indications where the compound may address significant unmet needs. We are actively evaluating product development opportunities from our library of compounds. Pimagedine, our clinical lead A.G.E.-Formation Inhibitor, and ALT-946, a pre-clinical lead second-generation A.G.E.-Formation Inhibitor, are being considered for further development. In addition, we are utilizing our technical expertise in the field of diabetes to develop compounds focused on glucose regulation and control. We are evaluating our lead GLA compounds to determine the most appropriate pre-clinical development course. We were incorporated in Delaware in October 1986 under the name Geritech Inc. Our name was changed to Alteon Inc. in August 1991. 2 3 OUR BUSINESS STRATEGY Our strategy is to develop drug candidates from our existing portfolio of new chemical entities. Because of the novel mechanism of action of our compounds, we are seeking to position these compounds to address large medical needs that are unmet by existing therapies. We will seek, as appropriate, to selectively out-license our drug candidates. As we continue clinical development of ALT-711, we will determine if it is appropriate to retain development and marketing rights for one or several indications in North America, while at the same time continuing to evaluate potential corporate partnerships for the further development and ultimate marketing of the compound. In addition to ALT-711, we have identified compounds in multiple chemical classes that we believe warrant further evaluation and potential development. MARKETS OF OPPORTUNITY The pre-clinical and clinical data generated to date on our A.G.E.-Formation Inhibitors and A.G.E. Crosslink Breakers demonstrates clear and consistent findings across several species, including rats, dogs, non-human primates and man. These development and research efforts have led us to an initial focus on cardiovascular disease, including ISH, as well as complications of diabetes. Targeting the A.G.E. pathway may impact a number of medical disorders related to aging and diabetes, thus potentially broadening our markets of opportunity. Cardiovascular Disease According to the American Heart Association, nearly 60 million Americans have one or more types of cardiovascular disease. Cardiovascular disease has been the number one killer of Americans since the early 1900's. The latest World Health Organization - International Society of Hypertension guidelines for the management of hypertension emphasize the importance of pulse pressure and arterial stiffness (hardening) as predictors of general cardiovascular risk. Currently available hypertensive agents reduce pressure on the vessel wall in such a manner as to lower both systolic and diastolic blood pressures without affecting pulse pressure. Our approach increases large arterial elasticity in such a manner as to increase the volume of the large artery and thereby reduce pulse pressure beyond what would be expected from restoring the dynamic range of the vessel wall with a reduction in blood pressure alone. Pharmacologic intervention targeting the stiffness of the cardiovascular system may decrease the incidence and severity of complications such as left ventricular hypertrophy and congestive heart failure. Published studies have shown that a 10mm Hg reduction in pulse pressure correlates with a 35% reduction in cardiovascular mortality. Isolated Systolic Hypertension ISH is defined as elevated systolic blood pressure (greater than 160mm Hg) accompanied by normal diastolic blood pressure (less than 90mm Hg). ISH, which affects over eight million Americans, is primarily a consequence of age-related stiffening of the large arteries. It is associated with a significantly increased risk of overall mortality, cardiovascular mortality and congestive heart failure and is not adequately treated by existing therapies. The ability of ALT-711 to decrease pulse pressure and increase large artery compliance (see "A.G.E. Crosslink Breakers - ALT-711") offers an opportunity to provide a treatment option specifically for ISH. Though other hypertensive agents are being used to treat ISH, ALT-711 is the first drug to show direct activity against this condition by targeting stiff vessel disease that causes this form of hypertension. We believe that because ALT-711 exerts its activity by a mechanism uniquely different from currently available therapies, its benefits will be over and above current standard treatment. Complications of Diabetes The Diabetes Control and Complications Trial ("DCCT"), a multi-center clinical trial conducted by the National Institutes of Health, demonstrated that elevated blood glucose levels significantly increase the rate of progression of eye, kidney, blood vessel and nerve complications from diabetes. More than 50% of people with diabetes in the United States develop diabetic complications that range from mild to severe. 3 4 Overt Nephropathy Kidney disease is a significant cause of morbidity and mortality in patients with Type 1 and Type 2 diabetes. It is a chronic and progressive disease. One of the early signs of kidney damage is microalbuminuria (characterized by leakage of small amounts of protein into the urine), which progresses to overt nephropathy (characterized by leakage of large amounts of protein into the urine) and ultimately to End-Stage Renal Disease ("ESRD"), advanced kidney disease requiring dialysis. Approximately 34% of patients with Type 1 diabetes and approximately 10-15% of patients with Type 2 diabetes develop nephropathy. As of 1995, there were approximately 1,000,000 diabetics diagnosed with kidney disease in the United States. In a Phase II/III trial in diabetic patients with overt nephropathy, the ACTION trial, Pimagedine therapy showed a statistically significant reduction in urinary protein excretion, though it did not reach statistical significance in its primary endpoint, the time to doubling of serum creatinine. In addition, our pre-clinical candidate, ALT-946, has shown a protective effect on the kidneys in a pre-clinical study. Retinopathy Approximately nine out of 10 people with diabetes eventually develop a complication that affects the eyes known as diabetic retinopathy. Retinopathy affects the blood vessels inside the eye and can lead to blindness. Each year, approximately 12,000 to 24,000 people lose their sight because of diabetes. The incidence and severity of retinopathy increases with the duration of diabetes. Though not a primary endpoint in the Phase II/III ACTION trial, Pimagedine therapy did result in a statistically significant reduction in the progression of retinopathy. In addition, we believe that ALT-711 may have an impact on retinopathy. Cardiovascular Disease A significant portion of diabetic individuals develops cardiovascular disease due to the high levels of blood glucose and A.G.E.s within the body. Other Diseases We are actively evaluating other potential indications for our compounds, including the treatment of patients on peritoneal dialysis, with urological conditions, scleroderma and other dermatologic conditions. OUR TECHNOLOGY: THE A.G.E. PATHWAY IN AGING AND DIABETES A.G.E.s are permanent glucose structures that form when glucose binds to the surface of proteins. As the body ages, A.G.E. complexes form on proteins continuously and naturally, though slowly, at a rate dependent upon glucose levels and on the body's natural ability to clear these pathological structures. A.G.E. complexes subsequently crosslink to other proteins, causing a progressive loss of flexibility and function in various tissues, blood vessels and organs. The formation and crosslinking of A.G.E.s is a well-known process in food chemistry, where it is called the Maillard Reaction. The toughening and discoloration of food during the cooking process and after prolonged storage occurs, in part, as a result of the formation of complexes between sugars and the amino acids of proteins. The harmful consequences of A.G.E. formation in man was proposed in 1986 by our scientific founders as an outgrowth of a research effort focused on diabetes. The A.G.E. crosslink has been found to be unique in biology and is prevalent in animal models of aging and diabetes. Scientific literature suggests that the formation and crosslinking of A.G.E.s is an inevitable part of the aging process that leads to a loss of flexibility and function in body tissues, organs and vessels. The A.G.E. pathway may provide the scientific explanation for how and why many of the medical complications of the aging process occur with higher frequency and earlier in life in diabetic patients. Diabetic individuals form excessive amounts of A.G.E.s earlier in life than do non-diabetic individuals, due primarily to higher levels of blood sugar. For this reason, diabetes may be viewed as an accelerated form of aging. 4 5 A.G.E.s and A.G.E. crosslinks are considered to be likely causative factors in the development of many age-related and diabetic disorders, including those associated with the cardiovascular and renal systems. For example, proteins in the body, such as collagen and elastin, which play an important role in maintaining the elasticity of the cardiovascular system, are prime targets for A.G.E. crosslinking. This mechanical process can impair the normal function of contractile organs, such as blood vessels and cardiac muscle, which depend on flexibility for normal function. Loss of flexibility of the vasculature may lead to a number of cardiovascular disorders including ISH, which creates increased workload for the heart and may lead to heart failure. The foundation for our technology is the experimental evidence that intervention and treatment along the pathway towards A.G.E. crosslink formation would be likely to provide significant benefit in slowing or reversing the development of the serious pathologies that develop in the diabetic and aging populations. ALT-711 and Pimagedine are the lead compounds resulting from our research in this field. Studies conducted in animal models of diabetes or aging at numerous independent institutions worldwide demonstrate that A.G.E.s are a major factor contributing to many of the disorders of aging and diabetes, including cardiovascular, kidney and eye diseases, as well as atherosclerosis. Recent human clinical studies we performed confirm that impacting the A.G.E. pathway can have a significant beneficial effect on such disease states. The following chart illustrates the process of A.G.E. formation and crosslinking and is qualified by the more detailed description in the text. It also highlights those areas within the A.G.E. cascade where we are attempting to offer pharmaceutical agents to intervene therapeutically. [ NOTE: THE PRINTED COPY OF THIS FORM 10-K CONTAINS A GRAPHICAL ] [ REPRESENTATION OF THE FOLLOWING. THE "I" REPRESENTS ARROWS ] [ POINTING FROM "GLUCOSE LOWERING AGENTS" TO "GLUCOSE + PROTEINS," ] [ FROM "A.G.E.-FORMATION AND CROSSLINK INHIBITORS" TO "A.G.E.S," AND ] [ FROM "A.G.E. CROSSLINK BREAKERS" TO "CROSSLINKED A.G.E.S" ] OUR TECHNOLOGY PLATFORM AND PRODUCT PIPELINE Glucose / Proteins ====> A.G.E.s ====> Crosslinked A.G.E.s I I I Glucose Lowering A.G.E. Formation A.G.E. Crosslink Agents and Crosslink Breakers Inhibitors - - New Chemical Class - 9 New Chemical Classes - 4 New Chemical Classes (51 Compounds) (852 Compounds) (375 Compounds) - - New Mechanism - New Mechanism - New Mechanism - Improves pancreas function - Blocks A.G.E. cascade - Breaks A.G.E. crosslinks - Increases insulin production - Improves kidney function - Restores vascular function - Restores insulin sensitivity - Effect additive to ACE - Restores heart function Inhibitors - Activity unlike any known drug Lead Compounds: ALT-4037 Pimagedine ALT-711 -------- ---------- ------- Pre-Clinical Lead Phase II/III Phase II Candidate Type II Diabetes Diabetic Disease Cardiovascular Disease ALT-946 ------- Pre-Clinical Lead
We incurred research and development expenditures of $6,022,000, $10,598,000 and $24,592,000 for the years ended December 31, 2000, 1999 and 1998, respectively. 5 6 A.G.E. Crosslink Breakers By "breaking" A.G.E. crosslinks, these novel classes of compounds may have an impact on a number of medical disorders where loss of flexibility or elasticity leads to a loss in function. Our lead clinical candidate, ALT-711, has demonstrated in a Phase IIa trial the ability to reverse tissue damage and restore function to the cardiovascular system. Additionally, we are evaluating development of the breaker class for several other indications where A.G.E.s and A.G.E. crosslinking lead to abnormal function. Early clinical experience in human studies of ALT-711 suggests that urinary elastic dysfunction (leading to urinary incontinence) is a potential therapeutic target. The scientific literature also points to the possible utility of breaker compounds in ophthalmic and dermatological conditions, stiff joint disorders and treatment of complications in patients undergoing peritoneal dialysis. We have identified four distinct chemical classes of A.G.E. crosslink breakers, and have a library of more than 375 compounds. ALT-711 Through its unique mechanism of action, ALT-711 is the first compound that breaks A.G.E.-derived crosslinks between proteins, both in vitro and in vivo. The compound is under Phase II clinical evaluation in cardiovascular disease, as well as in various pre-clinical models to assess its potential in a variety of disease states. Studies in animal models in several laboratories around the world have demonstrated rapid reversal of impaired cardiovascular functions with ALT-711. In these pre-clinical models, ALT-711 reverses the stiffening of arteries, as well as stiffening of the heart, that accompanies the development of aging and diabetes. Pre-clinical studies of ALT-711 conducted by researchers from The National Institute on Aging and Johns Hopkins Geriatric Center demonstrated the ability of the compound to significantly reduce arterial stiffness in elderly Rhesus monkeys. In this primate study, administration of ALT-711 every other day for three weeks was found to significantly reduce aortic stiffness with the maximum improvement in vessel wall flexibility occurring at the six-week evaluation after the end of treatment with ALT-711. Baseline weight, fasting blood glucose, creatinine and cholesterol did not change after treatment. In a pre-clinical study of ALT-711 in aged dogs, administration of ALT-711 for one month resulted in an approximate 40% decrease in age-related ventricular stiffness, or hardening of the heart. This decrease was accompanied by an overall improvement in cardiac function. Reductions in blood pressure that have been observed in animal models of diabetic hypertension suggest that ALT-711 also may prove beneficial in the treatment of systolic hypertension in the elderly or in the diabetic. ALT-711 is a small, easily synthesized compound with a rapid mode of action. It is well absorbed from an oral tablet formulation. Since June 1998, five Phase I safety and dose escalation studies have been conducted. These trials have shown the drug to be well tolerated. In April 2000, we initiated a Phase IIa clinical trial of ALT-711 at nine clinical sites in the United States to evaluate effects of the compound on the cardiovascular system. This trial was a double blind, placebo-controlled study evaluating the safety, efficacy and pharmacology of ALT-711. The trial enrolled 93 patients over the age of 50 with measurably stiffened cardiovasculature, including systolic blood pressure of at least 140mm Hg and pulse pressure of at least 60mm Hg. Patients were randomized to receive oral doses of either 210 mg of ALT-711 or placebo once daily for eight weeks. Patients were evaluated for cardiovascular elasticity and function as measured by pulse pressure, cardiovascular compliance, pulse wave velocity and cardiac output. Under this protocol, ALT-711 treatment was in addition to the best available therapeutic regimen chosen by the treating physicians. In January 2001, we announced that these study results showed that patients who received ALT-711 experienced a statistically significant (p[less than, equal to] 0.05) and clinically meaningful reduction in the arterial pulse pressure, defined as the difference between systolic and diastolic blood pressures. Results also showed a clinically meaningful increase in large artery compliance, an indicator of greater vascular flexibility and volume capacity, using a traditional measurement of the ratio of stroke volume to pulse pressure. Additionally, the drug was well tolerated. This Phase IIa data was accepted to be presented at the Special Sessions Presentation of "Late Breaking Clinical Trials" at the American College of Cardiology Annual Scientific Session in March 2001. 6 7 Based on the positive results of this trial, we plan to initiate a Phase IIb efficacy trial of ALT-711. The timing and extent of ALT-711's clinical development will be determined by our ability to secure additional financing. A.G.E.-Formation Inhibitors A.G.E.-formation inhibitors are designed to prevent glucose/protein formation and crosslinking. We believe that this class of compounds may have broad applications in slowing down the key complications of diabetes. We have identified nine distinct chemical classes of A.G.E.-formation inhibitors, encompassing a library in excess of 800 compounds. Further development of the A.G.E. inhibitor class of compounds is subject to further funding. Pimagedine Pimagedine is our lead compound in the A.G.E.-formation inhibitor class. We conducted a randomized double-blind, placebo-controlled, multi-center, Phase II/III clinical trial to evaluate the safety and efficacy of Pimagedine in Type 1 diabetic patients with overt nephropathy, the ACTION I trial. The primary objective of the trial was to evaluate the safety and efficacy of Pimagedine in preserving kidney function in Type 1 patients. The trial enrolled 690 patients at 56 investigational sites in the United States and Canada. Patients were treated for a minimum of two years and received twice daily oral doses of Pimagedine, adjusted for kidney function. Under this protocol, Pimagedine treatment was in addition to the best available therapeutic regimen chosen by the treating physicians. In November 1998, we announced results of an analysis of data from the ACTION I trial. Although the results showed that Pimagedine reduced the risk of doubling of serum creatinine, the study's primary endpoint, the data did not reach statistical significance. However, Pimagedine therapy did result in a statistically significant and clinically meaningful reduction of urinary protein excretion. Pimagedine also reduced, to a statistically significant extent, cholesterol and triglycerides as well as the progression of retinopathy. Additional data suggested a trend toward improvements in other measures of kidney function including estimated creatinine clearance and glomerular filtration rate. The drug was generally well tolerated. In addition to evaluating oral Pimagedine in overt nephropathy, we have completed acute toxicity studies in animals with an intravenous formulation of Pimagedine. Animal studies have demonstrated that Pimagedine, when given prior to or after indication of stroke by occlusion of the middle cerebral artery, reduced the volume of tissue death by 30%. We have filed an investigational new drug application ("IND") with the United States Food and Drug Administration ("FDA"). We are actively exploring partnering and regulatory pathways for the continued development of Pimagedine and expect to pursue development if funding is obtained. ALT-946 ALT-946 is the pre-clinical lead candidate in our A.G.E.- formation inhibitor class of compounds. A study of ALT-946 in diabetic rats demonstrated that ALT-946 had a protective effect on the kidneys, and that ALT-946 was more potent than Pimagedine in inhibiting A.G.E. crosslinking, both in vitro and in vivo. We continue to evaluate ALT-946 in pre-clinical testing. Glucose Lowering Agents High glucose levels (hyperglycemia of diabetes) accelerate the rate of A.G.E. formation and crosslinking. Controlling glucose levels has been shown to slow the rate of progression of diabetic complications. The GLA Program arose from a search of plant-derived natural products that would exhibit a beneficial profile of glucose and lipid lowering of Type 2 diabetes. Several pre-clinical candidates that display these beneficial properties have been evaluated. They have demonstrated the ability to lower glucose and lipids, restore insulin sensitivity and stimulate increased insulin production. We have identified one chemical class of GLA, which includes more than 50 compounds. 7 8 ALT-4037 ALT-4037 has been identified as the pre-clinical lead in the glucose lowering agent class of compounds. ALT-4037 is a novel compound that lowers glucose and lipids, restores normal pancreatic sensing of glucose, stimulates greater production of insulin and restores insulin sensitivity in skeletal muscle and fat in animal models of Type 2 diabetes. Additional development is subject to further funding. CORPORATE STRATEGIC ALLIANCES Yamanouchi We granted to Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi") an exclusive license to commercialize our A.G.E.-related technology in Japan, South Korea, Taiwan and The People's Republic of China (the "Yamanouchi Territory") in exchange for royalty payments on net sales, if any. Yamanouchi has the right to terminate the agreement upon 90 days' prior written notice. This license expires as to each product in each licensed country upon the later of 15 years from the date of the agreement, the expiration of the last patent applicable to the product or five years after the first commercial sale of the product in the country. Pursuant to the license agreement, we granted to Yamanouchi the right to manufacture Pimagedine bulk material for sale in the Yamanouchi Territory. Roche In December 1994, we entered into an exclusive licensing arrangement with Roche Diagnostics GmbH ("Roche") for our technology for diagnostic applications. Under this alliance, we will be entitled to receive royalties based on net sales of research and commercial assays developed by Roche and based on our A.G.E. technology. Roche received exclusive worldwide rights to the technology for diagnostic applications outside the Yamanouchi Territory. The agreement gives Roche discretion over commercial development of diagnostic applications. Roche may terminate the license agreement upon 90 days' prior written notice. Under the agreement, Roche agreed to develop immunoassays to detect A.G.E.-hemoglobin, ApoB-A.G.E. and A.G.E.-serum protein/peptides. Development of reagents and formats for the A.G.E. competitive ELISA and a procedure for measuring hemoglobin-A.G.E. was completed in 1998. This research assay is currently being evaluated at a number of institutes and medical universities in Germany. Continuation of the program to adapt these reagents to automated clinical assays is contingent upon FDA approval of Pimagedine and would advance along with any product launch of Pimagedine. Gamida In November 1995, we entered into clinical testing and distribution agreements with Gamida for Life ("Gamida"). Under these agreements, Gamida conducted, at its own expense, a Phase II multi-site clinical trial in Israel, in accordance with the protocol developed by us, to evaluate Pimagedine in patients with diabetes and elevated serum cholesterol levels. Gamida will receive the exclusive right to distribute Pimagedine, if successfully developed and approved for marketing, in Israel, Bulgaria, Cyprus, Jordan and South Africa. The distribution agreement is for a term ending 10 years after the date of regulatory approval for the sale of Pimagedine in Israel; thereafter, it will be automatically renewed for successive three-year periods unless terminated by either party on the last day of the initial or renewal term. IDEXX In June 1997, we entered into a license and supply agreement with IDEXX Laboratories, Inc. ("IDEXX"), pursuant to which we licensed Pimagedine to IDEXX as a potential therapeutic in companion animals (dogs, cats and horses) and its A.G.E. diagnostics technology for companion animal use. IDEXX will be responsible for the development, licensing and marketing of Pimagedine and A.G.E. diagnostics for such use on a worldwide basis. We will be entitled to receive milestone payments and royalties on sales of the licensed products. To date, IDEXX has not developed any such products. 8 9 HemoMax In October 2000, we entered into an agreement with HemoMax, LLC ("HemoMax") for the development of a novel technology designed to increase the delivery of oxygen to tissues in the body through enhanced blood circulation. Under the agreement, HemoMax will fund the pre-clinical development of compounds arising from the technology, and we will directly manage the development programs. HemoMax has granted us an exclusive right of first refusal to acquire the HemoMax technology. In addition, based on the achievement of certain milestones, we will receive 15% ownership of HemoMax. While this technology is not currently a part of our main technology platform, we entered into this relationship because it represents an opportunity to participate in the development of and potentially acquire a technology that complements our cardiovascular activities with ALT-711. ACADEMIC RESEARCH AND LICENSE AGREEMENTS Washington University, St. Louis In June 1995, we obtained an exclusive, worldwide, royalty-bearing license from Washington University for patents covering the use of Pimagedine as an inhibitor of inducible nitric oxide synthase ("iNOS"). The agreement requires us to pay certain licensing fees upon the attainment of development milestones as well as a royalty on net sales or a share of sub-licensing profits on products covered by the patents. The license also covers patents developed through any subsequent research collaboration between the parties that we agree to fund. The Rockefeller University Pursuant to an agreement with Rockefeller University, we have exclusive, worldwide and perpetual rights to the technology and inventions relating to A.G.E.s and other protein crosslinking, including those relating to the complications of aging and diabetes. See "--Patents, Trade Secrets and Licenses." The Picower Institute for Medical Research Pursuant to an agreement with The Picower Institute, a not-for-profit biomedical science institution, we have received an exclusive worldwide, royalty-bearing license for certain commercial health care applications of A.G.E.-related inventions. See "--Patents, Trade Secrets and Licenses." MANUFACTURING We have no manufacturing facilities for either production of bulk chemicals or the manufacturing of pharmaceutical dosage forms. We rely on third-party contract manufacturers to produce the raw materials and chemicals used as the active drug ingredients in our products used in clinical trials, and we expect to rely on third parties to perform the tasks necessary to process, package and distribute these products in finished form. We will inspect third-party contract manufacturers and their consultants to confirm compliance with current Good Manufacturing Practice ("cGMP") required for pharmaceutical products. We believe we will obtain sufficient quantities of bulk chemicals at reasonable prices to satisfy anticipated needs. There can be no assurance, however, that we can continue to meet our needs for supply of bulk chemicals or that manufacturing limitations will not delay clinical trials or possible commercialization. See "--Corporate Strategic Alliances." MARKETING AND SALES We plan to market and sell our products, if successfully developed and approved, directly or through co-promotion or other licensing arrangements with third parties. Such arrangements may be exclusive or nonexclusive and may provide for marketing rights worldwide or in a specific market. For certain of our products, we have licensed exclusive marketing rights, formed joint marketing arrangements or granted distribution rights within specified territories with its corporate partners, Yamanouchi, Roche, Gamida and IDEXX. See "--Corporate Strategic Alliances." 9 10 PATENTS, TRADE SECRETS AND LICENSES Proprietary protection for our product candidates, processes and know-how is important to our business. We aggressively file and prosecute patents covering our proprietary technology, and, if warranted, will defend our patents and proprietary technology. As appropriate, we seek patent protection for our proprietary technology and products in the United States and Canada and in key commercial European and Asia/Pacific countries. We also rely upon trade secrets, know-how, continuing technological innovation and licensing opportunities to develop and maintain our competitive position. As of December 31, 2000, our patent estate of owned and/or licensed patent rights consisted of 98 issued patents and one allowed United States patent application, none of which expire prior to 2005, and 30 pending patent applications in the United States, the majority of which are A.G.E.-related. We also own or have exclusive rights to over 80 issued patents in Europe, Japan, Australia and Canada. We have four issued United States patents and three issued foreign patents, including one from the European Patent Office, as well as 22 pending patent applications in the United States, covering certain novel compounds in the A.G.E. crosslink breaker category. These patents and additional patent applications contain compound, composition and method of treatment claims for several chemical classes of crosslink breaker compounds. Pimagedine is not protected by a composition-of-matter patent but is protected by a series of use patents. In 1992, a United States patent on the use of Pimagedine was issued to Rockefeller University and subsequently exclusively licensed to us with claims relating to the inhibition of A.G.E. formation. The patent claims the new use of a known agent for the treatment of the complications of aging and diabetes. In 1994, corresponding patents were granted in France, Germany, Italy, the United Kingdom and other European countries. A corresponding patent was issued in Japan in 1995. We continue to pursue and patent chemical analogs of known A.G.E.-formation inhibitors, as well as novel compounds having potential inhibitory properties. We believe that our licensed and owned patents provide a substantial proprietary base that will allow us and our collaborative partners to commercialize products in this field. There can be no assurance, however, that pending or future applications will issue, that the claims of any patents which do issue will provide any significant appreciation of our technology or that our directed discovery research will yield compounds and products of therapeutic and commercial value. In 1987, we acquired an exclusive, royalty-free, worldwide license (including the right to sub-license to others) to issued patents, patent applications and trade secrets from Rockefeller University relating to the A.G.E.-formation and crosslinking technology currently under development by us. Additional patent applications have since been filed on discoveries made in support of the technology from research conducted at Rockefeller University, The Picower Institute and our laboratories. Pursuant to our agreement with The Picower Institute, certain patentable inventions and discoveries relating to A.G.E. technology have been licensed exclusively to us. In consultation with us, The Picower Institute is responsible for the worldwide filing and prosecution of patent applications and maintenance of patents for such inventions. We will contribute 50% of the cost of such activities. We intend to continue to focus our research and development efforts on the synthesis of novel compounds and on the search for additional therapeutic applications to expand and broaden our rights within our technological and patent base. We are also prepared to in-license additional technology that may be useful in building our proprietary position. Where appropriate, we utilize trade secrets and unpatentable improvements to enhance our technology base and improve our competitive position. We require all employees, scientific consultants and contractors to execute confidentiality agreements as a condition of engagement. There can be no assurance, however, that we can limit unauthorized or wrongful disclosures of unpatented trade secret information. We believe that our estate of licensed and owned issued patents, if upheld, and pending applications, if granted and upheld, will be a substantial factor in our success. The patent positions of pharmaceutical firms, including ours, are generally uncertain and involve complex legal and factual questions. Consequently, even though we are currently prosecuting such patent applications in the United States and foreign patent offices, we do not know whether any of such applications will result in the issuance of any additional patents or, if any additional patents are 10 11 issued, whether the claims thereof will provide significant proprietary protection or will be circumvented or invalidated. Competitors or potential competitors have filed for or have received United States and foreign patents and may obtain additional patents and proprietary rights relating to compounds or processes competitive with those of ours. Accordingly, there can be no assurance that our patent applications will result in patents being issued or that, if issued, the claims of the patents will afford protection against competitors with similar technology; nor can there be any assurance that others will not obtain patents that we would need to license or circumvent. See "--Competition." Our success will depend, in part, on our ability to obtain patent protection for its products, preserve our trade secrets and operate without infringing on the proprietary rights of third parties. There can be no assurance that our current patent estate will enable us to prevent infringement by third parties or that competitors will not develop competitive products outside the protection that may be afforded by the claims of such patents. To the extent we rely on trade secrets and unpatented know-how to maintain our competitive technological position, there can be no assurance that others may not develop independently the same or similar technologies. Failure to maintain our current patent estate or to obtain requisite patent and trade secret protection, which may become material or necessary for product development, could delay or preclude us or our licensees or marketing partners from marketing their products and could thereby have a material adverse effect on our business, financial condition and results of operations. GOVERNMENT REGULATION We and our products are subject to comprehensive regulation by the FDA in the United States and by comparable authorities in other countries. These national agencies and other federal, state and local entities regulate, among other things, the pre-clinical and clinical testing, safety, effectiveness, approval, manufacturing, labeling, marketing, export, storage, record keeping, advertising and promotion of our products. The process required by the FDA before our products may be approved for marketing in the United States generally involves (i) pre-clinical new drug laboratory and animal tests, (ii) submission to the FDA of an IND, which must become effective before clinical trials may begin, (iii) adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug for its intended indication, (iv) submission to the FDA of a new drug application ("NDA") and (v) FDA review of the NDA in order to determine, among other things, whether the drug is safe and effective for its intended uses. There is no assurance that the FDA review process will result in product approval on a timely basis, if at all. Pre-clinical tests include laboratory evaluation of product chemistry and formulation, as well as animal studies to assess the potential safety and efficacy of the product. Certain pre-clinical tests are subject to FDA regulations regarding current Good Laboratory Practices. The results of the pre-clinical tests are submitted to the FDA as part of an IND and are reviewed by the FDA prior to the commencement of clinical trials or during the conduct of the clinical trials, as appropriate. Clinical trials are conducted under protocols that detail such matters as the objectives of the study, the parameters to be used to monitor safety and the efficacy criteria to be evaluated. Each protocol must be submitted to the FDA as part of the IND. Further, each protocol must be reviewed and approved by an institutional review board. Clinical trials are typically conducted in three sequential phases, which may overlap. During Phase I, when the drug is initially given to human subjects, the product is tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. Phase II involves studies in a limited patient population to (i) evaluate preliminarily the efficacy of the product for specific, targeted indications, (ii) determine dosage tolerance and optimal dosage and (iii) identify possible adverse effects and safety risks. Phase II/III trials are undertaken in order to further evaluate clinical efficacy and to further test for safety within an expanded patient population. The FDA may suspend clinical trials at any point in this process if it concludes that clinical subjects are being exposed to an unacceptable health risk. We will need FDA approval of our products, including a review of the manufacturing processes and facilities used to produce such products before such products may be marketed in the United States. The process of obtaining approvals from the FDA can be costly, time-consuming and subject to unanticipated delays. There can be no assurance that the FDA will grant approvals of our proposed products, processes or facilities on a timely basis, if 11 12 at all. Any delay or failure to obtain such approvals would have a material adverse effect on our business, financial condition and results of operations. Moreover, even if regulatory approval is granted, such approval may include significant limitations on indicated uses for which a product could be marketed. Among the conditions for NDA approval is the requirement that the prospective manufacturer's manufacturing procedures conform to cGMP requirements, which must be followed at all times. In complying with those requirements, manufacturers (including a drug sponsor's third-party contract manufacturers) must continue to expend time, money and effort in the area of production and quality control to ensure compliance. Domestic manufacturing establishments are subject to periodic inspections by the FDA in order to assess, among other things, cGMP compliance. To supply a product for use in the United States, foreign manufacturing establishments must comply with cGMP and are subject to periodic inspection by the FDA or by regulatory authorities in certain of such countries under reciprocal agreements with the FDA. Both before and after approval is obtained, a product, its manufacturer and the holder of the NDA for the product are subject to comprehensive regulatory oversight. Violations of regulatory requirements at any stage, including the pre-clinical and clinical testing process, the approval process, or thereafter (including after approval) may result in various adverse consequences, including the FDA's delay in approving or refusal to approve a product, withdrawal of an approved product from the market and/or the imposition of criminal penalties against the manufacturer and/or NDA holder. In addition, later discovery of previously unknown problems may result in restrictions on such product, manufacturer or NDA holder, including withdrawal of the product from the market. Also, new government requirements may be established that could delay or prevent regulatory approval of our products under development. The FDA has implemented accelerated approval procedures for certain pharmaceutical agents that treat serious or life-threatening diseases and conditions, especially where no satisfactory alternative therapy exists. We cannot predict the ultimate impact, however, of the FDA's accelerated approval of procedures on the timing or likelihood of approval of any of our potential products or those of any competitor. In addition, the approval of a product under the accelerated approval procedures may be subject to various conditions, including the requirement to verify clinical benefit in post-marketing studies, and the authority on the part of the FDA to withdraw approval under streamlined procedures if such studies do not verify clinical benefit. For marketing outside the United States, we will have to satisfy foreign regulatory requirements governing human clinical trials and marketing approval for drugs and diagnostic products. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary widely from country to country. We do not currently have any facilities or personnel outside of the United States. In addition to regulations enforced by the FDA, we are also subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other present and potential future federal, state or local regulations. Our research and development involves the controlled use of hazardous materials, chemicals and various radioactive compounds. Although we believe that our safety procedures for handling and disposing of such materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident, we could be held liable for any damages that result and any such liability could exceed our resources. COMPETITION We believe that A.G.E.s are a major factor contributing to many of the disorders of aging and diabetes, including cardiovascular, kidney and eye diseases. We are aware of several biotechnology companies that are developing A.G.E.-formation inhibitors. We have no knowledge of any company that has an A.G.E. crosslink breaker compound in clinical development. Many companies are pursuing research and development of compounds for cardiovascular and kidney diseases and the lowering of glucose levels. Many of our potential competitors have substantially greater financial, technical and human resources than ours and may be better equipped to develop, manufacture and market products. In addition, many of these companies have extensive experience in pre-clinical testing and human clinical trials. These companies may develop and introduce products and processes competitive with or superior to ours. 12 13 Our competition will be determined, in part, by the potential indications for which our compounds are developed and ultimately approved by regulatory authorities. For certain of our potential products, an important factor in competition may be the timing of market introduction of our or our competitors' products. Accordingly, the relative speed with which we can develop products, complete the clinical trials and approval processes and supply commercial quantities of the products to the market are important competitive factors. We expect that competition among products approved for sale will be based on, among other things, product efficacy, safety, reliability, availability, price and patent position. Our competitive position also depends upon our ability to attract and retain qualified personnel, obtain protection or otherwise develop proprietary products or processes and secure sufficient capital resources. A broad range of drugs is under development that could reduce or eliminate the market for any product developed by us. For example, competitive drugs based on other therapeutic mechanisms may be efficacious in treating cardiovascular disease or diabetic complications. The development by others of non-A.G.E.-related treatment modalities could render our products non-competitive or obsolete. Therapeutic approaches being pursued by others include curing cardiovascular disease or diabetic complications via gene therapy or cell transplantation, as well as pharmaceutical intervention with agents such as the aldose reductase inhibitors. Angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, beta-blockers and diuretics are effective treatments for essential hypertension, a disease characterized by increased peripheral vascular resistance (essential hypertension closely related to diastolic blood pressure). ISH, characterized by increased stiffness of the large arteries, is not usually associated with increased peripheral vascular resistance. In the absence of any marketed products that address the underlying pathology of ISH patients, treatments approved for essential hypertension are currently being prescribed to treat hypertension in these patients. However, these agents are of limited value where stiffness of the large arteries is the underlying pathology. Results of the DCCT showed that tight glucose control reduced the incidence of diabetic complications. Numerous companies are pursuing other methods to manage glucose control and to reduce the incidence of diabetic complications. In addition, several companies have initiated research with drugs that inhibit vascularization as a potential treatment of diabetic retinopathy. In the event one or more of these initiatives are successful, the market for some of our products may be reduced or eliminated. MEDICAL AND CLINICAL ADVISORS Our Medical and Clinical Advisors consist of individuals with recognized expertise in the medical and pharmaceutical science and related fields who advise us about present and long-term scientific planning, research and development. These advisors consult and meet with our management informally on a frequent basis. All advisors are employed by employers other than us and may have commitments to, or consulting or advisory agreements with, other entities that may limit their availability to us. These companies may also be competitors of ours. The advisors have agreed, however, not to provide any services to any other entities that might conflict with the activities that they provide us. Each member also has executed a confidentiality agreement for our benefit. The following persons are Medical and Clinical Advisors: George L. Bakris, M.D., F.A.C.P., F.C.P., Professor of Preventive and Internal Medicine, Vice Chairman, Department of Preventive Medicine and Director, Hypertension/Clinical Research Center, Rush-Presbyterian/St. Luke's Medical Center; President, American College of Clinical Pharmacology. Leslie Z. Benet, Ph.D., Professor UCSF, School of Pharmacy, Department of Biopharmaceutical Sciences; Chairman of the Board, AvMax, Inc.; former Chairman, Department of Biopharmaceutical Sciences of UCSF. Michael A. Brownlee, M.D., Anita and Jack Saltz Professor of Diabetes Research, Departments of Medicine and Pathology, Albert Einstein College of Medicine. Edward D. Frohlich, M.D., Distinguished Scientist of the Alton Ochsner Medical Foundation; Professor of Medicine and Physiology at Louisiana State University; Clinical Professor of Medicine and Adjunct Professor of Pharmacology at Tulane University; President, Society of Geriatrich Cardiology. 13 14 Richard J. Glassock, M.D., M.A.C.P., Professor Emeritus, UCLA School of Medicine; Past-President, National Kidney Foundation; Past-President, American Society of Nephrology. Jan Lessem, M.D., Ph.D., F.A.C.C., Chief Medical Officer and Vice President, Clinical Research and Development, OraPharma, Inc.; former Vice President and Corporate Officer, Drug Strategy and Medical Director, Takeda America, Inc.; former Director of Clinical Investigations, SmithKline Beecham Pharmaceuticals. Lawrence Resnick, M.D., Professor of Medicine, Division of Hypertension, New York Presbyterian Hospital/Weill Medical College of Cornell Medical Center. Mark E. Williams, M.D., Director of Dialysis, Joslin Diabetes Center; Chairman, National Scientific Council on Diabetic Kidney Disease, National Kidney Foundation. EMPLOYEES As of February 28, 2001, we employed 26 persons (eight of whom held a Ph.D., M.D. or other advanced degree), of whom 13 were engaged in research and development and 13 were engaged in administration and management. We believe that we have been successful in attracting skilled and experienced personnel. Our employees are not covered by collective bargaining agreements, but all employees are covered by confidentiality agreements. We believe that our relationship with our employees is good. FORWARD-LOOKING STATEMENTS AND CAUTIONARY STATEMENTS Statements in this Form 10-K that are not statements or descriptions of historical facts are "forward-looking" statements under Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 and are subject to numerous risks and uncertainties. These forward-looking statements and other forward-looking statements made by us or our representatives are based on a number of assumptions. The words "believe," "expect," "anticipate," "intend," "estimate" or other expressions, which are predictions of or indicate future events and trends and which do not relate to historical matters, identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements as they involve risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in this section and elsewhere in this Form 10-K. These factors include, but are not limited to, the risks set forth below. The forward-looking statements represent our judgment and expectations as of the date of this Report. We assume no obligation to update any such forward-looking statements. WE MAY NOT BE ABLE TO OBTAIN SUFFICIENT ADDITIONAL FUNDING TO MEET OUR NEEDS OR TO ALLOW US TO CONTINUE THE RESEARCH, PRODUCT DEVELOPMENT, PRE-CLINICAL TESTING AND CLINICAL TRIALS OF OUR PRODUCT CANDIDATES. We anticipate that our existing available cash and cash equivalents and short-term investments will be adequate to satisfy our working capital requirements for our current operations into 2002. We will require substantial new funding in order to continue the research, product development, pre-clinical testing and clinical trials of our product candidates, including ALT-711 and Pimagedine. We will also require additional funding for operating expenses, the pursuit of regulatory approvals for our product candidates and the establishment of marketing and sales capabilities. Our future capital requirements will depend on many factors, including continued scientific progress in our research and development programs, the size and complexity of these programs, progress with pre-clinical testing and clinical trials, the time and costs involved in obtaining regulatory approvals, the costs involved in filing, prosecuting and enforcing patent claims, competing technological and market developments, the establishment of additional collaborative arrangements, the cost of manufacturing arrangements, commercialization activities and the cost of product in-licensing and strategic acquisitions, if any. We cannot be certain that our cash reserves and other liquid assets will be adequate to satisfy our capital and operating requirements. We intend to seek funding through arrangements with corporate collaborators and through public or private sales of our securities, including equity securities, when and if conditions permit. In addition, we may pursue opportunities to obtain debt financing, including capital leases, in the future. We cannot be certain, however, that additional funding will be available on reasonable terms, if at all. Any additional equity financing would be dilutive to our stockholders. If adequate funds are not available, we may be required to curtail significantly or eliminate one or more of our research and development programs. If we obtain funds through arrangements with collaborative partners or others, we may be required to relinquish rights to certain of our technologies or product candidates. 14 15 WE MAY NOT SUCCESSFULLY DEVELOP OR DERIVE REVENUES FROM ANY PRODUCTS. All of our product candidates are in research or clinical development. We cannot be certain that we will succeed in the development and marketing of any therapeutic or diagnostic product. To achieve profitable operations, we must, alone or with others, successfully identify, develop, introduce and market proprietary products. Such products will require significant additional investment, development and pre-clinical and clinical testing prior to potential regulatory approval and commercialization. We have not yet requested or received regulatory approval for any product from the FDA or any other regulatory body. Before obtaining regulatory approvals for the commercial sale of any of our products under development, we must demonstrate through pre-clinical studies and clinical trials that the product is safe and effective for use in each target indication. The results from pre-clinical studies and early clinical trials may not be predictive of results that will be obtained in large-scale testing, and we cannot be certain that any clinical trials we undertake will demonstrate sufficient safety and efficacy to obtain the requisite regulatory approvals or will result in marketable products. The development of new pharmaceutical products is highly uncertain and subject to a number of significant risks. Potential products that appear to be promising at early stages of development may not reach the market for a number of reasons. Potential products may be found ineffective or cause harmful side effects during pre-clinical testing or clinical trials, fail to receive necessary regulatory approvals, be difficult to manufacture on a large scale, be uneconomical, fail to achieve market acceptance or be precluded from commercialization by proprietary rights of third parties. We cannot be certain that we will undertake additional clinical trials or that our product development efforts will be successfully completed, that required regulatory approvals can be obtained or that any products, if introduced, will be successfully marketed or achieve customer acceptance. We do not expect any of our products, including ALT-711 and Pimagedine, to be commercially available for a number of years, if at all. WE MAY NEVER GENERATE PROFITS. All of our revenues to date have been generated from collaborative research agreements and financing activities, or interest income earned on these funds. We have not received any revenues from product sales. We cannot be certain that we will realize product revenues on a timely basis, if at all. At December 31, 2000, we had an accumulated deficit of $134,011,000. We anticipate that we will incur substantial, potentially greater losses in the future. We cannot be certain that our products under development will be successfully developed or that our products, if successfully developed, will generate revenues sufficient to enable us to earn a profit. We expect to incur substantial additional operating expenses over the next several years as our research, development and clinical trial activities increase. We do not expect to generate revenues from the sale of products, if any, for a number of years. Our ability to achieve profitability depends, in part, on our ability to enter into agreements for product development, obtain regulatory approval for our products and develop the capacity or enter into agreements, for the manufacture, marketing and sale of any products. We cannot be certain that we will obtain required regulatory approvals, or successfully develop, manufacture, commercialize and market product candidates or that we will ever achieve product revenues or profitability. Based on the performance of our stock, we repriced certain employee stock options on February 2, 1999, in order to bolster employee retention. As a result of this repricing, options to purchase 1.06 million shares of stock were repriced and certain vesting periods related to these options were modified or extended. This repricing may have a material adverse impact on future financial performance based on an amendment to the Accounting Principals Board Opinion No. 25 ("APB Opinion No. 25"), "Accounting for Stock Issued to Employees." This amendment requires us to record compensation expense, which is adjusted every quarter, for increases or decreases in the fair market value of the repriced options based on changes in our stock price from the value at July 1, 2000, until the repriced options are exercised, forfeited or expire. WE MAY NOT BE ABLE TO FORM AND MAINTAIN THE COLLABORATIVE RELATIONSHIPS THAT OUR BUSINESS STRATEGY REQUIRES. Our strategy for developing and deriving revenues from our products depends, in large part, upon entering into arrangements with research collaborators, corporate partners and others. We have established collaborative arrangements with Yamanouchi, Gamida, Roche and IDEXX with respect to the development of drug therapies and diagnostics utilizing our scientific platforms. To succeed, we will have to 15 16 develop additional relationships. We are seeking to establish new collaborative relationships to provide the funding necessary for continuation of our product development, but we cannot be certain that such effort will be successful. If we are unable to enter into or manage additional collaborations, our programs may suffer and we may be unable to develop products. OUR DEPENDENCE ON COLLABORATIVE RELATIONSHIPS MAY LEAD TO DELAYS IN PRODUCT DEVELOPMENT AND DISPUTES OVER RIGHTS TO TECHNOLOGY. We will, in some cases, be dependent upon outside partners to conduct pre-clinical testing and clinical trials and to provide adequate funding for our development programs. Our corporate partners may have all or a significant portion of the development and regulatory approval responsibilities. Failure of the corporate partners to develop marketable products or to gain the appropriate regulatory approvals on a timely basis, if at all, would have a material adverse effect on our business, financial condition and results of operations. In most cases, we will not be able to control the amount and timing of resources that our corporate partners devote to our programs or potential products. If any of our corporate partners breached or terminated its agreements with us or otherwise failed to conduct its collaborative activities in a timely manner, the pre-clinical or clinical development or commercialization of product candidates or research programs could be delayed, and we would be required to devote additional resources to product development and commercialization or terminate certain development programs. We cannot be certain that disputes will not arise in the future with respect to the ownership of rights to any technology we develop with third parties. These and other possible disagreements between us and collaborators could lead to delays in the collaborative research, development or commercialization of product candidates or could require or result in litigation or arbitration, which would be time-consuming and expensive and would have a material adverse effect on our business, financial condition and results of operations. Any corporate partners we have may develop, either alone or with others, products that compete with the development and marketing of our products. Competing products, either developed by the corporate partners or to which the corporate partners have rights, may result in their withdrawal of support with respect to all or a portion of our technology, which would have a material adverse effect on our business, financial condition and results of operations. WE MAY NOT BE ABLE TO PROTECT THE PROPRIETARY RIGHTS THAT ARE CRITICAL TO OUR SUCCESS. Our success will depend on our ability to obtain patent protection for our products, preserve our trade secrets, prevent third parties from infringing upon our proprietary rights and operate without infringing upon the proprietary rights of others, both in the United States and abroad. We cannot be certain that competitors will not develop competitive products outside the protection that may be afforded by the claims of our patents. We are aware that other parties have been issued patents and have filed patent applications in the United States and foreign countries with respect to other agents which impact A.G.E. or A.G.E. crosslink formation. The degree of patent protection afforded to pharmaceutical inventions is uncertain and our potential products are subject to this uncertainty. Pimagedine is not a novel compound and is not covered by a composition-of-matter patent. The patents covering Pimagedine are use patents containing claims covering therapeutic indications and the use of Pimagedine to inhibit A.G.E. formation. Competitors may develop and commercialize Pimagedine or Pimagedine-like products for indications outside of the protection provided by the claims of our use patents. Physicians, pharmacies and wholesalers could then substitute for our Pimagedine products. Substitution for our Pimagedine products would have a material adverse effect on our business, financial condition and results of operations. Use patents may afford a lesser degree of protection in certain foreign countries due to their patent laws. In addition, although we have several patent applications pending to protect proprietary technology and potential products, we cannot be certain that these patents will be issued, that the claims of any patents which do issue will provide any significant protection of our technology or products, or that we will enjoy any patent protection beyond the expiration dates of our currently issued patents. We also rely upon unpatented trade secrets and improvements, unpatented know-how and continuing technological innovation to maintain, develop and expand our competitive position, which we seek to protect, in 16 17 part, by confidentiality agreements with our corporate partners, collaborators, employees and consultants. We also have invention or patent assignment agreements with our employees and certain, but not all, corporate partners and consultants. We cannot be certain that relevant inventions will not be developed by a person not bound by an invention assignment agreement. We cannot be certain that binding agreements will not be breached, that we would have adequate remedies for such breach, or that our trade secrets will not otherwise become known to or be independently discovered by competitors. WE CANNOT BE CERTAIN THAT REGULATORY APPROVALS WILL BE OBTAINED FOR OUR PRODUCTS. Our research, pre-clinical testing and clinical trials of our product candidates are, and the manufacturing and marketing of our products will be, subject to extensive and rigorous regulation by numerous governmental authorities in the United States and in other countries where we intend to test and market our product candidates. Prior to marketing, any product we develop must undergo an extensive regulatory approval process. This regulatory process, which includes pre-clinical testing and clinical trials, and may include post-marketing surveillance, of each compound to establish its safety and efficacy, can take many years and can require the expenditure of substantial resources. Data obtained from pre-clinical and clinical activities is susceptible to varying interpretations that could delay, limit or prevent regulatory approval. In addition, we may encounter delays or rejections based upon changes in FDA policy for drug approval during the period of product development and FDA regulatory review of each submitted NDA. We may encounter similar delays in foreign countries. We cannot be certain that regulatory approval will be obtained for any drugs we develop. Moreover, regulatory approval may entail limitations on the indicated uses of the drug. Further, even if regulatory approval is obtained, a marketed drug and its manufacturer are subject to continuing review and discovery of previously unknown problems with a product or manufacturer which may have adverse effects on our business, financial condition and results of operations, including withdrawal of the product from the market. Violations of regulatory requirements at any stage, including pre-clinical testing and clinical trials, the approval process or post-approval, may result in various adverse consequences including the FDA's delay in approving, or its refusal to approve, a product withdrawal of an approved product from the market and the imposition of criminal penalties against the manufacturer and NDA holder. None of our products has been approved for commercialization in the United States or elsewhere. We cannot be certain that we will be able to obtain FDA approval for any products. Failure to obtain requisite governmental approvals or failure to obtain approvals of the scope requested will delay or preclude our licensees or marketing partners from marketing our products or limit the commercial use of such products and will have a material adverse effect on our business, financial condition and results of operations. WE MAY NOT BE ABLE TO COMPETE SUCCESSFULLY WITH BIOTECHNOLOGY COMPANIES AND ESTABLISHED PHARMACEUTICAL COMPANIES IN THE DEVELOPMENT AND MARKETING OF CURES AND THERAPIES FOR DIABETES, CARDIOVASCULAR DISEASES AND THE OTHER CONDITIONS FOR WHICH WE SEEK TO DEVELOP PRODUCTS. We are engaged in pharmaceutical fields characterized by extensive research efforts and rapid technological progress. Many established pharmaceutical and biotechnology companies with resources greater than ours are attempting to develop products that would be competitive with our products. Other companies may succeed in developing products that are safer, more efficacious or less costly than any we may develop and may also be more successful than us in production and marketing. Rapid technological development by others may result in our products becoming obsolete before we recover a significant portion of the research, development or commercialization expenses incurred with respect to those products. Certain technologies under development by other pharmaceutical companies could result in a cure for diabetes or the reduction of the incidence of diabetes and its complications. For example, a number of companies are investigating islet cell transplantation as a possible cure for Type 1 diabetes. Results of a study conducted by the National Institutes of Health, known as the DCCT, published in 1993, showed that tight glucose control reduced the incidence of diabetic complications. Several pharmaceutical companies have introduced new products for glucose control for the management of hyperglycemia in Type 2 diabetes. In addition, several large companies have initiated or expanded research, development and licensing efforts to build a diabetic pharmaceutical franchise focusing on diabetic nephropathy, neuropathy, retinopathy and related conditions. An example of this is research seeking anti-angiogenesis drugs for the potential treatment of diabetic retinopathy. It is possible that one or more of these initiatives may reduce or eliminate the market for some of our products. 17 18 In addition, a broad range of cardiovascular drugs are under development by many pharmaceutical and biotechnology companies. It is possible that one or more of these initiatives may reduce or eliminate the market for some of our products. EFFORTS TO REDUCE HEALTH CARE COSTS MAY AFFECT OUR OPERATIONS. Our business, financial condition and results of operations may be materially adversely affected by the continuing efforts of government and third-party payers to contain or reduce the costs of health care through various means. For example, in certain foreign markets, pricing and/or profitability of prescription pharmaceuticals are subject to government control. In the United States, we expect that there will continue to be federal and state initiatives to control and/or reduce pharmaceutical expenditures. In addition, increasing emphasis on managed care in the United States will continue to put pressure on pharmaceutical pricing. Cost control initiatives could decrease the price that we receive for any products we may develop and sell in the future and have a material adverse effect on our business, financial condition and results of operations. Further, to the extent that cost control initiatives have a material adverse effect on our corporate partners, our ability to commercialize our products may be adversely affected. Our ability to commercialize pharmaceutical products may depend, in part, on the extent to which reimbursement for the products will be available from government health administration authorities, private health insurers and other third-party payers. Significant uncertainty exists as to the reimbursement status of newly approved health care products, and third-party payers, including Medicare, are increasingly challenging the prices charged for medical products and services. We cannot be certain that any third-party insurance coverage will be available to patients for any products developed by us. Government and other third-party payers are increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement for new therapeutic products and by refusing in some cases to provide coverage for uses of approved products for disease indications for which the FDA has not granted labeling approval. If adequate coverage and reimbursement levels are not provided by government and other third-party payers for our products, the market acceptance of these products would be adversely affected. WE HAVE NO EXPERIENCE IN MARKETING OR SALES AND MAY HAVE TO RELY ON OTHERS TO MARKET AND SELL ANY PRODUCTS WE MAY DEVELOP, WHICH MAY IMPAIR OUR ABILITY TO DELIVER PRODUCTS. For certain of our products, we have licensed exclusive marketing rights to our corporate partners or formed collaborative marketing arrangements within specified territories in return for royalties to be received on sales, a share of profits or beneficial transfer pricing. These agreements are terminable at the discretion of our partners upon as little as 90 days' prior written notice. If the licensee or marketing partner terminates an agreement or fails to market a product successfully, our business, financial condition and results of operations may be adversely affected. We currently have no experience in marketing or selling pharmaceutical products. In order to achieve commercial success for any approved product, we must either develop a marketing and sales force or, where appropriate or permissible, enter into arrangements with third parties to market and sell our products. We cannot be certain that we will develop successfully marketing and sales experience, or that we will be able to enter into marketing and sales agreements with others on acceptable terms, if at all, or that any such arrangements, if entered into, will not be terminated. If we develop our own marketing and sales capability, it will compete with other companies that currently have experienced, well funded and larger marketing and sales operations. To the extent that we enter into co-promotion or other sales and marketing arrangements with other companies, revenues will depend on the efforts of others, and we cannot be certain that their efforts will be successful. WE HAVE NO EXPERIENCE IN MANUFACTURING PRODUCTS AND MAY HAVE TO RELY ON OTHERS TO MANUFACTURE ANY PRODUCTS WE MAY DEVELOP, WHICH MAY IMPAIR OUR ABILITY TO DEVELOP OR DELIVER PRODUCTS. We have no experience in manufacturing products for commercial purposes and do not have manufacturing facilities. Consequently, we are dependent on contract manufacturers for the production of products for development and commercial purposes. The manufacture of our products for clinical trials and commercial purposes is subject to cGMP regulations promulgated by the FDA. In the event that we are unable to obtain or retain third-party manufacturing for our products, we will not be able to commercialize such products as planned. We cannot be certain that we will be able to enter into agreements for the manufacture of future products with manufacturers whose facilities and procedures comply with cGMP and other regulatory requirements. Our current 18 19 dependence upon others for the manufacture of our products may adversely affect our profit margin, if any, on the sale of future products and our ability to develop and deliver such products on a timely and competitive basis. USE OF ANY PRODUCTS WE DEVELOP MAY RESULT IN LIABILITY CLAIMS. The use of any of our potential products in clinical trials and the sale of any approved products, including the testing and commercialization of ALT-711 or Pimagedine, may expose us to liability claims resulting from the use of products or product candidates. These claims might be made directly by consumers, pharmaceutical companies or others. We maintain product liability insurance coverage for claims arising from the use of our products in clinical trials. However, coverage is becoming increasingly expensive, and we cannot be certain that we will be able to maintain insurance or, if maintained, that insurance can be acquired at a reasonable cost or in sufficient amounts to protect us against losses due to liability that could have a material adverse effect on our business, financial conditions and results of operations. We cannot be certain that we will be able to obtain commercially reasonable product liability insurance for any product approved for marketing in the future or that insurance coverage and our resources would be sufficient to satisfy any liability resulting from product liability claims. A successful product liability claim or series of claims brought against us could have a material adverse effect on our business, financial condition and results of operations. WE MAY BE UNABLE TO ATTRACT AND RETAIN THE KEY PERSONNEL ON WHOM OUR SUCCESS DEPENDS. We are highly dependent on the principal members of our management and scientific staff. The loss of services of any of these personnel could impede the achievement of our development objectives. Furthermore, recruiting and retaining qualified scientific personnel to perform research and development work in the future will also be critical to our success. We cannot be certain that we will be able to attract and retain personnel on acceptable terms given the competition between pharmaceutical and health care companies, universities and non-profit research institutions for experienced scientists. In addition, we rely on consultants to assist us in formulating our research and development strategy. All of our consultants are employed outside of us and may have commitments to or consulting or advisory contracts with other entities that may limit their availability to us. OUR OPERATIONS INVOLVE A RISK OF INJURY OR DAMAGE FROM HAZARDOUS MATERIALS. Our research and development activities involve the controlled use of hazardous materials, chemicals and various radioactive compounds. Although we believe that our safety procedures for handling and disposing of hazardous materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of an accident, we could be held liable for any damages or fines that result. Such liability could have a material adverse effect on our business, financial condition and results of operations. ITEM 2. PROPERTIES. We lease a 37,000 square foot building in Ramsey, New Jersey, which contains our executive and administrative offices and research laboratory space. The lease, which commenced on November 1, 1993, has a 10-year term. In addition, the lease has two five-year renewal options. ITEM 3. LEGAL PROCEEDINGS. On July 13, 2000 and August 8, 2000, Colby S. Parks and Marion H. Parks filed suits against us in the United States District Court for the Middle District of North Carolina and the Superior Court of Chatham County, North Carolina, respectively, claiming unspecified damages for injuries Mr. Parks allegedly sustained as a result of his participation in one of our Pimagedine clinical trials. Our liability insurance carrier is defending these actions. On October 20, 2000, Charles L. Grimes, one of our stockholders, and his wife, Jane Gillespie Grimes, filed a complaint against us in the Court of Chancery in Delaware, claiming breach of an alleged oral agreement with us which would have purportedly entitled Mr. Grimes to purchase 10% of our private placement of $6,235,000 of common stock and warrants in September 2000. We believe the suit is without merit and intend to defend it vigorously. 19 20 ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS. Not applicable. PART II ITEM 5. MARKET FOR THE COMPANY'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS. In our quarterly report on Form 10-Q for the quarter ended September 30, 2000, we reported that in September 2000, we had entered into an agreement to sell 2,834,088 shares of common stock (the "Shares") and warrants to purchase 1,133,636 shares of common stock (the "Warrants") to the parties named therein in a private placement. We indicated that the closing of the sale of one-half of the Shares and Warrants was completed on September 29, 2000, and that there would be a subsequent closing of the sale of the remainder of the Shares and Warrants. This subsequent closing of the remaining one-half of the Shares and Warrants was completed on November 28, 2000. Our Common Stock traded on the American Stock Exchange ("Amex") since August 7, 2000, under the symbol "ALT." Prior to August 7, 2000, our Common Stock was traded on the Over-the-Counter Bulletin Board ("OTCBB") under the symbol "ALTN." The following table sets forth, for the calendar periods indicated, the range of high and low sale prices for our Common Stock on Amex or OTCBB, as applicable:
2000 High Low ---- -------- -------- First Quarter.................... $ 5.0000 $ 0.9062 Second Quarter................... 3.6250 1.5000 Third Quarter.................... 3.5625 2.1250 Fourth Quarter................... 8.3125 2.8750
1999 High Low ---- -------- -------- First Quarter.................... $ 1.6875 $ 0.6875 Second Quarter................... 1.0625 0.6250 Third Quarter.................... 1.4375 0.5625 Fourth Quarter................... 1.3438 0.5000
As of February 28, 2001, there were 318 holders of the Common Stock. On February 28, 2001, the last sale price reported on the Amex for the Common Stock was $4.35 per share. We have neither paid nor declared dividends on our Common Stock since our inception and do not plan to pay dividends in the foreseeable future. Any earnings that we may realize will be returned to finance our growth. The market prices for securities of biotechnology and pharmaceutical companies, including ours, have historically been highly volatile, and the market has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. Factors, such as fluctuations in our operating results, announcements of technological innovations or new therapeutic products by us or others, clinical trial results, developments concerning agreements with collaborators, governmental regulation, developments in patent or other proprietary rights, public concern as to safety of drugs developed by us or others, future sales of substantial amounts of Common Stock by existing stockholders and general market conditions, can have an adverse effect on the market price of the Common Stock. 20 21 ITEM 6. SELECTED FINANCIAL DATA. The selected financial data set forth below should be read in conjunction with the audited financial statements and related notes included elsewhere in this Annual Report on Form 10-K. The selected financial data for the five years ended December 31, 2000, has been derived from our audited financial statements.
Years Ended December 31, ------------------------------------------------------------------------- 2000 1999 1998 1997 1996 --------- --------- --------- --------- --------- (in thousands, except per share data) STATEMENT OF OPERATIONS DATA: Revenues: Investment income ........................ $ 570 $ 835 $ 1,321 $ 1,510 $ 2,295 Other income ............................. -- 600 -- -- -- --------- --------- --------- --------- --------- Total revenues ....................... 570 1,435 1,321 1,510 2,295 Expenses: Research and development ................. 6,022 10,598 24,592 23,264 17,494 Elimination of previously accrued loss contingency ..................... -- -- (1,771) -- -- General and administrative ............... 4,422 4,357 4,842 3,633 3,517 Non-cash stock compensation .............. 1,244 -- -- -- -- Interest ................................. -- -- 4 25 47 --------- --------- --------- --------- --------- Total expenses ....................... 11,688 14,955 27,667 26,992 21,058 --------- --------- --------- --------- --------- Loss before income tax benefit ................ (11,118) (13,520) (26,346) (25,412) (18,763) Income tax benefit ............................ 1,548 2,588 -- -- -- --------- --------- --------- --------- --------- Net loss ...................................... (9,570) (10,932) (26,346) (25,412) (18,763) Preferred stock dividends and discount amortization ................ 2,945 2,707 2,207 1,091 -- --------- --------- --------- --------- --------- Net loss applicable to common stockholders .............................. $ (12,515) $ (13,639) $ (28,553) $ (26,503) $ (18,763) ========= ========= ========= ========= ========= Basic and diluted loss per share to common stockholders ....................... $ (0.63) $ (0.72) $ (1.57) $ (1.60) $ (1.20) ========= ========= ========= ========= ========= Weighted average common shares used in computing basic and diluted loss per share 19,861 19,055 18,211 16,566 15,640 ========= ========= ========= ========= ========= BALANCE SHEET DATA: Cash, cash equivalents and short-term investments ................... $ 9,955 $ 12,370 $ 24,132 $ 28,974 $ 34,500 Working capital ............................... 9,754 10,425 20,093 22,390 26,542 Total assets .................................. 13,389 15,021 27,652 33,508 40,139 Long-term capital lease obligations ........... -- -- -- -- 162 Accumulated deficit ........................... (134,011) (121,496) (107,857) (79,303) (52,800) Stockholders' equity .......................... 11,453 12,827 23,338 26,455 31,371
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. OVERVIEW We are a product-based biopharmaceutical company engaged in the discovery and development of oral drugs for the treatment of diseases of aging and diabetes. Our product candidates represent novel approaches to some of the largest pharmaceutical markets, such as cardiovascular and kidney diseases. Two of our compounds are in clinical development; several others are undergoing pre-clinical testing. These pharmaceutical candidates were developed as a result of our understanding of the Advanced Glycosylation End-product ("A.G.E.") pathway, a fundamental pathological process and inevitable consequence of aging that may result in many medical disorders. Our lead compound, ALT-711, is initially being developed for cardiovascular indications, including ISH. We recently completed a Phase IIa trial to evaluate the effect of ALT-711 on cardiovascular compliance. Based on the positive results of this trial, we plan to initiate a Phase IIb efficacy trial of ALT-711. We are pursuing development of other compounds from our library of A.G.E. crosslink breakers and A.G.E.-formation inhibitors in additional aging- and diabetes-related pathologies. 21 22 As we continue clinical development of ALT-711, we will determine if it is appropriate to retain development and marketing rights for one or several indications in North America, while at the same time continuing to evaluate potential corporate partnerships for the further development and ultimate marketing of the compound in other territories throughout the world. Since our inception in October 1986, we have devoted substantially all of our resources to research, drug discovery and development programs. To date, we have not generated any revenues from the sale of products and do not expect to generate any such revenues for a number of years, if at all. We have incurred an accumulated deficit of $134,011,000 as of December 31, 2000, and expect to incur operating losses, potentially greater than losses in prior years, for a number of years. We have financed our operations through proceeds from an initial public offering of Common Stock in 1991, a follow-on offering of Common Stock completed in 1995, and private placements of common and preferred equity securities, revenue from present and former collaborative relationships, reimbursement of certain of our research and development expenses by our collaborative partners, investment income earned on cash balances and short-term investments and the sale of a portion of our New Jersey State Net Operating Losses carryforwards. In September 2000, we entered into an agreement with several investors pursuant to which we sold them, in a private placement, an aggregate of 2,834,088 shares of common stock and warrants to purchase 1,133,636 shares of common stock (the "Warrants") for an aggregate purchase price of $6,235,000. The exercise price of the Warrants is $3.40 per share, while the term is seven years. In March 2000, the Financial Accounting Standards Board ("FASB") released Interpretation No. 44, "Accounting for Certain Transactions Involving Stock Compensation, An Interpretation of APB Opinion No. 25." The interpretation became effective on July 1, 2000, but in some circumstances applies to transactions that occur prior to the effective date. Under the interpretation, stock options that are repriced must be accounted for as variable-plan arrangements until the options are exercised, forfeited or expire. This requirement applies to any options repriced after December 15, 1998. On February 2, 1999, we repriced certain stock options. The total compensation expense resulting from the repricing and included in net loss for the year ended December 31, 2000, is $1,244,000. In 2000 and 1999, we sold $14.1 million and $27.6 million, respectively, of our gross State net operating loss carryforwards and $590,000 and $645,000, respectively, of our State research and development tax credit carryforwards under the State of New Jersey's Technology Business Tax Certificate Transfer Program (the "Program"). The Program allowed qualified technology and biotechnology business in New Jersey to sell unused amounts of net operating loss carryforwards and defined research and development tax credits for cash. The proceeds from the sale in 2000 and 1999 were $1,548,000 and $2,588,000, respectively, and such amounts were recorded as a tax benefit in the statements of operations. The proceeds from the sale of the net operating loss carryforwards and the research and development tax credit carryforwards sold in 2000 were received on January 8, 2001. Our business is subject to significant risks including, but not limited to, (i) our ability to obtain funding, (ii) the risks inherent in our research and development efforts, including clinical trials, (iii) uncertainties associated with obtaining and enforcing our patents and with the patent rights of others, (iv) the lengthy, expensive and uncertain process of seeking regulatory approvals, (v) uncertainties regarding government reforms and product pricing and reimbursement levels, (vi) technological change and competition, (vii) manufacturing uncertainties and (viii) dependence on collaborative partners and other third parties. Even if our product candidates appear promising at an early stage of development, they may not reach the market for numerous reasons. Such reasons include the possibilities that the products will prove ineffective or unsafe during clinical trials, will fail to receive necessary regulatory approvals, will be difficult to manufacture on a large scale, will be uneconomical to market or will be precluded from commercialization by proprietary rights of third parties. These risks and others are discussed under the heading "Forward-Looking Statements and Cautionary Statements." 22 23 RESULTS OF OPERATIONS Years Ended December 2000, 1999, 1998 Revenues Total revenues for 2000, 1999 and 1998 were $570,000, $1,435,000 and $1,321,000, respectively. Revenues were derived from interest earned on cash and cash equivalents and short-term investments, and in 1999, the $600,000 payment under an option agreement with Taisho Pharmaceutical Co., Ltd., pursuant to which they were granted an option by us (which expired without being exercised) to acquire a license to ALT-711 in certain territories. The decrease in revenues in 2000 over 1999 was attributed to a decrease in cash and cash equivalents and short-term investment balances and the absence of the option payment in 2000. Operating Expenses Total expenses decreased to $11,688,000 in 2000, from $14,955,000 in 1999 and $27,667,000 in 1998, and consisted primarily of research and development expenses. Research and development expenses were $6,022,000 in 2000, $10,598,000 in 1999 and $24,592,000 in 1998. Research and development expenses decreased in 2000, from 1999, by $4,576,000, or 43.2%. This decrease was primarily related to the closure of the ACTION I and ESRD trials and decreased personnel-related expenses, offset by increased expenses related to the ALT-711 Phase IIa costs. Research and development expenses decreased in 1999, from 1998, by $13,994,000, or 56.9%, due to the decreased expenses related to the closure of the ACTION I and ESRD trials and personnel-related expenses. General and administrative expenses were $4,422,000 in 2000, relatively unchanged from $4,357,000 in 1999 and $4,842,000 in 1998. In January 2000, and March 2000, we completed a downsizing of our associates. We undertook the downsizing to reduce operating expenses in order to preserve our existing capital resources for research and development programs. Non-cash stock compensation expense totaled $1,244,000 in 2000, which resulted from certain stock options being repriced. Net Loss At December 31, 2000, we had available Federal net operating loss carryforwards, which expire in various amounts from the years 2006 through 2020, of approximately $125.9 million for income tax purposes and State net operating loss carryforwards, which expire in the years 2001 through 2007, of approximately $81.8 million. In addition, we had Federal research and development credit carryforwards of approximately $4.9 million and State research and development tax credit carryforwards of approximately $2.2 million. We had net losses of $9,570,000 in 2000, $10,932,000 in 1999 and $26,346,000 in 1998. LIQUIDITY AND CAPITAL RESOURCES We had cash, cash equivalents and short-term investments at December 31, 2000, of $9,955,000 compared to $12,370,000 at December 31, 1999. This is a decrease in cash, cash equivalents and short-term investments for the twelve months ended December 31, 2000, of $2,415,000. This consisted of $8,986,000 of cash used in operations, consisting primarily of research and development expenses, personnel and related costs and facility expenses and approximately $62,000 of capital expenditures. This was offset by $6,636,000 of financing activities related to a private placement of common stock and proceeds from stock option exercises. As of December 31, 2000, we had invested $7,444,000 in capital equipment and leasehold improvements. In September 2000, we entered into an agreement with several investors pursuant to which we sold them, in a private placement, an aggregate of 2,834,088 shares of common stock and warrants to purchase 1,133,636 shares of common stock (the "Warrants") for an aggregate purchase price of $6,235,000. The exercise price of the Warrants is $3.40 per share, while the term is seven years. In 2000 and 1999, we sold $14.1 million and $27.6 million, respectively, of our gross State net operating loss carryforwards and $590,000 and $645,000, respectively, of our State research and development tax credit carryforwards under the Program. The Program allowed qualified technology and biotechnology business in New 23 24 Jersey to sell unused amounts of net operating loss carryforwards and defined research and development tax credits for cash. The proceeds in 2000 and 1999 were $1,548,000 and $2,588,000, respectively, and such amounts were recorded as a tax benefit in the statements of operations. The proceeds from the sale of the net operating loss carryforwards and the research and development tax credit carryforwards sold in 2000 were received on January 8, 2001. We anticipate that our existing available cash and cash equivalents and short-term investments will be adequate to satisfy our working capital requirements for our current operations into 2002. The amount of our future capital requirements will depend on numerous factors, including the progress of our research and development programs, the conduct of pre-clinical tests and clinical trials, the development of regulatory submissions, the costs associated with protecting patents and other proprietary rights, the development of marketing and sales capabilities and the availability of third-party funding. Because of our long-term capital requirements, we may seek access to the public or private equity markets whenever conditions are favorable. We may also seek additional funding through corporate collaborations and other financing vehicles, potentially including off-balance sheet financing through limited partnerships or corporations. There can be no assurance that such funding will be available at all or on terms acceptable to us. If adequate funds are not available, we may be required to curtail significantly one or more of our research or development programs. If we obtain funds through arrangements with collaborative partners or others, we may be required to relinquish rights to certain of our technologies or product candidates. Our current priorities are the evaluation and possible continued development of ALT-711, our lead A.G.E. Crosslink Breaker candidate, and the continued development of Pimagedine. We are focusing our resources on the development of ALT-711. As we continue clinical development of ALT-711, we will determine if it is appropriate to retain development and marketing rights for one or several indications in North America, while at the same time, continuing to evaluate potential corporate partnerships for the further development and ultimate marketing of the compound throughout the world. We have also decided to pursue the continued development of Pimagedine and are actively seeking one or more corporate partners. We believe that additional development of this compound and other product candidates will require us to find sources of funding. Effective August 7, 2000, our Common Stock was approved for listing on the American Stock Exchange under the symbol "ALT." In December 1999, the Securities and Exchange Commission ("SEC") issued Staff Accounting Bulletin No. 101 ("SAB 101"), "Revenue Recognition in Financial Statements." SAB 101 summarizes certain of the SEC's views in applying generally accepted accounting principles to revenue recognition in financial statements. The adoption of SAB 101 had no impact on the accompanying financial statements. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK. Our exposure to market risk for changes in interest rates relates primarily to our investment in marketable securities. We do not use derivative financial instruments in our investments. Our investments consist primarily of debt instruments of the U.S. government, government agencies, financial institutions and corporations with strong credit ratings. The table below presents principal amounts and related weighted average interest rates expected by maturity date for our investment portfolio. There are no maturities after 2001, and our exposure is limited based on the short-term nature of these investments.
