Mirati Therapeutics, Inc. (Form: 10-Q, Received: 04/29/2019 16:20:36)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

______________________________________________________

FORM 10-Q

______________________________________________________

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

For the quarterly period ended March 31, 2019

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

Commission File Number: 001-35921

______________________________________________________

MIRATI THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

______________________________________________________



Delaware	46-2693615
(State of Incorporation)	(I.R.S. Employer Identification No.)
9393 Towne Centre Drive, Suite 200
San Diego, California	92121
(Address of Principal Executive Offices)	(Zip Code)

(858) 332-3410

(Registrant’s Telephone Number, Including Area Code)

______________________________________________________

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



Title of Each Class	Trading Symbol	Name of Each Exchange on Which Registered
Common Stock, par value $0.001 per share	MRTX	The Nasdaq Stock Market LLC

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 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 S No o

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes S No o

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 Securities Exchange Act of 1934.



Large accelerated filer	x	Accelerated filer	o
Non-accelerated filer	¨	Smaller reporting company	o
		Emerging growth company	o

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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financing accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

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

Total shares of common stock outstanding as of the close of business on April 22, 2019:



Class		Number of Shares Outstanding
Common Stock, $0.001 par value		36,047,127

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MIRATI THERAPEUTICS, INC.

FORM 10-Q

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PART I. FINANCIAL INFORMATION		4

Item 1.	Condensed Consolidated Financial Statements (Unaudited)	4
	Condensed Consolidated Balance Sheets as of March 31, 2019 and December 31, 2018	4
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three Months Ended March 31, 2019 and 2018	5
	Condensed Consolidated Statements of Changes in Stockholders' Equity for the Three Months Ended March 31, 2019 and 2018	6
	Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2019 and 2018	7
	Notes to Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	23
Item 4.	Controls and Procedures	23

PART II. OTHER INFORMATION		25

Item 1.	Legal Proceedings	25
Item 1A.	Risk Factors	25
Item 2.	Unregistered Sale of Securities and Use of Proceeds	47
Item 3.	Defaults Upon Senior Securities	47
Item 4.	Mine Safety Disclosures	47
Item 5.	Other Information	47
Item 6.	Exhibits	48

SIGNATURES		50

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PART I. FINANCIAL INFORMATION



ITEM 1.	Financial Statements

MIRATI THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except for share and per share amounts)



	March 31, 2019			December 31, 2018
	(Unaudited)
ASSETS
Current assets
Cash and cash equivalents	$	74,605		$	32,694
Short-term investments	226,380			190,096
Other current assets	5,397			3,870
Total current assets	306,382			226,660
Property and equipment, net	429			473
Other long-term assets	2,550			1,321
Total assets	$	309,361		$	228,454
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable and accrued liabilities	$	24,465		$	25,775
Deferred revenue and other current liabilities	638			371
Total current liabilities	25,103			26,146
Deferred revenue and other liabilities	704			732
Total liabilities	25,807			26,878
Commitments and contingencies
Stockholders’ equity
Preferred stock, $0.001 par value, 10,000,000 shares authorized; none issued and outstanding at both March 31, 2019 and December 31, 2018	—			—
Common stock, $0.001 par value; 100,000,000 shares authorized; 36,029,093 and 32,538,857 issued and outstanding at March 31, 2019 and December 31, 2018, respectively	36			33
Additional paid-in capital	873,838			751,109
Accumulated other comprehensive income	9,637			9,479
Accumulated deficit	(599,957		)	(559,045		)
Total stockholders’ equity	283,554			201,576
Total liabilities and stockholders’ equity	$	309,361		$	228,454

See accompanying notes

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MIRATI THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited, in thousands, except for share and per share amounts)



	Three Months Ended March 31,
	2019			2018
Revenue
License and collaboration revenues	$	1,244		$	9,467
Total revenue	1,244			9,467
Operating expenses
Research and development	$	34,240		$	19,659
General and administrative	9,762			5,154
Total operating expenses	44,002			24,813
Loss from operations	(42,758		)	(15,346		)
Other income, net	1,846			637
Net loss	$	(40,912	)	$	(14,709	)
Unrealized gain (loss) on available-for-sale investments	158			(288		)
Comprehensive loss	$	(40,754	)	$	(14,997	)
Basic and diluted net loss per share	$	(1.17	)	$	(0.51	)
Weighted average number of shares used in computing net loss per share, basic and diluted	34,980,361			28,843,578

See accompanying notes

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Mirati Therapeutics, Inc.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

(Unaudited, in thousands, except share data)



Three Months Ended March 31, 2019
	Common Stock			Additional paid-in capital			Accumulated other comprehensive income		Accumulated deficit			Total stockholders' equity

	Shares	Amount
Balance at January 1, 2019	32,538,857	$	33	$	751,109		$	9,479	$	(559,045	)	$	201,576
Net loss for the period	—	—		—			—		(40,912		)	(40,912		)
Issuance of common stock, net of issuance costs	1,854,838	2		107,881			—		—			107,883
Share-based compensation expense	—	—		11,131			—		—			11,131
Exercise of options for cash	235,398	—		2,668			—		—			2,668
Net exercise of warrants	1,400,000	1		(1		)	—		—			—
Unrealized gain on investments	—	—		—			158		—			158
Proceeds from disgorgement of stockholders' short-swing profits	—	—		1,050			—		—			1,050
Balance at March 31, 2019	36,029,093	$	36	$	873,838		$	9,637	$	(599,957	)	$	283,554



Three Months Ended March 31, 2018
	Common Stock			Additional paid-in capital		Accumulated other comprehensive income			Accumulated deficit			Total stockholders' equity

	Shares	Amount
Balance at January 1, 2018	28,622,886	$	29	$	594,407	$	9,479		$	(460,627	)	$	143,288
Net loss for the period	—	—		—		—			(14,709		)	(14,709		)
Share-based compensation expense	—	—		3,660		—			—			3,660
Exercise of options for cash	402,948	—		5,890		—			—			5,890
Unrealized loss on investments	—	—		—		(288		)	—			(288		)
Balance at March 31, 2018	29,025,834	$	29	$	603,957	$	9,191		$	(475,336	)	$	137,841

See accompanying notes

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MIRATI THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, in thousands)



	Three Months Ended March 31,
	2019			2018
Operating activities:
Net loss	$	(40,912	)	$	(14,709	)
Non-cash adjustments reconciling net loss to operating cash flows:
Depreciation of property and equipment	44			41
Accretion of discount on investments	(917		)	(162		)
Share-based compensation expense	11,131			3,660
Changes in operating assets and liabilities:
Other current assets	(1,528		)	502
Other long-term assets	(1,229		)	(25		)
Accounts payable, accrued liabilities, deferred revenue and other liabilities	(1,071		)	2,745
Cash flows used in operating activities	(34,482		)	(7,948		)
Investing activities:
Purchases of short-term investments	(127,458		)	(102,820		)
Sales and maturities of short-term investments	92,250			17,742
Cash flows used in investing activities	(35,208		)	(85,078		)
Financing activities:
Proceeds from issuance of common stock, net of issuance costs	107,883			—
Proceeds from exercise of common stock options	2,668			5,890
Proceeds from disgorgement of stockholders' short-swing profits	1,050			—
Cash flows provided by financing activities	111,601			5,890
Increase (decrease) in cash and cash equivalents	41,911			(87,136		)
Cash and cash equivalents, beginning of period	32,694			107,703
Cash and cash equivalents, end of period	$	74,605		$	20,567

See accompanying notes

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MIRATI THERAPEUTICS, INC.

Notes to Condensed Consolidated Financial Statements

March 31, 2019

(Unaudited)

1. Description of Business

Mirati Therapeutics, Inc. ("Mirati" or the "Company") is a clinical-stage oncology company developing product candidates to address the genetic and immunological promoters of cancer. The Company was incorporated under the laws of the State of Delaware on April 29, 2013 as Mirati Therapeutics, Inc. and is located in San Diego, California. The Company has a wholly owned subsidiary in Canada, MethylGene, Inc., and operates in one business segment, primarily in the United States. The Company's common stock has been listed on the NASDAQ Global Select Market since June 5, 2018, and was previously listed on the NASDAQ Capital Market since July 15, 2013 under the ticker symbol "MRTX."

2. Summary of Significant Accounting Policies

Basis of Presentation

The unaudited condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission ("SEC") and, therefore, certain information and disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") have been omitted.

In the opinion of management, the information reflects all adjustments necessary to make the results of operations for the interim periods a fair statement of such operations. All such adjustments are of a normal recurring nature. Interim results are not necessarily indicative of results for the full year. The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited consolidated financial statements at that date, but does not include all information and footnotes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2018 .

Use of Estimates

The preparation of the Company's unaudited condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period.

Reported amounts and note disclosures reflect the overall economic conditions that are most likely to occur and anticipated measures management intends to take. Actual results could differ materially from those estimates. Estimates and assumptions are reviewed quarterly. Any revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.

Cash, Cash Equivalents and Short-term Investments

Cash and cash equivalents consist of cash and highly liquid securities with original maturities at the date of acquisition of ninety days or less. Investments with an original maturity of more than ninety days are considered short-term investments and have been classified by management as available-for-sale. These investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date, which reflects management’s intention to use the proceeds from sales of these securities to fund its operations, as necessary. Such investments are carried at fair value, and the unrealized gains and losses are reported as a component of accumulated other comprehensive income in stockholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis.

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Concentration of Credit Risk

The Company invests its excess cash in accordance with its investment policy. The Company's investments are comprised primarily of commercial paper and debt instruments of financial institutions, corporations, U.S. government-sponsored agencies and the U.S. Treasury. The Company mitigates credit risk by maintaining a diversified portfolio and limiting the amount of investment exposure as to institution, maturity and investment type. Financial instruments that potentially subject the Company to significant credit risk consist principally of cash equivalents and short-term investments.

Revenue Recognition

The Company recognizes revenue in connection with a collaboration and license agreement in accordance with the guidance of Revenue From Contracts With Customers, Accounting Standards Codification ("ASC") Topic 606 ("Topic 606). Under Topic 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements the Company determines are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. See Note 9 for a complete discussion of the revenue recognition for the Company’s collaboration and license agreement.

Net loss per share

Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration for common share equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and common share equivalents outstanding for the period. Common share equivalents outstanding, determined using the treasury stock method, are comprised of shares that may be issued under the Company’s stock option and warrant agreements.

The following table presents the weighted-average number of common share equivalents, calculated using the treasury stock method, not included in the calculation of diluted net loss per share due to the anti-dilutive effect of the securities:



	Three Months Ended March 31,
	2019	2018
Common stock options	2,316,993	1,458,774
Common stock warrants	11,005,602	11,395,851
Total	13,322,595	12,854,625

3. Recently Adopted and Recently Issued Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board ("FASB") or other standard setting bodies that are adopted by the Company as of the specified effective date.

Recently Adopted Accounting Pronouncements

In February 2016, the FASB issued Accounting Standards Update ("ASU") 2016-02, Leases (Topic 842) in order to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet for those leases classified as operating leases under previous GAAP. ASU 2016-02 requires a lessee to recognize a liability for lease payments (the lease liability) and a right-of-use asset (representing its right to use the underlying asset for the lease term) on the balance sheet. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018 (including interim periods within those periods) using a modified retrospective approach.

In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842): Targeted Improvements , which provides entities an optional transition method to apply the new guidance as of the adoption date, rather than as of the earliest period presented. In

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transition, entities may also elect a package of practical expedients that must be applied in its entirety to all leases commencing before the effective date, unless the lease was modified, to not reassess (a) the existence of a lease, (b) lease classification or (c) determination of initial direct costs, which effectively allows entities to carryforward accounting conclusions under previous U.S. GAAP.

The Company adopted ASU 2016-02, using the optional transition method and electing the package of practical expedients described above on January 1, 2019. Due to the adoption, the Company recognized a new lease liability on the Company's consolidated balance sheet for its operating lease of office and lab space of $367,000 on January 1, 2019, with a corresponding right-of-use asset of the same amount based on the present value of the remaining minimum rental payments. See Note 11 for further discussion.

In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Non-controlling Interests with a Scope Exception . This ASU allows companies to exclude a down round feature when determining whether a financial instrument (or embedded conversion feature) is considered indexed to the entity’s own stock. As a result, financial instruments (or embedded conversion features) with down round features may no longer be required to be classified as liabilities. A company will recognize the value of a down round feature only when it is triggered and the strike price has been adjusted downward. For equity-classified freestanding financial instruments, such as warrants, an entity will treat the value of the effect of the down round, when triggered, as a dividend and a reduction of income available to common shareholders in computing basic earnings per share. For convertible instruments with embedded conversion features containing down round provisions, entities will recognize the value of the down round as a beneficial conversion discount to be amortized to earnings. Effective January 1, 2019, the Company adopted the provisions of ASU 2017-11. The adoption did not have a material impact on the Company's consolidated financial statements or related financial statement disclosures.

On August 17, 2018, the SEC adopted amendments to certain disclosure requirements in Securities Act Release No. 33-10532, Disclosure Update and Simplification. Among the amendments is the requirement to present the changes in stockholders’ equity in the interim financial statements (either in a separate statement or footnote) in quarterly reports on Form 10-Q. The amendments are effective for all filings made on or after November 5, 2018. In light of the timing of effectiveness of the amendments and proximity of effectiveness to the filing date for most filers’ quarterly reports, the SEC indicated it would not object if the filer’s first presentation of the changes in stockholders’ equity is included in its Form 10-Q for the quarter that begins after the effective date of the amendments. The Company has included a condensed consolidated statement of changes in stockholders' equity for the three months ended March 31, 2019 and 2018 in the Company's consolidated financial statements included herein.

In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 . The amendments provide guidance on whether certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606. It also specifically (i) addresses when the participant should be considered a customer in the content of a unit of account, (ii) adds unit-of-account guidance in ASC 808 to align with guidance with ASC 606, and (iii) precludes presenting revenue from a collaborative arrangement together with revenue recognized under ASC 606 if the collaborative arrangement participant is not a customer. The guidance in ASU 2018-18 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted and should be applied retrospectively. The Company elected to early adopt this guidance effective January 1, 2019. The adoption had no impact on the Company's consolidated financial statements.

Recently Issued Accounting Pronouncements

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement . The new guidance modifies the disclosure requirements on fair value measurements in Topic 820. The amendments in ASU 2018-13 are effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company does not anticipate that the adoption of ASU 2018-13 will have a material impact on the Company's consolidated financial statements or related financial statement disclosures.

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4. Short-term Investments

The following tables summarize the Company's short-term investments (dollars in thousands):



		As of March 31, 2019
	Maturity	Amortized cost		Gross unrealized gains		Gross unrealized losses			Estimated fair value
Corporate debt securities	1 year or less	$	91,173	$	75	$	(4	)	$	91,244
Commercial paper	1 year or less	114,219		44		(1		)	114,262
U.S. Treasury bills	1 year or less	18,881		5		—			18,886
Other sovereign securities	1 year or less	1,988		—		—			1,988
		$	226,261	$	124	$	(5	)	$	226,380



		As of December 31, 2018
	Maturity	Amortized cost		Gross unrealized gains		Gross unrealized losses			Estimated fair value
Corporate debt securities	1 year or less	$	111,933	$	26	$	(43	)	$	111,916
Commercial paper	1 year or less	74,433		—		(24		)	74,409
U.S. Treasury bills	1 year or less	3,771		—		—			3,771
		$	190,137	$	26	$	(67	)	$	190,096

The Company has classified all of its investment securities as available-for-sale as the sale of such securities may be required prior to maturity to implement management strategies, and accordingly, carries these investments at fair value. Unrealized gains and losses on available-for-sale securities are included as a component of comprehensive loss. At March 31, 2019 , the Company did not have any securities in material unrealized loss positions. The Company reviews its investments to identify and evaluate investments that have an indication of possible other-than-temporary impairment. Factors considered in determining whether a loss is other-than-temporary include the length of time and extent to which fair value has been less than the cost basis, the financial condition and near-term prospects of the investee, and the Company’s intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value. The Company does not intend to sell any investments prior to recovery of their amortized cost basis for any investments in an unrealized loss position.

5. Fair value measurements

The Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1 or 2 within the fair value hierarchy as described in the accounting standards for fair value measurements.

The authoritative guidance for fair value measurements defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or the most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Market participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The guidance prioritizes the inputs used in measuring fair value into the following hierarchy:


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


•	Level 2- Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable; and


•	Level 3- Unobservable inputs in which little or no market activity exists, therefore requiring an entity to develop its own assumptions about the assumptions that market participants would use in pricing.

The following tables summarize the assets measured at fair value on a recurring basis (in thousands):

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	March 31, 2019
	Total		Level 1		Level 2		Level 3
Assets
Cash and cash equivalents:
Cash	$	1,909	$	1,909	$	—	$	—
Money market funds	72,696		72,696		—		—
Total cash and cash equivalents	74,605		74,605		—		—

Short-term investments:
U.S. Treasury bills	18,886		18,886		—		—
Corporate debt securities	91,244		—		91,244		—
Commercial paper	114,262		—		114,262		—
Other sovereign securities	1,988		—		1,988		—
Total short-term investments	226,380		18,886		207,494		—

Total	$	300,985	$	93,491	$	207,494	$	—



	December 31, 2018
	Total		Level 1		Level 2		Level 3
Assets
Cash and cash equivalents:
Cash	$	3,731	$	3,731	$	—	$	—
Money market funds	28,963		28,963		—		—
Total cash and cash equivalents	32,694		32,694		—		—

Short-term investments:
U.S. Treasury bills	3,771		3,771		—		—
Corporate debt securities	111,916		—		111,916		—
Commercial paper	74,409		—		74,409		—
Total short-term investments	190,096		3,771		186,325		—
Total	$	222,790	$	36,465	$	186,325	$	—

The Company’s investments in Level 1 assets are valued based on publicly available quoted market prices for identical securities as of March 31, 2019 and December 31, 2018 . The Company determines the fair value of Level 2 related securities with the aid of valuations provided by third parties using proprietary valuation models and analytical tools. These valuation models and analytical tools use market pricing or prices for similar instruments that are both objective and publicly available, including matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids and/or offers. There were no transfers between fair value measurement levels during the three months ended March 31, 2019 or the year ended December 31, 2018 .

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6. Other current assets and other long-term assets

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



	March 31,		December 31,
	2019		2018
Prepaid expenses	$	1,333	$	1,261
Deposits and other receivables	2,985		1,841
Interest receivables	792		768
Right-of-use asset	287		—
	$	5,397	$	3,870

The other long-term assets balance consisted of $2.6 million and $1.3 million in deposits paid in conjunction with the Company's research and development activities as of March 31, 2019 and December 31, 2018 , respectively.

7. Property and equipment, net

Property and equipment consisted of the following (in thousands):



	March 31,			December 31,
	2019			2018

Computer equipment	$	201		$	201
Office and other equipment	260			260
Laboratory equipment	729			729
Leasehold improvements	63			63
Gross property and equipment	1,253			1,253
Less: Accumulated depreciation	(824		)	(780		)
Property and equipment, net	$	429		$	473

The Company incurred immaterial depreciation expense for both the three months ended March 31, 2019 and 2018 .

8. Accounts payable, accrued liabilities and long-term liabilities

Accounts payable and accrued liabilities consisted of the following (in thousands):



	March 31,		December 31,
	2019		2018

Accounts payable	$	10,067	$	8,531
Accrued clinical expense	10,506		10,154
Accrued development and other expense	1,454		1,243
Accrued compensation and benefits	2,438		5,847
	$	24,465	$	25,775

The long-term liabilities balance of $0.7 million as of March 31, 2019 consisted primarily of other liabilities. As of December 31, 2018 the long-term liabilities balance of $0.7 million consisted of $0.1 million in deferred revenue and $0.6 million in other liabilities.

9. BeiGene Agreement

Terms of Agreement

On January 7, 2018, the Company and BeiGene Ltd, ("BeiGene") entered into a Collaboration and License Agreement (the “Agreement”), pursuant to which the Company and BeiGene agreed to collaboratively develop sitravatinib in Asia (excluding

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Japan and certain other countries), Australia and New Zealand (the “Licensed Territory”). Under the Agreement, the Company granted BeiGene an exclusive license to develop, manufacture and commercialize sitravatinib in the Licensed Territory, with Mirati retaining exclusive rights for the development, manufacture and commercialization of sitravatinib outside the Licensed Territory.

As consideration for the rights granted to BeiGene under the Agreement, BeiGene paid the Company a non-refundable, non-creditable up-front fee of $10.0 million . BeiGene is also required to make milestone payments to the Company of up to an aggregate of $123.0 million upon the first achievement of specified clinical, regulatory and sales milestones. The Agreement additionally provides that BeiGene is obligated to pay to the Company royalties at tiered percentage rates ranging from mid-single digits to twenty percent on annual net sales of licensed products in the Licensed Territory, subject to reduction under specified circumstances. The Agreement also provides that the Company will supply BeiGene with sitravatinib for use in BeiGene’s development activities in the Licensed Territory.

The Agreement will terminate upon the expiration of the last royalty term for the licensed products, which is the latest of (i) the date of expiration of the last valid patent claim related to the licensed products under the Agreement, (ii) 10 years after the first commercial sale of a licensed product and (iii) the expiration of any regulatory exclusivity as to a licensed product. BeiGene may terminate the Agreement at any time by providing 60 days prior written notice to the Company. Either party may terminate the Agreement upon a material breach by the other party that remains uncured following 60 days after the date of written notice of such breach or upon certain bankruptcy events. In addition, the Company may terminate the Agreement upon written notice to BeiGene under specified circumstances if BeiGene challenges the licensed patent rights.

Revenue Recognition

The Company evaluated the Agreement under Topic 606. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under the Agreement, the Company performed the following steps: (i) identified the promised goods or services in the contract; (ii) determined whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measured the transaction price, including any constraints on variable consideration; (iv) allocated the transaction price to the performance obligations; and (v) recognized revenue when (or as) the Company satisfied each performance obligation.

The Company determined the transaction price is equal to the up-front fee of $10.0 million . The transaction price was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In estimating the stand-alone selling price for each performance obligation, the Company developed assumptions that require judgment and included forecasted revenues, expected development timelines, discount rates, probabilities of technical and regulatory success and costs for manufacturing clinical supplies. A description of the performance obligations identified under the Agreement, as well as the amount of revenue allocated to each performance obligation, follows:

Licenses of Intellectual Property. The license to the Company’s intellectual property, bundled with the associated know-how, represents a distinct performance obligation. The transfer of the license and associated know-how to BeiGene was completed during the three months ended March 31, 2018. The Company recognized no revenue associated with the license and know-how during the three months ended March 31, 2019 and recognized $9.5 million during the three months ended March 31, 2018 as license and collaboration revenues in its condensed consolidated statements of operations and comprehensive loss.

Manufacturing Supply Services. The Company's initial obligation to supply sitravatinib for clinical development in the Licensed Territory represents a distinct performance obligation. As such, the Company deferred $0.5 million of the transaction price related to the manufacturing supply services. The Company recognizes revenue when BeiGene obtains control of the goods, upon delivery, over the period of the obligation, which began in late 2018 and will continue into 2020. The Company recognized $1.2 million as license and collaboration revenues for this performance obligation for the three months ended March 31, 2019 , of which $1.1 million relates to cost-sharing payments due from BeiGene and $0.1 million relates to recognition from the deferred revenue balance. No revenue related to the manufacturing supply services obligation was recognized during the three months ended March 31, 2018 . At March 31, 2019 , $1.1 million of cost-sharing receivable from BeiGene was recorded in other current assets on the condensed consolidated balance sheets.

Milestone Payments. The Company is entitled to development milestones under the agreement. The next clinical development milestone is for BeiGene initiating the first pivotal clinical trial in the Licensed Territory upon which the Company will be paid a $5.0 million milestone payment. The Company is also entitled to certain regulatory milestone payments which are paid upon receipt of regulatory approvals within the Licensed Territory. No milestone payments were earned during the three months ended March 31, 2019 or 2018 . The Company

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evaluated whether the remaining milestones are considered probable of being reached and determined that the remaining potential milestone payments are probable of significant revenue reversal as their achievement is highly dependent on factors outside the Company's control. Therefore, these payments have been fully constrained and are not included in the transaction price. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint, and if necessary, adjust its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect the reported amount of license and collaboration revenues in the period of adjustment.

Royalties. As the license is deemed to be the predominant item to which sales-based royalties relate, the Company will recognize revenue when the related sales occur. No royalty revenue was recognized during the three months ended March 31, 2019 or 2018 .

The following table presents a summary of the activity in the Company's contract liabilities during the three months ended March 31, 2019 (in thousands):



Opening balance, January 1, 2019	$	(481	)
Revenue from performance obligations satisfied during reporting period	108
Closing Balance, March 31, 2019	$	(373	)

The closing balance represents deferred revenue and is classified primarily within current liabilities at March 31, 2019 .

10. Warrants

As of March 31, 2019 , the following warrants for common stock were issued and outstanding:



Issue date	Expiration date	Exercise price		Number of warrants outstanding
January 11, 2017	None	$	0.001	5,858,238
November 20, 2017	None	$	0.001	4,137,999
June 11, 2018	None	$	0.001	421,650
				10,417,887

During the three months ended March 31, 2019 , 1,400,025 warrants for shares of the Company's common stock were exercised via cashless exercise, resulting in the issuance of 1,400,000 shares of common stock. During the three months ended March 31, 2018 , no warrants were exercised.

11. Commitments and Contingencies

On June 24, 2014, the Company entered into a lease agreement for completed office and laboratory space located in San Diego, California. The office space under the lease is the Company's corporate headquarters. The lease commenced in two phases (in July 2014 and March 2015) at a combined total initial monthly rent of $24,100 per month. The leased property is subject to a 3% annual rent increase following availability. In addition to such base monthly rent, the Company is obligated to pay certain customary amounts for its share of operating expenses and facility amenities. The original lease provided for expiration on January 31, 2018. On March 23, 2017, the Company entered into a First Amendment to Lease Agreement to amend the original lease agreement and to extend the term of the original lease for one year through January 31, 2019. On April 5, 2018, the Company entered into a Second Amendment to Lease Agreement to extend the lease term through January 31, 2020. Subsequently, on August 2, 2018, the Company entered into a Third Amendment to Lease Agreement to expand the size of the existing space for an additional base rent of $4,000 per month. All other terms and covenants from the original lease agreement remain unchanged.

The Company's building lease is considered to be an operating lease. The lease agreement indicates the interest rate applicable to the lease is 12% , therefore the Company used a discount rate of 12% to calculate the value of its lease obligations. As of March 31, 2019 , the condensed consolidated balance sheet includes a $0.3 million operating lease right-of-use asset within other current assets, and a $0.3 million operating lease liability in deferred revenue and other current liabilities. For the three months ended March 31, 2019 , the Company recorded $0.1 million in operating lease cost and the building lease has a remaining lease term of approximately one year from March 31, 2019 . As of March 31, 2019 , remaining lease payments on an undiscounted basis are $0.3 million for 2019 and an immaterial amount for 2020.

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12. Stockholders' Equity

Sale of Common Stock

In January 2019, the Company sold 1,854,838 shares of its common stock at a public offering price of $62.00 per share. After deducting underwriter discounts, commissions and offering expenses, the Company received net cash proceeds from the transaction of $107.9 million .

Share-based Compensation

Total share-based compensation expense by statement of operations classification is presented below (in thousands):



	Three Months Ended March 31,
	2019		2018
Research and development expense	$	5,157	$	1,493
General and administrative expense	5,974		2,167
	$	11,131	$	3,660

During the three months ended March 31, 2019 , 235,398 shares were issued pursuant to stock option exercises, generating net proceeds of $2.7 million . During the three months ended March 31, 2018 , 402,948 shares were issued pursuant to stock option exercises, generating net proceeds of $5.9 million .

Disgorgement Proceeds

In January 2019, the Company received a payment of $1.1 million representing a disgorgement of short-swing profits from the sale of common stock by a beneficial owner pursuant to Section 16(b) of the Securities Exchange Act of 1934, as amended. The Company recognized these proceeds as a capital contribution from stockholders and reflected a corresponding increase to additional paid-in capital.

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

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited financial statements and related notes included in this Quarterly Report on Form 1O-Q and the audited financial statements and notes thereto as of and for the year ended December 31, 2018 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K filed by us with the Securities and Exchange Commission ("SEC") .

This Quarterly Report on Form 10-Q may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Such forward-looking statements, which represent our intent, belief, or current expectations, involve risks and uncertainties. We use words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “predict,” “potential,” “believe,” “should” and similar expressions to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements may include, but are not limited to, statements concerning projections about our accounting and finances, plans and objectives for the future, future operating and economic performance and other statements regarding future performance. Although we believe the expectations reflected in these forward-looking statements are reasonable, such statements are inherently subject to risk and we can give no assurances that our expectations will prove to be correct. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this Quarterly Report on Form 10-Q. As a result of many factors, including without limitation those set forth under “Risk Factors” under Item 1A of Part II below, and elsewhere in this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements. We undertake no obligation to update these forward-looking statements to reflect events or circumstances after the date of this report or to reflect actual outcomes.

References in the following discussion to "we," "our," "us," "Mirati" or "the Company" refer to Mirati Therapeutics, Inc. and its subsidiaries.

Overview

Company Overview

Mirati Therapeutics, Inc. is a clinical-stage oncology company developing product candidates to address the genetic and immunological promoters of cancer. Our precision oncology clinical programs utilize genomic testing to identify and select cancer patients who we believe would be most likely to benefit from targeted treatment. In immuno-oncology, we are advancing a clinical program where our product candidate has the potential to improve the immune environment of tumor cells and enhance and expand the efficacy of existing cancer immunotherapy medicines when given in combination. Our KRAS inhibitor program is focused on developing novel inhibitors of KRAS mutations and includes one clinical program and a preclinical program. We also have additional preclinical programs which include potentially first-in-class and best-in-class product candidates specifically designed to address mutations and tumors where few treatment options exist. We approach each of our discovery and development programs with a singular focus: to translate our deep understanding of the molecular drivers of cancer into better therapies and better outcomes for patients.

Our clinical programs consist of two product candidates: sitravatinib, a multi-kinase inhibitor, and MRTX849, a KRAS G12C inhibitor. We have several early discovery programs, including a preclinical program for a KRAS G12D inhibitor.

Sitravatinib

Sitravatinib is a spectrum-selective kinase inhibitor designed to potently inhibit receptor tyrosine kinases (“RTK”s), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. Sitravatinib is an investigational agent that is being evaluated both in combination with an immune checkpoint inhibitor and as a single agent.

Sitravatinib in Combination with Immune Checkpoint Inhibitors

Background

Sitravatinib's potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.

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As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab ( OPDIVO ®), Bristol-Myers Squibb Company’s (“BMS”) anti-PD-1 checkpoint inhibitor, in patients with non-small cell lung cancer ("NSCLC") who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib is also being developed in certain Asian territories in collaboration with BeiGene, Ltd. ("BeiGene") who are evaluating sitravatinib in combination with tislelizumab, BeiGene's investigational anti-PD-1 checkpoint inhibitor in a number of advanced solid tumors.

Program Update

In an ongoing Phase 2 clinical trial, we are evaluating sitravatinib in combination with nivolumab in patients with NSCLC who have experienced documented disease progression following prior treatment with a checkpoint inhibitor. On October 22, 2018, we reported data from this clinical trial at the 2018 European Society of Medical Oncology Congress ("ESMO"), based on a data cutoff date of August 27, 2018. A summary of these data, with response confirmations updated after the data cutoff date, is presented below:


•	56 patients were evaluable for response with at least one radiographic scan. Patients had a median of two lines of previous therapy;


•	45 of 56 evaluable patients demonstrated tumor reductions; 18 of whom demonstrated tumor reductions greater than 30%;


•	11 of 56 evaluable patients achieved a confirmed Partial Response ("PR") or Complete Response;


•	26 of 56 evaluable patients remained on treatment at the time of data cut-off including eight responding patients;


•	A preliminary Kaplan-Meier estimate of median duration of response was greater than nine months, with six responding patients treated for more than six months and two responding patients treated for more than 12 months; and


•	The combination has shown an acceptable toxicity profile, and most adverse events reported by investigators were Grade 1 or 2.

We held an end of Phase 2 meeting with the U.S. Food and Drug Administration ("FDA") in the third quarter of 2018 with respect to the development of sitravatinib in combination with a checkpoint inhibitor in NSCLC. Based on feedback received from the FDA, early in the second quarter of 2019 we expect to initiate a Phase 3 randomized clinical trial in second-line NSCLC patients. The Phase 3 clinical trial is comparing the combination of sitravatinib plus nivolumab to docetaxel in patients whose tumors have progressed on prior therapy with platinum-chemotherapy in combination with a checkpoint inhibitor. Ultimately, we expect the results of this clinical trial to enable a new drug application (“NDA”) submission for the treatment of NSCLC patients whose tumors have progressed following treatment with a platinum-containing regimen in combination with a checkpoint inhibitor. This Phase 3 clinical trial will include an interim analysis of objective response rates (which we expect to complete by the end of 2020) as a surrogate endpoint to serve as the basis for a potential NDA submission seeking accelerated approval in the United States. The primary endpoint of the final analysis for the Phase 3 clinical trial (which we expect to complete by the end of 2021) will be overall survival.

On January 7, 2019, we announced a clinical collaboration with BMS in connection with the aforementioned Phase 3 clinical trial. Under the terms of the collaboration, Mirati will sponsor and fund the clinical trial and BMS will provide nivolumab at no cost. In certain specified cases, BMS will have an exclusive right to negotiate a commercial agreement with us for a limited period of time with respect to developing and commercializing sitravatinib worldwide excluding certain territories in Asia, Australia and New Zealand. We maintain global development and commercial rights to sitravatinib outside of certain Asian territories, where we have partnered with BeiGene, and we are free to develop the program in combination with other agents.

During the third quarter of 2018, we initiated an open label Phase 2 clinical trial of sitravatinib in combination with nivolumab in patients with advanced or metastatic urothelial carcinoma who previously failed treatment with an immune checkpoint inhibitor. We expect to receive initial data from this clinical trial in the second half of 2019.

During the third quarter of 2018, we also initiated an open label Phase 2 window of opportunity clinical trial to assess the mechanism of action of sitravatinib combined with nivolumab in patients with advanced clear cell renal cell cancer ("RCC"). We expect to receive initial data from this clinical trial in the second half of 2019.

Sitravatinib as a Single Agent

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Background

Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial in patients with NSCLC and other tumor types who have genetic alterations in Casitas B-lineage Lymphoma ("CBL").

Program update

On October 21, 2018, we reported data from this Phase 1b clinical trial in a presentation at ESMO. The presentation provided an update from the pre-planned expansion cohort of the Phase 1b clinical trial of single agent sitravatinib in patients with CBL inactivating mutations. CBL mutations are present in approximately 1.5% of NSCLC tumors, 3.5% of melanoma tumors, and 2% of cancers of unknown origin. As of the data cut-off on September 4, 2018, eight patients were evaluable:


•	In the subset of evaluable NSCLC patients (n=2), one confirmed PR was observed, and one patient experienced stable disease with significant tumor regression;


•	In the subset of evaluable melanoma patients (n=2), one confirmed PR was observed, and one patient had stable disease; and


•	In the subset of evaluable patients with other solid tumors (n=4), two had stable disease and two had progression of disease.

Enrollment continues in this Phase 1b expansion clinical trial with an emphasis on patients with CBL inactivating mutations in NSCLC and melanoma. We expect to provide a clinical update in the second half of 2019 and to define a potential registration pathway based on updated data at that time.

Sitravatinib Development in Collaboration with BeiGene, Ltd.

In January 2018, we entered into a Collaboration and License Agreement (the “BeiGene Agreement”) with BeiGene, pursuant to which we and BeiGene agreed to collaboratively develop sitravatinib in Asia (excluding Japan and certain other countries), Australia and New Zealand (the “Licensed Territory”). Under the BeiGene Agreement, we granted BeiGene an exclusive license to develop, manufacture and commercialize sitravatinib in the Licensed Territory, and we retained exclusive rights for the development, manufacturing and commercialization of sitravatinib outside the Licensed Territory.

In November 2018, we announced the dosing of the first patient under the BeiGene Agreement in a Phase 1b clinical trial to assess the safety and tolerability, pharmacokinetics and preliminary anti-tumor activity of sitravatinib in combination with BeiGene's investigational anti-PD-1 antibody, tislelizumab, in patients with advanced solid tumors. The clinical trial is currently enrolling patients in China and Australia. BeiGene's clinical trials will evaluate the combination of sitravatinib and tislelizumab in patients with NSCLC, RCC, hepatocellular cancer, gastric cancer and ovarian cancer. We expect to receive initial proof of concept data from these clinical trials in the second half of 2019 and the first half of 2020.

KRAS Inhibitor Program

Background

The RAS family of genes is the most commonly mutated oncogene and mutations in this gene family occur in up to approximately 25% of all human cancers. Among the RAS family members, mutations most frequently occur in KRAS (approximately 85% of all RAS family mutations). Tumors characterized by KRAS mutations are commonly associated with poor prognosis and resistance to therapy. Nonclinical studies have demonstrated that cancer cells exhibiting KRAS mutations are highly dependent on KRAS function for cell growth and survival. Historically, KRAS has been extremely difficult to directly inhibit due to the absence of a tractable small molecule drug binding site. Our KRAS inhibitor program is focused on the discovery and development of small molecule compounds that target KRAS G12C and G12D. We intend to pursue development of our KRAS G12C inhibitor program in both single agent and rational combination approaches to maximize the potential market opportunity.

Program Update

Our lead KRAS G12C compound, MRTX849, is an investigational, specific, potent and orally available small molecule. MRTX849 is designed to directly inhibit KRAS G12C mutations which are present in approximately 14% of NSCLC adenocarcinoma patients, 4% of colorectal cancer (“CRC”) patients, 2% of pancreatic cancer patients, as well as smaller percentages of several other difficult-to-treat cancers. Single agent treatment with MRTX849 has shown complete regression in a subset of

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KRAS G12C-positive human tumor models implanted in mice. We received FDA authorization of our Investigational New Drug Application for MRTX849 in November 2018, and on January 15, 2019, we announced that we had dosed the first patient in the dose escalation phase of a phase 1/2 clinical trial in patients with advanced solid tumors that harbor G12C mutations. This trial is designed to enable rapid expansion of the single agent cohorts and could potentially serve as the basis of an NDA filing for accelerated approval by the FDA. This trial also enables exploratory combination cohorts. Following single agent dose escalation, we plan to expand into cohorts that include patients with NSCLC, CRC and those with other tumors that carry the G12C mutation. We expect to report early clinical results in the second half of 2019. We also have a preclinical program targeting KRAS G12D mutations and expect to identify a clinical candidate by the fourth quarter of 2019.

Critical Accounting Policies and Significant Judgments and Estimates

Our discussion and analysis of financial condition and results of operations are based upon our condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make significant estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses and related disclosures. On an ongoing basis, our actual results may differ significantly from our estimates.

There have been no material changes to our critical accounting policies and estimates from the information provided in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, included in our Annual Report on Form 10-K for the year ended December 31, 2018 .

Results of Operations

Comparison of the Three Months Ended March 31, 2019 and 2018

The following table summarizes the significant items within our results of operations for the three months ended March 31, 2019 and 2018 (in thousands):



	Three months ended March 31,				Increase
	2019		2018		(Decrease)
License and collaboration revenues	$	1,244	$	9,467	$	(8,223	)

Research and development expenses	$	34,240	$	19,659	$	14,581
General and administrative expenses	9,762		5,154		4,608
Other income, net	1,846		637		1,209

Revenues

License and collaboration revenues relate to the BeiGene Agreement under which BeiGene was granted an exclusive license to develop, manufacture and commercialize sitravatinib in the Licensed Territory. License and collaboration revenues for the three months ended March 31, 2019 were $1.2 million and relate to revenues earned related to a manufacturing supply services agreement with BeiGene. License and collaboration revenues for the three months ended March 31, 2018 were $9.5 million and relate to the transfer of the license and associated know-how to BeiGene.

Research and development expenses

Research and development expenses consist primarily of:


•	salaries and related expenses for personnel, including expenses related to stock options or other share-based compensation granted to personnel in research and development functions;


•	fees paid to external service providers such as Clinical Research Organizations ("CROs") and contract manufacturing organizations related to clinical trials, including contractual obligations for clinical development, clinical sites, manufacturing and scale-up, and formulation of clinical drug supplies;


•	fees paid to contract services related to drug discovery efforts including chemistry and biology services; and

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•	costs for allocated facilities and depreciation of equipment.

We record research and development expenses as incurred. We account for nonrefundable advance payments for goods and services that will be used in future research and development activities as expense when the services have been performed or when the goods have been received. At this time, due to the risks inherent in the clinical development process and the early stage of our product development programs and preclinical programs, we are unable to estimate with any certainty the costs we will incur in the continued development of sitravatinib, MRTX849, and our preclinical programs. The process of conducting clinical trials necessary to obtain regulatory approval and manufacturing scale-up to support expanded development and potential future commercialization is costly and time consuming. Any failure by us or delay in completing clinical trials, manufacturing scale-up or in obtaining regulatory approvals could lead to increased research and development expense and, in turn, have a material adverse effect on our results of operations. We expect that our research and development expenses may increase if we are successful in advancing our sitravatinib, MRTX849 and our preclinical KRAS G12D program, or any of our other preclinical programs, into more advanced stages of clinical development.

Our research and development efforts during the three months ended March 31, 2019 and 2018 were focused on our clinical development programs and our preclinical programs. The following table summarizes our research and development expenses (in thousands):



	Three months ended March 31,				Increase
	2019		2018		(Decrease)
Third-party research and development expenses:
Clinical development programs:
Sitravatinib	13,729		7,148		6,581
MRTX849	4,622		—		4,622
Mocetinostat	689		1,373		(684		)
Glesatinib	400		2,099		(1,699		)
Pre-clinical development programs:
KRAS inhibitors	4,438		3,689		749
Preclinical and early discovery	787		348		439
Total third-party research and development expenses	24,665		14,657		10,008
Salaries and other employee related expense	3,816		2,790		1,026
Share-based compensation expense	5,157		1,493		3,664
Other research & development costs	602		719		(117		)
Research and development expense	$	34,240	$	19,659	$	14,581

Research and development expenses for the three months ended March 31, 2019 were $34.2 million compared to $19.7 million for the three months ended March 31, 2018 . The increase of $14.6 million primarily relates to increases in third-party development expense of $10.0 million , share-based compensation expense of $3.7 million and salaries and other employee related expense of $1.0 million . The increase in third-party research and development expense relates to an increase in expenses associated with development of sitravatinib of $ 6.6 million and MRTX849 of $4.6 million , offset by decreases in expenses associated with the development of glesatinib and mocetinostat of $1.7 million and $0.7 million , respectively. The increase in development expense for sitravatinib is due to increased manufacturing production expenses, investigator payment expenses, and CRO expenses to support the expansion of existing and new sitravatinib clinical trials. The increase in expenses associated with MRTX849 relates to the Phase 1 clinical trial for this compound which was initiated in the first quarter of 2019 and the costs are comprised largely of manufacturing production expenses and CRO and other clinical trial-related expenses. The decreases in expense associated with glesatinib and mocetinostat are due to the decision to discontinue development for each program. The increase in share-based compensation expense of $3.7 million is due to an increase in the fair value of stock options granted during the three months ended March 31, 2019 compared to the same period in 2018 . The increase in salaries and other employee related expense of $1.0 million is primarily due to an increase in the number of research and development employees employed during the three months ended March 31, 2019 compared to the same period in 2018 .

General and administrative expenses

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General and administrative expenses consist primarily of salaries and related benefits, including share-based compensation, related to our executive, finance, business development, legal and support functions. Other general and administrative expenses include professional fees for auditing and tax services, rent and utilities and insurance.

General and administrative expenses for the three months ended March 31, 2019 and 2018 were $9.8 million and $5.2 million , respectively, resulting in an increase of $4.6 million . The increase is largely due to an increase in share-based compensation expense of $3.8 million due to an increase in the fair value of stock options granted during the three months ended March 31, 2019 compared to the same period in 2018 .

Other Income, Net

Other income, net for the three months ended March 31, 2019 was $1.8 million compared to $0.6 million for the same period in 2018 and consists primarily of interest income. The increase primarily reflects higher average cash balances available for investment.

Liquidity and Capital Resources

At March 31, 2019 , we had $301.0 million of cash, cash equivalents and short-term investments compared to $222.8 million at December 31, 2018 . In January 2019, we completed a public offering of our common stock that generated net cash proceeds of $107.9 million . Based on our current and anticipated level of operations, we believe that our cash, cash equivalents and short-term investments will be sufficient to meet our anticipated obligations for at least one year from the date that this Quarterly Report on Form 10-Q is filed with the SEC.

To date, we have funded our operations primarily through the sale of our common stock, pre-funded warrants to purchase our common stock, and to a lesser extent through up-front payments, research funding and milestone payments under collaborative arrangements. Since inception, we have primarily devoted our resources to funding research and development programs, including discovery research, preclinical and clinical development activities. To fund future operations, we will likely need to raise additional capital. The amount and timing of future funding requirements will depend on many factors, including the timing and results of our ongoing development efforts, the potential expansion of our current development programs, potential new development programs and related general and administrative support. We anticipate that we will seek to fund our operations through public or private equity or debt financings or other sources, such as potential collaboration agreements. We cannot make assurances that anticipated additional financing will be available to us on favorable terms, or at all. Although we have previously been successful in obtaining financing through our equity securities offerings, there can be no assurance that we will be able to do so in the future.

