-----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, HZA2X4kn2REs24ycKjZOk0HeOU8QyYok/R1A+PJMrZRzPNIE/cn06NQxA9N81DQM Fz6k8otVFoaMqhseTkBcfg== 0001047469-09-002008.txt : 20090227 0001047469-09-002008.hdr.sgml : 20090227 20090227170629 ACCESSION NUMBER: 0001047469-09-002008 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20081231 FILED AS OF DATE: 20090227 DATE AS OF CHANGE: 20090227 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AMYLIN PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000881464 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330266089 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19700 FILM NUMBER: 09644076 BUSINESS ADDRESS: STREET 1: 9360 TOWNE CENTRE DR STREET 2: SUITE 110 CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 6195522200 MAIL ADDRESS: STREET 1: 9360 TOWNE CENTRE DR STREET 2: SUITE 110 CITY: SAN DIEGO STATE: CA ZIP: 92121 10-K 1 a2190933z10-k.htm 10-K

Table of Contents

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



FORM 10-K


ý

 

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For The Fiscal Year Ended December 31, 2008

OR

o

 

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. 0-19700

AMYLIN PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in its Charter)

Delaware   33-0266089
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification No.)

9360 Towne Centre Drive
San Diego, California

 


92121
(Address of principal executive offices)   (Zip Code)

Registrant's telephone number, including area code: (858) 552-2200

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class   Name of each Exchange on Which Registered
Common Stock, $.001 par value   The NASDAQ Stock Market, LLC

Securities registered pursuant to Section 12(g) of the Act:
NONE
(Title of Class)

          Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ý    No o

          Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o    No ý

          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 ý    No o

          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. ý

          Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definition of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer ý   Accelerated filer o   Non-accelerated filer o
(Do not check if a smaller reporting company)
  Smaller reporting company o

          Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2). Yes o    No ý

          The aggregate market value of the common stock of the registrant as of June 30, 2008 held by non-affiliates was $782,726,805.

          The number of shares outstanding of the registrant's common stock was 138,072,689 as of February 10, 2009.

DOCUMENTS INCORPORATED BY REFERENCE

          Portions of the registrant's Definitive Proxy Statement to be filed with the Securities and Exchange Commission (the "Commission") pursuant to Regulation 14A in connection with the 2009 Annual Meeting of Stockholders to be held on May 27, 2009 are incorporated herein by reference into Part III of this Annual Report. Such Definitive Proxy Statement will be filed with the Commission not later than 120 days after December 31, 2008.


Table of Contents

        You should read the following together with the more detailed information regarding our company, our common stock and our financial statements and notes to those statements appearing elsewhere in this document or incorporated by reference. The Securities and Exchange Commission, or SEC, allows us to "incorporate by reference" information that we file with the SEC, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to be part of this annual report on Form 10-K.

        Except for the historical information contained herein, this annual report on Form 10-K and the information incorporated by reference contains forward-looking statements that involve risks and uncertainties. These statements include projections about our accounting and finances, plans and objectives for the future, future operating and economic performance and other statements regarding future performance. These statements are not guarantees of future performance or events. Our actual results may differ materially from those discussed here. Factors that could cause or contribute to such differences are described in Part I, Item 1A, entitled "Risk Factors," as well as those discussed in Part II, Item 7, entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations," and elsewhere throughout this annual report on Form 10-K and in any other documents incorporated by reference into this annual report on Form 10-K. We disclaim any obligation to update any forward-looking statement.


PART I

Item 1.    Business

Business Overview

        We are a biopharmaceutical company committed to improving the lives of people with diabetes, obesity and other diseases through the discovery, development and commercialization of innovative medicines. We are marketing two first-in-class medicines to treat diabetes, BYETTA® (exenatide) injection and SYMLIN® (pramlintide acetate) injection. Our near-term business strategy is to create value for patients and our stockholders by capitalizing on market drivers, such as the recent inclusion of BYETTA as the only new addition to the treatment guidelines of the American Diabetes Association, or ADA. Our focus remains on increasing BYETTA and SYMLIN revenue, submitting a New Drug Application, or NDA, for exenatide once weekly, significantly improving operating results and progressing toward positive operating cash flow by the end of 2010. Our long term strategy is focused on making prudent investment decisions based on strong clinical data to advance our obesity program. By the end of 2009, we intend to finalize our obesity funding and development strategy.

        BYETTA is the first and only approved medicine in a new class of compounds called glucagon-like peptide-1 (GLP-1) receptor agonists. It is approved as an adjunctive therapy to improve glycemic control in patients with type 2 diabetes who have not achieved adequate glycemic control using metformin, a sulfonylurea and/or a thiazolidinediene (TZD), three common oral therapies for type 2 diabetes. In October 2008, the ADA and the European Association for the Study of Diabetes updated their type 2 diabetes treatment guidelines, placing the GLP-1 receptor agonist class, of which BYETTA is the only approved product, as a secondary treatment option for type 2 diabetes patients. In August 2008, the FDA updated a prior alert for BYETTA referencing pancreatitis. Prescriptions declined in the second half of 2008. During that time period we committed our field resources to educating the medical community on the facts about BYETTA, pancreatitis, and the product's safety profile. We believe the decline in BYETTA prescriptions and demand for the products stabilized at the end of the fourth quarter of 2008. Net product sales of BYETTA were $678.5 million in 2008, $636.0 million in 2007 and $430.2 million in 2006.

        We have an agreement with Eli Lilly and Company, or Lilly, for the global development and commercialization of exenatide. This agreement includes BYETTA and other formulations of exenatide such as exenatide once weekly. Under the terms of the agreement, operating profits from products sold in the United States are shared equally between Lilly and us, and Lilly will pay us royalties for product

1


Table of Contents


sales outside of the United States. Lilly has primary responsibility for developing and commercializing BYETTA outside of the United States, including any sustained release formulations of exenatide such as exenatide once weekly. In late 2006, BYETTA was approved in the European Union, or EU, and, by the end of 2008, BYETTA was commercially launched in 49 countries worldwide.

        SYMLIN is the first and only approved medicine in a new class of compounds called amylinomimetics. It is approved as an adjunctive therapy to improve glycemic control in patients with either type 2 or type 1 diabetes who are treated with mealtime insulin but who have not achieved adequate glycemic control. In early 2008, we introduced the SYMLIN pen-injector device which we believe enables patients to more easily deliver proper dosing than using a vial and syringe and improves the convenience of administering SYMLIN. We own 100% of the global rights to SYMLIN. Net product sales of SYMLIN were $86.8 million in 2008, $65.5 million in 2007 and $43.8 million in 2006.

        We have a field force of approximately 650 people dedicated to marketing BYETTA and SYMLIN in the United States. Our field force includes our specialty and primary care sales forces, a managed care and government affairs organization, a medical science organization and diabetes care specialists. Lilly co-promotes BYETTA in the United States. In May 2008, we amended our United States co-promotion agreement with Lilly, resulting in a 40% increase in the total number of sales representatives promoting BYETTA beginning July 1, 2008. To achieve this increase, Lilly's existing third party sales force for Cialis® (tidafil) co-promotes BYETTA in the United States and we increased the number of sales representatives in our primary care sales force by approximately 15%. In exchange for Lilly sharing in 50% of the costs related to our additional sales representatives and paying 100% of the third party sales force discussed above, our primary care sales force co-promotes Cialis in the United States. We are currently evaluating this element of the co-promotion arrangement with Lilly.

        In addition to our marketed products, we are working with Lilly and Alkermes, Inc., or Alkermes, to develop exenatide once weekly. We are also working with Parsons, Inc., or Parsons, on the construction of a manufacturing facility in Ohio for exenatide once weekly. Construction of this facility was substantially completed in 2008. We are now manufacturing exenatide once weekly at commercial scale in this facility and we began supplying clinical trials with this material in the third quarter of 2008. In October 2008, we received a $125 million cash payment from Lilly representing an amount to compensate us for the cost of carrying Lilly's share of the capital investment made in the manufacturing facility. In addition to the $125 million cash payment, we will recover Lilly's share of the over $500 million capital investment in the facility through an allocation of depreciation to cost of goods sold in accordance with our collaboration agreement with Lilly. The total amount that will ultimately be recovered from Lilly will be dependent upon the proportion of product supplied for sale in the United States, the cost of which is shared equally by the parties, and the proportion of product supplied for sale outside the United States, the cost of which is paid for 100% by Lilly.

        During the second quarter of 2008, we held our pre-NDA meeting with the FDA to discuss open items for our exenatide once weekly regulatory submission. Based on the pre-NDA meeting and our ongoing dialog with the FDA, we continue to believe that the pacing item for an NDA submission is to collect sufficient data to demonstrate the comparability between material manufactured by Alkermes in its facility and used in previous clinical studies and the commercial scale material produced in our Ohio facility. In December 2008, we announced that the FDA has indicated that data from an ongoing extension of our DURATION-1 study could be used to demonstrate comparability. Acceptance by the FDA of the comparability data is dependent upon the DURATION-1 study extension results that we expect to have in early 2009. Although we believe that our exenatide once weekly NDA submission is on track to be completed in the first half of 2009, if we are required to initiate a new clinical study to demonstrate comparability, the timing of the NDA submission would depend on the parameters of the new study, and our submission could be delayed.

2


Table of Contents

        In 2009 we will continue to focus on building a superior profile for exenatide once weekly by conducting three clinical trials that will compare exenatide once weekly against competing products. The objective of these studies is to support the launch of exenatide once weekly and demonstrate superiority and the transformational nature of our exenatide once weekly therapy.

        In November 2008, we announced a strategic restructuring and workforce reduction that reduced the size of our San Diego workforce by approximately 25%, or 330 employees. The goal of the restructuring was to better align our cost structure with anticipated revenues and is part of our business plan to achieve positive operating cash flow by the end of 2010. We believe we have the appropriate resources to market BYETTA and SYMLIN, bring exenatide once weekly to market as soon as possible and continue to advance our obesity programs.

        Our long-term growth strategy is focused on making prudent investment decisions based on strong clinical data to advance our obesity program and includes our Integrated Neurohormonal Treatment of Obesity, or INTO, strategy. In November 2007, we announced that overweight or obese subjects in a 24-week proof-of-concept study treated with a combination of pramlintide, an analog of human amylin and the same active ingredient in SYMLIN, and metreleptin, an analog of human leptin, lost an average of 25 pounds from baseline, resulting in reduced body weight on average of 12.7%. In 2009 we plan to continue the development of a potential obesity medicine that is a combination of pramlintide and metreleptin and the development of a second generation amylinomimetic (AC2307), now known as davalintide, which we have now moved into Phase 2 clinical trials. Data from both of these programs is expected in the second half of 2009. By the end of 2009, we intend to finalize our obesity funding and development strategy.

        Although our efforts will remain focused on our near-term opportunities including BYETTA, SYMLIN and exenatide once weekly, we maintain an active discovery research program focused on novel peptide and protein therapeutics. We have also entered into a number of strategic alliances and business initiatives that support our expansion into new therapeutic areas.

        Our principal executive offices are located at 9360 Towne Centre Drive, San Diego, CA 92121, and our telephone number is (858) 552-2200. We were incorporated in Delaware in September 1987. We maintain a website at www.amylin.com. The reference to our worldwide web address does not constitute incorporation by reference into this report of any of the information contained on our website.

        Our periodic and current reports that we file with the SEC are available free of charge on our website at www.amylin.com as soon as reasonably practicable after we have electronically filed them with, or furnished them to, the SEC.

Diabetes

        Diabetes is a major worldwide health problem and is the fifth leading cause of death by disease in the United States. Diabetes is a complex, metabolic disorder of carbohydrate, fat and protein metabolism, primarily resulting from the failure of pancreatic beta cells to produce sufficient insulin to match the demands for insulin in the body. Insulin is a hormone that plays a central role in helping the body process, convert and store energy from glucose. Another important hormone in glucose regulation is glucagon which is released from the alpha-cells of the pancreas. Its action opposes insulin by increasing glucose appearance in the bloodstream. With the discovery of incretin hormones, GLP-1, gastric inhibitory peptide and the pancreatic hormone amylin, it is now understood that several organs and hormones play a role in maintaining glucose balance in the body. In individuals with diabetes, the relative shortage of insulin impairs the ability of glucose to enter and fuel the body's cells and as a result, glucose builds up in the bloodstream causing hyperglycemia (high blood sugar). Prolonged elevation of blood glucose may result in damage to the kidney, retina and nerves—and may lead to kidney failure, permanent nerve damage, blindness and amputation. High glucose also increases the risk of cardiovascular disease. Conversely, too much insulin in the bloodstream can cause hypoglycemia (low

3


Table of Contents


blood sugar). Individuals who manage their diabetes with insulin or other oral antidiabetic medication are especially vulnerable to swings of high to low blood sugar level and the risk of very low blood sugar which, if left untreated, can be fatal.

        It is estimated that over 240 million people worldwide have diabetes. Of that population, it is estimated that approximately 90-95% have type 2 diabetes, previously known as adult-onset diabetes, and the remainder have type 1 diabetes, previously known as juvenile-onset diabetes. In the United States alone, there are approximately 23.6 million people, or 7.8% of the population, with diabetes. Only 17.9 million of these people have been diagnosed, while 5.7 million people with diabetes have not been diagnosed. From 1980 through 2005, newly diagnosed cases of diabetes among Americans aged 18-79 nearly tripled. In addition, there are currently approximately 57 million people in the United States with pre-diabetes, a condition that raises the risk of developing type 2 diabetes, heart disease and stroke. People with pre-diabetes have blood glucose levels higher than normal but not high enough to establish a diagnosis of diabetes.

        Long term control of blood glucose is known to limit the risk of developing diabetes-related retinal, renal and neurologic complications. Glycated hemoglobin (A1C) is the most widely used measure of long-term blood glucose control. A1C level is a recognized indicator of an individual's average blood glucose concentrations over the preceding three- to four-month period. Lower A1C levels indicate better average blood glucose control, with values in people without diabetes usually being less than 6%. The ADA suggests that people with diabetes should aim for an A1C value that is lower than 7%. It is estimated that less than half of Americans being treated for diabetes are failing to achieve recommended blood glucose levels and, according to research studies conducted in the United States and abroad, these patients would significantly benefit from improved glycemic control. Additionally, aggressive use of insulin and some oral medications to reduce glucose levels can be associated with an increased risk of hypoglycemia and weight gain. Consequently, there has long been a need to develop new treatment strategies that safely improve glucose control, improve the overall health profile of patients with diabetes and reduce the risk of complications.

        In 2008, findings from various long-term clinical trials, including the 10-year follow up of the UK Prospective Diabetes Study and the "Action to Control Cardiovascular Risk in Diabetes, or ACCORD, trial suggested that it is important to treat patients with less advanced diabetes earlier. These studies also suggest that it is important to lower blood glucose without weight gain, associated cardiovascular risk and hypoglycemia which are often associated with older diabetes therapies. The cardiovascular outcomes of these studies suggest that blood glucose control strategies employing weight conscious therapies will be increasingly valued.

        For people suffering from diabetes, poor control of blood glucose levels has been shown to result in severe long-term complications. For instance, the United States Centers for Disease Control, or CDC, has stated that complications due to diabetes include:

    heart disease and stroke;

    high blood pressure;

    blindness due to retinopathy, a condition manifested by damage to the retina;

    nephropathy, or kidney disease;

    neuropathy, a condition where there is damage to the nervous system;

    amputations due to peripheral vascular disease; and

    periodontal disease.

        Obesity is common in patients with type 2 diabetes and weight control is a major problem for many patients with both type 1 and type 2 diabetes. In fact, more than 80% of people with type 2

4


Table of Contents


diabetes are overweight. Weight gain is particularly common in those using insulin and certain oral medications as part of their treatment regimen. In addition, patients with diabetes frequently have wide fluctuations in blood sugar following meals. These fluctuations in blood sugar can significantly affect a patient's quality of life. Blood glucose fluctuations, weight gain and diabetes complications may each contribute to substantial disability, reduced quality of life, reduced productivity in the workplace, increased pain and suffering and premature death. Obesity increases the risk of cardiovascular disease 44% in people with type 2 diabetes and cardiovascular death accounts for three quarters of all deaths among people with diabetes. In fact, the risk of coronary heart disease, cardiovascular disease and death are significantly increased in the overweight population and to an even greater extent in obese patients with type 2 diabetes.

        In 2005, we introduced two new treatment options for the management of diabetes, BYETTA and SYMLIN. BYETTA offers patients with inadequate glycemic control using oral medications the opportunity to better control their blood glucose levels and lose weight. SYMLIN offers patients with inadequate glycemic control using mealtime insulin a treatment option that can both improve glucose control and result in weight loss. These novel first-in-class medicines provide new options in disease management and glucose control to millions of people suffering with diabetes.

Marketed Products

    BYETTA® (exenatide) injection

        BYETTA is the first and only approved medicine in a new class of compounds called incretin mimetics, or GLP-1 receptor agonists. We began selling BYETTA in the United States in June 2005 as an add-on therapy to improve glycemic control in patients with type 2 diabetes who have not achieved adequate glycemic control and who are taking metformin and/or a sulfonylurea, two common oral therapies for type 2 diabetes. Lilly also co-promotes BYETTA in the United States. In December 2006, the FDA approved an additional use for BYETTA as an add-on therapy to improve glycemic control in people with type 2 diabetes who have not achieved adequate glycemic control by using a TZD. We estimate the number of people in the United States currently using metformin, sulfonylurea and/or a TZD to be approximately 8.4 million. Less than half of all diabetes patients using oral medications are believed to have an A1C higher than the ADA's recommendation of less than 7% and the vast majority of these patients could be candidates for BYETTA.

        BYETTA provides glucose control by augmenting the body's natural physiologic processes, allowing the body to respond to blood glucose changes as they occur. BYETTA directly affects the beta cells' responses to elevated glucose by enhancing insulin secretion; this effect dissipates as glucose levels approach the normal range. BYETTA also restores first-phase insulin response, an effect which is evident following the initial dose. BYETTA is administered twice a day by using a fixed dose injection, and requires no dose adjustments due to changes in meal size or composition, exercise or other variables. No additional glucose monitoring is required with BYETTA therapy.

        The most common adverse effect of BYETTA is mild to moderate nausea, which tends to dissipate with time. Mild to moderate hypoglycemia has also been observed, primarily when used in conjunction with a sulfonylurea, agents that are known to cause hypoglycemia.

        In August 2008, the FDA updated a prior alert for BYETTA referencing pancreatitis. Prescriptions for BYETTA declined in the second half of 2008. During that time period we committed our field resources to educating the medical community on the facts about BYETTA, pancreatitis, and the product's safety profile. We believe the decline in BYETTA prescriptions and demand for the products stabilized at the end of the fourth quarter of 2008. We are working to better understand the relationship between BYETTA and pancreatitis described in some spontaneously reported cases. In keeping with our focus on patient safety, we continue to pursue our drug safety program that includes thorough investigation of individual spontaneous case reports along with clinical and epidemiologic

5


Table of Contents


studies. Within the detection limits of an initial epidemiology study which we provided to the FDA, we have not observed an increased incidence of pancreatitis associated with BYETTA compared to other treatments for diabetes and thus believe a definite causal relationship between BYETTA and pancreatitis has not been proved.

        By the end of 2008, our field force expanded to approximately 650 individuals and, together with the Lilly field organization, our goal is to provide education, through both one-on-one interactions and educational programs, to ensure that physicians understand BYETTA, including its mechanisms of action, potential benefits and important use considerations. Primary care physicians write approximately 70% of diabetes prescriptions in the United States. We have refined our marketing efforts to remind primary care physicians of BYETTA's unique benefits of glucose control with weight loss. Additionally, we have access to health care plan reimbursement for BYETTA at over 80% coverage nationally on tier 2, which requires a relatively low co-payment from patients who are covered under such plans.

        Lilly has primary responsibility for developing and commercializing BYETTA outside the United States, including any sustained-release formulations such as exenatide once weekly. In late 2006, we announced that the European Commission granted marketing authorization for BYETTA for the treatment of type 2 diabetes. Lilly commercially launched BYETTA in various EU member states and other countries in 2007 and by the end of 2008 BYETTA was launched in 49 countries worldwide.

        We continue to support initiatives to facilitate the successful initiation of therapy by primary care physicians. This effort includes: increased patient educational material for health care providers to distribute in their offices; a network of approximately 475 diabetes educators to work with physicians and their patients within their local communities; direct support to patients through the BYETTA easy start line, which provides a toll-free number that allows patients to contact trained medical professionals to better understand the benefits of BYETTA therapy and to get assistance starting and using the BYETTA pen; a pharmacy support component partnering with managed care plans designed specifically to assist patient refills; and an enhanced BYETTA website. We believe this support is helpful to patients who may be on their first injectable therapy and to primary care providers who may be less accustomed to treating patients with an injectable product earlier in the disease cycle and who have fewer resources in their offices.

    BYETTA Development Activities

        In April 2005, concurrently with BYETTA's initial approval, the FDA issued an approvable letter for BYETTA when used as a monotherapy (stand-alone therapy) for people with type 2 diabetes. In December 2007, we announced the results of a 24-week BYETTA monotherapy study in drug-naïve patients. In this study participants taking 5 micrograms, or mcg, or 10 mcg of monotherapy BYETTA twice daily showed reductions in A1C by 0.7% and 0.9%, respectively, from an average baseline A1C ranging from 7.8% to 7.9%. In addition, approximately 60% of study participants on either 5 mcg or 10 mcg of monotherapy BYETTA at the conclusion of the study had an A1C of 7% or less. There was a low incidence of nausea reported in both treatment arms of the study of approximately 3% and 13% in the 5 mcg and 10 mcg arms, respectively. There were no instances of severe hypoglycemia in this study. Overall hypoglycemia was similar to that seen in studies where BYETTA was used in conjunction with metformin only.

        In June 2008, we announced additional results from the monotherapy study. Treatment with exenatide resulted in a statistically significant lowering of fasting glucose concentrations in study participants taking 5 or 10 mcg of -17.5 mg/dL and -18.7 mg/dL at endpoint, respectively, compared with placebo reductions of -5.2 mg/dL. Participants taking 5 or 10 mcg also experienced statistically significant weight loss of 6.1 pounds and 6.8 pounds, respectively, compared with weight loss of 3.2 pounds for those taking placebo. In addition, fasting serum lipid profiles, including total cholesterol and high- and low-density lipoprotein, remained unchanged and systolic and diastolic blood pressure levels

6


Table of Contents

improved for participants taking monotherapy BYETTA. We completed a regulatory submission to the FDA for BYETTA use as monotherapy in the first quarter of 2008. In December 2008, we issued an update on the timing of the FDA's review of our submission which we expect to be completed in the first quarter of 2009.

        In September 2008, we announced results from a randomized, double-blind, cross-over, four-week head-to-head study demonstrating that BYETTA provided significantly lower glucose levels in the post-meal setting compared to Januvia™ (sitagliptin), a DPP-4 inhibitor. Additionally, patients treated with BYETTA reduced post-meal glucagon, showed more efficient use of their body's own insulin and decreased their food intake when compared to Januvia. In response to a standard meal, patients treated with BYETTA had significantly improved post-meal glucose levels two hours after the standard meal compared to Januvia. As patients switched from Januvia to BYETTA after two weeks, the post-meal glucose was further improved, while patients who switched from BYETTA to Januvia partially lost the post-meal glucose control achieved with BYETTA. The most common adverse events for both BYETTA and Januvia were mild to moderate nausea and vomiting. There were no major hypoglycemic events; a single event of minor hypoglycemia was reported in a patient treated with BYETTA.

    SYMLIN® (pramlintide acetate) injection

        SYMLIN is the first and only approved medicine in a new class of compounds called amylinomimetics. We began selling SYMLIN in the United States in April 2005 as adjunctive therapy to mealtime insulin to treat diabetes. Other than insulin and insulin analogues, SYMLIN is the first FDA-approved medication addressing glucose control for patients with type 1 diabetes since the discovery of insulin over 80 years ago. SYMLIN is indicated for use in people treated with insulin alone or, in the case of patients with type 2 diabetes, treated with insulin with or without one or more oral medications to help improve blood glucose control.

        SYMLIN works with insulin to smooth out the peaks in blood glucose levels to give patients more stable blood glucose levels after meals and throughout the day. SYMLIN also lowers the A1C levels of most patients beyond what insulin alone can achieve. SYMLIN induces satiety, which leads to eating less and weight loss in most patients. In addition, because SYMLIN works with insulin to control blood sugar, patients often need less insulin to achieve desired blood sugar levels after meals.

        SYMLIN is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia. The risk can be reduced by appropriate patient selection, careful patient instruction and insulin dose adjustments. Other adverse effects commonly observed are primarily gastrointestinal, including nausea, which decrease over time in most patients.

        Our SYMLIN marketing is focused on a target physician population of approximately 20,000, with a goal of educating these physicians on SYMLIN, including its mechanisms of action, potential benefits, use considerations and appropriate patient selection for initiating SYMLIN therapy. These physicians write approximately 31% of all insulin prescriptions in the United States. In January 2008, we announced the availability of the SymlinPen® 120 and the SymlinPen® 60 pen-injector devices for administering SYMLIN. These pre-filled pen-injector devices feature fixed dosing to improve mealtime glucose control and can be stored at room temperature not to exceed 86 degrees F (30 degrees C) after first use. We continue to educate physicians about the SymlinPen and believe the SymlinPen will enable patients to more easily deliver proper dosing than using a vial and syringe and will also improve the convenience of administering SYMLIN. Our near-term goals for SYMLIN are to continue growing SYMLIN prescriptions by highlighting how the product addresses the key unmet needs of patients using mealtime insulin.

7


Table of Contents

    SYMLIN Development Activities

        In June 2008, we published data showing that the use of mealtime SYMLIN with basal insulin therapy for 24 weeks resulted in more type 2 diabetes patients achieving diabetes treatment goals of improved glucose control without weight gain or hypoglycemia compared to the use of rapid-acting insulin with basal insulin. Among those patients treated with mealtime SYMLIN, 1 in 3 achieved this composite set of diabetes treatment goals while only 1 in 10 patients treated with rapid-acting insulin achieved the same result. In October 2007 we received a not approvable letter from the FDA for SYMLIN use with basal insulin and we are in continuing discussions with the FDA.

Research and Development

    Product Pipeline Programs

        We have late-stage and early-stage development programs in the therapeutic areas of diabetes and obesity. Our years of research in diabetes and deep understanding of peptide hormones—their physiology, functionality and impact on the disease—are being leveraged to develop potential treatments for obesity. The metabolic components of these diseases are linked in numerous ways, which are reflected in the impact each has on the other.

Diabetes

    Exenatide Once Weekly

        Exenatide once weekly is our late stage development program in diabetes. Exenatide is the active ingredient in BYETTA and is combined with proprietary technology developed by us and our partner, Alkermes, to provide a sustained release delivery of exenatide. The combination of potency and the glucose-dependent mechanism of action inherent in exenatide makes it well suited to development of a once weekly formulation. We have an agreement with Alkermes to assist us in the development, manufacture and commercialization of exenatide once weekly and this program is included in our collaboration agreement with Lilly. We are aggressively working with Lilly and Alkermes to develop exenatide once weekly and to bring it to market as soon as possible.

        In October 2007, we announced positive results of our DURATION-1 pivotal comparator study comparing treatment with exenatide once weekly to treatment with BYETTA over a 30-week period. The study enrolled 295 patients not achieving adequate glucose control either with use of diet and exercise or with use of oral glucose-lowering agents. Exenatide once weekly showed a statistically significant improvement in A1C of approximately 1.9% from baseline, compared to an improvement of approximately 1.5% for BYETTA. Approximately three out of four subjects treated with exenatide once weekly achieved an A1C of 7% or less.

        After 30 weeks of treatment, both exenatide once weekly and BYETTA treatment resulted in an average weight loss of approximately eight pounds. Nearly 90% of subjects in both groups completed the study. There was no major or severe hypoglycemia regardless of background therapy. As expected, based on prior BYETTA studies, minor hypoglycemia with exenatide once weekly use was limited to subjects using background sulfonylurea therapy. Exenatide once weekly was associated with approximately 30% less nausea than twice-daily BYETTA. Approximately one out of five subjects receiving exenatide once weekly reported treatment-related nausea during the 30-week study. In both groups nausea was predominately mild and transient.

        In June 2008, we announced additional results of our 30-week DURATION-1 study. In addition to showing improvements in A1C, type 2 diabetes patients treated with exenatide once weekly experienced the following effects on several cardiovascular risk factors, including: a reduction of total cholesterol 11.9 mg/dL from a baseline of 173 mg/dL; a reduction of LDL of 4.9 mg/dL from a baseline 91.6 mg/dL; and a reduction of HDL of 0.9 mg/dL from a baseline of 43.9 mg/dL.

8


Table of Contents

        In June 2008, we announced results from a 52-week open-label clinical study that showed the durable efficacy of exenatide once weekly. In this extension of our 30-week DURATION-1 study, patients either remained on exenatide once weekly or switched from BYETTA to exenatide once weekly for an additional 22 weeks. Patients taking exenatide once weekly over the course of one year sustained a similar improvement in glucose control of 2.0% lower A1C and lower fasting plasma glucose from baseline compared to those receiving treatment for 30 weeks who achieved 1.9% lower A1C from baseline.

        This 52-week study also showed that patients who switched from BYETTA after 30 weeks to exenatide once weekly experienced additional improvements in A1C and fasting plasma glucose. Following the 30-week comparison period, patients who continued on exenatide once weekly showed sustained improvements in A1C and fasting plasma glucose while patients who switched from BYETTA to exenatide once weekly had further improvements in glycemic control that were consistent with those patients receiving exenatide once weekly for 52 weeks. Seventy-two percent of patients treated with exenatide once weekly achieved an endpoint A1C of 7% or less and 54% achieved an A1C of 6.5% or less. In patients who switched from BYETTA to exenatide once weekly, 75% of patients achieved an endpoint A1C of 7% or less and 53% achieved an A1C of 6.5% or less. Exenatide once weekly was associated with an average weight loss of 9.5 pounds over 52 weeks. Exenatide once weekly was well tolerated during the first 30 weeks and the following 22-week, open-ended treatment period with overall tolerability improving over the course of the study. No major hypoglycemia events regardless of background therapy were observed with exenatide once weekly. Cases of minor hypoglycemia with exenatide once weekly and BYETTA use were limited to patients using background sulfonylurea therapy. In both groups, nausea was predominately mild and transient and occurred less frequently in exenatide once weekly patients.

        Based on the favorable data from the DURATION-1 study, we have initiated three superiority clinical trials that compare exenatide once weekly against competing products. The purpose of this clinical trial program is to support the launch of exenatide once weekly, if it is approved by the FDA. In the third quarter of 2008, we completed enrollment of our DURATION-2 study, which compares exenatide once weekly against a TZD and a DPP-4 inhibitor on a background of metformin therapy. We expect results from the DURATION-2 study in the second quarter of 2009. We have completed enrollment for our superiority DURATION-3 study, which compares exenatide once weekly against insulin glargine on a background of oral agent therapy. We expect to report results from DURATION-3 in the third quarter of 2009. Finally, in the fourth quarter of 2008, we initiated our DURATION-4 superiority trial comparing exenatide once weekly as a stand-alone therapy to metformin, a TZD or a DPP-4 inhibitor and expect to complete this study in 2010. We believe our DURATION clinical program will provide powerful data that demonstrates the value of this potential medicine to physicians, payors and patients.

        During the second quarter of 2008, we held our pre-NDA meeting with the FDA to discuss open items for our exenatide once weekly regulatory submission. Based on the pre-NDA meeting and our ongoing dialog with the FDA, we continue to believe that the pacing item for an NDA submission is to collect sufficient data to demonstrate the comparability between material manufactured by Alkermes in its facility and used in previous clinical studies and the commercial scale material produced in our Ohio facility. In December 2008, we announced that the FDA has indicated that the data from an ongoing extension of our DURATION-1 study could be used to demonstrate comparability. Acceptance by the FDA of comparability data is dependent upon the DURATION-1 study extension results we expect to have in early 2009. In response to the FDA's recently published guidance on requirements that all investigational new drug (IND) application holders of antidiabetic therapies show that their compounds do not increase the risk of cardiovascular events, we requested feedback from the agency which indicated we can proceed with a meta-analysis of the entire exenatide safety database to evaluate cardiovascular risk. A preliminary analysis of that database indicated there is no increased risk of

9


Table of Contents


cardiovascular events associated with exenatide treatment. An alternative path toward a regulatory submission is to demonstrate comparability by initiating a new bridging study which would likely include both pharmacokinetic and clinical endpoints. Although we believe that our exenatide once weekly NDA submission is on track to be completed in the first half of 2009, if we are required to initiate a new clinical study to demonstrate comparability, the timing of the NDA submission would depend on the parameters of the new study, and our submission could be delayed.

        Given the positive effects on cardiovascular surrogate outcomes observed with exenatide, the encouraging data from the ACCORD trial, which indicates decreased cardiovascular events with BYETTA, and the current regulatory interest in cardiovascular outcomes, we have engaged a steering committee composed of outside experts to assist us in designing a cardiovascular outcomes trial for exenatide once weekly. This study will give us the opportunity to demonstrate the effect of exenatide once weekly on cardiovascular outcomes and other end points of interest to our stakeholders. We do not believe this study will be a requirement for exenatide once weekly approval. We expect interim data from this study to be available in 2012 with final data available in 2016.

    Nasal Exenatide

        In June 2006, we entered into an agreement with Nastech Pharmaceutical Company, or Nastech, to develop a nasal spray formulation of exenatide. In 2008, we reported the results of a nasal exenatide Phase 1 clinical trial which showed that intranasal administration of exenatide was well tolerated and resulted in enhanced glucose-dependent insulin secretion and improved postprandial glucose control. In June 2008, Nastech announced that it had changed its name to MDRNA, Inc., or MDRNA, and that it had initiated a new corporate direction which included seeking to monetize its legacy nasal drug delivery business. We recently amended our agreement with MDRNA to reduce our royalty payment structure and eliminate future milestone payments to MDRNA.

Obesity

        Obesity is a chronic condition that affects millions of people and is linked to increased health risk of several medical conditions including type 2 diabetes, high blood pressure, heart disease, stroke, osteoarthritis, sleep disorders and several types of cancers. Obesity is also rapidly becoming a major health problem in all industrialized nations and many developing countries. According to NAASO (The Obesity Society), obesity is the second leading cause of preventable death in the United States. It is estimated that 64% of the adult population in the United States are overweight and nearly 60 million adult Americans are considered obese. It is also estimated that the total direct and indirect costs attributed to overweight and obesity health issues exceed $100 billion in the United States each year.

        Genetic, metabolic, psychological and environmental factors can all contribute to obesity. Obesity is measured by Body Mass Index, or BMI, a mathematical formula using a person's height and weight. BMI is calculated by dividing a person's weight in kilograms by the person's height in meters squared. A person with a BMI between 25 and 29.9 is considered overweight. A person with a BMI of 30 or more is considered obese, and a person with a BMI of 40 or more is considered severely obese. Current treatments for obesity include diet, exercise, drug therapy and surgery.

        The National Heart, Lung and Blood Institute and the World Health Organization have issued evidence-based guidelines for the identification, evaluation and treatment of obesity. Non-pharmacological treatment modalities (dietary modifications, behavioral interventions and increased physical activity) are considered the cornerstone of clinical obesity management. If lifestyle changes do not promote weight loss after six months, pharmacotherapy is considered helpful for eligible high-risk patients. Only two pharmacological agents are currently approved for the long-term treatment of obesity in the United States. Bariatric surgery is considered an option only for patients with severe obesity and serious co-morbid conditions.

10


Table of Contents

        The National Institutes of Health, Surgeon General and FDA recognize a large unmet medical need for safe and efficacious therapies to prevent the debilitating metabolic diseases and mortality associated with obesity.

Integrated Neurohormonal Therapy for Obesity (INTO)

        Since 2006, we have been executing an obesity strategy to assess the safety and efficacy of multiple neurohormones used in combination to treat obesity. We refer to this strategy as Integrated Neurohormonal Therapy for Obesity, or INTO. Integrated neurohormonal therapy is designed to restore the body's metabolism to a reduced obese or non-obese state by using neurohormones that work together to address the physiologic imbalances that cause complex chronic diseases such as obesity. Our INTO strategy is based on combination therapies and as part of this program we are studying combinations of peptide and protein hormones.

        Three molecular franchises are the primary focus of our INTO strategy: amylin and, in particular, pramlintide, its synthetic version (a first generation amylinomimetic); leptin, and in particular, metreleptin, its recombinant version, a protein hormone produced from the fat cell that plays a fundamental role in metabolism via its communication to the brain; and PYY 3-36, and in particular, a more potent Y-family analog molecule, that is secreted by the gut and provides a satiety signal in the post-meal period. We are also studying a second- generation amylinomimetic, which is a compound that has been optimized in preclinical models to reduce body weight. Our near-term goals for our obesity program are to complete two clinical trials with amylin and leptin analogs and to finalize our obesity funding and development strategy in 2009.

    Pramlintide

        Pramlintide plays an important role in our current INTO strategy. Pramlintide has been studied extensively in people with and without diabetes and is the active ingredient in SYMLIN. In February 2006, we reported results from a 16-week Phase 2 dose-ranging study with pramlintide in obese subjects. After completing 16 weeks of treatment with pramlintide in addition to lifestyle intervention, subjects on average experienced an 8.4 to 13.4 pound weight loss from baseline, compared to a 6.2 pound weight loss with placebo plus lifestyle intervention.

        Pramlintide was well tolerated and showed progressive weight loss at doses up to 360 mcg. No new safety signals were observed in this study, which included higher doses than those previously studied in obese subjects. There was clear evidence of a dose response for the twice-daily regimens. Consistent with previous observations, the most common adverse effect was mild nausea. Weight loss in subjects who did not experience nausea was similar to that seen in the overall study population. In October 2006, we reported results from a continuation of this study that demonstrated that patients completing 52 weeks of pramlintide therapy experienced a 7-8% mean body weight reduction, depending upon the dose they received, compared to a 1% reduction in patients receiving placebo.

        We have conducted clinical studies using pramlintide in combination with leptin and with PYY 3-36. The proof-of-concept pramlintide and metreleptin study, which we discuss below, investigated the synergy of pramlintide and metreleptin found in preclinical studies.

    Metreleptin

        Metreleptin is the second compound we are studying in connection with our INTO program. Metreleptin is the recombinant form of human leptin, a naturally occurring protein hormone secreted by fat cells. Leptin plays a key role in metabolism through multiple metabolic actions and appears to act primarily at the level of the hypothalamus to regulate food intake and energy expenditure. Leptin's roles in the treatment of obesity and lipodystrophy have been extensively studied, and the lead molecules have a strong safety profile. Humans suffering from lipodystrophy, a disease characterized by

11


Table of Contents

loss of body fat and consequent metabolic disorders (insulin resistance, hyperglycemia, and dyslipidemia), are rendered incapable of secreting sufficient amounts of leptin due to the loss of fat cell mass.

        In early 2006, we acquired the exclusive rights to the leptin molecular franchise and program (including metreleptin) from Amgen, Inc., or Amgen. Under the terms of the license agreement, we may make potential future payments related to development and regulatory milestones and will pay royalties on any product sales. Our license includes exclusive rights to the leptin intellectual property developed by Amgen as well as intellectual property Amgen originally licensed from Rockefeller University.

    PYY 3-36

        PYY 3-36 is the third compound we are studying in connection with our INTO program. We are developing more potent and efficacious Y-family mimetics as drug candidates, but have been utilizing the native form of PYY 3-36 for the investigation of potential treatments of obesity. Independent researchers have reported a reduction in food intake in humans using PYY 3-36. In November 2007, we announced data from a 14-day safety and tolerability Phase 1 clinical trial showing that PYY 3-36 when used in combination with pramlintide was well-tolerated. We also announced that this combination was well-tolerated with dose escalation. We intend to focus our future development of the second generation Y-family mimetic either alone or in combination with a second generation amylinomimetic.

    Pramlintide-Metreleptin Combination Product Candidate

        In November 2007, we announced results from a 24-week proof-of-concept study with pramlintide and metreleptin combination treatment in overweight or obese subjects. At the end of the study, the combination treatment reduced body weight on average 12.7%, significantly more than treatment with pramlintide alone (8.4%). Subjects treated with pramlintide and metreleptin lost an average of 25 pounds from the beginning of the study compared with an average of 17 pounds for subjects treated with pramlintide alone. Subjects receiving pramlintide and metreleptin continued to lose weight through the end of the study compared to those treated with pramlintide alone, whose weight loss had stabilized towards the end of the study. At the beginning of the study, the average weight of study participants was approximately 205 pounds.

        Consistent with previous clinical experience with pramlintide and metreleptin as single agents, the most common side effects seen with combination treatment were injection site adverse events and nausea, which were mostly mild to moderate and transient in nature. As a result of this study we are pursuing a pramlintide-metreleptin combination product candidate. In May 2008, we announced the initiation of a six-month Phase 2B clinical study evaluating various dosing combinations of pramlintide and metreleptin and completed enrollment of this study in the third quarter of 2008. The objective of this dose-ranging study is to support dose selection for Phase 3 and to inform the ongoing development of a convenient delivery system for this combination regimen. This double-blind, placebo-controlled study has enrolled approximately 600 subjects and is expected to be completed in the second half of 2009. We plan to continue developing a delivery system that will provide both pramlintide and metreleptin in a single injection.

    Second Generation Amylinomimetic (Davalintide)

        In 2006, we submitted an IND application to the FDA for a second generation amylinomimetic, now known as davalintide (formerly known as AC2307). This product candidate is an amylin analog optimized for obesity with increased potency that offers the potential for enhanced efficacy and less frequent dosing, including once-weekly delivery.

12


Table of Contents

        During 2007, we completed three Phase 1 studies of davalintide which we believe may have some potential advantages over pramlintide for weight loss as a single agent. These advantages may include greater efficacy and improved pharmaceutical properties, such as having prolonged duration of action and being more amenable to drug delivery. These three studies included a single dose study, a twice-daily multi-dose study and a once-daily multi-dose study. In November 2007, we announced data from the twice-daily multi-dose study showing that at 3mcg/kg dosing, individuals exhibited a 996 kilocalorie reduction in intake over a 24-hour period, representing a 34% decrease in daily calories. We have moved the development of davalintide into Phase 2 with a proof-of-concept study evaluating three dosing levels to be administered to approximately 240 patients for six months. The primary efficacy endpoint of the study is body weight. We expect to have results of the study in the second half of 2009.

Research Activities

        A key element of our strategy is to develop first-in-class compounds for treating metabolic diseases. To achieve this goal, we are exploring hormones with multiple mechanisms of action that will potentially lead to products that have utility in treatment of more than one disease with the potential for many product forms. To do so, we take an integrated and biological, rather than a target-driven, approach to research. Our research is centered on peptide hormones that play an important metabolic role, and which we consider more likely to have an acceptable safety profile because these hormones exist naturally in the human body. Our development path begins with identifying a particular peptide and then determining if it is a circulating hormone, a substance that travels through the bloodstream to affect bodily functions. We then attempt to understand the hormone's functionality and potential impact on a disease. Rather than starting with a known biology and targeting molecules to modify, enhance or block it, our scientists are discovering the biology of previously unknown peptides and uncovering utility that could potentially translate into a new human therapy. The conventional development process commonly used in the pharmaceutical industry emphasizes utilizing isolated cells or molecular targets to advance drug discovery. Our approach to research calls for our scientists to quickly move to in vivo testing using highly predictive animal models that allow us to design subsequent information-rich clinical trials in humans.

        Based on a premise that every peptide hormone has a utility—and a potential therapeutic benefit—we have developed a proprietary and continually growing peptide hormone library we call PHORMOL™. PHORMOL encompasses an extensive panel of potentially valuable biologics that have been taken from nature, including human peptides not previously described. All of these have been synthesized to create a rich source of compounds for ongoing research in their functionality, utility and potential value in treating a range of human diseases.

        We are also developing capabilities in delivery system research and development, focused on product presentations that enhance clinical outcomes and patient convenience. Delivery systems are selected on the basis of technical feasibility, regulatory acceptance and market preference. They include injectable sustained-release formulations such as salt complexes, lipids, biodegradable polymer and gel systems, as well as non-injectable systems such as nasal sprays, oral and transdermal systems. We are also using our resources to optimize pharmaceutical properties of peptide drugs to develop new peptide hormone analogs that may be more amenable to alternative forms of delivery.

        We currently have approximately 525 full-time employees dedicated to our research and development activities. In the years ended December 31, 2008, 2007 and 2006, we incurred research and development expense of $293.1 million, $276.6 million and $222.1 million, respectively.

Strategic Relationships

        We have established strategic relationships with other companies and we continue to assess additional opportunities for strategic relationships or in-licensing opportunities. For example, we

13


Table of Contents


partnered with PsychoGenics, Inc. to form Psylin Neurosciences, Inc., or Psylin, a company focused on the discovery and development of peptide hormones for treatment of psychiatric disorders. In addition, we have a joint research collaboration agreement with BioSeek, Inc. that is focusing on the discovery and development of novel peptide therapeutics for inflammatory conditions. We also have a joint research collaboration agreement with Xenome Ltd. Our collaboration with Xenome is focusing on the discovery and development of novel peptide hormones for a range of metabolic and musculoskeletal diseases.

Sales, Marketing and Distribution

        We have built a sales and marketing organization that focuses on healthcare providers, managed healthcare organizations, wholesalers and pharmacies, government purchasers and other third-party payors. We currently have a field force of approximately 650 people dedicated to marketing BYETTA and SYMLIN in the United States. Our field force includes a primary care sales force as well as a specialty sales force of 75 representatives who call on endocrinologists and other physicians who have large diabetes care practices and other healthcare professionals who support their practices. Our field organization also includes a managed care and government affairs organization and a medical science organization that support broad medical education programs for both BYETTA and SYMLIN. Members of our sales and marketing team have extensive industry experience from a wide range of large and small companies and have substantial experience in the field of diabetes, as well as in launching and marketing pharmaceutical products.

        Lilly co-promotes BYETTA in the United States. In May 2008, we amended our United States co-promotion agreement with Lilly, resulting in a 40% increase in the total number of sales representatives promoting BYETTA beginning July 1, 2008. To achieve this increase, Lilly's existing third party sales force for Cialis® (tadafil) co-promotes BYETTA in the United States and we increased the number of sales representatives in our primary care sales force by approximately 15%. In exchange for Lilly sharing in 50% of the costs related to our additional sales representatives and paying 100% of the third party sales force discussed above, our primary care sales force co-promotes Cialis in the United States. We are currently evaluating this element of the co-promotion arrangement with Lilly.

        We utilize common pharmaceutical company practices to market our products. We call on individual physicians and other healthcare professionals and other organizations and individuals involved in the prescribing, purchasing and/or distributing of human medicines. We also provide professional symposia through our extensive medical education programs. Our medical education events are conducted live, via satellite or telephone and through web-based, interactive programs. We will continue to focus on medical education efforts for both BYETTA and SYMLIN through thousands of programs across the United States organized by our medical affairs and professional education organizations. We train physicians and other healthcare professionals as speakers, so that they can in turn teach their peers about how best to incorporate BYETTA or SYMLIN into their patients' diabetes treatment regimens.

        We provide customer service and other related programs for our products, such as disease and product-specific websites, insurance research services, a customer service call center and order, delivery and fulfillment services. We have programs in the United States that provide qualified uninsured and underinsured patients with our products at no charge.

        We sell BYETTA and SYMLIN to wholesale distributors who in turn sell to retail pharmacies and government entities. Decisions made by these wholesalers and their customers regarding the levels of inventory they hold, and thus the amount of BYETTA and SYMLIN they purchase, may affect the level of our product sales in any particular period.

14


Table of Contents

Manufacturing

        We have selected manufacturers that we believe comply with current Good Manufacturing Practices, or cGMP, and other regulatory standards. Manufactured product is used commercially following established registration procedures and after applicable regulatory approvals have been granted. We have established a quality control and quality assurance program, including a set of standard operating procedures, analytical methods and specifications, designed to ensure that our products and product candidates are manufactured in accordance with applicable regulations. We require that our contract manufacturers adhere to cGMP, except for products and product candidates for toxicology and animal studies, which we require to be manufactured in accordance with current Good Laboratory Practices, or cGLP.

        Although some materials for our drug products are currently available from a single-source or a limited number of qualified sources, we attempt to acquire an adequate inventory of such materials, establish alternative sources and/or negotiate long-term supply arrangements. We believe we do not have any significant issues obtaining suppliers; however, we cannot be certain that we will continue to be able to obtain long-term supplies of our manufacturing materials.

    BYETTA Manufacturing

        We obtain exenatide, the active ingredient contained in BYETTA, from Bachem California, or Bachem, and Mallinckrodt, Inc., or Mallinckrodt, pursuant to agreements with each company. We have agreements with Wockhardt UK (Holdings) Ltd., or Wockhardt, and Baxter Pharmaceutical Solutions LLC, a subsidiary of Baxter, Inc., or Baxter, to supply us the dosage form of exenatide in cartridges. We have an agreement with Lilly to supply pens for delivery of BYETTA in cartridges.

    SYMLIN Manufacturing

        We obtain pramlintide acetate, the active ingredient contained in SYMLIN, from Bachem and Lonza Ltd., or Lonza, pursuant to agreements with each company. We have a contract with Baxter for the dosage form of SYMLIN in vials. We also have an agreement with Wockhardt for the dosage form of SYMLIN in cartridges. We have an agreement with Ypsomed AG to supply pen components for the delivery of SYMLIN in cartridges. We also have an agreement with Hollister-Stier Laboratories LLC for the assembly of the SYMLIN pen components and cartridges.

    Exenatide Once Weekly Manufacturing

        Under the terms of our development and license agreement with Alkermes, we are responsible for manufacturing the dosing formulation of exenatide once weekly for commercial sale and will pay Alkermes milestone payments upon achievement of development milestones and royalties on sales of exenatide once weekly. Alkermes has transferred to us its technology for manufacturing exenatide once weekly and will supply us with the polymer materials required for the commercial manufacture of exenatide once weekly. We obtain bulk exenatide, the active ingredient in exenatide once weekly, from Lonza and we obtain pre-filled diluent syringes for exenatide once weekly from Vetter Pharma-Fertigung GMB & Co. KG. pursuant to long-term agreements with both companies.

        We are currently building a facility in West Chester, Ohio to manufacture exenatide once weekly. Construction of this facility was substantially completed in 2008. We are working with Parsons, a group with significant experience in the design and construction of pharmaceutical manufacturing facilities, to complete the design, construction and validation of this facility. We are now manufacturing exenatide once weekly at commercial scale in this facility and we began supplying clinical trials with this material in the third quarter of 2008.

15


Table of Contents

Lilly Collaboration

        We entered into a collaboration agreement with Lilly in 2002 for the global development and commercialization of exenatide, including both the twice-daily version, BYETTA, and sustained-release formulations, such as exenatide once weekly. Under the terms of the agreement, Lilly made initial payments to us, and purchased approximately 1.6 million shares of our common stock. In addition, Lilly has made milestone payments to us upon the achievement of development milestones for BYETTA and exenatide once weekly and commercial milestones for BYETTA. Lilly is also obligated to make additional future commercial milestone payments to us of up to $80 million contingent upon the commercial launch of exenatide, including BYETTA and exenatide once weekly, in selected territories throughout the world. Under our co-promotion arrangement with Lilly, the parties use approximately equal efforts to co-promote BYETTA within the United States and have agreed to use approximately equal efforts to co-promote sustained-release formulations of exenatide within the United States. Lilly is responsible for commercialization efforts outside the United States. We share exenatide United States development and commercialization costs with Lilly equally and we pay Lilly 50% of the operating profits from the sale of products in the United States. Our collaboration agreement may be terminated by Lilly at any time on six months' notice.

        In late 2006, BYETTA was approved in the EU and, by the end of 2008, was commercially launched in 49 countries worldwide. Lilly will pay us tiered royalties based upon the annual gross margin for all exenatide product sales, including any sustained-release formulations, outside of the United States. Royalty payments for exenatide product sales outside the United States will commence after a one-time cumulative gross margin threshold has been met. Lilly is responsible for 100% of the costs related to development of twice-daily BYETTA for sale outside of the United States. Development costs related to all other exenatide products for sale outside of the United States will continue to be allocated 80% to Lilly and 20% to us. Lilly is responsible for 100% of the costs related to commercialization of all exenatide products for sale outside the United States. We record all United States BYETTA product revenues and Lilly records all BYETTA product revenues from outside the United States.

        In October 2008, we entered into an Exenatide Once Weekly Supply Agreement with Lilly pursuant to which we will supply commercial quantities of exenatide once weekly for sale in the United States, if approved by the FDA. In addition, if Lilly receives approval to market the product in jurisdictions outside the Unites States, we will be required to manufacture the product intended for commercial sale by Lilly in those jurisdictions. We have also entered into a loan agreement with Lilly pursuant to which Lilly will make a $165 million unsecured line of credit available to us that we can draw upon from time to time beginning on December 1, 2009 and ending on June 30, 2011, with maturity no later than June 30, 2014.

Competition

        The biotechnology and pharmaceutical industry is highly competitive. There are many pharmaceutical companies, biotechnology companies, public and private universities and research organizations actively engaged in the research and development of products that may be similar to the products in our portfolio. A number of our largest competitors, including AstraZeneca, Bristol-Myers Squibb Company, GlaxoSmithKline, Lilly, Merck & Co., Novartis AG, Novo Nordisk, Pfizer, Sanofi-Aventis and Takeda Pharmaceuticals, are pursuing the development of or are marketing pharmaceuticals that target the same diseases that we are targeting, and it is probable that the number of companies seeking to develop products and therapies for the treatment of diabetes, obesity and other metabolic disorders will increase. Many of these and other existing or potential competitors have substantially greater financial, technical and human resources than we do and may be better equipped to develop, manufacture and market products. These companies may develop and introduce products and processes competitive with or superior to ours. In addition, other technologies or products may be

16


Table of Contents


developed that have an entirely different approach or means of accomplishing the intended purposes of our products, which might render our technology and products noncompetitive or obsolete. For example, all of our current drug products are injectable, and may have to compete with therapies that do not require injection. We cannot be certain that we will be able to compete successfully.

        SYMLIN is the only non-insulin-based drug product approved for improving blood glucose control in people with type 1 diabetes. Further, insulin and oral medications are often insufficient for many people with type 2 diabetes to achieve satisfactory glucose and weight control. BYETTA or SYMLIN may be complementary to, or competitive with, these other medications.

        BYETTA and SYMLIN must compete with established therapies for market share. In addition, many companies are pursuing the development of novel pharmaceuticals that target diabetes. These companies may develop and introduce products competitive with or superior to BYETTA or SYMLIN. Such competitive products and potential products include:

    sulfonylureas;

    metformin;

    insulins (injectable and inhaled versions);

    thiazolidinediones (TZDs);

    glinides;

    dipeptidyl peptidase type IV (DPP-IV) inhibitors;

    incretin/GLP-1 agonists;

    insulin sensitizers, including PPARs;

    alpha-glucosidase inhibitors; and

    sodium-glucose transporter-2 (SGLT-2) inhibitors.

        There is substantial competition in the discovery and development of treatments for obesity, as well as emerging prescription and over-the-counter treatments for this condition. Current treatments for obesity include dietary therapy, physical activity, drug therapy and surgery. Hoffmann-LaRoche and Abbott Laboratories already market oral medicines for the treatment of obesity. Glaxo Smith Kline now markets a former prescription product (orlistat-Alli) for treatment of obesity. In addition, a number of other pharmaceutical companies are developing new potential therapeutics.

Patents, Proprietary Rights, and Licenses

        We believe that patents and other proprietary rights are important to our business. Our policy is to file patent applications to protect technology, inventions and improvements that may be important to the development of our business. We also rely upon trade secrets, know-how, continuing technological innovations and licensing opportunities to develop and maintain our competitive position. We plan to enforce our issued patents and our rights to proprietary information and technology. We review third-party patents and patent applications, both to refine our own patent strategy and to identify useful licensing opportunities.

        We have a number of patents, patent applications and rights to patents related to our compounds, products and technology, but we cannot be certain that issued patents will be enforceable or provide adequate protection or that pending patent applications will result in issued patents. We have also filed foreign counterparts to many of these issued patents and applications.

        We may obtain patents for our compounds many years before we obtain marketing approval for them. Because patents have a limited life, which may begin to run prior to the commercial sale of the

17


Table of Contents


related product, the commercial value of the patent may be limited. However, we may be able to apply for patent term extensions to compensate in part for delays in obtaining marketing approval. For example, in the United States a patent term extension of 1,586 days has been granted for SYMLIN and a patent term extension of 1,287 days has been granted for BYETTA. Similar patent term extensions may be available for other products that we are developing, but we cannot be certain we will obtain them.

        Included within our exenatide patent portfolio are issued patents for:

    pharmaceutical compositions containing exenatide;

    modulating gastric emptying;

    inhibiting glucagon secretion;

    stimulating insulin release; and

    reducing food intake.

        These patents expire between 2013 and 2020. We do not have a composition of matter patent for the exenatide molecule.

        Included within our pramlintide patent portfolio are issued patents for:

    pramlintide and other amylin agonist analogues invented by our researchers;

    amylin agonist pharmaceutical compositions, including compositions containing pramlintide; and

    methods for treating diabetes and related conditions using amylin agonists.

        These patents expire between 2011 and 2018.

        Our SYMLIN and BYETTA products are subject to the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act, which provides data exclusivity for a certain period of time. Once this exclusivity period expires, the Hatch-Waxman Act allows generic manufacturers to file Abbreviated New Drug Applications, or ANDA, with the FDA requesting approval of generic versions of previously-approved products. For example, a generic pharmaceutical manufacturer could file an ANDA for SYMLIN as early as March 2009 and for BYETTA as early as April 2009. If an ANDA is filed for one of our approved products prior to expiration of the patents covering those products, it could result in our initiating patent infringement litigation to enforce our rights.

        With respect to our drug candidates, we have patents and patent applications pending, or have licensed patents and patent applications, relevant to the development and commercialization of such drug candidates. Generally, our policy is to file foreign counterpart applications in countries with significant pharmaceutical markets.

        It is important that we do not infringe patents or proprietary rights of others and that we do not violate the agreements that grant proprietary rights to us. If we do infringe patents or violate these agreements, we could be prevented from developing or selling products or from using the processes covered by those patents or agreements, or we could be required to obtain a license from the third party allowing us to use their technology. We cannot be certain that, if required, we could obtain a license to any third-party technology or that we could obtain one at a reasonable cost. If we were not able to obtain a required license, we could be adversely affected. Because patent applications are confidential for at least some period of time, there may be pending patent applications from which patents will eventually issue and prevent us from developing or selling certain products unless we can obtain a license to use the patented technology.

18


Table of Contents

        Patents relating to pharmaceutical, biopharmaceutical and biotechnology products, compounds and processes such as those that cover our existing products, compounds and processes and those that we will likely file in the future do not always provide complete or adequate protection. Future litigation or proceedings initiated by the United States Patent and Trademark Office regarding the enforcement or validity of our existing patents or any future patents could invalidate our patents or substantially reduce their protection. In addition, statutory or regulatory changes may adversely affect our ability to obtain protection or enforce our patents. Furthermore, our pending patent applications and patent applications filed by our collaborative partners may not result in the issuance of any patents or may result in patents that do not provide adequate protection. As a result, we may not be able to prevent third parties from developing the same compounds and products that we have developed or are developing. In addition, we do not have patent protection or we may not be able to enforce our patents in certain countries. As a result, manufacturers may be able to sell generic versions of our products in those countries.

        We also rely on unpatented trade secrets and improvements, unpatented internal know-how and technological innovation. We protect these rights mainly through confidentiality agreements with our corporate partners, employees, consultants and vendors. These agreements provide that all confidential information developed or made known to an individual during the course of their relationship with us will be kept confidential and will not be used or disclosed to third parties except in specified circumstances. In the case of employees, the agreements provide that all inventions made by the individual while employed by us will be our exclusive property. We cannot be certain that these parties will comply with these confidentiality agreements, that we have adequate remedies for any breach, or that our trade secrets will not otherwise become known or be independently discovered by our competitors. Under some of our research and development agreements, inventions discovered in certain cases become jointly owned by us and our corporate partner and in other cases become the exclusive property of one of us. It can be difficult to determine who owns a particular invention and disputes could arise regarding those inventions.

Government Regulation

        Regulation by governmental authorities in the United States and foreign countries is a significant factor in the development, manufacture and marketing of pharmaceutical products. All of our potential products will require regulatory approval by governmental agencies prior to commercialization. In particular, human therapeutic products are subject to rigorous preclinical testing and clinical trials and other pre-market approval requirements by the FDA and regulatory authorities in foreign countries. Various federal, state and foreign statutes and regulations also govern or influence the manufacturing, safety, labeling, storage, record keeping and marketing of such products.

        A number of steps must be taken before a pharmaceutical agent may be marketed in the United States. First, the pharmaceutical agent must undergo preclinical testing. Preclinical tests include laboratory evaluation of product chemistry and animal studies to assess the potential safety and activity of the product candidate and its formulations. The results of these studies must be submitted to the FDA as part of an IND which must be reviewed by the FDA before a proposed clinical trial can begin. Typically, clinical trials involve a three-phase process. In Phase 1, clinical trials are conducted with a small number of healthy volunteers to determine the early safety and tolerability profile and the pattern of drug distribution and metabolism. In Phase 2, clinical trials are conducted with groups of patients afflicted with a specified disease in order to determine preliminary efficacy, dosing regimens and expanded evidence of safety. In Phase 3, large-scale, multi-center, adequate and well-controlled comparative clinical trials are conducted with patients afflicted with a target disease in order to provide enough data for the statistical proof of efficacy and safety required by the FDA and others. The results of the preclinical testing and clinical trials for a pharmaceutical product are then submitted to the FDA in the form of an NDA for approval to commence commercial sales. In responding to an NDA, the

19


Table of Contents


FDA may grant marketing approval, request additional information, or deny the application if it determines that the application does not satisfy its regulatory approval criteria. Once a drug is approved for marketing in the United States, the FDA requires ongoing safety monitoring to ascertain any undiscovered issues related to "real-world" use of the drug. The expanded patient exposure once a drug is introduced to the marketplace can reveal new risks (as well as new benefits) that were not detectable during clinical testing.

        Among the conditions for NDA approval is the requirement that the prospective manufacturer's quality control and manufacturing procedures conform to cGMP. In complying with cGMP, manufacturers must continue to expend time, money and effort in the area of production, quality control, and quality assurance to ensure full technical compliance. Manufacturing facilities are subject to periodic inspections by the FDA to ensure compliance.

        We are also subject to various federal, state, and local laws, regulations and recommendations relating to safe working conditions; laboratory and manufacturing practices; the experimental use of animals; and the use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research.

        The activities required before a pharmaceutical agent may be marketed in the EU are dictated by the International Conference on Harmonization and are generally similar to those established in the United States. Approval of new drugs across the EU relies on either the mutual recognition or decentralized approval procedure of the European Medicines Agency. Under the centralized procedure, the marketing application is referred for review to two review teams, each representing one of the member countries. Each reviewer then forwards an early assessment to the Committee for Medicinal Products for Human Use, or CHMP, for discussion and preparation of an initial consolidated assessment report, including a list of questions requesting clarification as well as additional information. This step initiates a series of dialogues, meetings and other communications among the CHMP, the two review teams and the applicant, leading in turn to clarification, education and refinement of the original assessment reports. Ultimately, a decision is reached to either grant marketing approval or deny the application if it is determined that the application does not satisfy the regulatory approval criteria. The clinical testing, manufacture and sale of pharmaceutical products outside of the United States and the EU are subject to regulatory approvals by other jurisdictions which may be more or less rigorous than those required by the United States or the EU.

Employees

        As of December 31, 2008, we had approximately 1,800 full-time employees. A significant number of our management and professional employees have had experience with pharmaceutical, biotechnology or medical product companies. We believe that we have been highly successful in attracting skilled and experienced personnel. None of our employees is covered by collective bargaining agreements and we consider relations with our employees to be good.

20


Table of Contents

Directors and Executive Officers

        The names of our directors and executive officers and certain information about them as of February 15, 2009 are set forth below:

Name
  Age   Position

Daniel M. Bradbury(1)

    47   President, Chief Executive Officer and Director

Joseph C. Cook, Jr.(1)

    67   Chairman of the Board

Adrian Adams(2)

    58   Director

Steven R. Altman(2)

    47   Director

Teresa Beck(3)

    54   Director

Karin Eastham(2)(3)

    59   Director

James R. Gavin III, M.D., Ph.D.(4)

    63   Director

Ginger L. Graham(1)

    53   Director

Howard E. Greene, Jr.(1)

    66   Director

Jay S. Skyler, M.D., MACP(4)

    62   Director

Joseph P. Sullivan(1)(3)

    66   Director

James N. Wilson(2)(4)

    65   Director

Craig A. Eberhard

    49   Vice President, Sales

Mark G. Foletta

    48   Senior Vice President, Finance and Chief Financial Officer

Mark J. Gergen

    46   Senior Vice President, Corporate Development

Orville G. Kolterman, M.D. 

    61   Senior Vice President, Research and Development

Marcea Bland Lloyd

    60   Senior Vice President, Government and Corporate Affairs, and General Counsel

Roger Marchetti

    50   Senior Vice President, Human Resources and Information Management

Paul G. Marshall

    49   Senior Vice President, Operations

Vincent P. Mihalik

    58   Senior Vice President, Sales and Marketing and Chief Commercial Officer

Lloyd A. Rowland

    52   Vice President, Governance and Compliance, and Corporate Secretary

(1)
Member of the Finance Committee.

(2)
Member of the Compensation and Human Resources Committee.

(3)
Member of the Audit Committee.

(4)
Member of the Corporate Governance Committee.

        Mr. Bradbury has been our Chief Executive Officer since March 2007, serving as President since June 2006 and as Chief Operating Officer since June 2003. He has served as a director since June 2006. He previously served as Executive Vice President from June 2000 until his promotion in June 2003. He joined Amylin in 1994 and has held officer-level positions in Corporate Development and Marketing during that time. Prior to joining Amylin, Mr. Bradbury spent ten years at SmithKline Beecham Pharmaceuticals, where he held a number of sales and marketing positions. He is a member of the board of directors of Illumina, Inc. He also serves on the RAND Health Board of Advisors and as a board member for PhRMA, BIOCOM, the Keck Graduate Institute's Board of Trustees and the San Diego Regional Economic Development Corporation. Mr. Bradbury is a member of the Royal Pharmaceutical Society of Great Britain and serves on the UCSD Rady School of Management's Advisory Council. He received a Bachelor of Pharmacy from Nottingham University and a Diploma in Management Studies from Harrow and Ealing Colleges of Higher Education.

21


Table of Contents

        Mr. Cook has been our Chairman of the Board since March 1998 and serves on our Finance Committee. He served as Chief Executive Officer from March 1998 until September 2003. From 1994 to 1998, Mr. Cook served as a member of our Board and a consultant to us. Mr. Cook is a founder and serves as Chairman of the Board of Microbia, Inc., a privately held biotechnology company. He also serves as a director of Corcept Therapeutics Incorporated. Mr. Cook is a founder of Mountain Group Capital, LLC, Clinical Products, LLC, and Mountain Ventures, Inc. He serves on the Board of Mercy Ministries, Inc. and is past Chair of the Advisory Board of the College of Engineering, University of Tennessee. Mr. Cook retired as a Group Vice President of Eli Lilly & Company in 1993 after more than 28 years of service. Mr. Cook received a B.S. in Engineering from the University of Tennessee.

        Mr. Adams has served as a director since October 2007 and serves on the Compensation and Human Resources Committee. Mr. Adams is President and Chief Executive Officer of Sepracor, Inc., a position he has held since May 2007, and serves as a member of Sepracor's board of directors. Mr. Adams joined Sepracor in March 2007 as President and Chief Operating Officer. Most recently, he was with Kos Pharmaceuticals, Inc., where he served as President and Chief Operating Officer from April 2001, prior to becoming President and Chief Executive Officer in January 2002. Mr. Adams served as President and Chief Executive Officer of Novartis-UK from 1999 until his tenure began at Kos. For the previous seven years, he was with SmithKline Beecham Pharmaceuticals, last serving as President and CEO of the company's Canadian subsidiaries. Previous assignments at SmithKline Beecham included Vice President and Director of Worldwide Marketing in the U.S., and Director and Vice President of Sales and Marketing in the United Kingdom. Mr. Adams began his career at ICI Pharmaceuticals, where he rose from research laboratory assistant to Director of Sales and Marketing. He is a graduate of Manchester University in the United Kingdom with a Bachelor of Science degree.

        Mr. Altman has served as a director since March 2006 and serves on the Compensation and Human Resources Committee. He currently serves as President of QUALCOMM Incorporated, a position he has held since 2005. In 2002, Mr. Altman was named President of QUALCOMM Technology Licensing, or QTL, and previously served as QTL's Executive Vice President from 1998 to 2002 and as its Senior Vice President from 1996 to 1998. He became QTL's General Manager at the formation of the group in 1995. Mr. Altman joined QUALCOMM in 1989 as Corporate Counsel responsible for licensing and acquisitions and was appointed Vice President and General Counsel in 1992. He received his J.D. from the University of San Diego.

        Ms. Beck has served as a director since March 2007 and serves on the Audit Committee. From 1998 to 1999, Ms. Beck served as President of American Stores Company, and previously served as its Chief Financial Officer from 1993 to 1998. Prior to her appointment as Chief Financial Officer, Ms. Beck served in various finance and accounting related positions with American Stores from 1982 to 1993. Before joining American Stores, Ms. Beck was the controller of Steiner Financial Corporation and she served as an audit manager for Ernst & Whinney (currently Ernst and Young LLP). Ms. Beck currently serves as a director for Questar Corporation and Lexmark International, Inc. In addition, she serves as a member of the Board of Trustees of Intermountain Healthcare, The Nature Conservancy and the Nature Conservancy of Utah. She is also Vice-Chairman of the University of Utah National Advisory Council. Ms. Beck received a B.S. and an M.B.A. from the University of Utah.

        Ms. Eastham has served as a director since September 2005 and serves as the chair of the Audit Committee and on the Compensation and Human Resources Committee. From May 2004 to September 2008 she served as Executive Vice President and Chief Operating Officer, and as a member of the Board of Trustees of the Burnham Institute for Medical Research, a non-profit corporation engaged in basic biomedical research. From April 1999 to May 2004, Ms. Eastham served as Senior Vice President, Finance, Chief Financial Officer, and Secretary of Diversa Corporation. She previously held similar positions with CombiChem, Inc., a computational chemistry company, and Cytel Corporation, a biopharmaceutical company. Ms. Eastham also held several positions, including Vice

22


Table of Contents


President, Finance, at Boehringer Mannheim Corporation, from 1976 to 1988. Ms. Eastham also serves as a director for Illumina, Inc. and Genoptix, Inc. Ms. Eastham received a B.S. and an M.B.A. from Indiana University and is a Certified Public Accountant and a Certified Director.

        Dr. Gavin has served as a director since December 2005 and serves as chair of the Corporate Governance Committee. Dr. Gavin is CEO & Chief Medical Officer, Healing Our Village, Inc. He also serves as Clinical Professor of Medicine, Emory University School of Medicine and Clinical Professor of Medicine at the Indiana University School of Medicine. He was President of the Morehouse School of Medicine from 2002 to 2004. Dr. Gavin is a member of the board of directors of Baxter International Inc., and Anastasia Marie Laboratories, Inc. Dr. Gavin was Chairman of the board of directors of Equidyne Corporation from August 2001 to 2003. From 1991 to 2002, Dr. Gavin was a Senior Scientific Officer of the Howard Hughes Medical Institute. From 2002 until 2005, he served as National Chairman of the National Diabetes Education Program. He received his B.S. in Chemistry at Livingstone College, a Ph.D. in Biochemistry at Emory University and an M.D. at Duke University Medical School. Dr. Gavin has received numerous civic and academic awards and honors.

        Ms. Graham has served as a director since November 1995 and currently serves on the Finance Committee. Ms. Graham served as President and Chief Executive Officer from September 2003 until June 2006, serving as Chief Executive Officer from June 2006 until March 2007. Prior to joining us, Ms. Graham held various positions with Guidant Corporation, including Group Chairman; Office of the President; and President of the Vascular Intervention Group and Vice President. Ms. Graham held various positions with Eli Lilly and Company from 1979 to 1992 including sales, finance, marketing and strategic planning positions. She serves on the board of directors of Genomic Health, Inc., Sierra Neuropharmaceuticals, Inc., and ICAT Managers, LLC. She also serves on the American Diabetes Research Foundation Board, the California Council on Science and Technology Board, the Health Sciences Advisory Board for the University of California, San Diego, the Advisory Board for the Kellog Center for Executive Women and the Editorial Advisory Board for the Journal of Life Sciences. Ms. Graham received an M.B.A. from Harvard University.

        Mr. Greene is our co-founder and has served as a director since our inception in 1987. He serves on the Finance Committee. Mr. Greene is an entrepreneur who has participated in the founding and/or management of eleven medical technology companies over two decades, including three companies for which he served as chief executive officer. From 1987 to 1996, Mr. Greene served as our Chief Executive Officer. From 1986 until 1993, Mr. Greene was a founding general partner of Biovest Partners, a seed venture capital firm. He was Chief Executive Officer of Hybritech from 1979 until its acquisition by Eli Lilly and Company in 1986, and he was co-inventor of Hybritech's patented monoclonal antibody assay technology. Prior to joining Hybritech, he was an executive with the medical diagnostics division of Baxter Healthcare Corporation from 1974 to 1979 and a consultant with McKinsey & Company from 1967 to 1974. Mr. Greene received an M.B.A. from Harvard University.

        Dr. Skyler has served as a director since August 1999 and serves on the Corporate Governance Committee. He is Professor of Medicine, Pediatrics and Psychology, in the Division of Endocrinology Diabetes and Metabolism; and Associate Director for Academic Programs at the Diabetes Research Institute; all at the University of Miami Miller School of Medicine in Florida, where he has been employed since 1976. He is also Study Chairman for the National Institute of Diabetes & Digestive & Kidney Diseases of the Type 1 Diabetes TrialNet clinical trial network, and serves on the board of directors of DexCom, Inc., and various private companies. Dr. Skyler has served as President of the American Diabetes Association and as Vice President of the International Diabetes Federation. Dr. Skyler serves on the editorial board of several diabetes and general medicine journals and the advisory panel of several pharmaceutical companies. He received his B.S. from The Pennsylvania State University, his M.D. from Jefferson Medical College, and completed postdoctoral studies at Duke University Medical Center.

23


Table of Contents

        Mr. Sullivan has served as a director since September 2003 and serves on the Audit Committee and as chair of the Finance Committee. Mr. Sullivan is currently Chairman of the Board of Advisors of RAND Health and Chairman of the Board of Advisors of the UCLA Medical Center. From 2000 to 2003, Mr. Sullivan served as Chairman, Chief Executive Officer and a director of Protocare, Inc. From 1993 until November 1999, he served as Chairman, Chief Executive Officer and a director of American Health Properties, Inc. For the previous twenty years, Mr. Sullivan was an investment banker with Goldman Sachs. Mr. Sullivan currently serves on the board of directors of Cymetrix Corporation, HCP, Inc. (NYSE, a real estate investment trust) and AutoGenomics, Inc. Mr. Sullivan received his M.B.A. from the Harvard Graduate School of Business Administration and his J.D. from the University of Minnesota Law School.

        Mr. Wilson has served as a director since March 2002 and is our lead independent director. He serves as the chair of the Compensation and Human Resources Committee and on the Corporate Governance Committee. He is a director and Chairman of the Board of both Corcept Therapeutics Inc. and NuGEN, Inc. From 1996 to 2001, Mr. Wilson was Chairman of the Board of Amira Medical, Inc. From 1990 to 1994, Mr. Wilson served as President and Chief Operating Officer of Syntex Corporation. Prior to 1990, he served in various senior management positions, including Chief Executive Officer for Neurex Corporation and LifeScan, Inc. Mr. Wilson received his B.A. and M.B.A. from the University of Arizona.

        Mr. Eberhard has served as Vice President, Sales since May 2003. Prior to joining us, Mr. Eberhard was Regional Vice President, Sales, at Pharmacia Corporation, for which he had worked for 21 years. During his career with Pharmacia Corporation and its related pre-merger companies, he held positions in sales, sales management, corporate training, sales operations, and managed care before assuming the Vice President, Sales position. Mr. Eberhard received a B.S. in Biology from California Lutheran University.

        Mr. Foletta has served as Senior Vice President, Finance and Chief Financial Officer since March 2006 and he previously served as Vice President, Finance and Chief Financial Officer from March 2000 to March 2006. Mr. Foletta previously served as a Principal of Triton Group Management, Inc. from 1997 to 2000. From 1986 to 1997, Mr. Foletta held a number of management positions with Intermark, Inc. and Triton Group Ltd., the most recent of which was Senior Vice President, Chief Financial Officer and Corporate Secretary. From 1982 to 1986, Mr. Foletta was with Ernst & Young, most recently serving as an Audit Manager. He is a director of Anadys Pharmaceuticals, Inc. Mr. Foletta received a B.A. in Business Economics from the University of California, Santa Barbara. He is a Certified Public Accountant and a member of the Financial Executives Institute.

        Mr. Gergen has served as Senior Vice President, Corporate Development since August 2006 and previously served as Vice President of Business Development from May 2005 to August 2006. Prior to joining us, Mr. Gergen was an independent consultant to biotech and medical technology companies for strategy, financing and corporate development. From 2003 to 2005, Mr. Gergen was Executive Vice President at CardioNet, Inc. He held various positions at Advanced Tissue Sciences, Inc. from 2000 to 2003 most recently as Chief Restructuring Officer and Acting CEO. He also served as Senior Vice President, Chief Financial and Development Officer and Vice President, Development, General Counsel and Secretary. From 1999 to 2000, Mr. Gergen was employed at Premier, Inc. and from 1994 to 1999 he held various positions with Medtronic, Inc. From 1990 to 1994 he held various corporate development positions at Jostens, Inc. and from 1986 to 1990, he practiced law at various law firms. Mr. Gergen serves on the Board of Directors of a privately held company. Mr. Gergen received a B.A. in Administration from Minot State University and a J.D. from the University of Minnesota Law School.

        Dr. Kolterman has served as Senior Vice President, Research and Development since May 2008 and previously served as Senior Vice President, Clinical and Regulatory Affairs from 2005 to 2008. He

24


Table of Contents


also served as Senior Vice President, Clinical Affairs from February 1997 to August 2005, Vice President, Medical Affairs from 1993 to 1997, and Director, Medical Affairs from 1992 to 1993. From 1983 to 1992, he was Program Director of the General Clinical Research Center and Medical Director of the Diabetes Center, at the University of California, San Diego Medical Center. Since 1989, he has been Adjunct Professor of Medicine at the University of California, San Diego. From 1978 to 1983, he was Assistant Professor of Medicine in the Endocrinology and Metabolism Division at the University of Colorado School of Medicine, Denver. He was a member of the Diabetes Control and Complications Trial Study Group and presently serves as a member of the Epidemiology of Diabetes Intervention and Complications Study. He is also a past-president of the California Affiliate of the American Diabetes Association. Dr. Kolterman received his M.D. from Stanford University School of Medicine.

        Ms. Lloyd has served as our Senior Vice President, Legal and Corporate Affairs, and General Counsel since February 2007. Prior to joining us, Ms. Lloyd served as Group Senior Vice President, Chief Administrative Officer, General Counsel and Secretary of VHA Inc. from November 2004 to February 2007. Previously, she served as VHA's General Counsel and Secretary from May 1999 to November 2004. From 1993 to April 1999, Ms. Lloyd was Vice President and Assistant General Counsel of Medtronic, Inc. and served as Medtronic's Assistant General Counsel from 1991 to 1993. From 1978 to 1991, Ms. Lloyd held various legal positions with Medtronic. Prior to joining Medtronic, Ms. Lloyd served as counsel to Pillsbury Company and Montgomery Ward & Co. and she taught Business Law at the University of Minnesota Business School. Ms. Lloyd is a member of the board of the California Healthcare Institute and is an associate of the Women Business Leaders of the United States Health Care Industry Foundation. She received a B.S./B.A. from Knox College and a J.D. from Northwestern University.

        Mr. Marchetti has served as our Senior Vice President, Human Resources and Information Management since July 2007 and previously served as Senior Vice President, Human Resources and Corporate Services from November 2005 to July 2007. Prior to joining us, he served as Vice President, Human Resources for Guidant Corporation from July 2002 to October 2005. Prior to this role, he served as Vice President, Finance and Information Systems, Guidant Europe, Middle East, Africa, and Canada, since the beginning of 2001. From 1999 through 2000, he served as Vice President, Human Resources for Guidant's Vascular Intervention group, and served as Guidant's Corporate Controller and Chief Accounting Officer from 1994 to 1999. He joined Eli Lilly and Company's Medical Devices and Diagnostics division in 1988. In 1992, he became Financial Manager of Lilly's pharmaceutical manufacturing operations in Indianapolis. From 1980 to 1986, he was with Touche Ross & Co. (currently Deloitte). He received a B.S. from LaSalle University in Philadelphia and an M.B.A. from the Ross School of Business at the University of Michigan. He is a Certified Public Accountant.

