Document
Table of Contents

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, 2018
 
or
 
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)
______________________________________________________
 
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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes 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
¨
 
Accelerated filer
o
Non-accelerated filer
¨
(Do not check if a smaller reporting company)
Smaller reporting company
x
 
 
 
Emerging growth company
x

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. x

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


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 Total shares of common stock outstanding as of the close of business on April 30, 2018:
Class
 
Number of Shares Outstanding
Common Stock, $0.001 par value
 
29,052,131

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MIRATI THERAPEUTICS, INC.
FORM 10-Q
 
TABLE OF CONTENTS
 
PART I. FINANCIAL INFORMATION
 
 
 
 
 
 
 
 
 
 
PART II. OTHER INFORMATION
 
 
 
 
 
 
SIGNATURES


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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, 2018
 
December 31, 2017
 
(Unaudited)
 
 
ASSETS
 

 
 

Current assets
 

 
 

Cash and cash equivalents
$
20,567

 
$
107,703

Short-term investments
128,085

 
43,134

Other current assets
4,421

 
4,922

Total current assets
153,073

 
155,759

Property and equipment, net
484

 
525

Other long-term assets
987

 
962

Total assets
$
154,544

 
$
157,246

LIABILITIES AND STOCKHOLDERS’ EQUITY
 

 
 

Current liabilities
 

 
 

Accounts payable and accrued liabilities
$
15,761

 
$
13,644

Deferred revenue and other current liabilities
249

 

Total current liabilities
16,010

 
13,644

Deferred revenue and other liabilities
693

 
314

Total liabilities
16,703

 
13,958

Commitments and contingencies
 
 
 
Stockholders’ equity
 

 
 

Preferred stock, $0.001 par value, 10,000,000 shares authorized; none issued and outstanding at both March 31, 2018 and December 31, 2017

 

Common stock, $0.001 par value; 100,000,000 shares authorized; 29,025,834 and 28,622,886 issued and outstanding at March 31, 2018 and December 31, 2017, respectively
29

 
29

Additional paid-in capital
603,957

 
594,407

Accumulated other comprehensive income
9,191

 
9,479

Accumulated deficit
(475,336
)
 
(460,627
)
Total stockholders’ equity
137,841

 
143,288

Total liabilities and stockholders’ equity
$
154,544

 
$
157,246


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,
 
2018
 
2017
Revenue
 
 
 
License and collaboration revenues
$
9,467

 
$

Total revenue
9,467

 

Expenses
 
 
 
Research and development
$
19,659

 
$
14,397

General and administrative
5,154

 
3,693

Total operating expenses
24,813

 
18,090

Loss from operations
(15,346
)
 
(18,090
)
Other income, net
637

 
244

Net loss
$
(14,709
)
 
$
(17,846
)
Unrealized gain (loss) on available-for-sale investments
(288
)
 
71

Comprehensive loss
$
(14,997
)
 
$
(17,775
)
Basic and diluted net loss per share
$
(0.51
)
 
$
(0.73
)
Weighted average number of shares used in computing net loss per share, basic and diluted
28,843,578

 
24,383,941



See accompanying notes


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MIRATI THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in thousands)

 
Three Months Ended March 31,
 
2018
 
2017
Operating activities:
 

 
 

Net loss
$
(14,709
)
 
$
(17,846
)
Non-cash adjustments reconciling net loss to operating cash flows:
 

 
 

Depreciation of property and equipment
41

 
45

Amortization of discount or premium on short-term investments
(162
)
 
(71
)
Share-based compensation expense
3,660

 
1,766

Changes in operating assets and liabilities:
 

 
 

Other current assets
502

 
704

Other long-term assets
(25
)
 
710

Accounts payable, accrued liabilities, deferred revenue and other liabilities
2,745

 
(3,540
)
Cash flows used in operating activities
(7,948
)
 
(18,232
)
Investing activities:
 

 
 

Purchases of short-term investments
(102,820
)
 
(63,310
)
Sales and maturities of short-term investments
17,742

 
22,100

Cash flows used in investing activities
(85,078
)
 
(41,210
)
Financing activities:
 

 
 

Proceeds from issuance of common stock, net of issuance costs

 
66,816

Proceeds from exercise of common stock options and warrants
5,890

 

Cash flows provided by financing activities
5,890

 
66,816

Decrease in cash and cash equivalents
(87,136
)
 
7,374

Cash and cash equivalents, beginning of period
107,703

 
22,383

Cash and cash equivalents, end of period
$
20,567

 
$
29,757

 
 
 
 
Supplemental disclosures of non-cash investing activities:
 
 
 
Fixed asset additions included within accounts payable
$

 
$
54



See accompanying notes


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MIRATI THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2018
(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, epigenetic and immunological promoters of cancer. The Company was incorporated under the laws of the State of Delware 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 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, 2017 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, 2017.

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 (loss) 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

Effective January 1, 2017, the Company adopted Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers, using the full retrospective transition method.  As the Company did not have any revenue contracts prior to the first quarter of 2018, an adjustment to prior periods under this method was not applicable. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments.  Under Topic 606, an entity 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 that an entity determines are within the scope of Topic 606, the entity 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 entity satisfies a performance obligation.  The Company only applies the five-step model to contracts when it is probable that the entity 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 footnote 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,
 
2018
 
2017
Common stock options
1,458,774

 

Common stock warrants
11,395,851

 
6,450,612

Total
12,854,625

 
6,450,612


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 May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation, to provide clarity and reduce both 1) diversity in practice and 2) cost and complexity when applying the guidance in Topic 718 to a change in the terms or conditions of a share-based payment award.  ASU 2017-09 provided guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting under Topic 718.  The amendments in ASU 2017-09 were effective for fiscal and interim reporting periods in fiscal years beginning after December 15, 2017.  The amendments in ASU 2017-09 should be applied prospectively to an award modified on or after the adoption date.  Effective January 1, 2018, the

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Company adopted the provisions of ASU 2017-09. The adoption did not have a material impact on the Company's consolidated financial statements or related financial statement disclosure.
    
In January 2016, the FASB issued ASU 2016-01, Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. The new guidance enhanced the reporting model for financial instruments and includes amendments to address aspects of recognition, measurement, presentation and disclosure. The update to the standard was effective for public companies for interim and annual periods beginning after December 15, 2017.  Effective January 1, 2018, the Company adopted the provisions of ASU 2016-01. The adoption did not have a material impact on the Company's consolidated financial statements or related financial statement disclosure.

Recently Issued Accounting Pronouncements

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. The 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. The guidance in ASU 2017-11 is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted, and the guidance is to be applied using a full or modified retrospective approach. The Company does not anticipate that the adoption of ASU 2017-11 will have a material impact on its consolidated financial statements unless a transaction occurs that would need to be evaluated under this guidance at which time the Company will assess the impact of this standard.
    
In February 2016, the FASB issued 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 that a lessee should recognize a liability to make 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 and early adoption is permitted. The Company will adopt ASU 2016-02 in the first quarter of 2019. Although the Company is in the process of evaluating the impact of adoption of the ASU on its consolidated financial statements, the Company currently believes the most significant changes will be related to the recognition of new right-of-use assets and lease liabilities on the Company's balance sheet for real estate operating leases.



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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, 2018
 
Maturity
 
Amortized cost
 
Gross unrealized gains
 
Gross unrealized losses
 
Estimated fair value
Corporate debt securities
2 year or less
 
$
86,479

 
$

 
$
(260
)
 
$
86,219

Commercial paper
1 year or less
 
41,936

 

 
(70
)
 
41,866

 
 
 
$
128,415

 
$

 
$
(330
)
 
$
128,085

 
 
 
As of December 31, 2017
 
Maturity
 
Amortized cost
 
Gross unrealized gains
 
Gross unrealized losses
 
Estimated fair value
Corporate debt securities
1 year or less
 
$
24,264

 
$

 
$
(23
)
 
$
24,241

Commercial paper
1 year or less
 
18,912

 

 
(19
)
 
18,893

 
 
 
$
43,176

 
$

 
$
(42
)
 
$
43,134


Unrealized gains and losses on available-for-sale securities are included as a component of comprehensive loss. At March 31, 2018, 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, 2018
 
Total
 
Level 1
 
Level 2
 
Level 3
Assets
 
 
 
 
 
 
 
Cash and cash equivalents:
 
 
 
 
 
 
 
Cash
$
3,721

 
$
3,721

 
$

 
$

Money market funds
16,846

 
16,846

 

 

Total cash and cash equivalents
20,567

 
20,567

 

 

 
 
 
 
 
 
 
 
Short-term investments:
 
 
 
 
 
 
 
Corporate debt securities
86,219

 

 
86,219

 

Commercial paper
41,866

 

 
41,866

 

Total short-term investments
128,085

 

 
128,085

 

Total
$
148,652

 
$
20,567

 
$
128,085

 
$

 
December 31, 2017
 
Total
 
Level 1
 
Level 2
 
Level 3
Assets
 
 
 
 
 
 
 
Cash and cash equivalents:
 
 
 
 
 
 
 
Cash
$
1,026

 
$
1,026

 
$

 
$

Money market funds
106,677

 
106,677

 

 

Total cash and cash equivalents
107,703

 
107,703

 

 

 
 
 
 
 
 
 
 
Short-term investments:
 
 
 
 
 
 
 
Corporate debt securities
24,241

 

 
24,241

 

Commercial paper
18,893

 

 
18,893

 

Total short-term investments
43,134

 

 
43,134

 

Total
$
150,837

 
$
107,703

 
$
43,134

 
$

    
The Company’s investments in Level 1 assets are valued based on publicly available quoted market prices for identical securities as of March 31, 2018 and December 31, 2017. 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, 2018 or the year ended December 31, 2017.

6. Other current assets and other long-term assets

Other current assets consisted of the following (in thousands):
 
March 31,
 
December 31,
 
2018
 
2017
 

 
 
Prepaid expenses
$
2,693

 
$
3,085

Deposits and other receivables
1,325

 
1,600

Interest receivable
403

 
237

 
$
4,421

 
$
4,922


The other long-term assets balance consisted of $1.0 million in deposits paid in conjunction with the Company's research and development activities at each period March 31, 2018 and December 31, 2017, respectively.


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7. Property and equipment, net

Property and equipment consisted of the following (in thousands):
 
March 31,
 
December 31,
 
2018
 
2017
 
 
 
 
Computer equipment
$
329

 
$
329

Office and other equipment
301

 
301

Laboratory equipment
643

 
643

Leasehold improvements
63

 
63

Gross property and equipment
1,336

 
1,336

Less: Accumulated depreciation
(852
)
 
(811
)
Property and equipment, net
$
484

 
$
525

The Company incurred immaterial depreciation expense for both the three months ended March 31, 2018 and 2017.

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

Accounts payable and accrued liabilities consisted of the following (in thousands):
 
March 31,
 
December 31,
 
2018
 
2017
 
 
 
 
Accounts payable
$
4,731

 
$
4,344

Accrued clinical, development and other expenses
9,058

 
6,279

Accrued compensation and benefits
1,972

 
3,021

 
$
15,761

 
$
13,644

The long-term liabilities balance of $0.7 million as of March 31, 2018 consisted of $0.3 million in deferred revenue and $0.4 million in other liabilities. As of December 31, 2017 the long-term liabilities balance consisted of $0.3 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 Japan and certain other countries), Australia and New Zealand (the “Licensed Territory”). BeiGene is considered a related party as the Company and BeiGene have a common investor. 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 upfront 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.

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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) recognizes revenue when (or as) the Company satisfies 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 license and associated know-how was transferred to BeiGene during the three months ended March 31, 2018, therefore the Company recognized revenue related to this performance obligation in the amount of $9.5 million during the three months ended March 31, 2018. 

Manufacturing Supply Services.  The Company's initial obligation to supply sitravatinb for clinical development in the Licensed Territory represents a distinct performance obligation.  As such, the Company will defer $0.5 million of revenue related to the manufacturing supply services, and will recognize revenue when BeiGene obtains control of the goods, upon delivery, and which is expected to occur in late 2018 and continue into 2020. The Company may also become responsible for manufacturing sitravatinib for clinical and commercial supply and will receive reimbursement that approximates stand-alone selling prices.

Milestone Payments. The Company evaluated whether the milestones are considered probable of being reached and determined that since the milestone payments are not within the control of the Company or BeiGene (due to the requirement for regulatory approvals), the milestones are not considered probable of being achieved, therefore no revenue was recorded related to the milestones at the inception of the Agreement. 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, 2018.

The following table presents a summary of the activity in the Company's contract liabilities during the three months ended March 31, 2018 (in thousands):
 
Balance at Beginning of Period
 
Additions
 
Deductions
 
Balance at End of Period
Contract liabilities:
 
 
 
 
 
 
 
Deferred revenue - current
$

 
$
229

 
$

 
$
229

Deferred revenue - non-current

 
304

 

 
304

Total contract liabilities:
$

 
$
533

 
$

 
$
533

 
 
 
 
 
 
 
 

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10. Warrants 

As of March 31, 2018, 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

 
7,258,263

November 20, 2017
 
None
 
$
0.001

 
4,137,999

 
 
 
 
 
 
11,396,262


During the three months ended March 31, 2018 and 2017, no warrants were exercised.
    

11. Commitments and Contingencies

On June 24, 2014, the Company entered into a lease agreement for 18,000 square feet of 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 that results in the Company recording deferred rent over the term of the lease. 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. This amendment extended the term of the original lease for one year through January 31, 2019. Subsequently, on April 5, 2018, the Company entered into a Second Amendment to Lease Agreement to extend the lease term through January 31, 2020. All other material terms and covenants from the original lease agreement remain unchanged.
    
Future minimum payments required under the lease are summarized as follows (in thousands):
 Year Ending December 31:
2018
$
210

2019
315

2020
26

 Total minimum lease payments
$
551

    


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12. Stockholders' Equity

Share-based Compensation

Total share-based compensation expense by statement of operations classification is presented below (in thousands):
 
Three Months Ended March 31,
 
2018
 
2017
Research and development expense
$
1,493

 
$
982

General and administrative expense
2,167

 
784

 
$
3,660

 
$
1,766

    
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. During the three months ended March 31, 2017, no shares were issued pursuant to stock option exercises.


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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, 2017 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, epigenetic and immunological promoters of cancer. Our precision oncology clinical programs utilize next-generation genomic testing to identify and select cancer patients who are most likely to benefit from targeted drug treatment. In immuno-oncology, we are advancing clinical programs where the ability of our product candidates to improve the immune environment of tumor cells may enhance and expand the efficacy of existing cancer immunotherapy medicines when given in combination. Our preclinical programs 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 pipeline consists of two clinical-stage product candidates: sitravatinib and mocetinostat. We also have a KRAS inhibitor program in preclinical development.
Sitravatinib in Combination with Immune Checkpoint Inhibitors
     Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (“RTKs”), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in a Phase 2 clinical trial in combination with nivolumab (OPDIVO®), Bristol Myers Squibb’s anti-PD-1 checkpoint inhibitor, in patients with non-small cell lung cancer (“NSCLC”) who have experienced documented disease progression following prior treatment with a checkpoint inhibitor. On April 24, 2018 we reported data from this ongoing clinical trial. As of the data cutoff date of March 31, 2018:
23 patients were evaluable for response with at least one radiographic scan;
Six patients achieved a Partial Response ("PR") (four confirmed and two unconfirmed);
Five of the six patients with PRs remain on study, including both patients with unconfirmed PRs; the longest treatment duration exceeds 50 weeks and is ongoing;
The other patient with a PR progressed following a treatment duration that exceeded 40 weeks;
19 of 23 patients demonstrated tumor reductions and
The combination has been well-tolerated, and most adverse events ("AEs") reported by investigators were Grade 1 or 2.

