-----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, SpwZt+ZmDrBmMxi841ODhyjTwl6FeazcbQnfVxz4rUVXElBTl8FhJVqFnMziqPaq BuXdnrghg2ttRn2/qLvhHA== 0000891618-99-001221.txt : 19990331 0000891618-99-001221.hdr.sgml : 19990331 ACCESSION NUMBER: 0000891618-99-001221 CONFORMED SUBMISSION TYPE: 10-K405 PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 19981231 FILED AS OF DATE: 19990330 FILER: COMPANY DATA: COMPANY CONFORMED NAME: COULTER PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000942416 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943219075 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K405 SEC ACT: SEC FILE NUMBER: 000-21905 FILM NUMBER: 99576977 BUSINESS ADDRESS: STREET 1: 550 CALIFORNIA AVE STE 200 CITY: PALO ALTO STATE: CA ZIP: 94306 BUSINESS PHONE: 4158427300 MAIL ADDRESS: STREET 1: 550 CALIFORNIA AVE STE 200 CITY: PALO ALTO STATE: CA ZIP: 94306 10-K405 1 FORM 10-K405 FOR PERIOD ENDED 12/31/98 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, 1998 [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________ . COMMISSION FILE NO. 0-21905 COULTER PHARMACEUTICAL, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) DELAWARE 94-32190758 (STATE OR OTHER JURISDICTION OF (IRS EMPLOYER IDENTIFICATION NO.) INCORPORATION OR ORGANIZATION) 600 GATEWAY BOULEVARD, 94080 SOUTH SAN FRANCISCO, CALIFORNIA (ZIP CODE) (ADDRESS OF PRINCIPAL EXECUTIVE OFFICES)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: 650-553-2000 SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: NONE SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT: COMMON STOCK $.001 PAR VALUE (TITLE OF CLASS) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ] Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (Section 229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [X] The aggregate market value of the voting stock held by non-affiliates of the Registrant based upon the closing price of the Common Stock listed on the Nasdaq Stock Market(R) on March 12, 1999 was $253,017,897*. The total number of shares outstanding of the Registrant's Common Stock was 16,745,797 as of March 12, 1999. DOCUMENTS INCORPORATED BY REFERENCE Portions of Registrant's Definitive Proxy Statement filed with the Commission pursuant to Regulation 14A in connection with the 1999 Annual Meeting are incorporated herein by reference into Part III of this Report. Certain Exhibits filed with the Registrant's Registration Statement on Form S-1 (Registration Nos. 333-17661 and 333-36607), are incorporated herein by reference into Part IV of this Report. * Based on a closing price of $23.50 per share. Excludes 5,979,078 shares of the Registrant's Common Stock held by executive officers, directors and stockholders whose ownership exceeds 5% of the Common Stock outstanding at March 12, 1999. Exclusion of such shares should not be construed to indicate that any such person possesses the power, direct or indirect, to direct or cause the direction of the management or policies of the Registrant or that such person is controlled by or under common control with the Registrant. - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- 2 PART I Except for historical information contained herein, this Annual Report on Form 10-K contains forward-looking statements which involve risks and uncertainties. All forward-looking statements included in this document are based upon information available to the Company as of the date hereof, and the Company assumes no obligation to update any such forward-looking statements. It is important to note that the Company's actual results could differ materially from those in such forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in "Risk Factors" at the end of Item 1 Business. ITEM 1. BUSINESS Coulter Pharmaceutical is engaged in the development of novel drugs and therapies for the treatment of people with cancer. The Company currently is developing a family of cancer therapeutics based upon two drug discovery programs: therapeutic antibodies and targeted oncologics. Within these broad drug discovery programs, the Company is currently concentrating on two distinct platform technologies: therapeutic antibodies based on conjugated antibody technology and targeted oncologics based on tumor activated peptide ("TAP") pro-drug technology. The Company's most advanced product candidate, Bexxar(TM) (iodine I 131 tositumomab), consists of a monoclonal antibody conjugated with a radioisotope. The Company intends to seek a priority review for the initial approval of Bexxar for the treatment of low-grade and transformed low-grade non-Hodgkin's lymphoma ("NHL") in patients who have relapsed after or are refractory to chemotherapy, while simultaneously pursuing clinical trials to expand the potential use of Bexxar to other indications. In a Phase I/II clinical trial of Bexxar, 42 patients with low-grade or transformed low-grade NHL who had relapsed from previous chemotherapy regimens achieved an 83% overall response rate and a 48% complete response rate. Of those patients who experienced a complete response, the average duration of response was 20.2 months as of July 1997, the date of the final study report. In December 1997, the Company presented data on a multi- center, Phase II clinical trial in heavily pre-treated low-grade and transformed low-grade NHL patients. The patients achieved a complete response rate of 31% of the 45 evaluable patients with the median duration of complete response not yet reached (longest complete response of greater than twenty months). In December 1998, the Company presented data from its pivotal Phase III clinical trial on 60 NHL patients who were refractory to chemotherapy. The results showed, with statistical significance, that more patients experienced remission with a single therapeutic dose of Bexxar compared to their last chemotherapy regimen and that these remissions were of longer duration. The overall response rate was 65% with a median duration of response of 6.5 months. The Company also announced in December 1998, that the United States Food and Drug Administration ("FDA") had designated Bexxar as a Fast Track Product for which the agency will take appropriate actions to expedite development and review. The designation was awarded because one of the targeted indications for the therapy is transformed, low-grade NHL, a life-threatening unmet medical need. The Company believes that Bexxar, if approved, would become the first radioimmunotherapy approved in the United States for the treatment of people with cancer. Significant uncertainty exists as to the extent to which the Fast Track designation will result in a priority review and approval, and this designation does not ensure product approval. The FDA could require additional clinical trials or other information before approving Bexxar. The Company cannot predict the ultimate impact, if any, of the Fast Track designation on the timing or likelihood of FDA approval of Bexxar. The Company intends to pursue additional trials to expand the potential use of Bexxar to other indications. The Company currently is conducting a single-center Phase II trial in newly diagnosed low-grade NHL patients. An interim analysis of data from the first 32 patients showed a 100% overall response rate. Of the 24 patients for whom adequate data was available, 71% achieved complete responses. Additionally, in nine of the patients, no evidence of NHL could be detected at molecular levels using polymerase chain reaction ("PCR") analysis. As of April 1998, 24 patients were in on-going remission, with the longest duration being 18.5 months. 2 3 The objective of the Company's second technology platform, the TAP pro-drug program, is to broaden significantly the therapeutic windows of conventional chemotherapies. The Company currently is developing a pro-drug version of doxorubicin to treat certain solid tumor cancers with the objective of filing an Investigational New Drug ("IND") application in 1999. The Company was incorporated under the laws of Delaware in February 1995. The Company's conjugated antibody program is based upon the antibody therapeutics program which originated in the late 1970s at Coulter Corporation, a recognized leader in the field of hematology. Upon its formation in February 1995, the Company acquired worldwide rights to Bexxar and related intellectual property, know-how and other assets from Coulter Corporation. In October 1997, Coulter Corporation was acquired by Beckman Instruments, Inc., and is now known as Beckman Coulter, Inc. ("Beckman Coulter"). In December 1998, the Company announced a joint collaboration agreement with SmithKline Beecham Corporation ("SB") granting them joint marketing rights in the United States and exclusive commercial rights internationally, except Japan, for Bexxar. BACKGROUND Cancer: The Disease and Its Treatment Cancer afflicts millions of people worldwide. It is currently the second leading cause of death in the United States and is estimated to account for more than 560,000 deaths annually. Some forty percent of Americans are expected to develop cancer and, despite noteworthy success in the treatment of some cancers, about half of these cancer patients will die from the disease. Cancer is a family of more than one hundred diseases that can be categorized into two broad groups: (i) hematologic or blood-borne malignancies (e.g., lymphomas and leukemias) and (ii) solid tumor cancers (e.g., lung, prostate, breast and colon cancers). Both groups are generally characterized by a breakdown of the cellular mechanisms that regulate cell growth and cell death ("apoptosis") in normal tissues. Blood-borne cancers involve a disruption of the developmental processes of blood cell formation, preventing these cells from functioning normally in the blood and lymph systems. Death from blood-borne cancers ultimately is caused by infection, organ failure or bleeding. While chemotherapy is the primary treatment for blood-borne malignancies, many such malignancies are radiosensitive and some localized lymphomas can be treated with radiation therapy. Nonetheless, radiation therapy cannot be used in the treatment of most blood-borne malignancies because the levels of radiation necessary to destroy diseases that are widely disseminated within the body would result in severe damage to the bone marrow of the patient, leading to life-threatening suppression of the immune system, and other serious side effects. In solid tumor cancers, malignant tumors invade and disrupt nearby tissues and can also spread throughout the body or "metastasize." The impact of these tumors on vital organs such as the lungs and the liver frequently leads to death. Surgery is used to remove solid tumors that are accessible to the surgeon and can be effective if the cancer has not metastasized. Radiation therapy also can be employed to irradiate a solid tumor and surrounding tissues and is a first-line therapy for inoperable tumors, but side effects are a limiting factor in treatment. Radiation therapy is used frequently in conjunction with surgery either to reduce the tumor mass prior to surgery or to destroy tumor cells that may remain at the tumor site after surgery. However, radiation therapy cannot assure that all tumor cells will be destroyed and has only limited utility for treating widespread metastases. While surgery and radiation therapy are the primary treatments for solid tumors, chemotherapy and hormonal treatments often are used as adjunctive therapies and also are used as primary therapies for inoperable or metastatic cancers. Chemotherapy, which typically involves the intravenous administration of drugs designed to destroy malignant cells, is used for the treatment of both solid tumors and blood-borne malignancies. Chemotherapeutic drugs generally interfere with cell division and are therefore more toxic to rapidly dividing cancer cells. Since cancer cells can often survive the effect of a single drug, several different drugs usually are given in a combination therapy designed to target overlapping mechanisms of cellular metabolism to overwhelm the ability of cancer cells to develop resistance to chemotherapy. Combination chemotherapy is used widely as 3 4 first-line therapy for leukemias and lymphomas and has had considerable success in the treatment of some forms of these cancers. Nevertheless, partial and even complete remissions obtained through chemotherapy often are not durable, and the patient relapses when the cancer reappears and/or resumes its progression within a few months or years of treatment. The relapsed patient's response typically becomes shorter and shorter with each successive treatment regimen as the cancer becomes resistant to the chemotherapy. Eventually, patients may become "refractory" to chemotherapy, meaning that the length of their response, if any, to treatment is so brief as to lead to the conclusion that further chemotherapy regimens would be of little or no benefit. Chemotherapeutic drugs are not sufficiently specific to cancer cells to avoid affecting normal cells, especially those that are growing rapidly. As a result, patients often experience debilitating side effects such as nausea, vomiting, hair loss, anemia, nerve toxicity and fatigue, as well as life-threatening side effects such as immune system suppression and cardiac toxicity. Such side effects can limit the effectiveness of therapy because the clinician must avoid exceeding the maximum dose of drug that the patient can tolerate. Since dosages must be limited to avoid unacceptable side effects, it may not be possible to administer sufficiently high doses of chemotherapeutic drugs to overcome the natural ability of cancer cells to become resistant. A number of chemotherapeutic agents originally thought to have promise as cancer drugs have failed in the clinic because the minimum effective dose exceeded the maximum tolerable dose. Ideally, a chemotherapeutic agent would have a minimum effective dose well below the maximum tolerable dose, thereby providing physicians with a wide "therapeutic window" or a range of doses within which all patients could be treated effectively. In cases of certain severe blood-borne malignancies and metastatic solid tumor cancers, bone marrow transplants ("BMT") may be performed to treat patients who typically have exhausted all other treatment options. Transplants generally are performed in connection with regimens of aggressive chemotherapy and/or radiation therapy. While techniques are improving, BMTs are associated with side effects and high rates of mortality and morbidity and remain a very expensive alternative. Emerging Methods of Treatment Scientific progress in the elucidation of the underlying molecular biology of cancer in recent years has yielded a number of promising treatment approaches. These approaches generally are designed to enhance the specificity and potency of cancer therapeutics, to improve overall efficacy and to reduce side effects. The Company believes that two of the most promising of these approaches are (i) monoclonal antibodies that bind to targeted cells to stimulate the body's immune system and/or to deliver cytotoxic agents to destroy malignant cells and (ii) modifications of conventional chemotherapeutic drugs and drug formulations to improve efficacy by expanding their therapeutic windows. Monoclonal Antibodies. The human immune system is comprised of specialized cells, including B-cells and T-cells, that function in the recognition, destruction and elimination of disease-causing foreign substances and of virally infected or malignant cells. Human antibodies, which are produced by the B-cells, play a vital role in the proper functioning of the immune system. They have predetermined functions based primarily upon their ability to recognize specific antigens, which are molecular structures on the surface of disease-causing substances or diseased cells. Each antigen serves as a binding site for the antibody specific to that antigen, and each disease-causing substance or diseased cell can be identified by its antigens. The ability of specific antibodies to bind to specific antigens that are expressed on the surface of targeted cells, and to trigger an immune system attack on those cells, provides the theoretical basis for the development of cancer immunotherapeutics. In the 1970s, researchers discovered techniques to produce unlimited supplies of identical murine (mouse-derived) antibodies, referred to as monoclonal antibodies, by cloning antibody producing cells that were derived from hybridization of a single B-cell. These techniques provided researchers with the tools to identify and study specific antigens and to produce potential therapeutics. In principle, once an antigen expressed by malignant cells has been identified, a monoclonal antibody specific to that antigen can be created. If an antibody could be produced that binds to an antigen expressed exclusively by human cancer cells, the antibody would be specific to only those cells. As a result, the use of such a monoclonal antibody as a 4 5 therapeutic would have few, if any, side effects. However, the development of such a therapy has proven to be more problematic than originally hoped. Immunotherapies based solely upon monoclonal antibodies have had only limited clinical effectiveness, particularly in solid tumors where the uneven supply of blood throughout such tumors prevents adequate exposure of monoclonal antibodies to malignant cells. The effectiveness of a particular monoclonal antibody in the treatment of cancer fundamentally is linked to the characteristics of the antigen to which it binds. For example, while researchers have identified numerous antigens on cancer cells that can be recognized by monoclonal antibodies, most of these antigens are also expressed to some degree by other types of cells. An antibody to such an antigen may not be sufficiently specific to the cancer cells to avoid or minimize unintended side effects caused by damage to normal cells. Moreover, the behavior of antigens following binding with an antibody is quite variable: the bound antibody-antigen complex can remain on the cell surface, can be internalized into the cell or can be released from the cell surface. Thus, the identification of suitable antigens to serve as targets for therapeutic monoclonal antibodies must account for these and other complexities. Once a suitable antigen has been identified, researchers have found that different antibodies binding to different sites on the antigen may not have the same biological activity, introducing another element of variability. Antibodies also differ in the degree to which they stimulate an immune system response and in the extent to which they have other effects on the cell. Even the most effective antibodies have limited biological activity. In addition, research conducted since the late 1970s has revealed the importance of selecting the proper type of antibody for use in the intended therapy. Murine antibodies are appropriate in treatments involving a single dose or other short treatment regimen where it is beneficial that the antibodies, together with any therapeutic conjugate, are metabolized and cleared from the body fairly quickly. Chimerized or humanized antibodies are desirable for multi-dose or chronic treatment regimens as they reduce the risk of a human immune response to the antibodies themselves. While these manipulations of the antibodies have permitted more extended therapeutic regimens in some circumstances, they do not overcome the inherent limitations in the biological activity of the underlying antibodies. Thus, despite early expectations, no monoclonal antibody has yet been shown to be effective as a stand-alone, first-line therapy in the treatment of cancer. Researchers have attempted to increase the effectiveness of antibodies by attaching radioisotopes or other cytotoxic agents for use in "radioimmunotherapy" or "chemoimmunotherapy," respectively. By using an antibody to deliver a radioisotope or other cytotoxic agent to the targeted cells, the effect of the radiation or cytotoxic agent can be concentrated in the immediate vicinity of malignant cells. Development of effective radioimmunotherapies, however, presents an additional set of challenges, including the need to select an appropriate radioisotope for the intended therapy, to develop a reliable means of linking the radioisotope to the antibody and to devise a therapeutic protocol that optimizes therapeutic effect while minimizing undesirable side effects. The development of effective chemoimmunotherapies presents similar challenges. Enhancements of Conventional Chemotherapies. A number of organizations have explored methods of improving the delivery of cytotoxic drugs to tumor cells, with the objective of expanding the therapeutic window for these drugs in the treatment of cancer. Approaches that have been commercialized include encapsulation of the drug in a liposome to regulate the rate at which it is released and impregnation of an implantable matrix with the drug to enable its delivery locally over time as the matrix dissolves. Sustained release of cytotoxic drugs using liposomal formulations has modestly enhanced the therapeutic window for these compounds, but instability of the formulations and accumulations in the skin have produced undesirable side effects. Surgical implantation of a matrix is limited inherently to the treatment of localized tumor masses and is not applicable to blood-borne or metastatic cancers. Another approach, the development of pro-drugs, involves the chemical modification of cytotoxic drugs to render them inactive until they are delivered to, or into the proximity of, targeted cancer cells. The pro-drug is transformed into its active form only in the presence of enzymes or other chemicals produced by the tumor cells. The preferential activation of a pro-drug in the tumor milieu increases its lethal effect on tumor cells while limiting side effects to non-malignant tissues. Pro-drug versions of cytotoxic drugs offer the potential to broaden significantly the therapeutic windows of such drugs beyond that which can be achieved using existing 5 6 approaches such as liposomal formulations. Challenges that have constrained the development of effective pro-drugs to date have included the inability to construct or identify suitable tumor-specific activation mechanisms and difficulties in designing pro-drugs that will have adequate stability in circulation. COULTER PHARMACEUTICAL'S APPROACH Coulter Pharmaceutical is developing a family of cancer therapeutics to address the shortcomings of current therapies based upon two drug discovery programs: therapeutic antibodies and targeted oncologics. Within these broad drug discovery programs, the Company is currently concentrating on two distinct platform technologies: therapeutic antibodies based on conjugated antibody technology and targeted oncologics based on tumor activated peptide pro-drugs. The Company is developing conjugated antibody therapies to overcome the inherent limitations of monoclonal antibodies when used as stand-alone therapeutics and to provide advantages over current chemotherapy and radiation therapy treatments. The Company believes that Bexxar, its first product candidate, incorporates each of the principal attributes of an effective radioimmunotherapy for the treatment of NHL: (i) an antigen specific to B-cells, (ii) a therapeutically active monoclonal antibody, (iii) the radioisotope appropriate for the disease profile, and (iv) an optimized therapeutic protocol. The Company intends to file a Biologic License Application ("BLA") with the FDA in 1999 for the use of Bexxar for the treatment of low-grade and transformed low-grade NHL in patients who have relapsed after or are refractory to chemotherapy. The Company intends to seek priority review and marketing approval for Bexxar, while simultaneously pursuing clinical trials to expand its potential uses to other indications. The Company believes that Bexxar, if successfully developed, would be the first radioimmunotherapy approved in the United States for treatment of people with cancer. The Company believes that radioimmunotherapies will emerge as important treatments for blood-borne cancers due to the radiosensitivity of these malignancies and the ready accessibility of the blood and lymph systems to monoclonal antibodies. Radioimmunotherapy also may become an important adjunctive therapy for the treatment of certain solid tumor cancers following surgery, radiation therapy or chemotherapy, where it may be useful in eliminating circulating and other undetected malignant cells missed by primary therapies. In the future, the Company intends to use its expertise in conjugated antibodies to expand beyond radioimmunotherapy to develop effective chemoimmunotherapies for the treatment of certain cancers. The Company's second technology platform, its TAP pro-drug technology, has the potential to broaden significantly the therapeutic windows of conventional chemotherapies based on the Company's understanding of biochemical mechanisms involved in metastasis and the identification of a potential means for exploiting these mechanisms. TAP pro-drug versions of existing cytotoxic drugs are designed to be activated preferentially in the proximity of metastatic cancer cells, yet stable in circulation and in normal tissues. Accordingly, relatively larger quantities of cytotoxic agents are expected to reach and enter malignant cells as opposed to normal cells, which could permit a significant increase in maximum tolerated dosages, potentially overcoming drug resistance in cancer cells. The Company also believes that cytotoxic agents currently considered too toxic to be used in their unmodified forms may be suitable candidates to become TAP pro-drugs. COULTER PHARMACEUTICAL'S STRATEGY The Company's goal is to develop and commercialize novel drugs and drug therapies for the treatment of people with cancer based on selected insights from the emerging understanding of the molecular biology of malignant cells. The Company's conjugated antibody program is based upon the antibody therapeutics program which originated in the late 1970s at Beckman Coulter, a recognized leader in the field of hematology. Upon its formation, Coulter Pharmaceutical obtained worldwide rights to Bexxar and related intellectual property, as well as a significant body of expertise pertaining to the selection and development of suitable antibodies and appropriate radioisotopes (and other cytotoxic agents) and methods for devising optimized therapies. The Company's TAP pro-drug program is based upon technology that has been under development at Universite Catholique de Louvain, Belgium, since 1986 and which was exclusively licensed to 6 7 the Company in 1996. Based on this foundation, the Company has established a strategy comprised of the following primary elements: Pursue Expedited Approval of Bexxar. The Company intends to seek expedited FDA review for marketing approval for Bexxar for the treatment of low-grade and transformed low-grade NHL in patients who have relapsed after or are refractory to chemotherapy, while simultaneously pursuing clinical trials to expand the potential use of Bexxar to other indications. The Company intends to file for FDA marketing approval for this indication in 1999. In December 1998, the Company announced that the FDA had designated Bexxar as a Fast Track Product for which the agency will take appropriate actions to expedite review and development. The Company also intends to seek approval for other NHL indications based on additional clinical trials, and has commenced a Phase II clinical trial of Bexxar as a stand-alone, first-line treatment for patients with newly diagnosed low-grade NHL. Establish Sales and Marketing Capability. The Company intends to market and sell its products in the United States through a direct sales force and, where appropriate, in collaboration with marketing partners. This strategy is intended to enable the Company to establish a commercial presence in the cancer therapeutics market with Bexxar, if approved, and to create the capability to sell other products that it may develop or in-license. The Company believes that an established sales and marketing capability will enable it to compete effectively for opportunities to license or distribute later-stage product candidates and approved products. Internationally, the Company intends to distribute its products through marketing partners. In December 1998 the company entered into an agreement with SB to jointly commercialize Bexxar. The two companies will co-promote Bexxar in the United States following regulatory approval with each company fielding its own sales force and both companies sharing profits equally. Outside the Unites States, excluding Japan, the Company has granted SB exclusive marketing and distribution rights for Bexxar in return for product royalties and milestone payments. Leverage Existing Technology Platforms. The Company intends to develop additional products based on the lead compounds being generated in its TAP pro-drug program and by leveraging its expertise in conjugated antibodies to develop other immunotherapies. In its TAP pro-drug program, the Company currently is engaged in preclinical development of Super-Leu-Dox, a pro-drug version of doxorubicin, with the objective of filing an IND in 1999 and commencing clinical trials in 2000. The Company also intends to apply its TAP pro-drug technology to other classes of cytotoxic drugs to broaden significantly the therapeutic windows of such agents. The Company is evaluating potential conjugated antibody therapies for the treatment of other blood-borne malignancies and selected solid tumor cancers. Leverage Development Expertise. The Company believes that it has built substantial product development capabilities and expertise in the cancer field due in part to the advanced stage of the Bexxar program since the time that it was obtained from Coulter Corporation. The Company believes it can leverage this development expertise to accelerate the development of other products in the cancer therapeutics field. The Company intends to pursue other product candidates derived from sponsored research or available for in-licensing in both blood-borne malignancies and solid tumor cancers, particularly in areas that may be complementary to its existing technology platforms. Utilize Contract Manufacturers. The Company intends to manufacture its commercial products through contract manufacturers. This strategy is expected to (i) accelerate the scale-up of manufacturing processes to commercial scale, (ii) reduce initial capital investment, (iii) result in competitive manufacturing costs, and (iv) provide access to a wide range of manufacturing technologies. BEXXAR: RADIOIMMUNOTHERAPY FOR NON-HODGKIN'S LYMPHOMA The Company plans to file a BLA with the FDA in 1999 for its first product candidate, Bexxar. The Company believes that Bexxar, if successfully developed, would become the first radioimmunotherapy approved in the United States for the treatment of people with cancer. 7 8 Non-Hodgkin's Lymphoma and Its Current Treatment Non-Hodgkin's lymphomas are blood-borne cancers of the immune system, all sharing the common feature of a proliferation of malignant B-cells. According to statistics from the National Cancer Institute, approximately 270,000 people are afflicted with NHL in the United States. More than 56,000 new cases are expected to be diagnosed in 1999. NHL is currently the sixth leading cause of death among cancers in the United States and has the second fastest growing mortality rate. NHL is categorized by histology as either low-, intermediate- or high-grade disease. These classifications differ significantly with respect to the speed of disease progression, the pattern of response to and relapse after conventional chemotherapy and the average life expectancy. In relapsed low-grade patients, the disease can transform to an intermediate- or high-grade histology ("transformed low-grade NHL"). In the United States, the Company estimates that approximately 140,000 patients have low-grade or transformed low-grade, 100,000 have intermediate-grade and 30,000 have high-grade NHL. Initially, the Company is pursuing clinical development of Bexxar for the treatment of patients with low-grade and transformed low-grade NHL. Patients with low-grade NHL have a fairly long life expectancy from the time of diagnosis with a median survival of more than six years. While patients with low-grade and transformed low-grade NHL can often achieve one or more remissions with chemotherapy, these patients eventually relapse. Relapsed patients are more difficult to treat as remissions are harder to achieve and, if achieved, last for shorter periods of time as the disease becomes more resistant to chemotherapy and/or transforms to an intermediate- or high-grade histology. Patients ultimately die from the disease or from complications of treatment. Intermediate- and high-grade NHL are more rapidly growing forms of the disease. However, approximately one-half of all intermediate- and high-grade cases can be treated effectively with conventional chemotherapy. Description of Bexxar Bexxar consists of a radioisotope, (131)Iodine ("(131)I"), combined with a monoclonal antibody that recognizes and binds to the CD20 antigen, an antigen commonly expressed on the surface of B-cells primarily during that stage of their life cycle when NHL arises. Bexxar is administered to patients in a proprietary therapeutic protocol consisting of a single, two-dose regimen. The Company believes that the potential benefits of Bexxar result from the following four constituent elements: Proprietary Protocol. Bexxar is administered intravenously in a single, two-dose regimen consisting of a dosimetric dose, three whole body gamma counts and a therapeutic dose. The Company has rights in two issued patents relating to methods for radioimmunotherapy and dosing using Bexxar and other anti-CD20 antibodies. The proprietary protocol is flexible: the timing of the counts and of the therapeutic dose can be adjusted to some extent to accommodate the schedules of clinicians and patients. The chart below depicts the protocol being used in the Company's current clinical trials. The dosimetric dose consists of 35 mg of Anti-B1 Antibody trace-labeled with 5 millicuries ("mCi") of (131)I. Immediately after the dosimetric dose, the patient undergoes a whole body gamma count. The patient returns for two additional counts on the second, third or fourth and the seventh or eighth days of the therapy to show how much of the radiolabeled antibody has been eliminated from the body at each point in time. This information is used to calculate the correct individualized therapeutic dose to achieve a total body radiation of 75 centiGray ("cGy"). The amount of radiolabeled antibody needed to achieve this optimal dose ranges from approximately 40 to 200 mCi of (131)I due to wide patient-to-patient variability in the rates at which the antibody is eliminated. The therapeutic dose is administered once from seven to fourteen days after the dosimetric dose. Both the dosimetric dose and the therapeutic dose are preceded by a 450 mg dose of unlabeled Anti-B1 Antibody to improve the targeting of malignant B-cells by the radiolabeled Anti-B1 Antibody. These pre-doses of unlabeled Anti-B1 Antibody optimize the distribution of radiolabeled antibody in patients with bulky disease or large spleens, minimize the required dose by slowing its elimination from the body and may also contribute to the overall efficacy of the product. Additionally, the patient takes non-radioactive iodine drops orally during the course of the therapy to prevent uptake of (131)I into the thyroid gland. 8 9 [IMAGE] Relying upon the dosimetric properties of (131)I to account for critical patient-to-patient variability in the rate at which the antibody is cleared makes it possible to deliver predictably a total body radiation dose that has been determined to maximize therapeutic benefit with manageable side effects and without the need for bone marrow rescue. Because Bexxar is administered in a single, two-dose regimen and is well tolerated, it is expected to require relatively little patient follow-up and physician intervention. In contrast, chemotherapy requires administration of several cytotoxic agents in repeated cycles of therapy over a six- to eight-month period during which the patient must be monitored carefully and/or treated for side effects. Until recently, patients have been kept in the hospital to monitor radiation levels for up to four days following the therapeutic dose. However, under new Nuclear Regulatory Commission ("NRC") regulations, patients are increasingly being treated with Bexxar on an outpatient basis. Although the Company believes that Bexxar can be administered primarily on an outpatient basis, some hospitals may be required to administer the therapeutic dose on an inpatient basis under their own or under applicable state or local regulations. See "-- Radioactive and Other Hazardous Materials." CD20 Antigen. The CD20 antigen is a highly selective cell surface marker found on B-cells: expression of the CD20 antigen is limited to B-cells, is found on 95% of such cells and occurs on B-cells primarily during that stage of their life cycle when NHL arises. The CD20 antigen is not expressed by stem cells, B-cell progenitor cells or plasma cells; thus, these cells are not targeted by Bexxar. As a result, while Bexxar targets and destroys both normal and malignant B-cells, unaffected plasma cells continue to function in the immune system and B-cell populations can be regenerated after therapy by unaffected B-cell progenitor cells. [IMAGE] In addition, the CD20 antigen is neither internalized by the B-cell nor released into circulation after it has been bound to the Anti-B1 Antibody, ensuring that the antibody-radioisotope conjugate will remain in place to destroy the B-cell. The Anti-B1 Antibody. The Anti-B1 Antibody exhibits very high specificity for the CD20 antigen and, because it is a sub-class IgG(2a) antibody, is capable of recruiting an immune response to those B-cells to which it binds. Further, the Anti-B1 Antibody directly affects cell function, triggering apoptosis in a portion of the B-cells to which it binds. The use of a murine antibody promotes rapid clearance of unbound radiolabeled 9 10 antibody from circulation, which reduces radiotoxicity. Due to the impaired state of the NHL patient's immune system and the short course of therapy, the development of antibodies to the murine antibody has been minimal to date and has not been a limiting factor in treatment under the protocol. The Anti-B1 Antibody used in Bexxar was generated in 1978 by the Dana-Farber Cancer Institute in collaboration with Coulter Corporation. The Anti-B1 Antibody has been available commercially from Coulter Corporation (now Beckman Coulter) as a diagnostic reagent since 1982 and is generally accepted as the reference standard for the identification of B-cells. Rights to the antibody for therapeutic applications were transferred to Coulter Pharmaceutical from Coulter Corporation in February 1995. (131)Iodine Radioisotope. The (131)I radioisotope used in Bexxar was selected over other radioisotopes because it (i) produces both gamma emissions which permit dosimetry for dose optimization and compact beta emissions for a concentrated therapeutic effect, (ii) provides additional commercial and clinical benefits based on its relatively long half-life, (iii) has characteristics which reduce the risk of bone marrow damage without sacrificing efficacy, and (iv) has long-established medical uses in other cancer treatments. Gamma emissions from (131)I permit dose optimization by enabling clinicians to calculate the actual clearance rate of radiolabeled antibody for each patient. Use of the same radioisotope for both the dosimetric and the therapeutic dose provides assurance that the clearance rates observed in dosimetry also will apply for the therapeutic dose. Having established the patient's actual clearance rate, the clinician can determine reliably the therapeutic dose which will deliver the optimized level of total body radiation. The comparatively lower energy and shorter path length of the beta emission of (131)I concentrate the destructive energy of the radioisotope on the B-cell to which the antibody is bound and to adjacent microscopic clusters of malignant cells which are common to NHL. Moreover, (131)I causes minimal damage to nearby normal tissues in contrast to other radioisotopes that have longer path length beta emissions which may extend too far beyond the targeted area. The relatively long half-life of (131)I, approximately eight days, permits radiolabeling at a centralized facility to ensure consistent quality, increase the number of clinical sites capable of administering this radioimmunotherapy and reduce overall manufacturing costs. The eight-day half-life also provides the therapeutic advantage of exposing bound malignant cells to radiation over a longer period of time than other radioisotopes with shorter half-lives. When bound to a B-cell, (131)I's energy and short path length, together with its relatively long half-life, minimize bone marrow damage while optimizing the therapeutic effect of the radiation. Further, as the Anti-B1 Antibody is metabolized, the released (131)I radioisotope is eliminated rapidly and unlike some other radioisotopes does not concentrate naturally in the bone matrix. (131)Iodine is currently an inexpensive radioisotope that has long-established medical uses in other cancer treatments. Hence, medical facilities and clinicians are accustomed to its handling, use and disposal and already have developed the appropriate procedures and facilities for its safe therapeutic application. Clinical Results and Development Plan The initial study of Bexxar was a Phase I/II dose escalation clinical trial at the University of Michigan Medical Center which completed patient enrollment in early 1996. This trial was used to develop and refine the proprietary therapeutic protocol, to determine the maximum tolerated dose of total body radiation and to assess the safety and efficacy profile of treatment with the radiolabeled Anti-B1 Antibody in patients representing a full range of NHL histologies. Based on the data generated in this clinical trial, the Company has pursued clinical development of Bexxar for the treatment of low-grade and transformed low-grade NHL. The following definitions apply to all discussions of the results of the Company's clinical trials: A "complete response" is defined as the disappearance of all detectable disease and all signs and symptoms of the disease. A "partial response" is defined as a greater than 50% reduction in tumor measurement. The "overall response" rate combines complete response with partial response. Complete and partial response classifications also require that there be no progression at any disease site and no new sites of disease. 10 11 Phase I/II Trial Results. A total of 59 patients were enrolled in the Phase I/II dose escalation clinical trial. Preliminary data from this clinical trial were first published in August 1993 in the New England Journal of Medicine and updated, interim clinical results were reported in July 1996 in the Journal of Clinical Oncology. Of the 59 patients enrolled in this trial, 42 had low-grade or transformed low-grade NHL, which are the histologies the Company has pursued in its clinical trials. These 42 patients, who had failed on average more than four prior treatment regimens with chemotherapy, achieved an 83% overall response rate, with a 48% complete response rate and a 35% partial response rate. This 42-patient cohort included eight patients who previously had received and failed an autologous bone marrow transplant prior to participation in the clinical trial. The 42 patients in this cohort received total body radiation doses of up to 85 cGy in this dose escalation trial. Four of the 42 patients did not receive the therapeutic dose of radiolabeled antibody due to their rapidly deteriorating medical condition or the presence of an antibody response to the murine antibody, which arose prior to May 1993 in the early stages of the Phase I/II dose escalation clinical trial under the yet to be optimized treatment protocol. Of the 38 patients who received a therapeutic dose, 53% experienced a complete response with an average duration of response of 20.2 months, with a range of five to 46 months as of July 1997. As of such date, nine of these patients were still in complete response. On an intent-to-treat basis, which includes all enrolled patients whether treated or not, the 59 enrolled patients achieved an overall response rate of 71%, with a complete response rate of 34% and a 37% partial response rate. Of the 17 patients in this trial who had intermediate- or high-grade NHL, the overall response rate was 41%, with no complete responders. While this data is encouraging, the Company currently is pursuing clinical development of Bexxar in low-grade and transformed low-grade NHL patients. Bexxar was generally well tolerated by patients. Dose limiting side effects were hematologic, consisting primarily of reversible declines in blood cell counts. These toxicities were generally mild to moderate, with no patient requiring stem cell rescue. Other side effects observed were mild and consisted primarily of temporary flu-like symptoms. As part of its phase I/II dose escalation study, 13 patients who had responded to an initial treatment with Bexxar were retreated following relapse. Data concerning there patients was presented at the American Society of Clinical Oncology meeting in May 1998. Eight of the 13 patients responded to treatment with four of the 13 patients experiencing a complete response. In patients who had achieved a complete response after initial treatment with Bexxar, five of six experienced an overall response and three of six achieved a second complete response. Phase II Dosimetry Validation Clinical Trial. The Company completed a multi-center dosimetry validation clinical trial in a total of 47 patients with relapsed or refractory low-grade and transformed low-grade NHL in order to demonstrate that Bexxar's treatment protocol could be implemented consistently at multiple clinical sites. During this trial, the Company refined its proprietary protocol to streamline the therapeutic dose calculation, establishing that accurate antibody elimination rates could be determined from three gamma camera scans. Overall, 45 of the 47 enrolled patients were evaluable, having received the protocol-specified therapy. The evaluable patients had received on average, over four prior therapies, 42% had bulky disease (tumor burden of greater than 500 grams), and 53% had not responded to their last chemotherapy. Of the evaluable patients, 31% (14 patients) achieved a complete response. Ten of the 14 patients with a complete response had not relapsed with the longest duration of response exceeding 20 months as of December 1997. As of that date, the median duration of complete response had not been reached. None of the evaluable patients developed human anti-mouse antibodies. A complete response was achieved at each clinical site involved in the trial. Phase III Pivotal Trial. In December 1998, the Company presented results from its pivotal Phase III trial of 60 NHL patients refractory to chemotherapy. The patients represented a difficult-to-treat group, having either no response to prior chemotherapy, or disease progression within six months of their last chemotherapy regimen. The primary clinical endpoint was the comparison between the patient's duration of remission on Bexxar and the duration of remission on the patient's last chemotherapy, as assessed by a masked, randomized review of efficacy data by an independent panel of physicians. Of the 41 cases where response durations to chemotherapy and Bexxar were not equivalent, 32 patients (78 percent) experienced a 11 12 longer duration of response to Bexxar compared to only nine patients (22 percent) who experienced a longer duration of response to prior chemotherapy. The median duration of remission on Bexxar was 6.5 months, approximately doubling the 3.4-month median duration of remission experienced on their last chemotherapy. At December 1998, the longest duration of remission in this trial with Bexxar was ongoing at 17.3 months. The overall response rate, a secondary clinical endpoint, also was significantly greater on Bexxar with 39 of 60 patients (65 percent) responding to Bexxar compared to only 17 of 60 patients (28 percent) responding to prior chemotherapy. In addition, ten of 60 Bexxar-treated patients (17 percent) experienced a complete remission (or complete elimination of signs and symptoms of the disease) compared to only two of 60 patients (3 percent) who experienced a complete remission on prior chemotherapy. Bexxar was well tolerated with mild to moderate non-hematologic toxicity and acceptable hematologic toxicity. Results presented are based upon interim data which have been submitted to the FDA, certain portions of which have not yet been published in a peer reviewed publication. No assurance can be given that the Company's future clinical results will be consistent with the results of the Phase I/II dose escalation, the Phase II dosimetry validation and the Phase III pivotal clinical trials, which were conducted at relatively few sites with a relatively small number of patients per NHL histology and disease stage and some of which had different clinical objectives than the Company's current or planned clinical trials. See "Risk Factors -- Uncertainties Related to Product Development." Clinical Development of Bexxar Based on the foregoing results of the Phase I/II, Phase II dosimetry validation and Phase III pivotal clinical trials, the Company will rely on three additional clinical trials to support an application to the FDA for the initial marketing approval of Bexxar expected to be filed in 1999; (i) interim data from an ongoing expanded access clinical trial, (ii) interim data from an ongoing Phase II clinical trial to evaluate the extent to which the therapeutic benefit of Bexxar is derived from the combination of the Anti-B1 Antibody and the radioisotope, in comparison to the Anti-B1 Antibody alone; and (iii) to expand the use of Bexxar to other indications and to support the initial BLA, interim data from an ongoing Phase II clinical trial of Bexxar as a first-line treatment for patients with low-grade NHL and intends to conduct additional clinical trials in the future. The Company's collaboration agreement with SB provides for SB to participate in the administration, management and funding of certain current and future clinical trials. Expanded Access Clinical Trial. The Company currently is conducting a multi-center expanded access trial for patients with NHL who have failed prior chemotherapy. The program was established by the Company in response to requests from physicians and patients for continued access to Bexxar during the period prior to potential FDA marketing approval. The trial is expected to include approximately 100 community and academic oncology centers across the United States. Phase II Unlabeled Versus Labeled Antibody Clinical Trial. The Company is conducting a multi-center Phase II clinical trial in 78 patients with relapsed, low-grade and transformed low-grade NHL. Patients are randomized into two groups: one group receives Bexxar pursuant to the proprietary protocol; the other group receives two 485 mg doses of unlabeled Anti-B1 Antibody eight days apart in a treatment regimen that is parallel to Bexxar. The objective of this clinical trial is to assess the incremental clinical activity from radiolabeling the Anti-B1 Antibody as compared to the clinical activity of the unlabeled Anti-B1 Antibody alone. Administration of the unlabeled Anti-B1 Antibody has not been designed for use as a stand-alone therapy, nor has the treatment regimen been optimized for such use. This trial was the subject of an abstract presented at the 1997 American Society of Therapeutic Radiation Oncology meeting in October 1997. The Company's objective is to complete enrollment of patients in this clinical trial in 1999. Phase II First-Line, Stand-Alone Treatment Clinical Trial. The Company currently is conducting a single-center Phase II trial in up to 80 newly diagnosed low-grade NHL patients. An interim analysis of data from the first 32 patients presented at the American Society of Clinical Oncology meeting in May 1998 showed a 100% response rate with 71% achieving a complete response. Additionally, in nine of the patients, no evidence of NHL could be detected at molecular levels using PCR analysis. As of April 1998, 24 patients were in ongoing remission, with the longest duration being 18.5 months. Side effect were generally mild to moderate 12 13 and self-limited. The Company believes that its Phase II trial of Bexxar for patients newly diagnosed with NHL is the first trial of radioimmunotherapy as a stand alone, first-line treatment for people with cancer. The Company's objective is to complete enrollment of patients in this clinical trial in the first half of 1999. The ability of the Company to conduct and complete its ongoing and planned clinical trials in a timely manner is subject to a number of uncertainties and risks, including the rate at which patients can be accrued in each clinical trial, the Company's ability to obtain necessary regulatory approvals, the capacity of the Company's contract manufacturers to supply unlabeled and radiolabeled Anti-B1 Antibody as needed for patient treatment and the occurrence of unanticipated adverse events. Any suspension or delay of one or more of such clinical trials could have a material adverse effect on the Company's business, financial condition and results of operation. See "Risk Factors -- Uncertainties Related to Product Development," "-- Government Regulation; No Assurance of Regulatory Approvals," and "-- Dependence on Suppliers; Manufacturing and Scale-up Risk." Use of Bexxar for Bone Marrow Transplantation. The radiolabeled Anti-B1 Antibody has been the subject of other clinical trials to assess the efficacy of using the radiolabeled Anti-B1 Antibody to deliver the high levels of radiation necessary to prepare patients for autologous bone marrow transplants. The conventional preparation for autologous bone marrow transplants is chemotherapy and total body irradiation. These clinical trials were designed to determine the maximum tolerated dose, response duration and rates of response, progression-free survival and overall survival. The first of two clinical trials conducted at the University of Washington Medical Center and the Fred Hutchinson Cancer Research Center tested (131)I-labeled Anti-B1 Antibody as a single agent to prepare patients for an autologous bone marrow transplant by achieving a total body radiation level of up to 997 cGy (over ten times Bexxar's dose). As reported in The Lancet in August 1995, of the 21 patients receiving the full radiotherapeutic regimen, the overall response rate was 86%, with a 76% complete response rate and a 10% partial response rate. Interim data from this clinical trial were published in the New England Journal of Medicine in October 1993. The second clinical trial, currently ongoing, is designed to test the combination of similarly high doses of radiolabeled Anti-B1 Antibody and high doses of chemotherapy in preparation for autologous bone marrow transplant. This clinical trial has enrolled 43 patients since its commencement in January 1995. Data from this clinical trial was presented at the American Society of Clinical Oncology meeting in May 1998. In this Phase I/II trial, 28 of 43 patients (65%) had low grade and 15 of 43 patients (35%) had intermediate or high grade NHL. Of the 42 evaluable patients, 31 of 42 patients (74%) are progression-free after a median follow-up of 1.5 years. All patients experienced myelosuppression by design with the high dose combination regimen of chemotherapy and Bexxar (at a level approximately four to ten times the mean standard dose of Bexxar). Other dose-limiting toxicities included pulmonary and gastrointestinal toxicities. In addition, a Phase II dose escalation clinical trial is ongoing at the University of Nebraska for the combined use of standard dose radiolabeled Anti-B1 Antibody and high dose chemotherapy as preparation for autologous bone marrow transplant. Other Clinical Trials. The Company is also conducting a Phase I multi-center investigational trial in patients previously treated with Bexxar. This open label trial includes low-, intermediate-, and high-grade NHL patients who have relapsed from their initial Bexxar treatment. 13 14 TAP PRO-DRUG PLATFORM The Company's second technology platform, its tumor-activated peptide pro-drug technology, has the potential to broaden significantly the therapeutic window of cytotoxic agents. The TAP pro-drug technology is based upon an understanding of the biochemical mechanisms utilized by cancer cells to metastasize and the identification of a potential means for exploiting these mechanisms and is being developed in collaboration with the Universite Catholique de Louvain, Belgium. TAP pro-drugs are designed to be (i) activated preferentially at the tumor site by enzymes secreted by the tumor, (ii) stable in circulation and in normal tissues and (iii) unable to penetrate normal cells or malignant cells until activated. As a result, relatively larger quantities of cytotoxic agents are expected to reach and enter malignant cells as opposed to normal cells, which could permit a significant increase in maximum tolerated dosages, potentially overcoming drug resistance in cancer cells. The Company's lead preclinical pro-drug candidate is a pro-drug version of doxorubicin known as Super-Leu-Dox. Doxorubicin is an off-patent chemotherapeutic drug which currently is used in the treatment of a number of solid tumor cancers, including breast, prostate, ovarian and soft-tissue sarcoma cancers. [IMAGE] As depicted in the graphic above, Super-Leu-Dox is based on a proprietary peptide of four amino acids (a "tetrapeptide") that can be linked to doxorubicin's active site. In the two-step activation process, (1) the extracellular tumor enzyme cleaves three amino acids from the tetrapeptide leaving a leucine amino acid-doxorubicin conjugate that is able to penetrate cells. (2) The resulting conjugate is then capable of entering cells. Since this first activation step occurs in the immediate vicinity of tumor cells that are secreting the enzyme, the probability that the cytotoxic drug will enter tumor cells as opposed to normal cells is increased. Moreover, the conjugate remains inactive inside the cells until (3) the remaining leucine is removed from doxorubicin's active site by an intracellular enzyme. Although it is expressed in both normal and tumor cells, this intracellular enzyme is present in tumor cells in concentrations three to five times higher than in normal cells. As a result, (4) the doxorubicin is activated to a greater extent in tumor cells relative to normal cells. This two-step activation process is designed to produce a significantly higher ratio of active to inactive doxorubicin in cancer cells relative to normal cells. In in vitro studies of Super-Leu-Dox, researchers have found that the concentration of activated to inactivated doxorubicin in tumor cells was 40 times higher than in normal cells. These results, if confirmed in clinical trials, offer the potential to improve significantly the therapeutic window of doxorubicin. The Company currently plans to complete preclinical development of Super-Leu-Dox and to commence clinical trials in 2000. Prior to the licensing of the TAP pro-drug technology by Coulter Pharmaceutical, an earlier generation leucine-doxorubicin conjugate was tested as a stand-alone therapy for the treatment of solid tumors in two separate dose escalation clinical trials in Europe. A total of 59 patients were enrolled in these clinical trials, and patients safely tolerated doses well in excess of those associated with unmodified doxorubicin. Results from these clinical trials, along with data from preclinical studies, will be used by the Company to select the initial indication to pursue in clinical trials of Super-Leu-Dox. Selection of the particular indication or indications to be evaluated in such clinical trials has not been finalized. 14 15 While the Company will focus initially on previously approved chemotherapeutic drugs, it also is evaluating TAP pro-drug versions of cytotoxic agents currently considered too toxic to be used in their unmodified forms. The Company believes that the TAP pro-drug technology potentially can be applied to several classes of cytotoxic agents, including the vinca alkaloids, which are used commonly to treat blood-borne malignancies and some solid tumors. The Company also plans to develop and evaluate other peptide structures for possible use in pro-drug versions of cytotoxic agents and other cancer therapeutics. Under its agreement with Catholique Universite de Louvain, Belgium, the Company has secured an exclusive license to the intellectual property underlying the program and will pay royalties on sales of licensed products. The agreement also provides for specified minimum payments, including one payment that will be due if the Company should elect to relocate the program outside of Belgium. The amounts of these payments are not material and, in any event, the Company does not currently intend to relocate the research program. In 1997, the Company also entered into a sponsored research agreement with Catholique Universite de Louvain to conduct research in the area of TAP pro-drugs. OTHER PRODUCT CANDIDATES In 1997, the Company began a program which actively seeks to in-license promising product development candidates in the area of cancer therapeutics with the objective of expanding the Company's product pipeline. RESEARCH AND DEVELOPMENT The Company incurred research and development expenses of $13.7 million, $21.0 million, $28.7 million and $66.0 million for the years ended December 31, 1996, 1997 and 1998, and for the period from inception (February 16, 1995) to December 31, 1998, respectively. MANUFACTURING The Company intends to utilize contract manufacturers for most of the preclinical and clinical requirements for its potential products and for all of its commercial needs. This strategy is expected to (i) accelerate the scale-up of manufacturing processes to commercial scale, (ii) reduce initial capital investment, (iii) result in competitive manufacturing costs, and (iv) provide access to a wide range of manufacturing technologies. The Company's collaboration agreement with SB provides for SB to participate in the planning, management and funding of manufacturing development. Pursuant to several contracts with the Company, Lonza Biologics PLC ("Lonza") now is supplying the Anti-B1 Antibody for use in ongoing clinical trials and to meet commercial requirements. There can be no assurance that the material produced by Lonza will be suitable for human use and that clinical trials or commercial supply will not be delayed or disrupted if Lonza is unable to meet the Company's demand for product. In addition, the Company has entered into agreements with Boehringer Ingleheim Pharma KG ("BI Pharma KG") to manufacture and supply Anti-B1 Antibody for use in ongoing clinical trials and to meet commercial requirements as well as provide for fill/finish and packaging services. The Company has committed to minimum order quantities of the Anti-B1 antibody from BI Pharma KG. The maximum amount of the penalty which would be payable if the Company did not place orders to purchase any antibody is approximately $5.4 million. There can be no assurance that the material produced by BI Pharma KG will be suitable for human use and that clinical trials or commercial supply will not be delayed or disrupted if Pharma KG is unable to meet the Company's demand for product. Radiolabeling currently is conducted at MDS Nordion Inc.'s ("Nordion") centralized radiolabeling facility. The Company has several contracts with Nordion that provide for radiolabeling services for clinical and commercial product. There can be no assurance that material produced by Nordion will be suitable for human use and clinical trials or commercial supply will not be delayed or disrupted if Nordion is unable to meet the Company's demand for product. 15 16 If Bexxar is successfully developed and is approved for marketing by the FDA, the Company expects that production for commercialization will consist of (i) production of bulk Anti-B1 Antibody by Lonza and BI Pharma KG, (ii) filling and labeling of individual product vials with Anti-B1 Antibody by another third-party supplier and/or BI Pharma KG, and (iii) radiolabeling of Anti-B1 Antibody at Nordion. While the Company plans to develop additional suppliers of these services, it expects to rely on its current suppliers for all or a significant portion of its requirements for Bexxar for the foreseeable future. Radiolabeled antibody cannot be stockpiled against future shortages due to the eight-day half-life of the (131)I radioisotope. Accordingly, any change in the Company's existing or planned contractual relationships with, or interruption in supply from, its third-party suppliers could adversely affect the Company's ability to complete its ongoing clinical trials and to market Bexxar, if approved. Any such change or interruption would have a material adverse effect on the Company's business, financial condition and results of operations. See "Risk Factors -- Dependence on Suppliers; Manufacturing and Scale-up Risk." The Company believes that the products it expects to develop in its TAP pro-drug program can be produced with standard chemical synthesis processes and expects to utilize third parties to meet clinical trial and any commercial requirements for these products. The Company is in discussions with potential manufacturers of Super-Leu-Dox, its initial TAP pro-drug product candidate. There can be no assurance that agreements will be entered into in a timely manner or under acceptable terms or that the material produced under the agreements will be suitable for human use. DISTRIBUTION The unique properties of the Bexxar therapy require the distribution of the product to be tightly controlled. Due to its radioactive component, the product is shipped in a shielded container and must arrive at its destination within 24 - 48 hours of production. The product must also be under controlled temperature during shipment. The company will rely on many third parties to process orders and to package, store and ship the product. The Company is working with these suppliers to establish a commercial scale system for the product which will minimize risk and loss of inventory and provide efficient service to customers. There can, however, be no assurance that these third parties will handle the product in a manner that will minimize loss and damage of inventory. The Company is in the process of negotiating several contracts for the handling of the product before it is delivered to the customer. There can be no assurance that the Company will be able to enter into such agreements on commercially reasonable terms, on a timely basis or at all. MARKETING AND SALES The Company intends to market and sell its products in North America through a direct sales force and, where appropriate, in collaboration with marketing partners. This strategy is intended to enable the Company to establish a commercial presence in the cancer therapeutics market with Bexxar, if approved, and to create the capability to sell other products that it may develop or in-license. The sales force is expected to initially call on oncologists, hematologists and nuclear medicine physicians in connection with the sale of Bexxar. The Company initially will focus its sales efforts on those physicians who treat the largest volume of NHL patients. These physicians generally are concentrated in large metropolitan areas. Because of the characteristics of Bexxar, the target physician must have access to a facility with radiopharmaceutical and gamma count capabilities. The Company believes such facilities are available in large metropolitan areas such that a significant portion of physicians who treat NHL patients will be able to prescribe Bexxar. The Company intends to distribute its products internationally through marketing partners. In December 1998, the Company entered into an agreement with SB to jointly commercialize Bexxar. The two companies will co-promote Bexxar in the United States following regulatory approval, with each company fielding its own sales force and both companies sharing profits equally. Outside the United States, excluding Japan, the Company has granted SB exclusive marketing and distribution rights in return for milestone payments and product royalties. The current purchasers of cancer therapeutics are hospitals, clinics, physicians, pharmacies, large HMOs and state and federal governments. Historically, physicians made treatment decisions and prescribed 16 17 therapeutics which then were dispensed through the clinic, hospital or pharmacy. However, the United States health care system is undergoing significant changes and the decision-making authority of the physician varies. These changes may make it necessary for the Company to alter its marketing strategy prior to the launch of Bexxar or even after launch and could affect adversely the ability of the Company to generate revenues. The Company's ability to market effectively may be affected adversely by a number of factors including physicians' resistance to change from established methods of treatment such as chemotherapy or radiation therapy and the special handling and administration requirements of a radioimmunotherapy. Further, the Company can provide no assurance as to whether Bexxar will be priced competitively compared to existing methods of treatment such as chemotherapy and radiation therapy. See "Risk Factors -- Uncertainty of Market Acceptance of Bexxar." PHARMACEUTICAL PRICING AND REIMBURSEMENT Political, economic and regulatory influences are subjecting the health care industry in the United States to fundamental change. Initiatives to reduce the federal deficit and to reform health care delivery are increasing cost-containment efforts. The Company anticipates that Congress, state legislatures and the private sector will continue to review and assess alternative benefits, controls on health care spending through limitations on the growth of private health insurance premiums and Medicare and Medicaid spending, the creation of large insurance purchasing groups, price controls on pharmaceuticals and other fundamental changes to the health care delivery system. Any such proposed or actual changes could cause the Company to limit or eliminate spending on development projects and affect the Company's ultimate profitability. Legislative debate is expected to continue in the future, and market forces are expected to drive reductions of health care costs. The Company cannot predict what impact that adoption of any federal or state health care reform measures or future private sector reforms may have on its business. In both domestic and foreign markets, sales of the Company's proposed products will depend in part upon the availability of reimbursement from third-party payors, such as government health administration authorities, managed care providers, private health insurers and other organizations. In addition, other third-party payors increasingly are challenging the price and cost effectiveness of medical products and services. Significant uncertainty exists as to the reimbursement status of newly approved health care products. Bexxar, as potentially the first radioimmunotherapy for cancer, faces particular uncertainties due to the absence of a comparable, approved therapy to serve as a model for pricing and reimbursement decisions. There can be no assurance that the Company's product candidates will be considered cost effective or that adequate third-party reimbursement will be available to enable the Company to maintain price levels sufficient to realize an appropriate return on its investment in product development. Further, there can be no assurance that products can be manufactured on a commercial scale at a cost that will enable the Company to price its products within reimbursable rates. Legislation and regulations affecting the pricing of pharmaceuticals may change before the Company's proposed products are approved for marketing. Adoption of such legislation could further limit reimbursement for medical products. If adequate coverage and reimbursement rates are not provided by the government and third-party payors for the Company's products, the market acceptance of these products would be adversely affected, which would have a material adverse effect on the Company's business, financial condition and results of operations. GOVERNMENT REGULATION The testing, manufacturing, labeling, advertising, promotion, export and marketing, among other things, of the Company's proposed products are subject to extensive regulation by governmental authorities in the United States and other countries. In the United States, pharmaceutical products are regulated by the FDA under the Federal Food, Drug and Cosmetic Act and other laws, including, in the case of biologics, the Public Health Service Act. At the present time, the Company believes that Bexxar and other immunotherapeutics that it may develop will be regulated by the FDA as biologics and that other products to be developed by the Company, including Super-Leu-Dox and other TAP pro-drugs, are likely to be regulated as drugs. 17 18 The steps required before a drug or biologic may be approved for marketing in the United States generally include (i) preclinical laboratory tests and animal tests, (ii) the submission to the FDA of an IND for human clinical testing, which must become effective before human clinical trials may commence, (iii) adequate and well-controlled human clinical trials to establish the safety and efficacy of the product, (iv) in the case of a biologic, the submission to the FDA of a BLA, or in the case of a drug, a New Drug Application ("NDA"), (v) FDA review of the BLA (or PLA/ELA) or NDA and (vi) satisfactory completion of an FDA inspection of the manufacturing facilities at which the product is made to assess compliance with Good Manufacturing Practices ("GMP"). The testing and approval process requires substantial time, effort and financial resources, and there can be no assurance that any approval will be granted on a timely basis, if at all. Preclinical studies include laboratory evaluation of the product, as well as animal studies to assess the potential safety and efficacy of the product. The results of the preclinical studies, together with manufacturing information and analytical data, are submitted to the FDA as part of the IND, which must become effective before clinical trials may be commenced. The IND automatically will become effective thirty days after receipt by the FDA, unless the FDA before that time raises concerns or questions about the conduct of the trials as outlined in the IND. In such case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can proceed. There can be no assurance that submission of an IND will result in FDA authorization to commence clinical trials. Clinical trials involve the administration of the investigational products to healthy volunteers or patients under the supervision of a qualified principal investigator. Further, each clinical trial must be reviewed and approved by an independent Institutional Review Board ("IRB") at each institution at which the study will be conducted. The IRB will consider, among other things, ethical factors, the safety of human subjects and the possible liability of the institution. Clinical trials typically are conducted in three sequential phases, but the phases may overlap. In Phase I, the initial introduction of the drug into human subjects, the drug is usually tested for safety (adverse effects), dosage tolerance, absorption, metabolism, distribution, excretion and pharmacodynamics. Phase II clinical trials usually involve studies in a limited patient population to (i) evaluate the efficacy of the drug for specific, targeted indications, (ii) determine dosage tolerance and optimal dosage and (iii) identify possible adverse effects and safety risks. Phase III clinical trials generally further evaluate clinical efficacy and test further for safety within an expanded patient population and at multiple clinical sites. Phase IV clinical trials are conducted after approval to gain additional experience from the treatment of patients in the intended therapeutic indication and to document a clinical benefit in the case of drugs approved under accelerated approval regulations. If the FDA approves a product while a company has ongoing clinical trials that were not necessary for approval, a company may be able to use the data from these clinical trials to meet all or part of any Phase IV clinical trial requirement. These clinical trials are often referred to as "Phase III/IV post-approval clinical trials." Failure to conduct promptly Phase IV clinical trials could result in withdrawal of approval for products approved under accelerated approval regulations. In the case of products for severe or life-threatening diseases, the initial clinical trials are sometimes done in patients rather than in healthy volunteers. Since these patients are afflicted already with the target disease, it is possible that such clinical trials may provide evidence of efficacy traditionally obtained in Phase II clinical trials. These trials are referred to frequently as Phase I/II trials. There can be no assurance that Phase I, Phase II or Phase III testing will be completed successfully within any specific time period, if at all, with respect to any of the Company's product candidates. Furthermore, the FDA may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. The results of the preclinical studies and clinical trials, together with detailed information on the manufacture and composition of the product, are submitted to the FDA in the form of a BLA or NDA requesting approval to market the product. Before approving a BLA or NDA, the FDA will inspect the facilities at which the product is manufactured and will not approve the product unless the manufacturing facility complies with GMP. The FDA may delay approval of a BLA or NDA if applicable regulatory criteria 18 19 are not satisfied, require additional testing or information, and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product. There can be no assurance that FDA approval of any BLA or NDA submitted by the Company will be granted on a timely basis, if at all. Also, if regulatory approval of a product is granted, such approval may entail limitations on the indicated uses for which such product may be marketed. The Company also will be subject to a variety of foreign regulations governing clinical trials and sales of its products. Whether or not FDA approval has been obtained, approval of a product by the comparable regulatory authorities of foreign countries must be obtained prior to the commencement of marketing of the product in those countries. The approval process varies from country to country and the time needed to secure approval may be longer or shorter than that required for FDA approval. FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997 In September 1998, the Company submitted a request to the FDA for the designation of Bexxar (for the treatment of patients with relapsed or refractory low-grade NHL) as a Fast Track product. The Fast Track designation means that the FDA will take such actions as are appropriate to expedite the development and review of the license for approval. In December 1998, the Company announced that it was notified by the FDA that Bexxar met the criteria for Fast Track designation. The designation was awarded because one of the targeted indications for the therapy is transformed, low-grade NHL, a life-threatening unmet medical need. ORPHAN DRUG DESIGNATION Under the Orphan Drug Act and the Orphan Drug Amendments of 1998, the FDA may grant orphan drug designation to drugs intended to treat a "rare disease or condition," which is generally a disease or condition that affects fewer than 200,000 individuals in the United States. Orphan drug designation must be requested before submitting a BLA. After the FDA grants orphan drug designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. If a product that has orphan drug designation subsequently receives FDA approval for the indication for which it has such designation, the product is entitled to orphan exclusivity, i.e., the FDA may not approve any other applications to market the same drug for the same indication, except in very limited circumstances, for seven years. Bexxar received orphan drug designation from the FDA in May 1994. Although the FDA recently decided to remove NHL from the list of diseases for which orphan drug designation may be obtained, the previous designation of Bexxar will not be affected. In any event, there can be no assurance that competitors will not receive approval of other, different drugs or biologics for low-grade NHL. Thus, although obtaining FDA approval to market a product with orphan drug exclusivity can be advantageous, there can be no assurance that it would provide the Company with a material commercial benefit. RADIOACTIVE AND OTHER HAZARDOUS MATERIALS The manufacturing and administration of Bexxar requires the handling, use and disposal of (131)I, a radioactive isotope of iodine. These activities must comply with various state and federal regulations, regarding the handling, use and disposal of radioactive materials. Violations of these regulations could significantly delay completion of clinical trials and commercialization of Bexxar. For its ongoing clinical trials and for commercial-scale production, the Company relies on Nordion to radiolabel the Anti-B1 Antibody with (131)I at a single location in Canada. Violations of safety regulations could occur and the risk of accidental contamination or injury cannot be eliminated completely. In the event of any such noncompliance or accident, the supply of radiolabeled Anti-B1 Antibody for use in clinical trials or commercially could be interrupted, which could have a material adverse effect on the Company's business, financial condition and results of operations. See "-- Manufacturing." The administration of Bexxar entails the introduction of radioactive materials into patients. These patients emit radioactivity at levels that may pose a safety concern to others around them, especially healthcare workers for whom the cumulative effect of repeated exposure to radioactivity is of particular 19 20 concern. These concerns are addressed in regulations promulgated by the NRC, as well as by various state and local governments and individual hospitals. Generally, patients who emit radioactivity above specified levels are required to be admitted to the hospital, where they can be isolated from others until radiation falls to approved levels. The NRC recently modified its regulations to make it easier for hospitals to treat patients with radioactive materials on an outpatient basis. Under these modified regulations, Bexxar may be administered on an outpatient basis in most cases. Although state and local governments often follow the lead of the NRC, many currently do not, and there can be no assurance that they will do so or that patients receiving Bexxar will not have to remain in the hospital for one to four days following administration of the therapeutic dose, adding to the overall cost of the therapy. The Company also expects to use hazardous chemicals and radioactive compounds in its ongoing research activities. Although the Company believes that safety procedures for handling and disposing of such materials will comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. The Company could be held liable for any damages that result from such an accident, as well as for unexpected remedial costs and penalties that may result from any violation of applicable regulations, which could result in a material adverse effect on the Company's business, financial condition and results of operations. In addition, the Company may incur substantial costs to comply with environmental regulations. PATENTS AND OTHER INTELLECTUAL PROPERTY The Company believes that patent and trade secret protection is important to its business and that its future will depend in part on its ability to maintain its technology licenses, protect its trade secrets, secure additional patents and operate without infringing the proprietary rights of others. The Company currently holds exclusive rights to two issued United States patent and several patent applications that relate to the Bexxar therapeutic protocol. The Company also holds exclusive rights to a United States patent application relating to the manufacture of Bexxar and to several patent applications relating to the dosimetry methods employed in the administration of Bexxar. The Company also holds an exclusive license to patent applications filed in the United States and Europe relating to its TAP pro-drug program. The pharmaceutical and biotechnology fields are characterized by a large number of patent filings. A substantial number of patents have already been issued to other pharmaceutical and biotechnology companies. Research has been conducted for many years in the monoclonal antibody field by pharmaceutical and biotechnology companies and other organizations. Competitors may have filed applications for or have been issued patents and may obtain additional patents and proprietary rights related to products or processes competitive with or similar to those of the Company. Patent applications are maintained in secrecy for a period after filing. Publication of discoveries in the scientific or patent literature tends to lag behind actual discoveries and the filing of related patent applications. The Company may not be aware of all of the patents potentially adverse to the Company's interest that may have been issued to other companies, research or academic institutions, or others. No assurances can be given that such patents do not exist, have not been filed, or could not be filed or issued, which contain claims relating to the Company's technology, products or processes. To date, no consistent policy has emerged regarding the breadth of claims allowed in pharmaceutical and biotechnology patents. If patents have been or are issued to others containing preclusive or conflicting claims and such claims are ultimately determined to be valid, the Company may be required to obtain licenses to one or more of such patents or to develop or obtain alternative technology. The Company is aware of various patents that have been issued to others that pertain to a portion of the Company's prospective business; however, the Company believes that it does not infringe any patents that ultimately would be determined to be valid. There can be no assurance that patents do not exist in the United States or in other foreign countries or that patents will not be issued to third parties that contain preclusive or conflicting claims with respect to Bexxar or any of the Company's other product candidates or programs. Commercialization of monoclonal antibody-based products may require licensing and/or cross-licensing of one or more patents with other organizations in the field. There can be no assurance that the licenses that might be required for the Company's processes or products would be available on commercially acceptable terms, if at all. 20 21 The Company's breach of an existing license or failure to obtain a license to technology required to commercialize its product candidates may have a material adverse effect on the Company's business, financial condition and results of operations. Litigation, which could result in substantial costs to the Company, may also be necessary to enforce any patents issued to the Company or to determine the scope and validity of third-party proprietary rights. If competitors of the Company prepare and file patent applications in the United States that claim technology also claimed by the Company, the Company may have to participate in interference proceedings declared by the United States Patent and Trademark Office to determine priority of invention, which could result in substantial cost to the Company, even if the eventual outcome is favorable to the Company. An adverse outcome could subject the Company to significant liabilities to third parties and require the Company to license disputed rights from third parties or to cease using such technology. The Company also relies on trade secrets to protect its technology, especially where patent protection is not believed to be appropriate or obtainable. The Company protects its proprietary technology and processes, in part, by confidentiality agreements with its employees, consultants, advisory board members, collaborators and certain contractors. There can be no assurance that these agreements will not be breached, that the Company would have adequate remedies for any breach, or that the Company's trade secrets or those of its collaborators or contractors will not otherwise become known or be discovered independently by competitors. Patents issued and patent applications filed internationally relating to biologics are numerous and there can be no assurance that current and potential competitors and other third parties have not filed or in the future will not file applications for, or have not received or in the future will not receive, patents or obtain additional proprietary rights relating to products or processes used or proposed to be used by the Company. Moreover, there is certain subject matter which is patentable in the United States and not generally patentable outside of the United States. Statutory differences in patentable subject matter may limit the protection the Company can obtain on some of its inventions outside of the United States. For example, methods of treating humans are not patentable in many countries outside of the United States. These and/or other issues may prevent the Company from obtaining patent protection outside of the United States which would have a material adverse effect on the Company's business, financial condition and results of operations. Rights to use the name "Coulter Pharmaceutical, Inc." are licensed from Beckman Coulter. The rights expire on October 31, 2002 or earlier upon the occurrence of certain events. COMPETITION The pharmaceutical and biotechnology industries are intensely competitive. Any product candidate developed by the Company would compete with existing drugs and therapies. There are many pharmaceutical companies, biotechnology companies, public and private universities and research organizations actively engaged in research and development of products for the treatment of people with cancer. Many of these organizations have financial, technical, manufacturing and marketing resources greater than those of the Company. Several of them have developed or are developing therapies that could be used for treatment of the same diseases targeted by the Company. One competitor known to the Company has received approval from the FDA for a non-radiolabeled chimeric antibody for the treatment of low-grade NHL. If a competing company were to develop or acquire rights to a more efficient or safer cancer therapy for treatment of the same diseases targeted by the Company, or one which offers significantly lower costs of treatment, the Company's business, financial condition and results of operations could be materially adversely affected. The Company believes that competition in the development and marketing of new cancer therapies will be based primarily on product efficacy and safety, time to market and price. To the extent the Company's product programs are successful, it also intends to rely to some degree on patents and other intellectual property and orphan drug designations to protect its products from competition. The Company believes that its product development programs will be subject to significant competition from companies utilizing alternative technologies as well as to increasing competition from companies that develop and apply technologies similar to the Company's technologies. Other companies may succeed in developing products earlier than the Company, obtaining approvals for such products from the FDA more rapidly than the Company or developing products that are safer, more effective and/or more cost effective 21 22 than those under development or proposed to be developed by the Company. There can be no assurance that research and development by others will not render the Company's technology or potential products obsolete or non-competitive or result in treatments superior to any therapy developed by the Company, or that any therapy developed by the Company will be preferred to any existing or newly developed technologies. PRODUCT LIABILITY AND INSURANCE The manufacture and sale of human therapeutic products involve an inherent risk of product liability claims and associated adverse publicity. The Company has only limited product liability insurance for clinical trials and no commercial product liability insurance. There can be no assurance that the Company will be able to maintain existing insurance or obtain additional product liability insurance on acceptable terms or with adequate coverage against potential liabilities. Such insurance may be expensive, difficult to obtain and may not be available in the future on acceptable terms, if at all. An inability to obtain sufficient insurance coverage on reasonable terms or to otherwise protect against potential product liability claims brought against the Company in excess of its insurance coverage, if any, or a product recall could have a material adverse effect upon the Company's business, financial condition and results of operations. HUMAN RESOURCES As of December 31, 1998 the Company had 137 employees, 77 of whom were engaged in product development activities. Fifty-one employees hold post-graduate degrees, including five with medical degrees and twenty-one with Ph.D.s. The Company's employees are not represented by a collective bargaining agreement. The Company believes its relations with its employees are good. SCIENTIFIC ADVISORY BOARD James O. Armitage, M.D., is Chairman of the Department of Internal Medicine at the University of Nebraska Medical Center. He previously directed the Bone Marrow Transplant Program at the University of Iowa, where he was an Assistant Professor of Medicine. Paul P. Carbone, M.D., MACP, D.Sc. (Hon.), is the Director of the University of Wisconsin Comprehensive Cancer Center. He also is Professor Emeritus of Medicine and Associate Dean for Program Development at the University of Wisconsin Medical School. He previously served as a physician scientist at the National Institutes of Health. His clinical research has included the development of active combination chemotherapy for Hodgkin's disease, NHL and breast cancer. Lawrence H. Einhorn, M.D., is Distinguished Professor of Medicine at Indiana University Medical Center. His research of germ cell tumors focused upon the discovery of treatments for testicular and ovarian cancer. Dr. Einhorn's work has also been directed toward the optimization of combination chemotherapy for these cancers. Sandra J. Horning, M.D., is Professor of Medicine (Oncology and Bone Marrow Transplantation) at Stanford University School of Medicine. She has been an active member of the American Society of Clinical Oncology since 1983. Dr. Horning's research has focused in the areas of Hodgkin's disease and lymphomas. T. Andrew Lister, is Professor of Medical Oncology at St. Bartholomew's Hospital in London, England where he is also director of the medical oncology unit. Professor Lister is also Honorary Consultant Physician at Broomfield Hospital in Chelmsford, England. He is author of numerous scientific articles on lymphomas and its clinical treatment. Robert J. Mayer, M.D., is the President of the American Society of Clinical Oncology, Chief of the Division of Clinical Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. He also is an attending physician at The Brigham and Women's Hospital, The Massachusetts General Hospital and the Beth Israel/Deaconess Medical Center. Dr. Mayer is known for his work in the treatment of leukemia and gastrointestinal cancers and for developing programs to train cancer researchers and clinicians. Saul Rosenberg, M.D., MACP, is Professor of Medicine and Radiology Emeritus at Stanford University School of Medicine and is an oncologist known for his contributions to advances in the treatment of Hodgkin's disease. 22 23 RISK FACTORS In this Section, the Company summarizes certain risks that should be considered by stockholders and prospective investors in the Company. These risks are discussed in greater detail below, and are discussed in context in other Sections of this Report. Uncertainties Related to Product Development. The Company's product candidates are generally in early stages of development, with only one in clinical trials. The development of safe and effective therapies for the treatment of people with cancer is highly uncertain and subject to numerous risks. Product candidates that may appear to be promising at early stages of development may not reach the market for a number of reasons. Product candidates may be found ineffective or cause harmful side effects during clinical trials, may take longer to progress through clinical trials than had been anticipated, may fail to receive necessary regulatory approvals, may prove impracticable to manufacture in commercial quantities at reasonable cost and with acceptable quality or may fail to achieve market acceptance. The results of initial preclinical and clinical testing of the products under development by the Company are not necessarily indicative of results that will be obtained from subsequent or more extensive preclinical studies and clinical testing. The Company's clinical data gathered to date with respect to Bexxar are from a Phase I/II dose escalation trial which was designed to develop and refine the therapeutic protocol, to determine the maximum tolerated dose of total body radiation and to assess the safety and efficacy profile of treatment with a radiolabeled antibody. Further, the data from this Phase I/II dose escalation trial were compiled from testing conducted at a single site and with a relatively small number of patients per NHL histology and disease stage. The Company has since completed a multi-center Phase II dosimetry clinical trial and a multi-center pivotal Phase III clinical trial. However, substantial additional development, clinical testing and investment may be required prior to seeking any regulatory approval for commercialization of this potential product. There can be no assurance that clinical trials of Bexxar or other product candidates under development will demonstrate the safety and efficacy of such products to the extent necessary to obtain regulatory approvals for the indications being studied, or at all. Companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials, even after obtaining promising results in earlier trials. The failure to demonstrate adequately the safety and efficacy of Bexxar or any other therapeutic product under development could delay or prevent regulatory approval of the product and would have a material adverse effect on the Company's business, financial condition and results of operations. Furthermore, the timing and completion of current and planned clinical trials of Bexxar, as well as clinical trials of other products, are dependent upon, among other factors, the rate at which patients are enrolled, which is a function of many factors, including the size of the patient population, the proximity of patients to the clinical sites, the number of clinical sites, the eligibility criteria for the study and the existence of competing clinical trials. There can be no assurance that delays in patient enrollment in clinical trials will not occur, and any such delays may result in increased costs, program delays or both, which could have a material adverse effect on the Company's business, financial condition and results of operations. Uncertainty of Market Acceptance of Bexxar. Even if the Company's product candidates are approved for marketing by the FDA and other regulatory authorities, there can be no assurance that the Company's products will be commercially successful. If the Company's most advanced product candidate, Bexxar, is approved, it would represent a significant departure from currently approved methods of treatment for NHL and would require the handling of radioactive materials. Accordingly, Bexxar may experience under-utilization by oncologists and hematologists who are unfamiliar with the application of Bexxar in the treatment of NHL. Further, oncologists and hematologists are not typically licensed to administer radioimmunotherapies such as Bexxar and will need to engage a nuclear medicine physician or receive specialty training to administer Bexxar. Recently enacted NRC regulations permit Bexxar to be administered on an outpatient basis in most cases as is currently contemplated by the Company. However, market acceptance could be affected adversely because some hospitals may be required to administer the therapeutic dose of Bexxar on an inpatient basis under applicable state or local or individual hospital regulations. As with any new drug, doctors may be inclined to continue to treat patients with conventional therapies, in this case chemotherapy. Market 23 24 acceptance also could be affected by the availability of third-party reimbursement. Failure of Bexxar to achieve significant market acceptance would have a material adverse effect on the Company's business, financial condition and results of operations. See "-- Uncertainty Related to Health Care Reform and Third-Party Reimbursement," "-- Hazardous and Radioactive Materials," and "Business -- Radioactive and Other Hazardous Materials." Early Stage of Development. Since its inception in 1995, the Company has been engaged in the development of drugs and related therapies for the treatment of people with cancer. The Company's product candidates are generally in early stages of development, with only one in clinical trials. No revenues have been generated from product sales or product royalties; and there can be no assurance that products resulting from the Company's research and development efforts will be available within a specific timeframe. No assurance can be given that the Company's product development efforts, including clinical trials, will be successful, that required regulatory approvals for the indications being studied can be obtained, that its products can be manufactured at acceptable cost and with appropriate quality or that any approved products can be successfully marketed. See "Management's Discussion and Analysis of Financial Condition and Results of Operations." Government Regulation; No Assurance of Regulatory Approvals. All new drugs and biologics, including the Company's products under development, are subject to extensive and rigorous regulation by the federal government, principally the FDA under the Food, Drug and Cosmetic Act and other laws including, in the case of biologics, the Public Health Services Act, in the case of radioactive products, the NRC; and by state and local governments. Such regulations govern, among other things, the development, testing, manufacture, labeling, storage, premarket approval, criteria for release of patents relating to administration of radioactive materials, advertising, promotion, sale and distribution, and postmarketing surveillance of such products. If drug products are marketed abroad, they also are subject to extensive regulation by foreign governments. The regulatory process, which includes physicochemical studies, preclinical studies and clinical trials of each potential product, is lengthy, expensive and uncertain. Prior to commercial sale in the United States, most new drugs and biologics, including the Company's products under development, must be approved by the FDA. Securing FDA marketing approvals often requires the submission of extensive, physicochemical preclinical and clinical data and supporting information to the FDA. Product approvals, if granted, can be withdrawn for failure to comply with regulatory requirements or upon the occurrence of unforeseen problems following initial marketing. Moreover, regulatory approvals for products such as new drugs and biologics, even if granted, may include significant limitations on the uses for which such products may be marketed. There can be no assurance that the Company will be able to obtain necessary regulatory approvals on a timely basis, if at all, for any of its product candidates, and delays in receipt or failures to receive such approvals or failures to comply with existing or future regulatory requirements could have a material adverse effect on the Company's business, financial condition and results of operations. Certain material manufacturing changes to new drugs and biologics also are subject to FDA review and approval. There can be no assurance that any approvals that are required, once obtained, will not be withdrawn or that compliance with other regulatory requirements can be maintained. Further, failure to comply with applicable FDA and other regulatory requirements can result in sanctions being imposed on the Company or the manufacturers of its products, including warning letters, fines, product recalls or seizures, injunctions, refusals to permit products to be imported into or exported out of the United States, refusals of the FDA to grant premarket approval of drugs and biologics or to allow the Company to enter into government supply contracts, withdrawals of previously approved marketing applications and criminal prosecutions. Manufacturers of drugs and biologics also are required to comply with the applicable FDA GMP regulations, which include requirements relating to quality control and quality assurance as well as the corresponding maintenance of records and documentation. Manufacturing facilities are subject to inspection by the FDA, including unannounced inspection, and must be licensed before they can be used in commercial manufacturing of the Company's products. The Company relies on Nordion for centralized radiolabeling of the Anti-B1 Antibody at Nordion's radiolabeling facility in Canada. To the Company's knowledge, Nordion's radiolabeling facilities previously have not been licensed by the FDA as suitable for commercial manufactur- 24 25 ing of a drug or biologic. There can be no assurance that the Company or its suppliers will be able to comply with the applicable GMP regulations and other FDA regulatory requirements. Such failure could have a material adverse effect on the Company's business, financial condition and results of operations. In December 1998, the Company announced that it had been notified by the FDA that Bexxar met the criteria for Fast Track designation because one of the targeted indications is transformed low-grade NHL, a life-threatening unmet medical need. However, significant uncertainty exists as to the extent to which Bexxar's Fast Track designation will result in expedited review and approval. Further, the FDA retains considerable discretion to determine eligibility for a priority review and approval and is not bound by discussions that an applicant may have had with FDA staff. Accordingly, the FDA could employ such discretion to deny eligibility of Bexxar as a candidate for a priority review or to require additional clinical trials or other information before approving Bexxar. A determination that Bexxar is not eligible for a priority review or delays and additional expenses associated with generating a response to any such request for additional trials could have a material adverse effect on the Company's business, financial condition and results of operations. See "Business -- Government Regulation." Dependence on Suppliers; Manufacturing and Scale-up Risk. The Company has no existing internal capacity or experience with respect to manufacturing products for large-scale clinical trials or commercial purposes. The Company has contracted with two third-party manufacturers, Lonza and BI Pharma KG to produce unlabeled Anti-B1 Antibody and with Cytogen for filling and labeling. There can be no assurance that any Anti-B1 antibody produced by BI Pharma will be deemed clinically equivalent to Anti-B1 antibody produced by Lonza, which equivalence is a prerequisite to clinical and commercial use of any Anti-B1 antibody produced by BI Pharma. In addition, these manufacturers have limited experience producing the Anti-B1 Antibody, and there can be no assurance that they will be able to produce the Company's requirements in commercial quantities or with acceptable quality. The Company relies upon Nordion for radiolabeling of the Anti-B1 Antibody at Nordion's centralized radiolabeling facility. The Company and Nordion have entered into an agreement for supply of the radiolabeled Anti-B1 Antibody for both clinical trials and commercial sale. If Bexxar is approved and is successful in the market, there can be no assurance that Nordion's capacity to radiolabel antibodies is sufficient to meet all of the Company's commercial requirements. The Company is aware of only a limited number of manufacturers capable of producing the Anti-B1 Antibody in commercial quantities or radiolabeling the antibody with (131)I on a commercial scale. To establish and qualify a new facility to centrally radiolabel antibodies could take as long as two years. Further, radiolabeled antibody cannot be stockpiled against future shortages due to the eight-day half-life of the 131)I radioisotope. Accordingly, any change in the Company's existing contractual relationships with, or interruption in supply from, its producer of unlabeled antibody or its radiolabeler could affect adversely the Company's ability to complete its ongoing clinical trials and to market Bexxar, if approved. Any such change or interruption would have a material adverse effect on the Company's business, financial condition and results of operations. Although the Company is evaluating additional sources of supply for production and radiolabeling of the Anti-B1 Antibody, no assurance can be given that such sources will be secured on commercially reasonable terms, on a timely basis, or at all. Prior to August 1997, the Company obtained Anti-B1 Antibody from an inventory produced by Beckman Coulter, and radiolabeling was performed by radiopharmacies at the individual clinical trial sites. In order to begin using Lonza Anti-B1 Antibody, BI Pharma KG Anti-B1 Antibody, and the centrally radiolabeled Anti-B1 Antibody from Nordion, the Company filed and the FDA cleared IND amendments to allow the use of these materials in clinical trials. The Company is collecting data from its clinical trials to be filed with the FDA to establish that Anti-B1 Antibody from these different sources and that Nordion radiolabeled and on-site radiolabeled Anti-B1 antibody are clinically comparable. However, there can be no assurance that it will be able to establish clinical comparability. A failure to establish clinical comparability could lead to a requirement that the Company conduct additional clinical trials, which would increase costs and potentially delay regulatory approval for Bexxar. 25 26 Third-party manufacturers must comply with GMP regulations prescribed by the FDA and other standards prescribed by various federal, state and local regulatory agencies in the United States and any other relevant country. Failure to comply with these regulations could have a material adverse effect on the Company's business, financial condition and results of operations. Absence of Commercialization Resources and Experience; Reliance on Marketing Partner. The Company intends to market and sell Bexxar in the United States through a direct sales force and in collaboration with SB, and internationally (except Japan) through SB. The Company currently does not possess the resources and experience necessary to commercialize any of its product candidates. The Company's ability to market Bexxar, if approved, will be contingent upon recruitment, training and deployment of a sales and marketing force as well as the performance of SB under the collaboration agreement. Development of an effective sales force will require significant financial resources and time. There can be no assurance that the Company will be able to establish such a sales force in a timely or cost effective manner, if at all, or that such a sales force will be capable of generating demand for Bexxar or other product candidates. Failure to establish such a sales force and marketing capability could have a material adverse effect on the Company's business, financial condition and results of operations. Highly Competitive Industry; Risk of Technological Obsolescence. The pharmaceutical and biotechnology industries are intensely competitive. Any product candidate developed by the Company would compete with existing drugs and therapies. There are many pharmaceutical companies, biotechnology companies, public and private universities and research organizations actively engaged in research and development of products for the treatment of people with cancer. Many of these organizations have financial, technical, manufacturing and marketing resources greater than those of the Company. Several of them may have developed or are developing therapies that could be used for treatment of the same diseases targeted by the Company. One competitor known to the Company recently received a approval from the FDA of its non-radiolabeled chimeric antibody for the treatment of low-grade NHL. If a competing company were to develop or acquire rights to a more efficacious or safer cancer therapy for treatment of the same diseases targeted by the Company, or one which offers significantly lower costs of treatment, the Company's business, financial condition and results of operations could be materially adversely affected. The Company believes that its product development programs will be subject to significant competition from companies utilizing alternative technologies as well as to increasing competition from companies that develop and apply technologies similar to the Company's technologies. Other companies may succeed in developing products earlier than the Company, obtaining approvals for such products from the FDA more rapidly than the Company or developing products that are safer and more effective than those under development or proposed to be developed by the Company. There can be no assurance that research and development by others will not render the Company's technology or product candidates obsolete or non-competitive or result in treatments superior to any therapy developed by the Company, or that any therapy developed by the Company will be preferred to any existing or newly developed technologies. Dependence Upon Proprietary Technology; Uncertainty of Patents and Proprietary Technology. The pharmaceutical and biotechnology fields are characterized by a large number of patent filings. A substantial number of patents have already been issued to other pharmaceutical and biotechnology companies. Research has been conducted for many years in the monoclonal antibody field by pharmaceutical and biotechnology companies and other organizations. Competitors may have filed applications for or have been issued patents and may obtain additional patents and proprietary rights related to products or processes competitive with or similar to those of the Company. Patent applications are maintained in secrecy for a period after filing. Publication of discoveries in the scientific or patent literature tends to lag behind actual discoveries and the filing of related patent applications. The Company may not be aware of all of the patents potentially adverse to the Company's interests that may have been issued to other companies, research or academic institutions, or others. No assurance can be given that such patents do not exist, have not been filed, or could not be filed or issued, which contain claims relating to the Company's technology, products or processes. To date, no consistent policy has emerged regarding the breadth of claims allowed in pharmaceutical and biotechnology patents. If patents have been or are issued to others containing preclusive or conflicting claims and such claims are determined ultimately to be valid, the Company may be required to obtain licenses to one 26 27 or more of such patents or to develop or obtain alternative technology. The Company is aware of various patents that have been issued to others that pertain to a portion of the Company's prospective business; however, the Company believes that it does not infringe any patents that ultimately would be determined to be valid. There can be no assurance that patents do not exist in the United States or in other foreign countries or that patents will not be issued to third parties that contain preclusive or conflicting claims with respect to Bexxar or any of the Company's other product candidates or programs. Commercialization of monoclonal antibody-based products may require licensing and/or cross-licensing of one or more patents with other organizations in the field. There can be no assurance that the licenses that might be required for the Company's processes or products would be available on commercially acceptable terms, if at all. The Company's breach of an existing license or failure to obtain a license to technology required to commercialize its product candidates may have a material adverse effect on the Company's business, financial condition and results of operations. Litigation, which could result in substantial costs to the Company, may also be necessary to enforce any patents issued to the Company or to determine the scope and validity of third-party proprietary rights. If competitors of the Company prepare and file patent applications in the United States that claim technology also claimed by the Company, the Company may have to participate in interference proceedings declared by the United States Patent and Trademark Office to determine priority of invention, which could result in substantial cost to the Company, even if the eventual outcome is favorable to the Company. An adverse outcome could subject the Company to significant liabilities to third parties and require the Company to license disputed rights from third parties or to cease using such technology. The Company also relies on trade secrets to protect its technology, especially where patent protection is not believed to be appropriate or obtainable. The Company protects its proprietary technology and processes, in part, by confidentiality agreements with its employees, consultants, advisory board members, collaborators and certain contractors. There can be no assurance that these agreements will not be breached, that the Company would have adequate remedies for any breach, or that the Company's trade secrets or those of its collaborators or contractors will not otherwise become known or be discovered independently by competitors. Patents issued and patent applications filed internationally relating to biologics are numerous and there can be no assurance that current and potential competitors and other third parties have not filed or in the future will not file applications for, or have not received or in the future will not receive, patents or obtain additional proprietary rights relating to products or processes used or proposed to be used by the Company. Moreover, there is certain subject matter which is patentable in the United States and not generally patentable outside of the United States. Statutory differences in patentable subject matter may limit the protection the Company can obtain on some of its inventions outside of the United States. For example, methods of treating humans are not patentable in many countries outside of the United States. These and/or other issues may prevent the Company from obtaining patent protection outside of the United States which would have a material adverse effect on the Company's business, financial condition and results of operations. See "Business -- Patents and Other Intellectual Property." Future Capital Needs; Uncertainty of Additional Funding. The Company's operations to date have consumed substantial and increasing amounts of cash. The negative cash flow from operations is expected to continue and to accelerate in next several years. The development of the Company's technology and potential products will require a commitment of substantial funds. The Company expects that its existing capital resources will be adequate to satisfy the requirements of its current and planned operations through 2000. However, the rate at which the Company expends its resources is variable, may be accelerated and will depend on many factors, including the scope and results of preclinical studies and clinical trials, the cost, timing and outcome of regulatory approvals, continued progress of the Company's research and development of product candidates, the timing and cost of establishment or procurement of requisite production radiolabeling and other manufacturing capacities, the cost involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, the expenses of establishing a sales and marketing force, the acquisition of technology licenses, the status of competitive products and the availability of other financing. The Company may need to raise substantial additional capital to fund its operations and, if needed, intends to seek such additional funding through public or private equity or debt financings, as well as through 27 28 collaborative arrangements. There can be no assurance that such additional funding will be available on acceptable terms, if at all. If additional funds are raised by issuing equity securities, substantial dilution to stockholders may result. If adequate funds are not available, the Company may be required to delay, reduce the scope of, or eliminate one or more of its research and development programs or obtain funds through arrangements with collaborative partners or others that may require the Company to relinquish rights to certain of its technologies, product candidates or products that the Company would otherwise seek to develop or commercialize. See "Management's Discussion and Analysis of Financial Condition and Results of Operations." History of Operating Losses; Anticipated Future Losses. The Company has a limited history of operations and has experienced significant losses since inception. As of December 31, 1998, the Company's accumulated deficit was approximately $46.6 million. The Company expects to incur significant additional operating losses over the next several years and expects cumulative losses to increase substantially due to expanded research and development efforts, preclinical studies and clinical trials and development of manufacturing, marketing and sales capabilities. The Company expects that losses will fluctuate from quarter to quarter and that such fluctuations may be substantial. All of the Company's product candidates are in development in preclinical studies and clinical trials, and no revenues have been generated from product sales. To achieve and sustain profitable operations, the Company, alone or with others, must develop successfully, obtain regulatory approval for, manufacture, introduce, market and sell its products. The time frame necessary to achieve market success is long and uncertain. The Company does not expect to generate product revenues for at least the next year. There can be no assurance that the Company will ever generate sufficient product revenues to become profitable or to sustain profitability. See "Management's Discussion and Analysis of Financial Condition and Results of Operations." Dependence on Management and Other Key Personnel. The Company is dependent upon a limited number of key management and technical personnel. The loss of the services of one or more of such key employees could have a material adverse effect on the Company's business, financial condition and results of operations. In addition, the Company's success will be dependent upon its ability to attract and retain additional highly qualified sales, management, manufacturing and research and development personnel. The Company faces intense competition in its recruiting activities, and there can be no assurance that the Company will be able to attract and/or retain qualified personnel. Exposure to Product Liability. The manufacture and sale of human therapeutic products involve an inherent risk of product liability claims and associated adverse publicity. The Company has only limited product liability insurance for clinical trials and no commercial product liability insurance. There can be no assurance that the Company will be able to maintain existing insurance or obtain additional product liability insurance on acceptable terms or with adequate coverage against potential liabilities. Such insurance is expensive, may be difficult to obtain and may not be available in the future on acceptable terms, if at all. An inability to obtain sufficient insurance coverage on reasonable terms or to otherwise protect against potential product liability claims brought against the Company in excess of its insurance coverage, if any, or a product recall could have a material adverse effect upon the Company's business, financial condition and results of operations. Uncertainty Related to Health Care Reform and Third-Party Reimbursement. Political, economic and regulatory influences are subjecting the health care industry in the United States to fundamental change. Initiatives to reduce the federal deficit and to reform health care delivery are increasing cost-containment efforts. The Company anticipates that Congress, state legislatures and the private sector will continue to review and assess alternative benefits, controls on health care spending through limitations on the growth of private health insurance premiums and Medicare and Medicaid spending, the creation of large insurance purchasing groups, price controls on pharmaceuticals and other fundamental changes to the health care delivery system. Any such proposed or actual changes could cause the Company to limit or eliminate spending on development projects and affect the Company's ultimate profitability. Legislative debate is expected to continue in the future, and market forces are expected to drive reductions of health care costs. The Company cannot predict what impact the adoption of any federal or state health care reform measures or future private sector reforms may have on its business. 28 29 In both domestic and foreign markets, sales of the Company's proposed products will depend in part upon the availability of reimbursement from third-party payors, such as government health administration authorities, managed care providers, private health insurers and other organizations. Third-party payors are increasingly challenging the price and cost effectiveness of medical products and services. Significant uncertainty exists as to the reimbursement status of newly approved health care products. Bexxar, as potentially the first radioimmunotherapy for cancer, faces particular uncertainties due to the absence of a comparable, approved therapy to serve as a model for pricing and reimbursement decisions. Further, if Bexxar is not administered in most cases on an outpatient basis, as is contemplated currently by the Company, the projected cost of the therapy will be higher than anticipated. In addition, there can be no assurance that products can be manufactured on a commercial scale for a cost that will enable the Company to price its products within reimbursable rates. Consequently, there can be no assurance that the Company's product candidates will be considered cost effective or that adequate third-party reimbursement will be available to enable the Company to maintain price levels sufficient to realize an appropriate return on its investment in product development. If adequate coverage and reimbursement rates are not provided by the government and third-party payors for the Company's products, the market acceptance of these products could be adversely affected, which could have a material adverse effect on the Company's business, financial condition and results of operations. Hazardous and Radioactive Materials. The manufacturing and administration of Bexxar requires the handling, use and disposal of (131)I, a radioactive isotope of iodine. These activities must comply with various state and federal regulations. Violations of these regulations could delay significantly completion of clinical trials and commercialization of Bexxar. For its ongoing clinical trials and for commercial-scale production, the Company relies on Nordion to radiolabel the Anti-B1 Antibody with (131)I at a single location in Canada. Violations of safety regulations could occur with this manufacturer, and, therefore, there is a risk of accidental contamination or injury. In the event of any such noncompliance or accident, the supply of radiolabeled Anti-B1 Antibody for use in clinical trials or commercially could be interrupted, which could have a material adverse effect on the Company's business, financial condition and results of operations. The Company also expects to use hazardous chemicals and radioactive compounds in its ongoing research activities. The Company could be held liable for any damages that result from such an accident, contamination or injury from the handling and disposal of these materials, as well as for unexpected remedial costs and penalties that may result from any violation of applicable regulations, which could result in a material adverse effect on the Company's business, financial condition and results of operations. In addition, the Company may incur substantial costs to comply with environmental regulations. Potential Volatility of Stock Price. The securities markets have from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. The market prices of the common stock of many publicly held biotechnology and pharmaceutical companies have in the past been, and can in the future be expected to be, especially volatile. Announcements of technological innovations or new products by the Company or its competitors, release of reports by securities analysts, sales of stock by large holders, developments or disputes concerning patents or proprietary rights, regulatory developments, changes in regulatory or medical reimbursement policies, economic and other external factors, as well as period-to-period fluctuations in the Company's financial results, may have a significant and adverse impact on the market price of the Common Stock. See "Price Range of Common Stock." Potential Adverse Impact of Shares Eligible for Future Sale. Sales of shares of Common Stock (including shares issued upon the exercise of outstanding options) in the public market could adversely affect the market price of the Common Stock. Such sales also might make it more difficult for the Company to sell equity securities or equity-related securities in the future at a time and price that the Company deems appropriate. Adverse Impact of Possible Issuances of Preferred Stock; Anti-Takeover Effect of Certain Charter and Bylaw Provisions. The Board of Directors has authority to issue up to 3,000,000 shares of Preferred Stock and to fix the price, rights, preferences, privileges and restrictions, including voting rights, of those shares 29 30 without any further vote or action by the stockholders. The rights of the holders of Common Stock will be subject to, and may be adversely affected by, the rights of the holders of any Preferred Stock that may be issued in the future. The issuance of Preferred Stock could affect adversely the voting power of holders of Common Stock and the likelihood that such holders will receive dividend payments and payments upon liquidation. Additionally, the issuance of Preferred Stock may have the effect of delaying, deferring or preventing a change in control of the Company, may discourage bids for the Common Stock at a premium over the market price of the Common Stock and may affect adversely the market price of and the voting and other rights of the holders of the Common Stock. In addition, the Company's Bylaws provide that special meetings of stockholders may be called only by the Chairman of the Board of Directors, the Chief Executive Officer or the Board of Directors pursuant to a resolution approved by a majority of the Board of Directors. In July 1997, the Company adopted a Share Purchase Rights Plan, commonly referred to as a "poison pill." In addition, the Company is subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law, which prohibits the Company from engaging in a "business combination" with an "interested stockholder" for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. These provisions, along with certain provisions of California law that may be applicable to the Company, could have the effect of discouraging certain attempts to acquire the Company which could deprive the Company's stockholders of the opportunity to sell their shares of Common Stock at prices higher than prevailing market prices. 30 31 ITEM 2. PROPERTIES The Company currently leases approximately 77,000 square feet of office space in Palo Alto, Alameda and South San Francisco, California, under several lease agreements. In November 1997, the Company entered into an agreement to build and lease new facilities in South San Francisco, California. The first two buildings are each approximately 50,000 square feet and contain both office and laboratory facilities. The lease includes an option to occupy third building. In February 1999, the Company began vacating the Palo Alto offices and moving substantially all personnel from the Palo Alto space to the first of the two buildings in South San Francisco. The second of these leased buildings is currently under construction. In connection with its lease agreement, the Company obtained a letter of credit agreement from a bank which secures the aggregate future payments under the lease. ITEM 3. LEGAL PROCEEDINGS Not Applicable. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITIES HOLDERS Not Applicable. 31 32 PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON STOCK AND RELATED STOCKHOLDERS MATTERS The Company's Common Stock is traded on The Nasdaq Stock Market(R) under the symbol "CLTR." Trading of the Company's Common Stock commenced on January 28, 1997, following effectiveness of its initial public offering. The following table presents quarterly information on the price range of the Company's Common Stock, indicating the high and low sales prices reported by the Nasdaq Stock Market(R). These prices do not include retail markups, markdowns or commissions.
1998 LOW HIGH ---- ------ ------ First Quarter.............................................. 17.000 28.438 Second Quarter............................................. 21.625 35.125 Third Quarter.............................................. 13.250 32.125 Fourth Quarter............................................. 18.375 34.125
1997 LOW HIGH ---- ------ ------ First Quarter.............................................. 8.750 13.250 Second Quarter............................................. 6.500 12.625 Third Quarter.............................................. 7.875 15.125 Fourth Quarter............................................. 13.000 23.500
As of March 12, 1999, the Company had approximately 377 holders of record of its Common Stock. The Company has never paid any cash dividends on its capital stock and does not expect to pay any such dividends in the foreseeable future. In December 1998, the Company issued to SmithKline Beecham Corporation ("SB"), 239,607 shares of its Common Stock for a purchase price of $7.25 million in connection with the collaboration agreement with SB. The above-listed securities were issued in reliance on an exemption to the registration requirements of the Securities Exchange Act of 1933. 32 33 ITEM 6. SELECTED CONSOLIDATED FINANCIAL DATA The following selected consolidated financial data as of December 31, 1997 and 1998 and for each of the three years in the period ended December 31, 1998 and the period from inception (February 16, 1995) to December 31, 1998 are derived from the consolidated financial statements of Coulter Pharmaceutical, Inc. that have been audited by Ernst & Young LLP, independent auditors, and which are included herein. The selected consolidated financial data as of December 31, 1995 and 1996 and for the period from inception (February 16, 1995) to December 31, 1995 are derived from the consolidated financial statements of Coulter Pharmaceutical, Inc. that have been audited by Ernst & Young LLP, and which are not included herein. The selected consolidated financial data as of December 31, 1994 and for the year ended December 31, 1994 and for the period from January 1, 1995 to February 15, 1995 are derived from the financial statements of the Antibody Therapeutics Business Operations of Coulter Corporation that have been audited by Ernst & Young LLP, and which are not included herein.
