UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
x | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Fiscal Year Ended December 31, 2011
OR
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Transition period from to .
Commission file number: 001-32836
MEDIVATION, INC.
(Exact name of Registrant as specified in its charter)
Delaware | 13-3863260 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
201 Spear Street, 3rd Floor
San Francisco, California 94105
(Address of principal executive offices) (Zip Code)
Registrants telephone number, including area code: (415) 543-3470
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class |
Name of Each Exchange on Which Registered | |
Common Stock, par value $0.01 per share |
The NASDAQ Stock Market LLC |
Securities registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES x NO ¨
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 ¨ NO x
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. YES x NO ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). YES x NO ¨
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained to the best of registrants knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. x
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 the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large accelerated filer x Accelerated filer ¨
Non-accelerated filer (Do not check if a smaller reporting company) ¨ Smaller reporting company ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act.). YES ¨ NO x
The aggregate market value of the voting stock held by non-affiliates of the registrant was approximately $712,838,841 as of June 30, 2011, based upon the closing sale price on The NASDAQ Global Market reported on June 30, 2011. Excludes an aggregate of 1,643,149 shares of the registrants common stock held by officers, directors and affiliated stockholders. For purposes of determining whether a stockholder was an affiliate of the registrant at June 30, 2011, the registrant assumed that a stockholder was an affiliate of the registrant at June 30, 2011 if such stockholder (i) beneficially owned 10% or more of the registrants common stock, as determined based on public filings, and/or (ii) was an executive officer or director or was affiliated with an executive officer or director of the registrant at June 30, 2011. Exclusion of such shares should not be construed to indicate that any such person possesses the power, direct or indirect, to direct or cause the direction of the management or policies of the registrant or that such person is controlled by or under common control with the registrant.
There were 36,014,735 shares of Registrants Common Stock, par value $0.01 per share, issued and outstanding as of February 22, 2012.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrants definitive Proxy Statement for the 2012 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than 120 days after the end of the fiscal year covered by this Form 10-K are incorporated by reference in Part III, Items 10-14 of this Form 10-K.
MEDIVATION, INC.
2011 ANNUAL REPORT ON FORM 10-K
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PART I |
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Item 1. |
BUSINESS | 2 | ||||
Item 1A. |
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Item 1B. |
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Item 2. |
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Item 3. |
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Item 4. |
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PART II |
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Item 5. |
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Item 6. |
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Item 7. |
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
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Item 7A. |
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Item 8. |
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Item 9. |
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE |
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Item 9A. |
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Item 9B. |
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PART III |
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Item 10. |
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Item 11. |
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Item 12. |
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS |
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Item 13. |
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS , AND DIRECTOR INDEPENDENCE |
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Item 14. |
PRINCIPAL ACCOUNTING FEES AND SERVICES | 55 | ||||
PART IV |
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Item 15. |
EXHIBITS, FINANCIAL STATEMENT SCHEDULES | 56 | ||||
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FINANCIAL STATEMENTS |
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REPORT OF PRICEWATERHOUSECOOPERS LLP, INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM |
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FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K, or Annual Report, includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this Annual Report, including statements regarding our anticipated future clinical and regulatory events, future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. Forward looking statements are generally written in the future tense and/or are preceded by words such as may, will, should, forecast, could, expect, suggest, believe, estimate, continue, anticipate, intend, plan, or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. Such forward-looking statements include, without limitation, statements regarding the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaborations. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including without limitation the risks described in Risk Factors in Part I, Item 1A of this Annual Report. These risks are not exhaustive. Other sections of this Annual Report include additional factors that could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. We assume no obligation to update or supplement forward-looking statements.
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PART I
Item 1. | Business. |
Overview
We are a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Together with our collaboration partner Astellas Pharma Inc., or Astellas, we are developing MDV3100 for multiple stages of advanced prostate cancer. We have successfully completed a Phase 3 trial in the latest stage patientsthose who have failed docetaxel-based chemotherapyand we are conducting an additional Phase 3 trial and two Phase 2 trials in men with earlier stages of advanced prostate cancer. Based on the positive results of the AFFIRM trial, we have exercised our right under our collaboration agreement with Astellas to co-promote MDV3100 in the U.S., should it receive marketing approval. We and Astellas expect to file applications for marketing approval for MDV3100 both in the U.S. and in Europe in 2012. MDV3100 has received Fast Track designation from the U.S. Food and Drug Administration, or FDA, for the post-docetaxel indication.
We have not generated any revenue from product sales to date, and we may never generate any revenue from product sales. We have funded our operations primarily through private and public offerings of our common stock and from the up-front, development milestone and cost-sharing payments from Astellas and from our former collaboration partner Pfizer, Inc., or Pfizer. We have incurred cumulative net losses of $250.3 million through December 31, 2011, and we expect to incur substantial additional losses for the foreseeable future as we pursue regulatory approval for, and, if approved, commercial launch of, MDV3100 and continue to finance clinical and preclinical studies of our existing and potential future product candidates and our corporate overhead costs.
We are a corporation formed in Delaware in October 1995, under our former name Orion Acquisition Corp. II, to identify and consummate a business combination. Our three subsidiaries are Medivation Prostate Therapeutics, Inc., or MPT, Medivation Neurology, Inc., or MNI, and Medivation Technologies, Inc., or MTI. MPT holds our MDV300 series technology, which is in development for the treatment of advanced prostate cancer under our collaboration agreement with Astellas, and MTI holds our earlier stage technologies. MNI holds our dimebon technology, which previously was in development for the treatment of Alzheimers disease and Huntington disease under our former collaboration agreement with Pfizer. As discussed elsewhere in this Annual Report, in January 2012, Pfizer exercised its right to terminate the collaboration agreement and we and Pfizer discontinued development of dimebon for all indications.
Our MDV300 Series Prostate Cancer Program
We have obtained an exclusive, worldwide commercial license to a series of novel small molecules, referred to as the MDV300 series compounds. Our lead development candidate from the MDV300 series is a molecule we refer to as MDV3100, which is in Phase 3 development for a type of advanced prostate cancer known as castration-resistant prostate cancer, or CRPC. We are conducting this program in collaboration with Astellas.
Prostate Cancer Statistics
According to the American Cancer Society, prostate cancer is the most commonly diagnosed cancer among men in the United States, other than skin cancer. The American Cancer Society estimates that approximately 241,000 new cases of prostate cancer were diagnosed, and approximately 34,000 men died of prostate cancer, in the United States alone during 2011. Prostate cancer is thus the second-leading cause of cancer death in men in the United States, after lung cancer. According to the American Cancer Society, about 1 in 6 men will be diagnosed with prostate cancer during his lifetime and about 1 in 36 men will die of prostate cancer.
Advanced Prostate Cancer
Prostate cancer is frequently diagnosed at a stage where it is believed to be confined to the prostate gland and its immediate surroundingsi.e., it has not yet metastasized to other areas of the body. Prostate cancer
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detected at this stage generally is treated either with prostatectomy (surgical removal of the prostate gland) or with radiation. For most men, these procedures are successful in curing the disease. However, for some men, these procedures are not curative and their prostate cancer continues to spread. This disease progression is typically detected by rising levels of serum prostate specific antigen, or PSA. Men whose disease continues to progress following surgery or radiation are considered to have advanced prostate cancer.
Treatment of Advanced Prostate Cancer
The Testosterone Signaling Pathway. Prostate cancer is fueled by the male sex hormone testosterone. Testosterone is produced primarily in the testes, although lesser amounts of testosterone are also produced in the adrenal glands and in prostate cancer tumors themselves. In order to fuel prostate cancer growth, testosterone must first bind to its receptor, known as the androgen receptor, which is located predominantly in the cytoplasm of prostate cancer cells (the area within the cell membrane but outside the nucleus). Once binding has occurred, the bound testosterone/androgen receptor complex must then pass from the cytoplasm into the nucleus of the cell, a process known as nuclear translocation. Finally, once inside the nucleus, the bound complex must then bind to and activate DNA, which triggers cell growth and thus tumor progression.
Established Hormonal Therapies. Because testosterone is the primary fuel of prostate cancer growth, first-line medical therapy for advanced prostate cancer typically entails treatment with a class of drug known as luteinizing hormone releasing hormone, or LHRH, analogs, which reduce testosterone to castrate levelsi.e., the levels that would be achieved following surgical castration. Patients treated with LHRH analogs typically remain on those drugs for the remainder of their lives, in order to keep testosterone levels suppressed to castrate levels. Estimated sales of LHRH analog drugs in the United States, United Kingdom, France, Germany, Italy, Spain and Japan, or the G7 countries, were approximately $2.6 billion in 2009 according to Decision Resources. Another class of marketed hormonal drugs, known as anti-androgens, block the ability of testosterone to bind its receptor, the androgen receptor. These drugs are often added on to LHRH analog treatment as second-line therapy for advanced prostate cancer. In some cases, advanced prostate cancer patients are started on both an LHRH analog and an anti-androgen simultaneously, a treatment regimen known as combined androgen blockade. Casodex® (bicalutamide), sold by AstraZeneca PLC, is the largest selling anti-androgen drug, with global annual sales of approximately $580 million in 2010 according to the public disclosures of AstraZeneca PLC. Generic versions of bicalutamide are now available.
Most advanced prostate cancer initially responds to these hormonal therapies. However, according to a study published in the October 7, 2004 issue of The New England Journal of Medicine, virtually all advanced prostate cancer undergoes changes in a median of 18-24 months after initiation of hormonal therapy that allows the cancer to continue to grow despite the reduction of testosterone to very low (i.e., castrate) levels. Prostate cancer that has reached this state is known as CRPC. The development of CRPC following initiation of hormonal therapy is generally determined based on either rising levels of PSA or documented disease progression as evidenced by imaging tests or clinical symptoms. Due to biological changes that have occurred in CRPC, drugs such as bicalutamide that initially decrease androgen receptor signaling and inhibit prostate cancer growth may have precisely the opposite effect and start to fuel the growth of CRPC.
Chemotherapies. It was previously believed that prostate cancers that had entered the CRPC state would no longer respond to hormonal therapies. Thus, the next line of treatment for these patients has typically been chemotherapy. The primary chemotherapy for CRPC patients is Taxotere® (docetaxel), which has been shown in clinical studies to prolong survival by approximately 10 weeks. However, docetaxel is an infused cytotoxic chemotherapy, and thus entails an increased risk of serious adverse effects, including fluid retention, liver toxicity, low white blood cell counts, and death. Nonetheless, according to Decision Resources, sales of Taxotere for the treatment of prostate cancer in the G7 countries were $629 million in 2009. In 2010, the FDA approved a new second-line chemotherapy, Jevtana® (cabazitaxel), for use in CRPC patients who had previously failed docetaxel treatment. Jevtana (cabazitaxel) was shown in clinical studies to prolong median survival by approximately 10 weeks, but like docetaxel is an infused cytotoxic chemotherapy that entails increased risk of death and other serious adverse events.
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Prostate Cancer Vaccines. In 2010, the FDA approved the first vaccine for CRPC. Prostate cancer vaccines operate by enhancing the ability of the bodys immune system to attack and destroy prostate cancer cells. This agent, Provenge® (sipuleucel-T), was approved based on data demonstrating a median overall survival advantage of approximately four months in CRPC patients, the large majority of whom had not previously undergone chemotherapy.
Novel Hormonal Therapies. In April 2011, Zytiga (abiraterone acetate) was approved by the FDA for use in combination with the steroid prednisone to treat CRPC patients who had previously failed docetaxel-based chemotherapy. Zytiga (abiraterone acetate) operates by reducing production of testosterone in the adrenal glands, a secondary source of testosterone production in the body. Zytiga (abiraterone acetate) demonstrated an overall survival advantage of approximately four months in post-docetaxel CRPC patients and that prostate cancers that continue to grow despite testosterone having been reduced to castrate levels remain responsive to hormonal therapies.
MDV3100
MDV3100 is an investigational agent that is the first in a new class of medicines called androgen receptor signaling inhibitors.
Mechanism of Action
While MDV3100, like all other hormonal therapies for prostate cancer, operates through the testosterone signaling pathway, it does so in a manner that is distinct from that of currently approved drugs. An article published in May 2009 in Science described the novel mechanism of action of MDV3100. In the Science article, researchers using various preclinical models of CRPC provided evidence that MDV3100 inhibits 1) testosterone binding to androgen receptors; 2) nuclear translocation of androgen receptors; and 3) DNA binding and activation by androgen receptors. This preclinical research also found that, by interfering with testosterone signaling in these three distinct ways, MDV3100 induces the death of CRPC cells.
Completed Clinical Trials
Phase 3 AFFIRM Trial
In November 2011, we reported positive results from a planned interim analysis of the AFFIRM trial, a randomized, double-blind Phase 3 trial evaluating MDV3100 (160 mg once daily) versus placebo in 1,199 patients with advanced prostate cancer who had previously failed docetaxel-based chemotherapy. The primary endpoint of the AFFIRM trial was overall survival. The Independent Data Monitoring Committee, or IDMC, overseeing the AFFIRM trial determined that MDV3100 demonstrated a clinically meaningful and statistically significant (p<0.0001) improvement in overall survival compared to placebo, and as a result recommended that the study be stopped early and men who received placebo be offered MDV3100. The IDMC informed us that 1) MDV3100 produced a 4.8-month advantage in median survival compared to placebo; 2) the estimated median survival for men treated with MDV3100 was 18.4 months compared to 13.6 months for men treated with placebo; and 3) MDV3100 provided a 37% reduction in risk of death compared to placebo (hazard ratio = 0.631). The IDMC further determined, considering the observed safety profile, that MDV3100 demonstrated a favorable risk-to-benefit ratio sufficient to stop the study.
In February 2012, we reported further results from the AFFIRM trial at the American Society of Clinical Oncologys 2012 Genitourinary Cancers Symposium, or ASCO GU. In addition to confirming the results reported in November 2011, we reported that MDV3100 had achieved all of the trials secondary endpoints with strong statistical significance and was well tolerated. As compared to patients taking placebo, MDV3100 patients in the AFFIRM trial experienced longer median radiographic progression-free survival (8.3 versus 2.9 months; p<0.0001; hazard ratio = 0.404), a higher soft tissue response rate (28.9% versus 3.8%; p<0.0001), and longer
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median time to PSA progression (8.3 versus 3.0 months; p<0.0001; hazard ratio = 0.249). PSA declines of 50% or greater were more common in the MDV3100 group than in the placebo group (54.0% versus 1.5%; p<0.0001), as were PSA declines of 90% or greater (24.8% versus 0.9%; p<0.0001).
MDV3100 was well tolerated in the AFFIRM trial. Common side effects included fatigue, diarrhea and hot flush. Serious adverse events, adverse events causing patients to stop treatment, and adverse events causing death all were lower in the MDV3100 group than in the placebo group. Serious side effects of interest were fatigue (6.3% in the MDV3100 group versus 7.3% in the placebo group), cardiac disorders (0.9% versus 2.0%) including myocardial infarction (0.3% versus 0.5%), seizure (0.6% versus 0.0%) and liver function test abnormalities (0.4% versus 0.8%). The period during which AFFIRM patients were followed for safety issues was more than twice as long for MDV3100 patients (9.3 months) as compared to placebo patients (4.0 months).
The FDA has granted Fast Track designation for the development of MDV3100 in the post-chemotherapy indication, a designation that is reserved for development programs that the FDA determines to be for a life-threatening condition with unmet medical need. Receipt of Fast Track designation enables us to request that the FDA grant us priority review for our anticipated new drug application, or NDA, in post-chemotherapy patients. In considering requests for priority review, the FDA applies the same standard it uses to award Fast Track designation. We plan to hold a pre-NDA meeting with the FDA in early 2012. We and Astellas expect to file both a NDA with the FDA and a marketing authorization application, or MAA, with the European Medicines Agency in 2012 seeking approval to market MDV3100 for post-docetaxel advanced prostate cancer in the U.S. and Europe, respectively.
Based on the positive results from the AFFIRM trial, we elected to exercise our right under the Astellas Collaboration Agreement to co-promote MDV3100 in the U.S. market. Should MDV3100 receive marketing approval, we will provide 50% of the sales and medical affairs support for MDV3100 in the U.S. market.
Phase 1-2 Trial
In December 2008, we completed enrollment in an open-label Phase 1-2 clinical trial of MDV3100 in patients with CRPC. We enrolled 140 patients in seven dose groups, ranging from 30 mg/day to 600 mg/day. Of the 140 patients, 75 had previously failed docetaxel-based chemotherapy and 65 were chemotherapy-naïve. All 140 patients also had failed at least one line of prior hormonal therapy. The trial endpoints included safety, tolerability, pharmacokinetics, circulating tumor cell, or CTC, counts, PSA levels, radiographic change in soft tissue and bony metastases, and time to progression.
Data from this trial were published in The Lancet in 2010. These data showed that MDV3100 consistently demonstrated anti-tumor activity across endpoints, as evaluated by reductions in PSA levels, radiographic findings and CTC counts. This activity was consistently stronger in the earlier stage (i.e. chemotherapy naïve) as compared to the later stage (i.e., post-chemotherapy) patients. Key efficacy data as reported in The Lancet were as follows:
Chemotherapy-Naïve Patients | Post-Chemotherapy Patients | |||
PSA decline > 50% from baseline |
62% | 51% | ||
Radiographic control: soft-tissue lesions (partial response or stable disease) |
80% | 65% | ||
Radiographic control: bony lesions (stable disease) |
63% | 51% | ||
CTC conversion from poor prognosis to good prognosis |
75% | 37% |
In February 2011, we presented new long-term follow-up data covering all 140 patients enrolled in the trial at 2011 ASCO GU. PSA progression data reported at 2011 ASCO GU were calculated using three distinct
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reporting criteria: the criteria specified in the Phase 1-2 trial protocol; the most recent published PSA reporting consensus criteria (the Prostate Cancer Clinical Trials Working Group 2, or PCWG2, criteria); and an older commonly used reporting method (the Prostate-Specific Antigen Working Group 1, or PSAWG1, criteria). Key efficacy data as presented at 2011 ASCO GU were as follows:
Chemotherapy-Naïve Patients |
Post-Chemotherapy Patients | |||
Median time to PSA progression (per protocol criteria) |
Not reached | 316 days (45 weeks) | ||
Median time to PSA progression (per PCWG2 criteria) |
281 days (40 weeks) | 148 days (21 weeks) | ||
Median time to PSA progression (per PSAWG1 criteria) |
420 days (60 weeks)* 812 days (116 weeks)** |
166 days (24 weeks) | ||
Median time to radiographic progression |
394 days (56 weeks) | 173 days (25 weeks) |
* | All chemotherapy-naïve patients |
** | Subpopulation of chemotherapy-naïve patients who were also ketoconazole-naïve |
MDV3100 was well tolerated in this trial at doses up to and including 240 mg/day. The most frequently reported adverse event was fatigue. Seizures were observed in two patients, one each at doses of 600 and 360 mg/day. Both patients were taking concomitant medications that can cause seizures. A possible but unwitnessed seizure was reported in a patient taking a dose of 480 mg/day.
Ongoing Clinical Trials
Phase 3 PREVAIL Trial
PREVAIL is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating MDV3100 (160 mg once daily) versus placebo in approximately 1,700 patients with advanced prostate cancer who have not previously been treated with chemotherapy. The co-primary endpoints are progression-free survival and overall survival. We began enrollment in the PREVAIL trial in September 2010.
Phase 2 TERRAIN Trial
TERRAIN is a randomized, double-blind Phase 2 trial evaluating MDV3100 versus bicalutamide, the leading marketed anti-androgen drug, in approximately 370 advanced prostate cancer patients who have progressed following medical castration with an LHRH analog drug or surgical castration. The primary endpoint is progression-free survival. We began enrollment in the TERRAIN trial in March 2011.
Phase 2 Hormone-Naïve Trial
In May 2011, we initiated a Phase 2 trial evaluating MDV3100 in approximately 60 patients with advanced prostate cancer who have not had any previous hormonal treatment. This is the first trial to examine the effects of MDV3100 in the earlier-stage population of advanced prostate cancer patients who have not yet undergone medical or surgical castration. The primary endpoint in the trial is PSA response.
The Astellas Collaboration Agreement
Our global development and commercialization agreement with Astellas, or the Astellas Collaboration Agreement, became effective in October 2009. Under the Astellas Collaboration Agreement, we and Astellas agreed to collaborate on the development of MDV3100 for the United States market, including associated regulatory filings with the FDA. In addition, if approved by the FDA, following such approval and the launch of MDV3100 in the United States, we and Astellas will co-promote MDV3100 in the United States. Astellas is responsible for development of, seeking regulatory approval for, and commercialization of MDV3100 outside the
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United States. Astellas will be responsible for commercial manufacture of MDV3100 on a global basis. Both we and Astellas have agreed not to commercialize certain other products having a similar mechanism of action as MDV3100 for the treatment of specified indications for a specified time period, subject to certain exceptions.
We and Astellas share equally the costs of developing and commercializing MDV3100 for the United States market (subject to the exceptions noted below), and we and Astellas will share equally profits (or losses) resulting from the commercialization of MDV3100 in the United States. Costs of clinical trials supporting development in both the United States and in either Europe or Japan are borne two-thirds by Astellas and one-third by us. Both we and Astellas will be responsible for all costs incurred in fielding and supporting our respective MDV3100 sales forces, and each of us will be entitled to receive a fee for each detail made by our respective sales forces. Outside the United States, Astellas will bear all development and commercialization costs and will pay us tiered, double-digit royalties on the aggregate net sales of MDV3100.
The agreement establishes several joint committees consisting of an equal number of representatives from both parties that operate by consensus to oversee the collaboration. In the event that a joint committee is unable to reach consensus on a particular issue, then, depending on the issue, a dispute may be decided at the joint committee level by the party with the final decision on the issue or escalated to senior management of the parties. If a dispute is escalated to senior management and no consensus is reached, then the dispute may be decided by the party to whom the contract grants final decision on such issue. Other issues can only be decided by consensus of the parties, and unless and until the parties representatives reach agreement on such issue, no decision on such issue will be made, and the status quo will be maintained.
Under the Astellas Collaboration Agreement, Astellas paid us a non-refundable, up-front cash payment of $110.0 million in the fourth quarter of 2009. We are also eligible to receive up to $335.0 million in development milestone payments, plus up to an additional $320.0 million in commercial milestone payments. As of December 31, 2011, we had received an aggregate of $13.0 million in development milestone payments under the Astellas Collaboration Agreement. Should the FDA or European Medicines Agency accept for filing an NDA or MAA, respectively, seeking approval of MDV3100 in post-chemotherapy patients based on the results of our AFFIRM trial, we would be entitled to a $10.0 million and a $5.0 million milestone payment, respectively, under the Astellas Collaboration Agreement, respectively. In addition, should the NDA be approved by the FDA or the MAA be approved by the European regulators, we would be entitled to a $30.0 million and a $15.0 million milestone payment under the Astellas Collaboration Agreement. We are required to share 10% of the up-front and development milestone payments received under the Astellas Collaboration Agreement with The Regents of the University of California, or UCLA, pursuant to the terms of our MDV3100 license agreement, which is discussed in the section below titled License Agreement with UCLA.
Each of Medivation and Astellas is permitted to terminate the Astellas Collaboration Agreement for an uncured material breach by the other party or for the insolvency of the other party. Astellas has a right to terminate the Astellas Collaboration Agreement unilaterally by advance written notice to us, but, except in certain specific circumstances, generally cannot exercise that termination right until the first anniversary of MDV3100s first commercial sale. Following any termination of the Astellas Collaboration Agreement in its entirety, all rights to develop and commercialize MDV3100 will revert to us, and Astellas will grant a license to us to enable us to continue such development and commercialization. In addition, except in the case of a termination by Astellas for our uncured material breach, Astellas will supply MDV3100 to us during a specified transition period.
License Agreement with UCLA
Under an August 2005 license agreement with UCLA, and subsequent amendments to this agreement, our subsidiary MPT holds an exclusive worldwide license under several UCLA patents and patent applications related to our MDV300 series compounds. Under our Astellas Collaboration Agreement, we granted Astellas a sublicense under the patent rights licensed to us by UCLA.
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We are required to pay UCLA an annual maintenance fee, up to $5.5 million in aggregate milestone payments upon the achievement of certain development and regulatory milestone events, and 10% of any up-front and development milestone payments we receive from sublicensees. We are also required to pay UCLA a single-digit royalty on sales of products falling within the scope of the patent rights licensed from UCLA. Should we receive marketing approval of MDV3100 either in the U.S. or Europe, we would be required to pay UCLA a single, one-time milestone payment of $2.0 million. UCLA may terminate the agreement if we do not meet a general obligation to diligently proceed with the development, manufacture, and sale of licensed products, or if we commit any other uncured material breach of the agreement. UCLA may also terminate the agreement if we fail to meet specific development, regulatory, and commercialization milestones by agreed-upon deadlines, which we may extend for a limited time period by paying an extension fee. We may terminate the agreement at any time upon advance written notice to UCLA. If neither party terminates the agreement early, the agreement will continue in force until the expiration of the last-to-expire licensed patent.
Termination of Pfizer Collaboration Agreement and Dimebon Program
In January 2012, we reported negative top line results from our Phase 3 CONCERT trial of our product candidate dimebon in patients with mild-to-moderate Alzheimers disease. We previously had reported negative top line results from our Phase 3 CONNECTION trial of dimebon in patients with mild-to-moderate Alzheimers disease and our Phase 3 HORIZON trial of dimebon in patients with Huntington disease. In January 2012, Pfizer exercised its right to terminate our collaboration agreement for the development and commercialization of dimebon and we and Pfizer discontinued development of dimebon for all indications. During the ensuing 180 days, we and Pfizer will work together to wind down our respective remaining collaboration activities.
Intellectual Property
We have an exclusive license to multiple issued patents and pending applications covering the MDV300 series compounds and uses thereof, including issued composition of matter patents covering MDV3100 in the U.S., Europe and Japan. The terms of these issued MDV3100 composition of matter patents expire in 2027 in the U.S. and in 2026 in Europe and Japan. We also own multiple pending patent applications covering our earlier stage technology programs. We intend to prosecute our owned intellectual property, and request that our licensors prosecute our licensed intellectual property, in the U.S., Europe, Japan and other jurisdictions that we deem appropriate.
Government Regulation and Product Approvals
FDA Approval Process
In the United States, pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug, and Cosmetic Act, or the FDC Act, and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products. Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending NDAs, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties, and criminal prosecution.
Pharmaceutical product development in the U.S. typically involves preclinical laboratory and animal tests, the submission to the FDA of either a notice of claimed investigational exemption or an investigational new drug application, or IND, which must become effective before clinical testing may commence, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug for each indication for which FDA approval is sought. Satisfaction of FDA pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity, and novelty of the product or disease.
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Preclinical tests include laboratory evaluation of product chemistry, formulation, and toxicity, as well as animal trials to assess the characteristics and potential safety and efficacy of the product. The conduct of the preclinical tests must comply with federal regulations and requirements, including good laboratory practices. The results of preclinical testing are submitted to the FDA as part of an IND along with other information, including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol. Long-term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may begin or continue after the IND is submitted.
A 30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA has neither commented on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin.
Clinical trials involve the administration of the IND to healthy volunteers or patients under the supervision of a qualified investigator. Clinical trials must be conducted: 1) in compliance with federal regulations; 2) in compliance with good clinical practice, or GCP, an international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators, and monitors; as well as 3) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the FDA as part of the IND.
The FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the clinical trial either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. The study protocol and informed consent information for patients in clinical trials must also be submitted to an institutional review board (IRB) or Ethics Committee (EC) for approval. An IRB/EC may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB/ECs requirements, or may impose other conditions.
Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap. In Phase 1, the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess metabolism, pharmacokinetics, pharmacological actions, side effects associated with increasing doses, and, if possible, early evidence on effectiveness. Phase 2 usually involves trials in a limited patient population to determine the effectiveness of the drug for a particular indication, dosage tolerance, and optimum dosage, and to identify common adverse effects and safety risks. If a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain the additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit FDA to evaluate the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug.
After completion of the required clinical testing, a NDA is prepared and submitted to the FDA. FDA approval of the NDA is required before marketing of the product may begin in the U.S. The NDA must include the results of all preclinical, clinical, and other testing and a compilation of data relating to the products pharmacology, chemistry, manufacture, and controls. The cost of preparing and submitting a NDA is substantial. Under federal law, the submission of most NDAs is additionally subject to a substantial application user fee, currently exceeding $1.8 million and the manufacturer and/or sponsor under an approved NDA are also subject to annual product and establishment user fees, currently approximately $0.1 million per product and $0.5 million per establishment. These fees are typically increased annually.
The FDA has 60 days from its receipt of a NDA to determine whether the application will be accepted for filing based on the FDAs threshold determination that it is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review. The FDA has agreed to certain performance goals in the review of NDAs. Most such applications for standard review drug products are reviewed within ten months; most applications for priority review drugs are reviewed in six months. We expect
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the FDA to amend each of these goals to extend them by two months for applications received after September 2012. Priority review can be applied to drugs that the FDA determines offer major advances in treatment, or provide a treatment where no adequate therapy exists. For biologics, priority review is further limited only for drugs intended to treat a serious or life-threatening disease relative to the currently approved products. The review process for both standard and priority review may be extended by FDA for three additional months to consider certain late-submitted information, or information intended to clarify information already provided in the submission. The FDA may also refer applications for novel drug products, or drug products which present difficult questions of safety or efficacy, to an advisory committeetypically a panel that includes clinicians and other expertsfor review, evaluation, and a recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving a NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve the product unless compliance with current good manufacturing practices, or cGMPa quality system regulating manufacturingis satisfactory and the NDA contains data that provide substantial evidence that the drug is safe and effective in the indication studied.
After FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing or information in order for the FDA to reconsider the application. If, or when, those deficiencies have been addressed to the FDAs satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included.
An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. As a condition of NDA approval, the FDA may require a risk evaluation and mitigation strategy, or REMS, to help ensure that the benefits of the drug outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals, and elements to assure safe use, or ETASU. ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability of the drug. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the drugs safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems are identified following initial marketing.
The Hatch-Waxman Act
In seeking approval for a drug through a NDA, applicants are required to list with the FDA each patent whose claims cover the applicants product. Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDAs Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Drugs listed in the Orange Book can, in turn, be cited by potential competitors in support of approval of an abbreviated new drug application, or ANDA. An ANDA provides for marketing of a drug product that has the same active ingredients in the same strengths and dosage form as the listed drug and has been shown through bioequivalence testing to be therapeutically equivalent to the listed drug. Other than the requirement for bioequivalence testing, ANDA applicants are not required to conduct, or submit results of, pre-clinical or clinical tests to prove the safety or effectiveness of their drug product. Drugs approved in this way are commonly referred to as generic equivalents to the listed drug, and can often be substituted by pharmacists under prescriptions written for the original listed drug.
The ANDA applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDAs Orange Book. Specifically, the applicant must certify that: 1) the required patent information has not been filed; 2) the listed patent has expired; 3) the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or 4) the listed patent is invalid or will not be
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infringed by the new product. A certification that the new product will not infringe the already approved products listed patents, or that such patents are invalid, is called a Paragraph IV certification. If the applicant does not challenge the listed patents, the ANDA application will not be approved until all the listed patents claiming the referenced product have expired.
If the ANDA applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once the ANDA has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days of the receipt of a Paragraph IV certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months, expiration of the patent, settlement of the lawsuit, or a decision in the infringement case that is favorable to the ANDA applicant.
The ANDA application also will not be approved until any non-patent exclusivity listed in the Orange Book for the referenced product has expired. Federal law provides a period of five years following approval of a drug containing no previously approved active ingredients during which ANDAs for generic versions of those drugs cannot be submitted, unless the submission contains a Paragraph IV challenge to a listed patentin which case the submission may be made four years following the original product approval. Federal law provides for a period of three years of exclusivity during which FDA cannot grant effective approval of an ANDA based on the approval of a listed drug that contains previously approved active ingredients but is approved in a new dosage form, route of administration or combination, or for a new use; the approval of which was required to be supported by new clinical trials conducted by, or for, the applicant.
Advertising and Promotion
Once a NDA is approved, a product will be subject to certain post-approval requirements. For instance, the FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the internet.
Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved labeling. Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new NDA or NDA supplement before the change can be implemented. A NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in reviewing NDAs.
Adverse Event Reporting and GMP Compliance
Adverse event reporting and submission of periodic reports is required following FDA approval of a NDA. The FDA also may require post-marketing testing, known as Phase 4 testing, risk minimization action plans, and surveillance to monitor the effects of an approved product, or the FDA may place conditions on an approval that could restrict the distribution or use of the product. In addition, quality-control, drug manufacture, packaging, and labeling procedures must continue to conform to GMP after approval. Drug manufacturers and certain of their subcontractors are required to register their establishments with FDA and certain state agencies. Registration with the FDA subjects entities to periodic unannounced inspections by the FDA, during which the agency inspects manufacturing facilities to assess compliance with current GMP. Accordingly, manufacturers must continue to expend time, money, and effort in the areas of production and quality-control to maintain compliance with current GMP. Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with regulatory standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered.
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Fast Track Designation
The FDA is required to facilitate the development, and expedite the review, of drugs that are intended for the treatment of a serious or life-threatening condition for which there is no effective treatment and which demonstrate the potential to address unmet medical needs for the condition. Under the fast track program, the sponsor of a new drug candidate may request that the FDA designate the drug candidate for a specific indication as a fast track drug concurrent with, or after, the filing of the IND for the drug candidate. The FDA must determine if the drug candidate qualifies for fast track designation within 60 days of receipt of the sponsors request.
In addition to other benefits, such as the ability to use surrogate endpoints and have greater interactions with FDA, the FDA may initiate review of sections of a fast track drugs NDA before the application is complete. This rolling review is available if the applicant provides, and FDA approves, a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, the FDAs time period goal for reviewing an application does not begin until the last section of the NDA is submitted. Additionally, the fast track designation may be withdrawn by the FDA if it believes that the designation is no longer supported by data emerging in the clinical trial process.
Accelerated Approval
Under the FDAs accelerated approval regulations, the FDA may approve a drug for a serious or life-threatening illness that provides meaningful therapeutic benefit to patients over existing treatments based upon a surrogate endpoint that is reasonably likely to predict clinical benefit. In clinical trials, a surrogate endpoint is a measurement of laboratory or clinical signs of a disease or condition that substitutes for a direct measurement of how a patient feels, functions, or survives. Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. A drug candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies, or confirm a clinical benefit during post-marketing studies, will allow the FDA to withdraw the drug from the market on an expedited basis. All promotional materials for drug candidates approved under accelerated regulations are subject to prior review by the FDA.
Anti-Kickback, False Claims Laws and the Prescription Drug Marketing Act
In addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal laws have been applied to restrict certain marketing practices in the pharmaceutical industry in recent years. These laws include anti-kickback statutes and false claims statutes. The federal healthcare program anti-kickback statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce; or in return for; purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service reimbursable under Medicare, Medicaid, or other federally financed healthcare programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other. Violations of the anti-kickback statute are punishable by imprisonment, criminal fines, civil monetary penalties, and exclusion from participation in federal healthcare programs. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution or other regulatory sanctions, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchases, or recommendations may be subject to scrutiny if they do not qualify for an exemption or safe harbor.
Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to have a false claim paid. Recently, several pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly inflating drug prices they report to pricing services, which in turn were used by the
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government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. In addition, certain marketing practices, including off-label promotion, may also violate false claims laws. The majority of states also have statutes or regulations similar to the federal anti-kickback law and false claims laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.
Physician Drug Samples
As part of the sales and marketing process, pharmaceutical companies frequently provide samples of approved drugs to physicians. The Prescription Drug Marketing Act, or the PDMA, imposes requirements and limitations upon the provision of drug samples to physicians, as well as prohibits states from licensing distributors of prescription drugs unless the state licensing program meets certain federal guidelines that include minimum standards for storage, handling, and record keeping. In addition, the PDMA sets forth civil and criminal penalties for violations.
Competition
The biopharmaceutical industry is intensely competitive in general. Furthermore, our business strategy is to target large unmet medical needs, and those markets are even more highly competitive. For example, since 2010 a new second-line chemotherapy drug, Jevtana (cabazitaxel), and a new oral hormonal drug, Zytiga (abiraterone acetate), have received marketing approval in the post-chemotherapy CRPC patient population we studied in our Phase 3 AFFIRM trial of MDV3100, and a new prostate cancer vaccine, Provenge (sipuleucel-T), received marketing approval covering both the post-chemotherapy CRPC population we studied in our Phase 3 AFFIRM trial and the chemotherapy-naïve CRPC population we are studying in our Phase 3 PREVAIL trial. Jevtana (cabazitaxel) and Zytiga (abiraterone acetate) have since acquired substantial shares in the market for treatment of post-chemotherapy patients, which may make it more difficult for us to compete successfully in this market, notwithstanding the positive results from our AFFIRM trial. In addition, enrollment has already been completed in a Phase 3 trial of Zytiga (abiraterone acetate) in the chemotherapy-naïve CRPC population we are studying in our Phase 3 PREVAIL trial. Several other drugs are also in advanced clinical development in both populations. Companies currently marketing, or expected to be marketing in the near future, products that will compete directly with any of our investigational drugs that may receive marketing approval include some of the worlds largest and most experienced pharmaceutical companies, such as Johnson & Johnson and sanofi-aventis. There are also multiple additional small molecule and recombinant protein candidates in development targeting advanced prostate cancer, including compounds already in Phase 3 clinical trials. Most, if not all, of these competing drug development programs are being conducted by pharmaceutical and biotechnology companies with considerably greater financial resources, human resources and experience than ours. Any of our product candidates that receive regulatory approval will face significant competition from both approved drugs and from any of the drugs currently under development that may subsequently be approved. Bases upon which our product candidates would have to compete successfully include efficacy, safety, price and cost-effectiveness. In addition, our product candidates would have to compete against these other drugs with several different categories of decision makers, including physicians, patients, government and private third-party payors, technology assessment groups and patient advocacy organizations. For example, Medicare Part B, which covers infused medicines, generally provides lower patient out-of-pocket expenses and better physician economics than does Medicare Part D, which covers oral medicines. One of our primary competitors in post-docetaxel patients, the infused chemotherapy drug Jevtana (cabazitaxel), is reimbursed under Medicare Part B while MDV3100, should it receive marketing approval and be reimbursed by Medicare, would be covered under Medicare Part D. Even if one of our product candidates is approved, we cannot guarantee that we, Astellas or any of our potential future partners will be able to compete successfully on any of these bases. Any future product candidates that we may subsequently acquire will face similar competitive pressures. If we or our current or potential future partners cannot compete successfully on any of the bases described above, our business will not succeed.
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Research and Development Expense
A significant portion of our operating expense is related to research and development, and we intend to maintain our strong commitment to research and development. For the years ended December 31, 2011, 2010 and 2009, we recorded $73.4 million, $72.2 million and $87.7 million, respectively, of research and development expenses. Research and development expenses represented 71%, 76% and 75% of total operating expenses in the years ended December 31, 2011, 2010 and 2009, respectively. More information regarding our research and development activities can be found in the section entitled Managements Discussion and Analysis of Financial Condition and Results of Operations under Item 7 of this Annual Report.
Manufacturing
Our business strategy is to use current GMP compliant contract manufacturers for manufacture of clinical supplies as well as for commercial supplies if required by our commercialization plans, and to transfer manufacturing responsibility to our collaboration partners when possible.
The MDV3100 being used in our completed and ongoing trials was manufactured by cGMP-compliant contract manufacturers. Pursuant to the Astellas Collaboration Agreement, Astellas has agreed to assume commercial manufacturing responsibility for MDV3100, after we complete transfer of those responsibilities to Astellas. Commercial manufacturing processes for MDV3100 have not yet been validated. Based on currently available information, we believe that MDV3100 drug product can be manufactured at commercial scale on a cost-effective basis. However, we caution you that this is a forward-looking statement and that we cannot guarantee that we will be able to complete this work on a timely basis or at all.
Employees
As of December 31, 2011, we had 121 full-time employees, none of which are represented by labor unions or covered by collective bargaining agreements. We consider our relationships with our employees to be good.
Available Information
Our website address is www.medivation.com; however, information found on, or that can be accessed through, our website is not incorporated by reference into this Annual Report on Form 10-K. We file or furnish electronically with the SEC our Annual Report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act. We make available free of charge on or through our website copies of these reports as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.
The SEC maintains an internet site that contains reports, proxy and information statements and other information regarding our filings at www.sec.gov. You may also read and copy any of our materials filed with the SEC at the SECs Public Reference Room at 100 F Street, NE, Washington, DC 20549. Information regarding the operation of the Public Reference Room can be obtained by calling the SEC at 1-800-SEC-0330.
Item 1A. | Risk Factors. |
Our business faces significant risks, some of which are set forth below to enable readers to assess, and be appropriately apprised of, many of the risks and uncertainties applicable to the forward-looking statements made in this Annual Report. You should carefully consider these risk factors as each of these risks could adversely affect our business, operating results, cash flows and financial condition. If any of the events or circumstances described in the following risks actually occurs, our business may suffer, the trading price of our common stock could decline and our financial condition or results of operations could be harmed. Given these risks and
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uncertainties, you are cautioned not to place undue reliance on forward-looking statements. These risks should be read in conjunction with the other information set forth in this Annual Report. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us, or that we currently believe to be immaterial, may also adversely affect our business.
Risks Related to Our Business
We have incurred net losses since inception, expect to incur additional losses in the future as we continue our development activities and may never achieve sustained revenues or profitability. Our only revenue to date has been collaboration revenue under our collaboration agreement with Astellas Pharma Inc., or Astellas, and our former collaboration agreement with Pfizer Inc., or Pfizer. MDV3100 has not received marketing approval, and we do not know when or if it will receive marketing approval or become commercially available. We have incurred losses since inception and expect to continue to incur substantial additional losses for the foreseeable future as we continue to finance clinical and preclinical studies of MDV3100 and potential future product candidates, potential launch costs of MDV3100 should that agent receive marketing approval, and our corporate overhead costs. Our operating losses have had, and will continue to have, an adverse impact on our working capital, total assets and stockholders equity. We do not know when or if we will ever generate any additional revenue, including any milestone payments, profit sharing payments or royalty payments under our collaboration agreement with Astellas, or become cash-flow positive, because of the significant uncertainties with respect to our ability to generate product revenue from, and obtain approval from the FDA, or comparable foreign regulatory authorities for, MDV3100 or future product candidates.
Because we depend on financing from third parties for our operations, our business may fail if such financing becomes unavailable or is offered on commercially unreasonable terms. To date, we have financed our operations primarily through private and public offerings of our common stock and from up-front, development milestone and cost-sharing payments received pursuant to our collaboration agreement with Astellas and our former collaboration agreement with Pfizer. As of December 31, 2011 we had cash, cash equivalents and short-term investments totaling $145.1 million available to fund our operations. Based upon our current expectations, we believe our capital resources at December 31, 2011 will be sufficient to fund our currently planned operations for the next 12 months. This estimate is based on a number of assumptions that may prove to be wrong, and we could exhaust our available cash, cash equivalents and short-term investments earlier than presently anticipated. We may be required or choose to seek additional capital within the next 12 months to expand our clinical development activities for MDV3100 based on the positive results of our Phase 3 AFFIRM trial in post-chemotherapy advanced prostate cancer patients, to fund costs of planning for and executing a commercial launch of MDV3100, should it receive marketing approval, if we face challenges or delays in connection with our clinical trials or the potential approval and commercialization of MDV3100, or to maintain minimum cash balances that we deem reasonable and prudent. In addition, we intend to evaluate the capital markets from time to time to determine whether to raise additional capital in the form of equity, convertible debt or otherwise, depending on market conditions relative to our need for funds at such time, and we may seek to raise additional capital within the next 12 months should we conclude that such capital is available on terms that we consider to be in the best interests of our company and our stockholders.
We have incurred losses since inception and expect to continue to incur substantial additional losses for the foreseeable future as we pursue regulatory approval for, and, if approved, commercial launch of, MDV3100 and continue to finance clinical and preclinical studies of MDV3100 and potential future product candidates and our corporate overhead costs. Our future capital requirements will depend on many factors, including without limitation:
| potential launch costs of MDV3100, should that agent receive marketing approval for post-chemotherapy patients; |
| the timing and magnitude of any potential sales of MDV3100, should that agent receive marketing approval for post-chemotherapy patients; |
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| whether any changes are made to the scope of our ongoing clinical development activities; |
| the scope and results of our and our collaboration partners preclinical and clinical trials; |
| whether we experience delays in our preclinical and clinical development programs, including potential delays in recruiting, or inability to recruit, patients into our ongoing PREVAIL trial of MDV3100 in pre-chemotherapy advanced prostate cancer as a result of the availability of Zytiga (abiraterone acetate), which was approved by the FDA in April 2011 for post-chemotherapy patients, or other investigational and approved prostate cancer therapies, including MDV3100 itself should that agent be approved to treat post-chemotherapy patients, or slower than anticipated product development; |
| whether opportunities to acquire additional product candidates arise and the timing and costs of acquiring and developing those product candidates; |
| whether we are able to enter into additional third-party collaborative partnerships to develop and/or commercialize potential future product candidates on terms, including development cost share terms, that are acceptable to us; |
| the timing and requirements of, and the costs involved in, conducting studies required to obtain regulatory approvals for MDV3100 or potential future product candidates from the FDA and comparable foreign regulatory agencies; |
| the availability of third parties to perform the key development tasks for MDV3100 and potential future product candidates, including conducting preclinical and clinical studies and manufacturing our product candidates to be tested in those studies, and the associated costs of those services; |
| expenses associated with the pending purported securities class action lawsuits, as well as any other litigation; and |
| the costs involved in preparing, filing, prosecuting, maintaining, defending the validity of and enforcing patent claims and other costs related to patent rights and other intellectual property rights, including litigation costs and the results of such litigation. |
Our current view of the worldwide capital markets is that they are extremely volatile with limited accessibility, and many biotechnology companies have had limited or no success in obtaining funding in this environment. Continuation of this challenging market climate may significantly limit our ability to raise funds, and there can be no assurance we will be able to raise additional funds on acceptable terms or at all. If we are unable to raise additional funds when needed, we could be required to delay, scale back or eliminate some or all of our development programs and other operations. We may seek to raise additional funds through public or private financing or other arrangements. Any additional equity financing would be dilutive to stockholders, and debt financing, if available, may involve restrictive covenants. Our failure to raise capital when needed may harm our business and operating results.
Even if we receive regulatory approval of MDV3100 or any potential future product candidates, which we may never do, we must successfully commercialize such products before we can become profitable. It is not unusual for new pharmaceutical products to be commercially unsuccessful or achieve a lower than expected level of commercial success. We expect to incur substantial expenses associated with our commercialization efforts even prior to obtaining regulatory approval of such product candidates, including MDV3100, as well as thereafter. We may never generate significant revenues and, even if we do generate revenues, the magnitude of those revenues may never be sufficient for us to achieve or sustain profitability.
As we evolve from a company primarily involved in research and development to a company also potentially involved in commercialization, we may encounter difficulties in managing our growth and expanding our operations successfully. Although certain of our employees have commercialization experience, as a company we currently have only limited commercial capabilities. To be prepared to perform our co-promotion activities for MDV3100, should it be approved in the U.S., we will need to expand our organization substantially, including
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marketing and sales capabilities or contract with third parties to provide these capabilities for us, which will be expensive and time consuming. Any failure or delay in the development of our internal commercial capabilities would adversely impact the commercialization of MDV3100 in the event it receives regulatory approval. If we are not successful in commercializing MDV3100 or potential future product candidates in the event they receive regulatory approval, our future product revenue will suffer and we may incur significant additional losses.
As our operations expand, we expect that we will need to manage additional relationships with various collaborative partners, suppliers and other third parties. Future growth will impose significant added responsibilities on members of management. Our future financial performance and our ability to commercialize MDV3100 and to compete effectively will depend, in part, on our ability to manage any future growth effectively. To that end, we must be able to manage our development efforts effectively, and hire, train and integrate additional management, administrative and sales and marketing personnel. We may not be able to accomplish these tasks, and our failure to accomplish any of them could prevent us from successfully growing our company.
Our business strategy depends on our ability to identify and acquire additional product candidates which we may never acquire or identify for reasons that may not be in our control, or are otherwise unforeseen or unforeseeable to us. A key component of our business strategy is to diversify our product development risk by identifying and acquiring new product opportunities for development. However, we may not be able to identify promising new technologies. In addition, the competition to acquire promising biomedical technologies is fierce, and many of our competitors are large, multinational pharmaceutical, biotechnology and medical device companies with considerably more financial, development and commercialization resources and experience than we have. Thus, even if we succeed in identifying promising technologies, we may not be able to acquire rights to them on acceptable terms or at all. If we are unable to identify and acquire new technologies, we will be unable to diversify our product risk. We believe that any such failure would have a significant negative impact on our prospects because the risk of failure of any particular development program in the pharmaceutical industry is high.
Because we depend on our management to oversee the execution of development plans for MDV3100 and to identify and acquire promising new product candidates, the loss of any of our executive officers would harm our business. Our future success depends upon the continued services of our executive officers. We are particularly dependent on the continued services of David Hung, M.D., our president and chief executive officer and a member of our board of directors. Dr. Hung identified MDV3100 for acquisition and has primary responsibility for identifying and evaluating other potential product candidates. We believe that Dr. Hungs services in this capacity would be difficult to replace. None of our executive officers is bound by an employment agreement for any specific term, and they may terminate their employment at any time. In addition, we do not have key person life insurance policies covering any of our executive officers. The loss of the services of any of our executive officers could delay the development of MDV3100 and delay or preclude the identification and acquisition of new product candidates, either of which events could harm our business.
Our reliance on third parties for the operation of our business may result in material delays, cost overruns and/or quality deficiencies in our development programs. We rely on outside vendors to perform key product development tasks, such as conducting preclinical and clinical studies and manufacturing our product candidates at appropriate scale for preclinical and clinical trials and, in situations where we are unable to transfer those responsibilities to a corporate partner, for commercial use as well. In order to manage our business successfully, we will need to identify, engage and properly manage qualified external vendors that will perform these development activities. For example, we need to monitor the activities of our vendors closely to ensure that they are performing their tasks correctly, on time, on budget and in compliance with strictly enforced regulatory standards. Our ability to identify and retain key vendors with the requisite knowledge is critical to our business and the failure to do so could negatively impact our business. Because all of our key vendors perform services for other clients in addition to us, we also need to ensure that they are appropriately prioritizing our projects. If we fail to manage our key vendors well, we could incur material delays, cost overruns or quality deficiencies in our development programs, as well as other material disruptions to our business.
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Risks Related to Our Product Development Candidates
Pharmaceutical product candidates require extensive, time-consuming and expensive preclinical and clinical testing to establish safety and efficacy. We may never attract additional partners for our technologies or receive marketing approval in any jurisdiction. The research and development of pharmaceuticals is an extremely risky industry. Only a small percentage of product candidates that enter the development process ever receive marketing approval. MDV3100 is not currently approved for sale anywhere in the world, and it may never receive such approval. The process of conducting the preclinical and clinical testing required to establish safety and efficacy and obtain marketing approval is expensive and uncertain and takes many years. If we are unable to complete preclinical or clinical trials of MDV3100 or future product candidates, or if the results of these trials are not satisfactory to convince regulatory authorities or partners of their safety or efficacy, we will not be able to obtain marketing approval or attract additional partners for those product candidates. Furthermore, even if we or our partners are able to obtain marketing approvals for any of our product candidates, those approvals may be for indications that are not as broad as desired or may contain other limitations that would adversely affect our ability to generate revenue from sales of those products. If this occurs, our business will be materially harmed and our ability to generate revenue will be severely impaired.
Because our ongoing Phase 3 PREVAIL trial of MDV3100 in pre-chemotherapy patients has overall survival as a primary endpoint, the availability of approved and/or experimental agents that prolong survival, including the approved hormonal agent Zytiga (abiraterone acetate), the approved chemotherapy agents docetaxel and Jevtana (cabazitaxel), and the approved prostate cancer vaccine Provenge (sipuleucel-T), as well as the potential commercial availability of MDV3100 itself should it be approved for post-chemotherapy patients, may make it more difficult for our PREVAIL trial to succeed or may prevent it from succeeding, and could reduce the magnitude of any potential survival benefit that MDV3100 may demonstrate in PREVAIL even if that trial does succeed. Our ongoing Phase 3 PREVAIL trial in pre-chemotherapy advanced prostate cancer is attempting to demonstrate a statistically significant difference in survival between drug-treated and placebo-treated patients. Overall survival and progression-free survival are the co-primary endpoints in our ongoing PREVAIL trial. Patients participating in our PREVAIL trial may elect to leave the trial and switch to alternative treatments that are, or may in the future become, available to them commercially, such as Zytiga (abiraterone acetate), docetaxel, Jevtana (cabazitaxel), and Provenge (sipuleucel-T), or MDV3100 itself should it be approved for post-chemotherapy patients based on the positive results in the AFFIRM trial. Each of these alternative treatments has demonstrated statistically significant survival benefits of between two and one-half and five months in advanced prostate cancer patients and, except for MDV3100, is commercially available. Patients from our PREVAIL trial may be able to obtain commercial access to these alternative agents notwithstanding the fact that, other than Provenge (sipuleucel-T), none of them has been shown to prolong survival in pre-chemotherapy patients. However, Zytiga (abiraterone acetate) is being studied in an ongoing Phase 3 clinical trial evaluating its potential ability to prolong survival in pre-chemotherapy patients, and positive results from that trial could become available at any time. The survival of any patients who leave our PREVAIL trial to take an alternative treatment will continue to be included in the analysis of the trial. Any survival benefit conferred by these alternative treatments may have a negative impact on the results of our PREVAIL trial, particularly in the case of the one-half of all patients in our PREVAIL trial who were randomized to placebo. Patients in our PREVAIL trial are free to leave the trial at any time, and are free to take any alternative treatment once they have left the trial. We have no ability to control or influence either of these decisions. Use of other alternative life-prolonging treatments by patients leaving our PREVAIL trial could make it more difficult for the trial to succeed, could prevent it from succeeding, and could reduce any potential survival benefit that may be demonstrated even if does succeed. Failure of our PREVAIL trial could have significant negative effects on us, including preventing us from obtaining marketing approval in pre-chemotherapy advanced prostate cancer, which is a far larger commercial opportunity than post-chemotherapy advanced prostate cancer, being required to conduct additional trials, or causing our partner Astellas to elect to terminate our collaboration agreement. Even if our PREVAIL trial succeeds, any negative impact on the survival benefit shown in that trial could reduce or eliminate MDV3100s ability to compete effectively with other treatments that have shown longer survival benefits.
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Enrollment and retention of patients in clinical trials is an expensive and time-consuming process, could be made more difficult or rendered impossible by multiple factors outside our control, including the availability of competing treatments or clinical trials of competing drugs for the same indication and the results of other studies of our product candidates in the same or other indications, and could result in significant delays, cost overruns, or both, in our product development activities, or in the failure of such activities. We may encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of our clinical trials, and even once enrolled we may be unable to retain a sufficient number of patients to complete any of our trials. Patient enrollment and retention in clinical trials depends on many factors, including the size of the patient population, the nature of the trial protocol, the existing body of safety and efficacy data with respect to the study drug, the number and nature of competing treatments and ongoing clinical trials of competing drugs for the same indication, the proximity of patients to clinical sites and the eligibility criteria for the study. For example, there are multiple ongoing Phase 3 trials competing with our ongoing PREVAIL trial to recruit pre-chemotherapy advanced prostate cancer patients, including an ongoing Phase 3 trial of an investigational agent from Takeda Pharmaceuticals that operates by the same molecular mechanism of action as the approved drug Zytiga (abiraterone acetate). Furthermore, because patients in our PREVAIL trial have a 50% chance of being randomized to placebo, the availability of competing treatments may make it more difficult, or impossible, to complete enrollment in the PREVAIL trial. Such competing treatments include the approved hormonal agent Zytiga (abiraterone acetate), the approved chemotherapy agents Jevtana (cabazitaxel) and docetaxel, and the approved prostate cancer vaccine Provenge (sipuleucel-T), all of which have been shown to prolong overall survival in advanced prostate cancer patients. To date, Zytiga (abiraterone acetate) has been shown to prolong overall survival only in post-chemotherapy advanced prostate cancer patients. However, Zytiga (abiraterone acetate) is being studied in an ongoing Phase 3 trial evaluating that drugs potential ability to prolong overall survival in pre-chemotherapy advanced prostate cancer patients, the same population being studied in our PREVAIL trial. Should data from the ongoing Zytiga (abiraterone acetate) Phase 3 trial become available that demonstrate an overall survival benefit in pre-chemotherapy patients, such data could make it more difficult or impossible for us to recruit and retain patients in our PREVAIL trial, as those patients may prefer to take Zytiga (abiraterone acetate) rather than participate in our PREVAIL trial. In addition, should MDV3100 receive marketing approval in post-chemotherapy patients based on the positive results in the AFFIRM trial, patients in our PREVAIL trial may elect to leave the study and attempt to receive MDV3100 commercially, despite the fact that MDV3100 has not been shown to prolong overall survival in pre-chemotherapy patients. Such development could make it more difficult or impossible for us to retain patients in our PREVAIL trial. Furthermore, any negative results we may report in clinical trials of MDV3100 or any potential future product candidates may make it difficult or impossible to recruit and retain patients in other clinical studies of that same product candidate. Delays or failures in planned patient enrollment and/or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability to develop MDV3100 or any other product candidates, or could render further development impossible.
Positive results from our AFFIRM trial in post-chemotherapy advanced prostate cancer may not be predictive of results of our PREVAIL trial in pre-chemotherapy advanced prostate cancer or any of our other ongoing and potential future clinical trials of MDV3100. Product candidates in clinical trials, including Phase 3 clinical trials, often fail to show the desired safety and efficacy outcomes despite having progressed successfully through prior stages of preclinical and clinical testing. Even where we achieve positive results in clinical trials, subsequent clinical trials may fail, even if those subsequent trials are designed very similarly to their predecessors. Accordingly, despite the positive results from our Phase 3 AFFIRM trial of MDV3100 in post-chemotherapy advanced prostate cancer, our ongoing Phase 3 PREVAIL trial in pre-chemotherapy advanced prostate cancer, our ongoing Phase 2 TERRAIN trial comparing MDV3100 to bicalutamide, our ongoing Phase 2 study of MDV3100 in hormone-naïve patients, and any other of our ongoing or planned studies of MDV3100 may fail.
MDV3100 and any of our other potential future product candidates, should any of them, receive marketing approval, will face significant competition from other approved products and other products in development. The biopharmaceutical industry is intensely competitive in general. Furthermore, our business strategy is to target large unmet medical needs, and those markets are even more highly competitive. For example, since 2010 a new
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second-line chemotherapy drug, Jevtana (cabazitaxel), and a new oral hormonal drug, Zytiga (abiraterone acetate), have received marketing approval in the post-chemotherapy CRPC patient population we studied in our Phase 3 AFFIRM trial of MDV3100, and a new prostate cancer vaccine, Provenge (sipuleucel-T), received marketing approval covering both the post-chemotherapy CRPC population we studied in our Phase 3 AFFIRM trial and the chemotherapy-naïve CRPC population we are studying in our Phase 3 PREVAIL trial. Jevtana (cabazitaxel) and Zytiga (abiraterone acetate) have since acquired substantial shares of the market for treatment of post-chemotherapy patients, which may make it more difficult for us to compete successfully in this market, notwithstanding the positive results from our AFFIRM trial. In addition, enrollment has already been completed in a Phase 3 trial of Zytiga (abiraterone acetate) in the chemotherapy-naïve CRPC population we are studying in our Phase 3 PREVAIL trial. Several other drugs are also in advanced clinical development in both populations. Companies currently marketing, or expected to be marketing in the near future, products that will compete directly with any of our investigational drugs that may receive marketing approval include some of the worlds largest and most experienced pharmaceutical companies, such as Johnson & Johnson and sanofi-aventis. There are also multiple additional small molecule and recombinant protein candidates in development targeting advanced prostate cancer, including compounds already in Phase 3 clinical trials. Most, if not all, of these competing drug development programs are being conducted by pharmaceutical and biotechnology companies with considerably greater financial resources, human resources and experience than ours. Any of our product candidates that receive regulatory approval will face significant competition from both approved drugs and from any of the drugs currently under development that may subsequently be approved. Bases upon which our product candidates would have to compete successfully include efficacy, safety, price and cost-effectiveness. In addition, our product candidates would have to compete against these other drugs with several different categories of decision makers, including physicians, patients, government and private third-party payors, technology assessment groups and patient advocacy organizations. For example, Medicare Part B, which covers infused medicines, generally provides lower patient out-of-pocket expenses and better physician economics than does Medicare Part D, which covers oral medicines. One of our primary competitors in post-docetaxel patients, the infused chemotherapy drug Jevtana (cabazitaxel), is reimbursed under Medicare Part B while MDV3100, should it receive marketing approval and be reimbursed by Medicare, would be covered under Medicare Part D. Even if one of our product candidates is approved, we cannot guarantee that we, Astellas or any of our potential future partners will be able to compete successfully on any of these bases. Any future product candidates that we may subsequently acquire will face similar competitive pressures. If we or our partners cannot compete successfully on any of the bases described above, our business will not succeed.
MDV3100 and any other potential future product candidate that is eventually approved for sale may not be commercially successful if not widely-covered and appropriately reimbursed by third-party payors at levels that produce patient co-payments that are acceptable and affordable to patients. Third-party payors, including public insurers such as Medicare and Medicaid and private insurers, pay for a large share of health care products and services consumed in the United States. In Europe, Canada and other major international markets, third-party payors also pay for a significant portion of health care products and services and many of those countries have nationalized health care systems in which the government pays for all such products and services and must approve product pricing. Even if approved by the FDA and foreign regulatory agencies, MDV3100 and any potential future product candidates are unlikely to achieve commercial success unless they are covered widely by third-party payors and reimbursed at a rate that generates an acceptable commercial return for us and any collaborative partner. In addition, even if they ultimately elect to reimburse our product candidates, most third-party payors will not reimburse 100% of the cost, but rather require a portion of the cost to be borne by the patients themselves. Thus, even if reimbursement is available, the percentage of drug cost required to be borne by the patients may make use of our product candidates financially difficult or impossible for certain patients, which would have a negative impact on sales of our product candidates. It is increasingly difficult to obtain coverage and acceptable reimbursement levels from third-party payors, and we may be unable to achieve these objectives. Achieving coverage and acceptable reimbursement levels typically involves negotiating with individual payors and is a time-consuming and costly process. Moreover, comprehensive health care reform legislation was recently enacted in the United States that substantially changes the way health care is financed by both governmental and private insurers, and significantly impacts the pharmaceutical industry. The new legislation
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contains a number of provisions that are expected to impact our business and operations, including those relating to the increased use of comparative effectiveness research on health care products, changes to enrollment in federal healthcare programs, reimbursement changes and fraud and abuse provisions, all of which will impact existing government health care programs and will result in the development of new programs. Many of the details regarding the implementation of this legislation have yet to be determined and implementation may ultimately adversely affect our business. Further, we expect that there will continue to be a number of federal and state proposals to implement government controls over drug product pricing. We are currently unable to predict what additional legislation or regulations, if any, relating to the pharmaceutical industry or third-party payor coverage and reimbursement may be enacted in the future, or what effect the recently enacted federal health care reform legislation or any such additional legislation or regulation will or would have on our business. In addition, we would face competition in such negotiations from other approved drugs against which we compete, which may include other approved drugs marketed by Astellas, and the marketers of such other drugs are likely to be significantly larger than us and therefore enjoy significantly more negotiating leverage with respect to the individual payors than we may have. Our commercial prospects would be further weakened if payors approved coverage for MDV3100 or any potential future product candidates only as second- or later-line treatments, or if they placed any of those product candidates in tiers requiring unacceptably high patient co-payments. Failure to achieve acceptable coverage and reimbursement levels could materially harm our or our partners ability to successfully market our product candidates.
We are dependent upon our collaborative relationship with Astellas to further develop, manufacture and commercialize MDV3100. There may be circumstances that delay or prevent Astellas ability to develop, manufacture and commercialize MDV3100 or that result in Astellas terminating our agreement with them. In October 2009, we announced that we had entered into a collaboration agreement with Astellas for the development, manufacture and commercialization of MDV3100 to treat prostate cancer. Under the agreement, Astellas is responsible for developing, seeking regulatory approval for, and commercializing MDV3100 outside the United States and, following a transition period, is responsible globally for all manufacture of product for both clinical and commercial purposes. We and Astellas are jointly responsible for developing, seeking regulatory approval for, and commercializing MDV3100 in the United States. We and Astellas share equally the costs, profits and losses arising from development and commercialization of MDV3100 in the United States. For clinical trials useful both in the United States and in Europe or Japan, we will be responsible for one-third of the total costs and Astellas will be responsible for the remaining two-thirds.
We are subject to a number of risks associated with our dependence on our collaborative relationship with Astellas, including:
| Astellas right to terminate the collaboration agreement with us on limited notice for convenience (subject to certain limitations), or for other reasons specified in the respective collaboration agreement; |
| the need for us to identify and secure on commercially reasonable terms the services of third parties to perform key activities currently performed by Astellas in the event that Astellas were to terminate its collaboration with us, including clinical and, if approved, commercial manufacturing, development activities outside of the United States and commercialization activities globally; |
| adverse decisions by Astellas regarding the amount and timing of resource expenditures for the development and commercialization of MDV3100; |
| decisions by Astellas to prioritize other of its present or future products more highly than MDV3100 for either development and/or commercial purposes; |
| possible disagreements as to the timing, nature and extent of our development plans, including clinical trials or regulatory approval strategy; |
| changes in key management personnel that are members of the collaborations various committees; and |
| possible disagreements with Astellas, including those regarding the development and/or commercialization of products, interpretation of the collaboration agreement and ownership of proprietary rights. |
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Due to these factors and other possible disagreements with Astellas, we may be delayed or prevented from further developing, manufacturing or potentially commercializing MDV3100 or we may become involved in litigation or arbitration, which would be time consuming and expensive.
If Astellas were to unilaterally terminate our collaborative relationship, we would need to undertake development, manufacturing and marketing activities for MDV3100 solely at our own expense and/or seek one or more other partners for some or all of these activities, worldwide. If we pursued these activities on our own, it would significantly increase our capital and infrastructure requirements, might limit the indications we are able to pursue for MDV3100, and could prevent us from effectively developing and potentially commercializing MDV3100. If we sought to find one or more other pharmaceutical company partners for some or all of these activities, we may not be successful in such efforts, or they may result in collaborations that have us expending greater funds and efforts than our current relationship with Astellas.
We are dependent on the efforts of, and funding by, Astellas for the development of MDV3100. Under the terms of the Astellas Collaboration Agreement, we and Astellas must agree on any changes to the development plan for MDV3100 that is set forth in the agreement. If we and Astellas cannot agree on any such changes, clinical trial progress could be significantly delayed or halted. Subject to certain limitations set forth in the Astellas Collaboration Agreement, Astellas is generally free to terminate the agreement at its discretion on limited notice to us. Similarly, in the event of an uncured material breach of the agreement by us, Astellas may elect to terminate the agreement, in which case all rights to develop and commercialize MDV3100 will revert to us. If Astellas terminates its co-funding of our MDV3100 program, we may be unable to fund the development and potential commercialization costs on our own and may be unable to find another partner, which could force us to raise additional capital or could cause our MDV3100 program to fail. In addition, Astellas is solely responsible for the development and regulatory approval of MDV3100 outside the United States, so we are entirely dependent on Astellas for the successful completion of those activities.
