Form 10-Q

-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, OTY74g24NepWpm+JO79hNT6HIEADoefWYrQM6QMj8o95+h34eQJjxazJraFHfqu2 D31/SEKyE3NCui0wEkKkNw== 0001193125-08-231723.txt : 20081110 0001193125-08-231723.hdr.sgml : 20081110 20081110161349 ACCESSION NUMBER: 0001193125-08-231723 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20080930 FILED AS OF DATE: 20081110 DATE AS OF CHANGE: 20081110 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDIVATION, INC. CENTRAL INDEX KEY: 0001011835 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133863260 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-32836 FILM NUMBER: 081175800 BUSINESS ADDRESS: STREET 1: 201 SPEAR STREET, 3RD FLOOR CITY: SAN FRANCISCO STATE: CA ZIP: 94105 BUSINESS PHONE: 415-543-3470 MAIL ADDRESS: STREET 1: 201 SPEAR STREET, 3RD FLOOR CITY: SAN FRANCISCO STATE: CA ZIP: 94105 FORMER COMPANY: FORMER CONFORMED NAME: ORION ACQUISITION CORP II DATE OF NAME CHANGE: 19960408 10-Q 1 d10q.htm FORM 10-Q Form 10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended September 30, 2008

¨	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)		(IRS Employer Identification No.)

201 Spear Street, 3rd floor

San Francisco, California 94105

(Address of principal executive offices) (Zip Code)

(415) 543-3470

(Registrant’s telephone number, including area code)

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 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 ¨	Accelerated filer x	Non-accelerated filer ¨	Smaller reporting company ¨
		(Do not check if a smaller reporting company)

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

As of November 7, 2008, 30,079,390 shares of the registrant’s Common Stock, $0.01 par value per share, were issued and outstanding.

Table of Contents

MEDIVATION, INC.

Form 10-Q

Table of Contents


		Page No.
PART I. Financial Information		3

Item 1.	Financial Statements (unaudited):	3

	Condensed Consolidated Balance Sheets	3

	Condensed Consolidated Statements of Operations	4

	Condensed Consolidated Statements of Cash Flows	5

	Notes to Condensed Consolidated Financial Statements	6

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	11

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	16

Item 4.	Controls and Procedures	17

PART II. Other Information		17

Item 1.	Legal Proceedings	17

Item 1A.	Risk Factors	17

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	25

Item 3.	Defaults Upon Senior Securities	25

Item 4.	Submission of Matters to a Vote of Security Holders	26

Item 5.	Other Information	26

Item 6.	Exhibits	26

Signatures		27

Exhibits		28

PART I — FINANCIAL INFORMATION

ITEM 1.

FINANCIAL STATEMENTS.

MEDIVATION, INC.

(A DEVELOPMENT STAGE COMPANY)

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)


	(unaudited) September 30, 2008			December 31, 2007 (1)
ASSETS
Current assets:
Cash and cash equivalents	$	20,374		$	43,258
Prepaid expenses and other current assets		1,683			991

Total current assets		22,057			44,249

Property and equipment, net		728			689
Intellectual property, net		55			58
Other non-current assets		1,195			600

Total assets	$	24,035		$	45,596

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	6,203		$	1,747
Accrued expenses		8,793			2,218
Other current liabilities		87			70

Total current liabilities		15,083			4,035

Other non-current liabilities		426			492
Series A redeemable preferred stock		11			11

Total liabilities		15,520			4,538


Commitments and contingencies (Note 7)

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; 30,079,390 shares issued and outstanding at September 30, 2008 and 28,837,290 issued and outstanding at December 31, 2007		301			288
Additional paid-in capital		122,943			100,970
Deficit accumulated during the development stage		(114,729	)		(60,200	)

Total stockholders’ equity		8,515			41,058

Total liabilities and stockholders’ equity	$	24,035		$	45,596

(1)	The balance sheet data at December 31, 2007 is derived from audited financial statements included in the Company’s Annual Report on form 10-KSB for the year ended December 31, 2007 filed with the Securities Exchange Commission.

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

MEDIVATION, INC.

(A DEVELOPMENT STAGE COMPANY)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)


	Three Months Ended September 30,						Nine Months Ended September 30,						Period from Inception (September 4, 2003) to September 30, 2008
	2008			2007			2008			2007
Operating expenses:
Research and development	$	15,514		$	6,797		$	41,728		$	16,306		$	84,067
General and administrative		5,122			3,026			13,532			7,383			32,694

Total operating expenses		20,636			9,823			55,260			23,689			116,761
Loss from operations		(20,636	)		(9,823	)		(55,260	)		(23,689	)		(116,761	)

Interest and other income (expense):
Interest income, net		170			460			735			1,522			3,674
Other income (expense), net		10			-			(4	)		(3	)		(1,642	)

Total other income (expense)		180			460			731			1,519			2,032

Net loss	$	(20,456	)	$	(9,363	)	$	(54,529	)	$	(22,170	)	$	(114,729	)

Basic and diluted net loss per share	$	(0.68	)	$	(0.34	)	$	(1.86	)	$	(0.80	)

Weighted average common shares used in the calculation of basic and diluted net loss per share		30,022			27,797			29,273			27,776

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

MEDIVATION, INC.

(A DEVELOPMENT STAGE COMPANY)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)


	Nine months ended September 30,						Period from Inception (September 4, 2003) to September 30, 2008
	2008			2007
Cash flows from operating activities:
Net loss	$	(54,529	)	$	(22,170	)	$	(114,729	)
Adjustments to reconcile net loss to net cash used in operating activities:
Impairment of intellectual property		—			—			143
Depreciation and amortization		139			36			235
Loss on disposal of property and equipment		—			6			6
Accretion of discount on securities		—			(69	)		(79	)
Stock-based compensation		6,444			4,272			16,009
Warrants issued to related party guarantors		—			—			18
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(692	)		128			(1,683	)
Other non-current assets		(595	)		(488	)		(1,195	)
Accounts payable		4,456			2,390			6,203
Accrued expenses		6,575			670			8,793
Other current liabilities		17			—			87
Other non-current liabilities		(66	)		504			426

Net cash used in operating activities		(38,251	)		(14,721	)		(85,766	)

Cash flows from investing activities:
Medivation cash balances at closing of December 2004 merger		—			—			1,933
Purchase of short-term investments		—			—			(101,527	)
Maturities of short-term investments		—			42,264			101,606
Purchase of property and equipment		(175	)		(699	)		(942	)
Purchase of intellectual property		—			—			(225	)

Net cash provided by (used in) investing activities		(175	)		41,565			845

Cash flows from financing activities:
Issuance of Series B preferred stock		—			—			2
Issuance of convertible notes:
To related party		—			—			1,250
To other party		—			—			600
Principal repayment on notes held by related party		—			—			(596	)
Issuance of common stock		15,000			—			107,653
Offering costs paid in cash		(84	)		(196	)		(4,723	)
Class B warrant exercises		—			—			25
Stock option exercises		626			204			1,084

Net cash provided by financing activities		15,542			8			105,295

Net increase (decrease) in cash and cash equivalents		(22,884	)		26,852			20,374
Cash and cash equivalents at beginning of period		43,258			4,649			—

Cash and cash equivalents at end of period	$	20,374		$	31,501		$	20,374

Supplemental schedule of non-cash investing and financing activities:
Shares issued for conversion of convertible notes (including accrued interest):
To related party		—			—			689
To other party		—			—			611
Shares issued for placement agent services in the December 2004 financing		—			—			970
Warrants issued for placement agent services in the December 2004 financing		—			—			633

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

MEDIVATION, INC.

(A DEVELOPMENT STAGE COMPANY)

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2008

(Unaudited)

NOTE 1 — THE COMPANY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The Company

Medivation, Inc., or the Company, together with its operating subsidiaries, is a biopharmaceutical company with small molecule drugs in clinical development to treat three large, unmet medical needs—Alzheimer’s disease, Huntington’s disease and castration-resistant (also known as hormone-refractory) prostate cancer. To date, the Company’s operations have been directed primarily toward developing proprietary product candidates. Accordingly, the Company is considered to be in the development stage. The Company has not generated any revenue from operations to date and does not expect to generate any product revenue for several years, if ever.

The Company has incurred cumulative net losses of $114.7 million through September 30, 2008, and expects to incur substantial and increasing additional losses in the future as it expands its research and development activities. At September 30, 2008, the Company had cash and cash equivalents of $20.4 million and remaining capacity under its committed equity line of credit with Azimuth Opportunity, Ltd., or Azimuth, of $78.8 million. The Company obtained its equity line of credit from Azimuth pursuant to a Common Stock Purchase Agreement dated September 7, 2007. Subject to the conditions set forth in that agreement, Azimuth is committed to purchase up to $100 million of the Company’s common stock pursuant to draw down notices that the Company may give to Azimuth from time to time at the Company’s discretion until April 1, 2009. The price of shares sold is determined by reference to the volume weighted average price of the Company’s common stock on the Nasdaq Global Market during a ten trading day pricing period at the time of each draw down notice, less a discount of 4.65 to 6.15 percent. On September 3, 2008, the Company announced that it had entered into a Collaboration Agreement with Pfizer Inc., or Pfizer, which became effective on October 21, 2008. Under the terms of the agreement, the Company and Pfizer will develop and commercialize Dimebon, the Company’s investigational drug for treatment of Alzheimer’s disease and Huntington’s disease. On October 27, 2008, the Company received an up-front cash payment of $225 million from Pfizer pursuant to the Collaboration Agreement. The Company also is eligible to receive payments of up to $500 million upon the attainment of development and regulatory milestones plus additional milestone payments upon the achievement of certain net sales levels for the product. The Company and Pfizer will share the costs and expenses of developing and commercializing Dimebon for the United States market on a 60% Pfizer/40% Company basis, and will share profits (or losses) resulting from commercialization of Dimebon in the United States in the same proportions. Outside the United States, Pfizer will bear all development and commercialization costs, and will pay the Company tiered royalties on aggregate net sales of Dimebon. Based upon the Company’s current expectations, management believes the Company’s existing capital resources, including the $225 million up-front cash payment from Pfizer will be sufficient to fund its currently planned operations beyond 2009.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the U.S. for complete financial statements. The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of management, all adjustments, consisting of normal recurring adjustments necessary for the fair statement of results for the periods presented, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period.

The preparation of unaudited condensed consolidated financial statements requires management to make estimates and assumptions that affect the recorded amounts reported therein. A change in facts or circumstances surrounding the estimate could result in a change to estimates and impact future operating results.

The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the interim unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the fiscal year ended December 31, 2007 included in the Company’s annual report on Form 10-KSB filed with the Securities and Exchange Commission, or the Commission, on February 19, 2008.

The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Medivation Neurology, Inc. and Medivation Prostate Therapeutics, Inc., and reflect the elimination of intercompany accounts and transactions. The Company acquired its operating subsidiary Medivation Neurology, Inc. by merger on December 17, 2004. Because the merger was accounted for as a reverse merger under generally accepted accounting principles, the consolidated financial statements of the Company for periods prior to that date reflect only the operations of Medivation Neurology, Inc.

In the second quarter of 2008, the Company revised the classification of patent-related legal costs from research and development expense to general and administrative expense, as such costs typically would be excluded from research and development costs as defined by Statement of Financial Accounting Standards No. 2, Accounting for Research and Development Costs. Amounts related to prior periods are not considered material to the financial statements taken as a whole, but were revised for purposes of comparability. Such amounts for the nine-month period ended September 30, 2008, the three- and nine-month periods ended September 30, 2007, and the cumulative period from inception (September 4, 2003) to September 30, 2008 were $357,000, $388,000, $806,000, and $2,668,510, respectively. The revision did not affect previously reported total operating expenses, net loss, earnings per share, assets, liabilities, stockholders’ equity or cash flows.

Recently Issued Accounting Pronouncements

In October 2008, the Financial Accounting Standards Board, or FASB, issued FASB Staff Position, or FSP, FAS 157-3, Determining the Fair Value of a Financial Asset When the Market for that Asset is not Active, or FSP 157-3. FSP 157-3 clarified the application of FAS 157. FSP 157-3 demonstrated how the fair value of a financial asset is determined when the market for that financial asset is inactive. FSP 157-3 was effective upon issuance, including prior periods for which financial statements had not been issued. The implementation of this standard did not have an impact on our consolidated financial statements.

In June 2008, the FASB ratified EITF Issue 07-5, Determining Whether an Instrument (or Embedded Feature) is Indexed to an Entity’s Own Stock, effective for us as of January 1, 2009. This standard establishes criteria for determining whether freestanding instruments or embedded features are considered “indexed to an entity’s own stock.” This guidance must be applied in assessing the equity conversion features in our outstanding warrants. These conversion features have been exempted from derivative accounting because they are indexed to our own stock and would be classified in stockholders’ equity. We will have to assess whether they are still considered indexed to our own stock under this new guidance. The standard applies to all outstanding instruments at January 1, 2009, with any transition impacts recognized as a cumulative effect adjustment to the opening balance of retained earnings. We are evaluating the impact, if any, this standard will have on our consolidated financial statements.

In June 2008, the FASB issued FSP EITF 03-6-1, Determining Whether Instruments Granted in Share-Based Transactions Are Participating Securities. This standard provides guidance in determining whether unvested instruments granted under share-based payment transactions are participating securities and, therefore, should be included in earnings per share calculations under the two-class method provided under Statement of Financial Accounting Standards, or SFAS, No. 128, Earnings per Share. FSP EITF 03-6-1 is effective for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years. The Company does not expect that the adoption of FSP EITF 03-6-1 will have a significant impact on its condensed consolidated financial statements.

In April 2008, the FASB issued FSP FAS 142-3, Determination of the Useful Life of Intangible Assets. FSP FAS 142-3 amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under SFAS No. 142, Goodwill and Other Intangible Assets. FSP FAS 142-3 aims to improve the consistency between the useful life of a recognized intangible asset under SFAS No. 142 and the period of expected cash flows used to measure the fair value of the asset under SFAS No. 141(R) and other applicable accounting literature. FSP FAS 142-3 is effective for financial statements issued for fiscal years beginning after December 15, 2008 and must be applied prospectively to intangible assets acquired after the effective date. The Company does not expect that the adoption of FSP FAS 142-3 will have a significant impact on its condensed consolidated financial statements.

In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging Activities—an amendment of FASB Statement No. 133 . This Statement is intended to enhance the current disclosure framework in Statement No. 133. The Statement requires that objectives for using derivative instruments be disclosed in terms of underlying risk and accounting designation. This disclosure better conveys the purpose of derivative use in terms of the risks that the entity is intending to manage. Disclosing the fair values of derivative instruments and their gains and losses in a tabular format should provide a more complete picture of the location in an entity’s financial statements of both the derivative positions existing at period end and the effect of using derivatives during the reporting period. Disclosing information about credit-risk-related contingent features should provide information on the potential effect on an entity’s liquidity from using derivatives. Finally, this Statement requires cross-referencing within the footnotes, which should help users of financial statements locate important information about derivative instruments. The Company does not expect that the adoption of SFAS No. 161 will have a significant impact on the consolidated results of operations or financial position of the Company.

In February 2008, the FASB issued FASB Staff Position FAS 157-2, Effective Date of FASB Statement No. 157, which deferred the effective date of SFAS No. 157 for one year, effective for fiscal years beginning after November 15, 2008, as it relates to non-financial assets and liabilities. The Company does not expect that the adoption of FAS 157-2 will have a significant impact on the consolidated results of operations or financial position of the Company.

No. 141R is effective for business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. The Company does not expect that the adoption of SFAS No. 141R will have a significant impact on the consolidated results of operations or financial position of the Company.

In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial Statements—an Amendment of Accounting Research Bulletin No. 51, which establishes accounting and reporting standards for ownership interests in subsidiaries held by parties other than the parent, the amount of consolidated net income attributable to the parent and to the noncontrolling interest, changes in a parent’s ownership interest and the valuation of retained noncontrolling equity investments when a subsidiary is deconsolidated. SFAS No. 160 also establishes reporting requirements that provide sufficient disclosures that clearly identify and distinguish between the interests of the parent and the interests of the noncontrolling owners. SFAS No. 160 is effective for fiscal years, and interim periods within those fiscal years, beginning on or after December 15, 2008. The Company does not expect that the adoption of SFAS No. 160 will have a significant impact on the consolidated results of operations or financial position of the Company.

NOTE 2 — BASIC AND DILUTED NET LOSS PER SHARE

Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed similarly to basic net loss per share, except that the denominator is increased to include all dilutive potential common shares, including outstanding options, warrants and common stock subject to repurchase. Potentially dilutive common shares have been excluded from the diluted loss per common share computations in all periods presented because such securities have an anti-dilutive effect on loss per common share due to the Company’s net loss. At September 30, 2008 and 2007 these potentially dilutive securities were as follows (in thousands):

Loss per Common Shares


	At September 30,
	2008	2007
Outstanding options	4,164	2,734
Outstanding warrants	316	322
Outstanding restricted shares	30	—

Total	4,510	3,056

NOTE 3 — STOCK-BASED COMPENSATION

2004 Equity Incentive Plan

The Company’s Amended and Restated 2004 Equity Incentive Award Plan, or the Plan, which is stockholder-approved, provides for the issuance of options and other stock-based awards, including restricted stock and stock appreciation rights, covering up to 7,500,000 shares of the Company’s common stock. Shares issued upon exercise of stock-based awards are new shares that have been reserved for issuance under the Plan. The amendment and restatement of the Plan was approved by the Board and by the stockholders in March and May 2007, respectively.

The 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 term of stock options granted under the Plan cannot exceed ten years. Options generally have an exercise price equal to the fair market value of the common stock on the grant date and generally vest over a period of four years. The options may contain an early exercise feature, pursuant to which the optionee may exercise the option before it has vested. However, so long as an option remains unvested, all shares purchased upon early exercise remain subject to repurchase by the Company at the option exercise price if the optionee’s service with the Company terminates. For purposes of the following disclosures, early exercise options are not considered to have been exercised, or to be exercisable, until this repurchase right has lapsed. To date, the Company has not issued any shares upon early exercise of stock options. In addition, all outstanding awards under the Plan will accelerate and become immediately exercisable upon a “change of control” of the Company, as defined in the Plan.

The following table summarizes activity under the Plan during the nine-month period ended September 30, 2008.


	Number of Options	Weighted Average Exercise Price		Number of Restricted Shares
Outstanding at January 1, 2008	3,359,326	$	10.10	—
Granted	926,720	$	17.35	30,000
Exercised	107,086	$	5.86	—
Forfeited	14,700	$	21.17	—

Outstanding at September 30, 2008	4,164,260	$	11.79	30,000

Exercisable/vested at September 30, 2008	1,671,198	$	5.00	—

Stock-Based Compensation

The Company accounts for stock-based compensation pursuant to SFAS No. 123R, Share-Based Payments. The Company estimates the fair value of stock options and warrants using the Black-Scholes option valuation model. Estimated volatility is based on the historical stock price volatility of the Company’s common stock, the historical stock price volatility of comparable companies’ common stock and the implied volatility of the Company’s common stock inherent in the market prices of publicly traded options in its common stock. Estimated dividend yield is 0%. The risk-free rate is estimated to equal U.S. Treasury security rates for the applicable terms. The Company does not have sufficient history of exercise behavior to develop estimates of expected term since as of September 30, 2008 only five percent of the options it has issued since inception had been exercised. Accordingly, the Company uses the simplified method of estimating option term provided for in the Commission’s Staff Accounting Bulletins 107 and 110 for options granted to employees and directors, which results in an estimated option term of six years. For consultant options, the Company uses an estimated option term of four years, which is equal to the period required for the options to vest in full. As the Company gathers more history regarding its option exercise pattern, and as information regarding the option exercise pattern of comparable companies in its industry becomes publicly available, it will review these estimates and revise them as appropriate. Different estimates of volatility and expected term could materially change the value of an option and the resulting expense.

Stock-based awards granted to employees and directors are valued at their respective grant dates and expensed over the remaining vesting period of the award. Stock-based awards 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 future periods, the Company will revalue the associated awards and recognize additional expense based on their then-current fair values.

Total stock-based compensation recognized by the Company in the three and nine months ended September 30, 2008 and 2007 was as follows:


	Three months ended September 30,				Nine months ended September 30,
	2008		2007		2008		2007
	(in thousands)
Research and development expense	$	1,244	$	583	$	3,060	$	1,432
General and administrative expense		1,008		1,054		3,384		2,840

Total stock-based compensation expense	$	2,252	$	1,637	$	6,444	$	4,272

Unearned stock-based compensation attributable to employee and director awards totaled $19.6 million at September 30, 2008 and will be recognized as expense over a weighted-average period of 2.8 years.

NOTE 4 — ACCRUED EXPENSES

At September 30, 2008 and December 31, 2007, accrued expenses consisted of the following (in thousands):


	September 30, 2008		December 31, 2007
Payroll and payroll related	$	2,191	$	75
Preclinical and clinical trials		5,791		1,583
Other		811		560

Total accrued expenses	$	8,793	$	2,218

NOTE 5 — THIRD PARTY EQUITY INTERESTS IN OPERATING SUBSIDIARIES

(a) Medivation Neurology, Inc.

At September 30, 2008, the Company owned all of the issued and outstanding stock of its operating subsidiary Medivation Neurology, Inc., or MNI, and there were no outstanding options, warrants or any other third party rights to acquire any MNI stock.

(b) Medivation Prostate Therapeutics, Inc.

At September 30, 2008, the Company owned all of the issued and outstanding stock of its operating subsidiary Medivation Prostate Therapeutics, Inc., or MPT, and is entitled to receive one additional share for each dollar that the Company invests, directly or indirectly, in MPT. MPT has reserved an aggregate of 3,000,000 shares of its common stock for issuance upon the exercise of awards granted under the Medivation Prostate Therapeutics, Inc. Equity Incentive Plan, or the MPT Plan. At September 30, 2008, one option was outstanding under the MPT Plan. This option, which was issued to the licensor of MPT’s MDV300 series technology, is exercisable without cash payment for 150,000 shares of MPT common stock, but vests and becomes exercisable only upon the occurrence of specified MPT liquidity events including a sale of MPT, a public offering of MPT’s common stock, a corporate partnership involving MPT, or receipt of regulatory approval to market any MPT product. In accordance with Emerging Issues Task Force, or EITF, Issue No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services, no expense will be recognized with respect to this option unless and until such a liquidity event occurs.

NOTE 6 — COMMON STOCK OFFERING

In June 2008, the Company raised $15 million in a public offering of 1,129,518 shares of its Common Stock pursuant to an effective registration statement on Form S-3 previously filed with the Commission. Cash offering costs of $42,000 incurred in connection with this public offering were charged against additional paid-in capital in the three-month period ended June 30, 2008.

NOTE 7 — COMMITMENTS AND CONTINGENCIES

The Company has commitments under operating leases for its current and former offices in San Francisco, California, which leases run through August 2012 and April 2011, respectively. The future minimum lease payments under the two operating leases, net of sublease income, at September 30, 2008 are as follows (in thousands):


Years Ending December 31,
2008 (remaining three months)	$	152
2009		615
2010		635
2011		695
2012		397

Total	$	2,494

NOTE 8 — SUBSEQUENT EVENTS

On October 27, 2008, the Company received an up-front cash payment of $225 million pursuant to the Collaboration Agreement with Pfizer. These funds have been fully invested in short-term U.S. Treasury securities and in money market funds consisting solely of short-term U.S. Treasury securities.

ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

The following discussion should be read in conjunction with our audited consolidated financial statements and notes thereto for the fiscal year ended December 31, 2007, included in our Annual Report on Form 10-KSB for the year ended December 31, 2007 filed with the Commission on February 19, 2008. The following Management’s Discussion and Analysis of Financial Condition and Results of Operations contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. We intend that these forward-looking 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. The forward-looking statements contained in this Quarterly Report on Form 10-Q 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” in Item 1A of Part II below. Readers are expressly advised to review and consider those Risk Factors, which include risks associated with (1) our ability to successfully complete clinical and preclinical trials for our product candidates, (2) our ability to obtain required regulatory approvals to develop and market our product candidates, (3) our ability to raise additional capital on favorable terms, (4) our ability to execute our development plan on time and on budget, (5) our ability to obtain corporate partners, (6) our ability, whether alone or with corporate partners, to successfully commercialize any of our product candidates that may be approved for sale, and (7) our ability to identify and obtain additional product candidates. Although we believe that the assumptions underlying the forward-looking statements contained in this Quarterly Report on Form 10-Q are reasonable, any of the assumptions could be inaccurate, and therefore we cannot be certain 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. 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.

The Company

We are a biopharmaceutical company with small molecule drugs in clinical development to treat three large, unmet medical needs—Alzheimer’s disease, Huntington’s disease and castration-resistant (also known as hormone-refractory) prostate cancer. Our strategy is to identify promising product candidates, to develop them in a rapid, cost-effective manner, and to seek development and/or commercialization partners as appropriate to complement our internal efforts.

Our Pipeline

Dimebon in Alzheimer’s Disease and Huntington’s Disease

Our lead product candidate, Dimebon, has successfully completed the first of two pivotal clinical trials required to seek marketing approval from the U.S. Food and Drug Administration, or FDA, in the U.S. for mild-to-moderate Alzheimer’s disease. We began our confirmatory pivotal Phase 3 Alzheimer’s disease trial in the second quarter of 2008. Dimebon has successfully completed a Phase 1-2 clinical trial in patients with mild-to-moderate Huntington’s disease, the top-line results of which we reported in July 2008. Dimebon has been shown to inhibit the death of brain cells, or neurons, in preclinical models of Alzheimer’s disease and Huntington’s disease, making it a potential novel treatment for these and potentially other neurodegenerative diseases. Based on data generated in independent third party laboratories, we believe that Dimebon operates through a novel mitochondrial mechanism of action.

MDV3100 in Castration-Resistant Prostate Cancer

Our proprietary compound MDV3100 is currently in a Phase 1-2 clinical trial in patients with castration-resistant prostate cancer. MDV3100 is the lead clinical development candidate from a library of approximately 170 small molecules licensed by the Company. These molecules were rationally designed to treat castration-resistant prostate cancer by modulating the androgen receptor, or AR, in a different manner from currently approved AR antagonist drugs, which generally are ineffective in treating prostate cancers that have become castration-resistant.

New Product Candidates

We remain actively engaged in identifying new product candidates, both internally and externally, to further expand our pipeline of product candidates.

Results of Operations

Three Months Ended September 30, 2008 and 2007

Research and Development Expense


	Three Months Ended September 30,				Percent Change
	2008		2007		Percent Change
	(in thousands)
Research and development expense	$	15,514	$	6,797	128	%

The increase of 128% or $8.7 million in research and development expense in the three months ended September 30, 2008 as compared to the prior year period was due primarily to an increase in clinical and preclinical study expense of $7.6 million, and an increase in payroll and other indirect costs of $1.1 million. These increases were driven primarily by significant expansions in our clinical development work for both Dimebon and MDV3100, including initiation of our ongoing confirmatory Phase 3 clinical trial of Dimebon in Alzheimer’s disease and continuation of our ongoing Phase 1-2 clinical trial of MDV3100 in castration-resistant prostate cancer, and associated increases in research and development headcount to 31 at September 30, 2008 from 18 a year earlier.

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 preclinical and clinical study costs, cost of supplying drug substance and drug product for use in preclinical and clinical studies, contract research organization fees, and other contracted services pertaining to specific preclinical and clinical studies. Indirect costs consist of personnel costs (including both cash costs and non-cash stock-based compensation costs), facilities and other corporate overhead costs, and other administrative and support costs.

To date, we have been engaged in two major research and development projects: the development of Dimebon for Alzheimer’s disease and Huntington’s disease, and the development of MDV3100 for castration-resistant prostate cancer. The following table summarizes the direct costs attributable to each project and the total indirect costs for each respective period.


	Three Months Ended September 30,
	2008		2007
	(in thousands)
Direct Costs:
Dimebon	$	8,489	$	2,669
MDV 3100		2,039		615
Other		827		433

Total direct costs		11,355		3,717
Indirect costs		4,159		3,080

Total research and development expenses	$	15,514	$	6,797

General and Administrative Expense


	Three Months Ended September 30,				Percent Change
	2008		2007		Percent Change
	(in thousands)
General and administrative expense	$	5,122	$	3,026	69	%

The increase of 69% or $2.1 million in general and administrative expense in the three months ended September 30, 2008 as compared to the prior year period was due primarily to increases in payroll expense ($1.3 million), patent and other professional fees ($0.6 million), and facilities costs ($0.1 million), incurred primarily in support of our expanded research and development work. General and administrative headcount increased to 16 at September 30, 2008 from eight a year earlier.

Interest and Other Income (Expense)


	Three Months Ended September 30,				Percent Change
	2008		2007		Percent Change
	(in thousands)
Interest and other income (expense)	$	180	$	460	-61	%

The decrease of 61% or $0.3 million in interest and other income (expense) in the three months ended September 30, 2008 as compared to the prior year period was due to decreased interest income, attributable to lower average cash balances and lower prevailing interest rates.

Nine Months Ended September 30, 2008 and 2007

Research and development expenses (in thousands)


	Nine Months Ended September 30,				Percent Change
	2008		2007		Percent Change
	(in thousands)
Research and development expense	$	41,728	$	16,306	156	%

The increase of 156% or $25.4 million in research and development expense in the nine months ended September 30, 2008 as compared to the prior year period was due primarily to an increase in clinical and preclinical study expense of $21.7 million, and an increase in payroll and other indirect costs of $3.7 million. These increases were driven primarily by significant expansions in our clinical development work for both Dimebon and MDV3100, including initiation of our ongoing confirmatory Phase 3 clinical trial of Dimebon in Alzheimer’s disease and continuation of our ongoing Phase 1-2 clinical trial of MDV3100 in castration-resistant prostate cancer, and associated increases in research and development headcount to 31 at September 30, 2008 from 18 a year earlier.

The following table summarizes the direct costs attributable to each project and the total indirect costs for each respective period.


	Nine Months Ended September 30,
	2008		2007
	(in thousands)
Direct Costs:
Dimebon	$	23,140	$	6,992
MDV 3100		5,805		2,029
Other		2,374		577

Total direct costs		31,319		9,598
Indirect costs		10,409		6,708

Total research and development expenses	$	41,728	$	16,306

General and Administrative Expense


	Nine Months Ended September 30,				Percent Change
	2008		2007		Percent Change
	(in thousands)
General and administrative expense	$	13,532	$	7,383	83	%

The increase of 83% or $6.1 million in general and administrative expense in the nine months ended September 30, 2008 as compared to the prior year period was due primarily to increases in payroll expense ($3.4 million), patent and other professional fees ($1.8 million), and facilities costs ($0.4 million), incurred primarily in support of our expanded research and development work. General and administrative headcount increased to 16 at September 30, 2008 from eight a year earlier.

Interest and Other Income (Expense)


	Nine Months Ended September 30,				Percent Change
	Nine Months Ended September 30,
	2008		2007
	(in thousands)
Interest and other income (expense)	$	731	$	1,519	-52	%

The decrease of 52% or $0.8 million in interest and other income (expense) in the nine months ended September 30, 2008 as compared to the prior year period was due to decreased interest income, attributable to lower average cash balances and lower prevailing interest rates.

Liquidity and Capital Resources

We have incurred cumulative net losses of $114.7 million through September 30, 2008, and we expect to incur substantial and increasing additional losses in the future as we expand our research and development activities. We have not generated any revenue from operations to date and do not expect to generate product revenue for several years, if ever. All of our operations to date have been funded through the sale of our debt and equity securities, and the $225 million up-front payment we received from Pfizer on October 27, 2008. We had cash and cash equivalents of $20.4 million and $43.3 million as of September 30, 2008 and December 31, 2007, respectively, available to fund operations. In addition, at September 30, 2008, the remaining capacity under our committed equity line of credit with Azimuth was $78.8 million. We may draw on that remaining capacity at our discretion during the term of the facility, which expires on April 1, 2009. We obtained our equity line of credit from Azimuth pursuant to a Common Stock Purchase Agreement dated September 7, 2007. Subject to the conditions set forth in that agreement, Azimuth is committed to purchase up to $100 million of our common stock pursuant to draw down notices that we may give to Azimuth from time to time at our discretion until April 1, 2009. The price of shares sold is determined by reference to the volume weighted average price of our common stock on the Nasdaq Global Market during a ten trading day pricing period at the time of each draw down notice, less a discount of 4.65 to 6.15 percent.

On September 3, 2008, the Company announced that it had entered into a Collaboration Agreement with Pfizer Inc., or Pfizer, which became effective in October 2008. Under the terms of the agreement the Company and Pfizer will jointly develop and commercialize Dimebon, the Company’s investigational drug for the treatment of Alzheimer’s disease and Huntington’s disease. On October 27, 2008, the Company received an up-front cash payment of $225 million pursuant to the Collaboration Agreement with Pfizer. These funds have been fully invested in short-term U.S. Treasury securities and in money market funds consisting solely of short-term U.S. Treasury securities. The Company also is eligible to receive payments of up to $500 million upon the attainment of development and regulatory milestones plus additional milestone payments upon the achievement of certain net sales levels for the product. The Company and Pfizer will share the costs and expenses of developing and commercializing Dimebon for the United States market on a 60% Pfizer/40% Company basis, and will share profits (or losses) resulting from the commercialization of Dimebon in the United States in the same proportions. Outside the United States, Pfizer will bear all development and commercialization costs and will pay the Company tiered royalties on the aggregate net sales of Dimebon.

Based upon our current expectations, we believe our existing capital resources, including the $225 million up-front cash payment from Pfizer, will be sufficient to fund our currently planned operations beyond 2009.

Net cash used in operating activities for the nine months ended September 30, 2008 and 2007 was $38.3 million and $14.7 million, respectively. The increase of $23.6 million in net cash used in operations was primarily attributable to a higher net loss in 2008, partially offset by non-cash stock-based compensation expense and an increase in accounts payable, accrued expenses and other current liabilities arising in the ordinary course of business as a result of the Company’s increasing research and development activities.

Net cash used in investing activities for the nine months ended September 30, 2008 was $0.2 million, compared to net cash provided by investing activities of $41.6 million in the nine months ended September 30, 2007. The $41.8 million decrease in net cash provided by investing activities in the nine months ended September 30, 2008 compared to the prior year period was due primarily to decreases in maturities of short-term investments.

Net cash provided by financing activities for the nine months ended September 30, 2008 and 2007 was $15.6 million and $0 million, respectively. The increase was due to our sale in 2008 of 1,129,518 shares of our common stock in a registered direct offering, raising gross proceeds of approximately $15 million, and $0.6 million in proceeds from the issuance of common stock related to the exercise of employee stock options.

Critical Accounting Policies, Estimates and Judgments

This discussion and analysis of financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures. On an on-going basis, we evaluate our estimates, including those related to clinical trial accruals and stock-based compensation. We base our estimates on historical experience and on various other factors what we believe are reasonable under the circumstances. Actual results, however, may differ significantly from these estimates under different assumptions or conditions and may adversely affect the financial statements.

We believe the following critical accounting policies reflect the more significant judgments and estimates used in the preparation of our financial statements and accompanying notes.

Research and Development Expenses 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.

Stock-Based Compensation

The Company accounts for stock-based compensation pursuant to SFAS No. 123R, Share-Based Payments. The Company estimates the fair value of stock options and warrants using the Black-Scholes option valuation model. Estimated volatility is based on the historical stock price volatility of the Company’s common stock, the historical stock price volatility of comparable companies’ common stock and the implied volatility of the Company’s common stock inherent in the market prices of publicly traded options in its common stock. Estimated dividend yield is 0%. The risk-free rate is estimated to equal U.S. Treasury security rates for the applicable terms. The Company does not have sufficient history of exercise behavior to develop estimates of expected term since as of September 30, 2008 only five percent of the options it has issued since inception have been exercised. Accordingly, the Company uses the simplified method of estimating option term provided for in the Commission’s Staff Accounting Bulletins 107 and 110 for options granted to employees and directors, which results in an estimated option term of six years. For consultant options, the Company uses an estimated option term of four years, which is equal to the period required for the options to vest in full. As the Company gathers more history regarding its option exercise pattern, and as information regarding the option exercise pattern of other companies in its industry becomes publicly available, it will review these estimates and revise them as appropriate. Different estimates of volatility and expected term could materially change the value of an option and the resulting expense.

Recently Issued Accounting Pronouncements

In March 2008, FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging Activities—an amendment of FASB Statement No. 133. This Statement is intended to enhance the current disclosure framework in Statement No. 133. The Statement requires that objectives for using derivative instruments be disclosed in terms of underlying risk and accounting designation. This disclosure better conveys the purpose of derivative use in terms of the risks that the entity is intending to manage. Disclosing the fair values of derivative instruments and their gains and losses in a tabular format should provide a more complete picture of the location in an entity’s financial statements of both the derivative positions existing at period end and the effect of using derivatives during the reporting period. Disclosing information about credit-risk-related contingent features should provide information on the potential effect on an entity’s liquidity from using derivatives. Finally, this Statement requires cross-referencing within the footnotes, which should help users of financial statements locate important information about derivative instruments. The Company does not expect that the adoption of SFAS No. 161 will have a significant impact on the consolidated results of operations or financial position of the Company.

In December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations , or SFAS No. 141R, which replaces SFAS No. 141. SFAS No. 141R establishes principles and requirements for how an acquirer recognizes and measures in its financial statements the identifiable assets acquired, the liabilities assumed, any non-controlling interest in the acquiree and the goodwill acquired. SFAS No. 141R also establishes disclosure requirements which will enable users to evaluate the nature and financial effects of the business combination. SFAS No. 141R is effective for business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. The Company does not expect that the adoption of SFAS No. 141R will have a significant impact on the consolidated results of operations or financial position of the Company.

In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial Statements—an Amendment of Accounting Research Bulletin No. 51 , which establishes accounting and reporting standards for ownership interests in subsidiaries held by parties other than the parent, the amount of consolidated net income attributable to the parent and to the noncontrolling interest, changes in a parent’s ownership interest and the valuation of retained noncontrolling equity investments when a subsidiary is deconsolidated. SFAS No. 160 also establishes reporting requirements that provide sufficient disclosures that clearly identify and distinguish between the interests of the parent and the interests of the noncontrolling owners. SFAS No. 160 is effective for fiscal years, and interim periods within those fiscal years, beginning on or after December 15, 2008. The Company does not expect that the adoption of SFAS No. 160 will have a significant impact on the consolidated results of operations or financial position of the Company.

ITEM 3.

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. 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. However, due to the short duration of our investment portfolio we believe an increase in the interest rates of one percentage point would not be material to our financial condition or results of operations. At September 30, 2008, all of our invested cash was in highly liquid money market accounts. The $225 million up-front payment we received from Pfizer on October 27, 2008 has been fully invested in short-term U.S. Treasury securities and in money market funds consisting solely of short-term U.S. Treasury securities.

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, we expect our exposure to foreign currency exchange rate fluctuations to increase due primarily to the conduct of our confirmatory Phase 3 clinical trial of Dimebon in Alzheimer’s disease. This trial includes clinical sites in Europe and South America, and certain of our payment obligations with respect to those sites will be denominated in foreign currencies. During the three months ended September 30, 2008, there were no material changes to our market risk disclosures as set forth in Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” of our Annual Report on Form 10-KSB for the year ended December 31, 2007.

ITEM 4.

CONTROLS AND PROCEDURES.

Evaluation of disclosure controls and procedures.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the Commission’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

As required by Commission Rule 13a-15(b), we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the quarter covered by this Quarterly Report on Form 10-Q. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of September 30, 2008 at the reasonable assurance level.

Changes in internal controls.

There were no changes in our internal control over financial reporting during the nine months ended September 30, 2008 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Limitations on the effectiveness of controls.

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the control.

The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and we cannot be certain that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met.

PART II. OTHER INFORMATION

ITEM 1.

LEGAL PROCEEDINGS.

None.

ITEM 1A.

RISK FACTORS.

Our business and prospects are subject to the following material risks described below. 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. We have marked with an asterisk (*) those risks described below that reflect substantive changes from the risks described in our Annual Report on Form 10-KSB, filed with the SEC on February 19, 2008.

Risks Related to our Business

We have incurred net losses since inception, expect to incur increasingly large losses in the future as we expand our development activities, and may never achieve revenues or profitability. We are a development stage company and have never recognized any revenue from the sale of products or any other source. We have not completed development of any of our product candidates, and do not expect that any of our present or future product candidates will be commercially available for a number of years, if at all. We have incurred losses since inception and expect to continue to incur substantial and increasing losses for the foreseeable future as we increase our spending to finance clinical and preclinical studies of our existing product candidates, the evaluation, acquisition and development of additional product candidates, additional headcount, and the costs associated with operating as a public company. 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 revenue or become profitable because of the significant uncertainties with respect to our ability to generate revenue from any of our current 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 all of our operations through the sale of our debt and equity securities, and from the $225 million up-front payment we received pursuant to our collaboration agreement with Pfizer. We will require significant additional capital to develop our existing product candidates and to acquire and develop additional product candidates. Our future capital requirements will depend on many factors, including without limitation:

•

the scope and results of our preclinical and clinical trials;

•

whether we experience delays in our preclinical and clinical development programs, or slower than anticipated product development;

•

whether opportunities to acquire additional product candidates arise, and the 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 any of our product candidates and the terms of any such collaboration;

•

the timing and requirements of, and the costs involved in, conducting studies required to obtain regulatory approvals for our product candidates from the FDA and comparable foreign regulatory agencies;

•

the availability of third parties to perform the key development tasks for our 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;

•

the availability and cost of raw materials required to manufacture our product candidates for testing in our preclinical and clinical studies; 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.

We may not be able to obtain additional financing when we need it on acceptable terms or at all. If we cannot raise funds on acceptable terms, we may not be able to continue developing our product candidates, acquire or develop additional product candidates or respond to competitive pressures or unanticipated requirements. For these reasons, any inability to raise additional capital when we require it would seriously harm our business.

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 field is high.

Because we depend on our management to oversee the execution of development plans for our existing product candidates and to identify and acquire promising new product candidates, the loss of any of our managers 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 all of our existing product candidates for acquisition, and has primary responsibility for identifying and evaluating other potential product candidates. We believe that Dr. Hung’s 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 our existing product candidates, 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 developing a manufacturing process at an appropriate scale to manufacture our product candidates to be tested in those studies. In order to manage our business successfully, we will need to identify, engage and properly manage qualified external vendors who 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.

Risks Related to our Product Development Candidates

Our 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. Except for Dimebon’s approval in Russia as an antihistamine, which is not a commercially attractive opportunity for us, none of our product candidates is currently approved for sale anywhere in the world, and none of them may ever receive such approval. The process of conducting the preclinical and clinical testing required to establish safety and efficacy and obtain marketing approval is expensive, uncertain and takes many years. If we are unable to complete preclinical or clinical trials of any of our current 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 attract additional partners or obtain marketing approval for any products. 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.

