Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

 

Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the quarterly period ended September 30, 2018

OR

 

Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the transition period from                to              .

Commission File Number: 001-37490

 

 

Sierra Oncology, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   20-0138994

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)

Sierra Oncology, Inc.

c/o 2150 – 885 West Georgia Street

Vancouver, British Columbia, Canada V6C 3E8

(Address of principal executive offices and zip code)

(604) 558-6536

(Registrant’s telephone number, including area code)

 

 

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days:    Yes  ☒    No  ☐

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files).    Yes  ☒    No  ☐

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer      Accelerated filer  
Non-accelerated filer      Smaller reporting company  
     Emerging growth company  

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 financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☒

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

As of November 6, 2018, there were 74,365,965 shares of the Registrant’s Common Stock, $0.001 par value per share, outstanding.

 

 

 


Table of Contents

TABLE OF CONTENTS

 

     Page  
Part I. Financial Information   

Item 1. Condensed Consolidated Financial Statements (unaudited)

     2  

Condensed Consolidated Balance Sheets

     2  

Condensed Consolidated Statements of Operations

     3  

Condensed Consolidated Statement of Stockholders’ Equity

     4  

Condensed Consolidated Statements of Cash Flows

     5  

Notes to Condensed Consolidated Financial Statements

     6  

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

     18  

Item 3. Quantitative and Qualitative Disclosures About Market Risk

     25  

Item 4. Controls and Procedures

     25  
Part II. Other Information   

Item 1. Legal Proceedings

     27  

Item 1A. Risk Factors

     27  

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

     61  

Item 3. Defaults Upon Senior Securities

     61  

Item 4. Mine Safety Disclosures

     61  

Item 5. Other Information

     61  

Item 6. Exhibits

     61  

Signatures

     63  

 


Table of Contents

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report on Form 10-Q (Quarterly Report) contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act), and section 27A of the Securities Act of 1933, as amended (Securities Act). All statements contained in this Quarterly Report other than statements of historical fact are “forward-looking statements” for purposes of this Quarterly Report on Form 10-Q. These forward-looking statements may include, but are not limited to, statements regarding our future clinical development activities, expected timing and results of clinical trials, future results of operations and financial position, our business strategy and plans and our objectives for future operations. The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan” “expect,” and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the “Risk Factors” section and elsewhere in this Quarterly Report on Form 10-Q. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements to conform these statements to actual results or to changes in our expectations, except as required by law. You should read this Quarterly Report with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.

As used in this Quarterly Report on Form 10-Q, the terms “Sierra Oncology,” “the Company,” “we,” “us” and “our” refer to Sierra Oncology, Inc., a Delaware corporation, and its subsidiaries taken as a whole, unless otherwise noted. Sierra Oncology is our registered trademark. The “Sierra Oncology” logo and all product names are our common law trademarks. This Quarterly Report may contain additional trade names, trademarks and service marks of other companies, which are the property of their respective owners. We do not intend our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, these other companies.

 

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PART I

 

ITEM 1.

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

SIERRA ONCOLOGY, INC.

Condensed Consolidated Balance Sheets

(unaudited)

(in thousands, except share and per share data)

 

     September 30,
2018
    December 31,
2017
 

ASSETS

    

CURRENT ASSETS:

    

Cash and cash equivalents

   $ 116,128     $ 100,348  

Prepaid expenses and other current assets

     3,203       1,377  
  

 

 

   

 

 

 

Total current assets

     119,331       101,725  

Property and equipment, net

     125       154  

Other assets

     596       319  
  

 

 

   

 

 

 

TOTAL ASSETS

   $ 120,052     $ 102,198  
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

CURRENT LIABILITIES:

    

Accrued liabilities

   $ 7,168     $ 6,133  

Accounts payable

     962       1,339  
  

 

 

   

 

 

 

Total current liabilities

     8,130       7,472  

Term loan

     4,856       —    
  

 

 

   

 

 

 

TOTAL LIABILITIES

     12,986       7,472  
  

 

 

   

 

 

 

Commitments and Contingencies (Note 7)

    

STOCKHOLDERS’ EQUITY:

    

Preferred stock, $0.001 par value; 10,000,000 shares authorized as of September 30, 2018 and December 31, 2017; nil shares issued and outstanding as of September 30, 2018 and December 31, 2017

     —         —    

Common stock, $0.001 par value; 500,000,000 shares authorized as of September 30, 2018 and December 31, 2017; 74,364,165 and 52,395,223 shares issued and outstanding as of September 30, 2018 and December 31, 2017

     74       52  

Additional paid-in capital

     770,121       718,751  

Accumulated deficit

     (663,129     (624,077
  

 

 

   

 

 

 

TOTAL STOCKHOLDERS’ EQUITY

     107,066       94,726  
  

 

 

   

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

   $ 120,052     $ 102,198  
  

 

 

   

 

 

 

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

 

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SIERRA ONCOLOGY, INC.

Condensed Consolidated Statements of Operations

(unaudited)

(in thousands, except share and per share data)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2018     2017     2018     2017  

Operating expenses:

        

Research and development

   $ 12,913     $ 7,405     $ 30,032     $ 22,607  

General and administrative

     3,138       2,778       10,736       9,207  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     16,051       10,183       40,768       31,814  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (16,051     (10,183     (40,768     (31,814

Other income, net

     479       225       1,333       506  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before provision for (benefit from) income taxes, net

     (15,572     (9,958     (39,435     (31,308

Provision for (benefit from) income taxes, net

     (5     37       (383     108  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (15,567   $ (9,995   $ (39,052   $ (31,416
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per common share, basic and diluted

   $ (0.21   $ (0.19   $ (0.56   $ (0.64
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average shares used in computing net loss per common share, basic and diluted

     74,347,489       52,268,443       69,517,119       49,080,049  
  

 

 

   

 

 

   

 

 

   

 

 

 

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

 

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SIERRA ONCOLOGY, INC.

Condensed Consolidated Statement of Stockholders’ Equity

(unaudited)

(in thousands, except share data)

 

     Common Stock      Additional
Paid-In
Capital
     Accumulated
Deficit
    Total
Stockholders’
Equity
 
     Shares      Amount                      

Balance—December 31, 2017

     52,395,223      $ 52      $ 718,751      $ (624,077   $ 94,726  

Issuance of common stock for exercise of stock options

     118,942        —          178        —         178  

Stock-based compensation

     —          —          5,102        —         5,102  

Issuance of common stock, net of offering costs of $3.2 million

     21,850,000        22        45,974        —         45,996  

Issuance of common stock warrant

     —          —          116        —         116  

Net loss

     —          —          —          (39,052     (39,052
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

Balance—September 30, 2018

     74,364,165      $ 74      $ 770,121      $ (663,129   $ 107,066  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

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

 

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SIERRA ONCOLOGY, INC.

Condensed Consolidated Statements of Cash Flows

(unaudited)

(in thousands)

 

     Nine Months Ended
September 30,
 
     2018     2017  

CASH FLOWS FROM OPERATING ACTIVITIES:

    

Net loss

   $ (39,052   $ (31,416

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

    

Stock-based compensation

     5,102       4,498  

Depreciation

     85       228  

Other

     (167     30  

Changes in operating assets and liabilities:

    

Prepaid expenses and other assets

     (1,831     (483

Accrued liabilities

     1,092       681  

Accounts payable

     (371     (2,093
  

 

 

   

 

 

 

Net cash used in operating activities

     (35,142     (28,555
  

 

 

   

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

    

Purchase of property and equipment

     (59     (92
  

 

 

   

 

 

 

Net cash used in investing activities

     (59     (92
  

 

 

   

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

    

Proceeds from issuance of common stock upon follow-on offering, net of offering costs

     45,996       27,422  

Proceeds from issuance of term loan, net of issuance costs

     4,955       —    

Proceeds from exercise of common stock options

     178       23  
  

 

 

   

 

 

 

Net cash provided by financing activities

     51,129       27,445  
  

 

 

   

 

 

 

Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash

     (36     6  

NET INCREASE / (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH

     15,892       (1,196

CASH, CASH EQUIVALENTS AND RESTRICTED CASH — Beginning of period

     100,536       109,207  
  

 

 

   

 

 

 

CASH, CASH EQUIVALENTS AND RESTRICTED CASH — End of period

   $ 116,428     $ 108,011  
  

 

 

   

 

 

 

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:

    

Cash paid for income taxes, net

   $ 15     $ 221  
  

 

 

   

 

 

 

Cash paid for interest

   $ 9     $ —    
  

 

 

   

 

 

 

SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION:

    

Property and equipment purchases included in accrued liabilities

   $ —       $ 5  
  

 

 

   

 

 

 

Issuance of common stock warrant

   $ 116     $ —    
  

 

 

   

 

 

 

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

 

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SIERRA ONCOLOGY, INC.

Notes to Condensed Consolidated Financial Statements

(unaudited)

1. The Company and Basis of Presentation

Organization and Description of Business

Sierra Oncology, Inc. (together with its subsidiaries, collectively referred to as the “Company”), a Delaware corporation, is a clinical stage drug development company advancing targeted therapeutics for the treatment of patients with unmet medical needs in hematology and oncology. Pursuant to an asset purchase agreement entered into in August 2018 (Note 7), Sierra Oncology acquired its lead drug candidate, momelotinib, a potent, selective and orally-bioavailable JAK1, JAK2 and ACVR1 inhibitor that has been investigated in two completed Phase 3 trials for the treatment of myelofibrosis and has demonstrated a potentially differentiated therapeutic profile encompassing anemia-related benefits, as well as achieving substantive spleen and constitutional symptom control. Sierra Oncology is also advancing SRA737 and SRA141. SRA737 is a potent, highly selective, orally bioavailable small molecule inhibitor of Checkpoint kinase 1 (Chk1), a key regulator of cell cycle progression and the DNA Damage Response (DDR) replication stress response. SRA141 is a potent, selective and orally bioavailable small molecule inhibitor of cell division cycle 7 kinase (Cdc7), a key regulator of DNA replication and involved in the DDR network.

The Company’s primary activities since inception have been conducting research and development activities, conducting preclinical and clinical testing, recruiting personnel, performing business and financial planning, identifying and evaluating additional drug candidates for potential in-licensing or acquisition, and raising capital to support development activities.

The Company has not generated any product revenue related to its primary business purpose to date, nor has it generated any income, and is subject to a number of risks and uncertainties, which include dependence on key individuals, the need to identify and successfully develop commercially viable products, the need to obtain regulatory approval for its products and commercialize them, and the need to obtain adequate additional financing to fund the development of its product candidates.

As of September 30, 2018, the Company had $116.1 million of cash and cash equivalents. The Company believes that its balance of cash and cash equivalents as of the date of the issuance of these condensed consolidated financial statements is sufficient to fund its current operational plan for at least the next twelve months though it may pursue raising additional capital through equity financings or other arrangements.

Follow-On Offering

On March 6, 2018, the Company completed an underwritten public offering of an aggregate of 21,850,000 shares of common stock, including the underwriters’ exercise of their overallotment option, at a price to the public of $2.25 per share. The aggregate net proceeds received by the Company from the offering were $46.0 million, net of underwriting discounts and commissions and offering expenses of $3.2 million.

2. Summary of Significant Accounting Policies

Basis of Presentation

The condensed consolidated balance sheet as of September 30, 2018, the condensed consolidated statements of operations for the three and nine months ended September 30, 2018 and 2017, the condensed consolidated statements of cash flows for the nine months ended September 30, 2018 and 2017 and the condensed consolidated statement of stockholders’ equity as of September 30, 2018 are unaudited. The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s condensed consolidated financial statements included in this report. The condensed consolidated financial data disclosed in these notes to the condensed consolidated financial statements related to the three-and nine-month periods are also unaudited. The condensed consolidated results of operations for the three and nine months ended September 30, 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2018, or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 2017 included herein was derived from the audited consolidated financial statements as of that date. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on February 27, 2018.

 

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Use of Estimates

The preparation of the condensed consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expense during the reporting period. Significant estimates and assumptions made in the accompanying condensed consolidated financial statements include, but are not limited to the fair value of stock options and the warrant issued, accruals such as research and development costs, and recoverability of the Company’s net deferred tax assets and related valuation allowance. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates.

Foreign Currency

The functional currency of the Company’s foreign subsidiaries is the U.S. Dollar. Transactions denominated in currencies other than the functional currency are recorded at prevailing exchange rates during the period. At the end of each reporting period, monetary assets and liabilities are remeasured to the functional currency using exchange rates in effect at the balance sheet date. Non-monetary assets and liabilities are recorded at historical exchange rates. Gains and losses related to remeasurement are recorded in other income, net in the condensed consolidated statements of operations. The net foreign exchange transaction gains (losses) included in other income, net in the accompanying condensed consolidated statements of operations was insignificant for the three and nine months ended September 30, 2018 and 2017.

Cash and Cash Equivalents

The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents consist primarily of funds invested in readily available checking and savings accounts and highly liquid investments in money market funds.

Restricted Cash

Restricted cash, which consists of funds invested in a money market fund, represents collateral for a corporate credit card facility. Restricted cash at December 31, 2017 also included security deposits required for a facility lease that expired in February 2018.

Concentrations of Credit Risk

Financial instruments that subject the Company to significant concentrations of credit risk consist of cash, cash equivalents and restricted cash. All of the Company’s cash, cash equivalents and restricted cash are held at financial institutions in the United States and Canada that management believes to be of high credit quality. Deposits held in the United States and Canada with these financial institutions exceed federally insured limits.

The primary focus of the Company’s investment strategy is to preserve capital and meet liquidity requirements. The Company’s investment policy addresses the level of credit exposure by limiting the concentration in any one corporate issuer and establishing a minimum allowable credit rating.

Comprehensive Loss

The Company had no components of comprehensive loss other than net loss for all periods presented.

Fair Value of Financial Instruments

The Company’s cash and cash equivalents, restricted cash, other current assets, accounts payable, and accrued liabilities approximate their fair value due to their short duration. The term loan bears interest at prevailing market rates for instruments with similar characteristics, accordingly, the carrying value of this instrument approximates its fair value.

 

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The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value of its financial instruments based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels:

Level  1 – Inputs are unadjusted quoted prices in active markets for identical assets or liabilities at the measurement date;

Level  2 – Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and

Level  3 – Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data.

Property and Equipment, Net

Property and equipment, net are stated at cost, less accumulated depreciation. Depreciation on property and equipment, excluding leasehold improvements, is computed using the straight-line method over the estimated useful lives of the respective assets, generally three to five years. Depreciation begins at the time the asset is placed in service. Maintenance and repairs are charged to operations as incurred. Upon sale or retirement of assets, the cost and related accumulated depreciation are removed from the condensed consolidated balance sheet and the resulting gain or loss is reflected in the condensed consolidated statement of operations. Leasehold improvements are amortized on a straight-line basis over the shorter of the estimated useful lives of the assets or the remaining lease term.

Other Assets

Other assets consist primarily of restricted cash pledged as collateral for a corporate credit card facility, long-term prepaid rent and deferred income tax assets in foreign jurisdictions.

Research and Development Costs

Research and development costs are expensed as incurred. The Company accounts for non-refundable advance payments for goods and services that will be used in future research and development activities as expenses when the goods have been received or when the service has been performed rather than when the payment is made. Depending on the timing of payments to service providers of research and development costs, the Company recognizes prepaid expenses or accrued expenses related to these costs. These prepaid or accrued expenses are based on management’s estimates of the work performed under service agreements and milestones achieved. In the event that a clinical trial is terminated early, the Company records an accrual for the estimated remaining costs to complete the trial in the period of termination.

Upfront payments made in connection with license and asset purchase agreements are expensed as research and developments costs, as the assets acquired do not have alterative future use. Contingent milestone payment obligations due to third parties under license and asset purchase agreements are expensed when the milestones are considered probable of occurring.

Research and development costs include fees incurred in connection with license and asset purchase agreements, compensation and other related costs for employees engaged in research and development, costs associated with research and preclinical studies, clinical trials, regulatory activities, manufacturing activities to support clinical activities, fees paid to external service providers that conduct certain research and development, clinical, and manufacturing activities on behalf of the Company and an allocation of overhead expenses.

Stock-Based Compensation

The Company accounts for stock-based payments at fair value, which is measured using the Black-Scholes option-pricing model. For stock-based awards that vest subject to the satisfaction of a service requirement, the fair value measurement date for employee stock-based compensation awards is the date of grant and the expense is recognized on a straight-line basis over the vesting period.

For stock-based awards that vest subject to the satisfaction of a service requirement and a performance component, the fair value measurement date is the date of grant and is recognized over the requisite service period as achievement of the performance objective becomes probable.

Stock-based compensation arrangements with non-employees are recognized at the grant date and remeasured to fair value at each reporting period. The expense is recognized over the vesting period, which is generally the service period.

 

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Income Taxes

The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Management makes an assessment of the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s historical operating performance and the recorded cumulative net losses in prior fiscal periods, the net U.S. deferred tax assets have been offset by a full valuation allowance.

The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Changes in recognition or measurement are reflected in the period in which judgment occurs. The Company recognizes interest and penalties related to the underpayment of income taxes as a component of provision for (benefit from) income taxes, net.

Segment Information

Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision maker in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer.

The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment, which is the business of researching, developing and commercializing therapies for the treatment of patients with hematology and oncology. Accordingly, the Company has a single reporting segment.

Recent Accounting Pronouncements Not Yet Effective

In February 2016, the Financial Accounting Standards Board (FASB) issued FASB Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842) . The amendments in this update require that organizations recognize lease assets and lease liabilities on the balance sheet and disclose key information about leasing arrangements. This ASU is effective for financial statements issued for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, with early adoption permitted. The Company will adopt the new standard effective January 1, 2019 and expects its operating leases, as disclosed in Note 7 “Commitments and Contingencies”, to be subject to the new standard. The Company will recognize right-of-use assets and operating lease liabilities on its consolidated balance sheets upon adoption, which will increase its total assets and liabilities.

In June 2018, the FASB issued FASB ASU No. 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. This ASU is intended to simplify aspects of share-based compensation issued to non-employees by making the guidance consistent with accounting for employee share-based compensation. This ASU is effective for financial statements issued for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, with early adoption permitted. The Company will adopt the new standard effective January 1, 2019 and does not expect that the adoption of this new accounting guidance will have a material impact on its consolidated financial statements.

3. Net Loss Per Share

Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period without consideration for common stock equivalents. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. For purposes of this calculation, stock options and the warrant for common stock are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive.

 

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The following shares of common stock equivalents were excluded from the calculation of diluted net loss per share for the periods presented because including them would have been antidilutive:

 

     September 30,
2018
     September 30,
2017
 
     (in thousands)  

Options to purchase common stock

     10,719,737        7,685,449  

Warrant for common stock

     73,529        —    
  

 

 

    

 

 

 

Total potential dilutive shares

     10,793,266        7,685,449  
  

 

 

    

 

 

 

4. Fair Value Measurements

The Company measures and reports its cash equivalents and restricted cash at fair value. The following table sets forth the fair value of the Company’s financial assets measured on a recurring basis by level within the fair value hierarchy:

 

     September 30, 2018  
     Level 1      Level 2      Level 3      Total  
     (in thousands)  

Financial Assets

  

Money market funds

   $ 115,019      $ —      $ —      $ 115,019  

Restricted money market funds

     300        —          —          300  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial assets

   $ 115,319      $ —      $ —      $ 115,319  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

     December 31, 2017  
     Level 1      Level 2      Level 3      Total  
     (in thousands)  

Financial Assets

  

Money market funds

   $ 99,792      $ —        $ —        $ 99,792  

Restricted money market funds

     187        —          —          187  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial assets

   $ 99,979      $ —        $ —        $ 99,979  
  

 

 

    

 

 

    

 

 

    

 

 

 

Money market funds and restricted money market funds are measured at fair value on a recurring basis using quoted prices and are classified as a Level 1 input.

There were no transfers between Levels 1, 2 or 3 during the nine months ended September 30, 2018.

5. Balance Sheet Components

Cash and Cash Equivalents

Cash and cash equivalents consist of the following:

 

     September 30,
2018
     December 31,
2017
 
     (in thousands)  

Cash

   $ 1,109      $ 556  

Cash equivalents:

     

Money market accounts

     115,019        99,792  
  

 

 

    

 

 

 

Total cash and cash equivalents

   $ 116,128      $ 100,348  
  

 

 

    

 

 

 

 

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In November 2016, the FASB issued new guidance ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash , which requires the beginning-of-period and end-of-period totals on the statement of cash flows to include restricted cash and restricted cash equivalents, as well as disclosure of how the statement of cash flows reconciles to the balance sheet if restricted cash is shown separately from cash and cash equivalents on the balance sheet. The company adopted the guidance effective January 1, 2018 retrospectively to all periods presented. As a result, the condensed consolidated statement of cash flows no longer presents transfers to or from restricted cash.

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the condensed consolidated balance sheets to the amounts shown in the condensed consolidated statements of cash flows.

 

     September 30,
2018
     September 30,
2017
 
     (in thousands)  

Cash and cash equivalents

   $ 116,128      $ 107,824  

Restricted cash included in other assets

     300        187  
  

 

 

    

 

 

 

Total cash, cash equivalents and restricted cash shown in the condensed consolidated statement of cash flows

   $ 116,428      $ 108,011  
  

 

 

    

 

 

 

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following:

 

     September 30,
2018
     December 31,
2017
 
     (in thousands)  

Prepaid research and development project costs

   $ 1,106      $ 549  

Prepaid insurance

     815        478  

Other receivables

     407        103  

Income taxes receivable

     294        —    

Other

     581        247  
  

 

 

    

 

 

 

Total prepaid expenses and other current assets

   $ 3,203      $ 1,377  
  

 

 

    

 

 

 

Property and Equipment, net

Property and equipment, net consists of the following:

 

     September 30,
2018
     December 31,
2017
 
     (in thousands)  

Software

   $ 259      $ 254  

Leasehold improvements

     108        79  

Computer equipment

     89        93  

Furniture and fixtures

     3        3  
  

 

 

    

 

 

 

Property and equipment, gross

     459        429  

Less: accumulated depreciation

     (334      (275
  

 

 

    

 

 

 

Total property and equipment, net

   $ 125      $ 154  
  

 

 

    

 

 

 

Depreciation related to the Company’s property and equipment was $26,000 and $0.1 million for the three and nine months ended September 30, 2018, and $0.1 million and $0.2 million for the three and nine months ended September 30, 2017.

 

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Accrued Liabilities

Accrued liabilities consist of the following:

 

     September 30,
2018
     December 31,
2017
 
     (in thousands)  

Accrued research and development costs

   $ 3,589      $ 2,763  

Accrued employee-related costs

     2,133        2,699  

Accrued professional fees

     617        317  

Accrued restructuring costs (Note 11)

     71        137  

Other

     758        217  
  

 

 

    

 

 

 

Total accrued liabilities

   $ 7,168      $ 6,133  
  

 

 

    

 

 

 

6. Term Loan

On August 21, 2018, the Company entered into a Loan and Security Agreement (Loan Agreement) with Silicon Valley Bank (SVB), pursuant to which the Company may obtain a loan of aggregate principal amount of up to $15.0 million (Term Loans), which becomes available in three tranches, each of an aggregate principal amount of up to $5.0 million. Contemporaneously with executing the Loan Agreement, the Company drew down the first $5.0 million tranche. The second and third $5.0 million tranches may be drawn only upon the achievement of certain development milestones. Borrowings under the Loan Agreement bear interest at the greater of (i) 6.0% or (ii) a floating per annum rate 1.0% above the prime rate (for an interest rate of 6.25% at September 30, 2018), with interest only due and payable monthly, until March 1, 2020 (unless extended under the conditions set forth in the Loan Agreement), at which time interest and principal will be due and payable monthly in equal monthly payments; are subject to a final payment fee equal to 6.75% of the aggregate principal amount.