The financial returns to us, if any, under our collaboration agreement with Astellas depend in large part on the achievement of development and commercialization milestones, plus a share of any profits from any product sales in the United States and royalties on any product sales outside of the United States. Therefore, our success, and any associated financial returns to us and our investors, will depend in large part on the performance of Astellas under the Astellas Collaboration Agreement. If Astellas fails to perform or satisfy its obligations to us, the development, potential regulatory approval or commercialization of MDV3100 would be delayed or may not occur and our business and prospects could be materially and adversely affected for that reason.
We are dependent on the efforts of Astellas to market and promote MDV3100 if approved for commercial sale. Under our collaboration with Astellas, we and Astellas have the right to co-promote MDV3100 to all customers in the United States, and Astellas has the sole right to promote MDV3100 to all customers outside of the United States. We are thus partially dependent on Astellas to successfully promote MDV3100 in the United States and solely dependent on Astellas to successfully promote MDV3100 outside of the United States. We have limited ability to direct Astellas in its potential commercialization of MDV3100 in any country, including the United States. If Astellas fails to adequately market and promote MDV3100, whether inside or outside of the United States, we may be unable to obtain any remedy against Astellas. If this were to happen, any sales of MDV3100 may be harmed, which would negatively impact our business, results of operations, cash flows and liquidity.
We are dependent on Astellas to manufacture clinical and commercial requirements of MDV3100, which could result in the delay of clinical trials or regulatory approval or lost sales. Under our agreement with Astellas, after a transition period, Astellas has the primary right and responsibility to manufacture and/or manage the supply of MDV3100 for clinical trials and all commercial requirements. We are in the process of transitioning the manufacturing obligations for MDV3100 to Astellas. Consequently, we are, and expect to remain, dependent on Astellas to supply MDV3100. Astellas may encounter difficulties in production scale-up, including problems involving production yields, quality control and quality assurance, and shortage of qualified personnel. Astellas may not perform as agreed or may default in their obligations to supply clinical trial supplies
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and/or commercial product. Astellas may fail to deliver the required quantities of MDV3100 on a timely basis. Any such failure by Astellas could delay our future clinical trials and our applications for regulatory approval, or, if approved for commercial sale, could impair our ability to meet the market demand for MDV3100 and therefore result in decreased sales. If Astellas does not adequately perform, we may be forced to incur additional expenses, delays, or both, to arrange or take responsibility for other third parties to manufacture MDV3100 on our behalf, as we do not have any internal manufacturing capabilities.
If Astellas business strategies change, any such changes may adversely affect our collaborative relationship with Astellas. Astellas may change its business strategy. Decisions by Astellas to either reduce or eliminate its participation in the prostate cancer field, to emphasize other competitive agents currently in its portfolio at the expense of MDV3100, or to add additional competitive agents to its portfolio, could reduce its financial incentives to continue to develop, seek regulatory approval for, or potentially commercialize MDV3100. For example, Astellas has partnered with us based in part on Astellas desire to use MDV3100 as a component of building a global oncology franchise, which Astellas presently does not have. If Astellas strategic objective of building a global oncology franchise were to change, such change could negatively impact any commercial prospects of MDV3100.
Our industry is highly regulated by the FDA and comparable foreign regulatory agencies. We must comply with extensive, strictly enforced regulatory requirements in order to develop and obtain marketing approval for any of our product candidates. Before we, Astellas or any potential future partners can obtain regulatory approval for the sale of our product candidates, our product candidates must be subjected to extensive preclinical and clinical testing to demonstrate their safety and efficacy for humans.
The preclinical and clinical trials of any product candidates that we develop must comply with regulation by numerous federal, state and local government authorities in the United States, principally the FDA, and by similar agencies in other countries. We are required to obtain and maintain an effective IND application to commence human clinical trials in the United States and must obtain and maintain additional regulatory approvals before proceeding to successive phases of our clinical trials. Securing FDA approval requires the submission of extensive preclinical and clinical data and supporting information for each therapeutic indication to establish the product candidates safety and efficacy for its intended use. It takes years to complete the testing of a new drug or medical device and development delays and/or failure can occur at any stage of testing. Any of our present and future clinical trials may be delayed or halted due to any of the following:
| any preclinical test or clinical trial may fail to produce safety and efficacy results satisfactory to the FDA or foreign regulatory authorities; |
| preclinical and clinical data can be interpreted in different ways, which could delay, limit or prevent regulatory approval; |
| as we experienced with dimebon, negative or inconclusive results from a preclinical test or clinical trial or adverse medical events during a clinical trial could cause a preclinical study or clinical trial to be repeated or a program to be terminated, even if other studies or trials relating to the program are ongoing or have been completed and were successful; |
| the FDA or foreign regulatory authorities can place a clinical hold on a trial if, among other reasons, it finds that patients enrolled in the trial are or would be exposed to an unreasonable and significant risk of illness or injury; |
| the FDA might not approve the clinical processes or facilities that we utilize, or the processes or facilities of our consultants, including without limitation the vendors who will be manufacturing drug substance and drug product for us or any potential collaborators; |
| any regulatory approval we, Astellas or any potential future collaborators ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the product not commercially viable; and |
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| we may encounter delays or rejections based on changes in FDA policies or the policies of foreign regulatory authorities during the period in which we develop a product candidate or the period required for review of any final regulatory approval before we are able to market any product candidate. |
In addition, information generated during the clinical trial process is susceptible to varying interpretations that could delay, limit, or prevent regulatory approval at any stage of the approval process. Failure to demonstrate adequately the quality, safety and efficacy of any of our product candidates would delay or prevent regulatory approval of the applicable product candidate. There can be no assurance that if clinical trials are completed, either we or our collaborative partners will submit applications for required authorizations to manufacture or market potential products or that any such application will be reviewed and approved by appropriate regulatory authorities in a timely manner, if at all.
If MDV3100 or any potential future product candidates cannot be manufactured in a cost-effective manner and in compliance with current GMP and other applicable regulatory standards, they will not be commercially successful. All pharmaceutical and medical device products in the United States, Europe and other countries must be manufactured in strict compliance with cGMP and other applicable regulatory standards. Establishing a cGMP-compliant process to manufacture pharmaceutical products involves significant time, cost and uncertainty. Furthermore, in order to be commercially viable, any such process would have to yield product on a cost-effective basis, using raw materials that are commercially available on acceptable terms. We face the risk that our contract manufacturers may have interruptions in raw material supplies, be unable to comply with strictly enforced regulatory requirements, or, for other reasons beyond their or our control, be unable to complete their manufacturing responsibilities on time, on budget, or at all. Under our collaboration agreement with Astellas, Astellas is responsible for all manufacture of MDV3100 for commercial purposes, but we cannot guarantee that Astellas will be able to supply MDV3100 in a timely manner or at all. Furthermore, commercial manufacturing processes have not yet been validated for MDV3100. We thus cannot guarantee that commercial-scale cGMP manufacture of MDV3100 will be possible, on a cost-effective basis or at all, which would materially and adversely affect the value of these programs.
We may be subject to product liability or other litigation, which could result in an inefficient allocation of our critical resources, delay the implementation of our business strategy and, if successful, materially and adversely harm our business and financial condition as a result of the costs of liabilities that may be imposed thereby. Our business exposes us to the risk of product liability claims that is inherent in the development of pharmaceutical products. If MDV3100 or any potential future product candidate harms people, or is alleged to be harmful, we may be subject to costly and damaging product liability claims brought against us by clinical trial participants, consumers, health care providers, corporate partners or others. We have product liability insurance covering our ongoing clinical trials, but do not have insurance for any of our other development activities. If we are unable to obtain insurance at an acceptable cost or otherwise protect against potential product liability claims, we may be exposed to significant litigation costs and liabilities, which may materially and adversely affect our business and financial position. If we are sued for injuries allegedly caused by any of our product candidates, our litigation costs and liability could exceed our total assets and our ability to pay. In addition, we may from time to time become involved in various lawsuits and legal proceedings which arise in the ordinary course of our business. Any litigation to which we are subject, including the purported securities class action lawsuits described in the section entitled Legal Proceedings under Part I, Item 3 of this Annual Report, could require significant involvement of our senior management and may divert managements attention from our business and operations. Litigation costs or an adverse result in any litigation that may arise from time to time may adversely impact our operating results or financial condition.
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Risks Related to Intellectual Property
Intellectual property protection for our product candidates is crucial to our business, and is subject to a significant degree of legal risk, particularly in the life sciences industry. The success of our business will depend in part on our ability to obtain and maintain intellectual property protectionprimarily patent protectionof our technologies and MDV3100 and any potential future product candidates, as well as successfully defending these patents against third-party challenges. We and our collaborators will only be able to protect our technologies and product candidates from unauthorized use by third parties to the extent that valid and enforceable patents or trade secrets cover them. Furthermore, the degree of future protection of our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us or our potential future collaborators to gain or keep our competitive advantage.
The patent positions of life sciences companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. Further, changes in either the patent laws or in interpretations of patent laws in the United States or other countries may diminish the value of our intellectual property rights. Accordingly, we cannot predict the breadth of claims that may be granted or enforced for our patents or for third-party patents that we have licensed. For example:
| we or our licensors might not have been the first to make the inventions covered by each of our pending patent applications and issued patents; |
| we or our licensors might not have been the first to file patent applications for these inventions; |
| others may independently develop similar or alternative technologies or duplicate any of our technologies; |
| it is possible that none of our pending patent applications or the pending patent applications of our licensors will result in issued patents; |
| our issued patents and future issued patents, or those of our licensors, may not provide a basis for protecting commercially viable products, may not provide us with any competitive advantages, or may be challenged by third parties and invalidated or rendered unenforceable; and |
| we may not develop additional proprietary technologies or product candidates that are patentable. |
Our existing and any future patent rights may not adequately protect MDV3100 or any potential future product candidates, which could prevent us from ever generating any revenues or profits. We cannot guarantee that any of our pending or future patent applications will mature into issued patents, or that any of our current or future issued patents will adequately protect MDV3100 or any potential future product candidates from competitors. For example, there is a large body of prior art, including multiple issued patents and published patent applications, disclosing molecules in the same chemical class as our licensed MDV300 series compounds. Since our licensed MDV300 series compounds include approximately 170 specific molecules, we expect that some members of this series may not be patentable in light of this prior art, or may infringe the claims of patents presently issued or issued in the future. Furthermore, we cannot guarantee that any of our present or future issued patents will not be challenged by third parties, or that they will withstand any such challenge. If we are not able to obtain adequate protection for, or defend, the intellectual property position of our technologies and product candidates, then we may not be able to attract collaborators to acquire or partner our development programs. Further, even if we can obtain protection for and defend the intellectual property position of our technologies and product candidates, we or any of our potential future collaborators still may not be able to exclude competitors from developing or marketing competing drugs. Should this occur, we and our potential future collaborators may not generate any revenues or profits from our product candidates or our revenue or profits would be significantly decreased.
We could become subject to litigation or other challenges regarding intellectual property rights, which could divert management attention, cause us to incur significant costs, prevent us from selling or using the challenged technology and/or subject us to competition by lower priced generic products. In recent years, there
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has been significant litigation in the United States and elsewhere involving pharmaceutical patents and other intellectual property rights. In particular, generic pharmaceutical manufacturers have been very aggressive in challenging the validity of patents held by proprietary pharmaceutical companies, especially if these patents are commercially significant. If MDV3100 or any future product candidates succeed, we may face similar challenges to our existing or future patents. If a generic pharmaceutical company or other third party were able to successfully invalidate any of our present or future patents, MDV3100 and any potential future product candidates that may ultimately receive marketing approval could face additional competition from lower priced generic products that would result in significant price and revenue erosion and have a significantly negative impact on the commercial viability of the affected product candidate(s).
In the future, we may be a party to litigation to protect our intellectual property or to defend our activities in response to alleged infringement of a third partys intellectual property. These claims and any resulting lawsuit, if successful, could subject us to significant liability for damages and invalidation, or a narrowing of the scope, of our proprietary rights. These lawsuits, regardless of their success, would likely be time-consuming and expensive to litigate and resolve and would divert management time and attention. Any potential intellectual property litigation also could force us to do one or more of the following:
| discontinue our products that use or are covered by the challenged intellectual property; or |
| obtain from the owner of the allegedly infringed intellectual property right a license to sell or use the relevant technology, which license may not be available on reasonable terms, or at all. |
If we are forced to take any of these actions, our business may be seriously harmed. Although we carry general liability insurance, our insurance does not cover potential claims of this type.
In addition, our patents and patent applications, or those of our licensors, could face other challenges, such as interference proceedings, opposition proceedings and re-examination proceedings. Any such challenge, if successful, could result in the invalidation of, or in a narrowing of the scope of, any of our patents and patent applications subject to the challenge. Any such challenges, regardless of their success, would likely be time-consuming and expensive to defend and resolve and would divert our managements time and attention.
We may in the future initiate claims or litigation against third parties for infringement in order to protect our proprietary rights or to determine the scope and validity of our proprietary rights or the proprietary rights of competitors. These claims could result in costly litigation and the diversion of our technical and management personnel and we may not prevail in making these claims.
We rely on license agreements for certain aspects of our product candidates and our technology. We may in the future need to obtain additional licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms, and which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated. We have entered into agreements with third-party commercial and academic institutions to license intellectual property rights and technology for use in our product candidates. For example, we have a license agreement with UCLA pursuant to which we were granted exclusive worldwide rights to certain UCLA patents related to our MDV300 series compounds. Some of these license agreements, including our license agreement with UCLA, contain diligence and milestone-based termination provisions, in which case our failure to meet any agreed upon diligence requirements or milestones may allow the licensor to terminate the agreement. If our licensors terminate our license agreements or if we are unable to maintain the exclusivity of our exclusive license agreements, we may be unable to continue to develop and commercialize MDV3100 or any potential future product candidates based on licensed intellectual property rights and technology.
From time to time we may be required to license technology from additional third parties to develop MDV3100 and any future product candidates. For example, the commercial scale manufacturing processes that we are developing for MDV3100 may require licenses to third-party technology. Should we be required to obtain
26
licenses to any third-party technology, including any such patents based on biological activities or required to manufacture our product candidates, such licenses may not be available to us on commercially reasonable terms, or at all. The inability to obtain any third-party license required to develop any of our product candidates could cause us to abandon any related development efforts, which could seriously harm our business and operations.
We may become involved in disputes with Astellas or any potential future collaborators over intellectual property ownership, and publications by our research collaborators and scientific advisors could impair our ability to obtain patent protection or protect our proprietary information, which, in either case, could have a significant impact on our business. Inventions discovered under research, material transfer or other such collaboration agreements, including our collaboration agreement with Astellas, may become jointly owned by us and the other party to such agreements in some cases and the exclusive property of either party in other cases. Under some circumstances, it may be difficult to determine who owns a particular invention, or whether it is jointly owned, and disputes could arise regarding ownership of those inventions. These disputes could be costly and time consuming and an unfavorable outcome could have a significant adverse effect on our business if we were not able to protect or license rights to these inventions. In addition, our research collaborators and scientific advisors generally have contractual rights to publish our data and other proprietary information, subject to our prior review. Publications by our research collaborators and scientific advisors containing such information, either with our permission or in contravention of the terms of their agreements with us, may impair our ability to obtain patent protection or protect our proprietary information, which could significantly harm our business.
Trade secrets may not provide adequate protection for our business and technology. We also rely on trade secrets to protect our technology, especially where we believe patent protection is not appropriate or obtainable. However, trade secrets are difficult to protect. While we use reasonable efforts to protect our trade secrets, our or any potential collaborators employees, consultants, contractors or scientific and other advisors may unintentionally or willfully disclose our information to competitors. If we were to enforce a claim that a third party had illegally obtained and was using our trade secrets, our enforcement efforts would be expensive and time consuming, and the outcome would be unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, if our competitors independently develop equivalent knowledge, methods or know-how, it will be more difficult or impossible for us to enforce our rights and our business could be harmed.
Risks Related to Ownership of Our Common Stock
We have been named as a defendant in a purported securities class action lawsuit. This lawsuit could result in substantial damages and may divert managements time and attention from our business and operations. In March 2010, the first of several putative securities class action lawsuits was commenced in the U.S. District Court for the Northern District of California, naming as defendants us and certain of our officers. The lawsuits are largely identical and allege violations of the Securities Exchange Act of 1934, as amended. The plaintiffs allege, among other things, that we disseminated false and misleading statements about the effectiveness of dimebon for the treatment of Alzheimers disease. The plaintiffs purport to seek damages, an award of their costs and injunctive relief on behalf of a class of stockholders who purchased or otherwise acquired our common stock between September 21, 2006 and March 2, 2010. The actions were consolidated in September 2010 and, in April 2011, the court entered an order appointing Catoosa Fund, L.P. and its attorneys as lead plaintiff and lead counsel. Thereafter, the lead plaintiff filed a consolidated amended complaint, which was dismissed without prejudice as to all defendants in August 2011. The lead plaintiff filed a second amended complaint in November 2011. In January 2012, we filed a motion to dismiss the second amended complaint, which is scheduled to be heard by the Court on March 16, 2012.
Our management believes that we have meritorious defenses and intends to defend this lawsuit vigorously. However, this lawsuit is subject to inherent uncertainties, and the actual cost will depend upon many unknown factors. The outcome of the litigation is necessarily uncertain, we could be forced to expend significant resources in the defense of the suit and we may not prevail. Monitoring and defending against legal actions is time
27
consuming for our management and detracts from our ability to fully focus our internal resources on our business activities. In addition, we may incur substantial legal fees and costs in connection with the litigation and, although we believe the Company is entitled to coverage under the relevant insurance policies, subject to a $350,000 retention, coverage could be denied or prove to be insufficient. We are not currently able to estimate the possible cost to us from this matter, as this lawsuit is currently at an early stage and we cannot be certain how long it may take to resolve this matter or the possible amount of any damages that we may be required to pay. We have not established any reserves for any potential liability relating to this lawsuit. It is possible that we could, in the future, incur judgments or enter into settlements of claims for monetary damages. A decision adverse to our interests on these actions could result in the payment of substantial damages, or possibly fines, and could have a material adverse effect on our cash flow, results of operations and financial position. In addition, the uncertainty of the currently pending litigation could lead to more volatility in our stock price.
Our stock price may be volatile, and our stockholders investment in our stock could decline in value. The market prices for our securities and those of other life sciences companies have been highly volatile and may continue to be highly volatile in the future. The following factors, in addition to other risk factors described in this Annual Report, may have a significant impact on the market price of our common stock:
| the receipt or failure to receive the additional funding necessary to conduct our business; |
| the progress and results of preclinical studies and clinical trials of our product candidates conducted by us, Astellas or any future collaborative partners or licensees, if any, and any delays in enrolling a sufficient number of patients to complete clinical trials of our product candidates; |
| the announcement by our competitors of results from clinical trials of their products or product candidates; |
| selling by existing stockholders and short-sellers; |
| announcements of technological innovations or new commercial products by our competitors or us; |
| developments concerning proprietary rights, including patents; |
| developments concerning our collaboration with Astellas or any future collaborations; |
| publicity regarding us, our product candidates or those of our competitors, including research reports published by securities analysts; |
| regulatory developments in the United States and foreign countries; |
| litigation, including the purported securities class action lawsuits pending against us and certain of our officers; |
| economic and other external factors or other disaster or crisis; and |
| period-to-period fluctuations in financial results. |
We do not intend to pay dividends on our common stock for the foreseeable future. We do not expect for the foreseeable future to pay dividends on our common stock. Any future determination to pay dividends on or repurchase shares of our common stock will be at the discretion of our board of directors and will depend upon, among other factors, our success in completing sales or partnerships of our programs, our results of operations, financial condition, capital requirements, contractual restrictions and applicable law.
Our principal stockholders exert substantial influence over us and may exercise their control in a manner adverse to your interests. Certain stockholders and their affiliates own a substantial amount of our outstanding common stock. These stockholders may have the power to direct our affairs and be able to determine the outcome of certain matters submitted to stockholders for approval. Because a limited number of persons controls us, transactions could be difficult or impossible to complete without the support of those persons. Subject to applicable law, it is possible that these persons will exercise control over us in a manner adverse to your interests.
28
Provisions of our charter documents, our stockholder rights plan and Delaware law could make it more difficult for a third party to acquire us, even if the offer may be considered beneficial by our stockholders. Provisions of the Delaware General Corporation Law could discourage potential acquisition proposals and could delay, deter or prevent a change in control. The anti-takeover provisions of the Delaware General Corporation Law impose various impediments to the ability of a third party to acquire control of us, even if a change in control would be beneficial to our existing stockholders. Specifically, Section 203 of the Delaware General Corporation Law, unless its application has been waived, provides certain default anti-takeover protections in connection with transactions between us and an interested stockholder. Generally, Section 203 prohibits stockholders who, alone or together with their affiliates and associates, own more than 15% of the subject company from engaging in certain business combinations for a period of three years following the date that the stockholder became an interested stockholder of such subject company without approval of the board or the vote of two-thirds of the shares held by the independent stockholders. Our board of directors has also adopted a stockholder rights plan, or poison pill, which would significantly dilute the ownership of a hostile acquirer. Additionally, provisions of our amended and restated certificate of incorporation and bylaws could deter, delay or prevent a third party from acquiring us, even if doing so would benefit our stockholders, including without limitation, the authority of the board of directors to issue, without stockholder approval, preferred stock with such terms as the board of directors may determine.
Future sales of our common stock in the public market could cause our stock price to fall. Sales of a substantial number of shares of our common stock in the public market that were previously restricted from sale, or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. In the event that we do raise capital through the sale of additional equity securities or debt convertible into equity securities, the dilution represented by the additional shares of our equity securities in the public market could cause our stock price to fall, in which case investors may not be able to sell their shares of our equity securities at a price equal to or above the price they paid to acquire them.
Item 1B. | Unresolved Staff Comments. |
None.
Item 2. | Properties. |
Our corporate headquarters are currently located at 201 Spear Street, San Francisco, California, where we lease approximately 34,000 square feet of office space pursuant to lease agreements that expire in July 2012 and May 2013.
In December 2011, we entered into a lease agreement for approximately 57,000 square feet of office space located at 525 Market Street, San Francisco, California, which is intended to serve as our future corporate headquarters following construction and build-out. The term of the lease is for seven years, with an anticipated commencement date of June 2012. We have an option to extend the term of the lease for an additional five years.
In February 2012, we entered into a lease agreement for 15,336 square feet of office space located in Oakbrook Terrace, Illinois, which is intended to serve as our commercial headquarters following construction and build-out. We selected this location for our commercial headquarters based on its proximity to our collaboration partner, Astellas. The term of the lease is seven years and seven months, with an anticipated commencement date of May 2012.
We believe our properties are adequately maintained and suitable for their intended use. We continually evaluate our properties and believe that our current facilities plus any planned expansion are generally sufficient to meet our expected needs and near-term growth.
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Item 3. | Legal Proceedings. |
In March 2010, the first of several putative securities class action lawsuits was commenced in the U.S. District Court for the Northern District of California, naming as defendants us and certain of our officers. The lawsuits are largely identical and allege violations of the Securities Exchange Act of 1934, as amended. The plaintiffs allege among other things that we disseminated false and misleading statements about the effectiveness of dimebon for the treatment of Alzheimers disease. The plaintiffs purport to seek damages, an award of their costs and injunctive relief on behalf of a class of stockholders who purchased or otherwise acquired our common stock between September 21, 2006 and March 2, 2010. The actions were consolidated in September 2010, and, in April 2011 the court entered an order appointing Catoosa Fund, L.P. and its attorneys as lead plaintiff and lead counsel. Thereafter, the lead plaintiff filed a consolidated, amended complaint, which was dismissed without prejudice as to all defendants in August 2011. The lead plaintiff filed a second amended complaint in November 2011. In January 2012, we filed a motion to dismiss the second amended complaint, which is scheduled to be heard by the Court on March 16, 2012.
Our management believes that we have meritorious defenses and intends to defend this lawsuit vigorously. However, this lawsuit is subject to inherent uncertainties, the actual cost may be significant, and we may not prevail. We believe we are entitled to coverage under our relevant insurance policies, subject to a $350,000 retention, but coverage could be denied or prove to be insufficient.
Item 4. | Mine Safety Disclosures. |
None.
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PART II
Item 5. | Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. |
Market Information
Our common stock, par value $0.01, is listed on the NASDAQ Global Market under the symbol MDVN. The following table sets forth on a per share basis the high and low intraday sales prices of our common stock as reported by the NASDAQ Global Market:
High | Low | |||||||
2011: |
||||||||
Quarter ended March 31, 2011 |
$ | 19.84 | $ | 13.27 | ||||
Quarter ended June 30, 2011 |
$ | 25.50 | $ | 18.71 | ||||
Quarter ended September 30, 2011 |
$ | 22.97 | $ | 14.32 | ||||
Quarter ended December 31, 2011 |
$ | 49.66 | $ | 15.51 | ||||
2010: |
||||||||
Quarter ended March 31, 2010 |
$ | 40.49 | $ | 10.47 | ||||
Quarter ended June 30, 2010 |
$ | 12.25 | $ | 8.79 | ||||
Quarter ended September 30, 2010 |
$ | 13.13 | $ | 8.43 | ||||
Quarter ended December 31, 2010 |
$ | 16.68 | $ | 10.96 |
Stockholders
As of the close of business on February 22, 2012, there were 23 stockholders of record of our common stock and the last reported sales price per share of our common stock was $65.08. The number of stockholders of record is based upon the actual number of stockholders registered at such date and does not include holders of shares in street names or persons, partnerships, associates, or corporations, or other entities identified in security listings maintained by depositories.
Dividends
We have never paid our stockholders cash dividends and we do not anticipate paying any cash dividends in the foreseeable future as we intend to retain all of our cash for use in our business. Any future determination to pay dividends will be at the discretion of our Board of Directors, and will depend on a number of factors, including but not limited to any outstanding indebtedness, earnings, capital requirements, financial condition and future prospects, and applicable Delaware law.
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Performance Graph
We have presented below the cumulative total return to our stockholders during the period from December 31, 2006 through December 31, 2011 in comparison to the cumulative total return of the NASDAQ Composite Index and the NASDAQ Biotechnology Index. All values assume a $100 initial investment and the reinvestment of the full amount of all dividends and are calculated as of the last stock trading day of each year. The comparisons are based on historical data and are not indicative of, nor intended to forecast, the future performance of our common stock.
2006 | 2007 | 2008 | 2009 | 2010 | 2011 | |||||||||||||||||||
Medivation, Inc. |
$ | 100 | $ | 91.02 | $ | 92.10 | $ | 237.99 | $ | 95.89 | $ | 291.46 | ||||||||||||
NASDAQ Composite Index |
$ | 100 | $ | 110.65 | $ | 66.42 | $ | 96.54 | $ | 114.07 | $ | 113.17 | ||||||||||||
NASDAQ Biotechnology Index |
$ | 100 | $ | 104.64 | $ | 91.77 | $ | 106.42 | $ | 122.62 | $ | 137.42 |
The information under Performance Graph is not deemed to be soliciting material or filed with the Securities and Exchange Commission or subject to Regulation 14A or 14C, or to the liabilities of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference in any filing of Medivation under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K and irrespective of any general incorporation language in those filings.
Recent Sales of Unregistered Securities
None.
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Item 6. | Selected Financial Data. |
The following is a summary of our historical consolidated financial data for the years ended and on the dates indicated below. The historical consolidated financial data for the years ended December 31, 2011, 2010 and 2009 and as of December 31, 2011 and 2010 have been derived from our audited consolidated financial statements included in Item 15 of this Annual Report. The historical financial data for the years ended December 31, 2008 and 2007 and as of December 31, 2009, 2008 and 2007 have been derived from our audited consolidated financial statements not included in this Annual Report. The information below is not necessarily indicative of results of future operations, and should be read in conjunction with Item 7, Managements Discussion and Analysis of Financial Condition and Results of Operations, and the consolidated financial statements and related notes thereto included in Item 15 of this Annual Report to fully understand factors that may affect the comparability of the information presented below.
Years Ended December 31, | ||||||||||||||||||||
2011 | 2010 | 2009 | 2008 | 2007 | ||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||||||
Consolidated Statements of Operations Data: |
||||||||||||||||||||
Collaboration revenue |
$ | 60,389 | $ | 62,508 | $ | 69,254 | $ | 12,578 | $ | | ||||||||||
Operating expenses: |
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Research and development |
73,432 | 72,228 | 87,728 | 54,895 | 23,399 | |||||||||||||||
Selling, general and administrative |
29,887 | 23,005 | 28,983 | 21,865 | 10,364 | |||||||||||||||
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Total operating expenses |
103,319 | 95,233 | 116,711 | 76,760 | 33,763 | |||||||||||||||
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Loss from operations |
(42,930 | ) | (32,725 | ) | (47,457 | ) | (64,182 | ) | (33,763 | ) | ||||||||||
Other (expense) income, net |
(242 | ) | 260 | 976 | 1,712 | 2,022 | ||||||||||||||
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Net loss before income tax (benefit) expense |
(43,172 | ) | (32,465 | ) | (46,481 | ) | (62,470 | ) | (31,741 | ) | ||||||||||
Income tax (benefit) expense |
(4,331 | ) | 1,572 | 8,272 | (10 | ) | 2 | |||||||||||||
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Net loss |
$ | (38,841 | ) | $ | (34,037 | ) | $ | (54,753 | ) | $ | (62,460 | ) | $ | (31,743 | ) | |||||
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Basic and diluted net loss per common share |
$ | (1.11 | ) | $ | (0.99 | ) | $ | (1.71 | ) | $ | (2.12 | ) | $ | (1.14 | ) | |||||
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Weighted-average common shares used in the calculation of basic and diluted net loss per common share |
34,960 | 34,290 | 32,094 | 29,478 | 27,932 | |||||||||||||||
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December 31, | ||||||||||||||||||||
2011 | 2010 | 2009 | 2008 | 2007 | ||||||||||||||||
(in thousands) | ||||||||||||||||||||
Consolidated Balance Sheet Data: |
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Cash and cash equivalents |
$ | 70,136 | $ | 107,717 | $ | 57,463 | $ | 71,454 | $ | 43,258 | ||||||||||
Short-term investments |
74,996 | 100,039 | 220,781 | 149,968 | | |||||||||||||||
Working capital |
78,555 | 148,037 | 189,813 | 149,584 | 40,214 | |||||||||||||||
Total assets |
175,117 | 239,603 | 296,690 | 229,272 | 45,596 | |||||||||||||||
Deferred revenue |
143,271 | 200,660 | 253,168 | 212,423 | | |||||||||||||||
Accumulated deficit |
(250,291 | ) | (211,450 | ) | (177,413 | ) | (122,660 | ) | (60,200 | ) | ||||||||||
Total stockholders equity |
1,321 | 7,684 | 25,274 | 3,408 | 41,058 |
Item 7. | Managements Discussion and Analysis of Financial Condition and Results of Operations. |
The following discussion and analysis should be read in conjunction with our audited consolidated financial statements and notes thereto for the fiscal year ended December 31, 2011 included elsewhere in this Annual Report. The following discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. We intend that these forward-looking
33
statements be subject to the safe harbors created by those provisions. Forward-looking statements are generally written in the future tense and/or are preceded by words such as may, should, forecast, could, expect, suggest, believe, anticipate, intend, plan, or other similar words, or the negatives of such terms or other variations on such terms or comparable terminology. The forward-looking statements contained in this Annual Report involve a number of risks and uncertainties, many of which are outside of our control. Factors that could cause actual results to differ materially from projected results include, but are not limited to, those discussed in Risk Factors included elsewhere in this Annual Report. Readers are expressly advised to review and consider those Risk Factors, which include risks associated with (1) the effects of competing and alternative treatments on patient enrollment and retention in and the results of our ongoing and planned clinical trials, including our ongoing PREVAIL trial, (2) our ability to successfully launch and obtain reimbursement on acceptable terms for MDV3100, and to compete successfully against approved agents proven to extend life, should MDV3100 receive marketing approval for post-chemotherapy advanced prostate cancer patients; (3) our ability to successfully conduct clinical and preclinical trials for our product candidates, (4) our ability to obtain and maintain required regulatory approvals to develop and market our product candidates, (5) our ability to raise additional capital on favorable terms, (6) our ability to execute our development plan on time and on budget, (7) our ability to obtain commercial partners and maintain our relationships with our current and/or potential partners, (8) our ability, whether alone or with commercial partners, to successfully commercialize any of our product candidates that may be approved for sale, and (9) our ability to identify and obtain additional product candidates. Although we believe that the assumptions underlying the forward-looking statements contained in this Annual Report are reasonable, any of the assumptions could be inaccurate, and therefore there can be no assurance that such statements will be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by us or any other person that the results or conditions described in such statements or our objectives and plans will be achieved. Furthermore, past performance in operations and share price is not necessarily indicative of future performance. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Overview
We are a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Together with our collaboration partner, Astellas Pharma, Inc., or Astellas, we are developing MDV3100 for multiple stages of advanced prostate cancer. We have successfully completed the Phase 3 AFFIRM trial in the latest stage patientsthose who have already failed docetaxel-based chemotherapyand we are conducting an additional Phase 3 trial and two Phase 2 trials in men with earlier stages of advanced prostate cancer. Based on the positive results of the AFFIRM trial, we have exercised our right under our collaboration agreement with Astellas, or the Astellas Collaboration Agreement, to co-promote MDV3100 in the U.S., should it receive marketing approval. We and Astellas expect to file applications for marketing approval for MDV3100 both in the U.S. and in Europe in 2012. MDV3100 has received Fast Track designation from the FDA for the post-docetaxel indication.
In October 2009, we entered into the Astellas Collaboration Agreement. Under the terms of the agreement, we and Astellas share equally the costs of developing and commercializing MDV3100 for the United States market (subject to the exceptions noted below), and we and Astellas will share equally profits (or losses) resulting from the commercialization of MDV3100 in the United States. Costs of clinical trials supporting development in both the United States and in either Europe or Japan are borne two-thirds by Astellas and one-third by us. Both we and Astellas will be responsible for all costs incurred in fielding and supporting our respective MDV3100 sales forces, and each of us will be entitled to receive a fee for each detail made by our respective sales forces. Outside the United States, Astellas will bear all development and commercialization costs and will pay us tiered, double-digit royalties on the aggregate net sales of MDV3100.
In January 2012, we reported negative top line results from our Phase 3 CONCERT trial of our product candidate dimebon in patients with mild-to-moderate Alzheimers disease. We previously had reported negative
34
top line results from our Phase 3 CONNECTION trial of dimebon in patients with mild-to-moderate Alzheimers disease and our Phase 3 HORIZON trial of dimebon in patients with Huntington disease. In January 2012, Pfizer, Inc., or Pfizer, exercised its right to terminate our collaboration agreement for the development and commercialization of dimebon and we and Pfizer discontinued development of dimebon for all indications. During the ensuing 180 days, we and Pfizer will work together to wind down our respective remaining collaboration activities.
Our MDV300 Series Prostate Cancer Program
We have obtained an exclusive, worldwide commercial license to a series of novel small molecules, referred to as the MDV300 series compounds. Our lead development candidate from the MDV300 series is a molecule we refer to as MDV3100. A description of our completed and ongoing clinical trials is included below.
Completed Clinical Trials
Phase 3 AFFIRM Trial
In November 2011, we reported positive results from a planned interim analysis of the AFFIRM trial, a randomized, double-blind Phase 3 trial evaluating MDV3100 (160 mg once daily) versus placebo in 1,199 patients with advanced prostate cancer who had previously failed docetaxel-based chemotherapy. The primary endpoint of the AFFIRM trial was overall survival. The Independent Data Monitoring Committee, or IDMC, overseeing the AFFIRM trial determined that MDV3100 demonstrated a clinically meaningful and statistically significant (p<0.0001) improvement in overall survival compared to placebo, and as a result recommended that the study be stopped early and men who received placebo be offered MDV3100. The IDMC informed us that 1) MDV3100 produced a 4.8-month advantage in median survival compared to placebo; 2) the estimated median survival for men treated with MDV3100 was 18.4 months compared to 13.6 months for men treated with placebo; and 3) MDV3100 provided a 37% reduction in risk of death compared to placebo (hazard ratio = 0.631). The IDMC further determined, considering the observed safety profile, that MDV3100 demonstrated a favorable risk-to-benefit ratio sufficient to stop the study.
In February 2012, we reported further results from the AFFIRM trial at the American Society of Clinical Oncologys 2012 Genitourinary Cancers Symposium, or ASCO GU. In addition to confirming the results reported in November 2011, we reported that MDV3100 had achieved all of the trials secondary endpoints with strong statistical significance and was well tolerated. As compared to patients taking placebo, MDV3100 patients in the AFFIRM trial experienced longer median radiographic progression-free survival (8.3 versus 2.9 months; p<0.0001; hazard ratio = 0.404), a higher soft tissue response rate (28.9% versus 3.8%; p<0.0001), and longer median time to prostate-specific antigen, or PSA, progression (8.3 versus 3.0 months; p<0.0001; hazard ratio = 0.249). PSA declines of 50% or greater were more common in the MDV3100 group than in the placebo group (54.0% versus 1.5%; p<0.0001), as were PSA declines of 90% or greater (24.8% versus 0.9%; p<0.0001).
MDV3100 was well tolerated in the AFFIRM trial. Common side effects included fatigue, diarrhea and hot flush. Serious adverse events, adverse events causing patients to stop treatment, and adverse events causing death all were lower in the MDV3100 group than in the placebo group. Serious side effects of interest were fatigue (6.3% in the MDV3100 group versus 7.3% in the placebo group), cardiac disorders (0.9% versus 2.0%) including myocardial infarction (0.3% versus 0.5%), seizure (0.6% versus 0.0%) and liver function test abnormalities (0.4% versus 0.8%). The period during which AFFIRM patients were followed for safety issues was more than twice as long for MDV3100 patients (9.3 months) as compared to placebo patients (4.0 months).
The FDA has granted Fast Track designation for the development of MDV3100 in the post-chemotherapy indication, a designation that is reserved for development programs that the FDA determines to be for a life-threatening condition with unmet medical need. Receipt of Fast Track designation enables us to request that the FDA grant us priority review for our anticipated new drug application, or NDA, in post-chemotherapy patients. In considering requests for priority review, the FDA applies the same standard it uses to award Fast Track designation. We plan to hold a pre-NDA meeting with the FDA in early 2012. We and Astellas expect to file
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both an NDA with the FDA and a marketing authorization application, or MAA, with the European Medicines Agency in 2012 seeking approval to market MDV3100 for post-docetaxel advanced prostate cancer in the U.S. and Europe, respectively.
Based on the positive results from the AFFIRM trial, we elected to exercise our right under the Astellas Collaboration Agreement to co-promote MDV3100 in the U.S. market. Should MDV3100 receive marketing approval, we will provide 50% of the sales and medical affairs support for MDV3100 in the U.S. market.
Phase 1-2 Trial
In December 2008, we completed enrollment in an open-label Phase 1-2 clinical trial of MDV3100 in patients with castration resistant prostate cancer, or CRPC. We enrolled 140 patients in seven dose groups, ranging from 30 mg/day to 600 mg/day. Of the 140 patients, 75 had previously failed docetaxel-based chemotherapy and 65 were chemotherapy-naïve. All 140 patients also had failed at least one line of prior hormonal therapy. The study endpoints include safety, tolerability, pharmacokinetics, circulating tumor cell, or CTC, counts, PSA levels, radiographic change in soft tissue and bony metastases, and time to progression.
Data from this trial were published in The Lancet in 2010. These data showed that MDV3100 consistently demonstrated anti-tumor activity across endpoints, as evaluated by reductions in PSA levels, radiographic findings and CTC counts. This activity was consistently stronger in the earlier stage (i.e. chemotherapy naïve) as compared to the later stage (i.e., post-chemotherapy) patients. Key efficacy data as reported in The Lancet were as follows:
Chemotherapy-Naïve Patients | Post-Chemotherapy Patients | |||||||
PSA decline ³ 50% from baseline |
62 | % | 51 | % | ||||
Radiographic control: soft-tissue lesions (partial response or stable disease) |
80 | % | 65 | % | ||||
Radiographic control: bony lesions (stable disease) |
63 | % | 51 | % | ||||
CTC conversion from poor prognosis to good prognosis |
75 | % | 37 | % |
In February 2011, we presented new long-term follow-up data covering all 140 patients enrolled in the trial at 2011ASCO GU. PSA progression data reported at 2011 ASCO GU were calculated using three distinct reporting criteria: the criteria specified in the Phase 1-2 trial protocol; the most recent published PSA reporting consensus criteria (the Prostate Cancer Clinical Trials Working Group 2, or PCWG2, criteria); and an older commonly used reporting method (the Prostate-Specific Antigen Working Group 1, or PSAWG1, criteria). Key efficacy data as presented at 2011 ASCO GU were as follows:
Chemotherapy Naïve Patients | Post-Chemotherapy Patients | |||
Median time to PSA progression (per protocol criteria) |
Not reached | 316 days (45 weeks) | ||
Median time to PSA progression (per PCWG2 criteria) |
281 days (40 weeks) |
148 days (21 weeks) | ||
Median time to PSA progression (per PSAWG1 criteria) |
420 days (60 weeks)* 812 days (116 weeks)** |
166 days (24 weeks) | ||
Median time to radiographic progression |
394 days (56 weeks) |
173 days (25 weeks) |
* | All chemotherapy-naïve patients |
** | Subpopulation of chemotherapy-naïve patients who were also ketoconazole-naïve |
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MDV3100 was well tolerated in this trial at doses up to and including 240 mg/day. The most frequently reported adverse event was fatigue. Seizures were observed in two patients, one each at doses of 600 and 360 mg/day. Both patients were taking concomitant medications that can cause seizures. A possible but unwitnessed seizure was reported in a patient taking a dose of 480 mg/day.
Ongoing Clinical Trials
Phase 3 PREVAIL Trial
PREVAIL is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating MDV3100 (160 mg once daily) versus placebo in approximately 1,700 patients with advanced prostate cancer who have not previously been treated with chemotherapy. The co-primary endpoints are progression-free survival and overall survival. We began enrollment in the PREVAIL trial in September 2010.
Phase 2 TERRAIN Trial
TERRAIN is a randomized, double-blind Phase 2 trial evaluating MDV3100 versus bicalutamide, the leading marketed anti-androgen drug, in approximately 370 advanced prostate cancer patients who have progressed following medical castration with a luteinizing hormone releasing hormone analog drug or surgical castration. The primary endpoint is progression-free survival. We began enrollment in the TERRAIN trial in March 2011.
Phase 2 Hormone-Naïve Trial
In May 2011, we initiated a Phase 2 trial evaluating MDV3100 in approximately 60 patients with advanced prostate cancer who have not had any previous hormonal treatment. This is the first trial to examine the effects of MDV3100 in the earlier-stage population of advanced prostate cancer patients who have not yet undergone medical or surgical castration. The primary endpoint in the trial is PSA response.
Financial History
We have not generated any revenue from product sales to date, and we may never generate any revenue from product sales. We have funded our operations primarily through private and public offerings of our common stock and from the up-front, development milestone and cost-sharing payments under our collaboration agreements.
We entered into a collaboration agreement with Astellas in October 2009, pursuant to which we received a non-refundable up-front cash payment of $110.0 million in the fourth quarter of 2009. We subsequently received development milestone payments of $10.0 million and $3.0 million in the fourth quarter of 2010 and the second quarter of 2011, respectively. We recorded development and commercialization cost-sharing payments from Astellas totaling $43.8 million, $34.6 million and $2.9 million during the years ended December 31, 2011, 2010 and 2009, respectively. Additional information regarding the Astellas Collaboration Agreement is included in the section titled, Managements Discussion and Analysis of Financial Condition and Results of OperationsLiquidity and Capital ResourcesAstellas Collaboration Agreement.
We entered into a collaboration agreement with Pfizer in October 2008, pursuant to which we received a non-refundable up-front cash payment of $225.0 million in the fourth quarter of 2008. We recorded development and commercialization cost-sharing payments from Pfizer totaling $12.4 million, $28.1 million and $19.7 million during the years ended December 31, 2011, 2010 and 2009, respectively. In January 2012, we reported negative top line results from our Phase 3 CONCERT trial of dimebon in patients with mild-to-moderate Alzheimers disease. We previously had reported negative top line results from our Phase 3 CONNECTION trial of dimebon in patients with mild-to-moderate Alzheimers disease and our Phase 3 HORIZON trial of dimebon in patients with Huntington disease. In January 2012, Pfizer exercised its right to terminate the collaboration agreement and
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we and Pfizer discontinued development of dimebon for all indications in 2012 as discussed in the section titled, Managements Discussion and Analysis of Financial Condition and Results of OperationsSubsequent EventsTermination of Pfizer Collaboration Agreement and Dimebon Program.
We have incurred cumulative net losses of $250.3 million through December 31, 2011, and we expect to incur substantial additional losses for the foreseeable future as we pursue regulatory approval for, and, if approved, commercial launch of, MDV3100 and continue to finance clinical and preclinical studies of our existing and potential future product candidates and our corporate overhead costs.
As of December 31, 2011, we had cash, cash equivalents and short-term investments totaling $145.1 million available to fund our operations. Based upon our current expectations, we believe our capital resources at December 31, 2011 will be sufficient to fund our currently planned operations for the next 12 months. This estimate is based on a number of assumptions that may prove to be wrong, and we could exhaust our available cash, cash equivalents, and short-term investments earlier than presently anticipated. We may be required or choose to seek additional capital within the next 12 months to expand our clinical development activities for MDV3100 based on the positive results of our Phase 3 AFFIRM trial in post-chemotherapy advanced prostate cancer patients, to fund costs of planning for and executing a commercial launch of MDV3100, should it receive marketing approval, if we face challenges or delays in connection with our clinical trials or the potential approval and commercialization of MDV3100, or to maintain minimum cash balances that we deem reasonable and prudent. In addition, we intend to evaluate the capital markets from time to time to determine whether to raise additional capital in the form of equity, convertible debt or otherwise, depending on market conditions relative to our need for funds at such time, and we may seek to raise additional capital within the next 12 months should we conclude that such capital is available on terms that we consider to be in the best interests of our company and our stockholders.
Subsequent Events
Termination of Pfizer Collaboration Agreement and Dimebon Program
In January 2012, we reported negative top line results from our Phase 3 CONCERT trial of dimebon in patients with mild-to-moderate Alzheimers disease. We previously had reported negative top line results from our Phase 3 CONNECTION trial of dimebon in patients with mild-to-moderate Alzheimers disease and our Phase 3 HORIZON trial of dimebon in patients with Huntington disease. In January 2012, Pfizer exercised its right to terminate the collaboration agreement and we and Pfizer discontinued development of dimebon for all indications. During the ensuing 180 days, we and Pfizer will work together to wind down our respective remaining collaboration activities.
We estimate that we and Pfizer will complete our respective collaboration wind down activities in the first half of 2012. Thus, during the first quarter of 2012 we revised our estimate of the remaining performance period under our former collaboration agreement with Pfizer. We expect the performance period to conclude in the first half of 2012. The remaining deferred revenue balance relating to the former collaboration agreement with Pfizer, which totaled $72.0 million at December 31, 2011, will be recognized as revenue over the remaining performance period.
Oakbrook Terrace Lease
In February 2012, we entered into a lease agreement for 15,336 square feet of office space located in Oakbrook Terrace, Illinois, which is intended to serve as our commercial headquarters following construction and build-out. The term of the lease is seven years and seven months, with an anticipated commencement date of May 2012. We selected this location for our commercial headquarters based on its proximity to our collaboration partner, Astellas. The annual non-cancelable rent payments are approximately $0.3 million per year. In connection with the execution of the lease, we delivered to the lessor a letter of credit collateralized by restricted cash totaling $0.8 million.
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Critical Accounting Policies and the Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States, or U.S. GAAP, requires that management make estimates and assumptions in certain circumstances that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from those estimates. A detailed description of our significant accounting policies is included in the footnotes to our audited consolidated financial statements included elsewhere in this Annual Report.
We believe that certain of our accounting policies are critical because they are the most important to the preparation of our consolidated financial statements. These policies require our most subjective and complex judgments, often requiring the use of estimates about the effects of matters that are inherently uncertain. We apply estimation methodologies consistent from year to year. Other than changes required due to the issuance of new accounting guidance, there have been no significant changes in our application of our critical accounting policies during the periods presented. The following is a summary of accounting policies that we consider critical to our consolidated financial statements.
Estimated Performance Periods under our Collaboration Agreements
Both the Astellas Collaboration Agreement and the former collaboration agreement with Pfizer contain multiple elements and deliverables, and required evaluation pursuant to the Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, 605-25 Revenue RecognitionMultiple-Element Arrangements. We evaluated the facts and circumstances of the collaboration agreements to determine whether we had obligations constituting deliverables under ASC 605-25. We concluded that we had multiple deliverables under both collaboration agreements, including deliverables relating to grants of technology licenses, and performance of manufacturing, regulatory and clinical development activities in the U.S. In the case of the Astellas Collaboration Agreement, the period in which we perform our deliverables began in the fourth quarter of 2009 and at December 31, 2011, management estimated that it would be completed in the fourth quarter of 2014. In the case of the former collaboration agreement with Pfizer, the period in which we perform our deliverables began in the fourth quarter of 2008 and at December 31, 2011, management estimated that it would be completed in the fourth quarter of 2013. We also concluded that our deliverables under each collaboration agreement should be accounted for as a single unit of accounting under ASC 605-25.
Estimation of the performance periods of our deliverables requires the use of our managements judgment. Significant factors considered in managements evaluation of the estimated performance period include, but are not limited to, our experience, along with Astellas and Pfizers experience, in conducting clinical development and regulatory activities. We review the estimated duration of our performance periods under both collaborations on a quarterly basis and make any appropriate adjustments on a prospective basis.
During the year ended December 31, 2010, we extended the estimated completion date of our performance period under the former collaboration agreement with Pfizer from the second quarter of 2012 to the fourth quarter of 2013, based on the failure of the CONNECTION trial and the resulting longer period required to complete the clinical trials evaluating dimebons potential safety and efficacy as a treatment for mild-to-moderate Alzheimers disease.
In January 2012, Pfizer exercised its right to terminate the collaboration agreement. As a result, during the first quarter of 2012, we revised our estimate of the remaining performance period under the collaboration agreement. We expect to complete our remaining performance obligations pursuant to the terms of the former collaboration agreement with Pfizer in the first half of 2012.
Future changes in estimates of either of the performance periods under our collaboration agreements could significantly impact the timing of future revenue recognized under the applicable collaboration agreement.
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Collaboration Agreement Payments
We account for the various payment flows under our collaboration agreements in a consistent manner, as follows:
Up-Front Payments. We received non-refundable up-front cash payments of $110.0 million and $225.0 million under our collaboration agreement with Astellas and our former collaboration agreement with Pfizer, respectively. We recognize these payments as revenue on a straight-line basis over the applicable estimated performance period.
Milestone Payments. We are eligible to receive milestone payments under the Astellas Collaboration Agreement based on achievement of specified development, regulatory and commercial events. Management evaluated the nature of the events triggering these contingent payments, and concluded that these eventsexcept for (a) those relating to regulatory activities in Europe, development and regulatory activities in Japan, and commercial activities, all of which are areas in which we have no pertinent contractual responsibilities, and (b) the initiation of our Phase 3 PREVAIL trial, an event which management deemed to be reasonably assured at the inception of the Astellas collaborationconstituted substantive milestones. This conclusion was based primarily on the facts that (i) each triggering event represents a specific outcome that can be achieved only through successful performance by us of one or more of our deliverables, (ii) achievement of each triggering event was subject to inherent risk and uncertainty and would result in additional payments becoming due to us, (iii) each of these milestones was substantive, based primarily on the facts that the payments they trigger are non-refundable, (iv) achievement of the milestone entails risk and was not reasonably assured at inception of the collaboration agreement, (v) substantial effort is required to complete each milestone, (vi) the amount of each milestone payment is reasonable in relation to the value created in achieving the milestone, (vii) a substantial amount of time is expected to pass between the up-front payment and the potential milestone payments, and (viii) the milestone payments relate solely to past performance. Based on the foregoing, we will recognize any revenue from these milestone payments under the substantive milestone method in the period in which the underlying triggering event occurs.
For the contingent payments triggered by events that do not constitute substantive milestones, management concluded that the appropriate revenue recognition treatment depends on whether the triggering event occurs during or after the performance period. Where the triggering event occurs during the applicable performance period, we will amortize any revenue from this event on a straight-line basis over the applicable performance period. Where the triggering event occurs after the applicable performance period, we will recognize the associated revenue in the period in which the event occurs.
Royalties and Profit Sharing Payments. Under the Astellas Collaboration Agreement, we are eligible to receive profit sharing payments on sales of products in the U.S. and royalties on sales of products outside the U.S. We will recognize any revenue from these events based on the revenue recognition criteria set forth in ASC 605-10-25-1, Revenue Recognition. Based on those criteria, we consider these potential payments to be contingent revenues, and will recognize them as revenue in the period in which the applicable contingency is resolved.
Cost-Sharing Payments. Under both the Astellas Collaboration Agreement and the former collaboration agreement with Pfizer, we and our collaboration partners share certain development and commercialization costs in the U.S. The parties make quarterly cost-sharing payments to one another in amounts necessary to ensure that each party bears its contractual share of the overall development and commercialization costs as incurred. Our policy is to account for cost-sharing payments to our collaboration partners as increases in expense in our consolidated statements of operations, while cost-sharing payments from our collaborative partners are presented as reductions in expense. Cost-sharing payments related to development activities and commercialization activities are recorded in research and development and selling, general and administrative expenses, respectively.
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Stock-Based Compensation
We have granted stock options, restricted stock units, performance share awards and stock appreciation rights pursuant to the terms of our Amended and Restated 2004 Equity Incentive Award Plan. We account for stock-based compensation awards granted to employees and directors in accordance with ASC 718, Stock Compensation, and have applied the provisions of the Securities and Exchange Commission, or the SEC, Staff Accounting Bulletin, or SAB, No. 107 and No. 110, in our application of ASC 718. Stock compensation arrangements with consultants are accounted for in accordance with ASC 718 and ASC 505-50, Equity-Based Payments to Non-Employees, using a fair value approach. The compensation costs of these arrangements are subject to re-measurement over the vesting terms as earned.
We determine stock-based compensation expense associated with stock options based on the estimated grant date fair value using the Black-Scholes valuation model, which requires the use of subjective assumptions related to expected stock price volatility, expected option term, expected dividend yield and risk-free interest rate. For employee and director stock options, we recognize compensation expense over the vesting period of the awards. Stock options granted to consultants are valued at their respective measurement dates and recognized as expense based on the portion of the total consulting services provided during the applicable period. As further consulting services are provided in each period, we revalue the associated awards and recognize additional expense based on their then-current fair values.
Stock-based compensation expense associated with restricted stock units is based on the fair value of our common stock on the grant date, which equals the closing market price of our common stock on the grant date of the award. For restricted stock units, we recognize compensation expense over the vesting period of the awards.
Performance share awards allow the recipients of such awards to earn fully vested shares of our common stock based on the achievement of pre-established performance objectives specified in the awards. Stock-based compensation expense associated with performance share awards is based on the estimated grant date fair value of our common stock using the Black-Scholes valuation model and is recognized based upon our best estimates of the achievement of the performance objectives specified in such awards and the resulting number of shares that are expected to be earned. We evaluate on a quarterly basis the probability of achieving the performance criteria. The cumulative effect on current and prior periods of a change in the estimated number of performance share awards expected to be earned is recognized as compensation expense or as reduction of previously recognized compensation expense in the period of the revised estimate.
The fair value of stock-settled and cash-settled stock appreciation rights is initially measured on the grant date using the Black-Scholes valuation model, which requires the use of subjective assumptions related to the expected stock price volatility, expected term, expected dividend yield and risk-free interest rate. Similar to stock options, compensation expense for stock-settled stock appreciation rights is recognized on a straight-line basis over the vesting period based on the grant-date fair value. Cash-settled stock appreciation rights are liability-classified awards for which compensation expense and the liability are remeasured at each reporting date through the date of settlement based on the portion of the requisite service period rendered.
We apply a forfeiture rate when determining stock-based compensation expense to account for an estimate of the granted awards not expected to vest. If actual forfeitures differ from the expected rate, we may be required to make additional adjustments to compensation expense in future periods.
The Black-Scholes valuation model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferrable; characteristics not present in our option grants. If the model permitted consideration of the unique characteristics of employee stock options and stock appreciation rights, the resulting estimate of the fair value of the stock options and stock appreciation rights could be different. In addition, if we had made different assumptions and estimates for use in the Black-Scholes valuation model, the amount of recognized and to be recognized stock-based compensation expense could have been different.
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Research and Development Expense and Accruals
Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services. Research and development costs are expensed as incurred. In instances where we enter into agreements with third parties to provide research and development services to us, costs are expensed as services are performed. Amounts due under such arrangements may be either fixed fee or fee for service, and may include upfront payments, monthly payments, and payments upon the completion of milestones or receipt of deliverables.
Our cost accruals for clinical trials and other research and development activities are based on estimates of the services received and efforts expended pursuant to contracts with numerous clinical trial centers and contract research organizations. In the normal course of business we contract with third parties to perform various research and development activities in the on-going development of our product candidates, including without limitation, third party clinical trial centers and contract research organizations that perform and administer our clinical trials on our behalf. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Payments under these agreements depend on factors such as the achievement of certain events, the successful enrollment of patients, and the completion of portions of the clinical trial or similar conditions. The objective of our accrual policy is to match the recording of expenses in our financial statements to the actual services received and efforts expended. As such, expense accruals related to clinical trials and other research and development activities are recognized based on our estimate of the degree of completion of the event or events specified in the specific agreement.
Our estimates are dependent upon the time lines and accuracy of data provided by third parties regarding the status and cost of studies, and may not match the actual services performed by the organizations. This could result in adjustment to our research and development expense in future periods. To date, we have had no significant adjustments.
Leases
At the inception of a lease, we evaluate the lease agreement to determine whether the lease is an operating or a capital lease using the criteria in ASC 840, Leases. For operating leases, we recognize rent expense on a straight-line basis over the non-cancellable lease term and record the difference between cash rent payments and the recognition of rent expense as a deferred liability. Where lease agreements contain rent escalation clauses, rent abatements and/or concessions, such as rent holidays and tenant improvement allowances, we apply them in the determination of straight-line rent expense over the lease term. We currently have no capital leases. Certain lease agreements also require us to make additional payments under the lease term for taxes, insurance, and other operating expenses incurred during the lease period, which are expensed as incurred.
Income Taxes
We establish reserves for uncertain income tax positions in accordance with ASC 740-10-25, Accounting for Uncertainty in Income Taxes, based on the technical support for the position, our past audit experiences with similar situations, and potential interest and penalties related to the matters. Our recorded reserves represent our best estimate of the amount, if any, that we may ultimately be required to pay to settle such matters. The resolution of our uncertain income tax positions is dependent on uncontrollable factors such as law changes, new case law, and the willingness of the income tax authorities to settle, including the timing thereof and other factors. Although we do not anticipate significant changes to our uncertain income tax positions in the next 12 months, items outside of our control could cause our uncertain income tax positions to change in the future, which would be recorded in our consolidated statements of operations. Interest and/or penalties related to income tax matters are recognized as a component of income tax expense as incurred.
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We maintained a full valuation allowance on our net deferred tax assets as of December 31, 2011. The valuation allowance was determined in accordance with the ASC 740-10, which requires an assessment of both positive and negative evidence when determining whether it is more likely than not that deferred tax assets are recoverable; such assessment is required on a jurisdiction by jurisdiction basis. Cumulative historic losses represented sufficient negative evidence under ASC 740-10 and accordingly, a full valuation allowance was recorded against U.S. deferred tax assets. We intend to maintain a full valuation allowance on the U.S. deferred tax assets until sufficient positive evidence exists to support reversal of the valuation allowance.
Basis of Presentation
The consolidated financial statements incorporate the accounts of Medivation, Inc. and its wholly-owned subsidiaries. All significant inter-company transactions and balances have been eliminated in consolidation. We operate in one business segment.
All tabular disclosures of dollar amounts are presented in thousands. All share and per share amounts are presented at their actual amounts. Percentages and amounts presented herein may not calculate or sum precisely due to rounding.
Recent Accounting Pronouncements
Information regarding recent accounting pronouncements applicable to us is included in the notes to our audited consolidated financial statement included elsewhere in this Annual Report.
Results of Operations
Collaboration Revenue
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Collaboration revenue from Astellas |
$ | 24,374 | $ | 23,492 | $ | 3,893 | ||||||
Collaboration revenue from Pfizer |
36,015 | 39,016 | 65,361 | |||||||||
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|
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Total |
$ | 60,389 | $ | 62,508 | $ | 69,254 | ||||||
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|
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Percentage change |
(3 | %) | (10 | %) |
The decrease in collaboration revenue for the year ended December 31, 2011 as compared to the prior year was due to a change in estimate of the remaining performance period under our former collaboration agreement with Pfizer, which is discussed below. Collaboration revenue for the year ended December 31, 2011 includes the incremental amortization resulting from $3.0 million and $10.0 million of development milestone payments received from our collaboration partner, Astellas, during the second quarter of 2011 and the fourth quarter of 2010, respectively, which have been deferred on our consolidated balance sheet and are being amortized on a straight-line basis over the estimated performance period with Astellas.
The $6.7 million decrease in collaboration revenue for the year ended December 31, 2010 as compared to the prior year was driven by lower collaboration revenues of $26.3 million from our former collaboration agreement with Pfizer due to the extension of our estimated performance period from the second quarter of 2012 to the fourth quarter of 2013, which is discussed below. This was partially offset by an increase of $19.6 million in collaboration revenue from the Astellas Collaboration Agreement, which was in effect for only one quarter in 2009.
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To date, we have received $123.0 million and $225.0 million of up-front and development milestone payments under the Astellas Collaboration Agreement and the former collaboration agreement with Pfizer, respectively. At December 31, 2011, deferred revenue balances with respect to these collaboration agreements were $71.2 million and $72.0 million, respectively. We amortize deferred revenue on a straight-line basis over the estimated performance period of our deliverables under the applicable collaboration agreement.
At December 31, 2011, management estimated that our performance periods under the Astellas Collaboration Agreement and the former collaboration agreement with Pfizer will be completed in the fourth quarter of 2014 and 2013, respectively. During the year ended December 31, 2010, we extended the estimated completion date of our performance period under the former collaboration agreement with Pfizer from the second quarter of 2012 to the fourth quarter of 2013, based on the failure of the CONNECTION trial and the resulting longer period required to complete the clinical trials evaluating dimebons potential safety and efficacy as a treatment for mild-to-moderate Alzheimers disease. The cumulative effect of these changes, which we applied on a prospective basis, was to extend the performance period by seven quarters and correspondingly reduce collaboration revenue related to the former collaboration agreement with Pfizer by $7.3 million per quarter over the remaining estimated performance period.
In January 2012, Pfizer exercised its right to terminate the collaboration agreement as discussed in the section titled Managements Discussion and Analysis of Financial Condition and Results of OperationsSubsequent EventsTermination of Pfizer Collaboration Agreement and Dimebon Program. During the ensuing 180 days, we and Pfizer will work together to wind down our respective remaining collaboration activities. We estimate that we and Pfizer will complete our respective collaboration wind down activities in the first half of 2012. Thus, during the first quarter of 2012, we revised our estimate of the remaining performance period under our former collaboration agreement with Pfizer. We expect the performance period to conclude in the first half of 2012. The remaining deferred revenue balance relating to the former collaboration agreement with Pfizer, which totaled $72.0 million at December 31, 2011, will be recognized as revenue over the remaining performance period.
Future changes in estimates of the performance periods under our collaboration agreements could significantly impact the timing of future revenue recognized under the applicable collaboration agreement.
Research and Development Expense
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Research and development expense |
$ | 73,432 | $ | 72,228 | $ | 87,728 | ||||||
Percentage change |
2 | % | (18 | %) |
Research and development, or R&D, expenses increased by $1.2 million, or 2%, to $73.4 million in the year ended December 31, 2011 from $72.2 million in the year ended December 31, 2010. The increase was due primarily to a $4.5 million increase in payroll-related expenses associated with increased headcount and higher bonus expense, a $3.9 million increase in consulting and professional service expenses associated with increased workload on our AFFIRM and PREVAIL trials and $2.0 million in preclinical expenses associated with new programs. These items were partially offset by lower clinical expenses of $7.6 million resulting primarily from reduced dimebon development activities.
R&D expenses decreased by $15.5 million, or 18%, in the year ended December 31, 2010 as compared to the prior year. This decrease was due primarily to a $10.0 million decrease in up-front and development milestone sharing expense to The Regents of the University of California, or UCLA, pursuant to the terms of our MDV3100 license agreement and a $5.2 million decrease in payroll costs resulting from favorable changes in employee-related cost-sharing payments with our collaboration partner Astellas and former collaboration partner Pfizer.
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R&D expenses represented 71%, 76% and 75% of total operating expenses for the years ended December 31, 2011, 2010 and 2009, respectively.
We recorded development cost-sharing payments from Astellas and Pfizer, and corresponding reductions in research and development expense, as follows:
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Development cost-sharing payments from Astellas |
$ | 44,285 | $ | 34,125 | $ | 2,784 | ||||||
Development cost-sharing payments from Pfizer |
12,365 | 29,139 | 20,435 | |||||||||
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Total |
$ | 56,650 | $ | 63,264 | $ | 23,219 | ||||||
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To date, we have been engaged in two major research and development programs: the development of MDV3100 for the treatment of advanced prostate cancer and the development of dimebon for the treatment of Alzheimers disease and Huntington disease. Other research and development programs consist of earlier stage programs. Research and development costs are identified as either directly allocable to one of our research and development programs or as an indirect cost, with only direct costs being tracked by specific program. Direct costs consist primarily of clinical and preclinical study costs, cost of supplying drug substance and drug product for use in clinical and preclinical studies, personnel costs (including both cash costs and non-cash stock-based compensation costs), contract research organization fees, and other contracted services pertaining to specific clinical and preclinical studies. Indirect costs consist of corporate overhead costs and other administrative and support costs. The following table summarizes the direct costs attributable to each program and the total indirect costs for each respective period.
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Direct costs: |
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MDV3100 |
$ | 40,545 | $ | 23,454 | $ | 27,046 | ||||||
Dimebon |
11,749 | 35,327 | 47,148 | |||||||||
Other |
14,088 | 9,258 | 9,461 | |||||||||
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Total direct costs |
66,382 | 68,039 | 83,655 | |||||||||
Indirect costs |
7,050 | 4,189 | 4,073 | |||||||||
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Total |
$ | 73,432 | $ | 72,228 | $ | 87,728 | ||||||
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Our projects or intended projects may be subject to change from time to time as we evaluate our research and development priorities and available resources.
Based on the negative results in the Phase 3 CONNECTION, HORIZON and CONCERT trials, we and Pfizer have discontinued development of dimebon for all indications in 2012. In January 2012, Pfizer exercised its right to terminate the collaboration agreement as discussed in the section titled, Managements Discussion and Analysis of Financial Condition and Results of OperationsSubsequent EventsTermination of Pfizer Collaboration Agreement and Dimebon Program.