*Positive results in any of our clinical trials, including our first pivotal clinical trial of Dimebon in Alzheimer’s disease, may not be predictive of future clinical trial results. Even where we achieve positive results in clinical trials, including our first pivotal clinical trial of Dimebon in Alzheimer’s disease conducted in Russia, we do not know whether subsequent clinical trials, including the confirmatory Phase 3 pivotal Alzheimer’s disease clinical trial currently underway in the U.S., Europe and South America will also generate positive results. Product candidates in clinical trials, including Phase 3 clinical trials, often fail to show the desired safety and efficacy traits despite having progressed successfully through prior stages of preclinical and clinical testing. In addition, we do not know whether interim results from any of our ongoing clinical trials, including the interim results of our Phase 1-2 clinical trial of MDV3100 in castration-resistant prostate cancer, will be predictive of final results of any such trial.

*We are dependent upon our collaborative relationship with Pfizer to further develop, manufacture and commercialize Dimebon. There may be circumstances that delay or prevent Pfizer’s ability to development, manufacture and commercialize Dimebon. In September 2008, we entered into a collaboration agreement with Pfizer for the development, manufacture and commercialization of Dimebon to treat Alzheimer’s Disease and Huntington’s Disease. We are dependent on Pfizer for developing, manufacturing and commercializing Dimebon. Under the agreement, Pfizer will be responsible for development and seeking regulatory approval for, and commercialization of, Dimebon outside the United States, and it will be responsible for all manufacture of product for both clinical and commercial purposes. In the United States, Medivation and Pfizer will jointly develop and commercialize Dimebon, and share costs, profits and losses on a 60%/40% basis, with Pfizer assuming the larger share.

We are subject to a number of risks associated with our dependence on our collaborative relationship with Pfizer, including:

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adverse decisions by Pfizer regarding the amount and timing of resource expenditures for the development and commercialization of Dimebon;

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possible disagreements as to the timing, nature and extent of our development plans, including clinical trials or regulatory approval strategy;

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the right of Pfizer to terminate its collaboration agreement with us on limited notice for its convenience;

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loss of significant rights if we fail to meet our obligations under the collaboration agreement;

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withdrawal of support by Pfizer following the development or acquisition by it of competing products, including competing Alzheimer’s disease development candidates that Pfizer already has in its portfolio, or change of Pfizer corporate strategy;

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changes in key management personnel at Pfizer that are members of the collaboration’s various operating committees; and

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possible disagreements with Pfizer regarding the collaboration agreement or ownership of proprietary rights.

Due to these factors and other possible disagreements with Pfizer, we may be delayed or prevented from further developing, manufacturing or commercializing Dimebon, or we may become involved in litigation or arbitration, which would be time consuming and expensive.

The term of our collaboration agreement with Pfizer extends, on a country by country basis, until Pfizer no longer is obligated to pay us royalties for countries outside the United States, or no longer sells the product in the United States. If Pfizer were to unilaterally terminate our collaborative relationship, we would need to undertake development, manufacturing and marketing activities for Dimebon solely at our own expense and/or seek another partner 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, and might limit the indications we are able to pursue and could prevent us from effectively developing and commercializing Dimebon. If we sought to find another pharmaceutical company partner for some or all of these activities, we may not be successful in such efforts, or they may result in a collaboration that has us expending greater funds and efforts than our current relationship with Pfizer.

*We are dependent on the efforts of and funding by Pfizer for the development of Dimebon. Under the terms of the collaboration agreement, we and Pfizer must agree on any changes to the development plan for Dimebon that is set forth in the collaboration agreement. If we and Pfizer cannot agree, clinical trial progress could be significantly delayed or halted. Subject to certain limitations set forth in the collaboration agreement, Pfizer is generally free to terminate our agreement at its discretion on limited notice to us. If Pfizer terminates its co-funding of Dimebon development, we may be unable to fund the development costs on our own and may be unable to find a new collaborator, which could cause our business to fail. In the event of an uncured material breach of the agreement by us, Pfizer may elect either to terminate the agreement or to keep the agreement in place, but terminate our right to participate in development, commercialization (other than co-promoting Dimebon, which right Pfizer may terminate only if our uncured material breach pertains to our exercise of that right) and other activities for Dimebon, including the joint committees and decision making for Dimebon. If Pfizer terminates our right to participate in such activities, we would be entirely dependent on Pfizer’s actions with respect to the development and commercialization of Dimebon. In addition, under our agreement Pfizer is solely responsible for the development and regulatory approval of Dimebon outside the United States, so we are entirely dependent on Pfizer for the successful completion of those activities.

The financial returns to us, if any, under our collaboration agreement with Pfizer depend in large part on the achievement of development and commercialization milestones, plus a share of any profits from sales in the United States and royalties from sales outside the United States. Therefore, our success, and any associated financial returns to us and our investors, will depend in large in part on the performance of Pfizer under the agreement. If Pfizer fails to perform or satisfy its obligations to us, the development, regulatory approval or commercialization of Dimebon 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 Pfizer to market and promote Dimebon. Under our collaboration with Pfizer, we and Pfizer will co-promote Dimebon to specialty physicians in the United States, and Pfizer will promote Dimebon to primary care physicians in the United States. Outside the United States, Pfizer will solely promote Dimebon. We are thus solely dependent on Pfizer to successfully promote Dimebon to primary care physicians in the United States and to all customers outside of the United States, and are partially dependent on Pfizer to successfully promote Dimebon to specialty physicians in the United States. We have limited ability to direct Pfizer in its commercialization of Dimebon in any country, including the United States. If Pfizer fails to adequately market and promote Dimebon, whether inside or outside of the United States, we may be unable to obtain any remedy against Pfizer. If this were to happen, sales of Dimebon may be harmed, which would negatively impact our business, results of operations, cash flows and liquidity.

*We do not have manufacturing expertise or capabilities and are dependent on Pfizer to manufacture clinical and commercial requirements for Dimebon, which could result in the delay of clinical trials or regulatory approval or lost sales. Under our collaboration agreement with Pfizer, after a transition period Pfizer will have the primary right and responsibility to supply Dimebon for clinical trials and all commercial requirements pursuant to a joint manufacturing plan. We lack the resources, experience and capabilities to manufacture Dimebon or any future product candidates on our own and would require substantial funds to establish these capabilities ourselves or to outsource them to third party contract manufacturers. Consequently, we are, and expect to remain, dependent on Pfizer to manufacture Dimebon. Pfizer may encounter difficulties in production scale-up, including problems involving production yields, quality control and quality assurance and shortage of qualified personnel. Pfizer may not perform as agreed or may default in its obligations to supply clinical trial supplies and/or commercial product. Pfizer may fail to deliver the required quantities of our products or product candidates on a timely basis. Any such failure by Pfizer could delay our future clinical trials and our applications for regulatory approval, or could impair our ability to meet the market demand for Dimebon and therefor result in decreased sales. If Pfizer does not adequately perform, we may be forced to incur additional expenses to pay for the manufacture of products or to develop our own manufacturing capabilities.

*If Pfizer’s business strategy changes, it may adversely affect our collaborative relationship. Pfizer may change its business strategy. Decisions by Pfizer to either reduce or eliminate its participation in the Alzheimer’s field, to emphasize other competitive agents currently in its portfolio at the expense of Dimebon, or to add additional competitive agents to its portfolio, could reduce its financial incentive to continue to develop, seek regulatory approval for, or commercialize Dimebon. A change in Pfizer’s business strategy may adversely affect activities under its collaboration agreement with us, which could cause significant delays and funding shortfalls impacting the activities under the collaboration and seriously harming our business.

*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, Pfizer or our 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 U.S., principally the FDA, and by similar agencies in other countries. We will be required to obtain and maintain an effective investigational new drug application to commence human clinical trials in the U.S. 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 candidate’s 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:

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any preclinical test or clinical trial may fail to produce safety and efficacy results satisfactory to the FDA or foreign regulatory authorities;

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preclinical and clinical data can be interpreted in different ways, which could delay, limit or prevent regulatory approval;

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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 successful;

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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;

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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;

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any regulatory approval we, Pfizer 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 our product candidates.

Furthermore, as is typically the case at this stage of the regulatory review process, the FDA has not yet performed an in-depth review of our preclinical and clinical data. Any views the FDA has expressed to us thus remain subject to change, including the view that our previously completed trial conducted in Russia can be used as one of the two pivotal studies required to support the approval of Dimebon to treat mild-to-moderate Alzheimer’s disease, as long as a significant proportion of the sites in the confirmatory Phase 3 trial are located in the U.S.

*Enrollment of patients in clinical trials is often an expensive and time-consuming process, and could result in significant delays, cost overruns, or both, in our product development activities. We may encounter delays in enrolling a sufficient number of patients to complete our clinical trials. Patient enrollment depends on many factors, including the size of the patient population, the nature of the trial protocol, the proximity of patients to clinical sites and the eligibility criteria for the study. In particular, our Phase 3 confirmatory pivotal Phase 3 trial of Dimebon in Alzheimer’s disease is evaluating Dimebon as a “monotherapy” in Alzheimer’s disease patients—meaning that patients in the placebo group do not receive treatment with any approved Alzheimer’s disease drugs. Because approved Alzheimer’s disease drugs are widely available in the U.S. and Europe, we believe that patient accrual in Dimebon monotherapy studies, including our confirmatory pivotal Phase 3 trial of Dimebon in Alzheimer’s disease, may be particularly time-consuming. Delays in planned patient enrollment may result in increased costs, program delays or both, which could have a harmful effect on our ability to develop Dimebon or any other product candidates.

*Although we have entered into a collaboration agreement with Pfizer for Dimebon, we have not yet partnered any of our other product development candidates with third party collaborators, and we cannot control whether we will be able to do so on favorable terms or at all. Our business strategy relies in part on potentially partnering successful product development candidates with larger companies to complement our internal development and commercialization efforts. We may also be required to enter into collaborative relationships to complement our internal efforts, whether in research and development, manufacturing or commercialization, and/or to generate necessary financing. It may be difficult for us to find third parties that are willing to enter into such transactions on acceptable economic terms or at all. We also will be competing with many other companies as we seek partners for our product candidates, and we may not be able to compete successfully against those other firms. If we are not able to enter into collaboration transactions for our other product development candidates, we would be required to undertake and fund further development, clinical trials, manufacturing and commercialization activities solely at our own expense and risk. If we are unable to finance and/or successfully execute those expensive activities, our business and prospects would be materially and adversely harmed for that reason.

We expect that the financial returns to us in any collaboration agreement would depend in large part on the achievement of development and/or commercialization milestones for, and royalties, co-promotion fees or other payments based upon sales of, our product candidates. Therefore, our success, and any associated financial returns to us and our investors, will depend on the ability of Pfizer and any of our future collaborators to obtain and maintain regulatory approvals from the FDA and other foreign regulatory agencies and successfully commercialize our product candidates. We may also be dependent on our collaborators for the commercial scale manufacture, distribution, sales, marketing and reimbursement of our product candidates. These collaborators may not be successful. If Pfizer or any future collaborator terminates its collaboration with us or fails to perform or satisfy its obligations to us, the development, regulatory approval or commercialization of our product candidates would be delayed or may not occur and our business and prospects could be materially and adversely affected for that reason.

*If our product candidates cannot be manufactured in a cost-effective manner and in compliance with current good manufacturing practices and other applicable regulatory standards, they will not be commercially successful . All pharmaceutical and medical device products in the U.S., Europe and other countries must be manufactured in strict compliance with current good manufacturing practices, or cGMP, and other applicable regulatory standards. Establishing a cGMP-compliant process to manufacture pharmaceutical and medical

device 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. Under our collaboration agreement with Pfizer, Pfizer is responsible for all manufacture of Dimebon for both clinical and commercial purposes, but we cannot guarantee that Pfizer will be able to manufacture Dimebon in a timely manner or at all. Furthermore, neither Dimebon nor MDV3100 has been manufactured at commercial-scale under cGMP-compliant conditions. We thus cannot guarantee that commercial-scale cGMP manufacture of Dimebon and/or MDV3100 will be possible, on a cost-effective basis or at all, which would materially and adversely affect the value of these programs.

*Any of our product development candidates that receive marketing approval will face significant competition from other approved products, including generic products and products with more convenient dosing regimens, 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, there are four drugs currently marketed to treat Alzheimer’s disease. These drugs are all dosed once or twice per day, while Dimebon was dosed three times per day in our first pivotal clinical trial and also is being dosed three times per day in our confirmatory Phase 3 pivotal clinical trial. This difference in dosing regimen may make Dimebon less competitive than alternative Alzheimer’s disease drugs if Dimebon receives marketing approval based on a thrice per day dosing regimen. In addition, all four currently approved Alzheimer’s disease drugs are expected to lose patent protection prior to, or shortly after, Dimebon’s potential launch. Such loss of patent protection would likely result in the entry of generic competition for, and significant reductions in the commercial pricing of, those approved drugs. This development would put significant competitive pressure on the prices we or our potential partners could charge for Dimebon should it ever be approved. Companies marketing currently approved Alzheimer’s disease therapeutics include some of the world’s largest and most experienced pharmaceutical companies, such as Pfizer, Novartis AG and Johnson & Johnson. There are also dozens of additional small molecule and recombinant protein candidates in development targeting the clinical indications we are pursuing, particularly Alzheimer’s disease and castration-resistant prostate cancer, including compounds already in Phase 3 clinical trials and other compounds in development by Pfizer for Alzheimer’s disease. One or more such compounds may be approved in each of our target indications before any of our product candidates could potentially be approved. 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 receives regulatory approval will face significant competition from both approved drugs, as well as 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. Even if one of our product candidates is approved, we cannot guarantee that we, Pfizer 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, Pfizer or our potential future partners cannot compete successfully on any of the bases described above, our business will not succeed.

Any of our product candidates that is eventually approved for sale may not be commercially successful if not widely-covered and appropriately reimbursed by third-party payors. 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 U.S. 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, our product candidates are unlikely to achieve commercial success unless they are covered widely by third-party payors and reimbursed at a rate which generates an acceptable commercial return for us and any collaborative partner. 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. 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 Pfizer, 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. The competition for coverage and reimbursement level with individual payors will be particularly intense for Dimebon, if approved to treat Alzheimer’s disease, because all four currently marketed Alzheimer’s disease drugs are expected to lose patent protection prior to, or shortly following, Dimebon’s potential commercial launch, and thus are likely to be available at generic price levels that are more attractive to individual payors. Our commercial prospects would be further weakened if payors approved coverage for our product candidates only as second- or later-line treatments, or if they placed any of our product candidates in tiers requiring unacceptably high patient co-payments. Failure to achieve acceptable coverage and reimbursement levels could materially harm our or our partner’s ability to successfully market our product candidates.

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 any of our product candidates 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 could require significant involvement of our senior management and may divert management’s 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.

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 protection—primarily patent protection—of our technologies and 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 U.S. 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:

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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;

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we or our licensors might not have been the first to file patent applications for these inventions;

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others may independently develop similar or alternative technologies or duplicate any of our technologies;

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it is possible that none of our pending patent applications or the pending patent applications of our licensors will result in issued patents;

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our issued patents and future issued patents, or those of our licensors, may not provide a basis for commercially viable products, may not provide us with any competitive advantages, or may be challenged by third parties and invalidated; and

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we may not develop additional proprietary technologies or product candidates that are patentable.

Our existing and any future patent rights may not adequately protect any of our 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 our 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 MDV300 series compounds. Since our 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 also 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 has been significant litigation in the U.S. 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 any of our present or future product candidates succeed, we may face similar challenges to our existing or future patents. For example, in the prosecution of our issued U.S. patents claiming the use of Dimebon and certain related compounds to treat neurodegenerative diseases, including Alzheimer’s disease, the prior owners missed a filing deadline with the U.S. Patent & Trademark Office, or PTO, which resulted in the patent application being deemed abandoned. The prior owners petitioned the PTO to revive the patent application alleging that missing the deadline was unintentional, and the PTO approved the petition and issued the patent. However, as with any other decision the PTO makes, this decision could be challenged in subsequent litigation in an attempt to invalidate this issued U.S. patent and any other U.S. patent that may issue based on the same patent application. If a generic pharmaceutical company or other third party were able to successfully invalidate any of our present or future patents, any of our 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 party’s 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:

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discontinue our products that use the challenged intellectual property; or

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obtain from the owner of the 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 management’s 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 may need to obtain 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. From time to time we may be required to license technology from third parties to develop our existing and future product candidates. For example, in our industry there are a large number of issued patents and published patent applications with claims to treating diseases generically through use of any product that produces one or more biological activities—such as inhibiting a specific biological target. We are aware of several such issued patents relating to Alzheimer’s disease, and expect to continue to encounter such patents relating to other diseases targeted by our present and future product candidates. We have not conducted experiments to analyze whether, and we have no evidence that, any of our product candidates produce the specific biological activities covered in any of the issued patents or published patent applications of which we are presently aware. We have not sought to acquire licenses to any such patents. In addition, the commercial scale manufacturing processes that we are developing for our product candidates may require licenses to third party technology. Should we be required to obtain 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 Pfizer or 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 collaborative agreements, including our collaboration agreement with Pfizer, 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 our 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 U.S. 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

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 Quarterly Report on Form 10-Q, may have a significant impact on the market price of our common stock:

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the receipt or failure to receive the additional funding necessary to conduct our business;

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the progress and success of preclinical studies and clinical trials of our product candidates conducted by us, Pfizer or our future collaborative partners or licensees, if any;

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selling by existing stockholders and short-sellers;

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announcements of technological innovations or new commercial products by our competitors or us;

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developments concerning proprietary rights, including patents;

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developments concerning our collaboration with Pfizer or any future collaborations;

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publicity regarding us, our product candidates or those of our competitors, including research reports published by securities analysts;

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regulatory developments in the U.S. and foreign countries;

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litigation;

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economic and other external factors or other disaster or crisis; and

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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. Please refer to Item 11: “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” in our Annual Report on Form 10-KSB for the year ended December 31, 2007 for more information. 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.

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. In addition, 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 the company and an “interested stockholder” of the company. 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.

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

On September 3, 2008, we issued 5,496 shares of our common stock to a warrant holder upon the net exercise of the warrant by the holder. We received no additional consideration in connection with this issuance. For this issuance, we relied on the exemption provided by Section 4(2) of the Securities Act of 1933, as amended, based upon the number of persons receiving shares of our common stock in the transaction, their financial position, sophistication and relationship to us and the absence of any general solicitation.

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES.

None.

ITEM 4.

SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.

None.

ITEM 5.

OTHER INFORMATION

None.

ITEM 6.

EXHIBITS.


EXHIBIT NO.		DESCRIPTION

3.1(a)		Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1(a) to the Quarterly Report on Form 10-QSB of Medivation, Inc. for the quarter ended June 30, 2005).

3.1(b)		Certificate of Amendment of Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1(b) to the Quarterly Report on Form 10-QSB of Medivation, Inc. for the quarter ended June 30, 2005).

3.1(c)		Certificate of Amendment to the Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1(c) to the Quarterly Report on Form 10-QSB of Medivation, Inc. for the quarter ended June 30, 2005).

3.1(d)		Certificate of Designations of the Series C Junior Participating Preferred Stock of Medivation, Inc. (incorporated by reference to Exhibit 3.1(d) to the Annual Report on Form 10-KSB of Medivation, Inc. for the year ended December 31, 2007).

3.2		Bylaws of Medivation, Inc. (formerly Orion Acquisition Corp. II), together with all amendments and restatements thereto (incorporated by reference to Exhibit 3.2 to the Registration Statement on Form SB-2 of Medivation, Inc. (formerly Orion Acquisition Corp. II) (No. 333-03252)).

4.1		Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Registration Statement on Form SB-2 of Medivation, Inc. (formerly Orion Acquisition Corp. II) (No. 333-03252)).

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 (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed on December 4, 2006).

10.8*		Amended and Restated Collaboration Agreement, dated as of October 20, 2008, between Medivation, Inc. and Pfizer Inc.

31.1		Certification of President and Chief Executive Officer pursuant to Rules 13a-14(a) or 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended

31.2		Certification of Senior Vice President and Chief Financial Officer pursuant to Rules 13a-14(a) or 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended

32.1		Certification of the Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

*	Confidential treatment requested as to certain portions, which portions were omitted and filed separately with the Securities and Exchange Commission.

SIGNATURES

Pursuant to the requirements 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.

Date: November 10, 2008	By:	/s/ C. PATRICK MACHADO
	Name:	C. Patrick Machado
	Title:	Senior Vice President and Chief Financial Officer (Duly Authorized Officer and Principal Financial Officer)

EXHIBIT INDEX


EXHIBIT NO.		DESCRIPTION

3.1(a)		Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1(a) to the Quarterly Report on Form 10-QSB of Medivation, Inc. for the quarter ended June 30, 2005).

3.1(b)		Certificate of Amendment of Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1(b) to the Quarterly Report on Form 10-QSB of Medivation, Inc. for the quarter ended June 30, 2005).

3.1(c)		Certificate of Amendment to the Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1(c) to the Quarterly Report on Form 10-QSB of Medivation, Inc. for the quarter ended June 30, 2005).

3.1(d)		Certificate of Designations of the Series C Junior Participating Preferred Stock of Medivation, Inc. (incorporated by reference to Exhibit 3.1(d) to the Annual Report on Form 10-KSB of Medivation, Inc. for the year ended December 31, 2007).

3.2		Bylaws of Medivation, Inc. (formerly Orion Acquisition Corp. II), together with all amendments and restatements thereto (incorporated by reference to Exhibit 3.2 to the Registration Statement on Form SB-2 of Medivation, Inc. (formerly Orion Acquisition Corp. II) (No. 333-03252)).

4.1		Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Registration Statement on Form SB-2 of Medivation, Inc. (formerly Orion Acquisition Corp. II) (No. 333-03252)).

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 (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed on December 4, 2006).

10.8*		Amended and Restated Collaboration Agreement, dated as of October 20, 2008, between Medivation, Inc. and Pfizer Inc.

31.1		Certification of President and Chief Executive Officer pursuant to Rules 13a-14(a) or 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended

31.2		Certification of Senior Vice President and Chief Financial Officer pursuant to Rules 13a-14(a) or 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended

32.1		Certification of the Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

*	Confidential treatment requested as to certain portions, which portions were omitted and filed separately with the Securities and Exchange Commission.

EX-10.8 2 dex108.htm AMENDED AND RESTATED COLLABORATION AGREEMENT BETWEEN MEDIVATION, INC. AND PFIZER Amended and Restated Collaboration Agreement between Medivation, Inc. and Pfizer

Exhibit 10.8

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

AMENDED AND RESTATED

COLLABORATION AGREEMENT

by and between

Medivation, Inc.

and

Pfizer Inc.

Signing Date: August 29, 2008

As Amended and Restated: October 20, 2008

Effective Date: October 21, 2008

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ARTICLE 1 DEFINITIONS		1

1.1	“2003 OIG Guidance”	2

1.2	“ACCME Standards”	2

1.3	“Acquiror”	2

1.4	“Acquisition”	2

1.5	“Affiliate”	2

1.6	“Anticipated Approval Date”	2

1.7	“Applicable Laws”	2

1.8	“Approved Third Party Payment”	2

1.9	“Backup Product”	2

1.10	“Bankrupt Party”	2

1.11	“Business Combination”	2

1.12	“Business Day”	2

1.13	“Calendar Quarter”	3

1.14	“Calendar Year”	3

1.15	“Claim”	3

1.16	“Clinical Trial”	3

1.17	“CMC Development”	3

1.18	“Collaboration”	3

1.19	“Collaboration Molecule”	3

1.20	“Collaboration Patents”	3

1.21	“Commercialization”	3

1.22	“Commercialization Costs”	3

1.23	“Committee”	3

1.24	“Complete Response Letter”	4

1.25	“Competing Product”	4

1.26	“Confidential Information”	4

1.27	“Control”	4

1.28	“Co-Promotion” or “Co-Promote”	4

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1.29	“Co-Promotion Period”	4

1.30	“Co-Promotion Product”	4

1.31	“Detail” or “Detailing”	5

1.32	“Detail Cost”	5

1.33	“Development”	5

1.34	“Development Costs”	5

1.35	“Development FTE”	6

1.36	“Development FTE Rate”	6

1.37	“Development Program”	6

1.38	“Diligent Efforts”	6

1.39	“Dimebon”	6

1.40	“Dimebon Product”	6

1.41	“Distribution Costs”	6

1.42	“DoJ”	7

1.43	“Effective Date”	7

1.44	“EMEA”	7

1.45	“Europe”	7

1.46	“European Union”	7

1.47	“Executive Officer”	7

1.48	“Existing Confidentiality Agreement”	7

1.49	“FCPA”	7

1.50	“FDA”	7

1.51	“FD&C Act”	7

1.52	“Field”	7

1.53	“Field Force Detailing Costs”	7

1.54	“Field Force Detailing Plan”	7

1.55	“First Commercial Sale”	7

1.56	“FTC”	8

1.57	“GCPs”	8

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1.58	“GLPs”	8

1.59	“GMPs”	8

1.60	“Generic Product”	8

1.61	“Governmental Authority”	8

1.62	“HSR Act”	8

1.63	“HSR Conditions”	8

1.64	“Huntington’s Disease”	8

1.65	“IND”	9

1.66	“Indemnifying Party”	9

1.67	“Information”	9

1.68	“Initial Approval Date”	9

1.69	“Initial Approval Studies”	9

1.70	“Initial Dimebon Product”	9

1.71	“Initial Indications”	9

1.72	“Initial Joint Development Plan”	9

1.73	“Initial Shared Territory Commercialization Budget”	9

1.74	“Initial Shared Territory Commercialization Plan”	9

1.75	“Joint Commercialization Committee” or “JCC”	9

1.76	“Joint Commercialization Costs”	9

1.77	“Joint Development Budget”	10

1.78	“Joint Development Committee” or “JDC”	10

1.79	“Joint Development Costs”	10

1.80	“Joint Development Plan”	11

1.81	“Joint Inventions”	11

1.82	“Joint Manufacturing Budget”	11

1.83	“Joint Manufacturing Plan”	11

1.84	“Joint Manufacturing Committee” or “JMC”	11

1.85	“Joint Patent”	11

1.86	“Joint Regulatory Committee” or “JRC”	11

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1.87	“Joint Steering Committee” or “JSC”	11

1.88	“Key Markets”	11

1.89	“Launch Product Volume”	11

1.90	“Launch Product Volume Criteria”	11

1.91	“Licensed Territory”	11

1.92	“Manufacturing Costs”	11

1.93	“Marketing Authorization Application” or “MAA”	13

1.94	“Marks”	13

1.95	“Materials”	13

1.96	“Medical Education Activities”	13

1.97	“Medivation Claims”	13

1.98	“Medivation Damages”	13

1.99	“Medivation Detail Requirement”	13

1.100	“Medivation Indemnitees”	13

1.101	“Medivation Know-How”	13

1.102	“Medivation Patents”	14

1.103	“Medivation Sales Force”	14

1.104	“Medivation Sales Force Trainers”	14

1.105	“Medivation Sales Representatives”	14

1.106	“Medivation Technology”	14

1.107	“MHLW”	14

1.108	“MMA”	14

1.109	“NDA”	14

1.110	“Net Sales”	14

1.111	“Non-Clinical Studies”	16

1.112	“Non-Prescriber”	16

1.113	“OIG”	16

1.114	“Operating Profit (or Loss)”	16

1.115	“Other Indications”	16

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1.116	“Other Patented Molecule”	16

1.117	“Partner CIA”	16

1.118	“Partner Claims”	16

1.119	“Partner Damages”	16

1.120	“Partner Indemnitees”	16

1.121	“Partner Know-How”	17

1.122	“Partner Patents”	17

1.123	“Partner Quarter”	17

1.124	“Partner Technology”	17

1.125	“Partner Year”	17

1.126	“Partner Withholding Tax Action”	17

1.127	“PCP Sales Representative Detail Cost”	17

1.128	“PDM Act”	17

1.129	“Phase 4 Clinical Trial”	18

1.130	“PhRMA”	18

1.131	“PhRMA Code”	18

1.132	“PMDA”	18

1.133	“Pre-Launch Manufacturing and CMC Development Cost Cap”	18

1.134	“Price Approval”	18

1.135	“Product”	18

1.136	“Product Infringement”	18

1.137	“Promotional Materials”	18

1.138	“Publication”	18

1.139	“[*]”	18

1.140	“Regulatory Approval”	19

1.141	“Regulatory Authority”	19

1.142	“Regulatory Costs”	19

1.143	“Regulatory Exclusivity”	19

1.144	“Regulatory Issue”	19

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1.145	“Regulatory Materials”	19

1.146	“Restricted Product”	19

1.147	“Reverted Partner Know-How”	19

1.148	“Reverted Partner Patents”	19

1.149	“Royalty Term”	20

1.150	“Sales and Marketing Costs”	20

1.151	“Sales Call”	20

1.152	“Safe Harbor Regulations”	20

1.153	“Safety Risk”	20

1.154	“Sales Representative”	20

1.155	“Samples”	20

1.156	“SEC”	20

1.157	“Shared Territory”	20

1.158	“Shared Territory Commercialization Budget”	21

1.159	“Shared Territory Commercialization Plan”	21

1.160	“Sole Inventions”	21

1.161	“Specialist”	21

1.162	“Specialist Sales Representative Detail Cost”	21

1.163	“Specialty Detail Effort”	21

1.164	“Standstill Period”	21

1.165	“Standstill Provisions”	21

1.166	“Sublicense or Subcontractor Agreement”	21

1.167	“Sublicensee”	21

1.168	“Target”	21

1.169	“Tax”	21

1.170	“Term”	21

1.171	“Territory”	21

1.172	“Third Party”	22

1.173	“Third Party Licenses”	22

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1.174	“Third Party Payment”	22

1.175	“Trademark Costs”	22

1.176	“Training Program”	22

1.177	“Trigger Event”	22

1.178	“U.S.”	22

1.179	“US GAAP”	22

1.180	“Valid Claim”	22

ARTICLE 2 COLLABORATION; GOVERNANCE		23

2.1	Collaboration Overview	23

2.2	Joint Steering Committee	23

2.3	Joint Development Committee	25

2.4	Joint Regulatory Committee	27

2.5	Joint Manufacturing Committee	29

2.6	Joint Commercialization Committee	31

2.7	Resolution of Committee Disputes	33

2.8	Appointment of Alliance Managers	36

2.9	General Committee Authority	37

2.10	Discontinuation of Participation on a Committee	37

ARTICLE 3 DEVELOPMENT		37

3.1	Overview	37

3.2	Development Program	37

3.3	Development Diligence and Standards of Conduct	40

3.4	Development Records and Reports	40

3.5	Subcontracts	41

ARTICLE 4 REGULATORY MATTERS		41

4.1	Regulatory Filings and Approvals	41

4.2	Regulatory Costs	42

4.3	Product Withdrawals and Recalls	43

4.4	Safety Reporting	43

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4.5	Standards of Conduct	43

4.6	Subcontracts	43

ARTICLE 5 COMMERCIALIZATION		44

5.1	Overview	44

5.2	Shared Territory Commercialization Plan	44

5.3	Amendments to the Joint Commercialization Plans and Budgets	45

5.4	Licensed Territory Commercialization Plans	45

5.5	Commercialization Costs	46

5.6	Sales and Distribution	46

5.7	Commercialization Reports	46

5.8	Commercialization Standards of Conduct	46

5.9	Subcontracts	47

5.10	Co-Promotion of Products by Medivation	47

5.11	Co-Promotion Terms	50

ARTICLE 6 MANUFACTURE AND SUPPLY		56

6.1	Overview	56

6.2	Joint Manufacturing Plan	56

6.3	Manufacturing Responsibilities	57

6.4	Allocation of Manufacturing Costs Under the Joint Manufacturing Plan	58

6.5	Manufacturing Standards of Conduct	58

6.6	Manufacturing Records and Reports	58

6.7	Subcontracts; Affiliates	59

6.8	Transfer of Manufacturing Technology	59

ARTICLE 7 LICENSES AND EXCLUSIVITY		59

7.1	License to Partner under Medivation Technology	59

7.2	Licenses to Medivation under Partner Technology and Medivation Technology	59

7.3	Research Licenses	60

7.4	Sublicensing	60

7.5	Negative Covenant	61

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7.6	No Implied Licenses	61

7.7	Third Party Payments	61

7.8	Compensation to Inventors of Medivation Patents	62

7.9	Exclusivity	62

ARTICLE 8 FINANCIALS		65

8.1	License Fee	65

8.2	Profit Sharing in the Shared Territory	66

8.3	Regulatory Milestone Payments	67

8.4	Sales Milestone Payments	68

8.5	Royalties	69

8.6	Notices of Termination	71

8.7	Taxes	71

8.8	Blocked Currency	72

8.9	Foreign Exchange	72

8.10	Late Payments	72

8.11	Financial Records; Audits	73

8.12	Manner and Place of Payment	73

ARTICLE 9 INTELLECTUAL PROPERTY		74

9.1	Ownership of Inventions	74

9.2	Disclosure of Inventions	74

9.3	Prosecution of Patents	74

9.4	Infringement of Collaboration Patents by Third Parties	77

9.5	Defense of Collaboration Patents	78

9.6	Defense of Infringement Actions	79

9.7	Patent Marking	79

9.8	Personnel Obligations	79

9.9	Trademarks, Corporate Logos and other Intellectual Property Rights	80

ARTICLE 10 REPRESENTATIONS AND WARRANTIES; COVENANTS; HSR		80

10.1	Mutual Representations and Warranties	80

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10.2	Representations and Warranties by Medivation	81

10.3	Covenants	84

10.4	Disclaimer	86

10.5	No Other Representations or Warranties	86

10.6	HSR	86

ARTICLE 11 INDEMNIFICATION		87

11.1	Indemnification by Medivation	87

11.2	Indemnification by Partner	88

11.3	Indemnification Procedures	88

11.4	Third Party Claims Related To Products In The Shared Territory	88

11.5	Insurance	89

ARTICLE 12 CONFIDENTIALITY		89

12.1	Confidentiality	89

12.2	Authorized Disclosure	90

12.3	Publicity	91

12.4	Publications	92

ARTICLE 13 TERM AND TERMINATION		93

13.1	Term	93

13.2	Termination by Partner at Will	93

13.3	Termination by Either Party for Breach	93

13.4	Termination by either Party due to Non-occurrence of Effective Date	94

13.5	Effects of Termination of the Agreement	94

13.6	Medivation’s Material Breach	96

13.7	Other Remedies	97

13.8	Rights in Bankruptcy	97

13.9	Survival	98

ARTICLE 14 DISPUTE RESOLUTION		98

14.1	Disputes	98

14.2	Arbitration	98

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14.3	Governing Law	99

14.4	Award	99

14.5	Costs	100

14.6	Injunctive Relief	100

14.7	Confidentiality	100

14.8	Survivability	100

14.9	Jurisdiction	100

14.10	Patent and Trademark Disputes	100

ARTICLE 15 MISCELLANEOUS		101

15.1	Entire Agreement; Amendment	101

15.2	Force Majeure	101

15.3	Notices	101

15.4	No Strict Construction; Headings	103

15.5	Assignment	103

15.6	Standstill	103

15.7	Performance by Affiliates	106

15.8	Further Actions	106

15.9	Compliance with Applicable Law	106

15.10	Limitation of Liability	106

15.11	Severability	106

15.12	No Waiver	106

15.13	Independent Contractors	107

15.14	Third Party Beneficiary	107

15.15	Counterparts	107

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EXECUTION VERSION

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

AMENDED AND RESTATED COLLABORATION AGREEMENT

THIS AMENDED AND RESTATED COLLABORATION AGREEMENT (the “Agreement”) is entered into as of August 29, 2008 (the “Signing Date”) and amended and restated as of October 20, 2008 by and between MEDIVATION, INC., a Delaware corporation having its principal place of business at 201 Spear Street, 3^rd Floor, San Francisco, California 94105, United States (“Medivation”) and PFIZER INC., a Delaware corporation having its principal place of business at 235 East 42^nd Street, New York, New York 10017 (“Partner”). Medivation and Partner are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

BACKGROUND

Partner is a fully-integrated pharmaceutical company with expertise in the development, manufacture and commercialization of human therapeutic products.

Medivation is a biotechnology company with expertise and experience in the identification and development of product candidates for multiple indications, including neurological indications.

Medivation is conducting Phase 3 human clinical trials with respect to Dimebon^TM for the treatment of Alzheimer’s disease and will be conducting a Phase 3 human clinical trial in Huntington’s disease.

Partner and Medivation desire to establish a broad, worldwide, strategic collaboration for the joint continued development and, if successful, regulatory approval for and commercialization of Dimebon, in both its existing formulation and one new formulation.

NOW THEREFORE, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

As used in this Agreement, the following initially capitalized terms, whether used in the singular or plural form, shall have the meanings set forth in this Article 1. In addition, the terms “includes,” “including,” “include” and derivative forms of them shall be deemed followed by the phrase “without limitation” (regardless of whether it is actually written there (and drawing no implication from the actual inclusion of such phrase in some instances after such terms but not others)).

1.1 “2003 OIG Guidance” has the meaning set forth in Section 5.11(j)(i).

1.2 “ACCME Standards” has the meaning set forth in Section 5.11(j)(i).

1.3 “Acquiror” has the meaning set forth in Section 15.5.

1.4 “Acquisition” has the meaning set forth in Section 15.6(d).

1.5 “Affiliate” means, with respect to a particular Party, a person, corporation, partnership, or other entity that directly or indirectly controls, is controlled by or is under common control with such Party. For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under the common control with”) means the possession, either directly or indirectly through one or more intermediaries, of (a) power to direct or cause the direction of the management or policies of such entity (whether through ownership of securities or other ownership interests, by contract or otherwise), or (b) beneficial ownership of at least 50% of the voting securities or other ownership interest (whether directly or pursuant to any option, warrant or other similar arrangement) or other comparable equity interests of an entity.

1.6 “Anticipated Approval Date” has the meaning set forth in Section 5.3.

1.7 “Applicable Laws” means, with respect to a given country, the applicable laws, rules and regulations that may be in effect from time to time in such country and that relate to a Party’s activities under this Agreement, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities of such country.

1.8 “Approved Third Party Payment” has the meaning set forth in Section 7.7.

1.9 “Backup Product” means a Product containing an Other Patented Molecule Developed or Commercialized by the Parties following any termination of Development of Dimebon Products for technical, medical or scientific reasons.

1.10 “Bankrupt Party” has the meaning set forth in Section 13.8.

1.11 “Business Combination” means, with respect to a Party, an acquisition, merger, reorganization, consolidation or other business combination involving such Party or any of its subsidiaries or material assets, or a disposition of all or substantially all of the assets of such Party or any of its subsidiaries.

1.12 “Business Day” means a day other than a Saturday, Sunday, or bank or other public holiday in New York, New York.

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1.13 “Calendar Quarter” means for each Calendar Year, each of the three (3) month periods ending March 31, June 30, September 30 and December 31; provided, however, that the first Calendar Quarter for the first Calendar Year shall extend from the Effective Date to the end of the first complete calendar quarter thereafter.

1.14 “Calendar Year” means, for the first calendar year, the period commencing on the Effective Date and ending on December 31 of the calendar year during which the Effective Date occurs, and each successive period beginning on January 1 and ending twelve (12) consecutive calendar months later on December 31.

1.15 “Claim” has the meaning set forth in Section 11.3.

1.16 “Clinical Trial” means any human clinical trial of a Product.

1.17 “CMC Development” means the activities to enable Development of the Collaboration Molecules and Products and design of the manufacturing process for the supply of clinical and commercial quantities of Product which include manufacturing process development and scale-up, bulk production and fill/finish work associated with the supply of Product for Non-Clinical Studies and Clinical Trials, and related quality assurance technical support activities as well as validation and qualification of commercial manufacturing processes.

1.18 “Collaboration” has the meaning set forth in Section 2.1.

1.19 “Collaboration Molecule” means

(a) Dimebon; or

(b) any Other Patented Molecule.

1.20 “Collaboration Patents” means all Medivation Patents, all Partner Patents claiming Sole Inventions and all Joint Patents.

1.21 “Commercialization” means the commercial manufacture, marketing, promotion, sale and/or distribution of Product in the Territory. Commercialization shall include commercial activities in preparation for the First Commercial Sale of Product. “Commercialize” has a correlative meaning.

1.22 “Commercialization Costs” means all costs incurred by or on behalf of either Party that are directly and reasonably allocable to the Commercialization of Products in the Territory. Commercialization Costs shall specifically exclude corporate overhead of each Party and [*].

1.23 “Committee” means the Joint Steering Committee, Joint Development Committee, Joint Manufacturing Committee, Joint Commercialization Committee, or Joint Regulatory Committee, or any other subcommittee established under Article 2, as applicable.

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1.24 “Complete Response Letter” means (a) a response from the FDA following the first acceptance by the FDA of the filing of the first NDA for a particular Product indicating that the Regulatory Approval of such NDA is delayed or conditioned upon additional information becoming available or additional activities being performed for such Product or (b) a response from the applicable Regulatory Authority following the first filing of an MAA for a particular Product (and, if applicable, acceptance of such filing by the applicable Regulatory Authority) that the Regulatory Approval of such MAA is delayed or conditioned upon additional information becoming available or additional activities being performed with respect to the Product.

1.25 “Competing Product” means any pharmaceutical product used in the Field containing an active pharmaceutical ingredient which mediates its therapeutic effect through the same primary molecular target(s) as Dimebon other than (i) Products and (ii) any pharmaceutical compounds or pharmaceutical products whose primary mechanism of action is listed in Exhibit A.

1.26 “Confidential Information” means, with respect to a Party, and subject to the last paragraph of Section 12.1, all Information of such Party that is disclosed to the other Party under this Agreement, which may include, without limitation, specifications, know-how, trade secrets, technical information, models, business information, inventions, discoveries, methods, procedures, formulae, protocols, techniques, data, and unpublished patent applications, whether disclosed in oral, written, graphic, or electronic form. All confidential Information disclosed by either Party pursuant to the Existing Confidentiality Agreement shall be deemed to be the disclosing Party’s Confidential Information hereunder (with the mutual understanding and agreement that any use or disclosure thereof that is authorized under Article 12 shall not be restricted by, or be deemed a violation of, such Existing Confidentiality Agreement).

1.27 “Control” means, with respect to any material, Information, or intellectual property right, that a Party (a) owns such material, Information, or intellectual property right, or (b) has a license or right to use such material, Information, or intellectual property right, in each case with the ability to grant to the other Party access, a right to use, a license, or a sublicense (as applicable) to such material, Information, or intellectual property right on the terms and conditions set forth herein, without violating the terms of any agreement or other arrangement with any Third Party.