The Company may prepay all, but not less than all, of the loaned amounts subject to a prepayment fee in the amount of 3.0% of the outstanding principal balance if such prepayment occurs prior to August 21, 2019; 2.0% of the outstanding principal balance if such prepayment occurs on or after August 21, 2019, but prior to August 21, 2020; or 1.0% of the outstanding principal balance if such prepayment occurs on August 21, 2020 or at any time thereafter prior to the maturity date of the Term Loans on August 1, 2022. The Loan Agreement is secured by substantially all of the Company’s personal property, except for its intellectual property and requires the Company to maintain the lesser of $10 million or 80% of its cash and cash equivalents with SVB. The Loan Agreement contains customary covenants that limit the Company’s ability to dispose of assets, enter into mergers or acquisitions, incur indebtedness, incur liens, pay dividends or make distributions on the Company’s capital stock, make investments or loans, and enter into certain affiliate transactions, among others. The Loan Agreement contains customary events of default that include, among others, non-payment defaults, covenant defaults, the occurrence of a material adverse change, and inaccuracy of representations and warranties. The occurrence of an event of default could result in an increase to the applicable interest rate of 5.0%, and the consequent obligation for the Company to repay all amounts outstanding under the Loan Agreement.

In connection with the Loan Agreement, the Company issued a warrant to SVB to purchase 73,529 of the Company’s common stock at a price per share of $1.87. The warrant was immediately exercisable, will expire on August 21, 2028, contains a cashless exercise provision and is classified as equity. If the Company is to draw the second or third tranche available under the Loan Agreement, the Company will grant an additional amount of common stock issuable upon exercise of the warrant based upon the principal amount advanced. In no event will the number of common stock issuable pursuant to the exercise of the warrant exceed 220,588 in aggregate.

The fair value of the warrant and the debt issuance costs were recorded as debt discounts and together with the final payment fee are being amortized using the effective interest rate method over the term of the loan. As of September 30, 2018, the effective interest rate on the initial tranche of the loan was 9.38% and the unamortized debt discount was $0.2 million. Amortization of the debt discount and accrual of final payment was $17,000 for the three months ended September 30, 2018.

 

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Scheduled payments due under the Loan Agreement, excluding the final payment fee of $0.3 million and interest payments, are as follows:

 

     September 30, 2018  
     (in thousands)  

2020

   $ 1,667  

2021

     2,000  

2022

     1,333  
  

 

 

 

Total

   $ 5,000  
  

 

 

 

During the three and nine months ended September 30, 2018, the Company recognized $0.1 million of interest expense related to the Loan Agreement.

7. Commitments and Contingencies

Asset Purchase Agreement

In August 2018, the Company entered into an asset purchase agreement with Gilead Sciences, Inc. (Gilead) whereby the Company acquired worldwide rights to the pharmaceutical product momelotinib, an investigational inhibitor of Janus kinase, together with all related intellectual property rights and certain other related assets. The Company paid Gilead an upfront payment of $3.0 million in August 2018. The related expense was included in research and development for the three and nine months ended September 30, 2018 in the accompanying condensed consolidated statement of operations. The Company will be required to pay Gilead milestone payments of up to an aggregate of $195.0 million upon the achievement of certain development, regulatory and commercial milestones events, including a milestone payment of $5.0 million upon the dosing of the first patient in a registrational clinical trial. These milestones will be accrued once they are considered probable of occurring. In addition, the Company is required to pay Gilead mid-teen to high twenty percent tiered royalties based upon net sales.

License Agreements

In September 2016, the Company entered into an exclusive license agreement with CRT Pioneer Fund LP (CPF) for worldwide rights, know-how and materials to develop SRA737, a small molecule inhibitor targeting Chk1, a promising therapeutic target to treat cancer. Pursuant to the agreement, the Company made a one-time upfront payment of $7.0 million to CPF in October 2016 and paid $2.0 million to CPF in January 2017 for the successful transfer of two ongoing Phase I clinical trials. The expense related to these payments was included in research and development for the year ended December 31, 2016. Additional milestone payments of up to an aggregate of $319.5 million may become payable to CPF upon the achievement of certain developmental, regulatory and commercial milestones, and will be accrued once they are considered probable of occurring. In addition, the Company is required to pay CPF, on a product-by-product and country-by-country basis, tiered high single-digit to low double-digit royalties on the net sales of any product successfully developed.

In May 2016, the Company entered into an exclusive license agreement (Carna License Agreement) with Carna Biosciences, Inc. (Carna) for worldwide rights to develop and commercialize SRA141, a small molecule kinase inhibitor targeting Cdc7. In exchange for this exclusive right, the Company paid Carna an upfront payment of $0.9 million in June 2016. The Company will be required to pay Carna milestone payments of up to an aggregate of $270.0 million upon achievement of certain developmental, regulatory and commercial milestone events, including a milestone payment of $4.0 million upon dosing of the first patient in the first Phase 1 clinical trial for SRA141. These milestones will be accrued once they are considered probable of occurring. As of September 30, 2018, the Company had not recorded any milestone payments to Carna. In addition, the Company is required to pay Carna tiered single-digit royalties on net sales of product candidates (as defined under the Carna License Agreement).

Lease Agreements

In February 2015, the Company entered into an operating lease agreement to sublease office space in Vancouver, Canada. Under the terms of the agreement, the Company issued a letter of credit to the sublessor on closing, which was collateralized by a restricted deposit. The operating lease agreement together with the restricted deposit expired on February 2018. In June 2017, the Company entered into a new operating lease agreement to continue leasing the office space in Vancouver, Canada commencing March 1, 2018. The new lease expires on February 28, 2023 and can be extended for an additional term of 5 years.

In January 2016, the Company entered into an operating lease agreement to lease office space near San Francisco, California. The operating lease agreement expires on April 30, 2019. In September 2017, the Company entered into a sublease agreement to sublet the premises to a third party until April 30, 2019. The fair value of the remaining contractual obligation, net of sublease income, was included in accrued liabilities in the accompanying condensed consolidated balance sheet as of September 30, 2018.

 

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In addition to base rent, these leases require payment of taxes and other operating costs. These operating costs are not included in the table below.

As of September 30, 2018, the aggregate future non-cancelable minimum lease payments associated with these operating leases are as follows:

 

Years Ending December 31:

   Operating Leases  
     (in thousands)  

Remainder of 2018

   $ 102  

2019

     266  

2020

     219  

2021

     223  

2022

     178  

Thereafter

     —    
  

 

 

 

Total (a)

   $ 988  
  

 

 

 

 

(a)

Minimum lease payments have not been reduced by minimum sublease rentals of $0.1 million due in the future under sublease.

The total rent expense was $0.1 million and $0.3 million for the three and nine months ended September 30, 2018, and $0.1 million and $0.4 million for the three and nine months ended September 30, 2017.

Legal

On November 9, 2016, a purported securities class action lawsuit was filed in the United States District Court for the Southern District of New York against the Company and certain of its executive officers (the New York Lawsuit). The New York Lawsuit was brought by purported stockholders of the Company seeking to represent a class consisting of stockholders who purchased stock between July 15, 2015 and June 6, 2016. The New York Lawsuit asserts claims under Sections 10(b) and 20(a) of the Exchange Act and seeks unspecified damages and other relief. On March 13, 2018, the United States District Court for the Southern District of New York granted the defendants’ motion to dismiss and entered a final judgment dismissing the New York Lawsuit with prejudice. Plaintiffs have filed an appeal. The Company believes that the claims in the New York Lawsuit are without merit and intends to defend the lawsuit vigorously. It is possible that additional similar lawsuits could be filed. Due to the early stage of the litigation, the Company is unable to predict the outcome of this matter. However, at this point in time, the Company does not expect the outcome of these claims will have a material impact on its condensed consolidated financial statements.

On November 18, 2016, a purported securities class action lawsuit was filed in the Superior Court of the State of California for the County of San Mateo against the Company, certain of its executive officers and directors, and the underwriters for the Company’s initial public offering of its common stock. On February 9, 2017, a substantially identical putative class action suit was filed in the Superior Court of the State of California for the County of San Mateo asserting the same claims on behalf of the same putative class (the two lawsuits together, the California Lawsuits). The California Lawsuits were brought by purported stockholders of the Company seeking to represent a class consisting of stockholders who purchased stock pursuant to and/or traceable to the Company’s Registration Statement on Form S-1. The lawsuits assert claims under Sections 11 and 15 of the Exchange Act and seek unspecified damages and other relief. On August 1, 2018, all parties reached a mutually acceptable resolution to the California Lawsuits by way of a mediated settlement, which is subject to the parties’ execution of final settlement documents and the approval of the court. While the Company believes that the claims are without merit, it believes settlement will reduce the ultimate cost and distraction of further litigation. The Company does not expect its portion of the settlement amount to have a material impact on its condensed consolidated financial statements.

From time to time, the Company may become subject to other legal proceedings, claims and litigation arising in the ordinary course of business. In addition, the Company may receive letters alleging infringement of patent or other intellectual property rights. The Company is not currently a party to any other material legal proceedings, nor is it aware of any pending or threatened litigation that, in the Company’s opinion, would have a material adverse effect on the business, operating results, cash flows or financial condition should such litigation be resolved unfavorably.

 

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8. Common Stock Reserved for Issuance

The Company is required to reserve and keep available out of its authorized but unissued shares of common stock a number of shares sufficient to effect the conversion of all outstanding options granted and available for grant under the incentive plans, shares reserved for issuance under the employee stock purchase plan and issued warrant.

 

     September 30,
2018
     December 31,
2017
 

Outstanding stock options under the 2015 equity incentive plan

     10,719,737        7,470,601  

Shares reserved for future option grants under equity plans

     1,731,500        1,503,770  

Shares reserved under the 2015 employee stock purchase plan

     700,000        700,000  

Shares reserved under warrant upon contingent events

     147,059        —    

Outstanding warrant

     73,529        —    
  

 

 

    

 

 

 

Total common stock reserved for issuance

     13,371,825        9,674,371  
  

 

 

    

 

 

 

9. Stock-Based Compensation

In the accompanying condensed consolidated statements of operations, the Company recognized stock-based compensation expense for its employees and non-employees as follows:

 

     Three Months Ended
September 30,
     Nine Months Ended
September 30,
 
     2018      2017      2018      2017  
     (in thousands)  

Research and development

   $ 1,168      $ 1,003      $ 3,330      $ 3,024  

General and administrative

     653        457        1,772        1,474  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total stock-based compensation

   $ 1,821      $ 1,460      $ 5,102      $ 4,498  
  

 

 

    

 

 

    

 

 

    

 

 

 

Determination of Fair Value

The estimated grant-date fair values of all of the Company’s stock-based awards were calculated using the Black-Scholes option pricing model, based on assumptions as follows:

 

     Three Months Ended
September 30,
     Nine Months Ended
September 30,
 
     2018      2017      2018      2017  

Expected term (in years)

     5.6 – 6.1        6.1        5.3 – 7.0        5.3 –7.0  

Expected volatility

     88 – 91%        87%        88 – 91%        86 – 96%  

Risk-free interest rate

     2.7 – 3.0%        1.8 – 2.1%        2.6 – 3.0%        1.8 – 2.3%  

Expected dividend rate

     —  %        —  %        —  %        —  %  

Equity Incentive Plans

2018 Equity Inducement Plan

In September 2018, the Company’s Compensation Committee approved the 2018 Equity Inducement Plan (2018 Plan). The number of shares available for awards under the 2018 Plan was set to 1,500,000. The exercise price of each stock-based award issued under the 2018 Plan is required to be no less than the fair value of the Company’s capital stock. The vesting and exercise provisions of options or restricted awards granted are determined individually with each grant. Stock options have a 10-year life and expire if not exercised within that period or if not exercised within three months of cessation of employment with the Company or such longer period of time as specified in the option agreement. As of September 30, 2018, there were no awards issued or outstanding under the 2018 Plan.

2015 Plan

The 2015 Equity Incentive Plan (2015 Plan) became effective on July 14, 2015. As of September 30, 2018, 8,636,226 shares were reserved for issuance under the 2015 Plan. The number of shares reserved for issuance under the 2015 Plan will increase automatically on January 1 of each calendar year 2016 through 2025 by the number of shares equal to 4% of the total outstanding shares of the Company’s common stock as of the immediately preceding December 31. The Company’s Board of Directors or Compensation Committee may reduce the amount of the increase in any particular year. The exercise price of each stock-based award issued under

 

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the 2015 Plan is required to be no less than the fair value of the Company’s capital stock. The vesting and exercise provisions of options or restricted awards granted are determined individually with each grant. Stock options have a 10-year life and expire if not exercised within that period or if not exercised within three months of cessation of employment with the Company or such longer period of time as specified in the option agreement.

2008 Plan

The Company granted options under the 2008 Stock Plan (2008 Plan) until July 2015 when it was terminated as to future awards, although it continues to govern the terms of options that remain outstanding under the 2008 Plan. The 2008 Plan provided for the granting of Incentive Stock Options (ISO), nonqualified stock options and stock purchase rights. In connection with the Board of Director’s approval of the 2015 Plan, all remaining shares available for future award under the 2008 Plan were transferred to the 2015 Plan, and the 2008 Plan was terminated.

A summary of activity under the 2008 Plan, 2015 Plan and 2018 Plan and related information is as follows:

 

           Options Outstanding  
     Shares
Available
for Grant
    Number
of Shares
Outstanding
    Weighted-
Average
Exercise
Price Per
Share
     Weighted-
Average
Remaining
Contractual
Term
(Years)
     Aggregate
Intrinsic
Value of
Outstanding
Options
(in thousands)
 

Outstanding — December 31, 2017

     1,503,770       7,470,601     $ 3.09        8.12      $ 12,363  

Awards authorized under the 2015 Plan

     2,095,808            

Awards authorized under the 2018 Plan

     1,500,000            

Options granted

     (3,486,150     3,486,150       2.37        

Options exercised

     —         (118,942     1.50        

Options forfeited/cancelled

     118,072       (118,072     4.31        
  

 

 

   

 

 

         

Outstanding — September 30, 2018

     1,731,500       10,719,737     $ 2.86        8.06      $ 1,420  
  

 

 

   

 

 

         

Exercisable — September 30, 2018

       5,376,902     $ 3.07        7.19      $ 1,251  
    

 

 

         

Vested and expected to vest — September 30, 2018

       10,719,737     $ 2.86        8.06      $ 1,420  
    

 

 

         

The weighted-average grant date fair values of options granted during the three and nine months ended September 30, 2018 was $1.56 and $1.76 per share, and $1.01 and $1.07 per share during the three and nine months ended September 30, 2017. The aggregate intrinsic value of options exercised was $21,000 and $0.2 million for the three and nine months ended September 30, 2018, and $0 and $0.1 million for the three and nine months ended September 30, 2017. The total grant date fair value of options vested for the three and nine months ended September 30, 2018 was $1.5 million and $4.6 million, and $1.4 million and $5.1 million during the three and nine months ended September 30, 2017.

As of September 30, 2018, total unrecognized stock-based compensation related to unvested stock options was $10.1 million. These costs are expected to be recognized over a remaining weighted-average period of 2.1 years as of September 30, 2018.

2015 Employee Stock Purchase Plan

The Company adopted the 2015 Employee Stock Purchase Plan (ESPP) and initially reserved 700,000 shares of common stock as of its effective date of July 15, 2015. The number of shares initially reserved for issuance under the ESPP will increase automatically on January 1 for nine years from the first offering date by the number of shares equal to 1% of the total outstanding shares of the Company’s common stock as of the immediately preceding December 31. The aggregate number of shares issued over the term of the 2015 Employee Stock Purchase Plan will not exceed 3,400,000 shares of common stock.

Under the ESPP, participants are offered the option to purchase shares of the Company’s common stock at a 15% discount during a series of discrete offering periods, subject to any plan limitations. The ESPP will not become effective until such time as the Compensation Committee determines in the future, and as of September 30, 2018, the initial offering periods had not commenced. As of September 30, 2018, no shares of common stock have been issued to employees participating in the ESPP and 700,000 shares were available for issuance under the ESPP.

 

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Table of Contents

10. Income Taxes

The Company did not record a provision for U.S. federal income taxes for the three and nine months ended September 30, 2018 because it expects to generate a loss for the year ended December 31, 2018. The net income tax benefit of $5,000 and $0.4 million for the three and nine months ended September 30, 2018 primarily represented income tax benefit resulting from foreign research and development tax credits. Income tax expense of $37,000 and $0.1 million for the three and nine months ended September 30, 2017 represented foreign taxes. The Company’s net U.S. deferred tax assets continue to be offset by a full valuation allowance.

On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (Tax Act). The Tax Act significantly revises U.S. tax law by, among other provisions, lowering the U.S. federal statutory income tax rate from 35% to 21%, changing rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017 and eliminating or reducing certain income tax deductions.

The effects of changes in tax laws are required to be recognized in the period in which the legislation is enacted. However, due to the complexity and significance of the Tax Act’s provisions, the FASB issued ASU No. 2018-06, Income Taxes (Topic 740) pursuant to the SEC staff issued Staff Accounting Bulletin No. 118 (SAB 118), which allows companies to record the tax effects of the Tax Act on a provisional basis based on a reasonable estimate, and then, if necessary, subsequently adjust such amounts during a limited measurement period as more information becomes available. The measurement period ends when a company has obtained, prepared, and analyzed the information necessary to finalize its accounting, but cannot extend beyond one year from enactment.

In connection with the Company’s initial analysis of the Tax Act, it recorded a decrease of its net deferred tax assets of $7.2 million for the period ended December 31, 2017, to account for the rate reduction. This did not have an impact on the Company’s condensed consolidated financial statements since its U.S. deferred tax assets are fully offset by a valuation allowance. The Company finalized the analysis during the three months ended September 30, 2018, with no material changes to the initial estimated decrease of its net deferred tax assets, and the accounting is now complete.

11. Restructuring Costs

In June 2016, the Company halted investment in PNT2258 and closed the related Phase 2 clinical trials to further enrollment. As a result, the Company closed its research facility in Plymouth, Michigan, renegotiated and terminated certain contracts, and implemented staff reductions in the United States and Canada.

The following table summarizes restructuring activities for the three months ended September 30, 2018 and 2017:

 

     Three Months Ended September 30,  
     2018      2017  
     (in thousands)  

Beginning balance

   $ 86      $ 206  

Adjustments to research and development expense

     (10      (38

Cash payments

     (5      (58
  

 

 

    

 

 

 

Ending balance

   $ 71      $ 110  
  

 

 

    

 

 

 

The following table summarizes restructuring activities for the nine months ended September 30, 2018 and 2017:

 

     Nine Months Ended September 30,  
     2018      2017  
     (in thousands)  

Beginning balance

   $ 137      $ 763  

Adjustments to research and development expense

     (10      (112

Cash payments

     (56      (541
  

 

 

    

 

 

 

Ending balance

   $ 71      $ 110  
  

 

 

    

 

 

 

The accrual balance is currently expected to be substantially paid by the end of 2018.

 

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ITEM 2.

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

The following discussion contains management’s discussion and analysis of our financial condition and results of operations and should be read together with the unaudited condensed consolidated financial statements and the notes thereto included in Part I, Item 1 of this quarterly report and with our audited consolidated financial statements and related notes thereto for the year ended December 31, 2017, included in our Annual Report on Form 10-K. This discussion and other parts of this quarterly report contain forward-looking statements that involve risks and uncertainties, such as our plans, objectives, expectations, intentions and beliefs. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section entitled “Risk Factors” included elsewhere is this report.

Overview

We are a clinical stage drug development company advancing targeted therapeutics for the treatment of patients with unmet medical needs in hematology and oncology. We have a highly experienced management team with a proven track record of success in oncology drug development. We are an ambitious company, oriented towards achieving the successful registration and commercialization of our product candidates.

During the third quarter of 2018, we acquired from Gilead Sciences, Inc. (Gilead) our lead product candidate momelotinib, a potent, selective and orally-bioavailable JAK1, JAK2 and ACVR1 inhibitor. Momelotinib has been investigated in two completed Phase 3 trials for the treatment of myelofibrosis and has demonstrated a potentially differentiated therapeutic profile encompassing anemia-related benefits, as well as achieving substantive spleen and constitutional symptom control. We are currently preparing for discussions with regulators to determine the registration path for momelotinib and anticipate reporting next steps in the first half of 2019.

We are also advancing SRA737, our potent, highly selective, orally bioavailable small molecule inhibitor of Checkpoint kinase 1 (Chk1). Chk1 is a key regulator of cell cycle progression and the DDR replication stress response. In cancer cells, intrinsic replication stress is induced by factors such as oncogenes (e.g., CCNE1 or MYC ), genetic mutations in DNA repair machinery (e.g., BRCA1 or FANCA ), genetic mutations leading to a dysregulated cell cycle (e.g., TP53 or RAD50 ) or other genomic alterations. This replication stress results in persistent DNA damage and genomic instability leading to an increased dependency on Chk1 for survival. Targeted inhibition of Chk1 by SRA737 may therefore be synthetically lethal to cancer cells with elevated intrinsic replication stress and have utility as a monotherapy in a range of tumor indications. The combination of SRA737 with other modalities, such as other agents that target the DDR network and certain chemotherapeutics, may also provide synergistic anti-tumor activity via a variety of potential biological mechanisms. Importantly, the oral bioavailability of SRA737 may afford greater dosing flexibility for both monotherapy and combination therapy settings than is possible with intravenously administered agents.

We are pursuing an innovative development plan for SRA737, which is currently being evaluated in two Phase 1/2 clinical trials in patients with advanced cancer. Our SRA737-01 trial is intended to evaluate SRA737’s potential to induce synthetic lethality as monotherapy, while the SRA737-02 trial is intended to evaluate the combination of SRA737 potentiated by subtherapeutic, low-dose gemcitabine.

During the second quarter of 2018, we further refined our SRA 737-01 monotherapy study to focus on high grade serous ovarian cancer (HGSOC), supported by emerging data in the field that provides clinical validation for Chk1 inhibition in this indication. Accordingly, we are prioritizing the enrollment of genetically defined HGSOC patients into this trial, while continuing to enroll patients into the trial’s other indications, although with lower priority.

For the SRA737-02 Phase 1/2 Low-Dose Gemcitabine Combination trial, during the second quarter of 2018, we commenced the Cohort Expansion Phase 2 portion of this trial, which is enrolling patients across four indications. We are also in the process of modifying this study to add and prioritize enrollment for a cohort of genetically defined HGSOC patients, replacing an originally proposed cohort of urothelial cancer patients.

We expect to report preliminary data from both trials in the first half of 2019.

Concurrently, we are designing clinical trials and conducting preclinical research evaluating SRA737 in combination with other DDR-targeted agents, including poly ADP-ribose polymerase (PARP) inhibitors, as well as with immuno-oncology therapeutics, that will guide the next planned wave of clinical development for our asset, potentially further broadening its therapeutic utility. In the first quarter of 2018, we announced an agreement with Janssen Research & Development, LLC (Janssen), under which they have agreed to supply us with TESARO’s ZEJULA ® (niraparib), facilitating the planned initiation of a PARP inhibitor combination trial with SRA737 for the treatment of prostate cancer. We are currently evaluating the optimal timing to commence this trial within the context of our recently expanded portfolio.