In order to obtain the necessary regulatory approvals, we will need to establish to the satisfaction of the applicable regulatory authorities in the United States, Europe and other relevant countries that the applicable product candidate is both safe and effective for each of its intended indications. The process of conducting the preclinical and clinical testing required to establish safety and efficacy and obtain regulatory approvals is expensive, uncertain and takes many years. We are not able to reasonably estimate the time or cost required to obtain such regulatory approvals, and failure to receive the necessary regulatory approvals would prevent us from commercializing the product candidates affected. The length of time required for clinical development of a
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particular product candidate and our development costs for that product candidate may be impacted by the scope and timing of enrollment in clinical trials for the product candidate, unanticipated additional clinical trials that may be required, future decisions to develop a product candidate for subsequent indications, and whether in the future we decide to pursue development of the product candidate with a corporate partner or independently. For example, MDV3100 may have the potential to be approved for multiple indications, and we do not yet know how many of those indications we and our partner, Astellas, will pursue. The decision to pursue regulatory approval for subsequent indications will depend on several variables outside of our control, including the strength of the data generated in our prior and ongoing clinical and non-clinical studies and the willingness of our corporate partner to jointly fund such additional work. Furthermore, the scope and number of clinical studies required to obtain regulatory approval for each pursued indication is subject to the input of the applicable regulatory authorities; we have not yet sought such input for all potential indications that we and our collaboration partner may elect to pursue, and even after having given such input applicable regulatory authorities may subsequently require additional clinical studies prior to granting regulatory approval based on new data generated by us or other companies, or for other reasons outside of our control. Moreover, we or our current or potential future collaboration partners may decide to discontinue development of any development project at any time for regulatory, commercial, scientific or other reasons. To date, we have not commercialized any of our product candidates and in fact may never do so.
Selling, General and Administrative Expense
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Selling, general and administrative expense |
$ | 29,887 | $ | 23,005 | $ | 28,983 | ||||||
Percentage change |
30 | % | (21 | %) |
Selling, general and administrative, or SG&A, expense increased by $6.9 million, or 30%, to $29.9 million in the year ended December 31, 2011 from $23.0 million in the year ended December 31, 2010. This increase was due primarily to a $3.6 million increase in payroll-related expenses associated with increased headcount and higher bonus expense, a $1.7 million increase in legal fees primarily related to a litigation matter we initiated in the second quarter of 2011 against the licensor of our MDV3100 technology and the defense of the securities class action lawsuit following the negative results in our CONNECTION trial, for which we are subject to a $350,000 retention. The increase in SG&A expense was further impacted by an increase in sales and marketing expenses of $0.9 million as a result of increased market research and public relations expense due to the positive results of our Phase 3 AFFIRM trial discussed elsewhere in this Annual Report and recruitment expenses of $0.3 million as a result of increased headcount in 2011. These items were partially offset by restructuring costs and a lease termination fee in response to the negative results of our Phase 3 CONNECTION trial discussed elsewhere in this Annual Report.
SG&A expense decreased by $6.0 million, or 21%, in the year ended December 31, 2010 as compared to the prior year. This decrease was due primarily to decreases of $2.6 million in consulting and professional services fees, $2.5 million in payroll and other costs associated with lower headcount related to our SG&A activities and $0.9 million in sales and marketing expenses. These expense reductions were largely pursuant to the restructuring that we implemented in March 2010 in response to the negative results of our CONNECTION trial.
SG&A expenses represented 29%, 24% and 25% of total operating expenses in the years ended December 31, 2011, 2010 and 2009, respectively. We expect SG&A expenses to continue to increase as a percentage of our overall operating expenses as we hire additional staff and incur additional expenses in preparation for a potential commercial launch of MDV3100 in post-chemotherapy advanced prostate cancer.
46
We recorded commercialization cost-sharing payments (to) from Astellas and Pfizer, and corresponding (increases) reductions in SG&A expenses, as follows:
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Commercialization cost-sharing payments (to) from Astellas |
$ | (472 | ) | $ | 520 | $ | 74 | |||||
Commercialization cost-sharing payments (to) from Pfizer |
32 | (1,084 | ) | (720 | ) | |||||||
|
|
|
|
|
|
|||||||
Total |
$ | (440 | ) | $ | (564 | ) | $ | (646 | ) | |||
|
|
|
|
|
|
Other (Expense) Income, net
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Other (expense) income, net |
$ | (242 | ) | $ | 260 | $ | 976 |
Other (expense) income, net, consists of interest income on our cash and short-term investment balances as well as the impact of changes in foreign exchange rates on our foreign exchange denominated payables. The impact of foreign exchange rates on our results of operations fluctuates period over period based upon our foreign currency exposures resulting from changes in applicable exchange rates associated with our foreign denominated payables.
Interest income decreased $0.2 million to $0.1 million for the year ended December 31, 2011 as compared to $0.3 million for the year ended December 31, 2010. The decrease was due to lower investment yields and average investment balances during 2011. We recognized foreign currency losses of $0.3 million during the year ended December 31, 2011 as compared to foreign currency losses of $0.1 million for the year ended December 31, 2010.
Interest income decreased $0.8 million to $0.3 million for the year ended December 31, 2010 as compared to $1.1 million for the year ended December 31, 2009. The decrease was due to lower investment yields and average investment balances in 2010. We recognized foreign currency losses of $0.1 million during the year ended December 31, 2010 as compared to foreign currency losses of $0.2 million for the year ended December 31, 2009.
Income Tax (Benefit) Expense
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Income tax (benefit) expense |
$ | (4,331 | ) | $ | 1,572 | $ | 8,272 | |||||
Effective tax rate |
10.0 | % | (4.8 | %) | (17.9 | %) |
The income tax benefit for the year ended December 31, 2011 was $4.3 million and represents an effective tax rate of 10.0%. The income tax benefit mainly consists of a benefit due to the ability to carry back the current year Federal net operating loss, or NOL, to the prior two tax years. The difference in the effective tax rate for 2011 as compared to 2010 is primarily attributable to the benefit in 2011 due to the ability to carry back the current year Federal NOL to the prior two tax years.
The income tax expense for 2010 was approximately $1.6 million, which mainly consisted of Federal and state income tax and represents an effective tax rate of (4.8%). We incurred income tax liability for 2010 despite reporting a net loss in our consolidated financial statements primarily because we recognized for tax purposes in 2010 substantially all of the $110.0 million up-front payment and all of the $10.0 million development milestone payment previously received from Astellas. Due to the suspension of California net operating loss, or NOL,
47
utilization for 2010, we were not able to utilize NOL carryforwards to offset state taxable income. The reduction in the effective tax rate for 2010 as compared to 2009 is primarily attributable to a California state income tax refund of $5.3 million recognized in 2010.
The income tax expense for 2009 was approximately $8.3 million, which mainly consisted of federal and state income tax and represents an effective tax rate of 17.9%. We incurred income tax liability for 2009 despite reporting a net loss for financial statement purposes primarily because we recognized for tax purposes in 2009 substantially all of the $225.0 million up-front payment previously received from our former collaboration partner Pfizer. Due to the suspension of California NOL utilization for 2009, we were not able to utilize NOL carryforwards to offset state taxable income.
A reconciliation of the Federal statutory income tax rate of 35% to our effective tax rate for each year presented is included in Note 9 , Income Taxes, to our consolidated financial statements included elsewhere in this Annual Report.
Liquidity and Capital Resources
Sources of Liquidity
We have incurred cumulative net losses of $250.3 million through December 31, 2011, and we expect to incur substantial additional losses for the foreseeable future as we pursue regulatory approval for, and, if approved, commercial launch of, MDV3100 and continue to finance clinical and preclinical studies of MDV3100 and potential future product candidates and our corporate overhead costs. We have not generated any revenue from product sales to date, and we may never generate any revenue from product sales. Our operations to date have been funded primarily through private and public offerings of our common stock and from the up-front, development milestone and cost-sharing payments from our collaboration partner Astellas and from our former collaboration partner, Pfizer.
As of December 31, 2011, we had cash, cash equivalents and short-term investments totaling $145.1 million available to fund our operations. Based upon our current expectations, we believe our capital resources at December 31, 2011 will be sufficient to fund our currently planned operations for the next 12 months. This estimate is based on a number of assumptions that may prove to be wrong and we could exhaust our available cash, cash equivalents and short-term investment earlier than presently anticipated. We may be required or choose to seek additional capital within the next 12 months to expand our clinical development activities for MDV3100 based on the positive results of our Phase 3 AFFIRM trial in post-chemotherapy advanced prostate cancer patients, to fund costs of planning for and executing a commercial launch of MDV3100, should it receive marketing approval, if we face challenges or delays in connection with our clinical trials or the potential approval and commercialization of MDV3100, or to maintain minimum cash balances that we deem reasonable and prudent. In addition, we intend to evaluate the capital markets from time to time to determine whether to raise additional capital in the form of equity, convertible debt or otherwise, depending on market conditions relative to our need for funds at such time, and we may seek to raise additional capital within the next 12 months should we conclude that such capital is available on terms that we consider to be in the best interests of our company and our stockholders.
Our current view of the worldwide capital markets is that they are extremely volatile with limited accessibility, and many biotechnology companies have had limited or no success in obtaining funding in this environment. Continuation of this challenging market climate may significantly limit our ability to raise funds, and there can be no assurance we will be able to raise additional funds on acceptable terms or at all. If we are unable to raise additional funds when needed, we could be required to delay, scale back or eliminate some or all of our development programs and other operations. We may seek to raise additional funds through public or private financing or other arrangements. Any additional equity financing would be dilutive to stockholders, and debt financing, if available, may involve restrictive covenants. Our failure to raise capital when needed may harm our business and operating results.
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Our future capital requirements will depend on many factors, many of which are wholly or partially outside of our control. Such factors include, without limitation:
| potential launch costs of MDV3100, should that agent receive marketing approval for post-chemotherapy patients; |
| the timing and magnitude of any potential sales of MDV3100, should that agent receive marketing approval for post-chemotherapy patients; |
| whether any changes are made to the scope of our ongoing clinical development activities; |
| the scope and results of our and our collaboration partners preclinical and clinical trials; |
| whether we experience delays in our preclinical and clinical development programs, including potential delays in recruiting, or inability to recruit, patients into our ongoing PREVAIL trial of MDV3100 in pre-chemotherapy advanced prostate cancer as a result of the availability of Zytiga (abiraterone acetate), which was approved by the FDA in April 2011 for post-chemotherapy patients, or other investigational and approved prostate cancer therapies, including MDV3100 itself should that agent be approved to treat post-chemotherapy patients, or slower than anticipated product development; |
| whether opportunities to acquire additional product candidates arise and the timing and costs of acquiring and developing those product candidates; |
| whether we are able to enter into additional third-party collaborative partnerships to develop and/or commercialize potential future product candidates on terms, including development cost share terms, that are acceptable to us; |
| the timing and requirements of, and the costs involved in, conducting studies required to obtain regulatory approvals for MDV3100 or potential future product candidates from the FDA and comparable foreign regulatory agencies; |
| the availability of third parties to perform the key development tasks for MDV3100 and potential future product candidates, including conducting preclinical and clinical studies and manufacturing our product candidates to be tested in those studies, and the associated costs of those services; |
| expenses associated with the pending purported securities class action lawsuits, as well as any other litigation; and |
| the costs involved in preparing, filing, prosecuting, maintaining, defending the validity of and enforcing patent claims and other costs related to patent rights and other intellectual property rights, including litigation costs and the results of such litigation. |
Astellas Collaboration Agreement
We entered into a collaboration agreement with Astellas in October 2009. Under the Astellas Collaboration Agreement, we and Astellas agreed to collaborate on the development of MDV3100 for the United States market, including associated regulatory filings with the FDA. In addition, if approved by the FDA, following such approval and the launch of MDV3100 in the United States, we and Astellas will co-promote MDV3100 in the United States. Astellas is responsible for development of, and seeking regulatory approval for, and commercialization of MDV3100 outside the United States. Astellas will be responsible for commercial manufacture of MDV3100 on a global basis. Both we and Astellas have agreed not to commercialize certain other products having a similar mechanism of action as MDV3100 for the treatment of specified indications for a specified time period, subject to certain exceptions.
We and Astellas share equally the costs of developing and commercializing MDV3100 for the United States market (subject to the exceptions noted below), and we and Astellas will share equally profits (or losses) resulting from the commercialization of MDV3100 in the United States. Costs of clinical trials supporting development in both the United States and in either Europe or Japan are borne two-thirds by Astellas and
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one-third by us. Both we and Astellas will be responsible for all costs incurred in fielding and supporting our respective MDV3100 sales forces, and each of us will be entitled to receive a fee for each detail made by our respective sales forces. Outside the United States, Astellas will bear all development and commercialization costs and will pay us tiered, double-digit royalties on the aggregate net sales of MDV3100.
The Astellas Collaboration Agreement establishes several joint committees consisting of an equal number of representatives from both parties that operate by consensus to oversee the collaboration. In the event that a joint committee is unable to reach consensus on a particular issue, then, depending on the issue, a dispute may be decided at the joint committee level by the party with the final decision on the issue or escalated to senior management of the parties. If a dispute is escalated to senior management and no consensus is reached, then the dispute may be decided by the party to whom the contract grants final decision on such issue. Other issues can only be decided by consensus of the parties, and unless and until the parties representatives reach agreement on such issue, no decision on such issue will be made, and the status quo will be maintained.
Under the Astellas Collaboration Agreement, Astellas paid us a non-refundable, up-front cash payment of $110.0 million in the fourth quarter of 2009. We are also eligible to receive up to $335.0 million in development milestone payments, plus up to an additional $320.0 million in commercial milestone payments. As of December 31, 2011, we had received an aggregate of $13.0 million in development milestone payments under the Astellas Collaboration Agreement. Should the FDA or European Medicines Agency accept for filing an NDA or a MAA, respectively, seeking approval of MDV3100 in post-chemotherapy patients based on the positive results from our AFFIRM trial, we would be entitled to a $10.0 million and a $5.0 million milestone payment, respectively, under the Astellas Collaboration Agreement. In addition, should the NDA or MAA be approved by the FDA or European regulators, respectively, we would be entitled to a $30.0 million and a $15.0 million milestone payment, respectively, from Astellas. We are required to share 10% of the up-front and development milestone payments received under the Astellas Collaboration Agreement with UCLA pursuant to the terms of our MDV3100 license agreement, which is discussed elsewhere in this Annual Report.
Each of Medivation and Astellas is permitted to terminate the Astellas Collaboration Agreement for an uncured material breach by the other party or for the insolvency of the other party. Astellas has a right to terminate the Astellas Collaboration Agreement unilaterally by advance written notice to us, but, except in certain specific circumstances, generally cannot exercise that termination right until the first anniversary of MDV3100s first commercial sale. Following any termination of the Astellas Collaboration Agreement in its entirety, all rights to develop and commercialize MDV3100 will revert to us, and Astellas will grant a license to us to enable us to continue such development and commercialization. In addition, except in the case of a termination by Astellas for our uncured material breach, Astellas will supply MDV3100 to us during a specified transition period.
Former Collaboration Agreement with Pfizer
We entered into a collaboration agreement with Pfizer in October 2008. Under the agreement, we and Pfizer agreed to collaborate on the development and commercialization of dimebon for Alzheimers disease and Huntington disease for the United States market, including associated regulatory filings with the FDA. Pfizer paid us a non-refundable up-front cash payment of $225.0 million in the fourth quarter of 2008 pursuant to the terms of the agreement. Under the terms of the former collaboration agreement, we and Pfizer shared the costs and expenses of developing and commercializing dimebon for the United States market on a 60%/40% basis, with Pfizer assuming the larger share. Based on the negative results in the Phase 3 CONNECTION, HORIZON, and CONCERT trials, we and Pfizer have discontinued the development of dimebon for all indications in 2012. In January 2012, Pfizer exercised its right to terminate the collaboration agreement as discussed in Managements Discussion and Analysis of Financial Condition and Results of OperationsSubsequent EventsTermination of Pfizer Collaboration Agreement and Dimebon Program.
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Cash Flow Analysis
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Net cash (used in) provided by: |
||||||||||||
Operating activities |
$ | (75,961 | ) | $ | (75,064 | ) | $ | (7,585 | ) | |||
Investing activities |
19,687 | 122,415 | (72,568 | ) | ||||||||
Financing activities |
18,693 | 2,903 | 66,162 | |||||||||
|
|
|
|
|
|
|||||||
Net change in cash and cash equivalents |
$ | (37,581 | ) | $ | 50,254 | $ | (13,991 | ) | ||||
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|
|
|
|
|
Operating Activities
Net cash used in operating activities totaled $76.0 million in 2011, which consisted of our net loss of $38.8 million and non-cash items of $46.1 million, partially offset by changes in operating assets and liabilities of $9.0 million. Non-cash items consisted primarily of the non-cash amortization of deferred revenue of $60.4 million, partially offset by non-cash stock-based compensation expense of $13.9 million. The increase in cash flows from changes in operating assets and liabilities was primarily driven by a $8.6 million decrease in receivables from our collaboration partner Astellas and our former collaboration partner Pfizer, an increase of $2.4 million in accounts payable arising in the ordinary course of business, an increase of $2.5 million in accrued expenses primarily driven by higher clinical and preclinical accruals and an increase in deferred revenue of $3.0 million related to a development milestone payment received from Astellas. These items were partially offset by a decrease in other current liabilities of $4.9 million as a result of a federal income tax payment of $4.5 million during 2011.
Net cash used in operating activities totaled $75.1 million in 2010, which consisted of our net loss of $34.1 million and non-cash items of $48.8 million, partially offset by changes in operating assets and liabilities of $7.8 million. Non-cash items consisted primarily of the non-cash amortization of deferred revenue of $62.5 million, partially offset by non-cash stock-based compensation expense of $13.5 million. The increase in cash flows from changes in operating assets and liabilities was primarily driven by a $10.0 million development milestone payment we received from Astellas, an increase in accounts payable and accrued expenses of $7.7 million arising in the ordinary course of business, and an increase in other current liabilities of $4.4 million, partially offset by increased receivables of $14.7 million from our collaboration partner Astellas and our former collaboration partner Pfizer.
Net cash used in operating activities totaled $7.6 million in 2009, which consisted of our net loss of $54.8 million and non-cash items of $59.3 million, partially offset by changes in operating assets and liabilities of $106.5 million. Non-cash items consisted primarily of the non-cash amortization of deferred revenue of $69.3 million, partially offset by non-cash stock-based compensation expense of $10.8 million. The increase in cash flows from changes in operating assets and liabilities was primarily driven by the non-refundable upfront payment of $110.0 million we received from Astellas and increased accounts payable and accrued expenses of $4.0 million arising in the ordinary course of business, partially offset by increased prepaid expenses of $5.5 million and increased receivables of $3.0 million from our collaboration partner Astellas and former collaboration partner Pfizer.
Investing Activities
Net cash provided by investing activities totaled $19.7 million in 2011, consisting primarily of net maturities of short-term investments of $25.1 million partially offset by an increase of $5.1 million in letters of credit collateralized by restricted cash to secure an operating lease for our future corporate headquarters.
Net cash provided by investing activities totaled $122.4 million in 2010, consisting primarily of net maturities of short-term investments.
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Net cash used in investing activities totaled $72.6 million in 2009, consisting primarily of net purchases of short-term investments.
Financing Activities
Net cash provided by financing activities totaled $18.7 million in the year ended December 31, 2011, consisting of $15.7 million in proceeds from the exercise of stock options and $3.0 million in net proceeds received in settlement of a short swing profit liability incurred by an unaffiliated stockholder.
Net cash provided by financing activities totaled $2.9 million in 2010, consisting primarily of $2.6 million in proceeds from the exercise of stock options and warrants.
Net cash provided by financing activities totaled $66.2 million in 2009, consisting primarily of net proceeds of approximately $62.1 million from the sale of our common stock in a registered offering and $3.4 million in proceeds from the exercise of stock options and warrants.
Commitments and Contingencies
The future minimum rentals under our non-cancelable operating leases at December 31, 2011 were as follows:
Payment due by Period | ||||||||||||||||||||
Total | Less than 1 Year |
1-3 Years | 4-5 Years | > 5 Years | ||||||||||||||||
Operating lease obligations |
$ | 28,802 | $ | 3,599 | $ | 13,997 | $ | 6,651 | $ | 4,555 |
Additional information regarding our operating leases is included in Note 11, Commitments and Contingencies, to our consolidated financial statements included elsewhere in this Annual Report.
In February 2012, we entered into a lease agreement for 15,336 square feet of office space located in Oakbrook Terrace, Illinois, which is intended to serve as our commercial headquarters following construction and build-out. The term of the lease is seven years and seven months, with an anticipated commencement date of May 2012. We selected this location for our commercial headquarters based on its proximity to our collaboration partner, Astellas. The annual non-cancelable rent payments are approximately $0.3 million per year. In connection with the execution of the lease, we delivered to the lessor a letter of credit collateralized by restricted cash totaling $0.8 million. The future minimum lease payments under this lease are not included in the table above.
In addition to the contractual obligations disclosed in the table above, we have other potential obligations for which the timing and the extent of future payments are not known. We have described these potential obligations in the following paragraphs.
At December 31, 2011, $3.9 million of unrecognized tax benefits have been recorded as liabilities for uncertain income tax positions. The ultimate resolution of our uncertain income tax positions is dependent on uncontrollable factors such as law changes, new case law, and the willingness of the income tax authorities to settle, including the timing thereof, and other factors. Although we do not anticipate significant changes to our uncertain income tax positions in the next twelve months, items outside of our control could cause our uncertain income tax positions to change in the future. Such amounts have been included on our consolidated balance sheet at December 31, 2011, but have not been included in the table above.
We have a license agreement with UCLA under which we are required to pay UCLA an annual maintenance fee, up to $5.5 million in aggregate milestone payments upon the achievement of certain development and regulatory milestone events, and 10% of any up-front and development milestone payments we receive from
52
sublicensees. We are also required to pay UCLA a single-digit royalty on sales of products falling within the scope of the patent rights licensed from UCLA. Should we receive marketing approval of MDV3100 in either the U.S. or Europe, we would be required to pay UCLA a single, one-time milestone payment of $2.0 million. Because the achievement of the development and regulatory milestones and the contingent royalty payments is neither probable nor reasonably estimable, such amounts have not been recorded on our consolidated balance sheet at December 31, 2011 and have not been included in the table above.
Off-Balance Sheet Arrangements
We have no material off-balance sheet arrangements as defined in Regulation S-K 303(a)(4)(ii).
Item 7A. | Quantitative and Qualitative Disclosures About Market Risk. |
Our exposure to market risk for changes in interest rates relates to our cash equivalents on deposit in highly liquid money market accounts and short-term investments in highly liquid U.S. Treasury securities. The primary objective of our cash investment activities is to preserve principal. We do not use derivative financial instruments in our investment portfolio. Our cash and investments policy emphasizes liquidity and preservation of principal over other portfolio considerations. Our investment portfolio is subject to interest rate risk and will fall in value if market interest rates rise. There were no material changes to our market risk from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2010.
Interest Rate Risk
Our cash equivalents and short-term investments are exposed to the impact of interest rate changes and our interest income fluctuates as interest rates change. Due to the short-term nature of our investments in money market funds and U.S. Treasury securities, the carrying value of our cash equivalents and short-term investments approximate their fair value at December 31, 2011. Due to the short-term, highly liquid nature of our investments, we do not believe that we are subject to any material market risk exposure related to interest rates.
Foreign Currency Exchange Risk
We do not have any material exposure to foreign currency rate fluctuations as we operate primarily in the U.S. Although we conduct some research and development work with vendors outside the U.S., most of our transactions are denominated in U.S. dollars. However, certain of our ex-U.S. clinical development activities are pursuant to contracts denominated in foreign currencies. For the year ended December 31, 2011, we recorded $0.3 million in foreign currency exchange losses.
Item 8. | Financial Statements and Supplementary Data. |
All information required by this item is included in Item 15 of Part IV of this Annual Report on Form 10-K and is incorporated into this item by reference.
Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. |
None.
Item 9A. | Controls and Procedures. |
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures, as such term is defined in Rule 13a-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods
53
specified in the SEC rules and forms and that such information is communicated to our management, including our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable, but not absolute, assurance that the objectives of the disclosure controls and procedures are met. Our disclosure controls and procedures have been designed to meet the reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
As required by Rule 13a-15(b) or Rule 15d-15(b) of the Exchange Act, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), of the effectiveness of the design and operation of our disclosure controls and procedures as of December 31, 2011. Based on the foregoing, our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer) concluded that our disclosure controls and procedures were effective as of December 31, 2011 at the reasonable assurance level.
Managements 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 Rule 13a-15(f). Management, with the participation of our principal executive officer and principal financial officer, has conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework set forth in Internal ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation under the framework set forth in Internal ControlIntegrated Framework, our management concluded that our internal control over financial reporting was effective as of December 31, 2011.
The effectiveness of our internal control over financial reporting as of December 31, 2011 has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which appears elsewhere herein.
Changes in Internal Control Over Financial Reporting
There were no changes in internal control over financial reporting during the quarter ended December 31, 2011 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. | Other Information. |
None.
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PART III
The information required by Part III is omitted from this Annual Report on Form 10-K since we intend to file our definitive Proxy Statement for our 2012 Annual Meeting of Stockholders, pursuant to Regulation 14A of the Exchange Act, not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, and certain information to be included in the Proxy Statement is incorporated herein by reference.
Item 10. | Directors, Executive Officers and Corporate Governance. |
Information required by this item regarding directors and director nominees, executive officers, the board of directors and its committees, and certain corporate governance matters is incorporated by reference to the information set forth under the captions Election of Directors, Information Regarding the Board of Directors and Corporate Governance and Executive Officers in our Proxy Statement for the 2012 Annual Meeting of Stockholders. Information required by this item regarding compliance with Section 16(a) of the Exchange Act is incorporated by reference to the information set forth under the caption Section 16(a) Beneficial Ownership Reporting Compliance in our Proxy Statement for the 2012 Annual Meeting of Stockholders.
We have adopted a written code of business conduct and ethics that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons serving similar functions. The code of business conduct and ethics is available on our corporate website at www.medivation.com. If we make any substantive amendments to our code of business conduct and ethics or grant to any of our directors or executive officers any waiver, including any implicit waiver, from a provision of our code of business conduct and ethics, we will disclose the nature of the waiver or amendment on our website or in a Current Report on Form 8-K.
Item 11. | Executive Compensation. |
Information required by this item regarding executive compensation is incorporated by reference to the information set forth under the captions Executive Compensation, Director Compensation and Information Regarding the Board of Directors and Corporate Governance in our Proxy Statement for the 2012 Annual Meeting of Stockholders.
Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. |
Information required by this item regarding security ownership of certain beneficial owners and management is incorporated by reference to the information set forth under the caption Security Ownership of Certain Beneficial Owners and Management in our Proxy Statement for the 2012 Annual Meeting of Stockholders. Information required by this item regarding securities authorized for issuance under our equity compensation plans is incorporated by reference to the information set forth under the caption Equity Compensation Plan Information in our Proxy Statement for the 2012 Annual Meeting of Stockholders.
Item 13. | Certain Relationships and Related Transactions, and Director Independence. |
Information required by this item regarding certain relationships and related transactions is incorporated by reference to the information set forth under the caption Transactions with Related Persons in our Proxy Statement for the 2012 Annual Meeting of Stockholders. Information required by this item regarding director independence is incorporated by reference to the information set forth under the caption Information Regarding the Board of Directors and Corporate Governance in our Proxy Statement for the 2012 Annual Meeting of Stockholders.
Item 14. | Principal Accounting Fees and Services. |
Information required by this item regarding principal accounting fees and services is incorporated by reference to the information set forth under the caption Ratification of Selection of Independent Registered Public Accounting Firm in our Proxy Statement for the 2012 Annual Meeting of Stockholders.
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PART IV
Item 15. | Exhibits, Financial Statement Schedules. |
(a) The following documents are filed as part of this Annual Report on Form 10-K:
1. Financial Statements. Our consolidated financial statements and the Report of Independent Registered Public Accounting Firm, are included herein on the pages indicated:
2. Financial Statement Schedules: None.
3. Exhibits:
|
Incorporated By Reference | |||||||||||||||||
Exhibit |
Exhibit Description |
Form |
File No. |
Exhibit | Filing Date |
Filed Herewith | ||||||||||||
3.1 | Amended and Restated Certificate of Incorporation. | 10-QSB | 000-20837 | 3.1(a) | 8/15/2005 | |||||||||||||
3.2 | Certificate of Amendment of Amended and Restated Certificate of Incorporation. | 10-QSB | 000-20837 | 3.1(b) | 8/15/2005 | |||||||||||||
3.3 | Certificate of Amendment to the Amended and Restated Certificate of Incorporation. | 10-QSB | 000-20837 | 3.1(c) | 8/15/2005 | |||||||||||||
3.4 | Certificate of Designations of the Series C Junior Participating Preferred Stock of Medivation, Inc. | 10-KSB | 001-32836 | 3.1(d) | 2/19/2008 | |||||||||||||
3.5 | Amended and Restated Bylaws of Medivation, Inc. | 10-K | 001-32836 | 3.2 | 3/16/2009 | |||||||||||||
4.1 | Common Stock Certificate. | SB-2/A | 333-03252 | 4.1 | 6/14/1996 | |||||||||||||
4.2 | Rights Agreement, dated as of December 4, 2006, between Medivation, Inc. and American Stock Transfer & Trust Company, as Rights Agent, which includes the form of Certificate of Designations of the Series C Junior Participating Preferred Stock of Medivation, Inc. as Exhibit A, the form of Right Certificate as Exhibit B and the Summary of Rights to Purchase Preferred Shares as Exhibit C. | 8-K | 001-32836 | 4.1 | 12/4/2006 |
56
|
Incorporated By Reference | |||||||||||||||||||
Exhibit |
Exhibit Description |
Form |
File No. |
Exhibit | Filing Date |
Filed Herewith |
||||||||||||||
10.1 | Warrant to purchase Common Stock of Medivation Neurology, Inc. assumed by Orion Acquisition Corp. II issued to Joseph J. Grano, Jr., dated as of June 8, 2004. | SB-2 | 333-122431 | 10.5(a) | 1/31/2005 | |||||||||||||||
10.2* | Warrant to purchase Common Stock of Medivation Neurology, Inc. assumed by Orion Acquisition Corp. II issued to David T. Hung, M.D., dated as of November 16, 2004. | SB-2 | 333-122431 | 10.6 | 1/31/2005 | |||||||||||||||
10.3* | Amended and Restated 2004 Equity Incentive Award Plan. | 10-KSB | 001-32836 | 10.4(a) | 2/19/2008 | |||||||||||||||
10.4* | Form of Stock Option Agreement under the 2004 Equity Incentive Award Plan. | 10-KSB | 000-20837 | 10.7(b) | 2/11/2005 | |||||||||||||||
10.5* | Form of Stock Option Agreement for Early Exercisable Options under the 2004 Equity Incentive Award Plan. | 10-KSB | 000-20837 | 10.7(c) | 2/11/2005 | |||||||||||||||
10.6** | Amended and Restated Collaboration Agreement, dated as of October 20, 2008, between Medivation, Inc. and Pfizer Inc. | 10-Q | 001-32836 | 10.8 | 11/10/2008 | |||||||||||||||
10.7* | Change of Control Severance Benefits Agreement, dated as of February 2, 2009, between Medivation, Inc. and David Hung, M.D. | 10-K | 001-32836 | 10.11 | 3/16/2009 | |||||||||||||||
10.8* | Form of Medivation, Inc. Change of Control Severance Benefits Agreement. | 10-K | 001-32836 | 10.13 | 3/16/2009 | |||||||||||||||
10.9** | Collaboration Agreement, dated as of October 26, 2009, by and between Medivation, Inc. and Astellas US LLC. | 10-K | 001-32836 | 10.15 | 3/15/2010 | |||||||||||||||
10.10** | Amendment No. 1 to Collaboration Agreement, dated January 1, 2010, by and among Medivation, Inc., Astellas Pharma Inc. and Astellas US LLC | 10-Q | 001-32836 | 10.1 | 8/9/2011 | |||||||||||||||
10.11** | Amendment No. 2 to Collaboration Agreement, dated May 13, 2011, by and among Medivation, Inc., Astellas Pharma Inc. and Astellas US LLC | 10-Q | 001-32836 | 10.2 | 8/9/2011 | |||||||||||||||
10.12 | Office Lease Agreement, dated as of November 2, 2009, by and between Medivation, Inc. and PPF OFF 345 Spear Street, LP. | 10-K | 001-32836 | 10.16 | 3/15/2010 | |||||||||||||||
10.13* | Compensation Information for Non-Employee Directors. | X |
57
|
Incorporated By Reference | |||||||||||||||||||
Exhibit |
Exhibit Description |
Form |
File No. |
Exhibit | Filing Date |
Filed Herewith |
||||||||||||||
10.14** | Exclusive License Agreement, dated as of August 12, 2005, as amended through October 21, 2009, by and between Medivation, Inc. and The Regents of the University of California. | 10-Q/A | 001-32836 | 10.18 | 8/20/2010 | |||||||||||||||
10.15 | Office Lease, dated April 18, 2007, by and between CREA Spear Street Terrace LLC and Medivation, Inc. | 10-K | 001-32836 | 10.16 | 3/16/2011 | |||||||||||||||
10.16 | Sublease, dated November 10, 2008, by and between MacFarlane Partners Investment Management, LLC and Medivation, Inc. | 10-K | 001-32836 | 10.17 | 3/16/2011 | |||||||||||||||
10.17 | First Amendment to Lease, dated September 16, 2009, by and between CREA Spear Street Terrace LLC and Medivation, Inc. | 10-K | 001-32836 | 10.18 | 3/16/2011 | |||||||||||||||
10.18 | Second Amendment to Lease, dated November 30, 2010, by and between CREA Spear Street Terrace LLC and Medivation, Inc. | 10-K | 001-32836 | 10.19 | 3/16/2011 | |||||||||||||||
10.19* | Bonuses for Fiscal Year 2010 and Base Salaries for Fiscal Year 2011 for Certain Executive Officers. | 10-K | 001-32836 | 10.20 | 3/16/2011 | |||||||||||||||
10.20* | Medivation, Inc. 2011 Bonus Plan Summary. | 10-K | 001-32836 | 10.21 | 3/16/2011 | |||||||||||||||
10.21* | Form of Restricted Stock Unit Grant Notice and Agreement under the 2004 Equity Incentive Award Plan. | 10-K | 001-32836 | 10.22 | 3/16/2011 | |||||||||||||||
10.22* | Separation Agreement, dated as of September 21, 2011, between Medivation, Inc. and Rohan Palekar. | 8-K | 001-32836 | 10.1 | 9/27/2011 | |||||||||||||||
10.23* | Bonuses for Fiscal Year 2011 and Base Salaries for Fiscal Year 2012 for Certain Executive Officers | 8-K | 001-32836 | 10.1 | 12/15/2011 | |||||||||||||||
10.24* | Medivation, Inc. 2012 Bonus Plan Summary | 8-K | 001-32836 | 10.2 | 12/15/2011 | |||||||||||||||
10.25* | Form of Indemnification Agreement for directors and officers | X | ||||||||||||||||||
10.26* | Offer Letter, dated August 31, 2011, by and between Medivation, Inc. and Cheryl Cohen. | X | ||||||||||||||||||
10.27 | Office Lease, dated as of December 28, 2011, by and between Knickerbocker Properties, Inc. XXXIII and Medivation, Inc. | X | ||||||||||||||||||
10.28* | Form of Stock Appreciation Right Grant Notice and Agreement under the 2004 Equity Incentive Award Plan | X |
58
|
Incorporated By Reference | |||||||||||||
Exhibit |
Exhibit Description |
Form |
File No. |
Exhibit | Filing Date |
Filed Herewith |
||||||||
10.29* | Form of Performance Share Award Grant Notice and Agreement under the 2004 Equity Incentive Award Plan | X | ||||||||||||
21.1 | Subsidiaries of Medivation, Inc. | X | ||||||||||||
23.1 | Consent of Independent Registered Public Accounting Firm. | X | ||||||||||||
24.1 | Power of Attorney (contained on signature page). | X | ||||||||||||
31.1 | Certification pursuant to Rule 13a-14(a)/15d-14(a). | X | ||||||||||||
31.2 | Certification pursuant to Rule 13a-14(a)/15d-14(a). | X | ||||||||||||
32.1 | Certifications of Chief Executive Officer and Chief Financial Officer. | X | ||||||||||||
101.INS# | XBRL Instance Document. | X | ||||||||||||
101.SCH# | XBRL Taxonomy Extension Schema Document. | X | ||||||||||||
101.CAL# | XBRL Taxonomy Extension Calculation Linkbase Document | X | ||||||||||||
101.DEF# | XBRL Taxonomy Extension Definition Linkbase Document | X | ||||||||||||
101.LAB# | XBRL Taxonomy Extension Labels Linkbase Document | X | ||||||||||||
101.PRE# | XBRL Taxonomy Extension Presentation Linkbase Document | X |
* | Indicates management contract or compensatory plan or arrangement. |
** | Confidential treatment has been granted with respect to certain portions of this exhibit. |
| The certifications attached as Exhibit 32.1 accompany this Annual Report on Form 10-K, are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Medivation, Inc., under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation language contained in such filing. |
# | Pursuant to applicable securities laws and regulations, the Registrant is deemed to have complied with the reporting obligation related to the submission of interactive data files in such exhibits and is not subject to liability under any anti-fraud provisions of the federal securities laws as long as the Registrant has made a good faith attempt to comply with the submission requirements and promptly amends the interactive data files after becoming aware that the interactive data files fails to comply with the submission requirements. These interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act, are deemed not filed for the purposes of section 18 of the Exchange Act and otherwise are not subject to liability under those sections. |
59
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.
MEDIVATION, INC. | ||
/S/ C. PATRICK MACHADO | ||
C. Patrick Machado Chief Business Officer and Chief Financial Officer (Duly Authorized and Principal Financial and Accounting Officer) |
Dated: February 29, 2012
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints David T. Hung, M.D. and C. Patrick Machado, and each of them, as his true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him and in his name, place, and stead, in any and all capacities, to sign any and all amendments to this Report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming that all said attorneys-in-fact and agents, or any of them or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated:
/S/ DAVID T. HUNG, M.D. David T. Hung, M.D. |
President, Chief Executive Officer and Director (Principal Executive Officer) |
February 29, 2012 | ||
/S/ C. PATRICK MACHADO C. Patrick Machado |
Chief Business Officer and Chief Financial Officer (Principal Financial and Accounting Officer) | February 29, 2012 | ||
/S/ DANIEL D. ADAMS Daniel D. Adams |
Director | February 29, 2012 | ||
/S/ GREGORY H. BAILEY Gregory H. Bailey |
Director | February 29, 2012 | ||
/S/ KIM D. BLICKENSTAFF Kim D. Blickenstaff |
Director | February 29, 2012 | ||
W. Anthony Vernon |
Director |
60
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of
Medivation, Inc.
In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of operations, of cash flows and of stockholders equity present fairly, in all material respects, the financial position of Medivation, Inc. and its subsidiaries (the Company) at December 31, 2011 and December 31, 2010 and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2011 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2011, based on criteria established in Internal ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Companys management is responsible for these financial statements, for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in Managements Report on Internal Control over Financial Reporting appearing under Item 9A. Our responsibility is to express opinions on these financial statements and on the Companys internal control over financial reporting based on our integrated 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 audits to obtain reasonable assurance about whether the financial statements are free of material misstatement and whether effective internal control over financial reporting was maintained in all material respects. Our audits of the financial statements included examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.
A companys 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 companys internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) 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 (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Companys 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.
/s/ PricewaterhouseCoopers LLP
San Jose, California
February 29, 2012
61
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
December 31, 2011 |
December 31, 2010 |
|||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 70,136 | $ | 107,717 | ||||
Short-term investments |
74,996 | 100,039 | ||||||
Receivable from collaboration partners |
12,545 | 21,188 | ||||||
Prepaid expenses and other current assets |
10,512 | 8,067 | ||||||
|
|
|
|
|||||
Total current assets |
168,189 | 237,011 | ||||||
Property and equipment, net |
720 | 862 | ||||||
Restricted cash |
5,489 | 843 | ||||||
Other non-current assets |
719 | 887 | ||||||
|
|
|
|
|||||
Total assets |
$ | 175,117 | $ | 239,603 | ||||
|
|
|
|
|||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 5,588 | $ | 3,229 | ||||
Accrued expenses |
24,014 | 21,399 | ||||||
Deferred revenue |
59,762 | 59,153 | ||||||
Other current liabilities |
270 | 5,193 | ||||||
|
|
|
|
|||||
Total current liabilities |
89,634 | 88,974 | ||||||
Deferred revenue, net of current |
83,509 | 141,507 | ||||||
Other non-current liabilities |
653 | 1,438 | ||||||
|
|
|
|
|||||
Total liabilities |
173,796 | 231,919 | ||||||
Commitments and contingencies (Note 11) |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $0.01 par value per share; 1,000,000 shares authorized; no shares issued and outstanding |
| | ||||||
Common stock, $0.01 par value per share; 50,000,000 shares authorized; issued and outstanding shares of 35,731,838 at December 31, 2011 and 34,573,829 at December 31, 2010 |
357 | 346 | ||||||
Additional paid-in capital |
251,242 | 218,786 | ||||||
Accumulated other comprehensive gain |
13 | 2 | ||||||
Accumulated deficit |
(250,291 | ) | (211,450 | ) | ||||
|
|
|
|
|||||
Total stockholders equity |
1,321 | 7,684 | ||||||
|
|
|
|
|||||
Total liabilities and stockholders equity |
$ | 175,117 | $ | 239,603 | ||||
|
|
|
|
SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
62
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Years ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Collaboration revenue |
$ | 60,389 | $ | 62,508 | $ | 69,254 | ||||||
Operating expenses: |
||||||||||||
Research and development |
73,432 | 72,228 | 87,728 | |||||||||
Selling, general and administrative |
29,887 | 23,005 | 28,983 | |||||||||
|
|
|
|
|
|
|||||||
Total operating expenses |
103,319 | 95,233 | 116,711 | |||||||||
|
|
|
|
|
|
|||||||
Loss from operations |
(42,930 | ) | (32,725 | ) | (47,457 | ) | ||||||
Other (expense) income, net |
(242 | ) | 260 | 976 | ||||||||
|
|
|
|
|
|
|||||||
Net loss before income tax (benefit) expense |
(43,172 | ) | (32,465 | ) | (46,481 | ) | ||||||
Income tax (benefit) expense |
(4,331 | ) | 1,572 | 8,272 | ||||||||
|
|
|
|
|
|
|||||||
Net loss |
$ | (38,841 | ) | $ | (34,037 | ) | $ | (54,753 | ) | |||
|
|
|
|
|
|
|||||||
Basic and diluted net loss per common share |
$ | (1.11 | ) | $ | (0.99 | ) | $ | (1.71 | ) | |||
|
|
|
|
|
|
|||||||
Weighted-average common shares used in the calculation of basic and diluted net loss per common share |
34,960 | 34,290 | 32,094 | |||||||||
|
|
|
|
|
|
SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
63
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Years ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (38,841 | ) | $ | (34,037 | ) | $ | (54,753 | ) | |||
Adjustments to reconcile net loss to net cash flows used in operating activities: |
||||||||||||
Amortization of deferred revenue |
(60,389 | ) | (62,508 | ) | (69,254 | ) | ||||||
Stock-based compensation |
13,885 | 13,530 | 10,726 | |||||||||
Depreciation and amortization |
430 | 465 | 311 | |||||||||
Accretion of discount on securities |
(65 | ) | (281 | ) | (1,081 | ) | ||||||
Changes in operating assets and liabilities: |
||||||||||||
Receivable from collaboration partners |
8,643 | (14,698 | ) | (2,968 | ) | |||||||
Prepaid expenses and other current assets |
(1,945 | ) | (224 | ) | (5,450 | ) | ||||||
Other assets |
166 | (322 | ) | 78 | ||||||||
Accounts payable |
2,359 | (1,611 | ) | (2,326 | ) | |||||||
Accrued expenses |
2,504 | 9,345 | 6,282 | |||||||||
Other current liabilities |
(4,923 | ) | 4,393 | 706 | ||||||||
Deferred revenue |
3,000 | 10,000 | 110,000 | |||||||||
Other non-current liabilities |
(785 | ) | 884 | 144 | ||||||||
|
|
|
|
|
|
|||||||
Net cash used in operating activities |
(75,961 | ) | (75,064 | ) | (7,585 | ) | ||||||
|
|
|
|
|
|
|||||||
Cash flows from investing activities: |
||||||||||||
Purchase of short-term investments |
(74,956 | ) | (209,888 | ) | (342,437 | ) | ||||||
Maturities of short-term investments |
100,075 | 331,000 | 272,000 | |||||||||
Purchase of property and equipment |
(286 | ) | (197 | ) | (631 | ) | ||||||
Change in restricted cash |
(5,146 | ) | 1,500 | (1,500 | ) | |||||||
|
|
|
|
|
|
|||||||
Net cash provided by (used in) investing activities |
19,687 | 122,415 | (72,568 | ) | ||||||||
|
|
|
|
|
|
|||||||
Cash flows from financing activities: |
||||||||||||
Proceeds from stock option and warrant exercises |
15,734 | 2,625 | 3,389 | |||||||||
Net proceeds from stockholder securities law settlement |
2,959 | | | |||||||||
Proceeds from issuance of common stock, net of issuance costs |
| | 62,059 | |||||||||
Excess tax benefits from stock-based compensation |
| 278 | 714 | |||||||||
|
|
|
|
|
|
|||||||
Net cash provided by financing activities |
18,693 | 2,903 | 66,162 | |||||||||
|
|
|
|
|
|
|||||||
Net (decrease) increase in cash and cash equivalents |
(37,581 | ) | 50,254 | (13,991 | ) | |||||||
Cash and cash equivalents at beginning of year |
107,717 | 57,463 | 71,454 | |||||||||
|
|
|
|
|
|
|||||||
Cash and cash equivalents at end of year |
$ | 70,136 | $ | 107,717 | $ | 57,463 | ||||||
|
|
|
|
|
|
|||||||
Supplemental disclosures of cash flow information: |
||||||||||||
Income taxes paid |
$ | 5,358 | $ | | $ | 8,400 | ||||||
Receivable from stock option exercises |
$ | | $ | | $ | 436 |
SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
64
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
(in thousands, except share data)
COMMON STOCK | ADDITIONAL PAID-IN CAPITAL |
ACCUMULATED OTHER COMPREHENSIVE INCOME |
ACCUMULATED DEFICIT |
TOTAL STOCKHOLDERS EQUITY |
||||||||||||||||||||
SHARES | AMOUNT | |||||||||||||||||||||||
Balances at January 1, 2009 |
30,088,390 | $ | 301 | $ | 125,074 | $ | 693 | $ | (122,660 | ) | $ | 3,408 | ||||||||||||
Common stock issued: |
||||||||||||||||||||||||
In the June 2009 financing |
3,162,500 | 32 | 62,396 | | | 62,428 | ||||||||||||||||||
Upon exercise of stock options and warrants |
553,006 | 5 | 3,820 | | | 3,825 | ||||||||||||||||||
Upon vesting of restricted stock units |
19,166 | | | | | | ||||||||||||||||||
Offering expenses |
| | (369 | ) | | | (369 | ) | ||||||||||||||||
Stock-based compensation expense |
| | 10,726 | | | 10,726 | ||||||||||||||||||
Excess tax benefit from employee stock plan awards |
| | 714 | | | 714 | ||||||||||||||||||
Net loss |
| | | | (54,753 | ) | (54,753 | ) | ||||||||||||||||
Change in unrealized gain (loss) on available-for-sale securities |
| | | (705 | ) | | (705 | ) | ||||||||||||||||
|
|
|||||||||||||||||||||||
Comprehensive loss |
| | | | | (55,458 | ) | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances at December 31, 2009 |
33,823,062 | 338 | 202,361 | (12 | ) | (177,413 | ) | 25,274 | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Common stock issued: |
||||||||||||||||||||||||
Upon exercise of stock options and warrants |
740,767 | 8 | 2,617 | | | 2,625 | ||||||||||||||||||
Upon vesting of restricted stock units |
10,000 | | | | | | ||||||||||||||||||
Stock-based compensation expense |
| | 13,530 | | | 13,530 | ||||||||||||||||||
Excess tax benefit from employee stock plan awards |
| | 278 | | | 278 | ||||||||||||||||||
Net loss |
| | | | (34,037 | ) | (34,037 | ) | ||||||||||||||||
Change in unrealized gain (loss) on available-for-sale securities |
| | | 14 | | 14 | ||||||||||||||||||
|
|
|||||||||||||||||||||||
Comprehensive loss |
| | | | | (34,023 | ) | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances at December 31, 2010 |
34,573,829 | 346 | 218,786 | 2 | (211,450 | ) | 7,684 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Common stock issued: |
||||||||||||||||||||||||
Upon exercise of stock options |
1,106,403 | 11 | 15,723 | | | 15,734 | ||||||||||||||||||
Upon vesting of restricted stock units |
51,606 | | | | | | ||||||||||||||||||
Stock-based compensation expense |
| | 13,774 | | | 13,774 | ||||||||||||||||||
Net proceeds from stockholder securities law settlement |
| | 2,959 | | | 2,959 | ||||||||||||||||||
Net loss |
| | | | (38,841 | ) | (38,841 | ) | ||||||||||||||||
Change in unrealized gain on available-for-sale securities |
| | | 11 | | 11 | ||||||||||||||||||
|
|
|||||||||||||||||||||||
Comprehensive loss |
| | | | | (38,830 | ) | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances at December 31, 2011 |
35,731,838 | $ | 357 | $ | 251,242 | $ | 13 | $ | (250,291 | ) | $ | 1,321 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
65
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2011
1. DESCRIPTION OF BUSINESS
Medivation, Inc. (the Company or Medivation) is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Together with its collaboration partner, Astellas Pharma, Inc., or Astellas, the Company is developing MDV3100 for multiple stages of advanced prostate cancer. The Company has completed the Phase 3 AFFIRM trial in the latest stage patients those who have already failed docetaxel-based chemotherapy and is conducting an additional Phase 3 and two Phase 2 trials in men with earlier stages of advanced prostate cancer.
The Company has not generated any revenue from product sales to date. The Company has funded its operations primarily through private and public offerings of its common stock and from the up-front, development milestone and cost-sharing payments under its collaboration agreement with Astellas and its former collaboration agreement with Pfizer Inc., or Pfizer. The Company has incurred cumulative net losses of $250.3 million through December 31, 2011 and it expects to incur substantial additional losses for the foreseeable future as it pursues regulatory approval for, and, if approved, commercial launch of MDV3100 and continues to finance clinical and preclinical studies of its existing and potential future product candidates and its corporate overhead costs.
(a) Astellas Collaboration Agreement
The Company entered into a collaboration agreement with Astellas in October 2009, pursuant to which it received a non-refundable up-front cash payment of $110.0 million in the fourth quarter of 2009. The Company subsequently received development milestone payments of $10.0 million and $3.0 million in the fourth quarter of 2010 and the second quarter of 2011, respectively. The Company recorded development and commercialization cost-sharing payments from Astellas totaling $43.8 million, $34.6 million and $2.9 million during the years ended December 31, 2011, 2010 and 2009, respectively, pursuant to the terms of the Astellas Collaboration Agreement, which is discussed further in Note 3, Collaboration Agreements. The Company refers to its collaboration agreement with Astellas as the Astellas Collaboration Agreement.
In November 2011, the Company reported positive results from a planned interim analysis of its Phase 3 AFFIRM trial in advanced prostate cancer patients previously treated with docetaxel-based chemotherapy. In February 2012, the Company reported further positive results from the AFFIRM trial at the American Society of Clinical Oncologys 2012 Genitourinary Cancers Symposium. Based on the positive results from the AFFIRM trial, the Company elected to exercise its right under the Astellas Collaboration Agreement to co-promote MDV3100 in the U.S. market. Should MDV3100 receive marketing approval, the Company will provide 50% of the sales and medical affairs field forces supporting MDV3100 in the U.S. market.
(b) Former Collaboration Agreement with Pfizer
The Company entered into a collaboration agreement with Pfizer in October 2008, pursuant to which it received a non-refundable up-front cash payment of $225.0 million in the fourth quarter of 2008. The Company recorded development and commercialization cost-sharing payments from Pfizer totaling $12.4 million, $28.1 million and $19.7 million during the years ended December 31, 2011, 2010 and 2009, respectively, pursuant to the terms of the collaboration agreement, which is discussed further in Note 3, Collaboration Agreements.
In January 2012, the Company reported negative top line results from its Phase 3 CONCERT trial of dimebon in patients with mild-to-moderate Alzheimers disease. The Company previously had reported negative top line results from its Phase 3 CONNECTION trial of dimebon in patients with mild-to-moderate Alzheimers
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disease and its Phase 3 HORIZON trial of dimebon in patients with Huntington disease. In January 2012, Pfizer exercised its right to terminate the collaboration agreement and the Company and Pfizer discontinued the development of dimebon for all indications in 2012 as discussed further in Note 14, Subsequent Events. The Company refers to its collaboration agreement with Pfizer as the former collaboration agreement with Pfizer.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(a) Basis of Consolidation; Business Segments
The consolidated financial statements incorporate the accounts of Medivation, Inc. and its wholly-owned subsidiaries. All significant inter-company transactions and balances have been eliminated in consolidation. The Company operates in one business segment.
All tabular disclosures of dollar amounts are presented in thousands. All share and per share amounts are presented at their actual amounts.
(b) Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States, or U.S. GAAP, requires that management make estimates and assumptions in certain circumstances that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates and assumptions used by management principally relate to the performance periods of the Companys deliverables under its collaboration agreement with Astellas and its former collaboration agreement with Pfizer; services performed by third parties but not yet invoiced; the fair value and forfeiture rates of stock awards granted to employees, directors and consultants and the probability of attaining the performance objectives of performance share awards; the probability and potential magnitude of contingent liabilities; and deferred income taxes, income tax provisions and accruals for uncertain income tax positions.
Although management believes that estimates used in the preparation of the consolidated financial statements are reasonable under the circumstances, actual future results could differ from those estimates. In addition, had different estimates and assumptions been used, the consolidated financial statements could have differed materially from that which is presented.
(c) Risks and Uncertainties
The Company has incurred cumulative net losses of $250.3 million through December 31, 2011 and it expects to incur substantial additional losses for the foreseeable future as it pursues regulatory approval for, and, if approved, commercial launch of MDV3100 and continues to finance clinical and preclinical studies of its existing and potential future product candidates and its corporate overhead costs. At December 31, 2011, the Company had cash, cash equivalents and short-term investments totaling $145.1 million to fund its operations. The Company expects that its current resources will be sufficient to fund the presently budgeted costs of executing its current development and commercialization plan for the next 12 months. However, this statement is subject to significant risks and uncertainty and is based on a number of assumptions that may prove to be wrong and the Company could exhaust its available cash, cash equivalents and short-term investments earlier than presently anticipated. The Company may be required or choose to seek additional capital within the next 12 months to expand its clinical development activities for MDV3100 based on the positive results of the Companys Phase 3 AFFIRM trial in post-chemotherapy advanced prostate cancer patients, to fund costs of planning for and executing a commercial launch of MDV3100, should it receive marketing approval, if the Company faces challenges or delays in connection with its clinical trials or the potential approval and commercialization of MDV3100, or to maintain cash balances that the Company deems reasonable and prudent. The Companys ability to raise capital on acceptable terms, or at all, is subject to significant risks, many of which are beyond its control.
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(d) Cash Equivalents
Cash and cash equivalents are stated at cost, which approximates fair market value. The Company considers all highly liquid investments with a remaining maturity of three months or less at the time of acquisition to be cash equivalents.
(e) Short-Term Investments
The Company considers all highly liquid investments with a remaining maturity at the time of acquisition of more than three months but no longer than 12 months to be short-term investments. The Company classifies its short-term investments as available-for-sale securities and reports them at fair value with related unrealized gains and losses included as a component of stockholders equity. The amortized cost of debt securities in this category is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in other (expense) income, net, on the consolidated statements of operations. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in other (expense) income, net. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in other (expense) income, net.
(f) Restricted Cash
Restricted cash represents certificates of deposit held in the Companys name with a major financial institution to secure the Companys contingent obligations under irrevocable letters of credit issued to the lessors of the Companys office facilities.
(g) Fair Value of Financial Instruments
The fair value of the Companys cash equivalents and short-term investments is based on quoted market prices. Other financial instruments, including receivables from collaboration partners, accounts payable and accrued expenses, are carried at cost, which the Company believes approximates fair value because of the short-term maturities of these instruments.
(h) Concentration of Credit Risk
Financial instruments that potentially subject the Company to credit risk consist of cash, cash equivalents, short-term investments and receivables from collaboration partners. The Companys current investment policy is to invest only in a) debt securities issued by, or backed by the full faith and credit of, the U.S. government, b) repurchase agreements that are fully collateralized by such debt securities, and c) money market funds invested exclusively in the types of securities described in a) and b) above. Given this investment policy, the Company does not believe its exposure to credit risk with respect to the issuers of the securities in which it invests is material, and accordingly has no formal policy for mitigating such risk. The Companys cash and cash equivalents are primarily invested in deposits and money market accounts with one major financial institution in the United States. Deposits in this financial institution may exceed the amount of insurance provided on such deposits.
(i) Property and Equipment
Property and equipment are recorded at cost, less accumulated depreciation and amortization. Repairs and maintenance costs are expensed in the period incurred. Property and equipment is depreciated on a straight-line basis over the estimated useful lives of the assets as follows:
Description |
Estimated Useful Life | |
Office equipment and furniture |
3 years | |
Software and computer equipment |
3-5 years | |
Laboratory equipment |
5 years | |
Leasehold improvements and fixtures |
Lesser of estimated useful life or life of lease |
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(j) Leases
At the inception of a lease, the Company evaluates the lease agreement to determine whether the lease is an operating or a capital lease using the criteria in the Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, 840, Leases. For operating leases, the Company recognizes rent expense on a straight-line basis over the non-cancellable lease term and records the difference between cash rent payments and the recognition of rent expense as a deferred liability. Where lease agreements contain rent escalation clauses, rent abatements and/or concessions, such as rent holidays and tenant improvement allowances, the Company applies them in the determination of straight-line expense over the lease term. The Company currently has no capital leases. Certain lease agreements also require the Company to make additional payments under the lease term for taxes, insurance, and other operating expenses incurred during the lease period, which are expensed as incurred.
(k) Litigation
The Company records an accrual for exposures to various litigation matters as a charge to its consolidated statements of operations when it becomes probable and can be reasonably estimated. The exposure to legal matters is evaluated and estimated, if possible, following consultation with legal counsel. Such estimates are based on currently available information and, given the subjective nature and complexities inherent in making these estimates, the ultimate outcome of the Companys legal matters may be different than the amounts estimated, if any.
(l) Collaboration Agreement Payments
The Company accounts for the various payment flows under its collaboration agreement with Astellas and its former collaboration agreement with Pfizer in a consistent manner, as follows:
Estimated Performance Periods
Both the Astellas Collaboration Agreement and the former collaboration agreement with Pfizer contain multiple elements and deliverables, and required evaluation pursuant to ASC 605-25, Revenue RecognitionMultiple-Element Arrangements. The Company evaluated the facts and circumstances of the collaboration agreements to determine whether it had obligations constituting deliverables under ASC 605-25. The Company concluded that it had multiple deliverables under both collaboration agreements, including deliverables relating to grants of technology licenses, and performance of manufacturing, regulatory and clinical development activities in the U.S. In the case of the Astellas Collaboration Agreement, the period in which the Company performs its deliverables began in the fourth quarter of 2009 and at December 31, 2011, management estimated that it would be completed in the fourth quarter of 2014. In the case of the former collaboration agreement with Pfizer, the period in which the Company performs its deliverables began in the fourth quarter of 2008 and at December 31, 2011, management estimated that it would be completed in the fourth quarter of 2013. The Company also concluded that its deliverables under each collaboration agreement should be accounted for as a single unit of accounting under ASC 605-25.
Estimation of the performance periods of the Companys deliverables requires the use of managements judgment. Significant factors considered in managements evaluation of the estimated performance periods include, but are not limited to, the Companys experience, along with Astellas and Pfizers experience, in conducting clinical development and regulatory activities. The Company reviews the estimated duration of its performance periods under both collaborations on a quarterly basis and makes any appropriate adjustments on a prospective basis.
During the year ended December 31, 2010, the Company extended the estimated completion date of its performance period under the former collaboration agreement with Pfizer from the second quarter of 2012 to the fourth quarter of 2013, based on the failure of the CONNECTION trial and the resulting longer period required to
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complete the clinical trials evaluating dimebons potential safety and efficacy as a treatment for mild-to-moderate Alzheimers disease.
In January 2012, Pfizer exercised its right to terminate the collaboration agreement. As a result, during the first quarter of 2012, the Company revised its estimate of the remaining performance period under the collaboration agreement. The Company expects to complete its remaining performance obligations pursuant to the terms of the former collaboration agreement with Pfizer in the first half of 2012.
Future changes in estimates of the performance periods under the collaboration agreements could significantly impact the timing of future revenue recognized under the applicable collaboration agreement.
Up-Front Payments
The Company has received non-refundable up-front cash payments of $110.0 million and $225.0 million under its collaboration agreement with Astellas and its former collaboration agreement with Pfizer, respectively. The Company recognizes these payments as collaboration revenue on a straight-line basis over the applicable estimated performance period.
Milestone Payments
The Company is eligible to receive milestone payments under the Astellas Collaboration Agreement based on achievement of specified development, regulatory and commercial events. Management evaluated the nature of the events triggering these contingent payments, and concluded that these eventsexcept for (a) those relating to regulatory activities in Europe, development and regulatory activities in Japan, and commercial activities, all of which are areas in which the Company has no pertinent contractual responsibilities, and (b) the initiation of the Phase 3 PREVAIL trial, an event which management deemed to be reasonably assured at the inception of the Astellas collaborationconstituted substantive milestones. This conclusion was based primarily on the facts that (i) each triggering event represents a specific outcome that can be achieved only through successful performance by the Company of one or more of its deliverables, (ii) achievement of each triggering event was subject to inherent risk and uncertainty and would result in additional payments becoming due to the Company, (iii) each of these milestones was substantive, based primarily on the facts that the payments they trigger are non-refundable, (iv) achievement of the milestone entails risk and was not reasonably assured at inception of the collaboration agreement, (v) substantial effort is required to complete each milestone, (vi) the amount of each milestone payment is reasonable in relation to the value created in achieving the milestone, (vii) a substantial amount of time is expected to pass between the up-front payment and the potential milestone payments, and (viii) the milestone payments relate solely to past performance. Based on the foregoing, the Company will recognize any revenue from these milestone payments under the substantive milestone method in the period in which the underlying triggering event occurs.
For the contingent payments triggered by events that do not constitute substantive milestones, management concluded that the appropriate revenue recognition treatment depends on whether the triggering event occurs during or after the performance period. Where the triggering event occurs during the applicable performance period, the Company will amortize any revenue from this event on a straight-line basis over the applicable performance period. Where the triggering event occurs after the applicable performance period, the Company will recognize the associated revenue in the period in which the event occurs.
Royalties and Profit Sharing Payments
Under the Astellas Collaboration Agreement, the Company is eligible to receive profit sharing payments on sales of products in the U.S. and royalties on sales of products outside the U.S. The Company will recognize any revenue from these events based on the revenue recognition criteria set forth in ASC 605-10-25-1, Revenue Recognition. Based on those criteria, the Company considers these potential payments to be contingent revenues, and will recognize them as revenue in the period in which the applicable contingency is resolved.
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Cost-Sharing Payments
Under both the Astellas Collaboration Agreement and the former collaboration agreement with Pfizer, the Company and its collaboration partners share certain development and commercialization costs in the U.S. The parties make quarterly cost-sharing payments to one another in amounts necessary to ensure that each party bears its contractual share of the overall development and commercialization costs incurred. The Companys policy is to account for cost-sharing payments to its collaboration partners as increases in expense in its consolidated statements of operations, while cost sharing payments by its collaboration partners to the Company are presented as reductions in expense. Cost-sharing payments related to development activities and commercialization activities are recorded in research and development expenses and selling, general and administrative expenses, respectively.
(m) Research and Development
Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services. Research and development costs are expensed as incurred. In instances where the Company enters into agreements with third parties to provide research and development services to it, costs are expensed as services are performed. Amounts due under such arrangements may be either fixed fee or fee for service, and may include upfront payments, monthly payments, and payments upon the completion of milestones or receipt of deliverables.
The Companys cost accruals for clinical trials and other research and development activities are based on estimates of the services received and efforts expended pursuant to contracts with numerous clinical trial centers and contract research organizations. In the normal course of business the Company contracts with third parties to perform various research and development activities in the on-going development of its product candidates, including without limitation, third party clinical trial centers and contract research organizations that perform and administer the Companys clinical trials on its behalf. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Payments under these agreements depend on factors such as the achievement of certain events, the successful enrollment of patients, and the completion of portions of the clinical trial or similar conditions. The objective of the Companys accrual policy is to match the recording of expenses in its consolidated financial statements to the actual services received and efforts expended. As such, expense accruals related to clinical trials and other research and development activities are recognized based on the Companys estimate of the degree of completion of the event or events specified in the specific agreement.
The Companys estimates are dependent upon the time lines and accuracy of data provided by third parties regarding the status and cost of studies, and may not match the actual services performed by the organizations. This could result in adjustment to the Companys research and development expense in future periods. To date, the Company has had no significant adjustments.
(n) Stock-Based Compensation
The Company has granted stock options, restricted stock units, performance share awards and stock appreciation rights pursuant to the terms of its Amended and Restated 2004 Equity Incentive Award Plan. The Company accounts for stock-based compensation awards granted to employees and directors in accordance with ASC 718, Stock Compensation, and has applied the provisions of the Securities and Exchange Commission, or SEC, Staff Accounting Bulletin, or SAB, No. 107 and No. 110, in its application of ASC 718. Stock compensation arrangements with consultants are accounted for in accordance with ASC 718 and ASC 505-50, Equity-Based Payments to Non-Employees, using a fair value approach. The compensation costs of these arrangements are subject to remeasurement over the vesting terms as earned.
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The Company determines stock-based compensation expense associated with stock options based on the estimated grant date fair value using the Black-Scholes valuation model, which requires the use of subjective assumptions related to expected stock price volatility, expected option term, expected dividend yield and risk-free interest rate. For employee and director stock options, the Company recognizes compensation expense over the vesting period of the awards that are ultimately expected to vest. Stock options granted to consultants are valued at their respective measurement dates and recognized as expense based on the portion of the total consulting services provided during the applicable period. As further consulting services are provided in each period, the Company revalues the associated awards and recognizes additional expense based on their then-current fair values.
Stock-based compensation expense associated with restricted stock units is based on the fair value of the Companys common stock on the grant date, which equals the closing market price of the Companys common stock on the grant date of the award. For restricted stock units, the company recognizes compensation expense over the vesting period of the awards that are ultimately expected to vest.