1.28 “Co-Promotion” or “Co-Promote” means those Detailing, marketing and promotional activities (including without limitation performing Sales Calls), under the same Product trademark, with respect to a Co-Promotion Product undertaken by personnel of either Party to encourage appropriate prescribing of such Co-Promotion Product in the Shared Territory.

1.29 “Co-Promotion Period” has the meaning set forth in Section 5.10(c).

1.30 “Co-Promotion Product” has the meaning set forth in Section 5.10(b).

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1.31 “Detail” or “Detailing” means, with respect to a Product, the communication by a Sales Representative during a Sales Call (a) involving face-to-face contact, (b) describing in a fair and balanced manner the FDA-approved uses and other relevant characteristics of such Product, (c) using the Promotional Materials in an effort to increase the prescribing and/or hospital ordering preferences of a Product for its FDA-approved uses in a manner consistent with this Agreement, and (d) made at such medical professional’s office, in a hospital, skilled nursing facility, assisted living facility, at marketing meetings sponsored by a Party for the Product or other appropriate venues conducive to pharmaceutical product informational communication where the principal objective is to place an emphasis on a Product with such medical professional. Details shall be measured by each Party’s internal recording of such activity; provided that such measurement shall be on the same basis as the recording Party’s measurement for its Sales Representatives’ detailing of such recording Party’s other products, consistently applied throughout the Term. If a Party has no other marketed products, subject to Section 5.10(d)(ii), it will establish a basis of internal recording of Details that is reasonable as a basis for recording Details. For the avoidance of doubt, discussions at conventions or other meetings not specifically sponsored by a Party for a Product shall not constitute “Details” or “Detailing”.

1.32 “Detail Cost” means the PCP Sales Representative Detail Cost and the Specialist Sales Representative Detail Cost.

1.33 “Development” means all activities that relate to the development of Collaboration Molecules and Product including (a) obtaining, maintaining or expanding Regulatory Approval of a Product, for one or more indications and (b) CMC Development. This includes: (i) research, preclinical testing, toxicology, and Clinical Trials; and (ii) preparation, submission, review, and development of data or Information for the purpose of submission to a Governmental Authority to obtain, maintain and/or expand Regulatory Approval of a Product; provided, however, that Development shall exclude Commercialization activities and the building of commercial inventory of Product or the building or construction of any manufacturing facilities. For clarity, Development shall include Phase 4 Clinical Trials that are required by a Regulatory Authority as a condition of a Regulatory Approval. “Develop” has a correlative meaning.

1.34 “Development Costs” means all costs incurred by or on behalf of either Party that are reasonably and directly allocable to the Development of Products in the Territory. Development Costs shall include Development FTEs and out-of-pocket costs actually incurred by each Party, including costs of Product or any comparator drug used in Clinical Studies, but shall specifically exclude corporate overhead of each Party. For clarity, equipment and facility depreciation and other allocations of fixed assets in use to support the Development of Products are considered reasonably allocable costs and not corporate overhead. Notwithstanding the foregoing, Development Costs shall not include Development FTE costs relating to [*] including [*].

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1.35 “Development FTE” means the equivalent of a full-time individual’s work time for a twelve (12) month period on Development of Products or Collaboration Molecules. In the case that any personnel of a Party works partially on the research and Development of Products and Collaboration Molecules and other Collaboration activities related to research and Development and partially on other work outside the Collaboration in a given fiscal year, then the full-time equivalent to be attributed to such individual’s work hereunder shall be equal to the percentage of such individual’s total work time in such fiscal year that such individual spent working on activities related to the research and Development of Collaboration Molecules and Products. Development FTE efforts shall not include the work of general corporate personnel. Each Party shall track Development FTE’s using its standard practice and normal systems and methodologies.

1.36 “Development FTE Rate” means the Development FTE personnel cost incurred by a Party which shall initially be at an annual rate of [*] per Development FTE. Commencing [*], the Development FTE Rate shall be changed annually by the JSC on the first Business Day of each Calendar Year with effect for the then-current Calendar Year, by a factor equal to the rate of change for the previous Calendar Year in the Producer Price Index as published by the Bureau of Labor Statistics of the U.S. Department of Labor.

1.37 “Development Program” has the meaning set forth in Section 3.2(a).

1.38 “Diligent Efforts” means, with respect to a Party’s obligations under this Agreement to research, Develop or Commercialize a Product, the carrying out of such obligations or tasks with a level of efforts and resources consistent with the usual practice of such Party in pursuing the development or commercialization of its own pharmaceutical products that are of similar market potential as the Products, taking into account all relevant factors including product labeling or anticipated labeling, present and future market potential, past performance of Products and such Party’s own pharmaceutical products that are of similar market potential, financial return, medical and clinical considerations, present and future regulatory environment and competitive market conditions, all as measured by the facts and circumstances at the time such efforts are due. For the avoidance of doubt, in evaluating financial return to Partner, Partner shall not consider [*].

1.39 “Dimebon” means the molecule with the chemical structure set forth in Exhibit B.

1.40 “Dimebon Product” means a Product containing Dimebon.

1.41 “Distribution Costs” means those Commercialization Costs incurred by a Party or for its account, during the Term and pursuant to this Agreement that are directly and reasonably allocable to the distribution of a Product in the Shared Territory, including: (a) handling and transportation to fulfill orders with respect to a Product (but excluding such costs to the extent they are treated as a deduction in the definition of Net Sales); (b) customer services, including order entry, billing and adjustments, inquiry and credit and collection with respect to a Product; (c) reasonable and customary fees and other amounts payable to distributors; and (d) costs of storage and distribution of Products.

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1.42 “DoJ” has the meaning set forth in Section 10.6.

1.43 “Effective Date” has the meaning set forth in Section 10.6.

1.44 “EMEA” has the meaning set forth in Section 1.141.

1.45 “Europe” means all of the countries of Europe, including without limitation all of the European Union member states as of the applicable time during the Term.

1.46 “European Union” means the economic, scientific and political organization of European member states, as its membership may be altered from time to time, and any successor thereto, and which, as of the Signing Date, consists of Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, and that certain portion of Cyprus included in such organization.

1.47 “Executive Officer” means, in the case of Partner, any senior executive who reports directly to the Chief Executive Officer of Partner, and in the case of Medivation, Medivation’s Chief Executive Officer.

1.48 “Existing Confidentiality Agreement” means the Confidential Disclosure Agreement entered into by Partner and Medivation dated [*].

1.49 “FCPA” has the meaning set forth in Section 5.8(a).

1.50 “FDA” means the U.S. Food and Drug Administration or its successor.

1.51 “FD&C Act” means the U.S. Federal Food, Drug and Cosmetic Act, as amended.

1.52 “Field” means the prevention, diagnosis and treatment of all human diseases.

1.53 “Field Force Detailing Costs” means (a) with respect to Medivation, the Details conducted by Medivation Sales Representatives pursuant to the Field Force Detailing Plan multiplied by the Specialist Sales Representative Detail Cost, and (b) with respect to Partner, the Details conducted by (1) Partner’s Sales Representatives whose primary role is to Detail primary care physicians multiplied by the PCP Sales Representative Detail Cost and (2) Partner’s Sales Representatives whose primary role is to Detail Specialists or physicians and Non-Prescribers in long term care, skilled nursing facilities or assisted living facilities multiplied by the Specialist Sales Representative Detail Cost.

1.54 “Field Force Detailing Plan” has the meaning set forth in Section 5.10(d)(i).

1.55 “First Commercial Sale” means, with respect to a Product and country, the first sale to a Third Party of such Product in such country after (a) Regulatory Approval and (b) in any country in which Price Approval is necessary or relevant for a majority of the population to obtain access to pharmaceutical products, Price Approval for such Product in such country.

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1.56 “FTC” has the meaning set forth in Section 10.6.

1.57 “GCPs” means the then-current standards, practices and procedures promulgated or endorsed by the FDA for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials as set forth in the guidelines titled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA and comparable regulatory standards, practices and procedures in jurisdictions outside the U.S., as they may be updated from time to time, that provide assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

1.58 “GLPs” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable regulatory standards in jurisdictions outside the U.S., as they may be updated from time to time.

1.59 “GMPs” means the then-current good manufacturing practices required by the FDA, as defined in 21 C.F.R. Parts 210 and 211 and the regulations promulgated thereunder, for the manufacture and testing of pharmaceutical materials, and comparable laws or regulations applicable to the manufacture and testing of pharmaceutical materials in jurisdictions outside the U.S., as they may be updated from time to time. GMPs shall include applicable quality guidelines promulgated under the International Conference on Harmonization.

1.60 “Generic Product” means any pharmaceutical product that (a)(i) is sold by a Third Party that is not a licensee or Sublicensee of Partner or its Affiliates, or any of their licensees or sublicensees, under a marketing authorization granted by a Regulatory Authority to such Third Party, and (ii) contains the same Collaboration Molecule as an active pharmaceutical ingredient as the relevant Product and (b)(x) for purposes of the U.S., is approved in reliance on the prior approval of a Product as determined by the FDA, or (y) for purposes of a country outside the U.S., is approved in reliance on the prior approval of a Product as determined by the applicable Regulatory Authority.

1.61 “Governmental Authority” means any multi-national, federal, state, local, municipal or other government authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).

1.62 “HSR Act” has the meaning set forth in Section 7.9(d)(vi).

1.63 “HSR Conditions” has the meaning set forth in Section 10.6.

1.64 “Huntington’s Disease” has the meaning set forth in Section 1.71.

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1.65 “IND” means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the equivalent Regulatory Authority in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

1.66 “Indemnifying Party” has the meaning set forth in Section 11.3.

1.67 “Information” means any data, results, and information of any type whatsoever, in any tangible or intangible form, including, without limitation, know-how, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, clinical and non-clinical study reports, regulatory submission summaries and regulatory submission documents, expertise, technology, test data including pharmacological, biological, chemical, biochemical, toxicological, and clinical test data, analytical and quality control data, stability data, studies and procedures.

1.68 “Initial Approval Date” has the meaning set forth in Section 3.2(d)(ii).

1.69 “Initial Approval Studies” means the studies listed in Exhibit E hereto.

1.70 “Initial Dimebon Product” means the immediate release Dimebon Product being developed by Medivation as of the Signing Date as the candidate for initial Regulatory Approval, together with any modifications thereto that may be approved by the Parties.

1.71 “Initial Indications” means symptomatic improvement in mild-to-moderate Alzheimer’s disease, severe Alzheimer’s disease and Alzheimer’s disease related psychosis, and symptomatic improvement in Huntington’s disease (“Huntington’s Disease”).

1.72 “Initial Joint Development Plan” has the meaning set forth in Section 3.2(b).

1.73 “Initial Shared Territory Commercialization Budget” has the meaning set forth in Section 5.2.

1.74 “Initial Shared Territory Commercialization Plan” has the meaning set forth in Section 5.2.

1.75 “Joint Commercialization Committee” or “JCC” means the committee formed by the Parties as described in Section 2.6(a).

1.76 “Joint Commercialization Costs” means, with respect to a given Product and a given time period, those expenses incurred by a Party in performing its obligations under the Shared Territory Commercialization Plan and in accordance with the Shared Territory Commercialization Budget (other than with respect to Regulatory Costs as specified below) then in effect and that are directly and reasonably allocable to Commercialization (or Development

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with respect to Regulatory Costs) of such Product in the Shared Territory and incurred in accordance with an approved Shared Territory Commercialization Plan and Budget (other than with respect to Regulatory Costs as specified below), and that consist of: (a) Manufacturing Costs for the Shared Territory; (b) Sales and Marketing Costs; (c) costs associated with Medical Education Activities, and other ancillary services to the foregoing (to the extent not otherwise included in Sales and Marketing Costs); (d) Distribution Costs; (e) Third Party Payments with respect to the Shared Territory, subject to Section 7.7; (f) Trademark Costs; (g) costs of patient assistance and indigent/expanded access programs with respect to a Product in the Shared Territory; (h) import duties and similar charges for Products sold in the Shared Territory, to the extent not recovered as a Manufacturing Cost; (i) amounts written off by reason of uncollectible debts, to the extent consistent with Partner’s business practices for its other pharmaceutical products in the Shared Territory; (j) costs of developing information and data specifically intended for national accounts, managed care organizations and group purchasing organizations with respect to a Product; (k) costs of conducting advisory board meetings or other consultant programs, the purpose of which is to obtain advice and feedback related to Commercialization of a Product in the Shared Territory and (l) all Regulatory Costs for the Shared Territory incurred by a Party in performing its obligations under the Shared Territory Commercialization Plan or the Joint Development Plan. Joint Commercialization Costs shall include such Commercialization Costs which are incurred after the Effective Date and prior to the First Commercial Sale of Product in the Shared Territory (pre-launch costs). To the extent that any of the foregoing expenses apply to both the Shared Territory and the Licensed Territory, such costs shall be reasonably allocated between the Shared Territory and the Licensed Territory by unanimous decision of the JCC based on the expected benefit in the Shared Territory and the Licensed Territory as determined by the composition of the expected target audience or any other reasonable criteria determined by the JCC. Notwithstanding the foregoing, Joint Commercialization Costs shall exclude: (i) Commercialization Costs incurred solely with respect to the Licensed Territory; (ii) any Development Costs other than Regulatory Costs; (iii) income tax liabilities and corporate overhead costs of either Party; (iv) [*]; and (v) Commercialization Costs and Regulatory Costs incurred prior to the Effective Date.

1.77 “Joint Development Budget” means the budget associated with the Joint Development Plan, detailing the anticipated Joint Development Costs and approved by the JSC.

1.78 “Joint Development Committee” or “JDC” means the committee formed by the Parties as described in Section 2.3(a).

1.79 “Joint Development Costs” means all Development Costs that are directly and reasonably allocable to the Development of Products attributable to the Shared Territory and incurred in accordance with approved Joint Development Plans and Joint Development Budgets for the applicable Products. For the avoidance of doubt, Joint Development Costs shall include (a) Development FTE costs, (b) costs of CROs and other Third Parties engaged to conduct Development according to the Joint Development Plan, (c) costs of Non-Clinical Studies and Clinical Trials (including Phase 4 Clinical Trials), (d) costs of drug product or comparator drugs, (e) Manufacturing Costs incurred with respect to Development of Products for the Shared

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Territory, and (f) costs of conducting advisory board meetings or other consultant programs, the purpose of which is to obtain advice and feedback related to Development of a Product in the Shared Territory. Notwithstanding the foregoing, Joint Development Costs shall exclude: (i) Development Costs incurred solely with respect to the Licensed Territory for activities or data which will not be utilized in the Shared Territory; (ii) any Commercialization Costs; (iii) income tax liabilities and corporate overhead costs of either Party; (iv) Development Costs incurred prior to the Effective Date and (v) Regulatory Costs. For clarity, Joint Development Costs shall include one hundred percent (100%) of the costs of Non-Clinical Studies and Clinical Trials and manufacturing activities related to Development applicable for both the Shared Territory and the Licensed Territory, and Partner shall be able to use the results of those Clinical Trials in the Licensed Territory without further cost.

1.80 “Joint Development Plan” has the meaning set forth in Section 3.2(a).

1.81 “Joint Inventions” has the meaning set forth in Section 9.1.

1.82 “Joint Manufacturing Budget” has the meaning set forth in Section 6.2(b).

1.83 “Joint Manufacturing Plan” has the meaning set forth in Section 6.1.

1.84 “Joint Manufacturing Committee” or “JMC” means the committee formed by the Parties as described in Section 2.5(a).

1.85 “Joint Patent” has the meaning set forth in Section 9.3(c).

1.86 “Joint Regulatory Committee” or “JRC” means the committee formed by the Parties as described in Section 2.4(a).

1.87 “Joint Steering Committee” or “JSC” means the committee formed by the Parties as described in Section 2.2(a).

1.88 “Key Markets” means [*].

1.89 “Launch Product Volume” has the meaning set forth in Section 6.3(b).

1.90 “Launch Product Volume Criteria” has the meaning set forth in Section 6.3(b).

1.91 “Licensed Territory” means all countries of the world other than the Shared Territory.

1.92 “Manufacturing Costs” means costs of manufacturing a Product which Product is either: (a) supplied to a Party by a Third Party; or (b) manufactured directly by a Party or its Affiliate, in each case to the extent such costs are directly and reasonably allocable to the Development or Commercialization of a Product in the Territory, as further described below and in accordance with generally accepted accounting principles in the U.S. (“US GAAP”).

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Manufacturing Costs shall be included in Joint Commercialization Costs on a “cost of sales” basis as Product is sold, or Joint Development Costs on a usage basis as clinical supplies are used, as the case may be, in each case via standard costs and reconciliation for variances to standard cost and inventory write-offs. In the event that a Party performs any of its manufacturing and supply obligations through one or more Affiliates, any inter-company amounts or fees paid for any such services or Product or any intermediate used therein by such Party shall not be included in calculating Manufacturing Costs and only those costs directly incurred by such Affiliate shall be so included.

For costs in subsection (a), Manufacturing Costs means: (i) the amount paid to such a Third Party (excluding any Third Party Payments); plus (ii) the relevant manufacturing Party’s reasonable direct and identifiable internal costs and out-of-pocket costs, incurred or accrued (including any prepayments) by the manufacturing Party in connection with inventory write-offs, variances, manufacturing process improvements, storage, freight, manufacturing scale-up, manufacturing site qualification, materials, quality assurance and quality control (including testing), supply chain management, capital equipment, similar activities comprising the manufacturing Party’s oversight of the manufacturing process of the Third Party, and any value-added tax or similar tax due for amounts paid to such Third Party, but excluding costs otherwise included within Development Costs.

For costs in subsection (b), Manufacturing Costs means the “standard cost” per unit, including variances to standard costs and inventory write-offs. This standard cost shall include the cost of materials, labor, and other direct and identifiable variable costs incurred or accrued by the manufacturing Party in connection with the manufacture of a Product, manufacturing process improvements, storage, freight, manufacturing scale-up, manufacturing site qualification, quality assurance and quality control (including testing), supply chain management, and costs of equipment, plant operations and plant support services necessary to produce a Product, but excluding costs otherwise included within Development Costs. These costs of plant operations and support services shall include utilities, maintenance, engineering, safety, human resources, finance, plant management and other similar activities, including idle plant capacity reserved specifically for the Product based on anticipated Product volumes in the ensuing [*] months. Costs that cannot be identified to a specific activity supporting manufacturing of a Product, such as charges for corporate overhead or excess capacity not specifically reserved for the Product as described above, shall be excluded from the determination of Manufacturing Costs.

Subject to the preceding paragraph, “standard cost” per unit for purposes of ongoing cost accounting purposes shall be calculated in accordance with Partner’s then-current standard cost manual that is applied consistently to all pharmaceutical products sold by Partner. The Parties shall reconcile the standard cost charges, and appropriate credits or payments from one Party to the other shall be made to effect such reconciliation not less than [*] against the above Manufacturing Cost definition.

Manufacturing Costs shall include costs of such activities that are undertaken at any time during the Term of this Agreement (including manufacturing activities relating to the Commercialization of a Product that are undertaken prior to the initial Regulatory Approval of such Product).

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1.93 “Marketing Authorization Application” or “MAA” means an application for Regulatory Approval in a country, territory or possession other than the Shared Territory.

1.94 “Marks” has the meaning set forth in Section 9.9.

1.95 “Materials” means all tangible compositions of matter, devices, articles of manufacture, assays, biological, chemical or physical materials and other similar materials, but excluding tangible Commercialization materials such as advertising and promotional materials and sales force materials.

1.96 “Medical Education Activities” means activities designed to ensure or improve appropriate medical use of, conduct medical education of, or further research regarding, a Product sold in the Shared Territory, including by way of example: (a) activities of medical scientific liaisons who (x) conduct service-based medical activities including providing input and assistance with consultancy meetings, recommend investigators for clinical trials and provide input in the design of such trials and other research related activities, and (y) deliver non-promotional communications and conduct non-promotional activities including responding to enquiries of medical professionals for off-label information and presenting new clinical trial and other scientific information; (b) grants to support continuing medical education, symposia, or third party research related to a Product in the Shared Territory; and (c) development, publication and dissemination of publications relating to a Product in the Shared Territory, as well as medical information services provided in response to inquiries communicated via Sales Representatives or received by letter, phone call or email.

1.97 “Medivation Claims” has the meaning set forth in Section 11.2.

1.98 “Medivation Damages” has the meaning set forth in Section 11.2.

1.99 “Medivation Detail Requirement” means the Specialty Detail Effort multiplied by the Medivation Promotional Share.

1.100 “Medivation Indemnitees” has the meaning set forth in Section 11.2.

1.101 “Medivation Know-How” means all Information Controlled as of the Effective Date or thereafter during the Term by Medivation and/or its Affiliate(s) and reasonably necessary or useful for the research, development, manufacture, use, importation or sale of Collaboration Molecules or Products in the Field; including, without limitation, any such Information made or generated by or on behalf of Medivation or its Affiliate in the course of performing Medivation’s obligations or exercising Medivation’s rights under this Agreement. For clarity, the use of “Affiliate” in this definition shall exclude any Third Party that becomes an Affiliate due to such Third Party’s acquisition of Medivation, except as provided in Section 15.5. For additional clarity, Medivation Know-How shall exclude rights under any Medivation Patents and Medivation’s interests in Joint Patents and Joint Inventions.

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

1.102 “Medivation Patents” means all patents and patent applications that are Controlled as of the Effective Date or thereafter during the Term by Medivation and/or its Affiliate(s) and that claim the composition of matter, manufacture or use of one or more Collaboration Molecules or Products or that would otherwise be infringed, absent a license, by the manufacture, use or sale of any Collaboration Molecule or Product. For clarity, the use of “Affiliate” in this definition shall exclude any Third Party that becomes an Affiliate due to such Third Party’s acquisition of Medivation except as provided in Section 15.5. For additional clarity, Medivation Patents shall exclude the Joint Patents.

1.103 “Medivation Sales Force” has the meaning set forth in Section 5.11(e)(i).

1.104 “Medivation Sales Force Trainers” has the meaning set forth in Section 5.11(e)(i).

1.105 “Medivation Sales Representatives” has the meaning set forth in Section 5.11(e)(i).

1.106 “Medivation Technology” means the Medivation Patents, Medivation Know-How, and Medivation’s interest in Joint Patents and Joint Inventions.

1.107 “MHLW” has the meaning set forth in Section 1.141.

1.108 “MMA” has the meaning set forth in Section 5.11(j)(ii).

1.109 “NDA” means a New Drug Application, as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA.

1.110 “Net Sales” means, with respect to any Product, the gross amount invoiced by Partner, any Affiliate, or Sublicensee for sales of such Product to a Third Party less deductions for:

(a) transportation charges, and other charges, such as insurance, relating thereto,

(b) sales and excise taxes or customs duties paid by the selling party and any other governmental charges imposed upon the sale of such Product and actually paid,

(c) allowances actually granted or allowed,

(d) quantity discounts, cash or other discounts (e.g., early payment) or chargebacks actually granted, allowed or incurred in the ordinary course of business in connection with the sale of the such Product,

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

(e) allowances or credits to customers actually given and not in excess of the selling price of such Product, on account of rejection, outdating recalls or return of such Product, and

(f) discounts, rebates, reimbursements, fees or similar payments to wholesalers and other distributors, buying groups, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations, Governmental Authorities, or other institutions or health care organizations or arising in connection with any Pfizer Discount or Savings Program (as defined below).

For purposes of this definition of “Net Sales” only, “Pfizer Discount or Savings Program” means any discount, rebate or reimbursement program applicable to a Product under which Partner or its Affiliates provides to low income, uninsured or other patients the opportunity to purchase Pfizer pharmaceutical products at discounted prices.

The calculation of Net Sales will involve the use of estimates for certain deductions above. Those estimates will be accrued and Net Sales trued-up at least quarterly to actual in accordance with US GAAP and Partner’s internal accounting policies, as consistently applied.

Sales between Partner and its Affiliates and Sublicensees shall be disregarded for purposes of calculating Net Sales except if such purchaser is an end user.

In the case of the Licensed Territory, if a Product either (i) is sold in the form of a combination product containing both a Collaboration Molecule and one or more independently therapeutically active pharmaceutical molecules (i.e. a chemical entity performing a therapeutic or prophylactic function distinct from the enhancement of the activity or bioavailability of the Collaboration Molecule itself) that are not Collaboration Molecules or (ii) is sold in a form that contains (or is sold bundled with) a delivery device therefor (in either case of (i) or (ii), a “Combination Product”), the Net Sales of such Product for the purpose of calculating royalties owed under this Agreement for sales of such Product, shall be determined as follows: first, Partner shall determine the actual Net Sales of such Combination Product (using the above provisions) and then such amount shall be multiplied by the fraction A/(A+B), where A is the invoice price of the Product, if sold separately, and B is the total invoice price of any other active pharmaceutical molecule or delivery device in the combination if sold separately. If any other active pharmaceutical molecule or delivery device in the combination is not sold separately, Net Sales shall be calculated by multiplying actual Net Sales of such Combination Product by a fraction A/C where A is the invoice price of the Product if sold separately, and C is the invoice price of the Combination Product. If neither the Product nor any other active pharmaceutical molecule or delivery device in the Combination Product is sold separately, the adjustment to Net Sales shall be determined by the Parties in good faith to reasonably reflect the fair market value of the contribution of the Product in the Combination Product to the total fair market value of such Combination Product.

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

In the case of Combination Products sold in the Shared Territory, Net Sales shall be calculated [*] (i.e., Net Sales shall include [*], and the [*] with [*] or [*] shall be included as [*].

With respect to any sale of any Product in a given country for any substantive consideration other than monetary consideration on arm’s length terms (which has the effect of reducing the invoiced amount below what it would have been in the absence of such non-monetary consideration), for purposes of calculating the Net Sales under this Agreement, such Product shall be deemed to be sold exclusively for cash at the average Net Sales price charged to Third Parties for cash sales in such country during the applicable reporting period (or if there were only de minimus cash sales in such country, at the fair market value as determined by comparable markets). Notwithstanding the foregoing, Net Sales shall not include amounts (whether actually existing or deemed to exist for purposes of calculation) for Products distributed for use in Clinical Trials or for promotional purposes.

Net Sales shall be determined in accordance with US GAAP principles regularly employed by Partner, its Affiliate(s), and/or Sublicensees (as applicable) with respect to the transactions in question.

1.111 “Non-Clinical Studies” means all non-human studies of Collaboration Molecules and Products.

1.112 “Non-Prescriber” has the meaning set forth in Section 1.151.

1.113 “OIG” has the meaning set forth in Section 5.11(j)(i).

1.114 “Operating Profit (or Loss)” means, for a given period of time, Net Sales of Products in the Shared Territory during such period, less the sum of (a) Joint Commercialization Costs and (b) Joint Development Costs incurred during such time period. For sake of clarity, Operating Profit (or Loss) shall be determined prior to application of any income taxes, and if such terms are used individually, “Operating Profit” shall mean a positive Operating Profit (or Loss), and “Operating Loss” shall mean a negative Operating Profit (or Loss).

1.115 “Other Indications” means an indication in the Field other than the Initial Indications.

1.116 “Other Patented Molecule” means any molecule other than Dimebon, the use of which for the treatment of neurodegenerative diseases would be covered by [*].

1.117 “Partner CIA” has the meaning set forth in Section 5.11(j)(i).

1.118 “Partner Claims” has the meaning set forth in Section 11.1.

1.119 “Partner Damages” has the meaning set forth in Section 11.1.

1.120 “Partner Indemnitees” has the meaning set forth in Section 11.1.

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

1.121 “Partner Know-How” means all Information Controlled as of the Effective Date or thereafter during the Term by Partner and/or its Affiliate(s) that is reasonably necessary or useful for the research, development, manufacture, use, importation or sale of Products in the Field; including, without limitation, any such Information made or generated by or on behalf of Partner or its Affiliate(s) or Sublicensee(s) in the course of performing Partner’s obligations or exercising Partner’s rights under this Agreement. For clarity, the use of “Affiliate” in this definition shall exclude any Third Party that becomes an Affiliate due to such Third Party’s acquisition of, or by, Partner, except as provided in Section 15.5. For additional clarity, Partner Know-How shall exclude rights under any Partner Patents and Partner’s interests in Joint Patents and Joint Inventions.

1.122 “Partner Patents” means all patents and patent applications that are Controlled as of the Effective Date or thereafter during the Term by Partner and/or its Affiliate(s) and that claim the composition of matter, manufacture or use of one or more Collaboration Molecules or Products or that would otherwise be infringed, absent a license, by the manufacture, use or sale of any Collaboration Molecule or Product. For clarity, the use of “Affiliate” in this definition shall exclude any Third Party that becomes an Affiliate due to such Third Party’s acquisition of, or by, Partner except as provided in Section 15.5. For further clarity, Partner Patents shall exclude the Joint Patents.

1.123 “Partner Quarter” means each of the four (4) thirteen (13) week periods (a) with respect to the U.S., commencing on January 1 of any Calendar Year, and (b) with respect to any country in the Territory other than the U.S., commencing on December 1 of any Calendar Year.

1.124 “Partner Technology” means the Partner Patents, Partner Know-How, and Partner’s interest in Joint Patents and Joint Inventions.

1.125 “Partner Year” means the twelve (12) month period (a) with respect to the U.S., commencing on January 1 of any Calendar Year, and (b) with respect to any country in the Territory other than the U.S., commencing on December 1 of any Calendar Year.

1.126 “Partner Withholding Tax Action” has the meaning set forth in Section 8.7(c).

1.127 “PCP Sales Representative Detail Cost” means commencing with the Effective Date, [*] per Detail in the U.S. to a [*] conducted by a Party’s Sales Representative whose primary responsibility is to Detail [*]. Throughout the [*], the PCP Sales Representative Detail Cost for the previous Calendar Year shall be amended on the first Business Day of each Calendar Year with effect for the then-current Calendar Year, by a factor equal to the rate of change for the previous Calendar Year in the Producer Price Index as published by the Bureau of Labor Statistics of the U.S. Department of Labor.

1.128 “PDM Act” has the meaning set forth in Section 5.11(j)(i).

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

1.129 “Phase 4 Clinical Trial” means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

1.130 “PhRMA” has the meaning set forth in Section 5.11(j)(i).

1.131 “PhRMA Code” has the meaning set forth in Section 5.11(j)(i).

1.132 “PMDA” has the meaning set forth in Section 1.141.

1.133 “Pre-Launch Manufacturing and CMC Development Cost Cap” means the maximum amount that Partner will seek to recover from Medivation for Medivation’s share (i.e., 40%) of the total aggregate annual budget for Manufacturing conducted by Partner with respect to Development of, and CMC Development activities (including Development FTEs for CMC Development but excluding the cost of pharmaceutical products other than Products used in Clinical Trials) conducted by Partner for, the Initial Dimebon Product prior to the First Commercial Sale of such Product as described in Exhibit C attached hereto.

1.134 “Price Approval” means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

1.135 “Product” means any pharmaceutical product, including all forms, presentations, doses and formulations, containing a Collaboration Molecule alone or in combination with other therapeutically active ingredients; it being understood that all pharmaceutical products that contain the same Collaboration Molecule shall be considered the same Product.

1.136 “Product Infringement” has the meaning set forth in Section 9.4(a).

1.137 “Promotional Materials” means all Sales Representative training materials and all written, printed, graphic, electronic, audio or video matter, including, without limitation, journal advertisements, sales visual aids, leave behind items, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings, internet sites, broadcast advertisements and sales reminder aides (for example, note pads, pens and other such items) intended for use or used by either Party or its Affiliates or Sublicensees in connection with any promotion of a Co-Promotion Product.

1.138 “Publication” has the meaning set forth in Section 12.4.

1.139 “[*]” means an [*] product that is [*] to the Initial Dimebon Product, as determined by the JDC.

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

1.140 “Regulatory Approval” means all approvals necessary for the manufacture, marketing, importation and sale of a Product for one or more indications in the Field and in a country or regulatory jurisdiction, which may include, without limitation, satisfaction of all applicable regulatory and notification requirements, but which shall exclude Price Approval.

1.141 “Regulatory Authority” means, in a particular country or regulatory jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval and/or, to the extent required in such country or regulatory jurisdiction, pricing or reimbursement approval of a Product in such country or regulatory jurisdiction, including without limitation, (a) the FDA, (b) the European Medicines Agency (“EMEA”), (c) the European Commission, and (d) Japanese Ministry of Health, Labour and Welfare (“MHLW”), (e) Japanese Pharmaceuticals and Medical Devices Agency (“PMDA”) and in each of (a) through (e), including any successor thereto.

1.142 “Regulatory Costs” means costs incurred to prepare Product regulatory submissions to obtain and/or maintain Regulatory Approval and to comply with post-Regulatory Approvals requirements of a Regulatory Authority, including FDA user and other fees, reporting and regulatory affairs activities, and recalls and withdrawals for Products (other than costs for Products that are deductible from Net Sales or that are included as Development Costs).

1.143 “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a Product other than patents, including, without limitation, rights conferred in the U.S. under the Hatch-Waxman Act or the FDA Modernization Act of 1997 (including pediatric exclusivity), or rights similar thereto outside the U.S.

1.144 “Regulatory Issue” means any matter involving interaction with a Regulatory Authority or compliance with regulatory requirements.

1.145 “Regulatory Materials” means regulatory applications, submissions, notifications, correspondences, registrations, Regulatory Approvals and/or other filings made to or with, or other approvals granted by, a Regulatory Authority that are necessary or reasonably desirable in order to Develop, manufacture, market, sell or otherwise Commercialize a Product in a particular country or regulatory jurisdiction. Regulatory Materials include, without limitation, INDs, MAAs, and NDAs.

1.146 “Restricted Product” has the meaning set forth in Section 7.9(b).

1.147 “Reverted Partner Know-How” means Partner Know-How excluding any Partner Know-How directed to (i) [*], or (ii) [*] in a [*], alone or in combination with each other or with Dimebon.

1.148 “Reverted Partner Patents” means Partner Patents excluding any claims therein that cover or claim (i) [*], or (ii) [*] in a [*], alone or in combination with each other or with Dimebon.

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

1.149 “Royalty Term” has the meaning set forth in Section 8.5(c).

1.150 “Sales and Marketing Costs” means (1) the out-of-pocket costs that are directly and reasonably allocable to the sales and marketing of a Product in the Shared Territory and that are compliant with Applicable Laws and applicable guidelines concerning the advertising, sales and marketing of prescription drug products (e.g. PhRMA Code), including: (a) activities directed to the advertising and marketing of a Product; (b) professional education in the Shared Territory for U.S.-based professionals (to the extent not performed by Sales Representatives), including launch meetings; (c) costs of advertising, public relations and medical education agencies with respect to a Product; (d) peer-to-peer activities with respect to a Product, such as grand rounds, and lunch and dinner meetings; (e) speaker programs with respect to a Product, including the training of such speakers; (f) developing and providing training packages, promotional literature, Samples, Promotional Materials and other selling materials with respect to a Product; (g) developing and performing market research with respect to a Product and developing branding, communications and life cycle management plans; (h) conducting symposia and opinion leader development activities with respect to a Product; (i) developing reimbursement programs with respect to a Product; and (j) e-details or detailing through video and (2) subject to Section 5.10(d), Field Force Detailing Costs.

1.151 “Sales Call” means a personal visit by a Sales Representative to (a) one or several medical professional(s) having prescribing authority in the part of the Field for the indications in which such Product is approved, as well as (b) other individuals or entities that have significant impact or influence on prescribing decisions in the part of the Field in which such Product is approved (“Non-Prescribers”), including retail pharmacists, and ancillary staff in long term care, skilled nursing facilities or assisted living facilities such as clinical pharmacists, DONs, and CNAs but not staff in community physician offices.

1.152 “Safe Harbor Regulations” has the meaning set forth in Section 5.11(j)(i).

1.153 “Safety Risk” means, with respect to a Clinical Trial anywhere in the Territory, [*], the design of or possible results of such Clinical Trial, based on the [*] in a [*] or in a [*] with a [*], possesses a [*] safety risk.

1.154 “Sales Representative” means a pharmaceutical sales representative employed by either Party to conduct Detailing and other promotional efforts with respect to the Products in accordance with the terms of this Agreement.

1.155 “Samples” means Product packaged and distributed as a complimentary trial for use with patients in the U.S. and in accordance with the PDM Act and free goods provided for this purpose through coupons or other mechanisms.

1.156 “SEC” means the U.S. Securities and Exchange Commission.

1.157 “Shared Territory” means the U.S.

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

1.158 “Shared Territory Commercialization Budget” has the meaning set forth in Section 5.2.

1.159 “Shared Territory Commercialization Plan” has the meaning set forth in Section 5.2.

1.160 “Sole Inventions” has the meaning set forth in Section 9.1.

1.161 “Specialist” means neurologists and psychiatrists.

1.162 “Specialist Sales Representative Detail Cost” means commencing with the Effective Date, [*] per Detail in the U.S. to a [*] conducted by a Party’s Sales Representative whose primary responsibility is to Detail [*] in [*]. Throughout the [*], the Specialist Sales Representative Detail Cost for the previous Calendar Year shall be amended on the first Business Day of each Calendar Year with effect for the then-current Calendar Year, by a factor equal to the rate of change for the previous Calendar Year in the Producer Price Index as published by the Bureau of Labor Statistics of the U.S. Department of Labor.

1.163 “Specialty Detail Effort” means the annual aggregate number of Details to be provided by Partner and Medivation under the applicable Field Force Detailing Plan to Specialists in the Shared Territory for the purpose of promoting a Co-Promotion Product.

1.164 “Standstill Period” has the meaning set forth in Section 15.6(a).

1.165 “Standstill Provisions” has the meaning set forth in Section 15.6(c).

1.166 “Sublicense or Subcontractor Agreement” has the meaning set forth in Section 7.4(b).

1.167 “Sublicensee” means any Third Party granted a sublicense by a Party to the rights licensed to such Party pursuant to Article 7 hereof.

1.168 “Target” has the meaning set forth in Section 15.5.

1.169 “Tax” means any tax (including any income tax, franchise tax, capital gains tax, gross receipts tax, value-added tax, surtax, excise tax, ad valorem tax, transfer tax, stamp tax, sales tax, use tax, property tax, business tax, withholding tax or payroll tax), levy, assessment, tariff, duty (including any customs duty), deficiency or fee, and any related charge or amount (including any fine, addition, penalty or interest), imposed, assessed or collected by any Governmental Authority.

1.170 “Term” has the meaning set forth in Section 13.1.

1.171 “Territory” means all countries in the world.

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

1.172 “Third Party” means any entity other than Medivation or Partner or an Affiliate of either of them.

1.173 “Third Party Licenses” means those license agreements entered into, or to be entered into, by and between a Party or its Affiliate, on the one hand, and a Third Party on the other hand, to license intellectual property of the Third Party that is determined to be necessary or useful for the research, Development, manufacture, distribution, advertising or marketing, use, sale, offer to sell or importation of any Compound Molecule or Product.

1.174 “Third Party Payment” has the meaning set forth in Section 7.7.

1.175 “Trademark Costs” mean those Commercialization Costs incurred for outside counsel and other Third Parties, and filing and maintenance expenses, in each case incurred in connection with the establishment and maintenance of rights under trademarks applicable to Product in the Shared Territory, including costs of Shared Territory trademark filing and registration fees, actions to enforce or maintain a Shared Territory trademark and other Shared Territory trademark proceedings.

1.176 “Training Program” has the meaning set forth in Section 5.11(g)(i).

1.177 “Trigger Event” has the meaning set forth in Section 15.6(d).

1.178 “U.S.” means the United States of America (including all possessions and territories thereof).

1.179 “US GAAP” has the meaning set forth in Section 1.92.

1.180 “Valid Claim” means (a) a claim (including a process, use, or composition of matter claim) of an issued and unexpired patent, which has not been held invalid or unenforceable by a patent office, court or other governmental agency or an intergovernmental agency of competent jurisdiction, which holding is unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid by the owner through reissue, disclaimer or otherwise and (b) a claim (including a process, use, or composition of matter claim) within a patent application that is pending for less than [*] years from its the earliest priority date and that has not been revoked, cancelled, withdrawn, or affirmatively abandoned, or held invalid, unenforceable, unpatentable, or abandoned by a patent office, court or other governmental agency or an intergovernmental agency of competent jurisdiction, which holding is unappealable or unappealed within the time allowed for appeal.

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

ARTICLE 2

COLLABORATION; GOVERNANCE

2.1 Collaboration Overview. The Parties desire and intend to collaborate with respect to the Development of Products in the Field in the Territory, and Commercialization of Products in the Field in the Shared Territory, as and to the extent set forth in this Agreement (the “Collaboration”). It is intended that the Collaboration utilize Partner’s position as a large, fully-integrated pharmaceutical company, while recognizing Medivation’s current experience and expertise in, and aspirations to further develop its clinical development and commercialization capabilities with respect to, biopharmaceuticals.

2.2 Joint Steering Committee.

(a) Purpose; Formation. The Parties hereby establish a joint steering committee (the “JSC”) that will monitor and oversee the activities under this Agreement and facilitate communications between the Parties with respect to the Development and Commercialization of Products, all in accordance with this Section 2.2.

(b) Composition. Each Party shall initially appoint three (3) representatives to the JSC, each of whom will have sufficient seniority within the applicable Party to make decisions arising within the scope of the JSC’s responsibilities. The Parties’ initial representatives to the JSC are set forth on Exhibit D. The JSC may change its size from time to time by mutual consent of its members, provided that the JSC shall at all times consist of an equal number of representatives of each of Medivation and Partner. Each Party may replace its JSC representatives at any time upon written notice to the other Party; provided, however, that replacement of any JSC representative with an individual with lower seniority (as determined by such individual’s role within a Party’s organization and not by his/her title) shall require approval of the other Party which approval shall not be unreasonably withheld. The JSC may invite non-members (including consultants and advisors of a Party who are under an obligation of confidentiality consistent with this Agreement) to participate in the discussions and meetings of the JSC, provided that such participants are involved in activities related to Collaboration Molecule or Products and shall have no voting authority at the JSC. The JSC shall have a chairperson, who shall serve for a term of one year, and who shall be selected alternately, on an annual basis, by Medivation or Partner. The initial chairperson shall be selected by Partner. The role of the chairperson shall be to convene and preside at meetings of the JSC, to prepare and circulate agendas and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JSC representatives.