FULL YEAR 1995 ------------------------------ ANTIBODY THERAPEUTICS BUSINESS OPERATIONS OF COMPANY COULTER CORPORATION(2) ------------------------------------------------------------------------ ------------------------- INCEPTION INCEPTION YEAR ENDED JAN. 1, 1995 (FEB. 16, 1995) YEAR ENDED YEAR ENDED YEAR ENDED (FEB. 16, 1995) DEC. 31, TO FEB. 15, TO DEC. 31, DEC. 31, DEC. 31, DEC. 31, TO DEC. 31, 1994 1995 1995 1996 1997 1998 1998 ---------- ------------ --------------- ---------- ---------- ---------- --------------- (IN THOUSANDS, EXCEPT PER SHARE DATA) STATEMENTS OF OPERATIONS DATA: Corporate partner revenues................. -- -- -- -- -- $34,250 $ 34,250 Operating expenses: Research and development............ 2,798 200 2,539 13,681 21,045 28,698 65,963 Selling, general and administrative......... 288 36 581 2,409 7,610 11,758 22,358 ------- ----- ----------- -------- -------- ------- -------- Total operating expenses......... 3,086 236 3,120 16,090 28,655 40,456 88,321 Interest income and other, net...................... -- -- 127 752 2,327 4,248 7,454 ------- ----- ----------- -------- -------- ------- -------- Net loss................... $(3,086) $(236) $ (2,993) $(15,338) $(26,328) $(1,958) $(46,617) ======= ===== =========== ======== ======== ======= ======== Basic and diluted net loss per share(1)............. $(12,736.17) $(649.39) $ (2.58) $ (0.13) -- ----------- -------- -------- ------- Shares used in computing basic and diluted net loss per share(1)........ 0.235 24 10,197 14,562 -- ----------- -------- -------- -------
ANTIBODY THERAPEUTICS BUSINESS OPERATIONS OF COMPANY COULTER CORPORATION(2) ----------------------------------------- ---------------------- DEC. 31, DEC. 31, DEC. 31, DEC. 31, DECEMBER 31, 1994 1995 1996 1997 1998 ---------------------- -------- -------- -------- -------- (IN THOUSANDS) BALANCE SHEET DATA: Cash, cash equivalents and short-term investments......................... $ -- $ 3,438 $ 16,443 $ 75,445 $139,778 Working capital (deficit)............. (50) 2,878 10,737 65,202 131,263 Total assets................ 135 3,628 18,321 78,671 153,430 Non-current portion of equipment financing obligations and debt facility............................ -- -- 1,535 2,298 6,659 Deficit accumulated during the development stage................... -- (2,993) (18,331) (44,659) (46,617) Total stockholders' equity.................... -- 2,997 10,546 65,861 135,193 Coulter Corporation(2) net investment.......................... 85 -- -- -- --
- --------------- (1) See Note 1 to the December 31, 1998 financial statements for information regarding the calculation of net loss per share amounts. (2) Coulter Corporation was acquired by Beckman Instruments, Inc. and is now known as Beckman Coulter, Inc. 33 34 ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS OVERVIEW Coulter Pharmaceutical is engaged in the development of novel drugs and therapies for the treatment of people with cancer. The Company currently is developing a family of cancer therapeutics based upon two drug discovery programs: therapeutic antibodies and targeted oncologics. Within these broad discovery programs, the Company is currently concentrating on two distinct platform technologies: therapeutic antibodies based on conjugated antibody technology and targeted oncologics based on tumor activated peptide ("TAP") pro-drugs technology. The Company's most advanced product candidate, Bexxar(TM) (formerly known as the "B-1 Therapy"), consists of a monoclonal antibody conjugated with a radioisotope. The Company intends to seek initial approval of Bexxar for the treatment of low-grade and transformed low-grade non-Hodgkin's lymphoma ("NHL") in patients who have relapsed after, or are refractory to, chemotherapy. The Company intends to seek expedited Biologics License Application ("BLA") review and marketing approval for Bexxar, while simultaneously pursuing clinical trials to expand the potential use of Bexxar to other indications. Bexxar is based upon the antibody therapeutics program which originated at Coulter Corporation. In 1995, Coulter Pharmaceutical was incorporated and acquired worldwide rights to Bexxar and related intellectual property, know-how and other assets from Coulter Corporation. In 1997, Beckman Instruments, Inc. acquired Coulter Corporation, and is now known as Beckman Coulter. In December 1998, the Company announced a joint collaboration agreement with SmithKline Beecham Corporation ("SB") granting them joint marketing rights in the United States and exclusive commercial rights internationally, except Japan. To date, the Company has devoted substantially all of its resources to research and development programs, as well as selling, general and administrative activities needed to support product development and potential product sales. No revenues have been generated from product sales, and product revenues resulting from the Company's research and development efforts will not occur until commercial availability of such product. The Company has a limited history of operations and has experienced significant operating losses to date. The Company may continue to incur significant additional operating losses over the next several years and expects cumulative losses to increase substantially due to expanded research and development efforts, preclinical studies and clinical trials and development of manufacturing, marketing and sales capabilities if product sales revenues do not offset these costs. The Company expects that losses will fluctuate from quarter to quarter and that such fluctuations may be substantial. There can be no assurance that the Company will successfully develop, manufacture and commercialize its products or ever achieve or sustain product revenues or profitability. As of December 31, 1998, the Company's accumulated deficit was approximately $46.6 million. RESULTS OF OPERATIONS COMPARISON OF YEARS ENDED DECEMBER 31, 1998, DECEMBER 31, 1997 AND DECEMBER 31, 1996 Corporate Partner Revenues. Corporate Partner revenues for the year ended December 31, 1998 were $34.3 million compared with zero for the years ended December 31, 1997 and 1996. The 1998 revenue is attributable to the license fee payment received from SB under the joint development and commercialization agreement for Bexxar. This was a one time, non-refundable license fee and provides no indication as to the level of revenue that can be expected in future periods. Revenue in future periods will depend on the achievement of contract milestones and commercial sales of Bexxar. Operating Expenses. Research and development expenses were $28.7 million for the year ended December 31, 1998, compared to $21.0 million for the year ended December 31, 1997 and $13.7 million for the year ended December 31, 1996. The $7.7 million increase from 1997 to 1998 was due primarily to increases in staffing and expenditures associated with the development of Bexxar, including costs of clinical trials and manufacturing expenses. These manufacturing expenses included certain expenses associated with scaled-up production of monoclonal antibodies and the establishment of a centralized radiolabeling capability. The $7.3 million increase from 1996 to 1997 was due primarily to increases in staffing and in expenditures 34 35 associated with the development of Bexxar, including costs of clinical trials and manufacturing expenses. The Company expects its research and development expenses to grow in 1999, reflecting anticipated increased costs related to additions to staffing, preclinical studies, clinical trials and manufacturing. Selling, general and administrative expenses were $11.8 million for the year ended December 31, 1998, compared to $7.6 million for the year ended December 31, 1997 and $2.4 million for the year ended December 31, 1996. The $4.2 million increase from 1997 to 1998 was incurred to support the Company's increased pre-commercialization expenses, as well as facilities and staffing expansion, increased corporate development activities and related legal and patent activities. The $5.2 million increase from 1996 to 1997 was incurred to support the Company's facilities expansion, increased research and development efforts, and related legal and patent activities. The Company expects its selling, general and administrative expenses to continue to increase in 1999 to support its increasing commercialization efforts in anticipation of potential product sales, as well as to support its increased research and development, patent and corporate development activities and facilities expansion. Interest Income and other, net. Interest income was $4.2 million for the year ended December 31, 1998, compared to $2.3 million for the year ended December 31, 1997 and $0.8 million for year ended December 31, 1996. The $1.9 million increase from 1997 to 1998 was due to higher average cash, cash equivalent and short-term investment balances as a result of the Company's follow-on offering of common stock in July 1998 and the proceeds from SB related to the joint development and commercialization agreement for Bexxar. The $1.5 million increase from 1996 to 1997 was due to higher average cash, cash equivalent and short-term investment balances as a result of the Company's initial public offering in January 1997 and follow-on offering of common stock in October 1997. Interest expense is not material for any period presented. LIQUIDITY AND CAPITAL RESOURCES Since its inception through December 31, 1998, the Company has financed its operations primarily through private placements and public offerings of equity securities totaling $179.8 million. In July 1998, the Company completed a follow-on public offering of 2,400,000 shares of common stock at a price to the public of $25.00 per share, resulting in net proceeds to the Company of approximately $56.3 million. Also, in August 1998, the underwriters of that offering purchased 245,000 additional shares of common stock upon a partial exercise of their over-allotment option, raising additional net proceeds of $5.8 million. The total net proceeds from this offering were $62.1 million. In October 1998, the Company entered into a $10.0 million revolving credit line agreement with a bank, $5.0 million of which was available at December 31, 1998. The Company also received $41.5 million (including $7.3 million for the purchase 239,607 shares of the Company's common stock) from SB upon the effectiveness of the joint development and commercialization agreement for Bexxar in December 1998. The SB agreement also provides for a $15 million credit line, all of which was available at December 31, 1998. Cash, cash equivalents and short-term investments totaled $139.8 million at December 31, 1998. The negative cash flow from operations in the years ended December 31, 1996, 1997 and 1998 results primarily from the Company's net operating losses and is expected to continue and to accelerate in next several years. The Company expects to incur substantial and increasing research and development expenses, including expenses related to additions to personnel, preclinical studies, clinical trials, manufacturing and commercialization efforts. The Company may need to raise substantial additional capital to fund its operations. The Company may seek such additional funding through public or private equity or debt financings from time to time, as market conditions permit. There can be no assurance that additional financing will be available on acceptable terms, if at all. If adequate funds are not available, the Company may be required to delay, reduce the scope of, or eliminate one or more of its research and development programs or obtain funds through arrangements with collaborative partners or others that may require the Company to relinquish rights to certain of its technologies, product candidates or products that the Company would otherwise seek to develop or commercialize. Net cash used in operations was $3.2 million for the year ended December 31, 1998, compared to $21.1 million used in the year ended December 31, 1997. This decrease is primarily the result of the decreased 35 36 net loss for the period ended December 31, 1998. Net cash used in investing activities decreased to $2.9 million for the year ended December 31, 1998 from $49.0 million used in the year ended December 31, 1997, primarily resulting from higher maturities and sales of short-term investments. The Company's capital expenditures increased to $7.9 million for the year ended December 31, 1998 from $1.6 million for the year ended December 31, 1997, primarily representing investment in the Company's new corporate facilities, equipment for the central radiolabeling facility and equipment and furniture related to increased staffing. Net cash provided by financing activities decreased to $75.4 million for the year ended December 31, 1998 from $81.7 million for the year ended December 31, 1997, resulting primarily from lower proceeds from public offerings of the Company's common stock, partially offset by a $7.5 million purchase of common stock by SB in accordance with the joint development and commercialization agreement. Net cash used in operations was $21.1 million for the year ended December 31, 1997, compared to $10.4 million for the year ended December 31, 1996. This increase is primarily the result of the increased net loss for the period ended December 31, 1997. Net cash used in investing activities increased to $49.0 million for the year ended December 31, 1997 from $8.5 million for the year ended December 31, 1996, primarily resulting from the purchase of $61.5 million in short-term investments using a portion of the proceeds from the Company's sales of common stock in January and October 1997. The Company's capital expenditures increased to $1.6 million for the year ended December 31, 1997 from $0.9 million for the year ended December 31, 1996, primarily representing investment in equipment for the central radiolabeling facility and equipment and furniture related to increased staffing. Net cash provided by financing activities increased to $81.7 million for the year ended December 31, 1997 from $24.3 million for the year ended December 31, 1996, resulting primarily from the public offerings of the Company's common stock in January and October 1997. The Company expects that its existing capital resources, including the net proceeds of its public offerings and interest thereon, will be adequate to satisfy the requirements of its current and planned operations through 2000. At December 31, 1998, the Company had entered into a long-term lease obligation for office and laboratory space that will require material commitments for capital expenditures. The Company's future capital requirements will depend on a number of factors, including: the scope and results of preclinical studies and clinical trials; continued progress of the Company's research and development of potential products; the cost, timing and outcome of regulatory approvals; the expenses of establishing a sales and marketing force; the timing and cost of establishment or procurement of requisite production, radiolabeling and other capacities; the cost involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims; the need to acquire licenses to new technology; the status of competitive products; the availability of other financing and the ability to achieve profitability. YEAR 2000 READINESS The Company uses and relies on a wide variety of information technologies, computer systems and scientific equipment containing computer related components. Some of the Company's older computer software programs and equipment use two digit fields rather than four digit fields to define the applicable year (i.e., "98" in the computer code refers to the year "1998"). As a result, time-sensitive functions of those software programs and equipment may misinterpret dates after January 1, 2000, to refer to the twentieth century rather than the twenty-first century (i.e., "02" could be interpreted as "1902" rather than "2002"). This could cause system or equipment shutdowns, failures or miscalculations resulting in inaccuracies in computer output or disruptions of operations, including, among other things, inaccurate processing of financial information and/or temporary inability to process transactions or engage in other normal business activities. The Company has developed a strategy to address the potential exposures related to the impact on its computer systems for the Year 2000 and beyond. An inventory of key financial, informational and operational systems is being completed. Detailed plans for implementation and testing of any necessary modifications to these key computer systems and equipment to ensure they are Year 2000 compliant are being developed by a cross functional team to address computer system and equipment problems as required by December 31, 1999. The Company believes that with these plans and completed modifications, the Year 2000 issue will not pose significant operational problems for its computer systems and equipment. However, if such modifications and conversions are not made, or are not completed in a timely fashion, the Year 2000 issue could have a material 36 37 impact on the operations of the Company, the precise degree of which cannot be known at this time. The Company currently has no contingency plans to deal with major Year 2000 failures, though such plans, if necessary, will be developed over the coming months. The Company does not expect the resources required to be devoted to Year 2000 compliance to cause significant delay in other projects. The Company is currently considering the need for external verification of its Year 2000 readiness and that of its partners. In addition to risks associated with the Company's own computer systems and equipment, the Company has relationships with, and is to varying degrees dependent upon, a large number of third parties that provide information, goods and services to the Company. These include financial institutions, suppliers, vendors, research partners and governmental entities. If a significant number of these third parties experience failures in their computer systems or equipment due to Year 2000 non-compliance, it could affect the Company's ability to process transactions, develop, manufacture and distribute products, or engage in similar normal business activities. While some of these risks are outside the control of the Company, the Company has instituted programs, including internal records review and use of external questionnaires, to identify key third parties, assess their level of Year 2000 compliance, update contracts and address any non-compliance issues. The total cost of the Year 2000 systems assessments and conversions is funded through operating cash flows, and the Company is expensing these costs. The financial impact of making the required systems changes and ensuring that key third-parties are Year 2000 compliant is not known precisely at this time, but it is currently expected to be less than $1.0 million. The amount of the cost incurred to date is less than $50,000. The actual financial impact could, however, exceed this estimate. These costs are not expected to be material to the Company's financial position, results of operations or cash flows. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK In the normal course of business, the financial position of the Company is routinely subjected to a variety of risks, including market risk associated with interest rate movements and currency rate movements on non-United States dollar denominated assets and liabilities. The Company regularly assesses these risks and has established policies and business practices to protect against the adverse effects of these and other potential exposures. As a result, the Company does not anticipate material losses in these areas. Interest Rates -- The Company's interest income is sensitive to changes in the general level of interest rates, primarily United States interest rates. In this regard, changes in United States interest rates affect the interest earned on the Company's cash equivalents and short-term investments. Based on the Company's overall interest rate exposure at December 31, 1998, a near-term change in interest, based on historical currency rate movements, would not materially affect the fair value of interest rate sensitive instruments. Foreign Currency Exchange Rates -- The Company has certain liabilities which are denominated in several European currencies. As a result, the Company's financial results could be significantly affected by factors such as changes in foreign currency exchange rates or economic conditions in the foreign markets in which the Company's suppliers are located. To mitigate this risk, the Company may enter into foreign currency forward contracts as is deemed necessary by management. Based on the Company's overall currency rate exposure at December 31, 1998, a near-term change in currency rates, based on historical currency rate movements, would not materially affect the fair value of foreign currency sensitive instruments. 37 38 The Company invests cash which is not currently being used for operational purposes in accordance with its investment policy. This policy allows for the purchase of low risk securities issued by the government agencies and very highly rated banks and corporations subject to certain concentration limits. The maturities of these securities are maintained at less than one year. The following table presents the amounts and related weighted average interest rates by year of maturity for the Company's investment portfolio and long term debt obligations at December 31, 1998:
1999 2000 2001 2002 2003 THEREAFTER TOTAL ------- ---- ---- ---- ----- ---------- ------- (DOLLARS IN THOUSANDS) Cash Equivalent Investments: Fixed Rate................... $84,162 -- -- -- -- -- $84,162 Average Interest Rate........ 5.3% -- -- -- -- -- -- Short Term Investments: Fixed Rate................... 49,970 -- -- -- -- -- 49,970 Average Interest Rate........ 5.5% -- -- -- -- -- -- Long-term debt, including current portion: Variable Rate................ 119 714 714 714 2,739 -- 5,000 Average Interest Rate........ 8.75% 8.75% 8.75% 8.75% 8.75% -- --
38 39 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA REPORT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS The Board of Directors and Stockholders Coulter Pharmaceutical, Inc. We have audited the accompanying consolidated balance sheets of Coulter Pharmaceutical, Inc. (a development stage company) (the "Company") as of December 31, 1997 and 1998, and the related consolidated statements of operations and cash flows for each of the three years in the period ended December 31, 1998 and for the period from inception (February 16, 1995) to December 31, 1998 and the related statement of stockholders' equity for the period from inception (February 16, 1995) to December 31, 1998. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Coulter Pharmaceutical, Inc. at December 31, 1997 and 1998, and the consolidated results of its operations and its cash flows for each of the three years in the period ended December 31, 1998 and for the period from inception (February 16, 1995) to December 31, 1998, in conformity with generally accepted accounting principles. /s/ ERNST & YOUNG LLP Palo Alto, California January 27, 1999 39 40 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) CONSOLIDATED BALANCE SHEETS (IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS) ASSETS
DECEMBER 31, DECEMBER 31, 1997 1998 ------------ ------------ Current assets: Cash and cash equivalents................................. $ 20,451 $ 89,808 Short-term investments.................................... 54,994 49,970 Prepaid expenses and other current assets................. 269 3,063 -------- -------- Total current assets.............................. 75,714 142,841 Property and equipment, net................................. 2,263 9,449 Employee loans receivable................................... 568 907 Other assets................................................ 126 233 -------- -------- $ 78,671 $153,430 ======== ======== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable.......................................... $ 1,838 $ 4,068 Accrued liabilities....................................... 7,959 6,353 Current portion of equipment financing obligations and debt facility.......................................... 715 1,157 -------- -------- Total current liabilities......................... 10,512 11,578 Non current portion of equipment financing obligations and debt facility............................................. 2,298 6,659 Commitments Stockholders' equity: Preferred stock, issuable in series, $.001 par value: 20,000,000 shares authorized; none outstanding at December 31, 1997 and 1998............................ -- -- Common stock, $.001 par value: 30,000,000 shares authorized; 13,570,224 and 16,704,103 shares issued and outstanding at December 31, 1997 and 1998, respectively.................................... 14 17 Additional paid-in capital.................................. 111,598 182,390 Accumulated other comprehensive loss........................ (7) (32) Deferred compensation....................................... (1,085) (565) Deficit accumulated during the development stage............ (44,659) (46,617) -------- -------- Total stockholders' equity........................ 65,861 135,193 -------- -------- $ 78,671 $153,430 ======== ========
See accompanying notes. 40 41 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA)
FOR THE PERIOD FROM YEAR ENDED DECEMBER 31, INCEPTION ------------------------------- (FEB. 16, 1995) 1996 1997 1998 TO DECEMBER 31, 1998 -------- -------- ------- -------------------- Corporate partner revenues............... $ -- $ -- $34,250 $ 34,250 Operating expenses: Research and development............... 13,681 21,045 28,698 65,963 Selling, general and administrative.... 2,409 7,610 11,758 22,358 -------- -------- ------- -------- Total operating expenses................. 16,090 28,655 40,456 88,321 Interest income and other, net........... 752 2,327 4,248 7,454 -------- -------- ------- -------- Net loss................................. $(15,338) $(26,328) $(1,958) $(46,617) ======== ======== ======= ======== Basic and diluted net loss per share..... $(649.39) $ (2.58) $ (0.13) -------- -------- ------- Shares used in computing basic and diluted net loss per share............. 24 10,197 14,562 ======== ======== =======
See accompanying notes. 41 42 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
CONVERTIBLE PREFERRED ACCUMULATED STOCK COMMON STOCK ADDITIONAL OTHER ---------------------- ------------------- PAID-IN COMPREHENSIVE DEFERRED SHARES AMOUNT SHARES AMOUNT CAPITAL LOSS COMPENSATION ----------- -------- ---------- ------ ---------- ------------- ------------ Issuance of Series A convertible preferred stock to founders at $1.00 per share for cash and technology in February 1995....................... 7,500,000 $ 2,500 -- $-- $ -- $ -- $ -- Issuance of Series B convertible preferred stock to a founder at $1.50 per share for cash in August and October 1995, less issuance costs of $11...... 2,333,333 3,489 -- -- -- -- -- Exercise of common stock options by a consultant at $0.30 per share for cash in November 1995.............. -- -- 2,059 -- 1 -- -- Net loss..................... -- -- -- -- -- -- -- ----------- -------- ---------- --- -------- ---- ------- Balances at December 31, 1995....................... 9,833,333 $ 5,989 2,059 -- $ 1 -- -- Issuance of Series C convertible preferred stock and warrants for 498,705 shares of common stock to investors at $2.25 per share for cash in April 1996, less issuance costs of $55..................... 9,964,607 22,366 -- -- -- -- -- Issuance of common stock to a prospective officer at $0.45 per share for cash in March 1996................. -- -- 400,000 1 179 -- -- Issuance of common stock pursuant to stock option exercises.................. -- -- 35,553 -- 14 -- -- Deferred compensation related to grants of certain stock options.................... -- -- -- -- 2,294 -- (2,294) Amortization of deferred compensation............... -- -- -- -- -- -- 330 Net loss..................... -- -- -- -- -- -- -- Unrealized loss on securities available-for-sale, net.... -- -- -- -- -- (3) -- Comprehensive Loss......... -- -- -- -- -- -- -- ----------- -------- ---------- --- -------- ---- ------- Balances at December 31, 1996....................... 19,797,940 $ 28,355 437,612 $ 1 $ 2,488 $ (3) $(1,964) DEFICIT ACCUMULATED DURING THE TOTAL DEVELOPMENT STOCKHOLDERS' STAGE EQUITY ----------- ------------- Issuance of Series A convertible preferred stock to founders at $1.00 per share for cash and technology in February 1995....................... $ -- $ 2,500 Issuance of Series B convertible preferred stock to a founder at $1.50 per share for cash in August and October 1995, less issuance costs of $11...... -- 3,489 Exercise of common stock options by a consultant at $0.30 per share for cash in November 1995.............. -- 1 Net loss..................... (2,993) (2,993) -------- -------- Balances at December 31, 1995....................... $ (2,993) $ 2,997 Issuance of Series C convertible preferred stock and warrants for 498,705 shares of common stock to investors at $2.25 per share for cash in April 1996, less issuance costs of $55..................... -- 22,366 Issuance of common stock to a prospective officer at $0.45 per share for cash in March 1996................. -- 180 Issuance of common stock pursuant to stock option exercises.................. -- 14 Deferred compensation related to grants of certain stock options.................... -- Amortization of deferred compensation............... -- 330 Net loss..................... (15,338) (15,338) Unrealized loss on securities available-for-sale, net.... -- (3) -------- Comprehensive Loss......... -- (15,341) -------- -------- Balances at December 31, 1996....................... $(18,331) $ 10,546
See accompanying notes. 42 43 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (CONTINUED) (IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
CONVERTIBLE PREFERRED ACCUMULATED STOCK COMMON STOCK ADDITIONAL OTHER ---------------------- ------------------- PAID-IN COMPREHENSIVE DEFERRED SHARES AMOUNT SHARES AMOUNT CAPITAL LOSS COMPENSATION ----------- -------- ---------- ------ ---------- ------------- ------------ Conversion of convertible preferred stock into common stock...................... (19,797,940) $(28,355) 6,599,287 $ 6 $ 28,349 $ -- $ -- Issuance of 2,875,000 shares of common stock at $12.00 per share less issuance costs of $3,226............ -- -- 2,875,000 3 31,274 -- -- Issuance of common stock pursuant to stock options exercises.................. -- -- 77,358 -- 45 -- -- Issuance of common stock pursuant to warrant exercises.................. -- -- 385,315 1 3,127 -- -- Deferred compensation related to grant of certain stock options.................... -- -- -- -- 206 -- (206) Amortization of deferred compensation............... -- -- -- -- -- -- 1,085 Issuance of common stock pursuant to the employee stock purchase plan........ -- -- 33,152 -- 280 -- -- Issuance of 3,162,500 shares of common stock at $15.50 per share less issuance costs of $3,190............ -- -- 3,162,500 3 45,829 -- -- Net loss..................... -- -- -- -- -- -- -- Unrealized loss on securities available-for-sale, net.... -- -- -- -- -- (4) -- Comprehensive Loss......... -- -- -- -- -- -- -- ----------- -------- ---------- --- -------- ---- ------- Balance at December 31, 1997....................... -- -- 13,570,224 14 111,598 (7) (1,085) Issuance of 239,607 shares of common stock pursuant to contract with corporate partner.................... -- -- 239,607 -- 7,250 -- -- Issuance of common stock pursuant to stock options exercises.................. -- -- 164,785 -- 538 -- -- Issuance of common stock pursuant to warrant exercise................... -- -- 16,787 -- -- -- -- Deferred compensation related to grant of certain stock options.................... -- -- -- -- 156 -- (156) Amortization of deferred compensation............... -- -- -- -- -- -- 676 Issuance of common stock pursuant to the employee stock purchase plan........ -- -- 67,700 -- 712 -- -- Issuance of 2,645,000 shares of common stock at $25.00 per share less issuance costs of $3,986............ -- -- 2,645,000 3 62,136 -- -- Net loss..................... -- -- -- -- -- -- -- Unrealized loss on securities available-for-sale, net.... -- -- -- -- -- (25) -- Comprehensive Loss......... -- -- -- -- -- -- -- ----------- -------- ---------- --- -------- ---- ------- Balance at December 31, 1998....................... -- $ -- 16,704,103 $17 $182,390 $(32) $ (565) =========== ======== ========== === ======== ==== ======= DEFICIT ACCUMULATED DURING THE TOTAL DEVELOPMENT STOCKHOLDERS' STAGE EQUITY ----------- ------------- Conversion of convertible preferred stock into common stock...................... $ -- $ -- Issuance of 2,875,000 shares of common stock at $12.00 per share less issuance costs of $3,226............ -- 31,277 Issuance of common stock pursuant to stock options exercises.................. -- 45 Issuance of common stock pursuant to warrant exercises.................. -- 3,128 Deferred compensation related to grant of certain stock options.................... -- -- Amortization of deferred compensation............... -- 1,085 Issuance of common stock pursuant to the employee stock purchase plan........ -- 280 Issuance of 3,162,500 shares of common stock at $15.50 per share less issuance costs of $3,190............ -- 45,832 Net loss..................... (26,328) (26,328) Unrealized loss on securities available-for-sale, net.... -- (4) -------- Comprehensive Loss......... -- (26,332) -------- -------- Balance at December 31, 1997....................... (44,659) 65,861 Issuance of 239,607 shares of common stock pursuant to contract with corporate partner.................... -- 7,250 Issuance of common stock pursuant to stock options exercises.................. -- 538 Issuance of common stock pursuant to warrant exercise................... -- -- Deferred compensation related to grant of certain stock options.................... -- -- Amortization of deferred compensation............... -- 676 Issuance of common stock pursuant to the employee stock purchase plan........ -- 712 Issuance of 2,645,000 shares of common stock at $25.00 per share less issuance costs of $3,986............ -- 62,139 Net loss..................... (1,958) (1,958) Unrealized loss on securities available-for-sale, net.... -- (25) -------- Comprehensive Loss......... -- (1,983) -------- -------- Balance at December 31, 1998....................... $(46,617) $135,193 ======== ========
See accompanying notes. 43 44 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) CONSOLIDATED STATEMENTS OF CASH FLOWS INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (IN THOUSANDS)
FOR THE PERIOD FROM INCEPTION (FEBRUARY 16, YEAR ENDED DECEMBER 31, 1995) TO ----------------------------- DECEMBER 31, 1996 1997 1998 1998 -------- -------- ------- -------------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss............................................ $(15,338) $(26,328) $(1,958) $(46,617) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization..................... 49 250 712 1,023 Amortization of deferred compensation............. 330 1,085 676 2,091 Changes in operating assets and liabilities: Prepaid expenses and other current assets......... (459) 230 (2,794) (3,063) Employee loans receivable......................... (389) (148) (339) (907) Other assets...................................... (9) (91) (107) (233) Accounts payable.................................. 1,235 237 2,230 4,068 Accrued liabilities............................... 4,152 3,629 (1,604) 6,442 -------- -------- ------- -------- Net cash used in operating activities..... (10,429) (21,136) (3,184) (37,196) -------- -------- ------- -------- CASH FLOWS FROM INVESTING ACTIVITIES: Purchases of short-term investments................. (10,879) (61,525) (82,336) (154,740) Maturities of short-term investments................ 986 14,144 82,261 97,391 Sale of short-term investments...................... 2,270 -- 5,073 7,343 Purchases of property and equipment................. (876) (1,589) (7,899) (10,469) -------- -------- ------- -------- Net cash used in investing activities..... (8,499) (48,970) (2,901) (60,475) -------- -------- ------- -------- CASH FLOWS FROM FINANCING ACTIVITIES: Payments of equipment financing obligations and debt facility.......................................... (44) (531) (817) (1,392) Borrowings under equipment financing obligations and debt facility..................................... 1,800 1,700 5,620 9,120 Proceeds from issuances of convertible preferred stock, net........................................ 22,366 -- -- 28,355 Proceeds from issuance of common stock, net......... 194 80,562 70,639 151,396 -------- -------- ------- -------- Net cash provided by financing activities........... 24,316 81,731 75,442 187,479 -------- -------- ------- -------- Net increase in cash and cash equivalents........... 5,388 11,625 69,357 89,808 Cash and cash equivalents at beginning of period.... 3,438 8,826 20,451 -- -------- -------- ------- -------- Cash and cash equivalents at end of period.................................. $ 8,826 $ 20,451 $89,808 $ 89,808 ======== ======== ======= ======== SUPPLEMENTAL SCHEDULE OF CASH FLOW INFORMATION: Interest paid....................................... $ -- $ 283 $ 385 $ 668 Schedule of non-cash investing and financing activities: Net exercises of warrant to purchase common stock... $ -- $ 453 $ 512 $ 965 Acquisition of equipment pursuant to supplemental lease obligation.................................. $ 78 $ -- $ -- $ 78 Deferred compensation related to grant of certain stock options..................................... $ 2,294 $ 206 $ 156 $ 2,656
See accompanying notes. 44 45 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization and Principles of Consolidation Coulter Pharmaceutical, Inc. (the "Company" or "Coulter") was incorporated in the State of Delaware on February 16, 1995 to engage in the research and development of products for the treatment of cancer. The Company's principal activities to date have involved conducting research and development, recruiting management and technical personnel, obtaining financing and securing operating facilities. Therefore, the Company is classified as a development stage company. In the course of its development activities, the Company has sustained continuing operating losses and expects such losses to continue over the next several years. The Company plans to continue to finance its operations with a combination of stock sales, collaborative agreements with corporate partners, revenues from product sales and technology licenses. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, Coulter Pharma Belgium, SA which was formed under the laws of Belgium in June 1996. Intercompany balances and transactions have been eliminated. In connection with its formation, the Company issued 5,000,000 shares of its Series A preferred stock (since converted to 1,666,666 shares of common stock) to Coulter Corporation in exchange for rights to certain intellectual property, contractual rights and other assets pertaining to Bexxar(TM). In 1997 Beckman Instruments acquired Coulter Corporation (now known as "Beckman Coulter"). Prior to the acquisition, all shares of the Company's stock were distributed to the members of the Coulter family. Beckman Coulter retains the rights to the assignment agreement and under the terms of the agreement, royalties are payable to Beckman Coulter upon commercial sale of product, if any, derived from these licenses. Beckman Coulter also has the right, in lieu of receiving cash, to purchase shares of the Company's equity securities at the then current fair market value of such securities with respect to the first $4.5 million payable to Beckman Coulter under this assignment agreement. This transaction was accounted for as an acquisition of assets from an affiliate with the amounts brought over at their historical basis of $0. Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Net Loss Per Share Effective December 31, 1997, the Company adopted Statement of Financial Accounting Standard No. 128, "Earnings Per Share," ("SFAS 128") and Securities and Exchange Commission Staff Accounting Bulletin No. 98 ("SAB 98"). SFAS 128 requires the presentation of basic earnings (loss) per share and diluted earnings (loss) per share, if dilutive, for all periods presented. Basic earnings per share is computed by dividing income or loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period net of certain common shares outstanding which are subject to continued vesting and the Company's right to repurchase. Basic earnings per share excludes any dilutive effects of options, warrants and convertible securities. Diluted net loss per share has not been presented separately as, given the Company's net loss position, the result would be antidilutive. SAB 98 eliminates the inclusion in the calculation of net loss per share of common and common equivalent shares (stock options, warrants, convertible notes and preferred stock) issued during the 12 month period prior to an initial public offering at prices below the initial public offering price as if they were outstanding for all periods presented. All loss per 45 46 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) share amounts for all periods presented have been presented and, where appropriate, restated to conform to SFAS 128 and SAB 98. The following have been excluded from the calculation of loss per share because the effect of inclusion would be antidilutive: approximately 150,000 common shares which are outstanding but are subject to the Company's right of repurchase which expires June 30, 2000; and options to purchase approximately 2,506,500 shares of common stock at a weighted average price of $15.46 per share. The repurchasable shares and options will be included in the calculation at such time as the effect is no longer antidilutive, as calculated using the treasury stock method. A reconciliation of shares used in the calculation of basic and diluted net loss per share follows:
YEAR ENDED DECEMBER 31, ------------------------------------------- 1996 1997 1998 ------------ ------------ ----------- Net loss.......................................... $(15,338,000) $(26,328,000) $(1,958,000) ============ ============ =========== Basic and diluted Weighted-average shares of common stock outstanding used in computing basic and diluted net loss per share.............................. 23,619 10,197,225 14,561,950 ============ ============ =========== Basic and diluted net loss per share.............. $ (649.39) $ (2.58) $ (0.13) ============ ============ ===========
Current Vulnerability to Certain Concentrations The Company has contracted with two third-party manufacturers, Boehringer Ingleheim Pharma KG ("BI Pharma KG") and LONZA Biologics plc ("Lonza"), to produce a monoclonal antibody (the "Anti-B1 Antibody"). The Company has also contracted with a third-party manufacturer, MDS Nordion, Inc. ("Nordion") for the radiolabeling of the Anti-B1 Antibody in a centralized facility. However, should the Company not be able to obtain sufficient quantities of the Anti-B1 Antibody from BI Pharma KG or Lonza or radiolabeled Anti-B1 Antibody from Nordion, or additional suppliers, certain research and development activities may be delayed. Cash, Cash Equivalents and Short-Term Investments The Company considers all highly liquid investments with maturities of three months or less from the date of purchase to be cash equivalents. Short-term investments consist of investments with original maturities greater than three months, but less than two years. The Company accounts for its cash equivalents and short-term investments under Statement of Financial Accounting Standards No. 115, "Accounting for Certain Investments in Debt and Equity Securities" ("SFAS 115"). Under the provisions of SFAS 115, the Company has classified its cash equivalents and short-term investments as "available-for-sale." Such investments are recorded at fair value and unrealized gains and losses, which are considered to be temporary, are recorded as a separate component of stockholders' equity until realized. Realized gains and losses and declines in value judged to be other than temporary on available-for-sale securities are included in interest income. The cost of securities sold is based on the specific identification method. The Company classifies all investments in its available-for-sale portfolio as current assets. Revenue Recognition Nonrefundable contract fees for which no further performance obligations exist are recognized when the payments are received or when collection is assured. In return for contract payments, contract partners may receive certain marketing and manufacturing rights or products for clinical use and testing. 46 47 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) Foreign Currency Translation The functional currency of Coulter Pharma Belgium, SA is the United States Dollar. Assets and liabilities of Coulter Pharma Belgium, SA are translated at current exchange rates, and the related revenues and expenses are translated at average exchange rates in effect during the period. The resulting translation adjustment is recorded in selling, general and administrative expense in the accompanying consolidated statements of operations and has been immaterial since the formation of the subsidiary in June 1996. Property and Equipment Purchased property and equipment are stated at cost less accumulated depreciation which is calculated using the straight-line method over the estimated useful lives of the respective assets of three to five years. Sponsored Research and License Fees Research and development expenses paid to third parties under sponsored research arrangements are recognized as the related services are performed, generally ratably over the period of service. License fees are expensed when the related obligation is incurred. Stock-Based Compensation The Company generally grants stock options to employees for a fixed number of shares with an exercise price equal to the fair value at the date of grant. In accordance with the provisions of Statement of Financial Accounting Standards No. 123, "Accounting for Stock-Based Compensation" ("SFAS 123"), the Company has elected to follow Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees" ("APB 25"), and related interpretations in accounting to employees under its stock option plans and to adopt the pro forma disclosure alternative as described in SFAS 123 (See Note 10). Options granted to all others are accounted for using the fair value method prescribed by SFAS 123. New Accounting Standards As of January 1, 1998, the Company adopted Statement of Financial Accounting Standards No. 130, "Reporting Comprehensive Income" ("SFAS 130"). SFAS 130 established new rules for the reporting and display of comprehensive income and its components; however, the adoption of SFAS 130 had no impact on the Company's net loss or stockholder's equity. SFAS 130 requires unrealized gains or losses on the Company's available-for-sale securities which, prior to adoption, were reported separately in stockholders' equity, to be included in other comprehensive income or loss. Prior year financial statements have been reclassified to conform to the requirements of SFAS 130. Effective January 1, 1998, the Company adopted Statement of Financial Accounting Standards No. 131, "Disclosures About Segments of an Enterprise and Related Information" ("SFAS 131"). SFAS 131 superseded SFAS 14, "Financial Reporting for Segments of a Business Enterprise." SFAS 131 establishes standards for the way that public business enterprises report selected information about operating segments in annual financial statements. SFAS 131 also establishes standards for related disclosures about products and services, geographic areas and major customers. Because the Company operates as one reportable segment, the adoption of SFAS 131 will have no impact on the Company's consolidated results of operations or financial position. In June 1998, Statement of Financial Accounting Standards No. 133, "Accounting for Derivative Instruments and Hedging Activities" ("SFAS 133") was issued. Adoption is required in fiscal years beginning after June 15, 1999. Because the Company does not use derivatives, management does not anticipate that the adoption of SFAS 133 will have a significant impact on the Company's consolidated financial position or results of operations. 47 48 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 2. CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS The following is a summary of available-for-sale securities (in thousands):
GROSS GROSS AMORTIZED UNREALIZED UNREALIZED ESTIMATED COST GAINS LOSSES FAIR VALUE --------- ---------- ---------- ---------- December 31, 1998 Money market funds...................... $ 1,719 $-- $ -- $ 1,719 Commercial paper........................ 100,897 -- (8) 100,889 Corporate Bond.......................... 17,624 4 (29) 17,599 Certificates of deposit................. 13,924 1 -- 13,925 -------- --- ---- -------- Total......................... 134,164 5 (37) 134,132 Less amounts classified as cash equivalents........................... (84,170) -- (8) (84,162) -------- --- ---- -------- Total short-term investments................. $ 49,994 $ 5 $(29) $ 49,970 ======== === ==== ======== December 31, 1997 Money market funds...................... $ 1,409 $-- $ -- $ 1,409 Commercial paper........................ 22,792 -- (7) 22,785 Corporate Bond.......................... 23,661 5 (8) 23,658 US Government-backed securities......... 11,061 -- (4) 11,057 Certificates of deposits................ 16,316 4 -- 16,320 -------- --- ---- -------- Total......................... 75,239 9 (19) 75,229 Less amounts classified as cash equivalents........................... (20,238) -- (3) (20,235) -------- --- ---- -------- Total short-term investments................. $ 55,001 $ 9 $(16) $ 54,994 ======== === ==== ========
Realized gain or losses on available-for-sale securities for the years ended December 31, 1998, 1997 and 1996 were not significant. At December 31, 1998, the contractual maturities of short-term investments were as follows (in thousands):
AMORTIZED ESTIMATED COST FAIR VALUE --------- ---------- Due in one year or less........................ $42,752 $42,726 Due after one year through two years........... 7,242 7,244 ------- ------- $49,994 $49,970 ======= =======
3. PROPERTY AND EQUIPMENT Property and equipment consists of the following at December 31 (in thousands):
1997 1998 ------ ------ Machinery and equipment............................ $1,427 $4,737 Furniture and fixtures............................. 176 480 Construction in process............................ 967 5,252 ------ ------ 2,570 10,469 Less accumulated depreciation and amortization..... (307) (1,020) ------ ------ Property and Equipment............................. $2,263 $9,449 ====== ======
48 49 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) 4. SPONSORED RESEARCH AND LICENSE AGREEMENTS The Company has entered into numerous agreements with research institutions, universities, and other entities for the performance of research and development activities and for the acquisition of licenses related to those activities. Included in research and development expenses for 1998, 1997, 1996 and for the period from inception (February 16, 1995) to December 31, 1998 is $0.8 million, $0.8 million, zero and $1.6 million, respectively, to fund activities under these agreements. As of December 31, 1998, noncancelable commitments under these arrangements were approximately $0.8 million. In order to maintain certain of these licenses, the Company must pay specified annual license fees. Certain of the licenses provide for the payment of royalties by the Company on future product sales, if any. 5. COLLABORATIVE DEVELOPMENT AND COMMERCIALIZATION AGREEMENTS In December 1998, the Company and SmithKline Beecham Corporation ("SB") entered into a collaborative agreement for the development and commercialization of Bexxar, which is in late-stage development for the treatment of non-Hodgkin's lymphoma (NHL). Under the terms of the agreement, Coulter may receive milestone payments, shared profits and royalties. The agreement also provides for the sharing of certain costs related to clinical development, manufacturing development, and sales & marketing costs. The Company and SB will prepare a joint profit & loss statement to account for the sharing of sales, cost of goods sold, and costs related to selling, marketing, distribution and certain other Bexxar-related activities. Research and Development expenses for 1998 have been reduced by approximately $2.2 million which has been charged to SB under the terms of the agreement. The agreement provides for an upfront non-refundable license fee of $34.25 million and the purchase of $7.25 million of the Company's common stock. The license fee was recognized as corporate partner revenues in fiscal year 1998. In addition, the agreement provides for a $15.0 million credit line. The Company may receive additional payments based upon completion of certain milestones. Future development expenses for Bexxar will generally be shared by both companies, with the Company retaining responsibility for funding certain predetermined development costs. In addition, the companies will jointly explore the potential of other indications for the product. Upon regulatory approval, the Company and SB will jointly market Bexxar in the United States following regulatory approval, and the two companies will share profits and losses equally. Outside the United States, excluding Japan, the Company has granted SB exclusive marketing and distribution rights in return for product royalties. SB may also have access to second generation anti-CD20 compounds. 6. ACCRUED LIABILITIES Accrued liabilities consists of the following at December 31 (in thousands):
1997 1998 ------ ------ Accrued research and development expenses.......... $6,426 $4,028 Accrued clinical trial costs....................... 620 543 Other.............................................. 913 1,782 ------ ------ Total.................................... $7,959 $6,353 ====== ======
7. LONG TERM DEBT Equipment Financing In December 1996, the Company entered into a $3,827,000 equipment lease financing and debt facility with a financing company, none of which remain available at December 31, 1998. The Company makes 49 50 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) monthly payments plus interest on amounts borrowed over the 48-month term of the facility followed by a balloon payment. Interest rates under the facility range from 11.75% to 11.93%. Amounts outstanding under the equipment facility are secured by the underlying assets. Included in property and equipment at December 31, 1998 are assets with a cost of $1,486,000 ($1,165,000 at December 31, 1997) acquired pursuant to a fixed interest rate equipment loan. Accumulated amortization of assets acquired pursuant to these obligations was approximately $456,000 and $196,000 at December 31, 1998 and 1997, respectively. Operating Lines of Credit In November 1998, the Company entered into a $10.0 million revolving loan facility with a commercial bank of which $5.0 million remained available at December 31, 1998. The loan is secured by the assets of the Company. Interest is paid each month on the outstanding balance at prime rate plus 0.5% (8.75% at December 31, 1998) . In accordance with the agreement principal payments are due in 48 monthly installments beginning in November 1999, followed by a balloon payment of approximately $2.1 million due in November 2003. The agreement also requires the maintenance of a $5 million compensating balance with the bank until the entire amount of the facility has been drawn down. At December 31, 1998, the Company's aggregate commitment under such agreements, together with the net present value of the obligations, is as follows (in thousands):
YEARS ENDING DECEMBER 31: ------------------------- 1999.............................................. $1,855 2000.............................................. 2,441 2001.............................................. 1,585 2002.............................................. 1,072 2003.............................................. 2,859 ------ 9,812 Less amounts representing interest.................. (1,996) Less current portion................................ (1,157) ------ $6,659 ======
8. COMMITMENTS The Company leases its offices under operating leases which expire at various dates beginning in 1999 through 2010. Rent expense under these leases totaled approximately $1,057,000, $461,000, $186,000 and $1,775,000 for the years ended December 31, 1998, 1997 and 1996, and for the period from inception (February 16, 1996) to December 31, 1998, respectively. At December 31, 1998, the aggregate noncancelable future minimum payments under the operating leases are as follows (in thousands):
OPERATING YEARS ENDING DECEMBER 31: LEASES ------------------------- --------- 1999............................................. $ 2,278 2000............................................. 2,295 2001............................................. 2,316 2002............................................. 2,227 2003............................................. 2,210 Thereafter....................................... 17,510 ------- Total.................................... $28,836 =======
50 51 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) On November 7, 1997, the Company entered into an agreement to lease additional facilities. The lease was amended on November 10, 1998 to include a second building. The monthly rent payments range from $78,000 to $241,000 throughout the term of the lease. In connection with this lease agreement, the Company obtained a $2 million letter of credit agreement from a bank which secures the aggregate future payments under the lease. At December 31, 1998, the Company had approximately $16.1 million in noncancelable purchase commitments with BI Pharma KG and Lonza, two of its third party manufacturers. In the event of cancellation by Coulter prior to fulfillment of its obligation, the agreements contain certain economic penalty provisions which would be applied and determined at the point in time when cancellation occurs. 9. RELATED PARTY TRANSACTIONS The Company issued loans to employees totaling $485,000 prior to December 31, 1996. These loans were either repaid in full or converted to new loan agreements in 1997. The Company entered into loan agreements with certain key employees, totaling $670,000 for the period ended December 31, 1997 and $438,000 for the period ended December 31, 1998. The loans are non-interest bearing with various terms ranging from four to ten years. The forgiven amount and the repaid amount is calculated on a pro-rata basis over years one through ten of continued employment. In the event an employee ceases to be employed by the Company, the loan becomes interest-bearing and due within a reasonable period not to exceed three months. Each loan is secured by a Second Deed of Trust on employee's residence. 10. STOCKHOLDERS' EQUITY Preferred Stock In January 1997, the Company completed its initial public offering of common stock under the Securities Act of 1933, in which approximately $31.3 million in net proceeds was realized (including net proceeds from the exercise of the underwriter's over-allotment option). Upon the completion of the initial public offering all of the Series A, B and C preferred stock outstanding converted into 6,599,287 shares of common stock. Also upon the completion of the offering, the Company's Certificate of Incorporation was amended to authorize 3,000,000 shares of preferred stock, none of which are issued or outstanding. The Company's board of directors is authorized to determine the designation, powers, preferences and rights of any such series. The company has reserved 200,000 shares of preferred stock for potential issuance under the Share Purchase Rights Plan. Common Stock In July 1998, the Company completed a follow-on public offering of 2,400,000 shares of common stock at a price to the public of $25.00 per share, resulting in net proceeds to the Company of approximately $56.3 million. Also, in August 1998, the underwriters of that offering purchased 245,000 additional shares of common stock upon a partial exercise of their over-allotment option, raising additional net proceeds of $5.8 million. The total net proceeds from this offering were $62.1 million. Equity Incentive Plans The 1995 Equity Incentive Plan (the "1995 Plan") was adopted in 1995 by the Board of Directors and allowed for the granting of options for up to 866,666 shares of common stock to employees, consultants and directors. In December 1996, the Board of Directors adopted the 1996 Equity Incentive Plan (the "1996 Plan") under which a total of 1,400,000 shares of the Company's authorized but unissued common stock has been 51 52 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) reserved for issuance thereunder. In February 1998, the Board of Directors approved an amendment to increase the number of shares of common stock authorized from 1,400,000 to 2,800,000 shares. The amendment was approved by the Company's stockholders in May 1998. Stock options granted under the 1995 and 1996 Plans (collectively, the "Plans") may be either incentive stock options or non-qualified stock options. Incentive stock options may be granted to employees with exercise prices not less than the fair market value at the date of grant and nonqualified stock options may be granted at exercise prices of no less than 85% of the fair market value of the common stock on the date of grant. The options vest over four years pursuant to a formula determined by the Company's Board of Directors and expire after ten years. The 1995 Plan terminated upon the closing of the Company's initial public offering in January 1997. Activity under the Plans was as follows:
OPTIONS OUTSTANDING ---------------------------- OPTIONS NUMBER EXERCISE WEIGHTED- AVAILABLE OF PRICE AVERAGE FOR GRANT SHARES PER SHARE EXERCISE PRICE ---------- --------- --------------- -------------- Shares authorized............. 333,333 -- $ -- $ -- Options granted............... (220,756) 220,756 $ 0.30 $ 0.30 Options exercised............. -- (2,059) $ 0.30 $ 0.30 ---------- --------- --------------- ------ Balance at December 31, 1995........................ 112,577 218,697 $ 0.30 $ 0.30 Shares authorized............. 533,333 -- $ -- -- Options granted............... (658,492) 658,492 $ 0.30 - $12.00 $ 1.99 Options exercised............. -- (35,551) $ 0.30 - $ 2.25 $ 0.41 Options canceled.............. 19,333 (19,333) $ 0.30 - $30.75 $ 0.73 ---------- --------- --------------- ------ Balance at December 31, 1996........................ 6,751 822,305 $ 0.30 - $12.00 $ 1.64 Shares authorized............. 1,400,000 -- $ -- $ -- Options granted............... (1,010,100) 1,010,100 $ 8.50 - $19.13 $10.83 Options exercised............. -- (77,358) $ 0.30 - $ 2.25 $ 0.59 Options canceled.............. 106,063 (106,063) $ 0.30 - $10.75 $ 2.04 Options terminated............ (100,314) -- $ -- -- ---------- --------- --------------- ------ Balance at December 31, 1997........................ 402,400 1,648,984 $ 0.30 - $19.13 $ 7.29 Shares authorized............. 1,400,000 -- $ -- $ -- Options granted............... (1,117,800) 1,117,800 $ 19.38 - $32.38 $24.77 Options exercised............. -- (164,785) $ 0.30 - $24.13 $ 3.26 Options canceled.............. 95,505 (95,505) $ 0.30 - $24.50 $ 4.34 Options terminated............ (63,042) -- $ -- -- ---------- --------- --------------- ------ Balance at December 31, 1998........................ 717,063 2,506,494 $ 0.30 - $32.38 $15.46 ========== ========= =============== ======
Options were exercisable to purchase 11,104 shares (at a weighted-average exercise price of $0.30 per share), 65,440 shares (at a weighted-average exercise price of $0.43 per share), 222,201 shares (at a weighted-average exercise price of $6.52 per share) and 557,676 shares (at a weighted-average exercise price of $13.30 per share) for the years ended at December 31, 1995, 1996, 1997 and 1998, respectively. 52 53 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) Exercise prices for options outstanding under the Plans as of December 31, 1998 ranged from $0.30 to $32.38 per share. The weighted-average remaining contractual life of those options is 8.8 years.
WEIGHTED- EXERCISABLE OPTIONS OPTIONS OUTSTANDING AVERAGE ------------------------ -------------------------- REMAINING WEIGHTED- WEIGHTED- CONTRACTUAL AVERAGE EXERCISE PRICE AVERAGE LIFE EXERCISE RANGE NUMBER EXERCISE PRICE (IN YEARS) NUMBER PRICE - ----------------- --------- -------------- ----------- ------- -------------- $ 0.30 - $ 4.50 .. 438,884 $ 1.6590 7.6 213,417 $ 1.3732 $ 8.50 - $ 8.50 .. 140,500 $ 8.5000 8.3 53,702 $ 8.5000 $ 8.625 - $ 8.625.. 480,417 $ 8.6250 8.6 155,346 $ 8.6250 $ 8.875 - $22.50 .. 418,893 $16.3155 8.8 108,745 $14.3813 $22.75 - $24.0313.. 155,000 $23.0849 9.6 1,226 $23.0000 $24.125 - $32.375.. 872,800 $25.5228 9.6 25,240 $24.1250 --------- -------- --- ------- -------- 2,506,494 $15.4618 8.8 557,676 $ 7.6934
The Company has reserved 3,223,557 shares of its common stock for options to purchase common shares which may be issued under the Plans. In March 1996, 400,000 shares of common stock were purchased at $0.45 per share by an officer of the Company. The Company has the right to repurchase these shares under certain conditions. At December 31, 1998, 150,000 common shares were available for repurchase. The Company recorded deferred compensation expense of $2.3 million for the difference between the exercise price and the deemed fair value for financial statement presentation purposes of the Company's common stock, as determined by the board of directors, for common stock issued and stock options granted prior to the Company's initial public offering in January 1997. Additionally, deferred compensation of approximately $361,000 was recorded based on the deemed fair values of common stock options granted subsequent to the Company's initial public offering. The deferred compensation is being amortized over the corresponding vesting period of each respective share purchase or option, generally four years. Amortization of approximately $676,000, $1.1 million, $330,000, and $2.1 million was recorded in fiscal years 1998, 1997, 1996, and for the period from inception (February 16, 1995) to December 31, 1998, respectively. Pro forma information regarding net income and earnings per share is required by SFAS 123, and has been determined as if the Company had accounted for its employee stock options under the fair value method of that Statement. The fair value of these options was estimated at the date of grant using the minimum value method with weighted-average risk-free assumptions for 1996 of 6.06%. The weighted-average expected life of the options was approximately 5.1 years 1996. The fair value of employee stock options granted subsequent to December 1996 was estimated at the date of grant using a Black-Scholes option pricing model for the single option approach and the following weighted-average assumptions:
1997 1998 ---- ---- Risk-free interest rate -- options................... 5.81% 5.32% Risk-free interest rate -- ESPP...................... 5.69% 5.50% Volatility........................................... 68% 68% Expected life in years (from granting date) -- options................................... 4.1 4.0 Expected life in years -- ESPP....................... 1.2 1.2 Dividend yield....................................... 0% 0%
The pro forma information required by SFAS 123 includes compensation expenses related to the Company's employee stock purchase plan and has also been calculated based on the fair value method using a Black-Scholes option pricing model using the weighted-average assumptions discussed above. 53 54 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) For purposes of pro forma disclosures, the estimated fair value of the options is amortized to expense over the vesting period of the options. The Company's pro forma information follows (in thousands, except for earnings per share information):
YEAR ENDED DECEMBER 31, ------------------------------- 1996 1997 1998 -------- -------- ------- Pro forma net loss.......... $(15,378) $(27,296) $(5,482) Pro forma net loss per share..................... $ (2.65) $ (2.68) $ (0.38)
The weighted average fair market value of options granted for the years ended December 31, 1996, 1997 and 1998 was $1.46, $10.83 and $24.77, respectively. 1996 Employee Stock Purchase Plan In December 1996, the Board of Directors adopted the 1996 Employee Stock Purchase Plan (the "Purchase Plan") under which employees can purchase shares of the Company's common stock based on a percentage of their compensation. The purchase price per share must be equal to at least 85% of the market value on the date offered or the date purchased. A total of 350,000 shares of common stock are reserved for issuance thereunder. As of December 31, 1998, 100,852 shares had been issued under the Purchase Plan (33,152 shares as of December, 1997). The Company has reserved sufficient shares of its common stock, which may be issued under the Purchase Plan. Share Purchase Rights Plan In July 1997, the Company adopted a Share Purchase Rights Plan (the "Rights Plan"), commonly known as a "poison pill". The Rights Plan provides for the distribution of certain rights to acquire shares of the Company's Series A Junior Participating Preferred Stock (the "Rights") as a dividend for each share of common stock held of record as of August 20, 1997. Under certain conditions involving an acquisition or proposed acquisition by any person or group holding 20% or more of the common stock, the Rights permit the holders (other than the 20% holder) to purchase the Company's common stock at a 50% discount from the market price at that time, upon payment of an exercise price of $70 per Right. In addition, in the event of certain business combinations, the Rights permit the purchase of shares of common stock of an acquirer at a 50% discount from the market price at that time. The Rights have no voting privileges and are attached to and automatically trade with the Company's common stock. The Rights expire on July 30, 2007. Warrants In January 1997, the Company received approximately $3.1 million from the cash exercise of warrants to purchase 347,530 shares of its common stock and issued an additional 37,785 shares of its common stock upon the net exercise of warrants to purchase 151,173 shares of its common stock. In May 1998, the Company issued 16,787 shares of its common stock upon the net exercise of a warrant to purchase 24,666 shares of its common stock. As of December 31, 1998, no warrants were outstanding. 11. INCOME TAXES As of December 31, 1998, the Company had federal net operating loss carryforwards of approximately $42,200,000. The federal net operating loss carryforwards will expire at various dates beginning in 2010 through 2018 if not utilized. 54 55 COULTER PHARMACEUTICAL, INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED) Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company's deferred tax assets are as follows at December 31 (in thousands):
1997 1998 -------- -------- Net operating loss carryforwards....................... $ 14,900 $ 14,700 Capitalized research and development................... 2,100 2,200 Research credit carryforwards (expiring 2010 - 2012)... 600 1,500 Other -- net........................................... 100 200 -------- -------- Total deferred tax assets.................... 17,700 18,600 Valuation allowance.................................... (17,700) (18,600) -------- -------- Net deferred tax assets................................ $ -- $ -- ======== ========
Because of the Company's lack of earnings history, the deferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by $10,400,000 during the year ended December 31, 1997. 55 56 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING FINANCIAL DISCLOSURE Not applicable. PART III ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT Identification of Directors and Executive Officers The information required by this Item concerning the Company's directors and executive officers is incorporated by reference from the Registrant's Definitive Proxy Statement filed with the Commission pursuant to Regulation 14A in connection with the 1999 Annual Meeting (the "Proxy Statement") under the headings "Nominees" and "Executive Officers." Compliance with Section 16(a) of the Exchange Act The information required by this Item is incorporated by reference from the Proxy Statement under the heading "Security Ownership of Certain Beneficial Owners and Management." ITEM 11. EXECUTIVE COMPENSATION The information required by this Item is incorporated by reference from the Proxy Statement under the heading "Executive Compensation." ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The information required by this Item is incorporated by reference from the Proxy Statement under the "Certain Transactions." ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The information required by this Item is incorporated by reference from the Proxy Statement under the heading "Certain Transactions" and "Executive Compensation." 56 57 PART IV ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K (a) LISTING OF EXHIBITS
EXHIBIT EXHIBIT FOOTNOTE NUMBER DESCRIPTION OF DOCUMENT - -------- ------- ----------------------- (1) 3.1 Amended and Restated Certificate of Incorporation of the Registrant. (1) 3.2 Bylaws of the Registrant. (1) 4.1 Reference is made to Exhibits 3.1 and 3.2. (1) 4.2 Specimen stock certificate. (1) 4.3 Amended and Restated Investors' Rights Agreement, dated April 18, 1996, between the Registrant and certain investors. (1) 4.4 Warrant Agreement to purchase Common Stock, dated December 6, 1996, between the Registrant and Lease Management Services, Inc. (1) 10.1 Form of Indemnity Agreement to be entered into between the Registrant and its officers and directors. (2) 10.2 1996 Equity Incentive Plan. (2) 10.3 Form of Equity Incentive Stock Option. (2) 10.4 Form of Nonstatutory Stock Option. (2) 10.5 1996 Employee Stock Purchase Plan. (1) 10.6 Assignment Agreement, dated February 24, 1995, between the Registrant, Beckman Coulter and certain investors. (1) 10.7 Manufacturing Agreement, dated August 20, 1996, between Lonza Biologics PLC and the Registrant. (1) 10.8 Equipment Lease Financing Agreement, dated December 6, 1996, between the Registrant and Lease Management Services, Inc. (1) 10.9+ First Amendment to Manufacturing Agreement, dated November 21, 1996, by and between Lonza Biologics PLC and the Registrant. (1) 10.10+ Development Agreement, dated November 15, 1995, by and between MDS Nordion Inc. and the Registrant. (1) 10.11+ Patent License Agreement, dated March 15, 1996, by and between the Region Wallone, the Universite Catholique de Louvain and Coulter Pharma Belgium, SA. (3) 10.12+ Second Amendment to Manufacturing Agreement, dated June 30, 1997, by and between Lonza Biologics PLC and the Registrant. (4) 10.13+ Third Amendment to Manufacturing Agreement, date September 26, 1997, by and between Lonza Biologics PLC and the Registrant. (4) 10.14+ Fourth Amendment to Manufacturing Agreement, dated September 17, 1997, by and between Lonza Biologics PLC and the Registrant (5) 10.15+ Contract Research and Development Agreement, dated October 22, 1997, by and between Dr. Karl Thomae GmbH and the Registrant. (5) 10.16+ Fifth Amendment to Manufacturing Agreement, dated October 27, 1997, by and between Lonza Biologics PLC and the Registrant. (5) 10.17+ Lease Agreement, dated November 7, 1997, by and between HMS Gateway Office L.P. and the Registrant. (6) 10.18+ Commercial Supply Agreement, dated May 28, 1998, by and between Lonza Biologics PLC and the Registrant.
57 58
EXHIBIT EXHIBIT FOOTNOTE NUMBER DESCRIPTION OF DOCUMENT - -------- ------- ----------------------- (7) 10.19+ Supply agreement, dated August 31, 1998, by and between MDS Nordion, Inc. and the Registrant. (7) 10.20+ Facilities agreement, dated August 31, 1998, by and between MDS Nordion, Inc. and the Registrant. 10.21+ Stock Purchase Agreement, dated October 23, 1998, by and between SmithKline Beecham Corporation and the Registrant. 10.22+ Security Agreement, dated October 23, 1998, by and between SmithKline Beecham Corporation and the Registrant. 10.23+ Grant of Security Interest, dated October 23, 1998, by and between SmithKline Beecham Corporation and the Registrant. 10.24+ Loan Agreement, dated October 23, 1998, by and between SmithKline Beecham Corporation and the Registrant. 10.25+ Collaboration Agreement, dated October 23, 1998, by and between SmithKline Beecham Corporation and the Registrant. 10.26+ Supply Agreement, dated November 3, 1998, by and between Boehringer Ingelheim Pharma KG and the Registrant. 10.27+ First Amendment to Lease Agreement, dated November 10, 1998, by and between HMS Gateway Office L.P. and the Registrant. 10.28+ Amendment #1 to the Collaboration Agreement, dated November 30, 1998 by and between SmithKline Beecham Corporation and the Registrant. 10.29+ Loan and Security Agreement, dated October 29, 1998, by and between Silicon Valley bank and the Registrant. (1) 21.1 Subsidiaries of the Registrant. 23.1 Consent of Ernst & Young LLP, Independent Auditors. 27.1 Financial Data Schedule.
- --------------- (1) Incorporated by reference to the indicated exhibit in the Company's Registration Statement on Form S-1 (File No. 333-17661), as amended. (2) Filed as an exhibit to the Registrant's Registration Statement on Form S-8 (No. 333-23265) and incorporated herein by reference. (3) Filed as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 1997 and incorporated herein by reference. (4) Filed as an exhibit to the Registrant's Special Report on Form 8-K filed September 29, 1997 and incorporated herein by reference. (5) Filed as an exhibit to the Registrant's Annual Report on Form 10-K for the year ended December 31, 1997 and incorporated herein by reference. (6) Filed as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 1998 and incorporated herein by reference. (7) Filed as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 1998 and incorporated herein by reference. + Portions omitted pursuant to a request of confidentiality filed separately with the Commission. (b) REPORTS ON FORM 8-K There were no reports on Form 8-K filed by the Registrant during the last quarter covered by this Report. 58 59 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized. COULTER PHARMACEUTICAL, INC. BY: /s/ MICHAEL F. BIGHAM ------------------------------------ Michael F. Bigham President and CEO Date: March 29, 1999 POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Michael F. Bigham and William G. Harris and each of them, as his true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him and in his name, place, and stead, in any and all capacities, to sign any and all amendments to this Report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming that all said attorneys-in-fact and agents, or any of them or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
SIGNATURE TITLE DATE --------- ----- ---- /s/ MICHAEL F. BIGHAM President, Chief Executive March 29, 1999 - --------------------------------------------------- Officer and Director (Michael F. Bigham) (Principal Executive Officer) /s/ WILLIAM G. HARRIS Vice President and Chief March 29, 1999 - --------------------------------------------------- Financial Officer (Principal (William G. Harris) Financial and Accounting Officer) /s/ BRIAN ATWOOD Director March 29, 1999 - --------------------------------------------------- (Brian Atwood) /s/ JOSEPH R. COULTER, III Director March 29, 1999 - --------------------------------------------------- (Joseph R. Coulter, III) /s/ DONALD L. LUCAS Director March 29, 1999 - --------------------------------------------------- (Donald L. Lucas)
59 60
SIGNATURE TITLE DATE --------- ----- ---- /s/ ROBERT MOMSEN Director March 29, 1999 - --------------------------------------------------- (Robert Momsen) /s/ ARNOLD ORONSKY Director March 29, 1999 - --------------------------------------------------- (Arnold Oronsky) /s/ GEORGE J. SELLA, JR. Director March 29, 1999 - --------------------------------------------------- (George J. Sella, Jr.) /s/ SUE VAN Director March 29, 1999 - --------------------------------------------------- (Sue Van)
60 61 EXHIBIT INDEX
EXHIBIT EXHIBIT FOOTNOTE NUMBER DESCRIPTION OF DOCUMENT - -------- ------- ----------------------- (1) 3.1 Amended and Restated Certificate of Incorporation of the Registrant. (1) 3.2 Bylaws of the Registrant. (1) 4.1 Reference is made to Exhibits 3.1 and 3.2. (1) 4.2 Specimen stock certificate (1) 4.3 Amended and Restated Investors' Rights Agreement, dated April 18, 1996, between the Registrant and certain investors. (1) 4.4 Warrant Agreement to purchase Common Stock, dated December 6, 1996, between the Registrant and Lease Management Services, Inc. (1) 10.1 Form of Indemnity Agreement to be entered into between the Registrant and its officers and directors. (2) 10.2 1996 Equity Incentive Plan. (2) 10.3 Form of Equity Incentive Stock Option. (2) 10.4 Form of Nonstatutory Stock Option. (2) 10.5 1996 Employee Stock Purchase Plan. (1) 10.6 Assignment Agreement, dated February 24, 1995, between the Registrant, Beckman Coulter and certain investors. (1) 10.7 Manufacturing Agreement, dated August 20, 1996, between Lonza Biologics PLC and the Registrant. (1) 10.8 Equipment Lease Financing Agreement, dated December 6, 1996, between the Registrant and Lease Management Services, Inc. (1) 10.9+ First Amendment to Manufacturing Agreement, dated November 21, 1996, by and between Lonza Biologics PLC and the Registrant. (1) 10.10+ Development Agreement, dated November 15, 1995, by and between MDS Nordion Inc. and the Registrant. (1) 10.11+ Patent License Agreement, dated March 15, 1996, by and between the Region Wallone, the Universite Catholique de Louvain and Coulter Pharma Belgium, SA. (3) 10.12+ Second Amendment to Manufacturing Agreement, dated June 30, 1997, by and between Lonza Biologics PLC and the Registrant. (4) 10.13+ Third Amendment to Manufacturing Agreement, date September 26, 1997, by and between Lonza Biologics PLC and the Registrant. (4) 10.14+ Fourth Amendment to Manufacturing Agreement, dated September 17, 1997, by and between Lonza Biologics PLC and the Registrant (5) 10.15+ Contract Research and Development Agreement, dated October 22, 1997, by and between Dr. Karl Thomae GmbH and the Registrant (5) 10.16+ Fifth Amendment to Manufacturing Agreement, dated October 27, 1997, by and between Lonza Biologics PLC and the Registrant. (5) 10.17+ Lease Agreement, dated November 7, 1997, by and between HMS Gateway Office L.P. and the Registrant. (6) 10.18+ Commercial Supply Agreement, dated May 28, 1998 by and between Lonza Biologics PLC and the Registrant. (7) 10.19+ Supply agreement, dated August 31, 1998 by and between MDS Nordion, Inc. and the Registrant
61 62
EXHIBIT EXHIBIT FOOTNOTE NUMBER DESCRIPTION OF DOCUMENT - -------- ------- ----------------------- (7) 10.20+ Facilities agreement, dated August 31, 1998 by and between MDS Nordion, Inc. and the Registrant 10.21+ Stock Purchase Agreement, dated October 23, 1998, by and between SmithKline Beecham Corporation and the Registrant 10.22+ Security Agreement, dated October 23, 1998, by and between SmithKline Beecham Corporation and the Registrant 10.23+ Grant of Security Interest, dated October 23, 1998, by and between SmithKline Beecham Corporation and the Registrant 10.24+ Loan Agreement, dated October 23, 1998, by and between SmithKline Beecham Corporation and the Registrant 10.25+ Collaboration Agreement, dated October 23, 1998, by and between SmithKline Beecham Corporation and the Registrant 10.26+ Supply Agreement, dated November 3, 1998, by and between Boehringer Ingelheim Pharma KG and the Registrant 10.27+ First Amendment to Lease Agreement, dated November 10, 1998, by and between HMS Gateway Office L.P. and the Registrant. 10.28+ Amendment #1 to the Collaboration Agreement, dated November 30, 1998 by and between SmithKline Beecham Corporation and the Registrant. 10.29+ Loan and Security Agreement, dated October 29, 1998, by and between Silicon Valley bank and the Registrant. (1) 21.1 Subsidiaries of the Registrant. 23.1 Consent of Ernst & Young LLP, Independent Auditors 27.1 Financial Data Schedule
- --------------- (1) Incorporated by reference to the indicated exhibit in the Company's Registration Statement on Form S-1 (File No. 333-17661), as amended. (2) Filed as an exhibit to the Registrant's Registration Statement on Form S-8 (No. 333-23265) and incorporated herein by reference. (3) Filed as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 1997 and incorporated herein by reference. (4) Filed as an exhibit to the Registrant's Special Report on Form 8-K filed September 29, 1997 and incorporated herein by reference. (5) Filed as an exhibit to the Registrant's Annual Report on Form 10-K for the year ended December 31, 1997 and incorporated herein by reference. (6) Filed as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 1998 and incorporated herein by reference. (7) Filed as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 1998 and incorporated herein by reference. + Portions omitted pursuant to a request of confidentiality filed separately with the Commission. 62
EX-10.21 2 STOCK PURCHASE AGREEMENT W/SMITHKLINE BEECHAM 1 Exhibit 10.21 ***Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R.Sections 200.80(b)(4), 200.83 and 240.24b-2 STOCK PURCHASE AGREEMENT COULTER PHARMACEUTICAL, INC. OCTOBER 23, 1998 2 TABLE OF CONTENTS
PAGE 1. PURCHASE AND SALE .......................................................... 1 1.1 Sale of Shares .................................................... 1 1.2 Closing Date ...................................................... 1 1.3 Delivery .......................................................... 1 1.4 Rule 144 Reporting ................................................ 2 1.5 "Market Stand-Off" Agreements ..................................... 2 1.6 Standstill Covenant ............................................... 2 2. REPRESENTATIONS AND WARRANTIES OF COULTER .................................. 2 2.1 Organization and Standing; Certificate and Bylaws ................. 2 2.2 Authorization ..................................................... 3 2.3 Validity of Shares ................................................ 3 2.4 Offering .......................................................... 3 2.5 Full Disclosure ................................................... 3 2.6 No Conflict; No Violation ......................................... 3 2.7 Consents and Approvals ............................................ 4 2.8 Absence of Certain Developments ................................... 4 3. REPRESENTATIONS AND WARRANTIES OF SB ....................................... 4 3.1 Legal Power ....................................................... 4 3.2 Due Execution ..................................................... 4 3.3 Investment Representations ........................................ 4 4. CONDITIONS TO CLOSING ...................................................... 5 4.1 Conditions to Obligations of SB ................................... 5 4.2 Conditions to Obligations of Coulter .............................. 6 5. MISCELLANEOUS .............................................................. 7 5.1 Governing Law ..................................................... 7 5.2 Successors and Assigns ............................................ 7 5.3 Entire Agreement .................................................. 7 5.4 Severability ...................................................... 7 5.5 Amendment and Waiver .............................................. 7 5.6 Delays or Omissions ............................................... 7
i. 3 TABLE OF CONTENTS (CONTINUED)
PAGE 5.7 Notices, etc. ..................................................... 7 5.8 Finder's Fees ..................................................... 9 5.9 Information Confidential .......................................... 9 5.10 Titles and Subtitles .............................................. 9 5.11 Counterparts ...................................................... 9
ii. 4 STOCK PURCHASE AGREEMENT THIS STOCK PURCHASE AGREEMENT (the "Agreement") is made and entered into as of October 23, 1998 (the "Effective Date"), by and between COULTER PHARMACEUTICAL, INC., a Delaware corporation ("Coulter"), and SMITHKLINE BEECHAM CORPORATION, a Pennsylvania corporation ("SB"). RECITALS A. Coulter and SB are entering into that certain Collaboration Agreement dated as of the Effective Date of this Agreement (the "Collaboration Agreement"). B. In connection with entry into the Collaboration Agreement, Coulter desires to sell and issue to SB, and SB desires to buy, shares of Coulter's common stock, as provided herein. NOW, THEREFORE, the Parties hereto agree as follows: 1. PURCHASE AND SALE. Subject to the terms and conditions hereof, and in reliance upon the representations, warranties and agreements contained herein, Coulter hereby agrees to issue and sell to SB, and SB hereby agrees to purchase from Coulter, the aggregate number of shares of Coulter's Common Stock (the "Shares") determined in accordance with Section 1.1 hereof. 1.1 SALE OF SHARES. On the Closing Date (as defined in Section 1.2), Coulter shall issue and sell to SB, and SB shall purchase from Coulter the number of shares of Coulter's Common Stock (the "Shares") equal to the quotient of $7,250,000 divided by the Purchase Price (as hereinafter defined). In the event the number of Shares includes a fraction of a share, the number of Shares shall be increased to the nearest whole number of shares and the aggregate Purchase Price shall be increased to equal the Purchase Price times such whole number of Shares. The Purchase Price shall be one hundred twenty-five percent (125%) of the average of the closing prices of Coulter's Common Stock on the Nasdaq National Market, as reported by the Wall Street Journal, Western Edition (the "Wall Street Journal"), for the twenty (20) trading days prior to the Effective Date. 1.2 CLOSING DATE. The closing of the sale and purchase of the Shares (the "Closing") shall take place on the date (the "Closing Date") that is five (5) business days after the date on which the Collaboration Agreement becomes effective in accordance with Section 19 of the Collaboration Agreement. 1.3 DELIVERY. At the Closing, Coulter will deliver to SB a certificate registered in the name of SB, representing the Shares to be purchased by SB from Coulter, dated the Closing Date, against payment of the aggregate Purchase Price by wire transfer, a check made payable to the order of Coulter, or any combination thereof. 1. 5 1.4 RULE 144 REPORTING. With a view to making available to SB the benefits of certain rules and regulations of the Securities and Exchange Commission (the "SEC") which may permit the sale of the Shares to the public without registration, Coulter agrees to use its best efforts to: (a) Make and keep public information available, as those terms are understood and defined in Rule 144 ("Rule 144") under the Securities Act of 1933, as amended (the 1933 Act") or any similar or analogous rule promulgated under the 1933 Act, as long as the Shares are outstanding; (b) File with the SEC, in a timely manner, all reports and other documents required of Coulter under the 1933 Act and the Securities Exchange Act of 1934, as amended (the "1934 Act"); (c) Take all such action (including without limitation the furnishing of the information described in Rule 144(d)(4)) as may be necessary to facilitate a sale of the shares by SB to a "qualified institutional buyer," as such term is defined in Rule 144A of the 1933 Act. 1.5 "MARKET STAND-OFF" AGREEMENTS. SB hereby agrees that prior to the second anniversary of the Closing Date it shall not sell or otherwise transfer or dispose of any of the Shares held by it. Coulter may impose stop-transfer instructions with respect to securities subject to the foregoing restriction until the expiration thereof. Following the second anniversary of the Closing Date, until termination of the Collaboration Agreement, if SB desires to sell or otherwise transfer any Shares, then SB shall first give [...***...] written notice thereof to Coulter, describing generally the basis upon which SB proposes to sell or otherwise transfer or dispose of such Shares. 1.6 STANDSTILL COVENANT. Other than the purchase of the Shares contemplated by Section 1 of this Agreement, SB agrees that, during the term of the Collaboration Agreement and for one year thereafter (for two years thereafter in the event such agreement is terminated prior to the eighth anniversary of the Effective Date), neither SB nor any of its affiliates will in any manner, directly or indirectly, without the written consent of the Company effect, propose to effect or actively and consciously participate as a partner in (a) any acquisition of any securities or assets of Coulter or (b) any tender or exchange offer, merger, business combination, recapitalization or other extraordinary transaction involving Coulter. 2. REPRESENTATIONS AND WARRANTIES OF COULTER. Except as otherwise set forth on the Schedule of Exceptions attached hereto as Exhibit A, which shall contain Section numbers specifically corresponding to the Section numbers in this Agreement, Coulter hereby represents and warrants to SB as follows: 2.1 ORGANIZATION AND STANDING; CERTIFICATE AND BYLAWS. Coulter is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware, and has full power and authority to own and operate its properties and assets and to carry on its business as presently conducted and as proposed to be conducted. Coulter is qualified as a * CONFIDENTIAL TREATMENT REQUESTED 2. 6 foreign corporation to do business in each jurisdiction in the United States in which the ownership of its property or the conduct of its business requires such qualification, except where any statutory fines or penalties or any corporate disability imposed for the failure to qualify would not materially adversely affect Coulter, its assets, financial condition or operations. True and correct copies of Coulter's Restated Certificate of Incorporation and Bylaws currently in effect have been delivered to SB. 2.2 AUTHORIZATION. All corporate action on the part of Coulter, its officers, directors and stockholders necessary for the authorization, execution and delivery of this Agreement, the performance of all Coulter's obligations hereunder, and for the authorization, issuance, sale and delivery of the Shares has been taken or will be taken prior to Closing. This Agreement, when executed and delivered, shall constitute a valid and legally binding obligation of Coulter in accordance with its terms, subject to laws of general application relating to bankruptcy, insolvency and the relief of debtors, and subject to general equity principles. 2.3 VALIDITY OF SHARES. The sale of the Shares is not subject to any preemptive rights or rights of first refusal that have not been waived and, when issued, sold and delivered in compliance with the provisions of this Agreement, the Shares will be validly issued, fully paid and nonassessable, and will be free of any liens or encumbrances created by Coulter; provided, however, that the Shares may be subject to restrictions on transfer under state and/or federal securities laws as set forth herein or as otherwise required by such laws at the time a transfer is proposed. 2.4 OFFERING. Assuming the accuracy of the representations and warranties of SB contained in Section 3 hereof, the offer, issue, and sale of Shares are exempt from the registration and prospectus delivery requirements of the 1933 Act, and the Shares have been registered or qualified (or are exempt from registration and qualification) under the registration, permit, or qualification requirements of all applicable state securities laws. 2.5 FULL DISCLOSURE. (a) As of the Closing, Coulter will have furnished to SB the following documents, and the information contained in such documents, as of their respective dates (or if amended, as of the date of such amendment), will not contain any untrue statement of a material fact, and will not omit to state any material fact necessary to make any statement, in light of the circumstances under which such statement was made, not misleading: Coulter's Registration Statement on Form S-3, effective July 31, 1998, Coulter's annual report on Form 10-K for the fiscal year ended December 31, 1997, Coulter's Quarterly Reports on Form 10-Q for the quarters ended March 31 and June 30, 1998, and any additional Quarterly Reports on Form 10-Q or Current Reports on Form 8-K filed after the Effective Date but prior to the Closing. 2.6 NO CONFLICT; NO VIOLATION. The execution, delivery and performance of this Agreement and consummation of the transactions contemplated hereby will not (a) conflict with any provisions of the Restated Certificate of Incorporation or Bylaws of Coulter; (b) result in any material violation or default of, or permit the acceleration of any obligation under (in each case, 3. 7 upon the giving of notice, the passage of time, or both), any material mortgage, indenture, lease, agreement or other instrument, permit, franchise, license, judgment, order, decree, law, ordinance, rule or regulation applicable to Coulter or its properties. 2.7 CONSENTS AND APPROVALS. All consents, approvals, orders, or authorizations of, or registrations, qualifications, designations, declarations, or filings with, any governmental authority, required on the part of Coulter in connection with the valid execution and delivery of this Agreement, the offer, sale or issuance of the Shares, or the consummation of any other transaction contemplated hereby have been obtained, or will be effective at the Closing, except for notices required or permitted to be filed with certain state and federal securities commissions after the Closing, which notices will be filed on a timely basis. 2.8 ABSENCE OF CERTAIN DEVELOPMENTS. With respect to the Closing, since June 30, 1998, Coulter has not (a) incurred or become subject to any material liabilities (absolute or contingent) except current liabilities incurred, and liabilities under contracts entered into, in the ordinary course of business, consistent with past practices; (b) mortgaged, pledged or subjected to lien, charge or any other encumbrance any of its assets, tangible or intangible; (c) sold, assigned or transferred any of its assets or canceled any debts or obligations except in the ordinary course of business, consistent with past practices; (d) suffered any extraordinary losses, or waived any rights of substantial value; (e) entered into any material transaction other than in the ordinary course of business, consistent with past practices; or (f) otherwise had any material change in its condition, financial or otherwise, except for changes in the ordinary course of business, consistent with past practices, none of which individually or in the aggregate has been materially adverse to Coulter. 3. REPRESENTATIONS AND WARRANTIES OF SB. SB hereby represents and warrants to Coulter as follows: 3.1 LEGAL POWER. It has the requisite legal power to enter into this Agreement, to purchase the Shares hereunder, and to carry out and perform its obligations under the terms of this Agreement. 3.2 DUE EXECUTION. This Agreement has been duly authorized, executed and delivered by it, and, upon due execution and delivery by Coulter, this Agreement will be a valid and binding agreement of it. 3.3 INVESTMENT REPRESENTATIONS. (a) It is acquiring the Shares for its own account, not as nominee or agent, for investment and not with a view to, or for resale in connection with, any distribution or public offering thereof within the meaning of the 1933 Act. (b) It understands that (i) the Shares have not been registered under the 1933 Act by reason of a specific exemption therefrom, that they must be held by it indefinitely, and that it must, therefore, bear the economic risk of such investment indefinitely, unless a subsequent disposition thereof is registered under the 1933 Act or is exempt from such 4. 8 registration; (ii) each certificate representing the Shares will be endorsed with the following legend: "THE SECURITIES EVIDENCED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND MAY NOT BE SOLD, TRANSFERRED, ASSIGNED OR HYPOTHECATED UNLESS (A) PURSUANT TO SEC RULE 144 OR (B) THERE IS AN EFFECTIVE REGISTRATION STATEMENT UNDER THE 1933 ACT COVERING SUCH SECURITIES OR (C) COULTER RECEIVES AN OPINION OF COUNSEL FOR THE HOLDER OF THESE SECURITIES REASONABLY SATISFACTORY TO COULTER, STATING THAT SUCH SALE, TRANSFER, ASSIGNMENT OR HYPOTHECATION IS EXEMPT FROM THE REGISTRATION AND PROSPECTUS DELIVERY REQUIREMENTS OF THE 1933 ACT." and (iii) Coulter will instruct any transfer agent not to register the transfer of any of the Shares unless the conditions specified in the foregoing legend are satisfied. SB shall have the right to demand removal of the foregoing legend with respect to any or all of the Shares if, in the opinion of counsel to Coulter, removal of such legend is permitted by the rules and regulations of the SEC. (c) It has been furnished with such materials and has been given access to such information relating to Coulter as it or its qualified representative has requested and it has been afforded the opportunity to ask questions regarding Coulter and the Shares, all as it has found necessary to make an informed investment decision. (d) It is an "accredited investor" within the meaning of Regulation D under the 1933 Act. (e) It was not formed for the specific purpose of acquiring the Shares offered hereunder. 4. CONDITIONS TO CLOSING. 4.1 CONDITIONS TO OBLIGATIONS OF SB. SB's obligation to purchase the Shares at the Closing is subject to the fulfillment, at or prior to the Closing, of all of the following conditions: (a) REPRESENTATIONS AND WARRANTIES TRUE; PERFORMANCE OF OBLIGATIONS. The representations and warranties made by Coulter in Section 2 hereof shall be true and correct in all material respects on the date of the Closing with the same force and effect as if they had been made on and as of said date; and Coulter shall have performed all obligations and conditions herein required to be performed by it on or prior to the Closing. (b) OPINION OF COULTER'S COUNSEL. SB shall have received from Cooley Godward LLP, counsel to Coulter, an opinion letter substantially in the form attached hereto as Exhibit B, addressed to it, dated the Closing Date. 5. 9 (c) PROCEEDINGS AND DOCUMENTS. All corporate and other proceedings in connection with the transactions contemplated at the Closing hereby and all documents and instruments incident to such transactions shall be reasonably satisfactory in substance and form to SB and its special counsel, and SB and its special counsel shall have received all such counterpart originals or certified or other copies of such documents as they may reasonably request. (d) QUALIFICATIONS, LEGAL INVESTMENT. All authorizations, approvals, or permits, if any, of any governmental authority or regulatory body of the United States or of any state that are required in connection with the lawful sale and issuance of the Shares pursuant to this Agreement shall have been duly obtained and shall be effective on and as of the Closing. No stop order or other order enjoining the sale of the Shares shall have been issued and no proceedings for such purpose shall be pending or, to the knowledge of Coulter, threatened by the SEC or any commissioner of corporations or similar officer of any other state having jurisdiction over this transaction. At the time of the Closing, the sale and issuance of the Shares shall be legally permitted by all laws and regulations to which SB and Coulter are subject. (e) COMPLIANCE CERTIFICATE. Coulter shall have delivered to SB a Certificate, executed by the President of Coulter, dated the date of the Closing, certifying to the fulfillment of the conditions specified in subparagraphs (a) and (d) of this Subsection 4.1. 4.2 CONDITIONS TO OBLIGATIONS OF COULTER. Coulter's obligation to issue and sell the Shares at the Closing is subject to the fulfillment to Coulter's satisfaction, on or prior to the Closing, of the following conditions: (a) REPRESENTATIONS AND WARRANTIES TRUE. The representations and warranties made by SB in Section 3 hereof shall be true and correct at the date of the Closing, with the same force and effect as if they had been made on and as of said date. (b) PERFORMANCE OF OBLIGATIONS. SB shall have performed and complied with all agreements and conditions herein required to be performed or complied with by it on or before the Closing. (c) QUALIFICATIONS, LEGAL INVESTMENT. All authorizations, approvals, or permits, if any, of any governmental authority or regulatory body of the United States or of any state that are required in connection with the lawful sale and issuance of the Shares pursuant to this Agreement shall have been duly obtained and shall be effective on and as of the Closing. No stop order or other order enjoining the sale of the Shares shall have been issued and no proceedings for such purpose shall be pending or, to the knowledge of Coulter, threatened by the SEC or any commissioner of corporations or similar officer of any state having jurisdiction over this transaction. At the time of the Closing, the sale and issuance of the Shares shall be legally permitted by all laws and regulations to which SB and Coulter are subject. (d) COMPLIANCE CERTIFICATE. SB shall have delivered to Coulter a Certificate, executed by the President of SB, dated the date of the Closing, certifying to the fulfillment of the conditions specified in subparagraphs (a) and (c) of this Subsection 4.2. 6. 10 5. MISCELLANEOUS. 5.1 GOVERNING LAW. This Agreement shall be governed by and construed under the laws of the State of Delaware as applied to agreements among Delaware residents, made and to be performed entirely within the State of Delaware. 5.2 SUCCESSORS AND ASSIGNS. Except as otherwise expressly provided herein, the provisions hereof shall inure to the benefit of, and be binding upon, the successors, assigns, heirs, executors, and administrators of the parties hereto. 5.3 ENTIRE AGREEMENT. This Agreement, the Collaboration Agreement, the Loan Agreements (as defined in the Collaboration Agreement) and the Exhibits hereto and thereto, and the other documents delivered pursuant hereto and thereto constitute the full and entire understanding and agreement among the parties with regard to the subjects hereof, and no party shall be liable or bound to any other party in any manner by any representations, warranties, covenants, or agreements except as specifically set forth herein or therein. Nothing in this Agreement, express or implied, is intended to confer upon any party, other than the parties hereto and their respective successors and assigns, any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided herein. 5.4 SEVERABILITY. In case any provision of this Agreement shall be invalid, illegal, or unenforceable, it shall, to the extent practicable, be modified so as to make it valid, legal and enforceable and to retain as nearly as practicable the intent of the parties, and the validity, legality, and enforceability of the remaining provisions shall not in any way be affected or impaired thereby. 5.5 AMENDMENT AND WAIVER. Any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance, either retroactively or prospectively, and either for a specified period of time or indefinitely), with the written consent of Coulter and SB. Any amendment or waiver effected in accordance with this Section shall be binding upon SB, each future holder of the Shares, and Coulter. 5.6 DELAYS OR OMISSIONS. No delay or omission to exercise any right, power, or remedy accruing to SB or any subsequent holder of any Shares upon any breach, default or noncompliance of Coulter under this Agreement, shall impair any such right, power, or remedy, nor shall it be construed to be a waiver of any such breach, default or noncompliance, or any acquiescence therein, or of any similar breach, default or noncompliance thereafter occurring. It is further agreed that any waiver, permit, consent, or approval of any kind or character on SB's part of any breach, default or noncompliance under this Agreement or any waiver on SB's part of any provisions or conditions of this Agreement must be in writing and shall be effective only to the extent specifically set forth in such writing, and that all remedies, either under this Agreement, by law, or otherwise afforded to SB, shall be cumulative and not alternative. 5.7 NOTICES, ETC. All notices and other communications required or permitted hereunder shall be in writing and shall be deemed effectively given (a) upon personal delivery, (b) on report of successful transmission by facsimile machine that automatically generates a 7. 11 printed report indicating whether transmission was completed successfully, at the conclusion of each transmission, (c) on the first business day after receipted delivery to a courier service which guarantees next business-day delivery, under circumstances in which such guaranty is applicable, or (d) on the earlier of delivery or five (5) business days after mailing by United States certified by mail, postage and fees prepaid, to the appropriate party at the address set forth below or to such other address as the part so notifies the other in writing: (a) if to Coulter, to: COULTER PHARMACEUTICAL, INC. 550 California Avenue, Suite 200 Palo Alto, CA 94306 Facsimile: (650) 842-7303 Attention: President and Chief Executive Officer with a copy to: COOLEY GODWARD LLP 5 Palo Alto Square, 4th Floor 3000 El Camino Real Palo Alto, CA 94306-2155 Facsimile: (650) 857-0663 Attention: James C. Kitch, Esq. (b) if to SB, to: SmithKline Beecham Corporation One Franklin Plaza (Mail Code FP1930) P.O. Box 7929 Philadelphia, Pennsylvania 19101 Attention: Senior Vice President, Business Development With copies to: SmithKline Beecham Corporation One Franklin Plaza (Mail Code FP2355/DP) Philadelphia, Pennsylvania 19102 Attention: Donald F. Parman Facsimile: (215) 751-5349 Notwithstanding the foregoing, all notices and other communications to an address outside of the United States shall be sent by telecopy and confirmed in writing to be sent by first class mail. 8. 12 5.8 FINDER'S FEES. (a) Coulter (i) represents and warrants that it has retained no finder or broker in connection with the transactions contemplated by this Agreement and (ii) hereby agrees to indemnify and to hold SB harmless of and from any liability for any commission or compensation in the nature of a finder's fee to any broker or other person or firm (and the costs and expenses of defending against such liability or asserted liability) for which Coulter or any of its employees or representatives is responsible. (b) SB (i) represents and warrants that it has retained no finder or broker in connection with the transactions contemplated by this Agreement, and (ii) hereby agrees to indemnify and to hold Coulter harmless of and from any liability for any commission or compensation in the nature of a finder's fee to any broker or other person or firm (and the costs and expenses of defending against such liability or asserted liability) for which SB or any of its employees or representatives are responsible. 5.9 INFORMATION CONFIDENTIAL. SB acknowledges that any non public information received by it pursuant hereto is confidential and for SB's use only, and it will refrain from using such information or reproducing, disclosing, or disseminating such information to any other person (other than its employees, affiliates, agents, or partners having a need to know the contents of such information and its attorneys, in each case who agree to be bound by this Section 5.9), except in connection with the exercise of rights under this Agreement, unless such information becomes available to the public generally or it is required by a governmental body to disclose such information. 5.10 TITLES AND SUBTITLES. The titles of the sections and subsections of this Agreement are for convenience of reference only and are not to be considered in construing this Agreement. 5.11 COUNTERPARTS. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, but all of which together shall constitute one instrument. The foregoing Agreement is hereby executed as of the date first above written. COULTER PHARMACEUTICAL, INC. SMITHKLINE BEECHAM CORPORATION By: By: --------------------------------- --------------------------------- Printed Name: Printed Name: ----------------------- ----------------------- Title: Title: ------------------------------ ------------------------------ 9. 13 LIST OF EXHIBITS EXHIBITS Exhibit A - SCHEDULE OF EXCEPTIONS Exhibit B - OPINION OF COMPANY'S COUNSEL 1. 14 EXHIBIT A SCHEDULE OF EXCEPTIONS None 1. 15 EXHIBIT B OPINION OF COMPANY'S COUNSEL 1.