2001 ---- Assets Cash equivalents: Fixed rate ............ $3,600,328 Average interest rate .. 6.72% Short-term investments: Fixed rate ............. $6,354,479 Average interest rate .. 6.64% Total investment securities: $9,954,807 Average interest rate .. 6.66%
24 25 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. a) The financial statements required to be filed pursuant to this Item 8 are appended to this Annual Report on Form 10-K. A list of the financial statements filed herewith is found at "Index to Financial Statements and Schedules" on page 28. b) The unaudited quarterly financial data for the two-year period ended December 31, 2000 is as follows:
Net Loss Loss Before Applicable to Income Tax Common Basic/Diluted Revenues Expenses Benefit Stockholders Loss Per Share -------- -------- --------- ------------ -------------- (in thousands, except per share amounts) 2000 First Quarter $ 166 $ 2,762 $ (2,596) $ (3,305) $ (0.17) Second Quarter 143 2,402 (2,259) (2,983) (0.15) Third Quarter 110 3,339 (3,229) (3,977) (0.20) Fourth Quarter 151 3,185 (3,034) (2,250) (0.11) -------- -------- -------- -------- -------- Total Year $ 570 $ 11,688 $(11,118) $(12,515) $ (0.63) 1999 First Quarter $ 278 $ 5,623 $ (5,345) $ (5,992) $ (0.32) Second Quarter 227 4,240 (4,013) (4,681) (0.25) Third Quarter 370 2,489 (2,119) (2,808) (0.15) Fourth Quarter 560 2,602 (2,043) (158) (0.00) -------- -------- -------- -------- -------- Total Year $ 1,435 $ 14,954 $(13,520) $(13,639) $ (0.72)
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE. Not applicable. PART III ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE COMPANY. The information called for by Item 10 is incorporated by reference from the information under the caption "Election of Directors," "Executive Officers" and "Section 16(a) Beneficial Ownership Reporting Compliance" in our Proxy Statement for our 2001 Annual Meeting of Stockholders to be held on June 5, 2001. ITEM 11. EXECUTIVE COMPENSATION. The information called for by Item 11 is incorporated by reference from the information under the caption "Executive Compensation" in our Proxy Statement for our 2001 Annual Meeting of Stockholders to be held on June 5, 2001. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT. The information called for by Item 12 is incorporated by reference from the information under the caption "Security Ownership of Certain Beneficial Owners and Management" in our Proxy Statement for our 2001 Annual Meeting of Stockholders to be held on June 5, 2001. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS. Not applicable. 25 26 PART IV ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K. (a) Financial Statements: Our audited financial statements, financial statement schedules and the Report of Independent Public Accountants are appended to this Annual Report on Form 10-K. Reference is made to the "Index to Financial Statements and Schedules" on page 28. (b) Reports on Form 8-K. On December 14, 2000, we filed a current report on Form 8-K, dated December 6, 2000, announcing the appointment of a Medical Director. On November 8, 2000, we filed a current report on Form 8-K, dated October 17, 2000, regarding the grant of a patent. On October 20, 2000, we filed a current report on Form 8-K, dated October 10, 2000, announcing that we entered into an agreement with HemoMax, LLC. On October 5, 2000, we filed a current report on Form 8-K, dated September 29, 2000, announcing that we entered into an agreement for the private placement of common stock and warrants. (c) Exhibits. The exhibits required to be filed are listed on the Index to Exhibits attached hereto, which is incorporated herein by reference. 26 27 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized this 1st day of March 2001. ALTEON INC. By: /s/ Kenneth I. Moch ------------------------------------------ Kenneth I. Moch President and Chief Executive Officer Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
Signature Title Date - --------- ----- ---- /s/ Mark Novitch Chairman of the Board March 1, 2001 - ---------------- Mark Novitch /s/ Kenneth I. Moch President and Chief Executive Officer March 1, 2001 - ------------------- (principal executive officer) Kenneth I. Moch /s/ Elizabeth O'Dell Vice President, Finance and Administration, March 1, 2001 - -------------------- Secretary and Treasurer (principal finance Elizabeth O'Dell and accounting officer) /s/ Edwin Bransome, Jr. M.D. Director March 1, 2001 - ---------------------------- Edwin Bransome, Jr. M.D. /s/ Marilyn G. Breslow Director March 1, 2001 - ---------------------- Marilyn G. Breslow /s/ Alan J. Dalby Director March 1, 2001 - ----------------- Alan J. Dalby /s/ David McCurdy Director March 1, 2001 - ----------------- David McCurdy /s/ George M. Naimark, Ph.D. Director March 1, 2001 - ---------------------------- George M. Naimark, Ph.D.
27 28 Form 10-K - Item 14(a)(1) Alteon Inc. Index to Financial Statements and Schedules
Page ---- Report of Independent Public Accountants - Arthur Andersen LLP ......... 29 Financial Statements: Balance Sheets at December 31, 2000 and 1999 ................... 30 Statements of Operations for the years ended December 31, 2000, 1999 and 1998 .......................... 31 Statements of Stockholders' Equity for the years ended December 31, 2000, 1999 and 1998 .......................... 32 Statements of Cash Flows for the years ended December 31, 2000, 1999 and 1998 .......................... 33 Notes to Financial Statements .................................. 34
28 29 REPORT OF INDEPENDENT PUBLIC ACCOUNTANTS To Alteon Inc.: We have audited the accompanying balance sheets of Alteon Inc. (a Delaware corporation) as of December 31, 2000 and 1999, and the related statements of operations, stockholders' equity and cash flows for each of the three years in the period ended December 31, 2000. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Alteon Inc. as of December 31, 2000 and 1999, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2000, in conformity with accounting principles generally accepted in the United States. ARTHUR ANDERSEN LLP Roseland, New Jersey January 15, 2001 29 30 ALTEON INC. BALANCE SHEETS ASSETS
December 31, December 31, 2000 1999 ------------- ------------- Current Assets: Cash and cash equivalents ................................ $ 3,600,328 $ 5,335,529 Short-term investments ................................... 6,354,479 7,034,258 Other current assets ..................................... 1,735,660 248,983 ------------- ------------- Total current assets ................................ 11,690,467 12,618,770 Property and equipment, net .............................. 1,696,082 2,399,305 Deposits and other assets ................................ 2,815 2,815 ------------- ------------- Total assets ........................................ $ 13,389,364 $ 15,020,890 ============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities: Accounts payable ......................................... $ 304,779 $ 431,000 Accrued expenses ......................................... 1,631,579 1,763,202 ------------- ------------- Total current liabilities ........................... 1,936,358 2,194,202 ------------- ------------- Stockholders' Equity: Preferred Stock, $0.01 par value, 1,993,329 shares authorized, and 912 and 839 of Series G and 2,739 and 2,518 of Series H shares issued and outstanding, as of December 31, 2000 and December 31, 1999, respectively ..................... 37 34 Common Stock, $0.01 par value, 40,000,000 shares authorized, and 22,399,660 and 19,189,701 shares issued and outstanding, as of December 31, 2000 and December 31, 1999, respectively 223,997 191,897 Additional paid-in capital ............................... 145,241,265 134,129,513 Accumulated deficit ...................................... (134,011,423) (121,496,049) Accumulated other comprehensive (loss)/income ............ (870) 1,293 ------------- ------------- Total stockholders' equity .......................... 11,453,006 12,826,688 ------------- ------------- Total liabilities and stockholders' equity .................... $ 13,389,364 $ 15,020,890 ============= =============
The accompanying notes are an integral part of these balance sheets. 30 31 ALTEON INC. STATEMENTS OF OPERATIONS
Year ended December 31, ---------------------------------------------- 2000 1999 1998 ------------ ------------ ------------ Revenues: Investment income ................................. $ 570,444 $ 834,661 $ 1,320,538 Other income ...................................... -- 600,000 -- ------------ ------------ ------------ Total revenues .............................. 570,444 1,434,661 1,320,538 ------------ ------------ ------------ Expenses: Research and development .......................... 6,022,315 10,598,008 24,591,769 Elimination of previously accrued loss contingency -- -- (1,770,975) General and administrative ........................ 4,422,146 4,356,447 4,842,176 Non-cash stock compensation ....................... 1,243,669 -- -- Interest .......................................... -- -- 3,610 ------------ ------------ ------------ Total expenses .............................. 11,688,130 14,954,455 27,666,580 ------------ ------------ ------------ Loss before income tax benefit ...................... (11,117,686) (13,519,794) (26,346,042) Income tax benefit .................................. 1,547,763 2,588,210 -- ------------ ------------ ------------ Net loss ............................................ (9,569,923) (10,931,584) (26,346,042) Preferred stock dividends and discount amortization 2,945,451 2,707,844 2,207,205 ------------ ------------ ------------ Net loss applicable to common stockholders .......... $(12,515,374) $(13,639,428) $(28,553,247) ============ ============ ============ Basic and diluted loss per share to common stockholders ............................... $ (0.63) $ (0.72) $ (1.57) ============ ============ ============ Weighted average common shares used in computing basic and diluted loss per share .................. 19,860,847 19,054,750 18,210,902 ============ ============ ============
The accompanying notes are an integral part of these statements. 31 32 ALTEON INC. STATEMENTS OF STOCKHOLDERS' EQUITY
Preferred Stock Common Stock ------------------------------ ----------------------------- Shares Amount Shares Amount ------------- ------------- ------------- ------------- Balances at DECEMBER 31, 1997 .................. 942 $ 9 17,922,319 $ 179,223 Net loss .......................... -- -- -- -- Change in unrealized gains/(losses) -- -- -- -- Comprehensive loss ................ -- -- -- -- Issuance of Series H preferred stock valued at $10,000 per share to Genentech, Inc., net of transaction costs ............. 2,254 23 -- -- Issuance of Series G and H preferred stock dividends ........ 133 1 -- -- Conversion of Series G preferred stock to common stock ............ (243) (2) 822,204 8,222 Preferred stock discount amortization ..................... -- -- -- -- Exercise of employee stock options .......................... -- -- 70,217 702 Deferred compensation expense in connection with the issuance of non-qualified stock options and options granted to non- employees ........................ -- -- -- -- ------------- ------------- ------------- ------------- DECEMBER 31, 1998 .................. 3,086 31 18,814,740 188,147 Net loss .......................... -- -- -- -- Change in unrealized gains/(losses) -- -- -- -- Comprehensive loss ................ -- -- -- -- Issuance of Series G and H preferred stock dividends ........ 271 3 -- -- Exercise of employee stock options .......................... -- -- 374,961 3,750 Deferred compensation expense in connection with the issuance of non-qualified stock options and options granted to non- employees ........................ -- -- -- -- ------------- ------------- ------------- ------------- DECEMBER 31, 1999 .................. 3,357 34 19,189,701 191,897 Net loss .......................... -- -- -- -- Change in unrealized gains/(losses) -- -- -- -- Comprehensive loss ................ -- -- -- -- Issuance of Series G and H preferred stock dividends ........ 294 3 -- -- Exercise of employee stock options .......................... -- -- 375,871 3,759 Private placement of common stock and warrants ............... -- -- 2,834,088 28,341 Compensation expense related to variable plan employee stock options .................... -- -- -- -- Deferred compensation expense in connection with the issuance of non-qualified stock options and options granted to non- employees ........................ -- -- -- -- ------------- ------------- ------------- ------------- DECEMBER 31, 2000 .................. 3,651 $ 37 22,399,660 $ 223,997 ============= ============= ============= =============
Accumulated Additional Other Total Paid-in Accumulated Comprehensive Stockholders' Capital Deficit Income (Loss) Equity ------------- ------------- ------------- ------------- Balances at DECEMBER 31, 1997 .................. $ 105,585,019 $ (79,303,374) $ (5,941) $ 26,454,936 Net loss .......................... -- (26,346,042) -- (26,346,042) Change in unrealized gains/(losses) -- -- 7,709 7,709 ------------- Comprehensive loss ................ -- -- -- (26,338,333) ------------- Issuance of Series H preferred stock valued at $10,000 per share to Genentech, Inc., net of transaction costs ............. 22,543,706 -- -- 22,543,729 Issuance of Series G and H preferred stock dividends ........ 1,327,768 (1,327,768) -- 1 Conversion of Series G preferred stock to common stock ............ (8,220) -- -- -- Preferred stock discount amortization ..................... 879,437 (879,437) -- -- Exercise of employee stock options .......................... 195,451 -- -- 196,153 Deferred compensation expense in connection with the issuance of non-qualified stock options and options granted to non- employees ........................ 481,872 -- -- 481,872 ------------- ------------- ------------- ------------- DECEMBER 31, 1998 .................. 131,005,033 (107,856,621) 1,768 23,338,358 Net loss .......................... -- (10,931,584) -- (10,931,584) Change in unrealized gains/(losses) -- -- (475) (475) ------------- Comprehensive loss ................ -- -- -- (10,932,059) ------------- Issuance of Series G and H preferred stock dividends ........ 2,707,841 (2,707,844) -- -- Exercise of employee stock options .......................... 162,691 -- -- 166,441 Deferred compensation expense in connection with the issuance of non-qualified stock options and options granted to non- employees ........................ 253,948 -- -- 253,948 ------------- ------------- ------------- ------------- DECEMBER 31, 1999 .................. 134,129,513 (121,496,049) 1,293 12,826,688 Net loss .......................... -- (9,569,923) -- (9,569,923) Change in unrealized gains/(losses) -- -- (2,163) (2,163) ------------- Comprehensive loss ................ -- -- -- (9,572,086) ------------- Issuance of Series G and H preferred stock dividends ........ 2,945,448 (2,945,451) -- -- Exercise of employee stock options .......................... 500,786 -- -- 504,545 Private placement of common stock and warrants ............... 6,103,151 -- -- 6,131,492 Compensation expense related to variable plan employee stock options .................... 1,243,669 -- -- 1,243,669 Deferred compensation expense in connection with the issuance of non-qualified stock options and options granted to non- employees ........................ 318,698 -- -- 318,698 ------------- ------------- ------------- ------------- DECEMBER 31, 2000 .................. $ 145,241,265 $(134,011,423) $ (870) $ 11,453,006 ============= ============= ============= =============
The accompanying notes are an integral part of these statements. 32 33 ALTEON INC. STATEMENTS OF CASH FLOWS
Year ended December 31, ----------------------------------------------- 2000 1999 1998 ------------- ------------- ------------- Cash flows from operating activities: Net loss .............................................. $ (9,569,923) $ (10,931,584) $ (26,346,042) Adjustments to reconcile net loss to cash used in operating activities: Depreciation and amortization ......................... 765,601 743,820 678,773 Amortization of deferred compensation ................. 318,698 253,948 481,872 Non-cash compensation expense related to variable plan employee stock options ............. 1,243,669 -- -- Changes in operating assets and liabilities: Other current assets .................................. (1,486,677) 25,162 194,535 Other assets .......................................... -- 257,265 1,278 Accounts payable and accrued expenses ................. (257,844) (2,119,073) (2,577,746) ------------- ------------- ------------- Net cash used in operating activities ............. (8,986,476) (11,770,462) (27,567,330) ------------- ------------- ------------- Cash flows from investing activities: Capital expenditures .................................. (62,377) (157,969) (480,566) Purchases of marketable securities .................... (11,550,202) (54,461,475) (115,976,783) Sales and maturities of marketable securities ......... 12,227,817 60,719,408 111,241,889 Restricted cash ....................................... -- -- 620,400 ------------- ------------- ------------- Net cash provided by (used in) investing activities 615,238 6,099,964 (4,595,060) ------------- ------------- ------------- Cash flows from financing activities: Net proceeds from issuance of common stock ............ 6,636,037 166,441 196,153 Net proceeds from issuance of preferred stock ......... -- -- 22,543,729 Payments under capital lease obligations .............. -- -- (161,581) ------------- ------------- ------------- Net cash provided by financing activities ......... 6,636,037 166,441 22,578,301 ------------- ------------- ------------- Net decrease in cash and cash equivalents ................. (1,735,201) (5,504,057) (9,584,089) Cash and cash equivalents, beginning of period ............ 5,335,529 10,839,586 20,423,675 ------------- ------------- ------------- Cash and cash equivalents, end of period .................. $ 3,600,328 $ 5,335,529 $ 10,839,586 ============= ============= ============= Supplemental disclosures of cash flow information: Cash paid for interest ............................. $ -- $ -- $ 3,610 ============= ============= =============
The accompanying notes are an integral part of these statements. 33 34 ALTEON INC. NOTES TO FINANCIAL STATEMENTS NOTE 1 -- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization and Business Alteon Inc. ("Alteon" or the "Company") is a product-based biopharmaceutical company engaged in the discovery and development of oral drugs for the treatment of diseases of aging and diabetes. The Company's product candidates represent novel approaches to some of the largest pharmaceutical markets, such as cardiovascular and kidney diseases. The Company conducts its business in one operating segment. Alteon's proprietary technology focuses on Advanced Glycosylation End-products ("A.G.E.s"). A.G.E.s ultimately form crosslinks with adjacent proteins, leading to a loss of flexibility and function in body tissues, vessels and organs. All of the Company's products are in research or development, and no revenues have been generated from product sales. The Company's lead A.G.E. Crosslink Breaker compound, ALT-711, is initially being developed for cardiovascular indication, including isolated systolic hypertension ("ISH"). Alteon recently completed a Phase IIa trial to evaluate the effect of ALT-711 on cardiovascular compliance. Based on the positive results of this trial, the Company plans to initiate a Phase IIb efficacy trial of ALT-711. The Company is seeking a corporate partner to help fund the continued development of its lead A.G.E.-Formation Inhibitor, Pimagedine, based on the results of a Phase II/III trial of Pimagedine in Type 1 diabetic patients with overt nephropathy. Alteon is also pursuing the development of a novel series of glucose lowering agent compounds. The Company's business is subject to significant risks including, but not limited to, (i) its ability to obtain funding, (ii) its uncertainty of future profitability, (iii) the risks inherent in its research and development efforts, including clinical trials, (iv) uncertainties associated with obtaining and enforcing its patents and with the patent rights of others, (v) the lengthy, expensive and uncertain process of seeking regulatory approvals, (vi) uncertainties regarding government reforms and product pricing and reimbursement levels, (vii) technological change and competition, (viii) manufacturing uncertainties and (ix) dependence on collaborative partners and other third parties. Even if the Company's product candidates appear promising at an early stage of development, they may not reach the market for numerous reasons. Such reasons include the possibilities that the products will prove ineffective or unsafe during clinical trials, will fail to receive necessary regulatory approvals, will be difficult to manufacture on a large scale, will be uneconomical to market or will be precluded from commercialization by proprietary rights of third parties. Alteon will require substantial additional funding in order to continue the research, product development, pre-clinical testing and clinical trials of its product candidates. If adequate funding is not available, the Company may be required to curtail significantly one or more of its research or development programs and other Company activities. Pervasiveness of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of 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. 34 35 ALTEON INC. NOTES TO FINANCIAL STATEMENTS - (CONTINUED) Cash and Cash Equivalents and Short-Term Investments Cash and cash equivalents include cash and highly liquid investments, which have a maturity of less than three months at the time of purchase. Short-term investments are considered available-for-sale and are recorded at fair market value, as determined by quoted market value. As of December 31, 2000, short-term investments were invested in debt instruments of the U.S. government, government agencies, financial institutions and corporations with strong credit ratings. They consist of the following:
December 31, ----------------------- 2000 1999 ---------- ---------- U.S. government agency funds... $2,651,255 $ -- Corporate obligations ......... 3,703,224 7,034,258 ---------- ---------- $6,354,479 $7,034,258 ========== ==========
The amortized cost of short-term investments was $6,353,732 and $7,033,844 at December 31, 2000 and December 31, 1999, respectively. Gross unrealized gains or losses are not significant. Property and Equipment Property and equipment are stated at cost. Depreciation and amortization are computed using the straight-line method over the useful lives of owned assets, which range from three to five years. Leasehold improvements and equipment under capital leases are amortized using the straight-line method over the shorter of the lease term or the useful life of the assets. Research and Development Expenditures for research and development are charged to operations as incurred. Stock-Based Compensation The Company accounts for employee stock-based compensation under Accounting Principles Board Opinion No. 25 ("APB Opinion No. 25") and related interpretations. Net Loss Per Share Basic loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares outstanding during the year. Diluted loss per share is the same as basic loss per share, as the inclusion of common stock equivalents would be antidilutive. Comprehensive Income/(Loss) The only comprehensive income/(loss) items the Company has are unrealized gains/(losses) on available-for-sale investments and net loss. 35 36 ALTEON INC. NOTES TO FINANCIAL STATEMENTS - (CONTINUED) Recently Issued Accounting Standards In June 2000, the Financial Accounting Standards Board ("FASB") issued Statement of Financial Accounting Standard No. 138 ("SFAS 138"), "Accounting for Certain Derivative Instruments and Certain Hedging Activities, an Amendment of FASB Statement No. 133." SFAS No. 138 was issued to address a limited number of issues causing implementation difficulties for entities that apply SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activities," issued in June 1998. SFAS No. 133 and SFAS No. 138 require that all derivatives be measured at fair value and recognized as assets or liabilities on the balance sheet. Changes in the fair value of derivatives should be recognized in either net income/(loss) or other comprehensive income/(loss), depending on the designated purpose of the derivative. The Company is required to and will adopt SFAS No. 133 and SFAS No. 138 in the first quarter of 2001. Based on the Company's current activities, the Company does not believe that adoption of these pronouncements will have a material impact on the Company's results of operations, cash flows or financial position. In March 2000, the FASB released Interpretation No. 44, "Accounting for Certain Transactions Involving Stock Compensation, An Interpretation of APB Opinion No. 25." The interpretation became effective on July 1, 2000, but in some circumstances applies to transactions that occurred prior to the effective date. Under the interpretation, stock options that are repriced must be accounted for as variable-plan arrangements until the options are exercised, forfeited or expire. This requirement applies to any options repriced after December 15, 1998. On February 2, 1999, the Company repriced certain stock options (See Note 7). The total non-cash stock compensation expense resulting from the repricing for the year ended December 31, 2000, is $1,244,000, which includes research and development charges of $353,000 and general and administrative charges of $891,000. In December 1999, the Securities and Exchange Commission ("SEC") issued Staff Accounting Bulletin No. 101 ("SAB 101"), "Revenue Recognition in Financial Statements." SAB 101 summarizes certain of the SEC's views in applying generally accepted accounting principles to revenue recognition in financial statements. The adoption of SAB 101 had no impact on the accompanying financial statements. Reclassifications Certain prior year amounts have been reclassified to conform to current year presentation. NOTE 2 -- PROPERTY AND EQUIPMENT
December 31, -------------------------- 2000 1999 ----------- ----------- Laboratory equipment ........................ $ 1,167,780 $ 1,261,640 Furniture and equipment ..................... 686,560 682,124 Computer equipment .......................... 374,589 360,713 Leasehold improvements ...................... 5,215,069 5,215,069 ----------- ----------- 7,443,998 7,519,546 Less: Accumulated depreciation & amortization (5,747,916) (5,120,241) ----------- ----------- $ 1,696,082 $ 2,399,305 =========== ===========
Depreciation and amortization expense was $765,601, $743,820 and $678,773 for the years ended December 31, 2000, 1999 and 1998, respectively. 36 37 ALTEON INC. NOTES TO FINANCIAL STATEMENTS - (CONTINUED) NOTE 3 -- COLLABORATIVE RESEARCH AND DEVELOPMENT AGREEMENT In December 1997, Alteon and Genentech, Inc. ("Genentech") entered into a stock purchase agreement and a development collaboration and license agreement providing for the development and marketing of Pimagedine, a second-generation A.G.E.-Formation Inhibitor. Pursuant to the stock purchase agreement, Genentech purchased Common Stock, Series G Preferred Stock and Series H Preferred Stock for an aggregate purchase price of $37,544,000 (See Note 7). Genentech's obligations to purchase shares of Alteon's stock terminated December 31, 1998. Pursuant to a letter agreement dated February 11, 1999 between Alteon and Genentech, the development collaboration and license agreement terminated effective June 30, 1999. NOTE 4 -- OTHER DEVELOPMENT AGREEMENTS In 1989, Alteon and Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi") formed a strategic alliance to develop and commercialize the Company's A.G.E. technology. Under this arrangement, the parties agreed to collaborate on further research and development, and the Company granted to Yamanouchi an exclusive license to commercialize the Company's technology in Japan, South Korea, Taiwan and The People's Republic of China. In June 1995, the Company obtained an exclusive, worldwide, royalty-bearing license from Washington University for patents covering the use of Pimagedine as an inhibitor of inducible nitric oxide synthase. The agreement requires the Company to pay certain licensing fees upon the attainment of development milestones as well as a royalty on net sales or a share of sub-licensing profits of products covered by the patents. The license also covers patents developed through any subsequent research collaboration between the parties, which Alteon agrees to fund. In August 1999, Alteon and Taisho Pharmaceutical Co., Ltd. ("Taisho") entered into an agreement under which Taisho was granted an exclusive option through December 31, 1999, to acquire a license to Alteon's lead A.G.E. Crosslink Breaker, ALT-711, for Japan, South Korea, Taiwan and The People's Republic of China for a non-refundable option fee of $600,000. This amount is reflected in other income in the statement of operations. The option expired on December 31, 1999. In October 2000, Alteon entered into an agreement with HemoMax, LLC ("HemoMax") for the development of a novel technology designed to increase the delivery of oxygen to tissues in the body through enhanced blood circulation. Under the agreement, HemoMax will fund the pre-clinical development of compounds arising from the technology, and Alteon will directly manage the development programs. HemoMax has granted Alteon an exclusive right of first refusal to acquire the HemoMax technology. In addition, based on the achievement of certain milestones, Alteon will receive 15% ownership of HemoMax. While this technology is not currently a part of our main technology platform, we entered into this relationship because it represents an opportunity to participate in the development of and potentially to acquire a technology that complements our cardiovascular activities with ALT-711. Alteon's commercial partners may develop, either alone or with others, products that compete with the development and marketing of the Company's products. Competing products, either developed by the commercial partners or to which the commercial partners have rights, may result in their withdrawal of support with respect to all or a portion of the Company's technology, which would have a material adverse effect on the Company's business, financial condition and results of operations. The Company has also entered into various arrangements with independent research laboratories to conduct studies in conjunction with the development of the Company's technology. The Company receives certain rights to inventions or discoveries that may arise from this research. 37 38 ALTEON INC. NOTES TO FINANCIAL STATEMENTS - (CONTINUED) NOTE 5 -- ACCRUED EXPENSES
December 31, ------------------------ 2000 1999 ---------- ---------- Accrued clinical trial expense ..... $ 848,745 $ 923,756 Accrued professional fees .......... 291,000 145,769 Accrued payroll and related expenses 167,680 402,288 Accrued rent ....................... 155,585 210,498 Accrued patent fees ................ 111,529 20,000 Other .............................. 57,040 60,891 ---------- ---------- $1,631,579 $1,763,202 ========== ==========
The Company's headquarters and research facility rent is being expensed on a straight-line basis over the 10-year lease period (See Note 6). NOTE 6 -- CONTINGENCIES AND COMMITMENTS Contingencies In December 1990, the Company and Marion Merrell Dow, Inc., which was subsequently acquired by an affiliate of Hoechst AG and renamed Hoechst Marion Roussel, Inc. ("HMRI"), formed a strategic alliance to develop and commercialize the Company's A.G.E. technology for therapeutics in the areas of diabetic and aging complications. In 1996, HMRI ended the collaboration as a result of HMRI's continuing prioritization of its new product pipeline, and the Company regained all rights granted to HMRI covering the Company's technology. In June 1998, the Company and HMRI resolved various open issues arising from the termination of their collaboration. As a result, the previously established accrual in the amount of $1.8 million has been eliminated and credited to the statement of operations. Commitments The Company leases its headquarters and research facility and related equipment and furniture under non-cancelable operating leases. As of December 31, 2000, future minimum rentals under operating leases that have initial or remaining non-cancelable terms in excess of one year are as follows:
Operating Leases ---------- 2001 ........ $ 536,500 2002 ........ 536,500 2003 ........ 447,000 Thereafter... -- ---------- $1,520,000 ==========
Rent expense for each of the years in the three-year period ended December 31, 2000, was $586,294, $573,962 and $584,510, respectively. 38 39 ALTEON INC. NOTES TO FINANCIAL STATEMENTS - (CONTINUED) NOTE 7 -- STOCKHOLDERS' EQUITY Common/Preferred Stock Issuances In September 2000, Alteon entered into an agreement with several investors pursuant to which we sold them, in a private placement, an aggregate of 2,834,088 shares of common stock and warrants to purchase 1,133,636 shares of common stock (the "Warrants") for an aggregate purchase price of $6,235,000. The exercise price of the Warrants is $3.40 per share, while the term is seven years. In December 1997, the Company and Genentech entered into a stock purchase agreement pursuant to which Genentech agreed to buy shares of Common Stock, Series G Preferred Stock and Series H Preferred Stock (See Note 3). In December 1997, Genentech purchased Common Stock and Series G Preferred Stock for an aggregate purchase price of $15,000,000. On July 27, 1998 and October 1, 1998, Genentech purchased $8,000,000 and $14,544,000 respectively, of Series H Preferred Stock. As of December 31, 2000 and 1999, respectively, approximately $2,945,000 and $2,708,000 of Preferred Stockholder Dividends and amortization of Preferred Stock conversion discount were recorded. Series G Preferred Stock and Series H Preferred Stock Dividends are payable quarterly in shares at a rate of 8.5%. Each share of Series G Preferred Stock and Series H Preferred Stock is convertible upon 70 days' prior written notice into a number of shares of Common Stock determined by dividing $10,000 by the average of the closing sales price of the Common Stock, as reported on the American Stock Exchange for the 20 business days immediately preceding the date of conversion. Stock Option Plan The Company has established two stock option plans for its employees, officers, directors, consultants and independent contractors. Options to purchase up to 4,192,000 shares of Common Stock may be granted under the first plan and options to purchase up to 4,000,000 shares of common stock may be granted under the second plan. The plans are administered by a committee of the Board of Directors, which may grant either non-qualified or incentive stock options. The committee determines the exercise price and vesting schedule at the time the option is granted. Options vest over various periods and may expire no later than 10 years from date of grant. Each option entitles the holder to purchase one share of Common Stock at the indicated exercise price. The plans also provide for certain antidilution and change in control rights, as defined. The following table summarizes the activity in the Company's stock options:
Exercise Weighted Average Price Range Exercise Price Options Per Share Per Share ----------- ------------ ---------------- Balance, December 31, 1997 3,659,440 $ 6.51 Granted .................. 1,232,950 0.88 - 8.50 1.98 Exercised ................ (70,217) 0.30 - 8.63 2.79 Canceled ................. (22,913) 3.88 - 15.00 8.72 ---------- ------- Balance, December 31, 1998 4,799,260 $ 5.39 Granted .................. 1,928,701 0.78 - 1.125 0.99 Exercised ................ (374,961) 0.30 - 0.60 0.44 Canceled ................. (1,277,804) 0.81 - 15.00 3.88 ---------- ------- Balance, December 31, 1999 5,075,196 $ 3.40 Granted .................. 1,083,420 1.63 - 7.00 4.57 Exercised ................ (375,871) 0.60 - 5.13 1.34 Canceled ................. (550,326) 0.60 - 9.50 1.12 ---------- ------- Balance, December 31, 2000 5,232,419 $ 4.03 ========== =======
39 40 ALTEON INC NOTES TO FINANCIAL STATEMENTS - (CONTINUED) The following table summarizes information regarding stock options outstanding at December 31, 2000:
Options Outstanding at Options Exercisable at December 31, 2000 December 31, 2000 --------------------------------------------- ------------------------- Weighted Weighted Weighted Range of Average Average Number of Average Exercise Number of Remaining Exercise Shares Exercise Prices Shares Contractual Life Price Exercisable Price ------------------ --------- ---------------- -------- ----------- -------- $0.7810 - $ 1.0630 1,880,218 6.56 $ 0.9590 1,277,322 $ 0.9554 $1.1250 - $ 3.8750 1,424,125 8.78 $ 2.5223 847,890 $ 2.0675 $4.3600 - $ 9.2500 1,457,387 5.51 $ 7.2395 1,041,595 $ 7.4239 $9.5000 - $15.0000 470,689 2.99 $10.8932 470,689 $10.8932 --------- ---- -------- --------- -------- 5,232,419 6.55 $ 4.0274 3,637,496 $ 4.3528
The weighted average fair value of the options granted was $2.54, $0.53 and $1.71 during 2000, 1999 and 1998, respectively. Included in options at December 31, 2000, are 835,000 options granted to certain executives with option prices ranging from $.875 per share to $3.56 per share. Such options vest upon the earlier of five years after grant or upon achievement of certain Company milestones. The Company accounts for its stock option plans under APB Opinion No. 25, under which no compensation cost (excluding those options granted below fair market value) has been recognized. Had compensation costs for these plans been determined consistent with FASB Statement No. 123, the Company's pro forma net loss and loss per share applicable to common stockholders for 2000, 1999 and 1998 would have been $13.7 million, $13.9 million and $30.5 million and, $0.69, $0.73 and $1.67, respectively. The 2000 pro forma net loss and loss per share applicable to common stockholders reflects a benefit for the reversal of previously recognized pro forma compensation costs on options forfeited in 2000. Consistent with FASB Statement No. 123, the Company elected not to estimate these forfeitures in the prior period pro forma compensation cost calculation. Because FASB Statement No. 123 has not been applied to options granted prior to January 1, 1995, the resulting pro forma compensation cost may not be representative of that to be expected in future years. Under FASB Statement No. 123, the fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions used for grants in 2000, 1999 and 1998, respectively: risk free interest rates ranging 5.24% to 6.64%, 4.73% to 6.07% and 4.32% to 5.63%, respectively; expected life of 2.02 years over the vesting periods; expected dividend yield of 0%; and expected volatility of 70%. In February 1999, the Board of Directors approved the repricing of 1,063,000 stock options outstanding as of February 2, 1999 (See Note 1). NOTE 8 -- SAVINGS AND RETIREMENT PLAN The Company maintains a savings and retirement plan under Section 401(k) of the Internal Revenue Code which allows eligible employees to annually contribute a portion of their annual salary to the plan. In 1998, the Company began making discretionary contributions at a rate of 25% of an employee's contribution up to a maximum of 5% of the employee's base salary. The Company made contributions of $30,530 and $49,000 for the years ended December 31, 2000 and 1999, respectively. 40 41 ALTEON INC. NOTES TO FINANCIAL STATEMENTS - (CONTINUED) NOTE 9 -- RELATED PARTY TRANSACTIONS Since the Company's inception, the Company has entered into certain collaborative agreements with organizations with which Dr. Anthony Cerami, a former member of the Company's Board of Directors, was affiliated. These organizations included The Picower Institute for Medical Research ("The Picower Institute"), The Rockefeller University, Cerami Consulting Corporation and the Kenneth S. Warren Laboratories, Inc. The Company paid to the organizations $0, $243,000 and $731,000 in 2000, 1999, and 1998, respectively. In addition, the Company paid patent maintenance fees for technology related to the organizations of $120,000, $73,000 and $207,000 in 2000, 1999 and 1998, respectively. Although the Company has terminated its collaborative relationship with The Picower Institute, the Company has a royalty obligation on all net sales and other revenues associated with certain technologies developed. Effective May 17, 1999, the Company terminated its consulting agreement with Cerami Consulting Corporation and its research agreement with Kenneth S. Warren Laboratories, Inc. In addition, Dr. Cerami resigned from the Company's Board of Directors on April 19, 1999. Prior to 2000, the Company had a Scientific Advisory Board. The Chairman and two other Scientific Advisory Board members provided consulting services to the Company. Consulting fees paid to these members totaled $55,000 and $89,000 in 1999 and 1998, respectively. NOTE 10 -- INCOME TAXES At December 31, 2000, the Company had available Federal net operating loss carryforwards, which expire in the years 2006 through 2020, of approximately $125.9 million for income tax purposes and State net operating loss carryforwards, which expire in the years 2000 through 2007, of approximately $81.8 million. In addition, the Company has Federal research and development tax credit carryforwards of approximately $4.9 million and State research and development tax credit carryforwards of approximately $2.2 million. The amount of Federal net operating loss and research and development tax credit carryforwards which can be utilized in any one period may become limited by Federal income tax regulations if a cumulative change in ownership of more than 50% occurs within a three-year period. The components of the deferred tax assets and the valuation allowance are as follows:
December 31, ----------------------------- 2000 1999 ------------ ------------ Net operating loss carryforwards $ 47,700,000 $ 42,900,000 Research and development credit 7,100,000 7,000,000 Other temporary differences .... 2,400,000 4,700,000 ------------ ------------ Gross deferred tax assets ...... 57,200,000 54,600,000 Valuation allowance ............ (57,200,000) (54,600,000) ------------ ------------ Net deferred tax assets ........ $ -- $ -- ============ ============
A valuation allowance was established since the realization of the deferred tax assets is uncertain. In 2000 and 1999, Alteon sold $14.1 million and $27.6 million, respectively, of our gross State net operating loss carryforwards and $590,000 and $645,000, respectively, of our State research and development tax credit carryforwards under the State of New Jersey's Technology Business Tax Certificate Transfer Program (the "Program"). The Program allowed qualified technology and biotechnology business in New Jersey to sell unused amounts of net operating loss carryforwards and defined research and development tax credits for cash. The sales prices in 2000 and 1999 were $1,548,000 and $2,588,000, respectively, and such amounts were recorded as a tax benefit in the statements of operations. The proceeds from the sale of the net operating loss carryforwards and the research and development tax credit carryforwards sold in 2000 were received on January 8, 2001. Accordingly, as of December 31, 2000, $1,548,000 is included in other current assets. 41 42 EXHIBIT INDEX
Exhibit No. Description of Exhibit - ------- ---------------------- 3.1 Restated Certificate of Incorporation, as amended. (Incorporated by reference to Exhibit 3.1 to the Company's Report on Form 10-Q filed on November 10, 1999). 3.2 Certificate of the Voting Powers, Designations, Preference and Relative Participating, Optional and Other Special Rights and Qualifications, Limitations or Restrictions of Series F Preferred Stock of the Company. 3.3 Certificate of Retirement dated September 10, 2000, of Alteon Inc. (Incorporated by reference to Exhibit 3.1 to the Company's Report on Form 10-Q filed on November 10, 1999). 3.4 Certificate of Designations of Series G Preferred Stock of Alteon Inc. (Incorporated by reference to Exhibit 3.4 to the Company's Annual Report on Form 10-K for the year ended December 31, 1997). 3.5 Certificate of Amendment of Certificate of Designations of Series G Preferred Stock of Alteon Inc. (Incorporated by reference to Exhibit 3.4 to the Company's Report on Form 10-Q filed on August 14, 1998). 3.6 Certificate of Designations of Series H Preferred Stock of Alteon Inc. (Incorporated by reference to Exhibit 3.5 to the Company's Annual Report on Form 10-K for the year ended December 31, 1997). 3.7 Amended Certificate of Designations of Series H Preferred Stock of Alteon Inc. (Incorporated by reference to Exhibit 3.6 to the Company's Report on Form 10-Q filed on August 14, 1998). 3.8 Certificate of Retirement dated November 20, 2000, of Alteon Inc. 3.9 By-laws, as amended. (Incorporated by reference to Exhibit 3.7 to the Company's Report on Form 10-Q filed on May 12, 1999). 4.1 Stockholders' Rights Agreement dated as of July 27, 1995, between Alteon Inc. and Registrar and Transfer Company, as Rights Agent. 4.2 Amendment to Stockholders' Rights Agreement dated as of April 24, 1997, between Alteon Inc. and Registrar and Transfer Company, as Rights Agent. (Incorporated by reference to Exhibit 4.4 to the Company's Current Report on Form 8-K filed on May 9, 1997). 4.3 Registration Rights Agreement dated as of April 24, 1997, between Alteon Inc. and the investors named on the signature page thereof. (Incorporated by reference to Exhibit 4.1 to the Company's Current Report on Form 8-K filed on May 9, 1997). 4.4 Form of Common Stock Purchase Warrant. (Incorporated by reference to Exhibit 4.2 to the Company's Current Report on Form 8-K filed on May 9, 1997). 4.5 Amendment to Stockholders' Rights Agreement dated as of December 1, 1997, between Alteon Inc. and Registrar and Transfer Company, as Rights Agent. (Incorporated by reference to Exhibit 4.1 to the Company's Current Report on Form 8-K filed on December 10, 1997). 4.6 Registration Rights Agreement dated September 29, 2000. (Incorporated by reference to Exhibit 4.1 to the Company's Current Report on Form 8-K filed on October 5, 2000). 4.7 Form of Series 1 Common Stock Purchase Warrant. (Incorporated by reference to Exhibit 4.2 to the Company's Current Report on Form 8-K filed on October 5, 2000).
43 4.8 Form of Series 2 Common Stock Purchase Warrant. (Incorporated by reference to Exhibit 4.3 to the Company's Current Report on Form 8-K filed on October 5, 2000). 10.1+ Amended and Restated 1987 Stock Option Plan. (Incorporated by reference to Exhibit 10.1 to the Company's Annual Report on Form 10-K for the year ended December 31, 1997). 10.2+ Amended 1995 Stock Option Plan. (Incorporated by reference to Exhibit 10.2 to the Company's Report on Form 10-Q filed May 12, 1999). 10.3 Form of Employee's or Consultant's Invention Assignment, Confidential Information and Non-Competition Agreement executed by all key employees and consultants as employed or retained from time to time. (Incorporated by Reference to Exhibit 10.1 to the Company's Registration Statement on Form S-1 (File Number 33-42574), which became effective on November 1, 1991). 10.4 Amendment and Assignment of Research and Option Agreement dated as of September 25, 1987, among Telos Development Corporation ("Telos"), The Rockefeller University ("The Rockefeller"), the Company and Anthony Cerami. (Incorporated by reference to Exhibit 10.5 to the Company's Registration Statement on Form S-1 (File Number 33-42574), which became effective on November 1, 1991). 10.5 License Agreement dated as of September 25, 1987, among Telos, Applied Immune Sciences, Inc., the Company and The Rockefeller, as amended by letter agreement dated September 25, 1987, and letter agreement dated August 15, 1991. (Incorporated by reference to Exhibit 10.6 to the Company's Registration Statement on Form S-1 (File Number 33-42574), which became effective on November 1, 1991). 10.6* License Agreement dated as of June 16, 1989, between the Company and Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi"). (Incorporated by reference to Exhibit 10.17 to the Company's Registration Statement on Form S-1 (File Number 33-42574), which became effective on November 1, 1991). 10.7* Research and License Agreement dated as of September 5, 1991, between the Company and The Picower Institute for Medical Research. (Incorporated by reference to Exhibit 10.29 to the Company's Registration Statement on Form S-1 (File Number 33-42574), which became effective on November 1, 1991). 10.8 Lease Agreement dated January 11, 1993, between Ramsey Associates and the Company. 10.9* License Agreement dated as of December 30, 1994, between the Company and Corange International Limited. 10.10* Research Collaboration and License Agreement dated as of June 2, 1995, between Washington University and the Company. 10.11 Distribution Agreement dated September 25, 1995, between the Company and Eryphile BV. 10.12+ Employment Agreement dated as of October 21, 2000, between the Company and Elizabeth O'Dell. 10.13+ Alteon Inc. Change in Control Severance Benefits Plan. 10.14 Preferred Stock Investment Agreement dated as of April 24, 1997, between Alteon Inc. and the investors named on the signature page thereof. (Incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on May 9, 1997). 10.15* License and Supply Agreement dated June 17, 1997, between IDEXX Laboratories, Inc. and Alteon Inc. (Incorporated by reference to Exhibit 10.1 to the Company's Report on Form 10-Q filed on August 13, 1997).
44 10.16 Stock Purchase Agreement dated as of December 1, 1997, between Alteon Inc. and Genentech, Inc. (Incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on December 10, 1997). 10.17+ Amended and Restated Employment Agreement dated as of December 15, 1998, between the Company and Kenneth I. Moch. (Incorporated by reference to Exhibit 10.28 to the Company's Annual Report on Form 10-K for the year ended December 31, 1999). 10.18 Letter Agreement dated February 11, 1999, between the Company and Genentech, Inc. (Incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on February 19, 1999). 10.19+ Consulting Agreement dated as of December 15, 1998, between the Company and Mark Novitch, M.D., as amended by letter agreement dated as of January 18, 2001. 10.20+ Employment Agreement dated as of March 14, 2000, between the Company and Robert deGroof, Ph.D. (Incorporated by reference to Exhibit 10.1 to the Company's Report on Form 10-Q filed on May 12, 2000). 10.21 Common Stock and Warrants Purchase Agreement dated as of September 29, 2000, among Alteon Inc. and EGM Medical Technology Fund, L.P., EGM Technology Offshore Fund, Narragansett I, L.P., Narragansett Offshore, Ltd., S.A.C. Capital Associates, LLC, SDS Merchant Fund, LP and Herriot Tabuteau. (Incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on October 5, 2000). 10.22* Development Services Agreement dated September 25, 2000. (Incorporated by reference to Exhibit 10.2 to the Company's Report on Form 10-Q filed on November 13, 2000). 23.1 Consent of Independent Public Accountants.
- ---------- * Confidentiality has been granted for a portion of this exhibit. + Denotes a management contract or compensatory plan or arrangement required to be filed as an exhibit pursuant to Item 14(c) to this Form 10-K.