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Additionally, as of April 24, 2018, 45 patients had been enrolled. We expect to present more mature data from this clinical trial at an oncology conference later in 2018. We also expect to meet with regulatory authorities in the second half of 2018 to discuss plans for registration.
Sitravatinib as a Single Agent
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 specific genetic alterations in CBL, CHR4Q12 and RET. In January 2017, we reported early data from this clinical trial. As of December 9, 2016, of the four evaluable patients with RET genetic alterations, there was one patient with stable disease, one unconfirmed partial response and one confirmed partial response. In September 2017, we presented a case study of an NSCLC patient with a CBL inactivating mutation at the IASLC 2017 Chicago Multidisciplinary Symposium in Thoracic Oncology. The case was the first evaluable NSCLC patient harboring a CBL mutation treated in the ongoing Phase 1b study of sitravatinib as a single agent and represents the first example of clinical activity for sitravatinib in a patient with a CBL mutation.
Interim clinical data from the ongoing Phase 1b expansion clinical trial will be presented in a poster at the American Society of Clinical Oncology ("ASCO") Annual Meeting held June 1 - 5, 2018 in Chicago, Illinois. The presentation, titled "Evaluation of the spectrum selective RTK inhibitor sitravatinib in renal cell carcinoma ("RCC") refractory to anti-angiogenic therapy" will report data from patients with RCC treated with single agent sitravatinib. In that same Phase 1b trial of single agent sitravatinib, enrollment continues in the cohorts of patients whose tumors harbor CBL, CHR4Q12 and RET genetic alterations in NSCLC and other tumor types. We plan to present more mature data for the patients in the CBL, CHR4Q12 and RET cohorts at an oncology conference later in 2018.
Sitravatinib Development in Collaboration with BeiGene, Ltd.
In January 2018, we entered into a Collaboration and License Agreement (the “BeiGene Agreement”) with BeiGene, Ltd. (“BeiGene”), pursuant to which Mirati 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, Mirati granted BeiGene an exclusive license to develop, manufacture and commercialize sitravatinib in the Licensed Territory, with Mirati retaining exclusive rights for the development, manufacturing and commercialization of sitravatinib outside the Licensed Territory.
Mocetinostat
Mocetinostat is an oral, Class 1 selective histone deacetylase ("HDAC") inhibitor. Mocetinostat is being evaluated in a Phase 2 clinical trial in combination with durvalumab (IMFINZI™), MedImmune Limited’s anti-PD-L1 checkpoint inhibitor, for the treatment of patients with NSCLC who have experienced disease progression following prior treatment with a checkpoint inhibitor. On April 24, 2018, we reported data from this ongoing clinical trial. As of the data cutoff date of March 31, 2018:
23 patients were evaluable for response with at least one radiographic scan;
Three patients achieved a PR (two confirmed and one unconfirmed);
All three patients with PRs remain on study; the longest treatment duration exceeds 44 weeks and is ongoing;
8 of 23 patients demonstrated tumor reductions and
The combination has been well-tolerated, and most AEs reported by investigators were Grade 1 or 2.
Additionally, as of April 24, 2018, 31 patients had been enrolled. We expect to present more mature data from this clinical trial at an oncology conference later in 2018.
KRAS Inhibitor Program
Our KRAS inhibitor program is focused on the development of MRTX849, an orally-available small molecule. MRTX849 potently and selectively inhibits a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinoma patients and 5% of colorectal cancer patients. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MRTX849 has demonstrated complete regression of KRAS G12C-positive human tumors implanted in mice. Investigational New Drug application ("IND") enabling pre-clinical studies are underway, and we plan to file an IND in the fourth quarter of 2018, and expect early proof-of-concept clinical data in 2019.
Liquidity Overview    
At March 31, 2018, we had $148.7 million of cash, cash equivalents and short-term investments compared to $150.8 million at December 31, 2017. In January 2018 we received an upfront fee of $10.0 million in connection with the BeiGene Agreement. We have not generated any revenue from product sales. To date, we have funded our operations primarily through the sale of our common stock and pre-funded warrants to purchase our common stock and through up-front payments, research funding

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and milestone payments under collaborative arrangements. To fund future operations, we will likely need to raise additional capital as discussed more fully below under the heading "Liquidity and Capital Resources."

Critical Accounting Policies and Significant Judgments and Estimates
Our discussion and analysis of financial condition and results of operations are based upon our 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.
Aside from newly implemented accounting policies related to revenue recognition discussed below, 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, 2017.

Revenue Recognition

Effective January 1, 2017, we adopted Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers, using the full retrospective transition method.  This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments.  Under Topic 606, we recognize revenue when our 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 the BeiGene Agreement, we perform 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 entity satisfies a performance obligation.  We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer.  At contract inception, once the contract is determined to be within the scope of Topic 606, we assess the goods or services promised within each contract, determine those that are performance obligations, and assess whether each promised good or service is distinct.  We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.  We utilize key assumptions to determine a stand-alone selling price for performance obligations, which may include revenue forecasts, expected development timelines, discount rates, probabilities of technical and regulatory success and costs for manufacturing clinical supplies. Because the amount of revenue recognized for each performance obligation is determined based upon its relative stand-alone selling price, an increase or decrease of 10% in the estimated fair value of each performance obligation would not have a significant impact on the amount of revenue recognized.

See footnote 9 of our condensed consolidated financial statements for a complete discussion of the revenue recognition for the BeiGene Agreement.


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Results of Operations

Comparison of the Three Months Ended March 31, 2018 and 2017
The following table summarizes the significant items within our results of operations for the three months ended March 31, 2018 and 2017 (in thousands):
 
Three months ended
March 31,
 
Increase
 
2018
 
2017
 
(Decrease)
License and collaboration revenues
$
9,467

 
$

 
$
9,467

 
 
 
 
 
 
Research and development expenses
$
19,659

 
$
14,397

 
$
5,262

General and administrative expenses
5,154

 
3,693

 
1,461

Other income, net
637

 
244

 
393


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. The BeiGene Agreement became effective January 7, 2018. License and collaboration revenues for the three months ended March 31, 2018 were $9.5 million and relate to the license the Company granted to BeiGene under BeiGene Agreement. As the BeiGene Agreement is the first such license and collaboration agreement for the Company, no license and collaboration revenues were recorded during the three months ended March 31, 2017.

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 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; and
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, mocetinostat and 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 preclinical KRAS inhibitor program, or any of our other preclinical programs, into clinical development, or advancing sitravatinib or mocetinostat into more advanced stages of clinical development.



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Our research and development efforts during the three months ended March 31, 2018 and 2017 were focused primarily on our ongoing oncology programs, sitravatinib and mocetinostat, our glesatinib program (for which development was discontinued in the fourth quarter of 2017) and our preclinical KRAS inhibitor program. The following table summarizes our research and development expenses (in thousands):
 
Three months ended March 31,
 
Increase
 
2018
 
2017
 
(Decrease)
Third-party research and development expenses:
 
 
 
 
 
Clinical development programs:
 
 
 
 
 
Sitravatinib
7,148

 
2,084

 
5,064

Mocetinostat
1,373

 
1,072

 
301

Glesatinib
2,099

 
5,061

 
(2,962
)
Pre-clinical development programs:
 
 
 
 
 
KRAS inhibitor
3,689

 
1,181

 
2,508

Preclinical and early discovery
348

 
974

 
(626
)
Total third-party research and development expenses
14,657

 
10,372

 
4,285

Salaries and other employee related expense
2,790

 
2,510

 
280

Share-based compensation expense
1,493

 
982

 
511

Other research & development costs
719

 
533

 
186

Research and development expense
$
19,659

 
$
14,397

 
$
5,262

Research and development expenses for the three months ended March 31, 2018 were $19.7 million compared to $14.4 million for the three months ended March 31, 2017. The increase of $5.3 million primarily relates to increases in third-party development expense of $4.3 million. The increase in third-party research and development expense relates to an increase in expenses associated with development of sitravatinib of $5.1 million due to the continuation and expansion of ongoing clinical trials. The increase in third-party research and development expense is also due to a $2.5 million increase in expenses related to continued development of our KRAS program due to costs associated with preparing for a planned IND submission for our selected lead clinical compound, MRTX849. These increases are partially offset by a $3.0 million decrease in glesatinib expenses.

General and administrative expenses

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, 2018 and 2017 were $5.2 million and $3.7 million, respectively, an increase of $1.5 million. The increase is primarily due to an increase in share-based compensation expense due to an increase in the fair value of stock options granted during the three months ended March 31, 2018 compared to the three months ended March 31, 2017.

Liquidity and Capital Resources
At March 31, 2018, we had $148.7 million of cash, cash equivalents and short-term investments compared to $150.8 million at December 31, 2017. 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

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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, 2018 and 2017

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,
 
2018
 
2017
Net cash used in operating activities
$
(7,948
)
 
$
(18,232
)
Net cash used in investing activities
(85,078
)
 
(41,210
)
Net cash provided by financing activities
5,890

 
66,816

(Decrease) increase in cash
(87,136
)
 
7,374


Net cash used in operating activities

Net cash used for operating activities for the three months ended March 31, 2018 was $7.9 million, compared to $18.2 million for the three months ended March 31, 2017, a decrease of $10.3 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 of $3.7 million and net cash inflows from a change in our operating assets and liabilities of $3.2 million. Cash used in operating activities during 2017 primarily related to our net loss of $17.8 million, adjusted for non-cash items such as share-based compensation expense of $1.8 million and net cash outflows from a change in our operating assets and liabilities of $2.1 million.

Net cash used in investing activities

For the three months ended March 31, 2018 investing activities used cash of $85.1 million due to purchases of short term investments, offset by maturities of short-term investments. Investing activities for the three months ended March 31, 2017 used cash of $41.2 million as a result of maturities of short-term investments. 

Net cash provided by financing activities

Net cash provided by financing activities for the three months ended March 31, 2018 was $5.9 million and consisted entirely of proceeds received from the exercise of common stock options. Net cash provided by financing activities for the three months ended March 31, 2017 was $66.8 million and consisted of proceeds from the issuance of common stock from our January 2017 public offering of common stock and pre-funded warrants.

Off-Balance Sheet Arrangements

During the three months ended March 31, 2018, 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.

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.


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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 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, 2018, 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 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, 2018, 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, 2018 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

During the quarter ended March 31, 2018, our management implemented certain new internal controls related to the Company's accounting for license and collaboration agreements.

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 other 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, except for the aforementioned change in internal control, our principal executive officer and principal financial officer concluded that there were no other 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, 2017. 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 $19.7 million and $14.4 million for the three months ended March 31, 2018 and 2017, 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 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, 2018 and 2017 was $14.7 million and $17.8 million, respectively. As of March 31, 2018, we had an accumulated deficit of $475.3 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:

completing development and clinical trial programs for our product candidates;

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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.

As an “emerging growth company” (as defined in the JOBS Act), we are not required to comply with Section 404(b) which requires attestation from our external auditors on our internal control over financial reporting. We are subject to Section 404(a), which requires management to provide a report regarding the effectiveness of internal controls. We are required to review all of our control processes to align them to the Section 404 requirements. Failure to provide assurance that our financial controls are effective could lead to lack of confidence by investors which could cause our stock price to decline. When we are no longer an “emerging growth company” (as defined in the Exchange Act or the Securities Act of 1933, as amended (the "Securities Act"), our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting. The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation. To continue complying with the requirements of being a reporting company under the Exchange Act, we may need to further upgrade our systems, including information technology, implement additional financial and management controls, reporting systems and procedures, and hire additional accounting and finance staff.

In addition, our independent registered public accounting firm has never performed an evaluation of our internal control over financial reporting in accordance with the provisions of the Sarbanes-Oxley Act because no such evaluation has been required. Had our independent registered public accounting firm performed an evaluation of our internal control over financial reporting in accordance with the provisions of the Sarbanes-Oxley Act, significant deficiencies or material weaknesses may have been identified. If we identify any significant deficiencies or material weaknesses that may exist or are unable to successfully remediate any significant deficiency or material weakness in our internal control over financial reporting, the accuracy and timing of our financial reporting may be adversely affected, we may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports in addition to applicable stock exchange listing requirements, investors may lose confidence in our financial reporting, and our stock price may decline as a result.

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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.

We are an emerging growth company and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors.

We are an emerging growth company. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

For as long as we continue to be an emerging growth company, we intend to take advantage of certain other exemptions from various reporting requirements that are applicable to other public companies including, but not limited to, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, exemptions from the requirements of holding a nonbinding advisory stockholder vote on executive compensation and any golden parachute payments not previously approved, exemption from the requirement of auditor attestation in the assessment of our internal control over financial reporting and exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board. If we do continue to be an emerging growth company, the information that we provide stockholders may be different than what is available with respect to other public companies. We cannot predict if investors will find our common stock less attractive because we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less-active trading market for our common stock and our stock price may be more volatile.

We expect that we will remain an emerging growth company until December 31, 2018.

Decreased disclosures in our SEC filings due to our status as an emerging growth company may make it harder for investors to analyze our results of operations and financial prospects.

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 up to an additional $123.0 million upon the achievement of certain milestones under the BeiGene Agreement. However, the receipt of 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.

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. We currently have no product candidates beyond Phase 2 clinical trials. Mocetinostat is currently in a Phase 2 combination clinical trial, sitravatinib is in Phase 1b single agent and Phase 2 combination clinical trials and we have a KRAS 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.

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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 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.

Because developing pharmaceutical products, conducting clinical trials, obtaining regulatory approval, establishing manufacturing capabilities and marketing approved products is expensive, 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. We expect that the FDA and comparable foreign regulatory authorities will require the regulatory approval of a companion diagnostic as a condition to approving our product candidates for the selection of patients with tumors expressing specific genetic markers. 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 clinical data management and 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. For example, our product candidate sitravatinib is a targeted therapeutic candidate to treat patients with cancers that are driven by dysregulated receptor tyrosine kinases (“RTK”), specifically tumors that harbor CBL, CHR4Q12 and RET genetic alterations in non-small cell lung cancer ("NSCLC") and other tumor types. These mutations are estimated to be present in a total of 5.5% of all NSCLC patients. The frequency at which the CBL, CHR4Q12 and RET genetic alterations are expressed in certain tumor types may affect our success in enrolling a suitable number of patients to participate in our clinical trials. In addition, some of our competitors have ongoing clinical trials for product candidates that treat the same indications, including NSCLC, where we are studying each of mocetinostat and 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.


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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.

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. 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. 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. 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.

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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.

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:

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, if at all.

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.


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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.

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 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.


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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 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. At the federal level, the Trump Administration’s budget proposal for fiscal year 2019 contains further drug price control measures that could be enacted during the 2019 budget process or in other future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low-income patients. While any proposed measures will require authorization through additional legislation 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 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. President Trump has signed two Executive Orders designed to delay the implementation of certain provisions of the ACA or otherwise circumvent some of the requirements for health insurance mandated by the ACA. Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes under the ACA have been signed into law. The Tax Cuts and Jobs Act of 2017 includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” Additionally, on January 23, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain ACA-mandated fees, including the so-called “Cadillac” tax on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices. Further, the Bipartisan Budget Act of 2018 (the “BBA”) among other things, amends the ACA, effective January 1, 2019, to increase from 50 percent to 70 percent the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D and to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole.” We cannot predict how the ACA, its possible repeal or replacement or other potential future healthcare reform may impact our operations.

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 BBA, 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 new obligations on manufacturers of pharmaceutical products related to product tracking and tracing.

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These new 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.

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: Nektar Therapeutics, Corvus Pharmaceuticals, Inc., Bristol-Myers Squib, Syndax, Inc., Cabometryx (Exelixis, Inc.) Blueprint Medicines, Inc., Roche, Loxo Oncology, Inc., Chroma Therapeutics Ltd., Huya Bioscience International, Shenzen Chipscreen Biosciences Ltd., Celgene Corporation, Curis Inc., MEI Pharma Inc., Merck & Co Inc., and Novartis among others.
 
Many companies have filed, and continue to file, patent applications in oncology which may or could affect our program. 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: Bristol-Myers Squibb Company; Compugen Limited; Exelixis; GlaxoSmithKline PLC; Novartis; Pfizer and Araxes Pharma LLC. 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 HDAC inhibitors or kinase inhibitors addressing oncology indications, 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

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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.

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 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:

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;

federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against 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 civil False Claims Act;

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;

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 covered healthcare providers, health plans, and healthcare clearinghouses, as well as their business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, 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;

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 the Centers for Medicare and Medicaid Services (“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

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-

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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 or marketing expenditures; 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 and regulatory exceptions, 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, individual 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.