 

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Our pipeline also includes SRA141, a potent, selective, orally bioavailable small molecule inhibitor of cell division cycle 7 kinase (Cdc7). Cdc7 is a key regulator of DNA replication and is involved in the DDR network, making it a compelling emerging target for the potential treatment of a broad range of tumor types. During the third quarter of 2018, we successfully completed the Investigational New Drug Application (IND) filing process with the U.S. Food and Drug Administration (FDA) for SRA141 and we are planning for a Phase 1/2 trial with this drug candidate in patients with colorectal cancer. Upon dosing of the first patient in the first Phase 1 clinical trial of SRA141, a milestone payment of $4.0 million will be due to Carna Biosciences, Inc. (Carna), the licensor of this asset. We are currently evaluating the optimal timing to commence this trial within the context of our recently expanded portfolio.

We retain the global commercialization rights to momelotinib, SRA737 and SRA141.

Since inception, we have devoted substantially all of our resources to research and development activities, including the clinical development of our current product candidates momelotinib, SRA737, SRA141 and our former product candidate PNT2258, and providing general and administrative support for these operations. We have never generated revenue and have incurred significant net losses since inception. Our net losses were $15.6 million and $39.1 million for the three and nine months ended September 30, 2018 and $10.0 million and $31.4 million for the three and nine months ended September 30, 2017. As of September 30, 2018, we had an accumulated deficit of $663.1 million. We expect to incur significant expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses will increase substantially as we:

 

   

invest to further develop our product candidates, momelotinib, a small molecule inhibitor targeting JAK1, JAK2 and ACVR1; SRA737, a small molecule inhibitor targeting Chk1; and SRA141, a small molecule inhibitor targeting Cdc7;

 

   

achieve development milestones that trigger payments due under certain agreements, including a milestone payment of $5.0 million that would be due to Gilead upon the dosing of the first patient in a registrational clinical trial for momelotinib and a milestone payment of $4.0 million that would be due to Carna upon dosing of the first patient in the first Phase 1 clinical trial for SRA141;

 

   

acquire or in-license additional product candidates and technologies;

 

   

develop additional product candidates;

 

   

hire additional clinical, scientific, drug development and management personnel, as well as personnel to support any future commercialization efforts;

 

   

invest in scaling our manufacturing capacity to support development and our global commercialization strategy;

 

   

seek regulatory and marketing approvals for any product candidates that we may develop;

 

   

ultimately establish a sales, marketing and distribution infrastructure to commercialize any drugs for which we may obtain marketing approval;

 

   

defend against and resolve lawsuits or other legal issues;

 

   

maintain, expand and protect our intellectual property portfolio; and

 

   

add operational, financial and management information systems and personnel to continue to operate as a public company.

We have funded our operations to date primarily from the issuance and sale of our common stock through public offerings, and our convertible and redeemable convertible preferred stock in private financings and, to a lesser extent, through debt financings and exercises of our preferred stock warrants. As of September 30, 2018, we had cash and cash equivalents of $116.1 million.

Components of Statements of Operations

Operating Expenses

Research and Development

Research and development expenses consist primarily of the following:

 

   

fees or milestone payments incurred in connection with license and asset purchase agreements;

 

   

personnel-related costs, which include salaries, benefits, stock-based compensation, recruitment fees and travel costs;

 

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costs associated with research and preclinical studies, clinical trials, regulatory activities and manufacturing activities to support clinical activities;

 

   

fees paid to external service providers that conduct certain research and development, clinical and manufacturing activities on our behalf; and

 

   

facility-related costs, which include direct and allocated expenses for rent and maintenance of facilities, depreciation and amortization expenses and other supplies.

The largest recurring component of our total operating expenses has historically been our investment in research and development activities, including the clinical development of our product candidates SRA737 and SRA141. We expect our research and development expenses will increase over the next few years as we advance our development programs, including our recently acquired product candidate momelotinib, achieve development milestones that trigger payments due under certain agreements, pursue regulatory approval of our product candidates in the United States and other jurisdictions, expand our portfolio of product candidates and prepare for potential commercialization, which will require a significant investment in areas related to contract manufacturing and inventory buildup.

The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for momelotinib, SRA737, SRA141 or any future product candidates. The probability of success of our product candidates may be affected by numerous factors, including clinical data, regulatory developments, competition, manufacturing capability and commercial viability. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization of momelotinib, SRA737, SRA141 or any future product candidates.

General and Administrative

General and administrative expenses consist of personnel-related costs, facility-related costs, allocated expenses and professional fees for services, including legal, patent prosecution and maintenance, human resources, audit and accounting services. Personnel-related costs consist of salaries, benefits, stock-based compensation, recruitment fees, severance costs and travel costs.

We expect to incur additional expenses associated with supporting our growing research and development activities, operating as a public company and other administration and professional services.

Other Income, net

Other income primarily consists of (i) interest and dividends earned on our cash and cash equivalents, (ii) interest expense associated with our term loan and non-cash interest costs associated with the amortization of the debt discount and final payment fee, and (iii) foreign currency exchange gains and losses related to transactions and monetary asset and liability balances denominated in currencies other than the U.S. dollar. Foreign currency exchange gains and losses may also fluctuate in the future due to changes in foreign currency exchange rates.

Provision for (Benefit from) Income Taxes, net

Provision for (benefit from) income taxes, net consists of federal and state income taxes in the United States, income tax benefit resulting from research and development tax credits in Canada, income taxes in Canada and Australia, as well as deferred income taxes reflecting the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and changes in related valuation allowance.

We did not record a provision for U.S. federal income taxes for the three and nine months ended September 30, 2018 because we expect to generate a loss for the year ended December 31, 2018. Our tax benefit relates to research and development tax credits in Canada and our income tax provision relates to income taxes in Canada and Australia. Our net U.S. deferred tax assets continue to be offset by a full valuation allowance.

On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (Tax Act). The Tax Act significantly revises U.S. tax law by, among other provisions, lowering the U.S. federal statutory income tax rate from 35% to 21%, changing rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017 and eliminating or reducing certain income tax deductions.

 

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The effects of changes in tax laws are required to be recognized in the period in which the legislation is enacted. However, due to the complexity and significance of the Tax Act’s provisions, the Financial Accounting Standards Board (FASB) issued FASB Accounting Standards Update (ASU) No. 2018-06, Income Taxes (Topic 740) pursuant to the SEC staff issued Staff Accounting Bulletin No. 118 (SAB 118), which allows companies to record the tax effects of the Tax Act on a provisional basis based on a reasonable estimate, and then, if necessary, subsequently adjust such amounts during a limited measurement period as more information becomes available. The measurement period ends when a company has obtained, prepared, and analyzed the information necessary to finalize its accounting, but cannot extend beyond one year from enactment.

In connection with our initial analysis of the Tax Act, we recorded a decrease to our net deferred tax assets of $7.2 million for the period ended December 31, 2017, to account for the rate reduction. This did not have an impact on the condensed consolidated financial statements since our U.S. deferred tax assets are fully offset by a valuation allowance. We finalized the analysis during the three months ended September 30, 2018, with no material changes to the initial estimated decrease to our net deferred tax assets.

Results of Operations

Three Months Ended September 30, 2018 Compared to Three Months Ended September 30, 2017

 

     Three Months Ended
September 30,
     Change
$
 
     2018      2017  
     (in thousands)  

Operating expenses:

  

Research and development

   $ 12,913      $ 7,405      $ 5,508  

General and administrative

     3,138        2,778        360  
  

 

 

    

 

 

    

 

 

 

Total operating expenses

     16,051        10,183        5,868  
  

 

 

    

 

 

    

 

 

 

Loss from operations

     (16,051      (10,183      (5,868

Other income, net

     479        225        254  
  

 

 

    

 

 

    

 

 

 

Loss before provision for (benefit from) income taxes, net

     (15,572      (9,958      (5,614

Provision for (benefit from) income taxes, net

     (5      37        (42
  

 

 

    

 

 

    

 

 

 

Net loss

   $ (15,567    $ (9,995    $ (5,572
  

 

 

    

 

 

    

 

 

 

Research and Development

Research and development expenses increased $5.5 million, from $7.4 million for the three months ended September 30, 2017, to $12.9 million for the three months ended September 30, 2018. The increase was primarily due to a $3.0 million upfront fee paid to Gilead to acquire our lead product candidate momelotinib, an increase of $2.0 million in clinical trial costs and a $0.7 million increase in personnel-related and overhead costs for the three months ended September 30, 2018. These increased costs were partially offset by a $0.2 million decrease in research and preclinical costs related to SRA737 and SRA141 for the three months ended September 30, 2018.

General and Administrative

General and administrative expenses increased $0.4 million, from $2.8 million for the three months ended September 30, 2017 to $3.1 million for the three months ended September 30, 2018. The increase was primarily attributable to an increase in personnel-related costs, professional fees and allocated overhead for the three months ended September 30, 2018.

Other Income, net

Other income, net increased $0.3 million, from $0.2 million for the three months ended September 30, 2017 to $0.5 million for the three months ended September 30, 2018. The increase was primarily attributable to an increase in interest income as a result of higher balances of cash and cash equivalents and rising interest rates for the three months ended September 30, 2018.

Provision for (benefit from) income taxes, net

Net benefit from income taxes was $5,000 for the three months ended September 30, 2018, compared to provision for income taxes of $37,000 for the three months ended September 30, 2017.

 

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Nine Months Ended September 30, 2018 Compared to Nine Months Ended September 30, 2017

 

     Nine Months Ended
September 30,
     Change
$
 
     2018      2017  
     (in thousands)  

Operating expenses:

  

Research and development

   $ 30,032      $ 22,607      $ 7,425  

General and administrative

     10,736        9,207        1,529  
  

 

 

    

 

 

    

 

 

 

Total operating expenses

     40,768        31,814        8,954  
  

 

 

    

 

 

    

 

 

 

Loss from operations

     (40,768      (31,814      (8,954

Other income, net

     1,333        506        827  
  

 

 

    

 

 

    

 

 

 

Loss before provision for (benefit from) income taxes, net

     (39,435      (31,308      (8,127

Provision for (benefit from) income taxes, net

     (383      108        (491
  

 

 

    

 

 

    

 

 

 

Net loss

   $ (39,052    $ (31,416    $ (7,636
  

 

 

    

 

 

    

 

 

 

Research and Development

Research and development expenses increased $7.4 million, from $22.6 million for the nine months ended September 30, 2017, to $30.0 million for the nine months ended September 30, 2018. The increase was primarily due to a $3.0 million upfront fee paid to Gilead to acquire our lead product candidate, momelotinib, a $5.4 million increase in clinical trial costs and a $1.4 million increase in personnel-related costs for the nine months ended September 30, 2018. These increased costs were partially offset by a $1.5 million decrease in third-party manufacturing costs related to SRA737 and SRA141 and a $0.9 million decrease in research, preclinical and other support costs for the nine months ended September 30, 2018.

General and Administrative

General and administrative expenses increased $1.5 million, from $9.2 million for the nine months ended September 30, 2017 to $10.7 million for the nine months ended September 30, 2018. The increase was attributable to a $1.3 million increase in personnel-related costs, professional fees and allocated overhead and a $0.2 million increase in business development costs for the nine months ended September 30, 2018.

Other Income, net

Other income, net increased $0.8 million, from $0.5 million for the nine months ended September 30, 2017 to $1.3 million for the nine months ended September 30, 2018. The increase was primarily attributable to an increase in interest income as a result of higher cash balances of cash and cash equivalents and rising interest rates for the nine months ended September 30, 2018.

Provision for (benefit from) income taxes, net

Net benefit from income taxes was $0.4 million for the nine months ended September 30, 2018, compared to provision for income taxes of $0.1 million for the nine months ended September 30, 2017. The net benefit from income taxes for the nine months ended September 30, 2018 primarily represented benefit from foreign research and development tax credits.

Liquidity and Capital Resources

Capital Resources

Since our inception, we have never generated revenue and have incurred significant net losses. Our net losses for the three and nine months ended September 30, 2018 were $15.6 million and $39.1 million and for the three and nine months ended September 30, 2017 were $10.0 million and $31.4 million. As of September 30, 2018, we had an accumulated deficit of $663.1 million. Our principal sources of liquidity as of September 30, 2018 were cash and cash equivalents of $116.1 million.

On March 6, 2018, we completed an underwritten public offering of an aggregate of 21,850,000 shares of common stock at a price to the public of $2.25 per share. The aggregate net proceeds received by us from the offering were $46.0 million, net of underwriting discounts and commissions and offering expenses of $3.2 million.

 

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On August 21, 2018, we entered into a Loan and Security Agreement (Loan Agreement) with Silicon Valley Bank (SVB), pursuant to which we may obtain a loan of aggregate principal amount of up to $15.0 million. As of September 30, 2018, we borrowed $5.0 million under the first tranche, which bears interest at the greater of 6.0% or a floating per annum rate 1.0% above the prime rate (for an interest rate of 6.25% at September 30, 2018) and matures on August 1, 2022.

We expect to incur significant expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses will increase substantially as we:

 

   

invest to further develop our product candidates, momelotinib, a small molecule inhibitor targeting JAK1, JAK2 and ACVR1; SRA737, a small molecule inhibitor of Chk1; and SRA141, a small molecule inhibitor targeting Cdc7;

 

   

achieve development milestones that trigger payments due under certain agreements, including a milestone payment of $5.0 million that would be due to Gilead upon the dosing of the first patient in a registrational clinical trial for momelotinib and a milestone payment of $4.0 million that would be due to Carna upon dosing of the first patient in the first Phase 1 clinical trial for SRA141;

 

   

acquire or in-license additional product candidates and technologies;

 

   

develop additional product candidates;

 

   

hire additional clinical, scientific, drug development and management personnel, as well as personnel to support any future commercialization efforts;

 

   

invest in scaling our manufacturing capacity to support development and our global commercialization strategy;

 

   

seek regulatory and marketing approvals for any product candidates that we may develop;

 

   

ultimately establish a sales, marketing and distribution infrastructure to commercialize any drugs for which we may obtain marketing approval;

 

   

defend against and resolve lawsuits or other legal issues;

 

   

maintain, expand and protect our intellectual property portfolio; and

 

   

add operational, financial and management information systems and personnel to continue to operate as a public company.

To fund our current operating plans, we will need to raise additional capital. Our existing cash and cash equivalents will not be sufficient for us to complete development of our product candidates and, if applicable, to prepare for commercializing any product candidate that may receive approval. Accordingly, we will continue to require substantial additional capital to continue our clinical development and potential commercialization activities; however, we believe that our existing cash and cash equivalents will be sufficient to fund our current operating plans through at least the next twelve months. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities. However, our forecast for the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our preclinical and clinical development efforts.

We plan to continue to fund our current operating plans’ needs through equity financings or other arrangements. To the extent that we raise additional capital through future equity financings, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through the issuance of debt securities, these securities could contain covenants that would restrict our operations. There can be no assurance that such additional financing, if available, can be obtained on terms acceptable to us. If we are unable to obtain such additional financing, we would need to reevaluate our future operating plans.

 

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Cash Flows

The following table summarizes our cash flows for the periods indicated:

 

     Nine Months Ended
September 30,
 
     2018      2017  
     (in thousands)  

Cash used in operating activities

   $ (35,142    $ (28,555

Cash used in investing activities

     (59      (92

Cash provided by financing activities

     51,129        27,445  

Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash

     (36      6  
  

 

 

    

 

 

 

Net increase (decrease) in cash, cash equivalents and restricted cash

   $ 15,892      $ (1,196
  

 

 

    

 

 

 

Cash Flows from Operating Activities

For the nine months ended September 30, 2018, cash used in operating activities of $35.1 million was attributable to a net loss of $39.1 million, partially offset by $5.0 million in non-cash charges and a net change of $1.1 million in our net operating assets and liabilities. The non-cash charges consisted primarily of $5.1 million in stock-based compensation. The change in net operating assets and liabilities was primarily attributable to an increase in prepaid expenses and other assets of $1.8 million and a decrease in accounts payable of $0.4 million, partially offset by an increase in accrued liabilities of $1.1 million.

For the nine months ended September 30, 2017, cash used in operating activities of $28.6 million was attributable to a net loss of $31.4 million, partially offset by $4.8 million in non-cash charges and a net change of $1.9 million in our net operating assets and liabilities. The non-cash charges consisted primarily of $4.5 million in stock-based compensation. The change in net operating assets and liabilities was primarily attributable to a $2.0 million payment to CRT Pioneer Fund (CPF) pursuant to our license agreement with CPF upon the successful transfer of the SRA737 clinical trials to us.

Cash Flows from Investing Activities

For the nine months ended September 30, 2018 and 2017, cash used in investing activities was primarily attributable to the purchase of property and equipment.

Cash Flows from Financing Activities

For the nine months ended September 30, 2018 and 2017, cash provided by financing activities of $51.1 million and $27.4 million, respectively, was primarily attributable to net proceeds received from the sale and issuance of our common stock upon our follow-on offerings. For the nine months ended September 30, 2018, cash provided by financing activities also included borrowing under the Loan Agreement of $5.0 million.

Contractual Obligations and Commitments

In August 2018, we entered into a Loan Agreement with SVB, pursuant to which we may obtain a loan of aggregate principal amount of up to $15.0 million. As of September 30, 2018, we borrowed $5.0 million under the first tranche. Estimated principal payments (excluding interest and final payment fee) under the Loan Agreement as of September 30, 2018 are $3.2 million within 1 to 3 years and $1.8 million within 3 to 5 years.

Off-Balance Sheet Arrangements

We do not currently engage in off-balance sheet financing arrangements. In addition, we do not have any interest in entities referred to as variable interest entities, which includes special purpose entities and other structure finance entities.

 

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Critical Accounting Policies and Estimates

Our condensed consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles (GAAP). The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and related disclosures. These estimates form the basis for judgments we make about the carrying values of our assets and liabilities, which are not readily apparent from other sources. We base our estimates and judgments on historical experience and on various other assumptions that we believe are reasonable under the circumstances. On an ongoing basis, we evaluate our estimates and assumptions. Our actual results may differ from these estimates under different assumptions or conditions.

We believe that the assumptions and estimates associated with research and development expenses and stock-based compensation have the most significant impact on our condensed consolidated financial statements. Therefore, we consider these to be our critical accounting policies and estimates.

There have been no significant changes in our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in Management’s Discussion and Analysis of Financial Condition and Operations included in our Annual Report on Form 10-K for the year ended December 31, 2017.

 

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are exposed to market risks in the ordinary course of our business. These risks primarily include interest rate sensitivities and foreign currency risk.

Interest Rate Sensitivity

We had cash and cash equivalents of $116.1 million as of September 30, 2018, which consisted primarily of bank deposits and money market funds. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates. However, because of the short-term nature of the instruments in our portfolio, a sudden change in market interest rates would not be expected to have a material impact on our condensed consolidated financial condition or results of operations. We do not believe that our cash or cash equivalents have significant risk of default or illiquidity.

In addition, we had an outstanding balance of $5.0 million under our Loan Agreement as of September 30, 2018. Borrowings under the Loan Agreement bear interest at the greater of 6% or a floating per annum rate of 1.0% above the prime rate (for an interest rate of 6.25% at September 30, 2018). The effect of a hypothetical 10% change in interest rates would not have a material impact on our operating loss.

Foreign Currency Risk

Our condensed consolidated results of operations and cash flows are subject to fluctuations due to changes in foreign currency exchange rates. A substantial majority of our expenses are denominated in U.S. Dollars, with the remainder in Canadian Dollars, British Pounds and Australian Dollars. Our condensed consolidated results of operations and cash flow are, therefore, subject to fluctuations due to changes in foreign currency exchange rates and may be adversely affected in the future due to changes in foreign exchange rates. To date, we have not entered into any hedging arrangements with respect to foreign currency risk or other derivative instruments. The effect of a hypothetical 10% change in foreign currency exchanges rates applicable to our business would not have a material impact on our operating loss.

 

ITEM 4.

CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, have performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as amended) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of September 30, 2018 to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely discussion regarding required disclosures.

Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

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Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended September 30, 2018 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II

 

ITEM 1.

LEGAL PROCEEDINGS

On November 9, 2016, a purported securities class action lawsuit was filed in the United States District Court for the Southern District of New York against us and certain of our executive officers (the New York Lawsuit). The New York Lawsuit was brought by purported stockholders of our company seeking to represent a class consisting of stockholders who purchased stock between July 15, 2015 and June 6, 2016. The New York Lawsuit asserts claims under Sections 10(b) and 20(a) of the Exchange Act and seeks unspecified damages and other relief. On March 13, 2018, the United States District Court for the Southern District of New York granted the defendants’ motion to dismiss and entered a final judgment dismissing the New York Lawsuit with prejudice. Plaintiffs have filed an appeal. We believe that the claims in the New York Lawsuit are without merit and intend to defend the lawsuit vigorously. Due to the early stage of the litigation, we are unable to predict the outcome of this matter. However, at this point in time, we do not expect the outcome of these claims will have a material impact on our condensed consolidated financial statements.

On November 18, 2016, a purported securities class action lawsuit was filed in the Superior Court of the State of California for the County of San Mateo against us, certain of our executive officers and directors, and the underwriters for our initial public offering of our common stock. On February 9, 2017, a substantially identical putative class action suit was filed in the Superior Court of the State of California for the County of San Mateo asserting the same claims on behalf of the same putative class (the two California lawsuits together, the California Lawsuits). The California Lawsuits were brought by purported stockholders of our company seeking to represent a class consisting of stockholders who purchased stock pursuant to and/or traceable to our Registration Statement on Form S-1. The lawsuits assert claims under Sections 11 and 15 of the Exchange Act and seek unspecified damages and other relief. On August 1, 2018, all parties reached a mutually acceptable resolution to the California Lawsuits by way of a mediated settlement, which is subject to the parties’ execution of final settlement documents and the approval of the court. While we believe that the claims are without merit, we believe settlement will reduce the ultimate cost and distraction of further litigation. We do not expect our portion of the settlement amount to have a material impact on our condensed consolidated financial statements.

From time to time, we may become involved in various other claims and legal proceedings relating to claims arising out of our operations. We are not currently a party to any other legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

 

ITEM 1A.

RISK FACTORS

Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this report, including our consolidated financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding whether to invest in our common stock. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and growth prospects. In such an event, the market price of our common stock could decline, and you may lose all or part of your investment.

Risks Related to Our Business and Industry

We have incurred net losses in every year since our inception and anticipate that we will continue to incur net losses for the foreseeable future.

We are a clinical stage hematology and oncology company with a limited operating history. Since inception, we have incurred significant operating losses. Our net losses were $39.1 million and $42.0 million for the nine months ended September 30, 2018 and the year ended December 31, 2017, respectively. As of September 30, 2018, we had an accumulated deficit of $663.1 million. Investment in hematology and oncology product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval and become commercially viable. For example, in June 2016 we decided to suspend the development of our former lead product candidate PNT2258 after an interim analysis of data from a Phase 2 clinical trial of PNT2258 indicated only modest efficacy. We have no products approved for commercial sale and have not generated any revenue to date, and we continue to incur significant research and development and other expenses related to our ongoing operations. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue the development of our product candidates, momelotinib, SRA737 and SRA141, fund research and preclinical studies and clinical trials, seek to identify additional product candidates, in-license additional products or technologies, seek regulatory approval, prepare for potential commercialization and continue to operate as a public company.