Cash Flows for the Three Months Ended March 31, 2019 and 2018

The following table provides a summary of the net cash flow activity for each of the periods set forth below (in thousands):



	Three months ended March 31,
	2019			2018
Net cash used in operating activities	$	(34,482	)	$	(7,948	)
Net cash used in investing activities	(35,208		)	(85,078		)
Net cash provided by financing activities	111,601			5,890
Increase (decrease) in cash	41,911			(87,136		)

Net cash used in operating activities

Net cash used in operating activities for the three months ended March 31, 2019 was $34.5 million , compared to $7.9 million for the three months ended March 31, 2018 , an increase of $26.5 million . Cash used in operating activities during 2019 primarily related to our net loss of $40.9 million , adjusted for non-cash items such as share-based compensation of $11.1 million and net cash inflows from a change in our operating assets and liabilities of $3.8 million . Cash used in operating activities during 2018 primarily related to our net loss of $14.7 million , adjusted for non-cash items such as share-based compensation expense of $3.7 million and net cash outflows from a change in our operating assets and liabilities of $3.2 million .

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Net cash used in investing activities

For the three months ended March 31, 2019 and March 31, 2018 , investing activities used cash of $35.2 million and $85.1 million , respectively due to purchases of short-term investments, offset by maturities of short-term investments.

Net cash provided by financing activities

Net cash provided by financing activities for the three months ended March 31, 2019 was $111.6 million and consisted of proceeds received from the issuance of common stock, exercise of common stock options, and disgorgement of stockholders' short-swing profits. Net cash provided by financing activities for the three months ended March 31, 2018 was $5.9 million and consisted entirely of proceeds from the exercise of common stock options.

Off-Balance Sheet Arrangements

During the three months ended March 31, 2019 , we did not have any off-balance sheet arrangements (as defined by applicable SEC regulations) that are reasonably likely to have a current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources.

Contractual Obligations and Commitments

There were no material changes outside of the ordinary course of business to our specific contractual obligations during the three months ended March 31, 2019.

Recent Accounting Pronouncements

Occasionally, new accounting standards are issued or proposed by the Financial Accounting Standards Board, or other standard-setting bodies that we adopt by the effective date specified within the standard. Unless otherwise discussed, standards that do not require adoption until a future date are not expected to have a material impact on our financial statements upon adoption.



ITEM 3.	Quantitative and Qualitative Disclosures about Market Risk

Interest Rate Risk

Some of our short-term investments have market risk in that a change in prevailing interest rates may cause the fair value of the principal amount of the investment to fluctuate. Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash, cash equivalents and short-term investments. We invest our excess cash primarily in commercial paper and debt instruments of financial institutions, corporations, U.S. government-sponsored agencies and the U.S. Treasury. We mitigate credit risk by maintaining a well-diversified portfolio and limiting the amount of investment exposure as to institution, maturity and investment type. We invest our excess cash in accordance with our investment policy.

Because of the short-term maturities of our cash equivalents and short-term investments, we do not believe that an increase in market rates would have any significant impact on the realized value of our investments. If a 1% change in interest rates were to have occurred on March 31, 2019 , this change would not have had a material effect on the fair value of our investment portfolio as of that date.

Effects of Inflation

We do not believe that inflation and changing prices had a significant impact on our results of operations for any periods presented herein.



ITEM 4.	Controls and Procedures

Evaluation of Disclosure Controls and Procedures

As required by Rule 13a-15(b) and Rule 15d-15(b) of the Exchange Act, our management, including our principal executive officer and our principal financial officer, conducted an evaluation as of the end of the period covered by this Quarterly Report

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on Form 10-Q of the effectiveness of the design and operation of our disclosure controls and procedures. Based on that evaluation, management has concluded that as of March 31, 2019 , the Company’s disclosure controls and procedures were effective at the reasonable assurance level and we believe the condensed consolidated financial statements included in this Form 10-Q for the three months ended March 31, 2019 present, in all material respects, our financial position, results of operations, comprehensive loss and cash flows for the periods presented in conformity with U.S. generally accepted accounting principles.

Changes in Internal Control over Financial Reporting

As required by Rule 13a-15(d) and Rule 15d-15(d) of the Exchange Act, our management, including our principal executive officer and our principal financial officer, conducted an evaluation of the internal control over financial reporting to determine whether any changes occurred during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Based on that evaluation, our principal executive officer and principal financial officer concluded that there were no changes in our internal controls over financial reporting during the period covered by this Quarterly Report on Form 10-Q that materially affected, or were reasonably likely to materially affect, our internal control over financial reporting.

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PART II-OTHER INFORMATION


ITEM 1.	LEGAL PROCEEDINGS

None.



ITEM 1A.	Risk Factors.

You should consider carefully the following information about the risks described below, together with the other information contained in this Quarterly Report and in our other public filings in evaluating our business. The risk factors set forth below with an asterisk (*) next to the title contain changes to the description of the risk factors associated with our business previously disclosed in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2018 . Additional risks and uncertainties that we are unaware of may also become important factors that affect us. If any of the following risks actually occurs, our business, financial condition, results of operations and future growth prospects would likely be materially and adversely affected. In these circumstances, the market price of our common stock would likely decline.

Risks Relating to Our Financial Position and Capital Requirements

* We will require additional financing and may be unable to raise sufficient capital, which could lead us to delay, reduce or abandon development programs or commercialization.

Our operations have consumed substantial amounts of cash since inception. Our research and development expenses were $34.2 million and $19.7 million for the three months ended March 31, 2019 and 2018 , respectively. We will require substantial additional capital to pursue additional clinical development for our lead clinical programs, including conducting late-stage clinical trials, manufacturing clinical supplies and potentially developing other assets in our pipeline, and, if we are successful, to commercialize any of our current product candidates. If the U.S. Food and Drug Administration ("FDA") or any foreign regulatory agency, such as the European Medicines Agency ("EMA") requires that we perform studies or trials in addition to those that we currently anticipate with respect to the development of our product candidates, or repeat studies or trials, our expenses would further increase beyond what we currently expect. We may not be able to adequately finance our development programs, which could limit our ability to move our programs forward in a timely and satisfactory manner or require us to abandon the programs, any of which would harm our business, financial condition and results of operations. Because successful development of our product candidates is uncertain, we are unable to estimate the actual funds we will require to complete research and development and commercialize our product candidates.

If we are unable to obtain funding from equity offerings or debt financings on a timely basis, we may be required to (1) seek additional collaborators for one or more of our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; (2) relinquish or license on unfavorable terms our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves; or (3) significantly curtail one or more of our research or development programs or cease operations altogether.

We are a clinical-stage company with no approved products and no historical product revenue. Consequently, we expect that our financial and operating results will vary significantly from period to period.

We are a clinical-stage company that has incurred losses since its inception and expect to continue to incur substantial losses in the foreseeable future. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty.

Our actual financial condition and operating results have varied significantly in the past and are expected to continue to fluctuate significantly from quarter-to-quarter or year-to-year due to a variety of factors, many of which are beyond our control. Factors relating to our business that may contribute to these fluctuations include:


•	the success of our clinical trials through all phases of clinical development;


•	delays in the commencement, enrollment and timing of clinical trials;


•	our ability to secure and maintain collaborations, licensing or other arrangements for the future development and/or commercialization of our product candidates, as well as the terms of those arrangements;

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•	our ability to obtain, as well as the timeliness of obtaining, additional funding to develop our product candidates;


•	the results of clinical trials or marketing applications for product candidates that may compete with our product candidates;


•	competition from existing products or new products that may receive marketing approval;


•	potential side effects of our product candidates that could delay or prevent approval or cause an approved drug to be taken off the market;


•	any delays in regulatory review and approval of our clinical development plans or product candidates;


•	our ability to identify and develop additional product candidates;


•	the ability of patients or healthcare providers to obtain coverage or sufficient reimbursement for our products;


•	our ability, and the ability of third parties such as Clinical Research Organizations ("CROs") to adhere to clinical study and other regulatory requirements;


•	the ability of third-party manufacturers to manufacture our product candidates and key ingredients needed to conduct clinical trials and, if approved, successfully commercialize our products;


•	the costs to us, and our ability as well as the ability of any third-party collaborators, to obtain, maintain and protect our intellectual property rights;


•	costs related to and outcomes of potential intellectual property litigation;


•	our ability to adequately support future growth;


•	our ability to attract and retain key personnel to manage our business effectively; and


•	our ability to build our finance infrastructure and, to the extent required, improve our accounting systems and controls.

Accordingly, the likelihood of our success must be evaluated in light of many potential challenges and variables associated with a clinical-stage company, many of which are outside of our control, and past operating or financial results should not be relied on as an indication of future results. Fluctuations in our operating and financial results could cause our share price to decline. It is possible that in some future periods, our operating results will be above or below the expectations of securities analysts or investors, which could also cause our share price to decline.

* We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future. We have never generated any revenue from product sales and may never be profitable.

We have derived limited revenue from our research, collaboration and licensing agreements which has not been sufficient to cover the substantial expenses we have incurred in our efforts to develop our product candidates. Consequently, we have accumulated net losses since inception in 1995. Our net loss for the three months ended March 31, 2019 and 2018 was $40.9 million and $14.7 million , respectively. As of March 31, 2019 , we had an accumulated deficit of $600.0 million . Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders' equity and working capital. Such losses are expected to increase in the future as we continue the development of our product candidates and seek regulatory approval and commercialization for our product candidates. We are unable to predict the extent of any future losses or when we will become profitable, if ever. Even if we do achieve profitability, we may not be able to sustain or increase profitability on an ongoing basis.

We do not anticipate generating revenue from sales of products for the foreseeable future, if ever. If any of our product candidates fail in clinical trials or do not gain regulatory approval, or if any of our product candidates, if approved, fail to achieve market acceptance, we may never become profitable. If one or more of our product candidates is approved for commercial sale and we retain commercial rights, we anticipate incurring significant costs associated with commercializing any such approved product candidate. Therefore, even if we are able to generate revenue from the sale of any approved product, we may never become profitable. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. Our ability to generate future revenue from product sales depends heavily on our success in:

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•	completing development and clinical trial programs for our product candidates;


•	maintaining existing collaboration and licensing agreements and entering into additional ones;


•	seeking and obtaining marketing approvals for any product candidates that successfully complete clinical trials;


•	establishing and maintaining supply and manufacturing relationships with third parties;


•	successfully commercializing any product candidates for which marketing approval is obtained; and


•	successfully establishing a sales force and marketing and distribution infrastructure.

Raising additional funds through debt or equity financing will be dilutive and raising funds through licensing agreements may be dilutive, restrict operations or relinquish proprietary rights.

To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of those securities could result in substantial dilution for our current stockholders and the terms may include liquidation or other preferences that adversely affect the rights of our current stockholders. Existing stockholders may not agree with our financing plans or the terms of such financings. Moreover, the incurrence of debt financing could result in a substantial portion of our operating cash flow being dedicated to the payment of principal and interest on such indebtedness and could impose restrictions on our operations. In addition, if we raise additional funds through future collaboration and licensing arrangements, it may be necessary to relinquish potentially valuable rights to our products or proprietary technologies, or to grant licenses on terms that are not favorable to us. Additional funding may not be available to us on acceptable terms, or at all.

As a public company in the United States, we incur significant legal and financial compliance costs and we are subject to the Sarbanes-Oxley Act. We can provide no assurance that we will, at all times, in the future be able to report that our internal controls over financial reporting are effective.

Companies that file reports with the Securities and Exchange Commission ("SEC"), including us, are subject to the requirements of Section 404 of the Sarbanes-Oxley Act of 2002. Section 404 requires management to establish and maintain a system of internal control over financial reporting, and annual reports on Form 10-K filed under the Securities Exchange Act of 1934, as amended ("the Exchange Act"), must contain a report from management assessing the effectiveness of a company’s internal control over financial reporting. Ensuring that we have adequate internal financial and accounting controls and procedures in place to produce accurate financial statements on a timely basis remains a costly and time-consuming effort that needs to be re-evaluated frequently. Failure on our part to have effective internal financial and accounting controls would cause our financial reporting to be unreliable, could have a material adverse effect on our business, operating results, and financial condition, and could cause our stock price to decline as a result.

If we cannot conclude that we have effective internal control over our financial reporting, or if our independent registered public accounting firm is unable to provide an unqualified opinion regarding the effectiveness of our internal control over financial reporting, investors could lose confidence in the reliability of our financial statements. Failure to comply with reporting requirements could also subject us to sanctions and/or investigations by the SEC, The NASDAQ Global Select Market or other regulatory authorities.

Furthermore, shareholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact the manner in which we operate our business in ways we cannot currently anticipate. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, any new regulations or disclosure obligations may increase our legal and financial compliance costs and will make some activities more time-consuming and costly.

The timing of the milestone and royalty payments we are entitled to receive from BeiGene, Ltd. is uncertain and could adversely affect our cash flows and results of operations.

In January 2018 we entered into a collaboration and license agreement with BeiGene, Ltd. (“BeiGene”) (the “BeiGene Agreement”), pursuant to which we agreed to collaboratively develop sitravatinib in Asia (excluding Japan and certain other countries), Australia and New Zealand (the “BeiGene Territory”) and we granted BeiGene an exclusive license to develop, manufacture and commercialize sitravatinib in the BeiGene Territory. In addition to an up-front payment, we may be entitled to receive additional payments upon the achievement of certain milestones under the BeiGene Agreement. However, the receipt of

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these payments is inherently uncertain. The receipt of milestone payments under the BeiGene Agreement can have a significant impact on our cash flows and results of operations for the periods of time in which such payments are made. While receipt of milestone and royalty payments would result in significant income, the absence of collaboration revenues in subsequent quarters could result in significant reductions in net income and could cause our stock price to drop.

U.S. federal income tax reform bill could adversely affect our business and financial condition.

On December 22, 2017, U.S. federal income tax legislation was signed into law (H.R. 1, “An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018”, informally titled the Tax Cuts and Jobs Act, or the Tax Act) that significantly revises the Internal Revenue Code of 1986, as amended. The Tax Act, among other things, contains significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21%, repeal of the alternative minimum tax for corporations, limitation of the tax deduction for interest expense to 30% of adjusted earnings (except for certain small businesses), limitation of the deduction for net operating losses to 80% of current year taxable income and elimination of net operating loss carrybacks, one time taxation of offshore earnings at reduced rates regardless of whether they are repatriated, elimination of U.S. tax on foreign earnings (subject to certain important exceptions), immediate deductions for certain new investments instead of deductions for depreciation expense over time, and modifying or repealing many business deductions and credits. Notwithstanding the reduction in the corporate income tax rate, the overall impact of the Tax Act is uncertain and our business and financial condition could be adversely affected. In addition, it is uncertain if and to what extent various states will conform to the Tax Act. The impact of the Tax Act on holders of our common stock is also uncertain and could be adverse.

Our ability to use our U.S. net operating loss carryforwards and certain other tax attributes may be limited.

Our U.S. net operating loss, or NOL, carryforwards generated in tax years ending on or prior to December 31, 2017, are only permitted to be carried forward for 20 years under applicable U.S. tax law. Under the Tax Act, our federal NOLs generated in tax years ending after December 31, 2017, may be carried forward indefinitely, but the deductibility of such federal NOLs generated in tax years beginning after December 31, 2017, is limited. It is uncertain if and to what extent various states will conform to the Tax Act. In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in its equity ownership over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change U.S. tax attributes (such as research tax credits) to offset its post-change income or taxes may be limited. We believe we have experienced at least one ownership change based on past financing transactions and may experience ownership changes in the future as a result of subsequent shifts in our stock ownership.

As a result, our pre-2018 NOL carryforwards may expire prior to being used, and our NOL carryforwards generated in 2018 and thereafter will be subject to a percentage limitation. In addition, it is possible that we have in the past undergone, and in the future may undergo, additional ownership changes that could limit our ability to use all of our pre-change NOLs and other pre-change tax attributes (such as research tax credits) to offset our post-change income or taxes. Similar provisions of state tax law may also apply to limit our use of accumulated state tax attributes. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. As a result, we may be unable to use all or a material portion of our NOLs and other tax attributes, which could adversely affect our future cash flows.

Risks Relating to Our Business and Industry

* Our research and development programs and product candidates are at an early stage of development. As a result, we are unable to predict if or when we will successfully develop or commercialize our product candidates.

Our clinical-stage product candidates as well as our other pipeline assets are at an early stage of development and will require significant further investment and regulatory approvals prior to commercialization. Sitravatinib is in a Phase 1b single agent clinical trial and a Phase 2 combination clinical trial, and a Phase 3 combination clinical trial is expected to be initiated in the second quarter of 2019. MRTX849 is in a Phase 1/2 clinical trial and we have a KRAS G12D inhibitor preclinical program. Each of our product candidates will require the selection of suitable patients for our clinical trials and additional clinical development, management of clinical, preclinical and manufacturing activities, obtaining regulatory approval, obtaining manufacturing supply, building of a commercial organization, substantial investment and significant marketing efforts before we generate any revenues from product sales. We are not permitted to market or promote any of our product candidates before we receive regulatory approval from the FDA or comparable foreign regulatory authorities, and we may never receive such regulatory approval for any of our product candidates. The treatment of cancer is a rapidly evolving field and will continue to evolve. By such time, if ever, as we may receive necessary regulatory approvals for our product candidates, the standard of care for the

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treatment of cancers may have evolved such that it would be necessary to modify our plans for full approval and commercial acceptance of our products may be limited by a change in the standard of care. In addition, some of our product development programs contemplate the development of companion diagnostics. Companion diagnostics are subject to regulation as medical devices and we or our future collaborators may be required to obtain marketing approval for accompanying companion diagnostics before we may commercialize our product candidates.

Even if we obtain the required financing or establish a collaboration to enable us to conduct late-stage clinical development of our product candidates and pipeline assets, we cannot be certain that such clinical development would be successful, or that we will obtain regulatory approval or be able to successfully commercialize any of our product candidates and generate revenue. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and the clinical trial process may fail to demonstrate that our product candidates are safe and effective for their proposed uses. Any such failure could cause us to abandon further development of any one or more of our product candidates and may delay development of other product candidates. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. Any delay in, or termination of, our clinical trials will delay and possibly preclude the submission of any new drug applications ("NDAs") with the FDA and, ultimately, our ability to commercialize our product candidates and generate product revenue.

We have not previously submitted an NDA to the FDA, or similar drug approval filings to comparable foreign authorities, for any product candidate, and we cannot be certain that any of our product candidates will receive regulatory approval. Further, our product candidates may not receive regulatory approval even if they are successful in clinical trials. If we do not receive regulatory approvals for our product candidates, we may not be able to continue our operations. Even if we successfully obtain regulatory approvals to market one or more of our product candidates, our revenues will be dependent, in part, upon our or our collaborators' and future collaborators’ ability to obtain regulatory approval for the companion diagnostics to be used with our product candidates, if required, and upon the size of the markets in the territories for which we gain regulatory approval and have commercial rights. If the markets for patient subsets that we are targeting are not as significant as we estimate, we may not generate significant revenues from sales of such products, if approved.

All of our product candidates are subject to extensive regulation, which can be costly and time consuming, cause delays or prevent approval of such product candidates for commercialization.

The clinical development of product candidates is subject to extensive regulation by the FDA in the United States and by comparable regulatory authorities in foreign markets. Product development is a very lengthy and expensive process, and its outcome is inherently uncertain. The product development timeline can vary significantly based upon the product candidate’s novelty and complexity. Regulations are subject to change and regulatory agencies have significant discretion in the approval process.

Numerous statutes and regulations govern human testing and the manufacture and sale of human therapeutic products in the United States, Europe and other countries and regions where we intend to market our products. Such legislation and regulation bears upon, among other things, the approval of trial protocols and human testing, the approval of manufacturing facilities, safety of the product candidates, testing procedures and controlled research, review and approval of manufacturing, preclinical and clinical data prior to marketing approval including adherence to good manufacturing practices ("GMP") during production and storage as well as regulation of marketing activities including advertising and labeling.

In order to obtain regulatory approval for the commercial sale of any of our product candidates, we must demonstrate through preclinical studies and clinical trials that the potential product is safe and effective for use in humans for each target indication. The failure to adequately demonstrate the safety and efficacy of a product under development could delay or prevent regulatory approval of our product candidates.

No assurance can be given that current regulations relating to regulatory approval will not change or become more stringent in the United States or foreign markets. Regulatory agencies may also require that additional trials be run in order to provide additional information regarding the safety or efficacy of any drug candidates for which we seek regulatory approval. Moreover, any regulatory approval of a drug which is eventually obtained may entail limitations on the indicated uses for which that drug may be marketed. Furthermore, product approvals may be withdrawn or limited in some way if problems occur following initial marketing or if compliance with regulatory standards is not maintained. Regulatory agencies could become more risk averse to any side effects or set higher standards of safety and efficacy prior to reviewing or approving a product. This could result in a product not being approved. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates.

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The failure to maintain the BeiGene Agreement or the failure of BeiGene to perform its obligations under the BeiGene Agreement, could negatively impact our business.

Pursuant to the terms of the BeiGene Agreement, we granted to BeiGene an exclusive license to develop, manufacture and commercialize sitravatinib in the BeiGene Territory. Consequently, our ability to generate any revenues from sitravatinib in the BeiGene Territory depends on our ability to maintain our collaboration with BeiGene. We have limited control over the amount and timing of resources that BeiGene will dedicate to these efforts.

We are subject to a number of other risks associated with our dependence on the BeiGene Agreement with respect to sitravatinib in the BeiGene Territory, including:


•	BeiGene may not comply with applicable regulatory guidelines with respect to developing, manufacturing or commercializing sitravatinib, which could adversely impact sales or future development of sitravatinib in the BeiGene Territory or elsewhere;


•	We and BeiGene could disagree as to future development plans and BeiGene may delay, fail to commence or stop future clinical trials or other development;

•

There may be disputes between us and BeiGene, including disagreements regarding the BeiGene Agreement, that may result in (1) the delay of or failure to achieve developmental, regulatory and commercial objectives that would result in milestone or royalty payments, (2) the delay or termination of any future development or commercialization of sitravatinib in the BeiGene Territory, and/or (3) costly litigation or arbitration that diverts our management’s attention and resources;


•	BeiGene may not provide us with timely and accurate information regarding development, sales and marketing activities or supply forecasts, which could adversely impact our ability to comply with our obligations to BeiGene and manage our own inventory of sitravatinib, as well as our ability to generate accurate financial forecasts;


•	Business combinations or significant changes in BeiGene’ business strategy may adversely affect BeiGene’ ability or willingness to perform its obligations under the BeiGene Agreement; and


•	BeiGene may not properly defend our intellectual property rights, or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or expose us to potential litigation.

The BeiGene Agreement is also subject to early termination, including through BeiGene’s right to terminate without cause upon advance notice to us. If the agreement is terminated early, we may not be able to find another collaborator for the further development and commercialization of sitravatinib in the BeiGene Territory on acceptable terms, or at all, and we may be unable to pursue continued development and commercialization of sitravatinib in the BeiGene Territory on our own.

We may not be successful in establishing development and commercialization collaborations which could adversely affect, and potentially prohibit, our ability to develop our product candidates.

Developing pharmaceutical products, conducting clinical trials, obtaining regulatory approval, establishing manufacturing capabilities and marketing approved products is expensive, and therefore we may seek to enter into additional collaborations with companies that have more resources and experience in order to continue to develop and commercialize our product candidates. We also may be required due to financial or scientific constraints to enter into additional collaboration agreements to research and/or to develop and commercialize our product candidates. The establishment and realization of such collaborations may not be possible or may be problematic. There can be no assurance that we will be able to establish such additional collaborations on favorable terms, if at all, or that our current or future collaborative arrangements will be successful or maintained for any specific product candidate or indication. If we are unable to reach successful agreements with suitable collaboration partners for the ongoing development and commercialization of our product candidates, we may face increased costs, we may be forced to limit the scope and number of our product candidates we can commercially develop or the territories in which we commercialize such product candidates, and we may be unable to commercialize products or programs for which a suitable collaboration partner cannot be found. If we fail to achieve successful collaborations, our operating results and financial condition will be materially and adversely affected.

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In addition, the terms of any collaboration agreements may place restrictions on our activities with respect to other products, including by limiting our ability to grant licenses or develop products with other third parties, or in different indications, diseases or geographical locations, or may place additional obligations on us with respect to development or commercialization of our product candidates. If we fail to comply with or breach any provision of a collaboration agreement, a collaborator may have the right to terminate, in whole or in part, such agreement or to seek damages.

Some of our collaboration agreements, including the BeiGene Agreement, are complex and involve sharing or division of ownership of certain data, know-how and intellectual property rights among the various parties. Accordingly, our collaborators could interpret certain provisions differently than we or our other collaborators which could lead to unexpected or inadvertent disputes with collaborators. In addition, these agreements might make additional collaborations, partnering or mergers and acquisitions difficult.

There is no assurance that a collaborator who is acquired by a third party would not attempt to change certain contract provisions that could negatively affect our collaboration. The acquiring company may also not accept the terms or assignment of our contracts and may seek to terminate the agreements. Any one of our collaborators could breach covenants, restrictions and/or sub-license agreement provisions leading us into disputes and potential breaches of our agreements with other partners.

If we or third parties are unable to successfully develop companion diagnostics for our product candidates, or experience significant delays in doing so, we may not achieve marketing approval or realize the full commercial potential of such product candidates.

A key part of our development strategy for our product candidates is to identify subsets of patients with specific types of tumors that express specific genetic markers. Identification of these patients will require the use and development of companion diagnostics. The FDA generally will either require approval or clearance of the diagnostic at the same time the FDA approves the therapeutic product, or as a post-marketing commitment at the time of the therapeutic product's approval. We do not have experience or capabilities in developing or commercializing diagnostics and plan to rely in large part on third parties to perform these functions. We do not currently have any long-term arrangements in place with any third party to develop or commercialize companion diagnostics for our product candidates.

Companion diagnostics are subject to regulation by the FDA and comparable foreign regulatory authorities as medical devices and will likely require separate regulatory approval prior to commercialization. If we or third parties are unable to successfully develop companion diagnostics for our product candidates, or experience delays in doing so:


•	the development of these product candidates may be delayed because it may be difficult to identify patients for enrollment in our clinical trials in a timely manner;


•	these product candidates may not receive marketing approval if their safe and effective use depends on a companion diagnostic; and


•	we may not realize the full commercial potential of these product candidates that receive marketing approval if, among other reasons, we are unable to appropriately identify patients or types of tumors with the specific genetic alterations targeted by these product candidates.

Even if our product candidates and any associated companion diagnostics are approved for marketing, the need for companion diagnostics may slow or limit adoption of our product candidates. Although we believe genetic testing is becoming more prevalent in the diagnosis and treatment of cancer, our product candidates may be perceived negatively compared to alternative treatments that do not require the use of companion diagnostics, either due to the additional cost of the companion diagnostic or the need to complete additional procedures to identify genetic markers prior to administering our product candidates.

If any of these events were to occur, our business and growth prospects would be harmed, possibly materially.

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We rely upon third-party contractors and service providers for the execution of some aspects of our development programs. Failure of these collaborators to provide services of a suitable quality and within acceptable timeframes may cause the delay or failure of our development programs.

We outsource certain functions, tests and services to CROs, medical institutions and collaborators and outsource manufacturing to collaborators and/or contract manufacturers, and we rely on third parties for quality assurance, clinical monitoring, clinical data management and regulatory expertise. In particular, we rely on CROs to run our clinical trials on our behalf and contract manufacturers to manufacture our product candidates. There is no assurance that such individuals or organizations will be able to provide the functions, tests, drug supply or services as agreed upon or to acceptable quality standards, and we could suffer significant delays in the development of our products or processes.

In some cases, there may be only one or few providers of such services, including manufacturing services. In addition, the cost of such services could increase significantly over time. We rely on third parties as mentioned above to enroll qualified patients and conduct, supervise and monitor our clinical trials. Our reliance on these third parties and collaborators for clinical development activities reduces our control over these activities, but does not relieve us of our regulatory responsibilities, including ensuring that our clinical trials are conducted in accordance with good clinical practices ("GCP") regulations and the investigational plan and protocols contained in the regulatory agency applications. In addition, these third parties may not complete activities on schedule or may not manufacture compounds under GMP conditions. Preclinical studies may not be performed or completed in accordance with good laboratory practices, or GLP, regulatory requirements or our trial design. If we or our CROs fail to comply with GCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, the EMA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving any marketing applications. If these third parties or collaborators do not successfully carry out their contractual duties or meet expected deadlines, obtaining regulatory approval for manufacturing and commercialization of our product candidates may be delayed or prevented. We rely substantially on third-party data managers for our clinical trial data. There is no assurance that these third parties will not make errors in the design, management or retention of our data or data systems. There is no assurance that these third parties will pass FDA or regulatory audits, which could delay or prohibit regulatory approval.

Our CROs may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other product development activities, which could harm our competitive position. If any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or to do so on commercially reasonable terms. Further, switching or adding additional CROs involves additional cost and requires management time and attention. In addition, there is a natural transition period when a new CRO commences work. As a result, delays may occur, which could materially impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

The timelines of our clinical trials may be impacted by numerous factors and any delays may adversely affect our ability to execute our current business strategy.

Clinical testing is expensive, difficult to design and implement, can take many years to complete, and is uncertain as to outcome. We may experience delays in clinical trials at any stage of development and testing of our product candidates. Our planned clinical trials may not begin on time, have an effective design, enroll a sufficient number of subjects, or be completed on schedule, if at all.

Events which may result in a delay or unsuccessful completion of clinical trials include:


•	inability to raise funding necessary to initiate or continue a trial;


•	delays in obtaining regulatory approval to commence a trial;


•	delays in reaching agreement with the FDA on final trial design;


•	imposition of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities;


•	delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;


•	delays in obtaining required institutional review board approval at each site;

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•	delays in having subjects complete participation in a trial or return for post-treatment follow-up;


•	delays caused by subjects dropping out of a trial due to side effects or otherwise;


•	clinical sites dropping out of a trial to the detriment of enrollment;


•	time required to add new clinical sites; and


•	delays by our contract manufacturers to produce and deliver a sufficient supply of clinical trial materials.

Furthermore, enrollment may depend on the availability of suitable companion diagnostics to identify genetic markers we are targeting and the capability and willingness of clinical sites to conduct genetic screening of potential patients.

If initiation or completion of any of our clinical trials for our product candidates are delayed for any of the above reasons or for other reasons, our development costs may increase, our approval process could be delayed, any periods after commercial launch and before expiration of patent protection may be reduced and our competitors may have more time to bring products to market before we do. Any of these events could impair the commercial potential of our product candidates and could have a material adverse effect on our business.

If we experience delays or difficulties in the enrollment of patients in clinical trials, those clinical trials could take longer than expected to complete and our receipt of necessary regulatory approvals could be delayed or prevented.

We may not be able to initiate or complete clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials. In particular, because we are focused on patients with specific genetic alterations in some of our trials, our pool of suitable patients may be smaller and more selective and our ability to enroll a sufficient number of suitable patients may be limited or take longer than anticipated. In addition, some of our competitors have ongoing clinical trials for product candidates that treat the same indications, including NSCLC, where we are studying sitravatinib in combination with checkpoint inhibitors, or target the same genetic alterations as our product candidates. Therefore, patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product candidates.

Patient enrollment for any of our clinical trials may also be affected by other factors, including without limitation:


•	the severity of the disease under investigation


•	the frequency of the genetic alteration we are seeking to target in the applicable trial, and the ability to effectively identify such alteration;


•	the willingness of clinical sites and principal investigators to subject candidate patients to genetic screening;


•	the eligibility criteria for the study in question;


•	the perceived risks and benefits of the product candidate under study;


•	the availability, effectiveness and safety of other treatment options;


•	the patient referral practices of physicians;


•	the ability to monitor patients adequately during and after treatment; and


•	the proximity and availability of a sufficient number of clinical trial sites that are willing to comply with the requirements of our clinical protocols.

For example, due to the targeted indications and patient populations we intend to focus on for development of our product candidates, the number of study sites and patient populations available to us may be limited, and therefore enrollment of suitable patients to participate in clinical trials for these product candidates may take longer than would be the case if we were pursuing broader indications or patient populations.

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Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved product label, or result in significant negative consequences following marketing approval, if any.

Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. Results of our trials could reveal a high and unacceptable severity and prevalence of side effects. In such an event, our trials could be suspended or terminated and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of our product candidates for any or all targeted indications. Treatment-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial, or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly.

Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including:


•	regulatory authorities may withdraw approvals of such product;


•	regulatory authorities may require additional warnings on the product label;


•	we may be required to create a medication guide outlining the risks of such side effects for distribution to patients;


•	we could be sued and held liable for harm caused to patients; and


•	our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of any product candidate, if approved, and could significantly harm our business, results of operations and prospects.

We are and continue to be subject to stringent government regulations concerning the clinical testing of our products. We will also continue to be subject to government regulation of any product that receives regulatory approval.

Numerous statutes and regulations govern human testing and the manufacture and sale of human therapeutic products in the United States and other countries where we intend to market our products. Such legislation and regulation bears upon, among other things, the approval of trial protocols and human testing, the approval of manufacturing facilities, testing procedures and controlled research, the review and approval of manufacturing, preclinical and clinical data prior to marketing approval, including adherence to GMP during production and storage, and marketing activities including advertising and labeling.

Clinical trials may be delayed or suspended at any time by us or by the FDA or other similar regulatory authorities if it is determined at any time that patients may be or are being exposed to unacceptable health risks, including the risk of death, or if compounds are not manufactured under acceptable GMP conditions or with acceptable quality. Current regulations relating to regulatory approval may change or become more stringent. The agencies may also require additional trials be run in order to provide additional information regarding the safety, efficacy or equivalency of any product candidate for which we seek regulatory approval.

Moreover, any regulatory approval of a drug which is eventually obtained may entail limitations on the indicated uses for which that drug may be marketed or on the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product candidate. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with GMPs and GCPs for any clinical trials that we conduct post-approval. In addition, if the FDA or a comparable foreign regulatory authority approves any of our product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. For example, the FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability. Furthermore, product approvals may be withdrawn or limited in some way if problems occur following initial marketing or if compliance with regulatory standards is not maintained. Similar restrictions are imposed in foreign markets. Regulatory agencies could become more risk averse to any side effects or set higher standards of safety and efficacy prior to reviewing or approving a product. This could result in a product not being approved.

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If we, or any future marketing collaborators or contract manufacturers, fail to comply with applicable regulatory requirements, we may be subject to sanctions including fines, product recalls or seizures and related publicity requirements, injunctions, total or partial suspension of production, civil penalties, suspension or withdrawals of previously granted regulatory approvals, warning or untitled letters, refusal to approve pending applications for marketing approval of new products or of supplements to approved applications, import or export bans or restrictions, and criminal prosecution and penalties. Any of these penalties could delay or prevent the promotion, marketing or sale of our products and product candidates.

The FDA’s policies, and policies of comparable foreign regulatory authorities, may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. If we are slow or unable to adapt to changes in existing requirements or to adopt new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.

We have no experience in clinical or commercial manufacturing and depend on others for the production of our product candidates at suitable levels of quality and quantity. Any problems or delays in the manufacture of our products would have a negative impact on our ability to successfully execute our development and commercialization strategies.

We do not currently have nor do we plan to acquire the infrastructure or capability internally to manufacture our clinical drug supplies for use in the conduct of our clinical trials, and we lack the resources and the capability to manufacture any of our product candidates on a clinical or commercial scale. We rely on collaborators and/or third parties for development, scale-up, formulation, optimization, management of clinical trial and commercial scale manufacturing and commercialization. There are no assurances we can scale-up, formulate or manufacture any product candidate in sufficient quantities with acceptable specifications for the conduct of our clinical trials or for the regulatory agencies to grant approval of such product candidate. We have not yet commercialized any products and have no commercial manufacturing experience. To be successful, our products must be properly formulated, scalable, stable and safely manufactured in clinical trial and commercial quantities in compliance with GMP and other regulatory requirements and at acceptable costs. Should any of our suppliers or our collaborators be unable to supply or be delayed in supplying us with sufficient supplies, no assurance can be given that we will be able to find alternative means of supply in a short period of time. Should such parties’ operations suffer a material adverse effect, the manufacturing of our products would also be adversely affected. Furthermore, key raw materials could become scarce or unavailable. There may be a limited number of third parties who can manufacture our products. We may not be able to meet specifications previously established for product candidates during scale-up and manufacturing.

Our reliance on third parties to manufacture our product candidates will expose us and our partners to risks including the following, any of which could delay or prevent the commercialization of our products, result in higher costs, or deprive us of potential product revenue:

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Contract manufacturers can encounter difficulties in achieving the scale-up, optimization, formulation, or volume production of a compound as well as maintaining quality control with appropriate quality assurance. They may also experience shortages of qualified personnel. Contract manufacturers are required to undergo a satisfactory GMP inspection prior to regulatory approval and are obliged to operate in accordance with FDA, International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ("ICH"), European and other nationally mandated GMP regulations and/or guidelines governing manufacturing processes, stability testing, record keeping and quality standards. A failure of these contract manufacturers to follow GMP and to document their adherence to such practices or failure of an inspection by a regulatory agency may lead to significant delays in the availability of our product candidate materials for clinical study, leading to delays in our trials.

•

For each of our current product candidates we will initially rely on a limited number of contract manufacturers. Changing these or identifying future manufacturers may be difficult. Changing manufacturers requires re-validation of the manufacturing processes and procedures in accordance with FDA, ICH, European and other mandated GMP regulations and/or guidelines. Such re-validation may be costly and time-consuming. It may be difficult or impossible for us to quickly find replacement manufacturers on acceptable terms.


•	Our contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to produce, store and distribute our products successfully.

The successful commercialization of our product candidates, if approved, will depend on achieving market acceptance and we may not be able to gain sufficient acceptance to generate significant revenue.

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Even if our product candidates are successfully developed and receive regulatory approval, they may not gain market acceptance among physicians, patients, healthcare payors such as private insurers or governments and other funding parties and the medical community. The degree of market acceptance for any of our products will depend on a number of factors, including:


•	demonstration of the clinical efficacy and safety of our products;


•	the prevalence and severity of any adverse side effects;


•	limitations or warnings contained in the product’s approved labeling;


•	cost-effectiveness and availability of acceptable pricing;


•	competitive product profile versus alternative treatment methods and the superiority of alternative treatment or therapeutics;


•	the effectiveness of marketing and distribution methods and support for the products; and


•	coverage and reimbursement policies of government and third-party payors to the extent that our products could receive regulatory approval but not be approved for coverage by or receive adequate reimbursement from government and quasi-government agencies or other third-party payors.

Disease indications may be small subsets of a disease that could be parsed into smaller and smaller indications as different subsets of diseases are defined. This increasingly fine characterization of diseases could have negative consequences; including creating an approved indication that is so small as not to have a viable market for us. If future technology allows characterization of a disease in a way that is different from the characterization used for large pivotal studies, it may make those studies invalid or reduce their usefulness, and may require repeating all or a portion of the studies. Future technology may supply better prognostic ability which could reduce the portion of patients projected to need a new therapy. Even after being cleared by regulatory authorities, a product may later be shown to be unsafe or not to have its purported effect, thereby preventing its widespread use or requiring withdrawal from the market.

If we fail to obtain coverage and adequate reimbursement for our products, our revenue-generating ability will be diminished and there is no assurance that the anticipated market for our products will be sustained.

We believe that there will be many different applications for products successfully derived from our technologies and that the anticipated market for products under development will continue to expand. However, due to competition from existing or new products and the yet-to-be established commercial viability of our products, no assurance can be given that these beliefs will prove to be correct. Physicians, patients, formularies, payors or the medical community in general may not accept or utilize any products that we or our collaborative partners may develop. Other drugs may be approved during our clinical testing which could change the accepted treatments for the disease targeted and make our product candidates obsolete.

Our and our collaborators’ ability to commercialize our products successfully will depend, in part, on the extent to which coverage and adequate reimbursement for such products and related treatments will be available from governmental health payor programs at the federal and state levels, including Medicare and Medicaid, private health insurers, managed care plans and other organizations. No assurance can be given that third-party payor coverage and adequate reimbursement will be available that will allow us to maintain price levels sufficient for the realization of an appropriate return on our investment in product development.

Coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and private health insurers, managed care plans and other organizations is critical to new product acceptance. There is no uniform coverage and reimbursement policy among third-party payors in the United States; however, private third-party payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates. Additionally, coverage decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become available. Even if we obtain coverage for our product candidates, the resulting reimbursement payment rates might not be adequate or may require co-payments that patients find unacceptably high. Patients are unlikely to use our product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our product candidates.

Additionally, we or our collaborators may develop companion diagnostic tests for use with our product candidates. We or our collaborators will be required to obtain coverage and reimbursement for these tests separate and apart from the coverage and reimbursement we seek for our product candidates, once approved. While we have not yet developed any companion diagnostic

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test for use with our product candidates, if we do, there is significant uncertainty regarding our ability to obtain coverage and adequate reimbursement for the same reasons applicable to our product candidates.

In the United States and in many other countries, pricing and/or profitability of some or all prescription pharmaceuticals and biopharmaceuticals are subject to varying degrees of government control. In the United States, there has recently been increased government enforcement and government and payor scrutiny relating to drug pricing and price increases. For example, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. For example, at the federal level, on May 11, 2018, President Trump laid out his administration’s “Blueprint” to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of drug products paid by consumers. On January 31, 2019, the Department of Health and Human Services Office of Inspector General proposed modifications to federal Anti-Kickback Statute safe harbors which, among other things, if finalized, will affect discounts paid by manufacturers to Medicare Part D plans, Medicaid managed care organizations and pharmacy benefit managers working with these organizations. Although some of these and other proposals may require additional authorization to become effective, Congress and the Trump Administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. These changes may adversely impact the prices we or our future collaborators may charge for our products candidates, if commercialized.

Outside of the United States, the successful commercialization of our products will depend largely on obtaining and maintaining government coverage, because in many countries patients are unlikely to use prescription drugs that are not covered by their government healthcare programs. Negotiating coverage and reimbursement with governmental authorities can delay commercialization by 12 months or more. Coverage and reimbursement policies may adversely affect our ability to sell our products on a profitable basis. In many international markets, governments control the prices of prescription pharmaceuticals, including through the implementation of reference pricing, price cuts, rebates, revenue-related taxes and profit control, and we expect prices of prescription pharmaceuticals to decline over the life of the product or as volumes increase.

Healthcare reform and controls on healthcare spending may limit the price we charge for any products and the amounts thereof that we can sell. In particular, in the United States, the federal government and private insurers have changed and have considered ways to change, the manner in which healthcare services are provided. In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, "ACA") became law in the United States. With respect to pharmaceutical products, the ACA, among other things, expanded and increased industry rebates for drugs covered by Medicaid and made changes to the coverage requirements under Medicare Part D, Medicare’s prescription drug benefits program. Some of the provisions of the ACA have yet to be fully implemented, and there have been judicial and Congressional challenges to certain aspects of the ACA, as well as recent efforts by the Trump Administration to repeal or replace certain aspects of the ACA. On December 14, 2018, a Texas U.S. District Court Judge ruled that the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of the Tax Act. While the Texas U.S. District Court Judge, as well as the Trump administration and the Centers for Medicare & Medicaid Services (“CMS”), have stated that the ruling will have no immediate effect pending appeal of the decision, it is unclear how this decision, subsequent appeals, and other efforts to repeal and replace the ACA will impact the PPACA and our business.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. In August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. These changes include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect on April 1, 2013 and, as amended by subsequent legislation including the Bipartisan Budget Act of 2018, will stay in effect through 2027 unless additional Congressional action is taken. In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. Moreover, the Drug Supply Chain Security Act, enacted in 2013, imposes obligations on manufacturers of pharmaceutical products related to product tracking and tracing. These laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on our customers and accordingly, our financial operations.

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We anticipate that the ACA, as well as alternative or replacement healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and additional downward pressure on the reimbursement we may receive for any approved product. Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives.

In addition, levels of reimbursement may be impacted by other current and future legislation, regulation or reimbursement policies of third-party payors in a manner that may harm the demand and reimbursement available for our products, including for companion diagnostics for our products, which in turn, could harm our future product pricing and sales. Any reduction in reimbursement from Medicare and other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our products.

Competition in our targeted market area is intense and this field is characterized by rapid technological change. Therefore developments by competitors may substantially alter the predicted market or render our product candidates uncompetitive.

There are hundreds of drugs in clinical development today in the area of oncology therapeutics. We have competitors both in the United States and internationally, including major multinational pharmaceutical companies, biotechnology companies and universities and other research institutions. In the oncology market, our major competitors include, but are not limited to: Amgen, Inc., Corvus Pharmaceuticals, Inc., Eisai Co. Ltd., Exelixis, Inc., F. Hoffman-La Roche Ltd., Johnson & Johnson, Merck & Co. Inc., Nektar Therapeutics, and Novartis AG among others.