Performance share awards allow the recipients of such awards to earn fully vested shares of the Companys common stock based on the achievement of pre-established performance objectives specified in the awards. Stock-based compensation expense associated with performance share awards is based on the estimated grant date fair value of the Companys common stock using the Black Scholes valuation model and is recognized based upon the Companys best estimates of the achievement of the performance objectives specified in such awards and the resulting number of shares that are expected to be earned. The Company evaluates on a quarterly basis the probability of achieving the performance criteria. The cumulative effect on current and prior periods of a change in the estimated number of performance share awards expected to be earned is recognized as compensation expense or as reduction of previously recognized compensation expense in the period of the revised estimate.
The fair value of stock-settled and cash-settled stock appreciation rights is initially measured on the grant date using the Black-Scholes valuation model, which requires the use of subjective assumptions related to the expected stock price volatility, expected term, expected dividend yield and risk-free interest rate. Similar to stock options, compensation expense for stock-settled stock appreciation rights is recognized over the vesting period of the awards that are ultimately expected to vest based on the grant-date fair value. Cash-settled stock appreciation rights are liability-classified awards for which compensation expense and the liability are remeasured at each reporting date through the date of settlement based on the portion of the requisite service period rendered.
The Company applies a forfeiture rate when determining stock-based compensation expense to account for an estimate of the granted awards not expected to vest. If actual forfeitures differ from the expected rate, the Company may be required to make additional adjustments to compensation expense in future periods.
(o) Promotional and Advertising Costs
Promotional and advertising costs are classified as selling, general and administrative expenses, and are expensed as incurred. Promotional and advertising expenses consist primarily of the costs of designing, producing and distributing materials promoting the Company or its product candidates, including its corporate website. Promotional and advertising expenses were insignificant in the years ended December 31, 2011, 2010 and 2009.
(p) Income Taxes
The Company accounts for income taxes using an asset and liability approach in ASC 740-10, Accounting for Income Taxes, which requires the recognition of taxes payable or refundable for the current year and deferred tax assets and liabilities for the future tax consequences of events that have been recognized in the consolidated financial statements or tax returns. The measurement of current and deferred tax assets and
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liabilities is based on provisions of the enacted tax law; the effects of future changes in tax laws or rates are not anticipated. The measurement of deferred tax assets is reduced, if necessary, by the amount of any tax benefits that, based on available evidence, is not expected to be realized.
The Company records a valuation allowance to reduce its deferred tax assets for the amount that it believes is more likely than not to be realized. Due to the Companys lack of earnings history, the Company intends to maintain a full valuation allowance on the U.S. deferred tax assets until sufficient positive evidence exists to support reversal of the valuation allowance.
The Company establishes reserves for uncertain income tax positions based on the guidance in ASC 740-10-25, Accounting for Uncertainty in Income Taxes. When establishing reserves for uncertain income tax positions, the Company considers the technical support for the positions, past audit experience with similar situations and potential interest and penalties related to the matters. Recorded reserves represent the Companys best estimate of the amount, if any, that it may ultimately be required to pay to settle such matters. The resolution of uncertain income tax positions is dependent on uncontrollable factors such as law changes, new case law and the willingness of income tax authorities to settle, including the timing thereof and other factors. The Company does not expect significant changes to its uncertain income tax positions in the next 12 months. However, items outside of the Companys control could cause its uncertain income tax positions to change in the future, which would be recorded in the consolidated statements of operations. The Companys practice is to recognize interest and/or penalties related to income tax matters in income tax expense as incurred.
(q) Basic and Diluted Net Loss per Common Share
Basic net loss per common share is computed by dividing the net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per common share is computed similarly to basic net loss per common share, except that the denominator is increased to include all potentially dilutive common shares, including outstanding options, warrants, restricted stock units, performance share awards and stock appreciation rights. Potentially dilutive common shares have been excluded from the diluted net loss per common share computations in all periods presented because such securities have an anti-dilutive effect on net loss per common share due to the Companys net loss in each of the years presented.
Potentially dilutive securities were as follows:
December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Stock options |
4,301,808 | 5,041,303 | 5,603,960 | |||||||||
Restricted stock units |
101,617 | 173,119 | 10,834 | |||||||||
Warrants |
22,904 | 22,904 | 100,323 | |||||||||
Stock appreciation rights |
262,800 | | | |||||||||
Performance shares eligible to be earned |
62,500 | | | |||||||||
|
|
|
|
|
|
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Total |
4,751,629 | 5,237,326 | 5,715,117 | |||||||||
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|
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(r) Recently Issued Accounting Pronouncements Impacting the Company
In June 2011, the FASB issued Accounting Standards Update, or ASU, No. 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income, with an objective of increasing the prominence of items reported in other comprehensive income, or OCI. This amendment provides companies with the option to present the total of comprehensive income, the components of net income and the components of OCI in either a single continuous statement of comprehensive income or in two separate but continuous statements. In addition, companies must present on the face of the financial statements, items reclassified from OCI to net income in the section of the financial statements where the components of net income and OCI are presented, regardless of the option selected to present comprehensive income. The amended guidance related to the presentation of
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comprehensive income is applicable retrospectively and is effective for fiscal years and interim periods within those fiscal years, beginning after December 15, 2011 and will be effective for the Company in the first quarter of fiscal 2012. In December 2011, the FASB issued ASU No. 2011-12, which defers changes in ASU No. 2011-05 that relate to the presentation of reclassification adjustments out of accumulated OCI to enable the FASB time to re-deliberate the presentation requirements. The adoption of this amendment concerns disclosure only and the Company does not expect it to have an impact on its consolidated financial position, results of operations or cash flows.
In May 2011, the FASB issued ASU No. 2011-04, Fair Value Measurement (Topic 820): Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs. This amendment is intended to result in convergence between U.S. GAAP and International Financial Reporting Standards requirements for measurement of and disclosures about fair value. This guidance clarifies the application of existing fair value measurements and disclosures, and changes certain principles or requirements for fair value measurements and disclosures. The amendment will be effective for the Company in the second quarter of fiscal year 2012. The Company is currently assessing the potential impact, if any, this amendment may have on its consolidated financial position, results of operations and cash flows.
In March 2010, the FASB ratified Emerging Issues Task Force, or EITF, Issue No. 08-9, Milestone Method of Revenue Recognition (Issue 08-9). The ASU, resulting from Issue 08-9 amends ASC 605-28. The Task Force concluded that the milestone method is a valid application of the proportional performance model when applied to research or development arrangements. Accordingly, the consensus states that an entity can make an accounting policy election to recognize a payment that is contingent upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. A milestone is defined in the consensus as an event: (1) that can only be achieved based in whole or in part on either (a) the entitys performance or (b) on the occurrence of a specific outcome resulting from the entitys performance; (2) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved; and (3) that would result in additional payments being due to the entity. Issue 08-9 is effective for fiscal years, and interim periods within those years, beginning on or after June 15, 2010, and may be applied either prospectively to milestones achieved after the adoption date, or; retrospectively for all periods presented. The Company adopted the new guidance effective January 1, 2011, analyzed its impact on its consolidated financial statements, and concluded there was no such impact.
In September 2009, the FASB amended ASC 605 as summarized in ASU 2009-13, Revenue Recognition: Multiple-Deliverable Revenue Arrangements. Guidance in ASC 605-25 on revenue arrangements with multiple deliverables has been amended to require an entity to allocate revenue to deliverables in an arrangement using its best estimate of selling prices if the vendor does not have vendor-specific objective evidence or third-party evidence of selling prices, and to eliminate the use of the residual method and require the entity to allocate revenue using the relative selling price method. The new guidance also requires expanded quantitative and qualitative disclosures about revenue from arrangements with multiple deliverables. The update is effective for fiscal years beginning on or after June 15, 2010, with early adoption permitted. Adoption may either be on a prospective basis for new revenue arrangements entered into or existing arrangements modified, after adoption of the update, or by retrospective application. The Company adopted this guidance on a prospective basis effective January 1, 2011, analyzed its impact on its consolidated financial statements, and concluded there was no such impact.
3. COLLABORATION AGREEMENTS
(a) Collaboration Agreement with Astellas
The Company entered into a collaboration agreement with Astellas in October 2009. Under the Astellas Collaboration Agreement, the Company and Astellas agreed to collaborate on the development of MDV3100 for the United States market, including associated regulatory filings with the U.S. Food and Drug Administration, or
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the FDA. Based on the positive results from the AFFIRM trial, the Company elected to exercise its right under the Astellas Collaboration Agreement to co-promote MDV3100 in the U.S. market. Should MDV3100 receive marketing approval by the FDA, following such approval and the launch of MDV3100 in the United States, the Company and Astellas will co-promote MDV3100 in the United States and each will provide 50% of the sales and medical affairs field forces supporting MDV3100 in the U.S. market. Astellas is responsible for development of, seeking regulatory approval for and commercialization of MDV3100 outside the United States. Astellas will be responsible for commercial manufacture of MDV3100 on a global basis. Both Medivation and Astellas have agreed not to commercialize certain other products having a similar mechanism of action as MDV3100 for the treatment of specified indications for a specified time period, subject to certain exceptions.
The Company and Astellas share equally the costs and expenses of developing and commercializing MDV3100 for the United States market, except that (a) development costs for studies useful in both the United States market and either Europe or Japan are shared two-thirds by Astellas and one-third by the Company, and (b) both the Company and Astellas will be responsible for all commercialization costs incurred in fielding and supporting its respective MDV3100 sales forces, and each of Astellas and the Company will be entitled to receive a fee for each detail made by its respective sales forces. The Company and Astellas will share profits (or losses) resulting from the commercialization of MDV3100 in the United States equally. Outside the United States, Astellas will bear all development and commercialization costs and will pay the Company tiered, double-digit royalties on the aggregate net sales of MDV3100.
The agreement establishes several joint committees consisting of an equal number of representatives from both parties that operate by consensus to oversee the collaboration. In the event that a joint committee is unable to reach consensus on a particular issue, then, depending on the issue, a dispute may be decided at the joint committee level by the party with the final decision on the issue or escalated to senior management of the parties. If a dispute is escalated to senior management and no consensus is reached, then the dispute may be decided by the party to whom the contract grants final decision on such issue. Other issues can only be decided by consensus of the parties, and unless and until the parties representatives reach agreement on such issue, no decision on such issue will be made, and the status quo will be maintained.
Under the Astellas Collaboration Agreement, Astellas paid the Company a non-refundable, up-front cash payment of $110.0 million in the fourth quarter of 2009. The Company is also eligible to receive up to $335.0 million in development milestone payments, plus up to an additional $320.0 million in commercial milestone payments. As of December 31, 2011, the Company had received an aggregate of $13.0 million in development milestone payments under the Astellas Collaboration Agreement. Should the FDA or European Medicines Agency accept for filing a new drug application or marketing authorization application, respectively, seeking approval of MDV3100 in post-chemotherapy advanced prostate cancer patients based on the positive results from the AFFIRM trial, the Company would be entitled to a $10.0 million and a $5.0 million milestone payment, respectively, under the Astellas Collaboration Agreement. In addition, should the new drug application be approved by the FDA or the marketing authorization application be approved by the European regulators, the Company would be entitled to a $30.0 million and a $15.0 million milestone payment, respectively, under the Astellas Collaboration Agreement. The Company is required to share 10% of the up-front and development milestone payments received under the Astellas Collaboration Agreement with The Regents of the University of California, or UCLA, pursuant to the terms of its MDV3100 license agreement. The Company and Astellas each are permitted to terminate the Astellas Collaboration Agreement for an uncured material breach by, or the insolvency of, the other party. Astellas has a right to terminate the Astellas Collaboration Agreement unilaterally by advance written notice to the Company, but except in certain specific circumstances, generally cannot exercise that termination right until the first anniversary of MDV3100s first commercial sale. Following any termination of the Astellas Collaboration Agreement in its entirety, all rights to develop and commercialize MDV3100 will revert to the Company, and Astellas will grant a license to the Company to enable the Company to continue such development and commercialization. In addition, except in the case of a termination by Astellas for an uncured material breach, Astellas will supply MDV3100 to the Company during a specified transition period.
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(b) Former Collaboration Agreement with Pfizer
The Company entered into a collaboration agreement with Pfizer in October 2008. Under the agreement, the Company and Pfizer agreed to collaborate on the development of dimebon for Alzheimers disease and Huntington disease for the United States market, including associated regulatory filings with the FDA. Pfizer paid the Company a non-refundable up-front cash payment of $225.0 million in the fourth quarter of 2008 pursuant to the terms of the agreement. Under the terms of the former collaboration agreement with Pfizer, the Company and Pfizer shared the costs and expenses of developing and commercializing dimebon for the United States market on a 60%/40% basis, with Pfizer assuming the larger share.
Based on the negative results in the Phase 3 CONNECTION, HORIZON and CONCERT trials, the Company and Pfizer have discontinued development of dimebon for all indications in 2012. In January 2012, Pfizer exercised its right to terminate the collaboration agreement as discussed in Note 14, Subsequent Events.
(c) Deferred Revenue and Collaboration Revenue
Through December 31, 2011, the Company has received an aggregate of $123.0 million of up-front and development milestone payments under the Astellas Collaboration Agreement and $225.0 million of up-front payments under its former collaboration agreement with Pfizer.
Deferred revenue related to the Astellas Collaboration Agreement and the former collaboration agreement with Pfizer consisted of the following:
December 31, | ||||||||
2011 | 2010 | |||||||
Current portion: |
||||||||
Deferred revenue from Astellas |
$ | 23,747 | $ | 23,138 | ||||
Deferred revenue from Pfizer |
36,015 | 36,015 | ||||||
|
|
|
|
|||||
Total |
$ | 59,762 | $ | 59,153 | ||||
|
|
|
|
|||||
Long-term portion: |
||||||||
Deferred revenue from Astellas |
$ | 47,494 | $ | 69,477 | ||||
Deferred revenue from Pfizer |
36,015 | 72,030 | ||||||
|
|
|
|
|||||
Total |
$ | 83,509 | $ | 141,507 | ||||
|
|
|
|
Collaboration revenue recognized with respect to the Astellas Collaboration Agreement and the former collaboration agreement with Pfizer consisted of the following:
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Collaboration revenue from Astellas |
$ | 24,374 | $ | 23,492 | $ | 3,893 | ||||||
Collaboration revenue from Pfizer |
36,015 | 39,016 | 65,361 | |||||||||
|
|
|
|
|
|
|||||||
Total |
$ | 60,389 | $ | 62,508 | $ | 69,254 | ||||||
|
|
|
|
|
|
76
(d) Cost-Sharing Payments
The Company recorded development cost-sharing payments from Astellas and Pfizer, and corresponding reductions in research and development expense as follows:
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Development cost-sharing payments from Astellas |
$ | 44,285 | $ | 34,125 | $ | 2,784 | ||||||
Development cost-sharing payments from Pfizer |
12,365 | 29,139 | 20,435 | |||||||||
|
|
|
|
|
|
|||||||
Total |
$ | 56,650 | $ | 63,264 | $ | 23,219 | ||||||
|
|
|
|
|
|
The Company recorded commercialization cost-sharing payments (to) from Astellas and Pfizer, and corresponding (increases) reductions in selling, general and administrative expenses as follows:
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Commercialization cost-sharing payments (to) from Astellas |
$ | (472 | ) | $ | 520 | $ | 74 | |||||
Commercialization cost-sharing payments from (to) Pfizer |
32 | (1,084 | ) | (720 | ) | |||||||
|
|
|
|
|
|
|||||||
Total |
$ | (440 | ) | $ | (564 | ) | $ | (646 | ) | |||
|
|
|
|
|
|
At December 31, 2011 and 2010, development and commercialization cost-sharing payments receivable from Astellas were $10.6 million and $11.6 million, respectively, and at December 31, 2011 and 2010, development and commercialization cost-sharing payments receivable from Pfizer were $2.0 million and $9.6 million, respectively. The amounts receivable at December 31, 2011 from Astellas and Pfizer were received in the first quarter of 2012.
4. SHORT-TERM INVESTMENTS
At December 31, 2011, the amortized cost, gross unrealized gain and estimated fair value of available-for-sale securities, consisting of United States treasury bills maturing in January 2012 and May 2012, were $75.0 million, $0.0 million and $75.0 million, respectively.
At December 31, 2010, the amortized cost, gross unrealized gain and estimated fair value of available-for-sale securities, consisting of a United States treasury note maturing in April 2011 was $100.0 million, $0.0 million and $100.0 million, respectively.
5. PROPERTY AND EQUIPMENT, NET
The components of the Companys property and equipment, net, consisted of the following:
December 31, | ||||||||
2011 | 2010 | |||||||
Furniture and fixtures |
$ | 229 | $ | 221 | ||||
Leasehold improvements |
630 | 630 | ||||||
Computer equipment and software |
747 | 632 | ||||||
Laboratory equipment |
371 | 349 | ||||||
Construction in progress |
164 | 22 | ||||||
|
|
|
|
|||||
2,141 | 1,854 | |||||||
Less: accumulated depreciation and amortization |
(1,421 | ) | (992 | ) | ||||
|
|
|
|
|||||
Total |
$ | 720 | $ | 862 | ||||
|
|
|
|
77
6. ACCRUED EXPENSES
Accrued expenses consisted of the following:
December 31, | ||||||||
2011 | 2010 | |||||||
Payroll and payroll related |
$ | 1,112 | $ | 617 | ||||
Preclinical and clinical trials |
21,453 | 19,190 | ||||||
Other |
1,449 | 1,592 | ||||||
|
|
|
|
|||||
Total |
$ | 24,014 | $ | 21,399 | ||||
|
|
|
|
7. STOCKHOLDERS EQUITY
(a) Stock Purchase Rights
All shares of the Companys common stock, if issued prior to the termination by the Company of its rights agreement, dated as of December 4, 2006, include stock purchase rights. The rights are exercisable only if a person or group acquires twenty percent or more of the Companys common stock or announces a tender or exchange offer which would result in ownership of twenty percent or more of the Companys common stock. Following the acquisition of twenty percent or more of the Companys common stock, the holders of the rights, other than the acquiring person or group, may purchase Medivation common stock at half of its fair market value. In the event of a merger or other acquisition of the Company, the holders of the rights, other than the acquiring person or group, may purchase shares of the acquiring entity at half of their fair market value. The rights were not exercisable at December 31, 2011.
(b) Medivation Equity Incentive Plan
The Medivation Amended and Restated 2004 Equity Incentive Award Plan, or the Medivation Equity Incentive Plan, which is stockholder-approved, provides for the issuance of options and other stock-based awards, including restricted stock units, performance share awards and stock appreciation rights, covering up to 7,500,000 shares of Medivations common stock. Shares issued upon exercise of stock-based awards are new shares that have been reserved for issuance under the Medivation Equity Incentive Plan. The amendment and restatement of the Medivation Equity Incentive Plan was approved by the Companys Board of Directors, or Board, and by the Companys stockholders in March and May 2007, respectively.
The Medivation Equity Incentive Plan is administered by the Board, or a committee appointed by the Board, which determines recipients and types of awards to be granted, including the number of shares subject to the awards, the exercise price and the vesting schedule. The vesting of all outstanding awards under the Medivation Equity Incentive Plan, including all outstanding options, restricted stock units, performance share awards and stock appreciation rights will accelerate and become immediately exercisable upon a change of control of Medivation, as defined in the Medivation Equity Incentive Plan.
Stock options
The Company has granted stock options to employees, directors and consultants pursuant to the terms of the Medivation Equity Incentive Plan. The terms of stock options granted under the Medivation Equity Incentive Plan cannot exceed ten years. Options generally have an exercise price equal to the fair market value of the Companys common stock on the grant date, and generally vest over a period of four years.
The Company estimates the fair value of each option granted to employees and directors on the grant date using the Black-Scholes valuation model, which requires the use of subjective assumptions related to the expected stock price volatility, expected stock option term, expected dividend yield and expected risk-free rates
78
of return. The following table presents the assumptions used to estimate the fair value of employee and director stock options granted during the years ended December 31, 2011, 2010 and 2009. No significant option grants were made to consultants during the periods presented.
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Risk-free interest rate |
1.02-2.34% | 1.48-2.39% | 1.71-2.87% | |||||||||
Estimated term (in years) |
5.6-6.0 | 6.0 | 6.0 | |||||||||
Estimated volatility |
71-86% | 71-72% | 7288% | |||||||||
Estimated dividend yield |
None | None | None | |||||||||
Weighted-average grant-date fair value per share of options granted |
$ | 13.75 | $ | 9.64 | $ | 23.04 |
Beginning with the first quarter of 2011, the Company estimates volatility based on the historical price volatility of its common stock and implied volatility of its common stock inherent in the market price of publicly traded options in its common stock. For periods prior to the first quarter of 2011, the Company also considered the historical price volatility of comparable companies common stock.
Prior to the first quarter of 2010, due to its limited history of stock option exercise behavior, the Company used the simplified method of estimating stock option term provided for in SAB No. 107 and No. 110 for options granted to employees and directors. Beginning in the first quarter of 2010, the Company changed to a method based on its actual exercise experience and an assumption that unexercised options will remain outstanding for a period equal to the midpoint between the date the option vests in full and the contractual option termination date.
The Company has no history or expectation of paying cash dividends on its common stock. The risk-free interest rate is based on the U.S. Treasury yield for a term consistent with the expected term of the awards at the time of grant.
The use of different estimates of expected stock price volatility, expected stock option term, expected dividend yield and risk-free interest rates could materially change the fair value of an option and the resulting non-cash compensation expense.
The following table summarizes stock option activity during the year ended December 31, 2011:
Number of Shares |
Weighted- Average Exercise Price |
Weighted- Average Remaining Contractual Term (in years) |
Aggregate Intrinsic Value (1) |
|||||||||||||
Options outstanding at December 31, 2010 |
5,041,303 | $ | 17.39 | |||||||||||||
Granted |
595,364 | $ | 19.71 | |||||||||||||
Exercised |
(1,106,403 | ) | $ | 14.22 | ||||||||||||
Forfeited |
(228,456 | ) | $ | 20.79 | ||||||||||||
|
|
|||||||||||||||
Options outstanding at December 31, 2011 |
4,301,808 | $ | 18.34 | 6.9 | $ | 119.4 | ||||||||||
|
|
|||||||||||||||
Vested and exercisable as of December 31, 2011 |
2,739,718 | $ | 16.72 | 5.9 | $ | 80.5 | ||||||||||
|
|
(1) | The aggregate intrinsic value is calculated as the pre-tax difference between the exercise price of the underlying awards and the closing stock price per share of $46.11 of the Companys common stock on December 30, 2011. The amount is presented in millions. |
79
Additional information regarding stock options is set forth below:
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Intrinsic value of options exercised |
$ | 22,238 | $ | 8,584 | $ | 6,208 | ||||||
Grant-date fair value of options vested |
$ | 12,608 | $ | 13,730 | $ | 11,653 |
Restricted Stock Units
The Company has granted restricted stock units to employees pursuant to the terms of the Medivation Equity Incentive Plan. A restricted stock unit award is an agreement to issue shares of the Companys common stock at the time of vesting. All restricted stock units granted to date by the Company vest in three equal installments on the first, second and third anniversaries of the grant date. The fair value of restricted stock units equals the closing market price of the Companys common stock on the grant date.
The following table summarizes restricted stock unit activity:
Number of Shares |
Weighted- Average Grant-Date Fair Value |
|||||||
Unvested at December 31, 2010 |
173,119 | $ | 14.23 | |||||
Vested |
(51,606 | ) | $ | 14.37 | ||||
Forfeited |
(19,896 | ) | $ | 13.29 | ||||
|
|
|||||||
Unvested at December 31, 2011 |
101,617 | $ | 14.35 | |||||
|
|
The total fair value of restricted stock units that vested during the years ended December 31, 2011, 2010 and 2009 were $2.4 million, $0.2 million and $0.4 million, respectively.
Performance Share Awards
The Company granted performance share awards in 2011 to certain employees pursuant to the terms of the Medivation Equity Incentive Plan. The terms of the performance share awards provide for base case and upside case numbers of shares eligible to be earned based on the level of achievement of specified performance objectives relating to commercial product sales and timelines.
The performance shares under the awards will be earned, if at all, upon determination by the Compensation Committee of the Board of Directors, or the Committee, of actual achievement of performance objectives, subject to specified change of control exceptions. Each recipient of a performance share award must remain an employee of the Company through the date the Committee determines actual performance has been achieved in order to earn the performance shares eligible under the award. Each performance share award is convertible into one share of the Companys common stock upon the achievement of the performance objective. The base and upside case numbers of shares eligible to be earned under the performance share awards are set forth below. The number of performance shares eligible to be earned at the upside case level is based on achievement of the applicable performance objectives by specified dates, and the number of performance shares eligible to be earned at the base case level is based on the achievement of the performance objectives during the ten year term of the performance share awards. The following summarizes the performance share awards outstanding at December 31, 2011:
Base Case Achievement | Upside Case Achievement | |||||||||||||||
Minimum | Maximum | Minimum | Maximum | |||||||||||||
Performance shares eligible to be earned |
10,419 | 31,254 | 20,834 | 62,500 |
80
Stock-based compensation expense associated with performance share awards is based on the estimated grant date fair value of the Companys common stock using the Black Scholes valuation model, and is recognized based on the probable outcome of the performance conditions, which are evaluated quarterly.
Stock Appreciation Rights
The Company granted stock appreciation rights in 2011 to certain employees pursuant to the terms of the Medivation Equity Incentive Plan. Stock appreciation rights give the holder the right, upon exercise, to receive the difference between the price per share of the Companys common stock at the time of exercise and the exercise price of the stock appreciation right. The exercise price of the stock appreciation rights is equal to the market price of the Companys common stock at the date of grant. One-fourth of the shares subject to the stock appreciation rights vest and become exercisable on the first anniversary of the grant date, and the remaining three-fourths of the shares vest monthly over the three years thereafter. The term of the stock appreciation rights is ten years.
Until such time, if any, that the Companys stockholders approve an increase to the number of shares of common stock available pursuant to the Medivation Equity Incentive Plan, the stock appreciation rights may be settled only in cash; following such approval, if it occurs, the stock appreciation rights may be settled only in the Companys common stock.
The Company estimates the fair value of each stock appreciation right on the grant date using the Black-Scholes valuation model. The following grant date assumptions were used to estimate the fair value of stock appreciation rights granted during the year ended December 31, 2011:
Risk-free interest rate |
1.07 | % | ||
Estimated term (in years) |
5.6 | |||
Estimated volatility |
71 | % | ||
Estimated dividend yield |
None | |||
Weighted-average grant-date fair value per share of stock appreciation rights granted |
$ | 29.81 |
The stock appreciation rights are currently liability-classified awards for which compensation expense and the liability are remeasured at each reporting date through the date of settlement based on the portion of the requisite service period rendered. At December 31, 2011, 262,800 stock appreciation rights were outstanding, none of which were exercisable.
Warrants
At December 31, 2011, warrants to purchase an aggregate of 22,904 shares of Medivation common stock at a weighted-average exercise price of $6.92 per share were outstanding. These outstanding warrants expire between 2014 and 2017.
Stock-Based Compensation
Stock-based compensation expense was as follows:
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Stock-based compensation expense recognized as: |
||||||||||||
Research and development expense |
$ | 5,795 | $ | 7,629 | $ | 5,664 | ||||||
Selling, general and administrative expense |
8,090 | 5,901 | 5,062 | |||||||||
|
|
|
|
|
|
|||||||
Total |
$ | 13,885 | $ | 13,530 | $ | 10,726 | ||||||
|
|
|
|
|
|
81
The Company applies a forfeiture rate when determining non-cash stock-based compensation expense to account for an estimate of the granted awards not expected to vest. If actual forfeitures differ from the expected rate, the Company may be required to make additional adjustments to compensation expense in future periods. At December 31, 2011, the unrecognized stock-based compensation expense related to awards granted under the Medivation Equity Incentive Plan totaled $27.7 million, which is expected to be recognized as non-cash compensation expense over a weighted-average period of 2.68 years.
8. RETIREMENT PLAN
The Company has a defined contribution savings plan, which qualifies as a deferred salary arrangement under Section 401(k) of the Internal Revenue Code, or IRC. The 401(k) Plan is for the benefit of all employees and permits voluntary contributions by employees up to 100% of their annual pretax compensation limited by the Internal Revenue Service, or the IRS, imposed maximum contribution. The Company matches 100% of the first 3% of employee contributions and 50% of the next 2% of employee contributions. The Companys contributions and the employee contributions are fully vested when contributed. The plan assets are held in trust and invested as directed by the plan participants. Employer matching contributions to the plan were $0.6 million, $0.5 million and $0.4 million for the years ended December 31, 2011, 2010 and 2009, respectively.
9. INCOME TAXES
The Companys pre-tax loss for financial statement purposes was $43.2 million, $32.5 million and $46.5 million for the years ended December 31, 2011, 2010 and 2009, respectively. The income tax (benefit) expense consisted of the following:
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Current: |
||||||||||||
Federal |
$ | (4,309 | ) | $ | 5,012 | $ | 441 | |||||
State |
(22 | ) | (3,440 | ) | 7,831 | |||||||
|
|
|
|
|
|
|||||||
Total current |
(4,331 | ) | 1,572 | 8,272 | ||||||||
Deferred: |
||||||||||||
Federal |
| | | |||||||||
State |
| | | |||||||||
|
|
|
|
|
|
|||||||
Total deferred |
| | | |||||||||
|
|
|
|
|
|
|||||||
Total income tax (benefit) expense |
$ | (4,331 | ) | $ | 1,572 | $ | 8,272 | |||||
|
|
|
|
|
|
A reconciliation of the statutory Federal income tax rate of 35% to the Companys effective income tax rates is as follows:
Years Ended December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Federal tax provision at statutory rate |
35.00 | % | 35.00 | % | 35.00 | % | ||||||
State taxes (net of Federal benefit) |
2.27 | % | (4.17 | %) | 6.91 | % | ||||||
Change in reserve |
(0.94 | %) | (1.84 | %) | | |||||||
Orphan drug credit |
(0.70 | %) | (1.06 | %) | | |||||||
Stock-based compensation |
0.06 | % | (2.03 | %) | (1.26 | %) | ||||||
Change in valuation allowance |
(29.94 | %) | (39.65 | %) | (66.60 | %) | ||||||
Research and development credits |
7.05 | % | 9.72 | % | 6.54 | % | ||||||
Net proceeds from stockholder securities law settlement |
(2.43 | %) | | | ||||||||
Other |
(0.33 | %) | (0.81 | %) | 1.52 | % | ||||||
|
|
|
|
|
|
|||||||
Benefit (provision) for taxes |
10.04 | % | (4.84 | %) | (17.89 | %) | ||||||
|
|
|
|
|
|
82
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the tax basis of assets and liabilities. Significant components of the Companys deferred tax assets for Federal and state income taxes are follows:
December 31, | ||||||||
2011 | 2010 | |||||||
Deferred tax assets: |
||||||||
Deferred revenue |
$ | 54,116 | $ | 76,638 | ||||
Net operating loss carry forward |
30,767 | 4,786 | ||||||
Stock-based compensation |
9,872 | 8,243 | ||||||
Research and development credits |
11,280 | 3,280 | ||||||
Depreciation, amortization and other |
133 | 120 | ||||||
Accruals and reserves |
552 | 729 | ||||||
|
|
|
|
|||||
Total deferred tax assets |
106,720 | 93,796 | ||||||
Less: valuation allowance |
(106,720 | ) | (93,796 | ) | ||||
|
|
|
|
|||||
Net deferred tax assets |
$ | | $ | | ||||
|
|
|
|
The income tax benefit for 2011 was approximately $4.3 million, which represents an effective tax rate of 10.04%. The income tax benefit mainly consists of a benefit due to the ability to carry back the current year Federal net operating loss to the prior two tax years. The difference in the effective tax rate for 2011 as compared to 2010 is primarily attributable to the benefit in 2011 due to the ability to carry back the current year Federal net operating loss to the prior two tax years.
The income tax provision for 2010 was approximately $1.6 million, which mainly consists of the Federal and state income tax and represents an effective tax rate of (4.84)%. The decrease in the effective tax rate in 2010 as compared to 2009 was primarily attributable to the state tax benefit recognized in 2010 from the 2009 California income tax refund.
During the year ended December 31, 2010, the Company accelerated the recognition of revenue related to the Astellas non-refundable, up-front payment received in 2009 for income tax purposes, while such revenue was deferred for financial statement purposes. The Company also accelerated the recognition of the milestone payment of $10.0 million received in October 2010 from Astellas for income tax purposes, while such revenue was deferred for financial statement purposes. Due to the suspension of California Net Operating Loss utilization in 2010, the Company was not able to utilize the net operating loss carryforwards to offset the taxable income in 2010.
Due to the Companys lack of earnings history, the net deferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by $12.9 million, $12.9 million and $30.8 million during the years ended December 31, 2011, 2010 and 2009, respectively.
The following table summarizes activity related to the Companys gross unrecognized tax positions:
December 31, | ||||||||||||
2011 | 2010 | 2009 | ||||||||||
Balance as of beginning of year |
$ | 4,128 | $ | 889 | $ | 358 | ||||||
Additions based on tax positions related to the current year |
500 | 393 | 429 | |||||||||
Additions based on tax position related to prior year |
109 | 2,846 | 102 | |||||||||
Decreases based on tax positions related to prior year |
(801 | ) | | | ||||||||
|
|
|
|
|
|
|||||||
Balance as of end of year |
$ | 3,936 | $ | 4,128 | $ | 889 | ||||||
|
|
|
|
|
|
83
Approximately $0.6 million and $1.2 million of the total gross unrecognized tax benefits at December 31, 2011 and 2010, respectively, if recognized, would affect the effective tax rate. The Company does not anticipate a material change in unrecognized tax benefits during the next 12 months.
As a result of the Companys net operating loss carryforwards, all of its tax years are subject to Federal and state examination. At December 31, 2011, there are no Federal or state tax audits in process. The Company was under audit by the Internal Revenue Service, or IRS, for the tax year of 2008. The audit was closed in 2011 with no adjustment.
Federal and state tax laws impose substantial restrictions on the utilization of net operating loss and credit carryforwards in the event of an ownership change for tax purposes, as defined in Internal Revenue Code Section 382. The Company completed Section 382 studies through December 31, 2010, and concluded that ownership changes occurred in 2004, 2007 and 2010. The ownership changes did not result in a reduction of its net operating loss or in its research and development credits expiring unused. If additional ownership change occurs, the utilization of net operating loss and credit carryforwards could be significantly reduced.
As of December 31, 2011, the Company has Federal net operating loss carryforwards of approximately $77.3 million, which will expire in 2031, if not utilized. Also, as of December 31, 2011, the Company has state net operating loss carryforwards of approximately $154.1 million, which will expire at various dates between the years 2015 and 2031, if not utilized.
The Company has Federal research and development credit and Orphan Drug credit carryforwards of approximately $13.3 million as of December 31, 2011. The Federal tax credit carryforwards expire in the year 2024 through 2031, if not used. In addition, the Company has California research and development credit carryforwards of approximately $1.4 million as of December 31, 2011. The California research credits do not expire.
10. FAIR VALUE MEASUREMENTS
The Company follows ASC 820-10, Fair Value Measurements and Disclosures, which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:
| Level 1Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. |
| Level 2Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instruments anticipated life. |
| Level 3Inputs reflect managements best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. |
84
At December 31, 2011 and 2010, the Company did not have any assets or liabilities classified as Level 2 or Level 3. Assets classified as Level 1 are included in the table below:
Fair value measurements using: | ||||||||||||||||
Fair Value | Level 1 | Level 2 | Level 3 | |||||||||||||
December 31, 2011: |
||||||||||||||||
Cash and cash equivalents: |
||||||||||||||||
Money market funds |
$ | 44,044 | $ | 44,044 | | | ||||||||||
Short-term investments: |
||||||||||||||||
U.S. Treasury bills |
$ | 74,996 | $ | 74,996 | | | ||||||||||
December 31, 2010: |
||||||||||||||||
Cash and cash equivalents: |
||||||||||||||||
Money market funds |
$ | 53,657 | $ | 53,657 | | | ||||||||||
Short-term investments: |
||||||||||||||||
U.S. Treasury note |
$ | 99,964 | $ | 99,964 | | |
11. COMMITMENTS AND CONTINGENCIES
(a) Operating Leases
The majority of the Companys operating lease payments relate to its corporate headquarters. The Companys corporate headquarters are located at 201 Spear Street, San Francisco, California, where it leases approximately 34,000 square feet of office space pursuant to lease agreements that expire in July 2012 and May 2013.
In December 2011, the Company entered into a lease agreement for approximately 57,000 square feet of office space located at 525 Market Street, San Francisco, California, which is intended to serve as its future corporate headquarters following construction and build-out. The term of the lease is for seven years, with an anticipated commencement date of June 2012. The Company has an option to extend the term of the lease for an additional five years.
The future minimum rentals under the Companys non-cancelable operating leases having initial or remaining terms in excess of one year at December 31, 2011 were as follows:
2012 |
$ | 3,599 | ||
2013 |
4,814 | |||
2014 |
4,563 | |||
2015 |
4,620 | |||
2016 and after |
11,206 | |||
|
|
|||
Total |
$ | 28,802 | ||
|
|
Rent expense, net of sublease income, for the years ended December 31, 2011, 2010 and 2009 was $2.8 million, $2.2 million and $2.8 million, respectively. Sublease income was not significant for the periods presented. In addition to the future minimum rental payments included in the table above, certain lease agreements also require the Company to make additional payments during the lease term for taxes, insurance, and other operating expenses.
In March 2010, the Company terminated a lease for approximately 64,000 square feet of office space located at 345 Spear Street, San Francisco, California, that it entered into in November 2009, which was intended to serve as the Companys corporate headquarters. The lease, which was terminated as a result of the negative CONNECTION trial results, resulted in a termination fee of $1.5 million, of which half was recorded as expense in the fourth quarter of 2009 and the remaining half was recorded as expense in the first quarter of 2010.
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(b) Restricted Cash
The Company has outstanding letters of credit collateralized by restricted cash totaling $6.0 million and $0.8 million at December 31, 2011 and 2010, respectively, to secure various operating leases. At December 31, 2011, $0.5 million and $5.5 million of restricted cash associated with these letters of credit were classified as current and long-term assets, respectively, on the consolidated balance sheets, and at December 31, 2010, $0.8 million of restricted cash was classified as long-term assets.
(c) Litigation
In March 2010, the first of several putative securities class action lawsuits was commenced in the U.S. District Court for the Northern District of California, naming as defendants the Company and certain of its officers. The lawsuits are largely identical and allege violations of the Securities Exchange Act of 1934, as amended. The plaintiffs allege, among other things, that the defendants disseminated false and misleading statements about the effectiveness of dimebon for the treatment of Alzheimers disease. The plaintiffs purport to seek damages, an award of their costs and injunctive relief on behalf of a class of stockholders who purchased or otherwise acquired common stock in the Company between September 21, 2006 and March 2, 2010. The actions were consolidated in September 2010 and in April 2011 the court entered an order appointing Catoosa Fund L.P. and its attorneys as lead plaintiff and lead counsel. Thereafter, the lead plaintiff filed a consolidated, amended complaint, which was dismissed without prejudice as to all defendants in August 2011. The lead plaintiff filed a second amended complaint in November 2011. In January 2012, the Company filed a motion to dismiss the second amended complaint, which is scheduled to be heard by the Court on March 16, 2012. This lawsuit is subject to inherent uncertainties, and the actual cost will depend upon many unknown factors. The outcome of the litigation is necessarily uncertain, and the Company could be forced to expend significant resources in the defense of the suit and it may not prevail. The Company has not established any reserve for any potential liability relating to this lawsuit. The Companys management believes that the Company has meritorious defenses and intends to defend the lawsuit vigorously. The Company believes it is entitled to coverage under its relevant insurance policies, subject to a $350,000 retention, but coverage could be denied or prove to be insufficient.
12. RESTRUCTURING
In response to the negative CONNECTION trial data, the Company implemented a restructuring in March 2010 in which it eliminated 23 full-time positions and vacated approximately 3,700 square feet of office space. Terminated individuals were eligible for a package consisting of a severance payment, continuing medical coverage and outplacement services. The Company recorded restructuring charges totaling $0.9 million during the first quarter of 2010, of which $0.4 million was classified as selling, general and administrative expense and $0.5 million was classified as research and development expense. No amounts related to the restructuring were recorded in 2011.
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13. SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)
The following table presents the unaudited quarterly results of operations of the Company for the years ended December 31, 2011 and 2010, respectively. The unaudited information is prepared on the same basis as the audited consolidated financial statements. The Companys operating results for any quarter are not necessarily indicative of results for any future quarters or for a full year.
Quarters Ended | ||||||||||||||||
March 31, | June 30, | September 30, | December 31, | |||||||||||||
2011: |
||||||||||||||||
Collaboration revenue |
$ | 14,709 | $ | 15,799 | $ | 14,940 | $ | 14,941 | ||||||||
Operating expenses |
$ | (23,774 | ) | $ | (26,175 | ) | $ | (26,430 | ) | $ | (26,940 | ) | ||||
Loss from operations |
$ | (9,065 | ) | $ | (10,376 | ) | $ | (11,490 | ) | $ | (11,999 | ) | ||||
Net loss |
$ | (8,452 | ) | $ | (9,474 | ) | $ | (10,044 | ) | $ | (10,871 | ) | ||||
Basic and diluted net loss per common share |
$ | (0.24 | ) | $ | (0.27 | ) | $ | (0.29 | ) | $ | (0.31 | ) | ||||
Weighted-average common shares used in the calculation of basic and diluted net loss per common share |
34,663 | 34,888 | 34,909 | 35,375 | ||||||||||||
2010: |
||||||||||||||||
Collaboration revenue |
$ | 15,734 | $ | 15,792 | $ | 14,350 | $ | 16,632 | ||||||||
Operating expenses |
$ | (33,421 | ) | $ | (23,229 | ) | $ | (21,087 | ) | $ | (17,496 | ) | ||||
Loss from operations |
$ | (17,687 | ) | $ | (7,437 | ) | $ | (6,737 | ) | $ | (864 | ) | ||||
Net loss |
$ | (17,465 | ) | $ | (7,240 | ) | $ | (5,443 | ) | $ | (3,889 | ) | ||||
Basic and diluted net loss per common share |
$ | (0.51 | ) | $ | (0.21 | ) | $ | (0.16 | ) | $ | (0.11 | ) | ||||
Weighted-average common shares used in the calculation of basic and diluted net loss per common share |
33,953 | 34,053 | 34,570 | 34,573 |
14. SUBSEQUENT EVENTS
(a) Termination of Pfizer Collaboration Agreement and Dimebon Program
In January 2012, the Company reported negative top line results from its Phase 3 CONCERT trial of dimebon in patients with mild-to-moderate Alzheimers disease. The Company previously had reported negative top line results from its Phase 3 CONNECTION trial of dimebon in patients with mild-to-moderate Alzheimers disease and its Phase 3 HORIZON trial of dimebon in patients with Huntington disease. In January 2012, Pfizer exercised its right to terminate the collaboration agreement and the Company and Pfizer discontinued development of dimebon for all indications. During the ensuing 180 days, the Company and Pfizer will work together to wind down their remaining collaboration activities.
The Company estimates that it and Pfizer will complete their collaboration wind down activities in the first half of 2012. Thus, during the first quarter of 2012 the Company revised its estimate of the remaining performance period under its former collaboration agreement with Pfizer. The Company expects the performance period to conclude in the first half of 2012. The remaining deferred revenue balance relating to the former collaboration agreement with Pfizer, which totaled $72.0 million at December 31, 2011, will be recognized as revenue over the remaining performance period.
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(b) Oakbrook Terrace Lease
In February 2012, the Company entered into a lease agreement for 15,336 square feet of office space located in Oakbrook Terrace, Illinois, which is intended to serve as its commercial headquarters following construction and build-out. The term of the lease is seven years and seven months, with an anticipated commencement date of May 2012. The Company selected this location for its commercial headquarters based on its proximity to the Companys collaboration partner, Astellas. The annual non-cancelable rent payments are approximately $0.3 million per year. In connection with the execution of the lease, the Company delivered to the lessor a letter of credit collateralized by restricted cash totaling $0.8 million.
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Exhibit Index
Incorporated By Reference | ||||||||||||||||||||
Exhibit |
Exhibit Description |
Form | File No. | Exhibit | Filing Date | Filed Herewith | ||||||||||||||
3.1 | Amended and Restated Certificate of Incorporation. | 10-QSB | 000-20837 | 3.1 | (a) | 8/15/2005 | ||||||||||||||
3.2 | Certificate of Amendment of Amended and Restated Certificate of Incorporation. | 10-QSB | 000-20837 | 3.1 | (b) | 8/15/2005 | ||||||||||||||
3.3 | Certificate of Amendment to the Amended and Restated Certificate of Incorporation. | 10-QSB | 000-20837 | 3.1 | (c) | 8/15/2005 | ||||||||||||||
3.4 | Certificate of Designations of the Series C Junior Participating Preferred Stock of Medivation, Inc. | 10-KSB | 001-32836 | 3.1 | (d) | 2/19/2008 | ||||||||||||||
3.5 | Amended and Restated Bylaws of Medivation, Inc. | 10-K | 001-32836 | 3.2 | 3/16/2009 | |||||||||||||||
4.1 | Common Stock Certificate. | SB-2/A | 333-03252 | 4.1 | 6/14/1996 | |||||||||||||||
4.2 | Rights Agreement, dated as of December 4, 2006, between Medivation, Inc. and American Stock Transfer & Trust Company, as Rights Agent, which includes the form of Certificate of Designations of the Series C Junior Participating Preferred Stock of Medivation, Inc. as Exhibit A, the form of Right Certificate as Exhibit B and the Summary of Rights to Purchase Preferred Shares as Exhibit C. | 8-K | 001-32836 | 4.1 | 12/4/2006 | |||||||||||||||
10.1 | Warrant to purchase Common Stock of Medivation Neurology, Inc. assumed by Orion Acquisition Corp. II issued to Joseph J. Grano, Jr., dated as of June 8, 2004. | SB-2 | 333-122431 | 10.5 | (a) | 1/31/2005 | ||||||||||||||
10.2* | Warrant to purchase Common Stock of Medivation Neurology, Inc. assumed by Orion Acquisition Corp. II issued to David T. Hung, M.D., dated as of November 16, 2004. | SB-2 | 333-122431 | 10.6 | 1/31/2005 | |||||||||||||||
10.3* | Amended and Restated 2004 Equity Incentive Award Plan. | 10-KSB | 001-32836 | 10.4 | (a) | 2/19/2008 | ||||||||||||||
10.4* | Form of Stock Option Agreement under the 2004 Equity Incentive Award Plan. | 10-KSB | 000-20837 | 10.7 | (b) | 2/11/2005 | ||||||||||||||
10.5* | Form of Stock Option Agreement for Early Exercisable Options under the 2004 Equity Incentive Award Plan. | 10-KSB | 000-20837 | 10.7 | (c) | 2/11/2005 |
Incorporated By Reference | ||||||||||||||||||||||
Exhibit |
Exhibit Description |
Form | File No. | Exhibit | Filing Date | Filed Herewith |
||||||||||||||||
10.6** | Amended and Restated Collaboration Agreement, dated as of October 20, 2008, between Medivation, Inc. and Pfizer Inc. | 10-Q | 001-32836 | 10.8 | 11/10/2008 | |||||||||||||||||
10.7* | Change of Control Severance Benefits Agreement, dated as of February 2, 2009, between Medivation, Inc. and David Hung, M.D. | 10-K | 001-32836 | 10.11 | 3/16/2009 | |||||||||||||||||
10.8* | Form of Medivation, Inc. Change of Control Severance Benefits Agreement. | 10-K | 001-32836 | 10.13 | 3/16/2009 | |||||||||||||||||
10.9** | Collaboration Agreement, dated as of October 26, 2009, by and between Medivation, Inc. and Astellas US LLC. | 10-K | 001-32836 | 10.15 | 3/15/2010 | |||||||||||||||||
10.10** | Amendment No. 1 to Collaboration Agreement, dated January 1, 2010, by and among Medivation, Inc., Astellas Pharma Inc. and Astellas US LLC | 10-Q | 001-32836 | 10.1 | 8/9/2011 | |||||||||||||||||
10.11** | Amendment No. 2 to Collaboration Agreement, dated May 13, 2011, by and among Medivation, Inc., Astellas Pharma Inc. and Astellas US LLC | 10-Q | 001-32836 | 10.2 | 8/9/2011 | |||||||||||||||||
10.12 | Office Lease Agreement, dated as of November 2, 2009, by and between Medivation, Inc. and PPF OFF 345 Spear Street, LP. | 10-K | 001-32836 | 10.16 | 3/15/2010 | |||||||||||||||||
10.13* | Compensation Information for Non-Employee Directors. | X | ||||||||||||||||||||
10.14** | Exclusive License Agreement, dated as of August 12, 2005, as amended through October 21, 2009, by and between Medivation, Inc. and The Regents of the University of California. | 10-Q/A | 001-32836 | 10.18 | 8/20/2010 | |||||||||||||||||
10.15 | Office Lease, dated April 18, 2007, by and between CREA Spear Street Terrace LLC and Medivation, Inc. | 10-K | 001-32836 | 10.16 | 3/16/2011 | |||||||||||||||||
10.16 | Sublease, dated November 10, 2008, by and between MacFarlane Partners Investment Management, LLC and Medivation, Inc. | 10-K | 001-32836 | 10.17 | 3/16/2011 | |||||||||||||||||
10.17 | First Amendment to Lease, dated September 16, 2009, by and between CREA Spear Street Terrace LLC and Medivation, Inc. | 10-K | 001-32836 | 10.18 | 3/16/2011 |
Incorporated By Reference | ||||||||||||||||||||||
Exhibit |
Exhibit Description |
Form | File No. | Exhibit | Filing Date | Filed Herewith |
||||||||||||||||
10.18 | Second Amendment to Lease, dated November 30, 2010, by and between CREA Spear Street Terrace LLC and Medivation, Inc. | 10-K | 001-32836 | 10.19 | 3/16/2011 | |||||||||||||||||
10.19* | Bonuses for Fiscal Year 2010 and Base Salaries for Fiscal Year 2011 for Certain Executive Officers. | 10-K | 001-32836 | 10.20 | 3/16/2011 | |||||||||||||||||
10.20* | Medivation, Inc. 2011 Bonus Plan Summary. | 10-K | 001-32836 | 10.21 | 3/16/2011 | |||||||||||||||||
10.21* | Form of Restricted Stock Unit Grant Notice and Agreement under the 2004 Equity Incentive Award Plan. | 10-K | 001-32836 | 10.22 | 3/16/2011 | |||||||||||||||||
10.22* | Separation Agreement, dated as of September 21, 2011, between Medivation, Inc. and Rohan Palekar. | 8-K | 001-32836 | 10.1 | 9/27/2011 | |||||||||||||||||
10.23* | Bonuses for Fiscal Year 2011 and Base Salaries for Fiscal Year 2012 for Certain Executive Officers | 8-K | 001-32836 | 10.1 | 12/15/2011 | |||||||||||||||||
10.24* | Medivation, Inc. 2012 Bonus Plan Summary | 8-K | 001-32836 | 10.2 | 12/15/2011 | |||||||||||||||||
10.25* | Form of Indemnification Agreement for directors and officers | X | ||||||||||||||||||||
10.26* | Offer Letter, dated August 31, 2011, by and between Medivation, Inc. and Cheryl Cohen. |
X | ||||||||||||||||||||
10.27 | Office Lease, dated as of December 28, 2011, by and between Knickerbocker Properties, Inc. XXXIII and Medivation, Inc. | X | ||||||||||||||||||||
10.28* | Form of Stock Appreciation Right Grant Notice and Agreement under the 2004 Equity Incentive Award Plan | X | ||||||||||||||||||||
10.29* | Form of Performance Share Award Grant Notice and Agreement under the 2004 Equity Incentive Award Plan | X | ||||||||||||||||||||
21.1 | Subsidiaries of Medivation, Inc. | X | ||||||||||||||||||||
23.1 | Consent of Independent Registered Public Accounting Firm. | X | ||||||||||||||||||||
24.1 | Power of Attorney (contained on signature page). | X | ||||||||||||||||||||
31.1 | Certification pursuant to Rule 13a-14(a)/15d-14(a). | X | ||||||||||||||||||||
31.2 | Certification pursuant to Rule 13a-14(a)/15d-14(a). | X |
Incorporated By Reference | ||||||||||||||
Exhibit |
Exhibit Description |
Form | File No. | Exhibit | Filing Date | Filed Herewith |
||||||||
32.1 | Certifications of Chief Executive Officer and Chief Financial Officer. | X | ||||||||||||
101.INS# | XBRL Instance Document. | X | ||||||||||||
101.SCH# | XBRL Taxonomy Extension Schema Document. | X | ||||||||||||
101.CAL# | XBRL Taxonomy Extension Calculation Linkbase Document | X | ||||||||||||
101.DEF# | XBRL Taxonomy Extension Definition Linkbase Document | X | ||||||||||||
101.LAB# | XBRL Taxonomy Extension Labels Linkbase Document | X | ||||||||||||
101.PRE# | XBRL Taxonomy Extension Presentation Linkbase Document | X |
* | Indicates management contract or compensatory plan or arrangement. |
** | Confidential treatment has been granted with respect to certain portions of this exhibit. |
| The certifications attached as Exhibit 32.1 accompany this Annual Report on Form 10-K, are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Medivation, Inc., under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation language contained in such filing. |
# | Pursuant to applicable securities laws and regulations, the Registrant is deemed to have complied with the reporting obligation related to the submission of interactive data files in such exhibits and is not subject to liability under any anti-fraud provisions of the federal securities laws as long as the Registrant has made a good faith attempt to comply with the submission requirements and promptly amends the interactive data files after becoming aware that the interactive data files fails to comply with the submission requirements. These interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act, are deemed not filed for the purposes of section 18 of the Exchange Act and otherwise are not subject to liability under those sections. |
Exhibit 10.13
COMPENSATION INFORMATION FOR NON-EMPLOYEE DIRECTORS
Medivation, Inc.
Cash Compensation for Non-Employee Directors
Annual Retainer, all members |
$35,000 | |
Annual Retainer for Chairman |
$30,000 | |
Annual Retainer for Committee Chairs: |
||
Audit Committee |
$15,000 | |
Compensation Committee |
$10,000 | |
Nominating and Corporate Governance Committee |
$7,500 | |
Annual Retainer for Committee Members: |
||
Audit Committee |
$5,000 | |
Compensation Committee |
$3,000 | |
Nominating and Corporate Governance Committee |
$2,500 | |
Fee per Board Meeting: |
||
Attended in Person |
$2,000 | |
Attended Telephonically |
$1,000 | |
Fee per Committee Meeting: |
||
Attended in Person |
$1,000 | |
Attended Telephonically |
$500 |
Medivation, Inc.
Equity Compensation for Non-Employee Directors
Upon initial election to the Board of Directors, each non-employee director receives an initial grant of an option to purchase 30,000 shares of the Companys common stock. Each non-employee director receives an annual grant of an option to purchase 7,500 shares of the Companys Common Stock at the next available date of grant pursuant to the Companys Stock Option Grant Date Policy following the Annual Meeting of Stockholders for the applicable year.
Exhibit 10.25
INDEMNIFICATION AGREEMENT
This Indemnification Agreement (Agreement) is made as of (the Effective Date) by and between Medivation, Inc., a Delaware corporation (the Company), and , who serves as a director and/or an officer of the Company (Indemnitee).
RECITALS
WHEREAS, highly competent persons have become more reluctant to serve corporations unless they are provided with adequate protection through insurance and/or indemnification against the risks of claims being asserted against them arising out of their service to and activities on behalf of such corporations; and
WHEREAS, the Board of Directors of the Company (the Board) has determined that the increased difficulty in attracting and retaining such persons is detrimental to the best interests of the Companys investors and that the Company should act to assure such persons that there will be increased certainty of such protection in the future; and
WHEREAS, the Board has determined that, in order to help attract and retain qualified individuals as directors and officers, the best interests of the Company and its investors will be served by attempting to maintain, on an ongoing basis, at the Companys sole expense, insurance to protect persons serving the Company and its subsidiaries as directors, officers and in other capacities from certain liabilities. Although the furnishing of such insurance has been a customary and widespread practice among United States-based corporations and other business enterprises for many years, the Company believes that, given current market conditions and trends, such insurance may be available to it in the future only at higher premiums and with more exclusions. At the same time, directors and officers, in service to corporations or business enterprises are being increasingly subjected to expensive and time-consuming litigation; and
WHEREAS, the Board has determined that, in order to help attract and retain qualified individuals as directors, officers and in other capacities, the best interests of the Company and its investors will be served by assuring such individuals that the Company will indemnify them to the maximum extent permitted by law; and
WHEREAS, the Amended and Restated Certificate of Incorporation (the Certificate of Incorporation) and the By-Laws (the By-Laws) of the Company require indemnification of the officers and directors of the Company, and Indemnitee may also be entitled to indemnification pursuant to the Delaware General Corporation Law (DGCL); and
WHEREAS, the Certificate of Incorporation, the By-Laws and the DGCL expressly provide that the indemnification provisions set forth therein are not exclusive, and thereby contemplate that contracts may be entered into between the Company and members of the Board with respect to indemnification and the advancement of defense costs; and
WHEREAS, it therefore is reasonable, prudent and necessary for the Company contractually to obligate itself to indemnify, and to advance defense costs on behalf of, such persons to the fullest extent permitted by applicable law so that they will serve or continue to serve the Company free from undue concern that they will not be so indemnified; and
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WHEREAS, this Agreement is a supplement to and in furtherance of the Certificate of Incorporation, By-Laws and any resolutions adopted pursuant thereto, and shall not be deemed a substitute therefor, nor shall it be deemed to diminish or abrogate any rights of Indemitee thereunder; and
WHEREAS, the Board recognizes that the Indemnitee does not regard the protection available under the Companys Certificate of Incorporation, the By-Laws and insurance program as adequate in the present circumstances, and may not be willing to serve or continue to serve as a director, officer and/or in such other capacity as the Company may request without adequate protection, and the Company desires Indemnitee to serve in such capacity; and
WHEREAS, Indemnitee is willing to serve, and continue to serve, as a member of the Board of Directors (and any committee thereof) and/or an officer of the Company, on the condition that he or she be indemnified as provided for herein.
NOW, THEREFORE, in consideration of the premises and the covenants contained herein, the Company and Indemnitee do hereby covenant and agree as follows:
l. Services to the Company. Indemnitee will serve or continue to serve, at the will of the Company, a director or officer of the Company for so long as Indemnitee is duly elected or appointed or until Indemnitee tenders his or her resignation. This Agreement shall not serve as a binding commitment on the part of Indemnitee to continue to serve in such capacity, or on the part of the Company to cause him to continue as such.
2. Definitions. As used in this Agreement:
(a) A Change in Control shall be deemed to occur upon the earliest to occur after the date of this Agreement of any of the following events:
(i) Any Person (excluding any employee benefit plan of the Company or any subsidiary of the Company) is or becomes the Beneficial Owner, directly or indirectly, of securities of the Company representing fifty percent (50%) or more of the combined voting power of the Companys outstanding securities then entitled ordinarily to vote for the election of directors; or
(ii) During any period of two (2) consecutive years commencing on or after the Effective Date, the individuals who at the beginning of such period constitute the Board or any individuals who would be Continuing Directors (as defined below) cease for any reason to constitute at least a majority thereof; or
(iii) The Board shall approve a sale of all or substantially all of the assets of the Company; or
(iv) The Board shall approve any merger, consolidation, or like business combination or reorganization of the Company, the consummation of which would result in the occurrence of any event described in clause (i) or (ii), above.
2
(b) Continuing Directors shall mean the directors of the Company in office on the Effective Date and any successor to any such director and any additional director who after the Effective Date (i) was nominated or selected by a majority of the Continuing Directors in office at the time of his or her nomination or selection and (ii) who is not an affiliate or associate (as defined in Regulation 12B promulgated under the Exchange Act) of any person who is the beneficial owner, directly or indirectly, of securities representing ten percent (10%) or more of the combined voting power of the Companys outstanding securities then entitled ordinarily to vote for the election of directors.
(c) Exchange Act shall mean the Securities Exchange Act of 1934, as amended.
(d) Person shall have the meaning set forth in Sections 13(d) and 14(d) of the Exchange Act; provided, however, that Person shall exclude (i) the Company and (ii) any trustee or other fiduciary holding securities under an employee benefit plan of the Company or a subsidiary of the Company.
(e) Beneficial Owner shall have the meaning given to such term in Rule 13d-3 issued under the Exchange Act; provided, however, that Beneficial Owner shall exclude any Person becoming a Beneficial Owner by reason of the stockholders of the Company approving a merger of the Company with another entity,
(f) Corporate Status shall describe the status of a person who is or was a director, officer, trustee, partner, member, fiduciary, employee or agent of the Company or of any other Enterprise (as defined below), which such person is or was serving at the request of the Company.
(g) Disinterested Director shall mean a director of the Company who is not and was not a party to the Proceeding (as defined below) in respect of which indemnification is sought by Indemmnitee.
(h) Enterprise shall mean any corporation, limited liability company, partnership, joint venture, trust, employee benefit plan or other enterprise of which Indemnitee is or was serving at the request of the Company as a director, officer, trustee, administrator, partner, member, fiduciary, employee or agent.
(i) Expenses shall include all reasonable attorneys fees, retainers, court costs, transcript costs, fees of experts and accountants, witness fees, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees, and all other disbursements or expenses of the types and amounts customarily incurred in connection with prosecuting, defending, preparing to prosecute or defend, investigating,
3
being or preparing to be a witness in, or otherwise participating in, a Proceeding (as defined below). Expenses also shall include costs incurred in connection with any appeal resulting from any Proceeding (as defined below), including, without limitation, the premium, security for, and other costs relating to any bond, supersedeas bond, or other appeal bond or its equivalent. Expenses, however, shall not include amounts paid in settlement by Indemnitee or the amount of .judgments or fines against Indemnitee.
G) References to fines shall include any excise tax assessed on a person with respect to any employee benefit plan pursuant to applicable law.
(k) References to serving at the request of the Company shall include any service provided at the request of the Company as a director, officer, trustee, administrator, partner, member, fiduciary, employee or agent of the Company which imposes duties on, or involves services by, such director, officer, trustee, administrator, partner, member, fiduciary, employee or agent with respect to an employee benefit plan, its participants or beneficiaries.
(1) Any action taken or omitted to be taken by a person for a purpose which he or she reasonably believed to be in the interests of the participants and beneficiaries of an employee benefit plan shall be deemed to have been taken in good faith and for a purpose which is not opposed to the best interests of the Company, as such terms are referred to in this Agreement and used in the DGCL.
(m) The term. Proceeding shall include any threatened, pending or completed action, suit, arbitration, alternate dispute resolution mechanism, investigation, inquiry, administrative hearing or any other actual, threatened or completed proceeding, whether brought in the right of the Company or otherwise and whether of a civil, criminal, administrative or investigative nature, including any related appeal, in which Indemnitee was, is or will be involved as a party or witness or otherwise by reason of the fact that Indemnitee is or was a director, officer, trustee, administrator, partner, member, fiduciary, employee or agent of the Company, by reason of any action taken or not taken by him or her while acting as director, officer, trustee, administrator, partner, member, fiduciary, employee or agent of the Company, or by reason of the fact that he or she is or was serving at the request of the Company as a director, officer, trustee, administrator, partner, member, fiduciary, employee or agent of any other Enterprise, in each case whether or not serving in such capacity at the time any liability or expense is incurred for which indemnification, reimbursement, or advancement of expenses can be provided under this Agreement.
(n) Independent Counsel means a law firm, or a member of a law firm, that is experienced in matters of corporation law and neither presently is, nor in the past five (5) years has been, retained to represent: (i) the Company or Indemnitee in any matter .material to either such party (other than with respect to matters concerning the Indemnitee under this Agreement, or other indemnitees under similar indemnification agreements), or (ii) any other party to the Proceeding giving rise to a claim for indemnification hereunder. Notwithstanding the foregoing, the term Independent Counsel shall not include any person who, under the applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the Company or Indernnitee in an action to determine Indenmitees rights under this Agreement.
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3. Indemnity in Third-Party Proceedings. The Company shall indemnify and hold harmless Indemnitee in accordance with the provisions of this Section 3 if Indemnitee is made, or is threatened to be made, a party to or a participant in (as a witness or otherwise) any Proceeding, other than a Proceeding by or in the right of the Company to procure a judgment in its favor. Pursuant to this Section 3, Indemnitee shall be indemnified and held harmless against all judgments, fines, penalties, amounts paid in settlement (if such settlement is approved in writing in advance by the Company, which approval shall not be unreasonably withheld) (including, without limitation, all interest, assessments and other charges paid or payable in connection with or in respect of any of the foregoing) (collectively, Losses) and Expenses actually and reasonably incurred by Indemnitee or on his or her behalf in connection with such Proceeding or any action, discovery event, claim, issue or matter therein or related thereto, if Indemnitee acted in good faith, for a purpose which he or she reasonably believed to be in or not opposed to the best interests of the Company and, in the case of a criminal Proceeding, in addition, had no reasonable cause to believe that his or her conduct was unlawful.
4. Indemnity in Proceedings by or in the Right of the Company, The Company shall indemnify Indemnitee in accordance with the provisions of this Section 4 if Indemnitee is made, or is threatened to be made, a party to or a participant in (as a witness or otherwise) any Proceeding by or in the right of the Company to procure a judgment in its favor. Pursuant to this Section 4, Indemnitee shall be indemnified and held harmless against all Expenses actually and reasonably incurred by him or her or on his or her behalf in connection with the defense or settlement of such Proceeding or any action, discovery event, claim, issue or matter therein or related thereto, if Indemnitee acted in good faith, for a purpose which he or she reasonably believed to be in or not opposed to the best interests of the Company. No indemnification, however, shall be made Colder this Section 4 in respect of any claim, issue or matter as to which Indemnitee shall have been adjudged to be liable to the Company, unless and only to the extent that the court in which the Proceeding was brought or, if no Proceeding was brought in a court, any court of competent jurisdiction, determines upon application that, in view of all the circumstances of the case, Indemnitee fairly and reasonably is entitled to indemnification for such portion of the Expenses as the court deems proper.
5. Indemnification for Expenses Where Indemnitee is Wholly or Partly Successful. Notwithstanding and in addition to any other provisions of this Agreement, to the extent that Indemnitee is a party to a Proceeding and is successful, on the merits or otherwise, in the defense of any claim, issue or matter therein, the Company shall indemnify and hold harmless Indemnitee against all Expenses actually and reasonably incurred by him or her or on his or her behalf in connection with such successful defense. For the avoidance of doubt, if Indemnitee is not wholly successful in such Proceeding but is successful, on the merits or otherwise, as to one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify Indemnitee against all Expenses actually and reasonably incurred by him or her or on his or her behalf in connection with each successfully resolved claim, issue or matter. For purposes of this Section 5 and, without limitation, the termination of any claim, issue or matter in such a Proceeding by withdrawal or dismissal, with or without prejudice, shall be deemed to be a successful result as to such claim, issue or matter.
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6. Indemnification for Expenses of a Witness. Notwithstanding and in addition to any other provision of this Agreement, to the extent that Indemnitee is, by reason of his or her Corporate Status, a witness in or otherwise incurs Expenses in connection with any Proceeding to which Indemnitee is not a party, he or she shall be indemnified and held harmless by the Company against all Expenses actually and reasonably incurred by him or her or on his or her behalf in connection therewith.