        Mr. Marshall has served as Senior Vice President, Operations since December 2008. He previously served as Vice President Operations from December 2006 to December 2008. Prior to joining us, he was Vice President of Corporate Manufacturing at Amgen, Inc. From 2002 to 2005, Mr. Marshall served as President of Manufacturing at Recombinant Proteins at the Bioscience Division of Baxter International. From 1999 to 2002, he was Site Head of the Baxter International Thousand Oaks facility. He joined Creative BioMolecules in 1992, first as Head of Process Development and Clinical Manufacturing and then as Head of Operations. From 1988 to 1992, Mr. Marshall held various management positions with Welgen Manufacturing Partnership (now Amgen, Rhode Island), Repligen Corporation and Damon Biotech. Mr. Marshall received a B.S. and an M.S. in Biology from the University of Massachusetts at Dartmouth and completed three years of post-graduate work concentrating in hematology and coagulation research at Brown University.

        Mr. Mihalik has served as Senior Vice President, Sales and Marketing and Chief Commercial Officer since January 2009. Before joining us, Mr. Mihalik served as Vice President of Global Brand Development Diabetes and Endocrine Platform Team Leader for Lilly since 2004. Previously, he was Business Unit Head of Diabetes Care for Lilly U.S. from 2001 to 2004. From 1990 to 2001 he served in

25


Table of Contents


various senior management positions at other healthcare companies including Roche Diagnostics Corporation, Boehringer Mannheim Group and Baxter Healthcare Inc. He has a B.S. degree in Biology from Pennsylvania State University and completed the Northwestern University Masters in Management-Executive Program.

        Mr. Rowland has served as our Vice President, Governance and Compliance, Secretary, and Chief Compliance Officer since February 2007. He previously served as our Vice President, Legal, Secretary and General Counsel from September 2001 to February 2007. Prior to joining us, Mr. Rowland served in various positions at Alliance Pharmaceutical Corp., including as Vice President, General Counsel and Secretary, beginning in 1993. Earlier, Mr. Rowland served as Vice President and Senior Counsel, Finance and Securities, at Imperial Savings Association for four years. For the previous eight years, he was engaged in the private practice of corporate law with the San Diego, California law firm of Gray, Cary, Ames & Fry, and the Houston, Texas law firm of Bracewell & Patterson. He received a J.D. from Emory University.

Item 1A.    Risk Factors


CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS

        Except for the historical information contained herein or incorporated by reference, this annual report on Form 10-K and the information incorporated by reference contains forward-looking statements that involve risks and uncertainties. These statements include projections about our accounting and finances, plans and objectives for the future, future operating and economic performance and other statements regarding future performance. These statements are not guarantees of future performance or events. Our actual results may differ materially from those discussed here. Factors that could cause or contribute to differences in our actual results include those discussed in the following section, as well as those discussed in Part II, Item 7 entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere throughout this annual report on Form 10-K and in any other documents incorporated by reference into this report. You should consider carefully the following risk factors, together with all of the other information included or incorporated in this annual report on Form 10-K. Each of these risk factors, either alone or taken together, could adversely affect our business, operating results and financial condition, as well as adversely affect the value of an investment in our common stock. There may be additional risks that we do not presently know of or that we currently believe are immaterial which could also impair our business and financial position.

         We have a history of operating losses, anticipate future losses and may never become profitable.

        We have experienced significant operating losses since our inception in 1987, including losses of $315.4 million in 2008, $211.1 million in 2007 and $218.9 million in 2006. As of December 31, 2008, we had an accumulated deficit of approximately $1.7 billion. The extent of our future losses and the timing of potential profitability are uncertain, and we may never achieve profitable operations. We have been engaged in discovering and developing drugs since inception, which has required, and will continue to require, significant research and development expenditures. We derived substantially all of our revenues prior to 2005 from development funding, fees and milestone payments under collaborative agreements and from interest income. BYETTA and SYMLIN may not be as commercially successful as we expect and we may not succeed in commercializing any of our other drug candidates. We may incur substantial operating losses for at least the next few years. These losses, among other things, have had and will have an adverse effect on our stockholders' equity and working capital. Even if we become profitable, we may not remain profitable.

26


Table of Contents

         We began selling, marketing and distributing our first products, BYETTA and SYMLIN, in 2005 and we will depend heavily on the success of those products in the marketplace.

        Prior to the launch of BYETTA and SYMLIN in 2005, we had never sold or marketed our own products. Our ability to generate product revenue for the next few years will depend solely on the success of these products. The ability of BYETTA and SYMLIN to generate revenue at the levels we expect will depend on many factors, including the following:

    the ability of patients in the current uncertain economic climate to be able to afford our medications or obtain health care coverage that covers our products;

    acceptance of and ongoing satisfaction with these first-in-class medicines in the United States and foreign markets by the medical community, patients receiving therapy and third party payers;

    a satisfactory efficacy and safety profile as demonstrated in a broad patient population;

    successfully expanding and sustaining manufacturing capacity to meet demand;

    safety concerns in the marketplace for diabetes therapies;

    the competitive landscape for approved and developing therapies that will compete with the products; and

    our ability to expand the indications for which we can market the products.

         If we encounter safety issues with BYETTA or SYMLIN or any other drugs we market or fail to comply with extensive continuing regulations enforced by domestic and foreign regulatory authorities, it could cause us to discontinue marketing those drugs, reduce our revenues and harm our ability to generate future revenues, which would negatively impact our financial position.

        BYETTA and SYMLIN, in addition to any other of our drug candidates that may be approved by the FDA, will be subject to continual review by the FDA, and we cannot assure you that newly discovered or developed safety issues will not arise. With the use of any of our marketed drugs by a wide patient population, serious adverse events may occur from time to time that initially do not appear to relate to the drug itself, and only if the specific event occurs with some regularity over a period of time does the drug become suspect as having a causal relationship to the adverse event. Some patients taking BYETTA have reported developing pancreatitis. We are working to better understand the relationship between BYETTA and pancreatitis described in some spontaneously reported cases. In keeping with our focus on patient safety, we continue to pursue our drug safety program that includes thorough investigation of individual spontaneous case reports along with clinical and epidemiologic studies. Within the detection limits of an initial epidemiology study which we provided to the FDA, we have not observed an increased incidence of pancreatitis associated with BYETTA compared to other treatments for diabetes and thus believe a definite causal relationship between BYETTA and pancreatitis has not been proved. Any safety issues could cause us to suspend or cease marketing of our approved products, cause us to modify how we market our approved products, subject us to substantial liabilities, and adversely affect our revenues and financial condition.

        Moreover, the marketing of our approved products will be subject to extensive regulatory requirements administered by the FDA and other regulatory bodies, including adverse event reporting requirements and the FDA's general prohibition against promoting products for unapproved uses. The manufacturing facilities for our approved products are also subject to continual review and periodic inspection and approval of manufacturing modifications. Manufacturing facilities that manufacture drug products for the United States market, whether they are located inside or outside the United States, are subject to biennial inspections by the FDA and must comply with the FDA's current good manufacturing practice, or cGMP, regulations. The FDA stringently applies regulatory standards for manufacturing. Failure to comply with any of these post-approval requirements can, among other

27


Table of Contents


things, result in warning letters, product seizures, recalls, fines, injunctions, suspensions or revocations of marketing licenses, operating restrictions and criminal prosecutions. Any of these enforcement actions, any unanticipated changes in existing regulatory requirements or the adoption of new requirements, or any safety issues that arise with any approved products, could adversely affect our ability to market products and generate revenues and thus adversely affect our ability to continue our business.

        The manufacturers of our products and drug candidates also are subject to numerous federal, state, local and foreign laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control and hazardous substance disposal. In the future, our manufacturers may incur significant costs to comply with those laws and regulations, which could increase our manufacturing costs and reduce our ability to operate profitably.

         We currently do not manufacture our own drug products or some of our drug candidates and may not be able to obtain adequate supplies, which could cause delays, subject us to product shortages, or reduce product sales.

        The manufacturing of sufficient quantities of newly-approved drug products and drug candidates is a time-consuming and complex process. We currently have no manufacturing capabilities. In order to successfully commercialize our products, including BYETTA and SYMLIN, and continue to develop our drug candidates, including exenatide once weekly, we rely on various third parties to provide the necessary manufacturing.

        There are a limited number of manufacturers that operate under the FDA's cGMP regulations capable of manufacturing for us. In addition, there are a limited number of bulk drug substance suppliers, cartridge manufacturers and disposable pen manufacturers. If we are not able to arrange for and maintain third-party manufacturing on commercially reasonable terms, or we lose one of our sole source suppliers used for our existing products or for some components of our manufacturing processes for our products or drug candidates, we may not be able to market our products or complete development of our drug candidates on a timely basis, if at all.

        Reliance on third-party suppliers limits our ability to control certain aspects of the manufacturing process and therefore exposes us to a variety of significant risks, including, but not limited to, risks to our ability to commercialize our products or conduct clinical trials, risks of reliance on the third-party for regulatory compliance and quality assurance, third-party refusal to supply on a long-term basis, or at all, the possibility of breach of the manufacturing agreement by the third-party and the possibility of termination or non-renewal of the agreement by the third-party, based on its business priorities, at a time that is costly or inconvenient for us. In addition, reliance on single-source suppliers subjects us to the risk of price increases by these suppliers which could negatively impact our operating margins. If any of these risks occur, our product supply will be interrupted resulting in lost or delayed revenues and delayed clinical trials. Our reliance on third-party manufacturers for the production of our two commercial products is described in more detail below.

        We rely on Bachem and Mallinckrodt to manufacture our long-term commercial supply of bulk exenatide, the active ingredient in BYETTA. In addition, we rely on single-source manufacturers for some of our raw materials used by Bachem and Mallinckrodt to produce bulk exenatide. We also rely on Wockhardt and Baxter to manufacture the dosage form of BYETTA in cartridges. We are further dependent upon Lilly to supply pens for delivery of BYETTA in cartridges.

        We rely on Bachem and Lonza to manufacture our commercial supply of bulk pramlintide acetate, the active ingredient contained in SYMLIN. In addition, we rely on Baxter to manufacture the dosage form of SYMLIN in vials. We recently received FDA approval of a disposable pen for the delivery of SYMLIN in cartridges. We rely on Wockhardt for the dosage form of SYMLIN in cartridges and Ypsomed AG to manufacture the components for the SYMLIN disposable pen. We also rely on Hollister-Stier Laboratories LLC for the assembly of the SYMLIN pen.

28


Table of Contents

        If any of our existing or future manufacturers cease to manufacture or are otherwise unable to timely deliver sufficient quantities of BYETTA or SYMLIN, in either bulk or dosage form, or other product components, including pens for the delivery of these products, it could disrupt our ability to market our products, subject us to product shortages, reduce product sales and/or reduce our profit margins. Any delay or disruption in the manufacturing of bulk product, the dosage form of our products or other product components, including pens for delivery of our products, could also harm our reputation in the medical and patient communities. In addition, we may need to engage additional manufacturers so that we will be able to continue our commercialization and development efforts for these products or drug candidates. The cost and time to establish these new manufacturing facilities would be substantial.

        Our manufacturers have produced BYETTA and SYMLIN for commercial use for approximately four years, however, unforeseeable risks related to environmental, economic, technical or other issues may be encountered as we, together with our manufacturers, continue to develop familiarity and experience with regard to manufacturing our products. Furthermore, we and the other manufacturers used for our drug candidates may not be able to produce supplies in commercial quantities if our drug candidates are approved. While we believe that business relations between us and our manufacturers are generally good, we cannot predict whether any of the manufacturers that we may use will meet our requirements for quality, quantity or timeliness for the manufacture of bulk exenatide or pramlintide acetate, dosage form of BYETTA or SYMLIN, or pens. Therefore, we may not be able to obtain necessary supplies of products with acceptable quality, on acceptable terms or in sufficient quantities, if at all. Our dependence on third parties for the manufacture of products may also reduce our gross profit margins and our ability to develop and deliver products in a timely manner.

        In order to manufacture exenatide once weekly on a commercial scale, if it is approved by the FDA, we must complete construction of and commission a new facility and validate the manufacturing process. We are dependent on Alkermes and Parsons to assist us in the construction and commissioning of the manufacturing facility. We have never established, validated, and operated a manufacturing facility and cannot assure you that we will be able to successfully establish or operate such a facility in a timely or economical manner, or at all. In addition, we are dependent on Alkermes to successfully develop and transfer to us its technology for manufacturing exenatide once weekly and to supply us with commercial quantities of the polymer required to manufacture exenatide once weekly. We also will need to obtain sufficient supplies of diluents, solvents, devices, packaging and other components necessary for commercial manufacture of exenatide once weekly. Although we are working diligently to qualify the commercial-scale manufacturing process at this facility, we cannot be assured that we will be able to demonstrate comparability of product manufactured at development scale and product manufactured at commercial scale. If we are unable to demonstrate comparability of product, we may not be able to commercially launch exenatide once weekly in a timely manner or at all.

         Our ability to generate revenues will be diminished if we fail to obtain acceptable prices or an adequate level of reimbursement for our products from third-party payers.

        The continuing efforts of government, private health insurers and other third-party payers to contain or reduce the costs of health care through various means, including efforts to increase the amount of patient co-pay obligations, may limit our commercial opportunity. In the United States, we expect that there will continue to be a number of federal and state proposals to implement government control over the pricing of prescription pharmaceuticals. In addition, increasing emphasis on managed care in the United States will continue to put pressure on the rate of adoption and pricing of pharmaceutical products.

        Significant uncertainty exists as to the reimbursement status of health care products. Third-party payers, including Medicare, are challenging the prices charged for medical products and services. Government and other third-party payers increasingly are attempting to contain health care costs by

29


Table of Contents


limiting both coverage and the level of reimbursement for new drugs and by refusing to provide coverage for uses of approved products for disease indications for which the FDA has not granted labeling approval. Third-party insurance coverage may not be available to patients for BYETTA and/or SYMLIN or any other products we discover and develop. If government and other third-party payers do not provide adequate coverage and reimbursement levels for our products, the market acceptance of these products may be reduced.

         Competition in the biotechnology and pharmaceutical industries may result in competing products, superior marketing of other products and lower revenues or profits for us.

        There are many companies that are seeking to develop products and therapies for the treatment of diabetes and other metabolic disorders. Our competitors include multinational pharmaceutical and chemical companies, specialized biotechnology firms and universities and other research institutions. A number of our largest competitors, including AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Merck & Co., Novartis, Novo Nordisk, Pfizer, Sanofi-Aventis and Takeda Pharmaceuticals, are pursuing the development or marketing of pharmaceuticals that target the same diseases that we are targeting, and it is possible that the number of companies seeking to develop products and therapies for the treatment of diabetes, obesity and other metabolic disorders will increase. Many of our competitors have substantially greater financial, technical, human and other resources than we do and may be better equipped to develop, manufacture and market technologically superior products. In addition, many of these competitors have significantly greater experience than we do in undertaking preclinical testing and human clinical studies of new pharmaceutical products and in obtaining regulatory approvals of human therapeutic products. Accordingly, our competitors may succeed in obtaining FDA approval for superior products. Furthermore, now that we have received FDA approval for BYETTA and SYMLIN, we may also be competing against other companies with respect to our manufacturing and product distribution efficiency and sales and marketing capabilities, areas in which we have limited or no experience as an organization.

        Our target patient population for BYETTA includes people with diabetes who have not achieved adequate glycemic control using metformin, sulfonylurea and/or a TZD, three common oral therapies for type 2 diabetes. Our target population for SYMLIN is people with either type 2 or type 1 diabetes whose therapy includes multiple mealtime insulin injections daily. Other products are currently in development or exist in the market that may compete directly with the products that we are developing or marketing. Various other products are available or in development to treat type 2 diabetes, including:

    sulfonylureas;

    metformin;

    insulins, including injectable and inhaled versions;

    TZDs;

    glinides;

    DPP-IV inhibitors;

    incretin/GLP-1 agonists;

    PPARs; and

    alpha-glucosidase inhibitors.

        In addition, several companies are developing various approaches, including alternative delivery methods, to improve treatments for type 1 and type 2 diabetes. We cannot predict whether our products will have sufficient advantages to cause health care professionals to adopt them over other products or that our products will offer an economically feasible alternative to other products. Our products could become obsolete before we recover expenses incurred in developing these products.

30


Table of Contents

         Delays in the conduct or completion of our clinical trials, the analysis of the data from our clinical trials or our manufacturing scale-up activities may result in delays in our planned filings for regulatory approvals, and may adversely affect our ability to enter into new collaborative arrangements.

        We cannot predict whether we will encounter problems with any of our completed, ongoing or planned clinical studies that will cause us to delay or suspend our ongoing and planned clinical studies, delay the analysis of data from our completed or ongoing clinical studies or perform additional clinical studies prior to receiving necessary regulatory approvals. We also cannot predict whether we will encounter delays or an inability to create manufacturing processes for drug candidates that allow us to produce drug product in sufficient quantities to be economical, otherwise known as manufacturing scale-up.

        If the results of our ongoing or planned clinical studies for our drug candidates are not available when we expect or if we encounter any delay in the analysis of data from our clinical studies or if we encounter delays in our ability to scale-up our manufacturing processes:

    we may be unable to complete our development programs for exenatide once weekly or our obesity clinical trials;

    we may have to delay or terminate our planned filings for regulatory approval;

    we may not have the financial resources to continue research and development of any of our drug candidates; and

    we may not be able to enter into, if we chose to do so, any additional collaborative arrangements.

        In addition, Lilly can terminate our collaboration for the development and commercialization of BYETTA and sustained-release formulations of exenatide at any time on six months' notice.

        Any of the following could delay the completion of our ongoing and planned clinical studies:

    ongoing discussions with the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;

    delays in enrolling volunteers;

    lower than anticipated retention rate of volunteers in a clinical trial;

    negative results of clinical studies;

    insufficient supply or deficient quality of drug candidate materials or other materials necessary for the performance of clinical trials;

    our inability to reach agreement with Lilly regarding the scope, design, conduct or costs of clinical trials with respect to BYETTA, exenatide once weekly or nasal exenatide; or

    serious side effects experienced by study participants relating to a drug candidate.

         We are substantially dependent on our collaboration with Lilly for the development and commercialization of BYETTA and dependent on Lilly and Alkermes for the development of exenatide once weekly.

        We have entered into a collaborative arrangement with Lilly, who currently markets diabetes therapies and is developing additional diabetes drug candidates, to commercialize BYETTA and further develop sustained-release formulations of BYETTA, including exenatide once weekly. We entered into this collaboration in order to:

    fund some of our research and development activities;

    assist us in seeking and obtaining regulatory approvals; and

31


Table of Contents

    assist us in the successful commercialization of BYETTA and exenatide once weekly.

        In general, we cannot control the amount and timing of resources that Lilly may devote to our collaboration. If Lilly fails to assist in the further development of exenatide once weekly or the commercialization of BYETTA, or if Lilly's efforts are not effective, our business may be negatively affected. We are relying on Lilly to obtain regulatory approvals for and successfully commercialize BYETTA and exenatide once weekly outside the United States. Our collaboration with Lilly may not continue or result in additional successfully commercialized drugs. Lilly can terminate our collaboration at any time upon six months' notice. If Lilly ceased funding and/or developing and commercializing BYETTA or exenatide once weekly, we would have to seek additional sources for funding and may have to delay, reduce or eliminate one or more of our commercialization and development programs for these compounds. If Lilly does not successfully commercialize BYETTA outside the United States we may receive limited or no revenues from them. In addition, we are dependent on Alkermes to successfully develop and transfer to us its technology for manufacturing exenatide once weekly. If Alkermes' technology is not successfully developed to effectively deliver exenatide in a sustained release formulation, or Alkermes does not devote sufficient resources to the collaboration, our efforts to develop sustained release formulations of exenatide could be delayed or curtailed.

         If our patents are determined to be unenforceable or if we are unable to obtain new patents based on current patent applications or for future inventions, we may not be able to prevent others from using our intellectual property. If we are unable to obtain licenses to third party patent rights for required technologies, we could be adversely affected.

        We own or hold exclusive rights to many issued United States patents and pending United States patent applications related to the development and commercialization of exenatide, including BYETTA and exenatide once weekly, SYMLIN and our other drug candidates. These patents and applications cover composition-of-matter, medical indications, methods of use, formulations and other inventive results. We have issued and pending applications for formulations of BYETTA and exenatide once weekly, but we do not have a composition-of-matter patent covering exenatide. We also own or hold exclusive rights to various foreign patent applications that correspond to issued United States patents or pending United States patent applications.

        Our success will depend in part on our ability to obtain patent protection for our products and drug candidates and technologies both in the United States and other countries. We cannot guarantee that any patents will issue from any pending or future patent applications owned by or licensed to us. Alternatively, a third party may successfully challenge or circumvent our patents. Our rights under any issued patents may not provide us with sufficient protection against competitive products or otherwise cover commercially valuable products or processes. For example, our SYMLIN and BYETTA products are subject to the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the "Hatch-Waxman Act," which provides data exclusivity for a certain period of time. Once this exclusivity period expires, the Hatch-Waxman Act allows generic manufacturers to file Abbreviated New Drug Applications, or ANDAs, with the FDA requesting approval of generic versions of previously-approved products. For example, a generic pharmaceutical manufacturer could file an ANDA for SYMLIN as early as March 2009 and for BYETTA as early as April 2009. If an ANDA is filed for one of our approved products prior to expiration of the patents covering those products, it could result in our initiating patent infringement litigation to enforce our rights. We can provide no assurances that we would prevail in such an action or in any challenge related to our patent rights.

        In addition, because patent applications in the United States are maintained, in general, in secrecy for 18 months after the filing of the applications, and publication of discoveries in the scientific or patent literature often lag behind actual discoveries, we cannot be sure that the inventors of subject matter covered by our patents and patent applications were the first to invent or the first to file patent applications for these inventions. Third parties have filed, and in the future are likely to file, patent

32


Table of Contents


applications on inventions similar to ours. From time-to-time we have participated in, and in the future are likely to participate in, interference proceedings declared by the United States Patent and Trademark Office to determine priority of invention, which could result in a loss of our patent position. We have also participated in, and in the future are likely to participate in, opposition proceedings against our patents in other jurisdictions, such as Europe and Australia. Furthermore, we may not have identified all United States and foreign patents that pose a risk of infringement.

        We also rely upon licensing opportunities for some of our technologies. We cannot be certain that we will not lose our rights to certain patented technologies under existing licenses or that we will be able to obtain a license to any required third-party technology. If we lose our licensed technology rights or if we are not able to obtain a required license, we could be adversely affected.

         We may be unable to obtain regulatory clearance to market our drug candidates in the United States or foreign countries on a timely basis, or at all.

        Our drug candidates are subject to extensive government regulations related to development, clinical trials, manufacturing and commercialization. The process of obtaining FDA and other regulatory approvals is costly, time-consuming, uncertain and subject to unanticipated delays. Regulatory authorities may refuse to approve an application for approval of a drug candidate if they believe that applicable regulatory criteria are not satisfied. Regulatory authorities may also require additional testing for safety and efficacy. Moreover, if the FDA grants regulatory approval of a product, the approval may be limited to specific indications or limited with respect to its distribution, and expanded or additional indications for approved drugs may not be approved, which could limit our revenues. Foreign regulatory authorities may apply similar limitations or may refuse to grant any approval. Unexpected changes to the FDA or foreign regulatory approval process could also delay or prevent the approval of our drug candidates.

        The data collected from our clinical trials may not be sufficient to support approval of our drug candidates or additional or expanded indications by the FDA or any foreign regulatory authorities. Biotechnology stock prices have declined significantly in certain instances where companies have failed to meet expectations with respect to FDA approval or the timing for FDA approval. If the FDA's or any foreign regulatory authority's response is delayed or not favorable for any of our drug candidates, our stock price could decline significantly.

        Moreover, manufacturing facilities operated by us or by the third-party manufacturers with whom we may contract to manufacture our unapproved drug candidates may not pass an FDA or other regulatory authority preapproval inspection. Any failure or delay in obtaining these approvals could prohibit or delay us or any of our business partners from marketing these drug candidates.

        Consequently, even if we believe that preclinical and clinical data are sufficient to support regulatory approval for our drug candidates, the FDA and foreign regulatory authorities may not ultimately approve our drug candidates for commercial sale in any jurisdiction. If our drug candidates are not approved, our ability to generate revenues may be limited and our business will be adversely affected.

         Litigation regarding patents and other proprietary rights may be expensive, cause delays in bringing products to market and harm our ability to operate.

        Our success will depend in part on our ability to operate without infringing the proprietary rights of third parties and preventing others from infringing our patents. Challenges by pharmaceutical companies against the patents of competitors are common. Legal standards relating to the validity of patents covering pharmaceutical and biotechnological inventions and the scope of claims made under these patents are still developing. As a result, our ability to obtain and enforce patents is uncertain and involves complex legal and factual questions. Third parties may challenge, in courts or through patent

33


Table of Contents


office proceedings, or infringe upon, existing or future patents. In the event that a third party challenges a patent, a court or patent office may invalidate the patent or determine that the patent is not enforceable. Proceedings involving our patents or patent applications or those of others could result in adverse decisions about:

    the patentability of our inventions, products and drug candidates; and/or

    the enforceability, validity or scope of protection offered by our patents.

        The manufacture, use or sale of any of our products or drug candidates may infringe on the patent rights of others. If we are unable to avoid infringement of the patent rights of others, we may be required to seek a license, defend an infringement action or challenge the validity of the patents in court. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion. In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to successfully defend an infringement action or have infringing patents declared invalid, we may:

    incur substantial monetary damages;

    encounter significant delays in bringing our drug candidates to market; and/or

    be precluded from participating in the manufacture, use or sale of our products or drug candidates or methods of treatment requiring licenses.

         We are subject to "fraud and abuse" and similar laws and regulations, and a failure to comply with such regulations or prevail in any litigation related to noncompliance could harm our business.

        Upon approval of BYETTA and SYMLIN by the FDA, we became subject to various health care "fraud and abuse" laws, such as the Federal False Claims Act, the federal anti-kickback statute and other state and federal laws and regulations. Pharmaceutical companies have faced lawsuits and investigations pertaining to violations of these laws and regulations. We cannot guarantee that measures that we have taken to prevent such violations, including our corporate compliance program, will protect us from future violations, lawsuits or investigations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

         Our financial results will fluctuate, and these fluctuations may cause our stock price to fall.

        Forecasting future revenues is difficult, especially since we launched our first products in 2005 and the level of market acceptance of these products may change rapidly. In addition, our customer base is highly concentrated with four customers accounting for most of our net product sales. Fluctuations in the buying patterns of these customers, which may result from seasonality, wholesaler buying decisions or other factors outside of our control, could significantly affect the level of our net sales on a period to period basis. As a result, it is reasonably likely that our financial results will fluctuate to an extent that may not meet with market expectations and that also may adversely affect our stock price. There are a number of other factors that could cause our financial results to fluctuate unexpectedly, including:

    product sales;

    cost of product sales;

    achievement and timing of research and development milestones;

    collaboration revenues;

    cost and timing of clinical trials, regulatory approvals and product launches;

    marketing and other expenses;

34


Table of Contents

    manufacturing or supply issues; and

    potential acquisitions of businesses and technologies and our ability to successfully integrate any such acquisitions into our existing business.

         We may require additional financing in the future, which may not be available to us on favorable terms, or at all.

        We intend to use our available cash for:

    Commercialization of BYETTA and SYMLIN;

    Establishment of additional manufacturing sources, including our Ohio manufacturing facility;

    Development of exenatide once weekly and other pipeline candidates;

    Executing our INTO strategy;

    Our other research and development activities;

    Other operating expenses;

    Potential acquisitions or investments in complementary technologies or businesses; and

    Other general corporate purposes.

        We may also be required to use our cash to pay principal and interest on outstanding debt, including a $125 million term loan due in 2010, referred to as the Term Loan, and $775 million in outstanding principal amount of convertible senior notes, of which $200 million is due in 2011, referred to as the 2004 Notes and $575 million is due in 2014, referred to as the 2007 Notes.

        If we require additional financing in the future, we cannot assure you that it will be available to us on favorable terms, or at all. Although we have previously been successful in obtaining financing through our debt and equity securities offerings, there can be no assurance that we will be able to so in the future, especially given the current adverse economic and credit conditions.

         Our investments in marketable debt securities are subject to credit and market risks that may adversely affect their fair value.

        We maintain a portfolio of investments in marketable debt securities which are recorded at fair value. Although we have established investment guidelines relative to diversification and maturity with the objective of maintaining safety of principal and liquidity, credit rating agencies may reduce the credit quality of our individual holdings which could adversely affect their value. Lower credit quality and other market events, such as increases in interest rates, and further deterioration in the credit markets may have an adverse effect on the fair value of our investment holdings and cash position.

         Our business has a substantial risk of product liability claims, and insurance may not be adequate to cover these claims.

        Our business exposes us to potential product liability risks that are inherent in the testing, manufacturing and marketing of human therapeutic products. For example, we are currently involved in seven product liability cases, four of which have been stayed pending the U.S. Supreme Court's decision on federal preemption of such cases in Wyeth v. Levine. We have also been notified of additional claimants who may file product liability complaints. Product liability claims could result in the imposition of substantial defense costs and liability on us, a recall of products, or a change in the indications for which they may be used. We currently have limited product liability insurance coverage. We cannot assure you that our insurance will provide adequate coverage against potential liabilities.

35


Table of Contents


         Our ability to enter into and maintain third-party relationships is important to our successful development and commercialization of BYETTA, SYMLIN and our other drug candidates and to our potential profitability.

        With respect to sales, marketing and distribution outside the United States, we will be substantially dependent on Lilly for activities relating to BYETTA and sustained-release formulations of BYETTA, including exenatide once weekly. We believe that we will likely need to enter into marketing and distribution arrangements with third parties for, or find a corporate partner who can provide support for, the development and commercialization of SYMLIN or our other drug candidates outside the United States. We may also enter into arrangements with third parties for the commercialization of SYMLIN or any of our other drug candidates within the United States.

        With respect to BYETTA and, if approved, exenatide once weekly, Lilly is co-promoting within the United States. If Lilly ceased commercializing BYETTA or, if approved, exenatide once weekly, for any reason, we would likely need to either enter into a marketing and distribution arrangement with a third party for those products or significantly increase our internal sales and commercialization infrastructure.

        We may not be able to enter into marketing and distribution arrangements or find a corporate partner for SYMLIN or our other drug candidates as we deem necessary. If we are not able to enter into a marketing or distribution arrangement or find a corporate partner who can provide support for commercialization of our drug candidates as we deem necessary, we may not be able to successfully perform these marketing or distribution activities. Moreover, any new marketer or distributor or corporate partner for our drug candidates, including Lilly, with whom we choose to contract may not establish adequate sales and distribution capabilities or gain market acceptance for our products, if any.

         We have a significant amount of indebtedness. We may not be able to make payments on our indebtedness, and we may incur additional indebtedness in the future, which could adversely affect our operations.

        In April 2004, we issued $200 million of the 2004 Notes and in June 2007, we issued $575 million of the 2007 Notes. In December 2007, we entered into the $125 million Term Loan due in December 2010. Our ability to make payments on our debt, including the 2004 and 2007 Notes and the Term Loan, will depend on our future operating performance and ability to generate cash and may also depend on our ability to obtain additional debt or equity financing. During each of the last five years, our operating cash flows were negative and insufficient to cover our fixed charges. We may need to use our cash to pay principal and interest on our debt, thereby reducing the funds available to fund our research and development programs, strategic initiatives and working capital requirements. Our ability to generate sufficient operating cash flow to service our indebtedness, including the 2004 and 2007 Notes and the Term Loan, and fund our operating requirements will depend on our ability, alone or with others, to successfully develop, manufacture, obtain required regulatory approvals for and market our drug candidates, as well as other factors, including general economic, financial, competitive, legislative and regulatory conditions, some of which are beyond our control. Our debt service obligations increase our vulnerabilities to competitive pressures, because many of our competitors are less leveraged than we are. If we are unable to generate sufficient operating cash flow to service our indebtedness and fund our operating requirements, we may be forced to reduce or defer our development programs, sell assets or seek additional debt or equity financing, which may not be available to us on satisfactory terms or at all. Our level of indebtedness may make us more vulnerable to economic or industry downturns. If we incur new indebtedness, the risks relating to our business and our ability to service our indebtedness will intensify.

36


Table of Contents


         We may be required to redeem our convertible senior notes upon a designated event or repay the Term Loan upon an event of default.

        Holders of the 2004 and 2007 Notes may require us to redeem all or any portion of their notes upon the occurrence of certain designated events which generally involve a change in control of our company. The lenders under the Term Loan may require us to repay outstanding principal and accrued interest due under the Term Loan upon the occurrence of an event of default, which could include, among other things, nonpayment of principle and interest, violation of covenants and a change in control. We recently received notices from each of Icahn Partners LP and certain of its affiliates (the "Icahn Group") and Eastbourne Capital Management, L.L.C. ("Eastbourne") and certain of its affiliates, announcing their intent to each nominate five individuals for election to our Board of Directors at the 2009 annual meeting and, in the case of the Icahn Group, to submit a proposal for shareholder approval requesting that we reincorporate in the state of North Dakota. If as a result of this potential proxy contest a majority of our Board of Directors ceases to be composed of the existing directors or other individuals approved by a majority of the existing directors, then a "change of control" under the Term Loan and a "fundamental change" under the indenture for 2007 Notes will be triggered. If triggered, the lenders under the Term Loan may terminate their commitments and accelerate our outstanding debt and the holders of our 2007 Notes may require us to repurchase the notes. We may not have the liquidity or financial resources to do so at the times required or at all.

        We may not have sufficient cash funds to redeem the notes upon a designated event or repay the Term Loan upon an event of default. We may elect, subject to certain conditions, to pay the redemption price for the 2004 Notes in our common stock or a combination of cash and our common stock. We may be unable to satisfy the requisite conditions to enable us to pay some or all of the redemption price for the 2004 Notes in our common stock. If we are prohibited from redeeming the 2004 or 2007 Notes, we could seek consent from our lenders to redeem the 2004 or 2007 notes. If we are unable to obtain their consent, we could attempt to refinance the 2004 or 2007 Notes. If we were unable to obtain a consent or refinance, we would be prohibited from redeeming the 2004 or 2007 Notes. If we were unable to redeem the 2004 or 2007 Notes upon a designated event, it would result in an event of default under the indentures governing the 2004 or 2007 Notes. An event of default under the indentures could result in a further event of default under our other then-existing debt, including the Term Loan. In addition, the occurrence of a designated event may be an event of default under our other debt. Further, an event of default under the Term Loan could result in an event of default under the indentures governing the 2004 or 2007 Notes.

         If our research and development programs fail to result in additional drug candidates, the growth of our business could be impaired.

        Certain of our research and development programs for drug candidates are at an early stage and will require significant research, development, preclinical and clinical testing, manufacturing scale-up activities, regulatory approval and/or commitments of resources before commercialization. We cannot predict whether our research will lead to the discovery of any additional drug candidates that could generate additional revenues for us.

         Our future success depends on our chief executive officer, and other key executives and our ability to attract, retain and motivate qualified personnel.

        We are highly dependent on our chief executive officer, and the other principal members of our executive and scientific teams. The unexpected loss of the services of any of these persons might impede the achievement of our research, development and commercialization objectives. Recruiting and retaining qualified sales, marketing, regulatory, scientific and other personnel and consultants will also be critical to our success. We may not be able to attract and retain these personnel and consultants on

37


Table of Contents


acceptable terms given the competition between numerous pharmaceutical and biotechnology companies. We do not maintain "key person" insurance on any of our employees.

         We may be unable to adequately prevent disclosure of trade secrets and other proprietary information.

        In order to protect our proprietary technology and processes, we rely in part on confidentiality agreements with our corporate partners, employees, consultants, manufacturers, outside scientific collaborators and sponsored researchers and other advisors. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover our trade secrets and proprietary information.

        Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.

         Our research and development activities and planned manufacturing activities involve the use of hazardous materials, which subject us to regulation, related costs and delays and potential liabilities.

        Our research and development and our planned manufacturing activities involve the controlled use of hazardous materials, chemicals and various radioactive compounds. Although we believe that our research and development safety procedures for handling and disposing of these materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be eliminated. In addition, as part of the development of our planned manufacturing activities, we will need to develop additional safety procedures for the handling and disposing of hazardous materials. If an accident occurs, we could be held liable for resulting damages, which could be substantial. We are also subject to numerous environmental, health and workplace safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and the handling of biohazardous materials. Additional federal, state and local laws and regulations affecting our operations may be adopted in the future. We may incur substantial costs to comply with, and substantial fines or penalties if we violate any of these laws or regulations.

         We are exposed to potential risks from legislation requiring companies to evaluate internal control over financial reporting.

        The Sarbanes-Oxley Act requires that we report annually on the effectiveness of our internal control over financial reporting. Among other things, we must perform systems and processes evaluation and testing. We must also conduct an assessment of our internal control to allow management to report on, and our independent registered public accounting firm to attest to, our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act. In connection with our Section 404 compliance efforts, we have incurred or expended, and expect to continue to incur or expend, substantial accounting and other expenses and significant management time and resources. We have implemented certain remediation activities resulting from our ongoing assessment of internal control over financial reporting. Our future assessment, or the future assessments by our independent registered public accounting firm, may reveal material weaknesses in our internal control. If material weaknesses are identified in the future we would be required to conclude that our internal control over financial reporting are ineffective and we could be subject to sanctions or investigations by the SEC, the NASDAQ Stock Market or other regulatory authorities, which would require additional financial and management resources and could adversely affect the market price of our common stock.

38


Table of Contents


         We have implemented anti-takeover provisions that could discourage or prevent an acquisition of our company, even if the acquisition would be beneficial to our stockholders, and as a result our management may become entrenched and hard to replace.

        Provisions in our certificate of incorporation and bylaws could make it more difficult for a third party to acquire us, even if doing so would benefit our stockholders. These provisions include:

    allowing our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors;

    allowing our board of directors to issue, without stockholder approval, up to 5.5 million shares of preferred stock with terms set by the board of directors;

    limiting the ability of holders of our outstanding common stock to call a special meeting of our stockholders; and

    preventing stockholders from taking actions by written consent and requiring all stockholder actions to be taken at a meeting of our stockholders.

        Each of these provisions, as well as selected provisions of Delaware law, could discourage potential takeover attempts, could adversely affect the trading price of our securities and could cause our management to become entrenched and hard to replace. In addition to provisions in our charter documents and under Delaware law, an acquisition of our company could be made more difficult by our employee benefits plans and our employee change in control severance plan, under which, in connection with a change in control and termination of employment, stock options held by our employees may become vested and our officers may receive severance benefits. We also have implemented a stockholder rights plan, also called a poison pill, which could make it uneconomical for a third party to acquire us on a hostile basis.

         Our executive officers, directors and major stockholders control approximately 66% of our common stock.

        As of December 31, 2008, executive officers, directors and holders of 5% or more of our outstanding common stock, in the aggregate, owned or controlled approximately 66% of our outstanding common stock. As a result, these stockholders are able to influence all matters requiring approval by our stockholders, including the election of directors and the approval of corporate transactions. This concentration of ownership may also delay, deter or prevent a change in control of our company and may make some transactions more difficult or impossible to complete without the support of these stockholders.

         We could be negatively affected as a result of a threatened proxy fight and other actions of activist shareholders

        If a proxy contest results from one or both notices received from the Icahn Group or Eastbourne announcing their intent to each nominate five individuals for election to our Board of Directors at the 2009 annual meeting and, in the case of the Icahn Group, to submit a proposal for shareholder approval requesting that we reincorporate in the state of North Dakota, our business could be adversely affected because:

    responding to proxy contests and other actions by activist stockholders can be costly and time-consuming, disrupting our operations and diverting the attention of management and our employees;

    if a majority of our Board of Directors ceases to be composed of the existing directors or other individuals approved by a majority of the existing directors, we may be required to repay $575 million under our 2007 Notes, $125 million under our Term Loan and any amounts that

39


Table of Contents

      may be outstanding under our $15 million revolving credit facility, and if a cross-default is triggered, $200 million under our 2004 Notes;

    perceived uncertainties as to our future direction may impact our existing and potential collaborations or strategic relationships and in-licensing opportunities and may make it more difficult to attract and retain qualified personnel; and

    if individuals are elected to our Board of Directors with a specific agenda, it may adversely affect our ability to effectively and timely implement our strategic plan.

         Substantial future sales of our common stock by us or our existing stockholders or the conversion of our convertible senior notes to common stock could cause the trading price of our common stock to fall.

        Sales by existing stockholders of a large number of shares of our common stock in the public market or the perception that additional sales could occur could cause the trading price of our common stock to drop. Likewise, the issuance of shares of common stock upon conversion of our convertible notes or redemption of our convertible notes upon a designated event, or upon additional convertible debt or equity financings or other share issuances by us, including shares issued in connection with potential future strategic alliances, could adversely affect the trading price of our common stock. Our convertible notes are currently convertible into a total of up to 15.2 million shares. In addition, the existence of these notes may encourage short selling of our common stock by market participants.

         Significant volatility in the market price for our common stock could expose us to litigation risk.

        The market prices for securities of biopharmaceutical and biotechnology companies, including our common stock, have historically been highly volatile, and the market from time to time has experienced significant price and volume fluctuations that are unrelated to the quarterly operating performance of these biopharmaceutical and biotechnology companies. Since January 1, 2007, the high and low sales price of our common stock varied significantly, as shown in the following table:

 
  High   Low  

Year ending December 31, 2009

             

First Quarter (through February 10, 2009)

  $ 14.13   $ 10.16  

Year ending December 31, 2008

             

Fourth Quarter

  $ 20.47   $ 5.50  

Third Quarter

  $ 35.00   $ 18.55  

Second Quarter

  $ 33.22   $ 25.30  

First Quarter

  $ 37.38   $ 23.75  

Year ended December 31, 2007

             

Fourth Quarter

  $ 51.10   $ 35.83  

Third Quarter

  $ 53.25   $ 40.86  

Second Quarter

  $ 46.93   $ 36.91  

First Quarter

  $ 42.45   $ 35.55  

        Given the uncertainty of our future funding, whether BYETTA and SYMLIN will meet our expectations, and the regulatory approval of our other drug candidates, we may continue to experience volatility in our stock price for the foreseeable future. In addition, the following factors may significantly affect the market price of our common stock:

    our financial results and/or fluctuations in our financial results;

    safety issues with BYETTA, SYMLIN or our product candidates;

    clinical study results;

40


Table of Contents

    determinations by regulatory authorities with respect to our drug candidates;

    our ability to complete our Ohio manufacturing facility and the commercial manufacturing process for exenatide once weekly;

    developments in our relationships with current or future collaborative partners;

    our ability to successfully execute our commercialization strategies;

    developments in our relationships with third-party manufacturers of our products and other parties who provide services to us;

    technological innovations or new commercial therapeutic products by us or our competitors;

    developments in patent or other proprietary rights; and

    governmental policy or regulation, including with respect to pricing and reimbursement.

Broad market and industry factors also may materially adversely affect the market price of our common stock, regardless of our actual operating performance. Periods of volatility in the market price of our common stock expose us to securities class-action litigation, and we may be the target of such litigation as a result of market price volatility in the future.

Item 1B.    Unresolved Staff Comments

        None.

Item 2.    Properties

        Our primary administrative offices and research laboratories are located in San Diego, California. As of December 31, 2008, we had leases for approximately 830,000 square feet of office and laboratory space. Our leases on a majority of these properties expire between 2015 and 2019. We have also entered into short-term leases and other agreements for small offices in Beachwood, Ohio, Laguna Niguel, California and Washington, D.C.

        Our wholly-owned subsidiary, Amylin Ohio LLC, owns two buildings and 44.4 acres of land in West Chester, Ohio. The buildings, once built out for the manufacture of exenatide once weekly, will have approximately 565,000 square feet of manufacturing and office space.

Item 3.    Legal Proceedings

        From time-to-time we become involved in various lawsuits, claims and proceedings relating to the conduct of our business, including those pertaining to product liability, patent infringement and employment claims. For example, we are currently involved in seven product liability cases, four of which have been stayed pending the U.S Supreme Court's decision on federal preemption of such cases in Wyeth v. Levine. We have also been notified of additional claimants who may file product liability complaints. While we cannot predict the outcome of any lawsuit, claim or proceeding, we believe the disposition of the current lawsuits is not likely to have a material effect on our financial condition or liquidity.

Item 4.    Submission of Matters to a Vote of Security Holders

        None.

41


Table of Contents


PART II

Item 5.    Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

        Our common stock is traded on The NASDAQ Global Market under the symbol "AMLN." The following table sets forth, for the periods indicated, the reported high and low sales price per share of our common stock on The NASDAQ Global Market:

 
  High   Low  

Year Ended December 31, 2008

             

Fourth Quarter

  $ 20.47   $ 5.50  

Third Quarter

  $ 35.00   $ 18.55  

Second Quarter

  $ 33.22   $ 25.30  

First Quarter

  $ 37.38   $ 23.75  

Year Ended December 31, 2007

             

Fourth Quarter

  $ 51.10   $ 35.83  

Third Quarter

  $ 53.25   $ 40.86  

Second Quarter

  $ 46.93   $ 36.91  

First Quarter

  $ 42.45   $ 35.55  

        The last reported sale price of our common stock on The NASDAQ Global Market on February 10, 2009 was $13.05. As of February 10, 2009, there were approximately 620 shareholders of record of our common stock.

        We have never declared or paid any cash dividends on our capital stock. We currently intend to retain any future earnings for funding growth and, therefore, do not anticipate paying any cash dividends in the foreseeable future.

        For information concerning prior stockholder approval of and other matters relating to our equity incentive plans, see "Equity Compensation Plan Information" under Item 12 in this annual report on Form 10-K.

42


Table of Contents


PERFORMANCE MEASUREMENT COMPARISON

        The material in this section is not "soliciting material," is not deemed "filed" with the Securities and Exchange Commission, and is not to be incorporated by reference into any filing of Amylin under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.

        The following graph compares total stockholder returns of Amylin for the past five years to two indices: the NASDAQ CRSP Total Return Index for the NASDAQ Stock Market (U.S. companies), or the NASDAQ-US, and the NASDAQ Pharmaceutical Index, or the NASDAQ-Pharmaceutical. The total return for our common stock and for each index assumes the reinvestment of dividends, although dividends have never been declared on our common stock, and is based on the returns of the component companies weighted according to their capitalizations as of the end of each monthly period. The NASDAQ-US tracks the aggregate price performance of equity securities of U.S. companies traded on the NASDAQ National Market System, or the NMS. The NASDAQ-Pharmaceutical tracks the aggregate price performance of equity securities of pharmaceutical companies traded on the NMS.


COMPARISON OF 5 YEAR CUMULATIVE TOTAL RETURN*
Among Amylin Pharmaceuticals, Inc., The NASDAQ Composite Index
And The NASDAQ Pharmaceutical Index

GRAPHIC

43


Table of Contents

Item 6.    Selected Financial Data

        Please read the following selected financial data in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the Consolidated Financial Statements and related notes included elsewhere in this annual report on Form 10-K.

 
  Years Ended December 31  
 
  2008   2007   2006   2005   2004  
 
  (in thousands, except for per share amounts)
 

Consolidated Statements of Operations Data:

                               

Net product sales

  $ 765,342   $ 701,450   $ 474,038   $ 86,713   $  

Revenues under collaborative agreements

    74,767     79,547     36,837     53,761     34,268  
                       

Total revenues

    840,109     780,997     510,875     140,474     34,268  

Costs and expenses:

                               

Cost of goods sold

    91,596     65,457     50,073     14,784      

Selling, general and administrative

    395,112 (1)   390,982 (1)   281,950 (1)   171,520     66,958  

Research and development

    293,095 (2)   276,600 (2)   222,053 (2)   132,128     119,558  

Collaborative profit-sharing

    302,600     290,934     194,191     31,359      

Restructuring

    54,926 (3)                
                       

Total costs and expenses

    1,137,329     1,023,973     748,267     349,791     186,516  

Make-whole payment on debt redemption

            (7,875 )        

Net interest and other income (expense)

    (3,242 )   31,840     26,411     2,485     (4,909 )

Loss on impairment of investments

    (14,943 )                
                       

Net loss

    (315,405 )   (211,136 )   (218,856 )   (206,832 )   (157,157 )
                       

Net loss per share—basic and diluted

  $ (2.30 ) $ (1.59 ) $ (1.78 ) $ (1.96 ) $ (1.67 )
                       

Shares used in calculating net loss per share—basic and diluted

    137,006     132,621     122,647     105,532     94,054  

Consolidated Balance Sheets Data:

                               

Cash, cash equivalents and short-term investments

  $ 816,838   $ 1,130,415   $ 767,331   $ 443,423   $ 293,756  

Working capital

  $ 722,290   $ 1,049,024   $ 702,930   $ 415,134   $ 282,421  

Total assets

  $ 1,712,629   $ 1,774,211   $ 1,060,386   $ 566,962   $ 357,800  

Long-term obligations, excluding current portion

  $ 1,047,977   $ 934,109   $ 221,208   $ 399,112   $ 403,233  

Accumulated deficit

  $ (1,749,725 ) $ (1,434,320 ) $ (1,223,184 ) $ (1,004,328 ) $ (797,496 )

Total stockholders' equity (deficit)

  $ 350,874   $ 552,818   $ 635,291   $ 69,264   $ (87,370 )

(1)
Selling, general and administrative expenses for the years ended December 31, 2008, 2007 and 2006 include approximately $34.0 million, $35.4 million, and $29.0 million, respectively, of employee stock-based compensation expense pursuant to the provisions of Statement of Financial Accounting Standards No. 123R "Share-Based Payment" which the Company adopted on January 1, 2006.

(2)
Research and development expenses for the years ended December 31, 2008, 2007 and 2006 include approximately $21.1 million, $23.6 million, and $22.9 million, respectively, of employee stock-based compensation expense pursuant to the provisions of Statement of Financial Accounting Standards No. 123R "Share-Based Payment" which the Company adopted on January 1, 2006.

(3)
Restructuring charge for the year ended December 31, 2008 included $0.8 million of employee stock-based compensation expense pursuant to the provisions of Statement of Financial Accounting Standards No. 123R "Share-Based Payment" which the Company adopted on January 1, 2006

44


Table of Contents

Item 7.    Management's Discussion and Analysis of Financial Condition and Results of Operations

Overview

        We are a biopharmaceutical company committed to improving the lives of people with diabetes, obesity and other diseases through the discovery, development and commercialization of innovative medicines. We have developed and gained approval for two first-in-class medicines to treat diabetes, BYETTA® (exenatide) injection and SYMLIN® (pramlintide acetate) injection, both of which were commercially launched in the United States during the second quarter of 2005. BYETTA was approved in the European Union, or EU, in 2006 and our collaboration partner, Lilly has commercially launched BYETTA in 49 countries as of December 31, 2008. Our near-term business strategy is to create value for patients and our stockholders by capitalizing on market drivers, such as the ADA's recent inclusion of BYETTA as the only new addition to their treatment guidelines. Our focus remains on increasing BYETTA and SYMLIN revenue, submitting a New Drug Application, or NDA, for exenatide once weekly, significantly improving operating results and progressing toward positive operating cash flow by the end of 2010. Our long-term strategy is focused on making prudent investment decisions based on strong clinical data to advance our obesity program. We intend to finalize our obesity funding and development strategy by the end of 2009.

        BYETTA is the first and only approved medicine in a new class of compounds called glucagon-like peptide-1, or GLP-1, receptor agonists. We began selling BYETTA in the United States in June 2005. BYETTA is approved in the United States for the treatment of patients with type 2 diabetes who have not achieved adequate glycemic control and are using metformin, a sulfonylurea and/or a TZD, three common oral therapies for type 2 diabetes. In October 2008, the ADA and the European Association for the Study of Diabetes, or EASD, updated their type 2 diabetes treatment guidelines, placing the GLP-1 receptor agonist class, of which BYETTA is the only approved product, as a secondary treatment option for type 2 diabetes patients. In August 2008, the FDA updated a prior alert for BYETTA referencing pancreatitis. Prescriptions declined in the second half of 2008. During that time period we committed our field resources to educating the medical community on the facts about BYETTA, pancreatitis, and the product's safety profile. We believe the decline in BYETTA prescriptions and demand for the products stabilized at the end of the fourth quarter of 2008. Net product sales of BYETTA were $678.5 million, $636.0 million, and $430.2 million for the years ended December 31, 2008, 2007, and 2006, respectively.

        We have an agreement with Lilly for the global development and commercialization of exenatide. This agreement includes BYETTA and any sustained-release formulations of exenatide such as exenatide once weekly, our once weekly formulation of exenatide for the treatment of type 2 diabetes. Under the terms of the agreement, operating profits from products sold in the United States are shared equally between Lilly and us. The agreement provides for tiered royalties payable to us by Lilly based upon the annual gross margin for all exenatide product sales, including any long-acting release formulations, outside of the United States. Royalty payments for exenatide product sales outside of the United States will commence after a one-time cumulative gross margin threshold amount has been met. We expect royalty payments to commence in 2010. Lilly is responsible for 100% of the costs related to development of twice-daily BYETTA for sale outside of the United States. Development costs related to all other exenatide products for sale outside of the United States will continue to be allocated 80% to Lilly and 20% to us. Lilly will continue to be responsible for commercialization and all of the costs related to commercialization of all exenatide products for sale outside of the United States.

        SYMLIN is the first and only approved medicine in a new class of compounds called amylinomimetics. We began selling SYMLIN in the United States in April 2005. Symlin is approved in the United States for the treatment of patients with either type 1 or type 2 diabetes who are treated with mealtime insulin but who have not achieved adequate glycemic control. In early 2008, we commercially launched the SymlinPen® 120 and SymlinPen® 60 pen injector devices in the United

45


Table of Contents


States. These new pre-filled pen-injector devices feature simple, fixed dosing to improve mealtime glucose control. Net product sales of SYMLIN were $86.8 million, $65.5 million and $43.8 million for the years ended December 31, 2008, 2007 and 2006 respectively.

        We have a field force of approximately 650 people dedicated to marketing BYETTA and SYMLIN in the United States. Our field force includes our specialty and primary care sales forces, a managed care and government affairs organization, a medical science organization and diabetes care specialists. In addition, Lilly co-promotes BYETTA in the United States. In May 2008, we amended our United States co-promotion agreement with Lilly, resulting in a 40% increase in the total number of sales representatives promoting BYETTA beginning July 1, 2008. To achieve this increase, Lilly's existing third party sales force for Cialis® (tidalafil) co-promotes BYETTA in the United States and we increased the number of sales representatives in its existing primary care sales force by approximately 15%. In exchange for Lilly sharing in 50% of the costs related to our additional sales representatives and paying 100% of the costs of the third party sales force discussed above, our primary care sales force co-promotes Cialis in the United States. We are currently evaluating this element of the co-promotion arrangement with Lilly.

        In addition to our marketed products, we are working with Lilly and Alkermes to develop exenatide once weekly. We are also working with Parsons on the construction of a manufacturing facility for exenatide once weekly in Ohio. We substantially completed the construction of this facility in 2008. We are now manufacturing exenatide once weekly at commercial scale in this facility and we began supplying clinical trials with this material in the third quarter of 2008. In October 2008 we entered into a commercial supply agreement with Lilly, pursuant to which we will supply exenatide once weekly for sale in the United States, if approved. In addition we will supply Lilly with commercial quantities of exenatide once weekly for sale by Lilly outside of the United States, if approved. Under the terms of this agreement, Lilly made a $125 million cash payment to us in October 2008 representing an amount to compensate us for our cost of carrying Lilly's share of the capital investment in our exenatide once weekly manufacturing facility in Ohio. In addition to the $125 million cash payment, we will recover Lilly's share of the over $500 million capital investment in the facility through an allocation of depreciation to cost of goods sold in accordance with our collaboration agreement with Lilly. The total amount that will ultimately be recovered from Lilly will be dependent upon the proportion of product supplied for sale in the United States, the cost of which is shared equally by the parties, and the proportion of the product supplied for sale outside the United States, the cost of which is paid for 100% by Lilly. We also entered into a loan agreement with Lilly under which we may borrow up to $165 million beginning on December 1, 2009 and ending on June 30, 2011, with maturity no later than June 30, 2014.

        During the second quarter of 2008, we held our pre-NDA meeting with the FDA to discuss open items for our exenatide once weekly regulatory submission. Based on the pre-NDA meeting and our ongoing dialog with the FDA, we continue to believe that the pacing item for an NDA submission is to collect sufficient data to demonstrate the comparability between material manufactured by Alkermes in its facility and used in previous clinical studies and the commercial scale material produced in our Ohio facility. In December 2008, we announced that the FDA has indicated that data from an ongoing extension of our DURATION-1 study could be used to demonstrate comparability. Acceptance by the FDA of the comparability data is dependent upon the DURATION-1 study extension results that we expect to have in early 2009. Although we believe that our exenatide once weekly NDA submission is on track to be completed in the first half of 2009, if we are required to initiate a new clinical study to demonstrate comparability, the timing of the NDA submission would depend on the parameters of the new study, and our submission could be delayed.

        In 2009, we will continue to focus on building a superior profile for exenatide once weekly by conducting three clinical trials that will compare exenatide once weekly against competing products.

46


Table of Contents


The objective of these studies is to support the launch of exenatide once weekly and demonstrate superiority and the transformational nature of our exenatide once weekly therapy.

        In November 2008, we announced a strategic restructuring and workforce reduction that reduced the size of our San Diego workforce by approximately 25%, or 330 employees. The goal of the restructuring was to better align our cost structure with anticipated revenues and is part of our business plan to achieve positive operating cash flow by the end of 2010. We believe we have the appropriate resources to market BYETTA and SYMLIN, bring exenatide once weekly to market as soon as possible, and continue to advance our obesity programs.

        Our long-term growth strategy is focused on making prudent investment decisions based on strong clinical data to advance our obesity program and includes our INTO strategy. In November 2007, we announced that overweight or obese subjects in a 24-week proof-of-concept study treated with a combination of pramlintide, an analog of human amylin and the same active ingredient in SYMLIN, and metreleptin, an analog of human leptin, lost an average of 25 pounds from baseline, resulting in reduced body weight on average of 12.7%. In 2009 we plan to continue the development of a potential obesity medicine that is a combination of pramlintide and metreleptin and the development of a second generation amylinomimetic, now known as davalintide (formerly known as AC2307), which we have now moved into Phase 2 clinical trials. By the end of 2009, we intend to finalize our obesity funding and development strategy.

        Although our efforts will remain primarily focused on our near-term opportunities including BYETTA, SYMLIN and exenatide once weekly and select investments in our obesity programs, we also maintain an active discovery research program focused on novel peptide and protein therapeutics and are actively seeking to in-license additional drug candidates. We have also made a number of strategic investments and collaborations for the potential development of additional drug candidates.

        Since our inception in September 1987, we have devoted substantially all of our resources to our research and development programs and, more recently, to the commercialization of our products. All of our revenues prior to May 2005 were derived from fees and expense reimbursements under our BYETTA collaboration agreement with Lilly, previous SYMLIN collaborative agreements, and previous co-promotion agreements. During the second quarter of 2005, we began to derive revenues from product sales of BYETTA and SYMLIN. At December 31, 2008, our accumulated deficit was approximately $1.7 billion.

        At December 31, 2008, we had $816.8 million in cash, cash equivalents and short-term investments. Additionally we have future availability of $165 million beginning December 1, 2009 pursuant to the loan agreement with Lilly. Although we may not generate positive operating cash flows for the next few of years, we intend to improve our operating results and reduce our use of cash for operating activities from current levels to achieve our goal to be operating cash flow positive by the end of 2010. Additionally, we expect that our use of cash for capital expenditures will decrease significantly from 2008 levels following the substantial completion of our manufacturing facility in Ohio in 2008.            Refer to the discussions under the headings "Liquidity and Capital Resources" below and "Cautionary Factors That May Affect Future Results" in Part I, Item 1A for further discussion regarding our anticipated future capital requirements.

Recent Developments

Diabetes

BYETTA

    Communicated the addition of GLP-1 receptor agonist class, of which BYETTA is the only approved product, to the ADA and EASD treatment guidelines as a secondary treatment option for type 2 diabetes patients.

47


Table of Contents

    Initiated co-promotion of BYETTA with third party Lilly primary care sales force, increasing the sales force promoting BYETTA by 40% effective July 1, 2008.

Exenatide Once Weekly

    Announced that the ongoing extension of the DURATION-1 study is appropriate to use as the basis for demonstrating comparability between intermediate-scale clinical trial material made in Alkermes' manufacturing facility, and commercial-scale drug product made at Amylin's manufacturing facility based on feedback from the U.S. Food and Drug Administration (FDA) and reaffirmed plans for exenatide once weekly NDA submission to the FDA by the end of the first half of 2009.

    Completed enrollment of DURATION-2 and DURATION-3, the second and third studies in a planned program of superiority clinical studies of exenatide once weekly. Results for DURATION-2, comparing exenatide once-weekly against a TZD and a dipeptidyl peptidase-4 (DPP-4) inhibitor on a background of metformin therapy, are expected in the second quarter of 2009. Results for DURATION-3, comparing exenatide once weekly to insulin glargine in patients using oral diabetes medications are expected in the third quarter of 2009.

    Initiated DURATION-4, the fourth study in a planned program of superiority clinical studies of exenatide once weekly. Results for DURATION-4, comparing exenatide once weekly as a monotherapy treatment to either metformin, a TZD or a DPP-4 inhibitor are expected in 2010.

    Executed an exenatide once weekly supply agreement with Lilly, under which Lilly made an initial payment of $125 million to Amylin in the fourth quarter of 2008. In addition, Lilly extended a $165 million line of credit to Amylin. These agreements underscore Amylin's and Lilly's commitment to the successful commercialization of exenatide once weekly, strengthen Amylin's balance sheet and provide additional financial flexibility.

    Announced results from a 52-week open-label clinical study that showed the durable efficacy of exenatide once weekly. Patients taking exenatide once weekly experienced an average A1C decline of 2.0 percent with 9.5 pound weight loss, and over the course of one year, sustained a similar improvement in glucose control compared to those receiving treatment for 30 weeks.

SYMLIN

    Published data showing that the use of mealtime SYMLIN with basal insulin therapy for 24 weeks resulted in more patients with type 2 diabetes achieving improved glucose control, without weight gain or hypoglycemia compared to the use of rapid-acting insulin with basal insulin.

    Commercially launched the SymlinPen 120 and the SymlinPen 60 pen-injector devices for administering SYMLIN in the United States in January 2008. These new pre-filled pen-injector devices feature simple, fixed dosing to improve mealtime glucose control.

Obesity programs

    Presented novel data on Amylin's promising obesity pipeline at The Obesity Society's Scientific Conference that supported the therapeutic potential of the integrated neurohormonal approach to obesity pharmacotherapy.

    Completed enrollment of a phase 2B study to evaluate different dosing combinations of pramlintide and metreleptin. The objective of this dose-ranging study is to support dose selection for phase 3, and to guide the development of a delivery system for this combination regimen. Results from this study are expected in the second half of 2009.

48


Table of Contents

    Completed enrollment of a phase 2 clinical study of davalintide, our second generation amylinomimetic. Results from this study are expected in the second half of 2009

Financial and Operational

    Implemented a strategic restructuring that reduced our San Diego workforce by approximately 25% and announced our business plan to achieve positive operating cash flow by the end of 2010.

Critical Accounting Policies and Estimates

        Our discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates, including those related to revenue recognition, stock-based compensation, inventory costs, research and development expenses and income taxes. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

        We believe the following critical accounting policies affect the significant judgments and estimates used in the preparation of our consolidated financial statements (see Note 1 to our consolidated financial statements on page F-6).

    Revenue Recognition

        We recognize revenue from the sale of our products, license fees and milestones earned and for reimbursement of development costs based on contractual arrangements.

Net Product Sales

        We sell our products primarily to wholesale distributors, who in turn, sell to retail pharmacies, pharmacy benefit managers and government entities. Decisions made by these wholesalers and their customers regarding the level of inventories they hold, and thus the amount of product they purchase, can materially affect the level of our product sales in any particular period.

        We recognize revenue from the sale of our products when delivery has occurred, title has transferred to the customer, the selling price is fixed or determinable, collectability is reasonably assured and the Company has no further obligations. The Company records allowances for product returns, rebates and wholesaler chargebacks, wholesaler discounts and prescription vouchers. We are required to make significant judgments and estimates in determining some of these allowances. If actual results differ from our estimates, we will be required to make adjustments to these allowances in the future.

    Product Returns

        We do not offer our wholesale customers a general right of return. However, we will accept returns of products that are damaged or defective when received by the wholesale customer or for any unopened product during the period beginning six months prior to and up to 12 months subsequent to its expiration date. We estimate product returns based on our historical returns experience. Additionally, we consider several other factors in our estimation process including our internal sales

49


Table of Contents

forecasts, the expiration dates of product shipped and third party data to assist us in monitoring estimated channel inventory levels and prescription trends. Actual returns could exceed our historical experience and our estimates of expected future returns due to factors such as wholesaler and retailer stocking patterns and inventory levels and/or competitive changes. To date actual returns have not differed materially from our estimates.

    Rebates and Wholesaler Chargebacks

        Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program and contracted discounts with commercial payors. Rebates are amounts owed after the final dispensing of the product by a pharmacy to a benefit plan participant and are based upon contractual agreements or legal requirements with private sector and public sector (e.g. Medicaid) benefit providers. The allowance for rebates is based on contractual discount rates, expected utilization under each contract and our estimate of the amount of inventory in the distribution channel that will become subject to such rebates. Our estimates for expected utilization for rebates are based on historical rebate claims and to a lesser extent third party market research data. Rebates are generally invoiced and paid quarterly in arrears so that our accrual consists of an estimate of the amount expected to be incurred for the current quarter's activity, plus an accrual for prior quarters' unpaid rebates and an accrual for inventory in the distribution channel.

        Wholesaler chargebacks are discounts that occur when contracted customers purchase directly from an intermediary wholesale purchaser. Contracted customers, which currently consist primarily of Federal government entities purchasing off the Federal Supply Schedule, generally purchase the product at its contracted price, plus a mark-up from the wholesaler. The wholesaler, in-turn, charges back to the Company the difference between the price initially paid by the wholesaler and the contracted price paid to the wholesaler by the customer. The allowance for wholesaler chargebacks is based on expected utilization of these programs and reported wholesaler inventory levels. Actual rebates and wholesaler chargebacks could exceed historical experience and our estimates of future participation in these programs. To date, actual rebate claims and wholesaler chargebacks have not differed materially from our estimates.

    Wholesaler Discounts

        Wholesaler discounts consist of prompt payment discounts and distribution service fees. We offer all of our wholesale customers a 2% prompt-pay discount within the first 30 days after the date of the invoice. Distribution service fees arise from contractual agreements with certain of our wholesale customers for distribution services they provide to us and are generally a fixed percentage of their purchases of our products in a given period. Prompt payment discounts and distribution service fees are recorded as a reduction to gross sales in the period the sales occur. The allowance for wholesaler discounts is based upon actual data of product sales to wholesale customers and not on estimates.

    Prescription Vouchers

        Prescription vouchers result in amounts owed to pharmacies that have redeemed vouchers for a free prescription. We provide prescription vouchers to physicians, who in turn distribute them to patients. Patients may redeem a voucher at a pharmacy for a free prescription. We reimburse the pharmacy for the price it paid the wholesaler for the medicine and record this reimbursement as a reduction to gross sales. The allowance for prescription vouchers is based on the number of unredeemed vouchers in circulation, and the estimated utilization rate. The estimated utilization rate is based on our historical utilization rates experience with prescription vouchers. The allowance for prescription vouchers could exceed historical experience and our estimates of future utilization rates. To date, actual prescription voucher utilization has not differed materially from our estimates.

50


Table of Contents

Revenues under collaborative agreements

        Amounts received for upfront product and technology license fees under multiple-element arrangements are deferred and recognized over the period of such services or performance if such arrangements require on-going services or performance. Non-refundable amounts received for substantive milestones are recognized upon achievement of the milestone and the expiration of stock conversion rights, if any, associated with such payments. Amounts received for equalization of development expenses are recognized in the period in which the related expenses are incurred. Any amounts received prior to satisfying our revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets.

Valuation of Stock-Based Compensation

        We account for stock-based compensation to employees in accordance with SFAS No. 123R, "Share-Based Payment." SFAS No. 123R requires us to expense the estimated fair value of non-cash, stock-based payments to employees.

        We estimate the fair value of stock-based payments to employees using the Black-Scholes model. This estimate is affected by our stock price as well as assumptions regarding a number of inputs that require us to make significant estimates and judgments. These inputs include the expected volatility of our stock price, the expected term of employee stock options, the risk-free interest rate and expected dividends.

        We estimate volatility based upon the historical volatility of our common stock for a period corresponding to the expected term of our employee stock options and the implied volatility of market-traded options on our common stock with various maturities between six months and two years, consistent with the guidance in SFAS No. 123R and the SEC's Staff Accounting Bulletin, or SAB, No. 107. Prior to the adoption of SFAS No. 123R, we estimated volatility based on the historical volatility of our common stock for a period corresponding to the expected term of our employee stock options. The determination to use implied volatility in addition to historical volatility was based upon the availability of data related to actively traded options on our common stock and our assessment that the addition of implied volatility is more representative of future stock price trends than historical volatility alone.

        The expected life of our employee stock options represents the weighted-average period of time that options granted are expected to be outstanding in consideration of historical exercise patterns and the assumption that all outstanding options will be exercised at the mid-point of the then current date and their maximum contractual term.

        The risk-free interest rates are based on the yield curve of United States Treasury strip securities in effect at the time of grant for periods corresponding with the expected life of our employee stock options. We have never paid dividends and do not anticipate doing so for the foreseeable future. Accordingly, we have assumed no dividend yield for purposes of estimating the fair value of our stock-based payments to employees.

        If factors underlying the above assumptions change in future periods, the associated estimated non-cash, stock-based compensation expense that we record may differ significantly from what we have recorded in the current period.

Inventories and Related Reserves

        Inventories consist of raw materials, work-in-process and finished goods for SYMLIN and BYETTA. We maintain inventory reserves primarily for production failures and potential product expiration. The manufacturing processes for our products are complex. Deviations in the manufacturing process may result in production failures and additional inventory reserves. Obsolete inventory due to

51


Table of Contents


expiration may also result in additional inventory reserves. In estimating inventory obsolescence reserves, we analyze the shelf life, expiration dates and internal sales forecasts, each on a product-by-product basis.

Research and Development Expenses

        Research and development costs are expensed as incurred and include: salaries, benefits, bonus, stock-based compensation, license fees, milestones under license agreements, costs paid to third-party contractors to perform research, conduct clinical trials, and develop drug materials and delivery devices; and associated overhead expenses and facilities costs. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. Invoicing from third-party contractors for services performed can lag several months. We accrue the costs of services rendered in connection with third-party contractor activities based on our estimate of management fees, site management and monitoring costs and data management costs. Differences between actual clinical trial costs from estimated clinical trial costs have historically not been material and are adjusted for in the period in which they become known.

Income Taxes

        We have net deferred tax assets relating primarily to net operating loss carry forwards and research and development tax credits. Subject to certain limitations, these deferred tax assets may be used to offset taxable income in future periods. Since we have been unprofitable since inception and the likelihood of future profitability is not assured, we have reserved for most of these deferred tax assets in our consolidated balance sheets at December 31, 2008 and 2007, respectively. If we determine that we are able to realize a portion or all of these deferred tax assets in the future, we will record an adjustment to increase their recorded value and a corresponding adjustment to increase income in that same period.

        We adopted the provisions of FASB Interpretation Number 48, or FIN 48 and FASB Staff Position, or FSP, FIN 48-1 effective January 1, 2007. FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise's financial statements in accordance with SFAS No. 109, "Accounting for Income Taxes," and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. FIN 48 also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. We had no cumulative effect adjustment related to the adoption due to a full valuation allowance against deferred tax assets. We provide estimates for unrecognized tax benefits. These unrecognized tax benefits relate primarily to issues common among corporations in our industry. We apply a variety of methodologies in making these estimates which include advice from industry and subject experts, evaluation of public actions taken by the Internal Revenue Service and other taxing authorities, as well as our own industry experience. If our estimates are not representative of actual outcomes, our results could be materially impacted.

Recently Issued Accounting Pronouncements

        In May 2008, the FASB issued FSP No. APB 14-1 "Accounting for Convertible Debt Instruments that may be Settled in Cash Upon Conversion (Including Partial Cash Settlement)." FSP No. APB 14-1 establishes that the liability and equity components of convertible debt instruments within the scope of FSP APB No. 14-1 shall be separately accounted for in a manner that will reflect the entity's nonconvertible debt borrowing rate when interest cost is recognized in subsequent periods. The carrying amount of the liability component of the convertible debt instrument will be determined by measuring the fair value of a similar liability that does not have an associated equity component. The carrying value of the equity component will be determined by deducting the fair value of the liability component from the initial proceeds ascribed to the convertible debt instrument as a whole. Related transaction

52


Table of Contents


costs shall be allocated to the liability and equity components in proportion to the allocation of proceeds and accounted for as debt issuance costs and equity issuance costs, respectively. The excess of the principal amount of the liability component over its carrying amount shall be amortized to interest cost using the interest method. FSP No. APB 14-1 is effective for us on January 1, 2009 and shall be applied retrospectively to all periods presented with the cumulative effect of the change in accounting principle on periods prior to those presented recognized as of the beginning of the first period presented. Early adoption is not permitted. We expect that the adoption of FSP No. APB 14-1 will have a material impact on interest expense reported in our consolidated financial statements.

        In March 2008, the FASB issued SFAS No. 161, "Disclosures about Derivative Instruments and Hedging Activities, an amendment of FASB Statement No. 133," which requires additional disclosures about the objectives of using derivative instruments, the method by which the derivative instruments and related hedged items are accounted for under FASB Statement No.133 and its related interpretations, and the effect of derivative instruments and related hedged items on financial position, financial performance and cash flows. SFAS No. 161 also requires disclosure of the fair values of derivative instruments and their gains and losses in a tabular format. SFAS No. 161 is effective for us on January 1, 2009 . We do not expect that the adoption of SFAS No. 161 will have a material impact on our financial statement disclosures.

        In December 2007, the FASB issued SFAS No. 141 (revised 2007), or SFAS No. 141R, "Business Combinations" and SFAS 160, "Noncontrolling Interests in Consolidated Financial Statements, an amendment of Accounting Research Bulletin No. 51." SFAS 141R will change how business acquisitions are accounted for and will impact financial statements both on the acquisition date and in subsequent periods. SFAS No. 160 will change the accounting and reporting for minority interests, which will be recharacterized as noncontrolling interests and classified as a component of equity. SFAS No. 141R and SFAS No. 160 are effective for us on January 1, 2009. Early adoption is not permitted. We do not expect that the adoption of SFAS No. 141R and SFAS No. 160 will have will have a material impact on our consolidated financial statements.

        In December 2007, the FASB ratified the consensuses reached in Emerging Issues Task Force, or EITF, Issue No. 07-1, "Collaborative Arrangements". EITF Issue No. 07-1 defines collaborative arrangements and establishes reporting requirements for transactions between participants in a collaborative arrangement and between participants in the arrangements and third parties. Under EITF Issue No. 07-1, payments between participants pursuant to a collaborative arrangement that are within the scope of other authoritative accounting literature on income statement classification should be accounted for using the relevant provisions of that literature. If the payments are not within the scope of other authoritative accounting literature, the income statement classification for the payments should be based on an analogy to authoritative accounting literature or if there is no appropriate analogy, a reasonable, rational, and consistently applied accounting policy election. EITF Issue No. 07-1 also provides disclosure requirements and is effective for us on January 1, 2009. The effect of applying EITF Issue No. 07-1 will be reported as a change in accounting principle through retrospective applications to all prior periods presented for all collaborative arrangements existing as of the effective date, unless it is impracticable. We do not expect that the adoption of EITF Issue No. 07-1 will have a material impact on our consolidated financial statements.

Results of Operations

Net Product Sales

        Net product sales for the years ended December 31, 2008, 2007 and 2006 were $765.3 million, $701.5 million and $474.0 million, respectively, and consisted of sales of BYETTA and SYMLIN, less allowances for product returns, rebates and wholesaler chargebacks, wholesaler discounts, and prescription vouchers.

53


Table of Contents

        The following table provides information regarding net product sales (in millions):

 
  Year ended December 31,  
 
  2008   2007   2006  

BYETTA

  $ 678.5   $ 636.0   $ 430.2  

SYMLIN

    86.8     65.5     43.8  
               

  $ 765.3   $ 701.5   $ 474.0  
               

        The increases in net product sales for BYETTA and SYMLIN for the year ended December 31, 2008 as compared to the same period in 2007 and the increases in net product sales for BYETTA and SYMLIN for the year ended December 31, 2007 as compared to the same period in 2006 primarily reflect continued growth in patient demand and the impact of price increases. Sales of our products in future periods may be impacted by numerous factors, including potential competition, the potential approval of additional products including exenatide once weekly, regulatory matters, including potential label changes for BYETTA, economic factors and other environmental factors.

Revenues under Collaborative Agreements

        The following table summarizes the components of revenues under collaborative agreements for the years ended December 31, 2008, 2007 and 2006 (in millions):

 
  Year ended December 31,  
 
  2008   2007   2006  

Amortization of up-front payments

  $ 4.3   $ 4.3   $ 4.3  

Recognition of milestone payments

        15.0      

Cost-sharing payments

    70.5     60.2     32.5  
               

  $ 74.8   $ 79.5   $ 36.8  
               

        Substantially all of the revenue recorded in these periods consists of amounts earned pursuant to our BYETTA collaboration agreement with Lilly and consists primarily of the continued amortization of up-front payments, milestone payments and cost-sharing payments to equalize development expenses for BYETTA and exenatide once weekly.

        The $4.7 million decrease in revenues under collaborative agreements in 2008, as compared to 2007, primarily reflects increased cost-sharing payments partially offset by a reduction in milestone payments. The increase in cost-sharing payments in 2008, as compared to 2007, reflects Lilly's reimbursement to us for increased development expenses for exenatide one weekly. There were no milestone payments in 2008, compared to $15 million in milestone payments in 2007 earned primarily upon Lilly's launch of BYETTA in the European Union in 2007. The $42.7 million increase in revenues under collaborative agreements in 2007, as compared to 2006, primarily reflects increases in milestone payments due to the recognition of $15 million in milestone payments discussed above and increased cost-sharing payments. The increase in cost-sharing payments in 2007, as compared to 2006, primarily reflects Lilly's reimbursement for increased development expenses incurred by us for exenatide once weekly.

        In future periods, we expect that revenues under collaborative agreements will consist of ongoing cost-sharing payments from Lilly for sharing of development costs, possible future milestone payments, continued amortization of the $30 million portion of the up-front payment received from Lilly upon signing of our collaboration agreement in 2002 and, following the commercial launch of exenatide once-weekly, the amortization of a portion of the $125 million cash payment received in connection with the exenatide once weekly supply agreement discussed above. The amount of cost-sharing revenue recorded will be dependent on the timing, extent and relative proportion of total development costs for

54


Table of Contents


the exenatide once weekly and BYETTA development programs incurred by us and by Lilly. The receipt and recognition as revenue of future milestone payments is subject to the achievement of performance requirements underlying such milestone payments.

Cost of Goods Sold

        Cost of goods sold was $91.6 million, representing a gross margin of 88%, $65.5 million, representing a gross margin of 91%, and $50.1 million, representing a gross margin of 89%, for the years ended December 31, 2008, 2007 and 2006, respectively. Cost of goods sold is comprised primarily of manufacturing costs associated with BYETTA and SYMLIN sales during the period. The decrease in gross margin in 2008, as compared to 2007, primarily reflects increased production costs for BYETTA due to lower production volumes, increases in inventory reserves and product mix, including the introduction of the SymlinPen, partially offset by higher net sales prices per unit for BYETTA and SYMLIN. The improvement in gross margin in 2007, as compared to 2006, primarily reflects a higher average net sales price per unit for BYETTA and lower unit costs for BYETTA resulting from higher production volumes. Annual fluctuations in gross margins may be influenced by production volumes, product mix, pricing and the level of sales allowances.

Selling, General and Administrative Expenses

        Selling, general and administrative expenses were $395.1 million, $391.0 million and $282.0 million in the years ended December 31, 2008, 2007 and 2006, respectively.

        The $4.1 million increase in 2008 as compared to 2007 reflects slight increases in promotional spending for BYETTA and SYMLIN and business infrastructure. We expect selling, general and administrative expenses to decrease in 2009 due our reduced cost structure following our strategic restructuring and workforce reduction implemented during the quarter ended December 31, 2008, discussed below and in Note 5 to the accompanying financial statements.

        The $109.0 million increase in 2007 as compared to 2006 reflects the full annual effect of the expansion of our sales force during the fourth quarter of 2006, increased promotional expenses for BYETTA and SYMLIN, increased business infrastructure to support our growth and an increase in stock-based compensation including costs associated with the adoption of our employee stock ownership plan, or ESOP, and increased expense from stock options due to growth in our number of employees.

        We, along with Lilly, are jointly responsible for the co-promotion of BYETTA within the United States, and share equally in sales force costs and external marketing expenses. Accordingly, our selling, general and administrative expenses include our 50% share of these costs in the United States.