EX-10.22 3 SECURITY AGREEMENT W/ SMITHKLINE BEECHAM 1 EXHIBIT 10.22 *** TEXT OMITTED AND FILED SEPARATELY CONFIDENTIAL TREATMENT REQUESTED UNER 17C.F.R.SECTIONS 200.80(b)(4), 200.83 AND 240.24b-2 SECURITY AGREEMENT THIS SECURITY AGREEMENT dated as of October 23, 1998 ("SECURITY AGREEMENT"), is made by COULTER PHARMACEUTICAL, INC., a corporation formed under the laws of the State of Delaware, with its principal place of business at 550 California Avenue, Suite 200, Palo Alto, California 94306, USA ("GRANTOR"), in favor of SMITHKLINE BEECHAM CORPORATION, with its principal place of business at One Franklin Plaza, Philadelphia, Pennsylvania 19101, USA ("SECURED PARTY"). This Security Agreement shall not be effective until the Collaboration Agreement Effective Date. RECITALS A. Pursuant to that certain Loan Agreement dated as of even date herewith by and between Grantor and Secured Party (as the same may from time to time be amended, modified, supplemented or restated, the "LOAN AGREEMENT"), Secured Party has agreed to make certain advances of money and to extend certain financial accommodation to Grantor in the amounts and manner set forth in the Agreement (collectively, the "LOANS"). B. Secured Party is willing to make the Loans to Grantor, but only upon the condition, among others, that Grantor shall have executed and delivered to Secured Party this Security Agreement. AGREEMENT NOW, THEREFORE, in order to induce Secured Party to make the Loans and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, and intending to be legally bound, Grantor hereby represents, warrants, covenants and agrees as follows: 1. DEFINED TERMS. When used in this Security Agreement the following terms shall have the following meanings (such meanings being equally applicable to both the singular and plural forms of the terms defined): "004 TRIAL" means Grantor's clinical trial with Protocol No. RIT-II-004 ("Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy-Refractory Low-Grade B-Cell Lymphomas and Low-Grade Lymphomas That Have Transformed to Higher Grade Histologies") for which enrollment and interim analysis was completed prior to the date first written above. 1. 2 "AFFILIATE" means, in the case of either Grantor or Secured Party, any corporation, joint venture, or other business entity which directly or indirectly controls, is controlled by, or is under common control with that Party. "Control," as used in this Section, shall mean having the power to direct, or cause the direction of, the management and policies of an entity, whether through ownership of voting securities, by contract or otherwise. "ANTI-CD20 ANTIBODY" means: (i) the B1 Murine Antibody or any derivative of the B1 Murine Antibody, including without limitation, any genetically engineered construct of the B1 Murine Antibody; (ii) any other anti-CD20 monoclonal antibody other than the B1 Murine Antibody including, without limitation, human, humanized, primatized, or chimerized antibody; (iii) any [...***...] of (i) or (ii), (iv) any [...***...] of (i) or (ii); (v) any [...***...] of (i) or (ii); (vi) any [...***...] of (i) or (ii); (vii) any [...***...]. "BEXXAR" means B1 Murine Antibody conjugated with 131Iodine or unconjugated, depending upon context. "B1 MURINE ANTIBODY" means the unconjugated IgG2a anti-CD20 murine monoclonal antibody which is one of the active agents tested in the 004 Trial. "COLLABORATION AGREEMENT" means that certain Collaboration Agreement entered into as of the same day as this Security Agreement, between Coulter Pharmaceutical, Inc. and SmithKline Beecham Corporation relating to Bexxar. "COLLABORATION AGREEMENT EFFECTIVE DATE" has the meaning set forth in the Collaboration Agreement for the term "Effective Date." "COLLATERAL" has the meaning assigned to such term in Section 2 of this Security Agreement. "CURE DATE" means the date upon which Grantor cures its failure to maintain a financial covenant set forth in Section 8 of the Loan Agreement. "EFFECTIVE DATE" means the date upon which Grantor fails to maintain a financial covenant set forth in Section 8 of the Loan Agreement. *CONFIDENTIAL TREATMENT REQUESTED 3 "EVENT OF DEFAULT" means (i) any failure by Grantor forthwith to pay or perform any of the Secured Obligations and (ii) any "Event of Default" as defined in the Loan Agreement. "INVENTION" means an invention conceived or reduced to practice in the course of or as a result of the performance of the Collaboration Agreement by an employee or agent of Grantor. "KNOW-HOW" means all know-how, including development, manufacture development and commercialization data, processes and information, including any copyright relating thereto, owned or controlled by Grantor as of the date first written above or acquired during the term of this Security Agreement relating to: (b) Anti-CD20 Antibody, including any Licensed Compound or Licensed Product; (c) any component of (a); (d) any intermediate in the making of any of (a) or (b); (e) methods of making any of (a), (b) or (c); (f) any method of using any of (a), (b), or (c); (g) any use of (a); (h) any formulation or delivery system for (a); and/or (i) any other data related to the development, manufacture, marketing or sale of (a). "LICENSED COMPOUND" means Bexxar and any Second Generation Licensed Compounds. "LICENSED PATENTS" means all patents or patent applications, throughout the Territory and all divisionals, continuations, continuations-in-part, reissues, extensions, supplementary protection certificates thereof, owned or controlled by Grantor and existing as of the date first written above or filed or issuing during the term of this Security Agreement, at least one claim of which covers: (j) an Anti-CD20 Antibody, including any Licensed Compound or Licensed Product; (k) any component of (a); (l) any intermediate in the making of any of (a) or (b); (m) methods of making any of (a), (b) or (c); 4 (n) any method of using any of (a), (b), or (c); (o) any use of (a); (p) any formulation or delivery system for (a); and/or (q) any other Invention related to the development, manufacture, use or sale of (a). "LICENSED PRODUCT" means any pharmaceutical product containing a Licensed Compound in any formulation or mode of administration. "LIEN" means any mortgage, lien, deed of trust, charge, pledge, security interest or other encumbrance. "NORDION KANATA FACILITY" has the meaning assigned to such term in Section 9.10.1 of the Collaboration Agreement. "PERMITTED LIEN" means: (a) any Liens existing on the date of this Security Agreement or anticipated and set forth on Schedule A attached hereto; (b) Liens for taxes, fees, assessments or other governmental charges or levies, either not delinquent or being contested in good faith by appropriate proceedings; (c) Liens (i) upon or in [...***...] (other than the [...***...] in [...***...] hereof) [...***...] to secure [...***...] of such [...***...] or [...***...] solely for the purpose of [...***...] or (ii) existing [...***...] at the time of [...***...], provided that [...***...] is [...***...] to [...***...], [...***...] thereon and the [...***...] of [...***...]; (d) leases or subleases and licenses or sublicenses granted to others in the ordinary course of Grantor's business not interfering in any material respect with the business of Grantor; (e) Liens securing claims or demands of materialmen, mechanics, carriers, warehousemen, landlords and other like persons or entities imposed without action of such parties, provided that the payment thereof is not yet required; (f) Liens incurred or deposits made in the ordinary course of Grantor's business in connection with worker's compensation, unemployment insurance, social security and other like laws; (g) Liens arising from judgments, decrees or attachments not constituting an Event of Default; (h) easements, reservations, rights-of-way, restrictions, minor defects or irregularities in title and other similar Liens affecting real property not interfering in any material respect with the ordinary conduct of the business of Grantor; (i) Liens in favor of customs and revenue authorities arising as a matter of law to secure payment of customs duties in connection with the importation of goods; (j) Liens which constitute setoff rights of a customary nature; (k) Liens [...***...] on [...***...] subject to [...***...] including [...***...] otherwise [...***...] and Liens [...***...] pursuant to [...***...] in the [...***...] (including [...***...] and [...***...]), all [...***...] for the purpose of [...***...] of [...***...] (including Liens arising from [...***...]; and (l) Liens incurred in connection with 5 the extension, renewal or refinancing of the indebtedness secured by Liens of the type described above, provided that any extension, renewal or replacement Lien shall be limited to the property encumbered by the existing Lien and the principal amount of the indebtedness being extended, renewed or refinanced does not increase. "PRODUCT ACCOUNTS" has the meaning set forth in Section 2(a)(iii) below. "RETURN LICENSE" has the meaning set forth in Section 3 below. "SECOND GENERATION ANTIBODY CANDIDATE" means: (i) any derivative of the B1 Murine Antibody, including without limitation, any genetically engineered construct of the B1 Murine Antibody; (ii) any other anti-CD20 monoclonal antibody other than the B1 Murine Antibody including, without limitation, human, humanized, primatized, or chimerized antibody, (iii) any [...***...] of (i) or (ii), (iv) any [...***...] (i) or (ii), (v) any [...***...] of (i) or (ii), (vi) any [...***...] of (i) or (ii), (vii) any [...***...] of (i) or (ii), or (viii) any [...***...]. "SECOND GENERATION LICENSED COMPOUND" means a Second Generation Licensed Compound Candidate (i) for which an SB Option Exercise Notice has been provided pursuant to Section 4.2.2(a) of the Collaboration Agreement or (ii) which has become a Second Generation Licensed Compound in accordance with Section 4.2.4(a)-(b) of the Collaboration Agreement. "SECOND GENERATION LICENSED COMPOUND CANDIDATE" means (i) an unconjugated Second Generation Antibody Candidate; (ii) B1 Murine Antibody conjugated to [...***...]; (iii) a Second Generation Antibody Candidate conjugated to [...***...]; or (iv) a Second Generation Antibody Candidate conjugated to [...***...]. "SECURED OBLIGATIONS" means (a) the obligation of Grantor to repay Secured Party all of the unpaid principal amount of, and accrued interest on (including any interest that accrues after the commencement of bankruptcy), the Loans in accordance with the terms of the Loan Agreement, and (b) the obligation of Grantor to pay any fees, costs and expenses of the Secured Party under the Loan Agreement and under Section 6(c) hereof. *CONFIDENTIAL TREATMENT REQUESTED 6 "TERRITORY" means all countries and territories of the world except for Japan. "TRANSFEREE" has the meaning set forth in Section 3 below. "UCC" means the Uniform Commercial Code as the same may, from time to time, be in effect in the State of California; provided, however, in the event that, by reason of mandatory provisions of law, any or all of the attachment, perfection or priority of Secured Party's security interest in any Collateral is governed by the Uniform Commercial Code as in effect in a jurisdiction other than the State of California, the term "UCC" shall mean the Uniform Commercial Code as in effect in such other jurisdiction for purposes of the provisions hereof relating to such attachment, perfection of priority and for purposes of definitions related to such provisions. In addition, the following terms shall be defined terms having the meaning set forth for such terms in the UCC (definition sections of the UCC are noted parenthetically): "Accounts" (9106); "Equipment" (9109(2)); "Proceeds" (9306(1)). Each of the foregoing defined terms shall include all of such items now owned, or hereafter acquired, by Grantor. All capitalized terms used herein and not otherwise defined herein shall have the respective meanings given to them in the Loan Agreement. 2. GRANT OF SECURITY INTEREST. (a) As collateral security for the prompt and complete payment and performance when due (whether at stated maturity, by acceleration or otherwise) of all the Secured Obligations and in order to induce Secured Party to cause the Loans to be made, Grantor hereby assigns, conveys, mortgages, pledges, hypothecates and transfers (and shall cause any of its present and future Affiliates to assign, convey, mortgage, pledge, hypothecate and transfer) to Secured Party, and hereby grants to Secured Party, a security interest in all of Grantor's right, title and interest in, to and under the following (all of which being collectively referred to herein as the "COLLATERAL"): (i) The Licensed Patents and Know-How. The Licensed Patents in existence as of the date first written above are specifically listed on Schedule C. Schedule C shall be updated by the Grantor on a semi-annual basis; (ii) All Equipment of Grantor located at, and relating to, Grantor's second radiolabeling site to be located in North America; provided that if the second radiolabeling site is the Nordion Kanata Facility, then only such Equipment acquired in connection with the second radiolabeling site shall be within the scope of the term Equipment as used in this Section 2(a)(ii); 7 (iii) All Accounts of Grantor relating to the Licensed Compounds or Licensed Products pursuant to the Collaboration Agreement and not previously remitted to Grantor pursuant to Section 3.2.6, Section 3.3.3 and Section 7.1.14 of the Collaboration Agreement as well as any other payments owed to Grantor by Secured Party under the Collaboration Agreement which have not been previously remitted to Grantor (the "PRODUCT ACCOUNTS"); and (iv) To the extent not otherwise included, all Proceeds of each of the foregoing and all accessions to, substitutions and replacements for and rents, profits and products of each of the foregoing. (b) Notwithstanding anything contained in this Security Agreement to the contrary, the grant of security interest in the Licensed Patents and Know-How shall be subject to the Return License granted by Secured Party to Grantor pursuant to Section 3 below. (c) Notwithstanding anything contained in this Security Agreement to the contrary, the grant of security interest in the Product Accounts shall not be effective or otherwise deemed given until the Effective Date, at which date the terms of this Security Agreement with respect to the Product Accounts shall become immediately effective without notice or action by Secured Party. Unless otherwise specified, all rights of Secured Party with respect to the Product Accounts contained herein shall be effective only on and after the Effective Date and until the Cure Date, and all obligations of Grantor with respect to the Product Accounts hereunder shall accrue only on and after the Effective Date and until the Cure Date. (d) Secured Party acknowledges and agrees that Grantor has granted, or shall grant, a first priority security interest in and Liens on the property of Grantor described in Schedule A hereto. 3. RETURN LICENSE. (a) Effective upon Secured Party taking any action to exercise any right or remedy under this Security Agreement with respect to the Collateral (whether by foreclosure, sale, or otherwise), Security Party hereby grants to Grantor an exclusive, worldwide, royalty-free license, with the right to sublicense, to practice the Licensed Patents for any and all purposes other than those activities which have been licensed to the Secured Party under Section 5.1.2 of the Collaboration Agreement (the "RETURN LICENSE"). (b) At all times prior to the effectiveness of the Return License, Grantor shall retain the unimpaired, worldwide, royalty-free right to practice, and to grant licenses to third parties to practice, the Licensed Patents for any and all purposes other than those activities which have been licensed exclusively to the Secured Party under Section 5.1.2 of the Collaboration Agreement, provided that such licenses shall be in accordance with Article 11 of the Collaboration Agreement. Proceeds realized by the Grantor from licenses permitted under this Section 3(b) shall be excluded from the definition of Collateral. 8 (c) Any transfer of any right, title or interest in or to any Licensed Patents by Secured Party to a third party (a "TRANSFEREE"), and any such transfer by a Transferee to any subsequent Transferee, shall at all times be subject to the Return License. If for any reason Secured Party exercises its rights and remedies under this Agreement in a manner that causes the right, title or interest in or to any Licensed Patents to transfer to a Transferee without the Secured Party first taking title to such Licensed Patents, the transfer of such right, title or interest in or to the Licensed Patents shall be conditioned upon, and at all times shall be subject to, the simultaneous grant by such Transferee (and any or all subsequent Transferees) of a Return License to Grantor. Secured Party shall not transfer, nor permit the transfer of, any right, title or interest in or to any Licensed Patents without the simultaneous grant by the Transferee to Grantor of a Return License, except to the extent otherwise permitted by the Collaboration Agreement. (d) The provisions of Article 11 of the Collaboration Agreement with respect to certain matters related to the prosecution, maintenance and enforcement of the Licensed Patents are hereby incorporated by reference into this Agreement to the extent that they are relevant to the Licensed Patents as described in such provisions. 4. REPRESENTATIONS AND WARRANTIES. Grantor hereby represents and warrants to Secured Party that: (a) Except for (i) the security interest granted to Secured Party under this Security Agreement and Permitted Liens, (ii) the co-ownership of certain Licensed Patents indicated in Schedule C by Grantor and the Regents of the University of Michigan, (iii) the license of certain Licensed Patents indicated in Schedule C by Grantor to the Regents of the University of Michigan, (iv) the license of certain Licensed Patents indicated in Schedule C by Grantor from the Regents of the University of Michigan, Grantor is the sole legal and equitable owner of each item of the Collateral in which it purports to grant a security interest hereunder, having good and marketable title thereto, free and clear of any and all Liens except for Permitted Liens. (b) No effective security agreement, financing statement, equivalent security or lien instrument or continuation statement covering all or any part of the Collateral exists, except such as may have been filed by Grantor in favor of Secured Party pursuant to this Security Agreement except for Permitted Liens. (c) This Security Agreement creates a legal and valid security interest on and in all of the Collateral in which Grantor now has rights and all filings and other actions necessary or desirable to perfect and protect such security interest have been duly taken, except to the extent necessary to perfect and protect such security interest in the Licensed Patents registered outside the United States. Accordingly, Secured Party has a fully perfected first priority security interest in all of the Collateral in which Grantor now has rights subject only to Permitted Liens, and except with respect to Licensed Patents registered outside the United States. This Security Agreement will create a legal and valid and first priority security interest in the Collateral in 9 which Grantor later acquires rights, when Grantor acquires those rights, subject only to Permitted Liens. (d) Grantor's chief executive office, principal place of business and the place where Grantor maintains its records concerning the Collateral are presently located at the address set forth on the signature page hereof. The Collateral is presently located at such address and at such additional addresses set forth on Schedule B attached hereto. 5. COVENANTS. Grantor covenants and agrees with Secured Party that from and after the date of this Security Agreement and until the Secured Obligations have been performed and paid in full: 5.1 DISPOSITION OF COLLATERAL. Grantor shall not sell, lease, transfer or otherwise dispose of any of the Collateral, or attempt or contract to do so, other than the disposal of worn-out or obsolete Equipment, all in the ordinary course of Grantor's business, or unless otherwise authorized to do so by the prior approval of Secured Party as evidenced in writing. 5.2 RELOCATION OF BUSINESS OR COLLATERAL. Grantor shall not relocate its chief executive office, principal place of business or its records, or allow the relocation of any Collateral (except as allowed pursuant to Section 4.1 immediately above) from such address(es) provided to Secured Party pursuant to Section 3(d) above without twenty (20) days prior written notice to Secured Party. 5.3 LIMITATION ON LIENS ON ASSETS. Grantor shall not create, incur, assume or permit to exist any Lien (including the charge upon Property at any time purchased or acquired under conditional sale or other title retention agreement) upon any asset now owned or hereafter acquired by it, other than Permitted Liens and Liens in favor of Secured Party. 5.4 INSURANCE. Maintain insurance policies insuring the Collateral against loss or damage from such risks and in such amounts and forms and with such companies as are customarily maintained by businesses similar to Grantor. 5.5 TAXES, ASSESSMENTS, ETC. Grantor shall pay promptly when due all property and other taxes, assessments and government charges or levies imposed upon, and all claims (including claims for labor, materials and supplies) against, the Equipment, Fixtures or Inventory, except to the extent the validity thereof is being contested in good faith and adequate reserves are being maintained in connection therewith. 5.6 MAINTENANCE OF RECORDS. Grantor shall keep and maintain at its own cost and expense satisfactory and complete records of the Collateral. 5.7 FURTHER ASSURANCES. Grantor shall execute and deliver financing and continuation statements for filing and recording under the UCC or other applicable law, landlord waivers, mortgagee waivers and other documents which Secured Party may request, in order to 10 perfect, preserve or enforce Secured Party's security interest in the Collateral or to enable Secured Party to exercise any of its rights hereunder, and shall pay all reasonable attorneys' fees and expenses in connection therewith. 6. Rights and Remedies Upon Default. (a) Beginning on the date any Event of Default (other than an Event of Default under Section 10(d) of the Loan Agreement, which shall be subject to the expiration of the cure period outlined in Section 13.3.1 of the Collaboration Agreement) shall have occurred and while such Event of Default is continuing, Secured Party may exercise in addition to all other rights and remedies granted to it under this Security Agreement, all rights and remedies of a secured party under the UCC; provided, however, that the exercise of any such remedies shall in all events be subject to and limited by the provisions of Section 3 relating to a Return License to Grantor. (b) Secured Party and Grantor understand and agree that money damages would not be a sufficient remedy for any breach of Article 3 of this Security Agreement by Secured Party, and that Grantor shall be entitled to specific performance and injunctive or other equitable relief as a remedy for any such breach. Such remedy shall not be deemed to be the exclusive remedy for breach of this Security Agreement, but shall be in addition to all other remedies available at law or equity to Grantor. No failure or delay by Grantor in exercising any right or remedy hereunder shall operate as a waiver thereof, and no single or partial exercise thereof shall preclude any other or further exercise thereof or the exercise of any other right or remedy hereunder. (c) Grantor also agrees to pay all fees, costs and expenses of Secured Party, including, without limitation, reasonable attorneys' fees, incurred in connection with the enforcement of any of its rights and remedies hereunder. (d) Grantor hereby waives presentment, demand, protest or any notice (to the maximum extent permitted by applicable law) of any kind in connection with this Security Agreement or any Collateral. (e) The Proceeds of any sale, disposition or other realization upon all or any part of the Collateral shall be distributed by Secured Party in the following order of priorities: FIRST, to Secured Party in an amount sufficient to pay in full the reasonable costs of Secured Party in connection with such sale, disposition or other realization, including all fees, costs, expenses, liabilities and advances incurred or made by Secured Party in connection therewith, including, without limitation, reasonable attorneys' fees; SECOND, to Secured Party in an amount equal to the then unpaid Secured Obligations; and 11 FINALLY, upon payment in full of the Secured Obligations, to Grantor or its representatives, in accordance with the UCC or as a court of competent jurisdiction may direct. 7. INDEMNITY. Grantor agrees to defend, indemnify and hold harmless Secured Party and its officers, employees, and agents against (a) all obligations, demands, claims and liabilities claimed or asserted by any other party in connection with the transactions contemplated by this Security Agreement and (b) all losses or expenses in any way suffered, incurred or paid by Secured Party as a result of or in any way arising out of, following or consequential to transactions between Secured Party and Grantor, whether under this Security Agreement or otherwise (including without limitation, reasonable attorneys fees and expenses), except for losses arising from or out of Secured Party's gross negligence or willful misconduct. 8. LIMITATION ON SECURED PARTY'S DUTY IN RESPECT OF COLLATERAL. Secured Party shall be deemed to have acted reasonably in the custody, preservation and disposition of any of the Collateral if it takes such action as Grantor requests in writing, but failure of Secured Party to comply with any such request shall not in itself be deemed a failure to act reasonably and no failure of Secured Party to do any act not so requested shall be deemed a failure to act reasonably. 9. REINSTATEMENT. This Security Agreement shall remain in full force and effect and continue to be effective should any petition be filed by or against Grantor for liquidation or reorganization, should Grantor become insolvent or make an assignment for the benefit of creditors or should a receiver or trustee be appointed for all or any significant part of Grantor's property and assets and shall continue to be effective or be reinstated, as the case may be, if at any time payment and performance of the Secured Obligations, or any part thereof, is, pursuant to applicable law, rescinded or reduced in amount or must otherwise be restored or returned by any obligee of the Secured Obligations, whether as a "voidable preference," "fraudulent conveyance" or otherwise, all as though such payment or performance had not been made. In the event that any payment, or any part thereof, is rescinded, reduced, restored or returned, the Secured Obligations shall be reinstated and deemed reduced only by such amount paid and not so rescinded, reduced, restored or returned. 10. MISCELLANEOUS. 10.1 NO WAIVER; CUMULATIVE REMEDIES. (a) Secured Party shall not by any act, delay, omission or otherwise be deemed to have waived any of its respective rights or remedies hereunder, nor shall any single or partial exercise of any right or remedy hereunder on any one occasion preclude the further exercise thereof or the exercise of any other right or remedy. (b) The rights and remedies hereunder provided are cumulative and may be exercised singly or concurrently and are not exclusive of any rights and remedies provided by law. 12 (c) None of the terms or provisions of this Security Agreement may be waived, altered, modified or amended except by an instrument in writing, duly executed by Grantor and Secured Party. 10.2 TERMINATION OF THIS SECURITY AGREEMENT. Subject to Section 9 hereof, this Security Agreement shall terminate upon the payment and performance in full of the Secured Obligations. 10.3 SUCCESSOR AND ASSIGNS. Neither party may assign or transfer this Security Agreement or any rights or obligations hereunder without the prior written consent of the other which shall not be unreasonably withheld, except a party may make such an assignment without the other party's consent to Affiliates or to a successor to substantially all of the pharmaceutical business of such party, whether in a merger, sale of stock, sale of assets or other transaction. Any permitted successor or assignee of rights and/or obligations hereunder shall, in a writing to the other party, expressly assume performance of such rights and/or obligations. Any permitted assignment shall be binding on the successors of the assigning party. Any assignment or attempted assignment by either party in violation of the terms of this Section 10 shall be null and void and of no legal effect. 10.4 GOVERNING LAW. In all respects, including all matters of construction, validity and performance, this Security Agreement and the Secured Obligations arising hereunder shall be governed by, and construed and enforced in accordance with, the laws of the State of Delaware applicable to contracts made and performed in such State, excluding conflict of laws principles that would cause the application of laws of any other jurisdiction, provided that the laws of the State of California shall be applied to the granting and perfection of the Secured Obligations arising hereunder. 13 In Witness Whereof, each of the parties hereto has caused this Security Agreement to be executed and delivered by its duly authorized officer on the date first set forth above. ADDRESS OF GRANTOR COULTER PHARMACEUTICAL, INC. 550 California Avenue, Suite 200 By: --------------------------------- Palo Alto, California 94306 Printed Name: ----------------------- U.S.A. Title: ------------------------------ ADDRESS OF SECURED PARTY SMITHKLINE BEECHAM CORPORATION One Franklin Plaza By: --------------------------------- Philadelphia, Pennsylvania 19101 Printed Name: ----------------------- U.S.A. Title: ------------------------------ 14 SCHEDULE A LIENS EXISTING OR ANTICIPATED ON THE DATE OF THIS SECURITY AGREEMENT 1. Liens to secure payment and performance of any and all Funded Indebtedness owing by Grantor to a Senior Lender in an aggregate principal amount not to exceed U.S. $10,000,000, which Liens shall include a first priority security interest in certain personal property of Grantor except the Licensed Patents and Know-How, and the Equipment of Grantor described in Section 2(a)(ii) hereof. 2. Liens to secure payment and performance of that Equipment Lease Financing Agreement dated as of December 6, 1996, between Grantor and Lease Management Services, Inc. 3. Letter of Credit pursuant to the Lease Agreement dated November 7, 1997, by and between HMS Gateway Office L.P. and Grantor. 4. Liens granted pursuant to the Facilities Agreement between MDS Nordion, Inc., and Grantor dated August 31, 1998. 1. 15 [USE IF COLLATERAL IS LOCATED AT PLACES OTHER THAN ADDRESS ON SIGNATURE PAGE.] SCHEDULE B LOCATION OF COLLATERAL ENTITY ADDRESS 1. 16 SCHEDULE C LICENSED PATENTS
ATTORNEY SERIAL NO. / FILED/ DOCKET NO. PATENT NO. ISSUED TITLE - ----------- ----------- ----------- ----------- [...***...] [...***...] [...***...] [...***...]
* Claims priority/effective filing date of earlier application ** ABANDONED in favor of Serial No. [...***...] OWNERSHIP INTERESTS: [...***...]: Co-owned by Grantor and the Regents of the University of Michigan. [...***...]: Owned by Grantor, with limited license back to MDS Nordion, Inc. [...***...]: Owned by the Regents of the University of Michigan, with license to Grantor. *CONFIDENTIAL TREATMENT REQUESTED 17 EXHIBIT A TO FINANCING STATEMENT BETWEEN SMITHKLINE BEECHAM CORPORATION, AS SECURED PARTY AND COULTER PHARMACEUTICAL, INC., AS DEBTOR - -------------------------------------------------------------------------------- This Financing Statement covers all right, title and interest of the Debtor in, to and under all of the following (collectively, the "COLLATERAL"): (a) The Licensed Patents and Know-How. The Licensed Patents in existence as of the date first written above are specifically listed on Schedule C. Schedule C shall be updated by the Grantor on a semi-annual basis; (b) All Equipment of Grantor located at, and relating to, Grantor's second radiolabeling site to be located in North America; provided if the second radiolabeling site is located at the Nordion Kanata, Canada radiolabeling site, then only such Equipment acquired in connection with the second radiolabeling site shall be within the scope of the term Equipment as used in this Section (b); (c) All Accounts of Debtor relating to the Licensed Compounds or Licensed Products pursuant to the Collaboration Agreement and not previously remitted to Debtor pursuant to Section 3.2.6, Section 3.3.3 and Section 7.1.14 of the Collaboration Agreement, as well as any other payments owed to Debtor by Secured Party under the Collaboration Agreement which have not been previously remitted to Debtor (the "PRODUCT ACCOUNTS"); and (d) To the extent not otherwise included, all Proceeds of each of the foregoing and all accessions to, substitutions and replacements for and rents, profits and products of each of the foregoing. The grant of the security interest in the Licensed Patents and Know-How shall be subject to the Return License granted by Secured Party to Grantor pursuant to Section 3 of the Security Agreement dated as of October 23, 1998, between Grantor and Secured Party (the "SECURITY AGREEMENT"). The grant of the security interest in the Product Accounts shall not be effective or otherwise deemed given until the Effective Date (as defined in the Security Agreement), at which date the terms of the Security Agreement with respect to the Product Accounts shall become immediately effective without notice or action by Secured Party. Unless otherwise specified, all rights of Secured Party with respect to the Product Accounts contained herein shall be effective only on and after the Effective Date and until the Cure Date (as defined in the Security Agreement), and all obligations of Grantor with respect to the Product Accounts shall accrue only on and after the Effective Date and until the Cure Date. 1. 18 Defined Terms. When used herein the following terms shall have the following meanings (such meanings being equally applicable to both the singular and plural forms of the terms defined): "004 TRIAL" means Grantor's clinical trial with Protocol No. RIT-II-004 ("Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy-Refractory Low-Grade B-Cell Lymphomas and Low-Grade Lymphomas That Have Transformed to Higher Grade Histologies") for which enrollment and interim analysis was completed prior to the date first written above. "ANTI-CD20 ANTIBODY" means: (i) the B1 Murine Antibody or any derivative of the B1 Murine Antibody, including without limitation, any genetically engineered construct of the B1 Murine Antibody; (ii) any other anti-CD20 monoclonal antibody other than the B1 Murine Antibody including, without limitation, human, humanized, primatized, or chimerized antibody; (iii) any [...***...] of (i) or (ii), (iv) any [...***...] of (i) or (ii); (v) any [...***...] of (i) or (ii); (vi) any [...***...] of (i) or (ii); (vii) any [...***...]. "BEXXAR" means B1 Murine Antibody conjugated with 131Iodine or unconjugated, depending upon context. "B1 MURINE ANTIBODY" means the unconjugated IgG2a anti-CD20 murine monoclonal antibody which is one of the active agents tested in the 004 Trial. "INVENTION" means an invention conceived or reduced to practice in the course of or as a result of the performance of the Collaboration Agreement by an employee or agent of Grantor. "KNOW-HOW" means all know-how, including development, manufacture development and commercialization data, processes and information, including any copyright relating thereto, owned or controlled by Grantor as of the date first written above or acquired during the term of this Security Agreement relating to: (e) Anti-CD20 Antibody, including any Licensed Compound or Licensed Product; (f) any component of (a); *CONFIDENTIAL TREATMENT REQUESTED 19 (g) any intermediate in the making of any of (a) or (b); (h) methods of making any of (a), (b) or (c); (i) any method of using any of (a), (b), or (c); (j) any use of (a); (k) any formulation or delivery system for (a); and/or (l) any other data related to the development, manufacture, marketing or sale of (a). "LICENSED COMPOUND" means Bexxar and any Second Generation Licensed Compounds. "LICENSED PATENTS" means all patents or patent applications, throughout the Territory and all divisionals, continuations, continuations-in-part, reissues, extensions, supplementary protection certificates thereof, owned or controlled by Grantor and existing as of the date first written above or filed or issuing during the term of this Security Agreement, at least one claim of which covers: (m) an Anti-CD20 Antibody, including any Licensed Compound or Licensed Product; (n) any component of (a); (o) any intermediate in the making of any of (a) or (b); (p) methods of making any of (a), (b) or (c); (q) any method of using any of (a), (b), or (c); (r) any use of (a); (s) any formulation or delivery system for (a); and/or (t) any other Invention related to the development, manufacture, use or sale of (a). "LICENSED PRODUCT" means any pharmaceutical product containing a Licensed Compound in any formulation or mode of administration. "SECOND GENERATION ANTIBODY CANDIDATE" means: (i) any derivative of the B1 Murine Antibody, including without limitation, any genetically engineered construct of the B1 Murine Antibody; 20 (ii) any other anti-CD20 monoclonal antibody other than the B1 Murine Antibody including, without limitation, human, humanized, primatized, or chimerized antibody, (iii) any [...***...] of (i) or (ii), (iv) any [...***...] of (i) or (ii), (v) any [...***...] of (i) or (ii), (vi) any [...***...] of (i) or (ii), (vii) any [...***...] of (i) or (ii), or (viii) any [...***...]. "SECOND GENERATION LICENSED COMPOUND" means a Second Generation Licensed Compound Candidate (i) for which an SB Option Exercise Notice has been provided pursuant to Section 4.2.2(a) of the Collaboration Agreement or (ii) which has become a Second Generation Licensed Compound in accordance with Section 4.2.4(a)-(b) of the Collaboration Agreement. "SECOND GENERATION LICENSED COMPOUND CANDIDATE" shall mean (i) an unconjugated Second Generation Antibody Candidate; (ii) B1 Murine Antibody conjugated to [...***...]; (iii) a Second Generation Antibody Candidate conjugated to [...***...]; or (iv) a Second Generation Antibody Candidate conjugated to [...***...]. "TERRITORY" means all countries and territories of the world except for Japan. "UCC" means the Uniform Commercial Code as the same may, from time to time, be in effect in the State of California; provided, however, in the event that, by reason of mandatory provisions of law, any or all of the attachment, perfection or priority of Secured Party's security interest in any Collateral is governed by the Uniform Commercial Code as in effect in a jurisdiction other than the State of California, the term "UCC" shall mean the Uniform Commercial Code as in effect in such other jurisdiction for purposes of the provisions hereof relating to such attachment, perfection of priority and for purposes of definitions related to such provisions. In addition, the following terms shall be defined terms having the meaning set forth for such terms in the UCC (definition sections of the UCC are noted parenthetically): "Accounts" (9106); "Equipment" (9109(2)); "Proceeds" (9306(1)). Each of the foregoing defined terms shall include all of such items now owned, or hereafter acquired, by Debtor. *CONFIDENTIAL TREATMENT REQUESTED 21 SCHEDULE C TO EXHIBIT A LICENSED PATENTS
ATTORNEY SERIAL NO. / FILED/ DOCKET NO. PATENT NO. ISSUED TITLE - ----------- ----------- ----------- ----------- [...***...] [...***...] [...***...] [...***...]
* Claims priority/effective filing date of earlier application ** ABANDONED in favor of Serial No. [...***...] OWNERSHIP INTERESTS: [...***...]: Co-owned by Grantor and the Regents of the University of Michigan. [...***...]: Owned by Grantor, with limited license back to MDS Nordion, Inc. [...***...]: Owned by the Regents of the University of Michigan, with license to Grantor. *CONFIDENTIAL TREATMENT REQUESTED 1.
EX-10.23 4 GRANT OF SECURITY INTEREST W/ SMITHKLINE BEECHAM 1 EXHIBIT 10.23 *** Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4), 200.83 and 240.24b-2 GRANT OF SECURITY INTEREST (PATENTS AND PATENT APPLICATIONS) THIS GRANT OF SECURITY INTEREST (PATENTS AND PATENT APPLICATIONS) is dated as of October 23, 1998, between COULTER PHARMACEUTICAL, INC., a corporation formed under the laws of the State of Delaware, having its principal place of business at 550 California Avenue, Suite 200, Palo Alto, California 94306, USA (the "Assignor"), and SMITHKLINE BEECHAM CORPORATION, with its principal place of business at One Franklin Plaza, Philadelphia, Pennsylvania 19101, USA ( the "Assignee"). WHEREAS, pursuant to a certain Loan Agreement dated as of even date herewith (as the same may be amended, modified, supplemented or restated from time to time, the "Loan Agreement"), by and between the Assignor and the Assignee, the Assignee has agreed to make certain advances of money and to extend certain financial accommodations to Assignee in the amounts and manner set forth in the Loan Agreement (collectively, the "Loans"). WHEREAS, pursuant to the terms of a certain Security Agreement dated as of even date herewith (as the same may be amended, modified, supplemented or restated, the "Security Agreement"), made by the Assignor in favor of the Assignee, the Assignor has granted to the Assignee a security interest in all of the Assignor's right, title and interest, whether presently existing or hereafter arising or acquired, in, to and under all of the Assignor's "Collateral," as defined in the Security Agreement. WHEREAS, the Assignee is willing to make the Loans to the Assignor, but only upon the condition, among others, that the Assignor shall grant a security interest and assign for security purposes (and not as an absolute assignment) in favor of and to the Assignee, all of its right, title and interest in and to all Licensed Patents (as defined in the Security Agreement) to secure the Obligations of the Assignee under the Loan Agreement and the other Loan Documents. NOW, THEREFORE, for good and valuable consideration, receipt of which is hereby acknowledged, as collateral security for the prompt and complete payment when due of its Obligations under the Loan Agreement, the Note and the other Loan Documents, the Assignor hereby represents, warrants, covenants and agrees as follows: 1. Unless otherwise defined herein, the terms defined in the Loan Agreement are used herein as therein defined. 2. To secure its Obligations, the Assignor does hereby mortgage and pledge to the Assignee, and grant to the Assignee a security interest in, all of the Assignor's right, title and interest in, to and under its Licensed Patents, including, without limitation the patents and patent 1. 2 applications listed on Schedule A attached hereto, including, without limitation, all proceeds thereof. The Assignee does hereby further acknowledge and affirm that the rights and remedies of the Assignor with respect to the assignment of and security interest in the Collateral made and granted hereby are more fully set forth in the Security Agreement, the terms and provisions of which are hereby incorporated herein by reference. Following the termination of the Security Agreement in accordance with its terms, the Licensed Patents, Know-How and any and all financing statements filed on behalf of the Assignee will be automatically reassigned to the Assignor, and the Assignee will execute such instruments as may be reasonably requested to evidence such reassignment. 2. 3 In Witness Whereof, each of the parties have caused this Grant of Security Interest (Patents and Patent Applications) to be duly executed by its officers thereunto duly authorized as of the date first written above. ASSIGNOR: COULTER PHARMACEUTICAL, INC., By: --------------------------------- Printed Name: ----------------------- Title: ------------------------------ ASSIGNEE: SMITHKLINE BEECHAM CORPORATION By: --------------------------------- Printed Name: ----------------------- Title: ------------------------------ 3. 4 SCHEDULE A LICENSED PATENTS
ATTORNEY SERIAL NO. / FILED/ DOCKET NO. PATENT NO. ISSUED TITLE - ----------- ----------- ----------- ----------- [...***...] [...***...] [...***...] [...***...]
* Claims priority/effective filing date of earlier application ** ABANDONED in favor of Serial No. [...***...] OWNERSHIP INTERESTS: [...***...] Co-owned by Grantor and the Regents of the University of Michigan. [...***...] Owned by Grantor, with limited license back to MDS Nordion, Inc. [...***...] Owned by the Regents of the University of Michigan, with license to Grantor. *CONFIDENTIAL TREATMENT REQUESTED SCHEDULE A PAGE 1 OF 1
EX-10.24 5 LOAN AGREEMENT W/ SMITHKLINE BEECHAM 1 Exhibit 10.24 *** Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4), 200.83 and 240.24b-2 LOAN AGREEMENT THIS LOAN AGREEMENT is entered into as of October 23, 1998 (this "Loan Agreement"), between COULTER PHARMACEUTICAL, INC., a corporation formed under the laws of the State of Delaware, with its principal place of business at 550 California Avenue, Suite 200, Palo Alto, California 94306, USA ("Borrower"), and SMITHKLINE BEECHAM CORPORATION, a corporation formed under the laws of the Commonwealth of Pennsylvania, with its principal place of business at One Franklin Plaza, Philadelphia, Pennsylvania 19101, USA ("Lender"). This Loan Agreement shall not be effective until the Effective Date. 1. DEFINITIONS. As used in this Loan Agreement and unless otherwise defined herein, all initially capitalized terms shall have the meanings set forth on EXHIBIT A attached hereto and incorporated herein by this reference. 2. COMMITMENT. Subject to all the terms and conditions of this Loan Agreement and prior to the termination of its commitment as hereinafter provided, Lender hereby agrees to make loans (each a "Loan" and collectively "Loans") to Borrower, from time to time and in such amounts as Borrower shall request pursuant to SECTION 2(a) hereof up to, but not exceeding, an aggregate unpaid principal balance of U.S. $15,000,000 (the "Commitment"). If at any time or for any reason, the outstanding principal amount of the Loans is greater than the Commitment, Borrower shall immediately pay to Lender the amount of such excess. The Commitment of Lender, pursuant to the terms of this Loan Agreement, to make Loans shall expire on the date that is twenty-four (24) months after the Effective Date (the "Expiration Date"). Borrower promises to pay to Lender the entire outstanding unpaid principal balance (and all accrued unpaid interest thereon) of the Loans no later than the date that is sixty (60) months after the Effective Date ("Maturity Date"). (a) LOANS. At any time from the Effective Date and prior to the Expiration Date, Borrower may from time to time request Loans from Lender for the purpose of clinical development, process development, manufacture, and sales and marketing of Bexxar, in accordance with the Collaboration Agreement. (b) PRINCIPAL PAYMENTS. (i) In the event that Borrower's EBITDA for the twelve (12) month period ending September 30, 2001 exceeds U.S. $[...***...] then on the date that is thirty-six (36) months after the Effective Date, Borrower shall make a principal payment of an amount equal to [***] percent ([...***...]%) of then outstanding principal balance of the Loans; (ii) in the event that Borrower's EBITDA for the twelve (12) month period ending September 30, 2002 exceeds U.S. $[...***...], then on the date that is forty-eight (48) months after the Effective Date, Borrower shall make a principal payment of an amount equal to [...***...] *Confidential Treatment Requested 1. 2 percent ([...***...]%) of then outstanding principal balance of the Loans; and (iii) Borrower shall repay the entire outstanding unpaid principal balance of the Loans, together with all accrued unpaid interest thereon, on the Maturity Date. At the Borrower's option under this SECTION 2(B), principal payments, together with all accrued unpaid interest thereon, may be paid in cash or the amount of Borrower's Common Stock ("Shares") equal to the quotient of the amount repaid divided by the Share Price (as hereinafter defined). The "Share Price" shall be the closing price of Borrower's Common Stock on the Nasdaq National Market, as reported by the Wall Street Journal, Western Edition (the "Wall Street Journal"), on the last trading day preceding the payment date. In the event the number of Shares so calculated would include a fraction of a Share, the number of Shares shall be decreased to the nearest whole number of Shares and the balance of the amount to be repaid shall be paid in cash. Any Shares delivered pursuant to this SECTION 2(b) shall be issued pursuant to an effective registration statement under the Securities Act of 1933, as amended, and shall be freely tradable. (c) PREPAYMENTS. Borrower may prepay the Loans in cash, or Shares equal to the quotient of the amount repaid divided by the Share Price, at any time (including, without limitation, upon the occurrence of an Event of Default) in full, or in part, in minimum amounts of U.S. $100,000. In the event the number of Shares so calculated would include a fraction of a Share, the number of Shares shall be decreased to the nearest whole number of Shares and the balance of the amount to be repaid shall be paid in cash. Any Shares delivered pursuant to this SECTION 2(c) shall be issued pursuant to an effective registration statement under the Securities Act of 1933, as amended, and shall be freely tradable. 3. PAYMENT OF INTEREST ON ALL LOANS. (a) INTEREST RATES. Each Loan shall bear interest on the outstanding principal amount thereof from the date when made until paid in full at a fixed rate per annum equal to the Prime Rate in effect on the date such Loan is advanced, or the maximum permissible rate by law (which under the laws of the State of Delaware shall be deemed to be the laws relating to the permissible rate of interest on commercial loans), whichever is less. (b) INTEREST PAYMENT DATES. Interest on each Loan shall be paid in cash in arrears on the last day of each March, June, September and December. Interest shall also be paid in cash on the date of any prepayment of any Loans pursuant to SECTION 2(c) of this Loan Agreement for the portion of the Loans so prepaid and upon payment (including prepayment) in full thereof. (c) CALCULATION OF INTEREST. Interest on the Loans shall be computed on the basis of a 365/366-day year and the actual number of days elapsed. 4. CONDITIONS TO ADVANCE OF LOANS. The Borrower shall initiate an advance under this Loan Agreement by written request to the Lender delivered not less than three Business Days prior to the date of the requested advance. The obligation of Lender to consummate the loan transaction contemplated under this Loan Agreement and the other Loan Documents, and to advance each Loan hereunder is subject to the satisfaction of the following conditions precedent: *Confidential Treatment Requested 2. 3 (a) Lender shall have received this Loan Agreement and all of the other Loan Documents duly executed and delivered by Borrower. (b) There shall not exist a condition which would constitute an Event of Default. (c) There shall not exist a breach of any of the financial covenants set forth in SECTION 8 hereof. (d) All representations and warranties shall be and continue to be true and correct. (e) Borrower shall have cash and marketable securities available for sale in an aggregate amount not less than [...***...], net of the amount of any Loans made during the immediately preceding ninety (90) day period. (f) The aggregate principal amount of Loans which would be outstanding following any requested advance shall not exceed the Borrower's share of the expenses approved by the JDC and/or the JCC in accordance with the provisions of the Collaboration Agreement. (g) Borrower shall deliver a certificate in the form of Exhibit C hereto signed by the Chief Financial Officer of the Borrower certifying compliance by the Borrower with each of the conditions precedent set forth in SECTIONS 4(A) through 4(E) as of the date of the requested advance. (h) Borrower shall have established the Cash Collateral Account. 5. REPRESENTATIONS AND WARRANTIES. Borrower represents and warrants to Lender: (a) Borrower is a corporation, duly organized, validly existing and in good standing under the laws of the State of Delaware, U.S.A., and the execution, delivery and performance of each of the Loan Documents to which it is a party are within Borrower's powers, have been duly authorized and are not in conflict with law or the terms of any articles of incorporation, bylaws or other charter documents, or of any indenture, agreement or undertaking to which Borrower is a party or by which Borrower is bound or affected; (b) this Loan Agreement and the other Loan Documents to which it is a party constitute legal, valid and binding obligations of Borrower enforceable against Borrower in accordance with their respective terms; (c) except for Permitted Liens, Borrower owns and has good title to or has valid leases or licenses for the use of all of its Property free and clear of all Liens, and has not executed any security documents or financing statements relating to such Property; (d) there is no material litigation or other proceeding pending or threatened against or affecting Borrower, and Borrower is not in default with respect to any order, writ, injunction, decree or demand of any court or other governmental or regulatory authority; (e) as of the date first written above the Borrower has no Subsidiaries other than Coulter Pharma Belgium; (f) there exists no condition which constitutes an Event of Default; and (g) there has been no material adverse change in the financial condition, results or operations or * CONFIDENTIAL TREATMENT REQUESTED 3. 4 prospects of the Borrower since the date of the Borrower's annual report on Form 10-K for the year ending December 31, 1997. 6. AFFIRMATIVE COVENANTS. Borrower affirmatively covenants and agrees that so long as any Obligations shall be outstanding or the Commitment shall be available, it will: (a) Promptly notify Lender in writing of any attachment or other legal process levied against any of the Collateral and any information received by Borrower relative to the Collateral which may in any way affect the value of the Collateral or the rights and remedies of Lender in respect thereto; (b) Maintain and preserve all rights, franchises and other authority adequate and necessary for the conduct of its business and maintain and preserve its existence in the State of its organization and any other state(s) in which Borrower conducts its business, except with respect to such other state(s) in which the failure to do so would not have a material adverse effect on the business or financial condition of Borrower; (c) Maintain public liability, property damage and workers compensation insurance and insurance on all its insurable property against fire and other hazards with responsible insurance carriers to the extent usually maintained by similar businesses; (d) Maintain its properties, equipment and facilities in good order and repair; (e) Use all Loan proceeds solely for the purpose of clinical development, process development, manufacture, and sales and marketing of Bexxar, in accordance with the Collaboration Agreement; and (f) Cause each domestic Subsidiary of Borrower hereafter formed or acquired to execute and deliver a Guaranty to Lender, such Guaranty to be in the form attached hereto as Exhibit D. 7. NEGATIVE COVENANTS. Borrower covenants and agrees that so long as any Obligations shall be outstanding or the Commitment shall be available, Borrower will not, without the prior written consent of Lender: (a) Create, incur, assume or permit to exist any Lien (including the charge upon Property at any time purchased or acquired under conditional sale or other title retention agreement) upon any asset now owned or hereafter acquired by it, other than Permitted Liens and Liens in favor of Lender; (b) Sell, dispose of or grant a security interest in any of the Collateral other than to Lender (other than the disposing of tangible assets which are obsolete or otherwise considered surplus), or execute any financing statements covering the Collateral in favor of any Person other than Lender or the beneficiary of a Permitted Lien; and 4. 5 (c) Borrow an aggregate principal amount of Loans during any twelve (12) month period in excess of Borrower's share of the expenses for that period approved by the JDC and/or the JCC in accordance with the provisions of the Collaboration Agreement. 8. FINANCIAL COVENANTS. Borrower covenants and agrees that so long as any Obligations shall be outstanding or any Commitment shall be available, Borrower shall maintain all of the following financial covenants; provided, however, that in no event shall [...***...] the following financial covenants [...***...]: (a) MINIMUM REMAINING MONTHS LIQUIDITY. Until such time as Borrower maintains a Debt Service Coverage Ratio of not less than [...***...] for two (2) consecutive Fiscal Quarters, maintain as at the end of each Fiscal Quarter, a Remaining Months Liquidity of not less than six (6) months. (b) MINIMUM DEBT SERVICE COVERAGE RATIO. Maintain as at the end of each Fiscal Quarter, a Debt Service Coverage Ratio of not less than [...***...]; provided, however, that Borrower shall be deemed to satisfy this covenant so long as Borrower maintains Remaining Months Liquidity of not less than six (6) months. (c) MINIMUM CONSOLIDATED TANGIBLE NET WORTH. Maintain as at the end of each Fiscal Quarter, Consolidated Tangible Net Worth of an amount not less than [...***...]. (d) MAXIMUM CONSOLIDATED LEVERAGE RATIO. Maintain as at the end of each Fiscal Quarter, a Consolidated Leverage Ratio of not greater than [...***...]. In the event that Borrower fails to maintain any of the foregoing financial covenants, then no later than three Business Days after the date that Borrower becomes aware of any such failure, Borrower shall deposit into the Cash Collateral Account (as defined below) an amount of cash (the "Cash Collateral") not less than the then-outstanding principal amount of the Loans, grant to Lender a first priority perfected security interest in the Cash Collateral Account, and provide to Lender any documentation required to evidence and perfect such security interest under applicable law. The "Cash Collateral Account" shall be a deposit account of any domestic commercial bank (or the parent company of such bank) whose short-term commercial paper rating from Standard & Poor's Rating Group is at least A-1 or the equivalent thereof or from Moody's Investors Service, Inc. is at least P-1 or the equivalent thereof; provided that the Cash Collateral Account shall be "blocked" such that Lender shall have control, as defined under the Uniform Commercial Code of the applicable jurisdiction, of the Cash Collateral Account at any time Borrower has failed to maintain a financial covenant set forth in SECTION 8 hereof and until such time as Borrower has cured such failure to maintain such financial covenants. Notwithstanding anything to the contrary herein, so long as Borrower has satisfied any contractual obligation to any Senior Lender to provide cash collateral to secure such Senior Lender's Funded Indebtedness upon the failure of Borrower to maintain financial covenants for the benefit of such Senior Lender (and such Senior Lender has not waived such requirement prior to the date upon which Borrower cures its failure to maintain such financial covenants), then the *CONFIDENTIAL TREATMENT REQUESTED 5. 6 principal amount of the required Cash Collateral shall be reduced by the value of Product Accounts (as defined in the Security Agreement); provided, that if Senior Lender thereafter waives Borrower's cash collateral requirement to such Senior Lender, no later than three Business Days thereafter Borrower shall deposit into the Cash Collateral Account cash in a principal amount not less than the difference between the then-outstanding principal amount of the Loans and any then-existing Cash Collateral; provided further, on the date upon which Borrower cures its failure to maintain any of the financial covenants set forth in this SECTION 8, Lender shall release its security interest in all of such Cash Collateral, and shall notify the bank maintaining the Cash Collateral Account that the triggering event has been cured and that Lender rescinds its control of the Cash Collateral Account. 9. FINANCIAL INFORMATION. Borrower covenants and agrees that so long as any Obligations shall be outstanding or the Commitment shall be available, Borrower shall provide the following financial information to Lender: (a) QUARTERLY FINANCIAL STATEMENTS. As soon as practicable and in any event within forty-five (45) days after and as of the end of each Fiscal Quarter, internally-prepared consolidated balance sheets, statements of income and cash flow of Borrower as at the end of such period, all in reasonable detail and certified by the chief financial officer of Borrower that they (i) are complete and fairly present the financial condition of Borrower as at the dates indicated and the results of its operations and changes in its cash flow for the periods indicated, (ii) disclose all liabilities that are required to be reflected or reserved against under GAAP, whether liquidated or unliquidated, fixed or contingent, and (iii) have been prepared in accordance with GAAP, subject to changes resulting from audit and normal year-end adjustment, together with a Compliance Certificate in the form of Exhibit B to this Loan Agreement duly completed and certified by the chief financial officer of Borrower. (b) ANNUAL AUDITED FINANCIAL STATEMENTS. As soon as practicable and in any event within ninety (90) days after the end of each Fiscal Year, consolidated balance sheets, statements of income and cash flow of Borrower as at the end of such Fiscal Year, all in reasonable detail and accompanied by a report thereon of independent public accountants of recognized national standing selected by Borrower and reasonably satisfactory to Lender, which report shall be unqualified and shall not contain an adverse opinion, or a disclaimer of opinion, shall not express doubts about the ability of Borrower to continue as a going concern, or be qualified or limited because of a restricted or limited examination by such accountant of any material portion of Borrower's records and shall state that such consolidated financial statements present fairly the financial position of Borrower as at the dates indicated and the results of operations and changes in financial position for the periods indicated in conformity with GAAP applied on a basis consistent with prior years (except as otherwise stated therein) and that the examination by which such auditors in connection with such consolidated and consolidating financial statements has been made in accordance with generally accepted auditing standards, together with a Compliance Certificate in the form of Exhibit B to this Loan Agreement duly completed and certified by the chief financial officer of Borrower. 6. 7 10. EVENT OF DEFAULT. The occurrence of any one or more of the following shall constitute an "Event of Default": (a) default be made in the payment of any Obligation by Borrower under any Loan Document and such default shall not have been cured within five (5) days after Borrower's receipt of written notice from Lender; (b) except for any failure to pay as described in clause (a) above, or any [.....***.....] in [.....***.....], above, breach be made in any representation, warranty, statement, covenant, promise, term or condition contained herein or in any other Loan Document and the same shall not have been cured within thirty (30) days after Borrower's receipt of written notice from Lender; (c) any statement, warranty or representation made by Borrower at any time proves to have been false in any material aspect at the time made; (d) there shall exist an uncured default or event of default by Borrower in the performance of any obligation to SmithKline Beecham Corporation (or its successors or assigns) under the Collaboration Agreement or otherwise; (e) the Collaboration Agreement is terminated in accordance with the provisions thereof for any reason other than a material breach by Lender; (f) Borrower defaults in the repayment of any principal of or the payment of any interest on any Funded Indebtedness or breaches or violates any term or provision of any promissory note, loan agreement, mortgage, indenture or other evidence of such Funded Indebtedness, if the effect of such breach is the acceleration of such Funded Indebtedness; (g) Borrower becomes insolvent or makes an assignment for the benefit of creditors; (h) any proceeding be commenced by Borrower under the Bankruptcy Code or any reorganization, arrangement, readjustment of debt or moratorium law or statute, or any such proceeding is commenced against Borrower and is not dismissed or stayed within sixty (60) days; or (i) any failure to provide the Cash Collateral to the Lender as set forth in SECTION 8, above. 11. REMEDIES. Upon the occurrence and during the continuance of an Event of Default, Lender may, at its option and without demand first made and without notice to Borrower, do any one or more of the following: (a) terminate its obligation to make Loans to Borrower as provided in SECTION 2 hereof; (b) declare all sums secured hereby immediately due and payable; or (c) exercise any remedies pursuant to the Security Agreement or any remedies of a secured party under the Uniform Commercial Code. Lender shall have the right to enforce one or more remedies hereunder successively or concurrently, and any such action shall not estop or prevent Lender from pursuing any further remedy that it may have hereunder or by law. 12. MISCELLANEOUS PROVISIONS. (a) ENTIRE AGREEMENT. This Loan Agreement and each of the other Loan Documents to which it is a party, taken together, constitute and contain the entire agreement among Borrower and Lender and supersede any and all prior agreements, negotiations, correspondence, understandings and communications among the parties, whether written or oral, respecting the subject matter hereof. (b) NO WAIVER. No failure or delay on the part of Lender in the exercise of any power, right or privilege under this Loan Agreement or any of the other Loan Documents shall impair such power, right or privilege or be construed to be a waiver of any default or *Confidential Treatment Requested 7. 8 acquiescence therein, nor shall any single or partial exercise of any such power, right or privilege preclude other or further exercise thereof or of any other right, power or privilege. (c) RELIANCE BY LENDER. All covenants, agreements, representations and warranties made herein by Borrower shall, notwithstanding any investigation by Lender be deemed to be material to and to have been relied upon by Lender. (d) HEADINGS. Section and subsection headings in this Loan Agreement are included herein for convenience of reference only and shall not constitute a part of this Loan Agreement for any other purpose or be given any substantive effect. (e) SEVERABILITY. Whenever possible, each provision of this Loan Agreement and each of the other Loan Documents shall be interpreted in such a manner as to be valid, legal and enforceable under the applicable law of any jurisdiction. Without limiting the generality of the foregoing sentence, in case any provision of this Loan Agreement or any of the other Loan Documents shall be invalid, illegal or unenforceable under the applicable law of any jurisdiction, the validity, legality and enforceability of the remaining provisions, or of such provision in any other jurisdiction, shall not in any way be affected or impaired thereby. (f) GOVERNING LAW. Except as otherwise expressly provided in any of the Loan Documents, in all respects, including all matters of construction, validity and performance, this Loan Agreement and the Obligations arising hereunder shall be governed by, and construed and enforced in accordance with, the laws of the State of Delaware applicable to contracts made and performed in such state, without regard to the principles thereof regarding conflict of laws, and any applicable laws of the United States of America. (g) SUCCESSORS AND ASSIGNS. Neither party may assign or transfer this Loan Agreement or any rights or obligations hereunder without the prior written consent of the other which shall not be unreasonably withheld, except a party may make such an assignment without the other party's consent to an Affiliate or to a successor to substantially all of the pharmaceutical business of such party, whether in a merger, sale of stock, sale of assets or other transaction. Any permitted successor or assignee of rights and/or obligations hereunder shall, in a writing to the other party, expressly assume performance of such rights and/or obligations. Any permitted assignment shall be binding on the successors of the assigning party. Any assignment or attempted assignment by either party in violation of the terms of this SECTION 12(g) shall be null and void and of no legal effect. COUNTERPARTS. This Loan Agreement may be executed in any number of counterparts, each of which when so delivered shall be deemed an original, but all such counterparts shall constitute but one and the same instrument. Each such agreement shall become effective upon the execution of a counterpart hereof or thereof by each of the parties hereto and telephonic notification that such executed counterparts has been received by Borrower and Lender. 8. 9 BORROWER: LENDER: COULTER PHARMACEUTICAL, INC. SMITHKLINE BEECHAM CORPORATION By: By: --------------------------------- --------------------------------- Printed Name: Printed Name: ----------------------- ----------------------- Title: Title: ------------------------------ ------------------------------ 9. 10 LIST OF EXHIBITS AND SCHEDULES EXHIBIT A: Definitions SCHEDULE 1 TO EXHIBIT A: List of Specific Permitted Indebtedness SCHEDULE 2 TO EXHIBIT A: List of Specific Permitted Liens EXHIBIT B: Form of Compliance Certificate re Financial Covenants EXHIBIT C: Form of Compliance Certificate re Conditions Precedent to Loans EXHIBIT D: Form of Guaranty to Be Executed by Borrower's Domestic Subsidiaries 10. 11 EXHIBIT A DEFINITIONS "004 TRIAL" means Borrower's clinical trial with Protocol No. RIT-II-004 ("Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy-Refractory Low-Grade B-Cell Lymphomas and Low-Grade Lymphomas That Have Transformed to Higher Grade Histologies") for which enrollment and interim analysis was completed prior to the Effective Date. "AFFILIATE" means, in the case of either Borrower or Lender, any corporation, joint venture or other business entity which directly or indirectly controls, is controlled by, or is under common control with that party. "CONTROL," as used in this definition, shall mean having the power to direct, or cause the direction of, the management and policies of an entity, whether through ownership of voting securities, by contract or otherwise. "BANKRUPTCY CODE" means the Bankruptcy Code of 1978, as amended, as codified under Title 11 of the United States Code, and the Bankruptcy Rules promulgated thereunder, as the same may be in effect from time to time. "BEXXAR" means B1 Murine Antibody conjugated with 131Iodine or unconjugated, depending upon context. "B1 MURINE ANTIBODY" means the unconjugated IgG2a anti-CD20 murine monoclonal antibody which is one of the active agents tested in the 004 Trial. "BUSINESS DAY" means any day which is not a Saturday, Sunday or a legal holiday under the laws of the State of California or is not a day on which banking institutions located in the State of California are authorized or required by law or other governmental action to close. "CAPITAL LEASE" means, as to any Person, any lease of any Property by such Person as lessee that is, or should be in accordance with Financing Accounting Standards Board Statement No. 13, classified and accounted for as a "capital lease" on the balance sheet of such Person prepared in accordance with GAAP. "CAPITAL LEASE OBLIGATION" means, with respect to any Capital Lease, the amount of the obligation of the lessee thereunder that, in accordance with GAAP, would appear on a balance sheet of such lessee in respect of such Capital Lease or otherwise be disclosed in a note to such balance sheet. "CASH COLLATERAL" shall have the meaning set forth in SECTION 8. "CASH COLLATERAL ACCOUNT" shall have the meaning set forth in SECTION 8. 1. 12 "Collaboration Agreement" means that certain Collaboration Agreement entered into as of the same day as this Loan Agreement, between Coulter Pharmaceutical, Inc. and SmithKline Beecham Corporation relating to Bexxar. "COLLATERAL" means any and all personal property of Borrower which is assigned or hereafter is assigned to Lender as security or in which Lender now has or hereafter acquires a security interest pursuant to the terms of the Security Agreement or otherwise. "COMMITMENT" has the meaning set forth in SECTION 2. "CONSOLIDATED LEVERAGE RATIO" means the ratio of (a) Consolidated Total Liabilities to (b) Consolidated Tangible Net Worth. "CONSOLIDATED TANGIBLE ASSETS" means, on a consolidated basis, as at any date of determination, the difference between Consolidated Total Assets and all intangible assets of Borrower, as determined and computed in accordance with GAAP. "CONSOLIDATED TANGIBLE NET WORTH" means on a consolidated basis, as at any date of determination, the difference between Consolidated Tangible Assets and Consolidated Total Liabilities. "CONSOLIDATED TOTAL ASSETS" means on a consolidated basis, as at any date of determination, all assets of Borrower, as determined and computed in accordance with GAAP. "CONSOLIDATED TOTAL LIABILITIES" means on a consolidated basis, as at any date of determination, all liabilities of Borrower, determined and computed in accordance with GAAP. "CONTINGENT OBLIGATION" means, as applied to any Person, any direct or indirect liability, contingent or otherwise, of that Person with respect to any indebtedness, lease, dividend, letter of credit or other obligation of another, including, without limitation, any such obligation directly or indirectly guaranteed, endorsed (otherwise than for collection or deposit in the ordinary course of business), co-made or discounted or sold with recourse by that Person, or in respect of which that Person is otherwise directly or indirectly liable, including, without limitation, any such obligation for which that Person is in effect liable through any agreement (contingent or otherwise) to purchase, repurchase or otherwise acquire such obligation or any security therefor, or to provide funds for the payment or discharge of such obligation (whether in the form of loans, advances, capital stock purchases, capital contributions or otherwise), or to maintain the solvency of the obligor of such obligation, or to make payment for any products, materials or supplies or for any transportation, services or lease regardless of the non-delivery or non-furnishing thereof, in any such case if the purpose or intent of such agreement is to provide assurance that such obligation will be paid or discharged, or that any agreements relating thereto will be complied with, or that the holders of such obligation will be protected (in whole or in part) against loss in respect thereof. The amount of any Contingent Obligation of any Person shall be deemed to be an amount equal to the maximum amount of such Person's liability with respect to the stated or determinable amount of the primary obligation for which such Contingent 2. 13 Obligation is incurred or, if not stated or determinable, the maximum reasonably anticipated liability in respect thereof (assuming such Person is required to perform thereunder). "DEBT SERVICE COVERAGE RATIO" means the ratio of (a) net profit plus depreciation, amortization and other non-cash charges to (b) the current portion of long term debt. "EBITDA" means, as at any date of determination, for any period, an amount equal to the sum of (i) net income (without giving effect to any extraordinary non-cash gains or extraordinary non-cash losses), plus (ii) interest expense, plus (iii) provisions for income taxes, plus (iv) depreciation, plus (v) amortization, each as determined and calculated in accordance with GAAP "EFFECTIVE DATE" has the meaning set forth in the Collaboration Agreement. "EXPIRATION DATE" has the meaning set forth in SECTION 2. "EVENT OF DEFAULT" has the meaning set forth in SECTION 10. "FISCAL QUARTER" means each fiscal quarter of Borrower ending on each March 31, June 30, September 30 and December 31. "FISCAL YEAR" means each fiscal year of Borrower ending on December 31. "FUNDED INDEBTEDNESS" means, as to any Person, without duplication, (a) all indebtedness of such Person for borrowed money, including, without limitation, all of such indebtedness outstanding under this Loan Agreement and any of the other Loan Documents; (b) all Capital Lease Obligations of such Person; (c) to the extent of the outstanding indebtedness thereunder, any obligation of such Person representing an extension of credit to such Person, whether or not for borrowed money; (d) any obligation of such Person for the deferred purchase price of Property or services (other than (i) trade or other accounts payable in the ordinary course of business in accordance with customary industry terms and (ii) deferred franchise fees); (e) all Contingent Obligations; (f) any obligation of such Person of the nature described in clauses (a), (b), (c), (d) or (e) above, that is secured by a Lien on assets of such Person and which is non-recourse to the credit of such Person, but only to the extent of the fair market value of the assets so subject to the Lien; (g) obligations of such Person arising under acceptance facilities or under facilities for the discount of accounts receivable of such Person; (h) any obligation of such Person to reimburse the issuer of any letter of credit issued for the account of such Person upon which a draw has been made; and (i) any lease having the effect of indebtedness, whether or not the same shall be treated as such on the balance sheet of Borrower under GAAP. "FUNDING DATE" means with respect to any proposed Loan hereunder, the date funds are advanced to Borrower for such Loan. "GAAP" means generally accepted accounting principles set forth in the opinions and pronouncements of the Accounting Principles Board of the American Institute of Certified Public Accountants and statements and pronouncements of the Financial Accounting Standards Board 3. 14 or in such other statements by such other Person as may be approved by the significant segment of the accounting profession, which are applicable to the circumstances as of the date of determination. "GUARANTY" means a Guaranty made by each domestic Subsidiary, in favor of Lender. "JCC" means the Joint Commercialization Committee as defined in Section 1.36 of the Collaboration Agreement and appointed pursuant to the Collaboration Agreement. "JDC" means the Joint Development Committee as defined in Section 1.37 of the Collaboration Agreement and appointed pursuant to the Collaboration Agreement. "LIEN" means any mortgage, pledge, security interest, lien or other charge or encumbrance, including the lien or retained security title of a conditional vendor, upon or with respect to any property or assets. "LIQUIDITY" means the value of Borrower's cash, cash equivalents and short-term investments (less restricted cash), plus [....***....] of net trade receivables payable to Borrower by Lender, plus [...***...] of net trade receivables payable to Borrower by Persons other than Lender. "LOAN" and "LOANS" has the meaning set forth in SECTION 2. "LOAN DOCUMENTS" means this Loan Agreement, the Note and the Security Agreement dated as of the date first written above, each as executed by Borrower in favor of Lender, together with all other documents entered into or delivered pursuant to any of the foregoing, including, without limitation, each Guaranty, in each case as originally executed or as the same may from time to time be supplemented, modified or amended. "MATURITY DATE" has the meaning set forth in SECTION 2. "OBLIGATIONS" means all loans, advances, debts, liabilities and obligations, for monetary amounts owing by Borrower to Lender, whether due or to become due, matured or unmatured, liquidated or unliquidated, contingent or non-contingent, and all covenants and duties regarding such amounts, of any kind or nature, present or future, whether or not evidenced by any note, agreement or other instrument, arising under any of the Loan Documents. This term includes, without limitation, all principal, interest (including interest that accrues after the commencement against Borrower under the Bankruptcy Code), fees, including, without limitation, any and all arrangement fees, closing fees, prepayment fees, commitment fees, advisory fees, agent fees and attorneys' fees and any and all other fees, expenses, costs or other sums (including all reasonable fees and disbursements of any law firm or other external counsel to Lender) chargeable to Borrower under any of the Loan Documents. *Confidential Treatment Requested 4. 15 "PERMITTED INDEBTEDNESS" means the following: (1) Indebtedness of Borrower or Subsidiaries in favor of Lender arising under this Loan Agreement and the other Loan Documents; (2) the existing or anticipated Funded Indebtedness disclosed on SCHEDULE 1 attached hereto and incorporated herein by this reference; provided that the principal amount thereof is not increased and the terms thereof are not modified to impose more burdensome terms upon Borrower or any of its Subsidiaries; (3) the Subordinated Debt; (4) extensions, renewals or refinancings of Funded Indebtedness permitted under this Loan Agreement; (5) accrued dividends on the preferred stock of Borrower; (6) interest rate and currency hedging agreements; (7) guaranties of any Subsidiary's suppliers in connection with the purchase of supplies in the ordinary course of business; (8) [...***...] in the [...***...] and to the extent otherwise permitted hereunder; and (9) Funded Indebtedness secured by Permitted Liens. "PERMITTED LIENS" means the following: (1) Liens existing as of this date or anticipated, and disclosed in Schedule 2 attached hereto and incorporated herein by this reference; (2) Liens for taxes, fees, assessments or other governmental charges or levies, either not delinquent or being contested in good faith by appropriate proceedings; (3) Liens (a) upon or in [...***...] (other than [...***...] in [...***...] of the [...***...]) [...***...] by Borrower to secure the [...***...] of [...***...] for the purpose of [...***...] of [...***...] and in [...***...] the [...***...] thereof or (b) existing on [...***...], provided that the Lien is [...***...] to the [...***...] and [...***...] and the [...***...] of such [...***...]; (4) Liens consisting of leases or subleases and licenses and sublicenses granted to others in the ordinary course of Borrower's business not interfering in any material respect with the business of Borrower and any interest or title of a lessor or licensor under any lease or license, as applicable; *Confidential Treatment Required 5. 16 (5) Liens securing claims or demands of materialmen, mechanics, carriers, warehousemen, landlords and other like persons or entities imposed without action of such parties, provided that the payment thereof is not yet required; (6) Liens incurred or deposits made in the ordinary course of Borrower's business in connection with worker's compensation, unemployment insurance, social security and other like laws; (7) Liens arising from judgments, decrees or attachments in circumstances not constituting an Event of Default; (8) Easements, reservations, rights-of-way, restrictions, minor defects or irregularities in title and other similar charges or encumbrances affecting real property not interfering in any material respect with the ordinary conduct of Borrower's business; (9) Liens in favor of customs and revenue authorities arising as a matter of law to secure payment of customs duties in connection with the importation of goods; (10) Liens which constitute rights of set-off of a customary nature; (11) Any interest or title of a lessor in equipment subject to any Capital Lease otherwise permitted hereunder; and (12) Any Liens arising from the filing of any financing statements relating to true leases otherwise permitted hereunder. "PERSON" means any individual, sole proprietorship, partnership, joint venture, trust, unincorporated organization, association, corporation, limited liability company, institution, public benefit corporation, firm, joint stock company, estate, entity or governmental agency. "PRIME RATE" means the rate of interest that Bank of America N.T & S.A. has announced as its prime lending rate on the last Business Day of the calendar quarter immediately preceding a Loan advance, or if such rate is not available, the prime rate of interest as printed in the Wall Street Journal, Western Edition on the Last Business Day of such calendar quarter. "PROPERTY" means any interest in any kind of property or asset, whether real, personal or mixed, whether tangible or intangible. "REMAINING MONTHS LIQUIDITY" means the ratio of (a) Liquidity to (b) the average monthly change in net cash from Borrower's operations during the prior three (3) month period; provided, however, that the impact of any manufacturing or annual campaigns shall be annualized for purposes hereof. "SECURITY AGREEMENT" means that certain Security Agreement dated of even date herewith, made by Borrower in favor of Lender. 6. 17 "SENIOR LENDER" has the meaning set forth in SCHEDULE 1 to EXHIBIT A of the Loan Agreement. "SUBORDINATED DEBT" means indebtedness of Borrower, the repayment of principal of which is fully subordinated in time and right of payment to the Loans, and has been approved in Lender's sole and absolute discretion and in writing. "SUBSIDIARIES" means each entity controlled, directly or indirectly, by Borrower now existing or hereafter formed or acquired. 7. 18 SCHEDULE 1 TO EXHIBIT A SPECIFIC PERMITTED INDEBTEDNESS 1. Any and all Funded Indebtedness owing by Borrower to any Person engaged in the lending of money in the ordinary course of business (each, a "SENIOR LENDER"), in an aggregate principal amount with respect to all such Senior Lenders not to exceed U.S. [...***...], which Liens may include a first priority security interest in certain personal property of Borrower except the Licensed Patents (as defined in the Security Agreement) and Know-How (as defined in the Security Agreement) and the Equipment of Borrower described in Section 2(a)(ii) of the Security Agreement. This Schedule 1 shall be updated by Borrower with respect to the identity of the Senior Lender(s) once this identity has been established. 2. Equipment Lease Financing Agreement dated as of December 6, 1996, between Borrower and Lease Management Services, Inc. 3. Letter of Credit pursuant to the Lease Agreement dated November 7, 1997, by and between HMS Gateway Office L.P. and Borrower. *CONFIDENTIAL TREATMENT REQUESTED 8. 19 SCHEDULE 2 TO EXHIBIT A SPECIFIC PERMITTED LIENS 1. Liens granted to any Person or Persons to secure the Permitted Indebtedness disclosed in SCHEDULE 1 to EXHIBIT A. 2. Liens granted pursuant to the Facilities Agreement between MDS Nordion, Inc. and Borrower dated August 31, 1998. 1. 20 EXHIBIT B COMPLIANCE CERTIFICATE COULTER PHARMACEUTICAL, INC. (the "Company") hereby certifies that: This Compliance Certificate is furnished pursuant to SECTION 9 of the Loan Agreement dated as of October 23, 1998 (the "Loan Agreement"), by and among the Company and SmithKline Beecham Corporation ("Lender"). Unless otherwise defined herein, the terms used in this Certificate have the meanings given them in the Loan Agreement. As required by SECTIONS 9(a) and 9(b), as applicable, of the Loan Agreement, consolidated financial statements of the Company for the [year/quarter] ended _______________ (the "Financial Statements") prepared in accordance with generally accepted accounting principles consistently applied accompany this Compliance Certificate. The Financial Statements present fairly the consolidated financial position of the Company as at the date thereof and the consolidated results of operations of the Company for the period covered thereby (subject only to normal recurring year-end adjustments). The figures set forth in SCHEDULE 1 attached hereto to be submitted quarterly for determining compliance by the Company with the financial covenants and certain other covenants contained in SECTION 8 of the Loan Agreement are true and complete as of the date first written above. The activities of the Company during the period covered by the Financial Statements have been reviewed by the chief financial officer or by employees or agents under his/her immediate supervision. Based on such review, to the best knowledge and belief of the chief financial officer, and as of the date of this Compliance Certificate, no Event of Default has occurred. WITNESS my hand this _____ day of _______________, ____. COULTER PHARMACEUTICAL, INC. By: --------------------------------- Printed Name: ----------------------- Title: Chief Financial Officer 1. 21 SCHEDULE 1 TO EXHIBIT B FINANCIAL COVENANTS A. MINIMUM REMAINING MONTHS LIQUIDITY (SECTION 8.A.) REQUIRED: Until such time as Borrower maintains a Debt Service Coverage Ratio of not less than [...***...] for two (2) consecutive Fiscal Quarters, Borrower shall maintain Remaining Months Liquidity of six (6) months. ACTUAL: (1) Cash $___________ (2) Cash equivalents and short-term $___________ investments (less restricted cash) (3) [**] of net trade receivables payable $___________ by Lender (4) [**] of net trade receivables payable by $___________ Persons other then Lender (5) Sum of Lines (1) - (4) $___________ (6) Average monthly change in net cash from $___________ Borrower's operations during preceding three months (7) Line (5) divided by Line (6) _________ MONTHS In Compliance Yes ? No ? B. MINIMUM DEBT SERVICE COVERAGE RATIO (SECTION 8.B.) REQUIRED: Borrower shall maintain a Debt Service Coverage Ratio of not less than [...***...]. ACTUAL: (1) Net Profit $___________ (2) Depreciation $___________ (3) Amortization and other non-cash charges $___________ (4) Sum of Lines (1) - (3) $___________ (5) Current portion of long-term debt $___________ (6) Line (4) divided by Line (5) $___________
*CONFIDENTIAL TREATMENT REQUESTED 1. 22 In Compliance Yes ? No ? C. MINIMUM CONSOLIDATED TANGIBLE NET WORTH (SECTION 8.C.) REQUIRED: Borrower on a consolidated basis shall not permit the Consolidated Tangible New Worth to be an amount less than [...***...]. ACTUAL: (1) Consolidated Total Assets $___________ (2) Intangible assets $___________ (3) Consolidated Total Liabilities $___________ (4) Total: Line (1) minus Line (2) $___________ minus Line (3) In Compliance Yes ? No ? D. CONSOLIDATED LEVERAGE RATIO (SECTION 8.D.) REQUIRED: Borrower on a consolidated basis shall not permit the Consolidated Leverage Ratio to be greater than [...***...]. ACTUAL: (1) Consolidated Total Liabilities $___________ (2) Consolidated Total Assets $___________ (3) Intangible assets $___________ (4) Line (2) minus Line (3) $___________ (5) Line (1) divided by Line (4) $ : =========== [...***...] In Compliance Yes ? No ?
WITNESS my hand on this Compliance Certificate on this _____ day of _______________,______. *CONFIDENTIAL TREATMENT REQUESTED 2. 23 COULTER PHARMACEUTICAL, INC. By: --------------------------------- Printed Name: -------------------- Title: Chief Financial Officer 3. 24 EXHIBIT C COMPLIANCE CERTIFICATE CONDITIONS PRECEDENT TO LOAN COULTER PHARMACEUTICAL, INC. (the "Company") hereby certifies that: This Compliance Certificate is furnished pursuant to SECTION 4 of the Loan Agreement dated as of October 23, 1998 (the "Loan Agreement"), by and among the Company and SmithKline Beecham Corporation ("Lender"). Unless otherwise defined herein, the terms used in this Certificate have the meanings given them in the Loan Agreement. Concurrently with delivery of this Compliance Certificate, the Company has requested an advance under the Loan Agreement. The activities of the Company during the period covered by the Financial Statements for the most recently completed calendar quarter (i.e., March 31, June 30, September 30, or December 31) have been reviewed by the chief financial officer or by employees or agents under his/her immediate supervision. Based on such review, to the best knowledge and belief of the chief financial officer, as of the date of this Compliance Certificate the Borrower satisfies each of the conditions precedent to the requested advance as set forth in SECTIONS 4(a) through 4(e) of the Loan Agreement. WITNESS my hand this _____ day of _______________, ____. COULTER PHARMACEUTICAL, INC. By: --------------------------------- Printed Name: ----------------------- Title: Chief Financial Officer 1. 25 EXHIBIT D FORM OF GUARANTY TO BE EXECUTED BY BORROWER'S DOMESTIC SUBSIDIARIES XYZ COMPANY, INC. ("GUARANTOR") SMITHKLINE BEECHAM CORPORATION ("LENDER") 1. From and after the date hereof, Guarantor hereby unconditionally guarantees the due and punctual payment of the principal and interest and all other amounts due under the Loan Agreement between Coulter Pharmaceutical, Inc. ("Borrower") and Lender dated October 23, 1998 (the "Loan Agreement"), as and when the same shall become due and payable, whether by acceleration or otherwise, and the timely performance of all other obligations of Borrower under the Loan Agreement (each a "Guarantee Obligation"); provided however, that Guarantor shall not be liable to pay or perform any Guarantee Obligation until 5 business days following receipt by Guarantor of written notice from Lender that payment or performance of such Guarantee Obligation is due. 2. Guarantor's obligations hereunder are absolute and unconditional, irrespective of the validity, regularity or enforceability of the Loan Agreement or any other documents or agreements between Borrower and Lender, any change therein or amendment thereto, the absence of any action to enforce the same, any waiver or consent by Lender with respect to any provision thereof, the recovery of any judgment against Borrower or any action to enforce the same, or any other circumstances which may otherwise constitute a legal or equitable discharge or defense of a guarantor; it being the intent and purpose hereof that the obligation and liability of Guarantor hereunder shall not be impaired, diminished, abated or otherwise affected by any setoff, defense or counterclaim that [Borrower] or Guarantor may have or claim to have, at any time or from time to time, against Lender or any other person or by the commencement by or against [Borrower] or Guarantor of any proceedings under any bankruptcy or insolvency law or laws, that Guarantor shall not be entitled to, and does hereby waive, any and all defenses available to guarantors, sureties and other secondary parties at law or in equity, and that Guarantor shall pay to Lender, as a payment obligation directly due from Guarantor to Lender, amounts equal to all amounts which Lender shall fail to properly pay when due under the Loan Agreement. Upon payment by Guarantor of any sums to Lender hereunder, all rights of Guarantor against Lender for reimbursement, whether arising by way of any statutory, contractual or other right of subrogation, exoneration, contribution, indemnification or otherwise, shall in all respects be subordinate and junior in right of payment to the prior indefeasible payment and performance in full of all the Guarantee Obligations. Guarantor waives all presentments, demands for performance, notices of nonperformance, protests, notices of protest, notices of dishonor, notices of acceptance of this Guaranty and of the Guarantee Obligations; provided however, that nothing contained in this paragraph 2 shall constitute a waiver by Guarantor of the notice requirement contained in paragraph 1. This Guaranty will not terminate or be discharged except upon the full and indefeasible payment and performance of the Guarantee Obligations and the obligations of Guarantor hereunder. 1. 26 3. Guarantor waives any right to require Lender to: (a) proceed against Lender or any other guarantor of the Guarantee Obligations; (b) proceed against or exhaust any security held from Borrower; (c) pursue any other remedy in Lender's power whatsoever; (d) comply with any appraisement, valuation, stay, extension, moratorium, redemption or similar law or similar rights for marshaling; or (e) notify Guarantor as to the financial condition of Borrower or any other guarantor of the Guarantee Obligation or of any circumstance that may bear upon the risk of nonpayment or nonperformance of the Borrower's obligations. 4. Guarantor agrees that, in the event any payment or transfer made by or on behalf of Borrower in respect of any of the Guarantee Obligations, or any portion thereof, shall at any time be avoided or be returned by Lender pursuant to any order (whether or not final) by a court of competent jurisdiction, or any provision of the United States Bankruptcy Code, as now existing or hereafter amended, or other applicable law, then the Guarantee Obligations shall not be deemed to have been satisfied to the extent of the avoided or returned payment or transfer, and the obligations of Guarantor hereunder shall continue in full force and effect or be revived and reinstated, as the case may be, all as though such payment or transfer had not been made. 5. Guarantor represents and warrants that: (a) this Guaranty has been duly executed and delivered by it and constitutes the legal, valid and binding obligation of Guarantor, enforceable in accordance with its terms and (b) Guarantor has, independently and without reliance on Lender and based on such documents and information as it had deemed appropriate, made its own credit analysis and decision to enter into this Guaranty, and Guarantor has established adequate means of obtaining from Lessee on a continuing basis information pertaining to, and is now and on a continuing basis will be completely familiar with, the financial condition, operations, properties and prospects of Borrower. 6. Guarantor shall be liable for all reasonable attorneys' fees and other costs and expenses incurred by reason of any default or the exercise of Lender's remedies thereunder. 7. The obligations of Guarantor thereunder are independent of the obligations of Borrower. A separate action or actions may be brought and prosecuted against Guarantor, whether an action is brought against Borrower or any other guarantor of the Guarantee Obligations or whether Borrower or any such other guarantor be joined in any such action or actions. 8. Notices, demands and other communications hereunder shall (a) be in writing, (b) be delivered personally or sent by mail, overnight courier or facsimile to the intended recipient at (i) if to Lender, SMITHKLINE BEECHAM CORPORATION, ONE FRANKLIN PLAZA (FP1935), PHILADELPHIA, PA 19102, Attention: ________________ (Fax No.: (215) 751-4253) and (ii) if to Guarantor, at the address set forth beneath its name below, or in each case to such other address noticed as herein provided by the recipient to the other party, and (c) be effective on receipt if delivered personally or by facsimile, three days after dispatch if mailed and one business day after dispatch if sent by courier. 9. Neither party may assign or transfer this Guaranty or any rights or obligations hereunder without the prior written consent of the other which shall not be unreasonably 2. 27 withheld, except a party may make such an assignment without the other party's consent to an Affiliate (as defined in the Loan Agreement) or to a successor to substantially all of the pharmaceutical business of such party, whether in a merger, sale of stock, sale of assets or other transaction. Any permitted successor or assignee of rights and/or obligations hereunder shall, in a writing to the other party, expressly assume performance of such rights and/or obligations. Any permitted assignment shall be binding on the successors of the assigning party. Any assignment or attempted assignment by either party in violation of the terms of this Section 9 shall be null and void and of no legal effect. This Guaranty may not be amended or modified, nor may any of its terms be waived, except by written instruments signed by Lender and Guarantor. Each waiver or consent shall be effective only in the specific instances for the purpose for which given. If at any time any provision of this Guaranty is or becomes illegal, invalid or unenforceable in any respect under the law of any jurisdiction, neither the illegality, validity or enforceability of the remaining provisions of this Guaranty nor the legality, validity or enforceability of such provision under the law of any other jurisdiction shall in any way be affected or impaired thereby. This Guaranty shall be governed by, and construed in accordance with, the laws of the Commonwealth of Delaware (without giving effect to principles of conflicts of laws). GUARANTOR AND LENDER, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, HEREBY IRREVOCABLY WAIVE THE RIGHT TO TRIAL BY JURY AS TO ANY ISSUE RELATING HERETO IN ANY ACTION, PROCEEDING OR COUNTERCLAIM ARISING OUT OF OR RELATING TO THIS GUARANTY. 3. 28 In Witness Whereof, the undersigned has duly executed this Guaranty as of __________________. GUARANTOR: [--------------------] By: -------------------------------- Title: ----------------------------- Address: --------------------------- ----------------------------------- ----------------------------------- ----------------------------------- Attention: ------------------------- Fax: ------------------------------- 4.