EX-3.2 2 w46067ex3-2.txt CERTIFICATE OF THE VOTING POWERS 1 Exhibit 3.2 CERTIFICATE OF THE VOTING POWERS, DESIGNATIONS, PREFERENCES AND RELATIVE PARTICIPATING, OPTIONAL AND OTHER SPECIAL RIGHTS AND QUALIFICATIONS, LIMITATIONS OR RESTRICTIONS OF SERIES F PREFERRED STOCK OF ALTEON INC. Pursuant to Section 151 of the General Corporation Law of the State of Delaware, Alteon Inc. (the "Corporation") organized and existing under the General Corporation Law of the State of Delaware, in accordance with the provisions of Section 103 thereof, DOES HEREBY CERTIFY: That, pursuant to the authority conferred upon the Board of Directors of the Corporation by Article Fifth of the Restated Certificate of Incorporation of the Corporation (the "Certificate of Incorporation"), the Board of Directors of the Corporation on July 20, 1995, adopted the following resolution creating a series of Preferred Stock designated as Series F Preferred Stock: RESOLVED, that, pursuant to the authority vested in the Board of Directors of the Corporation in accordance with the provisions of the Certificate of Incorporation of the Corporation, a series of Preferred Stock of the Corporation is hereby created and that the designation and number of shares thereof an the voting powers, preferences and relative, participating, optional and other special rights of the shares of such series, and the qualifications, limitations or restrictions thereof are as follows: SECTION 1. Designation and Number of Shares. The shares of such series shall be designated as "Series F Preferred Stock" (the "Series F Preferred Stock"), par value $0.01 per share. The number of shares initially constituting the Series F Preferred Stock shall be 400,000; provided, however, that, if more than a total of 400,000 shares of Series F Preferred Stock shall be issuable upon the exercise of Rights (the "Rights") issued pursuant to the Stockholders Rights Agreement dated as of July 27, 1995, between the Corporation and Registrar and Transfer Company, as Rights Agent (the "Rights Agreement"), the Board of Directors of the Corporation, pursuant to Section 151(g) of the General Corporation Law of the State of Delaware, shall direct by resolution or resolutions that a certificate be properly executed, acknowledged, filed and recorded, in accordance with the provisions of Section 1 2 Exhibit 3.2 103 thereof, providing for the total number of shares of Series F Preferred Stock authorized to be issued to be increased (to the extent that the Certificate of Incorporation then permits) to the largest number of whole shares (rounded up to the nearest whole number) issuable upon exercise of such Rights. SECTION 2. Dividends or Distributions. (a) Subject to the prior and superior rights of the holders of shares of any other series of Preferred Stock or other class of capital stock of the Corporation ranking prior and superior to the shares of Series F Preferred Stock with respect to dividends, the holders of shares of the Series F Preferred Stock shall be entitled to receive, when, as and if declared by the Board of Directors, out of the assets of the Corporation legally available therefore, (1) quarterly dividends payable in cash on the last day of each fiscal quarter in each year, or such other dates as the Board of Directors of the Corporation shall approve (each such date being referred to herein as a "Quarterly Dividend Payment Date"), commencing on the first Quarterly Dividend Payment Date after the first issuance of a share or a fraction of a share of Series F Preferred Stock, in the amount of $.01 per whole share (rounded to the nearest cent) less the amount of all cash dividends declared on the Series F Preferred Stock pursuant to the following clause (2) since the immediately preceding Quarterly Dividend Payment Date or, with respect to the first Quarterly Dividend Payment Date, since the first issuance of any share or fraction of a share of Series F Preferred Stock (the total of which shall not, in any event, be less than zero) and (2) dividends payable in cash on the payment date for each cash dividend declared on the Common Stock in an amount per whole share (rounded to the nearest cent) equal to the Formula Number (as hereinafter defined) then in effect times the cash dividends then to be paid on each share of Common Stock. In addition, if the Corporation shall pay any dividend or make any distribution on the Common Stock payable in assets, securities or other forms of noncash consideration (other than dividends or distributions solely in shares of Common Stock), then, in each such case, the Corporation shall simultaneously pay or make on each outstanding whole share of Series F Preferred Stock a dividend or distribution in like kind equal to the Formula Number then in effect times such dividend or distribution on each share of the Common Stock. As used herein, the "Formula Number" shall be 1,000; provided, however, that, if at any time after July 20, 1995, the Corporation shall (i) declare or pay any dividend on the Common Stock payable in shares of Common Stock or make any distribution on the Common Stock in share of Common Stock, (ii) subdivide (by a stock split or otherwise) the outstanding shares of Common Stock into a larger number of shares of Common Stock or (iii) combine (by a reverse stock split or otherwise) the outstanding shares of Common Stock, into a smaller number of shares of Common Stock, then in each such 2 3 Exhibit 3.2 event the Formula Number shall be adjusted to a number determined by multiplying the Formula Number in effect immediately prior to such event by a fraction, the numerator of which is the number of shares of Common Stock that are outstanding immediately after such event and the denominator of which is the number of shares of Common Stock that are outstanding immediately prior to such event (and rounding the result to the nearest whole number); and provided further, that, if an any time after July 20, 1995, the Corporation shall issue any shares of its capital stock in a merger, reclassification, or change of the outstanding shares of Common Stock, then in each such event the Formula Number shall be appropriately adjusted to reflect such merger, reclassification or change so that each share of Preferred Stock continues to be the economic equivalent of a Formula Number of shares of Common Stock prior to such merger, reclassification or change. (b) The Corporation shall declare a dividend or distribution on the Series F Preferred Stock as provided in Section 2(a) immediately prior to or at the same time it declares a dividend or distribution on the Common Stock (other than a dividend or distribution solely in shares of Common Stock); provided, however, that, in the event no dividend or distribution (other than a dividend or distribution in shares of Common Stock) shall have been declared on the Common Stock during the period between any Quarterly Dividend Payment Date and the next subsequent Quarterly Dividend Payment Date, a dividend of $.01 per share on the Series F Preferred Stock shall nevertheless be payable on such subsequent Quarterly Dividend Payment Date. The Board of Directors may fix a record date for the determination of holders of shares of Series F Preferred Stock entitled to receive a dividend or distribution declared thereon, which record date shall be the same as the record date for corresponding dividend or distribution on the Common Stock. (c) Dividends shall begin to accrue and be cumulative on outstanding shares of Series F Preferred Stock from and after the Quarterly Dividend Payment Date next preceding the date of original issue of such shares of Series F Preferred Stock; provided, however, that dividends on such shares which are originally issued after the record date for the determination of holders of shares of Series F Preferred Stock entitled to receive a quarterly dividend and on or prior to the next succeeding Quarterly Dividend Payment Date shall begin to accrue and be cumulative from and after such Quarterly Dividend Payment Date. Notwithstanding the foregoing, dividends on shares of Series F Preferred Stock which are originally issued prior to the record date for the determination of holders of shares of Series F Preferred Stock entitled to receive a quarterly dividend on the first Quarterly Dividend Payment Date shall be calculated as if cumulative from and after the last day of 3 4 Exhibit 3.2 the fiscal quarter next preceding the date of original issuance of such shares. Accrued but unpaid dividends shall not bear interest. Dividends paid on the shares of Series F Preferred Stock in an amount less than the total amount of such dividends at the time accrued and payable on such shares shall be allocated pro rata on a share-by-share basis among all such shares at the time outstanding. (d) So long as any shares of the Series F Preferred Stock are outstanding, no dividends or other distributions shall be declared, paid or distributed, or set aside for payment or distribution, on the Common Stock unless, in each case, the dividend required by this Section 2 to be declared on the Series F Preferred Stock shall have been declared. (e) The holders of the shares of Series F Preferred Stock shall not be entitled to receive any dividends or other distribution except as provided herein. SECTION 3. Voting Rights. The holders of shares of Series F Preferred Stock shall have the following voting rights: (a) Each holder of Series F Preferred Stock shall be entitled to a number of votes equal to the Formula Number then in effect, for each share of Series F Preferred Stock held of record on each matter on which holders of the Common Stock or stockholders generally are entitled to vote, multiplied by the maximum number of votes per share which any holder of the Common Stock or stockholders generally then have with respect to such matter (assuming any holding period or other requirement to vote a greater number of shares is satisfied). (b) Except as otherwise provided herein or by applicable law, the holders of shares of Series F Preferred Stock and the holders of shares of Common Stock shall vote together as one class for the election of directors of the Corporation and on all other matters submitted to a vote of stockholders of the Corporation. (c) If, at the time of any annual meeting of stockholders for the election of directors, the equivalent of six quarterly dividends (whether or not consecutive) payable on any share or shares of Series F Preferred Stock are in default, the number of directors constituting the Board of Directors of the Corporation shall be increased by two. In addition to voting together with the holders of Common Stock for the election of other directors of the Corporation, the holders of record of the Series F Preferred Stock, voting separately as a class to the exclusion of the holders of Common Stock, shall be entitled at said meeting of stockholders (and at each subsequent annual meeting of stockholders), unless all dividends in arrears have been paid or 4 5 Exhibit 3.2 declared and set apart for payment prior thereto, to vote for the election of two directors of the Corporation, the holders of any Series F Preferred Stock being entitled to cast a number of votes per share of Series F Preferred Stock equal to the Formula Number. Until the default in payments of all dividends which permitted the election of said directors shall cease to exist, any director who shall have been so elected pursuant to the next preceding sentence may be removed at any time, either with or without cause, only by the affirmative vote of the holders of the shares of Series F Preferred Stock at the time entitled to cast a majority of the votes entitled to be cast for the election of any such director at a special meeting of such holders called for that purpose, and any vacancy thereby created may be filled by the vote of such holders. If and when such default shall cease to exist, the holders of the Series F Preferred Stock shall be divested of the foregoing special voting rights, subject to revesting in the event of each and every subsequent like default in payments of dividends. Upon the termination of the foregoing special voting rights, the terms of office of all persons who may have been elected directors pursuant to said special voting rights shall forthwith terminate, and the number of directors constituting the Board of Director shall be reduced by two. The voting rights granted by this Section 3(c) shall be in addition to any other voting rights granted to the holders of the Series F Preferred Stock in this Section 3. (d) Except as provided herein, in Section 11 or by applicable law, holders of Series F Preferred Stock shall have no special voting rights and their consent shall not be required (except to the extent they are entitled to vote with holders of Common Stock as set forth herein) for authorizing or taking any corporate action. SECTION 4. Certain Restrictions. (a) Whenever quarterly dividends or other dividends or distributions payable on the Series F Preferred Stock as provided in Section 2 are in arrears, thereafter and until all accrued and unpaid dividends and distributions, whether or not declared, on shares of Series F Preferred Stock outstanding shall have been paid in full, the Corporation shall not (i) declare or pay dividends on, make any other distributions on, or redeem or purchase or otherwise acquire for consideration any shares of stock ranking junior (either as to dividends or upon liquidation, dissolution or winding up) to the Series F Preferred Stock; (ii) Declare or pay dividends on, or make any other distributions on any shares of stock ranking on a parity 5 6 Exhibit 3.2 (either as to dividends or upon liquidation, dissolution or winding up) with the Series F Preferred Stock, except dividends paid ratably on the Series F Preferred Stock and all such parity stock on which dividends are payable or in arrears in proportion to the total amounts to which the holders of all such shares are then entitled; (iii) redeem or purchase or otherwise acquire for consideration shares of any stock ranking on a parity (either as to dividends or upon liquidation, dissolution or winding up) with the Series F Preferred Stock; provided that the Corporation may at any time redeem, purchase or otherwise acquire shares of any such parity stock in exchange for shares of any stock of the Corporation ranking junior (either as to dividends or upon dissolution, liquidation or winding up) to the Series F Preferred Stock; or (iv) purchase or otherwise acquire for consideration any shares of Series F Preferred Stock, or any shares of stock ranking on a parity with the Series F Preferred Stock, except in accordance with a purchase offer made in writing or by publication (as determined by the Board of Directors) to all holders of such shares upon such terms as the Board of Directors, after consideration of the respective annual dividend rates and other relative rights and preferences of the respective series and classes, shall determine in good faith will result in fair and equitable treatment among the respective series or classes. (b) The Corporation shall not permit any subsidiary of the Corporation to purchase or otherwise acquire for consideration any shares of stock of the Corporation unless the Corporation could, under paragraph (a) of this Section 4, purchase or otherwise acquire such shares at such time and in such manner. SECTION 5. Liquidation Rights. Upon the liquidation, dissolution or winding up of the Corporation, whether voluntary or involuntary, no distribution shall be made (1) to the holders of shares of stock ranking junior (either as to dividends or upon liquidation, dissolution or winding up) to the Series F Preferred Stock unless, prior thereto, the holders of shares of Series F Preferred Stock shall have received an amount equal to the accrued and unpaid dividends and distributions thereon, whether or not declared, to the date of such payment, plus an amount equal to the greater of (x) $.01 per whole share or (y) an aggregate amount per share equal to the Formula Number then in effect times the aggregate amount to be distributed per share to holders of Common Stock or (2) to the holders of stock ranking on a parity (either as to dividends or upon liquidation, dissolution or winding up) with 6 7 Exhibit 3.2 the Series F Preferred Stock, except distributions made ratably on the Series F Preferred Stock and all other such parity stock in proportion to the total amounts to which the holders of all such shares are entitled upon such liquidation, dissolution or winding up. SECTION 6. Consolidation, Merger, etc. In case the Corporation shall enter into any consolidation, merger, combination or other transaction in which the shares of Common Stock are exchanged for or changed into other stock or securities, cash or any other property, then in any such case the then outstanding shares of Series F Preferred Stock shall at the same time be similarly exchanged or changed into an amount per share equal to the Formula Number then in effect times the aggregate amount of stock, securities, cash or any other property (payable in kind), as the case may be, into which or for which each share of Common Stock is exchanged or changed. In the event both this Section 6 and Section 2 appear to apply to a transaction, this Section 6 will control. SECTION 7. No Redemption; No Sinking Fund. (a) The shares of Series F Preferred Stock shall not be subject to redemption by the Corporation or at the option of any holder of Series F Preferred Stock except as set forth in the Certificate of Incorporation of the Corporation; provided, however, that the Corporation may purchase or otherwise acquire outstanding shares of Series F Preferred Stock in the open market or by offer to any holder or holders of shares of Series F Preferred Stock. (b) The shares of Series F Preferred Stock shall not be subject to or entitled to the operation of a retirement or sinking fund. SECTION 8. Ranking. The Series F Preferred Stock shall rank junior to all other series of Preferred Stock of the Corporation, unless the Board of Directors shall specifically determine otherwise in fixing the powers, preferences and relative, participating, optional and other special rights of the shares of such series and the qualifications, limitations and restrictions thereof. SECTION 9. Fractional Shares. The Series F Preferred Stock shall be issuable upon exercise of the Rights issued pursuant to the Rights Agreement in whole shares or in any fraction of a share that is one one-thousandths (1/1,000ths) of a share of any integral multiple of such fraction which shall entitle the holder, in proportion to such holder's fractional shares, to receive dividends, exercise voting rights, participate in distributions and 7 8 Exhibit 3.2 to have the benefit of all other rights of holders of Series F Preferred Stock. In lieu of fractional shares, the Corporation, prior to the first issuance of a share or a fraction of a share of Series F Preferred Stock, may elect (1) to make a cash payment as provided in the Rights Agreement for fractions of a share other than one one-thousandths (1/1,000ths) of a share or any integral multiple thereof or (2) to issue depository receipts evidencing such authorized fraction of a share of Series F Preferred Stock pursuant to an appropriate agreement between the Corporation and a depository selected by the Corporation; provided that such agreement shall provide that the holders of such depository receipts shall have all the rights, privileges and preferences to which they are entitled as holders of the Series F Preferred Stock. SECTION 10. Reacquired Shares. Any shares of Series F Preferred Stock purchased or otherwise acquired by the Corporation in any manner whatsoever shall be retired and canceled promptly after the acquisition thereof. All such shares shall upon their cancelation become authorized but unissued shares of Preferred Stock, without designation as to series until such shares are once more designated as part of a particular series by the Board of Directors pursuant to the provisions of Article Fifth of the Certificate of Incorporation. SECTION 11. Amendment. None of the powers, preferences and relative, participating, optional and other special rights of the Series F Preferred Stock as provided herein or in the Certificate of Incorporation shall be amended in any manner which would alter or change the powers, preferences, rights or privileges of the holders of Series F Preferred Stock so as to affect them adversely without the affirmative vote of the holders of at least 66-2/3% of the outstanding shares of Series F Preferred Stock, voting as a separate class; provided, however, that no such amendment approved by the holders of at least 66-2/3% of the outstanding shares of Series F Preferred Stock shall be deemed to apply to the powers, preferences, rights or privileges of any holder of shares of Series F Preferred Stock originally issued upon exercise of the Rights after the time of such approval without the approval of such holder. IN WITNESS WHEREOF, the Corporation has caused this Certificate to be duly executed in its corporate name on this day of July 1995. Alteon Inc. 8 9 Exhibit 3.2 By: /s/ James J. Mauzey ------------------------ Name: James J. Mauzey ------------------------ Title: Chairman and CEO ------------------------ Attest: /s/ Elizabeth O'Dell - ----------------------- Name: Elizabeth O'Dell ---------------- Title: Secretary ---------------- 9 EX-3.8 3 w46067ex3-8.txt CERTIFICATE OF RETIREMENT 1 Exhibit 3.8 CERTIFICATE OF RETIREMENT OF STOCK OF ALTEON INC. Pursuant to Section 243 of the Delaware General Corporation Law, Alteon Inc., a corporation organized and existing under the laws of the State of Delaware (the "Corporation"), DOES HEREBY CERTIFY THAT: 1. The Certificate of Designations of Series G Preferred Stock of the Corporation provides that shares of the Corporation's Series G Preferred Stock (the "Series G Preferred Stock") purchased or otherwise acquired by the Corporation (including upon conversion thereof) shall be retired and canceled after such acquisition and upon such cancellation shall become authorized but unissued shares of the Corporation's Preferred Stock, without designation as to series until such shares are once more designated as part of a particular series by the Board of Directors. 2. 243 shares of the Series G Preferred Stock have been acquired by the Corporation by reason of conversion and have been retired. 3. Pursuant to the Certificate of Designation, the total number of shares of Preferred Stock which the Corporation is authorized to issue is unaffected by this Certificate of Retirement and remains 1,993,329 shares. IN WITNESS WHEREOF, this Certificate of Retirement of Stock is made this 20 day of November 2000. ALTEON INC. By: /s/ Kenneth I. Moch --------------------------- Kenneth I. Moch President and Chief Executive Officer EX-4.1 4 w46067ex4-1.txt STOCKHOLDERS' RIGHTS AGREEMENT 1 Exhibit 4.1 - -------------------------------------------------------------------------------- STOCKHOLDERS RIGHTS AGREEMENT Dated as of July 27, 1995 between ALTEON INC. and Registrar and Transfer Company as Rights Agent - -------------------------------------------------------------------------------- 1 2 Exhibit 4.1 TABLE OF CONTENTS Certain Definitions............................................................1 Appointment of Rights Agent...................................................10 Issue of Rights and Right Certificates........................................10 Form of Right Certificates....................................................11 Execution, Countersignature and Registration..................................12 Transfer, Split-Up, Combination and Exchange of Right Certificates; Mutilated, Destroyed, Lost or Stolen Right Certificates; Uncertificated Rights................................................13 Exercise of Rights; Expiration Date of Rights.................................14 Cancellation and Destruction of Right Certificates............................16 Reservation and Availability of Preferred Shares..............................16 Preferred Shares Record Date..................................................18 Adjustments in Rights After there is an Acquiring Person; Exchange of Rights for Shares; Business Combinations..........................18 Certain Adjustments...........................................................22 Certificate of Adjustment.....................................................24 Additional Covenants..........................................................24 Fractional Rights and Fractional Shares.......................................24 Rights of Action..............................................................25 Transfer and Ownership of Rights and Right Certificates.......................26 Right Certificate Holder Not Deemed a Stockholder.............................26 Concerning the Rights Agent...................................................27 Merger or Consolidation or Change of Rights Agent.............................27 Duties of Rights Agent........................................................28 Change of Rights Agent........................................................31 Issuance of Additional Rights and Right Certificates..........................32 Redemption and Termination....................................................32 Notices.......................................................................33 Supplements and Amendments....................................................34 2 3 Exhibit 4.1 Successors....................................................................34 Benefits of Rights Agreement; Determinations and Actions by the Board of Directors, etc..................................................35 Severability..................................................................35 Governing Law.................................................................36 Counterparts; Effectiveness...................................................36 Descriptive Headings..........................................................36 3 4 Exhibit 4.1 STOCKHOLDERS RIGHTS AGREEMENT (this "Rights Agreement") dated as of July 27, 1995, between ALTEON INC., a Delaware corporation (the "Company"), and Registrar and Transfer Company, as Rights Agent (the "Rights Agent"). The Board of Directors of the Company has authorized and declared a dividend of one Right (as hereinafter defined) for each share of Common Stock, par value $0.01 per share, of the Company (the "Common Stock") outstanding at the Close of Business (as hereinafter defined) on the date fifteen (15) days following the date of this Rights Agreement (the "Record Date"), and has authorized the issuance of one Right (as such number may hereafter be adjusted pursuant to the provisions of this Rights Agreement) with respect to each share of Common Stock that shall become outstanding between the Record Date and the earliest of the Distribution Date, the Redemption Date or the Expiration Date (as such terms are hereinafter defined); provided, however, that Rights may be issued with respect to shares of Common Stock that shall become outstanding after the Distribution Date and prior to the earlier of the Redemption Date or the Expiration Date in accordance with the provisions of Section 23. Each Right shall initially represent the right to purchase one one-thousandths (1/1,000ths) of a share of Series F Preferred Stock, par value $0.01 per share, of the Company (the "Preferred Shares"), having the powers, rights and preferences set forth in the Certificate of Designation attached as Exhibit A. Accordingly, in consideration of the premises and the mutual agreements herein set forth, the parties hereby agree as follows: Section 1. Certain Definitions. For purposes of this Rights Agreement, the following terms have the meanings indicated: "Acquiring Person" shall mean any Person who or which, alone or together with all Affiliates and Associates of such Person, shall be the Beneficial Owner of more than 20% of the Common Shares then outstanding, other than pursuant to a Qualifying Offer, but shall not include (a) the Company, any Subsidiary of the Company, any employee benefit plan of the Company or of any of its Subsidiaries, or any Person holding Common Shares for or pursuant to the terms of any such employee benefit plan or (b) any such Person who has become such a Beneficial Owner solely because (i) of a change in the aggregate number of Common Shares outstanding since the last date on which such Person acquired Beneficial Ownership of any Common Shares or (ii) it acquired such Beneficial Ownership in the good faith belief that such acquisition would not (x) cause such Beneficial Ownership to exceed 20% of the Common Shares then outstanding and such Person relied in good faith in computing the percentage of its Beneficial Ownership on publicly filed reports or documents of the Company which are inaccurate or out-of-date or (y) otherwise cause a Distribution Date or the adjustment provided for in Section 11(a) to occur. Notwithstanding clause (b) of the prior sentence, if any Person that is not an Acquiring Person due to such clause (b) does not reduce its percentage of Beneficial Ownership of Common Shares to 20% or less by the Close of Business on the fifth Business Day after notice from the Company (the date of notice being the first day) that such Person's Beneficial Ownership of Common Shares so exceeds 20%, such Person shall, at the end of such five Business Day period, become an Acquiring Person (and such clause (b) shall no longer apply to such Person). For purposes of this definition, the determination whether any Person acted in "good faith" shall be conclusively determined by the Board of Directors of the Company, acting by a vote of those directors of the Company whose approval would be required to redeem the Rights under Section 24. 1 5 Exhibit 4.1 "Affiliate" and "Associate", when used with reference to any Person, shall have the respective meanings ascribed to such terms in Rule 12b-2 of the General Rules and Regulations under the Exchange Act, as in effect on the date of this Rights Agreement. A Person shall be deemed the "Beneficial Owner" of, and shall be deemed to "beneficially own", and shall be deemed to have "Beneficial Ownership" of, any securities: (i) which such Person or any of such Person's Affiliates or Associates is deemed to "beneficially own" within the meaning of Rule 13d-3 of the General Rules and Regulations under the Exchange Act, as in effect on the date of this Rights Agreement; (ii) which such Person or any of such Person's Affiliates or Associates has (A) the right to acquire (whether such right is exercisable immediately or only after the passage of time) pursuant to any agreement, arrangement or understanding (written or oral), or upon the exercise of conversion rights, exchange rights, rights (other than the Rights), warrants or options, or otherwise; provided, however, that a Person shall not be deemed the Beneficial Owner of, or to beneficially own, or to have Beneficial Ownership of, securities tendered pursuant to a tender or exchange offer made by or on behalf of such Person or any of such Person's Affiliates or Associates until such tendered securities are accepted for purchase or exchange thereunder, or (B) the right to vote pursuant to any agreement, arrangement or understanding (written or oral); provided, however, that a Person shall not be deemed the Beneficial owner of, or to beneficially own, any security if (1) the agreement, arrangement or understanding (written or oral) to vote such security arises solely from a revocable proxy or consent given to such Person in response to a public proxy or consent solicitation made pursuant to, and in accordance with, the applicable rules and regulations under the Exchange Act and (2) the beneficial ownership of such security is not also then reportable on Schedule 13D under the Exchange Act (or any comparable or successor report); or (iii) which are beneficially owned, directly or indirectly, by any other Person with which such Person or any of such Person's Affiliates or Associates has any agreement, arrangement or understanding (written or oral) for the purpose of acquiring, holding, voting (except pursuant to a revocable proxy as described in clause (ii)(B) of this definition) or disposing of any securities of the Company. Notwithstanding the foregoing, nothing contained in this definition shall cause a Person ordinarily engaged in business as an underwriter of securities to be the "Beneficial Owner" of, or to "beneficially own", any securities acquired in a bona fide firm commitment underwriting pursuant to an underwriting agreement with the Company. "Book Value", when used with reference to Common Shares issued by any Person, shall mean the amount of equity of such Person applicable to each Common Share, determined (i) in accordance with generally accepted accounting principles in effect on the date as to which such Book Value is to be determined, (ii) using all the consolidated assets and all the consolidated liabilities of such Person on the date as of which such Book Value is to be determined, except that no value shall be included in such assets for goodwill arising from consummation of a business combination, and (iii) after giving effect to (A) the exercise of all rights, options and warrants to purchase such Common Shares (other than the Rights), and the conversion of all securities convertible into such Common 2 6 Exhibit 4.1 Shares, at an exercise or conversion price, per Common Share, which is less than such Book Value before giving effect to such exercise or conversion (whether or not exercisability or convertibility is conditioned upon occurrence of a future event), (B) all dividends and other distributions on the capital stock of such Person declared prior to the date as of which such Book Value is to be determined and to be paid or made after such date, and (C) any other agreement, arrangement or understanding (written or oral), or transaction or other action prior to the date as of which such Book Value is to be determined which would have the effect of thereafter reducing such Book Value. "Business Combination" shall have the meaning set forth in Section 11(c)(I). "Business Day" shall mean each Monday, Tuesday, Wednesday, Thursday and Friday which is not a day on which banking institutions in the Borough of Manhattan, the City of New York, are authorized or obligated by law or executive order to close. "Certificate of Designation" shall mean the Certification of Designation of Series F Preferred Stock setting forth the powers, preferences, rights, qualifications, limitations and restrictions of such series of Preferred Stock of the Company, a copy of which is attached as Exhibit A. "Close of Business" on any given date shall mean 5:00 p.m., New York City time, on such date; provided, however, that, if such date is not a Business Day, "Close of Business" shall mean 5:00 p.m., New York City time, on the next succeeding Business Day. "Common Shares", when used with reference to the Company prior to a Business Combination, shall mean the shares of Common Stock of the Company or any other shares of capital stock of the Company into which the Common Stock shall be reclassified or changed. "Common Shares", when used with reference to any Person (other than the Company prior to a Business Combination), shall mean shares of capital stock of such Person (if such Person is a corporation) of any class or series, or units of equity interests in such Person (if such Person is not a corporation) of any class or series, the terms of which do not limit (as a maximum amount and not merely in proportional terms) the amount of dividends or income payable or distributable on such class or series or the amount of assets distributable on such class or series upon any voluntary or involuntary liquidation, dissolution or winding up of such Person and do not provide that such class or series is subject to redemption at the option of such Person, or any shares of capital stock or units of equity interests into which the foregoing shall be reclassified or changed; provided, however, that, if any time there shall be more than one such class or series of capital stock or equity interests of such Person, "Common Shares" of such Person shall include all such classes and series substantially in the proportion of the total number of shares or other units of each such class or series outstanding at such time. "Common Stock" shall have the meaning set forth in the introductory paragraph of this Rights Agreement. "Company" shall have the meaning set forth in the heading of this Rights Agreement; provided, however, that if there is a Business Combination, "Company" shall have the meaning set forth in Section 11(c)(III). The term "control" with respect to any Person shall mean the power to direct the management and policies of such Person, directly or indirectly, by or 3 7 Exhibit 4.1 through stock ownership, agency or otherwise, or pursuant to or in connection with an agreement, arrangement or understanding (written or oral) with one or more other Persons by or through stock ownership, agency or otherwise; and the terms "controlling" and "controlled" shall have meanings correlative to the foregoing. "Distribution Date" shall have the meaning set forth in Section 3(b). "Exchange Act" shall mean the Securities Exchange Act of 1934, as in effect on the date in question, unless otherwise specifically provided. "Exchange Consideration" shall have the meaning set forth in Section 11(b)(I). "Expiration Date" shall have the meaning set forth in Section 7(a). "Major Part," when used with reference to the assets of the Company and its Subsidiaries as of any date, shall mean assets (i) having a fair market value aggregating 50% or more of the total fair market value of all the assets of the Company and its Subsidiaries (taken as a whole) as of the date in question, (ii) accounting for 50% or more of the total value (net of depreciation and amortization) of all the assets of the Company and its Subsidiaries (taken as a whole) as would be shown on a consolidated or combined balance sheet of the Company and its Subsidiaries as of the date in question, prepared in accordance with generally accepted accounting principles then in effect, or (iii) accounting for 50% or more of the total amount of earnings before interest, taxes, depreciation and amortization or revenues of the Company and its Subsidiaries (taken as a whole) as would be shown on, or derived from, a consolidated or combined statement of income of the Company and its Subsidiaries for the period of 12 months ending on the last day of the Company's monthly accounting period next preceding the date in question, prepared in accordance with generally accepted accounting principles then in effect. "Market Value," when used with reference to Common Shares on any date, shall be deemed to be the average of the daily closing prices, per share, of such Common Shares for the period which is the shorter of (1) 30 consecutive Trading Days immediately prior to the date in question or (2) the number of consecutive Trading Days beginning on the Trading Day immediately after the date of the first public announcement of the event requiring a determination of the Market Value and ending on the Trading Day immediately prior to the record date of such event; provided, however, that, in the event that the Market Value of such Common Shares is to be determined in whole or in part during a period following the announcement by the issuer of such Common Shares of any action of the type described in Section 12(a) that would require an adjustment thereunder, then, and in each such case, the Market Value of such Common Shares shall be appropriately adjusted to reflect the effect of such action on the market price of such Common Shares. The closing price for each Trading Day shall be the closing price quoted on the composite tape for securities listed on the New York Stock Exchange, or, if such securities are not quoted on such composite tape or if such securities are not listed on such exchange, on the principal United States securities exchange registered under the Exchange Act (or any recognized foreign stock exchange) on which such securities are listed, or, if such securities are not listed on any such exchange, the average of the closing bid and asked quotations with respect to a share of such securities on the National Association of Securities Dealers, Inc. Automated Quotations System ("NASDAQ") or such other system then in use, or if no such quotations are available, the average of the closing bid and asked prices as furnished by a professional market maker making a market in such securities selected by the Board of Directors of 4 8 Exhibit 4.1 the Company. If on any such Trading Day no market maker is making a market in such securities, the closing price of such securities on such Trading Day shall be deemed to be the fair value of such securities as determined in good faith by the Board of Directors of the Company (whose determination shall be described in a statement filed with the Rights Agent and shall be binding on the Rights Agent, the holders of Rights and all other Persons); provided, however, that for the purpose of determining the closing price of the Preferred Shares for any Trading Day on which there is no such market maker for the Preferred Shares the closing price on such Trading Day shall be deemed to be the Formula Number (as defined in the Certificate of Designation) times the closing price of the Common Shares of the Company on such Trading Day. "Person" shall mean an individual, corporation, partnership, joint venture, association, trust, unincorporated organization or other entity. "Preferred Shares" shall have the meaning set forth in the introductory paragraph of this Rights Agreement. Any reference in this Rights Agreement to Preferred Shares shall be deemed to include any authorized fraction of a Preferred Share, unless the context otherwise requires. "Principal Party" shall mean the Surviving Person in a Business Combination; provided, however, that, if such Surviving Person is a direct or indirect Subsidiary of any other Person, "Principal Party" shall mean the Person which is the ultimate parent of such Surviving Person and which is not itself a Subsidiary of another Person. In the event ultimate control of such Surviving Person is shared by two or more Persons, "Principal Party" shall mean that Person that is immediately controlled by such two or more Persons. "Purchase Price" with respect to each Right shall mean $80.00, as such amount may from time to time be adjusted as provided herein, and shall be payable in lawful money of the United States of America. All references herein to the Purchase Price shall mean the Purchase Price as in effect at the time in question. "Qualifying Offer" shall mean an all-cash tender offer made by any Person for all outstanding Common Shares which meets all of the following requirements: (1) on or prior to the date such offer is commenced within the meaning of Rule 14d-2(a) of the General Rules and Regulations under the Exchange Act, such Person has, and has provided to the Company, firm written commitments from responsible financial institutions, which have been accepted by such Person (or one of its Affiliates), to provide, subject only to customary terms and conditions, funds for such offer which, when added to the amount of cash and cash equivalents which such Person then has available and has irrevocably committed in writing to the Company to utilize for purposes of such offer, will be sufficient to pay for all Common Shares outstanding on a fully diluted basis pursuant to the offer and the second-step transaction required by clause (6) below and all related expenses, together with copies of all written materials prepared by such person for such financial institutions in connection with obtaining such financing commitments; (2) after the consummation of such offer, such Person, alone or together with any of its Affiliates and Associates, owns Common Shares representing a majority of the then outstanding Common Shares; 5 9 Exhibit 4.1 (3) such offer remains open for at least 45 Business Days; provided, however, that (x) if there is any increase in the price of such offer, such offer must remain open for at least an additional 20 Business Days after the last such increase, (y) such offer must remain open for at least 20 Business Days after the date that any bona fide alternative offer is made which, in the opinion of one or more investment banking firms designated by the Company, provides for consideration per share in excess of that provided for in such offer, and (z) such offer must remain open for at least 20 Business Days after the date on which such Person reduces the per share price offered in accordance with clause (6)(y) below; provided further, however, that such offer need not remain open, as a result of this clause (3), beyond (i) the time which any other offer satisfying the criteria for a Qualifying Offer is then required to be kept open under this clause (3), or (ii) the scheduled expiration date, as such date may be extended by public announcement on or prior to the then scheduled expiration date, of any other tender or exchange offer for Common Shares with respect to which the Board of Directors has agreed to redeem the Rights immediately prior to acceptance for payment of Common Shares thereunder (unless such other offer is terminated prior to its expiration without any Common Shares having been purchased thereunder); (4) such offer is accompanied by a written opinion, in customary form, of a nationally recognized investment banking firm which is addressed to the holders of Common Shares other than such Person and states that the price to be paid to holders pursuant to the offer is fair from a financial point of view to such holders and includes any written presentation of such firm showing the analysis and range of values underlying such conclusions; (5) such offer is approved by a majority of the Board of Directors of the Company who are not officers of the Company and who are not nominees, Affiliates or Associates of such Person, after determining that the price to be paid to stockholders pursuant to the offer is the best value reasonably available to stockholders after taking into account the potential long-term value of the Company and all other factors that it considers relevant or otherwise in the best interest of the stockholders; and (6) prior to or on the date that such offer is commenced within the meaning of Rule 14d-2(a) of the General Rules and Regulations under the Exchange Act, such Person makes an irrevocable written commitment to the Company (x) to consummate a transaction or transactions promptly upon the completion of such offer, whereby all Common Shares not purchased in such offer will be acquired at the same price per share paid in such offer, subject only to the condition that the Board of Directors shall have granted any approvals required to enable such Person to consummate such transaction or transactions following consummation of such offer without obtaining the vote of any other stockholder, (y) that such Person will not make any amendment to the original offer which reduces the per share price offered (other than a reduction to reflect any dividend declared by the Company after the commencement of such offer, whether by way of recapitalization, reorganization, repurchase or otherwise), changes the form of consideration offered, or reduces the number of shares being sought or which is in any other respect materially adverse to the Company's stockholders, and (z) that neither such Person nor of any its Affiliates or Associates will make any offer for any equity securities of the Company for a period of six months after the commencement of the original offer if such original offer does not result in the tender of the 6 10 Exhibit 4.1 number of Common Shares required to be purchased pursuant to clause (2) above, unless another tender offer by another party for all outstanding Common Shares is commenced that (a) constitutes a Qualifying Offer or (b) is approved by the Board of Directors of the Company (in which event, any new offer by such Person or of any of its Affiliates or Associates must be at a price no less than that provided for in such approved offer). "Record Date" shall have the meaning set forth in the introductory paragraph of this Rights Agreement. "Redemption Date" shall have the meaning set forth in Section 24(a). "Redemption Price" with respect to each Right shall mean $.01, as such amount may from time to time be adjusted in accordance with Section 12. All references herein to the Redemption Price shall mean the Redemption Price as in effect at the time in question. "Registered Common Shares" shall mean Common Shares which are, as of the date of consummation of a Business Combination, and have continuously been for the 12 months immediately preceding such date, registered under Section 12 of the Exchange Act. "Right Certificate" shall mean a certificate evidencing a Right in substantially the form attached as Exhibit B. "Rights" shall mean the rights to purchase Preferred Shares (or other securities) as provided in this Rights Agreement. "Securities Act" shall mean the Securities Act of 1933, as in effect on the date in question, unless otherwise specifically provided. "Subsidiary" shall mean a Person, at least a majority of the total outstanding voting power (being the power under ordinary circumstances (and not merely upon the happening of a contingency) to vote in the election of directors of such Person (if such Person is a corporation) or to participate in the management and control of such Person (if such Person is not a corporation)) of which is owned, directly or indirectly, by another Person or by one or more other Subsidiaries of such other Person or by such other Person and one or more other Subsidiaries of such other Person. "Surviving Person" shall mean (1) the Person which is the continuing or surviving Person in a consolidation or merger specified in Section 11(c)(I)(i) or 11(c)(I)(ii) or (2) the Person to which the Major Part of the assets of the Company and its Subsidiaries is sold, leased, exchanged or otherwise transferred or disposed of in a transaction specified in Section 11(c)(I)(iii); provided, however, that if the Major Part of the assets of the Company and its Subsidiaries is sold, leased, exchanged or otherwise transferred or disposed of in one or more related transactions specified in Section 11(c)(I)(iii) to more than one Person, the "Surviving Person" in such case shall mean the Person that acquired assets of the Company and/or its Subsidiaries with the greatest fair market value in such transaction or transactions. "Trading Day" shall mean a day on which the principal national securities exchange (or principal recognized foreign stock exchange, as the case may be) on which any securities or Rights, as the case may be, are listed or admitted to trading is open for the transaction of business or, if the securities or Rights in question are not listed or admitted to trading on any national 7 11 Exhibit 4.1 securities exchange (or recognized foreign stock exchange, as the case may be), a Business Day. SECTION 2. Appointment of Rights Agent. The Company hereby appoints the Rights Agent to act as agent for the Company in accordance with the terms and conditions hereof, and the Rights Agent hereby accepts such appointment. The Company may from time to time appoint one or more co-Rights Agents as it may deem necessary or desirable (the term "Rights Agent" being used herein to refer, collectively, to the Rights Agent together with any such co-Rights Agents). In the event the Company appoints one or more co-Rights Agents, the respective duties of the Rights Agent and any co-Rights Agents shall be as the Company shall determine. SECTION 3. Issue of Rights and Right Certificates. (a) One Right shall be associated with each Common Share outstanding on the Record Date, each additional Common Share that shall become outstanding between the Record Date and the earliest of the Distribution Date, the Redemption Date or the Expiration Date and each additional Common Share with which Rights are issued after the Distribution Date but prior to the earlier of the Redemption Date or the Expiration Date as provided in Section 23; provided, however, that, if the number of outstanding Rights are combined into a smaller number of outstanding Rights pursuant to Section 12(a), the appropriate fractional Right determined pursuant to such Section shall thereafter be associated with each such Common Share. (b) Until the earlier of (i) such time as the Company learns that a Person has become an Acquiring Person or (ii) the Close of Business on such date, if any, as may be designated by the Board of Directors of the Company following the commencement of, or first public disclosure of an intent to commence, a tender or exchange offer by any Person (other than the Company, any Subsidiary of the Company, any employee benefit plan of the Company or of any of its Subsidiaries, or any Person holding Common Shares for or pursuant to the terms of any such employee benefit plan and other than a Qualifying Offer) for outstanding Common Shares, if upon consummation of such tender or exchange offer such Person could be the Beneficial Owner of more than 20% of the outstanding Common Shares (the Close of Business on the earlier of such dates being the "Distribution Date"), (x) the Rights will be evidenced by the certificates for Common Shares registered in the names of the holders thereof and not by separate Right Certificates and (y) the Rights, including the right to receive Right Certificates, will be transferable only in connection with the transfer of Common Shares. As soon as practicable after the Distribution Date, the Rights Agent will send, by first-class, postage-prepaid mail, to each record holder of Common Shares as of the Distribution Date, at the address of such holder shown on the records of the Company, a Right Certificate evidencing one whole Right for each Common Share (or for the number of Common Shares with which one whole Right is then associated if the number of Rights per Common Share held by such record holder has been adjusted in accordance with the proviso in Section 3(a)). If the number of Rights associated with each Common Share has been adjusted in accordance with the proviso in Section 3(a), at the time of distribution of the Right Certificates the Company may make any necessary and appropriate rounding adjustments so that Right Certificates representing only whole numbers of Rights are distributed and cash is paid in lieu of any fractional Right in accordance with Section 15(a). As of and after the Distribution Date, the Rights will be evidenced solely by such Right Certificates. (c) With respect to any certificate for Common Shares, until the earliest of the Distribution Date, the Redemption Date or the Expiration Date, the Rights associated with the Common Shares represented by any such certificate 8 12 Exhibit 4.1 shall be evidenced by such certificate alone, the registered holders of the Common Shares shall also be the registered holders of the associated Rights and the surrender for transfer of any such certificate shall also constitute the transfer of the Rights associated with the Common Shares represented thereby. (d) Certificates issued for Common Shares after the Record Date (including, without limitation, upon transfer or exchange of outstanding Common Shares), but prior to the earliest of the Distribution Date, the Redemption Date or the Expiration Date, may have printed on, written on or otherwise affixed to them the following legend: This certificate also evidences and entitles the holder hereof to certain Rights as set forth in a Stockholders Rights Agreement dated as of July 27, 1995, as it may be amended from time to time (the "Rights Agreement"), between Alteon Inc. (the "Company") and Registrar and Transfer Company, as Rights Agent (the "Rights Agent"), the terms of which are hereby incorporated herein by reference and a copy of which is on file at the principal executive offices of the Company. Under certain circumstances, as set forth in the Rights Agreement, such Rights will be evidenced by separate certificates and will no longer be evidenced by this certificate. The Rights Agent will mail to the holder of this certificate a copy of the Rights Agreement without charge after receipt of a written request therefor. Rights beneficially owned by Acquiring Persons or their Affiliates or Associates (as such terms are defined in the Rights Agreement) and by any subsequent holder of such Rights are null and void and nontransferable. Notwithstanding this paragraph (d), the omission of a legend shall not affect the enforceability of any part of this Rights Agreement or the rights of any holder of Rights. SECTION 4. Form of Right Certificates. The Right Certificates (and the form of election to purchase and form of assignment to be printed on the reverse side thereof) shall be in substantially the form set forth as Exhibit B and may have such marks of identification or designation and such legends, summaries or endorsements printed thereon as the Company may deem appropriate and as are not inconsistent with the provisions of this Rights Agreement, or as may be required to comply with any applicable law or with any rule or regulation made pursuant thereto or with any rule or regulation of any stock exchange on which the Rights may from time to time be listed, or to conform to usage. Subject to the provisions of Sections 7, 11 and 23, the Right Certificates, whenever issued, shall be dated as of the Distribution Date, and on their face shall entitle the holders thereof to purchase such number of Preferred Shares as shall be set forth therein for the Purchase Price set forth therein, subject to adjustment from time to time as herein provided. SECTION 5. Execution, Countersignature and Registration. (a) The Right Certificates shall be executed on behalf of the Company by the Chairman of the Board, the Chief Executive Officer, the President, the Chief Operating Officer, the Treasurer or a Vice President (whether preceded by any additional title) of the Company, either manually or by facsimile signature, and have affixed thereto the Company's seal or a facsimile thereof which shall be attested by the Secretary, an Assistant Secretary or a Vice President (whether preceded by any additional title, provided that such Vice President shall not have also executed the Right Certificates) of the Company, 9 13 Exhibit 4.1 either manually or by facsimile signature. The Right Certificates shall be manually countersigned by the Rights Agent and shall not be valid or obligatory for any purpose unless so countersigned. In case any officer of the Company who shall have signed any of the Right Certificates shall cease to be such an officer of the Company before countersignature by the Rights Agent and issuance and delivery by the Company, such Right Certificates may nevertheless be countersigned by the Rights Agent and issued and delivered by the Company with the same force and effect as though the person who signed such Right Certificates had not ceased to be such an officer of the Company; and any Right Certificate may be signed on behalf of the Company by any person who, at the actual date of execution of such Right Certificate, shall be a proper officer of the Company to sign such Right Certificate, although at the date of execution of this Rights Agreement any such person was not such an officer of the Company. (b) Following the Distribution Date, the Rights Agent will keep or cause to be kept, at its principal office in Cranford, New Jersey, books for registration and transfer of the Right Certificates issued hereunder. Such books shall show the names and addresses of the respective holders of the Right Certificates, the number of Rights evidenced by each of the Right Certificates, the certificate number of each of the Right Certificates and the date of each of the Right Certificates. SECTION 6. Transfer, Split-Up, Combination and Exchange of Right Certificates; Mutilated, Destroyed, Lost or Stolen Right Certificates; Uncertificated Rights. (a) Subject to the provisions of Sections 7(e) and 15, at any time after the Distribution Date, and at or prior to the Close of Business on the earlier of the Redemption Date or the Expiration Date, any Right Certificate or Right Certificates may be transferred, split-up, combined or exchanged for another Right Certificate or Right Certificates representing, in the aggregate, the same number of Rights as the Right Certificate or Right Certificates surrendered then represented. Any registered holder desiring to transfer, split-up, combine or exchange any Right Certificate shall make such request in writing delivered to the Rights Agent and shall surrender the Right Certificate or Right Certificates to be transferred, split-up, combined or exchanged at the principal office of the Rights Agent; provided, however, that neither the Rights Agent nor the Company shall be obligated to take any action whatsoever with respect to the transfer of any Right Certificate surrendered for transfer until the registered holder shall have completed and signed the certification contained in the form of assignment on the reverse side of such Right Certificate and shall have provided such additional evidence of the identity of the Beneficial Owner (or former Beneficial Owner) or Affiliates or Associates thereof as the Company shall reasonably request. Thereupon the Rights Agent shall, subject to Sections 7(e) and 15, countersign and deliver to the Person entitled thereto a Right Certificate or Right Certificates, as the case may be, as so requested. The Company may require payment of a sum sufficient to cover any tax or governmental charge that may be imposed in connection with any transfer, split-up, combination or exchange or Right Certificates. (b) Upon receipt by the Company and the Rights Agent of evidence reasonable satisfactory to them of the loss, theft, destruction or mutilation of a valid Right Certificate, and, in case of loss, theft or destruction, of indemnity or security reasonably satisfactory to them, and, at the Company's request, reimbursement to the Company and the Rights Agent of all reasonable expenses incidental thereto, and upon surrender to the Rights Agent and cancellation of the Right Certificate if mutilated, the Company will make a new 10 14 Exhibit 4.1 Right Certificate of like tenor and deliver such new Right Certificate to the Rights Agent for delivery to the registered owner in lieu of the Right Certificate so lost, stolen, destroyed or mutilated. (c) Notwithstanding any other provision hereof, the Company and the Rights Agent may amend this Rights Agreement to provide for uncertificated Rights in addition to or in place of Rights evidenced by Right Certificates. 11 15 Exhibit 4.1 SECTION 7. Exercise of Rights; Expiration Date of Rights. (a) Subject to Section 7(e) and except as otherwise provided herein (including Section 11), each Right shall entitle the registered holder thereof, upon exercise thereof as provided herein, to purchase for the Purchase Price, at any time after the Distribution Date and at or prior to the earlier of (i) the Close of Business on the 10th anniversary of the date of this Rights Agreement (the Close of Business on such date being the "Expiration Date"), or (ii) the Redemption Date, one one-thousandths (1/1,000ths) of a Preferred Share, subject to adjustment from time to time as provided in Sections 11 and 12. (b) The registered holder of any Right Certificate may exercise the Rights evidenced thereby (except as otherwise provided herein) in whole or in part at any time after the Distribution Date, upon surrender of the Right Certificate, with the form of election to purchase on the reverse side thereof duly executed, to the Rights Agent at the principal office of the Rights Agent in New York, New York, together with payment of the Purchase price for each one one-thousandths (1/1,000ths) of a Preferred Share as to which the Rights are exercised, at or prior to the earlier of (i) the Expiration Date or (ii) the Redemption Date. (c) Upon receipt of a Right Certificate representing exercisable Rights, with the form of election to purchase duly executed, accompanied by payment of the Purchase Price for the Preferred Shares to be purchased together with an amount equal to any applicable transfer tax, in lawful money of the United States of America, in cash or by certified check or money order payable to the order of the Company, the Rights Agent shall thereupon (i) either (A) promptly requisition from any transfer agent of the Preferred Shares (or make available, if the Rights Agent is the transfer agent) certificates for the number of Preferred Shares to be purchased and the Company hereby irrevocably authorizes its transfer agent to comply with all such requests or (B) if the Company shall have elected to deposit the Preferred Shares with a depositary agent under the depositary arrangement, promptly requisition from the depositary agent depositary receipts representing the number of one one-thousandths (1/1,000ths) of a Preferred Share to be purchased (in which case certificates for the Preferred Shares to be represented by such receipts shall be deposited by the transfer agent with the depositary agent) and the Company will direct the depositary agent to comply with all such requests, (ii) when appropriate, promptly requisition from the Company the amount of cash to be paid in lieu of issuance of fractional shares in accordance with Section 15, (iii) promptly after receipt of such certificates or depositary receipts, cause the same to be delivered to or upon the order of the registered holder of such Right Certificate, registered in such name or names as may be designated by such holder and (iv) when appropriate, after receipt promptly deliver such cash to or upon the order of the registered holder of such Right Certificate. (d) In case the registered holder of any right Certificate shall exercise fewer than all the Rights evidenced thereby, a new Right Certificate evidencing Rights equivalent to the Rights remaining unexercised shall be issued by the Rights Agent and delivered to the registered holder of such Right Certificate or to his duly authorized assigns, subject to the provisions of Section 15. (e) Notwithstanding anything in this Rights Agreement to the contrary, any Rights that are at any time beneficially owned by an Acquiring Person or any Affiliate or Associate of an Acquiring Person shall be null and void and nontransferable, and any holder of any such Right (including any 12 16 Exhibit 4.1 purported transferee or subsequent holder) shall not have any right to exercise or transfer any such Right. (f) Notwithstanding anything in this Rights Agreement to the contrary, neither the Rights Agent nor the Company shall be obligated to undertake any action with respect to a registered holder of any Right Certificates upon the occurrence of any purported exercise as set forth in this Section 7 unless such registered holder shall have (i) completed and signed the certificate contained in the form of election to purchase set forth on the reverse side of the Right Certificate surrendered for such exercise and (ii) provided such additional evidence of the identity of the Beneficial Owner (or former Beneficial owner) or Affiliates or Associates thereof as the Company shall reasonably request. (g) The Company may temporarily suspend, for a period of time not to exceed 90 calendar days after the Distribution Date, the exercisability of the Rights in order to prepare and file a registration statement under the Securities Act, on appropriate form, with respect to the Preferred Shares purchasable upon exercise of the Rights and permit such registration statement to become effective; provided, however, that no such suspension shall remain effective after, and the Rights shall without any further action by the Company or any other Person become exercisable immediately upon, the effectiveness of such registration statement. Upon any such suspension, the Company shall issue a public announcement stating that the exercisability of the Rights has been temporarily suspended and shall issue a further public announcement at such time as the suspension is no longer in effect. Notwithstanding any provision herein to the contrary, the Rights shall not be exercisable in any jurisdiction if the requisite qualification under the blue sky or securities laws of such jurisdiction shall not have been obtained or the exercise of the Rights shall not be permitted under applicable law. SECTION 8. Cancellation and Destruction of Right Certificates. All Right Certificates surrendered or presented for the purpose of exercise, transfer, split-up, combination or exchange shall, and any Right Certificate representing Rights that have become null and void and nontransferable pursuant to Section 7(e) surrendered or presented for any purpose shall, if surrendered or presented to the Company or to any of its agents, be delivered to the Rights Agent for cancellation or in canceled form, or, if surrendered or presented to the Rights Agent, for cancellation and retirement, and the Rights Agent for cancellation and retirement, and the Rights Agent shall be canceled by it, and no Right Certificates shall be issued in lieu thereof except as expressly permitted by this Rights Agreement. The Company shall deliver to the Rights Agent shall so cancel and retire, any Right Certificate purchased or acquired by the Company. The Rights Agent shall deliver all canceled Right Certificates to the Company, or shall, at the written request of the Company, destroy such canceled Right Certificates, and in such case shall deliver a certificate of destruction thereof to the Company. SECTION 9. Reservation and Availability of Preferred Shares. (a) The Company covenants and agrees that it will cause to be reserved and kept available out of its authorized and unissued Preferred shares or any authorized and issued Preferred Shares held in its treasury, free from preemptive rights or any right of first refusal, a number of Preferred Shares sufficient to permit the exercise in full of all outstanding Rights. 13 17 Exhibit 4.1 (b) In the event that there shall not be sufficient Preferred Shares issued but not outstanding or authorized but unissued to permit the exercise or exchange or Rights in accordance with Section 11, the Company covenants and agrees that it will take all such action as may be necessary to authorize additional Preferred Shares for issuance upon the exercise or exchange of Rights pursuant to Section 11; provided, however, that if the Company is unable to cause the authorization of additional Preferred Shares, then the Company shall, or in lieu of seeking any such authorization, the Company may, to the extent necessary and permitted by applicable law and any agreements or instruments in effect prior to the Distribution Date to which it is a party, (A) upon surrender of a Right, pay cash equal to the Purchase Price in lieu of issuing Preferred Shares and requiring payment therefor, (B) upon due exercise of a Right and payment of the Purchase Price for each Preferred Share as to which such Right is exercised, issue equity securities having a value equal to the value of the Preferred Shares which otherwise would have been issuable pursuant to Section 11, which value shall be determined by a nationally recognized investment banking firm selected by the Board or (C) upon due exercise of a Right and payment of the Purchase Price for each Preferred Share as to which such Right is exercised, distribute a combination of Preferred Shares, case and/or other equity and/or debt securities having an aggregate value equal to the value of the Preferred Shares which otherwise would have been issuable pursuant to Section 11, which value shall be determined by a nationally recognized investment banking firm selected by the Board. To the extent that any legal or contractual restrictions (pursuant to agreements or instruments in effect prior to the Distribution Date to which it is a party) prevent the Company from paying the full amount payable in accordance with the forgoing sentence, the Company shall pay to holders of the Rights as to which such payments are being made all amounts which are not then restricted on a pro rata basis as such payments become permissible under such legal or contractual restrictions until such payments have been paid in full. (c) The Company covenants and agrees that it will take all such action as may be necessary to ensure that all Preferred Shares delivered upon exercise or exchange of Rights shall, at the time of delivery of the certificates for such preferred Shares (subject to payment of the Purchase Price), be duly and validly authorized and issued and fully paid and nonassessable shares. (d) So long as the Preferred Shares issuable upon the exercise or exchange of Rights are to be listed on any national securities exchange, the Company covenants and agrees to use its best efforts to cause, from and after such time as the Rights become exercisable or exchangeable, all Preferred Shares reserved for such issuance to be listed on such securities exchange upon official notice of issuance upon such exercise or exchange. (e) The Company further covenants and agrees that it will pay when due and payable any and all Federal and state transfer taxes and charges which may be payable in respect of the issuance or delivery of Right Certificates or of any Preferred Shares or Common Shares or other securities upon the exercise or exchange of the Rights. The Company shall not, however, be required to pay any transfer tax which may be payable in respect of any transfer or delivery of Right Certificates to a Person other than, or in respect of the issuance or delivery of certificates for the Preferred Shares or Common Shares or other securities, as the case may be, in a name other than that of, the registered holder of the Right Certificate evidencing Rights surrendered for exercise or exchange or to issue or deliver any certificates for Preferred Shares or Common Shares or other securities, as the case may be, upon the exercise or exchange of any Rights until any such tax shall have been paid (any such tax being payable by the holder of 14 18 Exhibit 4.1 such Right Certificate at the time of surrender) or until it has been established to the Company's satisfaction that no such tax is due. SECTION 10. Preferred Shares Record Date. Each Person in whose name any certificate for Preferred Shares or Common Shares or other securities is issued upon the exercise or exchange of Rights shall for all purposes be deemed to have become the holder of record of the Preferred Shares or Common Shares or other securities, as the case may be, represented thereby on, and such certificate shall be dated, the date upon which the Right Certificate evidencing such Rights was duly surrendered and payment of any Purchase Price (and any applicable transfer taxes) was made; provided, however, that, if the date of such surrender and payment is a date upon which the transfer books of the Company for the Preferred Shares or Common Shares or other securities, as the case may be, are closed, such Person shall be deemed to have become the record holder of such Preferred Shares or Common Shares or other securities, as the case may be, on, and such certificate shall be dated, the next succeeding Business Day on which the transfer books of the Company for the Preferred Shares or Common Shares or other securities, as the case may be, are open. SECTION 11. Adjustments in Rights After there is an Acquiring Person; Exchange of Rights for Shares; Business Combinations. (a) Upon a Person becoming an Acquiring Person, proper provision shall be made so that each holder of a Right, except as provided in Section 7(e), shall thereafter have a right to receive, upon exercise thereof for the Purchase Price in accordance with the terms of this Rights Agreement, such number of one one-thousandths (1/1,000ths) of a Preferred Share as shall equal the result obtained by multiplying the Purchase Price by a fraction, the numerator of which is the number of one one-thousandths (1/1,000ths) of a Preferred Share for which a Right is then exercisable and the denominator of which is 50% of the market Value of the Common Shares on the date on which a Person becomes an Acquiring Person. As soon as practicable after a Person becomes an Acquiring Person (provided the Company shall not have elected to make the exchange permitted by Section 11(b)(I) for all outstanding Rights), the Company covenants and agrees to use its best efforts to: (I) prepare and file a registration statement under the Securities Act, on an appropriate form, with respect to the Preferred Shares purchasable upon exercise of the Rights; (II) cause such registration statement to become effective as soon as practicable after such filing; (III) cause such registration statement to remain effective (with a prospectus at all times meeting the requirements of the Securities Act) until the Expiration Date; and (IV) qualify or register the Preferred Shares purchasable upon exercise of the Rights under the blue sky or securities laws of such jurisdictions as may be necessary or appropriate. (b) (I) The Board of Directors of the Company may, at its option, at any time after a Person becomes an Acquiring Person, mandatorily exchange all or part of the then outstanding and exercisable Rights (which shall not include Rights that shall have become null and void and nontransferable pursuant to the provisions of Section 7(e)) for consideration per Right consisting of one-half of the securities that would be issuable at such time upon the exercise of one Right 15 19 Exhibit 4.1 in accordance with Section 11(a) or, if applicable, Section 9(b) (the consideration issuable per Right pursuant to this Section 11(b)(I) being the "Exchange Consideration"). The Board of Directors of the Company may, at its option, issue, in substitution for Preferred Shares, Common Shares in an amount per Preferred Share equal to the Formula Number (as defined in the Certificate of Designation) if there are sufficient Common Shares issued but not outstanding or authorized but unissued. If the Board of Directors of the Company elects to exchange all the Rights for Exchange Consideration pursuant to this Section 11(b)(I) prior to the physical distribution of the Rights Certificates, the Corporation may distribute the Exchange Consideration in lieu of distributing Right Certificates, in which case for purposes of this Rights Agreement holders of Rights shall be deemed to have simultaneously received and surrendered for exchange Right Certificates on the date of such distribution. (II) Any action of the Board of Directors of the Company ordering the exchange of any Rights pursuant to Section 11(b)(I) shall be irrevocable and, immediately upon the taking of such action and without any further action and without any notice, the right to exercise any such Right pursuant to Section 11(a) shall terminate and the only right thereafter of a holder of such Right shall be to receive the Exchange Consideration in exchange for each such Right held by such holder or, if the Exchange Consideration shall not have been paid or issued, to exercise any such Right pursuant to Section 11 (c)(I). The Company shall promptly give public notice of any such exchange; provided, however, that the failure to give, or any defect in, such notice shall not affect the validity of such exchange. The Company promptly shall mail a notice of any such exchange to all holders of such Rights at their last addresses as they appear upon the registry books of the Rights Agent. Any notice which is mailed in the manner herein provided shall be deemed given, whether or not the holder receives the notice. Each such notice of exchange will state the method by which the exchange of the Rights for the Exchange Consideration will be effected and, in the event of any partial exchange, the number of Rights which will be exchanged. Any partial exchange shall be effected pro rata based on the number of Rights (other than Rights which shall have become null and void and nontransferable pursuant to the provisions of Section 7(e)) held by each holder of Rights. (c) (I) In the event that, following a Distribution Date, directly or indirectly, any transactions specified in the following clause (i), (ii) or (iii) of this Section 11(c) (each such transaction being a "Business Combination") shall be consummated: (i) the Company shall consolidate with, or merge with and into, any Acquiring Person or any Affiliate or Associate of an Acquiring Person; (ii) any Acquiring Person or any Affiliate or Associate of an Acquiring Person shall merge with and into the Company and, in connection with such merger, all or part of the Common Shares shall be changed into or exchanged for capital stock or other securities of the Company or of any Acquiring Person or Affiliate or Associate of an Acquiring Person or cash or any other property; or (iii) the Company shall sell, lease, exchange or otherwise transfer or dispose of (or one or more of its Subsidiaries shall sell, lease, exchange or otherwise transfer or dispose of), in one or more transactions, the Major Part of the assets of the Company and its Subsidiaries (taken as a whole) to any Acquiring Person or any Affiliate or Associate of an Acquiring Person, then, in each case, proper provision shall be made so that each holder of a Right, except as provided in Section 7(e), shall thereafter have the right to receive, upon the 16 20 Exhibit 4.1 exercise thereof for the Purchase Price in accordance with the terms of this Rights Agreement, the securities specified below (or, at such holder's option, the securities specified in Section 11(a)): (A) If the Principal Party in such Business Combination has Registered Common Shares outstanding, each Right shall thereafter represent the right to receive, upon the exercise thereof for the Purchase Price in accordance with the terms of this Rights Agreement, such number of Registered Common Shares of such Principal Party, free and clear of all liens, encumbrances or other adverse claims, as shall have an aggregate Market Value equal to the result obtained by multiplying the Purchase Price by two; (B) If the Principal Party involved in such Business Combination does not have Registered Common Shares outstanding, each Right shall thereafter represent the right to receive, upon the exercise thereof for the Purchase Price in accordance with the terms of this Rights Agreement, at the election of the holder of such Right at the time of the exercise thereof, any of: (1) such number of Common Shares of the Surviving Person in such Business Combination as shall have an aggregate Book Value immediately after giving effect to such Business Combination equal to the result obtained by multiplying the Purchase Price by two; (2) such number of Common Shares of the Principal Party in such Business Combination (if the Principal Party is not also the Surviving Person in such Business Combination) as shall have an aggregate Book Value immediately after giving effect to such Business Combination equal to the result obtained by multiplying the Purchase Price by two; or (3) if the Principal Party in such Business Combination is an Affiliate of one or more Persons which has Registered Common Shares outstanding, such number of Registered Common Shares of whichever of such Affiliates of the Principal Party has Registered Common Shares with the greatest aggregate Market Value on the date of consummation of such Business Combination as shall have an aggregate Market Value on the date of such Business Combination equal to the result obtained by multiplying the Purchase Price by two. (II) The Company shall not consummate any Business Combination unless each issuer of Common Shares for which Rights may be exercised, as set forth in this Section 11(c), shall have sufficient authorized Common Shares that have not been issued or reserved for issuance (and which shall, when issued upon exercise thereof in accordance with this Rights Agreement, be validly issued, fully paid and nonassessable and free of preemptive rights, rights of first refusal or any other restrictions or limitations on the transfer or ownership thereof) to permit the exercise in full of the Rights in accordance with this Section 11(c) and unless prior thereto: (i) a registration statement under the Securities Act on an appropriate form, with respect to the Rights and the Common Shares of such issuer purchasable upon exercise of the Rights, shall be effective under the Securities Act; and (ii) the Company and each such issuer shall have: (A) executed and delivered to the Rights Agent a supplemental agreement providing for the assumption by such issuer of the obligations set forth in this Section 11(c) (including the obligation of such issuer to issue 17 21 Exhibit 4.1 Common Shares upon the exercise of Rights in accordance with the terms set forth in Sections 11(c)(I) and 11(c)(III)) and further providing that such issuer, at its own expense, will use its best efforts to: (1) cause a registration statement under the Securities Act on an appropriate form, with respect to the Rights and the Common Shares of such issuer purchasable upon exercise of the Rights, to remain effective (with a prospectus at all times meeting the requirements of the Securities Act) until the Expiration Date; (2) qualify or register the Rights and the Common Shares of such issuer purchasable upon exercise of the Rights under the blue sky or securities laws of such jurisdictions as may be necessary or appropriate; and (3) list the Rights and the Common Shares of such issuer purchasable upon exercise of the Rights on each national securities exchange on which the Common Shares were listed prior to the consummation of the Business Combination or, if the Common Shares were not listed on a national securities exchange prior to the consummation of the Business Combination, on a national securities exchange; (B) furnished to the Rights Agent a written opinion of independent counsel stating that such supplemental agreement is a valid, binding and enforceable agreement of such issuer; and (C) filed with the Rights Agent a certificate of a nationally recognized firm of independent accountants setting forth the number of Common Shares of such issuer which may be purchased upon the exercise of each Right after the consummation of such Business Combination. (III) After consummation of any Business Combination and subject to the provisions of Section 11(c)(II), (i) each issuer of Common Shares for which Rights may be exercised as set forth in this Section 11(c) shall be liable for, and shall assume, by virtue of such Business Combination, all the obligations and duties of the Company pursuant to this Rights Agreement, (ii) The term "Company" shall thereafter be deemed to refer to such issuer, (iii) each such issuer shall take such steps in connection with such consummation as may be necessary to assure that the provisions hereof (including the provisions of Sections 11(a) and 11(c)) shall thereafter be applicable, as nearly as reasonably may be, in relation to its Common Shares thereafter deliverable upon the exercise of the Rights, and (iv) the number of Common Shares of each such issuer thereafter receivable upon exercise of any Right shall be subject to adjustment from time to time in a manner and on terms as nearly equivalent as practicable to the provisions of Sections 11 and 12 and the provisions of Section 7, 9 and 10 with respect to the Preferred Shares shall apply, as nearly as reasonably may be, on like terms to any such Common Shares. SECTION 12. Certain Adjustments. (a) To preserve the actual or potential economic value of the Rights, if at any time after the date of this Rights Agreement there shall be any change in the Common Shares or the Preferred Shares, whether by reason of stock dividends, stock splits, recapitalization, mergers, consolidations, combinations or exchanges of securities, split-ups, split-offs, spin-offs, liquidations, other similar changes in capitalization, any distribution or issuance of cash, assets, evidences of indebtedness or subscription rights, options or warrants to holders of Common Shares or Preferred Shares, as the case may be (other than distribution 18 22 Exhibit 4.1 of the Rights or regular quarterly cash dividends) or otherwise, then, in each such event the Board of Directors of the Company shall make such appropriate adjustments in the number of Preferred Shares (or the number and kind of other securities) issuable upon exercise of each Right, the Purchase Price and Redemption Price in effect at such time and the number of Rights outstanding at such time (including the number of Rights or fractional Rights associated with each Common Share) such that following each adjustment such event shall not have had the effect of reducing or limiting the benefits the holders of the Rights would have had absent such event. (b) If, as a result of an adjustment made pursuant to Section 12(a), the holder of any Right thereafter exercised shall become entitled to receive any securities other than Preferred Shares, thereafter the number of such securities so receivable upon exercise of any Right shall be subject to adjustment from time to time in a manner and on terms as nearly equivalent as practicable to the provisions of Sections 11 and 12 and the provisions of Sections 7, 9 and 10 with respect to the Preferred Shares shall apply, as nearly as reasonably may be, on like terms to any such other securities. (c) All Rights originally issued by the Company subsequent to any adjustment made to the amount of Preferred Shares or other securities relating to a Right shall evidence the right to purchase, for the Purchase Price, the adjusted number and kind of securities purchasable from time to time hereunder upon exercise of the Rights, all subject to further adjustment as provided herein. (d) Irrespective of any adjustment or change in the Purchase Price or the number of Preferred Shares or number of kind of other securities issuable upon the exercise of the Rights, the Right Certificates theretofore and thereafter issued may continue to express the terms which were expressed in the initial Right Certificates issued hereunder. (e) In any case in which action taken pursuant to Section 12(a) requires that an adjustment be made effective as of a record date for a specified event, the Company may elect to defer until the occurrence of such event the issuing to the holder of any Right exercised after such record date the Preferred Shares and/or other securities, if any, issuable upon such exercise over and above the Preferred Shares and/or other securities, if any, issuable before giving effect to such adjustment; provided, however, that the Company shall deliver to such holder a due bill or other appropriate instrument evidencing such holder's right to receive such additional securities upon the occurrence of the event requiring such adjustment. SECTION 13. Certificate of Adjustment. Whenever an adjustment is made as provided in Section 11 or 12, the Company shall (a) promptly prepare a certificate setting forth such adjustment and a brief statement of the facts accounting for such adjustment (b) promptly file with the Rights Agent and with each transfer agent for the Preferred Shares a copy of such certificate and (c) mail a brief summary thereof to each holder of a Right Certificate (or, prior to the Distribution Date, of the Common Shares) in accordance with Section 25. The Rights Agent shall be fully protected in relying on any such certificate and on any adjustment therein contained. SECTION 14. Additional Covenants. (a) Notwithstanding any other provision of this Rights Agreement, no adjustment to the number of Preferred Shares (or fractions of a share) or other 19 23 Exhibit 4.1 securities or which a Right is exercisable or the number of Rights outstanding or associated with each Common Share or any similar or other adjustment shall be made or be effective if such adjustment would have the effect of reducing or limiting the benefits the holders of the Rights would have had absent such adjustment, including, without limitation, the benefits under Sections 11 and 12, unless the terms of this Rights Agreement are amended so as to preserve such benefits. (b) The Company covenants and agrees that, after the Distribution Date, except as permitted by Section 26, it will not take (or permit any Subsidiary of the Company to take) any action if at the time such action is taken it is intended or reasonably foreseeable that such action will reduce or otherwise limit the benefits the holders of the Rights would have had absent such action, including, without limitations, the benefits under Sections 11 and 12. Any action taken by the Company during any period after any Person becomes an Acquiring Person but prior to the Distribution Date shall be null and void unless such action could be taken under this Section 14(b) from and after the Distribution Date. The Company shall not consummate any Business Combination if any issuer of Common Shares for which Rights may be exercised after such Business Combination in accordance with Section 11(c) shall have taken any action that reduces or otherwise limits the benefits the holders of the Rights would have had absent such action, including, without limitation, the benefits under Sections 11 and 12. SECTION 15. Fractional Rights and Fractional Shares. (a) The Company may, but shall not be required to, issue fractions of Rights or distribute Right Certificates which evidence fractional Rights. In lieu of such fractional Rights, the Company may pay to the registered holders of the Right Certificates with regard to which such fractional Rights would otherwise be issuable an amount in cash equal to the same fraction of the current market value of a whole Right. For purposes of this Section 15(a), the current market value of a whole Right shall be the closing price of the Rights (as determined pursuant to the second and third sentences of the definition of Market Value contained in Section 1) for the Trading Day immediately prior to the date on which such fractional Rights would have been otherwise issuable. (b) The Company may, but shall not be required to, issue fractions of Preferred Shares upon exercise of the Rights or distribute certificates which evidence fractional Preferred Shares. In lieu of fractional Preferred Shares, the Company may elect to (i) utilize a depository arrangement as provided by the terms of the Preferred Shares or (ii) in the case of a fraction of a Preferred Share (other than one one-thousandths (1/1,000ths) of a Preferred Share or any integral multiple thereof), pay to the registered holders of Right Certificates at the time such Rights are exercised as herein provided an amount in cash equal to the same fraction of the current market value of one Preferred Share, if any are outstanding and publicly traded (or the Formula Number times the current market value of one Common Share if the Preferred Shares are not outstanding and publicly traded). For purposes of this Section 15(b), the current market value of a Preferred Share (or Common Share) shall be the closing price of a Preferred Share (or Common Share) (as determined pursuant to the second and third sentences of the definition of Market Value contained in Section 1) for the Trading Day immediately prior to the date of such exercise. If, as a result of an adjustment made pursuant to Section 12(a), the holder of any Right thereafter exercised shall become entitled to receive any securities other than Preferred Shares, the provisions of this Section 15(b) shall apply, as nearly as reasonably may be, on like terms to such other securities. 