Research and Development Expenses

        Currently, our research and development efforts are focused on programs for the treatment of diabetes and obesity in various stages of development. From inception through 1998, we devoted substantially all of our research and development efforts to SYMLIN. Beginning in 1999, our research and development costs started to include costs for our other drug candidates, primarily BYETTA and exenatide once weekly. In 2004 we initiated our program for the treatment of obesity with pramlintide and in 2006 we commenced our INTO clinical research program for obesity.

        The drug development process in the United States includes a series of steps defined by the FDA. The process begins with discovery and preclinical evaluation leading up to the submission of an IND to the FDA, which allows for the initiation of the clinical evaluation of a potential drug candidate in humans. Clinical evaluation is typically comprised of three phases of study: Phase 1, Phase 2 and Phase 3. Generally, the majority of a drug candidate's total development costs are incurred during

55


Table of Contents


Phase 3, which consists of trials that are typically both the longest and largest conducted during the drug development process. Successful completion of Phase 3 clinical testing is followed by the submission of an NDA to the FDA for marketing approval. It is not uncommon for the FDA to request additional data following its review of an NDA, which can significantly increase the drug development timeline and expenses. Following initial regulatory approval for a drug candidate, companies generally initiate additional clinical trials aimed at expanding product labeling and market potential.

        The timing and costs to complete the successful development of any of our drug candidates are highly uncertain, and therefore difficult to estimate.

        Our research and development costs are comprised of salaries and bonuses, benefits, non-cash stock-based compensation; license fees, milestones under license agreements, costs paid to third-party contractors to perform research, conduct clinical trials, and develop drug materials and delivery devices; and associated overhead expenses and facilities costs. We charge direct internal and external program costs to the respective development programs. We also incur indirect costs that are not allocated to specific programs because such costs benefit multiple development programs and allow us to increase our pharmaceutical development capabilities. These consist primarily of facilities costs and other internal shared resources related to the development and maintenance of systems and processes applicable to all of our programs.

        The following table sets forth information regarding our research and development expenses for our major projects for the years ended December 31, 2008, 2007 and 2006 (in millions):

 
  Year ended December 31,  
 
  2008   2007   2006  

Diabetes(1)

  $ 152.7   $ 150.2   $ 104.5  

Obesity

    55.3     51.5     43.9  

Research and early-stage programs

    31.5     29.3     40.8  

Indirect costs

    53.6     45.6     32.9  
               

  $ 293.1   $ 276.6   $ 222.1  
               

      (1)
      Research and development expenses consist primarily of costs associated with Byetta and exenatide once weekly which are shared by Lilly pursuant to our collaboration agreement. Cost-sharing payments received by Lilly are included in revenues under collaborative agreements. Increased expenditures for our diabetes development programs are generally partially offset by an increase in cost-sharing payments from Lilly. Cost-sharing payments were $70.5 million, $60.2 million and $32.5 million for the years ended December 31, 2008, 2007 and 2006, respectively

        Research and development expenses increased to $293.1 million for the year ended December 31, 2008 from $276.6 million for the year ended December 31, 2007. The $16.5 million increase in 2008 as compared to 2007 primarily reflects continued investments in exenatide once weekly, including manufacturing scale up at our Ohio manufacturing facility and costs associated with the ongoing DURATION clinical trials discussed above, and continued investment in our obesity development programs, including costs associated with the ongoing Phase 2B study evaluating pramlintide and metreleptin discussed above. We expect that research and development expenses will decrease in 2009 due to our lower cost structure following the restructuring we implemented in the quarter ended December 31, 2008, discussed below and in Note 5 to the accompanying financial statements.

        Research and development expenses increased to $276.6 million for the year ended December 31, 2007 from $222.1 million for the year ended December 31, 2006. The $54.5 million increase in 2007 as

56


Table of Contents


compared to 2006 primarily reflects increased expenses associated with our diabetes programs. The increase in expenses for our diabetes programs primarily reflects increased expenses for exenatide once weekly associated with manufacturing scale-up at third-party manufacturers and our manufacturing facility in Ohio and expenses associated with a 30-week comparator study of exenatide once-weekly injection and BYETTA taken twice daily in patients with type 2 diabetes we completed in the fourth quarter of 2007.

Collaborative Profit-Sharing

        Collaborative profit-sharing was $302.6 million, $290.9 million and $194.2 million for the years ended December 31, 2008, 2007 and 2006, respectively, and consists of Lilly's 50% share of the gross margin for BYETTA sales in the United States.

Restructuring

        In November 2008 we announced a strategic restructuring and workforce reduction that reduced the size of our San Diego workforce by approximately 25%, or 330 employees. The goal of the restructuring was to better align our cost structure with anticipated revenues and is part of our business plan to be operating cash flow positive by the end of 2010. We believe we have appropriate resources to grow product sales from BYETTA and SYMLIN and bring exenatide once weekly to market as soon as possible.

        In addition, we also consolidated our San Diego facilities and have sub-leased or intend to sublease exited facilities. In connection with the restructuring, we recorded a charge of $54.9 million for the year ended December 31, 2008. This charge consists primarily of expenses related to facility leases for exited facilities, including impairments of related tenant improvements and employee separation benefits.

        The following table sets forth the components of the restructuring charge (in millions):

 
  Year ended December 31, 2008  

Facility related charges

  $ 31.3  

Employee separation costs

    13.9  

Asset impairments

    8.8  

Other restructuring charges

    0.9  
       

  $ 54.9  
       

        We have substantially completed all of the above activities included in the restructuring plan and all costs associated with the restructuring were incurred during the year ended December 31, 2008.

Make-whole Payment on Debt Redemption

        In July 2006, we called for the redemption on August 24, 2006 of all our outstanding convertible senior notes due June 2008, or the 2003 Notes, under a provisional redemption based upon the market price of our common stock exceeding certain thresholds. All holders elected to convert their 2003 Notes into shares of our common stock. In connection with the conversion, we issued approximately 5.6 million shares, including 180,005 shares as a make-whole payment, representing $112.94 per $1,000 principal amount of the 2003 Notes converted less interest actually paid. In connection with this make-whole payment, we recorded a non-cash, non-operating charge of $7.9 million during the third quarter of 2006.

57


Table of Contents

Interest and Other Income and Expense

        Interest and other income consist primarily of interest income from investment of cash and investments. Interest and other income was $26.6 million in 2008, $47.0 million in 2007 and $34.9 million in 2006. The decrease in 2008 compared to 2007 primarily reflects lower average investment balances and lower interest rates in 2008 as compared to 2007. The increase in 2007 compared to 2006 primarily reflects higher average investment balances due to net proceeds of $558.7 million from the sale of the 2007 Notes.

        Interest and other expense consist primarily of interest expense resulting from our long-term debt obligations and includes interest payments and the amortization of debt issuance costs. Interest and other expense was $29.8 million in 2008, $15.1 million in 2007 and $8.5 million in 2006. The increase in 2008 compared to 2007 primarily reflects additional interest expense for our 2007 notes and $125 million long-term note payable entered into in December 2007. The increase in 2007 compared to 2006 primarily reflects an increase in additional interest expense for our 2007 Notes.

Loss on Impairment of Investments

        We recognized a loss on impairment of investments of $14.9 million for the year ended December 31, 2008. This primarily represents a recognized $9.0 million other-than-temporary impairment loss on an equity investment in a privately held entity based upon our assessment of the entity's financial and technical performance and the entity's ability to raise additional capital in significantly deteriorated financial markets to fund ongoing operations. We also recognized a $5.9 million other-than-temporary impairment loss on a corporate debt security in our investment portfolio based upon our assessment of the impact of bankruptcy proceedings of the issuer on the recoverability of our investment. At December 31, 2008, gross unrealized losses on our short-term investments were $9.0 million, all of which we determined to be temporary.

Net Loss

        Our net loss for the year ended December 31, 2008 was $315.4 million compared to $211.1 million in 2007 and $218.9 million in 2006. The increase in our net loss in 2008 compared to 2007 primarily reflects the increased expenses, including the restructuring charge, partially offset by the increased net product sales discussed above. The decrease in our net loss in 2007 compared to 2006 primarily reflects increased net product sales and revenues under collaborative agreements, partially offset by increased selling, general, and administrative expenses, increased research and development expenses and increased collaborative profit-sharing discussed above.

        We may incur operating losses for the next few years. In November 2008 we announced our restructuring and our business plan to become operating cash flow positive by the end of 2010. However, our ability to reach profitability in the future will be heavily dependent upon the amount of product sales that we achieve for BYETTA, SYMLIN and exenatide once weekly, if approved and our ability to control our operating expenses, including ongoing expenses associated with the continued commercialization of BYETTA and SYMLIN, costs associated with the development and commercialization of exenatide once weekly, if approved, and expenses associated with our research and development programs, including our obesity and our early-stage development programs and related support infrastructure. Our operating results may fluctuate from quarter to quarter as a result of differences in the timing of expenses incurred and revenues recognized.

Liquidity and Capital Resources

        Since our inception, we have financed our operations primarily through public sales and private placements of our common and preferred stock, debt financings, payments received pursuant to our BYETTA collaboration with Lilly, reimbursement of SYMLIN development expenses through earlier

58


Table of Contents


collaboration agreements, and since the second quarter of 2005, through product sales of BYETTA and SYMLIN.

        At December 31, 2008, we had $816.8 million in cash, cash equivalents and short-term investments, compared to $1.1 billion at December 31, 2007 and we have future availability of $165 million beginning December 1, 2009 pursuant to the loan agreement with Lilly. In November 2008, following our restructuring, we announced our business plan to be operating cash flow positive by the end of 2010. Additionally, we expect that our use of cash for capital expenditures will decrease significantly following the substantial completion of our manufacturing facility in Ohio in 2008. Therefore our current business plan does not contemplate a need to raise additional funds from outside sources however, we will continue to evaluate the performance of our business and strategic opportunities which may require us to raise additional funds from outside sources in the future. If we require additional financing in the future, we cannot assure you that it will be available to us on favorable terms, or at all. Although we have previously been successful in obtaining financing through our debt and equity securities offerings, there can be no assurance that we will be able to so in the future, especially given the current adverse economic and credit conditions.

        We used cash of $19.5 million, $125.2 million and $126.0 million for our operating activities in the years ended December 31, 2008, 2007 and 2006, respectively. Our cash used for operating activities reflect a source of cash due to the $125 million cash payment received from Lilly in connection with exenatide once-weekly supply agreement signed in October 2008. In addition, our cash used for operating activities in 2008 included uses of cash due to increases in other current assets and inventories of $13.0 million and $15.6 million, respectively and a decrease in payable to collaborative partner of $5.6 million. The increase in other current assets reflects prepayments for raw material inventory and the increase in inventories reflects inventory purchases in accordance with contractual agreements. The decrease in payable to collaborative partner primarily reflects lower gross profit on BYETTA sales, of which 50% is payable to Lilly, in the quarter ending December 31, 2008 as compared to the same period in 2007. Our cash used for operating activities in 2008 included sources of cash for increases in our current liabilities, including an increase of $8.6 million in accounts payable and accrued liabilities, an increase of $4.9 million in accrued compensation, an increase of $46.7 million in accrued restructuring costs, of which $24.2 million is classified as current, and a decrease in accounts receivable of $11.2 million. The increase in accounts payable and accrued liabilities primarily reflects growth in our expenses generally, and accounts payable timing differences. The increase in accrued compensation primarily reflects an increased accrual for our ESOP, which will be funded with shares of our common stock in the quarter ending March 31, 2009. The increase in accrued restructuring costs reflects accrued expenses associated with our recent restructuring and consists primarily of the fair value of net cash payments related to facility lease losses.

        Our investing activities used cash of $182.2 million, $296.1 million and $425.9 million in the years ended December 31, 2008, 2007 and 2006, respectively. Investing activities in all three years consisted primarily of purchases and sales of short-term investments and purchases of property, plant and equipment. Purchases of property, plant and equipment increased to $295.1 million in 2008, from $268.7 million in 2007 and $97.9 million in 2006. The increases in 2008 and 2007 primarily reflect costs associated with our manufacturing facility for exenatide once weekly and, to a lesser extent, purchases of tenant improvements, computer software, office equipment and scientific equipment to support our growth. We expect that our capital expenditures will decrease significantly in 2009 following the substantial completion of our Ohio manufacturing facility in 2008. Through December 31, 2008, we had expended in excess of $522.5 million associated with the construction of this facility which includes costs associated with the construction of the facility, purchase and installation of equipment and capitalized labor and materials required to validate the facility. We will continue to evaluate potential additional investments in our Ohio manufacturing facility during the product lifecycle for exenatide once weekly.

59


Table of Contents

        Financing activities provided cash of $16.7 million, $776.9 million and $546.5 million in the years ended December 31, 2008, 2007 and 2006, respectively. Financing activities in 2008 include proceeds from the exercise of stock options and proceeds from our employee stock purchase plan. Financing activities for 2007 included proceeds from the exercise of stock options, proceeds from our employee stock purchase plan and $559 million in net proceeds from the issuance of the 2007 Notes. Financing activities for 2006 included proceeds from the exercise of stock options, proceeds from our employee stock purchase plan and $508 million in net proceeds from a public offering of 11.5 million shares of our common stock in April 2006.

        At December 31, 2008, we had $200 million in aggregate principal amount of the 2004 Notes due 2011 and $575 million of the 2007 Notes due 2014 outstanding. The 2004 Notes are currently convertible into a total of up to 5.8 million shares of our common stock at approximately $34.35 per share and are not redeemable at our option. The 2007 Notes are currently convertible into a total of up to 9.4 million shares of our common stock at approximately $61.07 per share and are not redeemable at our option.

        In December 2007, we entered into a $140 million credit agreement. The credit agreement provides for a $125 million term loan and a $15 million revolving credit facility. The revolving credit facility also provides for the issuance of letters of credit and foreign exchange hedging up to the $15 million borrowing limit. The term loan is repayable on a quarterly basis, with no payments due quarters one through four, 6.25% of the outstanding principal due quarters five through eleven, and 56.25% of the outstanding principal due in quarter twelve. At December 31, 2008 we had an outstanding balance of $125 million under the term loan and had issued $5.6 million of standby letters of credit under the revolving credit facility. Both loans have a final maturity date of December 21, 2010. Interest on the term loan is payable quarterly in arrears at a rate equal to 1.75% above the London Interbank Offered Rate, or LIBOR, of either one, two, three or six months LIBOR term at our election. We have entered into an interest rate swap agreement which resulted in a fixed interest rate of 5.717% under the term loan. The interest rate on the credit facility is LIBOR plus 1.0% or the Bank of America prime rate, at our election.

        In October 2008, we entered into a loan agreement with Lilly pursuant to which Lilly will make available to us a $165 million unsecured line of credit that we can draw upon from time to time beginning on December 1, 2009 and ending on June 30, 2011. Any interest due under this credit facility will bear interest at the five-day average three-month LIBOR rate immediately prior to the date of the advance plus 5.25% and shall be due and payable quarterly in arrears on the first business day of each quarter. All outstanding principal, together with all accrued and unpaid interest, shall be due and payable the earlier of 36 months following the date on which the loan commitment is fully advanced or June 30, 2014.

60


Table of Contents

        The following table summarizes our contractual obligations and maturity dates as of December 31, 2008 (in thousands).

 
  Payments Due by Period  
Contractual Obligations
  Total   Less
than 1
year
  2-3
years
  4-5
years
  After 5
years
 

Long-term convertible debt

  $ 775,000   $   $ 200,000   $   $ 575,000  

Interest on long-term convertible debt

    107,375     22,250     42,000     34,500     8,625  

Long-term note payable

    125,000     31,250     93,750          

Interest on long-term note payable, net of swap transactions(1)

    11,166     6,476     4,690          

Inventory purchase obligations(2)

    384,128     107,034     131,159     145,935      

Construction contracts

    38,900     38,900              

Operating leases

    210,862     23,422     46,928     49,485     91,027  
                       

Total(3)

  $ 1,652,431   $ 229,332   $ 518,527   $ 229,920   $ 674,652  
                       

(1)
The interest payments shown were calculated using a rate of 5.717%, the net rate from the term loan and interest rate swap, on the outstanding principal balance of the term loan.

(2)
Includes $42.2 million of outstanding purchase orders, cancelable by us upon 30 days' written notice, subject to reimbursement of costs incurred through the date of cancellation. Also includes $311.8 million of commitments for exenatide once weekly that are contingent upon FDA approval of exenatide once weekly.

(3)
Excludes long-term obligation of $6.3 million related to deferred compensation, the payment of which is subject to elections made by participants that are subject to change.

        In addition, under certain license and collaboration agreements we are required to pay royalties and/or milestone payments upon the successful development and commercialization of related products. We expect to make development milestone payments up to $1.8 million associated with licensing agreements in the next 12 months. Additional milestones of up to approximately $301.7 million could be paid over the next ten to fifteen years if development and commercialization of all our early stage programs continue and are successful. The significant majority of these milestones relate to potential future regulatory approvals and subsequent sales thresholds. Given the inherent risk in pharmaceutical development, it is highly unlikely that we will ultimately make all of these milestone payments; however, we would consider these payments as positive because they would signify that the related products are moving successfully through development and commercialization.

        Our future capital requirements will depend on many factors, including: the amount of product sales we and Lilly achieve for BYETTA and we achieve for SYMLIN and exenatide once weekly, if approved; costs associated with the continued commercialization of BYETTA and SYMLIN; costs associated with the establishment of our exenatide once weekly manufacturing facility; costs of potential licenses or acquisitions; the potential need to repay existing indebtedness; costs associated with an increase in our infrastructure; our ability to receive or need to make milestone payments; our ability, and the extent to which we establish collaborative arrangements for SYMLIN or any of our product candidates; progress in our research and development programs and the magnitude of these programs; costs involved in preparing, filing, prosecuting, maintaining, enforcing or defending our patents; competing technological and market developments; and costs of manufacturing, including costs associated with establishing our own manufacturing capabilities or obtaining and validating additional manufacturers of our products; and scale-up costs for our drug candidates.

61


Table of Contents

Off-Balance Sheet Arrangements

        We do not have any off-balance sheet arrangements that are currently or reasonably likely to be material to our consolidated financial position or results of operations.

Item 7A.    Quantitative and Qualitative Disclosures about Market Risk

        We invest our excess cash primarily in United States Government securities, asset-backed securities, and debt instruments of financial institutions and corporations with investment-grade credit ratings. These instruments have various short-term maturities. We do not utilize derivative financial instruments, derivative commodity instruments or other market risk sensitive instruments, positions or transactions in any material fashion. Accordingly, we believe that, while the instruments held are subject to changes in the financial standing of the issuer of such securities, we are not subject to any material risks arising from changes in interest rates, foreign currency exchange rates, commodity prices, equity prices or other market changes that affect market risk sensitive investments. Our debt is not subject to significant swings in valuation as interest rates on our debt are fixed. The fair value of our 2004 Notes and 2007 Notes at December 31, 2008 was approximately $150 million and $260 million, respectively. We have entered into an interest rate swap in connection with our $125 million term loan. The fair value of the interest rate swap at December 31, 2008 was a liability of $5.0 million. A hypothetical 1% adverse move in interest rates along the entire interest rate yield curve would not materially affect the fair value of our financial instruments that are exposed to changes in interest rates.

Item 8.    Financial Statements and Supplementary Data

        The financial statements and supplemental data required by this item are set forth at the pages indicated in Part IV, Item 15(a)(1) of this annual report.

Item 9.    Changes In and Disagreements with Accountants on Accounting and Financial Disclosure

        None.

Item 9A.    Controls and Procedures

Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures

        Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of our disclosure controls and procedures as such term is defined under Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended, or the Exchange Act. Based on this evaluation, our principal executive officer and our principal financial officer concluded that our disclosure controls and procedures were effective as of December 31, 2008.

        Our management does not expect that our disclosure controls and procedures or our internal controls over financial reporting will prevent all potential error and fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, or misstatements due to error, if any, within the Company have been detected. While we believe that our disclosure controls and procedures and internal control over financial reporting are and have been effective, we intend to continue to examine and refine our disclosure controls and procedures and internal control over financial reporting and to monitor ongoing developments in these areas.

62


Table of Contents

Management's Report on Internal Control Over Financial Reporting

        Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation under the framework in Internal Control—Integrated Framework, our management concluded that our internal control over financial reporting was effective as of December 31, 2008. The effectiveness of our internal control over financial reporting as of December 31, 2008 has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in their report which is included herein.

Changes in Internal Control Over Financial Reporting

        There has been no change in our internal control over financial reporting in our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

63


Table of Contents

Report of Independent Registered Public Accounting Firm on Internal Control Over Financial Reporting

The Board of Directors and Stockholders of Amylin Pharmaceuticals, Inc.

        We have audited Amylin Pharmaceuticals, Inc.'s internal control over financial reporting as of December 31, 2008, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). Amylin Pharmaceuticals, Inc.'s management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management's Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the company's internal control over financial reporting based on our audit.

        We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

        A company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company's internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements.

        Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

        In our opinion, Amylin Pharmaceuticals, Inc. maintained, in all material respects, effective internal control over financial reporting as of December 31, 2008, based on the COSO criteria.

        We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the accompanying consolidated balance sheets of Amylin Pharmaceuticals, Inc. as of December 31, 2008 and 2007, and the related consolidated statements of operations, stockholders' equity, and cash flows for each of the three years in the period ended December 31, 2008 of Amylin Pharmaceuticals, Inc. and our report dated February 23, 2009 expressed an unqualified opinion thereon.

    /s/ Ernst & Young LLP
San Diego, California
February 23, 2009
   

64


Table of Contents


PART III

Item 9B.    Other Information

        None.

Item 10.    Directors, Executive Officers and Corporate Governance

        The information required by this item with respect to executive officers and directors is incorporated by reference from the information under the captions "Election of Directors," "Section 16(a) Beneficial Ownership Reporting Compliance," and "Code of Business Conduct and Ethics" contained in the proxy statement to be filed with the SEC pursuant to Regulation 14A in connection with our 2009 annual meeting of stockholders.

Item 11.    Executive Compensation

        The information required by this item is incorporated by reference to the information under the captions "Compensation of Directors," "Executive Compensation," "Report of the Compensation Committee of the Board of Directors on Executive Compensation," and "Compensation Committee Interlocks and Insider Participation" contained in the proxy statement to be filed with the SEC pursuant to Regulation 14A in connection with our 2009 annual meeting of stockholders.

Item 12.    Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters

        The information required by this item is incorporated by reference to the information under the captions "Security Ownership of Certain Beneficial Owners and Management" and "Equity Compensation Plan Information" contained in the proxy statement to be filed with the SEC pursuant to Regulation 14A in connection with our 2009 annual meeting of stockholders.

Item 13.    Certain Relationships and Related Transactions, and Director Independence

        The information required by this item is incorporated by reference to the information under the captions "Election of Directors" and "Certain Transactions" contained in the proxy statement to be filed with the SEC pursuant to Regulation 14A in connection with our 2009 annual meeting of stockholders.

Item 14.    Principal Accountant Fees and Services

        The information required by this item is incorporated by reference to the information under the caption contained in "Ratification of Selection of Independent Registered Public Accounting Firm" contained in the proxy statement to be filed with the SEC pursuant to Regulation 14A in connection with our 2009 annual meeting of stockholders.

65


Table of Contents


PART IV

Item 15.    Exhibits and Financial Statement Schedules

(a)(1) Index to Consolidated Financial Statements

        The financial statements required by this item are submitted in a separate section beginning on page F-1 of this annual report.

(a)(2) Financial Statement Schedules: The following Schedule is filed as part of this annual report on Form 10-K:

 
  Page Number

II. Valuation Accounts

  F-38

        All other schedules have been omitted because they are not applicable or required, or the information required to be set forth therein is included in the Consolidated Financial Statements or notes thereto.

(a)(3) Index to Exhibits—See Item 15(b) below.

(b)
Exhibits
Exhibit Footnote   Exhibit Number    
  (1)     3.1   Amended and Restated Certificate of Incorporation of the Registrant.
  (5)     3.2   Fourth Amended and Restated Bylaws of the Registrant.
  (11)     3.3   Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant.
  (31)     3.4   Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant.
        4.1   Reference is made to Exhibits 3.1 - 3.4.
  (15)(2)     4.2   Registration Rights Agreement dated September 19, 2002, between the Registrant and Eli Lilly and Company.
  (14)     4.3   Rights Agreement dated June 17, 2002, between the Registrant and American Stock Transfer & Trust Company.
  (14)     4.4   Certificate of Designation of Series A Junior Participating Preferred Stock.
  (20)     4.5   First Amendment to Rights Agreement dated December 13, 2002, between the Registrant and American Stock Transfer & Trust Company.
  (8)     4.6   Indenture, dated as of April 6, 2004, between Registrant and J.P. Morgan Trust Company, National Association (as Trustee).
  (8)     4.7   Form of 2.50% Convertible Senior Note due 2011.
  (30)     4.8   Indenture, dated as of June 8, 2007, between Registrant and The Bank of New York Trust Company, N.A. (as Trustee).
  (30)     4.9   Registration Rights Agreement, dated as of June 8, 2007, among Registrant, Goldman Sachs & Co. and Morgan Stanley & Co. Incorporated.
  (1)     10.1   Form of Indemnity Agreement entered into between the Registrant and its directors and officers.†
  (12)     10.2   Registrant's 1991 Stock Option Plan, as amended.†
  (4)     10.3   Form of Incentive Stock Option Agreement under the 1991 Stock Option Plan.†
  (1)     10.4   Form of Supplemental Stock Option Agreement under the 1991 Stock Option Plan.†
  (1)     10.5   Form of Supplemental Stock Option Agreement not granted under the 1991 Stock Option Plan with related schedule.†

66


Table of Contents

Exhibit Footnote   Exhibit Number    
  (29)     10.6   Registrant's Amended and Restated 2001Employee Stock Purchase Plan.†
  (16)     10.7   Registrant's Non-Employee Directors' Stock Option Plan (the "Directors' Plan").†
  (3)     10.8   Phantom Stock Unit Agreement, dated January 4, 1995, between the Registrant and Farview Management Co., L.P.†
  (6)(2)     10.9   Patent and Technology License Agreement, Consulting Agreement and Nonstatutory Stock Option Agreement dated October 1, 1996, between the Registrant and Dr. John Eng.
  (7)     10.10   Registrant's Directors' Deferred Compensation Plan.†
  (17)     10.11   Registrant's Directors' Plan Stock Option Agreement, as amended. †
  (9)     10.12   Special Form of Incentive Stock Option Agreement the 1991 Stock Option Plan of the Registrant.†
  (10)     10.13   Stock Option Agreement dated March 25, 1998, between the Registrant and Joseph C. Cook, Jr.†
  (13)(2)     10.14   Development and License Agreement dated May 15, 2000, between the Registrant and Alkermes Controlled Therapeutics II, Inc.
        10.15   Registrant's Amended and Restated Officer Change in Control Severance Benefit Plan. †
  (26)     10.16   Registrant's Amended and Restated 2001 Equity Incentive Plan.†
  (15)(2)     10.17   Collaboration Agreement dated September 19, 2002, between the Registrant and Eli Lilly and Company.
  (15)(2)     10.18   U.S. Co-Promotion Agreement dated September 19, 2002, between the Registrant and Eli Lilly and Company.
  (15)     10.19   Milestone Conversion Agreement dated September 19, 2002, between the Registrant and Eli Lilly and Company.
  (18)(2)     10.20   Device Development and Manufacturing Agreement dated July 1, 2003, between Registrant and Eli Lilly and Company.
  (17)     10.21   Form of Registrant's 2001 Equity Incentive Plan Officer Stock Option Agreement, as amended. †
  (17)     10.22   Form of Registrant's 2001 Equity Incentive Plan Stock Option Agreement, as amended. †
  (19)(2)     10.23   Manufacturing Agreement dated May 12, 2003, between Registrant and UCB S.A.
  (21)(2)     10.24   Exenatide Manufacturing Agreement dated October 21, 2003, between Registrant and Mallinckrodt Inc.
  (21)(2)     10.25   Commercial Supply Agreement for Exenatide dated December 23, 2003, between Registrant and Bachem, Inc.
  (22)(2)     10.26   Commercial Supply Agreement dated February 14, 2005 between Registrant and Baxter Pharmaceutical Solutions LLC.
  (22)(2)     10.27   Commercial Supply Agreement dated March 2, 2005 between Registrant and Baxter Pharmaceutical Solutions LLC.
        10.28   Summary Description of Registrant's Named Executive Officer Oral At-Will Employment Agreements. †
  (23)     10.29   Description of Registrant's Executive Cash Bonus Plan. †
  (25)(2)     10.30   Amendment to Development and License Agreement dated October 24, 2005, between Registrant and Alkermes Controlled Therapeutics II.
  (24)(2)     10.31   Commercial Supply Agreement dated June 28, 2005, between Registrant and Bachem, Inc.

67


Table of Contents

Exhibit Footnote   Exhibit Number    
  (27)(2)     10.32   Commercial Supply Agreement dated October 12, 2006 between Registrant and Wockhardt UK (Holdings) Ltd.
  (27)(2)     10.33   Amendment to Collaboration Agreement dated October 31, 2006 between Registrant and Eli Lilly and Company.
  (28)     10.34   Employment Agreement, dated March 7, 2007, by and between Registrant and Daniel M. Bradbury. †
  (32)     10.35   Registrant's 2001 Non-Qualified Deferred Compensation Plan. †
  (32)     10.36   Credit Agreement, dated as of December 21, 2007, among Registrant, The Bank of America, N.A. (as Administrative Agent) and the other lenders set forth therein.
  (33)     10.37   First Amendment to Exenatide Manufacturing Agreement dated January 6, 2006, between Registrant and Mallinckrodt Inc.
  (33)(2)     10.38   Amended and Restated Commercial Supply Agreement dated April 1, 2008, between Registrant and Wockhardt UK (Holdings) Ltd.
  (33)(2)     10.39   Addendum to U.S. Co-Promotion Agreement dated May 8, 2008, between Registrant and Eli Lilly and Company
  (33)     10.40   Consulting Agreement dated June 1, 2008, between Registrant and Alain Baron
  (33)(2)     10.41   Third Amendment to Supply Agreement dated January 1, 2008, between Registrant and Mallinckrodt Inc.
  (5)     10.42   Amendment to Employment Agreement dated December 3, 2008, between Registrant and Daniel M. Bradbury †
        10.43   Exenatide Once Weekly Supply Agreement dated October 16, 2008, between Registrant and Eli Lilly and Company*
        10.44   Loan Agreement dated October 16, 2008, between Registrant and Eli Lilly and Company
        10.45   First Amendment to Credit Agreement dated October 27, 2008, among Registrant, the Bank of America, N.A. (as Administrative Agent) and other lenders set forth therein
        10.46   Amendment to Commercial Supply Agreement dated December 8, 2008, between Registrant and Baxter Pharmaceutical Solutions LLC*
        10.47   Amendment to the Amended and Restated Commercial Supply Agreement dated January 23, 2009, between Registrant and Wockhardt UK (Holdings) Ltd.*
        21.1   Subsidiaries of Registrant.
        23.1   Consent of Independent Registered Public Accounting Firm.
        24.1   Power of Attorney. Reference is made to page 71.
        31.1   Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
        31.2   Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
        32.1   Certifications Pursuant to U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Public Company Accounting Reform and Investor Protection Act of 2002.

Indicates management or compensatory plan or arrangement required to be identified pursuant to Item 15(c).

*
Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.

68


Table of Contents

(1)
Filed as an exhibit to the Registrant's Registration Statement on Form S-1 (No. 33-44195) or amendments thereto and incorporated herein by reference.

(2)
Confidential Treatment has been granted by the Securities and Exchange Commission with respect to portions of this agreement.

(3)
Filed as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1994, and incorporated herein by reference.

(4)
Filed as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1995, and incorporated herein by reference.

(5)
Filed as an exhibit on Form 8-K dated December 8, 2008, and incorporated herein by reference.

(6)
Filed as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 1996, and incorporated herein by reference.

(7)
Filed as an exhibit to the Registrant's Registration Statement on Form S-8 (No. 333-61660) or amendments thereto and incorporated herein by reference.

(8)
Filed as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2004, and incorporated herein by reference.

(9)
Filed as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 1998, and incorporated herein by reference.

(10)
Filed as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1998, and incorporated herein by reference.

(11)
Filed as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2001, and incorporated herein by reference.

(12)
Filed as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 1999, and incorporated herein by reference.

(13)
Filed as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2000, and incorporated herein by reference.

(14)
Filed as an exhibit on Form 8-K dated June 18, 2002, and incorporated herein by reference.

(15)
Filed as an exhibit on Form 8-K dated October 3, 2002, and incorporated herein by reference.

(16)
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2001, and incorporated herein by reference.

(17)
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2003, and incorporated herein by reference .

(18)
Filed as an exhibit to Amendment 1 to Registrant's Quarterly Report on Form 10-Q/A for the quarter ended June 30, 2003, and incorporated herein by reference .

(19)
Filed as an exhibit to Amendment 1 to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2003, and incorporated herein by reference.

(20)
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2002, and incorporated herein by reference.

(21)
Filed as an exhibit to Amendment 1 to Registrant's Annual Report on Form 10-K/A for the fiscal year ended December 31, 2003, and incorporated herein by reference.

69


Table of Contents

(22)
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2004, and incorporated herein by reference.

(23)
Filed on Form 8-K dated December 7, 2007, and incorporated herein by reference.

(24)
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2005, and incorporated herein by reference.

(25)
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2005, and incorporated herein by reference.

(26)
Filed as an exhibit on Form 8-K dated May 30, 2008 and incorporated herein by reference.

(27)
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2006, and incorporated herein by reference.

(28)
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2007, and incorporated herein by reference.

(29)
Filed as an exhibit on Form 8-K dated May 29, 2007, and incorporated herein by reference.

(30)
Filed as an exhibit on Form 8-K dated June 8, 2007, and incorporated herein by reference.

(31)
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2007, and incorporated herein by reference.

(32)
Filed as an exhibit to Registrant's Annual report on Form 10-K for the fiscal year ended December 31, 2007, and incorporated herein by reference.

(33)
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, and incorporated herein by reference.

70


Table of Contents


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.

    AMYLIN PHARMACEUTICALS, INC.

Date: February 27, 2009

 

 

 

 

 

 

By:

 

/s/ DANIEL M. BRADBURY

Daniel M. Bradbury,

President and Chief Executive Officer


POWER OF ATTORNEY

        KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Daniel M. Bradbury and Mark G. Foletta, and each of them, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place, and stead, in any and all capacities, to sign any and all amendments to this Report, and any other documents in connection therewith, and to file the same, with all exhibits thereto, 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 or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them or their or his substitute or substituted, 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.

Signatures
 
Title
 
Date

 

 

 

 

 

 

 
/s/ DANIEL M. BRADBURY

Daniel M. Bradbury
  President and Chief Executive Officer
(Principal Executive Officer)
  February 27, 2009

/s/ MARK G. FOLETTA  


Mark G. Foletta

 

Senior Vice President, Finance and Chief Financial Officer
(Principal Financial and Accounting Officer)

 

February 27, 2009

/s/ JOSEPH C. COOK, JR.

Joseph C. Cook, Jr.

 

Chairman of the Board

 

February 27, 2009

71


Table of Contents

Signatures
 
Title
 
Date

 

 

 

 

 

 

 
/s/ ADRIAN ADAMS

Adrian Adams
  Director   February 27, 2009

/s/ STEVEN R. ALTMAN

Steven R. Altman

 

Director

 

February 27, 2009

/s/ TERESA BECK

Teresa Beck

 

Director

 

February 27, 2009

/s/ KARIN EASTHAM

Karin Eastham

 

Director

 

February 27, 2009

/s/ JAMES R. GAVIN III, M.D., PHD.

James R. Gavin III, M.D., PhD.

 

Director

 

February 27, 2009

/s/ GINGER L. GRAHAM

Ginger L. Graham

 

Director

 

February 27, 2009

/s/ HOWARD E. GREENE, JR.

Howard E. Greene, Jr.

 

Director

 

February 27, 2009

/s/ JAY S. SKYLER, M.D.

Jay S. Skyler, M.D., MACP

 

Director

 

February 27, 2009

/s/ JOSEPH P. SULLIVAN

Joseph P. Sullivan

 

Director

 

February 27, 2009

/s/ JAMES N. WILSON

James N. Wilson

 

Director

 

February 27, 2009

72


Table of Contents


INDEX TO CONSOLIDATED FINANCIAL STATEMENTS


Table of Contents


Report of Independent Registered Public Accounting Firm

The Board of Directors and Stockholders of Amylin Pharmaceuticals, Inc.

        We have audited the accompanying consolidated balance sheets of Amylin Pharmaceuticals, Inc. as of December 31, 2008 and 2007, and the related consolidated statements of operations, stockholders' equity, and cash flows for each of the three years in the period ended December 31, 2008. Our audits also included the financial statement schedule listed in the Index at Item 15(a)(2). These financial statements and schedule are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements and schedule based on our audits.

        We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

        In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Amylin Pharmaceuticals, Inc., at December 31, 2008 and 2007, and the consolidated results of its operations and its cash flows for each of the three years in the period ended December 31, 2008, in conformity with U.S. generally accepted accounting principles. Also, in our opinion, the related financial statement schedule, when considered in relation to the basic financial statements taken as a whole, presents fairly, in all material respects, the information set forth therein.

        We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Amylin Pharmaceuticals, Inc's internal control over financial reporting as of December 31, 2008, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 23, 2009 expressed an unqualified opinion thereon.

    /S/ ERNST & YOUNG LLP

San Diego, California
February 23, 2009

F-1


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands, except per share data)

 
  December 31,  
 
  2008   2007  

ASSETS

 

Current assets:

             
 

Cash and cash equivalents

  $ 237,263   $ 422,232  
 

Short-term investments

    579,575     708,183  
 

Accounts receivable, net

    62,369     73,579  
 

Inventories, net

    115,823     100,214  
 

Other current assets

    41,038     32,100  
           

Total current assets

    1,036,068     1,336,308  

Property, plant and equipment, net

    636,922     390,301  

Other long-term assets

    23,755     28,082  

Debt issuance costs

    15,884     19,520  
           

  $ 1,712,629   $ 1,774,211  
           

LIABILITIES AND STOCKHOLDERS' EQUITY

       

Current liabilities:

             
 

Accounts payable

  $ 39,467   $ 37,530  
 

Accrued compensation

    65,145     56,428  
 

Payable to collaborative partner

    60,470     66,116  
 

Other current liabilities

    90,125     122,924  
 

Restructuring liability, current portion

    24,235      
 

Notes payable, current portion

    31,250      
 

Deferred revenue, current portion

    3,086     4,286  
           

Total current liabilities

    313,778     287,284  

Deferred revenue, net of current portion

        3,086  

Long-term deferred credit

    125,000      

Restructuring liability, net of current portion

    22,503      

Other long-term obligations, net of current portion

    31,724     31,023  

Notes payable, net of current portion

    93,750     125,000  

Convertible senior notes

    775,000     775,000  

Commitments and contingencies (Note 6)

             

Stockholders' equity:

             
 

Preferred stock, $.001 par value, 7,500 shares authorized, none issued and outstanding at December 31, 2008 and 2007

         
 

Common stock, $.001 par value, 450,000 shares authorized, 137,623 and 135,044 issued and outstanding at December 31, 2008 and 2007

    138     135  
 

Additional paid-in capital

    2,111,473     1,987,453  
 

Accumulated deficit

    (1,749,725 )   (1,434,320 )
 

Accumulated other comprehensive loss

    (11,012 )   (450 )
           

Total stockholders' equity

    350,874     552,818  
           

  $ 1,712,629   $ 1,774,211  
           

See accompanying notes to consolidated financial statements.

F-2


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

 
  Year ended December 31,  
 
  2008   2007   2006  

Revenues:

                   
 

Net product sales

  $ 765,342   $ 701,450   $ 474,038  
 

Revenues under collaborative agreements

    74,767     79,547     36,837  
               

Total revenues

    840,109     780,997     510,875  

Costs and expenses:

                   
 

Cost of goods sold

    91,596     65,457     50,073  
 

Selling, general and administrative

    395,112     390,982     281,950  
 

Research and development

    293,095     276,600     222,053  
 

Collaborative profit-sharing

    302,600     290,934     194,191  
 

Restructuring

    54,926          
               

Total costs and expenses

    1,137,329     1,023,973     748,267  
               

Operating loss

    (297,220 )   (242,976 )   (237,392 )

Make-whole payment on debt redemption

            (7,875 )

Interest and other income

    26,561     46,969     34,903  

Interest and other expense

    (29,803 )   (15,129 )   (8,492 )

Loss on impairment of investments

    (14,943 )        
               

Net loss

  $ (315,405 ) $ (211,136 ) $ (218,856 )
               

Net loss per share—basic and diluted

  $ (2.30 ) $ (1.59 ) $ (1.78 )
               

Shares used in computing net loss per share, basic and diluted

    137,006     132,621     122,647  
               

See accompanying notes to consolidated financial statements.

F-3


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY

For the years ended December 31, 2008, 2007 and 2006

(in thousands)

 
  Common stock    
   
  Accumulated
other
comprehensive
(loss) income
   
 
 
  Additional
paid-in capital
  Accumulated
deficit
  Total
stockholders'
equity
 
 
  Shares   Amount  

Balance at December 31, 2005

    110,531   $ 111   $ 1,073,948   $ (1,004,328 ) $ (467 ) $ 69,264  

Comprehensive loss:

                                     

Net loss

                (218,856 )       (218,856 )

Unrealized gain on available-for-sale securities

                    1,618     1,618  
                                     

Comprehensive loss

                                  (217,238 )

Issuance of common stock upon exercise of options, net

    2,405     2     31,635             31,637  

Issuance of common stock for other employee benefit plans

    457         10,296             10,296  

Employee stock-based compensation

            51,485             51,485  

Issuance of common stock for restricted stock awards

    8         353             353  

Conversion of convertible senior notes, net of debt issuance costs

    5,377     5     172,972             172,977  

Issuance of common stock for make-whole payment

    180         7,875             7,875  

Issuance of common stock in public offering, net

    11,500     12     507,518             507,530  

Non-employee stock-based compensation

            1,112             1,112  
                           

Balance at December 31, 2006

    130,458     130     1,857,194     (1,223,184 )   1,151     635,291  

Comprehensive loss:

                                     

Net loss

                (211,136 )       (211,136 )

Unrealized loss on available-for-sale securities

                    (1,601 )   (1,601 )
                                     

Comprehensive loss

                                  (212,737 )

Issuance of common stock upon exercise of options, net

    2,547     3     37,396             37,399  

Issuance of common stock upon exercise of warrants

    1,604     2     18,370             18,372  

Issuance of common stock for other employee benefit plans

    435         14,735             14,735  

Employee stock-based compensation

            59,064             59,064  

Non-employee stock-based compensation

            694             694  
                           

Balance at December 31, 2007

    135,044     135     1,987,453     (1,434,320 )   (450 )   552,818  

Comprehensive loss:

                                     

Net loss

                (315,405 )       (315,405 )

Unrealized loss on available-for-sale securities

                    (10,562 )   (10,562 )
                                     

Comprehensive loss

                                  (325,967 )

Issuance of common stock upon exercise of options, net

    528         7,260             7,260  

Issuance of common stock upon milestone conversion

    790     1     29,999             30,000  

Issuance of common stock for other employee benefit plans

    578     1     13,717             13,718  

Issuance of common stock for employee stock ownership plan

    683     1     16,995             16,996  

Employee stock-based compensation

            55,901             55,901  

Non-employee stock-based compensation

            148             148  
                           

Balance at December 31, 2008

    137,623   $ 138   $ 2,111,473   $ (1,749,725 ) $ (11,012 ) $ 350,874  
                           

See accompanying notes to consolidated financial statements.

F-4


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

 
  Years ended December 31,  
 
  2008   2007   2006  

Operating activities:

                   

Net loss

  $ (315,405 ) $ (211,136 ) $ (218,856 )

Adjustments to reconcile net loss to net cash used in operating activities:

                   
 

Depreciation and amortization

    33,348     21,563     16,228  
 

Stock-settled compensation accruals

    25,109     21,696     5,869  
 

Employee stock-based compensation

    55,115     59,064     51,838  
 

Loss on impairment of investments

    14,943          
 

Restructuring (including $786 of employee stock-based compensation)

    9,483          
 

Make-whole payment on debt redemption

            7,875  
 

Other non-cash expenses

    5,718     3,028     1,247  

Changes in operating assets and liabilities:

                   
 

Accounts receivable, net

    11,210     (15,490 )   (32,389 )
 

Inventories, net

    (15,609 )   (40,915 )   (32,549 )
 

Other current assets

    (13,005 )   (10,016 )   (3,995 )
 

Accounts payable and accrued liabilities

    8,641     28,101     38,293  
 

Accrued compensation

    4,888     1,300     7,071  
 

Payable to collaborative partner

    (5,646 )   13,778     35,660  
 

Deferred revenue

    111,498     (4,286 )   (4,286 )
 

Deferred collaborative profit sharing

    9,216          
 

Restructuring liabilities

    46,738          
 

Other assets and liabilities, net

    (5,752 )   8,153     1,987  
               

Net cash used in operating activities

    (19,510 )   (125,160 )   (126,007 )

Investing activities:

                   

Purchases of short-term investments

    (1,015,811 )   (392,155 )   (714,772 )

Sales and maturities of short-term investments

    1,132,017     383,076     386,840  

Purchases of property, plant and equipment

    (295,060 )   (268,674 )   (97,925 )

Increase in other long-term assets

    (3,299 )   (18,348 )   (33 )
               

Net cash used in investing activities

    (182,153 )   (296,101 )   (425,890 )

Financing activities:

                   

Proceeds from issuance of common stock, net

    16,694     64,687     546,511  

Proceeds from issuance of convertible debt, net

        558,670      

Proceeds from long-term note payable

        123,496      

Proceeds from contingent share settled obligation

        30,000      

Principal payments on capital leases

             
               

Net cash provided by financing activities

    16,694     776,853     546,511  
               

Increase (decrease) in cash and cash equivalents

    (184,969 )   355,592     (5,386 )

Cash and cash equivalents at beginning of year

    422,232     66,640     72,026  
               

Cash and cash equivalents at end of year

  $ 237,263   $ 422,232   $ 66,640  
               

Supplemental disclosures of cash flow information:

                   

Interest paid, net of interest capitalized

  $ 17,701   $ 9,477   $ 6,409  

Interest capitalized

  $ 11,867   $ 4,483   $ 560  

Property, plant and equipment additions in other current liabilities at year end

  $ 6,057   $ 15,559   $ 21,219  

Common stock issued upon conversion of senior convertible notes

  $   $   $ 175,000  

Reclassification of debt issuance costs to additional paid-in capital upon conversion of convertible senior notes

  $   $   $ 1,980  

Non-cash financing activities:

                   

Issuance of common stock upon milestone conversion

  $ 30,000   $   $  

Shares contributed as employer 401(k) match

  $ 4,284   $ 5,819   $ 2,811  

Issuance of common stock for employee stock ownership plan

  $ 16,996   $   $  

See accompanying notes to consolidated financial statements.

F-5


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1. Summary of Significant Accounting Policies

Organization

        Amylin Pharmaceuticals, Inc., referred to as the Company or Amylin, was incorporated in Delaware on September 29, 1987. Amylin is a biopharmaceutical company engaged in the discovery, development and commercialization of drug candidates for the treatment of diabetes, obesity and other diseases.

Principles of Consolidation

        The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Amylin Ohio, LLC, and Amylin Investments, LLC. All significant intercompany transactions and balances have been eliminated in consolidation.

Use of Estimates

        The preparation of the consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

Revenue Recognition

Net Product Sales

        The Company sells BYETTA® (exenatide) injection for the treatment of type 2 diabetes and SYMLIN® (pramlintide acetate) injection for the treatment of type 1 and type 2 diabetes primarily to wholesale distributors, who, in turn, sell to retail pharmacies and government entities. Product sales are recognized when delivery of the products has occurred, title has passed to the customer, the selling price is fixed or determinable, collectability is reasonably assured and the Company has no further obligations. The Company records allowances for product returns, rebates, wholesaler chargebacks, wholesaler discounts, and prescription vouchers at the time of sale and reports product sales net of such allowances. The Company must make significant judgments in determining these allowances. If actual results differ from the Company's estimates, the Company will be required to make adjustments to these allowances in the future.

        The Company records all United States BYETTA and SYMLIN product sales. With respect to BYETTA, the Company has determined that it is qualified as a principal under the criteria set forth in Emerging Issues Task Force (EITF), Issue 99-19, "Reporting Gross Revenue as a Principal vs. Net as an Agent," based on the Company's responsibilities under its contracts with Eli Lilly and Company, or Lilly, which include manufacture of product for sale in the United States, responsibility for establishing pricing in the United States, distribution, ownership of product inventory and credit risk from customers.

Revenues Under Collaborative Agreements

        Amounts received for upfront product and technology license fees under multiple-element arrangements are deferred and recognized over the period of such services or performance if such arrangements require on-going services or performance. Non-refundable amounts received for

F-6


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

1. Summary of Significant Accounting Policies (Continued)


substantive milestones are recognized upon achievement of the milestone. Amounts received for sharing of development expenses are recognized in the period in which the related expenses are incurred. Any amounts received prior to satisfying these revenue recognition criteria are recorded as deferred revenue.

Collaborative Profit-Sharing

        Collaborative profit-sharing represents Lilly's 50% share of the gross margin for Byetta sales in the United States (see Note 4).

Shipping and Handling Costs

        Shipping and handling costs incurred for product shipments are included in cost of goods sold in the accompanying consolidated statements of operations.

Research and Development Expenses

        Research and development costs are expensed as incurred and include salaries and bonuses, benefits, non-cash stock-based compensation, license fees, milestones under license agreements, costs paid to third-party contractors to perform research, conduct clinical trials, and develop drug materials and delivery devices; and associated overhead expenses and facilities costs. Clinical trial costs, including costs associated with third-party contractors, are a significant component of research and development expenses. Invoicing from third-party contractors for services performed can lag several months. The Company accrues the costs of services rendered in connection with such activities based on its estimate of management fees, site management and monitoring costs, and data management costs. Actual clinical trial costs may differ from estimates and are adjusted in the period in which they become known.

Concentrations of Risk

        The Company relies on third-party manufacturers for the production of its products and drug candidates. If the Company's third-party manufacturers are unable to continue manufacturing its products and/or drug candidates, or if the Company loses one of its sole source suppliers used in its manufacturing processes, the Company may not be able to meet market demand for its products and could be materially and adversely affected.

        Lilly provides funding for 50% of the development and commercialization expenses for BYETTA and exenatide once weekly and 55% of exenatide once weekly manufacturing development expenses in the United States pursuant to a global development and commercialization agreement between the parties. Lilly co-promotes the product with the Company in the United States and manufactures pen devices for the administration of BYETTA. If Lilly is unable to perform these activities the Company may be unable to meet market demand for its products and could be materially and adversely affected.

        The Company is also subject to credit risk from its accounts receivable related to product sales. The Company sells its products in the United States primarily to wholesale distributors. The top four of the Company's customers represented approximately 95% of net product sales in 2008 and 95% of the accounts receivable balance at December 31, 2008. The Company evaluates the credit worthiness of its

F-7


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

1. Summary of Significant Accounting Policies (Continued)


customers and generally does not require collateral. The Company has not experienced any material losses on uncollectible accounts receivable to date.

        Net product sales for the years ended December 31, 2008, 2007 and 2006 were $765.3 million, $701.5 million and $474.0 million, respectively, and consisted of sales of BYETTA and SYMLIN, less allowances for product returns, rebates and wholesaler chargebacks, wholesaler discounts, and prescription vouchers.

        The following table provides information regarding net product sales by product (in millions):

 
  Year ended December 31,  
 
  2008   2007   2006  

BYETTA

  $ 678.5   $ 636.0   $ 430.2  

SYMLIN

    86.8     65.5     43.8  
               

  $ 765.3   $ 701.5   $ 474.0  
               

        Three of the Company's customers each accounted for more than 10% of total revenues for the year ended December 31, 2008, and two of the Company's customers each accounted for more than 10% of total revenues for the years ended December 31, 2007 and 2006, respectively. The following table summarizes the percent of the Company's total revenues that were attributed to each of these three customers (as a % of total revenues):

 
  Year ended December 31,  
 
  2008   2007   2006  

Medco Health Solutions

    11 %   *     *  

McKesson Corporation

    35 %   37 %   36 %

Cardinal Health, Inc. 

    33 %   32 %   34 %

      *
      Less than 10%

        The Company invests its excess cash in U.S. Government securities, securities of agencies sponsored by the U.S. Government, asset-backed securities, mortgage-backed securities, and debt instruments of financial institutions and corporations with investment-grade credit ratings. The Company has established guidelines relative to diversification and maturities that maintain safety and liquidity. The primary goal of these guidelines is to safeguard principal and they are periodically reviewed. These guidelines prohibit investments in auction rate securities. Financial instruments that potentially subject the Company to significant credit risk consist principally of cash equivalents and short-term investments.

Cash and Cash Equivalents

        The Company considers instruments with a maturity date of less than 90 days from the date of purchase to be cash equivalents. Cash and cash equivalents include certificates of deposits underlying letters of credit and cash collateral for derivative financial instruments of $3.5 million at December 31, 2008 and 2007, respectively.

F-8


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

1. Summary of Significant Accounting Policies (Continued)

Fair Value Measurements

        Statement of Financial Accounting Standards (SFAS) No. 157, "Fair Value Measurements," provides a framework for measuring fair value and requires expanded disclosures regarding fair value measurements. SFAS No. 157 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Market participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. SFAS No. 157 prioritizes the inputs used in measuring fair value into the following hierarchy:

Level 1   Quoted prices (unadjusted) in active markets for identical assets or liabilities;

Level 2

 

Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable; and

Level 3

 

Unobservable inputs in which little or no market activity exists, therefore requiring an entity to develop its own assumptions about the assumptions that market participants would use in pricing.

Short-Term Investments

        The Company's short-term investments, consisting principally of debt securities, are classified as available-for-sale and are stated at fair value based upon observed market prices (Level 1 in the fair value hierarchy). Unrealized holding gains or losses on these securities are included in other comprehensive loss. The amortized cost of debt securities in this category is adjusted for amortization of premiums and accretion of discounts to maturity. For investments in mortgage-backed securities, amortization of premiums and accretion of discounts are recognized in interest income using the interest method, adjusted for anticipated prepayments as applicable. Estimates of expected cash flows are updated periodically and changes are recognized in the calculated effective yield prospectively as appropriate. Such amortization is included in interest income. Realized gains and losses and declines in value judged to be other-than-temporary on available-for-sale securities are included in impairment loss on investments. In assessing potential impairment of its short-term investments, the Company evaluates the impact of interest rates, potential prepayments on mortgage-backed securities, changes in credit quality, the length of time and extent to which the market value has been less than cost, and the Company's intent and ability to retain the security in order to allow for an anticipated recovery in fair value. The cost of securities sold is based on the specific-identification method.

Accounts Receivable

        Trade accounts receivable are recorded net of allowances for cash discounts for prompt payment, doubtful accounts, product returns and chargebacks. Allowances for rebate discounts and distribution fees are included in other current liabilities in the accompanying consolidated balance sheets. Estimates for allowances for doubtful accounts are determined based on existing contractual obligations, historical payment patterns and individual customer circumstances. The allowance for doubtful accounts was $0.6 million and $0.2 million at December 31, 2008 and December 31, 2007, respectively.

F-9


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

1. Summary of Significant Accounting Policies (Continued)

Inventories, net

        Inventories are stated at the lower of cost (FIFO) or market and net of a valuation allowance for potential excess and/or obsolete material of $5.1 million and $5.3 million at December 31, 2008 and December 31, 2007, respectively. Raw materials consists of bulk drug material for BYETTA and SYMLIN, work-in-process consists of in-process BYETTA cartridges, in-process SYMLIN cartridges and in-process SYMLIN vials, and finished goods consists of BYETTA drug product in a disposable pen/cartridge delivery system, finished SYMLIN drug product in vials for syringe administration and finished SYMLIN drug product in a disposable pen/cartridge delivery system.

Property, plant and Equipment

        Property, plant and equipment, consists of construction in process, leasehold improvements, computer software, office equipment and furniture, laboratory equipment, production equipment, land, and building and is recorded at cost. Depreciation of software and equipment is computed using the straight-line method, over three to fifteen years. Leasehold improvements are amortized on a straight-line basis over the shorter of the estimated useful lives of the assets or the remaining term of the lease. Depreciation of buildings is computed using the straight-line method, over fifteen or thirty years. Construction in progress includes costs associated with the Company's manufacturing facility for exenatide once weekly, which is currently under construction in Ohio (see Note 4). The Company recorded depreciation expense of $29.2 million, $19.0 million, and $14.3 million in the years ended December 31, 2008, 2007 and 2006, respectively.

        The Company records impairment losses on property, plant and equipment used in operations when events and circumstances indicate that assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. The Company also records the assets to be disposed of at the lower of their carrying amount or fair value less cost to sell. For the year ended December 31, 2008, the Company recorded $8.8 million in asset impairments related to impaired leasehold improvements associated with facility leases the Company will no longer use in its operations as part of its restructuring discussed in Note 5. While the Company's current and historical operating and cash flow losses are indicators of impairment, the Company believes the future cash flows to be received support the carrying value of its long-lived assets and accordingly, the Company has not recognized any impairment losses, with the exception of those discussed above, as of December 31, 2008.

        FDA validation costs, which to date relate to the Company's manufacturing facility for exenatide once weekly, are capitalized as part of the effort required to acquire and construct long-lived assets, including readying them for their initial intended use, and are amortized over the estimated useful life of the asset.

Computer Software Costs for Internal Use

        The Company records the costs of computer software for internal use in accordance with AICPA Statement of Position (SOP) 98-1, "Accounting for the Costs of Computer Software Developed or Obtained for Internal Use." SOP 98-1 requires that certain internal-use computer software costs be capitalized. Capitalized costs are amortized on a straight-line basis over the estimated useful life of software, generally three years and included in depreciation expense.

F-10


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

1. Summary of Significant Accounting Policies (Continued)

Investments in Unconsolidated Entities

        The Company uses the equity method of accounting for investments in other companies that are not controlled by the Company and in which the Company's interest is generally between 20% and 50% of the voting shares or the Company has significant influence over the entity, or both. The Company's share of the income or losses of these entities are included in interest and other expense, and the investments, which have a net book value of $4.7 million and $15.7 million at December 31, 2008 and December 31, 2007, respectively, are included in other long-term assets. The Company recorded $4.5 million and $1.8 million of equity method investee losses during the years ended December 31, 2008 and 2007, respectively. The Company recognized an impairment loss of $9.0 million in 2008 on one of its equity method investments after assessing the financial and technical performance of the entity in which the investment was made as well as the entity's ability to raise additional capital in significantly deteriorated financial markets to fund ongoing operations.

Patents

        The Company has filed a number of patent applications with the United States Patent and Trademark Office and in foreign countries. Certain legal and related costs incurred in connection with pending patent applications have been capitalized. Costs related to successful patent applications are amortized over the lesser of the remaining useful life of the related technology or the remaining patent life, commencing on the date the patent is issued. Gross capitalized patent costs were approximately $5.5 million and $4.9 million at December 31, 2008 and 2007, respectively. Accumulated amortization was approximately $2.6 million and $2.2 million at December 31, 2008 and 2007, respectively. Patents are classified as other long-term assets in the accompanying consolidated balance sheets. The Company recorded patent amortization expense of $0.4 million in the year ended December 31, 2008, and $0.3 million in each of the years ended December 31, 2007 and 2006. Capitalized costs related to patent applications are expensed as a selling, general and administrative expense in the period during which a determination not to pursue such applications is made. Such expenses were not material in the years ended December 31, 2008, 2007 and 2006, respectively.

Net Loss Per Share

        Basic and diluted net loss applicable to common stock per share is computed using the weighted average number of common shares outstanding during the period. Common stock equivalents from stock options and warrants of approximately 3.0 million, 6.8 million and 8.0 million were excluded from the calculation of net loss per share for the years ended December 31, 2008, 2007 and 2006, respectively, because the effect would be antidilutive. In addition, common stock equivalents from shares underlying the Company's convertible senior notes of 15.2 million, 11.1 million, and 5.8 million were excluded from the net loss per share for the years ended December 31, 2008, 2007 and 2006, respectively, because the effect would be antidilutive. In future periods, if the Company reports net income and the common share equivalents for the Company's convertible senior notes are dilutive, the common stock equivalents will be included in the weighted average shares computation and interest expense related to the notes will be added back to net income to calculate diluted earnings per share.

F-11


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

1. Summary of Significant Accounting Policies (Continued)

Derivative Financial Instruments

        The Company mitigates certain financial exposures, including currency risk and interest rate risk, through a controlled program of risk management that includes the use of derivative financial instruments. Derivatives are recorded on the balance sheet at fair value, with changes in value being recorded in interest and other income and interest and other expense. The fair value of the Company's derivative financial instruments was a net liability of $4.8 million and $0.4 million at December 31, 2008 and 2007, respectively. The Company has determined that its derivative financial instruments are defined as Level 2 in the fair value hierarchy. The Company recognized unrealized losses on derivative financial instruments of $4.9 million and $0.1 million for the years ended December 31, 2008 and 2007, respectively. The Company did not have any derivative financial instruments for the year ended December 31, 2006.

Comprehensive Loss

        SFAS No. 130, "Reporting Comprehensive Income" requires that all components of comprehensive loss be reported in the financial statements in the period in which they are recognized. Comprehensive income is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net loss and other comprehensive loss, including unrealized gains and losses on investments, shall be reported, net of their related tax effect, to arrive at comprehensive loss.

Accounting for Stock-Based Compensation

        Effective January 1, 2006, the Company adopted the fair value method of accounting for stock-based compensation arrangements in accordance with Financial Accounting Standards Board (FASB) SFAS No. 123R, "Share-Based Payment," which establishes accounting for non-cash, stock-based awards exchanged for employee services and requires companies to expense the estimated fair value of these awards over the requisite employee service period, which for the Company is generally the vesting period. The Company adopted SFAS No. 123R using the modified prospective method. Under the modified prospective method, prior periods are not revised for comparative purposes. The valuation provisions of SFAS No. 123R apply to new awards and to awards that are outstanding on the effective date and subsequently modified or cancelled. Estimated non-cash, compensation expense for awards outstanding at the effective date will be recognized over the remaining service period using the compensation cost calculated for pro-forma disclosure purposes under SFAS No. 123, "Accounting for Stock-Based Compensation."

        The Company uses the Black-Scholes model to estimate the value of non-cash, stock-based payments granted to employees under SFAS No. 123R.

        The weighted-average estimated fair value of employee stock options and employee stock purchase rights granted during the year ended December 31, 2008 was $10.43 and $7.14 per share, respectively, and the weighted-average estimated fair value of employee stock options and employee stock purchase

F-12


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

1. Summary of Significant Accounting Policies (Continued)


rights granted during the year ended December 31, 2007 was $18.01 and $10.01 per share, respectively using the following weighted-average assumptions:

 
  Years ended December 31,  
 
  2008   2007   2006  

Stock option plans

                   
 

Volatility

    46.5 %   44.2 %   52.4 %
 

Expected life in years

    4.2     5.4     5.4  
 

Risk-free interest rate

    3.4 %   4.7 %   4.8 %
 

Dividend yield

    %   %   %

Employee stock purchase plan

                   
 

Volatility

    56.8 %   27.9 %   43.2 %
 

Expected life in years

    0.5     0.5     0.5  
 

Risk-free interest rate

    1.9 %   4.9 %   4.9 %
 

Dividend yield

    %   %   %

        The Company estimates volatility based upon the historical volatility of its common stock for a period corresponding to the expected term of its employee stock options and the implied volatility of market-traded options on its common stock with various maturities between six months and two years, consistent with the guidance in SFAS No. 123R and the Securities and Exchange Commission's Staff Accounting Bulletin (SAB) No. 107. The determination to use implied volatility in addition to historical volatility was based upon the availability of actively traded options on the Company's common stock and the Company's assessment that the addition of implied volatility is more representative of future stock price trends than historical volatility alone.

        The expected life of the Company's employee stock options represents the weighted-average period of time that options granted are expected to be outstanding in consideration of historical exercise patterns and the assumption that all outstanding options will be exercised at the mid-point of the then current date and their maximum contractual term.

        The risk-free interest rates are based on the yield curve of U.S. Treasury strip securities in effect at the time of grant for periods corresponding with the expected life of the Company's employee stock options. The Company has never paid dividends and does not anticipate doing so for the foreseeable future. Accordingly, the Company has assumed no dividend yield for purposes of estimating the fair value of its stock-based payments to employees.

        Stock-based compensation expense recognized in accordance with SFAS No. 123R is based on awards ultimately expected to vest, and therefore is reduced by expected forfeitures. The Company estimates forfeitures based upon historical forfeiture rates, and will adjust its estimate of forfeitures if actual forfeitures differ, or are expected to differ, from such estimates. Changes in estimated forfeitures will be recognized through a cumulative adjustment in the period of the change and will also impact the amount of stock-based compensation expense in future periods

        The Company recorded $55.9 million, or $0.41 per share, and $59.1 million, or $0.45 per share, and $51.8 million, or $0.42 per share, of total employee non-cash, stock-based compensation expense for the years ended December 31, 2008, 2007 and 2006, respectively, as required by the provisions of

F-13


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

1. Summary of Significant Accounting Policies (Continued)


SFAS No. 123R. Stock-based compensation expense capitalized as part of inventory and fixed assets was negligible and there was no impact on the Company's reported cash flows for the years ended December 31, 2008 and 2007. The breakdown of total employee non-cash, stock-based compensation expense by operating statement classification is presented below (in thousands):

 
  Year ended December 31,  
 
  2008   2007   2006  

Selling, general and administrative expenses

  $ 33,977   $ 35,420   $ 28,966  

Research and development expenses

    21,138     23,644     22,872  

Restructuring

    786          
               

  $ 55,901   $ 59,064   $ 51,838  
               

        In addition to the stock-based compensation discussed above, the Company also recorded $20.2 million and $17.3 million of expense associated with its Employee Stock Ownership Plan, or ESOP, for the years ended December 31, 2008 and 2007, respectively. There was no expense for the ESOP in 2006 as the plan was not adopted until 2007. The breakdown of non-cash ESOP expense by operating statement classification is presented below (in thousands):

 
  Year ended December 31,  
 
  2008   2007  

Selling, general and administrative expenses

  $ 11,267   $ 10,022  

Research and development expenses

    8,529     7,269  

Restructuring

    417      
           

  $ 20,213   $ 17,291  
           

Recently Issued Accounting Standards

        In May 2008, the FASB issued FASB Staff Position , or FSP, No. APB 14-1, "Accounting for Convertible Debt Instruments that may be Settled in Cash Upon Conversion (Including Partial Cash Settlement)." FSP No. APB 14-1 establishes that the liability and equity components of convertible debt instruments within the scope of FSP APB No. 14-1 shall be separately accounted for in a manner that will reflect the entity's nonconvertible debt borrowing rate when interest cost is recognized in subsequent periods. The carrying amount of the liability component of the convertible debt instrument will be determined by measuring the fair value of a similar liability that does not have an associated equity component. The carrying value of the equity component will be determined by deducting the fair value of the liability component from the initial proceeds ascribed to the convertible debt instrument as a whole. Related transaction costs shall be allocated to the liability and equity components in proportion to the allocation of proceeds and accounted for as debt issuance costs and equity issuance costs, respectively. The excess of the principal amount of the liability component over its carrying amount shall be amortized to interest cost using the interest method. FSP No. APB 14-1 is effective for the Company on January 1, 2009 and shall be applied retrospectively to all periods presented with the cumulative effect of the change in accounting principle on periods prior to those presented recognized as of the beginning of the first period presented. Early adoption is not permitted. The Company

F-14


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

1. Summary of Significant Accounting Policies (Continued)


expects that the adoption of FSP No. APB 14-1 will have a material impact on interest expense reported in its consolidated financial statements.

        In March 2008, the FASB issued SFAS No. 161, "Disclosures about Derivative Instruments and Hedging Activities, an amendment of FASB Statement No. 133," which requires additional disclosures about the objectives of using derivative instruments, the method by which the derivative instruments and related hedged items are accounted for under FASB Statement No.133 and its related interpretations, and the effect of derivative instruments and related hedged items on financial position, financial performance and cash flows. SFAS No. 161 also requires disclosure of the fair values of derivative instruments and their gains and losses in a tabular format. SFAS No. 161 will be effective for the Company on January 1, 2009. The Company does not expect that the adoption of SFAS No. 161 will have a material impact on its consolidated financial statement disclosures.

        In December 2007, the FASB issued SFAS No. 141 (revised 2007), or SFAS No. 141R, "Business Combinations" and SFAS No. 160, "Noncontrolling Interests in Consolidated Financial Statements, an amendment of Accounting Research Bulletin No. 51." SFAS 141R will change how business acquisitions are accounted for and will impact financial statements both on the acquisition date and in subsequent periods. SFAS No. 160 will change the accounting and reporting for minority interests, which will be recharacterized as noncontrolling interests and classified as a component of equity. SFAS No. 141R and SFAS No. 160 are effective for the Company on January 1, 2009. Early adoption is not permitted. The Company does not expect that the adoption of SFAS No. 141R and SFAS No. 160 will have a material impact on its consolidated financial statements, but will change the manner in which potential future acquisitions and direct costs of acquisitions are reported.

        In December 2007, the FASB ratified the consensuses reached in Emerging Issue Task Force, or EITF, Issue No. 07-1, "Collaborative Arrangements". EITF Issue No. 07-1 defines collaborative arrangements and establishes reporting requirements for transactions between participants in a collaborative arrangement and between participants in the arrangements and third parties. Under EITF Issue No. 07-1, payments between participants pursuant to a collaborative arrangement that are within the scope of other authoritative accounting literature on income statement classification should be accounted for using the relevant provisions of that literature. If the payments are not within the scope of other authoritative accounting literature, the income statement classification for the payments should be based on an analogy to authoritative accounting literature or if there is no appropriate analogy, a reasonable, rational, and consistently applied accounting policy election. EITF Issue No. 07-1 also provides disclosure requirements and is effective for the Company on January 1, 2009. The effect of applying EITF Issue No. 07-1 will be reported as a change in accounting principle through retrospective applications to all prior periods presented for all collaborative arrangements existing as of the effective date, unless it is impracticable. The Company does not expect that the impact that the adoption of EITF Issue No. 07-1 will have a material impact on its consolidated financial statements.

F-15


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

2. Investments

        The following is a summary of short-term investments as of December 31, 2008 and 2007 (in thousands):

 
  Available-for-Sale Securities  
 
  Amortized
Cost
  Gross
Unrealized
Gains(1)
  Gross
Unrealized
Losses(1)
  Estimated
Fair Value
 

December 31, 2008

                         

U.S. Treasury securities

  $ 130,193   $ 449   $   $ 130,642  

Obligations of U.S. Government-sponsored enterprises

    129,197     656     (1,494 )   128,359  

Corporate debt securities

    294,805     175     (4,090 )   290,890  

Asset backed securities

    33,081     4     (3,401 )   29,684  
                   

Total

  $ 587,276   $ 1,284   $ (8,985 ) $ 579,575  
                   

December 31, 2007

                         

U.S. Treasury securities

  $ 80,282   $ 385   $ (19 ) $ 80,648  

Obligations of U.S. Government-sponsored enterprises

    82,640     441     (141 )   82,940  

Corporate debt securities

    408,020     101     (1,576 )   406,545  

Asset backed securities

    138,447     258     (655 )   138,050  
                   

Total

  $ 709,389   $ 1,185   $ (2,391 ) $ 708,183  
                   

(1)
Other comprehensive loss included an unrealized loss of $3.3 million and an unrealized gain of $0.8 million on investments underlying the Company's 2001 Non-Qualified Deferred Compensation Plan at December 31, 2008 and 2007, respectively.

        The gross realized gains on sales of available-for-sale securities totaled approximately $2.6 million, $1.1 million and $0.6 million and the gross realized losses totaled $4.6 million, $0.8 million and $0.8 million for the years ended December 31, 2008, 2007 and 2006, respectively.

        Contractual maturities of short-term investments at December 31, 2008 were as follows (in thousands):

 
  Fair Value  

Due within 1 year

  $ 430,768  

After 1 but within 5 years

    111,387  

After 5 but within 10 years

    6,191  

After 10 years

    31,229  
       

Total

  $ 579,575  
       

        For purposes of these maturity classifications, the final maturity date is used for securities not due at a single maturity date which, for the Company, includes asset-backed and mortgage-backed securities that are included in Obligations of U.S Government-sponsored enterprises in the table above.

        The following table shows the gross unrealized losses and fair value of the Company's investments with unrealized losses that are not deemed to be other-than-temporarily impaired, aggregated by

F-16


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

2. Investments (Continued)


investment category and length of time that individual securities have been in a continuous unrealized loss position, at December 31, 2008 (in thousands):

 
  Less then 12 Months   12 Months or Greater   Total  
 
  Fair Value   Unrealized
Losses
  Fair Value   Unrealized
Losses
  Fair Value   Unrealized
Losses
 

U.S. Treasury securities

  $   $   $   $   $   $  

Obligations of U.S Government-sponsored enterprises

    22,741     (38 )           22,741     (38 )

Corporate debt securities

    69,235     (756 )   72,995     (3,334 )   142,230     (4,090 )

Asset backed securities

    7,628     (76 )   19,225     (3,325 )   26,853     (3,401 )

Mortgage-backed securities

    6,513     (560 )   23,779     (896 )   30,292     (1,456 )
                           

  $ 106,117   $ (1,430 ) $ 115,999   $ (7,555 ) $ 222,116   $ (8,985 )
                           

        The Company recognized a $5.9 million other-than-temporary impairment loss on an investment in a corporate debt security in the quarter ended September 30, 2008 based upon an assessment of the impact of bankruptcy proceedings of the debt issuer on the recoverability of the Company's investment. The Company determined the fair value of this investment using the quoted market price (Level 1 in the fair value hierarchy) of the security at September 30, 2008. The unrealized losses on the Company's remaining investments is due to the increased volatility in the markets impacting the classes of securities the Company invests in and not a deterioration in credit ratings. The Company's investments have a short effective duration, and since the Company has the ability and intent to hold these investments until a recovery of fair value, which may be maturity, the Company does not consider these investments to be other-than-temporarily impaired at December 31, 2008.

3. Other Financial Information

        Inventories consist of the following (in thousands):

 
  At December 31,  
 
  2008   2007  

Raw materials

  $ 74,140   $ 55,706  

Work-in process

    21,382     24,463  

Finished goods

    20,301     20,045  
           

  $ 115,823   $ 100,214  
           

        Other current assets consist of the following (in thousands):

 
  At December 31,  
 
  2008   2007  

Prepaid expenses

  $ 30,335   $ 15,787  

Interest and other receivables

    3,681     5,831  

Other current assets

    7,022     10,482  
           

  $ 41,038   $ 32,100  
           

F-17


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

3. Other Financial Information (Continued)

        Property, plant and equipment consist of the following (in thousands):

 
  At December 31,  
 
  2008   2007  

Land

  $ 8,886   $ 7,768  

Land improvements

    2,990      

Office equipment and furniture

    36,579     30,680  

Computer software

    46,273     37,988  

Laboratory equipment

    34,275     29,985  

Production equipment

    13,610     11,528  

Leasehold improvements

    71,379     58,977  

Building

    51,278     1,150  

Construction in progress

    455,603     260,746  
           

    720,873     438,822  

Less accumulated depreciation and amortization

    (83,951 )   (48,521 )
           

  $ 636,922   $ 390,301  
           

        Other current liabilities consist of the following (in thousands):

 
  At December 31,  
 
  2008   2007  

Contingent share-settled obligation(1)

  $   $ 30,000  

Accrued research and development contract services

    9,400     20,107  

Accrued rebate discounts

    28,575     19,673  

Accrued property, plant and equipment additions

    6,057     15,559  

Other accrued sales allowances

    12,011     13,989  

Other current liabilities

    34,082     23,596  
           

  $ 90,125   $ 122,924  
           

      (1)
      Represents a liability for $30 million in milestone payments received from Lilly that were convertible into the Company's common stock at December 31, 2007 (see to note 4).

4. Collaborative Agreements

Collaboration with Eli Lilly and Company

        In September 2002, the Company and Lilly entered into a collaboration agreement for the global development and commercialization of exenatide. The agreement was amended in 2006.

        This agreement includes BYETTA and any sustained release formulations of exenatide such as once weekly exenatide, the Company's once-weekly formulation of exenatide for the treatment of type 2 diabetes. Under the terms of the agreement, operating profits from products sold in the United States are shared equally between Lilly and us. In 2005, the Company received United States Food and Drug Administration (FDA) approval for the twice-daily formulation of exenatide, which is marketed in

F-18


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

4. Collaborative Agreements (Continued)


the United States under the trade name BYETTA. The agreement provides for tiered royalties payable to us by Lilly based upon the annual gross margin for all exenatide product sales, including any long-acting release formulations, outside of the United States. Royalty payments for exenatide product sales outside of the United States will commence after a one-time cumulative gross margin threshold amount has been met. Lilly is responsible for 100% of the costs related to development of twice-daily BYETTA for sale outside of the United States. Development costs related to all other exenatide products for sale outside of the United States are allocated 80% to Lilly and 20% to us. Lilly is responsible for 100% of the costs related to commercialization of all exenatide products for sale outside of the United States.

        At signing, Lilly made initial non-refundable payments to the Company totaling $80 million, of which $50 million was amortized to revenues under collaborative agreements prior to 2004. The remaining $30 million is being amortized to revenues ratably over a seven-year period, which represents the Company's estimate of the period of its performance of significant development activities under the agreement.

        In addition to these up-front payments, Lilly agreed to make future milestone payments of up to $85 million upon the achievement of certain development milestones, including milestones relating to both twice daily and sustained release formulations of exenatide such as exenatide once weekly, of which $75 million have been paid through December 31, 2008. No additional development milestones may be earned under the collaboration agreement. In December 2007, the Company received milestone payments of $30 million associated with the results of a thirty week comparator study of exenatide once weekly and BYETTA in patients with type 2 diabetes. Since the New Drug Application filing for exenatide once weekly did not occur by December 31, 2007, Lilly was entitled to and in February 2008 elected to convert the milestones into shares of the Company's common stock. The milestones were converted into 0.8 million shares of the Company's common stock in February 2008 at a conversion price equal to $37.9535, the immediately preceding twenty day average closing market price of the Company's common stock on December 31, 2007.

        Lilly also agreed to make additional future milestone payments of up to $130 million contingent upon the commercial launch of exenatide in selected territories throughout the world, including both twice-daily and sustained release formulations, of which $40 million have been paid and recorded as revenue through December 31, 2008.

        In May 2008, the Company and Lilly amended their United States co-promotion agreement, resulting in a 40% increase in the total number of sales representatives promoting BYETTA beginning July 1, 2008. To achieve this increase, Lilly's existing third-party sales force for Cialis co-promotes BYETTA in the United States and the Company increased the number of sales representatives in its primary care sales force by approximately 15%. In exchange for Lilly sharing in 50% of the costs related to the Company's additional sales representatives and paying 100% of the third party sales force discussed above, the Company's primary care sales force co-promotes Cialis in the United States. The Company is currently evaluating this element of the co-promotion arrangement with Lilly.

        In October 2008, the Company and Lilly entered into an Exenatide Once Weekly Supply Agreement pursuant to which the Company will supply commercial quantities of exenatide once weekly for sale in the United States, if approved by the United States Food and Drug Administration, or FDA. In addition, if Lilly receives approval to market the product in jurisdictions outside the United States,

F-19


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

4. Collaborative Agreements (Continued)


the Company will be required to manufacture the product intended for commercial sale by Lilly in those jurisdictions

        Under the terms of the supply agreement, Lilly made a cash payment of $125 million to the Company, which represents an amount to compensate the Company for the cost of carrying Lilly's share of the capital investment made in the Company's manufacturing facility in Ohio. Under the terms of the supply agreement, the Company has agreed not to charge Lilly for Lilly's share of the interest costs capitalized to the facility. Accordingly the Company has determined that a portion of the $125 million payment represents a reimbursement to the Company of Lilly's share of interest costs capitalized to the facility that will be credited to Lilly for its share of the capitalized interest included in the cost of goods sold for exenatide once weekly as incurred. The Company has concluded that any excess amount represents deferred collaborative revenue that will be amortized ratably over the economic useful life of the exenatide once weekly product following its commercial launch. The ultimate allocation of the $125 million payment, which is classified as a long-term deferred credit in the accompanying Consolidated Balance Sheets at December 31, 2008, will be dependent upon the total amount of interest costs capitalized to the facility when it is placed in service. Under certain circumstances, including upon an impairment of the exenatide once weekly manufacturing facility, Lilly may receive a credit for the unearned portion of the $125 million payment which will be applied against Lilly's share of the impairment charge.

        In addition to the $125 million cash payment, the Company will recover Lilly's share of the over $500 million capital investment in the facility through an allocation of depreciation to cost of goods sold in accordance with the collaboration agreement. The total amount of the capital investment that will ultimately be recovered from Lilly will be dependent upon the proportion of product supplied for sale in the United States, the cost of which is shared equally by the parties, and the proportion of product supplied for sale outside of the United States, the cost of which is paid for 100% by Lilly.