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

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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.

*    The recently passed comprehensive tax reform bill could adversely affect our business and financial condition.

On December 22, 2017, President Trump signed into law new legislation that significantly revises the Internal Revenue Code of 1986, as amended. The newly enacted federal income tax law, 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%, 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

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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 new federal tax law 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 newly enacted federal tax law. The impact of this tax reform on holders of our common stock is also uncertain and could be adverse.

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 claims restricted or we may not be able to supply sufficient data to satisfy a patent office to support our claims and, as a result, may not obtain the original claims desired or we may receive restricted claims. Alternatively, it is possible that we may not receive any patent protection from an application.

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.


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Many of our collaboration agreements, including the BeiGene Agreement, 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 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

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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
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.


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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, 2018, our stockholders and their affiliates who owned more than 5% of our outstanding common stock collectively owned 58% of our outstanding common stock. Baker Bros. Advisors, L.L.C. ("Baker Brothers") and Boxer Capital, LLC (“Boxer Capital”) and their affiliates collectively own 27% 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 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.


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

Under Section 382 of the Internal Revenue Code of 1986, as amended ("the Code"), if a corporation undergoes an “ownership change,” 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 U.S. net operating loss carryforwards ("NOLs"), and other pre-change U.S. tax attributes (such as research tax credits) to offset its post-change income may be limited. We experienced an 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, if we earn net taxable income, our ability to use our pre-change U.S. net operating loss carryforwards to offset U.S. federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to us. 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. In addition, under the newly enacted federal income tax law, federal net operating losses incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility of such federal net operating losses is limited. It is uncertain if and to what extent various states will conform to the newly enacted federal tax law.

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

JOBS Act         

In April 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other companies. We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions, including without limitation with respect to, (1) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (2) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We expect we will remain an emerging growth company until December 31, 2018.




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ITEM 6.
Exhibits
Exhibit number
 
Description of document
2.1
 
3.1
 
3.2
 
3.3
 
4.1
 
4.2
 
4.3
 
10.1
 
10.2
 
31.1
 
31.2
 
32.1
 
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.
_____________________________________________________

(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.

(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) 
Filed herein.





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47


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: May 7, 2018
by:
/s/ Charles M. Baum
 
 
Chief Executive Officer
 
 
(Principal Executive Officer)
 
 
 
Date: May 7, 2018
by:
/s/ Jamie A. Donadio
 
 
Senior Vice President and Chief Financial Officer
 
 
(Principal Financial and Accounting Officer)
 
 
 
 
 
 


Exhibit
Exhibit 10.1
***Text Omitted and Filed Separately
with the Securities and Exchange Commission.
Confidential Treatment Requested
Under 17 C.F.R. Sections 200.80(b)(4) and Rule 24b-2
CONFIDENTIAL

COLLABORATION AND LICENSE AGREEMENT
THIS COLLABORATION AND LICENSE AGREEMENT (this “Agreement”) is entered into as of January 7, 2018 (the “Effective Date”) by and among Mirati Therapeutics, Inc., a Delaware corporation, having a place of business at 9393 Towne Centre Drive, Suite 200, San Diego, CA 92121 USA (“Mirati”), MethylGene Inc., a corporation organized under the laws of Canada and the wholly-owned subsidiary of Mirati, having a place of business at 9393 Towne Centre Drive, Suite 200, San Diego, CA 92121 USA (“MethylGene”), and BeiGene, Ltd., a corporation organized under the laws of the Cayman Islands having its principal address at Mourant Ozannes Corporate Services (Cayman) Limited, 94 Solaris Avenue, Camana Bay, Grand Cayman, Cayman Islands KY1-1108 (“BeiGene”). Mirati and BeiGene may be referred to herein individually as a “Party” and collectively as the “Parties.” Mirati and MethylGene may be referred to herein individually as a “Licensor” and collectively as the “Licensors.”
RECITALS
WHEREAS, the Licensors control certain intellectual property rights, data and know-how with respect to the clinical stage oncology product referred to as “sitravatinib”;
WHEREAS, BeiGene wishes to obtain from the Licensors the right to develop and commercialize the sitravatinib product in the Licensed Territory (as defined below), including the People’s Republic of China, both alone and in combination with other drugs and drug candidates, and is willing to commit to conduct development and regulatory activities to obtain approval of the sitravatinib product in such Licensed Territory, all as provided in and subject to the following terms; and
WHEREAS, the Licensors are willing to grant such rights to BeiGene, subject to BeiGene’s commitment to the collaborative development of the sitravatinib product, and to the other terms set forth below.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, BeiGene and the Licensors hereby agree as follows:
1.DEFINITIONS
1.1    AAA” has the meaning set forth in Section 15.2.
1.2    Accounting Standards” means U.S. GAAP or, to the extent that BeiGene adopts International Financial Reporting Standards (“IFRS”), then “Accounting Standards” means IFRS, in either case consistently applied.
    1.3     “Affiliate” means, with respect to a given Party, any 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, but for only so long as such control exists. As used in this Section 1.3, the term “control” (with correlative meanings for the terms “controlled by” and “under common control with”) means that the applicable entity has direct or indirect beneficial ownership of more than 50% of the voting share capital or other equity interest in the controlled Party, or the actual ability (directly or indirectly) to control the management and

 
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business policies of such Party. Notwithstanding the foregoing, for the purposes of this definition, in no event shall BeiGene be deemed an Affiliate of Mirati, and in no event shall Mirati be deemed an Affiliate of BeiGene.
1.4    Alliance Manager” has the meaning set forth in Section 3.7.
1.5    Applicable Laws” means all laws, statutes, rules, regulations, ordinances, and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city, or other political subdivision, agency, or other body, domestic or foreign, that are applicable to the particular situation, circumstances, rights or obligations.
1.6    Arbitrator” has the meaning set forth in Section 15.2.
1.7    BeiGene Data and Results” means all results, data, and analyses thereof, including non-clinical data and Clinical Data, generated by or on behalf of BeiGene or any of its Affiliates or Sublicensees during the Term with respect to the Compound or any Licensed Product pursuant to this Agreement, but for clarity excluding Manufacturing Data.
1.8    BeiGene Invention Patents” means any Patents that contain one or more claims that cover BeiGene Inventions.
1.9    BeiGene Inventions” means all Inventions, other than Compound-Specific Inventions, that (a) are conceived or reduced to practice by or on behalf of BeiGene or any of its Affiliates during the Term and (b) Controlled by BeiGene or any of its Affiliates. For clarity, BeiGene Inventions will include any Combination Product Inventions that are conceived or reduced to practice by or on behalf of BeiGene or its Affiliates during the Term that are Controlled by BeiGene or any of its Affiliates.
1.10    BeiGene Indemnitee” has the meaning set forth in Section 13.2.
1.11    BeiGene Know-How” means all Know-How, other than Compound-Specific Inventions and Manufacturing Data, that BeiGene or any of its Affiliates Controls during the Term that is necessary or reasonably useful to Develop, make, have made, use, sell, have sold, offer for sale, import, or otherwise Commercialize the Compound or any Licensed Product in the Field. For clarity, BeiGene Know-How shall include all BeiGene Inventions and BeiGene Data and Results.
1.12    BeiGene Patents” means all Patents, other than Licensed Patents, Joint Patents and Compound-Specific Invention Patents, that (a) BeiGene Controls during the Term and (b) claim the composition of matter, manufacture or use of the Compound or any Licensed Product in the Field, or otherwise are necessary or reasonably needed to the research, Development, manufacture, use, importation, offer for sale, sale, or other Commercialization of the Compound or any Licensed Product in the Field in any country or jurisdiction. For clarity, BeiGene Patents shall include any BeiGene Invention Patents.
1.13    Calendar Quarter means each respective period of three (3) consecutive months ending on March 31, June 30, September 30, and December 31.
1.14    Calendar Year” means each respective period of twelve (12) consecutive months ending on December 31.

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1.15    CFDA” means the China Food and Drug Administration, and any successor agency(ies) or authority thereto having substantially the same function.
1.16    Claim” has the meaning set forth in Section 13.1.
1.17    Clinical Data” means any and all data (together with all clinical trial reports and the results of analyses thereof, including case report forms) derived or generated in any Clinical Trial involving the Compound and/or any Licensed Product conducted by or on behalf of either Party.
1.18    Clinical Trial means, collectively, any Phase 1 Clinical Trial, Phase 2 Clinical Trial and/or Phase 3 Clinical Trial (including any Pivotal Clinical Trial).
1.19    CMC” has the meaning set forth in Section 1.1(a).
1.20    Combination Product” means a pharmaceutical product comprising the Compound in combination with at least one other active pharmaceutical ingredient, that is either co-formulated or separately formulated and packaged together, and/or sold together (including as a single unit), for a single price.
1.21    “Combination Product Inventions” means all Inventions, other than Compound-Specific Inventions, pertaining solely to a Combination Product.
1.22    “Combination Product Patents” means any Patents that contain one or more claims that cover Combination Product Inventions.
1.23    Commercial Supply Agreement” has the meaning set forth in Section 7.2.
1.24    Commercialization” or “Commercialize” means the conduct of all activities undertaken after Regulatory Approval relating to the promotion, sales, marketing, appropriate medical support, and distribution of Licensed Products in the Field in the Licensed Territory, including sales force efforts, detailing, advertising, promotional materials, market research, market access (including list price and reimbursement activities), and appropriate medical education and information services, publication, and scientific and medical affairs.
1.25    Commercialization Plan” has the meaning set forth in Section 6.2.
1.26    Commercially Reasonable Efforts” means, with respect to BeiGene’s performance of particular obligations hereunder with respect to the Compound or any Licensed Product, efforts that are consistent with the efforts applied and commonly used by companies in the pharmaceutical industry to conduct such tasks for a compound or product of similar strategic importance and market potential, and at a similar stage of development taking into account […***…].
1.27    Committee” means the JDC, JCC, or any subcommittee established by the JDC or JCC, as applicable.

3    *** Confidential Treatment Requested
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1.28    Compound” means the compound known as sitravatinib, having the chemical structure set forth in Exhibit 1.28, and any prodrugs, salts, solvates and metabolites of such compound.
1.29    Compound-Specific Inventions” means any Invention that relates solely and specifically to the composition of matter and/or manufacture of the Compound or a method of use of the Compound as a single agent.
1.30    Compound-Specific Patent” means any Patent that contains one or more claims that cover solely Compound-Specific Inventions.
1.31    Confidentiality Agreement” means the Confidential Disclosure Agreement between the Parties dated as of […***…].
1.32    Confidential Information means all information of a confidential or proprietary nature disclosed by or on behalf of a Party to the other Party under this Agreement, which may include any such information related to any scientific, clinical, engineering, manufacturing, marketing, financial, or personnel matters relating to a Party, or related to a Party’s present or future products, sales, suppliers, customers, employees, investors, business plans, Know-How, regulatory filings, data, compounds, research projects, work in progress, future developments or business, in all such cases whether disclosed in oral, written, graphic or electronic form, and whether or not specifically marked as confidential or proprietary, where under the circumstances in which such disclosure was made or given the nature of information disclosed, a reasonable person would consider such information confidential; provided, however, that in any event, the term “Confidential Information” of a Party (as disclosing Party) excludes any particular information that (a) is known by receiving Party (or its Affiliate) at the time of disclosure, and not through a prior disclosure by or on behalf of the disclosing Party, as documented by written records; (b) is or becomes properly in the public domain through no fault of the receiving Party; (c) is subsequently rightfully disclosed to the receiving Party by a Third Party who is not directly or indirectly under an obligation of confidentiality to the disclosing Party, as documented by written records; or (d) is developed by the receiving Party independently of, and without reference to or use of, Confidential Information received from or on behalf of the disclosing Party as documented by written records. The term “Confidential Information” of a party includes information disclosed as Confidential Information by or on behalf of either Party pursuant to the Confidentiality Agreement.
1.33    Control or “Controlled means, with respect to any Know-How, Patent, or other intellectual property right, that the applicable Party (or its Affiliate) owns or has a license (or sublicense) (but without taking into account any rights granted by one Party to the other Party under the terms of this Agreement) to or under such Know-How, Patent, or other intellectual property right and has the legal authority and right to grant access, a license, or a sublicense of or otherwise transfer or grant the right to the other Party as set forth under this Agreement under such Know-How, Patent, or other intellectual property rights, or to otherwise disclose proprietary or trade secret information to such other Party, without breaching the terms of any agreement with a Third Party, or misappropriating the proprietary or trade secret information of a Third Party.

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CONFIDENTIAL

1.34CTA” means: (a) a clinical trial application or any successor application or procedure required to initiate clinical testing of any Licensed Product in humans and (b) all supplements and amendments to any of the foregoing.

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1.35    Development or “Develop” means the conduct of all activities that are directed to obtaining or maintaining Regulatory Approval of a Licensed Product, obtaining Regulatory Approval for an additional indication for a Licensed Product that has previously obtained Regulatory Approval for an indication, or other lifecycle management of the Licensed Product in the applicable territory, including […***…].
1.36    Development Plan” means the plan setting forth the details of the Development work to be conducted by (or on behalf of) BeiGene on the Compound and any Licensed Product in the Licensed Territory, including […***…]. The initial agreed high level development plan (the “Initial Development Plan”) which will be used by the JDC to prepare the Development Plan is attached as Exhibit 1.36 of this Agreement.
1.37    Drug Substance” means the Compound in its tangible chemical form.
1.38    Excluded Claim” has the meaning set forth in Section 1.1(i).
1.39    Exploit” or “Exploitation” means to make, have made, import, export, use, have used, sell, have sold, offer for sale or otherwise exploit, including to Develop, Commercialize, register, modify, enhance, improve, manufacture, have manufactured, hold, or keep (whether for disposal or otherwise), or otherwise dispose of.
1.40    Field means use for the diagnosis, treatment, palliation or prevention of any indications, diseases or disorders in humans.
1.41    First Commercial Sale means the first sale or other commercial transfer by BeiGene or any of its Affiliates or Sublicensees to a Third Party of a Licensed Product in the Licensed Territory for end use after Regulatory Approval has been granted with respect to such Licensed Product in the Licensed Territory; provided, that, the following shall not constitute a First Commercial Sale: (a) any sale to an Affiliate or Sublicensee (unless the Affiliate or Sublicensee is the last entity in the distribution chain of any Licensed Product), (b) any use of a Licensed Product in Clinical Trials, pre-clinical studies or other research or Development activities, or (c) the disposal or transfer of any Licensed Product for a bona fide charitable purpose, without consideration, including for any compassionate use and/or as “named patient sales”.
1.42    cGCP” means the current good clinical practice as set out in ICH Harmonized Guidance on current Good Clinical Practice (CPMP/ICH/135/95) or U.S. 21 C.F.R. Chapters 50, 54, 56, 58, 210, 211 and 312, as may be amended from time to time.
1.43 cGLP” means the current good laboratory practice standards promulgated or endorsed by the FDA, as defined in U.S. 21 C.F.R. Part 58, as may be amended from time to time.