(c) Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JSC shall in particular:

(i) oversee the collaborative activities of the Parties under this Agreement;

(ii) receive and discuss reports from the JDC, JMC, JRC and JCC and provide guidance thereto, and subject to Section 5.3, approve the Shared Territory Commercialization Plan and Shared Territory Commercialization Budget, the Joint Development Plan and Joint Development Budget, and the Joint Manufacturing Plan and Joint Manufacturing Budget, and in each case, any amendments thereto;

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

(iii) review strategies for obtaining, maintaining, defending and enforcing trademark protection for Products within the Territory;

(iv) attempt to resolve issues presented to it by, and disputes within, the JDC, JMC, JCC, JRC, or any other subcommittee;

(v) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and

(vi) perform such other functions as appropriate to further the purposes of this Agreement as allocated to it in writing by the Parties or as specified in the Agreement in Sections 5.5, 7.7, 8.2 and 9.3(d).

(d) Meetings. The Parties shall endeavor to have their first meeting of the JSC within [*] days after the Effective Date. The JSC shall meet at least [*] per [*] during the Term spaced at regular intervals unless the Parties mutually agree in writing to a different frequency for such meetings. Either Party may also call a special meeting of the JSC (by videoconference or teleconference) by at least [*] Business Days prior written notice to the other Party in the event such Party reasonably believes that a significant matter must be addressed prior to the next scheduled meeting, and such Party shall provide the JSC no later than [*] Business Days prior to the special meeting with materials reasonably adequate to enable an informed decision; provided that for time sensitive matters, a Party may call a special meeting of the JSC with less than [*] Business Days notice if the Parties agree that an issue warrants an expedited meeting. No later than [*] Business Days prior to any meeting of the JSC, the chairperson of the JSC shall prepare and circulate an agenda for such meeting; provided, however, that either Party may propose additional topics to be included on such agenda, either prior to or in the course of such meeting. The JSC may meet in person, by videoconference or by teleconference. Notwithstanding the foregoing, at least [*] meeting per [*] shall be in person unless the Parties mutually agree in writing to waive such requirement in lieu of a videoconference or teleconference. In-person JSC meetings will be held at locations in the U.S. alternately selected by Medivation and by Partner. Each Party will bear the expense of its respective JSC members’ participation in JSC meetings. Meetings of the JSC shall be effective only if at least one (1) representative of each Party is present or participating in such meeting. The chairperson of the JSC will be responsible for preparing reasonably detailed written minutes of all JSC meetings that reflect, without limitation, material decisions made at such meetings. The JSC chairperson shall send draft meeting minutes to each member of the JSC for review and approval within [*] Business Days after each JSC meeting. Such minutes will be deemed approved unless one or more members of the JSC objects to the accuracy of such minutes within [*] Business Days of receipt.

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(e) Decision-Making. In addition to resolving issues specifically delegated to it, the JSC shall have the authority to resolve any disputes within the Collaboration not resolved by the JDC, JMC, JCC, or JRC, except where expressly specified elsewhere in this Agreement. The representatives from each Party will have, collectively, one (1) vote on behalf of that Party, and all decision making shall be by consensus to the extent feasible. If the JSC is unable to reach consensus on any issue for which it is responsible, such issue shall be resolved in accordance with Section 2.7(b).

2.3 Joint Development Committee.

(a) Formation; Composition. Within [*] days after the Effective Date, the Parties shall establish a committee to oversee Development of Product(s) in the Territory in accordance with the Joint Development Plan(s) for such Product(s) and to coordinate the Development activities of the Parties (the “JDC”), provided that primary responsibility for coordinating CMC Development shall be with the JMC. Each Party shall initially appoint three (3) representatives to the JDC, with each representative having knowledge and expertise in the development of products similar to the Products and having sufficient seniority within the applicable Party to make decisions arising with the scope of the JDC’s responsibilities. The JDC may change its size from time to time by mutual consent of its members, provided that the JDC shall consist at all times of an equal number of representatives of each of Medivation and Partner. Each Party may replace its JDC representatives at any time upon written notice to the other Party. The JDC may invite non-members (including consultants and advisors of a Party who are under an obligation of confidentiality consistent with this Agreement) to participate in the discussions and meetings of the JDC, provided that such participants are involved in activities related to Collaboration Molecule or Products and shall have no voting authority at the JDC. The JDC shall have a chairperson, who shall serve for a term of one year, and who shall be selected alternately, on an annual basis, by Medivation or Partner. The initial chairperson shall be selected by Medivation. The role of the chairperson shall be to convene and preside at meetings of the JDC, to prepare and circulate agendas and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JDC representatives.

(b) Specific Responsibilities of the JDC. In addition to its general responsibilities, the JDC shall in particular:

(i) discuss, prepare and approve for submission to the JSC annual and interim amendments to the Joint Development Plan and Joint Development Budget for each Product;

(ii) oversee the conduct of the Development Program;

(iii) review and modify the Development FTE Rate used to calculate Joint Development Costs;

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(iv) review and update monthly financial forecasts to ensure actual and anticipated spend is within the approved Joint Development Budget;

(v) create, implement and review the overall strategy for Development and the design and objectives of all Clinical Trials and Non-Clinical Studies conducted under each Joint Development Plan (other than investigator initiated Clinical Trials and Phase 4 Clinical Trials). For the Initial Approval Studies that have not been initiated and Non-Clinical Studies and Clinical Trials that are not included in the Initial Development Plan, the JDC will form a joint development working group for each study with members from each Party (as designated by such Party) that will prepare and make recommendations on study design (including objectives, study endpoints, population, sample size, duration and statistical analysis plan) and the execution of such studies to the JDC and the JDC will review and approve the final study design and protocols for such studies.

(vi) decide whether and when to initiate or discontinue, and oversee the conduct of, any Clinical Trial and any Non-Clinical Study under each Joint Development Plan;

(vii) allocate budgeted resources (to the extent applicable) and determine priorities for each Clinical Trial and Non-Clinical Study under each Joint Development Plan, other than Phase 4 Clinical Trials and any investigator-initiated Clinical Trials;

(viii) facilitate the flow of Information between the Parties with respect to Development of Collaboration Molecules and Product in the Territory;

(ix) discuss and decide whether to Develop (x) Products (other than the Initial Dimebon Product) and for which indications and (y) the Initial Dimebon Product for Other Indications;

(x) allocate primary responsibility as between the Parties for tasks relating to Development of Collaboration Molecules and Products where not already specified in the Joint Development Plan; and

(xi) perform such other functions as may be appropriate to further the purposes of this Agreement, as directed by the JSC or as specified in this Agreement pursuant to Sections 1.139, 3.2(b) and 8.2(a)(i).

(c) Meetings. During the period prior to [*], the JDC shall meet at least [*] per [*], spaced at regular intervals unless the Parties mutually agree in writing to a different frequency. Thereafter, the JDC shall meet at least [*] per [*], spaced at regular intervals unless the Parties mutually agree in writing to a different frequency. Following the Initial Approval Date, either Party may also call a special meeting of the JDC (by videoconference or teleconference) by at least [*] Business Days prior written notice to the other Party in the event such Party reasonably believes that a significant matter must be addressed prior to the next

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scheduled meeting, and such Party shall provide the JDC no later than [*] Business Days prior to the special meeting with materials reasonably adequate to enable an informed decision; provided that for time sensitive matters, a Party may call a special meeting of the JDC with less than then [*] Business Days notice if the Parties agree that an issue warrants an expedited meeting. No later than [*] Business Days prior to any meeting of the JDC, the chairperson of the JDC shall prepare and circulate an agenda for such meeting; provided, however, that either Party shall be free to propose additional topics to be included on such agenda, either prior to or in the course of such meeting. The JDC may meet in person, or at the request of either Party, by videoconference or by teleconference. In-person JDC meetings will be held at locations in the U.S. alternately selected by Medivation and by Partner. Each Party shall report to the JDC on all material issues relating to the Development of Products for and in the Territory at the JDC meeting occurring after such issues arise. Each Party will bear the expense of its respective JDC members’ participation in JDC meetings. Meetings of the JDC shall be effective only if at least one (1) representative of each Party is present or participating in such meeting. The chairperson of the JDC shall be responsible for keeping reasonably detailed written minutes of all JDC meetings that reflect all decisions made at such meetings. The JDC chairperson shall send meeting minutes to each member of the JDC for review and approval within [*] Business Days after each JDC meeting. Minutes will be deemed approved unless one or more members of the JDC objects to the accuracy of such minutes within [*] Business Days of receipt.

(d) Decision-Making. Subject to the remainder of this Section 2.3(d) and Section 2.7, the JDC shall act by consensus. The representatives from each Party will have, collectively, one (1) vote on behalf of that Party. If the JDC cannot reach consensus on an issue that comes before the JDC and over which the JDC has oversight, then such matter shall be resolved in accordance with Section 2.7(a).

2.4 Joint Regulatory Committee.

(a) Formation; Composition. Within [*] days after the Effective Date, the Parties shall establish a committee to oversee and manage the Regulatory Approval of Product(s) in the Territory in accordance with the Joint Development Plan(s) for such Product(s) and to coordinate the regulatory activities of the Parties (the “JRC”). Each Party shall initially appoint three (3) representatives to the JRC, with each representative having knowledge and expertise in obtaining and maintaining Regulatory Approvals of products similar to the Products and having sufficient seniority within the applicable Party to make decisions arising with the scope of the JRC’s responsibilities. The JRC may change its size from time to time by mutual consent of its members, provided that the JRC shall consist at all times of an equal number of representatives of each of Medivation and Partner. Each Party may replace its JRC representatives at any time upon written notice to the other Party. The JRC may invite non-members (including consultants and advisors of a Party who are under an obligation of confidentiality consistent with this Agreement) to participate in the discussions and meetings of the JRC, provided that such participants are involved in activities related to Collaboration Molecules or Products and shall have no voting authority at the JRC. The JRC shall have a chairperson, who shall serve for a term of one year, and who shall be selected alternately, on an annual basis, by Medivation or

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Partner. The initial chairperson shall be selected by Medivation. The role of the chairperson shall be to convene and preside at meetings of the JRC, to prepare and circulate agendas and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JRC representatives.

(b) Specific Responsibilities of the JRC. In addition to its general responsibilities, the JRC shall in particular:

(i) discuss the requirements for Regulatory Approval in the Territory and oversee and coordinate regulatory matters with respect to Products in the Territory;

(ii) facilitate the flow of Information between the Parties with respect to obtaining Regulatory Approval for Products;

(iii) discuss and manage (along with the JMC) CMC related activities and responses to FDA queries;

(iv) coordinate the preparation for submission of the NDA and MAAs for Products;

(v) manage the transfer of the NDA and INDs for the Initial Dimebon Product to Partner after the Initial Approval Date; and

(vi) perform such other functions as may be appropriate to further the purposes of this Agreement, as directed by the JSC.

(c) Meetings. During the period prior to [*], the JRC shall meet at least [*] per [*], spaced at regular intervals unless the Parties mutually agree in writing to a different frequency. Thereafter, the JRC shall meet at least [*] per [*], spaced at regular intervals unless the Parties mutually agree in writing to a different frequency. Following the Initial Approval Date, either Party may also call a special meeting of the JRC (by videoconference or teleconference) by at least [*] Business Days prior written notice to the other Party in the event such Party reasonably believes that a significant matter must be addressed prior to the next scheduled meeting, and such Party shall provide the JRC no later than [*] Business Days prior to the special meeting with materials reasonably adequate to enable an informed decision; provided that for time sensitive matters, a Party may call a special meeting of the JRC with less than then [*] Business Days notice if the Parties agree that an issue warrants an expedited meeting. No later than [*] Business Days prior to any meeting of the JRC, the chairperson of the JRC shall prepare and circulate an agenda for such meeting; provided, however, that either Party shall be free to propose additional topics to be included on such agenda, either prior to or in the course of such meeting. The JRC may meet in person, or at the request of either Party, by videoconference or by teleconference. In-person JRC meetings will be held at locations in the U.S. alternately selected by Medivation and by Partner. Each Party shall report to the JRC on all material issues relating to Regulatory Approvals of Products for and in the Territory at the JRC meeting

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occurring after such issues arise. Each Party will bear the expense of its respective JRC members’ participation in JRC meetings. Meetings of the JRC shall be effective only if at least one (1) representative of each Party is present or participating in such meeting. The chairperson of the JRC shall be responsible for keeping reasonably detailed written minutes of all JRC meetings that reflect all decisions made at such meetings. The JRC chairperson shall send meeting minutes to each member of the JRC for review and approval within [*] Business Days after each JRC meeting. Minutes will be deemed approved unless one or more members of the JRC objects to the accuracy of such minutes within [*] Business Days of receipt.

(d) Decision-Making. Subject to the remainder of this Section 2.4(d) and Section 2.7, the JRC shall act by consensus. The representatives from each Party will have, collectively, one (1) vote on behalf of that Party. If the JRC cannot reach consensus on an issue that comes before the JRC and over which the JRC has oversight, then such matter shall be resolved in accordance with Section 2.7(a).

2.5 Joint Manufacturing Committee.

(a) Formation; Composition. Within [*] days after the Effective Date, the Parties shall establish a committee to oversee CMC Development activities and manufacturing of clinical and commercial supplies of Products (the “JMC”). Each Party shall initially appoint three (3) representatives to the JMC, with each representative having knowledge and expertise in the manufacturing of products similar to the Products and having sufficient seniority within the applicable Party to make decisions arising with the scope of the JMC’s responsibilities. The JMC may change its size from time to time by mutual consent of its members, provided that the JMC shall consist at all times of an equal number of representatives of each of Medivation and Partner. Each Party may replace its JMC representatives at any time upon written notice to the other Party. The JMC may invite non-members (including consultants and advisors of a Party who are under an obligation of confidentiality consistent with this Agreement) to participate in the discussions and meetings of the JMC, provided that such participants are involved in activities related to Collaboration Molecules or Products and shall have no voting authority at the JMC. The JMC shall have a chairperson, who shall be selected by Partner. The role of the chairperson shall be to convene and preside at meetings of the JMC, to prepare and circulate agendas and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JMC representatives.

(b) Specific Responsibilities of the Joint Manufacturing Committee. In addition to its general responsibilities, the Joint Manufacturing Committee shall in particular:

(i) discuss, prepare and approve for submission to the JSC the Joint Manufacturing Plan and the Joint Manufacturing Budget for each Product in the Territory, including any amendments thereto;

(ii) oversee implementation of each Joint Manufacturing Plan;

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(iii) coordinate the manufacturing activities of Partner and Medivation under this Agreement with respect to Products in the Territory, including the transition of manufacturing responsibilities from Medivation to Partner pursuant to Section 6.8;

(iv) allocate primary responsibility as between the Parties for tasks relating to manufacturing of Products for Clinical Trials and for Commercialization in the Shared Territory;

(v) facilitate the flow of Information between the Parties with respect to CMC Development in the Territory;

(vi) discuss, prepare and approve for submission to the JSC annual and interim amendments to CMC Development within the Joint Development Plan and Joint Development Budget for each Product;

(vii) oversee the conduct of the CMC Development for Collaboration Molecules and Products; and

(viii) perform such other functions as appropriate to further the purposes of this Agreement, as directed by the JSC.

(c) Meetings. The JMC shall meet at least [*] per [*], spaced at regular intervals unless the Parties mutually agree in writing to a different frequency. Either Party may also call a special meeting of the JMC (by videoconference or teleconference) by at least [*] Business Days prior written notice to the other Party in the event such Party reasonably believes that a significant matter must be addressed prior to the next scheduled meeting, and such Party shall provide the JMC no later than [*] Business Days prior to the special meeting with materials reasonably adequate to enable an informed decision; provided that for time sensitive matters, a Party may call a special meeting of the JMC with less than then [*] Business Days notice if the Parties agree that an issue warrants an expedited meeting. No later than [*] Business Days prior to any meeting of the JMC, the chairperson of the JMC shall prepare and circulate an agenda for such meeting; provided, however, that either Party shall be free to propose additional topics to be included on such agenda, either prior to or in the course of such meeting. The JMC may meet in person, by videoconference, or by teleconference. In-person JMC meetings will be held at locations in the U.S. alternately selected by Medivation and by Partner. Meetings of the JMC shall be effective only if at least one (1) representative of each Party is present or participating in such meeting. Each Party shall report to the JMC on all material issues relating to the manufacturing of Products promptly after such issues arise. Each Party will bear the expense of its respective JMC members’ participation in JMC meetings. The chairperson will be responsible for preparing reasonably detailed written minutes of JMC meetings that reflect all decisions made at such meetings. The JMC chairperson shall send meeting minutes to each member of the JMC for review and approval within [*] Business Days after each JMC meeting. Minutes will be deemed approved unless one or more members of the JMC objects to the accuracy of such minutes within [*] Business Days of receipt.

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(d) Decision-Making. Subject to the remainder of this Section 2.5(d) and Section 2.7, the JMC shall act by consensus. The representatives from each Party will have, collectively, one (1) vote on behalf of that Party. If the JMC cannot reach consensus on an issue that comes before the JMC and over which the JMC has oversight, then such matter shall be resolved in accordance with Section 2.7(a).

2.6 Joint Commercialization Committee.

(a) Formation; Composition. Within [*] days after the Effective Date, the Parties shall establish a committee to oversee Commercialization of Products (other than commercial manufacture and Product distribution, which shall be overseen by the JMC, and medical information activities, which shall be governed by Section 5.11(d)) in the Territory (the “JCC”). Each Party shall initially appoint three (3) representatives to the JCC, with each representative having knowledge and expertise in the commercialization of products similar to the Products and having sufficient seniority within the applicable Party to make decisions arising with the scope of the JCC’s responsibilities. The JCC may change its size from time to time by mutual consent of its members, provided that the JCC shall consist at all times of an equal number of representatives of each of Medivation and Partner. Each Party may replace its JCC representatives at any time upon written notice to the other Party. The JCC may invite non-members (including consultants and advisors of a Party who are under an obligation of confidentiality consistent with this Agreement) to participate in the discussions and meetings of the JCC, provided that such participants are involved in activities related to Collaboration Molecules or Products and shall have no voting authority at the JCC. The JCC shall have a chairperson, who shall be selected by Partner. The role of the chairperson shall be to convene and preside at meetings of the JCC, to prepare and circulate agendas and to ensure the preparation of minutes, but the chairperson shall have no additional powers or rights beyond those held by the other JCC representatives.

(b) Specific Responsibilities of the Joint Commercialization Committee. In addition to its general responsibilities, the Joint Commercialization Committee shall in particular:

(i) in accordance with and subject to Section 5.3, discuss, prepare and approve for submission to the JSC the Revised Initial Shared Territory Commercialization Plan and Revised Initial Shared Territory Commercialization Budget, as well as the Shared Territory Commercialization Plan and Shared Territory Commercialization Budget for each Product in the Shared Territory, including any amendments thereto;

(ii) oversee implementation of each Shared Territory Commercialization Plan;

(iii) review and update financial forecasts at least quarterly to ensure actual and anticipated spend is within the approved Shared Territory Commercialization Budget or Initial Shared Territory Commercialization Budget or Revised Initial Shared Territory Commercialization Budget;

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(iv) review and discuss the Commercialization activities of Partner with respect to Products in the Shared Territory and coordinate the Commercialization activities of Medivation and Partner with respect to Co-Promotion Products, including pre-launch and post-launch activities and any other Co-Promotion activities by the Parties;

(v) review and discuss the Commercialization activities of Partner in the Licensed Territory with respect to Products; provided, however, that it is understood that with respect to [*], the role of the JCC shall be limited to [*] provided by [*], and [*], after good faith consideration of [*], shall have the final right to [*] in relation thereto subject to Section 2.7(a)(i);

(vi) allocate primary responsibility as between the Parties for tasks relating to Commercialization of Products in the Shared Territory;

(vii) review, discuss, coordinate and approve the Parties’ medical affairs activities (the responsibility for which may be delegated by the JCC to a subcommittee of the JCC that is comprised of medical representatives of the Parties), which activities shall include:

(1) field-based Medical Education Activities by either Party and grant-based medical education programs;

(2) providing funding or Product for (x) any investigator-initiated Clinical Trials for the Shared Territory and (y) investigator-initiated Clinical Trials involving [*] or [*] for the Licensed Territory (subject to the JDC’s approval), it being understood that any subcommittee tasked with oversight of any such investigator-initiated Clinical Trial shall update the JCC on the status thereof and that Partner shall provide the JCC with an informational update on any other investigator-initiated Clinical Trials in the Licensed Territory for which it has agreed to provide funding or Product;

(3) Phase 4 Clinical Trials, including the allocation of budgeted resources thereto (to the extent applicable) and the priorities thereof (subject to the JDC’s approval);

(4) the scientific presentation and publication strategy relating to the Products in the Territory; and

(5) all requests for, or proposals of, Publications pursuant to Section 12.4, with the understanding that all Publication approvals shall be consistent with the strategy established pursuant to subsection (4) above, and shall be in accordance with procedures for review as is determined by the JCC; and

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(viii) perform such other functions as appropriate to further the purposes of this Agreement, as directed by the JSC or as specified in this Agreement in Sections 5.10(a) and 8.2(a)(i).

(c) Meetings. The JCC shall meet at least [*] per [*], spaced at regular intervals unless the Parties mutually agree in writing to a different frequency. Either Party may also call a special meeting of the JCC (by videoconference or teleconference) by at least [*] Business Days prior written notice to the other Party in the event such Party reasonably believes that a significant matter must be addressed prior to the next scheduled meeting, and such Party shall provide the JCC no later than [*] Business Days prior to the special meeting with materials reasonably adequate to enable an informed decision; provided that for time sensitive matters, a Party may call a special meeting of the JCC with less than then [*] Business Days notice if the Parties agree that an issue warrants an expedited meeting. No later than [*] Business Days prior to any meeting of the JCC, the chairperson of the JCC shall prepare and circulate an agenda for such meeting; provided, however, that either Party shall be free to propose additional topics to be included on such agenda, either prior to or in the course of such meeting. The JCC may meet in person, by videoconference, or by teleconference. In-person JCC meetings will be held at locations in the U.S. alternately selected by Medivation and by Partner. Meetings of the JCC shall be effective only if at least one (1) representative of each Party is present or participating in such meeting. Each Party shall report to the JCC on all material issues relating to the Commercialization of Products promptly after such issues arise. Each Party will bear the expense of its respective JCC members’ participation in JCC meetings. The chairperson will be responsible for preparing reasonably detailed written minutes of JCC meetings that reflect all decisions made at such meetings. The JCC chairperson shall send meeting minutes to each member of the JCC for review and approval within [*] Business Days after each JCC meeting. Minutes will be deemed approved unless one or more members of the JCC objects to the accuracy of such minutes within [*] Business Days of receipt.

(d) Decision-Making. Subject to the remainder of this Section 2.6(d) and Section 2.7, the JCC shall act by consensus. The representatives from each Party will have, collectively, one (1) vote on behalf of that Party. If the JCC cannot reach consensus on an issue that comes before the JCC and over which the JCC has oversight, then such matter shall be resolved in accordance with Section 2.7(a).

2.7 Resolution of Committee Disputes.

(a) Within Operating Committees. Subject to the exceptions specified in this Section 2.7(a), all decisions within any Committee which is other than the JSC (each, an “Operating Committee”) shall be made by consensus, and if a dispute arises which cannot be resolved within such Committee, then the representatives of either Party may cause such matter to be referred to the JSC for resolution as provided in Section 2.2(e). The exceptions to this general rule are that:

(i) Partner shall have the final say, without referral of such matter to the JSC, with respect to any Operating Committee decisions that are [*], excluding any decision to conduct a Clinical Trial involving a [*] or [*] of a [*] with [*] (regardless of which Operating Committee is charged with making such decision), which will require the [*].

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(ii) Partner shall have the final say [*], without referral of such matter to the JSC, with respect to decisions regarding all [*] and [*] and other [*] activities in [*] other than the following matters (collectively, the “JCC Final Decision Exceptions”), which will require [*] of [*] and if not obtained, will be referred to the JSC: [*]

(iii) Partner shall have final say [*], without referral of such matter to the JSC, with respect to decisions regarding [*].

(b) Within The JSC. Subject to the exceptions specified below in this Section 2.7(b), all decisions within the JSC (whether originating there, or referred to it by an Operating Committee) shall be made by consensus. If a matter is referred by an Operating Committee to the JSC, it shall use good faith efforts, in compliance with Section 2.7(e), to resolve promptly such matter. If the JSC is unable to reach consensus on any issue, such issue shall be referred to the Alliance Managers. The Alliance Managers shall work with the JSC and use their commercially reasonable efforts to reach mutually acceptable resolutions on all such disputed matters. If the Alliance Managers are unable to assist the JSC in resolving such dispute within [*] Business Days after the dispute is first referred to the Alliance Managers, either Party may elect to submit such issue to the Parties’ Executive Officers in accordance with Section 2.7(c). The exceptions to this general rule are that at the JSC and without referral of such matter to the Alliance Managers or Executive Officers:

(i) Development. [*] shall have the final say with respect to all decisions regarding [*] of the [*] prior to [*] other than [*] activities; provided, however, that [*] shall not be permitted to use such final say to (1) [*] the [*] for a [*] with respect to the [*] activities included in the [*] by more than [*] of the [*] for such [*] included in the [*], in each case excluding [*] activities, (2) change the [*] of [*] (including [*]) or (3) decide to initiate (i.e., [*]) [*] in the [*] for [*] on a date which is prior to [*]. To the extent included in the Joint Development Budget, decisions with respect to (x) [*] related to [*] and (y) [*] costs (including [*] for such [*] activities) shall be made in accordance with Section 2.7(b)(iii).

(ii) Regulatory. [*] shall have the final say with respect to all decisions regarding [*] for the [*] in the [*] until [*]; except with respect to the [*] to be agreed upon with [*] for the [*], which such decision shall be referred to the Executive Officers if the JSC cannot reach agreement, pursuant to Section 2.7(c). After [*], [*] shall have the final say at the JSC if consensus cannot be reached at the JRC with respect to all [*] related to [*] in the [*]. [*] shall have the final say with respect to all [*] related to [*] for all [*] in the [*] excluding any decision to [*] a [*] involving a [*] or the [*] of a [*] with any [*].

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(iii) Manufacturing and CMC Development. [*] shall have the final say with respect to all decisions regarding Product manufacturing and CMC Development activities for the Territory, including the manufacturing of active pharmaceutical ingredients and other components of Products to be used either for Commercialization or Clinical Trials and the Joint Manufacturing Plan and Joint Manufacturing Budget, other than the Launch Product Volume if inconsistent with the Launch Product Volume Criteria; provided that if the JSC does not reach consensus on such Launch Product Volume then [*] shall manufacture Launch Product Volume in accordance with the Launch Product Volume Criteria.

(iv) Commercialization. Partner shall have the final say with respect to decisions regarding the following activities for the Shared Territory: the JCC Final Decision Exceptions set forth in [*] but not those set forth in [*], which shall be referred to the Executive Officers for final decision pursuant to Section 2.7(c); provided, however, that with respect to decisions regarding the Shared Territory Commercialization Budget under [*], if (x) the amended Shared Territory Commercialization Budget at issue is for a Calendar Year included in the Initial Shared Territory Commercialization Budget and such amended total aggregate Shared Territory Commercialization Budget for such Calendar Year exceeds by more than [*] the total aggregate budget for such Calendar Year set forth in the Initial Shared Territory Commercialization Budget attached hereto (or if such total aggregate budget has been updated and approved by the JSC, the total aggregate budget approved by the JSC), in all cases excluding [*], and (y) the JSC does not reach consensus on such amended total aggregate Budget, then such issue shall not be referred to the Executive Officers, but rather Partner shall have final say with respect to such proposed Budget and Medivation’s forty percent (40%) share of the amount in excess of such [*] amount of the total aggregate budget for such Calendar Year (“Excess Initial Shared Territory Commercialization Budget Amount”) in the Initial Shared Territory Commercialization Budget attached hereto (or if such total aggregate budget has been updated and approved by consensus of the JSC, the total aggregate budget approved by the JSC) not approved by Medivation, shall be paid by Partner but deducted from Medivation’s share of Operating Profit or otherwise any sales milestone payable under Sections 8.2 and 8.4, respectively, in accordance with the procedure set forth in Section 8.2 and 8.4, as appropriate. All other decisions or disputes regarding the Shared Territory Commercialization Budget shall be handled by the Executive Officers as set forth in Section 2.7(c)(ii). For the avoidance of doubt, decisions with respect to Manufacturing Costs shall be subject to Section 2.7(b)(iii) above.

(v) Patents Term Extensions. Partner shall have the final say with respect to all decisions regarding patent term extensions in connection with Collaboration Patents or other Partner Patents in respect of the Shared Territory and the Licensed Territory.

(c) Referral To Executive Officers. If a Party makes an election under Section 2.7(b) to refer a matter to the Executive Officers, the JSC shall submit in writing the respective positions of the Parties to their respective Executive Officers. Such Executive Officers shall use good faith efforts, in compliance with Section 2.7(e), to resolve promptly such matter, which good faith efforts shall include at least one teleconference between such Executive Officers within [*] Business Days after the JSC’s submission of such matter to them. If the Executive Officers are unable to reach consensus on any such matter, then:

(i) in regards to the [*] for the [*], [*] shall have the final say;

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(ii) with respect to the JCC Final Decision Exceptions set forth in [*] [*] shall have the final say; provided that, with respect to [*] certain disputes related to the [*] shall be finally determined by the [*], at the JSC level, as set forth in [*]. For the avoidance of doubt, decisions with respect to [*] shall be subject to [*] above; and

(iii) in regards to other matters the status quo as reflected, where relevant, in the then-current Joint Development Plan (or the then-current Initial Joint Development Plan) for the relevant Product or Joint Development Budget (or the then-current Initial Joint Development Budget) for such Product shall be maintained.

(d) Consensus Issues. Notwithstanding anything to the contrary herein, if the JDC, JCC, JSC, as applicable, and Executive Officers all fail to achieve consensus regarding any of the following issues and the then-current Joint Development Plan (or the then-current Initial Joint Development Plan) for the relevant Product or Joint Development Budget (or the then-current Initial Joint Development Budget) for such Product does not address such issue, no decision shall be made, and in the case of Section 2.7(d)(i) through (d)(iv) the status quo shall be maintained unless and until the Parties mutually agree otherwise: [*].

(e) Good Faith. In conducting themselves on Committees, and in exercising their rights under this Section 2.7, all representatives of both Parties shall consider diligently, reasonably and in good faith all input received from the other Party, and shall use reasonable efforts to reach consensus on all matters before them. In exercising any decision making authority granted to it under this Article 2, each Party shall act based on its good faith judgment of what is in the best interests of the Products and the Collaboration.

(f) Notwithstanding anything to the contrary in this Agreement, neither Party nor any of its Affiliates shall be required to take, or shall be penalized for not taking, any action that is not in compliance with such Party’s ethical business practices and policies or that such Party reasonably believes is not in compliance with Applicable Law.

2.8 Appointment of Alliance Managers. Each Party shall appoint an appropriately qualified individual to serve as Alliance Manager under this Agreement. Such persons shall endeavor to assure clear and responsive communication between the Parties and the effective exchange of Information, and may serve as a single point of contact for any matters arising under this Agreement. Alliance Managers may attend all meetings between the Parties, including Committee meetings, and shall also work together to resolve any deadlock between the Parties in accordance with the procedures set forth in Section 2.7; provided, however, that the Alliance Managers shall not be members of any Committee established pursuant to this Agreement and shall not have final decision-making authority with respect to any matter. Each Party may change its designated Alliance Manager from time to time upon written notice to the other Party.

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2.9 General Committee Authority. Each Committee shall have solely the powers expressly assigned to it in this Article 2 and elsewhere in this Agreement. No Committee shall have any power to amend, modify, or waive compliance with this Agreement. It is expressly understood and agreed that the control of decision-making authority by Medivation or Partner, as applicable, pursuant to Section 2.7, so as to resolve a disagreement or deadlock on a Committee for any matter will not authorize either Party to perform any function not delegated to a Committee, and that neither Medivation nor Partner shall have any right to unilaterally modify or amend, or waive its own compliance with, the terms of this Agreement.

2.10 Discontinuation of Participation on a Committee. Each Committee shall continue to exist until the first to occur of (a) the Parties mutually agreeing to disband the Committee, (b) Medivation providing to Partner written notice of its intention to disband and no longer participate in such Committee, which Medivation retains the right to do at any time during the Term, in its sole discretion, and (c) an election by Partner pursuant to Section 13.6 to disband the Committees. In the event Medivation has provided written notice as referred to in this Section 2.10 such affected Committee shall have no further force and effect or obligations under this Agreement but all decisions formerly made within or by such Committee shall become a decision as between the Parties. In the event Partner has elected to disband the Committees pursuant to Section 13.6, such affected Committee shall have no further force and effect or obligations under this Agreement and Partner shall have the right to solely decide, without consultation with Medivation, any matters previously before any such Committee in which case references in this Agreement to approvals or actions of a Committee shall thereafter be deemed to be satisfied by approvals or actions of Partner and Partner shall also have the sole right to decide, without consultation with Medivation, matters described in Sections 2.7(c) and 2.7(d).

ARTICLE 3

DEVELOPMENT

3.1 Overview. The Parties agree to collaborate in the Development of Collaboration Molecules and Products as provided in this Article 3 under the direction of the JDC, and pursuant to the Joint Development Plan(s).

3.2 Development Program.

(a) General. The Parties intend and agree to undertake a joint development program to further Develop the Initial Dimebon Product and [*] (such program, the “Development Program”) in accordance with the terms of this Article 3. All Development of any given Product in the Field and for the Territory shall be conducted pursuant to a comprehensive, worldwide development plan approved by the JSC (including the Initial Joint Development Plan, the “Joint Development Plan”) that describes (i) the proposed overall

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program of Development for the applicable Product in the Territory, including Non-Clinical Studies, toxicology, CMC Development, Clinical Trials, regulatory plans and other elements of obtaining Regulatory Approval(s), and associated timelines and priorities indicating, where applicable, those activities that relate solely to the Licensed Territory; (ii) for the Key Markets, timelines for key Regulatory Authority meetings, filing of applications for Regulatory Approval, and the receipt of Regulatory Approvals, (iii) the anticipated tasks and responsibilities and resource allocation of each Party, and (iv) a Joint Development Budget for all such activities. Both Parties shall have the right to propose to the JDC any additional Non-Clinical Studies or Clinical Trials not then part of a Joint Development Plan with respect to a Product or the expansion of Development under a Joint Development Plan to include any new indication(s) for the Product covered thereunder. If the JSC determines to discontinue Developing a Product upon recommendation by the JDC, the Joint Development Plan for such Product shall terminate upon such decision. In the event of any inconsistency between the Joint Development Plan and this Agreement, the terms of this Agreement shall prevail.

(b) Initial Joint Development Plan. The Joint Development Plan for the Initial Dimebon Product for the Initial Indications in the [*] and the Development of [*] for the [*] is attached hereto as Exhibit E (the “Initial Joint Development Plan”). The Initial Joint Development Plan includes the Non-Clinical Studies and Clinical Trials needed to obtain Regulatory Approval for the Initial Dimebon Product for the Initial Indications in the [*] (the “Initial Approval Studies”). It is understood that subsequently, the JDC will determine and include in the Joint Development Plan the [*] the Parties will use to decide whether to pursue a [*]. The JDC shall designate a joint development working group with members from each Party (as designated by such Party) to meet as soon as reasonably practicable after the Effective Date to discuss, recommend changes and finalize the outstanding issues related to the Initial Joint Development Plan attached hereto as Exhibit F. If such working group cannot agree on how to proceed with any of such outstanding issues then such issue shall be referred to the JDC. The Initial Joint Development Plan shall be effective from the Effective Date until amended and updated by the JDC and approved by the JSC.

(c) Amendments to the Joint Development Plan. On an annual basis (no later than [*] of the preceding Calendar Year), or more often as the Parties deem appropriate, the JDC shall prepare amendments to the then-current Joint Development Plan(s), and the corresponding Joint Development Plan Budget(s) for approval of the JSC. Each such amended Joint Development Plan shall specify, with a level of detail according to Partner’s standard practices, the items described in Section 3.2(a). Such amended Joint Development Plan shall cover the next Calendar Year (and additional periods as reasonably determined by Partner) and shall contain a corresponding Joint Development Plan Budget, which budget shall appropriately itemize the costs separately for each Product. Such updated and amended Joint Development Plan shall reflect any changes, re-prioritization of studies within, reallocation of resources with respect to, or additions to the then-current Joint Development Plan. In addition, the JDC may prepare amendments for approval of the JSC to the Joint Development Plan and corresponding Joint Development Budget from time to time during the Calendar Year in order to reflect changes in such plan and budget for such Calendar Year, in each case, in accordance with the foregoing.

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Once approved by the JSC, the amended annual Joint Development Plan and Joint Development Budget shall become effective for the applicable period on the date approved by the JSC (or such other date as the JSC shall specify). Any JSC-approved amended Joint Development Plan and Joint Development Budget shall supersede the previous Joint Development Plan and Joint Development Budget for the applicable period.

(d) Development Responsibilities. Subject to Sections 3.2(e) and 13.2, each Party shall be obligated to conduct and fund the Development of a Collaboration Molecule or Product in accordance with the then-approved Joint Development Plan (including all associated timelines) and corresponding Joint Development Budget. Unless the Parties agree in writing upon an alternate allocation of responsibility, the Parties shall have the following rights and obligations with respect to the operational responsibilities under each Joint Development Plan:

(i) Lead Development Party. The lead development Party shall, on a study-by-study basis, have primary operational responsibility for leading the conduct of and executing such study under the Joint Development Plan as then in effect, subject to the right of the other Party to participate in such activities as are allocated to it under such plan, and to provide input, which the lead development Party will consider in good faith. The other Party shall be entitled to have its representatives (including those in Clinical, Biostatistics, Study/Project Management and Pharmaceutical Sciences) participate in any decision regarding the planning of such studies and strategy for the trial design of such studies, as desired by such other Party. In the event the Parties disagree with aspects of the planning and strategy on Non-Clinical Studies or Clinical Trials, then the Parties shall refer such disagreement to the JDC. In addition, such other Party shall have the right to attend and participate in all key study meetings, including advisory boards, consultants’ meetings, investigator meetings, data safety monitoring board meetings, and meetings where data analysis and interpretation or changes to the Initial Joint Development Plan will be discussed and discussions on any significant issue that arises regarding the conduct or execution of the Initial Development Plan. [*] shall as soon as reasonably practicable inform [*] of any changes in the conduct or execution of Non-Clinical Studies or Clinical Trials included in the Initial Joint Development Plan, including changes to the Clinical Trial protocol, the statistical analysis plan and study sites and any developments that could affect the ability of a site to properly conduct a Clinical Trial.

(ii) Shared Territory. The lead development Party for each of the Initial Approval Studies of the Initial Dimebon Product through receipt of the first Regulatory Approval in the Shared Territory of the Initial Dimebon Product for the first indication, other than [*], included in the Initial Indications (the “Initial Approval Date”) shall be as set out in Exhibit E, after which point the lead development party shall be determined, on a study-by-study basis, by the JDC, and as reasonably allocated between the Parties.

(iii) Licensed Territory. [*] shall be the lead development Party for all Development of Collaboration Molecules and Products, including the Initial Dimebon Product, that is solely applicable to the Licensed Territory.

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(iv) Alliance Managers. In implementing a Joint Development Plan, each Party shall keep its Alliance Manager sufficiently informed so as to enable such individuals to liaise with the JDC to resolve any questions regarding such Party’s implementation of the Joint Development Plan and to communicate to the Joint Development Committee timely suggestions for improving the Joint Development Plan.

(e) Development Costs.

(i) Subject to Section 6.4(a), Medivation shall be responsible for forty percent (40%) and Partner shall be responsible for sixty percent (60%) of all Joint Development Costs. Partner shall be responsible for one hundred percent (100%) of all Development Costs for the Licensed Territory to the extent that such costs are not included in Joint Development Costs. Notwithstanding the foregoing, for any Calendar Year, neither Partner nor Medivation would be permitted to recover Joint Development Costs in excess of [*] of the amount allocated to such Party’s Development activities for such year under the Joint Development Budget in each case excluding the [*] and [*], without unanimous approval of the JSC, which approval may be granted either in advance of such costs being incurred or retroactively.

(ii) The Parties agree that Partner may without further expense use any and all Information it receives or learns under the Collaboration, whether existing as of the Effective Date or developed for Collaboration Molecules and Products in the Shared Territory during the Term, to Develop and Commercialize Products in the Licensed Territory.

3.3 Development Diligence and Standards of Conduct. The Parties agrees to use Diligent Efforts to Develop and obtain Regulatory Approval for at least the [*] and [*] throughout [*] pursuant to the Initial Joint Development Plan. Each Party shall use Diligent Efforts to carry out the tasks assigned to it under the Joint Development Plan. Each Party shall conduct its activities under the Joint Development Plan in a good scientific manner and in compliance with all Applicable Laws.

3.4 Development Records and Reports. Each Party shall maintain complete and accurate records (in the form of technical notebooks and/or electronic files where appropriate) of all work conducted by it under the Joint Development Plan and all Information resulting from such work. Such records, including any electronic files where such Information may also be contained, shall fully and properly reflect all work done and results achieved in the performance of the Joint Development Plan in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times and to obtain access to originals to the extent needed for patent or regulatory purposes or for other legal proceedings. Each Party shall provide the JDC with such reports detailing its Development activities under the Joint Development Plan and the results of such activities as the JDC requests.

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3.5 Subcontracts. Subject to Section 7.4, each Party may perform any of its Development obligations under this Agreement through one or more subcontractors or consultants.

ARTICLE 4

REGULATORY MATTERS

4.1

Regulatory Filings and Approvals.

(a) In General. The Parties intend that each Joint Development Plan shall set forth the regulatory strategy for seeking Regulatory Approvals for a Product in the Field in the Territory. All decisions regarding Regulatory Issues shall be made in accordance with the decision-making rules that are set forth in Article 2.

(b) Regulatory Responsibilities.

(i) Lead Regulatory Party. Except as provided in Section 4.1(b)(ii), the lead regulatory Party, on a jurisdiction-by-jurisdiction basis, shall be responsible for preparing and filing all Regulatory Materials, shall be the holder of all Regulatory Approvals in such jurisdiction and will have primary operational responsibility for interactions with Regulatory Authorities, including taking the lead role at all meetings with Regulatory Authorities, subject to the right of the other Party to participate in such activities and provide input, which the lead regulatory Party will consider in good faith; provided, however, that any INDs or their foreign equivalents will be prepared, filed and held by the Party conducting the relevant Clinical Trial that is the subject thereof. Subject to Section 4.1(c)(ii), this right of participation covers all regulatory activities, including development of regulatory strategy and review of regulatory submissions, attendance at all meetings with Regulatory Authorities that may potentially impact the Development of the Collaboration Molecule or Product or registration package for a particular Product, and review of outcomes of such meetings.