        In October 2008, the Company and Lilly also entered into a loan agreement pursuant to which Lilly will make available to Amylin a $165 million unsecured line of credit that Amylin can draw upon from time to time beginning on December 1, 2009 and ending on June 30, 2011. Any interest due under the credit facility will bear interest at the five-day average three-month LIBOR rate immediately prior to the date of the advance plus 5.25% and shall be due and payable quarterly in arrears on the first business day of each quarter. All outstanding principal, together with all accrued and unpaid interest shall be due and payable the earlier of 36 months following the date on which the loan commitment is fully advanced or June 30, 2014.

F-20


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

4. Collaborative Agreements (Continued)

        The following table summarizes the milestones received to date and the manner of recognition in the accompanying consolidated financial statements:

Amount
  Year
Received
  Milestone event   Manner of recognition   Type

$30 million

    2003  

Completion of Phase 3 clinical trials for BYETTA.

 

Recognized as revenue under collaborative agreements upon receipt.

  Development

$5 million

   
2003
 

Completion of Phase 3 clinical trials for BYETTA.

 

Deferred upon receipt and recognized as revenue under collaborative agreements in 2005 following contents of approved label for BYETTA.

 

Development

$5 million

   
2004
 

Results of clinical study comparing BYETTA to insulin-glargine.

 

Recognized as revenue under collaborative agreements upon filing of BYETTA New Drug Application in 2004.

 

Development

$30 million

   
2005
 

Regulatory approval and commercial launch of BYETTA.

 

Recognized as revenue under collaborative agreements upon commercial launch of BYETTA in 2005.

 

Commercial

$5 million

   
2007
 

Results of clinical study comparing BYETTA to insulin-glargine.

 

Recognized as revenue under collaborative agreements upon receipt.

 

Development

$10 million

   
2007
 

Commercial launch of BYETTA in the EU.

 

Recognized as revenue under collaborative agreements upon commercial launch of BYETTA in 2007.

 

Commercial

$30 million

   
2007
 

Completion of Phase 3 trial for once weekly exenatide.

 

Deferred upon receipt until stock conversion rights contingency finalized.(1)

 

Development


(1)
In February 2008, Lilly elected to convert these milestones into shares of the Company's common stock.

        The Company recorded revenue under this collaborative agreement of $69.3 million, $78.8 million and $36.8 million in the years ended December 31, 2008, 2007 and 2006, respectively, and incurred reimbursable development expenses of $135.0 million, $100.5 million and $74.7 million in the years ended December 31, 2008, 2007 and 2006, respectively.

F-21


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

4. Collaborative Agreements (Continued)

        Reimbursable development expenses consist of direct internal and external expenses for exenatide, including both BYETTA and sustained release formulations.

Collaboration with Alkermes, Inc.

        In May 2000, the Company signed an agreement with Alkermes, Inc., a company specializing in the development of products based on proprietary drug delivery technologies, for the development, manufacture and commercialization of an injectable long-acting formulation of exenatide, or exenatide once weekly.

        Under the terms of the agreement, Alkermes has granted the Company an exclusive, worldwide license to its Medisorb® technology for the development and commercialization of injectable sustained release formulations of exendins, such as exenatide, and other related compounds that Amylin may develop. In exchange, Alkermes receives funding for research and development and may earn future milestone payments upon achieving specified development and commercialization goals. Alkermes will also receive royalties on any future product sales.

        In October 2005, the Company and Alkermes Controlled Therapeutics II, a wholly owned subsidiary of Alkermes, Inc., entered into an Amendment to Development and License Agreement (the "Amendment"), which amends the Development and License Agreement between the parties dated May 15, 2000. Under the terms of the Amendment, the Company will be responsible for manufacturing for commercial sale the once weekly dosing formulation of exenatide once weekly, if approved. The royalty to be paid from the Company to Alkermes for commercial sales of exenatide once weekly was adjusted to reflect the new manufacturing arrangement.

        In December 2005, the Company's wholly-owned subsidiary, Amylin Ohio LLC, purchased an existing building and land to house the Company's manufacturing facility in Ohio and the Company is responsible for all costs and expenses associated with the design, construction, validation and utilization of the facility. At December 31, 2008 the Company had capitalized $522.5 million associated with the construction of this facility, which is expected to be completed in 2009.

Other Collaborations

        In connection with its strategic equity investments, the Company has entered into collaborative agreements with certain of its equity method investees. Collaborative revenues associated with these agreements were $1.2 million and $0.7 million for the years ended December 31, 2008 and 2007, respectively. There were no collaborative revenues associated with these agreements in 2006.

5. Restructuring

        On November 10, 2008, the Company announced a corporate restructuring, ("the Restructuring") that reduced its San Diego work force by approximately 25 percent or 330 employees. The Company has substantially completed all of the activities included in the restructuring plan and all of the costs associated with the restructuring were incurred during the year ended December 31, 2008.

        In connection with the Restructuring, the Company recorded restructuring charges of $54.9 million which are reported as a separate line item in the accompanying Consolidated Statement of Operations

F-22


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

5. Restructuring (Continued)


for the year ended December 31, 2008. The following table summarizes the components of the restructuring charges (in thousands):

 
  Year ended December 31, 2008  
 
  Accruals   Non-cash items   Total  

Facilities related charges

  $ 38,447   $ (7,156 ) $ 31,291  

Employee separation costs

    13,118     786     13,904  

Asset impairments

        8,796     8,796  

Other restructuring charges

    935         935  
               

  $ 52,500   $ 2,426   $ 54,926  
               

        Facility related charges consist of estimated losses associated with certain facility leases in the Company's San Diego campus that the Company will no longer use in its operations and which the Company ceased using in the quarter ended December 31, 2008. These losses represent the remaining lease payments and other costs due under the lease and costs associated with obtaining sub-leases, net of sub-lease income under executed sub-leases, or to the extent sub-leases have not yet been signed, reasonably expected sub-lease income determined based upon the Company's assessment of market conditions for similar rental properties in its geographic area both of which are discounted at a credit-adjusted risk-free rate of 10%. As of December 31, 2008, the Company had an executed sub-lease for the entire term of its lease obligations for two of the facilities. These two facilities accounted for approximately $15.3 million of the total facility related charges of $31.3 million. The Company expects to incur approximately $12.7 million of accretion expense over the term of the leases, which have expiration dates from 2014 to 2018.

        Employee separation costs consist primarily of salaries and benefits earned during the minimum notification period proscribed by law and severance costs associated with the reduction in the Company's San Diego workforce. Asset impairments primarily relate to impaired leasehold improvements associated with the facility leases discussed above. Other restructuring charges consist of incremental direct costs associated with the Restructuring.

        The following table sets forth activity in the restructuring liability (in thousands):

 
  Employee
separation costs
  Facilities
related charges
  Other restructuring
charges
  Total  

Balance at December 31, 2007

  $   $   $   $  

Accruals

    13,118     38,447     935     52,500  

Payments

    (4,827 )       (935 )   (5,762 )
                   

Balance at December 31, 2008

  $ 8,291   $ 38,447   $   $ 46,738  
                   

        The Company records restructuring activities in accordance with FASB Statement No. 144, Accounting for the Impairment and Disposal of Long-Lived Assets and FASB Statement No. 146, Accounting for Costs Associated with Exit or Disposal Activities.

F-23


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

6. Commitments and Contingencies

Lease Commitments

        The Company leases its facilities under operating leases, with various terms, the majority of which expire between 2015 and 2019. The minimum annual rent on the Company's facilities is subject to increases based on stated rental adjustment terms of certain leases, taxes, insurance and operating costs. For financial reporting purposes, rent expense is recognized on a straight-line basis over the term of the leases. Accordingly, rent expense recognized in excess of rent paid is reflected as deferred rent. Deferred rent totaled $8.3 million and $9.8 million at December 31, 2008 and 2007, respectively, of which $7.6 million and $8.7 million is included in other long-term obligations, net of current portion in the accompanying Consolidated Balance Sheets at December 31, 2008 and 2007, respectively. Certain of the Company's facility leases contain incentives in the form of reimbursement from the landlord for a portion of the costs of leasehold improvements incurred by the Company. These incentives are recognized as a reduction of rental expense on a straight-line basis over the term of the respective leases. Unamortized leasehold improvement incentives totaled $9.0 million and $14.0 million at December 31, 2008 and 2007, respectively, of which $7.9 million and $12.5 million is included in other long-term obligations, net of current portion in the accompanying consolidated balance sheets at December 31, 2008 and 2007, respectively.

        The Company leases vehicles for its field force under operating leases, with lease terms up to four years, of which the first year is non-cancellable. Minimum future payments for the non-cancellable term of these leases are $1.0. million at December 31, 2008.

        Minimum future annual obligations for facility and vehicle operating leases for years ending after December 31, 2008 are as follows (in thousands):

2009

  $ 23,422  

2010

    23,138  

2011

    23,790  

2012

    24,430  

2013

    25,055  

Thereafter

    91,027  
       

Total minimum lease payments

  $ 210,862  
       

        Rent expense for the years ended December 31, 2008, 2007 and 2006, was $18.9 million, $16.2 million and $9.8 million, respectively.

Other Commitments

        The Company has committed to make potential future milestone payments to third parties as part of in-licensing and development programs primarily related to research and development agreements. Potential future payments generally become due and payable only upon the achievement of certain developmental, regulatory and/or commercial milestones, such as achievement of regulatory approval, successful development and commercialization of products, and subsequent product sales. Because the achievement of these milestones is neither probable nor reasonably estimable, the Company has not recorded a liability on the balance sheet for any such contingencies.

F-24


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

6. Commitments and Contingencies (Continued)

        As of December 31, 2008, if all such milestones are successfully achieved, the potential future milestone and other contingency payments due under certain contractual agreements are approximately $303.4 million in aggregate, of which $1.8 million is expected to be paid over the next twelve months.

        The Company has committed to make future minimum payments to third parties for certain inventories in the normal course of business. The minimum contractual purchase commitments total $341.9 million as of December 31, 2008, the majority of which relate to exenatide once weekly and BYETTA, including minimum inventory purchases for exenatide once weekly of $311.8 million that are contingent upon FDA approval of exenatide once weekly.

        As of December 31, 2008, commitments to complete construction of the Company's exenatide once weekly manufacturing facility in Ohio are $38.9 million.

7. Convertible Senior Notes

        In April 2004, the Company issued $200 million aggregate principal amount of 2.5% convertible senior notes due April 15, 2011 in a private placement, referred to as the 2004 Notes. The 2004 Notes have been registered under the Securities Act of 1933, as amended, or the Securities Act, to permit registered resale of the 2004 Notes and of the common stock issuable upon conversion of the 2004 Notes. The 2004 Notes bear interest at 2.5% per year, payable in cash semi-annually and are convertible into a total of up to 5.8 million shares of common stock at a conversion price of $34.35 per share, subject to customary adjustments for stock dividends and other dilutive transactions. The Company incurred debt issuance costs of $6.4 million in connection with the issuance of the 2004 Notes, which are being amortized to interest expense over the term of the 2004 Notes and had a net book value of $2.1 million and $3.0 million at December 31, 2008 and 2007, respectively. Amortization expense associated with these debt issuance costs were approximately $0.9 million for each of the years ended December 31, 2008, 2007 and 2006. The fair value of the 2004 Notes, determined by observed market prices, was $150.0 million and $249.9 million at December 31, 2008 and 2007, respectively.

        Upon a change in control, the holders of the 2004 Notes may elect to require the Company to re-purchase the 2004 Notes. The Company may elect to pay the purchase price in common stock instead of cash, or a combination thereof. If paid with common stock the number of shares of common stock a holder will receive will be valued at 95% of the average closing prices of the Company's common stock for the five-day trading period ending on the third trading day before the purchase date.

        In June 2007, the Company issued the 2007 Notes in a private placement, which have an aggregate principal amount of $575 million, and are due June 15, 2014. The 2007 Notes are senior unsecured obligations and rank equally with all other existing and future senior unsecured debt. The 2007 Notes bear interest at 3.0% per year, payable in cash semi-annually, and are initially convertible into a total of up to 9.4 million shares of common stock at a conversion price of $61.07 per share, subject to the customary adjustment for stock dividends and other dilutive transactions. In addition, if a "fundamental change" (as defined in the associated indenture agreement) occurs prior to the maturity date, the Company will in some cases increase the conversion rate for a holder of notes that elects to convert its notes in connection with such fundamental change. The maximum conversion rate is 22.9252, which would result in a maximum issuance 13.2 million shares of common stock if all holders converted at the maximum conversion rate.

F-25


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

7. Convertible Senior Notes (Continued)

        The 2007 Notes will be convertible into shares of the Company's common stock unless the Company elects net-share settlement. If net-share settlement is elected by the Company, the Company will satisfy the accreted value of the obligation in cash and will satisfy the excess of conversion value over the accreted value in shares of the Company's common stock based on a daily conversion value, determined in accordance with the associated indenture agreement, calculated on a proportionate basis for each day of the relevant 20-day observation period. Holders may convert the 2007 Notes only in the following circumstances and to the following extent: (1) during the five business-day period after any five consecutive trading period (the measurement period) in which the trading price per note for each day of such measurement period was less than 97% of the product of the last reported sale price of the Company's common stock and the conversion rate on each such day; (2) during any calendar quarter after the calendar quarter ending March 31, 2007, if the last reported sale price of the Company's common stock for 20 or more trading days in a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter exceeds 130% of the applicable conversion price in effect on the last trading day of the immediately preceding calendar quarter; (3) upon the occurrence of specified events; and (4) the 2007 Notes will be convertible at any time on or after April 15, 2014 through the scheduled trading day immediately preceding the maturity date.

        Subject to certain exceptions, if the Company undergoes a "designated event" (as defined in the associated indenture agreement) including a "fundamental change,", including if a majority of the Company's Board of Directors ceases to be composed of the of the existing directors or other individuals approved by a majority of the existing directors, holders of the 2007 Notes will, for the duration of the notes, have the option to require the Company to repurchase all or any portion of their 2007 Notes. The designated event repurchase price will be 100% of the principal amount of the 2007 Notes to be purchased plus any accrued interest up to but excluding the relevant repurchase date. The Company will pay cash for all notes so repurchased. The Company may not redeem the Notes prior to maturity.

        The 2007 Notes have been registered under the Securities Act of 1933, as amended, to permit registered resale of the 2007 Notes and of the common stock issuable upon conversion of the 2007 Notes. Subject to certain limitations, the Company will be required to pay the holders of the 2007 Notes special interest on the 2007 Notes if the Company fails to keep such registration statement effective during specified time periods. The 2007 Notes pay interest in cash, semi-annually in arrears on June 15 and December 15 of each year, which began on December 15, 2007. The Company incurred debt issuance costs of $16.3 million in connection with the issuance of the 2007 Notes, which are being amortized to interest expense over the term of the 2007 Notes and had a net book value of $12.7 million and $15.0 million at December 31, 2008 and 2007, respectively. Amortization expense associated with these debt issuance costs was $2.3 million and $1.3 million in the years ended December 31, 2008 and 2007, respectively. The fair value of the 2007 Notes, determined by observed market prices, was $260.4 and $549.3 million at December 31, 2008 and 2007 respectively.

        The Company capitalized $11.7 million, $4.5 million and $0.6 million of interest expense for the years ended December 31, 2008, 2007 and 2006, respectively, associated with construction in progress.

8. Redemption of Convertible Senior Notes

        In June and July 2003, the Company issued $175 million of 2.25% convertible senior notes due June 30, 2008 in a private placement referred to as the 2003 Notes. The 2003 Notes were convertible

F-26


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

8. Redemption of Convertible Senior Notes (Continued)


into a total of up to 5.4 million shares of common stock at a conversion price of approximately $32.55 per share. The 2003 notes were provisionally redeemable in whole or in part, at the Company's option at any time on or after June 30, 2006, upon the satisfaction of certain conditions, at specified redemption prices plus accrued interest. The Company called the notes for redemption in July 2006 and issued approximately 5.4 million shares of its common stock to note holders upon the conversion of all of the outstanding 2003 Notes in August 2006. In connection with the conversion, the Company also issued 180,005 shares as a make-whole payment, representing $112.94 per $1,000 principal value of the converted 2003 Notes less interest actually paid. The Company recorded as a one-time, non-cash, non-operating charge of $7.9 million for the make-whole payment in the quarter ended September 30, 2006. Debt issuance costs of $5.3 million were incurred in connection with the issuance of the 2003 Notes and were being amortized to interest expense on a straight-line basis over the contractual term of the 2003 Notes. Amortization expense associated with these debt issuance costs were $0.7 million in the year ended December 31, 2006. Upon conversion, the $2.0 million unamortized balance of these related debt issuance costs were reclassified to additional paid-in capital.

9. Long-Term Note Payable

        In December 2007, the Company entered into a $140 million credit agreement with Bank of America, N.A., as administrative agent, collateral agent and letter of credit issuer, Silicon Valley Bank and RBS Asset Finance, Inc., as syndication agents, and Comerica Bank and BMO Capital Markets Financing, Inc., as documentation agents. The credit agreement provides for a $125 million term loan and a $15 million revolving credit facility. The revolving credit facility also provides for the issuance of letters of credit and foreign exchange hedging up to the $15 million borrowing limit. At December 31, 2008 the Company had an outstanding balance of $125.0 million under the term loan and had issued $5.6 million of standby letters of credit under the revolving credit facility, primarily in connection with office leases.

        The Company's domestic subsidiaries, Amylin Ohio LLC and Amylin Investments LLC, are co-borrowers under the credit agreement. The loans under the revolving credit facility are collateralized by substantially all of the Company's and the two domestic subsidiaries' assets (other than intellectual property and certain other excluded collateral). The term loan is repayable on a quarterly basis, with no payments due quarters one through four, 6.25% of the outstanding principal due quarters five through eleven, and 56.25% of the outstanding principal due in quarter 12. Interest on the term loan will be paid quarterly on the unpaid principal balance at 1.75% above the London Interbank Offered Rate, or LIBOR, based on the Company's election of either one, two, three, or six months LIBOR term, and payable at the end of the selected interest period but no less frequently than quarterly as of the first business day of the quarter prior to the period in which the quarterly installment is due. The Company has elected to use the three month LIBOR, which was 1.44% at December 31, 2008. Interest periods on the revolving credit facility may be either one, two, three, or six months, and payable at the end of the selected interest period but no less frequently than quarterly, and the interest rate will be either LIBOR plus 1.0% or the Bank of America prime rate, as selected by the Company. Both loans have a final maturity date of December 21, 2010.

        The credit agreement contains certain covenants, including a requirement to maintain minimum unrestricted cash and cash equivalents balances, as defined in the agreement, in excess of $400 million, below which certain limitations provided for in the agreement become effective. The credit agreement also contains certain events of default including unrestricted cash and cash equivalents balances, as

F-27


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

9. Long-Term Note Payable (Continued)


defined in the agreement, falling below $280 million, nonpayment of principal, interest, fees or other amounts, violation of covenants, inaccuracy of representations and warranties and default under other indebtedness that would permit the administrative agent to accelerate the Company's outstanding obligations if not cured within applicable grace periods. In addition, the credit agreement provides for automatic acceleration upon the occurrence of bankruptcy, other insolvency events and a change in control as defined in the credit agreement, including if a majority of the Company's Board of Directors ceases to be composed of the of the existing directors or other individuals approved by a majority of the existing directors. There is an annual commitment fee associated with the revolving credit facility of 0.25%.

        Maturities of long-term debt for years ending after December 31, 2008 are as follows (in thousands):

2009

  $ 31,250  

2010

    93,750  

Thereafter

     
       

Total minimum long-term debt payments

  $ 125,000  
       

        The Company incurred debt issuance costs of $1.7 million in connection with the credit agreement, which are being amortized to interest expense on a straight-line basis over the term of the credit agreement and had a net book value of $1.1 million and $1.5 million at December 31, 2008 and 2007, respectively. Amortization expense associated with these debt issuance costs was $0.6 million and $15.3 thousand in the years ended December 31, 2008 and 2007, respectively.

        In connection with the execution of the Term Loan, the Company entered into an interest rate swap with an initial notional amount of $125 million on December 21, 2007 that has resulted in a fixed rate of 5.717% and matures on December 12, 2010. The Company determined that the interest rate swap agreement is defined as Level 2 in the fair value hierarchy. As of December 31, 2008, the fair value of the interest rate swap agreement was a liability of $5.0 million and the recognized loss on the interest rate swap, which is included in interest and other expense, was $4.6 million and $0.4 million for the years ended December 31, 2008 and 2007, respectively.

10. Stockholders' Equity

Stock-based Compensation Plans

    Stock Option Plans

        The Company has two stock option plans under which it currently grants stock options: the 2001 Equity Incentive Plan, or the 2001 Plan, which replaced the 1991 Stock Option Plan, or the 1991 Plan, upon the 1991 Plan's expiration in October 2001, and the 2003 Non-Employee Directors' Stock Option Plan, or the 2003 Directors' Plan. Under the 2003 Directors' Plan, non-qualified stock options and restricted stock may be granted to non-employee directors of the Company. The 2003 Directors' Plan provides for automatic stock option grants to non-employee directors upon their initial appointment or election to the Company's Board of Directors and are issued from shares authorized under the 2001 Plan. Options granted under the 1991 Plan remain outstanding until exercised or cancelled.

F-28


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

10. Stockholders' Equity (Continued)

        To date, stock-based compensation awards under the 1991 Plan, the 2001 Plan and the 2003 Directors' Plan consist primarily of incentive and non-qualified stock options. Stock options granted under the 2001 Plan and the 2003 Directors' Plan must have an exercise price equal to at least 100% of the fair market value of the Company's common stock on the date of grant, have a maximum contractual term of 10 years and generally vest over four years. At December 31, 2008, an aggregate of 24.2 million shares were reserved for future issuance under the Company's stock option plans, of which 5.6 million shares were available for future grants.

        A summary of stock option transactions for all stock option plans is presented below:

 
  Shares
(thousands)
  Weighted-Average
Exercise Price
  Weighted-
Average
Remaining
Contractual
Term (years)
  Aggregate Intrinsic
Value (thousands)
 

Options outstanding at December 31, 2007

    17,167   $ 27.67              

Granted

    2,924   $ 25.44              

Exercised

    (528 ) $ 13.76              

Cancelled/Forfeited

    (958 ) $ 33.97              
                         

Options outstanding at December 31, 2008

    18,605   $ 27.39     5.47   $ 3,033  
                         

Options exercisable at December 31, 2008

   
12,496
 
$

25.08
   
5.01
 
$

3,000
 
                         

Options vested and expected to vest

   
17,720
 
$

27.11
   
5.41
 
$

3,029
 
                         

        The total intrinsic value of stock options exercised was $8.4 million, $72.9 million and $74.8 million during the years ended December 31, 2008, 2007 and 2006, respectively. The Company received cash from the exercise of stock options of $7.3 million, $37.4 million, and $31.6 million during the years ended December 31, 2008, 2007 and 2006, respectively. The Company did not record any tax benefits related to the exercise of employee stock options due to its net loss position. Upon option exercise, the Company issues new shares of its common stock.

        At December 31, 2008, total unrecognized estimated non-cash, stock-based compensation expense related to nonvested stock options granted prior to that date was $78.5 million, with a weighted-average amortization period of 2.2 years. The Company records non-cash, stock-based compensation expense for options with pro-rata vesting on a straight-line basis over the awards' vesting period.

    Employee Stock Purchase Plan

        The Company's 2001 Employee Stock Purchase Plan, or the 2001 Purchase Plan, enables participants to contribute up to 15% of their eligible compensation for the purchase of the Company's common stock at the lower of 85% of the fair market value of the Company's common stock (i) on the employee's enrollment date or (ii) the purchase date. The terms of any offerings under the 2001 Purchase Plan are established by the Compensation and Human Resources Committee of the Board of Directors. In May 2008, the Compensation and Human Resources Committee approved a series of four consecutive six-month offerings commencing on September 1, 2008. At December 31, 2008, 0.9 million shares were reserved for future issuance under the 2001 Purchase Plan.

F-29


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

10. Stockholders' Equity (Continued)

        The total intrinsic value of purchase rights exercised was $1.7 million, $1.5 million and $10.4 million during the years ended December 31, 2008, 2007 and 2006, respectively. At December 31, 2008, total unrecognized non-cash, compensation expense for nonvested purchase rights granted prior to that date was $0.7 million, with a weighted-average amortization period of 0.2 years.

Shares Reserved for Future Issuance

        The following shares of common stock are reserved for future issuance at December 31, 2008 (in thousands):

Stock Option Plans

    24,188  

Employee Stock Purchase Plan

    950  

Directors' Deferred Compensation Plan

    4  

401(k) Plan

    104  

Convertible Senior Notes

    15,238  
       

    40,484  
       

Issuance of Common Stock

        In April 2006, the Company completed a public offering of 11.5 million shares of its common stock at a price of $46.50 per share. This transaction generated net proceeds of approximately $508 million for the Company and was completed pursuant to a shelf registration statement filed with Securities and Exchange Commission in March 2006.

Shareholder Rights Plan

        In June 2002, the Company adopted a Preferred Share Purchase Rights Plan (the "Rights Plan"). The Rights Plan provides for a dividend distribution of one preferred stock purchase right (a "Right") for each outstanding share of the Company's common stock, par value $0.001 per share, held of record at the close of business on June 28, 2002. The Rights are not currently exercisable. Under certain conditions involving an acquisition or proposed acquisition by any person or group of 15% or more of the Company's common stock, the Rights permit the holders (other than the 15% holder) to purchase one one-hundredth of a share of Series A Junior Participating Preferred Stock, par value $0.001 per share (the "Preferred Shares") at a price of $100 per one one-hundredth of a Preferred Share, subject to adjustment. Each one one-hundredth of a share of Preferred Shares has designations and powers, preferences and rights and the qualifications, limitations and restrictions which make its value approximately equal to the value of one share of the Company's common stock. Under certain conditions, the Rights are redeemable by the Company's Board of Directors in whole, but not in part, at a price of $0.001 per Right.

11. Benefit Plans

Defined Contribution 401(k) Plan

        The Company has a defined contribution 401(k) plan for the benefit of all eligible employees. Discretionary matching contributions are based on a percentage of employee contributions and are funded by newly issued shares of the Company's common stock. The Company recorded expense of

F-30


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

11. Benefit Plans (Continued)


$5.1 million, $4.4 million and $6.0 million for matching contributions in the years ended December 31, 2008, 2007 and 2006, respectively.

Deferred Compensation Plans

        In August 1997, the Company adopted a Non-Employee Directors' Deferred Compensation Plan (the "Directors' Deferral Plan") that permits participating non-employee directors to elect, on an annual basis, to defer all or a portion of their cash compensation in a deferred stock account, pursuant to which the deferred fees are credited in the form of phantom shares of the Company's common stock, based on the market price of the stock at the time the fees are earned. Deferred amounts are valued at the fair market value of the Company's common stock at each reporting date and are included in accrued compensation in the accompanying consolidated balance sheets. Upon termination of service the director's account is settled in either cash or stock, at the Company's discretion. The Company recorded a credit associated with this plan of $0.6 million for the year ended December 31, 2008, and recorded an expense associated with this plan of $0.8 million and $0.1 million for the years ended December 31, 2007 and 2006, respectively.

        The Company adopted a Deferred Compensation Plan in April 2001, which allows officers and directors to defer up to 100% of their annual compensation. The trust assets, consisting of primarily cash, mutual funds and equity securities are recorded at current market prices. The company-owned assets are placed in a "rabbi trust" and are included in other current assets in the accompanying consolidated balance sheets. The trust assets had a fair value of $6.5 million and $9.3 million at December 31, 2008 and 2007, respectively, including unrealized losses of approximately $3.3 million at December 31, 2008 and unrealized gains of approximately $0.8 million at December 31, 2007. Unrealized gains and losses on the trust assets are included in accumulated other comprehensive loss in the accompanying consolidated balance sheets. The corresponding liability was $6.5 million and $9.3 million at December 31, 2008 and 2007, respectively, of which $6.3 million and $8.6 million are included in other long-term liabilities, net of current portion in the accompanying consolidated balance sheets at December 31, 2008 and 2007, respectively. The current portion of the corresponding liability is included in accrued compensation in the accompanying consolidated balance sheets at December 31, 2008 and 2007. Total contributions to this plan, consisting solely of compensation deferred by participants, were $1.7 million, $3.0 million and $1.0 million for the years ended December 31, 2008, 2007 and 2006, respectively.

Employee Stock Ownership Plan

        In December 2007, the Company adopted the ESOP. Active employees who are at least 18 years old and have met minimum service requirements are eligible to participate. Each participant has an account with the ESOP, in which mandatory contributions of 10% of a participant's eligible compensation are made by the Company. The Company may make discretionary contributions for any plan year, and contributions are limited to the lesser of 100% of a participant's plan year compensation and limitations established by the Internal Revenue Service Code (IRS Code). A participant's compensation primarily includes wages and bonus.

        Any cash dividends paid with respect to shares of the Company's stock allocated to a participant's account may be used to purchase new shares of the Company's stock, paid by the Company directly in cash to participants on a non-discriminatory basis. Any stock dividends paid with respect to shares of

F-31


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

11. Benefit Plans (Continued)


the Company's stock allocated to a participant's account will be held and distributed in the same manner as the shares of the Company's stock to which such stock dividend applies.

        Participants vest in their accounts over four years of service, at 25% for more than one year of service but less than two years, at 50% for more than two years of service but less than three years, at 75% for more than three years of service but less than four years, and 100% for more than four years of service. Any forfeitures of non-vested amounts shall be used to restore any rehired employees who previously forfeited their nonvested balance under certain circumstances, or shall be used to reduce future employer contributions and shall be allocated to the participant accounts. Distributions are made upon termination of employment, when a participant is age 55 and has at least ten years of participation in the ESOP, when the participant is seventy and one-half and is not a five percent owner or the year after a participant is seventy and one-half and is a five percent owner, upon termination of the ESOP, and as necessary by regulatory requirements.

        Shares committed to be released or that have been allocated to participant accounts are treated as outstanding shares for calculating earnings per share. The ESOP held 0.7 million shares at December 31, 2008, of which 0.4 million were unvested. The Company recorded ESOP expense of $20.2 million and $17.0 million at December 31, 2008 and 2007, respectively, for the Company's contribution, which is included in other current liabilities in the accompanying consolidated balance sheets.

12. Litigation

        From time-to-time the Company becomes involved in various lawsuits, claims and proceedings relating to the conduct of our business, including those pertaining to product liability, patent infringement and employment claims. For example, the Company is currently involved in seven product liability cases, four of which have been stayed pending the U.S. Supreme Court's decision on federal preemption of such cases in Wyeth v. Levine. The Company has also been notified of additional claimants who may file product liability complaints. While the Company cannot predict the outcome of any lawsuit, claim or proceeding, the Company believes that the disposition of any current lawsuits is not likely to have a material effect on our financial condition or liquidity.

13. Income Taxes

        We have net deferred tax assets relating primarily to net operating loss carry forwards and research and development tax credit carryforwards. Subject to certain limitations, these deferred tax assets may be used to offset taxable income in future periods. Since we have been unprofitable since inception and the likelihood of future profitability is not assured, we have reserved for most of these deferred tax assets in our consolidated balance sheets at December 31, 2008 and 2007, respectively. If we determine that we are able to realize a portion or all of these deferred tax assets in the future, we will record an adjustment to increase their recorded value and a corresponding adjustment to increase income or additional paid in capital, as appropriate, in that same period.

        In July 2006, the FASB issued Interpretation No. 48 (FIN 48) "Accounting for Uncertainty in Income TaxesAn Interpretation of FASB Statement No. 109." FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an entity's financial statements in accordance with SFAS No. 109 and prescribes a recognition threshold and measurement attributes for financial statement disclosure of tax positions taken or expected to be taken on a tax return. Under FIN 48, the impact of

F-32


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

13. Income Taxes (Continued)


an uncertain income tax position on the income tax return must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Additionally, FIN 48 provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition.

        We adopted the provisions of FASB Interpretation No. 48 and FSP FIN 48-1 effective January 1, 2007. FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise's financial statements in accordance with SFAS No. 109, "Accounting for Income Taxes," and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. FIN 48 also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. We had no cumulative effect adjustment related to the adoption due to a full valuation allowance against deferred tax assets. We provide estimates for unrecognized tax benefits. These unrecognized tax benefits relate primarily to issues common among corporations in our industry. We apply a variety of methodologies in making these estimates which include advice from industry and subject experts, evaluation of public actions taken by the Internal Revenue Service and other taxing authorities, as well as our own industry experience. If our estimates are not representative of actual outcomes, our results could be materially impacted.

        The provision (benefit) for income taxes includes the following (in thousands):

 
  Years ended December 31,  
 
  2008   2007   2006  

Current (benefit) provision:

                   
 

Federal

  $ (657 ) $   $  
 

State

    38     38      
 

Foreign

    18     30     17  
               
   

Total current (benefit) provision

    (601 )   68     17  

Deferred (benefit) provision:

                   
 

Federal

             
 

State

    26     (1,117 )    
 

Foreign

             
               
   

Total deferred (benefit) provision

    26     (1,117 )    
   

Total (benefit) provision

 
$

(575

)

$

(1,049

)

$

17
 
               

        These amounts are included in interest and other expense in the accompanying consolidated statements of operations.

        The current Federal income tax benefit reflects the refundable research credits net of alternative minimum taxes. The Housing and Economic Recovery Act of 2008 (P.L. 110-289), enacted on July 30, 2008, provides for the acceleration of a portion of unused pre-2006 research credits and alternative minimum tax credits in lieu of claiming the 50% bonus depreciation allowance enacted in the Economic Stimulus Act of 2008. Amylin is electing to refund approximately $1.0 million of research

F-33


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

13. Income Taxes (Continued)


credit carryovers in 2008. The $1.0 million of accelerated research credits have been reflected in the current income tax benefit net of alternative minimum taxes.

        The deferred state income tax benefit in 2007 reflects the Texas margin tax (TMT) credit available to offset future margin taxes over the next 19 years. The Company estimates that its future TMT liability will be based on its gross revenues in Texas, rather than its apportioned taxable income. Therefore, it is more likely than not that the Company's TMT credit will be recovered and, accordingly, the Company has not established a valuation allowance against this asset.

        Deferred income taxes reflect the temporary differences between the carrying amounts of assets and liabilities for financial statement purposes and the amounts used for income tax purposes and the net tax effects of net operating loss and credit carryforwards. Significant components of the Company's deferred tax assets as of December 31, 2008 and 2007 are shown below (in thousands). A valuation allowance of $694.3 million has been recognized at December 31, 2008 to offset the deferred tax assets, as realization of such assets has not met the more likely than not threshold under SFAS No. 109, "Accounting for Income Taxes." Included in the gross deferred tax assets below are pre-January 1, 2006 stock option deductions that, when recognized, are estimated to increase additional paid in capital by $22.4 million.

 
  2008   2007  

Deferred tax assets:

             

Net operating loss carryforwards

  $ 409,376   $ 412,349  

Research tax credits

    61,839     58,845  

Capitalized research and development expenses

    83,564     54,253  

Accrued expenses

    58,242     36,826  

Deferred revenue

    49,192     2,919  

Stock compensation expense

    27,440     18,011  

Other, net

    5,705     3,060  
           

Total deferred tax assets

    695,358     586,263  

Valuation allowance for deferred tax assets

    (694,267 )   (585,146 )
           

Net deferred tax assets

  $ 1,091   $ 1,117  
           

The net deferred tax assets are included in other long-term assets in the accompanying consolidated balance sheets.

F-34


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

13. Income Taxes (Continued)

        Following is a summary of the Company's Federal net operating loss carryforwards, Federal research tax credit carryforwards and California net operating loss carryforwards at December 31, 2008 (in thousands):

 
  Federal net operating
loss carryforwards
  California net
operating loss
carryforwards
  Federal research
and development
tax credit
carryforwards
 

Expiring within one year

  $   $   $ 1,732  

After 1 but within 5 years

    717     25,949     3,307  

After 5 but within 10 years

    29,966     579,506     2,312  

After 10 years

    1,136,017         52,404  
               

  $ 1,166,700   $ 605,455   $ 59,755  
               

        Changes in control have occurred that triggered the limitations of Section 382 of the Internal Revenue Code on the Company's net operating loss carryforwards. The Section 382 limitations were immaterial to the Company's total net operating losses and are reflected in the net operating loss of $1.2 billion presented above.

        At December 31, 2008, the Company had Federal net operating loss carryforwards of approximately $1.2 billion, which begin to expire at the end of 2011. The Company also has California net operating loss carryforwards of $605.5 million, which begin to expire at the end of 2011, and other state net operating loss carryforwards of approximately $181.8 million, which begin to expire at the end of 2010. The difference between the Federal and California tax loss carryforwards is attributable to the capitalization of research and development expenses for California tax purposes, the prior years' limitation on California loss carryforwards and apportionment of losses to other states. The Company has Federal research tax credit carryforwards of $59.8 million, which begin to expire at the end of 2009, and California research tax credit carryforwards of $29.0 million, which carry forward indefinitely.

        The reconciliation between the Company's effective tax rate and the federal statutory rate is as follows:

 
  Tax rate for the years ended December 31,  
 
  2008   2007   2006  

Federal statutory rate applied to net loss before income tax (benefit) provision

    (35.0 )%   (35.0 )%   (35.0 )%

State taxes

    (1.6 )%       (4.0 )%

Research and development tax credits

    (0.8 )%   (3.0 )%   (3.2 )%

Stock-based compensation

    3.1 %   4.2 %   4.6 %

Increase in valuation allowance

    34.5 %   30.9 %   35.1 %

Other

    (0.4 )%   2.4 %   2.5 %
               

Effective tax rate

    (0.2 )%   (0.5 )%   %
               

        The state tax effects during 2007 include the expiration of state net operating loss carryforwards.

F-35


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

13. Income Taxes (Continued)

        As a result of the adoption of SFAS No. 123R, the Company recognizes windfall tax benefits associated with the exercise of stock options directly to stockholders' equity only when realized. Accordingly, deferred tax assets are not recognized for net operating loss carryforwards resulting from windfall tax benefits occurring from January 1, 2006 onward. A windfall tax benefit occurs when the actual tax benefit realized upon an employee's disposition of a share-based award exceeds the deferred tax asset, if any, associated with the award. At December 31, 2008, deferred tax assets do not include $44 million of excess tax benefits from stock-based compensation.

        Income taxes paid during the years ended December 31, 2008, 2007 and 2006 totaled $63 thousand, $30 thousand and $17 thousand, respectively.

        The reconciliation of the total amounts of unrecognized tax benefits at the beginning and end of the years ended December 31, 2008 and 2007 is as follows (in thousands):

 
  December 31,  
 
  2008   2007  

Reconciliation of unrecognized tax benefits:

             

Unrecognized tax benefits related to reductions in tax credits as of the beginning of the year

  $ 29,913   $ 23,645  

Decrease in unrecognized tax benefits related to reductions in tax credits as a result of tax positions taken during a prior period

    (11,711 )   339  

Increase in unrecognized tax benefits related to reductions in tax losses and credits as a result of tax positions taken during the current period

    4,239     5929  
           

Unrecognized tax benefits related to reductions in tax credits as of the end of the year

  $ 22,441   $ 29,913  
           

        The balance of unrecognized tax benefits at December 31, 2008 of $22.4 million are tax benefits that, if recognized, would not affect the Company's effective tax rate as long as they remain subject to a full valuation allowance. The net effect on the deferred tax assets and corresponding decrease in the valuation allowance at December 31, 2008 resulting from unrecognized tax benefits is $15.1 million. The Company has not recognized any accrued interest and penalties related to unrecognized tax benefits during the years ended December 31, 2008, 2007 and 2006. The Company is subject to taxation in the United States and various states and foreign jurisdictions. Effectively, all of the Company's historical tax years are subject to examination by the Internal Revenue Service and various state and foreign jurisdictions due to the generation of net operating loss and credit carryforwards. The Company does not foresee any material changes to unrecognized tax benefits within the next twelve months. The Company will elect a treatment for interest and penalties when they occur.

14. Quarterly Financial Data (Unaudited)

        The following financial information reflects all normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the results of the interim periods.

F-36


Table of Contents


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

14. Quarterly Financial Data (Unaudited) (Continued)


Summarized quarterly data for fiscal 2008 and 2007 are as follows (in thousands, except per share data):

 
  For the quarters ended  
 
  March 31   June 30   September 30   December 31  

2008:

                         

Net product sales

  $ 178,721   $ 200,335   $ 201,364   $ 184,922  

Revenues under collaborative agreements

    18,516     21,684     16,998     17,569  

Gross profit from product sales

    156,697     175,653     177,969     163,427  

Restructuring

                54,926  

Net loss

    (68,797 )   (64,816 )   (77,721 )   (104,071 )

Basic and diluted net loss per share(1)

  $ (0.51 ) $ (0.47 ) $ (0.57 ) $ (0.76 )

2007:

                         

Net product sales

  $ 162,003   $ 167,337   $ 177,391   $ 194,719  

Revenues under collaborative agreements

    9,975     29,616     12,637     27,319  

Gross profit from product sales

    146,793     152,975     163,641     172,584  

Net loss

    (49,414 )   (45,023 )   (39,758 )   (76,941 )

Basic and diluted net loss per share(1)

  $ (0.38 ) $ (0.34 ) $ (0.30 ) $ (0.57 )

(1)
Net loss per share is computed independently for each of the quarters presented. Therefore, the sum of the quarterly per-share calculations will not necessarily equal the annual per share calculation.

F-37


Table of Contents


Schedule II


AMYLIN PHARMACEUTICALS, INC

Schedule II: Valuation Accounts

(in thousands)

 
  Balance at
beginning
of period
  Additions   Deductions   Balance at
end of
period
 

Year ended December 31, 2008

                         

Inventory reserve

  $ 5,327     7,196     7,422   $ 5,101  
                   

Accounts receivable allowances(1)

  $ 12,769     34,996     32,724   $ 15,041  
                   

Year ended December 31, 2007

                         

Inventory reserve

  $ 385     7,637     2,695   $ 5,327  
                   

Accounts receivable allowances(1)

  $ 6,558     27,787     21,576   $ 12,769  
                   

Year ended December 31, 2006

                         

Inventory reserve

  $ 1,618     3,481     4,714   $ 385  
                   

Accounts receivable allowances(1)

  $ 1,628     17,203     12,273   $ 6,558  
                   

(1)
Allowances for prompt payment, product returns, doubtful accounts and wholesaler chargebacks.

F-38



EX-10.15 2 a2190933zex-10_15.htm EXHIBIT 10.15

Exhibit 10.15

 

AMYLIN PHARMACEUTICALS, INC.

AMENDED AND RESTATED

OFFICER CHANGE IN CONTROL

SEVERANCE BENEFIT PLAN

 

SECTION 1.                                                    INTRODUCTION

 

This Amylin Pharmaceuticals, Inc. Amended and Restated Officer Change in Control Severance Benefit Plan (the “Plan”) is designed to provide separation pay and benefits to Covered Employees, as such term is defined below, and hereby amends and restates through November 1, 2008 the Amylin Pharmaceuticals, Inc. Amended and Restated Officer Change in Control Severance Benefit Plan that was originally established effective February 8, 2001, and last amended and restated on August 6, 2007 (the “Prior Plan”).  This document constitutes the written instrument under which the Plan is maintained and supersedes any prior plan or practice of the Company that provides for the payment of severance benefits to Covered Employees in the form of cash and equity related benefits, including but not limited to the Prior Plan, except to the extent Covered Employees are parties to written agreements with the Company that expressly contemplate that such persons are also eligible to participate in the Plan.  .

 

SECTION 2.                                                    DEFINITIONS

 

For purposes of this Plan, the following terms shall have the meanings set forth below:

 

(a)                                  “Affiliate” means any corporation (other than the Company) in an “unbroken chain of corporations” beginning with the Company, if each of the corporations other then the last corporation in the unbroken chain owns stock possessing fifty percent (50%) or more of the total combined voting power of all classes of stock in one of the other corporations in such chain.

 

(b)                                  “Board” means the Board of Directors of the Company

 

(c)                                  “Cause” means, with respect to a Covered Employee, that, in the reasonable determination of the Company, such Covered Employee has (i) been convicted of or pleaded guilty or nolo contendere to a felony or any crime involving moral turpitude or dishonesty; (ii) participated in a fraud or act of dishonesty against the Company; (iii) willfully and materially breached a Company policy; (iv) intentionally damaged the Company’s property; (v) willfully and materially breached such Covered Employee’s Proprietary Information and Inventions Agreement with the Company; (vi) engaged in conduct that demonstrates gross unfitness to serve; or (vii) repeatedly failed to satisfactorily perform job duties to which such Covered Employee previously agreed in writing. The conduct described under clauses (iii), (vi) and (vii) above will only constitute Cause if such conduct is not cured within 90 days after the Covered Employee’s receipt of written notice from the Company or the Board specifying the particulars of the conduct that may constitute Cause.

 

(d)                                  “Change in Control” means the occurrence of any of the following:

 

(i)                                    any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities and Exchange Act of 1934, as amended from time to time, and any successor statute

 



 

(the “Exchange Act”) (other than the Company, a subsidiary, an Affiliate, or a Company employee benefit plan, including any trustee of such plan acting as trustee) is or becomes the “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of securities of the Company representing 50% or more of the combined voting power of the Company’s then outstanding securities other than by virtue of a merger, consolidation or similar transaction;

 

(ii)                                there is consummated a sale or other disposition of all or substantially all of the assets of the Company (other than a sale to an entity where at least 50% of the combined voting power of the voting securities of such entity are owned by the stockholders of the Company in substantially the same proportions as their ownership of the Company immediately prior to such sale);

 

(iii)                            there is consummated a merger, consolidation or similar transaction involving (directly or indirectly) the Company and, immediately after the consummation of such transaction, the stockholders immediately prior to the consummation of such transaction do not own, directly or indirectly, outstanding voting securities representing more than 50% of the combined outstanding voting power of the surviving entity in such transaction or more than 50% of the combined outstanding voting power of the parent of the surviving entity in such transaction.

 

(e)                                  “Company” means Amylin Pharmaceuticals, Inc., a Delaware corporation and its Affiliates, or following a Change in Control, the surviving entity resulting from such transaction.

 

(f)                                    “Compensation Committee” means the Compensation Committee of the Board.

 

(g)                                 “Constructive Termination” means, with respect to a Covered Employee, that such Covered Employee voluntarily terminates his or her employment with the Company (A) after (1) any of the following are undertaken without Cause and without such Covered Employee’s express written consent; (2) the Covered Employee notifies the Company in writing, within ninety (90) days after the occurrence of one of the following events, which notice specifies the condition giving rise to a Constructive Termination and that the Covered Employee intends to terminate his employment no earlier than thirty (30) days after the Company’s receipt of such notice; and (3) the Company does not cure such condition within thirty (30) days following its receipt of such notice or states unequivocally in writing that it does not intend to attempt to cure such condition; and (B) such voluntary termination occurs within thirty (30) days following the end of the period within which the Company was entitled to remedy the condition giving rise to a Constructive Termination but failed to do so:

 

(i)                                    a material reduction by the Company of such Covered Employee’s annual base salary as in effect during the last regularly scheduled payroll period immediately prior to the period commencing 90 days prior to the applicable Change in Control (or as increased thereafter), unless such reduction is made pursuant to an across-the-board reduction of the base salaries of all similarly situated Covered Employee’s of no more than ten percent (10%);

 

(ii)                                such Covered Employee’s relocation, or the relocation of the Company’s principal executive offices if such Covered Employee’s principal office is at such offices by

 

2



 

more than fifty (50) miles from the location at which such Covered Employee was performing his or her duties immediately prior to the 90 day period preceding the applicable Change in Control, except for required travel on the Company’s business to an extent substantially consistent with such Covered Employee’s business travel obligations immediately prior to the commencement of such period;

 

(iii)                            such Covered Employee’s assignment during the period beginning ninety (90) days prior to and ending thirteen (13) months after the applicable Change in Control of any duties or responsibilities that results in a material diminution in such Covered Employee’s authority, duties or responsibilities from those in effect immediately prior to the commencement of such period; provided, however, that with respect only to those Covered Employees serving as the Chief Executive Officer and/or Chief Financial Officer of the Company immediately prior to the commencement of such period (each a “Key Executive”), if (i) in the case of the Key Executive so serving as Chief Executive Officer (the “CEO”), such Key Executive shall no longer report during such period directly to the Board of Directors of the Company or, following such Change in Control, shall not report directly to the board of directors of the publicly traded entity that is, or is part of the controlled group that includes, the successor or acquiring party in such Change in Control or (ii) in the case of the Key Executive so serving as Chief Financial Officer, there shall be a material diminution in the authority, duties or responsibilities of the supervisor to whom such Key Executive is required to report (including without limitation by reason of such Key Executive continuing to report to the CEO during such period but the CEO at any time during such period no longer reporting directly to the Board of Directors of the Company or, following such Change in Control, not reporting directly to the board of directors of the publicly traded entity that is, or is part of the controlled group that includes, the successor or acquiring party in such Change in Control) and/or a requirement that either such Key Executive or his or her supervisor shall report to a corporate officer or employee instead of reporting directly to the CEO), then, without limitation, in each case such Key Executive shall be considered to have suffered a material diminution in such Key Executive’s authority, duties or responsibilities; or

 

(iv)                               a material breach by the Company of any provision of this Plan or any enforceable written agreement between such Covered Employee and the Company.

 

(h)                                 “Covered Employee” means a person eligible to participate in the Plan as provided in Section 3 herein.

 

(i)                                    “Covered Termination” means either a Constructive Termination or an Involuntary Termination Without Cause.

 

(j)                                    “Disability” means the Covered Employee is prevented from performing his duties hereunder by reason of any physical or mental incapacity that results in the Covered Employee’s satisfaction of all requirements necessary to receive benefits under the Company’s long-term disability plan due to a total disability.

 

(k)                                “Executive Officer” means an officer who has been designated by the Company as an executive officer who is subject to Section 16 of the Securities Exchange Act of 1934.

 

3



 

(l)                                    “Involuntary Termination Without Cause” means with respect to a Covered Employee such Covered Employee’s dismissal or discharge by the Company for a reason other than for Cause.  The termination of a Covered Employee’s employment will not be deemed to be an “Involuntary Termination Without Cause” if such Covered Employee’s termination occurs as a result of such Covered Employee’s death or Disability.

 

(m)                              “Payment Commencement Date” means, with respect to a Covered Termination, (i) if such Covered Termination occurs prior to the effective date of the applicable Change in Control, the later of (A) the effective date of such Change in Control or (B) the effective date of the Release required by Section 4(e) or (ii) if such Covered Termination occurs on or after the effective date of the applicable Change in Control, the later of (X) the date of such Covered Termination or (Y) the effective date of the Release required by Section 4(e).

 

(n)                                 Plan Administrator” has the meaning as provided in Section 7.

 

(o)                                  Qualified Plan” means a plan sponsored by the Company or an Affiliate that is intended to be qualified under Section 401(a) of the Internal Revenue Code.

 

(p)                                  “Substantial Risk of Forfeiture Lapse Date” means, with respect to a Covered Termination, (i) if such Covered Termination occurs prior to the effective date of the applicable Change in Control, the effective date of such Change in Control, or (ii) if such Covered Termination occurs on or after the effective date of the applicable Change in Control, the date of such Covered Termination.

 

SECTION 3.                                                    ELIGIBILITY AND PARTICIPATION

 

A person is eligible to participate in the Plan if (i) such person is an employee of the Company or an Affiliate with the title of Vice-President or higher; (ii) such person has not entered into a separate individual “severance benefit” or “change in control agreement” with the Company (excluding any plan or arrangement, or any portion thereof, relating to equity compensation) except to the extent such person is a party to a written agreement with the Company that expressly contemplates that such person is also eligible to participate in the Plan; (iii) the Board has designated such person as eligible to participate in the Plan; and (iv) such person’s employment with the Company terminates due to either (A) an Involuntary Termination at any time during the period beginning ninety (90) days prior to and ending thirteen (13) months following the effective date of a Change in Control, or (B) a Constructive Termination for which the condition set forth in Section 2(g)(i)-(iv), as applicable, giving rise to the right to resign due to a Constructive Termination occurred at any time during the period beginning ninety (90) days prior to and ending thirteen (13) months following the effective date of a Change in Control.  The determination of whether an employee is a Covered Employee shall be made by the Company, in its sole discretion, and such determination shall be binding and conclusive on all persons.

 

SECTION 4.                                                    BENEFITS

 

Plan benefits will not affect a Covered Employee’s rights to payment of any other compensation from the Company that has been earned by the Covered Employee but has not yet been paid at the time of the Covered Termination.  Provided that all conditions for receiving benefits under

 

4



 

the Plan are met, each Covered Employee is eligible to receive the following benefits:

 

(a)                                  Salary Continuation Payments.  The Company shall continue to pay the Base Salary of each Covered Employee, as in effect on the date of the applicable Covered Termination, for the number of months following the Payment Commencement Date set forth in the following table based on the most senior employment title of such Covered Employee in effect at the time of such Covered Termination:

 

Title

 

Base Salary
Continuation Period

 

Chief Executive Officer or President

 

36 months

 

Executive Officer

 

24 months

 

Vice President other than Executive Officer

 

18 months

 

 

Such amounts shall be paid to each such Covered Employee in regular installments on the normal payroll dates of the Company commencing with the first payroll period following the Payment Commencement Date.  Any salary continuation payments that any Covered Employee receives hereunder shall be subject to all required tax withholding.

 

Base Salary” shall mean the Covered Employee’s base pay (excluding incentive pay, premium pay, commissions, overtime, bonuses and other forms of variable compensation), at the rate in effect during the last regularly scheduled payroll period immediately preceding the date of the Covered Termination, and prior to any reduction in base salary that would permit such Covered Employee to voluntarily terminate employment in a Constructive Termination pursuant to Section 2(g)(i).

 

(b)                                  Bonus Payment.  The Company shall pay to each Covered Employee a percentage of such Covered Employee’s Maximum Potential Bonus (defined below) as set forth in the following table based on the most senior employment title of such Covered Employee in effect at the time of the applicable Covered Termination:

 

5



 

Title

 

Percentage of
Maximum Bonus Potential

 

Chief Executive Officer or President

 

300

%

Executive Officer

 

200

%

Vice President other than Executive Officer

 

100

%

 

“Maximum Potential Bonus” means:

 

(i) if, on or prior to the date of the Covered Termination, the Compensation Committee shall have approved an Executive Cash Bonus Plan or similar plan applicable to such Covered Employee and related Company and/or Covered Employee individual performance goals thereunder (collectively, “Cash Bonus Plan”) applicable for the year in which such Covered Termination occurs, the maximum full year cash bonus payable to such Covered Employee under such Cash Bonus Plan as if 100% of all such performance goals were attained for such year;

 

(ii) if, on or prior to the date of the Covered Termination, the Compensation Committee shall not have approved a Cash Bonus Plan applicable to such Covered Employee for the year in which such Covered Termination occurs, but a Cash Bonus Plan applicable to such Covered Employee exists for the year immediately preceding the year in which such Covered Termination occurs, the maximum full year cash bonus payable to such Covered Employee under the Cash Bonus Plan in effect for such immediately preceding year as if 100% of all applicable performance goals were attained; or

 

(iii) if, on or prior to the date of the Covered Termination, the Compensation Committee shall not have approved a Cash Bonus Plan applicable to such Covered Employee for either the year in which such Covered Termination occurs or the immediately preceding year, the largest maximum full year cash bonus payable to any other Company officer with an employment title equivalent to or below the employment title of such Covered Employee as of the date of the Covered Termination, under either a Cash Bonus Plan in effect for the year of such Covered Termination or the immediately preceding the year as if 100% of all applicable performance goals were attained.

 

Any such bonus payment pursuant to this Section 4(b) shall be in a single lump sum to be paid within ten (10) days following the Payment Commencement Date.  Any bonus payments that any Covered Employee receives shall be subject to all required tax withholding.

 

(c)                                  COBRA Premium Benefits.  If a Covered Employee is eligible to elect continued group health plan coverage under Consolidated Omnibus Budget Reconciliation Act of 1985 (“COBRA”) following a Covered Termination, regardless of whether the Covered Employee makes an election for continued COBRA coverage, the Company shall pay a single

 

6



 

lump sum payment equal to 140% of the full amount of the Covered Employee’s COBRA premiums for the Covered Employee’s continued coverage under the Company’s group health plans, including the cost of coverage for the Covered Employee’s eligible dependents, for a period of eighteen (18) months.  For purposes of this Section 4(c), references to COBRA premiums shall not include any amounts payable by the Covered Employee under an Internal Revenue Code Section 125 health care reimbursement plan.  Any such payment that such Covered Employee receives shall be subject to all required tax withholding and shall be paid in a single lump sum within ten (10) days following the Payment Commencement Date.

 

(d)                                  Equity Award Vesting Acceleration Benefits.  Effective as of the date of the Covered Employee’s Covered Termination: (i) the vesting and exercisability of all outstanding options to purchase the Company’s common stock that are held by the Covered Employee on such date shall be accelerated in full as of the date of such Covered Termination, (ii) any reacquisition or repurchase rights held by the Company in respect of common stock issued pursuant to any other stock award granted to the Covered Employee by the Company shall lapse in full as of the date of such Covered Termination, and (iii) the vesting of any other stock awards granted to the Covered Employee by the Company, and any issuance of shares triggered by the vesting of such stock awards, shall be accelerated in full as of the date of such Covered  Termination.   If the Covered Termination occurs prior to the effective date of the applicable Change in Control, such vesting acceleration shall be deemed effective as of the date of the Covered Termination.  Notwithstanding the foregoing, this Section 4(d) shall not apply to stock awards issued under or held in any Qualified Plan.

 

(e)                                  Conditions to Receipt of Benefits.   In order to be eligible to receive any benefits under the Plan, a Covered Employee also must satisfy each of the following conditions:

 

(i)                                    The Covered Employee or his or her representative must execute a general waiver and release of claims in  substantially the form attached hereto as Exhibit A, Exhibit B or Exhibit C, as appropriate (the “Release”), within the time period set forth therein, but in no event later than (i) if a Change in Control shall have occurred prior to such Covered Termination, forty-five (45) days following termination of employment or (ii) if a Change in Control shall not have occurred prior to such Covered Termination, the later of (A) forty-five (45) days following termination of employment or (B) ten (10) days following the effective date of such Change in Control, and such release must become effective in accordance with its terms.  The Company, in its discretion, may modify the form of the required Release at any time to comply with applicable law and shall determine the form of the required Release, which may be incorporated into a termination agreement or other agreement with the Covered Employee.

 

(ii)                                Following any notification of Involuntary Termination Without Cause by the Company, the Covered Employee must reasonably satisfactorily perform his or her assigned job duties until the date set by the Company for the termination of employment, which date may not exceed thirty (30) days following such notification.

 

(f)                                    Termination of Benefits.  With respect to each Covered Employee, benefits under this Plan shall terminate immediately if such Covered Employee, at any time, violates any provision of the Proprietary Information and Inventions Agreement or any other proprietary information, confidentiality or non-solicitation obligation to the Company.

 

7


 

(g)                                 Non-Duplication of Benefits.  No Covered Employee is eligible to receive benefits under this Plan more than one time.

 

(h)                                 Offset for Indebtedness.  If a Covered Employee is indebted to the Company at his or her termination date, the Company reserves the right to offset any salary continuation severance payments or other payments under the Plan by the amount of such indebtedness.  Additionally, if a Covered Employee is subject to withholding for taxes related to any non-Plan benefits, the Company may offset any salary continuation severance payments or other payments under the Plan by the amount of such withholding taxes.

 

(i)                                    Certain Reductions.  The Company, in its sole discretion, shall have the authority to reduce a Covered Employee’s benefits under this Plan, in whole or in part, by any other severance benefits, pay in lieu of notice, or other similar benefits payable to the Covered Employee by the Company or an Affiliate of the Company that become payable in connection with the Covered Employee’s termination of employment pursuant to any applicable legal requirement, including, without limitation, the Worker Adjustment and Retraining Notification Act, the California Plant Closing Act, or any other similar state law, and the Plan Administrator shall so construe and implement the terms of the Plan; provided, however, that notwithstanding the foregoing and any other provision in the Plan to the contrary, such reductions shall in no event reduce the cash severance benefits provided under this Plan to less than two (2) weeks of Base Salary (as such term is defined above).  The Company’s decision to apply such reductions to any particular Covered Employee and the amount of such reductions shall in no way obligate the Company to apply the same reductions in the same amounts to any other Covered Employee, even if similarly situated.  In the Company’s sole discretion, such reductions may be applied on a retroactive basis, with salary continuation severance payments or other severance benefits previously paid being re-characterized as payments pursuant to the Company’s statutory obligation.

 

(j)                                    Deferred Compensation.  Notwithstanding anything to the contrary set forth herein, any payments and benefits provided under this Plan (the “Severance Benefits”) that constitute “deferred compensation” within the meaning of Section 409A of the Code and the regulations and other guidance thereunder and any state law of similar effect (collectively “Section 409A”) shall not commence in connection with a Covered Employee’s termination of employment unless and until the Covered Employee has also incurred a “separation from service” (as such term is defined in Treasury Regulation Section 1.409A-1(h) (“Separation From Service”), unless the Company reasonably determines that such amounts may be provided to the Covered Employee without causing the Covered Employee to incur the additional 20% tax under Section 409A.  Severance Benefits payable under the Plan on or before March 15 of the calendar year following the calendar year including the Substantial Risk of Forfeiture Lapse Date are intended to constitute separate payments for purposes of Section 1.409A-2(b)(2) of the Treasury Regulations and thus will be payable pursuant to the “short-term deferral” rule set forth in Section 1.409A-1(b)(4) of the Treasury Regulations.  Severance Benefits payable under the Plan after March 15 of the calendar year following the calendar year including the Substantial Risk of Forfeiture Lapse Date are intended to constitute separate payments for purposes of Section 1.409A-2(b)(2) of the Treasury Regulations made upon an involuntary termination from service and payable pursuant to Section 1.409A-1(b)(9)(iii) of the Treasury Regulations, to the maximum extent permitted by said provision, with any excess amount being regarded as subject

 

8



 

to the distribution requirements of Section 409A(a)(2)(A) of the Internal Revenue Code of 1986, as amended (the “Code”), including, without limitation, the requirement of Section 409A(a)(2)(B)(i) of the Code that payment to the Covered Employee be delayed until 6 months after separation from service if the Covered Employee is a “specified employee” within the meaning of the aforesaid section of the Code at the time of such separation from service.

 

SECTION 5.                                                    PARACHUTE PAYMENTS

 

In the event that the payments provided herein and benefits otherwise payable to a Covered Employee (i) constitute “parachute payments” within the meaning of Section 280G of the Code, or any comparable successor provisions, and (ii) but for this Section 5 would be subject to the excise tax imposed by Section 4999 of the Code, or any comparable successor provisions (the “Excise Tax”), then such Covered Employee’s benefits hereunder shall be either:

 

(i)                                    provided to such Covered Employee in full, or

 

(ii)                                provided to such Covered Employee as to such lesser extent which would result in no portion of such benefits being subject to the Excise Tax,

 

whichever of the foregoing amounts, when taking into account applicable federal, state, local and foreign income and employment taxes, the Excise Tax, and any other applicable taxes, results in the receipt by such Covered Employee, on an after-tax basis, of the greatest amount of benefits, notwithstanding that all or some portion of such benefits may be taxable under the Excise Tax (the “Reduced Amount”).  If a reduction in payments or benefits constituting “parachute payments” is necessary so that the Payment equals the Reduced Amount, reduction shall occur in the following order:  reduction of cash payments; cancellation of accelerated vesting of stock awards; reduction of employee benefits.  If acceleration of vesting of stock award compensation is to be reduced, such acceleration of vesting shall be cancelled in the reverse order of the date of grant of the Covered Employee’s stock awards.

 

Unless the Company and such Covered Employee otherwise agree in writing, any determination required under this Section 5 shall be made in writing in good faith by the Company’s independent certified public accountants (the “Accountants”).  For purposes of making the calculations required by this Section 5, the Accountants may make reasonable assumptions and approximations concerning applicable taxes and may rely on reasonable, good faith interpretations concerning the application of the Code, and other applicable legal authority.  The Company and such Covered Employee shall furnish to the Accountants such information and documents as the Accountants may reasonably request in order to make a determination under this Section 5.  The Company shall bear all costs the Accountants may reasonably incur in connection with any calculations contemplated by this Section 5.

 

If, notwithstanding any reduction described in this Section 5, the IRS determines that such Covered Employee is liable for the Excise Tax as a result of the receipt of the payment of benefits as described above, then such Covered Employee shall be obligated to pay back to the Company, within thirty (30) days after a final IRS determination or in the event that such Covered Employee challenges the final IRS determination, a final judicial determination, a

 

9



 

portion of the payment equal to the “Repayment Amount.”  The Repayment Amount with respect to the payment of benefits shall be the smallest such amount, if any, as shall be required to be paid to the Company so that such Covered Employee’s net after-tax proceeds with respect to any payment of benefits (after taking into account the payment of the Excise Tax and all other applicable taxes imposed on such payment) shall be maximized.  The Repayment Amount with respect to the payment of benefits shall be zero if a Repayment Amount of more than zero would not result in such Covered Employee’s net after-tax proceeds with respect to the payment of such benefits being maximized.  If the Excise Tax is not eliminated pursuant to this paragraph, such Covered Employee shall pay the Excise Tax.

 

Notwithstanding any other provision of this Section 5, if (i) there is a reduction in the payment of benefits as described in this Section 5, (ii) the IRS later determines that such Covered Employee is liable for the Excise Tax, the payment of which would result in the maximization of such Covered Employee’s net after-tax proceeds (calculated as if such Covered Employee’s benefits had not previously been reduced), and (iii) such Covered Employee pays the Excise Tax, then the Company shall pay to such Covered Employee those benefits which were reduced pursuant to this Section 5 contemporaneously or as soon as administratively possible after such Covered Employee pays the Excise Tax so that such Covered Employee’s net after-tax proceeds with respect to the payment of benefits is maximized.

 

If a Covered Employee either (i) brings any action to enforce such Covered Employee’s rights pursuant to this Section 5, or (ii) defends any legal challenge to such Covered Employee’s rights hereunder, such Covered Employee shall be entitled to recover attorneys’ fees and costs incurred in connection with such action, regardless of the outcome of such action; provided, however, that in the event such action is commenced by such Covered Employee, the court finds the claim was brought in good faith.

 

SECTION 6.                                                    COMPANY PROPERTY.

 

A Covered Employee will not be entitled to any benefit under the Plan unless and until the Covered Employee returns all Company Property, except to the extent such obligation is waived in writing by the Company.  For this purpose, “Company Property” means all Company and/or Affiliate documents (and all copies thereof) and other Company and/or Affiliate property which the Covered Employee had in his or her possession at any time, including, but not limited to, Company and/or Affiliate files, notes, drawings records, plans, forecasts, reports, studies, analyses, proposals, agreements, financial information, research and development information, sales and marketing information, operational and personnel information, specifications, code, software, databases, computer-recorded information, tangible property and equipment (including, but not limited to, leased vehicles, computers, facsimile machines, mobile telephones, servers), credit cards, entry cards, identification badges and keys; and any materials of any kind which contain or embody any proprietary or confidential information of the Company and/or an Affiliate (and all reproductions thereof in whole or in part).  As a condition to receiving benefits under the Plan, Covered Employees must not make or retain copies, reproductions or summaries of any such Company or Affiliate property.

 

10



 

SECTION 7.                                                    ADMINISTRATION AND OPERATION OF THE PLAN

 

The Company is the “Plan Sponsor” and the “Plan Administrator” of the Plan, as such terms are defined in the Employee Retirement Income Security Act of 1974 (“ERISA”).  The Company, in its capacity as Plan Administrator of the Plan, is the named fiduciary that has the authority to control and manage the operation and administration of the Plan.  The Company has the sole discretion to make such rules, regulations, interpretations of the Plan and computations and shall take such other action to administer the Plan as it may deem appropriate in its sole discretion.  Such rules, regulations, interpretations, computations, and other actions shall be conclusive and binding upon all persons.  The Company may engage the services of such persons or organizations to render advice or perform services with respect to its responsibilities under the Plan as it shall determine to be necessary or appropriate.  Such persons or organizations may include (without limitation) actuaries, attorneys, accountants and consultants.

 

Any person or group of persons may serve in more than one fiduciary capacity with respect to the Plan.  The responsibilities of the Company under the Plan shall be carried out on its behalf by its directors, officers, employees and agents, acting on behalf or in the name of the Company in their capacity as directors, officers, employees and agents and not as individual fiduciaries.  The Company may delegate any of its fiduciary responsibilities under the Plan to another person or persons pursuant to a written instrument that specifies the fiduciary responsibilities so delegated to each such person.

 

The Company may also delegate the administration of some or all of the provisions of the Plan to a committee or committees consisting of one or more persons appointed by the Company (“Committee”).  If administration of the Plan is delegated to a Committee, the Committee shall have, in connection with the administration of the Plan, the powers theretofore possessed by the Company that have been delegated to the Committee, including the power to delegate to a subcommittee of the Committee any of the administrative powers the Committee is authorized to exercise (and references in this Plan to the Company shall thereafter be to the Committee or subcommittee), subject, however, to such resolutions, not inconsistent with the provisions of the Plan, as may be adopted from time to time by the Company.

 

SECTION 8.                                                    CLAIMS, INQUIRIES AND APPEALS

 

(a)                                  Applications for Benefits and Inquiries.  Any application for benefits, inquiries about the Plan or inquiries about present or future rights under the Plan must be submitted to the Plan Administrator in writing by an applicant (or his or her authorized representative) to:

 

Attention: Corporate Secretary

Re: Officer Change in Control Severance Benefit Plan

Amylin Pharmaceuticals, Inc.

9360 Towne Centre Drive

San Diego, California 92121

 

(b)                                  Denial of Claims.  In the event that any application for benefits is denied in whole or in part, the Plan Administrator must provide the applicant with written or electronic notice of the denial of the application, and of the applicant’s right to review the denial.  Any

 

11



 

electronic notice will comply with the regulations of the U.S. Department of Labor.  The written notice of denial will be set forth in a manner designed to be understood by the employee and will include the following:

 

(i)                                    the specific reason or reasons for the denial;

 

(ii)                                references to the specific Plan provisions upon which the denial is based;

 

(iii)                            a description of any additional information or material that the Plan Administrator needs to complete the review and an explanation of why such information or material is necessary; and

 

(iv)                               an explanation of the Plan’s review procedures and the time limits applicable to such procedures, including a statement of the applicant’s right to bring a civil action under section 502(a) of ERISA following a denial on review of the claim, as described in Section 8(d) below.

 

This written notice will be given to the applicant within ninety (90) days after the Plan Administrator receives the application, unless special circumstances require an extension of time, in which case, the Plan Administrator has up to an additional ninety (90) days for processing the application.  If an extension of time for processing is required, written notice of the extension will be furnished to the applicant before the end of the initial ninety (90) day period.

 

This notice of extension will describe the special circumstances necessitating the additional time and the date by which the Plan Administrator is to render its decision on the application.

 

(c)                                  Request for a Review.  Any person (or that person’s authorized representative) for whom an application for benefits is denied, in whole or in part, may appeal the denial by submitting a request for a review to the Plan’s Review Panel within sixty (60) days after the application is denied.  The Review Panel shall be comprised of two (2) or more persons to be appointed by the Company.  A request for a review shall be in writing and shall be addressed to:

 

Attention: Corporate Secretary

Re: Officer Change in Control Severance Benefit Plan

Amylin Pharmaceuticals, Inc.

9360 Towne Centre Drive

San Diego, California 92121

 

A request for review must set forth all of the grounds on which it is based, all facts in support of the request and any other matters that the applicant feels are pertinent.  The applicant (or his or her representative) shall have the opportunity to submit (or the Review Panel) may require the applicant to submit) written comments, documents, records, and other information relating to his or her claim.  The applicant (or his or her representative) shall be provided, upon request and free of charge, reasonable access to, and copies of, all documents, records and other information relevant to his or her claim.  The review shall take into account all comments, documents, records and other information submitted by the applicant (or his or her

 

12



 

representative) relating to the claim, without regard to whether such information was submitted or considered in the initial benefit determination.

 

(d)                                  Decision on Review.  The Review Panel will act on each request for review within sixty (60) days after receipt of the request, unless special circumstances require an extension of time (not to exceed an additional sixty (60) days), for processing the request for a review.  If an extension for review is required, written notice of the extension will be furnished to the applicant within the initial sixty (60) day period.  This notice of extension will describe the special circumstances necessitating the additional time and the date by which the Plan Administrator is to render its decision on the review.  The Review Panel will give prompt, written or electronic notice of its decision to the applicant. Any electronic notice will comply with the regulations of the U.S. Department of Labor.  In the event that the Review Panel confirms the denial of the application for benefits in whole or in part, the notice will set forth, in a manner calculated to be understood by the applicant, the following:

 

(i)                                    the specific reason or reasons for the denial;

 

(ii)                                references to the specific Plan provisions upon which the denial is based;

 

(iii)                            a statement that the applicant is entitled to receive, upon request and free of charge, reasonable access to, and copies of, all documents, records and other information relevant to his or her claim; and

 

(iv)                               a statement of the applicant’s right to bring a civil action under section 502(a) of ERISA.

 

(e)                                  Rules and Procedures.  The Plan Administrator and/or the Review Panel may establish rules and procedures, consistent with the Plan and with ERISA, as necessary and appropriate in carrying out its responsibilities in reviewing benefit claims.  The Review Panel may require an applicant who wishes to submit additional information in connection with an appeal from the denial of benefits to do so at the applicant’s own expense.

 

(f)                                    Exhaustion of Remedies.  No legal action for benefits under the Plan may be brought until the claimant (i) has submitted a written application for benefits in accordance with the procedures described by Section 8(a) above, (ii) has been notified by the Plan Administrator that the application is denied, (iii) has filed a written request for a review of the application in accordance with the appeal procedure described in Section 8(c) above, and (iv) has been notified in writing that the Plan Administrator has denied the appeal.  Notwithstanding the foregoing, if the Plan Administrator and/or Review Panel, as the case may be, does not respond to a Participant’s claim or appeal within the relevant time limits specified in this Section 8, the Participant may bring legal action for benefits under the Plan pursuant to Section 502(a) of ERISA.

 

SECTION 9.                                                    OTHER TERMINATIONS

 

A Covered Employee is not eligible for benefits under this Plan if (i) such Covered Employee is terminated within thirty (30) days following such Covered Employee’s refusal to accept an offer of comparable employment by any successor to the Company or an Affiliate

 

13



 

thereof (provided that “comparable employment” shall mean employment with base salary in an amount not violative of Section 2(g)(i) and at a business office whose location is not violative of Section 2(g)(ii)); (ii) such Covered Employee is terminated following such Covered Employee’s refusal to allow any successor to or Affiliate of the Company access to such Covered Employee’s employment records or access to Company personnel regarding such Covered Employee’s performance for the purpose of evaluating such Covered Employee’s qualifications for future employment, (iii) the Covered Employee terminates employment in order to accept employment with another entity that is wholly or partly owned (directly or indirectly) by the Company or an Affiliate, (iv) the Covered Employee does not satisfy each of the conditions for receipt of benefits as set forth in Section 4(e) of this Plan, or (v) such Covered Employee’s employment terminates due to death, Disability or any other reason other than (A) an Involuntary Termination occurring at any time during the period beginning ninety (90) days prior to and ending thirteen (13) months following the effective date of a Change in Control, or (B) a Constructive Termination for which the condition set forth in Section 2(g)(i)-(iv), as applicable, giving rise to the right to resign due to a Constructive Termination occurred at any time during the period beginning ninety (90) days prior to and ending thirteen (13) months following the effective date of a Change in Control.

 

SECTION 10.                                             BASIS OF PAYMENTS TO AND FROM THE PLAN

 

All benefits under the Plan shall be paid by the Company.  The Plan shall be unfunded and benefits hereunder shall be paid only from the general assets of the Company.  A Covered Employee’s right to receive payments under the Plan is no greater than that of the Company’s unsecured general creditors.  Therefore, if the Company were to become insolvent, the Covered Employee might not receive benefits under the Plan.

 

SECTION 11.                                             AMENDMENT AND TERMINATION

 

The current term of the Plan shall continue through December 31, 2009.  This Plan shall thereafter remain in effect for successive two-year periods beginning January 1, 2010 unless and until the Board elects that the then-current two-year period shall be the final effective period for this Plan by a duly adopted resolution effected at least 90 days prior to the expiration of that two-year period.  Subject to the foregoing provision, the Company reserves the right to amend or terminate this Plan at any time; provided, however, that the Plan may not be amended or terminated within 90 days prior to or at any time following the occurrence of a Change in Control.

 

SECTION 12.                                             NON-ALIENATION OF BENEFITS

 

No Plan benefit may be anticipated, alienated, sold, transferred, assigned, pledged, encumbered or charged, and any attempt to do so will be void.

 

SECTION 13.                                             SUCCESSORS AND ASSIGNS

 

(i)                                    This Plan shall be binding upon any surviving entity resulting from a Change in Control and upon any other person who is a successor by merger, acquisition, consolidation or otherwise to the business formerly carried on by the Company without regard to whether or not such person actively adopts or formally continues the Plan.  Covered Employees,

 

14


 

 

to the extent they are otherwise eligible for benefits under the Plan, are intended third party beneficiaries of this provision. The Company shall require the assumption of this Plan by any successor or assign of the Company

 

SECTION 14.                                             LEGAL CONSTRUCTION

 

This Plan shall be interpreted in accordance with ERISA and, to the extent not preempted by ERISA, with the laws of the State of California.  This Plan constitutes both a plan document and a summary plan description for purposes of ERISA.

 

SECTION 15.                                             OTHER PLAN INFORMATION

 

(a)           Employer Identification Number:   33-026609

 

(b)           Ending of the Plan’s Fiscal Year:  December 31.

 

(c)           Agent for the Service of Legal Process:  The Plan’s agent for service of legal process is:  General Counsel, Amylin Pharmaceuticals, Inc., 9360 Towne Centre Drive, San Diego, CA 92121.

 

(d)           Type of Plan:  The Plan is a welfare benefit plan.

 

(e)           Plan Number:  The Plan Number assigned to the Plan by the Plan Sponsor pursuant to the instructions of the Internal Revenue Service is 511.

 

(f)            Address for Plan Sponsor and Plan Administrator.  The contact information for the Plan Sponsor and the Plan Administrator of the Plan is:

 

Amylin Pharmaceuticals, Inc.

Attention: Corporate Secretary

9360 Towne Centre Drive

San Diego, California 92121

 

SECTION 16.                                             STATEMENT OF ERISA RIGHTS

 

The terms “you” and “your” shall apply to each Covered Employee, as applicable.  As a participant in this Plan (which is a welfare benefit plan sponsored by the Company) you are entitled to certain rights and protections under ERISA, including the right to:

 

(a)           Examine, without charge, at the Plan Administrator’s office and at other specified locations, such as work sites, all Plan documents and copies of all documents filed by the Plan with the U.S. Department of Labor, such as detailed annual reports;

 

(b)           Obtain copies of all Plan documents and Plan information upon written request to the Plan Administrator.  The Plan Administrator may make a reasonable charge for the copies; and

 

15



 

(c)           Receive a summary of the Plan’s annual financial report, in the case of a plan which is required to file an annual financial report with the Department of Labor.

 

In addition to creating rights for Plan participants, ERISA imposes duties upon the people responsible for the operation of the employee benefit plan.  The people who operate the Plan, called “fiduciaries” of the Plan, have a duty to do so prudently and in the interest of you and other Plan participants and beneficiaries.

 

No one, including your employer or any other person, may fire you or otherwise discriminate against you in any way to prevent you from obtaining a Plan benefit or exercising your rights under ERISA.  If your claim for a Plan benefit is denied in whole or in part, you must receive a written explanation of the reason for the denial.  You have the right to have the Plan Administrator review and reconsider your claim.

 

Under ERISA, there are steps you can take to enforce the above rights.  For instance, if you request materials from the Plan Administrator and do not receive them within 30 days, you may file suit in a federal court.  In such a case, the court may require the Plan Administrator to provide the materials and pay you up to $100 a day until you receive the materials, unless the materials were not sent because of reasons beyond the control of the Plan Administrator.  If you have a claim for benefits that is denied or ignored, in whole or in part, you may file suit in a state or federal court.  If it should happen that the Plan fiduciaries misused the Plan’s money, or if you are discriminated against for asserting your rights, you may seek assistance from the U.S. Department of Labor, or you may file suit in a federal court.  The court will decide who should pay court costs and legal fees.  If you are successful, the court may order the person you have sued to pay these costs and fees.  If you lose, the court may order you to pay these costs and fees, for example, if it finds your claim is frivolous.

 

If you have any questions about the Plan, you should contact the Plan Administrator.  If you have any questions about this statement or about your rights under ERISA, or if you need assistance in obtaining documents from the Plan Administrator, you should contact the nearest office of the Employee Benefits Security Administration, U.S. Department of Labor, listed in your telephone directory or the Division of Technical Assistance and Inquiries, Employee Benefits Security Administration, U.S. Department of Labor, 200 Constitution Avenue N.W., Washington, D.C. 20210.  You may also obtain certain publications about your rights and responsibilities under ERISA by calling the publications hotline of the Employee Benefits Security Administration or accessing its website at http://www.dol.gov/ebsa/.