EX-10.25 6 COLLABORATION AGREEMENT / SMITHKLINE BEECHAM 1 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. EXHIBIT 10.25 COLLABORATION AGREEMENT BETWEEN COULTER PHARMACEUTICAL, INC. AND SMITHKLINE BEECHAM CORPORATION MARCH 26, 1999 2 TABLE OF CONTENTS
PAGE ARTICLE 1 DEFINITIONS...................................................................1 1.1 "004 Trial"...................................................................1 1.2 "Additional Indications"......................................................1 1.3 "Affiliate(s)"................................................................1 1.4 "Anti-CD20 Antibody"..........................................................2 1.5 "B1 Murine Antibody"..........................................................2 1.6 "Bexxar"......................................................................2 1.7 "BLA".........................................................................2 1.8 "Commercially Reasonable Efforts".............................................2 1.9 "Control".....................................................................2 1.10 "Co-Promotion"................................................................3 1.11 "Cost of Goods"...............................................................3 1.12 "Coulter Patent Rights".......................................................4 1.13 "Cross-Territory Trials"......................................................4 1.14 "Development".................................................................4 1.15 "Development Costs"...........................................................4 1.16 "Distribution Costs"..........................................................5 1.17 "Europe"......................................................................5 1.18 "European Facility"...........................................................5 1.19 "Existing Third Party License"................................................5 1.20 "Existing Third Party License Costs"..........................................6 1.21 "FD&C Act"....................................................................6 1.22 "FDA".........................................................................6 1.23 "Field".......................................................................6 1.24 "Finance Subteam".............................................................6 1.25 "First Commercial Sale".......................................................6 1.26 "First Indication"............................................................6 1.27 "Force Majeure Occurrence"....................................................6 1.28 "FTE".........................................................................6
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. i. 3 TABLE OF CONTENTS (CONTINUED)
PAGE 1.29 "Good Clinical Practice" or "GCP".............................................6 1.30 "Good Laboratory Practice" or "GLP"...........................................7 1.31 "Good Manufacturing Practice" or "GMP"........................................7 1.32 "Guaranteed COGS Plus Royalties Percent"......................................7 1.33 "Guaranteed COGS Territory"...................................................7 1.34 "Intellectual Property Rights"................................................7 1.35 "Invention"...................................................................7 1.36 "Joint Commercialization Committee" or "JCC"..................................7 1.37 "Joint Development Committee" or "JDC"........................................7 1.38 "Joint Development Plan"......................................................7 1.39 "Joint Manufacture Development Plan"..........................................8 1.40 "Joint Marketing Plan"........................................................8 1.41 "Joint P&L"...................................................................8 1.42 "Know-How"....................................................................8 1.43 "Licensed Compound"...........................................................8 1.44 "Loan and Security Agreements"................................................8 1.45 "MAA".........................................................................8 1.46 "Major Indications"...........................................................9 1.47 "Major Market Country"........................................................9 1.48 "Major Markets in Territory C"................................................9 1.49 "Manufacture and Supply Chain Subteam"........................................9 1.50 "Manufacture Development".....................................................9 1.51 "Manufacture Development Costs"...............................................9 1.52 "Marketing Costs"............................................................10 1.53 "[*]"........................................................................11 1.54 "Net Sales"..................................................................11 1.55 "New Third Party Manufacture and Supply Chain Agreements"....................11 1.56 "New Third Party License"....................................................11 1.57 "New Third Party License Costs"..............................................12
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. ii. 4 TABLE OF CONTENTS (CONTINUED)
PAGE 1.58 "Non-USA COGS"...............................................................12 1.59 "Non-USA Marketing Plan".....................................................12 1.60 "Non-USA Territory"..........................................................12 1.61 "North America"..............................................................12 1.62 "Operating Profit or Loss"...................................................12 1.63 "Other Operating Income/Expense".............................................12 1.64 "Out-of-Pocket Costs"........................................................12 1.65 "Patent Costs"...............................................................12 1.66 "Patent Rights"..............................................................12 1.67 "PHS Act"....................................................................13 1.68 "Planned Clinical Trials"....................................................13 1.69 "Pre-Existing Third Party Manufacture and Supply Chain Agreements"...........13 1.70 "Product"....................................................................13 1.71 "QA/QC Costs"................................................................13 1.72 "Radiolabeled Antibody"......................................................14 1.73 "Regulatory Approval"........................................................14 1.74 "Regulatory Personnel".......................................................14 1.75 "Sales Costs"................................................................14 1.76 "Sales Effort"...............................................................14 1.77 "SB Option Exercise Notice"..................................................14 1.78 "SB Patent Rights"...........................................................14 1.79 "Second Generation Antibody".................................................14 1.80 "Second Generation Antibody Candidate".......................................14 1.81 "Second Generation Licensed Compound"........................................15 1.82 "Second Generation Licensed Compound Candidate"..............................15 1.83 "Second Generation Licensed Compound Candidate Development Costs"............15 1.84 "Second Generation Licensed Compound Candidate Manufacture Development Costs".......................................................................16 1.85 "Second Indication"..........................................................16
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. iii. 5 TABLE OF CONTENTS (CONTINUED)
PAGE 1.86 "Stock Purchase Agreement"...................................................16 1.87 "Term of Co-Promotion".......................................................16 1.88 "Territory"..................................................................16 1.89 "Territory A"................................................................16 1.90 "Territory B"................................................................16 1.91 "Territory C"................................................................16 1.92 "Third Indication"...........................................................16 1.93 "Third Party(ies)"...........................................................17 1.94 "Trademark"..................................................................17 1.95 "Trademark Costs"............................................................17 1.96 "Unaffiliated Expert"........................................................17 1.97 "Unconjugated Antibody"......................................................17 ARTICLE 2 MANAGEMENT OF COLLABORATION..................................................17 2.1 Joint Development Committee (JDC)............................................17 2.1.1 Formation; Membership.................................................17 2.1.2 Decision-Making.......................................................18 2.1.3 Meetings..............................................................18 2.1.4 Specific Responsibilities of the JDC..................................18 2.2 Joint Commercialization Committee (JCC)......................................19 2.2.1 Formation; Membership.................................................19 2.2.2 Decision-Making.......................................................20 2.2.3 Meetings..............................................................20 2.2.4 Specific Responsibilities of the JCC..................................20 2.3 Manufacture and Supply Chain Subteam.........................................21 2.3.1 Formation; Membership.................................................21 2.3.2 Decision-Making.......................................................22 2.3.3 Meetings..............................................................22 2.3.4 Specific Responsibilities of the Manufacture and Supply Chain Subteam...............................................................22
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. iv. 6 TABLE OF CONTENTS (CONTINUED)
PAGE 2.4 Finance Subteam..............................................................23 2.4.1 Formation; Membership.................................................23 2.4.2 Meetings..............................................................23 2.4.3 Responsibilities of the Finance Subteam...............................23 ARTICLE 3 DEVELOPMENT OF LICENSED COMPOUND.............................................24 3.1 Initial and Subsequent Focus of the Collaboration............................24 3.2 Development..................................................................24 3.2.1 Joint Development Plan................................................24 3.2.2 Implementation of Development.........................................25 3.2.3 Designation of Clinical Trials........................................26 3.2.4 Lead Party for Development............................................26 3.2.5 Development Diligence Milestones in Non-USA Territory.................27 3.2.6 Funding of Development................................................28 3.3 Manufacture Development......................................................30 3.3.1 Joint Manufacture Development Plan....................................30 3.3.2 Lead Party for Manufacture Development................................31 3.3.3 Funding of Manufacture Development....................................32 3.4 Records, Reports and Information Exchange....................................32 3.4.1 Technology and Information Transfer...................................32 3.4.2 Record Keeping........................................................33 3.5 Regulatory Compliance........................................................33 3.6 Regulatory Approvals.........................................................33 3.6.1 Territory A...........................................................33 3.6.2 Non-USA Territory.....................................................33 ARTICLE 4 ADDITIONAL INDICATIONS; SECOND GENERATION LICENSED COMPOUNDS.................34 4.1 Additional Indications.......................................................34 4.2 Second Generation Licensed Compounds.........................................35 4.2.1 Second Generation Licensed Compound Candidates; Reporting; Notice................................................................35
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. v. 7 TABLE OF CONTENTS (CONTINUED)
PAGE 4.2.2 SB Development and Commercialization Option...........................36 4.2.3 If Coulter is the Initiating Party and SB Does Not Provide an SB Option Exercise Notice.............................................37 4.2.4 Coulter Development and Commercialization Rights; Coulter Funding Option........................................................38 4.2.5 Modification of Joint Development Plan, Joint Manufacture Development Plan and Joint Marketing Plan.............................39 ARTICLE 5 LICENSES.....................................................................40 5.1 Licenses to SB...............................................................40 5.2 Licenses to Coulter..........................................................41 5.3 New Third Party Licenses.....................................................42 5.3.1 Determination Regarding Need for New Third Party License..............42 5.3.2 Procedure for Obtaining...............................................42 5.3.3 New Third Party License Costs.........................................43 5.3.4 Upstream Licenses.....................................................43 5.4 Exclusivity..................................................................44 ARTICLE 6 CONSIDERATION TO COULTER.....................................................46 6.1 Upfront Fees.................................................................46 6.2 Milestone Payments on Bexxar.................................................47 6.2.1 Definitions Relating to Milestone Payments............................50 6.2.2 Delay of Commercial Launch in Non-USA Territory.......................52 6.2.3 Non-Refundable and Non-Creditable Milestone Payments..................52 6.2.4 Offset Against Milestone Payment for Regulatory Approval in Territory B...........................................................52 6.3 Milestone Payments on Products Containing Second Generation Licensed Compounds....................................................................52 6.4 Section 9.10.5 Milestone.....................................................53 6.5 Method of Making Milestone Payments..........................................53 6.6 Royalties and Profit Sharing.................................................53 6.7 [*] Rights...................................................................54
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. vi. 8 TABLE OF CONTENTS (CONTINUED)
PAGE ARTICLE 7 MARKETING....................................................................55 7.1 Co-Promotion in Territory A..................................................55 7.1.1 Rights to Co-Promote..................................................55 7.1.2 Lead Party for Commercialization in Territory A.......................55 7.1.3 Joint Marketing Plan..................................................56 7.1.4 Product Team..........................................................56 7.1.5 Product Pricing.......................................................56 7.1.6 Efforts of the Parties................................................57 7.1.7 Compliance with Law...................................................58 7.1.8 Promotional and Advertising Materials.................................59 7.1.9 Samples...............................................................59 7.1.10 Orders, Distribution, Completion of Sales, Returns....................59 7.1.11 Exchange of Marketing Information.....................................60 7.1.12 Co-Promotion Expenses.................................................60 7.1.13 Allocation of Operating Profit or Loss................................60 7.1.14 Joint P&L.............................................................60 7.1.15 Election to Forego Co-Promotion Right.................................61 7.1.16 Sales Training........................................................62 7.2 Non-USA Territory............................................................63 7.2.1 General...............................................................63 7.2.2 Commercialization Milestones..........................................63 7.2.3 Third Party Distribution Agreements...................................65 7.2.4 Royalties in Non-USA Territory........................................65 7.2.5 Increase or Decrease in Royalties based on Non-USA COGS...............66 7.2.6 Decrease in Royalties Based on Substantial Competition................68 7.3 No Delegation................................................................68 7.4 Product Complaints...........................................................68 7.5 Product-Related Inquiries....................................................69 7.6 Adverse Drug Event Reporting.................................................69
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. vii. 9 TABLE OF CONTENTS (CONTINUED)
PAGE ARTICLE 8 ACCOUNTS AND RECORDS; WITHHOLDING TAX........................................69 8.1 No Double Counting of Costs..................................................69 8.2 Records......................................................................69 8.3 Audits.......................................................................69 8.4 Sales by Sublicensees........................................................70 8.5 Withholding..................................................................70 8.6 Currency of Payment..........................................................70 8.7 Accounting...................................................................71 ARTICLE 9 MANUFACTURING AND SUPPLY.....................................................71 9.1 Cooperation..................................................................71 9.2 Pre-Existing Third Party Manufacture and Supply Chain Agreements.............71 9.3 Conformity with Pre-Existing Third Party Manufacture and Supply Chain Agreements and Any New Third Party Manufacture and Supply Chain Agreements...................................................................72 9.4 Responsibility for Manufacture, Supply and Distribution......................72 9.4.1 Unconjugated Antibody.................................................72 9.4.2 Radiolabeled Antibody for Development.................................72 9.4.3 Radiolabeled Antibody for Commercial Sale.............................73 9.4.4 Specifications........................................................73 9.4.5 Non-compliance with Specifications....................................73 9.4.6 Distribution..........................................................75 9.5 Allocation in the Event of Product Shortages.................................75 9.5.1 Allocation Between Development and Commercialization..................75 9.5.2 Allocation of Shortages Between Territories (Commercial Supply).......75 9.5.3 No Liability for Product Shortages....................................75 9.6 Change in Responsibility for Manufacture and Supply..........................75 9.6.1 Unconjugated Antibody by SB...........................................75 9.6.2 Unconjugated Antibody or Radiolabeled Antibody by Coulter.............76
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. viii. 10 TABLE OF CONTENTS (CONTINUED)
PAGE 9.7 Cost of Goods for Unconjugated Antibody and Radiolabeled Antibody for Development and Manufacture Development; Manufacture Development Costs (Including Capital Expenditures).............................................77 9.7.1 Cost of Goods for Unconjugated Antibody and Radiolabeled Antibody for Development and Manufacture Development..................77 9.7.2 Manufacture Development Costs (Including [*]).........................77 9.8 Cost of Goods for Unconjugated Antibody and Radiolabeled Antibody for Commercial Sale..............................................................77 9.8.1 Unconjugated Antibody.................................................77 9.8.2 Radiolabeled Antibody.................................................78 9.9 Cost of Unconjugated Antibody in Event of Transfer of Responsibility.........79 9.10 European Facility............................................................79 9.10.1 Overview..............................................................79 9.10.2 Selection of SB Option................................................80 9.10.3 Definitions...........................................................81 9.10.4 SB Performance; Coulter Remedies......................................81 9.10.5 Milestone Payment.....................................................82 9.10.6 Remainder of the Non-USA Territory....................................83 9.11 Term of Manufacture and Supply...............................................83 9.12 Forecasts....................................................................83 9.12.1 Unconjugated Antibody and Radiolabeled Antibody.......................83 9.12.2 Production Ordering Mechanism for Radiolabeled Antibody for Development and Commercial Sale.......................................84 9.12.3 Delivery; Shipment....................................................84 9.13 Quality Control; Testing.....................................................85 9.14 Manufacturing Regulatory Compliance..........................................85 9.14.1 Territory A...........................................................85 9.14.2 Territory B and Territory C...........................................85 9.15 Recalls......................................................................85 9.16 Corrective Action for Supply of Unconjugated Antibody........................86
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. ix. 11 TABLE OF CONTENTS (CONTINUED)
PAGE 9.17 Corrective Action for Supply of Radiolabeled Antibody........................87 9.18 Exchange of Information......................................................87 ARTICLE 10 TRADEMARKS...................................................................88 10.1 Selection and Ownership of Trademarks........................................88 10.1.1 Territory A...........................................................88 10.1.2 Non-USA Territory.....................................................88 10.2 Development of Trademarks....................................................88 10.3 License Grants...............................................................89 10.3.1 Territory A...........................................................89 10.3.2 Non-USA Territory.....................................................89 10.3.3 Licensed Trademarks...................................................89 10.4 Use of Trademarks............................................................89 10.4.1 Territory A Trademarks and Coulter Trademarks.........................89 10.4.2 SB Trademarks.........................................................90 10.4.3 Quality Maintenance...................................................90 10.5 Infringement of Trademarks...................................................90 10.6 Costs Related to Infringement................................................91 10.7 Trade Dress..................................................................91 ARTICLE 11 PROSECUTION, MAINTENANCE AND INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS.......................................................................92 11.1 Inventions...................................................................92 11.2 Prosecution And Maintenance Of Patent Rights; Allocation of Patent Costs.....93 11.3 Cooperation..................................................................93 11.4 Infringement of Intellectual Property Rights.................................93 11.4.1 Right to Bring Action; Treatment of Recovery..........................93 11.5 Defense and Settlement of Third Party Claims for Products in the Territory; Opposition and Revocation Proceedings.............................95 11.7 Royalty Reduction in Territory B or Territory C..............................97 11.8 Foreclosure Under Security Agreement.........................................97
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. x. 12 TABLE OF CONTENTS (CONTINUED)
PAGE 11.9 Covenant Regarding Existing Third Party License Agreements with [*].........100 ARTICLE 12 FORCE MAJEURE...............................................................101 ARTICLE 13 TERM AND TERMINATION........................................................101 13.1 Term........................................................................101 13.2 General Conditions of Expiration and Termination............................102 13.3 Termination for Breach......................................................104 13.3.1 General..............................................................104 13.3.2 Breach by SB.........................................................104 13.4 Early Termination License of SB's License...................................104 13.5 Non-Exclusive License.......................................................105 13.6 Early Termination of Coulter's License......................................106 13.7 No Limit on Remedies........................................................107 ARTICLE 14 ASSIGNMENT..................................................................107 14.1 Assignment..................................................................107 14.2 Performance by Affiliates and Local Operating Entities......................107 ARTICLE 15 INDEMNIFICATION AND INSURANCE...............................................107 15.1 Cross Indemnification.......................................................107 15.1.1 Indemnification in the Non-USA Territory.............................107 15.1.2 Indemnification in Territory A.......................................108 15.2 Indemnification Procedure...................................................109 15.3 Insurance...................................................................109 ARTICLE 16 WARRANTIES AND REPRESENTATIONS...........................................110 ARTICLE 17 CONFIDENTIAL INFORMATION.................................................112 17.1 Information.................................................................112 17.2 Exceptions..................................................................112 17.3 Permitted Disclosures.......................................................113 17.4 Disclosure of Agreement.....................................................113 17.5 Publicity...................................................................114 17.6 Publication.................................................................114
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. xi. 13 TABLE OF CONTENTS (CONTINUED)
PAGE 17.7 Prior Confidentiality Agreements............................................114 ARTICLE 18 DISPUTE RESOLUTION..........................................................115 18.1 General.....................................................................115 18.2 [*].........................................................................115 18.3 Recommendation of [*].......................................................115 18.4 Governing Law; Jurisdiction; Venue..........................................116 18.5 Arbitration for Reasonable Royalty Determination............................116 ARTICLE 19 MISCELLANEOUS...............................................................117 19.1 Conditions to Effectiveness.................................................117 19.2 No Waiver of Contractual Rights.............................................118 19.3 Execution and Amendments....................................................118 19.4 Severability................................................................118 19.5 Relationship between the Parties............................................119 19.6 Correspondence and Notices..................................................119 19.7 Counterparts................................................................120 19.8 Waiver Of Breach............................................................120 19.9 No Intellectual Property Rights Granted.....................................120 19.10 Recording...................................................................120 19.11 Headings; Interpretation....................................................121 19.12 Expenses....................................................................121 19.13 Further Actions.............................................................121 19.14 Official Language...........................................................121 19.15 Entire Agreement; Tax Agreement.............................................121
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. xii. 14 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. EXHIBIT 10.25 COLLABORATION AGREEMENT This COLLABORATION AGREEMENT (the "Agreement") is executed by the Parties as of October 23, 1998 to become effective on the Effective Date (as defined in Section 19.1) hereof, by and between COULTER PHARMACEUTICAL, INC., a company incorporated under the laws of the State of Delaware, with its principal place of business at 550 California Avenue, Suite 200, Palo Alto, California 94306, USA ("Coulter"), and SMITHKLINE BEECHAM CORPORATION, a company incorporated under the laws of the Commonwealth of Pennsylvania, with its principal place of business at One Franklin Plaza, Philadelphia, Pennsylvania 19101, USA ("SB"). Both Coulter and SB are referred to individually as a "Party" and collectively as the "Parties." WHEREAS, Coulter has rights to and is developing that certain compound known as BEXXAR(TM) (as such term is defined below); and WHEREAS, SB would like to obtain the worldwide rights (except for Japan) to develop and commercialize BEXXAR and other PRODUCTS in the FIELD (as such terms are defined below); and WHEREAS, Coulter and SB wish to jointly commercialize BEXXAR and other PRODUCTS in the United States of America (excluding its territories, possessions and the Commonwealth of Puerto Rico); and WHEREAS, simultaneous with the execution of this Agreement, the Parties are entering into the LOAN AGREEMENT (as such term is defined below) and the STOCK PURCHASE AGREEMENT (as such term is defined below); NOW THEREFORE, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the Parties agree as follows: ARTICLE 1 DEFINITIONS For the purposes of this Agreement, the terms hereunder shall have the meanings as defined below: 1.1 "004 TRIAL" shall mean Coulter's clinical trial with Protocol No. RIT-II-004 ("Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy-Refractory Low-Grade B-Cell Lymphomas and Low- 1. 15 Grade Lymphomas That Have Transformed to Higher Grade Histologies") for which enrollment and interim analysis was completed prior to the Effective Date. 1.2 "ADDITIONAL INDICATIONS" shall mean any indications in the FIELD, other than the MAJOR INDICATIONS. 1.3 "AFFILIATE(S)" shall mean, in the case of either Coulter or SB, any corporation, joint venture, or other business entity which directly or indirectly controls, is controlled by, or is under common control with that Party. "Control," as used in this Section 1.3 only, shall mean having the power to direct, or cause the direction of, the management and policies of an entity, whether through ownership of voting securities, by contract or otherwise. 1.4 "ANTI-CD20 ANTIBODY" shall mean: (i) the B1 MURINE ANTIBODY or any derivative of the B1 MURINE ANTIBODY, including without limitation, any genetically engineered construct of the B1 MURINE ANTIBODY; (ii) any other anti-CD20 monoclonal antibody other than the B1 MURINE ANTIBODY including, without limitation, human, humanized, primatized, or chimerized antibody; (iii) any [*] of (i) or (ii); (iv) any [*] of (i) or (ii); (v) any [*] of (i) or (ii); (vi) any [*] of (i) or (ii); (vii) any [*] (i) or (ii); and (viii) any [*]. 1.5 "B1 MURINE ANTIBODY" shall mean the unconjugated IgG2a anti-CD20 murine monoclonal antibody which is one of the active agents tested in the 004 TRIAL. 1.6 "BEXXAR" shall mean B1 MURINE ANTIBODY conjugated with 131Iodine or unconjugated, depending upon context. 1.7 "BLA" shall mean a Biologics License Application, as defined by the regulations promulgated under the United States FD&C ACT and PHS ACT and any supplements thereunder, as amended from time to time. 1.8 "COMMERCIALLY REASONABLE EFFORTS" shall mean efforts and resources normally used by a Party for a compound owned by it or to which it has rights, which is of similar market [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 2. 16 potential at a similar stage in its product life, taking into account the [*], the [*] of [*], the [*], the [*], and other relevant factors including, [*] or [*]. 1.9 "CONTROL" shall mean, except as otherwise provided in Section 1.3, licensed or otherwise having rights to use, with the right to grant sublicenses, as provided in this Agreement without violating the terms of any THIRD PARTY agreement. 1.10 "CO-PROMOTION" shall mean the promotion, marketing and selling of the PRODUCT, including, without limitation, the detailing of the PRODUCT to physicians, jointly through the sales forces of Coulter and SB in TERRITORY A under the TRADEMARK and REGULATORY APPROVAL held by Coulter. 1.11 "COST OF GOODS" shall mean the cost of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY (in any form) sold and included in NET SALES or used in DEVELOPMENT or MANUFACTURE DEVELOPMENT and shall be computed in accordance with United States generally accepted accounting principles. COST OF GOODS shall include, without limitation, but subject to Section 8.1: (a) (i) in the case of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY acquired from THIRD PARTIES, payments made by either Party to such THIRD PARTIES in respect of such materials, including, but not limited to, [*] the UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY, [*] payments, [*] payments and [*] owed to such THIRD PARTIES, or (ii) in the case of UNCONJUGATED ANTIBODY manufactured by SB pursuant to an SB Supply Agreement (as defined in Section 9.6.1) which is entered into by the Parties pursuant to Section 9.6.1, the amounts set forth on the [*] attached to such SB Supply Agreement, or (iii) in the case of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY manufactured by Coulter pursuant to a Coulter Supply Agreement (as defined in Section 9.6.2) which is entered into by the Parties pursuant to Section 9.6.2, the amounts set forth on the [*] attached to such Coulter Supply Agreement, plus (b) QA/QC COSTS, plus (c) EXISTING THIRD PARTY LICENSE COSTS and NEW THIRD PARTY LICENSE COSTS, plus (d) the cost of forward foreign currency contracts to protect against risk of changes in foreign exchange rates, provided that such costs are approved in advance by the Parties, plus (e) the OUT-OF-POCKET COST of freight and tariffs associated with transporting UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY from the source of manufacture to the end [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 3. 17 user, inclusive of interim points of delivery, but excluding (i) any such costs which are separately invoiced to a customer, [*] involved in the [*]. COST OF GOODS shall exclude [*], which shall be separately borne by the Parties. COST OF GOODS shall also exclude [*] and [*], although [*] incurred in TERRITORY A shall be included as an element of the JOINT P&L. Subject to Section 1.58, [*] incurred outside of TERRITORY A shall be borne solely by [*]. In the event SB acquires UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY for TERRITORY A from a THIRD PARTY [*] has [*] of at [*], and if [*] has a reasonable good faith belief that [*] in the [*] THIRD PARTY, then [*] shall [*], and the Parties shall promptly meet to discuss the situation in good faith to determine whether or not [*] for [*] from the [*] to be agreed between the Parties [*], if any, in the [*] THIRD PARTY. In the event Coulter acquires UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY for TERRITORY A from a THIRD PARTY [*] has [*] of at [*], and if [*] has a reasonable good faith belief that [*] in the [*] THIRD PARTY, then [*], and the Parties shall promptly meet to discuss the situation in good faith to determine whether or not [*] for [*] from the [*] to be agreed between the Parties [*], if any, in the [*] THIRD PARTY. 1.12 "COULTER PATENT RIGHTS" shall mean all PATENT RIGHTS owned or CONTROLLED by Coulter as of the Effective Date or during the term of this Agreement. A list of the COULTER PATENT RIGHTS existing as of the date of mutual execution of this Agreement is set out in Exhibit A hereto and will be updated by Coulter on a semi-annual basis. 1.13 "CROSS-TERRITORY TRIALS" shall have the meaning set forth in Section 3.2.3. 1.14 "DEVELOPMENT" shall mean the following activities related to LICENSED COMPOUNDS or PRODUCTS within the FIELD performed in accordance with [*] JOINT DEVELOPMENT PLAN or [*] and [*] the [*] JOINT DEVELOPMENT PLAN and related to PLANNED CLINICAL TRIALS: (i) the pre-clinical development of a LICENSED COMPOUND for use in the FIELD; (ii) the clinical development of a PRODUCT for use in the FIELD through and including REGULATORY APPROVAL; (iii) regulatory activities associated with seeking REGULATORY APPROVALS of PRODUCT; and (iv) any post-REGULATORY APPROVAL clinical studies for label expansion or publication purposes or required by regulatory authorities for the PRODUCT for use in the FIELD, including Phase IV clinical studies. "DEVELOPMENT" shall not include any activities included in the definition of "MANUFACTURE DEVELOPMENT". 1.15 "DEVELOPMENT COSTS" shall mean, subject to Section 8.1, the following costs, to the extent incurred by a Party (i) in accordance with [*] JOINT DEVELOPMENT PLAN, or (ii) reasonably incurred by a Party [*] and [*] the [*] of such a plan, provided that any such DEVELOPMENT COSTS [*] a PLANNED CLINICAL TRIAL or [*] a PLANNED CLINICAL TRIAL shall be approved in advance by the co-chairpersons of the JDC: (a) all OUT-OF-POCKET COSTS charged to the DEVELOPMENT of any LICENSED COMPOUND or PRODUCT for use in the FIELD [*], including, but not limited to, [*]; plus [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 4. 18 (b) an appropriate allowance of FTES as required to support the activities outlined in Section 1.15(a), excluding, however, REGULATORY PERSONNEL; plus (c) COST OF GOODS for DEVELOPMENT incurred under Section 9.7. 1.16 "DISTRIBUTION COSTS" shall have the meaning set forth at Section B.3.2 on Exhibit B-1. 1.17 "EUROPE" shall mean all countries and territories set forth on Exhibit C. 1.18 "EUROPEAN FACILITY" shall have the meaning set forth in Section 9.10.1. 1.19 "EXISTING THIRD PARTY LICENSE" shall mean any of the following agreements: (i) Agreement between Sidney Farber Cancer Institute and Coulter Electronics, Inc., dated July 23, 1981. (ii) Modification Agreement between Dana-Farber Cancer Institute and Coulter Electronics, Inc., dated March 1, 1983. (iii) License Agreement between Dana-Farber Cancer Institute and Coulter Immunology, Division of Coulter Corporation, dated April 28, 1983. (iv) Modification Agreement No. 2 between Dana-Farber Cancer Institute and Coulter Immunology, Division of Coulter Corporation, dated April 1, 1987. (v) Agreement between Coulter Corporation and Dana-Farber Cancer Institute, Inc., dated April 1, 1994. (vi) Assignment Agreement among Coulter Pharmaceutical, Inc., Coulter Corporation, InterWest Partners V, L.P. and InterWest Investors V, dated February 24, 1995. (vii) Commercialization Agreement between Coulter Corporation and the Regents of the University of Michigan, dated November 1, 1994. (viii) Amendment to Commercialization Agreement between Coulter and the Regents of the University of Michigan, dated June 1, 1997. (ix) Any amendment to (i) through (viii) executed by Coulter prior to the Effective Date (as defined in Section 19.1) and disclosed to SB prior to SB's acceptance or waiver of the conditions to effectiveness set forth in Section 19.1. Coulter agrees to provide SB with an update of this Section 1.19 as of the Effective Date (as defined in Section 19.1). [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 5. 19 1.20 "EXISTING THIRD PARTY LICENSE COSTS" shall mean any amounts to be paid by Coulter to a THIRD PARTY licensor under any EXISTING THIRD PARTY LICENSE, to the extent such amounts (i) relate to LICENSED COMPOUND or PRODUCT, and (ii) become payable after the Effective Date; provided, however, EXISTING THIRD PARTY LICENSE COSTS shall exclude [*] and [*] which are [*] (which [*] and [*] shall be [*] (a) in the event [*] the [*] of the [*] (or the [*] does [*] a [*] of such [*,] or (b) in the event that [*] does [*] a [*] of [*]. 1.21 "FD&C ACT" shall mean the United States Federal Food, Drug and Cosmetic Act, as amended. 1.22 "FDA" shall mean the United States Food and Drug Administration or its successor. 1.23 "FIELD" shall mean the treatment, prevention or palliation of any indication in humans. [*] shall [*] of [*]. 1.24 "FINANCE SUBTEAM" shall have the meaning set forth in Section 2.4. 1.25 "FIRST COMMERCIAL SALE" shall mean the first commercial sale of a PRODUCT in a given jurisdiction after the PRODUCT has been granted REGULATORY APPROVAL by the competent authorities in such jurisdiction. 1.26 "FIRST INDICATION" shall mean the label claim(s) which are approved in the first REGULATORY APPROVAL for BEXXAR in a given jurisdiction, provided that such claims are for a MAJOR INDICATION. 1.27 "FORCE MAJEURE OCCURRENCE" shall have the meaning set forth in Article 12. 1.28 "FTE" shall mean a full-time equivalent professional employee of a Party, other than a clerical, administrative assistant, or secretarial employee, for whom reimbursement is to be paid under this Agreement at the applicable rates set forth on Exhibit B-2. By way of example, (i) if an employee is a full-time employee and spends one hundred percent (100%) of his or her time on activities for which reimbursement is to be paid under this Agreement, such employee shall count as one (1) FTE, and (ii) if an employee is a full-time employee and spends forty percent (40%) of his or her time on activities for which reimbursement is to be paid under this Agreement, such employee shall count as four-tenths (0.4) of an FTE. 1.29 "GOOD CLINICAL PRACTICE" or "GCP" shall mean the then current standards for clinical trials for pharmaceuticals, as set forth in (i) the FD&C ACT and applicable regulations and guidances promulgated thereunder, including without limitation the Code of Federal Regulations, as amended from time to time and, as applicable, (ii) the rules and regulations of the International Conference on Harmonization, and (iii) any other applicable requirements for clinical trial activities under the laws, rules or regulations of TERRITORY A and the other countries of the TERRITORY. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 6. 20 1.30 "GOOD LABORATORY PRACTICE" or "GLP" shall mean the then current standards for laboratory activities for pharmaceuticals, as set forth in the FD&C ACT and applicable regulations and guidances promulgated thereunder, including without limitation the Code of Federal Regulations, as amended from time to time, and subject to Section 9.14.2, any other applicable requirements for laboratory activities under the laws, rules or regulations of TERRITORY A and the other countries of the TERRITORY. 1.31 "GOOD MANUFACTURING PRACTICE" or "GMP" shall mean the current standards for the manufacture of pharmaceuticals, as set forth in the FD&C ACT and applicable regulations and guidances promulgated thereunder, including without limitation the Code of Federal Regulations, as amended from time to time, and subject to Section 9.14.2, any other applicable manufacturing requirements under the laws, rules or regulations of TERRITORY A, such as the Nuclear Regulatory Commission Guidelines, and the other countries of the TERRITORY. 1.32 "GUARANTEED COGS PLUS ROYALTIES PERCENT" shall have the meaning set forth in Section 7.2.5(c). 1.33 "GUARANTEED COGS TERRITORY" shall mean [*], as may be expanded in accordance with Section 7.2.5(g). 1.34 "INTELLECTUAL PROPERTY RIGHTS" shall mean all PATENT RIGHTS, copyrights, regulatory filings, KNOW-HOW and/or trade secrets, or any other intellectual property other than trademarks, which are owned or CONTROLLED as of the Effective Date or during the term of this Agreement by one Party hereto or jointly by the Parties, with regard to the DEVELOPMENT, manufacture, importing, use, marketing and/or sale of the PRODUCT. INTELLECTUAL PROPERTY RIGHTS shall include any rights obtained by either Party from a THIRD PARTY license pursuant to Section 5.3, subject to the terms and conditions of such license. The term "INTELLECTUAL PROPERTY RIGHTS," however, shall not include PATENT RIGHTS, copyrights, regulatory filings, KNOW-HOW and/or trade secrets, or any other intellectual property of [*] for the [*] whether developed prior to or after the Effective Date. 1.35 "INVENTION" shall mean an invention conceived or reduced to practice in the course of or as a result of the performance of this Agreement by an employee or agent of a Party. The term "INVENTION" however, shall not include an invention conceived or reduced to practice in the course of or as a result of the performance of this Agreement by an employee or agent of SB, other than jointly with an employee or agent of Coulter, for the [*]. 1.36 "JOINT COMMERCIALIZATION COMMITTEE" or "JCC" shall mean the committee appointed by the Parties as set forth in Section 2.2. 1.37 "JOINT DEVELOPMENT COMMITTEE" or "JDC" shall mean the committee appointed by the Parties as set forth in Section 2.1. 1.38 "JOINT DEVELOPMENT PLAN" shall be the then current plan and budget which is described in Section 3.2.1 and approved in accordance with Section 3.2.1(c). The PLANNED [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 7. 21 CLINICAL TRIALS as of the Effective Date, which will be a part of the JOINT DEVELOPMENT PLAN for BEXXAR, are attached hereto as Exhibit D. 1.39 "JOINT MANUFACTURE DEVELOPMENT PLAN" shall mean the then current plan and budget which is described in Section 3.3.1 and approved in accordance with Section 3.3.1(c). 1.40 "JOINT MARKETING PLAN" shall mean the then current plan and budget which is described in Section 7.1.3 and approved in accordance therewith. 1.41 "JOINT P&L" shall have the meaning set forth in Section 7.1.14. 1.42 "KNOW-HOW" shall mean all know-how, including DEVELOPMENT, MANUFACTURE DEVELOPMENT and commercialization data, processes and information, including any copyright relating thereto, owned or CONTROLLED by either Party as of the Effective Date or acquired during the term of this Agreement relating to: (a) ANTI-CD20 ANTIBODY, including any LICENSED COMPOUND or PRODUCT; (b) any component of (a); (c) any intermediate in the making of any of (a) or (b); (d) methods of making any of (a), (b) or (c); (e) any method of using any of (a), (b), or (c); (f) any use of (a); (g) any formulation or delivery system for (a); and/or (h) any other data related to the development, manufacture, marketing or sale of (a). The term "KNOW-HOW," however, shall not include (i) any know-how, processes, information and data which is, as of the Effective Date or becomes later on, available to the public except by fault of the receiving Party, or (ii) proprietary know-how of [*] for the [*] whether developed prior to or after the Effective Date. 1.43 "LICENSED COMPOUND" shall mean BEXXAR and any SECOND GENERATION LICENSED COMPOUNDS. 1.44 "LOAN AND SECURITY AGREEMENTS" shall mean the loan and security agreements between the Parties described in Section 6.1.2(b). 1.45 "MAA" shall mean that regulatory application in the European Community which is the equivalent of a BLA. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 8. 22 1.46 "MAJOR INDICATIONS" shall mean the following indications within the FIELD: (a) [*]; (b) [*]; (c) [*]; (d) [*]; (e) [*]; (f) [*]; and (g) [*]. The MAJOR INDICATIONS set forth in (a)-(f) hereof may be treated [*]. 1.47 "MAJOR MARKET COUNTRY" shall mean [*]. 1.48 "MAJOR MARKETS IN TERRITORY C" shall have the meaning set forth in Section 6.2.1(d). 1.49 "MANUFACTURE AND SUPPLY CHAIN SUBTEAM" shall mean the subteam appointed by the Parties as set forth in Section 2.3. 1.50 "MANUFACTURE DEVELOPMENT" shall mean the following activities related to LICENSED COMPOUNDS or PRODUCTS within the FIELD performed in accordance with the then current JOINT MANUFACTURE DEVELOPMENT PLAN: (i) PRODUCT improvement activities, such as reformulation, whether occurring before or after REGULATORY APPROVAL; (ii) the development of manufacturing processes for the UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY; including without limitation, process development and optimization, manufacturing scale-up, validation, qualification, and certification; (iii) the [*] or [*] of [*] or equipment for the manufacture of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY; and (iv) any [*] associated with (i), (ii), and (iii) above. "MANUFACTURE DEVELOPMENT" shall not include any activities included in the definition of "DEVELOPMENT". 1.51 "MANUFACTURE DEVELOPMENT COSTS" shall mean, subject to Section 8.1: (i) the following costs to the extent incurred by a Party [*] and [*] of [*] JOINT MANUFACTURE DEVELOPMENT PLAN: OUT-OF-POCKET COSTS (plus FTE costs to the extent described in the last sentence of this subsection (i)) reasonably incurred by a Party [*] the [*] and directly related to: (a) BLA preparation at the [*] manufacturing site, (b) scale-up and BLA preparation at the [*] manufacturing site, [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 9. 23 (c) qualification of the [*] at the [*] site, and (d) [*] at [*], provided that any particular MANUFACTURE DEVELOPMENT COSTS incurred under this subsection (i) (a) shall be in accordance with the forecast provided to SB in the [*] (b) any individual amount for a specific program or activity is not in excess of [*] and (c) the total OUT-OF-POCKET COSTS prior to the adoption of such JOINT MANUFACTURE DEVELOPMENT PLAN shall not [*] unless such amount has received the prior written approval of the co-chairpersons of the JDC within ten (10) business days of presentation to such co-chairpersons of a statement describing and requesting such expenditures. To the extent there are FTE costs, excluding REGULATORY PERSONNEL, reasonably incurred by a Party [*] to the [*] JOINT MANUFACTURE DEVELOPMENT PLAN in direct support of the activities mentioned under this subsection (i), such FTE costs shall be [*] to [*] based upon [*] upon the necessary FTEs required to perform such work under the initial JOINT MANUFACTURE DEVELOPMENT PLAN; and (ii) the following costs to the extent incurred in accordance with [*] JOINT MANUFACTURE DEVELOPMENT PLAN: (a) all OUT-OF-POCKET COSTS charged to the MANUFACTURE DEVELOPMENT of any LICENSED COMPOUND or PRODUCT for use in the FIELD [*]; plus (b) an appropriate allowance of FTES as required to support the activities outlined in Section 1.51(ii)(a), excluding, however, REGULATORY PERSONNEL. To the extent [*] are included within MANUFACTURE DEVELOPMENT COSTS, such [*] shall be allocated in the manner provided in Section 3.3.3. 1.52 "MARKETING COSTS" shall have the meaning set forth on Exhibit B-1, subject to Section 8.1, to the extent incurred [*] and (i) in accordance with the then current JOINT MARKETING PLAN, or (ii) reasonably incurred by a Party prior to the adoption of such a plan, provided, however, that, under this clause (ii), any individual amount for a specific program or activity shall not exceed [*] and the total amounts spent prior to the adoption of such JOINT MARKETING PLAN shall not exceed [*], each without the prior written approval of the co-chairpersons of the JCC within ten (10) business days of presentation of a statement to such co-chairpersons describing and requesting such expenditures. 1.53 "[*]" shall mean a [*] filed with the [*]. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 10. 24 1.54 "NET SALES" shall mean gross amounts invoiced for sales of the PRODUCT in the FIELD in the relevant TERRITORY by either Party, its AFFILIATES or sublicensees, as appropriate, to THIRD PARTIES, less the following items: (i) trade, quantity and cash discounts or rebates actually allowed and taken and any other adjustments, including, without limitation, those granted on account of price adjustments, billing errors, rejected goods, damaged goods and recall returns; (ii) credits, rebates, charge-back and prime vendor rebates, fees, reimbursements or similar payments granted or given to wholesalers and other distributors, buying groups, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations or other institutions or health care organizations; (iii) any tax, tariff, customs duties, excise or other duties or other governmental charge (other than an income tax) levied on the sale, transportation or delivery of a PRODUCT and borne by the seller thereof; (iv) payments or rebates paid in connection with sales of PRODUCTS to any governmental or regulatory authority in respect of any state or federal Medicare, Medicaid or similar programs; (v) any charge for freight, insurance or other transportation costs charged to the customer; and (vi) any write-offs for bad debt. Sales of PRODUCT by and between a Party and its AFFILIATES are not sales to THIRD PARTIES (except where such AFFILIATES are end users) and shall be excluded from NET SALES calculations for all purposes. Notwithstanding the immediately preceding sentence, it is understood that any transactions between SB or any of its AFFILIATES or any of its or their sublicensees on the one hand and [*] on the other hand will be deemed to be transactions with THIRD PARTIES for the purposes of computing NET SALES, provided that the conditions of such sales to [*], including any and all rebates and discounts allocated to transactions with any such [*], shall be on an arms length basis and shall be fully deductible for such computation purposes. In the event that any [*] type activity is within SB or within any of its AFFILIATES or its or their sublicensees as only part of its or their total activities rather than in a separate AFFILIATE, a notional NET SALES figure will be calculated on an arms length basis to cover such activities. [*] or [*] or [*] a [*] for or [*] including [*]. As of the Effective Date, an [*] the [*] of [*], a [*] of [*] and [*] of [*]. 1.55 "NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS" shall have the meaning set forth in Section 9.3. 1.56 "NEW THIRD PARTY LICENSE" shall have the meaning set forth in Section 5.3.2. 1.57 "NEW THIRD PARTY LICENSE COSTS" shall have the meaning set forth in Section 5.3.3(d). 1.58 "NON-USA COGS" shall mean, for each country in the GUARANTEED COGS TERRITORY: (a) the COST OF GOODS for such country, plus (b) SB's OUT-OF-POCKET COSTS of distributing PRODUCT in such country not already included in Section 1.58(a); plus (c) SB's OUT-OF-POCKET COST of [*] or [*] in [*]. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 11. 25 NON-USA COGS shall exclude any UNCONJUGATED ANTIBODY [*] provided that at the time of shipping of such UNCONJUGATED ANTIBODY by Coulter or the THIRD PARTY manufacturer to SB there is expiration dating approved by the relevant regulatory authority remaining of not less than [*] for such UNCONJUGATED ANTIBODY in [*], such expiration dating to be extended, as approved by the relevant regulatory authorities, up to a maximum of [*] as real time data becomes available. 1.59 "NON-USA MARKETING PLAN" shall mean that marketing plan which relates to the commercialization of PRODUCT in the NON-USA TERRITORY as produced by SB in accordance with SB's standard internal procedures. 1.60 "NON-USA TERRITORY" shall mean TERRITORY B and TERRITORY C. 1.61 "NORTH AMERICA" shall mean [*] TERRITORY A; [*]. 1.62 "OPERATING PROFIT OR LOSS" shall have the meaning set forth on Exhibit B-1. 1.63 "OTHER OPERATING INCOME/EXPENSE" shall have the meaning set forth on Exhibit B-1. 1.64 "OUT-OF-POCKET COSTS" shall mean any out-of-pocket payment made by a Party to a THIRD PARTY who is not an AFFILIATE of such Party but only to the extent such payment relates to costs which are incurred by a Party [*] with respect to DEVELOPMENT COSTS, MANUFACTURE DEVELOPMENT COSTS, or MARKETING COSTS, or after the Effective Date with respect to all other out-of-pocket payments. 1.65 "PATENT COSTS" shall mean the OUT-OF-POCKET COSTS incurred after the Effective Date in connection with the filing, prosecution and maintenance of PATENT RIGHTS, as well as the costs of any patent interference, reexamination, reissue, opposition and revocation proceedings in connection with PATENT RIGHTS. PATENT COSTS shall also include those costs incurred by a Party under Sections 11.4 or 11.5 with respect to TERRITORY A. 1.66 "PATENT RIGHTS" shall mean all patents or patent applications, throughout the relevant TERRITORY and all divisionals, continuations, continuations-in-part, reissues, extensions, supplementary protection certificates thereof, owned or CONTROLLED by a Party or the Parties and existing as of the Effective Date or filed or issuing during the term of this Agreement, at least one claim of which covers: (a) an ANTI-CD20 ANTIBODY, including any LICENSED COMPOUND or PRODUCT; (b) any component of (a); (c) any intermediate in the making of any of (a) or (b); (d) methods of making any of (a), (b) or (c); [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 12. 26 (e) any method of using any of (a), (b), or (c); (f) any use of (a); (g) any formulation or delivery system for (a); and/or (h) any other subject matter related to the development, manufacture, formulation, use or sale of (a). The term "PATENT RIGHTS" however shall not include [*] to the extent that they cover [*] including, without limitation, [*] as a result of [*], other than [*], related to [*]. 1.67 "PHS ACT" shall mean the United States Public Health Service Act, as amended. 1.68 "PLANNED CLINICAL TRIALS" shall mean those clinical trials of BEXXAR which as of the Effective Date the Parties intend to complete or undertake as part of the Development. A list and description of the PLANNED CLINICAL TRIALS, as of the Effective Date, is attached hereto as Exhibit D. The actual clinical trial program for PRODUCTS and budget therefor shall be defined by the JOINT DEVELOPMENT COMMITTEE pursuant to the JOINT DEVELOPMENT PLAN adopted from time to time in accordance with Section 3.2.1. 1.69 "PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS" shall have the meaning set forth in Section 9.2. 1.70 "PRODUCT" shall mean any pharmaceutical PRODUCT containing a LICENSED COMPOUND in any formulation or mode of administration. 1.71 "QA/QC COSTS" shall mean, subject to Section 8.1, OUT-OF-POCKET COSTS and FTE costs of quality assurance and quality control work performed by the Parties related to PRODUCT release and PRODUCT testing of the UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY determined in accordance with this Section 1.71, but only to the extent that such quality assurance and quality control work is required by the FDA or other relevant regulatory authorities. QA/QC COSTS shall include a reasonable allocation of Coulter's facility overhead, but shall exclude [*] or any [*]. QA/QC COSTS shall be calculated on the basis of a cost per batch to be mutually agreed by the Parties to approximate the actual cost of such work. In any event, QA/QC COSTS shall not exceed [*] of UNCONJUGATED ANTIBODY [*] of RADIOLABELED ANTIBODY. 1.72 "RADIOLABELED ANTIBODY" shall mean (i) the B1 MURINE ANTIBODY conjugated to (131)Iodine [*] or (ii) any SECOND GENERATION ANTIBODY conjugated to (131)Iodine [*], in each case in finished pharmaceutical form, packaged for use by the end user (or for delivery to a radiopharmacy, as the case may be). 1.73 "REGULATORY APPROVAL" shall mean all authorizations by governmental authorities which are required for the marketing, promotion, pricing and sale of the PRODUCT in a given country or regulatory jurisdiction, including all manufacturing, pricing and reimbursement [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 13. 27 approvals. If the PRODUCT is being sold commercially in a country (other than under a treatment Investigational New Drug application, compassionate use program or foreign equivalent) by a Party, REGULATORY APPROVAL shall be deemed to have occurred in any event. 1.74 "REGULATORY PERSONNEL" shall mean any individual that is primarily involved in the preparation, filing or maintenance of a regulatory filing or maintenance of a REGULATORY APPROVAL or any aspect of adverse event reporting, with respect to a LICENSED COMPOUND or PRODUCT. 1.75 "SALES COSTS" shall have the meaning set forth on Exhibit B-1. 1.76 "SALES EFFORT" shall have the meaning set forth in Section 7.1.6(a). 1.77 "SB OPTION EXERCISE NOTICE" shall have the meaning set forth in Section 4.2.2(a). 1.78 "SB PATENT RIGHTS" shall mean all PATENT RIGHTS owned or CONTROLLED by SB during the term of this Agreement. [*] of the [*]. As such SB PATENT RIGHTS [*], they will be added to Exhibit E as such exhibit is updated, which update shall be on a semi-annual basis. 1.79 "SECOND GENERATION ANTIBODY" shall mean the antibody component of a SECOND GENERATION LICENSED COMPOUND. 1.80 "SECOND GENERATION ANTIBODY CANDIDATE" shall mean: (i) any derivative of the B1 MURINE ANTIBODY, including without limitation, any genetically engineered construct of the B1 MURINE ANTIBODY; (ii) any other anti-CD20 monoclonal antibody other than the B1 MURINE ANTIBODY including, without limitation, human, humanized, primatized, or chimerized antibody; (iii) any [*] of (i) or (ii); (iv) any [*] of (i) or (ii); (v) any [*] of (i) or (ii); (vi) any [*] of (i) or (ii); (vii) any [*] of (i) or (ii); or (viii) any [*]. 1.81 "SECOND GENERATION LICENSED COMPOUND" shall mean a SECOND GENERATION LICENSED COMPOUND CANDIDATE (i) for which SB has provided an SB OPTION EXERCISE NOTICE [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 14. 28 pursuant to Section 4.2.2(a) or (ii) which has become a SECOND GENERATION LICENSED COMPOUND in accordance with Section 4.2.4(a)-(b). 1.82 "SECOND GENERATION LICENSED COMPOUND CANDIDATE" shall mean (i) an unconjugated SECOND GENERATION ANTIBODY CANDIDATE; (ii) B1 MURINE ANTIBODY conjugated to [*] (iii) a SECOND GENERATION ANTIBODY CANDIDATE conjugated to [*]; or (iv) a SECOND GENERATION ANTIBODY CANDIDATE conjugated to [*]. 1.83 "SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS" shall mean, subject to Section 8.1, the following costs incurred by a Party after the Effective Date and prior to the date on which a given SECOND GENERATION LICENSED COMPOUND CANDIDATE becomes a SECOND GENERATION LICENSED COMPOUND (pursuant to Section 4.2.2(a), 4.2.4(a) or 4.2.4(b), as applicable): (a) all OUT-OF-POCKET COSTS reasonably charged to the pre-clinical and clinical development of a SECOND GENERATION LICENSED COMPOUND CANDIDATE for use in the FIELD, including, but not limited to, [*] (b) an appropriate allowance of FTES as required to support the activities outlined in Section 1.83(a), excluding, however, REGULATORY PERSONNEL; plus (c) COST OF GOODS of such SECOND GENERATION LICENSED COMPOUND CANDIDATE for such pre-clinical and clinical development. To the extent practical, SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS shall be calculated in the same manner as DEVELOPMENT COSTS; provided, however, that there shall be no requirement that SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS be incurred under a mutually-agreed plan. 1.84 "SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS" shall mean, subject to Section 8.1, the following costs incurred by a Party after the Effective Date and prior to the date on which a given SECOND GENERATION LICENSED COMPOUND CANDIDATE becomes a SECOND GENERATION LICENSED COMPOUND (pursuant to Section 4.2.2, 4.2.4(a) or 4.2.4(b), as applicable): (a) all OUT-OF-POCKET COSTS reasonably charged to the development of manufacturing processes for a SECOND GENERATION LICENSED COMPOUND CANDIDATE for use in the FIELD, including without limitation, [*] and [*]; plus (b) an appropriate allowance of FTES as required to support the activities outlined in Section 1.84(a), excluding, however, REGULATORY PERSONNEL. To the extent practical, SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS shall be calculated in the same manner as MANUFACTURE DEVELOPMENT COSTS; provided, however, that there shall be no requirement that SECOND [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 15. 29 GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS be incurred under a mutually-agreed plan. 1.85 "SECOND INDICATION" shall mean label claim(s), other than FIRST INDICATION label claim(s), which are approved in a REGULATORY APPROVAL received for BEXXAR in a given jurisdiction subsequent to the REGULATORY APPROVAL for the FIRST INDICATION, provided that such claims are for a MAJOR INDICATION. 1.86 "STOCK PURCHASE AGREEMENT" shall mean that agreement between the Parties described in Section 6.1.2(a). 1.87 "TERM OF CO-PROMOTION" shall mean, with respect to each PRODUCT, the period extending from FIRST COMMERCIAL SALE of such PRODUCT in TERRITORY A until termination or expiration of this Agreement in accordance with the provisions hereof or termination of CO-PROMOTION of such PRODUCT pursuant to Section 7.1.15. 1.88 "TERRITORY" shall mean all countries and territories of the world except for Japan (i.e., the sum of TERRITORY A, TERRITORY B and TERRITORY C). 1.89 "TERRITORY A" shall mean [*]. 1.90 "TERRITORY B" shall mean [*]. 1.91 "TERRITORY C" shall mean [*]. 1.92 "THIRD INDICATION" shall mean label claim(s), other than FIRST INDICATION label claim(s) and SECOND INDICATION label claim(s), which are approved in a REGULATORY APPROVAL received for BEXXAR in a given jurisdiction subsequent to the REGULATORY APPROVAL for the FIRST INDICATION and the REGULATORY APPROVAL for the SECOND INDICATION, provided that such claims are for a MAJOR INDICATION. 1.93 "THIRD PARTY(IES)" shall mean any person(s) or entity(ies) other than Coulter, SB or their respective AFFILIATES for so long as they remain AFFILIATES. 1.94 "TRADEMARK" shall mean the trademark(s) under which the PRODUCT shall be marketed throughout the TERRITORY, as more fully described in Article 10, as well as logos and slogans. 1.95 "TRADEMARK COSTS" shall mean the fees and expenses paid to outside legal counsel and experts, and creation, search, prosecution, registration and maintenance expenses, incurred after the Effective Date, in connection with the registration and maintenance of TRADEMARKS. TRADEMARK COSTS shall also include costs incurred by a Party under Section 10.5. 1.96 "UNAFFILIATED EXPERT" shall mean an individual who (i) is not a current employee or director of, or consultant to, one of the Parties or of an entity which currently has a commercial alliance with one of the Parties, (ii) has disclosed any previous affiliation with one of [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 16. 30 the Parties of the type described in clause (i) of this Section 1.96, (iii) is mutually acceptable to the Parties, and (iv) has suitable expertise on the topic in question. 1.97 "UNCONJUGATED ANTIBODY" shall mean the unconjugated B1 MURINE ANTIBODY and any unconjugated SECOND GENERATION ANTIBODY. Except as otherwise specified in this Agreement, UNCONJUGATED ANTIBODY shall mean both bulk and filled material. ARTICLE 2 MANAGEMENT OF COLLABORATION 2.1 JOINT DEVELOPMENT COMMITTEE (JDC). 2.1.1 FORMATION; MEMBERSHIP. Within thirty (30) days after the Effective Date, the Parties will establish a JOINT DEVELOPMENT COMMITTEE to oversee and coordinate DEVELOPMENT and MANUFACTURE DEVELOPMENT of the PRODUCT in the FIELD. The JDC shall be composed of [*] of representatives appointed by each of Coulter and SB. The JDC shall initially have [*] representatives of each Party, but the JDC may change its size from time to time by mutual consent of its members. In addition, the co-chairpersons of the JCC shall be members of the JDC. Each Party may replace its JDC representatives at any time upon written notice to the other Party. Each Party's representatives on the JDC shall be [*] of such Party with the authority to make decisions on behalf of such Party within the constraints of necessary internal approvals which will have been previously obtained and at least [*] of each Party's representatives will [*] or above for such Party. Each Party will name, from among its [*] representatives, a co-chairperson of the JDC. The co-chairpersons of the JDC shall be responsible for the administration of meetings (e.g., calling meetings, preparing and circulating an agenda in advance of each meeting, running the meetings and preparing and issuing written minutes of each meeting within thirty (30) days thereafter) but shall have no additional powers or rights other than those held by virtue of being a representative on the JDC. Minutes of the JDC meetings shall be promptly reviewed by both Parties, and shall be deemed approved when mutually accepted by the Parties as evidenced in writing. 2.1.2 DECISION-MAKING. Decisions of the JDC shall be by [*], with each Party having [*]. Should the members of the JDC [*] on an issue, then [*] to [*] the issue shall be [*] and the [*]. In the event that the [*] and the [*] are [*] on the issue, the Parties shall pursue a dispute resolution process pursuant to Section 18.3. 2.1.3 MEETINGS. The JDC shall meet at least one (1) time per calendar quarter during the term of this Agreement, unless otherwise mutually agreed by the Parties. Meetings of the JDC will be held at facilities alternately selected by Coulter and by SB. Meetings of the JDC may be held by video or audio conference with the consent of each Party. Meetings of the JDC shall be effective only if a representative of each Party is present or participating. Each Party shall promptly report to the JDC on all material issues relating to DEVELOPMENT and MANUFACTURE DEVELOPMENT. Each Party shall bear all expenses it incurs in regard to participating in such meetings of the JDC, including all travel and living expenses, and such [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 17. 31 expenses shall not be included in the calculation of the JOINT P&L, COST OF GOODS, DEVELOPMENT COSTS or MANUFACTURE DEVELOPMENT COSTS. 2.1.4 SPECIFIC RESPONSIBILITIES OF THE JDC. In addition to its general responsibility to oversee, monitor, review, coordinate and provide strategic direction to the DEVELOPMENT and MANUFACTURE DEVELOPMENT according to the JOINT DEVELOPMENT PLAN and the JOINT MANUFACTURE DEVELOPMENT PLAN and to ensure a regular flow of DEVELOPMENT and MANUFACTURE DEVELOPMENT information among the Parties, the JDC shall in particular: (i) develop, approve and monitor the JOINT DEVELOPMENT PLAN in accordance with Sections 3.2.1(b), (c) and (d); (ii) review, approve and monitor the JOINT MANUFACTURE DEVELOPMENT PLAN in accordance with Sections 3.3.1(b), (c) and (d); (iii) review, coordinate and approve [*], including, but not limited to, [*] and [*] conducted with respect to the PRODUCT in the FIELD throughout the TERRITORY (it being understood that, by entering into this Agreement, the Parties hereby approve the [*] as outlined on [*] as of such date, subject to subsequent changes in the [*] by the JOINT DEVELOPMENT COMMITTEE in accordance with Section 3.2.1); (iv) facilitate the flow of information between the Parties with respect to all DEVELOPMENT or MANUFACTURE DEVELOPMENT work being conducted in the FIELD anywhere in the TERRITORY; (v) oversee, with the MANUFACTURE AND SUPPLY CHAIN SUBTEAM, preparation of [*] of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY for DEVELOPMENT and MANUFACTURE DEVELOPMENT activities in accordance with Sections 9.12.1(a) and 9.12.2; (vi) consider whether the PRODUCT [*], as more fully discussed in [*], and when appropriate, approve [*] DEVELOPMENT and MANUFACTURE DEVELOPMENT and reflect in the JOINT DEVELOPMENT PLAN and JOINT MANUFACTURE DEVELOPMENT PLAN which [*] and which tasks associated with such [*] shall be performed by each Party; (vii) coordinate and approve strategy for all [*] to be made with respect to PRODUCT throughout the TERRITORY and approve [*] in TERRITORY A in accordance with Section 3.2; (viii) subject to clause (iii) above regarding [*] and Section 3.2.1(c), review and approve any decision to be made [*] with respect to DEVELOPMENT of the PRODUCT in the FIELD in the NON-USA TERRITORY which is reasonably likely to have [*] DEVELOPMENT or commercialization of the PRODUCT in the FIELD in TERRITORY A; (ix) oversee the MANUFACTURING AND SUPPLY CHAIN SUBTEAM, to the extent described in Section 2.3; [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 18. 32 (x) oversee the FINANCE SUBTEAM, to the extent described in Section 2.4; and (xi) perform any other responsibilities set forth for the JDC in this Agreement. 2.2 JOINT COMMERCIALIZATION COMMITTEE (JCC). 2.2.1 FORMATION; MEMBERSHIP. Within thirty (30) days after the Effective Date, the Parties will establish a JOINT COMMERCIALIZATION COMMITTEE to oversee and coordinate the commercialization of the PRODUCT in the FIELD in TERRITORY A and to perform those activities described in Section 2.2.4. The JCC shall be composed of [*] of representatives appointed by each of Coulter and SB. The JCC shall initially have [*] representatives of each Party, but the JCC may change its size from time to time by mutual consent of its members. In addition, the co-chairpersons of the JDC shall be members of the JCC. Each Party may replace its JCC representatives at any time upon written notice to the other Party. Each Party's representatives on the JCC shall be [*] of such Party with the authority to make decisions on behalf of such Party within the constraints of necessary internal approvals which will have been previously obtained and at [*] of each Party's representatives will [*] or above for such Party. Each Party will name, from among its [*] representatives, a co-chairperson of the JCC. The co-chairpersons shall be responsible for the administration of meetings (e.g., calling meetings, preparing and circulating an agenda in advance of each meeting, running the meetings and preparing and issuing written minutes of each meeting within thirty (30) days thereafter) but shall have no additional powers or rights other than those held by virtue of being a representative on the JCC; provided, however, the co-chairpersons shall be authorized, between meetings of the JCC, to make joint operational decisions as needed with respect to TERRITORY A, consistent with the approved JOINT MARKETING PLAN. Minutes of the JCC meetings shall be promptly reviewed and shall be deemed approved when mutually accepted by the Parties as evidenced in writing. 2.2.2 DECISION-MAKING. Decisions of the JCC shall be [*], with each Party having [*]. Should the members of the JCC [*] on an issue, then after [*] to [*] the issue shall be [*] and the [*]. In the event the [*] and the [*] are [*] on the issue, the Parties shall pursue a dispute resolution process pursuant to Section 18.3. 2.2.3 MEETINGS. The JCC shall meet at least one (1) time per calendar quarter during the term of this Agreement, unless otherwise mutually agreed by the Parties. It is anticipated that, during certain time periods (e.g., immediately before and immediately after commercial launch in TERRITORY A), the JCC will meet more frequently than once per calendar quarter. Meetings of the JCC will be held at facilities alternately selected by Coulter and by SB. Meetings of the JCC may be held by video or audio conference with the consent of each Party. Meetings of the JCC shall be effective only if a representative of each Party is present or participating. Each Party shall promptly report to the JCC on all material issues relating to the commercialization of PRODUCT. Each Party shall bear all expenses it incurs in regard to participating in such meetings of the JCC, including all travel and living expenses, and such [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 19. 33 expenses shall not be included in determining the JOINT P&L outlined in Paragraph 7.1.14 or COST OF GOODS, DEVELOPMENT COSTS, or MANUFACTURE DEVELOPMENT COSTS. 2.2.4 SPECIFIC RESPONSIBILITIES OF THE JCC. In addition to its general responsibility to oversee, monitor, review, coordinate and provide strategic direction to the commercialization of PRODUCT according to the JOINT MARKETING PLAN and to ensure a regular flow of commercialization information among the Parties, the JCC shall in particular: (i) oversee and coordinate the activities of the Parties in marketing, selling and distributing PRODUCT in TERRITORY A prior to and following REGULATORY APPROVAL in TERRITORY A, including [*] and determining the [*] of each Party in CO-PROMOTION of the PRODUCT, consistent with Article 7; (ii) develop and approve the first JOINT MARKETING PLAN (which shall [*] the [*] the [*] REGULATORY APPROVAL in TERRITORY A) in accordance with Section 7.1.3(b), it being understood that such JOINT MARKETING PLAN shall include at least the [*] described in Section 9.12; (iii) develop and approve each subsequent JOINT MARKETING Plan, in accordance with Section 7.1.3(b), the timing and structure of such plan [*] for such development and approval, provided that such must occur no less than [*]; (iv) monitor compliance with the JOINT MARKETING PLAN and approve any changes to the JOINT MARKETING PLAN, in accordance with Section 7.1.3(b); (v) establish [*] of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY for commercial sale in TERRITORY A, to be submitted to the MANUFACTURE AND SUPPLY SUBTEAM pursuant to Section 9.12.1(b) and 9.12.2; (vi) approve any contract by the Parties relating to the commercialization of PRODUCT in TERRITORY A which is either (a) not included in the JOINT MARKETING PLAN; or (b) is [*]; or (c) contains [*]; (vii) determine [*] sales force deployment by the Parties and sales force strategy consistent with Article 7; (viii) decide on PRODUCT pricing in TERRITORY A, including [*], and matters related to [*], in accordance with Section 7.1.5; (ix) oversee the MANUFACTURING AND SUPPLY CHAIN SUBTEAM, to the extent described in Section 2.3; (x) oversee the FINANCE SUBTEAM, to the extent described in Section 2.4; (xi) oversee matters related to the [*] TERRITORY A; [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 20. 34 (xii) oversee the development of procedures for the handling of product complaints in accordance with Section 7.4; and (xiii) perform any other responsibilities set forth for the JCC in this Agreement. 2.3 MANUFACTURE AND SUPPLY CHAIN SUBTEAM. 2.3.1 FORMATION; MEMBERSHIP. Within thirty (30) days after the Effective Date, the Parties will establish a "MANUFACTURE AND SUPPLY CHAIN SUBTEAM" to oversee the logistics of the manufacture of PRODUCT, the supply and distribution chain for PRODUCT and the MANUFACTURE DEVELOPMENT of the PRODUCT in the FIELD. The MANUFACTURE AND SUPPLY CHAIN SUBTEAM shall be composed of [*] of representatives appointed and replaced by each of Coulter and SB. Each Party will name, from among its representatives, a co-chairperson of the MANUFACTURE AND SUPPLY CHAIN SUBTEAM. The co-chairpersons of the MANUFACTURE AND SUPPLY CHAIN SUBTEAM shall be responsible for the administration of meetings (e.g., calling meetings, preparing and circulating an agenda in advance of each meeting, running the meetings and preparing and issuing written minutes of each meeting within thirty (30) days thereafter) but shall have no additional powers or rights other than those held by virtue of being a representative on the MANUFACTURE AND SUPPLY CHAIN SUBTEAM. Minutes of the MANUFACTURE AND SUPPLY CHAIN SUBTEAM meetings shall be promptly reviewed and shall be deemed approved when mutually accepted by both Parties as evidenced in writing. 2.3.2 DECISION-MAKING. Decisions of the MANUFACTURE AND SUPPLY CHAIN SUBTEAM shall be [*] with each Party having [*]. Should the members of the MANUFACTURE AND SUPPLY CHAIN SUBTEAM [*] on an issue, then after [*] to [*] the issue shall be presented to the JDC for matters relating to DEVELOPMENT or MANUFACTURE DEVELOPMENT and to the JCC for matters relating to commercial supply and all other matters. 2.3.3 MEETINGS. The MANUFACTURE AND SUPPLY CHAIN SUBTEAM shall meet at such times as may be agreed to by the Parties, it being understood that the MANUFACTURE AND SUPPLY CHAIN SUBTEAM will meet at least quarterly unless otherwise agreed by the Parties. Meetings of the MANUFACTURE AND SUPPLY CHAIN SUBTEAM will be held at facilities jointly selected by the Parties. Meetings of the MANUFACTURE AND SUPPLY CHAIN SUBTEAM may be held by video or audio conference with the consent of each Party. Meetings of the MANUFACTURE AND SUPPLY CHAIN SUBTEAM shall be effective only if a representative of each Party is present or participating. Each Party shall bear all expenses it incurs in regard to participating in such meetings of the MANUFACTURE AND SUPPLY CHAIN SUBTEAM, including all travel and living expenses, and such expenses shall not be included in the calculation of COST OF GOODS, DEVELOPMENT COSTS, MANUFACTURE DEVELOPMENT COSTS or included in the JOINT P&L. 2.3.4 SPECIFIC RESPONSIBILITIES OF THE MANUFACTURE AND SUPPLY CHAIN SUBTEAM. In addition to its general responsibility to oversee the logistics of the manufacturing of PRODUCT, the supply and distribution chain for PRODUCT and the MANUFACTURE DEVELOPMENT of the PRODUCT in the FIELD, the MANUFACTURE AND SUPPLY CHAIN SUBTEAM shall in particular: [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 21. 35 (i) prepare, update and implement the JOINT MANUFACTURE DEVELOPMENT PLAN, subject to the approval of the JDC (and the JCC, to the extent the JOINT MANUFACTURE DEVELOPMENT PLAN includes elements related to commercial supply), in accordance with Section 3.3.1; (ii) report to the JDC on manufacture and supply chain matters relating to DEVELOPMENT or MANUFACTURE DEVELOPMENT (excluding commercial supply); (iii) report to the JCC on manufacture and supply chain matters relating to commercial supply in the TERRITORY and all other manufacture and supply chain issues which do not relate to DEVELOPMENT or MANUFACTURE DEVELOPMENT; (iv) prepare an estimate of MANUFACTURE DEVELOPMENT COSTS and QA/QC COSTS for submission to the FINANCE SUBTEAM; (v) together with the JDC regarding supply for DEVELOPMENT and MANUFACTURE DEVELOPMENT and the JCC regarding supply for commercial sale, [*] UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in the event of [*] throughout the TERRITORY, pursuant to Section 9.5; (vi) together with the JDC regarding supply for DEVELOPMENT and MANUFACTURE DEVELOPMENT and the JCC regarding supply for commercial sale, oversee the preparation of forecasts pursuant to Sections 9.12.1 and 9.12.2; and (vii) perform any other responsibilities set forth for the MANUFACTURE AND SUPPLY CHAIN SUBTEAM in this Agreement. 2.4 FINANCE SUBTEAM. 2.4.1 FORMATION; MEMBERSHIP. Within thirty (30) days after the Effective Date, the Parties will establish a "FINANCE SUBTEAM" which shall be composed of as many representatives as each of Coulter and SB shall deem to be necessary. Each Party will name, from among its representatives, a co-chairperson of the FINANCE SUBTEAM. The co-chairpersons of the FINANCE SUBTEAM shall be responsible for the administration of meetings (e.g., calling meetings, preparing and circulating an agenda in advance of each meeting, running the meetings and preparing and issuing written minutes of each meeting within thirty (30) days thereafter) but shall have no additional powers or rights other than those held by virtue of being a representative on the FINANCE SUBTEAM. 2.4.2 MEETINGS. The FINANCE SUBTEAM shall meet at such times as may be agreed to by the members of the FINANCE SUBTEAM. Meetings of the FINANCE SUBTEAM may be held by video or audio conference or at facilities selected by the members of the FINANCE SUBTEAM. Meetings of the FINANCE SUBTEAM shall be effective only if a representative of each Party is present or participating. Each Party shall bear all expenses it incurs in regard to participating in such meetings of the FINANCE SUBTEAM, including all travel and living expenses, [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 22. 36 and such expenses shall not be included in the calculation of COST OF GOODS, DEVELOPMENT COSTS, MANUFACTURE DEVELOPMENT COSTS or included in the JOINT P&L. 2.4.3 RESPONSIBILITIES OF THE FINANCE SUBTEAM. The responsibilities of the FINANCE SUBTEAM shall include, without limitation, (i) overseeing the estimation of DEVELOPMENT COSTS, MANUFACTURE DEVELOPMENT COSTS and [*] under the JOINT P&L, consistent with the terms of this Agreement and subject to necessary approvals by the JDC and JCC; (ii) developing, if possible, and approving a strategy regarding [*], (iii) any other responsibilities set forth for the FINANCE SUBTEAM in this Agreement, and (iv) to the extent determined to be necessary by the members of the FINANCE SUBTEAM, reporting to: (a) the JDC on financial matters relating to DEVELOPMENT or MANUFACTURE DEVELOPMENT in the TERRITORY; (b) the JCC on financial matters relating to commercial sale in TERRITORY A and all other financial issues in TERRITORY A which do not relate to DEVELOPMENT or MANUFACTURE DEVELOPMENT; and (c) the Parties on financial matters relating to commercial sale outside of TERRITORY A and all other financial issues outside of TERRITORY A which do not relate to DEVELOPMENT or MANUFACTURE DEVELOPMENT. ARTICLE 3 DEVELOPMENT OF LICENSED COMPOUND 3.1 INITIAL AND SUBSEQUENT FOCUS OF THE COLLABORATION. The initial focus of the collaboration will be on manufacturing, developing, supplying, and commercializing BEXXAR for the treatment of non-Hodgkin's lymphoma in those MAJOR INDICATIONS outlined in Sections 1.46 [*]. During the term of this Agreement, the JDC will consider, and approve as it deems appropriate, whether the Parties should also pursue the manufacture, development, supply, and commercialization of BEXXAR for the additional MAJOR INDICATIONS not discussed in the preceding sentence (i.e., those outlined in Sections 1.46 [*]) or for [*]. In addition, in the event either Party exercises its option as provided in Sections 4.2.2 and 4.2.4 to manufacture, develop, supply, and commercialize one or more particular SECOND GENERATION LICENSED COMPOUNDS, the Parties will pursue manufacture, development, supply, and commercialization of such SECOND GENERATION LICENSED COMPOUNDS in the FIELD in accordance with Sections 4.2.2 and 4.2.5. 3.2 DEVELOPMENT. 3.2.1 JOINT DEVELOPMENT PLAN. (a) PURPOSE OF JOINT DEVELOPMENT PLAN. The DEVELOPMENT of the PRODUCT will be governed by a "JOINT DEVELOPMENT PLAN". The JOINT DEVELOPMENT PLAN will attempt, to the extent practicable, to describe the plan and budget for DEVELOPMENT of the [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 23. 37 PRODUCT throughout the TERRITORY, including overall DEVELOPMENT strategy, operating guidelines and estimated filing dates, guidelines for filing for REGULATORY APPROVAL, any clinical studies to be conducted and forecasts of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY for clinical supply or other DEVELOPMENT requirements. (b) PREPARATION OF JOINT DEVELOPMENT PLAN. A draft of the initial JOINT DEVELOPMENT PLAN will be prepared by the Parties, in accordance with the allocation of responsibilities set forth in this Section 3.2.1(b), no later than one hundred twenty (120) days after the Effective Date. Thereafter, an updated JOINT DEVELOPMENT PLAN will be drafted and presented to the JDC at such times as the JDC deems appropriate, but no less frequently than annually. [*] will draft that portion of the initial JOINT DEVELOPMENT PLAN and that portion of each annual update of the JOINT DEVELOPMENT PLAN which covers activities, [*] that relate to DEVELOPMENT for purposes of receiving REGULATORY APPROVAL in TERRITORY A only. [*] will draft that portion of the initial JOINT DEVELOPMENT PLAN and that portion of each annual update of the JOINT DEVELOPMENT PLAN which covers activities, including [*], that relate to DEVELOPMENT for purposes of receiving REGULATORY APPROVAL in the [*]. (c) REVIEW AND APPROVAL OF JOINT DEVELOPMENT PLAN. The JDC will review the initial JOINT DEVELOPMENT PLAN and each update thereto and will amend such plan as required to achieve approval by the JDC no later than sixty (60) days after submission of the drafts prepared by the Parties pursuant to Section 3.2.1(b). With respect to the approval of the Non-USA Territory Portion, Coulter, through the JDC, will not withhold its approval of those parts of the Non-USA Territory Portion which are not reasonably likely to have a material effect on DEVELOPMENT or commercialization of PRODUCT in TERRITORY A. When considering the components of the then current JOINT DEVELOPMENT PLAN, the JDC will give strong consideration to the specific regulatory and market needs in each country of the TERRITORY consistent with each Party's employment of COMMERCIALLY REASONABLE EFFORTS with respect to such country. (d) MONITORING OF JOINT DEVELOPMENT PLAN. The JDC will monitor implementation of the initial JOINT DEVELOPMENT PLAN and each update thereto. With respect to monitoring implementation of those parts of the Non-USA Territory Portion which are not reasonably likely to have a material effect on DEVELOPMENT or commercialization of PRODUCT in TERRITORY A, the SB representatives on the JDC will be responsible for such monitoring, but will report to Coulter's representative on the JDC regarding the results of such monitoring, if reasonably requested by Coulter. 3.2.2 IMPLEMENTATION OF DEVELOPMENT. (a) In TERRITORY A, the JDC shall determine those operational areas relating to the DEVELOPMENT for which each Party is responsible (e.g., those clinical trials for which Coulter will have responsibility and those for which SB will have responsibility [*]), consistent with the then current JOINT DEVELOPMENT PLAN and the PLANNED CLINICAL TRIALS. The Parties agree that Coulter will have responsibility for conducting the PLANNED CLINICAL TRIALS in TERRITORY A, unless otherwise agreed by the JDC. A Party which has responsibility for a particular operational area relating to the DEVELOPMENT in TERRITORY A shall make and [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 24. 38 implement any decisions involving such operational area ("Development Operational Decisions"), provided that such Development Operational Decisions and implementation thereof are consistent with the terms of this Agreement, the then current JOINT DEVELOPMENT PLAN, any direction provided by the JDC and Sections 3.2.2(b) and (c). (b) Any Development Operational Decisions made by Coulter in TERRITORY A relating to the following shall be [*] the JDC, subject to ratification by the JDC at the next meeting of the JDC: (i) the review of [*] to make sure that appropriate [*] are included; (ii) [*] to specific investigators; (iii) determination of [*] the PRODUCT which will be [*], and (iv) approval of any [*] and [*] thereto. (c) Any Development Operational Decisions made by SB in TERRITORY A relating to the following shall be approved in advance by [*] JDC, subject to ratification by the JDC at the next meeting of the JDC: (i) the review of selected [*] to make sure that [*] are included; (ii) [*] to specific investigators; (iii) determination of [*] the PRODUCT which will be [*]; and (iv) approval of any [*] and [*] thereto. (d) The list of Development Operational Decisions set forth in Sections 3.2.2(b) and 3.2.2(c) may be expanded or reduced as determined by the JDC. (e) DEVELOPMENT in the NON-USA TERRITORY shall be conducted by the Parties as described in Sections 3.2.4(b). (f) Each Party agrees to use its respective COMMERCIALLY REASONABLE EFFORTS to conduct the DEVELOPMENT with the intent of obtaining REGULATORY APPROVAL in TERRITORY A and in the NON-USA TERRITORY and bringing a PRODUCT to market in the FIELD in the TERRITORY. Neither Party shall subcontract any of its DEVELOPMENT obligations hereunder anywhere in the TERRITORY without the prior approval of the JDC or co-chairpersons of the JDC. 3.2.3 DESIGNATION OF CLINICAL TRIALS. After the Effective Date, at the time the JDC approves a clinical trial, other than a PLANNED CLINICAL TRIAL, pursuant to Section 2.1.4(iii), (each newly approved clinical trial to be known as a "Future Clinical Trial"), it shall decide whether the results of such Future Clinical Trial are most likely to be used primarily in (i) [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 25. 39 TERRITORY A only ("Territory A Trials"), (ii) the NON-USA TERRITORY only ("Non-USA Territory Trials") or (iii) both TERRITORY A and the NON-USA TERRITORY ("Cross-Territory Trials"), and shall designate such Future Clinical Trial accordingly. [*] will have the [*] of [*] the [*] as [*]. The Parties have agreed that [*]. 3.2.4 LEAD PARTY FOR DEVELOPMENT. (a) TERRITORY A. Coulter shall be the lead Party for implementation of the DEVELOPMENT conducted in TERRITORY A, consistent with the terms of this Agreement, the then current JOINT DEVELOPMENT PLAN and any direction provided by the JDC. Such DEVELOPMENT work in TERRITORY A shall include without limitation, PLANNED CLINICAL TRIALS, Territory A Trials (as defined in Section 3.2.3), and Cross-Territory Trials (as defined in Section 3.2.3). (b) NON-USA TERRITORY. (i) Initially, Coulter will be the lead Party for implementation of the DEVELOPMENT conducted in the NON-USA TERRITORY, subject to the terms of this Section 3.2.4 and consistent with the terms of this Agreement, the then current JOINT DEVELOPMENT PLAN and any prior direction provided by the JDC. Such DEVELOPMENT work shall include without limitation, PLANNED CLINICAL TRIALS and Cross-Territory Trials (as defined in Section 3.2.3) that are approved in the then current JOINT DEVELOPMENT PLAN. SB will provide [*] FTE assistance to Coulter in performing clinical trials or other Development work in the NON-USA TERRITORY as identified in the JOINT DEVELOPMENT PLAN and agreed by the JDC. Except [*], all FTE support provided by SB in connection with DEVELOPMENT in the NON-USA TERRITORY shall be provided at [*] expense, [*]. Coulter shall not be responsible for delays in DEVELOPMENT in the NON-USA TERRITORY arising from [*] in the NON-USA TERRITORY in accordance with the then current JOINT DEVELOPMENT PLAN. (ii) [*], SB will become the lead Party for implementation of the DEVELOPMENT conducted in the NON-USA TERRITORY consistent with the terms of this Agreement, the then current JOINT DEVELOPMENT PLAN and any direction provided by the JDC, [*] for the [*]. If SB assumes the role of lead Party for DEVELOPMENT in the NON-USA Territory [*], SB shall [*] the [*], on the [*] with respect to [*]. (iii) At all times, regardless of which Party is the lead Party for implementation of the DEVELOPMENT in the NON-USA TERRITORY, SB shall be responsible for all regulatory work in the NON-USA TERRITORY, including without limitation obtaining necessary approvals for all clinical trial protocols, reporting on adverse events (subject to Section 7.6) and managing other communications with regulatory authorities. In addition, SB shall be at all times responsible for all Non-USA Territory Trials (as defined in Section 3.2.3). Coulter will provide assistance to SB as reasonably requested by SB in conducting such Non-USA Territory Trials and [*] and [*]. SB shall inform the JDC of any significant decisions made by SB or its permitted sublicensees regarding implementation of the then current JOINT DEVELOPMENT PLAN relating to the NON-USA TERRITORY sufficiently in advance of such implementation to enable [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 26. 40 Coulter to comment upon such decisions, and SB shall take such comments into serious consideration but shall not be bound by them. 3.2.5 DEVELOPMENT DILIGENCE MILESTONES IN NON-USA TERRITORY. (a) DEVELOPMENT DILIGENCE MILESTONES IN THE MAJOR MARKET Countries. SB shall seek to file an MAA and an NDS for BEXXAR for the FIRST INDICATION by a date no later than [*] after the BLA for BEXXAR for the FIRST INDICATION has been accepted for review by the FDA in TERRITORY A, provided that each such date shall be extended as required to account for delays which are beyond SB's reasonable control, including, without limitation, [*]. (b) FAILURE TO ACHIEVE MILESTONES. In the event SB determines that it will be unable to achieve a given milestone by [*] (the "Milestone Achievement Date"), either because such date has occurred or because it is reasonably apparent to SB that it will not be able to achieve such milestone by the Milestone Achievement Date, SB shall notify Coulter within thirty (30) days of such determination and the JDC shall meet promptly to work out a plan (the "Milestone Achievement Plan") designed to allow SB to meet such milestone in the given territory [*] of the Milestone Achievement Date, subject to any extension to such date that may be permitted as outlined in [*]. In the event SB is unable to meet such milestone in such territory within such [*] but has made good faith efforts to do so consistent with the Milestone Achievement Plan, provided that such date shall be extended as required to account for delays which are beyond SB's reasonable control, the JDC shall meet promptly after the end of such [*] period to work out an extended plan (the "Extended Milestone Achievement Plan") designed to allow SB to meet such milestone in the given territory within [*] of the Milestone Achievement Date, provided that such date shall be extended as required to account for delays which are beyond SB's reasonable control. In the event SB (i) has not made good faith efforts to meet a milestone within [*] under the Milestone Achievement Plan in a given MAJOR MARKET COUNTRY, subject to any extension permitted under Section 3.2.5(a) or (ii) is unable to meet a milestone for any reason within [*] of the Milestone Achievement Date under the Extended Milestone Achievement Plan in such MAJOR MARKET COUNTRY, subject to any extension permitted under [*], the licenses granted by Coulter under this Agreement shall be automatically adjusted to exclude the MAJOR MARKET COUNTRY in which such milestone was not achieved and the terms of Section 13.4 shall apply for such MAJOR MARKET COUNTRY. 3.2.6 FUNDING OF DEVELOPMENT. [*] shall bear the cost of [*] and [*] aggregate [*] (including, without limitation, [*] related to [*]) [*], provided that it is understood that no expenses of [*] shall be [*] used to [*] unless [*] are [*] or are within [*]. [*]. (a) [*] shall be [*] and handled as set forth in [*]; and (b) DEVELOPMENT COSTS shall be shared by the Parties as follows: (i) SB will bear the SB Share of Development Costs (as defined below) and Coulter will bear the Coulter Share of Development Costs (as defined below). [*]. No expenses of a Party shall be included within DEVELOPMENT COSTS except as provided in Section 1.15. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 27. 41 (ii) The Parties agree that: (1) "SB Share of Development Costs" shall equal A + B + C, where A = [*] multiplied by all DEVELOPMENT COSTS associated with Cross-Territory Trials (as defined in Section 3.2.3) incurred [*]; and B = [*] multiplied by all DEVELOPMENT COSTS associated with Territory A Trials (as defined in Section 3.2.3) and incurred [*]; and C = [*] multiplied by all DEVELOPMENT COSTS associated with Non-USA Territory Trials (as defined in Section 3.2.3) and incurred after October 1, 1998. (2) "Coulter Share of Development Costs" shall equal D + E, where D = [*] multiplied by all DEVELOPMENT COSTS associated with all Cross-Territory Trials (as defined in Section 3.2.3) incurred [*]; and E = [*] multiplied by all DEVELOPMENT COSTS associated with Territory A Trials (as defined in Section 3.2.3) incurred [*]. (3) Notwithstanding the foregoing, in the event that the JDC uses data from a Non-USA Territory Trial to support a regulatory filing to demonstrate the efficacy of the PRODUCT regarding a previously unapproved indication for purposes of label expansion in TERRITORY A, then upon the date of filing for such label expansion in TERRITORY A, Coulter shall reimburse to SB [*] of the costs of such Non-USA Territory Trial even if such filing [*]; provided, however, that the amount of such payment by Coulter shall be included in [*] used to [*]. Further, in the event that SB uses data from a Territory A Trial to demonstrate the efficacy of the PRODUCT regarding a previously unapproved indication for purposes of label expansion in the NON-USA TERRITORY, then upon the date of filing for such label expansion in the NON-USA TERRITORY, SB shall reimburse to Coulter [*] of the costs of such Territory A Trial (i.e., [*] from [*]). (iii) No later than thirty (30) days after the end of each calendar quarter, each Party shall submit to the FINANCE SUBTEAM an accounting of all DEVELOPMENT COSTS incurred by such Party during such quarter. The FINANCE SUBTEAM shall promptly calculate whether any payments are due from one Party to the other Party under this Section. In the event such payment is due, the Party which owes the payment shall make such payment to the other Party within thirty (30) days after it has received such a determination, in writing, from the FINANCE SUBTEAM. The Party receiving the payment shall issue an invoice to the Party making the payment which invoice shall be in the amount to be paid. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 28. 42 (c) Notwithstanding Section 3.2.4(b)(i) and Section 3.2.6(a), in the event that the actual FTE assistance provided to Coulter by SB to support Cross-Territory Trials exceeds the FTE amounts set forth in the initial JOINT DEVELOPMENT PLAN approved by the JDC by greater than [*], then the total amount of such additional FTE assistance in excess of such approved amount, to the extent approved by the JDC, [*]. 3.3 MANUFACTURE DEVELOPMENT. 3.3.1 JOINT MANUFACTURE DEVELOPMENT PLAN. (a) PURPOSE OF JOINT MANUFACTURE DEVELOPMENT PLAN. The MANUFACTURE DEVELOPMENT of the PRODUCT will be governed by a "JOINT MANUFACTURE DEVELOPMENT PLAN." The JOINT MANUFACTURE DEVELOPMENT PLAN will attempt, to the extent practicable, to describe the plan and budget for the MANUFACTURE DEVELOPMENT of the PRODUCT throughout the TERRITORY, including without limitation, process development and optimization, manufacturing scale-up, validation, qualification, and certification, [*] equipment for the manufacture of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY. (b) PREPARATION OF JOINT MANUFACTURE DEVELOPMENT PLAN. A draft of the initial JOINT MANUFACTURE DEVELOPMENT PLAN will be prepared and approved by the MANUFACTURE AND SUPPLY CHAIN SUBTEAM pursuant to Section 2.3.4(i), no later than ninety (90) days after the Effective Date. Thereafter, an updated JOINT MANUFACTURE DEVELOPMENT PLAN will be drafted and presented to the JDC (and the JCC, to the extent such JOINT MANUFACTURE DEVELOPMENT PLAN includes elements related to commercial supply) at such times as the JDC and/or JCC, as applicable, deems appropriate, but no less frequently than annually. (c) REVIEW AND APPROVAL OF JOINT MANUFACTURE DEVELOPMENT PLAN. The JDC (and the JCC, to the extent such JOINT MANUFACTURE DEVELOPMENT PLAN includes elements related to commercial supply) will review the initial JOINT MANUFACTURE DEVELOPMENT PLAN and each update thereto and will amend such plan as required to achieve approval by the JDC (and the JCC, to the extent such JOINT MANUFACTURE DEVELOPMENT PLAN includes elements related to commercial supply) no later than seventy-five (75) days after submission of the drafts prepared by the MANUFACTURE AND SUPPLY CHAIN SUBTEAM pursuant to Section 3.3.1(b). When considering the components of the then current JOINT MANUFACTURE DEVELOPMENT PLAN, the JDC will give strong consideration to the specific regulatory and market needs in each country of the TERRITORY consistent with each Party's employment of COMMERCIALLY REASONABLE EFFORTS with respect to such country. (d) MONITORING OF JOINT MANUFACTURE DEVELOPMENT PLAN. The JDC will monitor implementation of the initial JOINT MANUFACTURE DEVELOPMENT PLAN and each update thereto. With respect to monitoring implementation of those parts of the JOINT MANUFACTURE DEVELOPMENT PLAN relating to the NON-USA TERRITORY which are not reasonably likely to have a material effect on DEVELOPMENT or commercialization of PRODUCT in TERRITORY A, the SB representatives on the JDC will be responsible for such monitoring, but will report to Coulter's representative on the JDC regarding the results of such monitoring, if reasonably requested by Coulter. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 29. 43 (e) INTERNAL APPROVALS. Each Party shall endeavor to obtain all necessary internal approvals for capital expenditures in a manner that supports the timely implementation of the JOINT DEVELOPMENT PLAN and the JOINT MANUFACTURE DEVELOPMENT PLAN and so as not to delay PRODUCT regulatory filings and the PRODUCT timelines in accordance with its internal procedures normally employed for such matters and in accordance with its COMMERCIALLY REASONABLE EFFORTS. Notwithstanding the above, each Party shall only be liable to make [*] in accordance with the then approved JOINT MANUFACTURE DEVELOPMENT PLAN, or in accordance with the approved expenses outlined in Section 1.51(i). 3.3.2 LEAD PARTY FOR MANUFACTURE DEVELOPMENT. (a) UNCONJUGATED ANTIBODY MANUFACTURE DEVELOPMENT. [*] will take the lead with respect to the MANUFACTURE DEVELOPMENT of UNCONJUGATED ANTIBODY unless [*], at which [*]. The JDC can adjust the responsibilities of the Parties with respect to the MANUFACTURE DEVELOPMENT of UNCONJUGATED ANTIBODY as it deems appropriate. (b) RADIOLABELED ANTIBODY MANUFACTURE DEVELOPMENT. [*] will take the lead with respect to the MANUFACTURE DEVELOPMENT of any RADIOLABELED ANTIBODY to the extent that such occurs in connection with [*] otherwise for supply in TERRITORY A. [*] will take the lead with respect to the MANUFACTURE DEVELOPMENT of any RADIOLABELED ANTIBODY to the extent that such occurs in connection with a EUROPEAN FACILITY (as defined in Section 9.10.1) other than [*]. The JDC (based on the recommendation of the MANUFACTURING AND SUPPLY CHAIN SUBTEAM) will determine which Party shall take the lead on any other activities related to the MANUFACTURE DEVELOPMENT of any RADIOLABELED ANTIBODY. Further, the JDC can adjust the responsibilities of the Parties with respect to the MANUFACTURE DEVELOPMENT of RADIOLABELED ANTIBODY as it deems appropriate. 3.3.3 FUNDING OF MANUFACTURE DEVELOPMENT (a) CAPITAL AND NON-CAPITAL EXPENDITURES (i) Any MANUFACTURE DEVELOPMENT COSTS which are incurred by either Party with respect to activities related solely to TERRITORY A shall be borne [*]. (ii) Any MANUFACTURE DEVELOPMENT COSTS which are incurred by either Party with respect to activities related solely to outside of TERRITORY A shall be borne [*]. (iii) Any MANUFACTURE DEVELOPMENT COSTS which are incurred by either Party with respect to activities both inside and outside of TERRITORY A shall be borne [*]. (iv) No later than thirty (30) days after the end of each calendar quarter, each Party shall submit to the FINANCE SUBTEAM established by Section 2.4 an accounting of all MANUFACTURING DEVELOPMENT COSTS incurred by such Party during such quarter. The FINANCE SUBTEAM shall promptly calculate whether any payments are due from one [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 30. 44 Party to the other Party under this Section. In the event such payment is due, the Party which owes the payment shall make such payment to the other Party within thirty (30) days after it has received such a determination, in writing, from the FINANCE SUBTEAM. The Party receiving the payment shall issue an invoice to the Party making the payment which invoice shall be in the amount to be paid. (b) ECONOMIC INTEREST IN CAPITAL EXPENDITURES. (i) Coulter [*] SB shall have [*] in any fixed assets derived from such MANUFACTURE DEVELOPMENT COSTS incurred under Section 3.3.3(a)(i), in accordance with mechanisms to be agreed by the Parties. (ii) SB [*] any fixed assets derived from MANUFACTURE DEVELOPMENT COSTS incurred under Section 3.3.3(a)(ii). (iii) Coulter [*] SB shall have [*] in any fixed assets derived from such MANUFACTURE DEVELOPMENT COSTS incurred jointly under Section 3.3.3(a)(iii) in the [*], such economic interest to be structured in accordance with mechanisms to be agreed by the Parties. 3.4 RECORDS, REPORTS AND INFORMATION EXCHANGE. 3.4.1 TECHNOLOGY AND INFORMATION TRANSFER. Following the Effective Date, Coulter will promptly provide to SB all KNOW-HOW and other information, including, but not limited to, preclinical and clinical data, as SB reasonably deems necessary to enable it to carry out the DEVELOPMENT and MANUFACTURE DEVELOPMENT of LICENSED COMPOUND and PRODUCT and commercialization of PRODUCT and to obtain REGULATORY APPROVAL throughout the TERRITORY. Thereafter, during the term of this Agreement, each Party shall promptly make available to the other all KNOW-HOW and other information, including, but not limited to, preclinical and clinical data, as such Party reasonably deems necessary to carry out the DEVELOPMENT and MANUFACTURE DEVELOPMENT of LICENSED COMPOUND and PRODUCT and commercialization of PRODUCT and to obtain REGULATORY APPROVAL throughout the TERRITORY. All information transferred, provided or exchanged under this Section 3.4.1 will be subject to the confidentiality requirements set forth in Article 17. 3.4.2 RECORD KEEPING. With respect to the DEVELOPMENT and MANUFACTURE DEVELOPMENT work conducted by or on behalf of a given Party, such Party will maintain records in sufficient detail and in good scientific manner appropriate for REGULATORY APPROVAL and patent purposes. 3.5 REGULATORY COMPLIANCE. Each Party shall comply with GLP, GCP, GMP and all other applicable governmental, regulatory and administrative laws, rules and regulations of the FDA and other applicable authorities in the conduct of the DEVELOPMENT, MANUFACTURE DEVELOPMENT and in preparing and filing all regulatory dossiers for PRODUCT in the TERRITORY. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 31. 45 3.6 REGULATORY APPROVALS. 3.6.1 TERRITORY A. Coulter shall file all regulatory dossiers (e.g., the BLA) for PRODUCT in the FIELD in TERRITORY A under its name in accordance with the use of its COMMERCIALLY REASONABLE EFFORTS. Coulter shall own all such TERRITORY A REGULATORY APPROVALS. To the extent legally permissible, SB shall have the right of reference to the extent necessary to exercise its rights or to meet its obligations hereunder. Coulter shall be responsible for undertaking all activities required of the holder of regulatory dossiers in TERRITORY A, including, but not limited to, any adverse event reporting (subject to Section 7.6). Coulter shall be responsible for all communications with regulatory agencies relating to the PRODUCT in the FIELD in TERRITORY A, subject to its obligation to keep the JDC and/or the JCC informed. 3.6.2 NON-USA TERRITORY. (a) SB RESPONSIBILITIES. SB shall file all regulatory dossiers, as well as any necessary or desired pricing approvals, for PRODUCT in the FIELD in the NON-USA TERRITORY under its name in accordance with the use of its COMMERCIALLY REASONABLE EFFORTS. SB shall own all such NON-USA TERRITORY REGULATORY APPROVALS. To the extent legally permissible, Coulter shall have the right of reference to the extent necessary to exercise its rights or to meet its obligations hereunder. SB shall be responsible for undertaking all activities required of the holder of regulatory dossiers in the NON-USA TERRITORY, including, but not limited to, any adverse event reporting (subject to Section 7.6). SB shall be responsible for all communications with regulatory agencies relating to the PRODUCT in the FIELD in the NON-USA TERRITORY, subject to its obligation to keep the JDC and/or the JCC informed. (b) COULTER RESPONSIBILITY TO PROVIDE TECHNICAL ASSISTANCE IN THE NON-USA TERRITORY. Coulter shall provide to SB, at SB's request, reasonable technical assistance within Coulter's area of expertise concerning registration of PRODUCT in the NON-USA TERRITORY. Provision of such technical assistance shall include, but not be limited to, supply of any KNOW-HOW owned or CONTROLLED by Coulter which SB may require. Pursuant to such obligation, Coulter shall make available to SB, Coulter's representatives as are reasonably requested by SB in connection with regulatory and scientific matters relating to the filing of regulatory applications in the NON-USA TERRITORY, including timely response to questions raised by regulatory authorities regarding the MAA or equivalent regulatory filings in the NON-USA TERRITORY, and travel as reasonably required for meetings with regulatory authorities. In the event that SB requests that Coulter perform work under this Section 3.6.2(b), SB shall reimburse Coulter for [*] OUT-OF-POCKET COSTS incurred by Coulter with respect to such performance within thirty (30) days of receipt of an invoice from Coulter, provided that [*] incurred by Coulter under this Section 3.6.2(b) shall be based on [*]. Such OUT-OF-POCKET COSTS shall not be deemed to be DEVELOPMENT COSTS. All work or other assistance provided to SB under this Section 3.6.2(b), such as, without limitation, [*], and the provision of existing Coulter reports, data and information to assist SB with responses to questions or requests from regulatory authorities, shall be provided to SB [*] in the case where (i) a Coulter FTE is requested by SB [*] or (ii) Coulter is requested to undertake an individual project that requires more than [*], provided that Coulter provides SB [*] that the project is of such a magnitude. In the event that [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 32. 46 [*], SB shall [*] Coulter, on an FTE rate basis for the [*] rendering such assistance, at an FTE rate of [*]. ARTICLE 4 ADDITIONAL INDICATIONS; SECOND GENERATION LICENSED COMPOUNDS 4.1 ADDITIONAL INDICATIONS. Upon the prior approval of the JDC, each of SB and Coulter shall have the right to conduct research and pre-clinical development of any LICENSED COMPOUND for any ADDITIONAL INDICATIONS. Unless agreed otherwise by the Parties, the cost of such research and pre-clinical development for an ADDITIONAL INDICATION shall be [*]. If, based on such pre-clinical research and development, SB or Coulter discovers or determines that any LICENSED COMPOUND may have efficacy in the treatment, prevention or palliation of any ADDITIONAL INDICATION and if such Party desires to pursue clinical trials of such LICENSED COMPOUND for such ADDITIONAL INDICATION, it will promptly notify the other Party in writing and disclose to the other Party its rationale therefor, including all relevant data. Through the JDC, the Parties will then decide whether to go forward with the DEVELOPMENT and commercialization of the LICENSED COMPOUND for such ADDITIONAL INDICATION pursuant to this Agreement. In the event the JDC decides not to go forward with the DEVELOPMENT and commercialization of the LICENSED COMPOUND for such ADDITIONAL INDICATION, [*]. In the event the JDC does decide to go forward, [*] will be the lead Party in pursuing DEVELOPMENT for the ADDITIONAL INDICATION in TERRITORY A and [*] will be the lead Party in pursuing DEVELOPMENT for the ADDITIONAL INDICATION in TERRITORY B and TERRITORY C unless otherwise determined by the JDC. 4.2 SECOND GENERATION LICENSED COMPOUNDS. 4.2.1 SECOND GENERATION LICENSED COMPOUND CANDIDATES; REPORTING; NOTICE. (a) The Parties intend during the term of this Agreement to work cooperatively to evaluate the feasibility of developing SECOND GENERATION LICENSED COMPOUND CANDIDATES, while maintaining their independent ability to develop such compounds, subject to the terms of this Section 4.2. Accordingly, the Parties agree that, at any time during the term of this Agreement, either Party may elect, [*], to pursue research and development of a specific SECOND GENERATION LICENSED COMPOUND CANDIDATE in the FIELD. The Party making the foregoing election shall be deemed to be the "Initiating Party". (b) The Initiating Party shall [*] (the "Non-Initiating Party") promptly following its commencement of any work related to a SECOND GENERATION LICENSED COMPOUND CANDIDATE in the FIELD, and shall [*] keep the Non-Initiating Party informed of the results of any such research and development and shall make appropriate personnel available, at reasonable times, to discuss with the Non-Initiating Party the attributes of the SECOND GENERATION LICENSED COMPOUND CANDIDATE and any studies the Initiating Party has undertaken relating to the research and development of such SECOND GENERATION LICENSED COMPOUND CANDIDATE in the [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 33. 47 FIELD. The Initiating Party shall provide written [*] reports to the JDC on the status of research and development of such SECOND GENERATION LICENSED COMPOUND CANDIDATE in the FIELD. On a [*], subject to Section 4.2.3, the Initiating Party shall provide the Non-Initiating Party with a summary of the SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and the SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS to date in developing such SECOND GENERATION LICENSED COMPOUND CANDIDATE, with such costs [*]. (c) The Initiating Party shall provide written notice to the Non-Initiating Party no later than [*] prior to the date on which the Initiating Party plans to [*] for such SECOND GENERATION LICENSED COMPOUND CANDIDATE in the FIELD. Such written notice shall include the planned filing date, as well as all material information developed or obtained by the Initiating Party relevant to its interest in the SECOND GENERATION LICENSED COMPOUND CANDIDATE in the FIELD not previously provided to the Non-Initiating Party. (d) The Initiating Party shall provide written notice to the Non-Initiating Party no later than [*] prior to the date on which the Initiating Party plans to [*] for such SECOND GENERATION LICENSED COMPOUND CANDIDATE in the FIELD. Such written notice shall include the [*] as well as all material information developed or obtained by the Initiating Party, and not previously provided to the Non-Initiating Party, which is relevant to the Initiating Party's interest in the SECOND GENERATION LICENSED COMPOUND CANDIDATE in the FIELD. 4.2.2 SB DEVELOPMENT AND COMMERCIALIZATION OPTION. (a) In the event Coulter is the Initiating Party, at any time after receipt of Coulter's first [*] report pursuant to Section 4.2.1(b) and until [*] after Coulter provides notice to SB of Completion of [*], required for such SECOND GENERATION LICENSED COMPOUND CANDIDATE (the "SB Option Termination Date"), SB may provide written notice to Coulter indicating that it is interested in pursuing the development and commercialization of such SECOND GENERATION LICENSED COMPOUND CANDIDATE in the FIELD (an "SB Option Exercise Notice"). In the event SB provides an SB Option Exercise Notice on or before the SB Option Termination Date, such SECOND GENERATION LICENSED COMPOUND CANDIDATE shall thereafter be deemed to be a SECOND GENERATION LICENSED COMPOUND for purposes of this Agreement and the terms of Section 4.2.2(b) and 4.2.5 shall apply. The SB Option Termination Date [*]. (b) Within [*] days of Coulter's receipt of an SB Option Exercise Notice, SB shall reimburse Coulter for [*] of the SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and [*] of the SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS associated with such SECOND GENERATION LICENSED COMPOUND CANDIDATE; provided, however, if the SB Option Exercise Notice is delivered by SB [*] Coulter provides SB with notice of the Completion of Phase II Trials (as defined in Section 4.2.2(c)) for such SECOND GENERATION LICENSED COMPOUND CANDIDATE and on or before the SB Option Termination Date, SB shall reimburse Coulter for [*] of such SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and [*] of such SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 34. 48 (c) "Completion of Phase II Trials" shall be deemed to have occurred with respect to a given SECOND GENERATION LICENSED COMPOUND CANDIDATE in the FIELD when the Initiating Party has given written notice to the Non-Initiating Party that (i) the Initiating Party has [*] which the Initiating Party [*]; (ii) the Initiating Party has [*]; and (iii) the Initiating Party has [*] and has [*] and [*] was [*]. Included with such notice shall be (w) a written report containing all material information and studies developed or obtained by the Initiating Party relevant to the SECOND GENERATION LICENSED COMPOUND CANDIDATE in the FIELD as of such date; (x) a copy of the [*]; (y) a summary prepared by the Initiating Party of the [*] a [*] the [*]; and (z) [*] the SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and the SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS to date with respect to such SECOND GENERATION LICENSED COMPOUND CANDIDATE, with such costs [*]. In the event the Initiating Party has determined in good faith that [*] on the [*] such [*] to [*] on [*] to the [*]. Included with such notice shall be a written report containing all information and studies developed or obtained by the Initiating Party relevant to the SECOND GENERATION LICENSED COMPOUND CANDIDATE in the FIELD as of such date, [*] of the SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and the SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS to date with respect to such SECOND GENERATION LICENSED COMPOUND CANDIDATE, with such costs [*]. (d) A "Second Generation Licensed Compound Candidate Pivotal Trial" shall mean a study in humans which is prospectively designed to demonstrate statistically whether a given SECOND GENERATION LICENSED COMPOUND CANDIDATE is safe and effective for use in the FIELD in a manner necessary to obtain REGULATORY APPROVAL to market such compound for use in the FIELD. (e) A "Phase II Trial" shall mean that portion of clinical development of pharmaceutical PRODUCTS that provides for additional assessment of safety and preliminary assessment of efficacy at particular dosage levels of a SECOND GENERATION LICENSED COMPOUND CANDIDATE, in human patients, which is intended to gather information to support the pivotal human clinical trials using the SECOND GENERATION LICENSED COMPOUND CANDIDATE, performed in accordance with the FD&C ACT and applicable regulations promulgated thereunder (including, without limitation, 21 CFR Part 312), as amended from time to time, or any comparable foreign laws and regulations. 4.2.3 IF COULTER IS THE INITIATING PARTY AND SB DOES NOT PROVIDE AN SB OPTION EXERCISE NOTICE. In the event Coulter is the Initiating Party and SB does not provide an SB OPTION EXERCISE NOTICE with respect to a given SECOND GENERATION LICENSED COMPOUND CANDIDATE by the SB Option Termination Date (as such may be extended by Coulter under Section 4.2.2(a)), Coulter shall [*] with respect to such SECOND GENERATION LICENSED COMPOUND CANDIDATE and shall [*]. In the event Coulter, a Coulter AFFILIATE or a Coulter THIRD PARTY licensee commences a Second Generation Licensed Compound Candidate Pivotal Trial on such compound, Coulter shall notify SB. In the event Coulter has completed a Second Generation Licensed Compound Candidate Pivotal Trial (as defined in Section 4.2.2(d)) and has decided to file a BLA on the basis of such trial, Coulter shall immediately provide written notice to SB of such decision. In the event Coulter receives REGULATORY APPROVAL to sell such SECOND [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 35. 49 GENERATION LICENSED COMPOUND CANDIDATE in TERRITORY A and has not, as of the date on which such REGULATORY APPROVAL is received, [*] an [*] to [*] in TERRITORY A or otherwise [*] the [*] to [*] in TERRITORY A, Coulter shall immediately provide written notice to SB of such situation. At any time within [*] days of the date of Coulter's notice as set forth in the previous sentence, SB may, upon written notice to Coulter, require Coulter to make the election set forth in Section 7.1.15, provided that, in such event, Coulter's right to participate in the CO-PROMOTION of PRODUCT in TERRITORY A will cease immediately upon such election. In the event SB does not provide an SB OPTION EXERCISE NOTICE on or before the SB Option Termination Date, the obligations of Coulter contained in Section 4.2.1(b) shall terminate as of the SB Option Termination Date, but the provisions of this Section 4.2.3 shall still apply. 4.2.4 COULTER DEVELOPMENT AND COMMERCIALIZATION RIGHTS; COULTER FUNDING OPTION. (a) AUTOMATIC CONVERSION OF SECOND GENERATION LICENSED COMPOUND CANDIDATE TO SECOND GENERATION LICENSED COMPOUND. The Parties understand that, in the event SB is the Initiating Party for a SECOND GENERATION LICENSED COMPOUND CANDIDATE, such compound will automatically be converted to a SECOND GENERATION LICENSED COMPOUND at the time set forth in Section 4.2.4(b). Coulter's payment obligations and economic participation with respect to such compound are set forth in this Section 4.2.4. (b) EXERCISE OF FUNDING OPTION. In the event SB is the Initiating Party, at any time after receipt of SB's first [*] report pursuant to Section 4.2.1(b) and [*] SB discloses to Coulter the Pivotal Trial Data (as defined in this Section 4.2.4(b)) for such SECOND GENERATION LICENSED COMPOUND CANDIDATE (the "Coulter Funding Option Termination Date"), Coulter may provide written notice to SB indicating that it is interested in reimbursing SB for a portion of the SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and the SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS (a "Coulter Funding Option Exercise Notice") as set forth in Section 4.2.4(c)(i) or 4.2.4(c)(ii). As of the date on which Coulter provides a Coulter Funding Option Exercise Notice, such SECOND GENERATION LICENSED COMPOUND CANDIDATE shall be deemed to be a SECOND GENERATION LICENSED COMPOUND and the terms of Sections 4.2.4(c)(i), 4.2.4(c)(ii) and 4.2.5 shall apply. In the event Coulter does not provide a Coulter Funding Option Exercise Notice on or before the Coulter Funding Option Termination Date, such SECOND GENERATION LICENSED COMPOUND CANDIDATE automatically shall be deemed to be a SECOND GENERATION LICENSED COMPOUND as of the Coulter Funding Option Termination Date and the terms of Sections 4.2.4(c)(iii) and 4.2.5 shall apply. "Pivotal Trial Data" shall mean clinical data from a study in humans which [*], demonstrate statistically that PRODUCT containing a SECOND GENERATION LICENSED COMPOUND CANDIDATE is safe and effective for use in the FIELD in a manner necessary to obtain REGULATORY APPROVAL to market PRODUCT in TERRITORY A for use in the FIELD. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 36. 50 (c) PAYMENT OBLIGATIONS OF COULTER. (i) In the event SB is the Initiating Party for a given SECOND GENERATION LICENSED COMPOUND CANDIDATE and Coulter provides the Coulter Funding Option Exercise Notice to SB before the Completion of Phase II Trials (as defined in Section 4.2.2(c)) for such compound, within [*] of delivery of such notice, Coulter shall reimburse SB for [*] of the SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and [*] of the SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS associated with seeking REGULATORY APPROVAL for such compound in TERRITORY A. (ii) In the event SB is the Initiating Party for a given SECOND GENERATION LICENSED COMPOUND CANDIDATE and Coulter provides the Coulter Funding Option Exercise Notice to SB on or after the Completion of Phase II Trials (as defined in Section 4.2.2(c)) for such compound and on or before the Coulter Funding Option Termination Date for such compound, within [*] days of delivery of such notice, Coulter shall reimburse SB for [*] of the SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and [*] of the SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS associated with seeking REGULATORY APPROVAL for such compound in TERRITORY A. (iii) In the event SB is the Initiating Party for a given SECOND GENERATION LICENSED COMPOUND CANDIDATE and Coulter does not provide the Coulter Funding Option Exercise Notice to SB on or before the Coulter Funding Option Termination Date for such compound, (i) SB shall owe no milestones to Coulter with respect to such compound pursuant to Section 6.3 and (ii) SB shall pay [*] of the SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and the SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS and any other DEVELOPMENT COSTS or MANUFACTURE DEVELOPMENT COSTS for such compound once such SECOND GENERATION LICENSED COMPOUND CANDIDATE becomes a SECOND GENERATION LICENSED COMPOUND pursuant to Section 4.2.4(b), but may offset [*] of the SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and [*] of the SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS associated with seeking REGULATORY APPROVAL for such compound in TERRITORY A and [*] of any other DEVELOPMENT COSTS and MANUFACTURE DEVELOPMENT COSTS associated with seeking REGULATORY APPROVAL for such compound in TERRITORY A, against Coulter's [*] share of OPERATING PROFIT in TERRITORY A, pursuant to Section 7.1.13, for PRODUCT containing such compound. 4.2.5 MODIFICATION OF JOINT DEVELOPMENT PLAN, JOINT MANUFACTURE DEVELOPMENT PLAN AND JOINT MARKETING PLAN. Promptly upon a SECOND GENERATION LICENSED COMPOUND Candidate becoming a SECOND GENERATION LICENSED COMPOUND pursuant to Section 4.2.2(a) or 4.2.4(b), the JDC and JCC shall modify the JOINT DEVELOPMENT PLAN, the JOINT MANUFACTURE DEVELOPMENT PLAN and the JOINT MARKETING PLAN then in effect as required to achieve the requisite approvals of the modified documents by the JDC and JCC, following the procedures set forth in Article 2, in order to incorporate the SECOND GENERATION LICENSED COMPOUND into such documents. Consistent with this Agreement and the modified JOINT DEVELOPMENT PLAN, the modified JOINT MANUFACTURE DEVELOPMENT PLAN and modified JOINT [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 37. 51 MARKETING PLAN, the JDC and JCC shall allocate responsibility for the DEVELOPMENT, MANUFACTURE DEVELOPMENT and commercialization of such SECOND GENERATION LICENSED COMPOUND, provided, however, such allocation shall be [*]. ARTICLE 5 LICENSES 5.1 LICENSES TO SB. Subject to the other provisions of this Agreement, Coulter hereby grants to SB: 5.1.1 A license, under Coulter's INTELLECTUAL PROPERTY RIGHTS, to develop, make, have made, use, sell, offer for sale, and import LICENSED COMPOUND, PRODUCT and ANTI-CD20 ANTIBODY in the FIELD in TERRITORY A, subject to Section 5.1.3 and Section 5.1.4 and the other terms and conditions set forth in this Agreement. Such license shall be exclusive except as to Coulter and shall be subject to the terms set forth in this Agreement. 5.1.2 A license, under Coulter's INTELLECTUAL PROPERTY RIGHTS, to develop, make, have made, use, sell, offer for sale, and import LICENSED COMPOUND, PRODUCT and ANTI-CD20 ANTIBODY in the FIELD in the NON-USA TERRITORY, subject to Section 5.1.3 and Section 5.1.4 and the other terms and conditions set forth in this Agreement (including without limitation circumstances under which SB's rights in certain countries may terminate or become non-exclusive). Such license shall be exclusive except as to Coulter's rights (i) to develop, make, have made, use and import LICENSED COMPOUND and PRODUCT for SB in the Field in the NON-USA TERRITORY as set forth in this Agreement and (ii) as described in Section 5.1.4. 5.1.3 The license to SB outlined in Sections 5.1.1 and 5.1.2 shall be exercisable by SB only with respect to (a) PRODUCT or LICENSED COMPOUND; and (b) SECOND GENERATION LICENSED COMPOUND CANDIDATEs for use in the FIELD throughout the TERRITORY, but only to the extent set forth in Section 4.2. 5.1.4 As used in Sections 5.1.1 and 5.1.2, a license that is "exclusive except as to Coulter" means that Coulter shall not grant any other entity (other than Coulter AFFILIATES but only for so long as they remain AFFILIATES) any license under Coulter's INTELLECTUAL PROPERTY RIGHTS in the FIELD except as otherwise provided in Section 11.4.3, but that otherwise Coulter retains all its rights of ownership in such licensed rights, including without limitation the right to practice such property rights, subject only to the license granted. In particular, Coulter shall retain the right to develop, make, have made, use, sell, offer for sale and import LICENSED COMPOUND and PRODUCT in the FIELD in TERRITORY A, and to develop, make, have made, and use SECOND GENERATION LICENSED COMPOUND CANDIDATES and LICENSED COMPOUNDS in the FIELD throughout the TERRITORY, in all cases subject to the terms set forth in this Agreement. For the avoidance of doubt, nothing contained in this Section 5.1 (a) grants SB any rights under Coulter's INTELLECTUAL PROPERTY RIGHTS outside the FIELD, (b) grants SB the right to exercise its [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 38. 52 license for products other than the PRODUCT, LICENSED COMPOUND and SECOND GENERATION LICENSED COMPOUND CANDIDATEs (subject to Section 4.2), (c) precludes Coulter or any licensee of Coulter from practicing such rights outside the FIELD or for a purpose not related to ANTI-CD20 ANTIBODIES in the FIELD, or (d) grants Coulter the right to exercise its retained rights related to ANTI-CD20 ANTIBODIES for products other than the PRODUCT, LICENSED COMPOUND and SECOND GENERATION LICENSED COMPOUND CANDIDATEs (subject to Section 4.2). 5.1.5 Under no circumstances may SB grant sublicenses in TERRITORY A under the licenses granted in this Section 5.1 except to AFFILIATES of SB and only for so long as such AFFILIATES remain AFFILIATES (except in the event that Coulter loses its rights to CO-PROMOTE PRODUCT under Section 7.1.15) and only to develop, make, have made, use, sell, offer for sale and import PRODUCT, LICENSED COMPOUND, and SECOND GENERATION LICENSED COMPOUND CANDIDATES. Subject to Section 7.2.3, the licenses granted in this Section 5.1 shall only be sublicensable by SB in the MAJOR MARKET COUNTRIES with the prior written consent of Coulter which shall not be unreasonably withheld, except SB may grant sublicenses in the MAJOR MARKET COUNTRIES to AFFILIATES of SB, and only for so long as such AFFILIATES remain AFFILIATES, without the prior consent of Coulter. In all countries other than the TERRITORY A and the MAJOR MARKET COUNTRIES, SB may grant sublicenses under the licenses granted in this Section 5.1 without the prior consent of Coulter, provided, however, SB shall provide written notice to Coulter at least five (5) business days prior to entering into such sublicense agreements. Such notice shall include the name of the THIRD PARTY sublicensee and a brief description of the proposed agreement. 5.1.6 Unless otherwise provided in this Agreement, SB covenants that it shall not, nor shall it cause any AFFILIATE to knowingly, use or practice directly or indirectly any INTELLECTUAL PROPERTY RIGHTS of Coulter for any purposes other than those set forth in Sections 5.1.1, 5.1.2 and 5.1.3. 5.2 LICENSES TO COULTER. 5.2.1 Subject to the other provisions of this Agreement, SB hereby grants to Coulter a license under SB's INTELLECTUAL PROPERTY RIGHTS, to develop, make, have made, use, sell, offer for sale and import LICENSED COMPOUND, PRODUCT, and ANTI-CD20 ANTIBODY in the FIELD in the TERRITORY, subject to Section 5.2.2 and the other terms and conditions of this Agreement. The license granted under this Section 5.2.1 shall be (i) royalty-free, (ii) exclusive except as to SB and any authorized sublicensee of SB under Section 5.1.5 within the scope of such sublicense, and (iii) shall not be sublicenseable by Coulter without the consent of SB, except to AFFILIATES of Coulter, and only for so long as such AFFILIATES remain AFFILIATES. 5.2.2 The license to Coulter set forth in Section 5.2.1 shall be exercisable by Coulter only with respect to: (a) the development and manufacture (including THIRD PARTY manufacture for Coulter) of LICENSED COMPOUND, PRODUCT and SECOND GENERATION COMPOUND CANDIDATES to the extent set forth in Section 4.2, for use in the FIELD throughout the TERRITORY, and [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 39. 53 (b) the CO-PROMOTION of the PRODUCT in the FIELD in TERRITORY A, and (c) otherwise to comply with its obligations under this Agreement, and (d) in the case of SB KNOW-HOW, only to the extent such SB KNOW-HOW has been described to Coulter under this Agreement. 5.2.3 As used in Section 5.2.1, a license that is "exclusive except as to SB and any authorized sublicensee of SB under Section 5.1.5" means that SB shall not grant any other entity (except such a sublicensee acting within the scope of such sublicense) any license under SB's INTELLECTUAL PROPERTY RIGHTS in the FIELD (except as otherwise provided in Section 11.4.3), but that otherwise SB retains all of its rights of ownership in such licensed rights, including without limitation, the right to practice such property rights, subject only to the license granted. 5.2.4 The license granted to Coulter herein expressly excludes any license under SB technology for the [*]. SB agrees, however, that during the term of this Agreement it will not grant licenses to THIRD PARTIES for [*] ANTI-CD20 ANTIBODIES without the prior written consent of Coulter. 5.2.5 SB hereby grants to Coulter an exclusive, royalty-free license, with a right to sublicense, under SB's INTELLECTUAL PROPERTY RIGHTS, to develop, make, have made, use, import, market, offer for sale and sell PRODUCT or LICENSED COMPOUND in the FIELD in Japan. 5.2.6 Unless otherwise provided in this Agreement, Coulter covenants that it shall not, nor shall it cause any AFFILIATE to knowingly, use or practice directly or indirectly any INTELLECTUAL PROPERTY RIGHTS of SB for any purposes other than those set forth in Sections 5.2.1, 5.2.2 and 5.2.5. 5.3 NEW THIRD PARTY LICENSES. 5.3.1 DETERMINATION REGARDING NEED FOR NEW THIRD PARTY LICENSE. In the event either Coulter or SB believes that one or more licenses under intellectual property held by a THIRD PARTY are necessary or desirable in order to manufacture or develop or commercialize the PRODUCT anywhere in the TERRITORY, or otherwise assure that their activities under this Agreement do not infringe the intellectual property rights of such THIRD PARTY, then the Parties will discuss the situation in good faith. In the event that the Parties cannot make a unanimous decision regarding whether or not a license is necessary or desirable, the Parties shall submit such issue promptly thereafter to an UNAFFILIATED EXPERT who is a patent attorney. The expenses of engaging such UNAFFILIATED EXPERT patent attorney for such determination shall be shared equally by the Parties. If such UNAFFILIATED EXPERT patent attorney determines that a license is needed, the determination shall be binding on the Parties and Section 5.3.3(b) or 5.3.3(c) shall be applicable. 5.3.2 PROCEDURE FOR OBTAINING. Once a determination has been made, in accordance with Section 5.3.1, that one or more licenses under intellectual property held by a THIRD PARTY are necessary or desirable in order to manufacture or develop or commercialize the [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 40. 54 PRODUCT anywhere in the TERRITORY, or otherwise assure that their activities under this Agreement do not infringe the intellectual property rights of such THIRD PARTY, the appropriate Party (i.e., Coulter for TERRITORY A and SB for the NON-USA TERRITORY) will seek to obtain a license to such intellectual property (a "NEW THIRD PARTY LICENSE"). In the event such NEW THIRD PARTY LICENSE imposes costs on the Party who is not obtaining the license pursuant to Section 5.3.3 (i.e., SB for TERRITORY A and Coulter for the NON-USA TERRITORY), the economic terms of such license [*] and such approved terms shall be included within the NEW THIRD PARTY LICENSE COSTS. Should the Parties [*], then [*] to [*] the issue shall be presented to the [*] and the [*]. In the event that the [*] and the [*] are [*] on the issue, then [*] the decision regarding such economic terms provided, however, that, [*] shall not enter into any NEW THIRD PARTY LICENSE which [*] during the term of the guarantee set forth in Section 7.2.5. 5.3.3 NEW THIRD PARTY LICENSE COSTS. (a) The NEW THIRD PARTY LICENSE COSTS in TERRITORY A will be included as an element of COST OF GOODS as outlined in Section 1.11(c). (b) In the event that the JDC (or an UNAFFILIATED EXPERT under Section 5.3.1) determines that, in the absence of a NEW THIRD PARTY LICENSE, SB would be blocked from making, using or selling the PRODUCT in the NON-USA TERRITORY, then the NEW THIRD PARTY LICENSE COSTS for such NON-USA TERRITORY license will be [*]. (c) In the event that the JDC (or an UNAFFILIATED EXPERT under Section 5.3.1) determines that, in the absence of a NEW THIRD PARTY LICENSE, SB would not be blocked from making, using or selling the PRODUCT in the NON-USA TERRITORY, then SB shall have the right, at its discretion, to enter in any such NEW THIRD PARTY LICENSE, provided that any NEW THIRD PARTY LICENSE COSTS for such license will be borne entirely by SB. (d) "NEW THIRD PARTY LICENSE COSTS" shall mean any amounts paid to a THIRD PARTY licensor under a given NEW THIRD PARTY LICENSE. All NEW THIRD PARTY LICENSE COSTS [*] under Section 5.3.3(a) or 5.3.3(b) shall be approved in accordance with Section 5.3.2. 5.3.4 UPSTREAM LICENSES. It is understood that the licenses granted under this Article 5 anticipate sublicenses of technology licensed from THIRD PARTIES by Coulter to SB or by SB to Coulter, pursuant to license agreements in effect as of the Effective Date and/or NEW THIRD PARTY LICENSES (collectively, the "Upstream Licenses"). All such sublicenses granted hereunder are subject to the terms and conditions, including provisions regarding exclusivity, of any such Upstream Licenses. Each Party will [*] this Agreement for any relevant Upstream Licenses obtained after the Effective Date (within the scope of such new Upstream Licenses). [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 41. 55 5.4 EXCLUSIVITY. 5.4.1 (a) In the event SB or an SB AFFILIATE files a BLA in TERRITORY A or a MAA or [*] in a MAJOR MARKET COUNTRY for a MAJOR INDICATION for a Competitive Product (as defined in Section 5.4.3) or commences marketing a Competitive Product for a MAJOR INDICATION in TERRITORY A or a MAJOR MARKET COUNTRY, SB shall immediately notify Coulter. At any time thereafter, Coulter may, upon [*] prior written notice to SB, either (i) terminate the licenses contained in this Article 5 for those countries of TERRITORY A or MAJOR MARKET COUNTRIES in which SB or an SB AFFILIATE has filed a BLA or a MAA or an [*] for a MAJOR INDICATION for a Competitive Product or has commenced marketing a Competitive Product for a MAJOR INDICATION, provided, however, that if one of the MAJOR MARKET COUNTRIES in which such regulatory or marketing events occurred is in the European Union, then such termination shall be effective for the entire European Union; and/or (ii) convert the licenses contained in this Article 5 in any such country or countries to non-exclusive licenses. Upon termination pursuant to clause (i), the terms of Section 13.4 shall apply. Upon conversion to non-exclusive rights pursuant to clause (ii), the terms of Section 13.5 shall apply. In the event of a termination of the license in TERRITORY A or MAJOR MARKET COUNTRIES pursuant to clause (i), Coulter will thereafter have no obligation to make any payments to SB with respect to PRODUCT in TERRITORY A or MAJOR MARKET COUNTRIES under this Agreement. Notwithstanding the foregoing, Coulter will not exercise the option set forth in the second sentence of this Section 5.4.1(a) if: (i) the BLA in TERRITORY A or a MAA or [*] in a MAJOR MARKET COUNTRY for the Competitive Product is not for a MAJOR INDICATION; (ii) the Competitive Product is not being commercialized for treatment of any MAJOR INDICATIONS; (iii) with respect to TERRITORY A, neither Party is then utilizing any sales representatives to support PRODUCT in TERRITORY A in accordance with a JCC determination under Section 7.1.6(a) that such sales effort is not desirable; or (iv) with respect to either TERRITORY A or a MAJOR MARKET COUNTRY, ten (10) years have passed since the date of commercial launch of PRODUCT in the relevant country. (b) In the event Coulter or a Coulter AFFILIATE files a BLA in TERRITORY A for a MAJOR INDICATION for a Competitive Product or commences marketing a Competitive Product for a MAJOR INDICATION in TERRITORY A, Coulter shall immediately notify SB. At any time thereafter, SB may, upon six (6) months prior written notice to Coulter, terminate Coulter's right to CO-PROMOTE PRODUCT in TERRITORY A, and SB will thereafter have no obligation to make any payments to Coulter with respect to PRODUCT in TERRITORY A under this Agreement. Notwithstanding the foregoing, SB will not exercise the option set forth in the second sentence of this Section 5.4.1(b) if: [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 42. 56 (i) the BLA for the Competitive Product is not for a MAJOR INDICATION; (ii) the Competitive Product is not being commercialized for treatment of any MAJOR INDICATION; (iii) neither Party is then utilizing any sales representatives to support PRODUCT in TERRITORY A in accordance with a JCC determination under Section 7.1.6(a) that such sales effort is not desirable; or (iv) ten (10) years have passed since the date of commercial launch of PRODUCT in TERRITORY A. 5.4.2 (a) In the event that SB shall be acquired by or merge with a THIRD PARTY who is commercializing a Competitive Product at the time of such acquisition or merger in TERRITORY A or in a MAJOR MARKET COUNTRY for a MAJOR INDICATION, or in the event that SB acquires a THIRD PARTY who is commercializing a Competitive Product at the time of such acquisition in TERRITORY A or in a MAJOR MARKET COUNTRY for a MAJOR INDICATION, the Parties shall promptly meet to discuss, in good faith, an equitable resolution to such situation. In the event the Parties are unable, despite good faith efforts, to reach an equitable resolution to such situation within [*] to discuss the situation and SB has not, within [*] of the [*] either granted an exclusive license to a THIRD PARTY to make, use and sell such Competitive Product in TERRITORY A and the MAJOR MARKET COUNTRIES for all MAJOR INDICATIONS or otherwise transferred to a THIRD PARTY the exclusive right to make, use and sell such Competitive Product in TERRITORY A and the MAJOR MARKET COUNTRIES for all MAJOR INDICATIONS, Coulter may at any time thereafter, either (i) terminate the licenses contained in this Article 5 for those countries of TERRITORY A or MAJOR MARKET COUNTRIES for which SB has not taken the actions described in the preceding sentence (or for the entire European Union, if the Competitive Product is on the market in any MAJOR MARKET COUNTRY of the European Union); and/or (ii) convert the licenses contained in this Article 5 in any such country or countries to non-exclusive licenses. Upon termination pursuant to clause (i), the terms of Section 13.4 shall apply. Upon conversion to non-exclusive rights pursuant to clause (ii), the terms of Section 13.5 shall apply. In the event of a termination of the license in TERRITORY A or MAJOR MARKET COUNTRIES pursuant to clause (i), Coulter will thereafter have no obligation to make any payments to SB with respect to PRODUCT in TERRITORY A or MAJOR MARKET COUNTRIES under this Agreement. Notwithstanding the foregoing, Coulter will not exercise the option set forth in the second sentence of this Section 5.4.2(a) if: (i) the Competitive Product obtained by SB as a result of such acquisition or merger is not being commercialized for treatment of any MAJOR INDICATIONS; (ii) with respect to TERRITORY A, neither Party is then utilizing any sales representatives to support PRODUCT in TERRITORY A in accordance with a JCC determination under Section 7.1.6(a) that such sales effort is not desirable; or [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 43. 57 (iii) with respect to either TERRITORY A or a MAJOR MARKET COUNTRY, ten (10) years have passed since the date of commercial launch of PRODUCT in the relevant country. (b) In the event that Coulter shall be acquired by or merge with a THIRD PARTY who is commercializing a Competitive Product at the time of such acquisition or merger in TERRITORY A for a MAJOR INDICATION, or in the event that Coulter acquires a THIRD PARTY who is commercializing a Competitive Product at the time of such acquisition in TERRITORY A for a MAJOR INDICATION, the Parties shall promptly meet to discuss, in good faith, an equitable resolution to such situation. In the event the Parties are unable, despite good faith efforts, to reach an equitable resolution to such situation within [*] of their first meeting to discuss the situation and Coulter has not, within [*] of the end of such [*] either granted an exclusive license to a THIRD PARTY to make, use and sell such Competitive Product in TERRITORY A for all MAJOR INDICATIONS or otherwise transferred to a THIRD PARTY the exclusive right to make, use and sell such Competitive Product in TERRITORY A and the MAJOR MARKET COUNTRIES for all MAJOR INDICATIONS, SB may at any time thereafter, upon written notice to Coulter, terminate Coulter's right to CO-PROMOTE PRODUCT in TERRITORY A, and SB will thereafter have no obligation to make any payments to Coulter with respect to PRODUCT in TERRITORY A under this Agreement. Notwithstanding the foregoing, SB will not exercise the option set forth in the preceding sentence with respect to such Competitive Product if: (i) the Competitive Product obtained by Coulter as a result of such acquisition or merger is not being commercialized for treatment of any MAJOR INDICATIONS; (ii) neither Party is then utilizing any sales representatives to support PRODUCT in TERRITORY A in accordance with a JCC determination under Section 7.1.6(a) that such sales effort is not desirable; or (iii) ten (10) years have passed since the date of commercial launch of PRODUCT in TERRITORY A. 5.4.3 For purposes of this Section 5.4, "Competitive Product" shall mean any product, other than a PRODUCT, LICENSED COMPOUND or a SECOND GENERATION LICENSED COMPOUND CANDIDATE which is an ANTI-CD20 ANTIBODY. 5.4.4 For the avoidance of doubt, Section 5.4 shall not be applicable to a Party, an AFFILIATE of a Party or any licensee of a Party with respect to making, having made, using, selling, importing, or offering for sale any product which is not an ANTI-CD20 ANTIBODY. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 44. 58 ARTICLE 6 CONSIDERATION TO COULTER 6.1 UPFRONT FEES. 6.1.1 In consideration for the license under Coulter's INTELLECTUAL PROPERTY RIGHTS granted to SB under this Agreement, SB shall pay to Coulter Thirty Four Million Two Hundred Fifty Thousand U.S. Dollars (U.S. $34,250,000) in cash within five (5) business days after the Effective Date. 6.1.2 (a) In connection with this Agreement, SB shall pay to Coulter Seven Million Two Hundred Fifty Thousand U.S. Dollars (U.S. $7,250,000), within five (5) business days after the Effective Date, for the purchase of Common Stock of Coulter pursuant to a STOCK PURCHASE AGREEMENT, to be entered into simultaneous with the execution of this Agreement. Such stock purchase is more fully described in the STOCK PURCHASE AGREEMENT. (b) In further consideration for the license under Coulter's INTELLECTUAL PROPERTY RIGHTS granted to SB under this Agreement, SB shall make available a loan to Coulter of Fifteen Million U.S. Dollars (U.S. $15,000,000), within five (5) business days after the Effective Date pursuant to a LOAN AND SECURITY AGREEMENT, to be entered into simultaneously with the execution of this Agreement. Such loan is more fully described in the LOAN AND SECURITY AGREEMENT. 6.1.3 All amounts paid under Sections 6.1.1 and 6.1.2(a) shall be non-refundable and non-creditable, provided, however, in the event of termination of this Agreement by SB due to material breach by Coulter, the foregoing shall not preclude SB from seeking whatever damages are available at law. 6.2 MILESTONE PAYMENTS ON BEXXAR. In consideration for the rights granted hereunder with respect to BEXXAR, SB shall pay to Coulter the following amounts in cash within twenty (20) days after the following events occur with respect to BEXXAR (in its unconjugated and radiolabeled form) in the applicable territories:
TERRITORY A MILESTONE EVENTS -------------------------------------------------------------------------------- MILESTONE EVENT AMOUNT -------------------------------------------------------------------------------- Acceptance of all BLAs necessary for commercialization of BEXXAR $[*] for the first MAJOR INDICATION in TERRITORY A. REGULATORY APPROVAL of BEXXAR in TERRITORY A for FIRST $[*] INDICATION.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 45. 59 REGULATORY APPROVAL of BEXXAR in TERRITORY A for SECOND $[*] INDICATION. REGULATORY APPROVAL of BEXXAR in TERRITORY A for THIRD $[*] INDICATION. Sub-Total for TERRITORY A $[*]
TERRITORY B MILESTONE EVENTS -------------------------------------------------------------------------------- MILESTONE EVENT AMOUNT -------------------------------------------------------------------------------- Filing of all MAAs necessary for commercialization of $[*] BEXXAR for the first MAJOR INDICATION in the European Community. REGULATORY APPROVAL in the [*] for FIRST INDICATION $[*] (Subject to [*], [*] REGULATORY APPROVAL is received in such country; [*]). Selection of EUROPEAN FACILITY (as defined in Section $[*] 9.10.1) for BEXXAR. Payment to be made according to the payment schedule set forth in Section 9.10.5(a) and (b) REGULATORY APPROVAL in the [*] for SECOND INDICATION ([*] $[*] for [*] such REGULATORY APPROVAL, [*] such approval is received in such country; [*]. REGULATORY APPROVAL in the [*] for THIRD INDICATION ([*] $[*] for [*] such REGULATORY APPROVAL, [*] such approval is received in such country; [*]). Acceptance of all [*] Applications necessary for $[*] commercialization of BEXXAR for a MAJOR INDICATION in [*]. REGULATORY APPROVAL of [*] Application in [*] for FIRST $[*] INDICATION. REGULATORY APPROVAL of [*] Application in [*] for SECOND $[*] INDICATION. REGULATORY APPROVAL of [*] Application in [*] for THIRD $[*] INDICATION. Outpatient [*] Guidelines (as defined in Section 6.2.1(b)) $[*] are in effect and [*] (as defined in Section [*]) [*] (the "Outpatient Milestone") The one (1) year anniversary of the Outpatient Milestone $[*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 46. 60 First calendar year in which NET SALES in [*] are in excess $[*] of [*]. Sub-Total for TERRITORY B $[*]
TERRITORY C MILESTONE EVENTS MILESTONE EVENT AMOUNT -------------------------------------------------------------------------------- Filing of all applications necessary for commercialization of $[*] BEXXAR for the first MAJOR INDICATION in the MAJOR MARKETS IN TERRITORY C ([*] for which such filing occurs, [*]). REGULATORY APPROVAL in TERRITORY C for the FIRST INDICATION ([*] for $[*] which such REGULATORY APPROVAL is received, [*] this milestone.). REGULATORY APPROVAL in TERRITORY C for the SECOND INDICATION [*] for $[*] which such REGULATORY APPROVAL is received, [*] this milestone.). REGULATORY APPROVAL in TERRITORY C for the THIRD INDICATION ([*] for $[*] which such REGULATORY APPROVAL is received, [*] this milestone.). Sub-Total for TERRITORY C $[*]
OTHER MILESTONE EVENTS MILESTONE EVENT AMOUNT -------------------------------------------------------------------------------- Initiation of the first Pivotal Study of BEXXAR in [*] (Study [*]) $[*] Initiation of the first study of BEXXAR in [*] (Study [*]) $[*] Initiation of the first Pivotal Study of BEXXAR in [*] (Study [*]) $[*] Subtotal for DEVELOPMENT Events $[*] TOTAL BEXXAR MILESTONE PAYMENTS $[*]
No payment shall be owed for a milestone which is not achieved and in no event shall the milestone payments made by SB to Coulter upon the occurrence of the milestone events set forth in the tables above in this Section 6.2 exceed the amounts set forth opposite the milestone events in such tables. In the event that REGULATORY APPROVAL of BEXXAR is granted concurrently for the FIRST INDICATION and the SECOND INDICATION in the FIELD in, respectively, (i) TERRITORY A, (ii) the [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 47. 61 [*], (iii) [*] or (iv) any of the first four MAJOR MARKETS IN TERRITORY C, then the applicable milestone payments set forth in this Section 6.2 for REGULATORY APPROVAL with regard to such FIRST INDICATION and SECOND INDICATION in the relevant geographic area shall both be due from SB to Coulter, and shall both be paid within the time frame provided in this Section 6.2 (and the next MAJOR INDICATION for which REGULATORY APPROVAL is granted in the relevant geographic area shall be, and shall trigger the milestone payment for, the THIRD INDICATION). 6.2.1 DEFINITIONS RELATING TO MILESTONE PAYMENTS. (a) "Acceptance of all BLAs necessary for commercialization of BEXXAR for the first MAJOR INDICATION in TERRITORY A" of a given BLA shall be deemed to have occurred upon the earlier of (i) written notice of acceptance from the FDA of all BLAs filed by or on behalf of Coulter or SB under this Agreement [*] or (ii) [*] of such BLA with the FDA, [*]. "Acceptance of all [*] Applications necessary for commercialization of BEXXAR for a MAJOR INDICATION in [*]" for a given [*] shall be deemed to have occurred upon the date of receipt of a letter from the [*] confirming that the [*] for BEXXAR for a MAJOR INDICATION filed by or on behalf of SB under this Agreement has [*]. (b) The term "Outpatient [*] Guidelines" shall mean that the [*]. (c) The term "Key [*] Cancer Centers" means the following entities: [*] CANCER CENTER [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] (d) The term MAJOR MARKETS IN TERRITORY C consists of the following countries: [*]. (e) The term "Initiation of a study of [*]" shall mean the date that the [*] in the first clinical study of [*] which study is being performed in accordance with the FD&C [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 48. 62 ACT and applicable regulations promulgated thereunder (including without limitation 21 CFR Part 312). (f) The term "Initiation of a Pivotal Study of [*]" shall mean the date that the [*] in the first pivotal clinical study of [*], which pivotal study is being performed in accordance with the FD&C ACT and applicable regulations promulgated thereunder (including without limitation 21 CFR Part 312). (g) The term "Initiation of a Pivotal Study of [*]" shall mean the date that the [*] in the first pivotal clinical study of [*], which pivotal study is being performed in accordance with the FD&C ACT and applicable regulations promulgated thereunder (including without limitation 21 CFR Part 312). In the event that one or more of the clinical trials defined in Sections 6.2.1(e), 6.2.1(f) or 6.2.1(g) are canceled, the Parties will substitute appropriate alternative clinical trial(s) therefor. Such alternative clinical trial(s) must be Cross-Territory Trial(s) or Territory A Trial(s) (each as defined in Section 3.2.3). 6.2.2 DELAY OF COMMERCIAL LAUNCH IN NON-USA TERRITORY. With respect to any milestone outlined in this Section 6.2 which is payable upon REGULATORY APPROVAL in any jurisdiction in the NON-USA TERRITORY, if at the time of such REGULATORY APPROVAL, SB gives notice to Coulter that commercial launch will be delayed in such jurisdiction due to manufacture and supply problems beyond SB's reasonable control, then the milestone relating to the receipt of REGULATORY APPROVAL for such jurisdiction will not be due and payable until first commercial sale of BEXXAR in such territory. 6.2.3 NON-REFUNDABLE AND NON-CREDITABLE MILESTONE PAYMENTS. All amounts paid under this Section 6.2 shall be non-refundable and non-creditable, provided, however, in the event of termination of this Agreement by SB due to material breach by Coulter, the foregoing shall not preclude SB from seeking whatever damages are available at law. 6.2.4 OFFSET AGAINST MILESTONE PAYMENT FOR REGULATORY APPROVAL IN TERRITORY B. The Parties acknowledge and agree that in [*] there may be costs incurred with regard to PRODUCT due to the need for special warehousing of radiolabeled materials and/or the use of qualified nuclear medicine personnel, both as required by regulatory authorities. In the event that such special warehousing and use of nuclear medicine personnel are required by the applicable regulatory authorities in [*] and SB determines that it will incur the additional costs for such special warehousing and/or the use of nuclear medicine personnel, then the Parties agree that [*] of such actual costs in [*] shall be offset against the milestone payment owed by SB to Coulter under Section 6.2 for REGULATORY APPROVAL in the [*] for a FIRST INDICATION in the FIELD. Any amounts so offset shall be excluded from the determination of NON-USA COGS. 6.3 MILESTONE PAYMENTS ON PRODUCTS CONTAINING SECOND GENERATION LICENSED Compounds. In the event SB sends Coulter an SB OPTION EXERCISE NOTICE as set forth in Section 4.2.2 with respect to a SECOND GENERATION LICENSED COMPOUND, SB shall pay to [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 49. 63 Coulter the following amounts in cash within twenty (20) days after the first achievement of each of the following events:
MILESTONE EVENT AMOUNT ----------------------------------------------------------------------------- Acceptance of BLA in TERRITORY A for the first [*] Second $[*] Generation Product. Filing of MAA in European Community for the first [*] $[*] Second Generation Product REGULATORY APPROVAL of BLA in TERRITORY A for the first $[*] [*] Second Generation Product. REGULATORY APPROVAL of MAA in the first MAJOR MARKET $[*] COUNTRY in the European Community for the first [*] Second Generation Product. Acceptance of BLA in TERRITORY A for the first [*] Second $[*] Generation Product. Filing of MAA in European Community for the first [*] $[*] Second Generation Product. REGULATORY APPROVAL of BLA in TERRITORY A for the first $[*] [*] Second Generation Product. REGULATORY APPROVAL of MAA in the first MAJOR MARKET $[*] COUNTRY in the European Community for the first [*] Second Generation Product.