Many companies have filed, and continue to file, patent applications in oncology which may or could affect our programs. Some of these patent applications may have already been allowed or issued, and others may issue in the future. These companies include, but are not limited to: Amgen, Inc., Astellas Pharma Inc., AstraZeneca plc, Bristol-Myers Squibb Company, Exelixis, Inc., Novartis AG, Pfizer Inc. and Johnson & Johnson. Since this area is competitive and of strong interest to pharmaceutical and biotechnology companies, there will likely be additional patent applications filed, and additional patents granted, in the future, as well as additional research and development programs expected in the future.

In addition to companies that have kinase inhibitors addressing our oncology indications of interest, our competition also includes hundreds of private and publicly traded companies that operate in the area of oncology but have therapeutics with different mechanisms of action. The oncology market in general is highly competitive with over 1,000 molecules currently in clinical development.

Developments by others may render our products or technologies non-competitive or obsolete or we may not be able to keep pace with technological developments. Our competitors may have developed or may be developing technologies which may be the basis for competitive products. Some of these products may prove to be more effective and less costly than the products developed or being developed by us. Our competitors may obtain regulatory approval for their products more rapidly than we do which may change the standard of care in the indications we are targeting, rendering our technology or products non-competitive or obsolete. For example, with the recent approval of immunotherapy agents for the treatment of NSCLC and other cancers, the standard of care for the treatment of cancer is evolving and will continue to evolve which could require us to change the design and timelines for our registration trails and may limit the commercial acceptance of our products in the future. Others may develop treatments or cures superior to any therapy we are developing or will develop. Moreover, alternate, less toxic forms of medical treatment may be developed which may be competitive with our products.

Many of the organizations which could be considered to be our competitors have substantially more financial and technical resources, more extensive discovery research, preclinical research and development capabilities and greater manufacturing, marketing, distribution, production and human resources than we do. Many of our current or potential competitors have more experience than us in research, preclinical testing and clinical trials, drug commercialization, manufacturing and marketing, and in obtaining domestic and foreign regulatory approvals. In addition, failure, unacceptable toxicity, lack of sales or disappointing sales or other issues regarding competitors’ products or processes could have a material adverse effect on our product candidates, including our clinical candidates or our lead compounds. Established pharmaceutical companies may invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make our product candidates less competitive. In addition, any new product that competes with an approved product must demonstrate compelling advantages in efficacy, convenience, tolerability and safety in order to overcome price competition and brand recognition and to be commercially successful. Accordingly, our competitors may succeed in obtaining patent protection, receiving FDA, EMA or other regulatory approval or discovering, developing and commercializing medicines before we do, which would have a material adverse impact on our business.

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We will not be able to successfully commercialize our product candidates without establishing sales and marketing capabilities internally or through collaborators.

We currently have no sales and marketing staff. We may not be able to find suitable sales and marketing staff and collaborators for all of our product candidates. We have no prior experience in the marketing, sale and distribution of pharmaceutical products and there are significant risks involved in building and managing a sales organization, including our ability to hire, retain and incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, and effectively manage a geographically dispersed sales and marketing team. Any collaborators may not be adequate or successful or could terminate or materially reduce the effort they direct to our products. The development of a marketing and sales capability will require significant expenditures, management resources and time. The cost of establishing such a sales force may exceed any potential product revenue, or our marketing and sales efforts may be unsuccessful. If we are unable to develop an internal marketing and sales capability in a timely fashion, or at all, or if we are unable to enter into a marketing and sales arrangement with a third party on acceptable terms, we may be unable to successfully develop and seek regulatory approval for our product candidates and/or effectively market and sell approved products, if any.

We are subject to competition for our skilled personnel and may experience challenges in identifying and retaining key personnel that could impair our ability to conduct our operations effectively.

Our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy. Although we have not experienced problems attracting and retaining highly qualified personnel in the recent past, our industry has experienced a high rate of turnover of management personnel in recent years. Our ability to compete in the highly competitive biotechnology and pharmaceuticals industries depends upon our ability to attract and retain highly qualified managerial, scientific and medical personnel. We are highly dependent on our management, scientific and medical personnel, especially Charles M. Baum, M.D., Ph.D., our President and Chief Executive Officer, Isan Chen, M.D., our Executive Vice President and Chief Medical and Development Officer, James Christensen, Ph.D. our Executive Vice President and Chief Scientific Officer, Jamie A. Donadio, our Senior Vice President and Chief Financial Officer, and Chris LeMasters, our Executive Vice President and Chief Business Officer whose services are critical to the successful implementation of our product candidate acquisition, development and regulatory strategies, as well as the management of our financial operations. We are not aware of any present intention of any of these individuals to leave our Company. In order to induce valuable employees to continue their employment with us, we have provided stock options that vest over time. The value to employees of stock options that vest over time is significantly affected by movements in our stock price that are beyond our control, and may at any time be insufficient to counteract more lucrative offers from other companies.

Despite our efforts to retain valuable employees, members of our management, scientific and development teams may terminate their employment with us at any time, with or without notice. The loss of the services of any of our executive officers or other key employees and our inability to find suitable replacements could harm our business, financial condition and prospects. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior managers as well as junior, mid-level and senior scientific and medical personnel.

We may also experience growth in the number of our employees and the scope of our operations, especially in clinical development. This growth will place a significant strain on our management, operations and financial resources and we may have difficulty managing this future potential growth. No assurance can be provided that we will be able to attract new employees to assist in our growth. Many of the other pharmaceutical companies that we compete against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than we do. We also may employ consultants or part-time and contract employees. There can be no assurance that these individuals are retainable. While we have been able to attract and retain skilled and experienced personnel and consultants in the past, no assurance can be given that we will be able to do so in the future.

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Our current and future relationships with customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.

As a pharmaceutical company, even though we do not and will not control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party payors, certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business. Our current and future arrangements with third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act, which may constrain the business or financial arrangements and relationships through which we sell, market and distribute any drugs for which we obtain marketing approval. In addition, we may be subject to transparency laws and patient privacy regulation by U.S. federal and state governments and by governments in foreign jurisdictions in which we conduct our business. The laws that may affect our ability to operate include:

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the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order, lease, furnishing, prescribing or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs, such as Medicare and Medicaid. The term “remuneration” has been broadly interpreted to include anything of value. The ACA, among other things, amended the intent requirement of the federal Anti‑Kickback Statute such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate, in order to commit a violation;

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federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act which can be enforced by private individuals on behalf of the government through civil whistleblower or qui tam actions, prohibits individuals or entities for knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. Entities can be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers, promoting a product off‑label, or for providing medically unnecessary services or items. In addition, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act;

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the federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), which imposes criminal and civil liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with the delivery of or payment for healthcare benefits, items or services;

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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 ("HITECH"), and their respective implementing regulations, which impose obligations on certain healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, as well as individuals and entities that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, known as business associates, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in U.S. federal courts to enforce the federal HIPAA laws and seek attorneys' fees and costs associated with pursuing federal civil actions;

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the federal Open Payments program, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information related to “payments or other transfers of value” made to physicians, which is defined to include doctors, dentists, optometrists, podiatrists and chiropractors, and teaching hospitals and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by physicians and their immediate family members, and contains requirements for manufacturers to submit reports to CMS by the 90th day of each calendar year, and disclosure of such information to be made by CMS on a publicly available website; and

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analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures, or drug pricing; state and local laws that require the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Because of the breadth of these laws and the narrowness of available statutory exceptions and regulatory safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of such laws. To the extent that any of our product candidates is ultimately sold in countries other than the United States, we may be subject to similar laws and regulations in those countries. If we or our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil, criminal and administrative penalties, damages, fines, imprisonment, disgorgement, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, exclusion from participation in government healthcare programs, and the curtailment or restructuring of our operations, any of which could have a material adverse effect on our business. If any of the physicians or other healthcare providers or entities with whom we expect to do business, including any of our collaborators, is found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusion from participation in government healthcare programs, which could also materially affect our business.

We may become subject to the risk of product liability claims.

We face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater risk if we commercialize any products. Human therapeutic products involve the risk of product liability claims and associated adverse publicity. Currently, the principal risks we face relate to patients in our clinical trials, who may suffer unintended consequences. Claims might be made by patients, healthcare providers, pharmaceutical companies or others. For example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability and a breach of warranties. Claims could also be asserted under state consumer protection laws. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates, if approved. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:


•	decreased demand for our product candidates;


•	injury to our reputation;


•	withdrawal of clinical trial participants;


•	initiation of investigations by regulators;


•	costs to defend the related litigation;


•	a diversion of management’s time and our resources;


•	substantial monetary awards to trial participants or patients;


•	product recalls, withdrawals or labeling, marketing or promotional restrictions;


•	loss of revenue from product sales; and


•	the inability to commercialize any of our product candidates, if approved.

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We may not have or be able to obtain or maintain sufficient and affordable insurance coverage, and without sufficient coverage any claim brought against us could have a materially adverse effect on our business, financial condition or results of operations. We run clinical trials through investigators that could be negligent through no fault of our own and which could affect patients, cause potential liability claims against us and result in delayed or stopped clinical trials. We are required in many cases by contractual obligations to indemnify collaborators, partners, third-party contractors, clinical investigators and institutions. These indemnifications could result in a material impact due to product liability claims against us and/or these groups. We currently carry $10 million in product liability insurance, which we believe is appropriate for our clinical trials. Although we maintain such insurance, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.

Our business involves the controlled use of hazardous materials and as such we are subject to environmental and occupational safety laws. Continued compliance with these laws may incur substantial costs and failure to maintain compliance could result in liability for damages that may exceed our resources.

Our preclinical research, manufacturing and development processes involve the controlled use of hazardous and radioactive materials. We are subject to federal, local and foreign laws and regulations governing the use, manufacture, storage, handling and disposal of such materials and certain waste products. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also produce hazardous waste products. The risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident, we could be held liable for any damages that result, and any such liability could exceed our resources. We may not be adequately insured against this type of liability. We may be required to incur significant costs to comply with environmental laws and regulations in the future, and our operations, business or assets may be materially adversely affected by current or future environmental laws or regulations.

We may have to dedicate resources to the settlement of litigation.

Securities legislation in the United States, Canada and other countries makes it relatively easy for stockholders to sue. This could lead to frivolous lawsuits which could take substantial time, money, resources and attention or force us to settle such claims rather than seek adequate judicial remedy or dismissal of such claims.

If we are required to defend patent infringement actions brought by third parties, or if we sue to protect our own patent rights or otherwise to protect our proprietary information and to prevent its disclosure, or if we are involved in other litigation, whether as a plaintiff or defendant, we may be required to pay substantial litigation costs and managerial attention may be diverted from business operations even if the outcome is in our favor. If we are required to defend our patents or trademarks against infringement by third parties, we may be required to pay substantial litigation costs and managerial attention and financial resources may be diverted from our research and development operations even if the outcome is in our favor.

We may be vulnerable to disruption, damage and financial obligation as a result of system failures.

Despite the implementation of security measures, any of the internal computer systems belonging to us, our collaborators or our third-party service providers are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failure. Any system failure, accident or security breach that causes interruptions in our own, in collaborators’ or in third-party service vendors’ operations could result in a material disruption of our drug discovery and development programs. In addition, we rely upon third-party contractors and service providers for the hosting, support and/or maintenance of some aspects of our computer hardware, computer software and telecommunications systems. Failure of those contractors and service providers to provide systems and services of a suitable quality and within acceptable timeframes may cause the delay or failure of our development programs, or loss of confidential or proprietary information. To the extent that any disruption or security breach results in a loss or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we may incur liability, our drug discovery and development programs may be adversely affected and the further development of our product candidates may be delayed. Furthermore, we may incur additional costs to remedy the damages caused by these disruptions or security breaches.

Changes in funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.

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The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including most recently beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Risks Relating to Our Intellectual Property

* We may not obtain adequate protection for our product candidates through patents and other intellectual property rights and as such our competitive advantage in the marketplace may be compromised.

Our success depends, in part, on our ability to secure and protect our patents, trade secrets, trademarks and other intellectual property rights and to operate without infringing on the proprietary rights of others or having third parties circumvent the rights that we own or license. We have filed and are actively pursuing patent applications in the United States, Japan, Europe and other major markets via the Patent Cooperation Treaty or directly in countries of interest. The patent positions of healthcare companies, universities and biopharmaceutical companies, including ours, are uncertain and involve complex questions of law and fact for which important legal issues may remain unresolved. Therefore, there is no assurance that our pending patent applications will result in the issuance of patents or that we will develop additional proprietary products which are patentable. Moreover, patents issued or to be issued to us may not provide us with any competitive advantage. Further, if the patent applications we hold or in-license with respect to our programs, product candidates and companion diagnostic fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for our product candidates, it could dissuade companies from collaborating with us to develop product candidates, and threaten our ability to commercialize future products.

Our patents may be challenged by third parties at the United States Patent and Trademark Office ("USPTO"), comparable foreign patent offices, or in patent litigation. In addition, it is possible that third parties with products that are very similar to ours will circumvent our patents by means of alternate designs or processes or file applications or be granted patents that would block or hurt our efforts.

There are no assurances that our patent counsel, lawyers or advisors have given us correct advice or counsel. Opinions from such patent counsel or lawyers may not be correct or may be based on incomplete facts. We cannot be certain that we are the first to invent or first to file for patent protection for the inventions covered by pending patent applications and, if we are not, we may be subject to priority disputes. We may be required to disclaim part or all of the subject matter and/or term of certain patents or all of the subject matter and/or term of certain patent applications. There may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim. There also may be prior art of which we are aware, but which we do not believe affects the validity or enforceability of one or more claims, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim. No assurance can be given that if challenged, our patents would be declared by the USPTO, comparable foreign patent offices or a court to be valid or enforceable or that even if found valid and enforceable, a competitor’s technology or product would be found by a court to infringe our patents. The possibility exists that others will develop products which have the same effect as our products on an independent basis which do not infringe our patents or other intellectual property rights, or will design around the claims of patents that we have had issued that cover our products. The steps we have taken to protect our intellectual property may not prevent the misappropriation of our proprietary information and technologies, particularly in foreign countries where laws or law enforcement practices may not protect proprietary rights to the same extent as in the United States, Europe or Japan. Unauthorized disclosure of our proprietary information could also harm our competitive position. We could also inadvertently use our collaborators’ data inappropriately which could lead to liability. We may file patent applications but have the scope of the claims narrowed or significantly narrowed during prosecution or we may not be able to supply sufficient data to satisfy a patent office to support the full breadth of our claims and, as a result, may not obtain the original claims desired or we may receive amended claims with significantly reduced scope. Alternatively, it is possible that we may not receive any patent protection from an application.

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Maintaining our patents and applications requires timely payment of fees and other associated costs in the countries of filing, and we could inadvertently abandon a patent or patent application (or trademark or trademark application) due to non-payment of fees, or as a result of a failure to comply with filing deadlines or other requirements of the prosecution process, resulting in the loss of protection of certain intellectual property rights in a certain country. Alternatively, we, our collaborators or our patent counsel may take action resulting in a patent or patent application becoming abandoned which may not be able to be reinstated, or if reinstated, may suffer patent term adjustments. Any of these outcomes could hurt our ability to gain full patent protection for our products. Registered trademarks and/or applications for trademark registrations in the United States that belong to us are subject to similar risks as described above for patents and patent applications.

Many of our collaboration agreements are complex and may call for licensing or cross-licensing of potentially blocking patents, know-how or intellectual property. Due to the potential overlap of data, know-how and intellectual property rights there can be no assurance that one of our collaborators will not dispute our right to send data or know-how or other intellectual property rights to third parties and this may potentially lead to liability or termination of a program or litigation. There are no assurances that the actions of our collaborators would not lead to disputes or cause us to default with other collaborators. We cannot be certain that a collaborator will not challenge the validity of licensed patents.

We cannot be certain that any country’s patent and/or trademark office will not implement new rules which could affect how we draft, file, prosecute and/or maintain patents and patent applications, or that certain patent rights and/or trademark rights will be granted by governmental authorities in particular foreign countries. We cannot be certain that increasing costs for drafting, filing, prosecuting and maintaining patent applications and patents will not limit our ability to file for patent protection, or to prosecute applications through to grant. We may be forced to abandon or return the rights to specific patents due to a lack of financial resources. There is no assurance that we could enter into licensing arrangements at a reasonable cost, or develop or obtain alternative technology in respect of patents issued to third parties that incidentally cover our products. Any inability to secure such licenses or alternative technology could result in delays in the introduction of some of our products or even lead to prohibition of the development, manufacture or sale of certain products by us.

We may file applications for trademark registrations in connection with our product candidates in various jurisdictions, including the United States. No assurance can be given that any of our trademark applications will be registered in the United States or elsewhere, or that the use of any registered or unregistered trademarks will confer a competitive advantage in the marketplace. Furthermore, even if we are successful in our trademark registrations, the FDA and regulatory authorities in other countries have their own process for drug nomenclature and their own views concerning appropriate proprietary names. No assurance can be given that the FDA or any other comparable regulatory authority will accept any of our trademarks or will not request reconsideration of one of our trademarks, for use in connection with our drug product candidates, whether currently or at some time in the future. The loss, abandonment, or cancellation of any of our trademarks or trademark applications could negatively affect the success of the product candidates to which they relate.

Moreover, some of our know-how and technology which is not patented or not patentable may constitute trade secrets. Therefore, we require our consultants, advisors and collaborators to enter into confidentiality agreements and our employees to enter into invention and non-disclosure agreements. However, no assurance can be given that such agreements will provide for a meaningful protection of our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure of information. Furthermore, we cannot provide assurance that any of our employees, consultants, contract personnel or collaborators, either accidentally or through willful misconduct, will not cause serious negative impact to our programs and/or our strategy. All of our employees have signed confidentiality agreements, but there can be no assurance that they will not inadvertently or through their misconduct give trade secrets away.

Third-party patents or intellectual property infringement claims may result in a reduction in the scope of our patent protection and competitive exclusivity with respect to our product candidates. Patent litigation, including defense against third-party intellectual property claims, may result in us incurring substantial costs.

Patent applications which may relate to or affect our business may have been filed by others. Such patent applications or patents resulting there from may conflict with our technologies, patents or patent applications, potentially reducing the scope or strength of our patent protection, and may ultimately be determined to limit or prohibit our freedom to operate with respect to our product candidates. Such events could cause us to stop or change the course of our research and development or modify our intellectual property strategies. We could also become involved in interference proceedings in connection with one or more of our patents or patent applications to determine priority of invention, or in post-grant opposition proceedings at the USPTO or comparable foreign patent offices. There can be no guarantees that an interference proceeding or defense of a post-grant opposition would be successful or that such an outcome would be upheld on appeal. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does

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not offer us a license on commercially reasonable terms. Our defense of such interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees.

No assurance can be given that our patents, once issued, would be declared by a court to be valid or enforceable, or that we would not be found to infringe a competitor’s patent.

Third parties may assert that we are using their proprietary information without authorization. Third parties may also have or obtain patents and may claim that technologies licensed to or used by us infringe their patents. Because patent applications can take many years to issue, third parties may have currently pending patent applications which may later result in issued patents that our product candidates or companion diagnostic may infringe, or which such third parties claim are infringed by the use of our technologies. If any third-party patents are held by a court of competent jurisdiction to cover any aspect of our product candidates, including the formulation or method of use of such product candidate, the holders of any such patents may be able to block our ability to commercialize such product candidate unless we obtain a license under the applicable patents, or until such patents expire. In any such case, such a license may not be available on commercially reasonable terms or at all. We may attempt to invalidate a competitor’s patent or trademark. There is no assurance such action will ultimately be successful and, even if initially successful, it could be overturned upon appeal. In addition, any legal action that seeks damages or an injunction to stop us from carrying on our commercial activities relating to the affected technologies could subject us to monetary liability. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources.

Parties making claims against us for alleged infringement of their intellectual property rights may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we could be required to redesign our infringing products or obtain a license from such third party to continue developing and commercializing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms, or at all. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. It may be impossible to redesign our products and technology, or it may require substantial time and expense, which could force us to cease commercialization of one or more of our product candidates, or some of our business operations, which could materially harm our business. In addition, in any such proceeding, we may be required to pay substantial damages, including treble damages and attorneys’ fees in the event we are found liable for willful infringement.

Our intellectual property may be infringed upon by a third party.

Third parties may infringe one or more of our issued patents or trademarks. We cannot predict if, when or where a third party may infringe one or more of our issued patents or trademarks. There is no assurance that we would be successful in a court of law to prove that a third party is infringing one or more of our issued patents. Even if we are successful in proving in a court of law that a third party is infringing one or more of our issued patents there can be no assurance that we would be successful in halting their infringing activities, for example, through a permanent injunction, or that we would be fully or even partially financially compensated for any harm to our business. We may be forced to enter into a license or other agreement with the infringing third party at terms less profitable or otherwise less commercially acceptable to us than if the license or agreement were negotiated under conditions between those of a willing licensee and a willing licensor. We may not become aware of a third party infringer within legal timeframes that would enable us to seek adequate compensation, or at all, thereby possibly losing the ability to be compensated for any harm to our business. Such a third-party may be operating in a foreign country where the infringer is difficult to locate, where we do not have issued patents and/or the patent laws may be more difficult to enforce. Some third-party infringers may be able to sustain the costs of complex patent infringement litigation more effectively than we can because they have substantially greater resources. Any inability to stop third-party infringement could result in loss in market share of some of our products or even lead to a delay, reduction and/or inhibition of the development, manufacture or sale of certain products by us. There is no assurance that a product produced and sold by a third-party infringer would meet our or other regulatory standards or would be safe for use. Such third-party infringer products could irreparably harm the reputation of our products thereby resulting in substantial loss in market share and profits.

Third parties may seek to obtain approval of a generic version of approved products. Defense against entry of a generic product may result in us incurring substantial costs and ultimate failure to prevail against approval of a generic product could result in a substantial loss of market share and profits.

Even if we are successful in obtaining regulatory approval to sell any of our product candidates in one or more countries, we cannot be certain that our patents and other intellectual property rights will ultimately prevent approval during the patent term

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of generic products developed and commercialized by third parties. A generic manufacturer may seek approval of a generic version of any of our products in the United States by filing an Abbreviated New Drug Application ("ANDA"), with the FDA asserting that our patents are invalid and/or unenforceable to maintain market exclusivity for any of our products, if approved. We cannot predict if, or when, one or more generic manufacturers may attempt to seek regulatory approval for a generic version of any of our products, if approved. There is no assurance that we will ultimately be successful in a court of law to prevent entry of a generic version of any of our products during the applicable patent term and we may incur substantial costs defending our patents and intellectual property rights. An inability to stop a generic manufacturer from selling a generic version of our products could result in a substantial loss of market share and profits or even preclude the ability to continue to commercialize any of our products, if approved.

Risks Related to Our Shares of Common Stock

Our share price is volatile and may be influenced by numerous factors that are beyond our control.

A low share price and low market valuation may make it difficult to raise sufficient additional cash due to the significant dilution to current stockholders. Market prices for shares of biotechnology and biopharmaceutical companies such as ours are often volatile. Factors such as clinical and regulatory developments regarding our products or processes, developments regarding potential or future third-party collaborators, announcements of technological innovations, new commercial products, patents, the development of proprietary rights by us or by others or any litigation relating to these rights, regulatory actions, general conditions in the biotechnology and pharmaceutical industries, failure to meet analysts’ expectations, publications, financial results or public concern over the safety of biopharmaceutical and biotechnological products, economic conditions in the United States and other countries, terrorism and other factors could have a significant effect on the share price for our shares of common stock. Any setback or delay in the clinical development of our programs could result in a significant decrease in our share price. In recent years the stock of other biotechnology and biopharmaceutical companies has experienced extreme price fluctuations that have been unrelated to the operating performance of the affected companies. There can be no assurance that the market price of our shares of common stock will not experience significant fluctuations in the future, including fluctuations that are unrelated to our performance. These fluctuations may result due to macroeconomic and world events, national or local events, general perception of the biotechnology industry or to a lack of liquidity. In addition, other biotechnology companies' or our competitors’ programs could have positive or negative results that impact their stock prices and their results or experience stock price fluctuations that could have a positive or negative impact on our stock price, regardless whether such impact is direct or not.

Stockholders may not agree with our business, scientific, clinical and financial strategy, including additional dilutive financings, and may decide to sell their shares or vote against such proposals. Such actions could materially impact our stock price. In addition, portfolio managers of funds or large investors can change or change their view on us and decide to sell our shares. These actions could have a material impact on our stock price. In order to complete a financing, or for other business reasons, we may elect to consolidate our shares of common stock. Investors may not agree with these actions and may sell our shares. We may have little or no ability to impact or alter such decisions.

* Our principal stockholders control the majority of our shares, and their actions may significantly influence matters submitted to our stockholders for approval and our share price.

Based on the information available to us as of March 31, 2019 , our stockholders and their affiliates who owned more than 5% of our outstanding common stock collectively owned 52% of our outstanding common stock. Baker Bros. Advisors, LLC ("Baker Brothers") and Boxer Capital, LLC ("Boxer Capital") and their affiliates collectively own 23% of our outstanding common stock. In addition, in conjunction with certain financing transactions, we granted to Baker Brothers and Boxer Capital each the right to nominate a member of our Board of Directors and the right to appoint an observer on our Board of Directors. Collectively Baker Brothers and Boxer Capital may have significant influence over matters submitted to our stockholders for approval, including the election and removal of directors and the approval of any merger, consolidation, or sale of all or substantially all of our assets. Furthermore, as a thinly traded stock, if Baker Brothers, Boxer Capital or any other of our major stockholders determine to exit from the industry or from their holdings in us, for whatever reason, the impact on our share price could be detrimental over a prolonged period of time.

Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.

We expect that significant additional capital will be needed in the future to continue our planned operations. To the extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. We may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from

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time to time. If we sell common stock, convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales. These sales may also result in material dilution to our existing stockholders, and new investors could gain rights superior to our existing stockholders.

Pursuant to our 2013 Equity Incentive Plan ("the 2013 Plan"), and our 2013 Employee Stock Purchase Plan ("the ESPP"), our management is authorized to grant stock options and other equity-based awards to our employees, directors and consultants, and to sell our common stock to our employees, respectively. Any increase in the number of shares outstanding as a result of the exercise of outstanding options, the vesting or settlement of outstanding stock awards, or the purchase of shares pursuant to the ESPP will cause our stockholders to experience additional dilution, which could cause our stock price to fall.

Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, would be our stockholders’ only source of gain.

We have never declared or paid any cash dividends on our common shares, and we currently expect that earnings, if any, and cash flow will primarily be retained and used in our operations, including servicing any debt obligations we may have now or in the future. Accordingly, although we do not anticipate paying any dividends in the foreseeable future, we may not be able to generate sufficient cash flow in order to allow us to pay future dividends on, or make any distributions with respect to our common stock. As a result, capital appreciation, if any, of our common stock would be our stockholders’ sole source of gain on their investment in our common stock for the foreseeable future.


ITEM 2.	Unregistered Sales of Equity Securities and Use of Proceeds

None.


ITEM 3.	Defaults Upon Senior Securities

None.


ITEM 4.	Mine Safety Disclosures

Not applicable.

ITEM 5. Other Information

None.

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ITEM 6.	Exhibits



Exhibit number		Description of document
2.1		Arrangement Agreement, dated May 8, 2013, by and between MethylGene Inc. and the Company . ⁽²⁾
3.1		Amended and Restated Certificate of Incorporation . ⁽¹⁾
3.2		Bylaws. ⁽¹⁾
3.3		Amendment to Bylaws. ⁽³⁾
4.1		Form of Common Stock Certificate. ⁽²⁾
4.2		Form of Warrant to Purchase Common Stock ⁽⁴⁾
4.3		Form of Warrant to Purchase Common Stock ⁽⁵⁾
4.4		Form of Warrant to Purchase Common Stock ⁽⁶⁾
5.1		Opinion of Cooley LLP.
10.1*		Clinical Trial Collaboration and Supply Agreement, dated January 3, 2019, by and between Mirati Therapeutics, Inc. and Bristol-Myers Squibb Company, and related Supply/Quality Addendum dated March 29, 2019.
10.2*		Drug Discovery Collaboration Option Agreement, dated October 1, 2014, by and between Mirati Therapeutics, Inc. and Array BioPharma Inc., and related amendments dated August 13, 2015, November 9, 2015, February 13, 2016, and August 24, 2018.
23.1		Consent of Cooley LLP (included in Exhibit 5.1)
31.1		Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
31.2		Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
32.1		Certifications Pursuant to U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Public Company Accounting Reform and Investor Protection Act of 2002.
101.INS		XBRL Instance Document.
101.SCH		XBRL Taxonomy Extension Schema Document.
101.CAL		XBRL Taxonomy Extension Schema Document.
101.DEF		XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB		XBRL Taxonomy Extension Label Linkbase Document.
101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document.

_____________________________________________________


*	Certain portions of this exhibit (indicated by "[***]") have been omitted as Mirati Therapeutics, Inc. has determined (i) the omitted information is not material and (ii) the omitted information would likely cause harm to Mirati Therapeutics, Inc. if publicly disclosed.


⁽¹⁾	Incorporated by reference to Mirati Therapeutics, Inc.'s Registration Statement on Form 10-12B (No. 001-35921), filed with the Securities and Exchange Commission on May 10, 2013.


⁽²⁾	Incorporated by reference to Mirati Therapeutics, Inc.’s Amended Registration Statement on Form 10-12B/A (No. 001-35921), filed with the Securities and Exchange Commission on June 14, 2013.


⁽³⁾	Incorporated by reference to Mirati Therapeutics, Inc.'s Current Report on Form 8-K, filed with the Securities and Exchange Commission on June 16, 2016.

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⁽⁴⁾	Incorporated by reference to Mirati Therapeutics, Inc.'s Current Report on Form 8-K, filed with the Securities and Exchange Commission on January 6, 2017.


⁽⁵⁾	Incorporated by reference to Mirati Therapeutics, Inc.'s Current Report on Form 8-K, filed with the Securities and Exchange Commission on November 16, 2017.


⁽⁶⁾	Incorporated by reference to Mirati Therapeutics, Inc.'s Current Report on Form 8-K, filed with the Securities and Exchange Commission on June 7, 2018.

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 hereunto duly authorized.



		MIRATI THERAPEUTICS, INC.

Date: April 29, 2019	by:	/s/ Charles M. Baum
		Chief Executive Officer
		(Principal Executive Officer)

Date: April 29, 2019	by:	/s/ Jamie A. Donadio
		Senior Vice President and Chief Financial Officer
		(Principal Financial and Accounting Officer)

Exhibit 5.1



Sean M. Clayton
+1 858 550 6034
sclayton@cooley.com

April 29, 2019

Mirati Therapeutics, Inc.

9393 Towne Centre Drive, Suite 200

San Diego, CA 92121

Ladies and Gentlemen:

You have requested our opinion, as counsel to Mirati Therapeutics, Inc., a Delaware corporation (the “ Company ”), with respect to certain matters in connection with the sale by the Company of up to an aggregate of 10,417,887 shares (the “ Shares ”) of the Company’s common stock, par value $0.001 (“ Common Stock ”), issuable upon the exercise of certain pre-funded warrants to purchase Common Stock (the “ Warrants ”). The Shares are issuable upon the exercise of the Warrants, pursuant to the Registration Statement on Form S-3 (the “ Registration Statement ”), filed with the Securities and Exchange Commission (the “ Commission ”) under the Securities Act of 1933, as amended (the “ Act ” ), the prospectus included within the Registration Statement (the “ Base Prospectus ”), and the prospectus supplement relating to the Shares dated April 29, 2019 filed with the Commission pursuant to Rule 424(b) of the Rules and Regulations of the Act ( together with the Base Prospectus, the “ Prospectus ”). All of the Shares are to be sold by the Company as described in the Prospectus.

In connection with this opinion, we have examined and relied upon the Registration Statement and the Prospectus, the Warrants, the Company’s certificate of incorporation and bylaws, each as currently in effect, and originals or copies certified to our satisfaction of such records, documents, certificates, memoranda and other instruments as in our judgment are necessary or appropriate to enable us to render the opinion expressed below. As to certain factual matters, we have relied upon a certificate of an officer of the Company and have not independently verified such matters. In rendering this opinion, we have assumed the genuineness and authenticity of all signatures on signed documents; the authenticity of all documents submitted to us as originals; the conformity to originals of all documents submitted to us as copies; the accuracy, completeness and authenticity of certificates of public officials; and the due authorization, execution and delivery of all documents where due authorization, execution and delivery are a prerequisite to the effectiveness thereof (except we have not made such assumption with respect to the Company).

Our opinion is expressed with respect to the General Corporation Law of the State of Delaware. We express no opinion to the extent that any other laws are applicable to the subject matter hereof and express no opinion and provide no assurance as to compliance with any federal or state securities law, rule or regulation.

We express no opinion to the extent that, notwithstanding its current reservation of shares of Common Stock, future issuances of securities of the Company and/or adjustments to outstanding securities, including the Warrants, of the Company may cause the Warrants to be exercisable for more shares of Common Stock than the number that remains authorized but

4401 Eastgate Mall, San Diego, CA 92121 T: (858) 550-6000 F: (858) 550-6420 www.cooley.com




Mirati Therapeutics, Inc. April 29, 2019 Page Two

unissued. Further, we have assumed the Exercise Price (as defined in the Warrants) will not be adjusted to an amount below the par value per share of the Common Stock.

On the basis of the foregoing, and in reliance thereon, we are of the opinion that the Shares, when issued and sold in accordance with the terms of the Warrants, will be validly issued, fully paid and nonassessable.

We consent to the reference to our firm under the caption “Legal Matters” in the Prospectus and to the filing of this opinion as an exhibit to a Quarterly Report on Form 10-Q to be filed with the Commission for incorporation by reference into the Registration Statement.

Very truly yours,

Cooley LLP

By: /s/ Sean M. Clayton

Sean M. Clayton

4401 Eastgate Mall, San Diego, CA 92121 T: (858) 550-6000 F: (858) 550-6420 www.cooley.com

Exhibit 10.1

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT MARKED BY [***], HAS BEEN OMITTED BECAUSE MIRATI THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO MIRATI THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

Execution Version

CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT

This CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT (the “ Agreement ”) is made and entered into effective as of January 3, 2019 (the “ Effective Date ”) by and between Mirati Therapeutics, Inc., having a place of business at 9393 Towne Centre Drive Suite 200, San Diego CA 92121 (the “ Recipient ”), and Bristol-Myers Squibb Company , having a place of business at Route 206 and Province Line Road, Princeton, New Jersey, USA 08543 (“ BMS ”). The Recipient and BMS are sometimes individually referred to in this Agreement as a “ Party ” and collectively as the “ Parties .”

PRELIMINARY STATEMENTS


A .	The Recipient desires to conduct, and BMS desires to supply the BMS Study Drug (as defined below) for the conduct of, a Combined Therapy Clinical Trial (as defined below) in accordance with the Protocol (as defined below) therefor and in accordance with the terms of this Agreement.


B.	The Parties desire to agree on various terms and conditions to govern the Parties’ respective rights and obligations in connection with the performance of the Combined Therapy Clinical Trial and the ownership and use of the results of such trial.

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

ARTICLE 1

DEFINITIONS

The following terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the meaning set forth below. If not listed below, terms with initial letters capitalized and defined elsewhere in places throughout this Agreement shall have the meanings designated in such definitions.

“ Adverse Event ,” (“AE”) “ Serious Adverse Event ” (“SAE”) and “ Serious Adverse Drug Reaction ” (“SADR”) shall have the meanings provided to such terms in the International Conference on Harmonization (“ICH”) guideline for industry on Clinical Safety Data Management (E2A, Definitions and Standards for Expedited Reporting).

“ Affiliate ” means, with respect to a particular Party, an entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with such Party. As used in this definition, the term “controls” (with correlative meanings for the terms “controlled by” or “under common control with”) means: (a) that the applicable entity owns, directly or indirectly, more than fifty percent (50%) of the voting stock of the applicable Party, or (b) that the applicable entity otherwise has the actual ability to control and direct the management of the applicable Party, whether by contract or otherwise.

“ Agreement ” means this Agreement, and includes the Appendices attached hereto, the Supply and Quality Documentation and any and all written amendments of any of the foregoing hereafter executed by the Parties with reference to this Agreement and made part hereof.

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“ Applicable Law ” means all applicable laws, rules and regulations (whether federal, state or local) that may be in effect from time to time, including current Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

“ Arbitration Matter ” means any disputed matter or issue between the Parties that relates to or arises out of the validity, interpretation or construction of, or the compliance with or breach of, this Agreement; provided that such disputed matter or issue has been referred to, but not resolved by, the Executive Officers as set forth in Section 13.3. For clarity, no Publication Dispute, or any matter requiring (by the terms of this Agreement) mutual agreement of both Parties shall be an Arbitration Matter.

“BeiGene-Recipient Agreements” means that certain Collaboration and License Agreement between BeiGene, Ltd, MethylGene Inc., and Recipient dated as of January 7, 2018, as amended from time to time, and agreements between BeiGene and Recipient and/or MethylGene Inc, and their Affiliates relating thereto that may be in effect from time to time.

“BeiGene Territory” means the countries listed in Appendix A of this Agreement.

“ BMS Class Drug ” means (i) the BMS Study Drug, and (ii) any other antibody that is designed to and does selectively bind to PD-1 or PD-L1.

“ BMS Indemnitees ” shall have the meaning set forth in Section 11.2.

“ BMS Independent Patent Right ” means a Patent Right that: (a) is Controlled by BMS (or any of its Affiliates) (i) as of the Effective Date, or (ii) during the Term that claims an invention that was conceived or first reduced to practice through activities other than those performed pursuant to this Agreement, and (b) Covers the use (whether alone or in combination with other agents), manufacture, formulation or composition of matter of the BMS Study Drug.

“ BMS Regulatory Documentation ” means any Regulatory Documentation of BMS (or its Affiliate) pertaining to the BMS Study Drug that exists as of the Effective Date or that is created during the Term through efforts outside this Agreement.

“ BMS Study Data ” shall have the meaning set forth in Section 8.1.

“ BMS Study Drug ” means BMS’ proprietary anti-PD-1 monoclonal antibody product known as Opdivo ^® (nivolumab).

“ BMS Study Invention ” means any Study Invention that pertains to: (a) the composition of matter of the BMS Study Drug (and not the Recipient Study Drug), (b) a method of manufacture or formulation or administration, including dosing, of the BMS Study Drug (and not the Recipient Study Drug) as a Single Agent Compound (and for clarity, not with respect to the Combined Therapy), and/or (c) a method of use of the BMS Study Drug (and not the Recipient Study Drug) as a monotherapy or as used with other agents, antibodies or compounds (other than a Study Invention pertaining to use with the Recipient Study Drug).

“ BMS Study Patent Right ” means any Patent Right that Covers a BMS Study Invention (and not a Recipient Study Invention or Combined Therapy Invention), excluding BMS Independent Patent Rights and BMS Technology. For avoidance of doubt, any Patent Rights that Cover both (a) a BMS Study Invention and (b) any other type of Study Invention is included within the Combined Therapy Patent Rights and is not within the BMS Study Patent Rights.

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“ BMS Technology ” means all Technology that is (a) Controlled by BMS (or its Affiliates) (i) as of the Effective Date, or (ii) during the Term and created through efforts outside of this Agreement, (b) related to the BMS Study Drug or the Combined Therapy, and (c) reasonably needed for the conduct of the Combined Therapy Clinical Trial and/or for Recipient to exercise the rights that are granted to Recipient under this Agreement. For clarity, all Study Inventions, Study Data, and Combined Therapy Clinical Trial Regulatory Documentation are excluded from the term BMS Technology.

“ Breaching Party ” shall have the meaning set forth in Section 12.2(a).

“ Business Day ” means a day other than Saturday, Sunday or a Federal holiday on which commercial banks located in New York, NY are authorized or obligated by U.S. federal law to be closed.

“ CDA ” shall have the meaning set forth in Section 9.1(a).

“ Clinical Hold ” means that (a) the FDA has issued an order to a Party pursuant to 21 CFR §312.42 to delay a proposed clinical investigation or to suspend an ongoing clinical investigation of the Combined Therapy or such Party’s Single Agent Compound in the United States or (b) a Regulatory Authority other than the FDA has issued an equivalent order to that set forth in (a) in any other country or group of countries.

“ Combined Therapy ” means a therapy using the Recipient Study Drug and the BMS Study Drug in combination.

“ Combined Therapy Clinical Trial ” means the human clinical trial using the Recipient Study Drug and the BMS Study Drug, which will be conducted by Recipient pursuant to this Agreement and the Protocol.

“ Combined Therapy IND ” shall have the meaning set forth in Section 2.1(b).

“ Combined Therapy Invention ” means any Invention that is not a Recipient Study Invention or a BMS Study Invention.

“ Combined Therapy Patent Right ” means any Patent Right that Covers a Combined Therapy Invention or Combined Therapy Study Data. For clarity, the BMS Independent Patent Rights and Recipient Independent Patent Rights are excluded from the term Combined Therapy Right.

“ Combined Therapy Clinical Trial Regulatory Documentation ” means any Regulatory Documentation submitted by or on behalf of Recipient for the conduct of the Combined Therapy Clinical Trial, but excluding (a) any Recipient Regulatory Documentation and (b) any BMS Regulatory Documentation.

“ Combined Therapy Study Data ” shall have the meaning set forth in Section 8.2.

“ Commercially Reasonable Efforts ” means, with respect to a Party, the level of effort and resources normally devoted by such Party to conduct or support the conduct (including manufacturing and supply of clinical materials) of a clinical trial for a biopharmaceutical product or compound that is owned by it or to which it has rights, which is of similar market potential, profit potential and strategic value and at a similar stage in its development or product life, based on conditions then prevailing.

“ Confidential Information ” shall have the meaning set forth in Section 9.1(a).

“ Control ” or “ Controlled ” means, with respect to particular Technology or intellectual property, that the applicable Party owns or has a license to such Technology or intellectual property ( other than solely by a license granted to such Party by the other Party under this Agreement) and has the ability to grant a

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right, license or sublicense to the other Party as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.

“ Cover ” means, with respect to a particular Patent Right and a particular Technology, that the practice by an unauthorized Person of such Technology (including, but not limited to, the manufacture, use or sale of such Technology) would infringe a claim included in such Patent Right, or in the case of a Patent Right that is a patent application (i.e., that has not issued as a patent), would infringe a claim in such patent application if it were to issue as a patent. “ Covered ” or “ Covering ” shall have correlative meanings.

“ CRO ” means any Third Party contract research organization used to conduct or assist in the conduct of the Combined Therapy Clinical Trial, including laboratories and Third Parties used to maintain the safety database from the Combined Therapy Clinical Trial, but, for clarity, excluding the Trial Sites.

“ Cure Period ” shall have the meaning set forth in Section 12.2(a).

“ [***] ” means [***].

“[***] Assay ” means the [***] assay.

“ Date of First Receipt ” means, with respect to a Party, the date on which any employee of such Party, its Affiliates or its Third Party subcontractors first becomes aware of applicable safety-related information.

“ Designated Clinical Contact ” shall have the meaning set forth in Section 2.3.

“ Designated Supply Contact ” shall have the meaning set forth in Section 4.7.

“ Dispute ” shall have the meaning set forth in Section 13.3(b).

“ Effective Date ” shall have the meaning set forth in the preamble to this Agreement.

“ Executive Officers ” means the Chief Business Officer of the Recipient and the Head of Oncology Development of BMS (or their respective designees).

“ FDA ” means the United States Food and Drug Administration, or any successor agency having the same or similar authority.

“ Final Study Report ” shall have the meaning ascribed to such term in Section 3.4.

“ Final Results Date ” means the date that the Results have been delivered to BMS hereunder.

“ Global Safety Database ” means the database containing Adverse Events, Serious Adverse Events, Serious Adverse Drug Reactions and pregnancy reports for the Combined Therapy, and shall be the authoritative data source for regulatory reporting and responding to regulatory queries with respect to the Combined Therapy Clinical Trial.

“ Good Clinical Practices ” or “ GCP ” means, as to the United States and the European Union, applicable good clinical practices as in effect in the United States and the European Union, respectively, during the Term and, with respect to any other jurisdiction, clinical practices equivalent to good clinical practices as then in effect in the United States or the European Union.

“ Good Laboratory Practices ” or “ GLP ” means, as to the United States and the European Union, applicable good laboratory practices as in effect in the United States and the European Union, respectively,

[***] = Certain Confidential Information Omitted

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during the Term and, with respect to any other jurisdiction, laboratory practices equivalent to good laboratory practices as then in effect in the United States or the European Union.

“ Good Manufacturing Practices ” or “ GMP ” means, as to the United States and the European Union, applicable good manufacturing practices as in effect in the United States and the European Union, respectively, during the Term and, with respect to any other jurisdiction, manufacturing practices equivalent to good manufacturing practices as then in effect in the United States or the European Union.

“ ICF ” shall have the meaning set forth in Section 5.1(f).

“ IND ” means (a) an Investigational New Drug Application as defined in the United States Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder, or any successor application or procedure required to initiate clinical testing of a drug in humans in the United States, (b) a counterpart of such an Investigational New Drug Application that is required in any other country before beginning clinical testing of a drug in humans in such country, including, for clarity, a “ Clinical Trial Application ” in the European Union, and (c) all supplements and amendments to any of the foregoing.

“ Indemnify ” shall have the meaning set forth in Section 11.1.