 

Exhibit A:  Release (Employees Age 40 and Older Individual Termination)

Exhibit B:  Release (Employees Age 40 and Older Group Termination)

Exhibit C:  Release (Employees Under Age 40 Individual and Group Termination)

 

16



 

For Employees Age 40 and Older

Individual Termination

 

EXHIBIT A

 

RELEASE

 

Certain capitalized terms used in this Release are defined in the Amylin Pharmaceuticals, Inc. Officer Change in Control Severance Benefit Plan (the “Plan”) which I have reviewed.

 

I hereby confirm my obligations under the Company’s proprietary information and inventions agreement.

 

I understand that this Release, together with the Plan, constitutes the complete, final and exclusive embodiment of the entire agreement between the Company, affiliates of the Company and me with regard to the subject matter hereof.  I am not relying on any promise or representation by the Company that is not expressly stated therein.

 

I acknowledge that I have read and understand Section 1542 of the California Civil Code which reads as follows: “A general release does not extend to claims which the creditor does not know or suspect to exist in his favor at the time of executing the release, which if known by him must have materially affected his settlement with the debtor.”  I hereby expressly waive and relinquish all rights and benefits under that section and any law of any jurisdiction of similar effect with respect to my release of any claims I may have against the Company.

 

Except as otherwise set forth in this Release, I hereby release, acquit and forever discharge the Company, its parents and subsidiaries, and their officers, directors, agents, servants, employees, shareholders, successors, assigns and affiliates, of and from any and all claims, liabilities, demands, causes of action, costs, expenses, attorneys fees, damages, indemnities and obligations of every kind and nature, in law, equity, or otherwise, known and unknown, suspected and unsuspected, disclosed and undisclosed (other than any claim for indemnification I may have as a result of any third party action against me based on my employment with the Company), arising out of or in any way related to agreements, events, acts or conduct at any time prior to the date I execute this Release, including, but not limited to:  all such claims and demands directly or indirectly arising out of or in any way connected with my employment with the Company or the termination of that employment, including but not limited to, claims of intentional and negligent infliction of emotional distress, any and all tort claims for personal injury, claims or demands related to salary, bonuses, commissions, stock, stock options, or any other ownership interests in the Company, vacation pay, fringe benefits, expense reimbursements, severance pay, or any other form of disputed compensation; claims pursuant to any federal, state or local law or cause of action including, but not limited to, the federal Civil Rights Act of 1964, as amended; the federal Age Discrimination in Employment Act of 1967, as amended (“ADEA”); the federal Employee Retirement Income Security Act of 1974, as amended; the federal Americans with Disabilities Act of 1990; the federal Worker Adjustment and Retraining Notification Act of 1988; the California Fair Employment and Housing Act, as amended; tort law; contract law; statutory law; common law; wrongful discharge; discrimination; fraud; defamation; emotional distress; and breach of the implied covenant of good faith and fair dealing; provided, however, that nothing in this paragraph shall be construed in any way to

 

1



 

release the Company from its obligation to indemnify me pursuant to the Company’s indemnification obligation pursuant to agreement or applicable law.

 

I acknowledge that I am knowingly and voluntarily waiving and releasing any rights I may have under ADEA.  I also acknowledge that the consideration given under the Agreement for the waiver and release in the preceding paragraph hereof is in addition to anything of value to which I was already entitled.  I further acknowledge that I have been advised by this writing, as required by the ADEA, that:  (A) my waiver and release do not apply to any rights or claims that may arise on or after the date I execute this Release; (B) I should consult with an attorney prior to executing this Release; (C) I have twenty-one (21) days to consider this Release (although I may choose to voluntarily execute this Release earlier); (D) I have seven (7) days following the execution of this Release by the parties to revoke the Release; and (E) this Release shall not be effective until the date upon which the revocation period has expired, which shall be the eighth day after this Release is executed by me.

 

 

 

 

[NAME OF EMPLOYEE]

 

 

 

 

 

 

 

 

Date:

 

 

 

 

2



 

For Employees Age 40 and Older

Group Termination

 

EXHIBIT B

 

RELEASE

 

Certain capitalized terms used in this Release are defined in the Amylin Pharmaceuticals, Inc. Officer Change in Control Severance Benefit Plan (the “Plan”) which I have reviewed.

 

I hereby confirm my obligations under the Company’s proprietary information and inventions agreement.

 

I understand that this Release, together with the Plan, constitutes the complete, final and exclusive embodiment of the entire agreement between the Company, affiliates of the Company and me with regard to the subject matter hereof.  I am not relying on any promise or representation by the Company that is not expressly stated therein.

 

I acknowledge that I have read and understand Section 1542 of the California Civil Code which reads as follows: “A general release does not extend to claims which the creditor does not know or suspect to exist in his favor at the time of executing the release, which if known by him must have materially affected his settlement with the debtor.”  I hereby expressly waive and relinquish all rights and benefits under that section and any law of any jurisdiction of similar effect with respect to my release of any claims I may have against the Company.

 

Except as otherwise set forth in this Release, I hereby release, acquit and forever discharge the Company, its parents and subsidiaries, and their officers, directors, agents, servants, employees, shareholders, successors, assigns and affiliates, of and from any and all claims, liabilities, demands, causes of action, costs, expenses, attorneys fees, damages, indemnities and obligations of every kind and nature, in law, equity, or otherwise, known and unknown, suspected and unsuspected, disclosed and undisclosed (other than any claim for indemnification I may have as a result of any third party action against me based on my employment with the Company), arising out of or in any way related to agreements, events, acts or conduct at any time prior to the date I execute this Release, including, but not limited to:  all such claims and demands directly or indirectly arising out of or in any way connected with my employment with the Company or the termination of that employment, including but not limited to, claims of intentional and negligent infliction of emotional distress, any and all tort claims for personal injury, claims or demands related to salary, bonuses, commissions, stock, stock options, or any other ownership interests in the Company, vacation pay, fringe benefits, expense reimbursements, severance pay, or any other form of disputed compensation; claims pursuant to any federal, state or local law or cause of action including, but not limited to, the federal Civil Rights Act of 1964, as amended; the federal Age Discrimination in Employment Act of 1967, as amended (“ADEA”); the federal Employee Retirement Income Security Act of 1974, as amended; the federal Americans with Disabilities Act of 1990; the federal Worker Adjustment and Retraining Notification Act of 1988; the California Fair Employment and Housing Act, as amended; tort law; contract law; statutory law; common law; wrongful discharge; discrimination; fraud; defamation; emotional distress; and breach of the implied covenant of good faith and fair dealing; provided, however, that nothing in this paragraph shall be construed in any way to

 

1



 

release the Company from its obligation to indemnify me pursuant to the Company’s indemnification obligation pursuant to agreement or applicable law.

 

I acknowledge that I am knowingly and voluntarily waiving and releasing any rights I may have under ADEA.  I also acknowledge that the consideration given under the Agreement for the waiver and release in the preceding paragraph hereof is in addition to anything of value to which I was already entitled.  I further acknowledge that I have been advised by this writing, as required by the ADEA, that:  (A) my waiver and release do not apply to any rights or claims that may arise on or after the date I execute this Release; (B) I should consult with an attorney prior to executing this Release; (C) I have forty-five (45) days to consider this Release (although I may choose to voluntarily execute this Release earlier); (D) I have seven (7) days following the execution of this Release by the parties to revoke the Release; (E) this Release shall not be effective until the date upon which the revocation period has expired, which shall be the eighth day after this Release is executed by me; and (F) I have received with this Release a detailed list of the job titles and ages of all employees who were terminated in this group termination and the ages of all employees of all employees in the same job classification or organizational unit who were not terminated.

 

 

 

 

[NAME OF EMPLOYEE]

 

 

 

 

 

 

 

 

Date:

 

 

 

 

2



 

For Employees Under Age 40

Individual and Group Termination

 

EXHIBIT C

 

RELEASE

 

Certain capitalized terms used in this Release are defined in the Amylin Pharmaceuticals, Inc. Officer Change in Control Severance Benefit Plan (the “Plan”) which I have reviewed.

 

I hereby confirm my obligations under the Company’s proprietary information and inventions agreement.

 

I understand that this Release, together with the Plan, constitutes the complete, final and exclusive embodiment of the entire agreement between the Company, affiliates of the Company and me with regard to the subject matter hereof.  I am not relying on any promise or representation by the Company that is not expressly stated therein.

 

I acknowledge that I have read and understand Section 1542 of the California Civil Code which reads as follows: “A general release does not extend to claims which the creditor does not know or suspect to exist in his favor at the time of executing the release, which if known by him must have materially affected his settlement with the debtor.”  I hereby expressly waive and relinquish all rights and benefits under that section and any law of any jurisdiction of similar effect with respect to my release of any claims hereunder.

 

Except as otherwise set forth in this Release, I hereby generally and completely release the Company, the Employers and their parents, subsidiaries, successors, predecessors and affiliates, and its and their partners, members, directors, officers, employees, stockholders, shareholders, agents, attorneys, predecessors, insurers, affiliates and assigns, from any and all claims, liabilities and obligations, both known and unknown, that arise out of or are in any way related to events, acts, conduct, or omissions occurring at any time prior to and including the date I sign this Release.  This general release includes, but is not limited to: (a) all claims arising out of or in any way related to my employment with the Company, the Employers or their affiliates, or the termination of that employment; (b) all claims related to my compensation or benefits, including salary, bonuses, commissions, vacation pay, expense reimbursements, severance pay, fringe benefits, stock, stock options, or any other ownership interests in the Company, the Employers, or their affiliates; (c) all claims for breach of contract, wrongful termination, and breach of the implied covenant of good faith and fair dealing; (d) all tort claims, including claims for fraud, defamation, emotional distress, and discharge in violation of public policy; and (e) all federal, state, and local statutory claims, including claims for discrimination, harassment, retaliation, attorneys’ fees, or other claims arising under the federal Civil Rights Act of 1964 (as amended), the federal Americans with Disabilities Act of 1990 (as amended), the federal Age Discrimination in Employment Act (as amended) (“ADEA”), the federal Employee Retirement Income Security Act of 1974 (as amended), and the California Fair Employment and Housing Act (as amended); provided, however, that nothing in this paragraph shall be construed in any way to release the Company or its affiliates from its obligation to indemnify me pursuant to agreement or applicable law.

 

1



 

I acknowledge that to become effective, I must sign and return this Release to the Company so that it is received not later than fourteen (14) days following the date it is provided to me.

 

 

EMPLOYEE

 

 

 

 

 

Name:

 

 

 

 

 

Date:

 

 

2



EX-10.28 3 a2190933zex-10_28.htm EXHIBIT 10.28

Exhibit 10.28

 

Summary Description of Named Executive Officer
Oral At-Will Employment Agreement

 

With the exception of Daniel M. Bradbury, our President and Chief Executive Officer, with whom we have a written employment agreement, we maintain oral at-will employment relationships with each of our other currently-serving named executive officers: Mark G. Foletta, Orville G. Kolterman, M.D., Marcea Bland Lloyd and Roger Marchetti. Each of these executive officers receives our normal and customary employment benefits, generally on the same terms as all of our employees. The benefits include the right to (i) participate in our 401(k) Plan and our Employee Stock Purchase Plan, (ii) receive 10% of eligible compensation in the form of Amylin common stock under our Employee Stock Ownership Plan and (iii) receive stock option grants under our Equity Incentive Plan and cash bonuses under our cash bonus plan. The cash bonus plan is called the Executive Cash Bonus Plan when it applies to those employees with the title of executive director or above.  In 2008 each of our named executive officers voluntarily waived any right to receive an annual cash bonus payout. Each of these executive officers is also eligible, along with all of our employees holding the title of vice-president and above, to participate in our Deferred Compensation Plan and our Officer Change in Control Severance Benefit Plan. The Change in Control Plan provides each participant with certain benefits in the event such employee ceases employment with Amylin without cause or under certain specified circumstances and within 90 days prior to, or within 13 months following specified change of control transactions.  In such event, (i) the president and chief executive officer would receive salary continuation for 36 months and three times his annual target bonus; (ii) executive officers would receive salary continuation for 24 months and two times their annual target bonus, and (iii) non-executive officers would receive 18 months salary continuation and an amount equal to their annual target bonus.  Under the Change in Control Plan, officers would also receive 18 months of COBRA payment reimbursement.  We also have customary indemnification agreements with our officers, including these executive officers. In addition, the Compensation and Human Resources Committee of our Board of Directors reviews the salaries of our executive officers from time to time.  Mr. Bradbury’s annual salary is currently set at $675,000. Annual salaries for each of our other named executives are currently set as follows:  Dr. Kolterman - - $440,000, Mr. Foletta - $419,000, Ms. Lloyd - $400,125 and Mr. Marchetti - - $360,400.

 



EX-10.43 4 a2190933zex-10_43.htm EXHIBIT 10.43

Exhibit 10.43

 

EXECUTION COPY

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)
and 240.24b-2

 

EXENATIDE ONCE WEEKLY SUPPLY AGREEMENT

 

This EXENATIDE ONCE WEEKLY SUPPLY AGREEMENT (“Agreement”) is entered into as of October 16, 2008, by and between Amylin Pharmaceuticals, Inc. (“Amylin”), a Delaware corporation, and Eli Lilly and Company (“Lilly”), a corporation organized and existing under the laws of the State of Indiana. Amylin and Lilly are sometimes referred to herein individually as a “Party” and collectively as “Parties”. References to “Amylin” and “Lilly” and “Party” or “Parties” shall include their respective Affiliates.

 

RECITALS

 

1.                                       Amylin and Lilly are parties to that certain Collaboration Agreement, effective September 19, 2002, as amended to date, pursuant to which Amylin and Lilly have agreed to cooperate in the development, manufacturing and marketing of Exenatide Once Weekly (the “EQW Product”, as defined below).

 

2.                                       Under the terms of the Collaboration Agreement, Amylin is responsible for sale of EQW Product in the U.S. and Lilly is responsible for the sale of EQW Product in the Territory outside the U.S.

 

3.                                       In furtherance of the goals set forth in the Collaboration Agreement, the Parties desire to enter into this Agreement whereby Lilly will agree to purchase from Amylin and Amylin will agree to supply to Lilly the EQW Product in commercial quantities intended for commercial sale in the Territory outside the U.S., all on the terms and conditions set forth herein. In addition, the Parties desire to define how certain costs and expenses will be applied and allocated for EQW Product intended for commercial sale in the U.S.

 

1



 

AGREEMENT

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained in this Agreement, the Parties hereby agree as follows:

 

ARTICLE 1
DEFINITIONS
 

 

When used and capitalized in this Agreement (other than the headings of the Articles and Sections), including the foregoing Recitals, the following terms will have the meanings assigned to them in this Article 1 and include the plural as well as the singular. Capitalized terms not otherwise defined herein will have the meaning assigned to them in the Collaboration Agreement.

 

1.1                               “Actual Component Manufacturing Cost” means those costs actually incurred by Amylin for the acquisition and release of Components from Third Party Suppliers, including an appropriate allocation of any overhead costs. Such costs include, but are not limited to:  (i) the landed cost of purchased materials, including, without limitation, invoice price, outside processing costs, freight, duties, storage fees and brokers fees (volume or trade discounts will be reflected in the calculation); (ii) conversion costs (including, without limitation, direct labor and direct overhead) directly associated with the releasing and shipping of Components;  (iii) replacement costs for Components that are determined to be defective or recalled during the quality control process or for Components that are returned to Amylin from Lilly or to Third Party Suppliers from Amylin; (iv) Component breakage, damage and manufacturing losses; (v) obsolete Components; and (vi) to the extent attributable to the acquisition of Components, any other costs considered inventory costs or Costs of Products Sold under Generally Accepted Accounting Principles. Amylin shall share details relating to the Actual Component Manufacturing Cost in detail and frequency as Lilly may reasonably request.

 

1.2                               “Actual Manufacturing Cost” means those costs actually incurred by Amylin or Lilly for the acquisition of materials from Third Party Suppliers or Lilly, and Manufacture and conversion into EQW Product. Such costs include, but are not limited to:

 

(a)                                  the landed cost of purchased materials, including, without limitation, invoice price, outside processing costs, freight, duties, and brokers fees (volume or trade discounts will be reflected in the calculation);

 

2



 

(b)                                 conversion costs directly associated with the Manufacture of EQW Product at the Facility including direct labor and direct overhead costs;

 

(c)                                  an appropriate allocation of the actual indirect overhead costs directly associated with the Manufacture of EQW Product incurred by Amylin at the Facility;

 

(d)                                 an appropriate allocation of costs based on actual headcount and actual FTE rate incurred by Amylin  outside of the Facility but directly associated with  the Manufacture of EQW Product, including but not limited to those items as set forth on Exhibit A;

 

(e)                                  depreciation of EQW Product-specific capital investments at the Facility (not including the financing charge for the Initial Capital Investment or depreciation of capitalized interest for the capital investments made at the Facility);

 

(f)                                    EQW Product breakage, damage and Manufacturing losses;

 

(g)                                 an allocation of the depreciation of those capital investments net of capitalized interest in and for Amylin’s San Diego Quality Control Laboratory to the extent such capital investments directly support Manufacture of the EQW Product;

 

(h)                                 an allocation of depreciation of those capital investments located at Third Party Suppliers but owned by Amylin to the extent such capital investments directly support Manufacture of the EQW Product;

 

(i)                                     replacement costs for EQW Product that is determined to be defective or recalled during the quality control process or for EQW Product that is returned to Amylin from Lilly or any customer or to Third Party Suppliers from Amylin;

 

(j)                                     amortization of any pre-paid assets of Amylin at a Third Party Supplier in accordance with the terms of the agreement with any such Third Party Supplier, as well as an appropriate carrying cost of such prepaid assets calculated in accordance with Section 1.2(l) below;

 

(k)                                  to the extent attributable to the Manufacture of EQW Product, any other costs considered inventory costs or Costs of Products Sold under Generally Accepted Accounting Principles;

 

(l)                                     an appropriate carrying cost applied to the ending monthly inventory utilizing the interest rate agreed to in the letter agreement between the Parties dated June 12, 2006 (the “Letter Agreement”); and

 

3



 

(m)                               an allocation of Lilly resources directly associated with  Manufacture of EQW Product charged at the actual FTE rate and any other expenses incurred by Lilly directly associated with the Manufacture of EQW Product as agreed to in advance by the Parties.

 

All of these costs and the methodology to be used in allocating indirect or overhead costs among Manufacturing operations hereunder and other Amylin manufacturing operations, and among EQW Product Manufactured pursuant to this Agreement shall be determined in a manner consistent with Generally Accepted Accounting Practices, except as expressly set forth herein or as otherwise agreed by the Parties. Amylin shall share reasonable details relating to the Actual Manufacturing Cost. The Parties agree to annually review the interest rate set forth in the Letter Agreement and Section 1.2(l) above.

 

For the avoidance of any doubt, the Actual Manufacturing Costs for EQW Product sold either in the U.S. or in the Territory outside the U.S. shall be calculated using the same methodology through the nude vial stage of production, with the exception that any OUS-specific costs (e.g., OUS-specific analytical testing) would be charged [***]% to OUS Product. Following the nude vial stage of production, product destined for the US market would incur additional costs related to subsequent steps in the manufacturing process including, but not limited to, labeling, packaging, storage and distribution and would be charged [***]% to US Product. Revisions to allocations and methodology will not be made during the year without the approval of the MSC.

 

Any incremental costs for the Manufacture of EQW Product for which the primary benefit of such cost will be in a Territory outside the U.S. shall be attributed [***]% to the Actual Manufacturing Cost for the EQW Product to be sold in the Territory outside the U.S. and paid by Lilly hereunder if agreed to in advance by the Parties. Likewise, any incremental costs for the Manufacture of EQW Product for which the primary benefit of such cost will be the U.S. Territory, such as packaging, shall be attributed one hundred percent ([***]%) to the Actual Manufacturing Cost  for the EQW Product to be sold in the U.S. if agreed to in advance by the Parties.

 

The foregoing definition of Actual Manufacturing Cost assumes all of the manufacturing capacity of the Facility will be used to Manufacture EQW Product; if at any time during the term of this Agreement this is not the case, then this definition shall be modified as set forth in Section 4.9(b) below.

 

1.3                               “Applicable Laws” means all applicable U.S. statutes, ordinances, regulations, rules or orders, including, without limitation, the FD&C Act, the Regulatory Law, Prescription

 

***Confidential Treatment Requested

 

4



 

Drug Marketing Act, Generic Drug Enforcement Act of 1992 (21 U.S.C. §3359, et. seq.), Anti-Kickback Statute (42 U.S.C. §1320 a-7b, et. seq.), Resource Conservation and Recovery Act, Clean Water Act, Clean Air Act, the Drug Enforcement Act, Occupational Safety and Health Act and cGMP, as well as comparable laws of the European Union, all as amended from time to time.

 

1.4                               “ASC” will have the meaning set forth in Section 2.1 of this Agreement.

 

1.5                               “Cartridge Supply Agreement” means the Cartridge Supply Agreement, by and between Amylin and Lilly, dated as of April 20, 2007.

 

1.6                               “cGMP” will mean current Good Manufacturing Practices as detailed in “The Rules Governing Medicinal Products in the European Community (EC) — Volume IV: Guide to Good Manufacturing Practice for Medicinal Products” and the “US Current Good Manufacturing Practices (cGMPs) for Finished Pharmaceuticals: 21 Code of Federal Regulations (CFR) Parts 11, 210 and 211, all as amended from time to time, and any additional cGMPs promulgated by any regulatory authority not described above and provided to Amylin by Lilly and mutually agreed to between the Parties.

 

1.7                               “Collaboration Agreement” means the Collaboration Agreement set forth in the Recitals of this Agreement, as such agreement may be amended from time to time.

 

1.8                               “Components” means diluent, needles, stoppers, plungers, backstops, packaging materials, and any other items as may be agreed to by the MSC.

 

1.9                               “Effective Date” will have the meaning set forth in Section 16.17 of this Agreement.

 

1.10                        “EQW Manufacturing Development Costs” shall mean those Development Costs specifically related to developing the ability to Manufacture EQW Product, including, without limitation, Manufacturing process development and Manufacturing and quality assurance technical support, until such time as Manufacturing of EQW Product intended for commercial sale commences. For purposes of clarification, EQW Manufacturing Development Costs shall not include any Development Costs which are solely attributable to clinical studies of EQW Product, but may include costs relating to manufacturing development irrespective of where those costs were incurred. All Amylin and Lilly personnel costs, including without limitation direct and indirect personnel costs, will be charged at actual FTE cost.

 

1.11                        “EQW Product” means the Product (whether to be used as trade, sample or clinical trial material) or placebo developed as a fixed-dose injection of exenatide administered once per week for diabetes and any other Indications for which such Product may be approved

 

5



 

for use and Manufactured by Amylin in finished form or in nude vials, including any components thereof and associated packaging components.

 

1.12                        “Facility” means the manufacturing facility commissioned by Amylin and located at 8814, 8848 and 8874 Trade Port Drive, West Chester, Ohio, as such facility may be from time to time approved, expanded or altered in accordance with this Agreement.

 

1.13                        “Five-Year Forecast” will have the meaning set forth in Section 5.1(a) of this Agreement.

 

1.14                        “Force Majeure” will have the meaning set forth in Section 16.14 of this Agreement.

 

1.15                        “Forecast” will have the meaning set forth in Section 5.1 (b) of this Agreement.

 

1.16                        “Initial Capital Investment” shall mean the capital investment made, and planned to be made, as of the Effective Date by Amylin in and for the Facility for the Manufacture of the first generation EQW Product. The Initial Capital Investment is currently anticipated to be approximately $530 million; however, a precise number will not be available until the Facility is complete. A detailed estimate of the Initial Capital Investment, including anticipated costs of equipment and estimates of their related useful life, is set forth on Exhibit B.

 

1.17                        “Latent Defect” means defects that cause the EQW Product to fail to conform to the Specifications or otherwise fail to conform to the warranties provided pursuant to Section 10.8 (hereof, which defects are not discoverable upon reasonable physical inspection as provided in Section 5.8(a).

 

1.18                        “Manufacture”, “Manufacturing” or “Manufactured” means all operations involved in the manufacturing, quality control testing (including in-process, disposition and stability testing), disposition (releasing or rejecting), packaging and shipping of the EQW Product as more fully described in the MRD.

 

1.19                        “MRD” means the Manufacturing Responsibilities Document, which sets forth written instructions regarding the Manufacture and other technical matters including, without limitation, testing procedures and supply of the EQW Product under this Agreement. The Table of Contents of a sample MRD is attached for reference only as Exhibit C.

 

1.20                        “MSC” will have the meaning set forth in Section 2.1 of this Agreement.

 

1.21                        “Party” or “Parties” will have the meaning set forth in the first paragraph of this Agreement.

 

6



 

1.22                        “Purchase Order” will have the meaning set forth in Section 5.4 of this Agreement.

 

1.23                        “QLT” will have the meaning set forth in Section 2.3 of this Agreement.

 

1.24                        “Quality Agreement” means the quality agreement, as revised and amended from time to time between the Parties, that describes certain quality expectations and responsibilities relating to the Manufacture, release testing and supply of the EQW Product to Lilly. The Parties acknowledge that, if they so elect, there will be one Quality Agreement applicable for EQW Product intended to be Commercialized in the U.S. and another Quality Agreement applicable for EQW Product intended to be Commercialized in the Territory outside the U.S. Exhibit D sets forth the areas to be addressed by the Parties in the Quality Agreement.

 

1.25                        “Quality Audit” will have the meaning set forth in Section 4.5(b) of this Agreement.

 

1.26                        “QWT” will have the meaning set forth in Section 2.3 of this Agreement.

 

1.27                        “Regulatory Authority” will have the meaning set forth in Section 1.97 of the Collaboration Agreement.

 

1.28                        “Regulatory Lead” will have the meaning set forth in Section 5.2(a) of the Collaboration Agreement.

 

1.29                        “SCWT” will have the meaning set forth in Section 2.2 of this Agreement.

 

1.30                        “Specifications” for EQW Product means the specifications and quality control testing procedures for the development, Manufacturing, final release and testing of EQW Product and labeling and packaging requirements, which may cover one or more versions of the EQW Product including, without limitation, EQW Product having different physical features as set forth in the applicable Marketing Approvals, as the same may be modified from time to time by the Parties in accordance with the terms of the Agreement. The Specifications will be agreed to in accordance with the terms of the Quality Agreement.

 

1.31                        “Standard Cost” means the planned EQW Product Manufacturing costs for each SKU divided by the production volume for such SKU as agreed to by the Parties as part of the annual plan.

 

1.32                        “Successor Manufacturer” will have the meaning set forth in Section 11.4(e) of this Agreement.

 

7



 

1.33                        “Third Party Supplier” shall have the meaning set forth in Section 4.7 of this Agreement.

 

ARTICLE 2

GOVERNANCE

 

2.1                               Governance of Activities. Lilly acknowledges that Amylin shall be responsible for day-to-day operational management of the Facility within the agreed-upon annual plan. Governance of activities contemplated by this Agreement will be effected through the governance structure established by the Parties, including the SCWT, the QLT, the Manufacturing Strategy Committee (the “MSC”) and the Alliance Steering Committee (the “ASC”). The Parties intend that MSC shall be responsible for oversight of the Facility and the complete EQW Product supply chain, including, but not limited to the following items:

 

(a)                                  output requirements of the Facility;

 

(b)                                 operational performance to plan or revised forecast;

 

(c)                                  establishing and overseeing sub-committees, as it deems necessary;

 

(d)                                 major capital projects;

 

(e)                                  annual and long range plans for EQW Product supply; and

 

(f)                                    sourcing and supply agreements.

 

The MSC shall also be responsible for reviewing and recommending for approval annual budgets and capital investments to the ASC under the timing described for Binding Budgets in the Collaboration Agreement. MSC shall meet no less than four times per year with agendas and pre-reads due at least five days in advance of the meeting or as directed by the MSC.

 

The MSC will establish governance processes which define how information (financials, operational performance, inventories, capital spend, etc.) will be reported and reviewed on a periodic basis (initially proposed to be monthly). MSC will also define the types and magnitude of decisions that it will delegate to SCWT or other sub-committees and which are required to be agreed upon by the Parties through the MSC structure.

 

8



 

In the event that the parties, through the SCWT or other sub-committees as established by the MSC, are unable to resolve any dispute in connection with this Agreement, the SCWT or sub-committee shall refer such dispute to the MSC. In the event that the parties, through the MSC, are unable to resolve any dispute in connection with this Agreement, the MSC shall refer such dispute to the ASC which has been established by mutual understanding between the Parties in performance of their obligations under other agreements between the Parties. If the issue can not be resolved by the ASC, then it shall be escalated to the Chief Executive Officer of Amylin and an Executive Committee Member from Lilly.

 

2.2                               Supply Chain Working Team. The Parties have established a supply chain working team for the EQW Product (the “SCWT”). The function of the SCWT shall be to plan, coordinate and manage supply chain activities for EQW Product, develop a risk management plan related to ensuring supply of EQW Product, review operational performance of supply chain activities, engage in appropriate activities to reduce supply chain costs, establish customer service levels, serve as a forum for communication for any supply chain issues, and resolve disputes related to supply chain issues between the Parties.

 

The SCWT will meet at such other times as are agreed to by the Parties, but no less than once each quarter. Such meetings may be in-person, via video conference, or via telephone conference. At least five (5) business days prior to each SCWT meeting, each Party will provide written notice to the other Party of agenda items proposed by such Party for discussion or decision at such meeting, together with appropriate information related thereto. Written minutes will be kept of all SCWT meetings and will reflect, without limitation, material decisions made at such meetings. Responsibility for keeping minutes will alternate between the Parties.

 

2.3                               Quality Governance. The Parties have established an Alliance Quality Working Team (the “QWT”) that meets on a regular basis to discuss and resolve quality-related issues and to review data and/or perform the activities outlined in the Quality Agreement. Pursuant to the Quality Agreement, the Parties have also established an Alliance Quality Lead Team (the “QLT”) responsible for strategic quality issues that arise with respect to the EQW Product. In the event that the QWT is unable to resolve any quality-related disputes, the QWT shall refer such dispute to the QLT. Further, if the QLT is unable to resolve such dispute, the QLT shall refer such dispute to the head of each Party’s Quality

 

9



 

Department for resolution. If despite their best efforts, the head of each Party’s Quality Department are unable to resolve such dispute, they shall refer such dispute to the MSC for resolution.

 

ARTICLE 3

PAYMENT OF DEVELOPMENT EXPENSES, PURCHASE AND SUPPLY OF EQW PRODUCT AND COMPONENTS AND LIMITATION OF AGREEMENT

 

3.1                               EQW Manufacturing Development Costs. Notwithstanding anything to the contrary in the Collaboration Agreement or any previous formal or informal agreements between the Parties, the Parties agree that Lilly shall be responsible for [***]% of EQW Manufacturing Development Costs incurred up until commercial Manufacture of EQW product commences and Amylin shall be responsible for [***]% of EQW Manufacturing Development Costs incurred up until commercial Manufacture of EQW product commences. Going forward, the MSC shall determine if EQW Development Costs relate to developing capabilities to Manufacture for the U.S. and OUS markets or solely for either the US or OUS market.

 

3.2                               Purchase of EQW Product Requirements. Subject to the terms and conditions of this Agreement, Amylin will Manufacture EQW Product for worldwide distribution; provided, however, that Amylin will not have any responsibility to package EQW Product for the territory outside of the U.S. Lilly shall purchase from Amylin, and Amylin shall supply and deliver to Lilly, Lilly’s requirements for the EQW Product for sale by Lilly in the territory outside the U.S. in accordance with Article 5 of this Agreement. If at any time Amylin is not able to provide Lilly with the quantity of EQW Lilly desires to purchase in accordance herewith because of the capacity limitations of the Facility, the Parties agree to discuss in good faith how best to provide such additional quantities of EQW Product including, without limitation, increasing the capacity of the Facility and/or securing a Third Party manufacturer (including, without limitation, Lilly) for EQW Product.

 

3.3                               US EQW Cost. The Cost of Product Sold to be allocated to Adjusted US Operating Profit/Loss for any quarter as contemplated by Section 4.5(a) of the Collaboration Agreement for EQW Product shipped to non-Amylin, US distribution sites shall be based on the Standard Cost plus any US specific costs and the US pro-rata portion of any variances for such quarter.

 

***Confidential Treatment Requested

 

10


 

3.4                               OUS EQW Product Purchase Price. Lilly shall purchase EQW Product from Amylin at a price per unit equal to the Standard Cost plus any OUS specific costs and the OUS pro-rata portion of any variances for such quarter. The purchase price for EQW Product purchased by Lilly in each quarter will be included as part of the periodic reconciliation of Operating Profits or Loss for such quarter as contemplated in Section 4.9 of the Collaboration Agreement.

 

3.5                               [***] True-Up.

 

(a)  Within [***] after the end of each [***], Amylin shall calculate [***] Average Unit Cost”. The [***] Average Unit Cost for any [***] shall be the quotient of (i) the Actual Manufacturing Costs up through the nude vial stage minus any US or OUS-specific costs divided by (ii) the total number of EQW Product units Manufactured in such [***]. To the extent the average purchase price per unit for any [***] paid by Lilly pursuant to Section 3.4 differs from the [***] Average Unit Cost plus OUS-specific costs for such [***], such difference will be included in the periodic reconciliation of Operating Profits or Loss for the [***] as contemplated in Section 4.9 of the Collaboration Agreement.

 

(b)  In addition, within [***] after the end of each calendar year, the Parties agree to true-up the inventory carrying costs for the previous [***] by re-calculating each [***] ending EQW Product inventory balance for the previous [***] utilizing the Actual Manufacturing Cost in lieu of the Standard Cost.

 

3.6                               Purchase of Components. Lilly will define those components it chooses to purchase through Amylin for the OUS market. Upon agreement at the SCWT and subject to the terms and conditions of this Agreement, Lilly shall purchase from Amylin, and Amylin shall cause to be delivered by the applicable Third-Party Supplier to Lilly, Lilly’s requirements for any applicable Components needed for final packaging that are not included in the EQW Product delivered to Lilly by Amylin, all for sale by Lilly in the territory outside the U.S. and in accordance with Article 5 of this Agreement. If at any time a Third-Party Supplier is not able to provide Lilly with the quantity of Components Lilly desires to purchase in accordance herewith, the Parties will allocate supply following the procedures set forth in Section 5.3, below.

 

3.7                               Component Purchase Price. Lilly shall purchase any Components from Amylin at a price per unit of such Component equal to the Actual Component Manufacturing Cost for such Component.

 

***Confidential Treatment Requested

 

11



 

Purchase Orders, as defined below, for Components will be submitted by Lilly within [***] after the beginning of each [***] using a price provided by Amylin based upon Amylin’s good faith estimate of the Actual Component Manufacturing Cost for such Components for such [***]. Actual Component Manufacturing Costs for Components purchased by Lilly in each [***] will be included as part of the periodic reconciliation of Operating Profits or Loss for such [***] as contemplated in Section 4.9 of the Collaboration Agreement.

 

3.8                               Capital Investments. The Initial Capital Investment made by Amylin for the capital assets will be depreciated and included in the Actual Manufacturing Costs as set forth in Article 1, but such depreciation will not include a financing charge or capitalized interest for the investment in the Facility, but may include capitalized interest for investments outside the Facility. Any additional capital investments beyond the Initial Capital Investment for Manufacturing of the EQW Product will be based upon the Forecast and the [***] Forecast discussed in Section 5.1, below, recommendations of the SCWT and the MSC, and the approval of the ASC. Projects will be grouped into two categories:  projects with a scope less than [***] each (collectively, “Minor Projects”), and projects with a scope greater than or equal to [***] each (collectively, “Major Projects”). Projects classified as Minor but with an anticipated spend greater than [***] must be listed individually. Amylin may spend money on Minor Projects included in the first year Budget Summary without prior approval by MSC. Amylin at their sole discretion may make trade-off decisions for Minor Projects not included in the Budget Summary provided (i) the spend for Minor Projects does not exceed the total approved Minor Project Budget amount for that [***] and (ii) the trade-off does not replace a capital asset required to meet Regulatory requirements. Spend for Major Projects must be approved by the MSC prior to initiation of the project regardless of whether the Project was included in the Budget Summary or not. MSC will take action on such requests for approvals on a timely basis.

 

3.9                               Reimbursement for Financing Charge. Exhibit E sets forth the terms by which Lilly will reimburse Amylin for Lilly’s portion of the financing charges Amylin has incurred or will incur in making the Initial Capital Investment in preparation for the Manufacture of EQW Product at the Facility.

 

3.10                        Impairment. To the extent any or all of the Facility cannot be used for the Manufacture of EQW, the Parties shall meet to discuss the potential impairment of the Facility and the capital investments made outside the Facility for the Manufacture of EQW. Exhibit F sets forth the capital investments outside the Facility for the Manufacture of EQW as of

 

***Confidential Treatment Requested

 

12



 

the date hereof. If the Parties agree to take an impairment charge relating to the Facility and/or the capital investments made outside the Facility for the Manufacture of EQW, Lilly will pay to Amylin an amount equal to either (i) in the event the impairment charge is taken prior to the True-Up Date (as defined in Exhibit E), [***], or (ii) in the event the impairment charge is taken after the True-Up Date, the Lilly Percentage (as defined in Exhibit E) of any impairment charge determined in accordance with GAAP for all  non-depreciated capital investments in and for the Facility and the Manufacture of EQW less:  (a) such portion of the financing charge for the Initial Capital Investment that has not yet been amortized in accordance with Exhibit G, (b) any amount due to Lilly under the Loan Agreement, plus any and all outstanding interest thereon, (c) any other amounts due and payable to Lilly from Amylin at the time of the impairment charge; and (d) any amounts for any assets that can otherwise be utilized for other uses by Amylin; plus any other amounts due and payable to Amylin from Lilly at the time of impairment charge. In the event any amounts are recovered by Amylin after the impairment charge, such amounts shall be allocated between Lilly and Amylin in the same proportions as the impairment charge.

 

3.11                        Audits. Each Party will have the right to audit the other Party’s financial books and records relating to this Agreement and the calculation of Actual Manufacturing Cost under the same terms and in the same manner as set forth in Section 4.9(e) of the Collaboration Agreement. Notwithstanding the foregoing, any non-financial audit conducted by Lilly under this Agreement shall not count towards the annual limitation of one (1) audit per year set forth in Section 4.9(e) of the Collaboration Agreement.

 

3.12                        Reporting.

 

(a)                                  Estimate of Actual Manufacturing Costs. Amylin will provide to Lilly a report containing a good faith estimate of the Actual Manufacturing Cost, in a format similar to and with the similar detail as set forth in Exhibit H, within [***] prior to the end of each [***].

 

(b)                                 Actual Manufacturing Costs. Amylin will provide to Lilly a report containing the Actual Manufacturing Cost, in a format similar to and with the similar detail set forth in Exhibit H, within [***] after the end of each [***].

 

(c)                                  Budget and Long Range Plan. MSC will establish and maintain business processes to develop and monitor budgets, plans and long-range plans.

 

***Confidential Treatment Requested

 

13



 

1.               Budget Summary. On an [***], a budget summary shall be developed covering the following [***]. Such budget shall reflect Amylin’s plan at the time such budget is created, but shall not be binding on Amylin. MSC shall  review on no less than [***] the actual performance relative to the plan and shall agree upon any actions needed.

 

2.              Long-Range Plan. On an [***], a long-range plan for anticipated EQW Product demand, capital and manufacturing costs will be developed, reviewed and approved by MSC.

 

ARTICLE 4
MANUFACTURING AND QUALITY

 

4.1                               Quality Agreement. No later than [***] after the Effective Date, the parties shall prepare and adopt the Quality Agreement. The Parties shall review the Quality Agreement at least once [***] and shall modify it from time to time as necessary through issuance of a revised version of the Quality Agreement signed on behalf of each of the Parties by an authorized representative incorporating the modification and stating the effective date and revision number of the modification. The Quality Agreement will be subject to and not inconsistent with the terms of this Agreement, the Collaboration Agreement and the Specifications. In the event the information in the Quality Agreement on the one hand, and this Agreement, the Collaboration Agreement or the Specifications, as applicable, on the other hand, conflict, this Agreement, the Collaboration Agreement or the Specifications, as applicable, will control; provided, however that the Quality Agreement shall control for any cGMP compliance related issues.

 

4.2                               Development of MRD. No later than [***] after the Effective Date, the Parties shall prepare and adopt the MRD. The Parties shall review the MRD at least once [***] and shall modify it from time to time as necessary through issuance of a revised version of the MRD signed on behalf of each of the Parties by an authorized representative incorporating the modification and stating the effective date and revision number of the modification. The MRD will be subject to and not inconsistent with the terms of this Agreement, the Collaboration Agreement, and the Quality Agreement. In the event the information in the MRD, on the one hand, and this Agreement, the Collaboration Agreement or the Quality Agreement, on the other hand, conflict, the terms of the Collaboration Agreement, this Agreement or the Quality Agreement, as applicable, will control.

 

***Confidential Treatment Requested

 

14



 

4.3                               Manufacturing. Subject to the terms and conditions of this Agreement, Amylin will use its Commercially Reasonable Efforts to Manufacture and supply EQW Product to Lilly, at the times and in the quantities set forth by Lilly in a purchase order and subject, however, to the quantity restrictions set forth in this Agreement. Amylin will ensure that each shipment of the EQW Product delivered to Lilly:  (i) will have been manufactured in accordance with the Specifications and cGMP in effect at the time of Manufacture, (ii) will not be adulterated or misbranded within the meaning of the FD&C Act, (iii) will not have been Manufactured or sold in violation of any Applicable Laws  in any material respect, and (iv) will have been Manufactured in accordance with applicable Marketing Approvals and all regulatory requirements as defined in the applicable EQW Product registration (e.g. European dossier) as provided by Lilly to Amylin.

 

4.4                               Modifications. The Parties anticipate that the Specifications will be modified from time to time to reflect improvements or modifications to the EQW Product. Each Party will provide the other with reasonable advance notice of any proposed material modification and will consult with, and consider in good faith, the reasonable comments of such other Party regarding such proposed material modification. Any proposed modification to the Manufacturing process or Specifications shall be approved by the MSC or such subcommittee appointed by the MSC (subject to Section 5.2 of the Collaboration Agreement) prior to implementation or filing with any Regulatory Authority. Any modifications to the Manufacturing process or Specifications required by a Regulatory Authority other than the FDA or The European Medicines Agency (the “EMEA”) shall be solely paid for by Lilly. Prior to any approved change in the Manufacturing process or Specifications, the Parties shall identify, and, if needed, allocate between U.S. and O.U.S., all costs and risks, including development costs, resulting from the changes, and a timeline for implementing the changes.

 

(a)                                  Either Party will notify the other as soon as practical of any changes to any Specifications or procedures that are required by the FDA, a Regulatory Authority or Applicable Laws that could have an impact on Amylin’s performance of this Agreement. Amylin shall utilize its Commercially Reasonable Efforts to implement such changes.

 

(b)                                 In no event will Amylin be required to make a modification to the EQW Product that is prohibited by Applicable Laws or Regulatory Authorities. In no event will Amylin be prohibited from making a modification to the EQW Product that is required by Applicable Laws or Regulatory Authorities; provided, however, that Amylin shall consult with Lilly prior to making any such modification, and provided further that Amylin shall

 

15



 

use its Commercially Reasonable Efforts to implement any such modification. Any modifications to the EQW Product will be in accordance with the terms of the Quality Agreement.

 

4.5                               Audit; Safety; Applicable Laws.

 

(a)                                  Quality Control and Assurance. Amylin will perform quality control testing and quality oversight on the Product to be delivered to Lilly hereunder in accordance with this Agreement, the Quality Agreement, the MRD, Specifications and cGMP.

 

(b)                                 Quality Audit of the Facility by Lilly Representatives. Lilly shall have the right, upon no less than thirty (30) days’ notice and in accordance with the Quality Agreement, to conduct an initial OUS commercial readiness audit of the Facility during regular business hours for the purpose of conducting a quality control inspection to assure cGMP compliance of the Facility used in the Manufacturing of EQW Product to be delivered to Lilly (the “Start-Up Quality Audit”). Following the Start-Up Quality Audit, upon no less than thirty (30) days’ advance written notice to Amylin and in accordance with the terms of the Quality Agreement, no more than one (1) time per Calendar Year, Amylin will permit Lilly’s representatives (such representatives to be reasonably acceptable to Amylin) to conduct an audit of the Facility during regular business hours for the purpose of conducting a quality control inspection to assure cGMP compliance of the Facility used in the Manufacturing of EQW Product to be delivered to Lilly (the “Quality Audit”); provided, however, that such restriction of one (1) such audit per Calendar Year shall not apply in cases where Lilly attends an audit or inspection conducted by a Regulatory Authority. In addition, Lilly representatives shall have the right to re-inspect the Facility, upon reasonable advance written notice to Amylin and during regular business hours: (i) to ensure appropriate remedial actions are being taken in response to a significant adverse finding identified during a prior Lilly Quality Audit of the Facility, (ii) if an audit of the Facility conducted by a Regulatory Authority results in a critical finding, or (iii) if any EQW Product is, or has the potential to be, recalled from the market by either Amylin and/or Lilly due to Manufacturing issues. Lilly representatives will be advised of the confidentiality obligations under this Agreement, and will follow such security, safety and facility access procedures as are reasonably designated by Amylin. Amylin may require that at all times the Lilly representatives be accompanied by an Amylin representative to assure protection of Amylin Information or confidential information of a Third Person, if applicable. Amylin will respond in writing to any

 

16



 

written audit observation provided by Lilly within sixty (60) days in the form of a mutually agreed upon action plan.

 

Notwithstanding the above, Amylin shall provide Lilly with the right to conduct pre-inspection assessments and reviews of the Facility prior to the date on which a foreign regulatory agency will be conducting an EQW Product pre-approval inspection. Amylin shall reasonably cooperate with Lilly to address any needed actions identified.

 

(c)                                  Safety Procedures. Amylin will have responsibility for developing, adopting and enforcing safety procedures for the handling and production of EQW Product by Amylin and the handling and disposal of all waste relating thereto. Amylin’s responsibility for the handling of any particular EQW Product will terminate as to that particular EQW Product upon delivery thereof to Lilly’s common carrier.

 

(d)                                 Applicable Laws. Lilly and Amylin will each comply with all Applicable Laws in performing its obligations hereunder, including, without limitation, laws with respect to the protection of the environment.

 

4.6                               Access to the Facility by Lilly. Amylin will permit Lilly to appoint one (1) or more employee(s) to be its person in the plant at the Facility, who shall have reasonable access during normal business hours. The scope of such person’s role in the Facility is set forth on Exhibit I, and may be amended from time to time by MSC. The person in the plant shall have access to information that impacts budget, operational performance, and timelines. In addition, Amylin will permit a reasonable number of Lilly employees reasonable access during normal business hours to the Facility in order to observe and review the Manufacturing process. The parties acknowledge that the foregoing access rights are not intended to permit Lilly any level of audit rights in addition to those described in Section 4.5 above. Lilly will comply with Amylin’s written instructions established to enhance the safety or security of the Facility or of persons at or near the Facility.

 

4.7                               Third Party Suppliers. The Parties acknowledge that Amylin will Manufacture the EQW Product and that certain materials, including active pharmaceutical ingredient, diluents and component parts for the EQW Product and certain testing services will be purchased by Amylin from third party suppliers (“Third Party Suppliers”). The MSC shall be responsible for overseeing negotiations for any supply agreements with Third Party Suppliers not already in place as of the Effective Date (including any amendments, modifications or extensions of those already in place) in accordance with the Letter

 

17



 

Agreement between Amylin and Lilly dated January 30, 2004 except that the references to the Joint Commercialization Committee in the letter are hereby replaced by MSC. Amylin shall use its Commercially Reasonable Efforts to cause all Third Party Suppliers to fulfill their obligations under their agreements with Amylin. The Parties agree that Amylin will not be liable to Lilly, its Affiliates and their respective directors, officers, shareholders, employees or agents for any Third Party Suppliers’ failure to deliver or failure of any EQW Product as a result of materials or components manufactured by Third Party Suppliers or the failure of such materials or components to comply with applicable Specifications, any representations or warranties of such Third Party Supplier or Applicable Laws. In the event Amylin receives any indemnification payments or other recovery from Third Party Suppliers performing services on behalf of Amylin, such amounts shall be divided between Amylin and Lilly in proportion to their respective shares, at the time of the payment, of U.S. EQW Gross Profit and OUS EQW Gross Profit (less any royalty obligation to Amylin from Lilly) under the Collaboration Agreement, as amended. To the extent legally or contractually permissible, Amylin shall obtain a written assignment of all patent rights and know-how that such Third Party Suppliers may develop by reason of work performed under this Agreement.

 

4.8                               Records. Each of the Parties shall keep accurate records of its activities under this Agreement to the extent required by Applicable Law and in accordance with the Quality Agreement. Access to such records will be made available by Amylin to Lilly during normal business hours upon Lilly’s reasonable written request. The provisions of this Section 4.8 shall not supersede the audit provisions set forth in Section 4.5  Amylin further agrees to provide Lilly with such information regarding the Manufacture and testing of EQW Product hereunder as may be required to obtain or maintain Marketing Approval of EQW Product or as may otherwise be required or requested by any Regulatory Authority.

 

4.9                               Use of Facility and Adjusted Costs.

 

(a)  Use of Facility. As of the date hereof, the Parties acknowledge and agree that the Facility has been constructed for the commercialization and projected growth of EQW Product on a worldwide-demand basis. At any future date, Amylin may propose to the MSC that the Facility be used for a non-EQW Product purpose. If the Parties, through the MSC, cannot come to an agreement regarding such proposal, then the matter shall be escalated using the dispute resolution procedure set forth in the Collaboration Agreement. If the Parties’ senior executives cannot mutually resolve the matter after good faith due

 

18



 

deliberation, then Amylin shall have the final right to decide how to use the Facility subject to Section 4.9(b), below.

 

(b) Adjusted Costs. Prior to a final decision being reached on any additional non-EQW Product use(s) of the Facility, the Parties shall agree in good faith to modify the definition of Actual Manufacturing Cost set forth in Section 1.2. Any such modification to the definition of Actual Manufacturing Cost shall take into account, among other things:  (1) the actual cost of the portion of the existing Facility to be used by Amylin for any non-EQW Product use, (2) an allocation of site-wide support facilities and resources that takes into account the planned non-EQW Product use of the Facility, and (3) a prospective adjustment to the up-front financing fee Lilly has paid concurrent herewith (as described in Section 3.9). All capital expenses and costs associated with the planned non-EQW Product use of the Facility shall be Amylin’s sole responsibility

 

ARTICLE 5
PURCHASE OF EQW PRODUCT; FORECASTS

 

5.1                               Forecasts.

 

(a)                                  [***] Forecast. Lilly will submit to Amylin no later than [***] after the Effective Date a [***] forecast (the “[***] Forecast”) of Lilly’s anticipated purchase requirements of EQW Product for the Territory outside the U.S.; provided, however, that while the [***] of the [***] Forecast shall be in [***], [***] of the forecast shall be for [***]. Thereafter, Lilly shall [***] provide to Amylin a [***] Forecast as part of the long-range planning process. The Parties agree that each [***] Forecast will be used for planning purposes only and will not be binding on either Party.

 

(b)                                 Rolling Production Forecasts. The Parties, through the SCWT, will work together to develop forecasts, inventory targets, and production capacity requirements for Manufacture of EQW Product and submit the same to the Amylin Supply Operations. No later than [***] prior to the commencement of each [***] following the Effective Date, the Lilly SCWT leader or designee will provide to the Amylin SCWT leader or designee an estimate of the total quantity of EQW Product required to be delivered for the following [***] and the succeeding [***] (the “Forecast”). The Parties agree that the Forecast will be for general planning purposes only and will not be binding on either Party. Amylin will maintain a level of inventory of materials and components for the Manufacture of EQW Product as agreed upon by the SCWT.

 

***Confidential Treatment Requested

 

19


 

5.2                               Safety Stock.  The SCWT shall mutually agree upon the appropriate levels of safety stock of EQW Product and Components (as applicable) to be maintained by each Party for its respective territory. After the Effective Date, the SCWT shall review safety stock targets of EQW Product, Components, and other critical raw materials to be used in the Manufacture of EQW Product on at least [***] and review performance against such targets on at least [***].

 

5.3                               Limitations of Supply.  Amylin will use its Commercially Reasonable Efforts to make available at least [***] of the Forecast.  If at any time Amylin anticipates that it will be unable to supply in whole or in part the quantities of EQW Product set forth in a Lilly purchase order for any reason, including without limitation, Force Majeure, Amylin will inform Lilly as soon as possible via email of such anticipated shortfall.  Amylin will also notify Lilly of the underlying reason for the shortfall, proposed remedial measures, the date such inability to supply the full order of EQW Product is expected to end, and a proposed amount of EQW Product to be delivered to Lilly.  In the event fewer units of EQW Product are available than the Parties desire to purchase, the Parties will allocate available EQW Product on a pro rata basis based upon the Forecasts included in the most recent annual business plan approved by unanimous vote of the ASC; provided, however, that if a Party believes that a pro rata allocation based upon such Forecasts is not the appropriate allocation method, such Party may request that the Parties meet to discuss the issue, and the other Party shall agree to meet and consider in good faith the reasonable comments of the other Party.  If after such meeting, the Parties are unable to decide on the appropriate method for allocation, then the matter shall be resolved in accordance with Section 3.1(e)(ii) of the Collaboration Agreement.

 

(a)           Limitations of API.  In the event of a limitation of supply of API, Amylin agrees that it shall not adversely impact the supply of EQW Product to Lilly by unreasonably allocating such limited API disproportionately to any other exenatide-containing product.

 

(b)           Limitations of Components.  In the event of a limitation of supply of any Components, Amylin will inform Lilly as soon as possible via email of such anticipated shortfall.  Amylin will also notify Lilly of the underlying reason for the shortfall, proposed remedial measures, the date such inability to supply the Component is expected to end, and the proposed amount of the Component to be delivered to Lilly. In the event fewer units of the Component are available than the Parties desire to purchase, the Parties will allocate available Component on a pro rata basis based upon the Forecasts included in the most recent annual business plan approved by unanimous vote of the ASC;

 

***Confidential Treatment Requested

 

20



 

provided, however, that if a Party believes that a pro rata allocation based upon such Forecasts is not the appropriate allocation method, such Party may request that the Parties meet to discuss the issue, and the other Party shall agree to meet and consider in good faith the reasonable comments of the other Party.  If after such meeting, the Parties are unable to decide on the appropriate method for allocation, then the matter shall be resolved in accordance with Section 3.1(e)(ii) of the Collaboration Agreement.

 

5.4                               Purchase Orders.  Lilly will purchase EQW Product solely by submitting to Amylin written purchase orders (“Purchase Orders”).  Purchase Orders will be submitted by Lilly within [***] after the beginning of each [***] using the Standard Cost.  The SCWT will establish a reasonable minimum order size for EQW Product prior to submission of the first Forecast, and Lilly shall not submit Purchase Orders for less than such minimum order size unless otherwise agreed by the Parties.  The terms and conditions of this Agreement will be controlling over any terms and conditions in any such purchase orders, Amylin’s acknowledgement forms, or any other forms.  Upon submission to Amylin in accordance with this Section 5.4, a Purchase Order shall be deemed accepted by Amylin except to the extent it exceeds [***]% of the most recent applicable Forecast; provided however, that acceptance of a Purchase Order shall not guarantee that Amylin will have supply sufficient to fill such Purchase Order at the time such Purchase Order is submitted, it being agreed that Amylin shall fill such Purchase Order as soon as sufficient supply is available.  Lilly will submit each such Purchase Order to Amylin at least [***] in advance of the date specified in each Purchase Order by which delivery of the EQW Product is required.  Notwithstanding the foregoing, Amylin will use Commercially Reasonable Efforts, but will not be obligated, to meet any request of Lilly for delivery of EQW Product in less than [***], and further, Amylin will attempt, but will not be obligated, to accommodate any changes requested by Lilly in delivery schedules for EQW Product following Amylin’s receipt of Purchase Orders from Lilly in accordance with this Section 5.4.  Amylin will notify Lilly in writing of its acceptance or rejection of a specific purchase order within [***] of receipt thereof (e-mail notification is acceptable).  Amylin shall not have the right to reject a Purchase Order submitted to Amylin in accordance with this Section 5.4, except to the extent it exceeds the most recent applicable Forecast by more than [***]%; provided however, that acceptance of a Purchase Order shall not guarantee that Amylin will have supply sufficient to fill such Purchase Order at the time such Purchase Order is submitted, it being agreed that Amylin shall fill such Purchase Order as soon as sufficient supply is available.  Upon receipt and acceptance of each Purchase Order by Amylin hereunder, Amylin will use Commercially Reasonable Efforts to supply the EQW Product in such quantities on the delivery dates specified in such Purchase Order, unless otherwise mutually agreed to in writing by the Parties, except to

 

***Confidential Treatment Requested

 

21



 

the extent such purchase order exceeds the applicable Forecast by more than [***]%.  Purchase Orders accepted by Amylin may not be cancelled except by mutual agreement of the Parties.

 

5.5                               Title Transfer; Shipment of EQW Product.  Shipment of EQW Product ordered by Lilly will be to one or more distribution service providers designated by Lilly.  Amylin will not make direct shipments to final customers in the Territory outside the U.S.  Lilly will select and pay the carrier to be used.  EQW Product will be shipped FCA (Amylin Facility) Incoterms 2000 or as may otherwise be required pursuant to Applicable Laws.  Title and risk of loss or damage to the EQW Product will remain with Amylin until the EQW Product is delivered to the carrier, at which time title to EQW Product will rest in, and risk of loss or damage to EQW Product will pass to Lilly.  Lilly will cause EQW Product to be picked up at the Facility dock no later than [***] after the later of (i) the delivery date specified in the applicable Purchase Order, and (ii) the date Amylin makes such EQW Product available for shipment.  Any discrepancies between quantity shipped from Amylin and quantity arriving at Lilly will be jointly investigated.

 

5.6.                          Use of a Single Lot in both US and OUS.  EQW Product from a single production batch or lot shall not be made available for use by Amylin inside the U.S. and by Lilly outside the U.S without the prior written consent of Amylin.  No later than [***] prior to the planned date of the first application for marketing approval to a Regulatory Authority other than the FDA, the Parties agree to discuss in good faith whether EQW Product from a single production batch or lot shall be used both in the U.S. and outside the U.S.  If the Parties agree that such split uses are appropriate, then the Parties agree to work towards a procedure that will describe how EQW Product from a single production batch or lot shall be made available for use by Amylin inside the U.S. and by Lilly outside the U.S.  If the Parties are not able to agree that such split uses are appropriate or are unable to agree upon such a procedure, then Lilly shall be responsible for the first $[***] of losses per [***] arising from any inventory rendered obsolete solely due to the fact that a single production batch or lot was not available for use by Amylin inside the U.S. and by Lilly outside the U.S.  The remainder of any such losses shall be allocated in accordance with the last sentence of Section 5.9.

 

5.7.                            Taxes.  Lilly acknowledges it is responsible for any Value Added Tax and sales taxes related to the purchase of EQW Product.

 

***Confidential Treatment Requested

 

22



 

5.8                               Inspection; Rejection.

 

(a)           Lilly shall be allowed a maximum of [***] days from the date of receipt of any shipment for inspection and provision of written notice to Amylin of rejection of any portion or all of that shipment (“Inspection Period”).  If Lilly does not deliver such written notice to Amylin within such Inspection Period, Lilly shall be deemed to have accepted the shipment, except in the case of Latent Defects.

 

(b)           Promptly following notice of rejection, Amylin and Lilly shall mutually determine whether the rejected shipment conformed to the Specifications and warranties and, if the rejected shipment did not so conform, in what ways the rejected shipment did not so conform.  If the Parties cannot agree upon such issue by the end of the Inspection Period, then the Head of Quality (or any successor position) of Amylin and the Head of Quality  (or any successor position) of Lilly shall mutually determine in good faith whether the rejected shipment conformed to the Specifications and warranties, using such further testing procedures as such individuals may agree, including, if such individuals so determine, submitting the rejected items and Specifications to a mutually acceptable, independent laboratory for determination of whether such items conformed to the Specifications and warranties.  Lilly shall provide to Amylin samples of rejected EQW Product, as Amylin shall reasonably request for the purpose of performing additional testing pursuant to this Section 5.8.  The non-prevailing Party shall bear all reasonable cost of such independent laboratory assessment.

 

(c)           If it is determined that the rejected EQW Product was non-conforming, then Amylin shall replace such EQW Product as promptly as practicable.  The Actual Manufacturing Cost of the rejected EQW Product, the Actual Manufacturing Cost of the replacement EQW Product and Lilly’s cost of return or disposal of rejected, non-conforming EQW Product shall be included in Cost of Product Sold for purposes of Article 4 of the Collaboration Agreement, unless and to the extent that such costs are a result of Amylin’s gross negligence or willful misconduct, in which event Amylin shall pay or reimburse such costs to Lilly in full.  Rejected or non-conforming EQW Product shall be returned to Amylin or disposed of, as directed by Amylin.

 

5.9                               Inventory Obsolescence.   With respect to EQW Product and Components, Lilly will be responsible for the inventory loss for lots intended for sale in the Territory outside the U.S., based on  purchase orders submitted [***] in advance and accepted by Amylin under Section 5.4, that are delivered to Lilly with the product dating agreed upon by the SCWT.  Inventory obsolescence related to all other EQW Product and Components will be shared by the Parties on a pro rata basis based on the forecasts included in the most

 

***Confidential Treatment Requested

 

23



 

recent [***] business plan approved by the ASC, with Lilly and Amylin equally sharing the U.S. allocation and Lilly solely responsible for the OUS allocation.

 

ARTICLE 6

TRADE DRESS AND PACKAGING

 

6.1                               Trade Dress and Packaging.  Amylin will ensure that the EQW Product that is delivered to Lilly hereunder is prepared and packed for shipment in compliance with applicable Marketing Approvals and cGMP, and in accordance with the MRD/Quality Agreement.  All trade dress and packaging for EQW Product, including use of EQW Product Trademarks, Amylin Marks and Lilly Marks shall be consistent with the requirements of Section 9.5 of the Collaboration Agreement.

 

6.2                               Lot Numbering.  Amylin’s lot numbers will be affixed on the containers for the EQW Product and on each shipping carton in accordance with Applicable Laws.

 

6.3                               Release Testing.  The QLT will establish procedures for release testing EQW Product Manufactured for Lilly to ensure that EQW Product conforms to Applicable Laws.

 

ARTICLE 7

REGULATORY AND RECALL

 

7.1  Regulatory Responsibility.  All matters related to the Parties’ regulatory responsibilities, including, without limitation, recall of EQW Product, regulatory communications, cooperation between the Parties, quality assurance and manufacturing audits, will be as set forth in this Agreement, the Quality Agreement and the Collaboration Agreement.  The QLT will also coordinate contacts with Regulatory Authorities with respect to the EQW Product, it being anticipated that each Party shall have the right to participate in key regulatory decisions and meetings.  If any Regulatory Authority requires the Regulatory Lead to have the ability to institute recalls unilaterally in a particular Regulatory Jurisdiction, then the Regulatory Lead shall have such right.  All costs of recall incurred by the Parties in accordance herewith will be shared by the Parties in proportion to their respective shares, at the time of the recall, of U.S. EQW Gross Profit and OUS EQW Gross Profit under the Collaboration Agreement, as amended, except to the extent due to a Party’s gross negligence or willful misconduct, in which case that Party will be solely responsible for such costs of recall

 

***Confidential Treatment Requested

 

24



 

ARTICLE 8

INTELLECTUAL PROPERTY

 

Pursuant to the Collaboration Agreement, the Parties have each granted to the other all licenses to patents, know-how or other intellectual property necessary for the performance of the Parties’ obligations under the Collaboration Agreement.  Any inventions resulting from the activities contemplated by this Agreement shall also be governed by the provisions of the Collaboration Agreement, except to the extent Amylin’s rights to license certain intellectual property may be limited by its Development and License Agreement with Alkermes Controlled Therapeutics Inc. II, dated May 15, 2000, as amended.

 

ARTICLE 9
REPRESENTATIONS AND WARRANTIES OF LILLY

 

Lilly hereby represents and warrants to Amylin that, as of the Effective Date hereof:

 

9.1                               Organization and Standing. Lilly is a corporation duly organized, validly existing and in good standing under the laws of the State of Indiana.

 

9.2                               Power and Authority. Lilly has all requisite corporate power and authority to execute, deliver, and perform this Agreement and to consummate the transactions contemplated herein.  The execution, delivery, and performance of this Agreement by Lilly does not, and the consummation of the transactions contemplated hereby will not, violate any provisions of Lilly’s organizational documents, bylaws, or any Applicable Law applicable to Lilly, or any material agreement, mortgage, lease, instrument, order, judgment, or decree to which Lilly is a party or by which Lilly is bound.

 

9.3                               Corporate Action; Binding Effect. Subject to Section 16.17, below, Lilly has duly and properly taken all action required by law, its organizational documents, or otherwise, to authorize the execution, delivery, and performance of this Agreement and the other instruments to be executed and delivered by it pursuant hereto and the consummation of the transactions contemplated hereby and thereby.  Subject to Section 16.17, below, this Agreement has been duly executed and delivered by Lilly and constitutes, and the other instruments contemplated hereby when duly executed and delivered by Lilly will constitute, legal, valid, and binding obligations of Lilly enforceable against it in accordance with its respective terms, except as enforcement may be affected by bankruptcy, insolvency, or other similar laws.

 

25



 

9.4                               Governmental Approval.  Except as contemplated by this Agreement, no consent, approval, waiver, order or authorization of, or registration, declaration or filing with, any Regulatory Authority or any other Third Person is required in connection with the execution, delivery and performance of this Agreement, or any agreement or instrument contemplated by this Agreement, by Lilly or the performance by Lilly of its obligations contemplated hereby and thereby.

 

9.5                               Brokerage.  No broker, finder or similar agent has been employed by or on behalf of Lilly, and no Person with which Lilly has had any dealings or communications of any kind is entitled to any brokerage commission, finder’s fee or any similar compensation, in connection with this Agreement or the transactions contemplated hereby.

 

9.6                               Litigation.  There are no pending or, to Lilly’s knowledge, threatened judicial, administrative or arbitral actions, claims, suits or proceedings pending as of the date hereof against Lilly relating to the subject matter of this Agreement, which, either individually or together with any other, will have a material adverse effect on the ability of Lilly to perform its obligations under this Agreement or any agreement or instrument contemplated hereby.

 

9.7                               Not Debarred.  Lilly is not debarred and has not and will not use in any capacity the services of any Person debarred under subsections 306(a) or (b) of the Generic Drug Enforcement Act of 1992.  If at any time this representation and warranty is no longer accurate, Lilly will notify Amylin of such fact.

 

9.8                               Applicable Laws.  Lilly will comply with Applicable Laws relating to its distributing, marketing, promoting and selling of the EQW Product.

 

9.9                               Implied Warranties.  EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE 9, LILLY MAKES NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND LILLY SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED OR STATUTORY WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE AND WARRANTY OF NONINFRINGEMENT.

 

26


 

ARTICLE 10
REPRESENTATIONS AND WARRANTIES OF AMYLIN

 

Amylin represents and warrants to Lilly that, as of the Effective Date hereof:

 

10.1                        Organization and Standing. Amylin is a company duly organized, validly existing, and in good standing under the laws of Delaware.

 

10.2                        Power and Authority. Amylin has all requisite corporate power and authority to execute, deliver, and perform this Agreement and to consummate the transactions contemplated herein.  The execution, delivery, and performance of this Agreement by Amylin does not, and the consummation of the transactions contemplated hereby will not, violate any provisions of Amylin’s organizational documents, bylaws, or any Applicable Laws applicable to Amylin, or any material agreement, mortgage, lease, instrument, order, judgment, or decree to which Amylin is a party or by which Amylin is bound.

 

10.3                        Corporate Action; Binding Effect. Amylin has duly and properly taken all action required by law, its organizational documents, or otherwise, to authorize the execution, delivery, and performance of this Agreement and the other instruments to be executed and delivered by it pursuant hereto and the consummation of the transactions contemplated hereby and thereby.  This Agreement has been duly executed and delivered by Amylin and constitutes, and the other instruments contemplated hereby when duly executed and delivered by Amylin will constitute, legal, valid, and binding obligations of Amylin enforceable against it in accordance with its respective terms, except as enforcement may be affected by bankruptcy, insolvency, or other similar laws.

 

10.4                        Governmental Approval.  Except as contemplated by this Agreement, no consent, approval, waiver, order or authorization of, or registration, declaration or filing with, any Regulatory Authority or any other Third Person is required in connection with the execution, delivery and performance of this Agreement, or any agreement or instrument contemplated by this Agreement, by Amylin or the performance by Amylin of its obligations contemplated hereby and thereby.

 

10.5                        Brokerage.  No broker, finder or similar agent has been employed by or on behalf of Amylin, and no Person with which Amylin has had any dealings or communications of any kind is entitled to any brokerage commission, finder’s fee or any similar compensation, in connection with this Agreement or the transactions contemplated hereby.

 

27



 

10.6                        Litigation.  There are no pending or, to Amylin’s knowledge, threatened judicial, administrative or arbitral actions, claims, suits or proceedings pending as of the date hereof against Amylin relating to the subject matter of this Agreement, which, either individually or together with any other, will have a material adverse effect on the ability of Amylin to perform its obligations under this Agreement or any agreement or instrument contemplated hereby.

 

10.7                        Not Debarred. Amylin is not debarred and has not and will not use in any capacity the services of any Person debarred under subsections 306(a) or (b) of the Generic Drug Enforcement Act of 1992.  If at any time this representation and warranty is no longer accurate, Amylin will immediately notify Lilly of such fact.

 

10.8                        EQW Product Specifications.  Amylin will ensure that as of the date of delivery, EQW Product delivered by Amylin to Lilly hereunder: (i) will conform to the Specifications in effect at the time of manufacture, (ii) will have been Manufactured in accordance with cGMP and cQSR, as applicable, in effect at the time of manufacture, (iii) will not be adulterated or misbranded by Amylin within the meaning of the FD&C Act, and (iv) will not have been knowingly manufactured or sold in violation of any Applicable Laws of the U.S in any material respect (collectively “EQW Product Warranty”).  Upon delivery to Lilly, FCA (Amylin’s Facility) Incoterms 2000, Amylin will convey good title to the EQW Product to Lilly as of the date of shipment, free and clear of any lien or encumbrance.

 

10.9                        Applicable Laws.  Amylin will comply with Applicable Laws relating to its supply of the EQW Product.

 

10.10                 Implied Warranties.  EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE 10, AMYLIN MAKES NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND AMYLIN SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED OR STATUTORY WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE AND WARRANTY OF NONINFRINGEMENT.

 

ARTICLE 11
TERM OF AGREEMENT; TERMINATION

 

11.1                        Term of Agreement.  Unless earlier terminated in accordance with this Article 11, this Agreement will take effect and commence on the Effective Date and will expire at such

 

28



 

time as the Collaboration Agreement expires.  In the event of termination of the Collaboration Agreement prior to its expiration, this Agreement shall continue in effect unless terminated at the option of either Party as provided in Section 11.2(c) below.  This Agreement may also be terminated by mutual agreement of the Parties.

 

11.2                        Termination for Cause.  In addition to the Parties’ right to terminate by mutual agreement under Section 11.1 above, this Agreement may be terminated as follows:

 

(a)           A Party may terminate this Agreement immediately by providing written notice to the other Party if the other Party is declared insolvent or bankrupt by a court of competent jurisdiction, or a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by the other Party or an involuntary petition for relief under the United States Bankruptcy Code is filed in a court of competent jurisdiction against the other Party which is not dismissed within thirty (30) days of its filing, or the other Party makes or executes any assignment for the benefit of creditors.

 

(b)           Either Party may terminate this Agreement in the event of a material breach of this Agreement by the other; provided that if the breaching Party cures such material breach within the cure period provided in Section 11.3, then the other Party will be obligated to continue to perform its obligations under this Agreement, and this Agreement will continue in full force and effect.

 

(c)           Either Party may terminate this Agreement immediately in the event the Collaboration Agreement is terminated for any reason.

 

11.3                        Procedures for Termination for Material Breach.  A termination of this Agreement pursuant to Section 11.2(b) shall not be effective unless the terminating Party complies with the following procedures:

 

The terminating Party will give the other Party prior written notice thereof, specifying in reasonable detail the alleged material breach, and if such alleged material breach or material default continues unremedied for a period of thirty (30) days after the date of receipt of the notification or, if the material breach reasonably cannot be corrected or remedied within thirty (30) days, then if (i) the defaulting Party has not commenced remedying said material breach within said thirty (30) days and is not diligently pursuing completion of same, or (ii) said material breach or material default has not been corrected or remedied within one-hundred twenty (120) days, then such terminating Party may immediately terminate this Agreement by again providing written notification to the defaulting Party and such termination shall be effective as of the date that such notice was

 

29



 

delivered to the other Party.  This Section 11.3 will not be exclusive and will not be in lieu of any other remedies available to a Party hereto for any breach or default hereunder on the part of the other Party.

 

11.4                        Effect of Termination.

 

(a)           Upon termination of this Agreement for any reason (whether due to breach of either Party or otherwise), Amylin will furnish to Lilly a complete written inventory of all work in progress and an inventory of all finished EQW Product.  Unless otherwise agreed to between the Parties, all stock on hand as of the effective date of any termination of this Agreement will be dealt with promptly as follows:

 

1.              EQW Product Manufactured and packaged pursuant to Purchase Orders from Lilly and accepted by Amylin will be delivered by Amylin to Lilly, whereupon Lilly will pay Amylin therefore in accordance with the terms hereof.

 

2.              Work in progress commenced by Amylin against accepted Purchase Orders from Lilly will be completed by Amylin and delivered to Lilly, whereupon Lilly will pay Amylin therefore in accordance with the terms hereof.

 

(b)           In the event of termination of this Agreement by Amylin for Lilly’s material breach or termination of this Agreement in the event of termination of the Collaboration Agreement by Amylin for Lilly’s material breach, Lilly shall be solely responsible for any wind down costs incurred by the Parties that cannot be reasonably avoided.  In the event of termination of this Agreement by Lilly for Amylin’s material breach or termination of this Agreement in the event of termination of the Collaboration Agreement by Lilly for Amylin’s material breach, Amylin shall be solely responsible for any wind down costs incurred by the Parties that cannot be reasonably avoided.  In the event of termination of this Agreement by mutual agreement of the Parties or for any other reason, including Force Majeure,  the Parties shall share in any wind down costs incurred by the Parties that cannot be reasonably avoided as follows:  Lilly shall be responsible for an amount equal to either (i) in the event termination occurs prior to the True-Up Date (as defined in Exhibit E) [***]% or (ii) in the event the termination occurs after the True-Up Date, the Lilly Percentage (as defined in Exhibit E) and Amylin shall be

 

***Confidential Treatment Requested

 

30



 

responsible for the balance.  Wind down costs shall include, without limitation, commitments to Third Party Suppliers that cannot be reasonably avoided.

 

(c)           With respect to any EQW Product-specific capital investments incurred as part of EQW Product Manufacturing made by either Party that have a remaining undepreciated amount at the time Amylin ceases to Manufacture EQW Product in accordance with this Article 11:

 

1.               if the Collaboration Agreement is in effect immediately following termination of this Agreement, then: (i) in the event of termination of this Agreement by Lilly for Amylin’s breach, Amylin will be solely responsible for such undepreciated amounts, regardless of whether such capital investments are usable by Amylin; and (ii) in the event of termination of this Agreement by Amylin for Lilly’s breach, Lilly will be solely responsible for such undepreciated amounts for capital investments that are not readily usable by Amylin less salvage value, and Amylin will be solely responsible for such undepreciated amounts for capital investments that are readily usable by Amylin; and (iii) in the event of termination of this Agreement other than for breach by a Party,  the parties shall share such undepreciated amounts as follows:  Lilly shall be responsible for an amount equal to either (i) in the event termination occurs prior to the True-Up Date (as defined in Exhibit E), [***] ([***]%.), or (ii) in the event termination occurs after the True-Up Date, the Lilly Percentage (as defined in Exhibit E) less (a) such portion of the financing charge for the Initial Capital Investment that has not yet been amortized in accordance with Exhibit G, (b) any amount due to Lilly under the Loan Agreement, plus any and all outstanding interest thereon, (c) any other amounts due and payable to Lilly from Amylin at the time of termination; and (d) any amounts for any assets that can otherwise be utilized for other uses by Amylin; plus any other amounts due and payable to Amylin from Lilly at the time of termination.

 

***Confidential Treatment Requested

 

31



 

2.               if this Agreement expires in accordance with Section 11.1 or is terminated pursuant to Section 11.2(c) of this Agreement as a result of termination of the Collaboration Agreement, then: (i) in the event of termination of the Collaboration Agreement by Lilly pursuant to Section 12.3 thereof or expiration of this Agreement in accordance with Section 11.1 hereof, the Parties shall share such undepreciated amounts as follows:  Lilly shall be responsible for an amount equal to either (i) in the event termination occurs prior to the True-Up Date (as defined in Exhibit E), [***] percent ([***]%.), or (ii) in the event termination occurs after the True-Up Date, the Lilly Percentage (as defined in Exhibit E) less (a) such portion of the financing charge for the Initial Capital Investment that has not yet been amortized in accordance with Exhibit G, (b) any amount due to Lilly under the Loan Agreement, plus any and all outstanding interest thereon, (c) any other amounts due and payable to Lilly from Amylin at the time of the termination; and (d) any amounts for any assets that can otherwise be utilized for other uses by Amylin; plus any other amounts due and payable to Amylin from Lilly at the time of termination; (iii) in the event of termination of the Collaboration Agreement by Lilly for Amylin’s breach, Amylin will be solely responsible for such undepreciated amounts; and (iv) in the event of termination of the Collaboration Agreement by Amylin for Lilly’s breach, Lilly will be solely responsible for such undepreciated amounts which are not readily usable by Amylin, less salvage value.

 

(d)           To the extent that a Party is responsible for all or any portion of undepreciated amounts for a capital investment made by the other Party as described above, such Party shall reimburse the other Party for its share of such undepreciated amounts within an agreed-upon number of days, but in no event longer than ninety (90) days, after the date on which Amylin ceases to Manufacture EQW Product in accordance with this Article 11; provided, however the Parties agree to apply appropriate offsets as described in Section 3.10 hereof. 

 

***Confidential Treatment Requested

 

32



 

(e)           In addition, upon expiration of this Agreement or termination of this Agreement for any reason (whether due to breach of this Agreement by either Party, Force Majeure, or otherwise), in the event Lilly has the right to, and intends to continue to commercialize EQW Product:

 

1.               Promptly following termination of this Agreement, and as soon as practicable given Amylin’s continuing obligation to supply EQW Product until the transfer described in this Section 11.4(e) is complete, to the extent permissible under its agreements with Alkermes, Amylin will transfer to a Third Party manufacturer designated by Lilly and approved by Amylin, such approval not to be unreasonably withheld or delayed (the “Successor Manufacturer”), such Amylin Rights, Amylin Information, manufacturing records and EQW Product-specific equipment and test or control procedures with respect to the Manufacture of EQW Product as is reasonably necessary to permit the Successor Manufacturer to Manufacture EQW Product meeting the Specifications on behalf of the Parties or Lilly, and will provide Lilly with a copy (or access to) such Amylin Rights, Lilly Amylin Information, manufacturing records, equipment and test or control procedures for use by the Successor Manufacturer and Lilly solely in relation to Manufacture of EQW Product.  The Parties shall provide the Successor Manufacturer with commercially reasonable technical and other assistance in connection with the use of such Amylin Rights and Amylin Information for the Manufacture of EQW Product and with the scale-up and validation to applicable regulatory standards of the Successor Manufacturer for the Manufacture of EQW Product in accordance with the Specifications.  Each Party shall use its Commercially Reasonable Efforts to enable the Successor Manufacturer to Manufacture EQW Product in accordance with the Specifications on a commercial scale sufficient to fulfill reasonable anticipated sales of EQW Product as soon as reasonably practicable.  At Lilly’s request,

 

33



 

Amylin will introduce Lilly and the Successor Manufacturer to Amylin’s vendors of raw materials or components used in the Manufacture of EQW Product, and will provide reasonable assistance to Lilly and/or the Successor Manufacturer, as applicable, in its efforts to enter into supply relationships with such vendors.  If any such vendor supplies Amylin with any such raw materials or components on an exclusive basis, Amylin shall waive compliance with any such condition to allow such vendor to transact business with Lilly and/or the Successor Manufacturer, as applicable solely in relation to the Manufacture of EQW Product;

 

2.               The costs and expenses incurred by Amylin in effecting the technology transfer and providing the assistance described in Section 11.4(e)(1) (collectively, the “Technology Transfer”) will be borne solely by Amylin in the event of (i) termination of this Agreement by Lilly for Amylin’s breach, or (ii) termination of this Agreement by either Party in the event of termination of the Collaboration Agreement either by Lilly for Amylin’s breach thereof or by Amylin pursuant to Section 12.3 thereof.  In the event of termination of this Agreement by Amylin for Lilly’s breach, or voluntary termination of this Agreement by Lilly pursuant to Section 11.2 of this Agreement, or termination of this Agreement by either Party in the event of termination of the Collaboration Agreement by Amylin for Lilly’s breach thereof, Lilly will reimburse Amylin in full for Amylin’s reasonable and documented costs and expenses of performing the Technology Transfer within thirty (30) days of invoice by Amylin (such invoices to be delivered monthly).