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1.44    cGMP” means the then-current good manufacturing practices required by the FDA and other Applicable Laws in the United States relating to the manufacture and testing of pharmaceutical materials, and comparable Applicable Laws and requirements of the CFDA relating to the manufacture and testing of pharmaceutical materials in the Licensed Territory, as may be amended from time to time, including applicable rules and guidelines promulgated under the International Conference on Harmonization.
1.45 Generic Product” means a drug product being sold commercially by a Third Party in a country in the Licensed Territory without authorization by BeiGene (or its Affiliate or Sublicensee), that (a) contains the same active ingredient as a Licensed Product, (b) is determined to be bioequivalent to such Licensed Product in accordance with Applicable Laws, or (c) is approved for sale in such country under an abbreviated route of regulatory approval in such country similar to the Abbreviated New Drug Application, or under 505(b)(2) of the United States Federal Food, Drug and Cosmetic Act, in the U.S. and is sold under a Regulatory Approval granted to the selling Third Party in such country which authorization is based substantially on clinical data pertaining to such Licensed Product. For purposes of clarity, for countries or jurisdictions in the Licensed Territory where no explicit generic regulations exist, the term Generic Product also shall mean any product being sold in such country by an unauthorized Third Party that contains the same active ingredient as a Licensed Product.
1.46    ICH” means the International Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use).
1.47    IND” means an investigational new drug application or equivalent application filed with the applicable Regulatory Authority in the Licensed Territory, which application is required to commence or conduct particular human clinical trial(s) in the Licensed Territory.
1.48    Indemnified Party” means a Mirati Indemnitee or BeiGene Indemnitee (as applicable) that seeks indemnification from the applicable Party pursuant to the terms of Article 13.4.
1.49    Indemnifying Party” has the meaning set forth in Section 13.4.
1.50    Initiation means, with respect to a clinical trial, the first dosing of the first human subject satisfying the enrollment criteria in such clinical trial.
1.51    Invention” means any Know-How (including for clarity any new and useful process, method of use, method of manufacture, chemical composition or composition of matter) which is made, conceived and/or reduced to practice by or on behalf of a Party or its Affiliates, or jointly by the Parties or their respective Affiliates in connection with the performance during the Term of this Agreement, including in connection with the conduct of the Development activities and/or the Exploitation of the Compound or any Licensed Product.
1.52    JCC” has the meaning set forth in Section 3.2.
1.53    JDC” has the meaning set forth in Section 3.1.
1.54    Joint Inventions” has the meaning set forth in Section 10.1(b)
1.55    Joint Patents” has the meaning set forth in Section 10.1(b).

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1.56    Know-How means all proprietary business, scientific or technical results, data and other information, in any tangible or intangible form whatsoever, including techniques, technology, trade secrets, inventions (whether patentable or not), know-how, trade secrets, methods, research data, clinical pharmacology data, chemistry-manufacture-controls data (including analytical and quality control data and stability data, Clinical Data and Manufacturing Data, pre-clinical data, and clinical data, regulatory documents, Regulatory Filings, compositions of matter, cells, cell lines, assays, animal models and other physical, biological, or chemical material, and all other scientific, clinical, regulatory, marketing, financial, and commercial information.
1.57    “Knowledge” or “Known to” means, with respect to a particular representation or other statement of Party set forth in this Agreement, […***…].
1.58    Licensed Know-How” means all Know-How that (a) either Licensor Controls during the Term, and (b) relates to the Compound or any Licensed Product, or any uses thereof, and is otherwise necessary or reasonably needed to research, Develop, manufacture, have manufactured, use, sell, offer for sale, import, export, Commercialize or otherwise Exploit the Compound and/or any Licensed Product in the Field in the Licensed Territory. For clarity, Licensed Know-How includes all Compound-Specific Inventions, but excludes all Know-How that does not relate to the Compound and relates to another proprietary compound of Mirati or its Affiliates.
1.59    Licensed Patents” means all Patents that (a) either Licensor Controls during the Term, and (b) claim the Compound, and/or the composition, manufacture, or use of the Compound or any Licensed Product in the Field in the Licensed Territory, or are otherwise necessary or reasonably needed for BeiGene to research, Develop, manufacture, have manufactured, use, sell, offer for sale, import, export, Commercialize or otherwise Exploit the Compound and/or any Licensed Products in the Field in the Licensed Territory, but excluding Mirati’s interest in any Joint Patents, and excluding all Patents to the extent of claims in such Patents that cover another proprietary compound of Mirati or its Affiliates and do not cover the Compound. For purposes of clarity, the Licensed Patents shall include as of the Effective Date the Patents set forth on Exhibit 1.59 attached hereto. Exhibit 1.59 shall be periodically updated during the Term to add any Licensed Patents described in this definition of which either Party becomes aware. For clarity, any Patent that is a Licensed Patent (that is, it meets the definition in this Section 1.59) shall be considered a Licensed Patent for purposes of this Agreement even if such Patent is not listed on Exhibit 1.59. For clarity, Licensed Patents includes all Compound-Specific Invention Patents.
1.60    Licensed Product” means any biological, pharmaceutical, therapeutic, diagnostic or prophylactic compound, substance, chemical composition or formulation that contains, incorporates or comprises the Compound, including any formulation or dosage form thereof.
1.61    Licensed Territory” means the countries listed on Exhibit 1.61 attached hereto.
1.62    Losses” has the meaning set forth in Section 13.1.

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1.63    Manufacturing Cost” means the actual cost to manufacture Drug Substance or Licensed Product, which means: (a) in the case of Drug Substance or Licensed Product (and related services) acquired from Third Parties, […***…]; and (b) in the case of manufacturing activities performed by Mirati or its Affiliates to manufacture Drug Substance or Licensed Product, […***…]: (i) […***…]; (ii) […***…]; and (iii) […***…].
1.64    Manufacturing Data” means all chemistry-manufacture-controls (“CMC”) data (including analytical data, test data, quality control data and stability data) and any other data relating directly to manufacture of the Compound or any Licensed Product that are generated by or on behalf of either Party, or jointly by the Parties, in connection with the performance of this Agreement, including the Development and/or Commercialization of the Compound and any Licensed Products.
1.65    “Marketing Authorization” means, with respect to a Licensed Product, the regulatory approval required by Applicable Laws to sell such Licensed Product for use in the Field in a country or region in the Licensed Territory including all required pricing and reimbursement approvals.
1.66    Mirati Inventions” means (a) any Inventions that are (i) conceived or reduced to practice by or on behalf of Mirati or its Affiliates during the Term and (ii) Controlled by Mirati or any of its Affiliates and (b) all Compound-Specific Inventions. For purposes of clarity, Mirati Inventions will include any Combination Product Inventions that are conceived or reduced to practice by or on behalf of Mirati or its Affiliate during the Term that are Controlled by Mirati or any of its Affiliates.
1.67    “Mirati Invention Patents” means any Patents that contain one or more claims that cover Mirati Inventions.
1.68    Mirati Indemnitee” has the meaning set forth in Section 13.1.
1.69    Net Sales means […***…]

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[…***…]:
(a)    […***…];
(b)    […***…];
(c)    […***…];
(d)    […***…];
(e)    […***…]; and
(f)    […***…].
[…***…].
[…***…]
[…***…].
[…***…].


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1.70    Ongoing Clinical Development Activities” means […***…].
1.71    Patents” means (a) all patents, certificates of invention, applications for certificates of invention, priority patent filings, and patent applications, and (b) any renewal, division, continuation (in whole or in part), or request for continued examination of any of such patents, certificates of invention, applications for certificates of invention and patent applications, and any all patents or certificates of invention issuing thereon, and any and all reissues, reexaminations, extensions, divisions, renewals, substitutions, confirmations, registrations, revalidations, revisions, and additions of or to any of the foregoing.
1.72Pivotal Clinical Trial” means a clinical trial (a) that a Regulatory Authority has confirmed can be considered as a registrational clinical trial for purposes of Regulatory Approval and (b) the completion of which potentially enables registration of the Licensed Product in a particular country in the Licensed Territory.
1.73    Public Official or Entity” means (a) any officer, employee (including physicians, hospital administrators, or other healthcare professionals), agent, representative, department, agency, de facto official, representative, corporate entity, instrumentality, or subdivision of any government, military, or international organization, including, but not limited to, any ministry or department of health or any state-owned or affiliated company or hospital, or (b) any candidate for political office, any political party, or any official of a political party.

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1.74    Regulatory Approval” means all approvals, licenses, registrations, and/or authorizations of each applicable country, federal, supranational, state, or local Regulatory Authority (including agency, department, bureau, or other government entity) that are necessary for the manufacture, use, storage, import, transport, and sale of Compound and/or Licensed Product (as applicable) in a given jurisdiction, including, with respect to a Licensed Product, the regulatory approval required by Applicable Laws to sell such Licensed Product for use in the Field in a country or region in the Licensed Territory.
1.75    Regulatory Authority” means any national, provincial, or local regulatory agency, department, bureau, or other government entity, that has responsibility in its applicable jurisdiction over the research, Development, manufacture, or Commercialization of the Compound or any Licensed Product in a given jurisdiction.
1.76    Regulatory Exclusivity” means any exclusivity (including for clarity new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data exclusivity) conferred by the Regulatory Authority in a particular country or jurisdiction in the Licensed Territory which confers an exclusive commercialization period during which BeiGene, its Affiliates or Sublicensees have the exclusive right to market and sell a Licensed Product in such country or jurisdiction, other than issued patent exclusivity.
1.77    Regulatory Filing” means, to the extent constituting Licensed Know-How or BeiGene Know-How, all applications, filings, submissions, approvals, licenses, registrations, permits, notifications, and authorizations (or waivers) with respect to the testing, Development, manufacture, or Commercialization of the Compound or any Licensed Product (as applicable) made to or received from any Regulatory Authority in a given country, including any INDs or CTAs.
1.78    Royalty Term” means, with respect to any Licensed Product sold in a country in the Licensed Territory, the period commencing with the First Commercial Sale of Licensed Product in such country and ending upon the latest to occur of: (i) the date of expiration of the last Valid Claim that covers such Licensed Product (including a method of use thereof that is the subject of a Regulatory Approval in such country and prevents the sale of a Generic Product in such country); (ii) the date that is ten (10) years after the date of such First Commercial Sale; and (iii) the expiration date of any Regulatory Exclusivity for such Licensed Product in such country.
1.79    Specifications” means all the attributes, acceptance criteria, and tests, analytical methods and/or limits, and the results thereof, as applicable, for which the raw materials, bulk active, intermediates, or process of making the Drug Substance must conform in order for the Drug Substance or Finished Licensed Product, as the case may be, to be acceptable for clinical use or commercial use, as applicable, as may be modified as set forth in this Agreement and the applicable Clinical Supply Agreement or Commercial Supply Agreement.
1.80    Sublicensee” means a Third Party to whom BeiGene (or any Affiliate of BeiGene) has granted a sublicense and consistent with Section 2.2.
1.81    “Sublicense Fees” means […***…]
[…***…].

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1.82    Term has the meaning set forth in Section 14.1.
1.83    Third Party means any entity other than Mirati, BeiGene, or an Affiliate of Mirati or BeiGene.
1.84    “Upstream Agreement” means the Intercompany License Agreement entered into between Mirati and MethylGene effective as of January 1, 2015.
1.85    […***…].
1.86    “Valid Claim” means a claim of an issued and unexpired patent within any of the Licensed Patents (other than any Patents that cover Compound-Specific Inventions that are conceived or reduced to practice by or on behalf of BeiGene or any of or its Affiliates or Sublicensees), which claim has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no further appeal can be taken, and which has not been disclaimed, denied, or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise.
2.    GRANT OF LICENSES
2.1    License Grants to BeiGene. Subject to the terms and conditions of this Agreement, each of the Licensors hereby grants to BeiGene during the Term an exclusive (even as to the Licensors, but subject to the Licensors’ retained rights as described in Section 2.3 below) royalty-bearing license, with the right to grant sublicenses as provided in Section 2.2, under the Licensed Know-How and Licensed Patents and the Licensors’ rights under any Joint Inventions and Joint Patents, to research, Develop, manufacture, have manufactured, offer for sale, sell, import, export and otherwise Commercialize the Compound and any Licensed Products in the Field in the Licensed Territory.
2.2    Sublicenses. BeiGene shall have the right to grant sublicenses under the rights granted under Section 2.1 through multiple tiers to (a) any Affiliates, (b) any Third Party engaged by it to conduct Development and/or Manufacturing activities, including contract research organizations, academic institutions, and regulatory affairs consultants, subject to the execution by each such Third Party of an agreement containing provisions with respect to confidentiality and assignment of Know-How that are consistent with, and comparable in scope to, Articles 10 and 11, and (c) any Third Party with respect to the Development, manufacture and/or Commercialization of any Licensed Products in the Field and in the Licensed Territory;

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provided, that BeiGene will include in each Sublicense Agreement the acknowledgement that such agreement is subject to the terms of this Agreement, and an obligation of each Sublicensee to comply with the relevant terms of this Agreement. For purposes of clarity, BeiGene shall have the right, in connection with the grant of a sublicense to any Third Party pursuant to this Section 2.2, to transfer to such Third Party such quantities of the Compound as are necessary for such Third Party to conduct Development, Manufacturing and/or Commercialization activities in accordance with the sublicense grants. Any and all such Sublicense Agreements shall be in writing and shall be subject to, and consistent with, the terms and conditions of this Agreement and shall include a provision that permits BeiGene to terminate the Sublicense Agreement if such Sublicensee (or an Affiliate of such Sublicensee) undertakes a Patent Challenge with respect to any Licensed Patents under which the Sublicensee is sublicensed or breaches the relevant terms of this Agreement. BeiGene shall provide Mirati with a copy of each such sublicense granted by BeiGene to an Affiliate or Sublicensee (redacted with respect to financial terms and sensitive commercial or technical information to the extent not necessary for Mirati to confirm BeiGene’s compliance with the terms of this Agreement) within […***…] days of executing such sublicense agreement.
2.3    Retained Rights. Each of the Licensors hereby expressly retains the right under the Licensed Know-How and Licensed Patents:
(a)    to exercise its rights, and perform its obligations, under this Agreement, whether directly or through one or more licensees or subcontractors, including the right to make and have made the Compound and any Licensed Product in the Licensed Territory solely for use or sale outside the Licensed Territory;
(b)    to practice and grant licenses under the Licensed Know-How and Licensed Patents outside of the scope of the licenses granted to BeiGene in Section 2.1; and
(c)    to […***…]; provided, that, (i) any exercise by a Licensor of its retained rights pursuant to this subsection (c) will require the prior approval of the JDC and (ii) BeiGene hereby agrees that Mirati will have the right to […***…].
2.4    License Grant to Mirati. BeiGene hereby grants to Mirati:
(a)    a non-exclusive, perpetual (except as otherwise provided in Section 14.4(b)), royalty-free and fully-paid (except as provided in Section 14.4(b)) license, with the rights to grant sublicenses through multiple tiers, under the BeiGene Inventions, BeiGene Invention Patents, BeiGene Know-How and BeiGene’s rights under any Joint Inventions and Joint Patents, to research, Develop, make, have made, use, sell, offer for sale, import, export and otherwise Commercialize the Compound and any Licensed Product in the Field outside the Licensed Territory; and
(b)    a non-exclusive, perpetual (except as otherwise provided in Section 14.4(b)), royalty-free and fully-paid (except as otherwise provided in Section 14.4(b)), license, with the right to sublicense through multiple tiers, under the BeiGene Inventions and BeiGene Invention Patents, and BeiGene Know-How to Develop, make and have made, and use the Compound and the Licensed Product in the Licensed Territory (i) solely for use outside of the Licensed Territory, (ii) solely to supply BeiGene in the conduct of Development activities in the Licensed Territory and (iii) subject to the JDC’s prior approval, to Develop the Compound

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and/or any Licensed Products in the Licensed Territory for the sole purpose of Developing and Commercializing Licensed Products outside the Licensed Territory.
2.5    No Implied Licenses; License Limitations.
(a)    No right or license under any Patents or other intellectual property rights of a Party is granted or shall be granted by implication to the other Party, and each Party agrees not to practice any Patents or other intellectual property rights of the other Party except pursuant to the licenses and other rights expressly granted in this Agreement or any other written agreement between the Parties. All such rights or licenses are or shall be granted only as expressly provided in the terms of this Agreement. Without limiting the foregoing, the Licensors hereby acknowledge and agree that no right or license is granted to the Licensors by BeiGene under this Agreement under any Patents or Know-How Controlled by BeiGene that covers or relates to any proprietary compound of BeiGene. Without limiting the foregoing, and notwithstanding any other provision of this Agreement, BeiGene hereby acknowledges and agrees that no right or license is granted to BeiGene by either of the Licensors under this Agreement under any Patents or Know-How owned or controlled by either of the Licensors that covers or relates to any proprietary compound of either of the Licensors other than the Compound.
(b)    BeiGene covenants that it, and its Affiliates and Sublicensees, will Develop, manufacture, and Commercialize the Licensed Products solely within the Licensed Territory for use in the Field, pursuant to and in accordance with the rights and licenses granted to it under and the terms and conditions of this Agreement, and will not use or practice Licensed Patents or Licensed Know-How except as expressly permitted in scope of the license granted to BeiGene in Section 2.1. BeiGene agrees and acknowledges that it has not been granted any rights (express or implied) to any Licensed Patents, Licensed Know-How, or Licensed Products under this Agreement outside of the Field or outside of the Licensed Territory, and accordingly agrees that during the Term it will not (i) Commercialize any Licensed Product outside of the Field or outside of the Licensed Territory or within the Licensed Territory for sale by or for BeiGene outside of the Field or outside of the Licensed Territory, or (ii) provide any Licensed Product to any Third Party, Sublicensee or Affiliate if BeiGene has actual knowledge or reasonably believes that such Third Party, Sublicensee or Affiliate, either directly or indirectly, is selling, or intends to sell such Licensed Product outside of the Field or outside of the Licensed Territory.
(c)    Mirati covenants that, except as otherwise expressly set forth or permitted in this Agreement (including under the retained rights in Section 2.3), Mirati, and its Affiliates and sublicensees, will Develop, manufacture, and Commercialize the Licensed Products solely outside the Licensed Territory. Mirati and its Affiliates and sublicensees will not use or practice any BeiGene Invention Patents or BeiGene Invention Know-How except as expressly permitted in this Agreement. Mirati agrees and acknowledges that except as otherwise expressly set forth or permitted in this Agreement, it has not been granted any rights (express or implied) to any BeiGene Invention Patents or BeiGene Inventions under this Agreement in the Licensed Territory, and accordingly agrees that during the Term it will not (i) Commercialize any Licensed Product in the Licensed Territory or outside the Licensed Territory intended for sale by or for Mirati inside of the Licensed Territory, or (ii) provide any Licensed Product to any Third Party, sublicensee or Affiliate if Mirati has actual knowledge or reasonably believes that such Third Party, sublicensee or Affiliate, either directly or indirectly, is selling, or intends to sell, such Licensed Product in the Licensed Territory.