20 24 Exhibit 4.1 (c) The Company may, but shall not be required to, issue fractions of Common Shares upon exchange of Rights pursuant to Section 11(b), or to distribute certificates which evidence fractional Common Shares. In lieu of such fractional Common Shares, the Company may pay to the registered holders of the Right Certificates with regard to which such fractional Common Shares would otherwise be issuable an amount in cash equal to the same fraction of the current Market Value of one Common Share as of the date on which a Person became an Acquiring Person. (d) The holder of Rights by the acceptance of the Rights expressly waives his right to receive any fractional Rights or any fractional shares upon exercise of a Right except as provided in this Section 15. SECTION 16. Rights of Action. (a) All rights of action in respect of this Rights Agreement are vested in the respective registered holders of the Right Certificates (and, prior to the Distribution Date, the registered holders of the Common Shares); and any registered holder of any Right Certificate (or, prior to the Distribution Date, of the Common Shares), without the consent of the Rights Agent or of the holder of any other Right Certificate (or, prior to the Distribution Date, of the Common Shares) may, in his own behalf and for his own benefit, enforce, and may institute and maintain any suit, action or proceeding against the Company to enforce, or otherwise act in respect of, his right to exercise the Rights evidenced by such Right Certificate in the manner provided in such Right Certificate and in this Rights Agreement. Without limiting the foregoing or any remedies available to the holders or Rights, it is specifically acknowledged that the holders of Rights would not have an adequate remedy at law for any breach of this Rights Agreement and shall be entitled to specific performance of the obligations of any Person under, and injunctive relief against actual or threatened violations of the obligations of any Person subject to, this Rights Agreement. (b) Any holder of Rights who prevails in an action to enforce the provisions of this Rights Agreement shall be entitled to recover the reasonable costs and expenses, including attorneys' fees, incurred in such action. SECTION 17. Transfer and Ownership of Rights and Right Certificates. (a) Prior to the Distribution Date, the Rights will be transferable only in connection with the transfer of the Common Shares. (b) After the Distribution Date, the Right Certificates will be transferable, subject to Section 7(e), only on the registry books of the Rights Agent, if surrendered at the principal office of the Rights Agent, duly endorsed or accompanied by a proper instrument of transfer. (c) The Company and the Rights Agent may deem and treat the Person in whose name a Right Certificate (or, prior to the Distribution Date, the associated Common Shares certificate) is registered as the absolute owner thereof and of the Rights evidenced thereby (notwithstanding any notations of ownership or writing on the Right Certificates or the associated certificate for Common Shares made by anyone other than the Company or the Rights Agent) for all purposes whatsoever, and neither the Company nor the Rights Agent shall be affected by any notice to the contrary. 21 25 Exhibit 4.1 SECTION 18. Right Certificate Holder Not Deemed a Stockholder. No holder, as such, of any Right Certificate shall be entitled to vote or receive dividends or be deemed, for any purpose, the holder of the Preferred Shares or of any other securities of the Company which may at any time be issuable on the exercise of the Rights represented thereby, nor shall anything contained herein or in any Right Certificate be construed to confer upon the holder of any Right Certificate, as such, any of the rights of a stockholder of the Company, including, without limitation, any right to vote for the election of directors or upon any matter submitted to stockholders at any meeting thereof, or to give or withhold consent to any corporate action, or to receive notice of meetings or other actions affecting stockholders, or to receive dividends or other distributions or subscription rights, or otherwise, until the Right or Rights evidenced by such Right Certificate shall have been exercised in accordance with the provisions hereof. SECTION 19. Concerning the Rights Agent. (a) The Company agrees to pay to the Rights Agent reasonable compensation for all services rendered by it hereunder and from time to time, on demand of the Rights Agent, its reasonable expenses and counsel fees and other disbursements incurred in the administration and execution of this Rights Agreement and the exercise and performance of its duties hereunder. (b) The Rights Agent shall be protected and shall incur no liability for or in respect of any action taken, suffered or omitted by it in connection with its administration of this Rights Agreement in reliance upon any Right Certificate or certificate for the Common Shares or for other securities of the Company, instrument of assignment or transfer, power of attorney, endorsement, affidavit, letter, notice, direction, consent, certificate, statement, or other paper or document believed by it to be genuine and to be signed, executed and, where necessary, verified or acknowledged, by the proper Person or Persons. SECTION 20. Merger or Consolidation or Change of Rights Agent. (a) Any corporation into which the Rights Agent or any successor Rights Agent may be merged or with which it may be consolidated, or any corporation resulting from any merger or consolidation to which the Rights Agent or any successor Rights Agent shall be a party, or any corporation succeeding to the stock transfer or corporate trust business of the Rights Agent or any successor Rights Agent, shall be the successor to the Rights Agent under this Rights Agreement without the execution or filing of any paper or any further act on the part of any of the parties hereto; provided that such corporation would be eligible for appointment as a successor Rights Agent under the provisions of Section 22. In case, at the time such successor Rights Agent may adopt the countersignature of the predecessor Rights Agent shall succeed to the agency created by this Rights Agreement, of any of the Right Certificates shall have been countersigned but not delivered, any such successor Rights Agent may adopt the countersignature of the predecessor Rights Agent and deliver such Right Certificates so countersigned; and, in case at that time any of the Right Certificates shall not have been countersigned, any successor Rights Agent countersign such Right Certificate either in the name of the predecessor Rights Agent or in the name of the successor Rights Agent; and in all such cases such Right Certificates shall have the full force provided in the Right Certificates and in this Rights Agreement. 22 26 Exhibit 4.1 (b) In case at any time the name of the Rights Agent shall be changed and at such time any of the Right Certificates shall have been countersigned but not delivered, the Rights Agent may adopt the countersignature under its prior name and deliver Right Certificates so countersigned; and, in case at that time any of the Right Certificates shall have been countersigned but not delivered, the Rights Agent may adopt the countersignature under its prior name and deliver Right Certificates so countersigned; and, in case at that time any of the Rights Certificates shall not have been countersigned, the Rights Agent may countersign such Right Certificate either in its prior name or in its changed name; and in all such cases such Right Certificates shall have the full force provided in the Right Certificates and in this Rights Agreement. SECTION 21. Duties of Rights Agent. The Rights Agent undertakes the duties and obligations imposed by this Rights Agreement upon the following terms and conditions, by all of which the Company and the holders of Rights Certificates (or, prior to the Distribution Date, of the Common Shares), by their acceptance thereof, shall be bound: (a) The Rights Agent may consult with legal counsel (who may be legal counsel for the Company), and the opinion of such counsel shall be full and complete authorization and protection to the Rights Agent as to any action taken, suffered or omitted by it in good faith and in accordance with such opinion. (b) Whenever in the performance of its duties under this Rights Agreement the Rights Agent shall deem it necessary or desirable that any fact or matter (including, without limitation, the identity of any Acquiring Person) be proved or established by the Company prior to taking, refraining from taking or suffering any action hereunder, such fact or matter (unless other evidence in respect thereof be herein specifically prescribed) may be deemed to be conclusively proved and established by a certificate signed by any one of the Chairman of the Board, the Chief Executive Officer, the President, the Chief Operating Officer, the Chief Financial Officer, a Vice President (whether preceded by any additional title), the Treasurer or the Secretary of the Company and delivered to the Rights Agent; and such certificate shall be full authorization to the Rights Agent for any action taken or suffered in good faith by it under the provisions of this Rights Agreement in reliance upon such certificate. (c) The Rights Agent shall be liable hereunder only for its own negligence, bad faith or wilful misconduct. (d) The Rights Agent shall not be liable for or by reason of any of statements of fact or recitals contained in this Rights Agreement or in the Right Certificates (except as to its countersignature thereof) or be required to verify the same, but all such statements and recitals are and shall be deemed to have been made by the Company only. (e) The Rights Agent shall not be under any responsibility in respect of the validity of this Rights Agreement or the execution and delivery hereof (except the due execution hereof by the Rights Agent) or in respect of the validity or execution of any Right Certificate (except its countersignature thereof); nor shall it be responsible for any breach by the Company of any covenant or condition contained in this Rights Agreement or in any Right Certificate; nor shall it be responsible for any adjustment required under the provisions of Section 11 or 12 or responsible for the manner, method or amount of any such adjustment or the ascertaining of the existence of facts that would require any such adjustment (except with respect to the exercise of Rights 23 27 Exhibit 4.1 evidenced by Right Certificates after actual notice of any such adjustment); nor shall it by any act hereunder be deemed to make any representation or warranty as to the authorization or reservation of any Preferred Shares or Common Shares to be issued pursuant to this Rights Agreement or any Right Certificate or as to whether any Preferred Shares or Common Shares will, when so issued, be validly authorized and issued, fully paid and nonassessable. (f) The Company agrees that it will perform, execute, acknowledge and deliver or cause to be performed, executed, acknowledged and delivered all such further and other acts, instruments and assurances as may reasonably be required by the Rights Agent for the carrying out or performing by the Rights Agent of the provisions of this Rights Agreement. (g) The Rights Agent is hereby authorized and directed to accept instructions with respect to the performance of its duties hereunder from any one of the Chairman of the Board, the Chief Executive Officer, the President, the Chief Operating Officer, a Vice President (whether preceded by any additional title), the Secretary or the Treasurer of the Company, in connection with its duties and it shall not be liable for any action taken or suffered to be taken by it in good faith in accordance with instructions of any such officer. (h) The Rights Agent and any stockholder, director, officer or employee of the Rights Agent may buy, sell or deal in any of the Rights or other securities of the Company or become pecuniarily interested, or contract with or lend money to the Company or otherwise act as fully and freely as though it were not the Rights Agent under this Rights Agreement. Nothing herein shall preclude the Rights Agent from acting in any other capacity for the Company or for any other legal entity. (i) The Rights Agent may execute an exercise any of the rights or powers hereby vested in it or perform any duty hereunder either itself or by or through its attorneys or agents, and the Rights Agent shall not be answerable or accountable for any act, default, neglect or misconduct of any such attorneys or agents of for any loss to the Company resulting from any such act, default, neglect or misconduct provided reasonable care was exercised in the selection and continued employment thereof. (j) The Company agrees to indemnify and to hold the Rights Agent harmless against any loss, liability, damage or expense (including reasonable fees and expenses of (legal counsel) which the Rights Agent may incur resulting from its actions as Rights Agent pursuant to this Rights Agreement; provided, however, that the Rights Agent shall not be indemnified or held harmless with respect to any such loss, liability, damage or expense incurred by the Rights Agent as a result of, or arising out of, its own negligence, bad faith or wilful misconduct. In no case shall the Company be liable with respect to any action, proceeding, suit or claim against the Rights Agent unless the Rights Agent shall have notified the Company, by letter or by facsimile confirmed by letter, of the assertion of any action, proceeding, suit or claim against the Rights Agent, promptly after the Rights Agent shall have notice of any such assertion of an action, proceeding, suit or claim or have been served with the summons or other first legal process giving information as to the nature and basis of the action, proceeding, suit or claim. The Company shall be entitled to participate at its own expense in the defense of any such action, proceeding, suit or claim, and, if the Company so elects, the Company shall assume the defense of any such action, proceeding, suit or claim. In the event that the Company assumes such defense, the Company shall not thereafter be liable for the fees and expenses of any additional counsel retained by the Rights Agent, so long as the Company shall 24 28 Exhibit 4.1 retain counsel satisfactory to the Rights Agent, in the exercise of its reasonable judgment, to defend such action, proceeding, suit or claim. The Rights Agent agrees not to settle any litigation in connection with any action, proceeding, suit or claim with respect to which it may seek indemnification from the Company without the prior written consent of the Company. SECTION 22. Change of Rights Agent. The Rights Agent or any successor Rights Agent may resign and be discharged from its duties under this Rights Agreement upon 30 days' notice in writing mailed to the Company and to each transfer agent of the Common Shares and the Preferred Shares by registered or certified mail, and to the holders of the Right Certificates (or, prior to the Distribution Date, of the Common Shares) by first-class mail. The Company may remove the Rights Agent or any successor Rights Agent upon 30 days' notice in writing, mailed to the Rights Agent or successor Rights Agent, as the case may be, and to each transfer agent of the Common Shares and the Preferred Shares by registered or certified mail, and to the holders of the Right Certificates (or, prior to the Distribution Date, of the Common Shares) by first-class mail. If the Rights Agent shall resign or be removed or shall otherwise become incapable of acting, the Company shall appoint a successor to the Rights Agent. If the Company shall fail to make such appointment within a period of 30 days after giving notice of such removal or after it has been notified in writing of such resignation or incapacity by the resigning or incapacitated Rights Agent or by the holder of a Right Certificate (or, prior to the Distribution Date, of the Common Shares) (who shall, with such notice, submit his Right Certificate or, prior to the Distribution Date, the certificate representing his Common Shares, for inspection by the Company), then the registered holder of any Right Certificate (or, prior to the Distribution Date, of the Common Shares) may apply to any court of competent jurisdiction for the appointment of a new Rights agent. Any successor Rights Agent, whether appointed by the Company or by such court, shall be a corporation organized and doing business under the laws of the United States or of the State of New Jersey or New York (or of any other state of the United States so long as such corporation is authorized to conduct a stock transfer or corporate trust business in the State of New Jersey or New York), in good standing, having a principal office in the State of New Jersey or New York, which is authorized under such laws to exercise stock transfer or corporate trust powers and is subject to supervision or examination by Federal or state authority and which has at the time of its appointment as Rights Agent a combined capital and surplus of at least $20,000,000; provided that the principal transfer agent for the Common Shares shall in any event be qualified to be the Rights Agent. After appointment, the successor Rights Agent shall be vested with the same powers, rights, duties and responsibilities as if it had been originally named as Rights Agent without further act or deed; but the predecessor Rights Agent shall deliver and transfer to the successor Rights Agent any property at the time held by it hereunder, and execute and deliver any further assurance, conveyance, act or deed necessary for the purpose. Not later than the effective date of any such appointment, the Company shall file notice thereof in writing with the predecessor Rights Agent and each transfer agent of the Common Shares and the Preferred Shares, and mail a notice thereof in writing to the registered holders of the Right Certificates (or, prior to the Distribution Date, of the Common Shares). Failure to give any notice provided for in this Section 22, however, or any defect therein shall not affect the legality or validity of the resignation or removal of the Rights Agent or the appointment of the successor Rights Agent, as the case may be. SECTION 23. Issuance of Additional Rights and Right Certificates. Notwithstanding any of the provisions of this Rights Agreement or of the Rights to the contrary, the Company may, at its option, issue new Right 25 29 Exhibit 4.1 Certificates evidencing Rights in such form as may be approved by its Board of Directors to reflect any adjustment or change made in accordance with the provisions of this Rights Agreement. In addition, in connection with the issuance or sale of Common Shares following the Distribution Date and prior to the earlier of the Redemption Date and the Expiration Date, the Company (a) shall, with respect to Common Shares so issued or sold pursuant to the exercise of stock options or under any employee plan or arrangement, or upon the exercise, conversion or exchange of securities, notes or debentures issued by the Company, and (b) may, in any other case, if deemed necessary or appropriate by the Board of Directors number of Rights in connection with such issuance or sale; provided, however, that (i) no such Right Certificate shall be issued if, and to the extent that, the Company shall be advised by counsel that such issuance would create a significant risk of material adverse tax consequences to the Company or the Person to whom such Right Certificate wold be issued, and (ii) no such Right Certificate shall be issued if, and to the extent that, appropriate adjustment shall otherwise have been made in lieu of the issuance thereof. SECTION 24. Redemption and Termination. (a) The Board of Directors of the Company may, at its option, at any time prior to the earlier of (i) such time as a Person becomes an Acquiring Person and (ii) the Expiration Date, order the redemption of all, but not fewer than all, the then outstanding Rights at the Redemption Price (the date of such redemption being the "Redemption Date"), and the Company, at its option, may pay the Redemption Price either in cash or Common Shares or other securities of the Company deemed by the Board of Directors of the Company, in the exercise of its sole discretion, to be at least equivalent in value to the Redemption Price; provided, however, that, in addition to any other limitations contained herein on the right to redeem outstanding Rights (including the occurrence of any event or the expiration of any period after which the Rights may no longer be redeemed), for the 120-day period after any date of a change (resulting from a proxy or consent solicitation) in a majority of the Board of Directors of the Company in office at the commencement of such solicitation, the Rights may only be redeemed if (A) there are directors then in office who were in office at the commencement of such solicitation and (B) the Board of Directors of the Company, with the concurrence of a majority of such directors then in office, determines that such redemption is, in their judgment, in the best interests of the Company and its stockholders. (b) Immediately upon the action of the Board of Directors of the Company ordering the redemption of the Rights, and without any further action and without any notice, the right to exercise the Rights will terminate and the only right thereafter of the holders of Rights shall be to receive the Redemption Price. Within 10 Business Days after the action of the Board of Directors of the Company ordering the redemption of the Rights, the Company shall give notice of such redemption to the holders of the then outstanding Rights by mailing such notice to all such holders at their last addresses as they appear upon the registry books of the Rights Agent or, prior to the Distribution Date, on the registry books of the transfer agent for the Common Shares. Each such notice of redemption will state the method by which payment of the Redemption Price will be made. The notice, if mailed in the manner herein provided, shall be conclusively presumed to have been duly given, whether or not the holder of Rights receives such notice. In any case, failure to give such notice by mail, or any defect in the notice, to any particular holder of Rights shall not affect the sufficiency of the notice to other holders of Rights. 26 30 Exhibit 4.1 SECTION 25. Notices. Notices or demands authorized by this Agreement to be given or made by the Rights Agent or by the holder of a Right Certificate (or, prior to the Distribution Date, of the Common Shares) to or on the Company shall be sufficiently given or made if sent by first-class mail, postage prepaid, addressed (until another address is filed in writing with the Rights Agent) as follows: Alteon, Inc. 170 Williams Drive Ramsey, New Jersey 07446 Attn: Chief Executive Officer Subject to the provisions of Section 22, any notice or demand authorized by this Rights Agreement to be given or made by the Company or by the holder of a Right Certificate (or, prior to the Distribution Date, of the Common Shares) to or on the Rights Agent shall be sufficiently given or made if sent by first-class mail, postage prepaid, addressed (until another address is filed in writing with the Company) as follows: Registrar and Transfer Company 10 Commerce Drive Cranford, New Jersey 07061 Attn: Corporate Relations Department Notices or demands authorized by this Rights Agreement to be given or made by the Company or the Rights Agent to any holder of a Right Certificate (or, prior to the Distribution Date, of the Common Shares) shall be sufficiently given or made if sent by first-class mail, postage prepaid, addressed to such holder at the address of such holder as shown on the registry books of the Rights Agent or, prior to the Distribution Date, on the registry books of the transfer agent for the Common Shares. SECTION 26. Supplements and Amendments. At any time prior to the Distribution Date and subject to the last sentence of this Section 26, the Company may, and the Rights Agent shall if the Company so directs, supplement or amend any provision of this Rights Agreement (including, without limitation, the date on which the Distribution Date shall occur, the time during which the Rights may be redeemed pursuant to Section 24 or any provision of the Certificate of Designation) without the approval of any holder of the Rights. From and after the Distribution Date and subject to applicable law, the Company may, and the Rights Agent shall if the Company so directs, amend this Rights Agreement without the approval of any holders of Right Certificates (i) to cure an ambiguity or to correct or supplement any provision contained herein which may be defective or inconsistent with any other provision of this Rights Agreement or (ii) to make any other provisions in regard to matters or questions arising hereunder which the Company may deem necessary or desirable and which shall not adversely affect the interests of the holders of Right Certificates (other than an Acquiring Person or an Affiliate or Associate of an Acquiring Person). Any supplement or amendment adopted during any period after any Person has become an Acquiring Person but prior to the Distribution Date shall be null and void unless such supplement or amendment could have been adopted under the prior sentence from and after the Distribution Date. Any supplement or amendment to this Rights Agreement duly approved by the Company that does not amend Sections 19, 20, 21 or 22 in a manner adverse to the Rights Agent shall become effective immediately upon execution by the Company, whether or not also executed by the Rights Agent. Notwithstanding anything contained in this Rights Agreement to the contrary, during the 120-day period after any date of a change (resulting from a proxy or 27 31 Exhibit 4.1 consent solicitation) in a majority of the Board of Directors of the Company in office at the commencement of such solicitation, this Rights Agreement may be supplemented or amended only if (A) there are directors then in office who were in office at the commencement of such solicitation and (B) the Board of Directors of the Company, with the concurrence of a majority of such directors then in office, determines that such supplement or amendment is, in their judgment, in the best interests of the Company and its stockholders and, after the Distribution Date, the holders of the Right Certificates. In addition, notwithstanding anything to the contrary contained in this Rights Agreement, no supplement or amendment to this Rights Agreement shall be made which (a) reduces the Redemption Price (except as required by Section 12(a)) or (b) provides for an earlier Expiration Date. SECTION 27. Successors. All the covenants and provisions of this Rights Agreement by or for the benefit of the Company or the Rights Agent shall bind and inure to the benefit of their respective successors and assigns hereunder. SECTION 28. Benefits of Rights Agreement; Determinations and Actions by the Board of Directors, etc. (a) Nothing in this Rights Agreement shall be construed to give to any Person other than the Company, the Rights Agent and the registered holders of the Right Certificates (and, prior to the Distribution Date, of the Common Shares) any legal or equitable right, remedy or claim under this Rights Agreement; but this Rights Agreement shall be for the sole and exclusive benefit of the Company, the Rights Agent and the registered holders of the Right Certificates (and, prior to the Distribution Date, of the Common Shares). (b) Except as explicitly otherwise provided in this Rights Agreement, the Board of Directors of the Company shall have the exclusive power and authority to administer this Rights Agreement and to exercise all rights and powers specifically granted to the Board of Directors of the Company or to the Company, or as may be necessary or advisable in the administration of this Rights Agreement, including, without limitation, the right and power to (i) interpret the provisions of this Rights Agreement and (ii) make all determinations deemed necessary or advisable for the administration of this Rights Agreement (including, without limitation, a determination to redeem or not redeem the Rights or to amend this Rights Agreement and a determination of whether an offer constitutes a Qualifying Offer and whether there is an Acquiring Person). (c) Nothing contained in this Rights Agreement shall be deemed to be in derogation of the obligation of the Board of Directors of the Company to exercise its fiduciary duty. Without limiting the foregoing, nothing contained herein shall be construed to suggest or imply that the Board of Directors shall not be entitled to reject any Qualifying Offer or any other tender offer, or to recommend that holders of Common Shares reject any Qualifying Offer or any other tender offer, or to take any other action (including, without limitation, the commencement, prosecution, defense or settlement of any litigation and the submission of additional or alternative offers or other proposals) with respect to any Qualifying Offer or any other tender offer that the Board of Directors believes is necessary or appropriate in the exercise of such fiduciary duty. SECTION 29. Severability. If any term, provision, covenant or restriction of this Rights Agreement is held by a court of competent jurisdiction or other authority to be invalid, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions of this Rights Agreement shall remain in full force and effect and shall in no way be affected, impaired or invalidated. 28 32 Exhibit 4.1 SECTION 30. Governing Law. This Rights Agreement and each Right Certificate issued hereunder shall be deemed to be a contract made under the law of the State of Delaware and for all purposes shall be governed by and construed in accordance with the law of such State applicable to contracts to be made and performed entirely within such State. SECTION 31. Counterparts; Effectiveness. This Rights Agreement may be executed in any number of counterparts and each of such counterparts shall for all purposes be deemed to be an original, and all such counterparts shall together constitute but one and the same instrument. This Rights Agreement shall be effective as of the Close of Business on the date hereof. SECTION 32. Descriptive Headings. Descriptive headings of the several Sections of this Rights Agreement are inserted for convenience only and shall not control or affect the meaning or construction of any of the provisions of this Rights Agreement. IN WITNESS WHEREOF, the parties hereto have caused this Rights Agreement to be duly executed as of the day and year first above written. ALTEON INC. by: /s/ James J. Mauzey --------------------------------- Name: James J. Mauzey Title: Chairman & Chief Executive Officer REGISTRAR AND TRANSFER COMPANY, as Rights Agent by: /s/ William P. Tatler --------------------------------- Name: William P. Tatler Title: Vice President 29 33 Exhibit 4.1 Exhibits to Rights Agreement. 30 34 Exhibit 4.1 EXHIBIT A CERTIFICATE OF THE VOTING POWERS, DESIGNATIONS, PREFERENCES AND RELATIVE PARTICIPATING, OPTIONAL AND OTHER SPECIAL RIGHTS AND QUALIFICATIONS, LIMITATIONS OR RESTRICTIONS OR SERIES F PREFERRED STOCK OF ALTEON INC. Pursuant to Section 151 of the General Corporation Law of the State of Delaware, Alteon Inc. (the "Corporation") organized and existing under the General Corporation Law of the State of Delaware, in accordance with the provisions of Section 103 thereof, DOES HEREBY CERTIFY: That, pursuant to the authority conferred upon the Board of Directors of the Corporation by Article Fifth of the Restated Certificate of Incorporation of the Corporation (the "Certificate of Incorporation"), the Board of Directors of the Corporation on __________, 1995, adopted the following resolution creating a series of Preferred Stock designated as Series F Preferred Stock: RESOLVED, that, pursuant to the authority vested in the Board of Directors of the Corporation in accordance with the provisions of the Certificate of Incorporation of the Corporation, a series of Preferred Stock of the Corporation is hereby created and that the designation and number of shares thereof an the voting powers, preferences and relative, participating, optional and other special rights of the shares of such series, and the qualifications, limitations or restrictions thereof are as follows: SECTION 1. Designation and Number of Shares. The shares of such series shall be designated as "Series F Preferred Stock" (the "Series F Preferred Stock"), par value $0.01 per share. The number of shares initially constituting the Series F Preferred Stock shall be 400,000; provided, however, that, if more than a total of 400,000 shares of Series F Preferred Stock shall be issuable upon the exercise of Rights (the "Rights") issued pursuant to the Stockholders Rights Agreement dated as of ________________, 1995, between the Corporation and Registrar and Transfer Company, as Rights Agent (the "Rights Agreement"), the Board of Directors of the Corporation, pursuant to Section 151(g) of the General Corporation Law of the State of Delaware, shall direct by resolution or resolutions that a certificate be properly executed, acknowledged, filed and recorded, in accordance with the provisions of Section 103 thereof, providing for the total number of shares of Series F Preferred Stock authorized to be issued to be increased (to the extent that the Certificate of Incorporation then permits) to the largest number of whole shares (rounded up to the nearest whole number) issuable upon exercise of such Rights. SECTION 2. Dividends or Distributions. (a) Subject to the prior and superior rights of the holders of shares of any other series of Preferred Stock or other class of capital stock of the Corporation ranking prior and superior to the shares of Series F Preferred Stock with respect to dividends, the holders of shares of the Series F Preferred Stock shall be entitled to receive, when, as and if declared by the Board of Directors, out of the assets of the Corporation legally available therefore, (1) quarterly dividends payable in cash on the last day of each fiscal quarter in each year, or such other dates as the Board of 31 35 Exhibit 4.1 Directors of the Corporation shall approve (each such date being referred to herein as a "Quarterly Dividend Payment Date"), commencing on the first Quarterly Dividend Payment Date after the first issuance of a share or a fraction of a share of Series F Preferred Stock, in the amount of $.01 per whole share (rounded to the nearest cent) less the amount of all cash dividends declared on the Series F Preferred Stock pursuant to the following clause (2) since the immediately preceding Quarterly Dividend Payment Date or, with respect to the first Quarterly Dividend Payment Date, since the first issuance of any share or fraction of a share of Series F Preferred Stock (the total of which shall not, in any event, be less than zero) and (2) dividends payable in cash on the payment date for each cash dividend declared on the Common Stock in an amount per whole share (rounded to the nearest cent) equal to the Formula Number (as hereinafter defined) then in effect times the cash dividends then to be paid on each share of Common Stock. In addition, if the Corporation shall pay any dividend or make any distribution on the Common Stock payable in assets, securities or other forms of noncash consideration (other than dividends or distributions solely in shares of Common Stock), then, in each such case, the Corporation shall simultaneously pay or make on each outstanding whole share of Series F Preferred Stock a dividend or distribution in like kind equal to the Formula Number then in effect times such dividend or distribution on each share of the Common Stock. As used herein, the "Formula Number" shall be 1,000; provided, however, that, if at any time after July 20, 1995, the Corporation shall (i) declare or pay any dividend on the Common Stock payable in shares of Common Stock or make any distribution on the Common Stock in share of Common Stock, (ii) subdivide (by a stock split or otherwise) the outstanding shares of Common Stock into a larger number of shares of Common Stock or (iii) combine (by a reverse stock split or otherwise) the outstanding shares of Common Stock, into a smaller number of shares of Common Stock, then in each such event the Formula Number shall be adjusted to a number determined by multiplying the Formula Number in effect immediately prior to such event by a fraction, the numerator of which is the number of shares of Common Stock that are outstanding immediately after such event and the denominator of which is the number of shares of Common Stock that are outstanding immediately prior to such event (and rounding the result to the nearest whole number); and provided further, that, if an any time after July 20, 1995, the Corporation shall issue any shares of its capital stock in a merger, reclassification, or change of the outstanding shares of Common Stock, then in each such event the Formula Number shall be appropriately adjusted to reflect such merger, reclassification or change so that each share of Preferred Stock continues to be the economic equivalent of a Formula Number of shares of Common Stock prior to such merger, reclassification or change. (b) The Corporation shall declare a dividend or distribution on the Series F Preferred Stock as provided in Section 2(a) immediately prior to or at the same time it declares a dividend or distribution on the Common Stock (other than a dividend or distribution solely in shares of Common Stock); provided, however, that, in the event no dividend or distribution (other than a dividend or distribution in shares of Common Stock) shall have been declared on the Common Stock during the period between any Quarterly Dividend Payment Date and the next subsequent Quarterly Dividend Payment Date, a dividend of $.01 per share on the Series F Preferred Stock shall nevertheless be payable on such subsequent Quarterly Dividend Payment Date. The Board of Directors may fix a record date for the determination of holders of shares of Series F Preferred Stock entitled to receive a dividend or distribution declared thereon, which record date shall be the same as the record date for corresponding dividend or distribution on the Common Stock. 32 36 Exhibit 4.1 (c) Dividends shall begin to accrue and be cumulative on outstanding shares of Series F Preferred Stock from and after the Quarterly Dividend Payment Date next preceding the date of original issue of such shares of Series F Preferred Stock; provided, however, that dividends on such shares which are originally issued after the record date for the determination of holders of shares of Series F Preferred Stock entitled to receive a quarterly dividend and on or prior to the next succeeding Quarterly Dividend Payment Date shall begin to accrue and be cumulative from and after such Quarterly Dividend Payment Date. Notwithstanding the foregoing, dividends on shares of Series F Preferred Stock which are originally issued prior to the record date for the determination of holders of shares of Series F Preferred Stock entitled to receive a quarterly dividend on the first Quarterly Dividend Payment Date shall be calculated as if cumulative from and after the last day of the fiscal quarter next preceding the date of original issuance of such shares. Accrued but unpaid dividends shall not bear interest. Dividends paid on the shares of Series F Preferred Stock in an amount less than the total amount of such dividends at the time accrued and payable on such shares shall be allocated pro rata on a share-by-share basis among all such shares at the time outstanding. (d) So long as any shares of the Series F Preferred Stock are outstanding, no dividends or other distributions shall be declared, paid or distributed, or set aside for payment or distribution, on the Common Stock unless, in each case, the dividend required by this Section 2 to be declared on the Series F Preferred Stock shall have been declared. (e) The holders of the shares of Series F Preferred Stock shall not be entitled to receive any dividends or other distribution except as provided herein. SECTION 3. Voting Rights. The holders of shares of Series F Preferred Stock shall have the following voting rights: (a) Each holder of Series F Preferred Stock shall be entitled to a number of votes equal to the Formula Number then in effect, for each share of Series F Preferred Stock held of record on each matter on which holders of the Common Stock or stockholders generally are entitled to vote, multiplied by the maximum number of votes per share which any holder of the Common Stock or stockholders generally then have with respect to such matter (assuming any holding period or other requirement to vote a greater number of shares is satisfied). (b) Except as otherwise provided herein or by applicable law, the holders of shares of Series F Preferred Stock and the holders of shares of Common Stock shall vote together as one class for the election of directors of the Corporation and on all other matters submitted to a vote of stockholders of the Corporation. (c) If, at the time of any annual meeting of stockholders for the election of directors, the equivalent of six quarterly dividends (whether or not consecutive) payable on any share or shares of Series F Preferred Stock are in default, the number of directors constituting the Board of Directors of the Corporation shall be increased by two. In addition to voting together with the holders of Common Stock for the election of other directors of the Corporation, the holders of record of the Series F Preferred Stock, voting separately as a class to the exclusion of the holders of Common Stock, shall be entitled at said meeting of stockholders (and at each subsequent annual meeting of stockholders), unless all dividends in arrears have been paid or declared and set apart for 33 37 Exhibit 4.1 payment prior thereto, to vote for the election of two directors of the Corporation, the holders of any Series F Preferred Stock being entitled to cast a number of votes per share of Series F Preferred Stock equal to the Formula Number. Until the default in payments of all dividends which permitted the election of said directors shall cease to exist, any director who shall have been so elected pursuant to the next preceding sentence may be removed at any time, either with or without cause, only by the affirmative vote of the holders of the shares of Series F Preferred Stock at the time entitled to cast a majority of the votes entitled to be cast for the election of any such director at a special meeting of such holders called for that purpose, and any vacancy thereby created may be filled by the vote of such holders. If and when such default shall cease to exist, the holders of the Series F Preferred Stock shall be divested of the foregoing special voting rights, subject to revesting in the event of each and every subsequent like default in payments of dividends. Upon the termination of the foregoing special voting rights, the terms of office of all persons who may have been elected directors pursuant to said special voting rights shall forthwith terminate, and the number of directors constituting the Board of Director shall be reduced by two. The voting rights granted by this Section 3(c) shall be in addition to any other voting rights granted to the holders of the Series F Preferred Stock in this Section 3. (d) Except as provided herein, in Section 11 or by applicable law, holders of Series F Preferred Stock shall have no special voting rights and their consent shall not be required (except to the extent they are entitled to vote with holders of Common Stock as set forth herein) for authorizing or taking any corporate action. SECTION 4. Certain Restrictions. (a) Whenever quarterly dividends or other dividends or distributions payable on the Series F Preferred Stock as provided in Section 2 are in arrears, thereafter and until all accrued and unpaid dividends and distributions, whether or not declared, on shares of Series F Preferred Stock outstanding shall have been paid in full, the Corporation shall not (i) declare or pay dividends on, make any other distributions on, or redeem or purchase or otherwise acquire for consideration any shares of stock ranking junior (either as to dividends or upon liquidation, dissolution or winding up) to the Series F Preferred Stock; (ii) Declare or pay dividends on, or make any other distributions on any shares of stock ranking on a parity (either as to dividends or upon liquidation, dissolution or winding up) with the Series F Preferred Stock, except dividends paid ratably on the Series F Preferred Stock and all such parity stock on which dividends are payable or in arrears in proportion to the total amounts to which the holders of all such shares are then entitled; (iii) redeem or purchase or otherwise acquire for consideration shares of any stock ranking on a parity (either as to dividends or upon liquidation, dissolution or winding up) with the Series F Preferred Stock; provided that the Corporation may at any time redeem, purchase or otherwise acquire shares of any such parity stock in exchange for shares of any stock of the Corporation ranking junior (either as to dividends or upon dissolution, liquidation or winding up) to the Series F Preferred Stock; or 34 38 Exhibit 4.1 (iv) purchase or otherwise acquire for consideration any shares of Series F Preferred Stock, or any shares of stock ranking on a parity with the Series F Preferred Stock, except in accordance with a purchase offer made in writing or by publication (as determined by the Board of Directors) to all holders of such shares upon such terms as the Board of Directors, after consideration of the respective annual dividend rates and other relative rights and preferences of the respective series and classes, shall determine in good faith will result in fair and equitable treatment among the respective series or classes. (b) The Corporation shall not permit any subsidiary of the Corporation to purchase or otherwise acquire for consideration any shares of stock of the Corporation unless the Corporation could, under paragraph (a) of this Section 4, purchase or otherwise acquire such shares at such time and in such manner. SECTION 5. Liquidation Rights. Upon the liquidation, dissolution or winding up of the Corporation, whether voluntary or involuntary, no distribution shall be made (1) to the holders of shares of stock ranking junior (either as to dividends or upon liquidation, dissolution or winding up) to the Series F Preferred Stock unless, prior thereto, the holders of shares of Series F Preferred Stock shall have received an amount equal to the accrued and unpaid dividends and distributions thereon, whether or not declared, to the date of such payment, plus an amount equal to the greater of (x) $.01 per whole share or (y) an aggregate amount per share equal to the Formula Number then in effect times the aggregate amount to be distributed per share to holders of Common Stock or (2) to the holders of stock ranking on a parity (either as to dividends or upon liquidation, dissolution or winding up) with the Series F Preferred Stock, except distributions made ratably on the Series F Preferred Stock and all other such parity stock in proportion to the total amounts to which the holders of all such shares are entitled upon such liquidation, dissolution or winding up. SECTION 6. Consolidation, Merger, etc. In case the Corporation shall enter into any consolidation, merger, combination or other transaction in which the shares of Common Stock are exchanged for or changed into other stock or securities, cash or any other property, then in any such case the then outstanding shares of Series F Preferred Stock shall at the same time be similarly exchanged or changed into an amount per share equal to the Formula Number then in effect times the aggregate amount of stock, securities, cash or any other property (payable in kind), as the case may be, into which or for which each share of Common Stock is exchanged or changed. In the event both this Section 6 and Section 2 appear to apply to a transaction, this Section 6 will control. SECTION 7. No Redemption; No Sinking Fund. (a) The shares of Series F Preferred Stock shall not be subject to redemption by the Corporation or at the option of any holder of Series F Preferred Stock except as set forth in the Certificate of Incorporation of the Corporation; provided, however, that the Corporation may purchase or otherwise acquire outstanding shares of Series F Preferred Stock in the open market or by offer to any holder or holders of shares of Series F Preferred Stock. (b) The shares of Series F Preferred Stock shall not be subject to or entitled to the operation of a retirement or sinking fund. 35 39 Exhibit 4.1 SECTION 8. Ranking. The Series F Preferred Stock shall rank junior to all other series of Preferred Stock of the Corporation, unless the Board of Directors shall specifically determine otherwise in fixing the powers, preferences and relative, participating, optional and other special rights of the shares of such series and the qualifications, limitations and restrictions thereof. SECTION 9. Fractional Shares. The Series F Preferred Stock shall be issuable upon exercise of the Rights issued pursuant to the Rights Agreement in whole shares or in any fraction of a share that is one one-thousandths (1/1,000ths) of a share of any integral multiple of such fraction which shall entitle the holder, in proportion to such holder's fractional shares, to receive dividends, exercise voting rights, participate in distributions and to have the benefit of all other rights of holders of Series F Preferred Stock. In lieu of fractional shares, the Corporation, prior to the first issuance of a share or a fraction of a share of Series F Preferred Stock, may elect (1) to make a cash payment as provided in the Rights Agreement for fractions of a share other than one one-thousandths (1/1,000ths) of a share or any integral multiple thereof or (2) to issue depository receipts evidencing such authorized fraction of a share of Series F Preferred Stock pursuant to an appropriate agreement between the Corporation and a depository selected by the Corporation; provided that such agreement shall provide that the holders of such depository receipts shall have all the rights, privileges and preferences to which they are entitled as holders of the Series F Preferred Stock. SECTION 10. Reacquired Shares. Any shares of Series F Preferred Stock purchased or otherwise acquired by the Corporation in any manner whatsoever shall be retired and canceled promptly after the acquisition thereof. All such shares shall upon their cancellation become authorized but unissued shares of Preferred Stock, without designation as to series until such shares are once more designated as part of a particular series by the Board of Directors pursuant to the provisions of Article Fifth of the Certificate of Incorporation. SECTION 11. Amendment. None of the powers, preferences and relative, participating, optional and other special rights of the Series F Preferred Stock as provided herein or in the Certificate of Incorporation shall be amended in any manner which would alter or change the powers, preferences, rights or privileges of the holders of Series F Preferred Stock so as to affect them adversely without the affirmative vote of the holders of at least 66-2/3% of the outstanding shares of Series F Preferred Stock, voting as a separate class; provided, however, that no such amendment approved by the holders of at least 66-2/3% of the outstanding shares of Series F Preferred Stock shall be deemed to apply to the powers, preferences, rights or privileges of any holder of shares of Series F Preferred Stock originally issued upon exercise of the Rights after the time of such approval without the approval of such holder. IN WITNESS WHEREOF, the Corporation has caused this Certificate to be duly executed in its corporate name on this day of _____________ 1995. Alteon Inc. By: Name: Title: 36 40 Exhibit 4.1 Attest: Name: Title: 37 41 Exhibit 4.1 EXHIBIT B [Form of Right Certificate] Certificate No. [R]- Rights --------------- NOT EXERCISABLE AFTER __________, 2005, OR EARLIER IF REDEEMED BY THE COMPANY. THE RIGHTS ARE SUBJECT TO REDEMPTION, AT THE OPTION OF THE COMPANY, AT $.01 PER RIGHT, ON THE TERMS SET FORTH IN THE STOCKHOLDERS RIGHTS AGREEMENT. RIGHTS BENEFICIALLY OWNED BY AN ACQUIRING PERSON OR AN AFFILIATE OR ASSOCIATE OF AN ACQUIRING PERSON (AS SUCH TERMS ARE DEFINED IN THE STOCKHOLDERS RIGHTS AGREEMENT) AND BY ANY SUBSEQUENT HOLDER OF SUCH RIGHTS ARE NULL AND VOID AND NONTRANSFERABLE. Right Certificate ALTEON INC. This certifies that , or registered assigns, is the registered owner of the number of Rights set forth above, each of which entitles the owner thereof, subject to the terms, provisions and conditions of the Stockholders Rights Agreement dated as of ____________, 1995 (the "Rights Agreement"), between Alteon Inc., a Delaware corporation (the "Company"), and Registrar and Transfer Company, as Rights Agent (the "Rights Agent"), unless the Rights evidenced hereby shall have been previously redeemed by the Company, to purchase from the Company at any time after the Distribution Date (as defined in the Rights Agreement) and prior to 5:00 p.m., New York City time, on the 10th anniversary of the date of the Rights Agreement (the "Expiration Date"), at the principal office of the Rights Agent, or its successors as Rights Agent, one one-thousandths (1/1,000ths) of a fully paid, nonassessable share of Series F Preferred Stock, par value $0.01 per share, of the Company (the "Preferred Shares"), at a purchase price per one one-thousandths (1/1,000ths) of a share equal to $80.00 (the "Purchase Price") payable in cash, upon presentation and surrender of this Right Certificate with the Form of Election to Purchase duly executed. The Purchase Price and the number and kind of shares which may be purchased upon exercise of each Right evidenced by this Right Certificate, as set forth above, are the Purchase Price and the number and kind of shares which may be so purchased as of [ ]. As provided in the Rights Agreement, the Purchase Price and the number and kind of shares which may be purchased upon the exercise of each Right evidenced by this Right Certificate are subject to modification and adjustment upon the happening of certain events. If the Rights evidenced by this Right Certificate are at any time beneficially owned by an Acquiring Person or an Affiliate or Associate of an Acquiring Person (as such terms are defined in the Rights Agreement), such Rights shall be null and void and nontransferable and the holder of any such Right (including any purported transferee or subsequent holder) shall not have any right to exercise or transfer any such Right. 38 42 Exhibit 4.1 This Right Certificate is subject to all the terms, provisions and conditions of the Rights Agreement, which terms, provisions and conditions are hereby incorporated herein by reference and made a part hereof and to which reference to the Rights Agreement is hereby made for a full description of the rights, limitations of rights, obligations, duties and immunities hereunder of the Rights Agent, the Company and the holders of the Right Certificates. Copies of the Rights Agreement are on file at the above-mentioned office of the Rights Agent and are also available from the Company upon written request. This Right Certificate, with or without other Right Certificates, upon surrender at the principal stock transfer or corporate trust office of the Rights Agent, may be exchanged for another Right Certificate or Right Certificates of like tenor and date evidencing Rights entitling the holder to purchase a like aggregate number and kind of shares as the Rights evidenced by the Right Certificate or Right Certificates surrendered shall have entitled such holder to purchase. If this Right Certificate shall be exercised in part, the holder shall be entitled to receive upon surrender hereof another Right Certificate or Right Certificates for the number of whole Rights not exercised. Subject to the provisions of the Rights Agreement, the Rights evidenced by this Right Certificate may be redeemed by the Company at its option at a redemption price (in cash or shares of Common Stock or other securities of the Company deemed by the Board of Directors to be at least equivalent in value) of $.01 per Right (which amount shall be subject to adjustment as provided in the Rights Agreement) at any time prior to the earlier of (i) such time as a Person becomes an Acquiring Person and (ii) the Expiration Date; provided, however, that, for the 120-day period after any date of a change (resulting from a proxy or consent solicitation) in a majority of the Board of Directors of the Company in office at the commencement of such solicitation, the Rights may only be redeemed if (A) there are directors then in office who were in office at the commencement of such solicitation and (B) the Board of Directors of the Company, with the concurrence of a majority of such directors then in office, determines that such redemption is, in their judgment, in the best interests of the Company and its stockholders. The Company may, but shall not be required to, issue fractions of Preferred Shares or distribute certificates which evidence fractions of Preferred Shares upon the exercise of any Right or Rights evidenced hereby. In lieu of issuing fractional shares, the Company may elect to make a cash payment as provided in the Rights Agreement for fractions of a share other than one one-thousandths (1/1,000ths) of a share or any integral multiple thereof or to issue certificates or utilize a depository arrangement as provided in the terms of the Rights Agreement and the Preferred Shares. No holder of this Right Certificate shall be entitled to vote or receive dividends or be deemed for any purpose the holder of the Preferred Shares or of any other securities of the Company which may at any time be issuable on the exercise hereof, nor shall anything contained in the Rights Agreement or herein be construed to confer upon the holder thereof, as such, any of the rights of a stockholder of the Company, including, without limitation, any right to vote for the election of directors or upon any matter submitted to stockholders at any meeting thereof, or to give or withhold consent to any corporate action, or to receive notice of meetings or other actions affecting stockholders (except as provided in the Rights Agreement), or to receive dividends or other distributions or subscription rights, or otherwise, until the Right or Rights evidenced by this Right Certificate shall have been exercised as provided in accordance with the provisions of the Rights Agreement. 39 43 Exhibit 4.1 This Right Certificate shall not be valid or obligatory for any purpose until it shall have been countersigned by the Rights Agent. WITNESS the facsimile signature of the proper officers of the Company and its corporate seal. Dated as of: ALTEON INC., By: -------------------------- Name: Title: Attest: Name: Title: Countersigned: Registrar and Transfer Company as Rights Agent, By: ------------------------------ Authorized Officer 40 44 Exhibit 4.1 [On Reverse Side of Right Certificate] FORM OF ELECTION TO PURCHASE (To be executed by the registered holder if such holder desires to exercise the Rights represented by this Right Certificate.) To the Rights Agent: The undersigned hereby irrevocably elects to exercise Rights represented by this Right Certificate to purchase the Preferred Shares (or other shares) issuable upon the exercise of such Rights and requests that certificates for such shares be issued in the name of: Please insert social security or other identifying number (Please print name and address) If such number of Rights shall not be all the Rights evidenced by this Right Certificate, a new Right Certificate for the balance remaining of such Rights shall be registered in the name of and delivered to: Please insert social security or other identifying number (Please print name and address) Dated: , 19 ------------------ --- Signature Signature Guaranteed: NOTICE 41 45 Exhibit 4.1 The signature on the foregoing Form of Election to Purchase must correspond to the name as written upon the face of this Right Certificate in every particular, without alteration or enlargement or any change whatsoever. 42 EX-10.8 5 w46067ex10-8.txt LEASE AGREEMENT DATED JANUARY 11, 1993 1 Exhibit 10.8 TABLE OF CONTENTS 170 WILLIAMS ASSOCIATES ALTEON INC.
CLAUSE PAGE Preamble 1 1. Premises 3 2. Term 3 3. Construction 4 4. Landlord's Financing 6 5. Rental 6 6. Use 7 7. Insurance 8 8. Increase of Insurance Rates 9 9. Fire and Other Casualty 9 10. Repairs and Maintenance 10 11. Covenants Against Liens 11 12. Alterations 12 13. Condemnation 12 14. Access and Right to Exhibit 13 15. Assignment and Subletting 14 16. Rules and Regulations, Compliance with Laws 15 17. Utilities 16 18. Signs 16 19. Taxes 17 20. Additional Charges 18 21. Non-Liability of Landlord 19 22. Intentionally Omitted 20 23. Right to Cure Default 20 24. Remedies Upon Default 20 25. Waiver of Redemption 22 26. Mortgage Priority 22 27. Surrender of Premises 23 28. Unavoidable Delays 23 29. Landlord Consent 24 30. Escrow for Fit-Up 24 31. Certification 25 32. Waiver of Trail by Jury 25 33. Quiet Enjoyment 25 34. Landlord 26 35. Notices 26 36. Covenants, Effect of Waiver 26 37. Holding Over 27 38. Reference 27 39. Entire Agreement 27 40. Attornment 27 41. Real Estate Broker 28 42. Validity of Lease 28 43. Common Areas 28 44. Representations 28 45. ECRA and Environmental Laws 28 46. Option to Renew 30 47. Cancellation Option 31 48. Expansion 31 49. Environmental Survey 32 50. Non-Binding Nature of Submittal 32
1 2 Exhibit 10.8 AGREEMENT OF LEASE PREAMBLE The Landlord and Tenant agree to the leasing of the premises indicated on the terms and conditions specified and agree that the following terms whenever used in this Lease shall have the meanings indicated unless the terms are otherwise expressly modified, limited or expanded herein. (1) LANDLORD: 170 Williams Associates, a New Jersey General Partnership ADDRESS: 500 Route 17 South, Hasbrouck Heights, NJ 07604 (2) TENANT: Alteon Inc. ADDRESS: 165 Ludlow Avenue, Northvale, NJ 07647 (3) DATE OF LEASE: January 3, 1993 (4) LEASED PREMISES: Land and Building as shown on Exhibits A&B ADDRESS:170 Williams Drive, Ramsey, NJ DESCRIPTION: As Shown on Exhibits A & B TERM: Ten (10) Years COMMENCEMENT DATE OF TERM: November 1, 1993 TERMINATION DATE: October 31, 2003 (6) APPROXIMATE SIZE OF BUILDING: 37,000 Sq. Ft. (7) BASE RENT: COMMENCEMENT DATE BASE RENT: November 1, 1993 TOTAL LEASE BASE RENTAL: $4,815,874.68 ANNUAL BASE RENTAL: Year 1 : $296,833.32 Year 2 : $321,854.16 Year 3 : $441,687.48 Years 4-10: $536,499.96
MONTHLY BASE RENTAL: Months 1- 18 : $24,736.11 per Month Months 19- 30: $28,906.25 per Month Months 31-120: $44,708.33 per Month
RENT DUE DATE: First of Month (8) ESCROW FOR FIT-UP: $1,034,000.00 (9) TENANT'S ALLOCABLE PERCENTAGE: 100 % (10) ESTIMATED ADDITIONAL MONTHLY RENTAL CHARGE: $3,533.00(Taxes & Ins.) (11) PERMITTED USE: General offices, warehouse and pharmaceutical development laboratories includinq animal testing. (12) INSURANCE REQUIREMENTS: LANDLORD: Per Paragraph 20 TENANT: Per Paragraph 7 (13) BROKER: Edward S. Gordon company of New Jersey Inc. (14) TAX IDENTIFICATION NO. -1- 3 Exhibit 10.8 LANDLORD: 22-2340277 TENANT: 13-3304550 (15) TENANT SIC NO: 8731 (16) EXHIBITS: A. Site Plan B. Existing Floor Plan C. Letter of Intent D. Form of Non-Disturbance Agreement -2- 4 Exhibit 10.8 W I T N E S S E T H: PREMISES. 1. The Landlord hereby leases to Tenant and Tenant hereby takes from Landlord, those certain premises, consisting of a building on land owned by Landlord (which building and land are collectively hereinafter referred to as the "Leased Premises") , located in the Borough of Ramsey, County of Bergen and State of New Jersey,and more particularly described on Exhibit "A" (the Land) and Exhibit B (the Building) attached hereto and made a part hereof, subject however, to all of the terms, covenants, provisions and conditions herein set forth and to all liens, encumbrances, conditions, rights, easements, restrictions, rights-of-way, covenants and zoning and building laws, ordinances, regulations and codes affecting or governing the Building or which may hereafter affect or govern the Building, and such matters as may be disclosed by inspection,provided the same do not impair or interfere with the use and enjoyment of the Leased Premises by Tenant for the purpose hereinafter stated in Paragraph 6. Landlord represents and warrants that all liens encumbrances, conditions, rights, easements, restrictions, rights-of-way and covenants and agreements do not interfere with the use and enjoyment of the Leased Premises. TO HAVE AND TO HOLD the Premises for the term and at the rents herein set forth together with the right to use the driveway on Lot 13 which is adjacent to the Leased Premises for ingress and egress. TERM. 2. (a) The Term of this lease (hereinafter referred to as "Term") shall be for the period stated following the Commencement Date, as hereinafter defined, unless sooner terminated as herein expressly provided. In the event however, that the Commencement Date is not the first day of a month, then the Term shall end on the last day of the month in which the anniversary of the Commencement Date shall fall. (b) The term, and the Tenant's obligation to pay Rental and Additional Rental, as hereinafter defined, shall commence on the earlier of the following dates (which date is hereinafter referred to as the "Commencement Date"): (1) On November 1, 1993 or (2) the date on which Tenant shall first conduct any business activities on the Premises provided Landlord has completed all of the work it is required to do by Paragraph 3 (a) by November 1, 1993 and tendered possession of the Premises to Tenant for Tenant to begin its Tenants Work (as hereinafter defined) on or prior to February 1, 1993 (February 1, 1993 is hereinafter referred to as "Possession Date"). If Tenant utilizes any of the space in the Building prior to November 1, 1993 for its regular business activities, it shall pay the Landlord on a monthly basis a pro rata portion of the Total Lease Base Rental and estimated Additional Rent which shall be determined by dividing the space so occupied by 37,000 and multiplying the result by $45,373.96. In the event of such pre-Term occupancy for such regular business activities, all of the other terms and conditions of this Lease shall apply to Tenant's use and occupancy of the Leased Premises. (c) For purposes of this lease, a "Lease Year" shall be deemed to be each consecutive period of twelve (12) full calendar months during the Term hereof, except that the first Lease Year shall also include the fractional portion of the month, if any, immediately following the Commencement Date, and that the last Lease Year shall run only from the day following the termination of the previous Lease Year to the termination 67 date of the lease. -3- 5 Exhibit 10.8 CONSTRUCTION. 3. (a) The premises are being leased by Tenant on an as-is basis except as otherwise indicated herein. Landlord shall, at its sole cost and expense, complete the following building improvements prior to Tenant's occupancy: (i) Furnish and install, at the election of Tenant, one (1) of the following elevators: (a) one (1) twin jack, holeless, hydraulic freight elevator approximately 6'4" x 8'2", 4000 lb. capacity, speed 75 fpm, two (2) stops in-line, with 6'x 7' bi-parting manual gates as manufactured by Casper Elevator Company or equal; or (b) one (1) single jack, holeless, hydraulic passenger elevator approximately 7'X 6', 3000 lb. capacity (20 people), 100 with a 3' 0" wide door as manufactured by Dover Elevator Company or equal; or (c) 4500 lb. hydraulic with interior dimensions of 5'8" x 7'11" manufactured by Otis Elevator or Dover Elevator or equal subject to the approval of Tenant's Architect; (ii) Furnish and install windows into the portion of the lower floor which is above grade and four (4) windows in the rear wall of the second floor. Such windows to be of equal quality to those presently installed on the upper floor. Landlord shall submit shop drawings for such windows to the Tenant's architect for the architect's reasonable approval which shall not be unreasonably withheld or delayed; (iii) Furnish and install screening on the roof to screen the HVAC equipment from view at the front approach to the building. Screening to be aesthetically and structurally consistent with the quality and style of the building; (iv) Landlord shall investigate the possibility of water leakage into the first floor and, if required, perform any necessary corrective measures in a manner subject to the reasonable approval of Tenant and/or its architect/engineer; (b) The Tenant shall complete all other improvements within the Building required for its occupancy (hereinafter referred to as "Tenant's Work"), in accordance with plans to be prepared by the Grad Partnership, Tenant's architect (hereinafter referred to as "Tenant's Plans"). Tenant's Plans shall be subject to the prior written approval of Landlord, which approval shall not be unreasonably withheld or unduly delayed. The Landlord shall provide an allowance of $1.50 per rentable square foot towards the costs of Tenants Plans. This drawing allowance shall be paid to Tenant twenty (20) days following the later of : (1) the date of drawing completion or (2) the start of construction of Tenant improvements. All costs involved in Tenant's work (including, but not limited to permits, professional fees, cost of utilities, interest costs to Landlord for all sums paid by Landlord to Tenant as hereinafter provided and all improvements costs) (herein referred to as "Tenant Construction Costs") are the responsibility of the Tenant. Landlord will reimburse Tenant, for a portion of all Tenant Construction Costs, the amount of Nine Hundred Seventy Eight Thousand Five Hundred ($978,500.00) Dollars (hereinafter referred to as the "Landlord's Allowance") as hereinafter provided in Sub-paragraph 3 (c) and 3 (d). Tenant has the right to seek competitive bids for the performance of Tenants Work as well as future alterations during the Lease Term so long as the contractor and subcontractors selected are acceptable to Landlord, which acceptance shall not be unreasonably withheld or delayed. In the event a contractor other than an affiliate of Landlord is selected, Tenant shall pay to Landlord a supervisory fee which shall be limited to actual and reasonable costs for personnel and materials. (c) A portion of Landlord's Allowance, in an amount not to exceed Eight Hundred Seventy Eight Thousand Five Hundred ($878,500.00) Dollars, shall be paid in progress payments to Tenant during the progress of Tenant's performance of Tenant's Work upon the written request of Tenant, which request shall be accompanied by the following: -4- 6 Exhibit 10.8 (i) A Certificate signed by the architect or engineer in charge of Tenant's Work, reasonably satisfactory to Landlord and any construction lender supplying the funds, dated not more than five (5) days prior to such request, setting forth the following: (A) That the sum then requested has been or is to be paid by Tenant to contractors, subcontractors, materialmen, engineers, architects or other persons who have rendered services or furnished materials in connection with Tenant's Work therein specified, and giving a brief description of such services and materials and the several amounts so paid to each of said persons in respect thereof, and stating that no part of such expenditures has been or is being made the basis in any previous or then pending request for the withdrawal or has been previously made, and that the sum then requested does not exceed the value of the services and materials described in the certificate. (B) That, except for the amount, if any, stated pursuant to the foregoing subparagraph (A) in such certificate to be due for services or materials, there is no outstanding indebtedness which is then due for labor, wages, materials, supplies or services in connection with Tenant's Work and which, if unpaid, might become the basis of a vendor's mechanic's, laborer's or materialmen's statutory or similar lien upon the Premises, or any part thereof, or upon Tenant's leasehold interest therein (unless such lien is adequately bonded or insured against by a surety company bond or title policy free and clear of liens, by a company and in form, substance and amount reasonably satisfactory to Landlord). (ii) Progress payments shall be made to Tenant in accordance with the reasonable requirements of First Fidelity, not later than thirty (30) days after Landlord's receipt of Tenant's written request for the Landlord's Allowance funds. (iii) A copy of Tenant's general contract with its general contractor and copies of any Change orders (as hereinafter defined) since the prior progress payment. The term "Change Orders" shall mean any written and signed amendments or modifications to Tenant's plans or general contract with its contractor. (iv) Such other documentation, affidavits and certificates as are required by Landlord's construction or permanent lender; it being specifically understood that Landlord is receiving funds from its construction or permanent lender in order to reimburse Tenant. (d) The remaining One Hundred Thousand ($100,000.00) Dollars of the Landlord's Allowance shall be paid to Tenant subsequent to the Commencement Date and upon Landlord's receipt from Tenant of (a) a copy of the final certificate of occupancy for the Premises, and (b) a written certificate from Tenant's architect certifying that Tenant's Work has been completed in accordance with Tenant's Plans. Tenant shall give Landlord written notification of completion and Landlord shall have a reasonable time within which to inspect the Tenant's Work and either approve or disapprove same. Landlord's approval shall not be unreasonably withheld if Tenant's Work shall be performed in accordance with Tenant's Plans, as approved by Landlord. If Landlord disapproves the Tenant's Work or any portion thereof, Tenant shall promptly cause any defects noted by Landlord in Tenants Work to be corrected. Promptly upon completion of the -5- 7 Exhibit 10.8 Tenant's Work, Tenant shall furnish Landlord with an affidavit, in form reasonably satisfactory to Landlord's counsel, from Tenant's general contractor stating that all subcontractors, laborers and material suppliers who have supplied labor and/or materials in connection with the Tenant's Work have been paid in full and that the general contractor releases any and all liens with respect to labor and materials supplied to the Premises for the Tenant's Work. Landlord agrees to pay to Tenant the remaining one Hundred Thousand ($100,000.00) Dollars of the Landlord's Allowance within fifteen (15) days after Tenant shall have provided Landlord with all of the items required by this sub-paragraph (b). Any and all of Tenant's costs to construct the Tenant's Work exceeding the allowance stated in sub-paragraph (b) shall be borne by Tenant. (e) All Construction shall be in a good and workmanlike manner and shall be in compliance with all applicable laws, ordinances, rules and regulations of any duly constituted governmental authority having jurisdiction thereof. (f) If the Tenant Work is not substantially completed by November 11, 1993 due to (1) the non-performance by the Landlord of its obligations under 3.(a)(i)-(iv) above; (2) Landlord's failure to tender possession of the Premises to Tenant on or before February 1, 1993; (3) any other delay attributable to or caused by Landlord's acts or omission or those of any of its employees, agents, contractors or invitees; or (4) Tenant's inability to obtain a Certificate of Occupancy because of a pre existing condition, then the Commencement Date shall be postponed one (1) day for each day the completion of Tenant improvements is delayed beyond November 1, 1993 due to the foregoing items (1) through (4). (g) In addition to "Landlords Allowance" Landlord shall provide an Additional Tenant Improvements Allowance in the amount of $26,750.00 per month for each month (which shall be prorated for any partial month) subsequent to the commencement of the Lease and up to and ending the month of June 1994 (hereafter referred to as "Additional Tenant Improvements Allowance"). Landlord shall pay to the Tenant the Additional Tenant Improvements Allowance no later than the tenth (10th) day of each month following the Commencement Date through and including June 1, 1994. LANDLORDS' FINANCING. 4. Landlord has received a Letter of Intent from First Fidelity Bank, N.A. ("First Fidelity") which is attached hereto as Exhibit "C". This Lease is contingent upon Landlords receipt and its acceptance of a formal written mortgage commitment to the Landlord embodying the terms of the Letter except with respect to the use of the Security to be posted by the Tenant, which commitment shall embody in substance the provisions of Paragraph 30. If Landlord has not received the commitment on or before January 22, 1993 and so advised the Tenant in writing or if the Landlord has not accepted the commitment on or before January 29, 1993 and so advised the Tenant in writing, then this Lease shall be terminated and neither party shall have any claim against the other except that the Landlord shall return to the Tenant the first months rent paid by the Tenant to the Landlord pursuant to Paragraphs 5.(a)(i). RENTAL. 5. (a) Tenant covenants and agrees to pay to the Landlord the following Rental: (i) a base rent during the Term of this lease or any extension as may be provided for herein (hereinafter called the "Base Rent") in the sum stated in the Preamble payable by Tenant in equal monthly installments as stated on or before the first day of each month, in advance, to Landlord at the office of Landlord above designated or to such other place as shall be -6- 8 Exhibit 10.8 designated by Landlord, without any prior notice or demand therefor And without any deduction, abatement or set off for any reason Whatsoever, except that the first month's rent, shall be paid upon the execution of the Lease by Tenant; (ii) All charges payable pursuant to this lease As additional rental (hereinafter referred to as "Additional Rental"); (iii) In the event that the Commencement Date Shall be other than the first day of a month, then the Tenant shall be given a credit by the Landlord for the fractional portion of the first month of the Lease Term prior to the Commencement Date on a per diem basis (calculated on the basis of a thirty-day month) for Base Rent and Additional Rent paid by Tenant for such period. Such credit shall be calculated by Landlord and issued to Tenant to be used as a credit against a portion of the next months rent due. Such Base Rent and Additional Rental are herein Referred to collectively as "Rental" (b) It is intended that the Rental provided for in this lease shall be a net return to Landlord throughout the Term Hereof, free of any expense, charge or other deduction whatsoever, with respect to the Premises, the Building and/or the operation, management, maintenance, repair, use or occupation thereof, or any Portion thereof, with respect to any interest of Landlord therein, except only as otherwise expressly provided in this lease. Any attempt by Tenant "to escrow: any rent due or similar self-help Shall constitute a default. (c) In the event that any payment of Rental due Hereunder is not made on the date it is due, a late charge in the amount of five percent (5%) for each dollar so overdue may be charged by the Landlord for each month or part thereof that the same remains overdue. This charge shall be in addition to and not in lieu of any other remedy the Landlord may have under the circumstances and is in addition to any reasonable fees and charges of any agents or attorneys Landlord may employ as a result of any default in the payment of Rental hereunder, whether authorized herein or by law. Any such "late charges" if not previously paid shall, at the option of the Landlord, be added to and become part of the succeeding rental payment to be made hereunder and shall be deemed to constitute additional Rental. USE 6. the Premises are to be used by Tenant for any permitted use, subject to and in accordance with all rules, regulations, laws, ordinances and requirements of all governmental authorities, the Fire Insurance Rating Organizations and Boards of Fire Insurance Underwriters, and any similar bodies having jurisdiction thereof, and for no other purpose. Landlord represents that Tenants proposed use set forth in Paragraph II of the Preamble is a permitted use in the Leased Premises under the applicable zoning, health, fire, building, environmental and all other governmental regulations. Landlord represents and warrants to Tenant that, at the commencement Date, the Premises shall be in compliance with all applicable governmental laws, orders, regulations and codes (collectively the "laws") applicable to the Premises including without limitation building, zoning, environmental and health laws and the Americans with Disabilities Act; that the Premises do not violate and Landlord has received no notice of any violations, of any such laws and that all taxes have been paid to date; and that Landlord knows of no pending -7- 9 Exhibit 10.8 assessments or liens on the Premises. INSURANCE. 