 

11.5                        Supply Following Termination.  In the event this Agreement is terminated for any reason other than termination of this Agreement by Amylin pursuant to Section 11.2(b), Amylin shall, if Lilly so requests in writing, continue to use its Commercially Reasonable Efforts to supply EQW Product to Lilly pursuant to this Agreement until such time as the Successor Manufacturer is able to Manufacture EQW Product on a commercial scale

 

34



 

sufficient to fulfill reasonable anticipated sales of EQW Product and obtain or maintain required Marketing Approvals, except that in the case of termination of this Agreement by either Party pursuant to Section 11.2(c) hereof Amylin shall supply EQW Product to Lilly for no longer than thirty-six  (36) months from termination of this Agreement. Amylin will supply such EQW Product to Lilly, and Lilly shall obtain such EQW Product from Amylin, in accordance with the terms and conditions of this Agreement.

 

11.6                        Continuing Obligations.  Termination of this Agreement for any reason will not relieve the Parties of any obligation accruing prior thereto or any antecedent breach of the provisions of this Agreement, and will be without prejudice to the rights and remedies of either Party with respect to any antecedent breach of the provisions of this Agreement.  Without limiting the generality of the foregoing and in addition to the foregoing, no termination of this Agreement, whether by lapse of time or otherwise, will serve to terminate the rights and obligations of the Parties hereto under Articles 1, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16, and Sections 3.5, 3.9, 3.10, 3.11, 4.3, 4.6, 4.8 and 5.9, or rights and obligations which otherwise expressly survive the termination of this Agreement and Sections which are necessary to give effect to rights and obligations which expressly survive the expiration or termination of this Agreement.

 

11.7                        Non-Exclusive Remedies.  The remedies set forth in this Article 11 or elsewhere in this Agreement will be in addition to, and will not be to the exclusion of, any other remedies available to the Parties at law, in equity or under this Agreement.

 

11.8                        Mitigation of Damages.  In the event of any breach of this Agreement by Amylin or Lilly, the other Party shall take reasonable actions to mitigate its damages.

 

ARTICLE 12

DISPUTE RESOLUTION

 

Disputes between the Parties concerning either Party’s rights or obligations under this Agreement shall be resolved as set forth in the Collaboration Agreement.

 

35



 

ARTICLE 13
CONFIDENTIALITY

 

Confidentiality, nondisclosure and nonuse of information and publication relating to the activities contemplated by this Agreement shall be governed by the provisions of the Collaboration Agreement.

 

ARTICLE 14
ADDITIONAL COVENANTS AND AGREEMENTS OF THE PARTIES

 

14.1                        Compliance with Law.  Each of the Parties will comply with all Applicable Laws relating to its obligation hereunder.

 

14.2                        Commercially Reasonable Efforts.  Except as otherwise provided in this Agreement or the Collaboration Agreement, Lilly and Amylin each hereby agree to use all Commercially Reasonable Efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things reasonably necessary or proper to make effective the transactions contemplated by this Agreement, including such actions as may be reasonably necessary to obtain approvals and consents of any Regulatory Authority and other Persons; provided, however, that no Party will be required to (i) pay money (other than as expressly required pursuant to this Agreement or the Collaboration Agreement or as implicitly required in order for a  Party to carry out its obligations hereunder), or (ii) assume any other material obligation not otherwise required to be assumed by this Agreement or the Collaboration Agreement.

 

14.3                        Further Assurances.  The Parties intend that this Agreement contain all consents, licenses and authorizations from one Party to the other necessary to enable each Party to perform its obligations hereunder.  In the event any further such consents, licenses or authorizations are necessary, each Party agrees to take such further actions and execute such further agreements as may be reasonably necessary to carry out the intent and purposes of this Agreement.

 

ARTICLE 15
INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE

 

15.1                        Indemnification.  Indemnification obligations of the Parties will be provided as set forth in the Collaboration Agreement.

 

36


 

15.2                        Limitation of Liability. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, IN NO EVENT WILL EITHER PARTY BE LIABLE FOR INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL (INCLUDING LOST PROFITS) OR PUNITIVE DAMAGES, HOWEVER CAUSED OR UPON ANY THEORY OF LIABILITY (INCLUDING A PARTY’S OWN NEGLIGENCE, GROSS NEGLIGENCE OR WILLFUL MISCONDUCT (OR THE NEGLIGENCE, GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF A PARTY’S EMPLOYEES, AGENTS CONTRACTORS OR SUBCONTRACTORS)). NOTHING IN THIS SECTION IS INTENDED TO LIMIT OR RESTRICT INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER THE INDEMNIFICATION PROVISIONS OF THIS AGREEMENT.

 

15.3                        Insurance. The Parties will each, throughout the Term of this Agreement, maintain at its own cost and expense from a qualified insurance company, comprehensive general liability insurance and product liability insurance in an amount that is customary in the pharmaceutical and device industries.

 

ARTICLE 16
MISCELLANEOUS PROVISIONS

 

16.1                        Successors and Assigns. This Agreement will be binding upon and will inure to the benefit of the Parties hereto and their respective successors and assigns. This Agreement may not be assigned or otherwise transferred, nor, except as expressly provided hereunder, may any right or obligation hereunder be assigned or transferred by either Party without the prior written consent of the other Party; provided, however, that either Party may, without such consent, assign the Agreement and its rights and obligations hereunder to an Affiliate or in connection with the transfer or sale of all or substantially all of its assets or business to which this Agreement relates, or in the event of its merger or consolidation or change in control or similar transaction. In the event of such transaction, however, intellectual property rights of the acquiring party to such transaction (if other than one of the Parties to this Agreement) shall not be included in any technology licensed hereunder. The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties. Any attempted assignment not in accordance with this Section 16.1 will be void.

 

37



 

16.2                        Notices. Unless otherwise stated in this Agreement as to the method of delivery, all notices or other communications required or permitted to be given hereunder will be as set forth in Section 14.6 of the Collaboration Agreement.

 

16.3                        Waiver. Any term or provision of this Agreement may be waived at any time by the Party entitled to the benefit thereof only by a written instrument executed by such Party. Except as otherwise provided in this Agreement no delay on the part of Lilly or Amylin in exercising any right, power or privilege hereunder will operate as a waiver thereof, nor will any waiver on the part of either Lilly or Amylin of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege hereunder nor will any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder

 

16.4                        Entire Agreement. This Agreement, the Collaboration Agreement and Related Agreements, each of their appendices, exhibits, schedules and certificates, and all documents and certificates delivered or contemplated in connection herewith and therewith constitute the entire agreement between the Parties with respect to the subject matter hereof and supersede all prior agreements or understandings of the Parties relating thereto.

 

16.5                        Amendment. This Agreement may be modified or amended only by written agreement of the Parties hereto signed by authorized representatives of the Parties.

 

16.6                        Counterparts. This Agreement may be executed in any number of counterparts, each of which will be deemed an original but all of which together will constitute a single instrument.

 

16.7                        Governing Law. This Agreement will be governed and construed in accordance with the laws of the State of New York excluding any choice of law rules that may direct the application of the law of another state.

 

16.8                        Headings. All section titles or headings contained in this Agreement and in any exhibit, schedule or certificate referred to herein or attached to this Agreement are for convenience only, will not be deemed a part of this Agreement and will not affect the meaning or interpretation of this Agreement.

 

16.9                        No Third Person Rights. No provision of this Agreement will be deemed or construed in any way to result in the creation of any rights or obligations in any Person not a Party to this Agreement.

 

38



 

16.10                 Construction. This Agreement will be deemed to have been drafted by both Lilly and Amylin and will not be construed against either Party as the draftsperson hereof. Whenever this Agreement refers to a number of days, such number shall refer to calendar days unless business days are specified.

 

16.11                 Appendices, Exhibits, Schedules and Certificates. Each attachment and exhibit attached hereto is incorporated herein by reference and made a part of this Agreement.

 

16.12                 No Joint Venture. Nothing contained in this Agreement will be deemed to create any joint venture or partnership between the Parties hereto, and, except as is expressly set forth herein, neither Party will have any right by virtue of this Agreement to bind the other Party in any manner whatsoever.

 

16.13                 Severability. If any provision of this Agreement is held to be illegal, invalid, or unenforceable under present or future laws effective while this Agreement remains in effect, the legality, validity and enforceability of the remaining provisions will not be affected thereby. In the event a part or provision of this Agreement is held to be illegal, invalid or unenforceable, the Parties agree to negotiate in good faith an amendment of such part or provision in a manner consistent with the intention of the Parties.

 

16.14                 Force Majeure. If either Party is prevented from complying, either totally or in part, with any of the terms or provisions set forth herein by reason of an event of Force Majeure, including, by way of example and not of limitation, fire, flood, explosion, storm, strike, lockout or other labor dispute, riot, war, rebellion, accidents, terrorist acts, acts of God, acts of governmental agencies or instrumentalities, inability to obtain materials from suppliers, or any other similar or dissimilar cause, in each case to the extent beyond its reasonable control (“Force Majeure”), such Party will provide written notice of such event to the other Party. Said notice will be provided within five (5) business days of the occurrence of such event and will identify the requirements of this Agreement or such of its obligations as may be affected, and, to the extent so affected, said obligations will be suspended during the period of such disability. The Party prevented from performing hereunder will use Commercially Reasonably Efforts to remove such disability as promptly as possible and will continue performance whenever such causes are removed. The Party so affected will give to the other Party a good faith estimate of the continuing effect of the Force Majeure condition and the duration of the affected Party’s nonperformance. If the period of any previous actual nonperformance of a Party because of Force Majeure conditions plus the anticipated future period of such Party’s nonperformance because of such conditions will exceed an aggregate of one

 

39



 

hundred twenty (120) days within any one year period, the other Party may terminate this Agreement by prior written notice to the nonperforming Party.

 

16.15                 Fundamental Principle of Good Faith and Fair Dealing. In entering into this Agreement, Lilly and Amylin each acknowledge and agree that all aspects of the business relationship and dealings between Lilly and Amylin contemplated by this Agreement shall be governed by the fundamental principle of good faith and fair dealing.

 

16.16                 Interpretation. In the event of any conflict between this Agreement and the Collaboration Agreement, the terms of this Agreement shall control.

 

16.17                 Effective Date. This Agreement shall become effective upon the date approved by Lilly’s Board of Directors (the “Effective Date”). Lilly agrees to cause its management to recommend approval of this Agreement to its Board of Directors on or before October 20, 2008, and shall promptly notify Amylin of the Lilly Board decision regarding this Agreement.

 

[signature page to follow]

 

40



 

IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the date first above written.

 

 

 

ELI LILLY AND COMPANY

 

 

 

 

 

By:

/S/ JOHN C. LECHLEITER

 

Printed Name:

John C. Lechleiter

 

Title:

President and Chief Executive Officer

 

 

 

 

 

AMYLIN PHARMACEUTICALS, INC.

 

 

 

 

 

By:

/S/ MARK G. FOLETTA

 

Printed Name:

Mark G. Foletta

 

Title:

Senior Vice President, Finance and Chief Financial Officer

 

41



 

EXHIBIT A

 

DEFINITION OF ALLOCATION OF SERVICE FOR

ACTUAL MANUFACTURING COST CALCULATION

 

“Actual Manufacturing Cost” will include Amylin’s costs for allocation of service, in addition to other cost elements. Calculation of the Actual Manufacturing Cost will be consistent with the usual methodology utilized by Amylin to calculate Amylin’s Cost of Products Sold in accordance with U.S. GAAP.

 

Allocation of services is the cost of the indirect materials, indirect labor and all other expenses incurred in the support of production and for the acquisition of materials related to production of the EQW Product. The labor related charges included in the Allocation of Services would be calculated using the actual FTE Rate. To the extent the costs above are not directly traceable to production of the EQW Product, Amylin in good faith will apply reasonable allocation methods to such costs. Examples of items that are incorporated as part of the Allocation of Services include:

 

(1)         repair and maintenance;

(2)          on-going qualification/validation/in process testing/ stability testing and investigations;

(3)          manufacturing equipment and manufacturing support equipment calibration costs;

(4)          utilities;

(5)          depreciation and amortization;

(6)          material testing;

(7)          pre-inspection approval costs (including validation costs), which consists of Amylin’s internal labor and any out-of-pocket costs on an actual dollar for dollar basis;

(8)          Prorated costs for manufacturing administration such as complaint handling, customer service, technical stewardship, logistics, production planning, regulatory support, training and development, procedure coordination, procurement, finance and IT support, and

(9)          Other costs that are required to support the manufacture of EQW Product in accordance with U.S. GAAP

 

The costs of general corporate expenses that are not related to the Manufacture of EQW Product, are not included in the Allocation of Services.

 



 

EXHIBIT B

 

ESTIMATED TOTAL INITIAL CAPITAL INVESTMENT FOR EQW MANUFACTURING ($MM)

 

 

 

Estimated Total

 

 

 

Investment

 

Project: Stage I Ohio

 

 

 

[***]

 

$

[***]

 

[***]

 

 

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

 

 

 

 

TOTAL

 

$

[***]

 

 

 

 

 

Project: Stage II Ohio

 

 

 

[***]

 

 

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

 

 

 

 

TOTAL

 

$

[***]

 

 

 

 

 

Project: Westchester Site

 

 

 

[***]

 

$

[***]

 

 

 

 

 

TOTAL

 

$

[***]

 

 

 

 

 

SUBTOTAL - FACILITY CAPITAL

 

$

[***]

 

 

 

***Confidential Treatment Requested

 



 

EQW-Dedicated Capital Outside of Westchester

 

 

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

 

 

 

 

SUBTOTAL - CAPITAL OUTSIDE OF THE FACILITY

 

$

[***]

 

 

 

 

 

TOTAL ESTIMATED INITIAL CAPITAL INVESTMENT

 

$

[***]

 

 

Notes:

[***]

[***]

 

All estimates subject to change, including [***].

Does not include [***].

 

Does not include approximately $[***], which will be used in part to [***].

 

Does not include approximately $[***] that could be used for [***].

 

***Confidential Treatment Requested

 



 

EXHIBIT C

 

MANUFACTURING RESPONSIBILITIES DOCUMENT

 

Table of Contents

 

I.

[***]

2

II.

[***]

6

III.

[***]

7

IV.

[***]

8

V.

[***]

9

VI.

[***]

10

VII.

[***]

11

VIII.

[***]

11

IX.

[***]

12

X.

[***]

16

XI.

[***]

16

XII.

[***]

18

XIII.

[***]

20

 

***Confidential Treatment Requested

 



 

EXHIBIT D

 

QUALITY AGREEMENT

Table of Contents

 

I.                                         [***]

II.                                     [***]

III.                                 [***]

IV.                                 [***]

1.    [***]

2.    [***]

3.    [***]

4.    [***]

5.    [***]

6.    [***]

7.    [***]

8.    [***]

9.    [***]

10.  [***]

11.  [***]

12.  [***]

13.  [***]

14.  [***]

15.  [***]

16.  [***]

17.  [***]

18.  [***]

19.  [***]

20.  [***]

21.  [***]

22.  [***]

23.  [***]

24.  [***]

25.  [***]

26.  [***]

27.  [***]

28.  [***]

29.  [***]

30.  [***]

31.  [***]

32.  [***]

33.  [***]

34.  [***]

V.                               [***]

VI.                           [***]

VII.                       [***]

 

***Confidential Treatment Requested

 


 

 

EXHIBIT E

 

REIMBURSEMENT AGREEMENT

 

This REIMBURSEMENT AGREEMENT (this “Agreement”) is Exhibit E to the Exenatide Once Weekly Supply Agreement entered into as of October 16, 2008 by and between ELI LILLY AND COMPANY, a corporation organized and existing under the laws of the State of Indiana, whose principal place of business is Lilly Corporate Center, Indianapolis, Indiana, 46285, United States of America (“Lilly”) and AMYLIN PHARMACEUTICALS, INC., a corporation organized and existing under the laws of the State of Delaware, whose principal place of business is 9360 Towne Centre Drive, San Diego, California 92121, United States of America (“Amylin”).  Capitalized terms used but not otherwise defined herein shall have the meanings provided in the Collaboration Agreement (defined below).

 

WHEREAS, Lilly and Amylin are a party to that certain Collaboration Agreement, dated September 19, 2002, as amended (the “Collaboration Agreement”);

 

WHEREAS, the Collaboration Agreement provides that the Parties will share certain Development Costs and may agree in writing to share certain equipment and capital expenditures related to the Collaboration; and

 

WHEREAS, the Parties now wish to enter into this Agreement to set forth the terms upon which (i) Lilly will reimburse Amylin for certain capital expenditures related to the Collaboration and (ii) the Parties will share certain Development Costs related to EQW Product (as defined below).

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Lilly and Amylin agree as follows:

 

1.                                      Defined Terms.  The following terms shall have the meanings set forth below:

 

(a)                                  “EQW Cost of Product Sold” means, solely for purposes of calculating U.S. EQW Gross Profit and OUS EQW Gross Profit under this Agreement and for no other purpose, the Average Actual Manufacturing Cost as defined in the Exenatide Once Weekly Supply Agreement between Amylin Ohio LLC and Lilly of even date herewith (the “Supply Agreement”).

 

(b)                                  “EQW Manufacturing Development Costs” shall mean those Development Costs specifically related to developing the ability to Manufacture EQW Product, including, without limitation, Manufacturing process development and Manufacturing and quality assurance

 

1



 

technical support, until such time as Manufacturing of EQW Product intended for commercial sale commences.  For purposes of clarification, EQW Manufacturing Development Costs shall not include any Development Costs which are solely attributable to clinical studies of EQW Product, but may include costs relating to manufacturing development irrespective of where those costs were incurred.  All Facility personnel costs will be charged at actual FTE cost.

 

(c)                                  “EQW Next Generation Pen” shall mean the disposable injection system(s) being developed by the Parties for administering EQW Product, including any components thereof, the cartridge, and all associated manufacturing, labeling, filling, and packaging components, individually or incorporated into sub-assemblies.

 

(d)                                  “EQW Product” shall mean the Product developed as a fixed-dose injection of exenatide administered once per week for diabetes and any other Indications for which such Product may be approved for use.

 

(e)                                  “Facility” means that certain manufacturing facility being built by Amylin Ohio LLC and located at 8814 Trade Point Drive, West Chester, Ohio, as such facility may from time to time be improved, expanded or altered.

 

(f)                                    “OUS EQW Anniversary Date” means the date that is 5 years after the Product Launch of the EQW Product in any of the United Kingdom, France, Germany, Italy, Spain or Japan.

 

(g)                                 “OUS EQW Gross Profit” means, for any period, the Net Sales of the EQW Product Manufactured at the Facility and sold outside the U.S.  less the sum of (a) EQW Cost of Product Sold for such EQW Product and (b) Lilly’s actual costs (calculated in accordance with U.S. GAAP) for labeling and packaging EQW Product Manufactured at the Facility and sold outside the U.S.  For sake of clarification, for purposes of this Agreement, OUS EQW Gross Profits shall not include any royalty payments to Amylin.

 

(h)                                 “Total EQW Gross Profit” means, for any period, the U.S. EQW Gross Profit plus the OUS EQW Gross Profit.

 

(i)                                    “True Up Date” shall mean the last day of the [***] in which the OUS EQW Anniversary Date falls.

 

(j)                                    “U.S. EQW Gross Profit” means, for any period, the Net Sales of the EQW Product Manufactured at the Facility and sold in the U.S., less the EQW Cost of Product Sold for such EQW Product.

 

2.                                      Financing Payment.  Within five business days after the Effective Date, Lilly shall pay to Amylin a total of $125,000,000, representing the amount agreed upon by Amylin and Lilly (subject to the terms of this Agreement) as an appropriate financing charge for Lilly’s share of the portion of the Initial Capital Investment for the Facility, which for purposes of this Exhibit E is currently anticipated to be $510 million.

 

3.                                      EQW Gross Profit Calculations.  Within [***] after the True Up Date, Amylin shall prepare a report of U.S. EQW Gross Profit and Lilly shall prepare a report of OUS EQW Gross

 

***Confidential Treatment Requested

 

2



 

Profit, in each case covering the [***] period preceding the True Up Date.  Such reports prepared by one Party may be audited by the other Party pursuant to the provisions of Section 4.9(e) of the Collaboration Agreement (which audits shall not count towards any maximum number of audits otherwise permitted pursuant to Section 4.9(e) of the Collaboration Agreement).  Upon completion of such reports, the Parties shall determine the percentage of Total EQW Gross Profit made up of OUS EQW Gross Profit and US EQW Gross Profit for the [***] period covered by the reports (such percentages, the “Current OUS EQW Percentage” and the “Current US EQW Percentage,” respectively).  Promptly following the True Up Date the Parties shall also attempt in good faith to agree on an a projection of the percentage of Total EQW Gross Profits that OUS EQW Gross Profits and US EQW Gross Profits will make up over the [***] period following the True Up Date (such percentages, the “Projected OUS EQW Percentage” and the “Projected US EQW Percentage,” respectively).  If the Parties are unable to agree upon the Projected OUS EQW Percentage and the Projected US EQW Percentage within 30 days following the True Up Date, the Projected OUS EQW Percentage and the Projected US EQW Percentage shall be derived from the last global revenue forecast approved by either the Alliance Steering Committee (ASC) or the Global Development and Commercialization Committee (GDCC) (or their successor committees, if applicable), as appropriate.  The average of the Current OUS EQW Percentage and the Projected OUS EQW Percentage shall be the “Actual OUS EQW Percentage.”  The average of the Current US EQW Percentage and the Projected US EQW Percentage shall be the “Actual US EQW Percentage.”  The sum of (a) [***]% of the Actual OUS EQW Percentage and (b) an amount equal to [***]% of the Actual U.S. EQW Percentage shall be the “Lilly Percentage.”

 

4.                                      True Up Payment.

 

(a)                                  If the Lilly Percentage is less than [***]%, then promptly after the Lilly Percentage is finally determined pursuant to Section 3 hereof (including resolution of any audits), Amylin shall pay to Lilly an amount equal to $[***], minus (ii) the Actual OUS EQW Percentage multiplied by $[***], plus simple interest calculated at [***]% per year from the Effective Date to the True Up Date.

 

(b)                                  If the Lilly Percentage is more than [***]%, then promptly after the Lilly Percentage is finally determined pursuant to Section 3 hereof (including resolution of any audits), Lilly shall pay to Amylin an amount equal to (i) the Actual OUS EQW Percentage multiplied by $[***], minus (ii) $[***] plus simple interest calculated at [***]% per year from the Effective Date to the True Up Date.

 

(c)                                  In the event the portion of the Initial Capital Investments in the Facility is [***]% more or less than $[***] then the $[***] amount set forth in Sections 4(a) and 4(b) above shall be appropriately adjusted.

 

5.                                      EQW Manufacturing Development Costs.  Within five Business Days after the Effective Date, Lilly shall make a payment to Amylin equal to [***]% of the aggregate EQW Manufacturing Development Costs from [***] through [***].  Beginning with the [***] settlement between the Parties for the [***] ended [***], Lilly will pay [***]% of EQW Manufacturing Development Costs for each [***] subsequent to the [***] ended [***].  Lilly may audit the capital expenditures allocated to the Facility, as well as the EQW Manufacturing

 

***Confidential Treatment Requested

 

3



 

Development Costs, pursuant to the provisions of Section 4.9(e) of the Collaboration Agreement (which audits shall not count towards any maximum number of audits otherwise permitted pursuant to Section 4.9(e) of the Collaboration Agreement).

 

6.                                      EQW Next Generation Pen and Device Development and Manufacturing Agreement.  Promptly after the Effective Date the Parties agree to negotiate in good faith to provide for the treatment of investments required for the EQW Next Generation Pen and to provide for the treatment of reimbursement issues to Lilly for investments made by Lilly and not reimbursed by Amylin under that certain Device Development and Manufacturing Agreement dated July 1, 2003 and (b) Amylin for investments made by Amylin directly attributable to exenatide and not reimbursed by Lilly in accordance with the Collaboration Agreement.  The resolution of such issues shall occur within 180 days of the Effective Date and shall either result in a reimbursement structure substantially similar to that applied to the Facility and contemplated by this Agreement, or shall result in the Parties paying their respective portions of the Development Costs and capital investments related to the EQW Next Generation Pen which shall incorporate a credit for investments previously made by Lilly on behalf of the Collaboration under such Device Development and Manufacturing Agreement, including reimbursement of financing charges incurred by Lilly.

 

7.                                      Entire Agreement.  This Agreement, the Supply Agreement, and the Collaboration Agreement embody the entire understanding of the Parties and shall supersede all previous agreements, communications, representations and understandings, whether oral, written or otherwise, between the Parties relating to the subject matter hereof.  Except as specifically set forth in this Agreement, the terms and conditions of the Collaboration Agreement shall remain in full force and effect.

 

8.                                      Governing Law.  This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, excluding its conflicts of laws principles.

 

9.                                      Counterparts.  This Agreement may be executed in counterparts, each of which shall be deemed an original document, and all of which, together with this writing, shall be deemed one instrument.

 

[Signature Page Follows]

 

4



 

IN WITNESS WHEREOF, the Parties hereto have duly executed this Reimbursement Agreement as of the Effective Date.

 

 

ELI LILLY AND COMPANY

 

AMYLIN PHARMACEUTICALS, INC.

 

 

 

By:

/S/ JOHN C. LECHLEITER

 

By:

/S/ MARK G. FOLETTA

 

 

 

Name:

John C. Lechleiter

 

Name:

Mark G. Foletta

 

 

 

Title:

President and Chief Executive Officer

 

Title:

Senior Vice President, Finance and Chief Financial Officer

 



 

EXHIBIT F

 

ESTIMATED EQW MANUFACTURING INITIAL CAPITAL INVESTMENT - OUTSIDE OF THE FACILITY

 

EQW-Dedicated Capital Outside of the Facility

 

 

 

[***]

 

$

[***]

 

[***]

 

$

[***]

 

 

 

 

 

TOTAL

 

$

[***]

 

 

Notes:

 

Does not include approximately $[***], which will be used in part to [***].

 

***Confidential Treatment Requested

 



 

EXHIBIT G

 

INTEREST AMORTIZATION SCHEDULE

 

 

 

Balance

 

Cumulative
Amort

 

Dec-05

 

$

[ ***]

 

$

[ ***]

 

Jan-06

 

$

[ ***]

 

$

[ ***]

 

Feb-06

 

$

[ ***]

 

$

[ ***]

 

Mar-06

 

$

[ ***]

 

$

[ ***]

 

Apr-06

 

$

[ ***]

 

$

[ ***]

 

May-06

 

$

[ ***]

 

$

[ ***]

 

Jun-06

 

$

[ ***]

 

$

[ ***]

 

Jul-06

 

$

[ ***]

 

$

[ ***]

 

Aug-06

 

$

[ ***]

 

$

[ ***]

 

Sep-06

 

$

[ ***]

 

$

[ ***]

 

Oct-06

 

$

[ ***]

 

$

[ ***]

 

Nov-06

 

$

[ ***]

 

$

[ ***]

 

Dec-06

 

$

[ ***]

 

$

[ ***]

 

Jan-07

 

$

[ ***]

 

$

[ ***]

 

Feb-07

 

$

[ ***]

 

$

[ ***]

 

Mar-07

 

$

[ ***]

 

$

[ ***]

 

Apr-07

 

$

[ ***]

 

$

[ ***]

 

May-07

 

$

[ ***]

 

$

[ ***]

 

Jun-07

 

$

[ ***]

 

$

[ ***]

 

Jul-07

 

$

[ ***]

 

$

[ ***]

 

Aug-07

 

$

[ ***]

 

$

[ ***]

 

Sep-07

 

$

[ ***]

 

$

[ ***]

 

Oct-07

 

$

[ ***]

 

$

[ ***]

 

Nov-07

 

$

[ ***]

 

$

[ ***]

 

Dec-07

 

$

[ ***]

 

$

[ ***]

 

Jan-08

 

$

[ ***]

 

$

[ ***]

 

Feb-08

 

$

[ ***]

 

$

[ ***]

 

Mar-08

 

$

[ ***]

 

$

[ ***]

 

Apr-08

 

$

[ ***]

 

$

[ ***]

 

May-08

 

$

[ ***]

 

$

[ ***]

 

Jun-08

 

$

[ ***]

 

$

[ ***]

 

Jul-08

 

$

[ ***]

 

$

[ ***]

 

Aug-08

 

$

[ ***]

 

$

[ ***]

 

Sep-08

 

$

[ ***]

 

$

[ ***]

 

Oct-08

 

$

[ ***]

 

$

[ ***]

 

Nov-08

 

$

[ ***]

 

$

[ ***]

 

Dec-08

 

$

[ ***]

 

$

[ ***]

 

Jan-09

 

$

[ ***]

 

$

[ ***]

 

Feb-09

 

$

[ ***]

 

$

[ ***]

 

Mar-09

 

$

[ ***]

 

$

[ ***]

 

Apr-09

 

$

[ ***]

 

$

[ ***]

 

May-09

 

$

[ ***]

 

$

[ ***]

 

Jun-09

 

$

[ ***]

 

$

[ ***]

 

Jul-09

 

$

[ ***]

 

$

[ ***]

 

Aug-09

 

$

[ ***]

 

$

[ ***]

 

Sep-09

 

$

[ ***]

 

$

[ ***]

 

Oct-09

 

$

[ ***]

 

$

[ ***]

 

Nov-09

 

$

[ ***]

 

$

[ ***]

 

Dec-09

 

$

[ ***]

 

$

[ ***]

 

Jan-10

 

$

[ ***]

 

$

[ ***]

 

Feb-10

 

$

[ ***]

 

$

[ ***]

 

Mar-10

 

$

[ ***]

 

$

[ ***]

 

Apr-10

 

$

[ ***]

 

$

[ ***]

 

May-10

 

$

[ ***]

 

$

[ ***]

 

Jun-10

 

$

[ ***]

 

$

[ ***]

 

Jul-10

 

$

[ ***]

 

$

[ ***]

 

Aug-10

 

$

[ ***]

 

$

[ ***]

 

Sep-10

 

$

[ ***]

 

$

[ ***]

 

Oct-10

 

$

[ ***]

 

$

[ ***]

 

Nov-10

 

$

[ ***]

 

$

[ ***]

 

Dec-10

 

$

[ ***]

 

$

[ ***]

 

Jan-11

 

$

[ ***]

 

$

[ ***]

 

Feb-11

 

$

[ ***]

 

$

[ ***]

 

Mar-11

 

$

[ ***]

 

$

[ ***]

 

Apr-11

 

$

[ ***]

 

$

[ ***]

 

May-11

 

$

[ ***]

 

$

[ ***]

 

Jun-11

 

$

[ ***]

 

$

[ ***]

 

Jul-11

 

$

[ ***]

 

$

[ ***]

 

Aug-11

 

$

[ ***]

 

$

[ ***]

 

Sep-11

 

$

[ ***]

 

$

[ ***]

 

Oct-11

 

$

[ ***]

 

$

[ ***]

 

Nov-11

 

$

[ ***]

 

$

[ ***]

 

Dec-11

 

$

[ ***]

 

$

[ ***]

 

Jan-12

 

$

[ ***]

 

$

[ ***]

 

Feb-12

 

$

[ ***]

 

$

[ ***]

 

Mar-12

 

$

[ ***]

 

$

[ ***]

 

Apr-12

 

$

[ ***]

 

$

[ ***]

 

May-12

 

$

[ ***]

 

$

[ ***]

 

Jun-12

 

$

[ ***]

 

$

[ ***]

 

Jul-12

 

$

[ ***]

 

$

[ ***]

 

Aug-12

 

$

[ ***]

 

$

[ ***]

 

Sep-12

 

$

[ ***]

 

$

[ ***]

 

Oct-12

 

$

[ ***]

 

$

[ ***]

 

Nov-12

 

$

[ ***]

 

$

[ ***]

 

Dec-12

 

$

[ ***]

 

$

[ ***]

 

Jan-13

 

$

[ ***]

 

$

[ ***]

 

Feb-13

 

$

[ ***]

 

$

[ ***]

 

Mar-13

 

$

[ ***]

 

$

[ ***]

 

Apr-13

 

$

[ ***]

 

$

[ ***]

 

May-13

 

$

[ ***]

 

$

[ ***]

 

Jun-13

 

$

[ ***]

 

$

[ ***]

 

Jul-13

 

$

[ ***]

 

$

[ ***]

 

Aug-13

 

$

[ ***]

 

$

[ ***]

 

Sep-13

 

$

[ ***]

 

$

[ ***]

 

Oct-13

 

$

[ ***]

 

$

[ ***]

 

Nov-13

 

$

[ ***]

 

$

[ ***]

 

Dec-13

 

$

[ ***]

 

$

[ ***]

 

Jan-14

 

$

[ ***]

 

$

[ ***]

 

Feb-14

 

$

[ ***]

 

$

[ ***]

 

Mar-14

 

$

[ ***]

 

$

[ ***]

 

Apr-14

 

$

[ ***]

 

$

[ ***]

 

May-14

 

$

[ ***]

 

$

[ ***]

 

Jun-14

 

$

[ ***]

 

$

[ ***]

 

Jul-14

 

$

[ ***]

 

$

[ ***]

 

Aug-14

 

$

[ ***]

 

$

[ ***]

 

Sep-14

 

$

[ ***]

 

$

[ ***]

 

Oct-14

 

$

[ ***]

 

$

[ ***]

 

Nov-14

 

$

[ ***]

 

$

[ ***]

 

Dec-14

 

$

[ ***]

 

$

[ ***]

 

Jan-15

 

$

[ ***]

 

$

[ ***]

 

Feb-15

 

$

[ ***]

 

$

[ ***]

 

Mar-15

 

$

[ ***]

 

$

[ ***]

 

Apr-15

 

$

[ ***]

 

$

[ ***]

 

May-15

 

$

[ ***]

 

$

[ ***]

 

Jun-15

 

$

[ ***]

 

$

[ ***]

 

Jul-15

 

$

[ ***]

 

$

[ ***]

 

Aug-15

 

$

[ ***]

 

$

[ ***]

 

Sep-15

 

$

[ ***]

 

$

[ ***]

 

Oct-15

 

$

[ ***]

 

$

[ ***]

 

Nov-15

 

$

[ ***]

 

$

[ ***]

 

Dec-15

 

$

[ ***]

 

$

[ ***]

 

Jan-16

 

$

[ ***]

 

$

[ ***]

 

Feb-16

 

$

[ ***]

 

$

[ ***]

 

Mar-16

 

$

[ ***]

 

$

[ ***]

 

Apr-16

 

$

[ ***]

 

$

[ ***]

 

May-16

 

$

[ ***]

 

$

[ ***]

 

Jun-16

 

$

[ ***]

 

$

[ ***]

 

Jul-16

 

$

[ ***]

 

$

[ ***]

 

Aug-16

 

$

[ ***]

 

$

[ ***]

 

Sep-16

 

$

[ ***]

 

$

[ ***]

 

Oct-16

 

$

[ ***]

 

$

[ ***]

 

Nov-16

 

$

[ ***]

 

$

[ ***]

 

Dec-16

 

$

[ ***]

 

$

[ ***]

 

Jan-17

 

$

[ ***]

 

$

[ ***]

 

Feb-17

 

$

[ ***]

 

$

[ ***]

 

Mar-17

 

$

[ ***]

 

$

[ ***]

 

Apr-17

 

$

[ ***]

 

$

[ ***]

 

May-17

 

$

[ ***]

 

$

[ ***]

 

Jun-17

 

$

[ ***]

 

$

[ ***]

 

Jul-17

 

$

[ ***]

 

$

[ ***]

 

Aug-17

 

$

[ ***]

 

$

[ ***]

 

Sep-17

 

$

[ ***]

 

$

[ ***]

 

Oct-17

 

$

[ ***]

 

$

[ ***]

 

Nov-17

 

$

[ ***]

 

$

[ ***]

 

Dec-17

 

$

[ ***]

 

$

[ ***]

 

Jan-18

 

$

[ ***]

 

$

[ ***]

 

Feb-18

 

$

[ ***]

 

$

[ ***]

 

Mar-18

 

$

[ ***]

 

$

[ ***]

 

Apr-18

 

$

[ ***]

 

$

[ ***]

 

May-18

 

$

[ ***]

 

$

[ ***]

 

Jun-18

 

$

[ ***]

 

$

[ ***]

 

Jul-18

 

$

[ ***]

 

$

[ ***]

 

Aug-18

 

$

[ ***]

 

$

[ ***]

 

Sep-18

 

$

[ ***]

 

$

[ ***]

 

Oct-18

 

$

[ ***]

 

$

[ ***]

 

Nov-18

 

$

[ ***]

 

$

[ ***]

 

Dec-18

 

$

[ ***]

 

$

[ ***]

 

Jan-19

 

$

[ ***]

 

$

[ ***]

 

Feb-19

 

$

[ ***]

 

$

[ ***]

 

Mar-19

 

$

[ ***]

 

$

[ ***]

 

Apr-19

 

$

[ ***]

 

$

[ ***]

 

May-19

 

$

[ ***]

 

$

[ ***]

 

Jun-19

 

$

[ ***]

 

$

[ ***]

 

Jul-19

 

$

[ ***]

 

$

[ ***]

 

Aug-19

 

$

[ ***]

 

$

[ ***]

 

Sep-19

 

$

[ ***]

 

$

[ ***]

 

Oct-19

 

$

[ ***]

 

$

[ ***]

 

Nov-19

 

$

[ ***]

 

$

[ ***]

 

Dec-19

 

$

[ ***]

 

$

[ ***]

 

Jan-20

 

$

[ ***]

 

$

[ ***]

 

Feb-20

 

$

[ ***]

 

$

[ ***]

 

Mar-20

 

$

[ ***]

 

$

[ ***]

 

Apr-20

 

$

[ ***]

 

$

[ ***]

 

May-20

 

$

[ ***]

 

$

[ ***]

 

Jun-20

 

$

[ ***]

 

$

[ ***]

 

Jul-20

 

$

[ ***]

 

$

[ ***]

 

Aug-20

 

$

[ ***]

 

$

[ ***]

 

Sep-20

 

$

[ ***]

 

$

[ ***]

 

Oct-20

 

$

[ ***]

 

$

[ ***]

 

Nov-20

 

$

[ ***]

 

$

[ ***]

 

Dec-20

 

$

[ ***]

 

$

[ ***]

 

 

***Confidential Treatment Requested

 



 

EXHIBIT H

 

ESTIMATE OF ACTUAL MANUFACTURING COSTS TEMPLATE

 

Section 1.1 & 1st 3.3 Exhibit

Actual Manufacturing Costs

Q1 2XXX

 

 

 

US

 

OUS

 

 

 

 

 

 

 

Headcount

 

 

 

 

 

Contractors

 

 

 

 

 

 

 

 

 

 

 

Compensation & Benefits

 

 

 

 

 

Depreciation

 

 

 

 

 

Maintenance/Repair/Utilities

 

 

 

 

 

Purchased Services/Professional/Contractors

 

 

 

 

 

Supplies & Materials

 

 

 

 

 

Other Site Expenses

 

 

 

 

 

San Diego QC Lab & Depr of sites in Exh X

 

 

 

 

 

Other San Diego Allocations In

 

 

 

 

 

Packaging Depr & Other Related Exp

 

 

 

 

 

Factory & Inventory Losses

 

 

 

 

 

Other Variances/PPV/Use Yield

 

 

 

 

 

Royalty Expense

 

 

 

 

 

Total Expense

 

 

 

 

 

 

 

 

 

 

 

Production Volumes

 

 

 

 

 

 

 

 

 

 

 

Per Unit COPS:

 

 

 

 

 

Raw Materials Excluding Delivery Device

 

 

 

 

 

Device Delivery

 

 

 

 

 

Packaging Materials & Expense

 

 

 

 

 

Labor

 

 

 

 

 

Depreciation

 

 

 

 

 

Overhead

 

 

 

 

 

Total Pen Cost

 

 

 

 

 

 



 

EXHIBIT I

 

SCOPE OF THE RULE OF LILLY’S PERSON IN THE PLANT

 

Premise: The relationship between Lilly and Amylin is as collaborative partners. Amylin is responsible for the day to day manufacturing operations at the Ohio Site and Lilly will have access and rights that would be expected under a typical collaborative agreement.

 

1. The Lilly Partner in the Plant (the “PIP”) shall be a member of the Facility senior staff and subsequently involved in meetings where EQW is discussed. The PIP may elect to involve Lilly subject matter experts (“SMEs”) and secure their attendance at key meetings in order to resolve issues or create improvements. Typical use of SMEs may include areas such as supply chain, technical/process, finance, Quality, etc.

 

2. The PIP shall have complete exposure to all EQW subjects and information. Said exposure and information shall be open and immediate between the Parties.

 

3. The PIP will not be involved in Non-EQW activities or topics such as Human Resources and/or Amylin internal business activities that do not impact EQW.

 

4. The PIP will abide with all Facility policies, practices and procedures at all times. Amylin will be responsible to assure that Facility policies, practices and procedures do not conflict with this Agreement.

 

5. The PIP will have access to all EQW processes or functions in so far as said access does not jeopardize personal safety or process integrity. Amylin and Lilly agree that the PIP will not direct Amylin employees.

 

6. It is the PIP’s responsibility to engage and discuss all significant concerns regarding EQW with Amylin’s Facility General Manager (the “GM”) prior to discussing with the Facility senior staff.

 

7. Lilly acknowledges the GM’s responsibility of providing direction and accountability of for the Facility. As such, the GM is expected to have decision making responsibility aligned with meeting the approved annual plan and other objectives for the Facility. If the GM and the PIP are not aligned on a significant decision and/or direction, each of them will seek to involve appropriate SMEs and use of other tools (such as the decision making tool) to further inform the decision as appropriate. If the GM and the PIP are still unable to reach alignment on decision/direction, then they will take the issue to the MSC chairs for resolution. Lilly and Amylin agree that action will not be taken on the disputed decision/direction until agreement can be reached.

 

If Product Quality and/or personnel safety would be jeopardized due to a delay in the decision/direction, then the GM has the responsibility to make the decision and will notify the PIP and the MSC chairs of the decision immediately. All efforts will be taken to resolve time-sensitive issues in an expedient manner.

 

8. It is understood that the management of the Facility is and will be governed by the good relationship of the Parties. The parties agree that appointing the appropriate individuals into the GM and the PIP roles that are adept at working collaborative partnerships will be critical to the future success of the Facility.

 

While all the above are words to try and indicate the best behaviors between partners; they are only as strong as the good will and intentions of the partners to do the best for their company’s and their patients.

 



EX-10.44 5 a2190933zex-10_44.htm EXHIBIT 10.44

Exhibit 10.44

 

LOAN AGREEMENT

 

BETWEEN

 

AMYLIN PHARMACEUTICALS, INC.

 

AND

 

ELI LILLY AND COMPANY

 



 

LOAN AGREEMENT

 

THIS LOAN AGREEMENT (the “Loan Agreement”) is made as of this 16th day of October, 2008 by and between AMYLIN PHARMACEUTICALS, INC., a Delaware corporation, having a principal place of business at 9360 Towne Center Drive, San Diego, California 92121 (“Amylin”), and ELI LILLY AND COMPANY, an Indiana corporation having a principal place of business at Lilly Corporate Center, Indianapolis, Indiana 46285 (“Lilly”).

 

RECITALS

 

WHEREAS, Amylin and Lilly have entered into that certain Collaboration Agreement dated as of September 19, 2002 as the same has, and shall hereafter be, amended from time to time  (the “Collaboration Agreement”);

 

WHEREAS, Amylin and Lilly have agreed to enter into this Loan Agreement pursuant to which Amylin may obtain credit from Lilly, subject to the terms and conditions stated herein, for amounts up to the Loan Commitment; and

 

WHEREAS, Lilly is willing to provide such credit to and in favor of Amylin, subject to the terms and conditions of this Loan Agreement.

 

NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto, intending to be legally bound, do hereby agree as follows:

 

AGREEMENT

 

Section 1.                                          DEFINITIONS

 

1.1                               Defined Terms. Unless otherwise defined in this Loan Agreement, all capitalized terms shall have the meanings given them in the Collaboration Agreement. As used in this Loan Agreement, the following terms shall have the following respective meanings:

 

“Advance” means the loans made, or to be made, pursuant to Section 2 of this Loan Agreement.

 

“Advance Period” has the meaning specified in Section 2.1.

 

Amylin Ohio LLC” means Amylin’s wholly-owned subsidiary organized as a Delaware Limited Liability Company.

 

“Borrowing Request” has the meaning set forth in Section 2.2.

 

“Business Day” means any day, other than a Saturday, Sunday or holiday.

 

2



 

Change in Control” means a transaction other than a bona fide equity financing or series of financings in which 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 Amylin ordinarily entitled to vote in the election of directors, empowering such “person” or “group” to elect a majority of the Board of Directors of Amylin, who did not have such power before such transaction

 

“Collaboration Agreement” has the meaning specified in the Recitals.

 

“Effective Date” has the meaning specified in Section 10.9.

 

“EQW Product” means the Product developed as a fixed-dose injection of exenatide administered once per week for any Indication for which such Product may be approved for use.

 

“Event of Default” means any of those conditions or events listed in Section 8 of this Loan Agreement.

 

“Facility” means that certain manufacturing facility being built by Amylin Ohio LLC and located at 8814 Trade Point Drive, West Chester, Ohio, as such facility may from time to time be improved, expanded or altered.

 

“GAAP” means United States generally accepted accounting principles (including principles of consolidation), in effect from time to time, consistently applied.

 

“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

 

“Impairment Charge” means any impairment or write-off recorded by Amylin or Amylin Ohio LLC under GAAP of all or substantially all of the non-depreciated capital investments in and for the Facility.

 

“Indebtedness” means, as of any given time, Amylin’s entire indebtedness to Lilly as of such time arising under any of the Loan Documents in respect of principal, interest, fees, costs or otherwise.

 

“LIBOR” means the average of the 3-month London Inter-Bank Offer Rate compiled by the British Bankers’ Association for deposits denominated in dollars (as reflected on the applicable Telerate screen) for the five (5) business days prior to the day Lilly disburses an Advance(s) to Amylin.

 

“Loan Commitment” means the principal amount of $165,000,000.

 

“Loan Documents” means collectively, this Loan Agreement, the Note, and any other agreement or instrument executed pursuant to or in connection with the Obligations, as such documents may be amended, modified, supplemented or restated from time to time.  Loan Documents do not include the Collaboration Agreement.

 

3



 

“Material Adverse Effect” means a material adverse effect upon: (a) the business, condition (financial or otherwise), operations, performance or assets of Amylin taken as a whole, (b) the ability of Amylin to perform its obligations under the Loan Documents, or (c) the ability of Lilly to enforce the Obligations.

 

“Maturity Date” means thirty-six (36) months following the date on which the Loan Commitment shall have been fully advanced; provided, however, that the Maturity Date shall be no earlier than December 1, 2012 and no later than June 30, 2014.

 

“Note” means the promissory note executed by Amylin evidencing the Indebtedness, substantially in the form of Exhibit A attached hereto.

 

“Obligations” means all Indebtedness, liabilities, obligations, covenants and duties arising under any of the Loan Documents owing by Amylin to Lilly whether direct or indirect, absolute or contingent.

 

“Other Material Indebtedness” means any indebtedness of Amylin for borrowed money other than the Indebtedness, to the extent the aggregate amount outstanding, together with all unfunded amounts committed in connection therewith, exceeds $30,000,000.

 

 “SEC” means the United States Securities and Exchange Commission.

 

“Supply Agreement” means the Exenatide Once Weekly Supply Agreement between Amylin Ohio LLC and Lilly of even date herewith.

 

“Term” means the period from the Effective Date until the later of (i) the expiration of the Advance Period, and (ii) the date on which all outstanding Indebtedness has been repaid in full; provided that Amylin shall be entitled to terminate this Agreement and the Term hereunder shall expire upon written notice to Lilly at any time (a) prior to any Advance by Lilly to Amylin hereunder or (b) following repayment in full of all then outstanding Indebtedness.

 

1.2                               Accounting Terms.  All accounting terms not specifically defined in this Loan Agreement shall be determined and construed in accordance with GAAP.

 

1.3                               Singular and Plural.  Where the context herein requires, the singular number shall be deemed to include the plural, the masculine gender shall include the feminine and neuter genders, and vice versa.

 

1.4                               Elements of this Agreement.  When a reference is made in this Loan Agreement to the Recitals, Articles, Sections, Exhibits or Schedules, such reference is to a Recital, Article or Section of, or an Exhibit or Schedule to, this Loan Agreement, unless otherwise indicated.

 

Section 2.                                          AMOUNT AND TERMS OF CREDIT

 

2.1                               Commitment. Subject to the terms and conditions of this Loan Agreement, Lilly agrees to make Advances to Amylin from time to time beginning on December 1, 2009 and ending on June 30, 2011 (the “Advance Period”). Notwithstanding any other provision of this

 

4



 

Loan Agreement, the aggregate principal amount of all Advances outstanding at any time shall not exceed the amount of the Loan Commitment as of such time.  The Advances shall be evidenced by the Note executed by Amylin in the original principal amount of the Loan Commitment, and may be used by Amylin for general corporate purposes.

 

2.2                               Requests for Advances.  Amylin may request, no more frequently than two (2) times in any calendar year, an Advance (each such request, a “Borrowing Request”) by delivering to Lilly a written request, which must also provide disbursement instructions and include the certifications referred to in Section 4.1.  Amylin shall provide the amount (which amount shall not be less than $50,000,000) and date of such Advance (which date must be a Business Day not earlier than forty-five (45) Business Days following the date of delivery of such Borrowing Request) with respect to and at the time of each Borrowing Request; provided, however, that the date of the Advance may follow the date of delivery of the Borrowing Request by only one (1) Business Day if the full amount of such Advance is to be applied by Lilly to amounts owing by Amylin to Lilly pursuant to the Collaboration Agreement (i.e., Amylin’s application of the proceeds of such Advance must be consistent with the use of proceeds covenant set forth in this Loan Agreement).

 

2.3                               Disbursement of Advances.  Subject to the terms and conditions of this Loan Agreement, Lilly shall make available to Amylin the amount of the Advance requested in accordance with the applicable Borrowing Request.

 

Section 3.                                          INTEREST AND PAYMENTS

 

3.1                               Interest.  All Indebtedness outstanding from time to time shall bear interest at a rate per annum equal to LIBOR plus five and one quarter percent (LIBOR + 5.25%) compounded annually; provided, however, that from and during the continuance of an Event of Default, the outstanding Indebtedness shall bear interest at a rate per annum equal to the greater of (a) eleven percent (11.0%) per annum, or (b) LIBOR plus five and one quarter percent (LIBOR + 5.25%).  Interest shall be due and payable quarterly in arrears on the first Business Day of each calendar quarter.  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.

 

3.2                               Principal Repayment.  All outstanding principal, together with all accrued and unpaid interest, shall be due and payable on the Maturity Date.

 

3.3                               Early Repayment.  Notwithstanding Section 3.2 or any other provision of this Loan Agreement, all outstanding Indebtedness shall be due and payable immediately without any notice or other action by Lilly upon the occurrence of any of the following events:  (a) the consummation of a Change in Control with respect to Amylin, or (b) termination of the Collaboration Agreement by Lilly pursuant to Section 12.2 thereof.

 

3.4                               Right of Offset.  If and to the extent that Amylin defaults in the making of any payment on its due date and such default shall not have been cured, Lilly may, at its election, withhold from Amylin the amount of any milestone, royalty, expense reimbursement or other payment of any nature owing from Lilly to Amylin under the Collaboration Agreement, the

 

5



 

Supply Agreement, any Loan Document or otherwise, up to an aggregate amount equal to the amount of the defaulted payment, and apply all amounts so withheld to the repayment of the outstanding Indebtedness.  Upon such application, Lilly shall be deemed to have satisfied its obligation to pay the withheld amount to Amylin in respect of the applicable milestone, royalty, expense reimbursement or other payment, and Amylin shall be deemed to have discharged outstanding Indebtedness in the amount so applied.

 

3.5                               Right to Apply Against Impairment Charge.  If and to the extent Amylin or Amylin Ohio LLC incurs an Impairment Charge at any time during which any Indebtedness remains outstanding, then Lilly may, at its election, instruct Amylin to apply any or all of the Indebtedness outstanding against Lilly’s share of the Impairment Charge under the Supply Agreement.  Upon such application, Amylin shall be deemed to have discharged outstanding Indebtedness in an amount equal to that applied against Lilly’s share of the Impairment Charge.  Notwithstanding anything to the contrary, if Amylin or Amylin Ohio LLC incurs an Impairment Charge at any time during the Advance Period, Amylin shall be deemed, without any further action or notice required hereunder, to have forfeited its right to make any additional Borrowing Requests of Lilly.

 

3.6                               Payments on Non-Business Day.  In the event that any payment of any principal, interest, fees or any other amounts payable by Amylin under or pursuant to this Loan Agreement, or under any other Loan Document shall become due on any day which is not a Business Day, such due date shall be extended to the next succeeding Business Day, and, to the extent applicable, interest shall continue to accrue and be payable at the applicable rate(s) for and during any such extension.

 

3.7                               Payment Procedures.  All sums payable by Amylin to Lilly under or pursuant to this Loan Agreement, or any other Loan Document, whether principal, interest, or otherwise, shall be paid, when due, directly to Lilly at the office of Lilly identified in the opening paragraph of this Loan Agreement, or at such other location as Lilly may designate in writing to Amylin from time to time, in immediately available United States funds, and without setoff, deduction or counterclaim.

 

3.8                               Optional Prepayments.  Amylin may prepay the outstanding Indebtedness, in whole or in part, without premium or penalty, at any time and from time to time.  Any partial prepayment shall be applied first to any Indebtedness consisting of amounts other than principal and interest, second to accrued but unpaid interest and finally to outstanding principal.  Any partial prepayment applied to outstanding principal shall be deemed applied to the outstanding Advances in the order in which they were made.

 

3.9                               Collection Costs.  All amounts payable by Amylin under any of the Loan Documents shall be payable with all collection costs and reasonable attorneys’ fees.

 

Section 4.                                          CONDITIONS PRECEDENT

 

4.1                               Conditions Precedent to Disbursement of Advances. The obligation of Lilly to make any Advance, including the initial Advance hereunder, shall be subject to the satisfaction

 

6


 

of each of the following conditions precedent on or before any disbursement under such Advance:

 

(a)                                  Representations and Warranties.  Each of the representations and warranties of Amylin in this Loan Agreement shall be true and correct in all material respects on and as of the date of the applicable Borrowing Request with the same effect as though such representations and warranties had been made on and as of such date, except that representations and warranties made as of a particular date shall be true and correct in all material respects only as of such particular date.

 

(b)                                  Performance.  Amylin shall have performed all material obligations and agreements and complied with all material covenants to be performed or complied with by it on or before the date of the applicable Borrowing Request pursuant to the Loan Documents.

 

(c)                                  Collaboration Agreement In Effect.  The Collaboration Agreement shall not have been terminated pursuant to its terms, and neither Lilly nor Amylin shall have given written notice of its intention to terminate the Collaboration Agreement.

 

(d)                                  No Default.  No Event of Default shall have occurred and be continuing.

 

(e)                                  Certificate.  The applicable Borrowing Request shall include a certification by Amylin’s chief financial officer, dated the date of the applicable Borrowing Request, in form and substance reasonably satisfactory to Lilly, to the effect that the conditions precedent set forth in this Section 4.1 have been satisfied.

 

4.2                               Closing Documents.  Amylin shall provide to Lilly on the Effective Date each of the following:

 

(a)                                  Note.  The Note, duly authorized, executed and delivered by Amylin, and in compliance with the terms of this Loan Agreement.

 

(b)                                  Corporate Documents.  A certificate of good standing with respect to Amylin, issued by the Delaware Secretary of State and reflecting Amylin’s existence in good standing and payment of all applicable taxes and fees.

 

(c)                                  Opinion.   The written opinion of Amylin’s counsel, addressed to Lilly, in form and substance acceptable to Lilly.

 

Section 5.                                          REPRESENTATIONS AND WARRANTIES OF AMYLIN

 

Amylin hereby represents and warrants to Lilly as of the Effective Date that:

 

5.1                               Organization, Good Standing and Qualification.  Amylin is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware and has all requisite corporate power and authority to carry on its business.  Amylin is duly qualified to transact business as a corporation and is in good standing in each jurisdiction in which the failure so to qualify would have a material adverse effect upon Amylin’s ability to perform its

 

7



 

obligations under any of the Loan Documents or the validity or enforceability of, or Lilly’s rights and remedies under, this Loan Agreement or any of the other Loan Documents.

 

5.2                               Authorization; Due Execution.  Amylin has the requisite corporate power and authority to enter into each of the Loan Documents and to perform its obligations under the terms of each of the Loan Documents.  All corporate action on the part of Amylin, its officers, directors and stockholders necessary for the authorization, execution, delivery and performance of each of the Loan Documents has been taken.  Each of the Loan Documents has been duly authorized, executed and delivered by Amylin and, upon due execution and delivery by Lilly of this Loan Agreement, each of the Loan Documents will each be a valid and binding agreement of Amylin, enforceable in accordance with its respective terms, except as enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally or by equitable principles.

 

5.3                               No Defaults.  There exists no default under the provisions of any instrument or agreement evidencing, governing or otherwise relating to any Other Material Indebtedness, or with respect to any other agreement, a default under which would reasonably be expected to have a material adverse effect upon Amylin’s ability to perform its obligations under any of the Loan Documents or the validity or enforceability of, or Lilly’s rights and remedies under, this Loan Agreement or any of the other Loan Documents.

 

5.4                               SEC Filings.  Amylin has timely filed with the SEC all reports, registration statements and other documents required to be filed by it (the “SEC Filings”) under the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder (the “Securities Act”), and the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (the “Exchange Act”).  The SEC Filings were prepared in accordance with and, as of the date on which each such SEC Filing was filed with the SEC, complied in all material respects with, the applicable requirements of the Securities Act or the Exchange Act, as the case may be.  None of such SEC Filings, including, without limitation, any financial statements, exhibits and schedules included therein and documents incorporated therein by reference, at the time filed, declared effective or mailed, as the case may be, contained an untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading.  Except to the extent information contained in any of the SEC Filings has been revised, corrected or superseded by a later filing of any such form, report or document, none of the SEC Filings currently contains an untrue statement of a material fact or omits to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading.

 

5.5                               Governmental Consents.  No consent, approval, order or authorization of, or registration, qualification, designation, declaration or filing with, any federal, state, local or provincial governmental authority on the part of Amylin is required in connection with the consummation of the transactions contemplated by the Loan Documents, except for such approvals or consents as may be required under the HSR Act and such other notices as may be required or permitted to be filed with certain state and federal securities commissions after the Effective Date, which notices will be filed on a timely basis.

 

8



 

5.6                               No Conflict.  Amylin’s execution, delivery and performance of each of the Loan Documents does not violate any provision of Amylin’s Certificate of Incorporation or Bylaws, each as amended as of the date hereof (copies of which have been filed with Amylin’s SEC Filings), any provision of any order, writ, judgment, injunction, decree, determination or award to which Amylin is a party or by which it is bound, or, to Amylin’s knowledge, any law, rule or regulation currently in effect having applicability to Amylin.

 

5.7                               Litigation.  Except and to the extent disclosed to Lilly’s Deputy General Counsel by Amylin’s Deputy General Counsel or in Amylin’s SEC Filings, there is no action, litigation or proceeding pending or threatened against or involving Amylin in any court or before or by any agency or regulatory body which would reasonably be expected to result in a material judgment or liability against Amylin or which would materially and adversely affect (i) any material intellectual property of Amylin, (ii) any material portion of Amylin’s assets, (iii) the income of Amylin, or (iv) the right of Amylin to carry on its businesses as now conducted or as intended to be conducted.

 

5.8                               Payment of Taxes.  Amylin has filed all tax returns which were required to be filed by it prior to and as of the date of this Loan Agreement.  Amylin has paid all taxes and assessments which to Amylin’s knowledge are payable by it, to the extent that the same have become due and payable and before they became delinquent, except for any taxes or assessments that are being contested in good faith by appropriate proceedings properly instituted and diligently conducted.  Amylin does not know of any proposed material tax assessment against it or any of its properties for which adequate provision has not been made on its books.

 

5.9                               Compliance.  Amylin is in compliance with and in conformity to all laws, ordinances, rules, regulations and all other legal requirements, the violation of which would have a material, adverse effect on its businesses, financial condition or properties.

 

5.10                        Financial Statements.  The financial statements of Amylin included in its SEC Filings correctly and fairly present the financial condition, results of operations and cash flows of Amylin as of the dates and for the periods shown and covered thereby, in accordance with GAAP consistently applied, except that any such financial statements covering less than a full year may not include normal year-end adjustments or complete footnote disclosures.  Since the date of the most recent such financial statements, there has been no Material Adverse Effect.

 

5.11                        Full Disclosure; Survival.  None of the representations or warranties furnished by Amylin to Lilly in connection with any of the Loan Documents contains or will contain any untrue statement or omits or will omit a material fact necessary to make the statements contained therein, in light of the circumstances when made, not misleading.  All representations and warranties made by Amylin under or in connection with any of the Loan Documents shall survive the making of the Advances provided for herein and issuance and delivery of the Note to Lilly, notwithstanding any investigation made by Lilly or on Lilly’s behalf.

 

9



 

Section 6.                                          REPRESENTATIONS AND WARRANTIES OF LILLY

 

Lilly hereby represents and warrants to Amylin as of the Effective Date that:

 

6.1                               Authorization; Due Execution.  Subject to Section 10.9, Lilly has the requisite corporate power and authority to enter into this Loan Agreement and to perform its obligations under the terms of this Loan Agreement and the Loan Documents.  Subject to Section 10.9, all corporate action on the part of Lilly, its officers, directors and stockholders necessary for the authorization, execution, delivery and performance of this Loan Agreement and the Loan Documents have been taken.  Subject to Section 10.9, this Loan Agreement has been duly authorized, executed and delivered by Lilly, and, upon due execution and delivery by Amylin, this Loan Agreement will be a valid and binding agreement of Lilly, enforceable in accordance with its terms, except as enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally or by equitable principles.

 

6.2                               Purchase Entirely for Own Account.  This Loan Agreement is made with Lilly in reliance upon Lilly’s representation to Amylin, which by Lilly’s execution of this Loan Agreement it hereby confirms, that the Note will be acquired for investment for Lilly’s own account, not as a nominee or agent, and not with a view to the resale or distribution of any part thereof, and that Lilly has no present intention of selling, granting any participation in, or otherwise distributing the same.  By executing this Loan Agreement, Lilly further represents that it does not have any contract, undertaking, agreement or arrangement with any person to sell, transfer or grant participation to such person or to any third person, with respect to the Note.

 

6.3                               Disclosure of Information.  Lilly has received all the information that it has requested and that it considers necessary or appropriate for deciding whether to enter into this Loan Agreement.  Lilly further represents that it has had an opportunity to ask questions and receive answers from Amylin regarding the terms and conditions of the offering of the Note.

 

6.4                               Investment Experience.  Lilly is an investor in securities of companies in the development stage and acknowledges that it is able to fend for itself, can bear the economic risk of its investment and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of the investment in the Note.  Lilly also represents it has not been organized solely for the purpose of acquiring the Note.

 

6.5                               Accredited Investor.  Lilly is an “accredited investor” as such term is defined in Rule 501 of the General Rules and Regulations prescribed by the SEC pursuant to the Securities Act.

 

6.6                               Restricted Securities.  Lilly understands that (a) the Note has not been registered under the Securities Act by reason of a specific exemption therefrom, that such securities must be held by it indefinitely and that Lilly must, therefore, bear the economic risk of such investment indefinitely, unless a subsequent disposition thereof is registered under the Securities Act or is exempt from such registration; and (b) each certificate representing the Note will be endorsed with the following legend:

 

10



 

THIS PROMISSORY NOTE HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.  NO SALE OR DISPOSITION MAY BE EFFECTED EXCEPT IN COMPLIANCE WITH RULE 144 UNDER SAID ACT OR AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL FOR THE HOLDER, SATISFACTORY TO THE COMPANY, THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE ACT OR RECEIPT OF A NO-ACTION LETTER FROM THE SECURITIES AND EXCHANGE COMMISSION.;

 

and (c) Amylin will instruct any transfer agent not to register the transfer of the Note (or any portion thereof) unless the conditions specified in the foregoing legend are satisfied, until such time as a transfer is made in compliance with the Securities Act and this Loan Agreement.

 

Section 7.                                          COVENANTS

 

Amylin covenants and agrees that, during the Term, it will:

 

7.1                               Maintenance of Existence and Rights.  Maintain and preserve in full force and effect its existence and all rights, contracts, licenses, leases, qualifications, privileges, franchises and other authority necessary for the conduct of its business, and qualify and remain qualified to do business in each jurisdiction in which such qualification is material to its business and operations or ownership of its properties, except where the lapsing of any of the foregoing would not cause or result in a material adverse effect upon Amylin’s ability to perform its obligations under any of the Loan Documents or the validity or enforceability of, or Lilly’s rights and remedies under, this Loan Agreement or any of the other Loan Documents.

 

7.2                               Governmental and Other Approvals.  Apply for, obtain and maintain in effect, as applicable, all material authorizations, consents, approvals, licenses, qualifications, exemptions, filings, declarations and registrations (whether with any court, governmental agency, regulatory authority, securities exchange or otherwise) which are necessary in connection with the execution, delivery and performance by Amylin of this Loan Agreement, the Loan Documents, or any other documents or instruments to be executed or delivered by Amylin, in connection therewith or herewith and the transactions consummated or to be consummated hereunder or thereunder.

 

7.3                               Compliance with Laws.  Comply in all material respects with all laws, rules and regulations applicable to Amylin, except where Amylin’s failure to comply with any of the foregoing would not cause or result in a material adverse effect upon Amylin’s ability to perform its obligations under any of the Loan Documents or the validity or enforceability of, or Lilly’s rights and remedies under, this Loan Agreement or any of the other Loan Documents.

 

7.4                               Use of Proceeds.  Use the proceeds of the Advances solely for business purposes and not for personal, family, household or agricultural purposes.

 

7.5                               Payment of Taxes.  Pay and discharge (a) all taxes, assessments and governmental charges or levies imposed upon it or its income or property prior to the date on which penalties attach thereto and (b) all lawful claims and debts which, if unpaid, might become

 

11



 

a lien upon any of its property; provided that Amylin shall not be required to pay any such tax, assessment, charge, levy, claim or debt for which Amylin has obtained a bond or insurance, or for which it has established a reserve, if the payment thereof is being contested in good faith and by appropriate proceedings which are being reasonably and diligently pursued.

 

7.6                               Financial and Other Reports.  Maintain a standard system of accounting in accordance with GAAP and, except to the extent publicly available in the SEC’s EDGAR System, furnish or cause to be furnished to Lilly:

 

(a)                                  As soon as practicable, and in any event within forty-five (45) days (or such shorter period of time as is required by the SEC for filing of quarterly financial statements) after the end of each of the first three fiscal quarters in each fiscal year, the consolidated balance sheet of Amylin and its subsidiaries as at the end of such period and the related consolidated statements of income and cash flows of Amylin and its subsidiaries for such fiscal quarter and for the period from the beginning of the then current fiscal year to the end of such fiscal quarter, certified by the chief financial officer or treasurer of Amylin as fairly presenting in all material respects the consolidated financial position of Amylin and its subsidiaries as at the dates indicated and the consolidated results of their operations and cash flows for the periods indicated in accordance with GAAP.  Delivery within the time period specified above of copies of Amylin’s Quarterly Reports on Form 10-Q prepared in compliance with the requirements of the Exchange Act, in the form filed with the SEC, shall be deemed to satisfy the requirements of this paragraph.

 

(b)                                  As soon as practicable, and in any event within ninety (90) days (or such shorter period of time as is required by the SEC for filing of annual financial statements) after the end of each fiscal year, (i) the consolidated balance sheet of Amylin and its subsidiaries as at the end of such fiscal year and the related consolidated statements of income, stockholders’ equity and cash flows of Amylin and its subsidiaries for such fiscal year and, in comparative form the corresponding figures for the previous fiscal year and (ii) an audit report on the items listed in clause (i) hereof of independent certified public accountants of recognized national standing, which audit report shall be unqualified and shall state that such financial statements fairly present in all material respects the consolidated financial position of Amylin and its subsidiaries as at the dates indicated and the consolidated results of their operations and cash flows for the periods indicated in conformity with GAAP and that the examination by such accountants in connection with such consolidated financial statements has been made in accordance with generally accepted auditing standards.  Delivery within the time period specified above of Amylin’s Annual Report on Form 10-K for such fiscal year prepared in accordance with the requirements of the Exchange Act, in the form filed with the SEC, shall be deemed to satisfy the foregoing requirements of this paragraph; provided that the auditors’ report contained therein satisfies the requirements specified in clause (ii) above.

 

(c)                                  Such other reports and additional financial and other information relating to the business, affairs and financial condition of Amylin as Lilly reasonably may request in writing from time to time (subject to Amylin’s obligations to third parties and provided that Amylin shall have no obligation to provide access to information that it deems highly confidential).  Any information disclosed to Lilly pursuant to this Agreement shall be deemed

 

12


 

Amylin Confidential Information subject to the provisions of Article 6 of the Collaboration Agreement.

 

7.7                               Litigation.  Notify Lilly in writing, promptly upon learning thereof, of any litigation commenced against Amylin which would reasonably be expected to have a Material Adverse Effect.

 

7.8                               Notices/Material Developments.  Promptly (and in any event within three (3) calendar days) after obtaining knowledge of the occurrence of any event that has resulted in or would reasonably be expected to result in a Material Adverse Effect, deliver to Lilly a statement of the chief executive officer or chief financial officer of Amylin setting forth the details of each such event and the action which Amylin has taken and proposes to take with respect thereto.  In addition, Amylin shall immediately inform Lilly by written notice of the occurrence of any event or condition of any nature which constitutes an Event of Default.

 

Section 8.                                          EVENTS OF DEFAULT

 

8.1                               Events of Default.  The occurrence or existence of any of the following conditions or events shall constitute an “Event of Default” hereunder:

 

(a)                                  Failure to Pay.  Amylin shall fail to pay, when due, any principal, interest or other sums due to Lilly under this Loan Agreement and such failure shall continue for a period of five (5) days;

 

(b)                                  Other Defaults Under the Loan Documents.  Any default in the observance or performance of any of the other conditions, covenants or agreements of Amylin set forth in this Loan Agreement or in any Loan Document, and continuance thereof for a period of thirty (30) days;

 

(c)                                  Insolvency; Bankruptcy.  If (i) Amylin becomes insolvent or generally fails to pay, or admits in writing its inability to pay, its debts as they mature, or applies for, consents to, or acquiesces in the appointment of a trustee, receiver, liquidator, conservator or other custodian for itself, or a substantial part of its property, or makes a general assignment for the benefit of creditors; (ii) Amylin files a voluntary petition in bankruptcy or a trustee, receiver, liquidator, conservator or other custodian is appointed for Amylin or for a substantial part of its property; (iii) any bankruptcy, reorganization, debt arrangement, or other proceedings under any bankruptcy or insolvency law, or any dissolution or liquidation proceeding, is instituted by or against Amylin, and the same is consented to or acquiesced by Amylin,  or otherwise remains undismissed for sixty (60) days; or (iv) any warrant of attachment is issued against any substantial part of the property of Amylin which is not released within thirty (30) days of service thereof.

 

(d)                                  Representations and Warranties.  Any representation or warranty made by Amylin in any Loan Document shall fail to be true and correct in any material respect when made or deemed to have been made.

 

(e)                                  Default with Respect to Other Material Indebtedness.  Amylin shall default with respect to (i) any payment of principal of or interest on any Other Material

 

13



 

Indebtedness and fails to cure such default within the required cure period, or (ii) the performance of any other covenant, term or condition contained in any agreement or instrument under which any Other Material Indebtedness is created or governed if the effect of such performance default is to accelerate the maturity of any Other Material Indebtedness or to permit the holder of any such Other Material Indebtedness to accelerate the maturity of any Other Material Indebtedness.

 

Section 9.                                          LILLY’S RIGHTS AND REMEDIES

 

9.1                               Rights and Remedies.  Upon the occurrence and during the continuance of an Event of Default, Lilly 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 Amylin:

 

(a)                                  Declare all Obligations immediately due and payable (provided, that upon the occurrence of an Event of Default described in Section 8.1(c), all Obligations shall become immediately due and payable without any action by Lilly);

 

(b)                                  Cease advancing money or extending credit to or for the benefit of Amylin under this Loan Agreement; and

 

(c)                                  Terminate this Loan Agreement as to any future liability or obligation of Lilly, but without affecting the Obligations of Amylin to Lilly.

 

9.2                               Waiver of Defaults.  No Event of Default shall be waived by Lilly except in a written instrument specifying the scope and terms of such waiver and signed by an authorized officer of Lilly, and such waiver shall be effective only for the specific times and purposes given.  No single or partial exercise of any right, power or privilege hereunder, nor any delay in the exercise thereof, shall preclude other or further exercise of Lilly’s rights.  No waiver of any Event of Default shall extend to any other or further Event of Default.  No forbearance on the part of Lilly in enforcing any of Lilly’s rights or remedies hereunder or under any of the other Loan Documents shall constitute a waiver of any of its rights or remedies.

 

9.3                               Remedies Cumulative.  Lilly’s rights and remedies under this Loan Agreement, the Loan Documents, and all other agreements shall be cumulative.  Lilly shall have all other rights and remedies not expressly set forth herein as provided under applicable law, or in equity.  No exercise by Lilly of one right or remedy shall be deemed an election, and no waiver by Lilly of any Event of Default on Amylin’s part shall be deemed a continuing waiver.  No delay by Lilly shall constitute a waiver, election, or acquiescence by it.  No waiver by Lilly shall be effective unless made in a written document signed on behalf of Lilly and then shall be effective only in the specific instance and for the specific purpose for which it was given.

 

9.4                               Waiver.  Amylin 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 Lilly on which Amylin may in any way be liable.

 

14



 

Section 10.                                   MISCELLANEOUS

 

10.1                        Governing Law.  This Loan Agreement, and each of the other Loan Documents shall be governed by and construed in accordance with the laws of the State of New York.

 

10.2                        Assignment.  This Loan Agreement will inure to the benefit and be binding upon each party, its successors and assigns.  The Loan Agreement may not be assigned or otherwise transferred, nor, except as expressly provided hereunder, may any right or obligation hereunder be assigned or transferred by either party without the prior written consent of the other party; provided, however, that either party may, without such consent, assign this Loan Agreement and its rights and obligations hereunder to an affiliate of such party or in connection with the transfer or sale of all or substantially all of its assets or business to which this Loan Agreement relates, or in the event of its merger or consolidation or Change in Control or similar transaction.  The rights and obligations of the parties under this Loan Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the parties.  Any attempted assignment not in accordance with this Section will be void.

 

10.3                        Entire Agreement.  This Loan Agreement, the exhibits and schedules hereto, the other Loan Documents, the Collaboration Agreement and the other documents delivered pursuant hereto constitute the full and entire understanding and agreement between the parties with regard to the subjects hereof.

 

10.4                        Severability.  In case any provision of this Loan Agreement shall be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby.

 

10.5                        Titles and Subtitles.  The titles of the sections and subsections of the Loan Agreement are for convenience of reference only and are not to be considered in construing this Loan Agreement.

 

10.6                        Notices.  All notices which are required or permitted hereunder will be in writing and sufficient if delivered personally, sent by facsimile or email to a current fax number or e-mail address for the recipient (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:

 

if to Amylin, to:

 

Amylin Pharmaceuticals, Inc.

 

 

9360 Towne Centre Drive

 

 

San Diego, California 92121

 

 

Attention: President and Chief Executive Officer

 

 

Fax No.: (858) 334-1237

 

 

E-Mail: daniel.bradbury@amylin.com

 

 

 

with a copy to:

 

Attention: General Counsel

 

 

Fax No.: (858) 754-0973

 

 

E-Mail: marcea.lloyd@amylin.com

 

15



 

if to Lilly, to:

 

Eli Lilly and Company

 

 

Lilly Corporate Center

 

 

Indianapolis, IN 46285

 

 

Attention: General Counsel

 

or to such other address as the party to whom notice is to be given may have furnished to the other party in writing in accordance herewith. Any such notice will be deemed to have been given when delivered if personally delivered or sent by facsimile on a Business Day, on the Business Day after dispatch if sent by nationally-recognized overnight courier and on the third Business Day following the date of mailing if sent by mail.

 

10.7                        Waiver.  The waiver by either party hereto of any right hereunder, or the failure to perform, or a breach by the other party will not be deemed a waiver of any other right hereunder or of any other breach or failure by said other party whether of a similar nature or otherwise.

 

10.8                        Counterparts.  This Loan Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument.

 

10.9                        Effective Date.  This Agreement shall become effective upon the date approved by Lilly’s Board of Directors (the “Effective Date”).  Lilly agrees to cause its management to recommend approval of this Agreement to its Board of Directors on or before October 20, 2008, and shall promptly notify Amylin of the Lilly Board decision regarding this Agreement.

 

[The signature page follows.]

 

16



 

WITNESS the due execution hereof as of the day and year first above written.

 

ELI LILLY AND COMPANY

AMYLIN PHARMACEUTICALS, INC.

 

 

 

 

 

 

 

 

By:

/s/ John C. Lechleiter

By:

/s/ Mark G. Foletta

 

 

 

 

Name:

John C. Lechleiter

Name:

Mark Foletta

 

 

 

 

Title:

President and Chief Executive Officer

Title:

Senior Vice President, Finance and

 

 

 

Chief Financial Officer

 

[SIGNATURE PAGE TO LOAN AGREEMENT]

 



 

EXHIBIT A

 

THIS PROMISSORY NOTE HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.  NO SALE OR DISPOSITION MAY BE EFFECTED EXCEPT IN COMPLIANCE WITH RULE 144 UNDER SAID ACT OR AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL FOR THE HOLDER, SATISFACTORY TO THE COMPANY, THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE ACT OR RECEIPT OF A NO-ACTION LETTER FROM THE SECURITIES AND EXCHANGE COMMISSION.

 

PROMISSORY NOTE

 

$165,000,000

San Diego, California

 

                , 2008

 

AMYLIN PHARMACEUTICALS , INC., a Delaware corporation (“Amylin), for value received, hereby promises to pay to the order of ELI LILLY AND COMPANY, an Indiana corporation (“Lilly”), in lawful money of the United States of America, the principal amount of $165,000,000 or the aggregate principal amount of all outstanding Advances, together with interest as provided for below, payable on the dates, in the amounts and in the manner set forth below.

 

1.              Loan Agreement.  This Promissory Note is the Note referred to in that certain Loan Agreement, dated as of October     , 2008, by and between Amylin and Lilly (as the same may be amended, supplemented, restated or otherwise modified from time to time, the “Loan Agreement”).  Capitalized terms used herein without definitions shall have the meanings given to such terms in the Loan Agreement.

 

2.              Requests for Advances.  Amylin may request an Advance by delivering to Lilly a Borrowing Request pursuant to Section 2.2 of the Loan Agreement.

 

3.              Principal Payments.  Subject to the terms and conditions of the Loan Agreement, the total outstanding balance of all Indebtedness shall be due and payable in accordance with the terms of the Loan Agreement.

 

4.              Interest.  The outstanding Indebtedness shall accrue interest at the rate or rates per annum set forth in the Loan Agreement.

 

5.              Payment on Non-Business Day.  In the event that any payment of principal, interest, fees or any other amounts payable by Amylin under or pursuant to this Note shall become due on any day which is not a Business Day, such due date shall be extended to the next succeeding Business Day, and, to the extent applicable, interest shall continue to accrue and be payable at the applicable rate for and during any such extension.

 

6.              Default.  Upon the occurrence of an Event of Default under the Loan Agreement or any of the other Loan Documents, all unpaid principal, accrued interest and other amounts owing

 

1



 

hereunder shall become immediately due and payable as provided in the Loan Agreement, the other Loan Documents and applicable law.

 

7.              Waivers.  Amylin hereby waives presentment, demand, protest, notice of dishonor, notice of demand or intent to demand, notice of acceleration or intent to accelerate, and all other notices, and Amylin agrees that no extension or indulgence to Amylin or the release or substitution of Amylin, whether with or without notice, shall affect the obligations of Amylin.  The right to plead any and all statutes of limitation as a defense to any demands hereunder is hereby waived by Amylin to the full extent permitted by law.  In addition, Amylin waives all defenses or rights to discharge available to it and waives all other suretyship defenses or rights to discharge.

 

8.              Governing Law.  This Note shall be governed by and construed in accordance with the laws of the State of New York.

 

AMYLIN:

AMYLIN PHARMACEUTICALS, INC.

 

 

 

 

 

 

 

 

By:

 

 

Its:

 

 

2



EX-10.45 6 a2190933zex-10_45.htm EXHIBIT 10.45

Exhibit 10.45

 

FIRST AMENDMENT

 

THIS FIRST AMENDMENT dated as of October 27, 2008 (this “Amendment”), among AMYLIN PHARMACEUTICALS, INC., a Delaware corporation (the “Company”), each of the Company’s subsidiaries listed on the signature pages hereto (collectively, together with the Company, the “Borrowers” and each a “Borrower”), the Lenders (as defined below) party hereto, and BANK OF AMERICA, N.A., as Administrative Agent, Collateral Agent and L/C Issuer (in such capacity, the “Administrative Agent”) for the Lenders.