“ Infringe ” and “ Infringement ” means any infringement, or written allegation of infringement, by a Third Party, of applicable Patent Rights.

“ IRB ” means an Investigational Review Board or Ethics Committee (or similar body in a given country).

“ Licensee ” shall have the meaning set forth in Section 1.1(b).

“ Losses ” shall have the meaning set forth in Section 11.1.

“ Manufacture” or “ Manufacturing ” means manufacturing, processing, formulating, packaging, labeling, holding (including storage), and quality control testing of a Single Agent Compound or the Combined Therapy, in each case so as to be suitable for use in the Combined Therapy Clinical Trial under Applicable Law.

“ Material Safety Issue ” means a Party’s reasonable, good faith belief that there is an unacceptable risk for harm in humans based upon: (a) pre‑clinical safety data, including data from animal toxicology studies, or (b) the observation of Serious Adverse Events in humans after the Recipient Study Drug or the BMS Study Drug, either as a Single Agent Compound or in combination with another pharmaceutical agent (including as the Combined Therapy), has been administered to or taken by humans, such as during the Combined Therapy Clinical Trial.

“ NDA ” means (a) any new drug application or biologics license application filed with the FDA, or any successor application or procedure required to introduce a drug or biologic into commerce in the United States, (b) a counterpart of such a new drug application or biologics license application that is required in any other country before beginning the commercialization of a drug or a biologic in humans in such country, and (c) all supplements and amendments to any of the foregoing.

“ Non-Breaching Party ” shall have the meaning set forth in Section 12.2(a).

“ Officials ” shall have the meaning set forth in Section 10.9.

“ Ono ” means Ono Pharmaceutical Co., Ltd.

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“ Ono-BMS Agreements ” means those certain Collaboration Agreements between BMS and Ono dated as of September 20, 2011 and as of July 23, 2014, as amended from time to time, and agreements between Ono and BMS and their Affiliates relating thereto that may be in effect from time to time .

“ Ono Territory ” means Japan, South Korea and Taiwan.

“ Operational Matters ” shall have the meaning set forth in Section 5.1.

“ Party ” or “ Parties ” shall have the meaning set forth in the preamble to this Agreement.

“ Patent Right ” means any (a) United States or foreign patent, (b) United States or foreign patent application, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, and renewals (and all foreign equivalents of any of the foregoing), and all patents issued or granted on any such patent application, (c) United States or foreign patents-of-addition, reissues, reexaminations (including ex parte reexaminations, inter partes reviews, inter partes reexaminations, post grant reviews and supplemental examinations) and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates, patent term extensions and adjustments, or the equivalents thereof, and all foreign equivalents thereof, and (d) any other form of government-issued right substantially similar to any of the foregoing.

“ Payment ” shall have the meaning set forth in Section 10.9.

“ Person ” means any individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.

“ Personal Data ” means any information relating to an identified or identifiable natural person.

“ POTV ” shall have the meaning set forth in Section 9.6(a).

“ Prosecute ” means to prepare, file and prosecute any and all applications for Patent Rights (and including any proceedings relating to such prosecution, including reissues, reexaminations, protests, interferences, oppositions, post-grant reviews or similar proceedings and requests for patent extensions, and all foreign equivalents of any of the foregoing). The term “Prosecution ” shall have the corresponding meaning.

“ Protocol ” means the clinical trial protocol, for the clinical trial on the Combined Therapy to be conducted by Recipient under this Agreement, prepared by Recipient as provided in this Agreement, and as such protocol may be amended, update or modified by Recipient from time to time in accordance with this Agreement. The draft for such protocol as of the Effective Date is attached as Appendix B of this Agreement .

“ Publication Dispute ” shall have the meaning set forth in Section 9.5(b).

“ Quarter ” means a calendar quarter.

“ Recipient Class Drug ” means (i) the Recipient Study Drug, and (ii) any other small molecule antagonist that is designed to and does selectively bind to and inhibit VEGF and Tyro/Axl/Mer in a physiologically meaningful manner comparable to the Recipient Study Drug .

“ Recipient Indemnitees ” shall have the meaning set forth in Section 11.1.

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“ Recipient Independent Patent Right ” means any Patent Right (a) that is Controlled by Recipient or a Recipient Affiliate (i) as of the Effective Date, or (ii) during the Term that claims an invention that was conceived or first reduced to practice through activities other than those performed pursuant to this Agreement, and (b) that Covers the use (either alone or in combination with other agents), manufacture, formulation or composition of matter of the Recipient Study Drug.

“ Recipient Regulatory Documentation ” means any and all Regulatory Documentation of Recipient pertaining to the Recipient Study Drug that exists as of the Effective Date or that is created during the Term through efforts outside this Agreement.

“ Recipient Study Data ” shall have the meaning set forth in Section 8.2.

“ Recipient Study Drug ” means the Recipient’s proprietary sitravatinib compound, including salts thereof and any drug candidate or product containing such compound.

“ Recipient Study Invention ” means any Study Invention that pertains to: (a) the composition of matter of the Recipient Study Drug (and not the BMS Study Drug), (b) method of manufacture or formulation or administration, including dosing, of the Recipient Study Drug (and not the BMS Study Drug) as a Single Agent Compound, or (c) a method of use of the Recipient Study Drug (and not the BMS Study Drug) as a monotherapy or as used in combination with other agents, antibodies or compounds (other than use with the BMS Study Drug.

“ Recipient Study Patent Right ” means any Patent Right that Covers a Recipient Study Invention (and not a BMS Study Invention or a Combined Therapy Invention), excluding Recipient Independent Patent Rights and Recipient Technology. For avoidance of doubt, any Patent Right that Covers both (a) a Recipient Study Invention and (b) any other type of Study Invention is included within the Combined Therapy Patent Rights.

“ Recipient Technology ” means all Technology (a) that is Controlled by the Recipient (or its Affiliates) (i) as of the Effective Date, or (ii) during the Term and created through efforts outside of this Agreement, and (b) that is related directly to the Recipient Study Drug or the Combined Therapy, and (c) that is reasonably needed for the conduct of the Combined Therapy Clinical Trial and for BMS to exercise the rights granted to BMS under this Agreement. For clarity, all Study Inventions, Study Data, and Combined Therapy Clinical Trial Regulatory Documentation are excluded from the term Recipient Technology.

“ Regulatory Authority ” means the FDA or any governmental authority outside the United States (whether supranational, national, federal, provincial and/or local) that is the counterpart to the FDA, including the European Medicines Agency for the European Union.

“ Regulatory Documentation ” means, with respect to a Party’s Single Agent Compound, all submissions to Regulatory Authorities in connection with the development (including seeking regulatory approval or registration) of such Single Agent Compound, as applicable, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include clinical data).

“ Results ” shall have the meaning set forth in Section 9.5(b).

“ Right of Cross-Reference ” means, with regard to a Party, a grant of rights (including to or through another party) that allows the applicable Regulatory Authority in a country to have access to relevant information (by cross-reference, incorporation by reference or otherwise) contained in Regulatory

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Documentation (and any data contained therein) filed with such Regulatory Authority by or on behalf of the other Party (or its Affiliate) with respect to the other Party’s Single Agent Compound (and, in the case of BMS, the Right of Cross-Reference to the Combined Therapy IND), only to the extent reasonably needed for the conduct of the Combined Therapy Clinical Trial in such country or as otherwise expressly permitted or required under this Agreement to enable a Party to exercise its rights or perform its obligations hereunder, and, except as to information contained in the Combined Therapy IND pertaining to the Combined Therapy, without the disclosure of such information to such Party.

“ Safety Issue ” means any information suggesting an emerging safety concern or possible change in the risk-benefit balance for the BMS Study Drug, including information on a possible causal relationship between an Adverse Event and a drug, the relationship being unknown or incompletely documented previously.

“ Safety Signal ” means information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action.

“ Sample ” means a biological specimen collected under the Combined Therapy Clinical Trial from a study subject in such trial (including fresh and/or archived tumor samples, serum, peripheral blood mononuclear cells, plasma, and whole blood for RNA and DNA sample isolation).

“ Shortage ” shall have meaning set forth in Section 4.5.

“ Single Agent Compound ” or “ Compound ” means: (a) with respect to the Recipient, the Recipient Study Drug, as monotherapy, and (b) with respect to BMS, the BMS Study Drug, as monotherapy.

“ Sponsor ” means an applicant or holder of clinical studies applications/notifications.

“ Study Data ” means: (a) the actual raw results, records and data of the Combined Therapy Clinical Trial, including the case report forms (CRFs) for such study and all raw data as recorded in such CRFs; (b) all information relating to adverse events resulting from the Combined Therapy Clinical Trial, including all reports of Adverse Events, Serious Adverse Events, and Serious Adverse Drug Reactions; (c) all analyses of the raw results of the Combined Therapy Clinical Trial conducted using the statistical analysis plan and any bioanalysis plan pursuant to or set forth in the Protocol (or as otherwise agreed to by the Parties); and (d) the Final Study Report, the periodic reports (e.g. quarterly), and all other reports of the results of the Combined Therapy Clinical Trial or the analyses of such results prepared under this Agreement in accordance with the Protocol prior to the completion of the Final Study Report.

“ Study Invention ” means any Technology, whether or not patentable, that is made, conceived, or first actually reduced to practice by, for or on behalf of a Party, or by, for or on behalf of the Parties together, including by or with a Third Party in the performance of the Combined Therapy Clinical Trial, (a) pursuant to, in relation to, or in connection with the conduct of the Combined Therapy Clinical Trial to be conducted under this Agreement (including the analysis of the Study Data in connection with preparing the final study report for such trial, or (b) by the use of Study Data, but excluding in each case all Study Data.

“ Sunshine Laws ” shall have the meaning set forth in Section 9.6(c).

“ Supply and Quality Documentation ” shall have the meaning set forth in Section 4.3.

“ Technology ” means know-how, inventions, discoveries, trade secrets, knowledge, technology, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, specifications, data and

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results not generally known to the public (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and know-how, including study designs and protocols), and all other information, in all cases, whether or not patentable, in written, electronic or any other form now known or hereafter developed and materials, including Regulatory Documentation.

“ Term ” shall have the meaning set forth in Section 12.1.

“ Territory ” means all countries and territories in the world excluding those in the Ono Territory and the BeiGene Territory.

“ Third Party ” means any Person or entity other than the Recipient and BMS and their respective Affiliates.

“ Third Party Claim ” shall have the meaning set forth in Section 11.1.

“ Third Party License Payments ” means any payments (e.g., upfront payments, milestones, royalties) due to any Third Party under license agreements or other written agreements granting rights to intellectual property owned or controlled by such Third Party to the extent that such rights are necessary for (a) the making, using or importing of a Party’s Single Agent Compound for the conduct of the Combined Therapy Clinical Trial, or (b) the conduct of the Combined Therapy Clinical Trial.

“ Third Party Study Costs ” shall have the meaning set forth in Section 7.2.

“ Trial Site ” means a clinical site at which the Combined Therapy Clinical Trial is conducted on study subjects in such trial.

ARTICLE 2

SCOPE

2.1 Scope.

(a) The Recipient will use Commercially Reasonable Efforts to conduct the Combined Therapy Clinical Trial in accordance with the Protocol and the terms of this Agreement. The Recipient shall be solely responsible for the content of the Protocol; provided that : (i) the Recipient will notify BMS of any proposed amendments to the draft Protocol attached as Appendix A to this Agreement (or to the final Protocol initially approved by an IRB) and the Recipient will consider any comments provided by BMS regarding the proposed amendments (it being understood that the Parties will endeavor to set forth in writing the circumstances (e.g., administrative matters) where the Recipient may make specific Protocol amendments without the need for BMS to review and comment), and (ii) any changes to the draft Protocol attached as Appendix A (or to the final Protocol initially approved by an IRB) that pertain to the administration of the BMS Study Drug must be reviewed and expressly approved by BMS in writing (such approval not to be unreasonably withheld) or the change may not be implemented; provided however that BMS shall have [***] from the date on which the Recipient provides the applicable Protocol amendment to BMS to provide any comments to the Recipient concerning the proposed amendment, and, as to changes covered by subsection (ii) above, to approve or reject approval of such proposed change, and if such change is not expressly disapproved by BMS within such period, Recipient may amend the protocol accordingly, and such change shall be deemed to have been approved by BMS for purposes of Recipient’s compliance with this Section 2.1(a).

[***] = Certain Confidential Information Omitted

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(b) The Combined Therapy Clinical Trial shall be conducted under a combination IND, for which the Recipient will be the Sponsor of record (the “ Combined Therapy IND ”), and shall be conducted only in the Territory. The Recipient shall be the sole holder of all legal interests in the Combined Therapy IND; provided, however, that the Recipient may not grant any Third Party any Right of Cross-Reference with respect to any portion of the Combined Therapy IND pertaining to BMS’s Single Agent Compound for use as monotherapy or for use in combination with any molecules, agents, antibodies or compounds other than with the Recipient Study Drug.

(c) BMS will make its current package insert for the BMS Study Drug in the Territory available to the Recipient and will provide Recipient any updates thereto at the same time as the same are made publicly available.

(d) If the Recipient and BMS agree that Recipient reasonably needs access to the investigator’s brochure for the BMS Study Drug in order for a Trial Site to conduct the Combined Therapy Clinical Trial, then (i) BMS will provide the current version of its Investigator Brochure to the Recipient promptly and (ii) will thereafter, until the conclusion of the Combined Therapy Clinical Trial, provide to the Recipient, upon reasonable request, the latest investigator’s brochure for the BMS Study Drug or any amendments thereto in accordance with BMS’s customary practices for same. The Recipient shall, and shall require that each applicable Trial Site for the Combined Therapy Clinical Trial shall, use any such data provided pursuant to this Section 2.1(d) solely (A) to evaluate the safety and efficacy of the BMS Study Drug and the Combined Therapy for use in Combined Therapy Clinical Trial, (B) to meet any regulatory requirements pertaining to the conduct of the Combined Therapy Clinical Trial, and (C) to enable the Recipient to draft and update as necessary the investigator’s brochure for the Combined Therapy Clinical Trial. The Recipient will ensure that the applicable Trial Sites for the Combined Therapy Clinical Trial are obligated to protect such information and disclosures as set forth in Article 9. The Recipient’s right to use the investigator’s brochure provided by BMS shall terminate upon the expiration or termination of the Combined Therapy Clinical Trial and shall not be used for purposes of conducting any other clinical studies.

(e) If reasonably required and requested in writing by the Recipient, BMS shall provide Rights of Cross-Reference to its existing Regulatory Documentation for BMS’s Single Agent Compound for those countries in the Territory where the Combined Therapy Clinical Trial will be conducted solely as reasonably needed to allow the Combined Therapy Clinical Trial to be conducted under the Combined Therapy IND in each applicable country; provided that such Right of Cross-Reference shall terminate upon the expiration or termination of this Agreement and shall not be used for purposes of conducting any other clinical studies, except (a) as set forth in Section 3.1(b) and Section 8.3, and (b) that, in the case of termination for a Material Safety Issue pursuant to Section 12.4, such Rights of Cross-Reference shall remain in effect solely (i) to the extent necessary to permit the Recipient to comply with any outstanding obligations required by a Regulatory Authority and/or Applicable Law or (ii) as necessary to permit the Recipient to continue to dose subjects enrolled in the Combined Therapy Clinical Trial through completion of the Protocol if required by the applicable Regulatory Authority(ies) and/or Applicable Laws.

(f) If PD-L1 biomarker testing is required by the Protocol, the Recipient agrees to use the commercially available [***] Assay to perform such testing.

(g) The Recipient shall refer to the applicable BMS Study identification number in all Combined Therapy Clinical Trial reports, reports of Serious Adverse Events, BMS Study Drug requests, and all other material submissions or communications to BMS relating to the Protocol.

[***] = Certain Confidential Information Omitted

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2.2	Adverse Event Reporting.

(a) This Section 2.2 shall govern safety reporting arising from the Combined Therapy Clinical Trial. The Recipient will manage all drug safety reporting activities for the Combined Therapy Clinical Trial.

(b) The Recipient will forward to BMS at the contact information below via fax or secure e-mail in a format to be agreed to by the Parties all fatal or life threatening SAE reports arising in the Combined Therapy Clinical Trial within [***] of Date of First Receipt of such report, and all other SAE reports, reports of exposure during pregnancy (maternal and paternal) and reports of suspected transmission of an infectious agent via the BMS Study Drug or Combined Therapy within [***] of Date of First Receipt, in each case for the BMS Study Drug and the Combined Therapy administered in the Combined Therapy Clinical Trial.



BMS – Adverse Event Reporting Contact
E-mail	[***]
Fax	[***]
Acknowledgment of ICSR receipt:	[***]

(c) Each Party shall collect, use and disclose Personal Data obtained in the course of performing the pharmacovigilance activities under this Section 2.2 solely for the purposes of complying with the regulatory obligations as described in this Agreement, or as otherwise required by Applicable Law or by a court order. Both Parties will use electronic, physical, and other safeguards appropriate to the nature of the information to prevent any use or disclosure of Personal Data other than as provided for by this Agreement and permitted under the ICF. Both Parties will also take reasonable precautions to protect such Personal Data from accidental, unauthorized, or unlawful alteration or destruction. Each Party will notify the other Party promptly of any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access of such Personal Data.

(d) The Recipient will promptly make available to BMS upon request such records that the Recipient Controls as is needed or useful for BMS to perform medical assessment of any Adverse Event associated with the use of the BMS Study Drug or Combined Therapy reported during the Combined Therapy Clinical Trial that is forwarded to BMS under this Agreement. The Recipient will designate a single point of contact within its organization (and will provide to BMS the email address of such point of contact prior to the start of the Combined Therapy Clinical Trial) for any pharmacovigilance-related follow-up questions that BMS would have as to such Adverse Events.

(e) The Recipient shall perform case level reconciliation to confirm that BMS has received all reports required under this Agreement. The Recipient shall e-mail [***] to request a reconciliation report for the Combined Therapy Clinical Trial. The Recipient shall reconcile the cases identified as being transmitted to BMS on BMS’s reconciliation report and those contained in the Combined Therapy Clinical Trial database. The Recipient shall send missing case-level events to BMS Global Pharmacovigilance at [***] or by fax at [***]. The Recipient shall perform such reconciliation every [***], unless otherwise agreed by BMS in writing.

(f) As Sponsor, the Recipient will be responsible for submitting all applicable Individual Case Safety Reports (ICSRs) and aggregate report submissions to Regulatory Authorities for the Combined Therapy Clinical Trial. The Recipient will provide BMS with the final version of any aggregate

[***] = Certain Confidential Information Omitted

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report at the time of submission. The Recipient will also submit appropriate safety letters or safety reports to study investigators, the reviewing IRB and authorized Regulatory Authorities in accordance with Applicable Law.

(g) In the event that BMS produces any Development Safety Update Report (“ DSUR ”) in respect to the BMS Study Drug, BMS will provide to the Recipient upon request, and for the duration of the Combined Therapy Clinical Trial, copies of the executive summary and any line listings of Serious Adverse Drug Reactions extracted from the final DSUR for information purposes only and to assist the Recipient in generation of their own clinical trial aggregate report, where applicable. The Recipient agrees not to forward such BMS DSUR sections to any Third Party, except to its Affiliates, consultants, advisors and contractors under obligations of confidentiality for generation of such a clinical trial aggregate report.

(h) If the Recipient determines there is a significant Safety Issue or significant Safety Signals arising in the Combined Therapy Clinical Trial that may be associated with the BMS Study Drug or Combined Therapy, the Recipient will disclose such information to BMS promptly after such determination.

(i) BMS will ensure that any urgent Safety Issues or Safety Signals relating to the BMS Study Drug are communicated to the Recipient promptly after such determination.

2.3 Clinical Study Designated Contact. Each Party will designate an employee within its organization (the “ Designated Clinical Contact ”) who will coordinate and/or facilitate:

(a) the review of Protocol amendments submitted by the Recipient for BMS approval and with whom comments thereon may be discussed;

(b) any BMS clinical and regulatory responsibilities and communications regarding the Combined Therapy Clinical Trial;

(d) discussion of any other topics or issues relating to the Combined Therapy Clinical Trial requested by the Recipient or BMS.

2.4 Conduct. Each Party shall use Commercially Reasonable Efforts to (a) perform and fulfill its respective activities and obligations under the Combined Therapy Clinical Trial and this Agreement on a timely basis and in an effective manner consistent with prevailing standards, (b) supply the quantities of its Compound in accordance with Article 4 as needed to conduct the Combined Therapy Clinical Trial on a timely basis, and, in the case of the Recipient, package and deliver same to study sites on a timely basis, and (c) in the case of the Recipient, conduct and complete the Combined Therapy Clinical Trial on a timely basis in accordance with the Protocol and Third Party agreements relating thereto, and provide sufficient resources, funding and personnel to conduct and perform the Combined Therapy Clinical Trial on a timely basis in accordance with the Protocol for same and the terms of this Agreement. Each Party shall perform its duties and obligations in relation to the Combined Therapy Clinical Trial in accordance with Applicable Law, including GCP, GLP and GMP as applicable.

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ARTICLE 3

LICENSE GRANTS

3.1 Grants by BMS.

(a) BMS hereby grants, and shall cause its Affiliates to grant (effective as of the Effective Date), to Recipient and Recipient’s Affiliates a non-exclusive, non-transferable, royalty-free license (with the right to sublicense solely pursuant to the terms of and subject to the limitations of Section 3.3) under the BMS Independent Patent Rights, BMS Technology and BMS Regulatory Documentation to use the BMS Study Drug in research and development, in the Territory, solely to the extent reasonably needed to conduct the Combined Therapy Clinical Trial subject to and in accordance with the terms and conditions of this Agreement.

(b) BMS hereby grants, and shall cause its Affiliates to grant (effective as of the Effective Date), to Recipient and Recipient’s Affiliates a non-exclusive, irrevocable, sublicensable (through multiple tiers of sublicensees), and subject to the terms of Section 3.3(b)), royalty-free license, in the Territory, under the BMS Independent Patent Rights, BMS Technology and BMS Regulatory Documentation solely in the Territory (i) to seek and maintain Regulatory Approvals of the Recipient Study Drug, and (ii) upon any such Regulatory Approval, to market and promote the Recipient Study Drug solely for use in the Combined Therapy in any manner that is consistent with the Regulatory Approval for the Recipient Study Drug, which license to market and promote shall survive any expiration or termination of this Agreement. The rights granted under this Section 3.1(b) include Rights of Cross-Reference to the relevant BMS Regulatory Documentation solely to the extent reasonably needed for obtaining, and solely for the purpose to obtain, Regulatory Approval in the Territory for the Recipient Study Drug for use in a Combined Therapy based upon a Combined Therapy Clinical Trial (which Rights of Cross-Reference shall survive any expiration or termination of this Agreement). With respect to such Rights of Cross-Reference, BMS shall reasonably assist and cooperate with Recipient to effect such Rights of Cross-Reference, including by making written authorizations and other filings with the applicable Regulatory Authority as reasonably needed to effect or implement such Rights of Cross-Reference. For avoidance of doubt, (A) no rights are granted under this Section 3.1(b) outside of the Territory, (B) no rights are granted except for use of the Recipient Study Drug in a Combined Ther apy (i. e., use of the Recipient Study Drug in combination with the BMS Study Drug), with no rights being granted for the use of any other compound or therapeutic agent other than the Recipient Study Drug as part of a combination with the BMS Study Drug and (C) no rights are granted with respect to the BMS Study Drug as a monotherapy or in combination with any other compound or therapeutic agent.

3.2 Grants by Recipient.

(a) Recipient hereby grants, and shall cause its Affiliates to grant (effective as of the Effective Date), to BMS and BMS’ Affiliates a non-exclusive, non-transferable, royalty-free license (with the right to sublicense solely pursuant to the terms of and subject to the limitations of Section 3.3), under the Recipient Independent Patent Rights, Recipient Technology and Recipient Regulatory Documentation to use the Recipient Study Drug in research and development, in the Territory, solely to the extent reasonably needed to conduct the Combined Therapy Clinical Trial subject to and in accordance with the terms and conditions of this Agreement.

(b) Recipient hereby grants, and shall cause its Affiliates to grant (effective as of the Effective Date), to BMS and BMS’s Affiliates a non-exclusive, sublicensable (through multiple tiers of sublicensees, and subject to the terms of Section 3.3(b)), irrevocable, royalty-free license under the Recipient Independent Patent Rights, Recipient Technology and Recipient Regulatory Documentation solely in the Territory (i) to seek and maintain Regulatory Approvals of the BMS Study Drug, and (ii) upon

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any such Regulatory Approval, to market and promote the BMS Study Drug solely for use in the Combined Therapy in any manner that is consistent with the Regulatory Approval for the BMS Study Drug, which license to market and promote shall survive any expiration or termination of this Agreement. The rights granted under this Section 3.2(b) include Rights of Cross-Reference to the relevant Recipient Regulatory Documentation solely to the extent reasonably needed to obtain, and solely for the purpose to obtain, Regulatory Approval in the Territory for the BMS Study Drug for use in a Combined Therapy based upon a Combined Therapy Clinical Trial (which Rights of Cross-Reference shall survive any expiration or termination of this Agreement). With respect to such Rights of Cross-Reference, Recipient shall reasonably assist and cooperate with BMS to effect such Rights of Cross-Reference, including by making written authorizations and other filings with the applicable Regulatory Authority reasonably needed to effect such Rights of Cross-Reference. For avoidance of doubt, (A) no rights are granted under this Section 3.2(b) outside of the Territory, (B) no rights are granted except for use of the BMS Study Drug in a Combined Therapy (i.e., use of the BMS Study Drug in combination with the Recipient Study Drug), with no rights being granted for the use of any other compound or therapeutic agent other than the BMS Study Drug as part of a combination with the Recipient Study Drug, and (C) no rights are granted with respect to the Recipient Study Drug as a monotherapy or in combination with any other compound or therapeutic agent.

3.3 Sublicensing.

(a) (i) Either Party shall have the right to grant sublicenses under the licenses granted to it under Sections 3.1(a) and 3.2(a) (as applicable), to Affiliates and to Third Parties (including Trial Sites), if reasonably needed for an Affiliate or such Third Party to perform its duties with respect to the conduct of the Combined Therapy Clinical Trial, solely as reasonably needed to assist the Recipient in carrying out its responsibilities with respect to the Combined Therapy Clinical Trial, and (ii) Recipient shall have the right to grant sublicenses to Trial Sites under the BMS Study Inventions and BMS Study Patent Rights for non-commercial, internal research and teaching purposes and for patient care purposes.

(b) With regard to any sublicenses made under this Agreement as permitted hereunder, (i) the sublicensees, except Affiliates (so long as they remain Affiliates), shall be subject to written agreements that bind such sublicensees to obligations that are consistent with such Party’s applicable obligations under this Agreement including confidentiality and non-use provisions no less restrictive than those set forth in herein, and provisions regarding intellectual property that ensure that the Parties will have the rights provided under this Agreement to any intellectual property [***], (ii) except [***], each sublicensing Party shall provide written notice to the other Party of any such sublicense and shall consider in good faith the reasonable input of the other Party with respect to the proposed sublicensee; and (iii) each sublicensing Party shall remain liable to the other Party for all actions of its sublicensees.

3.4 Negotiation Period. Promptly after completion of the Combined Therapy Clinical Trial, Recipient shall provide BMS with a final report pertaining to the Study Data resulting from the Combined Therapy under the Combined Therapy Clinical Trial (“ Final Study Report ”). Commencing on the date that BMS receives the Final Study Report and for a subsequent period of [***] (the “ Negotiation Period ”) BMS will have the right to negotiate (but subject to the terms of Section 3.5) with Recipient in good faith the terms of a commercial agreement related to development and commercialization of the Recipient Study Drug in the Territory (the “ Definitive Commercial Agreement ”). The Negotiation Period may be extended upon mutual written agreement by the Parties. During the Negotiation Period, Recipient will not negotiate with Third Parties for development or commercialization rights to the Recipient Study Drug in the Territory. Should the Parties not agree to all the material terms of such a Definitive Commercial Agreement, [***], within the Negotiation Period, Recipient shall thereafter be free to negotiate and enter into a license or any other type of transaction with a Third Party regarding the Recipient Study Drug in the Territory (or any part thereof).

[***] = Certain Confidential Information Omitted

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3.5 BMS’ and Recipient’s Rights in Third Party Negotiations . [***]. If the Parties do not execute such license agreement [***] Recipient [***] may enter into an agreement with Third Parties granting such development and commercialization rights to the Recipient Study Drug in the Territory (or part thereof).

3.6 No Implied Licenses . Except for the rights as specifically and expressly granted and set forth in this Agreement, neither Party shall acquire any license or other intellectual property interest, by implication or otherwise, in any intellectual property of the other Party, including Confidential Information disclosed to it under this Agreement or under any Patent Rights Controlled by the other Party or its Affiliates.

ARTICLE 4

MANUFACTURE AND SUPPLY

ARTICLE 44.1 Recipient Study Drug Manufacture and Supply.

(a) The Recipient shall be responsible, at its sole costs and expense, for manufacturing, packaging and labeling (or having manufactured, packaged or labeled) GMP-grade quantities of the Recipient Study Drug, as well as obtaining any other drug (other than the BMS Study Drug provided by BMS pursuant to Section 4.2) required for the conduct of the Combined Therapy Clinical Trial, and shall package and label if and as required by the Protocol and/or applicable Regulatory Authorities all drugs (including the BMS Study Drug) used in the Combined Therapy Clinical Trial, on a timely basis and in accordance with applicable specifications as required for the conduct of the Combined Therapy Clinical Trial. The Recipient Study Drug shall be manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the Recipient Study Drug used by the Recipient for its other clinical trials of the Recipient Study Drug.

(b) The Recipient shall provide BMS with prompt notice of any Manufacturing and supply issues with respect to the Recipient Study Drug or BMS Study Drug of which it becomes aware that may adversely impact the conduct or timelines of the Combined Therapy Clinical Trial.

4.2 BMS Study Drug.

(a) Manufacture and Supply. BMS shall Manufacture or have Manufactured the BMS Study Drug in such quantities as reasonably needed, and at the points in time as needed to meet the timelines in the Protocol and in Recipient’s clinical plan, for the Combined Therapy Clinical Trial, and shall supply such BMS Study Drug as commercially labeled or unlabeled vials to the Recipient or its designee

[***] = Certain Confidential Information Omitted

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for use solely in the Combined Therapy Clinical Trial. The Recipient will at its sole expense, package and label the BMS Study Drug for use in the Combined Therapy Clinical Trial to the extent necessary. The cost of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Study Drug for the Combined Therapy Clinical Trial shall be borne solely by BMS, and BMS shall bear the risk of loss for such quantities of BMS Study Drug until delivery of such quantities of BMS Study Drug to the Recipient or its designee. BMS shall be responsible for the payment of any Third Party License Payments that may be due based on the manufacture, supply and use of the BMS Study Drug used in the Combined Therapy Clinical Trial. The BMS Study Drug shall be manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Study Drug used by BMS for its other clinical trials of the BMS Study Drug. BMS shall deliver certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Recipient to compare the BMS Study Drug certificate of analysis to the BMS Study Drug specifications. Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the regulatory compliance of the quality of the BMS Study Drug at the time the BMS Study Drug is delivered to the Recipient with the regulatory filings in the countries in the Territory where the Combined Therapy Clinical Trial will be performed. Subject to Section 4.6, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to supply or use of the BMS Study Drug in connection with this Agreement.

(b) Use of BMS Study Drug Supplied by BMS to the Recipient. The Recipient shall use the quantities of BMS Study Drug supplied to it under this Agreement solely as reasonably needed for, and in accordance with, this Agreement and the Protocol, and for no other purpose, including as a reagent or tool to facilitate its internal research efforts, for any commercial (i.e., non-clinical) purpose, or for other clinical or non-clinical research unrelated to the Combined Therapy Clinical Trial. Except as may be required or expressly permitted by the Protocol or the Supply and Quality Documentation, the Recipient shall not perform, and shall not allow any Third Party to perform, any analytical testing of the quantities of BMS Study Drug supplied to it under this Agreement. If Study Drug supplied by BMS is (after delivery by BMS) lost, damaged, destroyed or becomes (due to fault other than BMS) unable to comply with applicable specifications while under the control of the Recipient or any of its (sub)contractors, including common carriers and clinical study sites contracted by the Recipient, BMS shall not be obligated to replace same, and if BMS does elect to do so, BMS may elect to charge the Recipient a reasonable replacement cost to replace same. If BMS Study Drug supplied by BMS is at delivery non-conforming with the warranty in Section 10.12, or after delivery becomes non-conforming due to fault of BMS, then BMS shall, as soon as practicable thereafter, supply to Recipient (or its designee) replacement BMS Study Drug that conforms with such warranty, at no cost to Recipient.

4.3 Supply and Quality Documentation. BMS shall supply the BMS Study Drug to the Recipient in accordance with such reasonable and typical supply and quality addenda or agreement(s) as the Parties may agree reasonably and in good faith (the “ Supply and Quality Documentation ”). The Parties shall finalize and execute the Supply and Quality Documentation within [***] of the Effective Date, but in no event later than the date on which the first shipment of the BMS Study Drug is supplied for use in the Combined Therapy Clinical Trial. The Supply and Quality Documentation shall outline the additional roles and responsibilities relative to the quality of BMS Study Drug in support of the Combined Therapy Clinical Trial. It shall include the responsibility for quality elements as well as exchanged GMP documents and certifications required to release the BMS Study Drug for the Combined Therapy Clinical Trial. In addition, the Supply and Quality Documentation shall detail the documentation required for each shipment of BMS Study Drug supplied to the Recipient or its designee for use in the Combined Therapy Clinical Trial.

4.4 Supply Forecast. Estimated supply and delivery details will be outlined in the Supply and Quality Documentation and will be updated by the Parties by mutual agreement (which agreement can be

[***] = Certain Confidential Information Omitted

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effected by the Parties’ Designated Supply contacts and without need for an amendment to this Agreement) based on the actual enrollment. The Recipient will promptly inform BMS of any change in its requirements, and BMS will endeavor to accommodate any change in the supply quantities requested by the Recipient so long as it does not unduly disrupt BMS’s ongoing business activities.

4.5 Shortages. In the event of a supply interruption or shortage of BMS Study Drug as determined by BMS pursuant to its internal processes and policies (a “ Shortage ”), such that BMS reasonably believes that it will not be able to fulfill its supply obligations under this Agreement, BMS will provide prompt written notice thereof to the Recipient (including the quantity of BMS Study Drug that BMS reasonably estimates it will be able to supply) and, upon request, the Parties will promptly discuss such situation (including how the quantities of BMS Study Drug that BMS is able to supply under this Agreement will be allocated within the Combined Therapy Clinical Trial). Notwithstanding anything to the contrary contained herein, in the event of a Shortage of the BMS Study Drug, BMS will have reasonable discretion, subject to Applicable Law, to determine the quantity of BMS Study Drug it will be able to supply as a result of such Shortage; provided, however, that BMS shall consider reasonably and in good faith the needs of patients who are actively being treated with BMS Study Drug, including Combined Therapy Clinical Trial patients, in making such determination. Subject to BMS’ compliance with the foregoing, and provided BMS uses good faith, Commercially Reasonable Efforts to resolve any such Shortage, BMS will not be deemed to be in breach of this Agreement for failure to supply any other quantities of BMS Study Drug hereunder as a result of a Shortage and any such allocation of the BMS Study Drug performed in accordance with this Section 4.5 will be the Recipient’s exclusive remedy pertaining to supply of BMS Study Drug with respect to a Shortage.

4.6 Participating Countries; Customs Valuation. The Recipient will provide BMS in writing with a list of each country in which it proposes to conduct the Combined Therapy Clinical Trial prior to [***]. During the conduct of the Combined Therapy Clinical Trial, the Recipient will send in writing any changes to the list of participating countries to BMS [***] prior to the end of each Quarter. If no changes are sent to BMS by the Recipient for a particular Quarter, the prior Quarter’s participating country list will be used as the basis for customs valuation for that Quarter. BMS will provide the Recipient with country-specific customs valuations initially for the BMS Study Drug prior to initiation of the Combined Therapy Clinical Trial and at the end of each Quarter during the conduct of the Combined Therapy Clinical Trial. The Recipient will use the BMS provided values for the import/export process to the listed participating countries and not make any change to such valuations without BMS’s prior written consent.

4.7 Designated Supply Contact. Each Party will designate an individual (the “ Designated Supply Contact ”) that a Party may contact to assist with coordinating supplies and facilitating the resolution of any issues or concerns arising in connection with the supply of the BMS Study Drug for use in the Combined Therapy Clinical Trial, except as required by Applicable Law.

ARTICLE 5

RESPONSIBILITIES

5.1 Specific Responsibilities of the Recipient. The Recipient shall, subject to the terms of the Protocol, applicable terms and conditions of this Agreement, and any other written agreement between the Parties relating to the Combined Therapy Clinical Trial, manage and be responsible for the conduct of the Combined Therapy Clinical Trial, including timelines and contingency planning. In particular, and not in limitation of the foregoing, the Recipient shall use Commercially Reasonable Efforts to perform (itself and/or through Third Parties, including Trial Sites, CROs and investigators) and/or be responsible for the following (items (a) to (p) below, collectively the “ Operational Matters ”) with respect to the Combined Therapy Clinical Trial:

[***] = Certain Confidential Information Omitted

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(a) compiling, amending and filing all necessary Combined Therapy Clinical Trial Regulatory Documentation with Regulatory Authority(ies), maintaining and acting as the sponsor of record as provided in 21 CFR 312.50 (and applicable comparable ex-US laws) with responsibility, unless otherwise delegated in accordance with 21 CFR 312.52 (and applicable comparable ex-US laws), for the Combined Therapy Clinical Trial and making all required submissions to Regulatory Authorities related thereto on a timely basis;

(b) conducting clinical study start-up activities, communicating with and obtaining approval from IRBs for the Protocol and other relevant documents, and clinical study subject recruitment and retention activities, all for the Combined Therapy Clinical Trial;

(c) listing of the Combined Therapy Clinical Trial, if it is required to be listed on a public database, on www.clinicaltrials.gov or other applicable public registry in any country in which such Combined Therapy Clinical Trial is being conducted, all in accordance with Applicable Law and in accordance with Recipient’s internal policies relating to clinical trial registration;

(d) providing BMS with [***] notice of meetings or other non-written communications with a Regulatory Authority regarding the Combined Therapy Clinical Trial, and the opportunity to participate in each such meeting or other non-written communication to the extent such meeting or communication involves a safety, efficacy or toxicology issue relating to the Combined Therapy or the BMS Study Drug or any other matter that likely could have an adverse effect on the BMS Study Drug. In such case that Recipient intends to provide such a communication that relates to the BMS Study Drug, the Recipient will provide BMS with the opportunity to review, provide comments to the Recipient within [***] on, and, if inconsistent with the Protocol, approve such submissions and written correspondence with a Regulatory Authority to the extent that it relates to the BMS Study Drug;

(e) provide BMS (i) a written summary of meetings or other non-written communications with a Regulatory Authority within [***] of such meeting or communication, and (ii) copies of any official correspondence to or from a Regulatory Authority within [***] of receipt or provision, in each case of (i) or (ii) to the extent involving a safety, efficacy or toxicology issue relating to the Combined Therapy or the BMS Study Drug or any other matter that likely could have an adverse effect on the BMS Study Drug, and copies of all material Combined Therapy Clinical Trial Regulatory Documentation and correspondence that relates to same within [***] of submission to Regulatory Authorities;

(f) subject to the terms of this Agreement, the selection and payment of, negotiation of the terms of, contracting with, managing and overseeing compliance of its agreement by and the receipt of contract deliverables from, any CRO or vendor selected by the Recipient to assist in the performance of the Combined Therapy Clinical Trial. The Recipient shall have the sole rights and responsibility to determine and approve contract deliverables and manage contract performance, including executing Trial Site contracts, drafting and obtaining IRB approval for Trial Site informed consent forms (each an “ ICF ”), obtaining signed ICFs, and monitoring clinical plans. The Recipient will be responsible for ensuring that, to its knowledge, the terms of all such contracts and ICFs: (i) do not conflict with the terms of this Agreement, (ii) allow the Recipient [***] access to and use of Study Data, Samples, and other applicable information and documents resulting from the Combined Therapy Clinical Trial as required pursuant to this Agreement (and in no event less than the same use rights thereto granted to Recipient), (iii) do not by their express terms adversely affect the BMS Technology or BMS Independent Patent Rights (or the enforcement or defense thereof), the [***] Assay, the Combined Therapy, or the BMS Study Drug as monotherapy, (iv) do not impose a new obligation, whether direct, indirect, or contingent, upon BMS that is not set forth in this Agreement, (v) retain each of the Parties’ respective intellectual property rights in the Recipient Study Drug, BMS Study Drug and Combined Therapy consistent with this Agreement, and (vi) comply with Applicable Law;

[***] = Certain Confidential Information Omitted

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(g) providing BMS with copies of the [***]. The Recipient shall ensure that each ICF does not impose any financial obligation, liability, damages or other cost upon BMS with respect to any injury (including death) suffered by a Combined Therapy Clinical Trial subject whether or not resulting from the administration of the BMS Study Drug or direct a study subject to BMS to seek reimbursement for any costs or seek compensation for any injury incurred in connection with the Combined Therapy Clinical Trial;

(h) if requested by BMS, providing BMS within [***] with minutes from any and all external drug safety monitoring boards for the Combined Therapy Clinical Trial after receipt by the Recipient, to the extent relating to the BMS Study Drug or the Combined Therapy;

(i) informing and updating BMS [***] (with significant issues to be communicated promptly after the Recipient becomes aware of same) regarding a reasonable summary of all Operational Matters, so that if BMS has any significant concerns or material disagreements regarding same, the matter can be discussed with the Recipient. It is expected that at least one of the [***] updates each calendar year during the Term shall be in person at a Recipient facility (or as otherwise agreed). The other [***] meetings in a calendar year need not be in person and may be by telephone or any other method determined by the Parties. Each Party will bear its own costs associated with attending such meetings. Without limiting the foregoing, the Recipient shall inform BMS [***] as to the overall Combined Therapy Clinical Trial progress -- information regarding the number and status of study sites, the number of screened subjects (actual to target), the number of any randomized subjects (actual to target), the number of dosed, ongoing, discontinued and completed subjects, any safety updates as contemplated by the Protocol, and/or routinely performed by the Recipient in its normal course of trial management and reporting, and any other Combined Therapy Clinical Trial-related matters reasonably requested by BMS to the extent involving a safety, efficacy or toxicology issue relating to the Combined Therapy or the BMS Study Drug or any other matter that likely could have an adverse effect on the BMS Study Drug; provided however that the Parties may agree to meet (including by telephone) on a more frequent basis, if reasonably requested by either Party, to discuss any of the foregoing;

(j) owning and being responsible for (or appointing a Third Party to be responsible for) the maintenance of the Global Safety Database and being responsible for safety reporting, collecting, evaluating and reporting Serious Adverse Events, other safety data and any further pharmacovigilance information from the Combined Therapy Clinical Trial;

(k) analyzing the Study Data in a timely fashion and providing BMS with access to the Study Data after Recipient is in possession thereof, as follows:

(i) top line data and a copy of all Clinical Study Reports (CSRs) for the Combined Therapy Clinical Trial, in each case, [***] after being received by the Recipient’s clinical management;

(ii) if requested by BMS, sharing with BMS for review and comment drafts of interim and/or final clinical trial report (and/or statistical analysis in accordance with the Protocol) from the Combined Therapy Clinical Trial;

(iii) if requested by BMS, within [***] after database lock, access to those safety databases that will be used for any interim review by an external consultant (or drug safety monitoring board, if required) for the Combined Therapy Clinical Trial;

(iv) if requested by BMS, within [***] after database lock, access to case report forms or patient profiles for all patients in the Combined Therapy Clinical Trial;

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(v) if requested by BMS, within [***] of the creation of an electronic clean database for the Combined Therapy Clinical Trial, an electronic copy of the clean database (the form and format of the clean database to be reasonably acceptable to both Parties);

(vi) if requested by BMS, subject to any third party requirements, providing BMS with any programs or SAS codes to be used for any statistical analysis plan for the Combined Therapy Clinical Trial; and

(vii) (A) safety analyses, (B) new and/or changing Safety Signals and Safety Issues, (C) new and/or changing toxicology and efficacy signals, and (D) any statistical analysis, immunogenicity analysis, or bioanalysis, in each case relating to the BMS Study Drug, the Recipient Study Drug and/or the Combined Therapy, arising from or in connection with the conduct of the Combined Therapy Clinical Trial, as and when the same are received by the Recipient;

(l) obtaining supplies of any co-medications, to the extent any such co-medications are required for use in the Combined Therapy Clinical Trial, and providing to BMS any information related to the Combined Therapy Clinical Trial that is provided to the manufacturer of any co-medication within [***] after the provision of the information to the manufacturer;

(m) if reasonably requested by BMS, providing information regarding the pharmacokinetics, efficacy and safety of the Recipient Study Drug alone or in combination with the BMS Study Drug in the Combined Therapy Clinical Trial;

(n) performing either directly or through third parties collection of Samples required by the Protocol;

(o) handling and addressing inquiries from the Combined Therapy Clinical Trial subjects and investigators; and

(p) such other responsibilities as may be agreed to in writing by the Parties.