7. Additional Indemnification.
(a) Notwithstanding any limitation in Sections 3, 4, or 5 .hereof or in Section 145 of the DGCL or other applicable statutory provision, the Company and the shall indemnify Indemnitee to the fullest extent permitted by law if Indemnitee is made, or is threatened to be made, a party to any Proceeding (including a Proceeding by or in the right of the Company to procure a judgment in its favor) against all Losses and Expenses actually and reasonably incurred by Indemnitee in connection with the Proceeding. No indemnification shall be made under this Section 7(a) on account of Indemnitees conduct which constitutes a breach of Indemnitees duty of loyalty to the Company or its investors or is an act or omission not in good faith or which involves intentional misconduct or a knowing violation of the law.
(b) For purposes of Sections 7(a), the meaning of the phrase to the fullest extent permitted by law shall include, but not be limited to:
i. to the fullest extent authorized or permitted by the then-applicable provisions of the DGCL or other applicable statutory provision, that authorize or contemplate indemnification by agreement, or the corresponding provision of any amendment to or replacement of the DGCL or other applicable statutory provision, and
ii. to the fullest extent authorized or permitted by any amendments to or replacements of the DGCL or other applicable statutory provision, adopted after the date of this Agreement that increase the extent to which a corporation limited liability company or partnership, as applicable may indemnify its officers, directors or persons holding similar fiduciary responsibilities.
(c) Indemnitee shall be entitled to the prompt payment of all Expenses reasonably incurred in enforcing successfully (fully or partially) this Agreement.
8. Exclusions. Notwithstanding any provision in this Agreement, the Company shall not be obligated under this Agreement to make any indemnity in connection with any claim made against Indemnitee:
(a) for which payment actually has been received by or on behalf of Indemnitee under any insurance policy or other indemnity provision, except with respect to any excess beyond the amount actually received under such insurance policy or other indemnity provision; or
(b) for an accounting of profits made from the purchase and sale (or sale and purchase) by Indemnitee of securities of the Company or any subsidiary of the Company within the meaning of Section 16(b) of the Exchange Act, as amended, or similar provisions of state blue sky law, state statutory law or common law; or
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(c) prior to a Change in Control, in connection with any Proceeding (or any part of any Proceeding) initiated by Indemnitee, including any Proceeding (or any part of any Proceeding) initiated by Indemnitee against the Company (other than any Proceeding referred to in Sections 13(d) or (e) below or any other Proceeding commenced to recover any Expenses referred to in Section 7(c) above) or its directors, officers, employees or other indemnitees, unless (i) the Board authorized the Proceeding (or any part of any Proceeding) prior to its initiation or (ii) the Company provides the indemnification, in its sole discretion, pursuant to the powers vested in the Company under applicable law; or
(d) if the funds at issue were paid pursuant to a settlement approved by a court and indemnification would be inconsistent with any condition with respect to indemnification expressly imposed by the court in approving the settlement.
9. Advances of Expenses; Defense of Claim.
(a) Notwithstanding any provision of this Agreement to the contrary, the Indemnitee shall be entitled to advances of Expenses incurred by him or her or on his or her behalf in connection with a Proceeding that Indemnitee claims is covered by Sections 3 and 4 hereof, prior to a final determination of eligibility for indemnification and prior to the final disposition of the Proceeding, upon the execution and delivery to the Company of an undertaking by or on behalf of the Indemnitee providing that the Indemnitee will repay such advances to the extent that it ultimately is determined that Indemnitee is not entitled to be indemnified by the Company. This Section 9(a) shall not apply to any claim made by Indennriitee for which indemnity is excluded pursuant to Section 8.
(b) The Company shall advance pursuant to Section 9(a) the Expenses incurred by Indemnitee in connection with any Proceeding within thirty (30) days after the receipt by the Company of a written statement or statements requesting such advances from time to time, whether prior to or after final disposition of any Proceeding. Advances shall be unsecured and interest free. Advances shall be made without regard to Indemnitees ability to repay such advances. Advances shall include any and all reasonable Expenses incurred pursuing an action to enforce such right to receive advances.
(c) The Company will be entitled to participate in the Proceeding at its own expense.
(d) - The Company shall not settle any action, claim or Proceeding (in whole or in part) which would impose any Expense, judgment, fine, penalty or limitation on the Indemnitee without the Indemnitees prior written consent, which consent shall not be unreasonably withheld.
10. Procedure for Notification and Application for Indemnification.
(a) Within sixty (60) days after the actual receipt by Indemnitee of notice that he or she is a party to or is requested to be a participant in (as a witness or otherwise) any Proceeding, Indemnitee shall submit to the Company a written notice identifying the
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Proceeding. The failure by the Indemnitee to notify the Company within such 60-day period will not relieve the Company from any liability which it may have to Indemnitee (i) otherwise than under this Agreement, and (ii) under this Agreement, provided that if the Company can establish that such failure to notify the Company in a timely manner resulted in actual prejudice to the Company, then the Company will be relieved from liability under this Agreement only to the extent of such actual prejudice.
(b) Indemnitee shall at the time of giving such notice pursuant to Section 10(a) or thereafter deliver to the Company a written application for indemnification. Such application may be delivered at such time as Indemnitee deems appropriate in his or her sole discretion. Following delivery of such a written application for indemnification by Indemnitee, the Indernnitees entitlement to indemnification shall be determined promptly according to Section 11(a) of this Agreement and the outcome of such determination shall be reported to Indemnitee in writing within forty-five (45) days of the submission of such application.
11. Procedure Upon Application for Indemnification.
(a) Upon written application by Indemnitee for indemnification pursuant to Section 10(b) or written statement by Indemnitee for advances of Expenses pursuant to Section 9(b), a determination with respect to Indemnitees entitlement thereto pursuant to the mandatory terms of this Agreement, pursuant to statute, or pursuant to other sources of right to indemnity, and pursuant to Section 12 of this Agreement shall be made in the specific case: (i) by a majority vote of the Disinterested Directors, whether or not such directors otherwise would constitute a quorum of the Board; (ii) by a committee of Disinterested Directors designated by a majority vote of such directors, whether or not such directors would otherwise constitute a quorum of the Board, (iii) if there are no Disinterested Directors or if so requested by (x) the Indemnitee in his or her sole discretion or (y) the Disinterested Directors, by Independent Counsel in a written opinion to the Board, a copy of which shall be delivered to Indemnitee or (iv) by the stockholders of the Company. Indemnitee shall reasonably cooperate with the person, persons or entity making the determination with respect to Indemnitees entitlement to indemnification, including providing to such person, persons or entity upon reasonable advance request any documentation or information which is not privileged or otherwise protected from disclosure and which is reasonably available to Indemnitee and reasonably necessary to such determination. Any costs or expenses (including attorneys fees and disbursements) incurred by Indemnitee in so cooperating with the person, persons or entity making such determination shall be borne by the Company (irrespective of the determination as to lndemnitees entitlement to indemnification) and the Company hereby jointly and severally indemnify and agree to hold Indemnitee harmless from any such costs and expenses.
(b) If it is determined that Indemnitee is entitled to indemnification requested by the Indemnitee in a written application submitted to the Company pursuant to Section 10(b), payment to Indemnitee shall be made within ten (10) days after such determination. All advances of Expenses requested in a written statement by Indemnitee pursuant to Section 9(b) prior to a final determination of eligibility for indemnification shall be paid in accordance with Section 9.
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(c) In the event the determination of entitlement to indemnification is to be made by Independent Counsel pursuant to Section 11(a) hereof, the Independent Counsel shall be selected as provided in this Section 11(c). If a Change in Control shall not have occurred, the Independent Counsel shall be selected by the Board, and the Company shall give written notice to Indemnitee advising him or her of the identity of the Independent Counsel so selected. If a Change in Control shall have occurred, the Independent Counsel shall be selected by Indemnitee (unless Indemnitee shall request that such selection be made by the Board, in which event the preceding sentence shall apply), and Indemnitee shall give written notice to the Company advising it of the identity of the Independent Counsel so selected. In either event, Indemnitee or the Company, as the case may be, may, within ten (10) days after such written notice of selection shall have been received, deliver to the Company or to Indemnitee, as the case may be, a written objection to such selection; provided, however, that such objection may be asserted only on the ground that the Independent Counsel so selected does not meet the requirements of Independent Counsel as defined in Section 2 of this Agreement, and the objection shall set forth with particularity the factual basis of such assertion. Absent a proper and timely objection, the person so selected shall act as Independent Counsel. If a written objection is made and substantiated, the Independent Counsel so selected may not serve as Independent Counsel unless and until such objection is withdrawn or a court of competent jurisdiction has determined that such objection is without merit.
(d) If, within twenty (20) days after submission by Indemnitee of a written request for indemnification pursuant to Section 9(b) or 10(b) hereof, no Independent Counsel shall have been selected and not objected to, either the Company or Indemnitee may petition a court of competent jurisdiction for resolution of any objection which shall have been made by the Company or Indemnitee to the others selection of Independent Counsel and/or for the appointment as Independent Counsel of a person selected by the Court or by such other person as the Court shall designate, and the person with respect to whom all objections are so resolved or the person so appointed shall act as Independent Counsel under Section 11(a) hereof.
(e) The Company shall pay the reasonable fees and expenses of the Independent Counsel and to fully indemnify such Independent Counsel against any and all Expenses, claims, liabilities and damages arising out of or relating to this Agreement or its engagement pursuant hereto.
(I) Upon the due commencement of any judicial proceeding or arbitration pursuant to Section 13 (a) of this Agreement, any Independent Counsel shall be discharged and relieved of any further responsibility in such capacity (subject to the applicable standards of professional conduct then prevailing).
12. Presumptions and Effect of Certain Proceedings.
(a) Presumption in Favor or Indemnitee. In making a determination with respect to entitlement to indemnification hereunder, the person or persons or entity making such determination shall presume that Indenumitee is entitled to indemnification under this Agreement if Indemnitee has submitted an application for indemnification in accordance with Section 10(a) of this Agreement, and the Company shall have the burden of proof to overcome that presumption.
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(b) No Presumption Against Indemnitee. Neither the failure of the Company (including by its Directors or Independent Counsel) to have made a determination prior to the commencement of any action pursuant to this Agreement nor an actual determination by the Company (including by its Directors or Independent Counsel) that Indemnitee has not met the applicable standard of conduct for indemnification shall be a defense to the action or create a presumption that Indemnitee has not met the applicable standard of conduct.
(c) Sixty Day Period for Determination. If the person, persons or entity empowered or selected under Section II of this Agreement to determine whether Indemnitee is entitled to indemnification shall not have made a determination within sixty (60) days after receipt by the Company of an application therefor, a determination of entitlement to indemnification shall be deemed to have been made and Indemnitee shall be entitled to such indemnification, absent (i) a misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make lndemnitees statement not materially misleading, in connection with the application for indemnification, or (ii) a prohibition of such indemnification under applicable law; provided, however, that such 60-day period may be extended for a reasonable time, not to exceed an additional thirty (30) days, if the person, persons or entity making the determination with respect to entitlement to indemnification in good faith requires such additional time for the obtaining or evaluating of documentation and/or infonnation relating thereto.
(d) No Presumption from Termination of a Proceeding. The termination of any Proceeding or of any claim, issue or matter therein, by judgment, order, settlement or conviction, or upon a plea of nolo contendere, or its equivalent, shall not of itself adversely affect the right of Indemnitee to indemnification or create a presumption that Indemnitee did not act in good faith and for a purpose which he or she reasonably believed to be in or not opposed to the best interests of the Company or, with respect to any criminal Proceeding, that Indemnitee had reasonable cause to believe that his or her conduct was unlawful.
(e) Reliance as Safe Harbor. For purposes of any determination of good faith, Indemnitee shall be deemed to have acted in good faith if Indemnitees action or failure to act is based on the records or books of account of the Company or any Enterprise other than the Company, including financial statements, or on information supplied to Indemnitee by the officers of the Company or any Enterprise other than the Company in the course of their duties, or on the advice of legal counsel for the Company or any Enterprise other than the Company or on information or records given or reports made to the Company or any Enterprise other than the Company by an independent certified public accountant or by an appraiser or other expert selected by the Company or any Enterprise other than the Company, except if the Indemnitee knew or had reason to know that such records or books of account of the Company, information supplied by the officers of the Company, advice of legal counsel or information or records given or reports made by an independent certified public accountant or by an appraiser or other expert were materially false or materially inaccurate. The provisions of this Section 12(e) shall not be deemed to be exclusive or to limit in any way the other circumstances in which the Indeinnitee may be deemed or found to have met any applicable standard of conduct.
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(f) Actions of Others. The knowledge and/or actions, or failure to act, of any other director, officer, trustee, administrator, partner, member, fiduciary, employee or agent of the Company or any Enterprise other than the Company shall not be imputed to Indemnitee for purposes of determining the right to indenmification under this Agreement.
13. Remedies of Indemnitee.
(a) AdjudicationlArbitration. In the event that (i) a determination is made pursuant to Section 11 of this Agreement that Indemnitee is not entitled to indemnification under this Agreement, (ii) advancement of Expenses is not timely made pursuant to Section 9 of this Agreement, (iii) subject to Section 12(c), no determination of entitlement to indemnification shall have been made pursuant to Section 11(a) of this Agreement within 60 days after receipt by the Company of the application for indemnification, or (iv) payment of indemnification is not made pursuant to Sections 3, 4, S, 6, 7 and 11(b) of this Agreement within ten (10) days after a determination has been made that Indemnitee is entitled to indemnification, or after receipt by the Company of a written request for any additional monies owed with respect to a Proceeding as to which it already has been determined that Indemnitee is entitled to indemnification, Indemnitee shall be entitled to an adjudication by a court of his or her entitlement to such indemnification or advancement of Expenses. Alternatively, Indemnitee, at his or her option, may seek an award in arbitration to be conducted by a single arbitrator pursuant to the Commercial Arbitration Rules of the American Arbitration Association. The Company shall not oppose Indemnitees right to seek any such adjudication or award in arbitration.
(b) Indemnitee Not Prejudiced by Prior Adverse Determination. In the event that a determination shall have been made pursuant to Section 11(a) of this Agreement that Indemnitee is not entitled to indemnification, any judicial proceeding or arbitration commenced pursuant to this Section 13 shall be conducted in all respects as a de novo trial, or arbitration, on the merits, and Indemnitee shall not be prejudiced by reason of the prior adverse determination. In any judicial proceeding or arbitration commenced pursuant to this Section 13, the Company shall have the burden of proving Indemnitee is not entitled to indemnification or advancement of Expenses, as the case may be.
(c) Company Bound by Prior Determination. If a determination shall have been made pursuant to Section 11(a) of this Agreement that Indemnitee is entitled to indemnification, the Company shall be bound by such determination in any judicial proceeding or arbitration commenced pursuant to this Section 13, absent (i) a misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make Indemnitees statement not materially misleading, in connection with the application for indemnification, or (ii) a prohibition of such indemnification under applicable law.
(d) Expenses. In the event that Indelnnitee, pursuant to this Section 13, seeks a judicial adjudication of or an award in arbitration to enforce his or her rights under, or to recover damages for breach of, this Agreement, Indemnitee shall be entitled to recover from the Company, and shall be jointly and severally indemnified by the Company against, any and all Expenses actually and reasonably incurred by him or her in such judicial adjudication or arbitration if it shall be determined in such judicial adjudication or arbitration that Indemnitee is entitled to receive all or part of the indemnification or advancement of Expenses sought which the Company had disputed prior to the commencement of the judicial proceeding or arbitration.
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(e) Advances of Expenses. If requested by Indemnitee, the Company shall (within ten (10) days after receipt by the Company of a written request therefore) advance to Indemnitee the Expenses which are incurred by Indemnitee in connection with any judicial proceeding or arbitration brought by Indemnitee for indemnification or advance of Expenses from the Company under this Agreement or under any directors and officers liability insurance policies maintained by the Company, if the Indemnitee has submitted an undertaking to repay such Expenses if Indemnitee ultimately is determined to not be entitled to such indemnification, advancement of Expenses or insurance recovery, as the case may be. The Indemnitees financial ability to repay any such advances shall not be a basis for the Company to decline to make such advances.
(f) Precluded Assertions by the Comp . The Company shall be precluded from asserting in any judicial proceeding or arbitration commenced pursuant to this Section 13 that the procedures and presumptions of this Agreement are not valid, binding and enforceable and shall stipulate in any such court or before any such arbitrator that the Company is bound by all the provisions of this Agreement.
14. Non-exclusivity; Survival of Rights; Insurance; Subrogation.
(a) Rights of Indenmitee Not Exclusive. The rights of indemnification and to receive advancement of Expenses as provided by this Agreement shall not be deemed exclusive of any other rights to which Indemnitee may at any time be entitled under applicable law, the Certificate of Incorporation, or the By-Laws, any agreement, vote of investors or a resolution of directors, members, partners, or otherwise. No right or remedy herein conferred by this Agreement is intended to be exclusive of any other right or remedy, and every other right and remedy shall be cumulative and in addition to every other right and remedy given hereunder or now or hereafter existing at law or in equity or otherwise. The assertion or employment of any right or remedy hereunder, or otherwise, shall not prevent the concurrent or subsequent assertion or employment of any other right or remedy.
(b) Survival of Rigs. No amendment, alteration or repeal of this Agreement or of any provision hereof shall limit or restrict any right of Indemnitee under this Agreement in respect of any action taken or omitted by such Indenuutee in his or her Corporate Status prior to such amendment, alteration or repeal.
(c) Change of Law. To the extent that a change in Delaware law, or where applicable California law, whether by statute or judicial decision, permits greater indemnification or advancement of Expenses than would be afforded currently under the Certificate of Incorporation or the By-Laws, or this Agreement, it is the intent of the parties hereto that Indernnitee shall enjoy and be conferred by this Agreement the greater benefits so afforded by such change.
(d) Insurance. To the extent that the Company maintains an insurance policy or policies providing liability insurance for directors, officers, trustees, administrators partners, members, fiduciaries, employees, or agents of the Company or of any other
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Enterprise which such person serves at the request of the Company, Indemnitee shall be covered by such policy or policies in accordance with its or their terms to the maximum extent of the coverage available for any such director, trustee, partner, member, fiduciary, officer, employee or agent under such policy or policies. If, at the time the Company receives notice from any source of a Proceeding as to which Indemnitee is a party or a participant (as a witness or othenvise) the Company has director and officer liability insurance in effect that covers Indernnitee, the Company shall give prompt notice of such Proceeding to the insurers in accordance with the procedures set forth in the respective policies. The Company shall thereafter take all necessary or desirable action to cause such insurers to pay, on behalf of the Indemnitee, all amounts payable as a result of such Proceeding in accordance with the terms of such policies.
(e) Subrogation. In the event of any payment under this Agreement, the Company, shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee, who shall execute all papers required and take all action necessary to secure such rights, including execution of such documents as are necessary to enable the Company to bring suit to enforce such rights.
(f) Other Payments. The Company shall not be liable under this Agreement to make any payment of amounts otherwise indemnif able (or for which advancement is provided hereunder) if and to the extent that Indemnitee has otherwise actually received such payment under any insurance policy, contract, agreement or otherwise.
(g) Other Indemnification, The Companys obligation to indemnify or advance Expenses hereunder to Indemnitee who is or was serving at the request of the Company as a director, officer, trustee, administrator partner, member, fiduciary, employee or agent of any other Enterprise shall be reduced by any amount Indemnitee has actually received as indemnification or advancement of expenses from such Enterprise.
15. Duration of Agreement. This Agreement shall continue until and terminate upon the later of: (a) ten (10) years after the date that Indemnitee shall have ceased to serve as any of the following: a director, officer, agent or employee of the Company or as a director, officer, trustee, administrator partner, member, fiduciary, employee or agent of any other corporation, partnership, joint venture, trust, employee benefit plan or other Enterprise which Indeinnitee served at the request of the Company; or (b) one (1) year after the final termination of any Proceeding (including after the expiration of any rights of appeal) then pending in respect of which Indemnitee is granted rights of indemnification or advancement of Expenses hereunder and of any proceeding commenced by Indemnitee pursuant to Section 13 of this Agreement (including any rights of appeal of any Proceeding commenced pursuant to Section 13). This Agreement shall be binding upon the Company and its respective successors and assigns and shall inure to the benefit of Indemnitee and his or her heirs, executors and administrators,
16. Severability. If any provision or provisions of this Agreement shall be held to be invalid, illegal or unenforceable for any reason whatsoever: (a) the validity, legality and enforceability of the remaining provisions of this Agreement (including, without limitation, each portion of any Section of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable) shall not in
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any way be affected or impaired thereby and shall remain enforceable to the fullest extent permitted by law; (b) such provision or provisions shall be deemed reformed to the extent necessary to conform to applicable law and to give the maximum effect to the intent of the parties hereto; and (c) to the fullest extent possible, the provisions of this Agreement (including, without limitation, each portion of any Section of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable) shall be construed so as to give effect to the intent manifested thereby.
17. Enforcement.
(a) The Company expressly confirms and agrees that it has entered into this Agreement and assumed the obligations imposed on it hereby in order to induce Indemnitee to serve, or to continue to serve, as a director or officer, of the Company, and the Company acknowledges that Indemnitee is relying upon this Agreement in serving or continuing to serve as a director or officer of the Company.
(b) This Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements and understandings, oral, written and implied, between the parties hereto with respect to the subject matter hereof.
18. Modification and Waiver. No supplement, modification or amendment of this Agreement shall be binding unless executed in writing by each of the parties hereto. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions of this Agreement nor shall any waiver constitute a continuing waiver.
19. Successors and Binding Agreement.
(a) The Company will require any successor (whether direct or indirect, by purchase, merger, consolidation, reorganization or otherwise) and any acquiror of all or substantially all of the business or assets of the Company by agreement in form and substance reasonably satisfactory to Indemnitee and/or his or her counsel, expressly to assume and agree to perform this Agreement in the same manner and to the same extent the Company would be required to perform it if no such succession had taken place.
(b) This Agreement will be binding upon and inure to the benefit of the Company and any successor to the Company, including, without limitation, any person acquiring directly or indirectly all or substantially all of the business or assets of the Company whether by purchase, merger, consolidation, reorganization or otherwise (and such successor will thereafter be deemed the Company for purposes of this Agreement), but will not otherwise be assignable or delegatable by the Company.
(c) This Agreement will inure to the benefit of and be enforceable by the Indemnitees personal or legal representatives, executors, administrators, successors, heirs, distributees, legatees and other successors.
(d) This Agreement is personal in nature and neither of the parties hereto
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will, without the consent of the other, assign or delegate this Agreement or any rights or obligations hereunder except as expressly provided in Sections 19(a), (b) and (c). Without limiting the generality or effect of the foregoing, Indemnitees right to receive payments hereunder will not be assignable, whether by pledge, creation of a security interest or otherwise, other than by a transfer by the Indemnitees will, devise, a grantors trust instrument under which the Indcmnitee or his estate is the sole beneficiary, or by the laws of descent and distribution, and, in the event of any attempted assignment or transfer contrary to this Section 19(d), the Company will have no liability to pay any amount so attempted to be assigned or transferred.
20. Notices. All notices, requests, demands and other communications under this Agreement shall be in writing and shall be deemed to have been duly given if: (i) delivered by hand and receipted for by the party to whom said notice or other communication shall have been directed, on the date of such receipt, or (ii) mailed by certified or registered mail with postage prepaid, on the third business day after the date on which it is so mailed:
(a) If to Indemnitee, at the address indicated on the signature page of this Agreement, or such other address as Indemnitee subsequently shall provide in writing to the Company.
(b) If to the Company to:
Medivation, Inc.
201 Spear Street, 3 Floor
San Francisco, California 94105
Attention: Chief Executive Officer
or to any other address as may have been furnished to Indemnitee in writing by the Company.
21. Contribution. To the fullest extent permissible under applicable law, if the indemnification provided for in this Agreement is unavailable to Indemnitee for any reason whatsoever, the Company, in lieu of indemnifying Indemnitee, shall contribute to the amount incurred by Indemnitee, whether for judgments, fines, penalties, excise taxes, amounts paid or to be paid in settlement and/or for Expenses, in connection with any claim relating to an indemnifiable event under this Agreement, in such proportion as is deemed fair and reasonable in light of all of the circumstances of such Proceeding in order to reflect (i) the relative benefits received by the Company, on the one hand, and Indemnitee , on the other, as a result of the event(s) and/or transaction(s) giving cause to such Proceeding; and/or (ii) the relative fault of the Company, on the one hand (and its directors, officers, employees and agents) and Indemnitee, on the other, in connection with such event(s) and/or transaction(s).
22. Applicable Law and Consent to Jurisdiction. This Agreement and the Iegal relations among the parties shall be governed by, and construed and enforced in accordance with, the laws of the State of Delaware, without regard to its conflict of laws, principles or rules. Except with respect to any arbitration commenced by Indemnitee pursuant to Section 13 of this Agreement, the Company and Indemnitee hereby irrevocably and unconditionally
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(i) agree that any action or proceeding arising out of or in connection with this Agreement shall be brought only in the Chancery Court of the State of Delaware (the Delaware Court), and not in any other state or federal court in the United States of America or any court in any other country, (ii) consent to submit to the exclusive jurisdiction of the Delaware Court for purposes of any action or proceeding arising out of or in connection with this Agreement, (iii) irrevocably appoint, to the extent such party is not a resident of the State of Delaware, The Prentice-ITall Corporation System, Inc., 32 Lockerman Square, Suite L-100, Dover, County of Kent, Delaware 19901 as its agent in the State of Delaware as such partys agent for acceptance of legal process in connection with any such action or proceeding against such party with the same legal force and validity as if served upon such party personally within the State of Delaware, (iv) waive any objection to the laying of venue of any such action or proceeding in the Delaware Court, and (v) waive, and agree not to plead or to make, any claim that any such action or proceeding brought in the Delaware Court has been brought in an improper or inconvenient forum.
23. Identical Counterparts. This Agreement may be executed in one or more counterparts, each of which shall for all purposes be deemed to be an original but all of which together shall constitute one and the same Agreement. Only one such counterpart signed by the party against whom enforceability is sought needs to be produced to evidence the existence of this Agreement.
24. Miscellaneous. Use of the masculine pronoun shall be deemed to include usage of the feminine pronoun where appropriate. The headings of the paragraphs of this Agreement are inserted for convenience only and shall not be deemed to constitute part of this Agreement or to affect the construction thereof.
[The remainder of this page is intentionally left, blank.]
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IN WITNESS WHEREOF, the parties have caused this Agreement to be signed as of the day and year first above written,
MEDIVATION, INC. | INDEMNITEE | |||||
By: | ||||||
Chief Financial Officer |
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Exhibit 10.26
August 31, 2011
Cheryl L. Cohen
7930 Deerview Court
Burr Ridge, IL 60527
Dear Cheryl,
It is my great pleasure to offer you the position of Chief Commercial Officer, reporting to me. We are very excited about the possibility of you joining our team, and we look forward to the prospect of working with you again as we gear up to launch MDV3100!
As we discussed, the Chief Commercial Officer will be responsible for the sales and marketing functions. The other two functions currently overseen by the Chief Commercial Officer, medical affairs and CMC, will be transferred to Lynn and Pat, respectively.
Your position will be based in the Chicago area. Following a positive AFFIRM readout, Medivation will open an office in the Chicago area, which will serve as our commercial headquarters.
The following outlines the financial and other terms of our offer:
Your base salary on an annualized basis will be $425,000 payable on the 15th and last day of each month.
Subject to timely completion of your job responsibilities, paid time off (PTO) is at your discretion.
You will also be eligible to participate in Medivations annual employee bonus program. Bonuses are generally paid in the last quarter of each year. Employees who join the company between January 1 and September 30th will be eligible for a prorated bonus in their first year of employment. Employees hired after September 30th will be eligible for a positively prorated bonus payment for the following year.
The target bonus opportunity for your position is 50% of base salary. The actual payout can range from 0% to 150% of this target, based on individual and company performance. The Board of Directors makes an assessment of company achievement against goals for purposes of annual bonus payouts annually, generally in October of each year.
We will recommend to Medivations Board of Directors that you be granted an option to purchase 200,000 shares of stock in the Company at an exercise price equal to the fair market value of the shares on the date the option is granted (as determined in accordance with Medivations Stock Option Grant Date Policy). The Board of Directors generally
201 Spear Street, 3rd Floor San Francisco, CA 94105 (415) 543-3470 Fax (415) 543-3411 www.medivation.com
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approves new hire grants once per quarter. Your options will be submitted for Board approval following your date of employment. The terms of your options will be governed in all respects by the terms of our 2004 Equity Incentive Award Plan and the stock option agreements. A stock option agreement will be provided to you after the Board of Directors has approved your grant. In addition, you may be eligible for future annual equity grants under the Plan based on the level of your position and your performance. Annual grants are typically made in the fourth quarter of each year. Employees must be on board by September 30th in order to be eligible for a year end grant.
As an employee of the Company you will be eligible to enroll in our comprehensive benefits program that includes (health, dental, vision, basic life and basic personal accident insurance). Details will be provided during the new hire orientation.
In addition, Medivation offers a 401(k) plan with employer match that provides you with the opportunity for pre-tax, long-term savings by deferring from 160% of your annual salary, subject to certain maximums. Medivation will make a safe harbor matching contribution equal to 100% of your salary deferrals that do not exceed 3% of your compensation plus 50% of your salary deferrals between 3% and 5% of your compensation. The maximum company contribution is subject to IRS limits.
More detailed information regarding Medivations benefits will be provided to you upon commencement of your employment. All Medivation benefits are revaluated on an annual basis and are subject to change.
As a result of the 1986 Immigration Reform and Control Act we are required to verify the identity and work authorization of all new employees. You will therefore be required to sign the Employment Eligibility Verification (Form I-9). We will need to examine original documents that satisfy these verification requirements within 72 hours of your start of employment. This offer of employment is contingent upon your providing the necessary documentation within that period.
You will abide by Medivations strict company policy that prohibits any new employee from using or bringing with them from any prior employer any proprietary information, trade secrets, proprietary materials or processes of such former employers. Upon starting employment with Medivation, you will be required to sign Medivation's Employee Confidentiality and Invention Assignment Agreement for Employees indicating, among other things, your agreement with this policy.
Employees are generally asked to devote all professional work time to Medivation. If you would like to request an exception for special circumstances, you will need to obtain written permission from your manager.
By signing below you are indicating your understanding that should you accept a position at Medivation, the employment relationship is based on the mutual consent of the employee and the Company. Accordingly, either you or the Company can terminate the employment relationship at will, at any time, with or without cause or advance notice.
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As you requested, Medivation will agree to provide you with severance payments for up to twelve (12) months, which will be in the form of continued payment of your final base salary on our regular payroll schedule after your employment terminates, in the event that Medivation terminates your employment without Cause upon, or within twelve (12) months following, a negative AFFIRM readout. These severance payments will cut-off earlier than twelve (12) months if you obtain new full-time employment after your Medivation employment ends. In addition, as a condition of your receipt of these severance payments, you will be required to provide Medivation with a signed and effective general release of all known and unknown claims in the form provided to you by the Company. The complete terms and conditions of this severance arrangement will be set forth in a separate Severance Benefits Agreement to be signed by you and Medivation, which we will provide to you for your signature by early next week.
This offer of employment is effective for 10 business days from the date of this letter. There are two originals of this letter enclosed. If all of the foregoing is satisfactory, please sign and date each original and return one to me within 10 business days in the enclosed envelope, saving the other original for your files.
Cheryl, on behalf of myself, Pat, Lynn and the entire board, we would be honored to have you join us as a member of our executive leadership team. This is an extremely exciting time to be joining our company, and I am confident that we would enjoy great success working together, and have a great time doing so!
I sincerely hope that you will choose to accept our offer.
With best regards,
David T. Hung, MD
President and CEO
I accept employment with the Company on the foregoing terms.
|
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Name | ||||||||||||
8/31/11 | 9/6/11 | |||||||||||
Date Signed | Anticipated Start Date |
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Exhibit 10.27
OFFICE LEASE
525 Market Street
San Francisco, California
KNICKERBOCKER PROPERTIES, INC. XXXIII,
Landlord
and
MEDIVATION, INC.,
Tenant
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ARTICLE 35 - TERMINATION OF MASTER LEASE AND MASTER SUBLEASE |
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TABLE OF CONTENTS
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LIST OF EXHIBITS |
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EXHIBIT A |
FLOOR PLAN | 35 | ||||
EXHIBIT B |
RULES AND REGULATIONS | 38 | ||||
EXHIBIT C |
WORKLETTER AGREEMENT | 43 | ||||
EXHIBIT D |
DESIGN STANDARDS | 52 | ||||
EXHIBIT E |
ESTOPPEL CERTIFICATE | 53 | ||||
EXHIBIT F |
CALIFORNIA ASBESTOS NOTIFICATION | 55 | ||||
EXHIBIT G |
TERMS OF RIGHT OF FIRST OFFER | 60 | ||||
EXHIBIT H |
TERMS OF EXTENSION OPTION | 63 | ||||
EXHIBIT I |
FORM OF LETTER OF CREDIT | 65 |
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OFFICE LEASE
THIS OFFICE LEASE (the Lease) is made and entered into as of December 28, 2011 (the Effective Date) by and between KNICKERBOCKER PROPERTIES, INC. XXXIII, a Delaware corporation (Landlord), and MEDIVATION, INC., a Delaware corporation (Tenant).
Landlord and Tenant specifically agree as follows:
ARTICLE 1DEFINED TERMS AND BASIC TERMS
The terms listed below shall have the following meanings throughout this Lease:
(a) | Landlord: Knickerbocker Properties, Inc. XXXIII, a Delaware corporation |
(b) | Landlords Agent: Cushman & Wakefield of California, Inc., a California corporation |
(c) | Tenant: Medivation, Inc., a Delaware corporation |
(d) | Building: 525 Market Street, San Francisco, California |
(e) | Premises: The entire rentable area of the thirty-fifth (35th) and thirty-six (36th) floors of the Building as shown on Exhibit A attached hereto |
(f) | Rentable Office Area of Building: (1) 1,016,925 rentable square feet for purposes of determining Tenants Percentage Share (Direct Expenses) and (2) 1,031,952 rentable square feet for purposes of determining Tenants Percentage Share (Taxes) |
(g) | Rentable Area of the Premises: stipulated to be 57,172 rentable square feet |
(h) | Term: Eighty-four (84) months, commencing on the Commencement Date |
(i) | Commencement Date: The earlier to occur of (i) one hundred eighty days (180) days after the delivery of the Premises to Tenant which date shall be extended on a day-for-day basis for Landlord Delays (as defined in Exhibit C attached hereto) and (ii) the date Tenant commences its business operations from the Premises. The scheduled commencement date is estimated to be June 1, 2012. |
(j) | Expiration Date: The last day of the eighty-fourth (84th) full calendar month following the Commencement Date |
(k) | Base Rent: The Annual Base Rent and Monthly Base Rent payable by Tenant for the Premises during the initial Term shall be as set forth in the following schedule: |
Months of Lease Term |
Annual Base Rent | Monthly Base Rent | Annual Base Rent Rate Per Rentable Square Foot of the Premises |
|||||||||
1-12 |
$ | 3,087,288.00 | $ | 257,274.00 | $ | 54.00 | * | |||||
13-24 |
$ | 3,144,460.00 | $ | 262,038.33 | $ | 55.00 | ||||||
25-36 |
$ | 3,201,632.00 | $ | 266,802.67 | $ | 56.00 | ||||||
37-48 |
$ | 3,258,804.00 | $ | 271,567.00 | $ | 57.00 | ||||||
49-60 |
$ | 3,315,976.00 | $ | 276,331.33 | $ | 58.00 | ||||||
61-72 |
$ | 3,373,148.00 | $ | 281,095.67 | $ | 59.00 | ||||||
73-84 |
$ | 3,430,320.00 | $ | 285,860.00 | $ | 60.00 |
* | Subject to Section 4.0l(b). |
(1) | Base Year: 2012 |
(m) | Tenants Percentage Share (Direct Expenses): 5.6220% |
(n) | Tenants Percentage Share (Taxes): 5.5402% |
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(o) | Security Deposit: Letter of Credit in the initial stated amount of Five Million One Hundred Forty-Five Thousand Four Hundred Eighty Dollars ($5,145,480.00) (see Article 7) |
(p) | Use: General office use consistent with the character of the Building as a first-class office building |
(q) | Tenants Address for Notices: Until Tenant commences business operations from the Premises: |
Medivation, Inc.
201 Spear Street, 3rd Floor
San Francisco, CA 94105
Attention: Patrick Machado
Thereafter:
Medivation, Inc.
525 Market Street, Suite 3600
San Francisco, California 94105
Attention: Patrick Machado
(r) | Landlords Address for Notices: |
Knickerbocker Properties, Inc. XXXIII
c/o Cushman & Wakefield of California, Inc.
525 Market Street, Suite 1870
San Francisco, California 94105
Attn: Property Manager
With a simultaneous copy to:
Knickerbocker Properties, Inc. XXXIII
c/o J.P. Morgan Asset Management
Global Real Assets-Real Estate Americas
2029 Century Park East, Suite 4150
Los Angeles, California 90067
Attn: Asset Manager for 525 Market Street
(s) | Brokers: Cushman & Wakefield of California, Inc. for Landlord and Jones Lang LaSalle for Tenant |
(t) | Other Defined Terms: Certain other defined terms are defined when they first appear within the body of this Lease |
2.01 Premises. Landlord hereby leases to Tenant, and Tenant hereby leases from Landlord, the Premises, for the Term and subject to the agreements, conditions and provisions contained in this Lease to each and all of which Landlord and Tenant hereby mutually agree. Landlord shall deliver the Premises to Tenant within ten (10) days following the mutual execution and delivery of this Lease and the failure to do so shall constitute a Landlord Delay.
2.02 Rentable Area. The Rentable Area of the Premises and the Rentable Office Area of the Building shall mean the amounts as set forth and stipulated in Article l(f) and (g), respectively. The Rentable Area of the Premises and Tenants Percentage Share (Direct Expenses) and Tenants Percentage Share (Taxes) shall not be changed during the Term except in connection with a change in the physical size of the Premises and/or Building.
2.03 Common Areas. Common Areas shall mean the lobby, plaza and sidewalk areas, subterranean garage and other similar areas of general access and the areas on individual floors in the Building devoted to corridors, fire vestibules, elevators, foyers, lobbies, electric and telephone closets, stairways, restrooms,
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mechanical rooms, janitors closets, and other similar facilities and shall also mean those areas of the Building devoted to mechanical and service rooms and levels servicing the Building and basement, mezzanine and penthouse service facilities.
2.04 Condition of the Premises. Except as specifically set forth in this Lease and in the Workletter Agreement attached hereto as Exhibit C (the Workletter), Landlord shall not be obligated to provide or pay for any improvement work or services related to the improvement of the Premises. Tenant also acknowledges that Landlord has made no representation or warranty regarding the condition of the Premises or the Building except as specifically set forth in this Lease and the Workletter. Except for the work to be performed by Landlord as described in the Workletter, if any, Tenant accepts the Premises in an as is condition.
2.05 Right of First Offer. Tenant shall have a right of first offer for certain space on the 37th floor of the Building in accordance with the terms set forth on Exhibit G attached hereto.
2.06 Generator. In the event Tenant desires to install a back-up generator, Landlord agrees to consider any such request in good faith, but approval thereof shall require Landlords consent, which consent may be conditioned or withheld in Landlords sole and absolute discretion.
3.01 Term. Upon the execution of this Lease by both parties, the terms and provisions hereof shall be fully binding upon Landlord and Tenant prior to the occurrence of the Commencement Date (as hereinafter defined). The term of this Lease (the Term) shall commence on the Commencement Date as specified in Article l(i). Unless sooner terminated as hereinafter provided, the Term shall end on the Expiration Date specified in Article l(j). If Landlord does not tender possession of the Premises to Tenant on or before June 1, 2012, for any reason whatsoever, Landlord shall not be liable for any damage thereby, this Lease shall not be void or voidable thereby, and, except as otherwise provided in the Workletter, if any, Tenant shall not be liable for any rent until Landlord tenders possession of the Premises to Tenant. No failure to tender possession of the Premises to Tenant on or before the scheduled commencement date shall: (i) in any way affect any other obligations of Tenant hereunder, or (ii) extend the Expiration Date; provided, however, that in the event Landlord has not delivered possession of the Premises by April 2, 2012, for any reason whatsoever, Tenant may on or before April 5, 2012 deliver thirty (30) days written notice to Landlord of its election to terminate this Lease, and if Landlord does not deliver the Premises to Tenant within such thirty (30) day period, Tenant may terminate this Lease by a subsequent five (5) days written notice to Landlord. In the event of such termination under this Section 3.01, Landlord shall return all funds deposited by Tenant, the Lease shall terminate as of the date set forth in Tenants notice, and neither party shall have further liability under this Lease. Time is of the essence in this Article 3, and all notices shall be delivered strictly in accordance with Article 30 and Article l(r).
3.02 Extension Option. Notwithstanding the foregoing, Tenant shall have the one-time option to extend the Term pursuant to the terms of Exhibit H attached hereto.
3.03 Acceptance of Possession. Once the Commencement Date has been determined, Landlord and Tenant shall execute an amendment to this Lease stating the Commencement Date, but failure of the parties to execute such an amendment shall have no impact on the Commencement Date. Tenants acceptance of possession of the Premises (whether before or after the Commencement Date) shall constitute Tenants acknowledgment that the Premises are in good order and satisfactory condition. For purposes of determining whether Tenant has accepted possession of the Premises, Tenant shall be deemed to have done so when Tenant first moves any of its personnel and/or furnishings and/or equipment into the Premises, except to the extent that Tenant is explicitly authorized in this Lease or by Landlords agreement in writing to do any of the foregoing without being deemed to have accepted possession of the Premises.
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(a) Tenant shall pay to Landlord for the use of the Premises an Annual Base Rent in the amount specified in Article l(k) (subject to adjustment as provided in Articles 5 and 6), payable without notice or demand in equal monthly installments in advance, beginning on the Commencement Date as set forth in Article 1(j) and on the first day of each calendar month thereafter during the Term (subject to abatement as set forth in Section 4.01(b), below) in the sum specified in Article l(k) (the Monthly Base Rent).
(b) Provided that there is not a continuing Event of Default beyond any applicable notice and cure periods hereunder, Landlord hereby agrees to conditionally abate Tenants obligation to pay Monthly Base Rent for the entire Premises for the first three (3) full calendar months of the Term (Abated Rent). During such abatement period, Tenant shall remain responsible for the payment of all of its other monetary obligations under this Lease. In the event an Event of Default shall occur beyond any applicable notice and cure periods hereunder, the Abated Rent shall be immediately due and payable by Tenant and shall constitute rent payable hereunder.
4.02 Payment. All payments required to be made by Tenant under this Lease shall be in lawful money of the United States of America and shall be made without any setoff, deduction or counterclaim whatsoever and shall be made payable to and delivered to Landlord at the office of Landlord in the Building or such other place as Landlord may designate. Landlord shall have the right to require payments to be made in current funds transmitted by wire transfer to Landlord to a bank designated by Landlord. Concurrently with the execution of this Lease, Tenant shall pay to Landlord the first installment of the Monthly Base Rent due hereunder.
4.03 Partial Months. If the Commencement Date is a day other than the first day of a calendar month or if the Term expires or is terminated on a day other than the last day of a calendar month, then the Monthly Base Rent for the first and last fractional months of the Term shall be prorated on the basis of the number of days elapsed of the subject month.
ARTICLE 5DIRECT EXPENSES ADJUSTMENT
5.01 Increased Direct Expenses. The Base Year is that calendar year specified in Article 1(1). The Annual Base Rent payable during each calendar year of the Term subsequent to the Base Year shall be increased by Tenants Percentage Share (Direct Expenses) as specified in Article l(m) of any increase in Direct Expenses, as defined in Section 5.02, paid or incurred by Landlord during such calendar year in excess of the Direct Expenses paid or incurred by Landlord during the Base Year (which increase is hereinafter referred to as the Increased Direct Expenses). Landlord will endeavor to use commercially reasonable efforts to, at or after the Commencement Date and the start of any calendar year subsequent to the Base Year, notify Tenant by April 1 of the amount which Landlord estimates will be Tenants monthly share of Increased Direct Expenses for such calendar year, and the amount of such estimated Increased Direct Expenses shall be added to the Monthly Base Rent payments required to be made by Tenant in such year. A Statement (the Statement) of the Increased Direct Expenses payable by Tenant for each year subsequent to the Base Year shall be given to Tenant within a reasonable period of time after the end of each calendar year. If Tenants Percentage Share of any Increased Direct Expenses as shown on such Statement is greater or less than the total estimated amounts actually paid by Tenant during the year covered by such Statement, then within fifteen (15) days thereafter, Tenant shall pay in cash any sums owed Landlord or, if applicable, Tenant shall receive a credit against any rent next accruing for any sum owed Tenant. If this Lease expires or is terminated on a day other than the last day of a calendar year, the amount of Increased Direct Expenses payable by Tenant during the year in which the Lease expires or is terminated shall be prorated on the basis which the number of days from the commencement of the calendar year to and including the date on which the Lease expires or is terminated bears to three hundred sixty (360), and shall be due and payable monthly in advance notwithstanding the expiration or earlier termination of the Term. Following expiration of the calendar year in which the Lease expires or is terminated, Landlord shall
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give a final Statement to Tenant for such calendar year. If Tenants share of any Increased Direct Expenses as shown on the final Statement is greater or less than the total amounts of Increased Direct Expenses actually paid by Tenant during the year covered by the final Statement, then within thirty (30) days thereafter the appropriate party shall pay to the other party any sums owed in the manner provided above. If, after Landlord has issued a final Statement for a particular calendar year, subsequent reviews by Landlord of its books and records indicate that Landlord has undercharged Direct Expenses, or if subsequent to a calendar year Landlord determines that charges subsequently received by Landlord were reasonably attributable to such calendar year, Landlord may issue a revised final Statement, and Tenant shall, within fifteen (15) days thereafter, pay to Landlord Tenants Percentage Share (Direct Expenses) of the additional Increased Direct Expenses.
5.02 Direct Expenses. Direct Expenses as used herein shall include, without duplication, all costs, charges and expenses incurred in the course of ownership, management, administration, operation, repair and maintenance of the Building, the Common Areas and the areas adjacent thereto, including, without limitation:
(a) Wages, salaries and other compensation, expenses, benefits, and other sums payable, as well as any adjustment thereto, for employees, independent contractors and agents of Landlord.
(b) Costs and payments of service, maintenance, and inspection for landscaping, janitorial, window cleaning, rubbish removal, exterminating, elevator, escalator, life safety, security, plumbing, telecommunication, electrical and mechanical equipment or installations and the costs of purchasing or renting all such additional mechanical installations and equipment, supplies, tools, materials and uniforms.
(c) Premiums and other charges for insurance, including, without limitation, all risk, earthquake, public liability, property damage and workers compensation insurance, and such other insurance coverage in such amounts as Landlord, in its sole discretion, shall elect to maintain.
(d) Costs of electricity, water, gas, steam, sewer and other utility services as described in Article 9 below.
(e) Sales, use and excise taxes on goods and services purchased or furnished by Landlord.
(f) License, permit, testing and inspection costs and fees.
(g) Reasonable attorneys, accountants and consultants fees.
(h) Fees for local civic organizations and dues for professional and trade associations, including, without limitation, any amount paid to local civic groups for the betterment of the neighborhood in which the Building is located.
(i) Fees for management and accounting services and costs incidental thereto, whether provided by an independent management company, Landlord, or an affiliate of Landlord, not in excess of such fees typically charged by landlords of comparable properties in downtown San Francisco.
(j) The costs of any capital improvements, equipment or devices installed or paid for by Landlord (including the costs of any changes to the Building HVAC system (as defined in Section 9.01 (a)) in order to conform with any change subsequent to the Commencement Date in laws, rules, regulations, enforcement policies or requirements of any governmental or quasi-governmental authority having jurisdiction or of the Board of Fire Underwriters or similar insurance body. The reasonable annual amortization (amortized over the shorter of the useful life of the Building or the useful life of the capital improvement in question), of the cost of such improvements (which direct cost shall include interest at the Prime Rate as defined in Section 5.01 (o) on the date such cost is incurred) shall be deemed Direct Expenses in each year during the term of the amortization period.
(k) The costs of any capital improvements (including capital improvements required by law), equipment or devices installed or paid for by Landlord and reasonably intended to effect a labor saving, energy saving measure or to effect other economies in the operation or maintenance of the Building, as well as interest on the unamortized balance at the Prime Rate on the date the costs are incurred or such higher rate as may have been paid by Landlord on such borrowed funds. Such costs shall be amortized over the
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shorter of the useful life of the improvements, or the period over which the labor or energy saving costs equal the improvement cost.
(1) The costs of minor capital improvements or expenditures where each such improvement or expenditure costs less than Three Thousand Dollars ($3,000).
(m) The costs of (i) exterior window coverings provided by Landlord, (ii) carpeting and wall coverings in the Common Areas, and (iii) other fixtures and furnishings in Common Areas which, as a result of normal use, require periodic replacement, amortized over the useful life of such improvements (as determined by Landlord), as well as interest on the unamortized balance at the Prime Rate on the date the costs are incurred or such higher rate as may have been paid by Landlord on borrowed funds, if more than thirty-five percent (35%) of the window coverings, carpeting or furnishings are replaced during any calendar year. If thirty-five percent (35%) or less of the window coverings, carpeting or furnishings are replaced during any calendar year then the entire cost of replacing such draperies, window coverings, carpeting or furnishings shall be Direct Expenses in the calendar year the cost is incurred.
(n) Depreciation or amortization of the costs of materials, tools, supplies and equipment purchased by Landlord to enable Landlord to supply services which Landlord might otherwise contract for with a third party where such depreciation and amortization would otherwise have been included in the charge for such third partys services.
(o) Prime Rate shall mean the base rate (or its equivalent) of interest announced publicly in New York, New York from time to time by Citibank, N. A. (or if Citibank, N.A. ceases to exist, the largest bank headquartered in the State of New York), but in no event in excess of the maximum rate of interest permitted by law.
(p) In determining the amount of Direct Expenses which vary with the occupancy rate of the Building, if less than one hundred percent (100%) of the Building rentable area shall have been occupied by tenant(s) at any time during any such year, such Direct Expenses shall be determined for such year to be an amount equal to the like expenses which would normally be expected to be incurred had such occupancy been one hundred percent (100%) throughout such year.
(q) Notwithstanding anything contained herein to the contrary, Direct Expenses shall not include: (i) legal fees, brokerage fees, leasing commissions, advertising costs or other related expenses incurred by Landlord in connection with the leasing of tenant space in the Building; (ii) repairs, alterations, additions, improvements or replacements of a capital nature made to rectify or correct any material defect in the original design, materials or workmanship of the Building or Common Areas; (iii) damage and repairs attributable to fire or other casualty to the extent covered by insurance; (iv) salaries of personnel to the extent of time not actually allocated to the management, operation, administration, repair or maintenance of the Building; (v) legal fees, accounting fees and other professional expenses incurred in connection with disputes with tenants or occupants of the Building or associated with the enforcement of the terms of any leases with tenants or the defense of Landlords title to or interest in the Building; (vi) costs (including permits, licensing and inspection fees) incurred in renovating or otherwise improving, decorating, painting or altering space for tenants or licensees (excluding Common Areas) in the Building; (vii) any payments of interest or principal payable by Landlord with respect to any debts secured by a deed of trust or mortgage on the Building or the underlying real property; (viii) depreciation on the Building; (ix) all items and services for which Tenant directly reimburses Landlord or pays third persons or which Landlord provides selectively without direct reimbursement to one or more tenants or occupants of the Building (other than Tenant) which are not customary for normal office or retail use; (x) all costs incurred which are subject to direct reimbursement by other tenants of Building or other parties, including expenses for repair or replacement paid by proceeds of insurance or through condemnation awards; (xi) damage or repair to the Building necessitated by the active negligence or willful misconduct of Landlord or Landlords employees, contractors, or agents; (xii) compensation paid to officers or executives of the entity comprising the Landlord and who are not involved in the management of the Building; (xiii) any fines, interest or penalty assessed against Landlord by a governmental entity; and (xiv) any amounts payable by Landlord under an
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indemnity to a third party; (xv) any costs incurred in the ownership of the Building, as opposed to the operation and maintenance of the Building, including Landlords income taxes, excess profit taxes, franchise taxes or similar taxes on Landlords business, preparation of income tax returns, corporation, partnership or other business form organizational expenses, franchise taxes, filing fees, or other such expenses; (xvi) advertising and promotional expenses, brochures and holiday decorations and holiday events with respect to the Building; (xvii) overhead and profit increment paid to subsidiaries or affiliates of Landlord for services on or to the Property, to the extent that the costs of such services materially exceed market-based costs for such services on an apples-to-apples basis rendered by unaffiliated persons or entities of similar skill, competence and experience; (xviii) penalties, fines, legal expenses, or late payment interest incurred by Landlord due to a willful or negligent violation by Landlord, or Landlords agents, contractors or employees, of either the payment terms and conditions of any lease or service contract covering space in the Building or Landlords obligations as owner of the Building (such as late payment penalties and interest on real estate taxes, late payment of utility bills); (xix) any compensation paid to clerks, attendants or other persons in any commercial concession operated by Landlord in the Building (other than services expressly contemplated by this Lease) from which Landlord receives market compensation therefor, whether or not Landlord actually makes a profit from such concession; (xx) costs incurred in connection with remediating Hazardous Substances contamination in the Building; (xxi) costs of compliance with laws where the violation existed prior to the Commencement Date; and (xxii) political contributions.
5.03 Statement of Increased Direct Expenses. The annual Statement of Increased Direct Expenses shall be made by or verified by an accounting or auditing officer of Landlord or, at Landlords election, by an independent certified public accountant (CPA). Within three (3) months after receipt of the Statement (Audit Period), Tenant (together with its independent certified public accountants, provided that it is a nationally recognized accounting firm which is not compensated on a contingent fee basis) shall be entitled, upon five (5) days prior written notice and during normal business hours at Landlords office or such other place in the San Francisco Bay area as Landlord shall designate, to inspect and examine those books and records of Landlord relating to the determination of Direct Expenses for the calendar year for which the Statement was prepared (such year is referred to as the Audited Year). Tenant recognizes the confidential nature of such books and records and agrees to maintain the information obtained from such examination in strict confidence. If, after inspection and examination of such books and records, which must be commenced within ten (10) days of such books and records being made available to Tenant (Examination Period), and conducted in an expeditious and continual manner and completed as soon as reasonably practicable thereafter, Tenant still disputes the amounts of Direct Expenses charged by Landlord, Tenant shall have thirty (30) days, by written notice to Landlord, to request an independent audit of such books and records (Request Period). The independent audit of the books and records shall be conducted by a CPA acceptable to both Landlord and Tenant. If, within thirty (30) days after Landlords receipt of Tenants notice requesting an audit, Landlord and Tenant are unable to agree on the CPA to conduct such audit, then Landlord shall designate a nationally recognized accounting firm not then employed by Landlord or Tenant to conduct such audit, within thirty (30) days following the expiration of the Request Period. The audit shall be limited to the determination of the amount of Direct Expenses for the Audited Year. If the audit discloses that the amount of Increased Direct Expenses billed to Tenant for the Audited Year was incorrect, the appropriate party shall pay to the other party the deficiency or overpayment, as applicable. All costs and expenses of the audit shall be paid by Tenant unless the audit shows that Landlord overstated Direct Expenses for the Audited Year by more than five percent (5%), in which case Landlord shall pay all costs and expenses of the audit. Tenant shall keep any information gained from such audit confidential and shall not disclose it to any other party unless required to do so by applicable law. The exercise by Tenant of its audit rights hereunder shall not relieve Tenant of its obligation to pay prior to the request for an inspection and examination of Landlords books and records or any audit all sums due hereunder, including, without limitation, the disputed Increased Direct Expenses. If Tenant does not elect to exercise its rights to audit during the Audit Period, and does not elect to examine the books and records during the Examination Period, and does not elect to cause the books and records to be audited during the Request Period, then Landlords annual Statement shall conclusively be deemed to be correct, and Tenant shall be bound by Landlords determination.
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6.01 Increased Taxes. The Annual Base Rent payable during each calendar year of the Term subsequent to the Base Year shall be increased by Tenants Percentage Share (Taxes) (as specified in Article l(n)) of any increase in taxes (Taxes as defined in Section 6.02) paid or incurred by Landlord during such calendar year in excess of the amount of Taxes paid or incurred by Landlord during the Base Year (which increase is hereinafter referred to as the Increased Taxes). Landlord will endeavor to use commercially reasonable efforts to, at or after the Commencement Date or the start of any calendar year subsequent to the Base Year, notify Tenant by April 1 of the amount which Landlord estimates will be Tenants monthly share of Increased Taxes for such calendar year, and the amount thereof shall be added to the Monthly Base Rent payments required to be made by Tenant in such year. Statements of the Increased Taxes payable by Tenant for each year subsequent to the Base Year shall be given to Tenant within a reasonable period of time after the end of each calendar year. If Tenants share of any Increased Taxes as shown on such statement is greater or less than the total amounts actually paid by Tenant during the year covered by such statement, then within fifteen (15) days thereafter, Tenant shall pay in cash any sums owed Landlord or, if applicable, Tenant shall receive a credit against any rent next accruing for any sum owed Tenant. If this Lease expires or is terminated on a day other than the last day of a calendar year, the amount of Increased Taxes payable by Tenant during the year in which the Lease expires or is terminated shall be prorated on the basis which the number of days from the commencement of the calendar year to and including the date on which the Lease expires or is terminated bears to three hundred sixty (360), and shall be due and payable monthly in advance notwithstanding the expiration or earlier termination of the Term. Following expiration of the calendar year in which the Lease expired or was terminated, Landlord shall give a final statement of Increased Taxes for such calendar year. If Tenants share of any Increased Taxes as shown on such final statement is greater or less than the total amounts of Increased Taxes actually paid by Tenant during the year covered by the statement, then within thirty (30) days thereafter the appropriate party shall pay to the other party any sums owed. If the State of California or the City and County of San Francisco changes the real property tax collection procedure from the existing procedure or timing, Landlord shall have the right to require Tenant to pay Tenants pro rata portion of such cost thirty (30) days prior to the due date of such cost.
6.02 Taxes. Taxes as used herein shall include all taxes, assessments and charges (including costs and expenses (including, without limitation, reasonable legal fees and disbursements) of contesting the amount or validity thereof by appropriate administrative or legal proceedings) levied upon or with respect to the Building or any personal property of Landlord, or Landlords interest in the Building or such personal property, including, without limitation, all real property taxes and general and special assessments; charges, fees, levies or assessments for transit, housing, police, fire or other governmental services or purported benefits to the Building; service payments in lieu of taxes; and any tax, fee or excise on the act of entering into this Lease or any other lease of space in the Building, on the use or occupancy of the Building or any part thereof, or on the rent payable under any lease or in connection with the business of renting space in the Building, which may now or hereafter be levied or assessed against Landlord by the United States of America, the State of California, or any political subdivision, public corporation, district or other political or public entity, and any other tax, fee or other excise, however described, that may be levied or assessed as a substitute for, or as an addition to (in whole or in part) any other property taxes, whether or not now customary or in the contemplation of the parties on the date of this Lease. In addition, Taxes shall include the costs (amortized over such period as Landlord shall reasonably determine), of any transit impact development fees, housing and child care contributions or other similar or dissimilar impositions required of Landlord by the City and County of San Francisco or the State of California and interest on the unamortized balance at the Prime Rate prevailing from time to time.
6.03 Additional Taxes. In addition to the Monthly Base Rent and other charges to be paid by Tenant hereunder, Tenant shall reimburse Landlord upon demand for any and all taxes, surcharges, levies, assessments, fees and charges payable by Landlord, whether or not now customary or within the contemplation of the parties hereto: (a) upon, measured by or reasonably attributable to the cost or value of Tenants equipment, furniture, fixtures and other personal property located in the Premises, or the cost or value of any leasehold improvements, regardless of whether title to such improvements shall be in Tenant or Landlord; (b) upon, or measured by, any
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rent or other amounts payable hereunder, including, without limitation, any gross income tax, gross receipts tax or excise tax levied by the City and County of San Francisco, the State of California, the federal government of the United States or any other governmental body with respect to the receipt of such rent or other amounts; (c) upon, or with respect to, the possession, leasing, operation, management, maintenance, alteration, repair, restoration, use or occupancy by Tenant of the Premises or any portion thereof; or (d) upon this transaction or any document to which Tenant is a party creating or transferring an interest or an estate in the Premises.
6.04 Exclusion. Notwithstanding the foregoing, federal, state, and local documentary transfer taxes, gift, franchise, inheritance, gross receipts, transfer, succession and estate taxes, and income taxes shall not be included as Taxes unless any such taxes are paid for the normal use, operation, maintenance or repair of the Building, nor shall the computation of increases in Taxes for which Tenant shall pay Tenants Percentage Share include any amounts paid by Tenant under Section 6.03 or any amounts separately billed to a particular tenant of the Building with respect to similar matters (other than as its percentage share of increases in Taxes).
6.05 Refund. In the event that Landlord receives a cash refund of Taxes due to an overpayment, Tenants pro-rata share of such refund shall be credited against Tenants obligation to pay its pro rata share of subsequent Taxes under this Article.
Concurrently with the execution of this Lease, Tenant shall, as security for the payment and performance of Tenants obligations under the Lease, deliver to Landlord an irrevocable standby letter of credit (the Letter of Credit), the form of which is attached hereto as Exhibit I, issued by Bank of America, N.A. (or such other financial institution acceptable to Landlord) with an initial stated amount of $5,145,480.00 (the Stated Amount). Landlord may, in its sole discretion, require that the Letter of Credit be confirmed by a financial institution satisfactory to Landlord. If, at any time, an Event of Default occurs, Landlord shall have the right to draw down on the Letter of Credit, or so much thereof as necessary, in payment of Rent, in reimbursement of any expense incurred by Landlord in accordance with this Lease, and in payment of any damages incurred by Landlord by reason of such Event of Default for which Tenant is responsible in accordance with the terms of this Lease. In such event, Tenant shall within two (2) business day following written request therefor from Landlord remit to Landlord a sufficient amount in cash to restore the Letter of Credit to the original amount or, at Landlords election, cause the Stated Amount to be fully reinstated to its amount immediately prior to such Event of Default. If the entire Letter of Credit has not been utilized, the remaining amount of the Letter of Credit will be delivered to Tenant or to whoever is then the holder of Tenants interest in this Lease, without interest, within sixty (60) days after full performance of this Lease by Tenant. Tenant shall not be entitled to any interest on the Letter of Credit. Tenant hereby waives the provisions of California Civil Code Section 1950.7, and all other provisions of law, now or hereafter in force, which provide that Landlord may claim from a security deposit only those sums reasonably necessary to remedy any Events of Default with respect to the payment of Rent, to repair damage caused by Tenant or to clean the Premises, it being agreed that Landlord may, in addition, claim those sums reasonably necessary to compensate Landlord for any other loss or damage, foreseeable or unforeseeable, caused by the act or omission of Tenant or any officer, employee, agent or invitee of Tenant which led to the Event of Default. Upon the occurrence of an Event of Default, in addition to Landlords right to draw on the Letter of Credit in whole or in part, Tenant shall, at Landlords option, replace the Letter of Credit with a cash deposit equal to then outstanding Stated Amount (and the Letter of Credit shall be returned to Tenant upon such payment and the expiration of any applicable preference period). Any cash remaining in Landlords possession after a partial or full draw on the Letter of Credit shall be retained as an additional security deposit and the terms of this Article shall apply with respect thereto, mutatis mutandis.
8.01 General. The Premises shall be used only for general office use and for the purposes specified in Article l(p) and for no other use or purpose without Landlords prior written consent, which consent may be withheld in Landlords sole and absolute discretion.
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8.02 No Nuisance or Waste. Tenant shall not do or permit anything to be done in, or about the Premises which will in any way obstruct or interfere with the rights of Landlord and other tenants or occupants or invitees of the Building or injure or annoy them or use or allow the Premises to be used for any improper, immoral or objectionable purpose, nor shall Tenant cause, maintain or permit any nuisance in, on, or about the Building or the Premises. Tenant shall not commit or suffer the commission of any waste in, on, or about the Building or the Premises.
8.03 No Illegal Use. Tenant shall not use the Premises or permit anything to be done in or about the Premises which will in any way conflict with any law, statute, ordinance, or governmental rule, regulations, and/or requirements (collectively, Laws) now in force or which may hereafter be enacted or promulgated or which conflicts with any certificate of occupancy for the Building or is prohibited by the Rules and Regulations attached hereto as Exhibit B. Tenant shall not do or permit anything to be done in or about the Premises or bring or keep anything therein which will in any way increase the rate of applicable insurance upon the Building or any of its contents, and Tenant shall, at its sole cost and expense, promptly comply with all Laws now in force or which may hereafter be in force, and with the requirements of any Insurance Services Office or other similar body now or hereafter constituted relating to or affecting the condition, use, or occupancy of the Premises, excluding structural changes or capital improvements not related to or affected by Tenants alterations or improvements. The judgment of any court of competent jurisdiction or the admission of Tenant in an action against Tenant, whether Landlord be a party thereto or not, that Tenant has so violated any Law shall be conclusive of such violation as between Landlord and Tenant.
8.04 Alterations to Common Areas. If changes or alterations are made by Landlord to any portion of the Building, including, without limitation, the Common Areas, Landlord shall not thereby be subject to any liability nor shall Tenant be entitled to any compensation or any reduction or abatement of rent and such changes or alterations shall not be deemed to be a constructive or actual eviction or a breach of Landlords covenant of quiet enjoyment. Notwithstanding the foregoing, at all times during which Landlord, or Landlords employees or agents are performing such changes or alterations to any portion of the Common Area, Landlord and Landlords employees and agents shall use commercially reasonable efforts to minimize interference with Tenants access to and use of the Premises during Tenants normal business hours.
(a) California Health and Safety Code Section 25359.7(b) requires any tenant of real property who knows, or has reasonable cause to believe, that any release of a Hazardous Substance, as defined below, has come to be located on or beneath such real property to give written notice of such condition to the owner. Tenant shall comply with the requirements of Section 25359.7(b) and any successor statute thereto and with all other Laws, and orders of governmental authorities with respect to Hazardous Substances. For purposes of this Section 8.05, Hazardous Substances shall mean and include those elements or compounds which are contained in the list of Hazardous Substances adopted by the United States Environmental Protection Agency (EPA) or in any list of toxic pollutants designated by Congress or the EPA or which are defined as hazardous, toxic, pollutant, infectious or radioactive by any other federal, state or local statute, law, ordinance, code, rule, regulation, order or decree regulating, relating to or imposing liability (including, without limitation, strict liability) or standards of conduct concerning, any hazardous, toxic or dangerous waste, substance or material, as now or at any time hereinafter in effect (collectively Environmental Laws). Landlord shall have the right to pursue all legal and equitable remedies available to it in the event of failure of Tenant to comply with the requirements of this Section 8.05.