 

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Even if we succeed in commercializing momelotinib, SRA737, SRA141 or any future product candidates we may acquire or develop, we will continue to incur substantial research and development and other expenditures to develop and market these and other product candidates. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital.

Our business is highly dependent on the success of our product candidates, momelotinib, SRA737 and SRA141. If we are unable to successfully develop, obtain regulatory approval for and commercialize momelotinib, SRA737 and SRA141, or experience significant delays in doing so, our business will be materially harmed.

Our business and future success depends on our ability to successfully develop, obtain regulatory approval for and commercialize our product candidates, momelotinib, a Phase 3 product candidate, and SRA737 and SRA141, which are both at earlier stages of development. We recently invested financial resources to acquire momelotinib from Gilead. While momelotinib is a late-stage product candidate for which previous Phase 3 clinical trial data suggest promising safety and efficacy in patients who have an inadequate response to, progression on or are intolerant of ruxolitinib, it will require additional clinical testing, including at least one additional adequate and well-controlled Phase 3 clinical trial, before we can seek regulatory approval and begin commercialization, if it all. We have also invested effort and financial resources in the research and development of SRA737 and SRA141, and both SRA737 and SRA141 will require significant additional preclinical and clinical testing before we can seek regulatory approval and potentially generate any commercial sales, if at all. Before we can generate any revenue from sales of momelotinib, SRA737, SRA141, or any other product candidate, we must complete additional development activities, submit INDs or foreign equivalents, as well as marketing applications such as New Drug Applications (NDAs) or foreign equivalents, for regulatory review and approval in multiple jurisdictions, make substantial investments, obtain access to sufficient commercial manufacturing capacity and engage in significant marketing and commercial access efforts.

We cannot commercialize product candidates in the United States without first obtaining regulatory approval for the product candidates from the FDA. Similarly, we cannot commercialize product candidates outside of the United States without obtaining regulatory approval from similar regulatory authorities outside of the United States, such as the European Medicines Agency (EMA) in Europe and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. Even if momelotinib, SRA737, SRA141 or another product candidate were to be approved by the FDA or foreign regulatory authorities, any approval might contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, or may be subject to burdensome post-approval study or risk management requirements. If we are unable to obtain regulatory approval for momelotinib, SRA737 or SRA141 in one or more jurisdictions, or if any approval contains significant limitations, we may not be able to obtain sufficient funding or generate sufficient revenue to continue the development, marketing or commercialization of momelotinib, SRA737, SRA141 or any other product candidate that we may acquire or develop in the future. If competitive products developed by third parties show significant benefit in the cancer indications in which we are developing our product candidates, any planned supportive or primary registration trials may be delayed, altered, terminated or not initiated and our other product candidates may never receive regulatory approval. Our clinical development programs for our product candidates may also not receive regulatory approval if we have inadequate financial or other resources to advance these product candidates through the clinical trial process. Furthermore, even if we obtain regulatory approval for any of our product candidates, we will still need to develop sales, marketing and commercialization infrastructure, or collaborate with a third party for the commercialization of our product candidates, establish commercially viable pricing and obtain approval for coverage and adequate reimbursement from third parties, including government payors. If we are unable to successfully commercialize any of our product candidates, we may not be able to generate sufficient revenues to continue our business.

If we are unable to successfully develop and commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.

We will be required to demonstrate, to the satisfaction of regulatory authorities, through clinical trials that our product candidates are safe and effective for use in their target indications before we can obtain regulatory approval for their marketing and commercial sale.

We recently acquired from Gilead our lead product candidate momelotinib, a potent, selective and orally-bioavailable JAK1, JAK2 and ACVR1 inhibitor. Momelotinib has been investigated in two completed Phase 3 trials for the treatment of myelofibrosis and has demonstrated a potentially differentiated therapeutic profile encompassing anemia-related benefits, as well as achieving substantive spleen and constitutional symptom control. We are currently preparing for discussions with regulators to determine the approval path forward for momelotinib and anticipate reporting next steps in the first half of 2019.

 

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Pursuant to Clinical Trial Authorizations (CTAs) granted by the MHRA in the United Kingdom for SRA737, two Phase 1 trials were initiated in the United Kingdom which were transferred to us in January 2017, both of which have been amended to Phase 1/2 trials. We plan to continue our SRA737 development efforts by continuing these clinical trials, including through potential expansion into other countries, and potentially conducting additional preclinical and clinical studies to further our understanding of SRA737.

SRA141 has never been evaluated in a clinical trial. We recently successfully completed the IND filing process with the FDA for SRA141 and we are planning for a Phase 1/2 trial with this drug candidate in patients with colorectal cancer.

The success of our product candidates and any future product candidates that we may acquire or develop will depend on many factors, including, but not limited to, the following:

 

   

successful completion of preclinical studies;

 

   

successful translation of preclinical results in human clinical trials;

 

   

successful enrollment in, and completion of, clinical trials that produce data which adequately demonstrate the product candidate’s benefit and risk profile;

 

   

successful transfer of existing trials;

 

   

receipt of marketing approvals from applicable regulatory authorities;

 

   

establishment of clinical trial material and commercial manufacturing capabilities, or arrangements with third-party manufacturers and suppliers on commercially reasonable terms;

 

   

effective patent and trade secret protection and regulatory exclusivity;

 

   

establishment of a commercial sales team, if and when approved, whether alone or in collaboration with others;

 

   

acceptance, if and when approved, by patients, the medical community and third-party payors;

 

   

coverage and adequate reimbursement by third-party payors, including government payors;

 

   

successful competition with other therapies;

 

   

continued acceptable safety profile following approval;

 

   

enforcement and protection of intellectual property rights and claims;

 

   

achievement of desirable medicinal properties for the intended indications; and

 

   

effective growth of an organization of scientists and businesspeople who can develop and commercialize our products, if approved, and technology.

If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully develop and commercialize our product candidates, which would materially harm our business.

If further preclinical development or clinical trials of momelotinib, SRA737, SRA141 or future product candidates that we may develop or acquire fail to demonstrate acceptable safety and efficacy or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of momelotinib, SRA737, SRA141 or future product candidates.

Before obtaining marketing approval from regulatory authorities, including the FDA, for the sale of our product candidates, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans.

The outcome of preclinical testing and early clinical trials may not be predictive of the success of later preclinical testing and clinical trials, and interim results of a clinical trial do not necessarily predict final results. Many companies in the biotechnology industry have suffered significant setbacks in later-stage clinical trials after achieving positive results in early-stage development, and there is a high failure rate for product candidates proceeding through clinical trials. For example, in June 2016, we announced that we decided to suspend the development of our former lead product candidate PNT2258 after an interim analysis of data from a Phase 2 clinical trial of PNT2258 indicated only modest efficacy. We cannot, therefore, guarantee that we will be successful in obtaining the required efficacy and safety profile from momelotinib, SRA737 or SRA141. A failure of one or more preclinical studies or clinical trials can occur at any stage of testing.

We recently acquired from Gilead our lead product candidate momelotinib, a potent, selective and orally-bioavailable JAK1, JAK2 and ACVR1 inhibitor. Momelotinib has been investigated in two completed Phase 3 trials for the treatment of myelofibrosis and has demonstrated a potentially differentiated therapeutic profile encompassing anemia-related benefits, as well as achieving substantive spleen and constitutional symptom control. We are currently preparing for discussions with regulators to determine the approval path forward for momelotinib and anticipate reporting next steps in the first half of 2019. While we believe the safety and efficacy profile of momelotinib in patients who have an inadequate response to, progress on or are intolerant of ruxolitinib appears promising based on the prior Phase 3 trial results, the likely Phase 3 trial we plan to commence in those patients may not be successful. For example, in the SIMPLIFY-1 Phase 3 trial conducted by Gilead in ruxolitinib-naive patients, the key secondary endpoint of total symptom score,

 

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which we might choose to use as the primary endpoint in a potential future Phase 3 trial, was not met. We may also fail to observe meaningful anemia benefits in a potential future Phase 3 trial, which could reduce the potential future value of momelotinib as we believe an anemia benefit could potentially provide a competitive advantage over existing therapies.

We are currently conducting preclinical assessments and two Phase 1/2 clinical trials of SRA737, which we believe will further inform our clinical development plans and patient selection strategies. Both of the current clinical studies for SRA737 are being conducted in the United Kingdom, with one of the clinical studies also being conducted in Spain and currently under consideration for expansion into France. We believe we have completed all necessary preclinical activities to support a potential future IND submission for SRA737 to the FDA. However, we have not yet discussed our plans for any IND submission with the FDA, and if pursued, we may receive feedback from the FDA that delays the submission or clearance of any IND.

SRA141 has never been evaluated in a clinical trial. We recently successfully completed the IND filing process with the FDA for SRA141 and we are planning for a Phase 1/2 trial with this drug candidate in patients with colorectal cancer.

Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and even if the trials are successfully completed, we cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit our product candidates for approval. Many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products. To the extent that the results of our studies and trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, approval of our product candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates.

We may experience numerous unforeseen events during, or as a result of, preclinical studies and clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including, but not limited to:

 

   

undesirable side effects or other unexpected characteristics of our product candidates, causing us or our investigators, regulators or institutional review boards (IRBs) to suspend or terminate the trials;

 

   

regulators or IRBs may not authorize us or our investigators to initiate a clinical trial, conduct a clinical trial at a prospective trial site, or amend a clinical trial;

 

   

government or regulatory delays and changes in regulatory requirements, policy and guidelines;

 

   

delays in reaching or failure to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites and contract research organizations (CROs), or failure by such CROs or trials sites to carry out the clinical trial in accordance with the terms of our agreements with them;

 

   

negative or inconclusive results of preclinical studies or clinical trials;

 

   

decision by us to conduct additional preclinical studies or clinical trials or abandon product development programs;

 

   

a higher number of patients required for clinical trials, slower than expected enrollment, greater than expected competition for patients or higher than expected drop out rates;

 

   

clinical sites electing to terminate their participation in one of our clinical trials, which would likely have a detrimental effect on subject enrollment;

 

   

failure of third-party contractors to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

 

   

inability or unwillingness of patients or medical investigators to follow our clinical trial protocols;

 

   

suspension or termination of clinical trials for various reasons, including unacceptable health risks;

 

   

imposition of a clinical hold for safety reasons or following an inspection of our clinical trial operations or site by the FDA or foreign regulatory authorities;

 

   

greater than expected cost of clinical trials;

 

   

insufficient supply or quality of product candidates or other materials necessary to conduct clinical trials;

 

   

delays or additional costs as a result of the United Kingdom’s decision to leave the European Union and resulting need to decouple the United Kingdom’s regulatory system from that of the European Union; and

 

   

revision of legal or regulatory requirements for approving our product candidates.

 

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If we are required to conduct additional preclinical studies or clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete preclinical studies and clinical trials of our product candidates or other testing, or if the results of these studies, trials or tests do not reflect an acceptable safety or efficacy profile, we may:

 

   

be delayed or unable to submit an IND in the United States, or additional CTAs or equivalents in other countries;

 

   

not have the permission of the FDA or other health authorities to commence clinical trials, or may have a clinical hold placed on one or more of our clinical trials;

 

   

be delayed in obtaining marketing approval;

 

   

not obtain marketing approval at all;

 

   

obtain marketing approval in some countries and not in others;

 

   

obtain approval for indications or patient populations that are not as broad as intended or desired;

 

   

obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;

 

   

be subject to additional post-marketing testing requirements; or

 

   

have the product removed from the market after obtaining marketing approval.

Product development costs will also increase if we experience delays in testing or marketing approvals. We do not know whether any preclinical studies or clinical trials will continue as planned, will need to be restructured or will be completed on schedule, or at all. Significant preclinical studies and clinical trial delays also could allow our competitors to bring products to market before we do and could impair our ability to successfully commercialize our product candidates, any of which may harm our business and results of operations.

Our preclinical and clinical development for SRA737 is focused on the development of targeted therapeutics for genetically-defined cancers, which is a rapidly evolving area of science, and the approach we are taking to develop drugs may not lead to marketable products. It is feasible that genetically-based patient selection strategies might also be employed in our SRA141 development programs.

The discovery and development of targeted therapeutics for genetically-defined cancers, including patients whose tumors harbor the applicable genetic alterations that we believe contribute to cancer, is an emerging field, and the scientific discoveries that form the basis for our efforts to develop genetically-selected product candidates are relatively new. The scientific evidence to support the feasibility of developing product candidates based on these discoveries is both preliminary and limited. Additionally, we may consider approaches such as a basket study in which enrollment is focused on a compilation of different tumor types that share a similar genetic signature. We cannot be sure that regulatory authorities, including the FDA and the EMA, will accept our trial designs or that we will be able to obtain approval for our product candidates.

We are currently developing our SRA737 product candidate for certain genetically-defined subpopulations of the general treated cancer population, and we are now enrolling selected patients into our Monotherapy and Low-Dose Gemcitabine combination studies of SRA737, based on genetic alterations in their tumors or other factors such as histology. In order to obtain marketing approval for SRA737 in the treatment of genetically-defined tumors and cancers, we will need to, among other things, demonstrate to the satisfaction of regulatory authorities that those genetic alterations have predictive clinical utility. We have started to apply our genetic selection criteria to patients in our Monotherapy and our Low-Dose Gemcitabine combination clinical trials, and our approach may change based on our evolving knowledge of the field and on data obtained in our preclinical research and ongoing clinical trials. The goal of our genetic screening is to enroll patients who we believe have the highest probability of responding to the product candidate in order to show compelling evidence of clinical efficacy. Successful identification of patients is dependent on several factors, including, potentially, achieving certainty as to how specific genetic alterations respond to our product candidates and developing companion diagnostics to identify such genetic alterations as appropriate. For example, although we believe, based on scientific and medical literature, and preclinical research, that we have identified certain types and combinations of genetic alterations hypothesized to confer sensitivity to Chk1 inhibition that may be predictive of response to SRA737, we have only recently begun to assess activity of SRA737 in humans and have not discussed the validity of our genetic selection criteria with regulatory authorities, including MHRA, FDA or EMA.

 

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Our genetic selection strategy for SRA737 uses a novel algorithm and is not yet validated as predictive of clinical utility.

In order to obtain marketing approval for SRA737 in patients with genetic alterations hypothesized to confer sensitivity to Chk1 inhibition we will need to, among other things, demonstrate to the satisfaction of regulatory authorities that those genetic alterations have predictive clinical utility. It may be difficult for us to demonstrate the predictive clinical utility of our genetic selection criteria, which select for patients that have various combinations of genetic alterations across multiple gene panels. Although regulatory authorities, including FDA, have approved therapies for use in conjunction with companion diagnostic tests that aid in selecting patients for treatment based on genetic markers, to our knowledge neither the FDA nor the EMA has granted marketing approval for a therapy that requires the use of a companion diagnostic that uses broad gene panel testing to select for patients with various combinations of genetic alterations. The scientific evidence to support the feasibility of developing product candidates based on our selection criteria is both preliminary and limited. We have not discussed the validity of our genetic selection criteria with regulatory authorities, and we cannot be sure that regulatory authorities, including the FDA and EMA, will accept our genetic selection criteria.

Furthermore, we cannot be certain that the patient populations in our trials will be large enough to allow us to successfully determine efficacy of our product candidates, commercialize our product candidates, and achieve profitability. If we are unable to enroll sufficient numbers of patients whose tumors harbor the applicable genetic alterations, or if our product fails to work as we expect, or if we are unable to demonstrate the predictive clinical utility of our genetic selection criteria, our ability to assess and demonstrate the therapeutic effect of our product candidate(s) could be compromised, resulting in longer development times, larger trials, and a greater likelihood of not obtaining regulatory approval for our product candidates. In addition, regulatory authorities may require that we study our product candidates in clinical trials specific for a given tumor (i.e., tissue) type and this may result in increased time and cost. Even if our product candidates demonstrate efficacy in a particular tumor type, we cannot guarantee that any product candidate will behave similarly in multiple or all tumor types, and we may be required to obtain separate regulatory approvals for each tumor type we intend a product candidate to treat. We do not know if our approach will be successful, and if our approach is unsuccessful, our business will suffer.

Failure to successfully validate, develop and obtain regulatory approval for companion diagnostics for SRA737 and our other product candidates could harm our drug development strategy and operational results.

In any pivotal clinical trials of SRA737 we anticipate the potential requirement to screen and identify patients with specific genetic alterations who may derive meaningful benefit, as we have begun to do in our Monotherapy and Low-Dose Gemcitabine combination studies of SRA737. To achieve this, our product development programs for SRA737 and marketing approvals will be dependent on the development and commercialization of a companion diagnostic by us or by third party collaborators. It is feasible that a companion diagnostic might also be required in our SRA141 and other potential development programs.

Companion diagnostics are developed in conjunction with clinical programs for the associated product and are subject to regulation as medical devices by the FDA and comparable regulatory authorities, and, to date, the FDA has required premarket approval of all companion diagnostics for cancer therapies. Generally, when a companion diagnostic is essential to the safe and effective use of a therapeutic product, the FDA requires that the companion diagnostic be approved before or concurrent with approval of the therapeutic product and before a product can be commercialized. The approval of a companion diagnostic as part of the therapeutic product’s labeling limits the use of the therapeutic product to only those patients who express the specific genetic alteration that the companion diagnostic was developed to detect.

If FDA or a comparable regulatory authority requires approval of a companion diagnostic for any of our product candidates, whether before or after the product candidate obtains marketing approval, we, and/or third-party collaborators, may encounter difficulties in developing and obtaining approval for these companion diagnostics. Any delay or failure by us or third-party collaborators to develop or obtain regulatory approval of a companion diagnostic could delay or prevent approval or continued marketing of our related product candidates.

We may also experience delays in developing a sustainable, reproducible and scalable manufacturing process for the companion diagnostic or in transferring that process to commercial partners or negotiating insurance reimbursement plans, all of which may prevent us from completing our clinical trials or commercializing our products on a timely or profitable basis, if at all.

 

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We have acquired or licensed our product candidates from third parties that had already conducted or were in the process of conducting preclinical studies or clinical trials with our product candidates. We may discover that development efforts of third parties, including but not limited to historical studies and trials conducted by third parties, did not comply with all applicable rules and regulations, and we may experience difficulties or delays in assuming responsibility for or completing such ongoing or previously completed clinical development activities. Our acquisition of momelotinib has resulted in us being required to take over responsibility for conducting ongoing momelotinib trials. Further development and commercialization of momelotinib will require significant financial and operational resources from us .

Prior to our acquisition of momelotinib and licensing of SRA737, third parties had been responsible for all development activities for such product candidates, including drug process, preclinical and clinical development activities, submission of CTAs and INDs, development of the trial protocols, establishment and management of clinical and safety databases, submission of a pediatric investigation plan (PIP), and other activities. Although we believe the historical development activities were conducted in accordance with applicable rules and regulations in material respects, we cannot assure you that we will not discover inaccuracies or noncompliance in prior development activities that have an adverse effect on the future development of momelotinib or SRA737. For example, we will need to modify the PIP Gilead agreed to for momelotinib with European Union’s regulatory authorities and conduct the pediatric studies, unless a waiver or deferral is granted, before we can submit a marketing authorization application. Similarly, we will need to submit a pediatric study plan to FDA and conduct the pediatric study, unless a waiver or deferral is granted, prior to submission of an NDA. In addition, a foreign regulatory authority that inspected a SIMPLFY-1 investigational site and CRO concluded that the clinical trial at that site was not conducted in accordance with good clinical practices (GCPs). We do not know what effect, if any, this finding will have on review of any future marketing applications by the FDA or foreign regulatory authorities.

In connection with our acquisition of momelotinib, we assumed the responsibility for all currently ongoing clinical studies with momelotinib following a transition period, including related expenses and manufacturing and regulatory activities, which were previously managed and funded by Gilead. This includes responsibility for the ongoing Phase 3 extended access study, which provides extended access of momelotinib in certain patients enrolled in Gilead sponsored studies, who are currently receiving treatment with momelotinib and have not experienced progression of disease. If we are unable to successfully assume the responsibilities of these trials, if we experience delays in doing so, or if we encounter additional difficulties or delays due to deficiencies in the assumed trials prior to our acquisition of momelotinib, the development of momelotinib may be delayed or suspended. Further, extended access programs provide supportive safety information for regulatory review. Any adverse events or reactions experienced by subjects in the extended access program may be attributed to momelotinib and may limit our ability to obtain regulatory approval with labeling that we consider desirable, or at all.

From time to time we may amend the clinical protocols for our product candidates to include additional objectives that could yield important scientific information critical to our overall development strategy. The protocol amendment process requires review and approval by several review bodies, including regulatory agencies and scientific, regulatory and ethics boards. These protocol amendments may not be accepted by the review bodies in the form submitted, or at all, which may delay our planned enhancements to the clinical development and/or limit or change the type of information we may gather from those studies.

We have received approval from the MHRA for amendments to the SRA737-01 Monotherapy and the SRA737-02 Low-Dose Gemcitabine combination clinical trial protocols. These amendments are designed to enhance the ongoing clinical trials including by expanding the enrollment of patients we predict may be most likely to benefit from SRA737, based on specific genetic alterations in their tumors. These amendments may provide us with the opportunity to more accurately and widely evaluate SRA737’s activity across a number of distinct cancer indications and genetic alterations. If the MHRA, FDA, EMA, an ethics committee or scientific review board, or another regulatory authority objects to or otherwise does not accept or approve any future protocols or protocol amendments or requires us to further modify trial protocols, our related planned clinical development program may be delayed or suspended and/or we may not be able to gather information we think would be useful to advance development of momelotinib, SRA737, SRA141, or other product candidates, and our development programs may be adversely affected.

For example, we are currently pursuing a development program for SRA737 that relies upon a seamless trial design, which presents additional risks compared to traditional three-phase development programs. In a seamless design, an early phase trial assesses clinical activity of a product candidate in a broad range of subjects, and the trial is later expanded to include additional cohorts (for example, including cohorts with entry criteria based in part on the characteristics of the subjects in whom clinical activity was observed during the initial period of the trial, such as genetic markers). The protocol may also be amended with regard to the expansion cohorts to focus, for example, on different treatment endpoints, different doses, or other trial parameters. Through this iterative process, the traditionally distinct Phase 1, Phase 2, and Phase 3 trials are combined into one or more adaptive, or combined-phase, trials.

Whereas the traditional three-phase development program provides for communication with regulatory agencies between each phase, and for the development and review of statistical plans for trials in each phase, a seamless design may require more frequent and fluid communication with regulators to vet the iterative protocol amendments, and new statistical plans may be necessary for each expansion cohort. If we are unable to receive timely or complete feedback to our frequent amendments to protocols and statistical plans from regulatory authorities, our development programs may be delayed and/or we may be required to conduct additional clinical trials.

 

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If we fail to obtain additional capital, we may be unable to acquire additional product candidates and complete the development and commercialization of our product candidates.

We expect to spend substantial capital to acquire additional product candidates and advance momelotinib, SRA737 and SRA141 in preclinical and clinical development, seek regulatory approvals for our product candidates, establish a commercial sales force to market and manufacture products, if any, that are approved for commercial sale. We also incur significant additional compliance and administrative costs as a result of operating as a public company.