5.2 BMS Operational Responsibilities. BMS shall be responsible for the following activities:

(a) Manufacturing and supplying GMP-grade quantities of the BMS Study Drug, as further described in Article 4 above, and, where and to the extent provided in the Supply and Quality Documentation, providing GMP information and documentation that is reasonably needed by the Recipient Qualified Person (as such term will be defined in the Supply and Quality Documentation) to release BMS Study Drug for the Combined Therapy Clinical Trial;

(b) where and to the extent provided in the Supply and Quality Documentation, providing for the release by a BMS Qualified Person or providing the necessary documentation in support of such quality release, of the BMS Study Drug if such release is required for the Combined Therapy Clinical Trial;

(c) to the extent reasonably needed for the conduct of the Combined Therapy Clinical Trial, providing a Right of Cross-Reference to the relevant Regulatory Documentation for the BMS Study Drug as set forth in Section 2.1(b) and/or (e), if applicable, to the BMS investigator’s brochure for the BMS Study Drug (and updates thereto) as provided in Section 2.1(d); and

(d) such other responsibilities as may be agreed to in writing by the Parties.

5.3 Other Clinical Trials. Except as set forth in Section 3.4, nothing in this Agreement shall preclude either Party from conducting any other clinical trials as it may determine in its discretion, so long

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as it does not use or rely on the Confidential Information that is solely owned by the other Party in doing so .

5.4 Subsequent Studies. Should additional clinical studies to evaluate the Combined Therapy (“Subsequent Studies”) be of interest to either Party during the Term, the Parties will discuss such studies in good faith. If a Subsequent Study is of mutual interest to both Parties, such Subsequent Study collaboration would be conducted as provided and addressed in a separate written agreement between the Parties.

ARTICLE 6

INTELLECTUAL PROPERTY

6.1 Inventions and related Patent Rights. All rights to Study Inventions shall be allocated as follows:

(a) Recipient Ownership. Subject to the terms of this Agreement, all Recipient Study Inventions and Recipient Study Patent Rights shall be owned solely by the Recipient, and the Recipient will have the full right to exploit such Recipient Study Inventions and Recipient Study Patent Rights without the consent of, or any obligation to account to, BMS. BMS shall assign and hereby assigns (and shall cause its Affiliates and contractors to assign) the entire rights, title and interests in any Recipient Study Inventions and Recipient Study Patent Rights to the Recipient. BMS shall execute such further documents and provide other assistance as may be reasonably requested by the Recipient to perfect the Recipient’s rights in all such Recipient Study Inventions and Recipient Study Patent Rights, all at the Recipient’s expense. The Recipient shall have the sole right, but not any obligation, to Prosecute and maintain any Recipient Study Patent Rights at its own expense.

(b) BMS Ownership. Subject to the terms of this Agreement, all BMS Study Inventions and BMS Study Patent Rights shall be owned solely by BMS, and BMS will have the full right to exploit such BMS Study Inventions and BMS Study Patent Rights without the consent of, or any obligation to account to, the Recipient. The Recipient shall assign and hereby assigns (and shall cause its Affiliates and contractors to assign) all its right, title and interest in any BMS Study Inventions and BMS Study Patent Rights to BMS. The Recipient shall execute such further documents and provide other assistance as may be reasonably requested by BMS to perfect BMS’s rights in such BMS Study Inventions and BMS Study Patent Rights, all at BMS’s expense. BMS shall have the sole right but not the obligation to Prosecute and maintain any BMS Study Patent Rights at its own expense.

(i) All Combined Therapy Inventions and Combined Therapy Patent Rights shall be jointly owned by the Parties, with each Party having an undivided one-half interest in all Combined Therapy Inventions and Combined Therapy Patent Rights, and each Party shall have the right to freely exploit, within the Territory, the Combined Therapy Inventions and Combined Therapy Patent Rights, both within and outside the scope of this Agreement, without the consent of, or accounting or any other obligation to, the other Party (except as expressly set forth in this Section 6.1(c) and Section 6.1(d) with regard to the Prosecution, maintenance and enforcement of Combined Therapy Patent Rights) and each Party may use, exploit and grant licenses (with right to sublicense), for use and exploitation in the Territory, to Third Parties under its interests in such Combined Therapy Inventions and Combined Therapy Patent Rights.

(ii) Recipient, [***], shall have the sole rights and responsibility (except as otherwise provided below), and at its sole discretion, for Prosecuting patent applications, and maintaining issued Patents, within

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the Territory that Cover inventions within the Combined Therapy Patent Rights. The Recipient shall keep BMS reasonably advised as to material developments and steps to be taken with respect to its Prosecuting any such Patent Rights and shall furnish BMS with copies of applications for such Combined Therapy Patent Rights, amendments thereto and other related material correspondence to and from patent offices, and permit BMS a reasonable opportunity to review and offer comments prior to submitting such applications and material correspondence to the applicable governmental authority (and will take BMS’s comments into account in preparing same). BMS shall reasonably assist and cooperate in Prosecuting and maintaining the Combined Therapy Patent Rights. Notwithstanding the foregoing, the Recipient shall not knowingly take any position in a submission to a patent office concerning a patent application for a Combined Therapy Patent Right that interprets the scope of a claim in a BMS Independent Patent Right or BMS Study Patent Right without the prior written consent of BMS, such consent not to be unreasonably withheld. The Recipient shall be reimbursed by BMS for [***]% of any costs and expenses incurred in Prosecuting Combined Therapy Patent Rights and the subsequent maintenance of Combined Therapy Patent Rights, such that BMS shall be responsible for [***] percent ([***]%) of all such costs and expenses. From time-to-time, the Recipient shall invoice BMS for [***]% of the amounts of such costs and expenses incurred, and BMS shall pay the Recipient such invoiced amounts within [***] after receipt of an invoice therefor.

(iii) The Parties shall discuss in good faith the countries in which the Combined Therapy Patent Rights will be filed, and whether and on what terms BMS shall take the lead in Prosecuting any particular Combined Therapy Patent Rights in particular countries. In the event Recipient decides not Prosecute (or continue Prosecution of) a particular Combined Therapy Patent Right in a given country, then Recipient shall give BMS written notice of such decision, and in such case BMS shall have the right (but not obligation) to Prosecute and maintain such Combined Therapy Patent Right in such country in its own name and at its own expense. In this case, Recipient shall promptly assign its rights to such Combined Therapy Patent Right in said country to BMS solely in such country, and BMS shall grant, and hereby grants, to Recipient an irrevocable, perpetual, fully-paid, non-exclusive license, with the right to grant and authorize sublicenses, under such Combined Therapy Patent Rights to make, have made, use, sell, offer for sale, import and other exploit products and services in such country (which license shall survive any expiration or termination of this Agreement), provided Recipient has reimbursed BMS for [***]% of BMS’ Prosecution costs and expenses incurred under this subsection (iii). In such case, Recipient shall provide BMS reasonable assistance in BMS’ Prosecution (at BMS’ expense) of such assigned Combined Therapy Patent Right in such country, including the timely provision of all documents in Recipient’s possession required under national provisions to register said assignment of rights with the corresponding national authorities [***]. If BMS decides not to, or does not, reimburse Recipient for [***]% of Recipient’s Prosecution costs and expenses incurred under subsection (iii) above as to a particular Combined Therapy Patent Right in a country, then BMS shall, on Recipient’s written request, promptly assign all its rights to such Combined Therapy Patent Right in said country to Recipient.

(d) Separation of Patent Rights. In order to more efficiently enable the Prosecution and maintenance of the BMS Study Patent Rights, the Recipient Study Patent Rights, and the Combined Therapy Patent Rights relating to applicable Study Inventions as provided and described above, the Parties will use good faith efforts to separate BMS Study Patent Rights, the Recipient Study Patent Rights, Combined Therapy Patent Rights, BMS Independent Patent Rights and the Recipient Independent Patent Rights into separate patent filings to the extent reasonably possible and without adversely impacting such Prosecution and maintenance or the scope of the protected patentable subject matter.

6.2 Disclosure and Assignment of Inventions. Each Party shall disclose promptly to the other Party in writing and on a confidential basis all Study Inventions prior to any public disclosure thereof or filing of Patent Rights therefor and allowing sufficient time for comment by the other Party. In addition,

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each Party shall, and does hereby, assign, and shall cause its Affiliates and contractors to so assign, to the other Party, without additional compensation, such right, title and interest in and to any Inventions as well as any Patent Rights and other intellectual property rights with respect thereto, as is necessary to fully effect, as applicable, the sole ownership provided for in Sections 6.1(a) and 6.1(b) and the joint ownership provided for in Section 6.1(c).

6.3 Infringement of Patent Rights by Third Parties.

(a) Notice. Each Party shall promptly notify the other Party in writing of any Infringement of Combined Therapy Patent Rights, of which it becomes aware.

(b) Infringement of Recipient Patent Rights. For all Infringements of Recipient Study Patent Rights or Recipient Independent Patent Rights anywhere in the world, Recipient shall have the exclusive right to enforce its Patent Rights against such Infringements as it may determine in its sole and absolute discretion (including settling any such enforcements), and the Recipient shall bear all related expenses and retain all related recoveries. BMS shall reasonably cooperate with the Recipient or its designee (to the extent BMS has relevant information arising out of this Agreement), at the Recipient’s request and expense, in any such action to enforce such Patent Rights.

(c) Infringement of BMS Patent Rights. For all Infringements of BMS Study Patent Rights or BMS Independent Patent Rights anywhere in the world, BMS shall have the exclusive right to enforce its Patent Rights against such Infringements as it may determine in its sole and absolute discretion (including settling any such enforcements), and BMS shall bear all related expenses and retain all related recoveries. The Recipient shall reasonably cooperate with BMS or its designee (to the extent that the Recipient has relevant information arising out of this Agreement), at BMS’s request and expense, in any such action to enforce such Patent Rights.

(d) Infringement of Combined Therapy Patent Rights .

(i) With respect to Infringements of Combined Therapy Patent Rights, the Parties shall discuss reasonably and mutually agree as to whether to bring an enforcement action to seek the removal or prevention of such Infringements and damages therefor and, if so, which Party shall bring such action, with any costs and expenses relating thereto to be allocated in accordance with Section 6.3(d)(ii).

(ii) Regardless of which Party brings an enforcement action pursuant to Section 6.3(d)(i) or whether the Parties reach agreement to initiate such an enforcement action, the other Party hereby agrees to cooperate reasonably in any such action, including, if required, by bringing a legal action, furnishing a power of attorney or joining as a plaintiff to such a legal action. If the Parties mutually agree to bring an enforcement action, BMS shall be responsible for [***] percent ([***]%), and the Recipient shall be responsible for [***] percent ([***]%) (or as the Parties otherwise agree in writing), of the reasonable and verifiable external costs and expenses incurred in connection with any such action. If either Party recovers monetary damages from any Third Party in an enforcement action agreed to by the Parties, such recovery shall be allocated first to the reimbursement of any actual, unreimbursed external costs and expenses incurred by either of the Parties in such litigation pro rata in accordance with the aggregate amounts spent by both Parties, and any remaining amounts shall be split [***] percent ([***]%) to the Recipient and [***] percent ([***]%) to BMS, unless the Parties agree in writing to a different allocation. If the Parties do not agree to initiating such an enforcement action, then either Party may initiate such action, under the following terms: (A) the Party initiating such enforcement action shall be responsible for the costs and expenses incurred in connection with such action and shall reimburse the other Party for the costs the other Party incurs for the assistance and cooperation requested by such Party and (B) [***].

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Neither Party shall enter into any settlement of any enforcement action under this Section 6.3(d) without the prior written consent of the other Party, such consent not to be unreasonably withheld.

6.4 Infringement of Third Party Rights.

(a) Notice. If activities conducted by a Party relating to the Combined Therapy Clinical Trial or otherwise pursuant to this Agreement become the subject of a claim of infringement or misappropriation of a patent, copyright or other proprietary right by a Third Party ( “ 3 ^rd Party Infringement Claim ” ) anywhere in the world against a Party, the Party first having notice of the claim shall promptly notify the other Party and, without regard to which Party is charged with said infringement and the venue of such claim, the Parties shall promptly confer to discuss the claim.

(b) Defense. If both Parties are charged with infringement pursuant to a 3rd Party Infringement Claim described in Section 6.4(a), each Party shall have the right to defend itself against such claim, and the Parties shall discuss in good faith defending such claim jointly. If only one Party is charged with infringement in such 3rd Party Infringement Claim, such Party will have the first right but not the obligation to defend such claim. If the charged Party does not commence actions to defend such claim within [***] after request by the other Party to do so, then the other Party shall have the right, but not the obligation, to defend any such claim to the extent such claim pertains to the other Party’s Single Agent Compound. In any event, the non-defending Party shall reasonably cooperate with the Party conducting the defense of the 3rd Party Infringement Claim and shall have the right to participate with separate counsel at its own expense (but solely with respect to its interests, and shall not interfere with the defending Party’s defense of the claim), and the defending Party shall consider comments and suggestions on strategy for defending the action by the non-defending Party in good faith. The Party defending the claim shall bear the cost and expenses of the defense of any such Third Party infringement claim and [***]. If the Parties jointly defend the claim, the Recipient shall bear [***] percent ([***]%), and BMS shall bear [***] percent ([***]%) of any external costs and expenses of the defense of any such Third Party infringement claim; provided, however, that, notwithstanding the foregoing, if the claim relates solely to one Party’s Compound, such Party will bear [***] percent ([***]%) of the costs and expenses of the defense of such claim and shall have the sole right, but not the obligation, to defend, settle and otherwise handle the disposition of such claim. Neither Party shall enter into any settlement of any such Third Party infringement action under this Section 6.4 concerning activities under this Agreement or the Combined Therapy that materially negatively affects the other Party’s rights under this Agreement or imposes any material obligations on the other Party, including any admissions of wrongdoing on behalf of the other Party, without such other Party’s prior written consent, not to be unreasonably withheld or delayed, except that a Party may settle any claim that solely relates to its Single Agent Compound without the consent of the other Party as long as such other Party’s rights under this Agreement are not materially adversely impacted (and in the case such a settlement would materially adversely affect the other Party’s rights under this Agreement, such settlement cannot be entered into, unless the Party obtains such other Party’s prior written consent, not to be unreasonably withheld or delayed).

6.5 Combined Therapy Clinical Trial Regulatory Documentation. Subject to the license and other rights granted by each Party to the other Party pursuant to this Agreement, the Recipient shall solely own all right, title and interest in and to the Combined Therapy Clinical Trial Regulatory Documentation; provided , however , that for clarity, BMS shall retain sole and exclusive ownership of any BMS Regulatory Documentation that is submitted with or referenced in the Combined Therapy Clinical Trial Regulatory Documentation and that the Recipient shall retain sole and exclusive ownership of any Recipient Regulatory Documentation that is submitted with or referenced in the Combined Therapy Clinical Trial Regulatory Documentation. This Section 6.5 is without limitation of any other disclosure obligations under this Agreement.

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6.6 No Other Use. Except as expressly provided or permitted in Section 6.1, the Recipient agrees not to apply for any Patent Rights based on or containing BMS Confidential Information, and to give no assistance to any Third Party for such application without BMS’s prior written authorization, and BMS agrees not to apply for any Patent Rights based on or containing the Recipient’s Confidential Information, and to give no assistance to any Third Party for such application without the Recipient’s prior written authorization.

6.7 Joint Research Agreement. The Parties acknowledge and agree that this Agreement is a “joint research agreement” as defined in 35 USC § 100 (h).

ARTICLE 7

COSTS AND EXPENSES

7.1 Manufacturing and IP Costs . Expenses incurred as described in Article 4 (regarding Manufacturing and Supply) and Article 6 (regarding Intellectual Property) shall be borne or shared by the Parties as provided in such Articles.

7.2 Third Party Study Costs . For all expenses ( other than those set forth in Section 7.1) that are directly attributable or reasonably allocable to the conduct of the Combined Therapy Clinical Trial: (a) the Recipient will solely bear all out-of-pocket costs reasonably incurred by the Recipient (or by BMS pursuant to the following sentence) to Third Parties (including to CROs, laboratories, investigators, and clinical sites/IRBs) in connection with the performance of the Combined Therapy Clinical Trial (“ Third Party Study Costs ”), and (b) each Party shall be solely responsible for all of its own internal costs (including costs of individual independent contractors) incurred by such Party or any of its Affiliates. It is not expected that BMS will incur any Third Party Study Costs; however, in the event BMS should incur any Third Party Study Costs in connection with the conduct of the Combined Therapy Clinical Trial, the Recipient will reimburse BMS for same, on a [***] basis within [***] following submission of an invoice therefor and appropriate supporting documentation, but solely to the extent BMS has provided Recipient an opportunity to confirm the legitimacy of such costs.

7.3 Third Party License Payments . If the conduct of the Combined Therapy Clinical Trial requires a Third Party License Payment, then the Party required to make such payment shall be responsible for same.

ARTICLE 8

RECORDS AND STUDY DATA

8.1 Records. Each Party shall maintain complete and accurate records of all work conducted with respect to the Combined Therapy Clinical Trial and of all Study Inventions and Study Data made, discovered or generated by or on behalf of such Party or its Affiliate, or by the Parties together, in the course of such Party’s (ies’) efforts with respect to the Combined Therapy Clinical Trial. Such records shall fully and properly reflect all work done and results achieved in the performance of the Combined Therapy Clinical Trial in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes.

8.2 Ownership of Study Data. As between BMS and Recipient, (a) BMS shall own the particular Study Data that relate exclusively to the BMS Study Drug (“ BMS Study Data ”), and the Recipient shall own the particular Study Data that relate exclusively to the Recipient Study Drug (“ Recipient Study Data ”), and (b) both Parties shall jointly own any and all Study Data that is not Recipient Study Data or the BMS Study Data (“ Combined Therapy Study Data ”). Each Party shall, and does hereby,

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assign, and shall cause its Affiliates to so assign, to the other Party, without additional compensation, its right, title and interest in and to any Study Data as is necessary to fully effect the foregoing, and agrees to execute all instruments as may be reasonably necessary to effect same.

8.3 Use of Study Data.

(a) Use of a Party’s Own Study Data. BMS may use and analyze the BMS Study Data for any purpose without obligation or accounting to the Recipient, who shall hold the BMS Study Data in confidence pursuant to this Agreement. The Recipient may use and analyze the Recipient Study Data for any purpose without obligation or accounting to BMS, who shall hold the Recipient Study Data in confidence pursuant to this Agreement.

(b) Use of Combined Therapy Study Data by BMS. As between BMS and Recipient, BMS, [***] shall have the right to: (A) use, analyze and exploit the Combined Therapy Study Data in connection with the independent development, commercialization or other exploitation of the BMS Study Drug (alone or in combination with other drugs and/or other pharmaceutical agents) in the Territory, and (B) analyze the safety information within the Combined Therapy Study Data in connection with the independent development, commercialization or other exploitation of the BMS Study Drug (alone or in combination with other drugs and/or other pharmaceutical agents other than Recipient Study Drug) outside the Territory, and include such safety information in the safety database for the BMS Study Drug for use outside the Territory, in each case (A) or (B) above without the consent of, or any obligation to account to, the Recipient; provided that nothing in any case (A) or (B) above shall grant, or is intended or shall be construed as granting, BMS [***] any right or license, expressly or impliedly, to make, have made, use, sell, offer for sale, or import the Recipient Study Drug or a Recipient Class Drug within or outside the Territory. Subject to Section 8.5, the results of all such analyses or uses shall be owned by BMS, including any intellectual property arising out of same, unless the Parties shall have agreed otherwise in a writing separate from this Agreement. Subject to Applicable Law, BMS agrees that it (and its Affiliates and (sub)licensees, including [***]) will not use or exploit the Combined Therapy Study Data for itself or in collaboration with a Third Party for any purpose outside the Territory except as provided in Section 8.3(b) above.

(c) Use of Combined Therapy Study Data by the Recipient. As between Recipient and BMS, Recipient, [***] shall have the right to: (A) use, analyze and exploit the Combined Therapy Study Data in connection with the independent development, commercialization or other exploitation of the Recipient Study Drug (alone or in combination with other drugs and/or other pharmaceutical agents other than BMS Study Drug) in the Territory, and (B) analyze the safety information within the Combined Therapy Study Data in connection with the independent development, commercialization or other exploitation of the Recipient Study Drug (alone or in combination with other drugs and/or other pharmaceutical agents) outside the Territory, and include such safety information in the safety database for the Recipient Study Drug for use outside the Territory, in each case (A) and (B) above without the consent of, or any obligation to account to, BMS; provided that nothing in any case (A) or (B) above shall grant, or is intended or shall be construed as granting, Recipient [***], any right or license, expressly or impliedly, to make, have made, use, sell, offer for sale, or import the BMS Study Drug within or outside the Territory. Subject to Section 8.5, the results of all such analyses or uses shall be owned by the Recipient, including any intellectual property arising out of same, unless the Parties shall have agreed otherwise in a writing separate from this Agreement. Subject to Applicable Law, Recipient agrees that it (and its Affiliates and (sub)licensees, including [***]) will not use or exploit the Combined Therapy Study Data for itself or in collaboration with a Third Party for any purpose outside the Territory except as provided in Section 8.3(c) above.

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(d) Biomarker/Dx Agent Development. Each Party may use, [***], the Combined Therapy Study Data and the Study Data that relate exclusively to its Compound, to develop and commercialize a biomarker or diagnostic test for use with its Compound and/or the Combined Therapy. Unless otherwise mutually agreed by the Parties in writing, [***], each Party will own any intellectual property and data arising out of the work funded or conducted by it, by itself [***], and if requested by the other Party, it shall [***] grant to the other Party a worldwide, perpetual, irrevocable, fully paid-up, royalty-free, non-exclusive license, with the right to grant and authorize sublicenses, under such intellectual property and data that relates directly to such a biomarker or diagnostic test, solely to develop and commercialize biomarkers and/or diagnostic tests for use with such other Party’s Compound and/or the Combined Therapy, such license to be on commercially reasonable terms to be agreed by the Parties. [***].

(e) No Other Uses. All uses of Combined Therapy Study Data are limited solely to those permitted by this Agreement, and neither Party may use Combined Therapy Study Data for any other purpose without the consent of the other Party during and after the Term, such consent not to be unreasonably withheld.

8.4 Access to Study Data. Subject to the provisions of Sections 8.1, each Party shall have access to all Study Data (including de-identified patient records), and as and to the extent allowed in [***], the study protocol and applicable regulations. The Recipient shall make such Study Data in its possession available to BMS within a reasonable period of time, but not to exceed [***] after the [***] in which such Study Data is available to the Recipient.

8.5 Samples.

(a) All Samples shall be owned by the Recipient (to the extent not owned by the patient and/or the clinical trial site). Any such Samples shall be collected in accordance with the Protocol and applicable ICFs. Except as set forth in the Protocol, or as expressly permitted by this Agreement or the applicable ICF, Recipient shall not be permitted to use such Samples for any purpose without the prior written consent of BMS, which consent shall not be unreasonably withheld if such use is directed to the Combined Therapy and with the terms of such use to be set forth in a written agreement between the Parties setting forth the Samples to be used, and any appropriate terms/restrictions on such use. Except for intellectual property pertaining to the [***] Assay (which shall be owned by BMS), any data and intellectual property arising out of such Sample use shall be owned by Recipient; provided that, to the extent that any such data or intellectual property relates solely to the Combined Therapy (or biomarkers solely for use with the Combined Therapy), shall be considered Combined Therapy Study Data, Combined Therapy Inventions and/or Combined Therapy Patent Rights, as the case may be. Samples will be stored for future use in the Recipient’s sample repository. If BMS desires that certain tests be performed on such Samples, BMS shall communicate the same to Recipient in writing, and provided that sufficient quantities of Samples are available and subject to the terms of the applicable ICF and Applicable Law, Recipient shall use reasonable efforts to conduct, or have conducted, such tests on such Samples and, to the extent that such tests are performed, Recipient shall promptly provide a copy of the results thereof to BMS. If the Parties agree that they no longer have a use for the Samples, then the remaining Samples will be destroyed pursuant to Recipient’s standard operating procedures for sample retention and destruction, subject to the terms of and permission(s) granted in the informed consent forms signed by the subjects contributing the Samples in the Combined

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Therapy Clinical Trial.

(b) If Recipient and BMS so agree, and provided that sufficient quantities of Samples are available and subject to the terms of the applicable ICF and Applicable Law, BMS will arrange for the Recipient to use BMS’s preferred Third Party vendor(s), at the Recipient’s expense, for bioanalytical work of Samples from Combined Therapy Clinical Trial subjects on the BMS Study Drug. Such vendor(s) will provide the results of their bioanalytical work of such Samples to the Recipient and BMS, which results will be included in the final clinical study report, along with the bioanalytical work of the Recipient Study Drug and BMS Study Drug performed by or on behalf of the Recipient. For the avoidance of doubt, all such bioanalytical results for the BMS Study Drug and the Recipient Study Drug are deemed Study Data. As between BMS and Recipient, all data derived pursuant to work conducted pursuant to the Protocol on such Samples is deemed Study Data.

ARTICLE 9

CONFIDENTIALITY

9.1 Nondisclosure of Confidential Information.

(a) Prior to the Effective Date, the Recipient and BMS entered into a certain Mutual Confidential Disclosure Agreement dated [***] (the “ CDA ”). As it relates to disclosures involving the BMS Study Drug, the Recipient Study Drug or the Combined Therapy with respect to conduct of the Combined Therapy Clinical Trial (including plans for such study or its conduct) only, the CDA is hereby superseded and replaced by the terms of this Agreement, and any Confidential Information relating to or for the purpose of conducting the Combined Therapy Clinical Trial disclosed by either Party to the other Party shall be Confidential Information (of the disclosing Party) subject to the terms of this Agreement, and each of the Parties shall treat all such Confidential Information as such in accordance with the terms hereof. All written, visual, oral and electronic data, information, know-how or other proprietary information or materials, both technical and non-technical, disclosed by one Party to any other Party pursuant to this Agreement, or prior to the Effective Date and relating to matters contemplated by this agreement, and disclosed hereunder, shall be “ Confidential Information ” of the disclosing Party. All Study Data and Study Inventions shall be the Confidential Information of the Party owning such Study Data or Study Invention (as provided in Section 8.2 with regard to Study Data and Section 6.1 with regard to Study Inventions). For purposes of this Agreement, regardless of which Party discloses such Confidential Information to the other, (i) all Recipient Study Inventions, Recipient Technology and Recipient Regulatory Documentation shall be Confidential Information of the Recipient, and BMS shall be deemed the receiving Party with respect thereto, and (ii) all BMS Study Inventions, BMS Technology, and BMS Regulatory Documentation shall be Confidential Information of BMS, and the Recipient shall be deemed the receiving Party with respect thereto.

(b) The Parties agree that the terms of this Agreement shall be treated as Confidential Information of each of the Parties, and thus may be disclosed only as permitted by Section 9.3. Except as required by Applicable Law, each Party agrees not to issue any press release or public statement disclosing information relating to this Agreement or the transactions contemplated hereby or the terms hereof without the prior written consent of the other Party (such consent not to be unreasonably withheld), except as permitted by Sections 9.3 and 9.5(b).

(c) Except to the extent expressly authorized in this Section 9.1 and Sections 9.2, 9.3 and 9.5 below, or as otherwise agreed in writing by the Parties, each Party agrees that, for the Term and for a period of [***] thereafter, it shall (A) keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as expressly provided for in this Agreement any

[***] = Certain Confidential Information Omitted

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Confidential Information of the other Party (including information relating to this Agreement or the transactions contemplated hereby or the terms hereof), (B) treat the other Party’s Confidential Information with the same degree of care the receiving Party uses for its own confidential information but in no event with less than a reasonable degree of care; and (C) reproduce the disclosing Party’s Confidential Information solely to the extent reasonably needed to accomplish the receiving Party’s obligations under this Agreement or exercise the receiving Party’s rights to use and disclose such Confidential Information as expressly provided for in this Agreement, with all such reproductions being considered the disclosing Party’s Confidential Information, provided that , with respect to BMS Confidential Information that was received as confidential information from Ono, the obligations of confidentiality and nonuse shall continue until BMS has obtained Ono’s written consent that the same may be freely used, and with respect to Recipient Confidential Information that was received as confidential information from BeiGene, the obligations of confidentiality and nonuse shall continue until Recipient has obtained BeiGene’s written consent that the same may be freely used. Notwithstanding anything to the contrary in this Section 9.1, the receiving Party may disclose the disclosing Party’s Confidential Information to its employees, consultants, agents or permitted (sub)licensees solely on a need-to-know basis for the purpose of fulfilling the receiving Party’s obligations under this Agreement and exercising the receiving Party’s rights to use and disclose such Confidential Information as expressly provided for in this Agreement; provided, however, that (1) any such employees, consultants, agents or permitted (sub)licensees are bound by obligations of confidentiality and non-use at least as restrictive as those set forth in this Agreement, and (2) the receiving Party remains liable for the compliance of such employees, consultants, agents or permitted (sub)licensees with such obligations.

(d) Each receiving Party acknowledges that in connection with its and its representatives examination of the Confidential Information of the disclosing Party, the receiving Party and its representatives may have access to material, non-public information, and that the receiving Party is aware, and will advise its representatives who are informed as to the matters that are the subject of this Agreement, that State and Federal laws, including United States securities laws, may impose restrictions on the dissemination of such information and trading in securities when in possession of such information. Each receiving Party agrees that it will not, and will advise its representatives who are informed as to the matters that are the subject of this Agreement to not, purchase or sell any security of the disclosing Party on the basis of the Confidential Information of the disclosing Party to the extent such Confidential Information constitute material nonpublic information about the disclosing Party or such security.

(e) Combined Therapy Study Data shall be treated as Confidential Information of each Party and shall not be disclosed to Third Parties except to the extent: (i) it falls within the exceptions set forth in Section 9.2 below, (ii) is authorized under this Section 9.1 or Section 9.3 to be disclosed, (iii) is required to be filed with a Regulatory Authority or included in a product’s label or package insert, (iv) is reasonably necessary to be disclosed in order for a Party to exercise its rights under Section 8.3(b) or 8.3(c), or (v) is disclosed pursuant to Section 9.5.

9.2 Exceptions. The obligations in Section 9.1 shall not apply with respect to any specific portion of Confidential Information that the receiving Party can demonstrate by contemporaneous tangible records or other competent proof:

(a) was already known to the receiving Party (or its Affiliates), other than under an obligation of confidentiality, either (i) at the time of disclosure by the disclosing Party, or (ii) if applicable, at the time that it was generated hereunder, whichever ((i) or (ii)) is earlier;

(b) was generally available to the public or otherwise part of the public domain either (i) at the time of its disclosure to the receiving Party, or (ii) if applicable, at the time that it was generated hereunder, whichever ((i) or (ii)) is earlier;

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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) was disclosed to the receiving Party (or its Affiliates), other than under an obligation of confidentiality, by a Third Party who had no obligation to the Party owning or Controlling the information not to disclose such information to others; or

(e) was independently discovered or developed by the receiving Party (or its Affiliates) without the use of, or reference to, the Confidential Information of the disclosing Party.

9.3 Authorized Disclosure. Notwithstanding any other provision of this Agreement, each Party may disclose particular Confidential Information of the other Party to the extent such disclosure is reasonably necessary in the following instances:

(a) filing or prosecuting Patent Rights pursuant to Section 6.1(c);

(b) prosecuting or defending litigation;

(c) complying with Applicable Law or the rules or regulations of any securities exchange on which such Party’s stock is listed;

(d) disclosure, in connection with the performance of this Agreement, to [***] each of whom prior to disclosure must be bound by terms of confidentiality and non-use at least as protective of Confidential Information as those set forth in this Article 9;

(e) disclosure of the Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patent Rights to Regulatory Authorities in connection with the development of the Combined Therapy, the Recipient Study Drug or the BMS Study Drug;

(f) disclosure of relevant safety information contained within the Combined Therapy Study Data to investigators, IRBs and/or ethics committees and Regulatory Authorities that are involved in other clinical trials of the Recipient Study Drug with respect to the Recipient, and the BMS Study Drug with respect to BMS, and, in the event of a Material Safety Issue, to Third Parties that are collaborating with the Recipient or BMS, respectively in the conduct of such other clinical trials of the Recipient Study Drug or the BMS Study Drug, in each case solely to the extent necessary for the conduct of such clinical trials and/or to comply with Applicable Law and regulatory requirements; and

(g) disclosure of Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patent Rights, and the terms of this Agreement, to [***], and provided that such recipients must be bound by terms of confidentiality and non-use at least as protective of Confidential Information as those set forth in this Article 9.

Notwithstanding the foregoing, if a Party is required or otherwise intends to make a disclosure of any other Party’s Confidential Information pursuant to Section 9.3(b) and/or Section 9.3(c), it shall give advance notice to such other Party of such impending disclosure and endeavor in good faith to secure confidential treatment of such Confidential Information and/or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment.

[***] = Certain Confidential Information Omitted

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9.4 Disclosure to [***]; Disclosure to [***]. [***] .

9.5 Press Releases and Publications.

(a) The Parties shall jointly agree (such agreement not to be unreasonably withheld by either Party) to the content and timing of all public communications with respect to this Agreement (except for the initial press release announcing this Agreement a draft of which is attached hereto as Appendix C), subsequent press releases, Q&As, and the content of, and wording for, any listing the Combined Therapy Clinical Trial required to be listed on a public database or other public registry (such as www.clinicaltrials.gov). For clarity, if either Party terminates this Agreement pursuant to Section 12.4, the Parties shall mutually agree upon any external communication related to such termination, which shall not include the rationale for such termination unless (and to the extent) mutually agreed by the Parties; provided that either Party shall be permitted to publicly disclose information that such Party determines in good faith is necessary to be disclosed to comply with Applicable Law or the rules or regulations of any securities exchange on which such Party’s stock may be listed, or pursuant to an order of a court or governmental entity.

(b) The Recipient and BMS agree to collaborate reasonably and in good faith to publicly disclose, publish or present (i) top-line results from the Combined Therapy Clinical Trial, limited if possible to avoid jeopardizing the future publication of the Study Data at a scientific conference or in a scientific journal, solely for the purpose of disclosing, as soon as reasonably practicable, the safety or efficacy results and conclusions that are material to either Party under applicable securities laws, and (ii) the conclusions and outcomes of the Combined Therapy Clinical Trial (the “ Results ”), as set forth in the Final Study Report, at a scientific conference as soon as reasonably practicable following the completion of such Combined Therapy Clinical Trial, subject in the case of (ii) to the following terms and conditions. The Party proposing to disclose, publish or present the Results or any of the Combined Therapy Study Data shall deliver to the other Party a copy of the proposed disclosure, publication or presentation at least [***] before submission to a Third Party. The reviewing Party shall determine whether any of its Confidential Information that is contained in such proposed disclosure, publication or presentation should be modified or deleted, whether to file a patent application on any Recipient Study Invention (solely with respect to the Recipient) or BMS Study Invention (solely with respect to BMS) or Combined Therapy Invention disclosed therein. The disclosure, publication or presentation shall be delayed for an additional [***] (i.e., a total of [***] from the initial proposal) if the reviewing Party reasonably requests such extension to allow time for the preparation and filing of relevant patent applications. If the reviewing Party reasonably requests modifications to the disclosure, publication or presentation to prevent the disclosure of Confidential Information of the reviewing Party (other than the

[***] = Certain Confidential Information Omitted

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Results or Combined Therapy Study Data), the publishing Party shall edit such publication to prevent the disclosure of such information prior to submission of the disclosure, publication or presentation. In the event of a disagreement as to content, timing and/or venue or forum for any disclosure, publication or presentation of the Results, such dispute (a “ Publication Dispute ”) shall be referred to the Executive Officers (or their respective designees); provided that, in the absence of agreement after such good faith discussions, and upon expiration of the additional [***]-period, (A) academic collaborators or Study Sites engaged by the Recipient in connection with the performance of the Combined Therapy Clinical Trial may publish Combined Therapy Study Data obtained by such academic collaborator or Study Site solely to the extent that such ability to publish such Combined Therapy Study Data is set forth in an agreement between the Recipient and such academic collaborator or Study Site relating to the conduct of Combined Therapy Clinical Trial and (B) the publishing Party may proceed with the disclosure, publication or presentation provided that such disclosure, publication or presentation is consistent with its internal publication guidelines and customary industry practices for the publication of similar data and does not disclose the Confidential Information of the other Party (other than the Results or Combined Therapy Study Data). Authorship of any publication shall be determined based on the accepted standards used in peer-reviewed academic journals at the time of the proposed disclosure, publication or presentation. The Parties agree that they shall make reasonable efforts to prevent publication of a press release that could jeopardize the future publication of Study Data at a scientific conference or in a scientific journal but in no way will this or any other provision of this Agreement supersede the requirements of any Applicable Law or the rules or regulations of any securities exchange or listing entity on which a Party’s stock is listed (including any such rule or regulation that may require a Party to make public disclosures about interim results of the Combined Therapy Clinical Trial). Notwithstanding the foregoing, nothing herein shall prevent or restrict: (i) [***], or (ii) [***] respectively, to comply with requirements of Applicable Law, the rules or regulations of any securities exchange or listing entity on which its stock may be traded or pursuant to an order of a court or governmental entity to publicly disclose the existence of the Agreement and the Study Data, provided that [***], BMS and Recipient, respectively, will each use reasonable efforts to ensure it will only disclose the minimum amount of information necessary to achieve compliance and to ensure that it will provide the Recipient or BMS, respectively, with reasonable advance notice of such disclosure and the reason for the disclosure requirement.

(c) The Recipient agrees to include in all press releases, presentations and publications it makes related to the Combined Therapy Clinical Trial specific mention, if applicable, of the BMS Study Drug and the support and involvement of BMS. BMS agrees to include in all press releases, presentations and publications it makes related to the Combined Therapy Clinical Trial specific mention, if applicable, of the Recipient Study Drug and the support and involvement of the Recipient.

9.6 Compliance with Sunshine Laws.

(a) As and when applicable, each Party (as the “Reporting Party”) will report payments or other transfers of value (“ POTV ”) made by such Party or its contractor(s) related to the conduct of the Combined Therapy Clinical Trial and any applicable associated contractor engagements as required under the Sunshine Laws for the Combined Therapy Clinical Trial. For purposes of compliance with reporting obligations under Sunshine Laws with respect to this Agreement, as between the Parties, Recipient represents that it is not, as of the Effective Date, a manufacturer of any drug or biological that is approved for marketing in the United States by the FDA and the Parties acknowledge that, accordingly, Recipient is not as of Effective Date subject to reporting obligations under the Sunshine Laws in the United States. The Parties acknowledge that, as between the Parties, BMS may be required to report POTV made by the Parties or their respective contractor(s) related to the conduct of the Combined Therapy Clinical

[***] = Certain Confidential Information Omitted

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Trial and any applicable associated contractor engagements as required under the Sunshine Laws for the Combined Therapy Clinical Trial. BMS shall request delayed publication for any reported POTV for studies sponsored by the Recipient as permitted under the Sunshine Laws and if consistent with BMS’s normal business practices. In the event that the Recipient becomes responsible for reporting POTV for studies sponsored by it in a given country during the Term, the Recipient shall provide written notification to BMS and the Parties will meet to confer to discuss how they wish to handle reporting thereafter. Interpretation of the Sunshine Laws for purposes of reporting any POTV by a Party shall be in such Party’s sole discretion so long as the interpretation complies with Applicable Law.

(b) The Recipient (i) will provide (to the extent in the possession of the Recipient), or will utilize Commercially Reasonable Efforts to obligate and ensure that each CRO and other applicable Third Party contractors for the Combined Therapy Clinical Trial provides, BMS with any information requested by BMS as BMS may reasonably determine is necessary for BMS to comply with its reporting obligations under Sunshine Laws (with such amounts paid to, or at the direction of, healthcare providers, teaching hospitals and/or any other persons for whom POTVs must be reported under Sunshine Laws to be reported to BMS within a reasonable time period specified by BMS), and (ii) will reasonably cooperate with, and will utilize Commercially Reasonable Efforts to obligate and ensure that each CRO and other applicable Third Party contractors for the Combined Therapy Clinical Trial reasonably cooperates with (i) above as and to the extent required for BMS to comply with such Sunshine Laws with respect to the Combined Therapy Clinical Trial. The form in which the Recipient provides any such information shall be mutually agreed but sufficient to enable BMS to comply with its reporting obligations and BMS may disclose any information that it believes is necessary to comply with Sunshine Laws. Without limiting the foregoing, BMS shall have the right to allocate POTVs in connection with this Agreement in any required reporting under Sunshine Laws in accordance with its normal business practices. These obligations shall survive the expiration and termination of this Agreement to the extent necessary for BMS to comply with Sunshine Laws. The Recipient shall not be required to provide any information to BMS that is subject to disclosure pursuant to the Recipient’s own obligations under the Sunshine Laws. BMS shall provide all cooperation and assistance reasonably requested by Recipient in connection with Recipient’s reporting of POTV under the Sunshine Laws as and when applicable to Recipient.

(c) For purposes of this Section 9.6, “ Sunshine Laws ” shall mean Applicable Laws requiring collection, reporting and disclosure of POTVs to certain healthcare providers, entities and individuals. These Applicable Laws may include relevant provisions of the Patient Protection and Affordable Care Act of 2010 and implementing regulations thereunder.

9.7 Destruction of Confidential Information. Upon expiration or termination of the Agreement, the receiving Party shall, upon request by the other Party, immediately destroy or return all of the other Party’s Confidential Information relating solely to the other Party’s Compound as monotherapy (but not to the Combined Therapy or the Combined Therapy Study Data) in its possession; provided , however , that the receiving Party shall be entitled to retain one (1) copy of Confidential Information solely for record-keeping purposes, or as needed to exercise its surviving rights under this Agreement, and shall not be required to destroy any Confidential Information required, or reasonably necessary, to be retained for any clinical trial activities that continue after expiration or termination, or off-site computer files created during automatic system back up which are subsequently stored securely by the receiving Party.

9.8 Nonsolicitation of Employees. Each Party agrees that, during the conduct of the Combined Therapy Clinical Trial and for [***] thereafter, neither it nor any of its Affiliates shall recruit, solicit or induce any employee of the other Party directly involved in the development or other activities conducted by the other Party under this Agreement to terminate his or her employment with such other Party and become employed by or consult for such other Party, whether or not such employee is a full‑time employee of such other Party, and whether or not such employment is pursuant to a written agreement or is at‑will. For purposes of the foregoing, “recruit”, “solicit” or “induce” shall not be deemed

[***] = Certain Confidential Information Omitted

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to mean (a) circumstances where an employee of one Party initiates contact with the other Party or any of its Affiliates with regard to possible employment, or (b) general solicitations of employment not specifically targeted at employees of a Party or any of its Affiliates, including responses to general advertisements.

ARTICLE 10

REPRESENTATIONS AND WARRANTIES

10.1 Authority and Binding Agreement. Each Party represents and warrants to the other Party as of the Effective Date that (a) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, (b) it has taken all necessary corporate action on its part required to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder, and (c) the 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 subject to bankruptcy, insolvency, reorganization, arrangement, winding-up, moratorium, and similar laws of general application affecting the enforcement of creditors’ rights generally, and subject to general equitable principles, including the fact that the availability of equitable remedies, such as injunctive relief or specific performance, is in the discretion of the court.

10.2 No Conflicts. Each Party represents and warrants to the other Party as of the Effective Date that, to the best of its knowledge, it has not entered, and shall not enter, into any agreement with any Third Party that is in conflict with the rights granted to the other Party under this Agreement, and has not taken any action that would in any way prevent it from granting the rights granted to the other Party under this Agreement, or that would otherwise materially conflict with the rights granted to the other Party under this Agreement.

10.3 Litigation. Each Party represents and warrants to the other Party as of the Effective Date that, to the best of its knowledge, it is not aware of any pending or threatened litigation (and has not received any written communication) that alleges that its activities related to this Agreement have violated, or that by conducting the activities as contemplated in this Agreement it would violate, any of the intellectual property rights of any other Person (after giving effect to the license grants in this Agreement).

10.4 No Adverse Proceedings. Each Party represents and warrants to the other Party as of the Effective Date that, except as otherwise notified to the other Party, there is not pending or, to the knowledge of such Party, threatened, against such Party, any claim, suit, action or governmental proceeding that would, if adversely determined, materially impair the ability of such Party to perform its obligations under this Agreement.

10.5 Consents. Each Party represents and warrants to the other Party as of the Effective Date that, to the best of its knowledge, all necessary consents, approvals and authorizations of all regulatory and governmental authorities and other Persons (a) required to be obtained by such Party in connection with the execution and delivery of this Agreement have been obtained and (b) required to be obtained by such Party in connection with the performance of its obligations under this Agreement have been obtained or will be obtained prior to such performance.

10.6 No Debarment. Each Party hereby certifies to the other that it has not used, and will not use the services of any person disqualified, debarred, banned, subject to debarment or convicted of a crime for which a person could be debarred by the FDA under 21 U.S.C. 335a, as amended (or subject to a similar sanction of any other Regulatory Authority), in any capacity in connection with any of the services or work provided under the Combined Therapy Clinical Trial and that this certification may be relied upon in any applications to the FDA or any other Regulatory Authority. It is understood and agreed that this certification

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imposes a continuing obligation upon each Party to notify the other promptly of any change in the truth of this certification. Upon request by a Party, the other Party agrees to provide a list of persons used to perform the services or work provided under any activities conducted for or on behalf of such Party or any of its Affiliates pursuant to this Agreement who, within the five (5) years preceding the Effective Date, or subsequent to the Effective Date, were or are convicted of one of the criminal offenses required by 21 U.S.C. 335a, as amended, to be listed in any application for approval of an abbreviated application for drug approval.