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2.6    Technology Transfer.
(a)    After the Effective Date, and upon request of BeiGene, and pursuant to a separate Technology Transfer Plan to be mutually agreed in good faith by the Parties (the “Technology Transfer Plan”), Mirati will provide […***…] as described in this Agreement, including the supply of […***…] Drug Substance as provided in Section 7.1(a), and the transfer of Licensed Know-How in Mirati’s possession as of the Effective Date. In addition, Mirati shall provide BeiGene with […***…]. Each Party will be responsible for the costs and expenses incurred by such Party in connection with its conduct of the activities contemplated by the Technology Transfer Plan.
(b)    From time to time during the Term, Mirati shall transfer to BeiGene any additional Licensed Know-How generated by or on behalf of Mirati or its Affiliates with such reasonable frequency as the JDC or JCC may determine. From time to time during the Term, BeiGene shall transfer to Mirati any BeiGene Know-How generated by or on behalf of BeiGene or its Affiliates with such reasonable frequency as the JDC or JCC may determine.
(c)    The JDC and JCC shall each establish a mechanism for the reciprocal disclosure of applicable Know-How within its respective area of responsibility.
3.    GOVERNANCE
3.1    Joint Development Committee. […***…] after the Effective Date, the Parties will form a joint development and regulatory committee (the “JDC”) to coordinate the overall strategy, plans, and responsibilities of the Parties for Development of the Compound and any Licensed Products in the Licensed Territory and outside the Licensed Territory, to facilitate communication between the Parties and provide a forum for the Parties to review Development and regulatory matters pertaining to the Licensed Product in the Licensed Territory and outside the Licensed Territory, and to coordinate such Development activities in the Licensed Territory with Licensed Product development work outside the Licensed Territory. Except as otherwise provided herein, the role and responsibilities of the JDC are:
(a)    to oversee strategy, progress, and results with respect to Licensed Product Development in the Field […***…];
(b)    to review and approve the conduct by Mirati of any Development activities with respect to any Licensed Product in the Licensed Territory solely for use or sale outside the Licensed Territory, other than […***…];
(c)    to review and approve the Development Plan, with the understanding that the Initial Development Plan has been approved by the Parties, and any material amendments or revisions thereto;
(d)    to review and coordinate forecasting and supply of BeiGene’s expected requirements of Drug Substance and Drug Product for Development purposes;

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(e)    to review all material […***…];
(f)    to provide a forum for discussion of and coordinate interactions with Regulatory Authorities […***…];
(g)    to review any material Regulatory Filings with respect to the Licensed Product to be submitted to any Regulatory Authority […***…];
(h)    to review and discuss […***…];
(i)    to discuss and provide a forum for the exchange of pharmacovigilance and safety matters;
(j)    to provide a forum for discussion of and coordinate decisions related to […***…]; and
(k)    to discuss, review and approve any proposed publications and presentations by Mirati that includes the Clinical Data of BeiGene and to discuss and review any […***…], with the objective of protecting each Party’s Confidential Information and providing a reasonable opportunity for patent prosecution as appropriate prior to publication; and
(l)    to perform such other functions as the Parties may allocate to JDC in writing, where such functions are appropriate to further the purposes of this Agreement with respect to the Development of Licensed Products in the Licensed Territory.
3.2    Joint Commercialization Committee. At least […***…] prior to the first anticipated Regulatory Approval of any Licensed Product in the Licensed Territory, the Parties will form a joint commercialization committee (the “JCC”) to coordinate the overall strategy, plans, and responsibilities of the Parties, facilitate communication between the Parties and provide a forum for the Parties to review matters pertaining to Commercialization of Licensed Products in the Field in the Licensed Territory. Except as otherwise provided herein, the role and responsibilities of the JCC will be to:
(a)    discuss strategy, progress, and results with respect to Licensed Product Commercialization in the Field in the Licensed Territory, provided, that, for clarity, BeiGene shall retain sole decision-making authority with respect to Commercialization in the Licensed Territory;
(b)    review the Commercialization Plan and oversee implementation thereof;
(c)    solely to the extent that Mirati is supplying BeiGene with Drug Substance or Drug Product for Commercialization purposes, review and coordinate forecasting and supply of BeiGene’s expected requirements of Drug Substance and Drug Product for such Commercialization purposes;

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(d)    discuss and provide a forum for the exchange of pharmacovigilance and safety matters following commercial launch of Licensed Product;
(e)    review and discuss overall strategy and results with respect to Licensed Product Commercialization […***…]; and
(f)     perform such other functions as the Parties may deem appropriate to further the purposes of this Agreement with respect to the Commercialization of Licensed Product in the Licensed Territory.
3.3    Committee Composition. Each Committee will be composed of […***…] members appointed by Mirati and […***…] members appointed by BeiGene, each of which members shall be […***…]. Each Party will notify the other Party of its initial JDC member nominations within […***…] days after the Effective Date. The Parties, through the applicable Committee, may mutually agree to change the number of Committee members. Each Party may change its Committee members at any time by written notice to the other Party. Any member of a Committee may designate a substitute to attend and perform the functions of that member at any particular Committee meeting. Each Party may invite a reasonable number of non-member, non-voting representatives of such Party to attend any Committee meeting; provided that if either Party intends to have any Third Party (including any consultant) attend such a meeting, such Third Party shall be bound by confidentiality and non-use obligations consistent with the terms of this Agreement.
3.4    Meetings. Each Committee will hold meetings at such frequency as determined by the Committee members, but no less than […***…], unless otherwise reasonably agreed to by the Parties. The first JDC meeting shall be held within […***…] days after the Effective Date. The first JCC meeting shall be held within […***…] days after the JCC’s formation pursuant to Section 3.2. Such meetings may be conducted by videoconference, teleconference, or in person, as agreed to by the Parties, […***…]. Minutes will be kept of all Committee meetings. Meeting minutes will be prepared by BeiGene within […***…] days after the applicable meeting and sent to each member of the Committee for review and preliminary approval, which minutes shall be formally approved by the Committee at its next scheduled meeting. Any costs and expenses incurred related to a Committee meeting, including, if applicable, travel or telecommunication expenses, shall be borne separately by each Party.
3.5    Decision-Making. Decisions of a Committee with respect to matters within the responsibility of such Committee shall be made by unanimous vote, with Mirati’s Committee members collectively having one vote and BeiGene’s Committee members collectively having one vote. If a Committee cannot to reach unanimous agreement on such a matter before it for a period in excess of […***…] days, the matter shall be referred to […***…], who shall attempt in good faith to resolve such disagreement. If such disagreement has not been resolved within […***…] days after being referred to such executives, […***…]. Notwithstanding the foregoing, if any such disputed or unresolved matter involves

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[…***…], such disputed or unresolved matter must be resolved […***…].
3.6    Scope of Governance. Each Committee shall only have such powers, authority and responsibilities as are specifically assigned to it in this Agreement, and such powers shall be subject to the terms and conditions set forth herein. Without limiting the generality of the foregoing, no Committee will have any power to amend this Agreement, and no Committee decision shall be in contravention of or conflict with any terms and conditions of this Agreement. It is understood and agreed that issues to be formally decided by a Committee are only those specific issues that are expressly provided in this Agreement to be decided by such Committee.
3.7    Alliance Managers. Promptly after the Effective Date, each Party shall appoint an individual who shall be an employee of such Party having appropriate qualification and experience to act as the alliance manager for such Party with respect to the matters covered by this Agreement (the “Alliance Manager”). Each Alliance Manager shall be responsible for coordinating and managing processes and interfacing between the Parties on a day-to-day basis throughout the Term. The Alliance Manager will ensure communication to the applicable Committees of all relevant matters raised at any joint subcommittees or working groups. Each Alliance Manager shall be permitted to attend meetings of the applicable Committees as non-voting participants. The Alliance Managers shall be the primary contact for the Parties regarding the day-to-day activities contemplated by this Agreement and shall facilitate information exchange and discussion of all such activities hereunder, and the results thereof. Each Party may replace its Alliance Manager with an alternative representative at any time with prior written notice to the other Party. Any Alliance Manager may designate a substitute to temporarily perform the functions of that Alliance Manager. Each Alliance Manager shall be charged with creating and maintaining a collaborative work environment within each Committee and its subcommittees, if any. Costs with respect to Alliance Managers shall be borne separately by each Party.
3.8    Discontinuation of Participation on a Committee. For clarity, Mirati’s membership in any particular Committee shall be at its sole discretion, as a matter of right and not obligation, for the sole purpose of participation in governance, decision-making, and information exchange with respect to activities within the jurisdiction of the Committee. Mirati shall have the right to withdraw, at any time, from membership on a Committee upon […***…] days’ prior written notice to BeiGene, which notice shall be effective upon the expiration of such […***…] day period. Following the issuance of such notice: (a) Mirati’s membership in such Committee shall be terminated, (b) Mirati’s Committee members shall no longer have any decision-making rights as provided in Section 3.5 and (c) each Party shall have the obligation to provide and the right to continue to receive the information it would otherwise be required to provide and entitled to receive under the Agreement and to participate directly with the other Party in discussions, reviews and approvals currently allocated to such Committee pursuant to this Article 3.
4.    DEVELOPMENT
4.1    Overview of Development. The Parties acknowledge and agree that the Development of Licensed Product in the Licensed Territory shall be coordinated and consistent with the worldwide (outside of the Licensed Territory) Development of Licensed Product.

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4.2    Development Activities. Subject to the terms and conditions of this Agreement, BeiGene shall conduct Development of the Compound and any Licensed Product in accordance with, and as set forth in, the Development Plan. BeiGene will be solely responsible for obtaining all Regulatory Approvals in each country in the Licensed Territory at its sole expense. BeiGene will have the right to engage capable, reputable and experienced contract research organizations to conduct particular Development activities as are appropriate to be conducted by subcontractors. BeiGene shall keep the JDC informed of the progress and results of such Development activities as provided below.
4.3    Performance.
(a)    BeiGene shall use Commercially Reasonable Efforts to Develop the Licensed Product and seek and maintain Regulatory Approvals for the Licensed Product in the Field in the Licensed Territory.
(b)    BeiGene shall perform its Development obligations in compliance with all Applicable Laws, including the regulations promulgated by the relevant Regulatory Authorities for the Development, manufacture, testing, and Commercialization of pharmaceutical products in the Licensed Territory, in good scientific manner, and in compliance in all material respects with all applicable national and international guidelines (e.g., ICH, cGCP, cGMP).
4.4    Development Plan; Diligence. The Development of the Compound and any Licensed Products under this Agreement shall be conducted pursuant to the Development Plan. Without limiting the foregoing but subject to Section 4.5, BeiGene will use Commercially Reasonable Efforts to […***…]. From time to time, BeiGene may submit to the JDC for discussion any proposed modifications or amendments to the then-current Development Plan, and the JDC shall discuss such proposed modifications, pursuant to Section 3.1(c), at its next meeting. From time to time, Mirati may notify BeiGene of any proposed modifications to Mirati’s Development activities or strategy via the JDC, and the JDC shall discuss such proposed modifications, pursuant to Section 3.1(c), at its next meeting.
4.5    Obligations of Mirati. Notwithstanding the foregoing, the Parties hereby acknowledge and agree that (a) the ability of BeiGene to satisfy its diligence obligations in this Article 4 and achieve the clinical milestone events set forth in Section 4.4 are dependent upon (i) certain Development activities to be conducted by Mirati, including […***…], (ii) to the extent required by the Regulatory Authority, […***…] and (iii) the […***…] in accordance with the Initial Development Plan and (b) to the extent that Mirati fails to comply with such activities on a timely basis, the Parties shall discuss and agree in good faith on an appropriate modification to BeiGene’s diligence obligations set forth in this Article 4 to account for such failure.
4.6    Records. Each Party shall maintain full and complete records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall

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fully and properly reflect all work done and all data and other results achieved or obtained by or on behalf of such Party in the performance of Development activities with respect to the Compound or any Licensed Product under the Development Plan and as contemplated by this Agreement.
4.7    Disclosures Regarding Development Efforts. The Parties will share information about their respective Development activities in the Field through the JDC as follows:
(a)    BeiGene. BeiGene shall (i) provide to the JDC, not less than […***…] every Calendar Year during the Term, a report (each, a “Development Report”) that summarizes (A) […***…] and (B) any Compound-Specific Inventions that are first conceived or reduced to practice by BeiGene by over such […***…] period and (ii) upon the written request of Mirati, meet in person or by teleconference […***…] with respect to […***…].
(b)    Mirati. Mirati shall (i) provide to the JDC, not less than […***…] every Calendar Year during the Term, a report that summarizes (A) […***…] and (B) any Inventions that are first conceived or reduced to practice by Mirati over such […***…] period and (ii) upon the written request of Mirati, meet in person or by teleconference at least […***…] with respect to […***…].

4.8    Access and Use of Data. Each Party shall promptly provide the other Party with access to […***…]. Subject to the licenses and other rights granted under this Agreement (a) Mirati shall have a right of access, a right of reference and a right to use and incorporate all results, data, and analyses thereof, […***…], and (b) BeiGene shall have a right of access, a right of reference and a right to use and incorporate all results, data, and analyses thereof, including […***…].