Our future capital requirements will depend on many factors, including, but not limited to:

 

   

the progress and results of our planned preclinical studies and clinical trials;

 

   

the scope, progress, results and costs of product candidate discovery, preclinical development, laboratory testing and clinical trials for our future product candidates;

 

   

the costs, timing and outcome of regulatory review of momelotinib, SRA737, SRA141 and any future product candidates;

 

   

the costs of future commercialization activities, including drug sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval, to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of any collaborator;

 

   

the extent to which we acquire or in-license other drugs and technologies;

 

   

our ability to establish and maintain collaborations on favorable terms, if at all;

 

   

the success of any collaborations that we may enter into with third parties;

 

   

the timing and amount of milestone and royalty payments;

 

   

the amount of revenue, if any, received from commercial sales of our product candidates, should any of our drug candidates receive marketing approval; and

 

   

the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims.

Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve drug sales. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of our product candidates, if approved, which we do not expect to be commercially available for many years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives.

We cannot be certain that additional funding will be available on acceptable terms, or at all. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives. We could be required to seek collaborators for our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to our product candidates in markets where we otherwise would seek to pursue development or commercialization ourselves. We also may be unable to acquire additional promising product candidates.

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. The enrollment of patients depends on many factors, including, but not limited to:

 

   

the number and size of clinical trials for other product candidates in the same therapeutic area that are currently in clinical development, and our ability to compete with such trials for patients and clinical trial sites;

 

   

the patient eligibility criteria defined in the protocols;

 

   

the size of the specific patient populations such as those whose tumors harbor the applicable genetic mutations, if required or other defined subsets of a larger patient population;

 

   

the risk that disease progression will result in death or clinical deterioration before the patient can enroll in clinical trials or before sufficient data has been collected such that the patient contributes no meaningful information for the clinical trial in which the patient is enrolled;

 

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the proximity and availability of clinical trial sites for prospective patients;

 

   

the design of the trials;

 

   

our ability to recruit clinical trial investigators with the appropriate competencies and experience;

 

   

our ability to obtain and maintain patient consents; and

 

   

the risk that patients enrolled in clinical trials will drop out of the trials before completion.

Our clinical trials compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates. This competition reduces the number and types of patients and qualified clinical investigators available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors or clinical trial sites may not allow us to conduct our clinical trial at such site if competing trials are already being conducted there. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial site. We may also encounter difficulties finding a clinical trial site at which to conduct our trials. Moreover, because our product candidates are experimental, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy, radiation and other approved therapies, rather than enroll patients in any one of our clinical trials.

Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our planned clinical trials, which could prevent completion of these clinical trials and adversely affect our ability to advance the development of our product candidates or any future product candidates we may develop.

We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates that may later prove to be more profitable or for which there is a greater likelihood of success. In addition, we may intentionally halt or terminate programs in order to conserve capital and focus on our remaining program or programs, which may increase our reliance on those programs to be successful.

Because we have limited financial and managerial resources, we focus our research and development efforts on certain selected product candidates. As a result, we may advertently or inadvertently forgo or delay pursuit of opportunities with other product candidates that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable product candidates. In addition, if we halt or terminate programs in order to conserve capital and focus on our remaining program or programs, it may increase our reliance on the success of such programs and raise our exposure to the risk of failure among any of our programs.

The manufacture of momelotinib, SRA737 and SRA141 requires outsourced, custom manufacturing and we may encounter difficulties in production, particularly with respect to formulation, process development or scaling up of our manufacturing capabilities. If our third-party manufacturers encounter such difficulties, our ability to provide supply of our product candidates for preclinical studies, clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.

As product candidates are developed, it is common that various aspects of the development program, such as manufacturing methods, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives, and any of these changes could cause our product candidates to perform differently and affect the results of planned preclinical studies or future clinical trials.

Currently, SRA737 and SRA141 are manufactured using unoptimized processes by third-party manufacturers, and momelotinib is manufactured using an optimized drug substance process by third-party manufacturers. Although we have secured sufficient quantities of drug substance and drug product to supply our current momelotinib program, starting with the planned potential Phase 3 trial of momelotinib, we will need to obtain additional supplies from third-party manufacturers that we have engaged, or expect to engage. In addition, we may need to develop a pediatric formulation for momelotinib in the future. Although we are working to develop commercially viable manufacturing processes, doing so is a difficult and uncertain task, and there are risks associated with scaling to the level required for advanced clinical trials or commercialization, including, among others, cost overruns, potential problems with process scale up or formulation, process reproducibility, stability issues, lot consistency and timely availability of reagents or raw materials.

Any of these challenges could delay completion of preclinical studies or clinical trials, require bridging studies or trials, or the repetition of one or more studies or trials, increase development costs, delay approval of our product candidates, impair commercialization efforts, increase our cost of goods and have an adverse effect on our business, financial condition, results of operations and growth prospects.

 

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Our reliance on third-party manufacturing partners or suppliers may cause our supply of research and development, preclinical and clinical development materials to become limited or interrupted or fail to be of satisfactory quantity or quality.

We do not have any manufacturing facilities or personnel. We currently rely, and expect to continue to rely, on third parties for the manufacture and supply of preclinical study and clinical trial materials in relation to momelotinib, SRA737 and SRA141, including materials for any combination trials that we may undertake, and any future potential product candidates that we may develop for preclinical and clinical testing, as well as for commercial manufacture if our product candidates receive marketing approval. We have engaged, or expect to engage, third-party manufacturers to obtain materials and consumables necessary for the manufacture of momelotinib, SRA737 and SRA141.

We may be unable to establish further agreements with third-party manufacturers and suppliers or to do so on acceptable terms. Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers and suppliers entails additional risks, including, but not limited to:

 

   

reliance on the third party for sufficient quantity and quality;

 

   

the possible breach of the manufacturing or supply agreement by the third party;

 

   

failure to manufacture or supply the product according to our specifications;

 

   

failure to manufacture or supply the product according to our schedule or at all;

 

   

misappropriation of our proprietary information, including our trade secrets and know-how;

 

   

the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us; and

 

   

reliance on the third party for regulatory compliance, quality assurance and safety reporting.

While we require our third-party manufacturers and suppliers to comply with current good manufacturing practices (cGMPs) in the manufacture of clinical trial materials and commercial supply, should we obtain approval of any product candidates, these third-party manufacturers and suppliers may cease to continue to comply with cGMPs—which are FDA requirements for ensuring product quality control—or similar regulatory requirements outside the United States. Our contract manufacturers and suppliers are subject to continual review and periodic inspections to assess compliance with cGMPs. Accordingly, although we are not involved in the day-to-day operations of our contract manufacturers or suppliers, we are ultimately responsible for ensuring that our products and product candidates, and any other materials that may be used in our preclinical or clinical studies or trials, are manufactured or supplied in accordance with cGMPs. Therefore, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, quality control and quality assurance. Our failure, or the failure of our third-party manufacturers or suppliers, to comply with applicable regulations could result in our product candidates not being approved or sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or approved products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our medicines and harm our business and results of operations.

Any performance failure on the part of our existing or future manufacturers or suppliers, or any interruption or poor yield or quality of manufactured or supplied materials, could delay development or marketing approval. We do not currently have arrangements in place for redundant supply. If any one of our current contract manufacturers or suppliers cannot perform as agreed, we may be required to replace that manufacturer or supplier. Although we believe that there are several potential alternative manufacturers or suppliers who could manufacture or supply our product candidates or the materials for trials relating to product candidates, we may incur added costs and delays in identifying and qualifying any such replacement.

If our third-party manufacturers or suppliers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages. Our research and development activities involve the controlled use of potentially hazardous substances, including chemical and biological materials, by our third-party manufacturers or suppliers. Our manufacturers and suppliers are subject to federal, state and local laws and regulations in the United States governing the use, manufacture, storage, handling and disposal of medical and hazardous materials. Although we believe that our manufacturers’ and our suppliers’ procedures for using, handling, storing and disposing of these materials comply with legally prescribed standards, we cannot completely eliminate the risk of contamination or injury resulting from medical or hazardous materials. As a result of any such contamination or injury, we may incur liability or local, city, state or federal authorities may curtail the use of these materials and interrupt our business operations. In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our resources. We do not have any insurance for liabilities arising from medical or hazardous materials. Compliance with applicable environmental laws and regulations is expensive, and current or future environmental regulations may impair our research, development and production efforts, which could harm our business, prospects, financial condition or results of operations.

 

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Thus, our current and anticipated future dependence upon others for the manufacture or supply of our product candidates or related medicines and materials may adversely affect our development timeline, our future profit margins or our ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis.

Our product candidates may cause undesirable side effects or have other properties that could halt their development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.

It is possible that the FDA or foreign regulatory authorities may not agree with any assessment of the safety profile of our product candidates. Undesirable side effects caused by any of our product candidates could cause us, IRBs, our CROs, the FDA or foreign regulatory authorities to interrupt, delay or discontinue development and could result in a clinical hold on any clinical trial, or the denial of regulatory approval by the FDA or foreign regulatory authorities for any or all targeted indications. This, in turn, could prevent us from commercializing our product candidates and generating revenues from their sale. In addition, if any of our products cause serious or unexpected side effects or are associated with other safety risks after receiving marketing approval, a number of potential significant negative consequences could result, including, but not limited to:

 

   

regulatory authorities may withdraw their approval of this product;

 

   

we may be required to recall the product, change the way it is administered, conduct additional clinical trials or change the labeling of the product;

 

   

the product may be rendered less competitive and sales may decrease;

 

   

our reputation may suffer generally both among clinicians and patients;

 

   

we may be exposed to potential lawsuits and associated legal expenses, including costs of resolving claims;

 

   

regulatory authorities may require certain labeling statements, such as warnings or contraindications or limitations on the indications for use, or impose restrictions on distribution in the form of a Risk Evaluation and Mitigation Strategy (REMS) in connection with approval, if any; or

 

   

we may be required to change the way the product is administered or conduct additional preclinical studies or clinical trials.

If preliminary data demonstrate that any of our product candidates has an unfavorable safety profile and is unlikely to receive regulatory approval or be successfully commercialized, we may voluntarily suspend or terminate future development of such product candidate.

Any one or a combination of these events could prevent us from obtaining approval and achieving or maintaining market acceptance of the affected product or could substantially increase the costs and expenses of commercializing the product candidate, which in turn could delay or prevent us from generating significant revenues from the sale of the product.

We do not have our own laboratory facilities. We rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.

We do not have our own laboratory facilities. We depend upon independent investigators and collaborators, such as universities, medical institutions, CROs and strategic partners to conduct our preclinical studies and clinical trials. We expect to have to negotiate budgets and contracts with CROs and trial sites, which may result in delays to our development timelines and increased costs. We will rely heavily on these third parties over the course of our preclinical studies and clinical trials, and we control only certain aspects of their activities. For example, the CRO of our current ongoing clinical trials of SRA737 was recently acquired by a large global CRO and there may be interruptions in service during their integration. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with applicable protocol, legal, regulatory and scientific standards, and our reliance on third parties does not relieve us of our regulatory responsibilities. We and these third parties are required to comply with GCPs and Good Laboratory Practices (GLPs), which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for clinical and non-clinical research intended to support a submission or application to FDA or the comparable foreign authority. Regulatory authorities enforce these requirements through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any of these third parties fail to comply with applicable requirements, the data generated in our studies and trials may be deemed unreliable and the FDA or foreign regulatory authorities may require us to perform additional studies or trials before approving our marketing applications. We cannot assure you that, upon inspection, such regulatory authorities will determine that any of our studies or trials comply with the GCP or GLP requirements. In addition, our studies and trials must be conducted with drug product produced under cGMPs. Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients may require us to repeat studies or trials, which would delay the regulatory approval process. Moreover, our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

 

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Any third parties conducting our preclinical studies and clinical trials will not be our employees and, except for remedies available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to our ongoing preclinical, clinical and nonclinical programs. These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical studies or other drug development activities, which could affect their performance on our behalf. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our protocols or regulatory requirements or for other reasons, our studies and trials may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.

We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive, or the trials are not well-designed.

Regulatory agencies, IRBs or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants. Clinical trials must be conducted in accordance with GCPs, or other applicable foreign regulatory authority guidelines. Clinical trials are subject to oversight by the FDA, foreign regulatory authorities and IRBs at the study sites where the clinical trials are conducted. In addition, clinical trials must be conducted with product candidates produced in accordance with applicable cGMPs. Clinical trials may be suspended by the FDA, foreign regulatory authorities, or us for various reasons, including, but not limited to:

 

   

deficiencies in the conduct of the clinical trials, including failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols;

 

   

deficiencies in the clinical trial operations or trial sites;

 

   

the product candidate may have unforeseen adverse side effects;

 

   

deficiencies in the trial designs necessary to demonstrate efficacy;

 

   

fatalities or other adverse events (AEs) arising during a clinical trial due to medical problems that may or may not be related to clinical trial treatments;

 

   

the product candidates may not appear to be more effective than current therapies; or

 

   

the quality or stability of the product candidates may fall below acceptable standards.

Although we have never been asked by a regulatory agency, IRB or data safety monitoring board to temporarily or permanently discontinue a clinical trial, if we elect or are forced to suspend or terminate a clinical trial of any of our current or future product candidates, the commercial prospects for that product will be harmed and our ability to generate product revenue from that product may be delayed or eliminated. For example, in June 2016 we decided to suspend the development of our former lead product candidate PNT2258 after an interim analysis of data from a Phase 2 clinical trial on PNT2258 indicated only modest efficacy. Furthermore, any of these events could prevent us or our partners from achieving or maintaining market acceptance of the affected product and could substantially increase the costs of commercializing our product candidates and impair our ability to generate revenue from the commercialization of these products either by us or by our collaboration partners.

Even if we receive regulatory approval to market our product candidates, the market may not be receptive to our products.

Even if we obtain regulatory approval for momelotinib or one of our other product candidates, they may not gain market acceptance among physicians, patients, healthcare payors and/or the medical community. We believe that the degree of market acceptance will depend on a number of factors, including, but not limited to:

 

   

timing of market introduction of competitive products;

 

   

safety and efficacy of our products;

 

   

prevalence and severity of any side effects;

 

   

potential advantages or disadvantages over alternative treatments;

 

   

strength of marketing and distribution support;

 

   

price of our products, both in absolute terms and relative to alternative treatments;

 

   

availability of coverage and reimbursement from government and other third-party payors; and

 

   

sequencing of available products.

 

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If our product candidates are approved for commercial sale and fail to achieve market acceptance, we may not be able to generate significant revenue or achieve or sustain profitability.

We may be subject to requests for access to our product candidates. Demand for compassionate use of our unapproved therapies could strain our resources, delay our drug development activities, negatively impact our regulatory approval or commercial activities, and result in losses.

We are developing product candidates, including momelotinib, to treat life-threatening illnesses for which there are currently limited therapeutic options. Other companies in our field have been the target of campaigns requesting access to unapproved drugs. If we experience similar request for access campaigns, we may experience significant disruption to our business which could result in losses. We are a small company with limited resources, and any unanticipated trials or access programs resulting from requests for access could deplete our drug supply, increase our capital expenditures, and otherwise divert our resources from our primary goals.

In addition, legislation referred to as “Right to Try” laws have been introduced at the local and national levels, which are intended to give patients access to unapproved therapies. New and emerging legislation regarding expanded access to unapproved drugs for life-threatening illnesses could negatively impact our business in the future. Either activism or legislation related to requests for access may require us to initiate an unanticipated expanded access program or to make our product candidates more widely available sooner than anticipated.

Patients who receive access to unapproved drugs through compassionate use or expanded access programs have life-threatening illnesses and generally have exhausted all other available therapies. The risk for serious adverse events, including those which may be unrelated to our product candidates, in this patient population is high and could have a negative impact on the safety profile of our product candidate, which could cause significant delays or an inability to successfully commercialize our product candidate and could materially harm our business. In addition, in order to perform the controlled clinical trials required for regulatory approval and successful commercialization of our product candidates, we may also need to restructure or pause any ongoing compassionate use and/or expanded access programs, which could prompt adverse publicity or other disruptions related to current or potential participants in such programs.

The terms of our Loan and Security Agreement require us to meet certain operating and financial covenants and place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.

Our Loan and Security Agreement is secured by a lien covering substantially all of our assets, excluding our intellectual property and certain other assets. Subject to the terms of the Loan and Security Agreement, we have the option to prepay all, but not less than all, of the amounts borrowed under the Loan and Security Agreement, subject to certain penalty payments, prior to the August 1, 2022 maturity date, at which time all amounts borrowed will be due and payable.

The Loan and Security Agreement contains customary covenants that include, among others, covenants that limit our (including our subsidiaries’) ability to dispose of assets, enter into mergers or acquisitions, incur indebtedness, incur liens, pay dividends or make distributions on our capital stock, make investments or loans, and enter into certain affiliate transactions, in each case subject to customary exceptions for a credit facility of this size and type.

The Loan and Security Agreement contains customary events of default that include, among others, non-payment defaults, covenant defaults, a default in the event a material adverse change occurs, defaults in the event our assets are attached or we are enjoined from doing business, bankruptcy and insolvency defaults, cross-defaults to certain other material indebtedness, material judgment defaults, and inaccuracy of representations and warranties. The occurrence of an event of default could result in an increase to the applicable interest rate of 5.0%, acceleration of and present occurrence of the maturity date, and the consequent obligation for us to repay in full in cash all amounts outstanding under the Loan and Security Agreement, and a right by the lender to exercise all remedies available to it under the Loan and Security Agreement and related agreements, including the right to dispose of the collateral as permitted under applicable law, The Loan and Security Agreement contains customary affirmative and negative covenants, indemnification provisions and events of default. The affirmative covenants include, among others, covenants requiring us to maintain our legal existence and governmental approvals, deliver certain financial reports and maintain certain intellectual property rights. The negative covenants include, among others, restrictions on transferring or licensing our assets, changing our business, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, and creating other liens on our assets, in each case subject to customary exceptions. If we default under the Loan and Security Agreement, the lenders will be able to declare all obligations immediately due and payable and take control of our collateral, potentially requiring us to renegotiate our agreement on terms less favorable to us or to immediately cease operations. Further, if we are liquidated, the lender’s rights to repayment would be senior to the rights of the holders of our common shares to receive any proceeds from the liquidation. If we raise any additional debt financing, the terms of such additional debt could further restrict our operating and financial flexibility

 

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We do not have our own laboratory facilities or the ability to discover product candidates. We rely on licensing, acquisition and other forms of strategic relationship to grow our pipeline. Our efforts to acquire additional product candidates and grow our pipeline may be unsuccessful.

We do not have our own laboratory facilities or the ability to discover product candidates. We rely on licensing, acquisition and other forms of strategic relationship to grow our pipeline. We may acquire, or enter into strategic relationships to identify, license and develop, one or more additional product candidates to grow our pipeline. The identification, evaluation, development and potential acquisition or licensing of additional product candidates is expensive and time-consuming, and our efforts may not lead to the acquisition or licensing of any additional product candidates that can be successfully developed and commercialized. Competition for viable product candidates is intense, and the acquisition or licensing of product candidates may be more expensive than we are able to afford or may require us to seek additional financing. If our efforts do not lead to the acquisition or successful identification, development and licensing of suitable product candidates, we may be unable to grow our pipeline. In addition, if our efforts to grow our pipeline require us to pursue additional dilutive capital or debt financing strategies, we may experience harm to our financial position and stability.

Even if we are successful in continuing to build our pipeline, the potential product candidates that we identify may not be suitable for clinical development. For example, they may be shown to have harmful side effects or other characteristics that indicate that they are unlikely to be drugs that will receive marketing approval and achieve market acceptance. If we do not successfully develop and commercialize product candidates based upon our approach, we will not be able to obtain product revenue in future periods, which likely would result in significant harm to our financial position and adversely affect our stock price.

We face significant competition from other oncology companies, and our operating results will suffer if we fail to compete effectively.

The oncology industry is characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. We may face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions and governmental agencies and public and private research institutions. Any product candidates that we successfully develop and commercialize will compete with existing therapies that are available for the indication or indications for which they are approved and new therapies that may become available in the future.

To our knowledge, there is currently one approved drug that specifically targets JAK inhibition, ruxolitinib, marketed by Incyte Corporation as Jakafi ® in the United States and by Novartis as Jakavi in rest of the world. In addition, there are a number of JAK inhibitor competitors in clinical development, at a similar state of development or more advanced than us. To our knowledge, Celgene Corporation is developing fedratinib, which has reported results from Phase 3 clinical trials, and CTI Biopharma Corporation is developing pacritinib, which has been submitted for regulatory approval in the European Union and is currently in a Phase 2 dose finding study in the United States. However, to our knowledge, there are no approved drugs that target both JAK and ACVR1 inhibition on the market, nor in development. Other competitors include Geron Corporation, which is developing imetelstat in a Phase 2 clinical trial for myelofibrosis, and Acceleron, which is developing luspatercept in a Phase 2 clinical trial for myelofibrosis. If momelotinib is approved, it will compete with existing therapies for the indication or indications for which it is approved. While we believe that momelotinib may have the ability to provide an anemia benefit, which we believe is unique to the JAK inhibition class of agents, the market for momelotinib is competitive, and physicians and other prescribers may not recommend or prescribe momelotinib over other competing products.

To our knowledge, there are no approved drugs that specifically target Chk1 on the market but there are a number of competitors in clinical development, at a similar state of development or more advanced than us. To our knowledge, Genentech, Inc. has conducted a Phase 1/2 clinical trial of an oral Chk1 inhibitor in patients with refractory solid tumors or lymphoma alone and in combination with gemcitabine. To our knowledge, Esperas Pharma is conducting a Phase 1/2 clinical trial of an oral Chk1 inhibitor as monotherapy and in combination with gemcitabine in patients with advanced or metastatic cancer. To our knowledge, Eli Lilly and Company is developing prexasertib, an intravenous Chk1/Chk2 inhibitor in several clinical settings, the most advanced of which are in Phase 2 clinical trials. There are also preclinical programs focused on developing Chk1 inhibitors. If SRA737 is approved, it will compete with existing therapies for the indication or indications for which it is approved.

Additionally, to our knowledge, there are no approved drugs that specifically target Cdc7. To our knowledge, Takeda Pharmaceutical Company is developing an oral Cdc7 inhibitor that is currently in a Phase 2 clinical trial for metastatic pancreatic and colorectal cancers and Eli Lily and Company has a Cdc7 inhibitor program that is currently in a Phase 1 clinical trial being conducted by Cancer Research UK. Other companies may be conducting preclinical studies of Cdc7 inhibitors as well. If SRA141 is approved, it will compete with existing therapies for the indication or indications for which it is approved.

Many of the companies against which we may compete have significantly greater financial and other resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the oncology industry may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or that may be necessary for, our programs.

 

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Our commercial opportunity could be reduced or eliminated if any competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any drugs that we may develop. Our competitors also may obtain FDA or foreign regulatory approval for their product candidates more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. In addition, our ability to compete may be affected in many cases by insurers or other third-party payors seeking to encourage the use of generic drugs. If we fail to complete effectively, our business and operating results would be harmed.

We are dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.

Our ability to compete in the highly competitive oncology industry depends upon our ability to attract and retain highly qualified managerial, scientific and medical personnel. We are dependent on our management, scientific and medical personnel, including Nick Glover, Ph.D., our President and Chief Executive Officer, Barbara Klencke, M.D., our Chief Development Officer and Mark Kowalski M.D., Ph.D., our Chief Medical Officer. The loss of the services of any of our executive officers, other key employees and other scientific and medical advisors, and our inability to find suitable replacements, could result in delays in product development and harm our business.