10.7 Compliance with Applicable Law. Each Party represents and warrants to the other Party that it shall comply with all Applicable Law of the country or other jurisdiction, or any court or agency thereof, applicable to the performance of its activities hereunder or any obligation or transaction hereunder, including those pertaining to the production and handling of drug products, such as those set forth by the Regulatory Authorities, as applicable, and the applicable terms of this Agreement in the performance of its obligations hereunder.

10.8 Affiliates. Each Party represents and warrants to the other Party that, to the extent the intellectual property, Regulatory Documentation or Technology licensed by it hereunder are Controlled by its Affiliates or a Third Party, it has the right to use, and has the right to grant (sub)licenses to the other Party to use, such intellectual property, Regulatory Documentation or Technology in accordance with the terms of this Agreement.

10.9 Ethical Business Practices. Each Party represents and warrants to the other Party that neither it nor its Affiliates will make any payment, either directly or indirectly, of money or other assets, including the compensation such Party derives from this Agreement (collectively a “ Payment ”), to government or political party officials, officials of International Public Organizations, candidates for public office, or representatives of other businesses or persons acting on behalf of any of the foregoing (collectively “ Officials ”) where such Payment would constitute violation of any law, including the Foreign Corrupt Practices Act of 1977, 15 U.S.C. §§ 78dd-1, et seq. In addition, regardless of legality, neither it nor its Affiliates will make any Payment either directly or indirectly to Officials if such Payment is for the purpose of improperly influencing decisions or actions with respect to the subject matter of this Agreement. All activities will be conducted in compliance with the U.S. False Claims Act and the U.S. Anti-Kickback Statute.

10.10 Single Agent Compound Safety Issues . Each Party represents and warrants as of the Effective Date that, to the best of its knowledge, it is not aware of any material safety or toxicity issue with respect to its Single Agent Compound that are not reflected in the investigator’s brochure for its Single Agent Compound existing as of the Effective Date.

10.11 Compliance with Licensor Agreements. Each Party will use, and will cause its Affiliates to use, Commercially Reasonable Efforts to comply with its obligations under any agreements entered into by it or its Affiliates with a Third Party under which it is licensed any intellectual property rights or confidential information relating to its Compound (and not to voluntarily terminate same) to the extent necessary for the Combined Therapy Clinical Trial to be conducted and completed in accordance with the terms of this Agreement and for the other Party to receive the rights and benefits provided to it under this Agreement.

10.12 BMS Drug Warranty. BMS represents and warrants that the BMS Study Drug manufactured and supplied hereunder shall, at the time of delivery: (a) comply with the specifications for such drug product (as set forth in the regulatory approvals for such product; (b) shall have been manufactured in accordance with all Applicable Laws; and (c) shall not be adulterated or misbranded as such terms are defined in accordance with Applicable Laws.

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10.13 DISCLAIMER OF WARRANTY. THE EXPRESS REPRESENTATIONS AND WARRANTIES STATED IN THIS ARTICLE 10 ARE IN LIEU OF, AND THE PARTIES DO HEREBY DISCLAIM, ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR USE, AND NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS.

ARTICLE 11

INDEMNIFICATION

11.1 BMS Indemnification. BMS hereby agrees to defend, hold harmless and indemnify (collectively, “ Indemnify ”) the Recipient, its Affiliates, and its and their agents, directors, officers, employees and subcontractors (the “ Recipient Indemnitees ”) from and against any and all liabilities, judgments, expenses and/or losses, including reasonable legal expenses and attorneys’ fees (collectively “ Losses ”) resulting from Third Party suits, claims, actions and demands (each, a “ Third Party Claim ”) against a Recipient Indemnitee to the extent that they arise or result from (a) the negligence or intentional misconduct of any BMS Indemnitee or any (sub)licensee of BMS (or its Affiliate) conducting activities on behalf of BMS (or its Affiliate) under this Agreement, (b) any breach by BMS of any provision of this Agreement, (c) any injury to a subject in the Combined Therapy Clinical Trial to the extent attributable to the BMS Study Drug, or (d) the use by BMS, its Affiliates, contractors or (sub)licensees of Combined Therapy Study Data, BMS Study Data, BMS Study Inventions, BMS Study Patent Rights, Combined Therapy Inventions and Combined Therapy Patent Rights; but excluding, in each case ((a) through (d)), any such Losses to the extent arising or resulting from a cause or event for which the Recipient is obligated to Indemnify the BMS Indemnitees pursuant to Section 11.2.

11.2 Recipient Indemnification. The Recipient hereby agrees to Indemnify BMS, its Affiliates, and its and their agents, directors, officers, employees and subcontractors (the “ BMS Indemnitees ”) from and against any and all Losses resulting from Third Party Claims against a BMS Indemnitee to the extent that they arise or result from (a) the negligence or intentional misconduct of any Recipient Indemnitee or any (sub)licensee of the Recipient conducting activities on behalf of the Recipient under this Agreement, (b) any breach by the Recipient of any provision of this Agreement, (c) any injury to a subject in the Combined Therapy Clinical Trial (other than injury to the extent attributable to the BMS Study Drug), or (d) the use by the Recipient, its Affiliates, contractors or (sub)licensees of Combined Therapy Study Data, Recipient Study Data, Recipient Study Inventions, Recipient Study Patent Rights, Combined Therapy Inventions and Combined Therapy Patent Rights; but excluding, in each case ((a) through (d)), any such Losses or Third Party Claims to the extent arising or resulting from a cause or event for which BMS is obligated to Indemnify the Recipient Indemnitees pursuant to Section 11.1.

11.3 Indemnification Procedure. Each Party’s agreement to Indemnify the other Party is conditioned on the performance of the following by the Party seeking indemnification: (a) providing written notice to the Indemnifying Party of any Loss and/or Third Party Claim of the types set forth in Section 11.1 and 11.2 promptly, and in any event within [***], after the Party seeking indemnification has knowledge of such Loss and/or Third Party Claim; provided that , any delay in complying with the requirements of this clause (a) will only limit the Indemnifying Party’s obligation to the extent of the prejudice caused to the Indemnifying Party by such delay, (b) permitting the Indemnifying Party to assume full responsibility to investigate, prepare for and defend against any such Loss and/or Third Party Claim, (c) providing reasonable assistance to the Indemnifying Party, at the Indemnifying Party’s expense, in the investigation of, preparation for and defense of any Loss and/or Third Party Claim, and (d) not compromising or settling such Loss and/or Third Party Claim without the Indemnifying Party’s written consent, such consent not to be unreasonably withheld or delayed.

[***] = Certain Confidential Information Omitted

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11.4 Separate Defense of Claims. In the event that the Parties cannot agree as to the application of Sections 11.1 and/or 11.2 to any particular Loss or Third Party Claims, the Parties may conduct separate defenses of such Loss and Third Party Claim. Each Party further reserves the right to claim indemnity from the other in accordance with Sections 11.1 and/or 11.2 upon resolution of the underlying Third Party Claim, notwithstanding the provisions of Section 11.3(b).

11.5 Insurance. Each Party shall maintain commercially reasonable levels of insurance or other adequate and commercially reasonable forms of protection or self-insurance to satisfy its indemnification obligations under this Agreement. Each Party shall provide the other Party with written notice at least [***] prior to the cancellation, non-renewal or material change in such insurance or self-insurance which would materially adversely affect the rights of the other Party hereunder. The maintenance of any insurance shall not constitute any limit or restriction on damages available to a Party under this Agreement.

11.6 LIMITATION OF LIABILITY. EXCEPT FOR DAMAGES AVAILABLE FOR BREACH OF THE CONFIDENTIALITY OR NON-USE OBLIGATIONS IN ARTICLE 9, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES, INCLUDING LOST PROFITS, ARISING FROM OR RELATING TO THIS AGREEMENT AND/OR SUCH PARTY’S PERFORMANCE HEREUNDER, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES AND REGARDLESS OF THE CAUSE OF ACTION (WHETHER IN CONTRACT, TORT, BREACH OF WARRANTY OR OTHERWISE). NOTHING IN THIS SECTION 11.6 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF A PARTY UNDER SECTIONS 11.1 OR 11.2.

ARTICLE 12

TERM AND TERMINATION

12.1 Term. This Agreement shall be effective as of the Effective Date and shall continue in effect until expiration upon the completion of the Combined Therapy Clinical Trial by all centers participating in the Combined Therapy Clinical Trial, delivery of all Study Data, including all completed case report forms, all final analyses and all final clinical study reports contemplated by the Combined Therapy Clinical Trial to both Parties, and the completion of any statistical analyses and bioanalyses contemplated by the Protocol or otherwise agreed to by the Parties to be conducted under this Agreement, or until earlier termination pursuant to Sections 12.2, 12.3 or 12.4 or any other termination right expressly stated in this Agreement (such period, the “ Term ”).

12.2 Termination for Material Breach.

(a) Notice and Cure Period. If a Party (the “ Breaching Party ”) is in material breach of its obligations under this Agreement, the other Party (the “ Non-Breaching Party ”) shall have the right to give the Breaching Party notice specifying in reasonable detail the nature of such material breach (a “ Breach Notice ”). The Breaching Party shall have a period of sixty (60) calendar days after receipt of such notice to cure such material breach (the “ Cure Period ”). For the avoidance of doubt, this provision is not intended to restrict in any way either Party’s right to notify the other Party of any other breach or to demand the cure of any other breach.

(b) Termination Right. If a Breach Notice is given, the Non-Breaching Party giving such notice shall have the right to terminate this Agreement (except as otherwise provided below in this subsection (b)), upon written notice to the other Party given no later than six (6) months after the end of the applicable Cure Period, in the event that the Breaching Party has not cured the material breach that is the

[***] = Certain Confidential Information Omitted

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subject of the Breach Notice within the Cure Period, provided, however, that if such breach is capable of cure but cannot be cured using reasonable diligent efforts within the Cure Period, and the Breaching Party commences actions to cure such material breach within the Cure Period and thereafter diligently continue such actions, the Breaching Party shall have an additional sixty (60) calendar days to cure such breach (and such sixty (60) day period shall be deemed added to the Cure Period in such case. If a Breach Notice is given, and the alleged Breaching Party contests that the alleged material breach happened, and or that the breach has not been cured within the Cure Period, pursuant to the dispute resolution procedures under Section 13.3, then any termination by the Non-Breaching Party pursuant to the above shall not be effective unless and until a conclusion of the dispute resolution procedures in Section 13.3, as applicable, that results in a determination that there has been a material breach that was not cured within the Cure Period (which Cure Period shall be tolled for the period from notice of such dispute until resolution of such dispute pursuant to Section 13.3 or abandonment of such dispute by the disputing Party).

12.3 Termination for Bankruptcy. A Party may terminate this Agreement if, at any time, the other Party shall file in any court or agency pursuant to any statute or regulation of any state, country or jurisdiction, a petition in bankruptcy or for the appointment of a receiver or trustee of such other Party or of such other Party’s assets, or if the other Party proposes a written agreement of composition or extension of its debts, or if the other Party shall be served with an involuntary petition against it, filed in any bankruptcy proceeding, and such petition shall not be dismissed or stayed within ninety (90) calendar days after the filing thereof, or if the other Party will propose or be a party to any dissolution or liquidation, or if the other Party shall make an assignment for the benefit of its creditors.

12.4 Termination due to Material Safety Issue; Clinical Hold; Study Termination.

(a) A Party shall have the right to terminate this Agreement immediately (but after meeting and discussing with the other Party in good faith as described in the following sentence) upon written notice if such Party reasonably deems it necessary in order to protect the safety, health or welfare of subjects enrolled in the Combined Therapy Clinical Trial due to the existence of a Material Safety Issue. In the event a Party believes that there is a Material Safety Issue and intends to effect a termination of the Agreement due to such Material Safety Issue, prior to such Party providing written notice of Termination, such Party shall give the other Party written notice of such Material Safety Issue and all material evidence for its belief of the existence thereof, and the members of each Party’s medical safety committee (or equivalent) and appropriate senior executives of each Party (with authority over the actions under this Agreement) shall, as soon as reasonably practicable, meet together and discuss in good faith the safety concerns raised by the Party and consider and discuss in good faith the input, questions and advice of the other Party. Should any dispute arise in such discussion, or should the Parties not agree on an appropriate resolution to the noticing Party’s safety concerns, the dispute resolution processes set forth in Section 13.3 shall not apply to such dispute or issues, and the noticing Party shall have the right, after conclusion of the meeting and discussions of the medical safety committees (or equivalent) and such executives, to issue a termination notice as provided above, and such termination of the Agreement shall take effect without the Parties first following the procedures set forth in Section 13.3.

(b) If a Clinical Hold with respect to either the BMS Study Drug or the Recipient Study Drug should arise at any time after the Effective Date, the Parties will meet and discuss the basis for the Clinical Hold, how long the Clinical Hold is expected to last, and how they might address the issue that caused the clinical hold. If, after ninety (90) days of discussions following the Clinical Hold, either Party reasonably concludes that the issue adversely impacts the Combined Therapy Clinical Trial and is not solvable or that unacceptable and material additional costs/delays have been and/or will continue to be incurred in the conduct of the Combined Therapy Clinical Trial, then such Party may immediately terminate this Agreement.

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BMS in the event that Recipient terminates the Combined Therapy Clinical Trial for any reason other than those described in Sections 12.4(a) or 12.4(b) above.

12.5 Effect of Termination. Upon expiration or termination of this Agreement, (a) the licenses granted in Sections 3.1 and 3.2 (and any sublicenses granted under Section 3.3) shall terminate except as otherwise expressly provided therein and further except as necessary to complete conduct of such Combined Therapy Clinical Trial as required under Applicable Law, and (b) the Parties shall use reasonable efforts to wind down activities under this Agreement in a reasonable manner and avoid incurring any additional expenditures or non-cancellable obligations; provided that , in the case of termination pursuant to Section 12.4, the Recipient may continue to dose subjects enrolled in the Combined Therapy Clinical Trial through completion of the Protocol if dosing is required by the applicable Regulatory Authority(ies) and/or Applicable Law. Any such wind-down activities will include the return to BMS, or destruction, of all BMS Study Drug provided to the Recipient and not consumed in the Combined Therapy Clinical Trial, except in the event that the Recipient terminates this Agreement pursuant to Section 12.2 or 12.3, in which case the Recipient shall continue to have the right to use any BMS Study Drug provided to Recipient for the conduct of the Combined Therapy Clinical Trial.

12.6 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. Provisions which by their terms expressly survive expiration or termination of this Agreement, along with the following Articles and Sections of this Agreement and all definitions relating thereto, shall survive any expiration or termination of this Agreement for any reason: Section 2.1(b), Section 2.4, Sections 3.1(b) and 3.2(b) (to the extent applicable to Rights of Cross-Reference and the clause (ii) licenses to market and promote), Section 4.5, Sections 5.1(e)-(h), Section 5.1(j), Section 5.1(k), Section 5.1(o), Article 6 (“ Intellectual Property ”), Article 7 (“ Costs and Expenses) , Article 8 (“ Records and Study Data ”), Article 9 (“ Confidentiality ”); Article 10 (“ Representations and Warranties ”), Article 11 (“ Indemnification ”), Section 12.5 (“ Effect of Termination ”), Section 12.6 (“ Survival ”), Section 13.1 (“ Entire Agreement ”), Section 13.2 (“ Governing Law ”), Section 13.3 (“ Dispute Resolution ”), Section 13.4 (“ Injunctive Relief ”), Section 13.6 (“ Notices ”), Section 13.7 (“ No Waiver, Modifications ”), Section 13.8 (“ No Strict Construction ”), Section 13.9 (“ Independent Contractor ”), Section 13.10 (“ Assignment, Licenses ”), Section 13.11 (“ Headings ”), Section 13.13 (“ Severability ”), Section 13.15 (“ No Benefit to Third Parties ”), and Section 13.16 (“ Construction ”).

ARTICLE 13

MISCELLANEOUS

13.1 Entire Agreement. The Parties acknowledge that this Agreement shall govern all activities of the Parties with respect to the Combined Therapy Clinical Trial from the Effective Date forward through the Term. This Agreement, including the Appendixes hereto, and together with the Supply and Quality Documentation, sets forth the complete, final and exclusive agreement between the Parties concerning the subject matter hereof and supersedes all prior agreements and understandings between the Parties with respect to such subject matter. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties with respect to such subject matter other than as are set forth in this Agreement. All Exhibits attached hereto are incorporated herein as part of this Agreement.

13.2 Governing Law. This Agreement shall be governed and construed in accordance with the internal laws of the State of New York, USA, excluding any choice of law rules that may direct the application of the laws of another jurisdiction.

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13.3 Dispute Resolution.

(a) The Parties’ [***] shall attempt in good faith to resolve any dispute or concern that either Party may bring to the other Party’s attention.

(b) In the event of any dispute, controversy, issue or claim arises between the Parties out of, relating to or in connection with any provision of this Agreement (each a “ Dispute ”), other than [***], then upon the request of either Party by written notice, the Parties shall refer such Dispute to the Executive Officers for discussion to seek to resolve the Dispute. This Agreement shall remain in effect during the pendency of any such Dispute and any discussions to resolve the Dispute and any dispute resolution actions under this Section 13.3. In the event that no resolution is made by the Executive Officers (or their designee) in good faith negotiations within [***] after such Dispute is referred to them, then (whether or not the Executive Officers actually engaged in discussions of the Dispute):

(i) if such Dispute constitutes an Arbitration Matter, such Dispute shall be resolved through arbitration in accordance with the remainder of this Section 13.3; provided , however , that with respect to any such Dispute that relates to a matter described in Section 13.4, either Party shall have the right to seek an injunction or other equitable relief without waiting for the expiration of [***]-period;

(ii) if such Dispute constitutes a [***], the specific dispute resolution processes contained in Section 9.5(b) will apply;

(iii) if such Dispute regards the supply, quality or compliance with specifications of the Recipient Study Drug, the Dispute will be resolved by the Recipient; provided that (A) the Recipient shall have no authority to amend, change or waive compliance with this Agreement, which matters may be approved only by the written consent of both Parties, and (B) all determinations made by the Recipient shall be consistent with the terms of this Agreement.

(iv) any disputes relating to the supply, quality or compliance with specifications of the BMS Study Drug shall be the responsibility of BMS; provided that (A) BMS shall have no authority to amend, change or waive compliance with this Agreement, which matters may be approved only by the written consent of both Parties, and (B) all determinations made by BMS shall be consistent with the terms of this Agreement.

(c) If a Dispute that constitutes an Arbitration Matter remains unresolved [***] after such Dispute is referred to the Executive Officers as described above, either Party may refer the Dispute to arbitration as described herein. Any arbitration under this Section 13.3 shall be conducted under the auspices of the American Arbitration Association [***]. The fees and expenses of the arbitrators shall be borne [***]. Each Party shall bear the fees and expenses of its legal representation and of all its internal or external costs in conducting the arbitration. The arbitral tribunal shall not reallocate either the fees and expenses of the arbitrators or of the Parties’ legal representation. The arbitration shall be held in New York, New York, USA, which shall be the seat of the arbitration. The language of the arbitration shall be English. The arbitration shall be conducted according to the above Commercial Arbitration Rules then in effect.

13.4 Injunctive Relief. Notwithstanding anything herein to the contrary, a Party may seek an

[***] = Certain Confidential Information Omitted

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injunction or other injunctive relief from any court of competent jurisdiction in order to prevent immediate and irreparable injury, loss or damage on a provisional basis. For the avoidance of doubt, if either Party (a) discloses Confidential Information of the other Party other than as permitted under Article 9, (b) uses (in the case of the Recipient) the BMS Study Drug or BMS Technology or (in the case of BMS) the Recipient Study Drug or Recipient Technology in any manner other than as expressly permitted under this Agreement or (c) otherwise is in material breach of this Agreement and such material breach could cause immediate harm to the value of the Recipient Study Drug (if BMS is in material breach) or the BMS Study Drug (if the Recipient is in material breach), the other Party shall have the right to seek an injunction or other equitable relief precluding the other Party from continuing its activities related to the Combined Therapy Clinical Trial without waiting for the conclusion of the dispute resolution procedures under Section 13.3.

13.5 Force Majeure. A Party shall be excused from the performance of its applicable obligation(s) under this Agreement (other than the payment of monies owed to the other Party) to the extent that such performance is prevented by force majeure, and the non-performing Party promptly provides notice of the prevention to the other Party (including details of the force majeure) and uses reasonable efforts to avoid the effects of such force majeure and to perform the affected obligation(s) to the extent reasonably possible. Such excuse of performance shall be continued so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition or otherwise perform the affected obligation(s). For purposes of this Agreement, “force majeure” shall mean acts of God, strikes or other concerted acts of workers, civil disturbances, fires, earthquakes, acts of terrorism, floods, explosions, riots, war, rebellion, sabotage or failure or default of public utilities or common carriers or similar conditions beyond the reasonable control of the applicable Party. For clarity, notwithstanding the existence of a force majeure impacting a Party’s performance hereunder, such Party shall continue performing all its other obligations hereunder, and the other Party shall be excused from performing such of its obligations under this Agreement that it cannot reasonably perform due to the non-performance by the Party due to such force majeure, until such Party completes performance of such obligations that are prevented by such force majeure. In addition, if a Party is excused under this Section 13.5 from performance of its obligation due to a force majeure, and such non-performance is of a material obligation and such non-performance continues for a period of [***], then the other Party may terminate this Agreement on written notice.

13.6 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 deemed to have been sufficiently given for all purposes if such notice is timely and is: (a) mailed by first class certified or registered mail, postage prepaid, return receipt requested, (b) sent by express delivery service, or (c) personally delivered. Unless otherwise specified in writing, the mailing addresses of the Parties shall be as described below.

For the Recipient: [***]

With a copy to: [***]


For BMS:	[***]

[***] = Certain Confidential Information Omitted

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[***]

With a copy to: [***]

Any such communication shall be deemed to have been received when delivered. It is understood and agreed that this Section 13.6 is not intended to govern the day-to-day business communications necessary between the Parties in performing their duties, in due course, under the terms of this Agreement.

13.7 No Waiver; Modifications. It is agreed that no waiver by a Party of any breach or default of the other Party of any of its covenants or obligations under this Agreements shall be deemed a waiver as to any subsequent and/or similar breach or default by the other Party. To be binding on the Parties, all amendments or modifications to or of this Agreement must be by a written instrument that is duly executed by an authorized representative of each Party. No amendment or modification of the terms of this Agreement, or release or discharge of a Party’s obligation under this Agreement or breach thereof, shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties.

13.8 No Strict Construction. This Agreement has been prepared jointly and shall not be strictly construed against either Party. No presumption as to construction of this Agreement shall apply against either Party with respect to any ambiguity in the wording of any provision(s) of this Agreement irrespective of which Party may be deemed to have authored the ambiguous provision(s).

13.9 Independent Contractor. The Parties are independent contractors of each other, and the relationship between the Parties hereunder shall not constitute a partnership, joint venture or agency. Neither Party shall be the agent of the other. Neither Party shall have any authority to act for, or on behalf of, the other Party in any matter, except as expressly authorized by the specific terms of this Agreement.

13.10 Assignment.

(a) Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other Party, such consent not to be unreasonably withheld, except that a Party may make such an assignment without the other Party’s consent (i) to an Affiliate, (ii) to a Third Party successor in interest that merges with, consolidates with or acquires substantially all of the assets or voting control of the assigning Party, or (iii) to a Third Party successor in interest that acquires all (or substantially all of) the rights of the assigning Party to the Recipient Study Drug, in the case of the Recipient, or the BMS Study Drug, in the case of BMS. If assigned or transferred to an Affiliate, the assigning/transferring Party shall remain jointly and severally responsible and liable with the assignee/transferee Affiliate for the assigned rights and/or obligations. If assigned to a Third Party, any permitted successor or assignee of rights and/or obligations hereunder shall, in a writing to the other Party, expressly assume performance of such rights and/or obligations. Any purported assignment or attempted assignment by any Party in violation of the terms of this Section 13.10 shall be null and void and of no legal effect.

(b) If a Party grants a third party a license (other [***]) to develop and commercialize its Single Agent Compound on a worldwide basis or in any geographic region and/or for all purposes or a limited field (herein, a “ Licensee ”), such Party will [***]

[***] = Certain Confidential Information Omitted

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[***].

13.11 Headings. The captions to the several Sections and Articles hereof are not a part of this Agreement, but are included merely for convenience of reference only and shall not affect its meaning or interpretation.

13.12 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may be executed by facsimile or electronic (e.g., pdf) signatures and such signatures shall be deemed to bind each Party hereto as if they were original signature.

13.13 Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future law, and if the rights or obligations of a Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom, and (d) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties.

13.14 Further Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in order to perfect any license, assignment or other transfer or any properties or rights under, or pursuant, to this Agreement.

13.15 No Benefit to Third Parties. The representations, warranties, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties, their respective Affiliates, and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other parties.

13.16 Construction.

(a) General. Except as otherwise explicitly specified to the contrary, (i) references to a Section, Article or Exhibit means a Section or Article of, or Exhibit to, this Agreement and all subsections thereof, unless another agreement is specified, (ii) references to a particular statute or regulation include all rules and regulations promulgated thereunder and any successor statute, rules or regulations then in effect, in each case including the then-current amendments thereto, (iii) words in the singular or plural form include the plural and singular form, respectively, (iv) the terms “including,” “include(s),” “such as,” and “for example” used in this Agreement mean including the generality of any description preceding such term and will be deemed to be followed by “without limitation”, (v) the words “hereof,” “herein,” “hereunder,” “hereby” and derivative or similar words refer to this Agreement, (vi) “or” is used in the conjunctive (“and/or”) unless the context requires otherwise, (vii) “will” and “shall” are synonyms, (viii) references to “(sub)licensees” means Third Party licensees or sublicensees of a Party or its Affiliate, and (ix) days means calendar days. No presumption as to construction of this Agreement shall apply against either Party with respect to any ambiguity in the wording of any provision(s) of this Agreement irrespective of which Party may be deemed to have authored the ambiguous provision(s).

(b) No Response. Except as expressly set forth in this Agreement, where a provision of this Agreement provides for a Party to respond within a designated period following written notice from the other Party, and if such Party fails to respond, then the failure to respond shall not be deemed to create

[***] = Certain Confidential Information Omitted

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or imply: (i) that the non-responding Party agrees or disagrees with the proposed action to be taken by the other Party, (ii) any amendment, change or waiver of the terms of this Agreement, or (iii) any consent that an action proposed to be taken may be taken if it conflicts with the terms of this Agreement and/or waiver of any rights it may have to seek remedies at law or in equity for breach of this Agreement as a result of the action taken.

[ Signature page follows ]

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IN WITNESS WHEREOF , the Parties, intending to be legally bound hereby, have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.



Mirati Therapeutics, Inc.	Bristol-Myers Squibb Company
By: /s/ Dr. Charles Baum, M.D., Ph.D.	By: /s/ Fouad Namouni, M.D.
Name: Dr. Charles Baum, M.D., Ph.D.	Name: Fouad Namouni, M.D.
Title: President and Chief Executive Officer	Title: Head of Oncology Development
Date: January 3, 2019	Date: January 4, 2019

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Appendixes Index

Attached :

Appendix A : BeiGene Territory

Appendix B : Draft Protocol

Appendix C : Press Release

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APPENDIX A

BEIGENE TERRITORY

[***]

People’s Republic of China [***]

[***] = Certain Confidential Information Omitted

[***]

Australia

New Zealand

[***] = Certain Confidential Information Omitted

APPENDIX B

[***]

[***] = Certain Confidential Information Omitted

APPENDIX C

PRESS RELEASE

See attached draft Press Release - Version Date: 02 January 2019

SUPPLY/QUALITY ADDENDUM with Mirati Therapeutics

This Supply Addendum relates to the CLINCIAL TRIAL COLLABORATION AND SUPPLY AGREEMENT (the “ Agreement) entered into effective as of January 3, 2019 by and between Bristol Myers Squibb (“BMS”) and Mirati Therapeutics, Inc. (“RECIPIENT”) The terms in this Supply/Quality Addendum with initial letters capitalized shall have the meaning set forth in the Agreement if not otherwise defined in this Supply/Quality Addendum.

BMS shall supply, free of charge, to the location(s) specified by RECIPIENT below, in sufficient quantity for subjects participating in the Combined Therapy Clinical Trial (specifically protocol 516-005, “A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab Versus Docetaxel in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer with Disease Progression On or After Platinum-Based Chemotherapy in Combination with Checkpoint Inhibitor Therapy” referred to as the “STUDY”) at STUDY centers, based on the [***] below; provided that any request by RECIPIENT for nivolumab (“BMS STUDY DRUG”) in addition to the [***] below, will require prior written approval by the Parties, (which agreement can be effected by the Parties’ [***]), and [***].

Quality related provisions pertaining to the supply of the BMS STUDY DRUG are contained in Appendix 1 to this Supply Addendum.

Supply . BMS will provide commercially packaged and labeled BMS STUDY DRUG free of charge to RECIPIENT for subjects participating in the STUDY at STUDY centers.

BMS will supply BMS STUDY DRUG manufactured in accordance with GMP in:

Commercially labeled and packaged [***] mg vials of nivolumab

Shipment . Shipment of the BMS STUDY DRUG may require a lead time of [***] from the time of RECIPIENT’s order after the complete execution of the Agreement. BMS shall deliver to the RECIPIENT Vendor/Depot the quantity of BMS Study drug ordered by the delivery date specified in the applicable order if such delivery date is at least [***] after such order is placed and shall otherwise discuss with BMS [***].

[***] = Certain Confidential Information Omitted

Forecasting . RECIPIENT will provide BMS with a [***] forecast in advance of STUDY start up, and then provide BMS with an update of the [***] forecast each [***] thereafter.

Packaging and Labeling . BMS will provide US and EU commercially packaged/labeled material in accordance with the terms outlined in the Drug Responsibility Matrix below. BMS will bear the costs that it incurs in its performance under the Agreement of the [***] activities assigned to BMS under the Drug Responsibility Matrix. RECIPIENT will bear the costs that it incurs in its performance under the Agreement of the [***] assigned to RECIPIENT under the Drug Responsibility Matrix.

Storage of BMS STUDY DRUG prior to Shipment . BMS shall store and maintain BMS STUDY DRUG prior to shipment to RECIPIENT in accordance with GMP.

Site/Local Depot Specific Drug Orders . RECIPIENT will be responsible for processing all BMS STUDY DRUG shipment orders in a timely fashion as needed at the study centers or local depots after delivery to the RECIPIENT Depot(s)/Vendor(s) listed below.

Shipping and Distribution . BMS is responsible for shipments to RECIPIENT Depot(s)/vendor(s) at the addresses for it set forth below from BMS vendor facilities in accordance with GDP. RECIPIENT will be responsible for shipments to STUDY centers or local depots.

Customs . BMS shall obtain at its own risk and expense any export license or other official authorization and customs formalities necessary for the export of goods from BMS’ warehouse/facilities/vendor. BMS shall be responsible for all applicable import taxes and duties related to shipment of BMS STUDY DRUG.

Delivery Schedule . Below is the initial estimate of total BMS STUDY DRUG required from BMS. If RECIPIENT wishes to obtain additional quantities, it shall provide BMS at least [***] advanced written notice, and such request will be mutually agreed upon via [***].

[***] study FPFV date : [***]

[***] Schedule of Deliveries :



Delivery Date	Product	Quantity of Vials	Source of Commercial Product
[***]	[***]	[***]	[***]
[***]	[***]	[***]	[***]
[***]	[***]	[***]	[***]
[***]	[***]	[***]	[***]
[***]	[***]	[***]	[***]

[***] = Certain Confidential Information Omitted



[***]	[***]	[***]	[***]
[***]	[***]	[***]	[***]
[***]	[***]	[***]	[***]
[***]	[***]	[***]	[***]

RECIPIENT’s depot(s)/vendor(s) contact information :

Vendor Name (US): [***]

Vendor Name (EU): [***]

[***] = Certain Confidential Information Omitted

Countries in which STUDY will occur :

[***]

Drug Responsibility Matrix

[***]

[***] = Certain Confidential Information Omitted

DRUG SUPPLY CONTACTS

CONTACTS FOR MIRATI-SPONSORED CLINICAL TRIAL



BMS Contacts
Contact for Drug Supply	[***]



Mirati Therapeutics Inc. Contacts
Contact for Drug Supply	[***]

[***] = Certain Confidential Information Omitted

APPENDIX 1:

Quality Appendix

[***]

[***] = Certain Confidential Information Omitted

APPROVALS:

Mirati Therapeutics Inc

/s/ Sanjeev Sharma March 14, 2019

Sanjeev Sharma Date

Senior Vice President

CMC & Product Development

/s/ Christine Cuellar March 14, 2019

Christine Cuellar Date

Director

Quality Assurance

BMS

/s/ Janice Salmon March 19, 2019

Janice Salmon Date

Site Quality Director

Product Development & Clinical Supply Quality

/s/ Douglas Baylis March 19, 2019

Douglas Baylis Date

Senior Drug Supply Manager

Clinical Supply Services

History



Version Number	Comment	Issue Date
1	Original Agreement	See signature page for last approval date*

Exhibit 10.2

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE MIRATI THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO MIRATI THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

DRUG DISCOVERY COLLABORATION OPTION AGREEMENT

THIS DRUG DISCOVERY COLLABORATION OPTION AGREEMENT (the “ Agreement ”) is made effective as of October 1, 2014 (“ Effective Date ”) by and between Array BioPharma Inc., a Delaware corporation, having its principal offices located at 3200 Walnut, Boulder, CO 80301 (“ Array ”), and Mirati Therapeutics, Inc., a Delaware corporation, having a place of business at 9363 Towne Centre Drive, Suite 200, San Diego, CA 92121 (“ Mirati ”).

BACKGROUND

A. Array has skills, expertise and technology relating to the discovery and development of therapeutics that modulate molecular targets involved in oncology and other disease areas.

B. Mirati is engaged in the discovery, development and commercialization of therapeutics.

C. Mirati and Array desire to establish a collaboration to apply Array’s expertise and technology to the discovery, optimization and development of small molecule compounds that [***] a certain Target (as defined herein), and to establish an option mechanism whereby Mirati may elect an exclusive (even as to Array), worldwide license under Array technology for the development and commercialization of certain products based on such compounds, all on the terms and conditions set forth in this Agreement.

NOW, THEREFORE, in consideration of the premises and mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:

ARTICLE I
DEFINITIONS

The following terms shall have the following meanings as used in this Agreement:

1.1 “ Active Compound ” shall mean any Compound having that level of activity against the Target in the applicable assay(s) as set forth in Schedule 1.1 .

1.2 “ Affiliate ” of a Party shall mean any person, corporation or other entity that, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Party, as the case may be, for so long as such control exists. As used in this Section 1.2,

-1-

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

“ control ” shall mean: (a) to possess, directly or indirectly, the power to direct the management and policies of such person, corporation or other entity, whether through ownership of voting securities or by contract relating to voting rights or corporate governance; or (b) direct or indirect beneficial ownership of at least fifty percent (50%) (or such lesser percentage that is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of the voting share capital in such person, corporation or other entity.

1.3 “ Annual Net Sales ” shall mean total Net Sales of Products in a particular calendar year, as derived from audited financial statements of Mirati (or the applicable Affiliate or Sublicensee), provided, however, that Mirati shall use U.S. generally accepted accounting principles to calculate in good faith the Net Sales from any entities that are not audited or have not completed their audit within [***] of the end of the preceding calendar year.

1.4 “ Array Background Technology ” shall mean all Patents and Information Array Controls on the Effective Date or during the Term, which are necessary to develop, have developed, make, have made, use, sell, have sold, offer for sale and import Active Compounds and Products in the Field and in the Territory. As used in this Section 1.4, “Control” shall mean, with respect to any Patents, Information or other intellectual property right, possession by Array or its Affiliates, of the ability (whether by ownership, license, or otherwise, and without regard to the rights granted under this Agreement), to grant access, a license, or a sublicense to such Patents, Information or other intellectual property right without violating the terms of any agreement with any Third Party as of the time such access and without incurring any payment obligation (unless the Mirati agrees to pay such payment obligation), license or sublicense is granted to Mirati hereunder.

1.5 “ Clinical Candidate ” shall mean any Active Compound that meets the Clinical Candidate Criteria.

1.6 “ Clinical Candidate Criteria ” shall mean the criteria mutually agreed to by the Parties, as set forth in Schedule 4.1.2 .

1.7 “ Collaboration Technology ” shall mean any and all Collaboration Patent Rights and Collaboration Know-How.

1.7.1 “ Collaboration Patent Rights ” shall mean all Patents the subject of which is an invention conceived and reduced to practice by or on behalf of Array solely and/or by or on behalf of Array jointly with Mirati or any Third Party, or that is conceived and reduced to practice by or on behalf of Mirati solely and/or by or on behalf of Mirati jointly with any Third Party, in the course of

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performing the Feasibility Program or the Discovery Program, that claim an Active Compound or Product or method of use or process for the synthesis or making thereof or composition-of-matter containing such Active Compound or Product, which are necessary to develop, have developed, make, have made, use, sell, have sold, offer for sale and import Active Compounds and Products in the Field and in the Territory.

1.7.2 “ Collaboration Know-How ” shall mean all Information developed or generated by or on behalf of Array solely and/or by or on behalf of Array jointly with Mirati or any Third Party, or made by or on behalf of Mirati solely and/or jointly with any Third Party, during and in connection with the Feasibility Program or the Discovery Program, in each case, which is necessary to develop, have developed, make, have made, use, sell, have sold, offer for sale and import Active Compounds and Products in the Field and in the Territory.

1.8 “ Combination Product ” shall mean a Product incorporating two or more therapeutically active ingredients and including an Active Compound as one of its active ingredients. Notwithstanding the foregoing, drug delivery vehicles, adjuvants, and excipients shall not be deemed to be “therapeutically active ingredients,” and their presence shall not be deemed to create a Combination Product under this Section 1.8.

1.9 “ Commercially Reasonable Efforts ” shall mean the carrying out of obligations or tasks in a manner consistent with the efforts a Party devotes to a product or a research, development or marketing project at a similar stage of research or development that is of similar market potential, profit potential or strategic value resulting from its own research efforts, and taking into account efficacy profile, safety profile, approved labeling, competitive landscape, Patent and other intellectual property position, regulatory status and likelihood of regulatory approval with respect to such product, but in no event using less than the commercially reasonable standards applied by other public biotechnology companies to their pharmaceutical products at a similar stage of research or development that is of similar market potential, and profit potential or strategic value, but not taking into account the interests of Mirati’s or its Affiliates’ or Sublicensees’ other products and services.

1.10 “ Compound ” shall mean a small molecule chemical entity (a) that is first synthesized and/or assayed by or on behalf of a Party in the course of performing activities under the Feasibility Program or the Discovery Program; and (b) that [***] the Target. It is understood and agreed that “Compound” shall not include any Library Compound.

1.11 “ Discovery Plan ” shall mean the written research plan mutually agreed to by the

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Parties, as set forth in Section 5.3.

1.12 “ Discovery Program ” shall mean the research activities undertaken by the Parties pursuant to Article 5 below, as more specifically defined in Section 5.1.

1.13 “ Discovery Program Term ” shall mean the term of the Discovery Program, as provided in Section 5.5 below.

1.14 “ Europe ” shall mean any country, nation, state or other territory under the jurisdiction of the European Medicines Agency (EMA) or any successor thereto, as such jurisdiction may change from time to time.

1.15 “ FDA ” shall mean the United States Food and Drug Administration, or any successor entity thereto performing similar functions.

1.16 “ Field ” shall mean the treatment or prevention of any disease or condition in humans.

1.17 “ First Commercial Sale ” means, with respect to a particular Product in a given country, the first bona fide commercial sale of such Product following Marketing Approval (including pricing or reimbursement approval, if applicable) in such country by or under authority of Mirati, its Affiliates, or Sublicensees.

1.18 “FTE Rate” shall mean the annual amount of US$[***].

1.19 “ GAAP ” shall mean generally accepted accounting principles as applicable in the United States of America.

1.20 “ Information ” shall mean materials, data and other information, including to the extent relating to the subject matter of, or arising under, this Agreement, and includes without limitation: (a) ideas, techniques, data, including screens, models, inventions, methods, test data (including, pharmacological, toxicological and clinical test data), instructions, processes, formulas, expert opinions, analytical and quality control data, biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, clinical, safety, manufacturing and quality control data and information, marketing, pricing, distribution, costs, and sales data, manufacturing information, and patent and legal data or descriptions (to the extent that disclosure thereof would not result in loss or waiver of privilege or similar protection); and (b) information pertaining to compositions of matter, including compounds, biological materials and assays. For purposes of this Agreement, (i) the subject matter and content of all JAC discussions and meetings shall be deemed Information herein; and (ii)

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“ clinical test data ” shall be deemed to include all information related to the clinical or preclinical testing of a Compound or Product, including patient report forms, investigators’ reports, biostatistical, pharmaco-economic and other related analyses, regulatory filings and communications, and the like.

1.21 “ Initiation ” of a particular clinical trial shall be deemed to occur upon the date of first dosing of the first subject.

1.22 “ JAC ” or “ Joint Advisory Committee ” shall have the meaning set forth in Section 2.1.

1.23 “ Library Compound ” shall mean a chemical entity, [***], that is [***].

1.24 “ Marketing Approval ” shall mean all approvals, licenses, registrations or authorizations of a Regulatory Authority in a country necessary for the manufacture, use, storage, import, marketing and commercial sale of a Product in such country.

1.25 “ Marketing Approval Application ” or “ MAA ” shall mean a New Drug Application (as defined in 21 C.F.R. § 314.50 et. seq .) or a comparable application for Marketing Approval (including pricing or reimbursement approval, if required in the applicable jurisdiction) in another jurisdiction, in each case with respect to a Product.

1.26 “ Net Sales ” shall mean the gross invoice price by Mirati or its Affiliates or Sublicensees, as the case may be, for all Products sold by Mirati, its Affiliates or Sublicensees (“Selling Party”), under this Agreement in arm’s length sales to Third Parties less deductions allowed to the Third Party customer by the Selling Party on such sales for:

(a) [***];

(b) [***];

(d) [***]; and

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(e) [***].

Sales among the Selling Party and its Affiliates and/or Sublicensees shall be excluded from the computation of Net Sales, and no royalties will be payable on such sales except where such Affiliates or Sublicensees are end users; provided, however, in each case that any subsequent resale to a Third Party shall be included within Net Sales. In addition, the Selling Party may exclude from Net Sales a reasonable provision for uncollectible accounts, to the extent such reserve is determined in accordance with GAAP, consistently applied across all product lines of the particular Party, until such amounts are actually collected. Net Sales shall not include, and no royalty shall be due on, Products used in clinical trials or other research and development activities, or Products given as samples.

In the event a Product is sold which is a Combination Product (as defined in Section 1.8), for purposes of determining payments due Array under Section 7.9, Net Sales of such Combination Product shall be calculated by [***] during the applicable accounting period. All Gross Selling Prices of the applicable Product and other product used in determining [***] shall be calculated as the average Gross Selling Price of such Product and other product during the applicable accounting period for which the Net Sales are being calculated. In the event that the Gross Selling Price for such Product used to determine [***] cannot be determined for an given accounting period, Net Sales of the applicable Combination Product shall be determined using [***] as reasonably agreed by the parties (which [***], if not mutually agreed by the Parties, shall be determined pursuant to the dispute resolution procedures set

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forth in this Agreement). For purposes of this Section 1.25, “ Gross Selling Price ” shall mean the gross price at which a product is sold to a Third Party, before discounts, deductions, credits, taxes or allowances.

1.27 “ Option ” shall have the meaning set forth in Section 4.1.

1.28 “ Option Term ” shall have the meaning set forth in Section 4.1.1(a).

1.29 “ Party ” or “ Parties ” shall mean Array and/or Mirati.

1.30 “ Patents ” shall mean (i) all patents, patent applications, certificates of invention, applications for certificates of invention, and priority patent filings (including without limitation patent applications under the Patent Cooperation Treaty and the European Patent Convention), together with (ii) any renewals, divisions, continuations, continuations-in-part, or requests for continued examination of any such patents, patent applications, certificates of invention, applications for certificates of invention, and priority patent filings, and any and all patents and certificates of invention issuing thereon, and any and all reissues, reexaminations, extensions, divisions, renewals, substitutions, confirmations, registrations, revalidations, revisions, and additions to any of the foregoing, and any foreign counterparts of any of the foregoing, and any other patents, patent applications, certificates of invention, applications for certificates of invention, and priority patent filings claiming priority back to any of the foregoing.

1.31 “ Phase I ” shall mean a human clinical trial conducted on a limited number of study subjects for the purpose of gaining evidence of the safety and tolerability of, and information regarding pharmacokinetics and, with respect to applicable oncology trials, potential pharmacological activity for, a product or compound, as described in 21 C.F.R.§ 312.21(a) (including any such clinical study in any country other than the United States).