4.9    Coordination. Notwithstanding anything to the contrary in this Agreement, subject to Applicable Laws, Mirati will discuss in good faith and coordinate with BeiGene, through the JSC, with respect to Mirati’s (and its Affiliates’ and sublicensees’) Development activities (including the conduct of any Clinical Trials) and Manufacturing activities, in each case with respect to the Compound and any Licensed Products […***…]. Mirati will consider in good faith and reasonably address BeiGene’s input and comments with respect thereto. Without limiting the

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foregoing, in the event that BeiGene determines, in its reasonable discretion, that a given Development activity (including any Clinical Trial) or Manufacturing activity for any Compound or any Licensed Product outside the Licensed Territory is reasonably likely to pose a material adverse safety issue for the Development, manufacture or Commercialization of the Compound or any Licensed Product in the Licensed Territory, BeiGene will have the right to notify Mirati thereof in writing and Mirati will reasonably consult with BeiGene in good faith in connection therewith prior to conducting the applicable Development activity (including any Clinical Trial) or Manufacturing activity.
5.    REGULATORY ACTIVITIES
5.1    General. Subject to, and in accordance with, the terms and conditions of this Agreement and the requirements of all Applicable Laws, BeiGene, at its own expense, shall use Commercially Reasonable Efforts to prepare and file all Regulatory Filings with respect to the Licensed Product required to Develop and, if successful, to obtain and maintain Regulatory Approvals of the Licensed Product in the Field in the Licensed Territory. Mirati will provide reasonable regulatory and administrative support and assistance to BeiGene, to be coordinated by the JDC, in connection with the conduct by BeiGene of its activities under this Section 5.1 including the submission by BeiGene of any Regulatory Filings in the Licensed Territory and, with respect to the submission by BeiGene of an IND or CTA for any Licensed Product in China, (i) the provision of a notarized authorization letter and business license and (ii) the provision of a notarized copy of the GLP certificate of Mirati’s contract research organization responsible for the performance of preclinical activities on the Compound. Without limiting the remainder of this Article 5, BeiGene, through the JDC, shall […***…].
5.2    Regulatory Expenses. BeiGene shall be responsible for all costs and expenses of preparing, maintaining, formatting, and filing Regulatory Filings for Licensed Products in the Licensed Territory and for maintaining Regulatory Approval for Licensed Products in the Licensed Territory.
5.3    Regulatory Filings.
(a)    Review. The Alliance Managers shall coordinate communication and the exchange of information between the Parties with respect to Regulatory Filings to be prepared and submitted by or for BeiGene in the Licensed Territory.
(b)    Copies.
(i)    Subject to Applicable Laws, BeiGene promptly shall provide to Mirati: (A) electronic copies (both as filed and also in English) of each Regulatory Filing as submitted to Regulatory Authorities in the Licensed Territory, (B) copies (both as filed or received, and also in English) of all correspondence with respect to Regulatory Filings to and from any Regulatory Authority in the Licensed Territory, and (C) a brief statement of any material changes in the final Regulatory Filings from the summaries previously provided by BeiGene to Mirati pursuant to subsection (A) above. Without limiting the generality of the foregoing, BeiGene shall […***…]

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[…***…]. The Parties will discuss in good faith whether any of the documents to be provided by BeiGene to Mirati under this Section 5.3(b) should be translated into English and the allocation of responsibility for paying the costs of any such translations between the Parties.
(ii)    Subject to Applicable Laws, Mirati shall provide BeiGene with copies of all material correspondence with respect to the Compound or any Licensed Product to and from any Regulatory Authority pertaining to Regulatory Filings outside of the Licensed Territory promptly so as to permit BeiGene to comply with its obligations under Applicable Laws in the Licensed Territory.
(c)    BeiGene shall own all such Regulatory Filings covering, and all Regulatory Approvals of, Licensed Product in the Licensed Territory, subject to subsection (d) below and to the provisions of Article 14.
(d)    Rights of Reference. Each Party hereby grants to the other Party a transferable right of reference to any and all Regulatory Filings, with any Regulatory Authority, and including any Regulatory Approvals, in the Licensed Territory (with respect to BeiGene) and outside the Licensed Territory (with respect to Mirati) for use in connection with, or as reasonably needed for, the Development and/or manufacturing of the Compound or Licensed Product inside the Licensed Territory, and for the Development and/or Commercialization of the Compound or Licensed Product outside the Licensed Territory.
5.4    Regulatory Meetings. Through the JDC, BeiGene shall provide Mirati with a schedule of any material in-person meeting or material teleconference with the Regulatory Authorities (or related advisory committees) in the Licensed Territory planned for the next […***…] that relates to the Development of the Licensed Products in the Licensed Territory (each, a “Regulatory Meeting”). BeiGene shall be solely responsible for any communications with Regulatory Authorities occurring or required in connection with performing its regulatory responsibilities set forth in this Article 5 with respect to the Licensed Product in the Licensed Territory, and Mirati shall have the right to provide input in preparation for each such Regulatory Meeting and the right at its sole expense and upon reasonable advance written notice, but not the obligation, to have its representatives attend and participate in each such material Regulatory Meeting.
5.5    Safety; Adverse Event Reporting.
(a)    Database. Mirati shall establish, hold, and maintain a global drug safety management system and database for the Licensed Products. As between the Parties, Mirati shall enter into such database all pharmacovigilance and other drug safety data for the Licensed Products (including Adverse Events) used outside the Licensed Territory as required by Applicable Laws (including any such data collected by its Third Party Licensees). Each Party shall have the right to access from such global drug safety database all drug safety data necessary for such Party to comply with all Applicable Laws in such Party’s territory. BeiGene shall provide to Mirati, for incorporation into such database, all safety-related information generated or obtained from use of Licensed Product in the Licensed Territory.
(b)    BeiGene Obligations. BeiGene shall be responsible, at its expense, for: (i) collecting all pharmacovigilance and other drug safety data for the Licensed Products in the

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Licensed Territory as required by Applicable Laws; (ii) reporting all such safety data, including adverse events in the Licensed Territory, to the applicable Regulatory Authorities in the Licensed Territory as appropriate to be in compliance with all Applicable Laws; (iii) timely reporting all such safety data to Mirati in the format for entry into the global safety database as specified by Mirati; and (iv) providing a copy of all material correspondence with any data and safety management board. The JDC may establish a safety subcommittee, and if so, all pharmacovigilance and other drug safety data for the Licensed Products in the Licensed Territory, including adverse event reports, shall then be submitted to such safety subcommittee concurrently with the reporting of such data to Mirati pursuant to subsection (iii) above. The Parties will discuss in good faith whether any of the documents to be provided by BeiGene under this Section 5.5(b) should be translated into English and the allocation of responsibility for paying the costs of any such translations between the Parties.
(c)    Sharing of Safety Data. BeiGene expressly acknowledges that Mirati shall have the right to provide all information received by Mirati pursuant to this Section 5.5 to appropriate Regulatory Authorities outside the Licensed Territory, and any of its applicable Affiliates and other licensees engaged in Development and Commercialization activities of the Licensed Product. Mirati expressly acknowledges that BeiGene shall have the right to provide all information received from Mirati by BeiGene from the Mirati safety database to appropriate Regulatory Authorities within the Licensed Territory, and any of its applicable Affiliates and other Sublicensees engaged in Development and Commercialization activities of the Licensed Product in the Licensed Territory.
(d)    Pharmacovigilance Agreement. As soon as practicable after the Effective Date, the JDC will develop a mutually acceptable pharmacovigilance and safety agreement (to be agreed upon and executed by the Parties) setting forth the Parties’ respective obligations in detail regarding pharmacovigilance and the exchange and reporting of drug safety data.
5.6    […***…].
5.7    Governmental Inspections and Inquiries. BeiGene shall advise Mirati promptly after BeiGene’s receipt of notice thereof, of (i) any planned Regulatory Authority visit to the portion of the facilities of BeiGene and/or the facilities of Mirati or their respective Affiliates where the Compound or any Licensed Product is manufactured, stored or handled, or (ii) any material written inquiries by a Regulatory Authority concerning such facilities, BeiGene’s or its Affiliates’ procedures with respect to the manufacture, storage or handling of the Compound or any Licensed Product. If a Regulatory Authority makes an unannounced or unplanned visit, BeiGene shall inform Mirati of the visit as soon as reasonably practicable after BeiGene obtains actual knowledge of the visit. BeiGene shall inform Mirati, as soon as practicable, regarding the purpose and result of such visit or inquiry, and will provide to Mirati copies of any minutes or other records of the inspection generated by BeiGene promptly following such inspection, and any report, response or correspondence provided by BeiGene or its Affiliate, as the case may be, to such Regulatory Authority or issued by or provided by

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such Regulatory Authority to BeiGene or its Affiliate, as the case may be, in connection with such visit or inquiry. The Parties will discuss in good faith whether any of the documents to be provided by BeiGene under this Section 5.7 should be translated into English and the allocation of responsibility for paying the costs of any such translations between the Parties.
6.    COMMERCIALIZATION
6.1    Responsibilities and Diligence. BeiGene shall be responsible, at its expense, for Commercializing the Licensed Product in the Field in the Licensed Territory, in compliance and accordance with the terms and conditions of this Agreement. BeiGene shall use Commercially Reasonable Efforts to (a) Commercialize the Licensed Product(s) in the countries within Licensed Territory, and (b) achieve the First Commercial Sale in the applicable country in the Licensed Territory […***…] after obtaining Regulatory Approval for such Licensed Product in such country in accordance with the Development Plan. In conducting Commercialization of Licensed Product, BeiGene will comply, and will ensure that its Affiliates comply, and will include in each of its Sublicense Agreements an obligation of its Sublicensees to comply, in all material respects with all Applicable Laws related to its Development, manufacturing, and Commercialization of the Licensed Products, including, as applicable, cGCP, cGLP, and cGMP, and all applicable anti-bribery and anti-corruption laws and regulations. Without limiting the generality of the foregoing, BeiGene will not promote or market or sell any of the Licensed Products in a manner that would conflict with Applicable Laws.
6.2    Commercialization Plan. BeiGene shall prepare and submit to the JCC for its review a plan […***…] (the “Commercialization Plan”). BeiGene shall submit a proposed draft of the Commercialization Plan for the Licensed Territory to the JCC no later than […***…] prior to the anticipated date of Regulatory Approval of the Licensed Product in the Licensed Territory. BeiGene shall deliver to the JCC an update of the relevant sections of the Commercialization Plan on […***…] during the Term. Updates to the Commercialization Plan will reflect, among other things, […***…].
6.3    Reports. BeiGene shall update the JCC at the JCC’s regularly-scheduled meetings regarding BeiGene’s Commercialization activities for the Licensed Products in the Licensed Territory and the progress and results thereof. In addition, BeiGene shall present written summary reports […***…] to the JCC setting forth BeiGene’s significant Commercialization activities with respect to Licensed Products (including results thereof) in the Licensed Territory pursuant to this Agreement and including a non-binding forecast for the Net Sales of the Licensed Product in the Licensed Territory in the next […***…].
6.4    Patent Rights Marking. To the extent required by Applicable Law and customary in the industry for such products, BeiGene will mark all Licensed Products sold in the Licensed Territory by BeiGene, its Affiliates, or Third Party Licensees with appropriate Licensed Product trademarks and patent numbers.
7.    MANUFACTURE AND SUPPLY

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7.1    Supply of Drug Substance and Drug Product.
(a)    Clinical Supply. Initially, Mirati will have the sole right and responsibility for the manufacture and supply to BeiGene of Drug Substance and Drug Product for use by BeiGene to conduct Development activities in the Licensed Territory, including the initial supply of Drug Product as reasonably required by BeiGene to conduct initial Development activities under the Initial Development Plan. Within […***…] of the Effective Date, the Parties will negotiate in good faith and execute a clinical manufacturing and supply agreement pursuant to which BeiGene may purchase from Mirati amounts of Drug Substance and/or Drug Product for use by BeiGene to conduct the Development activities in the Licensed Territory (“Clinical Supply Agreement”). Except for the clinical supply of Drug Substance and/or Drug Product by Mirati as provided in this Section 7.1, BeiGene shall be responsible for manufacturing and supplying, itself or through one or more Third Party contract manufacturers, BeiGene’s requirements for Drug Substance and Drug Product for use in BeiGene’s Development of the Compound or any Licensed Products in the Licensed Territory.
(b)    Ordering and Forecasts, Price. Mirati will supply quantities of Drug Substance and/or Drug Product as reasonably required by BeiGene to Develop the Licensed Product in the Licensed Territory in accordance with the Development Plan, and as specified in the Clinical Supply Agreement. During the period commencing on the Effective Date and continuing until […***…] the cost of supply of the Compound for use by BeiGene to conduct Development Activities in the Licensed Territory, and thereafter […***…]. The JDC shall coordinate the forecast of quantity and schedule for clinical supply of Drug Substance and Drug Product under this Section 7.1, which shall be consistent with the Development Plan; provided, however, that until particular forecast(s) are approved by JDC in accordance with this Section 7.1, any forecast provided by BeiGene shall be non-binding and operative only for planning purposes, and neither Party shall have any contractual obligation with respect thereto. The Parties may approve any such clinical Drug Substance and/or Drug Product forecast by mutual agreement evidenced by:
(i)    a request for quote submitted by BeiGene to Mirati (or its authorized contract manufacturer(s)) specifically defining its requirements for Drug Substance and/or Drug Product, including at least a specific quantity, and a required schedule for delivery thereof, which quote is accepted by Mirati in writing;
(ii)    a quote from Mirati (or its authorized contract manufacturer(s)) to BeiGene for supply of Drug Substance and/or Drug Product setting forth a defined quantity, delivery schedule, and estimated price […***…], which quote is accepted by BeiGene in writing;
(iii)    a purchase order issued by BeiGene to Mirati (or its authorized contract manufacturer(s)) consistent with the mutually agreed terms stated in such quote, and accepted by Mirati in writing. Title to the Drug Substance and/or Drug Product, as applicable, shall pass […***…]; or
(iv)    otherwise as set forth in, or as determined in accordance with, the Clinical Supply Agreement.

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Mirati (or its authorized contract manufacturer(s)) shall invoice BeiGene following delivery of Drug Substance and/or Drug Product to BeiGene. BeiGene shall pay invoices for Drug Substance and/or Drug Product ordered within […***…] days of its receipt of such invoices, subject to BeiGene’s right of replacement of defective Drug Substance and/or Drug Product as set forth in Section 7.1(c); it being further understood that to the extent BeiGene’s inspection of the delivered Drug Substance and/or Drug Product reveals that such Drug Substance and/or Drug Product failed to conform to any warranty provided to Section 7.1(c), such amounts paid for such Drug Substance and/or Drug Product or Licensed Product […***…].
(c)    Non-Commercial Drug Substance and Drug Product Representation and Warranty. The Drug Substance and Drug Product supplied by Mirati pursuant to Section 7.1(a) shall, as of delivery by Mirati to the carrier: (i) be manufactured in accordance with cGMP; and (ii) meet the Specifications. Within […***…] days following receipt of each delivery under Section 7.1(a), BeiGene shall conduct an inspection of the Drug Substance and/or Drug Product and notify Mirati if any such Drug Substance and/or Drug Product has failed to conform to the warranty provided above in this Section 7.1(c). In the event that […***…], Mirati shall either (A) […***…]; or (B) […***…].
(d)    Quality Agreement. […***…] after the Effective Date, the JDC will develop a mutually acceptable quality agreement (to be agreed upon and executed by the Parties) setting forth the Parties’ respective obligations in detail regarding the manufacture, packaging, testing, storage, and release of clinical and/or commercial Drug Substance and Drug Product to assure such Drug Substance and Drug Product is manufactured according to agreed Specifications and complies with Applicable Laws.
(e)     Manufacturing Technology Transfer. Notwithstanding anything to the contrary in this Agreement, in order to facilitate BeiGene’s exercise of its license to manufacture Licensed Products in accordance with Section 2.1, Mirati shall, as promptly as possible following its receipt of any written request by BeiGene (each, a “Manufacturing Technology Transfer Request”) (i) disclose and/or transfer to BeiGene such Know-How as may be reasonably necessary or useful for BeiGene to manufacture or have any Third Party contract manufacturing organization (“CMO”) engaged by BeiGene to manufacture Licensed Products, to the extent Controlled by Mirati as of such date and (ii) otherwise provide reasonable assistance to enable BeiGene or such CMO to manufacture or have manufactured such Licensed Product (“Manufacturing Technology Transfer”). Such Manufacturing Technology Transfer will be made to BeiGene or any CMO engaged by BeiGene and reasonably acceptable to Mirati pursuant to a plan and budget (the “Manufacturing Technology Transfer Plan”) to be prepared by Mirati and provided to BeiGene for its review and approval as soon as practicable and no later than […***…] days following Mirati’s receipt of the Manufacturing Technology Transfer Request from BeiGene. Each Party will pay […***…] of the costs and expenses of such Manufacturing Technology Transfer as set forth in the Manufacturing Technology Transfer Plan. Upon completion of such Manufacturing Technology Transfer, BeiGene will have the sole right and responsibility, at its sole cost and

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expense, for manufacturing Licensed Products for Development and Commercialization in the Licensed Territory.
7.2    Commercial Supply of Drug Substance and Drug Product. Except as otherwise set forth in this Section 7.2, BeiGene shall be responsible to manufacture and supply, itself or through one or more Third Party contract manufacturers, BeiGene’s requirements for Drug Substance and/or Drug Product for use in BeiGene’s Commercialization of Licensed Products under this Agreement. Such manufacture shall be conducted in all cases in compliance with all Applicable Laws and sufficient to meet all market demand for Licensed Products in the Licensed Territory. […***…] (herein, the “Mirati Commercial Supply Agreement”). […***…] (the “BeiGene Commercial Supply Agreement.”). Such Mirati Commercial Supply Agreement or, to the extent negotiated and executed, the BeiGene Commercial Supply Agreement, as applicable, shall contain commercially reasonable, industry standard terms for similar commercial supply agreements, […***…]. Following the execution of such either Commercial Supply Agreement (and as contemplated by the applicable Commercial Supply Agreement), the Parties and the relevant Third Party contract manufacturer, if applicable, shall negotiate in good faith to enter into a quality agreement governing the Specifications and other technical aspects of such commercial supply of the Drug Substance and/or Drug Product.
7.3    […***…].
8.    FINANCIAL TERMS
8.1    Upfront License Fee. Within […***…] Business Days of the Effective Date, BeiGene shall pay to Mirati, in cash, ten million USD ($10,000,000.00), such payment being non-refundable and non-creditable.
8.2    Milestone Payments.
(a)    Clinical Development Milestones. BeiGene shall pay to Mirati the following non-refundable, non-creditable milestone payments set forth in the table below.