Our operations are conducted in regions where significant competition exists for key personnel and employees. Many other oncology companies and academic and research institutions are located in these regions. Competition for skilled personnel in these markets is intense and may limit our ability to hire and retain highly qualified personnel on acceptable terms or at all.

To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have provided stock options that vest over time. The value to employees of stock options that vest over time may be 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 on short notice. Although we have employment agreements with our key employees, these employment agreements provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice. We do not maintain “key man” insurance policies on the lives of these individuals or the lives of any of our other employees.

Should momelotinib receive marketing approval in the United States, Canada, or elsewhere in the world, we would need to hire a substantial number of specialized personnel, including field-based personnel, unless we were to collaborate with a third party to commercialize momelotinib. If we are responsible for commercializing momelotinib, we would need to increase our administrative headcount to support such expanded development and commercialization operations with respect to our product candidates. Our ability to attract and retain qualified personnel in the future is subject to intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses and our current financial position. The loss of the services of any of our senior management could delay or prevent the development and commercialization of our product candidates, or have other adverse effects on our business for an indefinite term. In particular, if we lose any members of our current senior management team, we may not be able to find suitable replacements in a timely fashion, if at all, and our business may be harmed as a result.

We may encounter difficulties in managing our expected growth and in expanding our operations successfully.

Prior to acquiring momelotinib, our most advanced product candidate was in Phase 1/2 development. As we advance momelotinib through Phase 3 development, we will need to develop or expand our development, regulatory, manufacturing, marketing and sales capabilities or contract with third parties to provide these capabilities for us. We must also successfully integrate the employees and operations related to the development of momelotinib. Maintaining additional relationships and managing our future growth will impose significant added responsibilities on members of our management. We must be able to manage our development efforts effectively, manage our clinical trials effectively, hire, train and integrate additional management, development, administrative and sales and marketing personnel, improve our managerial, development, operational and finance systems, and expand our facilities, all of which may impose a strain on our administrative and operational infrastructure. Our future financial performance will depend, in part, on our ability to manage this growth effectively. We may not be able to accomplish these tasks, which failure could prevent us from successfully developing our product candidates.

Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

We may seek additional capital through a combination of public and private equity offerings, debt financings, strategic partnerships and alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our stockholders will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our stockholders. The incurrence of indebtedness would result in increased fixed payment obligations

 

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and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates or grant licenses on terms unfavorable to us.

We may form or seek strategic alliances or collaborations in the future. We may be unable to form or enter into such alliances or collaboration arrangements, and we may not realize the expected benefits of any such transaction.

We may form or seek strategic alliances, or create joint ventures or collaborations with third parties that we believe will complement or augment our development and commercialization efforts with respect to our product candidates and any future product candidates that we may acquire or develop. Any of these transactions and relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders, disrupt our management and business, forego potential future economic value or result in the loss of strategic value. These transactions and relationships also may result in a delay in the development of our product candidates if we become dependent upon the other party and such other party does not prioritize the development of our product candidates relative to its other development activities. In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because our product candidates may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy. We cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that would justify such transaction.

Recent and future acquisitions could disrupt our business and harm our financial condition and operating results.

We may acquire additional businesses or product candidates from third parties that we believe will complement or augment our existing pipeline of product candidates, including, for example our recent acquisition of momelotinib from Gilead. Even if the assets we acquire have promising markets or technologies, we may not be able to realize the benefit of acquiring such assets if we are unable to successfully integrate them with our existing operations and company culture. We may encounter numerous difficulties in developing, manufacturing and marketing any new product candidates resulting from an acquisition, including momelotinib, which may delay or prevent us from realizing their expected benefits or enhancing our business. We cannot assure you that, following any such acquisition, we will achieve the expected synergies or benefits from the asset to justify the transaction. The risks we face in connection with acquisitions, including our recent acquisition of momelotinib, include, but are not limited to:

 

   

diversion of management time and focus from operating our business to addressing acquisition integration challenges;

 

   

integration of research and development efforts;

 

   

hiring of key employees with knowledge regarding the acquired asset;

 

   

changes in relationships with strategic partners as a result of product acquisitions or strategic positioning resulting from the acquisition;

 

   

cultural challenges associated with integrating employees, knowledge and processes related to the acquired asset into our organization;

 

   

unanticipated write-offs or charges; and

 

   

litigation or other claims in connection with the acquired asset.

Our failure to address these risks or other problems encountered in connection with acquisitions could cause us to fail to realize the anticipated benefits of these transactions, cause us to incur unanticipated liabilities and harm the business generally. There is also a risk that future acquisitions will result in the incurrence of debt, contingent liabilities, amortization expenses or incremental operating expenses, any of which could harm our financial condition or operating results.

We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to generate product revenue.

We currently have no sales, marketing or distribution capabilities and have no experience in marketing products. If any of our product candidates is approved for sale, we may develop an in-house marketing organization and sales force, which will require significant capital expenditures, management resources and time. We will have to compete with other companies to recruit, hire, train and retain qualified marketing and sales personnel.

If we are unable or decide not to establish internal sales, marketing and distribution capabilities, we will pursue collaborative arrangements regarding the sales and marketing of our products, however, there can be no assurance that we will be able to establish or maintain such collaborative arrangements on commercially reasonable terms, or if we are able to do so, that they will have effective

 

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sales forces. Any revenue we receive will depend upon the efforts of such third parties, which may not be successful. We may have little or no control over the marketing and sales efforts of such third parties and our revenue from product sales may be lower than if we had commercialized our product candidates ourselves. We also face competition in our search for third parties to assist us with the sales and marketing efforts of our product candidates.

We cannot guarantee that we will be able to develop in-house sales and distribution capabilities or establish or maintain relationships with third-party collaborators to commercialize any product in the United States or overseas.

We depend on our information technology and infrastructure.

We rely on the efficient and uninterrupted operation of information technology systems, including mobile technologies, to manage our operations, to process, transmit and store electronic and financial information, and to comply with regulatory, legal and tax requirements. We also depend on our information technology infrastructure for communications among our personnel, contractors, consultants and vendors. System failures or outages could compromise our ability to perform these functions in a timely manner, which could harm our ability to conduct business or delay our financial reporting. Such failures could materially adversely affect our operating results and financial condition.

In addition, we depend on third parties to operate and support our information technology systems. These third parties vary from multi-disciplined to boutique providers, and they may or could have access to our computer networks, mobile networks, and our confidential information. Many of these third parties subcontract or outsource some of their responsibilities to other third parties. As a result, our information technology systems, including those functions that are performed by third parties who are involved with or have access to those systems, are very large and complex. Failure by any of these third-party providers to adequately deliver the contracted services, or maintain confidentiality, could have an adverse effect on our business, which in turn may materially adversely affect our operating results and financial condition. All information technology systems, despite implementation of security measures, may be vulnerable to disability, failures or unauthorized access. If our information technology systems were to fail or be breached, such failure or breach could materially adversely affect our ability to perform critical business functions and sensitive and confidential data could be compromised.

Our internal information technology systems, or those used by our CROs or other contractors or consultants, may fail or suffer security breaches.

Despite the implementation of what we believe are appropriate security measures on internal information technology systems, our internal information technology systems and those of our CROs and other contractors and consultants may become vulnerable to damage from security breaches and/or unauthorized access. The prevalent use of mobile devices also increases the risk of data security incidents. In the ordinary course of our business, we collect, store, process and transmit large amounts of sensitive information, including intellectual property, proprietary business information, personal information and other confidential information. It is critical that we do so in a secure manner in order to ensure the confidentiality, integrity and availability of such sensitive information. We have in the past experienced, and may in the future experience, a security breach. Any material system failure or security breach could cause interruptions in our operations, and could result in a material disruption of our development programs and our business operations. For example, the loss of data from completed or future preclinical studies or clinical trials could result in significant delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Likewise, we rely on other third parties for the manufacture of our product candidates and to conduct studies and trials, and similar events relating to their information technology systems could also have a material adverse effect on our business. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our product candidates could be significantly delayed.

We may be unable to adequately protect our information technology systems from cyberattacks, which could result in the disclosure of confidential information, damage our reputation, and subject us to significant financial and legal exposure.

Cyberattacks are frequent and may be sophisticated and intense to the point that they are difficult to detect. Cyberattacks could include wrongful conduct by hostile foreign governments, industrial espionage, the deployment of harmful malware, denial-of-service, and/or other means to threaten data confidentiality, integrity and availability. A successful cyberattack could cause serious negative consequences for us, including, without limitation, the disruption of operations, the misappropriation of confidential business information and trade secrets, and the disclosure of corporate strategic plans. We have in the past experienced, and may in the future experience, a compromise of our data or information technology systems that results in one or more third parties obtaining access to confidential information about our company. Although we devote resources to protect our information technology systems and continue to assess and, as necessitated, enhance our cybersecurity protection, we realize that cyberattacks are a threat, and there can be no assurance that our efforts will prevent information security breaches that would result in business, legal or reputational harm to us, or would have a material adverse effect on our operating results and financial condition. Confidential information obtained by third parties in connection with past or future attacks could be used in ways that adversely affect our company or our stockholders.

 

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Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.

Our operations, and those of our CROs and other contractors and consultants, could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics and other natural or man-made disasters or business interruptions, for which we may not have insurance coverage. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses. We rely on third-party manufacturers to produce and process our product candidates. Our ability to obtain supplies of our product candidates could be disrupted if the operations of these suppliers are affected by a man-made or natural disaster or other business interruption. Our corporate headquarters are located in Vancouver, British Columbia, which is near a major earthquake fault. Our operations and financial condition could suffer in the event of a major earthquake or other natural disaster near any of our locations.

Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk of fraud or other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors. Misconduct by such individuals could include intentional failures to comply with FDA or international regulations, provide accurate information to the FDA or foreign regulatory authorities, comply with manufacturing standards, comply with federal and state healthcare fraud and abuse laws and regulations, report financial information or data timely, completely and accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Misconduct by third parties could also involve the improper use of information obtained in the course of clinical trials.

We have adopted a code of business conduct and ethics, but it is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial costs. It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations. In addition, the approval and commercialization of any of our product candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.

We face an inherent risk of product liability as a result of the testing of our product candidates and will face an even greater risk if we commercialize any products. For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during 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 or a breach of warranties. Claims could also be asserted under state consumer protection acts. 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. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in, but are not limited to:

 

   

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;

 

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loss of revenue;

 

   

exhaustion of any available insurance and our capital resources;

 

   

the inability to commercialize any product candidate; and

 

   

a decline in our stock price.

We currently hold liability insurance coverage, but that coverage may not be adequate to cover any and all liabilities that we may incur. We would need to increase our insurance coverage when we begin the commercialization of our product candidates, if ever. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be significantly limited, or entirely restricted.

As of December 31, 2017, we had U.S. federal net tax operating loss carryforwards of $31.4 million expiring in 2037 and state operating loss carryforwards of $54.0 million expiring in years ranging from 2022 to 2037. We also had net tax credit carryforwards of $0.4 million which begin to expire in 2032. Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes, such as research tax credits, to offset its post-change income and taxes may be limited. In general, an “ownership change” generally occurs if there is a cumulative change in our ownership by “5% stockholders” that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under state tax laws.

As a result of stock offerings that occurred prior to 2016, subsequent changes in the stock ownership, and the stock offering in February 2017, an ownership change under Section 382 is deemed to have occurred. As such, certain tax attributes existing as of the date of the ownership change are not available for future use. The loss of these attributes did not have any impact on the financial statements since our net U.S. deferred tax assets are offset by a full valuation allowance.

We have experienced ownership changes in the past and may experience ownership changes in the future as a result of future transactions in our stock, some of which may be outside our control. As a result, if we earn net taxable income, our ability to use our pre-change net operating loss carryforwards, or other pre-change tax attributes, to offset U.S. federal and state taxable income and taxes may be subject to limitations.

We are a U.S.-based multinational company subject to tax in certain U.S. and foreign tax jurisdictions. United States federal, state and local, as well as international tax laws and regulations are extremely complex and subject to varying interpretations. Although we believe that our tax estimates and tax positions are reasonable, there can be no assurance that our tax positions will not be challenged by relevant tax authorities or that we would be successful in any such challenge. If we are unsuccessful in such a challenge, the relevant tax authorities may assess additional taxes, which could result in adjustments to, or impact the timing or amount of, taxable income, deductions or other tax allocations, which may adversely affect our results of operations and financial position.

Unstable market and economic conditions may have adverse consequences on our business, financial condition and stock price.

Global credit and financial markets have experienced extreme volatility and disruptions in the past several years, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability. We cannot assure you that further deterioration in credit and financial markets and confidence in economic conditions will not occur. Our general business strategy and stock price may be adversely affected by any such economic downturn, volatile business environment or continued unpredictable and unstable market conditions. If the current equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price and could require us to delay or abandon development plans. In addition, there is a risk that one or more of our current service providers, manufacturers and other partners may not survive these difficult economic times, which could directly affect our ability to attain our operating goals on schedule and on budget.

Our quarterly operating results may fluctuate significantly, which may cause our stock price to fluctuate or decline.

We expect our operating results to be subject to quarterly fluctuations. Our net loss and other operating results will be affected by numerous factors, including, but not limited to:

 

   

variations in the level of expense related to our product candidates or future development programs;

 

   

results of preclinical studies and clinical trials, or the addition or termination of preclinical studies, clinical trials or funding support;

 

   

the timing of the release of results from any preclinical studies and clinical trials;

 

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the timing and amount of milestone and royalty payments to our licensor;

 

   

changes in the competitive landscape or market opportunity for our product candidates;

 

   

our execution of any new collaboration, licensing or similar arrangement, and the timing of payments we may make or receive under such existing or future arrangements or the termination or modification of any such existing or future arrangements;

 

   

any intellectual property infringement lawsuit or opposition, interference or cancellation proceeding in which we may become involved;

 

   

any securities or other litigation in which we may become involved;

 

   

additions and departures of key personnel;

 

   

strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures,

 

   

strategic investments or changes in business strategy;

 

   

the receipt by any of our product candidates of regulatory approval and market acceptance, and the demand for such product candidates;

 

   

regulatory developments affecting our product candidates or those of our competitors; and

 

   

changes in general market and economic conditions.

If our quarterly operating results or expected results from development of our product candidates fall outside the expectations of investors or securities analysts, the price of our common stock could decline substantially. Furthermore, any quarterly fluctuations in our operating results may, in turn, cause the price of our stock to fluctuate substantially. We believe that quarterly comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance.

We face risks related to securities litigation that could result in significant legal expenses and settlement or damage awards.

We are currently and may in the future become subject to claims and litigation alleging violations of the securities laws or other related claims, which could harm our business and require us to incur significant costs. For example, on November 9, 2016, a purported securities class action lawsuit was filed in the United States District Court for the Southern District of New York against us and certain of our executive officers (the New York Lawsuit). The New York Lawsuit was brought by purported stockholders of our company seeking to represent a class consisting of stockholders who purchased stock between July 15, 2015 and June 6, 2016. The New York Lawsuit asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and seeks unspecified damages and other relief. On March 13, 2018, the United States District Court for the Southern District of New York granted the defendants’ motion to dismiss and entered a final judgment dismissing the New York Lawsuit with prejudice. The plaintiffs have filed an appeal.

Also, on November 18, 2016, a purported securities class action lawsuit was filed in the Superior Court of the State of California for the County of San Mateo against us, certain of our executive officers and directors, and the underwriters for our initial public offering (IPO) of our common stock. On February 9, 2017, a substantially identical putative class action suit was filed in the Superior Court of the State of California for the County of San Mateo asserting the same claims on behalf of the same putative class (the two California lawsuits together, the California Lawsuits). The California Lawsuits were brought by purported stockholders of the company seeking to represent a class consisting of stockholders who purchased stock pursuant to and/or traceable to our Registration Statement on Form S-1. The lawsuits assert claims under Sections 11 and 15 of the Securities Exchange Act of 1934 and seek unspecified damages and other relief. On August 1, 2018, all parties reached a mutually acceptable resolution to the California Lawsuits by way of a mediated settlement, which is subject to the parties’ execution of final settlement documents and the approval of the court. The California Lawsuits remain pending. We are generally obliged, to the extent permitted by law, to indemnify our executive officers who are named as defendants in these types of lawsuits. Regardless of the outcome, this or future litigation may require significant attention from management and could result in significant legal expenses, settlement costs or damage awards that could have a material impact on our financial position, results of operations and cash flows.

Risks Related to Government Regulation

We may be unable to obtain U.S. or foreign regulatory approval of our product candidates, and, as a result, we may be unable to commercialize our product candidates.

Our product candidates are, and any future product candidates that we may develop will be, subject to extensive governmental regulations relating to, among other things, research, testing, development, manufacturing, safety, efficacy, approval, recordkeeping, import, export, reporting, labeling, storage, packaging, advertising and promotion, pricing, marketing, distribution, import and export of drugs. Rigorous preclinical testing and clinical trials and an extensive regulatory approval process are required to be successfully

 

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completed before a new drug can be marketed in the United States and in many foreign jurisdictions. Satisfaction of these and other regulatory requirements is costly, time-consuming, uncertain and subject to unanticipated delays. It is possible that none of the product candidates we may develop will obtain the regulatory approvals necessary for us or our collaborators to begin selling them.

As a company, we have very limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including approval by the FDA or foreign regulatory authorities, and, as a company, we have no experience in obtaining approval of any product candidates. The time required to obtain FDA and other approvals is unpredictable but typically takes many years following the initiation of clinical trials, depending upon the type, complexity and novelty of the product candidate. We may encounter delays or rejections during any stage of the regulatory review and approval process based upon the failure of clinical or laboratory data to demonstrate compliance with, or upon the failure of the product candidates to meet, the FDA’s or foreign regulatory authorities’ requirements for safety, efficacy and quality.

The standards that the FDA and foreign regulatory authorities use when regulating us are not always applied predictably or uniformly and can change. Because the product candidates we are developing may represent a new class of drug, the FDA and foreign regulatory authorities have not yet established any definitive policies, practices or guidelines in relation to these drugs. The lack of policies, practices or guidelines may hinder or slow review by the FDA or foreign regulatory authorities of any regulatory filings that we may submit. Moreover, the FDA or foreign regulatory authorities may respond to these submissions by defining requirements we may not have anticipated. Such responses could lead to significant delays in the development of our product candidates.

Any analysis we perform of data from preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. We may also encounter unexpected delays or increased costs due to new government regulations, for example, from future legislation or administrative action, or from changes in FDA or foreign regulatory authority policy during the period of product development, clinical trials and regulatory review. It is impossible to predict whether legislative changes will be enacted, or whether FDA or foreign regulatory authority, guidance or interpretations will be changed, or what the impact of such changes, if any, may be.

In addition, the FDA and/or foreign regulatory authorities may delay, limit, or deny approval of a product candidate for many reasons, including, but not limited to:

 

   

the FDA or foreign regulatory authorities may disagree with the design or implementation of our clinical trials;

 

   

we may be unable to demonstrate to the satisfaction of the FDA or foreign regulatory authorities that a product candidate is safe and effective for any indication;

 

   

we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

 

   

the FDA or foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

 

   

the results of our clinical trials may not demonstrate the safety or efficacy required by the FDA or foreign regulatory authorities for approval;

 

   

the FDA or foreign regulatory authorities may not approve our companion diagnostic, if a companion diagnostic is required;

 

   

we may encounter difficulties coming to agreement with the FDA or foreign regulatory authorities on a pediatric investigation or study plan or may encounter difficulties meeting the terms of the plan, once agreed;

 

   

the FDA or foreign regulatory authorities may find deficiencies in our manufacturing processes or facilities; and

 

   

the FDA’s or foreign regulatory authorities’ approval policies or regulations may significantly change in a manner rendering our clinical data insufficient for approval.

Even if we comply with all of the regulatory requirements of the FDA and foreign regulatory authorities, we may not obtain regulatory approval for any of our product candidates in development. If we fail to obtain regulatory approval for any of our product candidates in development, we will have fewer commercialized products than we anticipate and correspondingly lower revenue.

In addition, because there may be approved treatments for some of the diseases for which we may seek approval, in order to receive regulatory approval, we may need to demonstrate through clinical trials that the product candidates we develop to treat these diseases, if any, are not only safe and effective, but safer or more effective than existing products. Furthermore, in recent years, there has been increased public and political pressure on the FDA with respect to the approval process for new drugs, and the FDA’s standards, especially regarding drug safety, appear to have become more stringent.

Any delay or failure in obtaining required approvals could have a material adverse effect on our ability to generate revenues from the particular product candidate for which we are seeking approval. Furthermore, any regulatory approval to market a product may be subject to limitations on the approved uses for which we may market the product or the labeling or other restrictions. In addition, the FDA has the authority to require a REMS plan as part of or after approval, which may impose further requirements or restrictions on

 

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the distribution or use of an approved product, such as limiting prescribing to certain physicians or medical centers that have undergone specialized training, limiting treatment to patients who meet certain safe-use criteria and requiring treated patients to enroll in a registry. These limitations and restrictions may limit the size of the market for the product and affect reimbursement by third-party payors.

We are also subject to numerous foreign regulatory requirements governing, among other things, the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process varies among countries and may include all of the risks associated with FDA approval described above as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions. Moreover, the time required to obtain approval may differ from that required to obtain FDA approval. Approval by the FDA does not ensure approval by regulatory authorities outside the United States and vice versa.

If we or any collaborators, manufacturers or service providers fail to comply with applicable federal, state or foreign laws or regulations, we could be subject to enforcement actions, which could affect our ability to develop, market and sell our products successfully and could harm our reputation and lead to reduced acceptance of our products by the market. These enforcement actions include, among others:

 

   

adverse regulatory inspection findings;

 

   

warning letters;

 

   

voluntary or mandatory product recalls or public notification or medical product safety alerts to healthcare professionals;

 

   

restrictions on, or prohibitions against, marketing our products;

 

   

restrictions on, or prohibitions against, importation or exportation of our products;

 

   

suspension of review or refusal to approve pending applications or supplements to approved applications;

 

   

exclusion from participation in government-funded healthcare programs;

 

   

exclusion from eligibility for the award of government contracts for our products;

 

   

suspension or withdrawal of product approvals;

 

   

product seizures;

 

   

injunctions; and

 

   

civil and criminal penalties and fines.

In addition, negotiations around the United Kingdom’s exit from the European Union (Brexit) have caused uncertainty in the current regulatory framework in Europe. Brexit has resulted in a decision to move the EMA from the United Kingdom to the Netherlands, with operations currently scheduled to begin in the Netherlands by March 2019. In the United Kingdom, this transition may cause disruption in the administrative and medical scientific links between the EMA and MHRA, including delays in granting clinical trial authorization or marketing authorization, disruption of importation and export of active substance and other components of new drug formulations, and disruption of the supply chain for clinical trial product and final authorized formulations.

The cumulative effects of the disruption to the regulatory framework may add considerably to the development lead time to marketing authorization and commercialization of products in the European Union and/or the United Kingdom. In view of the current lack of detail and resolution with regard to the Brexit implementation, we are unable to confidently predict the effects of such disruption to the regulatory framework in Europe.

Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.