(b) Tenant hereby agrees to indemnify Landlord and Landlords officers, directors, shareholders, managers, members, partners, agents, employees, servants, attorneys and representatives, as well as the respective heirs, personal representatives, successors and assigns of any and all of them (the Landlord Parties) and hold Landlord and Landlord Parties harmless from and against any and all losses, liabilities, including strict liability, damages, injuries, expenses, including reasonable attorneys fees, costs of settlement or judgment and claims of any and every kind whatsoever paid, incurred or suffered by, or asserted against, Landlord or Landlord Parties by
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any person, entity or governmental agency for, with respect to, or as a direct or indirect result of, the presence in, or the escape, leakage, spillage, discharge, emission or release from, the Premises of any Hazardous Substances caused by Tenant (including, without limitation, any losses, liabilities, including strict liability, damages, injuries, expenses, including reasonable attorneys fees, costs of any settlement or judgment or claims asserted or arising under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), any so-called federal, state or local Superfund or Superlien laws or any other Environmental Law); provided, however, that the foregoing indemnity is limited to matters arising solely from Tenants violation of the covenant contained in this Section 8.05, and shall not apply to Hazardous Substances present in the Building prior to the Effective Date of this Lease. The obligations of Tenant under this Article 8.05 shall survive any expiration or termination of this Lease.
(c) Landlord hereby agrees to indemnify Tenant and Tenants officers, directors, shareholders, managers, members, partners, agents, employees, servants, attorneys and representatives, as well as the respective heirs, personal representatives, successors and assigns of any and all of them (the Tenant Parties) and hold Tenant and Tenant Parties harmless from and against any and all losses, liabilities, including strict liability, damages, injuries, expenses, including reasonable attorneys fees, costs of settlement or judgment and claims of any and every kind whatsoever paid, incurred or suffered by, or asserted against, Tenant or Tenant Parties by any person, entity or governmental agency for, with respect to, or as a direct or indirect result of, the presence in, or the escape, leakage, spillage, discharge, emission or release from, the Building or Premises of any Hazardous Substances present in the Building prior to the Effective Date of this Lease.
ARTICLE 9SERVICES AND UTILITIES
9.01 General. During the Term of this Lease, Landlord shall:
(a) Operate or cause the operation in season of the heating, ventilating and air-conditioning (HVAC) system serving the Premises from 8:00 a.m. to 6:00 p.m., Monday through Friday, except for state and national holidays which are customarily observed in San Francisco, California (Ordinary Business Hours), at such temperatures and in such amounts as set forth in the Design Standards attached hereto as Exhibit D, subject to any applicable provisions of Title 24 of the California Code of Regulations or any similar governmental, municipal or public utility rules or regulations. Any HVAC provided by Landlord to Tenant during other than Ordinary Business Hours shall be furnished only upon at least twenty-four (24) hours prior written request of Tenant and Tenant shall pay Landlords customary charges for such services as set forth in Section 9.02. Should other tenants in the same HVAC zone which supplies the Premises also request HVAC during such period, then Tenants share of the charge for such HVAC shall be the fraction of the charge which the Rentable Area of the Premises bears to the total Rentable Area of the premises of other tenants within that HVAC zone so requesting and supplied HVAC. Tenant shall also be responsible for and shall pay Landlord any additional costs (including, without limitation, the costs of installation of additional HVAC equipment, if required by Landlord) incurred because of the failure of the HVAC system to perform its function due to (i) arrangement of partitioning in the Premises or changes or alterations thereto, (ii) or from any use of heat-generating machinery or equipment, or (iii) from occupancy of the Premises exceeding one person per one hundred (100) square feet of Rentable Area, or (iv) from failure of Tenant to keep all HVAC vents within the Premises free of obstruction. Tenant at all times agrees to cooperate fully with Landlord and to abide by the reasonable regulations and requirements which Landlord may prescribe for the proper functioning and protection of the HVAC system. Landlord, its contractors and agents throughout the Term, shall have free access to any and all mechanical installations of Landlord or Tenant, including, but not limited to, air-cooling, fan, ventilating and machine rooms and electrical and telephone closets; and Tenant agrees there shall be no construction of partitions or other obstructions which may interfere with Landlords free access thereto, or interfere with the moving of Landlords equipment to and from the enclosures containing such installations. Tenant further agrees that neither Tenant, nor its agents, employees or contractors shall at any time enter the said enclosures or tamper with, adjust or touch or otherwise in any manner affect such mechanical installations.
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(b) Provide access to water in the lavatories on each floor of the Building and, subject to any applicable provisions of Title 24 of the California Code of Regulations or any similar governmental, municipal or public utility rules or regulations governing energy consumption, make, or cause to be made, customary arrangements with public utilities and/or public agencies to furnish electric current to the Premises for Tenants use, in amounts sufficient for normal lighting by overhead fluorescent fixtures and for normal use of computers, computer networks (both wireless and wired), copy machines, facsimile machines and other office machines of similar electrical consumption, but not including electricity required for independent air-conditioning units, special communications equipment, special lighting or any other item of equipment which (singly) consumes more than one (1.0) kilowatt per hour at rated capacity or requires a voltage other than 120 volts single-phase (collectively High-Consumption Equipment). Tenant shall not install any High-Consumption Equipment in the Premises without Landlords written consent or otherwise exceed the electrical standards set forth on Exhibit D attached hereto. Landlord shall have no obligation to install dedicated circuits or other special circuitry or wiring. Tenant shall advise Landlord prior to execution of this Lease and within five (5) days after written request therefor of the nature and quantity of all lights, equipment and machines using electricity in the Premises and shall permit Landlord or its authorized agents to make periodic inspections of all facilities using electricity located within the Premises. If Landlord determines that Tenant is using electric current in excess of the amount required to be provided by Landlord pursuant to this Lease as described above, Landlord shall have the right to install an electric current meter in the Premises to measure the amount of electric current consumed on the Premises. The cost of such meter, special conduits, wiring and panels needed in connection therewith and the installation, maintenance and repair thereof shall be paid for by Tenant, and Tenant shall pay Landlord within fifteen (15) days following written demand from Landlord for all such costs, in addition to the costs of excess electric current as shown by such meter.
(c) Operate, maintain, clean, light, heat, ventilate and/or air-condition, as applicable, those portions of the Common Areas available for Tenant usage and provide such staffing and supervision as Landlord determines to be necessary. Tenant waives all claims against Landlord for losses due to theft or burglary, or for damages done by unauthorized persons in the Building who are not employed by any Landlord Party. Landlord shall provide passenger elevator service in the Building on a twenty-four (24) hours per day, seven (7) days per week basis. Landlord may limit elevator service during times other than Ordinary Business Hours.
(d) Provide janitorial service on each business day (exclusive of Saturdays, Sundays and legal or union holidays), subject to access being granted to the person or persons employed or retained by Landlord to perform such work. Landlord shall not be required to provide janitorial services for portions of the Premises used for preparing or consuming food or beverages, for storage, as a mailroom, or for a lavatory (other than the Common Area lavatory rooms).
(e) Subject to applicable laws and the other provisions of this Lease (including, without limitation, the Rules and Regulations attached hereto as Exhibit B and any reasonable modifications thereof adopted by Landlord from time to time in accordance with the terms of this Lease), Force Majeure, Landlords right to reasonably control access to the Building, and Section 9.04, Tenant shall have access to the Premises and Common Areas twenty-four (24) hours per day, seven (7) days per week, every day of the year.
(f) Landlord shall provide a level of security services for the Building which is comparable to the level of security services provided by owners of comparable first class office buildings in the San Francisco Financial District (Comparable Buildings). Notwithstanding Landlords agreement to provide such security services, Landlord shall in no event be liable for any claims, losses or damages in connection with the provision of, or failure to provide any such services, or the manner in which such services are provided.
(g) Landlord shall provide Building-standard suite-entry signage at the Premises and lobby directory listing.
9.02 Supplementary Services. Tenant shall pay Landlord, at the charges established by Landlord from time to time, for all supplementary services provided by Landlord or its agents to Tenant, which charges shall be
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payable by Tenant within thirty (30) days of demand by Landlord. Such supplementary services shall include, without limitation, freight elevator services on a first-come/first-serve basis (but no such charges for freight elevator will apply during Tenants move-in, maintenance, repair, janitorial, cleaning, HVAC and other services provided during hours other than Ordinary Business Hours and/or in amounts not considered by Landlord, in its commercially reasonable judgment, as standard (however, Landlord reserves the right to charge Tenant for loading dock security in accordance with Landlords Building-standard policies). Provided no Event of Default has occurred and is continuing, Tenant will not be charged for reasonable use of the freight elevator during Ordinary Business Hours during Tenants move into or move out of the Building.
9.03 Modification of Services. Landlord reserves the right, at any time and from time to time during the term, to modify, delete from or add to all or any of the services provided to Tenant hereunder so long as the services provided to Tenant hereunder are at least comparable, in quality and in type, to the services provided to tenants in other comparable high-rise office buildings in the San Francisco Financial District.
9.04 Interruption of Access, Use or Services. Landlord shall not be liable for any failure to provide access to the Premises, to assure the beneficial use of the Premises or to furnish any services or utilities when such failure is caused by natural occurrences, riots, civil disturbances, insurrection, war, court order, public enemy, accidents, breakage, repairs, strikes, lockouts, other labor disputes, the making of repairs, alterations or improvements to the Premises or the Building, the inability to obtain an adequate supply of fuel, gas, steam, water, electricity, labor or other supplies or by any other condition beyond Landlords reasonable control, and Tenant shall not be entitled to any damages resulting from such failure, nor shall such failure relieve Tenant of the obligation to pay all sums due hereunder or constitute or be construed as a constructive or other eviction of Tenant. If any governmental entity promulgates or revises any statute, ordinance or building, fire or other code, or imposes mandatory or voluntary controls or guidelines on Landlord or the Building or any part thereof, relating to the use or conservation of energy, water, gas, steam, light or electricity or the provision of any other utility or service provided with respect to this Lease, or if Landlord is required or elects to make alterations to the Building in order to comply with such mandatory or voluntary controls or guidelines, Landlord may, in its sole discretion, comply with such mandatory or voluntary controls or guidelines, or make such alterations to the Building; provided, however, that Landlord shall use commercially reasonable efforts to minimize interference with Tenants access to and use of the Premises during Tenants normal business hours in connection therewith. Neither such compliance nor the making of such alterations shall in any event entitle Tenant to any damages, relieve Tenant of the obligation to pay any of the sums due hereunder, or constitute or be construed as a constructive or other eviction of Tenant.
10.01 General. Except as contemplated in the Workletter attached hereto as Exhibit C, Tenant shall neither make nor cause to be made any alterations, additions or improvements (collectively such items made or installed after the Commencement Date are referred to as Alterations) in, on or to any portion of the Building or the Common Areas outside of the interior of the Premises. In the event of any conflict between the terms of Exhibit C and the terms of this Section 10.01 as they relate to the construction of the initial Tenant Improvements (as defined in Exhibit C), the terms of Exhibit C shall govern. Tenant shall not make or suffer to be made any Alterations in, on or to the Premises or any part thereof without the prior written consent of Landlord, which consent will not be unreasonably withheld beyond fifteen (15) business days; provided, however, Landlord may withhold its consent in its sole discretion if any proposed Alterations may adversely affect the structure or safety of the Building, the Buildings electrical, plumbing, HVAC, mechanical or life safety systems or may otherwise disturb any asbestos-containing materials. If such consent is granted, such Alterations must be made in compliance with this Article 10 and Section 16.02. When applying for any such consent, Tenant shall furnish complete plans and specifications for the desired Alterations, if the cost thereof is more than Twenty Thousand Dollars ($20,000) or if the proposed Alteration may affect the plumbing, electrical, HVAC, or structural systems of the Building or may otherwise disturb any asbestos-containing materials. Tenant need not obtain Landlords prior written approval for proposed purely cosmetic Alterations where the estimated
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cost is Twenty Thousand Dollars ($20,000) or less, provided that (i) such Alterations do not affect the structure or safety of the Building, the Buildings electrical, plumbing, HVAC, mechanical or life safety systems or may otherwise disturb any asbestos-containing materials, and (ii) Tenant provides Landlord with prior written notice of the nature and scope of the proposed Alterations as required in Section 10.02. If Landlord so requests, upon completion of such Alterations, Tenant shall furnish to Landlord as-built plans for such Alterations. Subsequent to obtaining Landlords consent and prior to commencement of construction of the Alterations, Tenant (a) shall deliver to Landlord, the building permit and a copy of the executed construction contract covering the Alterations, (b) shall, at its expense, obtain all permits, approvals and certificates required by governmental or quasi-governmental bodies, and (c) shall furnish to Landlord duplicate original policies of Workers Compensation (covering all persons to be employed by Tenant, and Tenants contractors and subcontractors in connection with such Alterations) and comprehensive public liability (including property damage coverage) insurance in such form, with such companies, for such periods and in such amounts (except that Workers Compensation shall be in statutory amounts) as Landlord reasonably may require, naming Landlord and its agents, any lessor under any Superior Lease and any mortgagee of a Mortgage (as such terms are hereinafter defined), as additional insureds. If any such Alterations involve disturbing any asbestos-containing materials, Tenant shall deliver to Landlord all necessary documentation relating to such work and the proper handling and disposal of such asbestos-containing materials. Tenant shall pay to Landlord upon demand a review fee (the Review Fee) in the amount of the higher of Two Hundred Dollars ($200) or three percent (3%) of the construction cost of the Alterations to compensate Landlord for the cost of review and approval of the plans and specifications and for additional administrative costs incurred in monitoring the construction of the Alterations, provided that Landlords construction review fee for the initial Tenant Improvements shall be as set forth in the Work Letter. If Landlord consents to the making of any Alterations, the same shall be made by Tenant at Tenants sole cost and expense; provided, however, that Tenants general contractor, subcontractor or persons selected by Tenant to make the same must first be approved in writing by Landlord. Tenant shall provide, at its expense, such completion, performance and/or payments bonds as Landlord considers in its commercially reasonable judgment necessary with respect to such construction work. Tenant shall also require its contractor to maintain insurance in amounts and in such form as Landlord may reasonably require and shall provide Landlord with a certificate of such policy before commencing any work at the Premises. Any construction, alteration, maintenance, repair, replacement, installation, removal or decoration undertaken by Tenant in connection with the Premises shall be completed in accordance with the plans and specifications approved by Landlord, shall be carried out in a good, workmanlike and prompt manner, designed and constructed in a first-class manner and shall comply with all applicable statutes, laws, ordinances, regulations, rules, orders and requirements of the authorities having jurisdiction thereof, shall be subject to supervision by Landlord or its employees, agents or contractors and shall be of equal or better quality than the then existing installation or Building Standard materials. Without Landlords prior written consent, Tenant shall not use any portion of the Common Areas in connection with the making of any Alterations. At Landlords option, Landlord may elect to construct the Alterations desired by Tenant. If Landlord so elects, Tenant shall reimburse Landlord for any and all costs thereof (including, without limitation, the costs of design, labor, materials and equipment) plus the Review Fee and a construction fee equal to the higher of Two Hundred Dollars ($200) or five percent (5%) of the total cost of construction of the Alterations, within thirty (30) days after receipt of Landlords invoice. Failure of Tenant to pay the invoiced costs within such thirty (30) day period shall constitute a default under the terms of this Lease in like manner as failure to pay rent when due. In the event of any such failure of Tenant to pay such costs when due, Landlord shall thereby be entitled without cost, obligation or liability of any kind or in any amount whatsoever, to discontinue the construction of any Alterations. Should Landlord elect to exercise such right to discontinue construction, Tenant shall be and remain liable to Landlord for any and all portions of the Alterations completed or partially completed at the time of the discontinuing of construction and for any additional items of loss, expense or damage incurred by Landlord. If the Alterations which Tenant causes to be constructed result in Landlord being required to make any alterations and/or improvements to other portions of the Building including structural members in order to comply with any applicable statutes, laws, ordinances, regulations, rules, orders or requirements (e.g. ordinances intended to provide full access to handicapped persons), then Tenant shall reimburse Landlord upon demand for all costs and expenses incurred by Landlord in making such alterations and/or improvements, provided that Landlord informs Tenant in advance of incurring
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such costs and obtains Tenants written instruction to go forward with the proposed Alterations. Any Alterations made by Tenant shall remain on and be surrendered with the Premises upon the expiration or sooner termination of the Term, except Tenant shall, upon demand by Landlord, at Tenants sole cost and expense, forthwith and with all due diligence remove (i) all or any portion of any Alterations made by Tenant which are not customary for general office use in a Class A office building, (ii) any Alterations for which no Landlord consent was required hereunder at the time of its installation, or (iii) any Alterations designated by Landlord to be removed at the time Landlord consented thereto, and Tenant shall forthwith and with all due diligence, and at its sole cost and expense, repair and restore the Premises (and any damage to the Building caused by such removal) to their original condition, reasonable wear and tear excepted.
10.02 Notice. If Landlord approves Tenants proposed Alterations, subsequent to Tenants receipt of such approval Tenant shall give Landlord at least fifteen (15) days prior written notice of commencement of any work of construction, alteration, maintenance, repair or replacement in order to enable Landlord to post and record notices of nonresponsibility. Tenant shall keep the Premises, Common Areas, Building and the real property upon which the Building is situated free from any liens or violations arising out of any work performed, materials furnished or obligations incurred by Tenant. If any such lien is placed upon the Building, Tenant shall within the later of (i) twenty (20) days of notice thereof and (ii) five (5) business days prior to when a lienholder could first file a legal action to realize on its rights under its lien, cause such lien to be discharged of record, by bonding or otherwise. If Tenant shall fail to cause any such lien to be discharged, Landlord shall have the right to have such lien discharged, and Landlords expense in so doing, including bond premiums, reasonable attorneys fees and filing fees, shall be immediately due and payable by Tenant.
10.03 Labor Relations. No construction, alteration, addition, improvement or decoration of the Premises by Tenant shall interfere with the harmonious labor relations in existence in the Building, and should such interference occur all such work shall be halted immediately by Tenant until such time as construction can proceed without any such interference.
10.04 Indemnity. Without limiting the generality of the provisions of Section 13.02 hereof, Tenant shall indemnify Landlord and Landlords Agent (as defined in Article l (b)) against any and all loss, cost, damage, injury and expense arising out of or in any way related to claims for work or labor performed, or materials or supplies furnished, to or at the request of Tenant or in connection with performance of any work done for the account of Tenant in the Premises, the Common Areas or the Building, whether or not Tenant obtained Landlords permission to have such work done, labor performed, or materials or supplies furnished.
10.05 Specialty Alterations. For purposes of this Lease the term Specialty Alterations shall mean Alterations consisting of the kitchen, executive bathrooms, raised computer floors, computer installations, data/telecommunications cabling and wiring, vaults, libraries, internal staircases, dumbwaiters and other Alterations of similar kind or character. Notwithstanding anything contained in this Article 10 to the contrary, Landlord, upon written notice to Tenant given at least thirty (30) days prior to the Expiration Date or earlier end of the Term, may require Tenant to remove any of Tenants Specialty Alterations, and to repair and restore in a good and workmanlike manner to Building standard condition (reasonable wear and tear excepted) any damage to the Premises or the Building caused by such removal.
10.06 Security System. Subject to applicable Laws, Tenant shall have the right to install, at Tenants sole cost and expense, a separate security system for the Premises (the Security System); provided, however, that the plans and specifications for any such system shall be subject to Landlords reasonable approval, and the installation of such system shall otherwise be subject to the terms and conditions of this Article 10. Tenant shall at all times provide Landlord and any applicable fire or other emergency response personnel with the necessary codes and/or keys to disarm the Security System and will provide Landlord with a contact (available on a 24/7 basis) who is familiar with the functions of the alarm system in the event of a malfunction. Tenant will remove all of those portions of the security system installed by Tenant in the Premises upon the expiration or earlier termination of this Lease and repair any and all damage to the Premises and Building caused by such removal in accordance with this Article 10.
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No representations, except as contained herein or endorsed hereon, have been made to Tenant respecting the condition of the Premises, and the acceptance of possession of the Premises by Tenant shall be conclusive evidence as against Tenant that the Premises are now in a tenantable and good condition. Tenant shall take good care of the Premises and shall make all repairs (within the Premises (specifically excluding any repairs to the Building exterior, the roof, the roof membrane, if applicable, the structure, foundation or walls of the Building or life safety, mechanical, electrical or other systems serving the Premises) as and when Landlord deems reasonably necessary in order to preserve the Premises in good working order and condition. In addition, Tenant shall reimburse Landlord, within thirty (30) days following written request therefore from Landlord, for the cost of any and all structural or nonstructural repairs, replacements or maintenance necessitated or occasioned by the acts, omissions or negligence of Tenant or any person claiming through or under Tenant, or any of their servants, employees, contractors, agents, visitors or licensees, or by the use or occupancy or manner of use or occupancy of the Premises by Tenant or any such person. Unless otherwise caused by the gross negligence or willful misconduct of Landlord and/or Landlord Parties, Landlord shall not be liable for, and there shall be no abatement of rent with respect to any injury to or interference with Tenants business arising from any repairs, maintenance, alteration or improvement in or to any portion of the Premises, the Common Areas or the Building or in or to the fixtures, appurtenances or equipment therein. Tenant hereby waives all right to make repairs at Landlords expense under the provisions of Sections 1932(1), 1941 and 1942 of the California Civil Code, and instead, all improvements, repairs and/or maintenance expenses incurred on the Premises shall be at the expense of Tenant, and shall be considered as part of the consideration for leasing the Premises. All damages or injury done to the Premises by Tenant or by any person who may be in or upon the Premises with Tenants consent or at Tenants invitation, shall be repaired with material of equal or better quality than the then existing installation of Building Standard materials paid for by Tenant, and Tenant shall, at the termination of this Lease, surrender the Premises to Landlord in as good condition and repair as when accepted by Tenant, reasonable wear and tear and damage by insured casualty excepted.
ARTICLE 12ASSIGNMENT AND SUBLETTING
12.01 General. Except as set forth in Section 12.07, Tenant shall not, without the prior written consent of Landlord, which consent shall not be unreasonably withheld, conditioned or delayed, provided Tenant complies with the terms and provisions of this Article 12: (a) assign, mortgage, pledge, encumber or otherwise transfer this Lease, the term or estate hereby granted, or any interest hereunder; (b) permit the Premises or any part thereof to be utilized by anyone other than Tenant (whether as concessionaire, franchisee, licensee, permittee or otherwise); or (c) except as hereinafter provided, sublet or offer or advertise for subletting the Premises or any part thereof (all of the foregoing, excluding transactions covered by Section 12.07 below, are hereinafter sometimes referred to collectively as Transfer and any person to whom any Transfer is made or sought to be made is hereinafter sometimes referred to as a Transferee). Subject to the provisions of this Lease and this Article 12, Landlord shall not withhold its consent to a proposed Transfer so long as no Event of Default (beyond any applicable notice and cure period hereunder) then exists, the use of the Premises by the proposed Transferee would be permitted under Section 8.01 hereof, and the proposed Transferee is of good business reputation and of sound financial condition, as reasonably determined by Landlord. Tenant acknowledges, however, that one or more existing or future mortgagees of a Mortgage affecting the Premises may have the right to approve any such Transfer, before Tenant may carry it out, and that, whenever such is the case, it shall be reasonable for Landlord to withhold its consent under this Section 12.01 to the Transfer if any such mortgagee withholds its consent thereto. Any Transfer without Landlords consent shall be voidable and, at Landlords election, shall constitute a default. The acceptance of any Monthly Base Rent or other payments by Landlord from a proposed Transferee shall not constitute consent to such Transfer by Landlord or a recognition of any Transferee, or a waiver by Landlord of any failure of Tenant or such other transferor to comply with the provisions of this Article 12. Except as set forth in Section 12.07, if Tenant is a corporation, any dissolution, merger, consolidation or other reorganization of Tenant, or the sale or other transfer of a controlling percentage of the capital stock of Tenant or the sale of fifty percent (50%) or more of the value of the assets of Tenant, shall be deemed a voluntary
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assignment of this Lease by Tenant. The phrase controlling percentage shall mean the ownership of, and the right to vote, stock possessing fifty percent (50%) or more of the total combined voting power of all classes of Tenants capital stock issued, outstanding, and entitled to vote for the election of directors. The preceding two sentences shall not apply to corporations, the stock of which is traded through an exchange or over the counter. Except as set forth in Section 12.07, if Tenant is a partnership, a withdrawal or change, voluntary, involuntary, or by operation of law of any partner or partners owning a total of fifty percent (50%) or more of the partnership, or the dissolution of the partnership, shall be deemed a voluntary assignment of this Lease by Tenant. If Tenant consists of more than one person, a purported assignment, voluntary, involuntary, or by operation of law, by any one of the persons executing this Lease shall be deemed a voluntary assignment of this Lease by Tenant. Except as set forth in Section 12.07, if Tenant assigns this Lease, or sublets all or a portion of the Premises, or requests the consent of Landlord to any Transfer, or if Tenant requests the consent of Landlord for any act that Tenant proposes to do pursuant to this Lease which requires Landlords consent, then Tenant shall pay Landlords reasonable processing fee (not to exceed $1,500 per request) and shall reimburse Landlord for all reasonable attorneys fees incurred in connection therewith.
12.02 Notice and Procedure. If at any time or from time to time during the Term, Tenant desires to Transfer all or any part of the Premises (except as set forth in Section 12.07) then at least fifteen (15) days, but not more than one hundred twenty (120) days, prior to the date when Tenant desires the Transfer to be effective (the Transfer Date), Tenant shall give Landlord a notice (the Transfer Notice) which shall set forth the name, address and business of the proposed Transferee, information (including financial statements and references) concerning the character of the proposed Transferee, a detailed description of the space proposed to be Transferred (the Transfer Space), any rights of the proposed Transferee to use Tenants improvements and the like, the Transfer Date, the proposed use for the Transfer Space, the term and the fixed rent and/or other consideration and all other material terms and conditions of the proposed Transfer, all in such detail as Landlord may reasonably require. If Landlord reasonably requests additional detail, the Transfer Notice shall not be deemed to have been received until Landlord receives such additional detail. Landlord shall have the option, exercisable by giving notice to Tenant at any time within twenty (20) days after Landlords receipt of the Transfer Notice (a) in the case of a Transfer (other than a sublease or transactions covered by Section 12.07), to terminate this Lease as to the Transfer Space as of the Transfer Date set forth in Landlords notice, in which event Tenant shall be relieved of all further obligations hereunder as to the Transfer Space as of the Transfer Date; or (b) in the case of a sublease other than as covered by Section 12.07, to sublease the Transfer Space from Tenant upon the terms and conditions set forth in the Transfer Notice. If Landlord exercises its option to sublet the Transfer Space, Tenant shall sublet the Transfer Space to Landlord upon the terms and conditions contained in the Transfer Notice; provided, however, that: (i) Landlord shall at all times under such sublease have the right and option further to sublet the Transfer Space without obtaining Tenants consent or sharing any of the economic consideration received by Landlord in which event Tenant shall be relieved of all further obligations hereunder as to the Transfer Space as of the date of such further sublease (but only during the term of such further sublease); (ii) the provisions of Article 8 shall not be applicable thereto; (iii) Landlord and its tenants shall have the right to use in common with Tenant all lavatories, corridors and lobbies which are within the Premises and the use of which is reasonably required for the use of the Transfer Space; (iv) Tenant shall have no right of setoff or abatement or any other right to assert a default hereunder by reason of any default by Landlord under such sublease; and (v) Landlords liability under such sublease shall not be deemed assumed or taken subject to by any successor to Landlords interest under this Lease. No failure of Landlord to exercise either option with respect to the Transfer Space shall be deemed to be Landlords consent to the Transfer of all or any portion of the Transfer Space. If Landlord does not exercise either option, Tenant shall be free to Transfer the Transfer Space to any entity or person upon receipt of Landlords prior written consent, which cannot be unreasonably withheld, conditioned, or delayed but only if Tenants proposed Transfer complies with the terms and provisions of this Article 12 and each of the following conditions:
(a) No Event of Default beyond any applicable notice and cure period hereunder then exists under this Lease;
(b) The Transfer shall be on the same terms set forth in the Transfer Notice given to Landlord;
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(c) No Transfer shall be valid, and no Transferee shall take possession of the Transfer Space, until an executed counterpart of the Transfer has been delivered to Landlord;
(d) No Transferee shall have a right further to Transfer without the consent of Landlord (which may be withheld or conditioned in Landlords sole and absolute discretion);
(e) Any proposed subletting would not result in more than two subleases of portions of the Premises being in effect at any one time during the Term;
(f) [Intentionally Deleted];
(g) No Transferee shall be an existing tenant in the Building unless Landlord does not have a comparable amount of space in the Building then available for direct lease;
(h) No Transferee shall be a governmental entity or otherwise immune from the jurisdiction of the courts of the State of California;
(i) No proposed Transfer would result in an increase in the number of people in excess of one person per each 225 rentable square feet in the Premises, or would cause an increase in Landlords Direct Expenses over the amount of such Direct Expenses existing prior to such Transfer unless such proposed Transferee agrees to pay such increase in Direct Expenses.
12.03 Continuing Liability of Tenant. Regardless of Landlords consent, no Transfer shall release Tenants obligation or alter the primary liability of Tenant to pay the rent and to perform all other obligations to be performed by Tenant hereunder. The acceptance of rent by Landlord from any other person shall not be deemed to be a waiver by Landlord of any provision hereof. Consent to one Transfer shall not be deemed consent to any subsequent Transfer. If any assignee of Tenant or any successor of Tenant defaults in the performance of any of the terms hereof, Landlord may proceed directly against Tenant without the necessity of exhausting remedies against such assignee or successor. Landlord may consent to subsequent Transfers of this Lease or amendments or modifications to this Lease with assignees of Tenant, without notifying Tenant, or any successor of Tenant, and without obtaining its or their consent thereto, and such action shall not relieve Tenant of its liability under this Lease.
12.04 Bankruptcy. If a petition is filed by or against Tenant for relief under Title 11 of the United States Code, as amended (the Bankruptcy Code), and Tenant (including for purposes of this Section 12.04 Tenants successor in bankruptcy, whether a trustee or Tenant as debtor in possession) assumes and proposes to assign, or proposes to assume and assign, this Lease pursuant to the provisions of the Bankruptcy Code to any person or entity who has made or accepted a bona fide offer to accept an assignment of this Lease on terms acceptable to Tenant, then notice of the proposed assignment setting forth (a) the name and address of the proposed assignee, (b) all of the terms and conditions of the offer and proposed assignment, and (c) the adequate assurance to be furnished by the proposed assignee of its future performance under the Lease, shall be given to Landlord by Tenant no later than twenty (20) days after Tenant has made or received such offer, but in no event later than ten (10) days prior to the date on which Tenant applies to a court of competent jurisdiction for authority and approval to enter into the proposed assignment. Landlord shall have the prior right and option, to be exercised by notice to Tenant given at any time prior to the date on which the court order authorizing such assignment becomes final and nonappealable, to receive an assignment of this Lease upon the same terms and conditions, and for the same consideration, if any, as the proposed assignee, less any brokerage commissions which may otherwise be payable out of the consideration to be paid by the proposed assignee for the assignment of this Lease. If this Lease is assigned pursuant to the provisions of the Bankruptcy Code, Landlord: (i) may require from the assignee a deposit or other security for the performance of its obligations under the Lease in an amount substantially the same as would have been required by Landlord upon the initial leasing to a tenant similar to the assignee; and (ii) shall receive, as additional rent, the sums and economic consideration described in Section 12.05. Any person or entity to which this Lease is assigned pursuant to the provisions of the Bankruptcy Code shall be deemed, without further act or documentation, to have assumed all of the Tenants obligations arising under this Lease on and after the date of such assignment. Any such assignee shall, upon demand, execute and deliver to Landlord an instrument confirming such assumption. No provision of this Lease shall be deemed a waiver of Landlords
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rights or remedies under the Bankruptcy Code to oppose any assumption and/or assignment of this Lease, to require a timely performance of Tenants obligations under this Lease, or to regain possession of the Premises if this Lease has neither been assumed nor rejected within sixty (60) days after the date of the order for relief or within such additional time as a court of competent jurisdiction may have fixed. Notwithstanding anything in this Lease to the contrary, all amounts payable by Tenant to or on behalf of Landlord under this Lease, whether or not expressly denominated as rent, shall constitute rent for the purposes of Section 502(b)(6) of the Bankruptcy Code.
12.05 Transfer Premium. If Landlord consents to a Transfer, as a condition thereto which the parties hereby agree is reasonable, Tenant shall pay to Landlord fifty percent (50%) of any Transfer Premium, as that term is defined in this Section 12.05, received by Tenant from such Transferee. Transfer Premium shall mean all rent, additional rent, and other consideration received from such Transferee in excess of the rent, additional rent and other consideration payable by Tenant under this Lease on a per rentable square foot basis if less than all of the Premises is transferred, after deducting the actual, reasonable and documented expenses incurred by Tenant for (i) any changes, alterations and improvements made to the Premises (whether hard or soft costs) and/or any tenant improvement allowance or other commercially reasonable concession provided by Tenant to the Transferee, in connection with the Transfer, (ii) any brokerage commissions and advertising and marketing expenses in connection with the Transfer, (iii) reasonable legal fees incurred by Tenant in negotiating the Transfer and obtaining Landlords consent thereto, and (iv) any fees, costs, expenses and charges paid to Landlord for consent or review of the proposed Transfer. The Transfer Premium shall not apply to any Transfer to an Affiliate. Transfer Premium shall also include, but not be limited to, key money and bonus money paid by Transferee to Tenant in connection with such Transfer, and any payment in excess of fair market value for services rendered by Tenant to the Transferee in connection with such Transfer.
12.06 Limitation on Remedies. Tenant shall not be entitled to make, nor shall Tenant make, any claim, and Tenant by this Section 12.05 waives any claim, for money damages (nor shall Tenant claim any money damages by way of set-off, counterclaim or defense) based upon any claim or assertion by Tenant that Landlord has unreasonably withheld or unreasonably delayed its consent or approval to a proposed Transfer as provided for in this Article 12. Tenants sole and exclusive remedy shall be an action or proceeding to enforce any such provision, or for specific performance, injunctive relief or declaratory judgment. Tenant acknowledges that Tenants rights under this Article 12 satisfy the conditions set forth in Section 1951.4 of the California Civil Code with respect to the availability to Landlord of certain remedies for a default by Tenant under this Lease.
12.07 Non-Transfers. Notwithstanding anything to the contrary contained in this Lease, none of (i) an assignment to a transferee of all or substantially all of the stock (or interests) or assets of Tenant, (ii) the sale or other transfer of a controlling percentage of the capital stock of Tenant or the sale of fifty percent (50%) or more of the value of the assets of Tenant, (iii) an assignment of the Premises to a transferee which is the resulting entity of a merger or consolidation of Tenant with another entity, (iv) an assignment or subletting of all or a portion of the Premises to an Affiliate of Tenant (which term is defined to mean an entity which is controlled by, controls, or is under common control with, Tenant), and (v) a sale or transfer of the memberships, interests or stock if (1) such sale or transfer occurs in connection with any bona fide financing or capitalization for which Tenant receives substantially all the proceeds thereof, or (2) Tenant is, or in connection with the proposed transfer becomes, a publicly traded entity, shall be deemed a Transfer under Article 12 of this Lease (and no Transfer Premium shall be payable to Landlord in connection therewith), provided that Tenant notifies Landlord of any such assignment or sublease within twenty (20) days after such assignment or subletting and promptly supplies Landlord with any documents or information reasonably requested by Landlord regarding such transfer or transferee as set forth in items (i) through (iv) above, that such assignment or sublease is not a subterfuge by Tenant to avoid its obligations under this Lease and that such transferee or Affiliate shall have a net worth (not including goodwill as an asset) computed in accordance with generally accepted accounting principles (the Net Worth) in an amount which is at least $35,000,000. Control, as used in this Section 12.07, shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a person or entity, whether by the ownership of voting securities, by contract or otherwise.
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ARTICLE 13INDEMNIFICATION AND LANDLORD LIABILITY
13.01 Waiver of Liability. Neither Landlord nor any of the Landlord Parties nor any Superior Lessor (as hereinafter defined) (collectively, the Indemnitees) shall be liable or responsible in any way for, and Tenant hereby waives all claims against the Indemnitees with respect to or arising out of: any death or any injury of any nature whatsoever that may be suffered or sustained by Tenant or any Tenant Parties or any other person, from any causes whatsoever (except to the extent caused by the willful misconduct or gross negligence of an Indemnitee); or for any loss or damage or injury to any property outside or within the Premises belonging to Tenant or the Tenant Parties or any other person, unless such injury or damage is to property not covered by insurance carried by Tenant and is caused solely by the gross negligence or willful misconduct of the Indemnitees. Without limiting the generality of the foregoing, none of the Indemnitees shall be liable for any damage or damages of any nature whatsoever to persons or property caused by explosion, fire, theft or breakage, by sprinkler, drainage or plumbing systems, by failure for any cause to supply adequate drainage, by the interruption of any public utility or service, by steam, gas, water, rain or other substances leaking, issuing or flowing into any part of the Premises, by natural occurrence, acts of the public enemy, riot, strike, insurrection, war, court order, requisition or order of governmental body or authority, or for any damage or inconvenience which may arise through repair, maintenance or alteration of any part of the Building, or by anything done or omitted to be done by any tenant, occupant or person in the Building. In addition, none of the Indemnitees shall be liable for (i) any loss or damage for which the Tenant is required to insure, nor for any loss or damage resulting from any construction, alterations or repair or (ii) any consequential, punitive, exemplary, speculative, treble or other similar measure of damages.
13.02 Indemnity. Tenant shall hold the Indemnitees harmless and defend the Indemnitees from and against any and all losses, damages, claims, or liability for any damage to any property or injury, illness or death of any person: (a) occurring in, on, or about the Premises, or any part thereof, arising at any time and from any cause whatsoever other than to the extent caused by gross negligence or willful misconduct of the Indemnitees, their employees or agents; and (b) occurring in, on, or about any part of the Building other than the Premises, to the extent such damage, injury, illness or death shall be caused by the negligence or willful misconduct of Tenant or the Tenant Parties. The provisions of this Article 13 shall survive the termination of this Lease with respect to any damage, injury, illness or death occurring prior to such termination. References herein to the Indemnitees shall include their respective agents and employees.
13.03 Landlord Liability. Neither Landlords Agent nor the Landlord Parties shall be liable for the performance of Landlords obligations under this Lease. Tenant shall look solely to Landlord to enforce Landlords obligations hereunder and shall not seek any damages against any of the Landlord Parties. The liability of Landlord for Landlords obligations under this Lease shall not exceed and shall be limited to Landlords interest in the Building and Tenant shall not look to the property or assets of any of the Landlord Parties in seeking either to enforce Landlords obligations under this Lease or to satisfy a judgment for Landlords failure to perform such obligations.
13.04 Consequential Damages. Notwithstanding anything to the contrary contained in this Lease, nothing in this Lease shall impose any obligations on Tenant or Landlord to be responsible or liable for, and each hereby releases the other from all liability for, consequential damages other than those consequential damages incurred by Landlord in connection with a holdover of the Premises by Tenant after the expiration or earlier termination of this Lease.
ARTICLE 14DESTRUCTION OR DAMAGE
In the event of a fire or other casualty in the Premises, as soon as Tenant becomes aware, Tenant shall immediately give notice thereof to Landlord. The following provisions shall apply to fire or other casualty occurring in the Premises and/or the Building:
(a) If the damage is limited solely to the Premises and the Premises can be made tenantable with all damage repaired within six (6) months from the date of damage or destruction, then Landlord shall be
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obligated to rebuild the same excluding Tenants Specialty Alterations, if any, and shall proceed diligently to do so; provided, however, that Landlord shall have no obligation to repair or restore Tenant Improvements installed in the Premises by Tenant or by Landlord except to the extent that Landlord has received insurance proceeds from either Landlords or Tenants casualty insurer, sufficient for such purposes and for all other restoration and repair purposes or unless Tenant pays all costs and expenses related to the reconstruction of uninsured or underinsured Tenant Improvements.
(b) If portions of the Building outside the boundaries of the Premises are damaged or destroyed (whether or not the Premises are also damaged or destroyed) and the Premises and the Building can both be made tenantable with all damage repaired within nine (9) months from the date of damage or destruction, and provided that Landlord determines that it is economically feasible, Landlord shall be obligated to do so; provided, however, that Landlord shall have no obligation to repair or restore improvements installed in the Premises by Tenant except to the extent that Landlord receives insurance proceeds sufficient for such purpose and for all other restoration and repair purposes.
(c) If neither clause (a) nor (b) above applies, Landlord shall notify Tenant within sixty (60) days after the date such damage or destruction is adjusted by Landlord and Landlords casualty insurer and either Tenant or Landlord may terminate this Lease within thirty (30) days after the date of such notice; provided, however, that Landlord shall have the right to elect to reconstruct the Building and the Premises, in which event Landlord shall notify Tenant within such sixty (60) day period and Tenant shall thereupon have no right to terminate this Lease, except as expressly set forth below.
(d) During any period when the Premises, as a result of destruction or damage, are unusable and are actually unused by Tenant, rent shall abate proportionately, as reasonably determined by Landlord in good faith, on a day for day basis, until such time as the Premises are made tenantable, and no portion of the rent so abated shall be subject to subsequent recapture; provided, however, that there shall be no such abatement except to the extent that the amount thereof is compensated for and recoverable from the proceeds of rental abatement or business interruption insurance maintained by Landlord with respect to this Lease, the Premises or the Building. In addition, there shall be no abatement of rent attributable to the time period following the repair of damage to the Premises by the Landlord where the Premises would have been otherwise reasonably deemed available for Tenants occupancy, except for reconstruction of the Tenant Improvements where such reconstruction did not or has not occurred because of the failure of Tenant to pay to Landlord, or cause to be paid to Landlord, prior to the commencement of the anticipated repairs and reconstruction, an amount sufficient to pay for the cost of the anticipated repair and/or reconstruction or because of any other delays caused by Tenant.
(e) The proceeds from any insurance paid by reason of damage to or destruction of the Building or any part thereof, insured by Landlord, shall belong to and be paid to Landlord subject to the rights of any Superior Lessor or any mortgagee of any Mortgage which constitutes an encumbrance.
(f) Tenant waives California Civil Code Sections 1932(2) and 1933(4) providing for termination of hiring upon destruction of the thing hired.
(g) Notwithstanding the foregoing, Landlord shall have no obligation to rebuild the Premises in the event of damage or destruction of the Premises occurring during the last two (2) years of the Term (excluding unexercised options).
(h) Notwithstanding the foregoing, Tenant shall have the right to terminate this Lease by written notice to Landlord in the event that the Premises are damaged to the extent that Tenants use of the entire Premises is materially impaired, and the restoration of the Premises is not substantially completed within one hundred eighty (180) days of the date of the casualty.
(i) In the event that the Premises or the Building is destroyed or damaged to any substantial extent during the last eighteen (18) months of the Term, and, in the reasonable opinion of Landlord, the damage or destruction to the Premises or Building cannot be repaired by the date which is six (6) months prior to the Expiration Date, then notwithstanding anything contained in this Article, either Landlord or Tenant shall
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have the option to terminate this Lease by giving written notice to the other party of the exercise of such option within thirty (30) days after such damage or destruction, in which event this Lease shall cease and terminate as of the date of such notice, Tenant shall pay the Base Rent and Additional Rent, properly apportioned up to such date of damage, and both parties hereto shall thereafter be freed and discharged of all further obligations hereunder, except as provided for in provisions of this Lease which by their terms survive the expiration or earlier termination of the Term.
ARTICLE 15WAIVER OF SUBROGATION
Tenant and Landlord agree that insurance required to be carried by either of them against loss or damage by fire or other casualty shall contain a clause whereby the insurer waives its rights to subrogation against the other party, its agents, officers and employees for any loss or damage to its property or to the property of others covered by insurance. As long as such waivers of subrogation are contained in their respective insurance policies, Landlord and Tenant hereby waive any right that either may have against the other on account of any loss or damage to their respective property to the extent such loss or damage is insurable under policies of insurance for fire and all risk coverage, theft, public liability, or other similar insurance.
ARTICLE 16RULES AND REGULATIONS
16.01 Rules and Regulations. Tenant shall faithfully observe and comply with the Rules and Regulations of the Building now in effect, a copy of which is attached hereto as Exhibit B and, after notice thereof, all reasonable modifications thereof and additions thereto from time to time promulgated in writing by Landlord, all of which are hereby incorporated herein by this reference. Landlord shall apply the Rules and Regulations of the Building in a professional, good faith manner. Landlord shall not be responsible to Tenant for the nonperformance by any other tenant or occupant of the Building of any of the Rules and Regulations. In the event of a conflict between the Rules and Regulations and the provisions of this Lease, this Lease shall govern.
16.02 Certain Fireproofing and Insulating Materials. Tenant acknowledges that certain fire-proofing and insulating materials used in the construction of the Building contain asbestos and other hazardous substances (collectively asbestos). If any governmental entity promulgates or revises a statute, ordinance, code, rule or regulation, or imposes mandatory or voluntary controls or guidelines with respect to such asbestos-containing materials or if Landlord otherwise so elects, Landlord may, in its sole discretion, comply with such mandatory or voluntary controls or guidelines, or elect to make such alterations or remove such asbestos-containing materials; provided that Rent shall abate in proportion to the extent to which Landlords work in the Premises materially interferes with Tenants use. Such compliance or the making of alterations, and the removal of all or a portion of such asbestos-containing materials, whether in the Premises or elsewhere in the Building, shall not, in any event constitute a breach by Landlord of any provision of this Lease, relieve Tenant of the obligation to pay any rent due under this Lease, constitute or be construed as a constructive or other eviction of Tenant, or constitute or be construed as a breach of Tenants quiet enjoyment.
16.03 Asbestos. Landlord has advised Tenant that there is asbestos-containing material (ACM) in the Building. Attached hereto as Exhibit F is a disclosure statement regarding ACM in the Building. Tenant acknowledges that such notice complies with the requirements of Section 25915 et seq. and Section 25359.7 of the California Health and Safety Code.
17.01 Entry to the Premises. Landlord, its agents, contractors or employees may enter the Premises at reasonable hours to: (a) inspect the same; (b) exhibit the same to Superior Lessors, prospective purchasers,
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lenders or (during the last six (6) months of the Term) to tenants; (c) determine whether Tenant is complying with all of its obligations hereunder; (d) supply janitorial service and any other service to be provided by Landlord to Tenant hereunder or to any other tenant of the Building; (e) post notices of nonresponsibility; and (f) make repairs required of Landlord under the terms hereof or which Landlord deems necessary or desirable or make repairs to any adjoining space or utility services or make repairs, alterations or improvements to any other portion of the Building; provided, however, that all such work shall be done as promptly as reasonably possible and so as to cause as little interference to Tenant as reasonably possible. Landlord agrees to use commercially reasonable efforts to give one (1) business days prior notice (which may be oral or delivered by email) with respect to (b) above. Provided Tenant is not then in default hereunder, with all notices having been given and all cure periods having lapsed, when Landlord exercises its entry rights hereunder, Landlord and any invitees permitted hereunder shall check-in with Tenants receptionist, and Tenant shall have the right to accompany Landlord. Except to the extent caused by the active negligence or willful misconduct of Landlord, Tenant hereby waives any claim for damages for any injury or inconvenience to or interference with Tenants business, any loss of occupancy or quiet enjoyment of the Premises, and any other loss occasioned by such entry. Landlord shall at all times have and retain a key with which to unlock all of the doors in, on or about the Premises (excluding Tenants vaults, safes and similar areas agreed upon in writing by Tenant and Landlord). Landlord shall have the right to use any and all means which Landlord may deem proper to open such doors in an emergency in order to obtain entry to the Premises, and no entry to the Premises obtained by Landlord by any of such means shall under any circumstance be construed or deemed to be a forcible or unlawful entry into, or a detainer of, the Premises or an eviction, actual or constructive, of Tenant from the Premises, or any portion thereof.
17.02 Alterations to Building. Landlord shall have the right from time to time to alter the Building and, without the same constituting an actual or constructive eviction and without incurring any liability to Tenant therefor, to change the arrangement or location of entrances or passageways, doors and doorways, and corridors, elevators, stairs, toilets, or other public parts of the Building and to change the name, number or designation by which the Building is commonly known, provided any such change does not (a) unreasonably reduce, interfere with or deprive Tenant of access to the Building or Premises or (b) reduce the Rentable Area (except by a de minimis amount) of the Premises. All parts (except surfaces facing the interior of the Premises) of all walls, windows and doors bounding the Premises (including exterior Building walls, exterior core corridor walls, exterior doors and entrances), all balconies, terraces and roofs adjacent to the Premises, all space in or adjacent to the Premises used for shafts, stacks, stairways, chutes, pipes, conduits, ducts, fan rooms, heating, air cooling, plumbing and other mechanical facilities, service closets and other Building facilities are not part of the Premises, and Landlord shall have the use thereof, as well as access thereto through the Premises for the purposes of operation, maintenance, alteration and repair.
18.01 Events of Default. In addition to any other event specified in this Lease as an event of default, the occurrence of any one or more of the following events (Events of Default) shall constitute a breach of this Lease by Tenant: (a) abandonment of the Premises for a continuous period in excess often (10) business days; (b) failure by Tenant to pay any rent, including Tenants Percentage Share of Increased Direct Expenses and Increased Taxes, when and as the same becomes due and payable which failure continues for three (3) calendar days after written notice thereof from Landlord; (c) failure by Tenant to pay any other sum when and as the same becomes due and payable if such failure continues for more than ten (10) days after written notice thereof from Landlord; (d) failure by Tenant to comply with Section 25.01 or Article 28; (e) failure by Tenant to perform or observe any other obligations of Tenant hereunder, or to comply with the Rules and Regulations described in Article 16, if such failure continues for more than ten (10) days after written notice thereof from Landlord, unless such default cannot reasonably be cured within such ten (10) day period and Tenant shall within such period commence with due diligence and dispatch the curing of such default, and, having so commenced, shall thereafter prosecute or complete with due diligence and dispatch the curing of such default; (f) the making by Tenant of a general assignment for the benefit of creditors, or the admission of its inability to pay its debts as they become due or the filing of a petition, case or proceeding in bankruptcy, or the adjudication of Tenant
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bankrupt or insolvent, or the filing of a petition seeking any reorganization, arrangement, composition, readjustment, liquidation, dissolution or similar relief under any present or future statute, law or regulation, or the filing of an answer admitting or failing reasonably to contest the material allegations of a petition filed against it in any such proceeding, or the seeking or consenting to or acquiescence in the appointment of any trustee, receiver or liquidator of Tenant or any material part of its properties; (g) if within ninety (90) days after the commencement of any proceeding against Tenant seeking any reorganization, arrangement, composition, readjustment, liquidation, dissolution or similar relief under any present or future statute, law or regulation, such proceeding shall not have been dismissed, or if, within ninety (90) days after the appointment without the consent or acquiescence of Tenant, of any trustee, receiver or liquidator of Tenant or of any material part of its properties, such appointment shall not have been vacated; or (h) if this Lease or any estate of Tenant hereunder shall be levied upon under any attachment or execution and such attachment or execution is not vacated within ten (10) days. All written notices under this Section 18.01 may be delivered to and served upon Tenant in the manner, form and substance specified in California Code of Civil Procedure Section 1161 et seq., and Tenant shall not be entitled to any subsequent notices thereunder.
18.02 Landlords Remedies. If an Event of Default shall occur, Landlord at any time thereafter may give a written termination notice to Tenant, and on the date specified in such notice (which shall be not less than three (3) days after the giving of such notice), Tenants right to possession shall terminate and this Lease shall terminate, unless on or before such date all arrears of rent and all other sums payable by Tenant under this Lease (together with interest thereon at the rate set forth in Section 18.04 hereof) and all costs and expenses incurred by or on behalf of Landlord hereunder shall have been paid by Tenant and all other breaches of this Lease by Tenant at the time existing shall have been fully remedied to the satisfaction of Landlord. Should Landlord terminate this Lease pursuant to the provisions of this Section, Landlord shall have all the rights and remedies of a landlord provided by Section 1951.2 of the California Civil Code or any successor code section. Upon such termination, in addition to any other rights and remedies to which Landlord may be entitled under applicable law, Landlord may recover from Tenant: (a) the worth at the time of award of the unpaid rent which had been earned at the time of termination; (b) the worth at the time of award of the amount by which the unpaid rent which would have been earned after termination until the time of award exceeds the amount of such rent loss that Tenant proves could have been reasonably avoided; (c) the worth at the time of award of the amount by which the unpaid rent for the balance of the term of this Lease after the time of award exceeds the amount of such rent loss that Tenant proves could be reasonably avoided; and (d) any other amount necessary to compensate Landlord for all the detriment proximately caused by Tenants failure to perform its obligations under this Lease or which in the ordinary course of things would be likely to result therefrom. The worth at the time of award of the amounts referred to in clauses (a) and (b) above shall be computed by allowing interest at the rate set forth in Section 18.04 hereof. The worth at the time of award of the amount referred to in clause (c) above shall be computed by discounting such amount at a rate equal to the discount rate of the Federal Reserve Bank of San Francisco at the time of award plus one percentage point.
18.03 Rent Computation. For purposes of computing unpaid rent which would have accrued and become payable under this Lease, unpaid rent shall consist of the sum of:
(a) the total Monthly Base Rent for the balance of the Term; plus
(b) Tenants Percentage Share of Increased Direct Expenses and Increased Taxes for the balance of the Term. For purposes of computing Increased Direct Expenses the Direct Expenses for the calendar year of the default and each future calendar year in the Term shall be assumed to be equal to the Direct Expenses for the calendar year prior to the year in which default occurs compounded at a rate equal to the mean average rate of inflation for the three (3) calendar years preceding the calendar year of the default, as determined by using the United States Department of Labor, Bureau of Labor Statistics Consumer Price Index (All Urban Consumers, All Items, 1982-84 equals 100) for the metropolitan area or region of which San Francisco, California is a part. If such index is discontinued or revised, the average rate of inflation shall be determined by reference to the index designated as the successor or substitute index by the government of the United States.
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18.04 Interest. Every installment of rent and every other payment due hereunder from Tenant to Landlord which shall not be paid when the same shall have become due and payable shall bear interest at the rate of two percent (2%) over the Prime Rate, or at the highest rate legally permitted, whichever is less, from the date that the same became due and payable until paid, whether or not demand be made therefor.
18.05 Late Charges. Tenant acknowledges that late payment by Tenant to Landlord of Monthly Base Rent or Increased Direct Expenses or Increased Taxes will cause Landlord to incur costs not contemplated by this Lease, the exact amount of such costs being extremely difficult and impracticable to fix. Such costs include, without limitation, processing and accounting charges, and late charges that may be imposed on Landlord by the terms of any note secured by an encumbrance covering the Premises. Therefore, if any installment of Monthly Base Rent or Increased Direct Expenses or Increased Taxes due from Tenant is not received by Landlord when due, Tenant shall pay to Landlord on demand an additional sum equal to five percent (5%) of the overdue amount as a late charge. The parties agree that this late charge represents a fair and reasonable estimate of the costs that Landlord will incur by reason of such late payment by Tenant. Acceptance of any late charge shall not constitute a waiver of Tenants default with respect to the overdue amount, or prevent Landlord from exercising any of the other rights and remedies available to Landlord.
18.06 Lease Continues Until Termination. If Tenant has breached this Lease and abandoned the Premises, Landlord may elect to exercise its rights pursuant to California Civil Code Section 1951.4 (lessor may continue lease in effect after lessees breach and abandonment and recover Rent as it becomes due, if lessee has the right to sublet or assign, subject only to reasonable limitations) and to continue this Lease in effect for so long as Landlord does not terminate Tenants right to possession, and Landlord may enforce all its rights and remedies under this Lease, including the right to recover the rent as it becomes due under this Lease. Acts of maintenance or preservation or efforts to relet the Premises or the appointment of a receiver upon initiative of Landlord to protect Landlords interest under this Lease shall not constitute a termination of Tenants right to possession.
18.07 Remedies Cumulative. The remedies provided for in this Lease are in addition to any other remedies available to Landlord at law or in equity by statute or otherwise.
18.08 Waiver of Redemption. Tenant hereby waives, for itself and all persons claiming by and under Tenant, all rights and privileges which it might have under California Code of Civil Procedure Section 1179 and any present or future law to redeem the Premises or to continue the Lease after being disposed or ejected from the Premises.
ARTICLE 19LANDLORDS RIGHT TO CURE DEFAULTS
All agreements and provisions to be performed by Tenant under any of the terms of this Lease shall be at Tenants sole cost and expense and without any abatement of rent. If Tenant shall fail to pay any sum of money, other than Monthly Base Rent, required to be paid by it hereunder or shall fail to cure any default and such failure shall continue for ten (10) days after notice thereof by Landlord, then Landlord may, but shall not be obligated so to do, and without waiving or releasing Tenant from any obligations, make any such payment or perform any such act on Tenants part. All sums so paid by Landlord and all costs incurred by Landlord in taking such action shall be deemed additional rent hereunder and shall be paid to Landlord on demand, and Landlord shall have (in addition to all other rights and remedies of Landlord) the same rights and remedies in the event of the nonpayment thereof by Tenant as in the case of default by Tenant in the payment of rent.
In the event of any action or proceeding brought by either party against the other under this Lease, the prevailing party shall be entitled to recover court costs and the reasonable fees of its attorneys in such action or proceeding (whether at the administrative, trial or appellate levels) in such amount as the court or administrative body may adjudge reasonable.
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If Tenant shall remain in possession after the expiration or sooner termination of this Lease with Landlords consent (which Landlord may withhold in its sole and absolute discretion), all of the terms, covenants and agreements hereof shall continue to apply and bind Tenant so long as Tenant shall remain in possession insofar as the same are applicable; provided, however, that if Tenant remains in possession without Landlords prior written consent, the Monthly Base Rent shall be one and one half (1.5) times the Monthly Base Rent payable for the last month of the Term for the first two (2) months of Tenants holdover, and thereafter two (2) times the sum of the Monthly Base Rent payable for the last month of the Term, prorated in either instance on a daily basis for each day that Tenant remains in possession. Tenant shall indemnify Landlord and Landlords Agent against any and all claims, losses and liabilities for damages resulting from failure to surrender possession, including, without limitation, any claims made by any succeeding tenant. If Tenant remains in possession with Landlords written consent, such tenancy shall be from month to month, terminable by either party on not less than thirty (30) days written notice.
The failure of Landlord to exercise its rights in connection with any breach or violation of any term, covenant or condition herein contained or in the Rules and Regulations shall not be deemed to be a waiver of such term, covenant or condition or any subsequent breach of the same or any other term, covenant or condition herein contained. The subsequent acceptance of rent hereunder by Landlord shall not be deemed to be a waiver of any preceding breach by Tenant of any term, covenant or condition of this Lease other than the failure of Tenant to pay the particular rent so accepted, regardless of Landlords knowledge of such preceding breach at the time of acceptance of such rent.
23.01 Taking of Premises. If all or any part of the Premises shall be taken by any public or quasi public authority as a result of the exercise of the power of eminent domain, this Lease shall terminate as to the part so taken as of the date of taking, and, in the case of a partial taking, either Landlord or Tenant shall have the right to terminate this Lease as to the balance of the Premises by written notice to the other within thirty (30) days after the date of such taking; provided, however, that a condition to the exercise by Tenant of such right to terminate shall be that the portion of the Premises taken shall, in Landlords judgment, be of such extent and nature as substantially to handicap, impede and impair Tenants use of the balance of the Premises. If a material part of the Building is condemned or taken or if substantial alteration or reconstruction of the Building shall, in Landlords opinion, be necessary or desirable as a result of such condemnation or taking, Landlord may terminate this Lease by written notice to Tenant within thirty (30) days after the date of taking.
23.02 Condemnation Award. In the event of any taking, Landlord shall be entitled to any and all compensation, damages, income, rent, awards, and any interest therein whatsoever which may be paid or made in connection therewith, and Tenant shall have no claim against Landlord for the value of any unexpired term of this Lease or otherwise. Nothing herein shall be construed to preclude Tenant from prosecuting any claim directly against the condemning authority for moving expenses, loss of business, for damage to, and cost of removal of, trade fixtures, furniture and other personal property belonging to Tenant, and for the unamortized cost of leasehold improvements to the extent same were installed at Tenants expense (and not with the proceeds of the Tenant Allowance, if any), provided, however, that no such claim shall diminish or adversely affect Landlords award. In no event shall Tenant have or assert a claim for the value of any unexpired term of this Lease. Subject to the foregoing provisions of this Section 23.02, Tenant hereby assigns to Landlord any and all of its right, title and interest in or to any compensation awarded or paid for the fee as a result of any such taking. In the event of a partial taking of the Premises which does not result in a termination of this Lease, the Monthly Base Rent thereafter to be paid shall be equitably reduced by Landlord. Each party waives the provisions of
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California Code of Civil Procedure Section 1265.130 allowing either party to petition the Superior Court to terminate this Lease in the event of a partial taking of the Premises.
23.03 Temporary Taking. If all of the Premises shall be condemned or taken for governmental occupancy for a period of more than six (6) months, this Lease shall terminate as of the date of taking and Landlord shall be entitled to any and all compensation, damages, income, rent and awards in connection therewith. If all or any part of the Premises shall be taken by any public or quasi-public authority on a temporary basis for a period of six (6) months or less, this Lease shall remain in full force and effect. Tenants rent hereunder shall be abated for the period of the temporary taking and Landlord shall be entitled to any and all compensation, damages, income, rent, awards and interest in connection therewith.
In the event of a sale or conveyance by Landlord of the Building and the assumption by the buyer of all Landlords obligations under this Lease, the same shall operate to release Landlord from any future liability upon any of the agreements, obligations, covenants or conditions, express or implied, herein contained in favor of Tenant, and in such event Tenant agrees to look solely to the responsibility of the successor in interest of Landlord in and to this Lease. In addition, Tenants right of recovery as to any pre-existing agreements, obligations, covenants or conditions, express or implied, herein contained in favor of Tenant shall be expressly limited to the net proceeds of sale actually received by Landlord. This Lease shall not be affected by any such sale, however, and Tenant agrees to attorn to the purchaser or assignee, such attornment to be effective and self-operative without the execution of any further instruments on the part of any of the parties to this Lease.
25.01 Subordination of this Lease. Unless Landlord or any lender holding a lien which affects the Premises elects otherwise, this Lease shall be subject and subordinated at all times to: (a) all ground or underlying leases which now or hereafter may affect the Building (a Superior Lease), and (b) the lien of all mortgages and deeds of trust (a Mortgage) in any amount or amounts whatsoever now or hereafter placed on or against the Building, on or against Landlords interest or estate therein, and on or against all such ground or underlying leases, all without the necessity of having further instruments executed on the part of Tenant to effectuate such subordination. Notwithstanding the foregoing: (i) in the event of termination for any reason whatsoever of any such Superior Lease, Tenant shall, if requested, attorn to the landlord of any such Superior Lease (the Superior Lessor), or, if requested, enter into a new lease for the balance of the original or extended Term then remaining, upon the same terms and provisions as are contained in this Lease; (ii) in the event of a foreclosure of any such Mortgage or of any other action or proceeding for the enforcement thereof, or of any sale thereunder, or the giving of any deed in lieu of such foreclosure, Tenant shall, if requested, attorn to the purchaser at such foreclosure sale or other action or proceeding, or to the grantee under any such deed given in lieu of foreclosure, or, if requested, enter into a new lease with such successor to Landlords interest for the balance of the original or extended Term then remaining upon the same terms and provisions as are in this Lease contained (it being understood, however, that no such successor to Landlords interest shall be bound by any payment of rent or any other charges under this Lease, other than security deposits, made more than one (1) month in advance, or by any amendment to or modification of this Lease made without such successors consent); and (iii) Tenant agrees to execute and deliver upon demand such further instruments evidencing such subordination of this Lease to such deed, to such Superior Leases, and to the lien of any such Mortgages as may reasonably be required by Landlord. Tenant shall from time to time on request from Landlord execute and deliver any documents or instruments that may be required by any lender to effectuate any subordination.
25.02 Subordination of Mortgage. Notwithstanding anything to the contrary set forth above, any mortgagee under any Mortgage may at any time subordinate its Mortgage to this Lease in whole or in part, without any need to obtain Tenants consent, by execution of a written document subordinating such Mortgage to this Lease to the
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extent set forth in such document and thereupon this Lease shall be deemed prior to such Mortgage to the extent set forth in such document without regard to their respective dates of execution, delivery and/or recording. In that event, to the extent set forth in such document, such Mortgage shall have the same rights with respect to this Lease as would have existed if this Lease had been executed, and a memorandum thereof, recorded prior to the execution, delivery and recording of the Mortgage.
25.03 Subordination and Non-Disturbance Agreement. Landlord shall use commercially reasonable efforts to request a non-disturbance agreement from Landlords first priority mortgage lender (on such lenders standard form) for the benefit of Tenant. Landlord shall not be in breach of this Lease or incur any obligation to Tenant if, for any reason whatsoever, such lender refuses to enter into a non-disturbance agreement. All costs and expenses (including, without limitation, Landlords and lenders legal fees and all costs of recordation) incurred in requesting, obtaining, negotiating and/or recording any non-disturbance agreement shall be borne by Tenant.
The voluntary or other surrender of this Lease by Tenant, or a mutual cancellation thereof, shall not work a merger, and shall, at the option of Landlord, terminate any or all existing subleases or subtenancies, or operate as an assignment to Landlord of any or all of such subleases or subtenancies.
ARTICLE 27SURRENDER OF PREMISES
At the end of the Term or upon sooner termination of this Lease, Tenant shall peaceably deliver up to Landlord possession of the Premises, together with all improvements or additions upon or belonging to the same, by whomsoever made, in the same condition as received, or first installed, reasonable wear and tear and damage by insured casualty excepted. Tenant may, upon the termination of this Lease, remove all movable partitions of less than full height from floor to ceiling, as well as counters and other trade fixtures installed by Tenant, repairing any damage caused by such removal. Property not so removed shall be deemed abandoned by Tenant and title to the same shall thereupon pass to Landlord. Upon request by Landlord unless otherwise agreed to in writing by Landlord, or as otherwise provided in Article 10 above, including without limitation, any cable, Tenant, at its cost, shall remove any or all permanent improvements or additions to the Premises installed by Tenant and all movable partitions, counters, and other trade fixtures which may be left by Tenant and repair any damage resulting from such removal. Tenants removal obligations with respect to the initial Tenant Improvements shall be governed by the Workletter.
ARTICLE 28ESTOPPEL CERTIFICATE
At any time and from time to time, but in no event on less than five (5) days prior written request by Landlord, Tenant shall execute, acknowledge and deliver to Landlord, promptly upon request, a certificate in the form of Exhibit E attached hereto (Estoppel Certificate), certifying: (a) that Tenant has accepted the Premises (or, if Tenant has not done so, that Tenant has not accepted the Premises, and specifying the reasons therefor); (b) the Commencement Date and Expiration Date of this Lease; (c) whether to the best knowledge of Tenant there are then existing any defaults by Landlord in the performance of its obligations under this Lease (and, if so, specifying the same); (d) that this Lease is unmodified and in full force and effect (or, if there have been modifications, that this Lease is in full force and effect, as modified, and stating the date and nature of each modification); (e) the capacity of the person executing such certificate, and that such person is duly authorized to execute the same on behalf of Tenant; (f) the date, if any, to which rent and other sums payable hereunder have been paid; (g) Tenant is not in default under the Lease nor does any event exist which, with the passage of time or the giving of notice or both would constitute an Event of Default; except as to defaults specified in the certificate; (h) the amount of any security deposit and prepaid rent; and (i) such other matters as may be reasonably requested by Landlord. Any such certificate may be relied upon by any prospective purchaser, mortgagee or beneficiary under any Mortgage affecting the Building or any part thereof. If Tenant fails to deliver
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the executed certificate within five (5) days after receipt thereof by Tenant, then Tenant shall be deemed to have accepted the Premises and it shall be an acknowledgment by Tenant that statements included in the estoppel certificate are true and correct, without exception.