7. (a) Tenant shall provide, on or before the earlier of Tenant's entry in the Premises or the Commencement Date, and keep in force, at all times during the Term, at its sole cost and expense, a comprehensive public liability insurance policy, in the names of and for the mutual benefit of Landlord and any of its designees (without any obligation to pay premium) and Tenant, insuring the Landlord and Tenant against any claim or liability for personal injury to or death of any persons, and/or damage to property occurring in, on or about the Premises, or any appurtenances thereto. Such policy shall contain a "Landlord Protective Liability" endorsement and shall provide for limits of liability thereunder of not less than One Million ($1,000,000.00) Dollars in respect to personal injury or death to any one person, One Million ($1,000,000.00) Dollars in respect to personal injury or death to any number of persons and Five Hundred Thousand ($500,000.00) Dollars in respect to property damage. The limit of any such insurance shall not limit the liability of the Tenant hereunder. (b) Landlord agrees to obtain and keep in full force and effect, at all times during the Term, at Tenant's sole cost and expense, policies of insurance covering the Building and improvements made by the Landlord to the Premises against all risks to physical damage with extended coverage, in amounts equal to the full replacement value of such improvements, without any co insurance; rental insurance sufficient to include both Base and Additional Rental; and such other insurance coverages as Landlord may deem necessary or proper, all of which insurance coverages shall be in such amounts and with such companies as Landlord may deem reasonable and proper. The cost of any such insurance shall be paid as Additional Rental pursuant to Paragraph 20 hereof. (c) Landlord shall not provide any insurance covering the Tenant's possessions or business operations. Tenant agrees to obtain, at its sole cost and expense, an insurance policy covering its contents and a liability policy covering its business operations which shall include contractual liability. (d) Landlord and Tenant agree that the insurance policies to be obtained hereunder shall provide that the insurance carriers shall waive all rights of subrogation against Landlord and Tenant and that such policies shall not be invalidated should the insurance waive in writing prior to a loss any or all right of recovery against any party for losses covered by such policies. Landlord and Tenant hereby waive and release any and all right of recovery which it might otherwise have against the other, their agents and employees, for all injury and for loss or damage to its business, contents, furniture, furnishings, fixtures and other property of the Landlord or Tenant, notwithstanding that such injury, loss or damage may result from the negligence or fault of Landlord or Tenant, their agents, or employees, provided that no such waiver or release shall operate to invalidate any insurance coverage. (e) Tenant agrees to deliver to Landlord, at least fifteen (15) days prior to the time such insurance is first required to be carried by Tenant, and thereafter at least fifteen (15) days prior to the expiration of any such policy, either a duplicate original or a certificate of insurance and a true copy of all policies procured by Tenant in compliance with its obligations hereunder, together with evidence of payment therefor. All such policies shall provide for notice of cancellation to be provided thirty (30) days prior to any cancellation. INCREASE OF INSURANCE RATES. 8. Tenant agrees, at its sole cost and expense, to -8- 10 Exhibit 10.8 promptly comply with all of the rules and regulations of the Insurance Service Organization of New Jersey having jurisdiction, or any similar body. If, at any time, as a result of or in connection with any failure by Tenant to comply with the foregoing provision, or as a result of any act or omission or commission by Tenant, its employees, agents, contractors, invitees, licensees or subtenants, or as a result of or in connection with the use to which the Premises are put, notwithstanding that such use may be for the purpose herein permitted or that such use may have been consented to by Landlord, any insurance rate applicable to the Building and/or to the contents thereof, shall be higher than that which would be applicable for the least hazardous types of occupancy legally permitted therein, then and in any of such events, Landlord shall have the right to treat as additional rent, the added premium if Tenant fails to cease the conduct causing such increase within thirty (30) days of notice from Landlord. Tenant shall not use nor install any electrical equipment that overloads the lines in the Building and Tenant, at its sole cost and expense, shall promptly make whatever changes are necessary to prevent or remedy such condition and to comply with all requirements of Landlord, the Board of Fire Insurance Underwriters or any similar body and any governmental authority having jurisdiction thereof. For the purposes of this Paragraph, any finding or schedule of the Fire Insurance Rating organization or any similar organization having jurisdiction shall be deemed to be conclusively binding on the parties hereto. FIRE AND OTHER CASUALTY. 9. (a) In case of fire or other casualty, Tenant shall give immediate notice to Landlord. In the event the Premises shall be partially damaged by fire, the elements or other casualty, but shall not be so destroyed or damaged as to substantially impaired the ongoing conduct of Tenant's business, then the Landlord shall repair the same within ninety (90) days of such casualty to the extent of the scope of Landlord's work in the original construction of the Premises, and if any portion of the Premises shall be rendered untenantable, then the Tenant's obligation to pay Rental hereunder shall abate in the same proportion which the square footage of the portion rendered untenantable bears to the total square footage of the Premises until such time as the Landlord shall have substantially repaired the Premises. In the event that through no fault of the Tenant, its agents, servants, employees, contractors or invitees, the Tenant's use of the Premises is substantially impaired and, the Landlord does not give notice to the Tenant within thirty (30) days of the fire or other casualty that the Premises will be restored and the Tenant's use will not be substantially impaired except as to the replacement of Tenant's fixtures, laboratory and/or other personal property within one hundred twenty (120) days of the date of the notice, or if the Premises are not substantially restored and the Tenant's use will not be substantially impaired except as to the replacement of Tenant's fixtures, laboratory and/or other personal property during such one hundred twenty (120) day period, the Tenant shall have the right to terminate this Lease on thirty (30) days written notice delivered to Landlord. In the event the Landlord elects to restore the Premises as stated, then the lease shall remain in full force and effect, the Rental payments shall be reduced as aforesaid, and the Landlord shall proceed diligently to rebuild the Building and/or to restore the Premises. (b) However, there shall not be any abatement, reduction or moratorium of rent if the fire or other casualty or damage shall be the result of gross negligence or improper conduct of of Tenant or its agents, employees, guests, licensees, invitees, subtenants, assignees or successors. In any such case, Tenant's liability for the payment of the Rental and the performance of all the covenants, conditions and terms hereof on its part to be performed shall continue and Tenant shall be liable to Landlord for the damage or loss suffered by Landlord. If Tenant shall have been insured against any of the risks herein covered, then the proceeds of such insurance shall be paid over to Landlord to the extent of Landlord's costs and expenses and for any other damage or loss -9- 11 Exhibit 10.8 suffered by Landlord as a result of such casualty. (c) For purposes of determining substantial imparement,the Landlord and Tenant agree that a casualty shall include a material violation of any Environmental Law (as hereinafter defined) and as the obligations are assumed pursuant to Paragraph 45. REPAIRS AND MAINTENANCE. 10. (a) Except as provided in Paragraph 10(c) hereof, Tenant, at its sole cost and expense, shall (1) maintain and repair the structural portions (as hereinafter defined) of the Premises, (2) maintain, repair, and replace each and every other part of the Leased Premises including, without limitation, painting and decorating and the heating, ventilating, plumbing, electrical, sprinkler, elevator and air conditioning units or systems in the Building, and (3) shall not cause nor permit any dirt, debris or rubbish to be put, placed or maintained on the sidewalks, driveways, parking lots, yards, entrances and curbs, in, on or adjacent to the Building. Tenant further agrees not to use the Premises or permit the Premises to be used in any manner as to cause excessive depreciation of or to the Building and improvements,and agrees not to cause nor permit waste of or damage or nuisance to, in, or about the Premises or the Building. (b) Tenant shall not make any alterations, improvements, and/or additions to the Premises or any part thereof exceeding $25,000.00 (non structural), nor install or attach any heavy equipment or apparatus, without Landlord's prior consent which consent shall not be unreasonably withheld or delayed in accordance with the provisions of this lease. (c) Landlord, upon reasonable notice from Tenant and provided further that Landlord cannot repair same, shall make, at Landlords cost and expense, necessary replacements to the structural portion of the Premises, excluding, however, all windows, doors, plate glass, signs which shall be maintained, repaired and replaced by the Tenant and all repairs required by any casualty except as otherwise provided in Paragraph 9 and 13 hereof. For the purpose of this lease, "structural" shall be defined as the steel, footings, foundations, masonry walls, elevators, roof and floors of the Leased Premises. Landlord shall also repair or replace any condition in the Leased Premises required to be repaired or replaced by any agency of the Borough of Ramsey which is discovered during the completion of Tenant's work which relates to a condition in the Leased Premises which should have been repaired or replaced prior to the commencement of Tenant's Work as a part of the Landlord obtaining the Certificate of Continued Occupancy which the Landlord has delivered to the Tenant. Any repairs, whether structural or otherwise, resulting from damage caused by any act, omission or negligence of Tenant, any subtenant or concessionaire, or their respective employees, agents, invitees, licensees or contractors shall be performed by the Landlord at the sole cost and expense of the Tenant and shall be deemed to constitute Additional Rental. (d) Tenant further agrees to maintain, repair, secure, and keep in good order and condition, reasonably clean and free from snow, dirt and rubbish, all public or common areas surrounding the Building which are the property of the Landlord, except as otherwise herein provided, and agrees to furnish all necessary utilities to such public or common areas. The costs and expenses incurred by Tenant for maintenance, repairs, utilities, janitorial service, refuse and snow removal and security of the public or common areas shall be determined in the sole discretion of Tenant, to ensure the proper quality and the preservation of the reputation of the Building. Tenant may elect to have the Landlord undertake Tenants responsibilities under this sub-paragraph 10 (d) by so advising the Landlord sixty (60) days in advance of the date that Tenant wishes the Landlord to do so. In that event, the Tenant shall pay all reasonable costs and expenses so incurred by -10- 12 Exhibit 10.8 Landlord, as Additional Rental, in accordance with the provisions of Paragraph 20 hereof. (e) Tenant shall have the right of access to the roof of the Building and to install, repair, place or replace any aerial, fan, air conditioner or other device on the roof of the Building without the prior written consent of Landlord. Tenant shall repair at Tenant's expense, any damage to the Building or roof resulting from the installation, repair, use, or replacement of any such air conditioner or other device. COVENANTS AGAINST LIENS. 11. (a) Tenant shall not do any act, nor make any contract which may create any lien or other encumbrance upon the Building or Premises, nor permit nor suffer same to remain, as a result of any labor, work, services or materials performed, supplied or furnished for or to the Tenant or the Premises. If, because of any act or omission (or alleged act or omission) of Tenant, any mechanic's or other lien or encumbrance shall be filed against the Building or Premises, whether or not such lien or encumbrance is valid or enforceable as such, Tenant, at its sole cost and expense, shall cause same to be discharged of record or bonded, within thirty (30) days after notice to Tenant of the filing thereof; and Tenant shall indemnify and save harmless Landlord against and from all damages, costs, liabilities, suits, penalties, claims and demands, including reasonable counsel fees, resulting from the creation of such lien or encumbrance. In the event Tenant fails to so comply, Landlord shall have the option of discharging or bonding any such lien or encumbrance, and Tenant agrees to reimburse Landlord for all costs, legal and other expenses incurred in connection therewith, together with interest at an annual rate equal to two (2%) percent above the annual interest rate extended by Citicorp to its most favored borrowers, promptly upon demand, which sums shall be deemed to constitute Additional Rental. All materialmen, contractors, artisans, mechanics, laborers and any other persons now or hereafter contracted by Tenant for the furnishing of any labor, services, materials, supplies or equipment, at any time from the date hereof until the end of the Term, are hereby charged with notice that they must look exclusively to Tenant to obtain payment for same. (b) Nothing in this lease shall be deemed to be, or construed in any way as constituting, the consent or request of Landlord, expressed or implied, by inference or otherwise, to any person, firm or corporation for the performance of any labor or the furnishing of any materials for any construction, rebuilding, alteration, addition or repair of or to the Premises or any part thereof, nor as giving Tenant any right, power or authority to contract for or permit the rendering of any services or the furnishing of any materials which might in any way give rise to the right to file any lien against Landlord's interest in the Building. Landlord shall have the right to post and keep posted at all reasonable times on the Premises any notice which Landlord shall deem necessary so to post for the protection of Landlord and the Building from any such lien. ALTERATIONS. 12. (a) Tenant shall not make, or cause, or permit the making of any repairs, alterations, additions, or improvements in or to the Premises without obtaining Landlord's prior written consent thereto in each instance. In the event any such work shall cost in excess of Twenty Five Thousand ($25,000.00) Dollars, such work shall not be commenced until Tenant shall submit to the Landlord plans and specifications relating to any such repairs, alterations, additions or improvements, and all such work shall be -11- 13 Exhibit 10.8 performed in accordance with the provisions of this Lease. Landlord shall not unreasonably withhold its consent to any such alteration, addition or improvement, but shall have the right to determine if such work would reduce the value, size or general utility of the Building or any portion thereof, or whether such work maintains the architectural harmony of the Building. Any approval by Landlord as aforesaid may be upon condition that Tenant furnish the Landlord such evidence of Tenant's financial ability to assure completion thereof and payment therefore as Landlord may reasonably require, including the furnishing of adequate security. All such repairs, alterations, additions or improvements, not removed by Tenant at end of Term, shall belong to and become the property of the Landlord. Tenant shall have the right to remove all fixtures equipment, furnishings and Tenant Improvements not permanently affixed to the Building and all above standard and laboratory improvements (whether or not permanently affixed) approved by Landlord prior to the expiration or other termination of this Lease but shall repair all damage caused by such removal and restore the Premises to a condition suitable for painting (not necessarily "paint ready" as that term is commonly used) and carpeting (i.e. walls repaired and spackled, floors cleaned and holes repaired). Nothing herein contained shall be construed in any way to restrict Tenant's right to make any alterations, additions or improvements in Tenant's own movable trade fixtures. (b) Any work performed by Tenant, irrespective of cost, shall be subject to the Landlord's inspection and approval after completion to determine whether it complies with the requirements of this lease. The approval or consent of the Landlord shall not relieve Tenant of its obligation that all such repairs, alterations, improvements and/or additions be constructed and performed in a first-class good and workmanlike manner and in accordance with all applicable governmental and fire underwriting requirements, nor constitute a waiver of any rights of Landlord if Tenant fails to perform its obligations. Tenant, at its sole cost and expense, shall procure all necessary governmental approvals, permits or certificates in connection with all work performed by Tenant in, on or at the Premises and shall deliver the original of all such approvals, permits or certificates to the Landlord, to be retained by Landlord. (c) During the course of any and all repairs, alterations, additions or improvements which the Tenant shall either be required to perform or which the Tenant shall elect to perform Tenant, at its sole cost and expense, shall at all times obtain and maintain or cause to be obtained and maintained, workmen's compensation insurance and any other insurance which shall then be required by law, together with public liability insurance as set forth in Paragraph 7 hereof, to insure against any additional hazards created in connection with the performance of any of the aforesaid work. Prior to the commencement of any such work, Tenant shall deliver to Landlord copies of all policies or certificates of insurance with respect to all policies required pursuant to this Paragraph 12(c). CONDEMNATION. 13. (a) In the event that the whole of the Premises -12- 14 Exhibit 10.8 shall be taken for any public or quasi-public use under any statute or by right of eminent domain, or by private purchase in lieu thereof, then this lease shall automatically terminate as of the Date that title shall be taken. In the event that a part of the Premises shall be so taken as to render the remainder thereof unusable for the purpose for which the Premises are leased, then Landlord and Tenant shall each have the right to terminate this lease on thirty (30) days' written notice to the other, given within sixty (60) days following the date of such taking. In the event that this lease shall terminate or be terminated, the Rental hereunder shall be equitably adjusted as of the date of termination. (b) In the event that a part of the Premises shall be so taken and this lease shall not terminate or be terminated pursuant to the provisions of subparagraph (a) above, then the Rental shall be equitably apportioned according to the square footage of the Premises so taken and this lease, in all other respects, shall remain in full force and effect, and Landlord, at its own cost and expense, shall restore the remaining portion of the Premises in a manner substantially similar to the Building as it pre-existed the taking. If the Landlord does not complete the restoration within one hundred twenty (120)days of the physical taking, then and in that event, either the Landlord or the Tenant may terminate this Lease on thirty (30) days written notice to the extent necessary to render it reasonably suitable for the purpose for which the Premises were leased, provided that such work shall not exceed the scope of the work required to be done by Landlord in originally constructing the Premises and provided the cost thereof shall not exceed the proceeds of its condemnation award for consequential damages. (c) All compensation awarded or paid upon such a total or partial taking of the Building or the Premises shall belong to and be the property of Landlord, and without any sharing by Tenant, whether such compensation result from diminution in value of the leasehold or to the fee interest in the Premises. Tenant however, shall have the right to seek and prosecute any claim directly against the condemning authority in such condemnation proceedings for moving expenses, inventory and/or movable trade fixtures, Tenant's improvements beyond those paid for by the Landlord's Allowance, furniture and other personal property belonging to Tenant, so long as such claim shall not diminish or otherwise adversely affect Landlord's award or the award of any mortgagee. (d) Tenant agrees to execute and deliver such instruments as may be deemed necessary or required to expedite any condemnation proceedings or to effectuate a proper transfer of title to such governmental or other public authority, agency, body or public utility seeking to take or acquire the Premises or any portion thereof. Tenant covenants and agrees to vacate the Premises, remove all of its personal property therefrom and deliver up peaceable possession thereof to Landlord or to such other party designated by Landlord in the event of condemnation of the entire Premises. Failure by Tenant to comply with any provision hereof shall subject Tenant to such costs, expenses, damages and losses as Landlord may incur by reason of Tenant's breach hereof. ACCESS AND RIGHT TO EXHIBIT. 14. (a) Landlord and its designees shall have the right to enter upon the Premises at all reasonable hours upon twenty four (24) hours prior notice to Tenant (and in emergencies at all times): (i) to inspect the same; (ii) to make repairs, additions or alterations -13- 15 Exhibit 10.8 to and/or to complete initial construction of, the Premises and/or to the Building or to prevent waste or depreciation thereof; (iii) to post "For Sale" signs on the Premises at a location in the front of the building to be reasonably approved by Tenant and to exhibit the Premises to any prospective purchaser or mortgagee upon twenty four (24) hours prior notice to Tenant. This Paragraph shall not be deemed to be a covenant by Landlord nor be construed to create an obligation or duty on the part of Landlord to make such inspection, repairs, additions or alterations except as otherwise herein provided. Any performance by Landlord hereunder shall not be deemed a waiver of Tenant's default in failing to perform same, nor shall Landlord be liable for any reasonable and limited inconvenience, disturbance, loss of business, loss of use of the Premises, and the obligations of Tenant pursuant to this lease shall not thereby be affected in any manner whatsoever. Landlord agrees to exercise due care to cause the least reasonably possible interference with Tenant's business, but Landlord shall not be required to employ labor on weekends or on an overtime basis to avoid or reduce any such interference. (b) For a period commencing one hundred eighty (180) days prior to the end of the Term, Landlord and its designees shall have reasonable access to the Premises for the purpose of exhibiting the same to prospective tenants and to post any "To Let," or "To Lease" signs upon the Premises at a location in the front of the building approved by Tenant, which approval shall not be unreasonably delayed or withheld. (c) Landlord shall have the right to carry material in and on the Premises and to perform work in or on the Premises pursuant to the provisions of this lease, without the same constituting an actual or constructive eviction to Tenant, in whole or in part. Rent shall be abated to the extent that the Premises are rendered unusable for Tenant's business. ASSIGNMENT AND SUBLETTING. 15. Except to a parent, subsidiary or affiliate of Tenant, Tenant shall not either voluntarily, or by operation of law, assign, transfer, mortgage, pledge, hypothecate or encumber this Lease or any interest therein, and shall not sublet the Premises or any part thereof, or any right or privilege appurtenant thereto, or allow any other person (the employees, agents, servants and invitees of Tenant excepted) to occupy or use their Premises, or any portion thereof, without first obtaining the written consent of Landlord, which consent shall not be unreasonably withheld or delayed. When Landlord's consent is not required, Tenant shall remain primarily obligated under the Lease, or provide any necessary guarantees requested by Landlord or its mortgagee. When Tenant requests Landlord's consent to such assignment or subletting, it shall notify Landlord in writing of the name and address of the proposed assignee or subtenant and the nature and character of the business of the proposed assignee or subtenant and shall provide financial statements for the proposed assignee or subtenant. If Landlord approves an assignment or subletting as herein provided, Tenant shall pay to Landlord, as Additional Rent, fifty percent (50%) of the difference, after deduction for the leasing expenses incurred by Tenant including without limitation costs of fit-up, construction, brokerage and legal expenses advertising, if any, between the Rent plus Additional Rent allocable to that part of the Premises affected by such assignment or sublease pursuant to the provisions of this Lease, and the Rent and Additional Rent payable by the assignee or sublessee to Tenant. A consent to one assignment, subletting, occupation or use shall not be deemed to be a consent to any other or subsequent assignment, subletting, occupation or use and consent to any assignment or subletting shall in no way relieve Tenant of any liability under this Lease. Except as provided herein, any assignment or subletting without Landlord's consent shall be void, and shall, at the option of the Landlord, constitute a default -14- 16 Exhibit 10.8 under this Lease. In the event that Landlord shall consent to a sublease or assignment hereunder, Tenant shall pay any brokerage fees related to the subletting or assignment of the Premises. RULES AND REGULATIONS, COMPLIANCE WITH LAWS. 16. (a) Tenant agrees, at all times during the Term hereof, and at its sole cost and expense: (i) not to continue after thirty (30) days notice from Landlord, any action which would violate Landlord's union contracts, if any, affecting the Building or the Premises, or which would create any work stoppage, picketing, labor disruption or dispute, or which would damage, delay or interfere with any work performed or to be performed by Landlord or by any other persons in or about the Building, or which hinder the activities or operations of the Landlord in bringing about the cessation of any work stoppage, picketing or other labor disruption or dispute affecting the Building or any work being performed or to be performed in or about the Building; (ii) to pay promptly and when due, all taxes, licenses, fees, assessments or other charges levied or imposed upon the business of Tenant or upon any fixtures, furnishings or equipment in, on or at the Premises; (iii) not to commit any waste or nuisance, nor use the plumbing facilities for any purpose injurious to same or dispose of any garbage or any other foreign substance therein, nor place a load on any floor in the Premises exceeding the floor load per square foot which such floor was designed to carry, nor install, operate and/or maintain in the Premises any heavy equipment except in a location approved by Landlord, nor install, operate and/or maintain in the Premises any electrical equipment which will overload the electrical system therein, or any part thereof, beyond its capacity for proper and safe operation as determined by Landlord or which does not have Underwriter's approval. (iv) to keep the Premises in a neat, clean, orderly and sanitary condition, (v) to comply with all requirements of all suppliers of public utility services to the Building and not to suffer or permit any act or omission the consequence of which could be to cause the interruption, curtailment, limitation or cessation of any utility service to the Building; (vi) to retain trash, rubbish and garbage created by the Tenant, its representatives, guests, licensees,or invitees within the demised Premises until removed from the site at Tenant's expense. (b) Tenant further agrees, at its sole cost and expense, to promptly comply, or cause compliance, with all laws, ordinances, orders, rules, regulations and requirements collectively "Laws")of all federal, state, county and municipal governments, and appropriate departments, commissions, boards and offices thereof, foreseen or unforseen, ordinary as well as extraordinary, and whether or not the same shall presently be within the contemplation of the parties hereto or shall involve any change of governmental policy in so far as said laws relate and are triggered by Tenant's particular use and do not otherwise apply to buildings used for office, warehouse and research. Landlord shall cure any violations arising from Landlord's original failure to comply with laws, ordinances, orders, rules, regulations and requirements presently applicable to the construction of the Building and shall comply with all Laws applicable to office, warehouse, research (as in existence at Commencement Date and in general and not due to Tenant's particular use. (c) No abatement, diminution or reduction of the -15- 17 Exhibit 10.8 Rental or other charges required to be paid by Tenant pursuant to the terms of this lease, shall be claimed by or allowed to, the Tenant for any inconvenience, interruption, cessation or loss of business or otherwise caused directly or indirectly by any present or future laws, rules, requirements, orders, directions, ordinances or regulations of the federal, state, county or municipal government, or of any other governmental or lawful authority whatsoever, caused by legally required changes in the construction, equipment, operation or use of the Premises. (d) Tenant, following notice to Landlord, shall have the right to contest by appropriate legal proceedings, at its sole cost and expense, the validity of any law, ordinance, order, rule regulation or requirement of the nature herein referred to, provided, however, that: (i) any noncompliance shall not constitute a crime on the part of the Landlord or otherwise adversely affect, jeopardize or threaten the interest of Landlord; (ii) Tenant shall diligently prosecute any such contest to a final determination by a court, department or governmental authority having final jurisdiction and to keep Landlord advised in writing as to all changes in status and determinations in connection with any such proceedings; and (iii) Tenant shall indemnify and save harmless Landlord against any and all losses, costs, expenses, claims, penalties, actions, demands, liabilities, judgments or other damages which Landlord may sustain by reason of such contest or as a result of Tenant's failure or delay in compliance. Landlord shall have the right, but not the obligation to contest by appropriate legal proceedings, at Landlord's expense, any such law ordinance, rule, regulation or requirement. UTILITIES. 17. Tenant agrees to pay as and when the same become due and payable, all water rents, rates and charges, all sewer rents and all similar charges assessed or charged to the Premises during the Term, if any, all charges for electricity, gas, heat, steam, hot water, and other utilities supplied to the Premises during the Term, together with cost of repair, maintenance, replacement and reading of all meters measuring Tenant's use or consumption thereof, whether supplied by Landlord or by a public or private utility company. Tenant's electric charges will be paid directly to the utility company by Tenant, however, in the event that Landlord shall supply any or all the aforesaid services, the charges therefor shall be deemed Additional Rental and be collectible as such on the first day of the following month. In no event shall Landlord be responsible or liable for the failure to supply Tenant or for the failure of the Tenant to receive, any utility service if such failure is due to reasons beyond Landlord's control, nor shall Tenant be entitled to any cessation, abatement, reduction or other offset of Rental in the event of any failure to receive any utility service. SIGNS 18. Tenant may provide, install or maintain any exterior signs on the roof or in the window; or provide, install or maintain any exterior signs on the facade or walls of the Building or on any grounds adjacent thereto, provided all such signs must at all times conform to all applicable rules, regulations, codes and ordinances of any governmental agencies having jurisdiction thereover. All such signs shall be provided, installed, maintained and removed at the termination of the lease, at Tenant's sole cost and expense. Tenant further agrees that it will not place any advertisements or other type of structure or obstruction on the -16- 18 Exhibit 10.8 roof facade or walls of the Building and that it shall not operate any loudspeaker or other device which can be heard outside of the Premises. In the event that Landlord or its agents deem it necessary to remove any such signs in order to paint or make any repairs, alterations or improvements in or upon the Building or any part thereof, they may be so removed, but shall be replaced at Landlord's expense when the said repairs, alterations or improvements shall have been completed. Nothing contained in this Paragraph shall create any obligation on the part of the Landlord to make any repairs, alterations or improvements. TAXES. 19. (a) Tenant covenants and agrees that it shall pay to Landlord, as Additional Rental, its proportionate share of all real estate taxes, assessments, added assessments and other governmental charges or substitutes therefor, foreseen or unforeseen, levied, imposed, assessed or fixed on or against the Building and land constituting the entire tax lot on which the Building is constructed or arising from the use, occupancy or possession thereof, during the Term hereof (hereinafter collectively referred to as the "Taxes"). The proportionate share of Taxes to be paid by Tenant is set forth in Paragraph 20 of this lease. (b) Landlord shall have the right to contest in good faith any such tax, assessment or added assessment and all costs and expenses, including, but not limited to, all legal fees, shall be deemed to constitute additional charges for which Tenant shall pay its proportionate share, as set forth in Paragraph 20 hereof. Tenant shall pay its share of all such costs and expenses, as Additional Rental, on the first day of the month following demand therefor. Provided that the Tenant shall have paid its proportionate share of all costs and expenses in accordance with the provisions of this Paragraph 19(b), Tenant shall be entitled to the same proportionate share of the net proceeds of any refund received by the Landlord as a result of such contest. Landlord agrees to notify Tenant of the filing of any tax appeal or contest, not later than 15 days prior to the filing deadline for which an such appeal is to be taken. (c) In the event that Landlord shall fail to so notify Tenant, then and in such event, Tenant shall have the right to contest in good faith any such tax, assessment or added assessment, at its own cost and expense, provided, however, that notwithstanding such contest, Tenant at all times: shall when due, pay its proportionate share thereof; shall comply with all applicable laws, rules and regulations regarding the payment of taxes; shall not take any action which would adversely affect, threaten or jeopardize the interest of the Landlord in the Building or land; shall promptly pay, indemnify and save Landlord harmless from, all penalties and interest which may be charged or imposed as a result of or during the pendency of, any such contest. In the event of any such contest by the Tenant, Landlord agrees to reasonably cooperate and to execute any necessary papers, provided however, that the same shall be without any cost or expense to the Landlord. However, nothing herein shall require the Landlord to withhold the payment of any tax, interest or penalty otherwise due and owing to, or charged by, the taxing authority. (d) It is further agreed that for the first and last Lease Years of the Term hereof, the portion of all Taxes, other than such as result from added assessments, to be paid by the Tenant shall be pro rated, depending on the proportion which each such Lease Year shall bear to the tax year in which it falls. The portion of Taxes resulting from added assessments to be paid by Tenant during the first and last Lease Years of the Term shall be pro rated depending on the proportion which such Lease Year shall bear to the portion of the tax year for which the added assessment is charged. (e) If at any time during the Term hereof, pursuant to the laws of the Municipality, the County of Bergen, the State -17- 19 Exhibit 10.8 of New Jersey or the United States of America, a tax or excise on rents or other tax, however described, is levied or assessed by any Municipality, County, State or Country or any political subdivision thereof, against the Landlord or the Rental reserved hereunder, or any part thereof, as a substitute, in whole or in part, for any revenues derived from any tax assessed or imposed by any such political entity on land and buildings, the Tenant covenants to pay to Landlord, such sum as shall be necessary to pay and discharge such tax or excise on rents or other tax, which sum shall be paid to Landlord in the manner herein set forth for Taxes, provided, however, that the parties shall have the right to contest said levy in the same manner as provided herein for Taxes. (f) Except as otherwise provided herein, Tenant shall not be obligated or required hereunder to pay any franchise, excise, corporate, estate, inheritance, succession, capital levy or transfer tax of Landlord, or any income, profit or revenue tax upon the income or receipts of Landlord. (g) Tenant shall be responsible for and shall pay prior to the time when such payment shall be deemed delinquent, all taxes assessed during the Term against any leasehold interest, or any improvements, alterations, additions, fixtures or personal property of any nature placed in, on or about the Premises by the Tenant, whether such tax shall have been levied or assessed against the Landlord or the Tenant after the Commencement Date or attributable to Tenant's Work prior to the Commencement Date. ADDITIONAL CHARGES. 20. (a) In addition to all other rental charges provided for in this lease, the Tenant agrees to pay as "Additional Rental," its proportionate share of: (i) all insurance premium costs incurred by Landlord, if any, in connection with its obtaining and maintaining of fire, extended coverage and all risk insurance; rental insurance sufficient to include both Base Rent and Additional Rental; sprinkler damage insurance; and public liability insurance, all of which insurance coverages, if maintained, shall be in such amounts as are maintained by Landlord's comparable buildings and with such companies as Landlord may deem reasonable or proper; (ii) all costs and expenses incurred by Landlord in connection with the Landlord's satisfying Tenants obligations for maintenance, repair and replacements in and to the Leased Premises, in accordance with the provisions of this Lease, including, all costs occasioned by Landlord in the event the Tenant elects, pursuant to Sub-Paragraph 10(d), to have Landlord undertake Tenant's responsibilities (iii) in the event of Tenant electing to have Landlord undertake its responsibilities pursuant to Sub-Paragraph 10 (d), management fees for the operation of the Building, at an annual sum equal to three (3%) percent of the total annual Base Rent for the building; and (iv) Landlord represents that the 1993 estimated cumulative Additional Rental, if Landlord undertakes Tenants responsibilities as aforesaid, would be $1.70 per square foot. The items/services included in this estimate are: real estate taxes, landscape maintenance, snow removal, site lighting, irrigation, insurance, fire sprinkler alarm, management fees and miscellaneous exterior repairs and maintenance. If Tenant elects that the Landlord undertakes its responsibilities under Sub-Paragraph 10 (d), Landlord agrees to limit increases in the total yearly Additional Rental to a maximum of five (5%) percent per annum for the above listed items/services provided on a recurring annual basis. Notwithstanding the foregoing, the aforesaid limitation shall not apply to (1) increases in the cost of any of the above listed items/services due to increases in the frequency of the performance of the above listed items/services (e.g., -18- 20 Exhibit 10.8 variation in snow removal costs in any calendar year as a result of excessive snow falls) , and (2) additional items/services not listed above which may be reasonably supplied by Landlord during the Term and (3) any items with costs which are beyond the control of the Landlord (e.g., real estate taxes and utility rates) (b) It is acknowledged that the total annual Additional Rental to be paid by the Tenant, pursuant to the provisions of Paragraph 19 and 20 of this lease, cannot be determined except on an annual basis. It is therefore agreed that, in addition to the payments of Additional Rental as may be provided for elsewhere in this lease, the Tenant shall pay the estimated monthly sum set forth in (10) of the Preamble on account of its Additional Rental obligations pursuant to the provisions of Paragraphs 19 and 20 of this lease. Said estimated payments shall be paid in advance, on the first day of each month, and shall be based on an annual period from January 1 through December 31 during each year of the Term hereof, and shall be adjusted annually within ninety (90) days following the conclusion of each such annual period by written notice delivered by Landlord to Tenant. Said notice shall set forth the total amount of the costs and expenses incurred by the Landlord for such annual period, the sum which represents the proportion to be paid by the Tenant, the sum actually paid by Tenant for such period, and the amount of any required adjustment. Said notice shall also set forth the estimated monthly payment to be paid by Tenant for the following annual period. (c) For the first and last Lease Years of the Term hereof, the portion of Additional Rental to be paid by the Tenant other than for real estate taxes, shall be pro rated depending on the proportion which each such Lease year shall bear to the aforesaid annual period in which it falls. NON-LIABILITY OF LANDLORD 21. (a) Unless caused by Landlords gross neglect or Willful misconduct, or the gross neglect or willful misconduct of Landlord's agents, employees, guests, contractors, licensees, invitees, assignees or successors, Landlord shall not be liable for any damage or injury which may be sustained by Tenant or by any other person, as a consequence of the failure, breakage, leakage or obstruction of the street or sub-surface; or of the water, plumbing, steam, sewer, waste or soil pipes; or of the roof, walls, drains, leaders, gutters, valleys, downspouts, or the like; or of the electrical, gas, power, conveyor, refrigeration, sprinkler, air conditioning or heating systems; or of the elevators or hoisting equipment; or of any other structural failure; or by reason of the elements; or resulting from theft or pilferage; or resulting from fire, explosion or other casualty; or resulting from the carelessness, negligence or improper conduct on the part of the Tenant, any other tenant, or of Landlord, their agents, employees, guests, licensees, invitees, subtenants, assignees or successors; or attributable to any interference with interruption of or failure, beyond the control of Landlord, of any services to be -19- 21 Exhibit 10.8 furnished or supplied by Landlord. All property kept, maintained or stored in, on or at the Premises shall be so kept, maintained Or stored at the sole risk of the Tenant. Notwithstanding anything Contained herein to the contrary, Landlord shall remain liable for all latent defects and injury or damage that arise therefrom. 22. Intentionally Omitted RIGHT TO CURE DEFAULT. 23. In the event Tenant shall fail to comply fully with any of its obligations hereunder, then Landlord shall have the right, at its option to cure such breach, at Tenant's expense, upon twenty (20) days' prior written notice to Tenant, except in cases of emergency (in which event no notice need be given), and if Tenant shall fail to cure said default within such period, provided however, that if said default cannot be cured with said period, then Tenant shall have commenced in good faith to cure such default within said twenty (20) day period and shall continue to curing thereof diligently thereafter. Tenant agrees to reimburse Landlord promptly (as Additional Rental) for all costs and expenses incurred as a result thereof or in connection therewith, together with interest at an annual rate equal to two (2%) percent above the annual interest rate extended by Citicorp to its most favored borrowers as of the date on which the Landlord made such payment and which interest shall commence to run from the date on which Landlord made any such payment. Any action so taken by Landlord pursuant to this lease shall not serve to waive or release Tenant from its performance of any obligation hereunder. REMEDIES UPON DEFAULT. 24. (a) In the event Tenant shall: (i) default in the payment of the Rental reserved herein or in making any other payment herein provided, said default continuing for a period of ten (10) days after notice of said default; or (ii) default in the observance of any of the other material terms, covenants and conditions of this lease, which default continues for thirty (30) days following the delivery of written notice thereof, ; except that if such default is incapable of cure with thirty (30) days, if the Tenant has not commenced a cure of the default and is not proceeding diligently to cure same; or (iii) assign, sublet or permit the Premises to be occupied by someone other than Tenant, except as herein provided; or (iv) make any assignment for the benefit of creditors, file a voluntary petition in bankruptcy, be by any court adjudicated a bankrupt, take the benefit of any insolvency act or be dissolved or liquidated, voluntarily or involuntarily, or if a receiver or trustee of Tenant and/or its property shall be appointed in any proceedings or if any Guarantor hereunder shall cause or suffer any of such events to occur with respect to itself or; (v) suffer or permit any execution, attachment or other similar process to issue against Tenant or a substantial portion of its property or assets, or suffer or permit the Premises to be taken and/or occupied or attempted to be taken and/or occupied by one other than the Tenant; then, upon the happening of any of the events set forth in this Paragraph, Landlord shall have the right to terminate this lease and the Term hereof upon not less than ten (10) days' written notice to Tenant, with the same force and effect as though the date so specified were the date hereinabove first set forth as the date -20- 22 Exhibit 10.8 of the expiration of the Term (but Tenant shall remain liable to Landlord as hereinafter provided), and at the expiration of the period provided in said notice, the Term hereof and all of the Tenant's right, title and interest hereunder shall cease and terminate, and Landlord without further notice, may reenter the Premises, remove the Tenant and its property therefrom, and have possession and enjoyment of the same, and/or may recover possession thereof as prescribed by law relating to summary proceedings or otherwise, without any liability for damages or prosecution therefrom, it being understood that no demand for the Rental, no reentry for condition broken and no notice to quit or other notice prescribed by law shall be necessary to enable Landlord to recover such possession, but that all rights to any such demand, reentry, notice or other prerequisites are hereby expressly waived by Tenant. (b) In the event of any such default, reentry, expiration and/or dispossess: (i)the Rental shall become due and be paid up to the time of such reentry, dispossess and/or expiration, together with such costs and expenses as Landlord may incur in reacquiring possession of the Premises, for reasonable legal expenses, attorneys' and brokerage fees, putting or restoring the Premises in or to good order and altering or preparing the same for re-rental; (ii) Landlord shall make reasonable efforts, to relet the Premises or any part or parts thereof, either in the name of Landlord or otherwise, for a term or terms which may, at Landlord's option be less than or exceed the period which would otherwise have constituted the balance of the Term, for such rental and on such terms as Landlord shall deem reasonable; (iii) Tenant, or the legal representatives of Tenant, shall pay Landlord any deficiency between the Rental hereby covenanted to be paid and the net amount, if any, of the rents collected on account of any reletting of the Premises for each month of the period which would otherwise have constituted the balance of the Term. In computing such sum, there shall be added to the Rental hereby covenanted to be paid, such expenses of Landlord as are referred to in subparagraph (b) (i) of this Paragraph. Any such deficiency shall be paid in monthly installments by Tenant on the first day of each month, in advance, and any suit brought to collect the amount of the deficiency for any month shall not prejudice in any way the rights of Landlord to collect the deficiency for any subsequent month by a similar proceeding or by joining, consolidating or otherwise including in one action, any and all claims for subsequent periods; (v) Landlord is hereby granted a lien, in addition to any statutory lien or right to distrain which may exist, on all personal property of Tenant in or on the Premises, to secure payment of the Rental and performance of the terms, provisions, covenants and conditions of this lease. Landlord shall have the right, as agent of Tenant, to take possession of any furniture, fixtures or other personal property of Tenant found in or about the Premises and sell the same at public or private sale and to apply the proceeds thereof to the payment of any monies becoming due under this lease, Tenant hereby waiving the benefit of all laws exempting property from execution, levy and sale on distress or judgment. Tenant agrees to pay all legal expenses, attorneys' and brokerage fees and all other costs and expenses incurred by Landlord in exercising its rights hereunder or in Enforcing any of the obligations of Tenant under this lease. (c) Landlord may make such alterations, repairs replacements and/or decorations in or on the Premises as it, in its sole judgment, considers advisable or necessary for the purpose of reletting the Premises; and the making of such alterations, repairs, replacements and/or decorations shall not operate or be construed to relieve Tenant from its liability hereunder. Landlord shall in no event be liable in any way whatever for any failure to -21- 23 Exhibit 10.8 relet the Premises, or in the event that the Premises are relet, for the reasonableness of the rental or for the failure to collect any rent under such reletting. (d) In the event of a breach or threatened breach or violation by Tenant of any of the covenants, conditions, terms or provisions of this lease, Landlord shall have the right to obtain an injunction or to invoke any remedy allowed at law or in equity, without limitation and in addition to, all rights and remedies herein provided for. (e) No receipt and acceptance of Rental by Landlord from Tenant after the termination in any manner of this lease, or the performance by Tenant of any obligation hereunder after the period stated in any notice given pursuant to this lease, shall reinstate, continue or extend the lease or the Term thereof, affect any such notice or cure any default theretofore arising hereunder. No receipt of Rental after the commencement of suit, or after final judgment for possession of the Premises, shall reinstate, cure, continue or extend the lease or the Term thereof or affect said suit or said judgment. (f) The rights and remedies of Landlord specified in this lease, as well as the rights and remedies to which the Landlord is entitled by law or in equity, are cumulative and are not intended to be exclusive of or preclude the exercise of any other rights or remedies which may be available to the Landlord in the event of a breach by Tenant of any provision of this lease. (g) In no event shall the Tenant be entitled to receive all or any portion of any net surplus monies obtained or received by Landlord either in connection with any reletting or as a result of the exercise of any other right or remedy to which Landlord may be entitled. WAIVER OF REDEMPTION. 25. Not used in this Lease. MORTGAGE PRIORITY. 26. This lease shall be and hereby is made subject and subordinate at all times to the lien of all ground and underlying leases and to all mortgages and all advances made thereon which may now or hereafter affect the Building, and to all increases renewals, modifications, consolidations, participations, replacements and extensions thereof, irrespective of the time of recording such lien, without the necessity of any further instrument of subordination. In the event, however, that Landlord or any lessor or mortgagee desires confirmation of such subordination, Tenant shall promptly execute and deliver any certificate or instrument that may be reasonably requested. Tenant's failure to deliver within a reasonable time any such certificate or instrument shall be deemed a default hereunder. Tenant shall not have the right to place any lien or encumbrance of any kind against the Premises, or any of its fixtures, furniture, equipment or improvements, other than a chattel mortgage on its movable trade fixtures. Landlord agrees to cause any present mortgagee or holder of any interest in the Leased Premises to deliver a non-disturbance agreement to Tenant, in their customary form prior to the date of Delivery of Possession. Further, Landlord agrees to cause any future ground lessor or mortgagee to deliver a non-disturbance agreement by each ground lessor and/or mortgagee to Tenant in a form substantially similar to Exhibit D attached hereto including the asterisk addition to the foot thereof at or before the closing of the mortgage. -22- 24 Exhibit 10.8 SURRENDER OF PREMISES. 27. On the expiration date or sooner termination of the Term, Tenant shall quit and surrender the Premises to Landlord, in broom-clean good condition and repair, reasonable wear and tear excepted, as well as all keys to the Premises, together with all alterations, additions and improvements which may have been made in, on or to the Premises, except for movable furniture and equipment, or unattached movable trade fixtures put in at the sole expense of Tenant. Tenant will not be required to remove any improvements made to the Premises which have been approved by Landlord, unless Landlord had advised Tenant of its obligation to do so at the time that Landlord granted its consent. In the event Landlord had so advised, then Tenant, prior to the end of the Term, at its sole cost and expense, shall so restore the Premises, remove therefrom all of its property together with such alterations, additions and improvements as may have been requested by Landlord, and fix and repair any and all damage or defacement to the Building and/or lands caused by the installation and/or removal of alterations, additions, improvements, furniture, equipment, trade fixtures or any other property. Any or all of such property, alterations, additions or improvements not so removed, at Landlord's option, shall become the exclusive property of Landlord or be disposed of by Landlord at Tenant's cost and expense, without further notice or demand. Tenant shall have the right to remove its equipment, fixtures, furnishings and improvements affixed to the Building, all laboratory fixtures and all above standard improvements (whether or not permanently affixed) at the end of the Lease Term, but shall be obligated to fix and repair any and all damage or defacement to the Building and/or lands caused by their installation and/or removal and restore the Premises to a condition suitable for painting (not meaning "paint ready" as that term is commonly used) and carpeting (i.e. walls repaired and spackled, floors cleaned and holes repaired). Tenant's obligation under this Paragraph shall survive the expiration or sooner termination of the Term. UNAVOIDABLE DELAYS. 28. (a) If, as a result of strikes, lockouts, labor disputes, inability to obtain labor, materials or reasonable substitutes therefor, acts of God, governmental restrictions, regulations or controls, enemy or hostile governmental action, civil commotion, insurrection, revolution, sabotage, fire or other casualty, acts or failure to act by Tenant or any other tenant or other conditions beyond the control of Landlord, whether prior to or during the Term, Landlord shall fail punctually to perform any lease obligation, then and in any of such events, such obligation shall be punctually performed as soon as practicable after such condition shall abate. In the event that Landlord, as a result of any such condition, shall be unable to exercise any right or option within any time limit provided in this lease, such time limit shall be deemed extended for a period equal to the duration of such condition. The failure of Landlord to perform any lease obligation for the reasons set forth herein shall not affect, curtail, impair or excuse this lease or the obligations of Tenant hereunder. (b) No diminution or abatement of rent, or other compensation, shall be claimed or allowed for inconvenience or discomfort arising from the making or repairs or improvements to the Building or to its appliances, or arising from the construction of or repairs or improvements to, other buildings, structures, lands or appliances, whether or not the same shall be owned by Landlord. In respect to the various "services", if any, to be furnished by the Landlord to the Tenant, it is agreed that there shall be no diminution or abatement of the rent, or any other compensation, for interruption or curtailment of such "service", when such interruption or curtailment shall be due to accident, alterations or repairs necessary to be made or to inability or difficulty in securing supplies or labor for the maintenance of such "service" or to some other cause, not gross negligence on the part of the Landlord. No such interruption or curtailment of any such "service" nor any non-performance by Landlord pursuant to subparagraph (a) of this Paragraph, shall be deemed a constructive eviction, nor shall there be any abatement or diminution of rent -23- 25 Exhibit 10.8 because of making of repairs, improvements or decorations to the Premises after the date above fixed for the commencement of the Term. LANDLORD CONSENT. 29. With respect to any provision hereof which provides for the consent or approval of Landlord, said consent or approval shall be in writing and shall not be unreasonably withheld or delayed. Tenant in no event, shall be entitled to make any claim. All expenses reasonably incurred by Landlord in reviewing and acting upon any request for consent hereunder, including but not limited to, reasonable attorneys' and architects' fees, shall be reimbursed by Tenant to Landlord, shall be deemed to constitute Additional Rental and shall be paid over to Landlord on the first day of the month following demand therefor. ESCROW FOR FIT-UP. 30. (a) Tenant, shall deposit with First Fidelity the sum set forth in (8) of the Preamble, either in the form of a Letter of Credit, cash, escrow account or other form of security in a manner reasonably acceptable to First Fidelity at the closing of the Mortgage (or such later date as First Fidelity may agree to) in trust for Tenant to be held by First Fidelity for the following limited purposes: (1) to reimburse First Fidelity for any sums it has paid over to the Landlord on account of "Landlords Allowance" which have been paid over to Tenant in the event that (a) the Tenant fails to complete the Tenant's Work in accordance with the terms of this Lease or (b) the Tenant defaults during the Lease Term; (2) as security for the Tenant's compliance with Paragraph 47 of this Lease but only to the extent of any sum paid over to the Landlord by First Fidelity on account of "Landlord's Allowance" which have been paid over to Tenant. (b) In the event that Tenant is not in material default of the terms, provisions, covenants and conditions of this lease, then Tenant shall have the right to reduce the amount of the escrow deposit by ten (10%) percent of the original escrow amount per year and any remaining escrow shall be returned to the Tenant on the expiration of the Term hereof. (c) Tenant shall be entitled to any interest on the aforesaid escrow deposit held by First Fidelity in a segregated account. Tenant further covenants that it will not assign or encumber or attempt to assign or encumber the escrow deposited herein except as permitted under the provisions of Paragraph 15 hereof, and that neither Landlord nor its successors or assigns shall be bound by any such assignment, encumbrance, attempted assignment or attempted encumbrance. (d) It is expressly understood and agreed that the exercise of any remedy by Landlord for any default on the part of Tenant shall no be deemed such a termination of this lease as to entitle Tenant to the recovery of said escrow and said escrow shall be retained and remain in the possession of First Fidelity as hereinbefore stated. CERTIFICATION. 31. Tenant and Landlord each agree, without charge and at any time, within ten (10) days after written request of the other, to certify by written instrument duly executed, acknowledged and delivered to the other or any other person, firm or corporation specified in such request: (a) as to whether this lease has been modified or amended, and if so the substance and manner of such modification or amendment; -24- 26 Exhibit 10.8 (b) as to the validity and force and effect of this lease; (c) as to the existence of any default thereunder by Landlord and Tenant; (d) as to the existence of any offsets, counter claims or defenses thereto on the part of Tenant; (e) as to the commencement and expiration dates of the Term; (f) as to the dates to which Rental payments have been made; (g) as to any other matters as may reasonably be so requested. Any such certificate may be relied upon by Landlord and any other person, firm or corporation to whom the same may be exhibited or delivered, and the Tenant shall be bound by the contents of such certificate. The Tenant hereby constitutes and irrevocably appoints the other as its attorney-in-fact to execute any such instrument or other writing for and on behalf of the Tenant if Tenant shall fail or refuse to execute the instrument within the aforesaid ten (10) day period. Tenant further agrees to furnish to Landlord at any time, but not more frequently than once per year, within ten (10) days after written request of Landlord, a copy of its financial statement for its last full fiscal year, certified by a corporate officer and prepared by independent Certified Public Accountants, including, but not limited to, a profit and loss statement. WAIVER OF TRIAL BY JURY. 32. It is further agreed by and between the parties hereto that they shall and do hereby waive trial by jury in any action, proceeding or counterclaim brought by either of the parties hereto against the other on any matters whatsoever arising out of or in any way connected with this lease, the relationship of Landlord and Tenant, Tenant's use or occupancy of the Premises, and/or any claim or injury or damage. QUIET ENJOYMENT. 33. Landlord covenants and agrees with Tenant that upon Tenant's paying the Rental and observing and performing all of the terms, provisions, covenants and conditions on its part to be observed and performed, Tenant may peaceably and quietly enjoy the Premises during the Term hereof, subject however, to all of the terms, conditions, covenants and provisions of this lease. In the event of any breach by Landlord of this covenant, Tenant may, by not less than thirty (30) days' written notice given to Landlord, cancel this lease, unless within such thirty (30) day period, Landlord shall have commenced appropriate action to cure such breach and shall thereafter proceed diligently to cure such breach. Upon such cancellation, all rights of either party against the other shall cease and the term shall expire with the same force and effect as if the date of such cancellation were the date originally fixed herein for the expiration of the Term. LANDLORD. 34. (a) The term "Landlord" as used in this lease means only the owner, the holder of a lease or the mortgage in possession for the time being of the Premises, so that in the event of any sale of the land and Building of an assignment of this lease or any underlying lease, Landlord herein shall be and hereby is entirely -25- 27 Exhibit 10.8 freed and relieved of all obligations of Landlord hereunder Provided such purchaser, assignee or lessee has assumed and agreed in writing to observe and perform all obligations of Landlord hereunder. (b) Notwithstanding anything herein contained to the contrary, it is specifically understood and agreed that there shall be no personal liability on the part of the Landlord, its successors or assigns, with respect to any of the terms, provisions, covenants and conditions of this lease, and that Tenant shall look solely to the estate, property and equity of Landlord or such successor in interest in the Building and subject to the prior rights of any mortgagee or ground lessee, for the satisfaction of each and every remedy of Tenant in the event of any breach by Landlord or by such successor in interest of any of the terms, provisions, covenants and conditions of this lease to be performed by Landlord, which exculpation of personal liability shall be absolute and without exception. NOTICES. 35. All notices, demands or requests required under the terms of this lease shall be given in writing by either party to the other and shall be complete by personal delivery or by mailing such notices by certified or registered mail, return receipt requested, to the Landlord at the address set forth hereinabove, and to the Tenant at the Premises, or to such other address as either party may designate in writing, which notice of change of address shall be given in the same manner. Copies of any Notice of Default shall be forwarded to Counsel: Smith, Stratton, Wise, Heher & Brennan, 600 College Road East, Princeton, NJ 08540, Attn: Richard J. Pinto, Esq. COVENANTS, EFFECT OF WAIVER. 36. (a) Every term, condition, agreement or provision set forth in this lease shall be deemed to also constitute a covenant. (b) The waiver of any term, provisions, covenant or condition by Landlord shall not be construed as a waiver of a subsequent breach of the same or any other term, provision, covenant or condition, and the consent or approval by Landlord to or of any act by Tenant requiring Landlord's consent or approval shall not be construed to waive or render unnecessary Landlord's consent or approval to or of any subsequent similar act by Tenant. The failure of Landlord to insist in any one or more instances upon the strict performance of any term, condition, provision, covenant or agreement or to exercise any option or any right hereunder, shall not be construed as a waiver or relinquishment of the same for the future. The receipt by Landlord of any Rental payment or the acceptance by Landlord of the performance of anything required to be performed by this lease, with knowledge of a breach of any term, condition, provision or covenant of this lease shall not be deemed a waiver of such breach. No term, condition, provision or covenant of this lease shall be deemed to have been waived unless such waiver is in writing and signed by Landlord. No payment by Tenant or receipt and/or acceptance by Landlord of a lesser sum than the agreed upon Rental shall operate or be deemed or construed to be other than on account of the earliest Rental then unpaid, nor shall any endorsement or statement on any check or any letter or writing accompanying any check nor the acceptance of any check or payment be deemed an accord and satisfaction, and Landlord may accept such check or payment without prejudice to its right to recover the balance of any Rental or to pursue any other remedy to which it may be entitled. HOLDING OVER. 37. Any holding over or continued occupancy by Tenant -26- 28 Exhibit 10.8 after the expiration of the Term of this lease shall not operate to extend or renew this lease or to imply or create a new lease. In such event, Landlord shall have the right to immediately terminate the Tenant's occupancy, or to treat the Tenant's occupancy as a month-to-month tenancy, in which event Tenant shall continue to pay the Rental charges and shall perform all obligations as shall be in effect immediately prior to the termination of the Term hereof. In no event however, shall Tenant be relieved of any liability to Landlord for damages resulting from such holding over. REFERENCE. 38. Wherever herein the singular number is used, the same shall include the plural, and the masculine gender shall include the feminine and neuter genders, if applicable. The paragraph headings and captions used herein are for reference and convenience only. The words "reenter" and "reentry" as used herein are not restricted to their technical legal meaning. ENTIRE AGREEMENT. 39. This lease contains the entire agreement between the parties. No oral statement or prior written matter shall have any force or effect nor shall the waiver of any provision of this agreement be effective unless in writing, signed by the waiving party. Tenant agrees that it is not relying on any representations or agreements other than those contained in this lease. This agreement shall not be modified except by a writing executed by both parties, nor may this lease be cancelled by Tenant except with the written consent of Landlord, unless otherwise specifically provided herein. The covenants, provisions, terms conditions and agreements contained in this lease shall bind the Landlord and Tenant and their respective successors and assigns and shall inure to the benefit of the Landlord, the Tenant, their respective successors, the assigns of Landlord and the assigns of Tenant who shall have obtained an assignment of lease in accordance with the provisions of this lease. ATTORNMENT. 40. At the option of the Landlord, a purchaser of the Building, or the holder of any mortgage or ground lease affecting -27- 29 Exhibit 10.8 the Premises, Tenant agrees that neither the cancellation nor the termination of any ground or underlying lease to which this lease is now or may become subject or subordinate, nor the sale of the Building, nor the foreclosure of any mortgage affecting the Premises, nor the institution of any suit, action, summary or other proceeding by Landlord or any mortgagee shall, by operation of law or otherwise, result in the cancellation or termination of this lease or the obligations of Tenant hereunder, and Tenant covenants and agrees in such event to attorn to Landlord or to the holder of such mortgage or ground or underlying lease or to the purchaser of the Building, whether by foreclosure or otherwise. REAL ESTATE BROKER. 41. Landlord and Tenant each represent to the other that it has dealt with no real estate broker in connection with this lease unless so stated in the Preamble. Each of Tenant and Landlord agree that if any claims should be made for commissions by any other broker by reason of any acts of Tenant or Landlord or its respective representatives, Tenant or Landlord, as the case may be, will indemnify and save harmless the other from any and all claims, demands! losses, liabilities, judgments, costs, expenses, attorneys' fees or other damages resulting from, arising out of, or in connection with that parties acts. Landlord agrees to pay brokerage commission due in connection with this lease, if any, to the broker named in the Preamble in accordance with the terms and conditions of a separate agreement entered into or to be entered into between the Landlord and said broker. VALIDITY OF LEASE. 42. The terms, conditions, covenants and provisions of this lease shall be deemed to be severable. If any clause or provision herein contained shall be adjudged to be invalid or unenforceable by a court of competent jurisdiction or by operation of any applicable law, the same shall be deemed to be severable and shall not affect the validity of any other clause or provision herein, but such other clauses or provisions shall remain in full force and effect, unless such provisions shall relate to any payment of Rental hereunder. In such event, Landlord, on not less than thirty (30) days written notice to Tenant, shall have the right to terminate this lease on the date specified in such notice, whereupon all Rental charges shall be apportioned as of the date of termination and with the same force and effect as if the lease terminated on the maturity date set forth herein. COMMON AREAS. 43. Not used in this Lease. REPRESENTATIONS. 44. Tenant represents that it is a corporation in good standing of the State of New Jersey, that there are no judgments or suits pending against it, and that it does not owe any taxes, that and are its President and Secretary respectively, and that they are empowered and authorized to enter into this lease for and on behalf of the corporation. Tenant agrees to deliver to Landlord simultaneously with the execution hereof, a certified copy of a resolution of its Board of Directors authorizing the execution of this lease. ECRA AND ENVIRONMENTAL LAWS. 45. (a) the parties hereto recognize that the occupancy and use of the Premises by the Tenant may be governed by the provisions of the New Jersey Environmental Cleanup Responsibility Act, N.J.S.A 13:1K-6 et seq. and the regulations promulgated thereunder (ECRA). As such, subject to Landlord's obligations -28- 30 Exhibit 10.8 hereunder, the Tenant hereby covenants that prior to any "closing, terminating or transferring of Tenant's operations" (as said terms are defined by ECRA) at the demised Premises, the Tenant shall, at Tenant's own expense, receive from the Bureau of Industrial Site Evaluation (the "Bureau")of the New Jersey Department of Environmental Protection and Energy (N.J.D.E.P.E) either: (i) a non-applicability letter; (ii) approval of a negative declaration; or (iii) a non-qualified approval of Tenant's cleanup plan. The Tenant shall promptly apply for ECRA approval at least six (6) months prior to the occurrence of any event that would trigger ECRA responsibility on the part of the Tenant as herein provided. Landlord shall cooperate with Tenant in furnishing such information as may be required by NJDEPE or which is otherwise reasonably required by Tenant in connection with said approvals. (b) Tenant shall promptly furnish to Landlord true and complete copies of all documents, submissions and correspondence provided by Tenant to the Bureau and all documents, reports, directives and correspondence provided by the Bureau to Tenant. Tenant shall also promptly furnish to Landlord true and complete copies of all sampling and test results obtained from samples and tests taken at and around the Premises if any. (c) Tenant shall, at Tenant's own expense, comply with ECRA and all orders and directives of the Bureau and shall implement and complete all required cleanups to the satisfaction of the bureau resulting from Tenant's use and occupancy of the Premises during the term of this Lease. (d) Should the submission of a cleanup plan be required pursuant to ECRA by reason of a violation of either ECRA or any other Environmental Law (as hereinafter defined) by the Tenant, its agents, servants, employees, contractors or invitees, Tenant shall satisfy the minimum financial security requirements under ECRA, furnish to NJDEPE security satisfactory to NJDEPE, in the form of a bond or letter of credit issued by a financial surety authorized to do business in the State of New Jersey, guaranteeing the performance and completion of Tenant's obligations pursuant to ECRA. The security furnished by Tenant shall be renewed and kept in force by Tenant, at Tenant's own expense, until such time as Tenant shall have received final approval of the cleanup and a release of the financial sureties from NJDEPE. (e) In the event Tenant is unable to obtain either (a) a non-applicability letter, (b) an approval of a negative declaration or (c) an approval of a cleanup plan, then Tenant shall, at Tenant's own expense, do everything necessary in order to obtain an administrative consent order from the New Jersey Department of Environmental Protection and Energy ("NJDEPE"), obligating Tenant to comply, at Tenant's own expense, with all requirements of ECRA, the Bureau and any other division of NDEPE. (f) If ECRA compliance becomes necessary at the Premises due to any action on the part of Landlord, including, but not limited to, Landlord's execution of a sale agreement for the Premises, any change in ownership of the Premises, initiation of bankruptcy proceedings, Landlord's financial reorganization or sale of the controlling share of the Landlord's assets, the Landlord shall comply with ECRA t Landlord's own expense, provided however, that Tenant shall cooperate with Landlord by preparing and filing all documents and furnishing such information as may be required by NJDEPE or which is otherwise reasonably required by Landlord in connection with such sale, financing or transfer of interest. (g)Landlord represents and warrants to Tenant that, to the best of its knowledge and belief, the Leased Premises are in full compliance with all Environmental Laws and that there -29- 31 Exhibit 10.8 is no hazardous substance or waste at the Leased Premises Landlord has received no notice of any violation of Environmental Laws. (h) The Tenant agrees that it shall not do or omit to do nor suffer the commission or omission of any act, the commission or omission of which is prohibited by or may result in liability under any Environmental Law, including, without limitation, the discharge of petroleum products or other Hazardous Substances or Wastes (as hereinafter defined). If Tenant or its agents, servants, employees, contractors or invitees, violates, during Tenants occupancy, any Environmental Law, Tenant shall, at its sole cost and expense, undertake any and all remedial measures required and otherwise comply with all Environmental Laws. (i) If there is any violation of Environmental Laws which exists on the Possession Date or any violation of Environmental Laws which occurs thereafter by anyone or any entity other than the Tenant, its agents, servants, employees, contractors, or invitees, Landlord, at its sole cost and expense, shall undertake any and all remedial measures required and otherwise comply with all Environmental Laws. (j) The term "Environmental Laws" as used herein means all present and future federal, state or local laws, ordinances, rules, regulations, opinions, orders, directives and policies as the same, from time to time, may be amended, which relate to the environment, health or worker safety, including, but not limited to ECRA;the Resource Conservation Recovery Act, 42 U.S.C. Section 6901 et seq.; the Comprehensive Environmental Response Compensation and Liability Act, 42 U.S.C. Section 9601 et seq; the Clean Water Act, 33 U.S. C. Section 1241 et seq. ; the Spill Act; the New Jersey Water Pollution Control Act, N.J.S.A. 58:10A-1 et seq.; the Water and Community Right to Know Act, N.J.S.A. 34:5A-1 et seq.; The Spill Compensation and Control Act, N.J.S.A. 58:10-23.11 et seq., and the Occupational Safety and Health Act of 1979, 29 U.S.C. Section 651 et seq. The term "Hazardous Substances or Waste s" as used herein means any material, waste or other substance, whether solid, liquid or gaseous, which is defined as a hazardous substance, hazardous waste, toxic substance or toxic waste in any Environmental Laws. (k) The Tenant shall indemnify, defend and hold the Landlord harmless from any and all losses of whatever nature including but not limited to, lost rentals, claims, fines, filing fees, costs, and reasonable counsel, engineering and other professional or expert fees, that Landlord may sustain as a result of the Tenant's failure to comply in a timely fashion with the provisions of this Paragraph 45. (1) The Landlord shall indemnify, defend and hold the Tenant harmless from any and all losses of whatever nature including, but not limited to, lost rentals, claims, costs, and reasonable counsel, engineering and other professional or expert fees, that Tenant may sustain as a result of the Landlord's failure to comply in a timely fashion with the provisions of this Paragraph 45. (m) This paragraph shall survive the expiration or earlier termination of this lease. OPTION TO RENEW. 46. The Tenant shall have two (2) five (5) year options to renew this Lease, by giving the Landlord written notice of its intent to exercise its option to renew this Lease for the five (5) year term no later than six (6) months prior to the expiration of the previous term. However, this option shall be available to Tenant if and only if the Tenant is not in breach of any material condition or term of this Lease after notice and expiration of the -30- 32 Exhibit 10.8 applicable period to cure such breach. The terms and conditions of the Lease shall remain the same except for the payment of Base Rent which shall change according to the following formula for the renewal period: (a) Ninety (90) days prior to the expiration of the original term, Landlord and Tenant shall commence negotiations to determine the fair market value of the leased premises for the renewal term of the lease (the "FMV"). The FMV shall incorporate any rent concessions which may prevail in the market at that time. If the parties have not agreed upon the FMV within thirty (30) days, Landlord and Tenant shall each appoint a real estate appraiser within thirty (30) days of the end of the first 30-day period to determine the FMV. Each appraiser shall be a designated MAI appraiser. If either party fails to timely appoint its appraiser, the appraisal of the more timely appointed appraiser shall determine the FMV. (b) As soon as practical after appointment, but within thirty (30) days, each appraiser shall submit an appraisal of the FMV to Landlord and Tenant. Each shall deliver a copy of the appraisal to the other within three (3) days of receipt, with a copy to the other appraiser. If the appraisals submitted are within ten (10%) percent of each other, the average of the two appraisals shall be the FMV. If the appraisals submitted are not within ten (10%) percent of each other, within ten (10) days after the submission of the original appraisals, both appraisers shall jointly select a third appraiser qualified as stated above, whose appraisal shall be restricted to a determination of the FMV in an amount neither greater than the higher of the two other appraisals, nor less than the lower of the two other appraisals. If the two appraisers do not timely select the third appraiser, Tenant and/or Landlord may seek an order of the court of competent jurisdiction for the appointment of a third appraiser. The third appraiser's appraisal shall be averaged with the results of the other two appraisals and such average shall be the FMV. The FMV so determined shall be converted to an Annual Base Rent by multiplying the FMV by 95%. The new Annual Base Rent shall be paid in twelve (12) installments on the first day of each month commencing on the first day of the first month of the renewal term. If the foregoing appraisal procedure shall not result in a determination of the FMV within 90 days after the end of the first 30-day period referred to above, either party may seek a determination by a court of jurisdiction as to the FMV. (c) Landlord, at its sole cost and expense, will repaint and recarpet the Premises (color to be selected by Tenant and quality to be comparable to the original installation) upon the commencement of the first renewal term. CANCELLATION OPTION. 47. Tenant shall have the option to cancel this Lease at the end of the sixtieth (60th) month by giving written notice to Landlord prior to the fifty fifth (55th) month of the Lease and by payment of a cancellation penalty to the Landlord in the amount of One Million One Hundred Forty One Thousand ($1,141,000) Dollars prior to the sixtieth (60th) month of the Lease. EXPANSION. 48. If during the term of this Lease Tenant requires additional space and notifies Landlord in writing of its requirements, Landlord shall respond to Tenant's request within twenty (20) days with a proposal for leasing such space which includes a build-out allowance and terms and conditions. If Tenant and Landlord enter into an expansion agreement which would provide for additional space to be constructed for Tenant, it shall be conditioned upon Landlord's ability to expand the building. Landlord shall proceed diligently to obtain the necessary approvals for the expansion in accordance with the terms of the aforesaid -31- 33 Exhibit 10.8 expansion agreement. If Landlord is unable to obtain the necessary approvals for the expansion within six (6) months of the expansion agreement, then either party may elect to terminate the expansion agreement. ENVIRONMENTAL SURVEY. 49. Tenant shall arrange for an environmental investigation of the Leased Premises. Upon Tenant's receipt of the results of said investigation, Tenant shall send Landlord a copy of the report. Notwithstanding anything contained herein to the contrary, Tenant, at its option, may terminate this Lease upon written notice to Landlord sent on or before January 27, 1993, in the event that Tenant, in its sole discretion, is not satisfied with the results of the environmental report. Termination shall be deemed effective as of the date of said notice as if said date were the original termination date set forth in this Lease. Landlord shall immediately return any monies paid to, or deposited with Landlord, to Tenant. If Tenant has commenced work at the premises, Tenant shall have the same rights to remove its improvements, fixtures and equipment and the same obligations to restore the premises as it would otherwise have upon the termination or expiration of the Lease. NON-BINDING NATURE OF SUBMITTAL. 50. It is understood by the Tenant that the submission of this Lease to the Tenant for execution in no way binds the Landlord to any of the terms or contents therein unless or until this Lease has been executed by a duly authorized Partner of the Landlord. IN WITNESS WHEREOF, the parties hereto have hereunto set their hands and seals or caused these presents to be signed and sealed by their proper corporate officers the day and year first above written. ATTEST: DATE: RAMSEY ASSOCIATES 1/11/93 By: /s/ Michael E. Laino ---------------------- ------- -------------------------- Michael E. Laino A General Partner ATTEST: DATE: ALTEON, INC. /s/ Elizabeth O'Dell 1/8/93 By: /s/ Kenneth Ludlum ----------------------- ------ ------------------------ V.P. Finance -32- 34 Exhibit 10.8 ALTEON INC. 165 LUDLOW AVE./NORTHVALE, NEW JERSEY 07647 201/784-1010 Fax:201/784-1344 EXHIBIT C November 5, 1992 Mr. Michael Laino RAMSEY ASSOCIATES 500 Route 17 South Hasbrouck Heights, New Jersey 07604 RE: 170 WILLIAMS DRIVE RAMSEY, NEW JERSEY Dear Mike: This letter will serve to confirm the intent of Alteon Inc. to enter into a lease at 170 Williams Drive, under the following terms and conditions. BUILDING: 170 Williams Drive Ramsey, New Jersey OCCUPANCY: November 1, 1993 SPACE REQUIREMENT: 37,000 square feet, subject to the confirmation of measurement by Alteon's architect. Measurement shall be to the outside wall. INITIAL TERM: Ten (10) years.