1.32 “ Phase II ” shall mean a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy and/or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

1.33 “ Phase III ” shall mean a human clinical trial, the principal purpose of which is to establish safety and efficacy in study subjects with the disease or condition being studied, as further described in 21 C.F.R. §312.21(c) (including any such clinical study in a country other than the United

States), which is designed and intended to be of a size and statistical power sufficient to serve as a pivotal study to support the filing of a MAA for the indication being studied.

1.34 “ Product ” shall mean any pharmaceutical product for use in the Field incorporating as an active ingredient an Active Compound.

1.35 “ Regulatory Authority ” shall mean the FDA, or a regulatory body with similar regulatory authority in any jurisdiction outside the United States.

1.36 “ Sublicensee ” shall mean, with respect to a particular Active Compound, Clinical Candidate or Product, a Third Party to whom Mirati or its Affiliate has granted a license or sublicense to develop, make and/or sell such Active Compound, Clinical Candidate or Product; and a “sublicense” shall mean any agreement or arrangement between Mirati or its Affiliate and a Sublicensee granting such rights.

1.37 “ Target ” shall mean the protein target listed on Schedule 1.37 attached hereto.

1.38 “ Territory ” shall mean worldwide.

1.39 “ Third Party ” shall mean any entity other than Array, Mirati and their respective Affiliates.

1.40 “ Valid Claim ” shall mean (a) a claim of an issued and unexpired Patent (including the term of any patent term extension, supplemental protection certificate, renewal or other extension) which has not been: (i) held unpatentable, invalid or unenforceable in a final decision of a court or other government agency of competent jurisdiction from which no appeal may be or has been taken, or (ii) admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise; or (b) a claim of a patent application, which claim has been pending less than five (5) years from the original filing date of such claim in a given country, unless or until such claim thereafter issues as a claim of an issued Patent (from and after which time the same shall be deemed a Valid Claim subject to paragraph (a) above).

1.41 Additional Definitions . Each of the following terms shall have the meaning described in the corresponding section of this Agreement below.



Term	Section Defined
Array Indemnitees	12.4



Term	Section Defined
Mirati Indemnitees	12.5
Change of Control	6.5
Claim	12.6
Confidential Information	11.1
Development Milestone	7.6
Dispute	14.1
Feasibility Program	3.1
force majeure event	14.5
Indemnitor	12.6
Indemnitee	12.6
Liabilities	12.4
Minimum Annual Funding	7.4
Option Exercise Fee	7.3
Option Extension Fee	7.2
Results	11.1
Sales Milestone	7.7.1
Subject Transaction	14.3.2
Term	13.1
Withholding Taxes	8.3

ARTICLE II
GOVERNANCE

2.1 General . The Parties shall establish a Joint Advisory Committee (“ JAC ”) to oversee and coordinate activities under the Feasibility Program and, if Mirati exercises the Option, the Discovery Program. The JAC may from time to time establish subcommittees to handle matters within the scope of its authority.

2.1.1 Joint Advisory Committee . Within [***] following the Effective Date, Array and Mirati shall establish a Joint Advisory Committee.

(a) Duties . The JAC shall:

(i) establish, oversee, review and coordinate the Feasibility Program and, if Mirati exercises the Option, the Discovery Program, including assigning activities to

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be performed by each Party under the Feasibility Program and, if applicable, the Discovery Program, which may require the Parties to enter into material transfer and other appropriate agreements in connection with such activities;

(ii) coordinate a collaborative lead validation and optimization program to identify Active Compounds;

(iii) amend as necessary the criteria for the selection of Clinical Candidates;

(iv) provide a forum for the Parties: (1) to discuss the objectives of the Feasibility Program and the Discovery Program; and (2) to exchange and review scientific information and data relating to the activities being conducted under, and the then-current progress of, the Feasibility Program and the Discovery Program, including the exchange and review of data, Active Compound structures and the like resulting from the Feasibility Program and the Discovery Program; and

(v) make any such decisions as are expressly allocated to the JAC under this Agreement.

(b) Termination of JAC . Unless earlier terminated pursuant to Section 2.2.5, the JAC shall exist until the later of: (i) the end of the Option Term; and (ii) if the Option was exercised, the end of the Discovery Program.

2.2 Committee Membership and Procedures .

2.2.1 Committee Membership . The JAC shall each be composed of [***] representatives from each of Mirati and Array. Each Party may replace any of its representatives at any time with prior written notice to the other Party; provided that such replacement is of comparable standing and authority within that Party’s organization as the person he or she is replacing. Subcommittees the JAC may establish to oversee particular projects or activities, and such subcommittees will be constituted as the JAC agrees.

2.2.2 Committee Meetings . The JAC shall hold an initial joint meeting within [***] after the Effective Date or as otherwise agreed by the Parties. Thereafter, the JAC shall meet at least once every month, unless the JAC otherwise agrees. All JAC meetings may be conducted by telephone, video-conference or in person as determined by the JAC; provided, however, that the

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JAC shall meet in person at least once each calendar quarter, unless the Parties mutually agree to meet by alternative means. Unless otherwise agreed by the Parties, all in-person meetings for the JAC shall be held on an alternating basis between Array’s facilities and Mirati’s facilities. With the consent of the Parties (not to be unreasonably withheld or delayed), a reasonable number of other representatives of a Party may attend any JAC meeting as non-voting observers (provided that such additional representatives are under obligations of confidentiality and non-use applicable to the Confidential Information of the other Party that are at least as stringent as those set forth in Article 11). Each Party shall be responsible for all of its own personnel and travel costs and expenses relating to participation in JAC meetings.

2.2.3 Minutes . The JAC shall keep accurate minutes of its deliberations which shall record all proposed decisions and all actions recommended or taken. The Secretary of the JAC (as appointed by the members of the JAC) shall be responsible for the preparation of draft minutes. Draft minutes shall be sent to all members of the JAC within five (5) working days after each meeting and shall be approved, if appropriate, at the next meeting. All records of the JAC shall at all times be available to both Array and Mirati.

2.2.4 Decision-Making . Decisions of the JAC shall be made by [***].

2.3 Scope of Governance . Notwithstanding the creation of the JAC, each Party shall retain the rights, powers and discretion granted to it under this Agreement, and the JAC shall not be delegated or vested with rights, powers or discretion unless such delegation or vesting is expressly provided herein, or the Parties expressly so agree in writing. The JAC shall not have the power to amend or

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modify this Agreement, and no decision of the JAC shall be in contravention of any terms and conditions of this Agreement. It is understood and agreed that issues to be formally decided by the JAC are only those specific issues that are expressly provided in this Agreement to be decided by the JAC.

ARTICLE III

FEASIBILITY PROGRAM

3.1 Feasibility Program . During the Option Term, Array shall be responsible [***] during the Option Term (“ Feasibility Program ”). During the Option Term, Array shall use Commercially Reasonable Efforts to conduct the Feasibility Program.

3.2 Feasibility Program Funding . Except as otherwise expressly provided in this Agreement, Array will be responsible for funding its activities under the Feasibility Program during the Option Term. If Mirati determines that additional work would accelerate or improve the Feasibility Program, Array agrees to reasonably cooperate in facilitating such additional work which shall be performed at Mirati’s expense.

3.3 Updates; Reports . During the Option Term, Array shall provide to Mirati through the JAC with regular written updates no less than [***] on the results of the Feasibility Program. [***] Array shall provide the JAC with a written summary of the activities conducted under the Feasibility Program for the preceding [***] and supporting data related thereto. Mirati shall have the right to reasonably request and to receive in a timely manner clarifications and answers to questions with respect to such reports.

3.4 Records .

3.4.1 Retention . Array shall maintain, or cause to be maintained records of all activities conducted under the Feasibility Program, in a scientific manner as will properly reflect all work done and results achieved in the performance of the Feasibility Program and which are otherwise sufficient to determine the identity and inventorship dates of inventions. Array shall retain such

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records until the end of the Option Term, and shall provide such records to Mirati on Mirati’s request after Mirati exercises the Option.

3.4.2 Inspection . During the Option Term, Array shall make available to Mirati for review and copying, as reasonably requested and upon reasonable notice, during Array’s normal business hours, such records as may be reasonably necessary for Mirati: (a) to review details of the results generated under the Feasibility Program; (b) to supplement the reports furnished by Array pursuant to Section 3.3 above; and/or (c) to audit other costs which are reimbursable by Mirati hereunder. Such disclosures shall occur no more than once [***] during the Option Term and shall be pursuant to reasonable procedures to protect the confidentiality of such records.

ARTICLE IV

MIRATI OPTION

4.1 Mirati Option . During the Option Term, Mirati shall have the exclusive option to acquire an exclusive (even as to Array), worldwide license to develop and commercialize Active Compounds as set forth in Section 6.2 (the “ Option ”), all in accordance with the terms and conditions set forth in this Article 4.

4.1.1 Exercise .

(a) Option Term . Mirati may exercise the Option at any time on or before the first anniversary of the Effective Date, or on or before the applicable extended date, as extended herein (the “ Option Term ”); provided that the Option Term shall terminate upon the earlier of: (i) termination of this Agreement in accordance with Article 13; or (ii) the date on which Mirati exercises the Option. Mirati may extend the Option Term for up to [***] additional [***] periods upon written notice to Array and payment of the applicable Option Extension Fee set forth in Section 7.2, such notice to be provided on or prior to the first anniversary of the Effective Date or on or prior to the end of the then-current extended Option Term, as applicable.

(b) Exercise . To exercise the Option, Mirati shall so notify Array in writing at any time during the Option Term and pay to Array the Option Exercise Fee set forth in Section 7.3.

4.1.2 Discovery Plan . Upon exercise of the Option, the JAC or its designated subcommittee will provide recommendations to the Parties for any modifications to the Discovery Program, including without limitation any proposed modifications to the Clinical Candidate Criteria (with corresponding proposed updates to Schedule 4.1.2, as applicable). At such time, the Parties will

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agree upon a budget setting forth the amounts to be paid to Array during its performance of the Discovery Program, and subject to and in accordance with Article VII.

4.1.3 Termination . In the event that Mirati fails to exercise its Option in accordance with Section 4.1.1 above, then this Agreement and the Option shall terminate. Array shall thereafter be free to develop such Compounds and other compounds that modulate the activity of the Target outside the collaboration, alone or in connection with Third Parties.

ARTICLE V
DISCOVERY PROGRAM

5.1 If Mirati exercises the Option, the Parties will collaborate on a discovery program, pursuant to the Discovery Plan and in accordance with this Article V, with the goal of identifying and developing [***] Clinical Candidates in the Field (herein, the “Discovery Program”).

5.2 Conduct of the Discovery Program . Subject to the terms and conditions set forth herein, upon exercise of the Option by Mirati, the Parties agree to conduct the Discovery Program, which shall be funded as set forth in Article VII below. During the Discovery Program Term, Array and Mirati shall collaborate and each use Commercially Reasonable Efforts to conduct the Discovery Program in accordance with the Discovery Plan, and to perform their respective obligations therein, within the time schedules contemplated therein and to keep the other Party informed as to the progress and results of the Discovery Program hereunder.

5.3 Discovery Plan . The Discovery Program shall be carried out in accordance with a mutually agreed upon written discovery plan, which shall establish specific research objectives and the research tasks to be performed and resources to be provided by each Party (herein, the “Discovery Plan”). Within [***] of Mirati’s exercise of the Option, the Parties shall develop and finalize the Discovery Plan. The Discovery Plan also will include [***]. The Discovery Plan shall be reviewed on an ongoing basis and may be amended only by written agreement of the Parties.

5.4 Designation of Clinical Candidates . From time to time, after Mirati’s exercise of the Option, [***]

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[***]. [***], each such Active Compound so designated shall be deemed a Clinical Candidate for the purposes of this Agreement.

5.5 Term of Discovery Program . The Discovery Program Term shall commence on the date of exercise by Mirati of the Option and, unless earlier terminated as permitted under Article 13, or extended in accordance with the terms herein shall end upon the second anniversary of the date of exercise by Mirati of the Option (the “ Discovery Program Term ”). The Discovery Program Term may be extended for an additional year upon mutual consent of the Parties.

5.6 Third Party Licenses . In the event that the Parties agree to acquire additional technologies from a Third Party specifically for use in the conduct of the Discovery Program, Mirati will be responsible for the payment of any amounts due to Third Parties for the license of intellectual property which directly applies to any Target, and the costs of negotiating, preparing and executing any such license.

5.7 Records; Inspection .

5.7.1 Records . Array and Mirati shall each maintain records of the Discovery Program (or cause such records to be maintained) in sufficient detail and in good scientific manner, and in accordance with US GAAP with respect to financial records, as will properly reflect all work done, results achieved and costs incurred in the performance of the Discovery Program (including all data in the form required under any applicable governmental regulations and as directed by the JAC). Array shall maintain such records during the Discovery Program Term and for a period of [***] thereafter, and shall provide Mirati access to such records at Array’s place of business and allow Mirati to make copies thereof, upon reasonable advance notice from Mirati.

5.7.2 Reports and Information Exchange . During the Discovery Program Term, each of Mirati and Array shall use Commercially Reasonable Efforts to disclose to the other Party in writing all material information relating to the Discovery Program, including without limitation any Active Compound and/or Clinical Candidate, promptly after it is learned or its materiality is appreciated. Each Party shall also keep the other Party, including the JAC, informed in writing as to its progress under the Discovery Plan. Within [***] following the end of each calendar quarter of the Discovery Program, Array shall provide Mirati with a reasonably detailed written report describing the progress to date of all activities completed during such quarter under the Discovery Plan.

5.7.3 Library Compounds . Notwithstanding any other provision of this Article V,

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Array shall not be required to [***] required for a Compound to be an Active Compound.

5.8 Post Discovery Program Activities . For each Active Compound, Clinical Candidate and Product to which Mirati retains or is granted rights under this Agreement, following the completion of the Discovery Program and termination of the Discovery Program Term, as extended, Mirati shall be responsible, at its sole expense, for conducting all additional preclinical and clinical development of such Active Compound, Clinical Candidate or Product, and all commercialization of such Clinical Candidate or Product, in accordance with Article 9.

5.9 Development . Mirati shall be responsible, at its expense, for the preparation and filing of all MAAs with respect to any subsequent clinical development for an Active Compound, Clinical Candidate or Product. Array shall also provide to Mirati in writing, in support of any Mirati Marketing Approval Application filings, all relevant non-clinical data, including CMC, pharmacology and toxicology generated by Array with respect to such Active Compound or Product.

ARTICLE VI
LICENSE GRANTS; EXCLUSIVITY

6.1 Research Licenses . Subject to the terms and conditions of this Agreement:

6.1.1 To Array . Mirati hereby grants to Array a non-exclusive worldwide license to make and use and otherwise exploit subject matter within Mirati’s rights under the Collaboration Technology to the extent necessary: (a) to conduct the Feasibility Program during the Option Term; (b) to conduct the Discovery Program in accordance with the applicable Discovery Plan during the Discovery Program Term.

6.1.2 To Mirati . Array hereby grants to Mirati and its Affiliates a co-exclusive (with Array) worldwide license to make and use and otherwise exploit subject matter within Array’s rights under the Array Background Technology and/or Collaboration Technology to the extent necessary to: (a) cooperate with Array in connection with the performance of the Feasibility Program during the Option Term; and (b) conduct the activities assigned to or undertaken by Mirati and/or its Affiliates under the Discovery Program in accordance with the Discovery Plan during the Discovery Program Term.

6.1.3 Sublicenses . The licenses granted under this Section 6.1 shall not include the right to grant or authorize sublicenses; provided, however, that the [***].

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6.2 Commercial License to Mirati .

6.2.1 License Grant . Subject to the terms and conditions of this Agreement, on and from the date of Mirati’s exercise of the Option, Array hereby grants Mirati and its Affiliates a worldwide, exclusive (even as to Array) license under Array’s interest in any Collaboration Technology, and under the Array Background Technology, to develop, have developed, make, have made, use, sell, have sold, offer for sale and import Active Compounds and Products in the Field and in the Territory.

6.2.2 Sublicenses . The license granted under this Section 6.2 shall include the right to grant and authorize sublicenses to Third Parties, directly or indirectly through multiple tiers of sublicense; provided that Mirati shall remain responsible for the compliance of such Sublicensees and Affiliates with the applicable terms of this Agreement. Each sublicense granted by Mirati shall be consistent with all of the terms and conditions of this Agreement and subordinate thereto, and Mirati shall remain responsible to Array for the compliance of each such Sublicensee with the financial and other obligations due under this Agreement. [***].

6.3 No Other Rights . Except for the rights expressly granted under this Agreement, no right, title or interest of any nature whatsoever is granted, whether by implication, estoppel or otherwise, by any Party to the other Party. All rights with respect to Information, Patents or other intellectual property rights that are not specifically granted herein are reserved to the owner thereof.

6.4 No Implied Licenses . Each Party acknowledges that the licenses granted under this Article 6 are limited to the scope expressly granted, and all other rights to Patents and Information of a Party are expressly reserved to that Party owning such Patents and Information. Without limiting the foregoing, it is understood that where an exclusive license under any Patent and/or Information is granted to a Party under this Article 6 for a particular purpose, the Party granting such license retains all of its rights to such Patent and/or Information for all purposes not expressly licensed.

6.5 Exclusivity of Efforts . Except for [***]

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[***], during the Term of this Agreement, neither Party shall conduct, participate in, or fund, directly or indirectly, alone or with any Affiliate or any Third Party, any activities directed to the discovery, development, or commercialization of any compound that [***] the activity of the Target; provided, however , in the event of a Change of Control (as defined below) of a Party, the foregoing limitation shall not apply to that portion of the surviving entity that was not a Party hereto (prior to the Change of Control), whether with respect to any research or development programs, or other such activity or efforts, that such portion of the surviving entity had ongoing as of or immediately prior to the date of such Change of Control. For purposes of this Section 6.5, a “Change of Control” shall mean the sale of substantially all of the assets of a Party or the merger, consolidation, or similar transaction or series of transactions affecting a Party, as a result of which the affected Party’s shareholders before such transaction or series of transactions own less than fifty percent (50%) of the total number of voting securities of the surviving entity immediately after such transaction or series of transactions. For clarity, if as a result of any such Change of Control, a Party exists as a wholly owned subsidiary of a parent, then the provisions of this Section 6.5 shall continue to apply to the Party, but not to such parent.

ARTICLE VII

PAYMENTS

7.1 Initial Payment . In consideration of Array’s performance of its obligations under the Feasibility Program and further in consideration of the rights and licenses granted by Array to Mirati in this Agreement, Mirati shall pay to Array an initial fee of [***] Dollars ($[***]) within [***] following the Effective Date in accordance with the payment provisions of Article 8. The initial fee set forth in this Section 7.1 shall not be refundable or creditable against any other amounts due Array under this Agreement.

7.2 Option Extension Fees . In partial consideration of Array’s performance of its obligations under the Feasibility Program and the rights granted by Array to Mirati to extend the Option Term, Mirati shall pay to Array a fee of [***] Dollars ($[***]) for the first [***] extension and a fee of [***] Dollars ($[***]) for the second [***] extension (each an “ Option Extension Fee ”). The Option Extension Fees set forth in this Section 7.2 shall not be refundable or creditable against any other amounts due Array under this Agreement.

7.3 Option Exercise Fee . Upon exercise of the Option, Mirati shall pay to Array an option exercise fee of [***] Dollars ($[***]) within [***]

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following Mirati’s exercise of the Option, such payment in accordance with the payment provisions of Article 8 (the “ Option Exercise Fee ”). The option exercise fee set forth in this Section 7.3 shall not be refundable or creditable against any other amounts due Array under this Agreement.

7.4 Discovery Program Funding . Subject to the limitations set forth below, Mirati shall pay to Array research funding as set forth and agreed in the Discovery Plan, including all costs of Array in performing the Discovery Program in accordance with the Discovery Plan, but in no case less than [***] Dollars ($[***]) per each full [***] period, or the pro-rata amount thereof corresponding to any period less than [***] if terminated early, during the Discovery Program Term (the “ Minimum Annual Funding ”), payable in accordance with the provisions below.

7.4.1 Payment Schedule . Mirati agrees to pay Array research funding for the conduct of the Discovery Program quarterly, in advance, in the amounts called for in the Discovery Plan for the applicable quarter. The initial payment shall be made before the date Array begins performance of its obligations under the Discovery Plan, and subsequent payments shall be made before the first day of each calendar quarter thereafter. The Discovery Plan shall include a budget and payment schedule setting forth the quarterly amounts to be paid by Mirati to Array. Without limiting Section 5.7.2 above, within [***] after the end of each calendar quarter during the Discovery Program Term, Array shall provide Mirati a report specifying [***] in performing activities under the Discovery Plan during such quarter. Mirati’s Discovery Program payment obligation shall be adjusted as follows: if, at the end of a given year, the actual expenses incurred by Array in performing activities under the Discovery Plan (as set forth in the applicable report required under this Section 7.4.1) during such year, is less than the expenses called for under the Discovery Plan (including without limitation the Minimum Annual Funding) for such period, then the overpayment shall be credited against the next Discovery Program payment due Array under this Agreement. Upon the termination of the Discovery Program, the credit balance corresponding to such overpayments, if any, shall be refunded to Mirati.

7.4.2 No Withholding . All amounts paid by Mirati to Array pursuant to this Section 7.4 shall be made without withholding for taxes or any other charge.

7.4.3 If the amounts payable to Array under this Section 7.4 for any year of the Discovery Program Term are less than the Minimum Annual Funding, then [***].

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7.5 Development Funding . In addition to the funding obligations set forth in Section 7.4, Mirati shall be responsible for all costs and expenses for otherwise developing and commercializing the Active Compounds and Products for use in the Field, including without limitation, preclinical development, clinical development, premarketing and commercial activities.

7.6 Research and Development Milestones . Mirati shall pay to Array the amounts set forth below upon the achievement of each of the corresponding milestones with respect to the applicable Active Compound or Product (each, a “ Development Milestone ”):



Development Milestone	Payment Amount
1. Initiation of GLP toxicology for the first Active Compound	$[***]
2. Initiation of the first Phase I trial for a Product	$[***]
3. Initiation of the first Phase II trial for a Product	$[***]
4. Initiation of the first Phase III trial for a Product	$[***]
5. First Commercial Sale of a Product in US	$[***]
6. First Commercial Sale of a Product in a Major Market in Europe	$[***]
7. First Commercial Sale of a Product in Japan	$[***]

7.6.1 It is understood that Mirati shall be obligated to pay each Development Milestone only once upon the first achievement of the applicable Development Milestone with respect to the first Active Compound or first Product, as applicable, to achieve such Development Milestone. As used in this Agreement, “Major Market” shall mean [***].

7.6.2 Skipped Development Milestones . If Development Milestone 4, 5, 6 or 7 is achieved with respect to a particular Product before Development Milestone 1, 2 or 3 is achieved (each a “prior” Development Milestone), then each such prior Development Milestones shall be deemed achieved upon achievement of Development Milestone 4, 5, 6, or 7 as applicable, and become payable (if not previously paid) in accordance with this Section 7.6.

7.7 Sales Milestones .

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7.7.1 Sales Milestone Payments . Mirati shall pay to Array the amounts set forth below following the achievement of each of the corresponding Net Sales milestones with respect to each Product (each, a “ Sales Milestone ”):



Sales Milestone Event	Payment Amount
1. Upon the first occurrence for each Product achieving Annual Net Sales in the Territory equal to or greater than [*] Dollars (US$[*]):	$[***]
2. Upon the first occurrence for each Product achieving Annual Net Sales in the Territory equal to or greater than [*] Dollars (US$[*]):	$[***]
3. Upon the first occurrence for each Product achieving Annual Net Sales in the Territory equal to or greater than [*] Dollars (US$[*]):	$[***]
4. Upon the first occurrence for each Product achieving Annual Net Sales in the Territory equal to or greater than [*] Dollars (US$[*]):	$[***]

7.7.2 Certain Terms . For purposes of this Section 7.7, all dosages, dosage forms and all formulations of products containing a particular Active Compound, and regardless of delivery mechanism, shall be deemed a single Product, and Mirati shall not be obligated to pay any additional Sales Milestones therefor.

7.8 Milestone Payment Timing; Other Milestone Provisions . Mirati and Array each agree to promptly notify the other of its achievement of any milestone event set forth in Sections 7.6 and 7.7 above and the payment of each corresponding milestone payment set forth in the Section 7.6 or 7.7, as applicable, shall be due and payable by Mirati to Array as follows: (a) for milestones events set out in Section 7.6 or 7.7 above achieved by Mirati, its Affiliate or Sublicensee, Mirati shall notify Array in writing within [***] after the achievement of each such milestone by Mirati, its Affiliate or Sublicensee, and each such notice shall be accompanied by the appropriate milestone payment; and (b) for milestone events set out in Section 7.6 achieved by Array, the appropriate milestone payment shall be due [***] after receipt by Mirati of notification from Array thereof, subject to Mirati’s verification during such [***] period that the applicable milestone event occurred. For the avoidance of doubt, the milestone payments set forth in Sections 7.6 and 7.7 above shall not

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be refundable and shall not be creditable against future milestone payments, royalties or other payments to Array under this Agreement, and notification of achievement of Sales Milestones 1, 2, 3 and 4 and the payments therefor shall be due within [***] after the end of the calendar year in which they were achieved. Royalties .

7.8.1 Royalty Payment . Mirati shall pay Array a percentage royalty on annual Net Sales of Products on a tiered basis at the percentage royalty rate corresponding to the amount of annual Net Sales of Product within each annual Net Sales tier or increment, as follows:



Aggregate Worldwide Annual Net Sales Increment	Royalty Rate on Incremental Net Sales
$[***] and less	[***]%
$[*] to [*]	[***]%
$[*] to $[*]	[***]%
$[***] and more	[***]%

7.8.2 Royalty Term. The royalties due pursuant to this Section 7.9 shall be payable on a country-by-country and Product-by-Product basis until the later of: (a) the date of expiration of the last-to-expire Valid Claim of a Patent within the Collaboration Patent Rights or the Array Background Technology covering such Product in the country in which such Product is sold at the time of such sale; or (b) [***] years after the First Commercial Sale of such Product in such country (the “Royalty Term”).

7.8.3 One Royalty . Only one royalty shall be paid to Array with respect to a particular Product subject to royalties under this Section 7.9, without regard to whether more than one issued and unexpired claim of a Patent within the Collaboration Patent Rights or Array Background Technology is applicable to such Product. In no event shall more than one royalty be due hereunder with respect to any Product unit.

7.8.4 Third Party Obligations; Generic Products .

(a) In the event that (i) Mirati or its Affiliate or its or their Sublicensees determines it reasonably necessary to obtain a license under a Patent of a Third Party, where such

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Patent covers the composition, use or all practical methods of synthesis of an Active Compound contained in the Product or of a Product, and such Patent would necessarily be infringed by the development, manufacture or sale of such Product, and (ii) Mirati must pay such Third Party a running royalty on Net Sales of such Product in a particular country for such license, then the aforementioned royalty payment obligations to Array shall be reduced by the amount of royalties payable to such Third Parties, but in any event in an amount no greater than [***] percent ([***]%) of the amount of such running royalties actually paid to such Third Party with respect to Net Sales of a given Product in a given country, against royalties due Array on Net Sales of such Product in such country. Mirati shall not be entitled to such credit in any country of the Territory in the event the Patents of such Third Party for which such obligations have been incurred are (i) held unpatentable, invalid or unenforceable in a final decision of a court or other government agency of competent jurisdiction from which no appeal may be or has been taken, or (ii) admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise, in such country.

(b) Consultation . Mirati shall consult with Array prior to entering into any license agreement with a Third Party for which Mirati would seek to deduct royalties under this Section 7.9.4, and shall take into account reasonable suggestions of Array with respect to such proposed license, including whether such a license is necessary.

(c) Generic Products . On a Product-by-Product and country-by-country basis, and provided that the Royalty Term has not yet expired, upon (i) the first sale in the applicable jurisdiction of any Generic Product for an indication for which a Product has received Marketing Approval, and (ii) such Generic Product(s) represent a total unit volume of at least [***] percent ([***]%) of the combined unit volume of the Product and such Generic Product(s) for all indications, in the aggregate, in such country in any calendar quarter determined by the number of prescriptions given for the Product and such Generic Product(s), in the aggregate, during such calendar quarter (as measured by IMS data or if IMS data is not available for such country, data from another independent source reasonably agreed upon by the Parties), and Mirati reasonably determines that it is not likely to recover such lost market share; the aforementioned royalty rates shall be reduced by [***] percent ([***]%); provided that in no case will the royalties to be paid to Array be reduced to a rate less than [***] percent ([***]%). For clarity, if the market share of the Generic Product(s) falls below [***] percent ([***]%) in any subsequent calendar quarter, then the reduction shall not apply in such calendar quarter, or any subsequent calendar quarter.

“Generic Product " shall mean a true generic product, i.e., a non-proprietary product containing the same Active Compound being sold hereunder in such country and that: (1) is substantially identical to

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the Product; (2) obtained Marketing Approval solely by means of an Abbreviated New Drug Application filing or a similar procedure for establishing equivalence to such Licensed Product that does not require clinical testing; and (3) is legally marketed in such country by an entity other than Mirati, its Affiliates or its Sublicensees.

7.8.5 Timing of Royalty Payments and Reports . Royalty payments under this Agreement shall be made to Array quarterly within [***] following the end of each calendar quarter for which such royalties are due. Together with any such payment, Mirati shall deliver to Array a report setting out in reasonable detail the information necessary to calculate the royalty payments due under this Section 7.9 for such calendar quarter, including the following information, specified in the aggregate and on a Product-by-Product and country-by-country basis: (a) total gross invoiced amount from sales of Products by Mirati, its Affiliates and Sublicensees; (b) all relevant deductions from gross invoiced amounts to calculate Net Sales; (c) Net Sales; (d) any other deductions or credits permitted in accordance with the terms of this Agreement; and (e) royalties payable.

7.9 Conflicts of Interest . Mirati agrees to establish list prices and discounts for each Product solely in the interest of the commercial success of such Product in a particular country, taking into account the competitive environment, product profile and commercial potential of the Product, and not in the interests of Mirati’s other products and services. However, the foregoing shall not be construed to dictate to Mirati any resale prices for Products.

ARTICLE VIII

PAYMENTS; BOOKS AND RECORDS

8.1 Payment Method . Unless otherwise expressly stated in this Agreement, all payments due under this Agreement shall be made from a bank located in the United States by bank wire transfer in immediately available funds to a bank account designated by Array. All payments hereunder shall be made in U.S. dollars. In the event that the due date of any payment subject to Article 7 hereof is a Saturday, Sunday or national holiday, such payment may be paid on the following business day. Any payments that are not paid on the date such payments are due under this Agreement shall bear interest to the extent permitted by applicable law at the prime rate as reported by the The Wall Street Journal (U.S., Eastern Edition) on the date such payment is due, plus an additional [***] percent ([***]%), calculated on the number of days such payment is delinquent.

8.2 Foreign Exchange . Unless otherwise expressly stated in this Agreement, all amounts specified in, and all payments made under, this Agreement shall be in United States Dollars. If any

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currency conversion shall be required in connection with the calculation of amounts payable under this Agreement, such conversion shall be made using the average of the daily buying and selling exchange rates for conversion of the applicable foreign currency into United States Dollars, quoted for current transactions reported in The Wall Street Journal (U.S., Eastern Edition) for the last [***] of the calendar quarter to which such payment pertains.

8.3 Taxes . If applicable law requires that income or similar taxes be deducted and withheld from royalties or other payments paid under this Agreement, all payments required to be paid to Array pursuant to this Agreement shall be paid with deduction for withholding or similar governmental charge imposed by a jurisdiction other than the United States (“ Withholding Taxes ”), and Mirati shall timely pay all such Withholding Taxes to the applicable tax authority. Mirati shall provide Array a certificate evidencing payment of any Withholding Taxes hereunder. Each Party agrees to cooperate with the other Party in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect. The Parties shall discuss applicable mechanisms for minimizing such taxes to the extent possible in compliance with applicable laws.

8.4 Records . Mirati shall keep, and shall cause its Affiliates and Sublicensees to keep, complete, true and accurate books of accounts and records, in accordance with GAAP and sufficient to determine and establish the amounts payable to Array under this Agreement, and compliance with the other terms and conditions of this Agreement. Such books and records shall be kept at the principal place of business for a Party for at least [***] following the end of the calendar quarter to which they pertain and shall be made available for inspection throughout such [***] period by an independent Third Party auditor selected by or under authority of Array for such purposes in accordance with Section 8.5 below.

8.5 Inspection of Records . Upon no less than [***] written notice by Array to Mirati, Mirati shall permit, and shall require its Affiliates and Sublicensees to permit, an independent certified public accountant (subject to reasonable obligations of confidentiality to Mirati and its Affiliates and Sublicensees, as applicable), appointed by Array and reasonably acceptable to Mirati and its Affiliates and Sublicensees, as applicable, to inspect the books and records of such party described in Section 8.4 above for the sole purpose of verifying the accuracy of the royalty payments required to be made hereunder; provided that such inspection shall occur during normal business hours and not more often than once per calendar year, unless a material error is discovered in such inspection in which case Array shall have the right to conduct an additional audit in such period. The independent certified public accountant shall report to Array only whether there has been a royalty underpayment or overpayment and, if so, the amount thereof and information related to the determination of such

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amount. Any inspection conducted under this Section 8.5 shall be at the expense of Array, unless such inspection establishes any underpayment of any amount due to Array hereunder by at least [***] percent ([***]%) for any annual period, in which case the full costs of such inspection shall be borne by Mirati. Any underpayment shall be paid by Mirati to Array within [***] with interest on the underpayment at the rate specified in Section 8.1 above from the date such payment was originally due. Any overpayment shall be paid by Array to Mirati within [***] or credited against future royalties due, at Array’s sole discretion.

ARTICLE IX
COMMERCIALIZATION

9.1 Commercialization of Products .

9.1.1 Mirati Responsibility . Except with respect to conduct of the Feasibility Program and Discovery Program, Mirati shall have sole responsibility for the development, commercialization, distribution, marketing and promotion of Products.

9.1.2 Diligence .

(a) General . Mirati shall use Commercially Reasonable Efforts to develop and achieve Marketing Approval for, and launch at least one Product as soon as practicable in the United States and Europe, and thereafter to market, promote and sell such Product and to maximize Net Sales of such Product in such markets. Without limiting the foregoing, Mirati shall develop and commercialize Products solely in the interest of the commercial success of such Products in a particular country, taking into account the competitive environment, product profile and commercial potential of such Products, and not in the interests of Mirati’s other products and services.

(b) Reports . After conclusion of the Discovery Program and until the First Commercial Sale of each Product by or on behalf of Mirati hereunder, Mirati shall keep Array apprised of the status of the pre-clinical, clinical and commercial development of such Product (and the Active Compound from which such Product is being developed) by providing Array with [***] updates by phone, video-conference or email and a [***] written reports containing a reasonably detailed summary of such activities with respect to each applicable Product (and the Active Compound from which such Product is being developed) during the prior year, together with all material correspondence with the FDA or similar regulatory agencies concerning such Product (or the Active Compound from which such Product is being developed). The [***] written reports described in this Section 9.1.2(b) shall contain sufficient information to allow Array to monitor Mirati’s

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compliance with this Agreement, including Mirati’s obligations with respect to accomplishment of the Development Milestones and Sales Milestones set forth in Sections 7.6 and 7.7. All reports and information provided under this Section 9.1.2(b) shall be deemed Confidential Information of Mirati.

(c) Meetings . After conclusion of the Discovery Program, [***], on a date and time mutually agreed by the Parties, Array may, at its option, send at least one (1) Array representative, at Array’s cost, to meet with the Mirati product team(s) responsible for the development and regulatory activities for each Active Compound and its corresponding Product and to discuss the conduct and progress of, and plans for, the development and regulatory affairs with respect to such Active Compound and its corresponding Product. In addition, and without limiting Mirati’s reporting obligations under any other provision of this Agreement, Mirati, at its sole discretion, shall provide Array with such information as Array may reasonably request from time to time to pertaining to each Active Compound and its corresponding Product, which, for illustrative purposes, may include, at Mirati’s sole discretion, the following categories: (i) clinical studies; (ii) summaries of clinical study results; (iii) schedules of meetings planned with regulatory agencies; (iv) summaries of key CMC issues, including manufacturing and formulation; (v) prior notice of the initiation of clinical trials; and (vi) prior notice of public communication of clinical results. All reports and information provided to Array under this Section 9.1.2(c) shall be deemed Confidential Information of Mirati.

ARTICLE X

OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS

10.1 Materials .

10.1.1 Ownership . Except as otherwise expressly provided herein, as between the Parties, all right, title and interest in and to all transferred materials, including any compounds and chemical scaffold information provided by one Party to the other hereunder, (and any intellectual property rights relating thereto) shall remain in the Party transferring such materials to the other Party.

10.1.2 Use; Transfer . Each Party agrees that, except as otherwise expressly provided herein, it shall use the other Party’s materials only in connection with activities conducted pursuant to this Agreement or in order to further the purposes of this Agreement, and shall not transfer such materials of the other Party to any Third Party without such other Party’s prior written consent, which consent will not be unreasonably withheld with respect to transfer of the other Party’s materials

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received hereunder to any Third Party in connection with performance of obligations under this Agreement during the Feasibility Program or Discovery Program.

10.2 Ownership of Inventions . As between Array and Mirati, title to all inventions and other intellectual property made solely by employees of Array or jointly by employees of Array with Third Parties in the course of performing, or in connection with, the Feasibility Program or the Discovery Program shall be owned by Array; title to all inventions and other intellectual property made soley by employees of Mirati or jointly by employees of Mirati with Third Parties in the course of performing, or in connection with, the Feasibility Program or the Discovery Program shall be owned by Mirati; and title to all inventions and other intellectual property made jointly by employees of Mirati and Array or jointly by employees of each of Mirati and Array together with Third Parties in the course of performing, or in connection with, the Feasibility Program or Discovery Program shall be owned jointly by Mirati and Array. Inventorship of inventions and other intellectual property made pursuant to this Agreement shall be determined in accordance with the patent laws of the United States. Except as expressly provided in this Agreement, neither Party shall have any obligation to account to the other for profits, or to obtain any approval of the other Party to license or exploit patented jointly-owned subject matter, by reason of joint ownership thereof, and each Party hereby waives any right it may have under the laws of any jurisdiction to require any such consent or accounting.

10.3 Assignment; Cooperation . Each Party shall require all of its employees and any Third Parties working pursuant to this Agreement on its behalf, to assign to such Party any Collaboration Technology discovered, conceived or reduced to practice by such employee or Third Party, and to cooperate with such Party in connection with obtaining Patent protection therefor. The Parties agree to reasonably cooperate with each other to effectuate ownership of Collaboration Technology as set forth herein, including, but not limited to, by executing and recording documents. Each Party shall promptly disclose to the other any inventions made in connection with its activities conducted pursuant to the Feasibility Program or the Discovery Program under this Agreement.

10.4 Patent Prosecution .

10.4.1 Collaboration Technology . (A) Prior to Option Exercise . Prior to exercise of the Option by Mirati, each Party (the “Responsible Party”) shall be responsible, at its expense, for (i) preparing, filing, prosecuting and maintaining Patent applications and Patents directed to Collaboration Technology solely owned by it hereunder, and (ii) for conducting any interferences, re-examinations, reissues and oppositions relating thereto. Each Responsible Party shall keep the other Party informed as to material developments with respect to such activities, including without

limitation, by providing copies of any substantive documents that Responsible Party receives from any patent office, including notice of all interferences, reissues, re-examinations, oppositions or requests for patent term extensions, and by providing the other Party the opportunity to have reasonable input into the strategic aspects of such activities. Responsible Party shall not discontinue prosecution of any such Patent applications or maintenance of any issued Patent without the other Party’s prior written consent. Responsible Party shall keep the other Party reasonably informed with respect to (i) the issuance of Patents obtained by the Responsible Party hereunder, and (ii) the abandonment of any Patents or Patent applications abandoned in accordance with the terms herein. With respect to Collaboration Technology jointly owned by the Parties, the Parties shall agree in writing on which Party will be the Responsible Party for purposes of prosecuting Patent applications and maintaining Patents; upon such agreement, the Responsible Party shall thereafter assume responsibility for prosecuting Patent applications and maintaining Patents in accoradance with the preceding provisions. (B) After Option Exercise . After exercise of the Option, Mirati shall be responsible, at its expense, for (i) preparing, filing, prosecuting and maintaining Collaboration Patent Rights, and (ii) for conducting any interferences, re-examinations, reissues and oppositions relating thereto. Mirati shall keep Array informed as to material developments with respect to such activities, including without limitation, by providing copies of any substantive documents that Mirati receives from any patent office, including notice of all interferences, reissues, re-examinations, oppositions or requests for patent term extensions, and by providing Array the opportunity to have reasonable input into the strategic aspects of such activities. Mirati may elect, at its sole discretion, to discontinue prosecution of any such patent applications and/or not to file or conduct any further activities with respect to such patent applications or patents. Mirati shall keep Array reasonably informed with respect to (i) the issuance of patents filed by Mirati pursuant to this Section 10.4.1(B) and (ii) the abandonment of any patent or patent application maintained by Mirati pursuant to this Section 10.4.1(B).

10.4.2 Other Technology . Except as provided in Section 10.4.1 with respect to Collaboration Technology, each Party shall be responsible, at its own expense and in its sole discretion, for preparing, filing, prosecuting and maintaining, in such countries as it deems appropriate, any and all Patent applications and Patents directed to inventions owned or controlled by such Party and conducting any interferences, re-examinations, reissues and oppositions relating to such Patent applications and Patents.

10.4.3 Cooperation . Array and Mirtati shall reasonably cooperate with each other and assist the other in connection with the activities of Responsible Party or Mirati, as the case may be,

under Section 10.4.1 upon the reasonable request of the Responsible Party or Mirati, respectively, including without limitation by making scientists and scientific records reasonably available to the Responsible Party or Mirati, respectively, and the execution of all such documents and instruments and the performance of such acts as may be reasonably necessary in order to permit Responsible Party or Mirati, respectively, to continue any filing, prosecution, maintenance or extension of such Patents and Patent applications. The Responsible Party shall reimburse the other Party for the other Party’s out of pocket expenses incurred in connection with providing cooperation and assistance with respect to prosecution and maintenance of Patent applications and Patents under Section 10.4.1(A) above, and Mirati shall reimburse Array for Array’s out of pocket expenses incurred in connection with providing cooperation and assistance with respect to prosecution and maintenance of Patent applications and Patents under Section 10.4.1(B) above.

10.5 Enforcement and Defense .

10.5.1 Notice . Each Party shall promptly notify the other of any knowledge it acquires of any potential infringement of the Collaboration Technology by a Third Party.

10.5.2 After the exercise of the Option, if any Patent Right within the Collaboration Technology is infringed by a Third Party in any country in connection with the manufacture, use and/or sale of a product the same as or substantially similar to a Product in the Field in such country, Mirati shall have the primary right, but not the obligation, to institute, prosecute, and control any action or proceeding with respect to such infringement of such Patent Right, by counsel of its own choice, and Array shall have the right, at its own expense, to be represented in that action by counsel of its own choice. If Mirati fails to bring an action or proceeding within a period of [***] after a request by Array to do so, Array shall have the right to bring and control any such action by counsel of its own choice, and Mirati shall have the right to be represented in any such action by counsel of its own choice at its own expense.

10.5.3 If one Party brings an action or proceeding in accordance with Section 10.5.2, the second Party agrees to be joined as a party plaintiff if necessary and to give the first Party reasonable assistance and authority to file and prosecute the suit. The costs and expenses of the Party bringing suit under this Section shall be borne by such Party, and any damages or other monetary awards recovered shall be allocated as follows: The amount of such recovery actually received by the Party controlling such action shall first be applied to the out-of-pocket costs of such action, and then the remaining portion of such recovery [***]. A settlement or consent judgment or other voluntary final disposition of a suit under this

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Section 10.5 may be entered into without the consent of the Party not bringing the suit. Neither Party shall, however, have the right to enter into any settlement or consent to any claim to the effect that the Patent protection offered under any part of the Collaboration Technology would be materially negatively affected, without the consent of the other Party, such consent not to be unreasonably withheld.

10.5.4 For any other infringement or declaratory judgment actions relating to Collaboration Technology falling outside of the application of Section 10.5.2, (i) Mirati shall have the sole right, but not the obligation, to take reasonable legal action relating to any Patent filed by Mirati pursuant to Section 10.4.1 or 10.4.2, at its sole cost and expense, and (ii) Array shall have the sole right, but not the obligation, to take reasonable legal action relating to any Patent filed by Array pursuant to Section 10.4.1 or 10.4.2, at its sole cost and expense. Each Party agrees to render such reasonable assistance as the enforcing Party may request, at the enforcing Party’s expense, with respect to actions brought pursuant to this Section 10.5.4. The costs in bringing any such action shall be paid by, and all recoveries therefrom belong to, the Party bringing such action.

10.6 Patent Marking . Mirati shall mark (or caused to be marked) all Products marketed and sold hereunder with appropriate Patent Rights numbers or indicia at Array’s request to the extent permitted by law, in those countries in which such notices impact recoveries of damages or remedies available with respect to infringements of Patents.