(ii) Shared Territory. [*] shall be the lead regulatory Party for the [*] in the Shared Territory up to and including the [*]. [*] shall be the lead for preparing the clinical and nonclinical content of the initial application, whereas [*] shall be the lead for preparing the manufacturing section. Review and approval of the marketing application will be by both Parties in accordance with Section 4.1(c)(i) and Article 2. [*] shall be responsible for electronic assembly and publishing of all sections of the NDA and MAAs in order to ensure that all marketing authorization applications for the Territory for the Initial Dimebon Product are consistent and are prepared from a common repository of applicable Information for submission by the lead regulatory Party in each jurisdiction. After the [*], [*] shall be the lead regulatory Party for the [*] for [*] and [*] shall [*] of such [*] (and [*]) to [*] pursuant to the Initial Joint Development Plan. In addition, [*] shall be the lead regulatory Party for [*] in the Shared Territory.

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(iii) Licensed Territory. Partner shall be the lead regulatory Party in the Licensed Territory for all Products, including the Initial Dimebon Product.

(c) Reporting and Review.

(i) The JRC shall develop and implement procedures for drafting and reviewing Regulatory Materials for Products in the Key Markets, which shall provide sufficient time for each Party to provide substantive comments prior to the filing of such Regulatory Materials.

(ii) Each Party shall promptly notify the other Party of all Regulatory Materials that it submits for Products and shall promptly provide the non-responsible Party with a copy (which may be wholly or partly in electronic form) of such Regulatory Materials throughout the Territory. The Party primarily responsible for such Regulatory Materials will provide the non-responsible Party with reasonable advance notice of any scheduled meeting with any Regulatory Authority and/or any Regulatory Materials with respect to Products throughout the Territory, and the non-responsible Party shall have the right to participate in any such meeting, to the extent permitted by Applicable Laws and with a Regulatory Authority for a Key Market. Representatives of the Party primarily responsible for such Regulatory Materials will be the primary spokespeople at any such meeting and shall be given preference in attending such meeting in the event that the number of attendees is limited by either such Regulatory Authority or upon the reasonable good faith judgment of the Parties; provided that in any event each Party may have at least one representative present at such meeting in the Key Markets. The Parties acknowledge such limits on the number of attendees may dictate that an unequal number of participants from each Party will be in attendance at such meeting. The Party primarily responsible for such Regulatory Materials also shall promptly furnish the non-responsible Party with copies of all material correspondence to or from, and minutes of material meetings with, any Regulatory Authority relating to Development of such Product.

4.2 Regulatory Costs.

(a) All Regulatory Costs incurred by the Parties pursuant to either the approved Joint Development Plan or Shared Territory Commercialization Plan for Products for the Shared Territory shall be shared by the Parties as Joint Commercialization Costs. All Regulatory Costs for the Licensed Territory shall be borne solely by Partner.

(b) The Parties agree that Partner may without further expense use any and all Information it receives or learns under the Collaboration, whether existing as of the Effective Date or prepared for Collaboration Molecules and Products with respect to regulatory activities of Collaboration Molecules and Products in the Shared Territory during the Term, to Develop and Commercialize Products in the Licensed Territory.

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4.3 Product Withdrawals and Recalls.

(a) Shared Territory. If any Regulatory Authority (a) threatens, initiates or advises any action to remove any Product from the market in the Shared Territory or (b) requires or advises Medivation, Partner, their Affiliates, or their Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in the Shared Territory, then Medivation or Partner, as applicable, shall notify the other Party of such event within three (3) Business Days (or sooner if required by Applicable Laws) after such Party becomes aware of the action, threat, advice or requirement (as applicable). The JSC will discuss and attempt to agree upon whether to recall or withdraw a Product in the Territory; provided, however, that if the Parties fail to agree within an appropriate time period, [*] shall decide whether to recall or withdraw such Product in the Shared Territory. Any recall expenses with respect to Products within the Shared Territory shall be treated as Joint Commercialization Costs except to the extent that the recall or withdrawal is attributable to the negligence or willful misconduct of a Party in which event (i) such Party shall bear such costs for which it is responsible and (ii) such costs shall not be included in Joint Commercialization Costs.

(b) Licensed Territory. If any Regulatory Authority (a) threatens, initiates or advises any action to remove any Product from the market in the Licensed Territory or (b) requires or advises Medivation, Partner, their Affiliates, or their Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in the Licensed Territory, then Medivation or Partner, as applicable, shall notify the other Party of such event within three (3) Business Days (or sooner if required by Applicable Laws) after such Party becomes aware of the action, threat, advice or requirement (as applicable). The JSC will discuss and attempt to agree upon whether to recall or withdraw a Product in the Territory; provided, however, that if the Parties fail to agree within an appropriate time period, Partner shall decide whether to recall or withdraw such Product in the Licensed Territory. Partner shall be responsible, at its sole expense, for conducting any recalls or taking such other necessary remedial action in the Licensed Territory except to the extent that the recall or withdrawal is attributable to the negligence or willful misconduct of Medivation in which event Medivation shall bear the expense for which it is responsible.

4.4 Safety Reporting. The Parties shall meet and agree upon a written plan for exchanging adverse event and other safety information relating to Products prior to Partner’s initiation of any clinical or marketing activity implying pharmacoviligance obligations for the Product in the Territory. Such written plan shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party to comply with Applicable Laws, including any local regulatory requirements.

4.5 Standards of Conduct. Each Party shall make regulatory filings, seek Regulatory Approvals and conduct all other regulatory activities under this Article 4 in compliance with all Applicable Laws, including any applicable anti-bribery laws and regulations.

4.6 Subcontracts. Subject to Section 7.4, each Party may perform any of its regulatory activities under this Agreement through one or more subcontractors or consultants.

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ARTICLE 5

COMMERCIALIZATION

5.1 Overview. The Parties agree to collaborate with respect to the Commercialization of Products in the Field in the Shared Territory as provided in this Article 5 under the direction of the JCC and the JSC, and pursuant to the Shared Territory Commercialization Plan applicable to each Product. Partner shall have the sole right and responsibility for Commercializing Products in the Field in the Licensed Territory in accordance with this Agreement and as provided in this Article 5.

5.2 Shared Territory Commercialization Plan. As further described in this Section 5.2, the strategy for the commercial launch of, and subsequent Commercialization of, each Product in the Shared Territory shall be described in a comprehensive plan (each such plan, including the Initial Shared Territory Commercialization Plan, and any revisions thereto, a “Shared Territory Commercialization Plan”) that describes the (a) pre-launch, launch and subsequent Commercialization activities for such Product in the Shared Territory (including without limitation messaging, branding, pricing, advertising, education, planning, marketing, sales force training and allocation), (b) key tactics for implementing those activities, (c) the relative responsibilities of the Parties, (d) Field Force Detailing Plan, and (e) the commercialization budget for such Product in the Shared Territory (each such budget, including the Initial Shared Territory Commercialization Budget, and any revisions thereto, a “Shared Territory Commercialization Budget”). Notwithstanding the preceding sentence, a high-level initial Shared Territory Commercialization Plan and Shared Territory Commercialization Budget covering the pre-launch Commercialization activities through First Commercial Sale is attached hereto as Exhibit G (respectively, the “Initial Shared Territory Commercialization Plan” and “Initial Shared Territory Commercialization Budget”). The Parties anticipate that, following the Effective Date, the Initial Shared Territory Commercialization Plan and the Initial Shared Territory Commercialization Budget will also include, as greater clarity is obtained with respect to the Product, the plans and budget for the period commencing with [*] until the period ending [*] after [*] of [*] (the “Revised Initial Shared Territory Commercialization Plan” and the “Revised Initial Shared Territory Commercialization Budget”), which in turn will be incorporated into the overall detailed Shared Territory Commercialization Plan and the Shared Territory Commercialization Budget. Each Shared Territory Commercialization Plan and Shared Territory Commercialization Budget and subsequent revisions thereto will contain the information described above in this Section 5.2 and other information the JCC believes necessary for the successful commercial launch and subsequent Commercialization of such Product. Each Shared Territory Commercialization Plan and Shared Territory Commercialization Budget shall generally conform to the level of detail utilized by Partner in preparation of its own product commercialization plans. The Parties acknowledge that certain items of the Shared Territory Commercialization Plan and Shared Territory Commercialization Budget (including the Revised Initial Shared Territory Commercialization Plan or the Revised Initial Shared Territory

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Commercialization Budget) may need to be determined after certain events (i.e., with respect to pricing and Sales Representative support decisions receipt of the final Product label). In such event the Parties shall amend such plan pursuant to Section 5.3 to include such items when the relevant information is received. In the event of any inconsistency between a Shared Territory Commercialization Plan or a Shared Territory Commercialization Budget and this Agreement, the terms of this Agreement shall prevail.

5.3 Amendments to the Joint Commercialization Plans and Budgets. The JCC shall develop a final Revised Initial Shared Territory Commercialization Plan and Revised Initial Shared Territory Commercialization Budget for such Product at least [*] prior to the then-current date of expected first Regulatory Approval for such Product in the Shared Territory as determined by the JCC (such date, the “Anticipated Approval Date” for such Product) for approval by the JSC. In addition, the JCC shall prepare on an annual basis (no later than [*] of the preceding Calendar Year), and provide to the JSC for approval an updated Shared Territory Commercialization Plan and the corresponding Shared Territory Commercialization Budget. Such amended Shared Territory Commercialization Plan and the corresponding Shared Territory Commercialization Budget shall cover the next Calendar Year and such budget shall appropriately itemize the costs separately for each Product. The JCC may prepare amendments to the Shared Territory Commercialization Plan and corresponding Shared Territory Commercialization Budget from time to time during the Calendar Year in order to reflect changes in such plan and budget for such Calendar Year. JSC approval of each Shared Territory Commercialization Plan and Shared Territory Commercialization Budget, or any amendment thereto shall not be required except where the total aggregate budget for a Calendar Year included in such updated Shared Territory Commercialization Budget exceeds the total aggregate budget for such Calendar Year in the then-current Shared Territory Commercialization Budget by more than [*] in each case excluding [*]; and provided, however that [*] of [*] will be required for each Revised Initial Shared Territory Commercialization Budget, subject to Section 2.7(b)(iv). Any amended or updated Shared Territory Commercialization Plan and Shared Territory Commercialization Budget shall become effective on the date approved by the JCC (or such other date as the JCC shall specify, or where applicable, when the Executive Officers so approve) unless such Shared Territory Commercialization Plan and Shared Territory Commercialization Budget are approved by the JSC, in which case such Shared Territory Commercialization Plan and Shared Territory Commercialization Budget shall become effective for the applicable period on the date approved by the JSC (or such other date as the JSC shall specify, or where applicable, when the Executive Officers so approve).

5.4 Licensed Territory Commercialization Plans. Partner shall provide informational updates to the JCC of its Commercialization plans with respect to Products in the Licensed Territory on an [*] basis; and shall respond in a timely fashion to any reasonable requests of Medivation with respect to such plans and Commercialization activities in the Licensed Territory. Partner will consider in good faith Medivation’s input on such plans, provided that Partner shall have final decision making authority at the JCC with respect to Commercialization of Products in the Licensed Territory.

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5.5 Commercialization Costs. Partner shall be solely responsible for all costs and expenses incurred by or on behalf of Partner in the Commercialization of Products in the Licensed Territory. Medivation shall be responsible for forty percent (40%) and Partner shall be responsible for sixty percent (60%) of Joint Commercialization Costs. Notwithstanding the foregoing, for any Calendar Year, neither Partner nor Medivation would be permitted to recover Joint Commercialization Costs, excluding [*], in excess of [*] of the amount allocated to such Party’s Commercialization activities for such year under the Shared Territory Commercialization Budget without the unanimous approval of the JSC, which approval may be granted either in advance of such costs being incurred or retroactively.

5.6 Sales and Distribution. Partner shall be solely responsible for handling all returns, recalls, order processing, invoicing and collection, distribution, and receivables for Products in the Territory. Medivation shall not accept orders for Products or sell Products for its own account or for Partner’s account, and if Medivation receives any order for Products in the Territory, it shall refer such orders to Partner for acceptance or rejection.

5.7 Commercialization Reports. Each Party shall keep the JCC fully informed regarding the progress and results of Commercialization activities for Products in the Shared Territory, including an annual review of results versus plans (as set forth in the Shared Territory Commercialization Plan(s)).

5.8 Commercialization Standards of Conduct.

(a) Compliance. Each Party shall in all respects comply with all Applicable Laws and applicable guidelines concerning the advertising, sales and marketing of prescription drug products described in Section 5.11(j)(i) in Commercializing Products in the Territory under this Agreement, including without limitation the Foreign Corrupt Practices Act of 1977, as amended (“FCPA”) and any applicable local anti-bribery laws. Partner represents and warrants to Medivation that, (a) as of the Signing Date, Partner and its Affiliates have a system of internal accounting controls in place that are sufficient to provide reasonable assurances of compliance as required by the FCPA, and (b) Partner shall obligate any Sublicensees it or its Affiliates may engage with respect to Products to do the same; to bring any non-compliance therewith (should it ever occur) by any of the foregoing entities to Partner’s attention; and to promptly remedy any such non-compliance. Partner and its Affiliates shall maintain such procedures throughout the Term and shall promptly notify Medivation in writing with respect to any material non-compliance (other than non-compliance of the FCPA which shall be without regard to materiality) regarding Commercialization of Products. Medivation represents and warrants to Partner that, as of the Signing Date, (i) all Information provided by Medivation during Partner’s pre-contractual due diligence, including all information provided in the FCPA Due Diligence Questionnaire, is complete, truthful and accurate, and (ii) in conducting the Development of Dimebon and the Initial Dimebon Product, Medivation and its Affiliates have complied with the FCPA, and with all other applicable anti-corruption laws, and neither it, nor any director, officer, agent, employee, or Affiliate of Medivation, is aware of any action or any allegation of any action, or has taken any action, directly or indirectly, in furtherance of an offer, promise to pay,

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or payment of any money, property, gift, or anything else of value, to (x) any Government Official (as such term is defined in [*] to be provided by Partner on or after the Effective Date) for the purpose of influencing any act or decision of that Government Official in his or her official capacity; inducing the Government Official to use his or her influence with any government or office thereof to affect or influence any act or decision of such government or office; or to secure any improper advantage; (y) any foreign political party, or official thereof, or any candidate for foreign political office, for the purpose of influencing any act or decision of such party, official, or candidate; inducing the party, official, or candidate to use its or his or her influence with any foreign government or office thereof to affect or influence any act or decision of such government or office; or to secure any improper advantage; or (z) any person, while knowing that all or a portion of such money, property, gift, or thing of value would be offered, given or promised to any Foreign Official, foreign political party or party official, or candidate for foreign political office, for the purpose of influencing any act or decision of that official, party or candidate to use his or her influence with any government or office thereof to affect or influence any act or decision of such government or office, or to secure any improper advantage. Each Party agrees to provide to the other Party within [*] days after the end of [*] an executed copy of the compliance certification attached hereto as Exhibit I, provided that, at such time, [*] has been finalized and made available to the Parties. Medivation shall promptly notify Partner in writing with respect to any material non-compliance (other than non-compliance of the FCPA which shall be without regard to materiality) regarding Commercialization of Products.

(b) Diligence Obligations. Partner and Medivation each shall use Diligent Efforts to Commercialize at least [*] and [*] [*] in the Shared Territory, and Partner shall use Diligent Efforts to Commercialize at least [*] and [*] throughout the Licensed Territory, in each case following obtaining Regulatory Approval therefore. Each Party shall use Diligent Efforts to carry out the tasks assigned to it under the Shared Territory Commercialization Plan in compliance with all Applicable Laws.

5.9 Subcontracts. Subject to Section 7.4, each Party may perform any of its obligations under the Shared Territory Commercialization Plan (but not the fielding of a sales force) through one or more subcontractors or consultants.

5.10 Co-Promotion of Products by Medivation.

(a) Co-Promotion. Subject to Section 5.11(e)(i), in the Shared Territory, Medivation shall participate with Partner in Detailing (but not selling), promoting and marketing each Product to Specialists on the terms and conditions set forth in this Section 5.10 and Section 5.11 and shall have the right to provide between [*] and [*] of the Specialty Detail Effort for each Product in the Shared Territory, with the exact percentage to be determined within such range by Medivation (the “Medivation Promotional Share”). Medivation shall initially specify the level of Medivation Promotional Share on or before [*] of the [*] for the applicable Product. Unless otherwise requested by Medivation and approved by the JCC, such level of Medivation Promotional Share shall remain in effect for [*] of the [*] in which the First Commercial Sale of the Product in the Shared Territory occurs, and the [*] thereafter. Commencing with the [*]

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following the First Commercial Sale of the Product in the Shared Territory, and [*] thereafter, Medivation may change the level of Medivation Promotional Share with respect to such Product, by not more than [*] of the Specialty Detail Effort from the prior [*] provided that it remains within the range of [*] to [*] of the Specialty Detail Effort for the then-current [*] for such Product in the Shared Territory and it provides the JCC with [*] days prior written notice of such change. Medivation may change the level of Medivation Promotional Share at any other time, and in any other amount up to a maximum of [*] of the then-current Specialty Detail Effort, with the prior approval of the JCC.

(b) Co-Promotion Product. A Product which is being, or will be, Co-Promoted under the same trademark by both Parties under this Agreement is referred to herein as a “Co-Promotion Product.”

(c) Co-Promotion Period. The “Co-Promotion Period” shall commence on the First Commercial Sale of any Co-Promotion Product in the Shared Territory and shall continue until the earlier of (a) termination of the Parties’ Commercialization of the applicable Co-Promotion Product in the Shared Territory, as determined by the mutual agreement of the Parties, and (b) the effective date of termination of Medivation’s right to Co-Promote the Co-Promotion Products pursuant to Section 5.11(i) below.

(d) Detailing.

(i) The Parties shall establish an annual detailing and targeting plan (“Field Force Detailing Plan”) for inclusion in the Shared Territory Commercialization Plan. Such plan shall include the Specialty Detail Effort and number of Details to be conducted to primary care physicians and Non-Prescribers. With respect to the Specialty Detail Effort, such plan shall include the targeted healthcare provider segments and number of Details to be conducted by each Party, consistent with the Medivation Detail Requirement. The JCC shall, in a manner consistent with the Medivation Promotional Share, equitably allocate responsibility for the Specialty Detail Effort between the Parties’ respective Sales Representatives among particular groups of Specialists, including equitable allocation (access and potential) of target and high decile prescribers and practices.

(ii) In consultation with Partner, Medivation shall establish a computer-based system, consistent with Partner’s internal practice of recording and tracking Details of Product in the Shared Territory, that shall accurately record and track all Details by the Medivation Sales Representatives, which system design shall be subject to audit by Partner to ensure such system is consistent with Partner’s practice. Each Party shall deliver to the other Party a preliminary report containing its good faith estimate of the number of Details conducted by the Medivation Sales Representatives during each Calendar Quarter or Partner’s Sales Representatives during each Partner Quarter, as the case may be, no later than [*] days after the end of each Calendar Quarter. No later than [*] days after the end of such Calendar Quarter, each Party shall deliver to the other Party a report indicating the actual number of Details conducted by such Party for such Calendar Quarter (in the case of Medivation) or Partner Quarter

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(in the case of Partner). Medivation shall include in its calculation of Joint Commercialization Costs pursuant to Section 8.2 its Field Force Detailing Cost for the applicable Calendar Quarter; provided that if the aggregate number of Details for the Calendar Quarter and each of the previous Calendar Quarters for the Calendar Year is greater than [*] of the Medivation Detail Requirement, then only the incremental Field Force Detailing Cost for such Calendar Quarter up to and including [*] of the Medivation Detail Requirement shall be included in Joint Commercialization Costs for such Calendar Quarter and subject to Section 5.10(d)(iii), Medivation shall not include any additional Field Force Detailing Cost in Joint Commercialization Cost for the remainder of the Calendar Year. Partner shall include in its calculation of Joint Commercialization Costs pursuant to Section 8.2 its Field Force Detailing Cost for the applicable Partner Quarter; provided that if the aggregate number of Details to each of Specialists, primary care physicians or Non-Prescribers, for the Partner Quarter and each of the previous Partner Quarters for the Partner Year with respect to such Specialists, primary care physicians or Non-Prescribers is greater than [*] of the number of Details allocated to Partner for that group in the Field Force Detailing Plan, then only the incremental Field Force Detailing Cost up to and including [*] of the number of Details allocated to Partner for such group shall be included in Joint Commercialization Costs and subject to Section 5.10(d)(iii), Partner shall not include any additional Field Force Detailing Cost in Joint Commercialization Cost for the remainder of the Partner Year for such group.

(iii) If a Party believes that it will provide less than the aggregate number of Details required to be provided by it to Specialists for a Calendar Year (with respect to Medivation) or Partner Year (with respect to Partner) pursuant to the Field Force Detailing Plan, it shall notify the other Party. If in any Calendar Year either Party notifies the other Party that it will provide less than the aggregate number of Details required to be provided by it to Specialists for such Calendar Year or Partner Year, as applicable, pursuant to the Field Force Detailing Plan, then the other Party shall be entitled (but shall not be obligated) to provide such additional Details as may be necessary to make up some or all of such shortfall and shall include the Field Force Detailing Costs associated with replacing the unprovided Details (to the extent actually replaced by such other Party) in its calculation of Joint Commercialization Costs pursuant to Section 8.2 notwithstanding the limitation set forth in Section 5.10(d)(ii).

(iv) Neither Party’s Sales Representatives shall be permitted to Detail more than [*] (inclusive of [*] being [*] by [*] on [*].

(e) Reimbursement and Managed Care Activities. [*] shall be the lead managed care/reimbursement Party, responsible for the operational aspects of managing and carrying out efforts related to obtaining reimbursement for Products in the Shared Territory and the negotiation of managed care arrangements; it being understood that all decision-making related to reimbursement and managed care matters shall be done by the JCC with oversight by the JSC. [*] shall be entitled to provide input on such matters, which input [*] will consider in good faith. [*] will also make a good faith effort to involve [*] in clinical and formulary presentations and in meetings with regional accounts.

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(f) Other Terms. In addition to the terms set forth in this Section 5.10, Co-Promotion of any Co-Promotion Product shall be conducted pursuant the terms set forth in Section 5.11 during the applicable Co-Promotion Period.

5.11 Co-Promotion Terms.

(a) Governance. Subject to Article 2, the Parties’ Co-Promotion activities for any Product in the Shared Territory shall be overseen by the JCC and governed by the Shared Territory Commercialization Plan. The JCC shall use reasonable and good faith efforts to allocate the Co-Promotion activities in a manner to give effect to the sales and marketing strategy described in the Shared Territory Commercialization Plan and in the best interests of the applicable Co-Promotion Product.

(b) Advertising and Promotional Materials. The Parties shall jointly prepare and produce all Promotional Materials for Co-Promotion Products in the Shared Territory, provided, however, that the JCC shall approve all such Promotional Materials to ensure consistency across the entire field of effort of both Parties. Promotional Materials shall not be used unless approved by the JCC. Subject to Applicable Law, all such Promotional Materials shall include, with equal prominence, the names and logos of both Parties. The JCC shall determine the manner in which the Parties will be presented and described to the medical community in any Promotional Materials or other materials related to a particular Co-Promotion Product and the placement of the names and logos of the Parties, in each case as permitted by Applicable Law and the labeling for such Co-Promotion Product approved by the applicable Regulatory Authority. Partner shall own all right, title and interest in and to any and all such Promotional Materials, including all applicable copyrights, trademarks (other than Medivation’s name and logo), program names and domain names.

(c) Samples. The Shared Territory Commercialization Plan shall include mutually agreeable procedures for supplying reasonable requirements of Samples of each Co-Promotion Product to the Medivation Sales Representatives.

(d) Medical Information. Prior to the First Commercial Sale of the Initial Dimebon Product, [*] shall be responsible for responding to medical information requests from healthcare professionals and consumers in accordance with its standard practice for such activity. Medivation and Partner shall discuss and agree upon procedures for responding in a consistent manner to medical information requests on Products from healthcare professionals and consumers received after the First Commercial Sale of the Initial Dimebon Product. In the event that the Parties cannot reach consensus on any decisions regarding such procedures, [*].

(e) Medivation Sales Force.

(i) Medivation’s right to Co-Promote Co-Promotion Products shall be contingent upon Medivation’s employment of (a) Sales Representatives who at the time of employment by Medivation have not less than [*] years of [*] sales experience in the U.S.

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(collectively “Medivation Sales Representatives”), (b) at least one (1) full-time sales manager for every [*] Medivation Sales Representatives to manage and monitor the Medivation Sales Representatives, with each such sales manager having at the time of employment by Medivation not less than [*] years of experience in supervising pharmaceutical Sales Representatives and (c) at least [*] sales force trainers who at the time of employment by Medivation have not less than [*] years of experience in [*] in the pharmaceutical industry, including part-time experience (the “Medivation Sales Force Trainers”, and, together with the Medivation Sales Representatives and the Medivation sales manager(s), collectively, the “Medivation Sales Force”).

(ii) Medivation shall have sole responsibility for all costs and expenses in connection with the Medivation Sales Force including, without limitation, salaries, travel expenses and other expenses, providing benefits, deducting federal, state and local payroll taxes, FICA contributions, FUI, DUI and any similar taxes and paying workers’ compensation premiums, unemployment insurance contributions and any other payments required by Applicable Laws to be made on behalf of employees. Nothing in this Agreement shall be construed to conclude that any of Medivation Sales Force or any other agents or employees of Medivation are agents or employees of Partner or subject to Partner’s direction and control. Medivation shall have sole authority over the terms and conditions of employment of the Medivation Sales Force, including their selection, management, compensation (including incentive plans) and discharge.

(f) Partner Sales Force. Partner shall have sole responsibility for all costs and expenses in connection with Partner’s sales force, including, without limitation, salaries, travel expenses and other expenses, providing benefits, deducting federal, state and local payroll taxes, FICA contributions, FUI, DUI and any similar taxes and paying workers’ compensation premiums, unemployment insurance contributions and any other payments required by Applicable Laws to be made on behalf of employees. Nothing in this Agreement shall be construed to conclude that any of Partner’s sales force or any other agents or employees of Partner are agents or employees of Medivation or subject to Medivation’s direction and control. Partner shall have sole authority over the terms and conditions of employment of Partner’s sales force, including their selection, management compensation (including incentive plans) and discharge.

(g) Training.

(i) Partner Training. Partner shall develop and provide product training programs and materials for Co-Promotion Products to ensure a consistent, focused promotional strategy. Partner shall provide product training for Co-Promotion Product to the Medivation Sales Force. Partner shall only conduct one (1) Co-Promotion Product training (“Training Program”) for Medivation personnel. The location and duration of such one (1) Training Program shall be determined in accordance with the Shared Territory Commercialization Plan unless otherwise agreed upon by the Parties. Partner shall not be obligated to provide any training for any Medivation personnel who do not attend such Training Program, other than as expressly set forth in this Section 5.11(g). On an as-needed basis, Partner

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shall provide ongoing training relating to Co-Promotion Products for the Medivation Sales Force Trainers who will train any additional or replacement Medivation Sales Representatives to the same standard as the Medivation Sales Representatives trained by Partner. All travel and lodging and other expenses for the Medivation Sales Force to attend the Training Program will be paid by Medivation. In addition, Medivation will reimburse Partner for [*] related to [*]. Except as provided in this Section 5.11(g)(i), the implementation of all ongoing training programs for the Medivation Sales Force will be the responsibility of Medivation and at its sole expense. In any event, Medivation shall be responsible, at its sole expense, for training the Medivation Sales Force on general business and regulatory topics, including, without limitation, general sales training, computer training, call management training, Medivation car policy, expense reporting and human resources policies.

(ii) Partner shall own all right to all training programs and materials in all formats (print, video, audio, digital, computer) including without limitation, all applicable copyrights, trademarks, program names, domain names and Internet sites, but in all cases excluding the Medivation name and logo.

(iii) Each member of the Medivation Sales Force Detailing Co-Promotion Products shall have successfully completed Partner’s Training Program for such Product (either as provided by Partner or by one (1) of the Medivation Sales Force Trainers who has received training by Partner or another Medivation Sales Force Trainer) prior to conducting any Details of such Product. A member of the Medivation Sales Force shall have successfully completed the Training Program if he or she has [*] at least [*] on [*] that [*] the [*] as Partner requires of its own Sales Representatives at the time such Training Program is conducted. Each member of the Medivation Sales Force may take a [*] that makes up the Training Program [*]. If after the [*] such individual has not [*] at least [*] on [*] as Partner requires of its own Sales Representatives at the time, under no circumstances can such individual Detail the Co-Promotion Product. For the avoidance of doubt, unless Partner’s prior consent has been obtained, no member of the Medivation Sales Force may promote the Co-Promotion Product or discuss disease concepts with any medical professional, until after both (x) the First Commercial Sale of the Co-Promotion Product in the U.S. and (y) he or she has successfully completed the Training Program.

(h) Returns; Customer Support. Partner shall be responsible for handling all returns of any Co-Promotion Product. If Co-Promotion Product is returned to Medivation, Medivation shall promptly ship such Co-Promotion Product to Partner. Medivation, if requested by Partner, shall advise the customer who made the return that the Co-Promotion Product has been returned to Partner. Partner shall be responsible for providing customer support, handling medical queries, and responding to product and medical complaints relating to Co-Promotion Product.

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(i) Termination.

(i) Medivation may terminate its Co-Promotion of a particular Co-Promotion Product in the Shared Territory upon not less than [*] days prior written notice to Partner. If Medivation materially breaches its commitments or obligations relating to Co-Promotion of a Co-Promotion Product, then Partner shall have the right (in addition to any other rights it has under this Agreement) to terminate Medivation’s rights to Co-Promote such Co-Promotion Product upon prior written notice, which termination shall be effective on the [*] day following such notice if Medivation has not cured, (or commenced a plan to cure where such breach is not curable in such [*] day period provided that if such breach is not cured within [*] days, then such termination shall be effective on the [*] day) its breach within such [*] day period. Upon any termination of Medivation’s rights to Co-Promote a Co-Promotion Product under this Section 5.11(i)(i),

(1) the license granted to Medivation pursuant to Section 7.2 with respect to Co-Promoting such Co-Promotion Product shall terminate;

(2) with respect to such Co-Promotion Product, Medivation’s rights and obligations under Sections 5.10 and 5.11 shall terminate except for Sections 5.11(j)(ii), (iii) and (iv);

(3) the JCC shall not allocate any Co-Promotion responsibilities to Medivation under Section 2.6(b)(vii) for such Co-Promotion Product;

(4) Partner shall have final say regarding decisions on the Field Force Detailing Plan and deployment of medical scientific liaisons at the JCC for such Co-Promotion Product; and

(5) all other provisions of this Agreement would remain in full force and effect, including, without limitation, Medivation’s share of Operating Profits (Losses) under Section 8.2.

(ii) Partner and Medivation shall reasonably cooperate to transition to Partner Medivation’s Co-Promotion activities with respect to the terminated Co-Promotion Product(s) so as to minimize disruption to sales activity and Medivation shall withdraw its Sales Representatives from such Co-Promotion activities in a professional manner.

(j) Regulatory Compliance

(i) Each of Medivation and Partner shall reasonably cooperate with the other Party in its efforts toward ensuring that all government reporting (including price and gift reporting) by either Party, and all sales, marketing and promotional practices in respect of each Co-Promotion Product meet the standards required by (A) Applicable Laws in the Shared Territory, (B) any settlement or judgment to which either Party may be subject from time to time (including in the case of Partner, the Corporate Integrity Agreement, dated May 11, 2004, (“Partner CIA”) between Partner and the Office of Inspector General (“OIG”)), (C) applicable

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guidelines concerning the advertising of prescription drug products, the OIG’s Compliance Guidance Program issued in April 2003 (the “2003 OIG Guidance”), the Pharmaceutical Research and Manufacturers of America (“PhRMA”) Code on Interactions with Healthcare Professionals, as hereafter amended from time to time (the “PhRMA Code”), the PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, and the standards set forth by the Accreditation Council for Continuing Medical Education relating to educating the medical community in the U.S. (“ACCME Standards”), (D) the Prescription Drug Marketing Act of 1987, as amended, and the rules, regulations and guidelines promulgated thereunder (the “PDM Act”), (E) federal, state and local agencies and all payor “fraud and abuse”, and consumer protection and false claims statutes and regulations, including the Medicare and State Health Programs Anti-Kickback Law (42 U.S.C. §1320a-7b(b)) and the “Safe Harbor Regulations” which are found at 42 C.F.R. §1001.952 et seq., (F) the FCPA, (G) to the extent not inconsistent with the foregoing, either of Medivation’s or Partner’s written policies regarding ethical business practices (including in the case of Partner, the [*] and the [*]), and (H) Partner’s policy on continuing medical education.

(ii) Each of Medivation and Partner shall reasonably cooperate with the other Party to provide the other Party access to any and all information, data and reports required in order to comply with the relevant provisions of the Medicare Modernization Act (“MMA”) and any other Applicable Laws, including without limitation, state and federal reporting requirements, in a timely and appropriate manner. Partner shall ensure that its reporting to the Centers for Medicare and Medicaid Services and other federal and state healthcare programs related to the Co-Promotion Products is true, complete and correct in all material respects; provided however, that Partner shall not be held responsible for submitting erroneous reports if such deficiencies result from information provided by Medivation which itself was not true, complete and correct.

(iii) Medivation shall endeavor to prepare and provide to Partner any data or other information covered by this Section 5.11(j), and/or required to be disclosed or provided pursuant to Applicable Laws in accordance with methodologies specified by Partner, and shall advise Partner if there is any respect in which it has been unable to do so. If Medivation has a question about whether a specific transaction or other event needs to be reported to Partner pursuant to this Section 5.11(j), Medivation’s obligation shall be satisfied by delivery of a true, complete and correct report of such transaction or other event, without a determination as to the proper reporting or legal characterization of such matter.

(iv) Partner shall provide to Medivation the relevant portion of any submission containing information provided by Medivation pursuant to this Section 5.11(j) that Partner has submitted to any Governmental Authority in respect of reporting of financial expenditures related to marketing and promotional practices, but not including any report made under the Partner CIA or any other Corporate Integrity Agreement with the OIG to which Partner may be a party. Partner further agrees, to the extent reasonably practicable, to provide Medivation with an opportunity to review the relevant portion of such submission prior to submission to the applicable Governmental Authority if the information contained therein is

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inconsistent with the information provided by Medivation and to consider in good faith any reasonable requests by Medivation with respect thereto. In any event, Partner agrees to seek confidential treatment of any such information related to Medivation that it submits to any Governmental Authority to the extent Partner seeks the same treatment for information that Partner has submitted to such Governmental Authority and to the extent permitted under any Applicable Laws.

(v) Medivation and Partner shall confer with each other on a regular basis to discuss and compare their respective procedures and methodologies relating to each Party’s compliance to any Applicable Laws and the guidelines described in Section 5.11(j)(i) or fulfillment of any other obligation contained in this Section 5.11(j). In the event that the Parties have different understandings or interpretations of this Section 5.11(j) or of the applicability of, or standards required by, any Applicable Laws, then the Parties shall confer and seek to reach common agreement on such matters.

(vi) Each Party agrees that:

(1) it will instruct its Sales Representatives to use, and will use commercially reasonable efforts to train and monitor its Sales Representatives to ensure that such Sales Representatives use, only Promotional Materials, the Samples, and literature approved for use under Section 5.11(b) and (c) for the promotion of the Products in the Shared Territory;

(2) it will instruct its Sales Representatives not to misbrand, change, alter or adulterate any Promotional Materials and Samples supplied to it in any way prior to or during their distribution or use; and

(3) it will instruct its Sales Representatives to do, and will use commercially reasonable efforts to train its Sales Representatives to do, and will establish appropriate internal systems, policies and procedures for the monitoring of its Sales Representatives with the goal of ensuring that such personnel do, the following:

(a) limit claims of efficacy and safety for the Co-Promotion Products to those that are (A) consistent with approved promotional claims in, and not add, delete or modify claims of efficacy and safety in the promotion of such Products in any respect from those claims of efficacy and safety that are contained in, the then effective Shared Territory Commercialization Plan, (B) consistent with Applicable Law, and (C) consistent with the Product labeling approved by the FDA;

(b) not make any changes in Promotional Materials, and use Promotional Materials and Samples within the Shared Territory only in a manner that is consistent with (A) the then effective Shared Territory Commercialization Plan, (B) Applicable Law and (C) the Product labeling approved by the FDA;

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(c) promote the Co-Promotion Products in compliance with applicable legal and professional standards that are generally accepted by the pharmaceutical industry in the applicable market, including Applicable Laws and the applicable guidelines concerning the advertising and promotion of prescription drug products described in Section 5.11(j); and

(d) not to, directly or indirectly, pay, promise to pay, or authorize the payment of any money, or give, promise to give, or authorize the giving of anything of value to any official or employee of any Governmental Authority, or to any political party, or official thereof, or to any candidate for political office (including any party, official, or candidate) for the purpose of promoting the sale or improper use of a Co-Promotion Product.

5.12 Medical Education. In the Shared Territory, Medivation shall participate with Partner in performing Medical Education Activities and shall have the right to provide the same level of Medical Education Activities support, measured as a percentage of the effort required to carry out the Medical Education Activities for each Product in the Shared Territory, as it elects to provide for the Specialty Detail Effort under Section 5.10(a) (i.e., between [*] and [*]).

ARTICLE 6

MANUFACTURE AND SUPPLY

6.1 Overview. The Parties agree to share responsibilities with respect to the manufacture and supply of Products as provided in this Article 6 under the direction of the JMC and pursuant to the Joint Manufacturing Plan. All manufacturing and supply of Products in the Field and for the Territory shall be conducted pursuant to a comprehensive, worldwide manufacturing plan (the “Joint Manufacturing Plan”) that sets forth (a) all significant work including CMC Development activities necessary to support ongoing or anticipated Non-Clinical Studies or Clinical Trials including the timeline therefor; (b) all significant work to explore alternative formulations of Products that may improve the clinical dosing regimen or other key characteristics of such Products; (c) all significant work necessary to establish capacity for and to support ongoing or anticipated Commercialization of such Products in the Territory, including the timeline therefor; (d) the anticipated tasks and responsibilities and resource allocation of each Party; (e) the annual projected Product volume to be manufactured; and (f) a corresponding Joint Manufacturing Budget for such activities. In the event of any inconsistency between the Joint Manufacturing Plan and this Agreement, the terms of this Agreement shall prevail.

6.2 Joint Manufacturing Plan.

(a) Initial Joint Manufacturing Plan. The Joint Manufacturing Plan for the first year of the Collaboration shall be developed by the JMC and approved by the JSC within [*] after the Effective Date. Such initial Joint Manufacturing Plan will to the extent determinable at

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such time include (i) all scale up, registration batch manufacture and other work necessary to support the first Regulatory Approval of the Initial Dimebon Product in the Shared Territory and Europe, and (ii) activities to explore a [*].

(b) Amendments to the Joint Manufacturing Plan. On an [*] basis (by [*] date to be determined by the JMC consistent with Partner’s standard practice for developing manufacturing plans and budgets for its own products), or more often as the Parties deem appropriate, Partner shall prepare amendments to the then-current Joint Manufacturing Plan and submit such draft amendments to the JMC for review and approval and, upon approval by the JMC, to the JSC for approval. Each such amendment shall specify, with a level of detail according to Partner’s standard practices, the items described in Section 6.1. Each amended Joint Manufacturing Plan shall contain a corresponding budget, which budget shall identify major components of costs separately for each Product (the “Joint Manufacturing Budget”). Such updated and amended Joint Manufacturing Plan shall reflect any changes, re-prioritization of activities within, reallocation of resources with respect to, or additions to the then-current Joint Manufacturing Plan. In addition, the JMC may prepare amendments to the Joint Manufacturing Plan and corresponding Joint Manufacturing Budget from time to time during the Term, in each case, in accordance with the foregoing. Once approved by the JMC and JSC, the amended Joint Manufacturing Plan and Joint Manufacturing Budget shall become effective on the date approved by the JSC (or such other date as the JSC shall so specify). Any JSC-approved amended Joint Manufacturing Plan and Joint Manufacturing Budget shall supersede the previous Joint Manufacturing Plan and Joint Manufacturing Budget.

6.3 Manufacturing Responsibilities. Subject to Sections 6.4 and 13.2, each Party shall be obligated to conduct and fund the manufacturing of Collaboration Molecules and Products in accordance with the approved Joint Manufacturing Plan and corresponding budget. Unless the Parties agree in writing upon an alternate allocation of responsibility, the Parties shall have the following rights and obligations with respect to the operational responsibilities under each Joint Manufacturing Plan:

(a) Lead Manufacturing Party. [*] shall be the lead manufacturing Party and shall have primary operational responsibility for executing the Joint Manufacturing Plan as in effect from time to time for the Territory.

(b) Manufacture and Supply of Product. Partner shall be responsible for the manufacturing, supply and distribution of Product, including active pharmaceutical ingredient and other components of Product, to be used for Commercialization. Subject to Section 2.7(b), [*] shall include in the Joint Manufacturing Plan a projected Product launch volume to support the First Commercial Sale for the Shared Territory (“Launch Product Volume”) that is (i) consistent with [*] then-current standard practice of inventory building for product launches, which standard practice as of the Signing Date is to maintain [*] of the then annual projected demand of active pharmaceutical ingredient and [*] of the annual projected demand of finished goods (“Launch Product Volume Criteria”) or (ii) if [*] decides in its good faith judgment that such then-current Launch Product Volume Criteria should not be applied, then its good faith

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estimate of such Product launch volume. The Parties acknowledge that the projected Product volume included in a Joint Manufacturing Plan is a good faith estimate and that actual Product volume manufactured may differ from such projected Product volume due to changes in demand.

(c) Manufacture and Supply of Clinical Product. [*] will [*] manufacture and supply the [*] for [*] until a specified time defined by the initial Joint Manufacturing Plan; thereafter [*] shall be responsible for such supply of Product. [*] agrees not to execute any agreement with a Third Party related to manufacturing of any Collaboration Molecule or Product without [*] prior consent.

(d) Preparation of CMC regulatory documents. [*] will have primary responsibility for the preparation of CMC sections of the NDA for the Products.