RENTAL RATE: Months Base Rent ------ --------- 1-18 $24,736.11 per month ($8.02 p.s.f./annum) 19-30 $28,906.25 per month ($9.38 p.s.f./ annum) 31-120 $44,708.33 per month (14.50 p.s.f./annum)
SECURITY DEPOSIT: Alteon will post either a letter of credit, Security deposit, escrow account or other form of security in a form acceptable to the lending institution financing the improvements in this transaction, in the amount of $1,034,000. Alteon shall have the right, at its option, to reduce the amount of the security by $103,400 at the end of each year of the lease term. -33- 35 Exhibit 10.8 ALTEON INC. 165 LUDLOW AVE./NORTHVALE, NEW JERSEY 07647 201/784-1010 Fax:201/784-1344 Mr. Michael Laino November 5, 1992 Page Two OPERATING EXPENSES: Alteon will have the right to operate the building At its own expense, or to have the landlord operate the building. In the event the landlord operates the building, landlord will cap the annual increase on all operating expenses (excluding non-controllable items such as real estate taxes and utilities ) at 5%. If the Landlord operates the building, Alteon will pay a management fee of 3% of the annual net rent to the Landlord. TENANT CONSTRUCTION: The landlord will contribute $978,500 to Alteon as a cash allowance toward the construction of its tenant space. Any unused portion of this allowance can be converted to cash by Alteon. Alteon shall have the right to competitively bid this project to general contractors and subcontractors for completion of the initial improvements and future alterations over the Initial term of the lease, as long as said contractors and subcontractors are acceptable to the landlord, such acceptance not to be unreasonably withheld. Landlord is encouraged to bid the project. In the event an outside contractor is selected, Landlord's supervisory fee shall be limited to actual and reasonable cost for personnel time and materials. STRUCTURAL REPAIRS/ IMPROVEMENTS: Landlord shall be responsible for water tightness and structural repairs to the building not occasioned by the tenant's misuse or failure to properly maintain the premises during the term. SPACE PLANNING/DESIGN: Alteon is to receive from the Landlord $1.50 per rentable square foot for space planning and working drawings for the Initial Tanant Improvements. RENEWAL OPTIONS: a. Alteon will receive two (2) five (5) year renewal options. b. Option Rental Rate after year ten and year 15 shall be at 95% of the then Fair Market Value including rent concessions. -34- 36 Exhibit 10.8 ALTEON INC. 165 LUDLOW AVE./NORTHVALE, NEW JERSEY 07647 201/784-1010 Fax:201/784-1344 Mr. Michael Laino November 5, 1992 Page Three c. Landlord shall provide Alteon an allowance to repaint and carpet the premises upon the expiration of the ten (10) year occupancy. d. Notice for said renewal option is to be provided by Alteon six (6) months prior to the expiration of the existing lease. All other terms and conditions shall remain as negotiated in the primary lease document. SIGNAGE: Alteon shall have all signage rights which are permitted by existing zoning. NON-PERFORMANCE BY LANDLORD: If Alteon is unable to occupy the leased premises on the planned occupancy date due to non-performance by Landlord, lease commencement shall be postponed by one day for each day of delay caused by Landlord's non-performance. Any real estate costs Incurred by Alteon due to landlord's non-performance shall be paid by landlord. SUBLEASE AND ASSIGNMENT: Alteon will have the right to sublease all or a portion of its space with owner's prior written consent which shall not be unreasonably withheld or delayed. Alteon will have the right to sublease to affiliates or subsidiaries without Landlord's consent. The rights provided to Alteon shall be assignable to any assignee or subtenant. Tenant and Landlord shall divide Equally all profits which may arise out of an assignment or sublet after first deducting all expenses incurred by tenant. The Landlord will not have the right of recapture. HOLD OVER RENT: The holdover provision in the lease will state that the hold over rent will be paid at 100% of the then current base rental rate. All other standard provisions shall remain intact. NON-DISTURBANCE AGREEMENT: A non-disturbance agreement will be provided by the mortgage holder(s) who will be re-financing the building. Alteon will execute a tenant estoppel agreement if requested. The mortgage holder(s) will recognize the tenant and will assume the obligations of the landlord. -35- 37 Exhibit 10.8 ALTEON INC. 165 LUDLOW AVE./NORTHVALE, NEW JERSEY 07647 201/784-1010 Fax:201/784-1344 Mr. Michael Laino November 5, 1992 Page Four TENANT ELECTRIC: Electric charges will be paid directly by Alteon to the utility. CANCELLATION OPTION: Alteon shall have the option to cancel this lease at the end of the fifth year by giving six (6) months notice to the landlord and paying a cancellation penalty of $1,141,000. BUILDING FINANCING: Landlord shall have 30 days from the conclusion of a signed letter of intent to secure a commitment for financing, after which time Alteon, at its option, may elect not to proceed with the transaction. BASE BUILDING WORK: Landlord at its own expense, will complete the Following base building work prior to Alteon's Occupancy: a) install one hydraulic passenger / freight Elevator b) install mutually agreeable windows onto the portion of the lower level which is above grade c) screen the items on the roof from view at The front approach to the building, in a manner aesthetically consistent with the Building exterior. d) Prior to the start of tenant construction, landlord warrants water leakage problem in 1st floor has been fixed or that landlord will take steps, to be approved by tenant, to assure building will be free from water infiltration in the future. RESTORATION: Alteon will not be required to restore the premises to building standard construction or to remove any above-standard improvements that were approved by the Landlord and were completed during initial construction or during the lease term. However, Alteon retains right to remove laboratory fixtures and any other above standard improvements, in which case Alteon will repair any damage created by the removal of fixtures and will leave the space in a condition suitable for painting and carpeting. -36- 38 Exhibit 10.8 ALTEON INC. 165 LUDLOW AVE./NORTHVALE, NEW JERSEY 07647 201/784-1010 Fax:201/784-1344 Mr. Michael Laino November 5, 1992 Page Five EXPANSION: If expansion space is required, Alteon shall have the right to request Landlord to seek site plan approval for expansion of the building. Landlord shall have six (6) months to achieve approvals within the parameters previously established between landlord and tenant. USE: Tenant is a pharmaceutical development company, with certain special needs pursuant to the laboratory space it plans to build out: [ ] Seven day a week access [ ] 100% fresh air/ducted exhaust for labs [ ] Acid neutralization tanks at lab drains [ ] Chemical waste pick-up by contractor [ ] Radioisotope usage - licensed by NRC [ ] Radioisotope disposal and pick-up by licensed contractor [ ] A standard pharmaceutical animal testing facility. BROKERAGE: Landlord shall be responsible for any payment due the Edward S. Gordon Company of New Jersey Inc., ("Broker") as the broker in the transaction, subject to a separate agreement between Landlord and Broker. This letter of intent is subject to the execution of a mutually satisfactory lease document, and is subject to the approval of Alteon's Board of Directors. Sincerely, /s/ Kenneth Ludlum Agreed and Accepted: - ------------------ By: Ramsey Associates Kenneth Ludlum /s/ Michael Laino Vice President - Finance ----------------- Michael Laino - General Partner cc: David Sherman Andrew Kaplan -37- 39 Exhibit 10.8 EXHIBIT D Prepared by:___________________________ Name:_______________________________ Date:________________________________ MORTGAGEE: FIRST FIDELITY BANK, NATIONAL ASSOCIATION, NEW JERSEY 570 Broad Street, Newark, New Jersey 07102 Commercial Real Estate Department Attention:____________________________________________________ ______________________________________________________________ MORTGAGOR: Name:_________________________________________________________ LESSEE: Name:_________________________________________________________ Mailing Address:______________________________________________ ______________________________________________________________ ______________________________________________________________ MORTGAGED Street Address:_______________________________________________ PREMISES: Municipality of:______________________________________________ County of ______________________________, State of New Jersey Tax Map Designation: Lot No. ____________ Block No. __________ Deed Reference: Date of Deed _________________________________ Recorded - Deed Book No. _______________ Page No. ____________ DATE OF LEASE: ______________________________________________________________ The Mortgagee and Lessee hereby agree as follows: 1. STATEMENT OF FACTS. 1.1 The Lessee has entered into the Lease covering all or a portion of the Mortgaged Premises. 1.2 As security for a loan made by the Mortgagee to the Mortgagor, the Mortgagor has given to the Mortgagee a mortgage dated __________________________ on the Mortgaged Premises (the "Mortgage"). 1.3 As a condition of making the loan, the Mortgagee has required that the Lease be subordinated to the loan and terms of the Mortgage and in exchange for such, the Lessee has requested and the Mortgagee has agreed not to disturb Lessee's possessory rights in the Mortgaged Premises provided that the Lessee is not in default under the Lease and that the Lessee attorns to the Mortgagee or purchaser at the foreclosure sale. 2. SUBORDINATION OF LEASE. The Lease is and shall be subject and subordinate to the Mortgage and to all renewals, modifications, consolidations, replacements and extensions thereof, to the full extent of the principal amount and other sums secured thereby and interest thereon, as though the Mortgage had been executed, acknowledged, delivered, recorded and properly indexed prior to the execution and delivery of the Lease. 3. ATTORNMENT 3.1 The Lessee agrees that it will attorn to and recognize (i) any purchaser at a foreclosure sale under the Mortgage; (ii) any transferee who acquires possession or title to the Mortgaged Premises by deed in lieu of foreclosure or other means; and (iii) the successors and assignee of such purchase and/or transferees, as its landlord for the unexpired balance (and any extensions, if exercised) of the term of the Lease upon the same terms and conditions set forth in the Lease. Such attornment shall automatically become effective, without the need for execution of any further instrument by any of the parties hereto; provided, however, that Lessee will upon request by the Mortgagee, or any subsequent owner, execute a written agreement whereunder the Lessee will attorn to the Mortgagee or any subsequent owner, affirm Lessee's obligations under the Lease and agree to pay all rentals and charges that are or to become due as they become due to the Mortgagee or such subsequent owner. 3.2 In the event that the Mortgagee shall succeed to the interest of the Mortgagor under the Lease, and/or to title to the Mortgaged Premises, the Mortgagee and the Lessee hereby agree to be bound to one another under all of the terms, covenants and conditions of the Lease; provided, however, that the Mortgagee (or any other party acquiring the Mortgaged Premises upon a foreclosure sale or from the Mortgagee) shall not be (i) liable for any act or omission at any prior landlord (including the Mortgagor); (ii) liable for the return of any security deposit to the extent not paid over to the Mortgagee; (iii) subject to any offsets or defenses which the Lessee might have against any prior Landlord (including the Mortgagee) (iv) bound by any rent or additional rent which the Lessee might have paid for more that the current month to any prior landlord (including the Mortgagor) to the extent not paid over to the Mortgagee; or (v) bound by any amendment or modification of the Lease made without its prior express written consent. 3.3 The Lessee agrees, until any such attornment, not to pay rent or additional rent under the Lease for more than one month in advance without the prior express written consent of the Mortgagee. 3.4 The Lessee shall have no right to appear in any foreclosure action under the Mortgage. 4. ACCEPTANCE OF COLLATERAL ASSIGNMENT OF LEASES. The Lessee acknowledges notice of and consents to that certain Assignment of Leases from the Mortgagor to the Mortgagee, dated ______________, 19______. (the "Assignment"). The Lessee agrees with the Mortgagee and the Mortgagor that, in the event the Mortgagee becomes a mortgagee-in-possession of the Mortgaged Premises, or otherwise takes title to the Mortgaged Premises, upon demand or notice as provided in the Assignment, the Lessee shall make payment of all monies due under the Lease directly to the Mortgagee. Any such payment shall be made notwithstanding any -38- 40 Exhibit 10.8 5. NONDISTURBANCE. 5.1 Provided the Lessee complies with the Agreement and is not in default under the Lease in or otherwise commence foreclosure proceedings, the Mortgagee will not disturb Lessee's possession under the Lease and the Lease will not be affected or cut off by such proceedings* 5.2 The Lessee agrees that this Agreement satisfies any condition or requirement in the Lease relating to the granting of a nondisturbance agreement. 6. RIGHT TO CURE DEFAULTS. 6.1 The Lessee shall promptly notify the Mortgagee by registered or certified mail, return requested, of the occurrence of any default or 6.2 If the Mortgagor shall have failed to cure the event of default within the time provided in the lease, then the Mortgagee shall have an additional thirty (30) days within which to cure the event of default or if it cannot be cured with the time such additional time as may be necessary to effect the cure if within the thirty (30) days the Mortgagee has commenced and it is diligently pursuing the remedies necessary to cure the event of default (including, without limitation, the commencement of foreclosure proceedings, if necessary to affect the cure), in which event the Lease shall not be terminated. 7. ESTOPPEL CERTIFICATES AND NOTICES. 7.1 The Lessee shall deliver to the Mortgagee within ten (10) days of its request, from time to time, certificates as to the continuance of the Lease in effect, payment of rents thereunder and related matters. 7.2 The Lessee shall from the date hereof send to the Mortgagee a copy of any notice or statement required to be sent under the Lease to the Mortgagor, at the same time such notice is sent to the Mortgagor. 8. MISCELLANEOUS. 8.1 Primary Liability. The Lessee represents and warrants that it is now the sole owner of the leasehold estate created by the Lease and that it shall not hereafter assign the Lease, except as permitted by the terms thereof, and that notwithstanding any such assignment or any sublease of the Mortgaged Promise, the Lessee shall remain primarily liable for the observance and performance of all of its obligations and agreement under the lease. 8.2 Modifications. Neither the Lease nor this Agreement may be amended without the prior express written consent of the Mortgagee. 8.3 Binding Affect. This Agreement shall inure to the benefit of the parties hereto, their successors and assigns; provided, however, that (i) in the event of the assignment or transfer of the interest of the Mortgagee, all obligations and liabilities of the Mortgagee under this Agreement shall terminate, and thereupon all such obligations and liabilities shall be the responsibility of the party to whom Mortgagee's interest is assigned or transferred; and (ii) the interest of Lessee under this Agreement may not be assigned or transferred. Nothing contained in this Agreement shall in any way impair or affect the lien created by the Mortgage, except as specifically set forth herein. 8.4 Counterparts. This Agreement may be signed in any number of counterparts with the same affect as if the signature thereto and hereto were on the same instrument. 8.5 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New Jersey. IN WITNESS WHEREOF, this Assignment has been duly executed and delivered by the parties on the day and year first above written: WITNESS: LESSEE: - ----------------------------- ------------------------------------------ Name: (Individual) WITNESS: - ----------------------------- ------------------------------------------ Name (Individual) ------------------------------------------ (Corporation or Partnership) ATTEST: By: - ----------------------------- --------------------------------------- Name: Title: ATTEST: By: - ----------------------------- --------------------------------------- Name: Title: (CORPORATE SEAL) MORTGAGEE: FIRST FIDELITY BANK, NATIONAL ASSOCIATION NEW JERSEY ATTEST: By: --------------------------------------- Name: - ----------------------------- Title: (CORPORATE SEAL)
Mortgagee agrees to immediately recognize and honor all of lessees rights under the Lease and satisfy Landlord's obligations under the Lease, including use of insurance proceeds, condemnation proceeds, and delivery of Tenant's Construction Improvement Allowance. -39-
EX-10.9 6 w46067ex10-9.txt LICENSE AGREEMENT DATED AS OF DECEMBER 30, 1994 1 Exhibit 10.9 [Note: Certain portions of this document have been marked "[c.i.]" to indicate that confidentiality has been requested for this confidential information.] [The confidential portions have been omitted and filed separately with the Securities and Exchange Commission.] LICENSE AGREEMENT BETWEEN CORANGE INTERNATIONAL LIMITED AND ALTEON INC. DATED AS OF DECEMBER 30, 1994 2 Exhibit 10.9 TABLE OF CONTENTS
Page ---- ARTICLE 1 - DEFINITIONS.................................................... 1 1.1 "Affiliate"................................................. 1 1.2 "AGE(s)".................................................... 1 1.3 "Combination Product"....................................... 2 1.4 "Commercial Product"........................................ 2 1.5 "Commercial Sale"........................................... 2 1.6 "Commodity Product"......................................... 2 1.7 "Effective Date of this Agreement".......................... 2 1.8 "Far East Countries"........................................ 2 1.9 "FDA"....................................................... 2 1.10 "Field"..................................................... 2 1.11 "510(k)".................................................... 2 1.12 "Licensed Patents".......................................... 2 1.13 "Licensed Technology"....................................... 3 1.14 "NDA"....................................................... 3 1.15 "Net Sales"................................................. 3 1.16 "Party"..................................................... 4 1.17 "Picower"................................................... 4 1.18 "PMA"....................................................... 4 1.19 "Product"................................................... 4 1.20 "Reagents".................................................. 4 1.21 "Research Product".......................................... 4 1.22 "Territory"................................................. 4 1.23 "Valid Claim"............................................... 4 1.24 "Yamanouchi"................................................ 5 ARTICLE 2 - LICENSE GRANT.................................................. 5 2.1 Grant of License............................................ 5 2.2 Reservation of Rights....................................... 5 ARTICLE 3 - MILESTONE, ROYALTY AND OTHER PAYMENTS.......................... 5 3.1 Initial Payment............................................. 5 3.2 Running Royalties........................................... 5 3.3 Obligation to Pay Royalties................................. 6 ARTICLE 4 - PAYMENTS AND REPORTS........................................... 6 4.1 Payment..................................................... 6 4.2 Mode of Payment............................................. 6 4.3 Records Retention........................................... 6 4.4 Audit Request............................................... 7
i 3 Exhibit 10.9 4.5 Cost of Audit............................................... 7 4.6 Taxes....................................................... 7 4.7 No Non-Monetary Consideration for Sales..................... 7 4.8 Affiliate's Right to Pay.................................... 7 4.9 Sublicense of Affiliates.................................... 8 ARTICLE 5 - DEVELOPMENT OBLIGATIONS AND COMMERCIAL COOPERATION............. 8 5.1 Product Development - Research Assays....................... 8 5.2 Product Development and Registration Milestones - Commercial Assays........................................... 9 5.3 Development of Additional Assays............................ 9 5.4 Conduct of Development Programs by CIL...................... 11 5.5 Collaboration in the Development Process.................... 11 5.6 Joint Inventions............................................ 12 5.7 Collaborative Marketing of AGE Mechanism.................... 13 ARTICLE 6 - RIGHT OF FIRST REFUSAL......................................... 13 6.1 Grant of Right.............................................. 13 6.2 Exercise of Right........................................... 14 6.3 Effect of Exercise.......................................... 14 6.4 Effect of Failure to Exercise............................... 14 ARTICLE 7 - PATENT PROSECUTION, ENFORCEMENT AND INFRINGEMENT............... 14 7.1 Patent Prosecution and Maintenance.......................... 14 7.2 Notification of Infringement................................ 14 7.3 Patent Enforcement.......................................... 14 7.4 Third Party Licenses........................................ 15 7.5 Infringement Action by Third Parties........................ 15 ARTICLE 8 - CONFIDENTIALITY................................................ 16 8.1 Confidential Information.................................... 16 8.2 Confidentiality; Exceptions................................. 17 8.3 Third Party Information..................................... 17 ARTICLE 9 - INDEMNIFICATION................................................ 18 9.1 Indemnification by CIL...................................... 18 9.2 Indemnification by ALTEON................................... 18 9.3 Notice...................................................... 18 ARTICLE 10 - TERM; TERMINATION............................................. 18 10.1 Term........................................................ 18 10.2 Effect of Expiration of Term................................ 19 10.3 Breach...................................................... 19
ii 4 Exhibit 10.9 10.4 Termination by CIL.......................................... 19 10.5 Discontinuance of Sales..................................... 19 10.6 Election Not to Develop Product............................. 19 10.7 Right to Sell Stock on Hand................................. 20 10.8 Termination of Sublicenses.................................. 20 10.9 Effect of Termination....................................... 20 10.10 Surviving Rights............................................ 20 10.11 Accrued Rights, Surviving Obligations....................... 20 ARTICLE 11 - MISCELLANEOUS PROVISIONS...................................... 20 11.1 Relationship of Parties..................................... 20 11.2 Interest on Late Payments................................... 21 11.3 Assignment.................................................. 21 11.4 Disclaimer of Warranties.................................... 21 11.5 Representations and Warranties.............................. 21 11.6 Further Actions............................................. 21 11.7 Patent Marking.............................................. 21 11.8 Sharing of Information...................................... 21 11.9 Force Majeure............................................... 22 11.10 No Trademark Rights......................................... 22 11.11 Public Announcements........................................ 22 11.12 Notices..................................................... 22 11.13 Amendment................................................... 23 11.14 Waiver...................................................... 23 11.15 Counterparts................................................ 23 11.16 Descriptive Headings........................................ 23 11.17 Governing Law............................................... 23 11.18 Alternative Dispute Resolution.............................. 23 11.19 Severability................................................ 24 11.20 Compliance with Law......................................... 24 11.21 Entire Agreement of the Parties............................. 24
iii 5 Exhibit 10.9 EXHIBIT A: U.S. and Foreign Patents and Patent Applications Relating to the Licensed Technology EXHIBIT B: List of Countries Where Patents Will Be Filed and Maintained EXHIBIT C: Rockefeller Agreements EXHIBIT D: Picower Agreements (iv) 6 Exhibit 10.9 LICENSE AGREEMENT LICENSE AGREEMENT, dated as of December 30, 1994 (this "Agreement"), between ALTEON INC., a Delaware corporation, ("ALTEON") and CORANGE INTERNATIONAL LIMITED, a Bermuda corporation ("CIL"). PRELIMINARY STATEMENTS A. ALTEON has acquired, and possesses the right to license, worldwide proprietary rights to a range of health care related technologies discovered at The Rockefeller University, The Picower Institute of Medical Research or at ALTEON, relating to the inhibition or reversal of damage to cells, tissues and organs caused by the formation and cross-linking of advanced glycosylation endproducts, including certain diagnostic technology to measure such endproducts as a marker of disease and dysfunction associated with diabetic complications, aging and related conditions. B. CIL is a common parent company to each of Boehringer Mannheim Corporation and Boehringer Mannheim GmbH. B. CIL and/or its Affiliates have expertise in developing and marketing diagnostic products and wishes to develop and market diagnostic products which utilize such proprietary technology in conjunction with CIL's and/or its Affiliates' proprietary immunodiagnostic kits and instrumentation. C. CIL desires to obtain, and ALTEON is willing to grant, a license to ALTEON's diagnostic technology. NOW, THEREFORE, in consideration of the various promises and undertakings set forth herein, the Parties agree as follows: ARTICLE 1 - DEFINITIONS As used herein, capitalized terms shall have the following meanings: 1.1 "Affiliate", with respect to any Party, shall mean any person or entity controlling, controlled by, or under common control with, such Party. For these purposes, "control" shall refer to (i) the possession, directly or indirectly, of the power to direct the management or policies of a person or entity, whether through the ownership of voting securities, by contract or otherwise or (ii) the ownership, directly or indirectly, of at -1- 7 Exhibit 10.9 least 50% of the voting securities or other ownership interest of a person or entity (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction). 1.2 "AGE(s)" shall mean advanced glycosylation endproducts and any similar biologic or physiologic reference including, but not limited to, Millard reaction products, non-enzymatic glycation products, and like terminology functioning in a substantially similar mechanistic way to such advanced glycosylation endproducts. 1.3 "Combination Product" shall mean a Product that is formulated in combination with one or more active components not in the Field. 1.4 "Commercial Product" shall mean any Product which is not a Research Product. 1.5 "Commercial Sale" shall mean any sale which transfers to a purchaser physical possession and title to any Products in any country in the Territory by CIL or an Affiliate or sublicensee of CIL. 1.6 "Commodity Product" shall mean a diagnostic product sold by a non-Affiliate or sublicensee of CIL which utilizes technology similar to the Licensed Technology, the sale of which does not infringe a Valid Claim, and which is interchangeable in the marketplace with a Commercial Product. 1.7 "Effective Date of this Agreement" shall mean the date first written above. 1.8 "Far East Countries" shall mean Japan, Korea, Taiwan and The People's Republic of China. 1.9 "FDA" shall mean the United States Food and Drug Administration, or any successor thereto. 1.10 "Field" shall mean the use of in-vitro medical diagnostic and analytical chemistry for the detection, monitoring and measurement of the presence of AGEs. 1.11 "510(k)" shall mean an application filed with the FDA prior to the introduction or delivery for introduction of a medical device pursuant to the provisions of Section 510(k) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. Section 321, et seq.) and the regulations promulgated thereunder. -2- 8 Exhibit 10.9 1.12 "Licensed Patents" shall mean any current and future patent or patent application owned by or licensed to ALTEON during the term of this Agreement relating to the Licensed Technology in the Field throughout the Territory, including any substitutions, extensions, renewals, continuations, continuations-in-part, divisions, patents of additions, and/or reexaminations or reissues thereof, and any current and future patent or patent application which is a foreign counterpart in any country in the Territory to any of the foregoing, including any substitutions, extensions, renewals, continuations, continuations-in-part, divisions, patents- of-additions, and/or reexaminations or reissues thereof. ALTEON's current U.S. and foreign patents and patent applications which exist on the Effective Date of this Agreement are set forth on Exhibit A. 1.13 "Licensed Technology" shall mean any and all proprietary information, and all patentable and non-patentable inventions, improvements, discoveries, claims, formulae, processes, methods, trade secrets, technologies, data and know-how owned or exclusively licensed to ALTEON or to which ALTEON has the right to grant licenses or sublicenses before or during the term of this Agreement which identifies or measures the presence or quantity of AGE's as a biological marker for disease and dysfunction associated with diabetic complications, aging and other related conditions. Licensed Technology must not be publicly available, unless it is made publicly available by, on behalf of, or with the consent of CIL. 1.14 "NDA" shall mean a New Drug Application filed with the FDA for marketing approval for a drug pursuant to the Federal Food, Drug and Cosmetic Act (21 U.S.C. Section 321, et seq.) and the regulations promulgated thereunder. 1.15 "Net Sales" shall mean the gross amount invoiced for all Products sold by CIL and its Affiliates and sublicensees in arm's length sales to unrelated third parties, less deductions for: (a) trade, quantity and cash discounts or rebates, credits, allowances or refunds given or made for rejected, outdated or returned Products and the like; (b) any tax or government charge (other than an income tax) levied on the sale, transportation or delivery of a Product and borne by the seller thereof; (c) any charges for freight, postage, shipping, import or export taxes, insurance or charges for returnable containers; and -3- 9 Exhibit 10.9 (d) the actual full cost of financing or servicing of an analyzer or device, in the event that the Product is sold as part of a lease or rental agreement with the customer, whereby an analyzer or other device is placed with the customer and the financing or servicing of such analyzer or device is included in the price of the Product. With respect to the deductions set forth in Sections 1.15(a), (b) or (c), CIL may elect, for any calendar year during the term of this Agreement, to deduct a lump sum of five percent (5%) of Net Sales to cover such items in lieu of taking the deductions set forth in such Sections. In the case of sales of a Combination Product, Net Sales shall be determined by multiplying the Net Sales, as defined above, of such Combination Product by a fraction, the numerator of which shall be the per unit current stand-alone selling price of the component of such Combination Product that would be a Product if sold separately (determined in accordance with generally accepted accounting principles), and the denominator of which shall be the total per unit current stand-alone selling price of all diagnostic technologies and ingredients in such Combination Product, including the price of the component of such Combination Product that would be a Product if sold separately. If there is no established current stand-alone selling price for any component of a Combination Product, the Parties shall negotiate in good faith a formula for determining Net Sales of such Combination Product, taking into account (i) the sales volume of such Combination Product; (ii) the profitability of such Combination Product; and (iii) the proprietary nature and importance of each component of such Combination Product. 1.16 "Party" shall mean ALTEON or CIL and, when used in the plural, shall mean ALTEON and CIL. 1.17 "Picower" shall mean The Picower Institute for Medical Research. 1.18 "PMA" shall mean an application for premarket approval of a medical device filed with the FDA pursuant to Section 515(b) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. Section 321, et seq.) and the regulations promulgated thereunder. 1.19 "Product" shall mean any product in the Field, the manufacture, use or sale of which: (i) uses Licensed Technology; and/or (ii) is covered by one or more Licensed Patents which, but for the license granted hereunder, would infringe a Valid Claim. -4- 10 Exhibit 10.9 The term "Product" includes all Commercial Products, all Research Products, and all Reagents. 1.20 "Reagents" shall mean chemical and biological materials which (i) use Licensed Technology or are covered by one or more Licensed Patents and, but for the license granted hereunder, would infringe a Valid Claim, and (ii) are required for sample preparation or the performance of an AGE specific assay, including but not limited to polyclonal or monoclonal antibodies, clones, antigens, sera, diluents, solution, binding materials and the like. 1.21 "Research Product" shall mean any Product which is sold as an assay for use by research investigators interested in AGE technology for which premarket regulatory approval has not been granted and for which no diagnostic efficacy claims have been made. 1.22 "Territory" shall mean all countries of the world, except the Far East Countries. 1.23 "Valid Claim" shall mean a claim of any issued and unexpired Licensed Patent which has not been held invalid or unenforceable by final decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which is not admitted to be invalid or unenforceable through reissue, disclaimer or otherwise. 1.24 "Yamanouchi" shall mean Yamanouchi Pharmaceutical Co., Ltd. ARTICLE 2 - LICENSE GRANT 2.1 Grant of License. Subject to the terms and conditions of this Agreement, ALTEON grants to CIL an exclusive license throughout the Territory, with the right to grant sublicenses, to make, have made, use, sell and have sold Products in the Field, under the Licensed Technology and Licensed Patents. 2.2 Reservation of Rights. The license granted in Section 2.1 is exclusive to CIL, except that: (a) ALTEON reserves the rights granted by ALTEON to The Rockefeller University ("Rockefeller") or Picower, or reserved by Rockefeller or Picower, pursuant to the agreements attached as Exhibit C and Exhibit D, respectively; and (b) ALTEON reserves the right, on behalf of itself, Rockefeller and Picower, to use the Licensed Technology and the -5- 11 Exhibit 10.9 Licensed Patents without cost to CIL and subject to the confidentiality provisions of this Agreement, solely for internal research and development purposes on a non-commercial basis. ARTICLE 3 - MILESTONE, ROYALTY AND OTHER PAYMENTS 3.1 Initial Payment. As partial consideration to ALTEON for the licenses and other rights granted to CIL under this Agreement, CIL shall pay to ALTEON the sum of [C.I.] upon the execution of this Agreement. Such sum shall be non-refundable. 3.2 Running Royalties. As further consideration of the license and other rights granted to CIL under this Agreement, CIL shall pay to ALTEON a royalty, commencing on the first Commercial Sale of a Research Product or a Commercial Product, as the case may be, by CIL, its Affiliates or its sublicensees, as follows: (a) A royalty in the amount of [C.I.] of Net Sales of Research Products sold in any country in the Territory if the sale would, but for the license granted hereunder, infringe a Valid Claim. (b) A royalty in the amount of [C.I.] of Net Sales of Commercial Products sold in any country in the Territory if the sale would, but for the license granted hereunder, infringe a Valid Claim and where Commodity Products are not sold in such country. (c) A royalty in the amount of [C.I.] of Net Sales of Commercial Products sold in any country in the Territory if the sale would, but for the license granted hereunder, infringe a Valid Claim in the event a Commodity Product is sold in such country that does not infringe a Valid Claim. (d) A royalty in the amount of [C.I.] of Net Sales of all Products will be paid on the sale in any country of the Territory if such sale is not covered by subparagraphs (a), (b) or (c) above. (e) If any country restricts the royalty rate or amount payable on account of sales of Products in such country, the royalties payable under this Agreement with respect to such country shall be automatically adjusted so as not to exceed the maximum amount payable under applicable laws, regulations or administrative rulings of such country. -6- 12 Exhibit 10.9 3.3 Obligation to Pay Royalties. The obligation to pay royalties to ALTEON under this ARTICLE 3 is imposed only once with respect to the same unit of Product regardless of the number of Licensed Patents or Licensed Technology pertaining thereto. There shall be no obligation to pay royalties to ALTEON under this ARTICLE 3 on sales of Products among CIL, its Affiliates and its sublicensees, but in such instances the obligation to pay royalties shall arise upon the sale of Products by CIL, its Affiliates or its sublicensees to unrelated third parties. Payments of running royalties due under this ARTICLE 3 based on Net Sales shall be deemed to accrue when Products are shipped or billed, whichever event shall first occur. ARTICLE 4 - PAYMENTS AND REPORTS 4.1 Payment. All running royalty payments due hereunder shall be paid annually. Royalties accruing on Net Sales in the United States shall be paid by January 31st following the end of each calendar year. All other royalties accruing on Net Sales in other countries in the Territory shall be paid by March 31st following the end of each calendar year. Each such payment shall be accompanied by a statement of the amount of Net Sales during such year, on a quarter-by-quarter, Product-by-Product and country- by-country basis, the amount of royalties due on such Net Sales, and the amount of any credits being applied to such royalties. 4.2 Mode of Payment. CIL shall make all payments required under this Agreement in the United States in United States Dollars. The royalty payments due on the sale of Products outside the United States shall be translated at the rate of exchange at which United States Dollars are listed in The Wall Street Journal for the currency of the country in which the royalty is accrued for the last business day of the calendar quarter in which such sales were made. 4.3 Records Retention. CIL and its Affiliates and sublicensees shall keep complete and accurate records pertaining to the sale of Products in the Territory and covering all transactions from which Net Sales are derived for a period of three calendar years after the year in which such sales occurred, and in sufficient detail to permit ALTEON to confirm the accuracy of royalty calculations hereunder. 4.4 Audit Request. At the request and expense of ALTEON, CIL and its Affiliates and sublicensees shall permit an independent, certified public accountant appointed by ALTEON and acceptable to CIL or its Affiliate or sublicensee, at reasonable -7- 13 Exhibit 10.9 times and upon reasonable notice, to examine those records and all other material documents relating to or relevant to Net Sales in the possession or control of CIL or its Affiliates or sublicensees, for a period of two years after such royalties have accrued, as may be necessary to: (i) determine the correctness of any report or payment made under this Agreement; or (ii) obtain information as to the royalties payable for any calendar year in the case of CIL's failure to report or pay pursuant to this Agreement. Said accountant shall not disclose to ALTEON any information other than information relating to said reports, royalties, and payments. Results of any such examination shall be made available to both Parties. 4.5 Cost of Audit. ALTEON shall bear the full cost of the performance of any such audit, unless such audit discloses a variance resulting in underpayment by CIL of more than 10% of the actual amount due. In such case, CIL shall bear the full reasonable cost of the performance of such audit. 4.6 Taxes. In the event that CIL or its Affiliates are required to withhold any tax to the revenue authorities in any country in the Territory regarding any payment to ALTEON due to the laws of such country, such amount shall be deducted by CIL or its Affiliates, and it shall notify ALTEON and promptly furnish ALTEON with copies of any tax certificate or other documentation evidencing such withholding. All taxes levied on ALTEON's income arising from this Agreement shall be borne by ALTEON. The Parties shall take steps, consistent with current commercial practices, to: (i) avoid or minimize any such withholding; and (b) take advantage of such double taxation avoidance agreements as may be available. 4.7 No Non-Monetary Consideration for Sales. Without the prior written consent of ALTEON, CIL and its Affiliates and sublicensees shall not accept or solicit any non-monetary consideration in the sale of any Product other than as would be reflected in Net Sales. The use by CIL of a commercially reasonable amount of Product for promotional sampling shall not violate this prohibition. 4.8 Affiliate's Right to Pay. ALTEON agrees that any Affiliate of CIL may pay, on behalf of CIL, any obligation of CIL under this Agreement and that such payment shall be received in lieu of payment by CIL in satisfaction of such obligation under this Agreement. Said Affiliate shall make payment to ALTEON in U.S. Dollars pursuant to Section 4.2. Said Affiliate shall use its best efforts to convert the royalties payable on sales in any country to U.S. Dollars; provided, however, that if conversion to and transfer of U.S. Dollars cannot be made in any country for any -8- 14 Exhibit 10.9 reason, payment of royalties may be made in the currency of the country in which such sales are made, deposited in ALTEON's name in a bank designated by ALTEON in any such country. 4.9 Sublicense of Affiliates. Upon written request of CIL, ALTEON will contract directly with any Affiliate of CIL and provide to said Affiliate the right and license granted hereunder in any country in the Territory on substantially the same terms and conditions as those contained herein, provided that CIL shall guarantee to ALTEON performance of such Affiliates' duties and obligations under such contract. ARTICLE 5 - DEVELOPMENT OBLIGATIONS AND COMMERCIAL COOPERATION 5.1 Product Development - Research Assays. (a) During the first calendar quarter of 1995, CIL will initiate the development of a Hemoglobin-AGE assay for research kits using a microtiter plate format. Assuming continued demonstration of the utility of the AGE mechanism and ALTEON's positive clinical experience (e.g., from short-term trials such as a cholesterol and Lipid-AGE placebo control study and an Hb-AGE/A1c comparison study), CIL will also develop two additional research assays for research kits using a microtiter plate format. The order of priority for development of the assays will be: (1) AGE-LDL - first; and (2) AGE-serum protein/peptide - second. The parties contemplate that CIL will initiate development of the AGE-LDL assay in the third calendar quarter of 1995, subsequent to ALTEON's planned commencement of a short term cholesterol and Lipid-AGE placebo control study in humans. Continued development of such AGE-LDL assay will be based upon such clinical data as ALTEON may learn and communicate to CIL. CIL will initiate development of the AGE-serum protein/peptide assay in calendar year 1996 as ALTEON develops or communicates information supporting such development. (b) In addition, in the event that (i) Yamanouchi elects not to accept for development a license of the Licensed Technology and the Licensed Patents in the Field in the Far East Countries and CIL acquires such rights pursuant to the exercise of its Rights under Article 6, and (ii) the Parties agree that a format other than the one developed or being developed pursuant to Section 5.1(a) (e.g. a radioimmune assay) is required in the Far -9- 15 Exhibit 10.9 East Countries taking into consideration input the Parties receive from Yamanouchi or any other ALTEON licensee of AGEs for therapeutic use in Japan, then, if commercially reasonable, CIL shall also develop (or cause a sublicensee to develop) the three (3) research assays listed in Section 5.1(a) for research kits using such different format. 5.2 Product Development and Registration Milestones - Commercial Assays. (a) On execution of this Agreement, CIL will prepare a development plan and schedule for the development of commercial (automated) assays, on a platform to be determined by CIL, taking into account such factors as potential market size, frequency of testing and location of testing (i.e. reference laboratories, etc.) for the assays listed in Section 5.1 (the "Plan"). The Plan will detail assay development milestones and timing which have been mutually agreed upon by the Parties. The Parties agree that the Plan shall be consistent with CIL's internal "New Product Commercialization Process Guideline," as in effect from time to time, a copy of the current version of which has been provided to ALTEON. The development milestones to be agreed upon shall include, without limitation, (i) the timing for the initiation of each assay development, (ii) the timing for the filing of a PMA or 510(k), and (iii) the timing of commercial launch following regulatory approval. Such Plan shall include development milestones that are consistent with the intent of the Parties as set forth in Sections 5.2(b) and 5.2(c). Proposals for such Plan shall be submitted to ALTEON for its review and comment. Such Plan shall be subject to the approval of ALTEON, which will not be unreasonably withheld. (b) It is the intention of the Parties that CIL will commence the development of a commercial automated Hemoglobin-AGE assay prior to or at the time that ALTEON generates data from its Phase III nephropathy clinical trials for pimagedine, or such other clinical trials for pimagedine that ALTEON is conducting, that indicate therapeutic efficiency for pimagedine. In order to allow CIL to budget and plan for such assay development, ALTEON currently anticipates filing for NDA approval of pimagedine between the second quarter of 1997 and the second quarter of 1998. ALTEON will advise CIL from time to time as to delays or other changes in this expectation. (c) Further, it is the intention of the Parties that, at a minimum, CIL shall develop a commercial automated Hemoglobin-AGE assay in a time frame which would permit PMA or 510(k) approval of a commercial assay at the same time as ALTEON obtains NDA -10- 16 Exhibit 10.9 approval for pimagedine, thereby making the Hemoglobin-AGE assay commercially available contemporaneous with the commercial launch of pimagedine as an AGE inhibitor for the treatment/prevention of one or more complications of diabetes. In order to allow CIL to budget and plan for such assay development, ALTEON currently anticipates receiving NDA approval of pimagedine during 1999. ALTEON will advise CIL from time to time as to delays or other changes in this expectation. 5.3 Development of Additional Assays. CIL will have a right of first refusal to develop additional AGE-analytes. These assays will include (but are not limited to) assays to detect: (i) AGE-urine, (ii) AGE-tissue, (iii) AGE-amyloid protein, (iv) AGE-immunoglobulin, (v) pimagedine and similar drug compounds in patient samples, and (vi) triazine and other pimagedine-blocked products in patient samples. With respect to each assay, the following terms will apply: (a) When ALTEON has sufficient information necessary to permit CIL or a third party to determine the business and technical feasibility of developing an assay, ALTEON will notify CIL in writing of the availability of such information. If CIL desires to conduct due diligence with respect to such assay, CIL shall notify ALTEON of its interest in same within thirty (30) days after receipt of notice from ALTEON regarding such assay. CIL will then have six months from the date of ALTEON's initial notice (or until ALTEON receives NDA approval of pimagedine, whichever is longer) to conduct due diligence to determine whether to proceed with the development of such assay. (b) No later than the end of the due diligence period with respect to any assay, CIL may elect to proceed with the development of such assay by sending written notice of such election to ALTEON together with payment to ALTEON, for each additional assay it elects to develop, of the sum of [C.I.] [C.I.]. Such sums shall be non-refundable. Products using such assays shall thereafter be subject to all of the terms of this Agreement applicable to Products, including the royalty rates set forth in Section 3.2. CIL will then prepare a development plan and schedule for the development of such assays, on a platform to be determined by CIL, taking into account such factors as potential market size, frequency of testing and location of testing (i.e. reference laboratories, etc.) for the elected assay(s). The Parties agree that any such plan shall be consistent with CIL's internal "New Product Commercialization Process Guideline," as in effect from time to time. Proposals for such plan shall be submitted to ALTEON for its review and comment. Such -11- 17 Exhibit 10.9 plan shall be subject to the approval of ALTEON, which will not be unreasonably withheld. (c) In the event that CIL declines to conduct such due diligence with respect to an assay pursuant to Section 5.3(a) or does not reply to ALTEON's notice within the thirty (30) day period, and if ALTEON identifies a third party willing to develop such assay, CIL will grant an exclusive sublicense of proprietary rights granted hereunder to enable such third party to develop and commercialize such assay on terms consistent with this Agreement; provided, however, that nothing in this Agreement shall be construed to obligate CIL to assist with or collaborate in the development of such assay. In lieu of the royalty rates set forth in Section 3.2, CIL shall pay fifty percent (50%) of the royalties and other payments received by CIL from such third party sublicensee to ALTEON within thirty (30) days after receipt of such payments. 5.4 Conduct of Development Programs by CIL. CIL shall: (a) Use its reasonable best commercial efforts and proceed diligently to perform the work set out in the plan for each assay being developed; (b) Conduct the development programs in good scientific manner, and in compliance in all material respects with all requirements of applicable laws, rules and regulations, and all other requirements of any applicable good laboratory practices to attempt to achieve its objectives efficiently and expeditiously; (c) During the term of the development programs and promptly following the expiration or termination of each development program, cause appropriate representatives of CIL to meet with representatives of ALTEON, at mutually agreeable times and places or by telephone conference, but at least quarterly, to discuss the progress and developments of any development programs relating to AGE diagnostics. Such meetings shall include, without limitation, the following: (1) Providing ALTEON access to data and progress notes concerning CIL's diagnostic development programs and the opportunity to discuss such data and progress notes with appropriate CIL personnel, in order to assist ALTEON in determining the progress being made and in evaluating the viability, utility and acceptability of future AGE-diagnostics pursuits; (2) Providing ALTEON with reports summarizing all activities under the development programs during the period since -12- 18 Exhibit 10.9 the last meeting, which reports shall be in writing if requested by ALTEON; and (3) At least twice per calendar year, re-evaluating each development plan and, if necessary, proposing modifications to such plan to ALTEON for its review and approval; and (d) Allow representatives of ALTEON, upon reasonable notice and during normal business hours, to (1) visit the facilities where the development programs are being conducted, and (2) consult informally, during such visits and by telephone, with CIL personnel performing work on the development programs. 5.5 Collaboration in the Development Process. (a) ALTEON will provide CIL with access to ALTEON's assay development personnel who will provide a reasonable amount of time, as determined by ALTEON, to assist CIL throughout the development process. (b) ALTEON will use its best efforts to cause Picower to provide CIL with access to appropriate scientists on AGE-related diagnostic and medical knowledge throughout the development process in accordance with the terms of its agreement with Picower, as well as access to individuals at Picower who consult for ALTEON. (c) Subject to the terms of the existing collaborative agreement between ALTEON and Marion Merrell Dow Inc., ALTEON will provide CIL, at the quarterly meetings to be held pursuant to Section 5.4(c), access to data and progress notes concerning ALTEON's AGE therapeutic clinical trials and the opportunity to discuss such data and progress notes with appropriate ALTEON personnel, in order to assist CIL in determining the progress being made and in evaluating the viability, utility and acceptability of future AGE-diagnostics pursuits. (d) ALTEON will provide CIL with a reasonable amount of clinical samples for CIL to use for test development purposes only, as such samples are available. (e) CIL hereby grants ALTEON the right to continue to perform AGE assays on clinical trial samples using its in-house reagents until such time as CIL can supply research grade diagnostic tests to ALTEON which have been appropriately validated pursuant to a criterion mutually agreed upon by the Parties. Thereafter, ALTEON will purchase its requirements of the assay(s) for clinical trial purposes from CIL at CIL's list price for the -13- 19 Exhibit 10.9 assay(s), provided that the use of the CIL assay would not invalidate ALTEON's findings or prior diagnostic results. CIL, however, will provide ALTEON at no cost a reasonable quantity of research assays for ALTEON to use for its preclinical testing and validation purposes. Such test kits will not be included in Net Sales and CIL's provision of test kits to ALTEON at no cost shall not be deemed to violate Section 4.7 of this Agreement. 5.6 Joint Inventions. (a) Any inventions made jointly by CIL and ALTEON that are within the Field shall be jointly owned, but shall be subject to the exclusive license granted hereunder to CIL and subject to all of the terms of CIL's license hereunder. (b) ALTEON will have the right of first refusal to acquire an exclusive license for any inventions made jointly by the Parties relating to therapeutic aspects of the Licensed Technology in accordance with the following terms: (1) CIL shall give written notice to ALTEON of its interest in entering into a licensing arrangement for any such joint invention, together with sufficient information regarding such joint invention which is reasonably necessary for ALTEON to make an informed decision regarding such arrangement, including, without limitation, the commercial terms upon which CIL is interested in offering an exclusive license for such joint invention. ALTEON shall have ninety (90) days after receipt of such notice and information to decide whether or not it wishes to accept such offer. (2) In the event that ALTEON declines to accept such offer with respect to such joint invention or does not reply to CIL's notice within the ninety (90) day period, and if CIL identifies a third party willing to enter into a licensing arrangement for such joint invention on terms no less advantageous to CIL than those offered to ALTEON for such joint invention, ALTEON will, together with CIL, grant an exclusive license of such joint invention to such third party. ALTEON shall collect all royalties from such third party and shall pay fifty percent (50%) of such royalties and other payments received by ALTEON from such third party to CIL within thirty (30) days after receipt of such payments. (3) In no event may CIL conclude any transaction with any third party on terms less advantageous to CIL than those offered to ALTEON without first offering said less advantageous terms to ALTEON in compliance with this Section 5.6(b). -14- 20 Exhibit 10.9 (c) Any other joint inventions outside the Field which do not relate to therapeutic aspects of the Licensed Technology will be jointly owned, and CIL and ALTEON will negotiate in good faith to determine how best to recognize the value of each party's contribution to the joint invention, taking into account (i) the relative efforts by CIL and ALTEON in developing such joint invention; (ii) whether products developed from such joint invention are covered by a valid claim of a patent; (iii) the potential sales volume and profitability of such products; and (iv) the projected expenses of marketing such products. 5.7 Collaborative Marketing of AGE Mechanism. ALTEON and CIL will develop and carry forward an AGE mechanism marketing plan intended to educate medical and clinical laboratory practitioners regarding the utility of the AGE marker and to establish demand for Products and understanding of the clinical and therapeutic utility of the AGE mechanism in general. Following regulatory approval of Products, CIL will actively promote and sell Products in the Territory. On approval of ALTEON's AGE inhibitor agent or other AGE therapeutic products, provided the commercial availability and regulatory claims approved for the use of Products, ALTEON will promote their use in AGE diagnostics and as a diagnostic tool to be used as part of an overall therapy program. ARTICLE 6 - RIGHT OF FIRST REFUSAL 6.1 Grant of Right. Subject to the terms and conditions of this Agreement, ALTEON grants to CIL a right of first refusal to expand the Territory to include the Far East Countries (the "Right") in the event that Yamanouchi elects not to accept for development a license of the Licensed Technology and the Licensed Patents in the Field pursuant to an agreement by and between Alteon and Yamanouchi, such that Yamanouchi retains or receives no financial benefit, either directly or indirectly, from such license (other than the indirect benefit to Yamanouchi sales of therapeutic products by virtue of having commercial assays available). 6.2 Exercise of Right. The Right may be exercised, during the term of this Agreement, for a period of thirty (30) days following ALTEON's notice to CIL of Yamanouchi's election not to accept such license (the "Exercise Period"). CIL may exercise the Right at any time during the Exercise Period by sending to Alteon written notice of the exercise of the Right. CIL will then prepare a development plan and schedule for the development of all assays which CIL is then developing pursuant to Section 5.1 or 5.3 for the Far East Countries, on a platform to be determined by CIL, taking into account such factors as potential market size, frequency of -15- 21 Exhibit 10.9 testing and location of testing (i.e. reference laboratories, etc.) for such assay(s). Proposals for such plan shall be submitted to ALTEON for its review and comment. Such plan shall be subject to the approval of ALTEON, which will not be unreasonably withheld. 6.3 Effect of Exercise. Upon exercise of the Right and agreement on appropriate development milestones for Products in the Far East Countries, the Territory shall be expanded to include the Far East Countries and shall be subject to all of the terms and conditions contained in this Agreement applicable thereto. 6.4 Effect of Failure to Exercise. In the event that CIL declines to exercise its Right or does not reply to ALTEON's notice within the Exercise Period, ALTEON shall be free to negotiate a license for the Products in the Field in the Far East Countries with a third party. ARTICLE 7 - PATENT PROSECUTION, ENFORCEMENT AND INFRINGEMENT 7.1 Patent Prosecution and Maintenance. ALTEON agrees to take all actions reasonably necessary to diligently prosecute and maintain any patents or patent applications relating to the Licensed Technology and ALTEON's AGE technology for therapeutic applications in the countries listed on Exhibit B, which may be modified by mutual agreement of the parties. ALTEON and CIL shall mutually determine the additional countries, if any, where patent applications will be filed and prosecuted, and where the patents will be maintained. The Parties acknowledge and agree that they intend for ALTEON to be required to file and prosecute patent applications and maintain patents in all major commercial markets where viable patent protection is available. If the laws affecting patent protection or maintenance costs change in any such country, the Parties shall reassess the need to continue to file and prosecute patent applications and maintain patents in such country. 7.2 Notification of Infringement. If either Party learns of an infringement or threatened infringement by a third party of any Licensed Patent granted hereunder within the Territory, such Party shall promptly notify the other Party and shall provide such other Party with available evidence of such infringement. 7.3 Patent Enforcement. ALTEON shall have the first right, but not the duty, to institute patent infringement actions against third parties based on any Licensed Patent under this Agreement. If ALTEON does not institute an infringement proceeding against an offending third party within one-hundred twenty (120) days after receipt of notice from CIL, CIL shall have the right, but not the duty, to institute such an action. The costs and -16- 22 Exhibit 10.9 expenses of any such action (including fees of attorneys and other professionals) shall be borne by the Party instituting the action, or, if the Parties elect to cooperate in instituting and maintaining such action, such costs and expenses shall be borne by the Parties in such proportions as they may agree in writing. Each Party shall execute all necessary and proper documents and take such actions as shall be appropriate to allow the other Party to institute and prosecute such infringement actions. Any award paid by third parties as a result of such an infringement action (whether by way of settlement or otherwise) shall be paid to the Party who instituted and maintained such action, or, if both Parties instituted and maintained such action, such award shall be allocated among the Parties in proportion to their respective contributions to the costs and expenses incurred in such action. 7.4 Third Party Licenses. (a) If either Party identifies an infringement or potential infringement of a third party's patent(s) based upon the use of any Licensed Technology to make, use or sell any Product in any country in the Territory, such Party shall promptly notify the other Party and shall provide such other Party with available evidence of such potential infringement. (b) In such event, and during the period prior to the institution of a suit by such third party, ALTEON shall have the first right to obtain, at ALTEON's expense, a license from such third party in such country with respect to such infringing Product. (c) If ALTEON does not obtain a license from such third party in such country with respect to such infringing Product within 120 days after ALTEON receives notice of such potential infringement pursuant to Section 7.4(a), CIL may seek to do so prior to the institution of a suit by such third party. If CIL obtains a license from such third party, CIL shall be entitled to a credit against the payments due hereunder for such Product in such country of an amount equal to the royalty paid to such third party, but in no event shall such credit exceed fifty percent (50%) of such payments due hereunder in any calendar year for such Product in such country which is the subject of such potential infringement. 7.5 Infringement Action by Third Parties. (a) In the event of the institution of any suit by a third party against CIL or its Affiliates, sublicensees, distributors or customers for patent infringement involving the -17- 23 Exhibit 10.9 manufacture, use, distribution, marketing or sale of any Product in the Territory, CIL shall promptly notify ALTEON in writing of such suit. CIL shall have the right to defend such suit at its own expense, and ALTEON hereby agrees to assist and cooperate with CIL, at its own expense, to the extent necessary in the defense of such suit. During the pendency of such action, CIL shall either, at its option: (i) continue to make all payments due under this Agreement to ALTEON, or (ii) make one-half of all payments due under this Agreement resulting from the Product(s) in the country or countries which are the subject of such action into an escrow account at a bank mutually agreed to by the Parties, and continue to make the balance of all payments due under this Agreement to ALTEON. The costs of creating such escrow account shall be deemed to be costs incurred in connection with such action, subject to credit or refund as set forth in Section 7.5(b) or (c), if applicable. (b) If CIL finally prevails because it is held not to be infringing any patents or trademarks belonging to such third party or because such third party's patent is held invalid, CIL shall continue to pay the royalties as set forth in Section 3.2, but shall be entitled to a credit against such payments or a refund from the escrow account (or, if the escrow account is not sufficient to cover the amount due, a credit against such payments), as the case may be, of an amount equal to one-half of the reasonable costs actually incurred in such action, but in no event shall such refund or credit be more than 50% of such payments due hereunder in any calendar year for Products in such country which is the subject of such action. (c) If CIL finally loses, whether by judgment, award, decree or settlement, and is required to pay a royalty to such third party, CIL shall continue to pay the royalties for such Products in the country which is the subject of such action, but shall be entitled to a credit against such payments or a refund from the escrow account (or, if the escrow account is not sufficient to cover the amount due, a credit against such payments), as the case may be, of an amount equal to the royalty paid to such third party, but in no event shall such refund or credit be more than 50% of the payments due hereunder in any calendar year for Products in such country which is the subject of such action. In addition, if CIL incurs litigation expenses or is required to pay damages to such third party, CIL shall be entitled to a refund from the escrow account (or, if the escrow account is not sufficient to cover the amount due, a credit against such payments) of an amount equal to one-half of the reasonable costs actually incurred in such action plus one-half of the damages, but in no event shall the total refund or credit provided herein be -18- 24 Exhibit 10.9 more than 50% of the payments due hereunder in any calendar year for Products in such country which is the subject of such action. ARTICLE 8 - CONFIDENTIALITY 8.1 Confidential Information. It is contemplated that in the course of the performance of this Agreement each Party will, from time to time, disclose proprietary and confidential information to the other. "Information" shall include all disclosures made pursuant to this Agreement in writing and identified as being confidential or, if disclosed orally, is reduced to writing within thirty (30) days of such oral disclosure and identified as being confidential. 8.2 Confidentiality; Exceptions. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing, the Parties agree that, for the term of this Agreement and for five (5) years thereafter, the receiving Party shall keep confidential, and shall take such reasonable measures to maintain such Information as confidential as it takes to protect its own proprietary information, and shall not publish or otherwise disclose and shall not use for any purpose any Information furnished to it by the other Party pursuant to this Agreement, except to the extent that it can be established by the receiving Party by competent proof that such Information: (a) was already known to the receiving Party, other T 21 than under an obligation of confidentiality, at the time of disclosure by the other Party; (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party; (c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; (d) was disclosed to the receiving Party by a third party who had no obligation to the disclosing Party not to disclose such Information to others. (e) was independently developed by the receiving Party by persons who did not have access to the Information. -19- 25 Exhibit 10.9 Each Party may disclose the other's Information to the extent such disclosure is reasonably necessary in filing or prosecuting patent applications, prosecuting or defending litigation, complying with applicable governmental regulations, undertaking basic research with outside collaborators, or conducting preclinical or clinical trials, provided that if a Party is required to make any such disclosure of the other Party's secret or confidential Information it will, except where impracticable for necessary disclosures, for example to physicians conducting studies or to health authorities, give reasonable advance notice to the other Party of such disclosure requirement and, except to the extent inappropriate in the case of patent applications, will use its best efforts to secure confidential treatment of such Information required to be disclosed. 8.3 Third Party Information. The Parties recognize that ALTEON may have development and marketing partners and/or licensees or sublicensees for the research, development and marketing of AGE-related therapeutic products. CIL hereby grants ALTEON the right to share data and information disclosed by CIL relating to AGEs with such third parties, subject to appropriate confidentiality agreements; provided, however, that ALTEON shall not share such data and information with any other licensees of the Licensed Technology in the Field. ARTICLE 9 - INDEMNIFICATION 9.1 Indemnification by CIL. CIL shall defend, indemnify and hold ALTEON, its directors, officers and employees, harmless from and against any and all claims, suits or demands for liability, damages, losses, costs and expenses (including the costs and expenses of attorneys and other professionals) arising out of third party claims or suits resulting from the manufacture, use or sale of Products by CIL, its Affiliates or its sublicensees pursuant to this Agreement, including, without limitation, promotion and advertising of Products and/or interactions and communications with governmental authorities, physicians or other third parties. 9.2 Indemnification by ALTEON. ALTEON shall defend, indemnify and hold CIL, its directors, officers, employees, Affiliates and sublicensees harmless from and against any and all claims, suits, or demands for liability, damages, losses, costs and expenses (including the costs and expenses of attorneys and other professionals) arising out of third party claims or suits resulting from the (i) manufacture, use or sale of ALTEON's AGE inhibitor agent or other AGE therapeutic products and (ii) the promotion of Products outside the scope of regulatory claims approved for -20- 26 Exhibit 10.9 Products, by ALTEON, its Affiliates and its licensees or sublicensees, including, without limitation, promotion and advertising of ALTEON's AGE inhibitor agent or other AGE therapeutic products and/or interactions and communications with governmental authorities, physicians or other third parties. 9.3 Notice. In the event that a Party (an "Indemnitee") seeks indemnification under this ARTICLE 9, the Indemnitee agrees to: (i) promptly inform the other Party (the "Indemnitor") of any claim, suit or demand threatened or filed, (ii) permit the Indemnitor to assume direction and control of the defense or claims resulting therefrom (including the right to settle it at the sole discretion of the Indemnitor), and (iii) cooperate as requested (at the expense of the Indemnitor) in the defense of the claim. ARTICLE 10 - TERM; TERMINATION 10.1 Term. This Agreement shall commence as of the Effective Date of this Agreement and, unless sooner terminated as provided hereunder, shall terminate as follows: (a) As to each Product and as to each country in the Territory: (i) if such Product is covered by Section 3.2(a), (b) or (c), this Agreement shall terminate upon the expiration of the last to expire of the Valid Claims necessary for the use and sale of such Product in such country; and (ii) as to any Product which is covered by Section 3.2(d), this Agreement shall terminate fifteen (15) years from the first Commercial Sale of such Product. (b) This Agreement shall terminate in its entirety upon its termination as to all Products in all countries in the Territory. 10.2 Effect of Expiration of Term. Following expiration of the term of this Agreement, in whole or in part, pursuant to Section 10.1, CIL shall have the royalty-free non-exclusive right and license, within the Field, to continue to make, use and sell the Products as to which this Agreement is terminated, including the right to grant sublicenses therefor, as previously licensed in ARTICLE 2. 10.3 Breach. Failure by CIL to comply with any of the material obligations contained in this Agreement shall entitle ALTEON to give notice to CIL specifying the nature of the default and requiring it to cure such default. If such default is not cured within sixty (60) days after the receipt of such notice (or, if such default cannot be cured within such sixty (60) day period, -21- 27 Exhibit 10.9 if CIL does not commence and diligently continue actions to cure such default), ALTEON shall be entitled, without prejudice to any of its other rights conferred on it by this Agreement, in addition to any other remedies available to it by law or in equity, to terminate this Agreement by giving written notice to take effect immediately. The right of ALTEON to terminate this Agreement, as hereinabove provided, shall not be affected in any way by its waiver or failure to take action with respect to any previous default. 10.4 Termination by CIL. CIL shall have the right to terminate the licenses granted herein, in whole or as to any Product in any country in the Territory, at any time, and from time to time, by giving notice in writing to ALTEON. Such termination shall be effective ninety (90) days from the date such notice is given, and all CIL's rights and duties associated therewith shall cease as of that date, subject to Section 10.7. 10.5 Discontinuance of Sales. ALTEON may terminate the license granted herein, in whole or as to any Product licensed under this Agreement to CIL in any country in the Territory in which CIL voluntarily discontinues Commercial Sales of such Products for any reason other than as set forth in Section 11.9 or that CIL is legally barred from selling such Products and fails to start selling such Products again in such country within one hundred eighty (180) days after delivery of written notice from ALTEON to CIL of such discontinuance. 10.6 Election Not to Develop Product. If CIL elects not to initiate a development program, or has not commenced a program, that is designed to develop and register Product(s) with regulatory agencies in the major markets included in the Territory in accordance with the milestones agreed upon pursuant to Section 5.1, ALTEON, at its sole option, shall have the right to terminate the license granted herein, and this Agreement, by giving notice in writing to CIL of its decision. Such termination shall be effective ninety (90) days from the date such notice is given (unless CIL commences such program within such ninety (90) day period) and, except as otherwise provided in this Agreement, all CIL's rights and duties associated therewith shall cease as of that date. 10.7 Right to Sell Stock on Hand. Upon the termination of any license granted herein, in or whole or as to any Product in any country in the Territory, for any reason other than a failure to cure a material breach of the Agreement by CIL, CIL and its Affiliates and sublicensees shall have the right for six (6) months or such longer period as the Parties may reasonably agree to -22- 28 Exhibit 10.9 dispose of all Product or substantially completed Product then on hand to which such termination applies, and royalties shall be paid to ALTEON with respect to such Product as though this Agreement had not terminated. 10.8 Termination of Sublicenses. Upon any termination of this Agreement, all sublicenses granted by CIL under this Agreement shall terminate simultaneously, subject, nevertheless, to Section 10.7. 10.9 Effect of Termination. Upon the termination of any license granted herein as to any Product in any country in the Territory other than pursuant to Section 10.1, CIL and its sublicensees shall promptly return to ALTEON all relevant records, materials or confidential information concerning the Licensed Patents and Licensed Technology relating to such Product in such country in the possession or control of CIL or any of its sublicensees. 10.10 Surviving Rights. Termination of this Agreement shall not terminate CIL's obligation to pay all royalties which shall have accrued hereunder. The Parties' obligations under ARTICLES 4, 7, 8, 9 and 10 and Sections 11.17 and 11.18 shall survive termination. 10.11 Accrued Rights, Surviving Obligations. Termination, relinquishment or expiration of this Agreement for any reason shall be without prejudice to any rights which shall have accrued to the benefit of either Party prior to such termination, relinquishment or expiration. Such termination, relinquishment or expiration shall not relieve either Party from obligations which are expressly indicated to survive termination or expiration of this Agreement. ARTICLE 11 - MISCELLANEOUS PROVISIONS 11.1 Relationship of Parties. Nothing in this Agreement is intended or shall be deemed to constitute a partnership, agency, employer-employee or joint venture relationship between the Parties. No Party shall incur any debts or make any commitments for the other, except to the extent, if at all, specifically provided herein. 11.2 Interest on Late Payments. Any payments required under this Agreement that are not made when due shall accrue interest at the rate of one percent (1%) per month from the date such payment is due. The Party making such payment shall make the payment together with any accrued interest thereon through the date such payment is made. -23- 29 Exhibit 10.9 11.3 Assignment. Except as otherwise provided herein, neither this Agreement nor any interest hereunder shall be assignable by any Party without the prior written consent of the other; provided, however, that either Party may assign this Agreement to any wholly-owned subsidiary, to any Affiliate (provided that such Affiliate is, directly or indirectly, under 100% common ownership with such Party), or to any successor by merger or sale of substantially all of its assets to which this Agreement relates in a manner such that the assignor shall remain liable and responsible for the performance and observance of all its duties and obligations hereunder. This Agreement shall be binding upon the successors and permitted assigns of the parties and the name of a Party appearing herein shall be deemed to include the names of such Party's successor's and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any assignment not in accordance with Section 11.3 shall be void. 11.4 Disclaimer of Warranties. The parties expressly disclaim any warranties as to validity or enforceability of Licensed Patents, or non-infringement of third party patents. 11.5 Representations and Warranties. Each Party represents and warrants that, to the best of its knowledge: (i) it is free to enter into this Agreement; and (ii) in so doing will not violate any other agreement to which it is a party. 11.6 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement. 11.7 Patent Marking. At ALTEON's request, CIL shall mark in an appropriate manner all containers or packages of Products sold by CIL with the appropriate statutory patent notice for the jurisdiction in which the Product is to be sold to indicate patent coverage has been obtained or patents are pending. 11.8 Sharing of Information. ALTEON and CIL shall keep each other currently informed of relevant progress, plans and information concerning the development, manufacture, use and sale of Products and ALTEON's products to the extent such are reasonably relevant to the work of the other Party. 11.9 Force Majeure. Neither Party shall be liable to the other for loss or damages or shall have any right to terminate this Agreement for any default or delay attributable to any act of God, flood, fire, explosion, strike, lockout, labor dispute, shortage of -24- 30 Exhibit 10.9 raw materials, casualty or accident, war, revolution, civil commotion, act of public enemies, blockage or embargo, injunction, law, order, proclamation, regulation, ordinance, demand or requirement of any government or subdivision, authority or representative of any such government, or any other cause beyond the reasonable control of such Party, if the Party affected shall give prompt notice of any such cause to the other Party. The Party giving such notice shall thereupon be excused from such of its obligations hereunder as it is thereby disabled from performing for so long as it is so disabled and for thirty (30) days thereafter. Notwithstanding the foregoing, nothing in this Section 11.9 shall excuse or suspend the obligation to make any payment due hereunder in the manner and at the time provided. 11.10 No Trademark Rights. Except as otherwise provided herein, no right, express or implied, is granted by this Agreement to use in any manner the name "CIL" or "ALTEON" or any other trade name or trademark of the other party in connection with the performance of this Agreement. 11.11 Public Announcements. Except as required by law, neither Party shall make any public announcement concerning this Agreement or the subject matter hereof without the prior written consent of the other. In the event of a required public announcement, the Party making such announcement shall provide the other with a copy of the proposed text prior to such announcement. 11.12 Notices. All notices and other communications hereunder shall be in writing and shall be deemed given if delivered personally or by facsimile transmission (receipt verified), telexed, mailed by registered or certified mail (return receipt requested), postage prepaid, or sent by express courier service, to the parties at the following addresses (or at such other address for a party as shall be specified by like notice; provided, that notices of a change or address shall be effective only upon receipt thereof): (a) If to ALTEON, addressed to: Alteon Inc. 170 Williams Drive Ramsey, New Jersey 07446-2907 Attention: Chief Executive Officer Telephone No.: (201) 934-5000 Facsimile No.: (201) 934-8880 -25- 31 Exhibit 10.9 (b) If to CIL, addressed to: Corange International Limited c/o Boehringer Mannheim Corporation 9115 Hague Road Indianapolis, Indiana 46250 Attention: Legal Department Telephone No.: (317) 845-2000 Facsimile No.: (317) 576-3082 11.13 Amendment. No amendment, modification or supplement of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party. 11.14 Waiver. No provision of this Agreement shall be waived by any act, omission or knowledge of a Party or its agents or employees except by an instrument in writing expressly waiving such provision and signed by the waiving Party. 11.15 Counterparts. This Agreement may be executed simultaneously in two counterparts, either one of which need not contain the signature of more than one party but both such counterparts taken together shall constitute one and the same agreement. 11.16 Descriptive Headings. The descriptive headings of this Agreement are for convenience only, and shall be of no force or effect in construing or interpreting any of the provisions of this Agreement. 11.17 Governing Law. This Agreement shall be governed by and interpreted in accordance with the laws of the State of New Jersey, applicable to contracts executed and performed wholly within the State of New Jersey. The English original of this Agreement shall prevail over any translation hereof. 11.18 Alternative Dispute Resolution. (a) Except with respect to breaches for which a Party is seeking injunctive relief, all disputes between the Parties relating to this Agreement or the subject matter hereof which cannot be resolved by the Parties, shall, upon written notice by one Party to the other, be submitted for settlement by means of alternative dispute resolution, which can include moderated settlement, minitrial, use of expert advisor mediation or non- binding arbitration, as provided in the New Jersey Alternative Procedure for Dispute Resolution Act, N.J.S.A. 2A:23A-1 et seq. -26- 32 Exhibit 10.9 (the "Act"). All proceedings for the alternative resolution of a dispute (an "ADR Proceeding") shall be designed to conclude within four (4) months of the original notice and shall be held at a mutually agreeable location or in New York City. If the parties cannot agree on the form of ADR Proceeding to be used, then mediation, with an independent mediator acceptable to both Parties, shall be used. All fees and expenses associated with the ADR Proceeding shall be divided equally between the parties; provided that each party shall be responsible for such party's own attorneys' fees and disbursements. The Act shall govern the procedures and methods for any ADR Proceeding demanded or undertaken pursuant to this Agreement. (b) Each person selected for any ADR Proceeding shall be knowledgeable as to the diagnostic industry and will be instructed to consider, in making any determination or recommendation, the customary practices in the diagnostic industry to the extent such practices exist. The Parties will cooperate with each other in causing the ADR Proceeding to be held in as efficient and expeditious a manner as practicable. (c) At the conclusion of the ADR Proceeding, either Party shall have the right to a trial de novo by a court of competent jurisdiction. 11.19 Severability. Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be prohibited by or invalid under applicable law, such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement. 11.20 Compliance with Law. Nothing in this Agreement shall be deemed to permit a Party to export, reexport or otherwise transfer any Licensed Technology or Licensed Patents transferred hereunder or Products manufactured therefrom without compliance with applicable laws. 11.21 Entire Agreement of the Parties. This Agreement constitutes and contains the entire understanding and agreement of the Parties and cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether oral or written, between the Parties respecting the subject matter hereof. -27- 33 Exhibit 10.9 IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed by its duly authorized officer as of the day and year first above written. ALTEON INC. By: /s/ James J. Mauzey ------------------------------------------ Name: James J. Mauzey ---------------------------------------- Title: Chairman, Chief Executive Officer ---------------------------------------- CORANGE INTERNATIONAL LIMITED By: /s/ William Petravic ------------------------------------------ Name: William Petravic ---------------------------------------- Title: Treasurer ---------------------------------------- -28- 34 EXHIBIT A U.S. AND FOREIGN PATENTS AND PATENT APPLICATIONS RELATING TO THE LICENSED TECHNOLOGY 1) Immunochemical Detection of AGE's (Methods and Test Kits for Measuring AGE's by ELISA Assay) U.S. Application #07/956,849 - filed October 1, 1992 P.C.T. Application US92/11158 - filed December 21, 1992 National Phase filings proceeding via a European Patent Application and in Australia, Canada, Japan and Korea Additional filings made in People's Republic of China, Portugal and Taiwan 2) AGE-Lipid Oxidation - Methods of Measuring U.S. Application #08/029,417 - filed March 11, 1993 P.C.T. Application US93/10880 - filed November 12, 1993 3) Improved Method of Detecting Hb-AGE & Diagnostic Methods U.S. Application #08/236,416 - filed April 29, 1994 Decision on PCT filing is pending 4) Monoclonal Antibody specific for AGE's in Biological Samples U.S. Application #08/ , - filed December , 1994 Decision on PCT filing is pending 5) FFI - Diagnostic Divisional - Immunochemical Test for Detecting AGE's Using FFI as an Indicator U.S. Patent #4,761,368 - issued August 2, 1988 European Patent #0322402 - filed February 11, 1989 (Issued in Germany, France and Great Britain) 35 6) Additional Patents and Patent Applications U.S. Patent Application #07/749,438 - filed August 23, 1991 (no foreign counterpart) (Liver-Derived Receptors for AGEs and Uses Thereof) U.S. Patent #5,202,424 - issued April 13, 1993 (no foreign counterpart) (Meangial-Cell Derived Receptors for AGEs and Uses Thereof) U.S. Patent #5,316,754 - issued May 31, 1994 (no foreign counterpart) (Meangial-Cell Derived Receptors for AGEs and Uses Thereof) U.S. Patent #5,108,930 - issued April 28, 1992 (no foreign counterpart) (Aminoguanidine Assay and Applications Thereof) 36 EXHIBIT B LIST OF COUNTRIES WHERE PATENTS WILL BE FILED AND MAINTAINED I. BASE COUNTRIES* United States of America Canada Japan Germany France Great Britain Italy Spain II. ADDITIONAL COUNTRIES SUBJECT TO MUTUAL AGREEMENT OF ALTEON AND CIL* Mexico Australia Others to be determined 37 * applicable to patents/applications covering broad AGE diagnostic technology, novel antibodies and significant commercial improvements thereto. 38 EXHIBIT C ROCKEFELLER AGREEMENTS [Filed as Exhibits 10.4 and 10.5 to the Form 10-K.] 39 EXHIBIT D PICOWER AGREEMENTS [Filed as Exhibit 10.7 to the Form 10-K]
EX-10.10 7 w46067ex10-10.txt RESEARCH COLLABORATION AND LICENSE AGREEMENT 1 Exhibit 10.10 [Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidentiality has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission.] RESEARCH COLLABORATION AND LICENSE AGREEMENT BETWEEN WASHINGTON UNIVERSITY AND ALTEON INC. DATED AS OF JUNE 2, 1995 1 2 Exhibit 10.10 TABLE OF CONTENTS
Page ---- ARTICLE 1 - DEFINITIONS................................................................ 1 1.1 "Affiliate"...................................................... 1 1.2 "ALTEON Research Program"........................................ 2 1.3 "Commercial Sale"................................................ 2 1.4 "Compound"....................................................... 2 1.5 "Dosage Forms"................................................... 2 1.6 "Effective Date of this Agreement"............................... 2 1.7 "Field".......................................................... 2 1.8 "First Commercial Sale".......................................... 2 1.9 "Goldman Patent"................................................. 2 1.10 "Heart Graft Project"............................................ 2 1.11 "Initial Product"................................................ 3 1.12 "Invention"...................................................... 3 1.14 "Investigator(s)"................................................ 3 1.15 "Joint Invention"................................................ 3 1.16 "Licensed Patents"............................................... 3 1.17 "Licensed Technology"............................................ 4 1.18 "Monsanto"....................................................... 4 1.19 "Net Sales"...................................................... 4 1.20 "Other Patents".................................................. 5 1.21 "Party".......................................................... 5 1.22 "Post-Commercialization Income".................................. 5 1.23 "Pre-Commercialization Income"................................... 5 1.24 "Product"........................................................ 5 1.25 "Publication".................................................... 5 1.26 "Sponsored Research Program"..................................... 5 1.27 "Territory"...................................................... 5 1.28 "University Personnel"........................................... 5 1.29 "Valid Claim".................................................... 6 ARTICLE 2 - REPRESENTATIONS AND WARRANTIES............................................. 6 2.1 Representations and Warranties of Both Parties................... 6 2.2 Representations and Warranties of WASHINGTON..................... 6 2.3 Representation and Covenant Regarding U.S. Government Funding.... 7 2.4 Disclaimer of Other Warranties................................... 7 ARTICLE 3 - RESEARCH COLLABORATION AND DEVELOPMENT EFFORTS............................. 7 3.1 Sponsored Research Programs...................................... 7 3.2 ALTEON Research Programs......................................... 8 3.3 Collaboration.................................................... 8 3.4 Exchange of Information.......................................... 8 ARTICLE 4 - LICENSE GRANT.............................................................. 9 4.1 Grant of License................................................. 9 4.2 ALTEON Option for New WASHINGTON Technology...................... 9 4.3 ALTEON Option for Other Patents.................................. 10 4.4 Reservation of Rights............................................ 10 4.5 Retained Rights of U.S. Government............................... 10 4.6 ALTEON's Development Efforts..................................... 10 ARTICLE 5 - MILESTONE, ROYALTY AND OTHER PAYMENTS...................................... 11 5.1 Up-front Payments................................................ 11 5.2 Annual Pre-Commercial Payments................................... 11