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Milestone Event
Milestone Payment (USD)
  […***…]
US $[…***…]
 […***…]
US $[…***…]

(b)    Regulatory Milestones. BeiGene shall pay to Mirati the following non-refundable, non-creditable milestone payments set forth in the table below, with respect to each Licensed Product.
Milestone Event
Milestone Payment (USD)
[…***…]
$[…***…]
[…***…]
$[…***…]

(c)    Sales-Based Milestones. BeiGene shall pay to Mirati the following non-refundable, non-creditable milestone payments set forth in the table below:

Sales Milestone Event
Milestone Payment (USD)
[…***…]
$[…***…]
[…***…]
$[…***…]
[…***…]
$[…***…]
[…***…]
$[…***…]

(d)    For clarity, (i) each milestone payment set forth herein shall be payable only once, regardless of the number of times the corresponding milestone event is achieved and (ii) any Sublicense Fees received by BeiGene with respect to a Licensed Product […***…]

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[…***…] for purposes of determining whether a Sales Milestone Event has been achieved under Section 8.2(c).
8.3    Royalty Payments.
(a)    Royalty Rate. During the applicable Royalty Term, BeiGene shall pay to Mirati non-refundable, non-creditable royalties as a percentage of the Net Sales of all Licensed Products in the Licensed Territory, as calculated by multiplying the applicable royalty rate (as set forth in the following royalty rate schedule) by the amount of Net Sales of all Licensed Products in the Licensed Territory in the applicable Calendar Year (on a by “tier” basis):
Amount of Net Sales in the Calendar Year
Royalty Rate Applicable to Net Sales Tier
$[…***…] through $[…***…]
[…***…]%
Above $[…***…] and through $[…***…]
[…***…]%
Above $[…***…] and through $[…***…]
[…***…]%
Above $[…***…] and through $[…***…]
[…***…]%
Above $[…***…] and through $[…***…]
[…***…]%
Above $[…***…]
20%

(b)    Terms of Royalty Obligations. Royalties shall be payable hereunder on sales of Licensed Products in a country in the Licensed Territory throughout the Royalty Term applicable to the Licensed Products in such country.
(c)    Generic Sales. If any Third Party sells a Generic Product in a country in the Licensed Territory in which Licensed Product is then being sold by BeiGene, the royalties payable by BeiGene for sales of Licensed Products in such country (during the period when such Generic Product is being sold) will be reduced by […***…] percent ([…***…]%) of the amount otherwise owed under this Section 8.3 for such sales.
(d)    Anti-Stacking. If BeiGene is required to take a license under Patents of a Third Party issued in a country in the Licensed Territory that claim the Compound or its use, in order to sell Licensed Product in such country, then BeiGene shall be entitled to credit, against royalties owed by BeiGene to Mirati on Net Sales of such Licensed Product in such country under this Agreement, […***…] percent ([…***…]%) of any payments, including upfront payments, milestone payments and royalty payments paid in the applicable […***…] to such Third Party by BeiGene that are in consideration for the grant of such license with respect to the Licensed Product in such country, […***…]
[…***…].

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9.    PAYMENT; RECORDS; AUDITS
9.1    Payment; Reports. The royalty payments due under Section 8.3 shall be calculated and reported on a Calendar Quarter basis. All royalty payments due under Section 8.3 shall be paid within […***…] days after the end of each Calendar Quarter. Within […***…] days after the end of each Calendar Quarter, BeiGene shall provide to Mirati a complete and accurate report setting forth the gross sales and the calculation of Net Sales of Licensed Products by BeiGene and its Affiliates and Sublicensees in the Licensed Territory during such Calendar Quarter, in sufficient detail to permit confirmation of the accuracy of the royalty payment made, including any reductions taken in the calculation of Net Sales pursuant to Section 1.69 and the exchange rates used. BeiGene shall provide Mirati promptly written notice of the achievement of a milestone event in Section 8.2, and shall pay to Mirati in cash the milestone payment owed for such achievement, within […***…] days of such achievement.
9.2    Exchange Rate; Manner and Place of Payment. All references to dollars and “$” herein shall refer to U.S. dollars. All payments hereunder shall be payable in U.S. dollars. When conversion of payments or amounts received is required for the calculation of Net Sales from any currency other than U.S. dollars, such conversion shall be made by using the exchange rates […***…], for the applicable currency exchange, unless otherwise agreed in writing by the Parties. All payments owed under this Agreement shall be made by wire transfer in immediately available funds to a bank and account designated in writing by the receiving Party, unless otherwise specified in writing by such Party.
9.3    Tax Withholding. Mirati will pay any and all taxes levied on it on account of any payments made to it under this Agreement. If any taxes (other than “value added” taxes) are legally required to be withheld by BeiGene from any payment made to Mirati under this Agreement, BeiGene will (a) deduct such taxes from the payment made to Mirati, (b) timely pay the taxes to the proper taxing authority, and (c) send proof of payment to Mirati and certify its receipt by the taxing authority within […***…] days following such payment. The Parties will cooperate reasonably and in good faith to obtain the benefit of any relevant tax treaties and otherwise to minimize as far as reasonably possible any withholding or other taxes that may be levied on any payments due to Mirati hereunder.
9.4    Restrictions on Fund Transfers. In the event that, by reason of applicable laws in the Licensed Territory, it becomes impossible or illegal, after reasonable efforts by BeiGene to transfer, or have transferred on its behalf, payments owed to Mirati hereunder, BeiGene will promptly notify Mirati of the conditions preventing such transfer and, at the request of Mirati, such payments will be deposited in local currency in the Licensed Territory to the credit of Mirati in a recognized banking institution designated by Mirati, or to a local currency account of a third party designated by Mirati.

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9.5    Royalty Records; Audits. BeiGene shall keep, and shall cause its Affiliates and Sublicensees to keep, complete and accurate records pertaining to the sales or other disposition of the Licensed Product in the Licensed Territory and calculation of Net Sales, in sufficient detail to permit Mirati to confirm the accuracy of royalty reports and payments due to it hereunder. Such records shall be kept for at least […***…] following the end of the Calendar Quarter to which they pertain. Mirati shall have the right to cause an independent, certified public accountant reasonably acceptable to BeiGene to audit such records to confirm Net Sales reports and royalty payments for a period covering not more than […***…] following the Calendar Quarter to which they pertain. Such audits may be exercised during normal business hours upon reasonable prior written notice to BeiGene; provided that such audit right may be exercised no more than […***…] or more than […***…] with respect to sales of a particular Licensed Product […***…]. All records made available for audit shall be deemed to be Confidential Information of BeiGene. Prompt adjustments shall be made by the Parties to reflect the results of such audit. Mirati shall bear the full cost of such audit unless such audit discloses an underpayment by BeiGene of more than […***…] percent ([…***…]%) of the amount of royalty payments due under this Agreement for any applicable Calendar Quarter, in which case, BeiGene shall bear the cost of such audit and shall promptly remit to Mirati the amount of any underpayment. Any overpayment by BeiGene revealed by an audit shall be credited against future payment owed by BeiGene to Mirati (and if no further payments are due, shall be promptly refunded by Mirati).
9.6    Interest on Late Payments. Any amounts not paid by either Party when due under this Agreement will be subject to interest from and after the date payment is due through and including the date upon which such Party makes such payment at the annual interest rate of […***…] percent ([…***…]%) […***…]; provided, however, that in no event shall such rate exceed the maximum legal annual interest rate.
10.    INTELLECTUAL PROPERTY
10.1    Ownership of Intellectual Property.
(a)    Data and Results. All data, results and other Know-How (and all property rights therein) generated in connection with any Development or Commercialization activities with respect to Licensed Product conducted by or on behalf of Mirati and its Affiliates and other licensees shall, as between Mirati and BeiGene, be the sole and exclusive property of, and to the extent BeiGene acquires or obtains any interest therein are hereby assigned to, Mirati or its Affiliates or licensees (other than BeiGene as licensee hereunder), as applicable, subject to the license and use rights granted to BeiGene hereunder. All BeiGene Data and Results (for clarity, excluding Manufacturing Data) shall be (as between the Parties) the sole and exclusive property of BeiGene or of its Affiliates or Sublicensees, as applicable, but subject to the license and use rights granted to Mirati hereunder. All Manufacturing Data generated in connection with any Development or Commercialization activities with respect to the Compound and/or Licensed Product conducted by or on behalf of BeiGene and its Affiliates and Sublicensees shall, as between Mirati and BeiGene, be the sole and exclusive property of Mirati, and BeiGene hereby assigns and agrees to assign to Mirati all rights, title and interest in and to all such Manufacturing Data (and all property rights therein), which rights are subject to the license and use rights granted to BeiGene herein. BeiGene shall ensure that its Affiliates and Sublicensees provide BeiGene with sufficient rights in all BeiGene Data and Results and Manufacturing Data so that BeiGene can transfer to Mirati, and grant it the rights to use, such BeiGene Data and Results

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and can assign to Mirati all rights and title in and to all Compound-Specific Inventions and Manufacturing Data, as provided in this Agreement.

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(b)    Patents, Inventions and other Know-How. Mirati (and its Affiliates) shall have sole and exclusive ownership of all right, title and interest on a worldwide basis in and to any and all Licensed Patent Rights, Licensed Know-How, Compound-Specific Inventions, Compound-Specific Patents, Mirati Inventions and Mirati Invention Patents. BeiGene shall have sole and exclusive ownership of all right, title and interest on a worldwide basis in and to any and all BeiGene Know-How, BeiGene Patents, BeiGene Inventions, and BeiGene Invention Patents. BeiGene (on behalf of itself and its Affiliates) hereby assigns and agrees to assign to Mirati all rights, title and interest in and to the Compound-Specific Inventions and Compound-Specific Patents. The Parties shall jointly own an undivided one-half interest in all Inventions made jointly by or on behalf of both Parties or their respective Affiliates and Controlled by each Party or their respective Affiliates (referred to herein as “Joint Inventions”), except for Compound-Specific Inventions and Compound-Specific Patents. All Patents claiming patentable Joint Inventions shall be referred to herein as “Joint Patents”, and shall be jointly owned by the Parties, subject to the applicable licenses granted by each Party hereunder. BeiGene shall ensure that its Affiliates and Sublicensees provide and assign to BeiGene all rights in Compound-Specific Inventions and Compound-Specific Patents so that BeiGene can transfer and assign to Mirati all rights, title and interest in and to all Compound-Specific Inventions and Compound Specific Patents, as provided in this Agreement. Except to the extent either Party is restricted by the licenses granted to the other Party under this Agreement, each Party shall be entitled to practice, license, assign, and otherwise exploit its interest under Joint Inventions and Joint Patents without the duty of accounting or seeking consent from the other Party.
10.2    Patent Prosecution and Maintenance.
(a)    Licensed Patents/Joint Patents.
(i)    Subject to the remainder of this Section 10.2(a), including subsection (ii), Mirati shall have the sole right, but not the obligation, to control the preparation, filing, prosecution, and maintenance (including any interferences, reissue proceedings, reexaminations, inter partes review, patent term extensions, applications for supplementary protection certificates, oppositions,) of the Licensed Patents and Joint Patents, including all Compound-Specific Invention Patents and Mirati Invention Patents, worldwide, at its sole cost and expense and using counsel of its own choice. In the event that Mirati desires to abandon or cease prosecution or maintenance of any Licensed Patent in the Licensed Territory during the Term, Mirati shall provide reasonable prior written notice to BeiGene of such intention to abandon (which notice shall, to the extent possible, be given no later than […***…] days prior to the next deadline for any action that must be taken with respect to any such Licensed Patent in the relevant patent office). In such case, upon BeiGene’s written election provided to Mirati no later than […***…] days after such notice from Mirati and subject to any rights of any Third Party with respect thereto, BeiGene shall have the right to continue prosecution and maintenance of such Licensed Patent at BeiGene’s direction and expense. If BeiGene does not provide such election within […***…] days after such notice from Mirati, Mirati may thereafter, in its sole discretion, continue or discontinue the prosecution and maintenance of such Licensed Patent.
(iI)    Notwithstanding anything to the contrary in this Section 10.2, in the event that any Joint Patent covers any patentable Joint Invention that relates to any proprietary compound of BeiGene, the Parties will discuss and agree in good faith upon the

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allocation between the Parties of prosecution, maintenance and enforcement responsibilities using patent counsel mutually acceptable to the Parties.