ARTICLE 29NO LIGHT, AIR OR VIEW EASEMENT
Any diminution or shutting off of light, air or view by any structure which is now or may hereafter be erected on lands adjacent to the Building shall in no way affect this Lease or impose any liability on Landlord. Noise, dust or vibration or other incidents to new construction of improvements on lands adjacent to the Building, whether or not owned by Landlord, shall in no way affect this Lease or impose any liability on Landlord.
All notices and demands which may or are required to be given by either party to the other hereunder shall be in writing and shall be deemed to have been fully given when sent by nationally recognized overnight courier, facsimile machine (to the extent receipt of such facsimile is acknowledged by the addressee) or deposited in the United States mail, certified or registered, postage prepaid, and addressed as follows: prior to the date on which Tenant accepts possession of the Premises, at Tenants address prior to occupancy set out in Article l(q), and thereafter to Tenant at the address for Tenant set out in Article l(q), or to such other place as Tenant may from time to time designate in a notice to Landlord; to Landlord at the addresses specified in Article l(r), or to such other places as Landlord may from time to time designate in a notice to Tenant; or, in the case of Tenant, delivered to Tenant at the Premises. Tenant hereby appoints as its agent to receive the service of all dispossessory or distraint proceedings and notices thereunder the person in charge of or occupying the Premises at the time, and if no person shall be in charge of or occupying the same, then such service may be made by attaching the same to the main entrance of the Premises.
ARTICLE 31INTENTIONALLY DELETED
All the terms, covenants, and conditions hereof shall be binding upon and inure to the benefit of the heirs, executors, administrators, successors, and assigns of the parties hereto, provided that nothing in this Article 32 shall be deemed to permit any assignment, subletting, occupancy or use by Tenant contrary to the provision of Article 12.
33.01 Liability Insurance. Tenant shall obtain and keep in full force a policy of commercial general liability and property damage insurance (including automobile, personal injury, broad form contractual liability and broad form property damage) under which Tenant is named as the insured and Landlord, Landlords Agent and any lessors and mortgagees (whose names shall have been furnished to Tenant) are named as additional insureds and under which the insurer agrees to indemnify and hold the Landlord, Landlords Agent and all applicable lessors and mortgagees harmless from and against all cost, expense and/or liability arising out of or based upon the indemnification obligations of this Lease. The minimum limits of liability shall be a combined single limit with respect to each occurrence of not less than Four Million Dollars ($4,000,000), which can be satisfied with a combination of General Liability and Umbrella/Excess Liability limits. The policy shall contain a cross liability endorsement and shall be primary coverage for Tenant and Landlord for any liability arising out of Tenants and Tenants employees use, occupancy or maintenance of the Premises and all areas appurtenant thereto. Such insurance shall provide that it is primary insurance and not excess over or contributory with any other valid,
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existing and applicable insurance in force for or on behalf of Landlord. The policy shall not eliminate cross-liability and shall contain a severability of interest clause. Not more frequently than once each year, if, in the opinion of Landlords lender or of the insurance consultant retained by Landlord, the amount of public liability and property damage insurance coverage at that time is not adequate, Tenant shall increase the insurance coverage as required by either Landlords lender or Landlords insurance consultant.
33.02 Tenants Property Insurance. Tenant at its cost shall maintain on all of its personal property, Tenant Improvements (as defined in the Workletter) (whether constructed by Landlord or Tenant), and Alterations, in, on, or about the Premises, a policy of standard fire and extended coverage insurance, with theft, vandalism and malicious mischief endorsements, to the extent of at least full replacement value without any deduction for depreciation. The proceeds from any such policy shall be used by Tenant for the replacement of such personal property or the restoration of such tenant improvements or alterations. The full replacement value of the improvements to be insured under this Article 33 shall be determined by the company issuing the insurance policy at the time the policy is initially obtained. Not less frequently than once every three (3) years, Landlord shall have the right to notify Tenant that it elects to have the replacement value redetermined by an insurance company or insurance consultant. The redetermination shall be made promptly and in accordance with the rules and practices of the Board of Fire Underwriters, or a like board recognized and generally accepted by the insurance company, and each party shall be promptly notified of the results by the company. The insurance policy shall be adjusted according to the redetermination.
33.03 Workers Compensation Insurance. Tenant shall maintain Workers Compensation and Employers Liability insurance as required by law.
33.04 Business Interruption Insurance. Tenant shall maintain loss of income and business interruption insurance in such amounts as will reimburse Tenant for direct or indirect loss of earnings attributable to all perils commonly insured against by prudent tenants or attributable to prevention of access to the Premises or to the Building as a result of such perils but in no event in an amount less than the Base Monthly Rent and all additional rent payable hereunder for six (6) months.
33.05 Other Coverage. Tenant, at its cost, shall maintain such other insurance as Landlord may reasonably require from time to time, subject to thirty (30) days prior notice.
33.06 Insurance Criteria. All the insurance required under this Lease shall:
(a) Be issued by insurance companies authorized to do business in the State of California, with a financial rating of at least an A-VI status as rated in the most recent edition of Bests Insurance Reports.
(b) Be issued as a primary policy.
(c) Contain an endorsement requiring thirty (30) days written notice from the insurance company to both parties and to Landlords lender before cancellation or change in the coverage, scope, or amount of any policy.
(d) With respect to property loss or damage by fire or other casualty, a waiver of subrogation must be obtained, as required by Article 15.
33.07 Evidence of Coverage. A certificate of the policy, together with evidence of payment of premiums, shall be deposited with Landlord at the commencement of the term, and on renewal of the policy not less than twenty (20) days before expiration of the term of the policy.
33.08 Landlords Insurance. Landlord shall carry the types of insurance, and with such reasonable coverage limits as are normally and customarily carried by sophisticated landlords of Comparable Buildings, and the cost thereof shall be included in Direct Expenses.
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Landlord shall maintain in the lobby of the Building a directory containing the names of Tenant and other tenants of the Building. Tenant shall be entitled, at no additional cost, to initially list on such directory its name and that of its employees and permitted subtenants as Tenant desires, provided, the number of names so listed shall be in the same proportion to all names listed on such directory as the Rentable Area of the Premises bears to the Rentable Area of all tenants who are included in the directory. If Tenant requests Landlord to make any revisions or substitutions to the names initially included within the lobby directory, Landlord shall be entitled to charge Tenant, on a nondiscriminatory basis, its standard reprogramming fee.
ARTICLE 35TERMINATION OF MASTER LEASE AND MASTER SUBLEASE
(a) Tenant hereby acknowledges that the Building is subject to that certain Indenture of Lease dated as of January 22, 1973, executed by Pearlman Associates (Pearlman) and First Market Co. (First Market), jointly as the lessors, and Pearlman, as the lessee, as supplemented and amended (as so supplemented and executed, the Master Lease). Landlord is the successor in interest to Pearlman and First Market, as lessor, and to Pearlman, as lessee. In the event of the cancellation or termination of the Master Lease for any reason whatsoever or of the involuntary surrender of the Master Lease by operation of law prior to the Expiration Date, Tenant agrees to make full and complete attornment to Landlord under the Master Lease for the balance of the term of this Lease and upon the then executory terms hereof at the option of Landlord at any time during Tenants occupancy of the Premises, which attornment shall be evidenced by an agreement in form and substance reasonably satisfactory to Landlord. Tenant agrees to execute and deliver such an agreement at any time within ten (10) business days after request of Landlord, and Tenant waives the provisions of any law now or hereafter in effect which may give Tenant any right of election to terminate this Lease or to surrender possession of the Premises in the event any steps are taken, or any proceeding is brought, by Landlord under the Master Lease to terminate the Master Lease.
(b) Tenant hereby acknowledges that the Building is subject to that certain Indenture of Lease dated as of January 22, 1973, executed by Pearlman, as sublessor, and Steveland, Inc. (Steveland) and First Market, jointly as sublessees, as supplemented and amended (as so supplemented and amended, the Master Sublease). Landlord is the successor in interest to Pearlman, as sublessor, and to Steveland and First Market, as sublessee, under the Master Sublease. In the event of the cancellation or termination of the Master Sublease for any reason whatsoever or of the involuntary surrender of the Master Sublease by operation of law prior to the Expiration Date, Tenant agrees to make full and complete attornment to Landlord under the Master Sublease for the balance of the term of this Lease and upon the then executory terms hereof at the option of Landlord at any time during Tenants occupancy of the Premises, which attornment shall be evidenced by an agreement in form and substance reasonably satisfactory to Landlord. Tenant agrees to execute and deliver such an agreement at any time within ten (10) business days after request of Landlord, and Tenant waives the provisions of any law now or hereafter in effect which may give Tenant any right of election to terminate this Lease or to surrender possession of the Premises in the event any steps are taken, or any proceeding is brought, by Landlord under the Master Sublease to terminate the Master Sublease.
Tenant hereby acknowledges and agrees that the parking garage contained within the Building is managed, leased, maintained and operated by an independent parking garage operator (Operator) and not by Landlord or Landlords employees, agents or contractors. Any use of parking spaces in the parking garage by Tenant and/or Tenant Parties shall be pursuant to a separate agreement to be made and entered into directly by and between Tenant (and/or Tenant Parties) and Operator. All parking and delivery areas for all vehicles in respect to the Building shall be in accordance with parking regulations established from time to time by Landlord and/or Operator, with which regulations Tenant agrees to conform, and Tenant shall only permit parking by Tenant
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Parties in appropriate designated parking areas. Tenant hereby indemnifies and holds Landlord and Landlords Agent (as defined in Article l(b)) harmless against any and all loss, cost, damage, injury and expense arising out of or in any way related to claims for Tenants or Tenant Parties use of the parking garage.
37.01 Captions. The captions and headings of the Articles and Sections in this Lease are for convenience only and shall not in any way limit or be deemed to construe or interpret the terms and provisions hereof.
37.02 Time of Essence. Time is of the essence of this Lease and of all provisions hereof, except in respect to the delivery of possession of the Premises at the commencement of the Term hereof.
37.03 Terms: Joint and Several Liability. The words Landlord and Tenant, as used herein, shall include the plural as well as the singular. Words used in the masculine gender include the feminine and neuter. If there be more than one Landlord or Tenant or if Tenant is a partnership, the respective obligations hereunder imposed upon Landlord, Tenant and the general partners of Tenant, as the case may be, shall be joint and several.
37.04 Governing Law. This Lease shall be construed and enforced in accordance with the laws of the State of California.
37.05 Cumulative Remedies. It is understood and agreed that the remedies herein given to Landlord shall be cumulative, and the exercise of any one remedy by Landlord shall not be to the exclusion of any other remedy.
37.06 Entire Agreement. The terms of this Lease are intended by the parties as a final expression of their agreement with respect to such terms as are included in this Lease and may not be contradicted by evidence of any prior or contemporaneous agreement. The parties further intend that this Lease constitutes the complete and exclusive statement of its terms and that no extrinsic evidence whatsoever maybe introduced in any judicial proceedings, if any, involving this Lease.
37.07 Invalidity. If any provision of this Lease or the application thereof to any person or circumstance shall, to any extent, be invalid or unenforceable, the remainder of this Lease, or the application of such provision to persons or circumstances other than those as to which it is invalid or unenforceable, shall not be affected thereby, and each provision of this Lease shall be valid and be enforced to the full extent permitted by law.
37.08 Authority. If Tenant signs as a corporation or a partnership, each of the persons executing this Lease on behalf of Tenant does hereby covenant and warrant that Tenant is a duly authorized and existing entity, that Tenant has and is qualified to do business in California, that Tenant has full right and authority to enter into this Lease, and that each and both of the persons signing on behalf of Tenant are authorized to do so. Upon Landlords request, Tenant shall provide Landlord with evidence reasonably satisfactory to Landlord confirming the foregoing covenants and warranties.
37.09 Offer. The submission and negotiation of this Lease shall not be deemed an offer to enter into a lease by Landlord, but the solicitation of such an offer by Tenant. Tenant agrees that its execution of this Lease constitutes a firm offer to enter into the Lease which may not be withdrawn for a period of thirty (30) days after delivery to Landlord (or such other period as may be expressly provided in any other agreement signed by the parties). During such period and in reliance on the foregoing, Landlord may, at Landlords option (and shall, if required by applicable law), deposit any Deposit and rent, and proceed with any plans, specifications, alterations or improvements, and permit Tenant to enter the Premises, but such acts shall not be deemed an acceptance of Tenants offer to enter this Lease, and such acceptance shall be evidenced only by Landlord signing and delivering this Lease to Tenant.
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37.10 No Representations or Warranties. Neither Landlord nor Landlords agents or attorneys have made any representations or warranties with respect to the Premises, the Building or this Lease, except as expressly set forth herein, and no rights, easements or licenses are or shall be acquired by Tenant by implication or otherwise.
37.11 Brokers. Landlord and Tenant hereby warrant to each other that they have had no dealings with any real estate broker or agent in connection with the negotiation of this Lease, excepting only the real estate brokers or agents specified in Article 1(s) (the Brokers), and that they know of no other real estate broker or agent who is entitled to a commission in connection with this Lease. Each party agrees to indemnify and defend the other party against and hold the other party harmless from any and all claims, demands, losses, liabilities, lawsuits, judgments, and costs and expenses (including without limitation reasonable attorneys fees) with respect to any leasing commission or equivalent compensation alleged to be owing on account of the indemnifying partys dealings with any real estate broker or agent other than the Brokers.
37.12 Amendments. This Lease may not be altered, changed, or amended except by an instrument signed by both parties hereto.
37.13 Landlords Agent. Unless Landlord shall render written notice to Tenant to the contrary, Landlords Agent, as defined in Article l(b), is authorized to act as Landlords agent in connection with the performance of this Lease. Tenant shall deal solely with Landlords Agent in the administration and performance of this Lease. Tenant acknowledges that Landlords Agent is acting solely as agent for Landlord in connection with the foregoing; and Landlords Agent and its direct and indirect partners, officers, shareholders, directors and employees shall have no liability to Tenant in connection with the performance of this Lease and Tenant waives any and all claims against any such party arising out of, or in any way connected with, this Lease.
37.14 Proration. Any proration required hereunder shall, unless expressly provided otherwise herein, be done on the basis of a three hundred sixty (360) day year and/or a thirty (30) day month.
37.15 Waiver of Jury Trial. Landlord and Tenant by this Section 37.15 hereby waive trial by jury in any action, proceeding or counterclaim brought by either of the parties to this Lease against the other on any matters whatsoever arising out of or in any way connected with this Lease, the relationship of Landlord and Tenant, Tenants use or occupancy of the Premises, or any other claims (except claims for personal injury or property damage).
37.16 No Recordation. Neither Landlord nor Tenant shall record this Lease or any short form or memorandum thereof.
37.17 Exhibits. This Lease shall be deemed to mean this Lease and Exhibits A through I, which are attached to this Lease and incorporated in this Lease by this reference.
37.18 Patriot Act. Landlord and Tenant each hereby represents that it is not (i) in violation of any Anti-Terrorism Law (defined below), (ii) conducting any business or engaging in any transaction or dealing with any Prohibited Person (defined below), including the making or receiving of any contribution of funds, goods or services to or for the benefit of any Prohibited Person, (iii) dealing in, or otherwise engaging in any transaction relating to, any property or interests in property blocked pursuant to Executive Order No. 13224 (defined below), or (iv) engaging in or conspiring to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding, or attempts to violate any of the prohibitions set forth in, any Anti-Terrorism Law. Landlord and Tenant each hereby further represents that neither it nor any of its affiliates, officers, directors, shareholders, partners, members or lease guarantors is a Prohibited Person. As used herein, Anti-Terrorism Law means any law relating to terrorism, anti-terrorism, money-laundering or anti-money laundering activities, including the United States Bank Secrecy Act, the United States Money Laundering Control Act of 1986, Executive Order No. 13224, and Title 3 of the USA Patriot Act (defined below), and any regulations promulgated under any of them, each as may be amended from time to time. As used herein, Executive Order No. 13224 means
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Executive Order No. 13224 on Terrorist Financing effective September 24, 2001, and relating to Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism, as may be amended from time to time. As used herein, Prohibited Person means (i) a person or entity that is listed in, or owned or controlled by a person or entity that is listed in, the Annex to Executive Order No. 13224; (ii) a person or entity with whom Landlord or Tenant is prohibited from dealing or otherwise engaging in any transaction by any Anti-Terrorism Law; or (iii) a person or entity that is named as a specially designated national and blocked person on the most current list published by the U.S. Treasury Department Office of Foreign Assets Control at its official website, http://www.treasury.gov/ofac/downloads/tl1sdn.pdf, or at any replacement website or other official publication of such list. As used herein, USA Patriot Act means the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (Public Law 107-56).
37.19 Force Majeure. Any prevention, delay or stoppage due to strikes, lockouts, labor disputes, acts of God, inability to obtain services, labor, or materials or reasonable substitutes therefor, governmental actions, civil commotions, fire or other casualty, and other causes beyond the reasonable control of the party obligated to perform (collectively, the Force Majeure), notwithstanding anything to the contrary contained in this Lease (except with respect to the obligations imposed with regard to Rent and other charges to be paid by Tenant pursuant to this Lease, and except as to Tenants rights and obligations under Article 3(a) and Article 8 of this Lease), shall excuse the performance of such party for a period equal to any such prevention, delay or stoppage and, therefore, if this Lease specifies a time period for performance of an obligation of either party, that time period shall be extended by the period of any delay in such partys performance caused by a Force Majeure.
IN WITNESS WHEREOF, Landlord and Tenant have executed this Lease as of the Effective Date.
LANDLORD: | KNICKERBOCKER PROPERTIES, INC. XXXIII, | |||||||
a Delaware Corporation | ||||||||
By: | ||||||||
Steven M. Zaun | ||||||||
Its: Vice President | ||||||||
TENANT: | MEDIVATION, INC., | |||||||
a Delaware corporation | ||||||||
By: | ||||||||
Its: | VP Finance | |||||||
By: | ||||||||
Its: |
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EXHIBIT A
FLOOR PLAN
[Exhibit Commences on Following Page]
EXHIBIT A
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EXHIBIT B
OFFICE BUILDING RULES AND REGULATIONS
1. The sidewalks, halls, passages, courts, exits, vestibules, entrances, public areas, elevators, escalators and stairways of the Building shall not be obstructed by Tenant or used by it for any purpose other than ingress to and egress from the Premises (Landlord acknowledge there may be some temporary and non-material obstruction during Tenants move into the Premises, and Tenant shall use commercially reasonable efforts to minimize such obstructions). The halls, passages, exits, entrances, elevators, escalators and stairways are not for the general public, and Landlord shall, in all cases, retain the right to control and prevent access thereto by all persons whose presence in the judgment of Landlord would be prejudicial to the safety, character, reputation and interests of the Building and its tenants, provided that nothing herein contained shall be construed to prevent such access to persons with whom Tenant normally deals in the ordinary course of its business, unless such persons are engaged in illegal activities. Tenant shall not go upon the roof of the Building. If the Premises are situated on the ground floor with direct access to the street, then Tenant shall, at Tenants expense, keep the sidewalks and curbs directly in front of the Premises clean and free from dirt, refuse and other obstructions.
2. No sign, placard, picture, name, advertisement or notice visible from the exterior of the Premises shall be inscribed, painted, affixed or otherwise displayed by Tenant on any part of the Building without the prior written consent of Landlord. Landlord will adopt and furnish to Tenant general guidelines relating to signs inside the Building on the office floors. Tenant agrees to conform to such guidelines, but may request approval of Landlord for modifications, which approval will not be unreasonably withheld. All approved signs or lettering on doors shall be printed, painted, affixed or inscribed at the expense of Tenant by a person approved by Landlord, which approval will not be unreasonably withheld. Written material visible from outside the Building will not be permitted. Pursuant to Article 34, Landlord shall place Tenants name on the directory in the lobby of the Building. Tenant shall not have the right to have additional names placed on the directory without Landlords prior written consent, which consent will not be unreasonably withheld. Any such additional names shall be paid for in advance by Tenant.
3. The Premises shall not be used for the storage of merchandise held for sale to the general public or for lodging. No cooking shall be done or permitted by Tenant on the Premises, except the use by Tenant of underwriters laboratory approved microwave and equipment for brewing coffee, tea, hot chocolate and similar beverages shall be permitted, provided that such use is in accordance with all applicable federal, state and city laws, codes, ordinances, rules and regulations. Tenant shall not install, maintain or operate upon the Premises any vending machine, except for the use of its employees and guests, without the prior written consent of Landlord, which consent Landlord may not unreasonably withhold.
4. Tenant shall not employ any person or persons other than the janitor of Landlord for the purpose of cleaning the Premises, unless otherwise agreed to by Landlord in writing. Except with the written consent of Landlord, no person or persons other than those approved by Landlord shall be permitted to enter the Building for the purpose of cleaning the same. Tenant shall not cause any unnecessary labor by reason of Tenants carelessness or indifference in the preservation of good order and cleanliness.
5. Landlord will furnish Tenant with two (2) keys to each door lock in the Premises. Landlord may make a reasonable charge for these and any additional keys. Tenant shall not have any additional keys made. Tenant shall not alter any lock or install a new or additional lock or bolts on any door of its Premises without the prior written consent of Landlord. Tenant shall in each case furnish Landlord with a key for any such lock. Tenant, upon the termination of its tenancy, shall deliver to Landlord all keys to doors in the Building which shall have been furnished to Tenant.
6. The carrying in or out of freight, furniture or bulky material of any description must take place during such hours as Landlord may from time to time reasonably determine. The installation and moving of such freight,
EXHIBIT B
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furniture or bulky material shall be made upon twenty-four (24) hours prior written notice to the manager of the Building, use of the Building freight elevators shall be on a first come, first served basis, and the persons employed by the Tenant for such work must be reasonably acceptable to Landlord. Tenant may, subject to the provisions of the immediately preceding sentence, move freight, furniture, bulky matter and other material into or out of the Premises on weekdays after normal Building hours or on Saturdays between the hours of 8:00 a.m. and 6:00 p.m. provided Tenant pays the additional costs, if any, incurred by Landlord for elevator operators, lobby attendants and other expenses arising by reason of such move by Tenant (in an amount equal to Landlords standard charges for such services) and if, at least two (2) days prior to such move, Landlord requests Tenant to deposit with Landlord, as security for Tenants obligation to pay such additional costs, a sum which Landlord reasonably estimates to be the amount of such additional costs, then Tenant shall deposit such sum with Landlord as security for such costs. Landlord shall have the right to prescribe the weight, size and position of all equipment, materials, furniture or other property brought into the Building. Heavy objects, if considered necessary by Landlord, shall stand on wood strips of such thickness as is necessary to properly distribute the weight. Landlord will not be responsible for loss of or damage to any such property from any cause and all damage done to the Building by moving or maintaining such property shall be repaired at the expense of Tenant. Business machines and other equipment shall be placed and maintained by Tenant at Tenants expense in a setting sufficient, in Landlords reasonable judgment, to absorb and prevent unreasonable vibration and prevent noise and annoyance.
7. Tenant shall not use or keep in the Premises or the Building any kerosene, gasoline or flammable or combustible fluid or material other than limited quantities thereof reasonably necessary for the operation or maintenance of office equipment. Tenant shall not, without Landlords prior written approval, use any method of heating or air conditioning other than that supplied by Landlord. Tenant shall not use or keep or permit to be used or kept any hazardous or toxic materials or any foul or noxious gas or substance in the Premises or permit or suffer the Premises to be occupied or used in a manner offensive or objectionable to Landlord or other occupants of the Building by reason of noise, odors, vibrations, or interfere in any way with other tenants or those having business therein.
8. Landlord shall have the right, exercisable without notice and without liability to Tenant, to change the name and street address of the Building.
9. Landlord reserves the right to exclude from the Building, between the hours of 6:00 p.m. and 7:00 a.m. and at all hours on Saturdays, Sundays, and legal holidays all persons who do not present a pass to the Building signed by Landlord. Landlord will furnish passes to persons for whom Tenant requests the same in writing. Tenant shall be responsible for all persons for whom it requests passes and shall be liable to Landlord for all acts of such persons. Landlord shall, in no case, be liable for damages for any error with regard to the admission to or exclusion from the Building of any person. In the case of invasion, mob, riot, public excitement or other circumstances rendering such action advisable in Landlords opinion, Landlord reserves the right to prevent access to the Building during the continuance of the same by such action as Landlord may deem appropriate including closing doors.
10. No curtains, draperies, blinds, shutters, shades, screens or other coverings, hangings or decorations shall be attached to, hung or placed in, or used in connection with any window of the Building without the prior written consent of Landlord. No files, cabinets, boxes, containers or similar items shall be placed in, against or adjacent to any window of the Building so as to be visible from the outside of the Building. No bottles, parcels or other articles may be placed in the halls or in any other part of the Building, nor shall any article be thrown out of the doors or windows of the Premises.
11. Tenant shall not obtain for use in the Premises, ice, drinking water, food, beverage, towel or other similar services except at such reasonable hours and under such reasonable regulations as may be fixed by Landlord.
EXHIBIT B
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12. Tenant shall see that the doors of the Premises are closed and locked, that all water faucets, water apparatus and utilities are shut off before Tenant leaves the Premises, so as to prevent waste or damage, and for any default or carelessness in this regard, Tenant shall make good all injuries sustained by other tenants or occupants of the Building or Landlord. If the Premises, or any portion thereof, is on a multiple tenancy floor, Tenant shall keep the doors to the Building corridors closed at all times except for ingress and egress.
13. The lavatory rooms, toilets, urinals, wash bowls and other apparatus shall not be used for any purpose other than that for which they were constructed, no foreign substance of any kind whatsoever shall be thrown therein and the expense of any breakage, stoppage or damage resulting from the violation of this rule shall, if caused by Tenant, be borne by Tenant.
14. Except with the prior written consent of Landlord, Tenant shall not sell, or permit the sale of newspapers, magazines, periodicals, theater tickets, airlines tickets or any other goods or merchandise to the general public in or on the Premises nor shall Tenant carry on or permit or allow any employee or other person to carry on the business of stenography, typewriting or any similar business in or from the Premises for the service or accommodation of occupants of any other portion of the Building, nor shall the Premises be used for manufacturing of any kind, or any business or activity other than that specifically provided for in Tenants Lease.
15. Tenant shall not install any radio or television antenna, loudspeaker or other device on the roof or the exterior walls of the Building. No awnings, air conditioning units or other projections shall be attached to the outside walls or windowsills of the Building or otherwise project from the Building, without the prior written consent of Landlord.
16. Tenant shall not use in any space or public halls of the Building any hand trucks except those equipped with rubber tires and side guards or such other material handling equipment as Landlord may approve. No other vehicles of any kind shall be brought by Tenant into the Building or kept in or about the Premises.
17. Tenant shall store all its trash and garbage within the Premises. No material shall be placed in the trash boxes or receptacles if such material is of such nature that it may not be disposed of in the ordinary and customary manner of removing and disposing of trash and garbage in the city where the Building is located without being in violation of any law or ordinance governing such disposal. All garbage and refuse disposal shall be made only through entry ways and elevators provided for such purposes and at such times as Landlord shall designate.
18. Canvassing, peddling, soliciting and distribution of handbills or any other written materials in the Building are prohibited and Tenant shall cooperate to prevent the same.
19. Tenant shall not make or permit any noise in the Building that is annoying, unpleasant or distasteful, interfering in any way with other tenants or those having business with them, or bring into or keep within the Building or common areas any animal (except seeing eye dogs in the control of their master), bird or bicycle or other vehicle.
20. Tenant shall not mark, drive nails, screw or drill into the partitions, woodwork or plaster or in any way deface the Premises. All construction work in the Building shall comply with Landlords Agents standard operating procedures.
21. Landlord shall direct electricians as to where and how telephone and telegraph wires are to be introduced. No cutting or boring for wires shall be allowed without Landlords consent. The location of telephones, call boxes and office equipment affixed to the Premises shall be subject to Landlords approval.
22. Tenant shall not lay linoleum, tile, carpet or floor covering so that it is affixed to the floor of the Premises, without Landlords approval.
EXHIBIT B
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23. The requirements of Tenant will be attended to only upon application by telephone or in person at the office of the Building manager. Employees of Landlord shall not perform any work or do anything outside of their regular duties unless under special instructions from Landlord.
24. Landlord may waive any one or more of these rules and regulations for the benefit of any particular tenant or tenants, but no such waiver by Landlord shall be construed as a waiver of such Rules and Regulations in favor of any other tenant or tenants, nor prevent Landlord from thereafter enforcing any such Rules and Regulations against any or all of the tenants of the Building.
25. These Rules and Regulations are in addition to, and shall not be construed to in any way modify or amend, in whole or in part, the terms, covenants, agreements and conditions of the Lease.
26. Landlord reserves the right to make such other reasonable Rules and Regulations as, in its judgment, may from time to time be needed for the safety, care and cleanliness of the Building, and for the preservation of the order therein. In the event of any conflict between the Rules and Regulations and the terms of the Lease, the latter shall prevail.
27. Landlord shall not be responsible to Tenant or to any other person for the non-observance or violation of these Rules and Regulations by any other tenant or other person. Tenant shall be deemed to have read these Rules and Regulations and to have agreed to abide by them as a condition to its occupancy of the Premises.
28. The Ordinary Business Hours of the Building shall be 8:00 a.m. to 6:00 p.m. on business days (exclusive of Saturdays, Sundays and holidays).
29. Tenant shall not waste electricity, water or air-conditioning and agrees to cooperate fully with Landlord to assure the most effective operation of the Buildings heating and air-conditioning and to comply with any governmental energy-saving rules, laws or regulations of which Tenant has actual notice, and shall refrain from attempting to adjust controls, including room thermostats, installed for Tenants use. Tenant shall keep corridor doors closed, and shall close window coverings at the end of each business day.
30. Tenant shall not, without the prior written consent of Landlord, alter or repair the ceiling, remove any ceiling tiles, or remove or replace any lamps, light bulbs, or ceiling fixtures on the Premises. Landlord shall replace, and Tenant shall pay for the replacement of, any broken ceiling tiles, lamps, light bulbs or ceiling fixtures which Tenant damages.
31. Tenant assumes any and all responsibility for protecting the Premises from theft, robbery and pilferage, which includes keeping doors locked and other means of entry to the Premises closed.
32. Any consent, approval, request, agreement or other communication to be given or made under these Rules and Regulations shall be in writing.
33. Neither Tenant, its agents, employees or contractors shall have access to or make any changes, alterations, additions, improvements, repairs or replacements (collectively Telecommunications Related Work) to the telephone closets, telephone lines or any other communications facilities or equipment within the Building without the prior written approval of Landlord, which approval may be withheld in Landlords sole discretion. All contractors designated by Tenant to perform Telecommunications Related Work shall be licensed and shall be subject to Landlords prior written approval, which approval may be withheld by Landlord in its sole discretion. Contractors performing Telecommunications Related Work shall be required to provide evidence of insurance coverage satisfactory to Landlord, including, without limitation, naming Landlord as an additional insured on all liability policies. Any costs, expenses, and liabilities incurred by Landlord as a result of Tenant or Tenants contractor performing Telecommunications Related Work shall be subject to Tenants indemnification obligations under the Lease.
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34. For purposes of these Rules and Regulations the term Tenant shall include Tenants agents, servants, employees, contractors, visitors and invitees, and Tenant shall be responsible for the observance by all such persons of all of the foregoing Rules and Regulations and any additional Rules and Regulations promulgated by Landlord during the Term of the Lease.
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EXHIBIT C
WORKLETTER AGREEMENT
This Workletter Agreement (the Workletter) is executed simultaneously with and is an exhibit to that certain Lease (the Lease), dated as of the date hereof between KNICKERBOCKER PROPERTIES, INC. XXXIII, a Delaware corporation (Landlord), and MEDIVATION, INC., a Delaware corporation (Tenant), wherein Tenant is leasing certain office space (the Premises) at 525 Market Street, in San Francisco, California (the Building), as more particularly described in the Lease. In consideration of the parties entering into the Lease and of the mutual promises and covenants hereinafter contained, Landlord and Tenant hereby agree as follows:
1. Proposed and Final Plans.
(a) Tenant shall cause to be prepared and delivered to Landlord, for Landlords approval, the following proposed preliminary space plan (Proposed Plans) for all improvements Tenant desires to complete or have completed in the Premises (the Tenant Improvements):
(i) Architectural drawings (consisting of floor construction plan, ceiling lighting and layout, power, and telephone plan).
(ii) Mechanical drawings (consisting of HVAC, electrical (including any UPS equipment), telephone, and plumbing). Tenant acknowledges that part of the Tenant Improvements shall include (but shall not be limited to) the replacement of the existing Tuttle & Bailey terminal air boxes located in the Premises with Building-standard Titus VAV boxes, and that all such Titus VAV boxes shall comply with the Buildings Replacement VAV Box Design Criteria (August 26, 2011).
(iii) Finish schedule (consisting of wall finishes and floor finishes and miscellaneous details, including all window treatments which shall be Building-standard Mecho shades throughout the Premises).
(b) All architectural drawings shall be prepared at Tenants sole cost and expense (subject to Section 3, below) by a licensed architect designated by Tenant and approved by Landlord, whom Tenant shall employ. Tenant shall deliver one set of reproducible architectural drawings to Landlord. All mechanical drawings shall be prepared at Tenants sole cost and expense by a licensed engineer designated by Landlord, whom Tenant shall employ. Tenant shall reimburse Landlord for all reasonable out-of-pocket costs incurred by Landlord in reviewing the Proposed Plans and Final Plans. All costs and charges by Landlords consultants shall be deducted from the Tenant Improvements Allowance (or charged to Tenant) without mark-up on an open book basis (which shall not exceed Twenty Thousand Dollars ($20,000,000)).
(c) Within ten (10) business days after Landlords receipt of the architectural drawings, Landlord shall advise Tenant of any changes or additional information required to obtain Landlords approval.
(d) Within ten (10) business days after receipt of mechanical drawings, Landlord shall advise Tenant of any changes reasonably required to obtain Landlords approval.
(e) If Landlord disapproves of or requests additional information regarding the Proposed Plans, Tenant shall, within fifteen (15) days thereafter, revise the Proposed Plans disapproved by Landlord and resubmit such plans to Landlord or otherwise provide such additional information to Landlord. Landlord shall, within ten (10) business days after receipt of Tenants revised plans, advise Tenant of any additional changes which may be required to obtain Landlords approval. If Landlord reasonably disapproves the revised plans specifying the reason therefor, or requests further additional information, Tenant shall, within ten (10) days of receipt of Landlords required changes, revise such plans and resubmit them to Landlord or deliver to Landlord such further information as Landlord has requested. Landlord shall, again within ten (10) business days after receipt of Tenants revised plans, advise Tenant of further changes, if any, reasonably required for Landlords approval. This process shall continue until Landlord has approved Tenants revised Proposed
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Plans. After the Preliminary Plan is finally approved by Landlord, Tenant shall submit to Landlord construction drawings prepared by Tenants architect (Final Plans) which shall contain all plans to be bid and built from and shall include all fully engineered mechanical, electrical, HVAC, plumbing, and fire life/safety drawings, all based upon the Preliminary Plans, and shall be compatible with the design, construction and equipment of the Building, comply with all Laws, be capable of logical measurement and construction, contain all such information as may be required for the construction of the Tenant Improvements.
Landlord shall approve the Final Plans, or such portion as has from time to time been submitted, within fifteen (15) business days after receipt of same or designate by notice given within such time period to Tenant the specific changes reasonably required to be made to the Working Drawings in order to correct any design problem and shall return the Working Drawings to Tenant. Tenant shall make the minimum changes necessary in order to correct any such Design Problem and shall return the Working Drawings to Landlord, which Landlord shall approve or disapprove within fifteen (15) business days after Landlord receives the revised Working Drawings. This procedure shall be repeated until all of the Working Drawings are finally approved by Landlord and written approval has been delivered to and received by Tenant. Landlord agrees not to withhold its approval unreasonably. Tenant shall have no obligation to remove any portion of the Tenant Improvements at the end of the Term unless Landlord notifies Tenant, in a writing concurrently incorporated into Landlords approval of the Final Plans, that such removal will be required.
(f) All Proposed Plans and Final Plans shall comply with all applicable statutes, ordinances, regulations, laws, and codes and with the requirements of Landlords fire insurance underwriters. Neither review nor approval by Landlord of the Proposed Plans and resulting Final Plans shall constitute a representation or warranty by Landlord that such plans either (i) are complete or suitable for their intended purpose, or (ii) comply with applicable laws, ordinances, codes, regulations, or any insurance requirements, it being expressly agreed by Tenant that Landlord assumes no responsibility or liability whatsoever to Tenant or to any other person or entity for such completeness, suitability or compliance. Tenant shall not make any changes in the Final Plans without Landlords prior written approval, which shall not be unreasonably withheld or delayed; provided that Landlord may, in the exercise of its sole and absolute discretion, disapprove any proposed changes adversely affecting the Buildings structure, any asbestos-containing materials, systems, equipment or the appearance or value of the Building.
(g) [Intentionally Deleted]
(h) Within thirty (30) days after written request from Tenant, Landlord shall reimburse Tenant in an amount equal to $8,575.80, for Tenants architect to complete a preliminary space plan for the Premises, provided that Landlord has been provided with a CAD version of Tenants test fit plans.
(i) Landlord has no objection to Tenants installing card key readers in one (1) of the internal stairwells connecting the floors of the Premises as designated by Landlord. Tenant is responsible for obtaining all approvals therefore (including approvals of the San Francisco Fire Department). Tenant may only so use such stairwells for Tenants employees walking between floors and only if the original Tenant is occupying the entire Premises, and such use shall be subject to Landlords rules and regulations established from time to time with respect to such use.
(j) The term Landlord Delay as used in the Lease shall mean: (1) delay in the giving of authorizations or approvals by Landlord beyond the periods set forth in the Lease or the Workletter; (2) delay attributable to the interference of Landlord, its agents or contractors with the completion of Tenant Improvements; and (3) delay by Landlord in administering and paying when due the Tenant Allowance. In no event shall Tenants remedies or entitlements for the occurrence of a Landlord Delay be abated, deferred, diminished or rendered inoperative because of a prior, concurrent, or subsequent delay resulting from any action or inaction of Tenant. No Landlord Delay shall be deemed to have occurred unless and until Tenant has given written notice to Landlord specifying the action or inaction which Tenant contends constitutes a Landlord Delay. If such action or inaction is not cured within one (1) business day after Landlords receipt
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of such notice, then a Landlord Delay, as set forth in such notice, shall be deemed to have occurred commencing as of the date Landlord received such notice and continuing for the number of days the substantial completion of the Premises was in fact delayed as a direct result of such action or inaction.
2. Performance of the Tenant Improvements.
(a) Filing of Final Plans, Permits. Tenant, at its sole cost and expense, shall file the Final Plans with the governmental agencies having jurisdiction over the Tenant Improvements. Tenant shall furnish Landlord with copies of all documents submitted to all such governmental agencies and with the authorizations to commence work and the permits for the Tenant Improvements issued by such governmental agencies. Tenant shall not commence the Tenant Improvements until the required governmental authorizations for such work are obtained and delivered to Landlord.
(b) Landlord Approval of Contractors. No later than five (5) days following Landlords approval of the Final Plans, Tenant shall enter into a contract for construction of the Tenant Improvements with a general contractor acceptable to Landlord (the General Contractor). Landlord hereby approves of Skyline Construction as General Contractor, if selected by Tenant. The General Contractor and Tenants construction contract with the General Contractor shall be subject to Landlords prior approval, which approval shall not be unreasonably withheld, conditioned or delayed. The General Contractor shall be responsible for all required construction, management and supervision, including bidding by subcontractors for the various components of the work of the Tenant Improvements. In addition, Tenant shall only utilize for purposes of mechanical, electrical, structural, sprinkler, fire and life safety and asbestos related activities those contractors as specifically designated by Landlord (collectively, the Essential Subs). Tenant shall submit to Landlord not less than ten (10) days prior to commencement of construction the following information and items:
(i) The names and addresses of the other subcontractors, and sub-subcontractors (collectively, together with the General Contractor and Essential Subs, the Tenants Contractors) Tenant intends to employ in the construction of the Tenant Improvements. Landlord shall have the right to approve or disapprove Tenants Contractors, and Tenant shall employ, as Tenants Contractors, only those persons or entities approved by Landlord, which approval shall not be unreasonably withheld, conditioned or delayed (and failure to respond within ten (10) business days following delivery of a request for approval shall be deemed disapproval). All contractors and subcontractors engaged by or on behalf of Tenant for the Premises shall be licensed contractors, possessing good labor relations, capable of performing quality workmanship and working in harmony with Landlords contractors and subcontractors and with other contractors and subcontractors on the job site. All work shall be coordinated with any general construction work in the Building. Tenant agrees to give the contractor employed by Landlord in the Building an equal opportunity to submit a bid for the Tenant Improvements, but Tenant shall not be obligated to hire such contractor.
(ii) The scheduled commencement date of construction, the estimated date of completion of construction work, fixturing work, and estimated date of occupancy of the Premises by Tenant.
(iii) Itemized statement of estimated construction cost, including permits and fees, architectural, engineering, and contracting fees.
(iv) Certified copies of insurance policies or certificates of insurance as hereinafter described. Tenant shall not permit Tenants Contractors to commence work until the required insurance has been obtained and certified copies of policies or certificates have been delivered to Landlord.
(c) Access to Premises. Tenant, its employees, designers, contractors and workmen shall have access to and primary use of the Premises prior to the commencement of the Term of the Lease to construct the Tenant Improvements, provided that Tenant and its employees, agents, contractors, and suppliers only access the Premises via the Building freight elevator work in harmony and do not interfere with the performance of other work in the Building by Landlord, Landlords contractors, other tenants or occupants of the Building (whether or not the terms of their respective leases have commenced) or their contractors. If
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at any time such entry shall cause, or in Landlords reasonable judgment threaten to cause, such disharmony or interference, Landlord may terminate such permission upon twenty-four (24) hours written notice to Tenant, and thereupon, Tenant or its employees, agents, contractors, and suppliers causing such disharmony or interference shall immediately withdraw from the Premises and the Building until Landlord determines such disturbance no longer exists.
(d) Landlords Right to Perform. Landlord shall have the right, but not the obligation, to perform, on behalf of and for the account of Tenant, subject to reimbursement by Tenant, any of the Tenant Improvements which (i) Landlord reasonably deems necessary to be done on an emergency basis, (ii) pertains to structural components or the general Building systems, (iii) pertains to the erection of temporary safety barricades or signs during construction, (iv) affects any asbestos-containing materials. Except in case of emergency, Landlord shall give prior reasonable written notice to Tenant of its intention to perform such work.
(e) Warranties. On completion of the Tenant Improvements, Tenant shall provide Landlord with copies of all warranties of at least one (1) year duration on all the Tenant Improvements. At Landlords request, Tenant shall enforce, at Tenants expense, all guarantees and warranties made and/or furnished to Tenant with respect to the Tenant Improvements.
(f) Protection of Building. All work performed by Tenant shall be performed with a minimum of interference with other tenants and occupants of the Building and shall conform to the Building Rules and Regulations attached to the Lease as Exhibit B, and those rules and regulations governing construction in the Building as Landlord or Landlords Agent may impose. Tenant will take all reasonable and customary precautionary steps to protect its facilities and the facilities of others affected by the Tenant Improvements and to properly police same and Landlord shall have no responsibility for any loss by theft or otherwise. Construction equipment and materials are to be located in confined areas and delivery and loading of equipment and materials shall be done at such reasonable locations and at such time as Landlord shall direct so as not to burden the operation of the Building. Landlord shall advise Tenant in advance of any special delivery and loading dock requirements. Tenant shall at all times keep the Premises and adjacent areas free from accumulations of waste materials or rubbish caused by its suppliers, contractors or workmen. Landlord may require daily clean-up if required for fire prevention and life safety reasons or applicable laws and reserves the right to do clean-up at the expense of Tenant if Tenant fails to comply with Landlords cleanup requirements. At the completion of the Tenant Improvements, Tenants Contractors shall forthwith remove all rubbish and all tools, equipment and surplus materials from and about the Premises and Building. Any damage caused by Tenants Contractors to any portion of the Building or to any property of Landlord or other tenants shall be repaired forthwith after written notice from Landlord to its condition prior to such damage by Tenant at Tenants expense.
(g) Compliance by all Tenant Contractors. Tenant shall impose and enforce all terms hereof on Tenants Contractors and its designers, architects and engineers. Landlord shall have the right to order Tenant or any of Tenants Contractors, designers, architects or engineers who willfully violate the provisions of this Workletter to cease work and remove himself or itself and his or its equipment and employees from the Building.
(h) Accidents. Notice to Landlord. Tenants Contractors shall assume responsibility for the prevention of accidents to its agents and employees and shall take all reasonable safety precautions with respect to the work to be performed and shall comply with all reasonable safety measures initiated by the Landlord and with all applicable laws, ordinances, rules, regulations and orders of any public authority for the safety of persons or property. Tenant shall advise the Tenants Contractors to report to Landlord any injury to any of its agents or employees and shall furnish Landlord a copy of the accident report filed with its insurance carrier within three (3) days of its occurrence.
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(i) Required Insurance. Tenant shall cause Tenants Contractors to secure, pay for, and maintain during the performance of the construction of the Tenant Improvements, insurance in the following minimum coverages and limits of liability:
(i) Workmens Compensation and Employers Liability Insurance as required by law.
(ii) Commercial General Liability Insurance (including Owners and Contractors Protective Liability) in an amount not less than Two Million Dollars ($2,000,000) per occurrence, whether involving bodily injury liability (or death resulting therefrom) or property damage liability or a combination thereof with a minimum aggregate limit of Two Million Dollars ($2,000,000), and with umbrella coverage with limits not less than Ten Million Dollars ($10,000,000). Such insurance shall provide for explosion and collapse, completed operations coverage with a two-year extension after completion of the work, and broad form blanket contractual liability coverage and shall insure Tenants Contractors against any and all claims for bodily injury, including death resulting therefrom and damage to the property of others and arising from its operations under the contracts whether such operations are performed by Tenants Contractors, or by anyone directly or indirectly employed by any of them.
(iii) Comprehensive Automobile Liability Insurance, including the ownership, maintenance, and operation of any automotive equipment, owned, hired, or non-owned in an amount not less than Five Hundred Thousand Dollars ($500,000) for each person in one accident, and One Million Dollars ($1,000,000) for injuries sustained by two or more persons in any one accident and property damage liability in an amount not less than One Million Dollars ($1,000,000) for each accident. Such insurance shall insure Tenants Contractors against any and all claims for bodily injury, including death resulting therefrom, and damage to the property of others arising from its operations under the contracts, whether such operations are performed by Tenants Contractors, or by anyone directly or indirectly employed by any of them.
(iv) All-risk builders risk insurance upon the entire Tenant Improvements to the full insurance value thereof. Such insurance shall include the interest of Landlord and Tenant (and their respective contractors and subcontractors of any tier to the extent of any insurable interest therein) in the Tenant Improvements and shall insure against the perils of fire and extended coverage and shall include all-risk builders risk insurance for physical loss or damage including, without duplication of coverage, theft, vandalism, and malicious mischief. If portions of the Tenant Improvements are stored off the site of the Building or in transit to such site are not covered under such all-risk builders risk insurance, then Tenant shall effect and maintain similar property insurance on such portions of the Tenant Improvements. Any loss insured under such all-risk builders risk insurance is to be adjusted with Landlord and Tenant and made payable to Landlord as trustee for the insureds, as their interest may appear, subject to the agreement reached by such parties in interest, or in the absence of any such agreement, then in accordance with a final, nonappealable order of a court of competent jurisdiction. If after such loss no other special agreement is made, the decision to replace or not replace any such damaged Tenant Improvements shall be made in accordance with the terms and provisions of the Lease including, without limitation, this Workletter. The waiver of subrogation provisions contained in Article 15 of the Lease shall apply to the all-risk builders risk insurance policy to be obtained by Tenant pursuant to this paragraph.
All policies (except the workmens compensation policy) shall be endorsed to include as additional named insureds Landlord and its officers, employees, and agents, Landlords contractors, Landlords architect, and such additional persons as Landlord may designate. Such endorsements shall also provide that all additional insured parties shall be given thirty (30) days prior written notice of any reduction, cancellation, or nonrenewal of coverage by certified mail, return receipt requested (except that ten (10) days notice shall be sufficient in the case of cancellation for nonpayment of premium) and shall provide that the insurance coverage afforded to the additional insured parties thereunder shall be primary to any insurance carried independently by such additional
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insured parties. Landlord shall furnish a list of names and addresses of parties to be named as additional insureds. The insurance policies required hereunder shall be considered as the primary insurance and shall not call into contribution any insurance then maintained by Landlord. Additionally, where applicable, such policy shall contain a cross-liability and severability or interest clause.
To the fullest extent permitted by law, Tenant (and Tenants Contractors) and Landlord (and its contractors) shall indemnify and hold harmless the other party, its officers, agents and employees, from and against all claims, damages, liabilities, losses and expenses of whatever nature, including but not limited to reasonable attorneys fees, the cost of any repairs to the Premises or Building necessitated by activities of the indemnifying partys contractors, bodily injury to persons or damage to property of the indemnified party, its employees, agents, invitees, licensees, or others, arising out of or resulting from the performance of work by the indemnifying party or its contractors. The foregoing indemnity shall be in addition to the insurance requirements set forth above and shall not be in discharge or substitution of the same, and shall not be limited in any way by any limitations on the amount or type of damages, compensation or benefits payable by or for Tenants Contractors under Workers or Workmens Compensation Acts, Disability Benefit Acts or other Employee Benefit Acts.
(j) Quality of Work. The Tenant Improvements shall be constructed in a first-class workmanlike manner using only good grades of material and in compliance with the Final Plans, all insurance requirements, applicable laws and ordinances and rules and regulations of governmental departments or agencies and the rules and regulations adopted by Landlord for the Building.
(k) As-Built Plans. Upon completion of the Tenant Improvements, Tenant shall furnish Landlord with as built plans for the Premises, final waivers of lien for the Tenant Improvements, a detailed breakdown of the costs of the Tenant Improvements (which may be in the form of an owners affidavit) and evidence of payment reasonably satisfactory to Landlord, and an occupancy permit for the Premises.
(l) Mechanics Liens. Tenant shall not permit any of the Tenants Contractors to place any lien upon the Building, and if any such lien is placed upon the Building, Tenant shall within ten (10) days of notice thereof, cause such lien to be discharged of record, by bonding or otherwise. If Tenant shall fail to cause any such lien to be discharged, Landlord shall have the right to have such lien discharged and Landlords expense in so doing, including bond premiums, reasonable legal fees and filing fees, shall be immediately due and payable by Tenant.
3. Payment of Costs of the Tenant Improvements.
(a) Subject to the provisions of Paragraph 3(b) below, the Tenant Improvements (including the cost of acquiring and installing the Building Standard window blinds to the extent not in place) shall be installed by Tenant at Tenants sole cost and expense. The cost of the Tenant Improvements shall include, and Tenant agrees to pay Landlord for, the following costs (Landlords Costs): (i) the cost of all work performed by Landlord on behalf of Tenant and for all materials and labor furnished on Tenants behalf, (ii) all permit, design and engineering fees, all HVAC and sprinkler reconfiguration costs, and all life safety costs, (iii) the cost of any services provided to Tenant or Tenants Contractors including but not limited to the cost for rubbish removal, hoisting, and utilities to the extent not included in general conditions charges by the general contractor, and (iv) the Supervision Fee plus Landlords actual out-of-pocket expenses for review of Tenants Proposed Plans and Final Plans. Landlord may render bills to Tenant monthly for Landlords Costs (provided that the supervision fee shall be billed based on the cost of the Tenant Improvements performed during the period in question). All bills shall be due and payable no later than the thirtieth (30th) day after delivery of such bills to Tenant. The Tenant Allowance may not be applied against any costs associated with data cabling, telecommunication equipment installation, Tenants signage, or rent. The Supervision Fee shall be an amount equal to three percent (3%) of the total cost of installation and construction of the Tenant Improvements.
(b) Landlord shall provide Tenant with an allowance of up to Two Million Five Hundred Seventy-Two Thousand Seven Hundred Forty and No/100 Dollars ($2,572,740.00) (Tenant Allowance) to be used
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toward payment of the costs incurred by Tenant for hard construction costs, permits, design and engineering fees, upgrades to the shell and core, Building mechanical, plumbing, HVAC, electrical, structural, and fire life safety systems, and Landlords Costs in connection with the Tenant Improvements. The Tenant Allowance may not be used for non-Building standard signage or data/telecommunications cabling or installation. If Landlord reasonably anticipates that the Tenant Improvement costs may exceed the Tenant Allowance (such excess shall be referred to herein as the Over Allowance Amount), and there is an Over-Allowance Amount required to be paid by Tenant pursuant to this Section for such disbursement, Landlord shall only be required to make a disbursement equal to Landlords pro rata share thereof and simultaneously with each disbursement, Tenant will pay its pro rata share thereof. For purposes hereof, Landlords pro rata share for each such disbursement amount shall equal the percentage resulting from dividing the Tenant Allowance by the total cost of the Tenant Improvement costs (as may be revised from time to time), and Tenants pro rata share for each such disbursement amount shall equal the Over-Allowance Amount divided by such total cost of the Tenant Improvement costs. Landlords payment of such amounts shall not be deemed Landlords approval or acceptance of the work furnished or materials supplied as set forth in Tenants draw request. If Landlord reasonably estimates that there will be an Over Allowance Amount payable by Tenant, then Tenant shall pay Tenants pro rata share (as described above) of the Over-Allowance Amount directly to the Contractor during the construction of the Tenant Improvements as a condition precedent to Landlords obligation to disburse Landlords pro rata share of the Tenant Allowance. The Tenant Improvements must be completed, and Tenant must have submitted its request for reimbursement in accordance with the terms of this Paragraph 3, no later than December 31, 2012. If the cost of all items of the Tenant Improvements is less than the Tenant Allowance or if Tenant has not submitted its request for reimbursement for the entire Tenant Allowance in accordance with this Workletter by the foregoing deadline, Tenant shall not be entitled to any payment or credit for such excess or unused amount. Funds may be drawn against the Tenant Allowance at any time and from time to time prior to December 31, 2012, subject to the following:
(i) Tenant may not make more than one draw in any calendar month;
(ii) With each draw request, Tenant shall submit to Landlord the following documents:
(A) A true and correct copy of the application for payment by Tenants Contractors for the Tenant Improvements completed to date, including sworn statements evidencing the cost of the Tenant Improvements performed to date (or in the case of subcontractors and materialmen, sworn statements for the last preceding draw request) together with copies on all receipted bills and invoices;
(B) Conditional or final lien waivers with respect to the Tenant Improvements performed to date from Tenants Contractors and any materialmen (or in the case of subcontractors and materialmen and except for the final disbursement of the Tenant Allowance, unconditional lien waivers for the last preceding draw request);
(C) Tenants certification to Landlord that the amounts set forth in all contractors sworn statements are owed to Tenants Contractors for the Tenant Improvements performed to date;
(D) The total cost of the Tenant Improvements based on the Final Plans, as such cost may change from time to time;
(E) With the final draw request, Tenant shall submit to Landlord a certificate from Tenants Architect stating that the Tenant Improvements has been completed in accordance with the Final Plans and applicable zoning, building, environmental and other laws and Unconditional Waiver and Release Upon Progress Payment from the General Contractor and each of Tenants Contractors who have not theretofore delivered such unconditional waiver and release.
(iii) Landlord will disburse the portion of the Tenant Allowance allocable to each draw request to Tenant or at Tenants request or at Landlords option directly to Tenants Contractors within thirty
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(30) days after Tenant has submitted the required information for such draw and has otherwise complied with the requirements hereof.
(c) Tenant shall pay for the Tenant Improvements and shall not permit the Premises or Building or underlying property to become subject to any lien on account of labor, material, or services furnished to Tenant.
(d) In the event Landlord wrongfully fails to disburse any amount of the Tenant Allowance as required hereunder after Tenant has submitted all documents required hereunder with respect to such disbursement request and such failure continues for sixty (60) days after notice delivered to Landlord strictly in accordance with the Lease, Tenant shall have the right to (i) disburse such unpaid amounts to the General Contractor and (ii) offset such amounts against Base Rent next due and owing (up to an amount not to exceed 20% of the then scheduled Base Rent amount in any month).
4. Miscellaneous.
(a) Tenant agrees that, in connection with the Tenant Improvements and its use of the Premises prior to the commencement of the Term of the Lease, Tenant shall have those duties and obligations with respect thereto that it has pursuant to the Lease during the Term, except the obligation for payment of rent, and further agrees that Landlord shall not be liable in any way for injury, loss, or damage which may occur to any of the Tenant Improvements or installations made in the Premises, or to any personal property placed therein, the same being at Tenants sole risk, except to the extent caused by the gross negligence or willful misconduct of Landlord or Landlord Parties.
(b) Except as expressly set forth in the Lease, Landlord has no other agreement with Tenant and Landlord has no other obligation to do any other work or pay any amounts with respect to the Premises. Any other work in the Premises which may be permitted by Landlord pursuant to the terms and conditions of the Lease shall be done at Tenants sole cost and expense and in accordance with the terms and conditions of the Lease.
(c) This Workletter shall not be deemed applicable to any additional space added to the original Premises at any time or from time to time, whether by any options under the Lease or otherwise, or to any portion of the original Premises or any additions thereto in the event of a renewal or extension of the initial term of the Lease, whether by any options under the Lease or otherwise, unless expressly so provided in the Lease or any amendment or supplement thereto.
(d) The failure by Tenant to pay any monies due to Landlord pursuant to this Workletter within five (5) business days after notice from Landlord to Tenant shall be deemed an Event of Default under the terms of the Lease for which Landlord shall be entitled to exercise all remedies available to Landlord for nonpayment of Rent. All late payments shall bear interest pursuant to Section 18.04 of the Lease.
(e) Neither Landlords Agent nor the partners compromising Landlord or Landlords Agent, nor the shareholders (nor any of the partners comprising same), directors, officers, or shareholders of any of the foregoing (collectively, the Parties) shall be liable for the performance of Landlords obligations under this Workletter. Tenant shall look solely to Landlord to enforce Landlords obligations hereunder and shall not seek any damages against any of the Parties. The liability of Landlord for Landlords obligations under this Worklctter shall not exceed and shall be limited to Landlords interest in the Building and Tenant shall not look to the property or assets of any of the Parties in seeking either to enforce Landlords obligations under this Workletter or to satisfy a judgment for Landlords failure to perform such obligations. Upon a sale of the Building by Landlord, if the buyer has assumed Landlords duties, obligations and liabilities hereunder, Tenant shall look solely to the buyer to enforce Tenants rights under this Workletter arising after the date of such sale.
(f) Tenant shall be solely responsible to determine at the site all dimensions of the Premises and the Building which affect any work to be performed by Tenant hereunder.
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LANDLORD: | KNICKERBOCKER PROPERTIES, INC. XXXIII, a Delaware corporation | |||||||
By: | ||||||||
Steven M. Zaun | ||||||||
Its: Vice President |
TENANT: | MEDIVATION, INC., a Delaware corporation | |||||||
By: | ||||||||
Its: | VP Finance | |||||||
By: | ||||||||
Its: | ||||||||
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EXHIBIT D
DESIGN STANDARDS
1. HVAC
a. Outside summer: 79 degrees FDB
b. Inside summer: 74 degrees + or - 2.5 degrees FDB (shades drawn)
c. Outside winter: 38 degrees FDB
d. Inside winter: 72 degrees FDB + or - 2.5 degrees FDB (shades drawn)
e. Population Density: One occupant per 150 usable square feet. The greater of 15 cfm outside air per occupant or 0.15 cfm outside air per usable square foot in accordance with Title 24 of the California Code of Regulations
2. Electrical
a. Subject to Title 24 of the California Code of Regulations, 1.5 watts per usable square foot connected load/lighting/power 480/277 volts
b. Subject to Title 24 of the California Code of Regulations, 3.5 watts per usable square foot connected load/miscellaneous power 120/208 volts
Total of 5 watts per usable square foot connected load
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EXHIBIT E
ESTOPPEL CERTIFICATE
,20
Knickerbocker Properties, Inc. XXXIII
c/o J.P. Morgan Investment Management, Inc.
525 Fifth Avenue
New York, NY 10036
Attn: Asset Manager for 525 Market
Re: | Lease dated as of , 20 , between Knickerbocker Properties, Inc. XXXIII, a Delaware corporation, as landlord (the Landlord), and , as tenant (the Tenant), as amended by Agreement(s) dated , 20 (said lease, as so amended, the Lease) for the Floor at the building known as 525 Market Street, San Francisco, California (the Premises) |
Gentlemen:
The undersigned Tenant hereby certifies that:
1. Tenant has accepted possession of the Premises (or, if Tenant has not done so, that Tenant has not accepted possession of the Premises, and specify the reasons therefor);
2. The Term Commencement and Expiration Dates of the Lease are and , respectively;
3. (a) As of this date, the Annual Base Rent for the period including through , is $ , payable monthly, in advance, at $ per month, on the first day of each calendar month.
(b) The increase in the annual rental rate for Increased Direct Expenses, which was billed by Landlord, and is payable by Tenant, in the calendar year 20 is $ ; and the monthly payment thereof of $ has been paid for all months through , 20 . The increase in the annual rental rate for Increased Taxes, which was billed by Landlord, and is payable by Tenant in the calendar year
20 is $ ; and the monthly payment thereof of $ has been paid for all months through , 20 .
(c) There is no unexpired rental concession or abatement under the Lease.
4. There are no existing defaults by Landlord in the performance of its obligations under the Lease (or, if a default exists, specify the same) nor to the best of Tenants knowledge, is there now any fact or condition which, with notice or lapse of time or both will become such default; and there is no offset, defense, counterclaim or credit against any rental or other payment due under the Lease, or with respect to any transaction between Landlord and Tenant;
5. The Lease is unmodified and in full force and effect and constitutes the entire agreement between Landlord and Tenant with respect to the Premises;
6. , as the of Tenant, is duly authorized to execute this certificate on behalf of Tenant;
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7. Tenant is not in default under the Lease nor does any event exist which, with the passage of time or the giving of notice or both, would constitute an Event of Default by Tenant and Tenant has not assigned, transferred or otherwise encumbered its interest under the Lease, nor subleased any of the Premises; except as follows: ;
8. Except as set forth and follows in the Lease , Tenant (a) does not have any right to renew or extend the Term of the Lease, (b) does not have any right to cancel or surrender the Lease prior to the expiration of the Term of the Lease, (c) does not have any option or preferential right to purchase all or any part of the Premises or purchase or lease all or any part of the property of which the Premises are a part, (d) does not have any right to relocate into other property owned by Landlord or owned by a person who is, to Tenants knowledge, an affiliate of Landlord, and (e) does not have any right, title or interest with respect to the Premises other than as Tenant under the Lease;
9. Tenant has not given or received written notice that Tenants insurance coverage, if any, under the Lease will be canceled or not renewed;
10. Landlord currently holds a security deposit under the Lease in the amount of $ ;
11. Tenant has not prepaid rent more than one (1) month in advance; and
12. This certificate shall inure to the benefit of , and its successors and assigns and to the benefit of any other lender which is beneficiary under a deed of trust encumbering the Premises or encumbering any property of which the Premises is a part and their successors and assigns; and this certificate shall be binding upon Tenant and its legal representatives, successors and assigns.
TENANT: | ||||||||
By: | ||||||||
Name: | ||||||||
Title: |
EXHIBIT E
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EXHIBIT F
CALIFORNIA ASBESTOS ANNUAL NOTICE
In 1988, California enacted legislation (specifically, Chapter 10.4 of the Health and Safety Code, Section 25915 et seq.) requiring landlords and tenants of commercial buildings constructed prior to 1979 to notify certain people, including each other and their respective employees working within such building, of any knowledge they may have regarding any asbestos containing materials or asbestos-containing construction materials (collectively, ACM) in the building.
On July 13, 1995, Title 29, Code of Federal Regulations, Section 1910.1001 and 1926.1101 defined Presumed Asbestos Containing Material (PACM) as thermal system insulation, and surfacing material, asphalt and vinyl flooring found in buildings constructed no later than 1980. The federal standard requires the building and/or facility owner to notify contractors and tenants of the presence of ACM/PACM. On May 3, 1996, Cal/OSHA adopted the same notification requirements for PACM in Title 8 CCR 5208 & 1529.
This notification is being given to provide the information required under this Legislation in order to help you avoid any unintentional contact with the ACM/PACM, to assure that appropriate precautionary measures are taken before disturbing any ACM/PACM, and to assist you in making appropriate disclosures to your employees and others.
We have engaged qualified asbestos consultants to survey the Building for asbestos and to assist in implementing an asbestos control program that includes, among other things, periodic reinspection and surveillance, air monitoring as necessary, information and training programs for building engineering and other measures to minimize potential fiber releases. A description of the current Operations and Maintenance Program prepared for the Building (the O&M Program) is set forth on Schedule A attached hereto. Our asbestos consultant has provided us with the O&M Program, which in its qualified professional opinion, fully complies with the disclosure requirements of Health and Safety Code Section 25915.1.
We have no reason to believe, based upon the O&M Program, that the ACM/PACM in the Building is currently in a condition to release asbestos fibers which would pose a significant health hazard to the Buildings occupants. This should remain so if such ACM/PACM is properly handled and remains undisturbed. You should take into consideration that our knowledge as to the absence of health risks is based solely upon general information and the information contained in the O&M Program, and that we have no special knowledge concerning potential health risks resulting from exposure to asbestos in the Building. We are therefore required by the above-mentioned legislation to encourage you to contact local or state public agencies if you wish to obtain a better understanding of the potential impacts resulting from exposure to asbestos.
Because any tenant alterations or other work at the Building could disturb ACM/PACM and possibly release asbestos fibers into the air, we must require that you obtain our written approval prior to beginning such projects. This includes major alterations, but might also include such activities as drilling or boring holes, installing electrical, telecommunications or computer lines, sanding floors, removing ceiling tiles or other work which disturbs ACM/PACM. In many cases, such activities will not affect ACM/PACM, but you must check with the property manager in advance, just in case. You should check with the property manager at the address set forth on Schedule A. The property manager will make available such instruction as may be required. Any such work should not be attempted by an individual or contractor who is not qualified to handle ACM/PACM. In the areas specified in Schedule A, you should avoid touching or disturbing the ACM/PACM in any way. If you observe any activity which has the potential to disturb the ACM/PACM, please report the same to the property manager immediately.
Further information concerning asbestos handling procedures in general can be found in the Buildings O & M Program, located in the Building office at the address set forth on Schedule A. We also encourage you to
EXHIBIT F
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contact local, state or federal public health agencies if you wish to obtain further information regarding asbestos containing materials.