 

W I T N E S S E T H:

 

WHEREAS, the Borrowers are a party to a Credit Agreement, dated as of December 21, 2007, among the Borrowers, the lenders from time to time party thereto (the “Lenders”), the Administrative Agent, and the other agents, lead arranger and book manager party thereto (the “Existing Credit Agreement”). Capitalized terms used and not otherwise defined herein shall have the meanings assigned to such terms in the Existing Credit Agreement;

 

WHEREAS, the Borrowers and the Administrative Agent are parties to a Pledge and Security Agreement, dated as of December 21, 2007 (the “Existing Security Agreement”);  and

 

WHEREAS, the parties hereto have agreed, subject to the terms and conditions hereof, to amend and modify the Existing Credit Agreement and the Existing Security Agreement as provided herein;

 

NOW THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:

 

SECTION 1.01.                                                           Amendment to Section 2.07 of the Existing Credit Agreement.  Section 2.07(a) of the Existing Credit Agreement is hereby deleted in its entirety and replaced by the following:

 

(a) Term Loans.  The Borrowers shall repay to the Term Lenders the aggregate principal amount of all Term Loans outstanding on each quarterly date set forth below in the respective amounts equal to the percentages of the Term Loans set forth below (which amounts shall be reduced as a result of the application of prepayments in accordance with the order of priority set forth in Section 2.05):

 

Date

 

Amount

 

March 23, 2009

 

6.25

%

June 22, 2009

 

6.25

%

September 21, 2009

 

6.25

%

December 21, 2009

 

6.25

%

March 22, 2010

 

6.25

%

June 21, 2010

 

6.25

%

September 21, 2010

 

6.25

%

December 21, 2010

 

56.25

%

 



 

providedhowever, that notwithstanding anything herein to the contrary, the final principal repayment installment of the Term Loans shall be repaid on the Maturity Date for the Term Facility and in any event shall be in an amount equal to the aggregate principal amount of all Term Loans outstanding on such date.

 

SECTION 1.02.                                                           Amendment to Section 6.01(c) of the Existing Credit Agreement.  Section 6.01(c) of the Existing Credit Agreement is hereby amended by deleting the phrase “but in any event at least 60 days after the end of each fiscal year of the Company” and replacing it with “but in any event no later than 60 days after the end of each fiscal year of the Company”.

 

SECTION 1.03.                                                           Amendment to Section 6.02 of the Existing Credit Agreement.   The penultimate paragraph of Section 6.02 of the Existing Credit Agreement is hereby amended by (i) replacing the reference to “Section 6.02(d)” in the first sentence thereof with a reference to “Section 6.02(c)” and (ii) replacing the reference to “Section 6.02(b)” in the second sentence thereof with a reference to “Section 6.02(a)”.

 

SECTION 1.04.                                                           Amendment to Section 8.02 of the Existing Credit Agreement. Section 8.02 of the Existing Credit Agreement is hereby deleted in its entirety and replaced by the following:

 

8.02                           Remedies upon Event of Default.  If any Event of Default occurs and is continuing, the Administrative Agent shall, at the request of, or may, with the consent of, the Required Lenders, take any or all of the following actions:

 

(a)                                  declare the commitment of each Lender to make Loans, any obligation of Bank of America to enter into Secured Hedge Agreements under the Permitted FX Facility and any obligation of the L/C Issuer to make L/C Credit Extensions to be terminated, whereupon such commitments and obligation shall be terminated;

 

(b)                                 declare the unpaid principal amount of all outstanding Loans, all interest accrued and unpaid thereon, and all other amounts owing or payable hereunder or under any other Loan Document to be immediately due and payable, without presentment, demand, protest or other notice of any kind, all of which are hereby expressly waived by the Borrowers;

 

(c)                                  require that the Borrowers Cash Collateralize the L/C Obligations (in an amount equal to the then Outstanding Amount thereof); and

 

(d)                                 exercise on behalf of itself, the Lenders and the L/C Issuer all rights and remedies available to it, the Lenders and the L/C Issuer under the Loan Documents;

 

2



 

providedhowever, that upon the occurrence of an actual or deemed entry of an order for relief with respect to the Borrowers under the Bankruptcy Code of the United States, the obligation of each Lender to make Loans, any obligation of Bank of America to enter into Secured Hedge Agreements under the Permitted FX Facility and any obligation of the L/C Issuer to make L/C Credit Extensions shall automatically terminate, the unpaid principal amount of all outstanding Loans and all interest and other amounts as aforesaid shall automatically become due and payable, and the obligation of the Borrowers to Cash Collateralize the L/C Obligations as aforesaid shall automatically become effective, in each case without further act of the Administrative Agent or any Lender.

 

SECTION 1.05.                                                           Amendment to Schedule 10.02 to the Existing Credit Agreement.  Schedule 10.02 to the Existing Credit Agreement shall be amended by adding the following website of the Company to such Schedule:  www.amylin.com.

 

SECTION 1.06.                                                           Amendment to Section 3.01 of the Existing Security Agreement.   The first sentence of the last paragraph of Section 3.01 of the Existing Security Agreement is hereby amended by deleting the reference to “clauses (i) through (iv) above” with a reference to “clauses (i) through (iii) above”.

 

SECTION 1.07.                                                           Amendment to Section 4.01(f) of the Existing Security Agreement.  The first sentence of Section 4.01(f) of the Existing Security Agreement is hereby amended by deleting the clause at the end of such sentence that begins “providedhowever” and replacing it with the following clause:

 

; providedhowever, that any Grantor shall not be required to deliver an Account Control Agreement in respect of any Deposit Account that consists solely of Excluded Collateral or is exclusively used for payroll, payroll taxes and other employee wage and benefit payments to or for the benefit of the Grantors’ employees.

 

SECTION 1.08.                                                           Representations and Warranties.  Each Borrower hereby represents and warrants to the Administrative Agent and the Lenders, as follows:

 

(a)                                  The representations and warranties of such Borrower contained in Article V of the Existing Credit Agreement, as amended hereby (the “Amended Credit Agreement”), or any other Loan Document (except for any Secured Hedge Agreements or Secured Cash Management Agreements) or which are contained in any document furnished at any time under or in connection therewith are true and correct in all material respects on and as of the date hereof and on and as of the Amendment Effective Date with the same effect as if made on and as of the date hereof or the Amendment Effective Date, as the case may be, except to the extent such representations and warranties specifically refer to an earlier date, in which case they are true and correct in all material respects as of such earlier date, and except that the representations and warranties contained in Sections 5.05(a) and (b) of the Existing Credit Agreement shall be deemed

 

3



 

to refer to the most recent statements furnished pursuant to Sections 6.01(a) and (b) thereof, respectively.

 

(b)                                 After giving effect to this Amendment, each Loan Party is in compliance with all the terms and conditions of the Amended Credit Agreement and the other Loan Documents on its part to be observed or performed and no Default or Event of Default has occurred or is continuing under the Amended Credit Agreement.

 

(c)                                  The execution, delivery and performance by such Borrower of this Amendment have been duly authorized by such Borrower.

 

(d)                                 Each of this Amendment and the Amended Credit Agreement constitutes the legal, valid and binding obligation of such Borrower, enforceable against such Borrower in accordance with its terms.

 

(e)                                  The execution, delivery, performance and compliance with the terms and provisions by such Borrower of this Amendment and the consummation of the transactions contemplated herein, do not and will not: (i) contravene the terms of any of such Borrower’s Organization Documents; (ii) conflict with or result in any breach or contravention of, or (except for the Liens created under the Loan Documents) the creation of any Lien under, (A) any material Contractual Obligation to which such Borrower is a party affecting such Borrower or the properties of such Borrower or its Subsidiaries or (B) any order, injunction, writ or decree of any Governmental Authority or any arbitral award to which such Borrower or its property is subject or (C) violate any Law.

 

SECTION 1.09.                                                           Effectiveness.  This Amendment shall become effective only upon satisfaction of the following conditions precedent (the first date upon which each such condition has been satisfied being herein called the “Amendment Effective Date”):

 

(a)                                  The Administrative Agent shall have received duly executed counterparts of this Amendment which, when taken together, bear the authorized signatures of the Borrower, the Administrative Agent and the Required Lenders.

 

(b)                                 The Administrative Agent on behalf of the Lenders shall have received such other documents, instruments and certificates as they shall reasonably request and such other documents, instruments and certificates shall be satisfactory in form and substance to the Lenders and their counsel.  All corporate and other proceedings taken or to be taken in connection with this Amendment and all documents incidental thereto, whether or not referred to herein, shall be satisfactory in form and substance to the Lenders and their counsel.

 

SECTION 1.10.                                                           APPLICABLE LAW.  THIS AMENDMENT SHALL BE GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF NEW YORK.

 

SECTION 1.11.                                                           Costs and Expenses.  The Borrowers promptly shall pay all costs and expenses of the Administrative Agent in connection with the preparation, execution and

 

4



 

delivery of this Amendment and the other instruments and documents to be delivered hereunder (including, without limitation, the reasonable fees and expenses of counsel for the Administrative Agent) in accordance with the terms of Section 10.04(a) of the Amended Credit Agreement.

 

SECTION 1.12.                                                           Loan Document; Counterparts.  This Amendment is and from and after the Amendment Effective Date shall be deemed to be a “Loan Document” under the Amended Credit Agreement. This Amendment may be executed in any number of counterparts, each of which shall constitute an original but all of which when taken together shall constitute but one agreement. Delivery by facsimile by any of the parties hereto of an executed counterpart of this Amendment shall be as effective as an original executed counterpart hereof and shall be deemed a representation that an original executed counterpart hereof will be delivered, but the failure to deliver a manually executed counterpart shall not affect the validity, enforceability or binding effect of this Amendment.

 

SECTION 1.13.                                                           Existing Credit Agreement and Existing Security Agreement.  Except as expressly set forth herein, the amendment provided herein shall not, by implication or otherwise, limit, constitute a waiver of, or otherwise affect the rights and remedies of the Lenders or the Administrative Agent under the Existing Credit Agreement, the Existing Security Agreement or any other Loan Document, nor shall it constitute a waiver of any Default or Event of Default, nor shall it alter, modify, amend or in any way affect any of the terms, conditions, obligations, covenants or agreements contained in the Existing Credit Agreement, the Existing Security Agreement or any other Loan Document.  The amendment provided herein shall apply and be effective only with respect to the provisions of the Existing Credit Agreement and the Existing Security Agreement specifically referred to by such amendment.  Except to the extent a provision in the Existing Credit Agreement or the Existing Security Agreement is expressly amended herein, the Existing Credit Agreement and the Existing Security Agreement shall continue in full force and effect in accordance with the provisions thereof.

 

[Signature pages follow]

 

5



 

IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed by their duly authorized officers, all as of the date first above written.

 

 

 

AMYLIN PHARMACEUTICALS, INC., as a Borrower

 

 

 

 

By:

 

/s/ Mark Foletta

 

Name:

     Mark Foletta

 

Title:

 

     Senior Vice President, Finance and Chief

 

 

 

     Financial Officer

 

 

 

 

 

 

AMYLIN OHIO LLC, as a Borrower

 

 

 

 

 

By:

Amylin Pharmaceuticals, Inc.,

 

 

 

its Sole Manager

 

 

 

 

 

 

 

 

By:

 

/s/ Mark Foletta

 

Name:

     Mark Foletta

 

Title:

 

     Senior Vice President, Finance and Chief

 

 

 

     Financial Officer

 

 

 

 

 

 

AMYLIN INVESTMENTS LLC, as a Borrower

 

 

 

 

 

By:

Amylin Pharmaceuticals, Inc.,

 

 

 

its Sole Manager

 

 

 

 

 

 

 

 

By:

 

/s/ Mark Foletta

 

Name:

     Mark Foletta

 

Title:

 

     Senior Vice President, Finance and Chief

 

 

 

     Financial Officer

 

First Amendment to Credit Agreement

Signature Page

 



 

 

BANK OF AMERICA, N.A., as Administrative Agent

 

 

 

 

By:

 

/s/ Brenda H. Little

 

Name:

     Brenda H. Little

 

Title:

 

     Vice President

 

First Amendment to Credit Agreement

Signature Page

 


 

 

BANK OF AMERICA, N.A., as a Revolving Credit Lender, L/C Issuer and Hedge Bank under the Permitted F/X Facility

 

 

 

 

By:

 

/s/ Karin S. Barnes

 

Name:

     Karin S. Barnes

 

Title:

 

     Senior Vice President

 

First Amendment to Credit Agreement

Signature Page

 



 

 

BANC OF AMERICA LEASING & CAPITAL, LLC, as a Term Lender

 

 

 

 

By:

 

/s/ Lori J. Noberini

 

Name:

     Lori J. Noberini

 

Title:

 

     Vice President

 

First Amendment to Credit Agreement

Signature Page

 



 

 

SILICON VALLEY BANK, as a Term Lender

 

 

 

 

By:

/s/ Sarah Larson

 

Name:   Sarah Larson

 

Title:     Relationship Manager

 

First Amendment to Credit Agreement

Signature Page

 



 

 

BMO CAPITAL MARKETS FINANCING, INC., as a Term Lender

 

 

 

 

By:

 /s/ Andrew Pluta

 

Name:

 Andrew Pluta

 

Title:

 

 Vice President, Healthcare

 

First Amendment to Credit Agreement

Signature Page

 



 

 

FIRST BANK, as a Term Lender

 

 

 

 

By:

 

/s/ Gilmore Hector

 

Name:

     Gilmore Hector

 

Title:

 

     Vice President

 

First Amendment to Credit Agreement

Signature Page

 



 

 

AIB DEBT MANAGEMENT, LIMITED, as a Term Lender

 

 

 

 

By:

 

/s/ Mia Bolin

 

Name:

     Mia Bolin

 

Title:

 

Assistant Vice President, Investment Advisor to AIB Debt Management, Limited

 

 

 

AIB DEBT MANAGEMENT, LIMITED, as a Term Lender

 

 

 

 

By:

 

/s/ Eanna P. Mulkere

 

Name:

     Eanna P. Mulkere

 

Title:

 

Assistant Vice President, Investment Advisor to AIB Debt Management, Limited

 

First Amendment to Credit Agreement

Signature Page

 



EX-10.46 7 a2190933zex-10_46.htm EXHIBIT 10.46

Exhibit 10.46

 

EXECUTION COPY

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)
and 240.24b-2

 

AMENDMENT TO THE COMMERCIAL SUPPLY AGREEMENT

 

THIS AMENDMENT TO THE COMMERCIAL SUPPLY AGREEMENT (the “Amendment”) is made and entered into effective as of December 8, 2008 (the “Amendment Date”), by and between Amylin Pharmaceuticals, Inc. (“Amylin”) and Baxter Pharmaceutical Solutions LLC (“Baxter”). Capitalized terms used in this Amendment that are not otherwise defined herein shall have the meanings ascribed to such terms in the Agreement (as defined herein).

 

WHEREAS, effective February 14, 2005, Amylin and Baxter entered into that certain Commercial Supply Agreement (the “Agreement”) wherein Baxter agreed to produce the Exenatide BID Product for Amylin pursuant to the terms and conditions contained therein; and

 

WHEREAS, Amylin and Baxter desire to amend the Agreement as set forth herein with respect to Amylin’s Annual Obligation.

 

NOW, THEREFORE, Amylin and Baxter agree as follows:

 

As of the Amendment Date, Amylin and Baxter agree that Exhibit F, as attached to the Agreement prior to the Amendment Date, shall be deleted and replaced with Exhibit F-1, attached to this Amendment.

 

The other provisions of the Agreement, not amended by this Amendment, remain in full force and effect.  This Amendment may be executed in counterparts and all such counterparts shall be treated as one and the same document.

 

IN WITNESS WHEREOF, Amylin and Baxter have executed this Amendment as of the date first above written.

 

AMYLIN PHARMACEUTICALS, INC.

BAXTER PHARMACEUTICAL SOLUTIONS LLC

 

 

By:

/S/ PAUL MARSHALL

 

By:  

/S/ BRIK V. EYRE

Name:

Paul Marshall

 

Name:

Brik V. Eyre

Title:

Vice President, Operations

 

Title:

General Manager

Date:

01/07/2009

 

Date:

01/12/2009

 



 

Exhibit F-1

 

Annual Obligation

 

YEAR

 

ANNUAL OBLIGATION

First calendar year following Regulatory Approval (2006)

 

[***]

Second calendar year following Regulatory Approval (2007)

 

[***]

Third calendar year following Regulatory Approval (2008)

 

[***]

Fourth calendar year following Regulatory Approval (2009)

 

[***]

Fifth calendar year following Regulatory Approval (2010)

 

[***]

Sixth calendar year following Regulatory Approval (2011)

 

[***]

 

***Confidential Treatment Requested

 



EX-10.47 8 a2190933zex-10_47.htm EXHIBIT 10.47

Exhibit 10.47

 

EXECUTION COPY

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 240.24b-2

 

Confidential

 

AMENDMENT TO THE AMENDED AND RESTATED

COMMERCIAL SUPPLY AGREEMENT

 

This AMENDMENT TO THE AMENDED AND RESTATED COMMERCIAL SUPPLY AGREEMENT (the “Amendment”) is made, entered into, and effective as of January 23, 2009 (the “Amendment Date”), by and between Amylin Pharmaceuticals, Inc. (“Company”) and Wockhardt UK (Holdings) Ltd, formerly CP Pharmaceuticals Ltd. (“Manufacturer”). Capitalized terms used in this Amendment that are not otherwise defined herein shall have the meanings ascribed to such terms in the Agreement (as defined herein).

 

WHEREAS, effective April 1, 2008, Company and Manufacturer entered into that certain Amended and Restated Commercial Supply Agreement (the “Agreement”) wherein Manufacturer agreed to produce Product for Company pursuant to the terms and conditions contained therein; and

 

WHEREAS, Company and Manufacturer desire to amend the Agreement as set forth herein with respect to the Company’s Period Obligations.

 

NOW, THEREFORE, Company and Manufacturer agree as follows:

 

As of the Amendment Date, Company and Manufacturer agree that Exhibit C, as attached to the Agreement prior to the Amendment Date, shall be deleted and replaced with Exhibit C-1, attached to this Amendment;

 

In consideration of this Amendment, Manufacturer hereby expressly waives and releases any and all rights under section 2.2 of the Agreement to hold the Company responsible to pay to the Manufacturer the difference between the amount invoiced to Company for its actual purchases during the third (3rd) and fourth (4th) Purchase Periods and the amount that would have been invoiced had Company purchased the minimum amount agreed to for such Purchase Periods.  For the avoidance of doubt, section 2.2 of the Agreement is still applicable to Purchase Periods five (5) and six (6) accordingly.  In exchange, Company agrees to the amounts as described in the sixth Purchase Period.  Section 9.1 of the Agreement shall be extended in accordance with Exhibit C-1. 

 



 

The other provisions of the Agreement, not amended by this Amendment, remain in full force and effect.  This Amendment may be executed in counterparts and all such counterparts shall be treated as one and the same document.

 

IN WITNESS WHEREOF, Company and Manufacturer have executed this Amendment as of the date first above written.

 

AMYLIN PHARMACEUTICALS, INC.

WOCKHARDT UK (Holdings) Ltd, formerly CP

 

PHARMACEUTICALS Ltd.

 

 

By:

/S/ PAUL MARSHALL

 

By:

/s/ Sirjiwan Singh

Name:

Paul Marshall

 

Name:

Sirjiwan Singh

Title:

Sr. Vice President, Operations

 

Title:

Managing Director

Date:

01/28/2009

 

Date:

02/02/2009

 



 

Exhibit C-1

 

Minimum Orders

 

Purchase Period

 

Date Range

 

Minimum Quantity

 

 

 

 

 

Initial Period

 

4-28-05 to 4-27-06

 

[***]

 

 

 

 

 

2nd Period

 

4-28-06 to 4-27-07

 

[***]

 

 

 

 

 

3rd Period

 

4-28-07 to 4-27-08

 

[***]

 

 

 

 

 

4th Period

 

4-28-08 to 4-27-09

 

[***]

 

 

 

 

 

5th Period

 

4-28-09 to 4-27-10

 

[***]

 

 

 

 

 

6th Period

 

4-28-10 to 9-30-11

 

[***]

 

Amendment (effective January 23, 2009) to the Amended and Restated Supply Agreement (effective 1 April 2008) provides for:

 

·                  addition of a 6th Period of [***] minimum quantity units.

·                  the total minimum quantity for the 5th and 6th Periods combined is [***] units.

·                  flexibility in the 5th and 6th Periods:

a.               5th Period minimum quantity can be lowered to not less than [***] units in which case up to [***] minimum quantity units can transfer to the 6th Period resulting in a minimum quantity of [***] units for the 6th Period.  Any minimum quantity shortfall below [***] units in the 5th Period will carry over and add to the [***] minimum quantity in the 6th Period.

b.               if orders in the 5th Period exceed [***] units, the overage will be applied to the 6th Period orders required to meet the 6th Period minimum quantity of [***] units.

 

***Confidential Treatment Requested

 



EX-21.1 9 a2190933zex-21_1.htm EXHIBIT 21.1

Exhibit 21.1

 

Subsidiaries of Amylin Pharmaceuticals, Inc.

 

All of the following subsidiaries are 100% owned by Amylin Pharmaceuticals, Inc.

 

Name

 

State or Country of
Incorporation or Organization

 

 

 

Amylin Investments LLC

 

Delaware

 

 

 

Amylin Ohio LLC

 

Delaware

 



EX-23.1 10 a2190933zex-23_1.htm EXHIBIT 23.1

Exhibit 23.1

 

Consent of Independent Registered Public Accounting Firm

 

We consent to the incorporation by reference in the Registration Statements on Form S-8 (No.’s 33-45092, 33-47604, 33-85512, 333-2894, 333-2896, 333-51577, 333-82965, 333-39124, 333-61660, 333-108050, 333-115187, 333-121496, 333-126513, 333-134528, 333-145202 and 333-151503) and Form S-3 (No.’s 33-83602, 333-2898, 333-14143, 333-15295, 333-58831, 333-59639, 333-87033, 333-33340, 333-61144, 333-75066, 333-101278, 333-108008, 333-111086, 333-115509, 333-127949, 333-127950, 333-132730, 333-136860, and 333-145200), of our reports dated February 23, 2009, with respect to the consolidated financial statements and schedule of Amylin Pharmaceuticals, Inc., and the effectiveness of internal control over financial reporting of Amylin Pharmaceuticals, Inc. included in this Annual Report (Form 10-K) for the year ended December 31, 2008.

 

 

 

/s/ ERNST & YOUNG LLP

 

 

San Diego, California

 

February  23, 2009

 

 



EX-31.1 11 a2190933zex-31_1.htm EXHIBIT 31.1

Exhibit 31.1

 

CERTIFICATIONS

 

I, Mark G. Foletta, certify that:

 

1.               I have reviewed this annual report on Form 10-K of Amylin Pharmaceuticals, Inc.;

 

2.               Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.               Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.               The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a.               Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; and

 

b.              Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; and

 

c.               Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d.              Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.

 

5.               The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or those performing similar functions):

 

a.               All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b.              Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: February 27, 2009

 

 

 

 

By:

/S/ MARK G. FOLETTA

 

 

Senior Vice President, Finance and Chief Financial Officer

 



EX-31.2 12 a2190933zex-31_2.htm EXHIBIT 31.2

Exhibit 31.2

 

CERTIFICATIONS

 

I, Daniel M. Bradbury, certify that:

 

1.               I have reviewed this annual report on Form 10-K of Amylin Pharmaceuticals, Inc.;

 

2.               Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.               Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.               The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a.               Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; and

 

b.              Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; and

 

c.               Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d.              Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.

 

5.               The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or those performing similar functions):

 

a.               All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b.              Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: February 27, 2009

 

 

 

 

By:

/S/ DANIEL M. BRADBURY

 

 

President and Chief Executive Officer

 



EX-32.1 13 a2190933zex-32_1.htm EXHIBIT 32.1

Exhibit 32.1

 

CERTIFICATION

 

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. § 1350, as adopted), Daniel M. Bradbury, the President and Chief Executive Officer of Amylin Pharmaceuticals, Inc. (the “Company”), and Mark G. Foletta, the Senior Vice President, Finance, and Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:

 

1.             The Company’s Annual Report on Form 10-K for the period ended December 31, 2008, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended; and

 

2.             The information contained in the Periodic Report fairly presents, in all material respects, the financial condition of the Company at the end of the period covered by the Periodic Report and results of operations of the Company for the period covered by the Periodic Report.

 

Dated:  February 27, 2009

 

/s/ DANIEL M. BRADBURY

 

/s/ MARK G. FOLETTA

Daniel M. Bradbury

 

Mark G. Foletta

President and Chief Executive Officer

 

Senior Vice President, Finance and Chief Financial Officer

 



GRAPHIC 14 g965363.jpg G965363.JPG begin 644 g965363.jpg M_]C_X``02D9)1@`!`0$!L`&P``#__@!!1$E32S$P.#I;,#E:04,Q+C`Y6D%# M-#$S,#$N3U544%5473$W,3-?,5]#54U?5$]47U)%5%]+7TQ)3D4N15!3_]L` M0P`!`0$!`0$!`0$!`0$!`0$!`0$!`0$!`0$!`0$!`0$!`0$!`0$!`0$!`0$! M`0$!`0$!`0$!`0$!`0$!`0$!`0$!_\``"P@!Z0*:`0$1`/_$`!\``0`"`@(# M`0$````````````("08'!0H!`@0#"__$`%H0``$#!0`!`04#!PH#`P4+#04$ M!@<``0(#"`D1$A,4(3$5%U$605EA@9G8"A@B,CEQ>)&QMR-RH1E2\"4S<[+1 M)"8H-UB"DIC!PM(G.$-':7=YB).SM;;Q_]H`"`$!```_`+GXP\K'7SG\HTX< MKG4_-@H.RI7=D?-/C9^:3L(]2N>)&P'?:IH]"1/*TA.9/'<[EI&W@0+IV1PR MP"X,@C5RH5^MRMXFT7.N,1\D7S"^2GDM+T$*ZF:W'AB7@7CSE'LO*'(E#.@L M9XJE(&^6BT8GA7IPN-F-Q`9!`27H?0+`4Y&VX&8>.'T)G\FT2MO7%D2.3-'S M#]B/Z/VA'#'EGBR2>HIU[@@CC5LX">7NM8#2\OZW[&[XEI_R%.<%='/T1)[\ MQWLAJ:540:0*YDMUV[=A+:J+;]XQ8&2W&^+7L&2^P8"D0C-P)G!9PYUZ;Z`Y M$F-5'>@J@CYT/_G]YW;*QYLL0<7F"P0&ZA2L.4P"+39G8+7[5R3424:,-..N M5D:]5\RS*_7A%D2=!PM)LEQ[8ID^X_84FLYV/1FXA#GY,&,G.V`AA:9"8"G' M_P"0269!'HQ0F+XC55]2S+'3??M*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I M2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E=?G=X0727[*:$ZN[M67GU!<+262Z M(YTB-_AFZ^GY%,[D%TDD`H_5-KCUJW^;@R.SD@+7>U8M($\D)@CN3MQS;U+= M!I\2?KSIX29EYT8TU1TU_*/TSI"3GB\W6\W4V8G@!AS:8G%RETCC$S6Z>AP# M8VS<_3S?.)MVB[<>;X+MPLSR!!B9IT#=WX:=7A7X*2CHT/J9Y'[CE-Y>0=S] M"<^])-WM!+$46-5$R7OS`QG#&,2!$'.X>UX]+,74P7@Z@SW;9,SZO985P*+E MJ3)#I2;;+.`>*0/",#K(G1R`XI>>SUE*4)VFB874)#-X[*LTS&Z%#J?KV5MM MNXX@FXF6*\T@T.!&Y*-0L*+'I=RX@KQ4KU.%2$D2IO*3R7DG3)]&6_B/O3+= MEIT:M66W+[Z^!<_:V9:\,LD?VH_(O\`@A[T_P!Z>`JL*I2E*4I2 ME*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2O'K;]?\`E?\`]E>:4I2E M*4I2E*4I2E*4I2E*KUDC^U'Y%_P0]Z?[T\!5852E*4I2E*4I2E*4I2E*4I2E M*4I2E::G?H>#>8&#OE/H:5V'#,TC.,>UFUH+G-VQ.(';2Q+9J2ZU M9'=JV:TFG+.V6[+7G;'^K?TC3$OE0\<<\2(UXDAGMOF>3Y->JQ2@:;$8\M-9 MQ.EQ+40U<85IA`<>MVJUNY.+&KU^[#5A>^"5)OVY>F.N]3X][KM\[[,+>OI> MWKEC;ZV];?6_Y[?.O-LL;_2]LO\`E_I?Z>O[/Q_-5777'D,E"".G(XY,@/BR M3>P):?T%/;H10)8DL0O$^AM1\Q9`;$<%URXA-+@:H=?NLX7@`U:T@\MF1SP7 MX;-`]1HT+%"7G^/^[97Z`G>7.W-!HT;4^]3912E*4I2E*4I2E*549 MYS'4_6AXVI7(1I(,A1:[2TN<>LA,]XJ>)U@2`(#R-V-`\?NK4VG>V5B`V#6E MFLY3(?-4@5ZMETZ_=JSMLU;,]>=(3=>O/MYWC\CQWVMY17NYN?/*YQGS;)(^ M?>V)YDZ$ICBN5Y1=C$<#L9C=<3R*-J2XD/.V/Y(C5&YEFC8A7.B.7%9)K5"M MHY<3[EV/SQQ]?^[;_2O:E*4I2E*4I2E*4I2E*4I5>LD?VH_(O^"'O3_>G@*K M"J4I2E*4I2E*4I2E*4I2E*4I2E*4JBS^4!OAJQ1R5SW,DAHR2J+X8\C7`DKR MGM&A-SAVHXZ8T^!C3J49B=6G?@N]Z@T7'ID:C&R=>17(1VS*V2S"UZ)!$R=& M^0J>O'P>9W6_\W25G?V([9!&\W1'XW=@TIQ(R%$%=+IFBZ'IT3-,7:F5,K[; MK2)@8[?X`DBR82IZ2"M7`1I7\CPY=3V.]GC8Z6=&&.4A^8SR.$<\MHE5GJCI M'QC#B79N0Z?=*M-\&?REM5Z4"^WI[:1*M3^Q?VMN_8M57Q48?@D\/;%4Y:OR MY[N\KTF:<;EO?I')Y#IO:J);I,87PW)%B&(5$9I=J1+;^BBT8:]>.K"]]6SW MVG++7E6%U?X&!2?J^.)@A?F<7V1#^GFEY1-(\>=7^2SL5D.Q3))"36@ZFB_$ M$C$=4Y.10%"-<"8"J&*,NVVBN)'=1Y0,N8"H%F>(\F#>NO$3TV\9\\B366:> M(I6C.*>5XSFD7/\`NZBW\-,B.9$D9YQ(Q>E9#6Q#$CZ@6Z-:E&M1+$ MNS:F5HU:;;J4)52?;M3J4^S7OT;-FK9AGE]U*4I2E*4I2E*4JD#S+*$W4S8C M+Q(L%`@/S#W(6&'WJ5W65J=/.7+,+O=K/&4NFBF`U5HVH7(#/CFVRX)2%]B4 M2Z)B,C-6W):B;I=%L@KU?XM.&O&7,/CX[FBF&U`"".?I]C^*NE!16197<@EJ MM&2C"1N0'T@HQ<,@+D0]1SQT61;)9>*0C]S4V@Y6?YK8T\R.O0N3=J?'^K;Y M>GI\O3Y^EKX_*_IZ_.]O6WRO?ZV^=>U*4I2E*4I2E*4I2E*4I2J]9(_M1^1? M\$/>G^]/`56%4I2E*4I2E*4I2E*4I2E*4I2E*4I>_I:]_P`/G\K7O?\`RM\[ M_P!UOG5'3WSR\H'?7W/);[2'"7C5DD(Y)SV^QEN;'2O>P9-I.,&$%>.%_@G! M'?):-:-DR2QRE0H1$9J)L5M%`ZC6TE>S&\''5CCZ>E\_E^.S9>U[W^M[VOE> MU[WO>][^MOK\_K7Z4I7#.%N@7:",-=TA1+D;;A&+@A]OGQJ(R#.!BB;8C)B# M`@CH4CR@LBCV[4B\>N3[TBQ-MV:%&G9JSRQO10102;X32:MP-Q*]IE\1"U_9=0X8Z%I])%SR9Q0.RW)]A]@H]9=]0"/U*W$V<3[-TE M!NF\1B/QF2@S&O(D=ND"]F(]@(MT-!WMK;KSM>U[96RQQRRE*4I2E*4I2E:7Z*GZ+^6(-E+H>:'#BUHOB!F M&7P\C/NKJ56H4'3WV8H12##*VXJ?-+;.>6WI58\^M)IM^8P?LU3\G^$V#TE"$LP#*0RQB.YECQW1J\D-K:?B,F^ M\0BP(04C]V[3OQ1EA^M78D&(:]=U`XLD1+TV6"A-JSQ@IXD)OD"0>8UT%3R2 M^/ZAX=D-Q<<]#*M][ZU+K%G&'B#!E`>4VIM*9:0/&T MR7/?<=NV5:32E*4I2E*4I2E*4I2HV@NQ>57/T$Y>4F]T/#QKI-GCM15RP@.? M[=526'29HG3N*!0ZT:6+HD(XF/5*<>WJ28S2D"*MFLJMR)CKHT:C%>DRW2#C*3XYFAA->4HD?+3DN-WJ M,UF6B^F*?&.AIN07LV[=%EP8\'4JQR]/BIT*$NW+1ORRT*TZA+OQU*=&[5A" M^2/[4?D7_!#WI_O3P%5A5*4I2E*4I2E*4I2E*4I2E*4I2E*K/\E?4DC1`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` M.][_`*[WO>][_GO>]Z\U2W/%]G%7E1@7IE-E]FP5Y&0S>XDZ)RQRRTBPO3[% M3'71Q=*!7*VO?GFK?(3.0>;U2G+:C3YDBD9(]F*C9[J^JZ.U_6UK_C^/RO\` MMM^:_P"-OS5YI2E*4I2E*4I2E*4KHD-=XMMM^78I&S9A]^/]N25V+)TK=$\Q M='\_.UN]`\@;B2>1I;CN3INPB+>S4+H7,B)).><;`WH60- M/=;!PI-*G4**WT;%MNP]X!01E+R1/#ZTM+-!0GYKD M.5\UT;+Q[0.CQ)=M`3^24V?`#U@Y+[\623%D^JZ,BGRSVLB!=""/++!"B:I+ MB5^-HEQSWGOBP5&\-NN+S3/`_?YP[MR'/DZXIIE1&_RMQ.]O(\2X0#'B7%<- M++[AL])A*A$6Z4I2E*4I2E*4I2E*4I2E*4I2E*5@_??5IU[%"C/'!.GU[-^W7KR MJO\`&M&3YGM]R)Y6>BFR1;DG=1MD8U.68N<^FV)WF/AA`LUG(Z92M-Z[,!U_G:]KVO:]K7M>U[6O72Z[\X_F%N>6>;D?#1?HACQ.W^0(Q[LZDX^Y$Z1 ME_F1P=.O>1ICFN(I(?\`%:V/78+:(/H)$V6`VG8B"JFW<1,Y+:REZ.IE7OL-8G(QH MP8:)/2?;:<6[V7LNC6-YS@UH@JEU+1U].GL'TI2E*4I2E5O^2OK!^<]16RXJ MYU1#7+VKUR],8%Y':!/#XD:E?),=N)/&97@FU:U&_3&'/3#TEY3?9')'O0YW M%`FTHSTJ'.CROOWC+E-B<6I(PZSRE0J4>YWD-8U+E@/'H]&J4=*B)WARP+[1Y-FGG185S M;)Q\M6ZF.'RGS4:"$;3$TEZ-XPW)@M2ARU$$Z]@2:!:[HUW0J$ZA1I'*$7OL M-2K;;+$O'!U81[%Y%C&67@*P:\RBL3T4=',/+#6G51YTG#IM9'4Y,U4AUWRN M@UCW^!++P^G/++WS<*!5VK9MT*]6W.=%*4I2E*4I2E*4I2E<5@##:RZAP:Q0 M_`ZJ')`ZDS@DT8E%`E`K6KT(SUZ\^S;T]/G]?7U]K+U_9?U];?W M6O:WSO\`C?U\VM:UO2WZ[_.][W^?Z[^M_P#QZ?2J]I(_M1^1?\$/>G^]/`56 M%4I2E*4I2E*4I2E*4I2E*4I2E*7O:UKWO>UK6MZWO?Y6M:WUO>_YK6JCOIC9 ML\F/:J+@@+?8OXWX_,L*8O(21QO[;=F>6-^&MY<\\5>^ME;26$"U2(7.W0@[ M#6N0V!H(]897)*J<1!-:\'7ACKPQPPM:V.&-L<;6M;&UK6MZ6M;&UK8XVM:U MK6QQM;'&UK8XVMC:UK>]*4I2E*@CT=XT>+>LI0033.L1DG-*8YC"XU3/5O2U M-L8F,F*%/&G0);2O**I(9"8B/'.%Q&2Z2Q!.JWZ5J[9MQW?\/1;55JUH!B7P M2]>+Y1BYHZ&;XY>^#T51=,RO>6.F_P":5U.'W&&_$LDN)X.LJ;/9P-/JMUKF M<\BCI++-W MK7FE*4I2E*QQV.UML9KN1ZO`T/;329X$PZ72XS6_%`&;[<;XY27.'"RY1?7H M1C!`M&K(+U6[9AKT)4^W9EE:V-4_^.5INCKJ8Y!\M(TAC`PCDU4'5:T^8B2^O7`E1RJZMBA+M*"8Y1QJTM9/)#H6IKW1TI7 MB]K7M>U_G:]KVO;]5_K5+;.Q_F1>6YY1_P"QB,Y_\K;7(S$R,->-M(IM]X\^ MM0<*F1OI4J:^M(@43]SZ/;,DY*5U_BCSNBAU[$N&U3O5YYW2_7Z4I2E*4I2E M*4I2E*4I2E5ZR1_:C\B_X(>]/]Z>`JL*I2E*4I2E*4I2E*4I2E*4I2E*QYU. MYJL4"O=+U!C[*U6E$ENN+F%2([;KPRK+[F\E$?1##PYN\M/Z(YPZ\Z`>P'GSE",F](C/\N]G8I5JD:94K5W`MM.!:Z/ M=8<#1Z\)@TI2E*4I2M[1.:;[AAYN'T6U` M20;_`&,L-Z?//3M]ZD7)-NA>-7:DQ$>H3KDB;?KJS\?4L2-S7+!WQ4=3.TH[ MY`BAF[GWQC/#IW>VOZJY`%K=08@0*%2T@L7;]F MG0B2(D^K8H4+-^W5I3:M>6W9LPQQOE;^>/SES@4\D7!<0$FLXO($1:K,YOF* M6/(MU+)'474*6%).=C,8TEJV]RG!S!D.053%E`JYW>E;"R9W8UF*NCA@,QO8 MA@SE6O1P[D23O&^.XBN+\`\.%BBG8U*4JN'RH# M0ZMY-)[=7O?9%,KSQT9YY8R M7Y+Z08O7W-4)=-1OGG9GS5';_P1T&02Y7OEIO4AZ4I2E*4I2E*4I2E*4I5>LD?VH_(O^"'O3_>G@*K M"J4I2E*4I2E*4I2E*4I2E*4I2J+?Y1^[6&SO$G.961\Q6YIXROR!N-`RFH:N M_*H&%Z[A)TNQM(093?H3N9619+?/F6 M>B^5NU(L1^/:#YOEKR,%U1UTM#;$?0T3NDI#W4\`DU6.\[""?/:/><>'01I+OR49+]"60: M">.LFNT''@\)9Z#DW#?KA7E2#6_LD/H>8%>BV[WV]KL1!NU7#-$=9,IWN&2G MJM;4>-M*D5;"CCP4Z]2+?#`;PYTQY!B""0?*>=2LJ#\5Z(VR_&)"CT5K(D3Z MDF[$@+W]E3"#^R2O4+O1K,42E5'+>_)WGP*0$)\+"7]K4+5>_9U_!9XF_A;H M,.)HITCKZ-Z3$8F6O]**U(U5]MU"%.+3/74/2H=M]^_VT*9-J27]]MM;3:VS M*U[1&8SVS'K0:K!989$W&S/6B%BD*1 M"EPSV;,\=&C7CEGE>U\KY+2E*\96]JU[?W7M?TM?TO:_K:_I?Y>MKVM>WK^> MU4N\6VOQKW_UKP&1SN.B6>=AKR%\9ZM^W=9`A02(X](;L:%PFW=JTH=64>SF MK02Z(;@W;NW(&G-][ZDF@>)V;+71TI2E*4I2E*4I2E*4I2J]9(_M1^1?\$/> MG^]/`56%4I2E*4I2E*4I2E*4I2E*4I2HI=A]EPGQ!$V6AJ15$+#'Y6*O5_.93CE@@%([:T@]'J5G#ZX2`'$"::#W-W M&R8O/O)NI:3=[.W9Z]!=Z15 MD\HUS,8:L&\CM;1&K(=X!1\4&JT*->.S#7NTWSRT*->I1JVZL,XI7C+*V-O6_P"../[OZJHMQ\],,$&L[)&:O#ODU?,0LXW)(4I-C0Y:!$X>V8Q*['&R7Z932"HEM M"!Q`-]PM,^B7E%RA#K1[!RC4NP2JM6U/KX5F^0+K#RFM1K7\8<;N;G/GEYA$ MRIY>03JZ.M:!4W?C=&NY!MMTN)C(G/(,XR;=.IFSI^9W$ID?HJ:RFC'3[*A^R.6UXJM M871LT:]@AA-1(VHZ;M\;?8+40;,MNW;-^E*4I2E4N^;'-+"L&Q)Y#&V5;867 M_'?,0:;6KI.N,,U%$HQ*Z$]V-TUSP)+'"0],J*2W#BXN1;+<28KBKAD)A,A& M+'JUV.G3E.N).]>)IT7,P)$?6G.4@.A_CD)-HLMM33')1_&DZ\+^4.G1H8R= MQYNW$IH#6V+B(K:&P)#<$RRRY*GND46URW^OTI2E*4I2E*4I2E*4I2J]9(_M M1^1?\$/>G^]/`56%4I2E*4I2E*4I2E*4I2E*4I4+>T^WXSXR9K:VFA9R3IME MHSO9'-W-<>63KI=Z#DN^K7DG:C*%[?:U#@HKXA.2?TAG+)F;'+:]^>^#`.1^VCS?(A&"R6\MWEH,XCCEPVQNMB3GM$NPO\<\B MR&VE+,<\+,;NF1B%E8D-N$,;7J0%+6K6M:WI:WI:WRM:WTM;\*4I2E*4I2E* M4KUSPQV8989VM?'*U\U[7O:^.5KXY6O?'*U\;WM?J M"*>\9+\0O?O0OC^YWYDVSURN]I!@]Z0"**\'"%%)[`X3_E!G*JW=,;-[(R9')L[ M1)+(^+=<$,B8AW:C]?F1*/VL^]#@8PWF-EN0NY42?8YLVL5U``1C0&=`0R#* M$4AD]CLJ<&<'-9?CIWZ4L8L*4. MV9F$6RSTY9:=CODLC`<.I2.K&VW&VS3&SM':=V&&[T)ZLLDU45.'IJ*8T M;\8=I<`^1;NP3;QZ%Y8SD!./5,'7&@_H`0I?&;Z3EM*@3N9UFYK(V MS#+K];^H^?P M;`/N!]<:R;SAV>150?+TG-<1@Y<9+YYD(X!::T4YR^29Y1[MCAS#4V.0?/&N M^;K_`/-Z_P#DQ_\`5M7O2E*4I2E*4I2E*4I2J]9(_M1^1?\`!#WI_O3P%5A5 M*4I2E*4I2E*4I2E*4I2E?,LW9ITJG?KMCELTI]^W"V?K[%\]>K//&V7LWME[ M-\L;6R]+VOZ>OI\ZZ.EP M*DZ[:[I7UZ>G MM7MZY>G_`#7^?_6O:O'I;\+?Y6KS2E*4I2E*_+=HT* M1:+N>"9\:%MF]FOL=ACAC8H!59Y;6W(335>V.>3#+'`*O#'=N1*DG`>/3LLK MU5';R9TO-1+%/87,SITP[U]"FI1GNU,J44H_6M'/!G[-]_B#$,S(!OID.'77 MJR5H"[8([!6)%85;Q:^%@M*4I2E*4I2E*4KK1Q%Y,.PC?ELD'E64GYS_`!:W M[3.<8;,XYF>/7G$#Z`(&2IE#\HRY1L.$B@&!V_9MIEBUKC\UVP?D46ZN;?EF[">[0:$',?H> M&3_6]RLEHIB,-:]QE ME-\SCDMV&]VA5KR&I;E/%-UM*W64`2=G/&AJ;9MYIZIZ)X]E1S,40J;C-?[L MY^>UFYC(#=;"TH<4-E*[`BX.06@OMDDG'F;DM:#?@@R2ID^%Z.AX%FSRQP&V M8=FB+)3<45<;]Y@)-`QZ_6P\#$>G,IYX:$XAWH-`$UZMLD\B;>.C\4)G4C4W M6!R:>VJ^U"HQUVV4I2E*4I2E*4I2E*4I2E*5\ZO5?>E4:;96PRW:=NG'*]KY M6QRW:\M6-[VM>WK:V6=KWMZV]?QM]:Z7OB[\;/7\DQQ-SMAWM>#QD/,N/)6\ M3G.LEOOBHV^B4DMLCNHNF^+4^Z]]GN:E*4I2E*4I2E*4I2E*4I2E*4I2E*547Y` M8&E.*Y(9_DSX^:BQT=`P4V=S6Z&@\!?'3O[/Y&T*MIMT17@GOEAIW39%6_)9 M(W.)^]LUGY1:#4=*=:\,]K(T]B?/\\Q9T_"\;=`0FZT3VBN6&H->++.B(I?/D0S@I M>ZWS#[[PC=[PN?Y\CD;'K(.0Z[FPB0'Q^Y8G$I"+H0N)<:'.#7M)-Y8GNVRJ MT=LB!M\%+;/"WU),@=C]"/KN1W=!0'TN'[<7-F&1+U8DC\Q,\S'<,(&S$@AC MZ(@VL$2QW(Y0CL99L"30OK:?7DCJC)3J08);(>$^+F7PI!>R(&L[W7)1]S2+ M(TSRS*[ZUA$[QE>8Y<67];+*][$J4I2E*4I2E*4I2E*4I2E*K3\L/0KV@KD,^VH8663],]2/ M!G\?>G-,E%L)5L47QPO: M]Y;XTXEN ME6?-JK7ODL+$UJK9EEGNRO?>U*4I2E*4I2E*4I2E*4I2E*4I7KEGCA;URO:W MK>UK6O>UKY97^5L][6J!7)7D5Y_[)FCKV#XF)[U#IY`E1 M)&SHWJMR6Z%[(=R-0,6/QE;-67_E-HC9.;4EQ0K7Z;J-6+ICLKG[^R8B.QRG MMZVO>]K7MZV^MO7YV_OM^:O-*6O:_KZ?FOZ?MKQE:V5KVO\`2_\`G:_UM>U_ MK:]K^E[7M\[7M:]OG:J+79>_B+ZN(2?H]D9XSNWI1&Z)608_\%M\2=FR$3T" MQLNZ+V]=#:YVZF.[D`*2\=NO2WHWF]0'>-U@D&^2^C&]*U_6WK]/U7^MKVOZ M7M?T];?*_P`OE>]OPO>U>:4I2E*4I2E*4I2E5ZR1_:C\B_X(>]/]Z>`JL*I2 ME*4I2E*4I2E*4I2E*4O>UK7O?Y6M;UO?\+6JF$/GM[*\P1LW>WVA!7BCC;8T M0FW'+;<8=[LZG:Z8@\%FK9JOL&&%,$5[6M>_I:][VMZWO]+?/\]_PJH&4_ M+?%\8^4N(/'4N$I-XQ\--"!?,KYD;:$3`Z1E`47?'.T(KDFS/#VBLDQO'T@& ME.6*??FC)GHJ0^_37<_N]\A^H.^V_P`VOP5%(;F7M+I>33371NY$V>9N;W4^ MP"4.27DQ:#:X)@UE.Q<(6X*!IZ1TA9#HP3JE@[5I(C,EN<!^[-*^9MB:5'T^D!'44S,K7*UXA5.`!'&X)DF%8Z1JA\.= M44^T]ULKCLQNW7OK6\GO,/E9=D8])OSE/MR=S+C+Z$"+F;E#G!CD)9S<+X=8=JZ]AYXF=;9V)2YLDI4M<+P>`YHC>LY!VL][1]-ZM- M/`9K1HVF\WCN\@_Q^](I.G4^Y=?M/_*7;3XE0_)'//DTDOGX"<^Q,M4*N7FO MF^=8@"9B!`D6IL$_*!M-&5TFL]O0+C!7#=*BF_VF:5YHKHTJ="D3R$Y=9W5C M'9IP'UE-L2SX[M;BMFU7S%,'F8$T[6G8.,T_#.IH$I2E5!O<>1O456YD`18: M+L@5)$>`S':GRW[*].N?(UV]Q6#FV8Y9\<#;=/*D/8.1RJYFBSN**][MV1P' M(Y)Q;@.1)*<>18K1.8XDW#L<&.TG>]B>1M=BW@"QR$,Q^1"OWPD>0+K%5UUT MAQ)Y'PTKQ[/U[>MKV^=KVO]+VO^>UZP&4XNC^;( MY>\22JT@S[C>1VN:9CW9[@3_`!0=QMEP(=PXL)7ZK7QV6U*DN_/'#?HV:E23 M?;2L1[M"M/HW:ZIN#I1D#DR9M_BGZ@=I=W&FTUC;ZX#GMW*;;2G2W*[8WZ$Z MJ.'08S]E.7Z-Y92*AC5D/1AEI+OJ-KM*5=8S+#8Y5N-RULL;_3+&_P#=>U_] M*\TI2E*4I2E*4I2E5ZR1_:C\B_X(>]/]Z>`JL*I2E*4I2E*4I2E*4I2E*5&_ MK_I-G<>\PSITX_;>^;4*1NY'UN%X;[)U3F+C$>6MK,L7MRPSQN!T M7QRNI,'$6C&U\MEK5'[Q:\U//F;CMBBI@M@HZ2F8T[.F^K3%]6&M27Z3Z",[ M9$D_0HOKRRU[4[,5E!\:`LL+Y6U-AD!4UL]EM/O,K$:4I2E*4I2E*4I2E*PY M_2$Q8L:A1]22[VVPV8$R'XEW4[3"``WQF18JA!C,5Q8GO3HDN1`R3'"T6.[= MA=207)4FFV>_?KPRS"U[7^=K^OSO;]MKWM>W[+VO:_Z[5YI6FWIT'#4=RS#D M%O60`3>EKH'%_P"<.,=?L48F7]:+@*1S/S[$PUI]B?*[=!KDI!7BIWI\MVK9 M?!'93NU[=>'T3A/D*"D,>4`!U)*[):'*G+/6(89.C MKT[%2B!N:VXW;HR&>PRUCT\JF"_IB48$4R)#@BB^/CB!3H(X$4QSMS#8+ZETLJL*4-$?MZ".,Q]OJ(@8K- M"5'%E$:ADYTFG<'QVLHD4A4>&_K2,7P4]SM/E^5(H,\W^-]Z=2RL9-/I9Y!W M7USTPYNIVA**9_II$B5X-%\N_CUSO="EAPJWV*A0`L9'U6?B)IJ=CP*;5#H* MWU=O&&,97O$D;8SUI9>N:L&.V-,L8QV0)%6!ND/2(2ZG>K9BPR%;Q7:V5QW6 MM7!,284>O3CU.A*J3X[=&66>SK6M;Y6MZ6_"U/2U_K;UKQZ6_"W^5J\TJ)': M7&<6]V0\EA"8CLF!&4F?K*D?.\6OI9'YM8XX\)Y.!G?'F$*-;N5#0;HU"G6E M'9ZK:;.0``*97OM%Z,;UY2KX%N:IR6,8I,73OD8DDW%KAW/"*W"\.UY&-GXP M>FW1KT8O%@%UB#-:V''H]PEW:EX[=JMLW(TF2G4HQT886L+4R*SN$>66\YNO MNFE3D;L8(FJU'WTI+8@*VUAQ:Y'4B:39<#\TL((F;8?DW:E2):DW;DJM/MU[T^W9JSQSO0!_*"8?=LYM+QJQA&DIN.!94??DN8#1CN M=61;/0]HM20["X'!6ARV^W?1EKK]X. MDB5HR\A?`?/,J]/^1Q/U,6MTVV.S.3.N)X%Y[]_<2M>U[>MK^MK_.U[?2]OQI2E*4I M2E*4I2E*KUDC^U'Y%_P0]Z?[T\!5852E*4I2E*4I2E*4I2E*4JE_NB^/7/>' M%7CW'[MBN/XT(H_(QU\DT[_I;Y?._K>_\`?7FE*4I2O%[V MM:][_F_;?^ZUOSWO]+6^M[_*M"P3T[!G2_WL?]K6O>] M_2UOG>]_I:WXWI7IELPPM>^65K>S;UR_/?&W_>R]/ZN/Y[Y9>F-K?.][6K5T MU2R,A&*GG+)1I26_QK+#V+[F?#4>N26),<=MBM*BT#F;'[/2+G`YRF_>LTY6 M2C]%\-"3%216;DPY&K5:>H9Y!^S'%Y2>A&/XV9Y9<<^-_E%H[XWZ?ZA5]V]* MQO&\IS)$I`HK$QY$NF-8ND#8ICF1]J_(G,()EN*3U)=(K9L?NE_C`C:VC@+Y MM$\>?1?3'9'&^N&H.[%Y^#]4<0S`5YGZ$F8Y%Z7K%C3BTV*'6)(GF-JI&5.\ M7Z-&F=6!M94A['?@ZRZ74ZT$AL[<$UDQJS8+L`AJ(O)&V9*;!N<>U.9Y6BQ% MN(W=C!8W#3IB-UG]&\0O3#<0\AK>NY)2-W'0F]+O'N#F5KS]D\%JU2,V!5R=&_H<=#/>W8[CZ'ZTF'R^-IF=8;K%\_%3AEJR"(/-]4Z]$%ZNCWV;>*#9B%R+&7BRTD8D'H82AT>;,3 M=\SD>9(Q[:Y%YZGH&C44%N+43%Z4UWLPGP M)*"UQ=(AT8XGQ.XJ(V:].U+MJ75L,;7]?3UO;U],KWOEE;U^MK997O>UOU6O MZ?JKVI2E*4I2E<2>`A'2$+MIRB!;@;I\8N"G01L>D+!C0%ZW.:^!G;Q3...GEN9-S>X2=:1UDW9QE M(2$T^`L/OQ?KS6BC?([V4'-)>(F,;.[MJQYPX>Q=D>(,MR]9'8QIJ"5M`_>7 M2'-_*'>(]#%$P[?R]6<]RPV9'T#HVFQ]QK(412WI9AI.U3"QQ0H^V>_V8X-S M'?912+1+RH[)>&/:BFE+OT;$BK&&+Y\#OCOD+,09*@^F,GXS-!?**I35=S=D MNV0X5<.-+!?M;."7"UT6[IB*Q M2J-B>=ABE_M9CDR2Y?C<^T'@U)`;`!ZL9R@7BSW4(0GVPZFL8'N!N.(&43X* MQID$<$J%8PN*7I=NM0C((%2A*ITYX[-6W+&]?(_G\RXL9#MDF1G0$9+"8C=+ MNUY.YRD$XD`VFT!1;B)DV8)*L]:=$.&H=&Y4K4[<[8:M6O+*_K?TM?*$RE.L M3Z%:3?J4I56G4H3*-&S#;IWZ-^O';IW:=NN^6&S5MU9X;->S#++'/#+'+&]\ M;VO?]J4I2E*4I2E*KUDC^U'Y%_P0]Z?[T\!5852E*4I2E*4I2E*4I2E*5Q1T MV);84LX3Y)$%!`AB\P:,$E.I&.$B!:7]JB/$*&*S$V.A?)4]QRQ$[O(M*_WC1HC*I]J0JU.,8M2JXYX^:& MY'MRSUHL3+!2EYI7ZDGN-:@W,!!6K2ZB&:GUN,K41;H""@$D"X<.3/$X:7#F MO5N"186D=F#9',:-^.O+3O%,9:;T.DAJVX[=66O-(*W6VVV:[Z_;MGA?+;OU MI2][6M>][VM:UO6][_*UK6^M[W_-:U<`'=39<*YR#`+A"&B+.-X-IVH111"0 M6-AQ;`HAR:P+@3)-^[<&,YMYP`CN`LC@F79!S0HG;1\$12;]WY.UY-)@M\F[ M'RYV\S6L%39K##E=9H8W&^*2:\;Y;%1(V95(1:%/KPQRSV;E2K5KPQM?++*U MK>M:(Y[[-Y6ZQ52*GYGGN,IVTQ0<#-M^%XM"69=A3"*@/4[<> MHD_572B9`^W,O9(B:]'-\%-8@(AU"VR*!7NWB)==+F=J0WF$![(Y(&2*<9MJ M_P#%WT)$_BK[BYW8L4]9RQ*T+=P/S[@NH&GV)RP_>/C@![-(015QCTQ&KD>: M+!ON<>3>+D-M=Z['.>W/[6,.B!\@Z%B])T?JUE]H22H_!;@J51C@M M([=FA7=/8E#,T13T/�FB$'\V)0BM^C]Y1GOMFD]1ANGT25>K%+-B!=IM:V M>Q`5'KQ1%-MPU*AY-"L'K=&A8EWZ=>P2),<('KBQ5>B&BQ:14O)$2"K0B0CT M*+1L5+5BY6IV:DZ1(D3:MJA4I4;->E/HU[-V[/#7AEE;]$*Y$31)"0U6E(#R M"5.M0KD2C4K1K4:O3@H2JTBK1GLT*4RG1LU[M&_3LSU;M6>&S7GEAECE?Z/; MPOZ^F5LO3ZVQ_IWM^S'UO_TK%7R_6/&+1/R!)+R:L>L1J#=QET/1\.$0TFFV MQ":^%E!0^XCZP>'##M%]F%MRTBL3)M5\\+;-N-\K6OUV/)AYU>=[04XX*\;_ M`$B`GKM*938N+(U5*&+@1-H0#;V.`N MJ<*YN[,Q&\3@14:+,/%9W"X^^>31$KO^*G9"4QL-WN&!YYCEYIQ8\LWIUBA" M#$RGIT@$I1>=;(F[K6K?LEOOE$WWDB18:\R(7%`H&%">EE?B=<$]YJ]_D+[D MZ@[##$,EZ=;!K2/X?F@IIPV M67(\]:C;IRMA8K':,9,AH1NP6^,:;%8#7`LMFM<-H^$$-QJ-<6E"-\$+36RR M^''"1*)(@1Z?;R]TFT:\+Y9>GK>J#N3J3A^&)X!0\XN*WCW!UL^61C*2Z(N= MN68]G26PL6(5F321R9([B>VQL-EHM#<1$Y-<"K<[UT$"RY#H$A1JC'X3'.27 MCYG+C[HR*W')7)DI!8TBWWDV= M9O%9@@7[""3)"9P)!EZI&0RWYSXI7K[-OQR_^GG_`/BKVM;T^7^M[W_ZW^=* M4I2HX=;]2Q=Q=SI*G34P[R_Y!Q0!T%2(YM#\2[I!FCW9X[W;QG%_4C^"Q%" MTP:>AHXGE('F-XZ%BF.HIGYILQO@2D.NZ0L4.0YN[-"QY`L',L1-DF31K\2> MP9=C:_K:U_Q_'Y7_`&V_-?\`&WYJ\TI2E42^7R%6#SXQGIY,X!=;IYX[O8B% MG,IAN>(PR$S?L)WNMS@F/%7+D^1!MW(0L^`)"=)0&TP1%==-(D9Z;Z72SW8+ M0MC-#GIKQ'NKMWD9Q2EP!W0K$/;I"1(\?'=G.!PL_-J]K/XP\G:4T=,PO]XJ M-O;$2.T?SL6"2$C1B@!XNW(UG-)LS0ED[5RV*YH*92\S#I4+!_\`,8\>[=!K M!NW5M3/7OB8W/HW^\38Z5@U=9M\1WQ6)R%]NW7[K(3BENDMLTK,]GMV]O23E MX&ZUXV$%IP\496)XU=3F;^QT3!XUI&,N1P<*O.4"2"Q%S'>=3FBS'=4[,X0[UE_F_DUH2&MNZNP MXLV\3]S#)#AO"*%8QWM/GR450Z9U2N7(]Z'=:`>E5//GTP.&K(W2:G&DD$8F M+XA"%ZG\F7\GZOL7GQQ\@N7(K)CVX2;K686[I@+GNT1Q,49+2IT)#)),(?7Y M,3$(>&MGMW(.4T.=A>X7)FIF:)GTITG<-GV@?:MZ^GKZ7^?RO:]O7T^OIZVM M[5K?GO;UM:O-*4I2E*4I2J]9(_M1^1?\$/>G^]/`56%4K7TIRU%L&L4Y*$T2 M.QHEC9L8H,G&_P"276#9+,`8E"2,,-R,N9QK1P89BO+$$(Q'DL6:;*5ZQ*DT MWSW[]6&47V+Y-?')*#Q;4>1KWOQI(+^>9E$WFBR63TS#3J=KH/$MMM(\*WFZ M#>*XN8*+=U[:DJ`>D4*=^R]L->O+*]K5.'Z_2E*4I2E*7OZ?6NJ]Y^/-C._! MT@-CE[E(A!+$E8W&3"E!URQ/JC4N'"1\KRJ6BE@M2/FFH(#QVXXFW-5Z2)(K M[>6@JR&`P&SC@K%K3KB#Z[2A\"'EIDOR:Q-)0F=0T9ZICA<%"[K*O6'LB21@ M/QE3@%=^]N;][:,+RQ!DR,S71'3Z8\DMC(JL$9&`R1PMC/!N'1VNU_\`:]KV MM>U[7M?YVO:_K:]OQM>WUKS2E*4JH#S!NQR/R+(:\?$9E%@R4/)3+*?G4D2# MJ]*8XS.8`PO:^^R9+28[]>S5LT`X,%%F*GV96M[#GDQL:<,K*%&C#.UYHM5N M,5JMIDL\,A;C2:``,UVNWA>BR48!;C>&I@X,*.38WOBG0BQ:-(A2Z,;^SJT: M,,,?E:U:OZ$Z(A;F*-2DI3M*[#AYEHU20-H=<@FTX@>.>QN"8_+=/KF'TNWYBZ MG>HK3(?><@^5QRK'N[(,+*!+L6;IR7*%J=QZU/N$JJ_>_2Q5CY-CQJ&H MT8:!#$R*;GSU%)_G^*'ESBXG?+S*CX-KT[QAU[JX:+.@Z MJUMU4!;UM>\OKA;YF?(EY4.6...RY%CGC6.X.9$=;-C+9?6!'KEF/9X6!.V2 M&W';4E)A0&-B3+=D>,#7+@N0@7H\PJYD%_?$=Z%T8`TZ8UU4N1E/F,\>787( M,EAI;C0B:[8F]C0=)C==O;H7I]G='R[+>XE]GRMT,TV)(;\8*_I<6Y@^L.]^78N6)8] M943!QRW9KC5LQ9UTYNG8M_*K:ZRY4\JGD=DQ:@U!&[NSL)&WT;IZIO%[Q MNH>W.TFO&.S,D2+RRU8Z;<-N-ZOQZ9@VR2C%38DWI"31&V#37@A'*&\[:[A+ MOL1%@LPO,6T;K9Z$P\8D1;AD/B/DJ489E+GQV<]Q3>'YILOVR6RFXS0S(0N@ MH2-6.ATX:G8.>:%VC6#0<\=,O3WM-[OZS;\41P\]25,YV'DVZQL-L(81(40]6OWB2 M;GS&Z+H,3^"90KUJ,]/^/]]PE%<21OXT>B"'%3>A]T/9P)HJ`F1F;?18V$8F3:GJ"Y=39$CRIFC6LS MG[O(DQ>!AMO#>:Q]UJZK?DNZJ"PIS9"T*C69P*\-`"86BT7YJ7LL.D(1` M>2O9E(2=C\7X+3J918_IW+);[?$IH?BS8IZ8\B'DMZ*U%->_259ROI[^;C&I M+7OU98JDMF-R&SX%U[T6W1:_O4*TP2U:KWVYZ;:,?9QURK+33P5&G/#D:[QF MWGC#G6"F2SV"_OO*F!FOQJL]I:=J)B,X-*!Q\NAT*URHR20(VZBWOY>1..QQ M863;5!<]NV>\ZKG;W548O7RO\V/OC/R%."!HB`>/UQX-Z1>;.3`O<+65@'CT M*19Y2->9HH8D+24C;;Y=;QC%5KF65CR7`2'%`F>Q$65LKK`Q'8GBEZ:Z@@SL M3R)M8K&'''T> M:<\B/4C^1V*QH$DT"-F(D*4"&N^-V`1R(C'/A<[;YC[)7 M`O!`]C;Q3K+I!RS-9HR04Q=D^,SMB..L\>GV.:[5[I:4N3,?3$D4R)'Z\`Z,A*1@M;&/(E&TVR;V',DTLV`M74$H-IX33P\K9S;Z-))F+%\--B$XKP/]5CG,TBN MSH14$::1PRP^P(YXL5V'EBPA8+N*D5RG1-EN],]T1+&TRO#K7B-"ZU46V9^] MG:>!I14=$.>;T#D/+&LX=#6.!`"62B4,(R:CWUL5-JW;3>S5;3L MMC;!'DCL:66$SI1C9T!WI'D@-8(]F6\6^KQ7@'*U'(-3F`9T20PM;2I'DAJM M.K3[?7'+W>SV=F&O9ALPP]W?(T?Q\"R<[[?#/93;Q6:1V1]VN<$V@F*]3;+) M.BR+&B"$?97OMAG?2FNIMOVVQROKUY6QO>VD7MVYQM&SB83/D'J_FUD/"5!@ M(S=2(5N5*;7U MVZOL:^6HU\9+K;4I.CI-[\\PMO/E7,5E.?6VY MDK-A^<'2F:.K^7$W0_(_CVZ`=1 M(]E$:U@-KH]VQURTT)+9\G->[G)24QWZ:(/\R:CID:,T:14HGJN=R)U[%CA8D:24 M;>4+L]`S#;-UIPMW88C-8YA9Q0L*H42A+I2:+QN[*\0"GLN.>LFC(_<771_? MT(")HHW:+G=C/M`G.I@9)36E:+BS%AQ@,QA8GU\>N%E@@J9S/5TN%]+FIO.I M[.5*;*7,ZJL.9_`1.J7ISF:0IJC7A[F.-.9Y'8TSOE5Q-)76CC98T=22+(EBN"EO-UT)P:_CL;@G:%W,E,):$-C'" MH0E$Y\L-R)(]HW-A_DKYL;I[GR-^CR3@XZG3I(#L*1["O2XY.SSJDQJ=ZYC8 M,C[Q`*USP>0?I4\CT9-QDB)06NMPBC`$F.!YXED^BT_=RE.FT[E*C=KT)T^O M9NW[]^5M.G3JTXY9[=NW=MOAKUZ]6&&6>W9GG;#7ACEGGECCC>]M4Q=T#!$W MY&\(8FF)96NZ,W9I&R]Q*JVS'+"^A?9/L]NU\/9 M]JU[5MVE1>ZIXRYO[7:338O3$>[I(:S%>X^2FD+UO:1&3]AOT0-)"0[K2+HZ M=K1)W-!D)@G@'5[ENW(5O6;EJ"R=;["C"/<1^(W@ ?C^>HVA4^*ER+%!U5 M'ST-3QT:^%S5V.@&K;3EUC$+]EUSA[)7`!6[Q9M%O&[T91+9/BLT;LT://19 M+:WI:UK?2UO2WY_I^N_SO^VE=43RE\OMM\>4PW-,H'$1+#2#8U;06*K0QW$`T.)HO5$9:KQ;!/[!-C,M"E-NU> MWAZZ8?3-[HZ8:_>,K9=CI@L>94ZTJ[,RK8'VDWDNA(/M7FOQY2RVY3>W3WCZZG?'-TY MOUQ9O62XFE->YYWXLGUQ9)DR=7MD.%7"?Q.Q8X#*46&#[)'YY=3`-"QR/VE# M=<>?_`O-Z-I+?K9YX%2=V8CB"!'LV&R9,S5FWI0R/PPS-+?7DM*IS(I+>H1B M[$[37`T:-S[MKF%C-K9U$=H8FN(;1>TLLB-VUY#\G_CZ?XR:LS0 MM(33DZ*WN,S,-5^,PTD-MHT@TJ%"15M2$DN>6NVU`M2*QY-)OMI6BR*-6/(I MDJU*HT:Z8Y#\FGCG4>23F)XZ>\./MK0;'&W;`!QNO7T=$F3:`GW-,'%*UN`# M!ZSL^RAIP\B93M6B`ZM7I)$43;-JTB7:G&J=N%XXQY-,TU1KZ#N4"591D`@= M0AWCRR!6UR;9*#])8:X$!_3OR$J@I`6H3D4134KR1*4._2JT[L]&S#.]>$G> M87QV1LY]D>C^CF_-LK>PKPT0]RJWGCUE*NT@DQSOF*5,KG5OR01!+\LM=\/9 M=&8)/I]<=BI2GT7ONM0]YS_(_.4L>."9;`/'5,D8PL,=_-KT=D@]BR%"$*.W M'4R^HH:=3=$H^5T+TD&;RPA]'!8AO%-K\$1GH#MLTN/*K*/@,A:FJJ=?(V\7 M$^N*][2E'P,.LQEW)S4_B]^>&?,L,J^=WBVG7]MMM-*4S%1AE.X>=U*U59M2 M;*[=;FU8'(;[*-`;(-N]4W9G`^7'JX,WPSN=W&W+4Q1H1,FFREEWCSRL\G/] MJ&W"W$Z)6>!@1W0>KG&Q`^$2D$VXLWD3I(E4.G.W6N0 M8Y+$V.:?'+.T3^\OY2YP]SUS2?EKEV38FZ4F("_62TE?/;J=+TA*140UPDER M%Q&RC,>#!T2,BNS]:/'>7169F[:CQWZ?C[)??);**_?&C_*C)Y[([BY[Y$E3 MDJ(V4-Z9=CA*-9\,F<]CI7,F.UC(=CO9XM!F\'\[CKI+`6A&L8M7>6#H#3V=A70FL1+)$0M`4VZR%T$;&!YON1 M];3E[+JD?)'$DR\_O=@1U+W/,Y-C>X910NF5PI4_%]XX'PY:1,)F"R(.`G-C M07Q[I)KUV8A3BN##,5`O:1VI,'D*>D?K(??H?FU6`Y#=+.C^4)H[&ZBF-B\C MQQ![`>JU1K5"E<;R2D7SD=F8.AT:=EXP/1\P42@F6"A]SR2*EV66C2\'@9]\ MAL"]&R#M\A#HW0;THSWNP.;=_/O+3L)/;[G/6G&-F3R8WVO;["?&&E[2*N/ZC3S3(=RIU/4_DM M5VB^%#Q]OTK'OE!Y_P"%?)E(,;N-P)^,7S_.2"P$.9$P@Y).,[HW&18&FQBN MI[.UUL0LQG'O5A'P*`N5LR:`>PM&Y1KATBMJH"X[BH[E7S-<<]*0[RU++K!= MKQH\0+04K.C9HY]-Q"UE9!$UL3>WN4N8X_8,LSK.+(CR*Y.1CDF6.#%YD/ MO6OD`/+M=O`2`T:JWZ'8Y"@AJ^]MH1YFL5BM'HWZ3F'RF\:P^].,F@IEYG/A M/W)*:V,(>>$6EWDW*",+1=VDO?!1AQBD(H%*J^3QD-N:,\, M46LFI26(;5&G1K][OVZ].OZ7SW;,-6-K^E[^E\MF6.-KVM:_K:]_6WI?\+UJ MU)/$(KG<.C]',$6*WV7ROB*9::1&:H=A+*R7>NOB@;>DWL-+R9#M MO9*GWJ/_`#.G9GCI;JKOOCWB.S,QZGGIE0XID7$_DPQKC^VUIIX6:VI!M<&+ M;!-P.<,&-@K$H,P4Z42';MMO)($VO#-0L3:MG7MZ2_E!R!9VSSL>Y,V/^2/' MW!.:/^?_`":KHZEZF[:ZN[LY$CR$9E0<_FMGC1Y=PGN7W?%$6"1;5W6D/ MM+HL4N947RR3>>XY."9@P<,2ME*#R+M:*C1!,[K:&W97&70GDZ<'($U5L3P+=EQ MYQU)7'C=3>*0:CE(R\G<6GT-`W0K;GYL/YR/C.0FB\X^=K?>(]$SE<*.!,VM M<0A10[4WP`IF@T2X>0NK.;27:FA<5*(:)8U$S>X&TZYA%,=L#9-=++2$1+3< M[Y'B4J1RN,`((XZE@H8>*Z5!9.+4XY[!UEF2+WV_7HPVY[/MC:WK>UK6O?ZW MM;YW_OO];_MK`I*BF+YF:REC2_'##E5E+%2)-I5.O1M/F-NI6RP]J1$&Z&5) M+#CT?O=L/%,Z,=`,PD,*6^G9$/<')/.&4/1_!D- M#)!EDIQ]UWT.H1R`Z9-DV5>A63Q[OA@8V6GFJ*-1A1\QW(/N3W@6>,-K4"(B M,'K[]DK'QZ\0]F*80!%NFA6@0G$2VX#[W<;@"8`V#]V"#8"1GG01;X-5 MDQLM@(BM%!4BLSAN4+S&]<54;U^S8D3\?\GP,(<0"#^9.?8=".^P^SL$Q=#, M:1I#V# M2<[>5:A1U/B5!K!BC>M^+SOB;@N(^'6W(2=EN64)8DZ:'CID.=N@9X>.4@S7 M,SU2#-8465>CGL@$C]0YMA=>(1I-=NA@K;;(GWB<<.Q4*ERM7-VE>+VM>WI> MUKV_"]O6W^5Z\UXO:U[>E[6O;Y?*]O6WROZV^5_PO\[?KK"7]&D=RH$P;4F, M-F2(W<%R$GB!?;6!.\+8@,6:%Z!;86X4!)#BK1+$R=4C58Z+*$JG3I4:-F&W M5AECU`&YXU^L^)GU,\?0OP=-T_OUS3/)TB07US#GDA??.G/TF-V5GZ?>X4/W MK`^R9&YF450GB>Q$NQ"W8\=HN>FF+2L[?NVZ=ZQ8JN6YK*<_\`0#H7R!,!&.Y(%2"/TVE@0'BL^^E#!;35.K?>C1.`-GM\JB`: M=6I/F,VKB.C9+!J>,3QWLV(]4"AN*.8]L,Z7XBE+&,ST.,IVL[*2Q[;P9Z*0 MMP1W"CJ50]T[7P^P<'4HQVF[B\]R/-;EJ4;[;9$CN>H%$+&<0$PI$@I=';?$ M--@+!L:LE"K9#6`8J,`;::"E*"U;VRWP^"I5K%A0FQ`-'8*5&"--IQW[;94W M%/",[Q;5?G,\-^1#HV#_`!W2>:>RYV\:,]A0T16!6S)QH@?D:*XHZ).MQ5*, M9Q&[2!DW@M9R70:W(T!8@@0%M6@@4^TKPH^8+/BIB,N,H]`(&JPX[:;<8S*; M(O#/6-;K2:0=&`;@,?ALSV;,$0D0@2(4V.S9LSMJTXWSSSSOEE?,*4I7#F6\ M"<*9.B/!A1I&D(C3"5(6'(R:5,6#+M),033IEVA1HTD19%.G7CEVK7@K0K-& ME4EW:M^K#9CUD?-]XZFK'7'G3\O\P6Z!CL=.(!VQ=RH]X)Z:41 MV);RM#H;CR+G24@0LJ.@W^D5;B`1&UVR6/!L1ZU([!H11=%99M;5WQS[IZ5" M\D'_`+X&A.#F0"B#9$.GGF9I#8$S#'AG!K-R3&>.)H"YYAN3%) MM^S-FU6(+%=/P>9"?<=QP MKW"G?0YW'UM.?;'>7-O,&OF[R,@(!=/(3_Z""\FLF28XX,G:1.\''+&>"I[&]SP%O$\V;A$FO7JPKFQK=<=([>UO&L6@ MEN=?SHLCB6DNU4@PWNP^W!#3GU"#W)`3M$2*5*_"3H7 M\B]TR;`LKQ'.GD#9!YP22Z&[FA>$8<*PP!;[=B_0F4IGY%1.+)W=O1[,?@Y_ MX*,="TP\4JU2'1:OA$R%;[_?LRZ,_E$X"C3DSNS^9M$/0DA%.8W=SWSU(W>$ M:,1W<]1U(9(HV)+>Y)DB0S*?LK\ZQ!JQ09G1%L4BY"51.J#( M0^\C<-X%)>\B*,9TO-"D!>1&H(?8`!]X,6D""L=K%R8P]SC9:VQ45; M$QKV$4>O=+>U[7MZV_ZVO:_[;7]+VO\`JO:UZ\TI720B8D_VMYC6U&L7\[RR M80OOMYRR_//)G4_.63L_FQJS3CFLPZ^^><>T&P&%M!"T%NY7=3T6F\ M)*-1@!598H=>&'X=#^/)[L"*/Y2U`7)',[P;L;GGAXTGS$$;-%KNS0*EIG,% MI1_*W10.+%1/6KSD,J5P0OY,<%`B)A4O%Y$?K$#'" MX)F$2V:P.H6!!Y34,(*$=\GA#:[M:O&W3Q)F:<:3(#'00AA-[F2#W,MIX14":=C[[56--W<^9R;LP30^`3Q2 MI5`J-\(+!A++FYL*-K$+W2F+_)R)Y\A_%'+;U>7EUD-U,60.?N^K>W4*18YK>Z+:"-\?'OA M.C6$`L3Z)^=SK8Q(F4VO0#,(2`E,F3ZJG_`#;>.!1!O,WD9ZM,3CQ%%T=,;1JKZK1SN)>Q1T.*94#,+&'[O;>8Y.1'*'Z:9ZE,&4 M);54_G(PC#6;8%`4W8^L))+KYSEBF("EV4GW&.+NN$BL(%4JX?5$V[N#64B]7;8Z:\&7+'6;H**9.DWH47$ M&];8DV.8(T.0[&?/T>%%C51-5S%62WFK":=X##+QQ17,NHNJ?*\D2,*5%K*M M(NR<8GW?`?AY\>?.SL;DDM+GT2\Y?:!\(XFK-LW.5WSM,S76-<$@;+41-:3) M5..=TM=NM0"-1C&PU&\N&MD#IU99BQ*;?O4;MM:/E'_D[/-_1'/[H%EEH?R;3K[I*68NW/GD3C?Q8L&(WRL*N.3>3.@YL>$UR1-X>MT"$DA\,].2L+9$S@A*)9M&CV[$74K25[ MKYVV#&#ALMCHO97Q(/\`%_),,SK&XQ6MDWM-\Q4XQ?3O+&#]ZSY+Z!D9PACB MN3?R-97-O5'3"A[Q06*'](D?9RM)]:6GK+JE&K!^CV4N^S4U('DX6AID<]H5<*( MTVWG<*YH;=RAQ/+%P2D^')>3^@9UE=Y/,P]=CJ`@G&UXUC`*RV@YI)%&#N4(]VI"C*#E>S/=N M8[X5_%@X$K40JN(8,'(V4T43%;J9K@BC+TIFR@*$3>E$MP9IH!8VIVFBQ(PN M,'OM0X3*KE)`D35J]GO;18D7@)5XQG43[1\6,1;LA&D"A0]@<*M0@:5C>HHX M;JU<2T2)$&)PF5W!NM(Q2DS:QHXJ5.X-+@%468934A/$1Q57;3SU/\']F0.S M9OAUP"9$B25FWNWH]RA'CZY:=ME`ER-!WMTAAGO#N1OD<"37>S-.I\2`(VC) M!"Z3';IV8YPXFJWBIGHA&-D'09=\6GB^"HC\CBOGEU],Q,,=+UGOFR77$"WFVM M*_+21Y,F3Y>),M&7]SH;>T,. MU$2XW,ND39J-&"S3A.LQY`N!Q.$6J#?9_)HO&9QJ4U"^\IT!$Z/"4!"]Q;6B MC+1SM5.C79WBU;I2J&UJ7MS)#ILKV562RFM M'#-:,?,@(B;;,8;8`,QGMT=CLP'-]KM<2D!@`H[7MV;<]2(6)0I$"7'+9LV6 MT:,+;-FS+UROE-*4I2E*4I2O%[6R^MK7]+^MO6UK_/\`'Y_GI:UK>OI:UO6_ MK?T_/>_UO?\`&]_SWO\`.]>:4I2E*4I7B]K7O:][6O>WTO>UO6W]U_S5YI2E M*4I2E>+VME:]KV];7_-6-M]FM)IY$G]6U_9_SM5/OE.\6K1[7A(`FB1B\[AIQBV=8]Z/:B"7(O$F8;FUR1 MV,=#>WQ1T4@`B\3K@C9\M-YN,"N):-9$XUUJA`>#:[[D6S5L@;SGX@WQ,\N\ MQE.Q>,>'^;...(T4WE(9XDC,XHZI`R=-,^#AXA^R1)1J26(&:H6-Q6P=I=L= MQN-%%":=W6%%7&JQ4-@1NR[**)F-$:6^W1[7;J`U=(G0?:R,&*2D_@4J70A2 MH_M#0CUK?A4R)*F2:$_O_314D<$B/`EL;IX;]HX(TF*VV^R5/[O+N:^6>>>/8Q00WS+$3+AF-AZU2 M5Q;3,&71ZR)I;K3Z5S@<)15M6''2Y5^A(DT+W(Y298ZMT)$FE20VZDVC#7GD MKQ/&TYQT\(DE]D-J1XT?X14W7DR'>)2FVXX@ROVE3*=5+@609F\-IH5'\^N)Z3QXLB1%`WXMZ=<*@F\IBX1S7 M[="`%%O4:_6FVD7OR\DOCK%QYT:H^)<48X[$+.EW%6"Q".W7;*9@GE^9MJ>1 MG##\$2CO=@X492/@U'<D".K?'T=:[G9W7OC:&1S!77L+AU`;8PA@8(PX1ZZB')?@9-4/A-I:*GFLS(X9_9!%=M06"R/"\==*0^=C;H.,`)QO2I'F MUGR4Q")#,CA]C.1..6N5GX.L'F'*[$:8HDT8XE`2P3EO6BT9E%9(IU)<]$-3 MW*W6/-4416Q?'A.;56C(Z=KQ7G(T[T+S%/B!^LUXD1&P.QQ/06AV+YABT9%J M326T,'+8&D]+=(N0B32%2@%ZK*:08F[T\H_D(EN:GI`4V/;C5KBG--_\R>+G M=PD$ESDKI%H\Y.9PM!UI.@NN5JU6Z([D1U.1E.(6:9Z?9#ZF/$J@) M2G4)'`.M5:="Q4*NCW+$^A5GNU83#KC\1(O`GN-8#T6)=0B3#=Y3%-IQ(;AR M-0J5I$&U7;"RC8B2JUJU4G2Y[+Z-"E8JWZM>&U1NSS^^^-K^OKZW]?KZWOZ? M+\+>OR_9Z?/Y_7YUX]C'T]G^EZ?C?/.^7[,[Y>U;\_TO]+WM]+WK\]R?0HT; M4JC3KWI]^K9HWZ-^&.[5NT[<,M>W5NU[;9X;=>S7EEALPV8Y8YX97QSMEC>] MKUA2)&,<:?)WR4.U,%E:T&[B;NW?N1:VFW\$FW>DF7@O4EW[$N`VVC/W"V6 M/KZ96QV8Y8^U;UOZ9>GK;UOZ7^=Z^6XH9?T]1Z&_I>U[>J--?TO;Z7M_POE> MWYKV^=HL=0\1S+67VVW6)1_(P3>)D"/R^&W''9J+,QS`R&K/''+#?:^-JZ?/D1\6+ MZ.^32"N<&W-[>ZCB)I<.S5T#&\&^4R;Y=(>!UR-O9 MO;V;;'8!-/='B6&XG@5A`HMA2-F/$\<-C1=.`8L=M<,SVH)PSRMGNS1@@*-" M/UJ%6[VE"Q9EIS6+56>Q4L4;U&S9MRV52E[6O\K_`/C_`-E[?FO];7JD?I&# MY8\?L[O+R%<:-`V_(4D'?MV&#IPBCI2)&%.D'/@))$3R*:5A\KSB] M^*_().7#;`ZF>1*2NC8@C^-HCDX`X90\IQ"X)*%K'!!,COU(B2[W6? M;&TJD6&=>)Y(+1%=`_>/L7YAWCR!HRYQ@]N9`(VBIN7;S?T+U618V0V*U MBLNX7"XC*C#%07%XL?S*-QR^65S3&(9YLARBE0-QMMUXA<53A&GPZW'!6--:RR MI7L*)%&&&[2MV[\<\,+V]FUCM*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E M*4I7%G`89S!BS=<0D:=`'AJ\,;"&4*4H(,!RB7:A)B2HQ=I4(2(PDBW[T9`> MMT;TBU)NVIE.G;IV9X9=(^=4G4_"O;?7$4\T].=:0IXGN.F3`.DHQO?D.,R<(ED/>5Y@BARQJ9,2!%;><"4S'35=*IS,-`N!`2P9/ MV"_%P])<6OOO>(Y(ZB?7739A#H.'PT/S!(:.,4Y\Q'$I\<\^3REOK4Q(SF0S MR@=29DTFO!DD8:V:H0J1;,U&_P!?>9;R[PB_KXDGC#H#BB2R.J7.>2;@.D>7 M7.X4P.#.P6$X$XW6[8F?)#>B4Y,F2+(A."F#Y9MGL',5W[U"1R#E+:<99:-W M%Q_UO%_:,.)9:C72Y`*D8X34?2?&+^#;6Q*<)3`S\TR=^0]*[347R4-E_LM< MIT:R*/V]X\F.5BG*WEQ1MFQ!-7`"3O"I&;N=LTY19UQVQS!!_2[L+OGH3E_G MN5&DU89?[J=.6&R02X+$['KD?$5;9;SMNURNFC5V@4+N2JE*?6E%8;LJMHBZ M,&!"L<,:(XK:HECQO&K4!,AC-`'ISTBFXUFT.T"@HA%CMV;E&>E$A3:M7OU6 M]0L5;+9J5BA0KW;M^S/*4I2J]9(_M1^1?\$/>G^]/`56%4I2E*4I2HTSGQER M)T\6!'ND.7>>Y]-M<N&A5KR`&5`Q"L6ZM:M4E1; M-.G>IUX;]N&6S&V5OI@KC[D[EY6Y%_-G,T!<_K7BF%HW8KA:(6%&"AS)0FY: MH#IC^YF`0V9?0*WDB&X=J7Y;\$>UU[>MK_L^G MSM>U[?.U[7]+VO:]KVO:U[7M>U4=31&DB>+"5W/U[RZSCKWX^6U2Z)?F)W*"3W?1 M92KV*%FI*1)X-\-L5J$[;!A1^6"/"7_L8?\`=Q_^C;_V5[6M:WRM;TM^%J4I M2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*K#G[Q3P?/LV2?/:B7^M(C> MLU,5C1Q+**`^BG5$K3D5H1R.<@EJ"'BVP*':C/)QXYWN9'[LCFHTY:#9+#'3 MKLL46V0F\2\,M'QG]2=:>-(TO=9#:_20'K/D627VZB#A62GR^$9#&@S&)=:H MA>Z;0]>1]C,;T?E1*#;JV%8V,L-WIPX]'=?K3]A6]K7M>U[>MK_*]K_2]OPO M6D)L-OF)H?E9^P)"0V994'"B;R!1$B=02+54L.Q/H0ZMHC)\$`A84/WU9H0O&D5E@]*4I2J] M9(_M1^1?\$/>G^]/`56%4I2E*4I2E*4I2E>,K6O:WK_WL;_MME;TKH1P'XFI M7F-_]<2=``&/I'8+I\B/D!YT1Q#*?3?5',D9\@;XVZ;<29F2_%36Y4E"/K2B MSR3?)%1+V@I>/$$%+I2-`RUGNWP:YS(M%QG@?\>\*;^7>?.O)O7OGIOI=N$I MN:,=R!/KS<,GA8$#L6?Y,8&`KFQGO$B;%Q*@,69ND^O<&G<>DM<0+$=)"0%@ MW).AT=E"UK8V]+6]/];W_&]_K>]_SWOZWO\`GO7FE*4I2E*4I2E*4I2E*4I2 ME*4I2E*4I2E*4I2E*4I2E*56IY->89$FJ*F5.'-MT8[M+C-Y;.@.6"JGVM:= MTGQ@O<.D>`7'OTWU*-C"Z2CG,Q%CE2?%IDV@H0:SDVYVWMI-EC)?D'J*.>SN M<(IZ3BW8KU-:3FUK*;0)6UM3B9#I'J5`1\1P[DGLX9('E'3Q&G&6ZT&6-KI3 M@19CA?/3EJV9R2R_JW^5K^MO3TO]+^OR],OE?^C\_P"E?TOZ6];WMZ5_/[Z$ M7\G3KU?WIY&`4D/CF/LR.Y0&)?'VQ`7*'<[*-K4WN7,RCX\DC0*=19GN1.6;:W99-BF5[AEUJ'9O0J4RC;(6E* M4JO62/[4?D7_``0]Z?[T\!5852E*4I2E*4I2E*4JN5[^(?QAR2]'9(K\X0Y= M=KY?;D-/!XNL[$;87G7,Z7&14%CK@-$-J7WR\N7)JE*\@NW7RWJE>_;OVY99 MYWO4TXCB"+X$CEKQ%"[":L81BRD:E`TV(R0Z4`UVZC6$5I=6F$B$6&M*BTJ2 MA%>OWX:L+6V*U:C?GZY[WX_A\K_LO^:_X7_-5(@_+9XV/)!^3_L8"^*O*G(!`F`OZ M9)V]!/D@P#_'&@6G*^.I*.;_`&RT`ZIP(-&6]3ELG=C%]2-,FV/C+WUWEK^M MO6WY_P!E_P!MK_.U_P`;7^=OSU^?NL?QV?\`]7;_`/CKWM:UK6M;U]+?C>^5 M_P!M\KWO?]MZ\TI2E5ZR1_:C\B_X(>]/]Z>`JL*I2E*4I2E*4I2E*4I2E*4I M2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I47NS.5F)VGS;*'.;_6DP M(Y^A=7Y//=O9>X=T8R`WUR9Q1Q*K*78[4^X>\8V>PL(\&\JU*-/M+A6*3?ED MD5J=6S0/C-ZK??1,,.>.^A$J%O\`9G)KY6\Z]=M1'JQ2)-LFM<>C6@I6:Z2^ MM-GNCF?6*M`2VQ2:='K%YI7$2"(-RC)O*LL;'Z4I2E*KUDC^U'Y%_P`$/>G^ M]/`56%4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E M*4I2E*4I5)WD$0D.%^CXR\KK$1*[1GH'MCG'R2-L0DW*,3/,)9P;,(UZ4S&( M<-NQ8Z>2G^>N1/$]0T@650:[7T/S4I1[>37UW2CR"$L@1DQBQ(1'$4J=<@(( M%.E8A7(E>G!0D6(E:?/9H5)%2?9K4)5.G//5OT;->W7EEAGC>_V4KCRRE:B& M$%8X?D6()4*M0B%X*=*/,DKT)MNU*/Q5J/5.ER6[\-:7%1O_`.%HRW6V[/Z& M&5JZ<\/>:[NK7`7>C\D5_P#.SDZ"@_G^09.7\>G8,DJ&.DN6)JU9Q2)84?WB MUR&;%.BH(3.!^$VT\)&T;@)H973QP&?T9/^77?),A:>J>B>/94?+/!K4AV M5V9(SCB#CKO)NR<&:Q7$BN9!S.?.'P^(MP:<=>%T*S(FVCJ*VK*^5[J!:S#Z M:K996^4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E M*4I2E*4I6/.YKMQ\-9QLIXA!KE:+P!E6JZ6X92ZEPAP-QQH=X8X$+(=^.>A: M,*BUJI`O2;L,M2A*HVZL[7QSO73U\5OE+[79;3W\,1#P*)TE+`]YQ,/$Z"VT=? M;=/D0TC$.M5?#WN"73;+V+28K@W,WAKM;AYK&+*LA#D"E0!3%"O6BUN0XR@4 M#%V*0D.WIB`]5=*JW63KD*C0L1[KX*4N[5OU:]F-`47>`Y*UG!(QY_=Y=AO( MX(B<_`_(\F`'DV(SG#F^/'*%BA.0%OJ29`['Z$?7';R9#?H0CA8@?I2"@@ MP8/]ZLW)]RY3K^2+>GE'Y&^O_P"9#WI];WO_`/KIX"O^>]_Q_P!+?2UJL+I2 ME*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2 MO7/&^5K6MZ?U\,OG^&.>.5_V^EK^GZ_PKK>O)W#7*/-=T*D@'&*]VCV<]Z%-G>^O&9E*4I5>LD?VH_(O^"'O3_>G@*K" MJ4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E M*4I2E*4I2J]9(_M1^1?\$/>G^]/`56%4I2E*4I2E*4I2E*4I2E*4I2E*4I2E M*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E5ZR1_:C\B_X(>]/]Z>`J ML*I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E M*4I2E*4I2E*KUDC^U'Y%_P`$/>G^]/`56%4I2E*4I2E*4I2E*4I2E*4I2E*4 MI2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E5ZR1_:C\B_P""'O3_ M`'IX"JPJE*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E* M4I2E*4I2E*4I2E:HG"1/6)`ADZE8F&H<- MRC.V>S>M)E%J(4(&(M*DD7*K48P:D5+E6C1LC4XO)QP"TN=FOUBX^MH0$<\O M0UH;#7D]4]4&0,RZ]NO=MWL](E364&[O(5K3+,W`T"`AF?&C=:!5G MJF$QWRS9,9S8D*/'2`>S%>H(8YVB[VJ60G6VY6\92:UPDV#,C=RA`3&$4>[4 MI1K$F_9IWZL\OSO;Y_+T_-?T^ M?X7^E_I\_2_R_/\`6U*4IZ^OK]?E?T^=KV_R]?K;]=O6W^5Z4I2U_7Y_/\_U MM>WTOZ?2_I?_`-OUM\J4I_X_'_2G_C\/]:4I>_I;U^?[+7O?_*WK>E*4O?T] M/K\[^GTO?_/T^EOUW]+?YVI2E/7YVM\_GZ_FOZ?+\;_2WU^7K?Y_F^EZ4I3U M^?I^WZ7]/GZ_G^GYOG;ZV^7K];4I2GK]?U?+Z7_#U^7X_7ZV^7KZV^MKTI2G MKZ_];?.U[?2_I^?_`*7^E[?.WRI2E+7];>OX_/YVO:_[;7^=O[K_`#I2E[^E MO7Y_+\+7O?\`RMZWO^RU*4I>_I^/SOZ?*U[_`.GTM^N_RI2E/7YVM\_G^J_I M\OQO]+?M^OYJ4I3U^?I\_IZ_2_I_G]/7]7KZ_P"=J4I3U^MOG\OU7M^OY7O\ MK_L]?G\OK2E*6OZ_C];V^=KV^G]_YOPO]+_FI2E+7];>OX_/YVO:_P"VU_G; M^Z_SI2E[^EKW_#Y_*U[W_P`K?._]UOG2E*7OZ?C];6^5KW^O]WYOQO\`2WYZ M4I5.GG*;S>/\.WVNAE=#N$4V)W@E]?EWS(V1C^D;GPJQGKK=#38,Z+ M[;;;\Z)A_D"5FD7Z#SE[BJ&HXA7K62^81#=D4Y,A8, MMMT(4JG22)=D3P'Q/*,*>)CD5@3`SW!'KST!).=6MA.M&L'.5ELR1)NDJ0HW M:QP20TIUP0F&CUSMI&I!+-.I4#SQ^S%&G3O2[-.&5OKB[N)U=&`.BP_=T3MX MTQ&A-$:1VWU/$6!Q`#C>:7G&[O+!SZR_4`O>YG"(RB1C#T3EU:`.A1BG-J=X M'#(OKTC\\^X?R7_I!8$_=]W_`(NZ?1F+E#AD]O1JVC@@EPVI7-$4BBW!YX`U36;VSK>V MH&3,7?)7-UK<-ZC(WD@`VQUH]8O'7NV3]P_DO_2"P)^[[O\`Q=T^X?R7_I!8 M$_=]W_B[KQ>!O)=>U[?]H-`GSM>WR\?=[7^?X7_G=_6M<1_QMY$(W)RB5">1 MF+B.^6I.)RLX-+EX:4G$@<\4:K.:&X.T-&_K?79OM'0.9(Q8D!89*?=&5YTC MFLVYD[Z]&R/N'\E_Z06!/W?=_P"+NGW#^2_](+`G[ON_\7=><8(\EULLVM(CXT\B$ M,,9&P&SY&HO-"$1Y].+61>O#6]S.':MD!^N>1"Z?>6W=:I\LQHXPZUXQNH<= M&&L0VT8@1AEOLA^)W;*^X?R7_I!8$_=]W_B[I]P_DO\`T@L"?N^[_P`7=8R] M>7/(\^V:[6.7\A\-(13R:[B:1)VR-?J3J,M&_#7EIS,KESR/,1FM)CB/(?#2X4S6NW6D-7'N#-YSC[>>>?LVM[6>67KE?Q]P_DO\` MT@L"?N^[_P`7=/N'\E_Z06!/W?=_XNZUO('&WD0D@G%Q4WY&8N';XEDX9*S? MTMKAI2#2&#PMJO%H:0[OT:.M]GY0-+>.>Y-8K!9Y)O>F4`(C@LU9C/=[]CV@ M;R76M:W_`&@T"?*UK?/Q]WO?Y?C?^=W]:\_GR"9+SULM:S64RUZ=D_0W+);@')5VWK5/? M0W!!MTKQC2#XZKX@6PD$A,-ZG6/PWY[&^X?R7_I!8$_=]W_B[I]P_DO_`$@L M"?N^[_Q=UQ9SG#R3.`*9`K/(5!^A(;$DPRK>/X$VHE^A.50*!^]0A5Z^N[YI MENC4ISW(U%L<[:5.&K9EKVXXWUY8]&W)GD9BV.F!&0'R*1&5!QRR&FP@Q1U\ M([C[H)B6D)N+6 MP7,,;AI0UG@,1+[ZK[E;<<&CK93F)*Z[:K8IUOPJGW-L\[XZ;YWQSPV7>"/) M=?+++_M!(#M[6667I;Q^9WMC[65\O9M?/KW+.]K>OI;VLLLO2UO:RROZWOX^ MX?R7_I!8$_=]W_B[I]P_DO\`T@L"?N^[_P`7=:TDGC+R'2EE'V3@\C$7C+QM M*3.EL+9J\.+&_8H?9-R=QP1S63=`Y_#W(^X1^PM2^YR][LK M&!O)=CC;&WD&@6]K6M:U[^/N][W]+>GSO_.[^=_QKS]P_DO_`$@L"?N^[_Q= MT^X?R7_I!8$_=]W_`(NZUFZ.,?(:[9&BN3B7D8B]*=B+\O\`\GA@CAU8-:YG M[QFVD:Y;\L06KKG+2X?LA&CP7-GV]J7[*+;-ZS9\;KSLGPV9]P_DO_2"P)^[ M[O\`Q=T^X?R7_I!8$_=]W_B[I]P_DO\`T@L"?N^[_P`7=:V3<:^1!+,!J:]? MD9B[-T'8R;,5*@FWAM3FR$X%J.]VO,>80-?^=O;0E=JLB\B8\N=LHS^T`:(* M/R1Z\QN"G;LG[A_)?^D%@3]WW?\`B[I]P_DO_2"P)^[[O_%W3[A_)?\`I!8$ M_=]W_B[K6S0XU\B#*>\M/X9Y&8N6EYE<+3E90C9 MUOKU-L6O#MM"4-(=>Q5BO2Z]KV_P"T&@3YVO;Y>/N_K\__`.;NM<1EQKY$(H'. MP8W_`",Q<5T/&3I)E8EM=O#2IPJD1Z476N>!P.&W[^M]7VG"VYR.\H):8=*%'D'0X-W6J;8 M;<"M*CU[RY7-,GR(+L]ZO+1KRVY8UL#[A_)?^D%@3]WW?^+NGW#^2_\`2"P) M^[[O_%W6OY8X_P#(I,<7R+$KD\C$5!6])K(<[".%V7PMN;;O%B78'5A2!!KN M#3UJIV!'`D2K-F\05P3*,AZ[#0KQT;,M6.-9WH@'R6)]&G1AY!X'RPT:=.C# M+;X_L]FS+'3JPU8Y;,\NO/7//+'"U\\OEZY7O>UK6]+6_7[A_)?^D%@3]WW? M^+NGW#^2_P#2"P)^[[O_`!=UP1+D?N!_N**\IA[Q8;A8$?3/%4P&FK&W(FZ) MW&\;Q4[$;P0,_>]\.EWC@+;KB(($J%S:MC7,6(AKJAWN,,56>S&SFUO2UK>O MKZ6M;U_'T_/7FE?GNTZE&K9HWZ\-NG;AGKVZMF-L]>S7LQOAGKSQRM>V6&>& M66&>-[7QRQO?'*U[7O:OE0C1XM`DƬ<-')4Z)`A0:,$:1$B2:<$Z5&C3) M<=>I.E3)]6I.G3:,,-.G1JUZ=6O'7AAC:OV3?)7"D73A-O/Q"..E7&_H*YO, M]+G=+4@)]+T#Z:XEVMADZVG"N\BD%*9I>))PNX./U;XZ2G6,*79K1;F>P,P, M)CT4<73YN^D.9-N/BLDL"5H)VL-O'&D14-B2'# M&KF5.F2YB@^+&:494B'FTK>,N-S40Y_SAUW%L)4V)93?B%ZC5!\P"Y?RGI6!BK8CEPUK0 M,!>B-;[A;7]?\[V^?R^E[V_^SY?C;YU`;H/R#Q]SAT/"O/SSB*?"MIM>T51L M%EYOLYM:HA$/Z:'$X6VQ6C+>LL9L]L ME$A'.-\6^:KFR4Y4;,="8XG1$W7--+?@7"9E3;9^^*@LA2@Y94"<\"S:A*^, MWU?1T*)B2>9I-["T-2[Y#[JAKM]_E:UKWO?]5OK57YGRUP9.XXWZ'?O=4+-IVN&6I#U+XK M3L5B;&/#*:>G,.7M\G)R":3*81'9$/O)O)K1*=CL8XS8QH$7WG$TI-+(I*E=N---'GY;P5$S-FV>HCWK&L]'&[1[XA^/ M'JD(N1<:98ABG2S=>[;8CO=1QHE$5IR<9]9,;MSGII='1TU)&8S6=QZ26WH: ME.91BR^M<,22CO M>UK>M_QM;]M[VM:W[;WM;\/Q^55`K_,_SDBO-&S*-9UUC(X:O1KAB]P*P+"U M!^H"'*\T-WG&8&K"2='(9)TI'`(G5Y,Z.PR>7&O&6#L5N-(<:V1AOHBI!$9G MFGY<=3:EAU$&1.[2%L"'R\ZQY7C//=R//HQGN]REC1DU.@E' M&S49\@CXY>+F6.UCN88!VLMT(G!A8]SU-;7Z3@6%NAF2@."F=.<51_+S4&.; M0/3.,>W9&:PMVAD)Y.)(F!6DPE'ED^@EJ&%B@_!7AMQ1$5J:VM3LU_V1UI'/ M$//4A=)2JW94=#(C@(4.&A,/QDZI1=F:02&*'%>_:,;2+S@6AH7;Q=P.=[M5A'HH:QI'FS'`_ASKML%:M%<^>:_FB= MCS'0+H]F^'VD^T3N1CY;E,"RQ46C9&8//HWJY\1&?+"7R5=`)Y-/G,LFDPN9 M+,Y#'&6*%PM`8^23T;A0'JFYQ;V''?GMI5LZRA50&U+B@+>N'(2NY(<3CU"?4=$AB^"P8EW-,LGHH7BQ^2 MHO:$C2`F8C;(N+)CQ$R#,CR:[MJ+7;X9N,9D`=>PDXG*859Z4(Q!KR3I_?;K M*""T>-T*UR:J$IYR.;@T:,^0B41=")R#FEV=X261XD"QBYW8+?D!EFBQSJ`6 M?8TH.R)G\/=LP2?$4-,IR1_)CB:BR0))&#SI\"F;KR4`>>:/FIYV>DXPSS@. MC65`\SRHYGPR'$Q7P[N98^,Q&^8TFXI`K[93GT//H,+:2'2"=H0N93!^=,IJ M5.1EHL7(UM9C2M'Z%5QE1"[9[6A_@V&TLS3)8RK%&W\S8N:3?`*6@,*.E^/M M8I3@PVIP2(ZV''360Z40XN=.NA^O=J-0``"E"),SI]SIT*(;N#S*0\/,08U& MI`'2,G2!T-"T=S#'$9L`9$)1XD*.UHCB^6