6.4 Allocation of Manufacturing Costs Under the Joint Manufacturing Plan.

(a) All Manufacturing Costs and costs for CMC Development activities incurred pursuant to approved Joint Manufacturing Plans for the Development of Products in the Shared Territory shall be shared by the Parties as Joint Development Costs pursuant to Section 3.2(e)(i); provided that with respect to Joint Development Costs incurred in connection with those activities described in the [*], Medivation’s share of such costs shall in no event be [*], in a given Calendar Year [*], such amounts as are indicated in the [*]. All Manufacturing Costs incurred in manufacturing commercial Product for sale in the Shared Territory shall be shared by the Parties as Joint Commercialization Costs pursuant to Section 5.5. All Manufacturing Costs and costs for CMC Development activities for the Licensed Territory to the extent not included in Joint Development Costs shall be borne solely by [*].

(b) The Parties agree that Partner may use any and all Information it receives or learns under the Collaboration, whether existing as of the Effective Date or developed for Collaboration Molecules and Products with respect to manufacturing Collaboration Molecules and Products in the Shared Territory during the Term, to Develop and Commercialize Products in the Licensed Territory.

6.5 Manufacturing Standards of Conduct. Each Party shall use Diligent Efforts to carry out the tasks assigned to it under the Joint Manufacturing Plan in a timely manner. Each Party shall conduct its activities under the Joint Manufacturing Plan in a good scientific manner and in compliance with all Applicable Laws.

6.6 Manufacturing Records and Reports. Each Party shall maintain complete and accurate records (in the form of technical notebooks and/or electronic files where appropriate) of all work conducted by it under the Joint Manufacturing Plan and all Information resulting from such work. Such records, including any electronic files where such Information may also be contained, shall fully and properly reflect all work done and results achieved in the performance of the Joint Manufacturing Plan in sufficient detail and in good scientific manner appropriate for regulatory purposes. Each Party shall have the right to review and copy such records maintained

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by the other Party at reasonable times and to obtain access to originals to the extent needed for patent or regulatory purposes or for other legal proceedings. Each Party shall provide the JMC with such reports detailing its manufacturing activities under the Joint Manufacturing Plan and the results of such activities as the JMC requests.

6.7 Subcontracts; Affiliates. Subject to Sections 6.3(c) and 7.4, each Party may perform any of its manufacturing and supply obligations under the Joint Manufacturing Plan through its Affiliates or one or more Third Party manufacturers or consultants. In the event that Partner utilizes a Third Party manufacturer, Partner agrees to use commercially reasonable efforts to [*] an [*] that may be [*] to [*] upon [*].

6.8 Transfer of Manufacturing Technology. Medivation shall transfer to Partner or a Third Party manufacturer designated by Partner and reasonably acceptable to Medivation all Medivation Know-How so that Partner or such Third Party manufacturer (as appropriate) can replicate the process employed by or on behalf of Medivation as of the Effective Date to manufacture the [*]. The costs and expenses incurred by Medivation, including without limitation any Development FTE costs, in carrying out such transfer shall be shared as a Joint Development Cost. Partner acknowledges and agrees that Medivation may condition its agreement to transfer any Medivation Know-How to a Third Party manufacturer on the execution of a confidentiality agreement between such Third Party manufacturer and Medivation that contains terms substantially equivalent to those of Article 12 of this Agreement.

ARTICLE 7

LICENSES AND EXCLUSIVITY

7.1 License to Partner under Medivation Technology. Subject to the terms and conditions of this Agreement, Medivation hereby grants Partner an exclusive, royalty-bearing, sublicensable (solely as permitted in accordance with Section 7.4) license, under the Medivation Technology to develop, make, have made, use, import, export, offer for sale, and sell Products in the Field in the Territory.

7.2 Licenses to Medivation under Partner Technology and Medivation Technology. Subject to the terms and conditions of this Agreement, Partner hereby grants Medivation:

(a) a non-exclusive, non-sublicensable (except as permitted in accordance with Section 7.4), royalty-free, fully-paid license, under the Partner Technology during the Term, to conduct any and all activities assigned to Medivation under the Joint Development Plan(s), Joint Manufacturing Plan(s) or Shared Territory Commercialization Plan(s), as applicable, and

(b) the exclusive right to Develop and Co-Promote Co-Promotion Products together with Partner in the Shared Territory in addition to any rights under the Medivation Technology (which rights shall be non-sublicensable except as permitted in accordance with Section 7.4) to conduct any and all activities assigned to Medivation under the Joint Development Plan(s), Joint Manufacturing Plan(s) or Shared Territory Commercialization Plan(s), as applicable.

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7.3 Research Licenses.

(a) Medivation grants to Partner a non-exclusive, irrevocable, royalty-free, perpetual license in the Territory, with the right to sublicense only to Affiliates (for so long as they remain Affiliates), to use for [*] any Medivation Know-How and any Medivation Confidential Information, in each case to the extent disclosed during the Term to Partner by Medivation or its Affiliates and [*]; and

(b) Partner grants to Medivation a non-exclusive, irrevocable, royalty-free, perpetual license in the Territory, with the right to sublicense only to Affiliates (for so long as they remain Affiliates), to use for all [*] any Partner Know-How and any of Partner’s Confidential Information, in each case to the extent disclosed during the Term to Medivation by Partner or its Affiliates and [*].

7.4 Sublicensing.

(a) Scope of Permissible Sublicensing. The license granted by Medivation to Partner in Section 7.1 may be sublicensed by Partner to: (i) an Affiliate of Partner without any requirement of consent, provided that such sublicense to an Affiliate of Partner shall immediately terminate if and when such party ceases to be an Affiliate of Partner or (ii) a Third Party only with the prior written consent of Medivation, provided that a sublicense may be granted to a subcontractor or consultant upon prior written notice to Medivation (x) pursuant to Sections 3.5, 4.6, 5.9 and 6.7 to perform Partner’s assigned responsibilities (but not Partner’s responsibilities to provide a field sales force in the Shared Territory) under this Agreement, the Joint Development Plan, Joint Manufacturing Plan and/or Shared Territory Commercialization Plan and (y) to conduct any of Partner’s obligations and activities with respect to Products in the Licensed Territory provided that Partner remains responsible for the work allocated to, and payment to, such subcontractors and consultants to the same extent it would if it were doing such work itself. The license granted by Partner to Medivation in Section 7.2 may be sublicensed by Medivation to a subcontractor solely pursuant to Sections 3.5, 4.6, 5.9 and 6.7 to perform Medivation’s assigned responsibilities (but not Co-Promotion activities) under this Agreement, the Joint Development Plan, the Joint Manufacturing Plan and/or the Shared Territory Commercialization Plan, upon prior written notice to Partner provided that Medivation remains responsible for the work allocated to, and payment to, such subcontractors and consultants to the same extent it would if it were doing such work itself.

(b) Sublicense and Subcontractor Agreements. Each Party shall, in each agreement under which it grants a sublicense under a license set forth in Section 7.1 or 7.2 or subcontracts its obligations pursuant to Sections 3.5, 4.6, 5.9 or 6.7 (each, a “Sublicense or Subcontractor Agreement”), require the Sublicensee or subcontractor (x) to provide the

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following to such Party: (i) [*], (ii) [*], (iii) [*] and (y) to agree to [*] regarding [*], that are [*] as those undertaken by the Parties pursuant to [*] hereof. Each Sublicense or Subcontractor Agreement shall be subject to the applicable terms and conditions of this Agreement and any Third Party Licenses sublicensed to the Sublicensee or subcontractor, as the case may be. A copy of any Sublicense or Subcontractor Agreement executed by one Party with a Third Party shall be provided to the other Party within [*] days after its execution; provided that the terms of any such Sublicense or Subcontractor Agreement may be redacted to the extent not pertinent to an understanding of a Party’s obligations or benefits under this Agreement.

7.5 Negative Covenant. Each Party covenants that it will not knowingly use or practice any of the other Party’s intellectual property rights licensed to it under this Article 7 except for the purposes expressly permitted in the applicable license grant.

7.6 No Implied Licenses. Except as explicitly set forth in this Agreement, neither Party grants to the other Party any license, express or implied, under its intellectual property rights.

7.7 Third Party Payments. The Parties acknowledge that during the Term, it may be beneficial to obtain a license under Third Party intellectual property. The Parties agree that (a) with respect to Third Party intellectual property that is [*], the Parties shall discuss whether to obtain such license with Partner having the final say and responsibility for negotiating such license after good faith consideration of Medivation’s input and (b) with respect to Third Party intellectual property that is [*], (x) [*] shall determine ([*]) whether to obtain a license to such Third Party intellectual property where such license is for the Shared Territory and if a determination is made to obtain such license, [*] shall have responsibility for negotiating such license after good faith consideration of [*] input, and (y) Partner shall have the final say on obtaining a license to such Third Party intellectual property and responsibility for negotiating such license where such license is for the Licensed Territory except in each case where such Third Party intellectual property is the subject of Section 7.7(ii) below, in which case Medivation shall have the responsibility to negotiate, after good faith consideration of Partner’s input, any licenses to such Third Party intellectual property. The Parties agree that the payments to any Third Party in respect of any such Third Party License shall be deemed a “Third Party Payment” and subject to this Section 7.7, Medivation shall be responsible for making all Third Party Payments with respect to (i) Third Party Licenses [*] and (ii) Third Party Licenses to or acquisitions of Third Party intellectual property (including published applications) [*] that [*] the [*] or [*] of the [*] for the [*] within the [*]. Any payment made by Medivation under subsection (i) or (ii) above shall not be included in Joint Commercialization Costs. Partner shall be responsible for making all other Third Party Payments with respect to any additional Third Party Licenses entered into after the Effective Date pursuant to this Section 7.7 (“Approved Third Party Payments”), subject to inclusion in Joint Commercialization Costs (in the case of Approved Third Party Payments attributable to the Shared Territory) or subject to a royalty reduction as and to the extent provided in Section 8.5(e) (in the case of Approved Third Party Payments attributable to the Licensed Territory).

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7.8 Compensation to Inventors of Medivation Patents. Medivation shall be responsible for any compensation and any other payments due to the inventors, [*], [*] or any other prior owners, of any Medivation Patents listed in Exhibit J or any corresponding patents and patent applications.

7.9 Exclusivity.

(a) Restriction. Each Party hereby covenants that, for a given country beginning on [*] until [*] (the “Restricted Period”) neither it nor its Affiliates will, directly or indirectly, by itself or with a Third Party, Commercialize, except as permitted in Section 7.9(b) or 7.9(e), any Competing Product for any indication within the Initial Indications.

(b) Partner Restricted Product. Notwithstanding Section 7.9(a), if Partner or any of its Affiliates, either through its own efforts or by acquisition, obtains ownership of or a license to, or is acquired by or otherwise merges with an entity that owns or has a license to, a Competing Product, in all such cases that would result in a violation of Section 7.9(a) above with respect to a particular country (each such Competing Product that would lead to such a violation being, a “Restricted Product”), then Partner or its Affiliates shall notify Medivation in writing no later than [*] days after (x) consummation of such transaction involving a marketed Restricted Product or (y) obtaining a Regulatory Approval from the applicable Regulatory Authority, in the case of a license or acquisition of a Restricted Product in development or a Restricted Product developed through such Party’s own efforts, whether it will elect to:

(i) divest itself of such Restricted Product in such country and notify Medivation in writing of such divestiture (it being understood that such divestiture shall be consummated within [*] months of consummation of the transaction specified in Section 7.9(b)(x) or obtaining the Regulatory Approval specified in Section 7.9(b)(y)). If Partner or its Affiliate elects to divest itself of such Restricted Product, such divestiture shall occur by an outright sale to a Third Party of all of such Party’s and its Affiliate’s rights to such Restricted Product.

(ii) pay to Medivation during the Restricted Period for such country (A) royalties on Net Sales of such Restricted Product where such country is in the Licensed Territory, calculated in [*] and (B) a share of profits resulting from sales of such Restricted Product where such country is in the Shared Territory, by including, [*] and calculating [*] of such Restricted Product in the Shared Territory; or

(iii) terminate this Agreement pursuant to Section 13.2 with respect to such country.

(c) Medivation Restricted Product. Notwithstanding Section 7.9(a), if Medivation or any of its Affiliates, either through its own efforts or by acquisition, obtains ownership of or a license to, or is acquired by or otherwise merges with an entity that owns or has a license to, a Restricted Product, then Medivation or its Affiliate shall promptly notify

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Partner in writing of such occurrence no later than [*] days after (i) consummation of such transaction involving a marketed Restricted Product or (ii) obtaining a Regulatory Approval from the applicable Regulatory Authority, in the case of a license or acquisition of a Restricted Product in development or a Restricted Product developed through its own efforts, and shall be required to divest itself of such Restricted Product in such country and notify Partner in writing of such divestiture (it being understood that such divestiture shall be consummated within [*] of consummation of the transaction specified in Section 7.9(c)(i) or obtaining the Regulatory Approval specified in Section 7.9(c)(ii)).

(d) Governmental Authority Required Divestiture.

(i) In the event that a Party (the “Acquiring Party”) acquires or is acquired by, or otherwise merges or enters into a consolidation with, a Third Party or enters into any agreement with respect to any such transaction, and the Acquiring Party is informed by a Governmental Authority that it or, if applicable, its acquiror, will be required as a condition to such transaction either to (i) divest a product that, prior to such transaction, is owned or controlled by such Third Party (an “Acquired Product”) or (ii) divest its interest in the Collaboration (such transaction referred to herein as a “Triggering Transaction”), then not later than [*] days after receipt of notice of such requirement from such Governmental Authority, the Acquiring Party shall notify the other Party in writing of such requirement and whether such Acquiring Party intends to (1) divest such Acquired Product or (2) divest its interest in the Collaboration. If the Acquiring Party notifies the other Party that it intends to divest such Acquired Product, such Acquiring Party shall have [*] following the consummation of such acquisition, merger or consolidation to divest such Acquired Product; provided, that such Acquiring Party may continue its Commercialization activities hereunder for such [*] period and provided further that it shall be in no way excused from its diligence and other obligations under this Agreement during such period.

(ii) If instead the Acquiring Party notifies the other Party that it intends to sell its interest in the Collaboration, such notice (the “Selling Notice”) shall constitute an irrevocable offer to sell such interest to the other Party as provided below. Upon receipt of the Selling Notice, the other Party shall have a period of not more than [*] days to notify the other Party in writing that either (x) it does not desire to purchase such interest (a “Notification of Non Interest”) or (y) it does desire to engage in negotiations to affect such purchase (a “Notification of Interest”), in which event, unless the applicable Governmental Authority rejects the other Party as a buyer of the Acquiring Party’s interest in the Collaboration, the Parties shall negotiate in good faith to reach an agreement within the [*] day period (the “Negotiation Period”) following the date of the Notification of Interest, with respect to the price to be paid by the other Party for such interest, and the sale of such interest shall be conditioned upon the consummation of such Triggering Transaction.

(iii) If either (x) the other Party delivers a Notification of Non Interest during such [*] day period as provided in clause (ii) above, or (y) the Parties are unable to agree in writing on the price to be paid for such interest within the Negotiation Period or the Second

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Negotiation Period (as defined in clause (v) below) and the other Party provides a Notification of Non Interest to the Acquiring Party within [*] Business Days following the expiration of such Negotiation Period or Second Negotiation Period, or (z) the applicable Governmental Authority rejects the other Party as a buyer of the Acquiring Party’s interest in the Collaboration, then the Acquiring Party shall have the right to sell its interest in the Collaboration to a Third Party without the consent or approval of the other Party and notwithstanding Section 15.5; provided that (A) such Third Party shall expressly assume in a writing delivered to the other Party all of the rights and obligations of the Acquiring Party hereunder and (B) the terms of sale shall be more favorable than those offered by the other Party to the Acquiring Party (unless no such offer has been made by the other Party); and the Acquiring Party shall have [*] (or, if shorter, such period of time as may be required by the applicable Governmental Authority(ies) for such divestiture) to sell such interest.

(iv) If the Parties are able to agree in writing on the price to be paid for the Acquiring Party’s interest in the Collaboration, unless the other Party nonetheless provides a Notification of Non Interest to the Acquiring Party within [*] days after the Parties have agreed upon a price during the Negotiation Period, the other Party shall purchase the Acquiring Party’s interest in the Collaboration at the price agreed upon by the Parties during the Negotiation Period.

(v) If, however, the other Party desires to purchase the Acquiring Party’s interest in the Collaboration, but the Parties are unable to agree upon a price therefor during the Negotiation Period, then at the written election of either Party within the [*]-Business Day period after the Negotiation Period, the Parties shall seek an outside valuation of such interest in the Collaboration and the price to be paid therefor, as set forth below, it being understood that such Third Party Valuation Panel’s findings shall not be binding on either Party, but shall be available to guide the Parties’ continuing discussions, and shall provide a floor for any further negotiations of the price to be paid for such interest in the Collaboration. Upon election by either Party to seek such an outside valuation, the Parties shall again engage in good faith negotiations for the sale of the Acquiring Party’s interest in the Collaboration, for a period of [*] days following receipt by the Parties of the findings of such Valuation Panel (the “Second Negotiation Period”).

(1) The value of the Acquiring Party’s interest in the Collaboration shall be determined by a panel of three (3) Third Party valuation experts (each, a “Valuation Expert,” and collectively, the “Valuation Panel”). Each Valuation Expert shall be an [*] or [*], who shall not have had any [*] with either Party in the [*] prior to appointment, unless the Parties agree in writing to waive this requirement. Each Party shall select one (1) such Valuation Expert, and such two (2) selected Valuation Experts shall jointly select a third Valuation Expert to serve as the Valuation Panel, provided, that no such third Valuation Expert may be a person to which either Party has a reasonable objection communicated in writing to the other Party and to such two (2) other Valuation Experts not later than [*] Business Days following notice of such appointment. The Parties shall use their best efforts to cause the appointment of the Valuation Panel to be completed within [*] days after the delivery of written notice by either Party that it desires to have the value of the interest in the Collaboration determined by the Valuation Panel.

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(2) Each Party shall submit to the Valuation Panel and to the other Party prior to any hearing, such information concerning the value of such Collaboration interest as such Party may deem appropriate together with such Party’s last best offer to the other Party concerning the valuation of such interest.

(3) The Valuation Panel shall determine the value of the Collaboration interest by [*] vote of the Valuation Panel, which value shall be between or equal to the values submitted to the Valuation Panel by the Parties pursuant to (2) above.

(vi) The closing of any purchase and sale of the Acquiring Party’s interest in the Collaboration pursuant to this Section 7.9(d) shall take place at a reasonable place and time designated by the Acquiring Party in writing on not less than [*] days’ prior written notice after the determination of the value of such interest and the price to be paid, but not earlier than the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), and the receipt of all requisite approvals from Governmental Authorities, and, if the sale has been conditioned on the consummation of such Triggering Transaction, such consummation having occurred. The Parties shall cooperate and shall promptly make such filings with and applications to such Governmental Authorities as may be required in connection with such purchase and sale.

(e) If a Party has notified the other Party in accordance with Section 7.9(b) or (c) that a Restricted Product will be divested or if Partner notifies Medivation that it will terminate this Agreement in accordance with Section 7.9(b), the Commercialization of a Restricted Product by such Party during the period from the consummation of the applicable merger, consolidation or acquisition to the consummation of such divestiture or sale or from the notice of such termination to the effective date of such termination shall not be considered a breach by such Party of its obligations under this Agreement; provided, however, that such Party shall conduct any such Commercialization using personnel (i) distinct from personnel engaged in activities under this Agreement and (ii) who are not provided, directly or indirectly, or permitted to access, any Confidential Information relating to Collaboration Molecules or Products.

ARTICLE 8

FINANCIALS

8.1 License Fee. No later than ten (10) days after the Effective Date, Partner shall pay to Medivation a non-refundable, non-creditable license fee of Two Hundred and Twenty-Five Million Dollars ($225,000,000).

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8.2 Profit Sharing in the Shared Territory. The terms and conditions of this Section 8.2 shall govern each Party’s rights and obligations with respect to Operating Profits (or Losses) relating to each Product in the Shared Territory. For clarity, Medivation shall have no right to share operating profits, and no obligation to bear any operating losses, with respect to any Product in the Licensed Territory, and Medivation shall instead be entitled to receive from Partner royalties pursuant to Section 8.5.

(a) Share of Operating Profits and Operating Losses. The Parties shall share all Operating Profits and all Operating Losses (as applicable) for each Product in the Shared Territory on the basis of sixty percent (60%) to Partner and forty percent (40%) to Medivation; provided that pursuant to Section 2.7(b)(iv), Partner shall be entitled to deduct any Excess Initial Shared Territory Commercialization Budget Amount from Medivation’s share of Operating Profits beginning with the Calendar Year for which such amount relates until Partner is reimbursed the entire amount; provided, further, that any such deduction shall in no event reduce Medivation’s share of Operating Profits (or increase Medivation’s share of Operating Losses, as the case may be) for a given Calendar Quarter by more than [*].

(i) Calculation and Payment. Within [*] days after the end of each Calendar Quarter, each Party shall provide the other Party and the JCC and JDC, as applicable, with a detailed, activity-based statement of its Joint Development Costs (the “Joint Development Cost Report”) and a detailed, activity-based statement of its Joint Commercialization Costs (or in each case an estimate of any portions thereof where actuals are not known as of such time) (together with the Joint Development Cost Report, the “Joint Cost Reports”) as well as details of any adjustments to be made to the amounts submitted in the previous Calendar Quarter in a format to be agreed-upon by the JCC and JDC, as applicable. Within [*] days after the end of the Calendar Quarter, Partner shall provide Medivation and the JSC with a written report (the “Reconciliation Report”) setting forth in a format to be agreed-upon by the Parties promptly after the Effective Date, the calculations of any Operating Profit or Operating Loss in the Shared Territory and each Party’s share of such Operating Profit or Operating Loss. Such Reconciliation Report shall include for such Calendar Quarter in the case of Medivation and corresponding Partner Quarter in the case of Partner, the (i) total Net Sales (including in reasonable detail the deductions allowed in the calculation of Net Sales), (ii) total Joint Development Costs and total Joint Commercialization Costs incurred by each Party, (iii) total aggregate Joint Development Costs and total aggregate Joint Commercialization Costs and each Party’s respective share thereof, and (iv) the net payment due from one Party to the other Party in accordance with this Section 8.2(a). Any net payment owed from one Party to the other Party shall be paid within [*] days following such reconciliation (i.e. within [*] days after the end of the Calendar Quarter) provided that if a Party disputes an amount provided in such Reconciliation Report then such disputed amount shall be reviewed by the JDC (with respect to Joint Development Cost), JCC (with respect to a Joint Commercialization Cost) or JSC (with respect to Net Sales), as applicable, and any net payment owed with respect to the undisputed amounts shall be paid within such [*] period. If requested by Medivation or Partner, any invoices or other supporting documentation for any payments to a Third Party that individually exceed [*] shall be promptly provided.

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(b) Partner Quarters/Partner Year. Each Party shall designate a finance officer to consider and adopt adjustments to the reporting and payment procedures set forth in this Section 8.2 to reasonably accommodate the fact that Partner Quarters and Partner Years differ from Calendar Quarters and Calendar Years, including to ensure that each Party is able to comply with this Agreement in a manner that is consistent with its standard operating procedure.

(c) Consistency with Accounting Treatment. The Parties acknowledge and agree that particular revenues or expenses shall not be reflected in Operating Profits or Operating Losses unless and until such revenues or expenses are recognized by such Party in accordance with US GAAP principles regularly employed by such Party with respect to the transaction(s) in question.

8.3 Regulatory Milestone Payments. Partner shall make milestone payments to Medivation based on achievement by Partner, its Affiliate or a Sublicensee (or, if applicable, by Medivation hereunder during the Term) of certain development and regulatory milestone events in the specified indications as set forth in this Section 8.3. Milestone payments shall be payable for each Product upon achievement of the applicable milestone, as described in more detail in Section 8.3(a) below.


Milestone Event	Milestone Payment for the First Product in [*]	Milestone Payment for Additional [*]
[*]	[*]	[*]

(a) Clarification. Each milestone payment in the column entitled “Milestone Payment for first Product in [*],” shall be due and owing upon the first achievement of the applicable milestone event by the first Product to achieve such event, for [*]. As used in this Section 8.3(a) “[*]” shall include [*], or any combination of the foregoing. Each milestone payment in the column entitled “Milestone Payment for Additional [*],” shall be paid upon the first achievement of the applicable milestone event by the first to occur of either

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(i) any Product for an [*] other than [*], which [*] is reasonably expected to [*] in the Territory of [*], based upon an assessment in good faith by the JCC using mutually agreed upon [*], such as [*], or (ii) any Product other than the Product as to which milestone payments were already paid under the first column, for [*]. In no event shall any of the above regulatory milestones be payable more than [*].

(b) Notice; Payment. Partner shall notify and pay to Medivation the amounts set forth in this Section 8.3 within [*] after the achievement of the applicable milestone event by Partner, its Affiliate or a Sublicensee (or, if applicable, by Medivation hereunder during the Term). Each such payment shall be made by wire transfer of immediately available funds into an account designated by Medivation. Each such payment is nonrefundable and noncreditable against any other payments due hereunder.

8.4 Sales Milestone Payments.

(a) Events. Partner shall make each of the sales milestone payments indicated below to Medivation when aggregate Net Sales of all Products across all indications in the Territory in a Partner Year first reach the dollar values indicated below.


Aggregate Net Sales		Payment
[*]		[*]

Each milestone in this Section 8.4(a) shall be paid only once. The maximum total amount of payment to Medivation pursuant to this Section 8.4(a) shall be [*].

(b) Notice; Payment. Partner shall notify and pay to Medivation the amounts set forth in Section 8.4(a) with respect to a Partner Year less, pursuant to Section 2.7(b)(iv), any Excess Initial Shared Territory Commercialization Budget Amount that has not been deducted from Medivation’s share of Operating Profits pursuant to Section 8.2, within [*] days after the end of the Calendar Year during which the applicable milestone event has been achieved; provided, further, that the foregoing deduction shall in no event reduce any payment under this Section 8.4 by more than [*]. Each such payment shall be made by wire transfer of immediately available funds into an account designated by Medivation. Each such payment is nonrefundable and noncreditable against any other payments due hereunder.

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8.5 Royalties.

(a) Licensed Territory. Partner shall pay to Medivation non-refundable, non-creditable royalties on the amount of Net Sales of each Product in the Licensed Territory, as calculated by multiplying the applicable royalty rates set forth below by the corresponding amount of incremental Net Sales in the Licensed Territory of such Product in the Partner Year.


Net Sales in the Licensed Territory (Per Product)		Royalty Rate
Portion less than or equal to [*]		[*]
Portion greater than [] and less than or equal to []		[*]
Portion greater than [] and less than or equal to []		[*]
Portion greater than [*]		[*]

By way of example, if the aggregate Net Sales of a Product in the Licensed Territory in a particular Partner Year is [*], the amount of royalties payable hereunder shall be as follows:

[*]

(b) Know-How Royalties. Notwithstanding Section 8.5(a), in any country in the Licensed Territory where, at the time of sale, (x) there is neither (i) a Valid Claim of a Collaboration Patent that would be infringed, absent a license, by the manufacture, use or sale of a particular Product at the time of sale of such Product nor (ii) any Regulatory Exclusivity with respect to such Product or (y) a Generic Product is being sold in such country, Partner shall owe royalties under Section 8.5(a) (as applicable to such country) on the Net Sales of such Product in such country at rates that are [*] of the rates otherwise payable under such Section 8.5(a) for the remainder of the Royalty Term, such reduction to be prorated appropriately for the then-current Partner Quarter. The Parties agree and acknowledge that the payment of royalties by Partner to Medivation for sales in a country in which there is no Valid Claim of a Collaboration Patent covering the applicable Product shall represent consideration for the license to Medivation Know-How granted by Medivation to Partner in Section 7.1.

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(c) Royalty Term. Royalties due under this Section 8.5 with respect to a particular Product in a particular country in the Licensed Territory will commence upon the First Commercial Sale of such Product in such country and end on the date on which all of the following are true: (i) such Product is no longer covered by a Valid Claim of a Collaboration Patent in such country, (ii) no Regulatory Exclusivity exists for such Product in such country, and (iii) a Generic Product is being sold in such country (such period, the “Royalty Term”). Following the end of the Royalty Term, on a country-by-country and Product-by-Product basis, Partner shall have a royalty-free, perpetual, irrevocable, worldwide license, with the right to sublicense, to the Medivation Know-How relating to such Product in such country.

(d) Backup Products. For any Backup Product, the royalty rates provided in this Section 8.5 above shall be reduced by [*].

(e) Third Party Payments. Partner shall be entitled to deduct from the royalties payable to Medivation based on Net Sales of a Product in the Licensed Territory, [*] of Approved Third Party Payments made with respect to Third Party Licenses for intellectual property of Third Parties which is necessary or useful to make, have made, use, sell, offer for sale, import or export Collaboration Molecules or Product in the Licensed Territory, provided that with respect to such useful Third Party intellectual property, the Parties have agreed that a license to such Third Party intellectual property should be obtained for use with Collaboration Molecules and Products in the Shared Territory and provided further, at no time shall the royalty rate otherwise payable to Medivation pursuant to Section 8.5(a) (as those royalty rates may be reduced pursuant to Section 8.5(b)) be reduced by more than [*]. If, but for the proviso in the preceding sentence, the deduction under this Section 8.5(e) would have reduced a royalty payment made by Partner by more than [*], then the amount of such deduction that exceeds [*] will be [*] to [*] until the [*].

(f) Royalty Payments and Reports.

(i) All royalty amounts payable to Medivation pursuant to this Section 8.5 shall be paid in U.S. dollars within [*] days after the end of each Calendar Quarter with respect to Net Sales of each Product in the Licensed Territory in the corresponding Partner Quarter. Each payment of royalties due to Medivation shall be accompanied by a statement, on a country-by-country basis, of the amount of Net Sales of each Product in Licensed Territory during the applicable Partner Quarter and a calculation of the amount of royalty payment due on such sales for such Partner Quarter. Said reports shall be kept confidential by Medivation and not disclosed to any other party, other than Medivation’s accountants which shall be obligated to keep such information confidential, and such information and reports shall only be used for purposes of this Agreement.

(ii) Inter-Company Sales. Sales between or among Partner, its Affiliates or Sublicensees shall not be subject to royalties under Section 8.5. Partner shall be responsible for the payment of royalties on Net Sales by its Affiliates or Sublicensees to Third Parties.

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8.6 Notices of Termination. In the event that Partner has given Medivation any notice of termination of this Agreement under Article 13, no further payments under [*] shall become due following the date of such notice.

8.7 Taxes.

(a) Taxes on Income. Each Party shall be solely responsible for the payment of all taxes imposed on its share of income arising directly or indirectly from the collaborative efforts of the Parties under this Agreement.

(b) Tax Cooperation. The Parties agree to cooperate with one another and use reasonable efforts in accordance with applicable law to reduce value added tax or similar payments (“VAT”), Tax withholding and similar obligations on royalties, milestone payments, and other payments made under this Agreement.

(c) VAT. In the event that any VAT is owing in any jurisdiction in respect of any payment made by Partner to Medivation under this Agreement, then Partner shall pay such VAT, and (i) if such VAT is owing as a direct result of any action by Partner, including any assignment or sublicense, or any failure on the part of Partner or its Affiliates to comply with applicable Tax laws or filing or record retention requirements, that has the effect of modifying the tax treatment of the Parties hereto, then the payment in respect of which such VAT is owing shall be made without deduction for or on account of such VAT to ensure that Medivation receives a sum equal to the sum which it would have received had such VAT not been due or (ii) otherwise, such payment shall be made after deduction of such VAT. Any increase in payments to Medivation under this Section 8.7(c) shall reflect only the incremental increase in VAT directly resulting from clause (i) above. In the event that any VAT is owing in any jurisdiction in respect of any such payment, Medivation will provide to Partner tax invoices showing the correct amount of VAT in respect of such payments hereunder.

(d) Withholding Taxes. To the extent Partner is required to deduct and withhold Taxes from any payment to Medivation, Partner shall pay the amounts of such Taxes to the proper Governmental Authority in a timely manner and promptly transmit to Medivation an official Tax receipt or other evidence of timely payment sufficient to enable Medivation to claim the payment of such Taxes as a deduction or Tax credit. Medivation shall provide Partner any Tax forms that may be reasonably necessary in order for Partner to not withhold Tax or to withhold Tax at a reduced rate under an applicable bilateral income tax treaty and Partner shall apply the reduced rate of withholding, or dispense with withholding, as the case may be, provided that Partner has received evidence, in a form satisfactory to Partner, of Medivation’s delivery of all applicable forms (and, if necessary, its receipt of appropriate governmental authorization) at least [*] days prior to the time the applicable payment is due. Each Party shall provide the other with reasonable assistance to enable the recovery, as permitted by Applicable Law, of withholding Taxes, value added Taxes, and similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding Tax or value added Tax.

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(i) Taxes Resulting From Partner Action. If Partner is required to make a payment to Medivation subject to a deduction or withholding of Tax, then (A) if such deduction or withholding of Tax obligation arises as a result of any action by Partner, including an assignment of this Agreement, or any failure on the part of Partner to comply with Applicable Law, that has the effect of modifying the Tax treatment or increasing the Tax of Medivation (a “Partner Withholding Tax Action”), then subject to paragraph (ii) below, the payment by Partner (in respect of which such deduction or withholding of Tax is required to be made) shall be increased by the amount necessary (the “Additional Tax”) to ensure that Medivation receives an amount equal to the amount that it would have received had no such Partner Withholding Tax Action occurred, and (B) the Additional Tax shall be deducted and withheld by Partner from the payment made by Partner to Medivation. The Additional Tax, along with any other Tax deducted and withheld from the payment made by Partner, shall be timely remitted to the proper Governmental Authority for the account of Medivation in accordance with Applicable Law.

(ii) Tax Credits and Tax Repayments. If any Additional Tax is paid pursuant to Section 8.7(d)(i) and Medivation determines that it has derived full use and benefit from a credit against the payment of any Tax for all or any portion of such Additional Tax, or it receives a repayment of all or any portion of such Additional Tax, then Medivation shall, to the extent that it can do so without prejudice to the retention of the amount of such credit or repayment, pay to Partner an amount that will leave Medivation (after such payment) in no worse after-Tax financial position than it would have been in had it not made the payment to Partner.

(iii) Clawback of Tax Credits and Tax Repayments. If Medivation makes a payment to Partner pursuant to Section 8.7(d)(ii) and Medivation subsequently determines that the credit or repayment in respect of which such payment was made was not available, or upon final settlement with an applicable Governmental Authority it is determined that the credit or repayment in respect of which such payment was made was not available, Partner shall reimburse Medivation the amount that Medivation determines necessary to place Medivation in the same after-Tax financial position as it would have been in had it not made the payment to Partner pursuant to Section 8.7(d)(ii).

8.8 Blocked Currency. In each country where the local currency is blocked and cannot be removed from the country, royalties accrued on Net Sales in that country shall be paid to Medivation in the equivalent amount in U.S. dollars.

8.9 Foreign Exchange. Conversion of sales or expenses recorded in local currencies to U.S. dollars will be performed in a manner consistent with each Party’s normal practices used to prepare its audited financial statements for external reporting purposes, provided that such practices use a widely accepted source of published exchange rates.

8.10 Late Payments. Any amount required to be paid by a Party hereunder which is not paid on the date due but is paid on a date that is [*] days or fewer past such date shall bear interest at a rate equal to the U.S. Prime Rate effective for the date payment was due, as reported by The Wall Street Journal, plus [*]. Any amount required to be paid by a Party hereunder which

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is paid on a date that is [*] days or more past the date due shall bear interest at a rate equal to the U.S. Prime Rate effective for the date payment was due, as reported by The Wall Street Journal, plus [*], computed for [*]. Such interest shall be computed on the basis of a year of 360 days for the actual number of days payment is delinquent.

8.11 Financial Records; Audits. Each Party shall maintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the amount to be reimbursed, pursuant to Section 8.2 with respect to Joint Development Costs, Joint Commercialization Costs or other amounts to be reimbursed or shared hereunder incurred or generated (as applicable) by such Party, achievement of sales milestones, royalty payments and other compensation payable under this Agreement, as well as recording and tracking of Details to be provided in the Shared Territory. Upon reasonable prior notice, such records shall be open during regular business hours for a period of [*] years from the date of rendering of the report to which the audit relates for examination at the auditing Party’s expense, and not more often than once each Calendar Year, by an independent certified public accountant selected by the auditing Party and reasonably acceptable to the audited Party for the sole purpose of verifying for the auditing Party the accuracy of the financial reports or sales milestone notices furnished by the audited Party pursuant to this Agreement or of any payments made, or required to be made, by or to the audited Party to the other pursuant to this Agreement. The audited Party may require such accountant to enter into a reasonably acceptable confidentiality agreement and any such auditor shall not disclose the audited Party’s Confidential Information to the auditing Party, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by the audited Party or the amount of payments due by the audited Party under this Agreement. The opinion of said independent accountant regarding such reports and related payments shall be binding on the Parties, other than in the case of manifest error. Any amounts shown to be owed but unpaid, or overpaid and in need of reimbursement, shall be paid or refunded (as the case may be) within [*] days after the accountant’s report, plus interest (as set forth in Section 8.10) from the original due date (unless challenged in good faith by the audited Party in which case any dispute with respect thereto shall be resolved in accordance with Article 14). The auditing Party shall bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment by, the audited Party that resulted from a discrepancy in a report that the audited Party provided to the other Party during the applicable audit period, which underpayment or overpayment was more than [*] of the amount set forth in such report, in which case the audited Party shall bear the full cost of such audit.

8.12 Manner and Place of Payment. All payments owed under this Agreement shall be made by wire transfer in immediately available funds to a bank and account designated in writing by Medivation or Partner (as applicable) at least five (5) Business Days before such payment is due.

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ARTICLE 9

INTELLECTUAL PROPERTY

9.1 Ownership of Inventions. Each Party shall own all inventions and Information generated solely by it and its Affiliates and their respective employees, agents and independent contractors in the course of conducting such Party’s activities under this Agreement (collectively, “Sole Inventions”). All inventions and Information that are generated jointly by employees, Affiliates, agents, or independent contractors of each Party in the course of performing activities under this Agreement (collectively, “Joint Inventions”) shall be owned jointly by the Parties in accordance with joint ownership interests of co-inventors under U.S. patent laws (that is, each Party shall have full rights to license, assign and exploit such Joint Inventions (and any patents arising therefrom) anywhere in the world, without any requirement of gaining the consent of, or accounting to, the other Party), subject to the licenses granted herein and subject to any other intellectual property held by such other Party. Inventorship shall be determined in accordance with U.S. patent laws.

9.2 Disclosure of Inventions. Each Party shall promptly disclose to the other all Sole Inventions or Joint Inventions, including all invention disclosures or other similar documents submitted to such Party by its, or its Affiliates’, employees, agents or independent contractors describing such Sole Inventions or Joint Inventions. Such Party shall also respond promptly to reasonable requests from the other Party for more Information relating to such inventions.

9.3 Prosecution of Patents.

(a) Medivation Patents. Except as otherwise provided in this Section 9.3(a), as between the Parties, Medivation shall have the sole right and authority to prepare, file, prosecute (including any oppositions, interferences, reissue proceedings, reexaminations and post-grant proceedings) and maintain the Medivation Patents in any jurisdiction in the Territory. Medivation shall provide Partner reasonable opportunity to review and comment on such filing and prosecution efforts regarding such Medivation Patents in the Territory reasonably prior to any submissions with applicable patent authorities. Medivation shall provide Partner with a copy of material communications from any patent authority in the Territory regarding such Medivation Patents, and shall provide drafts of any material filings or material responses to be made to such patent authorities a reasonable amount of time in advance of submitting such filings or responses so that Partner may have an opportunity to review and comment thereon. If Medivation determines in its sole discretion to abandon, cease prosecution or not maintain any Medivation Patent anywhere in the Territory, then Medivation shall provide Partner written notice of such determination at least [*] days before any deadline for taking action to avoid abandonment (or other loss of rights) and shall provide Partner with the opportunity to prepare, file, prosecute and maintain such Medivation Patent in the Territory on behalf of Medivation. If Partner desires Medivation to file, in a particular jurisdiction in the Territory, a Medivation Patent that claims priority to (or is based on the subject matter of) another Medivation Patent, Partner shall provide written notice to Medivation requesting that Medivation file such patent application in such

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jurisdiction. If Partner provides such written notice to Medivation, Medivation shall either (i) file and prosecute such patent application and maintain any patent issuing thereon in such jurisdiction, or (ii) notify Partner that Medivation does not desire to file such patent application and provide Partner with the opportunity to file and prosecute such patent application and maintain any patent issuing thereon on behalf of Medivation. Partner’s rights under this Section 9.3(a) with respect to any Medivation Patent licensed to Medivation by a Third Party shall be subject to the rights of such Third Party to file, prosecute, and/or maintain such Medivation Patent. Medivation shall be responsible for all costs incurred by it in the course of preparing, filing, prosecuting and maintaining the Medivation Patents, without reimbursement by Partner, and such costs shall not be included in Joint Development Costs or Joint Commercialization Costs. If Partner assumes responsibility for any Medivation Patents pursuant to clause (ii) above, then all costs incurred by Partner in the course of preparing, filing, prosecuting and maintaining such Medivation Patents shall be borne by Partner, without reimbursement by Medivation, and such costs shall not be included in Joint Development Costs or Joint Commercialization Costs.

(b) Partner Patents. Partner shall have the sole right and authority to prepare, file, prosecute (including any oppositions, interferences, reissue proceedings reexaminations and post-grant proceedings) and maintain the Partner Patents in any jurisdiction in the Territory. Partner shall provide Medivation reasonable opportunity to review and comment on such prosecution efforts regarding Partner Patents in the Territory that are directed to Partner’s Sole Inventions. Partner shall provide Medivation with a copy of material communications from any patent authority in the Territory regarding such Partner Patents that are directed to Partner’s Sole Inventions, and shall provide drafts of any material filings or material responses to be made to such patent authorities a reasonable amount of time in advance of submitting such filings or responses. Partner shall be responsible for all costs incurred by it in the course of preparing, filing, prosecuting and maintaining the Partner Patents, without reimbursement by Medivation, and such costs shall not be included in Joint Development Costs or Joint Commercialization Costs.