In connection with the foregoing, we have adopted the following policies (which shall be considered rules under tenant leases): (1) the owner, and representatives of the owner, including, without limitation, the owners ACM/PACM consultant, are entitled to enter into the premises of any tenant to inspect for ACM/PACM, perform air tests and abatement; and (2) any tenant, contractor, or other party must obtain our prior written approval before performing any alterations on any tenant space, or performing any other work at the property that might disturb ACM/PACM or involve exposure to asbestos fibers as described above.
California law also requires persons in the course of doing business whose activities may result in exposures to asbestos and other substances regulated under the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly referred to as Proposition 65, to provide a clear and reasonable warning. Accordingly, you are advised as follows:
WARNING: The areas within the Building that are described in Schedule A below contain a substance known to the State of California to cause cancer.
EXHIBIT F
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SCHEDULE A TO EXHIBIT F
SCHEDULE A
TO
NOTICE CONCERNING ASBESTOS
BUILDING: |
525 Market Street | |
GENERAL MANAGER: |
Aline Singman | |
ADDRESS OF BUILDING OFFICE: |
Cushman & Wakefield 525 Market Street San Francisco, CA 94108 Telephone: (415) 546-1096 |
I. | EXISTING OPERATIONS AND MAINTENANCE PROGRAM (O&M PROGRAM) AND ASBESTOS SURVEYS WHICH DESCRIBE THE EXISTENCE, LOCATION AND CONDITION OF ACM |
The O&M Program which has been prepared for the Building since May 1999 is generally described as follows:
A. | O&M PROGRAM |
DATE DESCRIPTION
1. | December 1997, as amended O&M Program prepared by Hygienetics Environmental |
B. | SURVEYS |
DESCRIPTION |
BY COMPANY |
DATE | ||||
1. | Asbestos & Lead Survey Report (Project No. PJ15376) | Forensic Analytical | 8/28/11 | |||
2. | Survey Report (Job 4020.13) | Hygienetics Environmental Services | 9/24/99 | |||
3. | Environmental Compliance Report (Job 4020.014) | Hygienetics Environmental Services | 10/27/99 | |||
4. | Environmental Compliance Report (Job 4003.011) | Hygienetics Environmental Services | 3/11/98 | |||
5. | Environmental Compliance Report (Job 4003.015) | Hygienetics Environmental Services | 10/22/97 | |||
6. | Environmental Compliance Report (Job 4003.010) | Hygienetics Environmental Services | 1/10/97 |
SCHEDULE A TO
EXHIBIT F
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II. | CONTENTS OF O&M PROGRAM |
The Table of Contents of the O&M Program contains the following sections:
Section |
Page | |||||
I. | Executive Summary | 1 | ||||
II. | Introduction | 2 | ||||
III. | Program Administration | 4 | ||||
IV. | Communication | 6 | ||||
V. | Policies | 8 | ||||
VI. | Identification and Locations of ACM | 9 | ||||
Summary of ACM Locations Procedure when Survey Result is not Available |
||||||
VII. | ACM Condition Assessment | 10 | ||||
VIII. | Air Sampling | 11 | ||||
IX. | Medical Surveillance | 12 | ||||
X. | Respiratory Protection | 13 | ||||
XI. | Training | 14 | ||||
XII. | General Procedures for Asbestos Situations | 16 | ||||
A Special Procedures for Isolation of Asbestos Spill/Emergency |
17 | |||||
B. Special Procedures for Emergency Clean-up/Disturbance of ACM |
18 | |||||
C. Special Procedures for Removing/Replacing Ceiling Tiles below Structural Steel Coated Fireproofing |
19 | |||||
D. Maintenance of ACM Flooring |
22 | |||||
XIII. | Waste Handling, Storage & Disposal | 23 | ||||
XIV. | Periodic Surveillance | 24 | ||||
XV. | Documentation/Record Keeping | 25 | ||||
XVI. | Effective Dates and Approval | 26 | ||||
Appendices: |
Page | |||||
ACM Materials at 525 Market Street | A | |||||
ACM Condition Assessment | B | |||||
Introduction to Asbestos |
C | |||||
Sample Notices |
D | |||||
Documentation Forms |
E | |||||
Equipment List |
F | |||||
Glossary |
G | |||||
Written Respiratory Protection Program |
H | |||||
Periodic Air Quality Testing for Airborne Asbestos |
I |
SCHEDULE A TO
EXHIBIT F
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III. | SPECIFIC LOCATIONS WHERE ACM IS PRESENT IN ANY QUANTITY |
Material |
Location | |
Fireproofing and overspray |
Behind sheet rock and/or plaster column enclosures on structural steel and floor decking and nearby locations throughout Building | |
Floor tile, floor sheeting (linoleum) and mastic |
Various locations throughout Building | |
Wall plaster and black packing insulation |
Mechanical Spaces Room | |
Floor Columns |
37th Floor | |
Joint compound |
Sheetrock in core walls throughout Building | |
Mirror mastic |
15th Floor Restrooms and 37th Floor Restrooms |
THE O&M PROGRAM DESCRIBED ABOVE, INCLUDING SAMPLING PROCEDURES AND THE ASBESTOS SURVEYS, ARE AVAILABLE FOR REVIEW DURING NORMAL BUSINESS HOURS IN THE BUILDING OFFICE, AT THE ABOVE ADDRESS, MONDAY THROUGH FRIDAY EXCEPT LEGAL HOLIDAYS. NO REPRESENTATIONS OR WARRANTIES WHATSOEVER ARE MADE REGARDING THE O&M PROGRAM, THE REPORTS CONCERNING SUCH O&M PROGRAM OR THE SURVEYS (INCLUDING WITHOUT LIMITATION, THE CONTENTS OR ACCURACY THEREOF), OR THE PRESENCE OR ABSENCE OF TOXIC OR HAZARDOUS SUBSTANCES IN, AT, OR UNDER ANY PREMISES, BUILDING, OR THE PROJECT.
SCHEDULE A TO
EXHIBIT F
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EXHIBIT G
RIGHT OF FIRST OFFER
1. Right of First Offer. Subject to the terms hereof, Original Tenant shall have the right of first offer (Right of First Offer) to lease any available space on the 37th floor of the Building (the First Offer Space), at the Fair Market Rental Rate (as defined below), for the remainder of the Term, pursuant to the following terms of this Exhibit G. Such space shall be considered to be available if (i) no other Project tenant is leasing such space or (ii) another tenant has a Superior Right (defined as a tenant which has the existing right to lease such space, to expand into such space, or to extend the term of its lease for such space for the period ending on the Expiration Date). Tenants with Superior Rights are set forth in Schedule 1 attached hereto. As to space for which another tenant has any such right, such space shall be available upon expiration of such right without exercise. With regard to space which is leased by a tenant, such space shall be considered to become available upon expiration or earlier termination of the term of such tenants lease of such space, provided that if such lease contains a formal extension option such space shall be considered available only if and when Landlord determines either (a) such tenant has failed to exercise such option and the term of the lease has expired or (b) such tenant has timely and properly exercised such option and the terms of such extension are to be agreed upon, and Landlord and such tenant have failed to reach agreement for the extension of the term of such tenants lease. Tenants Right of First Offer hereunder is subject to pre-existing rights of existing Building tenants. Fair Market Rental Rate means and shall be determined in accordance with Exhibit H (with such changes as are necessary to reflect that the Fair Market Rental Rate is being determined for the First Offer Space).
2. Procedure for Offer. Provided that an Event of Default (or event which, with the giving of notice or the passage of time, or both, would constitute an Event of Default (each, a Default)) has not occurred and is continuing, Tenant may, from time to time (but not more frequently than once per calendar year), request Landlord to advise Tenant of any First Offer Space which may become available over the next twelve (12) month period (Tenant Request). The Tenant Request must be delivered strictly in accordance with Lease Article 30 (Notices). Landlord agrees that, provided no Default or Event of Default has occurred and is continuing, Landlord shall within fifteen (15) business days of the Tenant Request deliver written notice to Tenant (the First Offer Notice) in response to the Tenant Request whether any First Offer Space is currently available or whether, in Landlords professional judgment, may over the next twelve (12) month period become available for lease to third parties. The First Offer Notice shall describe the space which may be available (including, without limitation, Landlords estimated determination of the rentable square footage thereof), the anticipated date on which the First Offer Space will be available for lease by Tenant and the commencement date therefor (First Offer Commencement Date) and shall set forth Landlords determination of the Fair Market Rental Rate with respect to such space. Within fifteen (15) business days after Tenants receipt of each First Offer Notice (the First Offer Response Date), Tenant must give Landlord written notice pursuant to which Tenant (i) elects to lease the First Offer Space at the Fair Market Rental Rate proposed by Landlord for a term coterminous with the Term hereof; or (ii) elects to lease the First Offer Space on the terms proposed by Landlord (other than the determination of Fair Market Rental Rate) in which case the parties shall follow the procedure set forth in Exhibit H; or (iii) elects not to lease such First Offer Space, which election shall be irrevocable. If Tenant does not so respond in writing to Landlords notice on or before the First Offer Response Date, or has responded in accordance with clause (iii) above, Landlord may lease the First Offer Space to any third party. Tenants obligation to pay Rent for the First Offer Space shall commence on the date Landlord tenders possession of the applicable First Offer Space to Tenant.
3. Suspension of Right of First Offer. At Landlords option, Tenant shall not have the right to lease the First Offer Space as provided in this Exhibit so long as Tenant, as of the date of receipt of the First Offer Notice by Tenant, or as of the date of delivery of such First Offer Space to Tenant, or as of the First Offer Commencement Date, a Default or Event of Default has occurred under the Lease and is continuing.
EXHIBIT G
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4. First Offer Right Personal to Tenant. Tenants First Offer Right set forth in this Exhibit G is personal to, and shall only be exercised by, the Original Tenant (and may not be exercised by any other assignee, subtenant or other transferee of Tenants interest in the Lease or the premises leased by Tenant) and shall only be available to Original Tenant when Original Tenant is in physical occupancy of the entire Premises. As used herein, physical occupancy shall mean that Tenant shall not have entered into any assignment or entered into any subleases other than any transaction permitted under Section 12.07 of the Lease.
5. Miscellaneous. Time is of the essence in this Exhibit G.
EXHIBIT G
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SCHEDULE 1 to EXHIBIT G
Superior Rights Holders:
| Towers Watson |
EXHIBIT G
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EXHIBIT H
OPTION TO EXTEND TERM
1. Option Rights. Landlord hereby grants Tenant one (1) option to extend the Term for a period of five (5) years (the Option Term), which option shall be exercisable only by written Exercise Notice (as defined below) delivered by Tenant to Landlord as provided below. Upon the proper exercise of the option to extend the Lease pursuant to this Exhibit H, the Term shall be extended for the Option Term.
2. Option Rent. The Annual Base Rent for the Premises payable by Tenant during the Option Term (the Option Rent) shall be equal to the Fair Market Rental Rate for the Premises at the commencement of the Option Term. As used herein, the Fair Market Rental Rate for purposes of determining the Annual Base Rent for the Option Term shall mean the annual Base Rent at which non-equity tenants, as of the commencement of the Option Term will be leasing non-sublease, non-equity, unencumbered space comparable in size, location and quality to the Premises for a comparable term, which comparable space is located in the Building and in other Comparable Buildings, taking into account and adjusting the Base Year to be the calendar year in which the Option Term commences, and taking into consideration all free rent and other out-of-pocket concessions generally being granted at such time for such comparable space for the Option Term (including, without limitation, any tenant improvement allowance provided for such comparable space, with the amount of such tenant improvement allowance to be provided for the Premises during the Option Term to be determined after taking into account the age, quality and layout of the tenant improvements in the Premises as of the commencement of the Option Term). All other terms and conditions of the Lease shall apply throughout the Option Term; however, (A) the Base Year shall be revised to be the first full calendar year after the Option Term commences, (B) Tenant shall, in no event, have the option to extend the Term beyond the Option Term described in Section 1 above, unless otherwise agreed by Landlord, and (C) Landlord reserves the right of applying any then-current Building measurement standards for determining the Rentable Area of the Premises and/or the Rentable Office Area of the Building.
3. Exercise of Option. The option contained in this Exhibit H shall be exercised by Tenant, if at all, only in the following manner: (i) Tenant shall deliver written notice to Landlord (the Interest Notice) not less than 365 days prior to the expiration of the Term stating that Tenant may be interested in exercising its option; (ii) Landlord, within sixty (60) days after receipt of the Interest Notice, shall deliver to Tenant notice (the Option Rent Notice) setting forth Landlords determination of the Fair Market Rental Rate; and (iii) if Tenant wishes to exercise such option, Tenant shall, on or before the date (the Exercise Date) which is the 270th day prior to the expiration of the Term, exercise the option by delivering written notice (Exercise Notice) thereof to Landlord, which exercise shall be irrevocable and unconditional. During the period of time between the date Landlord delivers the Option Rent Notice and the Exercise Date, Landlord and Tenant shall discuss Landlords determination of the Fair Market Rental Rate. Concurrently with Tenants delivery of the Exercise Notice, if Landlord and Tenant have not already agreed in writing upon the Fair Market Rental Rate, Tenant may object, in writing (within the Exercise Notice), to Landlords determination of the Fair Market Rental Rate set forth in the Option Rent Notice, in which event such Fair Market Rental Rate shall be determined pursuant to Section 4 below. Tenants failure to deliver the Exercise Notice on or before the Exercise Date, shall be deemed to constitute Tenants waiver of its option to extend under this Exhibit H. Tenants failure to timely object in writing to Landlords determination of the Fair Market Rental Rate set forth in the Option Rent Notice shall be deemed Tenants acceptance of Landlords determination of the Fair Market Rental Rate and the following provisions of Section 4 shall not apply.
4. Determination of Fair Market Rental Rate. If Tenant timely objects to the Fair Market Rental Rate submitted by Landlord in the Option Rent Notice, Landlord and Tenant shall thereafter attempt in good faith to agree upon such Fair Market Rental Rate, using their best good faith efforts. If Landlord and Tenant fail to reach agreement on such Fair Market Rental Rate within thirty (30) days following Tenants objection to such Fair Market Rental Rate (the Outside Agreement Date), then each party shall place in a separate sealed envelope
EXHIBIT H
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its final proposal as to the appropriate Fair Market Rental Rate and such shall be submitted to arbitration in accordance with Sections 4.1 through 4.5 below.
4.1 Landlord and Tenant shall meet with each other within five (5) business days after the Outside Agreement Date and exchange the sealed envelopes and then open such envelopes in each others presence. If the two (2) different amounts submitted by the parties as set forth in such sealed envelopes are equal to or less than two percent (2%) apart, then (a) those two (2) amounts shall be averaged, (b) the resulting averaged amount shall be the Fair Market Rental Rate for the Option Term, and (c) the following arbitration procedures in this Section 4 shall not apply. If, however, such amounts are more than two percent (2%) apart, and Landlord and Tenant do not mutually agree upon the Fair Market Rental Rate within five (5) business days after the exchange and opening of envelopes, then, within fifteen (15) business days after the exchange and opening of envelopes Landlord and Tenant shall agree upon and jointly appoint a single arbitrator who shall by profession be a real estate broker who shall have been active over the fifteen (15) year period ending on the date of such appointment in consummating leasing transactions in commercial high-rise properties in the Financial District of San Francisco and where such broker does not represent and has not represented either Landlord or Tenant. Neither Landlord nor Tenant shall consult with such broker as to his or her opinion as to Fair Market Rental Rate prior to the appointment. The determination of the arbitrator shall be limited solely to the issue of whether Landlords or Tenants submitted Fair Market Rental Rate is the closer to the actual Fair Market Rental Rate as determined by the arbitrator, taking into account the requirements of this provision. Such arbitrator may hold such hearings and gather such third party evidence regarding Fair Market Rental Rate as the arbitrator, in his or her sole discretion, determines is necessary. In addition, Landlord or Tenant may submit to the arbitrator with a copy to the other party within five (5) business days after the appointment of the arbitrator any market data and additional information that such party deems relevant to the determination of Fair Market Rental Rate (FMRR Data) and the other party may submit a reply in writing within five (5) business days after receipt of such FMRR Data.
4.2 The arbitrator shall, within thirty (30) days after his or her appointment, reach a decision as to whether the parties shall use Landlords or Tenants submitted Fair Market Rental Rate, and shall notify Landlord and Tenant of such determination, which determination shall be binding upon Landlord and Tenant.
4.3 The procedural laws set forth in the California General Arbitration Act (California Code of Civil Procedure Sections 1280 through 1294.2) shall govern such arbitration.
4.4 If Landlord and Tenant fail to agree upon and appoint an arbitrator, then the appointment of the arbitrator shall be made by the Presiding Judge of the San Francisco Superior Court, or, if he or she refuses to act, by any judge having jurisdiction over the parties.
4.5 The cost of arbitration shall be paid by Landlord and Tenant equally.
5. Suspension of Right to Extend Term. Notwithstanding anything in the foregoing to the contrary, at Landlords option, and in addition to all of Landlords remedies under the Lease, at law or in equity, the option to extend the Term granted to Tenant in this Exhibit H shall not be deemed to be properly exercised if, as of the date Tenant delivers the Exercise Notice or as of the end of the Term, Tenant is in default under the Lease beyond the expiration of any applicable notice and cure periods. In addition, Tenants right to extend the Term pursuant to this Exhibit H is personal to the original Tenant executing the Lease and to any transferee of any transaction permitted under Section 12.07 of the Lease (collectively, the Original Tenant), and may not be assigned or exercised, voluntarily or involuntarily, by or to, any person or entity other than the Original Tenant, and shall only be available to and exercisable by Original Tenant when the Original Tenant in actual and physical possession of the entirety of the Rentable Area of the Premises.
6. Miscellaneous. Time is of the essence in this Exhibit H.
EXHIBIT H
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EXHIBIT I
FORM OF LETTER OF CREDIT
[Letter of Credit Commences on the Following Page]
EXHIBIT I
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ISSUING BANK:
BANK OF AMERICA, N.A.
1000 W. TEMPLE STREET
7th FLOOR, CA9-705-07-05
LOS ANGELES, CA 90012-1514
APPLICANT:
MEDIVATION, INC.
525 MARKET STREET, SUITE
SAN FRANCISCO, CALIFORNIA 94105
ATTENTION:
BENEFICIARY:
KNICKERBOCKER PROPERTIES, INC. XXXIII
C/O CUSHMAN & WAKEFIELD OF CALIFORNIA, INC.
525 MARKET STREET, SUITE 3750
SAN FRANCISCO, CALIFORNIA 94105
ATTENTION: PROPERTY MANAGER
AMOUNT: USD $5,145,480.00
EXPIRATION: JUNE 1, 2013
WE HEREBY ESTABLISH OUR IRREVOCABLE STANDBY LETTER OF CREDIT NO.
IN YOUR FAVOR AVAILABLE BY YOUR DRAFT DRAWN ON US AT SIGHT (IN THE FORM ATTACHED HERETO AS ANNEX A) AND ACCOMPANIED BY THE FOLLOWING DOCUMENTS:
A DATED CERTIFICATE IN THE FORM ATTACHED HERETO AS ANNEX B FROM THE BENEFICIARY SIGNED BY AN AUTHORIZED OFFICER, FOLLOWED BY ITS DESIGNATED TITLE. THE ORIGINAL (OR FACSIMILE COPY IF PRESENTATION IS MADE BY FACSIMILE TRANSMISSION) OF THIS IRREVOCABLE STANDBY LETTER OF CREDIT AND ANY AMENDMENTS THERETO.
PARTIAL DRAWING AND MULTIPLE PRESENTATIONS ARE ALLOWED.
THIS LETTER OF CREDIT SHALL BE AUTOMATICALLY EXTENDED FOR ADDITIONAL PERIODS OF ONE YEAR, WITHOUT AMENDMENT, FROM THE PRESENT OR EACH FUTURE EXPIRATION DATE UNLESS AT LEAST NINETY (90) DAYS PRIOR TO THE THEN CURRENT EXPIRATION DATE WE NOTIFY YOU BY REGISTERED MAIL/OVERNIGHT COURIER SERVICE AT THE ABOVE ADDRESSES THAT THIS LETTER OF CREDIT WILL NOT BE EXTENDED BEYOND THE CURRENT EXPIRATION DATE, IN NO EVENT SHALL THIS LETTER OF CREDIT BE AUTOMATICALLY EXTENDED BEYOND SEPTEMBER 1, 2019.
THIS LETTER OF CREDIT IS TRANSFERABLE ONE OR MORE TIMES, BUT IN EACH INSTANCE ONLY TO A SINGLE TRANSFEREE AND ONLY IN THE FULL AMOUNT AVAILABLE TO BE DRAWN UNDER THIS LETTER OF CREDIT AT THE TIME OF SUCH TRANSFER. SHOULD YOU WISH TO EFFECT A TRANSFER UNDER THIS CREDIT, SUCH TRANSFER WILL BE SUBJECT TO THE RETURN TO US OF THE ORIGINAL LETTER OF CREDIT INSTRUMENT, ACCOMPANIED BY OUR FORM OF TRANSFER ATTACHED HERETO AS ANNEX C, PROPERLY COMPLETED AND SIGNED BY AN AUTHORIZED SIGNATORY OF BENEFICIARY AND PAYMENT OF OUR TRANSFER FEE. EACH TRANSFER SHALL BE EVIDENCED BY OUR ENDORSEMENT ON THE REVERSE OF THE ORIGINAL OF THIS LETTER OF CREDIT, AND WE SHALL DELIVER SUCH ORIGINAL TO THE TRANSFEREE. THE TRANSFEREES NAME SHALL AUTOMATICALLY BE SUBSTITUTED FOR THAT OF THE BENEFICIARY WHEREVER SUCH BENEFICIARYS NAME APPEARS
WITHIN THIS STANDBY LETTER OF CREDIT. ALL CHARGES IN CONNECTION WITH ANY TRANSFER OF THIS LETTER OF CREDIT SHALL BE CHARGED TO THE APPLICANTS ACCOUNT.
ALL DEMANDS FOR PAYMENT SHALL BE MADE BY PRESENTATION OF THE ORIGINAL APPROPRIATE DOCUMENTS, ON A BUSINESS DAY AT OUR OFFICE (THE BANKS OFFICE) AT: BANK OF AMERICA, N.A., ca9-705-07-05, 1000 WEST TEMPLE STREET, 7TH FLOOR, LOS ANGELES, CA 90012, ATTENTION: STANDBY LETTER OF CREDIT DEPT., OR BY FACSIMILE TRANSMISSION TO: (213) 457-4481; AND SIMULTANEOUSLY UNDER TELEPHONE ADVICE TO: (800) 541-6096 OPT. 1, PROVIDED THAT THE GIVING OF SUCH TELEPHONIC ADVICE SHALL NOT BE A CONDITION TO OUR OBLIGATION TO MAKE PAYMENT HEREUNDER. IN SUCH EVENT THE ORIGINAL DOCUMENTS ARE NOT REQUIRED FOR PRESENTATION.
IF THE REQUISITE DOCUMENTS ARE PRESENTED BY FACSIMILE OR OTHERWISE BEFORE EXPIRATION OF THIS LETTER OF CREDIT, BANK, WILL HONOR THE DRAFT(S) DRAWN UNDER AND IN COMPLIANCE WITH THE TERMS OF THIS LETTER OF CREDIT UPON PRESENTATION, AND PAYMENT WILL BE EFFECTED THE SAME DAY IF PRESENTATION IS MADE BEFORE 7:00 A.M. (PACIFIC) THAT DAY. IF PRESENTATION IS MADE AFTER 7:00 A.M. (PACIFIC), THEN PAYMENT WILL BE EFFECTED BEFORE THE CLOSE OF BUSINESS OF THE FOLLOWING BUSINESS DAY.
EXCEPT AS OTHERWISE SET FORTH HEREIN, THIS LETTER OF CREDIT IS SUBJECT TO THE UNIFORM CUSTOMES AND PRACTICE FOR DOCUMENTARY CREDITS (2007 REVISION), INTERNATIONAL CHAMBER OF COMMERCE, PUBLICATION NO. 600.
Very truly yours,
BANK OF AMERICA, N.A.
BY: | ||
(AUTHORIZED SIGNATURE) |
ANNEX A
SIGHT DRAFT
, 20
At sight, pay to the order of [Name of Beneficiary] the amount of [ ($ )].
Drawn under Bank of America, N.A. Letter of Credit No. .
[Beneficiary]
,
a
By: | ||
Name: | ||
Title: |
ANNEX B
CERTIFICATE
Letter of Credit: Irrevocable Standby Letter of Credit No.
Issuer: Bank of America, N.A.
Beneficiary:
The undersigned, being a duly authorized officer of [Name of Beneficiary] certifies to Issuer as follows:
1. Pursuant to the Letter of Credit, Beneficiary has concurrently presented its sight draft drawn on Issuer in the amount of [ ($ )].
2. This draw in the amount of U.S. Dollars ($ ) under your Irrevocable Standby Letter of Credit No. represents funds due and owing to us pursuant to the terms of that certain lease dated by and between Knickerbocker Properties, Inc. XXXIII and Medivation, Inc. and/or any amendment to such lease or any other agreement between such parties related to such lease;
3.
Dated:
[Name of Authorized Officer of Beneficiary], |
as [Title of Authorized Officer] of [Name of Beneficiary] |
ANNEX C
TRANSFER FORM
, 20__
Bank of America N.A.
Standby Letter of Credit Department
1000 W. Temple Street, 7th Floor
Los Angeles, CA 90012
Mail Code CA9-705-07-05
Re: | Irrevocable Standby Letter of Credit No. |
We request you to transfer all of our rights as beneficiary under the Letter of Credit referenced above to the transferee, named below:
Name of Transferee
Address
By this transfer all our rights as the transferor, including all rights to make drawings under the Letter of Credit, go to the transferee. The transferee shall have sole rights as beneficiary, whether existing now or in the future, including sole rights to agree to any amendments, including increases or extensions or other changes. All amendments will be sent directly to the transferee without the necessity of consent by or notice to us.
We enclose the original letter of credit and any amendments. Please indicate your acceptance of our request for the transfer by endorsing the letter of credit and sending it to the transferee with your customary notice of transfer.
The signature and title at the right conform with those shown in our files as authorized to sign for the beneficiary. Policies governing signature authorization as required for withdrawals from customer accounts shall also be applied to the authorization of signatures on this form. The authorization of the Beneficiarys signature and title on this form also acts to certify that the authorizing financial institution (i) is regulated by a U.S. federal banking agency; (ii) has implemented anti-money laundering policies and procedures that comply with applicable requirements of law, including a Customer Identification Program (CIP) in accordance with Section 326 of the USA PATRIOT Act; (iii) has approved the Beneficiary under its anti-money laundering compliance program; and (iv) acknowledges that Bank of America, N.A. is relying on the foregoing certifications pursuant to 31 C.F.R. Section 103.121 (b)(6). |
NAME OF TRANSFEROR
NAME OF AUTHORIZED SIGNER AND TITLE | |
ACCOMPANIED BY A COPY OF EITHER Articles of Incorporation, Corporate Borrowers Resolution or other document that demonstrates the signor opposite this statement is authorized to sign on behalf of the TRANSFEROR |
AUTHORIZED SIGNATURE |
Exhibit 10.28
MEDIVATION, INC.
STOCK APPRECIATION RIGHT GRANT NOTICE
(AMENDED AND RESTATED 2004 EQUITY INCENTIVE AWARD PLAN)
Medivation, Inc. (the Company), pursuant to its Amended and Restated 2004 Equity Incentive Award Plan (the Plan), hereby grants to Participant the number of Stock Appreciation Rights set forth below (the Award). This Award is subject to all of the terms and conditions as set forth herein and in the Stock Appreciation Right Agreement and the Plan, each of which is attached hereto and incorporated herein in its entirety.
Participant: |
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Date of Grant: |
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Vesting Commencement Date: |
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Number of Stock Appreciation Rights: |
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Strike Price (Per share): |
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Total Strike Price: |
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Expiration Date: |
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Vesting Schedule: | [25% of the Award (rounded down to the next whole number of shares) shall vest one year after the Vesting Commencement Date, and 1/48th of the Award (rounded down to the next whole number of shares) shall vest on the first day of each full month thereafter, so that all of the Award shall be vested on the first day of the 48th month after the Vesting Commencement Date.] |
Additional Terms/Acknowledgements: The Participant acknowledges receipt of, and understands and agrees to, this Stock Appreciation Right Grant Notice, the Stock Appreciation Right Agreement and the Plan (together, the Award Documents). Participant acknowledges and agrees that this Stock Appreciation Right Grant Notice and the Stock Appreciation Right Agreement may not be modified, amended or revised except in a writing signed by Participant and a duly authorized officer of the Company. Participant further acknowledges that as of the Date of Grant, the Award Documents set forth the entire understanding between Participant and the Company regarding the Award.
The Participant may designate receipt and acceptance of the Award and the terms of the Award Documents via electronic confirmation in accordance with instructions that accompany an electronic delivery of this Stock Appreciation Right Grant Notice by the Company to Participant.
ATTACHMENTS: | Stock Appreciation Right Agreement and Amended and Restated 2004 Equity Incentive Award Plan |
1.
MEDIVATION, INC.
AMENDED AND RESTATED 2004 EQUITY INCENTIVE AWARD PLAN
STOCK APPRECIATION RIGHT AGREEMENT
Pursuant to your Stock Appreciation Right Grant Notice (Grant Notice) and this Stock Appreciation Right Agreement (the Agreement), Medivation, Inc. (the Company) has granted you under its Amended and Restated 2004 Equity Incentive Award Plan (the Plan) the number of Stock Appreciation Rights indicated in your Grant Notice at the strike price indicated in your Grant Notice (the Award). This Agreement shall be deemed to be agreed to by the Company and you upon your electronic acceptance of the Award. Defined terms not explicitly defined in this Stock Appreciation Agreement or the Grant Notice but defined in the Plan shall have the same definitions as in the Plan.
The details of your Award are as follows:
1. GRANT OF THE AWARD. This Award represents your right to receive on a future date either (i) a cash payment or (ii) shares of Stock, as applicable pursuant to Section 4 below. As of the date of grant, the Company will credit to a bookkeeping account maintained by the Company for your benefit (the Account) the number of Stock Appreciation Rights subject to the Award. This Award was granted in consideration of your services to the Company. Except as otherwise provided herein, you will not be required to make any payment to the Company (other than past and future services to the Company) with respect to your receipt of the Award, the vesting of the Stock Appreciation Rights or the delivery of the cash payment or Stock in settlement of the Award.
2. VESTING. Subject to the limitations contained herein, your Award will vest as provided in your Grant Notice (subject to acceleration pursuant to Section 11.2 of the Plan), provided that vesting will cease upon a Termination of Service.
For purposes of this Agreement Termination of Service means the time when the service relationship (whether as an Employee or a consultant) between the Participant and the Company or any Subsidiary is terminated for any reason, with or without Cause, including, but not by way of limitation, a termination by resignation, discharge, death or Disability; but excluding (a) a termination where there is a simultaneous reemployment or continuing employment or consultancy of the Participant by the Company or any Subsidiary or a parent corporation thereof (within the meaning of Section 422 of the Code), (b) at the discretion of the Committee, a termination which results in a temporary severance of the employee-employer relationship, and (c) at the discretion of the Committee, a termination which is followed by the simultaneous establishment of a consulting relationship by the Company or a Subsidiary with the former Employee. The Committee, in its absolute discretion, shall determine the effect of all matters and questions relating to Termination of Service for the purposes of this Agreement, including, but not by way of limitation, the question of whether, for Participants who are Employees of the Company or any of its Subsidiaries, a Termination of Service resulted from a discharge for Cause, and all questions of whether particular leaves of absence for Participants who are Employees of the Company or any of its Subsidiaries constitute Terminations of Service. Notwithstanding any other provision of the Plan or this Agreement, the Company or any Subsidiary has an absolute and unrestricted right to terminate the Participants employment and/or consultancy at any time for any reason whatsoever, with or without Cause, except to the extent expressly provided otherwise in a written agreement between the Company and the Participant.
For purposes of this Agreement, Cause, as determined by the Board good faith, Employee has:
(1) | failed to perform his or her stated duties in all material respects, which failure continues for fifteen (15) days after Employees receipt of written notice of the failure from the Company; |
(2) | intentionally and materially breached any provision of any written agreement with the Company, and has not cured such breach within fifteen (15) days after Employees receipt of written notice of the breach from the Company (provided that, the Companys written notice is not required if Employees breach is not reasonably capable of cure); |
(3) | demonstrated Employees personal dishonesty in connection with his or her employment with the Company; |
(4) | engaged in willful misconduct in connection with his or her employment with the Company; |
(5) | engaged in a breach of fiduciary duty in connection with his or her employment with the Company; or |
(6) | willfully violated any material law, rule or regulation, or final cease-and-desist order (other than minor traffic violations or similar offenses), been convicted or pled guilty (including a no contest plea) to any felony, or engaged in other serious misconduct of such a nature that Employees continued employment may reasonably be expected to cause the Company substantial economic or reputational injury. |
3. NUMBER OF STOCK APPRECIATION RIGHTS AND STRIKE PRICE. The number of Stock Appreciation Rights granted in respect of your Award and their strike price per share referenced in your Grant Notice may be adjusted from time to time pursuant to Article 11 of the Plan.
4. CALCULATION OF APPRECIATION AND SETTLEMENT. Until such time, if any, following the Date of Grant as the stockholders of the Company approve an increase in the number of shares of Stock available for issuance under the Plan or a successor equity plan to the Plan, the Award will be settled only by cash payment. Following such approval, the Award will be settled only in Stock. The cash amount payable or the value of the Stock issued, as applicable, upon exercise of your Award shall be equal the number of vested Stock Appreciation Rights subject to your Award multiplied by the excess, if any, of (i) the Fair Market Value on the exercise date over (ii) the Strike Price on the date of grant (as indicated in your Grant Notice) (the Appreciation Value). If the Award is settled in Stock, the number of shares of Stock deliverable upon exercise of your Award shall be determined by dividing the Appreciation Value by the Fair Market Value per share of Stock on the Exercise Date (as defined in Section 5); provided, however, that no factional shares shall be issued and, in lieu thereof, the Participant shall receive a cash payment representing the Fair Market Value of such fractional share on the Exercise Date.
5. EXERCISE. Participant may only exercise this Award to the extent vested in accordance with Section 2. To exercise this Award, Participant must provide a written Notice of Exercise to the Company in the form provided by the Company. The Exercise Date will be the business day on which Participants written and signed Notice of Exercise is received by the Company at the location designated in the Notice of Exercise before or during normal business hours for that location on that day. If the Notice of Exercise is received after normal business hours for a given day, then the Exercise Date will be treated as the following business day.
6. CASH SETTLEMENT; DELIVERY OF SHARES. Upon exercise of this Award at a time when it may only be settled in cash, the Company shall pay to you (or, in the case of death, to your beneficiary pursuant to Section 8) a cash amount equal to the Appreciation Value determined in accordance with Section 4, but subject to withholding pursuant to Section 11. Upon exercise of this Award at a time when it may only be settled in Stock, the Company shall issue and deliver to you (or, in the case of death, to your beneficiary pursuant to Section 8) the certificates representing the shares of Stock determined in accordance with Section 4 (the Certificates). The Certificates, when issued, shall be registered in your name (or your beneficiary, in the case of death) and, subject to Section 10, will be delivered within thirty (30) days following the Exercise Date. However, in the event that the Company determines that you are subject to its policy regarding insider trading of the Companys stock and any shares are scheduled to be delivered to you on a day (the Original Distribution Date) that does not occur during an open window period applicable to you, as determined by the Company in accordance with such policy, then the Certificates covering such shares shall not be delivered on such Original Distribution Date and shall instead be delivered as soon as practicable within the next open window period applicable to you pursuant to such policy. The form of delivery (e.g., a stock certificate or electronic entry evidencing such shares) shall be determined by the Company.
7. RESTRICTIVE LEGENDS. Any shares of Stock issued pursuant to this Award shall be endorsed with appropriate legends, if any, determined by the Company.
8. TERM. To the extent vested in accordance with Section 2, exercised pursuant to Section 5, and settled via cash payment or Stock issuance pursuant to Section 4, such portion of your Award shall expire concurrently therewith, and to the extent not vested at the time of your Termination of Service, such portion of your Award shall expire immediately; provided, however, in all events, if not previously expired, your Award shall expire on the Expiration Date indicated in your Grant Notice.
9. TRANSFERABILITY. Your Award is not transferable except by will or by the laws of descent and distribution. Notwithstanding the foregoing, by delivering written notice to the Company, in a form satisfactory to the Company, you may designate a third party who, in the event of your death, shall thereafter be entitled to receive any distribution of shares of Stock pursuant to Section 6 of this Agreement.
10. AWARD NOT A SERVICE CONTRACT. Your Award is not an employment or service contract, and nothing in your Award shall be deemed to create in any way whatsoever any obligation on your part to continue in the employ of the Company or any Subsidiary, or of the Company or any Subsidiary to continue your employment. In addition, nothing in your Award shall obligate the Company or any Subsidiary, their respective stockholders, Boards of Directors, Officers or Employees to continue any relationship that you might have as a Director or consultant for the Company or any Subsidiary.
11. WITHHOLDING OBLIGATIONS.
(a) At the time your Award is exercised, in whole or in part, or at any time thereafter as requested by the Company, you hereby authorize withholding from payroll, any cash amounts payable to you pursuant to this Award or that number of whole shares of Stock otherwise deliverable to you pursuant to this Award having a Fair Market Value not in excess of the Taxation (defined below) determined by the applicable minimum statutory rates, and you otherwise agree to make adequate provision for any sums required to satisfy the federal, state, local and foreign tax withholding obligations of the Company or any Subsidiary that arise in connection with the exercise of your Award.
(b) Your Award will not exercised unless and until the Company and/or any Subsidiary are satisfied in their absolute discretion that either (i) you have made payment, or have made arrangements satisfactory to the Company and/or any Subsidiary for the payment to it of such sum as is sufficient to meet any withholding liability to Taxation in any jurisdiction which is or would be recoverable from you following exercise of your Award, and in respect of which the Company and/or any Subsidiary is liable to account in any jurisdiction; or (ii) you have entered into an agreement with the Company and/or any Subsidiary (in a form satisfactory to the Company or such Subsidiary) to ensure that such a payment is made by you including, without limitation, amounts in respect of any employers social security (or the local law equivalent thereof) or other forms of Taxation. Accordingly, your Award may not be exercised even though your Award is vested, and the Company shall have no obligation to make any cash payment or deliver shares of Stock in settlement of your Award as provided for herein unless such obligations are satisfied. Taxation shall include all forms of taxation including employees and employers social security, income tax and any other taxes of whatever nature in any jurisdiction together with any amount payable by any Subsidiary in respect of which the Subsidiary has a duty to account as a result of any laws of any jurisdiction relating to taxation.
12. PERSONAL DATA. You understand that your employer, if applicable, the Company, and/or any Subsidiaries hold certain personal information about you, including but not limited to your name, home address, telephone number, date of birth, social security or equivalent tax identification number, salary, nationality, job title, and details of your Award (collectively, the Personal Data). Certain Personal Data may also constitute Sensitive Personal Data or similar classification under applicable local law and be subject to additional restrictions on collection, processing and use of the same under such laws. Such data include but are not limited to Personal Data and any changes thereto, and other appropriate personal and financial data about you. You hereby provide express consent to the Company or any Subsidiaries to collect, hold, and process any such Personal Data and Sensitive Personal Data. You also hereby provide express consent to the Company and/or any Subsidiaries to transfer any such Personal Data and Sensitive Personal Data outside the country in which you are employed or retained. The legal persons for whom such Personal Data are intended are the Company and any broker company providing services to the Company in connection with the administration of the Plan. You have been informed of your right to access and correct your Personal Data and/or Sensitive Personal Data by applying to the Company representative identified on the Grant Notice.
13. ADDITIONAL ACKNOWLEDGEMENTS. You hereby consent and acknowledge that:
(a) Participation in the Plan is voluntary and therefore you must accept the terms and conditions of the Plan and this Award as a condition to participating in the Plan and receipt of this Award.
(b) The Plan is discretionary in nature and the Company can amend, cancel, or terminate it at any time.
(c) This Award and any other Awards under the Plan are voluntary and occasional and do not create any contractual or other right to receive future awards or other benefits in lieu of future awards, even if similar awards have been granted repeatedly in the past.
(d) All determinations with respect to any such future awards, including, but not limited to, the time or times when such awards are made, the size of such awards and performance and other conditions applied to the awards, will be at the sole discretion of the Company.
(e) The value of this Award is an extraordinary item of compensation, which is outside the scope of your employment, service contract or consulting agreement, if any. This Award shall
not form part of any past, current or future entitlement to remuneration or benefits which you may have under any contract of employment with the Company nor form any part of any such contract of employment between you and the Company.
(f) This Award, and any income derived therefrom are a potential bonus payment not paid in lieu of any cash salary compensation and not part of normal or expected compensation or salary for any purposes, including, but not limited to, calculating any termination, severance, resignation, redundancy, end of service payments, bonuses, long-service awards, life or accident insurance benefits, pension or retirement benefits or similar payments.
(g) In the event of the involuntary Termination of Service, your eligibility to receive [payments or] Stock under the Award or the Plan, if any, will terminate effective as of the date that you are no longer actively employed or retained regardless of any reasonable notice period mandated under local law, except as expressly provided in this Agreement.
(h) The future value of your Award and the Stock Appreciation Rights is unknown and cannot be predicted with certainty. You do not have, and will not assert, any claim or entitlement to compensation, indemnity or damages arising from the termination of this Award or diminution in value of this Award and you irrevocably release the Company, its Subsidiaries and, if applicable, your employer, if different from the Company, from any such claim that may arise.
(i) The Plan and this Award set forth the entire understanding between you, the Company and any Subsidiary regarding the Award or any other cash payment in respect of the Stock Appreciation Rights and supersedes all prior oral and written agreements pertaining to this Award.
14. DELIVERY OF DOCUMENTS AND NOTICES. Any document relating to participating in the Plan and/or notice required or permitted hereunder shall be given in writing and shall be deemed effectively given (except to the extent that this Agreement provides for effectiveness only upon actual receipt of such notice) upon personal delivery, electronic delivery, or upon deposit in the U.S. Post Office or foreign postal service, by registered or certified mail, with postage and fees prepaid, addressed to the other party at the e-mail address, if any, provided for you by the Company or a Subsidiary or at such other address as such party may designate in writing from time to time to the other party.
(a) Description of Electronic Delivery. The Plan documents, which may include but do not necessarily include the Plan prospectus, Grant Notice, Agreement, Certificates and U.S. financial reports of the Company, may be delivered to you electronically. Such means of delivery may include but do not necessarily include the delivery of a link to a Company intranet or the internet site of a third party involved in administering the Plan, the delivery of the document via e-mail or such other delivery determined at the Committees discretion.
(b) Consent to Electronic Delivery. You acknowledge that you have read Section 14 of this Agreement and consent to the electronic delivery of the Plan documents, as described in Section 14 of this Agreement. You acknowledge that you may receive from the Company a paper copy of any documents delivered electronically at no cost if you contact the Company by telephone, through a postal service or electronic mail at [ ]. You further acknowledge that you will be provided with a paper copy of any documents delivered electronically if electronic delivery fails; similarly, you understand that you must provide the Company or any designated third party with a paper copy of any documents delivered electronically if electronic delivery fails. Also, you understand that your consent may be revoked or changed, including any change in the electronic mail address to which documents are delivered (if you have provided an electronic mail address), at any time by notifying the Company of such revised or revoked consent by telephone, postal service or electronic mail at [ ]. Finally, you understand that you are not required to consent to electronic delivery.
15. SECURITIES LAW COMPLIANCE. The grant of your Award and the issuance of any shares of Stock pursuant the Award shall be subject to compliance with all applicable requirements of federal, state or foreign law with respect to such securities. You may not be issued any shares of Stock pursuant to the Award if the issuance of shares of Stock would constitute a violation of any applicable federal, state or foreign securities laws or other law or regulations or the requirements of any stock exchange or market system upon which the Stock may then be listed. In addition, you may not be issued any shares of Stock pursuant to the Award unless (i) a registration statement under the Securities Act shall at the time of issuance be in effect with respect to the shares of Stock or (ii) in the opinion of legal counsel to the Company, the shares of Stock may be issued in accordance with the terms of an applicable exemption from the registration requirements of the Securities Act. YOU ARE CAUTIONED THAT THE SHARES OF STOCK MAY NOT BE ISSUED UNLESS THE FOREGOING CONDITIONS ARE SATISFIED. The inability of the Company to obtain from any regulatory body having jurisdiction the authority, if any, deemed by the Companys legal counsel to be necessary to the lawful issuance and sale of any shares of Stock pursuant to the Award shall relieve the Company of any liability in respect of the failure to issue or sell such shares as to which such requisite authority shall not have been obtained. As a condition to the issuance of any shares of Stock pursuant to the Award, the Company may require you to satisfy any qualifications that may be necessary or appropriate, to evidence compliance with any applicable law or regulation and to make any representation or warranty with respect thereto as may be requested by the Company.
16. GOVERNING PLAN DOCUMENT. Your Award is subject to all the provisions of the Plan, the provisions of which are hereby made a part of your Award, and is further subject to all interpretations, amendments, rules and regulations, which may from time to time be promulgated and adopted pursuant to the Plan. In the event of any conflict between the provisions of your Award and those of the Plan, the provisions of the Plan shall control.
Exhibit 10.29
MEDIVATION, INC.
AMENDED AND RESTATED 2004 EQUITY INCENTIVE AWARD PLAN
PERFORMANCE SHARE AWARD GRANT NOTICE
Medivation, Inc. (the Company), pursuant to its Amended and Restated 2004 Equity Incentive Award Plan (the Plan), hereby awards to Participant the award (the Award) set forth below. This Award is subject to all of the terms and conditions as set forth herein and in the Performance Share Award Agreement and the Plan, each of which is attached hereto and incorporated herein in its entirety. Unless otherwise defined herein, capitalized terms shall have the meanings set forth in the Plan or the Performance Share Award Agreement (the Agreement), as applicable.
Participant: |
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Date of Grant: |
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Number of Shares of Stock Subject to Target Award: | [ ] shares of Stock | |
Number of Shares of Stock Subject to Maximum Award: | [200% of number of shares of Stock subject to Target Award] | |
Term: |
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Determination of Actual Award: On the Certification Date, and provided that (i) the specified level of applicable Performance Goals is attained during the Performance Period and (ii) Participant has not experienced a Termination of Service prior to the Certification Date, the Company shall credit Participant with an Actual Award representing all or a portion (including none) of the Target Award or the Maximum Award (in the event of performance exceeding that of the Target Award, as indicated herein), as determined by the Committee based on the degree of achievement of the Performance Goals set forth on Exhibit A to the Agreement, subject to the conditions and limitations set forth in the Agreement.
Delivery of Shares: Subject to the limitations contained herein and the provisions of the Agreement and the Plan, the Company shall deliver to the Participant the shares of Stock subject to the Actual Award as provided in Section 4 of the Agreement.
Additional Terms/Acknowledgements: The Participant acknowledges receipt of, and understands and agrees to, this Award Grant Notice, the Agreement and the Plan (together, the Award Documents). Participant further acknowledges that as of the Date of Grant, the Award Documents set forth the entire understanding between Participant and the Company regarding the Award and supersede all prior oral and written agreements on that subject.
The Participant may designate receipt and acceptance of the Award and the terms of the Award Documents via electronic confirmation in accordance with instructions that accompany an electronic delivery of this Award Grant Notice by the Company to Participant.
ATTACHMENTS: | Performance Share Award Agreement and Amended and Restated 2004 Equity Incentive Award Plan |
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MEDIVATION, INC.
AMENDED AND RESTATED 2004 EQUITY INCENTIVE AWARD PLAN
PERFORMANCE SHARE AWARD AGREEMENT
Pursuant to the Performance Share Award Grant Notice (the Grant Notice) and this Performance Share Award Agreement (the Agreement), Medivation, Inc. (the Company) has awarded you, pursuant to its Amended and Restated 2004 Equity Incentive Award Plan (the Plan), the Award as indicated in the Grant Notice. This Agreement shall be deemed to be agreed to by the Company and you upon your electronic acceptance of the Award. Unless otherwise defined herein or in the Grant Notice, capitalized terms shall have the meanings set forth in the Grant Notice or Plan, as applicable.
The details of your Award are as follows.
1. DEFINITIONS
(a) Actual Award means the number of shares of Stock credited to the Participant based on achievement of applicable Performance Goals during the Performance Period.
(b) Cause means, as determined by the Board good faith, Employee has:
(1) | failed to perform his or her stated duties in all material respects, which failure continues for fifteen (15) days after Employees receipt of written notice of the failure from the Company; |
(2) | intentionally and materially breached any provision of any written agreement with the Company, and has not cured such breach within fifteen (15) days after Employees receipt of written notice of the breach from the Company (provided that, the Companys written notice is not required if Employees breach is not reasonably capable of cure); |
(3) | demonstrated Employees personal dishonesty in connection with his or her employment with the Company; |
(4) | engaged in willful misconduct in connection with his or her employment with the Company; |
(5) | engaged in a breach of fiduciary duty in connection with his or her employment with the Company; or |
(6) | willfully violated any material law, rule or regulation, or final cease-and-desist order (other than minor traffic violations or similar offenses), been convicted or pled guilty (including a no contest plea) to any felony, or engaged in other serious misconduct of such a nature that Employees continued employment may reasonably be expected to cause the Company substantial economic or reputational injury. |
(c) Certification Date means the date on which the Committee certifies whether the Performance Goals have been met during the Performance Period under this Agreement.
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(d) Maximum Award means the maximum number of shares of Stock that may be credited to the Participant if the applicable Performance Goals are achieved at the specified levels set by the Committee during the applicable Performance Period as set forth in the Grant Notice.
(e) Performance Goals means, for a Performance Period, the one or more goals established by the Committee as set forth on EXHIBIT A hereto.
(f) Performance Period means the period of time selected by the Committee over which the attainment of one or more Performance Goals will be measured for the purpose of determining the Participants right to an Actual Award as set forth on EXHIBIT A hereto.
(g) Target Award means the number of shares of Stock that may be credited to the Participant if the Performance Golas are achieved at the target levels set by the Committee during the applicable Performance Period as set forth in the Grant Notice.
(h) Termination of Service means the time when the service relationship (whether as an Employee or a consultant) between the Participant and the Company or any Subsidiary is terminated for any reason, with or without Cause, including, but not by way of limitation, a termination by resignation, discharge, death or Disability; but excluding (a) a termination where there is a simultaneous reemployment or continuing employment or consultancy of the Participant by the Company or any Subsidiary or a parent corporation thereof (within the meaning of Section 422 of the Code), (b) at the discretion of the Committee, a termination which results in a temporary severance of the employee-employer relationship, and (c) at the discretion of the Committee, a termination which is followed by the simultaneous establishment of a consulting relationship by the Company or a Subsidiary with the former Employee. The Committee, in its absolute discretion, shall determine the effect of all matters and questions relating to Termination of Service for the purposes of this Agreement, including, but not by way of limitation, the question of whether, for Participants who are Employees of the Company or any of its Subsidiaries, a Termination of Service resulted from a discharge for Cause, and all questions of whether particular leaves of absence for Participants who are Employees of the Company or any of its Subsidiaries constitute Terminations of Service. Notwithstanding any other provision of the Plan or this Agreement, the Company or any Subsidiary has an absolute and unrestricted right to terminate the Participants employment and/or consultancy at any time for any reason whatsoever, with or without Cause, except to the extent expressly provided otherwise in a written agreement between the Company and the Participant.
2. ENTITLEMENT TO SHARES. Provided that (i) the specified level of applicable Performance Goals is achieved during the Performance Period and (ii) you have not experienced a Termination of Service prior to the Certification Date, then, subject to the limitations contained herein and the provisions of the Plan, you shall be credited with an Actual Award on the Certification Date equal to all or a portion (including none) of the Target Award or the Maximum Award (in the event of performance exceeding that of the Target Award, as indicated herein), as determined by the Committee based on the degree of achievement of the Performance Goals; provided, however, that (x) if a specified level of Performance Goals is not achieved during the Performance Period, you will not be credited with or receive any shares of Stock as an Actual Award, and (y) the maximum number of shares of Stock for which you may be credited as an Actual Award will in no event exceed the Maximum Award.
3. DIVIDENDS. Prior to your receipt of any shares of Stock as under an Award, you shall not receive any payment or other adjustment in the number of shares subject to your Award for dividends or other distributions that may be made in respect of the shares of Stock to which your Award relates.
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4. DELIVERY OF SHARES. Provided that you become entitled to receive an Actual Award in accordance with Section 2 of this Agreement, the Company shall issue and deliver to you (or, in the case of death, to your beneficiary designated pursuant to Section 8 of this Agreement or your estate as beneficiary, in the absence of such a designation) the certificates representing the shares of Stock subject to an Actual Award (the Certificates). The Certificates, when issued, shall be registered in your name (or the name of your beneficiary, in the case of death) and, subject to Section 11 of this Agreement, will be delivered within thirty (30) days following the Certification Date. However, in the event that the Company determines that you are subject to its policy regarding insider trading of Stock and any shares are scheduled to be delivered to you on a day (the Original Distribution Date) that does not occur during an open window period applicable to you, as determined by the Company in accordance with such policy, then the Certificates covering such shares shall not be delivered on such Original Distribution Date and shall instead be delivered as soon as practicable within the next open window period applicable to you pursuant to such policy, but in no event later than the March 15 following the calendar year in which the Certification Date occurs. The form of delivery (e.g., a stock certificate or electronic entry evidencing such shares) shall be determined by the Company.
5. NUMBER OF SHARES. The number of shares of Stock subject to your Award will be adjusted from time to time for capitalization adjustments, as provided in Article 11 of the Plan.
6. SECURITIES LAW COMPLIANCE. The grant of your Award and the issuance of any shares of Stock pursuant to an Actual Award shall be subject to compliance with all applicable requirements of federal, state or foreign law with respect to such securities. You may not be issued any shares of Stock pursuant to an Actual Award if the issuance of shares of Stock would constitute a violation of any applicable federal, state or foreign securities laws or other law or regulations or the requirements of any stock exchange or market system upon which the Stock may then be listed. In addition, you may not be issued any shares of Stock pursuant to an Actual Award unless (i) a registration statement under the Securities Act shall at the time of issuance be in effect with respect to the shares of Stock or (ii) in the opinion of legal counsel to the Company, the shares of Stock may be issued in accordance with the terms of an applicable exemption from the registration requirements of the Securities Act. YOU ARE CAUTIONED THAT THE SHARES OF STOCK MAY NOT BE ISSUED UNLESS THE FOREGOING CONDITIONS ARE SATISFIED. The inability of the Company to obtain from any regulatory body having jurisdiction the authority, if any, deemed by the Companys legal counsel to be necessary to the lawful issuance and sale of any shares of Stock pursuant to an Actual Award shall relieve the Company of any liability in respect of the failure to issue or sell such shares as to which such requisite authority shall not have been obtained. As a condition to the issuance of any shares of Stock pursuant to an Actual Award, the Company may require you to satisfy any qualifications that may be necessary or appropriate, to evidence compliance with any applicable law or regulation and to make any representation or warranty with respect thereto as may be requested by the Company.
7. RESTRICTIVE LEGENDS. The shares of Stock issued pursuant to an Actual Award shall be endorsed with appropriate legends, if any, determined by the Company.
8. TRANSFERABILITY. Your Award is not transferable except by will or by the laws of descent and distribution. Notwithstanding the foregoing, by delivering written notice to the Company, in a form satisfactory to the Company, you may designate a third party who, in the event of your death, shall thereafter be entitled to receive any distribution of shares of Stock pursuant to Section 4 of this Agreement.
9. AWARD NOT A SERVICE CONTRACT. Your Award is not an employment or service contract, and nothing in your Award shall be deemed to create in any way whatsoever any obligation on your part to continue in the employ of the Company or any Subsidiary, or of the Company or any
4
Subsidiary to continue your employment. In addition, nothing in your Award shall obligate the Company or any Subsidiary, their respective stockholders, Boards of Directors, Officers or Employees to continue any relationship that you might have as a Director or consultant for the Company or any Subsidiary.
10. UNSECURED OBLIGATION. Your Award is unfunded, and you shall be considered an unsecured creditor of the Company with respect to the Companys obligation, if any, to issue shares of Stock pursuant to an Actual Award under this Award Agreement. You shall not have voting or any other rights as a stockholder of the Company with respect to the Stock acquired pursuant to this Award Agreement until such Stock is issued to you pursuant to this Agreement. Upon such issuance, you will obtain full voting and other rights as a stockholder of the Company with respect to the Stock so issued. Nothing contained in this Agreement, and no action taken pursuant to its provisions, shall create or be construed to create a trust of any kind or a fiduciary relationship between you and the Company or any other person.
11. WITHHOLDING OBLIGATIONS. Regardless of any action taken by the Company or any Subsidiary with respect to any or all income, employment, social insurance, or payroll taxes, payment on account or other tax-related withholding (Tax-Related Items), you acknowledge that the ultimate liability for all Tax-Related Items legally due by you is and remains your responsibility and that the Company and any Subsidiaries (i) make no representations or undertakings regarding the treatment of any Tax-Related Items in connection with any aspect of your Award, the subsequent sale of shares of Stock acquired pursuant to an Actual Award, or the receipt of any dividends and (ii) do not commit to structure the terms of the grant or any other aspect of your Award to reduce or eliminate your liability for Tax-Related Items. At the time any Actual Award is determined, at the time you receive a distribution of shares of Stock pursuant to such Actual Award, or at any other time reasonably as requested by the Company or any Subsidiary, you shall pay or make adequate arrangements satisfactory to the the Company and/or any Subsidiary to satisfy all withholding obligations of the Company or Subsidiary. In this regard, at the time you receive a distribution of shares of Stock pursuant to an Actual Award, or at any other time as reasonably requested by the Company or any Subsidiary, you hereby authorize the withholding of that number of whole shares of Stock otherwise deliverable to you pursuant to an Actual Award under this Award Agreement having a fair market value not in excess of the amount of the Tax-Related Items determined by the applicable minimum statutory rates. Finally, you shall pay to the Company or Subsidiary (as applicable) any amount of the Tax-Related Items that the Company or any Subsidiary may be required to withhold as a result of your participation in the Plan that cannot be satisfied by the means previously described. The Company and Subsidiaries shall have no obligation to deliver shares of Stock until you have satisfied the obligations in connection with the Tax-Related Items as described in this section.
12. NATURE OF AWARD. In accepting your Award, you acknowledge that:
(a) the Plan is established voluntarily by the Company; it is discretionary in nature and it may be modified, amended, suspended or terminated by the Company at any time, unless otherwise provided in the Plan and this Agreement;
(b) the grant of your Award is voluntary and occasional and does not create any contractual or other right to receive future grants of Awards, or benefits in lieu of Awards, even if Awards have been granted repeatedly in the past;
(c) all decisions with respect to future Awards under the Plan, if any, will be at the sole discretion of the Committee;
5
(d) your participation in the Plan shall not create a right to further employment with the Company or any Subsidiary and shall not interfere with any ability of the Company or any Subsidiary to terminate your employment relationship at any time with or without cause;
(e) you are voluntarily participating in the Plan;
(f) an Award is not part of normal or expected compensation or salary for any purpose, including, but not limited to, calculating any severance, resignation, termination, redundancy, end-of-service payments, bonuses, long-service awards, pension or retirement benefits or similar payments;
(g) in the event that you are not an employee of the Company, your Award will not be interpreted to form an employment contract or relationship with the Company; and furthermore, your Award will not be interpreted to form an employment contract with any Subsidiary;
(h) the future value of the shares of Stock subject to your Award is unknown and cannot be predicted with certainty; and
(i) no claim or entitlement to compensation or damages arises from termination of your Award or diminution in value of your Award or shares of Stock issued pursuant to an Actual Award resulting from a Termination of Service with the Company or any Subsidiary (for any reason whether or not in breach of applicable labor laws), and you irrevocably release the Company and Subsidiaries from any such claim that may arise. If, notwithstanding the foregoing, any such claim is found by a court of competent jurisdiction to have arisen then, by executing the Grant Notice, you shall be deemed irrevocably to have waived your entitlement to pursue such a claim.
13. DELIVERY OF DOCUMENTS AND NOTICES. Any document relating to participating in the Plan and/or notice required or permitted hereunder shall be given in writing and shall be deemed effectively given (except to the extent that this Agreement provides for effectiveness only upon actual receipt of such notice) upon personal delivery, electronic delivery, or upon deposit in the U.S. Post Office or foreign postal service, by registered or certified mail, with postage and fees prepaid, addressed to the other party at the e-mail address, if any, provided for you by the Company or a Subsidiary or at such other address as such party may designate in writing from time to time to the other party.
(a) Description of Electronic Delivery. The Plan documents, which may include but do not necessarily include the Plan prospectus, Grant Notice, Agreement, Certificates and U.S. financial reports of the Company, may be delivered to you electronically. Such means of delivery may include but do not necessarily include the delivery of a link to a Company intranet or the internet site of a third party involved in administering the Plan, the delivery of the document via e-mail or such other delivery determined at the Committees discretion.
(b) Consent to Electronic Delivery. You acknowledge that you have read Section 14 of this Agreement and consent to the electronic delivery of the Plan documents, as described in Section 14 of this Agreement. You acknowledge that you may receive from the Company a paper copy of any documents delivered electronically at no cost if you contact the Company by telephone, through a postal service or electronic mail at [ ]. You further acknowledge that you will be provided with a paper copy of any documents delivered electronically if electronic delivery fails; similarly, you understand that you must provide the Company or any designated third party with a paper copy of any documents delivered electronically if electronic delivery fails. Also, you understand that your consent may be revoked or changed, including any change in the electronic mail address to which documents are delivered (if you have provided an electronic mail address), at any time by notifying the Company of such revised or revoked consent by telephone, postal service or electronic mail at [ ]. Finally, you understand that you are not required to consent to electronic delivery.
6
14. DATA PRIVACY CONSENT. You hereby explicitly and unambiguously consent to the collection, use and transfer, in electronic or other form, of your personal data as described in this document by and among the Company and its Subsidiaries for the exclusive purpose of implementing, administering and managing your participation in the Plan.
You understand that the Company and its Subsidiaries hold certain personal information about you, including, but not limited to, your name, home address and telephone number, date of birth, social insurance number or other identification number, salary, nationality, job title, any shares of Stock or directorships held in the Company, details of all Awards or any other entitlement to shares of Stock awarded, canceled, exercised, vested, unvested or outstanding in your favor, for the purpose of implementing, administering and managing the Plan (Data). You understand that Data may be transferred to any third parties assisting in the implementation, administration and management of the Plan, that these recipients may be located in your country or elsewhere, and that the recipients country may have different data privacy laws and protections than your country. You understand that you may request a list with the names and addresses of any potential recipients of the Data by contacting your local human resources representative. You authorize the recipients to receive, possess, use, retain and transfer the Data, in electronic or other form, for the purposes of implementing, administering and managing your participation in the Plan, including any requisite transfer of such Data as may be required to a broker or other third party with whom you may elect to deposit any shares of Stock pursuant to an Actual Award. You understand that Data will be held only as long as is necessary to implement, administer and manage your participation in the Plan. You understand that you may, at any time, view Data, request additional information about the storage and processing of Data, require any necessary amendments to Data or refuse or withdraw the consents herein, in any case without cost, by contacting in writing your local human resources representative. You understand, however, that refusing or withdrawing your consent may affect your ability to participate in the Plan. For more information on the consequences of your refusal to consent or withdrawal of consent, you understand that you may contact your local human resources representative.
15. HEADINGS. The headings of the Sections in this Agreement are inserted for convenience only and shall not be deemed to constitute a part of this Agreement or to affect the meaning of this Award Agreement.
16. AMENDMENT. The Committee may, without notice, amend, suspend or terminate the Award; provided, however, that no such action may adversely affect the Award unless (i) expressly provided by the Committee and (ii) with the consent of you, unless such action is necessary to comply with any applicable law, regulation or rule.
17. MISCELLANEOUS.
(a) The rights and obligations of the Company under your Award shall be transferable to any one or more persons or entities, and all covenants and agreements hereunder shall inure to the benefit of, and be enforceable by the Companys successors and assigns.
(b) You agree upon request to execute any further documents or instruments necessary or desirable in the sole determination of the Company to carry out the purposes or intent of your Award.
7
(c) You acknowledge and agree that you have reviewed your Award in its entirety, have had an opportunity to obtain the advice of counsel prior to executing and accepting your Award and fully understand all provisions of your Award.
18. GOVERNING PLAN DOCUMENT. Your Award is subject to all the provisions of the Plan, the provisions of which are hereby made a part of your Award, and is further subject to all interpretations, amendments, rules and regulations which may from time to time be promulgated and adopted pursuant to the Plan. In the event of any conflict between the provisions of your Award and those of the Plan, the provisions of the Plan shall control.
8
EXHIBIT A
PERFORMANCE GOALS AND PERFORMANCE PERIOD
9
Exhibit 21.1
Subsidiaries of Medivation, Inc.
1. | Medivation Neurology, Inc. (Delaware) |
2. | Medivation Prostate Therapeutics, Inc. (Delaware) |
3. | Medivation Technologies, Inc. (Delaware) |
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (Nos. 333-132983 and 333-157051) of Medivation, Inc. of our report dated February 29, 2012 relating to the consolidated financial statements and the effectiveness of internal control over financial reporting, which appears in this Form 10-K.
/s/ PricewaterhouseCoopers LLP
PricewaterhouseCoopers LLP
San Jose, California
February 29, 2012
Exhibit 31.1
CERTIFICATIONS
I, David T. Hung, M.D., certify that:
1. I have reviewed this Annual Report on Form 10-K of Medivation, 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 registrants other certifying officer(s) 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;
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;
c) Evaluated the effectiveness of the registrants 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 registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an Annual Report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent 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 registrants 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 registrants internal control over financial reporting.
Date: February 29, 2012
/s/ David T. Hung |
David T. Hung, M.D. |
President and Chief Executive Officer |
Exhibit 31.2
CERTIFICATIONS
I, C. Patrick Machado, certify that:
1. I have reviewed this Annual Report on Form 10-K of Medivation, 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 registrants other certifying officer(s) 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;
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;
c) Evaluated the effectiveness of the registrants 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 registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an Annual Report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent 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 registrants 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 registrants internal control over financial reporting.
Date: February 29, 2012
/s/ C. Patrick Machado |
C. Patrick Machado |
Chief Business Officer and Chief Financial Officer |
Exhibit 32.1
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the Exchange Act), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), David T. Hung, M.D., President and Chief Executive Officer of Medivation, Inc. (the Company), and C. Patrick Machado, Chief Business Officer and Chief Financial Officer of the Company, each hereby certifies that, to the best of his or her knowledge:
1. The Companys Annual Report on Form 10-K for the period ended December 31, 2011, to which this Certification is attached as Exhibit 32.1 (the Annual Report) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, as amended; and
2. The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
In Witness Whereof, the undersigned have set their hands hereto as of the 29th day of February, 2012.
/s/ David T. Hung |
/s/ C. Patrick Machado | |||
David T. Hung, M.D. | C. Patrick Machado | |||
President and Chief Executive Officer | Chief Business Officer and Chief Financial Officer |
This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Medivation, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.
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