"Second Generation Product" shall mean a PRODUCT containing a SECOND GENERATION LICENSED COMPOUND. Each of the foregoing milestones shall be payable only once under this Agreement, regardless of the number of [*] Second Generation Products for which SB exercises its option and no payment shall be owed for a milestone which is not achieved. All amounts paid under this Section 6.3 shall be non-refundable and non-creditable, provided, however, in the event of termination of this Agreement by SB due to material breach by Coulter, the foregoing shall not preclude SB from seeking whatever damages are available at law. Notwithstanding the above, or any other provision of this Agreement, in no event shall SB owe Coulter any milestone payment under this Section 6.3 for the achievement of any of the foregoing milestones by a SECOND GENERATION LICENSED COMPOUND for which Coulter fails to provide the Coulter Funding Option Exercise Notice (defined in Section 4.2.4(b)) on or before the Coulter Funding Option Termination Date (defined in Section 4.2.4(b)). 6.4 SECTION 9.10.5 MILESTONE. The milestone payments outlined in Section 9.10.5 related to the selection of a EUROPEAN FACILITY (as defined in Section 9.10.1) for BEXXAR by SB shall be paid in accordance with the provisions of such Section. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 50. 64 6.5 METHOD OF MAKING MILESTONE PAYMENTS. All payments to be made to Coulter under Sections 6.1, 6.2, 6.3 and 6.4 shall be made by SB to Coulter by way of wire transfer to such account as Coulter shall designate before such payment is due. 6.6 ROYALTIES AND PROFIT SHARING. SB shall, in addition to the payments set forth above, also pay to Coulter royalties and such other amounts as set forth in Article 7. 6.7 [*] RIGHTS. If for any reason, SB determines, in good faith, that BEXXAR will not be able to be [*] on or before [*], SB shall have the right to [*] with respect to [*] and to substitute in its [*] under this Agreement [*] (the [*]), all subject to the terms and conditions of this Section 6.7. The term [*] as used in this Section means any [*], including without limitation, any [*] as well as any [*], including without limitation, any [*] of any [*] any [*] of any [*] any [*], any [*] of any [*], any [*] of any [*]; or any [*]. The [*] may be [*] by SB from [*] which: (i) are owned or [*] as of the [*] (as defined below); (ii) may be [*] the [*] as shown by, at least, [*]; and (iii) Coulter has not [*] in [*] as of the [*] or is not otherwise engaged as of such [*] in advanced [*] related to [*] in [*] by Coulter to such [*] as proven by written documentation (e.g., a non-binding letter of intent with respect to the [*] by [*] or other similar written evidence). The date that SB provides written notice to Coulter of SB's determination under this Section 6.7 shall be the [*]. Within [*] after receipt of such notice, Coulter shall provide to SB [*] the [*] together with the essential information available to Coulter regarding [*]. If requested by SB, Coulter shall meet with SB as soon as possible to [*] and provide such further information as SB may request and Coulter possesses. In any event, if SB desires to proceed with the exercise of its rights under this Section 6.7, SB shall [*] and provide notice of such [*] within [*] from Coulter of [*] and essential information available to Coulter regarding [*] such [*] (the [*] being referred to herein as the [*]). Such [*] shall [*] of [*] by [*] of the [*] and the terms of Section 13.4 of this Agreement shall be applicable with respect to such [*]. Promptly following such [*], the Parties shall meet to negotiate in good faith [*] to [*] and [*] with respect to the [*], such [*] within [*] the [*]. The principles of the agreement with respect to the [*] shall be (i) [*] shall be required of SB; (ii) [*] and [*] in [*] related to the [*] shall be [*]; (iii) in [*], SB and Coulter shall [*] and [*] as provided in this Agreement; and (iv) SB shall not be responsible for [*] with respect to such [*] which have been previously paid with respect to [*], but as to any such [*] which have not been paid, SB shall [*] for the [*] of the same [*] provided for under this Agreement in the event the [*] is [*] in [*] existed as of the [*], and subject to a [*] in the event that the [*] is of [*], respectively, and based on the same events [*] (with the Parties to agree [*] to the extent such [*]. All aspects of this Section 6.7 shall be subject to any [*] that [*] to the [*]. The Parties agree that (a) between the [*] and the [*] which [*] of [*] under this Section 6.7, Coulter shall not [*] regarding [*] of the [*] that are on the [*] and (b) [*] the [*] which [*] of [*] under this Section 6.7, SB shall have no further claim to [*], if [*] hereunder, the [*] by [*] the [*]. The Parties further agree that between the [*] and [*] the Parties mutually agree that they will [*] the [*] and [*] for the [*], or (y) [*] the [*] if for any reason the Parties have failed to [*] the [*] and [*] for the [*]. Coulter shall not enter into [*] with [*] regarding the rights to such [*] prior to [*] in the event that [*] has [*] to [*] (ii) the failure by SB to [*] within the time periods specified above, or (iii) [*] after the [*] if for any reason the Parties have failed to [*] the [*] and [*] of the [*]. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 51. 65 ARTICLE 7 MARKETING 7.1 CO-PROMOTION IN TERRITORY A. 7.1.1 RIGHTS TO CO-PROMOTE. With respect to the commercialization of the PRODUCT in TERRITORY A, Coulter and SB shall have the right to CO-PROMOTE the PRODUCT during the TERM OF CO-PROMOTION. Notwithstanding the foregoing, in no event shall Coulter have responsibility to CO-PROMOTE the PRODUCT in the Commonwealth of Puerto Rico or any territories or possessions of the United States. 7.1.2 LEAD PARTY FOR COMMERCIALIZATION IN TERRITORY A. SB shall be the lead Party for implementation of, and shall make tactical decisions with regard to, CO-PROMOTION in TERRITORY A, consistent with the terms of this Agreement, the then current JOINT MARKETING PLAN and any prior direction provided by the JCC. 7.1.3 JOINT MARKETING PLAN. (a) PURPOSE OF THE JOINT MARKETING PLAN. The CO-PROMOTION of the PRODUCT will be governed by a "JOINT MARKETING PLAN" which will be in a form consistent with SB's marketing planning process (in terms of both timetable and required documentation, i.e., PRODUCT strategy plans and annual tactical plans), the current format of which is attached hereto as Exhibit G, and with the terms of this Article 7. The JOINT MARKETING Plan will take into consideration factors such as market conditions, regulatory factors and competition and the respective COMMERCIALLY REASONABLE EFFORTS of each Party. Such JOINT MARKETING PLAN will attempt, to the extent practicable, to describe the proposed plan for commercialization of the PRODUCT in the USA, including overall marketing strategy, budget, operating guidelines (if any), market and sales forecasts, pricing analysis and estimated launch date, guidelines for discounting the PRODUCT, as well as advertising and other promotional materials to be developed and used during the CO-PROMOTION. (b) PREPARATION, APPROVAL AND MONITORING OF JOINT MARKETING PLAN. A draft of the initial JOINT MARKETING PLAN will be developed and approved by the JCC no later than ninety (90) days after the Effective Date. Thereafter, an updated JOINT MARKETING PLAN will be developed and approved by the JCC at such times as the JCC deems appropriate, but no less frequently than annually. SB shall take the lead in preparing the JOINT MARKETING PLAN and each update thereto in accordance with Section 7.1.6(b)(ii). The JCC will monitor implementation of the initial JOINT MARKETING PLAN and each update thereto. 7.1.4 PRODUCT TEAM. In the interest of facilitating the implementation of CO-PROMOTION in TERRITORY A, no later than thirty (30) days after the Effective Date, the Parties shall form a "Product Team" composed of both SB and Coulter personnel. Each member of the Product Team shall participate as an equal member, provided that the Product Team shall be chaired by the BEXXAR Product Manager from SB who shall provide direction and oversight with respect to the implementation of the then current JOINT MARKETING PLAN and associated tactics [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 52. 66 and programs. The Product Team shall develop objectives, strategies and associated budgets for the implementation of the responsibilities indicated in Exhibit F-1 in accordance with the then current JOINT MARKETING PLAN and SB's marketing planning process. Coordination and updates should occur routinely between the Product Team members. To facilitate the functioning of the Product Team, each Party shall provide, promptly after the Effective Date and on an ongoing basis throughout the term of the Agreement, all clinical, marketing, and other related and necessary information that becomes available to such Party which may be needed for the Product Team to function, provided that such information shall be subject to the confidentiality requirements set forth in Article 17. Each Party shall bear all travel and living expenses incurred by its employees as a result of their participation in any of the meetings outlined in this Section and such expenses shall not be included in the calculation of the JOINT P&L outlined in Section 7.1.14. 7.1.5 PRODUCT PRICING. [*] PRODUCT pricing in TERRITORY A, including discounting. Should [*] become [*] the issue of pricing, [*] shall be handled according to the procedures set forth under Section 2.2.2. 7.1.6 EFFORTS OF THE PARTIES. (a) SALES EFFORTS. Coulter and SB shall each use COMMERCIALLY REASONABLE EFFORTS to CO-PROMOTE the PRODUCT in TERRITORY A pursuant to the terms and conditions hereof. The JCC will agree upon and monitor each Party's SALES EFFORT (as defined below) for each Co-promotion Year during the TERM OF CO-PROMOTION. "Co-promotion Year" shall mean, for the calendar year in which the Parties are first engaged in CO-PROMOTION, the portion of the calendar year remaining beginning upon the date of the FIRST COMMERCIAL SALE of the PRODUCT in TERRITORY A, and shall mean the relevant January 1 through December 31 calendar year, or pro rata portion thereof, for all subsequent calendar years during the TERM OF CO-PROMOTION. "SALES EFFORT" shall mean FTES who [*] to [*] with [*] in TERRITORY A, in accordance with the then current JOINT MARKETING PLAN, provided such [*] in an [*] and [*], including without limitation, [*]. The Parties agree, as of the Effective Date, that in the first Co-promotion Year Coulter will provide at least [*] FTES of SALES EFFORT in connection with the CO-PROMOTION and SB shall provide at least [*] FTES of SALES EFFORT in connection with the CO-PROMOTION. The number of FTES of SALES EFFORT to be provided by each Party during each Co-Promotion Year shall be determined by the JCC no later than [*] to the [*] of each subsequent Co-promotion Year, provided that Coulter may provide at least [*] of such total SALES EFFORT during each Co-Promotion Year. The JCC shall base its determination of the level of SALES EFFORT provided by a Party on an FTE basis where, for example, one sales representative spending [*] of his or her time on Product detailing is equal to [*], and one sales representative spending [*] of his or her time on PRODUCT detailing is equal to [*]. During any Co-Promotion Year, each Party shall use its good faith efforts to deliver at least [*] of the number of FTES of SALES EFFORT to be provided by such Party during each Co-Promotion Year as determined by the JCC ("Minimum Sales Effort"). During any Co-Promotion Year in which a Party [*], such Party [*] other Party [*] for each FTE (or the pro rata portion thereof for each part FTE) for which [*] the [*]. By way of illustration, if the number of FTES of SALES EFFORT to be provided by a Party [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 53. 67 during a Co-Promotion Year as determined by the JCC was [*] and the number of FTES of SALES EFFORT [*], such Party [*] Party [*] according to the following: (i) the [*] to be delivered by the Party during such Co-Promotion Year would be [*] (i.e., [*]); and (ii) [*] ([*]) [*] 1. FTE multiplied by [*]. (b) ALLOCATION OF SALES AND MARKETING RESPONSIBILITIES. (i) SALES RESPONSIBILITIES. It is expected, as of the Effective Date, that (i) the Coulter Sales Effort personnel will take the lead on [*] and (ii) the SB Sales Effort personnel will take the lead on [*] not detailed by Coulter under clause (i) above. It is further understood that the fact that the JCC decides that one Party's Sales Effort personnel takes the lead with respect to a particular target audience does not preclude the other Party's Sales Effort personnel from detailing such target audience or from otherwise providing input with respect to the lead Party's activities, provided that such is in accordance with the then current JOINT MARKETING PLAN. (ii) MARKETING RESPONSIBILITIES. Each Party will contribute the expertise and undertake the activities set forth under its name on Exhibit F-2, in accordance with the then current JOINT MARKETING PLAN. It is understood that the JCC can reallocate the responsibilities among the Parties set forth on Exhibit F-2 as it deems appropriate and Exhibit F-2 will be updated accordingly. It is further understood that the fact that the JCC decides that one Party should contribute its expertise and undertake the activities set forth under its name on Exhibit F-2 does not preclude the other Party from contributing its expertise or undertaking such activities or from otherwise providing input with respect to the other Party's activities, provided that such is in accordance with the then current JOINT MARKETING PLAN. (c) COMPENSATION AND BONUS SYSTEM FOR SALES REPRESENTATIVES. The Parties acknowledge that in order to attract and retain professional pharmaceutical sales representatives, [*] SB's sales representatives and [*] Coulter's sales representatives. To ensure consistency of effort between the sales representatives of the Parties, each Party agrees that [*], each Party will [*], provided that each Party shall [*]. 7.1.7 COMPLIANCE WITH LAW. Each Party shall cause its sales force, and all other employees and approved agents and representatives, to comply with all applicable laws, regulations and guidelines in connection with the CO-PROMOTION of the PRODUCT, including, without limitation, the Prescription Drug Marketing Act and the Federal Anti-Kickback Statute. Each Party shall cause its sales force, in the course of its CO-PROMOTION of the PRODUCT, to (a) limit its claims of efficacy and safety for PRODUCT to those which are consistent with the JCC's then approved product circular for PRODUCT, (b) not delete or modify claims of efficacy and safety in the CO-PROMOTION of PRODUCT so that they are different in any way from those which are contained in the JCC's then approved product circular for PRODUCT, or make any changes in promotional materials and literature provided by the JCC, (c) conduct the CO-PROMOTION of PRODUCT in strict adherence to the American Medical Association Gifts to Physicians From [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 54. 68 Industry Guidelines, and (d) not knowingly or negligently do anything which will jeopardize the goodwill or reputation of PRODUCT. 7.1.8 PROMOTIONAL AND ADVERTISING MATERIALS. The Parties shall disseminate in TERRITORY A only those promotional and advertising materials which have been approved for use by the JCC, or the Product Team (defined in Section 7.1.4) for those items delegated to it. SB will propose the promotional and advertising materials to the Product Team and will be responsible for creating and procuring any promotional and advertising materials determined to be necessary or desirable by the Product Team. The cost of such materials shall be included in MARKETING COSTS. [*] of such promotional and advertising materials after review of such materials by both Parties, [*]. In the event [*] on an [*] such promotional and advertising materials, [*] to [*], the [*] if an [*]. In the event the [*] to [*] to [*]. All such materials shall be consistent with the JOINT MARKETING PLAN approved by the JCC and neither Party shall make any claims or representations in respect of the PRODUCT that have not been approved by the JCC. All such written and visual materials and all documentary information, promotional material, and oral presentations (where practical) regarding the promotion of the PRODUCT will display the SB and Coulter names and logos with equal prominence, to the extent permitted by applicable law. SB shall have the right to make the final decision regarding the selection of the advertising agency of record for the PRODUCT, provided that reasonably in advance of SB implementing such decision Coulter shall have the opportunity to participate in the selection process and to provide an opinion, and SB shall take any Coulter comments into serious consideration, but shall not be bound by them. 7.1.9 SAMPLES. Each of the Parties will keep accurate records as to the distribution of free clinical trial materials and samples of PRODUCTS in TERRITORY A, if any, provided that such distribution shall be strictly in accordance with the determinations of the JCC and JDC, as applicable, and the then current JOINT MARKETING PLAN and JOINT DEVELOPMENT PLAN, as applicable, and comply with all applicable laws, rules and regulations dealing with the distribution of such goods and samples. 7.1.10 ORDERS, DISTRIBUTION, COMPLETION OF SALES, RETURNS. Coulter will have responsibility in TERRITORY A for (i) [*]; and (iii) [*]. SB will have responsibility in TERRITORY A for [*]. The JCC shall determine whether [*], and in the event such functions cannot be performed effectively by [*]. SB shall make available to Coulter, in a format [*] to [*]. 7.1.11 EXCHANGE OF MARKETING INFORMATION. From time-to-time the JCC will develop call lists, schedules, and other appropriate information for the purpose of determining the physicians and other persons involved in the drug purchase decision-making process to whom Coulter and SB, respectively, may detail and otherwise promote each Product. To the extent legally permitted, the Parties agree to cooperate in finding an efficient, economical and expeditious way to provide a call list and other information indicating the identity of those physicians and other persons involved in the decision-making process regarding the purchase of pharmaceuticals. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 55. 69 7.1.12 CO-PROMOTION EXPENSES. (a) PRE-LAUNCH. Prior to commercial launch of PRODUCT in TERRITORY A, each Party will be allowed to allocate to the JOINT P&L calculated under Section 7.1.14 only OUT-OF-POCKET COSTS which are SALES COSTS, MARKETING COSTS, PATENT COSTS, TRADEMARK COSTS or OTHER OPERATING INCOME/EXPENSE, all subject to the prior approval of the JCC or in accordance with the then current JOINT MARKETING PLAN, except that Coulter shall also be allowed to allocate to the JOINT P&L an amount equal to [*] (i.e., [*]) for [*] the commercial launch of PRODUCT in TERRITORY A (such amount [*]), provided that such allocation shall not occur if the PRODUCT is not commercially launched in TERRITORY A, and such allocation shall be made only after the PRODUCT is commercially launched in TERRITORY A. (b) POST-LAUNCH. After the commercial launch of PRODUCT in TERRITORY A, those expenses outlined in Exhibit B-1 shall be allocated to the JOINT P&L calculated under Section 7.1.14. 7.1.13 ALLOCATION OF OPERATING PROFIT OR LOSS. In consideration for each Party's CO-PROMOTION efforts in TERRITORY A, for each calendar quarter, SB shall be entitled to fifty percent (50%) of the OPERATING PROFIT OR LOSS for such quarter and Coulter shall be entitled to fifty percent (50%) of the OPERATING PROFIT OR LOSS for such quarter, such amounts to be distributed to the Parties pursuant to Section 7.1.14. 7.1.14 JOINT P&L. Within one (1) month after the close of each calendar quarter, or earlier if possible, during the term of this Agreement (i.e., on or before the last day of each of the months of April, July, October and January), Coulter shall furnish to SB a statement setting forth its COST OF GOODS (subject to Sections 9.8.1, 9.8.2 and 9.9), MARKETING COSTS, SALES COSTS, OTHER OPERATING INCOME/EXPENSE, DISTRIBUTION COSTS (to the extent not covered in COST OF GOODS), PATENT COSTS and TRADEMARK COSTS (collectively, "Coulter Operating Expenses") for such quarter in TERRITORY A, as defined in Exhibit B-1, and all data on which the determination of such costs was calculated. Within two (2) months after the close of each calendar quarter, or earlier if possible, during the term of this Agreement (i.e., on or before the last day of each of the months of May, August, November and February), SB shall furnish to Coulter a statement (the "JOINT P&L") setting forth NET SALES in TERRITORY A during such quarter, SB's COST OF GOODS (subject to Sections 9.8.1, 9.8.2 and 9.9), MARKETING COSTS, SALES COSTS, OTHER OPERATING INCOME/EXPENSE, DISTRIBUTION COSTS (to the extent not covered in COST OF GOODS), PATENT COSTS and TRADEMARK COSTS (collectively, "SB Operating Expenses") for such quarter in TERRITORY A, as defined in Exhibit B-1, and all data, including Coulter Operating Expenses, on which the determination of OPERATING PROFIT OR LOSS for such quarter was calculated. Whenever SB provides Coulter with a statement of SB Operating Expenses, or Coulter provides SB with a statement of Coulter Operating Expenses, the providing Party shall include supporting documentation and promptly after request by the receiving Party, the supporting journal entries made in the disclosing Party's books of accounts. In the event OPERATING PROFIT OR LOSS for such quarter is a positive number, SB will submit to Coulter, with the JOINT P&L, an amount equal to (i) Coulter Operating Expenses for such quarter plus (ii) fifty percent (50%) of the OPERATING PROFIT OR LOSS for such quarter. In the event OPERATING PROFIT OR LOSS for such [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 56. 70 quarter is a negative number, either (a) SB will submit to Coulter, with the JOINT P&L an amount equal to Coulter Operating Expenses for such quarter less Coulter's fifty percent (50%) share of the OPERATING PROFIT OR LOSS for such quarter if Coulter's Operating Expenses for such quarter exceeded Coulter's fifty percent (50%) share of the OPERATING PROFIT OR Loss for such quarter, or (b) Coulter will submit to SB, within thirty (30) days after receiving the JOINT P&L an amount equal to Coulter's fifty percent (50%) share of the OPERATING PROFIT OR LOSS for such quarter less Coulter Operating Expenses for such quarter if Coulter's Operating Expenses for such quarter is less than Coulter's fifty percent (50%) share of the OPERATING PROFIT OR LOSS for such quarter. If the TERM OF CO-PROMOTION ends during an accounting quarter, the amounts due hereunder shall be calculated for such shortened calendar quarter. In the event that the foregoing procedure does not permit one or both of the Parties to comply with reporting requirements under applicable United States securities laws, rules and regulations, the JCC will modify the foregoing procedure to permit the Parties to comply with such reporting requirements, consistent with the general approach set forth in this Section 7.1.14. The JCC will have the authority to amend the method utilized for determining which expenses are included within COST OF GOODS, MARKETING COSTS, SALES COSTS, OTHER OPERATING INCOME/EXPENSE, DISTRIBUTION COSTS (to the extent not covered in COST OF GOODS), PATENT COSTS and TRADEMARK COSTS, as defined in Exhibit B-1 as of the Effective Date. 7.1.15 ELECTION TO FOREGO CO-PROMOTION RIGHT. It is Coulter's intent, at the time of execution of this Agreement, to participate in the CO-PROMOTION during the term of this Agreement. SB understands, however, that Coulter's corporate strategy may change over time. Accordingly, upon twelve (12) months prior written notice to SB, or such lesser period as approved by SB in writing, Coulter may elect to forego its right to participate in the CO-PROMOTION of the PRODUCT in TERRITORY A. Coulter may also lose its rights to CO-PROMOTE PRODUCT in TERRITORY A in accordance with the notice in that regard provided to Coulter by SB under Section 4.2.3, or in accordance with the notice provided by SB to Coulter under Section 5.4.1(b) or Section 5.4.2(b). In the event that Coulter loses its rights to CO-PROMOTE PRODUCT in TERRITORY A in accordance with Section 5.4.1(b), the terms and condition of Section 5.4.1(b) shall be applicable. In the event that Coulter loses its rights to CO-PROMOTE PRODUCT in TERRITORY A in accordance with Section 5.4.2(b), the terms and condition of Section 5.4.2(b) shall be applicable. In the event that Coulter loses its rights to CO-PROMOTE the PRODUCT in TERRITORY A in accordance with Section 4.2.3 or the third sentence of this Section 7.1.15, the Parties will promptly meet to negotiate, in good faith, appropriate amendment of this Agreement to reflect the fact that Coulter will no longer participate in the CO-PROMOTION of PRODUCT and such amendment shall include the payment from SB to Coulter of a commercially reasonable royalty rate on NET SALES of PRODUCT in TERRITORY A which occur after the effective date of such Coulter loss of its rights to CO-PROMOTE PRODUCT in TERRITORY A. It is agreed that such royalty rate shall be higher than the royalty rate to be paid on NET SALES of PRODUCT in TERRITORY B but less than the amount that Coulter would have received had it continued to CO-PROMOTE PRODUCT in TERRITORY A. In the event that the Parties cannot agree as to the appropriate royalty rate within four (4) months after the date that Coulter has lost its rights to CO-PROMOTE PRODUCT in TERRITORY A in accordance with Section 4.2.3 or the third sentence of this Section 7.1.15, the Parties shall submit such decision to the dispute resolution mechanism outlined in Section 18.5. As of the effective date on which Coulter has foregone its rights to CO-PROMOTE under the third [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 57. 71 sentence of this Section 7.1.15 or has lost its rights under Sections 4.2.3, 5.4.1(b) or 5.4.2(b), it shall have no further obligations relating to marketing or selling PRODUCT and shall also lose its rights to be reimbursed for any activities undertaken after such loss which are related to Coulter Operating Expenses (defined in Section 7.1.14) or to any share of the OPERATING PROFIT OR LOSS after such effective date, although Coulter will still be entitled to be reimbursed for DEVELOPMENT COSTS and MANUFACTURE DEVELOPMENT COSTS as provided in the Agreement. In the event that the Parties have not determined a commercially reasonable royalty rate as of the effective date of Coulter's loss of its right to Co-Promote PRODUCT in TERRITORY A in accordance with Section 4.2.3 or the third sentence of this Section 7.1.15, then until such time as such royalty rate has been determined by the Parties or by the procedure outlined in Section 18.5, SB shall pay Coulter a royalty of [*] of NET SALES of PRODUCT in TERRITORY A which occur after such effective date until the date of such royalty rate determination. The [*] royalty rate set forth in the preceding sentence shall not be used for evidentiary purposes under the procedure outlined in Section 18.5. If the Parties determine a commercially reasonable royalty rate, such rate shall be retroactive to the date of Coulter's loss of its rights to CO-PROMOTE PRODUCT in TERRITORY A, subject to any reconciliation for payments already made to Coulter by SB during such time period under this Section 7.1.15, including interest to Coulter for any underpayment by SB for such time period. 7.1.16 SALES TRAINING. (a) SB shall use its existing sales training department, infrastructure and process to lead in the development of training materials and programs and shall use such existing resources to execute and coordinate the overall sales training program for the PRODUCT. SB shall provide both SB's and Coulter's sales representatives (up to the target number for Coulter as determined by the JCC pursuant to Section 7.1.6(a)) with promotional training regarding the detailing and promotion of PRODUCT to target prescribers in TERRITORY A in accordance with the then current JOINT MARKETING PLAN, provided that such training shall be at the same level of product training as that which would be provided to SB's own sales representatives who have previous professional pharmaceutical sales experience. SB training of Coulter personnel shall be timed so as to enable Coulter's detailing efforts in support of PRODUCT to commence no later than the date provided in the then current JOINT MARKETING PLAN. (b) Coulter and SB shall revise SB training program materials as needed to develop PRODUCT-specific training program materials and, where Coulter and SB are unable to revise SB training program materials for such purpose, Coulter and SB shall develop new PRODUCT-specific training program materials as required. Specifically, it is expected that Coulter will develop training program materials regarding (i) non-Hodgkin's lymphoma (where such materials are not commercially available), (ii) the nuclear medicine aspects of the PRODUCT and (iii) the clinical aspects of the PRODUCT, including administration, treatment course and outcomes data. Coulter shall provide appropriate personnel where necessary to participate in the delivery of PRODUCT-specific training program materials in the sales training programs. (c) The Parties expect that during the CO-PROMOTION, their respective sales forces will receive PRODUCT training at formal meetings of all sales representatives of both [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 58. 72 Parties to be held approximately once or twice each year (each, a "National Meeting") and at more frequent informal meetings of groups of sales representatives composed of less than the entire sales force of both Parties (each, a "Regional Meeting"). Additionally, the Parties may choose to hold training activities at National Meetings relating both to the PRODUCT and to other products promoted by such sales representatives. The travel and subsistence expenses incurred by the attendees at such sales meetings shall be borne directly by the Parties and are excluded from the calculation of the JOINT P&L outlined in Section 7.1.14. (d) During the term of the Agreement, each Party shall train their sales representatives in TERRITORY A on the collection of data for the reporting of adverse drug experiences to regulatory authorities and regarding product-related inquiries and product complaints in TERRITORY A, in accordance, respectively, with the pharmacovigilance agreement attached to this Agreement as EXHIBIT H, the product inquiry process described on EXHIBIT I and the product complaint procedure that the Parties adopt pursuant to Section 7.4. 7.2 NON-USA TERRITORY. 7.2.1 GENERAL. SB will market and sell the PRODUCT in the NON-USA TERRITORY using COMMERCIALLY REASONABLE EFFORTS, subject to the diligence provisions set forth in Section 7.2.2. SB shall cause its sales force, and all other employees and approved agents and representatives, to comply with all applicable laws, regulations and guidelines in connection with the sale of the PRODUCT in the NON-USA TERRITORY. SB shall give Coulter an opportunity to review and comment upon the NON-USA MARKETING PLAN (when available, but in any event prior to implementation of such marketing plan), provided that while SB shall take such comments into serious consideration, SB shall not be bound by them. SB shall inform Coulter of any significant decisions made by SB or its permitted sublicensees regarding implementation of the NON-USA MARKETING PLAN sufficiently in advance of such implementation to enable Coulter to comment upon such decisions, and SB shall take such comments into serious consideration, but shall not be bound by them. 7.2.2 COMMERCIALIZATION MILESTONES. (a) In addition to the obligations set forth in Section 7.2.1, in each MAJOR MARKET COUNTRY in which SB receives REGULATORY APPROVAL for the FIRST INDICATION, SB will achieve FIRST COMMERCIAL SALE for the FIRST INDICATION [*] months of the date it receives such REGULATORY APPROVAL. Such time period will be extended if factors beyond SB's reasonable control (including without limitation, [*]) preclude FIRST COMMERCIAL SALE, but such extension shall last only for so long as such factors continue. In the event SB does not achieve such milestone in a given MAJOR MARKET COUNTRY by such date, as such may be extended under this Section 7.2.2(a), and is unable to convince Coulter to further extend such date, Coulter may elect to adjust the licenses granted by Coulter under Article 5 of this Agreement to (i) exclude such MAJOR MARKET COUNTRY from the TERRITORY or (ii) become non-exclusive in such MAJOR MARKET COUNTRY. In the event Coulter makes such election, it shall provide written notice to SB and, as of the date of such notice, the terms of Sections 13.4 or 13.5, as applicable, shall apply for such MAJOR MARKET COUNTRY. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 59. 73 (b) In the event that, in any calendar year following the third anniversary of the date of FIRST COMMERCIAL SALE in a MAJOR MARKET COUNTRY for the FIRST INDICATION, the royalty amount payable under Section 7.2.4(a) for a given calendar year is less than the Minimum Distribution Payment (as defined in Section 7.2.2(c)) for such MAJOR MARKET COUNTRY for such calendar year, SB may, within [*] of the end of such calendar year, pay Coulter the difference between the Minimum Distribution Payment for such MAJOR MARKET COUNTRY for such year (as determined in accordance with Section 7.2.2(c)) and the royalty amount payable under Section 7.2.4(a) for such year (the "Differential"). In the event SB elects not to pay the Differential for such MAJOR MARKET COUNTRY for such calendar year, SB shall explain the circumstances for the Differential to Coulter and Coulter shall consider such circumstances in good faith. Coulter may elect either to (i) terminate the licenses granted by Coulter under this Agreement for such MAJOR MARKET COUNTRY or (ii) adjust the licenses granted by Coulter under Article 5 of this Agreement to become non-exclusive for such MAJOR MARKET COUNTRY. Prior to Coulter making such election, the Parties may mutually agree to meet to discuss the percentage of RADIOLABELED ANTIBODY manufactured at the EUROPEAN FACILITY (as defined in Section 9.10.1) (if such EUROPEAN FACILITY is completed by SB and regulatory approval for such EUROPEAN FACILITY is granted to SB) that SB shall make available to Coulter in the event Coulter makes the election under clause (ii) above and the commercially reasonable prices at which such RADIOLABELED ANTIBODY would be made available to Coulter. If the Parties are unable to agree upon the terms under which SB would supply RADIOLABELED ANTIBODY to Coulter, Coulter shall make the election set forth above regarding the termination or non-exclusivity in such countries of the licenses granted by Coulter under Article 5 of this Agreement. In the event Coulter makes the election in clause (i), it shall provide written notice to SB and, as of the date of such notice, the terms of Section 13.4 shall apply with regard to such MAJOR MARKET COUNTRY. In the event Coulter makes the election in clause (ii), it shall provide written notice to SB and, as of the date of such notice, the terms of Section 13.5 shall apply for such MAJOR MARKET COUNTRY. In the event Coulter makes the election in clause (ii) and grants a non-exclusive license to a THIRD PARTY to sell PRODUCT in such MAJOR MARKET COUNTRY [*] are [*]. (c) A separate "Minimum Distribution Payment" will be calculated for each MAJOR MARKET COUNTRY for each applicable calendar year (i.e., each calendar year following the third anniversary of the date of FIRST COMMERCIAL SALE in such country) and will equal A times B times C, where: A = [*]; and B = [*]; and C = [*] provided that (i) [*]; and (ii) [*] at [*] [*] in [*]. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 60. 74 7.2.3 THIRD PARTY DISTRIBUTION AGREEMENTS. (a) SB may enter into marketing distribution agreements regarding the PRODUCT with THIRD PARTIES in the MAJOR MARKET COUNTRIES only upon the prior written consent of Coulter, such consent not to be unreasonably withheld. SB may enter into marketing distribution agreements regarding the PRODUCT with THIRD PARTIES in those parts of the NON-USA TERRITORY which are not MAJOR MARKET COUNTRIES without the consent of Coulter, provided, however, SB shall provide written notice to Coulter at least fifteen (15) business days prior to entering into such distribution agreements. Such notice shall include the name of the THIRD PARTY distributor and a brief description of the proposed agreement. Notwithstanding anything in this Section 7.2.3(a), SB shall not be obligated to obtain Coulter's consent to enter into agreements solely related to supply chain distribution, including without limitation with radiopharmacies, in the NON-USA TERRITORY. (b) SB's obligations under this Agreement, as reasonably applicable, will apply to any THIRD PARTIES that enter into permitted marketing distribution or supply chain distribution agreements and sublicenses with SB with regard to the PRODUCT. Sales of PRODUCT by distributors or sublicensees of SB shall be handled as set forth in Section 8.4. 7.2.4 ROYALTIES IN NON-USA TERRITORY. (a) TERRITORY B. Subject to Sections 7.2.2(b), 7.2.5, 7.2.6 and 11.7, within forty five (45) days of the end of each calendar quarter following FIRST COMMERCIAL SALE in TERRITORY B, SB shall pay to Coulter royalties on NET SALES of Products by SB or its AFFILIATES and sublicensees in TERRITORY B at a rate of [*] of such NET SALES. Included with each payment shall be an accounting setting forth NET SALES in such territory during the applicable quarter, on a country-by-country basis expressed in unit sales, local currency and dollar equivalents. (b) TERRITORY C. Subject to Sections 7.2.5, 7.2.6 and 11.7, within forty five (45) days of the end of each calendar quarter following FIRST COMMERCIAL SALE in TERRITORY C, SB shall pay to Coulter royalties on NET SALES of PRODUCTS by SB or its AFFILIATES and sublicensees in TERRITORY C at a rate of [*] of such NET SALES. Included with each payment shall be an accounting setting forth NET SALES in such territory during the applicable quarter, on a country-by-country basis expressed in unit sales, local currency and dollar equivalents. (c) NON-USA DEDUCTION RATE. In the event that either (a) the Non-USA Deduction Rate (as defined below) exceeds [*] in any given continuous four (4) calendar quarter period (a "Rolling Year") or (b) the Non-USA Deduction Rate for any given Rolling Year is greater than [*] and at least [*] higher than the Non-USA Deduction Rate for the previous Rolling Year (for example, if in one Rolling Year the Non-USA Deduction Rate is [*] and in the next Rolling Year the Non-USA Deduction Rate is [*] or greater), SB shall, upon the written request of Coulter, provide Coulter with a reasonably detailed written explanation of why the Non-USA Deduction Rate was at such a level. Coulter shall make such a request to SB no later than sixty (60) days after the end of a given Rolling Year and SB shall provide Coulter with such an explanation within forty-five (45) days of Coulter's request. For purposes of this Section 7.2.4(c), "Non-USA Deduction Rate" shall equal, for any given calendar year, [*]. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 61. 75 7.2.5 INCREASE OR DECREASE IN ROYALTIES BASED ON NON-USA COGS. (a) In the event the NON-USA COGS plus Standard Royalties (as defined in Section 7.2.5(f)), as expressed as a percent of NET SALES, for any given country in the GUARANTEED COGS TERRITORY is greater than the GUARANTEED COGS PLUS ROYALTIES PERCENT (as set forth in Section 7.2.5(c)) for such country for the applicable calendar quarter, the royalties payable by SB to Coulter for such quarter pursuant to Section 7.2.4 shall be adjusted downward so that the NON-USA COGS plus royalty payable to Coulter for such country divided by NET SALES for such country for such quarter equals the GUARANTEED COGS PLUS ROYALTIES PERCENT, provided, however, in no event shall the Adjusted Royalties (as defined in Section 7.2.5(f)) paid to Coulter for such country for such quarter be less than the greater of (i) [*] of NET SALES for such country for such quarter and (ii) [*] per Bexxar Therapy (as defined in Section 7.2.5(f) below). This Section 7.2.5(a) shall have no further effect for a given country in the GUARANTEED COGS TERRITORY following the twentieth (20th) Quarter After First Commercial Sale in Such Country (as defined in Section 7.2.5(c)). (b) In the event the NON-USA COGS plus Standard Royalties, as expressed as a percent of NET SALES, for any given country in the GUARANTEED COGS TERRITORY is less than the GUARANTEED COGS PLUS ROYALTIES PERCENT for such country for the applicable calendar quarter, the royalties payable by SB to Coulter for such quarter pursuant to Section 7.2.4 shall be adjusted upward so that [*] of any difference between GUARANTEED COGS PLUS ROYALTIES PERCENT and NON-USA COGS plus Standard Royalties, as expressed as a percent of NET SALES, is added to the royalties which would otherwise be payable to Coulter under Section 7.2.4; provided, however, in no event shall the Adjusted Royalty paid to Coulter for such country for such quarter be greater than [*] of NET SALES for such country for such quarter. This Section 7.2.5(b) shall have no further effect for a given country in the GUARANTEED COGS TERRITORY following the twentieth (20th) Quarter After First Commercial Sale in Such Country (as defined in Section 7.2.5(c)). (c) "GUARANTEED COGS PLUS ROYALTIES PERCENT" shall be calculated on a country-by-country basis and a quarter-by-quarter basis and shall be equal to the following:
Quarter After First Guaranteed COGS Commercial Sale in Plus Royalties Such Country Percent [*] [*] [*] [*] [*] [*] [*] [*] [*] [*]
For the avoidance of doubt, in the event the FIRST COMMERCIAL SALE in a country in the GUARANTEED COGS TERRITORY occurs at any time after the first day of a quarter, NET SALES of PRODUCT made on the remaining days in such country in such quarter shall be subject to the [*] GUARANTEED COGS PLUS ROYALTIES PERCENT. For purposes of this Section 7.2.5(c), the [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 62. 76 subsequent quarter after such quarter during which the FIRST COMMERCIAL SALE is made in such country shall be deemed the first "Quarter After First Commercial Sale in Such Country." (d) In the event that, at any time following the [*] after FIRST COMMERCIAL SALE in a country in the GUARANTEED COGS TERRITORY, the NON-USA COGS plus Standard Royalties, as expressed as a percent of NET SALES, for such country is less than [*] of NET SALES for such country for such quarter, the royalties payable by SB to Coulter for such quarter pursuant to Section 7.2.4 shall be adjusted upward so that [*] of any difference between [*] of NET SALES for such country for such quarter and the NON-USA COGS plus Standard Royalties, as expressed as a percent of NET SALES, for such country is added to the royalties which would otherwise be payable to Coulter under Section 7.2.4, provided, however, in no event shall the Adjusted Royalty paid to Coulter for such country for such quarter be greater than [*] of NET SALES for such country for such quarter. (e) In the event SB assumes responsibility for manufacturing or having manufactured UNCONJUGATED ANTIBODY for any country in the GUARANTEED COGS TERRITORY under Section 9.6.1, for the purpose of calculating the NON-USA COGS for such country, [*]. (f) Included with the quarterly accounting SB provides to Coulter pursuant to Section 7.2.4 shall be, for each country in the GUARANTEED COGS TERRITORY: (i) [*], (ii) [*] and (iii) [*]. All of the foregoing calculations shall be performed [*] and on [*] for each country and expressed in dollars and as a percent of NET SALES for such country for such quarter. For purposes of this Section 7.2.5, "Bexxar Therapy" shall mean radioimmunotherapy using BEXXAR as administered (i), [*] (ii) [*] or (iii) [*]. (g) The Parties may discuss from time to time the need to expand the GUARANTEED COGS TERRITORY, and upon mutual agreement of the Parties, such GUARANTEED COGS TERRITORY may be expanded to include additional countries. 7.2.6 DECREASE IN ROYALTIES BASED ON SUBSTANTIAL COMPETITION. If, during the term of this Agreement, substantial competition occurs in a country of TERRITORY B or TERRITORY C between PRODUCT and one or more THIRD PARTY products which [*] as of the Effective Date, and for so long as such substantial competition is continuing, the royalty rates payable by SB to Coulter on NET SALES of PRODUCT under Sections 7.2.4(a) and 7.2.4(b) in the country or countries where such competition exists shall decrease by [*]. For purposes of this Paragraph, "substantial competition" shall mean a total sales volume of such THIRD PARTIES combined, in the particular country of the TERRITORY, of at least [*] of NET SALES volume of such PRODUCT in such country, and "continuing" shall mean a period of at least [*]. SB shall give Coulter written notice of such substantial competition with suitable and reasonable supporting documentation, including, for example, but not limited to, copies of market survey reports, THIRD PARTY bid activities, competitive promotional materials, and internal financial statements. Any reduction in the payment due from SB as a result of such THIRD PARTY competition shall be applied retroactively to the date on which substantial competition appeared in the TERRITORY as supported by reasonable documentation and shall be available to SB [*]. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 63. 77 7.3 NO DELEGATION. Subject to Section 7.2.3, each of the Parties may use only its own employees or the employees of one or more of its AFFILIATES in the course of exercising sales efforts with respect to its CO-PROMOTION rights under this Agreement in TERRITORY A, unless an alternative arrangement in TERRITORY A is approved in advance by the JCC or, unless Coulter loses its rights to CO-PROMOTE PRODUCT in TERRITORY A under Section 7.1.15, or unless an alternative arrangement is approved in advance by Coulter in the event of distribution or sublicense agreements in the MAJOR MARKET COUNTRIES under Sections 7.2.3 or 5.1.5. 7.4 PRODUCT COMPLAINTS. Each Party shall maintain a record of all complaints it receives with respect to the PRODUCT (each, a "Product Complaint"). For purposes of this Section 7.4, a "Product Complaint" is a report of an actual or potential failure of the PRODUCT to meet the standards set forth in regulatory filings or in agreements among the Parties. Such failure may involve the finished PRODUCT or one of its intermediate stages. The responsibilities of the Parties with respect to (a) notification of the Product Complaint from the receiving Party to the other Party and (b) the handling of Product Complaints shall all be performed in accordance with a procedure to be mutually agreed by the Parties after the Effective Date. 7.5 PRODUCT-RELATED INQUIRIES. For handling any medical or technical Product-related inquiries throughout the TERRITORY, the responsibilities of the Parties shall be performed in accordance with the allocation set forth on EXHIBIT I. 7.6 ADVERSE DRUG EVENT REPORTING. For the reporting of adverse drug experiences to regulatory authorities throughout the TERRITORY, the responsibilities of the Parties shall be performed in accordance with the pharmacovigilance agreement attached to this Agreement as EXHIBIT H. ARTICLE 8 ACCOUNTS AND RECORDS; WITHHOLDING TAX 8.1 NO DOUBLE COUNTING OF COSTS. For the purpose of determining any cost or expense which is shared by the Parties under this Agreement or otherwise invoiced by one Party to another under this Agreement, any cost or expense allocated by either Party to a particular cost category shall be consistent with the terms of this Agreement and shall not also be allocated to another category. In the event a cost or expense might arguably fall into more than one category, the FINANCE SUBTEAM shall determine which category such cost or expense most appropriately falls into. In the event the FINANCE SUBTEAM is unable to agree on such a determination, the JDC and/or JCC, as applicable, shall make such a determination. 8.2 RECORDS. Each Party shall keep accurate books and accounts of record in connection with any of the following costs which are incurred by it in accordance with this Agreement: DEVELOPMENT COSTS, MANUFACTURE DEVELOPMENT COSTS, SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS, SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS, COST OF GOODS, MARKETING COSTS, SALES COSTS, OTHER OPERATING INCOME/EXPENSE, DISTRIBUTION COSTS, NET SALES, OPERATING [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 64. 78 PROFIT OR LOSS, OUT-OF-POCKET COSTS, QA/QC COSTS, EXISTING THIRD PARTY LICENSE COSTS, NEW THIRD PARTY LICENSE COSTS, PATENT COSTS, and TRADEMARK COSTS, as well as any other costs which are relevant for determining any cost or expense which is shared by the Parties under this Agreement, charged by one Party to the other Party under this Agreement, or paid by one Party to the other Party under this Agreement. Such books and accounts of record shall be kept in sufficient detail to permit accurate determination of all figures necessary for verification of royalties, profits and other compensation required to be paid hereunder. Each Party shall maintain such records for a period of three (3) years after the end of the year in which they were generated. 8.3 AUDITS. Each Party, through an independent certified public accountant reasonably acceptable to the other Party, shall have the right, at its own expense, to access the books and records of the other Party for the sole purpose of verifying financial statements furnished by such Party under this Agreement. Such access shall be permitted during the term of the Agreement and for six (6) months after its termination; provided, however, that such examination shall not take place more often than once a year and shall not cover such records for more than the preceding two (2) years, unless a material discrepancy is found, in which case such examination shall include the records for the preceding three (3) years, provided further that such accountant shall report to the other Party only as to the accuracy of the statements and payments made by the Party under examination to the other Party, and further provided that such access shall be conducted after reasonable prior written notice to the other Party and during ordinary business hours and shall not be more frequent than once during each calendar year. The Parties agree to keep in strict confidence all information learned in the course of such audit, except when it is necessary to reveal such information in order to enforce its rights under this Agreement. In the event such audit reveals an underpayment of five percent (5%) or more of the amount actually due, the Party subject to the audit shall reimburse the auditing Party for the costs of such audit in addition to promptly remitting to the auditing Party the amount of any underpayment. In the event such audit reveals an overpayment of five percent (5%) or more of the amount actually due, the auditing Party shall promptly reimburse such amount to the Party subject to the audit. 8.4 SALES BY SUBLICENSEES. In the event SB grants licenses or sublicenses to others to make or sell the PRODUCT or grants THIRD PARTIES the right to distribute the PRODUCT, as permitted by Sections 5.1.5, 7.2.3 or 7.3, such licenses or sublicenses or distribution agreements shall include an obligation for the licensee, sublicensee or distributor to account for and report its NET SALES of such PRODUCTS on the same basis as if such sales were NET SALES by SB, and Coulter shall receive royalties in the same amounts as if the NET SALES of the licensee, sublicensee or distributor were NET SALES of SB. 8.5 WITHHOLDING. Coulter shall pay any and all taxes levied on account of royalties it receives under this Agreement. If laws or regulations require that taxes be withheld, SB will (i) deduct those taxes from the remittable royalty, (ii) pay the taxes to the proper taxing authority, and (iii) send evidence of the obligation together with proof of payment to Coulter within sixty (60) days following such payment. SB will cooperate to help Coulter minimize, in any lawful manner, the foregoing taxes and will provide Coulter with reasonable assistance to enable Coulter to recover such taxes as permitted by law. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 65. 79 8.6 CURRENCY OF PAYMENT. All dollar amounts contained in this Agreement are in United States Dollars (US$) and all payments to be made under this Agreement shall be made in United States Dollars to a bank account designated by the Party to be paid. Royalties earned shall first be determined in the currency of the country in which they are earned and then converted into United States Dollars using the rate of exchange used by SB for AFFILIATE conversions, provided however, that such rate of exchange shall approximate fair market value and, in the event of rapidly changing exchange rates, SB shall consult with Coulter and the Parties shall agree on a mechanism to assure that exchange rates are calculated to reflect fair market values on an ongoing basis. In each country where the local currency is blocked and cannot be removed from the country, royalties accrued in that country shall be paid to Coulter in the country in local currency by deposit in a local bank designated by Coulter, unless the Parties otherwise agree. 8.7 ACCOUNTING. No later than thirty (30) days after the end of each calendar quarter, each Party shall submit to the other Party an accounting of all costs incurred by such Party during such quarter which are to be shared with the other Party as provided under Sections 5.3.1, 5.3.3(b), 11.5.1, 11.5.3 or 19.15. In the event payment is due by the Party which is receiving the accounting to the incurring Party, the Party which owes the payment shall make such payment to the other Party within thirty (30) days after it has received such accounting. The Party receiving the payment shall issue an invoice to the Party making the payment which invoice shall be in the amount to be paid. ARTICLE 9 MANUFACTURING AND SUPPLY 9.1 COOPERATION. Coulter and SB will cooperate to determine manufacturing strategy and objectives for the supply of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY, consistent with the terms of this Article 9, the Lonza Agreements, the BI Pharma Agreements, the Cytogen Agreement and the Nordion Agreements (as such terms are defined below) and any NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS. Such strategy and objectives will be coordinated through the JDC, the JCC and the MANUFACTURE AND SUPPLY CHAIN SUBTEAM, as more fully described in Article 2. 9.2 PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS. It is acknowledged that, as of the Effective Date, Coulter has entered into the following agreement with Lonza Biologics PLC relating to the B1 MURINE ANTIBODY: Agreement between Lonza Biologics PLC and Coulter Pharmaceutical, Inc., dated May 28, 1998 (the "Lonza Agreement"). It is acknowledged that, as of the Effective Date Coulter will have entered into an agreement with BI Pharma relating to the manufacture of UNCONJUGATED ANTIBODY which is B1 MURINE ANTIBODY (the "BI Pharma Agreement"). [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 66. 80 It is acknowledged that, as of the Effective Date Coulter has entered into the following agreement with Cytogen Corporation relating to vialing of the B1 MURINE ANTIBODY: Manufacturing Agreement between Cytogen Corporation and Coulter Pharmaceutical, Inc., dated August 31, 1996, (the "Cytogen Agreement"). It is acknowledged that, as of the Effective Date Coulter has entered into the following agreements with MDS Nordion Inc. relating to the radiolabeling of the B1 MURINE ANTIBODY: Facilities Agreement between MDS Nordion Inc. and Coulter Pharmaceutical, Inc., dated August 31, 1998, and Supply Agreement between MDS Nordion Inc. and Coulter Pharmaceutical, Inc., dated August 31, 1998 (collectively, the "Nordion Agreements"). Copies of all of the foregoing agreements (collectively, the "PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS") have been provided to SB, except that the BI Pharma Agreement will be provided to SB prior to the Effective Date pursuant to Section 19.1. 9.3 CONFORMITY WITH PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS AND ANY NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS. As of the Effective Date, the terms of this Article 9, including, but not limited to, those relating to forecasts, ordering procedures, regulatory communication, regulatory inspections, QA/QC, inventory and testing procedures, are consistent with the PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS. Coulter shall not amend any of the PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS, and neither Coulter nor SB shall enter into any other THIRD PARTY manufacturing or supply chain agreements with Lonza, BI Pharma, Cytogen or Nordion or any other THIRD PARTY relating to the PRODUCT (collectively, "NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS") without the prior approval of the JDC, upon the review and recommendation of the MANUFACTURE AND SUPPLY CHAIN SUBTEAM. In order to facilitate such review and approval, Coulter shall provide such proposed amendments to the PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and such proposed NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS to the MANUFACTURE AND SUPPLY CHAIN SUBTEAM in a timely manner and the MANUFACTURE AND SUPPLY CHAIN SUBTEAM and JDC shall consider such proposals in a timely manner. In the event that Coulter, with the approval of the JDC, does enter into one or more NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS with Lonza, BI Pharma, Cytogen, Nordion or any other THIRD PARTY and the terms of such NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS are inconsistent with the terms of this Article 9, the Parties, upon the recommendation of the JDC, will amend the terms of this Article 9 to make it consistent with the terms of such NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 67. 81 9.4 RESPONSIBILITY FOR MANUFACTURE, SUPPLY AND DISTRIBUTION. 9.4.1 UNCONJUGATED ANTIBODY. Except as set forth in Sections 9.6 and 9.16, Coulter shall manufacture or have manufactured and supply all requirements in the TERRITORY for UNCONJUGATED ANTIBODY, whether for DEVELOPMENT or commercial sale in accordance with the Specifications (as defined in Section 9.4.4). Except as set forth in Sections 9.6 and 9.16, SB shall obtain all requirements in the TERRITORY for UNCONJUGATED ANTIBODY, whether for DEVELOPMENT or commercial sale, from Coulter. 9.4.2 RADIOLABELED ANTIBODY FOR DEVELOPMENT. [*] or [*] and [*], Coulter shall manufacture or have manufactured and supply all requirements of RADIOLABELED ANTIBODY for DEVELOPMENT in the TERRITORY in accordance with Specifications (as defined in Section 9.4.4). [*] and [*] and [*], SB shall obtain all requirements for RADIOLABELED ANTIBODY for DEVELOPMENT in the TERRITORY from Coulter, except in the event Coulter does not have sufficient capacity, in which case the Parties shall proceed in the manner described in Section 9.17. 9.4.3 RADIOLABELED ANTIBODY FOR COMMERCIAL SALE. (a) Coulter shall manufacture or have manufactured and supply all requirements of RADIOLABELED ANTIBODY for commercial sale in NORTH AMERICA except as otherwise provided by Section 9.17. SB shall obtain all requirements for RADIOLABELED ANTIBODY for commercial sale in NORTH AMERICA from Coulter except as otherwise provided by Section 9.17. (b) [*], Coulter shall manufacture or have manufactured and supply all requirements of RADIOLABELED ANTIBODY for commercial sale in TERRITORY B and TERRITORY C which the Parties agree Coulter is feasibly able to supply, given transportation and distribution constraints. [*], SB shall obtain all requirements for RADIOLABELED ANTIBODY for commercial sale in the TERRITORY from Coulter, except in the event Coulter does not have sufficient capacity, in which case the Parties shall proceed in the manner described in Section 9.17. In no event will Coulter be obligated to supply RADIOLABELED ANTIBODY hereunder [*]. In the event [*] under [*] for [*] to the [*]. 9.4.4 SPECIFICATIONS. As used in this Section 9.4, and throughout the Agreement, the term "Specifications" shall mean the requirements and standards pertaining to UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY (depending upon context) and consistent with filings made for REGULATORY APPROVAL and the PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS, which Specifications shall be reduced to writing by the JDC after the Effective Date. After the Effective Date such Specifications shall be subject to ongoing review by the Parties and may be modified from time to time, which modifications shall be approved by the JDC. The Specifications shall be release or stability specifications, as applicable, and each reference to Specifications shall mean the type of such specifications appropriate to context. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 68. 82 9.4.5 NON-COMPLIANCE WITH SPECIFICATIONS. (a) Coulter shall provide a Certificate of Analysis and a Certificate of Conformance (together, a "COA") from the THIRD PARTY manufacturer to SB as well as any report of separate quality control analysis of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY performed by Coulter with each shipment of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY specifying that such UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY conforms with the Specifications (as defined in Section 9.4.4). Coulter shall provide the results of such analysis along with any supporting data. SB shall be under no obligation to accept any shipment of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY without an accompanying COA. If the quality of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY supplied by Coulter under this Agreement is found not to conform to the Specifications as judged by comparison of the Specifications and the COA (as well as by comparison to information regarding the quality of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY developed by SB upon re-testing of such UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY, such re-testing to be performed by SB only in the event that SB is legally required to do so by the relevant regulatory authorities), SB shall notify Coulter of such nonconformity no later than thirty (30) days after receipt thereof in the case of UNCONJUGATED ANTIBODY and no later than three (3) days after receipt thereof in the case of RADIOLABELED ANTIBODY, and, subject to Section 9.4.5(b), Coulter shall replace, at no additional expense to SB, such UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY with new UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY which does conform to the Specifications within the minimum number of days after receipt of SB's notification under this Section 9.4.5 that such replacement is permitted under the relevant PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS; provided that the foregoing shall not be interpreted to change in any way Coulter's ongoing supply obligations with respect to other UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY ordered by SB in conformance with the supply procedures outlined in this Agreement. (b) If Coulter disagrees with SB's determination that the rejected shipment did not meet the Specifications, a sample of the rejected shipment shall be submitted to an independent, qualified THIRD PARTY laboratory that is mutually acceptable and selected by the parties promptly in good faith. Such laboratory shall determine whether the rejected UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY (as applicable) meets the Specifications, and such laboratory's determination shall be final and determinative for purposes of this Agreement, and Coulter's obligation to replace the non-conforming UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY outlined in Section 9.4.5(a) shall be stayed pending the result of such determination. The Party against whom the laboratory rules shall bear all costs of the laboratory testing. If the laboratory rules that the shipment failed to meet Specifications, the replacement shipment shall be at no charge to SB (provided SB paid for the initial shipment). If the laboratory rules the rejected shipment met the Specifications, then SB shall accept such batch for use and shall reimburse Coulter for the replacement shipment (including all costs of shipping and insurance). Coulter shall give SB written instructions as to how SB should, at Coulter's expense, dispose of the non-conforming material, and such instructions shall comply with all appropriate governmental requirements. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 69. 83 (c) In the event that a Party assumes responsibility for manufacturing UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY under Sections 9.6.1 or 9.6.2, the SB Supply Agreement or the Coulter Supply Agreement, as the case may be, shall contain provisions substantially similar to those set forth in this Section 9.4.5. 9.4.6 DISTRIBUTION. Distribution of the PRODUCT in TERRITORY A shall be handled in the manner described in Section 7.1.10. Distribution of the PRODUCT outside TERRITORY A shall be handled exclusively by SB. 9.5 ALLOCATION IN THE EVENT OF PRODUCT SHORTAGES. 9.5.1 ALLOCATION BETWEEN DEVELOPMENT AND COMMERCIALIZATION. In the event of shortages of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY, available supplies shall be allocated first to permit any ongoing clinical trials to continue on schedule unless the Parties otherwise agree at the time. Supplies remaining available after that initial allocation shall be allocated as between other DEVELOPMENT activities and commercialization activities by the JCC. The use of additional material allocated for DEVELOPMENT activities shall be determined by the JDC. 9.5.2 ALLOCATION OF SHORTAGES BETWEEN TERRITORIES (COMMERCIAL SUPPLY). In the event of shortages of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY, any material remaining available for commercial use after the allocations to DEVELOPMENT activities made under Section 9.5.1 shall be allocated by the JCC on a country-by-country basis, based upon [*] or some other mechanism to be mutually agreed upon by the Parties, provided, however, at least [*] of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY available for commercial sale [*]. 9.5.3 NO LIABILITY FOR PRODUCT SHORTAGES. The Parties recognize that there is no assurance that PRODUCT supply will be sufficient to meet demand. Neither Party shall be liable to the other for a failure to supply UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY, provided, however, that a Party may still be liable in the event of a failure to comply with the allocation mechanisms of Sections 9.5.1 or 9.5.2. 9.6 CHANGE IN RESPONSIBILITY FOR MANUFACTURE AND SUPPLY. 9.6.1 UNCONJUGATED ANTIBODY BY SB. If at any time during the term of the Agreement, SB desires to have responsibility for manufacture for supply of UNCONJUGATED ANTIBODY, in whole or in part, for sale in the TERRITORY, transferred from Coulter to SB, SB shall [*] to [*]. [*] in [*] for [*] (the "SB Supply Agreement"). The SB Supply Agreement shall include [*]. [*] a [*] the [*] to [*] of [*], the [*]. In any event, the decision whether to transfer the responsibility for supply of UNCONJUGATED ANTIBODY from Coulter to SB pursuant to an SB Supply Agreement [*]. If the Parties elect to enter into such SB Supply Agreement, to the extent a transfer under such SB Supply Agreement requires a modification of this Article 9, the Parties will promptly amend this Agreement to facilitate such modification. If the Parties elect to transfer responsibility for manufacture of bulk UNCONJUGATED ANTIBODY from Coulter to SB as set forth in this Section 9.6.1, the Parties shall confer regarding assistance, [*], to be provided to SB by Coulter to enable such transfer and the terms under which such assistance will be [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 70. 84 provided. In fulfilling any transferred manufacture obligations hereunder, SB [*] of [*]. Any transfer under this Section 9.6.1 pursuant to [*] SB Supply Agreement will be consistent with Coulter's obligations under the PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and any NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS. 9.6.2 UNCONJUGATED ANTIBODY OR RADIOLABELED ANTIBODY BY COULTER. As of the Effective Date, it is Coulter's intention that all manufacture and supply of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY for which it has responsibility under this Agreement will be performed by THIRD PARTIES pursuant to PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and/or NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS. If at any time during the term of the Agreement, Coulter believes it is in the best interest of the collaboration for Coulter to manufacture and supply UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY itself, in whole or in part, for sale in the TERRITORY, Coulter shall [*]. [*] is [*] in [*]. In any event, the decision whether to have Coulter supply UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY itself [*]. If the Parties decide Coulter should supply UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY itself, the Parties [*] one or more agreements to accomplish such purpose (a "Coulter Supply Agreement"). If the Parties elect to enter into such Coulter Supply Agreement, to the extent a transfer under such Coulter Supply Agreement requires a modification of this Article 9 or the rest of this Agreement, the Parties will promptly amend this Agreement to facilitate such modification. In fulfilling any transferred manufacture obligations hereunder, Coulter will [*] for [*]. Any transfer under this Section 9.6.2 pursuant to the negotiation of a Coulter Supply Agreement will be consistent with Coulter's obligations under the PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and any NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS. 9.6.3 If a Party incurs costs in making a proposal with regard to the transfer of manufacturing responsibility under Sections 9.6.1 or 9.6.2, it shall do so for its own account and without charge to the other Party under this Agreement. 9.7 COST OF GOODS FOR UNCONJUGATED ANTIBODY AND RADIOLABELED ANTIBODY FOR DEVELOPMENT AND MANUFACTURE DEVELOPMENT; MANUFACTURE DEVELOPMENT COSTS (INCLUDING CAPITAL EXPENDITURES). 9.7.1 COST OF GOODS FOR UNCONJUGATED ANTIBODY AND RADIOLABELED ANTIBODY FOR DEVELOPMENT AND MANUFACTURE DEVELOPMENT. Coulter shall provide UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY manufactured under Sections 9.4.1 and 9.4.2, respectively, for DEVELOPMENT and MANUFACTURE DEVELOPMENT in the TERRITORY at its COST OF GOODS. Such amounts for DEVELOPMENT and MANUFACTURE DEVELOPMENT in the TERRITORY shall be borne by the Parties in accordance with the [*] and 3.3.3. Coulter shall not invoice SB for the percentage of COST OF GOODS to be borne by SB for the use of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in Territory A Trials (as defined in Section 3.2.3) and Cross-Territory Trials (as defined in Section 3.2.3) [*] the [*] (as defined in [*]) [*]. Coulter shall be reimbursed by SB for the percentage of COST OF GOODS to be borne by SB for the use of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in (i) the Non-USA Territory Trials (defined in Section 3.2.3) [*] (ii) in all clinical trials [*] the [*] and (iii) for MANUFACTURE [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 71. 85 DEVELOPMENT pursuant to Section 3.3.3, each within thirty (30) days of SB's receipt of an invoice therefor from Coulter provided such invoice is submitted to SB after Coulter's receipt of such UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY from the THIRD PARTY manufacturer thereof and provided further that such reimbursement shall be paid to the extent that such UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY has met the appropriate quality assurance and quality control tests. [*], provided that SB's obligation to pay such invoice shall be subject to Section 9.4.5. 9.7.2 MANUFACTURE DEVELOPMENT COSTS (INCLUDING [*]). Any MANUFACTURE DEVELOPMENT COSTS, including [*], which are incurred by either Party with respect to the MANUFACTURE DEVELOPMENT for a process to be used to manufacture UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY shall be handled in accordance with the provisions of Section 3.3.3. 9.8 COST OF GOODS FOR UNCONJUGATED ANTIBODY AND RADIOLABELED ANTIBODY FOR COMMERCIAL SALE. 9.8.1 UNCONJUGATED ANTIBODY. As consideration for the manufacture and supply of UNCONJUGATED ANTIBODY under Section 9.4.1 for commercial sale in TERRITORY A, Coulter shall be reimbursed by SB for [*] of Coulter's COST OF GOODS of such UNCONJUGATED ANTIBODY within thirty (30) days of SB's receipt of an invoice therefor from Coulter. As consideration for the manufacture and supply of UNCONJUGATED ANTIBODY under Section 9.4.1 for commercial sale in TERRITORY B and TERRITORY C, subject to the last sentence of Section 7.2.2(b) Coulter shall be reimbursed by SB for Coulter's COST OF GOODS of such UNCONJUGATED ANTIBODY within thirty (30) days of SB's receipt of an invoice therefor from Coulter. Coulter may send an invoice to SB upon Coulter's receipt of an invoice from the THIRD PARTY supplier of the UNCONJUGATED ANTIBODY but only to the extent that Coulter has determined that such supply of UNCONJUGATED ANTIBODY has met all appropriate quality assurance and quality control tests. Each such Coulter invoice provided under this Section 9.81 shall be accompanied by [*], provided that SB's obligation to pay such invoice shall be subject to Section 9.4.5. In TERRITORY A, such reimbursed amounts shall be included as part of the COST OF GOODS element of SB's Operating Expenses for such quarter in accordance with Section 7.1.14 for the quarter in which such UNCONJUGATED ANTIBODY is sold, with Coulter's [*] ownership in the UNCONJUGATED ANTIBODY sold during said quarter in TERRITORY A to be included in the calculation of the COST OF GOODS element of Coulter's Operating Expenses for such quarter in accordance with Section 7.1.14 for the quarter in which such UNCONJUGATED ANTIBODY is sold. In TERRITORY B and TERRITORY C, such amounts shall be included in the NON-USA COGS for the quarter in which such UNCONJUGATED ANTIBODY is sold. 9.8.2 RADIOLABELED ANTIBODY. As consideration for (i) the manufacture and supply of RADIOLABELED ANTIBODY under Section 9.4.3(a) for commercial sale in NORTH AMERICA, and (ii) the manufacture and supply of RADIOLABELED ANTIBODY under Section 9.4.3(b) for commercial sale in TERRITORY B and TERRITORY C (under the conditions set forth in Section 9.4.3(b)), [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 72. 86 Coulter shall be reimbursed by SB for (i) [*] of Coulter's COST OF GOODS for converting UNCONJUGATED ANTIBODY into RADIOLABELED ANTIBODY related to such RADIOLABELED ANTIBODY for commercial sale in TERRITORY A and (ii) subject to the last sentence of Section 7.2.2(b), [*] of Coulter's COST OF GOODS for converting UNCONJUGATED ANTIBODY into RADIOLABELED ANTIBODY related to such RADIOLABELED ANTIBODY for commercial sale in TERRITORY B and TERRITORY C, within thirty (30) days of SB's receipt of an invoice therefor from Coulter. Coulter may send an invoice to SB upon Coulter's receipt of an invoice from the THIRD PARTY supplier of the RADIOLABELED ANTIBODY but only to the extent that Coulter has determined that such supply of RADIOLABELED ANTIBODY has met all appropriate quality assurance and quality control tests. Each such Coulter invoice provided under this Section 9.8.2 shall be accompanied [*], provided that SB's obligation to pay such invoice shall be subject to Section 9.4.5. In TERRITORY A, such reimbursed amounts shall be included as part of the COST OF GOODS element of SB's Operating Expenses for such quarter in accordance with Section 7.1.14 for the quarter in which such RADIOLABELED ANTIBODY is sold, with Coulter's [*] ownership in the RADIOLABELED ANTIBODY sold during said quarter in TERRITORY A to be included in the calculation of the COST OF GOODS element of Coulter's Operating Expenses for such quarter in accordance with Section 7.1.14 for the quarter in which such RADIOLABELED ANTIBODY is sold, less any corresponding COST OF GOODS already included under Section 9.8.1. In TERRITORY B and TERRITORY C, such amounts shall be included in the NON-USA COGS for the quarter in which such RADIOLABELED ANTIBODY is sold. 9.9 COST OF UNCONJUGATED ANTIBODY IN EVENT OF TRANSFER OF RESPONSIBILITY. (a) SB RESPONSIBILITY UNDER SECTION 9.6.1. In the event responsibility for manufacture and supply of UNCONJUGATED ANTIBODY is transferred from Coulter to SB pursuant to Section 9.6.1, SB will provide such UNCONJUGATED ANTIBODY for sale in TERRITORY A at the prices [*] attached to such SB Supply Agreement. Coulter will reimburse SB for the manufacture and supply of UNCONJUGATED ANTIBODY under Section 9.6.1 for commercial sale in TERRITORY A. In TERRITORY A, such reimbursed amounts shall be included as part of the COST OF GOODS element of Coulter's Operating Expenses for such quarter in accordance with Section 7.1.14 for the quarter in which such UNCONJUGATED ANTIBODY is sold, with [*] ownership in the UNCONJUGATED ANTIBODY sold during said quarter in TERRITORY A to be included in the calculation of the COST OF GOODS element of SB's Operating Expenses for such quarter in accordance with Section 7.1.14 for the quarter in which such UNCONJUGATED ANTIBODY is sold. In TERRITORY B and TERRITORY C, SB shall bear [*] of such cost and such amounts shall be included in the NON-USA COGS for the quarter in which such UNCONJUGATED ANTIBODY is sold, subject to Section 7.2.5(e). (b) COULTER RESPONSIBILITY UNDER SECTION 9.6.2. In the event responsibility for manufacture and supply of UNCONJUGATED ANTIBODY is transferred from a THIRD PARTY supplier to Coulter pursuant to Section 9.6.2, Coulter will provide such UNCONJUGATED ANTIBODY for sale in TERRITORY A at the prices set forth on the [*] attached to such Coulter Supply Agreement. SB will reimburse Coulter for the manufacture and supply of UNCONJUGATED ANTIBODY under Section 9.6.2 for commercial sale in TERRITORY A according to the same procedures outlined in Section 9.8.1 for SB reimbursement to Coulter. In TERRITORY A, such reimbursed amounts shall be included as part of the COST OF GOODS element of SB's Operating [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 73. 87 Expenses for such quarter in accordance with Section 7.1.14 for the quarter in which such UNCONJUGATED ANTIBODY is sold, with Coulter's [*] ownership in the UNCONJUGATED ANTIBODY sold during said quarter in TERRITORY A to be included in the calculation of the COST OF GOODS element of Coulter's Operating Expenses for such quarter in accordance with Section 7.1.14 for the quarter in which such UNCONJUGATED ANTIBODY is sold. In TERRITORY B and TERRITORY C, SB shall bear [*] of such cost and such amounts shall be included in the NON-USA COGS for the quarter in which such UNCONJUGATED ANTIBODY is sold. 9.10 EUROPEAN FACILITY. 9.10.1 OVERVIEW. Subject to the time periods and mechanisms described in this Section 9.10, either SB shall establish a [*] to supply the requirements of EUROPE for [*] (the "EUROPEAN FACILITY") or Coulter shall have the right described in Section 9.10.4 to adjust or terminate SB's license in EUROPE. If SB does proceed to establish a EUROPEAN FACILITY, [*]. The EUROPEAN FACILITY, if established by SB, shall be designed and constructed to supply [*] for commercial sale in EUROPE, in accordance with all applicable laws and regulations, [*]. [*]. 9.10.2 SELECTION OF SB OPTION. (a) Within [*] of the Effective Date, SB (with the reasonable assistance of Coulter, such assistance including, without limitation, the provision of necessary information by Coulter to SB as reasonably requested by SB) shall have identified the options for a EUROPEAN FACILITY and shall have communicated such options, along with an analysis of the advantages and disadvantages of each option, to the MANUFACTURE AND SUPPLY CHAIN SUBTEAM which shall have responsibility for monitoring SB's progress in identifying options for the EUROPEAN FACILITY and fulfilling SB's obligations under this Section 9.10. Included with such analysis shall be a determination of the applicable European Facility Commencement Date (as defined in Section 9.10.3(ii)), relative to FIRST COMMERCIAL SALE in [*] for each EUROPEAN FACILITY option being considered by SB. (b) In the event that at some point following SB's evaluation of the options for a EUROPEAN FACILITY identified under Section 9.10.2(a), SB determines that its first choice is to supply TERRITORY B (excluding [*]) out of the [*] (as defined in [*]), then SB shall provide notice of such election to Coulter, specifying in such notice SB's second choice as a supply site. Within sixty (60) days of receiving such notice from SB, Coulter shall advise SB whether it approves such use of the [*]; provided, however, in no event shall Coulter be obligated to advise SB of its decision regarding such approval earlier than [*] to the European Facility Commencement Date (as defined in Section 9.10.3(ii)) for SB's second choice as a supply site as specified in the SB notice to Coulter. Coulter's consent, not to be unreasonably withheld, shall be required in order to designate the [*] as the EUROPEAN FACILITY. If Coulter does not consent to such designation, then SB shall proceed with its second choice as a supply site, or if SB does not have a second choice, it shall so notify Coulter. In the event Coulter does not approve the use of the [*] and SB has notified Coulter that it has no second choice, then SB shall be deemed to have given the notice under Section 9.10.2(c). [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 74. 88 (c) At any time, SB may notify Coulter in writing that it has determined not to construct a EUROPEAN FACILITY. In such event, Coulter's rights under Section 9.10.4 shall immediately become effective. (d) At the request of SB, Coulter shall provide reasonable assistance, within Coulter's area of expertise, to help SB identify and validate an appropriate site for the EUROPEAN FACILITY in order to allow SB to meet its obligations under Section 9.10 to supply [*] for sale in TERRITORY B (excluding [*]) and TERRITORY C (excluding [*]). Provision of such assistance shall include, but not be limited to, (i) [*], and (ii) [*]. In the event that SB requests that Coulter perform work under this Section 9.10.2(d), SB shall reimburse Coulter for all OUT-OF-POCKET COSTS incurred by Coulter with respect to such performance within thirty (30) days of receipt of an invoice from Coulter, provided that travel costs incurred by Coulter under this Section 9.10.2(d) shall be based on business class airfares for travel outside the United States, coach airfares for travel inside the United States and reasonable business accommodations. All work or other assistance provided to SB under this Section 9.10.2(d), such as, without limitation, [*], meetings reasonably incidental to other business between the Parties, and the provision of existing Coulter reports, data and information to assist SB with SB's activities under this Section (such as the provision of information to assist SB with responses to questions or requests from regulatory authorities) shall be provided to SB without reimbursement for FTE resources, except in the case where (i) [*] or (ii) Coulter is requested to undertake an individual project that requires more than [*] of effort, provided that Coulter provides SB advance notice (which may be verbal) that the project is of [*]. In the event that such trip is made under clause (i) or a project is undertaken under clause (ii) by such Coulter FTE, SB shall reimburse Coulter on an FTE rate basis for the hours spent rendering such assistance, at an FTE rate of [*]. 9.10.3 DEFINITIONS. For purposes of this Section 9.10, the following definitions shall apply: (i) "European Facility Completion Date" shall mean that date which is the earlier of (1) [*] after the later of the date of FIRST COMMERCIAL SALE in [*] and the date of FIRST COMMERCIAL SALE in [*]; or (2) [*] after the earlier of the date of FIRST COMMERCIAL SALE in [*] or the date of FIRST COMMERCIAL SALE in [*]. (ii) "European Facility Commencement Date" shall mean that date by which the MANUFACTURE AND SUPPLY CHAIN SUBTEAM determines it would be reasonably necessary for SB to have entered into an agreement with a THIRD PARTY pursuant to which such THIRD PARTY will commence construction of the EUROPEAN FACILITY in such time as to finish construction and have such EUROPEAN FACILITY available to manufacture and supply SB's estimated requirements of [*] for commercial sale in [*], in accordance with all applicable European laws and regulations, by the European Facility Completion Date, provided, however, in no event will the European Facility Commencement Date be later than eighteen (18) months prior to the European Facility Completion Date. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 75. 89 9.10.4 SB PERFORMANCE; COULTER REMEDIES. Following the determination of its facility choice, as provided above, SB shall, not later than the European Facility Commencement Date (as defined in Section 9.10.3(ii)), execute a binding agreement with a THIRD PARTY for the construction of the EUROPEAN FACILITY ("European Facility Agreement"). SB shall thereafter use COMMERCIALLY REASONABLE EFFORTS to complete the construction of such facility and have it ready for commercial supply not later than the European Facility Completion Date (as defined in Section 9.10.3(i)). In the event that (i) SB notifies Coulter that it does not intend to enter into a European Facility Agreement, (ii) SB has not entered into a European Facility Agreement by the European Facility Commencement Date or (iii) at any time after [*] after the European Facility Commencement Date, the MANUFACTURE AND SUPPLY CHAIN SUBTEAM makes a good faith determination that, for reasons other than a FORCE MAJEURE OCCURRENCE, the EUROPEAN FACILITY is not reasonably likely to be completed and available to manufacture and supply SB's estimated requirements of [*] for commercial sale in EUROPE by [*] after the European Facility Completion Date (as defined in Section 9.10.3(i)), Coulter may, at any time during the [*] month period after such occurrence described in clause (i), (ii) or (iii), give notice to SB that Coulter intends to (A) adjust the licenses granted by Coulter under this Agreement to exclude EUROPE from the TERRITORY or (B) adjust the licenses granted by Coulter under Article 5 of this Agreement to become non-exclusive for EUROPE. In the event Coulter elects option (A), it shall provide written notice to SB and, on the [*] anniversary of the date of such notice, the terms of Section 13.4 shall apply for EUROPE. In the event Coulter elects option (B), it shall provide written notice to SB and, as of the date of such notice, the terms of Section 13.5 shall apply for EUROPE. 9.10.5 MILESTONE PAYMENT. (a) In the event that the [*] (as defined in [*]) is selected by SB as the EUROPEAN FACILITY and new construction of less than [*] is required to establish the [*] as the EUROPEAN FACILITY, SB will notify Coulter of such selection and within thirty (30) days of such selection date (which shall, in any event, be no later than thirty (30) days following the European Facility Commencement Date) (as defined in Section 9.10.3(ii)), SB shall pay to Coulter [*]. (b) In the event that (A) a facility other than the [*] is selected by SB as the EUROPEAN FACILITY or (B) the [*] is selected by SB as the EUROPEAN FACILITY but new construction in excess of [*] is required to establish the [*] as the EUROPEAN FACILITY, SB will notify Coulter of such selection and will have the following payment obligations to Coulter: (i) within thirty (30) days after initiation of construction of the EUROPEAN FACILITY, SB shall pay to Coulter [*]; and (ii) within thirty (30) days of filing of an MAA supplement to manufacture PRODUCT at such EUROPEAN FACILITY for commercial supply, SB shall pay to Coulter an additional [*]; and (iii) within thirty (30) days of receipt of approval of an MAA supplement to manufacture PRODUCT at such EUROPEAN FACILITY for commercial supply and other necessary REGULATORY APPROVALs, if any, SB shall pay to Coulter an additional [*]. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 76. 90 (c) All amounts paid under this Section 9.10.5 shall be non-refundable and non-creditable, provided, however, in the event of termination of this Agreement by SB due to material breach by Coulter, the foregoing shall not preclude SB from seeking whatever damages are available at law. 9.10.6 REMAINDER OF THE NON-USA TERRITORY. In the event that, pursuant to Section 9.10.4 Coulter adjusts the licenses granted under this Agreement to exclude EUROPE from the TERRITORY or adjusts the licenses granted under this Agreement to become non-exclusive for EUROPE, SB shall notify Coulter whether it intends to develop and commercialize PRODUCT for sale in the remainder of TERRITORY B (i.e., all countries other than those of EUROPE) and TERRITORY C. If SB elects not to develop and commercialize Product for sale in the remainder of TERRITORY B and TERRITORY C, the licenses granted by Coulter under this Agreement shall be automatically adjusted to exclude the remainder of TERRITORY B and TERRITORY C and the terms of Section 13.4 shall apply to such countries. If SB elects to develop and commercialize PRODUCT for sale in the remainder of TERRITORY B and TERRITORY C, Coulter shall be under no obligation to supply PRODUCT to SB for such DEVELOPMENT and commercialization (except for Canada and Mexico) and SB shall continue to have the obligations with respect to such countries as are set forth in Sections 7.2.1 and 7.2.2. In the event SB elects to develop and commercialize PRODUCT for sale in the remainder of TERRITORY B and TERRITORY C and Coulter offers to supply PRODUCT for such countries, but SB is not using good faith efforts to obtain REGULATORY APPROVAL in such country and sell PRODUCT in such country, the licenses granted by Coulter under this Agreement shall be automatically adjusted to exclude such countries and the terms of Section 13.4 shall apply to such countries. 9.11 TERM OF MANUFACTURE AND SUPPLY. The term of the manufacture and supply of PRODUCT under this Article 9 will be the term of this Agreement. 9.12 FORECASTS. 9.12.1 UNCONJUGATED ANTIBODY AND RADIOLABELED ANTIBODY. (a) SUPPLY FOR DEVELOPMENT PURPOSES. During the first five (5) business days of (i) each month in the case of RADIOLABELED ANTIBODY and (ii) every third month in the case of UNCONJUGATED ANTIBODY, the MANUFACTURE AND SUPPLY CHAIN SUBTEAM will confer regarding each Party's requirements for UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY for use in DEVELOPMENT in the TERRITORY for an appropriate amount of time following the date of such conference, depending upon the lead time for ordering such UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY for DEVELOPMENT and MANUFACTURE DEVELOPMENT supplies from THIRD PARTY suppliers. This approach to production planning for DEVELOPMENT and MANUFACTURE DEVELOPMENT purposes may be modified as mutually agreed to by the Parties based upon the Parties' experience in conducting clinical trials and other DEVELOPMENT and MANUFACTURE DEVELOPMENT activities. (b) COMMERCIAL SUPPLY. Upon receipt of REGULATORY APPROVAL for a PRODUCT in any country in the TERRITORY, the Parties agree that UNCONJUGATED ANTIBODY for commercial use will be ordered pursuant to a forecasting mechanism developed by the [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 77. 91 MANUFACTURE AND SUPPLY CHAIN SUBTEAM. Such forecasting mechanism shall (i) meet the needs of the Parties for commercial supply of UNCONJUGATED ANTIBODY and (ii) be consistent with the terms and conditions of the applicable PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENT and any NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENT. In the event that one of the Parties assumes responsibility for the manufacture and supply of the UNCONJUGATED ANTIBODY pursuant to Section 9.6, 9.16 or 9.17, the Parties shall meet to determine an appropriate forecasting mechanism in the event of such transfer of responsibility. If the Parties determine that greater flexibility in forecasting supply of UNCONJUGATED ANTIBODY is required than is permitted under the applicable PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENT and any NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENT, Coulter shall use COMMERCIALLY REASONABLE EFFORTS to negotiate appropriate modifications to such agreements. Further, the MANUFACTURE AND SUPPLY CHAIN SUBTEAM will meet to develop a detailed procedure pursuant to which Coulter will be provided with the information necessary to submit consolidated purchase orders to the THIRD PARTY manufacturer of UNCONJUGATED ANTIBODY and to establish a schedule setting forth those dates after which UNCONJUGATED ANTIBODY purchase orders may not be placed by the Parties. Such procedure and schedule shall be in accordance with the terms and provisions of the PRE-EXISTING THIRD Party MANUFACTURE AND SUPPLY CHAIN AGREEMENT and any NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENT under which UNCONJUGATED ANTIBODY will be manufactured. Once such a procedure is established, the Parties will work together to collect such information and provide it to Coulter in sufficient time for Coulter to submit such consolidated purchase orders to the THIRD PARTY manufacturer of UNCONJUGATED ANTIBODY. 9.12.2 PRODUCTION ORDERING MECHANISM FOR RADIOLABELED ANTIBODY FOR DEVELOPMENT AND COMMERCIAL SALE. The Parties acknowledge the careful planning and detailed information required in order to provide accurate and timely orders for RADIOLABELED ANTIBODY to the THIRD PARTY manufacturer of such RADIOLABELED ANTIBODY given the precise time frames required for radiolabeling of UNCONJUGATED ANTIBODY. Within ninety (90) days of the Effective Date, the MANUFACTURE AND SUPPLY CHAIN SUBTEAM will meet to develop a detailed procedure pursuant to which Coulter will be provided with the information necessary to submit consolidated purchase orders to the THIRD PARTY manufacturer of RADIOLABELED ANTIBODY and to establish a schedule setting forth those dates after which RADIOLABELED ANTIBODY purchase orders may not be placed by the Parties. Such procedure and schedule shall be in accordance with the terms and provisions of the PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENT and any NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENT under which RADIOLABELED ANTIBODY will be manufactured. Once such a procedure is established, the Parties will work together to collect such information and provide it to Coulter in sufficient time for Coulter to submit such consolidated purchase orders to the THIRD PARTY manufacturer of RADIOLABELED ANTIBODY. 9.12.3 DELIVERY; SHIPMENT. The UNCONJUGATED ANTIBODY and RADIOLABELED Antibody supplied under this Agreement will be delivered [*] the THIRD PARTY manufacturer's facility ([*]). [*] shall be construed in accordance with [*]. The MANUFACTURE AND SUPPLY CHAIN SUBTEAM will determine which Party will make shipping arrangements with the carriers. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 78. 92 9.13 QUALITY CONTROL; TESTING. Coulter shall maintain a quality control and testing program consistent with GMP, as required by the FDA and/or any other governmental entity whether in the United States or part of another applicable foreign jurisdiction, with respect to the manufacture of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY by or on behalf of Coulter hereunder. SB shall be entitled to collaborate with Coulter to audit the quality control program for the manufacture of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY. 9.14 MANUFACTURING REGULATORY COMPLIANCE. 9.14.1 TERRITORY A. Any manufacture of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY for DEVELOPMENT and MANUFACTURE DEVELOPMENT purposes or commercial sale in TERRITORY A, shall be performed in full compliance with GCP, GLP and GMP and all applicable United States laws and regulations. Coulter or its designee shall serve as the point of contact with the FDA and any other applicable governmental entity in TERRITORY A concerning the manufacture and supply of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY, but may, as appropriate, request the assistance of SB or the JDC with FDA and/or other applicable governmental entity communications. 9.14.2 TERRITORY B and TERRITORY C. Any manufacture of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY for DEVELOPMENT and MANUFACTURE DEVELOPMENT purposes or commercial sale in TERRITORY B or TERRITORY C shall be performed in full compliance with GCP, GLP and GMP and all applicable United States laws and regulations. SB will notify Coulter of any regulatory requirements for manufacture of UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY for sale in TERRITORY B or TERRITORY C with which it wishes THIRD PARTY manufacturers of UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY to comply. To the extent Coulter can cause such manufacturers to comply with such regulatory requirements under the PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and any NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS, Coulter will do so. If Coulter is unable to do so pursuant to such agreements, the MANUFACTURE AND SUPPLY CHAIN SUBTEAM will meet to discuss how best to address such regulatory requirements, including seeking to amend the applicable PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and/or NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS to cause such THIRD PARTY manufacturer to be in compliance with the applicable regulatory requirements. The Parties will seek to enter into three-way technical agreements with such manufacturers for the purpose of defining the respective responsibilities of the Parties and such manufacturers for quality control and regulatory compliance. SB shall be entitled to collaborate with Coulter to audit GCP, GLP, and GMP and any other agreed-to compliance for the manufacture of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY. To the extent permitted by applicable laws, SB or its designee shall serve as the point of contact with the foreign equivalents of the FDA and any other applicable governmental entity in TERRITORY B and TERRITORY C concerning the manufacture and supply of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY, but may, as appropriate, request the assistance of Coulter or the JDC with communications with such governmental entities. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 79. 93 9.15 RECALLS. The Parties shall immediately inform each other in writing of all information related to (a) any incident relating to a PRODUCT and/or any lot of a PRODUCT that is the subject of recall, market withdrawal or correction, or (b) any PRODUCT that may require, whether based on manufacturing defect, tampering, or otherwise, a recall, field alert, product withdrawal or field correction arising from any defect in any such PRODUCT provided under this Agreement. If either Party believes that a recall of UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY is desirable or required by law, it will promptly notify the other Party. The Parties will then discuss reasonably and in good faith whether such recall is appropriate or required and the manner in which any recall shall be handled; provided, however, in the event either Party determines that a recall is necessary, such recall shall be implemented. Coulter shall be solely responsible for the handling and disposition of such recalls of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in TERRITORY A, pursuant to procedures set forth on EXHIBIT J. SB shall cooperate with Coulter in allowing such recall in TERRITORY A to occur pursuant to the procedures set forth on EXHIBIT J. SB shall be solely responsible for the handling and disposition of such recalls of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in the NON-USA TERRITORY, pursuant to procedures set forth on EXHIBIT J. Coulter shall cooperate with SB in allowing such recall in the NON-USA TERRITORY to occur pursuant to the procedures set forth on EXHIBIT J. EXHIBIT J may be modified at any time by the MANUFACTURE AND SUPPLY CHAIN SUBTEAM subject to the approval of the JDC and JCC. 9.16 CORRECTIVE ACTION FOR SUPPLY OF UNCONJUGATED ANTIBODY. In order to ensure an uninterrupted supply of UNCONJUGATED ANTIBODY, the Parties agree that in the event the JDC makes a good faith determination that (i) a THIRD PARTY manufacturer which manufactures UNCONJUGATED ANTIBODY and any back-up manufacturer to such THIRD PARTY manufacturer, or (ii) SB (in the event SB is manufacturing UNCONJUGATED ANTIBODY under Section 9.6.1), or (iii) Coulter (in the event Coulter is manufacturing UNCONJUGATED ANTIBODY under Section 9.6.2) (collectively, the "Antibody Manufacturer") has been or will be an unreliable supplier (as defined by the MANUFACTURE AND SUPPLY CHAIN SUBTEAM) of UNCONJUGATED ANTIBODY for Development or commercial sale (a "Failure to Supply Unconjugated Antibody") in TERRITORY A, TERRITORY B or TERRITORY C (the "Affected Territory"), the Parties shall meet promptly to work with the then-current Antibody Manufacturer to attempt to rectify the situation. If such Antibody Manufacturer is unable to assure the Parties, to their reasonable satisfaction, that it will thereafter be a reliable supplier of UNCONJUGATED ANTIBODY, as determined by the JDC, within such Affected Territory, then, subject to the terms of any applicable PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and/or NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS, the JDC shall either (i) identify another THIRD PARTY manufacturer to become a new Antibody Manufacturer for UNCONJUGATED ANTIBODY in such Affected Territory or (ii) agree that SB or Coulter may supply such UNCONJUGATED ANTIBODY in such Affected Territory (assuming that SB or Coulter is not the Antibody Manufacturer who is unable to supply). In the event the JDC elects to use another THIRD PARTY manufacturer to become a new Antibody Manufacturer for UNCONJUGATED ANTIBODY in such Affected Territory, Coulter shall promptly enter into a manufacture agreement with such THIRD PARTY for the Affected Territory. If SB becomes the Antibody Manufacturer pursuant to this Section 9.16, the Parties shall agree on the economic terms of such supply and Coulter shall transfer all Coulter KNOW-HOW, to the extent permitted under applicable THIRD PARTY agreements, reasonably required to [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 80. 94 permit SB to manufacture UNCONJUGATED ANTIBODY for DEVELOPMENT purposes or commercial sale in such Affected Territory. In the event a Failure to Supply Unconjugated Antibody by a THIRD PARTY Antibody Manufacturer occurs for reasons beyond the reasonable control of Coulter and SB itself becomes the Antibody Manufacturer pursuant to this Section 9.16 for commercial sale in TERRITORY B or TERRITORY C, the royalty payable by SB to Coulter for sales in TERRITORY B or TERRITORY C, as the case may be, shall thereafter be reduced by [*] of NET SALES of such PRODUCT, subject to a floor of [*] royalty on such sales in TERRITORY B and TERRITORY C. In the event a Failure to Supply Unconjugated Antibody by a Third Party Antibody Manufacturer occurs for reasons within the reasonable control of Coulter and SB itself becomes the Antibody Manufacturer pursuant to this Section 9.16 for commercial sale in TERRITORY B or TERRITORY C, the royalty payable by SB to Coulter for sales in TERRITORY B or TERRITORY C, as the case may be, shall thereafter be reduced by [*] of NET SALES of such PRODUCT, subject to a floor of [*] royalty on such sales in TERRITORY B and TERRITORY C. For purposes of this Section 9.16, TERRITORY A shall include Canada and Mexico and TERRITORY B and TERRITORY C shall exclude such countries. 9.17 CORRECTIVE ACTION FOR SUPPLY OF RADIOLABELED ANTIBODY. In order to ensure an uninterrupted supply of RADIOLABELED ANTIBODY, the Parties agree that in the event the JDC makes a good faith determination that the THIRD PARTY manufacturer and any back-up manufacturer to such THIRD PARTY manufacturer, which conjugates UNCONJUGATED ANTIBODY to (131)Iodine to create RADIOLABELED ANTIBODY for DEVELOPMENT or commercial sale in NORTH AMERICA, TERRITORY B (during the time Coulter is obligated to supply in TERRITORY B under this Agreement) or TERRITORY C (during the time Coulter is obligated to supply in TERRITORY C under this Agreement) (collectively, the "Radiolabeling Manufacturer") has been or will be an unreliable supplier (as defined by the MANUFACTURE AND SUPPLY CHAIN SUBTEAM) of RADIOLABELED ANTIBODY, the Parties shall meet promptly to work with the then-current Radiolabeling Manufacturer to attempt to rectify the situation. If such Radiolabeling Manufacturer is unable to assure the Parties, to their reasonable satisfaction, that it will thereafter be a reliable supplier of RADIOLABELED ANTIBODY as determined by the JDC, then, subject to the terms of any applicable PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and/or NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS, the JDC shall either (i) identify another THIRD PARTY manufacturer to become a new Radiolabeling Manufacturer for RADIOLABELED ANTIBODY in NORTH AMERICA, TERRITORY B or TERRITORY C, as applicable, or (ii) agree that SB may supply such RADIOLABELED ANTIBODY in NORTH AMERICA, TERRITORY B or TERRITORY C, as applicable, upon terms to be agreed to by the Parties. In the event the JDC elects to use another THIRD PARTY manufacturer to become a new Radiolabeling Manufacturer for RADIOLABELED ANTIBODY in NORTH AMERICA, TERRITORY B or TERRITORY C under this Section 9.17, Coulter shall promptly enter into a manufacture agreement with such THIRD PARTY. If SB manufactures RADIOLABELED ANTIBODY for NORTH AMERICA, TERRITORY B or TERRITORY C pursuant to this Section 9.17, Coulter shall transfer all Coulter KNOW-HOW reasonably required to permit SB to manufacture RADIOLABELED ANTIBODY for DEVELOPMENT purposes or commercial sale in NORTH AMERICA, TERRITORY B or TERRITORY C. For purposes of this Section 9.17, TERRITORY B shall exclude Canada. For purposes of this Section 9.17, TERRITORY C shall exclude Mexico. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 81. 95 9.18 EXCHANGE OF INFORMATION. In the event of a transfer of manufacturing responsibility from Coulter to SB pursuant to Section 9.6.1, 9.16 or 9.17, the Parties will undertake to exchange and to use COMMERCIALLY REASONABLE EFFORTS to cause THIRD PARTY manufacturers to exchange, on a regular basis, all data relating to the manufacture of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY, provided that such exchange shall in all cases be consistent with the obligations under any PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS. All information transferred, provided or exchanged under this Section 9.18 will be subject to the confidentiality requirements set forth in Article 17. ARTICLE 10 TRADEMARKS 10.1 SELECTION AND OWNERSHIP OF TRADEMARKS. 10.1.1 TERRITORY A. The Parties agree to use the TRADEMARK Bexxar(TM) for purposes of CO-PROMOTING the PRODUCT in TERRITORY A, unless the JCC selects a different TRADEMARK for use in TERRITORY A. SB acknowledges Coulter's ownership of Bexxar(TM) and that Coulter shall be the owner of any other TRADEMARK(S) selected and used for purposes of CO-PROMOTING the PRODUCT in TERRITORY A (collectively, "Territory A Trademark(s)") and agrees that it will do nothing inconsistent with such ownership. SB further agrees that nothing in this Agreement shall give SB any right, title or interest in the Territory A Trademark(s) other than the right to use the Territory A Trademark(s) in accordance with, and during the term of, this Agreement. 10.1.2 NON-USA TERRITORY. The JCC will select the TRADEMARK(S) for marketing the PRODUCT in the NON-USA TERRITORY. In the event that the TRADEMARK(S) selected for use in the NON-USA TERRITORY is one which was identified by SB to Coulter prior to the Effective Date as having already undergone searching by SB, such TRADEMARK(S) shall be owned by SB ("SB Trademarks"). At the termination of this Agreement, SB shall continue to have unrestricted ownership of SB Trademarks throughout the NON-USA TERRITORY. In the event that the TRADEMARK(S) selected for use in the NON-USA TERRITORY is not such an SB Trademark, such TRADEMARK(S) shall be owned by Coulter ("Coulter Trademarks"). At the termination of this Agreement, Coulter shall continue to have unrestricted ownership of such Coulter Trademarks throughout the TERRITORY, subject to SB's right to own such TRADEMARK in TERRITORY B and TERRITORY C after the expiration of the Agreement as provided in Section 13.1.2. SB acknowledges Coulter's ownership of the Coulter Trademarks, agrees that it will do nothing inconsistent with such ownership, and agrees that nothing in this Agreement shall give SB any right, title or interest in the Coulter Trademarks other than the right to use the Coulter Trademarks in accordance with this Agreement. Coulter acknowledges SB's ownership of the SB Trademarks, agrees that it will do nothing inconsistent with such ownership, and agrees that nothing in this Agreement shall give Coulter any right, title or interest in the SB Trademarks other than the right to use the SB Trademarks in accordance with this Agreement. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 82. 96 10.2 DEVELOPMENT OF TRADEMARKS. 10.2.1 TERRITORY A. Coulter shall create, search, prosecute, register and maintain any and all Territory A Trademarks. All OUT-OF-POCKET COSTS paid by Coulter after the Effective Date for creating, searching, registering and maintaining such Territory A Trademarks shall be included in TRADEMARK COSTS. 10.2.2 NON-USA TERRITORY. SB shall, at its sole expense, create, search, prosecute, register, and maintain all SB Trademarks developed for the purposes of this Agreement that will be used in the NON-USA TERRITORY. SB will further defend such SB Trademarks against any infringement and other claims made by THIRD PARTIES in the NON-USA TERRITORY. Coulter shall, at its sole expense, create, search, prosecute, register, and maintain all Coulter Trademarks developed for the purposes of this Agreement that will be used in the NON-USA TERRITORY. Coulter will further defend such Coulter Trademarks against any infringement and other claims made by THIRD PARTIES in the NON-USA TERRITORY. 10.2.3 DEVELOPMENT OF ADDITIONAL TRADEMARKS IN THE NON-USA TERRITORY. Coulter and SB agree that Coulter may, at its sole discretion and expense, create, search, prosecute, register and maintain concurrently TRADEMARKS not confusingly similar to the SB Trademarks, but bearing the same description of goods, to be used in the NON-USA TERRITORY at the termination of this Agreement or in the event Coulter otherwise obtains marketing rights for PRODUCTS in portions of the NON-USA TERRITORY. 10.3 LICENSE GRANTS. 10.3.1 TERRITORY A. Coulter hereby agrees to grant to SB an exclusive (except as to Coulter), royalty-free license to use the Territory A Trademark(s) (defined in Section 10.1.1) for the making, use, sale, offer for sale and importation of the PRODUCT in TERRITORY A for the term of the Agreement, subject to Coulter's right to CO-PROMOTE PRODUCT in TERRITORY A in accordance with the terms of this Agreement. Such license shall be granted promptly after each Territory A Trademark is selected in accordance with Section 10.1.1. 10.3.2 NON-USA TERRITORY. Coulter hereby agrees to grant to SB an exclusive, royalty-free license to use the Coulter Trademark(s) (as defined in Section 10.1.2) for the making, use, sale, offer for sale and importation of the PRODUCT in the NON-USA TERRITORY for the term of the Agreement, subject to the use by Coulter of the Coulter Trademark for any purpose related to Coulter's supply obligations under this Agreement related to the PRODUCT in the NON-USA TERRITORY for the term of the Agreement. Such license shall be granted promptly after each Coulter Trademark is selected in accordance with Section 10.1.2. SB hereby agrees to grant to Coulter a non-exclusive, royalty-free license to use the SB Trademark(s) (as defined in Section 10.1.2) for any use related to Coulter's supply obligations under this Agreement related to the PRODUCT in the NON-USA TERRITORY for the term of the Agreement. Such license shall be granted promptly after each SB Trademark is selected in accordance with Section 10.1.2. 10.3.3 LICENSED TRADEMARKS. The TRADEMARKS to be licensed by the Parties pursuant to Sections 10.3.1 and 10.3.2 shall be, collectively, the "Licensed Trademarks." [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 83. 97 10.4 USE OF TRADEMARKS. 10.4.1 TERRITORY A TRADEMARKS AND COULTER TRADEMARKS. With regard to Territory A Trademark(s) (as defined in Section 10.1.1) or in the event that the TRADEMARK for the PRODUCT in the NON-USA TERRITORY is a Coulter Trademark (as defined in Section 10.1.2), SB agrees to conform with Coulter's customary guidelines under this Article 10 with respect to manner of use, and to maintain Coulter's quality standards with respect to the goods sold and services provided in connection with the TRADEMARKS. Further, except when used in accordance with any usage guidelines provided by Coulter, SB shall submit to Coulter any materials bearing the TRADEMARKS for review and approval prior to the use thereof and shall make no use of the TRADEMARKS without Coulter's written consent. SB shall execute any documents required in the reasonable opinion of Coulter to be entered as a "registered user" or recorded licensee of the TRADEMARKS, or to be removed as registered user or licensee thereof. 10.4.2 SB TRADEMARKS. In the event that the TRADEMARK for the PRODUCT in the NON-USA TERRITORY is a SB Trademark (as defined in Section 10.1.2), Coulter agrees to conform with SB's customary guidelines under this Article 10 with respect to manner of use, and to maintain SB's quality standards with respect to the goods sold and services provided in connection with the TRADEMARKS. Further, except when used in accordance with any usage guidelines provided by SB, Coulter shall submit to SB any materials bearing the TRADEMARKS for review and approval prior to the use thereof and shall make no use of the TRADEMARKS without SB's written consent. Coulter shall execute any documents required in the reasonable opinion of SB to be entered as a "registered user" or recorded licensee of the TRADEMARKS, or to be removed as registered user or licensee thereof. 10.4.3 QUALITY MAINTENANCE. SB agrees to cooperate with Coulter in facilitating Coulter's quality assurance responsibilities by permitting reasonable inspection of SB's operations as they pertain to the Territory A Trademarks (as defined in Section 10.1.1) and the Coulter Trademarks (as defined in Section 10.1.2) and supplying Coulter with specimens of use of such TRADEMARKS upon reasonable request, but in any case no more often than twice each calendar year. SB will comply with all applicable laws and regulations and obtain all government approvals pertaining to the sale, distribution and advertising of PRODUCTS offered in the NON-USA TERRITORY under the Coulter Trademarks and covered by this Agreement. Coulter agrees to cooperate with SB in facilitating SB's quality assurance responsibilities by permitting reasonable inspection of Coulter's operations as they pertain to the SB Trademarks (as defined in Section 10.1.2) and supplying SB with specimens of use of the SB Trademarks upon reasonable request, but in any case no more often than twice each calendar year. 10.5 INFRINGEMENT OF TRADEMARKS. 10.5.1 TERRITORY A. Each Party shall notify the JCC promptly upon learning of any actual, alleged or threatened infringement of any Territory A Trademark or of any unfair trade practices, trade dress imitation, passing off of counterfeit goods, or like offenses, or any such claims brought by a THIRD PARTY against a PRODUCT in TERRITORY A (hereinafter "Infringement"). Upon learning of such Infringement, the JCC shall confer with the Parties [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 84. 98 regarding strategy and filing of an action to deal with the Infringement. In the event the JCC determines that an action with regard to such Infringement is necessary or desirable, Coulter shall have the first right, but not the obligation, to institute, prosecute and control any legal proceedings in its own name and by its own counsel to prevent or restrain such Infringement, and SB agrees to give Coulter its reasonable cooperation and assistance. In the event Coulter elects not to exercise such first right, SB shall have the right, but not the obligation, to institute, prosecute and control any legal proceedings in its own name and by its own counsel to prevent or restrain such Infringement, and Coulter agrees to give SB its reasonable cooperation and assistance. 10.5.2 TERRITORY B; TERRITORY C. Each Party shall notify the other Party promptly upon learning of any actual, alleged or threatened infringement of any TRADEMARK or of any unfair trade practices, trade dress imitation, passing off of counterfeit goods, or like offenses, or any such claims brought by a THIRD PARTY against a PRODUCT in TERRITORY B or TERRITORY C (hereinafter "Infringement"). If the TRADEMARK involved is an SB Trademark (as defined in Section 10.1.2), or if the Infringement is otherwise not related to a Coulter Trademark (as defined in Section 10.1.2), SB shall be primarily responsible for instituting, prosecuting and controlling any legal proceedings in its own name and by its own counsel to prevent or restrain such Infringement, and Coulter agrees to give SB its reasonable cooperation and assistance. If the TRADEMARK involved is a Coulter Trademark, Coulter shall be primarily responsible for instituting, prosecuting and controlling any legal proceedings in its own name and by its own counsel to prevent or restrain such Infringement, and SB agrees to give Coulter its reasonable cooperation and assistance. 10.5.3 STAND-BY RIGHTS. If the Party having the primary right to institute, prosecute, and control such Infringement action under Sections 10.5.1 or 10.5.2 fails to do so within a period of ninety (90) days after receiving notice of the Infringement, or if that Party, after initiating an action, determines to discontinue such action, the other Party shall have the right to bring and control or take over any such action by counsel of its own choice, unless prevented from doing so by the laws of the country where the Infringement occurred or is threatened. 10.6 COSTS RELATED TO INFRINGEMENT. 10.6.1 TERRITORY A. All TRADEMARK COSTS related to TERRITORY A and all OUT-OF-POCKET COSTS paid to outside counsel and other THIRD PARTIES which were incurred in bringing, maintaining and prosecuting any action described in Section 10.5.1 shall be included as part of the determination of the JOINT P&L as outlined in Section 7.1.14 and any recovery shall be added to NET SALES in TERRITORY A, provided that such OUT-OF-POCKET COSTS were incurred after the Effective Date and approved by the JCC. 10.6.2 TERRITORY B; TERRITORY C. All OUT-OF-POCKET COSTS paid to outside counsel and other THIRD PARTIES which were incurred in bringing, maintaining and prosecuting any action described in Section 10.5.2 shall be borne by the Party incurring the expense and any recovery shall be kept by the Party which was responsible for bringing the action. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 85. 99 10.7 TRADE DRESS. 10.7.1 TERRITORY A. In TERRITORY A, PRODUCT will be packaged in standard Coulter packaging, subject to Section 7.1.8. If SB's rights to PRODUCT are terminated in accordance with this Agreement in TERRITORY A, SB shall not be permitted to use Coulter packaging with respect to PRODUCT in such territory. 10.7.2 TERRITORY B AND TERRITORY C. In TERRITORY B and TERRITORY C, PRODUCT will be packaged in standard SB packaging, subject to Section 7.1.8. If SB's rights to PRODUCT are terminated in accordance with this Agreement in a particular country, Coulter shall not be permitted to use SB packaging with respect to PRODUCT in such country, and shall not permit its subsequent licensees to use SB packaging with respect to PRODUCT in such country. ARTICLE 11 PROSECUTION, MAINTENANCE AND INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS 11.1 INVENTIONS. 