(c) Joint Patents. With respect to any potentially patentable Joint Invention, Partner shall have the first right, but not the obligation, to prepare patent applications based on such Joint Invention, to file and prosecute (including any oppositions, interferences, reissue proceedings, reexaminations and post-grant proceedings) such patent applications, and to maintain any patents issuing therefrom (any such patent application and patents, a “Joint Patent”), in any jurisdictions throughout the Territory. Each Party shall bear its own internal costs in respect of the filing prosecution of and maintenance Joint Patents by Partner. Out-of-pocket costs incurred in respect of the filing, prosecution and maintenance of Joint Patents by Partner shall be borne [*] by [*] and [*] by [*] throughout the Territory. Partner shall provide Medivation reasonable opportunity to review and comment on such prosecution efforts regarding such Joint Patent, and Medivation shall provide Partner reasonable assistance in such efforts. Partner shall provide Medivation with a copy of all material communications from any patent authority in the applicable jurisdictions regarding the Joint Patent being prosecuted by Partner, and shall provide drafts of any material filings or material responses to be made to such patent authorities a reasonable time in advance of submitting such filings or responses. Each Party

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agrees to provide the other Party with all information necessary or desirable to enable the other Party to comply with the duty of candor/duty of disclosure requirements of any patent authority. If Partner declines to file, or if either Party subsequent to filing determines that it is no longer interested in supporting the continued prosecution or maintenance of a particular Joint Patent in a country or jurisdiction: (i) then the disclaiming Party shall provide the other Party written notice of such determination at least [*] days before any deadline for taking action to avoid abandonment (or other loss of rights) and shall provide the other Party with the opportunity to prepare, file, prosecute and maintain such Joint Patent; and (ii) the disclaiming Party shall, if requested in writing by the other Party, assign its ownership interest in such Joint Patent in such country or jurisdiction to the other Party for no additional consideration (except in the case of a U.S. patent or patent application that is tied by a terminal disclaimer to another patent right owned by the disclaiming Party). If such assignment is effected (or if it is not effected because of a terminal disclaimer), any such Joint Patent shall thereafter be deemed a Medivation Patent in the case of assignment to Medivation, or a Partner Patent that is not a Collaboration Patent in the case of assignment to Partner; provided, however, that (x) in the case of an assignment to Partner, Medivation shall retain a non-exclusive, royalty-free perpetual license under such Joint Patent, subject to Partner’s exclusive right to exploit such Joint Patent for Products in the Field in the Territory during the Term of the Agreement; and (y) in the case of an assignment to Medivation, Partner shall retain a non-exclusive, royalty-free (provided that for Products in the Field in the Licensed Territory, the provisions of Section 8.5 shall apply during the Term of the Agreement) perpetual license under such Joint Patent. In the event a Party elects to disclaim its interest in a Joint Patent, the costs incurred with respect to such Patent after the date of such disclaimer shall thereafter be borne exclusively by the other Party, without reimbursement or credit.

(d) Cooperation in Prosecution and Extensions. Each Party shall provide the other Party all reasonable assistance and cooperation in the patent prosecution efforts provided above in this Section 9.3, including providing any necessary powers of attorney and executing any other required documents or instruments for such prosecution. Partner shall consult with the Medivation before applying for or obtaining any patent term extension or related extension of rights, including supplementary protection certificates and similar rights for any Collaboration Patents. Medivation shall provide reasonable assistance to Partner in connection with obtaining any such extensions for the Collaboration Patents. To the extent reasonably and legally required in order to obtain any such extension in a particular country, each Party shall make available to the other a copy of the necessary documentation to enable such other Party to use the same for the purpose of obtaining the extension in such country.

(e) Patents Licensed from Third Parties. Each Party’s rights under this Section 9.3 with respect to any Collaboration Patent or other Partner Patent licensed to a Party by a Third Party shall be subject to the rights of such Third Party to prosecute, maintain and extend such Collaboration Patent or other Partner Patent.

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9.4 Infringement of Collaboration Patents by Third Parties.

(a) Notification. If there is any infringement, threatened infringement, or alleged infringement of the Collaboration Patents on account of a Third Party’s manufacture, use, offer for sale, or sale of a product in the Field (in each case, a “Product Infringement”), then each Party shall promptly notify the other Party in writing of any such Product Infringement of which it becomes aware, and shall provide evidence in such Party’s possession demonstrating such Product Infringement.

(b) Enforcement Rights.

(i) Medivation Patents and Joint Patents. Subject to Section 9.4(e) and the remainder of this Section 9.4(b)(i), Partner shall have the first right, but not the obligation, to bring an appropriate suit or other action against any person or entity allegedly engaged in any Product Infringement of the Medivation Patents or the Joint Patents in the Territory (and to defend any related counterclaim), at Partner’s expense. Partner shall have a period of [*] days after its receipt or delivery of notice and evidence pursuant to Section 9.4(a), to elect to so enforce such Medivation Patent or Joint Patent in the Territory (or to settle or otherwise secure the abatement of such Product Infringement). In the event Partner does not so elect (or settle or otherwise secure the abatement of such Product Infringement), it shall so notify Medivation in writing, and Medivation shall have the right to commence a suit or take action to enforce the applicable Medivation Patents or Joint Patents with respect to such Product Infringement in the Licensed Territory, at Medivation’s expense. Each Party shall provide to the Party enforcing any such rights under this Section 9.4(b)(i) reasonable assistance in such enforcement, at such enforcing Party’s request and expense, including joining such action as a party plaintiff if required by Applicable Law to pursue such action. The enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts, and shall reasonably consider the other Party’s comments on any such efforts.

(ii) Partner Patents. Partner shall have the sole right, but not the obligation, to bring an appropriate suit or other action against any person or entity allegedly engaged in any Product Infringement of the Partner Patents. Medivation shall provide reasonable assistance to Partner in such enforcement, at Partner’s request and expense. Partner shall keep Medivation regularly informed of the status and progress of such enforcement efforts, and shall reasonably consider Medivation’s comments on any such efforts.

(c) Settlement. Without the prior written consent of the other Party, neither Party shall settle any claim, suit or action that it brought under this Section 9.4 that admits the invalidity or unenforceability of any Collaboration Patent, requires abandonment or limits the scope of any Collaboration Patent or would limit or restrict the ability of either Party to sell Products anywhere in the Territory.

(d) Expenses and Recoveries. A Party bringing a claim, suit or action under Section 9.4(b)(i) or 9.4(b)(ii) against any person or entity engaged in Product Infringement of the Collaboration Patents shall be solely responsible for any expenses incurred by such Party as a result of such claim, suit or action, and such expenses shall not be included in Joint Development

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Costs or Joint Commercialization Costs. If such Party recovers monetary damages from such Third Party in such suit or action, such recovery shall be allocated first to the reimbursement of any expenses incurred by the Parties in such litigation (including, for this purpose, a reasonable allocation of expenses of internal counsel), and any remaining amount shall be distributed as follows: (i) to the extent the recovery related to infringing activities in the Shared Territory, [*] to Partner and [*] to Medivation, and (ii) to the extent the recovery is related to infringing activities in the Licensed Territory, (x) if Partner enforces, [*] provided such amount shall be [*], and (y) if Medivation enforces, [*].

(e) Patents Licensed from Third Parties. Each Party’s rights under this Section 9.4 with respect to any Collaboration Patent licensed to the other Party by a Third Party shall be subject to the rights of such Third Party to enforce such Collaboration Patent and/or defend against any claims that such Collaboration Patent is invalid or unenforceable.

9.5 Defense of Collaboration Patents.

(a) If any Party receives notice by counterclaim, declaratory judgment action or otherwise, alleging the invalidity or unenforceability of any Collaboration Patent, it shall bring such fact to the attention of the other Party, including all relevant information related to such claim. Where such allegation is made in an opposition, reexamination, interference or other patent office proceeding, the provisions of Section 9.3 shall apply. Where such allegation is made in a counterclaim to a suit or other action brought under Section 9.4, the provisions of Section 9.4 shall apply. Where such allegation is made in a declaratory judgment or other court action, (i) the Party who prosecuted such Medivation Patent or Joint Patent pursuant to Section 9.3 shall have the first right to defend such action at its own expense, provided that if a Party pursuant to Section 9.4 elects to bring an infringement counterclaim, the provisions of Section 9.4 shall thereafter apply; and (ii) Partner shall have the sole right, but no obligation, to defend such Partner Patent. If the Party with the first right to defend a Medivation Patent or Joint Patent elects not to defend such action, it shall so notify the other Party in writing, and the other Party shall have the right to defend such action, at the other Party’s expense. For any such action involving a Collaboration Patent, the non-defending Party shall provide to the defending Party all reasonable assistance in such defense, at the defending Party’s request and expense; and the defending Party shall keep the other Party regularly informed of the status and progress of such efforts, and shall reasonably consider the other Party’s comments on any such efforts.

(b) Without the prior written consent of the other Party, neither Party shall enter into any settlement of any claim, suit or action that it defended under this Section 9.5 that admits the invalidity or unenforceability of any Collaboration Patent, requires abandonment or limits the scope of any Collaboration Patent or would limit or restrict the ability of either Party to sell Products anywhere in the Territory.

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9.6 Defense of Infringement Actions. During the Term of this Agreement, each Party shall bring to the attention of the other Party all information regarding potential infringement or any claim of infringement of Third Party intellectual property rights in connection with the development, manufacture, production, use, importation, offer for sale, or sale of Products in the Territory. In the case of any such claim against Partner alone or against both Partner and Medivation, Partner shall be entitled to control the defense of such claim and shall be the Indemnifying Party solely for purposes of determining which Party will assume direction and control of any defense, litigation, settlement, appeal or other disposition arising in connection therewith as provided in Section 11.3. Medivation will have the right to consult with Partner concerning such claim and if Medivation is a party to the litigation, Medivation shall have the right to participate in and be represented by independent counsel at its own expense. In the case of any such claim against Medivation alone, Medivation shall have the right to control the defense of such claim and Partner shall have the right to consult with Medivation concerning such claim. This Section 9.6 shall not be interpreted as placing on either Party a duty of inquiry regarding Third Party intellectual property rights. Medivation shall be responsible for paying all Damages incurred by one or both Parties with respect to any claim of infringement in the Territory of any Third Party intellectual property (including published applications) existing as of the Signing Date that covers the manufacture of the Initial Dimebon Product or the use, sale or import of the Initial Dimebon Product for the treatment of any indication within the Field and such Damages shall not be included in Joint Development Costs or Joint Commercialization Costs. Any other Damages incurred by one or both Parties with respect to any claim of infringement of Third Party intellectual property rights pursuant to this Section 9.6 with respect to the Shared Territory shall be allocated between the Parties pursuant to Section 11.4 and with respect to the Licensed Territory shall be deemed an Approved Third Party Payment for the purposes of Section 8.5(e).

9.7 Patent Marking. Partner shall, and shall require its Affiliates and Sublicensees, to, mark Products sold by it hereunder (in a reasonable manner consistent with industry custom and practice) with appropriate patent numbers or indicia to the extent permitted by applicable law and regulations, in those countries in which such markings or such notices impact recoveries of damages or equitable remedies available with respect to infringements of patents.

9.8 Personnel Obligations. Prior to beginning work under this Agreement relating to any research, Development or Commercialization of a Collaboration Molecule or a Product, each employee, agent or independent contractor of Partner or Medivation or of either Party’s respective Affiliates shall be bound by non-disclosure and invention assignment obligations that are consistent with the obligations of Partner or Medivation, as appropriate, in this Article 9, including without limitation: (a) promptly reporting any invention, discovery, process or other intellectual property right; (b) assigning to Partner or Medivation, as appropriate, all of his or her right, title and interest in and to any invention, discovery, process or other intellectual property right; (c) cooperating in the preparation, filing, prosecution, maintenance and enforcement of any patent and patent application; (d) performing all acts and signing, executing, acknowledging and delivering any and all documents required for effecting the obligations and purposes of this Agreement; and (e) abiding by the obligations of confidentiality and non-use set forth in Article 12. It is understood and agreed that such non-disclosure and invention assignment agreement need not reference or be specific to this Agreement.

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9.9 Trademarks, Corporate Logos and other Intellectual Property Rights.

(a) Partner shall be responsible for the selection, searching, clearance, filing, registration, maintenance and defense of the trademarks used to identify the Products, and all trademarks, logos, taglines, trade dress, domain names and/or indicia of origin for use in connection with the sale or marketing of Products in the Field in the Territory (the “Marks”), as well as all expenses associated therewith other than Trademark Costs. All uses of the Marks shall be reviewed by the JCC and shall comply with all Applicable Laws (including, without limitation, those laws and regulations particularly applying to the proper use and designation of trademarks in the applicable countries). Neither Party shall, without the other Party’s prior written consent, use any trademarks or house marks of the other Party (including the other Party’s corporate name), or marks confusingly similar thereto, in connection with such Party’s marketing or promotion of Products under this Agreement, except as provided in the below Section 9.9(b) or as may be expressly authorized in connection with activities under Section 5.11 and except to the extent required to comply with Applicable Laws. Partner shall own all Marks.

(b) During the Term of this Agreement, Partner grants to Medivation the non-exclusive right, free of charge, to use the Pfizer name and logo in the Shared Territory solely for the purpose of Co-Promoting the Co-Promotion Products in accordance with the terms of this Agreement, and Medivation grants to Partner the non-exclusive right, free of charge, to use the Medivation name and logo in the Shared Territory solely for the purpose of Co-Promoting the Co-Promotion Products in accordance with the terms of this Agreement, provided that such rights shall be exercised, and all Products bearing such names and/or logos shall be manufactured in accordance with the quality standards established by the JSC. Partner shall remain the owner of the Pfizer name and logo and the trademarks and the goodwill pertaining thereto. Medivation shall remain the owner of the Medivation name and logo and the trademarks and the goodwill pertaining thereto.

ARTICLE 10

REPRESENTATIONS AND WARRANTIES; COVENANTS; HSR

10.1 Mutual Representations and Warranties. Each Party hereby represents, warrants to the other Party that as of the Signing Date and the Effective Date:

(a) It is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including, without limitation, the right to grant the licenses granted by it hereunder.

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(b)(i) It has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; (iii) it has taken all other action required by Applicable Law, its certificate of incorporation, by-laws or other organizational documents or any agreement to which it is a party or to which it may be subject required to authorize such execution, delivery and performance (other than compliance with all applicable requirements of the HSR Act) and (iv) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms.

(c) It is not a party to any agreement that would prevent it from granting the rights granted to the other Party under this Agreement or performing its obligations under this Agreement.

(d) The execution and delivery of this Agreement by it and the performance by it contemplated hereunder does not and will not violate any Applicable Laws or any order of any court or Governmental Authority, except for such violations that would not have an adverse effect on the ability of the Party to perform its obligation under this Agreement.

(e) Except for filings pursuant to the HSR Act, if any, neither the execution and delivery of this Agreement nor the performance hereof by it requires it to obtain any permits, authorizations or consents from any Governmental Authority (other than any Regulatory Approvals relating to the manufacture, use, importation or sale of any Collaboration Molecules or Products) or from any other person, firm or corporation, and such execution, delivery and performance will not result in the breach of or give rise to any right of termination, rescission, renegotiation or acceleration under, or trigger any other rights under, any agreement or contract to which it is a party or to which it may be subject that relates to Medivation Technology, Dimebon or the Initial Dimebon Product in the case of Medivation, or to Partner Technology, Dimebon or the Initial Dimebon Product, in the case of Partner.

(f) In the course of the Development of Products, such Party has not used prior to the Effective Date any employee, agent or independent contractor who has been debarred by any Regulatory Authority, or, to the best of such Party’s knowledge, is the subject of debarment proceedings by a Regulatory Authority.

10.2 Representations and Warranties by Medivation. Medivation hereby represents and warrants to Partner as of the Signing Date:

(a) It or its wholly owned subsidiary, Medivation Neurology Inc has sole legal and beneficial title to the Medivation Patents listed on Exhibit J, and sufficient legal and beneficial title or ownership to all other Medivation Technology, in each case, which title or ownership is free and clear from any mortgages, pledges, liens, security interests, conditional and installment sale agreements, encumbrances, charges or claims of any kind, such that it is able to

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grant the licenses to Partner as purported to be granted pursuant to this Agreement. Other than rights granted to contract manufacturers or other service providers to allow them to perform on Medivation’s behalf, no person, firm, corporation or other entity (including any Affiliate of Medivation) has any right, interest or claim in or to, and neither Medivation nor any of its Affiliates has entered into any agreement granting any right, interest or claim in or to, any Medivation Patents or Medivation Technology to any Third Party (including any academic organization or agency). Exhibit J lists all of the Medivation Patents that exist as of the Signing Date.

(b) Medivation has taken appropriate steps to properly record in the relevant U.S. and foreign patent offices the assignments, or other necessary documents, supporting its legal title to the Medivation Patents listed on Exhibit J.

(c) Medivation has not received any written notice from any Third Party asserting or alleging that any research or development of Collaboration Molecules or Products by Medivation or any other party prior to the Signing Date infringed or misappropriated the intellectual property rights of such Third Party.

(d) Medivation has no knowledge from which it would have reason to conclude that the Medivation Patents issued as of the Signing Date are invalid or unenforceable, and no Third Party has challenged the extent, validity or enforceability of any patents encompassed within the Medivation Patents (i) through the institution of legal proceedings in a court or of interference, nullity or similar invalidity proceedings before the U.S. Patent and Trademark Office or any analogous foreign entity or (ii) to the knowledge of Medivation, by written threat of institution of such proceedings.

(e) To Medivation’s knowledge, the research, development, manufacture, use, sale, offer for sale, and importation of the Initial Dimebon Product can be carried out in the manner contemplated as of the Signing Date without infringing any patent applications or patents owned or controlled by a Third Party (in the case of pending patent applications, were they to issue with such claims contained therein as they exist as of the Signing Date).

(f) There is no action, claim, demand, suit, proceeding, arbitration, grievance, citation, summons, subpoena, inquiry or investigation of any nature, civil, criminal, regulatory or otherwise, in law or in equity, pending (or, to the knowledge of Medivation, threatened) against Medivation or any of its Affiliates or, to the knowledge of Medivation, pending or threatened against any Third Party, in each case in connection with the Medivation Technology, the Collaboration Molecules, the Products or relating to the transactions contemplated by this Agreement.

(g) To the knowledge of Medivation, there are no activities by Third Parties that constitute infringement or misappropriation of the Medivation Technology (in the case of pending patent applications, were they to issue with such claims contained therein as they exist as of the Signing Date).

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(h) Medivation has complied with all Applicable Laws, including any disclosure requirements, in connection with the filing, prosecution and maintenance of the Medivation Patents in the Territory and no inventor has been named, or has failed to be named, on the Medivation Patents filed in the U.S. with deceptive intent.

(i) None of the inventions claimed in the Medivation Patents were developed with funding from the U.S. government or any other Governmental Authority.

(j) To the knowledge of Medivation, the conception and reduction to practice of any inventions and the use or development of any other Information within the Medivation Technology, and any and all Regulatory Materials submitted to or filed with a Regulatory Authority by Medivation or any of its Affiliates have not constituted or involved the misappropriation of trade secrets or other rights or property of any Third Party.

(k) Medivation has heretofore disclosed or made available to Partner (i) all material scientific and technical information known to it or its Affiliates relating to (A) the safety and efficacy of Dimebon and the Initial Dimebon Product, and (B) the drug quality, including stability, variability, impurities and delivery performance, of Dimebon and (ii) all material Regulatory Materials submitted to or filed with a Regulatory Authority by Medivation or any of its Affiliates and the status of all material discussions with Regulatory Authorities, in each case, in respect of Dimebon and the Initial Dimebon Product.

(l) All Development activities related to Dimebon and the Initial Dimebon Product have been conducted by Medivation, its Affiliates or, Third Parties, in each case in accordance with Applicable Law in all material respects.

(m)(i) Each Regulatory Material, including any IND, submitted or filed by Medivation or any of its Affiliates was, at the time of submission or filing, true, complete and accurate in all material respects, (ii) no serious adverse event information has come to the attention of Medivation that is materially different with respect to the incidence, severity or nature of such serious adverse events than the information that was filed as safety updates to any such Regulatory Material, and (iii) all written data summaries that were included in any such Regulatory Material based on Clinical Trials conducted or sponsored by Medivation or any of its Affiliates accurately summarize in all material respects the raw data underlying such summaries.

(n) Medivation has not received any written notice that indicates that any of the INDs for Dimebon or the Initial Dimebon Product are not currently in good standing with the FDA; Medivation has made available to Partner complete and accurate copies of all INDs and all other material documentation submitted to any Regulatory Authority by Medivation or any of its Affiliates with respect to Dimebon and the Initial Dimebon Product; and Medivation has filed with the FDA all required notices, supplemental applications and annual or other reports or documents, including adverse experience reports, with respect to each IND that are material to the continued Development of Dimebon and the Initial Dimebon Product.

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(o) Neither Medivation nor any of its Affiliates, nor any of its or their respective officers, employees, or agents has made an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the Development of Dimebon or the Initial Dimebon Product, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority with respect to the Development of Dimebon or the Initial Dimebon Product, or committed an act, made a statement, or failed to make a statement with respect to the Development of Dimebon or the Initial Dimebon Product that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto; and

(p) All manufacturing, stability testing, labeling, packaging, storing, and shipping operations conducted by Medivation and its Affiliates, and to its knowledge, by its suppliers, relating to Dimebon and the Initial Dimebon Product are currently conducted, and have been conducted with respect to clinical Development of Dimebon and the Initial Dimebon Product, in compliance in all material respects with GMPs and other Applicable Law.

10.3 Covenants.

(a) Each Party hereby covenants and agrees that as of the Effective Date until the expiration of the Term that:

(i) It shall carry out the Development and Commercialization of the Collaboration Compounds and Products and its other obligations or activities hereunder in accordance with: (A) the terms of this Agreement, the Joint Development Plan, the Joint Commercialization Plan and the Joint Manufacturing Plan, and (B) GCPs, GLPs and GMPs and all other Applicable Laws and Regulatory Approvals; and

(ii) In the course of the Development of Products, such Party will not use any employee, agent or independent contractor who has been debarred by any Regulatory Authority, or, to the best of such Party’s knowledge, is the subject of debarment proceedings by a Regulatory Authority.

(b) Additional Covenants of Medivation. Medivation covenants and agrees as follows:

For the period of time beginning on the Signing Date and until the Effective Date:

(i) except as Partner shall otherwise consent to in writing or as set forth in this Agreement, Medivation shall (A) operate its business with respect to Collaboration Molecules, Products, and Medivation Technology in the ordinary course consistent with past practice, and (B) use commercially reasonable efforts to (1) preserve intact and keep in full force and effect all Medivation Technology, and all related relationships with customers, suppliers, distributors, licensors, licensees and other Third Parties, and (2) keep available the services of its

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current employees who are involved in the research, development or commercialization of Collaboration Molecules or Products, as the case may be, in each case in the ordinary course of business consistent with past practice and in Medivation’s good faith scientific and technical judgment;

(ii) Medivation shall promptly notify Partner in writing in the event that it becomes aware that any of its representations and warranties contained in Section 10.2 are no longer true and correct; and

(iii) Medivation shall complete the proper recordation in the relevant U.S. and foreign patent offices of the assignments, or other necessary documents, supporting its legal title to the Medivation Patents listed on Exhibit J.

From the Signing Date until the expiration of the Term:

(iv) Except as required pursuant to any consent decree or agreement with any Governmental Authority or by Applicable Laws and except as otherwise provided for in this Agreement, neither Medivation nor its Affiliates shall enter into any agreement with any Third Party, whether written or oral, with respect to, or otherwise assign, transfer, license, or convey its right, title or interest in or to, the Medivation Technology, any Collaboration Molecule or Product, in each case, that is in conflict with the rights granted by Medivation to Partner under this Agreement or that would prevent it from performing its obligations under this Agreement;

(v) Medivation shall not grant any mortgage, lien, deed of trust, charge, pledge, security interest or other encumbrance or imposition with respect to any of the Medivation Patents that would prevent it from performing its obligations under this Agreement;

(vi) Medivation (A) shall not execute or otherwise permit, and shall cause its Affiliates to refrain from executing or otherwise permitting, any amendment, modification or waiver to any of the Third Party Licenses, without the prior written consent of Partner, (B) shall not make any election or exercise any right or option (or omit to take any action) which would, and shall cause its Affiliates to refrain from making any election or exercising any right or option (or omitting to take any action) which would, terminate or relinquish in whole or in part any right under a Third Party License, (C) shall comply, and shall cause its Affiliates to comply in all respects, with all of its, and its Affiliates’, obligations under the Third Party Licenses, (D) shall take, and shall cause its Affiliates to take, such actions as shall be necessary to keep in full force and effect the Third Party Licenses, and (E) shall give prompt notice to Partner, together with a detailed summary of outstanding issues if Partner so requests, of any notice received from the Third Party of any actual or alleged defaults, breaches, violations, proposed amendments or proposed modifications of, or any proposed waivers under, any of the Third Party Licenses by any of the parties thereto; and

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(vii) Upon reasonable notice from Partner, Medivation shall provide Partner and its agents and representatives with reasonable access to Information concerning the Collaboration Molecules, Products and Medivation Technology; provided that Medivation will use reasonable efforts to make available to Partner not more than [*] Business Days after the Effective Date all the Medivation Know-How that (A) exists as of the Effective Date, and (B) has not already been provided, disclosed or otherwise made available to Partner. Medivation will provide electronic copies (e.g., in Microsoft Word and/or PDF format) or paper copies of all requested Information. Such Medivation Know-How shall include but not be limited to clinical protocols, regulatory submissions, and Pharmaceutical/Manufacturing technical reports.

10.4 Disclaimer. Each Party understands that the Collaboration Molecules and Products are the subject of ongoing clinical research and development and that the other Party cannot assure the safety or usefulness of the Collaboration Molecules or Products. In addition, Medivation makes no warranties except as set forth in this Article 10 concerning the Medivation Technology, and Partner makes no warranties except as set forth in this Article 10 concerning the Partner Technology.

10.5 No Other Representations or Warranties. EXCEPT AS EXPRESSLY STATED IN SECTION 5.8(a) AND THIS ARTICLE 10, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

10.6 HSR. Promptly following signing of this Agreement (but in any event no later than [*] days thereafter), Partner shall notify Medivation whether Partner intends to make a filing under the HSR Act, and, if Partner decides to make such a filing, then Partner (or its Affiliate) and Medivation (or its Affiliate) shall use commercially reasonable efforts to (i) take all actions necessary to make the filing required under the HSR Act within [*] Business Days after the Signing Date and (ii) reply at the earliest practicable date to any requests for information received by either Party from the United States Federal Trade Commission (“FTC”) or Antitrust Division of the United States Department of Justice (“DoJ”) pursuant to the HSR Act and (iii) cause the waiting periods under the HSR Act to terminate or expire at the earliest possible date after the filing date. The Parties shall, to the extent reasonably practicable, consult with one another prior to making any filings, responses to inquiries, or other contacts with the FTC or DoJ concerning the transactions contemplated hereby. Each Party will bear its own expenses in connection with activities under this Section 10.6, except that Partner shall be responsible for the fee due to the FTC in respect of such filing. Notwithstanding anything in this Agreement to the contrary, this Agreement shall not become effective (with the exception of Articles 1 and Sections 10.3(b) and 10.6) until such time as (a) the Parties shall have complied with all applicable requirements of the HSR Act; (b) the waiting period under the HSR Act shall have expired or earlier been terminated with respect to this Agreement; (c) any investigations opened by means of a second request or otherwise shall have been terminated, without action by a Government Authority to

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prevent the Parties from implementing the transactions contemplated by this Agreement with respect to the U.S.; and (d) no requirements or conditions shall have been formally requested or imposed by the FTC or the DoJ in connection therewith which are not reasonably and mutually satisfactory to the Parties (collectively, the “HSR Conditions” and the date upon which the HSR Conditions are met shall be referred to as the “Effective Date”). For clarity, achieving the HSR Conditions shall be the sole condition precedent to this entire Agreement coming into effect. In the event that the HSR Conditions are not met within [*] months from the date the filing required under the HSR Act is made, either Party may terminate this Agreement upon written notice to the other Party.

ARTICLE 11

INDEMNIFICATION

11.1 Indemnification by Medivation. Medivation shall defend, indemnify, and hold Partner, its Affiliates, and their respective officers, directors, employees, and agents (the “Partner Indemnitees”) harmless from and against any and all damages or other amounts payable to a Third Party claimant, as well as any reasonable attorneys’ fees and costs of litigation incurred by such Partner Indemnitees (collectively, “Partner Damages”), all to the extent resulting from claims, suits, proceedings or causes of action brought by such Third Party (“Partner Claims”) against such Partner Indemnitee that arise from or are based on: (a) a breach of any of Medivation’s representations, warranties, covenants and obligations under this Agreement; (b) the willful misconduct, recklessness or negligent acts of Medivation, its Affiliates, or the officers, directors, employees, or agents, consultants, or contractors of Medivation or its Affiliates; (c) any acts or omissions of Medivation or any of its Affiliates, agents, consultants, contractors or other Third Parties in connection with (x) the research, Development, manufacturing, storage, handling or use of Collaboration Molecules or Products before the Effective Date or (y) the research, Development, manufacturing, storage, handling, use, sale, offer for sale, and importation or Commercialization of Collaboration Molecules or Products following termination in whole or in part of this Agreement and the reversion of the applicable rights hereunder to Medivation in accordance with Section 13.5; or (d) breach of Applicable Law by Medivation or any of its Affiliates, agents, consultants or contractors other than such Partner Damages as a result of (x) the good faith prosecution, enforcement or defense of Collaboration Patents which shall be subject to Sections 9.4 and 9.5 unless covered by Section 11.1 (a), (b) or (c) or (y) non-willful infringement of Third Party intellectual property rights which shall be subject to Section 9.6 unless covered by Section 11.1(a), (b) or (c). The foregoing indemnity obligation shall not apply if the Partner Indemnitees materially fail to comply with the indemnification procedures set forth in Section 11.3, or to the extent that such Partner Damages results from: (i) a breach of any of Partner’s representations, warranties, covenants and obligations under this Agreement; or (ii) the willful misconduct, recklessness or negligent acts of Partner or its Affiliates, or the officers, directors, employees, or agents of Partner or its Affiliates. Any amounts paid as indemnification pursuant to this Section 11.1 shall be borne solely by Medivation and shall not be included in Joint Commercialization Costs or Joint Development Costs.

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11.2 Indemnification by Partner. Partner shall defend, indemnify, and hold Medivation, its Affiliates, and each of their respective officers, directors, employees, and agents, (the “Medivation Indemnitees”) harmless from and against any and all damages or other amounts payable to a Third Party claimant, as well as any reasonable attorneys’ fees and costs of litigation incurred by such Medivation Indemnitees (collectively, “Medivation Damages”), all to the extent resulting from any claims, suits, proceedings or causes of action brought by such Third Party (collectively, “Medivation Claims”) against such Medivation Indemnitee that arise from or are based on: (a) subject to Section 9.6, the Development, manufacture, storage, handling, use, sale, offer for sale, and importation of Products by Partner or its Affiliates, Sublicensees, or distributors in or with respect to the Licensed Territory; (b) a breach of any of Partner’s representations, warranties, covenants and obligations under the Agreement; (c) the willful misconduct, recklessness or negligent acts of Partner or its Affiliates, or the officers, directors, employees, agents, consultants, contractors of Partner or its Affiliates or (d) breach of Applicable Law by Partner or any of its Affiliates, agents, consultants or contractors other than such Medivation Damages as a result of (x) the good faith prosecution, enforcement or defense of Collaboration Patents which shall be subject to Sections 9.4 and 9.5 unless covered by Section 11.2 (a), (b) or (c) or (y) non-willful infringement of Third Party intellectual property rights which shall be subject to Section 9.6 unless covered by Section 11.2(a), (b) or (c). The foregoing indemnity obligation shall not apply if the Medivation Indemnitees materially fail to comply with the indemnification procedures set forth in Section 11.3, or to the extent that any Medivation Damages results from: (i) a breach of any of Medivation’s representations, warranties, covenants and obligations under this Agreement; or (ii) the willful misconduct, recklessness or negligent acts of Medivation, its Affiliates, or their officers, directors, employees, or agents. Any amounts paid as indemnification pursuant to this Section 11.2 shall be borne solely by Partner and shall not be included in Joint Commercialization Costs or Joint Development Costs.

11.3 Indemnification Procedures. The Party claiming indemnity under this Article 11 (the “Indemnified Party”) shall give written notice to the Party from whom indemnity is being sought (the “Indemnifying Party”) promptly after learning of the claim, suit, proceeding or cause of action for which indemnity is being sought (“Claim”). The Indemnified Party shall provide the Indemnifying Party with reasonable assistance, at the Indemnifying Party’s expense, in connection with the defense of the Claim for which indemnity is being sought. Subject to Section 9.6, the Indemnified Party may participate in and monitor such defense with counsel of its own choosing at its sole expense; provided, however, the Indemnifying Party shall have the right to assume and conduct the defense of the Claim with counsel of its choice. The Indemnifying Party shall not settle any Claim without the prior written consent of the Indemnified Party, not to be unreasonably withheld, unless the settlement involves only the payment of money in which case no such consent is required. The Indemnified Party shall not settle any such Claim without the prior written consent of the Indemnifying Party which shall not be unreasonably withheld.

11.4 Third Party Claims Related To Products In The Shared Territory. Subject to Sections 4.3(a), 11.1 and 11.2, damages or other amounts payable to a Third Party claimant, as well as any reasonable attorneys’ fees and costs of litigation incurred by either Party

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(collectively, “Damages”) from Third Party claims relating to the Development, manufacture, use, handling, storage, sale, promotion, use, or other disposition of any Product in or with respect to the Shared Territory during the Term for the Shared Territory (including activities under the Joint Development Plan), including without limitation Damages from claims of infringement of Third Party patent rights and claims of death or personal injury, shall be included within Joint Development Costs or Joint Commercialization Costs (as the case may be) incurred by the affected Party and Medivation shall be responsible for [*] and Partner shall be responsible for [*] of such Damages.

11.5 Insurance. Each Party shall self insure or procure and maintain insurance, including product liability insurance with minimum limits of [*] per occurrence and in the aggregate and Clinical Trials insurance with minimum limits of [*] per occurrence and in the aggregate, with respect to its activities hereunder and which are consistent with normal business practices of prudent companies similarly situated at all times during which any Product is being clinically tested in human subjects or commercially distributed or sold. It is understood that such insurance shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this Article 11. Each Party shall provide the other with written evidence of such insurance prior to the Effective Date and upon expiration of any one coverage. Partner and its Affiliates shall be an additional insured on Medivation’s products liability and clinical trials policies and be provided with a waiver of subrogation on each. Each Party shall provide the other with written notice at least thirty (30) days prior to the cancellation, non-renewal or material change in such insurance or self-insurance which materially adversely affects the rights of the other Party hereunder. All required policies of each Party shall have a minimum [*] AM Bests rating. Products liability and Clinical Trials policies shall be maintained for [*] following termination of this Agreement.

ARTICLE 12

CONFIDENTIALITY

12.1 Confidentiality. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, each Party agrees that, during the Term and for the [*] year period following the expiration or termination of this Agreement, it shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement (which includes the exercise of any rights or the performance of any obligations hereunder) any Confidential Information furnished to it by the other Party pursuant to this Agreement except for that portion of such information or materials that the receiving Party can demonstrate:

(a) was already known to the receiving Party or its Affiliate, other than under an obligation of confidentiality, at the time of disclosure by the other Party;

(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;

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(c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;

(d) is subsequently disclosed to the receiving Party or its Affiliate by a Third Party without obligations of confidentiality with respect thereto; or

(e) is independently discovered or developed by the receiving Party or its Affiliate without the aid, application, or use of Confidential Information.

Notwithstanding the definition of “Confidential Information” in Article 1, all Information generated under the Collaboration, whether generated by one or both Parties, shall be deemed the Confidential Information of both Parties. The exceptions set forth in subsections (a)-(e) above shall apply to such Confidential Information to the extent applicable. For clarity, any Information generated during or resulting from the Collaboration that is generated by a Party may be used by such Party for any purpose that does not violate Section 7.9 or Applicable Law, but the disclosure of such Confidential Information shall be governed by this Article 12.

12.2 Authorized Disclosure. Each Party may disclose Confidential Information belonging to the other Party to the extent such disclosure is reasonably necessary in the following situations:

(a) filing or prosecuting Collaboration Patents or other Partner Patents relating to any invention used in the Collaboration (subject to any applicable Third Party Licenses) in accordance with Article 9;

(b) regulatory filings and other filings with Governmental Authorities (including Regulatory Authorities), including filings with the SEC or FDA, with respect to a Product;

(c) prosecuting or defending litigation;

(d) complying with Applicable Laws, including regulations promulgated by securities exchanges;

(e) disclosure to its Affiliates, employees, agents, and independent contractors, and any Sublicensees, in each case only on a need-to-know basis and solely in connection with the performance of this Agreement, provided that each disclosee must be bound by obligations of confidentiality and non-use at least as equivalent in scope as those set forth in this Article 12 prior to any such disclosure;

(f) disclosure of the material terms of this Agreement to any bona fide potential or actual investor, investment banker, acquirer, merger partner, or other potential or actual financial partner, with the prior written consent of the other Party not to be unreasonably withheld, and provided that in connection with such disclosure, each disclosee must be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Article 12 prior to any such disclosure; and

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(g) disclosure of any Collaboration results or status reports (including data from any Clinical Trials) to any bona fide potential or actual investor, investment banker, acquirer, merger partner, or other potential or actual financial partner, with the prior written consent of the other Party not to be unreasonably withheld and provided that (i) each disclosee must be bound by obligations of confidentiality and non-use at least as equivalent in scope as those set forth in this Article 12 prior to any such disclosure, and (ii) in the case of Medivation’s disclosure, Medivation submits the contents of such proposed disclosure to Partner at least ten (10) days prior to such disclosure.

Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Sections 12.2(a), 12.2(b), 12.2(c) or 12.2(d), it will, except where impracticable, give reasonable advance notice to the other Party of such disclosure and use reasonable efforts to secure confidential treatment of such information. In any event, the Parties agree to take all reasonable action to avoid disclosure of Confidential Information hereunder.

12.3 Publicity.

(a) The Parties agree that the terms of this Agreement are the Confidential Information of both Parties, subject to disclosure permitted by Section 12.2. The Parties have agreed to make a joint public announcement of the execution of this Agreement the text of which is attached as Exhibit K, which shall be issued at a time to be mutually agreed by the Parties (but in any event no later than three (3) Business Days after such execution).

(b) After release of such press release, if either Party desires to make a public announcement concerning the terms of this Agreement, such Party shall give reasonable prior advance notice of the proposed text of such announcement to the other Party for its prior review and approval (except as otherwise provided herein), such approval not to be unreasonably withheld, except that in the case of a press release, governmental filing or other public statement required (i) by Applicable Law or legal proceedings, (ii) to be contained in financial statements of the Parties prepared in accordance with US GAAP, the disclosing Party shall (x) provide the other Party with sufficient advance notice of the text of such statement so that the other Party will have the opportunity to comment upon the statement, and the Party issuing such statement shall give due consideration any such comments in the final statement and (y) in the case of any public statement that is required by Applicable Law or legal proceedings, use commercially reasonable efforts to obtain confidential treatment of financial and trade secret information. A Party commenting on such a proposed press release shall provide its comments, if any, within five (5) Business Days after receiving the press release for review. In addition, where required by Applicable Law of the applicable securities exchange upon which a party may be listed, a Party shall have the right to make a press release announcing the achievement of each milestone under this Agreement as it is achieved, and the achievements of Regulatory Approvals as they occur,

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subject only to the review procedure set forth in the preceding sentence. In relation to the other Party’s review of such an announcement, the other Party may make specific, reasonable comments on such proposed press release within the prescribed time for commentary, but shall not withhold its consent to disclosure of the information that the relevant milestone or Regulatory Approval has been achieved and triggered a payment hereunder. Neither Party shall be required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement that has already been publicly disclosed by such Party, or by the other Party, in accordance with this Section 12.3.

(c) The Parties acknowledge that either or both Parties may be obligated to file a copy of this Agreement with the SEC or other Governmental Authorities. Each Party shall be entitled to make such a required filing, provided that it initially file a redacted copy of this Agreement approved by both Parties (“Redacted Agreement”) and requests confidential treatment of the terms redacted from this Agreement for a reasonable period of time. In the event of any such filing, each Party shall (i) permit the other party to review and comment upon such request for confidential treatment and any subsequent correspondence with respect thereto at least [*] in advance of its submission to the SEC or such other Governmental Authorities, (ii) reasonably consider and incorporate the other Party’s comments thereon to the extent consistent with the then-current legal requirements governing redaction of information from material agreements that must be publicly filed, (iii) promptly deliver to the other Party any written correspondence received by it or its representatives from such Governmental Authority, if any, with respect to such confidential treatment request and promptly advise the other Party of any other communications between it or its representatives with such Governmental Authority with respect to such confidential treatment request, (iv) upon the written request of the other Party, request an appropriate extension of the term of the confidential treatment period, where available and (v) if such Governmental Authority requests any changes to the redactions set forth in the Redacted Agreement, use commercially reasonable efforts to support the redactions in the Redacted Agreement as originally filed (to the extent consistent with the then-current legal requirements governing redaction of information from material agreements that must be publicly filed) and, to the extent reasonably practicable, not agree to any changes to the Redacted Agreement without first discussing such changes with the other Party and taking the other Party’s comments into consideration when deciding whether to agree to such changes. Each Party shall be responsible for its own legal and other external costs in connection with any such filing, registration or notification.

12.4 Publications. Neither Party shall publicly present or publish results of studies carried out under this Agreement (each such presentation or publication a “Publication”) without prior review and approval by the JCC (or its designated subcommittee) as set forth in Section 2.6(b)(vii)(5), except to the extent otherwise required by Applicable Laws and consistent with Section 12.2.

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ARTICLE 13

TERM AND TERMINATION

13.1 Term. This Agreement shall become effective on the Effective Date and, unless earlier terminated pursuant to this Article 13, shall expire on a country-by-country basis (a) in the Licensed Territory, upon expiration of the Royalty Term for all Products in such country and (b) in the Shared Territory at such time Partner is no longer selling any Products in the Shared Territory (the “Term”).

13.2 Termination by Partner at Will. Partner shall have the right to terminate this Agreement in its entirety upon [*] days prior written notice to Medivation, provided, however, that Partner shall not have any right to terminate the Agreement until eighteen (18) months following the First Commercial Sale of a Dimebon Product, unless prior to that date (a) there is clinical data for Dimebon that is [*] relative to the [*] as of the Effective Date or (b) the Parties receive a Complete Response Letter from the FDA with respect to the Initial Dimebon Product or (c) (i) [*] or (ii) [*]. Any termination pursuant to clause (b) must be made no later than [*] days after a final decision by the JSC, or a deadlock at the JSC, as to whether to pursue additional Clinical Trials or other safety or clinically-related activities (e.g., patient registries) that may be advised or required by such Complete Response Letter (such decision by the JSC to be made within [*] following the completion of all reasonably necessary consultation and discussion with FDA or other applicable Regulatory Authority as to the need, scope and design of any additional Clinical Trials or other activities that may be required as a result of such Complete Response Letter). During such [*] day notice period, Partner shall continue to perform all of its obligations under this Agreement, including performing all research, Development and Commercialization activities allocated to it pursuant to the Joint Development Plan, Joint Manufacturing Plan, and Shared Territory Commercialization Plan, respectively, then in effect in accordance with the terms and conditions of this Agreement and bearing its share of all Development Costs and Commercialization Costs incurred during such [*] day period, and Partner shall not take any action that would reasonably be expected to materially adversely affect or impair the further research, Development, and Commercialization of the Products during such [*] day period.