ARTICLE XI
CONFIDENTIALITY

11.1 Confidentiality; Exceptions . Except as otherwise expressly provided herein, the Parties agree that, for the term of this Agreement and for ten (10) years thereafter, the receiving Party shall not, except as expressly provided in this Article 11, disclose to any Third Party, and Array shall not disclose to any Affiliate, or use for any purpose any Confidential Information furnished to it by the disclosing Party hereto pursuant to this Agreement, or any results of the Feasibility Program or Discovery Program (“ Results ”); provided, however, that if Mirati does not exercise the Option during the Option Term, then all Results of the Feasibility Program shall be deemed solely Array Confidential Information and not Mirati Confidential Information (and not subject to the exclusions under Section 11.1.1). For purposes of this Article 11, “ Confidential Information ” shall mean any Information, samples or other materials, which if disclosed in tangible form is marked “confidential” or with other similar designation to indicate its confidential or proprietary nature, or, if disclosed orally, is indicated orally to be confidential or proprietary at the time of such disclosure and is confirmed in writing as

confidential or proprietary within forty-five (45) days after such disclosure. Notwithstanding the foregoing, Confidential Information shall not include any information that can be established by the receiving Party by competent proof:

11.1.1 was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure;

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

11.1.3 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;

11.1.4 was independently developed by the receiving Party as demonstrated by documented evidence prepared contemporaneously with such independent development; or

11.1.5 was disclosed to the receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the disclosing Party not to disclose such information to others.

11.2 Permitted Use and Disclosures . Each Party hereto may use or disclose Confidential Information disclosed to it by the other Party or the Results to the extent such use or disclosure is reasonably necessary in: (a) the exercise of the rights granted hereunder in filing or prosecuting patent applications, prosecuting or defending litigation, complying with applicable governmental laws, regulations or court order or otherwise submitting information to tax or other governmental authorities, (b) conducting clinical trials, offering or making a permitted sublicense or otherwise exercising license rights expressly granted by the other Party to it pursuant to the terms of this Agreement, provided that the Third Party recipient is bound by an obligations of confidentiality and non-use substantially similar to those under this Agreement; or (c) discussions with [***], provided that if a Party is required by court order or other legal or administrative proceeding to make any such disclosure, other than pursuant to a confidentiality agreement, it will give reasonable advance notice to the other Party of such disclosure and, save to the extent inappropriate in the case of patent applications, will use its reasonable efforts to secure confidential treatment of such information in consultation with the other Party prior to its disclosure (whether through protective orders or otherwise) and disclose only the minimum necessary to comply

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

with such requirements). If Mirati does not exercise the Option during the Option Term, then Array shall thereafter be entitled to use and disclose the Results generated by Array for any and all purposes, and the restrictions of this Section 11.2 shall no longer apply with respect to such Results.

11.3 Termination of Prior Agreement . This Agreement supersedes the Mutual Non-Disclosure Agreement between the Parties dated [***]. All information exchanged between the Parties under that the Confidentiality Agreement shall be deemed Confidential Information and shall be subject to the terms of this Article 11.

11.4 Nondisclosure of Terms . Each of the Parties hereto agrees not to disclose the terms of this Agreement to any Third Party without the prior written consent of the other Party hereto, which consent shall not be unreasonably withheld, except to such Party’s [***] under circumstances that reasonably ensure the confidentiality thereof, or to the extent required by law.

11.5 Publicity/Use of Name . During the term of this Agreement, neither Party shall use the name, trademark, tradename or logo of the other Party’s, its Affiliates’ or their respective employees in any publicity, promotion, press releases or disclosure relating to this Agreement or its subject matter without the prior consent of the other Party.

11.6 Publications . Neither Party shall publish or present any Information relating to activities conducted in the course of the Feasibility Program or Discovery Program or the Confidential Information of the other Party except with the other Party’s prior written consent. In the event that the other Party consents, the Party proposing to publish or present such Information shall submit in advance to the other Party for its review any proposed publication or presentation at least [***] in advance of draft submission for publication or presentation. The reviewing Party will promptly review such proposed public disclosure and make any objections that it may have to the publication of Information, including without limitation Confidential Information of the reviewing Party contained therein. Should the reviewing Party make an objection to the publication of any such Information or Confidential Information, then the Parties shall discuss the advantages and disadvantages of publishing the same. If the Parties are unable to agree on whether to publish the same, the [***] of Array and Mirati shall reasonably agree on the extent to which the publication of such Information or Confidential Information shall be made.

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ARTICLE XII
REPRESENTATIONS, WARRANTIES AND COVENANTS;
INDEMNIFICATION

12.1 Mirati . Mirati represents and warrants that: (i) it has the legal power, authority and right to enter into this Agreement and to fully perform all of its obligations hereunder; (ii) this Agreement is a legal and valid obligation binding upon it and enforceable in accordance with its terms; (iii) the performance of its obligations hereunder do not conflict with, violate or breach or constitute a default or require any consent under, any contractual obligations of Mirati; and (iv) as of the Effective Date there is no claim or demand of any Third Party pertaining to, or any proceeding that is pending or, to the knowledge of Mirati, threatened, that challenges the rights of Mirati to use the Target or to conduct the Feasibility Program or the Discovery Program.

12.2 Array . Array represents and warrants that: (i) it has the legal power, authority and right to enter into this Agreement and to fully perform all of its obligations hereunder; (ii) this Agreement is a legal and valid obligation binding upon it and enforceable in accordance with its terms; (iii) the performance of its obligations hereunder do not conflict with, violate or breach or constitute a default or require any consent under, any contractual obligations of Array; and (iv) as of the Effective Date there is no claim or demand of any Third Party pertaining to, or any proceeding that is pending or, to the knowledge of Array, threatened, that challenges the rights of Array to use the Target or to conduct the Feasibility Program or the Discovery Program.

12.3 Disclaimer . Mirati and Array specifically disclaim any guarantee that the Feasibility Program or the Discovery Program will be successful, in whole or in part. The failure of the Parties to successfully develop Active Compounds, Clinical Candidates and/or Products will not constitute a breach of any representation or warranty or other obligation under this Agreement. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, ARRAY AND MIRATI MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OR CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE COLLABORATION TECHNOLOGY, LIBRARY COMPOUNDS, ACTIVE COMPOUNDS, CLINICAL CANDIDATES, INFORMATION DISCLOSED HEREUNDER OR PRODUCTS INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF ANY COLLABORATION TECHNOLOGY, PATENTED OR UNPATENTED, OR NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

12.4 Indemnification by Mirati . Mirati agrees to indemnify, defend and hold harmless Array and its Affiliates and their respective directors, officers, employees, agents and their respective successors, heirs and assigns (the “ Array Indemnitees ”) from and against any losses, costs, claims, damages, liabilities or expense (including reasonable attorneys’ and professional fees and other expenses of litigation) (collectively, “ Liabilities ”) arising, directly or indirectly out of or in connection with Third Party claims, suits, actions, demands or judgments, relating to (i) any Active Compounds, Clinical Candidates or Products developed, manufactured, used, sold or otherwise distributed by Mirati, its Affiliates, or Sublicensees, or on their behalf by Third Parties (including, without limitation, product liability and patent infringement claims), and (ii) any breach by Mirati of the representations and warranties made in this Agreement, except, in each case, to the extent such Liabilities result from the negligence or intentional misconduct of Array.

12.5 Indemnification by Array . Array agrees to indemnify, defend and hold harmless Mirati and its Affiliates and their respective directors, officers, employees, agents and their respective successors, heirs and assigns (the “ Mirati Indemnitees ”) from and against any Liabilities arising, directly or indirectly out of or in connection with Third Party claims, suits, actions, demands or judgments, relating to any breach by Array of its representations and warranties made in this Agreement, except to the extent such Liabilities result from the negligence or intentional misconduct of Mirati.

12.6 Indemnification Procedure . A Party that intends to claim indemnification (the “ Indemnitee ”) under this Article 12 shall promptly notify the other Party (the “ Indemnitor ”) in writing of any claim, complaint, suit, proceeding or cause of action with respect to which the Indemnitee intends to claim such indemnification (for purposes of this Section 12.6, each a “ Claim ”), and the Indemnitor shall have sole control of the defense and/or settlement thereof; provided that the Indemnitee shall have the right to participate, at its own expense, with counsel of its own choosing in the defense and/or settlement of such Claim. The indemnification obligations of the Parties under this Article 12 shall not apply to amounts paid in settlement of any Claim if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld or delayed unreasonably. The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any such Claim, if prejudicial to its ability to defend such action, shall relieve such Indemnitor of any liability to the Indemnitee under this Article 12, but the omission so to deliver written notice to the Indemnitor shall not otherwise relieve the Indemnitor of any liability to any Indemnitee under this Article 12. The Indemnitee under this Article 12, and its employees, at the Indemnitor's request and expense, shall provide full information and reasonable assistance to

Indemnitor and its legal representatives with respect to such Claims covered by this indemnification. It is understood that only Mirati or its permitted assignee may claim indemnity under this Article 12 (on its own behalf or on behalf of a Mirati Indemnitee), and other Mirati Indemnitees may not directly claim indemnity hereunder. Likewise, it is understood that only Array may claim indemnity under this Article 12 (on its own behalf or on behalf of an Array Indemnitee), and other Array Indemnitees may not directly claim indemnity hereunder.

ARTICLE XIII
TERM AND TERMINATION

13.1 Term . Unless earlier terminated, this Agreement and the payment obligations under Article 7 will continue in effect, on a Product-by-Product and country-by-country basis until no further payments are due under Section 7.9 (the “ Term ”). Effective upon the expiration (but not earlier termination) of this Agreement, on a Product-by-Product and country-by-country basis, Array hereby grants to Mirati a fully-paid-up, royalty-free license: (i) under Array’s interest in Collaboration Technology to develop, have developed, make, have made, use, sell, have sold, offer for sale and import such Active Compounds and Products, and (ii) under the Array Background Technology to develop, have developed, make, have made, use, sell, have sold, offer for sale and import such Active Compounds and Products, in each case in such country without further payment or consideration to Array.

13.2 Termination For Breach . Either Party to this Agreement may terminate the Feasibility Program or the Discovery Program and this Agreement in the event the other Party hereto shall have materially breached or defaulted in the performance of any of its material obligations hereunder, and such default shall have continued for sixty (60) days after written notice thereof was provided to the breaching Party by the non-breaching Party. Any termination shall become effective at the end of such sixty (60) day period unless the breaching Party (or any other Party on its behalf) has cured any such breach or default prior to the expiration of the sixty (60) day period; provided, however, in the case of a failure to pay any amount due hereunder, such default may be the basis of termination twenty (20) business days following the date that notice of such default was provided to the breaching Party.

13.3 Termination Upon Notice by Mirati . Mirati may terminate this Agreement for convenience upon [***] prior written notice to Array, without liability for any compensation or other payment obligations other than payment for work peformed up to the date of termination, provided that such notice is given not earlier than [***] months after the date that Mirati exercises the Option.

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13.3.2 Mirati may terminate this Agreement upon sixty (60) days’ prior written notice to Array, without liability for any compensation or other payment obligations, if the JAC or Mirati reasonably determines that the Active Compound or Product caused or is likely to cause fatal, life-threatening or other serious adverse safety event that is likely to preclude Marketing Approval, or the termination of such Marketing Approval if already previously granted, in the United States or any Major Market in Europe.

13.4 Termination on Bankruptcy . Either Party may terminate this Agreement, if, at any time, the other Party shall file in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for the appointment of a receiver or trustee of the Party or of substantially all of its assets, or if the other Party proposes a written agreement of composition or extension of substantially all of its debts, or if the other Party shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed within sixty (60) days after the filing thereof, or if the other Party shall propose or be a party to any dissolution or liquidation, unless in connection with such dissolution or liquidation this Agreement is assigned under Section 14.3, or if the other Party shall make an assignment of substantially all of its assets for the benefit of creditors. Notwithstanding the foregoing, the rights and licenses granted to Mirati and to Array under Sections 6.1 and 6.2 above are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101 of the United States Bankruptcy Code. The Parties acknowledge and agree that Mirati and Array, as applicable, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the United States Bankruptcy Code.

13.5 Effect of Termination .

13.5.1 Accrued Rights, Surviving Obligations . Termination, relinquishment or expiration of this Agreement for any reason shall be without prejudice to any obligations which shall have accrued prior to such termination, relinquishment or expiration, including the payment obligations under Article 7 hereof and any and all damages arising from any breach hereunder.

13.5.2 Return of Materials . Subject to Sections 13.5.3 and 13.5.4 below, upon any termination of this Agreement, Mirati and Array shall promptly return to the other all Confidential Information (including, without limitation, all Know-How) received from the other Party, except one copy of which may be retained for archival purposes.

13.5.3 If Mirati terminates this Agreement pursuant to Section 13.3.1 or Array terminates this Agreement pursuant to Section 13.2, then:

(a) all licenses and rights to Mirati under Sections 6.1 and 6.2 shall concurrently terminate, and Mirati and its Affiliates and Sublicensees shall immediately cease all manufacture, development and commercialization of Compounds and Products; and

(b) If Array wishes to continue development of any Compounds and Products, then Mirati shall grant Array an irrevocable, exclusive, royalty-free, sublicensable license under Mirati’s rights and interests in Collaboration Technology to continue such development and to commercialize such Compounds and Products. All Collaboration Know-How provided by Mirati to Array hereunder will be deemed Array Confidential Information and not Mirati Confidential Information (and not subject to the exclusions under Sections 11.1.1-11.1.5). Mirati also will transfer to Array all Marketing Approval Applications and Marketing Approvals for such Compound and Products, and if Array requests, Mirati will assign (to the extent allowed under the applicable agreement) to Array any third party contracts solely related to the Compounds or Products with contract research organizations, contract manufacturers, and the like; and

13.5.4 If Mirati terminates this Agreement pursuant to Section 13.2, then:

(a) all licenses and rights to Mirati under Sections 6.1 and 6.2 shall survive such termination, provided that Mirati’s royalty obligations under Section [7.8.1] shall also survive, but shall be reduced by [***] percent ([***]%) of the amount that would otherwise have been due. All Collaboration Know-How provided by Array to Mirati under this Agreement will be deemed Mirati Confidential Information and not Array Confidential Information (and not subject to the exclusions under Sections 11.1.1-11.1.5); and

(b) Mirati shall have the sole right to prosecute and maintain, and to enforce, all Collaboration Technology Patents.

13.5.5 Survival . Articles 1, 8, 11 (except as provided in Section 13.5) and 14 (except for Sections 14.3.2 and 14.5), and Sections 10.1, 10.2, 10.3, 12.3, 12.4, 12.5, 12.6, 13.5 and 13.6 shall survive the expiration (and any termination) of this Agreement.

13.6 Termination Not Sole Remedy . Termination is not the sole remedy under this Agreement and, whether or not termination is effected, all other remedies will remain available except as agreed to otherwise herein or separately by the Parties in writing.

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ARTICLE XIV
MISCELLANEOUS

14.1 Dispute Resolution . Except for any disagreements that are within the authority of the JAC as provided in Article 2 above, which disagreements shall be resolved in accordance with Section 2.2.4, the Parties agree that any disputes arising with respect to the interpretation, enforcement, termination or invalidity of this Agreement (each, a “ Dispute ”), shall first be presented to the Parties’ respective CEOs or his/her designee for resolution. If each Party’s CEOs or his/her designee cannot resolve such Dispute within [***] or such longer period of time as such CEOs or their respective designees may agree, either Party may initiate legal proceedings with respect thereto. Notwithstanding anything in this Section 14.1 to the contrary, each Party shall each have the right to apply to any court of competent jurisdiction for appropriate interim or provisional relief, as necessary to protect the rights or property of such Party.

14.2 Governing Law . This Agreement and all questions regarding its validity or interpretation, or the performance or breach of this Agreement, shall be governed by and construed and enforced in accordance with the laws of the State of New York, without reference to conflicts of laws principles.

14.3 Assignment .

14.3.1 This Agreement shall not be assignable by either Party to any Third Party hereto without the written consent of the other Party hereto, which consent shall not be unreasonably withheld, except that either Party may assign this Agreement, without the written consent of the other Party, to an entity that acquires all or substantially all of the business or assets of the assigning Party to which this Agreement pertains, whether by merger, acquisition, sale or otherwise, provided that the acquirer assumes this Agreement in writing or by operation of law. In addition, either Party shall have the right to assign this Agreement to an Affiliate upon written notice to the non-assigning Party; provided that: (a) the assigning Party guarantees the performance of this Agreement by such Affiliate; and (b) if the non-assigning Party reasonably believes that such assignment could result in material adverse tax consequences to the non-assigning Party, such assignment shall not be made without the non-assigning Party’s consent. Subject to the foregoing, this Agreement inure to the benefit of each

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Party and its successors and permitted assigns. Any assignment in contravention of this Section 14.3 shall be null and void.

14.3.2 Certain Matters Relating to Acquisitions . In the event (i) Mirati assigns this Agreement to an entity that acquires all or substantially all of the business or assets of Mirati, or (ii) Mirati merges or consolidates or enters into a similar transaction with an entity in which such entity becomes an Affiliate of Mirati (each such event, a “ Subject Transaction ”), and, as a result of the Subject Transaction, Mirati (or its successor) is thereafter [***], Mirati (or its successor) shall so notify Array and [***].

14.4 Compliance with Laws . In exercising their rights and obligations under this Agreement, the Parties shall fully comply in all material respects with the requirements of any and all applicable laws, regulations, rules and orders of any governmental body having jurisdiction over the activities contemplated by this Agreement, including, without limitation, those applicable to the discovery, development, manufacture, distribution, import and export and sale of Products pursuant to this Agreement.

14.5 Force Majeure . If the performance of any part of this Agreement by a Party is prevented, restricted, interfered with or delayed by an occurrence beyond the control of such Party (and which did not occur as a result of such Party’s financial condition, negligence or fault), including fire, earthquake, flood, embargo, power shortage or failure, acts of war or terrorism, insurrection, riot, lockout or other labor disturbance, governmental acts or orders or restrictions, acts of God (for the purposes of this Agreement, a “ force majeure event”), such Party shall, upon giving written notice to the other Party, be excused from such performance to the extent of such prevention, restriction, interference or delay; provided that the affected Party shall use its reasonable efforts to avoid or remove such causes of non-performance and shall continue performance with the utmost dispatch whenever such causes are removed.

14.6 Notices . Unless otherwise agreed by the Parties or specified in this Agreement, all notices required or permitted to be given under this Agreement shall be in writing and shall be sufficient if: (a) personally delivered; (b) sent by registered or certified mail (return receipt requested and postage prepaid); (c) sent by express courier service providing evidence of receipt and postage prepaid where applicable; or (d) sent by electronic mail transmission (receipt verified by the recipient and a copy promptly sent by another permissible method of providing notice described in

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

paragraphs (a), (b) or (c) above), to the address for a Party set forth below, or such other address for a Party as may be specified in writing by like notice:



To Array: Array BioPharma, Inc. [***]	To Mirati: Mirati Therapeutics, Inc. [***]
With a copy to: Array BioPharma Inc. [***]	With a copy to: Mirati Therapeutics, Inc. [***]

Any such notices shall be effective upon receipt by the Party to whom it is addressed, or within [***] of dispatch, whichever is earlier.

14.7 Waiver . Except as otherwise expressly provided in this Agreement, any term of this Agreement may be waived only by a written instrument executed by a duly authorized representative of the Party waiving compliance. The delay or failure of either Party at any time to require performance of any provision of this Agreement shall in no manner affect such Party’s rights at a later time to thereafter enforce such provision. No waiver by either Party of any condition or term in any one or more instances shall be construed as a further or continuing waiver of such condition or term or of another condition or term.

14.8 Severability . If any provision of this Agreement should be held invalid, illegal or unenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions of this Agreement shall remain in full force and effect in such jurisdiction and shall be liberally construed in order to carry out the intentions of the Parties hereto as nearly as may be possible. Such

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such provision in any other jurisdiction.

14.9 Entire Agreement . This Agreement (including the Schedules attached hereto) constitutes the entire agreement between the Parties relating to its subject matter, and supersedes all prior and contemporaneous agreements, representations or understandings, either written or oral, between the Parties with respect to such subject matter. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as set forth herein and therein.

14.10 Modification . No modification, amendment or addition to this Agreement, or any provision hereof, shall be effective unless reduced to writing and signed by a duly authorized representative of each Party. No provision of this Agreement shall be varied, contradicted or explained by any oral agreement, course of dealing or performance or any other matter not set forth in an agreement in writing and signed by a duly authorized representative of each Party.

14.11 Independent Contractors . Nothing contained in this Agreement is intended, or shall be deemed or construed to create any relationship of employer and employee, agent and principal, partnership or joint venture between the Parties. Each Party is an independent contractor. Neither Party shall assume, either directly or indirectly, any liability of or for the other Party. Neither Party shall have any express or implied right or authority to assume or create any obligations on behalf of, or in the name of, the other Party, nor to bind the other Party to any contract, agreement or undertaking with any Third Party.

14.12 Interpretation . The captions to the several Articles and Sections of this Agreement are included only for convenience of reference and shall not in any way affect the construction of, or be taken into consideration in interpreting, this Agreement. In this Agreement: (a) the word “including” shall be deemed to be followed by the phrase “without limitation” or like expression; (b) references to the singular shall include the plural and vice versa; (c) references to masculine, feminine and neuter pronouns and expressions shall be interchangeable; and (d) the words “herein” or “hereunder” relate to this Agreement. Each accounting term used herein that is not specifically defined herein shall have the meaning given to it under GAAP, but only to the extent consistent with its usage and the other definitions in this Agreement.

14.13 Headings . The captions to the several Sections hereof are not a part of this Agreement, but are included merely for convenience of reference and shall not affect its meaning or interpretation.

14.14 Counterparts . This Agreement may be executed in two (2) counterparts, each of which shall be deemed an original, and both of which together shall constitute one and the same instrument.

[Remainder of page intentionally left blank; signature page follows]

IN WITNESS WHEREOF, the Parties have caused this Drug Discovery Collaboration Option Agreement to be executed by their duly authorized representatives as of the date and year first written above.



ARRAY BIOPHARMA INC. By: /s/ David Snitman Name: David Snitman Title: COO Date: October 1, 2014	MIRATI THERAPEUTICS, INC. By: /s/ Mark J. Gergen Name: Mark J. Gergen Title: EVP & COO Date: October 1, 2014

[Signature Page]

Drug Discovery Collaboration Option Agreement

Array BioPharma Inc. and Mirati Therapeutics, Inc.

Schedule 1.1

Active Compound Criteria

“ Active Compound ” shall mean any [***].

[***]

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

SCHEDULE 1.37
Target

[***]

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

SCHEDULE 3.1
Feasibility Program Objectives

[***]

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

SCHEDULE 4.1.2
Clinical Candidate Criteria



PARAMETERS	GOAL
[***]	[***]
[***]	[ *** ]
[***]	[ *** ]
[***]	[***]
[***]	[***]
[***]	[***]
[***]	[***]
[***]	[***]
[***]	[***]
[ *** ]	[***]
[ *** ]	[***]
[***]	[***]
[ *** ]	[***]
[***]	[***]

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

SCHEDULE 4.1.3
Discovery Plan

Mutant K-Ras(G12C) Inhibitor Discovery Work Plan

[***]

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE MIRATI THERAPEUTIC, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO MIRATI THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

Execution Version

FIRST AMENDMENT TO

DRUG DISCOVERY COLLABORATION OPTION AGREEMENT

THIS FIRST AMENDMENT TO THE DRUG DISCOVERY COLLABORATION OPTION AGREEMENT (the “First Amendment”) is made effective as of August 13, 2015 (“ Effective Date ”) by and between Array BioPharma Inc., a Delaware corporation, having its principal offices located at 3200 Walnut, Boulder, CO 80301 (“ Array ”), and Mirati Therapeutics, Inc., a Delaware corporation, having a place of business at 9363 Towne Centre Drive, Suite 200, San Diego, CA 92121 (“ Mirati ”).

BACKGROUND

A. Array and Mirati entered into a DRUG DISCOVERY COLLABORATION OPTION AGREEMENT dated October 1, 2014.

B. Mirati and Array desire to amend the DRUG DISCOVERY COLLABORATION OPTION AGREEMENT date October 1, 2014 as set forth herein.

1. The definition of Active Compound shall be amended to [***] as set forth in the modified Schedule 1.1 attached hereto. Pursuant to Article 3.2 of the DRUG DISCOVERY COLLABORATION OPTION AGREEMENT, the parties hereby agree that [***] and have mutually agreed to [***] as set forth on Schedule 2 attached hereto. Mirati has agreed to [***] consistent with the [***] also included in Schedule 2 hereto at [***] pursuant to Article 1.18 of the DRUG DISCOVERY COLLABORATION OPTION AGREEMENT at US$[***].

All other terms and conditions of the DRUG DISCOVERY COLLABORATION OPTION AGREEMENT shall remain in full force and effect.

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

IN WITNESS WHEREOF, the Parties have caused this First Amendment to be executed by their duly authorized representatives as of the date and year first written above.



ARRAY BIOPHARMA INC. By: ___ /s/ John Moore _________________ Name: __ John Moore __________________ Title: ____ General Counsel _____________ Date: ____ 14 August 2015 ______________	MIRATI THERAPEUTICS, INC. By: __ /s/ Mark J. Gergen __________________ Name: _ Mark J. Gergen _________________ Title: _ EVP + COO ____________________ Date: _ Aug 13, 2015 ____________________

-2-

Schedule 1.1 (amended)

Active Compound Criteria

“ Active Compound ” shall mean [***].

[***]

-3-

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

Schedule 2

[***] Feasibility Program Work

[***]

-4-

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

Execution Version

SECOND AMENDMENT TO

DRUG DISCOVERY COLLABORATION OPTION AGREEMENT

THIS SECOND AMENDMENT TO THE DRUG DISCOVERY COLLABORATION OPTION AGREEMENT (the "Second Amendment") is made effective as of November 9, 2015 ("Effective Date") by and between Array BioPharma Inc., a Delaware corporation, having its principal offices located at 3200 Walnut, Boulder, CO 80301 ("Array"), and Mirati Therapeutics, Inc., a Delaware corporation, having a place of business at 9363 Towne Centre Drive, Suite 200, San Diego, CA 92121 ("Mirati").

BACKGROUND


A.	Array and Mirati are parties to that certain DRUG DISCOVERY COLLABORATION OPTION AGREEMENT dated October 1, 2014, as amended August 14, 2015 (collectively the "Agreement").


B.	On September 28, 2015, Mirati extended the Option Term and Feasibility Program (each as defined in the Agreement) from October 1, 2015 through April 1, 2016 (the "Extension Period").


C.	Mirati and Array agree that, Pursuant to Section 3.2 of the Agreement, [***] the Feasibility Program.

1. The Parties have mutually agreed to [***] as set forth on Schedule 1 attached hereto from the [***] until [***]. Mirati has agreed to [***] consistent with the [***] also included in Schedule

l hereto [***] pursuant to Article 1.18 of the Agreement of US$[***]. Mirati

will be invoiced for the [***] from [***] to [***] and will pay Array within [***] of receiving the related invoice.

All other terms and conditions of the Agreement as amended shall remain in full force and

effect.

[***] = Certain Confidential Information Omitted

IN WITNESS WHEREOF, the Parties have caused this Second Amendment to be executed by their duly authorized representatives as of the date and year first written above.



ARRAY BIOPHARMA INC. By: ___ /s/ John Moore _________________ Name: __ John Moore __________________ Title: ____ General Counsel _____________ Date: ____ 24 Nov 2015 ______________	MIRATI THERAPEUTICS, INC. By: __ /s/ Mark J. Gergen __________________ Name: _ Mark J. Gergen _________________ Title: _ EVP + COO ____________________ Date: _ Nov 24, 2015 ____________________

-2-

Schedule2

[***] Feasibility Program Work

[***]

-4-

[***] = Certain Confidential Information Omitted

THIRD AMENDMENT TO

DRUG DISCOVERY COLLABORATION OPTION AGREEMENT

THIS THIRD AMENDMENT TO THE DRUG DISCOVERY COLLABORATION OPTION AGREEMENT (the "Second Amendment") is made effective as of February 13, 2016 ("Effective Date") by and between Array BioPharma Inc., a Delaware corporation, having its principal offices located at 3200 Walnut, Boulder, CO 80301 ("Array" ), and Mirati Therapeutics, Inc., a Delaware corporation, having a place of business at 9363 Towne Centre Drive, Suite 200, San Diego, CA 92121 ("Mirati" ).

BACKGROUND


A.	Array and Mirati are parties to that certain DRUG DISCOVERY COLLABORATION OPTION AGREEMENT dated October 1, 2014, as amended August 14, 2015 (collectively the "Agreement").


B.	On September 28, 2015 and November 9, 2015, Mirati extended the Option Term and Feasibility Program (each as defined in the Agreement) from October 1, 2015 through April 1, 2016 (the "Extension Period").


C.	Mirati and Array agree that, Pursuant to Section 3.2 of the Agreement, [***] the Feasibility Program.

1. The Parties have mutually agreed to [***] as set forth on Schedule 1 attached hereto from the [***] until [***]. Mirati has agreed to

[***] consistent with the [***] also included in Schedule

1 hereto [***] pursuant to Article 1.18 of the Agreement of US$[***].

Mirati will be invoiced for the [***] from [***] to [***] and must pay Array within [***] of receiving the related invoice.

All other terms and conditions of the Agreement shall remain in full force and effect.

[***] = Certain Confidential Information Omitted

IN WITNESS WHEREOF, the Parties have caused this Second Amendment to be executed by their duly authorized representatives as of the date and year first written above.



ARRAY BIOPHARMA INC. By: ___ /s/ John Moore _________________ Name: __ John Moore __________________ Title: ____ General Counsel _____________ Date: ____ 4 March 2016 ______________	MIRATI THERAPEUTICS, INC. By: __ /s/ Mark J. Gergen __________________ Name: _ Mark J. Gergen _________________ Title: _ EVP + COO ____________________ Date: _ March 3, 2016 ____________________

-2-

Schedule 2

[ *** ] Feasibility Program Work

[ ***]

-4-

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

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AMENDMENT #4 OF

DRUG DISCOVERY COLLABORATION OPTION AGREEMENT

(G12C Agreement)

This Amendment #4 to Drug Discovery Collaboration Option Agreement (the “Amendment #4” ) is entered into effective this 24 ^th day of August, 2018 (the “Amendment Date” ) by and between Mirati Therapeutics, Inc., a Delaware corporation, having its principal offices located at 9393 Towne Centre Drive, Suite 200, San Diego, CA 92121 (herein, “Mirati” ) and Array BioPharma Inc. , a Delaware corporation, having its principal offices located at 3200 Walnut, Boulder, CO 80301 (herein, “Array” ). Mirati and Array may be referred to hereinafter individually as a “Party” and collectively as the “Parties.”

Whereas, Mirati and Array are parties to that certain Drug Discovery Collaboration Option Agreement dated October 1, 2014, as amended (herein, the “Agreement” ) directed to the Target (as defined in the Agreement) (i.e., G12C), and further are parties to that certain Drug Discovery Collaboration Option Agreement dated June 7, 2017, as amended (herein, the “G12D Agreement”), directed to K-Ras G12D (herein referred to as the “G12D Target”);

Whereas, Mirati exercised the Option pursuant to the Agreement effective as of April 1, 2016; and

Whereas, Mirati and Array desire to amend the Agreement to provide to each Party non-exclusive licenses under the Collaboration Technology with respect to the development, manufacture and commercialization of compounds and products [***] Non-Exclusive Targets (as defined herein); and

Whereas, Mirati and Array desire to amend the Agreement with respect to the rights of each Party in the event of termination of the Agreement;

Now, Therefore, in consideration of the foregoing premises and the mutual covenants set forth below, and for other good and valuable consideration, receipt of which is hereby acknowledged, Mirati and Array hereby agree as follows:


1.	Definitions (Generally) . Any capitalized terms used and defined herein shall have the meaning ascribed to such terms herein, and any capitalized terms used but not defined herein shall have the meaning ascribed to such terms in the Agreement.


2.	Section 1.41 (Additional Definitions) . Section 1.41 (Additional Definitions) of the Agreement is amended by adding the following defined terms to the Agreement:

“Development Documents” shall mean all documents in Mirati’s possession or otherwise owned by Mirati to the extent containing or reflecting Information, other than Collaboration Know-How, that pertain specifically to Active Compound and/or Product and are generated or obtained by Mirati directly in the course of its performance of the Agreement, which include without limitation data pertaining to clinical samples (tissue, blood, PK samples or extracts from biological samples) obtained from trial participants and/or to any Mirati-developed diagnostic test that may be required to pursue ongoing development or regulatory submissions,

[***] = Certain Confidential Information Omitted

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regulatory correspondence with health authorities, investigator financial disclosures, protocols and protocol amendments, clinical study reports including all tables, listings and figures, investigator brochures, trial master files, case report forms, clinical and safety data bases, analysis data sets, site monitoring and audit reports, records of health authority inspections, clinical pharmacology reports, data pertaining to tissue samples used for translational studies or to blood or plasma samples collected for translational, PK or diagnostic co-development, collected ECG, imaging studies and outputs from other specialized diagnostic tests in any available format and, to the extent permissible under applicable Third Party agreement(s), access to any such Information generated and/or controlled by Third Party vendors or collaborators pertaining specifically to the clinical development of Active Compound and/or Product.

“ Non-Exclusive Compound ” shall mean a chemical entity or compound that [***] a Non-Exclusive Target, but for clarity excludes any chemical entity or compound that also [***]: (i) the Target (as defined in the Agreement) at a potency of [***] or greater (i.e., less than or equal to [***] concentration; IC50 values), or (ii) the G12D Target at a potency of [***] or greater (i.e., less than or equal to [***] concentration; IC50 values), in each case (i) or (ii) above in an appropriate Target-specific or G12D Target-specific, respectively, [***].

“ Non-Exclusive Product ” shall mean any pharmaceutical product for use in the Field that incorporates as an active ingredient, solely or in combination with other active ingredients, a Non-Exclusive Compound.”

“ Non-Exclusive Target ” shall mean any target other than the Target (as defined in the Agreement) or the G12D Target.


3.	Article VI (License Grants; Exclusivity) .


(a)	Article VI (License Grants; Exclusivity) is hereby amended as follows:

(i) Section 6.2.1 is hereby amended to add the following sentence at the end of such Section 6.2.1:

“For clarity, the exclusivity contemplated by this Section 6.2.1 shall not be interpreted to limit Array’s ability to exercise rights granted under Section 6.7 of this Agreement, in accordance with and subject to the limitations contained in such Section 6.7.”

(ii) Section 6.5 is hereby amended by adding the following sentence at the end of Section 6.5:

“For clarity, the Parties acknowledge and agree that, notwithstanding the provisions of this Section 6.5, the applicable Party is entitled to exercise the rights granted to such Party in Section 6.6 or Section 6.7 (as applicable) with respect to any Non-Exclusive Compounds

[***] = Certain Confidential Information Omitted

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and Non-Exclusive Products, but solely in accordance with and subject to the limitations set forth in such applicable Section.”

(iii) New Sections 6.6 and 6.7 are hereby added to the Agreement immediately after Section 6.5, as set forth below:

“6.6 Non-Exclusive License Grant to Mirati . Array hereby grants to Mirati and its Affiliates a non-exclusive, worldwide, royalty-free, perpetual, irrevocable license, with full rights to grant sublicenses through multiple tiers, under Array’s rights under the Collaboration Technology: (i) to research, develop, have developed, make, have made, use, sell, have sold, offer for sale and import Non-Exclusive Compounds and Non-Exclusive Products and (ii) to research (but not to develop, have developed, sell, have sold, offer for sale, import or otherwise commercialize, or to make or have made except for purposes of such research) any compound (for clarity, other than Non-Exclusive Compounds) that [***] a Non-Exclusive Target so long as the purpose of such research is solely and exclusively to identify Non-Exclusive Compounds for purposes of exercising its rights pursuant to the license in the immediately preceding clause (i). Notwithstanding any provision in the Agreement to the contrary, nothing in the Agreement shall limit Mirati’s right or ability to research, develop, make and commercialize any Non-Exclusive Compounds and Non-Exclusive Products.

“6.7 Non-Exclusive License Grant to Array . Mirati hereby grants to Array and its Affiliates a non-exclusive, worldwide, royalty-free, perpetual, irrevocable license, with full rights to grant sublicenses through multiple tiers, under Mirati’s rights under the Collaboration Technology: (i) to research, develop, have developed, make, have made, use, sell, have sold, offer for sale and import Non-Exclusive Compounds and Non-Exclusive Products, and (ii) to research (but not to develop, have developed, sell, have sold, offer for sale, import or otherwise commercialize, or to make or have made except for purposes of such research) any compound (for clarity, other than Non-Exclusive Compounds) that [***] a Non-Exclusive Target so long as the purpose of such research is solely and exclusively to identify Non-Exclusive Compounds for purposes of exercising its rights pursuant to the license in the immediately preceding clause (i), but in each case (i) and (ii) above subject to the following limitations. Notwithstanding any provision in the Agreement to the contrary, nothing in the Agreement shall limit Array’s right or ability to research, develop, make and commercialize any Non-Exclusive Compounds or Non-Exclusive Products; except that, the license grant to Array in this Section 6.7 does not include any rights to use or practice Collaboration Technology: (a) with respect to the development, manufacture or commercialization of any chemical entity or compound that [***] the Target or the G12D Target and is for the purpose of treating a patient’s disease or tumor that is positive for the Target or the G12D Target, (b) with respect to the development, manufacture or commercialization of any Compound and/or Product other than a Non-Exclusive Compound or Non-Exclusive Product, and (c) with respect to the development, manufacture or commercialization of any Combination Product and other pharmaceutical products incorporating two or more therapeutically active ingredients and including as one of its active ingredients any chemical entity or compound that [***] the Target

[***] = Certain Confidential Information Omitted

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or the G12D Target and is for the purpose of treating a patient’s disease or tumor that is positive for the Target or the G12D Target.”

(b)

For clarity, (i) without limiting the amendments contemplated in subpart (a) above, the Parties agree that any Information or intellectual property resulting from a Party’s work or activities specifically performed or oriented to identify, discover, research or develop a Non-Exclusive Compound or Non-Exclusive Product shall not be deemed Collaboration Technology, (ii) Array shall not in any event conduct, participate in, or fund, directly or indirectly, alone or with any Affiliate or any Third Party, any activities that are directed to the discovery, development, or commercialization of any chemical entity or compound that [***] the Target or the G12D Target and is for the purpose of treating a patient’s disease or tumor that is positive for the Target or the G12D Target; and (iii) (x) Mirati shall not in any event conduct, participate in, or fund, directly or indirectly, alone or with any Affiliate or any Third Party, any activities outside of this Agreement, other than in connection with the performance of its obligations or exercise of its rights under this Agreement, or the G12D Agreement, respectively, with respect to Active Compounds and Products (as such terms are defined in the Agreement or G12D Agreement, as applicable), that are directed to the discovery, development, or commercialization of any chemical entity or compound that [***] the Target or the G12D Target and is for the purpose of treating a patient’s disease or tumor that is positive for the Target or the G12D Target, provided however that this section shall not be interpreted to limit Mirati’s ability to exercise rights granted under Section 6.6 of this Agreement, in accordance with and subject to the limitations contained in such Section 6.6, and (y) for the avoidance of doubt, no Non-Exclusive Compound shall be used by Mirati, directly or indirectly, alone or with any Affiliate or any Third Party, to develop or commercialize a pharmaceutical product that [***] the Target or the G12D Target and is for the purpose of treating a patient’s disease or tumor that is positive for the Target or the G12D Target.


4.	Sections 7.8.1-7.8.5 (Royalties) .


(a)	Section 7.8.2 (Royalty Term). Section 7.8.2 (Royalty Term) of the Agreement is hereby replaced in its entirety with the following:

“7.8.2 Royalty Term . The royalties due as calculated based upon worldwide annual Net Sales of Product as described in Section 7.8.1 shall be payable on a country-by-country and product-by-product basis until the later of: (a) the date of expiration of the last-to-expire Valid Claim of a Patent within the Collaboration Patent Rights or the Array Background Technology covering such Product in the country in which such Product is sold at the time of such sale; or (b) [***] years after the First Commercial Sale of such Product in such country (the “Royalty Term”).”


(b)	Sections 7.8.3 - 7.8.5 . All references to Section 7.9 in Sections 7.8.3 - 7.8.5 are deemed to be references to Section 7.8.

[***] = Certain Confidential Information Omitted

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5.	Section 13.1 (Term) . The reference to Section 7.9 in Section 13.1 is deemed to be reference to Section 7.8.


6.	Section 13.5.3 .


(a)	Section 13.5.3 (1 ^st Clause) . The first clause of Section 13.5.3 of the Agreement is hereby replaced in its entirety with the following:

“13.5.3 If Mirati terminates this Agreement pursuant to Section 13.3 or Array terminates this Agreement pursuant to Section 13.2, then:”


(b)	Section 13.5.3(a) . Section 13.5.3(a) of the Agreement is hereby replaced in its entirety with the following:

“(a) all licenses and rights to Mirati under Sections 6.1 and 6.2 shall concurrently terminate, and Mirati and its Affiliates and Sublicensees shall immediately cease all manufacture, development and commercialization of Active Compounds and Products; provided however that this section shall not be interpreted to limit Mirati’s ability to exercise rights granted under Section 6.6 of this Agreement, in accordance with and subject to the limitations contained in such Section 6.6; and”


(c)	Section 13.5.3(b) . Section 13.5.3(b) of the Agreement is hereby replaced in its entirety with the following:

“(b) If Array wishes to continue development of any Active Compounds and Products, then Mirati shall grant Array, subject to Section 6.6, an irrevocable, exclusive, royalty-free, sublicensable license under Mirati’s rights and interests in Collaboration Technology to continue such development of and to commercialize such Active Compounds and Products. If Array wishes to continue development of any Active Compounds and Products, then: (i) Mirati shall grant Array, subject to Section 6.6, an irrevocable, exclusive, royalty-free, sublicensable license under Mirati’s rights and interests in Development Documents reasonably necessary to continue such development of and to commercialize such Active Compounds and Products, and (ii) upon written request of Array, Mirati shall provide Array with copies of such Development Documents. Subject to the license grant to Array in the preceding clause (i), Mirati hereby retains all rights and interests in and under Development Documents. Finally, Mirati will also (i) transfer to Array all investigational new drug applications, Marketing Approval Applications and Marketing Approvals specifically pertaining to such Active Compounds and Products, and (ii) if Array requests, assign (to the extent allowed under the applicable agreement) to Array any Third Party contracts solely related to Active Compounds or Products with contract research organizations, contract manufacturers, and the like; and”


7.	Section 13.5.5 (Survival ) . Section 13.5.5 (Survival) of the Agreement is hereby replaced in its entirety with the following:

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13.5.5 Survival . Articles 1, 8, 11 (except as provided in Section 13.5) and 14 (except for Sections 14.3.2 and 14.5), and Sections 6.6, 6.7, 10.1, 10.2, 10.3, 12.3, 12.4, 12.5, 12.6, 13.5 and 13.6 shall survive the expiration (and any termination) of this Agreement.”

Entire Agreement and Amendment #4 . This Amendment #4 is deemed incorporated into and made part of the Agreement, and the Agreement (as amended by this Amendment #4) sets forth the entire agreement and understanding of Mirati and Array with respect to the subject matter hereof and thereof. There are no representations, warranties or covenants made or relied upon by the Parties except as expressly set forth in the Agreement as amended by this Amendment #4.


9.	Agreement Otherwise in Effect; Conflicts . Except as otherwise set forth in this Amendment #4, all other provisions of the Agreement remain unchanged and in effect. In the event of any conflict between the terms of this Amendment #4 and the Agreement, the terms of this Amendment #4 shall prevail and control.


10.	Counterparts . This Amendment #4 may be executed in counterparts, each of which shall be deemed an original, and all of which together shall constitute one and the same instrument.

[signature page follows]

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IN WITNESS WHEREOF , Mirati and Array have caused this Amendment #4 to be executed by their duly authorized representatives as of the Amendment Date above.

Mirati Therapeutics, Inc.

By: /s/ Christopher C. LeMasters

Name: Christopher C. LeMasters

Title: EVP and CBO

Array BioPharma Inc.

By: /s/ Ron Squarer

Name: Ron Squarer

Title: CEO

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Exhibit 31.1

CERTIFICATION

I, Charles M. Baum, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Mirati Therapeutics, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(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 the 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 person 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: April 29, 2019	/s/ Charles M. Baum
	Charles M. Baum
	President and Chief Executive Officer
	(Principal Executive Officer)

Exhibit 31.2

CERTIFICATION

I, Jamie A. Donadio, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Mirati Therapeutics, 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: April 29, 2019		/s/ Jamie A. Donadio
		Jamie A. Donadio
		Senior Vice President and Chief Financial Officer
		(Principal Financial Officer)

Exhibit 32.1

CERTIFICATION

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

(Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)

In connection with the Quarterly Report on Form 10-Q of Mirati Therapeutics, Inc. (the “Company”) for the period ended March 31, 2019 , as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Charles M. Baum, the President and Chief Executive Officer, and I, Jamie A. Donadio, the Senior Vice President and Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: April 29, 2019



/s/ Charles M. Baum		/s/ Jamie A. Donadio
Charles M. Baum		Jamie A. Donadio
President and Chief Executive Officer (Principal Executive Officer)		Senior Vice President and Chief Financial Officer (Principal Financial Officer)

The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.