i 3 Exhibit 10.10 5.3 Milestone Payments............................................... 11 5.4 Credit Against Royalties......................................... 12 5.5 Pre-Commercialization Income from Sublicensees................... 12 5.6 Running Royalties................................................ 13 5.7 Annual Minimum Royalties......................................... 14 5.8 Obligation to Pay Royalties...................................... 15 ARTICLE 6 - PAYMENTS AND REPORTS....................................................... 15 6.1 Payment.......................................................... 15 6.2 Mode of Payment.................................................. 15 6.3 Late Payments.................................................... 16 6.4 Records Retention................................................ 16 6.5 Audit Request.................................................... 16 6.6 Taxes............................................................ 16 ARTICLE 7 - OWNERSHIP; PATENT PROSECUTION.............................................. 17 7.1 WASHINGTON Ownership............................................. 17 7.2 ALTEON Ownership................................................. 17 7.3 Joint Ownership.................................................. 17 7.4 Patent Prosecution and Maintenance............................... 17 ARTICLE 8 - PATENT ENFORCEMENT; INFRINGEMENT........................................... 19 8.1 Notification of Infringement..................................... 19 8.2 Patent Enforcement............................................... 19 8.3 Infringement Action by Third Parties............................. 20 ARTICLE 9 - PUBLICATION; CONFIDENTIALITY............................................... 21 9.1 Notification..................................................... 21 9.2 Review of Proposed Publications.................................. 21 9.3 Use of Name...................................................... 21 9.4 Confidentiality; Exceptions...................................... 22 ARTICLE 10 - INDEMNIFICATION........................................................... 23 10.1 Indemnification.................................................. 23 10.2 Notice........................................................... 23 10.3 Insurance........................................................ 23 ARTICLE 11 - TERM; TERMINATION......................................................... 25 11.1 Term............................................................. 25 11.2 Breach........................................................... 25 11.3 Termination by ALTEON............................................ 26 11.4 Termination of U.S. Rights....................................... 26 11.5 Right to Sell Stock on Hand...................................... 26 11.6 Termination of Sublicenses....................................... 26 11.7 Effect of Termination............................................ 26 11.8 Surviving Rights................................................. 27 11.9 Accrued Rights, Surviving Obligations............................ 27 ARTICLE 12 - MISCELLANEOUS PROVISIONS.................................................. 27 12.1 Relationship of Parties.......................................... 27 12.2 Assignment....................................................... 27 12.3 Further Actions.................................................. 27 12.4 Force Majeure.................................................... 27 12.5 No Trademark Rights.............................................. 28 12.6 Public Announcements............................................. 28 12.7 Notices.......................................................... 28 12.8 Amendment........................................................ 29 12.9 Waiver........................................................... 29 12.10 Counterparts..................................................... 29
ii 4 Exhibit 10.10 12.11 Descriptive Headings............................................. 29 12.12 Governing Law.................................................... 29 12.13 Arbitration...................................................... 29 12.14 Severability..................................................... 30 12.15 Compliance with Law.............................................. 30 12.16 Entire Agreement of the Parties.................................. 30
iii 5 Exhibit 10.10 EXHIBIT A: U.S. and Foreign Patents and Patent Applications Relating to the Licensed Technology EXHIBIT B: Research Projects Involving Licensed Technology EXHIBIT C: List of Countries Where Patents Will Be Filed and Maintained EXHIBIT D: Form of Confidentiality and Non-Disclosure Agreement (iv) 6 Exhibit 10.10 RESEARCH COLLABORATION AND LICENSE AGREEMENT RESEARCH COLLABORATION AND LICENSE AGREEMENT, dated as of June 2, 1995 (this "Agreement"), between WASHINGTON UNIVERSITY, a Missouri educational and charitable corporation ("WASHINGTON") and ALTEON INC., a Delaware corporation, for and on behalf of itself and its Affiliates ("ALTEON"). PRELIMINARY STATEMENTS A. WASHINGTON has certain rights to the Compound (as defined below) for use in the Field (as defined below) pursuant to the Licensed Patents and Licensed Technology (as such terms are defined below). WASHINGTON also has certain rights to the Compound pursuant to the Other Patents (as defined below). B. ALTEON has certain rights to, subject to various licenses it has granted, and has developed substantial information and scientific data relating to, the Compound for a variety of other uses under a different mechanism of action. C. ALTEON is interested in obtaining: (i) the right to commercialize the Compound for use in the Field pursuant to the Licensed Patents and Licensed Technology, and (ii) an option, subject to the rights of Monsanto, to obtain a license to the Other Patents. D. WASHINGTON and ALTEON are entering into this Agreement to provide for ALTEON to conduct further research and development of the Compound for use in the Field, for ALTEON and WASHINGTON, acting through its Investigators (as defined below), to jointly collaborate on such further research and development, for WASHINGTON to license, and ALTEON to obtain a license for, the use and sale of products developed from such research and development and for WASHINGTON to grant, and ALTEON to obtain, an option, subject to the rights of Monsanto, to obtain a license to use and sell products covered by the Other Patents. NOW, THEREFORE, in consideration of the various promises and undertakings set forth herein, the Parties agree as follows: ARTICLE 1 - DEFINITIONS As used herein, capitalized terms shall have the following meanings: 1.1 "Affiliate", with respect to any Party, shall mean any person or entity controlling, controlled by, or under common control with, such Party. For these purposes, "control" shall refer to (i) the possession, directly or indirectly, of the power to direct the management or policies of a person or entity, whether through the ownership of voting securities, by contract or otherwise or (ii) the ownership, directly or indirectly, of at least 50% of the voting securities or other ownership interest of a person or entity. 1.2 "ALTEON Research Program" shall mean any research and development conducted by or on behalf of ALTEON pursuant to this Agreement which relates to the Compound in the Field. 1.3 "Commercial Sale" shall mean any sale which transfers to a purchaser physical possession and title to any Products in any country in the Territory by ALTEON or a sublicensee of ALTEON after all required marketing and pricing approval has been granted by the governing health authority of such country. -1- 7 Exhibit 10.10 1.4 "Compound" shall mean the chemical entity known as pimagedine, also known as aminoguanidine. 1.5 "Dosage Forms" shall mean the three (3) dosage forms in which Products may be developed, comprised of (i) topical (including any and all external applications); (ii) oral (including any ingestible form); and (iii) injectable (which shall include any dosage form other than topical or oral, including, without limitation, suppository, patch, depot, implant or pessary). When used in the singular, "Dosage Form" shall mean any of the three Dosage Forms. 1.6 "Effective Date of this Agreement" shall mean the date first written above. 1.7 "Field" shall mean all pharmaceutical and health care industry applications of the Licensed Patents and the Licensed Technology relating to the use of the Compound for therapeutic applications affected by iNOS/iCOX inhibition. 1.8 "First Commercial Sale" shall mean the first Commercial Sale of a Product in any country in the Territory. 1.9 "Goldman Patent" shall mean U.S. Patent No. 5,317,040 issues May 31, 1994 to William E. Goldman, entitled "Method for the Treatment of Pertussis with Aminoguanidine", which has been assigned to WASHINGTON, including any substitutions, extensions, renewals, continuations, continuations-in-part, divisions, patents-of-additions, and/or reissues thereof. 1.10 "Heart Graft Project" shall mean that certain research project conducted as a collaboration between Dr. J.A. Williamson and Dr. Ferguson at WASHINGTON, with funding from Monsanto, relating to the potential use of aminoguanidine to control heart graft rejection, the results of which are the subject of the following publications: Worrall et al., Abstract: "Nitric Oxide Mediates Increased Graft and Systemic Endothelial Permeability During Early Cardiac Transplant Rejection", Vol. 90, No. 4, Part 2, Oct 94. Circulation; Worrall et al, "Modulation of In-Vivo Alloreactivity by Inhibition of Inducible Nitric Oxide Synthase", J. Exp. Med. Vol 181, Jan 95; Worrall et al, Graft and Systemic Endothelial Barrier Dysfunction During Early Allograft Rejection: Prevention by Inhibition of Inducible Nitric Oxide Synthase, in press at J. Clin. Med. 1.11 "Initial Product" shall mean the first Product which reaches the applicable stage of development for sale. 1.12 "Invention" shall mean any new or useful process, manufacture, compound or composition of matter, patentable or unpatentable, or any improvement thereof, conceived or first reduced to practice, or demonstrated to have utility during the conduct of any Sponsored Research Program or any ALTEON Research Program. 1.13 "Inventors" shall mean the inventors named on WASHINGTON's current United States patents and patent applications as set forth in Exhibit A. 1.14 "Investigator(s)" shall mean J.R. Williamson, J.A. Corbett, and M.L. McDaniel, so long as they are associated with WASHINGTON, and any other University Personnel who become involved in any Sponsored Research Programs or -2- 8 Exhibit 10.10 who otherwise agree to become involved in the collaboration between ALTEON and WASHINGTON pursuant to this Agreement. 1.15 "Joint Invention" shall mean any Invention for which it is determined, in accordance with applicable law, that both: (i) employees or agents of ALTEON or any other persons obligated to assign such Invention to ALTEON, and (ii) employees or agents of WASHINGTON or any other persons obliged to assign such Invention to WASHINGTON, are joint inventors of such Invention. 1.16 "Licensed Patents" shall mean any current and future patent or patent application, or portion thereof, owned or controlled by WASHINGTON by way of transfer of rights from any Investigator or Inventor or jointly owned or controlled by ALTEON and WASHINGTON by way of transfer of rights from any Investigator claiming a therapeutic use for the Compound in the Field throughout the Territory, including any substitutions, extensions, renewals, continuations, continuations-in-part, divisions, patents-of-additions, and/or reissues thereof, and any current and future patent or patent application, or portion thereof, which is a foreign counterpart in any country in the Territory to any of the foregoing, including any substitutions, extensions, renewals, continuations, continuations-in-part, divisions, patents-of-additions, and/or reissues thereof; provided that continuations-in-part and patents-of-additions filed after the Effective Date of this Agreement shall only be included in Licensed Patents if they claim a therapeutic use of the Compound in the Field. Only those claims of any Licensed Patents which cover the Compound, either alone or in conjunction with other compounds, shall be included in Licensed Patents, and for those claims which cover the Compound in conjunction with other compounds, only that portion of the claims which relates solely to the Compound, shall be included in Licensed Patents. Any claim or any portion of any claim, in any Licensed Patent which does not cover the Compound shall not be included in Licensed Patents and shall not be licensed under this Agreement. WASHINGTON's current U.S. and foreign patents and patent applications which claim a therapeutic use for the Compound and are included in Licensed Patents, and which exist on the Effective Date of this Agreement, are set forth on Exhibit A. The Other Patents are not included in Licensed Patents. 1.17 "Licensed Technology" shall mean any and all information, and all patentable and non-patentable inventions (including, without limitation, all Inventions and Joint Inventions), improvements, discoveries, claims, formulae, processes, methods, trade secrets, technologies, data and know-how relating to a therapeutic use of the Compound in the Field owned or controlled by WASHINGTON by way of transfer of rights from any Investigator or Inventor or to which WASHINGTON has the right to grant licenses or sublicenses by way of transfer of rights from any Investigator or Inventor before or during the term of this Agreement and: (i) relating to or resulting from research projects conducted at WASHINGTON by any of the Inventors or any of WASHINGTON's Investigators involving the Compound in the Field listed and described in Exhibit B, provided that, with respect to research conducted after the Effective Date of this Agreement, excluding any research conducted using commercial third party funding, or (ii) claimed, covered or disclosed in any patent or patent application listed in Exhibit A which relates to the research projects described in Exhibit B, or (iii) relating to or derived from any Sponsored Research Program or any ALTEON Research Program. Both Parties acknowledge and agree that WASHINGTON has, and may hereinafter develop, certain non-public information relating to iNOS inhibition with the Compound, including the results of studies, which is valuable Licensed Technology and which is adequate and sufficient consideration for the license granted in this Agreement. The Heart Graft Project and the know-how related to the invention disclosed and claimed in the Goldman Patent are not included in Licensed Technology. -3- 9 Exhibit 10.10 1.18 "Monsanto" shall mean Monsanto Company, a Delaware corporation, with a principal place of business at 800 North Lindbergh, St. Louis, Missouri, or such other entity who holds rights pursuant to that certain Biomedical Research Agreement with WASHINGTON dated July 1, 1982, as amended. 1.19 "Net Sales" shall mean the gross amount invoiced for all Products sold by ALTEON and/or its Affiliates in arm's length sales to unrelated third parties (excluding sales to sublicensees for their resale), less deductions for: (a) commissions, trade, quantity and cash discounts or rebates actually allowed or given; (b) credits, allowances or refunds given or made for rejected, outdated or returned Products; (c) any tax or government charge (other than an income tax) levied on the sale, transportation or delivery of a Product and borne by the seller thereof; and (d) any prepaid and invoiced charges for freight, postage, shipping, import or export taxes, insurance or charges for returnable containers. 1.20 "Other Patents" shall mean: (i) the Goldman Patent, and (ii) any patent which may issue at any time during the term of this Agreement resulting from the Heart Graft Project which is owned or controlled by WASHINGTON. 1.21 "Party" shall mean WASHINGTON or ALTEON and, when used in the plural, shall mean WASHINGTON and ALTEON. 1.22 "Post-Commercialization Income" shall mean the gross revenues received by ALTEON and/or its Affiliates from any sublicensee, after the First Commercial Sale of a Product by such sublicensee, for all Products sold by such sublicensee in arm's length sales to unrelated third parties, excluding, however, any portion thereof that is attributable to ALTEON's full manufacturing cost for the supply of bulk materials or finished Product, including direct materials, direct labor and manufacturing overhead. 1.23 "Pre-Commercialization Income" shall mean the gross revenues received by ALTEON and/or its Affiliates from any sublicensee, prior to the First Commercial Sale of a Product by such sublicensee, in connection with the grant of a sublicense to such sublicensee of the Licensed Technology and/or Licensed Patents, or any part thereof. 1.24 "Product" shall mean any product comprising the Compound, the use or sale of which is: (i) based upon, derived from, identified through or related to any Licensed Technology; and/or (ii) covered by one or more Licensed Patents and would infringe a Valid Claim thereof. 1.25 "Publication" means any written or oral publication or disclosure resulting from or involving the Licensed Technology or the subject matter of any Sponsored Research Program or ALTEON Research Program, and includes but is not limited to a publication or disclosure in books, journals, theses, trade publications, scientific meetings, poster sessions, and symposia. 1.26 "Sponsored Research Program" shall mean any research conducted by WASHINGTON, acting through the laboratories of any Investigator(s), in collaboration with ALTEON pursuant to Section 3.1 this Agreement. -4- 10 Exhibit 10.10 1.27 "Territory" shall mean the entire world. 1.28 "University Personnel" means any University employee, student or consultant who participates in any Sponsored Research Program or any ALTEON Research Program in any manner or who acquires knowledge of any test data, clinical information or any other information resulting from any Sponsored Research Program or any ALTEON Research Program which is deemed a trade secret or confidential or proprietary to ALTEON or WASHINGTON, such as any professor, technician, any associate or student (including a pre-or post-doctoral student), any independent contractor (including any consultant under an obligation of confidentiality), or any research collaborator. 1.29 "Valid Claim" shall mean a claim of any issued or granted Licensed Patent which has not been held invalid or unenforceable by final decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which is not admitted to be invalid or unenforceable through reissue, disclaimer or otherwise. ARTICLE 2 - REPRESENTATIONS AND WARRANTIES 2.1 Representations and Warranties of Both Parties. Each Party represents and warrants to the other Party that: (i) it is free to enter into this Agreement; (ii) in so doing, it will not violate any other agreement to which it is a party; and (iii) it has taken all corporate action necessary to authorize the execution and delivery of this Agreement and the performance of its obligations under this Agreement. 2.2 Representations and Warranties of WASHINGTON. WASHINGTON hereby represents and warrants that, to the best of its knowledge, information and belief, after due inquiry: (a) It is the owner of all of the Licensed Patents listed on Exhibit A, and has the exclusive right to grant licenses therefor; (b) It is the owner of the Goldman Patent, and has the exclusive right to grant licenses therefor, subject to the rights of Monsanto, and the Goldman Patent has not been licensed to any third party as of the date of this Agreement; (c) It is the owner of the results of the Heart Graft Project, and will own any patents resulting therefrom, subject to the rights of Monsanto, no patent applications have been made and no patents have issued which have resulted from the Heart Graft Project; (d) It is the owner of, or is the licensee of, all of the Licensed Technology in existence on the date of this Agreement, and has the right to grant licenses or sublicenses therefor; (e) It has not entered into any agreement with any third party which is in conflict with the rights granted to ALTEON pursuant to this Agreement. WASHINGTON hereby represents and warrants that, to the best of its knowledge, information and belief: -5- 11 Exhibit 10.10 (f) All the Licensed Patents listed on Exhibit A are in full force and effect and have been maintained to date; (g) There are no asserted or unasserted claim or demand which can be enforced against the Licensed Patents listed on Exhibit A; (h) None of the Licensed Patents listed on Exhibit A infringe upon any patent or other proprietary rights of any other third party; and 2.3 Representation and Covenant Regarding U.S. Government Funding. The Parties acknowledge that WASHINGTON has received United States government funding with respect to the Compound in the Field which requires certain rights to be granted to the United States government pursuant to 35 U.S.C. Sections 200-212. In addition, WASHINGTON represents and warrants to ALTEON that WASHINGTON has complied with all government rules and regulations relating to reporting requirements thereunder, and WASHINGTON covenants and agrees to continue to comply with all such reporting requirements during the term of this Agreement. 2.4 Disclaimer of Other Warranties. EXCEPT AS EXPRESSLY PROVIDED IN SECTIONS 2.2 AND 2.3, NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION MADE, OR WARRANTY GIVEN, BY WASHINGTON THAT ANY PATENT WILL ISSUE BASED UPON ANY PENDING PATENT APPLICATION, THAT ANY PATENT WHICH ISSUES WILL BE VALID, OR THAT THE USE OF THE COMPOUND, THE RESULTS OF ANY SPONSORED RESEARCH PROGRAM OR THE PRODUCTS WILL NOT INFRINGE THE PATENT OR PROPRIETARY RIGHTS OF ANY THIRD PARTY. FURTHERMORE, WASHINGTON MAKES NO OTHER REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE LICENSED TECHNOLOGY, THE LICENSED PATENTS, THE COMPOUND, THE RESULTS OF ANY SPONSORED RESEARCH PROGRAM OR THE PRODUCTS, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. WASHINGTON SHALL NOT BE LIABLE FOR ANY DIRECT, CONSEQUENTIAL, PUNITIVE OR OTHER DAMAGES SUFFERED BY ALTEON OR ANY OTHER PERSON RESULTING FROM THE USE OF THE COMPOUND OR ANY PRODUCT. ARTICLE 3 - RESEARCH COLLABORATION AND DEVELOPMENT EFFORTS 3.1 Sponsored Research Programs. During the term of this Agreement, ALTEON may request WASHINGTON, acting through the laboratories of any Investigator(s), to conduct research programs in the use of the Compound in the Field. In such event, ALTEON and WASHINGTON shall negotiate in good faith concerning the terms and conditions of such research program, including a research plan and budget, term of the research program, funding to be provided by ALTEON and the University Personnel to be assigned to the research program. If the Parties reach an agreement for such research program, such research program shall be deemed a Sponsored Research Program under this Agreement and shall be subject to all of the terms and conditions applicable thereto contained in this Agreement. Any such Sponsored Research Program shall be conducted only at WASHINGTON by WASHINGTON's Investigator(s) and other University Personnel. 3.2 ALTEON Research Programs. During the term of this Agreement, ALTEON shall initiate development of the Compound in each Dosage Form and conduct such ALTEON Research Programs which it deems appropriate, in its sole judgment, to achieve the milestone targets provided in Section 5.3 and to develop and market commercial applications of the Licensed Technology and the Licensed Patents. ALTEON shall have the sole discretion to make all decisions relating to the research, development, marketing and other commercialization efforts of the Compound and Products in the Field, including without limitation, the sequence of the Dosage Form(s) to be pursued. ALTEON shall not be obligated to pursue the -6- 12 Exhibit 10.10 development of more than one Dosage Form at any time prior to the filing of an NDA for the previously developed Dosage Form(s). Notwithstanding the foregoing, ALTEON shall not be obligated to develop any Dosage Form for which it determines that there is not a sufficient scientific or commercial basis to warrant such development. 3.3 Collaboration. (a) WASHINGTON's Investigators shall collaborate with ALTEON, as reasonably requested by ALTEON, on any ALTEON Research Programs. WASHINGTON's Investigators agree to meet with ALTEON's science personnel from time to time and for telephone consultations regarding such ALTEON Research Programs. In addition, WASHINGTON, acting through the laboratories of its Investigator(s), shall collaborate with ALTEON on any Sponsored Research Programs and any other studies or research projects being conducted by WASHINGTON's Investigators which relate to the Compound in the Field. (b) Prior to WASHINGTON or any of its Investigator(s) accepting any commercial third party funding for further research involving the Compound in the Field, WASHINGTON or such Investigator(s), as the case may be, shall notify ALTEON of its or their interest in pursuing such further research and give ALTEON the opportunity to provide the necessary funding for same. 3.4 Exchange of Information. (a) It is the intent of the Parties that there be a timely and full exchange of all Licensed Technology, and thereafter continuing exchange of all information arising from each Sponsored Research Program and ALTEON Research Program, subject to the terms and conditions of this Agreement. Within thirty (30) days after the Effective Date of this Agreement and after any request therefor by a Party, the other Party and, with respect to WASHINGTON, WASHINGTON's Investigators, shall provide to the requesting Party all data and information relating to the Licensed Technology as such requesting Party may request from time to time. Within thirty (30) days after the end of each calendar quarter during the term of this Agreement: (i) WASHINGTON's Investigators shall provide ALTEON with a written report setting forth the progress of each study being conducted by such Investigator(s) under any Sponsored Research Program then pending, and any other study or research project being conducted by such Investigator(s) which relates to the Compound in the Field. Upon completion or termination of a study or a Sponsored Research Program, WASHINGTON's Investigators shall provide ALTEON with a copy of all results thereof; and (ii) ALTEON shall provide WASHINGTON with a written report setting forth the progress of all ALTEON Research Programs. In addition, ALTEON and WASHINGTON's Investigators shall immediately disclose to the other any critical data or development which would have a significant effect, whether positive or negative, on the overall prospects of any research being conducted on the Licensed Technology. (b) The Parties recognize that ALTEON may have development/marketing partners and/or licensees or sublicensees for the Licensed Technology. WASHINGTON hereby grants ALTEON the right to share data and information developed by WASHINGTON relating to the Licensed Technology with such third parties, subject to appropriate confidentiality agreements, which conform to the restrictions on confidentiality contained in this Agreement. -7- 13 Exhibit 10.10 ARTICLE 4 - LICENSE GRANT 4.1 Grant of License. (a) Subject to the terms and conditions of this Agreement, WASHINGTON grants to ALTEON an exclusive license throughout the Territory, with the right to grant sublicenses, to use and sell Products in the Field, under the Licensed Technology and Licensed Patents, except that such license shall only extend to any New WASHINGTON Technology, as defined in Section 4.2, if ALTEON has exercised the option set forth in Section 4.2 with respect thereto. (b) The Parties acknowledge and agree that the license granted in this Section 4.1 does not include any rights under the Other Patents, and this Agreement does not confer upon ALTEON any rights with respect to the Other Patents other than as provided in Section 4.3. 4.2 ALTEON Option for New WASHINGTON Technology. WASHINGTON grants to ALTEON an exclusive option to acquire an exclusive license, pursuant to the terms of this Agreement, to any Licensed Technology relating to or resulting from research projects conducted at WASHINGTON by any of the Inventors or any of WASHINGTON's Investigators after the Effective Date of this Agreement (excluding any research conducted using commercial third party funding), involving the Compound in the Field listed and described in Exhibit B ("New WASHINGTON Technology"). WASHINGTON shall provide ALTEON with written notice of any New WASHINGTON Technology, together with sufficient information to allow ALTEON to evaluate such New WASHINGTON Technology. ALTEON may exercise such option with respect to such New WASHINGTON Technology by sending written notice to WASHINGTON of such exercise within 90 days after ALTEON receives such notice from WASHINGTON with respect to such New WASHINGTON Technology. Upon the exercise of this option with respect to any such New WASHINGTON Technology, such New WASHINGTON Technology shall automatically be included in the license granted in Section 4.1 and shall be subject to all of the terms and conditions of this Agreement. 4.3 ALTEON Option for Other Patents. Subject to the prior rights of Monsanto pursuant to that certain Biomedical Research Agreement between Monsanto and WASHINGTON dated July 1, 1982, as amended, WASHINGTON hereby grants to ALTEON an exclusive option, on the terms hereinafter set forth, to acquire an exclusive license to any Other Patents upon reasonable terms to be negotiated. If during the term of this Agreement WASHINGTON becomes interested in licensing any Other Patents to any third party for exploitation in the Territory, WASHINGTON shall give written notice to ALTEON of its interest in negotiating such license together with sufficient information regarding such Other Patents which is reasonably necessary for ALTEON to make an informed decision regarding such license. ALTEON shall have sixty (60) days after receipt of the notice relating to such Other Patents to notify WASHINGTON of its election to exercise its option with respect to such Other Patents. If ALTEON elects to exercise such option, the Parties shall negotiate the terms of such license in good faith for a period of at least 120 days after ALTEON's election of such option. If the parties have not reached an agreement after such time, then WASHINGTON shall be free to negotiate such license with a third party, provided, however, that any such license shall not conflict with the license and other rights granted to ALTEON under this Agreement. In addition, WASHINGTON shall advise ALTEON of the terms of any such license to a third party. 4.4 Reservation of Rights. The license granted in Section 4.1 is exclusive to ALTEON, except that WASHINGTON reserves the right to use and permit the use of the Licensed Technology and the Licensed Patents by non-profit organizations, without cost to ALTEON and subject to the confidentiality -8- 14 Exhibit 10.10 provisions of this Agreement, solely for educational and research purposes on a non-commercial basis. 4.5 Retained Rights of U.S. Government. Any license granted to ALTEON pursuant to this ARTICLE 4 shall be subject to the royalty free, non-exclusive license granted to the United States government by WASHINGTON pursuant to 35 U.S.C. 200(c)(4) and for any Licensed Patents claiming any invention subject to 35 U.S.C. Section 201, and any federal laws and applicable regulations. 4.6 ALTEON's Development Efforts. ALTEON shall use all reasonable commercial efforts to develop and commercialize Products based on the rights and license granted under this Agreement. ALTEON shall keep WASHINGTON informed annually about its development plans and its progress on pursuing such development plans, including submitting the reports required of ALTEON pursuant to Section 3.4(a)(ii). Notwithstanding any of the foregoing, ALTEON shall not be obligated to develop any Dosage Form or Product for which it determines that there is not a sufficient scientific or commercial basis to warrant such development. However, in the event that ALTEON decides not to pursue the development of any Dosage Form, other than due to its good faith determination that there is an insufficient scientific or commercial basis to warrant such development, ALTEON shall immediately notify WASHINGTON of such decision and ALTEON shall terminate the license granted under this Agreement with respect to such Dosage Form pursuant to Section 11.3. ARTICLE 5 - MILESTONE, ROYALTY AND OTHER PAYMENTS 5.1 Up-front Payments. As partial consideration to WASHINGTON for the licenses and other rights granted to ALTEON under this Agreement, ALTEON shall pay to WASHINGTON: (a) the sum of [C.I] upon the execution of this Agreement, and (b) the sum of [C.I.] no later than January 2, 1996. Such sums shall be non-refundable and non-creditable against royalties. 5.2 Annual Pre-Commercial Payments. As further consideration for the licenses and other rights granted to ALTEON under this Agreement, each year during the term of this Agreement and until commencement of the first full calendar year after the First Commercial Sale of the Initial Product, ALTEON shall pay to WASHINGTON the sum of [C.I.] no later than June 30th of each year, commencing in 1996. Such sums shall be non-refundable and non-creditable against royalties. 5.3 Milestone Payments. As further consideration for the licenses and other rights granted to ALTEON under this Agreement, ALTEON shall pay WASHINGTON the following milestone payments within six (6) months following the first occurrence of each event set forth below with respect to each Initial Product in each Dosage Form: (a) [C.I.] upon commencement of Phase I/II clinical trials in the United States; (b) [C.I.] upon commencement of Phase III clinical trials in the United States; and (c) [C.I.] upon filing an NDA in the United States; and (d) [C.I.] upon receipt of NDA approval from the FDA, including any required marketing and pricing approval. -9- 15 Exhibit 10.10 With respect to the first Initial Product in the first Dosage Form, such payments shall be made in any event no later than (i) June 30, 1997 with respect to the payment due under Section 5.3(a), (ii) December 31, 1997 with respect to the payment due under Section 5.3(b), and (iii) December 31, 1998 with respect to the payment due under Section 5.3(c). 5.4 Credit Against Royalties. With respect to any milestone payments made pursuant to Section 5.3, for each Initial Product in each Dosage Form ALTEON shall be entitled to a credit against running royalties due under Section 5.6 of this Agreement for such Product in the Territory in each of the first ten calendar semi-annual periods following the First Commercial Sale of such Product in an amount equal to the lesser of: (i) [C.I.] of the aggregate amount of such milestone payments, or (ii) the amount of the royalties due for such Product for such period in excess of the minimum royalties due for such period. Such credit, if any, shall be applied when the royalties for such semi-annual period are due pursuant to Section 6.1. Such credit may only be taken against royalties otherwise due for Products of the same Dosage Form as that for which the milestone payments were made. Any credit not taken or eligible to be taken in the applicable semi-annual period shall expire and shall not be carried into any other periods. 5.5 Pre-Commercialization Income from Sublicensees. (a) In the event that ALTEON and/or its Affiliates receive Pre-Commercialization Income from any sublicensee, ALTEON shall pay to WASHINGTON: (i) a first amount equal to [C.I.] of the aggregate Pre-Commercialization Income received by ALTEON and/or its Affiliates which such sublicensee may credit against its running royalties, plus (ii) a second amount equal to [C.I.] of the aggregate of all other Pre-Commercialization Income received by ALTEON and/or its Affiliates, but such second amount shall then be reduced by the amount of all payments made by ALTEON to WASHINGTON pursuant to Sections 5.1, 5.2 and 5.3 through the last day of the calendar semi-annual period in which such payment of such second amount of other Pre-Commercialization Income was received (less any such payments previously applied against previously received Pre-Commercialization Income). To the extent that any Pre-Commercialization Income can be identified to relate specifically to one or more Dosage Forms, the amount by which [C.I.] of the aggregate Pre-Commercialization Income is reduced shall be limited only to the milestone payments made with respect to such Dosage Form(s). Such payments shall be made within thirty (30) days after the end of the calendar semi-annual period in which it was received. In the event that any payments made by ALTEON pursuant to this Section 5.5 are made before all payments due under Sections 5.1, 5.2 and 5.3 have been accrued, such payment(s) under this Section 5.5 shall be deemed to be a prepayment of any payments subsequently due under Sections 5.1, 5.2 and 5.3. (b) By way of illustration of the application of Section 5.5(a), if ALTEON has paid a total of [C.I.] to WASHINGTON pursuant to Sections 5.1, 5.2 and 5.3 at the time that it grants a sublicense to Company X, and the sublicense provides for an up-front payment of [C.I.] which is not creditable against running royalties, then ALTEON will pay WASHINGTON [([C.I.] of [C.I.]) - [C.I.]], or [C.I.]. Such payment will be deemed to be a prepayment of subsequent payments due under 5.1, 5.2 or 5.3. Thereafter, as payments become due under Sections 5.1, 5.2 or 5.3, the [C.I.] payment will be applied against such payments then due under 5.1, 5.2 or 5.3 until it is fully used. So, if a milestone payment of [C.I.] becomes due in the following period, ALTEON shall make no additional payment, but the amount of such prepayment shall be reduced by the amount of such milestone payment, such that a prepayment of [C.I.] - [C.I.], or [C.I.], remains. -10- 16 Exhibit 10.10 In addition, if ALTEON subsequently receives an additional up-front or milestone payment of [C.I.] from Company X, and in the interim ALTEON has paid to WASHINGTON an additional [C.I.] in payments pursuant to Section 5.1, 5.2 or 5.3, ALTEON will pay WASHINGTON [([C.I.] of [C.I.]) - [C.I.]], or [C.I.], from which ALTEON may deduct the remaining [C.I.] prepayment. 5.6 Running Royalties. As further consideration of the license and other rights granted to ALTEON under this Agreement, ALTEON shall pay to WASHINGTON a royalty, commencing on the First Commercial Sale of a Product by ALTEON, its Affiliates or its sublicensees, as follows: (a) For Commercial Sales made by ALTEON and its Affiliates, ALTEON shall pay to WASHINGTON a royalty equal to [C.I.] of the annual Net Sales for the first [C.I.] in Net Sales for each calendar year, and [C.I.] of the annual Net Sales for any Net Sales over [C.I.] for such calendar year. (b) For Commercial Sales made by any sublicensee of ALTEON or its Affiliates, ALTEON shall pay to WASHINGTON a royalty equal to [C.I.] of ALTEON's Post-Commercialization Income for such period. (c) For any Product relating solely to Joint Inventions, and which does not utilize any Licensed Technology other than Joint Inventions, or which is not covered by a Licensed Patent other than jointly owned Licensed Patents, the royalty rates set forth in Sections 5.6(a) and 5.6(b) shall be reduced by [C.I.] with respect to such Product in the Territory. (d) The Parties intend and expect that they will be able to secure patents covering the Products. However, during any period when (i) the use or sale of a Product would not infringe a Valid Claim of any Licensed Patent in the country in the Territory where it is used or sold such that a third party would be permitted to sell competing products, and (ii) either (A) no patent application has been filed which, if issued, would cover such Product in such country, then the royalty rates set forth in Sections 5.6(a) and 5.6(b) shall be reduced by [C.I.] with respect to such Product in such country during such period, or (B) a patent application has been filed which, if issued, would cover such Product in such country, then the royalty rates set forth in Sections 5.6(a) and 5.6(b) shall be reduced by [C.I.] with respect to such Product in such country during the pendency of such patent application. In the event that a patent application has been filed and is pending for a period of time such that, the Parties agree, in good faith, that it is reasonable to believe that no patent will be issued from such patent application, then thereafter, the royalty rates shall be reduced as provided in clause (A) of this Section. (e) During any period when either: (i) the Compound, or (ii) any other compound licensed by WASHINGTON, is available for use or sale in any country in the Territory by a third party (other than an Affiliate or sublicensee of ALTEON) for use in the Field in such a manner that such use or sale would not infringe a Valid Claim of any Licensed Patent in such country and ALTEON experiences effective competition which has a substantial negative impact on sales of Products by ALTEON or any of its Affiliates or sublicensees, the royalty rates set forth in Sections 5.6(a) and 5.6(b) shall be reduced by [C.I.] with respect to such Product in such country. ALTEON shall provide to WASHINGTON a written notice of any event covered by this Section 5.6(e), which shall include an explanation of the facts and information which give rise to such event. (f) Notwithstanding the foregoing, ALTEON shall only be entitled to a [C.I.] reduction of the royalty rate once with respect to any Product in any country in the Territory pursuant to any provision in this Agreement. -11- 17 Exhibit 10.10 5.7 Annual Minimum Royalties. During each full calendar year after the First Commercial Sale of the Initial Product in the United States during the term of this Agreement, ALTEON shall pay to WASHINGTON minimum royalties as follows: (a) For the first full calendar year after the First Commercial Sale in the United States, the minimum royalty shall be [C.I.]; (b) For the second full calendar year after the First Commercial Sale in the United States, the minimum royalty shall be [C.I.]; and (c) For the each full calendar year thereafter, and until this Agreement terminates with respect to all Products in the United States, the minimum royalty shall be [C.I.]. One-half of the applicable annual minimum royalty shall be paid within thirty (30) days after the end of the first semi-annual period in such calendar year, and the balance shall be paid within thirty (30) days after the end of the second semi-annual period in such calendar year. ALTEON shall be entitled to a full credit of the annual minimum royalty against running royalties due for the applicable calendar year pursuant to Section 5.6. 5.8 Obligation to Pay Royalties. (a) The Parties acknowledge and agree that ALTEON owns or controls separate intellectual property rights relating to the use of the Compound using different mechanisms of action and making different claims in its patents and patent applications relating to the Compound. The Parties agree that ALTEON shall only be obligated to pay royalties to WASHINGTON on the sales of products making use of the Compound if the allowed claims for the sale and promotion of such products by the United States Food and Drug Administration or the successor thereto, or its equivalent in any other country, is consistent with the claims contained in the Licensed Patents with respect to the Compound, and such sales and promotion are based upon such claims. ALTEON shall use all reasonable commercial efforts to develop formulations of Products which differ from any formulations of other products making use of the Compound which may be marketed pursuant to claims of other patents so that there may be avoidance of doubt as to which products shall be governed by the Licensed Patents under this Agreement. (b) The obligation to pay royalties to WASHINGTON under this ARTICLE 5 is imposed only once with respect to the same unit of Product regardless of the number of Licensed Patents or Licensed Technology pertaining thereto. There shall be no obligation to pay royalties to WASHINGTON under this ARTICLE 5 on sales of Products between ALTEON, its Affiliates and its sublicensees, but in such instances the obligation to pay royalties shall arise upon the sale by ALTEON, its Affiliates or its sublicensees to unrelated third parties. Payments of running royalties due under this ARTICLE 5 based on Net Sales shall be deemed to accrue when Products are shipped or billed, whichever event shall first occur. Payments of running royalties due under this ARTICLE 5 based on Post-Commercialization Income shall be deemed to accrue when ALTEON receives such Post-Commercialization Income. -12- 18 ARTICLE 6 - PAYMENTS AND REPORTS 6.1 Payment. All running royalty payments due pursuant to Section 5.6(a) shall be paid semi-annually within sixty (60) days after the end of each June 30 and December 31 of each calendar year. All running royalty payments due pursuant to Section 5.6(b) shall be paid semi-annually within thirty (30) days after the end of each June 30 and December 31 of each calendar year. Each such payment shall be accompanied by a statement for each Dosage Form of the amount of Net Sales and Post-Commercialization Income during such semi-annual period, the amount of royalties due on such Net Sales and Post-Commercialization Income and the amount of any credits being applied to such royalties. 6.2 Mode of Payment. ALTEON shall make all payments required under this Agreement in the United States in United States Dollars. The royalty payments due shall be translated at the rate of exchange at which United States Dollars are listed in The Wall Street Journal for the currency of the country in which the royalty is accrued for the last business day of the calendar semi-annual period in which such sales were made. 6.3 Late Payments. ALTEON shall pay interest to WASHINGTON on the aggregate amount of any payments that are not paid on or before the date such payments are due under this Agreement at a rate per annum equal to the lesser of: (i) the prime rate of interest as published in the United States in The Wall Street Journal under the caption "Money Rates" on the date such payment was due, plus three percent (3%), or (ii) the highest rate permitted by applicable law; calculated on the actual number of days such payment is late. 6.4 Records Retention. ALTEON and its Affiliates shall keep complete and accurate records pertaining to the sale of Products in the Territory and covering all transactions from which Net Sales, Pre-Commercialization Income or Post-Commercialization Income are derived for a period of three calendar years after the year in which such sales occurred, and in sufficient detail to permit WASHINGTON to confirm the accuracy of royalty calculations hereunder. 6.5 Audit Request. At the request and expense of WASHINGTON, ALTEON and its Affiliates shall permit an independent, certified public accountant appointed by WASHINGTON and acceptable to ALTEON or its Affiliate, at reasonable times and upon reasonable notice, to examine those records and all other material documents relating to or relevant to Net Sales, Pre-Commercialization Income and Post-Commercialization Income in the possession or control of ALTEON or its Affiliates, for a period of three years after such royalties have accrued, as may be necessary to: (i) determine the correctness of any report or payment made under this Agreement; or (ii) obtain information as to the royalties payable for any calendar semi-annual period in the case of ALTEON's failure to report or pay pursuant to this Agreement. Said accountant shall not disclose to WASHINGTON any information other than information relating to said reports, royalties, and payments. Results of any such examination shall be made available to ALTEON if a claim is made for royalties underpaid by ALTEON. WASHINGTON shall bear the full cost of the performance of any such audit, unless such audit demonstrates underpayment of royalties by ALTEON of more than ten percent (10%) from the amount of the original royalty payment made by ALTEON. In such event, ALTEON shall bear the full cost of the performance of such audit. 6.6 Taxes. In the event that ALTEON or its Affiliates are required to withhold any tax to the revenue authorities in any country in the Territory regarding any payment to WASHINGTON due to the laws of such country, such amount shall be deducted by ALTEON or its Affiliates, and it shall notify WASHINGTON and -13- 19 Exhibit 10.10 promptly furnish WASHINGTON with copies of any tax certificate or other documentation evidencing such withholding. ARTICLE 7 - OWNERSHIP; PATENT PROSECUTION 7.1 WASHINGTON Ownership. Except as otherwise provided in Section 7.2 or 7.3, WASHINGTON shall retain all right, title and interest in and to the Licensed Technology and the Licensed Patents, regardless of which party prepares and prosecutes the applications associated therewith, or maintains the patents, copyrights or other intellectual property rights related to the Licensed Technology or Licensed Patents, subject to the license granted to ALTEON under Section 4.1. Rights to Inventions made solely by employees of WASHINGTON using WASHINGTON's facilities shall belong to WASHINGTON. WASHINGTON agrees to promptly disclose to ALTEON any such Inventions. 7.2 ALTEON Ownership. Rights to Inventions made solely by employees of ALTEON using ALTEON's facilities shall belong to ALTEON. ALTEON agrees to promptly disclose to WASHINGTON any such Inventions. 7.3 Joint Ownership. Rights to Inventions which were made jointly during the performance of this Agreement by University Personnel or other inventors owing a duty to assign to WASHINGTON and by employees of ALTEON shall belong jointly to WASHINGTON and to ALTEON. Such Joint Inventions shall be subject to the terms and conditions of this Agreement. 7.4 Patent Prosecution and Maintenance. (a) WASHINGTON shall continue to have full responsibility for and shall control the preparation and prosecution of all patent applications and the maintenance of all patents related to the Licensed Technology and included in the Licensed Patents. WASHINGTON agrees to take all actions reasonably necessary to diligently prosecute and maintain any patents or patent applications in the countries listed on Exhibit C. ALTEON and WASHINGTON shall mutually determine the additional countries, if any, where patent applications will be filed and prosecuted, and where the patents will be maintained. The Parties acknowledge and agree that they intend for WASHINGTON to file and prosecute patent applications and maintain patents in all major commercial markets where viable use patent protection is available (such countries, including the countries listed on Exhibit C, shall be referred to as "Use Patent Countries"). If the laws affecting patent protection or maintenance costs change in any Use Patent Country, the Parties shall reassess the need to continue to file and prosecute patent applications and maintain patents in such country. If the Parties determine to discontinue such filing, prosecution and maintenance in any such country, such country shall no longer be deemed a Use Patent Country. (b) As of the Effective Date of this Agreement, ALTEON shall reimburse WASHINGTON for all reasonable fees and expenses (including, without limitation, legal fees, filing and maintenance fees or other governmental charges) incurred on or after January 1, 1995 in connection with the filing and prosecution of such patent applications and maintenance of such patents, including patent applications and patents relating to Inventions and Joint Inventions. In addition, ALTEON shall reimburse WASHINGTON for all such reasonable fees and expenses incurred prior to the Effective Date in connection with the filing of the continuation-in-part application to U.S. Patent #[C.I.], which was filed on [C.I.]. WASHINGTON shall provide ALTEON with copies of all detailed statements it receives from its counsel for legal fees and expenses for ALTEON's review. If ALTEON does not notify WASHINGTON or the person or entity -14- 20 Exhibit 10.10 rendering the services of any issues, questions or discrepancies regarding such statement within thirty (30) days after receipt of such statement by ALTEON, the fees and expenses set forth in such statement shall be deemed reasonable. (c) WASHINGTON shall select qualified independent patent counsel (who shall be reasonably acceptable to ALTEON) to file and prosecute all patent applications required pursuant to Section 7.4(a). ALTEON or its representatives shall be entitled to meet and confer with such patent counsel at reasonable times and places. WASHINGTON shall promptly provide copies to ALTEON of any communications from any patent office relating to the Licensed Technology, and allow ALTEON and its patent counsel the opportunity to attend (either in person or by phone) any conferences (conducted in person or by phone) to be made with or to any patent office regarding the Licensed Technology. In addition, filing deadlines permitting, at least thirty (30) days prior to the filing of any patent application, amendment thereto, or response to any patent office action related to the Licensed Technology, WASHINGTON shall provide ALTEON with a copy of each such patent application, amendment or response and will provide ALTEON and its legal counsel with an opportunity to consult with WASHINGTON and its patent counsel regarding the filing and contents of any such application, amendment or response, and the advice and suggestions of ALTEON and its legal counsel shall be taken into consideration by WASHINGTON and its legal counsel in connection with such filing. However, WASHINGTON shall make every reasonable effort to obtain the concurrence of ALTEON regarding the content of any patent application, amendment thereto, or response to any patent office action related to the Licensed Technology prior to filing or submitting same. WASHINGTON shall also provide ALTEON with copies of any patentability search reports made by patent counsel, including patents located, a copy of each patent application, and each patent that issues thereon. (d) WASHINGTON agrees to provide promptly to ALTEON complete written disclosure of any Invention made by WASHINGTON. ALTEON and WASHINGTON shall mutually determine whether such Invention is patentable. If the Parties determine that such Invention is patentable, WASHINGTON shall proceed with the preparation and prosection of a patent application covering such Invention. (e) If ALTEON elects not to support any patent or patent application in any Use Patent Country in the Territory, ALTEON shall notify WASHINGTON in a timely manner and WASHINGTON may do so at its own expense. In such event, such patent or application in such country shall be considered as part of the Licensed Patents, and ALTEON shall be required to pay royalties for Products which would infringe a Valid Claim of such patent in such Use Patent Country pursuant to Section 5.6. (f) In the event that the Parties elect to file one or more patent applications comprising Joint Inventions, the Parties shall confer on how the preparation and prosecution of such applications shall be accomplished. Once the Parties agree on how to proceed with respect to the preparation and filing of patent applications comprising Joint Inventions, all other provisions of this Section 7.4 shall govern such preparation, filing, maintenance and prosecution. (g) Both Parties, including all University Personnel who agree to participate in a Sponsored Research Program or an ALTEON Research Program and sign a copy of this Agreement, agree to cooperate with the other Party to execute all lawful papers and instruments, to make all rightful oaths and declarations and to provide consultation and assistance as may be necessary in the preparation, prosecution, maintenance, and enforcement of all such patent applications and patents. -15- 21 Exhibit 10.10 ARTICLE 8 - PATENT ENFORCEMENT; INFRINGEMENT 8.1 Notification of Infringement. If either Party learns of an infringement or other use, rights or ownership claim or threatened infringement or other such claim by a third party with respect to any Licensed Patent or other Licensed Technology granted hereunder within the Territory (an "Infringement"), such Party shall promptly notify the other Party and shall provide such other Party with available evidence of such infringement. 8.2 Patent Enforcement. ALTEON shall have the first right, but not the duty, to institute infringement actions against third parties based on any Infringement. If ALTEON does not institute an infringement proceeding against an offending third party within ninety (90) days after receipt of notice from WASHINGTON, WASHINGTON shall have the right, but not the duty, to institute such an action. The costs and expenses of any such action (including fees of attorneys and other professionals) shall be borne by the Party instituting the action, or, if the Parties elect to cooperate in instituting and maintaining such action, such costs and expenses shall be borne by the Parties in such proportions as they may agree in writing. Each Party shall execute all necessary and proper documents and take such actions as shall be appropriate to allow the other Party to institute and prosecute such infringement actions. Each Party shall consult with and co-operate with the other Party in good faith in the event that either Party is pursuing any such action. Any award paid by third parties as a result of such an infringement action (whether by way of settlement or otherwise) shall be paid to the Party who instituted and maintained such action, or, if both Parties instituted and maintained such action, such award shall be allocated among the Parties in proportion to their respective contributions to the costs and expenses incurred in such action. Notwithstanding the foregoing, either Party may participate in any such suit or action and use its own counsel at its own expense for such purpose. Both Parties, and their respective counsel, shall cooperate by sharing information concerning any such suit or action. 8.3 Infringement Action by Third Parties. (a) In the event of the institution of any suit by a third party against ALTEON for patent or other intellectual property rights infringement or other use, rights or ownership claim involving the use or sale of any Product in the Territory (an "Action"), ALTEON shall promptly notify WASHINGTON in writing of such Action. In the event that such an Action is instituted by a third party, neither Party shall take a position inconsistent with, or cooperate with or assist any third party who contests, WASHINGTON's ownership or the continued validity of any Licensed Patent or Licensed Technology. Each Party shall use its best efforts to consult with, support and cooperate with the other Party, in good faith, in the event that either Party is pursuing any such Action, including specifically, without limiting the generality of the foregoing, actively and vigorously contesting any third party claim challenging WASHINGTON's right to grant the rights granted herein to ALTEON. ALTEON shall have the right to defend such suit at its own expense, and WASHINGTON hereby agrees to assist and cooperate with ALTEON, at its own expense, to the extent necessary in the defense of such suit; provided, however, that WASHINGTON shall not be obligated to engage in any testing at its own expense. During the pendency of such action, ALTEON shall continue to make all payments due under this Agreement. Notwithstanding the foregoing, either Party may participate in any such suit or action and use its own counsel at its own expense for such purpose. Both Parties, and their respective counsel, shall cooperate by sharing information concerning any such suit or action. -16- 22 Exhibit 10.10 (b) If as a result of any judgment, award, decree or settlement resulting from an Action instituted by a third party, ALTEON is required to pay a royalty to such third party, ALTEON shall continue to pay running royalties for such Products in the country which is the subject of such Action, but shall be entitled to a credit against such payments in an amount equal to one-half (1/2) of the royalty paid to such third party, but in no event shall such credit be more than 50% of such royalties due hereunder for such Products in such country which is the subject of such Action in any calendar semi-annual period. In addition, if ALTEON is required to pay damages to such third party, and such damages are not otherwise reimbursed by WASHINGTON, ALTEON shall be entitled to a credit against such payments in an amount equal to one-half (1/2) of such damages, to the extent effectively paid by ALTEON to such third party, but in no event shall the total credit provided hereunder be more than 50% of such royalties due hereunder for such Products in such country which is the subject of such Action in any calendar semi-annual period. ARTICLE 9 - PUBLICATION; CONFIDENTIALITY 9.1 Notification. ALTEON acknowledges that the basic objective of research activities at WASHINGTON is the generation of new knowledge and its expeditious dissemination. However, both Parties also recognize the importance of acquiring patent protection on inventions. Consequently, any proposed Publication by University Personnel shall comply with this ARTICLE 9. At least fifteen (15) days before a manuscript is to be submitted to a publisher, University Personnel will provide ALTEON with a copy of the manuscript. If University Personnel wish to make an oral presentation, they will provide ALTEON with a copy of the abstract (if one is submitted) at least fifteen (15) days before it is to be submitted. University Personnel will also provide to ALTEON a copy of the text of the presentation, including all slides, posters, and any other visual aids, at least fifteen (15) days before the presentation is made. 9.2 Review of Proposed Publications. ALTEON will review the manuscript, abstract, text or any other material provided under Section 9.1 to determine if patentable subject matter is disclosed. ALTEON will notify University Personnel within fifteen (15) days of receipt of the proposed Publication if ALTEON, in its sole discretion, determines that patentable subject matter is or may be disclosed, or if ALTEON, in its sole discretion, believes confidential or proprietary information is or may be disclosed. If it is determined by ALTEON that patent applications should be filed, the University Personnel shall delay its publication or presentation for a period not to exceed ninety (90) days from ALTEON's receipt of the proposed Publication to allow time for the filing of patent applications covering patentable subject matter. In the event that the delay needed to complete the filing of any necessary patent application will exceed the ninety (90) day period, WASHINGTON and University Personnel will discuss with ALTEON the need for obtaining an extension of the publication delay beyond the ninety (90) day period. The publication delay shall not exceed 105 days from the date that the proposed Publication was first submitted to ALTEON for review, except that, by mutual agreement, as provided in this Section, this delay may be extended past the 105 day period for purposes of filing patent applications. If it is determined by ALTEON and WASHINGTON that confidential or proprietary information is being disclosed, ALTEON, WASHINGTON and University Personnel will consult among themselves in good faith to arrive at an agreement on mutually acceptable modifications to the proposed Publication to avoid such disclosure. 9.3 Use of Name. WASHINGTON agrees not to use directly or indirectly ALTEON's name without ALTEON's prior written consent except that WASHINGTON may -17- 23 Exhibit 10.10 acknowledge ALTEON's funding of any Sponsored Research Programs in scientific publications and in listings of Sponsored Research Programs. ALTEON agrees not to use directly or indirectly WASHINGTON's name, the name of any Investigator or University Personnel, or the name of any trustee, officer, faculty member, student or employee thereof, without WASHINGTON's prior written consent, except that ALTEON may refer to any University Personnel who is serving as a member of ALTEON's Scientific Advisory Board or as a consultant to ALTEON and include a statement of his experience and qualifications and his current and past positions at WASHINGTON. Notwithstanding the foregoing, ALTEON and WASHINGTON may include an accurate description of the terms of this Agreement to the extent required under federal or state securities or other disclosure laws and internal communications; and ALTEON may use WASHINGTON's name in various documents used by ALTEON for capital raising and financing purposes, provided that WASHINGTON grants prior written approval of such use, which approval shall not be unreasonably withheld. WASHINGTON agrees that ALTEON's use of its name solely to identify this Agreement will be deemed a reasonable use by WASHINGTON for which it grants its approval. 9.4 Confidentiality; Exceptions. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing, the Parties agree that, for the term of this Agreement and for five years thereafter, the receiving Party shall keep completely confidential and shall not publish or otherwise disclose and shall not use for any purpose any information furnished to it by the other Party pursuant to this Agreement, except to the extent that it can be established by the receiving Party by competent proof that such information: (a) was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the other Party; (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party; (c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; (d) was disclosed to the receiving Party, other than under an obligation of confidentiality, by a third party who had no obligation to the disclosing Party not to disclose such information to others; or (e) was independently developed by or for the receiving Party by persons not having access to such information. Each Party may disclose the other's information to the extent such disclosure is reasonably necessary in filing or prosecuting patent applications, prosecuting or defending litigation, complying with applicable governmental regulations, undertaking basic research with outside collaborators, or conducting preclinical or clinical trials, provided that if a Party is required to make any such disclosure of the other Party's secret or confidential information it will, except where impracticable for necessary disclosures, for example to physicians conducting studies or to health authorities, give reasonable advance notice to the other Party of such disclosure requirement and, except to the extent inappropriate in the case of patent applications, will use its best efforts to secure confidential treatment of such information required to be disclosed. 9.5 Confidentiality Agreements with University Personnel. Prior to any University Personnel participating in any Sponsored Research Program or any ALTEON Research Program in any manner or receiving any test data, clinical -18- 24 Exhibit 10.10 information or any other information relating to or resulting from any Sponsored Research Program or any ALTEON Research Program which is deemed a trade secret or confidential or proprietary to ALTEON or WASHINGTON, WASHINGTON shall cause such University Personnel to execute a confidentiality and non-disclosure agreement with ALTEON in the form attached as Exhibit D. ARTICLE 10 - INDEMNIFICATION 10.1 Indemnification. ALTEON shall defend, indemnify and hold WASHINGTON, its directors, trustees, faculty members, officers and employees, harmless from and against any and all third party claims, suits or demands, threatened or filed, ("Claims") for liability, damages, losses, costs and expenses (including the costs and expenses of attorneys and other professionals), at both trial and appellate levels, relating to the distribution, testing, manufacture, use, sale, consumption, applications, or injection of Products by ALTEON, its Affiliates or its sublicensees pursuant to this Agreement, including, without limitation, Claims for any loss, damage, or injury to persons or property, or loss of life, or relating to the promotion and advertising of Products and/or interactions and communications with governmental authorities, physicians or other third parties. The foregoing indemnification shall not apply to any Claims to the extent caused by either the acts or omissions of WASHINGTON or any University Personnel. 10.2 Notice. In the event that WASHINGTON seeks indemnification under Section 10.1, WASHINGTON agrees to: (i) promptly inform ALTEON of any Claim, (ii) permit ALTEON to assume direction and control of the defense or claims resulting therefrom (including the right to settle it at the sole discretion of ALTEON), and (iii) cooperate as reasonably requested (at the expense of ALTEON) in the defense of the Claim. Notwithstanding the foregoing, WASHINGTON shall have the right to participate in the defense or prosecution of any Claim, including hiring its own counsel at its own expense, and ALTEON shall cooperate with WASHINGTON if WASHINGTON does so participate. 10.3 Insurance. ALTEON shall at all times comply with all statutory worker's compensation and employer's liability requirements covering any and all employees with respect to activities performed under this Agreement. In addition to the foregoing, ALTEON shall obtain and maintain the following: (a) Prior to the first human clinical trials of a Product under this Agreement, broad form comprehensive general liability insurance with a reputable and financially secure insurance carrier, to cover such activities of ALTEON and ALTEON's contractual indemnity under this Agreement. Such insurance shall provide minimum annual limits of liability of $2,000,000.00 per occurrence and in the aggregate with respect to all occurrences arising out of such human clinical trials of the Product. Such insurance policy shall apply to all occurrences arising our of such human clinical trials and shall be purchased and kept in force for the period of five (5) years after the cessation of sales of all Products under this Agreement. (b) In addition to the insurance provided in Section 10.3(a), prior to the first sale of Products under this Agreement, products liability insurance with a reputable and financially secure insurance carrier reasonably acceptable to WASHINGTON, to cover such activities of ALTEON and ALTEON's contractual indemnity under this Agreement. Such insurance shall provide minimum annual limits of liability of $2,000,000.00 per occurrence and $50,000,000.00 in the annual aggregate with respect to all occurrences being indemnified under this Agreement. Such insurance policy shall be purchased and kept in force for the -19- 25 Exhibit 10.10 period of five (5) years after the complete cessation of sales of all Products under this Agreement. (c) In the event that ALTEON chooses to rely on any strategic partners of ALTEON to satisfy any of the requirements for insurance under this Section 10.3, then ALTEON shall provide details of such coverage to WASHINGTON for its information. Any such coverage must substantially comply with the form, scope and amounts set forth in this Section 10.3 which are applicable to such insurance. In the event that any such insurance is a self-insured plan, ALTEON may choose to rely on same only if WASHINGTON reasonably determines in advance in writing that such strategic partner's self-insured plan is adequate given the financial condition of such strategic partner. WASHINGTON hereby agrees that any self-insured plan of Alteon's current strategic partners (i.e., Yamanouchi Pharmaceutical Co., Ltd., Marion Merrell Dow Inc. and Corange International Limited) is acceptable to WASHINGTON. At WASHINGTON's request, which shall not be more frequently than annually, ALTEON shall provide WASHINGTON with a certificate of such insurance or written verification by such strategic partner of such self-insurance. (d) At WASHINGTON's request, which shall not be more frequently than annually, ALTEON shall provide WASHINGTON evidence of insurance obtained pursuant to Section 10.3(a) or 10.3(b). In addition, ALTEON shall cause WASHINGTON to be added as an additional insured of any insurance obtained pursuant to Section 10.3(a) or 10.3(b). ALTEON shall not and shall not permit any strategic partner to, cancel or materially reduce the coverage of any policy of insurance required under this Section 10.3 without giving WASHINGTON thirty (30) days prior written notice thereof. (e) In the event that any insurance required under this Section 10.3 lapses, terminates or is cancelled, WASHINGTON may purchase on its own behalf such insurance as is necessary to remedy any short fall in coverage required to be provided under this Section 10.3. Any such insurance purchased by WASHINGTON shall be paid for by ALTEON. In addition, all insurance amounts provided for under this Section 10.3 shall be considered minimum amounts, and such minimum amounts shall be subject to an increase every five (5) years from the Effective Date of this Agreement, which increase shall be calculated in accordance with the compounded rise in the Consumer Price Index for the preceding five (5) years. In the event that any of the insurance required under this Section 10.3 is not available at commercially reasonable rates, the Parties agree to negotiate in good faith to modify such requirements and/or take such other actions as may be deemed reasonable and prudent to affect the purposes of this Agreement, including protection of WASHINGTON's interests hereunder. ARTICLE 11 - TERM; TERMINATION 11.1 Term. This Agreement shall commence as of the Effective Date of this Agreement and, unless sooner terminated as provided hereunder, shall terminate as follows: (a) As to the Sponsored Research Programs and collaboration between the parties as contemplated in ARTICLE 3, five (5) years from the Effective Date of this Agreement, unless extended by the mutual consent of the Parties. (b) As to each Product and as to each country in the Territory, this Agreement shall terminate upon the later of: (i) fifteen (15) years from the Effective Date of this Agreement; (ii) the expiration of the last to expire -20- 26 Exhibit 10.10 of the Licensed Patents necessary for the use and sale of such Product in such country; or (iii) ten (10) years after the first Commercial Sale of such Product in such country. (c) This Agreement shall terminate in its entirety upon its termination as to all Products. 11.2 Breach. Failure by either Party to comply with any of the material obligations contained in this Agreement shall entitle the other Party to give to the Party in default notice specifying the nature of the default and requiring it to cure such default. If such default is not cured within sixty (60) days after the receipt of such notice (or, if such default cannot be cured within such sixty (60) day period, if the Party in default does not commence and diligently continue actions to cure such default), the notifying Party shall be entitled, without prejudice to any of its other rights conferred on it by this Agreement, in addition to any other remedies available to it by law or in equity, to terminate this Agreement by giving written notice to take effect within thirty (30) days after such notice unless the defaulting Party shall cure such default within said thirty (30) days. The right of either Party to terminate this Agreement, as hereinabove provided, shall not be affected in any way by its waiver or failure to take action with respect to any previous default. 11.3 Termination by ALTEON. ALTEON shall have the right to terminate the licenses granted herein, in whole or as to any Product in any country in the Territory, at any time, and from time to time, by giving notice in writing to WASHINGTON. Such termination shall be effective thirty (30) days from the date such notice is given, and all ALTEON's rights associated therewith shall cease as of that date, subject to Section 11.5. 11.4 Termination of U.S. Rights. Termination of this Agreement by ALTEON as to the United States with respect to any Dosage Form shall give WASHINGTON the right to terminate this Agreement as to all countries for such Dosage Form. Upon such termination by WASHINGTON, WASHINGTON shall be free to grant rights, including sub-licenses, to third parties for the making, using and selling of said Dosage Form throughout the world with no claim by ALTEON. 11.5 Right to Sell Stock on Hand. Upon the termination of any license granted herein, in or whole or as to any Product, for any reason other than a failure to cure a material breach of the Agreement by ALTEON, ALTEON shall have the right for one year or such longer period as the Parties may reasonably agree to dispose of all Product or substantially completed Product then on hand to which such termination applies, and royalties shall be paid to WASHINGTON with respect to such Product as though this Agreement had not terminated. 11.6 Termination of Sublicenses. Upon any termination of this Agreement, all sublicenses granted by ALTEON under this Agreement shall terminate simultaneously, subject, nevertheless, to Section 11.5. 11.7 Effect of Termination. (a) Upon the termination of any license granted herein as to any Product in any country in the Territory other than pursuant to Section 11.1, ALTEON and its sublicensees shall promptly: (i) return to WASHINGTON all relevant records, materials or confidential information concerning the Licensed Technology relating to such Product in such country in the possession or control of ALTEON or any of its sublicensees; (ii) assign to WASHINGTON, or WASHINGTON's designee, its registrations with governmental health authorities, licenses, and approvals of such Product in such country; and (iii) assign to WASHINGTON, or WASHINGTON's -21- 27 Exhibit 10.10 designee, its right to any trade name or trademark used by ALTEON or any sublicensee for such Product in such country. (b) Following expiration of the term of this Agreement, in whole or in part, pursuant to Section 11.1, ALTEON shall have the royalty-free non-exclusive right within the Field to continue to use and sell the Products, including the right to grant sublicenses therefor, as heretofore licensed in Section 4.1. 11.8 Surviving Rights. Termination of this Agreement shall not terminate ALTEON's obligation to pay all royalties which shall have accrued hereunder. The Parties' obligations under ARTICLES 6, 8, 9 and 10 and Sections 11.7, 12.12 and 12.13 shall survive termination. 11.9 Accrued Rights, Surviving Obligations. Termination, relinquishment or expiration of this Agreement for any reason shall be without prejudice to any rights which shall have accrued to the benefit of either Party prior to such termination, relinquishment or expiration. Such termination, relinquishment or expiration shall not relieve either Party from obligations which are expressly indicated to survive termination or expiration of this Agreement. ARTICLE 12 - MISCELLANEOUS PROVISIONS 12.1 Relationship of Parties. Nothing in this Agreement is intended or shall be deemed to constitute a partnership, agency, employer-employee or joint venture relationship between the Parties. No Party shall incur any debts or make any commitments for the other, except to the extent, if at all, specifically provided herein. 12.2 Assignment. Except as otherwise provided herein, neither this Agreement nor any interest hereunder shall be assignable by any Party without the prior written consent of the other; provided, however, that either Party may assign this Agreement to any wholly-owned subsidiary or to any successor by merger or sale of substantially all of its assets to which this Agreement relates in a manner such that the assignor shall remain liable and responsible for the performance and observance of all its duties and obligations hereunder. This Agreement shall be binding upon the successors and permitted assigns of the parties and the name of a Party appearing herein shall be deemed to include the names of such Party's successor's and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any assignment not in accordance with this Section 12.2 shall be void. 12.3 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement. 12.4 Force Majeure. Neither Party shall be liable to the other for loss or damages or shall have any right to terminate this Agreement for any default or delay attributable to any act of God, flood, fire, explosion, strike, lockout, labor dispute, shortage of raw materials, casualty or accident, war, revolution, civil commotion, act of public enemies, blockage or embargo, injunction, law, order, proclamation, regulation, ordinance, demand or requirement of any government or subdivision, authority or representative of any such government, or any other cause beyond the reasonable control of such Party, if the Party affected shall give prompt notice of any such cause to the other -22- 28 Exhibit 10.10 Party. The Party giving such notice shall thereupon be excused from such of its obligations hereunder as it is thereby disabled from performing for so long as it is so disabled and for thirty (30) days thereafter. Notwithstanding the foregoing, nothing in this Section 12.4 shall excuse or suspend the obligation to make any payment due hereunder in the manner and at the time provided. 12.5 No Trademark Rights. Except as otherwise provided herein, no right, express or implied, is granted by this Agreement to use in any manner the name "ALTEON" or "WASHINGTON UNIVERSITY" or any other trade name or trademark of the other party in connection with the performance of this Agreement. 12.6 Public Announcements. Except as required by law, neither Party shall make any public announcement concerning this Agreement or the subject matter hereof without the prior written consent of the other. In the event of a required public announcement, the Party making such announcement shall provide the other with a copy of the proposed text prior to such announcement. 12.7 Notices. All notices and other communications hereunder shall be in writing and shall be deemed given if delivered personally or by facsimile transmission (receipt verified), telexed, mailed by registered or certified mail (return receipt requested), postage prepaid, or sent by express courier service, to the parties at the following addresses (or at such other address for a party as shall be specified by like notice; provided, that notices of a change or address shall be effective only upon receipt thereof): (a) If to ALTEON, addressed to: Alteon Inc. 170 Williams Drive Ramsey, New Jersey 07446-2907 Attention: Chief Executive Officer Telephone No.: (201) 934-5000 Facsimile No.: (201) 934-8880 (b) If to WASHINGTON, addressed to: Washington University Technology Management Office School of Medicine Box 8013 724 South Euclid Avenue St. Louis, MO 63110 Attention: Director, Technology Management Telephone No.: (314) 747-0922 Facsimile No.: (314) 362-5872 12.8 Amendment. No amendment, modification or supplement of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party. 12.9 Waiver. No provision of this Agreement shall be waived by any act, omission or knowledge of a Party or its agents or employees except by an instrument in writing expressly waiving such provision and signed by the waiving Party. 12.10 Counterparts. This Agreement may be executed simultaneously in two counterparts, either one of which need not contain the signature of more than one party but both such counterparts taken together shall constitute one and the same agreement. -23- 29 Exhibit 10.10 12.11 Descriptive Headings. The descriptive headings of this Agreement are for convenience only, and shall be of no force or effect in construing or interpreting any of the provisions of this Agreement. 12.12 Governing Law. This Agreement shall be governed by and interpreted in accordance with the laws of the State of New Jersey, applicable to contracts executed and performed wholly within the State of New Jersey. 12.13 Arbitration. (a) All disputes which cannot be resolved arising between ALTEON and WASHINGTON under this Agreement shall be settled by arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration Association. Such arbitration shall be conducted by three (3) arbitrators appointed according to said rules. The Parties will cooperate with each other in causing the arbitration to be held in as efficient and expeditious a manner as practicable. (b) Any award rendered by the arbitrators shall be final and binding upon the Parties. Judgment upon the award may be entered in any court of record of competent jurisdiction. Each Party shall pay its own expenses of arbitration and the expenses of the arbitrators shall be equally shared unless the arbitrators assess as part of their award all or any part of the arbitration expenses of one Party (including reasonable attorneys' fees) against the other Party. 12.14 Severability. Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be prohibited by or invalid under applicable law, such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement. 12.15 Compliance with Law. Nothing in this Agreement shall be deemed to permit a Party to export, reexport or otherwise transfer any Licensed Technology or Licensed Patents transferred hereunder or Products manufactured therefrom without compliance with applicable laws. 12.16 Entire Agreement of the Parties. This Agreement constitutes and contains the entire understanding and agreement of the Parties and cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether oral or written, between the Parties respecting the subject matter hereof. -24- 30 Exhibit 10.10 IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed by its duly authorized officer as of the day and year first above written. THIS AGREEMENT IS SUBJECT TO BINDING ARBITRATION. WASHINGTON UNIVERSITY Date: June 2, 1995 By: /s/ E.J. Brandt, Ph.D. ------------ ------------------------- Name: E.J. Brandt, Ph.D. --------------------- Title: Director, Technology --------------------- Management --------------------- ALTEON INC. Date: June 2, 1995 By: /s/ James J. Mauzey ------------ ------------------------- Name: James J. Mauzey --------------------- Title: Chairman and Chief --------------------- Executive Officer --------------------- -25- 31 Exhibit 10.10 The undersigned is an Investigator (as defined in this Agreement) and is executing this Agreement to acknowledge his or her agreement to comply with the provisions of Articles 3, 7 and 9 of this Agreement which are applicable to Investigators and/or University Personnel (as defined in this Agreement). Signature: /s/ J.R. Williamson ------------------- Print Name: J.R. Williamson ------------------- Date: June 2, 1995 ------------------------ -26- 32 Exhibit 10.10 The undersigned is an Investigator (as defined in this Agreement) and is executing this Agreement to acknowledge his or her agreement to comply with the provisions of Articles 3, 7 and 9 of this Agreement which are applicable to Investigators and/or University Personnel (as defined in this Agreement). Signature: /s/ M.L. McDaniel ----------------- Print Name: M.L. McDaniel ----------------- Date: June 2, 1995 ----------------------- -27- 33 Exhibit 10.10 The undersigned is an Investigator (as defined in this Agreement) and is executing this Agreement to acknowledge his or her agreement to comply with the provisions of Articles 3, 7 and 9 of this Agreement which are applicable to Investigators and/or University Personnel (as defined in this Agreement). Signature: /s/ J.A. Corbett ---------------- Print Name: J.A. Corbett ---------------- Date: June 2, 1995 --------------------- -28- 34 Exhibit 10.10 EXHIBIT A U.S. AND FOREIGN PATENTS AND PATENT APPLICATIONS RELATING TO THE LICENSED TECHNOLOGY U.S. Patent #5,246,970, issued September 21, 1993 relating to a method of treating immunologically-mediated, nitric oxide-mediated diseases by aminoguanidine. U.S. Patent #5,358,969, issued October 25, 1994, relating to the treatment of acute inflammatory diseases, which is not immunologically-mediated, by use of aminoguanidine. Continuation-in-part application to U.S. Patent #[c.i.], filed [c.i.] PCT Application #[c.i.] -29- 35 Exhibit 10.10 EXHIBIT B RESEARCH PROJECTS INVOLVING THE LICENSED TECHNOLOGY To be agreed upon by the parties. -30- 36 Exhibit 10.10 EXHIBIT C LIST OF COUNTRIES WHERE PATENTS WILL BE FILED AND MAINTAINED [C.I.] -31- 37 Exhibit 10.10 EXHIBIT D FORM OF CONFIDENTIALITY AND NON-DISCLOSURE AGREEMENT -32- 38 Exhibit 10.10 CONFIDENTIALITY AGREEMENT AGREEMENT ("Agreement") effective as of ______________ between the undersigned (the "Recipient") and Alteon Inc. (the "Company"). The Recipient and the Company are referred to collectively as the "Parties" hereinafter. WHEREAS, the Parties possesses certain valuable and/or Confidential Information relating to their business interests; and WHEREAS, the Recipient will participate on behalf of Washington University in certain collaborative research programs (the"Sponsored Research") with the Company pursuant to a Sponsored Research Program as described in that certain Research Collaboration and License Agreement between the Company and Washington University dated as of June 2, 1995; and WHEREAS, each party is willing to disclose to the other Party upon the terms and conditions hereinafter set forth, Confidential Information in order that meaningful collaborative research may take place; NOW, THEREFORE, in consideration of the foregoing premises that are incorporated as part of this Agreement and the mutual covenants hereinafter set forth, the Parties agree as follows: 1. Definition of Confidential Information. All information disclosed by either Party to the other Party in oral, written, graphic, photograhic, recorded, prototype, sample or in any other form shall be considered "Confidential Information" if so marked; provided, however, that any oral communication shall not be considered Confidential Information hereunder unless it is reduced to writing within 60 days. 2. Disclosure of Confidential Information. Each Party may disclose to the other Party Confidential Information as part of the research collaboration for the Sponsored Research to enable the Parties to engage in meaningful research collaboration. The Parties agree to accept and hold such Confidential Information in accordance with the provisions of this Agreement. -33- 39 Exhibit 10.10 3. Disclosure to Third Parties. From and after the date of this Agreement, each Party agrees neither to disclose to any third party nor permit any third party to have access to any or all of the Confidential Information disclosed to such Party, except for other participants in the Sponsored Research who have agreed with the Company to keep such information in confidence, without the prior written consent of the disclosing Party, nor to use any of the Confidential Information for any purpose other than the conduct of the Sponsored Research or as otherwise consented to in wiring by the Parties. However, the aforesaid obligations shall not apply CONFIDENTIALITY AGREEMENT Page 2 to information which the Party can clearly demonstrate falls within any one of the following categories: (i) Information that is now generally known to the public through no fault of the Party. (ii) Information that, as of the time of disclosure to the Party was Already known to and in the possession of the Party, as evidenced by written records; or (iii) Information obtained after the date of this Agreement hereof from a third party lawfully in possession of and with no limitation upon disclosure of that information, and having the right to disclose the same. 4. Return of Confidential Information. At any time, either Party may request the return of all confidential Information and all copies thereof, received from or on behalf of the other Party, and each Party agrees to promptly comply with such requests. Each Party agrees that, subsequent to a request for return of Confidential Information or notification of termination of the collaboration the provisions of this Agreement shall continue with respect to all Confidential Information until any items 3 (i) - (iii) become applicable. 5. Use of Confidential Information. The Parties shall not use the Confidential Information for any purpose except for purposes of the Sponsored Research. -34- 40 Exhibit 10.10 6. Governing Laws. This Agreement shall be governed and construed in accordance with all applicable laws of the State of New Jersey. 7. Limitation of Agreement. This Agreement shall in no way be construed as the granting of a license to either Party by the other directly or indirectly under any patent or patent application owned by the disclosing Party. Furthermore, nothing in this Agreement shall be interpreted so as to oblige either Party to enter into a further agreement. 8. Term. The obligations of the Parties under this agreement shall continue for the duration of the Parties participation in the Sponsored Research and for a period of five (5) years thereafter. 9. Amendments. This Agreement cannot be altered or otherwise amended except pursuant to an instrument in writing signed by each of the Parties hereto. 10. Disclosure of this Agreement. The Parties are hereby authorized to notify others, including but not limited to customers of the Company and any of Recipients's current and future employers, CONFIDENTIALITY AGREEMENT Page 3 of the terms of this Agreement and the Parties' responsibilities hereunder. 11. Injunctive Relief and Enforcement. The Parties understand that in the event of a breach or threatened breach of this Agreement the Recipient or the Company, as the case may be, may suffer irreparable harm and will therefore be entitled to injunctive relief to enforce this Agreement. The Parties also agree that if any court shall determine that any provision of this Agreement is unenforceable with respect to its term or scope then such provision shall nonetheless be enforceable by any such court upon such modified term or scope as may be determined by such court to be reasonable and enforceable. Alteon Inc. Recipient Signed : ______________________________ Signed : ______________________________ Name : ________________________________ Name : ________________________________ -35- 41 Exhibit 10.10 Title : ________________________________ Title : ______________________________ Date : _________________________________ Date : _______________________________ -36-