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(b)    BeiGene Patents.
(i)    Subject to this Section 1.1(b), BeiGene shall have the first right, but not the obligation, to control the preparation, filing, prosecution, and maintenance (including any interferences, reissue proceedings, reexaminations, inter partes review, patent term extensions, applications for supplementary protection certificates, oppositions, invalidation proceedings, and defense of validity or enforceability challenges) of all BeiGene Patents and BeiGene Invention Patents, worldwide, at its sole cost and expense and by counsel of its own choice.
(ii)    In the event that BeiGene desires to abandon or cease prosecution or maintenance of any BeiGene Invention Patent outside the Licensed Territory (other than any BeiGene Invention Patent that covers or relates to any proprietary compound of BeiGene) during the Term, BeiGene shall provide reasonable prior written notice to Mirati of such intention to abandon (which notice shall, to the extent possible, be given no later than […***…] days prior to the next deadline for any action that must be taken with respect to any such BeiGene Invention Patent in the relevant patent office). In such case, upon Mirati’s written election provided to BeiGene no later than […***…] days after such notice from BeiGene and subject to any rights of any Third Party with respect thereto, Mirati shall have the right to continue prosecution and maintenance of such BeiGene Invention Patent outside the Licensed Territory at Mirati’s direction and expense. If Mirati does not provide such election within […***…] days after such notice from BeiGene, BeiGene may, in its sole discretion, continue prosecution and maintenance of such BeiGene Patent or discontinue prosecution and maintenance of such BeiGene Patent.
(c)    Cooperation of the Parties. The Party that has the responsibility for the preparation, filing, prosecution, and maintenance of any Patents under Section 10.2(a), (b) or (c) above (the “Prosecuting Party”) shall (A) promptly provide the other Party (the “Non-Prosecuting Party”) with copies of all material submissions and correspondence with the applicable patent offices with respect to its preparation, filing, prosecution, and maintenance of the applicable Patents, in sufficient time to allow for review and comment by Non-Prosecuting Party, and (B) provide the Non-Prosecuting Party and its patent counsel with an opportunity to consult with the Prosecuting Party regarding such Patents and any amendment, submission or response with respect to such Patents. The advice and suggestions of the Non-Prosecuting Party and its patent counsel shall be taken into consideration in good faith by the Prosecuting Party in connection with such preparation, filing, prosecution, and maintenance; provided, that, if the Non-Prosecuting Party fails to provide any comment on or before the expiration of […***…] Business Days before the proposed date for any amendment, submission or response notified by the Prosecuting Party, the Prosecuting Party’s obligations under this Section 10.2(d) shall be deemed to have been fulfilled. The Prosecuting Party shall pursue in good faith all reasonable claims requested by the Non-Prosecuting Party in its preparation, filing, prosecution, and maintenance of any Patents under this subsection (d); provided, that, if the Prosecuting Party incurs any additional cost or expense as a result of any such request, the Non-Prosecuting Party shall be solely responsible for the cost and expense attributable to the pursuit of any such additional claim or taking such other activities. Each Party agrees otherwise to cooperate fully in the preparation, filing, prosecution, and maintenance of Patents under this Section 10.2 and in the obtaining and maintenance of any patent extensions, supplementary protection certificates, and the like with respect thereto, at its own costs. Such cooperation includes, but is not limited

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to, (i) executing all papers and instruments, or requiring its employees or contractors, to execute such papers and instruments, so as to enable the other

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Party to apply for and to prosecute patent applications in any country as permitted by Section 10.2, and (ii) promptly informing the other Party of any matters coming to such Party’s attention that may affect the preparation, filing, prosecution, or maintenance of any such patent applications and the obtaining of any patent term extensions, supplementary protection certificates, and their equivalent.
10.3    Infringement by Third Parties.
(a)    Notice; Enforcement Generally. Upon either Party becoming aware of any infringement or threatened infringement by a Third Party of (i) any BeiGene Patents, BeiGene Invention Patents, or Licensed Patents in the Licensed Territory, or (ii) Combination Product Patents or Joint Patents in the Licensed Territory or outside the Licensed Territory, such Party shall promptly notify the other Party thereof. Any such notice shall include evidence to support an allegation of infringement or threatened infringement by such Third Party. Except as expressly provided herein, each Party retains exclusive rights to enforce all of its intellectual property rights.
(b)    BeiGene Enforcement. Subject to this Section 10.3(b), as between the Parties, BeiGene shall have the first right, but not the obligation, to bring and control any action or proceeding with respect to infringement of any Licensed Patent (for clarity, including and Compound-Specific Patent), or Joint Patent in the Licensed Territory (including any invalidation proceedings, and defense of validity or enforceability challenges), and the sole right, but not the obligation, to bring and control any action or proceeding with respect to infringement of any BeiGene Patent or BeiGene Invention Patent worldwide, in each case at its own expense and by counsel of its own choice. Mirati shall have the right, at its own expense, to be represented in any action or proceeding with respect to a Licensed Patent (for clarity, including any Compound-Specific Patent) or Joint Patent in the Licensed Territory by counsel of its own choice, and the Parties shall reasonably cooperate with each other and the other’s counsel in strategizing, preparing for, and presenting any such action or proceeding. If BeiGene does not bring an action or proceeding with respect to infringement of any Licensed Patent (for clarity, including any Compound-Specific Patent), or Joint Patent in the Licensed Territory before the earlier of (i) […***…] days following the notice of alleged infringement or (ii) at least […***…] days before the time limit, if any, set forth in the Applicable Laws for the filing of such actions, whichever comes first, Mirati shall have the right to bring and control any such action at its own expense and by counsel of its own choice, and BeiGene shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. Except as otherwise agreed to by the Parties as part of a cost-sharing arrangement, any recovery or damages realized as a result of such action or proceeding with respect to Licensed Patents (for clarity, including any Compound-Specific Patents), or Joint Patents in the Licensed Territory shall be used first to reimburse the Parties’ documented out-of-pocket legal expenses relating to the action or proceeding on a pro-rata basis, and any remaining amounts shall be allocated as follows: (A) to the extent all or any portion of such recovery is attributable to loss of sales or profits with respect to a Licensed Product, […***…], and (B) any remaining amounts not allocated as provided above shall be shared by the Parties […***…].
(c)    Mirati Enforcement. Subject to this Section 10.3(c), as between the Parties, Mirati shall have the first right, but not the obligation, to bring and control any action

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or proceeding with respect to infringement of any Licensed Patent (for clarity, including any Compound-Specific Patent), or Joint Patent outside the Licensed Territory (including any invalidation proceedings, and defense of validity or enforceability challenges), in each case at its own expense and by counsel of its own choice, and BeiGene shall have the right, at its own expense, to be represented in any such action or proceeding with respect to an enforcement of a Joint Patent by counsel of its own choice. If Mirati does not bring an action or proceeding with respect to, or otherwise cause the cessation of, infringement of any Joint Patent outside the Licensed Territory before the earlier of (i) […***…] days following the notice of alleged infringement or (ii) at least […***…] days before the time limit, if any, set forth in the Applicable Laws for the filing of such actions, whichever comes first, BeiGene shall have the right to bring and control any such action with respect to, or otherwise cause the cessation of, infringement of Joint Patent at its own expense and by counsel of its own choice, and Mirati shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. Except as otherwise agreed to by the Parties as part of a cost-sharing arrangement, any recovery or damages realized as a result of such action or proceeding with respect to Joint Patents shall be used first to reimburse the Parties’ documented out-of-pocket legal expenses relating to the action or proceeding on a pro-rata basis, and any remaining amounts shall be allocated as follows (A) to the extent all or any portion of such recovery is attributable to loss of sales or profits with respect to a Licensed Product, […***…], and (B) any remaining amounts not allocated as provided above shall be allocated […***…]. For clarity, in no event shall BeiGene have the right to enforce any Licensed Patent (for clarity, including any Compound-Specific Patent) outside the Licensed Territory, which right shall be retained solely by Mirati, and Mirati retains sole and exclusive rights, at its discretion, to enforce all Patents of Mirati that are not Licensed Patents, anywhere in the world.
(d)    Cooperation. If a Party brings an infringement action in accordance with this Section 10.3, the other Party shall cooperate fully, including, if required to bring such action, the furnishing of a power of attorney or being named as a party to such action.
10.4    Infringement of Third Party Rights. Each Party shall promptly notify the other in writing of any allegation by a Third Party that the activity of BeiGene, Mirati, or any of their respective Affiliates or Sublicensees, as applicable, pursuant to this Agreement infringes or may infringe the intellectual property rights of a Third Party. BeiGene shall have the sole right to control any defense of any such claim against BeiGene (or its Affiliate or Sublicensee) involving alleged infringement of Third Party rights by activities of BeiGene or its Affiliate or Sublicensee in the Licensed Territory, at its own expense and by counsel of its own choice, and Mirati shall have the right (if such actions relate to Licensed Product), at its own expense, to be represented in any such action by counsel of its own choice. Subject to BeiGene’s indemnification obligations under Section 13.1, Mirati shall have the sole right to control any defense of any such claim against Mirati involving alleged infringement of Third Party rights by activities of Mirati or its Affiliates or other licensees at its own expense and by counsel of its own choice, and BeiGene shall have the right (if such actions relate to Licensed Product activities in the Licensed Territory), at its own expense, to be represented in any such action by counsel of its own choice.
10.5    Consent for Settlement. Neither Party shall enter into any settlement or compromise of any action or proceeding under this Article 10 that would in any material

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manner alter, diminish, or be in derogation of the other Party’s rights under this Agreement without the prior written consent of such other Party, which shall not be unreasonably withheld, conditioned, or delayed.
10.6    Trademarks. Except as provided […***…], and subject to Article 14, BeiGene shall own and be responsible for all trademarks, trade names, branding, or logos related to Licensed Product in the Field for use in the Licensed Territory, and will be responsible for selecting, registering, defending, and maintaining the same at BeiGene’s sole cost and expense. Mirati shall own and be responsible for all trademarks, trade names, branding, or logos related to Licensed Product in the Field for use outside the Licensed Territory, and will have the sole rights for selecting, registering, defending, and maintaining the same at Mirati’s sole cost and expense. […***…].
11.    CONFIDENTIALITY
11.1    Confidential Information. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, each of the Parties agrees that, during the Term and for […***…] thereafter, such Party and its Affiliates shall 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 Confidential Information of the other Party provided pursuant to this Agreement. Further, each of the Parties and its Affiliates shall keep confidential and, subject to Section 11.4, shall not publish or otherwise disclose the terms of this Agreement, except as otherwise permit in this Article 11. Each Party will use at least the same standard of care as it uses to protect proprietary or confidential information of its own proprietary or confidential information of a similar nature (but no less than reasonable care) to ensure that its employees, agents, consultants, contractors, and other representatives do not disclose or make any unauthorized use of the Confidential Information of the other Party. Each Party will promptly notify the other Party upon discovery of any unauthorized use or disclosure of any Confidential Information of the other Party and shall use diligent, good faith efforts to rectify such issue as soon as practicable.
11.2    Authorized Disclosure. Each Party may disclose Confidential Information belonging to the other Party as expressly permitted by this Agreement or if and to the extent such disclosure is reasonably necessary in the following instances:
(a)    filing, prosecuting, or maintaining Patents as permitted by this Agreement;
(b)    submitting Regulatory Filings for any Compound or Licensed Product in order to obtain or maintain Regulatory Approvals;
(c)    prosecuting or defending litigation as permitted by this Agreement;
(d)    complying with applicable court or administrative orders or governmental regulations (including regulations promulgated by securities exchanges); and

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(e)    disclosure to Affiliates, Sublicensees […***…] or […***…] other licensees, collaborators employees, consultants, contractors, or agents, on a need to know basis, or to potential Sublicensees […***…] or […***…] other licensees, or potential acquirers, merger partners other Third Party strategic partners, and their respective professional advisors, in connection with due diligence or similar investigations by such Third Parties in connection with potential business transactions, disclosure to actual or bona-fide potential Third Party investors in confidential financing documents, and disclosure to actual and bona-fide potential Third Party acquirers of such Party, provided, in each case, that any such Affiliate, Third Party Licensee, collaborator, employee, consultant, contractor, agent, or Third Party agrees to be bound by (or is subject to, pursuant to its professional ethical rules) terms of confidentiality and non-use consistent with those set forth in this Article 11.
Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Section 11.2(c) or 11.2(d), it will, except where impracticable, give reasonable advance notice to the other Party of such disclosure and use reasonable efforts to secure confidential treatment of such Confidential Information and at least as diligently as such Party would use to protect its own confidential information. In any event, each of the Parties agrees to take all reasonable action to avoid disclosure of the other Party’s Confidential Information hereunder except as needed in furtherance of, and in compliance with the terms of, this Agreement. Any information disclosed pursuant to Section 11.2(c) or 11.2(d) shall still be deemed Confidential Information and subject to the restrictions set forth in this Agreement, including the foregoing provisions of Article 11.
11.3    Publications.
(a)    Subject to Mirati’s review and approval as set forth below, BeiGene shall have the right to publish Clinical Data pertaining to the Compound or any Licensed Product and generated by or on behalf of BeiGene in the Licensed Territory pursuant to this Agreement and subject to this Section 11.3(a). Mirati shall have the right to review, comment on, and approve any material proposed for disclosure or publication by BeiGene regarding any such Clinical Data and/or results of and other information regarding BeiGene’s Development activities with respect to the Compound or any Licensed Product, whether by oral presentation, manuscript, or abstract. Before any such material is submitted for publication or presentation of the same is made, BeiGene shall deliver a complete copy to Mirati at least […***…] days prior to submitting the material to a publisher or initiating any other disclosure. Mirati shall review any such material and give its comments to BeiGene within […***…] days of receipt of such material. With respect to oral presentation materials and abstracts, Mirati shall make reasonable efforts to expedite review of such materials and abstracts, and shall return such items as soon as practicable to BeiGene with appropriate comments, if any, but in no event later than […***…] days from receipt. BeiGene shall comply with Mirati’s request to delete references to its Confidential Information in any such material and agrees to delay any submission for publication or other public disclosure for a period of up to an additional […***…] days for the purpose of preparing and filing appropriate patent applications.
(b)    Subject to BeiGene’s review and approval as set forth below, Mirati shall have the right to publish preclinical data and Clinical Data pertaining to the Compound or any Licensed Product that is generated by or on behalf of BeiGene or any of its Affiliates or Sublicensees pursuant to this Agreement and subject to this Section 11.3(b). BeiGene shall have the right to review, comment on, and approve any material proposed for disclosure or publication

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by Mirati regarding any such preclinical and Clinical Data, whether by oral presentation, manuscript, or abstract. Before any such material is submitted for publication or

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presentation of the same is made, Mirati shall deliver a complete copy to BeiGene at least […***…] days prior to submitting the material to a publisher or initiating any other disclosure. BeiGene shall review any such material and give its comments to Mirati within […***…] days of receipt of such material. With respect to oral presentation materials and abstracts, BeiGene shall make reasonable efforts to expedite review of such materials and abstracts, and shall return such items as soon as practicable to Mirati with appropriate comments, if any, but in no event later than […***…] days from receipt. Mirati shall comply with BeiGene’s request to delete references to its Confidential Information in any such material and agrees to delay any submission for publication or other public disclosure for a period of up to an additional […***…] days for the purpose of preparing and filing appropriate patent applications. In addition, Mirati shall keep BeiGene reasonably informed of any proposed publication of preclinical data and Clinical Data pertaining to the Compound or any Licensed Product and generated by or on behalf of Mirati and allow BeiGene the reasonable opportunity to review and discuss any material proposed for disclosure or publication by Mirati regarding any such preclinical data and Clinical Data, whether by oral presentation, manuscript, or abstract.
11.4    Publicity; Public Disclosures. The Parties agree to issue a joint press release promptly after the Effective Date, in the form attached as Exhibit 11.4 of this Agreement. Further, it is understood that each Party may desire or be required to issue subsequent press releases relating to this Agreement or the activities or results hereunder subject to the prior written consent of the other Party; provided, that (a) the Parties hereby agree to consult with each other with respect to the text and timing of any such subsequent press releases concerning activities or results pursuant to this Agreement, prior to the issuance thereof and (b) a Party may not unreasonably withhold, condition, or delay its consent to any such releases. Each Party may also make such disclosures relating to this Agreement or the activities or results hereunder to the extent required by Applicable Laws; provided, that such Party hereby agrees to use reasonable efforts to consult with the other Party with respect to the text and timing of any such disclosure.
11.5    Required Disclosures. Each Party acknowledges and agrees that the other Party may submit this Agreement to the U.S. Securities and Exchange Commission (the “SEC”) or any national securities exchange in any jurisdiction (collectively, the “Securities Regulators”), or to other Persons as may be required by Applicable Laws, and if a Party does submit this Agreement to any Securities Regulators, or other Persons as may be required by Applicable Laws, such Party agrees to reasonably consult and coordinate with the other Party with respect to the preparation and submission of a confidential treatment request for this Agreement. Notwithstanding the foregoing, if a Party determines that it is required by Applicable Laws or any Securities Regulator to make a disclosure of the terms of this Agreement in a filing or other submission as required by Applicable Laws or Securities Regulators, then such Party will have the right to make such disclosure at the time and in the manner reasonably determined by its counsel to be required by Applicable Laws or Securities Regulator subject to this Section 11.5. Each Party shall (a) provide copies of the proposed disclosure to the other Party reasonably in advance of such filing or other disclosure under the circumstances, (b) promptly notify the other Party in writing of such requirement and any respective timing constraints, and (c) give the other Party a reasonable time under the circumstances from the date of notice by such Party of the required disclosure to comment upon and request confidential treatment for such disclosure; provided, that, the other Party shall promptly review and provide comments regarding the proposed disclosure and the disclosing Party will in good faith consider incorporating such comments.

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11.6    Prior Confidentiality Agreement. As of the Effective Date, the terms of this Article 11 shall supersede any prior non-disclosure, secrecy, or confidentiality agreement between the Parties (or their Affiliates) dealing with the subject of this Agreement, including the Confidentiality Agreement. Any information disclosed pursuant to any such prior agreement shall be deemed Confidential Information for purposes of this Agreement.
11.7    Equitable Relief. Given the nature of the Confidential Information and the compe