Any regulatory approvals that we receive for our product candidates will require surveillance to monitor the safety and efficacy of the product candidate, and may require us to conduct post-approval clinical studies. The FDA may also require a REMS in order to approve our product candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA or a foreign regulatory authority approves our product candidates, the manufacturing processes, labeling, packaging, distribution, AE reporting, storage, advertising, promotion, import, export and recordkeeping for our product candidates 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 cGMPs and cGCPs for any clinical trials that we conduct post-approval.

 

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Moreover, if we obtain regulatory approval for our product candidates, we will only be permitted to market our products for the indication approved by FDA or foreign regulatory authority, and such approval may involve limitations on the indicated uses or promotional claims we may make for our products, or otherwise not permit labeling that sufficiently differentiates our product candidates from competitive products with comparable therapeutic profiles. For example, we will not be able to claim that our products have fewer side effects, or improve compliance or efficacy unless we can demonstrate those attributes to FDA or foreign regulatory authority in comparative clinical trials.

Later discovery of previously unknown problems with our product candidates, including adverse effects of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

 

   

restrictions on the marketing or manufacturing of our product candidates, withdrawal of the product from the market, or voluntary or mandatory product recalls;

 

   

fines, warning letters, or untitled letters;

 

   

holds on clinical trials;

 

   

refusal by the FDA or foreign regulatory authorities to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;

 

   

product seizure or detention, or refusal to permit the import or export of our product candidates; and

 

   

injunctions, the imposition of civil penalties or criminal prosecution.

The FDA’s and foreign regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of 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 and we may not achieve or sustain profitability.

If we or any of our independent contractors, consultants, collaborators, manufacturers, vendors or service providers fail to comply with healthcare and data privacy laws and regulations, we or they could be subject to enforcement actions, which could result in penalties and affect our ability to develop, market and sell our product candidates and may harm our reputation.

We are or may in the future be subject to federal, state, and foreign healthcare and data privacy laws and regulations pertaining to, among other things, fraud and abuse and patients’ rights. These laws and regulations include:

 

   

the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual for a healthcare item or service, or the purchasing or ordering of an item or service, for which payment may be made under a federal healthcare program such as Medicare or Medicaid;

 

   

the U.S. federal false claims and civil monetary penalties laws, including the federal civil False Claims Act, which prohibit, among other things, individuals or entities from knowingly presenting or causing to be presented, claims for payment by government funded programs such as Medicare or Medicaid that are false or fraudulent, and which may apply to us by virtue of statements and representations made to customers or third parties;

 

   

the U.S. federal Health Insurance Portability and Accountability Act (HIPAA), which created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud healthcare programs;

 

   

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH), which imposes requirements on certain types of people and entities relating to the privacy, security, and transmission of individually identifiable health information, and requires notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable health information;

 

   

the federal Physician Payment Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, to report annually to the Centers for Medicare & Medicaid Services (CMS) information related to payments and other transfers of value to physicians, other healthcare providers and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members, which is published in a searchable form on an annual basis;

 

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state laws comparable to each of the above federal laws, such as, for example, anti-kickback and false claims laws that may be broader in scope and also apply to commercial insurers and other non-federal payors, requirements for mandatory corporate regulatory compliance programs, and laws relating to patient data privacy and security. Other state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; 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 govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and

 

   

in the European Union, the General Data Protection Regulation (GDPR) – Regulation EU 2016/679 – which was adopted in May 2016 and took effect on May 25, 2018. The GDPR is intended to harmonize data protection requirements across the European Union member states by establishing new and expanded operational requirements for entities that process or control personal data generated in the European Union, including consent requirements for disclosing the way personal information will be used, information retention requirements, notification requirements in the event of a data breach, and other requirements.

If our operations are found to be in violation of any such health care laws and regulations, we may be subject to penalties, including administrative, civil and criminal penalties, monetary damages, disgorgement, imprisonment, the curtailment or restructuring of our operations, loss of eligibility to obtain approvals from the FDA or foreign regulatory authorities, or exclusion from participation in government contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid, any of which could adversely our financial results. Although effective compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, these risks cannot be entirely eliminated. Any action against us for an alleged or suspected violation could cause us to incur significant legal expenses and could divert our management’s attention from the operation of our business, even if our defense is successful. In addition, achieving and sustaining compliance with applicable laws and regulations may be costly to us in terms of money, time and resources.

Any products we develop may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices or healthcare reform initiatives, thereby harming our business.

The regulations that govern marketing approvals, pricing, coverage and reimbursement for new drugs vary widely from country to country. Many countries require approval of the sale price of a drug before it can be marketed. The pricing review period begins after marketing or product licensing approval is granted in most cases. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. Although we intend to monitor these regulations, our programs are currently in the early stages of development and we will not be able to assess the impact of price regulations for a number of years. As a result, we might obtain regulatory approval for a product in a particular country, but then be subject to price regulations that delay our commercial launch of the product and negatively impact the revenues we are able to generate from the sale of the product in that country.

Our ability to commercialize any products successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other third-party payors. In many jurisdictions, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. Obtaining coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products. If we are not currently capturing the scientific and clinical data that will be required for reimbursement approval, we may be required to conduct additional trials, which may delay or suspend reimbursement approval. Additionally, in the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained.

Even if we succeed in bringing one or more products to the market, these products may not be considered cost-effective, and the amount reimbursed for any products may be insufficient to allow us to sell our products on a competitive basis. Because our programs are in the early stages of development, we are unable at this time to determine their cost effectiveness or the likely level or method of reimbursement. Increasingly, the third-party payors, such as government and private insurance plans, who reimburse patients or healthcare providers, are requiring that drug companies provide them with predetermined discounts from list prices, and are seeking to reduce the prices charged or the amounts reimbursed for pharmaceutical products. If the coverage provided for any products we develop is inadequate in light of our development and other costs, our return on investment could be adversely affected.

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), established the Medicare Part D program to provide a voluntary prescription drug benefit to patients with disabilities and seniors. Under Part D, Medicare beneficiaries may enroll in prescription drug plans offered by private entities that will provide coverage of outpatient prescription drugs, such as momelotinib, if approved. Medicare Part D coverage is not standardized. Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs, and each drug plan can develop its own drug formulary that identifies which drugs it will cover and

 

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at what tier or level. However, Part D prescription drug formularies must include drugs within each therapeutic category and class of covered Part D drugs, though not necessarily all the drugs in each category or class. Any formulary used by a Part D prescription drug plan must be developed and reviewed by a pharmacy and therapeutic committee. Government payment for some of the costs of prescription drugs may increase demand for products for which we receive regulatory approval. However, any negotiated prices for our products covered by a Part D prescription drug plan will likely be lower than the prices we might otherwise obtain. Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries, private payers often follow Medicare coverage policy and payment limitations in setting their own payment rates. Any reduction in payment that results from the MMA may result in a similar reduction in payments from non-government payers.

Historically, Medicare Part D enrollees have had a partial gap in their coverage (known as the “coverage gap” or “donut hole”) wherein their coinsurance increases from 25% to a higher percentage (35% for brand drugs in 2018) after they reach an initial coverage limit, and remains at that level until they reach a catastrophic coverage threshold where the coinsurance is considerably reduced. However, beginning in 2019, Medicare Part D enrollees will continue to pay a 25% coinsurance during this interval – the same percentage that they were responsible for before they reached the initial coverage limit – thereby closing the coverage gap. The cost of closing the coverage gap is being borne by innovator companies and the government through subsidies. Beginning in 2011, each manufacturer of a drug approved under an NDA was required to enter into a Medicare Part D coverage gap discount agreement and provide a 50% discount on those drugs dispensed to Medicare Part D enrollees in the coverage gap, in order for its drugs to be reimbursed by Medicare Part D. The Bipartisan Budget Act of 2018 increased the manufacturer’s subsidy under this program from 50% to 70% of the negotiated price, beginning in 2019.

Certain products we develop, such as SRA737 and SRA141, if approved, may need to be administered under the supervision of a physician on an outpatient basis. Under applicable U.S. law, certain drugs that are not usually self-administered (including certain injectable drugs) may be eligible for coverage under the Medicare Part B program if:

 

   

they are incident to a physician’s services;

 

   

they are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standards of medical practice; and

 

   

they have been approved by the FDA and meet other requirements of the statute.

There may be significant delays in obtaining coverage for newly-approved products, and coverage may be more limited than the purposes for which the drug is approved by the FDA or foreign regulatory authorities. Moreover, eligibility for coverage does not imply that any drug will be reimbursed in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim payments for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent.

Reimbursement may be based on payments allowed for lower-cost products that are already reimbursed, may be incorporated into existing payments for other services and may reflect budgetary constraints or imperfections in Medicare data. Net prices for products may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of products from countries where they may be sold at lower prices than in the United States. Third-party payors often rely upon Medicare Part D coverage policy and payment limitations in setting their own reimbursement rates. However, no uniform policy requirement for coverage and reimbursement for products exists among third-party payors in the United States. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Our inability to promptly obtain coverage and adequate reimbursement rates from both government-funded and private payors for new drugs that we develop and for which we obtain regulatory approval could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our financial condition.

We believe that the efforts of governments and third-party payors to contain or reduce the cost of healthcare and legislative and regulatory proposals to broaden the availability of healthcare will continue to affect the business and financial condition of oncology companies. A number of legislative and regulatory changes in the healthcare system in the United States and other major healthcare markets have been proposed in recent years, and such efforts have expanded substantially in recent years. These developments have included prescription drug benefit legislation that was enacted and took effect in January 2006, healthcare reform legislation enacted by certain states, and major healthcare reform legislation that was passed by Congress and enacted into law in the United States in 2010. The U.S. Congress and the Trump administration have similarly expressed concerns over the pricing of pharmaceutical products and there can be no assurance as to how this scrutiny will impact future pricing of pharmaceutical products generally. For example, President Trump outlined a blueprint of activities and proposals intended to lower prescription drug prices, which the Department of Health and Human Services is beginning to roll out. Future developments could, directly or indirectly, affect our ability to sell our products, if approved, at a favorable price.

 

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For example, the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act (PPACA), contains provisions that affect companies in the pharmaceutical industry and other healthcare related industries by imposing additional costs and changes to business practices. Provisions affecting pharmaceutical companies include the following.

 

   

mandatory rebates for drugs sold into the Medicaid program were increased, and the rebate requirement was extended to drugs used in risk-based Medicaid managed care plans;

 

   

the 340B Drug Pricing Program under the Public Health Services Act was extended to require mandatory discounts for drug products sold to certain critical access hospitals, cancer hospitals and other covered entities;

 

   

expansion of eligibility criteria for Medicaid programs;

 

   

expansion of entities eligible for discounts under the Public Health Service pharmaceutical pricing program;

 

   

a new Patient Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

 

   

pharmaceutical companies are required to offer discounts on brand-name drugs to patients who fall within the Medicare Part D coverage gap, commonly referred to as the “donut hole”; the Bipartisan Budget Act of 2018 increased the manufacturer’s subsidy under this program from 50% to 70% of the negotiated price, beginning in 2019; and

 

   

pharmaceutical companies are required to pay an annual non-tax deductible fee to the federal government based on each company’s market share of prior year total sales of branded products to certain federal healthcare programs, such as Medicare, Medicaid, Department of Veterans Affairs and Department of Defense. Since we expect our branded pharmaceutical sales, if any of our products are approved, to constitute a small portion of the total federal health program pharmaceutical market, we do not expect this annual assessment to have a material impact on our financial condition.

There have been judicial and Congressional challenges and amendments to certain aspects of the PPACA. President Trump has suggested that he plans to seek repeal of all or portions of the PPACA and indicated that Congress should replace the PPACA with new legislation, and in 2017, President Trump issued the Executive Order Promoting Healthcare Choice and Competition, directing certain federal agencies to modify their implementation of the PPACA. We expect there will be additional challenges, amendments and modifications to the PPACA in the future, including potential repeal of PPACA in full or in part. The full effect of the U.S. healthcare reform legislation on our business activities is unknown. The financial impact of the U.S. healthcare reform legislation will depend on a number of factors, including but not limited to, the policies reflected in implementing regulations and guidance and changes in sales volumes for products affected by the new system of rebates, discounts and fees. The legislation may also have a positive impact on our future net sales, if any, by increasing the aggregate number of persons with healthcare coverage in the United States. Further, new litigation is currently pending before the U.S. Supreme Court to invalidate certain provisions of the PPACA.

Moreover, we cannot predict what healthcare reform initiatives may be adopted in the future. Further federal and state legislative and regulatory developments are likely, and we expect ongoing initiatives in the United States to increase pressure on drug pricing. Such reforms could have an adverse effect on anticipated revenues from product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates.

Our ability to obtain services, reimbursement or funding may be impacted by possible reductions in federal spending in the United States as well as globally.

U.S. federal government agencies currently face potentially significant spending reductions. Under the Budget Control Act of 2011, the failure of Congress to enact deficit reduction measures of at least $1.2 trillion for the years 2013 through 2021 triggered automatic cuts to most federal programs. These cuts would include aggregate reductions to Medicare payments to providers of up to two percent per fiscal year, which went into effect beginning on April 1, 2013 and will stay in effect through 2025 unless additional Congressional action is taken. The American Taxpayer Relief Act of 2012, which was enacted on January 1, 2013, among other things, reduced Medicare payments to several providers, including hospitals and imaging centers. The full impact on our business of these automatic cuts is uncertain.

If government spending is reduced, anticipated budgetary shortfalls may also impact the ability of relevant agencies, such as the FDA or the National Institutes of Health to continue to function at current levels. Amounts allocated to federal grants and contracts may be reduced or eliminated. These reductions may also impact the ability of relevant agencies to timely review and approve drug research and development, manufacturing, and marketing activities, which may delay our ability to develop, market and sell any products we may develop. Any reductions in government spending in countries outside the United States may also impact us negatively, such as by limiting the functioning of international regulatory agencies in countries outside the United States or by eliminating programs on which we may rely.

 

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Obtaining and maintaining regulatory approval for our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of any of our product candidates in other jurisdictions.

Obtaining and maintaining regulatory approval for our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval for a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.

We may also submit marketing applications in other countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidates with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets or receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.

If we or our third-party manufacturers fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

Our research and development activities involve the controlled use of potentially hazardous substances, including chemical and biological materials, by ourselves and our third-party manufacturers. Our manufacturers are subject to federal, state and local laws and regulations in the United States and abroad governing laboratory procedures and the use, manufacture, storage, handling and disposal of medical and hazardous materials. Although we believe that our manufacturers’ procedures for using, handling, storing and disposing of these materials comply with legally prescribed standards, we cannot completely eliminate the risk of contamination or injury resulting from medical or hazardous materials. As a result of any such contamination or injury, we may incur liability or local, city, state or federal authorities may curtail the use of these materials and interrupt our business operations. In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our resources. We do not have any insurance for liabilities arising from medical or hazardous materials. Compliance with applicable environmental, health and safety laws and regulations is expensive, and current or future environmental regulations may impair our research, development and production efforts, which could harm our business, prospects, financial condition or results of operations.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.

In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Recently enacted comprehensive tax reform bill could increase our tax burden and adversely affect our business and financial condition.

The U.S. government has recently enacted comprehensive tax legislation that includes significant changes to the taxation of business entities. These changes include, among others, (i) a permanent reduction to the corporate income tax rate, (ii) revisions to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017 (iii) a partial limitation on the deductibility of business interest expense, (iv) a shift of the U.S. taxation of multinational corporations from a tax on worldwide income to a participation exemption system (along with certain rules designed to prevent erosion of the U.S. income tax base) and (v) a one-time tax on accumulated offshore earnings held in cash and illiquid assets, with the latter taxed at a lower rate.

In addition, beginning in 2022, the newly enacted tax legislation will require U.S. research and experimental expenditures to be capitalized and amortized ratably over a five-year period. Any such expenditures attributable to research conducted outside the U.S. must be capitalized and amortized over a 15-year period. Further, the comprehensive tax legislation, among other things, reduces the orphan drug credit from 50% to 25% of qualifying expenditures. When and if we become profitable, this amortization of research and experimental expenditures and reduction in orphan drug tax credits may result in an increased federal income tax burden, as it may cause us to pay federal income taxes earlier under the revised tax law than under the prior law and, despite being partially off-set by a reduction in the corporate tax rate from a top marginal rate of 35% to a flat rate of 21%, may increase our total federal tax liability.

 

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Notwithstanding the reduction in the corporate income tax rate, the overall impact of this tax reform 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.

Risks Related to Our Intellectual Property

We depend on intellectual property licensed from CPF and Carna, and the termination of these licenses could result in the loss of significant rights, which would harm our business.

Pursuant to a license agreement with CPF, we hold an exclusive license from CPF to use certain patented technology, including certain patent rights, know-how and materials related to SRA737. Either party may terminate the agreement if the other party materially breaches the agreement, subject to certain cure provisions, and CPF may terminate the agreement in certain limited circumstances. We may also terminate the agreement at any time upon 90 days’ prior written notice to CPF. Additionally, pursuant to a license agreement with Carna, we hold an exclusive license from Carna to use certain patented technology, including certain patent rights and know-how related to SRA141. Carna may terminate the agreement in the event of our material breach, subject to certain cure provisions, and we may terminate the agreement at any time upon 30 days’ prior written notice to Carna.

Disputes may arise between us and our licensors regarding intellectual property subject to these license agreements, including with respect to:

 

   

the scope of rights granted under the license agreement and other interpretation-related issues;

 

   

whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

 

   

the amount and timing of milestone and royalty payments;

 

   

the rights of our licensors under the license agreements;

 

   

our right to sublicense patent and other rights to third parties under collaborative development relationships;

 

   

our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates, and what activities satisfy those diligence obligations; and

 

   

the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners.

Any disputes with our licensors over intellectual property that we have licensed from them may prevent or impair our ability to maintain our current licensing arrangements. We depend on these licensed technologies and products to develop our product candidates. Termination of our license agreements could result in the loss of significant rights and could materially harm our ability to further develop and commercialize our product candidates.

If we are not able to obtain and enforce patent protection for our technologies or product candidates, development and commercialization of our product candidates may be adversely affected.

Our success depends in part on our ability to obtain and maintain patents and other forms of intellectual property rights, including in-licenses of intellectual property rights of others, for our product candidates, methods used to manufacture our product candidates and methods for treating patients using our product candidates, as well as our ability to preserve our trade secrets, to prevent third parties from infringing upon our proprietary rights and to operate without infringing upon the proprietary rights of others. Our licensors have filed, and we will continue to file, patent applications directed to the compositions of matter and methods of use related to various aspects of our product candidates.

We and our current or future licensors and licenses may not be able to apply for or prosecute patents on certain aspects of our product candidates or technologies at a reasonable cost in a timely fashion or at all. It is also possible that we or our current licensors, or any future licensors or licensees, will fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection on them. Therefore, our patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. It is possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, such as with respect to proper priority claims, inventorship, claim scope or patent term adjustments. If our current licensors, or any future licensors or licensees, are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised and we might not be able to prevent third parties from making, using, and selling competing products. If there are material defects in the form or preparation of our patents or patent applications, such patents or applications may be invalid and unenforceable. Moreover, our competitors may independently develop equivalent knowledge, methods, and know-how. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business, financial condition and operating results.

 

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There is no guarantee that any of our pending patent applications will result in issued or granted patents, that any of our issued or granted patents will not later be found to be invalid or unenforceable or that any issued or granted patents will include claims that are sufficiently broad to cover our product candidates or technologies or to provide meaningful protection from our competitors. Moreover, the patent position of oncology companies can be highly uncertain because it involves complex legal and factual questions. We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our current and future proprietary technology and product candidates are covered by valid and enforceable patents or are effectively maintained as trade secrets. If third parties disclose or misappropriate our proprietary rights, it may materially and adversely impact our position in the market.

The U.S. Patent and Trademark Office (USPTO) and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case. The standards applied by the USPTO and foreign patent offices in granting patents are not always applied uniformly or predictably. For example, there is no uniform worldwide policy regarding patentable subject matter or the scope of claims allowable in oncology patents. Moreover, changes in either the patent laws or in the interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property. As such, we do not know the degree of future protection that we will have on our proprietary products and technology. While we will endeavor to try to protect our product candidates with intellectual property rights such as patents, as appropriate, the process of obtaining patents is time-consuming, expensive and sometimes unpredictable.

Further, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after it is filed (or 20 years after the filing date of the first non-provisional US patent application to which it claims priority). Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Without patent protection for our product candidates, we may be open to competition from generic versions of our product candidates. Further, the extensive period of time between patent filing and regulatory approval for a product candidate limits the time during which we can market a product candidate under patent protection, which may particularly affect the profitability of our early-stage product candidates.

If we are unable to protect the confidentiality of our trade secrets our business and competitive position would be harmed.

In addition to seeking patent protection for certain aspects of our product candidates and technologies, we also consider trade secrets, including confidential and unpatented know-how important to the maintenance of our competitive position. We protect trade secrets and confidential and unpatented know-how, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to such knowledge, such as our employees, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants that obligate them to maintain confidentiality and assign their inventions to us.

Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts in the United States and certain foreign jurisdictions are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.

Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

Numerous recent changes to the patent laws and proposed changes to the rules of the USPTO may have a significant impact on our ability to protect our technology and enforce our intellectual property rights. For example, the Leahy-Smith America Invents Act (AIA) enacted in 2011 involves significant changes in patent legislation. An important change introduced by the AIA is that, as of March 16, 2013, the United States transitioned to a “first-to-file” system for deciding which party should be granted a patent when two or more patent applications are filed by different parties claiming the same invention. A third party that files a patent application in the USPTO after that date but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by the third party. This will require us to be cognizant going forward of the time from invention to filing of a patent application.

Further, the Supreme Court has ruled on several patent cases in recent years, some of which cases either narrow the scope of patent protection available in certain circumstances or weaken the rights of patent owners in certain situations. These changes have led to increasing uncertainty with regard to the scope and value of our issued patents and to our ability to obtain patents in the future.

 

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Among some of the other changes introduced by the AIA are changes that limit where a patentee may file a patent infringement suit and providing opportunities for third parties to challenge any issued patent in the USPTO. This applies to all of our U.S. patents, even those issued before March 16, 2013. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal court necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action.

Depending on decisions by the U.S. Congress, the U.S. federal courts, the USPTO or similar authorities in foreign jurisdictions, the laws and regulations governing patents could change in unpredictable ways that may weaken our and our licensors’ ability to obtain new patents or to enforce existing patents we and our licensors or partners may obtain in the future.

Once granted, patents may remain open to opposition, interference, re-examination, post-grant review, inter partes review, nullification derivation and opposition proceedings in court or before patent offices or similar proceedings for a given period after allowance or grant, during which time third parties can raise objections against such initial grant. In the course of such proceedings, which may continue for a protracted period of time, the patent owner may be compelled to limit the scope of the allowed or granted claims thus attacked, or may lose the allowed or granted claims altogether.

We, our licensors or any future strategic partners may become subject to third-party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents or other proprietary rights.