7WF?L+H09`,%B78X-Y.*V'+VM\&75!341XM: M1(=9\T@\D\4N&8D/1I>Z)OOML@7,4`0P7;37=Z[8&-G4FM&K6:;6:@KVEWU& MO$V4=#G9'\JRH[9,%3"ZP+*B5"Q-IM-'W/K`RDZ:9`*+Y*?\;-;0$8;.NF6[ MA*5PK'BY%Q!"):#9.K\]^I/$:0/./R^RW.]1`"-I_EIM,"+QD[NA]QYX@Q@XI)!$O(&H.SV*X5C<?1)%PC6-LCM+*I./4NN/4F38+$ MC\UR`L8<+Z&YH_*H._#3AY;,H^9[:8 M`]Z*G<9DU\Q@&BPGL>DCM=B#74I7PW/SCWN!2^\(XUM"$'D>1O0DF(M'[?S; MFGS&\Q];=`L3GZ%`3U,EGS$K%F'4Y7$YH(96(<`_([)R*E%[XM=4RBY_<9EM M)1V+=?.Q@Q(\`#1QH+`=+'. M?D:4`_"+P^]S&%G6WG*AN1:8R.B9M218P^0%+N`F!B2RGC+KIE=L0SKFM@M1 MTL\#D[W6S+BG6>B=TJLR307:QY%8.?J&*W*1E5"W0&B.I MQ7:VPZS4XD8="X-K&\G"UA&.KV<-[5^;)W;G3D%QG/;0!GVXVI1;6AT!@KH4 MM!<;0HE"E4EUXJR+`=3X9)37NNDR4H2S4=SB`%A^Y(1%EE:13KSK.A-HV[;X:M>>S*V%\=>&>=\ M<;TUAO./S"5BLE*9.-YV8R*XKF:0&4\@H7'M!U1PJ38"P)B51\G8/W?A%ZY@ MI'YAN"Z[R@)?2X`@=12$W)'=$>A@[#FM-QPVF@YY]&1+IWO#)_D,&PG?3;&M] MX.QAM..9%-;UHV/'DYMZ'.VS01'SW4A1\=0+5(C]7&"+B%*$@B(YX[\M6KWZ1GE+SC&*N2-\9RK+N_`ZVFX.8\/MT4;Y MRV@5J)$RKI/L^/V"R6]JV[SSYDN3GLRXZ8C8'$3SJ16VP^=^CSS&[<&J34%S%IT0=I M:2L&W6#B^9+.O)E;ILQFUC@XA5Y8L"1##ABU*.12&L"-X"J<&#H:ZXQ:K:_K M:U_2]O6UK^E_K;U_-?T];>MOS_.]0)[X\BD%^/%F,!U3$D<;@*2D[3#/83-: MA2-&Z5.+FTS3C^="]0Z9ED.*8P;HD"V`"K?N4N9^"=Y4LM"-MOI2Y\V/0;(S MR_YIX$B%]NM@J(5Z0?1EC14*FEXIV&U6$M5M>.D$+#>A9A<1A,X9';:?+&!8 MH>$5FW\&"$3CG.EI79C8C($^36TBG1R'BSR#`Y3ZE%IX!+'+#QOH-HR M\15P6:BAPPDG/CVXR9&WY,F:75(C.%R\1(96BT/($?M-UN#`,ZK+``K:T7)K M&6$57+UKY-X+XZE03%DB-*5'(H31N`FF5'<[G7JGZ.4/`6QP[F MA&9Y="+7J!:%P3I>3>VK4JML!GDS-Y+W>YPI$]3@V9XZ\,]F7M>SACEGE[.. M6>7ICC?*_LX86OEE?TM?TQQM?+*_I:UKWO:U53Y>6^("T<2K(OG%YG`$&RD8D6="S?K>//<==+-S",&DSM9);&STA%U=+.-2I M&2$_6%8<7BZ`P3:_I:WK>_I^:UOSW_``M56+_\L\*Q=-$V M0P_X=Z09^^&H;Z(F[4^W&PFT*:,DLWF`6UETG$6&'WOC*4M;=5KW@+;$:22] M8X9\43$ZT9T!%KY=:X,IUY:6V>=CFP4TG(\'="W2S0$CVH\#S(7FFS&B<)+Q MJ)YKC/FZ=VJQ7$HE-((;VZ#)VE=L,.0W=,N^*8^TH]1Q_A'47CP$2"!*&>.@!@='$V&^7+';D3;%C2<#M9QX=@Y6F7L# M=3,=;F9[L"_`.-KGBH0FB6;9$[-F&K#+9LRQPPPQOGGGGE;####&U[Y9YY97 MMCCAAC:^665[^F.-KWO\K52Q'OG2Y0E>)9>FE@M*4B[$C!]0HQ@Y3)7#ZC?) M>Z=9'*1ZU##>!-J5W2[62F'HP)N23[?FAM1D^447(<7>G:JS0HQ3:\8<:[&=(>%66==T139"LK]!1+.`]U/&;P,3`V4_XSA. M2-[>:KTD9LS"H>8'7&NR--;]*#0*BYN-7\#E6.F%)[9TET[`$>XA6DV"7XX+PI?4@))\"0E=A@K'+<=Z-3ACNTYVMQ$U2XR8`AZ5I MUDI57V21(=Y-8@9T>MHD['*L1C4UKJ2"I.'$K-B9"GM?>KWXZ] M&JWM[+7M50Z/.+S0PHR*O^1XNGR.S[0D4:RI&B-Q`X\,R:PP)KF59UL`D8AH MCB1W\S#C5<406`[!2)LO,HYM#R=K>9)\*"-J%.I-Q#\\[W,L78M\3(L,]*,Z M1,I*D2+9-BDP$AS4]X<U_G;\;V_;:][7_ZVJ(70G:<7(V&::48N4K'`%Q&T#A((]C^E14G'1XUL]VEM$?@&OM<:J0#VK#:1;C0+"!I MHB,A_N\RL')1\OW-0;TZR7)&[:B5\LYFR,P&TSG--D?SAT26Y;C-\,0-N>Q$ MNU13DEH$43:`OEH(P;OHG$'2`FYS7"KFB MX"YP\,,;9+<-=$AYA/PQ/C=>3ZFQMQ46JG<;:*A'#H;<@-@6[`>DZ&VZ=N MT09U"RZ7`H,V[=NQ`NQWI<]F>6J^5]J4I4%)^X='37*SUFP!-TO0K)KLY"?O M'PYWQ:J;*$TR6K($C-R1B3]9Y`P#)K!4BC%K=UC0)C'==,)3K-I%&EU&TH\B MEA$SO!M$H6,#D8.:?I<<`U!%;1B^%5[<:$(1=M@7)H3ZS>H<)!:(QA1R.#.Z M377.T;1R_9&>DG(7@8D9MNFM;TMZ?KO?\`;>][W_ZW^7X?2JSNPO&P*[`EM@R:X.E)^CX5'JUE.P!' M#.VQL1:@.5XO4/(A'$NL0J]&&Y7Q%+U'D7CE@^MD8NIK#9=;S=;30D5&8;J! M2C6Z:&^$SG`0^XQ+()#F35$[&!\SZW1`5R[5LP93?'(<0FH1@J17:=TM?1(P MLP#9)N^3F"LYWM]L/4^#;1PX+S5#%-B$H>+?'1S[P4Y>@C,`6?0T-/[CC`RM M9[I?SQ?(-BBHEB=M1,TVLS%#S/.`UJ#)1+?S6^^+$B);3BNT-I,0U,UM-!O@ M9ZWM:]KVO\[7M>U[?JO\KU2]T[X3X1Z?E*3'V=FF;&.U)9D'*9GA&+&TQ8D$ MJIE)P:DY?=SW2OPK'A.6T@UX\\8$X[,QWI?5H^Q4FB+L2`=)O9;UYXUX6.7G MG-+YD"27-*S_`(F=C[F.7`G-)%R(FU&+#F#H-"QQ\O2`V'.PAK4EZZ@]I8(U M2WF\1D)4W6,3,N<@V4"3842ZQLR^)^-8TX4A53!T5&'N>;2N49@E;>3D!TEW M:X,SQ:;@DT8`A[0@MGB]NQ!+#7G,FS'8<8<4M=XR:W MR\FQ[&A*Q"23SG8,`4JR M(66\FWJRK*Z`\.PZ?)>>LH M$>NIW;J%YP$.Y@2M#0T8+=2>,X25L3!A2:U8/=#VCH\[(<)38@WEE\J/!CDA MKN\5<5Q=PK&S MYBV)3#[,MY^3K,D\D5$@N\Z]3*5PS$\%;J(B$IAPD29+:)!ZMR0.B4K5:DR; MLBV.1VD3KQ,'W`4WE-4:[YBBE^QBED*1HG6/9M$0**2HCO2K276CR`U3;#8A)H%H]4J3;:B&MX*8)#,N4&\=G.='$YI+ M0+RNA[(TT2,?*.96+=,L_K$O+$7L)B1N"C%G%BE)_<8;&:=/1T^`"(V#]:3HV<4722;JY$^CY9-$ MVITQ#AC+(X'H6-F`W!'+:(,-N!&AO'8^X6EB%S%K6M\K?C>_[DQH(6F:-QY+D8JU^]JNC0VG\`=+&6ID-;FWM9>A&!=4DDB+6L&1APHY- MMZ#?$E$4!RYSJ^FG+\S$XWY/`)$T"P8X_NO6M=FN_7SWAS&2>:R0D<<#YJ=5 MB\8["V[>S'+(9%D(GDX"SE%A$>O4$%![7_I5?/D-\=\:>1>.F;&DGN\ZTP;2 M=\&T!*XS!1FT9HGB.T60'IR+9+-MI>P%YR7.=>LS[`7RE`[I5.QDN*P MAOHVO$D61\R'DT[!9":K39B76G<*HBO6K;RI@+QXM""^F''TME+\IR(7LPY% MBJ*&2[T,7CFU#D9RQ)C:EM\-(479$>M5\2+CO=K.:R9O'I>=#W`2*4(HL83+=0B?#BTQ3>2KTO2\NAYM9\E M0/(<+S.S(_YZ8FF#T/-\8R+#\61I'T*-J*DD&)HL%L68Y='KF:M8N]$N6O\` M)ELG1@$]N-K6M:V-OI:UK6_ MNM;T^M5&]>^))H=CS"8D]_=.]'@@JMN/,8UXZ;BN,-@B,C,CPD6YWD0C&3T. M1Z3E-G-9]Q"&SSBYID:!>S.W/K<221HTAF#=8#IXI@MHB[9'<379C(W+ MD+0BYI,A@M,6C:4?M05H%MYNI;*U*%8<+*2)HLO6[9>7MZV]/I^NWUM^%_GZ MV^7Z[7M^-JI8W2#9A1"FBM$QACVF29XSGV?Q) M=QI(]T2>]F;,,DQ$RUY-LO1['$#6$Z2`)J8#Q^8G`+PJSP704I*JS6N^.5O7UQRM;UM>UK_FJB&(/Y/WR9%[Y//4F]9&>_Y4(9'`.1O_ M`)-0C%K?<39?,4RS#HU(<$0;%<:C"#A:K7GN9UR1\9(-;H)N)[8$%BS4C;3= M&(OC4>`Z(%@"ZQ=T_P!&$IM^Q,XRPZ!,"H'./+5SULYUW3=2IR[M10B%57815&[8AN,8ZB)E:EJ=FQ:Q&A'+2T$ ME^\H1T-ECMT:UP&E>357NJ)+=0D4DP5KU.62A8HML4;K^WLRK5G6O-+5Z]@9 MV0"]3SB;+<=QJ.#:TRU;C+'$JB-909S9]FJU MGPN>A5[A1JKZ?_A_$2?T3,\ZOCJR:W&/GQXQ\MD5AF69!I7+*'HS?K0D5M

7@_@Q[N5T'C,VS MGM1"7O)1CE7A)%CT^1ZV3J=N3E]XC<$ MM;`HRT0^PPIN4:[%>1>7FKR'#".(6NYG.]]BA\2G*+P>[PUMQ$=>,CS5([FE M:1G)O",P&V&2V49-XNPON%-=G-L&W``JR,:/06]QM4*.7Z=@DET5%!"-PTP2 M5!Q;>:;IU`^XPVME04PV-\IJ7[FZY6L^6^ZV%(,?.U%94W7Y'SW;9ELNUMD% M@X@DME?0HTUEL#P>PW$T<-9L1AT'T"TI%B]\P._X6F>V46&G-%1.`X]E%@`0 M0)GF([51BN89U//<]E2[#(L_)LC54I+D#50@1#9:B,9*WESQNPKR4^HS><;N M&02.F(>/VMQTPP#N,(#:$4T1DEF)7?+[VKOLQ,442%+SN6`EDAK<%"<$LULY MLZ!`,5H0XZ;6%U!KMGAAH]G#XO5K)#><0R+#9Y]%H^DMCAH[=10./E:+W3#$ MHM]4TY:9S^C\N/>$> MC8]S;X[H6/R[\%&8]//)XP'TU'48PS),(GM[O81T5I"IHAA*(&2R'D'VR M<6$--!#.DBL(6W6.\_<=1OSE*4[RBR";E5+9O00.V;`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`:CJ?.B0N8,M"+% M:%.X1)X!O6)TZ[9N3:38,R(V[L,-9,410Y;T>ZCB+_Y//R-'[0EAH$WW*+D2 MS+#DLKT')!,+`J@O,J64R\/+SND2$ M6Q"N;'/[B#"H&C-I-&1.>A4>2``;(E8GQ<"HDK3$AU^.&%M>..%KY7MC:V-K MYY99YWM:UK6]K/.^6>=_2UK7SSRRSRO_`$L\LLKWO>./0_-+5Z-(<]$70><0 M/;SITE&O@W[C+8''4PFX^&V.`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`"]?S6^=_P`/STMEC?Z98W];>U;T MO:_KC]/7Y7^GK\O7Z5B9Q_L5L:UVYQO)J`-(Q8`'D=IMR!1.I`O=2O!`V42W M807)\4BMPK=NM&"3*+Z]YA5LP3CL%.[/'"^66SPO?TMEC>_K>WI;*U[^N/RR MMZ>OKZVO\K_A^>L?/.YK-:Z6SE<@!OW7>^^"L;-#!%U?PWNKJ/A?M%6E^(]Q M;=J]][GV_=>]U^\]GV\/:^C0Y&^JVB]"8X'W[S:'>3#Z=)-!MVE1R:VG)0O& MZ]:C+,@AT8J$^6Y8CQW)M6._3?/;C;;KOES%\\+>GKEC;VOZOKE:WM?W>M_G M];?3\:7SPM>]KY8VO;ZVOE:U[?W_`#I[>%_3TSQOZWO:W]*WSO;ZVM\_G>WY M[?6U/:QOE?&V6-\K?7'UM[5O[[>OK;ZVI;/"_KZ98W]G^MZ96O[/]_S^7TO] M?PI;+&]K7MEC>U[^EKVO:]KW_"U_7YW^5_E:O3-1HU9:\=F[5AENV>ZU8Y[, M,,MFWTO?W>NV65KYY^EKW]C&U\O2U[^E<(VW6UWB&2N-I.,"Z&^NVK=",XW3 M`TX'5[ARU0-(:DQ,6J5H5&U"12*D"S7I49YI5B90EWXZU&G;KPYZ^6-KVQOE MC;*_TM>]K7O_`'6O?UO^RO@0EQ1/%7F.)(%^"%>J%KUJY'UMZ>OK\OKZ_F]/QKCT1862NNL/)( M%UQB_<+(V1K4RJZ`DFPU[%`];9/MV72+=&&W5GN2*/=J-6&S#+9JQQSQO?[K MYX6M;*^6-L;_`$ROE:UK^OT]+^OI?UKVI2E*X=PN$`T0)ITNHT);;9;@M><< M#A/$4@@(#"BTVQ:3+%RB_V6.6.5K98Y8Y6O>U\U[7M\KU[4KC"AD0$ MU)]Y@H.%:5:U,.2[22Y*@UJ2"W.^M&A3YJ]VG'>L59VO@F2ZKYJ-^=KXZ=>> M5O2O?`L+V$]X7`B@S+I4F@@I%X+$V1+0A5;=NA,LW(,=MU>I*HW:-VG0IV:< M=.[;JV:]>>6>O/''\!C@!&D&PH(,"RHW3M4Z-J\:11KT6K.6*G7ELMFGRQRQW6POCE:V*M>68N>X8PXF;([#=K?;V_H3ER@@HL0#-^C3ECNW:5RA/LUZKVV9XVP_I5D()V-AT64Y-MQ`C^* M.^K%7D$,#2^*7+=CGEIQ4Y#E2G%/EMQU[,M5MU\+[+89WPME;#+T^P><#%=Y M)*,+#2*D,LN/+)T*](LWC%UL?;NB(:4V[;L0J[87ME=,JQT[[8WME?7Z7M>^ M.`I+CMSN0^SFV^V:?=K4OA9T-<(Z0)9Q-N^S9;5A8^#'D%)4+?/;>VO'[32) M?79>VNW].]L;_>\'LSH^!J7,^W6VF6W$>S1J5GW:>$MH(EVJMMM";6I+&UB$ M?HV*-V6.K1AM4X9[ME[8:L<\OE7,#"PLT-0F1!%`4$$TNA<.*#EB9<.7HE6O M':F5HER7;N2*TJC5ECLT*$^[;IW:\L<]>>6-[7K[KYX6MZWSQM:]O6U[Y6M: M]K_2_P`[_2_XT]K'^E_2Q_H_UOG;^C_S?/Y?MI;/"]KWMEC>V/K[5[96]+>G MU];^OI;T_/ZT]O#V?:]O'V?^][5O9_S]?3_K6/J'PW:M MF&O9ALUYX;;6RUYXYXY8[+7MZVOAEC>^.=KVO:]KXWO:_P":]?I2E*?3ZUPR M9Q`5I5<"2&A2HT,UZMQ(0G(HMY0?JW^S[G:O':M^:U%KV^WC[O8JT:L,_:Q] MF]_6WKS-*5C]W6V,4)@EDX@5AS>4J41Y?\P^ M(3KMNC=H]O#WV&'MX^OU*3P1&L%#U9<6F7G;[K!42@@CT*RUT^K'?OL,3;=^ M&\A?1ISQW;O@]>_W6K+'9L]G#*V5\<;;N?S*:SA=N_X5J@G&ZV^ M",N53[[2F^';XLJ12+S>_P"(4:-'N1:=5L]]NU:?9]YLPPO]Q1]LH(2L',.Y ML"BV6*?+$83<(8>1OBKROBEO9"L7:%=[*WI7+DS@8+ M@CV&"HT5K(+M`Q#F27)$&*PBJOE9,@2W6;M%E"Y1?#.VA'IOFIW7QRMKU97Q MR].">LAL*-A>HY(;U:3%"[U>H?I+O)RA&L+VK]]LKZ$6HB>7CT>Q7NMAG?4E MPWY;]EL]LGQ7(LT5B."M-D@R3668K;;]5TF22^KW]E5E/M^XNFOH M]-V*BVSW.6F]MML[Z[VRK&Q;^8YS%;F&>+6+8#469(AF,<84A@A'Z[7RV+EF M2-=OQ2(\,<;WS5*+ZT^-K7]K9:LD1KD1%(F7H%:9:B6)]*M*K2*-*I*I2J-> M.Y.I3J-&>S3NT;]66.S3NU9YZMNO*V>O/+&]KW^BV>%[>U;/&^/KZ>MLK7MZ M_AZ^OIZ_JI[>'RM[>/K?T]/Z5OGZV];>GS^?K;YV]/K;Y_2GMX>S[7MX^S]/ M:]JWL^OX>OKZ?]:7SPMZ>N6-O:_J^N5K>U_=ZW^?UM]/QKS[6-KVQOE;VKV] M;8^MO6]OQM;ZWM3VL?\`O8_6]OK;ZV^MO[[?GM6/*7>U$9H`W%CE;Z5P.K48 MW-D$I-#-!EQ:6_JT[SNT$+VJ\%QC6%T*-&XML&IU6`W5NT[%M]&&W#++(+9X M7M>]L\;VQ_K7ME:]K?WW]?2W[:^!67%#]H_0N)#T>XLL^SQ>I6M2IMA%??3M M461(->_;KS6*[Z-&[=9,FQV[_=:MNWW?L:\\L>1I2E*56[/DH]=R+&#Y,>_!#5!S[;9`+G)^"POP#AVE1P_X5TD_CQB1& M3W72;UFQ"FT]]\_F\_\`D*\`?_7ZES^$*JK_`"SOSRG/.)^50$[\8\1B6PM\ MD7!&L".`=>2'(J1Y/K*=1>#-83P!G^70`]$P7D9RT`WFX;J"ZD$#5*5B9IN? M+VD./V^1".>\$/`W;:UX^*GQ7QTT4G)W0ZESR!'<]$33_9+>TQ6ZMIEVLD1L MXV:V!9V-T=BH+MX=L]-?8D!<[0N-0H@6;"4P?T*\9N4N`BI4D M]9Y.XDSHAN+,&\G'I]8G8-4(]QG,CM6+-6[4CQ2:\]_3#Z+[`?F_R;R!YCF_ M#?1SD@_D7N:,.5PO0X(`*7\M".#H_&/3G?JU(M.X/34Z5[N>4TRY^7[5((8^ M,M+7H&(;;CR!7AOQO+1]]/=\OJ?W(Z&SY`IV83.=/\H9=OB8;D=M%O00N8C/ MYGD2'L7MD]6MD8BXJ6*2PV\MJ7.,':ZB[G#-7+#05_)TUM4+<%NO7#Y2^_\` MD_G:/IL=$TR5/+512;Y4_&=94::S-7FW/TQ%IQS;O'O*;J^P&NBVJWVXC8(K M'#Q(I+(0A46/&$2H5>7S7F-F-3FFER)7QY8&_+CL'RC-;:._R7UJ2R_'>UV4 MY=3WD':XE2.071M`$F\H:R500<6PHH"*1X5*I!Z;(]PE0F6:++,I-M#KKNE# MU&U)R*]DRLXF&7_E),^>*U'S*1;\5IH20`QBH'\)(%\R>8*75;@Y35#RJ.(&V]79'UTC@7"];D1`=C>6&M3E31)Z@\R?:RWF_FR4@79CSC.:8]\94#](.1M MH75SI"3%E*:'I*[N`W=!-LOIMOV0^N";Q:C13(7!"$3L2.6;'JK21U'\R6UQ)AS6U.>(9;#.BU0R@9KH2,>:'0YW<0. M'&H:.G](+:Z3.;+#DEBQ&AWGSBM6J(65(]:+%)5GSR$8DB"X>*O*=U09\KC<1L7IYY2LP94ZS\@$'VYD?;V@4<@UM2"8XDXA#S M3;W*;&"N69X:4H)`8@1MB)DDR7!KLG38IV+$<5@-!`MHW:6$>4'JUH<&/.>H M>\I;MZ9ZBDODUCRSTQ!1F'FB]$O"CO>'4+*C5_2&UWDU&B-:G/6B*62Z#K7^ MY*9ASG(F52'5,XW1J:(3!+KD3'_DQZ;BIC125-]NM]]\Q,GS-<>PD[>C#\U0 M?/Q0=RY*T&28[)EC?HOIN,HV9O/9D`%?0QGFT3^9.Q&6:(1Q(FP]'&'6C]** MM3.?J!Y=@O+A[H>1^SW,DBAC?RDSJ"%(=?P$I#@*/$D&(FJ6+0<42.`]'ZU` MOV)&YKVL)GDC2U8A-M&2#^LD@,N):`.B<8@+KJ1P7(?C0C"0NWUGC"YU?D=^ M6V9'9/\`%;3B6.43JGJ&.PY2%1A#6A*18BEFXI1`E9N>A:,&Z)'.^:-V_>WM M2Q0[C@4IH_'O'RY]5LF3@CMBON5^XN6!8=\:Q9:SBH6&^2XUE]T]";FJYY,= MV?)TL"'YT?T2FDY@NM*;+APBB$6SS.D3K=2UPN-4C1Z2?UN+H6>H28713<@[ MH0/#8B0/Y0)Y<%$ALX9T)&?(TKS0TV.1::L.V(IZJGF.GWS]&I%NF#*-TFVW M(RYMF)20I4+=:2Q9;`_DB[.'B@[T8/5G+W-0=P30X9`Z/=O-^4V.$5)[(;<: M2ZY8Y%RP\(7TRT<9K%7&F#^3YYXM!<)#NMH&LP+VP3ZG8+&"$IJPM#U]XQ?/ M06'4$K<[P?T9(O-`;J_^4H^12,)A>T4"X]7/E9'S;XXB!^9#6XMD1G/<,`._ M$B5&(1QX!5>X"35Z#.2(EF/T(L_Q%^0#I)[07XUH[Z5\CKWX_B=Y.SRGM.<. MWANN-&@^WR[>,7\69G-K(=#\=C3+L,0?<(=/O/N0(G#H#$U[PEVV%M@YUFE= ML[-_!773`G&+XCCHGT,`G#HI'S7$4T2`1T1>YH1'<*YN@R9?!(C*FT8(RJ%HMVY:G%+]NG%+MJL^^?S M>>E__@*\`>OLW]/_`(?,N?UO3Y6]/YH=K?UOE_6M\OSVJQ6:3L_`X9-FX&CV M-Y`G70C;N8!A2+(YJ.X\(+E)43I<^@C((9E/,P.3BP^XTM$J-+.69EER)`A4 M:1VI=M5I.MUVU(7E"[">3?VHQPK[4/#9D\@]`]RMGF]Z\>L) MB13/_;?CYF@9S3+&$^RRX8/%R/SEL:Y9P\U]/HCS7CN5B"\C+46:F4C6#U@W M7@0>P&3MRDJF5!=:)7+N$I1\K9V4F>)GWDCCB/8@6KEFM[/*-^PY(D=[`D&` MDCN1*`#*-4;S.L8B4)U;H$X:$*I4MPV[MJ7!-NW?U2\^W&EFPK-LGNOL M2W7151?RCJ+Q\Y\R\-0FXC!ML!YE\K/#L5GG`TUN:-R-P?(1E\M1>=;1#'W6 MU.]`A(F3;1^U0YQ>K1@C">^O@O M,2))SWQWY;/%--0'LSBV+7;Q_%G845DY`C%([N@!H-*WHYA;MI\HF&PY*/#W MI&9.8&7J>!UO@GX'(910X7[O*H@%DZCW.+AG3$`.+O*9&S!97C7>QMT>%"<' M2OZ6\3[HD%IP9O9[1+@Q[19O4/-JA0LBME=).)85(&A+J0++/I(/3EP*U+=( M:):0\CX\G3QX.01H798/G-K;(.9LQ M*`.&+0(30\.IM20,U!&&[)Z[RRA1D6T9;LQE[Q5XG?W9_+V71+0'1)UC#G0W MED\:W3$K-AW2>V1H4I,GD[CW&6IZT&^:]P%ZNY3I3'(+EU,!9J4X/9KW4O5M MMK3J`[%NS3OONEHS3XOFS)G@0CKQI`V4U^YCDW\K$YFE2.+,H(]#$5N0:>9? M94-=ANG4;1R&7EDTLT*R^]FR8`^,+*MB1;QE_.,N(_FKX]OXOAO9Z;RM@]<,XQVN2\#8FL6!A(=L=?Q5R5V M[[:WX_"\(B717/T:LOB&%>)NEN@/'=XJNE.T>ZDLD=?&RK2:`)N$XS:(ER1W M'G+$I2R.?,?P[S!-$DY/)9'I@R(0IBJAHNH<'3H=2DJF7Z3"=Q^0[HZ-(W$7 M[FF6/1;=\>WE.Z&"S%%+*B1F'NI4/&$S^$#B+RA-LRY&=$277 M`LYSCTXQXM>#4AH0$8:(.*BR[(*[T&MLN5"Y]^]=;(QD0L64JE._8+Y\CW2\ MR`"SG^ILO"Q\#^03JB(8!XPC>*N\=T5L&& M?$]RG-O/SB<\S1._8XZ0=)+N^>^Q'HX==FK&FIHI606W=9!9X MF,_?(0O;/1BJ0.=.:&ZZFRCWY\O MB&UTF]G('E-?CFX[:$TMEEL(`U$2I\[)FQ?9N;P^0\M.14OKQU[<0Z;:2XES MR'Y(DO/\9.)I\S\LE^DRKH*I)8C(SU$_`\5-%HZE+AP$&&;*::!21]XFEB1, MVMRT,28#;3(MY,KHU$E.`O1N73""KY"WO5W(7`W&R.82,,RM[*<`URKB3C.' MEUG%=^#SS=W@T2(".;^29KV;I%(:+[G#8J7NL1!OLE/8C_.TZ/O+7._)OG7G M\%=VO'FWK/R`^1CC_H%G#]FI:AB.9&K-8-R MCM8B9BQ'>FP2I]\>2J?)@DWL:0>OX6@SHF7Q?A@:?)3?AZ48D0MTGSTRY M#8*IL3WWEHG`JO>@8VCS(1&61Q6HT-EKO+'"[8SU'$[?2[=)K/)?**YN27?U M1VMTQ>3?'M/`:6N3>6YEW<]>2EJ/R)I36PIN@K\JX_4>*7IUGG]1CEO):<\V:9<$/OTJ[67'YTZFM([DF]O)U;7"G"X)'9Z%W`D0D%Z:RA1NUVA/ M-^WK_K;F;@;BMUP_UK.TV<.^-Q;TXX<832"S;ZB?KZ:UY+'@93T1B\7>S"H1 M-&\$,\:X#2?"Q]^(L7MEKV-%P*TQ%.EL"T]J<*=/]+,ON#RJ-R/9`Y\?_B/C MF4.0&',@EK'8-638TW$\4W=\6Q:!DY6.B@GU*CDAMCF<"&+RHU\+PZ9NI1JK M4E(-_=C8%X:'TGD'PJ=>$DE>14+R`&=A6Y-RL[E8?DZ_NJ8YW6H( M$B(90U[*#8U(!**/B!0K%#H1X7#7%[-M17&GC;EU5P]!O=:2!^3N78LB7Q"= MAJ7:]81>CO.SOW)LG+D-SMAK?S@&_:/V0T&VF;2GUDM?\:=D8C@\$0I(.)[- M%LMXO/.>>NNG.!.;F^V5O8,TNF+G5_)KHO[=9>LQ%T728NYEF!(_8D@6,T,# ML4:CC-"K9+5:'RGSBPN\W= MO6W\AGB$A)BS;NDWF?L-\,UL=NMJ;!4WA%DL1S&3;B)_H1[E9[<+:6>#%E4\ M;FTBIBX2*XE>DP64RDZVZ,\A4/S+Y`4+%\AT]HQ_CXZ`\14"1:"*-*"3+M"8GU-@]5&&!1ZG#1)P[WRB")#H!J(7CO)$+!]J=0)3`.'F+NOJ2(V MK)'&[M[NG3429/ESEGFUE]"N)Z\UP/);J@!A5'I^=(>Y)(]5^4-T\&-`?XZ^H)]: MW1C4:L<+_P"<[U5"W9LB06UF4YP)ABJ-G(\Z0XDB2*>9WZH]=_5[W>$P*7J;--!S-%SXZN?".A.UGGL3Z`BU3IV:S/*+-;\E7GGE'; MV6L%S\[O-UVCS3*S$"[(OU38U.2VWHF(3%N))H$V>6Q;8<`J_(I;.[2 MXC(7#3LWNA,-<(_"LS@Z9I'A*"?%N?AA\ZIWF6/8P_E);U&L%TMZ+WX[XYF: M*V/9U1U$()0*9J>0&59^JM3SF^&ENW_)$^8_X M)E)^L;S%ROU%(LE\P<*NZ0]Z.)XA=+@Y&Z4Z6EP.V'T"!]`D=L6P'!(%Q",G M6RG/^0.TLYI"VA+DWB'$\S]03#T@Z^%P4P33NGN_/'\H3V1'&<@D MY1CZ<7`IC17Q.]GB/%F9MB]B1DR9?L+/F'`G&O\`!,<./*:;[T8S<0#CQ>[5 MWI-/_FM7_H\/_5M7Z4I2E*5''J+DZ#.R8W11/T"UC#J9@Q[LR2!.AO/V0(S/ MAGS'I:QUF.8(\XQ<[0>(8JWR^.)!`I%G4F6"G#7LR]J^O#V83.+PF<#NX`<: MKK$]4N=L.<02`.1N.+R'>0$V!<`,PDVH2P8V&*=,*QI8431;]Z0@.()5"-:F MW;="G3MU;,\+VK!Q(\")&!!*>R08''HA8Y-;9MVV3H1R72B1Z+;=^>S=LMI3 M:-6OV]NS/9G[/M;,\L[Y97Y&E8[@T6M@$4-O!M@,&\JLILI!8!AF(=199ONJ M5X[Q>*6R#=BJ4WOO4VV)\K;]U[[=OM[+WROYUM%K:;:\=3;`:\=)G6X]5M84 M9A;4?U)\4FHWKMBDM;`OK2XXI]9/'T7X:,<=.*BVJUL+1.Z)X1A7IU\7\IY;D1--QHFW#LARNC5(2;4>$Q,M,#W?EZ18)U#=QL[WQ,;J1&U MI%43P+:ENY/>6:IJMI=M7[US?"+-Q3:)WD]RL0-4[2.\%L]Z%W+]FY+GFLVB M=O\`Q1FQ1ELS'[/Z:/+1E\Z\V:S:M?&]F^#M?`[L=&%["!UKX.3=[?O3^-[) M?Z)O9[S9[PM;T(Y^WG[2F_M9>OW[Q0Q4O0%%(Y"H)"L%>L80WHTVY:/P7Z]> MI=@A5[-62A'BLU:M>M5BFVZL5.O7AANMLQPQM;T4AA*Q>F**A@Y221)EB)(0 M4(4FY:E1D+:[+TJ=7MTYJ-"9;[G3\7HU;<-2GW6OW^&SV,?3#U<2Q:O7!B:Z M-V$L(MT*1;8!>K9C:4K0;>+X9:RP(.KW"\U`L,3UYY8$1:'8G0+<NSFG=&3'7;#>N@,V1V+HK@Q5TA2P].F2H+$4WPGN%UD25&D3I+*]>[X M;0F3Z='N]>C5CA^JIJ-A;F0V+&Z"5;"RD8M*9J0XW?F15A?=?8ZI?EN2YY+% M`KW.G[-WJ;[=R#W6OX3/3[O#V>$11?&PXV5.7D+&,:NQ#//8T<1-F[LRS7VLMSRS& MWRR66Q597OOQQV6R#%C,O$=K$8M)L6%:2>DUJ&6;X>P_473VPLG*:T5D5DN! M'1;7KMI7XZK*]5L,+8;L?9Q].+/Q5&3K"CFXYX\8SC;X@K8Z*!'F@W#`8:;Q MWJ%.)A`*(C%*!$5Q4*U6_$BE3ZEMMRC?MMO]YNVY9_J6C&.3Q_)U'&$RS#GR M!;&ODXRK4;Y(]DVMJK!;M;^1E<.4$L@>Q;JUJ]@FZJX_-5KP49)K[L<<[?DY M(JC)Y-Y:TG=';%=#5)%+'"+:<30;AQOKS-L[;;%EH4H,5C%9.VS''98@H2[% MEL\;96W^U\ZX49"4;")/2R^/;NE*]AD6HH7`JD^_>G$MJ-TC@LZ-S;;;=39Z M005.4,IQ"@QO1#]:LCI;C90;MUD`$!X+=1=6?UJ\!`W% M5K.+TMD*TQ@HQ2VW8%5B/&R141QSLM4)K63[M^>FUL*X%P19&;L`:VJZ(]8[ MD;&DM]O:FZ>:+=,@M1OXC>J^V-88D,4C<"OQ2E2HL1Q2V6VWJ-^[W_O-VW+/ M*4X0.D7[RJ44.3DU*1*/4$="%)J7J$**^5T:/>MUZ<56Y*EOGG=,GV;P%`V'8;;BMSJ%I\$+(7*#!Q+(ZX#&M1I&KLMN]!E?5;V M:-*^!>*&%;),28]"1Q0KDI-%BN1IEEDA)%G?-&O2V4ZMMDZU+GEEFF5Z;8*- M&5[Y:=N&5[WKBEK.:9)?F5(MEO+R>W:-W;"*T(+5+\]H?9GN$[>:2^G++*]_N4`0BHCI+J1`M043HE0Y.2W#T>U?H0+LK9K M46E;LT9*M217E:V2I-KVXZ%&5K7W:\[VM>L2;$1Q6RAIX.SHV8+4$NK=FI

S/7GM):5.S+7GGA?+V<\K7Y5.P&.D&$ M0J5G-9,'+WU7*B4[="Z!A.^B^.6FY`?J0X(UU].6&%]5U>C=?5?'&^N^-[6K MF%0$(MWBU*P0,5J`F^ZH/O4CT>_<*4WT?#74C=N[3GL0*+IO^!?C9L399Z]?&>C>/G2T]3#;@[6>*%M-=V@7H'$@#VX&7U" MT*4VW1^>"&XY0AUZ+J,-"73MV8[]>\@T51HWF\>:0-@,L2V75N(*G2!'-1OH M0SG5E].*^*O+;AZ8V_/=$<5J&'C%N^-F M#NC3#3@FQCS]\,?3AE\2Q:4LU;$HX89#\A2.PPROCF:VE?Y(%MN^RG:4:WQ`O M9^3I'8HQQW[%P;X)5GNQQW9;;[+6SK85*4KURQQSQRPSM;+'*U\U[7 MM>U[7M?UM>U[7O:]KVO:]KWM>U[7J#,=>,GQ[Q',]^AXRXRYO8DU8K5I-'(K M6B=IB'$)+$]J_<2,@-R4?BD;AHED37X$#(!(,*+=*K:G4*\]%\=6,Z/I]*4K M@-K5;.\<3$;F\#VBC2Q00,#=H<;L0%5ZK=K4*5I)%FER2KU:A1JU;]ZE7JW; M]V[7KV[-F6S#'*WNE;+=1)22%&"#)41C>K4E4B84@3I2:A?JMH7;R"?2GPTK M=RS3C;2KVJL-VQ3JM;7ORV86MC;%3D/Q0YMS74..,X^/[V1EIR9NXVRFN6VM M/)/GIVI\FSL("E.8#+1L3Z-FFXC)'[K9IU9X>SGKPRMSA%C,PN4P.%6FVB1G M5\+?66(`!"TGA=%E[:.^!%4BW+<;I<_Z::^.^U]&?]+5?#+YURR<('2+R)1* M*')B1>Z6Y4AH0I=*XE=#JOH1Y$%FK3@I6Y)--[ZDV2K;NNGUWOKTWPPO?&^' MN&(XK=K>T-)TQLP7(U4R_(JF;1]F-DRW]!//;MWY$=(0D+5"]*_+=OW;LEFM M)BIRV[=F>6V^6>=[\VWF,RVDB,#FLT6PVQ[@+$SYY"`;X@,C-G3>.K`R:+I1 MJ-+H)%BV.G3B3(K=>]8OQU:[*]VZVO"UN7T!A"83@!3BQV@)K0_9FL1I0I-0 MO`=?3=/\!@.UZ<4>"+W&5]'PF.BR?W-[ZO=^Q>^-<;N9K24:,DN]L-WVLM6:2^O)O[L,;8;@M\;B]N-K8YI,L;6M7#A8MC1MH MQ@YO1\QP0\+I%)PZ$,T6Z+1BDX+?N4A=`U,@&)]"#2(4*5&\7J28:!*MA94-6E,U(<:HS)+`U]=Q"I?EN2YY+5(N^G5 M<=O57V[D-]6NZ3/3[&/IPQ^,XZ=27:A<[#9;C1;G$@=VU(=:@`PEVNH5;788 MY=B&1-';7A9,KU6PQ]/E+1+%I_`+K.1PPC.MN'MSI;^ M!5FMHC@#L,H[@ M[_),MID'TWD:@<`>:YMA5;L"#U=MV*I"(2)A,M([3:Y"3,NA*U&^G<18B,3;T8U>3.:AV!5>M'I M%2E*A5JU>Y0D3*-^A/LUZMVS#+E4+.:8Q7K7CFRWD"[4L)D-2Q$$%I%>I<9U MZ=)=;K4IDFK?K5E-2?1K(J<-F.]=AIU8*MF['7KMCC"2&(B0-YTM%%%T=(VJ M^%2I:]&RE8S53-YW+5WL?&JW.$TB-8MP*EGN\/BE!=(MW;_8Q][GE[-O3G1S M`8PCX.PIFM098=N'*$%A[<"HK(MX@9<**W(_A4.KX;<-$99"A^W1[O8B&WN@ M39:DE[Z:RZE*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2 ME*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2 ME*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2 ME*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2__`(_]GUM_ MK5'?>?5?D9Y>@WJ:3\F-&#?9H25?LV&)58C$?4^'X^@A+%3[-K),E")&^L2J MKFR,H-AGL=*H^+),YBHI$PD%]Y;FLVRH,;M)'W1.N\/XWC@,7S9+,>=:3@KB M*59ZB9^.T@S$^W0SIU/!<8JC\X)2.1&7<&^*$UW@C>;K5*(=.ZG-'!!`^2R' M%RI(V/CROSW'#+.3D3CV,7/&\LZ.Y`7-D;H4SD;[V:KNY"EY+#+.72\_][I- M!'8WII*:S+I/I&JRV>1B@?I#`!ZJ1%"XB9'3ECWJ"51S#[M:TSE64OE3B?<2 M3%9-C./"XIF/,29YK:?0[8E)C M6N]1L=#%=J`)N49[U`1I/XF*:RP\7$;5#N39)*WF/YK8"Q.);09QOTH:7,Y( MREFYW0]%3)?=G#!C0Z/<-@$C3+([&9VA:QXHDN)"!42;)"B1IPRVQF\U$YK* MSO(M+"B?F=C)U9/9-`<2/24[@>QP\HYDF)8EN7!2Y!#^8/S8P*.(0XVI3;)%B.-SQ[S>XIO MS6/F($NJ$'=TVU&^Y6`!NS5TD7DJ3P%DKD!%G0\8H;+V`L)MN<`0=:W0K1O1 M$T=F\W>05]])]:1O'B*$GS%$$2=Q<]^I8\<;CMDYT0M.P:#<&+ MU4^88EK`8PR8WH31QJ$>+DF((QFPA?&;K:9@PVX_>KGB&TJ#62@DQN-DF23+ M0NW:(1%96\R]:)>B2\P,PI$TAPO)4*$V3J=K"D50S"*_(%*#*3R#'3B0&F"Y MW8W=^HTWM^Y*7#["6DPV7&*+B%Z;,%]N MEX">;[E"053IA;GKGAO1A&U<=[IR"Q?&3 MW/-+MP7S"_'@=2OR$$Z:,5G3D=PNCE?;S:]88#2QL%*R-)[ M5N*MC#EXQZGFX&QE]TQW?$D7-QU#%VO%T>L9K7<9Z0YUZA"\W ML95ID=W2NUPHX79QN0=KJE#<\$S"$, M/+<^W(5!B!AC6.B:O\Q29ONMJD'5S?(2*(3?,\MS-MT=LKO*1H1N8M" M*;DOHIP=?-@F=V.[E=L+(9*N\&P&ZRF?(BV6T\B*9/%Q"=89%MOQK!VU86\\ MW0=DDEG'-FXA,#2ZI![\2^1P=TW-L[P`N'[U0`,&<9AR#1VME M81)G.#==AU,Z0TD/@F?."-3<1`MQ=*I;AA4Y!#7')!ZLSBK@\BSI!>3C3R"K M(P^+B-$F;8T\9.[-HCEPL_!K-62TDF)Y0A$^KDT-'Y^3%C4F M=HS0J"PI&CC0;`P\C=^M M!UCAR1:'0HSI&(4+>79F.X7#6@]%\O'6Z>'<;M:3>C<6O'$?1F$DOLN%65+4 M597C_?,;U>X\.03/(,C?6H0I=J"+21T5H4'W4!P(.9#PC]\L#DVL.()::G.L MS1I$\@2A"3C;K_EIG-A:#F[E^1`4BN(DYHSVM.0"5F9):T*RT!X-'DK;&F]4 M;7S2SK;-=?F9CYK,Y\N?1RYTX\24`LR67WUZTF0BB$J:YC`0 M])DB0\UWJC*IQC M1&.UTN=:FR;[>!K#"X;I4PM8'F#B&>TS;T1MD1998K*O(=A>A9MA^:;O"&.H MYA3QDUBZO5%TX;],5.(BMMF,=S=?*[7(\09%P)XG&[OU*K",LMA[R^Q?)ZJ( M^6OR4810$2P M5G4RN38\+IDJP4O]QXA8M7@!F*;/,;F\PHT MY#/,SY=@_?U=SKSTN4KY#@K8I0CIFG)5Q<[)_.\4NZ8I*C\7$RB0T4P#M.#88KL#-61'.RP M<;.I\`][90.77@4:Y5P\<%\JCA=\S:N#.>`[X,F7(1]=V[ZGGR*,:" MY+D%G*8HE=[L:`P<3N?J*9&BF:-V9`3?FHJ2',M<6"F7.-?S_P!HP8*4/B0$ M4:-1S*&/'^Y"?5XD2"Y,!SUY#/>3W2!LTR&RG61 MZ,E\S`NGR+GSB7HN:(Z-16C8#.>+\&QK$''W)DZ/)Y''X'FA.UL`S))S0 M\I,LY6N.>&QY1*BUC\6TUW$!SN5WQ*?E*C]B2KL;X=NR0ZAR8W/<)M%C@V`W M%)3H#H:-9;Y&AL0#BY_+Y/%(6\-22CT8HBU?N>S30-I<;`OYS&GBRV[&6G>^ M=$#_`#,:([^^(?/\3&6S(8SJZ>HGC6'5[MA&,W$ABWGB*>='9(1T^_Y&F`/$ MSJ/?E#-2+%ACVN\]AV2QSM9^`5NH-`]VDP.[,_,?S[8WDZNGN88V:KO>4I?>@1 MBV,8Y0-EG-C:^K2.4;"^-G/L5@5V9TL=;"$K-('`1OSRS`:IT.(+`\O$NDV2Z2;TW'W$\I=>:>45KMDI\.+'7?6\% M[^*S6_W8_HV07V[&P4EASEGA%+=C9#K<2IF-QI`FK83 M$@=K`V>'"-!NCD`5&C,Z1RH@4)%B?'@^!>>6XF#I1R%UZM0*;X,Z"0>^=BK9 MEC(G/4'1[SU'*C;G=/C?:(T1S&382&!&7II,%=2\KNV:]J[9JPU4VO%9S1&\ M=Q@P(5,RS!A*(G+,S@94D1T]QZB2DR*?\/@Y2:1(O(#9?04VU309"TV^'3$V MTH+,<3'D=8L0RW%[,$+]7+%/&5`IYS!BAUY3:Y&:VDZG-MQ8[)%T/5J-MPK8 M,*<\KW4`=[R;K@G`(O)1N;*X&6V-EU-'AYW$B$AG622>Q%><5?C'_C0AN.2# M/5!Y4GY:%#`8.$OYJ+WVUT;9G?+;4@+!0P2V-SD+(API*DP`7XMN3': M%<&O4\I1?,.O!E=)MZ+HSQD\42B2&PG8@\P/G0M!E@0#051J7@,YG M4_$4=!70X@,8)VFWRZP;LG.Q8)CZ/)+EN5FUI)ZW=-&B.$SYVJRNQ8@W:XJ: MJEFM.PY!EKQUC,M(57MUK[Z\\_CE%\5&RV&6-L;PS>W+_'$U.)[Q*(FY2+DM M=U<@[+=36CJ9F.I?HN<6&RVPP4!,FR":)V>PWFHF;35-ZVNX6HM&!WH*".O* MRN1J.P$\)5GIX.QQVB37`$B,.1Q;I/%&\%;[<08)"$8,-NHVZT6LVFN,9;8&M@2%0(M M5\\OJ?\`Q1%KV%)_@G9(\?R`&GAW](-69F,X&\FE)F2:]PC@9;@6!2+G:CI: MRL"HC1S$8KQ;+G:+A#68FL6BVIMQ@**-I-'-CQD6MX(MMF>[W;I;;L8R*5U`IJ&9/"O!/K M3YJI&RKQQ"B-P[WLTL(EU"MXYQJ!PW7:%YO%]!,CXD;JTYZMV6F1 M0Z-22]K/'[2$X[!.RVO3LOLMQ3CYDAEKPS)L8ZGX^(D;TMS0[)E7OENR;^13 MQ"RY)52 MR'4`/.64U2]Q-CH`*\U:5SLEH%)+73K(D9R^XGLO0,F/VL)9STCV48FB]_QJ M:A8+&*=G.%JCMZP>72$3"4KSF_Q81!N+%9"PFKIM+T.Y2;QW//J9!(3/03H\ MFR^X\:T7.&.BRQ)&FJ-Q;`LSV.SM;="-&-FTJ8[G;J.0V.3;LB*BSI([=C;Q M^)*2&F:V8U&5(;(="@MM7*WA@1ZX MKAW(I)+]+V8;5>&)G(V.S4J=4//Q4\\/B:,YF)O&:.?Q76+2C81(B!!&< M?]0CQP@*MG1GC+M-0Z4KH<8$8L"N1L&'@:BTFF<;D6VC].:)8%$LBYGXYA>> M9`:TER`A<2ESLX4T0P7:*<*@6BUH63T+#?3@+!0BU:-FM1GJE&"F$J49Y98W M4@TY0)E;'04V[M<=96\5?/TGD7D90/F>XH-26MZ"TR>8B22$3:(R,R>GMC65 M2]%[F4EFFY+ZV.7)LX(9`9@,0;R8Y7$HJ9SO"V/G-9#GP_C4AUL+3F#.DWHE MCL\WJ(D_NX94J8M9I"I&+0RB@-3E]ALD5'P0([-C9$._E1 MZZ$15V*2=U!?CAAQW&\.:5^2A)[*T7K:L8-A$[!N[7?0Z=EB>Y;[G[2W88X> MV_%9SJ';[:9C@=D[20PX_31XWHL8;_E)01:T6QQ%V#U3LZ+&BC"A0"I2U4(Y M]E0BL^\%KKE$JWQS7;Y&1%`9K!$23$0'B(@UO"L_#[92<16.3HUTC7&[9%7G7`;VA(FWA55VYH3IA^K5[$0.O_$H\I372ZW><'N)BEC]5LF5&/TF?62&_P`( M\">N9)Q$/E-?631% M!R57IU8[=6-[9)O\>,()GR&=K,/RK&`%,VX-:CNBZ-7KH:T=R8'YKQV:(23O M31J!*7DDP90[+6!4IV$]&.A?363)&A)*1XM9-K$5KC7XK(1SWJRY24^A'$\T MI&#E+%D=R/-D&Y#CD3SS-22>8U;8UUKHSV+Y'0(7P/'Z2AR?_OC?)=N),`2E MW8I]JK8IV&1\<',Y1CKX\4B7?9M$8=["@S?HU/!;@JLP>XI*$RO.J74L^&RV MZR2YV!4.UKE/Z6]L#\-B%-@IPVY;+?$<\<,)GR\N?&O*;-$>S+LG`NY84%2' MK#16A?'1T>$XTF201(\6WTKL4'7@"/.,GBWW.\7+&S;>;A+/QIL($[]^DPFR M`YP#"A65&),PPO([3D"/7;`3K#&&XYQUM*JW/,=S7$S5;A4:>;IU`J;KDCKH M*3VL]M.G0D+E4IE(0$&&^:$CR6GC9Q\=T'SW);HD-TN"50(^3PL7MR>XQ93R M1`HQZ)!0RYE3HC<9+87>WB1U1I`J5RT,1WL=S,9:]6:INQGZJ<[1T)`Z?/73 MQ7"[LY]D7FY;B\1[&D>2Y`F5:7".Q8*>[:E5_P`\%>ELWZRW0GT>^;Y]HS.4 MP>;'SQ2*D0)2+%(=R,B-3;4JG4#+\8W/C=4E"[Q/RY-;L<[PFE\OEXS`]T)X MR_3\^P.PN;I&R<@]NMEIM32(71-&[5;XIMMMMM]O`;I-Z@6-T?$YZK<82\4_ M*JN(X;B`9JDQL#^?XS-QY$+R;LAD4TC,LF;EJ))VSE=([%R(CM(S`CEV%V:^ M]+T,HR."TOL<>@Z),"G,7'[^/%^+"'P2;(H#FGIX3*Q![S2]G5/262VSMEIY M;>AVK&S2F1OFE:V.U3'&MQX((?C%<@3,YBM!LPD+NF-8':?-P!`45F-Q`P5`*XJ9H@2X494 MHN).$EF1/DS&XL14J;ZA9?BKBYCZ5RT=T3U^3?%FG#D>-:3'%,#?..UDQK`Y MMZF(YC<>,61S]WSS8Z33(;O$N<#+S'DK1(:,II(R!FY7.)"N$=+GG7F9B\PM M`0PHW,O3-HA6PE`I&^>-(E07$OM>K_D)UOG0$%!PH40[W^ZY&-D';FWQXAM? M"(6X#;39;0!O#1FN15*4I2E*4I2E*4I2E*4I2E*4I2E*4I2OSVVO?5LM:WK> M^O.UK6^M[^S?Y50#'4%3P+!^3B4$8N-DPO'I3NYV,ME.OE%0[)B>>]7$"%$S M##+DX^^/LLB%*NA,@4@DNN'72-.CTRYIY;"NE=96DB-LZ-[F:#E?6B+C,R/" M:0/-1+&+X%;(0J%%L8@W>!62Y!FIY*TW0J!NN"&?:O=DVQ!#4_O9Q/R#H,FR0Y+8;GS%'G!&.V.7/S M%$#5C76D02+$D!]'NT(GG'KP9TPZVT@*L16+E!O1I#4=:SP:SJ4LN1,]=77W M9[:IHM'E)EN@"`)=,2CS3#QYSM=) MT$96EFD[0[#%6NX$;J@Y2ZGD$:J\&DC.&E[IN>CW'XSIY]]/Z.G,.M?%(]Q? M.PZ$CH:('#SFC9T&2/)DYO1$.C'("%/I9O,2J2E)X['2UU\:NUAMJ*KAVRUL M]H)T;8@AQ^0E/%;*DA.=GIL."(!GB=`L6!!49-Z-H?M-,W10T7@UHVPO'S2(@`+3Q-NMG)(Z'''.VP#?'-QS) MER]0\[.`WK)(";CA2OJ%VI$;OR[1MYG'O+]9#`/-$ MLE9'TVQFZU)(E8_S5&R3K-@LAM2#$$3.#FX%',:RCP=3);8:6NA-?1C M81E9Y4_P"5KZ'1VA="+<#G2^0! M\2>7WG9RZR9J1Z=2]IQ"X@D7#$S?8C4B"+.15LEPXLC?)7'11>WAROHMJ)KM MB3=Y0@YGJC/+XN(N9Q-TDG`:(X0#*73`'HW6ZUDB]6ANLIRG_P`;CH6?YJCB0N%>)0?;4J/=1G%Z%N:"+!P'2@I..-*^6[>#W]'#49P\&CWN->V7 M;SD23CY))1C\RAU3)++H[\'JWR#(EE/E!8Z%FF&W5U5"K,D)3'+99*_=,$8MAQM[<]YYDY@KG6GADHM&>_7G-$BC6^ MMP<+B1LQYXS",*O$5TCXDY7/,J=@+IT>.N98\E@')#]D5_#8N.H&!Q[82V72 MC)J=,=MJ3BA5`Y$[I=XYIM%WR.3!KK'[KL&]H'B+G&6\P$@-H:[FQM);P9:R MRZ+:6`.!KD,O@2"L6I^(!ND6%.H?96(5&.KXX:F^)T6U+$WOD:E,HW932E*4 MI2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*5^>7]7_`.=? M_7*O-OZ^?]V'_P!ZM>3#_P#%+*'_`.[M[_\`^L%*A'X@O[,;AG_#?'O_`/C< M:L@P_J8_\N/^EJ9_U;_L_P!;5XQ_K[/[\?\`U;5[6^N7]_\`]EJ_)1_YG;_Z M/9__`&\ZZOO@N_\`CE#?_P`+ODW_`'PGZNT+G],?^?#_`%M7I^?7_P#._P#6 MQKSE]=G_`"7_`-+5^F/TM_=;_2E_I^W'_6U>F/\`^C_]'?\`^Y7M?^OC_P`N M7^N%,/ZF/_+C_I:O:E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4I2E*4 $I7__V3\_ ` end -----END PRIVACY-ENHANCED MESSAGE-----