11.1.1 Coulter shall own all INVENTIONS made solely by its employees and agents, and all patent applications and patents claiming such INVENTIONS. SB shall own all INVENTIONS made solely by its employees and agents, and all patent applications and patents claiming such INVENTIONS. All INVENTIONS made jointly by employees or agents of Coulter and employees or agents of SB and all patent applications and patents claiming such INVENTIONS shall be owned jointly by Coulter and SB. All determinations of inventorship under this Section 11.1.1 shall be in accordance with U.S. law. The Parties will seek to negotiate provisions in agreements with THIRD PARTY manufacturers or suppliers of services relating to the PRODUCT which provide the Parties with ownership or CONTROL of any intellectual property relating to the PRODUCT which arises out of such THIRD PARTY agreements, sufficient for Coulter or SB to be able to manufacture and sell PRODUCT throughout the TERRITORY upon expiration of this Agreement and/or to transfer such intellectual property to a THIRD PARTY supplier. All such provisions shall be approved in advance by the JDC. 11.1.2 Each Party shall promptly disclose to the other Party the complete texts of all patent applications filed by the disclosing party after the Effective Date which relate to ANTI-CD-20 ANTIBODY as well as all information received after the Effective Date concerning the institution or possible institution of any interference, opposition, re-examination, reissue, revocation, nullification or any official proceeding involving PATENT RIGHTS anywhere in the TERRITORY. The Party reviewing such disclosure shall have the right to review all such pending applications and other proceedings and make recommendations concerning them and their conduct. The Parties shall keep each other promptly and fully informed of the course of patent prosecution or other proceedings relating to ANTI-CD-20 ANTIBODY including by providing copies of substantive communications, search reports and THIRD PARTY observations submitted to or received from patent offices throughout the TERRITORY. The Parties shall provide such patent consultation at no cost except as otherwise provided in this Agreement. In addition, SB and [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 86. 100 Coulter shall each disclose to the other and discuss any INVENTION relating to ANTI-CD20 ANTIBODY and the desirability of filing a United States patent application covering the INVENTION, as well as any foreign counterparts, except that SB shall have no obligation to disclose to Coulter [*] other than jointly with an employee or agent of Coulter related to [*]. To facilitate such discussions and any decision-making with respect to jointly-owned INVENTIONS, each Party will appoint a "patent coordinator," who will have the authority to participate in such discussions and make such decisions on behalf of such Party. With respect to INVENTIONS relating to ANTI-CD20 ANTIBODY owned by one Party, the Party owning the INVENTION shall make the final decision with respect to any such filings, provided that SB shall have the right, but not the obligation, to assume responsibility for any COULTER PATENT RIGHT which does not cover a jointly-owned INVENTION, or any part of such a COULTER PATENT RIGHT, which Coulter intends to abandon or otherwise cause or allow to be forfeited (unless Coulter has decided to abandon or forfeit such COULTER PATENT RIGHT in order to preserve other COULTER PATENT Rights or because the substance of such claims are covered under other COULTER PATENT RIGHTS and SB's patent coordinator has confirmed that such decision will not diminish the patent protection for PRODUCT). Coulter shall give SB reasonable written notice prior to abandonment or other forfeiture of any COULTER PATENT RIGHT relating to ANTI-CD20 ANTIBODY or any part of a COULTER PATENT RIGHT relating to ANTI-CD20 ANTIBODY so as to permit SB to exercise its rights under this Section. With respect to jointly-owned INVENTIONS, the patent coordinators shall jointly make the final decision with respect to any such filings, as well as the prosecution and maintenance of the PATENT RIGHTS which result from such filings. Each Party shall have the right to select patent counsel and to take such other actions as are reasonably appropriate to prepare, file, prosecute and maintain patent protection with respect to its INVENTIONS, consistent with the terms of this Article 11. 11.2 PROSECUTION AND MAINTENANCE OF PATENT RIGHTS; ALLOCATION OF PATENT COSTS. Each Party shall be responsible throughout the TERRITORY for prosecuting and maintaining its own PATENT RIGHTS, subject to Section 11.1.2, and Coulter shall be responsible throughout the TERRITORY for prosecuting and maintaining any jointly-owned INVENTIONS, subject to Section 11.1.2, and all such activity shall be at the responsible Party's expense except as otherwise provided in this Article 11. All PATENT COSTS in the TERRITORY arising after the Effective Date for the COULTER PATENT RIGHTS or the SB PATENT RIGHTS which cover jointly-owned INVENTIONS shall be shared equally by the Parties. All PATENT COSTS in TERRITORY A arising after the Effective Date for the COULTER PATENT RIGHTS or the SB PATENT RIGHTS shall be borne equally by the Parties to the extent that they relate to ANTI-CD20 ANTIBODY, otherwise they are borne by the Party incurring such expense. All PATENT COSTS outside of TERRITORY A arising after the Effective Date for the COULTER PATENT RIGHTS which do not cover jointly-owned INVENTIONS shall be borne solely by Coulter. All PATENT COSTS outside of TERRITORY A arising after the Effective Date for the SB PATENT RIGHTS which do not cover jointly-owned INVENTIONS shall be borne solely by SB. 11.3 COOPERATION. Each of the Parties shall execute or have executed by its appropriate employees, representatives, agents, and contractors such documents as may be necessary to obtain, perfect or maintain any PATENT RIGHTS filed or to be filed pursuant to this Agreement, and shall cooperate with the other Party so far as reasonably necessary with respect [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 87. 101 to furnishing all information and data in its possession reasonably necessary to obtain or maintain such PATENT RIGHTS. 11.4 INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS. 11.4.1 RIGHT TO BRING ACTION; TREATMENT OF RECOVERY. (a) If either Party should become aware of any infringement or threatened infringement or misappropriation, as the case may be, in any country of the TERRITORY of any INTELLECTUAL PROPERTY RIGHTS of the other Party, it shall promptly notify such other Party in writing. As soon as practicable, the Parties shall confer on the particulars of such infringement or misappropriation and the possible courses of action to be taken. Subject to Sections 11.4.3 and 11.4.4, the Party holding the affected INTELLECTUAL PROPERTY RIGHTS (or, in the case of jointly-owned INVENTIONS, Coulter) shall have the first right, but not the obligation, to institute, prosecute and control any legal proceedings in its own name and by its own counsel to prevent or restrain such infringement, and the other Party shall have the right to be represented in such action by its own counsel. If one Party brings any such action or proceeding, whether under this Section 11.4.1(a) or under Section 11.4.2, the other Party hereby consents to being joined as a Party plaintiff where necessary and, in case of joining, such other Party agrees to give the Party bringing such suit reasonable assistance and authority to file and to prosecute such suit, at the exercise of the Party bringing such suit. All OUT-OF-POCKET COSTS of any such action or proceeding in TERRITORY A shall be included as part of the determination of the JOINT P&L as outlined in Section 7.1.14 to the extent that such costs relate to ANTI-CD20 ANTIBODY. All OUT-OF-POCKET COSTS of any such action or proceeding in TERRITORY B or TERRITORY C shall be borne by the Party incurring such costs. (b) In the event a Party recovers any damages or other monetary awards in any proceedings or by way of settlement under Section 11.4.3(b) for infringement or misappropriation of INTELLECTUAL PROPERTY RIGHTS in TERRITORY A, or royalties as a result of a license grant to a THIRD PARTY in TERRITORY A under Section 11.4.3(b), (collectively "Recovery") such Recovery shall be treated as NET SALES for purposes of the JOINT P&L. In the event a Party recovers any damages or other monetary awards in any proceedings or by way of settlement under Section 11.4.3(a) for infringement or misappropriation of INTELLECTUAL PROPERTY RIGHTS in TERRITORY B or TERRITORY C, such recovery shall be reimbursed first to each Party on a pro-rata basis for any OUT-OF-POCKET COSTS incurred by such Party pursuant to the last sentence of Section 11.4.1(a) or Section 11.4.2 and then the excess shall be distributed between the Parties on a pro-rata basis in proportion to the estimated economic loss incurred by each of them as a result of the reduction in NET SALES of PRODUCT in TERRITORY B and TERRITORY C caused by the infringements, provided that the Party bringing the action shall be entitled to at least one half of such excess, and further provided that, in the event that SB is the Party bringing the action, in no event shall the amount of Coulter's share exceed the royalties Coulter would have received had the sales which were the subject of the action been NET SALES. 11.4.2 If the Party having the primary right to institute, prosecute, and control such infringement or misappropriation action under Section 11.4.1(a) fails to do so within a [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 88. 102 period of ninety (90) days after receiving notice of the infringement or misappropriation, or if that Party, after initiating an action, determines to discontinue such action, the other Party shall have the right, but not the obligation, to the extent related to ANTI-CD20 ANTIBODY, to bring and control or take over any such action by counsel of its own choice, unless prevented from doing so by the laws of the country where the infringement or misappropriation occurred or is threatened, and subject to Sections 11.4.3 and 11.4.4. All OUT-OF-POCKET COSTS of any such action or proceeding in TERRITORY A shall be included as part of the JOINT P&L to the extent that such costs relate to ANTI-CD20 ANTIBODY. All OUT-OF-POCKET COSTS of any such action or proceeding in TERRITORY B or TERRITORY C shall be borne by the Party incurring such costs. 11.4.3 (a) OUTSIDE TERRITORY A. The Party conducting such infringement or misappropriation action outside of TERRITORY A shall have full control over its conduct, including settlement thereof provided that the Parties shall keep one another informed of the status of and of their respective activities regarding any litigation or settlement thereof concerning PRODUCT in the TERRITORY and provided further that no settlement or consent judgment or other voluntary final disposition of any suit defended or action brought by a Party pursuant to Section 11.4.1(a) or Section 11.4.2 may be entered into without the consent of the other Party if such settlement would require the other Party to be subject to an injunction or to make a monetary payment or would otherwise adversely affect the other Party's rights under this Agreement. (b) INSIDE TERRITORY A. In the event that the Parties decide that it is desirable to grant a license related to any ANTI-CD-20 ANTIBODY to a THIRD PARTY under Coulter's INTELLECTUAL PROPERTY RIGHTS in TERRITORY A, or in the event that the Party controlling the action in TERRITORY A under Section 11.4.1(a) or Section 11.4.2 desires to settle such action by granting a license to a THIRD PARTY under Coulter's INTELLECTUAL PROPERTY RIGHTS in TERRITORY A or in the event that the granting of a license to a THIRD PARTY under Coulter's INTELLECTUAL PROPERTY RIGHTS in TERRITORY A is part of a condition required by a THIRD PARTY as part of the THIRD PARTY'S forbearance to sue Coulter and/or SB and/or any regulatory agency or otherwise forbear to exercise or agree to waive a legal or administrative or governmental action or right or impediment against Coulter and/or SB with respect to preventing Coulter and/or SB from lawfully commercializing PRODUCT in TERRITORY A, the Parties will promptly meet to determine the appropriate and lawful course of action and no settlement or consent judgment or other voluntary final disposition of any suit defended or action brought by a Party pursuant to Section 11.4.1(a) or Section 11.4.2 in TERRITORY A which includes the grant of such a license may be entered into without the consent of the other Party. 11.4.4 In connection with any action taken by either Party against a THIRD PARTY to protect or enforce any INTELLECTUAL PROPERTY RIGHTS, the other Party shall, if requested, consult with the Party taking such action, and make available as witnesses its employees or as evidence any materials, and/or data as are reasonably necessary for the furtherance of such action. The OUT-OF-POCKET COSTS in connection with the providing of witnesses and/or the making available of any materials and/or data shall be borne by the Party incurring them. If such OUT-OF POCKET COSTS are incurred in TERRITORY A, they shall be included as part of the JOINT [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 89. 103 P&L, and if they are incurred in TERRITORY B or TERRITORY C, they shall be borne by the Party incurring such costs 11.5 DEFENSE AND SETTLEMENT OF THIRD PARTY CLAIMS FOR PRODUCTS IN THE TERRITORY; OPPOSITION AND REVOCATION PROCEEDINGS. 11.5.1 DEFENSE AND SETTLEMENT OF THIRD PARTY CLAIMS IN TERRITORY A. If a THIRD PARTY asserts that a patent or other right owned by it is infringed by the manufacture, use or sale of any PRODUCT in TERRITORY A, the Party first obtaining knowledge of such a claim shall immediately provide the other Party notice of such claim and the related facts in reasonable detail. The JDC or JCC (as appropriate) shall determine how best to control the defense of any such claim (including the bringing of a declaratory judgment action) with respect to PRODUCT. In the event the JDC or JCC cannot agree on the defense of any such claim or whether or not a particular Party shall control the defense, the Parties shall submit such issue(s) promptly thereafter to an UNAFFILIATED EXPERT who is a patent attorney. The OUT-OF-POCKET COSTS of engaging such UNAFFILIATED EXPERT patent attorney for such determination shall be shared equally by the Parties. The determination of such UNAFFILIATED EXPERT patent attorney shall be binding on the JDC or JCC. The entity that controls the defense of a given claim with respect to PRODUCT shall also have the right to control settlement of such claim; provided, however, that (a) if one Party controls, no settlement or consent judgment or other voluntary final disposition of any such claim may be entered into without the consent of the other Party if such settlement would require the other Party to be subject to an injunction or to make a monetary payment or would otherwise adversely affect the other Party's rights under this Agreement, and (b) such Party shall solely bear all OUT-OF-POCKET COSTS it incurs with respect to such defense which costs did not receive the prior written approval of the JDC or JCC (as appropriate). 11.5.2 DEFENSE AND SETTLEMENT OF THIRD PARTY CLAIMS OUTSIDE OF TERRITORY A. If a THIRD PARTY asserts that a patent or other right owned by it is infringed by the manufacture, use or sale of any PRODUCT outside of TERRITORY A, the Party first obtaining knowledge of such a claim shall immediately provide the other Party notice of such claim and the related facts in reasonable detail. SB shall have the right, but not the obligation, to defend such suit at its own expense. Coulter and SB shall provide reasonable assistance to one another and reasonably cooperate in any such litigation at the other's request without expense to the requesting party. 11.5.3 RE-EXAMINATION, OPPOSITION AND REVOCATION PROCEEDINGS. After the Effective Date, in the event either Coulter or SB believes that initiating a re-examination, revocation or opposition proceeding against patent rights held by a THIRD PARTY is necessary or desirable in order to manufacture or develop or commercialize the PRODUCT anywhere in the TERRITORY, or otherwise assure that their activities under this Agreement do not infringe the intellectual property rights of such THIRD PARTY, then the JDC will discuss the situation in good faith. In the event that the JDC cannot make a unanimous decision regarding whether or not such revocation or opposition proceeding is necessary or desirable or whether or not a particular Party shall conduct such proceeding, the Parties shall submit such issue(s) promptly thereafter to an UNAFFILIATED EXPERT who is a patent attorney. The OUT-OF-POCKET COSTS of engaging such UNAFFILIATED EXPERT patent attorney for such determination shall be shared equally by the [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 90. 104 Parties. The determination of such UNAFFILIATED EXPERT shall be binding on the JDC. SB shall have the first right, but not the obligation, to bring such re-examination, opposition or revocation action outside of TERRITORY A. Coulter and SB shall provide reasonable assistance to one another and reasonably cooperate in any such litigation at the other's request without expense to the requesting party. All PATENT COSTS inside TERRITORY A related to any such re-examination, opposition and revocation proceeding brought by a Party in accordance with this Section 11.5.3 shall be included as part of the JOINT P&L. All PATENT COSTS outside of TERRITORY A related to any such re-examination, opposition and revocation proceeding brought by a Party in accordance with this Section 11.5.3 shall be borne by the Party that incurred such expense. 11.6 ALLOCATION OF EXPENSES. The OUT-OF-POCKET COSTS incurred by either Party under Section 11.2 shall be allocated between the Parties as provided in Section 11.2. The OUT-OF-POCKET COSTS incurred by either Party under Section 11.4 shall be allocated between the Parties as provided in Section 11.4. The OUT-OF-POCKET COSTS incurred by either Party of engaging an UNAFFILIATED EXPERT, patent defense, settlement and judgments pursuant to Section 11.5 with respect to PRODUCT in TERRITORY A shall be a shared expense of the Parties. The OUT-OF-POCKET COSTS of patent defense, settlement and judgments pursuant to Sections 11.5.1 and 11.5.2 with respect to PRODUCT outside of TERRITORY A shall be borne by the Party which incurred such expense. The OUT-OF-POCKET COSTS incurred by either Party of engaging an UNAFFILIATED EXPERT pursuant to Section 11.5.3 shall be a shared expense of the Parties. All PATENT COSTS incurred by a Party pursuant to Section 11.5.3 shall be allocated between the Parties as provided in Section 11.5.3. 11.7 ROYALTY REDUCTION IN TERRITORY B or TERRITORY C. If, as a result of settlement procedures or litigation under Section 11.5, SB is required to pay a THIRD PARTY a royalty in TERRITORY B or TERRITORY C or make any payment of any kind for the right to use the Coulter INTELLECTUAL PROPERTY RIGHTS in a particular country in TERRITORY B or TERRITORY C, SB may deduct, from the amount of royalties owed to Coulter in connection with the country, [*] of the amount of the royalty or such other amount payable to the THIRD PARTY in respect of the sale of the allegedly infringing PRODUCT, provided that (i) the balance of such royalty or other payment obligation shall be included in NON-USA COGS, and (ii) in any event, the net royalty payable to Coulter for that country shall not be reduced to an amount less than [*] of NET SALES in such country or [*] per Bexxar Therapy (as defined in Section 7.2.5(f)), whichever is greater. 11.8 FORECLOSURE UNDER SECURITY AGREEMENT. In order to grant SB a security interest in certain collateral, the Parties have executed a Security Agreement (the "Security Agreement") concurrent with the execution of the LOAN AGREEMENT. Such collateral includes those COULTER PATENT RIGHTS identified in the Security Agreement The Parties agree that the following procedures shall apply in the event of default by Coulter under the Security Agreement and the exercise of rights and remedies by SB thereunder. As used in this Section 11.8, the term "Secured Patents" shall refer to all COULTER PATENT RIGHTS included within the defined term "Collateral" under the Security Agreement. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 91. 105 11.8.1 FORECLOSURE NOT A TERMINATION OF THIS AGREEMENT. A default by Coulter under the Security Agreement and the exercise of any rights or remedies by SB thereunder shall not constitute a termination of this Agreement. Such termination shall occur, if at all, only upon the events specified in Article 13 or as otherwise provided in this Agreement. So long as this Agreement remains in effect, the provisions of this Article 11 shall apply to the Secured Patents, whether title is in the name of Coulter or SB. Notwithstanding the above, in the event SB exercises its rights or remedies under the Security Agreement, and this Agreement remains in effect, SB shall be entitled to one hundred percent (100%) of all royalties or other remuneration generated as a result of any license granted by the Parties to a THIRD PARTY in TERRITORY A under Section 11.4.3(b). 11.8.2 TRANSFER OF SECURED PATENTS. (a) If SB exercises rights or remedies under the Security Agreement, then, so long as title to the Secured Patents remains in the name of Coulter, Coulter shall continue to perform prosecution, maintenance, and enforcement of such PATENT RIGHTS, subject, however, to the terms of this Article 11, provided that in performing such work, Coulter shall at all times keep SB fully informed of its actions with respect to the Secured Patents and shall follow SB's instructions with respect to such matters to the extent that they may affects rights within the field of ANTI-CD20 ANTIBODIES. (b) If SB forecloses on the Secured Patents or otherwise obtains title thereto, Coulter shall promptly and fully cooperate in the orderly transfer of title from Coulter to SB of such Secured Patents and shall execute all documents necessary to effect such transfer at its expense. Coulter shall make available to SB , at Coulter's expense, copies of all its relevant files regarding the creation, prosecution, maintenance, enforcement and extension of the Secured Patents. (c) Any transfer of the Secured Patents to any party other than SB shall be subject to an agreement by the transferee to take such patents subject to the terms of this Section 11.8, as if such transferee were SB. 11.8.3 MAINTENANCE OF SECURED PATENTS. (a) If SB obtains title to the Secured Patents, it shall, at its expense, prosecute and maintain the Secured Patents, provided that: (i) SB shall keep Coulter promptly and fully informed of the course of patent prosecution and other proceedings including by providing Coulter with copies of substantive communications, search reports and third party observations submitted to or received from patent offices throughout the TERRITORY or Japan, (ii) SB will disclose to Coulter all information concerning the institution or possible institution of any interference, opposition, re-examination, reissue, revocation, nullification or any official proceeding involving a Secured Patent anywhere in the TERRITORY or Japan, and [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 92. 106 (iii) subject to Section 11.8.3(c), SB shall use COMMERCIALLY REASONABLE EFFORTS with respect to such prosecution and maintenance. Notwithstanding the above, Coulter shall reimburse SB for all costs it incurs with respect to the prosecution or maintenance of Secured Patents to the extent that such costs are not related to the field of ANTI-CD20 ANTIBODIES within thirty (30) days following receipt from SB of an accounting for such costs, together with a related invoice. (b) Coulter shall have the right to review all such pending applications and other proceedings outlined in Sections 11.8.3(a) and (b) and make recommendations to SB concerning them and their conduct, provided that SB shall have sole discretion with respect to all decisions related thereto, except as otherwise provided in Section 11.8.3(d). Coulter shall provide such patent consultation to SB at no cost to SB. Coulter shall hold all information disclosed to it under this section as confidential subject to the provisions of Article 17. (c) Notwithstanding Section 11.8.3(a)(iii), SB shall have no obligation to maintain or prosecute any claims contained in the Secured Patents, and may abandon or otherwise cause or allow such claims to be forfeited. (d) If SB determines (i) to abandon any Secured Patents, or any part of a Secured Patent, (ii) to cause or allow such patent or part thereof to be forfeited, or (iii) to cease maintaining or prosecuting claims of the Secured Patents, it shall provide Coulter at least sixty (60) days prior notice of such proposed action or event and Coulter shall have the right, but not the obligation, to assume responsibility for (a) such Secured Patent or part thereof which SB intends to abandon or otherwise cause or allow to be forfeited, or (b) prosecuting or maintaining claims of such Secured Patents, provided that Coulter shall bear one hundred percent (100%) of all reasonable expenses incurred by SB with respect to the prosecution and maintenance of such Secured Patent or part thereof to be forfeited, whether or not outside the field of ANTI-CD20 ANTIBODIES from the date Coulter receives such notice until the date that either (x) Coulter assumes such responsibility, or (y) Coulter notifies SB, in writing, that Coulter is not interested in assuming such responsibility. (e) SB shall have the right but not the obligation to seek extensions of the terms of any Secured Patents, at SB's expense. SB shall have sole discretion in making any decisions related to such expenses. 11.8.4 ACTIONS SUBSEQUENT TO TERMINATION. In the event of a termination of this Agreement at a time when SB has foreclosed on the Secured Patents (whether such termination occurred before or after such foreclosure), then: (a) In the event of the institution of any suit by a THIRD PARTY against Coulter, SB, or any sublicensee or distributor of either of them for patent infringement involving the manufacture, use, sale, distribution or marketing of PRODUCT anywhere in the TERRITORY or Japan, the Party sued shall promptly notify the other Party in writing. Each Party shall have the right to defend itself in such action, at its own expense, and the Parties shall reasonably cooperate in any such litigation without expense to the requesting Party. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 93. 107 (b) In the event that either Party becomes aware of actual or threatened infringement of a Secured Patent anywhere in the TERRITORY or Japan, the Party becoming aware of such matter shall promptly inform the other Party. SB shall have the first right, but not the obligation, to bring, at its own expense, an infringement action against any such apparent infringer, and if necessary to name Coulter as a party in such action, unless the actual or threatened infringement is exclusively within the scope of Coulter's exclusive license rights under Section 3(a) of the Security Agreement, and the outcome of such action can not potentially affect the validity or enforceability of such Secured Patent with respect to the field of ANTI-CD20 ANTIBODIES, in which case Coulter shall have the first right to bring such an action and if necessary to name SB as a party in such action. If the Party with the first right to commence such an action does not do so within ninety (90) days of delivery or receipt of the notice of infringement, the other Party, after notifying the first Party in writing, shall be entitled to bring such infringement action at its own expense. The Party conducting such action shall have full control over its conduct, including settlement thereof subject to paragraph (d) below. In any event, the Parties shall reasonably cooperate in any such litigation without expense to the requesting Party. (c) Coulter and SB shall recover their respective actual OUT-OF-POCKET COSTS, or equitable proportions thereof, from the proceeds of any litigation recovery or settlement under this Section 11.8.4. Any amount recovered in excess of such costs shall be retained by the Party conducting the action. (d) The Parties shall keep one another informed of the status of and their respective activities regarding any litigation or settlement thereof concerning Secured Patents, provided, however, that no settlement or consent judgment or other voluntary final disposition of any suit defended or action brought by a Party pursuant to this Section 11.8 may be entered into without the consent of the other Party if such settlement would require the other Party to be subject to an injunction or to make a monetary payment or would otherwise adversely affect the other Party's rights. 11.8.5 NO REPRESENTATION OR WARRANTY. SB makes no representation or warranty, express or implied, with respect to any of SB's activities related to the Secured Patents. Coulter agrees that SB shall have no liability to Coulter with respect to SB's activities related to the Secured Patents provided that SB follows the procedures outlined in this Section 11.8. 11.9 COVENANT REGARDING EXISTING THIRD PARTY LICENSE AGREEMENTS WITH [*]. Coulter covenants that as of the date of mutual execution of this Agreement by the Parties, it will expeditiously pursue and use COMMERCIALLY REASONABLE EFFORTS to obtain an amendment(s) of the EXISTING THIRD PARTY LICENSE AGREEMENTS with [*] (as defined in Section [*]) in order that: 11.9.1 [*] shall waive any right that it has under its EXISTING THIRD PARTY LICENSE AGREEMENTS with Coulter to participate in any decisions regarding the settlement, consent judgment or other voluntary final disposition of any suit regarding any COULTER PATENT RIGHTS which may be owned by [*]; and [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 94. 108 11.9.2 the licenses granted to Coulter by [*] under the first of the two EXISTING THIRD PARTY LICENSE AGREEMENTS between Coulter and [*] (as set forth in Section 1.19(v)) will be consistent in scope with the licenses granted to Coulter by [*] under the second of the two EXISTING THIRD PARTY LICENSE AGREEMENTS between Coulter and [*] (as set forth in Section 1.19(vi)). Coulter agrees to keep SB informed of its efforts to negotiate the amendment(s) described in Sections 11.9.1 and 11.92. Coulter provides no assurance to SB that such amendment(s) will be obtained despite its efforts to do so, provided that (a) in the event such amendments are not obtained, Coulter will bear, at its sole expense, any incremental royalties, licensing fees and legal costs incurred by the Parties with respect to the making, having made, use or sale of PRODUCT in the TERRITORY as a result thereof, or (b) in the event such amendment is obtained, but requires any incremental royalties, licensing fees and legal costs relating to the making, having made, use or sale of PRODUCT in the TERRITORY, Coulter will bear, at its sole expense, any such incremental royalties, licensing fees and legal costs. ARTICLE 12 FORCE MAJEURE Neither Party shall be liable to the other for delay or failure in the performance of the obligations on its part contained in this Agreement if and to the extent that such failure or delay is due to circumstances beyond its control which it could not have avoided by the exercise of reasonable diligence (a "FORCE MAJEURE OCCURRENCE") including but not limited to: act of God, war or insurrection; civil commotion; destruction of essential facilities or materials by earthquake, fire, flood or storm; labor disturbance; epidemic; or other similar event; provided, however, that the Party so affected shall notify the other Party promptly should such circumstances arise, giving an indication of the likely extent and duration thereof, and shall use all COMMERCIALLY REASONABLE EFFORTS to avoid, remove or alleviate such causes of nonperformance and shall resume performance of its obligations hereunder with the utmost dispatch whenever such causes are removed. ARTICLE 13 TERM AND TERMINATION 13.1 TERM. 13.1.1 Unless earlier terminated as set out in this Agreement, this Agreement shall expire in TERRITORY A with respect to a particular PRODUCT upon the termination of the sale of such PRODUCT in TERRITORY A and the availability of such PRODUCT for the end user, such termination to be determined by the JCC. Following such expiration, neither Party shall have any rights under the other Party's INTELLECTUAL PROPERTY RIGHTS in TERRITORY A to make, have made, use, sell, offer for sale, and import such PRODUCT in TERRITORY A, and, unless agreed otherwise by the Parties, both Parties shall be precluded from selling such PRODUCT in TERRITORY A, or from licensing or otherwise enabling any AFFILIATE or THIRD PARTY to sell such PRODUCT in [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 95. 109 TERRITORY A. Furthermore, following such expiration, while Coulter shall retain all rights to the Territory A Trademarks (as defined in Section 10.1.1) related to such PRODUCT, unless agreed otherwise by the Parties, Coulter shall be precluded from using such Territory A Trademarks in connection with the making, having made, use, sale, offer for sale, and importation of such PRODUCT or any other human pharmaceutical therapy in TERRITORY A. This Agreement shall expire in its entirety in TERRITORY A upon the termination of sale of all PRODUCTS in TERRITORY A. 13.1.2 Unless earlier terminated as set out in this Agreement, this Agreement shall expire in each country of TERRITORY B and TERRITORY C with respect to a particular PRODUCT on a country-by-country basis, on the [*] anniversary of the date of FIRST COMMERCIAL SALE of such PRODUCT in such country. Following such expiration in a particular country of TERRITORY B and TERRITORY C, each Party shall have a non-exclusive, royalty-free, irrevocable and perpetual license, under the other Party's INTELLECTUAL PROPERTY RIGHTS in such country, to make, have made, use, sell, offer for sale, and import such PRODUCT in such country, except that Coulter shall have no rights to any INTELLECTUAL PROPERTY RIGHTS or INVENTIONS or other proprietary know-how of SB related to the [*] developed [*] the [*]. Furthermore, following such expiration, SB shall have the exclusive right to use the TRADEMARK used in connection with such PRODUCT in connection with the making, having made, use, sale, offer for sale, and importation of the PRODUCT in such country, and if such TRADEMARK is a Coulter Trademark (as defined in Section 10.1.2), Coulter shall promptly assign all rights and title to such TRADEMARK in such country to SB. Coulter warrants and represents that after such expiration, Coulter shall no longer use Trademark (whether an SB Trademark (as defined in Section 10.1.2) or Coulter Trademark) for any purpose, and shall only be permitted to continue to sell such PRODUCT under a trademark which is not confusingly similar to Trademark. This Agreement shall expire in its entirety in a particular country of TERRITORY B or TERRITORY C upon the termination of the fifteenth anniversary of the FIRST COMMERCIAL SALE of the last PRODUCT in such country. 13.1.3 With respect to supply of a particular PRODUCT to the Parties after the expiration of the Agreement in TERRITORY B and TERRITORY C with respect to such PRODUCT, the Parties shall meet [*] months prior to the expiration date for the first country under Section 13.1.2 in TERRITORY B, and again [*] prior to the expiration date for the first country under Section 13.1.2 in TERRITORY C, to discuss an ongoing long-term agreement for the supply of the relevant UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY from whichever Party is then manufacturing UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY (whether at its own facilities or at a THIRD PARTY manufacturer) to the other Party in each such TERRITORY. If the Parties are unable to agree on a long-term supply agreement within six (6) months prior to the first expiration date in any such TERRITORY, the then supplying Party would be obligated to supply the other Party with UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY in such TERRITORY for [*] following the date of first expiration in such TERRITORY, such supply to be charged to the receiving Party at the supplying Party's COST OF GOODS plus a percentage of such Party's COST OF GOODS to be negotiated in good faith between the Parties, provided in no event shall such percentage exceed [*]. After such [*], each Party shall be free to contract with any THIRD PARTY manufacturer for the supply of UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY, provided that neither SB nor Coulter may enter into an exclusivity agreement with a [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 96. 110 THIRD PARTY manufacturer for the supply of UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY which would preclude the other Party from being supplied by the same manufacturer. 13.2 GENERAL CONDITIONS OF EXPIRATION AND TERMINATION. 13.2.1 The provisions of Sections 8.1, 8.2, 8.3, 8.5, 8.6, 8.7, 9.18, 10.1.1, 10.1.2, 10.2.3, 10.5 (to the extent related to actions which arose during the term of the Agreement), 10.6 (to the extent related to actions which arose during the term of the Agreement), 10.7, 11.1, 11.1.2 (with respect to jointly-owned INVENTIONS), 11.2 (with respect to jointly-owned INVENTIONS), 11.3 (to the extent related to actions which arose during the term of the Agreement), 11.4 (to the extent related to actions which arose during the term of the Agreement), 11.5 (to the extent related to actions which arose during the term of the Agreement), 11.6 (to the extent related to actions which arose during the term of the Agreement), 11.8 and 11.9 and Articles 12, 13, 14, 15, 16, 17, 18 and 19 (excluding Section 19.1) shall survive termination or expiration of this Agreement. 13.2.2 Termination or expiration of this Agreement shall not operate to deprive either Party of any rights or remedies either at law or in equity or to relieve either Party of any of its obligations incurred prior to the effective date of such termination or expiration. 13.2.3 SB may terminate this Agreement on a country by country basis by giving Coulter at least [*] written notice thereof at any time before SB first markets PRODUCT in such country based on a reasonable determination by SB, using the same standards SB would use in assessing whether or not to continue development or commercialization of a PRODUCT of its own making, that the patent, medical/scientific, technical, regulatory or commercial profile of PRODUCT does not justify continued development or future commercialization of PRODUCT in such country. After marketing PRODUCT, SB may terminate this Agreement on a country by country basis by giving Coulter at least [*] prior written notice thereof based on a reasonable determination by SB, using the same standards SB would use in assessing whether or not to continue development or commercialization of a PRODUCT of its own making, that the patent, medical/scientific, technical, regulatory or commercial profile of PRODUCT does not justify continued marketing of PRODUCT in such country. If SB terminates this Agreement pursuant to this Section 13.2.3, it shall pay to Coulter (i) in the event that Coulter is continuing with the development or commercialization of PRODUCT in such country(ies) in which SB is terminating the Agreement, all sums accrued under this Agreement which are then due and owing by SB to Coulter in such country(ies) (less any sums which are then due and owing by Coulter to SB in such country(ies)) for [*], as applicable, up to the effective date of termination, or (ii) in the event that Coulter determines within such [*] as the case may be that Coulter will not continue with the development or commercialization of PRODUCT in such country(ies) in which SB is terminating the Agreement, [*] of all unavoidable and noncancellable OUT-OF-POCKET COSTS which are reasonably associated with winding down the development or commercialization of PRODUCT in such country(ies). In the event that SB terminates this Agreement in one or more countries and becomes liable under clause (ii) hereto, then the Parties shall consult in good faith regarding the costs associated with winding down such development and commercialization of PRODUCT and [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 97. 111 the tasks to be undertaken by the Parties, and agree to use COMMERCIALLY REASONABLE EFFORTS to minimize such costs. 13.2.4 Either Party may terminate this Agreement if, at any time, the other Party shall file in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of the Party or of its assets, or if the other Party proposes a written agreement of composition or extension of its debts, or if the other Party shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed within sixty (60) days after the filing thereof, or if the other Party shall propose or be a Party to any dissolution or liquidation, or if the other Party shall make an assignment for the benefit of creditors. 13.2.5 Notwithstanding the bankruptcy of Coulter, or the impairment of performance by Coulter of its obligations under this Agreement as a result of bankruptcy or insolvency of Coulter, SB shall be entitled to retain the licenses granted herein, subject to Coulter's rights to terminate this Agreement for reasons other than bankruptcy or insolvency as expressly provided in this Agreement. 13.2.6 All rights and distribution rights granted under or pursuant to this Agreement by Coulter to SB are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to "intellectual property" as defined under Section 101(52) of the U.S. Bankruptcy Code. The Parties agree that SB, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code, subject to performance by SB of its preexisting obligations under this Agreement. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against Coulter under the U.S. Bankruptcy Code, SB shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, and same, if not already in its possession, shall be promptly delivered to SB (a) upon any such commencement of a bankruptcy proceeding upon written request therefor by SB, unless Coulter elects to continue to perform all of its obligations under this Agreement, or (b) if not delivered under (a) above, upon the rejection of this Agreement by or on behalf of Coulter upon written request therefor by SB, provided, however, that upon Coulter's (or its successor's) written notification to SB that it is again willing and able to perform all of its obligations under this Agreement, SB shall promptly return all such tangible materials to Coulter, but only to the extent that SB does not require continued access to such materials to enable SB to perform its obligations under this Agreement. 13.3 TERMINATION FOR BREACH. 13.3.1 GENERAL. Except as otherwise provided in this Section 13.3.1, either Party may terminate this Agreement for material breach by the other Party, which breach remains uncured for [*] days in the case of nonpayment of any amount due and [*] days for all other breaches, each measured from the date written notice of such breach is given to the breaching Party, or, if such breach is not susceptible of cure within such [*] day period and the breaching [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 98. 112 Party uses diligent good faith efforts to cure such breach, for [*] days after written notice to the breaching Party, provided that notice of termination must be given after the date written notice of breach is given and prior to the expiration of such [*] period and prior to the cure of the breach by the breaching Party. 13.3.2 BREACH BY SB. If termination is due to a material breach by SB, all rights granted to SB under this Agreement shall revert to Coulter and Coulter shall automatically be granted an exclusive, worldwide, royalty-free license, with a right to sublicense, under all INTELLECTUAL PROPERTY RIGHTS held by SB at the time of termination, to use, sell, offer for sale and import the PRODUCT in the FIELD in the TERRITORY, but Coulter shall have no rights under any INTELLECTUAL PROPERTY RIGHTS or INVENTIONS or other proprietary know-how held by SB which are related to the [*], and the terms of Section 13.4 shall apply. Coulter shall thereafter be free to develop and commercialize the PRODUCT without limitation or further obligation to SB. 13.4 EARLY TERMINATION LICENSE OF SB'S LICENSE. In the event SB's license terminates early in one or more countries pursuant to Section 3.2.5(b), 5.4.1(a), 5.4.2(a), 6.7, 7.2.2(a), 7.2.2(b), 9.10.4, 9.10.6, 13.2.3 or 13.3.2 all rights granted to SB under this Agreement in such countries shall revert to Coulter and Coulter shall automatically be granted an exclusive license, with a right to sublicense, under all INTELLECTUAL PROPERTY RIGHTS held by SB at the time of termination in such countries, to use, sell, offer for sale and import the PRODUCT in the FIELD in such countries, except that Coulter shall have no rights to any INTELLECTUAL PROPERTY RIGHTS or INVENTIONS or other proprietary know-how of [*] developed [*] the [*]. In addition, at Coulter's election, either (i) SB will transfer to Coulter any regulatory filings made by SB or its permitted sublicensees in such countries or (ii) Coulter and/or its THIRD PARTY licensees will have a right of reference to any regulatory filings made by SB or its permitted sublicensees in such countries to the extent legally permitted. Coulter shall thereafter be free to develop and commercialize the Product without limitation or further obligation to SB in such countries, except as otherwise provided in this Section 13.4. In addition, SB shall promptly provide Coulter, with the SB Transfer Documents (as defined below), which Coulter may use as Coulter sees fit and which Coulter may provide to a THIRD PARTY licensee for use in continuing DEVELOPMENT and commercialization of the PRODUCT in the FIELD in such countries. Coulter shall reimburse SB for all expenses incurred by SB in the provision of such Transfer Documents to Coulter within thirty (30) days after receipt of SB's invoice therefor. For purposes of this Section 13.4 and Section 13.5, "SB Transfer Documents" shall mean [*], including but not limited to the following documents: (i) [*]; (ii) [*]; (iii) [*], and (iv) [*]. Notwithstanding the above, it is understood that in the event that SB's exclusive license is terminated in less than the entire European Union, and European Union regulatory or other governmental regulations require a single company to hold a centralized marketing authorization license for PRODUCT, SB will still be the marketing authorization holder of the original centralized license, to which Coulter and/or its sublicensee shall have a right of reference, and such original centralized license will continue to be valid throughout the whole of the European Union, and Coulter or its sublicensee will be required to obtain a second centralized license which will be valid throughout the whole of the European Union, and neither Coulter nor its sublicensee will be permitted to market PRODUCT under the TRADEMARK. However, neither [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 99. 113 Coulter nor its THIRD PARTY licensees shall be permitted to market, sell or distribute PRODUCT under such second centralized license in those countries of the European Union in which SB's license remains exclusive, provided that the foregoing shall not be construed to otherwise limit further sale of PRODUCT put on sale in those countries of the European Union in which Coulter and/or its sublicensee are permitted to market PRODUCT into the other countries of the European Union. 13.5 NON-EXCLUSIVE LICENSE. In the event SB's license becomes non-exclusive in one or more countries pursuant to Section 5.4.1(a), 5.4.2(a), 7.2.2(a), 7.2.2(b) or 9.10.4, all rights granted to SB under this Agreement in such countries shall become non-exclusive and Coulter shall automatically be granted a non-exclusive license, with a right to sublicense, under all INTELLECTUAL PROPERTY RIGHTS held by SB at the time SB's license becomes non-exclusive in such countries, to use, sell, offer for sale and import the PRODUCT in the FIELD in such countries, except that Coulter shall have no rights to any INTELLECTUAL PROPERTY RIGHTS or INVENTIONS or other proprietary know-how of SB related to the [*] developed [*] the [*]. In the event SB's license becomes non-exclusive in one or more countries pursuant to Section 7.2.2(a) or 7.2.2(b), Coulter may only grant a sublicense under the foregoing license to sell PRODUCT to a single THIRD PARTY in any given country. In addition, Coulter and/or its THIRD PARTY licensees will have a right of reference to any regulatory filings made by SB or its permitted sublicensees in such countries to the extent legally permitted. Coulter shall thereafter be free to develop and commercialize the Product without limitation or further obligation to SB in such countries except as otherwise provided in this Section 13.5. In addition, SB shall promptly provide Coulter with the SB Transfer Documents (as defined in Section 13.4), which Coulter may use as Coulter sees fit and which Coulter may provide to a THIRD PARTY licensee for use in continuing development and commercialization of the PRODUCT in the FIELD in such countries. Coulter shall reimburse SB for all expenses incurred by SB in the provision of such SB Transfer Documents to Coulter within [*] after receipt of SB's invoice therefor. Notwithstanding the above, it is understood that in the event that SB's exclusive license is converted to a non-exclusive license in less than the entire European Union, and European Union regulatory or other governmental regulations require a single company to hold a centralized marketing authorization license for PRODUCT, SB will still be the marketing authorization holder of the original centralized license, to which Coulter and/or its sublicensee shall have a right of reference, and such original centralized license will continue to be valid throughout the whole of the European Union, and Coulter or its sublicensee will be required to obtain a second centralized license which will be valid throughout the whole of the European Union, neither Coulter nor its sublicensee will be permitted to market PRODUCT under the Trademark. However, neither Coulter nor its THIRD PARTY licensees shall be permitted to market, sell or distribute PRODUCT under such second centralized license in those countries of the European Union in which SB's license remains exclusive, provided that the foregoing shall not be construed to otherwise limit further sale of PRODUCT put on sale in those countries of the European Union in which Coulter and/or its sublicensee are permitted to market PRODUCT into the other countries of the European Union. 13.6 EARLY TERMINATION OF COULTER'S LICENSE. In the event Coulter's rights to CO-PROMOTE PRODUCT terminates early in TERRITORY A pursuant to Sections 4.2.3, 5.4.1(b), 5.4.2(b) or 7.1.15 (third sentence), all rights granted to Coulter under this Agreement in TERRITORY A shall [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 100. 114 revert to SB, and SB shall automatically be granted an exclusive license, with a right to sublicense, under all INTELLECTUAL PROPERTY RIGHTS held by Coulter at the time of termination in TERRITORY A, to use, sell, offer for sale and import the PRODUCT in the FIELD in TERRITORY A. In addition, SB and/or its THIRD PARTY licensees will have a right of reference to any regulatory filings made by Coulter or its permitted sublicensees in TERRITORY A to the extent legally permitted. SB shall thereafter be free to commercialize the PRODUCT in TERRITORY A, and to use the Coulter Trademark (as defined in Section 10.1.2) in connection therewith, without limitation or further obligation to Coulter in TERRITORY A, except as otherwise provided in this Section 13.6 or Section 7.1.15. In addition, Coulter shall promptly provide SB with the Coulter Transfer Documents (as defined below) to the extent SB does not already have such Coulter Transfer Documents, which SB may use as SB sees fit and which SB may provide to a THIRD PARTY licensee for use in continuing commercialization of the PRODUCT in the FIELD in TERRITORY A. SB shall reimburse Coulter for all expenses incurred by Coulter in the provision of such Coulter Transfer Documents to Sb within thirty (30) days after receipt of Coulter's invoice therefor. For purposes of this Section 13.6, "Coulter Transfer Documents" shall mean all Coulter KNOW-HOW, including but not limited to the following documents: (i) a copy of all protocols prepared by Coulter and regulatory filings made by Coulter under this Agreement in TERRITORY A; (ii) a copy of all reports on non-clinical and clinical studies sponsored by Coulter in TERRITORY A or for the benefit of TERRITORY A under this Agreement which have been filed or prepared for filing with the regulatory authorities; (iii) the data underlying any non-clinical and clinical database owned by Coulter in computer-readable form if readily available in a non-proprietary format, and (iv) a copy of all case report forms for patients enrolled in clinical studies sponsored by Coulter for which no report has been prepared at the time of termination. 13.7 NO LIMIT ON REMEDIES. Nothing herein shall exclude or limit any remedies or entitlements whatsoever which the law confers to either Party in the event of a breach of contractual obligations by the other Party. ARTICLE 14 ASSIGNMENT 14.1 ASSIGNMENT. Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other which shall not be unreasonably withheld, except a Party may make such an assignment without the other Party's consent to Affiliates or to a successor to substantially all of the pharmaceutical business of such Party, whether in a merger, sale of stock, sale of assets or other transaction. Any permitted successor or assignee of rights and/or obligations hereunder shall, in a writing to the other Party, expressly assume performance of such rights and/or obligations. Any permitted assignment shall be binding on and inure to the benefit of the successors of the assigning Party. Any assignment or attempted assignment by either Party in violation of the terms of this Section 14.1 shall be null and void and of no legal effect. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 101. 115 14.2 PERFORMANCE BY AFFILIATES AND LOCAL OPERATING ENTITIES. Each of Coulter and SB acknowledge that obligations under this Agreement may be performed by AFFILIATES of Coulter and SB, to the extent permitted by this Agreement. Each of Coulter and SB guarantee performance of this Agreement by its AFFILIATES. In the event of a claim arising under this Agreement with respect to an AFFILIATE of the other Party, the aggrieved Party may seek a remedy directly against the other Party and shall not be required to seek a remedy from the other Party's AFFILIATE. Wherever, as permitted by this Agreement, the Parties delegate responsibility to local operating entities, the Parties agree that such entities have no authority to amend the terms of this Agreement or act contrary to its terms in any way. ARTICLE 15 INDEMNIFICATION AND INSURANCE 15.1 CROSS INDEMNIFICATION. 15.1.1 INDEMNIFICATION IN THE NON-USA TERRITORY. (a) With respect to DEVELOPMENT, MANUFACTURE DEVELOPMENT, manufacture or commercialization of PRODUCT sold or to be sold in TERRITORY B or TERRITORY C, SB hereby agrees to save, defend and hold Coulter, its AFFILIATES and their respective officers, directors, shareholders, representatives, agents, employees, successors and assigns harmless from and against any and all suits, claims, actions, demands, liabilities, expenses and/or losses, including reasonable legal expense and attorneys' fees, brought by a THIRD PARTY or that arise in connection with any claim brought by a THIRD PARTY with respect to the PRODUCT ("Losses"), including without limitation, Losses resulting from inherent defects in the PRODUCT, except to the extent such Losses result from (i) the negligence or willful misconduct of Coulter or breach by Coulter of any provision of this Agreement, including without limitation, the Coulter warranties and representations set forth in Article 16 or (ii) Coulter's manufacture (including its manufacture through THIRD PARTY suppliers) of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY which does not comply with GMP or PRODUCT specifications (as defined in Section 9.4.4), except to the extent such Losses result from (x) the negligence or willful misconduct of SB or breach by SB of any provision of this Agreement, including without limitation, the SB warranties and representations set forth in Article 16 or (y) SB's manufacture (including its manufacture through THIRD PARTY suppliers) of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY which does not comply with GMP or PRODUCT Specifications (as defined in Section 9.4.4). (b) With respect to DEVELOPMENT, MANUFACTURE DEVELOPMENT, manufacture or commercialization of PRODUCT sold or to be sold in TERRITORY B or TERRITORY C Coulter hereby agrees to save, defend and hold SB, its AFFILIATES and their respective officers, directors, shareholders, representatives, agents, employees, successors and assigns harmless from and against any and all Losses (as defined in Section 15.1.1(a)) with respect to the PRODUCT to the extent such Losses result from (i) the negligence or willful misconduct of Coulter or breach by Coulter of any provisions of this Agreement, including without limitation, the SB warranties [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 102. 116 and representations set forth in Article 16 or (ii) Coulter's manufacture (including its manufacture through THIRD PARTY suppliers) of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY which does not comply with GMP or PRODUCT Specifications (as defined in Section 9.4.4), except to the extent such Losses result from (x) the negligence or willful misconduct of SB or breach by SB of any provision of this Agreement, including without limitation, the SB warranties and representations set forth in Article 16 or (y) SB's manufacture (including its manufacture through THIRD PARTY suppliers) of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY which does not comply with GMP or PRODUCT Specifications (as defined in Section 9.4.4). 15.1.2 INDEMNIFICATION IN TERRITORY A. With respect to DEVELOPMENT, MANUFACTURE DEVELOPMENT, manufacture or commercialization of PRODUCT sold or to be sold in TERRITORY A, each Party hereby agrees to save, defend and hold the other Party, its AFFILIATES and their respective officers, directors, shareholders, representatives, agents, employees, successors and assigns harmless from and against any and all Losses (as defined in Section 15.1.1(a)) resulting directly from the manufacture, use, handling, storage, sale or other disposition of Products throughout Territory A to the extent such Losses result from (i) the negligence or willful misconduct of the indemnifying Party or breach by the indemnifying Party of any provision of this Agreement, including without limitation, the warranties and representations set forth in Article 16 (ii) a Party's manufacture (including its manufacture through THIRD PARTY suppliers) of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY which does not comply with GMP or PRODUCT Specifications (as defined in Section 9.4.4), or (iii) marketing activities of the indemnifying Party contrary to applicable governmental regulations or outside the approved labeling of the PRODUCT, except to the extent such Losses result from (x) the negligence or willful misconduct of the other Party or breach by the other Party of any provision of this Agreement, including without limitation, the other Party's warranties and representations set forth in Article 16 or (y) the other Party's manufacture (including its manufacture through THIRD PARTY suppliers) of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY which does not comply with GMP or PRODUCT Specifications (as defined in Section 9.4.4). Any other Losses resulting directly from the manufacture, use, handling, storage, sale or other disposition of PRODUCTS throughout TERRITORY A, including Losses resulting from inherent defects in the PRODUCT, shall be included as an OTHER OPERATING INCOME/EXPENSE and included in the JOINT P&L as outlined in Section 7.1.14. 15.2 INDEMNIFICATION PROCEDURE. 15.2.1 In the event Coulter is seeking indemnification from SB under Section 15.1.1(a) or 15.1.2, SB shall have no such obligation unless Coulter: (a) gives SB prompt notice of any claim or lawsuit or other action for which it seeks to be indemnified under this Agreement; (b) cooperates fully with SB and its agents in defense of any such claim, complaint, lawsuit or other cause of action; and [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 103. 117 (c) SB is granted full authority and control over the defense, including settlement or other disposition thereof, against such claim or lawsuit or other action, provided that Coulter shall have the right to retain counsel of its choice to participate in the defense of any such claim or lawsuit at Coulter's own expense, provided that such counsel shall not interfere with SB's full authority and control. 15.2.2 In the event SB is seeking indemnification under Section 15.1.1(b) or Section 15.1.2, Coulter shall have no such obligation unless SB: (a) gives Coulter prompt notice of any claim or lawsuit or other action for which it seeks to be indemnified under this Agreement; (b) cooperates fully with Coulter and its agents in defense of any such claim, complaint, lawsuit or other cause of action; and (c) Coulter is granted full authority and control over the defense, including settlement or other disposition thereof, against such claim or lawsuit or other action, provided that SB shall have the right to retain counsel of its choice to participate in the defense of any such claim or lawsuit at SB's own expense, provided that such counsel shall not interfere with Coulter's full authority and control. 15.3 INSURANCE. During the term of the Agreement, and for a period of five (5) years after the expiration or termination of this Agreement or the earlier termination thereof, each Party shall maintain, respectively, at its sole cost and expense, and in the case of Coulter, from insurance companies having a rating of at least "A-VIII" as published in the most recent edition of A.M. Best's Insurance Reports, product liability insurance and contractual liability coverage, in amounts, respectively, which are reasonable and customary in the U.S. pharmaceutical industry for companies of comparable size and activities at the respective place of business of each Party. Such product liability insurance shall insure against all liability, including personal injury, physical injury, or property damage arising out of the manufacture, sale, distribution, or marketing of PRODUCT in the countries of the world in which the Party is permitted to undertake such activities in accordance with this Agreement. Each Party shall provide written proof of the existence of such insurance to the other Party upon request. Notwithstanding the foregoing, prior to FIRST COMMERCIAL SALE each Party shall always maintain product liability insurance with a minimum of [*] per occurrence (or claim) and annual aggregate limit of liability, and after FIRST COMMERCIAL SALE each Party shall always maintain product liability insurance with a minimum of [*] per occurrence (or claim) and annual aggregate limit of liability. The cost of obtaining and maintaining such insurance shall not be an allowable expense under the JOINT P&L described in Section 7.1.14. ARTICLE 16 WARRANTIES AND REPRESENTATIONS 16.1 Each Party hereby warrants to the other: [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 104. 118 16.1.1 that it has full power and authority to execute and deliver this Agreement, the STOCK PURCHASE AGREEMENT, and the LOAN AGREEMENT and to perform the obligations on its part under such agreements; 16.1.2 that the execution and delivery by it of this Agreement, the STOCK PURCHASE AGREEMENT and the LOAN AGREEMENT and the performance of its obligations under such agreements (i) have been duly approved by all necessary corporate action and do not require any shareholder action or approval; (ii) do not and will not conflict with or result in a material breach of any of the terms and provisions of any THIRD PARTY agreement entered into as of the Effective Date; and (iii) do not and will not conflict with such Party's Certificate of Incorporation or By-Laws; 16.1.3 that it has the right to grant the licenses outlined in this Agreement, and is not aware of any impediment, including without limitation any THIRD PARTY agreement, which would prevent it from performing its obligations under this Agreement; and 16.1.4 that it will not enter into any THIRD PARTY agreement after the Effective Date which, in any way, will limit its ability to perform all of the obligations undertaken by it hereunder. 16.2 Coulter warrants and represents that it: 16.2.1 as of the Effective Date will have received any consent required from Dana Farber Cancer Institute, Inc., a Massachusetts non-profit corporation, with its principal place of business at 44 Binney Street, Boston, Massachusetts, 02115 (hereinafter, "Dana Farber"), InterWest Partners V.L.P and InterWest Investors V (hereinafter collectively, "InterWest Partners"), the University of Michigan, a constitutional corporation of the State of Michigan, with offices located at 3003 South State, Room 2071, Ann Arbor, Michigan 48109-1280 (hereinafter, "Michigan") and any other THIRD PARTY to grant the licenses under Article 5 according to the terms thereof and to perform its obligations to SB under this Agreement; 16.2.2 as of the Effective Date will have obtained a waiver of each and every obligation imposed by Dana Farber, InterWest Partners, Michigan and any other THIRD PARTY (including, without limitation, the United States Government) to manufacture PRODUCT substantially in the United States of America consistent with federal law and policy, or in the event that such waivers have not been obtained by the Effective Date, it will expeditiously pursue, and use COMMERCIALLY REASONABLE EFFORTS to provide assistance to any THIRD PARTY making application for, such waivers; 16.2.3 shall pay all royalties or other sums and other payments which Coulter may owe to Dana Farber, InterWest Partners, Michigan and any other THIRD PARTY by virtue of this Agreement (all subject to the cost-sharing mechanisms set forth in this Agreement), and shall perform and observe all of the other obligations outlined in all present and future agreements between Coulter and Dana Farber, InterWest Partners, Michigan and any other THIRD PARTY which are in any way related to Coulter's ability to grant the rights granted to SB [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 105. 119 under this Agreement or to Coulter's ability to perform its obligations to SB under this Agreement; and 16.2.4 has received no notices that Coulter is in breach of its obligations under its agreements with Dana Farber, InterWest Partners, Michigan or any other THIRD PARTY which are in any way related to Coulter's ability to grant the rights granted to SB under this Agreement or to Coulter's ability to perform its obligations to SB under this Agreement. In the event that Coulter receives notice from Dana Farber, InterWest Partners, Michigan or any other THIRD PARTY that Coulter has committed a breach of its obligations under any such agreement, or if Coulter anticipates such breach, such as may give rise to a right by such THIRD PARTY to terminate, diminish Coulter's ability to grant rights to SB contemplated by this Agreement, or otherwise diminish Coulter's ability to perform its obligations to SB under this Agreement, Coulter shall immediately notify SB of such situation, and Coulter shall promptly cure such breach. However, if Coulter is unable to cure such breach, Coulter shall, to the extent possible, permit SB to cure such breach and to negotiate directly with such THIRD PARTY. 16.3 Coulter warrants and represents that it has disclosed to SB the complete texts of all COULTER PATENT RIGHTS as of the Effective Date as well as all information received by Coulter as of the Effective Date concerning the institution or possible institution of any interference, opposition, reexamination, reissue, revocation, nullification or any official proceeding involving a COULTER PATENT RIGHT anywhere in the TERRITORY. Coulter hereby warrants and represents that it has no present knowledge that the COULTER PATENT RIGHTS are invalid or unenforceable. 16.4 Coulter warrants and represents that, to the best of its knowledge, information related to the PRODUCT it has provided to SB prior to the Effective Date is up-to-date, timely and accurate in all material respects. Coulter further warrants and represents that it has not, up through and including the Effective Date, omitted to furnish SB with any material information available to Coulter concerning the PRODUCT. 16.5 Coulter warrants and represents that it will not knowingly engage in any activity regarding DEVELOPMENT or MANUFACTURE DEVELOPMENT or commercialization of PRODUCT outside of the FIELD, including, but not limited to, publication of preclinical or clinical data related to PRODUCT, which is or ought to be recognized by Coulter as posing a present or potential harm to the DEVELOPMENT or MANUFACTURE DEVELOPMENT or commercialization of PRODUCT within the FIELD. 16.6 SB warrants and represents that it has the full right and authority to enter into this Agreement and that it is not aware of any impediment, including without limitation any THIRD PARTY agreement, which would prevent it from performing its obligations under this Agreement. 16.7 SB warrants and represents that it has reviewed the information furnished to SB by Coulter regarding PRODUCT before deciding whether to enter into this Agreement. [*] to [*] the [*] to the [*] to [*]. 16.8 EXCEPT FOR THE EXPRESS WARRANTIES AND REPRESENTATIONS CONTAINED IN THIS AGREEMENT, NEITHER SB NOR COULTER MAKES ANY [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 106. 120 OTHER WARRANTIES OR REPRESENTATIONS, EXPRESS OR IMPLIED, IN FACT OR IN LAW. ARTICLE 17 CONFIDENTIAL INFORMATION 17.1 INFORMATION. Each Party shall keep all information received from the other Party (the "Information") confidential and shall not disclose nor use the Information without the other Party's written consent except to the extent contemplated by this Agreement. This restriction shall not, however, prevent disclosure of the Information if and to the extent that disclosure is required by law, provided that the disclosing Party informs the other Party without delay of any such requirement, in order to allow such other Party to object to such disclosure and to seek an appropriate protective order or similar protection prior to disclosure. 17.2 EXCEPTIONS. The above obligations shall not apply or shall cease to apply to Information which: 17.2.1 is now, or hereafter becomes, through no act or failure to act on the part of the receiving Party, generally known or available; 17.2.2 is known by the receiving Party at the time of receiving such information, as evidenced by its written records; 17.2.3 is hereafter furnished to the receiving Party by a THIRD PARTY, as a matter of right and without restriction on disclosure; 17.2.4 is independently developed by or for the receiving Party without any breach of this Article 17; or 17.2.5 is the subject of a written permission to disclose provided by the disclosing Party. 17.3 PERMITTED DISCLOSURES. Information may be disclosed to employees, agents or consultants of the receiving Party or its AFFILIATES or sublicensees or suppliers of LICENSED COMPOUNDS and PRODUCTS, but only to the extent required to accomplish the purposes of this Agreement and only if the receiving Party obtains prior agreement from its employees, agents, consultants, sublicensees or suppliers to whom disclosure is to be made to hold in confidence and not make use of such Information for any purpose other than those permitted by this Agreement. Each Party will use at least the same standard of care as it uses to protect proprietary or confidential information of its own to ensure that such employees, agents, consultants, sublicensees or suppliers do not disclose or make any unauthorized use of the Information. 17.4 DISCLOSURE OF AGREEMENT. Neither Coulter nor SB shall release to any THIRD PARTY or publish in any way any non-public information with respect to the terms of this Agreement or concerning their cooperation without the prior written consent of the other and [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 107. 121 agreement upon the nature and text of such announcement or disclosure, which consent will not be unreasonably withheld or delayed; provided; however that either Party may disclose the terms of this Agreement to the extent required to comply with applicable laws, including without limitation the rules and regulations promulgated by the Securities and Exchange Commission and the Party intending to disclose the terms of this Agreement shall provide the nondisclosing Party an opportunity to review and comment on the intended disclosure in reasonably sufficient time (such time period to depend on the urgency of the intended disclosure) prior to public release, and shall provide the other Party with a written copy thereof, in order to allow such other Party to comment upon such announcement or disclosure. Each Party agrees that it shall cooperate fully and in a timely manner with the other with respect to all disclosures regarding this Agreement to the Securities Exchange Commission and any other governmental or regulatory agencies, including requests for confidential treatment of proprietary information of either Party included in any such disclosure. Notwithstanding any other provision of this Agreement, each Party may disclose the terms of this Agreement to lenders, investment bankers and other financial institutions ("Third Party Lender") of its choice solely for purposes of financing the business operations of such Party either (i) upon the written consent of the other Party or (ii) if the disclosing Party obtains a signed confidentiality agreement with such financial institution with respect to such information, such agreement to contain, at a minimum, the following: (i) The Third Party Lender shall hold the information disclosed to it by such Party ("Loan Information") in strict confidence and shall use diligent efforts, which shall not in any event be less than the Third Party Lender uses to prevent unauthorized use or disclosure of its own valuable, confidential information, to prevent any unauthorized use or disclosure of such Loan Information. (ii) The Third Party Lender shall not, without the prior written consent of such Party, use the Loan Information disclosed to it for any purpose of other than the use for which such Loan Information was disclosed by such Party. (iii) Upon completion of the authorized use by such Third Party Lender and in the absence of any further agreement between the Parties, the Third Party Lender shall cease all use and make no further use of the Loan Information and shall, upon written request from such Party, promptly return all Loan Information to such Party. 17.5 PUBLICITY. Subject to Section 17.4, all publicity, press releases and other announcements relating to this Agreement or the transaction contemplated hereby shall be reviewed in advance by, and shall be subject to the approval of, both Parties. 17.6 PUBLICATION. 17.6.1 The Parties shall cooperate in appropriate publication of the results of research and development work performed pursuant to this Agreement, but subject to their predominating interest in obtaining patent protection for any patentable subject matter. The determination of authorship for any paper shall be in accordance with accepted scientific practice. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 108. 122 17.6.2 Notwithstanding anything in Section 17.6.1 to the contrary, all publication and presentations of the results of research and development work performed pursuant to this Agreement must be approved in advance by both Parties; provided, however, either Party may disclose such results to the extent required to comply with applicable laws, including without limitation the rules and regulations promulgated by the Securities and Exchange Commission and the Party intending to disclose the terms of this Agreement shall provide the nondisclosing Party an opportunity to review and comment on the intended disclosure in reasonably sufficient time (such time period to depend on the urgency of the intended disclosure) prior to public release, and shall provide the other Party with a written copy thereof, in order to allow such other Party to comment upon such announcement or disclosure. Each Party agrees that it shall cooperate fully with the other with respect to all disclosures regarding this Agreement to the Securities Exchange Commission and any other governmental or regulatory agencies, including requests for confidential treatment of proprietary information of either Party included in any such disclosure. The contribution of each Party shall be noted in all publications or presentations by acknowledgment or coauthorship, whichever is appropriate. 17.6.3 Nothing in this Agreement shall be construed as preventing or in any way inhibiting either Party from complying with statutory and regulatory requirements governing such Party's obligations under this Agreement regarding the DEVELOPMENT, MANUFACTURE DEVELOPMENT, use and sale or other distribution of PRODUCT in the FIELD in the TERRITORY in any manner which it reasonably deems appropriate, including, for example, by disclosing to regulatory authorities confidential or other information received from the other Party or THIRD PARTIES. 17.7 PRIOR CONFIDENTIALITY AGREEMENTS. This Agreement, and the obligation of confidentiality and nondisclosure under this Article 17, supersedes all prior understandings and agreements relating thereto, including without limitation, the Confidentiality Agreement between Coulter and SB dated April 13, 1995, as extended by letter agreement on May 7, 1997, the Confidentiality Agreement between Coulter and SB, dated January 21, 1998 and the Confidentiality Agreement between Coulter and SB, dated March 30, 1998 (collectively, the "Prior Confidentiality Agreements"). The Prior Confidentiality Agreements are null and void and have no further force or effect. ARTICLE 18 DISPUTE RESOLUTION 18.1 GENERAL. The Parties recognize that disputes as to certain matters may from time to time arise during the term of this Agreement which relate to either Party's rights or obligations hereunder. The Parties have provided in this Agreement for procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. The Parties shall seek to follow the informal dispute resolution mechanisms set forth in this Agreement prior to pursuing any administrative or judicial resolution mechanism. In the event no mutually acceptable resolution of such dispute is achieved in accordance with the informal dispute resolution mechanisms set forth in this [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 109. 123 Agreement within a reasonable period of time, then either Party shall be entitled to seek final settlement of such dispute by any administrative or judicial resolution mechanisms which may be available. 18.2 [*]. [*], either Party may request that a recommendation be obtained from [*] pursuant to the process set forth in Section 18.3. Such recommendation, if obtained, shall be [*] or [*]. In the event that neither Party desires to pursue the process set forth in Section 18.3, the last sentence of Section 18.1 shall be applicable. 18.3 RECOMMENDATION OF [*]. If requested by either Party [*], the Parties shall [*] within [*] of the request of the Party invoking this Section 18.3. Each Party shall have [*] after [*] to submit [*] as such Party believes necessary to resolve the dispute in question, [*]. [*] may then hold [*] on the issues that need to be resolved. [*] shall promptly thereafter make a recommendation as to the resolution of the dispute, which recommendation [*]. Each Party shall bear its own expenses in connection with a procedure under this Section 18.3, and the fees and expenses of [*] shall be borne equally by the Parties regardless of the ultimate recommendation of such person. The results of a procedure under this Section 18.3 shall be used by the Parties to [*]. 18.4 GOVERNING LAW; JURISDICTION; VENUE. This Agreement shall be interpreted in accordance with the laws of the State of Delaware, without regard to the conflict of laws provisions thereof. Any claim or controversy arising out of or related to this Agreement or any breach hereof which is brought by SB shall be submitted to a court of competent jurisdiction and venue in [*], and each Party hereby consents to the jurisdiction and venue of such courts for such claim or controversy; provided, however, disputes regarding the validity or enforceability of PATENT RIGHTS or TRADEMARKS shall be submitted to a court of applicable jurisdiction where the PATENT RIGHT or TRADEMARK was issued. Any claim or controversy arising out of or related to this Agreement or any breach hereof which is brought by Coulter shall be submitted to a court of competent jurisdiction and venue in [*], and each Party hereby consents to the jurisdiction and venue of such courts for such claim or controversy; provided, however, disputes regarding the validity or enforceability of PATENT RIGHTS or TRADEMARKS shall be submitted to a court of applicable jurisdiction where the PATENT RIGHT or TRADEMARK was issued. 18.5 ARBITRATION FOR REASONABLE ROYALTY DETERMINATION. 18.5.1 Notwithstanding the other provisions of Article 18 or this Agreement, in the event that Coulter loses its rights to CO-PROMOTE PRODUCT in TERRITORY A in accordance with Sections 4.2.3 or foregoes such rights in accordance with the third sentence of Section 7.1.15, and the Parties cannot agree to a commercially reasonable royalty rate within the time periods set forth in Section 7.1.15, such matters shall be resolved by binding arbitration in [*] in accordance with the then existent [*]. The payments to Coulter provided in Section 7.1.15 pending the resolution of such commercially reasonable royalty rate shall continue until such matter has been resolved by such arbitration. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 110. 124 18.5.2 The decision of the Arbitration Tribunal in any arbitration conducted pursuant to Section 18.5.1 shall be final and not appealable, and shall be enforceable in any court of competent jurisdiction. No punitive damages will be recoverable by either Party in such a proceeding. The Parties agree that the service of any notice in the course of such arbitration proceeding at their respective addresses as provided for in Section 19.6 below shall be valid and sufficient. The appointing authority shall be the American Arbitration Association. Unless agreed otherwise by the Parties, in any arbitration proceeding hereunder, there shall be one (1) arbitrator, appointed by the Parties by mutual agreement. The Parties agree that in the event of an arbitration under this Section 18.5, the arbitrator shall apply the provisions of Section 10 of the Commercial Arbitration Rules, Revised and Effective July 1, 1996, relating to the conduct of a preliminary hearing. The Parties agree further that at such preliminary hearing the arbitrator shall require that the Parties provide at least the following materials related to such arbitration: (i) the extent and schedule of the production of relevant documents and other information; (ii) a list of any witnesses to be called, along with a brief description of the each witness's knowledge; (iii) a list of any experts to be called, along with a statement of the experts' backgrounds and opinions; and (iv) a schedule for the delivery of any briefs to be filed with the arbitration panel. A Party shall not have the right to depose the other Party's witnesses or experts in preparation for such arbitration, except with such other Party's consent. The Parties shall jointly share the expenses of the arbitration, provided that each Party shall solely bear its own legal or other OUT-OF-POCKET COSTS related to such arbitration. 18.5.3 In the case of an arbitration under Section 18.5.1, (i) the decision of the arbitrators shall be limited to a determination of a commercially reasonable royalty rate in the event that Coulter loses its rights to CO-PROMOTE PRODUCT in TERRITORY A in accordance with Sections 4.2.3 or foregoes such rights in accordance with the third sentence of Section 7.1.15, (ii) the parameters of such determination shall be limited to sales of PRODUCT in TERRITORY A after the effective date of such loss or relinquishment of rights to CO-PROMOTE, and (iii) such determination shall be higher than the royalty rate to be paid by SB to Coulter on sales of PRODUCT in TERRITORY B but less than the amount Coulter would have received had it continued to CO-PROMOTE PRODUCT in TERRITORY A. Such determination shall be final and binding on the Parties. The commercially reasonable royalty rate to be paid by SB to Coulter, as determined by such arbitrator, shall be retroactively applied to the effective date of Coulter's loss or relinquishment of rights to CO-PROMOTE, subject to a reconciliation by the arbitrator of the payments made by SB to Coulter under Section 7.1.15 pending the resolution of such issue by such arbitrator. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 111. 125 ARTICLE 19 MISCELLANEOUS 19.1 CONDITIONS TO EFFECTIVENESS. The Parties agree that: 19.1.1 the Effective Date of this Agreement shall be that date upon which the conditions set forth in this Section 19.1 are satisfied, or waived by the Parties hereto; 19.1.2 the effectiveness of the Agreement is conditioned upon [*] the [*]: (i) [*], and (ii) [*] and [*]; 19.1.3 [*] as the Parties may mutually agree [*]. [*] if the [*] and [*] and [*]; 19.1.4 [*], SB may waive the conditions to effectiveness set forth under this Section 19.1 and the date of such waiver shall be the Effective Date; 19.1.5 in the event that (i) [*] or (ii) [*], this Agreement shall be null and void and of no further force and effect, and neither Party shall have any liability to the other arising from the execution of this Agreement; 19.1.6 [*]; and 19.1.7 [*], all DEVELOPMENT COSTS, MANUFACTURE DEVELOPMENT COSTS, and MARKETING COSTS incurred by either Party between October 1, 1998 and the Effective Date under the terms of this Agreement shall be subject to all of the terms and provisions of this Agreement related thereto, including provisions related to reimbursement and sharing of such costs. SB shall have no liability to reimburse or share any costs incurred by Coulter between October 1, 1998 and the Effective Date which are not DEVELOPMENT COSTS, MANUFACTURE DEVELOPMENT COSTS, and MARKETING COSTS. 19.2 NO WAIVER OF CONTRACTUAL RIGHTS. The failure of either Party to require performance by the other Party of any of that other Party's obligations hereunder shall in no manner affect the right of such Party to enforce the same at a later time. No waiver by any Party hereto of any condition, or of the breach of any provision, term, representation or warranty contained in 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 condition or breach, or of any other condition or of the breach of any other provision, term representation or warranty hereof. 19.3 EXECUTION AND AMENDMENTS. 19.3.1 Each Party shall execute and deliver all such instruments and perform all such other acts as the other Party may reasonably request in order to carry out the transactions contemplated by this Agreement. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 112. 126 19.3.2 This Agreement may not be amended or modified except by written instrument signed by or on behalf of both Parties. 19.4 SEVERABILITY. If a court or other tribunal of competent jurisdiction should hold any term or provision of this agreement to be excessive, or invalid, void or unenforceable, the offending term or provision shall be deemed inoperative to the extent that they may conflict therewith and shall be deemed to be modified to the extent necessary to conform with such statute or rule of law, while still preserving, to the extent practicable, the legitimate aims of the Parties, provided that the remaining portions hereof shall remain in full force and effect. In the event that the terms and conditions of this Agreement are materially altered as a result of the above, the Parties will renegotiate the terms and conditions of this Agreement to resolve any inequities. 19.5 RELATIONSHIP BETWEEN THE PARTIES. Both Parties are independent contractors under this Agreement. Nothing contained in this Agreement is intended nor shall be construed so as to constitute Coulter or SB as partners or joint venturers with respect to this Agreement. Neither Party shall have the express or the implied right nor authority to assume or create any obligations on behalf of or in the name of the other Party, nor to bind the other Party to any other contract, agreement or undertaking with any THIRD PARTY. 19.6 CORRESPONDENCE AND NOTICES. 19.6.1 Correspondence, reports, documentation, and any other communication in writing between the Parties in the course of ordinary implementation of this Agreement (but not including any notice required by this Agreement) shall be in writing and delivered by hand, sent by facsimile, or by overnight express mail (e.g., FedEx) to any one (1) member of the JCC or JDC, as appropriate, appointed by the Party which is to receive such written communication, or any other way as the JCC or JDC deems appropriate. 19.6.2 Extraordinary notices and communications (including but not limited to notices of termination, force majeure, material breach, change of address, or any other notices required by this Agreement) shall be in writing and sent by prepaid registered or certified air mail or by overnight express mail (e.g., FedEx), or by facsimile confirmed by prepaid registered or certified air mail letter or by overnight express mail (e.g., FedEx), and shall be deemed to have been properly served to the addressee upon receipt of such written communication. 19.6.3 In the case of Coulter, the proper address for communications and for all payments shall be: Coulter Pharmaceutical, Inc. 550 California Avenue, Suite 200 Palo Alto, California 94306 USA Facsimile: (650) 849-7574 Attn: Chief Financial Officer [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 113. 127 With copies to: Coulter Pharmaceutical, Inc. 550 California Avenue, Suite 200 Palo Alto, California 94306 USA Facsimile: (650) 849-7574 Attn: Chief Executive Officer and Coulter Pharmaceutical, Inc. 550 California Avenue, Suite 200 Palo Alto, California 94306 USA Facsimile: (650) 849-7574 Attn: Vice President, Business Development and in the case of SB, the proper address for communications and for all payments shall be: SmithKline Beecham Corporation One Franklin Plaza (Mail Code FP1930) P.O. Box 7929 Philadelphia, Pennsylvania 19101 U.S.A. Attention: Senior Vice President, Business Development With copies to: SmithKline Beecham Corporation One Franklin Plaza (Mail Code FP2360) P.O. Box 7929 Philadelphia, Pennsylvania 19101, U.S.A. Attention: Corporate Law-U.S. 19.7 COUNTERPARTS. This Agreement may be executed in one or more counterparts, each of which shall be an original and all of which shall constitute together the same document. 19.8 WAIVER OF BREACH. Any delay in enforcing a Party's rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of a Party's right to the future enforcement of its rights under this Agreement, excepting only as to an expressed written and signed waiver as to a particular matter for a particular period of time. All rights, remedies, undertakings, obligations and agreements contained in this Agreement shall be cumulative and except as otherwise expressly provided herein none of them shall be a limitation of any other remedy, right, undertaking, obligation or agreement. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 114. 128 19.9 NO INTELLECTUAL PROPERTY RIGHTS GRANTED. No rights or licenses with respect to a Party's patents, trademarks, know-how, technical information, or other proprietary rights are granted or deemed granted to the other Party hereunder or in connection herewith, other than those rights expressly granted in this Agreement. 19.10 RECORDING. Either Party shall have the right, at any time, to record, register, or otherwise notify this Agreement in appropriate governmental or regulatory offices anywhere in the TERRITORY, and the other Party shall provide reasonable assistance to such Party in effecting such recording, registering or notifying. 19.11 HEADINGS; INTERPRETATION. Headings in this Agreement are included for ease of reference only and shall have no legal effect. This Agreement shall be deemed to comprise the language mutually chosen by the Parties and no rule of strict construction shall be applied against either Party. In this Agreement, the singular shall include the plural and vice versa and the word "including" shall be deemed to be followed by the phrase "without limitation" unless otherwise specified. 19.12 EXPENSES. Except as otherwise provided in this Agreement, all expenses incurred by SB in connection with its obligations under this Agreement will be borne solely by SB and all expenses incurred by Coulter in connection with its obligations under this Agreement will be borne solely by Coulter. Each Party will be responsible for appointing its own employees, agents and representatives, who will be compensated by such Party. Each Party will be responsible for paying any finder's or broker's fee owed to a THIRD PARTY that such Party incurs based directly or indirectly on negotiating and entering this Agreement, and shall indemnify the other Party against any obligation to pay such fee. 19.13 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. 19.14 OFFICIAL LANGUAGE. The official text of this Agreement and any appendices, exhibits and schedules hereto, shall be made, written and interpreted in English. Any notices, accounts, reports, documents, disclosures of information or statements required by or made under this Agreement, whether during its term or upon expiration or termination thereof, shall be in English. In the event of any dispute concerning the construction or meaning of this Agreement, reference shall be made only to this Agreement as written in English and not to any other translation into any other language. 19.15 ENTIRE AGREEMENT; TAX AGREEMENT. This Agreement, together with its Exhibits, the STOCK PURCHASE AGREEMENT, and the LOAN AGREEMENT, constitutes the entire agreement of the Parties with respect to the subject matter hereof as of the date of its execution, and supersedes all prior agreements, understandings, representations and proposals, written or oral, relating thereto. In addition, upon the request of either Party, the Parties will discuss whether they desire to enter into an agreement regarding the tax treatment of their activities under this Agreement. If the Parties mutually agree that such an agreement is necessary or desirable, they will each bear their own expenses incurred in connection with the preparation of such an agreement, and [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 115. 129 (unless the Parties otherwise agree in the future), any mutually agreed OUT-OF-POCKET COSTS incurred in connection with the development of tax information pursuant to such an agreement shall be shared equally. If only one Party believes that such an agreement is necessary or desirable, that Party shall bear the costs of preparing such an agreement, and shall bear the OUT-OF-POCKET COSTS of developing tax information pursuant to such an agreement. In any event, each Party shall bear its own internal expenses in connection with the negotiation and preparation of any such tax agreement and the preparation of its own tax returns. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 116. 130 IN WITNESS WHEREOF, the Parties, through their authorized officers, have executed this Agreement on the date first written above, to become effective on the Effective Date. SMITHKLINE BEECHAM CORPORATION COULTER PHARMACEUTICAL, INC. BY: /s/ Jean-Pierre Garnier BY: /s/ Michael F. Bigham ----------------------------- ----------------------------- TITLE: Chief Operating Officer TITLE: President and CEO -------------------------- --------------------------- 131 EXHIBITS: EXHIBIT A COULTER PATENT RIGHTS EXHIBIT B-1 FINANCIAL PLANNING, ACCOUNTING AND REPORTING METHODOLOGIES EXHIBIT B-2 FTE RATES EXHIBIT C COUNTRIES IN EUROPE EXHIBIT D PLANNED CLINICAL TRIALS EXHIBIT E SB PATENT RIGHTS EXHIBIT F-1 SB/COULTER BEXXAR PRODUCT TEAM EXHIBIT F-2 SALES EXPERTISE AND ACTIVITIES TO BE CONTRIBUTED BY EACH PARTY EXHIBIT G SB FORM OF MARKETING PLAN EXHIBIT H PHARMACOVIGILANCE RESPONSIBILITIES OF COULTER AND SB EXHIBIT I PRODUCT-RELATED INQUIRIES EXHIBIT J PRODUCT RECALL PROCEDURES 132 EXHIBIT A COULTER PATENT RIGHTS
- ----------------------------------------------------------------------------------------- [ATTORNEY [SERIAL NO. / [FILED/ DOCKET NO.] PATENT NO.] ISSUED] [TITLE] - ----------------------------------------------------------------------------------------- [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] - -----------------------------------------------------------------------------------------
* Claims priority/effective filing date of earlier application ** ABANDONED in favor of [*] [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 133 EXHIBIT B-1 FINANCIAL PLANNING, ACCOUNTING AND REPORTING METHODOLOGIES (OPERATING PROFIT OR LOSS) This EXHIBIT B-1 addresses the financial planning, accounting policies and procedures to be followed under the Agreement in determining sharing of revenue and expenses and related sharing of OPERATING PROFIT OR LOSS in TERRITORY A. Terms not defined in this EXHIBIT B-1 shall have the meanings set forth in the Agreement. This Exhibit sets forth the principles for reporting actual results and budgeted plans of each Party in TERRITORY A for PRODUCT, the frequency of reporting, [*], the methods of determining payments to the Parties, and auditing of accounts. OPERATING PROFIT AND LOSS will be shared by the Parties in accordance with Section 7.1.13 of the Agreement. Pursuant to Section 7.1.14, only those costs incurred subsequent to the Effective Date will be included in the calculation of OPERATING PROFIT AND LOSS. Each Party's OUT-OF-POCKET COSTS that are SALES COSTS, MARKETING COSTS and other related expenses incurred prior to commercial launch of PRODUCT will be shared according to Section 7.1.12(a) of the Agreement. B.1. PRINCIPLES OF REPORTING In accordance with Section 7.1.14 of the Agreement, the result of operations of each Party with respect to PRODUCT in TERRITORY A will be presented in the following format, with the categories as defined in Section B.3 below: [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] Overhead and FTE allocations are excluded from the calculation of OPERATING PROFIT AND LOSS except as expressly provided in this Exhibit or the Agreement. It is the intention of the Parties that the interpretation of these definitions will be consistent with generally accepted accounting principles in the United States ("GAAP"). [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 134 B.2. FREQUENCY OF REPORTING For purposes of the requirements herein, the fiscal year will be [*]. Reporting shall occur in accordance with Section 7.1.14. B.3. DEFINITIONS B.3.1 "COST OF GOODS" shall have the meaning set forth in Section 1.11 of the Agreement, subject to Section 7.1.14. B.3.2 "DISTRIBUTION COSTS" means the OUT-OF-POCKET COSTS specifically identifiable to the distribution of a PRODUCT including [*]. B.3.3 "MARKETING COSTS" means, consistent with the JOINT MARKETING PLAN, the OUT-OF-POCKET COSTS of marketing, promotion, advertising, [*], PRODUCT-related public relations, [*], market research, [*], customer services, [*], and other similar activities directly related to the PRODUCT. Such costs will include outside services and expenses [*]. MARKETING COSTS shall also include (a) activities related to obtaining reimbursement from payers and costs of sales and marketing data and (b) cost of samples. MARKETING COSTS will specifically exclude (i) the costs of activities which promote either Party's business as a whole without being product specific [*] (ii) [*] and (iii) any FTEs associated with supporting the activities included in the definition of MARKETING COSTS. B.3.4 "NET SALES" shall have the meaning set forth in Section 1.54 of the Agreement. B.3.5 "OPERATING PROFIT OR LOSS" means the consolidated NET SALES for PRODUCT in TERRITORY A less Coulter Operating Expenses and SB Operating Expenses (each as defined in Section 7.1.14) for a given period. B.3.6 "OTHER OPERATING INCOME/EXPENSE" means other operating income or expense from or to THIRD PARTIES which is not part of the primary business activity of the applicable Party, but is related to income or expense generated from such Party's operations specifically attributable to its activities under this Agreement, and, unless otherwise mutually agreed by the Parties, limited to the following: _ [*] _ [*] _ [*] B.3.7 "PATENT COSTS" shall have the meaning set forth in Section 1.65 of the Agreement. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 2. 135 B.3.8 "SALES COSTS" means costs incurred consistent with the JOINT MARKETING PLAN and the annual budget prepared pursuant to such JOINT MARKETING PLAN and specifically identifiable to the SALES EFFORT (as defined in Section 7.1.6(a) of the Agreement) in TERRITORY A including the managed care market. SALES COSTS shall be charged on an FTE basis at the rate specified in EXHIBIT B-2. The FTE rate shall include [*]. B.3.9 "TRADEMARK COSTS" shall have the meaning set forth in Section 1.95 of the Agreement. B.4. AUDITS Either Party shall have the right to conduct audits of the other Party's books pursuant to Section 8.3 of the Agreement. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 3. 136 EXHIBIT B-2 ANNUAL FTE RATES Coulter FTE Rate for Sales Effort Personnel: $[*] Coulter FTE Rate for All Other Personnel: $[*] SB FTE Rate for Sales Effort Personnel: $[*] SB FTE Rate for All Other Personnel: $[*] [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 137 EXHIBIT C COUNTRIES IN EUROPE ANDORRA AUSTRIA BELGIUM BOSNIA BULGARIA CROATIA CYPRUS CZECH REPUBLIC DENMARK ESTONIA FINLAND FRANCE GERMANY GREECE HUNGARY ICELAND IRELAND ISRAEL ITALY LATVIA LIECHTENSTEIN LITHUANIA LUXEMBOURG MONACO NETHERLANDS NORWAY POLAND PORTUGAL ROMANIA RUSSIA SAN MARINO SERBIA SLOVAKIA SLOVENIA SPAIN SWEDEN SWITZERLAND UNITED KINGDOM VATICAN CITY YUGOSLAVIA
138 EXHIBIT D PLANNED CLINICAL TRIALS
TRIAL NUMBER TRIAL NAME ------------ ---------- [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 139 [*] [*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 2. 140 EXHIBIT E SB PATENT RIGHTS [*] [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 141 EXHIBIT F-1 SB/COULTER BEXXAR PRODUCT TEAM [*] [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 1. 142 EXHIBIT F-2 SALES EXPERTISE AND ACTIVITIES TO BE CONTRIBUTED BY EACH PARTY
- -------------------------------------------------------------------------------- COULTER SB - -------------------------------------------------------------------------------- [*] [*] [*] [*] o [*] o [*] o [*] o [*] o [*] o [*] o [*] [*] o [*] o [*] [*] o [*] o [*] o [*] o [*] [*] [*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 1. 143 EXHIBIT G [*] [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 1. 144 EXHIBIT H PHARMACOVIGILANCE RESPONSIBILITIES OF COULTER AND SB BACKGROUND: As described in the Agreement, Coulter retains primary registration responsibilities in the United States (US), while SB retains primary registration responsibilities outside of the US. Obligations for reporting adverse events/reactions to regulatory health authorities for clinical trial experiences and postmarketing experiences will follow the same divisions of responsibilities. Coulter and SB want to share relevant safety information, within certain time frames, in order to comply with applicable regulatory reporting requirements. DEFINITIONS: The following definitions reflect and are consistent with FDA and ICH regulations/guidelines. o ADVERSE EXPERIENCE (AE) The ICH has defined an AE as "Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment." o ADVERSE DRUG REACTION (ADR) In the PRE-APPROVAL clinical experience or in other clinical trial experiences The ICH has defined an ADR in clinical trials as "all noxious and unintended responses to a medicinal product related to any dose." The phrase "responses to a medicinal product" means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. For MARKETED medical products The ICH had defined an ADR in marketed medicinal products as "a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for modification of physiological function." o UNEXPECTED ADR The ICH has defined an unexpected ADR as "an adverse drug reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator Brochure for an unapproved investigational medicinal product." [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 145 This definition includes an AE/ADR of which the nature, specificity, or severity is inconsistent with the applicable PRODUCT information. For an AE/ADR from a clinical trial, the reference document shall be the Investigator Brochure. For an AE/ADR from a spontaneous report or other postmarketing source, the reference documents shall be the core PRODUCT information (PI) or local PI. o CRITERIA FOR SERIOUS AE OR ADR A serious AE or ADR is any untoward medical occurrence that: o results in death, o is life-threatening (NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), o requires inpatient hospitalization or a prolongation of existing hospitalization, o results in persistent or significant disability/incapacity, or o is a congenital anomaly/birth defect. Medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. These should also usually be considered serious. (Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; or development of drug dependency or drug abuse.) o NON-SERIOUS AE A non-serious AE is any experience which does not meet the definition of serious as defined above. Clinical trial experiences which are not considered "serious" include: hospitalization for a pre-planned/elective procedure for a medical condition present before treatment started; a pre-existing medical condition which does not increase in severity or frequency following treatment; or an experience which is simply a treatment failure according to the efficacy criteria for the study. o SPONTANEOUS REPORTS Reports from any source other than a clinical trial source, including regulatory agencies, health care professionals, consumers and literature, shall be classified for reporting purposes as a spontaneous report. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 3. 146 o REPORTS OF PREGNANCY AND OVERDOSE While such reports are not AEs or ADRs as defined herein, reports of pregnancies should be followed up until the outcome of the pregnancy is known. PRODUCT has been clinically tested to define the maximally tolerated dose. "Overdose" will be defined as when the administered dose is >10% of the prescribed dose or any dose that the reporter of an ADR indicates as being an overdose for the patient receiving such dose. o MINIMAL CRITERIA FOR REPORTING Initial reports should be submitted within the prescribed timelines as long as the following minimum criteria are met: (1) an identifiable patient; (2) a suspect medicinal product; (3) an identifiable reporting source; (4) and an event or outcome. FOLLOW-UP OF CASES: The Party who is the initial recipient of an AE/ADR report shall be responsible for appropriate follow-up of that AE/ADR report and timely transmission of relevant new information to the other Party. SAFETY DATABASE: Coulter will hold the recognized worldwide safety database for BEXXAR. Coulter shall have full access to SB's worldwide safety database to enter, edit, analyze, and print AE/ADR reports for BEXXAR until such time that the JDC has determined that (a) Coulter has established a fully validated safety database that meets worldwide pharmacovigilance regulatory requirements and (b) a secure electronic data exchange has been established between the Parties for the electronic exchange of safety information. The Parties shall agree upon a process to track any edits or amendments Coulter makes to the SB worldwide safety database. Coulter will hold the recognized worldwide safety database for PRODUCT other than BEXXAR ("Additional Product"), except that SB shall hold the recognized safety database for any Additional Product incorporating SECOND GENERATION LICENSED COMPOUNDS that arise from SB's research. DATA EXCHANGE: o SB will notify Coulter electronically (or by facsimile if electronic means is not available) of all serious AE reports (including both clinical trial and spontaneous AEs) that SB receives within two (2) calendar days of receipt of such reports by the SB Central Safety Department in the United Kingdom. When the minimum information required for reporting can not be transmitted due to translation difficulties, SB shall notify Coulter within three (3) working days of initial receipt of such reports. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 4. 147 o SB will notify Coulter by facsimile of any fatal or life-threatening ADRs within twenty four (24) hours of receipt. o Non-serious spontaneous AE reports received by SB will be submitted to Coulter within five (5) working days of receipt of such reports by the SB Central Safety Department. o Coulter will provide SB with CIOMS I forms electronically (or by facsimile if electronic means is not available) for all U.S. serious AEs within two (2) calendar days of receipt. o Coulter will notify SB by facsimile of any fatal or life-threatening ADRs within twenty four (24) hours of receipt by Coulter. o Coulter is responsible for receiving and forwarding reports to and from other Coulter licensees (if applicable). o SB is responsible for receiving and forwarding reports to and from other SB sublicensees (if applicable). LITERATURE REPORTS: Each Party shall be responsible for scanning the literature for case reports in any territory in which it holds registration rights as set forth in this agreement. REGULATORY REPORTING: o Reporting of domestic or foreign cases to the local regulatory authorities is the responsibility of the local registration holder. o SB shall be responsible for reporting of domestic cases to the local regulatory authorities in those countries where SB is the local registration holder. o Coulter shall be responsible for reporting domestic cases to the FDA in the United States. o Coulter will be responsible for reporting IND safety reports to the FDA. o Reporting to other regulatory authorities will be the responsibility of the local registration holder. INVESTIGATOR NOTIFICATION: o Notification of submitted alert reports to investigators and to the local regulatory authorities is the responsibility of the local registration holder. o Coulter shall be responsible for preparing the notifications and providing a copy to SB for review. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 5. 148 o Coulter shall be responsible for notification of investigators in the U.S. and notification of the FDA. o SB shall be responsible for notification of investigators and the local regulatory authorities in those countries where SB is the local registration holder. PERIODIC PRODUCT SAFETY UPDATE REPORT (PSUR): The International birth date is the date of first regulatory approval in the world. This date will determine the anniversary dates for Product Safety Update Reports (PSURs). Coulter will produce AE/ADR listings on a semiannual basis beginning with the International birth date of PRODUCT with consecutive six-monthly data lock points from that date onward. On each data lock point date, each Party will provide the other Party with the most up-to-date available sales or usage figures from their respective TERRITORIES. Each Party will further supply the other Party with copies of the safety sections of any "end of study" reports associated with PRODUCT for trials conducted by that Party. Analysis of the clinical safety information contained in the PSUR will be done jointly by the Safety Departments of both Parties. Coulter is responsible for forwarding the PSURs to other Coulter licensees (as applicable) to enable them to meet their local regulatory reporting obligations. SB is responsible for forwarding the PSURs to other SB sublicensees (as applicable) to enable them to meet their local regulatory reporting obligations. Coulter will be responsible for producing the U.S. Periodic AE Report, with data provided by SB as required, until such time as the FDA accepts PSURs. CORE PRODUCT INFORMATION CHANGES: Safety changes to the core PRODUCT information (PI) or local PI will be made in consultation between SB and Coulter. Each Party will then simultaneously amend their respective package inserts (core and local). Coulter will be responsible for communicating such changes to the other Coulter licensees, as applicable. SB will be responsible for communicating such changes to other SB sublicensees, as applicable. The JOINT DEVELOPMENT COMMITTEE will decide the forum in which these changes are to be decided. RESPONDING TO SAFETY RELATED OR PRODUCT-RELATED REGULATORY INQUIRIES: Each Party will keep the other Party informed of any safety-related or PRODUCT-related regulatory inquiries and cooperate in providing requested information promptly. TRAINING OF SALES REPRESENTATIVES: o The Parties will collaborate in the generation of materials for training the sales force on safety monitoring and reporting responsibilities. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 6. 149 o SB will provide generic training materials to Coulter and Coulter will provide Product-specific materials to SB. METHOD FOR REVISING THIS PHARMACOVIGILANCE EXHIBIT: If either Party desires to revise this Pharmacovigilance Exhibit due to changes in definitions, regulations, or for any other reason, such Party shall contact the other Party and the pharmacovigilance Exhibit shall be revised following written agreement by both Parties. PHARMACOVIGILANCE CONTACTS IN EACH PARTY:
FOR SB: CONTACT ADDRESS AND NUMBERS - ------------------------------------------------------------------------------------- Primary: [*] SmithKline Beecham Corporation Associate Director New Frontiers Science Park (South) Worldwide Clinical Safety Third Avenue, The Pinnacles SmithKline Beecham Corporation Harlow, Essex CM19 5AG E-mail: Tel: [*] [*]@sbphrd.com Fax: [*] US Contact: [*] SmithKline Beecham Corporation Director, Safety Quality Mgmt. 1250 South Collegeville Road SmithKline Beecham Corporation Collegeville, PA 19426-0989 Tel: [*] E-mail: Fax: [*] [*]@sbphrd.com FOR COULTER: CONTACT ADDRESS AND NUMBERS - -------------------------------------------------------------------------------- Primary: [*] Coulter Pharmaceutical, Inc. Director, Medical Information and 550 California Avenue, Suite 200 Safety Palo Alto, CA 94306-1440 Coulter Pharmaceutical, Inc. Tel: [*] Fax: [*] E-mail: [*]@coulterpharm.com
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 7. 150 EXHIBIT I PRODUCT-RELATED INQUIRIES RESPONSIBILITIES OF COULTER AND SB BACKGROUND: As described in the Agreement, Coulter retains primary registration responsibilities in the United States (US), while SB retains primary registration responsibilities outside of the US. Obligations for answering medical or technical queries will follow the same divisions of responsibilities. Coulter and SB want to share relevant PRODUCT information in order to provide optimal education to individuals inquiring about the PRODUCT. RESPONDING TO PRODUCT-RELATED INQUIRIES: For PRODUCT-related inquires from customers who reside in the U.S. Coulter will answer all PRODUCT-related inquiries received from customers who reside in the US. SB shall forward all PRODUCT-related inquires received by it to Coulter within 1 business day, unless the urgent nature of the question necessitates a more rapid response. Members of the SB sales force will forward PRODUCT-related inquiries directly to Coulter for response. For PRODUCT-related inquires from customers who reside outside of the U.S. SB will answer all PRODUCT-related inquires received from customers who reside outside of the US. Coulter shall forward all PRODUCT-related inquires received by it from countries outside the U.S. to SB's Central Medical Affairs Team (CMAT) within 1 business day, unless the urgent nature of the question necessitates a more rapid response. DATABASE OF RESPONSES: Coulter will prepare and maintain a database containing responses to PRODUCT-related queries. The database, and any updates with new and/or updated responses to queries will be made available to SB as needed to support the commercialization of PRODUCT in countries outside of the US. SB may also prepare a database of responses to PRODUCT-related inquiries received from customers who reside outside of the U.S. Should SB develop such a database, it will make the contents and all updates (new or revised responses) available to Coulter. METHOD FOR REVISING THIS PRODUCT-RELATED INQUIRIES EXHIBIT: If either Party desires to revise this Product-Related Inquiries Exhibit for any reason, such Party shall contact the other Party and the Product-Related Inquiries Exhibit shall be revised following written agreement by both Parties. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 1. 151 PRODUCT-RELATED INQUIRY CONTACTS IN EACH PARTY:
FOR SB: CONTACT ADDRESS AND NUMBERS - ------------------------------------------------------------------------------------- Ex-US: [*] SmithKline Beecham Corporation [*] New Frontiers Science Park (South) [*] Third Avenue, The Pinnacles Harlow, Essex CM19 5AW Tel: [*] Fax: [*] E-mail: [*] US Contact: [*] SmithKline Beecham Corporation [*] FP 1010 [*] [*] 1 Franklin Plaza Philadelphia, PA 19101 E-mail: Tel: [*] [*]@sb.com Fax: [*] FOR COULTER: CONTACT ADDRESS AND NUMBERS - ------------------------------------------------------------------------------------ Primary: [*] Coulter Pharmaceutical, Inc. [*] 550 California Avenue [*] Suite 200 [*] Palo Alto, CA 94306-1440 Tel: [*] E-mail: Fax: [*]
[*] [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 2. 152 EXHIBIT J PRODUCT RECALL PROCEDURES Coulter shall handle all physical aspects relating to any PRODUCT recalls in TERRITORY A. SB shall handle all physical aspects relating to any PRODUCT recalls in TERRITORY B and TERRITORY C. At Coulter's request, SB will assist Coulter in obtaining and receiving any samples of PRODUCT or PRODUCT-related items that have been recalled in TERRITORY A. Any PRODUCT or PRODUCT-related items returned to SB in TERRITORY A shall be shipped by SB to Coulter's facility identified by Coulter as the point for receiving returned goods. SB and Coulter shall [*] in the direct documented costs incurred by each of them in TERRITORY A, TERRITORY B and TERRITORY C with respect to participating in any withdrawal or recall, including without limitation PRODUCT destruction, except that: Coulter shall [*] incurred in connection with such withdrawal or recall and [*], in cases where such withdrawal or recall was caused by Coulter by either of the following circumstances: (a) a defect in manufacturing (i.e. manufacturing not in accordance with Specifications and procedures approved by the FDA or other relevant government/regulatory agencies), including any adulteration, mislabeling or misbranding of PRODUCT if Coulter was responsible for that stage of manufacturing, or a PRODUCT or intermediate thereof failing to meet applicable regulatory specifications (e.g., the regulations of the FDA and European Commission Directive 91/356/EEC) or which will not meet applicable regulatory specifications at the end of shelf life, or (b) any misrepresentation or willful omission committed by Coulter, its employees, officers, directors, agents, representatives or AFFILIATES in connection with PRODUCT safety or efficacy data or information submitted or omitted from submission to any regulatory agency. (c) any misrepresentation made by Coulter or its employees, officers, directors, agents, representatives or AFFILIATES in connection with the promotion of PRODUCT, or (d) any other negligence or wrongful act committed by Coulter or its employees, officers, directors, agents, representatives or AFFILIATES in the distribution of PRODUCT including, but not limited to, improper storage and/or handling of PRODUCT. SB shall [*] incurred in connection with such withdrawal or recall and [*], in cases where such withdrawal or recall was caused by SB by either of the following circumstances: (a) a defect in manufacturing (i.e. manufacturing not in accordance with Specifications and procedures approved by the FDA or other relevant government/regulatory agencies), including any adulteration, mislabeling or misbranding of PRODUCT if SB was responsible for that stage of manufacturing, or a PRODUCT or intermediate thereof failing to meet [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 1. 153 applicable regulatory specifications (e.g., the regulations of the FDA and European Commission Directive 91/356/EEC) or which will not meet applicable regulatory specifications at the end of shelf life; (b) any misrepresentation or willful omission committed by SB, its employees, officers, directors, agents, representatives or AFFILIATES in connection with PRODUCT safety or efficacy data or information submitted or omitted from submission to any regulatory agency; (c) any misrepresentation made by SB or its employees, officers, directors, agents, representatives or AFFILIATES in connection with the promotion of PRODUCT; or (d) any other negligence or wrongful act committed by SB or its employees, officers, directors, agents, representatives or AFFILIATES in the distribution of PRODUCT including, but not limited to, improper storage and/or handling of PRODUCT. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 2.