EX-10.11 8 w46067ex10-11.txt DISTRIBUTION AGREEMENT DATED SEPTEMBER 25, 1995 1 Exhibit 10.11 ALTEON Alteon Inc. 170 William Drive - Ramsey, NJ 07446 (201) 934-5000- Fax (201) 934-8880 DISTRIBUTION AGREEMENT THIS AGREEMENT is made this 25th day of September, 1995 by and between ALTEON INC. of 170 Williams Drive, Ramsey, New Jersey 07446, USA (hereinafter called "Alteon") of the one part and ERYPHILE BV of Marten Meesweg 51, 3068 AV Rotterdam, the Netherlands (hereinafter called "Eryphile") of the other part WHEREAS : (A) Alteon has developed and is the owner of the proprietary rights to the Product (as hereinafter defined), and (B) Alteon and Eryphile desire to enter into an agreement pursuant to which Eryphile will have the sole and exclusive right to market, distribute and sell such Product in the Territory (as hereinafter defined) NOW, THEREFORE, in consideration of the mutual covenants herein contained and for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, THE PARTIES HERETO AGREE as follows : Grant and Acceptance of Rights 1.01 Alteon, subject to the terms and conditions of this Agreement, hereby grants to Eryphile the sole and exclusive right to purchase the Product for re-sale in the Territory (as such terms "Product" and "Territory" are defined in Section 2), and Eryphile accepts such appointment. Said appointment shall mean that Alteon shall not appoint any third party for the promotion, distribution or sale of the Product (whether under Alteon's own or any other trademarks) in the Territory, and shall not itself distribute or sell the same in or to the Territory. Alteon shall refer to Eryphile all contacts for the sale of and any enquiries relating to the Product in the Territory. 1.02 Eryphile shall be an independent contractor under this Agreement. Except as otherwise provided in this Agreement or expressly agreed between the parties hereafter in writing, Eryphile is not authorised to: (i) enter into agreements for or on behalf of Alteon; (ii) create any obligation or liability, express or implied, for or on behalf of Alteon; (iii) accept settlement of any debt or other obligation due or owed to Alteon; (iv) accept service of process for Alteon; or (v) bind Alteon in any manner or thing whatsoever; and Eryphile shall not list, print or display Alteon's name in such manner as to indicate or imply that there is an employer-employee or principal-agent relationship between Alteon and Eryphile. Distribution Agreement Page 2 2 Exhibit 10.11 Distribution Agreement Page 2 1.03 Subject to its material compliance with all applicable laws and regulations and except as otherwise provided in this Agreement, Eryphile shall have full control over the manner and means of performing its obligations hereunder. All expenses incurred by Eryphile in connection with the performance of such obligations, including the appointment and remuneration of employees, agents or representatives, shall be the sole responsibility of Eryphile. 2. Product and Territory 2.01 The Product is described in Exhibit A hereto, and includes any and all ancillary products relating thereto and any and all modifications, improvements, developments or replacements of or appertaining to such Product except that the Product shall in all events be therapeutic dosage forms only in finished product form only. The parties from time to time by mutual agreement in writing may add to such Exhibit any other existing or future product of Alteon. 2.02 The "Territory" shall consist of the countries specified in Exhibit B hereto and such other countries (if any) as the parties from time to time to time may add to such Exhibit by mutual agreement in writing. 2.03 Eryphile is not acquiring any rights to the Product outside the Territory. Accordingly, Eryphile shall not sell any Product to anyone outside the Territory, and shall not sell any Product to anyone in the Territory who either Eryphile or Alteon has reasonable grounds to believe might resell it outside the Territory or might permit any Product obtained by it to be transported outside the Territory. 2.04 Alteon is and will at all times be the owner of all rights to the Product, including registrations with governmental authorities in the Territory, except for the distribution rights granted pursuant to this Agreement. 3. Promotion and Sale of Product During the term of this Agreement: 3.01 Eryphile shall use its best efforts in the registration and related clinical testing, promotion, distribution and sale of the Product in the Territory. Such efforts in Israel and South Africa shall not be less than the efforts which it devotes to new products of comparable commercial promise in countries with comparable market opportunities. 3.02 Eryphile shall organize and maintain a competent promotional and selling organization for the Product in the Territory, and hold an inventory of the Product sufficient to meet market demand therefor in the Territory without undue delay. 3 Exhibit 10.11 Distribution Agreement Page 3 3.03 Alteon shall provide Eryphile with reasonable quantities of such English-language promotional and advertising material as it from time to time shall have available on the Product. On the basis of such material, Eryphile shall be responsible for the preparation of such local-language promotional and advertising material as may be required, such material to be subject to the reasonable prior approval of Alteon. Alteon shall also provide Eryphile with such quantities of samples of the Products as from time to time shall be reasonably agreed between the parties. 3.04 Eryphile shall refer to Alteon all enquiries for the Product from outside the Territory. 3.05 Alteon undertakes to provide Eryphile as and when appropriate with scientific, technical and clinical advice and information in relation to the Product, and to respond promptly and constructively to enquiries or recommendations made from time to time by Eryphile, whether on its own initiative or at the request of opinion leaders or other interested parties in the Territory, concerning the use of the Product or possible improvements or modifications thereof. 3.06 Eryphile shall comply with all health registration laws, regulations and orders of any government authority within the Territory and with all other governmental requirements applicable to its sales activities with respect to the Product. Alteon shall furnish Eryphile with such assistance and cooperation as may reasonably be requested in connection with compliance with such governmental requirements, including without limitation the file of clinical and other data and such samples of the Product or its active ingredients as may be required for registration purposes. Eryphile shall also use its best efforts to obtain, at its own expense, any import license, foreign exchange permit, or other permit or approval it may need for the performance of its duties under this Agreement. In particular and whenever appropriate, Eryphile will proceed expeditiously to take all such steps as shall be reasonably necessary to obtain regulatory approval for each and every new application or therapeutic dosage form of the Product, including the conduct, at Eryphile's expense, of further clinical trials or similar procedures within the Territory to the extent (if any) required in each case. All registrations, licences, permits and other government approvals and filings relating to the Product shall specify that Alteon is the owner of the Product and of the registrations and all other rights to the Product except for the distribution rights granted pursuant to this Agreement. 3.07 The Product shall be packaged and labelled for distribution and sale in the Territory in accordance with local law in a manner to be mutually agreed between the parties. Eryphile shall be entitled to have included on such packaging and labelling an indication that it is the territorial source of the Product. 4 Exhibit 10.11 Distribution Agreement Page 4 3.08 Eryphile undertakes not, without the prior written consent of Alteon, to promote and sell in the Territory any product which is used for the same therapeutic purpose as the Product. 4. Planning & Minimum Standards 4.01 Prior to 30th September of each year during the continuance of this Agreement, Eryphile will submit to Alteon a plan for the marketing, distribution and sale of the Product in the Territory during the next calendar year (hereinafter referred to as "the Plan"), the first such Plan to be annexed to this Agreement. 4.02 The Plan will include, on a country by country basis, Eryphile's forecasted sales and marketing programme for the relevant year in respect of each therapeutic dosage form of the Product and will propose for such year in relation to Israel and South Africa respectively: 4.2.1 a minimum purchase quota (hereinafter referred to as the "Minimum Quota"), and 4.2.2 a minimum program of marketing efforts (hereinafter referred to as the "Minimum Program"). 4.03 The Minimum Quotas and Minimum Programs for the said countries for each calendar year will be finally established by mutual agreement between the parties prior to the first day of the relevant year, failing which an expert shall be appointed to resolve the open issues outstanding between the parties, such expert to be named by mutual agreement of the parties or, failing which and at the request of either party, by the Secretary-General of the International Chamber of Commerce. 4.04 It is agreed with respect to Minimum Quotas that 4.4.1 they shall not exceed seventy per cent (70%) of reasonable full purchase forecasts for the countries respectively concerned for each relevant year; 4.4.2 in the fixing of Minimum Quotas in accordance herewith, reasonable regard shall be taken of the sales of the Product by Alteon or Alteon licensees in other comparable markets, according to the guidelines included in Exhibit B hereto. 4.05 In the event that, in any calendar year, Eryphile shall fail in either Israel or South Africa to meet both the applicable Minimum Quota and Minimum Program, Alteon shall be entitled within ninety (90) days of the end of such year to serve a written 5 Exhibit 10.11 Distribution Agreement Page 5 notice upon Eryphile, removing the country in question from the Territory with effect 120 days from the date of such notice, provided however that if Eryphile places orders with Alteon for Product within such 120 days, for delivery within 90 days, in quantities equal to or greater than the shortfall from the Minimum Quota during the prior calendar year plus any shortfall from the pro rata portion of the Minimum Quota for the current calendar year, such notice shall not take effect and that country shall remain within the Territory. 4.06 In the event that Eryphile is no longer distributing the Product in either Israel or South Africa, its distribution rights for Bulgaria, Cyprus and Jordan shall be terminated and this Agreement shall be terminated. 5. Prices and Terms of Sale 5.01 The price from Alteon to Eryphile for the Product will be established by Alteon, in reasonable consultation with Eryphile, once the Product is approved for sale in Israel. Alteon may change said price from time to time upon giving Eryphile written notice of the change at least ninety (90) days in advance of the effective date thereof. The new price will apply to all orders accepted by Alteon after said effective date, and also to orders accepted by Alteon prior to such date in the case of any quantities of the Product ordered for shipment more than ninety (90) days after that date. Alteon agrees, notwithstanding the foregoing, that the prices charged by it to Eryphile shall not exceed Alteon's lowest prices to other distributors for similar quantities. 5.02 Alteon will use reasonable commercial efforts to meet each order for the Product placed by Eryphile on or before the requested shipment date, provided such date is at least sixty (60) days from the date on which Alteon receives the order. Orders from Eryphile shall be deemed accepted by Alteon unless rejected in writing within fourteen (14) days of receipt of order. Alteon reserves the right to specify a different reasonable shipment date by written notice to Eryphile given within such fourteen (14) days' period, failing which the shipment date requested by Eryphile shall be deemed accepted. Shipments shall be made pursuant to Eryphile's instructions; all deliveries shall be properly packed for overseas shipment. It is understood that Eryphile may use its normal purchase order form with respect to its purchases of the Product, which form may specify (inter alia) the quantity of the Product ordered, the method of shipment, the requested shipment date(s), and the destination to which shipment is to be made. Such form shall be used for convenience only, however, and any terms or conditions on such form which are inconsistent with the terms and conditions of this Agreement shall have no force or effect whatsoever as between the parties, regardless of whether Alteon might otherwise be deemed to have accepted such form by reason of its acknowledgement or execution thereof. 6 Exhibit 10.11 Distribution Agreement Page 6 5.03 All payments due to Alteon from Eryphile for the Product hereunder shall be payable in US Dollars within ninety (90) days of date of invoice to such bank account as Alteon from time to time may designate. The terms of sale shall be FOB Alteon's warehouse. Eryphile agrees to pay and to hold Alteon harmless from all import duties, sales, use, excise or other taxes, and all costs of transportation, brokerage, handling and insurance, applicable to the delivery of the Product hereunder from point of shipment. 5.04 During the term of this Agreement, if Eryphile so requests, Alteon will give reasonable consideration to modification of this Agreement to provide for the supply of Product in bulk form for repackaging in final dosage form by Eryphile, provided Alteon deems such arrangement to be in the best interests of both parties under terms and conditions acceptable to Alteon. 6. Term of Agreement and Termination 6.01 Subject to earlier termination as provided for in this Section 6, this Agreement shall be for an initial period commencing on the date hereof and ending on the last day of the tenth (10th) year following the date upon which regulatory approval is issued for the sale of the Product in Israel. Thereafter, this Agreement shall automatically continue for further consecutive periods of three (3) years each, unless and until it is terminated on the last day of said initial period or of any such further period by one party serving upon the other party not less than one hundred and twenty (120) days' prior written notice to such effect. 6.02 In the event of a material default by either party in the performance of any of its obligations under this Agreement, the other party shall have the right to give written notice to the defaulting party advising such party of the default involved. If the defaulting party shall not have remedied such default within ninety (90) days (or, in the case of the breach of a financial obligation, 30 days) after receipt of such notice, the other party shall have the right, in addition to any other rights or remedies it may have, to terminate this Agreement immediately upon giving a further written notice to the defaulting party. 6.03 Either party may immediately terminate this Agreement at any time by giving written notice of such termination in the event that the other party is adjudged insolvent or institutes or permits to be instituted against it (without a dismissal thereof within 90 days) any proceedings in consequence of debt under any applicable law. 6.04 Upon the effective date of termination of this Agreement for whatever reason, the right of Eryphile to promote, distribute and sell the Product in the Territory shall cease. Thereupon, Alteon shall re-purchase Eryphile's outstanding stock of the 7 Exhibit 10.11 Distribution Agreement Page 7 Product in saleable condition at a price equivalent to Eryphile's landed cost therefor, FOB Eryphile's warehouse, provided, that Alteon shall not be required to purchase more than 50% of the amount of Product sold by Eryphile in the previous 12 months, and further provided that Alteon shall have no obligation to re-purchase any Product if the termination of this Agreement is on account of a breach of contract by Eryphile. 6.05 Alteon shall continue to meet Eryphile's orders for the Product placed prior to the effective date of termination hereof, but no termination of this Agreement shall in any manner whatsoever release, or be construed as releasing, either party from any liability to the other arising out of or in connection with such party's breach of or failure to perform any covenant, undertaking or obligation contained in this Agreement. 7. Warranties Alteon warrants that the Product will be manufactured in accordance with generally accepted good manufacturing practices in the pharmaceutical industry, will meet its specifications and will be free from defects in materials or workmanship. Alteon shall promptly replace any Product found to be defective without charge or expense to Eryphile. Any such defective Product shall, at Alteon's election and cost, be either returned to Alteon or destroyed. Alteon makes no other warranty of any kind and excludes and disclaims, to the extent permitted by applicable law, any and all implied warranties, including (without limitation) those concerning the merchantability of the Product or its suitability for any particular purpose or use. Alteon excludes, in particular, any liability for indirect or consequential damages. Should Eryphile make any warranty or representation inconsistent with or in addition to the warranties of Alteon stated in this Section 7, Eryphile shall at its own expense defend and hold harmless Alteon from any claim to the extent it is based upon such inconsistent or additional warranty or representation. 8. Trademarks and Trade Names 8.01 Eryphile recognizes the validity of Alteon's trademarks and trade names as set forth in Exhibit C hereto and such other trademarks and trade names as Alteon may designate for the Product, acknowledges that the same are the property of Alteon, and agrees not to infringe upon, harm or contest the rights of Alteon to its trademarks and trade names. 8 Exhibit 10.11 Distribution Agreement Page 8 8.02 Eryphile shall not use any of Alteon's trademarks or trade names, except in conformity with this Agreement or as otherwise approved in writing by Alteon. Eryphile shall not use Alteon's trademarks or trade names in connection with any products other than the Product, but shall have the right during the continuance hereof to use the same in connection with the Product. 8.03 Eryphile agrees that upon termination of this Agreement for any reason it will destroy or, at Alteon's option, return to Alteon any advertising, promotional or other materials bearing any of Alteon's trademarks or trade names. 8.04 Alteon shall take prompt action at its expense to stop all infringements in the Territory of its trademarks and trade names (including court actions, if necessary) whenever it determines such to be commercially reasonable. If Alteon decides that it would not be commercially reasonable to take such action, Eryphile may do so, at its expense, in the names of both Alteon and Eryphile. 9. Intellectual Property Claims Alteon will defend, indemnify and hold harmless Eryphile against any and all third party claims of patent, trademark or other intellectual property infringement which may be asserted against Eryphile because of its marketing, advertising or sale of the Product in the Territory (except for claims of infringement of a trade name or trademark other than one covered by this Agreement). In such event, Alteon will bear all losses, damages, costs and expenses suffered or incurred by Eryphile in connection with any such claim and the defense thereof, or as a result of any settlement made or judgement rendered on the basis of such claim. Alteon shall have sole and exclusive control of the defense of any such claim and shall have the right to settle or compromise any claims on terms acceptable to Alteon. Notwithstanding the provisions of Section 6 of this Agreement, Alteon shall have right, upon notice to Eryphile, to withdraw the affected dosage form or forms of the Product from sale for any country for which such claim is made and to amend this Agreement accordingly. 10. Product Liability Claims Alteon shall defend, indemnify and hold harmless Eryphile against any and all product liability claims arising out of the use of the Product, except to the extent that such claims arise out of or relate to mishandling (including improper storage), modification or misuse of the Product, product claims which were not expressly approved by Alteon, or other negligence or wrongful action or inaction by Eryphile, its employees or agents. Eryphile shall give Alteon prompt notice of every complaint, claim or suit known to Eryphile concerning the Product, keep Alteon fully informed of the status of each, and afford Alteon reasonable access to its 9 Exhibit 10.11 Distribution Agreement Page 9 records pertaining to such complaint, claim or suit. Alteon shall have the right to defend and control the defense of, or to settle, any such claim. Eryphile shall have the right, at its own expense, to participate in any such defense action or settlement negotiations. Eryphile shall likewise defend, indemnify and hold harmless Alteon as to any product liability claims arising out of the use of the Product in the Territory to the extent that such claims arise out of or relate to mishandling (including improper storage), modification or misuse of the Product, product claims which were not expressly approved by Alteon, or other negligence or wrongful action or inaction by Eryphile, its employees or agents. 11. Confidential Information Each party agrees that it will treat in the strictest confidence all oral and written communications from the other party which are designated, or which should reasonably be regarded in a normal commercial view, as constituting business secrets or proprietary information (hereinafter referred to as "Proprietary Information"). Each party agrees to refrain from disclosing or making available to any third party and to refrain from using for any purpose other than the implementation of the Agreements between the parties any of the other party's Proprietary Information without such other party's prior written consent. Each party also agrees to reveal Proprietary Information only to those persons who have a need to know it in connection with the implementation of such Agreements and who are required to keep it confidential, and to impose upon its respective affiliates, employees and agents the same obligations with respect to said other party's Proprietary Information as it employs with respect to its own confidential information. The provisions of this Section shall survive the termination of this Agreement. Proprietary Information hereunder shall not, however, include information (i) which is in or enters the public domain through no breach of this Agreement, or (ii) which is known to the party receiving the same at the time of disclosure, as evidenced by such party's prior written records, or (iii) which such party may receive from a third party lawfully entitled to disclose the same. 10 Exhibit 10.11 Distribution Agreement Page 10 12. Miscellaneous Provisions 12.01 Rights Cumulative Each and all of the respective rights and remedies of the parties hereunder shall be considered to be cumulative with and in addition to any other rights or remedies which such parties may have at law or in equity in the event of the breach of any of the terms of this Agreement. The exercise or partial exercise of any right, power or remedy shall neither constitute the exclusive election thereof, nor the waiver of any other right or remedy available to either party. 12.02 Notices Any notice or other formal communication which either party may wish or be required to serve on the other party in connection with this Agreement shall be in writing and may be delivered by personal service or sent by registered or certified air mail, return receipt requested, with postage fully prepaid, provided that a copy of every such notice sent by mail shall be simultaneously transmitted by telefax. Notices shall be addressed as follows: If to Alteon: ALTEON Inc. 170 Williams Drive Ramsey, NJ 07446 USA Telefax No: 1 - 201 - 934 0090 If to Eryphile: ERYPHILE BV P.O.Box 2295 3000 CG Rotterdam The Netherlands Telefax No: 31 - 20 - 661 0654 Either party may from time to time, by notice in writing served upon the other as provided above, designate a change of address for the service of notices. Nothing contained in this Agreement shall excuse either party from giving oral notice to the other when prompt notification is appropriate, but such notice shall not satisfy the requirement of written notice as specified in this Section. 11 Exhibit 10.11 Distribution Agreement Page 11 12.03 Severability If any provision of this Agreement is held to be void or unenforceable by or as a result of the decision of any court or other authority, which decision is binding upon the parties, the parties agree that such decision shall not result in the nullity or unenforceability of the remaining provisions of this Agreement. The parties further agree to use their mutual best efforts to replace such void or unenforceable provision in a manner which will achieve, to the extent possible, the economic, business and other purposes of said void or unenforceable provision. 12.04 Force Majeure No failure to observe any of the terms or conditions of this Agreement shall be deemed to be a breach of this Agreement, if the same is caused by or arises out of one or more of the following conditions, namely: acts of God; acts, regulations or laws of any government or similar authority; war; civil commotion; destruction of facilities or materials by fire, earthquake or storm; labor disturbances; epidemics; failure of public utilities or of suppliers; or any other event, matter or thing wheresoever occurring and whether or not of the same class or kind as those set forth above, which is not reasonably within the control of the affected party. However, the parties shall endeavor to avoid or cure all such conditions, and any party temporarily excused from performance by such conditions shall resume performance promptly when such conditions are removed. Any party claiming any such conditions as an excuse for delay in performance shall give prompt notice in writing of such conditions to the other party. The parties, furthermore, while any such conditions shall prevail, will cooperate by reasonable mutual agreement to minimize the effects of such conditions by adopting any suitable temporary measures which may be available to them. 12.05 Choice of Law The internal laws of the State of New Jersey, without reference to any principles concerning conflicts of law, shall govern the validity of this Agreement, the construction of its terms and the interpretation of the rights and duties of the parties hereunder. 12.06 Arbitration Any dispute or claim in any way arising out of or relating to this Agreement shall be finally settled by arbitration under the Rules of Conciliation and Arbitration of the International Chamber of Commerce. In the event that the request for arbitration shall be submitted by Alteon, the arbitration shall be held in Tel-Aviv, Israel, and in the event that such request shall be made by Eryphile, the arbitration shall take 12 Exhibit 10.11 Distribution Agreement Page 12 place in New Jersey, USA. The language to be used in the proceedings shall be English, and each party shall bear one half of the costs of the arbitration. The decision of the arbitrator(s) shall be definitive, binding and without appeal, and judgement upon the award rendered may be entered in any court of competent jurisdiction. 12.07 Interpretation (i) The headings used at the beginnings of the Sections and certain sub-sections of this Agreement are for convenience only and form no part hereof. They are not to serve as a basis for interpretation or construction of this Agreement, nor as evidence of the intention of the parties. (ii) References in this Agreement to the plural shall where the context so admits include the singular, and vice versa. 12.08 Counterparts This Agreement may be executed in separate counterparts, each of which shall be deemed an original and, when executed separately or together, shall constitute a single original instrument, effective in the same manner as if the parties had executed one and the same instrument. 12.09 Waiver No waiver of any term or condition of this Agreement, whether by conduct or otherwise, in any one or more instances shall be deemed to be, or construed as a further or continuing waiver of any such term or condition, or as a waiver of any other term or condition of this Agreement. 12.10 Entire Agreement This Agreement and the Clinical Testing Agreement between the parties of even date herewith are intended by the parties to be the final expression of their agreement as to the subject matter herein and therein, and constitute the entire understanding between them with respect thereto. They are a complete and exclusive statement of the terms and conditions of such understanding, and shall supersede any and all prior correspondence, conversations, negotiations, understandings or agreements relating to the same subject matter. 13 Exhibit 10.11 Distribution Agreement Page 13 12.11 Amendments No change in, modification of or addition to the terms conditions contained in this Agreement shall be valid unless set forth in a written document signed by both parties, which specifically states that it constitutes an amendment hereto. 12.12 Assignment Neither party to this Agreement shall assign or otherwise transfer any of its rights or obligations hereunder to any third party without the prior written approval of the other party, except that (a) Alteon may assign any or all of its rights and obligations hereunder to an Affiliate (as hereinafter defined), and (b) Eryphile may delegate or assign any or all of its rights and obligations hereunder to an Affiliate (as hereinafter defined) resident in the Territory, provided that (c) The Affiliate agrees in writing with the parties that it will be bound by all of the terms of the Agreement which impose obligations upon its assignor, and (d) The assigning party will remain fully responsible for the performance of the Affiliate to which it assigns its rights. "Affiliate" for the purposes hereof means a company controlling, controlled by or under common control with the party concerned, "control" meaning the holding of more than fifty per cent (50%) of the common voting stock or voting equity share capital of the relevant company. Eryphile, moreover, shall be entitled to engage sub-distributors in connection with its performance hereunder, but only upon terms and conditions which are consistent in all respects with those of this Agreement. Furthermore, Alteon may assign all of its rights and obligations hereunder without approval to any party to whom Alteon sells its related business assets. 12.13 Successors and Assigns This agreement and all of its terms and conditions are intended to be fully effective and binding, to the extent permitted by applicable law, upon the successors and permitted assigns of the parties (including, in the case of Alteon, any successor in title to assets of Alteon which include rights in relation to the Product). 14 Exhibit 10.11 Distribution Agreement Page 14 12.14 Exhibits All exhibits referred to in and attached to this Agreement are intended to be a part of this Agreement as if set forth in full in the text hereof. IN WITNESS WHEREOF, this Agreement has been signed by the duly authorized signatories of the parties hereto the day and year first before written, ALTEON INC. ERYPHILE BV by: /s/ James J. Mauzey by: ------------------- --------------------------- James J. Mauzey Director Title: Chairman and Chief Executive Officer --------------------------- Director 15 Exhibit 10.11 Distribution Agreement Page 15 EXHIBIT A Product PIMAGEDINE all dosage forms for therapeutic uses (including all existing and future indications therefor) EXHIBIT B Territory Israel (including Israeli-administered territories and the areas of Palestinian autonomy and any future political denominations of such territories and areas) Bulgaria Cyprus Jordan South Africa NOTE: Guidelines for the fixing of Minimum Quotas (a) in respect of Israel, the comparable market to be taken into account is Italy, and (b) in respect of South Africa (to the extent of that proportion of its population enjoying a standard of living equivalent to that prevailing in Western Europe), such comparable market is the United Kingdom, on a per capita basis in each case. 16 Exhibit 10.11 Distribution Agreement Page 16 EXHIBIT C Trademarks & Trade Names ALTEON PIMAGEDINE trademark for Pimagedine to be determined EX-10.12 9 w46067ex10-12.txt EMPLOYMENT AGREEMENT DATED AS OF OCTOBER 21, 2000 1 Exhibit 10.12 EMPLOYMENT AGREEMENT THIS EMPLOYMENT AGREEMENT (this "Agreement"), dated as of October 21, 2000, by and between Alteon Inc., a Delaware corporation (the "Company"), and Elizabeth A. O'Dell (the "Employee"). WHEREAS, the Company wishes to employ the Employee as Vice President, Finance and Administration; and WHEREAS, the Employee wishes to enter into the employ of the Company as its Vice President; Finance and Administration; Treasurer and Secretary; NOW, THEREFORE, in consideration of the premises and the mutual covenants contained herein, the parties hereby agree as follows; 1. Term of Employment. Subject to the terms and conditions hereof, the Company will employ the Employee, and the Employee will serve the Company, as Vice President, Finance and Administration, for a period beginning on the date hereof and terminating December 31, 2003, subject to extension by mutual agreement of the Company and the Employee (such term, as it may be extended, is hereinafter referred to as the "Term of Employment"). 2. Duties. During the Term of Employment, the Employee will serve as Vice President, Finance and Administration, subject to the terms of this Agreement and the direction and control of the Board of Directors, and/or the Chief Executive Officer of the Company. The Employee will, during the Term of Employment, serve the Company faithfully, diligently and competently and to the best of Employee's ability, and will, consistent with the dignity of Vice President, Finance and Administration of the Company, hold, in addition to the offices of Vice President, Finance and Administration of the Company, such other offices in the Company to which Employee may be appointed or assigned from time to time by the Board of Directors and/or the Chief Executive Officer of the Company and will discharge such duties in connection therewith. The Employee shall devote all business time to the performance of the duties hereunder. 3. Compensation. During the Term of Employment, the Company will pay to the Employee as compensation for the performance of Employee's duties and obligations hereunder a base salary at the rate of $145,000 per annum until December 31, 2000 and at the rate of $150,800 per annum for the calendar year 2001 ("Salary"), payable in equal semi-monthly installments. For periods after calendar year 2001, such Salary shall be reviewed annually by the Board of Directors of the Company in accordance with the Company's compensation program. In each of the Company's fiscal years during the Term of Employment, the Employee shall be eligible to receive a cash bonus of up to $5,000, to be awarded at the sole discretion of the Board of Directors of the Company. The Board shall use as a basis for determining the extent of such bonus awards the attainment of stated goals and objectives for the Employee to be set by the Compensation Committee of the Board after consultation with the Chief Executive Officer. 4. Other Benefits. During the Term of Employment: A. The Employee shall be entitled during the Term of Employment to participate in employee benefit plans and programs of the Company to the extent that Employee's position, tenure, salary, age, health and other qualifications make Employee eligible to participate. 2 Exhibit 10.12 Employment Agreement Page 2 The Company does not guarantee the adoption or continuance of any particular employee benefit plan or program during the Term of Employment, and the Employee's participation in any such plan or program shall be subject to the provisions, rules, regulations and laws applicable thereto; provided, however, that during the Term of Employment, the Employee shall be entitled to health and hospital insurance benefits consistent with the past practices of the Company in effect with respect to Company personnel generally; and, further provided, the Employee is eligible for protection under the Alteon Inc. Change in Control Severance Benefits Plan, as in effect from time to time. B. The Employee shall be entitled to five weeks vacation per year while employed hereunder. Such vacation may be taken by the Employee at such times as do not unreasonably interfere with the business of the Company. The accumulation of annual vacation time earned, but not taken, will be in accordance with the Company policy guidelines. Additional vacation will be earned in accordance with Company policy. 5. Expenses. During the Term of Employment, the Company will reimburse the Employee for all travel and other reasonable business expenses incident to the rendering of services by the Employee under this Agreement, subject to the submission of appropriate vouchers and receipts in accordance with the Company's policy from time to time in effect. 6. Death or Disability. A. This Agreement shall be terminated by the death of the Employee. In addition, this Agreement may be terminated by the Board of Directors of the Company if the Employee shall be rendered incapable by illness or any other disability, from complying with the terms, conditions and provisions on Employee's part to be kept, observed and performed for a period in excess of 180 days (whether or not consecutive) or 90 days consecutively, as the case may be, during a 12-month period during the Term of Employment ("Disability"). If this Agreement is terminated by reason of Disability of the Employee, the Company shall give written notice to that effect to the Employee in the manner provided herein. In the event that the Employee receives disability insurance benefits paid for by the Company during any period prior to termination of this Agreement pursuant to this Section 6(a), the Employee's Salary shall be reduced by an amount equal to such disability insurance benefits during such period. B. In addition to and not in substitution for any other benefits which may be payable by the Company with respect to the death or Disability of the Employee in the event of such death or Disability, the Salary payable hereunder shall continue to be paid at the then current rate for three months after the termination of employment, and any bonus to which the Employee would have been entitled for the year in which Employee's death occurs shall be pro rated to the date of Employee's death and paid not later than three months after the termination of employment. In the event of the death of the Employee during the Term of this Agreement, the sums payable hereunder shall be paid to Employee's personal representative. 7. Disclosure of Information, Inventions and Discoveries. The Employee shall promptly disclose to the Company all processes, trademarks, inventions, improvements discoveries and other information related to the business of the Company (collectively, "Developments") conceived, developed or acquired by Employee alone or with others during the Term of Employment or during any earlier period of employment by the Company or any predecessor of the Company, whether or not during regular working hours or through the use of materials or facilities of the Company. All such Developments shall be the sole and exclusive property of 3 Exhibit 10.12 Employment Agreement Page 3 the Company, and, upon request, the Employee shall promptly deliver to the Company all drawings, sketches, models and other data and records relating to such Developments. In the event any such Development shall be deemed by the Company to be patentable, the Employee shall, at the expense of the Company, assist the Company in obtaining a patent or patents thereon and execute all documents and do all such other acts and things necessary or proper to obtain letters of patents and to invest in the Company full right, title and interest in and to such Developments. 8. Non-Disclosure. The Employee shall not, at any time during or after the Term of Employment, divulge, furnish or make accessible to anyone (otherwise than in the regular course of business of the Company), or use for Employee's own account or for the account of any person, any knowledge or information with respect to confidential or secret processes, inventions, discoveries, improvements, formulae, plans, materials, devices or ideas or other know-how, whether patentable or not, with respect to any confidential or secret development or research work or with respect to any other confidential or secret aspects of the Company's business (including, without limitation, customer lists, supplier lists and pricing arrangements with customers or suppliers). 9. Non-Competition. The Company and the Employee agree that the services rendered by the Employee hereunder are unique and irreplaceable. The Employee hereby agrees that, during the Term of Employment and for a period of one year thereafter, the Employee shall not (i) in any geographical area in the United States or in those foreign countries where the Company, during the Term of Employment, conducts or proposes to conduct business or initiates activities, engage or participate in, directly or indirectly (whether as an officer, director, employee, partner, consultant, holder of an equity or debt investment, lender or in any other manner or capacity), or lend Employee's name (or any part or variant thereof) to any business which is, or as a result of the Employee's engagement or participation would become, competitive with any aspect of the business of the Company, such business being the commercialization of the measurement, prevention therapy or reversal of glucose-mediated non-enzymatic crosslinking of macro-molecules, and such other specific technologies in which the Company has, during the Term of Employment, initiated significant plans to develop products, (ii) deal, directly or indirectly, in a competitive manner with any customers doing business with the Company during the Term of Employment (except in connection with the performance of the duties and obligations of the Employee during the Term of Employment), (iii) solicit any officer, director, employee, consultant or agent of the Company to become an officer, director, employee, consultant or agent of the Employee, Employee's respective affiliates or anyone else, and (iv) engage in or participate in, directly or indirectly, any business conducted under any name that shall be the same as or similar to the name of the Company or any trade name used by it. Ownership, in the aggregate, of less than one percent of the outstanding shares of capital stock of any corporation with one or more classes of its capital stock listed on a national securities exchange or publicly traded in the over-the-counter market shall not constitute a violation of the foregoing provision. 10. Remedies. The Employee acknowledges that irreparable damage would result to the Company if the provisions of Section 7, 8, 9 or 14 were not specifically enforced, and agrees that the Company shall be entitled to any appropriate legal, equitable or other remedy, including injunctive relief, in respect to any failure to comply with the provisions of Section 7, 8, 9 or 14. 11. Termination for Cause. In addition to any other remedy available to the Company, either at law or in equity, the Employee's employment with the Company may be terminated by the 4 Exhibit 10.12 Employment Agreement Page 4 Board of Directors for cause, which shall include (i) the Employee's conviction for, or plea of nolo contendere, to a felony or a crime involving moral turpitude, (ii) the Employee's commission of an act of personal dishonesty or a breach of fiduciary duty involving personal profit in connection with the Employee's employment by the Company, (iii) the Employee's commission of an act which the Board of Directors shall reasonably have found to have involved willful misconduct or gross negligence on the part of the Employee in the conduct of Employee's duties under this Agreement, (iv) habitual absenteeism, (v) the Employee's material breach of any material provision of this Agreement, or (vii) the willful and continued failure by the Employee to perform substantially Employee's duties with the Company (other than any such failure resulting from Employee's incapacity due to physical or mental illness). In the event of termination under this Section 11, the Company's obligations under this Agreement shall cease and the Employee shall forfeit all rights to receive any future compensation under this Agreement. Notwithstanding any termination of this Agreement pursuant to this Section 11, the Employee, in consideration of Employee's employment hereunder to the date of such termination, shall remain bound by the provisions of Section 7, 8, 9 and 14 hereof. 12. Termination Without Cause. Each of the Company and Employee may terminate this Agreement at any time for any reasons whatsoever, without any further liability or obligation of the Company to the Employee or of the Employee to the Company from and after the date of such termination (other than liabilities or obligations accrued but unsatisfied on, or surviving, the date of such termination), by sending 30 days' prior written notice to the other party. In the event (a) the Company elects to terminate this Agreement prior to the end of the Term of Employment, or (b) the Company gives Employee notice of its election not to extend the Term of Employment beyond the expiration of the then current Term of Employment, or (c) by the date which is four months prior to the end of the then current Term of Employment, the Company has not offered to extend the then current Term of Employment, the Company shall continue to pay the Employee the full Salary (exclusive of bonuses, if any) as such Salary would have otherwise accrued for a period of six months if the effective date of such termination occurs prior to the first anniversary of this Agreement, and for a period of six months if the effective date of such termination occurs thereafter. In the event the Employee elects to terminate prior to the end of the Term of Employment, the Company's obligation to pay Salary shall cease as of the effective date of termination. Notwithstanding any termination of this Agreement pursuant to this Section 12, the Employee, in consideration of Employee's employment hereunder to the date of such termination, shall remain bound by the provisions of Section 7, 8, 9 and 14 hereof. Any termination of this Agreement by the Company as provided in this Section 12 shall be in addition to, and not in substitution for, any rights with respect to termination of the Employee which the Company may have pursuant to Section 11. 13. Resignation. In the event that the Employee's services under this Agreement are terminated under any of the provisions of this Agreement (except by death), the Employee agrees to deliver written resignation from all positions held with the Company to the Board of Directors, such resignation to become effective immediately; provided, however, that nothing herein shall be deemed to affect the provisions of Section 7, 8, 9 and 14 hereof relating to the survival thereof following termination of the Employee's services hereunder, and provided, further, that except as expressly provided in this Agreement, the Employee shall be entitled to no further compensation hereunder. 14. Data. Upon termination of the Term of Employment or termination pursuant to Sections 6, 11 or 12 hereof, the Employee or Employee's personal representative shall promptly deliver to 5 Exhibit 10.12 Employment Agreement Page 5 the Company all books, memoranda, plans, records and written data of every kind relating to the business and affairs of the Company which are then in Employee's possession. 15. Insurance. The Company shall have the right, at its own cost and expense, to apply for and to secure in its own name or otherwise, life, health or accident insurance or any or all of them covering the Employee, and the Employee agrees to submit to usual and customary medical examinations and otherwise to cooperate with the Company in connection with the procurement of any such insurance, and any claims thereunder. 16. Waiver of Breach. Any waiver of any breach of this Agreement shall not be construed to be a continuing waiver or consent to any subsequent breach on the part either of the Employee or of the Company. 17. Assignment. This Agreement shall inure to the benefit of and be binding upon the successors and assigns of the Company upon any sale of all or substantially all of the Company's assets, or upon any merger or consolidation of the Company with or into any other entity, all as though such successors and assigns of the Company and their respective successors and assigns were the Company. Insofar as the Employee is concerned, this Agreement, being personal, may not be assigned. 18. Severability. To the extent any provision of this Agreement shall be invalid or unenforceable, it shall be considered deleted therefrom and the remainder of such provision and of this Agreement shall be unaffected and shall continue in full force and effect. In furtherance and not in limitation of the foregoing, should the duration or geographical extent of, or business activities covered by, any provision of this Agreement be in excess of that which is valid and enforceable under applicable law, then such provision shall be construed to cover only that duration, extent or activities which may be validly and enforceable covered. 19. Notices. All notices, requests and other communications pursuant to this Agreement shall be in writing and shall be deemed to have been duly given, if delivered in person or by courier, telegraphed, telexed or by facsimile transmission or five business days after being sent by registered or certified mail, return receipt requested, postage paid, addressed as follows: If to the Employee: Elizabeth A. O'Dell 53 Avon Drive Essex Fells, New Jersey 07021 If to the Company: Alteon Inc. 170 Williams Drive Ramsey, New Jersey 07446 with a copy to: Richard J. Pinto, Esq. Smith, Stratton, Wise, Heher & Brennan 600 College Road East Princeton, New Jersey 08540 6 Exhibit 10.12 Employment Agreement Page 6 Any party may, by written notice to the other in accordance with this Section 19, change the address to which notices to such party are to be delivered or mailed. 20. General. Except as otherwise provided herein, the terms and provisions of this Agreement and any Stock Option Grant Agreements entered into between the Employee and the Company shall constitute the entire agreement by the Company and the Employee with respect to the subject matter hereof, and shall supersede any and all prior agreements or understandings between the Employee and the Company, whether written or oral. This Agreement may be amended or modified only by a written instrument executed by the Employee and the Company. This Agreement may be executed in any number of counterparts, all of which, when executed, shall be deemed to be an original, and all of which together shall constitute one and the same instrument. IN WITNESS WHEREOF, the parties have executed this Employment Agreement as of the day and year first above written. ALTEON INC. By: /s/ Kenneth I. Moch -------------------------------------- Kenneth I. Moch President and Chief Executive Officer /s/ Elizabeth A. O'Dell ------------------------------------- Elizabeth A. O'Dell EX-10.13 10 w46067ex10-13.txt ALTEON INC. CHANGE IN CONTROL SEVERENCE BENEFITS 1 Exhibit 10.13 ALTEON INC. CHANGE IN CONTROL SEVERANCE BENEFITS PLAN Effective February 27, 1996 2 Exhibit 10.13 TABLE OF CONTENTS INTRODUCTION................................................................ 1 ARTICLE I DEFINITIONS................................................................. 1 ARTICLE II ENTITLEMENT TO BENEFITS..................................................... 5 2.1 ELIGIBILITY REQUIREMENTS.................................. 5 2.2 LIMITATION ON ENTITLEMENT TO BENEFITS..................... 5 ARTICLE III SEVERANCE BENEFITS UNDER THE PLAN........................................... 5 3.1 AVAILABLE SEVERANCE BENEFITS.............................. 5 3.2 CONTINUATION OF BENEFITS UPON DEATH....................... 6 3.3 LIMITATION OF SEVERANCE BENEFITS.......................... 7 ARTICLE IV AMENDMENT OR TERMINATION OF PLAN............................................ 7 ARTICLE V MISCELLANEOUS............................................................... 7 5.1 PLAN INTERPRETATION....................................... 7 5.2 GENDER AND NUMBER......................................... 7 5.3 UNFUNDED OBLIGATIONS...................................... 8 5.4 TRANSFERABILITY OF BENEFITS............................... 8 5.5 NO GUARANTEE OF TAX CONSEQUENCES.......................... 8 5.6 CONSTRUCTION, GOVERNING LAWS.............................. 8 5.7 SEPARABILITY.............................................. 8 5.8 EMPLOYEE'S RIGHTS......................................... 9 5.9 ACTION BY THE COMPANY..................................... 9 ARTICLE VI ERISA PROVISIONS............................................................ 9 6.1 CLAIM FOR BENEFITS........................................ 9 6.2 NAMED FIDUCIARY........................................... 10 6.3 GENERAL FIDUCIARY RESPONSIBILITIES........................ 10
i 3 Exhibit 10.13 ALTEON INC. CHANGE IN CONTROL SEVERANCE BENEFITS PLAN INTRODUCTION Alteon Inc. ("Company") has adopted the Alteon Inc. Change in Control Severance Benefits Plan ("Plan") effective February 27, 1996 to reward its Employees for loyal service to the Company by providing for Severance Benefits to Employees upon certain terminations of employment after a Change in Control of the Company. The Board of Directors of the Company ("Board"), has determined that the establishment of the Plan is in the best interest of the Company and its shareholders to protect and retain qualified Employees and to encourage their full attention and dedication to the Company, free from distractions caused by personal uncertainties and risks related to a pending or threatened Change in Control of the Company. ARTICLE I DEFINITIONS 1.1 "Acquiring Person" means any "Person" or group of "Affiliates" or "Associates" (as those terms are defined in Rule 12b-2 of the general rules and regulations under the Securities Exchange Act of 1934, as amended) who is or becomes the beneficial owner, directly or indirectly, of 20% or more of the outstanding Stock. 1.2 "Administrator" means the Committee or the individual or individuals appointed by the Committee to carry out the administration of the Plan. In the event the Administrator has not been appointed or resigns from a prior appointment, the Company shall be deemed to be the Administrator. Any procedure, discretionary act, interpretation or construction taken by the Administrator shall be done in a nondiscriminatory manner based upon uniform principles consistently applied and shall be consistent with the intent and terms of the Plan. All determinations by the Administrator shall be final and binding upon Employees and all other parties having an interest in this Plan. 1.3 "Base Amount" shall be an Employee's "base amount" as defined and determined under Section 280G of the Code and applicable Regulations at the time of an Employee's Qualifying Termination. 1.4 "Base Compensation" means one-twelfth of an Employee's gross salary (including any amounts deferred under any Company plan or program), for the Compensation Period which includes his or her Qualifying Termination (or Change in Control if an Employee's Base Amount is higher during such Compensation Period). 1.5 "Board" means the Board of Directors of the Company. 1.6 "Change in Control" means: (a) the Company is merged with or into or consolidated with another corporation or other entity under circumstances where the shareholders of the Company immediately prior to such merger or consolidation do not own, after such merger or consolidation, shares representing at least fifty percent (50%) of the 1 4 Exhibit 10.13 voting power of the Company or the surviving or resulting corporation or other entity, as the case may be; or (b) the Company is liquidated or sells or otherwise disposes of substantially all of its assets to another corporation or entity; or (c) any person (as such term is used in Sections 13(d) and 14(d)(2) of the Securities Exchange Act of 1934) shall become the beneficial owner (within the meaning of Rule 13d-3 under such Act) of forty percent (40%) or more of the Common Stock of the Company other than pursuant to a plan or arrangement entered into by such person and the Company or otherwise approved by the Board; or (d) during any period of two (2) consecutive years, individuals who at the beginning of such period constitute the entire Board of Directors shall cease for any reason to constitute a majority of the Board unless the election or nomination for election by the Company's shareholders of each new director was approved by a vote of at least two-thirds of the directors then still in office who were directors at the beginning of the period. 1.7 "Code" means the Internal Revenue Code of 1986, as amended. 1.8 "Committee" means the Compensation Committee of the Board or any successor to the Committee or any other committee appointed by the Board to perform the functions of the Committee hereunder. 1.9 "Company" means Alteon Inc. and any successor thereto. 1.10 "Compensation Period" means the twelve month period for which an Employee's annual compensation and benefits are determined by the Company. 1.11 "Continuing Director" means any member of the Board who is not an Acquiring Person and who was a member of the Board prior to the time when the Acquiring Person became an Acquiring Person. "Continuing Director" includes any successor of a Continuing Director, while the successor is a member of the Board, who is not an Acquiring Person or a representative or nominee of an Acquiring Person and who is recommended or elected to succeed the Continuing Director by a majority of the Continuing Directors. 1.12 "Employee" means any individual who is employed by and regularly performs personal services for the Company. 1.13 "Employment Group A" means the group of Employees that includes (a) officers of the Company who serve in a position of authority equal to or greater than that possessed by a vice president of the Company, and (b) departmental directors. 1.14 "Employment Group B" means the group of Employees that includes associates of the Company. 1.15 "ERISA" means the Employee Retirement Income Security Act of 1974, as amended. 1.16 "Plan" means the Alteon Inc. Change in Control Severance Benefits Plan, as stated herein and as amended from time to time. 1.17 "Qualifying Termination" means, within two years after a Change in Control, termination of employment other than Termination for Cause, as defined 2 5 Exhibit 10.13 in Section 1.21, or resignation by an Employee within 90 days after a detrimental change in the nature or scope of his or her employment or duties. Detrimental change shall include, without limitation, the assignment of the Employee to any duties substantially inconsistent with his or her then current position, duties, responsibilities or status with the Company or a substantial reduction in such duties or responsibilities, the removal of the Employee from, or any failure to re-elect him or her to his or her then current positions, a reduction in base salary or other employee benefits, the failure by the Company to continue to provide the Employee with substantially similar bonus opportunities, the relocation of the Employee's primary office of employment to a location more than thirty-five (35) miles from the location of such office prior to the relocation, and substantially increased travel requirements. Notwithstanding anything herein to the contrary, if an Employee's employment with the Company is terminated prior to the date on which a Change in Control occurs, and if such Employee reasonably demonstrates that his or her termination of employment (a) was at the request of a third party who had taken steps reasonably calculated to effect such Change in Control or (b) otherwise arose in connection with or anticipation of such Change in Control, then, provided such Change in Control occurs, for all purposes of this Plan, such Employee will have incurred a "Qualifying Termination" on the date immediately prior to the date of such termination of employment. Notwithstanding the foregoing, "Qualifying Termination" shall not include any termination prior to a Change in Control which is undertaken by the Company in the ordinary course of its business or in response to an adverse change in its business, financial condition or results of operations. 1.18 "Regulations" means the Income Tax Regulations as promulgated by the Secretary of the Treasury or his or her delegate, as amended from time to time. 1.19 "Severance Benefits" means benefits provided under the Plan pursuant to Article III. 1.20 "Stock" means the Company's Common Stock. 1.21 "Termination for Cause" means: (a) as to any Employee for whom there is then in effect an employment agreement with the Company, the Employee's termination for cause or as a result of death or disability, in each case as defined in and permitted by such employment agreement; and (b) as to any Employee for whom there is not then in effect an employment agreement with the Company, the Employee's termination of employment with the Company due to the Employee's: (i) conviction for, or plea of nolo contendere to, a felony or a crime involving moral turpitude; (ii) commission of an act of personal dishonesty or breach of fiduciary duty involving personal profit in connection with the Employee's employment by the Company; (iii) commission of an act which the Administrator shall reasonably, in its sole discretion, have found to have involved willful misconduct or gross negligence on the part of the Employee, in the conduct of his or her duties; 3 6 Exhibit 10.13 (iv) habitual absenteeism; (v) material breach of any material provision of any agreement between the Employee; (vi) willful and continued failure to perform substantially his or her duties with the Company (other than any such failure resulting from his or her incapacity due to physical or mental illness); or (vii) death or disability. 4 7 Exhibit 10.13 ARTICLE II ENTITLEMENT TO BENEFITS 2.1 ELIGIBILITY REQUIREMENTS Each Employee is eligible for benefits upon a Qualifying Termination, subject to Section 2.2 below. Benefits under this Plan shall be in addition to, and not in substitution for, benefits, including, without limitation, severance benefits and bonus payments, to which an Employee is entitled pursuant to any agreement or understanding between the Company and the Employee. 2.2 LIMITATION ON ENTITLEMENT TO BENEFITS Notwithstanding any other provision of this Plan, no Employee shall be entitled to receive benefits under this Plan upon a Qualifying Termination if, prior to the Change in Control, a majority of the Continuing Directors who are then members of the Board of Directors of the Company approve, and do not rescind, a resolution providing that no benefits shall be paid to terminated Employees upon the occurrence of the Change in Control. ARTICLE III SEVERANCE BENEFITS UNDER THE PLAN 3.1 AVAILABLE SEVERANCE BENEFITS Each Employee who has incurred a Qualifying Termination shall be entitled to the following Severance Benefits, based on his or her status as a member of Employment Group A or Employment Group B: (a) Employment Group A. If an Employee who has incurred a Qualifying Termination is a member of Employment Group A, the Employee shall receive: (1) continuation of his or her Base Compensation payable each month for the twenty-four months following his or her date of Qualifying Termination (or the Change in Control, if later), or, at the election of the Employee, a lump sum payment equal to the present value as of the date of Qualifying Termination (or the Change in Control, if later) of such payments discounted at the rate prescribed under Section 1.280G-1 Q & A-24(c)(2) of the Regulations; (2) continuation of participation in all benefit programs and plans providing for health or life insurance in which the Employee participated and upon the same terms available either immediately prior to the Change in Control or the date of Qualifying Termination (whichever would provide the Employee with greater benefits) until the earlier of (a) eighteen (18) months after his or her date of Qualifying Termination (or the Change of Control, if later) or (b) as to any benefit program or plan, the date on which he or she is first eligible to receive from another source a benefit program or plan substantially similar to and no less favorable than the benefit program or plan provided by the Company. If the terms of any benefit plan do not permit continued participation by the Employee, then the Company will pay to the Employee each month during the period provided in the preceding sentence the amounts set forth in the following sentences. With respect to health insurance the Company will pay the Employee an amount equal to the full monthly premium paid by it for the coverage in effect for the Employee and his or her dependents on the Employee's date of Qualifying Termination or the Change in Control (whichever would provide the Employee with greater benefits). With respect to life insurance the Company will pay the Employee an amount equal to the monthly premium on any life insurance policy 5 8 Exhibit 10.13 obtained by the Employee which provides benefits substantially similar to the life insurance provided to the Employee under the Company's benefit plans on his or her date of Qualifying Termination or the Change in Control (whichever would provide the Employee with greater benefits) up to a maximum of one and one-half (1-1/2) times the monthly cost to the Company of providing life insurance to the Employee on his or date of Qualifying Termination or Change in Control, as the case may be. (b) Employment Group B. If an Employee who has incurred a Qualifying Termination is a member of Employment Group B, the Employee shall receive continuation of his or her Base Compensation payable each month for two months, plus one additional month for each year of service (up to a maximum payment period of 24 months), following his or her date of Qualifying Termination (or the Change in Control, if later), or, at the election of the Employee, a lump sum payment equal to the present value as of the date of Qualifying Termination (or the Change in Control, if later) of such payments discounted at the rate prescribed under Section 1.280G-1 Q & A-24(c)(2) of the Regulations. 3.2 CONTINUATION OF BENEFITS UPON DEATH Upon the death of an Employee who has incurred a Qualifying Termination, the continuation of his or her Base Compensation determined in accordance with Section 3.1(a)(1) or 3.1(b) of this Plan shall be paid to the beneficiary designated by the Employee under this Plan. If no beneficiary is designated, such payments shall be made to his or her surviving spouse, if any, or to his or her estate. In addition, the survivors of a deceased Employee from Employment Group A who had incurred a Qualifying Termination shall have such rights to other benefits as would be available to the survivors of a deceased Employee in Employment Group A who had not incurred a Qualifying Termination. 6 9 Exhibit 10.13 3.3 LIMITATION OF SEVERANCE BENEFITS In the event that the present value of any Severance Benefits, as set forth in this Plan, combined with any other benefits which constitute "parachute payments" within the meaning of Section 280G of the Code would be subject to the excise tax imposed by Section 4999 of the Code ("Excise Tax"), then the amount of Severance Benefits may be reduced to the amount which the Employee, in his or her sole discretion, determines would result in no portion of such benefits (or only such portion thereof as is acceptable to the Employee) being subject to the Excise Tax. The determination by the Employee of any reduction shall be conclusive and binding upon the Company. The Company shall reduce such Severance Benefits only upon written notice, received from the Employee not later than thirty days after the date on which he or she becomes eligible for benefits, indicating the amount of such reduction. ARTICLE IV AMENDMENT OR TERMINATION OF PLAN The Committee or the Board may at any time amend or terminate this Plan, provided that at the time of such amendment or termination Continuing Directors comprise a majority of the Committee or the Board, as the case may be, and a majority of the Continuing Directors then serving on the Committee or the Board, as the case may be, approve such amendment or termination. Notwithstanding anything to the contrary contained herein, the Plan may not be amended in any respect or terminated after the occurrence of a Change in Control. ARTICLE V MISCELLANEOUS 5.1 PLAN INTERPRETATION All provisions of this Plan shall be interpreted and applied in a uniform, nondiscriminatory manner. This Plan shall be read in its entirety and not severed except as provided in Section 5.6. 5.2 GENDER AND NUMBER Wherever any words are used herein in the masculine, feminine or neuter gender, they shall be construed as though they were also used in another gender in all cases where they would so apply, and whenever any words are used herein in the singular or plural form, they shall be construed as though they were also used in the other form in all cases where they would so apply. 7 10 Exhibit 10.13 5.3 UNFUNDED OBLIGATIONS All benefits due an Employee or an Employee's beneficiary under this Plan are unfunded and unsecured and are payable out of the general funds of the Company. The Company, in its sole and absolute discretion, may establish a "grantor trust" for the payment to one or more Employees of any or all benefits and obligations under this Plan, the assets of which shall be at all times subject to the claims of creditors of the Company as provided for in the trust, provided that the trust does not alter the characterization of the Plan as an "unfunded plan" for purposes of the ERISA. The trust shall make distributions in accordance with the terms of the Plan. The Company may, in its discretion, set aside the necessary funds to satisfy and discharge the Company's obligations under this Plan. Any funds remaining after the satisfaction and discharge of all obligations under this Plan shall be returned to the Company, its successors or assigns. 5.4 TRANSFERABILITY OF BENEFITS The right to receive payment of any benefits under this Plan shall not be transferred, assigned or pledged except by beneficiary designation or by will or under the laws of descent and distribution. 5.5 NO GUARANTEE OF TAX CONSEQUENCES Neither the Administrator nor the Company makes any commitment or guarantee regarding tax consequences to an Employee under any federal, state, or local income tax laws, resulting from the receipt of any Severance Benefits provided under this Plan (or other benefits which are contingent upon a Change in Control). Any Employee who may be subject to Excise Tax may reduce his or her Severance Benefits as provided in Section 3.2. Each Employee acknowledges that all amounts payable hereunder shall be reduced by any and all federal, state and local taxes, including applicable Excise Taxes, imposed upon the Employee or his or her beneficiary which are required to be paid or withheld by the Company. 5.6 CONSTRUCTION, GOVERNING LAWS Except to the extent that federal legislation or applicable regulation shall govern, the validity and construction of the Plan and each of its provisions shall be subject to and governed by the laws of the State of New Jersey. 5.7 SEPARABILITY If any provision of this Plan is found, held or deemed to be void, unlawful or unenforceable under any applicable statute or other controlling law, the remainder of this Plan shall continue in full force and effect. 5.8 EMPLOYEE'S RIGHTS This Plan shall not be deemed to constitute a contract of employment between the Company and any Employee or to be a consideration or an inducement for the employment of any Employee. Nothing contained in this Plan shall be deemed to give any Employee the right to be retained in the service of the Company or to interfere with the right of the Company to discharge any Employee at any time regardless of the effect which such discharge shall have upon his or her entitlement to Severance Benefits under this Plan. 8 11 Exhibit 10.13 5.9 ACTION BY THE COMPANY Whenever the Company under the terms of the Plan is permitted or required to do or perform any act or matter or thing, it shall be done and performed by a person duly authorized by its legally constituted authority. ARTICLE VI ERISA PROVISIONS 6.1 CLAIM FOR BENEFITS (a) Any claim for Severance Benefits shall be made to the Administrator. If the Administrator denies a claim, the Administrator may provide notice to the Employee or beneficiary, in writing, within 90 days after the claim is filed unless special circumstances require an extension of time for processing the claim. If the Administrator does not notify the Employee of the denial of the claim within the 90 day period specified above, then the claim shall be deemed denied. The notice of a denial of a claim shall be written in a manner calculated to be understood by the claimant and shall set forth: (1) specific references to the pertinent Plan provisions on which the denial is based; (2) a description of any additional material or information necessary for the claimant to perfect the claim and an explanation as to why such information is necessary; and (3) an explanation of the Plan's claim procedure. (b) Within 60 days after receipt of the above material, the claimant shall have a reasonable opportunity to appeal the claim denial to the Administrator for a full and fair review. The claimant or his or her duly authorized representative may: (1) request a review upon written notice to the Administrator; (2) review pertinent documents; and (3) submit issues and comments in writing. (c) A decision on the review by the Administrator will be made not later than 60 days after receipt of a request for review, unless special circumstances require an extension of time for processing (such as the need to hold a hearing), in which event a decision should be rendered as soon as possible, but in no event later than 120 days after such receipt. The decision of the Administrator shall be written and shall include specific reasons for the decision, written in a manner calculated to be understood by the claimant, with specific references to the pertinent Plan provisions on which the decision is based. 6.2 NAMED FIDUCIARY The Administrator shall be the named fiduciary pursuant to ERISA Section 402 and shall be responsible for the management and control of the operation and administration of the Plan. 9 12 Exhibit 10.13 6.3 GENERAL FIDUCIARY RESPONSIBILITIES The Administrator and any other fiduciary under ERISA shall discharge their duties with respect to this Plan solely in the interest of the Employees and their beneficiaries and: (a) for the exclusive purpose of providing Severance Benefits to Employees and their beneficiaries and defraying reasonable expenses of administering the Plan; (b) with the care, skill, prudence and diligence under the circumstances then prevailing that a prudent person acting in like capacity and familiar with such matters would use in the conduct of an enterprise of a like character and with like aims; and (c) in accordance with the documents and instruments governing the Plan insofar as such documents and instruments are consistent with ERISA. IN WITNESS WHEREOF, the Company has caused this Plan to be adopted and executed by its duly authorized officer, this day of , 19 . ALTEON INC. By: 10
EX-10.19 11 w46067ex10-19.txt CONSULTING AGREEMENT DATED AS OF 12/15/1998 1 Exhibit 10.19 CONSULTING AGREEMENT This Agreement is made and entered into as of December 15, 1998 by and between Alteon Inc., a Delaware corporation whose principal address is 170 Williams Drive, Ramsey, New Jersey 07446 (the "Company"), and Mark Novitch, M.D., an individual whose address is 3558 Albermarle Street NW, Washington, D.C. 20008 ("Chairman"). Whereas, the Company desires to retain Chairman as an independent contractor to act as Chairman of Alteon's Board of Directors starting on December 15, 1998 until the annual meeting in 2000 and until a successor is elected and qualified and Chairman is willing to perform such consulting services, all on the basis set forth more fully herein; NOW, THEREFORE, the parties agree as follows: 1. SERVICES. Chairman agrees to serve as Chairman of the Company's Board of Directors and to carry out assignments for the Company as requested by the Board from time to time or as authorized by the Company's By-laws. In addition to chairing meetings of the Board, it is expected that the Chairman shall dedicate approximately one day per week (as and when appropriate) to the affairs of the Company. Chairman agrees to perform the Services hereunder faithfully, diligently, and to the best of Chairman's skill and ability. 2. CONSULTING FEE. (a) In consideration of the performance of the services called for by this Agreement, the Company agrees to pay Chairman as compensation a retainer of $60,000 per year. To the extent the Chairman is called upon to dedicate materially more time to the affairs of the Company than contemplated by Section 1 of this Agreement, the Company and the Chairman may agree to fix additional compensation therefor. In addition, the Company will issue and deliver stock options to purchase 200,000 shares of the Company's common stock at an exercise price of $.875, the fair market value of Alteon stock on December 15, 1998, when the Compensation Committee and the Board approved this award. The options will be subject to the terms and conditions of the Company's Amended 1995 Stock Option Plan and the Company's Standard Non-Qualified Stock Option Grant Agreement. The options will vest monthly over a two year period. The Board or the Compensation Committee in the exercise of its discretion may elect to accelerate this vesting schedule as a reward for performance. In addition, out of pocket expenses and routine items covered by normal business expense accounts will be covered when traveling and working on behalf of Alteon. The Chairman will submit a list of such expenses. The Company shall therefore promptly make full payment to Chairman in cash of the amount due for the expenses. (b) The Non-Qualified Stock Option Grant Agreement for the options provided for in the preceding paragraph contain provisions to the following effect: -1- 2 Exhibit 10.19 (1) The options shall be transferable to the extent afforded in the Company's 1995 Stock Option Plan and as may be permissible under the applicable registration statement filed by the Company under the Securities Act of 1933. The Company represents that it has available or shall cause to be available sufficient shares under the Plan to cover stock to be issued pursuant to such Plan upon the Chairman's exercise of the options. (2) All unvested options will become exercisable immediately upon a merger, consolidation, acquisition of property or stock, reorganization (other than a mere reincorporation or the creation of a holding company) or liquidation of the Company, as a result of which the shareholders of the Company receive cash, stock or other property in exchange for or in connection with their shares of the Company's Common Stock. In addition, such options shall vest and become exercisable immediately in the event of a change in control of the Company. A change in control of the Company shall be deemed to occur if (a) the Company is merged with or into or consolidated with another corporation or other entity under circumstances where the shareholders of the Company immediately prior to such merger or consolidation do not own after such merger or consolidation shares representing at least fifty percent of the voting power of the Company or the surviving or resulting corporation or other entity, as the case may be, or (b) if the Company is liquidated or sells or otherwise disposes of substantially all of its assets to another corporation or entity, or (c) if any person (as such term is used in Sections 13(d) and 14(d)(2) of the Securities Exchange Act of 1934) shall become the beneficial owner (within the meaning of Rule 13d-3 under such Act) of forty percent (40%) or more of the Common Stock other than pursuant to a plan or arrangement entered into by such person and the Company or otherwise approved by the Board of Directors, or (d) during any period of two (2) consecutive years, individuals who at the beginning of such period constitute the entire Board of Directors shall cease for any reason to constitute a majority of the Board unless the election or nomination for election by the Company's shareholders of each new director was approved by a vote of at least two-thirds of the directors then still in office who were directors at the beginning of the period. (3) In the event that the accelerated vesting caused by Section 4(c)(2) of this Agreement (i) constitutes a "parachute payment" within the meaning of Section 280G of the Internal Revenue Code, and (ii) but for this Section 4(c)(3), would be subject to the excise tax imposed by Section 4999 of the Code (the "Excise Tax"), then the portion of the option which would have become immediately vested and exercisable under Section 4(c)(2) may be reduced to the portion which the Chairman, in his sole discretion, determines would result in no portion, or a lesser portion, of the option being subject to the Excise Tax. The determination by the Chairman of any reduction shall be conclusive and binding upon the Company. The Company shall reduce the portion of the option -2- 3 Exhibit 10.19 which is vested and exercisable only upon written notice by the Chairman indicating the amount of such reduction. 3. EMPLOYMENT TAXES AND BENEFITS. Chairman acknowledges and agrees that it shall be Chairman's sole obligation to report as self-employment income all compensation received by Chairman pursuant to this Agreement. Because Chairman is an independent contractor, Chairman understands that the Company is not obligated to pay any withholding taxes, social security, unemployment or disability insurance or similar items in connection with any payments made to Chairman by the Company pursuant to this Agreement. Chairman shall not be entitled to participate in any plans, arrangements, or distributions by the Company pertaining to any bonus, stock option, profit-sharing, insurance (except as provided in Section 9 of this Agreement) or similar benefits for Company employees. 4. PRE-EXISTING OBLIGATIONS. Chairman represents and warrants that Services performed pursuant to this Agreement will not conflict with any other existing obligation of Chairman to any third party. Chairman will promptly inform the Company in advance of any potential conflicts of interest that may arise due to Chairman's performance of services for any third party and Chairman agrees not to provide services requested by the Company if doing so would conflict with obligations of Chairman to third parties that arose prior to the Company's request for such services. 5. INVENTION ASSIGNMENT, CONFIDENTIAL INFORMATION AND NON-COMPETITION AGREEMENT. In conjunction with this Consulting Agreement the Chairman shall agree to the terms and conditions of the Confidential Disclosure and Non-Use Agreement attached hereto as Exhibit A. 6. TERM. This Agreement shall continue in effect for a period of up to two (2) years, subject to earlier termination as provided in Section 7. 7. TERMINATION. This Agreement may be terminated as follows: (a) upon thirty (30) days written notice; (b) either party may terminate this Agreement in the event of a breach by the other party of any of the covenants contained herein if such breach continues uncured for a period of ten (10) days after written notice of such breach has been given to the breaching party, or (c) this Agreement will terminate automatically if Chairman ceases to serve as Chairman of the Board of Directors of the Company for any reason, including but not limited to, resignation, removal from office or failure to be re-elected by the Board. 8. EFFECT OF TERMINATION. (a) Upon the termination of this Agreement, each party shall be released from all obligations and liabilities to the other occurring or arising after the date of such termination, except that any termination of this Agreement shall not relieve the Company of its obligations under Section 2 hereof to pay Chairman the consulting fee for services performed prior to termination and shall not relieve Chairman of Chairman's obligations under Sections 3, 4 and 5 hereof, nor shall any such termination relieve Chairman or the Company from any liability arising from any breach of this Agreement. Upon any such termination, Chairman shall promptly notify -3- 4 Exhibit 10.19 the Company of all Confidential Information and Designs and Materials in Chairman's possession and, at the expense of the Company and in accordance with the Company's Instructions, shall deliver to the Company all such Confidential Information and Designs and Materials. (b) In the event of termination of this Agreement by the Company pursuant to clause 7(a) hereof, all unvested options shall become exercisable on the effective date of termination., and the Company shall pay the Chairman an amount equal to six (6) months' severance. 9. INDEMNIFICATION. In the event the Chairman is or becomes a party or is threatened to be made a party to or is involved in any action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he is or was a director, Chairman or any other officer of the Company, the Company shall indemnify and hold him harmless to the fullest extent legally permissible under and pursuant to any procedure specified in the General Corporation Law of the State of Delaware, as amended from time to time, against all expenses, liabilities and losses (including attorneys' fees, judgments, fines and amounts paid or to be paid in settlement) incurred or suffered by him in connection therewith. The Company will use its best efforts to obtain insurance to provide the indemnification required by this Section 10, provided that this Agreement shall not require the Company to obtain insurance on other than reasonable commercial terms. 10. NOTICES. Any notices required or permitted hereunder shall be in writing and shall be deemed to have been given when delivered or certified mail, postage prepaid, to the address of the receiving party set forth in this Agreement, or to any other address of the receiving party designated by written notice in accordance with this Section. 11. GOVERNING LAW. This Agreement shall be governed by and construed in accordance with the laws of the State of New Jersey, without regard to its choice of law principles. 12. COMPLETE UNDERSTANDING; MODIFICATION. This Agreement constitutes the entire agreement of the parties and no waiver, modification or amendment of any provision hereof shall be effective unless in writing and signed by the parties hereto. IN WITNESS WHEREOF, the parties hereto have executed this Agreement which is effective as of the date first written above. Alteon Inc. By: /s/Elizabeth O'Dell By: /s/Mark Novitch --------------------------------- -------------------------------- Elizabeth O'Dell Mark Novitch, M.D. VP Finance & Administration -4- 5 Exhibit 10.19 January 17, 2001 Mark Novitch, M.D. 3558 Albemarle Street NW Washington, D.C. 20008 Dear Mark: This letter will set forth our agreement regarding the amendment of the Consulting Agreement (the "Agreement") dated as of December 15, 1998 between you and Alteon Inc. (the "Company"). Section 6 of the Agreement is hereby amended to provide in its entirety as follows: "6. TERM. This Agreement shall continue in effect until June 30, 2001, subject to earlier termination as provided in Section 7." In consideration of the performance of the services called for by the Agreement as amended, in addition to the compensation provided therein, the Company will issue and deliver to you stock options to purchase 50,000 shares of the Company's common stock at an exercise price of $7.00, the fair market value of the Company's stock on November 8, 2000 when the Company's Board of Directors approved this award. The options will vest monthly over the period December 15, 2000 through the end of the term of the Agreement, as amended. Such stock options will be subject to the terms and conditions set forth in Section 2 of the Agreement (other than the terms and conditions relating to the number of shares and the exercise price which terms and conditions are superseded by this paragraph). If the foregoing is acceptable to you, please indicate your agreement by signing and returning the enclosed copy of this letter. Sincerely, KIM/law Enclosure Accepted and Agreed: /s/ Mark Novitch Dated: January 18, 2001 - ------------------------------- ------------------------ Mark Novitch, M.D. EX-23.1 12 w46067ex23-1.txt CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS 1 Exhibit 23.1 CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS As independent public accountants, we hereby consent to the incorporation of our report included in this annual report on Form 10-K, into the Company's previously filed Registration Statements on Form S-8 (33-60576, 333-91437, 333-39428, 333-04496, 333-89134) and Form S-3 (33-44453, 333-48964, 333-28309). ARTHUR ANDERSEN LLP Roseland, New Jersey March 1, 2001
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