13.3 Termination by Either Party for Breach.

(a) Breach. Subject to Section 13.3(b), Medivation shall have the right to terminate this Agreement upon written notice to Partner if Partner materially breaches its obligations under this Agreement and, after receiving written notice from Medivation identifying such material breach by Partner in reasonable detail, fails to cure such material breach within ninety (90) days from the date of such notice (or within twenty (20) days from the date of such notice in the event such material breach is solely based upon Partner’s failure to pay any amounts due Medivation hereunder); provided that such notice of termination is given within ten (10) days after the expiration of the ninety (90) day cure period. Subject to Section 13.3(b), Partner shall have the right to terminate this Agreement upon written notice to Medivation if Medivation materially breaches its obligations (other than its obligations relating to Co-Promotion of a Co-

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Promotion Product which is subject to Section 5.11(i)(i)) under this Agreement and, after receiving written notice from Partner identifying such material breach by Medivation in reasonable detail, fails to cure such material breach within ninety (90) days from the date of such notice (or within twenty (20) days from the date of such notice in the event such material breach is solely based upon Medivation’s failure to pay any amounts due Partner hereunder); provided that such notice of termination is given within ten (10) days after the expiration of the ninety (90) day cure period.

(b) Disputed Breach. If the alleged breaching Party disputes in good faith the existence or materiality of a breach specified in a notice provided by the other Party in accordance with Section 13.3(a), and such alleged breaching Party provides the other Party notice of such dispute and its intention to seek arbitration or judgment by a court pursuant to Article 14 within such ninety (90) day period, then the non-breaching Party shall not have the right to terminate this Agreement under Section 13.3(a) unless and until an arbitrator or court, in accordance with Article 14, has determined that the alleged breaching Party has materially breached the Agreement and that such Party fails to cure such breach within ninety (90) days following such decision of such arbitrator or court (except to the extent such breach involves the failure to make a payment when due, which breach must be cured within twenty (20) days following such decision of such arbitrator or court). It is understood and agreed that during the pendency of such dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder.

13.4 Termination by either Party due to Non-occurrence of Effective Date. Either Party shall have the right to terminate this Agreement, upon written notice to the other Party, if the Effective Date has not occurred by the date provided in and pursuant to Section 10.6.

13.5 Effects of Termination of the Agreement. Upon termination of this Agreement by Partner under Section 13.2 or by Medivation under Section 13.3, the following shall apply (in addition to any other rights and obligations under Section 13.2 or otherwise under this Agreement with respect to such termination):

(a) Licenses. Other than the license granted under Section 7.3, the licenses granted in Article 7 shall terminate. Notwithstanding the foregoing, Partner hereby grants to Medivation, effective only upon such termination, a non-exclusive, worldwide, fully-paid, perpetual, irrevocable, royalty-free license, with the right to grant multiple tiers of sublicenses, under the Reverted Partner Patents and Reverted Partner Know-How to research, Develop, make, have made, use, import, export, offer for sale, and sell any Products containing Dimebon or any other Collaboration Molecules that are in active clinical development or are Commercialized as of the date of termination for the Field in the Territory and the provisions of Section 9.3(c) shall continue to apply in respect of Joint Patents, provided that if Medivation so requests in writing within [*] days after the effective date of termination, Partner will grant to Medivation an exclusive worldwide license, with the right to grant multiple tiers of sublicenses, to research, Develop, make, have made, use, import, export, offer for sale, and sell any Products containing Dimebon or any other Collaboration Molecules that are in active clinical development or are

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Commercialized as of the effective date of termination for the Field in the Territory (i) under Reverted Partner Patents on Sole Inventions, upon Medivation’s written agreement to pay all costs of prosecution and maintenance incurred after the effective date of termination, and (ii) under any other Reverted Partner Patents and Joint Patents, upon Medivation’s written agreement to pay a reasonable royalty to be negotiated in good faith by the Parties. In all cases where any element of the Reverted Partner Know-How or the Reverted Partner Patents covered by this Section 13.5(a) is licensed to Partner by a Third Party, as a condition precedent for a license to be granted to Medivation pursuant to this Section 13.5(a), Medivation shall be required to agree to pay any payments, including royalties on sales by Medivation or its Sublicensee, that accrue and become payable to such Third Party licensor after the effective date of the license to Medivation. Partner will not be obligated to grant sublicenses under this Section 13.5(a), if Partner is prohibited from granting such sublicenses under its agreement(s) with its licensor(s), but shall be required to use commercially reasonable efforts to obtain permission to grant such a sublicense from any such licensor(s).

(b) Marks. In the event notice of termination is provided after the date that is one (1) year prior to the anticipated First Commercial Sale of a Product, Partner shall, as promptly as commercially practicable, assign to Medivation all right, title and interest in and to the Marks used or to be used with such Product (excluding any such Marks that include, in whole or part, any corporate name or logo of Partner or its Affiliate or Sublicensee), including any goodwill associated therewith. For the avoidance of doubt, only those Marks which have been (i) identified as the single designated lead candidate Mark for a non-commercialized Product, or (ii) actually used in connection with a Commercialized Product, shall be assigned. Medivation shall be responsible for recording such assignment in the Territory with the appropriate Governmental Authority and will bear all costs associated with such assignment and recordation. Partner shall cooperate in facilitating such assignment and recordation by timely executing all necessary documents provided to it by Medivation.

(c) Regulatory Materials. Partner shall transfer and assign to Medivation in the form and format in which such materials are maintained by Partner in the ordinary course of business, all Regulatory Materials for Products in the Territory that are Controlled by Partner or its Affiliates. Partner shall not be required to prepare any new data, reports or information solely for purposes of transfer to Medivation and the Parties agree that any good faith failure by Partner to provide immaterial data, information, reports, records, correspondence or other materials to Medivation shall not be a breach of Partner’s obligations under this Section 13.5(c).

(d) Transition Assistance. Partner shall, at no cost to Medivation, provide reasonable consultation and assistance (“Transition Assistance”) for a period of no more than [*] after the effective date of termination for the purpose of transferring or transitioning to Medivation, (i) in the form and format in which such Partner Know-How is maintained by Partner in the ordinary course of business, all Partner Know-How not already in Medivation’s possession, and (ii) at Medivation’s request, all then-existing Third Party agreements relating solely to Collaboration Molecules and Products hereunder and that Partner is able, using reasonable commercial efforts to, assign to Medivation, in each case, to the extent reasonably

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necessary for Medivation to continue researching, Developing, manufacturing, or Commercializing Products, provided, however, that Partner shall be required to assign any such agreement solely to the extent assignment is permitted by such agreement, and Partner is not required to pay any consideration or commence litigation in order to effect an assignment of any such agreement to Medivation. If any such agreement between Partner and a Third Party is not assignable to Medivation (whether by such agreement’s terms or because such agreement does not relate solely to Collaboration Molecules or Products) but is otherwise reasonably necessary for Medivation to continue researching, Developing, manufacturing, or Commercializing Products, then Partner shall reasonably cooperate with Medivation to [*]. If Partner manufactures the Product itself (and thus there is no agreement to assign), then Partner shall supply such bulk Collaboration Molecule or finished Product, as applicable, to Medivation, for a reasonable period (not to exceed [*] after the effective date of termination), pursuant to a supply agreement to be negotiated in good faith by the Parties. Medivation shall reimburse Partner or any of Partner’s Third Party manufacturers for all reasonable out-of-pocket costs incurred pursuant to this Section 13.5(d).

(e) Remaining Inventories. Medivation shall have the right to purchase from Partner any or all of the inventory of Collaboration Molecules and Products held by Partner as of the effective date of termination (that are not committed to be supplied to any Third Party or Sublicensee, in the ordinary course of business, as of the effective date of termination) (i) pursuant to the terms of the supply agreement entered into under Section 13.5(d), or (ii) if the Parties do not enter into a supply agreement, at a price equal to [*]. Medivation shall notify Partner within [*] days after the effective date of termination whether Medivation elects to exercise such right.

13.6 Medivation’s Material Breach. If Partner has the right to terminate this Agreement under Section 13.3(a), then Partner may elect to (a) terminate this Agreement pursuant to Section 13.3(a) or (b) continue this Agreement by notice to Medivation provided, however, that if Partner elects to continue this Agreement then (i) Partner shall retain the licenses granted under Section 7.1 and the license granted to Medivation pursuant to Section 7.2 (other than with respect to Co-Promoting a Co-Promotion Product under Section 7.2(b)) shall terminate; (ii) all payment obligations set forth in Article 8 (including, without limitation, the Parties’ obligation to share Operating Profits and Operating Losses under Section 8.2) and Partner’s diligence obligations under this Agreement (including without limitation Sections 3.3, 5.8(b), and 6.5) shall survive, (iii) all Committees shall be permanently disbanded and subject to Section 2.10, Partner shall have the sole right to decide, without consultation, any matters previously before any such Committee or the Executive Officers, (iv) Medivation shall transfer and assign to Partner all Regulatory Materials for Products in the Shared Territory that are Controlled by Medivation or its Affiliates; (v) Partner shall assume sole responsibility for all Development, Commercialization (other than Co-Promoting Co-Promotion Products pursuant to Sections 5.10 and 5.11), manufacturing, regulatory and all other activities in the Shared Territory, and Medivation’s rights and obligations to Co-Promote all Products in the Shared Territory pursuant to Section 5.10 and 5.11 shall survive, (vi) Medivation rights and Partner’s obligations pursuant to Sections 4.1(b)(i) and 4.1(c)(ii) (in each case with respect to Medivation’s right to

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participate in regulatory activities and meetings) shall terminate and (vi) Medivation shall transfer or transition to Partner, upon Partner’s request, all then-existing Third Party agreements relating solely to Collaboration Molecules and Products that Medivation is able, using reasonable commercial efforts, for Partner to commence or continue researching, Developing, manufacturing or Commercializing Products, provided, however, that Medivation shall be required to assign any such agreement solely to the extent assignment is permitted by such agreement, and Medivation is not required to pay any consideration or commence litigation in order to effect an assignment of any such agreement to Partner. In the event that Partner makes any election as provided in this Section 13.6, the Parties will enter into an appropriate and customary written amendment reflecting such changes. If Partner elects to terminate this Agreement pursuant to Section 13.3(a), the provisions of Section 9.3(c) shall continue to apply in respect of Joint Patents. For the avoidance of doubt, Partner shall be entitled, in its sole discretion, to make the elections provided for in this Section 13.6 upon each occurrence of a material uncured breach by Medivation.

13.7 Other Remedies. Except as provided in Sections 8.6 and 13.2, termination or expiration of this Agreement for any reason shall not release either Party from any liability or obligation that already has accrued prior to such expiration or termination, nor affect the survival of any provision hereof to the extent it is expressly stated to survive such termination. Termination or expiration of this Agreement for any reason shall not constitute a waiver or release of, or otherwise be deemed to prejudice or adversely affect, any rights, remedies or claims, whether for damages or otherwise, that a Party may have hereunder or that may arise out of or in connection with such termination or expiration.

13.8 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by Medivation and Partner are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that each Party, as licensee of certain rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party (such Party, the “Bankrupt Party”) under the U.S. Bankruptcy Code, (a) the other Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any intellectual property licensed to such other Party and all embodiments of such intellectual property, which, if not already in such other Party’s possession, shall be promptly delivered to it (x) upon any such commencement of a bankruptcy proceeding upon such other Party’s written request therefor, unless the Bankrupt Party elects to continue to perform all of its obligations under this Agreement or (y) if not delivered under clause (x), following the rejection of this Agreement by the Bankrupt Party upon written request therefor by the other Party and (b) the Bankrupt Party shall not interfere with the other Party’s rights to intellectual property and all embodiments of intellectual property, and shall assist and not interfere with the other Party in obtaining intellectual property and all embodiments of intellectual property from another entity. The “embodiments” of intellectual property includes all tangible, intangible, electronic or other embodiments of rights and licenses hereunder, including all compounds and products embodying intellectual property, Products, filings with Regulatory Authorities and related rights and Medivation Know-How in the case that Medivation is the Bankrupt Party and Partner Know-How in the case Partner is the Bankrupt Party.

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13.9 Survival. Termination or expiration of this Agreement shall not affect rights or obligations of the Parties under this Agreement that have accrued prior to the date of termination or expiration of this Agreement. Notwithstanding anything to the contrary, the following provisions shall survive and apply after expiration or termination of this Agreement: Sections 7.3, 8.11 (but only for [ * ] years after such expiration or termination), 9.1, 9.3(c) (i.e., in respect to Joint Patents), 10.5, 13.5, 13.7, 13.9, 15.1, 15.3, 15.4, 15.5, 15.6, 15.10, 15.11, 15.12, and 15.13 and Articles 11 (other than Section 11.5), 12 (other than Section 12.4), and 14 (other than Section 14.1, it being understood that, after such expiration or termination, all disputes under this Agreement shall be settled pursuant to Section 14.2 or Section 14.10, as applicable). In addition, the other applicable provisions of Article 8 shall survive to the extent required to make final reimbursements, reconciliations or other payments with respect to Net Sales and costs and expenses incurred or accrued prior to the date of termination or expiration. For any surviving provisions requiring action or decision by a Committee or an Executive Officer, each Party will appoint representatives to act as its Committee members or Executive Officer, as applicable. All provisions not surviving in accordance with the foregoing shall terminate upon expiration or termination of this Agreement and be of no further force and effect.

ARTICLE 14

DISPUTE RESOLUTION

14.1 Disputes. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. In the event of any disputes, controversies or differences that may arise under any theory of law between the Parties out of or in relation to or in connection with this Agreement (other than disputes arising from a Committee), including, without limitation, any alleged failure to perform, or breach, of this Agreement, or any issue relating to the interpretation or application of this Agreement, then upon the request of either Party by written notice, the Parties agree to meet and discuss in good faith a possible resolution thereof, which good faith efforts shall include at least one in-person meeting between the Executive Officers of each Party. If the matter is not resolved within [*] days following the written request for discussions, either Party may then invoke the provisions of Section 14.2. For the avoidance of doubt, any disputes, controversies or differences arising from a Committee pursuant to Article 2 shall be resolved solely in accordance with Section 2.7.

14.2 Arbitration. Any dispute, controversy, difference or claim that may arise under any theory of law between the Parties and not from a Committee, out of or in relation to or in connection with this Agreement (including, without limitation, arising out of or relating to the validity, construction, interpretation, enforceability, breach, performance, application or termination of this Agreement) that is not resolved pursuant to Section 14.1, except for a dispute,

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claim or controversy under Section 14.10, shall be settled by [*] as follows. Either Party, following the end of the [*] period referenced in Section 14.1, may refer such issue to arbitration by submitting a written notice of such request to the other Party. Promptly following receipt of such notice, the Parties shall meet and discuss in good faith and agree on an arbitrator to resolve the issue, which arbitrator shall be neutral and independent of both Parties and all of their respective Affiliates, shall have significant experience and expertise in licensing and partnering agreements in the pharmaceutical and biotechnology industries, and shall have some experience in mediating or arbitrating issues relating to such agreements. If the Parties cannot agree on such arbitrator within [*] days of request by a Party for arbitration, then such arbitrator shall be appointed by the American Arbitration Association, which arbitrator must meet the foregoing criteria. Within [*] days after an arbitrator is selected (or appointed, as the case may be), each Party will deliver to both the arbitrator and the other Party a detailed written proposal setting forth its proposed terms for the resolution for the matter at issue (the “Proposed Terms” of the Party) and a memorandum (the “Support Memorandum”) in support thereof, not exceeding [*] pages in length. The Parties will also provide the arbitrator a copy of this Agreement, as may be amended at such time. Within [*] days after receipt of the other Party’s Proposed Terms and Support Memorandum, each Party may submit to the arbitrator (with a copy to the other Party) a response to the other Party’s Support Memorandum, such response not exceeding [*] pages in length. Neither Party may have any other communications (either written or oral) with the arbitrator other than for the sole purpose of engaging the arbitrator or as expressly permitted in this Section 14.2; provided that, the arbitrator may convene a hearing if the arbitrator so chooses to ask questions of the Parties and hear oral argument and discussion regarding each Party’s Proposed Terms. Within [*] days after the arbitrator’s appointment, the arbitrator will [*]. The decision of the arbitrator shall be final, binding, and unappealable. For clarity, [*].

14.3 Governing Law. This Agreement shall be governed by and construed under the substantive laws of the State of Delaware, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.

14.4 Award. Any award to be paid by one Party to the other Party as determined by the arbitrator as set forth above under Section 14.2 shall be promptly paid in U.S. dollars free of any tax, deduction or offset; and any costs, fees or taxes incident to enforcing the award shall, to the maximum extent permitted by law, be charged against the Party resisting enforcement. Each Party agrees to abide by the award rendered in any arbitration conducted pursuant to this Article 14, and agrees that, subject to the United States Federal Arbitration Act, 9 U.S.C. §§ 1-16, judgment may be entered upon the final award in the Federal District Court in Northern California and that other courts may award full faith and credit to such judgment in order to enforce such award. The award shall include interest from the date of any damages incurred for breach of the Agreement, and from the date of the award until paid in full, at a rate fixed by the arbitrator. With respect to money damages, nothing contained herein shall be construed to permit the arbitrator or any court or any other forum to award consequential, incidental, special, punitive or exemplary damages. By entering into this agreement to arbitrate, the Parties expressly waive any claim for consequential, incidental, special, punitive or exemplary damages. The only damages recoverable under this Agreement are direct compensatory damages.

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14.5 Costs. Each Party shall bear its own legal fees. The arbitrator shall assess his or her costs, fees and expenses against the Party losing the arbitration.

14.6 Injunctive Relief. Nothing in this Article 14 will preclude either Party from seeking equitable relief or interim or provisional relief from a court of competent jurisdiction, including a temporary restraining order, preliminary injunction or other interim equitable relief, concerning a dispute either prior to or during any arbitration if necessary to protect the interests of such Party or to preserve the status quo pending the arbitration proceeding. For the avoidance of doubt, nothing in this Section 14.6 shall otherwise limit a breaching Party’s opportunity to cure a material breach as permitted in accordance with Section 13.3.

14.7 Confidentiality. The arbitration proceeding shall be confidential and the arbitrator shall issue appropriate protective orders to safeguard each Party’s Confidential Information. Except as required by law, no Party shall make (or instruct the arbitrator to make) any public announcement with respect to the proceedings or decision of the arbitrator without prior written consent of the other Party. The existence of any dispute submitted to arbitration, and the award, shall be kept in confidence by the Parties and the arbitrator, except as required in connection with the enforcement of such award or as otherwise required by Applicable Law.

14.8 Survivability. Any duty to arbitrate under this Agreement shall remain in effect and be enforceable after termination of this Agreement for any reason.

14.9 Jurisdiction. For the purposes of this Article 14, the Parties acknowledge their diversity (Partner having its principal place of business in the State of New York and Medivation having its principal place of business in the State of California) and agree to accept the jurisdiction of any U.S. District Court located in California for the purposes of enforcing any awards entered pursuant to this Article 14 and for enforcing the agreements reflected in this Article 14.

14.10 Patent and Trademark Disputes. Notwithstanding Section 14.2, any dispute, controversy or claim relating to the scope, validity, enforceability or infringement of any Collaboration Patents or Marks covering the manufacture, use, importation, offer for sale or sale of Products shall be submitted to a court of competent jurisdiction in the country in which such patent or trademark rights were granted or arose.

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ARTICLE 15

MISCELLANEOUS

15.1 Entire Agreement; Amendment. This Agreement, including the Exhibits hereto, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to the subject matter hereof and supersedes, as of the Effective Date, all prior agreements and understandings between the Parties with respect to the subject matter hereof, including, without limitation, the Existing Confidentiality Agreement. The foregoing shall not be interpreted as a waiver of any remedies available to either Party as a result of any breach, prior to the Effective Date, by the other Party of its obligations pursuant to the Existing Confidentiality Agreement. In the event of any inconsistency between any plan hereunder (including the Joint Development Plan and/or Shared Territory Commercialization Plan) and this Agreement, the terms of this Agreement shall prevail. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth herein and therein. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.

15.2 Force Majeure. Both Parties shall be excused from the performance of their obligations under this Agreement to the extent that such performance is prevented or delayed by force majeure and the nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition. For purposes of this Agreement, force majeure shall mean conditions beyond the control of the Parties, including without limitation, an act of God, war, civil commotion, terrorist act, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe, and failure of plant or machinery (provided that such failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances). Notwithstanding the foregoing, a Party shall not be excused from making payments owed hereunder because of a force majeure affecting such Party.

15.3 Notices. Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement, and shall be addressed to the appropriate Party at the address specified below or such other address as may be specified by such Party in writing in accordance with this Section 15.3, and shall be deemed to have been given for all purposes (a) when received, if hand-delivered or sent by a reputable international expedited delivery service, or (b) five (5) Business Days after mailing, if mailed by first class certified or registered mail, postage prepaid, return receipt requested.

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If to Medivation:		Medivation, Inc.
		201 Spear Street
		3^rd Floor
		San Francisco, CA 94105
		United States
		Attention: Chief Financial Officer

With a copy to:		Cooley Godward Kronish LLP
		Five Palo Alto Square
		3000 El Camino Real
		Palo Alto, CA 94306
		United States
		Attention: Barbara A. Kosacz, Esq.

If to Partner:
With respect to a Development matter:

		Pfizer Inc.
		235 East 42^nd Street
		New York, New York 10017-5755
		U.S.A. Attn: Senior Vice President, Worldwide Clinical Development

With respect to a Commercial matter:

		Pfizer Inc.
		235 East 42^nd Street
		New York, New York 10017-5755
		U.S.A.
		Attn: President, Worldwide Pharmaceuticals Operations

With a copy to:		Pfizer Inc.
		235 East 42^nd Street
		New York, New York 10017-5755
		U.S.A.
		Attn: General Counsel

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15.4 No Strict Construction; Headings. This Agreement has been prepared jointly and shall not be strictly construed against either Party. Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision. The headings of each Article and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section.

15.5 Assignment. Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other, except that a Party may make such an assignment without the other Party’s consent to Affiliates or to a successor to all or substantially all of the business of such Party, whether in a merger, sale of stock, sale of assets or other transaction. Any permitted successor or assignee of rights and/or obligations hereunder shall, in a writing to the other Party, expressly assume performance of such rights and/or obligations (and in any event, any Party assigning this Agreement to an Affiliate shall remain bound by the terms and conditions hereof). In the event that a Party is acquired by a Third Party (such Third Party, hereinafter referred to as an “Acquiror”) or a Third Party is acquired by Partner (such Third Party, hereinafter referred to as a (“Target”), then (x) the intellectual property of such Acquiror held, owned, controlled or developed by such Acquiror (whether prior to or after such acquisition) shall be excluded from Medivation Technology (in the case when the acquired Party is Medivation) and Partner Technology (in the case when the acquired Party is Partner), and (y) the intellectual property of such Target held, owned, controlled or developed by such Target (whether prior to or after such acquisition) shall be excluded from Partner Technology and such Acquiror or Target, as the case may be (and Affiliates of such Acquiror or Target, as the case may be, which are not controlled by (as defined in Article 1) the acquired Party itself or Partner, in the case of a Target) shall not be deemed an “Affiliate” solely for purposes of the applicable components of the foregoing intellectual property definitions, in all such cases if and only if: (a) [*]; (b) [*]; and (c) [*]. For clarity, in the event that a Party is acquired by an Acquiror or Partner acquires a Target and any of the criteria described in subclauses (a) through (c) is not satisfied, then the intellectual property of such Acquiror or Target shall be included within Medivation Technology (in the case when the acquired Party is Medivation) and Partner Technology (in the case when the acquired Party is Partner or Partner has acquired Target), and licensed as provided hereunder, but only to the extent such intellectual property of such Acquiror or Target is legally able to be so licensed pursuant to applicable Third Party licenses, provided however that a Party shall be required to license such intellectual property as long as it is not required to pay any consideration or commence litigation in order to effect such license. Any permitted assignment shall be binding on the successors of the assigning Party. Any assignment or attempted assignment by either Party in violation of the terms of this Section 15.5 (but not the criteria set forth in subclauses (a) through (c)) shall be null, void and of no legal effect.

15.6 Standstill.

(a) Partner agrees that upon the Effective Date and for a period lasting until the earlier of the [*] of the [*] for the [*] in the [*] to have such [*] and [*] after the [*] (the “Standstill Period”), neither Partner nor any of its Affiliates shall, in any manner, directly or indirectly without the prior written consent or invitation of Medivation or its Board of Directors:

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(i) make, effect, initiate, cause or participate in any acquisition of beneficial ownership of any voting securities of Medivation or any voting securities of any subsidiary of Medivation, if the effect of such acquisition would be to entitle Partner to cast directly or indirectly more than [*] of the voting power in any election of directors of Medivation. For purposes of the [*] calculation under this Section 15.6, all such voting securities, rights or options beneficially owned by Partner (including through Affiliates or others) shall be treated on an as-exercised and as-converted basis, but such securities, rights or options beneficially owned by others shall not be so treated;

(ii) make, effect, initiate, cause or participate in any acquisition of any material assets of Medivation or any material assets of any subsidiary of Medivation that would place Medivation or Partner under a legal obligation to make a public disclosure of such activity;

(iii) engage or become a participant in any “solicitation” of (x) “proxies” (as such terms are defined in Regulation 14A under the Exchange Act) or (y) consents to vote any Medivation voting securities;

(iv) form, join or participate in a “group” (as defined in the Exchange Act) for the purpose of taking any action under clauses (i) through (iii) of this Section;

(v) agree or offer to take, or encourage or propose (publicly or otherwise) the taking of any action referred to in subsection (i), (ii), (iii), or (iv) of this Section 15.6(a);

(vi) assist, induce or encourage any other person to take any action of the type referred to in subsection (i), (ii), (iii), (iv), or (v) of this Section 15.6(a);

(vii) enter into any discussions, negotiations, arrangement or agreement with any other person relating to any of the foregoing;

(b) Nothing in this Section 15.6 shall preclude Partner from making proposals on a confidential basis, to Medivation or its Board of Directors, or from seeking a waiver from Medivation of any provision set forth in this Section 15.6, on a confidential basis, and provided such proposal or waiver is not designed to, nor could reasonably be required to, result in public disclosure of such proposal or waiver by either Partner or Medivation. In addition, Medivation agrees that it shall notify Partner within [*] days of its having received a written proposal or term sheet from a Third Party with respect to an Acquisition of Medivation, which proposal Medivation’s Board of Directors has considered and upon such consideration, directed management of Medivation to pursue, it being understood and agreed by Partner that: (i) Medivation shall be under no obligation to specify in such notice the identity of the Third Party, the structure of such transaction, the amount or type of consideration to be paid, or any other aspects of the terms of such proposed transaction; rather only the fact of Medivation’s having received a written proposal or term sheet from a Third Party with respect to an Acquisition of Medivation, which proposal Medivation’s Board of Directors has considered and upon such

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consideration, directed management of Medivation to pursue, (ii) Partner shall have no right to disclose to any Third Party such information contained in such notice, or take any other action which would reasonably likely result in Medivation being required to publicly disclose such information; and (iii) the information disclosed in such notice is the Confidential Information of Medivation, which Partner acknowledges is material, non-public information of Medivation.

(c) The prohibitions set forth in the foregoing Section 15.6(a) (collectively the “Standstill Provisions”) shall not apply to (i) any investment in any securities of Medivation or its subsidiaries by or on behalf of any independently managed pension plan or employee benefit plan or trust, including without limitation (A) any direct or indirect interests in portfolio securities held by an investment company registered under the Investment Company Act of 1940, as amended, or (B) interests in securities comprising part of a mutual fund or broad based, publicly traded market basket or index of stocks approved for such a plan or trust in which such plan or trust invests; or (ii) securities of Medivation or any of its subsidiaries held by a person acquired by Partner (or any of Partner’s Affiliates) on the date such person first entered into an agreement to be acquired by Partner (or such Affiliate) or acquired after such person was acquired by Partner (or such Affiliate) pursuant to an agreement requiring (but only to the extent requiring) such person to acquire such securities, which agreement was in effect on the date such person first entered into an agreement to be acquired by Partner (or such Affiliate), or (iii) any assets or securities of Medivation, as debtor, that are acquired in a transaction subject to the approval of the U.S. Bankruptcy Court pursuant to proceedings under the U.S. Bankruptcy Code.

(d) Upon the occurrence of a Trigger Event (defined below) with respect to Medivation, Partner shall immediately thereafter cease to be bound by the Standstill Provisions. For purposes of this Agreement, (i) a “Trigger Event” shall occur with respect to Medivation if (x) Medivation shall have entered into, or shall have publicly announced its intention to enter into, an agreement or an agreement in principle with a Third Party with respect to an Acquisition (defined below); or (y) any person or group (as defined in Section 13(d)(3) of the Exchange Act) shall have acquired or agreed or caused to be acquired, or commenced or announced an intention to commence a tender offer or an exchange offer to acquire, ownership (including, without limitation, beneficial ownership as defined in Rule 13d-3 under the Exchange Act) of at least [*] of the then outstanding voting securities issued by Medivation or any rights or options to acquire such ownership, including from a Third Party; or (z) any person or group shall have made a bona fide offer or proposal which is made public and which, if effected would result in an Acquisition of Medivation; (ii) “Acquisition“ means, with respect to Medivation (x) a Business Combination, unless, following such Business Combination all or substantially all of the individuals and entities who were the beneficial owners, respectively, of the outstanding voting securities of Medivation immediately prior to such Business Combination beneficially own, directly or indirectly more than [*] of the then-outstanding voting securities entitled to vote generally in the election of directors of the corporation resulting from such Business Combination (including, without limitation, a corporation that as a result of such transaction owns Medivation or all or substantially all of Medivation’s assets either directly or through one or more subsidiaries) in substantially the same proportions as their ownership, immediately prior to such Business Combination, of the outstanding voting securities of Medivation; or (z) the acquisition, directly or indirectly, by any person or group of beneficial ownership of a majority of the then outstanding voting securities of Medivation.

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15.7 Performance by Affiliates. Subject to the limitations of Section 7.4, each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.

15.8 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

15.9 Compliance with Applicable Law. Each Party shall comply with all Applicable Laws in the course of performing its obligations or exercising its rights pursuant to this Agreement.

15.10 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT OR ANY TORT CLAIMS ARISING HEREUNDER, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 15.10 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 11.1, 11.2 OR 11.4, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 12.

15.11 Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable by an arbitrator or by any court of competent jurisdiction from which no appeal can be or is taken, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

15.12 No Waiver. Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time.

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15.13 Independent Contractors. Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to give either Party the power or authority to act for, bind, or commit the other Party in any way. Nothing herein shall be construed to create the relationship of partners, principal and agent, or joint-venture partners between the Parties.

15.14 Third Party Beneficiary. None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party, including without limitation any creditor of either Party hereto. No such Third Party shall obtain any right under any provision of this Agreement or shall by reasons of any such provision make any Claim in respect of any debt, liability or obligation (or otherwise) against either Party hereto.

15.15 Counterparts. This Agreement may be executed in one (1) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

{Signature Page Follows}

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IN WITNESS WHEREOF, the Parties have executed this amended and restated Agreement in duplicate originals by their duly authorized officers as of the October 20, 2008.


MEDIVATION, INC.		PFIZER INC.

By:	/s/ C. P. Machado	By:	/s/ William R. Ringo
Name:	C. Patrick Machado	Name:	William R. Ringo
Title:	SVP & CFO	Title:	SVP Strategy & Business Development

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EXHIBITS

Exhibit A – Partner Exceptions to Competing Product

Exhibit B – Chemical Structure of Dimebon

Exhibit C – [ * ]

Exhibit D – Initial Members of the JSC

Exhibit E – Initial Joint Development Plan and Budget

Exhibit F – Initial Joint Development Plan Outstanding Issues

Exhibit G – Initial Shared Territory Commercialization Plan and Budget

Exhibit H – [ * ] (International Anti-Bribery and Anti-Corruption Procedure

Exhibit I – Compliance Certificate

Exhibit J – List of Medivation Patents

Exhibit K – Joint Press Release

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EXHIBIT A

PARTNER EXCEPTIONS TO COMPETING PRODUCT

[*]

A-1

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EXHIBIT B

CHEMICAL STRUCTURE OF DIMEBON

[*]

B-1

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EXHIBIT C

[*]

C-1

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EXHIBIT D

INITIAL MEMBERS OF THE JSC

[*]

D-1

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EXHIBIT E

INITIAL JOINT DEVELOPMENT PLAN

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EXHIBIT F

INITIAL JOINT DEVELOPMENT PLAN OUTSTANDING ISSUES

{Intentionally left blank}

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EXHIBIT G

INITIAL SHARED TERRITORY COMMERCIALIZATION PLAN AND BUDGET

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EXHIBIT H

[ * ]

INTERNATIONAL ANTI-BRIBERY AND ANTI-CORRUPTION PROCEDURE

{To be provided by Partner on or after the Effective Date}

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EXHIBIT I

COMPLIANCE CERTIFICATE

Pursuant to Section 5.8 of the Agreement, each Party shall certify to the other Party that:

It has been provided with a copy of Pfizer’s International Anti-Bribery and Anti-Corruption Procedure; and

In connection with this Agreement, it has not made any payments or provided any benefit to a Government Official, as defined in Pfizer’s International Anti-Bribery and Anti-Corruption Principles, to induce such Government Official to make any governmental act or decision to help the Parties obtain or retain business and have not made a payment or offered any item or benefit, regardless of values as improper inducement for such Government Official to approve reimburse, prescribe, or purchase a Product, to influence the outcome of a Clinical Trial, or other wise improperly to benefit the Collaboration.

[Company Name]

Name: _______________________

Title: ________________________

Date: ________________________

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EXHIBIT J

LIST OF MEDIVATION PATENTS

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EXHIBIT K

JOINT PRESS RELEASE


For immediate release		Contact:

PFIZER AND MEDIVATION ENTER INTO GLOBAL AGREEMENT TO CO-DEVELOP AND

MARKET DIMEBON FOR THE TREATMENT OF ALZHEIMER’S AND HUNTINGTON’S

DISEASES

— Medivation to Host Conference Call/Webcast Today at 8:30 a.m. Eastern Time —

NEW YORK, NY and SAN FRANCISCO, CA, September 3 – Pfizer Inc (NYSE: PFE) and Medivation, Inc.(NASDAQ: MDVN) announced today that they have entered into an agreement to develop and commercialize Dimebon, Medivation’s investigational drug for treatment of Alzheimer’s disease and Huntington’s disease. Dimebon currently is being evaluated in an international, confirmatory Phase III trial in patients with mild-to-moderate Alzheimer’s disease (www.connectionstudy.com).

Under the terms of the agreement, Medivation will receive an up-front cash payment of $225 million. Medivation also is eligible to receive payments of up to $500 million upon the attainment of development and regulatory milestones plus additional undisclosed commercial milestone payments. Medivation and Pfizer will collaborate on the Phase III program in Alzheimer’s disease, Huntington’s disease development and regulatory filings in the United States. The companies will share all U.S. development and commercialization expenses along with U.S. profits/losses on a 60 percent/40 percent basis, with Pfizer assuming the larger share of both expenses and profit/losses. In addition, Medivation will co-promote Dimebon to specialty physicians in the U.S.

Pfizer will have responsibility for development, regulatory and commercialization outside the U.S. and will pay Medivation royalties on commercial sales outside of the U.S. The agreement is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. J.P. Morgan served as financial advisor, and Cooley Godward Kronish LLP served as legal advisor, to Medivation on this transaction.

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Alzheimer’s disease leads to the death of brain cells and the loss of nerve connections in areas of the brain that govern memory, thinking and behavior. Alzheimer’s disease gradually destroys a person’s memory and ability to learn, reason, make judgments, communicate and carry-out daily activities. No currently marketed Alzheimer’s disease drug appears to stop brain cell death and prevent or restore lost nerve connections.

Dimebon is an orally-available, small molecule that has been shown to inhibit brain cell death in preclinical models relevant to Alzheimer’s disease and Huntington’s disease, making it a potential treatment for these and other neurodegenerative conditions. Based on preclinical data generated to date, Dimebon appears to improve the function of mitochondria, the energy generators in cells that play a vital role in governing brain cell health, growth and overall function. Dimebon also has been shown to stimulate the outgrowth of nerves from brain cells, or neurites, a process that is believed to play an important role in restoring or generating new brain cell connections.

“With more than 18 million people worldwide suffering from the debilitating and ultimately fatal effects of Alzheimer’s disease, Pfizer has made this devastating illness one of our highest priorities,” said Dr. Martin Mackay, president, Pfizer Global Research and Development. “We are working to develop new medicines that improve memory and halt or significantly slow the disease’s progression. We look forward to collaborating with Medivation to bring Dimebon to patients as rapidly as possible.”

“After a rigorous process that garnered substantial interest, we believe that Pfizer is the ideal partner, sharing our vision for Dimebon and capable of maximizing its potential globally,” said Dr. David Hung, president and chief executive officer of Medivation. “As one of the leaders in Alzheimer’s disease, Pfizer is an optimal partner because of its extensive experience developing new medicines; its marketing and commercialization track record; and, its significant global capability to effectively reach primary care physicians, who today prescribe the vast majority of Alzheimer’s disease medications in the U.S.”

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About Dimebon’s Clinical Program

Results from the first pivotal trial of Dimebon in Alzheimer’s disease showed that patients treated with Dimebon experienced statistically significant improvements compared to placebo in key aspects of the disease — memory and thinking, activities of daily living, behavior and overall function. Dimebon’s benefit over placebo continued to increase throughout the 12-month treatment period. At the end of 12 months, Dimebon-treated patients were on average functioning as well or better than they had been at the start of the study on each of 5 clinical endpoints. These results were published in the July 19, 2008 issue of The Lancet, and are noteworthy as untreated Alzheimer’s patients progressively deteriorate over time in these areas.

On July 7, 2008, Medivation announced positive safety and efficacy results from its Phase 2 trial of Dimebon in Huntington’s disease, which was conducted in collaboration with the Huntington Study Group. Dimebon appeared to be well tolerated and showed statistically significant benefit versus placebo in cognition as measured by the Mini-Mental State Examination, a secondary endpoint in the study.

Conference Call Information

Medivation will hold a conference call today at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss this announcement. To participate in the conference call, please dial 8xxx-xxx-xxxx for domestic callers and xxx-xxx-xxxx for international callers. In addition, this call is being Webcast and can be accessed at Medivation’s website at www.medivation.com.

About Pfizer Inc

Founded in 1849, Pfizer is the world’s largest research-based pharmaceutical company. Pfizer is taking new approaches to advancing better health as it discovers, develops, manufactures and delivers quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. Pfizer also partners with healthcare providers, governments and local communities around the world to expand access to medicines and to provide better quality health care and health system support. For more information visit www.pfizer.com

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About Medivation

Medivation, Inc. 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. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. The Company’s current clinical development program includes a pivotal and confirmatory Phase 3 trial of Dimebon in Alzheimer’s disease and a Phase 1-2 clinical trial of MDV3100 in patients with castration-resistant (also known as hormone-refractory) prostate cancer. Medivation recently announced that it plans to continue further development of Dimebon in patients with mild-to-moderate Huntington’s disease based on the positive results seen in its Phase 2 trial. For more information, please visit us at http://www.medivation.com.

Forward Looking Statements

Pfizer Forward Looking Statements: The information contained in this release is as of September 3, 2008. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about an agreement between Pfizer and Medivation to develop and commercialize a product candidate, Dimebon, including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for Dimebon as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2007 and in its reports on Form 10-Q and Form 8-K.

Medivation Forward Looking Statements: This press release contains forward-looking statements, including statements regarding future clinical development plans and milestones, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Medivation’s actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivation’s clinical trials, difficulties or delays in obtaining regulatory approval, enrollment of patients in Medivation’s clinical trials, partnering of Medivation’s product candidates, manufacturing of Medivation’s product candidates, competition with Medivation’s product candidates should they receive marketing approval, the adequacy of Medivation’s financial resources, unanticipated expenditures or liabilities, intellectual property matters, and other risks detailed in Medivation’s filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q filed August 11, 2008 with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

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EX-31.1 3 dex311.htm CERTIFICATION OF PRESIDENT AND CHIEF EXECUTIVE OFFICER Certification of President and Chief Executive Officer

EXHIBIT 31.1

CERTIFICATION PURSUANT TO RULE 13a-14(a) OR RULE 15d-14(a)

I, David T. Hung, M.D., certify that:

1. I have reviewed this quarterly report on Form 10-Q 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 registrant’s 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 registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or 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 registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.


Date: November 10, 2008

/s/ David T. Hung, M.D.
Name:		David T. Hung, M.D.
Title:		President and Chief Executive Officer

EX-31.2 4 dex312.htm CERTIFICATION OF SENIOR VICE PRESIDENT AND CHIEF FINANCIAL OFFICER Certification of Senior Vice President and Chief Financial Officer

EXHIBIT 31.2

CERTIFICATION PURSUANT TO RULE 13a-14(a) OR RULE 15d-14(a)

I, C. Patrick Machado, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Medivation, Inc.;

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.


Date: November 10, 2008

/s/ C. Patrick Machado
Name:		C. Patrick Machado
Title:		Senior Vice President and Chief Financial Officer

EX-32.1 5 dex321.htm CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER Certification of the Chief Executive Officer and Chief Financial Officer

EXHIBIT 32.1

CERTIFICATION OF CHIEF EXECUTIVE AND CHIEF FINANCIAL OFFICERS

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., Chief Executive Officer of Medivation, Inc. (the “Company”), and C. Patrick Machado, Chief Financial Officer of the Company, each hereby certifies that, to the best of his or her knowledge:

(1) The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2008 to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and

(2) The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: November 10, 2008

In Witness Whereof, the undersigned have set his hand hereto as of the 10th day of November, 2008.




/s/ David T. Hung, M.D.		/s/ C. Patrick Machado
Name:	David T. Hung, M.D.	Name:	C. Patrick Machado
Title:	President and Chief Executive Officer	Title:	Senior Vice President and Chief Financial Officer

This certification accompanies the Form 10-Q 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-Q), irrespective of any general incorporation language contained in such filing.

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