EX-10.26 7 SUPPLY AGREEMENT W/BOEHRINGER INGELHEIM PHARMA KG 1 Exhibit 10.26 ***Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. Section 200.80(b)(4), 200.83 and 240.24b-2 CSUP15f.doc November, 3rd, 1998 SUPPLY - AGREEMENT This Agreement is made on November 3, 1998 (the "Effective Date"), by and between COULTER PHARMACEUTICAL INC., whose registered office is at 550 California Avenue, Palo Alto, California 94306-1440, U.S.A. (hereinafter referred to as "COULTER") and BOEHRINGER INGELHEIM PHARMA KG whose registered office is at Birkendorferstrasse 65, 88397 Biberach an der Riss, Federal Republic of Germany (hereinafter referred to as "BI PHARMA KG"). WITNESSETH WHEREAS the parties have previously entered into the Contract Research and Development Agreement (as such term is defined below) regarding the research and development of a method to produce ANTI B1 in a commercial scale; and WHEREAS BI PHARMA KG has developed and is the owner of the Process, and WHEREAS COULTER has all rights to the Product, and WHEREAS COULTER wishes BI PHARMA KG, and BI PHARMA KG agrees, to manufacture and supply COULTER with Product for commercial use, manufactured in accordance with the Process. NOW THEREFORE, the parties hereto agree as follows: 1. DEFINITIONS In this Agreement the following terms shall have the meanings indicated: 1.1 "ANTI B1" means the murine antibody directed against B-cells expressing the B-lymphoma phenotype. 1.2 "BI PHARMA KG Confidential Information" means all technical and other information relating to the Process and to BI PHARMA KG's facilities and associated technologies, excluding the COULTER Confidential Information, that is disclosed or supplied to, or used 1. 2 on behalf of, COULTER by BI PHARMA KG pursuant to this Agreement or the Contract Research and Development Agreement, whether patented or unpatented, including without limitation, trade secrets, know-how, processes, concepts, experimental methods and results, business and scientific plans. 1.3 "BLA" means a Biologics License Application, as defined by the regulations promulgated under the FD&C Act and the PHS Act and any supplements thereunder, as amended from time to time. 1.4 "Bulk Product" means ANTI B1 which has been purified to a concentrated form and can be stored in a liquid or frozen form under appropriate conditions in accordance with the Specifications. 1.5 "Capacity" means BI PHARMA KG'S total production capacity per year based on the basic production assumptions (see APPENDIX 1) of [...***...] per run, reserved for manufacture of Bulk Product, Final Product and Finished Product in accordance with the Process. Capacity shall be sufficient to produce a maximum of [...***...] of Bulk Product per calendar year, unless otherwise jointly agreed upon by the parties. The Capacity shall be subject to an increase to [...***...] according to BI PHARMA's option as laid down in Article 3.1.4 below. 1.6 "Cell Line" means the novel and proprietary cell line [...***...] developed by COULTER and provided to BI PHARMA KG pursuant to the terms of the Contract Research and Development Agreement. 1.7 "Certificate of Analysis" shall mean a document describing testing methods and results, the accuracy of which has been certified by the issuing party. 1.8 "Certificate of Compliance" shall mean a document (a) listing the expiration date and quantity of a particular batch of Bulk Product, Final Product and/or Finished Product, (b) certifying that such batch was manufactured in accordance with all Specifications, GMP, the BLA/EMEA dossier for the Product (as applicable), and (c) certifying that such batch is acceptable for manufacturer release. The agreed upon format is attached hereto as APPENDIX 6. 1.9 "Compliance Policy of BI PHARMA KG for Biopharmaceutical Contract Manufacturing for the U.S." means BI PHARMA KG's guidelines and procedures for Product quality and Product release as set forth in APPENDIX 7. 1.10 "Contract Research and Development Agreement" means the agreement between COULTER and Dr. Karl Thomae GmbH dated October 22, 1997 regarding the development of the Process, which agreement was assigned to Bl Pharma KG as of 01.01.1998. 1.11 "COULTER Confidential Information" means the Cell Line, Product and all technical and other information relating thereto, excluding BI PHARMA KG's Confidential Information, that is disclosed or supplied to BI PHARMA KG by COULTER pursuant to this Agreement or the Contract Research and Development Agreement, whether patented or unpatented, including, without limitation, trade secrets, know-how, processes, concepts, experimental methods and results, business and scientific plans. 1.12 "FDA" means the United States Food and Drug Administration and any successor thereto. *CONFIDENTIAL TREATMENT REQUESTED 2. 3 1.13 "FD&C Act" means the United States Federal Food, Drug and Cosmetic Act, as amended. 1.14 "Final Product" means Bulk Product that has been processed, compounded and formulated and placed in unlabeled final containers. 1.15 "Finished Product" means Final Product that has been labeled with commercial labels affixed to the final containers and packaged under appropriate conditions and is ready for shipment to COULTER or its designees. 1.16 "GMP" means the current regulatory requirements for good manufacturing practices promulgated by the FDA under the FD&C Act, 21 C. F. R. et seq and 21 C. F. R. Section 600-610, as applicable. 1.17 "Manufacturing Project Manager" shall have the meaning as specified in Article 2.1 hereof. 1.18 "Manufacturing Project Team" shall have the meaning as specified in Article 2.2 hereof. 1.19 "Process" means BI PHARMA KG's generic process for manufacturing Bulk Product, Final Product and Finished Product, which has been adapted to Product-requirements and agreed by the parties before producing Product under this Agreement. 1.20 "Process [...***...] Agreement" means that agreement as further described in Article 4.4 hereof. 1.21 "Product" means any product containing non-radiolabeled ANTI B1 as its sole or combined active ingredient and produced according to the Process whether as Bulk Product, Final Product or Finished Product. 1.22 "Product Price" means BI PHARMA KG's prices for Bulk Product, Final Product and/or Finished Product (as the case may be) to be calculated on the basis of the basic production assumptions set forth in APPENDIX 1. 1.23 "Project" means the activities performed under this Agreement. 1.24 "Specifications" means the specifications for Bulk Product, Final Product and Finished Product as applicable and the respective test methods attached hereto as APPENDIX 3 on the basis of the specifications provided by COULTER. Such Specifications may be amended from time to time by mutual agreement of COULTER and BI PHARMA KG according to further development of the Process and Product (e.g. according to the results of the Process [...***...] Agreement). The Specifications may vary from country to country as agreed upon by the parties. 2. COOPERATION BETWEEN THE PARTIES / PROJECT TEAM 2.1 DESIGNATION OF MANUFACTURING PROJECT MANAGER Promptly after the Effective Date, BI PHARMA KG and COULTER shall each identify a Manufacturing Project Manager who will be responsible exclusively for communicating all instructions and information concerning the Project to the other party. *CONFIDENTIAL TREATMENT REQUESTED 3. 4 Each Manufacturing Project Manager will be available on an agreed upon [...***...] basis for consultation (e.g. face to face meetings, telephone-conference, videoconference) at [...***...] times during the course of the Project. In the absence of the Manufacturing Project Manager of a party, a substitute shall be appointed by such party in due time. Additional modes or methods of communication and decision making may be implemented with the mutual consent of each party. 2.2 MANUFACTURING PROJECT TEAM Promptly after the Effective Date, BI PHARMA KG and COULTER shall each name representatives to a Manufacturing Project Team which shall consist of knowledgeable specialists in appropriate disciplines who shall be responsible for overseeing all activities of the parties under this Agreement. During the term of this Agreement, the Manufacturing Project Team shall meet [...***...] in a face to face meeting, for the purpose of communicating updates and providing a forum for decision making and rapid resolution of issues arising under this Agreement. Additional meetings (if required) of the Manufacturing Project Team may be conducted by telephone-conference, videoconference and/or face to face meetings. Meeting minutes shall be prepared jointly by the Manufacturing Project Team to record all issues discussed and decisions made. The present list of the members of the Manufacturing Project Team is attached hereto as APPENDIX 4. The members of the Manufacturing Project Team may be changed from time to time as appropriate. 2.3 COOPERATION. In the course of the Project, BI PHARMA KG will at all times take into consideration and implement the recommendations of COULTER as long as they do not adversely affect BI PHARMA KG's ability to perform other BI PHARMA KG biotech operations and are agreed upon by the Manufacturing Project Team. In the absence of explicit instructions from COULTER, BI PHARMA KG shall be entitled to employ its reasonable judgment in carrying out the Project consistent with BI PHARMA KG's overall obligations under this Agreement and consistent with the BLA and the EMEA application. 2.4 FDA OR OTHER AUTHORITIES INTERACTION. BI PHARMA KG has the express right to send representatives to any meeting of or on behalf of COULTER with the FDA for discussions (regarding the CMC-part of BLA) involving the Product or BI PHARMA KG's facilities. BI PHARMA KG shall have reasonable advance notice, if possible, of at least 30 (thirty) days before any meeting scheduled with the FDA. Any FDA and EMEA correspondence regarding the Product or facilities shall be approved by BI PHARMA KG prior to submission, such approval not to be unreasonably withheld. 2.5 ACCESS TO FACILITIES. *CONFIDENTIAL TREATMENT REQUESTED 4. 5 BI PHARMA KG shall permit COULTER and its representatives or consultants, upon reasonable prior notice to BI PHARMA KG, to audit and to review the originals of all batch records and other primary documents at its facilities [...***...] as set forth in APPENDIX 7. While at any facility, the respective COULTER personnel and its representatives or consultants shall comply with all security and safety policies and procedures of the facility owner. 3. SUPPLY 3.1 SUPPLY / PURCHASE OBLIGATIONS 3.1.1 Provided the Product is approved by the FDA to be biologically equivalent to Anti-B1 product produced by Lonza, BI PHARMA KG will manufacture and supply Product to COULTER [...***...] (where and as approved by appropriate regulatory authorities) during the full term of this Agreement. COULTER agrees to use all commercially reasonable efforts to secure such approval by the FDA and other appropriate regulatory authorities. In case the Product is not approved by the FDA to be biologically equivalent COULTER shall use all commercially reasonable efforts (including if necessary a clinical study required by the FDA) to apply for a BLA in order to qualify the BI PHARMA KG Product to be equivalent. With respect to manufacturing issues BI PHARMA KG shall use all commercially reasonable efforts to secure biological equivalence of the Product on the basis of the Process. In this case [...***...] shall be valid as of the time FDA approval of equivalence has been made. Except as set forth in Articles 3.1.2, 3.1.3 and 3.2.2 below and provided, the parties execute a Process [...***...] Agreement, COULTER will purchase and [...***...] to purchase [...***...] of Product from BI PHARMA KG throughout the world for the period of this Agreement provided, however, COULTER may, after agreement with BI PHARMA KG which shall not be unreasonably withheld, enter into an agreement with [...***...] to have such [...***...]. COULTER will collaborate with BI PHARMA KG as appropriate, with respect to the manufacturing and control section of each regulatory filing in determining the detailed regulatory filing strategy. The parties agree to a single BLA, unless mutually agreed upon otherwise. Further the parties agree to cooperate in seeking regulatory approval from the appropriate regulatory authorities in the US and with EMEA. 3.1.2 In case BI PHARMA KG is not able, despite its reasonable efforts to supply [...***...] according to the forecast system set forth in Article 3.3 below and within its respective Capacity, then COULTER shall have the right to establish and maintain [...***...] for additional material. 3.1.3 Notwithstanding anything in this Agreement, COULTER shall [...***...] to have [...***...] for [...***...] of [...***...] to be [...***...] for a [...***...]. In case registration of BI PHARMA KG as manufacturer of Product at the FDA has [...***...], the [...***...] of COULTER shall [...***...] to [...***...] for [...***...] the respective [...***...]. In case COULTER [...***...] COULTER shall use all commercially reasonable efforts to ensure that and be solely responsible for a [...***...] of BI *CONFIDENTIAL TREATMENT REQUESTED 5. 6 PHARMA KG Product [....***....] containing ANTI B1 from one source with respect to treatment of an individual patient (i. e., [...***...] of product per patient). COULTER shall indemnify and hold harmless BI PHARMA KG from any and all damages resulting from such [...***...]. 3.1.4 Subject to Article 3.2 below BI PHARMA KG undertakes to use all commercially reasonable efforts to supply COULTER with the quantities of Product ordered by COULTER according to Article 3.3 below within the Capacity. BI PHARMA KG shall use reasonable efforts to manufacture and deliver to COULTER all quantities of the Product beyond the binding forecasts within its Capacity. BI PHARMA KG shall have the option to increase the Capacity up to [...***...] (taking effect [...***...]) by giving written notice to COULTER not later than [...***...]. This option is subject to COULTER's agreement in case the forecasts laid down in Appendix 5 hereto (for the entire world) are decreased by COULTER before [...***...] by more than [...***...] for the [...***...] and the following year. 3.1.5 If there is any loss of Product because of reasons which are out of the reasonable control of the parties, then BI PHARMA KG shall use all commercially reasonable efforts to manufacture within its Capacity the missing quantities of Product at COULTER's cost. The Product Price shall be according to the scheme laid down in APPENDIX 1 (the quantity of lost Product not to be added to the quantity per year). 3.1.6 All manufacture of Product hereunder will be made in accordance with the Process, GMP, BLA and EMEA requirements and will be delivered in agreed form suitably packed as specified in the Specifications. 3.2 PRODUCTION FACILITY 3.2.1 All quantities of Product will be produced in a BI PHARMA KG production facility that has received regulatory approval by the FDA and EMEA for commercial scale production and deliveries. BI PHARMA KG shall take all commercially reasonable efforts to secure approval of BI PHARMA KG's production facility by the FDA and the EMEA and BI PHARMA KG's obligations under Article 3.1 above are subject to such approval as the case may be. BI PHARMA KG will not contract out to a third party any part of the manufacturing or the testing of Product without prior written approval from COULTER which shall not be unreasonably withheld. 3.2.2 To the extent that COULTER requests that BI PHARMA KG participate in securing regulatory approval of the manufactured Product in other countries, then BI PHARMA KG shall seek regulatory approval of its production facility unless such approval would require significant change in the production facility and/or the respective SOP's used in the manufacture of the Product. COULTER shall pay any additional costs for such approval, subject to COULTER's prior written approval. *CONFIDENTIAL TREATMENT REQUESTED 6. 7 If significant changes to the production facility are required by the respective authority and if BI PHARMA KG does not agree to make such changes at COULTER's expense, then COULTER shall have the right to [...***...]. No changes relating to the Process shall be made without the prior written consent of COULTER, such consent not to be unreasonably withheld or delayed. 3.3 ROLLING PRODUCTION FORECASTS 3.3.1 Beginning as of [...***...] and the [...***...] COULTER will provide BI PHARMA KG with a [...***...] Product forecast planning horizon for Bulk Product or an update thereof. The planning horizon shall start the first day of the [...***...] which shall be [...***...] or an [...***...] thereof. The forecasts for the [...***...] of the planning horizon [...***...] have to be given as Final Product forms [...***...] and/or Bulk Product for the remaining forecast period. 3.3.2 The forecast for [...***...] are firm orders and cannot be changed. This forecast has to be broken down to single months. The forecast for [...***...] is a partly binding forecast which means that the forecast can fully be changed within this period as follows: the forecast may be increased within the Capacity, but is limited to the following restrictions when decreased: [...***...] [...***...] The forecast for [...***...] is a non-binding forecast. The forecasts for [...***...] of the planning horizon have to be broken down quarterly. The rolling forecast system (including firm orders) for Bulk Product and Final Product are laid down in APPENDICES 2 a/b. 3.3.3 Whilst the rolling forecast system is not applicable (see Article 3.3.1 above) COULTER shall place all requirements for Bulk Product and Final Product as firm orders. 3.4 [...***...] QUANtity Beginning [...***...] for each calendar year during which Finished Product is approved for commercial sale in the United States for the entirety of such year, the [...***...] of Bulk Product to be bought by COULTER [...***...] shall be [...***...]. If the [...***...] the [...***...] of Bulk Product BI PHARMA KG will [...***...] according to Article 8.2 below. 3.5 DELIVERY / RISK OF LOSS 3.5.1 BI PHARMA KG shall make deliveries by the 10th day of the month for which a firm purchase order is made unless mutually agreed upon otherwise. *CONFIDENTIAL TREATMENT REQUESTED 7. 8 BI PHARMA KG shall deliver or arrange for the delivery of the Product purchased by COULTER to a carrier designated by COULTER on the basis of EXW BI PHARMA KG's plant in Biberach, in accordance with Incoterms 1990 as published by the International Chamber of Commerce. 3.5.2 Title to the Product sold hereunder shall pass to COULTER upon payment of invoices for Bulk Product by COULTER to BI PHARMA KG pursuant to Article 8.3.2 hereto. In the event, that BI PHARMA KG maintains inventory of Bulk Product ("Inventory") at a BI PHARMA KG facility after COULTER has been invoiced and has paid for such Bulk Product, BI PHARMA KG shall maintain such Inventory in appropriate storage conditions for Bulk Product as set forth under the BLA for Product and as laid down in the Specifications regarding shelf-life. After establishing the mutually agreed stability program BI PHARMA KG shall be [...***...] as a result of damage that occurs prior to the expiration of the shelf-life of such Inventory while such Inventory is being stored by BI PHARMA KG. BI PHARMA KG [...***...], if applicable, for [...***...] as a result of damage described in the preceding sentence [...***...]. BI PHARMA KG's liability as to risk of loss or damage during transportation of Product shall cease upon delivery of the Product in good condition to the carrier designated by COULTER at BI PHARMA KG's plant in Biberach for shipment to COULTER's designee. 3.6 SUPERIORITY No provision on COULTER's purchase order forms or in BI PHARMA KG's General Conditions of Sale which may purport to impose different conditions upon COULTER or BI PHARMA KG, nor any other modification of this Agreement, will be of any force and effect, unless in writing and signed by both parties claimed to be bound thereby. In the event of any inconsistencies, the terms of this Agreement shall govern. 4. RECORDS / DOCUMENTATION 4.1 RECORDS BI PHARMA KG shall maintain all records necessary to evidence compliance with all its obligations under this Agreement and relating to the manufacture of the Product. All such records shall be maintained for a period of not less than 3 (three) years from the date of expiration of each batch of Product to which such records pertain, or such longer period as may be required by law, rule, or regulation. Prior to the destruction of any record, BI PHARMA KG shall give written notice to COULTER which shall have the right to request, receive and retain such records with no further compensation to BI PHARMA KG. 4.2 DOCUMENTATION BI PHARMA KG shall certify in writing, that each shipment lot of Product, was produced and tested in compliance with (i) the Specifications (including the respective test methods), (ii) GMP requirements, (iii) all other applicable regulatory documents filed with the BLA and the European regulatory filings with the EMEA, if any, in accordance with procedures agreed between BI PHARMA KG and COULTER. BI PHARMA KG shall provide COULTER upon 8. 9 request with a copy of the master batch records in English as submitted with the BLA and one copy of one executed German-language batch record of one representative lot. A Certificate of Analysis appropriately signed and a Certificate of Compliance appropriately signed by BI PHARMA KG's quality assurance representative, as are necessary to demonstrate BI PHARMA KG's compliance with this Article 4.2 for each shipment lot, shall be provided to COULTER with each shipment lot from BI PHARMA KG's manufacture site. During the [..***..] audit according to Article 2.5 above, BI PHARMA KG shall provide to COULTER access to all documentation relating to facilities, equipment and the Process required to enable COULTER to evaluate BI PHARMA KG's compliance with GMP and the BLA, and the respective regulatory filing with the EMEA in the manufacture of the Product. 4.3 ADDITIONAL WORK. On request of COULTER, BI PHARMA KG shall perform additional work not currently covered by existing agreements between the parties to sustain the progress of the Project on conditions in terms of money, time and scope to be subject to mutual agreement of the parties hereto. 4.4 PROCESS [...***...] AGREEMENT BI PHARMA KG and COULTER will negotiate in good faith a Process [...***...] Agreement, subject to mutual agreement of the parties hereto on conditions to be reasonably agreeable (with regard to timing, capacity, cost) relating to the performance of additional work to sustain the progress of the Project. Such Process [...***...] Agreement shall include, but not be limited to provisions and terms relating to [...***...], and other [...***...], however the parties agree that a positive outcome can't be guaranteed. 5. QUALITY / INSPECTION OF PRODUCT / DEFECTIVE PRODUCT 5.1 TESTS OF THE PRODUCT AND AGREED UPON AUDITS COULTER shall have the right to carry out agreed upon customary tests of the Product and agreed upon annual audits (not to exceed [...***...]) at reasonable times, of the premises and facilities where BI PHARMA KG performs work under this Agreement, and of the premises where it stores raw materials, auxiliary materials, intermediates, packing materials for the Product and the Product itself. The agreed upon tests of the Product shall be included in APPENDIX 3 hereto. 5.2 LOT NUMBERING BI PHARMA KG shall be responsible for lot numbering of Bulk Product, using BI PHARMA KG's lot number system. BI PHARMA KG shall be responsible for lot numbering of all Final Product and Finished Product using BI PHARMA KG's lot numbers and lot numbering system. All details of lot numbering will be provided by BI PHARMA KG to COULTER as needed. COULTER's lot number will also be included as needed. *CONFIDENTIAL TREATMENT REQUESTED 9. 10 5.3 QUALITY CONTROL PROGRAM BI PHARMA KG shall maintain a quality control program consistent with GMP and as agreed by the parties, with respect to BI PHARMA KG's manufacture of the Product hereunder. 5.4 PRODUCT RELEASE AND QUALITY MANAGEMENT POLICY BI PHARMA KG shall be responsible for manufacturer release of Bulk Product, Final Product and Finished Product according to APPENDIX 3. Final release shall be made by and in the responsibility of COULTER, subject to the Compliance Policy of BI PHARMA KG for Biopharmaceutical Contract Manufacturing for the U.S. as described in APPENDIX 7. 5.5 RETENTION OF SAMPLES BI PHARMA KG shall retain a sufficient quantity of Product from each batch to perform [...***...] quality control tests as described IN APPENDIX 3. Retained repository samples shall be maintained in a suitable storage facility for a period of [...***...] from the date of expiration of each batch of the Product. All such samples shall be available for inspection and testing by COULTER or, at COULTER's request, COULTER's designee at reasonable times and upon reasonable notice. BI PHARMA KG shall not use these samples except for the purposes of this Agreement. 5.6 COMPLAINTS AND ADVERSE REACTIONS BI PHARMA KG shall notify COULTER immediately by telephone and not later than 5 (five) working days in writing after receipt by BI PHARMA KG's quality assurance department of any and all complaints, adverse reaction reports, safety issues or toxicity issues relating to Product (each an "Adverse Event Report"), regardless of the origin of such information, BI PHARMA KG shall advise COULTER of such Adverse Event Report. COULTER shall be responsible for adverse event notification to the respective regulatory authorities regarding all such Adverse Event Reports. COULTER's obligation to notify BI PHARMA KG immediately by telephone and no later than 5 (five) working days in writing of such Adverse Event Reports of which COULTER becomes aware shall extend only to those that may have relevance to the manufacturing and supply activities conducted by BI PHARMA KG. The parties agree to cooperate with each other and any regulatory authority in evaluating any Adverse Event Reports related to the manufacture and supply of the Product. 5.7 RECALLS ETC. COULTER shall notify BI PHARMA KG immediately by telephone and within 5 (five) working days in writing if any Product is the subject of a field alert, recall, market withdrawal or correction, and COULTER and/or its designee shall have sole responsibility for the handling and disposition of such field alert, recall, market withdrawal or correction. *CONFIDENTIAL TREATMENT REQUESTED 10. 11 BI PHARMA KG shall notify COULTER immediately by telephone and within 5 (five) working days in writing of any information of which it becomes aware which might reasonably be expected to require a field alert, recall, market withdrawal or correction relating to any Product and COULTER and/or its designee shall have sole responsibility for the handling and disposition of such field alert, recall, market withdrawal or correction. [...***...] shall bear the costs of all field alerts, recalls, market withdrawals or corrections of Product unless otherwise provided for in Article 6 hereof. [...***...] shall solely bear the direct costs incurred in connection with any such recall and [...***...] for any direct and reasonable costs incurred by [...***...] in cases where such recall was caused by [...***...] due to [...***...]. 5.8 GOVERNMENTAL CONTACTS COULTER will notify BI PHARMA KG in due time but in no event later than 5 (five) working days of any governmental contact with regard to manufacture, supply and quality control of the Product manufactured at BI PHARMA KG and, at COULTER's discretion, regarding all other Product and BI PHARMA KG shall have the right but not the obligation to participate in such meetings relating to BI PHARMA KG manufacturing and testing of the Product and approve such filings prior to submission. BI PHARMA KG will be responsible for any reporting of matters regarding the manufacture of Product to the FDA and EMEA in accordance with pertinent laws and regulations of the respective countries, and will keep Coulter informed and provide COULTER with a copy of such reports not later than the time they are filed. BI PHARMA KG shall be responsible for handling and responding to any appropriate German governmental agency or other regulatory authorities inspections with respect to the manufacturing of the Product. BI PHARMA KG shall provide to COULTER any information reasonably requested by COULTER and all information correspondence and reports prepared by any governmental agency or by BI PHARMA KG in connection with the Product. BI PHARMA KG shall advise COULTER in due time of any requests by any governmental agency for such inspections and shall - at its sole discretion -permit COULTER or its representative to attend such inspections/audits concerning the Product. Notwithstanding anything in this Article 5.8 COULTER shall be permitted to be onsite at BI PHARMA KG for Product specific briefings and debriefings of the audit, if any. 5.9 DEFECTIVE PRODUCT (INCLUDING LOSS AND INACCURATE QUANTITY) 5.9.1 Claims on account of quantity, quality (i.e. compliance with Specifications), loss or damages to the Product shall be made by COULTER in writing within [...***...] following receipt thereof, and BI PHARMA KG's liability for damages resulting therefrom shall [...****...] for the particular shipment with respect to which such claims are made. No Product will be returned to BI PHARMA KG without BI PHARMA KG's written permission. 5.9.2 If COULTER claims that any shipment of Product did not at time of delivery meet the Specifications, BI PHARMA KG shall conduct an assay of its retained sample from such shipment. If BI PHARMA KG agrees with COULTER's claim or if the Third Party Firm (as *CONFIDENTIAL TREATMENT REQUESTED 11. 12 defined in Article 5.9.3 below) agrees with COULTER's claim and if BI PHARMA KG has Product in existing stock, BI PHARMA KG shall replace such shipment of Product [...***...] of COULTER's notice or the Third Party Firm's determination. If BI PHARMA KG agrees with COULTER's claim or the Third Party Firm agrees with COULTER's claim but BI PHARMA KG does not have Product in existing stock, then at COULTER's option, BI PHARMA KG shall [...***...]. BI PHARMA KG shall give COULTER written instructions as to how COULTER should, at BI PHARMA KG's expense, either dispose of the non-conforming material or return it to BI PHARMA KG, and such instructions shall comply with all appropriate governmental requirements. 5.9.3 If the parties are unable to resolve their differences, then either party may refer the matter to an independent specialized firm of international reputation agreeable to both parties (the "Third Party Firm") for final analysis, which shall be binding on both parties hereto. An additional set of quality control samples will be generated to ensure that 2 (two) full sets of retention samples are available should the lot be released. Any dispute resolution shall not release BI PHARMA KG from its obligation to manufacture the required quantities of Product according to the rolling forecast system and the Capacity. 5.10 BI PHARMA KG certifies it has not knowingly and will not knowingly use in any capacity the services of any person, including any firm or individual, debarred or subject to debarrment under the United States Generic Drug Enforcement Act of 1992. BI PHARMA KG agrees to notify COULTER immediately in the event it becomes aware of any person providing services to BI PHARMA KG under the scope of the work of this Agreement who is debarred or becomes subject to debarrment. 6. WARRANTY / LIMITATION / INDEMNIFICATION 6.1 WARRANT BI PHARMA KG warrants and represents that the Product to be supplied by BI PHARMA KG hereunder including any labeling and other packaging if any for such Product corresponds to the Specifications and shall be produced, handled, stored, labeled, packaged according to GMP standard, and all applicable laws and regulations of Germany, and has been produced consistent with the Process. The Product shall be delivered free and clear of liens and claims which affect title. 6.2 LIMITATION OF WARRANTY / LIABILITY Except as provided in Article 6.1 above BI PHARMA KG makes no warranty of any kind, express or implied. BI PHARMA KG shall be liable for [...***...] and, except for [...***...], BI PHARMA KG shall [...***...]. 6.3 INDEMNIFICATION BY COULTER COULTER shall indemnify, defend and hold BI PHARMA KG, its affiliates, and their respective officers, employees and agents harmless from any damage, loss, cost or expense [...****...] relating to third party claims or suits, including injury to persons or damage to property arising from the packaging, use, *CONFIDENTIAL TREATMENT REQUESTED 12. 13 marketing or sale of the Product by COULTER, or its licensees or other authorized persons or entities, which (i) [...***...], or (ii) [...***...] and provided that upon receipt of notice by BI PHARMA KG of any claims or suits relating to such use or sale of the Product. BI PHARMA KG shall notify COULTER thereof without delay and shall permit COULTER to handle such claims or suits at the cost and [...***...] including but not limited to defense, settlement and compromise thereof. 6.4 INDEMNIFICATION BY BI PHARMA KG To the extent provided for in this Article 6 BI PHARMA KG shall indemnify, defend and hold COULTER, its affiliates, licensee(s) and their respective officers, employees and agents harmless from any damage, loss, cost or expense [...***...] relating to third party claims or suits, including injury to persons or damage to property arising from BI PHARMA KG's activities under this Agreement which (i) [...***...] (ii) [...***...] and provided that [...***...] by COULTER of any claims or suits relating to such use or sale of the Product, COULTER shall notify BI PHARMA KG thereof without delay and shall permit BI PHARMA KG to handle such claims or suits at the cost and [...***...] including but not limited to defense, settlement and compromise thereof. 6.5 YEAR 2000 BI PHARMA KG is currently working to ensure that the functionality and performance of the Biberach facility and the computer systems and computer programs which affect or may affect the manufacturing or testing of Product hereunder will not be affected by dates prior to, during and after the year 2000. BI PHARMA KG shall use all commercially reasonable efforts to ensure that it will be able to fulfill the firm orders within the Capacity under this Agreement prior to, during and after the year 2000. 6.6 [...***...] AMOUNT Except as set forth in Section 5.9, BI PHARMA KG's [...***...] under this Agreement shall [...***...] the [...***...] from [...***...] and/or COULTER's [...***...] of the respective calendar year. 7. SUPPORT REGARDING POST LICENSING ISSUES BI PHARMA KG agrees to support COULTER and its licensee(s), if applicable, with regard to post licensing issues (e. g. possible registration issues in the various countries) on commercially reasonable conditions to be agreed upon, [...***...]. 8. PRICE AND PAYMENT 8.1 PRODUCT PRICE The Product Price for the Product shall be calculated according to the scheme laid down in APPENDIX 1. *CONFIDENTIAL TREATMENT REQUESTED 13. 14 8.2 SURCHARGE If COULTER elects not to order for purchase [...***...] of Product in a [...***...] (i.e. [...***...] are [...***...]) as set forth in Article 3.4 above, COULTER shall [...***...] according to [...***...]. In case BI PHARMA KG is not able to manufacture and supply for sale the [...***...] of Product in a given calendar year, then COULTER [...***...] according to the [...***...]. 8.3 INVOICING AND PAYMENT CONDITIONS 8.3.1 INVOICING For Bulk Product, BI PHARMA KG will release (manufacturer release) Bulk Product, issue a Certificate of Analysis and send an invoice to COULTER. For sterile liquid fill services as described in APPENDIX 1, BI PHARMA KG will release (manufacturer release) Finished Product or Final Product, issue a Certificate of Analysis and send an invoice to COULTER. 8.3.2 PAYMENT Upon receipt of an invoice from BI PHARMA KG pursuant to Article 8.3.1 above by COULTER, COULTER will pay within [...***...]. The Product Price for Product delivered to COULTER or according to COULTER's instructions shall be payable by COULTER within 30 (thirty) days after deliver of Product to the respective party in DEM (Deutsche Mark) by wire transfer to an account to be nominated by BI PHARMA KG. The surcharge according to Article 8.2 above shall be payable within 30 (thirty) days after receipt of the respective invoice. 8.4 PRODUCT PRICE ADJUSTMENTS 8.4.1 The Product Price set forth in Article 8.1 above [...***...] will be [...***...] effective at [...***...] per year for [...***...]. BI PHARMA KG shall notify COULTER of any [...***...] prior to the date such [...***...] becomes effective. 8.4.2 In case any [...***...] (in terms of [...***...] or [...***...] for producing Bulk Product, Final Product and/or Finished Product) [...***...] in a given calendar year, which the requesting party must demonstrate, the parties shall agree upon the [...***...] based on good faith negotiations. This amount to be [...***...] respectively to [...***...] within [...***...] of agreement and [...***...]. Thereafter on [...***...]. 8.4.3 In case that a change of the Process and/or of the Specifications influences the basic production assumptions set forth in Appendix 1 the Product Price shall be recalculated according to the scheme for determining the Product Price. 8.4.4 COULTER may elect whether the [...***...] according to Article 8.4.2 above is payable pursuant to a separate invoice or by [...***...] for Bulk Product, Final Product and/or Finished Product. If COULTER can demonstrate to BI PHARMA KG that any materials used for producing Bulk Product, *CONFIDENTIAL TREATMENT REQUESTED 14. 15 Final Product and/or Finished Product can be [...***...] and [...***...] and on a regular basis than BI PHARMA KG's [...***...], then BI PHARMA KG shall accept[...***...] for purposes of Article 8.4. Such [...***...] must be available on a regular basis and the same quality as the materials used by BI PHARMA KG. 8.4.5 Changes of the Process and the Specifications due to the activities performed under the intended Process [...***...] Agreement may influence the Product Price and the parties shall negotiate in good faith a new Product Price. 8.4.6 The Product Price shall also be valid for any change in quantity during the respective firm order period. However a price recalculation shall take place if [...***...] will be [...***...] effective as agreed upon by the parties. 8.5 CURRENCY All payments will be made in DEM. "Deutsche Mark" or "DEM" means the lawful currency for the time being of Germany or, in case of the implementation of the European Monetary Union, the Euro on the basis of the official conversion rate. 8.6 EURO In the event the initial conversion to the Euro will result in a Product Price increase of [...***...] within [...***...] after that initial conversion, the parties will meet and negotiate in good faith a solution to the issue of a Product Price in crease due to such conversion. 9. CONFIDENTIALITY 9.1 BI PHARMA KG BI PHARMA KG shall not disclose COULTER Confidential Information to any person other than its employees or employees of affiliated companies of the Boehringer Ingelheim group who have a need to know such information in order to perform their duties in carrying out the work hereunder and who have an obligation to maintain the confidentiality thereof under terms at least as stringent as those provided herein. 9.2 COULTER COULTER shall not disclose any BI PHARMA KG Confidential Information to any person other than 9.2.1 its employees or consultants who are bound by similar obligations of confidentiality and who have a need to know such information in order to provide direction to BI PHARMA KG or evaluate the results of the work, or COULTER's licensee(s), if applicable, solely for regulatory purposes and only if such licensee(s) have an obligation to maintain the confidentiality thereof under the terms at least as stringent as those provided herein, or 9.2.2 regulatory authorities, for example, the FDA or foreign equivalent, that require such information in order to review an IND, BLA or other regulatory filing. BI PHARMA KG will *CONFIDENTIAL TREATMENT REQUESTED 15. 16 be informed and must agree prior to filing of any Bl PHARMA KG Confidential Information to regulatory authorities. In these cases where BI PHARMA KG restricts COULTER's ability to file BI PHARMA KG Confidential Information, BI PHARMA KG agrees to provide the Confidential Information directly to the regulatory authorities and will provide a letter of authorization for cross-reference to COULTER. 9.2.3 persons or entities that manufacture Product for COULTER after termination of this Agreement or during this Agreement as permitted herein and who have an obligation to maintain the confidentiality thereof under terms at least as stringent as those provided herein. 9.3 EXCEPTIONS The obligations of confidentiality applicable to COULTER Confidential Information and BI PHARMA KG Confidential Information shall not apply to any information that is: (1) known publicly or becomes known publicly through no fault of the recipient; (2) learned by the recipient from a third party entitled to disclose it; (3) developed by the recipient independently of information obtained from the disclosing party; (4) already known to the recipient before receipt from the disclosing party, as shown by its prior written records; (5) required to be disclosed by law, regulation or the order of a judicial or administrative authority; or (6) released with the prior written consent of the disclosing party. 9.4 OTHERS The obligations of both parties under this Article 9 shall expire ten (10) years after expiration or termination of this Agreement. 9.5 DISCLOSURE TO THE SECURITIES AND EXCHANGE COMMISSION In the event Securities and Exchange Commission ("SEC") rules or regulations require COULTER to disclose BI PHARMA KG's Confidential Information, COULTER shall provide to BI PHARMA KG a reasonable opportunity to comment on such disclosures and shall thereafter promptly inform BI PHARMA KG regarding any such disclosure. 10. LICENSE 10.1 LICENSE TO USE OF COULTER CELL LINE AND INTELLECTUAL PROPERTY COULTER hereby grants BI PHARMA KG a [...***...] right and license to use the Cell Line and COULTER Confidential Information solely for the purposes of this Agreement. *CONFIDENTIAL TREATMENT REQUESTED 16. 17 10.2 LICENSE TO USE OF BI PHARMA KG'S INTELLECTUAL PROPERTY BI PHARMA KG hereby grants COULTER a [...***...] license, [...***...] under this Agreement in connection with the Cell Line, the Process and/or the Product, to use, sell, offer for sale and import Product. Except as provided for in Article 3.1 above this license shall extend to the Process for production of the Product after regular expiration of this Agreement only. 10.3 NO ADDITIONAL LICENSES Except as granted under this Agreement, no right or license, either express or implied, under any patent or proprietary right is granted hereunder by virtue of the disclosure of COULTER Confidential Information or BI PHARMA KG Confidential Information. 11. TERM AND TERMINATION 11.1 TERM; EXTENSION This Agreement will come into force and effect as of the Effective Date, and shall remain valid until [...***...] (the "Initial Term"). It will automatically extend for additional [...***...] year periods in the absence of a written notice of termination by one of the parties to the other. Such written notice shall be given no later than [...***...] years prior to the end of the Initial Term and/or any extension period. 11.2 EARLY TERMINATION 11.2.1 To the extent permitted by law, if either party shall become insolvent or shall make assignment for the benefit of creditors, or proceedings in voluntary bankruptcy shall be instituted on behalf of or against a party or a receiver or trustee of all, or substantially all of the property of a party shall be appointed, the other party shall be entitled to terminate this Agreement by giving written notice to this effect to the first party whereupon this Agreement shall so terminate, unless such situation is rectified within a period of 60 (sixty) days. 11.2.2 Either party may terminate this Agreement for any material breach of this Agreement, if such breach is not cured within 60 (sixty) days following receipt by the party committing the breach of written notice of the intent to terminate. Such termination shall become effective immediately upon further notice to the defaulting party. 11.2.3 This Agreement may be terminated by COULTER at any time if COULTER shall withdraw the Product from the US market. In this case COULTER will pay to BI PHARMA KG the Product Price for the firm ordered quantities (see Article 3.3 above) of the Product. Moreover, COULTER will pay to BI PHARMA KG [...***...] as follows: for the [...***...] (which is [...***...]) COULTER will pay [...***...] (according to [...***...])[...***...] [...***...] [...***...] *CONFIDENTIAL TREATMENT REQUESTED 17. 18 These payments shall be due [...***...] after receipt by BI PHARMA KG of the notice of premature termination from COULTER and receipt by COULTER of the respective invoice from BI PHARMA KG. 11.2.4 COULTER shall have the right to terminate this Agreement upon the date when [...***...] increases to [...***...] according to APPENDIX 1. 11.3 INTRODUCTION OF THE EURO The introduction of the Euro as the legal currency or legal tender in Germany (see Articles 8.5 and 8.6 above) shall in no way affect the validity of this Agreement and shall not entitle any party hereto to terminate, or to require any amendment to, this Agreement. 11.4 EFFECT OF TERMINATION Upon the expiration or termination of this Agreement: 11.4.1 At the request of COULTER, BI PHARMA KG shall either destroy the Cell Line as well as the material derived from its culture or deliver the same to COULTER or a party nominated by COULTER [...***...] and shall promptly return all COULTER Confidential Information to COULTER; except for a single copy and/or sample of each material for documentation purposes only. BI PHARMA KG'S responsibility to keep and store the Cell Line and any other materials shall terminate six (6) months after expiration or termination of this Agreement and 11.4.2 COULTER shall promptly return all BI PHARMA KG Confidential Information to BI PHARMA KG, except for a single copy and/or sample for documentation purposes only. The respective rights of BI PHARMA KG and COULTER to indemnification as set forth in Article 6 hereof and Articles 4.1 and 5.5 shall survive termination of this Agreement with respect to any claims that relate to or derive from the Project, or any acts or failures to act, of either BI PHARMA KG or COULTER in connection with the Project that occur prior to termination. Article 9 shall survive termination of this Agreement as laid down herein. 12. MISCELLANEOUS 12.1 FORCE MAJEURE. Neither party shall be in breach of this Agreement if there is any failure of performance under this Agreement occasioned by any act of God, fire, act of government or state, war, civil commotion, insurrection, embargo, prevention from or hindrance in obtaining energy or other utilities, labor disputes of whatever nature or any other reason beyond the control of either party. In the event the Force Majeure lasts 1 (one) year, the other party may terminate this Agreement. 12.2 PUBLICITY. Except as required by law, no press release or other form of publicity regarding the work performed hereunder or this Agreement shall be permitted by either party to be published unless both parties have indicated their consent to the form of the release in writing. *CONFIDENTIAL TREATMENT REQUESTED 18. 19 12.3 NOTICES. Any notice required or permitted to be given hereunder by either party shall be in writing and shall be (i) delivered personally, (ii) sent by registered mail, return receipt requested, postage prepaid or (iii) delivered by facsimile with immediate telephonic confirmation of receipt, to the addresses or facsimile numbers set forth below: If to BI PHARMA KG: Boehringer Ingelheim Pharma KG Birkendorfer Strasse 65 88397 Biberach an der Riss Federal Republic of Germany Attention: Dr. Wolfram Carius (cc: Dr. Wolfgang Noe) Fax: ++49 73 51/54-4862 Phone: ++49 73 51/54-5134 If to COULTER: Coulter Pharmaceutical Inc. 550 California Avenue, Suite 200 Palo Alto, California 94306-1440 U.S.A., Attention: Vice President, Manufacturing (cc: Chief Financial Officer Fax: 001-650-849-7500 Phone: 001-650-849-7530 Each notice shall be deemed given (i) on the date it is received if it is delivered personally, (ii) one (1) day after the date it is postmarked if it is sent by certified United States mail, return receipt requested, postage prepaid or (iii) on the date it is received if it is sent by facsimile with immediate telephonic confirmation of receipt. 12.4 APPLICABLE LAW/JURISDICTION This Agreement shall be governed by and construed in accordance with the laws of the place of domicile of the party sued and the courts of the place of domicile of the party sued shall have exclusive jurisdiction over all legal matters and proceedings hereunder. 12.5 COMPLIANCE WITH LAWS BI PHARMA KG shall perform the work hereunder in conformance with GMP, as applicable, and all German and/or European Economic Community (EEC) laws, ordinances and governmental rules or regulations pertaining thereto. 12.6 INDEPENDENT CONTRACTORS Each of the parties hereto is an independent contractor and nothing herein contained shall be deemed to constitute the relationship of partners, joint venture, nor of principal and agent between the parties hereto. Neither party shall hold itself out to third persons as purporting to act on behalf of, or serving as the agent of, the other party. 12.7 WAIVER No waiver of any term, provision 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 19. 20 continuing waiver of any such term, provision or condition or of any other term, provision or condition of this Agreement. 12.8 SEVERABILITY If any provision of this Agreement is held to be invalid or unenforceable by a court of competent jurisdiction all other provisions shall continue in full force and effect. The parties hereby agree to attempt to substitute for any invalid or unenforceable provision a valid or enforceable provision which achieves to the greatest extent possible the economic, legal and commercial objectives of the invalid or unenforceable provision. 12.9 ENTIRETY This Agreement, including any exhibits and appendices attached hereto and referenced herein, constitutes the full understanding of the parties and a complete and exclusive statement of the terms of their agreement, and no terms, conditions, understandings or agreements purporting to modify or vary the terms thereof shall be binding unless they are hereafter made in writing and signed by both parties. 12.10 ASSIGNMENT This Agreement shall be binding upon the successors and assigns of the parties and the name of a party appearing herein shall be deemed to include the names of its successors and assigns provided always that nothing herein shall permit any assignment by either party, except as BI PHARMA KG may assign this Agreement to an affiliated company taking over the operative biotech business of BI PHARMA KG and COULTER may assign in the case of a merger or acquisition or transfer of its assets related to this Agreement. 20. 21 IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized representatives on the day and year first above written. COULTER PHARMACEUTICAL, INC. BOEHRINGER INGELHEIM PHARMA KG PPA. PPA. /s/ WILLIAM G. HARRIS /s/ DR. WOLFRAM CARIUS /s/ PROF. ROLF WERNER - ---------------------------- ---------------------------- ------------------------------- Vice President and CFO Dr. Wolfram Carius Prof. Rolf Werner (Head of Biopharmaceutical (Head of Industrial Manufacture) Biopharmaceuticals world-wide)
Appendix 1: Product Price and Basic Production Assumptions Appendix 2 a: Firm Orders (preapproval phase) Appendix 2 b: Rolling Forecast (post approval phase) Appendix 3: Specifications for Product Appendix 4: Manufacturing Project Managers and Manufacturing Project Team Members Appendix 5: Manufacturing Forecast Appendix 6: Certificate of Compliance Appendix 7: Compliance Policy of BI PHARMA KG for Biopharmaceutical Contract Manufacturing for the U.S. 21. 22 Boehringer Ingelheim APPENDIX 7 COMPLIANCE POLICY OF BI PHARMA KG FOR BIOPHARMACEUTICAL CONTRACT MANUFACTURING FOR THE US Goal: To define BI policy for establishing compliance oversight for contract manufacturing of products were the third party is the owner of a product for marketing in the United States of America. Several measures are offered by BI to a third party in order to establish compliance oversight of the license holder over its product manufactured at BI: 1.0 CONTRACT The basic GMP Compliance aspects are laid down in a written contract between the parties (license holder and BI). 2.0 AUDITS The license holder has the right to conduct annual audits at the facilities of BI to inspect GMP-status of the facility with respect to its product. BI is committed to resolve relevant GMP- deficiencies observed by the license holder or is consultants. 3.0 DOCUMENT CONTROL/APPROVAL 3.1 Master Batch Records The license holder has to approve the master batch records for commercial production of its product. All changes of the batch records which impact regulatory filings identified by BI QA require written approval of the license holder prior to revision of the batch records and implementation of the changes. 3.2 Testing Records The license holder has to approve the product specific testing records for manufacturer release testing of its product. All changes of the records which impact regulatory filings identified by BI QA require written approval of the license holder prior to revision of the document. 3.3 Process and Method Validation The license holder has to approve the validation for process and method validation. 22. 23 Appendix 6 Boehringer Ingelheim CERTIFICATE OF COMPLIANCE Page 1 of 1 PRODUCT: Lot No.: MANUFACTURING DATE: EXPIRATION DATE: It is hereby certified that all manufacturing documents including batch manufacturing records and in-process control sheets have been inspected and found to be in compliance with current specifications and that the analyses carried out in our control laboratory have revealed the results of the attached analytical certificates and are in compliance with current specifications. If occurred, deviations during manufacturing and testing of the product are documented in the batch manufacturing and testing records and have been assessed and found to be acceptable. The batch was manufactured in accordance with cGMP's and with the product's. The lot is approved and released. BOEHRINGER INGELHEIM PHARMA KG QUALITY ASSURANCE Signature: ------------------------ Date: ----------------------------- (day/month/year) 23. 24 Boehringer Ingelheim 4.0 PRODUCT RELEASE 4.1 BI-Manufacturers release Bl certifies to the license holder that manufacturing and testing of a batch has been performed according cGMP and according the BLA. BI certifies the analytical results of a batch. BI provides a summary of all deviations which might have occurred during manufacturing and testing. 4.2 Final product release The final release of product for marketing is the responsibility of the license holder. 5.0 FACILITY CHANGES BI notifies the license holder of significant facility changes. 24. 25 Appendix 5 Manufacturing Forecast for Coulter B 1 Therapy Years [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] US Demand [...***...] [...***...] [...***...] [...***...] [...***...] European Demand [...***...] [...***...] [...***...] [...***...] [...***...] Total Demand [...***...] [...***...] [...***...] [...***...] [...***...] Assumes: [...***...] [...***...]
*CONFIDENTIAL TREATMENT REQUESTED 25. 26 Appendix 4 MASTER-PROJECT PLAN: ANT-B1 COULTER PHARMACEUTICALS INC./B1 PHARMA KG MANUFACTURING PROJECT MANAGERS AND MANUFACTURING PROJECT TEAM MEMBERS [...***...] *CONFIDENTIAL TREATMENT REQUESTED 26. 27 Appendix 3.1 Product Specification Doc. Number: PSP/PCP XXXXX ANTI-B1 ANTIBODY BULK Effective Date: DRAFT Manufactured by BI Pharma KG Page Number: 1 of 3 PRODUCT DESCRIPTION Purified Monoclonal Antibody Bulk directed against CD20 Antigen formulated in [...***...] PART NUMBER: LOT NUMBER: Storage Conditions [...***...] MANUFACTURER: THOMAE MANUFACTURE DATE EXPIRATION DATE [...***...] ATTRIBUTE TEST METHOD Specification Quality [...***...] [...***...] [...***...] Identity [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] Composition [...***...] [...***...] [...***...] Purity [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] Potency [...***...] [...***...] [...***...] Safety [...***...] [...***...] [...***...] [...***...] [...***...] [...***...]
*CONFIDENTIAL TREATMENT REQUESTED 27. 28 Appendix 3.1 FOR INFORMATION ONLY ATTRIBUTE TEST METHOD SPECIFICATION [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...]
*CONFIDENTIAL TREATMENT REQUESTED 28. 29 Appendix 3.2 FOR INFORMATION ONLY
ATTRIBUTE TEST METHOD SPECIFICATION [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] POTENCY [...***...] [...***...] [...***...] SAFETY [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...]
Product Specification Doc. Number PSP/PCA ANTI-B1 ANTIBODY FINAL BAGGED PRODUCT XXXX for further manufacturing Effective Date: DRAFT Manufactured by BI Pharma KG Page Number: 1 of 3 PRODUCT DESCRIPTION Purified Monoclonal Antibody directed against CD20 Antigen formulated in [...***...] PART NUMBER: LOT NUMBER: STORAGE CONDITIONS [...***...] MANUFACTURER: THOMAE MANUFACTURE DATE EXPIRATION DATE [...***...] ATTRIBUTE TEST METHOD SPECIFICATION QUALITY [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] IDENTITY [...***...] [...***...] [...***...] [...***...] [...***...] [...***...]
*CONFIDENTIAL TREATMENT REQUESTED 29. 30 COMPOSITION [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] PURITY [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] Product Specification Doc. Number: PSP/PCA ANTI-BI ANTIBODY FINAL VIALED PRODUCT xxxx Manufactured by BI Pharma KG Effective Date: DRAFT Page Number; 1 of 2 PRODUCT DESCRIPTION: Purified Monoclonal Antibody directed against CD20 Antigen formulated in [...***...] ATTRIBUTE TEST METHOD SPECIFICATION QUALITY [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] IDENTITY [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] COMPOSITION [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] PURITY [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] POTENCY [...***...] [...***...] [...***...]
*CONFIDENTIAL TREATMENT REQUESTED 30. 31 SAFETY [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...]
*CONFIDENTIAL TREATMENT REQUESTED 31. 32 Appendix 3.3
FOR INFORMATION ONLY ATTRIBUTE TEST METHOD SPECIFICATION [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...]
*CONFIDENTIAL TREATMENT REQUESTED 32. 33 Appendix 2a FIRM ORDER PLANNING SYSTEM OF ANTI-B1 COMMERCIAL SUPPLY PRE FDA APPROVAL
Year [......***.....] [..........*******...........]
[...***...] *CONFIDENTIAL TREATMENT REQUESTED 33. 34 Appendix 2b ROLLING FORECAST PLANNING SYSTEM OF BULK PRODUCT AND FINAL PRODUCT ANTI-B1 COMMERCIAL SUPPLY
1998 1999 2000 2001 2002 IQ IIQ IIIQ IVQ IQ IIQ IIIQ IVQ IQ IIQ IIIQ IVQ IQ IIQ IIIQ IVQ IQ IIQ IIIQ IVQ
[...***...] *CONFIDENTIAL TREATMENT REQUESTED 34. 35 Appendix 1 Page 1 of 2 Master Project plan : ANTI B1 COULTER PHARMACEUTICAL BI Pharma KG Basic Production Assumptions and Pricing System for Commercial Supply BASIC PRODUCTION ASSUMPTIONS OF BULK DRUG SUBSTANCE Scale [...***...] Titer [...***...] Overall Yield [...***...] Total amount per run [...***...] PRICE [...***...] Quantity per year Price [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] [...***...] STERILE LIQUID FILL [...***...] Batch Size [...***...] Final Dosage [...***...] Fill Volume [...***...] Price [...***...] [...***...] STERILE LIQUID FILL [...***...] Batch Size [...***...] Final Dosage [...***...] Fill Volume [...***...] Price[...***...] [...***...] FILL [...***...] Bulk Drug Substance approximately [...***...] Fill Volume [...***...] Price [...***...] [...***...]
*CONFIDENTIAL TREATMENT REQUESTED 35. 36 APPENDIX 1 PAGE 2 OF 2 Master Project plan : Anti B1 COULTER PHARMACEUTICAL / BI Pharma KG Basic Production Assumptions and Pricing System for Commercial Supply S = SURCHARGE The surcharge system is effective, [...***...] If the annual placed firm order Quantity falls below [...***...], BI Pharma KG will charge [...***...] Calculated as follows: [...***...] [...***...] Surcharge= [...***...] PRICE CALCULATION FINAL PRODUCT PB= Bulk Drug price [...***...] [...***...] Price = [...***...] [...***...] Price = [...***...] BAG OR APPROPRIATE CONTAINER FILL [...***...] Price = [...***...] *CONFIDENTIAL TREATMENT REQUESTED
EX-10.27 8 1ST AMENDMENT TO LEASE AGREEMENT W/HMS GATEWAY 1 Exhibit 10.27 ***Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4), 200.83 and 240.24b-2 FIRST AMENDMENT TO LEASE AGREEMENT THIS FIRST AMENDMENT TO LEASE AGREEMENT (this "Amendment") is made as of November 10, 1998, by and between HMS GATEWAY OFFICE L.P., a Delaware limited partnership ("Landlord"), and COULTER PHARMACEUTICAL, INC., a Delaware corporation. ("Tenant"). RECITALS A. Landlord and Tenant have previously entered into that certain Lease Agreement dated November 7, 1997 (the "Lease"). B. Pursuant to the Lease, Tenant leased from Landlord approximately [...***...]* square feet (the "Original Premises"), which Original Premises constitute the entire building commonly known as 600 Gateway Boulevard, South San Francisco, California (the "Building"). C. Landlord and Tenant desire to amend the Lease to reflect the expansion of the Original Premises, all upon and subject to the terms, covenants and conditions hereinafter set forth. AGREEMENT NOW THEREFORE, in consideration of the agreements of Landlord and Tenant herein contained and other valuable consideration, the receipt and adequacy of which are hereby acknowledged, Landlord and Tenant hereby agree as follows: 1. DEFINED TERMS. Except as otherwise defined herein, capitalized terms shall have the meaning ascribed to them in the Lease. 2. PREMISES. Landlord shall lease to Tenant, and Tenant shall lease from Landlord, the Premises on the terms and conditions set forth in the Lease and herein. From and after the Expansion Space Commencement Date (as defined in Exhibit B-FA attached hereto), the Premises shall mean the Original Premises and an additional approximately [...***...] square feet (the "Expansion Space"), which Expansion Space shall constitute the entire building to be conducted in accordance with Exhibit A-FA and Exhibit B-FA hereto and to be commonly known as 650 Gateway Boulevard, South San Francisco, California (the "Expansion Building"). 1. 2 3. MONTHLY BASE RENT FOR THE EXPANSION SPACE. Monthly Base Rent for the Expansion Space shall, as of the Expansion Space Commencement Date, be [...***...]* to the applicable rate per square foot being charged from time to time under the Lease for the Original Premises multiplied by the square footage of the Expansion Space. The rate per square foot being charged under the Lease for the Original Premises shall be determined by dividing the Monthly Base Rent due for the Original Premises by the Premises Square Footage for the Original Premises. Nothing in this Paragraph 2 shall alter or amend the Monthly Base Rent payable under the Lease for the Original Premises. 4. TENANT'S PROPORTIONATE SHARE; PARKING. As of the Expansion Space Commencement Date and subject to the terms and conditions set forth in the Lease, (i) Tenant's Proportionate Share of the Project shall be [...***...], (ii) Tenant's Proportionate Share of the Building shall remain 100% and (iii) the number of unreserved parking spaces shall be increased to [...***...] non-exclusive and undesignated parking spaces. 5. SECURITY DEPOSIT. Prior to execution of this Amendment and in satisfaction of the condition set forth in Paragraph 52 of the Lease, Tenant has increased the Security Deposit by [...***...] such that the total Security Deposit held by Landlord under the Lease is [...***...]. Such increased Security Deposit is subject to the terms and conditions of the Lease, including without limitation, Paragraph 7 of the Lease. 6. EXPANSION CONSTRUCTION AGREEMENTS. Attached hereto as Exhibit A-FA and Exhibit B-FA, respectively, are the Expansion Construction Agreements that set forth the rights and obligations of Landlord and Tenant with respect to the construction of the Expansion Building and the Expansion Space. These Expansion Construction Agreements amend and restate the Base Building Construction Agreement and the Premises Construction Agreement currently attached to the Lease with respect to the construction of the Expansion Building and Expansion Space only. 7. TIME FOR PERFORMANCE. With respect to construction of the Expansion Space, the parties have set forth on Exhibit H-FA hereto certain events which must occur prior to or during the construction of the Expansion Space (each a "Condition"), together with certain dates upon which each condition must be satisfied ("Initial Window Date"); provided however, if Landlord is delayed in satisfying any Condition due to Tenant Delays or Force Majeure Events (as defined in Exhibit B-FA hereto), all of the Initial Window Dates set forth on Exhibit H-FA shall be extended for a period equal to the length of such delay. If any Condition is not satisfied on or before its respective Initial Window Date, as such may be so extended, Tenant shall have the right to terminate this Lease, as to both the Original Premises and Expansion Space, by delivering written notice to 2. 3 Landlord within [...***...]* business days after expiration of the applicable Initial Window Date. If Tenant does not deliver written notice of termination to Landlord within such [...***...] period, time being of the essence, Tenant shall have waived its right to terminate as a result of Landlord's failure to satisfy the particular Condition in question. If Tenant timely elects to terminate the Lease as set forth above, the Lease, as to the Original Premises and the Expansion Space, shall terminate. If Tenant timely exercises its right to terminate the Lease as provided above, Landlord shall have the right to nullify Tenant's election to terminate the Lease as to the Original Premises by notifying Tenant, within [...***...] days after receipt of Tenant's election to terminate, of Landlord's election to pay to Tenant the Relocation Costs (as defined below). In the event Landlord nullifies Tenant's election to terminate the Lease as to the Original Premises and Tenant (i) gives Landlord written notice within [...***...] months of such nullification that Tenant will vacate the Original Premises and (ii) vacates the Original Premises, Tenant shall have the right to sublease the Original Premises as otherwise provided under Paragraph 23 of the Lease; provided however, Tenant, in this instance, shall not be required to pay the Additional Rent required to be paid to Landlord under Paragraph 23(c) of the Lease. Notwithstanding this paragraph, Tenant and any guarantor or surety of Tenant's obligations under the Lease shall at all times remain fully responsible and liable for payment of the Rent and for compliance with all of Tenant's obligations under the Lease, as provided in Paragraph 23(d) of the Lease. "RELOCATION COSTS" are defined as [...***...] of the reasonable out-of-pocket costs that Tenant incurs to relocate from the Original Premises to a new location. Relocation Costs shall not include any payment of rent or any cost of tenant improvements. Prior to reimbursement of Relocation Costs by Landlord, Tenant shall provide Landlord with back-up invoices evidencing the costs incurred by Tenant in relocating to Tenant's new location. In no event shall Landlord pay Relocation Costs in excess of [...***...]. Relocation Costs shall be paid by Landlord within [...***...] days after receipt of the above-referenced back-up invoices. 8. CARRY COSTS. Notwithstanding anything in Paragraph 52(e) of the Lease to the contrary, except for any delays in the Phase II Commencement Date due to Force Majeure Events, Tenant shall continue to pay to Landlord the Carry Costs on the first day of each month up to and including [...***...]. In the event of a delay in the Phase II Commencement Date due to Force Majeure Events, Tenant shall continue payment (prorated as appropriate) of Carry Costs for the time attributable to such delay. 9. TENANT MAINTENANCE. Notwithstanding anything in the Paragraph 13 of the Lease to the contrary, Tenant shall be responsible for maintaining the heating, ventilating and air-conditioning systems and the life-safety systems serving the Premises. Tenant shall maintain these systems in good order and condition and shall, at a minimum, follow Landlord's standard servicing guidelines for such systems. 3. 4 10. R&D SPACE. Notwithstanding anything in Paragraph 11 of the Lease to the contrary, Tenant shall be permitted [...***...]* square feet of R&D Space in the Expansion Space. Tenant may not exceed such maximum square footage for R&D Space in the Expansion Space and therefore no Conversion Allowance shall be payable by Tenant nor shall any Converted Office Space be available to Tenant with respect to the Expansion Space. The terms and conditions of Paragraph 11 shall remain unmodified and continue to apply in full force and effect with respect to the Original Premises. 11. BROKERS. Landlord and Tenant each represents and warrants to the other that neither it nor its officers or agents nor anyone acting on its behalf has dealt with any real estate broker except the Broker(s) specified in the Basic Lease Information in the negotiating or making of this Amendment, and each party agrees to indemnify and hold harmless the other from any claim or claims, and costs and expenses, including attorneys' fees, incurred by the indemnified party in conjunction with any such claim or claims of any other broker or brokers to a commission in connection with this Amendment as a result of the actions of the indemnifying party. Landlord shall pay the brokerage commissions due to the Brokers listed in the Basic Lease Information. 12. BASIC LEASE INFORMATION. As of the Expansion Space Commencement Date, the Basic Lease Information in the Lease shall be amended and restated pursuant to the Basic Lease Information attached as Exhibit Z. 13. RATIFICATION. As amended hereby, the Lease is hereby ratified and confirmed in all respects. In the event of any inconsistencies between the terms of this Amendment and the Lease, the terms of this Amendment shall prevail. 14. SUCCESSORS AND ASSIGNS. This Amendment shall bind and inure to the benefit of Landlord and Tenant and their respective legal representatives and successors and assigns. SIGNATURES ON NEXT PAGE * CONFIDENTIAL TREATMENT REQUESTED 4. 5 IN WITNESS WHEREOF, Landlord and Tenant have executed this Amendment to Lease as of the date first above written. LANDLORD: HMS GATEWAY OFFICE, L.P., a Delaware limited liability company By: Hines Gateway Office, L.P., General Partner By: Hines Interests Limited Partnership, General Partner By: Hines Holdings, Inc., General Partner By: /s/ James Buie ------------------------------------- Name: James Buie ------------------------------------ Its: EVP ------------------------------------- TENANT: COULTER PHARMACEUTICAL, INC., a Delaware corporation By: /s/ William G. Harris ---------------------------------- Name: William G. Harris ---------------------------------- Its: Vice President and CFO ---------------------------------- 6 EXHIBIT A-FA BASE BUILDING CONSTRUCTION AGREEMENT This exhibit, entitled "Base Building Construction Agreement", is and shall constitute Exhibit A-FA to the First Amendment to Lease Agreement, dated as of November 10, 1998, by and between Landlord and Tenant (the "First Amendment"). The terms and conditions of this Exhibit A-FA are hereby incorporated into and are made a part of the First Amendment. As used in this Exhibit, the term "Lease" shall include the original Lease Agreement and the First Amendment. Subject to the terms and conditions set forth herein and in the Lease, Landlord shall cause construction of the Building in accordance with the procedures set forth below: (A) DEFINITIONS. (1) "BASE BUILDING IMPROVEMENTS" shall mean a [...***...] story building, containing approximately [...***...]* square feet, all exterior surfaces, utilities, landscaping and paved parking, all in substantial compliance with those items listed on the Preliminary Specifications as "Base Building" and located substantially in accordance with the Site Plan. (2) "BASE BUILDING PLANS AND SPECIFICATIONS" is defined in Section B. 1 below. (3) "BUILDING WORK COST" is defined in Section B.3 below. (4) "CONTRACTOR" shall mean Rudolph & Sletten. (5) "CONSTRUCTION WARRANTIES" is defined in Section D.2 below. (6) "LANDLORD'S ARCHITECT" shall mean DES Architects/Engineers or any replacement architect selected by Landlord in Landlord's reasonable discretion. (7) "LANDLORD'S CONTRACT" shall mean the construction contract entered into by and between Landlord and the Contractor for the construction of the Base Building Improvements and any Tenant Requested Base Building Improvements. (8) "PRELIMINARY SPECIFICATIONS" shall mean those preliminary specifications for construction of the Base Building Improvements categorized as "Base Building" and more particularly described on the attached Schedule A-1. (9) "650 GATEWAY PRELIMINARY SPECIFICATIONS" shall mean those preliminary specifications for construction of the Base Building Improvements categorized as "Base Building" and more particularly described on the attached Schedule A-1. (10) "SITE PLAN" shall mean the site plan set forth on the attached Schedule A-2 establishing the approximate location of the Building. All details relating to the Project * CONFIDENTIAL TREATMENT REQUESTED 7 contained on the Site Plan, including without limitation, location of the Building, parking areas, ingress, egress, direction of driveways, and entrances are from time to time subject to change in Landlord's discretion, upon written consent from Tenant, which consent shall not be unreasonably withheld, conditioned or delayed and provided further that if Tenant fails to respond within five (5) business days following Landlord's request for consent, Tenant shall be conclusively deemed to have given its approval to any such change. Notwithstanding the foregoing, Landlord may, without the written consent of Tenant, change any details relating to the Project as may be required by any governmental agency or as necessary to comply with any governmental requirements or to address structural or unanticipated field conditions or which, in the reasonable discretion of Landlord, will not have a material effect on Tenant's use of the Premises or a material effect on the aesthetic appearance or impression relating to the area covered by the Site Plan. (11) "TENANT'S COSTS" is defined in Section B.6 below. (12) "TENANT REQUESTED BASE BUILDING IMPROVEMENTS" shall mean those improvements requested by Tenant in accordance with this Exhibit A-FA that are to be incorporated into the Base Building Plans and Specifications. Capitalized terms not otherwise defined in this Exhibit A shall have the meanings ascribed to them in the Lease. (B) SCHEDULE. (1) PLANS AND SPECIFICATIONS. At Landlord's sole cost and expense, Landlord's Architect shall prepare, on or before November 15, 1998, plans and specifications (the "Base Building Plans and Specifications") for construction of the Base Building Improvements substantially in accordance with the 650 Gateway Preliminary Specifications. Tenant shall have the right to approve the Base Building Plans and Specifications only to the extent of any material deviations from the 650 Gateway Preliminary Specifications; provided, however, that such approval shall not be unreasonably withheld, conditioned, or delayed and, provided further that if Tenant fails to respond within [...***...]* business days following Landlord's request for approval, Tenant shall be conclusively deemed to have given its approval to the matter submitted by Landlord. Notwithstanding the foregoing, the Base Building Plans and Specifications are, from time to time, subject to change in Landlord's discretion, upon written consent from Tenant, which consent shall not be unreasonably withheld, conditioned or delayed and provided further that if Tenant fails to respond within [...***...] business days following Landlord's request for consent, Tenant shall be conclusively deemed to have given its consent to any such change. Landlord may without the written consent of the Tenant change the Base Building Plans and Specifications as may be required by any governmental agency or as necessary to comply with any governmental requirements or to address structural or unanticipated field conditions or which, in the reasonable discretion of Landlord, will not have a material effect on Tenant's use of the Premises or a material effect on the aesthetic appearance or impression relating to the Base Building Improvements. * CONFIDENTIAL TREATMENT REQUESTED 2. 8 (2) TENANT REQUESTED BASE BUILDING IMPROVEMENTS. On or before the date that is [...***...]* weeks after the date of this Lease, Tenant shall deliver to Landlord's Architect detailed specifications for any Tenant Requested Base Building Improvements. All Tenant Requested Base Building Improvements shall be subject to review and approval by Landlord, which approval may be given or withheld in Landlord's reasonable discretion, to ensure, among other things, that the Tenant Requested Base Building Improvements are compatible with all other construction and all electrical, mechanical, life safety, and other systems within the Building. If Landlord disapproves the Tenant Requested Base Building Improvements, then within five (5) business days thereafter, Landlord shall meet with the Tenant's Architect (as defined in Exhibit B-FA) and Tenant to discuss, or shall submit to Tenant's Architect and Tenant in writing, the reasons for Landlord's disapproval. Within five (5) business days following such meeting or submission, Tenant shall cause Tenant's Architect to revise the same and to submit new Tenant Requested Base Building Improvements to Landlord. The procedure set forth in this paragraph will be repeated as set forth above until Landlord has approved the Tenant Requested Base Building Improvements. (3) ESTIMATE OF BUILDING WORK COSTS. Promptly after approval of the Tenant Requested Base Building Improvements, Landlord shall furnish Tenant with an estimate of the cost of the Tenant Requested Base Building Improvements (the "Building Work Cost"). (4) TENANT'S REVIEW OF BUILDING WORK COSTS. The Building Work Cost shall be subject to Tenant's approval, which approval shall not be unreasonably withheld, conditioned or delayed and provided further that if Tenant fails to respond within five (5) business days following Landlord's request for consent, Tenant shall be conclusively deemed to have given its approval to the Building Work Costs. If Tenant timely disapproves the Building Work Cost, then within five (5) business days thereafter, Tenant shall meet with Landlord, Contractor, Landlord's Architect and Tenant's Architect to discuss value engineering changes to the Tenant Requested Base Building Improvements. Within five (5) business days following such meeting, Tenant shall cause Tenant's Architect to revise the Tenant Requested Base Building Improvements and to submit revised Tenant Requested Base Building Improvements for approval by Landlord in accordance with the procedure set forth above and for a new Building Work Cost to be prepared by Landlord. The procedure set forth in this paragraph will be repeated until Tenant has approved the Building Work Cost. (5) REVISION OF PLANS & SPECIFICATIONS. Following Landlord's approval of the Tenant Requested Base Building Improvements and Tenant's approval of the Building Work Cost, Landlord shall cause Landlord's Architect to revise the Base Building Plans and Specifications to incorporate the Tenant Requested Base Building Improvements within fifteen (15) days after receipt of Tenant's approval of the Building Work Cost. (6) TENANT'S RESPONSIBILITY FOR COST OF TENANT REQUESTED BASE BUILDING IMPROVEMENTS. All costs associated with incorporating the Tenant Requested Base Building Improvements into the Base Building Plans and Specifications and all costs of constructing (including without limitation the cost of obtaining all necessary city approvals and permits) the Tenant Requested Base Building Improvements (the "Tenant's Costs") shall be the responsibility * CONFIDENTIAL TREATMENT REQUESTED 3. 9 of Tenant and shall not be credited against Tenant's Allowance, as defined in Exhibit B-FA. Tenant shall make progress payments to Landlord from time to time as the Tenant Requested Base Building Improvements are constructed. Tenant shall pay the portion of such progress payments attributable to Tenant's Costs to Landlord within ten (10) days of delivery of statements from Landlord to Tenant therefor. Upon receipt of such payments, Landlord shall make all progress payments directly to Contractor or subcontractors, as appropriate. Landlord shall be entitled to suspend or terminate construction of the Base Building Improvements and to declare Tenant in default in accordance with the terms of the Lease, if payment by Tenant to Landlord of Tenant's Costs has not been received as required hereunder. (C) CONSTRUCTION. The Base Building Improvements shall be constructed, at Landlord's sole cost and expense, by Contractor in accordance with the Base Building Plans and Specifications, as the same may be amended or modified from time to time by Landlord and, if required, as approved by Tenant in accordance with this Exhibit A-FA. All changes to the Base Building Plans and Specifications requiring Tenant's approval must be evidenced by a written change order executed by Landlord and by Tenant or each of their agents, describing the change required in the Base Building Improvements and, the cost of such changes shall be paid in accordance with the terms of this Exhibit A-FA. (D) GENERAL. (1) RIGHT OF TERMINATION. Landlord and Tenant acknowledge that construction of the Base Building Improvements and all matters relating thereto are subject to Landlord obtaining all necessary governmental and private approvals to commence construction of the Base Building Improvements. Landlord shall use commercially reasonable efforts to obtain such approvals; however, if Landlord is unable to obtain such approvals by [...***...], either party shall have the right to terminate' this Lease, as to the Expansion Space only, by delivering written notice of termination to the other party on or before [...***...]. The Lease as to the Original Premises shall remain in full force and effect and shall be unmodified by any termination pursuant hereto. If no such notice of termination is given, the Lease shall remain in full force and effect as to the Original Premises and the Expansion Space. Notwithstanding anything herein to the contrary, Landlord shall not be liable to Tenant for any loss or damage resulting from any delay in constructing or developing the Base Building Improvements, nor shall such failure affect the obligations of Tenant under the Lease, except as otherwise set forth in the Lease. (2) CONSTRUCTION WARRANTIES. Landlord shall obtain from Contractor, and shall request Contractor to obtain from all subcontractors and material suppliers, warranties (collectively, "Construction Warranties") for all components of the Base Building Improvements for which warranties are customarily provided in the construction industry and Landlord shall enforce the Construction Warranties as reasonably requested by Tenant. (3) LANDLORD'S COVENANTS. Subject to the terms and conditions of the Lease, Landlord covenants that (a) the Base Building Improvements shall be constructed in compliance with all applicable building code requirements in effect and being actively enforced by the City 4. 10 of South San Francisco on the date the applicable building permits for construction of the Base Building Improvements were issued to Contractor and substantially in accordance with the Base Building Plans and Specifications and (b) that the Base Building Improvements shall be free from material latent defects in design, materials and workmanship; provided however, Landlord shall have no liability under this paragraph unless failure to comply with the terms hereof materially adversely affect Tenant's use of the Premises. Any claims by Tenant under clause (a) above, shall be made in writing not later than one (1) year after the Expansion Commencement Date and any claims by Tenant under clause (b) above, shall be made in writing not later than the earlier of [...***...]* years after the Expansion Commencement Date or termination of the Lease. In the event Tenant fails to deliver a written claim to Landlord on or before such dates, then Landlord shall be conclusively deemed to have satisfied its obligations under this paragraph. The covenants contained in this paragraph are subject to Paragraph 39 of the Lease and are made specifically and exclusively for the benefit of the original Tenant. INITIALS: TENANT: /s/ --------------------------------- LANDLORD: /s/ ------------------------------- * CONFIDENTIAL TREATMENT REQUESTED 5. 11 COULTER PHARMACEUTICAL - SCHEDULE A1 PRELIMINARY SPECIFICATIONS COST RESPONSIBILITY
Base Description Building Tenant - --------------------------------------------------------------------------- ---------- ----------- Sitework - All necessary fees and permits for Base Building Works. [...***...] [...***...] - All grading of the site to predetermined grades per DES [...***...] [...***...] Architects plans. - Installation of all necessary underground utilities, storm drain, [...***...] [...***...] sewer, catch basins, drain inlets, common trench, water, electricity, cable televisions and gas meter per DES Architects documents. - Installation of all offsite and onsite curbs, gutters and [...***...] [...***...] sidewalks as shown on Des Architect construction documents. - Installation of all irrigation and landscaping per DES [...***...] [...***...] Architect's plans. o All area drains in landscaping areas, which shall be connected to [...***...] [...***...] the storm drain system if required by DES Architect - Installation of separate water and electrical meters for all [...***...] [...***...] common area landscaping - Installation of code required informational and directional [...***...] [...***...] signage. - Illuminated and non-illuminated interior signage by tenant. [...***...] - Illuminated monument signage and on building identification [...***...] [...***...] signage as reviewed by Tenant. - Striping of all parking areas per DES Architects documents. [...***...] [...***...] - Installation of all trash screens as required by Planning [...***...] [...***...] Department of the City of South San Francisco - Installation of all exterior lighting with a minimum coverage in [...***...] [...***...] both parking areas and walkways of not less than one foot candle. Structure - All necessary fees and permits for Base Building work. [...***...] [...***...] - All work necessary per code to make the Base Building handicap [...***...] [...***...] accessible. - Minimum 5" slab on grade in conformance with specifications and [...***...] [...***...] recommendations of Base Building geotechnical and engineering consultants. Finish shall be smooth. - Sand fill and moisture barrier under slab on grade as recommended [...***...] [...***...] by DES Architects. - Exterior concrete walls shall be sandblasted and sealed. [...***...] [...***...] - All structural steel shall be erected per DES Architect's [...***...] [...***...] specifications. - All structural steel shall not be fireproofed unless required by [...***...] [...***...] local codes. - Second floor decking shall be galvanized metal with a lightweight [...***...] [...***...] concrete topping slab. Finish shall be smooth. - All exterior vision glass shall be 1/4" thick with reflective [...***...] [...***...] coating. - Roof membrane shall be 4-ply built-up system with a mineral fiber [...***...] [...***...] cap sheet. - All required condensate lines to be installed and terminated at [...***...] [...***...] the nearest roof drain for Base Building equipment. - Roof drains per plan with drain lines tying into the storm drain [...***...] [...***...] system. Scuppers for overflow to be provided if required by code. - Convenience outlets, as required by code, on the roof. [...***...] [...***...] - Floor systems shall be designed to a minimum of 45 lbs. Per [...***...] [...***...] square foot for office space and a minimum of 100 lbs. Per square foot on ground floor for lab space.
* CONFIDENTIAL TREATMENT REQUESTED 12 COULTER PHARMACEUTICAL - SCHEDULE A1 PRELIMINARY SPECIFICATIONS COST RESPONSIBILITY - Roof insulation to meet minimum energy code. [...***...] [...***...] - Roof live load to accommodate 50 lb. dead load and necessary [...***...] [...***...] reinforcement for additional lab related mechanical equipment in areas indicated on plan. - Required second floor penetrations, including blockouts, as shown [...***...] [...***...] on Tenant Improvement drawings for mechanical, electrical and plumbing trades and roof hatch. - Required roof penetrations, including blockouts, as shown on base [...***...] [...***...] building for mechanical, electrical and plumbing work. - Top of slab on grade to top of second floor slab shall be [...***...] [...***...] 15'-0". Top of second floor slab to top of roof trusses shall be 13'-0". - All exterior doors, except entrance doors, shall be hollow core [...***...] [...***...] metal with metal jambs as shown in schematic documents with hardware as required by Tenant. - One 12'-0" x 12'-0" steel rollup door shall be installed per [...***...] [...***...] Tenant specifications for delivery area. - Front entry doors shall be a pair of 3'-0" x 8'-0" fully [...***...] [...***...] supported, balanced aluminum and glass doors with hardware approved as required by Tenant. - All interior stairs as required by code, but not less than two [...***...] [...***...] per building. All stairs shall be metal pan stairs with concrete fill. - Stair carpeting, if required, to be provided tenant. [...***...] [...***...] - All interior stair handrails shall be primed. Proper backing [...***...] [...***...] shall be installed. - All stairwells shall be sheetrocked, taped and ready for paint. [...***...] [...***...] - All stairwells shall include code required lighting. [...***...] [...***...] - All required base building life safety signage as required by [...***...] [...***...] code. - All equipment platforms shall have a sheetmetal cap and minimum [...***...] [...***...] 3" apron around the perimeter. Six bay equipment platform as indicated on plan ready to receive framing for equipment. - One hydraulic passenger elevator, including all necessary wiring [...***...] [...***...] and equipment, with a capacity of not less than 2,500 lbs. and minimum speed of 100' per minute. - A complete elevator cab that is the manufacturer's standard. [...***...] [...***...] - Base Building to accommodate a 9'-0" finished ceiling height on [...***...] [...***...] both floors. - All exterior concrete walls shall be finished on the interior [...***...] [...***...] with lightweight metal studs, insulation and sheetrock, taped with a smooth finish. - Master keyed exterior locks. [...***...] [...***...] - Individual keying per tenant specifications. [...***...] [...***...] - A complete fire sprinkler system, sized to meet code per the [...***...] [...***...] interior improvement design. This system shall be complete and operational including required drops to the suspended ceiling in tenant finished areas. The system shall include, but is not limited to, valves, dry stand pipes, monitoring stations, aennciators, horns and storage tanks, if required by code. - Roof access ladder and hatch in one stairwell. [...***...] [...***...] - Patio furniture [...***...] [...***...] UTILITIES AND BACKBONE SYSTEMS [...***...] [...***...] - 2,000 amp. 277/480 volt, 3 phase electrical service switchgear [...***...] [...***...] and meter and switch center room. - Separate electrical meter, panel and time clock for Parking lot [...***...] [...***...] lighting and irrigation. - Telephone trunk lines to the interior telephone room sufficient [...***...] [...***...] in size to accommodate the buildings.
* CONFIDENTIAL TREATMENT REQUESTED 2. 13 COULTER PHARMACEUTICAL - SCHEDULE A1 PRELIMINARY SPECIFICATIONS COST RESPONSIBILITY - Two PVC conduits, minimum of 4" between the first and option [...***...] [...***...] buildings for telephone and data. - Required water service for sprinkler system. [...***...] [...***...] - A minimum of 2" domestic water service to building. There shall [...***...] [...***...] be a separate meter for this water line and it shall terminate inside the building below the second floor. - A minimum 4" natural gas service building. There shall be a [...***...] [...***...] separate meter for this service and it shall terminate inside the building below the second floor. - As required, a 6" cast iron, sanitary sewer gut line the entire [...***...] [...***...] length of the building. This gut line shall have, at a minimum, one cleanout at the end of its run, one in the restroom core and one cleanout at the entrance to the building. Exact location of this gut line shall be determined by tenant. - All necessary electrical and fire sprinkler rooms, sized to [...***...] [...***...] accommodate Tenant requirements, shall be completed with light weight metal studs, metal doors and jambs, required ventilation through the roof membrane, lighting, convenience outlets and sheetrock, taped and textured. MEP - All required electrical to base building equipment. [...***...] [...***...] - All backboards as required by Tenant. [...***...] [...***...] - All required electrical outlets and lighting to complete base [...***...] [...***...] building requirements. - Smoke detectors as required by code for Base Building [...***...] [...***...] - All required roof walk pads, conduit supports, and penetrations [...***...] [...***...] for Base Building equipment. - All sheetmetal necessary to provide moisture protection and [...***...] [...***...] flashing details for Base Building equipment. (None anticipated) - All necessary seismic restraints on Base Building equipment. [...***...] [...***...] (None anticipated) - A centrally located, gas hot water heater large enough to [...***...] [...***...] accommodate all of the tenant requirements including hot water to all labs. - A mechanical chiller system, sized to accommodate [...***...] [...***...] [...***...] square feet of office space. - All ductwork and penetrations necessary to provide both supply [...***...] [...***...] and return air to each floor, elevator cores and lobby restrooms shall be provided. All necessary fire and smoke dampers shall be included for Base Building work. Restrooms, elevator cores, lobby and stairwells shall be complete. - All ductwork and roof mounted fans necessary to provide proper [...***...] [...***...] ventilation in the restrooms, electrical closets and elevator machine room. - Screening of roof mounted equipment. Roof screen as shown on [...***...] [...***...] roof plan. - Exhaust ducts, through the roof, for lab ventilating as specified [...***...] [...***...] by Tenant. - Hose bib near delivery areas. [...***...] [...***...] LOBBY AREA - Architect design fees associated with the lobby area. [...***...] [...***...] - [...***...] story height with skylight, visibility to stairwell [...***...] [...***...] and a catwalk and overlook at the second floor level. - Area of Lobby to be 30' x 30'. Landlord to contribute [...***...] [...***...] [...***...] - All walls sheetrocked, taped with a smooth finish. If Tenant so [...***...] [...***...] desires, all walls will be prepared and ready to accept wallcovering. - Electrical outlets, telephone outlets and data outlets necessary [...***...] [...***...] to accommodate the
* CONFIDENTIAL TREATMENT REQUESTED 3. 14 COULTER PHARMACEUTICAL - SCHEDULE A1 PRELIMINARY SPECIFICATIONS COST RESPONSIBILITY Tenant's proposed lobby layout. - Ceramic tile entry, 8'-0" wide, from the front doors to the [...***...] [...***...] reception counter. All other areas to be carpet, a 36 oz. loop minimum, and if desired by Tenant, with a border. - 6" or 2" rubber base in all areas. [...***...] [...***...] - Entry doors to be a pair of aluminum glass with hardware reviewed [...***...] [...***...] by Tenant. - All doors off of lobby to be wood grain, 3'-0" x 8'-0" minimum in [...***...] [...***...] height. Hardware to be selected by tenant. - All HVAC to be complete. [...***...] [...***...] - All Base Building areas to be handicap accessible per code. [...***...] [...***...] - All finishes by Tenant. [...***...] [...***...] - Ceiling to be sheetrock, taped and textured. [...***...] [...***...] - Lighting to include, but not be limited to, down lights, recessed [...***...] [...***...] wall washers, recessed parabolic or halogen. - Wallcovering on all walls if so desired by Tenant. [...***...] [...***...] - Fully painted to Tenant specifications. [...***...] [...***...] ELEVATOR LOBBIES - Sheetrock walls and ceiling, taped with a smooth finish. [...***...] [...***...] - Ceiling to have a multiple coffer with lighting behind. [...***...] [...***...] - Electrical outlets to support work required in the area. [...***...] [...***...] - Stainless steel jambs and head around elevator opening ground [...***...] [...***...] floor. - Painted hollow metal jambs and head on 2nd floor. [...***...] [...***...] - Nickel/silver threshold and elevator entrance. [...***...] [...***...] - Grout under elevator thresholds. [...***...] [...***...] - Carpet, 36 oz. loop minimum, and if desired by Tenant, with a [...***...] [...***...] border. - 6" and 2" rubber base at all areas. [...***...] [...***...] - Magnetic hold opens on all lobby doors if required by code. [...***...] [...***...] - Lobby door to be wood grain, full height, with hardware reviewed [...***...] [...***...] by Tenant. - Lighting to include recessed down lights, recessed lights or wall [...***...] [...***...] washers. - Fully painted to Tenant specifications. [...***...] [...***...] - All HVAC to be complete. [...***...] [...***...] - All elevator lobby areas to have a one hour rating if required by [...***...] [...***...] code. RESTROOMS - Sheetrock walls taped with a smooth finish. A cofer shall be [...***...] [...***...] installed over the vanity area. - Ceiling to be drywall. [...***...] [...***...] - Ceramic tile floors and wainscot on wet wall. [...***...] [...***...] - All floors sloped to a floor drain. [...***...] [...***...] - Light cove with egg crate louver over stalls and urinals. [...***...] [...***...] - Provide janitor closets on each floor adjacent to restrooms. [...***...] [...***...] - Provide sinks in janitor closets. [...***...] [...***...] - Recessed lighting at entry, sinks and outside stalls. [...***...] [...***...] - All partitions to be meal and hung from wall. [...***...] [...***...] - All toilets and urinals to be hung from wall. [...***...] [...***...] - Plastic laminate counter tops over moisture resistant plywood [...***...] [...***...] with 5' lipped apron
* CONFIDENTIAL TREATMENT REQUESTED 4. 15 COULTER PHARMACEUTICAL - SCHEDULE A1 PRELIMINARY SPECIFICATIONS COST RESPONSIBILITY and 6" splash (to be ADA compliant). - Full length mirror with polished stainless steel frame. [...***...] [...***...] - Provide insulation for hot and cold water pipes. [...***...] [...***...] - Minimum toilet accessories to include, but not limited to, sinks, [...***...] [...***...] stainless faucets, toilets, urinals, recessed paper towel dispensers with integral waste, counter mounted soap dispensers, sanitary napkin dispenser, seat cover dispenser, toilet tissue dispenser, handicap grab bars and partition mounted coat hooks. - Paint above wainscot as directed by Tenant. [...***...] [...***...] - Vestibules and finishes. [...***...] [...***...]
* CONFIDENTIAL TREATMENT REQUESTED 5. 16 SCHEDULE A-2 SITE PLAN [GRAPHIC - MAP OF SITE] 1. 17 EXHIBIT B-FA PREMISES CONSTRUCTION AGREEMENT This exhibit, entitled "Premises Construction Agreement", is and shall constitute Exhibit B-FA to the First Amendment to Lease Agreement, dated as of November 10, 1998, by and between Landlord and Tenant (the "First Amendment"). The terms and conditions of this Exhibit B-FA are hereby incorporated into and are made a part of the First Amendment. As used in this exhibit, the term "Lease" shall include the original Lease Agreement and the First Amendment. Subject to the terms and conditions set forth herein and in the Lease, Landlord shall allow the construction or installation of the improvements in the interior of the Premises in accordance with the procedures set forth below: (A) DEFINITIONS. (1) "APPROVED PLANS" is defined in Section B.6 below. (2) "CONTRACTOR" shall mean Rudolph and Sletten. (3) "ESTIMATED WORK COST" is defined in Section B.3 below. (4) "EXCESS TENANT IMPROVEMENTS" is defined in Section B.7 below. (5) "FINAL COST QUOTATION" is defined in Section B.7 below and shall include all costs associated with the Tenant Improvements, including without limitation, costs of all tenant improvement work; architectural and engineering fees; governmental agency fees for permits, licenses and inspections; construction fees, including, without limitation, general contractors' overhead and supervision fees; Landlord's administration fee of [...***...]; and such other costs as may be reasonably incurred by Landlord in connection with such construction. (6) "PRELIMINARY PLANS" is defined in Section B. 1 below. (7) "TENANT'S ALLOWANCE" shall mean an amount equal to [...***...], which amount shall, except as otherwise provided in this Exhibit B-FA, be paid by Landlord toward the cost of completion of the Tenant Improvements and related design, engineering, governmental, overhead, supervision and administration fees and costs (collectively, the "Tenant Improvement Cost"). Notwithstanding the foregoing, no portion of the Tenant's Allowance shall be paid by Landlord toward the cost of the Tenant Requested Base Building Improvements, or Tenant Improvements that constitute furniture, equipment or trade fixtures or result in changes to the Base Building Improvements. If the Tenant Improvement Cost exceeds the Tenant's Allowance, the difference shall be paid by Tenant in accordance with this Exhibit B-FA. * CONFIDENTIAL TREATMENT REQUESTED 1. 18 (8) "TENANT'S ARCHITECT" shall mean CAS Architects, or such other licensed architect designated by Tenant and subject to Landlord's prior approval, which approval shall be given or withheld in Landlord's reasonable discretion. (9) "TENANT'S CONTRACT" shall mean the construction contract entered into by and between the Tenant and the Contractor for the construction of the Tenant Improvements. (10) "TENANT IMPROVEMENTS" shall mean all improvements made to the Premises pursuant to the Approved Plans. Capitalized terms not otherwise defined in this Exhibit B-FA shall have the meanings ascribed to them in the Lease. (B) SCHEDULE. (1) Tenant shall cause Tenant's Architect to furnish to Landlord on or before [...***...], preliminary space plans and specifications (the "Preliminary Plans"). Tenant shall be responsible for all costs associated with the Preliminary Plans (collectively, the "Preliminary Design Costs"), including any revisions required by Section B.2 hereunder; provided, however, Tenant shall be reimbursed by Landlord out of the Tenant's Allowance for the Preliminary Design Costs reasonably incurred upon delivery to Landlord of invoices, receipts and other documents reasonably required to substantiate such costs. (2) The Preliminary Plans shall be subject to Landlord's approval, which approval shall not be unreasonably withheld, conditioned or delayed. If Landlord disapproves the Preliminary Plans, then within five (5) business days thereafter, Landlord shall meet with the Tenant's Architect and Tenant to discuss, or shall submit to the Tenant's Architect and Tenant in writing, the reasons for Landlord's disapproval. Within five (5) business days following such meeting or submission, Tenant shall cause the Tenant's Architect to revise the same and to submit new Preliminary Plans to Landlord. The same procedure set forth in this paragraph will be repeated as set forth above until Landlord has approved the Preliminary Plans. (3) Promptly after approval of the Preliminary Plans, Tenant shall cause Contractor to furnish Landlord with an estimate of the cost of the Tenant Improvements as shown on the Preliminary Plans and Landlord shall in turn provide Tenant with an estimate of the cost of the Tenant Improvements, including, without limitation, estimates of the following costs: architectural and engineering fees, governmental agency fees for permits, licenses and inspections, overhead and supervision fees, and Landlord's administrative fees (the "Estimated Work Cost"). The Estimated Work Cost shall separately itemize the cost of changes to the Base Building Improvements for those Tenant Improvements that will necessitate changes in the Base Building Improvements. (4) The Estimated Work Cost shall be subject to Tenant's approval, which approval shall not be unreasonably withheld, conditioned or delayed and provided further that if Tenant fails to respond within five (5) business days following Landlord's delivery of the Estimated Work Cost, Tenant shall be conclusively deemed to have given its approval of the * CONFIDENTIAL TREATMENT REQUESTED 2. 19 Estimated Work Cost. If Tenant timely disapproves the Estimated Work Cost, then within five-(5) business days thereafter, Tenant shall meet with Landlord, Contractor and Tenant's Architect to discuss value engineering changes to the Preliminary Plans. Within five (5) business days following such meeting, Tenant shall cause Tenant's Architect to revise the Preliminary Plans and to submit new Preliminary Plans for approval by Landlord in accordance with the procedure set forth above and for a new Estimated Work Cost to be prepared by Landlord. The procedure set forth in this paragraph will be repeated until Tenant has approved the Estimated Work Cost. (5) Following Landlord's approval of the Preliminary Plans and Tenant's approval of the Estimated Work Cost, Tenant shall cause Tenant's Architect to prepare detailed construction drawings and specifications (the "Working Drawings") for the Tenant Improvements based strictly upon the Preliminary Plans, except as otherwise agreed in writing by Landlord and Tenant. The Working Drawings shall be completed within [...***...] business days after approval of the Preliminary Plans and Estimated Work Cost, but in no event later than [...***...]. (6) The Working Drawings shall be subject to Landlord's approval, which approval shall not be unreasonably withheld, conditioned or delayed. If Landlord disapproves the Working Drawings, then within five (5) business days thereafter, Landlord shall meet with Tenant's Architect and Tenant to discuss, or shall submit to the Tenant's Architect and Tenant in writing, the reasons for Landlord's disapproval. Within five (5) business days following such meeting or submission, Tenant shall cause Tenant's Architect to revise the same and to submit new Working Drawings to Landlord, and the same procedure will be repeated as set forth above until Landlord has approved the Working Drawings (the "Approved Plans"). The reasonable costs of preparing the Working Drawings, together with any revisions thereto, may be paid by Landlord to Tenant from Tenant's Allowance. Upon approval of the Working Drawings, Landlord shall deliver to Tenant a list of Tenant Improvements to be removed by Tenant, at Tenant's cost and expense in accordance with Paragraph 11 of the Lease, upon expiration of the Term or earlier termination of the Lease. Notwithstanding the foregoing, during the preparation of the Working Drawings, Landlord shall, upon Tenant's request, advise Tenant of items that will be required to be removed pursuant to the previous sentence. (7) Within ten (10) business days after Landlord's approval of the Approved Plans, Tenant shall cause Contractor to furnish to Landlord a cost estimate for the Tenant Improvements based upon the Approved Plans and Landlord shall in turn provide Tenant with a final cost quotation for the Tenant Improvements (the "Final Cost Quotation"). If the Final Cost Quotation is greater than the Tenant's Allowance, Tenant shall be responsible for the difference between the Tenant's Allowance and the Final Cost Quotation (the "Excess Tenant Improvements Cost"). (8) Landlord and Tenant shall make progress payments on a pro rata basis (in the proportion that the Tenant's Allowance paid by Landlord and the Excess Tenant Improvements Cost paid by Tenant bear to the Final Cost Quotation) from time to time as the Tenant Improvements are constructed in the Premises. Tenant shall pay its pro rata share of any progress payments directly to Contractor or subcontractors, as appropriate, and Landlord shall * CONFIDENTIAL TREATMENT REQUESTED 3. 20 pay its pro rata share of any progress payments directly to Contractor or subcontractors, as appropriate. Landlord shall be entitled to suspend or terminate construction of the Tenant Improvements and to declare Tenant in default in accordance with the terms of the Lease, if payment by Tenant of Tenant's pro rata share of any progress payment has not been received by Contractor when due, as required hereunder. Moreover, Landlord shall not be required to pay its pro rata share of any progress payment until such time as Landlord receives from Contractor an unconditional lien waiver as to each progress payment and a conditional lien waiver for the next due progress payment. All lien waivers shall comply with California law regarding materialmen and mechanic's liens. Notwithstanding the foregoing, Tenant may, at Tenant's option and upon reasonable prior written notice to Landlord, pay the full amount of the progress payment and, subject to Landlord's receipt of the lien waivers specified above, obtain reimbursement from Landlord for Landlord's pro rata share promptly after Tenant's delivery to Landlord of a written demand for such pro rata share owing. (C) TENANT IMPROVEMENT CONSTRUCTION. (1) All Tenant Improvements to be constructed or installed in the Premises shall be performed by Contractor in accordance with the Approved Plans, subject to any changes agreed to by Landlord and Tenant in writing. Landlord shall have no obligation to Tenant for defects in design, workmanship or materials in connection with the Tenant Improvements. Any changes to the Approved Plans shall require the written approval of Landlord and Tenant, which approval shall not be unreasonably withheld, conditioned or delayed. All such changes must be evidenced by a written change order executed by Landlord and Tenant or their agent describing the change required in the Approved Plans, and the cost of such changes shall be paid in accordance with the terms of this Exhibit B-FA. (2) Landlord shall coordinate construction of the Tenant Improvements by Contractor with the construction of the Base Building Improvements by Contractor in the most efficient manner reasonably possible for the timely completion of the Base Building Improvements and the Tenant Improvements. Landlord and Tenant shall each use good faith efforts to reasonably resolve any issues or conflicts that may arise during the course of constructing the Tenant Improvements and the Base Building Improvements. Entry by Contractor in accordance with this Exhibit B-FA shall not constitute Tenant's occupancy of the Expansion Space under Paragraph 3 of the Lease; however, all terms and conditions of the Lease shall apply to Contractor's occupancy of and work within the Expansion Space. (3) In addition to and without limitation on the requirements set forth in the Lease, Tenant shall ensure that, with respect to the work to be performed as part of Tenant's Contract, Contractor and all subcontractor(s) procure and maintain in full force and effect during the course of construction a "broad form" commercial general liability and property damage policy of insurance naming, Landlord, Tenant and Landlord's lenders as additional insureds. The minimum limit of coverage of the aforesaid policy shall be in the amount of not less that [...***...] for injury or death of one person in any one accident or occurrence and in the amount of not less than [...***...] for injury or death of more than one person in any one accident or occurrence, and shall contain a severability of interest clause or a cross liability endorsement. * CONFIDENTIAL TREATMENT REQUESTED 4. 21 Such insurance shall further insure Landlord and Tenant against liability for property damage of at least [...***...]. (D) TERM COMMENCEMENT. (1) Notwithstanding anything in the Lease to the contrary, except as otherwise provided in D.2 and D.3 below, the commencement date as to the Expansion Space (the "Expansion Space Commencement Date") shall be no later than [...***...]. The Expansion Space Commencement Date shall not be adjusted due to delays caused by Tenant or any employee, agent or representative of Tenant ("Tenant Delays"), including, without limitation, delays caused by (i) failure to furnish information in accordance with this Exhibit B-FA or Exhibit A-FA of the Lease; (ii) Tenant's request for any special, long lead time materials or installations as part of the Tenant Improvements or the Tenant Requested Base Building Improvements; (iii) Tenant's changes in the Approved Plans; (iv) any changes initiated by reason of the disapproval of any plans or drawings or any cost proposals or authorizations resulting in the preparation of revised plans, drawings, cost proposals or authorizations beyond the second submission to Landlord for approval; (v) field changes to construction work; (vi) the delivery, installation or completion of the Tenant Improvements work performed by; (vii)Tenant's request for any Tenant Requested Base Building Improvements, as defined in Exhibit A-FA of the Lease or any delay in delivering the Tenant Requested Base Building Improvements beyond the date set forth in Section B.2 of Exhibit A-FA; or (viii) any other act or omission of Tenant. (2) Except as may be otherwise specifically provided herein or in the Lease, time periods for either party's performance under any provisions of this Exhibit B-FA, shall be extended for periods of time during which such party is prevented due to circumstances beyond such party's control, including, without limitation, strikes, embargoes, governmental regulations, delays in obtaining permits or materials, acts of God, war, civil commotion or other strife ("Force Majeure Events"). Each party shall use reasonable efforts to mitigate the effect of any Force Majeure Event upon such party's performance hereunder. In addition, if Landlord's Architect fails to complete the Base Building Plans and Specifications on or before the date set forth in Section B.1 of Exhibit A-FA of the First Amendment for reasons other than Tenant Delays, then the Expansion Space Commencement Date shall be delayed by one (1) day for each day of delay in the completion of the Base Building Plans and Specifications. (3) Intentionally deleted. (4) If, for any reason Landlord cannot perform any other covenant contained in this Exhibit B-FA or in the Lease related to the work described in this Exhibit B-FA, the Lease shall not be void or voidable nor shall Landlord be liable to Tenant for any loss or damage resulting therefrom, nor shall such failure affect the obligations of Tenant under the Lease or this Exhibit B-FA, except as otherwise specifically provided in the First Amendment. (E) GENERAL. (1) All drawings, space plans, plans and specifications for any improvements or installations in the Premises are expressly subject to Landlord's prior written approval, which * CONFIDENTIAL TREATMENT REQUESTED 5. 22 approval shall not be unreasonably withheld, conditioned or delayed. Any approval by Landlord of any drawings, plans or specifications prepared on behalf of Tenant including, without limitation, any Preliminary Plans, Working Drawings or Approved Plans, or any revisions thereto, shall not in any way bind Landlord, create any responsibility or liability on the part of the Landlord for the completeness of the same, their design sufficiency or compliance with applicable statutes, ordinances or regulations or constitute a representation or warranty by Landlord as to the adequacy or sufficiency of such drawings, plans or specifications, or the improvements to which they relate, but such approval shall merely evidence the consent of Landlord to such drawings, plans or specifications. (2) Any failure by Tenant to pay any amounts due hereunder shall have the same effect under the Lease as a failure to pay Rent and any failure by Tenant to perform any of its other obligations hereunder shall be subject to Paragraph 24 of the Lease. INITIALS: ----------------------------- TENANT: /s/ ------------------------------- LANDLORD /s/ ------------------------------ 6. 23 EXHIBIT H-FA EXPANSION SPACE WINDOW DATES
CONDITION INITIAL WINDOW DATE - --------- ------------------- Certificate from Landlord's Architect that the foundation of the [...***...] Building has been completed. Certificate from Landlord's Architect that the construction of [...***...] the Building has progressed to a "Water Tight Shell" Temporary Certificate of Occupancy [...***...]
INITIALS: ----------------------------- TENANT: /s/ ------------------------------- LANDLORD /s/ ------------------------------ * CONFIDENTIAL TREATMENT REQUESTED 1. 24 EXHIBIT Z BASIC LEASE INFORMATION Lease Date: November 7, 1997; amended by First Amendment dated November 10, 1998 Landlord: HMS Gateway Office, L.P. a Delaware limited partnership Landlord's Address: c/o Hines Interests Limited Partnership 101 California Street, Suite 1000 San Francisco, California 94111-5848 Attn: Tom Kruggel All notices sent to Landlord under this Lease shall be sent to the above address, with copies to: Hines Interests Limited Partnership 101 California Street, Suite 1000 San Francisco, California 94111-5848 Attn: Paul Paradis Tenant: Coulter Pharmaceutical, Inc., a Delaware corporation Tenant's Contact Person: William G. Harris Tenant's Address and Telephone Number prior to 550 California Avenue the Commencement Date: Suite 200 Palo Alto, California 94306-1440 (650) 842-7300 Tenant's Address and Telephone Number after the 600 Gateway Boulevard Commencement Date: South San Francisco, California 94080 (650) ___-__________ Premises Square Footage [...***...] square feet, subject to final determination by Landlord's Architect upon Commencement of the Term. Such measurement to be made in accordance with Landlord's Architect's standard measurement procedures or research and development space. Premises Address: 600 and 650 Gateway Boulevard South San Francisco, California Project: Approximately 7.85 acres of land commonly known as Lot 2B of the Gateway Center and referred to as the Gateway Technology Center, together with the land and improvements on which the Project is situated and all Common Areas.
* CONFIDENTIAL TREATMENT REQUESTED 1. 25 Building (if not the same as the Project): 600 Gateway Boulevard South San Francisco, California Tenant's Proportionate Share of Project: [...***...] subject to adjustment in accordance with Paragraph 4(c)(3) Tenant's Proportionate Share of Building: 100% Length of Term: [...***...] Estimated Commencement Date: November 14, 1998 for the Original Premises; September 1, 1999 for the Expansion Space Estimated Expiration Date: [...***...] Monthly Base Rent (Original Premises): [...***...] The above Monthly Base Rent calculations are subject to change after final determination of the Premises Square Footage and any such adjustment shall be based on a Monthly Base Rent for the first Lease year of [...***...] per square foot multiplied by the Premises Square Footage, and each subsequent Lease Year being [...***...] of the preceding Lease Year's Monthly Base Rent. Monthly Base Rent (Expansion Space): Monthly Base Rent for the Expansion Space shall, as of the Expansion Space Commencement Date, be an amount [...***...] the applicable rate per square foot being charged from time to time under the Lease for the Original Premises multiplied by the square footage of the Expansion Space. The rate per square foot being charged under the Lease for the Original Premises shall be determined by dividing the Monthly Base Rent due for the Original Premises by the Premises Square Footage for the Original Premises. Prepaid Rent: None Prepaid Additional Rent: None Security Deposit: [...***...] Permitted Use: General office and research and development activities associated with biotechnology/pharmaceutical services. All uses must be in accordance with zoning ordinances of the City of South San Francisco. Unreserved Parking Spaces: [...***...] non-exclusive and undesignated parking spaces.
* CONFIDENTIAL TREATMENT REQUESTED 2. 26 Broker(s): CB Commercial Real Estate Group, Inc. CB Madison Advisory Group Tenant's Allowance: [...***...] with respect to the Original Premises [...***...] with respect to the Expansion Space
* CONFIDENTIAL TREATMENT REQUESTED 3.
EX-10.28 9 AMEND #1 TO COLLABORATION AGREEMENT W/SMITHKLINE 1 Exhibit 10.28 ***Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4), 200.83 and 240.24b-2 SMITHKLINE BEECHAM VIA FACSIMILE HARD COPY TO FOLLOW BY OVERNIGHT EXPRESS MAIL November 30, 1998 Coulter Pharmaceutical, Inc. 550 California Avenue, Suite 200 Palo Alto, California 94306, USA Attention: Chief Financial Officer RE: Amendment # 1 to October 23, 1998 Collaboration Agreement Coulter Pharmaceutical, Inc. - SmithKline Beecham Corporation Dear Sir: This letter will confirm that the Collaboration Agreement (the "Agreement"), executed as of October 23, 1998 by and between Coulter Pharmaceutical, Inc., a company incorporated under the laws of the State of Delaware, with its principal place of business at 550 California Avenue, Suite 200, Palo Alto, California 94306, USA ("Coulter"), and SmithKline Beecham Corporation, a company incorporated under the laws of the Commonwealth of Pennsylvania, with its principal place of business at One Franklin Plaza, Philadelphia, Pennsylvania 19101, USA ("SB"), shall be amended as follows: - In Paragraph 19.1.3, all occurrences of the date [***] shall be changed to [***]. - All other terms and conditions of the Agreement shall remain in full force and effect. Please indicate your acceptance of this Amendment Agreement by signing and dating the duplicate copies of this letter below and returning on such fully executed copy to SB. Very truly yours, SMITHKLINE BEECHAM CORPORATION By: /s/ Donald G. Parman --------------------------------- Title: Secretary AGREED TO AND ACCEPTED: COULTER PHARMACEUTICAL, INC. By: /s/ Michael F. Bigham - --------------------------------- Title: President& CEO - --------------------------------- Date: 11-30-98 - --------------------------------- One Franklin Plaza, PO Box 7929, Philadelphia, PA 19101. Telephone(215) 751 4000. Fax(215) 751 3400. * Confidential Treatment Requested 2 cc (w/enclosure): Coulter Pharmaceutical, Inc. 550 California Avenue, Suite 200 Palo Alto, California 94306 USA Facsimile: (650) 849-7574 Attn: Chief Executive Officer and Coulter Pharmaceutical, Inc. 550 California Avenue, Suite 200 Palo Alto, California 94306 USA Facsimile: (650) 849-7574 Attn: Vice President, Business Development EX-10.29 10 LOAN & SECURITY AGRREMENT W/ SILICON VALLEY BANK 1 Exhibit 10.29 ***Text Omitted and Filed Separately Confidential Treatment Requested Under 17C.F.R.Sections 200.80(b)(4), 200.83 and 240.24b-2 - -------------------------------------------------------------------------------- COULTER PHARMACEUTICAL, INC. LOAN AND SECURITY AGREEMENT - -------------------------------------------------------------------------------- 2 TABLE OF CONTENTS
PAGE 1. DEFINITIONS AND CONSTRUCTION.........................................................1 1.1 Definitions...................................................................1 1.2 Accounting Terms..............................................................7 2. LOAN AND TERMS OF PAYMENT............................................................7 2.1 Revolving Facility............................................................7 2.2 Interest Rate Protection......................................................8 2.3 Interest Rates, Payments, and Calculations....................................9 2.4 Crediting Payments...........................................................10 2.5 Fees.........................................................................10 2.6 Additional Costs.............................................................10 2.7 Term.........................................................................11 3. CONDITIONS OF LOANS.................................................................11 3.1 Conditions Precedent to Initial Advance......................................11 4. CREATION OF SECURITY INTEREST.......................................................12 4.1 Grant of Security Interest...................................................12 4.2 Delivery of Additional Documentation Required................................12 4.3 Right to Inspect.............................................................12 4.4 Requirement for Cash Collateral..............................................12 5. REPRESENTATIONS AND WARRANTIES......................................................13 5.1 Due Organization and Qualification...........................................13 5.2 Due Authorization, No Conflict...............................................13 5.3 No Prior Encumbrances........................................................13 5.4 Bona Fide Accounts...........................................................13 5.5 Merchantable Inventory.......................................................13 5.6 Name: Location of Chief Executive Office.....................................13 5.7 Litigation...................................................................13 5.8 No Material Adverse Change in Financial Statements...........................13 5.9 Solvency.....................................................................14 5.10 Regulatory Compliance........................................................14 5.11 Environmental Condition......................................................14
i. 3 TABLE OF CONTENTS (CONTINUED)
PAGE 5.12 Taxes........................................................................14 5.13 Subsidiaries.................................................................14 5.14 Government Consents..........................................................15 5.15 Full Disclosure..............................................................15 6. AFFIRMATIVE COVENANTS...............................................................15 6.1 Good Standing................................................................15 6.2 Government Compliance........................................................15 6.3 Adverse Information..........................................................16 6.4 Financial Statements, Reports, Certificates..................................16 6.5 Inventory; Returns...........................................................17 6.6 Taxes........................................................................17 6.7 Insurance....................................................................17 6.8 Principal Depository.........................................................17 6.9 Total Liabilities-Net Worth Ratio............................................18 6.10 Tangible Net Worth...........................................................18 6.11 Minimum Liquidity; Remaining Months Liquidity; Debt Service Coverage.........18 6.12 Further Assurances...........................................................18 7. NEGATIVE COVENANTS..................................................................18 7.1 Dispositions.................................................................18 7.2 Change in Business...........................................................18 7.3 Mergers or Acquisitions......................................................18 7.4 Indebtedness.................................................................19 7.5 Encumbrances.................................................................19 7.6 Distributions................................................................19 7.7 Investments..................................................................19 7.8 Transactions with Affiliates.................................................19 7.9 Subordinated Debt............................................................19 7.10 Inventory....................................................................19 7.11 Compliance...................................................................19 8. EVENTS OF DEFAULT...................................................................20
ii. 4 TABLE OF CONTENTS (CONTINUED)
PAGE 8.1 Payment Default..............................................................20 8.2 Covenant Default.............................................................20 8.3 Material Adverse Change......................................................20 8.4 Attachment...................................................................20 8.5 Insolvency...................................................................21 8.6 Other Agreements.............................................................21 8.7 Subordinated Debt............................................................21 8.8 Judgments....................................................................21 8.9 Misrepresentations...........................................................21 8.10 FDA Determinations...........................................................21 8.11 Change of Control............................................................21 9. BANKS RIGHTS AND REMEDIES...........................................................21 9.1 Rights and Remedies..........................................................21 9.2 Power of Attorney............................................................23 9.3 Accounts Collection..........................................................23 9.4 Bank Expenses................................................................23 9.5 Bank's Liability for Collateral..............................................23 9.6 Remedies Cumulative..........................................................24 9.7 Demand; Protest..............................................................24 10. NOTICES.............................................................................24 11. CHOICE OF LAW AND VENUE JURY TRIAL WAIVER...........................................25 12. GENERAL PROVISIONS..................................................................25 12.1 Successors and Assigns.......................................................25 12.2 Indemnification..............................................................25 12.3 Time of Essence..............................................................25 12.4 Severability of Provisions...................................................25 12.5 Counterparts.................................................................26 12.6 Survival.....................................................................26 12.7 Confidentiality..............................................................26
iii. 5 LOAN AND SECURITY AGREEMENT THIS LOAN AND SECURITY AGREEMENT is entered into as of October 29, 1998, by and between SILICON VALLEY BANK ("Bank") and COULTER PHARMACEUTICAL, INC. ("Borrower"). RECITALS Borrower wishes to obtain credit from time to time from Bank, and Bank desires to extend credit to Borrower. This Agreement sets forth the terms on which Bank will advance credit to Borrower, and Borrower will repay the amounts owing to Bank. AGREEMENT The parties agree as follows: 1. DEFINITIONS AND CONSTRUCTION. 1.1 DEFINITIONS. As used in this Agreement, the following terms shall have the following definitions: "ACCOUNTS" means all presently existing and hereafter arising accounts, contract rights, and all other forms of obligations owing to Borrower arising out of the sale or lease of goods (including, without limitation, the licensing of software and other technology) or the rendering of services by Borrower, whether or not earned by performance, and any and all credit insurance, guaranties, and other security therefor, as well as all merchandise returned to or reclaimed by Borrower and Borrower's Books relating to any of the foregoing. "ADVANCE" OR "ADVANCES" means cash advances under the Revolving Facility. "AFFILIATE" means, with respect to any Person, any Person that owns or controls directly or indirectly such Person, any Person that controls or is controlled by or is under common control with such Person, and each of such Person's senior executive officers, directors and partners. "BANK EXPENSES" means all: reasonable costs or expenses (including reasonable attorneys' fees and expenses) incurred in connection with the preparation, negotiation, administration, and enforcement of the Loan Documents; and Bank's reasonable attorneys' fees and expenses incurred in amending, enforcing or defending the Loan Documents, whether or not suit is brought. "BORROWER'S BOOKS" means all of Borrower's books and records including: ledgers; records concerning Borrower's assets or liabilities, the Collateral, business operations or financial condition; and all computer programs, or tape files, and the equipment, containing such information. 1. 6 "BUSINESS DAY" means any day that is not a Saturday, Sunday, or other day on which banks in the State of California are authorized or required to close. "CLOSING DATE" means the date of this Agreement. "CODE" means the California Uniform Commercial Code. "COLLATERAL" means the property described on Exhibit A attached hereto. "COMMITTED LOAN AMOUNT" means Ten Million Dollars ($10,000,000). "CONTINGENT OBLIGATION" means, as applied to any Person, any direct or indirect liability, contingent or otherwise, of that Person with respect to (i) any indebtedness, lease, dividend, letter of credit or other obligation of another, including, without limitation, any such obligation directly or indirectly guaranteed, endorsed, co-made or discounted or sold with recourse by that Person, or in respect of which that Person is otherwise directly or indirectly liable; (ii) any obligations with respect to undrawn letters of credit issued for the account of that Person; and (iii) all obligations arising under any interest rate, currency or commodity swap agreement, interest rote cap agreement, interest rate collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; provided, however, that the term "Contingent Obligation" shall not include endorsements for collection or deposit in the ordinary course of business. The amount of any Contingent Obligation shall be deemed to be an amount equal to the stated or determined amount of the primary obligation in respect of which such Contingent Obligation is made or, if not stated or determinable, the maximum reasonably anticipated liability in respect thereof as determined by such Person in good faith; provided, however, that such amount shall not in any event exceed the maximum amount of the obligations under the guarantee or other support arrangement. "DAILY BALANCE" means the amount of the Obligations owed at the end of a given day. "DEBT SERVICE COVERAGE" means, as measured quarterly as of the last day of each fiscal quarter of Borrower, on a consolidated basis determined in accordance with GAAP, the ratio of(a) an amount equal to the sum of(i) net income, plus (ii) depreciation, amortization of intangible assets and other non-cash charges to income, and (iii) accrued interest, to (b) an amount equal to the sum of all scheduled repayments for such quarter (or month, as applicable), including accrued interest, and mandatory prepayments of principal on account of long-term debt. "EQUIPMENT" means all present and furore machinery, equipment, tenant improvements, furniture, fixtures, vehicles, tools, parts and attachments in which Borrower has any interest; provided, however, the term "Equipment" shall not include any equipment related to Borrower's Bexxar technology. "ERISA" means the Employment Retirement Income Security Act of 1974, as amended, and the regulations thereunder. 2. 7 "FDA" means the Food and Drug Administration of the United States government, and any successor regulatory body. "GAAP" means generally accepted accounting principles as in effect from time to time. "GMP" has the meaning set forth in Section 6.2. "INDEBTEDNESS" means (a) all indebtedness for borrowed money or the deferred purchase price of property or services, including without limitation reimbursement and other obligations with respect to surety bonds and letters of credit, (b) all obligations evidenced by notes, bonds, debentures or similar instruments, (e) all capital lease obligations and (d) all Contingent Obligations. "INSOLVENCY PROCEEDING" means any proceeding commenced by or against any person or entity under any provision of the United States Bankruptcy Code, as amended, or under any other bankruptcy or insolvency law, including assignments for the benefit of creditors, formal or informal moratoria, compositions, extension generally with its creditors, or proceedings seeking reorganization, arrangement, or other relief. "INVENTORY" means all present and future inventory in which Borrower has any interest, including merchandise, raw materials, parts, supplies, packing and shipping materials, work in process and finished products intended for sale or lease or to be furnished under a contract of service, of every kind and description now or at any time hereafter owned by or in the custody or possession, actual or constructive, of Borrower, including such inventory as is temporarily out of its custody or possession or in transit and including any returns upon any accounts or other proceeds, including insurance proceeds, resulting from the sale or disposition of any of the foregoing and any documents of title representing any of the above, and Borrower's Books relating to any of the foregoing; provided, however, the term "Inventory" shall not include any Inventory related to Borrower's Bexxar technology. "INVESTMENT" means any beneficial ownership of (including stock, partnership interest or other securities) any Person, or any loan, advance or capital contribution to any Person. "IRC" means the Internal Revenue Code of 1986, as amended, and the regulations thereunder. "LIEN" means any mortgage, lien, deed of trust, charge, pledge, security interest or other encumbrance. "LIQUIDITY" means, at any date of determination, the sum of Borrower's cash, cash equivalents, and short term investments, including (a) fifty percent (50%) of net trade accounts receivable, and (b) up to one hundred percent (100%) of accounts receivable due from certain of Borrower's corporate partners as approved by Bank in Bank's sole discretion, and in such amounts as approved by Bank in Bank's sole discretion, less any cash and cash equivalent balances that are held in a sinking fund for the retirement of debt or capital stock or that are held in pledge for another creditor. 3. 8 "LOAN DOCUMENTS" means, collectively, this Agreement, any note or notes executed by Borrower, and any other agreement entered into between Borrower and Bank in connection with this Agreement, all as amended or extended from time to time. "MATERIAL ADVERSE EFFECT" means a material adverse effect on (i) the business operations or condition (financial or otherwise) of Borrower and its Subsidiaries taken as a whole or (ii) the ability of Borrower to repay the Obligations or otherwise perform its obligations under the Loan Documents. "MATURITY DATE" means the date immediately preceding the fifth (5th) anniversary of the date of this Agreement. "NEGOTIABLE COLLATERAL" means all of Borrower's present and future letters of credit of which it is a beneficiary, notes, drafts, instruments, securities, documents of title, and chattel paper, and Borrower's Books relating to any of the foregoing. "NET CASH LOSSES" means, with respect to any date of determination, determined on a consolidated basis in accordance with GAAP for Borrower and its consolidated Subsidiaries, the reduction in cash from operations (excluding non-recurring charges) during the three months prior to such date of determination or if the date of determination is the last day of a fiscal quarter, during the fiscal quarter then ending (or, if monthly reporting is required pursuant to Section 6.4(c), during the three fiscal months ending prior to such date of determination). For purposes of clarification and not limitation, non-recurring charges to be excluded from the determination of the reduction in cash from operations shall include, without limitation, (a) costs and expenses in radiolabeling infrastructure in connection with the initial build-out of up to three (3) facilities, as to which Borrower will provide supporting invoices and documents upon Bank's request, (b) non-financed capital expenditures and leasehold improvements at 600 Gateway, South San Francisco, California, in conjunction with the initial build-out of the facility, and (c) payments other than regularly scheduled payments of principal and interest under this Agreement. Notwithstanding the foregoing, the annual production campaign charges at BI Pharma and Lonza shall be included in the determination of the reduction in cash from operations on a pro rata basis over the shelf-life of the Inventory produced therefrom. "OBLIGATIONS" means all debt, principal, interest, Bank Expenses and other amounts owed to Bank by Borrower pursuant to this Agreement or any other Loan Document, whether absolute or contingent, due or to become due, now existing or hereafter arising, including any interest that accrues after the commencement of an Insolvency Proceeding and including any debt, liability, or obligation owing from Borrower to others that Bank may have obtained by assignment or otherwise. "PAYMENT DATE" means the 28th calendar day of each month during the term of this Agreement. "PERIODIC PAYMENTS" means all installments or similar recurring payments that Borrower may now or hereafter become obligated to pay to Bank pursuant to the terms and 4. 9 provisions of any instrument, or agreement now or hereafter in existence between Borrower and Bank. "PERMITTED INDEBTEDNESS" means: (a) Indebtedness of Borrower in favor of Bank arising under this Agreement or any other Loan Document; (b) Indebtedness existing on the date of this Agreement and disclosed in the Schedule; (c) Indebtedness to trade creditors incurred in the ordinary course of business; (d) Subordinated Debt; (e) Indebtedness of Borrower to any Subsidiary and Contingent Obligations of any Subsidiary with respect to obligations of Borrower (provided that the primary obligations are not prohibited hereby); Indebtedness of any Subsidiary to any other Subsidiary and Contingent Obligations of any Subsidiary with respect to obligations of any other Subsidiary (provided that the primary obligations are not prohibited hereby); and Contingent Obligations of the Borrower as a guarantor for obligations of its Subsidiaries that (i) are existing on the date of this Agreement, or (ii) have been approved by Bank in writing; (f) Indebtedness secured by Permitted Liens; (g) Capital leases or indebtedness incurred solely to purchase equipment which is secured in accordance with clause (c) of "Permitted Liens" below and is not in excess of the lesser of the purchase price of such equipment or the fair market value of such equipment on the date of acquisition; and (h) Extensions, refinancings, modifications, amendments and restatements of any of items of Permitted Indebtedness (a) through (g) above, provided that the principal amount thereof is not increased or the terms thereof are not modified to impose more burdensome terms upon Borrower or its Subsidiary, as the case may be. "PERMITTED INVESTMENT" means: (a) Investments existing on the Date of this Agreement disclosed in the Schedule; (b) (i) marketable direct obligations issued or unconditionally guaranteed by the United States of America or any agency or any State thereof maturing within one (1) year from the date of acquisition thereof, (ii) commercial paper maturing no more than one (1) year from the date of creation thereof and currently having the highest rating obtainable from either Standard & Poor's Corporation or Moody's Investors Service, Inc., and (iii) certificates of deposit maturing no more than one (1) year from the date of investment therein issued by Bank; 5. 10 (c) Investments accepted in connection with Transfers permitted by Section 7.1; and (d) Investments (whether consisting of the purchase of securities, loans, capital contribution, or otherwise) of Borrower in Subsidiaries and of Subsidiaries in or to other Subsidiaries or in Borrower. "PERMITTED LIENS" means the following: (a) Any Liens existing on the date of this Agreement and disclosed in the Schedule or arising under this Agreement or the other Loan Documents; (b) Liens for taxes, fees, assessments or other governmental charges or levies, either not delinquent or being contested in good faith by appropriate proceedings, provided the same have no priority over any of Bank's security interests, except as provided under applicable law; (c) Liens (i) upon or in any equipment acquired or held by Borrower or any of its Subsidiaries to secure the purchase price of such equipment or indebtedness incurred solely for the purpose of financing the acquisition of such equipment, or (ii) existing on such equipment at the time of its acquisition, provide that the Lien is confined solely to the property so acquired and improvements thereon, and the proceeds of such equipment; (d) Leases or subleases and license and sublicenses granted to others in the ordinary course of Borrower's business not interfering in any material respect with the business of Borrower and its Subsidiaries taken as a whole, and any interest or title of a lessor, licensor or under any lease or license provided that such leases, subleases, licenses and sublicenses do not prohibit the grant of the security interest granted hereunder; and (e) Liens upon intellectual property, including, without limitation, copyrights, patents, trademarks or any licenses thereof, granted to others in connection with collaboration, partnering and similar agreements entered into in the ordinary course of Borrower's business. "PERSON" means any individual, sole proprietorship, partnership, limited liability company, joint venture, trust, unincorporated organization, association, corporation, institution, public benefit corporation, firm, joint stock company, estate, entity or governmental agency. "PRIME RATE" means the variable rate of interest, per annum, most recently announced by Bank, as its "prime rate," whether or not such announced rate is the lowest rate available from Bank. "REMAINING MONTHS LIQUIDITY" OR "RML" means, at the end of each fiscal quarter, or if monthly reporting is required pursuant to Section 6.4(c), as at the end of each calendar month, the ratio of (i) Liquidity at such time to (ii) the monthly average of Net Cash Losses. 6. 11 "RESPONSIBLE OFFICER" means each of the Chief Executive Officer, the Chief Financial Officer and the Controller of Borrower. "REVOLVING FACILITY" means the facility under which Borrower may request cash advances as specified in Section 2.1. "REVOLVING FACILITY AVAILABILITY DATE" means the date immediately preceding the first (1st) anniversary of the date of this Agreement. "SCHEDULE" means the schedule of exceptions attached hereto, if any. "SUBORDINATED DEBT" means any debt incurred by Borrower that is subordinated to the debt owing by Borrower to Bank on terms reasonably acceptable to Bank (and identified as being such by Borrower and Bank), and in connection with which Bank and such subordinated third party has entered into a subordination agreement in form and substance reasonably acceptable to Bank. "SUBSIDIARY" means any corporation or partnership in which (i) any general partnership interest or (ii) more than 50% of the stock of which by the terms thereof ordinary voting power to elect the Board of Directors, managers or trustees of the entity shall, at the time as of which any determination is being made, be owned by Borrower, either directly or through an Affiliate. "TANGIBLE NET WORTH" means at any date as of which the amount thereof shall be determined, the consolidated total assets of Borrower and its Subsidiaries minus, without duplication, (i) the sum of any amounts attributable to (a) goodwill, (b) intangible items such as unamortized debt discount and expense, patents, trade and service marks and names, copyrights and research and development expenses except prepaid expenses, and (c) all reserves not already deducted from assets, and (ii) Total Liabilities. "TOTAL LIABILITIES" means at any date as of which the amount thereof shall be determined, all obligations that should, in accordance with GAAP be classified as liabilities on the consolidated balance sheet of Borrower, including in any event all Indebtedness, but specifically excluding Subordinated Debt. 1.2 ACCOUNTING TERMS. All accounting terms not specifically defined herein shall be construed in accordance with GAAP and all calculations made hereunder shall be made in accordance with GAAP. When used herein, the terms "financial statements" shall include the notes and schedules thereto. 2. LOAN AND TERMS OF PAYMENT. 7. 12 2.1 REVOLVING FACILITY. (a) ADVANCES. Subject to and upon the terms and conditions of this Agreement, following the Closing Date through the Revolving Facility Availability Date, Bank agrees to make Advances to Borrower in an aggregate amount not to exceed the Committed Loan Amount for the purpose of financing capital expenditures and for general working capital. Subject to the terms and conditions of this Agreement, amounts borrowed pursuant to this Section 2.1 may be repaid and reborrowed at any time prior to the Revolving Facility Availability Date, at which time all outstanding Obligations under the Revolving Facility shall convert to a fully amortized term loan, payable as set forth in Section 2.3(c) below. (b) PROCEDURES. Following the Closing Date through the Revolving Facility Availability Date, whenever Borrower desires an Advance, Borrower shall notify Bank by facsimile transmission or telephone no later than 3:00 p.m. California time, one (1) Business Day before the day on which the Advance is requested to be made. Each such notification shall be promptly confirmed by a Payment/Advance Form in substantially the form of Exhibit B hereto and signed by a Responsible Officer. Bank is authorized to make Advances under this Agreement, based upon instructions received from a Responsible Officer, or without instructions if in Bank's discretion such Advances are necessary to meet Obligations which have become due and remain unpaid. Bank shall be entitled to rely on any telephonic notice given by a person who Bank reasonably believes to be a Responsible Officer, and Borrower shall indemnify and hold Bank harmless for any damages or loss suffered by Bank as a result of such reliance. Bank will credit the amount of Advances made under this Section 2.1 to Borrower's deposit account. (c) INTEREST AND PRINCIPAL. Interest shall accrue from the date of each Advance at the rate specified in Section 2.3(a), and shall be payable monthly on the Payment Date for each month through the month in which the Maturity Date falls. Bank shall, at its option, charge such interest, all Bank Expenses, and all Periodic Payments against any of Borrower's deposit accounts, including account number ____________________, or against the Committed Loan Amount, in which case those amounts shall thereafter accrue interest at the rate then applicable hereunder. Any interest not paid when due shall be compounded by becoming a part of the Obligations, and such interest shall thereafter accrue interest at the rate then applicable hereunder. (d) MATURITY. Borrower may only request Advances under the Revolving Facility following the Closing Date through the Revolving Facility Availability Date, at which time the Revolving Facility shall terminate and all outstanding Obligations under the Revolving Facility shall convert to a term loan. On the Maturity Date, all Obligations owing under this Section 2.1 and all other Obligations Borrower owes to Bank under this Agreement shall be immediately due and payable. 2.2 INTEREST RATE PROTECTION. Subject to the terms and condition of this Agreement, Borrower may prepay the Advances, in whole or in part, only upon payment in full of (i) all accrued but unpaid interest and all outstanding obligations hereunder (or, if partial prepayment, an applicable or proportionate amount of such obligations), and (ii), if Borrower has elected the fixed rate option set forth in Section 2.3(a), a fee as shall be determined by Bank in its reasonable discretion in an amount reasonably necessary to provide for interest rate protection in the event the fixed interest rate set forth in Section 2.3(a) is higher than the then current fixed rate. 8. 13 2.3 INTEREST RATES, PAYMENTS, AND CALCULATIONS. (a) INTEREST RATE. Except as set forth in Section 2.3(b), from and after the Closing Date through the Revolving Facility Availability Date, the Advances shall bear interest, on the average daily balance thereof, at a rate equal to one-half of one (.50) percentage point above the Prime Rate. Following the Revolving Facility Availability Date through the Maturity Date, the Advances shall bear interest, on the average daily balance thereof, at a rate equal to, at Borrower's election, either (i) one-half of one (.50) percentage point above the Prime Rate, OR (ii) three and three-quarters (3.75) percentage points above the yield of the 48 month Treasury Note as reported in the Western edition of The Wall Street Journal, which rate shall be fixed at the time of Borrower's election. Borrower shall give written notice to Bank of its interest rate election at any time following the Closing Date but no later than two (2) Business Days prior to the Revolving Facility Availability Date of its interest rate election hereunder. If Borrower fails to give such notice, then the applicable rate shall be the fixed rate option described herein. (b) DEFAULT RATE. All Obligations shall bear interest, from and after the occurrence and during the continuance of an Event of Default, at a rate equal to five (5) percentage points above the interest rate applicable immediately prior to the occurrence of the Event of Default. (c) PAYMENTS. Interest hereunder shall be due and payable on the Payment Date of each month during the term hereof through the month in which the Maturity Date falls. Borrower shall make payments of interest only from and after the Closing Date through the Revolving Facility Availability Date. Following the Revolving Facility Availability Date, Borrower shall, (i) with respect to the fixed rate option, make payments of principal and interest to Bank in forty-eight (48) equal monthly installments of principal and accrued interest, with a final balloon payment of principal plus accrued interest, based on a seven (7) year amortization schedule, which shall be due and payable on the Payment Date of each month during the term hereof, and (ii) with respect to the floating rate option, make payments to Bank in forty-eight (48) equal monthly installments of principal plus accrued interest, based on a seven (7) year amortization schedule, which shall be due and payable on the Payment Date of each month during the term hereof. Borrower's final payment, due on the Maturity Date, shall include all outstanding Advances under the Revolving Facility as converted to a term loan following the Revolving Facility Availability Date, of principal plus all accrued interest not yet paid. Bank shall, at its option, charge such interest, principal, all Bank Expenses, and all Periodic Payments against any of Borrower's deposit accounts, including Account Number _________________ in which case those amounts shall thereafter accrue interest at the rate then applicable hereunder. Any interest not paid when due shall be compounded by becoming a part of the Obligations, and such interest shall thereafter accrue interest at the rate then applicable hereunder. (d) COMPUTATION. In the event the Prime Rate is changed from time to time hereafter, the applicable rate of interest hereunder shall be increased or decreased effective as of 12:01 a.m. on the day the Prime Rate is changed, by an amount equal to such change in the Prime Rate. All interest chargeable under the Loan Documents shall be computed on the basis of a three hundred sixty (360) day year for the actual number of days elapsed. 9. 14 Notwithstanding the foregoing, this Section 2.3(d) shall not apply in the event the Borrower elects the fixed rate option as set forth in Section 2.3(a). 2.4 CREDITING PAYMENTS. Prior to the occurrence and during the continuance of an Event of Default, Bank shall credit a wire transfer of funds, check or other item of payment to such deposit account or Obligation as Borrower specifies. After the occurrence and during the continuance of an Event of Default, the receipt by Bank of any wire transfer of funds, check, or other similar item for the purpose of payment of Obligations shall be immediately applied to conditionally reduce Obligations, but shall not be considered a payment on account unless such payment is of immediately available federal funds or unless and until such check or other item of payment is honored when presented for payment. Notwithstanding anything to the contrary contained herein, any wire transfer or payment received by Bank after 12:00 noon California time shall be deemed to have been received by Bank as of the opening of business on the immediately following Business Day. Whenever any payment to Bank under the Loan Documents would otherwise be due (except by reason of acceleration) on a date that is not a Business Day, such payment shall instead be due on the next Business Day, and additional fees or interest, as the case may be, shall accrue and be payable for the period of such extension. 2.5 FEES. Borrower shall pay to Bank the following: (a) FACILI1Y FEE. A Facility Fee equal to Thirty-Seven Thousand Five Hundred Dollars ($37,500), which fee shall be due and payable on the Closing Date, and shall be fully earned and nonrefundable; (b) FINANCIAL EXAMINATION AND APPRAISAL FEES. Bank's customary fees and out-of-pocket expenses for Bank's audits of Borrower's Accounts, and for each appraisal of Collateral and financial analysis and examination of Borrower performed from time to time by Bank or its agents provided that such audits, appraisals, analyses and examinations shall occur no more frequently than two (2) times per fiscal year if there is no Event of Default or continuing Event of Default; and (c) BANK EXPENSES. Upon the date hereof, all Bank Expenses incurred through the Closing Date, including reasonable attorneys' fees and expenses (not to exceed Seven Thousand Five Hundred Dollars ($7,500) prior to the Closing Date), and, after the date hereof, all Bank Expenses, including reasonable attorneys' fees and expenses as and when they become due; provided, however, Borrower shall be responsible for fifty percent (50%) of all such attorneys' fees and expenses incurred prior to the Closing Date in excess of Seven Thousand Five Hundred Dollars ($7,500). 2.6 ADDITIONAL COSTS. In case any change in any law, regulation, treaty or official directive or the interpretation or application thereof by any court or any governmental authority charged with the administration thereof or the compliance with any guideline or request of any central bank or other governmental authority (whether or not having the force of law), in each case after the date of this Agreement: (a) subjects Bank to any tax with respect to payments of principal or interest or any other amounts payable hereunder by Borrower or otherwise with respect to the 10. 15 transactions contemplated hereby (except for taxes on the overall net income of Bank imposed by the United States of America or any political subdivision thereof); (b) imposes, modifies or deems applicable any deposit insurance, reserve, special deposit or similar requirement against assets held by, or deposits in or for the account of, or loans by, Bank; or (c) imposes upon Bank any other condition with respect to its performance under this Agreement, and the result of any of the foregoing is to increase the cost to Bank, reduce the income receivable by Bank or impose any expense upon Bank with respect to any loans, Bank shall notify Borrower thereof. Borrower agrees to pay to Bank the amount of such increase in cost, reduction in income or additional expense as and when such cost, reduction or expense is incurred or determined, upon presentation by Bank of a statement of the amount and setting forth Bank's calculation thereof, all in reasonable detail which statement shall be deemed true and correct absent manifest error. 2.7 TERM. This Agreement shall become effective on the Closing Date and, subject to Section 12.6, shall continue in full force and effect for a term ending on the Maturity Date. Notwithstanding the foregoing, Bank shall have the right to terminate its obligation to make the Advances under this Agreement immediately and without notice upon the occurrence and during the continuance of an Event of Default. Notwithstanding termination, Bank's Lien on the Collateral shall remain in effect for so long as any Obligations (other than inchoate indemnity obligations) are outstanding. 3. CONDITIONS OF LOANS. 3.1 CONDITIONS PRECEDENT TO INITIAL ADVANCE. The obligation of Bank to make the initial Advance is subject to the conditions precedent that: (a) Bank shall have received, in form and substance satisfactory to Bank, the following: (i) this Agreement; (ii) a certificate of the Secretary of Borrower with respect to incumbency and resolutions authorizing the execution and delivery of this Agreement; (iii) financing statements (Forms UCC-1); (iv) insurance certificate; (v) payment of the fees and Bank Expenses then due specified in Section 2.5 hereof, 11. 16 (vi) timely receipt of the Payment/Advance Form as provided in Section 2.1; (vii) such other documents, and completion of such other matters, as Bank may reasonably deem necessary or appropriate; and (b) the representations and warranties contained in Section 5 shall be true and correct in all material respects on and as of the date of the Payment/Advance Form and on the effective date of each of the Advances, except to the extent such representations and warranties are made as of a specific date, in which case they shall have been accurate on such date, and no Event of Default shall have occurred and be continuing, or would result from each of the Advances. Except as other-wise disclosed to Bank in writing, the making of each of the Advances shall be deemed to be a representation and warranty by Borrower on the date of each of the Advances as to the accuracy of the facts referred to in this Section 3.1(b). 4. CREATION OF SECURITY INTEREST. 4.1 GRANT OF SECURITY INTEREST. Borrower grants and pledges to Bank a continuing security interest in all presently existing and hereafter acquired or arising Collateral in order to secure prompt repayment of any and all Obligations and in order to secure prompt performance by Borrower of each of its covenants and duties under the Loan Documents. Except as set forth in the Schedule, such security interest constitutes a valid, first priority security interest in the presently existing Collateral, and will constitute a valid, first priority security interest in Collateral acquired after the date hereof. 4.2 DELIVERY OF ADDITIONAL DOCUMENTATION REQUIRED. Borrower shall from time to time execute and deliver to Bank, at the request of Bank, all Negotiable Collateral, all financing statements and other documents that Bank may reasonably request, in form satisfactory to Bank, to perfect and continue perfected Bank's security interests in the Collateral and in order to fully consummate all of the transactions contemplated under the Loan Documents. 4.3 RIGHT TO INSPECT. Bank (through any of its officers, employees, or agents) shall have the right, upon reasonable prior notice, from time to time during Borrower's usual business hours, to inspect Borrower's Books and to make copies thereof and to check, test, and appraise the Collateral in order to verify Borrower's financial condition or the amount, condition of, or any other matter relating to, the Collateral; provided, however, such rights under this Section 4.3 shall be exercised at Bank's own expense unless an Event of Default has occurred or is continuing at which time such costs and expenses shall be Borrower's responsibility. 4.4 REQUIREMENT FOR CASH COLLATERAL. Upon Borrower's failure to comply with the financial covenants in Sections 6.8, 6.9, 6.10 and 6.11 the Borrower shall pledge cash in the form of a certificate of deposit at Silicon Valley Bank, on terms reasonably acceptable to Bank, in an amount equal to one hundred percent (100%) of the outstanding loan balances, at which time Borrower shall be deemed to have cured the default under Sections 6.8, 6.9, 6. 10 and 6.11. Notwithstanding the foregoing, Bank shall have no obligation to release the cash pledged pursuant to this Section 4.4(a) unless and until Borrower achieves compliance with all 12. 17 the terms of the Loan Documents, cures any Events of Default and complies with the financial covenants set forth in Sections 6.8, 6.9, 6.10 and 6.11. 5. REPRESENTATIONS AND WARRANTIES. Borrower represents and warrants as follows: 5.1 DUE ORGANIZATION AND QUALIFICATION. Borrower and each Subsidiary is a corporation duly existing and in good standing under the laws of its state of incorporation and qualified and licensed to do business in, and is in good standing in, any state in which the conduct of its business or its ownership of property requires that it be so qualified, except to the extent that failure to so qualify would not have a Material Adverse Effect on Borrower. 5.2 DUE AUTHORIZATION, NO CONFLICT. The execution, delivery, and performance of the Loan Documents are within Borrower's powers, have been duly authorized, and are not in conflict with nor constitute a breach of any provision contained in Borrower's Articles of Incorporation or Bylaws, nor will they constitute an event of default under any material agreement to which Borrower is a party or by which Borrower is bound. Borrower is not in default under any agreement to which it is a party or by which it is bound, which default could have a Material Adverse Effect. 5.3 NO PRIOR ENCUMBRANCES. Borrower has good and indefeasible title to the Collateral, free and clear of Liens, except for Permitted Liens. 5.4 BONA FIDE ACCOUNTS. The Accounts are bona fide existing obligations. The property giving rise to such Accounts has been delivered to the account debtor or to the account debtor's agent or as otherwise instructed by the account debtor for immediate shipment to and unconditional acceptance by the account debtor. Borrower has not received notice of actual or imminent Insolvency Proceeding of any account debtor. 5.5 MERCHANTABLE INVENTORY. All Inventory, net of reserves in accordance with GAAP, is in all material respects of good and marketable quality, free from all material defects. 5.6 NAME: LOCATION OF CHIEF EXECUTIVE OFFICE. Except as disclosed in the Schedule, Borrower has not done business under any name other than that specified on the signature page hereof. The chief executive office of Borrower is located at the address indicated in Section 10 hereof. 5.7 LITIGATION. Except as set forth in the Schedule, there are no actions or proceedings pending by or against Borrower or any Subsidiary before any court or administrative agency in which an adverse decision could reasonably be expected to have a Material Adverse Effect or a material adverse effect on Borrower's interest or Bank's security interest in the Collateral. Borrower does not have knowledge of any such pending or threatened actions or proceedings. 5.8 NO MATERIAL ADVERSE CHANGE IN FINANCIAL STATEMENTS. All consolidated financial statements related to Borrower and any Subsidiary that have been 13. 18 delivered by Borrower to Bank fairly present in all material respects Borrower's consolidated financial condition as of the date thereof and Borrower's consolidated results of operations for the period then ended. There has not been a material adverse change in the consolidated financial condition of Borrower since the date of the most recent of such financial statements submitted to Bank. 5.9 SOLVENCY. The fair salable value of Borrower's assets (including goodwill minus disposition costs) exceeds the fair value of its liabilities; Borrower is not left with unreasonably small capital after the transactions contemplated by this Agreement; and Borrower is able to pay its respective debts (including trade debts) as they mature. 5.10 REGULATORY COMPLIANCE. Borrower and each domestic Subsidiary have met the minimum funding requirements of ERISA with respect to any employee benefit plans subject to ERISA. No event has occurred resulting from Borrower's failure to comply with ERISA that is reasonably likely to result in Borrower's incurring any liability that could have a Material Adverse Effect. Borrower is not an "investment company" or a company "controlled" by an "investment company" within the meaning of the Investment Company Act of 1940. Borrower is not engaged principally, or as one of the important activities, in the business of extending credit for the purpose of purchasing or carrying margin stock (within the meaning of Regulations T and U of the Board of Governors of the Federal Reserve System). Borrower has complied with all the provisions of the Federal Fair Labor Standards Act and Borrower has not violated any statutes, laws, ordinances or rules applicable to it, noncompliance with or which violation of which could reasonably be expected to have a Material Adverse Effect. 5.11 ENVIRONMENTAL CONDITION. Except as disclosed on the Schedule, none of Borrower's or any Subsidiary's properties or assets has ever been used by Borrower or any Subsidiary or, to the best of Borrower's knowledge, by previous owners or operators, in the disposal of, or to produce, store, handle, treat, release, or transport, any hazardous waste or hazardous substance other than in accordance with applicable law; to the best of Borrower's knowledge, none of Borrower's properties or assets has ever been designated or identified in any manner pursuant to any environmental protection statute as a hazardous waste or hazardous substance disposal site, or a candidate for closure pursuant to any environmental protection statute; no lien arising under any environmental protection statute has attached to any revenues or to any real or personal property owned by Borrower or any Subsidiary; and neither Borrower nor any Subsidiary has received a summons, citation, notice, or directive from the Environmental Protection Agency or any other federal, state or other governmental agency concerning any action or omission by Borrower or any Subsidiary resulting in the releasing, or otherwise disposing of hazardous waste or hazardous substances into the environment. 5.12 TAXES. Borrower and each Subsidiary have filed or caused to be filed all tax returns required to be filed, and has paid, or has made adequate provision for the payment of, all taxes reflected therein, except for taxes the amount or validity of which the Borrower is contesting in good faith by appropriate proceedings and with respect to which the Borrower has taken adequate reserves in accordance with GAAP. 5.13 SUBSIDIARIES. Borrower does not own any stock, partnership interest or other equity securities of any Person, except for Permitted Investments. 14. 19 5.14 GOVERNMENT CONSENTS. Borrower and each Subsidiary have obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all governmental authorities that are necessary for the continued operation of Borrower's business as currently conducted. Except as disclosed in writing to Bank, Borrower has not been denied an Investigational New Drug status nor has any application for New Drug Approval been denied, nor has Borrower received any information indicating that the FDA is unlikely to issue an approval letter in response to such application for any products material to Borrower's business. 5.15 FULL DISCLOSURE. No representation, warranty or other statement made by Borrower in any certificate or written statement furnished to Bank contains any untrue statement of a material fact or omits to state a material fact necessary in order to make the statements contained in such certificates or statements not misleading. 6. AFFIRMATIVE COVENANTS. Borrower covenants and agrees that, until payment in full of all outstanding Obligations, and for so long as Bank may have any commitment to make an Advance hereunder, Borrower shall do all of the following: 6.1 GOOD STANDING. Borrower shall maintain its and each of its Subsidiaries' corporate existence and good standing in its jurisdiction of incorporation and maintain qualification in each jurisdiction in which the failure to so qualify could reasonably be expected to have a Material Adverse Effect. Borrower shall maintain, and shall cause each of its Subsidiaries to maintain; to the extent consistent with prudent management of Borrower's business, in force all licenses, approvals and agreements, the loss of which could reasonably be expected to have a Material Adverse Effect. 6.2 GOVERNMENT COMPLIANCE. (a) ERISA. Borrower shall meet, and shall cause each Subsidiary to meet, the minimum funding requirements of ERISA with respect to any employee benefit plans subject to ERISA. (b) FDA. To the extent required by law, Borrower shall cause its, and each of its Subsidiaries', manufacturing and quality control to conform in all material respects to FDA Good Manufacturing Practices ("GMP") regulations and such other regulations applicable to Borrower and its Subsidiaries with respect to advertising, labeling and reporting, product testing, design, safety and labeling of products except where the failure to so conform is not reasonably likely to have a Material Adverse Effect. To the extent necessary to the conduct of its and its Subsidiaries' business, Borrower shall register, and shall cause each of its Subsidiaries to register, with the Food and Drug Branch of the California Department of Health Services and the FDA, and Borrower shall register its, and shall cause each of its Subsidiaries to register their, manufacturing facilities in accordance with GMP regulations. (c) STATUTORY COMPLIANCE. Borrower shall comply, and shall cause each Subsidiary to comply, with all statutes, laws, ordinances and government rules and regulations to which it is subject, noncompliance with which is reasonably likely to have a 15. 20 Material Adverse Effect, including without limitation, compliance in all material respects with the Federal Food, Drug, and Cosmetics Act, the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, and all other applicable federal, state and local laws, orders and regulations. 6.3 ADVERSE INFORMATION. Borrower shall immediately notify Bank upon receipt of any information that indicates that (a) the FDA has denied, or has stated that it is likely to deny, any of Borrower's, or its Subsidiaries', Investigational New Drug Applications or New Product Application, (b) Borrower or a Subsidiary has elected not to proceed with clinical trials for any of Borrower's or Subsidiary's products for which Borrower or any Subsidiary has filed an Investigational New Drug Application with the FDA, or (c) the FDA or other governmental agency has advised Borrower that it found material deficiencies in Borrower's or a Subsidiary's compliance with applicable regulations. 6.4 FINANCIAL STATEMENTS, REPORTS, CERTIFICATES. (a) Borrower shall deliver to Bank: (a) as soon as available, but in any event within thirty (30) days after the end of each fiscal quarter, or within five (5) days of filing with the Securities and Exchange Commission, a company prepared balance sheet and income statement covering Borrower's consolidated operations during such period, in a form certified by an officer of Borrower reasonably acceptable to Bank; (b) as soon as available, but in any event within ninety (90) days after the end of Borrower's fiscal year, or within five (5) days of filing with the Securities and Exchange Commission, audited consolidated financial statements of Borrower prepared in accordance with GAAP, consistently applied, together with an unqualified opinion on such financial statements of an independent certified public accounting firm reasonably acceptable to Bank; (c) within ten (10) days upon becoming available, copies of all statements, reports and notices sent or made available generally by Borrower to its security holders or to any holders of Subordinated Debt and all reports on Form 10-K and 10-Q filed with the Securities and Exchange Commission; and (d) promptly upon receipt of notice thereof, a report of any legal actions pending or threatened against Borrower that could reasonably be expected to result in damages or costs to Borrower of Two Hundred Fifty Thousand Dollars ($250,000) or more; and (e) such budgets, sales projections, operating plans or other financial information as Bank may reasonably request from time to time. (b) Borrower shall deliver to Bank with the quarterly financial statements (or monthly financial statements if required under Section 6.4(c) below), a Compliance Certificate signed by a Responsible Officer in substantially the form of Exhibit Q hereto. (c) If Borrower's Liquidity is (i) less than the product of the amount of outstanding Obligations under this Agreement at any given time multiplied by two and one-half (2.5) (the "Liquidity Multiple"), or (ii) the Remaining Months Liquidity falls below twelve (12) months, Borrower shall deliver to Bank, within thirty (30) days after the last day of each calendar month, a company prepared consolidated balance sheet and income statement covering Borrower's consolidated operations for the relevant month. At such time, and only so long as, Borrower's minimum Liquidity is less than the Liquidity Multiple and Remaining Months Liquidity is less than twelve (12) months, (i) monthly reporting shall continue under this Section 16. 21 6.4(c), and (ii) the minimum Liquidity and Remaining Months Liquidity covenants under Section 6.11 below shall be measured as of the last day of each calendar month. 6.5 INVENTORY; RETURNS. Borrower shall keep all Inventory in good and marketable condition, free from all material defects. Returns and allowances, if any, as between Borrower and its account debtors shall be on the same basis and in accordance with the usual customary practices of Borrower, as they exist at the time of the execution and delivery of this Agreement. Borrower shall promptly notify Bank of all returns and recoveries and of all disputes and claims, where the return, recovery, dispute or claim involves more than One Hundred Thousand Dollars ($ 100,000). 6.6 TAXES. Borrower shall make, and shall cause each Subsidiary to make, due and timely payment or deposit of all material federal, state, and local taxes, assessments, or contributions required of it by law, and will execute and deliver to Bank, on demand, appropriate certificates attesting to the payment or deposit thereof, and Borrower will make, and will cause each Subsidiary to make, timely payment or deposit of all material tax payments and withholding taxes required of it by applicable laws, including, but not limited to, those laws concerning F.I.C.A., F.U.T.A., state disability, and local, state, and federal income taxes, and will, upon request, furnish Bank with proof satisfactory to Bank indicating that Borrower or a Subsidiary has made such payments or deposits; provided that Borrower or a Subsidiary need not make any payment if the amount or validity of such payment is contested in good faith by appropriate proceedings and is reserved against (to the extent required by GAAP) by Borrower. 6.7 INSURANCE. (a) Borrower, at its expense, shall keep the Collateral insured against loss or damage by fire, theft, explosion, sprinklers, and all other hazards and risks, and in such amounts, as ordinarily insured against by other owners in similar businesses conducted in the locations where Borrower's business is conducted on the date hereof. Borrower shall also maintain insurance relating to Borrower's ownership and use of the Collateral in amounts and of a type that are customary to businesses similar to Borrower's. Nothing herein shall be construed as requiring the Borrower to maintain credit insurance with respect to its accounts receivable. (b) All such policies of insurance shall be in such form, with such companies and in such amounts as are reasonably satisfactory to Bank. All such policies of property insurance shall contain a lender's loss payable endorsement, in a form reasonably satisfactory to Bank, showing Bank as an additional loss payee thereof and all liability insurance policies shall show the Bank as an additional insured, and shall specify that the insurer must give at least twenty (20) days notice to Bank before canceling its policy for any reason. Upon Bank's request, Borrower shall deliver to Bank certified copies of such policies of insurance and evidence of the payments of all premiums therefor. All proceeds payable under any such policy shall, at the option of Bank, be payable to Bank to be applied on account of the Obligations. 6.8 PRINCIPAL DEPOSITORY. Borrower shall maintain its principal depository and operating accounts with Bank. Borrower shall maintain a minimum of Five Million Dollars ($5,000,000) in a Bonus Money Market Account with Bank for a minimum period commencing on the Closing Date through the Revolving Facility Availability Date. 17. 22 6.9 TOTAL LIABILITIES-NET WORTH RATIO. Borrower shall maintain, as of the last day of each fiscal quarter during the term of this Agreement, a ratio of Total Liabilities less Subordinated Debt to Tangible Net Worth plus Subordinated Debt of not more than [...***...]. 6.10 TANGIBLE NET WORTH. Borrower shall maintain, as of the last day of each fiscal quarter during the term of this Agreement, a Tangible Net Worth of not less than [...***...] Dollars ($[...***....]). 6.11 MINIMUM LIQUIDITY; REMAINING MONTHS LIQUIDITY; DEBT SERVICE COVERAGE. Subject to the remainder of this section, Borrower shall maintain, as of the last day of each of fiscal quarter, (i) a minimum Liquidity of [...***...] the amount of Obligations under this Agreement, and (ii) Remaining Months Liquidity of at least [...***...]. Notwithstanding the foregoing, from and after the time Borrower achieves a Debt Service Coverage for [...***...] of at least [...***...], and for so long as Borrower maintains as of the last day of each fiscal quarter thereafter, a Debt Service Coverage of at least [...***...], Borrower shall not be subject to the minimum required Liquidity and Remaining Months Liquidity requirements set forth above. 6.12 FURTHER ASSURANCES. At any time and from time to time Borrower shall execute and deliver such further instruments and take such further action as may reasonably be requested by Bank to effect the purposes of this Agreement. 7. NEGATIVE COVENANTS. Borrower covenants and agrees that, so long as any credit hereunder shall be available and until payment in full of the outstanding Obligations or for so long as Bank may have any commitment to make any Advances, Borrower will not do any of the following: 7.1 DISPOSITIONS. Convey, sell, lease, transfer or otherwise dispose of (collectively, a "Transfer"), or pen-nit any of its Subsidiaries to Transfer, all or any part of its business or property, other than Transfers: (i) of inventory in the ordinary course of business, (ii) of non-exclusive licenses and similar arrangements for the use of the property of Borrower or its Subsidiaries in the ordinary course of business, (iii) Transfers of worn- or obsolete Equipment. 7.2 CHANGE IN BUSINESS. Engage in any business, or permit any of its Subsidiaries to engage in any business, other than the businesses currently engaged in by Borrower and any business substantially similar or related thereto (or incidental thereto). Borrower will not, without thirty (30) days prior written notification to Bank, relocate its chief executive office. 7.3 MERGERS OR ACQUISITIONS. Merge or consolidate, or permit any of its Subsidiaries to merge or consolidate, with or into any other business organization, or acquire, or permit any of its Subsidiaries to acquire, all or substantially all of the capital stock or property of another Person; provided that this Section 7.3 shall not apply to any such mergers or acquisitions where (i) Borrower is the surviving entity and is otherwise in compliance with the terms and conditions of this Agreement prior to and following such merger or acquisition, and (ii) - ---------- * CONFIDENTIAL TREATMENT REQUESTED 18. 23 Borrower has first obtained Bank's written approval, such approval not to be unreasonably withheld. 7.4 INDEBTEDNESS. Create, incur, assume or be or remain liable with respect to any Indebtedness, or permit any Subsidiary so to do, other than Permitted Indebtedness. 7.5 ENCUMBRANCES. Create, incur, assume or suffer to exist any Lien with respect to any of its property, or assign or otherwise convey any right to receive income, including the sale of any Accounts, or permit any of its Subsidiaries so to do, except for Permitted Liens. 7.6 DISTRIBUTIONS. Pay any dividends or make any other distribution or payment on account of or in redemption, retirement or purchase of any capital stock. 7.7 INVESTMENTS. Directly or indirectly acquire or own, or make any Investment in or to any Person, or permit any of its Subsidiaries so to do, other than Permitted Investments. 7.8 TRANSACTIONS WITH AFFILIATES. Directly or indirectly enter into or pen-nit to exist any material transaction with any Affiliate of Borrower except for transactions that are in the ordinary course of Borrower's business, upon fair and reasonable terms that are no less favorable to Borrower than would be obtained in an arm's length transaction with a nonaffiliated Person, 7.9 SUBORDINATED DEBT. Make any payment in respect of any Subordinated Debt, or permit any of its Subsidiaries to make any such payment, except in compliance with the terms of such Subordinated Debt, or amend any provision contained in any documentation relating to the Subordinated Debt without Bank's prior written consent. 7.10 INVENTORY. Store the Inventory with a bailee, warehouseman, or similar party unless Bank has received a pledge of the warehouse receipt covering such Inventory. Except for Inventory sold in the ordinary course of business and except for such other locations as Bank may approve in writing, which approval shall not be unreasonably withheld, Borrower shall keep the Inventory only at the location set forth in Section 10 hereof and such other locations of which Borrower gives Bank prior written notice and as to which Borrower signs and files a financing statement where needed to perfect Bank's security interest. 7.11 COMPLIANCE. Become an "investment company" controlled by an "investment company," within the meaning of the Investment Company Act of 1940, or become principally engaged in, or undertake as one of its important activities, the business of extending credit for the purpose of purchasing or carrying margin stock, or use the proceeds of any Advance or Loan for such purpose. Fail to (i) comply in all material respects with FDA's GMP regulations and registration requirements; (ii) comply in all material respects with Federal Food, Drug and Cosmetics Act, the Occupational Safety and Health Act, the Environmental Protection Act, and the Toxic Substances Control Act; (iii) meet the minimum funding requirements of ERISA, permit a reportable event or prohibited transaction, as defined in ERISA, to occur; (iv) comply with the Federal Fair Labor Standards Act in all material respects; or (v) violate any law or regulation, in each case which violation could have a Material Adverse Effect. 19. 24 8. EVENTS OF DEFAULT. Any one or more of the following events shall constitute an Event of Default by Borrower under this Agreement: 8.1 PAYMENT DEFAULT. If Borrower fails to pay the principal of, or any interest on, the Advance when due and payable; or fails to pay any portion of any other Obligations not constituting such principal or interest, including without limitation Bank Expenses, within thirty (30) days of receipt by Borrower of an invoice for such other Obligations; 8.2 COVENANT DEFAULT. If Borrower fails to perform any obligation under Section 6.8, 6.9, 6.10 or 6.11 or violates any of the covenants contained in Article 7 of this Agreement, or fails or neglects to perform, keep, or observe any other material term, provision, condition, covenant, or agreement contained in this Agreement, in any of the Loan Documents, or in any other present or future agreement between Borrower and Bank and as to any default under such other term, provision, condition, covenant or agreement that can be cured, has failed to cure such default within ten (10) days after Borrower receives notice thereof or any officer of Borrower becomes aware thereof, provided, however, that if the default cannot by its nature be cured within the ten (10) day period or cannot after diligent attempts by Borrower be cured within such ten (10) day period, and such default is likely to be cured within a reasonable time, then Borrower shall have an additional reasonable period (which shall not in any case exceed thirty (30) days) to attempt to cure such default, and within such reasonable time period the failure to have cured such default shall not be deemed an Event of Default (provided that no Advance will be required to be made during such cure period); 8.3 MATERIAL ADVERSE CHANGE. If there occurs a material adverse change in Borrower's business or financial condition, or if there is a material impairment of the prospect of repayment of any portion of the Obligations or a material impairment of the value or priority of Bank's security interests in the Collateral; 8.4 ATTACHMENT. If any material portion of Borrower's assets is attached, seized, subjected to a writ or distress warrant, or is levied upon, or comes into the possession of any trustee, receiver or person acting in a similar capacity and such attachment, seizure, writ or distress warrant or levy has not been removed, discharged or rescinded within ten (10) days, or if Borrower is enjoined, restrained, or in any way prevented by court order from continuing to conduct all or any material part of its business affairs, or if a judgment or other claim becomes a lien or encumbrance upon any material portion of Borrower's assets, or if a notice of lien, levy, or assessment is filed of record with respect to any of Borrower's assets by the United States Government, or any department, agency, or instrumentality thereof, or by any state, county, municipal, or governmental agency, and the same is not paid within ten (10) days after Borrower receives notice thereof, provided that none of the foregoing shall constitute an Event of Default where such action or event is stayed or an adequate bond has been posted pending a good faith contest by Borrower (provided that no Advance will be required to be made during such cure period); 20. 25 8.5 INSOLVENCY. If Borrower becomes insolvent, or if an Insolvency Proceeding is commenced by Borrower, or if an Insolvency Proceeding is commenced against Borrower and is not dismissed or stayed within sixty (60) days (provided that no Advance will be made prior to the dismissal of such Insolvency Proceeding); 8.6 OTHER AGREEMENTS. If there is a default in any agreement to which Borrower is a party with a third party or parties resulting in a right by such third party or parties, whether or not exercised, to accelerate the maturity of any Indebtedness in an amount in excess of Two Hundred Fifty Thousand Dollars ($250,000) or that could reasonably be expected to have a Material Adverse Effect; 8.7 SUBORDINATED DEBT. If Borrower makes any payment on account of Subordinated Debt, except to the extent such payment is allowed under any subordination agreement entered into with Bank; 8.8 JUDGMENTS. If a judgment or judgments for the payment of money in an amount, individually or in the aggregate, of at least Two Hundred Fifty Dollars ($100,000) shall be rendered against Borrower and shall remain unsatisfied and unstayed for a period of thirty (30) days (provided that no Advances will be made prior to the satisfaction or stay of such judgment); 8.9 MISREPRESENTATIONS. If any material misrepresentation or material misstatement exists now or hereafter in any warranty or representation set forth herein or in any certificate delivered to Bank by any Responsible Officer pursuant to this Agreement or to induce Bank to enter into this Agreement or any other Loan Document, at the time such representation or warranty was made or such certificate was delivered. 8.10 FDA DETERMINATIONS. If the FDA takes one or more of the following actions with respect to all or substantially all of Borrower's or a Subsidiary's products: (a) withdraws Investigational New Drug status for any such product that is undergoing clinical trials as the result of a determination by the FDA that such product exposes subjects or patients to an unacceptable health risk; (b) withdraws product approval of any such product as the result of any failure to comply with regulatory standards; or (c) determines that such products are not safe or efficacious. 8.11 CHANGE OF CONTROL. If any "person" or "group" (within the meaning of Section 13(d) and 14(d)(2) of the Securities Exchange Act of 1934) becomes the "beneficial owner" (as defined in Rule 13d-3 under the Securities Exchange Act of 1934), directly or indirectly, of a sufficient number of shares of all classes of stock then outstanding of Borrower ordinarily entitled to vote in the election of directors, empowering such "person" or "group" to elect a majority of the Board of Directors of Borrower. 9. BANKS RIGHTS AND REMEDIES. 9.1 RIGHTS AND REMEDIES. Upon the occurrence and during the continuance of an Event of Default, Bank may, at its election, without notice of its election and without demand, do any one or more of the following, all of which are authorized by Borrower: 21. 26 (a) Declare all Obligations, whether evidenced by this Agreement, by any of the other Loan Documents, or otherwise, immediately due and payable (provided that upon the occurrence of an Event of Default described in Section 8.5 all Obligations shall become immediately due and payable without any action by Bank); (b) Cease advancing money or extending credit to or for the benefit of Borrower under this Agreement or under any other agreement between Borrower and Bank; (c) Settle or adjust disputes and claims directly with account debtors for amounts, upon terms and in whatever order that Bank reasonably considers advisable; (d) Without notice to or demand upon Borrower, make such payments and do such acts as Bank considers necessary or reasonable to protect its security interest in the Collateral. Borrower agrees to assemble the Collateral if Bank so requires, and to make the Collateral available to Bank as Bank may designate. Borrower authorizes Bank to enter the premises where the Collateral is located, to take and maintain possession of the Collateral, or any part of it, and to pay, purchase, contest, or compromise any encumbrance, charge, or lien which in Bank's determination appears to be prior or superior to its security interest and to pay all expenses incurred in connection therewith. With respect to any of Borrower's owned premises, Borrower hereby grants Bank a license to enter into possession of such premises and to occupy the same, without charge, for up to one hundred twenty (120) days in order to exercise any of Bank's rights or remedies provided herein, at law, in equity, or otherwise; (e) Without notice to Borrower set off and apply to the Obligations any and all (i) balances and deposits of Borrower held by Bank, or (ii) indebtedness at any time owing to or for the credit or the account of Borrower held by Bank; (f) Ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, advertise for sale, and sell (in the manner provided for herein) the Collateral. Bank is hereby granted a license or other right, solely pursuant to the provisions of this Section 9. 1, to use, without charge, Borrower's labels, patents, copyrights, rights of use of any name, trade secrets, trade names, trademarks, service marks, and advertising matter, or any property of a similar nature, as it pertains to the Collateral, in completing production of, advertising for sale, and selling any Collateral and, in connection with Bank's exercise of its rights under this Section 9. 1, Borrower's rights under all licenses and all franchise agreements shall inure to Bank's benefit; (g) Sell the Collateral at either a public or private sale, or both, by way of one or more contracts or transactions, for cash or on terms, in such manner and at such places (including Borrower's premises) as Bank determines is commercially reasonable, and apply any proceeds to the Obligations in whatever manner or order Bank deems appropriate; (h) Bank may credit bid and purchase at any public sale; and (i) Any deficiency that exists after disposition of the Collateral as provided above will be paid immediately by Borrower. 22. 27 9.2 POWER OF ATTORNEY. Effective only upon the occurrence and during the continuance of an Event of Default, Borrower hereby irrevocably appoints Bank (and any of Bank's designated officers, or employees) as Borrower's true and lawful attorney to: (a) send requests for verification of Accounts or notify account debtors of Bank's security interest in the Accounts; (b) endorse Borrower's name on any checks or other forms of payment or security that may come into Bank's possession; (c) sign Borrower's name on any invoice or bill of lading relating to any Account, drafts against account debtors, schedules and assignments of Accounts, verifications of Accounts, and notices to account debtors; (d) make, settle, and adjust all claims under and decisions with respect to Borrower's policies of insurance; and (e) settle and adjust disputes and claims respecting the accounts directly with account debtors, for amounts and upon terms which Bank determines to be reasonable; (f) to file, in its sole discretion, one or more financing or continuation statements and amendments thereto, relative to any of the Collateral without the signature of Borrower where permitted by law; and (g) to transfer the Collateral into the name of Bank or a third party to the extent permitted under the Code provided Bank may exercise such power of attorney to sign the name of Borrower on any of the documents described in Section 4.2 regardless of whether an Event of Default has occurred. The appointment of Bank as Borrower's attorney in fact, and each and every one of Bank's rights and powers, being coupled with an interest, is irrevocable until all of the Obligations have been fully repaid and performed and Bank's obligation to provide advances hereunder is terminated. 9.3 ACCOUNTS COLLECTION. After the occurrence and during the continuance of an Event of Default, Bank may notify any Person owing funds to Borrower of Bank's security interest in such funds and verify the amount of such Account. Borrower shall collect all amounts owing to Borrower for Bank, receive in trust all payments as Bank's trustee, and immediately deliver such payments to Bank in their original form as received from the account debtor, with proper endorsements for deposit. 9.4 BANK EXPENSES. If Borrower fails to pay any amounts or furnish any required proof of payment due to third persons or entities, as required under the terms of this Agreement, then Bank may do any or all of the following: (a) make payment of the same or any part thereof-, (b) set up such reserves under the Revolving Facility as Bank reasonably deems necessary to protect Bank from the exposure created by such failure; or (c) obtain and maintain insurance policies of the type discussed in Section 6.6 of this Agreement, and take any action with respect to such policies as Bank reasonably deems prudent. Any amounts so paid or deposited by Bank shall constitute Bank Expenses, shall be immediately due and payable, and shall bear interest at the then applicable rate hereinabove provided, and shall be secured by the Collateral. Any payments made by Bank shall not constitute an agreement by Bank to make similar payments in the future or a waiver by Bank of any Event of Default under this Agreement. 9.5 BANK'S LIABILITY FOR COLLATERAL. So long as Bank complies with Section 9207 of the Code, Bank shall not in any way or manner be liable or responsible for: (a) the safekeeping of the Collateral; (b) any loss or damage thereto occurring or arising in any manner or fashion from any cause; (c) any diminution in the value thereof, or (d) any act or default of any carrier, warehouseman, bailee, forwarding agency, or other person whomsoever. All risk of loss, damage or destruction of the Collateral shall be borne by Borrower. 23. 28 9.6 REMEDIES CUMULATIVE. Bank's rights and remedies under this Agreement, the Loan Documents, and all other agreements shall be cumulative. Bank shall have all other rights and remedies not inconsistent herewith as provided under the Code, by law, or in equity. No exercise by Bank of one right or remedy shall be deemed an election, and no waiver by Bank of any Event of Default on Borrower's part shall be deemed a continuing waiver. No delay by Bank shall constitute a waiver, election, or acquiescence by it. No waiver by Bank shall be effective unless made in a written document signed on behalf of Bank and then shall be effective only in the specific instance and for the specific purpose for which it was given. 9.7 DEMAND; PROTEST. Borrower waives demand, protest, notice of protest, notice of default or dishonor, notice of payment and nonpayment, notice of any default, nonpayment at maturity, release, compromise, settlement, extension, or renewal of accounts, documents, instruments, chattel paper, and guarantees at any time held by Bank on which Borrower may in any way be liable. 10. NOTICES. Unless otherwise provided in this Agreement, all notices or demands by any party relating to this Agreement or any other agreement entered into in connection herewith shall be in writing and (except for financial statements and other informational documents which may be sent by first-class mail, postage prepaid) shall be personally delivered or sent by a recognized overnight delivery service, certified mail, postage prepaid, return receipt requested, to Borrower or to Bank, as the case may be, at its addresses set forth below: If to Borrower: Coulter Pharmaceutical, Inc. 550 California Avenue, Suite 200 Palo Alto, CA 94306-1440 Attn: Chief Financial Officer FAX: (650) 849-7530 Phone: (650) 842-7300 with a copy to: Cooley Godward LLP Five Palo Alto Square 3000 El Camino Real Palo Alto, CA 94306-2155 Attn: Robert L. Jones FAX: (650) 857-0663 Phone: (650) 843-5000 If to Bank: Silicon Valley Bank 3003 Tasman Drive P.O. Box 2607 Santa Clara, CA 95054 Attn: [...***...] - ---------- * CONFIDENTIAL TREATMENT REQUESTED 24. 29 FAX: (408) 654-[...***...] Phone: (408) 654-[...***...] The parties hereto may change the address at which they are to receive notices hereunder, by notice in writing in the foregoing manner given to the other. 11. CHOICE OF LAW AND VENUE JURY TRIAL WAIVER. This Agreement shall be governed by, and construed in accordance with, the internal laws of the State of California, without regard to principles of conflicts of law. Each of Borrower and Bank hereby submits to the exclusive jurisdiction of the state and Federal courts located in the County of Santa Clara, State of California. BORROWER AND BANK EACH HEREBY WAIVE THEIR RESPECTIVE RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION BASED UPON OR ARISING OUT OF ANY OF THE LOAN DOCUMENTS OR ANY OF THE TRANSACTIONS CONTEMPLATED THEREIN, INCLUDING CONTRACT CLAIMS, TORT CLAIMS, BREACH OF DUTY CLAIMS, AND ALL OTHER COMMON LAW OR STATUTORY CLAIMS. EACH PARTY RECOGNIZES AND AGREES THAT THE FOREGOING WAIVER CONSTITUTES A MATERIAL INDUCEMENT FOR IT TO ENTER INTO THIS AGREEMENT. EACH PARTY REPRESENTS AND WARRANTS THAT IT HAS REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL AND THAT IT KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING CONSULTATION WITH LEGAL COUNSEL. 12. GENERAL PROVISIONS. 12.1 SUCCESSORS AND ASSIGNS. This Agreement shall bind and inure to the benefit of the respective successors and permitted assigns of each of the parties; provide , however , that neither this Agreement nor any rights hereunder may be assigned by Borrower without Bank's prior written consent, which consent may be granted or withheld in Bank's sole discretion. Bank shall have the right without the consent of or notice to Borrower to sell, transfer, negotiate, or grant participations in all or any part of, or any interest in Bank's obligations, rights and benefits hereunder. 12.2 INDEMNIFICATION. Borrower shall defend, indemnify and hold harmless Bank and its officers, employees, and agents against: (a) all obligations, demands, claims, and liabilities claimed or asserted by any other party in connection with the transactions contemplated by this Agreement; and (b) all losses or Bank Expenses in any way suffered, incurred, or paid by Bank as a result of or in any way arising out of, following, or consequential to transactions between Bank and Borrower whether under this Agreement, or otherwise (including without limitation reasonable attorneys fees and expenses), except for losses caused by Bank's gross negligence or willful misconduct. 12.3 TIME OF ESSENCE. Time is of the essence for the performance of all obligations set forth in this Agreement. 25. 30 12.4 SEVERABILITY OF PROVISIONS. Each provision of this Agreement shall be severable from every other provision of this Agreement for the purpose of determining the legal enforceability of any specific provision. 12.5 COUNTERPARTS. This Agreement may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when executed and delivered, shall be deemed to be an original, and all of which, when taken together, shall constitute but one and the same Agreement. 12.6 SURVIVAL. All covenants, representations and warranties made in this Agreement shall continue in full force and effect so long as any Obligations remain outstanding. The obligations of Borrower to indemnify Bank with respect to the expenses, damages, losses, costs and liabilities described in Section 12.2 shall survive until all applicable statute of limitations periods with respect to actions that may be brought against Bank have run, provided that so long as no Obligations remain outstanding hereunder and Bank has no commitment to make any Advance or to make any other loans to Borrower hereunder, Bank shall release all security interests granted hereunder and redeliver all Collateral held by it in accordance with applicable law. 12.7 CONFIDENTIALITY. As provided in the Nondisclosure Agreement dated as of June 8, 1998, by and between Borrower and Bank, and as provided in this section, in handling any confidential information Bank shall exercise the same degree of care that it exercises with respect to its own proprietary information of the same types to maintain the confidentiality of any non-public information thereby received or received pursuant to this Agreement except that disclosure of such information may be made (i) to the subsidiaries or affiliates of Bank in connection with their present or prospective business relations with Borrower, (ii) to prospective transferees or purchasers of any interest in the Loans, provided that they have entered into a comparable confidentiality agreement in favor of Borrower and have delivered a copy to Borrower, (iii) as required by law, regulations, rule or order, subpoena, judicial order or similar order, (iv) as may be required in connection with the examination, audit or similar investigation of Bank and (v) as Bank may reasonably determine in connection with the enforcement of any remedies hereunder. Confidential information hereunder shall not include information that either: (a) is in the public domain or in the knowledge or possession of Bank when disclosed to Bank, or becomes part of the public domain after disclosure to Bank through no fault of Bank; or (b) is disclosed to Bank by a third party, provided Bank does not have actual knowledge that such third party is prohibited from disclosing such information. 26. 31 IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date first above written. COULTER PHARMACEUTICAL, INC. By:_________________________________ Title:______________________________ SILICON VALLEY BANK By:_________________________________ Title:______________________________ 27. 32 EXHIBIT A The Collateral shall consist of all right, title and interest of Borrower in and to the following: (a) All goods and equipment now owned or hereafter acquired, including, without limitation, all machinery, fixtures, vehicles (including motor vehicles and trailers), and any interest in any of the foregoing, and all attachments, except those which were purchased pursuant to a lease agreement, accessories, accessions, replacements, substitutions, additions, and improvements to any of the foregoing, wherever located; (b) All inventory, now owned or hereafter acquired, including, without limitation, all merchandise, raw materials, parts, supplies, packing and shipping materials, work in process and finished products including such inventory as is temporarily out of Borrower's custody or possession or in transit and including any returns upon any accounts or other proceeds, including insurance proceeds, resulting from the sale or disposition of any of the foregoing and any documents of title representing any of the above, and Borrower's Books relating to any of the foregoing; (c) All contract rights and general intangibles now owned or hereafter acquired, including, without limitation, goodwill, leases, license agreements, franchise agreements, blueprints, drawings, purchase orders, customer lists, route lists, claims, literature, reports, catalogs, income tax refunds, payments of insurance and rights to payment of any kind; (d) All now existing and hereafter arising accounts, contract rights, royalties, license rights and all other forms of obligations owing to Borrower arising out of the sale or lease of goods, the licensing of technology or the rendering of services by Borrower, whether or not earned by performance, and any and all credit insurance, guaranties, and other security therefor, as well as all merchandise returned to or reclaimed by Borrower and Borrower's Books relating to any of the foregoing; (e) All documents, cash, deposit accounts, securities, securities entitlements, financial assets, investment properties, securities accounts, securities entitlements, letters of credit, certificates of deposit, instruments and chattel paper now owned or hereafter acquired and Borrower's Books relating to the foregoing; and (f) Any and all claims, rights and interests in any of the above and all substitutions for, additions and accessions to and proceeds thereof. The term "Collateral" shall not include any inventory and equipment related to Borrower's Bexxar technology. Notwithstanding the foregoing, the term "Collateral" shall not include copyrights, patents, trademarks, licenses or other intellectual property of Borrower except to the extent necessary to perfect Bank's security interest in the proceeds thereof. 28. 33 EXHIBIT B LOAN PAYMENT/ADVANCE TELEPHONE REQUEST FORM DEADLINE FOR SAME DAY PROCESSING IS 3:00 P.M., P.S.T. TO: CENTRAL CLIENT SERVICE DIVISION DATE:_________________ FAX#: (408) 496-2426 TIME:_________________ - -------------------------------------------------------------------------------- FROM: Coulter Pharmaceutical, Inc. --------------------------------------------------------------------------- CLIENT NAME (BORROWER) REQUESTED BY:___________________________________________________________________ AUTHORIZED SIGNER'S NAME AUTHORIZED SIGNATURE:___________________________________________________________ PHONE NUMBER:___________________________________________________________________ FROM ACCOUNT #_______________ TO ACCOUNT # ____________________________________ REQUESTED TRANSACTION TYPE REQUEST DOLLAR AMOUNT PRINCIPAL INCREASE (TERM ADVANCE) $____________________________ PRINCIPAL PAYMENT (ONLY) $____________________________ INTEREST PAYMENT (ONLY) $____________________________ PRINCIPAL AND INTEREST (PAYMENT) $____________________________ OTHER INSTRUCTIONS:_____________________________________________________________ ________________________________________________________________________________ All representations and warranties of Borrower stated in the Loan Agreement are true, correct and complete in all material respects as of the date of the telephone request for and Advance confirmed by this Borrowing Certificate; provided, however, that those representations and warranties expressly referred to another date shall be true, correct and complete in all material respects of such date. ================================================================================ BANK USE ONLY TELEPHONE REQUEST: The following person is authorized to request the loan payment transfer/loan advance on the advance designated account and is known to me. __________________________________ ____________________________________ Authorized Requestor Phone # __________________________________ ____________________________________ Received By (Bank) Phone # _______________________________________ Authorized Signature (Bank) - -------------------------------------------------------------------------------- 29. 34 EXHIBIT C COMPLIANCE CERTIFICATE TO: SILICON VALLEY BANK FROM: COULTER PHARMACEUTICAL, INC. The undersigned authorized officer of Coulter Pharmaceutical, Inc. hereby certifies that in accordance with the terms and conditions of the Loan and Security Agreement between Borrower and Bank (the "Agreement"), (i) Borrower is in complete compliance for the period ending with all required covenants except as noted below and (ii) all representations and warranties of Borrower stated in the Agreement are true and correct in all material respects as of the date hereof, except those representations and warranties made as of a specific date. Attached herewith are the required documents supporting the above certification. The Officer further certifies that these are prepared in accordance with Generally Accepted Accounting Principles (GAAP) and are consistently applied from one period to the next except as explained in an accompanying letter or footnotes. PLEASE INDICATE COMPLIANCE STATUS BY CIRCLING YES/NO UNDER "COMPLIES" COLUMN.
REPORTING COVENANT REQUIRED COMPLIES ------------------ -------- -------- Financial statements(1) Quarterly within 30 days Yes No 10-K I 1O-Q within 10 days Yes No Annual (CPA Audited) FYE within 90 days Yes No
(1) Monthly within 30 days if Liquidity falls below Liquidity Multiple or 12 months RML
Financial Covenant Required Actual Complies Maintain on a Quarterly Basis: Total Liabilities/Tangible Net Worth [...***...] ____:1.0 Yes No Tangible Net Worth $[...***...] $____ Yes No Liquidity(2) [...***...] ____:1.0 Yes No RML(2) [...***...] Yes No Debt Service Coverage(3) [...***...] ____:1.0 Yes No
(2) converts to Debt Service Coverage of 1.5: 1.0 upon two consecutive quarters of compliance with Debt Service Coverage (3) required only upon release of Liquidity and RML requirement COMMENTS REGARDING EXCEPTIONS: See Attached. Sincerely, __________________________________ SIGNATURE __________________________________ TITLE _______________________________________________ BANK USE ONLY Received by:___________________________________ AUTHORIZED SIGNER Date:__________________________________________ Verified:______________________________________ AUTHORIZED SIGNER Date:__________________________________________ Compliance Status: Yes No _______________________________________________ - ---------- * CONFIDENTIAL TREATMENT REQUESTED 30. 35 __________________________________ DATE 31. 36 DISBURSEMENT REQUEST AND AUTHORIZATION Borrower: Coulter Pharmaceutical, Inc. Bank: Silicon Valley Bank ================================================================================ LOAN TYPE. This is a Variable/Fixed Rate, Revolving Facility of a principal amount up to $10,000,000, which converts to a term loan. PRIMARY PURPOSE OF LOAN. The primary purpose of this loan is to finance capital expenditures and to support general working capital purposes. SPECIFIC PURPOSE. The specific purpose of this loan is: General Corporate Purposes. DISBURSEMENT INSTRUCTIONS. Borrower understands that no loan proceeds will be disbursed until all of Bank's conditions for making the loan have been satisfied. Please disburse the loan proceeds as follows:
Revolving Advance ----------------- Amount paid to Borrower directly: $_____ Undisbursed Funds $_____ Principal $_____
CHARGES PAID IN CASH. Borrower has paid or will pay in cash as agreed the following charges: Prepaid Finance Charges Paid in Cash: Facility Fee: $37,500 Other Charges Paid in Cash: $_____ $100 UCC Search Fees $100 UCC Filing Fees $TBD Outside Counsel Fees and Expenses (Estimate) Total Charges Paid in Cash $_____
AUTOMATIC PAYMENTS. Borrower hereby authorizes Bank automatically to deduct from Borrower's account numbered _____ the amount of any loan payment. If the funds in the account are insufficient to cover any payment, Bank shall not be obligated to advance funds to cover the payment. FINANCIAL CONDITION. BY SIGNING THIS AUTHORIZATION, BORROWER REPRESENTS AND WARRANTS TO BANK THAT THE INFORMATION PROVIDED ABOVE IS TRUE AND CORRECT AND THAT THERE HAS BEEN NO ADVERSE C14ANGE IN BORROWER'S FINANCIAL CONDITION AS DISCLOSED IN BORROWER'S MOST RECENT FINANCIAL STATEMENT TO BANK. THIS AUTHORIZATION IS DATED AS OF OCTOBER 29,1998. BORROWER: __________________________________ __________________________________ Authorized Officer 37 AGREEMENT TO PROVIDE INSURANCE Grantor: Coulter Pharmaceutical, Inc. Bank: Silicon Valley Bank ================================================================================ INSURANCE REQUIREMENTS. Coulter Pharmaceutical, Inc. ("Grantor") understands that insurance coverage is required in connection with the extending of a loan or the providing of other financial accommodations to Grantor by Bank. These requirements are set forth in the Loan Documents. The following minimum insurance coverages must be provided on the following described collateral (the "Collateral"): Collateral: All Inventory, Equipment and Fixtures. Type: All risks, including fire, theft and liability. Amount: Full insurable value. Basis: Replacement value. Endorsements: Loss payable clause to Bank with stipulation that coverage will not be canceled or diminished without a minimum of twenty (20) days' prior written notice to Bank. INSURANCE COMPANY. Grantor may obtain insurance from any insurance company Grantor may choose that is reasonably acceptable to Bank. Grantor understands that credit may not be denied solely because insurance was not purchased through Bank. FAILURE TO PROVIDE INSURANCE. Grantor agrees to deliver to Bank, on or before closing, evidence of the required insurance as provided above, with an effective date of October 29, 1998, or earlier. Grantor acknowledges and agrees that if Grantor fails to provide any required insurance or fails to continue such insurance in force, Bank may do so at Grantor's expense as provided in the Loan and Security Agreement. The cost of such insurance, at the option of Bank, shall be payable on demand or shall be added to the indebtedness as provided in the security document. GRANTOR ACKNOWLEDGES THAT IF BANK SO PURCHASES ANY SUCH INSURANCE, THE INSURANCE WILL PROVIDE LIMITED PROTECTION AGAINST PHYSICAL DAMAGE TO THE COLLATERAL, UP TO THE BALANCE OF THE LOAN; HOWEVER, GRANTOR'S EQUITY IN THE COLLATERAL MAY NOT BE INSURED. IN ADDITION, THE INSURANCE MAY NOT PROVIDE ANY PUBLIC LIABILITY OR PROPERTY DAMAGE INDEMNIFICATION AND MAY NOT MEET THE REQUIREMENTS OF ANY FINANCIAL RESPONSIBILITY LAWS. AUTHORIZATION. For purposes of insurance coverage on the Collateral, Grantor authorizes Bank to provide to any person (including any insurance agent or company) all information Bank deems appropriate, whether regarding the Collateral, the loan or other financial accommodations, or both. GRANTOR ACKNOWLEDGES HAVING READ ALL THE PROVISIONS OF THIS AGREEMENT TO PROVIDE INSURANCE AND AGREES TO ITS TERMS. THIS AGREEMENT IS DATED OCTOBER 29,1998. GRANTOR: COULTER PHARMACEUTICAL, INC. __________________________________ Authorized Officer FOR BANK USE ONLY INSURANCE VERIFICATION DATE:_____________________ PHONE:__________________ AGENT'S NAME:______________________________________ INSURANCE COMPANY:_________________________________ POLICY NUMBER:_____________________________________ EFFECTIVE DATES:___________________________________ COMMENTS:__________________________________________ 2. 38 CORPORATE RESOLUTIONS TO BORROW - -------------------------------------------------------------------------------- Borrower: Coulter Pharmaceutical, Inc. - -------------------------------------------------------------------------------- I, the undersigned Secretary or Assistant Secretary of Coulter Pharmaceutical, Inc. (the "Corporation"), HEREBY CERTIFY that the Corporation is organized and existing under and by virtue of the laws of the State of Delaware. I FURTHER CERTIFY that attached hereto as Attachments I and 2 are true and complete copies of the Certificate of Incorporation and Bylaws of the Corporation, each of which is in full force and effect on the date hereof. I FURTHER CERTIFY that at a meeting of the Directors of the Corporation, duly called and held, at which a quorum was present and voting (or by other duly authorized corporate action in lieu of a meeting), the following resolutions were adopted. BE IT RESOLVED, that any one (1) of the following named officers, employees, or agents of this Corporation, whose actual signatures are shown below:
NAMES POSITIONS ACTUAL SIGNATURES ________________________ ______________________ ______________________ ________________________ ______________________ ______________________ ________________________ ______________________ ______________________ ________________________ ______________________ ______________________
acting for an on behalf of this Corporation and as its act and deed be, and they hereby are, authorized and empowered: BORROW MONEY. To borrow from time to time from Silicon Valley Bank ("Bank"), an such terms as may be agreed upon between the officers, employees, or agents and Bank, such sum or sums of money as in their judgment should be borrowed, without limitation, including such sums as are specified in that certain Loan and Security Agreement dated as of October 29, 1998 (the "Loan Agreement"). EXECUTE NOTES. To execute and deliver to Bank the promissory note or notes of the Corporation, on Lender's forms, at such rates of interest and on such terms as may be agreed upon, evidencing the sums of money so borrowed or any indebtedness of the Corporation to Bank, and also to execute and deliver to Lender one or more renewals, extensions, modifications, refinancings, consolidations, or substitutions for one or more of the notes, or any portion of the notes. GRANT SECURITY. To grant a security interest to Bank in the Collateral described in the Loan Agreement, which security interest shall secure all of the Corporation's Obligations, as described in the Loan Agreement. NEGOTIATE ITEMS. To draw, endorse, and discount with Bank all drafts, trade acceptances, promissory notes, or other evidences of indebtedness payable to or belonging to the Corporation 1. 39 or in which the Corporation may have an interest, and either to receive cash for the same or to cause such proceeds to be credited to the account of the Corporation with Bank, or to cause such other disposition of the proceeds derived therefrom as they may deem advisable. FURTHER ACTS. In the case of lines of credit, to designate additional or alternate individuals as being authorized to request advances thereunder, and in all cases, to do and perform such other acts and things, to pay any and all fees and costs, and to execute and deliver such other documents and agreements as they may in their discretion deem reasonably necessary or proper in order to carry into effect the provisions of these Resolutions. BE IT FURTHER RESOLVED, that any and all acts authorized pursuant to these resolutions and performed prior to the passage of these resolutions are hereby ratified and approved, that these Resolutions shall remain in full force and effect and Bank may rely on these Resolutions until written notice of their revocation shall have been delivered to and received by Bank. Any such notice shall not affect any of the Corporation's agreements or commitments in effect at the time notice is given. I FURTHER CERTIFY that the officers, employees, and agents named above are duly elected, appointed, or employed by or for the Corporation, as the case may be, and occupy the positions set forth opposite their respective names; that the foregoing Resolutions now stand of record on the books of the Corporation; and that the Resolutions are in full force and effect and have not been modified or revoked in any manner whatsoever. IN WITNESS WHEREOF, I have hereunto set my hand on October 29, 1998, and attest that the signatures set opposite the names listed above are their genuine signatures. CERTIFIED TO AND ATTESTED BY: X___________________________________ ________________________________________________________________________________ Attachments: 1. Certificate of Incorporation 2. By-Laws 2. 40 This FINANCING STATEMENT is presented for filing and will remain effective with certain exceptions, for a period of five years from the date of filing, pursuant to section 9403 of the California Uniform Commercial Code. - ------------------------------------------------------------------------------------------------------------------------------------ 1. DEBTOR (LAST NAME FIRST-IF AN INDIVIDUAL) 1A. SOCIAL SECURITY OF FEDERAL TAX NO. COULTER PHARMACEUTICAL, INC. - ------------------------------------------------------------------------------------------------------------------------------------ 1B. MAILING ADDRESS 1C. CITY, STATE 1D. ZIP CODE 550 CALIFORNIA AVENUE, SUITE 200 PALO ALTO, CA 94306-1440 - ------------------------------------------------------------------------------------------------------------------------------------ 2. ADDITIONAL DEBTOR (IF ANY) (LAST NAME FIRST-IF AN INDIVIDUAL) 2A. SOCIAL SECURITY OF FEDERAL TAX NO. - ------------------------------------------------------------------------------------------------------------------------------------ 2B. MAILING ADDRESS 2C. CITY, STATE 2D. ZIP CODE - ------------------------------------------------------------------------------------------------------------------------------------ 3. DEBTOR'S TRADE NAMES OF STYLES (IF ANY) 3A. FEDERAL TAX NUMBER ==================================================================================================================================== 4. SECURED PARTY 4A. SOCIAL SECURITY NO., FEDERAL TAX NO. OR BANK TRANSIT AND A.B.A. NO. NAME SILICON VALLEY BANK MAILING ADDRESS 3003 TASMAN DRIVE CITY SANTA CLARA STATE CA ZIP CODE 95054 - ------------------------------------------------------------------------------------------------------------------------------------ 5. ASSIGNEE OF SECURED PARTY (IF ANY) 4A. SOCIAL SECURITY NO., FEDERAL TAX NO. OR BANK TRANSIT AND A.B.A. NO. NAME MAILING ADDRESS CITY STATE ZIP CODE - ------------------------------------------------------------------------------------------------------------------------------------ 6. This FINANCING STATEMENT covers the following types or items of property (include description of real property on which located and owner of record when required by instruction 4). SEE EXHIBIT A ATTACHED HERETO FOR COLLATERAL DESCRIPTION. - ------------------------------------------------------------------------------------------------------------------------------------ 7. CHECK [X] 7A. PRODUCTS OF COLLATERAL 7B. DEBTOR(S) SIGNATURE NOT REQUIRED IN ACCORDANCE WITH IF APPLICABLE [X] ARE ALSO COVERED INSTRUCTION 5(a) ITEM [ ](1) [ ](2) [ ](3) [ ](4) - ------------------------------------------------------------------------------------------------------------------------------------ 8. CHECK [X] [ ] DEBTOR IS A "TRANSMITTING UTILITY" IN ACCORDANCE WITH UCC SEC. 9105(1)(n) IF APPLICABLE - ------------------------------------------------------------------------------------------------------------------------------------ 9. C O 10. THIS SPACE FOR USE OF FILING OFFICER SIGNATURE(S) OF DEBTOR(S) By: /s/ William G. Harris D (DATE, TIME, FILING NUMBER - --------------------------------------------------------------------------------- E AND FILING OFFICER) ----- 1 TYPE OF PRINT NAME(S) OF DEBTOR(S) COULTER PHARMACEUTICAL, INC. - --------------------------------------------------------------------------------- 2 SIGNATURE(S) OF SECURED PARTY(IES) /s/ Dr. Bowman 3 - --------------------------------------------------------------------------------- 4 TYPE OR PRINT NAME(S) OF SECURED PARTY(IES) SILICON VALLEY BANK 5 ================================================================================= 11. Return copy to: 6 NAME 7 ADDRESS CITY 8 STATE ZIP CODE 9 (1) FILING OFFICER COPY FORM UCC-1 0 Approved by the Secretary of State ====================================================================================================================================
41 DEBTOR: COULTER PHARMACEUTICAL, INC. EXHIBIT A The Collateral shall consist of all right, title and interest of Borrower in and to the following: (a) All goods and equipment now owned or hereafter acquired, including, without limitation, all machinery, fixtures, vehicles (including motor vehicles and trailers), and any interest in any of the foregoing, and all attachments, except those which were purchased pursuant to a lease agreement, accessories, accessions, replacements, substitutions, additions, and improvements to any of the foregoing, wherever located; (b) All inventory, now owned or hereafter acquired, including, without limitation, all merchandise, raw materials, parts, supplies, packing and shipping materials, work in process and finished products including such inventory as is temporarily out of Borrower's custody or possession or in transit and including any returns upon any accounts or other proceeds, including insurance proceeds, resulting from the sale or disposition of any of the foregoing and any documents of title representing any of the above, and Borrower's Books relating to any of the foregoing; (c) All contract rights and general intangibles now owned or hereafter acquired, including, without limitation, goodwill, leases, license agreements, franchise agreements, blueprints, drawings, purchase orders, customer lists, route lists, claims, literature, reports, catalogs, income tax refunds, payments of insurance and rights to payment of any kind; (d) All now existing and hereafter arising accounts, contract rights, royalties, license rights and all other forms of obligations owing to Borrower arising out of the sale or lease of goods, the licensing of technology or the rendering of services by Borrower, whether or not earned by performance, and any and all credit insurance, guaranties, and other security therefor, as well as all merchandise returned to or reclaimed by Borrower and Borrower's Books relating to any of the foregoing; (e) All documents, cash, deposit accounts, securities, securities entitlements, financial assets, investment properties, securities accounts, securities entitlements, letters of credit, certificates of deposit, instruments and chattel paper now owned or hereafter acquired and Borrower's Books relating to the foregoing; and (f) Any and all claims, rights and interests in any of the above and an substitutions for, additions and accessions to and proceeds thereof. The term "Collateral" shall not include any inventory and equipment related to Borrower's Bexxar technology. Notwithstanding the foregoing, the term "Collateral" shall not include copyrights, patents and trademarks of Borrower, except to the extent necessary to perfect Bank's security interest in the proceeds thereof,
EX-23.1 11 CONSENT OF ERNST & YOUNG LLP 1 EXHIBIT 23.1 CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS We consent to the incorporation by reference in the Registration Statement on Form S-8 (File No. 333-23265) pertaining to the 1996 Equity Incentive Plan, 1995 Equity Incentive Plan and Employee Stock Purchase Plan of Coulter Pharmaceutical, Inc., of our report dated January 27, 1999, with respect to the consolidated financial statements of Coulter Pharmaceutical, Inc. included in the Annual Report (Form 10-K) for the year ended December 31, 1998. /s/ ERNST & YOUNG LLP Palo Alto, California March 25, 1999 EX-27.1 12 FINANCIAL DATA SCHEDULE
5 YEAR DEC-31-1998 JAN-01-1998 DEC-31-1998 89,808 49,970 0 0 0 142,841 10,469 1,020 153,430 11,578 6,659 0 0 17 135,176 153,430 0 34,250 0 0 40,456 0 385 (1,958) 0 (1,958) 0 0 0 (1,958) (0.13) (0.13)
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