We, our licensors or any future strategic partners may be subject to third-party claims for infringement or misappropriation of patent or other proprietary rights that prevent us from developing and commercializing our products. If we, our licensors or any future strategic partners are found to infringe a third-party patent or other intellectual property rights, we could be required to pay substantial damages, potentially including treble damages and attorneys’ fees, if we are found to have willfully infringed. In addition, we, our licensors or any future strategic partners may choose to seek, or be required to seek, a license from a third party, which may not be available on acceptable terms, if at all. Even if a license can be obtained on acceptable terms, the rights may be non-exclusive, which could give our competitors access to the same technology or intellectual property rights licensed to us. If we fail to obtain a required license, we may be unable to effectively market product candidates, which could limit our ability to generate revenue or achieve profitability and possibly prevent us from generating revenue sufficient to sustain our operations. Alternatively, we may need to redesign our infringing products, which may be impossible or require substantial time and monetary expenditure. In addition, we may find it necessary to pursue claims or initiate lawsuits to protect or enforce our patent or other intellectual property rights. The cost to us in defending or initiating any litigation or other proceeding relating to patent or other proprietary rights, even if resolved in our favor, could be substantial, and litigation would divert our management’s attention. 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. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could delay our research and development efforts and limit our ability to continue our operations.

We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.

Competitors may infringe our patents or the patents of our licensors. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. If we were to initiate legal proceedings against a third party to enforce a patent covering one of our products or our technology, the defendant could counterclaim that our patent is invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, for example, lack of novelty, obviousness or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. The outcome following legal assertions of invalidity and unenforceability during patent litigation is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on one or more of our products or certain aspects of our platform technology. Such a loss of patent protection could have a material adverse impact on our business. Patents and other intellectual property rights also will not protect our technology if competitors design around our protected technology without legally infringing our patents or other intellectual property rights.

In addition, in an infringement proceeding, a court may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated, held unenforceable, or interpreted narrowly and could put our patent applications at risk of not issuing. 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.

 

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Interference proceedings provoked by third parties or brought by the USPTO may be necessary to determine the priority of inventions with respect to our patents or patent applications or those of our licensors. An unfavorable outcome could result in a loss of our current patent rights and 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. Litigation or interference proceedings may result in a decision adverse to our interests and, even if we are successful, may result in substantial costs and distract our management and other employees. We may not be able to prevent, alone or with our licensors, misappropriation of our trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as in the United States.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.

We have limited intellectual property rights outside the United States. Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to oncology products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidates and technologies or we could lose certain rights to grant sublicenses.

In connection with our recent acquisition of momelotinib from Gilead, we are required to make aggregate milestone payments of up to $195.0 million to Gilead upon the achievement of certain development, regulatory and commercial milestones, including a milestone payment of $5.0 million upon the initiation of a registrational clinical trial, as well as mid-teen to high twenty percent tiered royalties based upon net sales and additional tiered milestone payments upon reaching certain sales milestones. If we breach any of these obligations, we may be required to indemnify the Seller, subject to certain limitations set forth in the momelotinib purchase.

Additionally, our current license agreements impose, and any future licenses we enter into are likely to impose, various development, commercialization, funding, milestone, royalty, diligence, sublicensing, insurance, patent prosecution and enforcement, and other obligations on us. For example, we are required to use commercially reasonable efforts to develop and commercialize licensed products, and are required to pay CPF and Carna milestone payments in an aggregate amount of up to $319.5 and $270.0 million, respectively, based upon the achievement of certain developmental, regulatory and commercial milestones of SRA737 and SRA141, including a milestone payment of $4.0 million to Carna upon dosing of the first patient in the first Phase 1 clinical trial for SRA141. We are also required to pay CPF tiered high single-digit to low double-digit royalties on the net sales of SRA737 and to pay Carna tiered single-digit royalties on the net sales of SRA141. If we breach any of these obligations, or use the intellectual property licensed to us in an unauthorized manner, we may be required to pay damages and the licensor may have the right to terminate the license, which could result in us being unable to develop, manufacture and sell products that are covered by the licensed technology or enable

 

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a competitor to gain access to the licensed technology. We may also be required to negotiate to return our licensed intellectual property related to SRA737 to CPF if we cease or scale back development and commercialization of SRA737 for oncology-related indications. Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the licensor’s rights. In addition, we may be required to pay significant milestone and royalty payments, depending on the technology and intellectual property we use in products that we successfully develop and commercialize, if any. Therefore, even if we successfully develop and commercialize products, we may be unable to achieve or maintain profitability.

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.

We have received confidential and proprietary information from third parties. In addition, we employ individuals who were previously employed at other oncology companies. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of these third parties or our employees’ former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial cost and be a distraction to our management and employees.

Risks Related to Ownership of Our Common Stock

The market price of our common stock has been and may continue to be volatile, and you may be unable to sell your shares at or above the price at which you purchased them.

The market price of our common stock has been and may continue to be subject to wide fluctuations. For example, we experienced a significant decrease in our stock price after we announced the suspension of the development of our former lead product candidate PNT2258 and the DNAi platform in June 2016. Factors affecting the market price of our common stock include, but are not limited to:

 

   

the timing and results of development activities related to our product candidates;

 

   

the commencement, enrollment or results of future clinical trials we may conduct, or changes in the development status of our product candidates;

 

   

any delay in our regulatory filings for our product candidates and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings;

 

   

disputes with CPF or Carna regarding our licensed technology and products, or with Gilead regarding our acquisition of momelotinib and assumption of the related clinical trials;

 

   

our ability to acquire or in-license new product candidates to grow our pipeline;

 

   

adverse results or delays in preclinical studies or clinical trials;

 

   

changes in laws or regulations applicable to our product candidates, including but not limited to clinical trial requirements for approvals;

 

   

adverse developments concerning our manufacturers;

 

   

our inability to obtain adequate product supply for any approved product or inability to do so at acceptable prices;

 

   

our inability to establish collaborations if needed;

 

   

our failure to commercialize our product candidates;

 

   

additions or departures of key scientific or management personnel;

 

   

unanticipated serious safety concerns related to the use of our product candidates;

 

   

announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

 

   

the size and growth of our initial target markets;

 

   

our ability to successfully treat additional types of cancers or at different stages;

 

   

actual or anticipated variations in quarterly operating results;

 

   

our failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;

 

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publication of research reports about us or our industry, or immunotherapy in particular, or positive or negative recommendations or withdrawal of research coverage by securities analysts;

 

   

changes in the market valuations of similar companies;

 

   

overall performance of the equity markets;

 

   

sales of our common stock by us or our stockholders in the future;

 

   

disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

 

   

significant lawsuits, including patent or stockholder litigation;

 

   

general political and economic conditions; and

 

   

other events or factors, many of which are beyond our control.

In addition, the stock market in general, and oncology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. Securities class action litigation is often instituted against companies following periods of volatility in the market price of a company’s securities. For example, we are currently vigorously defending purported securities class action lawsuits against us and certain of our executive officers. This type of litigation could result in substantial costs and a diversion of management’s attention and resources, which could harm our business, operating results or financial condition.

We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.

We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited to the appreciation of their stock.

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

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act (JOBS Act) enacted in April 2012. For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 (Section 404) of the Sarbanes-Oxley Act of 2002, as amended (Sarbanes-Oxley Act), reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding nonbinding advisory stockholder votes on executive compensation and stockholder approval of any golden parachute payments not previously approved. We cannot predict if investors will find our common stock less attractive because we may 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 will remain an emerging growth company until the earlier of (i) the last day of the fiscal year (a) following the fifth anniversary of the completion of our IPO, (b) in which we have total annual gross revenue of at least $1.07 billion or (c) in which we are deemed to be a large accelerated filer, which requires the market value of our common stock that is held by non-affiliates to exceed $700 million as of the prior June 30th, whichever is earliest; and (ii) the date on which we have issued more than $1 billion in non-convertible debt during the prior three-year period.

Under the JOBS Act, emerging growth companies can also 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, are subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. As a result, changes in rules of U.S. generally accepted accounting principles or their interpretation, the adoption of new guidance or the application of existing guidance to changes in our business could significantly affect our financial position and results of operations.

We incur significantly increased costs and devote substantial management time as a result of operating as a public company.

As a public company, we incur significant legal, accounting and other expenses that we did not incur as a private company. The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the stock exchange upon which our common stock is listed and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel devote a substantial amount of time to these compliance initiatives. Moreover, these

 

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rules and regulations increase our legal and financial compliance costs and make some activities more time-consuming and costly. However, these rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

Pursuant to Section 404, we are required to furnish a report by our management on our internal control over financial reporting. However, while we remain an emerging growth company, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, we are engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effective as required by Section 404.

Additionally, we have in the past and may in the future identify material weaknesses or significant deficiencies in internal control over financial reporting. Under standards established by the Public Company Accounting Oversight Board, a deficiency in internal control over financial reporting exists when the design or operation of a control does not allow management or personnel, in the normal course of performing their assigned functions, to prevent or detect misstatements on a timely basis. A material weakness is a deficiency or combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected and corrected on a timely basis. We cannot assure you that there will not be additional material weaknesses or significant deficiencies that our independent registered public accounting firm or we will identify. If we identify such issues or if we are unable to produce accurate and timely financial statements, our stock price may be adversely affected and we may be unable to maintain compliance with the Nasdaq Stock Market listing requirements.

Provisions in our restated certificate of incorporation and restated bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our common stock.

Our restated certificate of incorporation and restated bylaws contain provisions that could depress the market price of our common stock by acting to discourage, delay or prevent a change in control of our company or changes in our management that the stockholders of our company may deem advantageous. These provisions, among other things:

 

   

establish a classified board of directors so that not all members of our board are elected at one time;

 

   

permit only the board of directors to establish the number of directors and fill vacancies on the board;

 

   

provide that directors may only be removed “for cause” and only with the approval of two-thirds of our stockholders;

 

   

require super-majority voting to amend some provisions in our restated certificate of incorporation and restated bylaws;

 

   

authorize the issuance of “blank check” preferred stock that our board could use to implement a stockholder rights plan (also known as a “poison pill”);

 

   

eliminate the ability of our stockholders to call special meetings of stockholders;

 

   

prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders;

 

   

prohibit cumulative voting; and

 

   

establish advance notice requirements for nominations for election to our board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings.

In addition, Section 203 of the Delaware General Corporation Law may discourage, delay or prevent a change in control of our company. Section 203 imposes certain restrictions on mergers, business combinations and other transactions between us and holders of 15% or more of our common stock.

If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our stock price and trading volume could decline.

The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us or our business. If one or more of the securities or industry analysts who publish research about us downgrade our stock or publish inaccurate or unfavorable evaluations of our company or our stock, the price of our stock could decline. If one or more of these analysts cease coverage of our company, our stock may lose visibility in the market, which in turn could cause our stock price to decline.

 

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ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Unregistered Sale of Equity Securities

On August 21, 2018, the Company granted a warrant to Silicon Valley Bank to purchase 73,529 shares of the Company’s common stock at a price per share of $1.87. Additional shares may be issued upon each draw of any tranche B advance as determined by the principal advance amount, but not to exceed 73,529 shares and upon each draw of any tranche C advance as determined by the principal advance amount, but not to exceed 73,530. In no event will the number of common stock issuable pursuant to the exercise of the warrant exceed 220,588 in the aggregate. The warrant is immediately exercisable and will expire on August 21, 2028.

The issuance of the warrant was exempt from registration under the Securities Act of 1933, as amended, under Section 4(a)(2) thereof as a transaction by an issuer not involving a public offering.

Use of Proceeds

On July 15, 2015, our Registration Statement on Form S-1 (File No. 333-204921) relating to the IPO of our common stock was declared effective by the SEC. Pursuant to such Registration Statement, we sold an aggregate of 9,315,000 shares of our common stock at a price of $17.00 per share for aggregate cash proceeds of approximately $143.6 million, net of underwriting discounts and commissions and offering costs.

In June 2016, we halted investment in PNT2258, our former lead product candidate, based on our review of the interim results from a Phase 2 trial of PNT2258. Accordingly, we now intend to use the remaining net proceeds from our IPO to advance the development of product candidates momelotinib, SRA737 and SRA141, acquire or in-license additional product candidates and technologies and for other general corporate purposes.

 

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

Not applicable.

 

ITEM 4.

MINE SAFETY DISCLOSURES

Not applicable.

 

ITEM 5.

OTHER INFORMATION

None.

 

ITEM 6.

EXHIBITS

The exhibits filed or furnished as part of this Quarterly Report on Form 10-Q are set forth below. Where so indicated, exhibits that were previously filed are incorporated by reference. For exhibits incorporated by reference, the location of the exhibit in the previous filing is indicated.

 

               Incorporated by Reference     

Exhibit
Number

  

Exhibit Description

  

Form

  

File No.

  

Exhibit No.

  

Exhibit
Filing Date

  

Filed/Furnished

Herewith

    2.1#†

   Asset Purchase Agreement dated August 20, 2018 by and between the Registrant and YM Biosciences Australia Pty Ltd, and Gilead Sciences, Inc.                X

    4.1

   Warrant dated August 21, 2018 issued to Silicon Valley Bank.                X

  10.1#

   Loan and Security Agreement dated August 21, 2018, by and between the Registrant and Silicon Valley Bank.                X

 

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               Incorporated by Reference     

Exhibit
Number

  

Exhibit Description

  

Form

  

File No.

  

Exhibit No.

  

Exhibit
Filing Date

  

Filed/Furnished

Herewith

  10.2

   2018 Equity Inducement Plan and forms of award agreements thereunder.                X

  31.1

   Certification of Principal Executive Officer, pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section  302 of the Sarbanes-Oxley Act of 2002.                X

  31.2

   Certification of Principal Financial Officer, pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section  302 of the Sarbanes-Oxley Act of 2002.                X

  32.1*

   Certification of Chief Executive Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.                X

  32.2*

   Certification of Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.                X

101.INS

   XBRL Instance Document.                X

101.SCH

   XBRL Taxonomy Extension Schema Document.                X

101.CAL

   XBRL Taxonomy Extension Calculation Linkbase Document.                X

101.DEF

   XBRL Taxonomy Extension Definition Linkbase Document.                X

101.LAB

   XBRL Taxonomy Extension Labels Linkbase Document.                X

101.PRE

   XBRL Taxonomy Extension Presentation Linkbase Document.                X

 

*

This certification is deemed not filed for purpose of section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.

#

Portions of this exhibit have been omitted based on an application for confidential treatment submitted to the SEC. The omitted portions of this exhibit have been filed separately with the SEC.

Schedules and similar attachments to the agreement have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company will furnish supplementally a copy of any omitted schedule or similar attachment to the SEC upon request.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

    SIERRA ONCOLOGY, INC.
Date: November 8, 2018     By:    /s/ Nick Glover
      Dr. Nick Glover
      President and Chief Executive Officer
      (Principal Executive Officer)
Date: November 8, 2018     By:    /s/ Sukhi Jagpal
      Sukhi Jagpal
      Chief Financial Officer
      (Principal Financial Officer)

 

63

EXHIBIT 2.1

 

     [***]    Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Execution Version

ASSET PURCHASE AGREEMENT

by and among

SIERRA ONCOLOGY, INC.,

YM BIOSCIENCES AUSTRALIA PTY LTD,

and

GILEAD SCIENCES, INC.

(Solely For Purposes of Section 7.1)

Dated as of August 20, 2018

*** Confidential Treatment Requested.


TABLE OF CONTENTS

 

          Page  

Article I

 

DEFINITIONS

 

Section 1.1

   Definitions      1  

Article II

 

PURCHASE AND SALE

 

Section 2.1

   Closing      10  

Section 2.2

   Deliveries      11  

Section 2.3

   Purchase and Sale      11  

Section 2.4

   Excluded Assets      12  

Section 2.5

   Assumption of Certain Liabilities and Obligations      12  

Section 2.6

   RESERVED      13  

Section 2.7

   Transfer of Title; Insurance      13  

Section 2.8

   Consideration      13  

Section 2.9

   Milestone Payments      13  

Section 2.10

   Royalties      15  

Section 2.11

   Taxes      16  

Section 2.12

   Payments      17  

Section 2.13

   Allocation      18  

Section 2.14

   Diligence Obligations      18  

Section 2.15

   Status Reports      19  

Section 2.16

   Patent Prosecution      19  

Section 2.17

   Restrictions on Transfer      19  

Section 2.18

   Delivery of Purchased Assets      20  

Article III

 

REPRESENTATIONS AND WARRANTIES OF SELLER

 

Section 3.1

   Organization and Standing      20  

Section 3.2

   Authorization      20  

Section 3.3

   Binding Agreement      20  

Section 3.4

   Consents; No Violation, Etc.      21  

Section 3.5

   Title to Purchased Assets      21  

Section 3.6

   Litigation      21  

Section 3.7

   Regulatory      21  

Section 3.8

   Intellectual Property      22  

Section 3.9

   Brokers      23  

Section 3.10

   Exclusive Representations and Warranties      23  

 

i


          Page  

Article IV

 

REPRESENTATIONS AND WARRANTIES OF BUYER

 

Section 4.1

   Organization and Standing      24  

Section 4.2

   Authorization      24  

Section 4.3

   Binding Agreement      24  

Section 4.4

   Consents; No Violations, Etc.      24  

Section 4.5

   Litigation      24  

Section 4.6

   No Brokers      24  

Section 4.7

   As-Is Sale      24  

Article V

 

COVENANTS

 

Section 5.1

   Retained Names      25  

Section 5.2

   Non-Assignable Assets; Further Assurances      26  

Section 5.3

   Press Releases; Disclosure      27  

Section 5.4

   Maintenance of Books and Records; Seller’s Access      28  

Section 5.5

   Transfer of Product INDs      28  

Section 5.6

   Assumption of Regulatory Commitments      28  

Section 5.7

   Clinical Trials; Clinical Trial Agreements      29  

Section 5.8

   Adverse Events      30  

Article VI

 

INDEMNITY

 

Section 6.1

   Indemnification by Seller      30  

Section 6.2

   Indemnification by Buyer      30  

Section 6.3

   Claims for Indemnification      31  

Section 6.4

   Survival      32  

Section 6.5

   Limitations      33  

Section 6.6

   Tax Treatment of Indemnification Payments      34  

Article VII

 

MISCELLANEOUS

 

Section 7.1

   GSI Guarantee      34  

Section 7.2

   Interpretation      34  

Section 7.3

   Currency      35  

Section 7.4

   Entire Agreement; Third Party Beneficiaries      35  

Section 7.5

   Notices      35  

Section 7.6

   No Waiver      36  

 

ii


          Page  

Section 7.7

   Amendments      36  

Section 7.8

   Specific Performance      36  

Section 7.9

   Governing Law      36  

Section 7.10

   Jurisdiction; Venue; Consent to Service of Process      36  

Section 7.11

   Waiver of Jury Trial      37  

Section 7.12

   Assignment; Successors and Assigns      37  

Section 7.13

   Severability      37  

Section 7.14

   Counterparts      37  

Exhibit A: Buyer Press Release

 

Exhibit B: Form of Bill of Sale

 

Exhibit C: Form of Patent Assignment Agreement

 

Exhibit D: Assignment and Assumption Agreement

 

Schedule A: Knowledge

 

Schedule B: Trademarks

 

Schedule C: GSI Retained Names

 

Schedule 2.3(b)(i): Purchased Patent Rights

 

Schedule 2.3(b)(ii): Purchase Know-How

 

Schedule 2.3(c)(i): Product Inventory

 

Schedule 2.3(c)(ii): Clinical Samples

 

Schedule 2.3(d): Purchased Records

 

 

iii


INDEX OF DEFINED TERMS

 

Act

     1  

Action

     23  

Additional Amounts

     19  

Affiliate

     1  

Agreed Amount

     34  

Agreement

     1  

Allocation Schedule

     20  

Ancillary Agreements

     1  

Approved Spin-Out Transferee

     21  

Approved Transferee

     21  

Assumed Liabilities

     14  

Bill of Sale

     2  

Business Day

     2  

Buyer

     1  

Buyer Disclosure Schedule

     25  

Buyer Indemnification Cap

     35  

Buyer Indemnified Parties

     32  

Buyer Related Party

     2  

Claim Notice

     34  

Claimed Amount

     34  

Clinical Trial Agreements

     31  

Closing

     12  

Closing Consideration

     2  

Closing Date

     12  

Code

     2  

Combination Product

     2  

Commercially Reasonable Efforts

     2  

Contingent Payment Period

     3  

Contingent Payment Product

     3  

Contingent Royalty Period

     17  

Contracts

     3  

control

     1  

Copyrights

     4  

Cover

     3  

Covered

     3  

Designated Contacts

     32  

EMA

     3  

Encumbrance

     3  

European Union

     3  

Excluded Assets

     13  

Excluded Liabilities

     14  

Exhibits

     3  

[***]

     3  

FDA

     3  

First Commercial Sale

     4  

 

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GAAP

     4  

Governmental Authority

     4  

Governmental Authorization

     4  

GSI

     1  

GSI Retained Name

     4  

Includes

     37  

including

     37  

IND

     4  

Indemnified Party

     33  

Indemnifying Party

     33  

Initiation

     15  

Intellectual Property

     4  

Know-How

     4  

Knowledge

     4  

Law

     4  

Liabilities

     5  

Local Holding Requirements

     22  

Losses

     5  

Material Adverse Effect

     5  

Milestone Event

     14  

Milestone Payment

     15  

Mono Product

     7  

Net Sales

     5  

Non-Assignable Asset

     28  

Non-Assignable Authorization

     28  

Ongoing Clinical Trials

     24  

Parties

     1  

Party

     1  

Patent Assignment Agreement

     8  

Patent Rights

     4  

Permitted Encumbrance

     8  

Permitted License

     9  

Permitted Spin Transaction

     9  

Person

     9  

Pharmaceutical Laws

     23  

Product

     9  

Product INDs

     23  

Purchased Assets

     13  

Purchased IP

     13  

Purchased Know-How

     13  

Purchased Patent Rights

     10  

Purchased Records

     13  

Qualified Transferee

     10  

Registrational Trial

     10  

Regulatory Approval

     10  

Regulatory Exclusivity

     10  

 

v


Retained Names

     10  

Royalties

     16  

Royalty Rates

     16  

Schedules

     10  

SEC

     29  

Seller

     1  

Seller Disclosure Schedule

     22  

Seller Indemnification Cap

     35  

Seller Indemnified Parties

     33  

Seller Taxes

     11  

Selling Person

     5  

Straddle Period

     11  

Tax

     11  

Tax Return

     11  

Third Party

     11  

Third Party Claim

     33  

Threshold

     35  

Trademarks

     4  

Transfer

     12  

Transfer Taxes

     18  

Transferred Assets

     21  

Update Report

     21  

Valid Claim

     12  

 

vi


ASSET PURCHASE AGREEMENT

THIS ASSET PURCHASE AGREEMENT, dated as of August 20, 2018 (this “ Agreement ”), is made by and among Sierra Oncology, Inc., a Delaware corporation (“ Buyer ”), YM Biosciences Australia Pty Ltd, a company organized under the laws of Australia (“ Seller ”), and Gilead Sciences, Inc., a Delaware corporation (“ GSI ”), solely for purposes of Section 7.1. Seller, GSI and Buyer may hereinafter be referred to individually as a “ Party ” and, collectively, as the “ Parties ”.

WHEREAS , Seller desires to sell to Buyer, and Buyer desires to purchase from Seller, the Purchased Assets (as defined below) related to the Product (as defined below), all upon the terms and subject to the conditions hereinafter set forth.

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

ARTICLE I

DEFINITIONS

Section 1.1     Definitions . As used in this Agreement, the following terms have the meanings set forth below:

Act ” means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder.

Action ” has the meaning set forth in Section 3.6.

Additional Amounts ” has the meaning set forth in Section 2.11(b).

Affiliate ” means, as to any Person, any other Person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with, such Person. As used in this definition, “ control ” (including, with its correlative meanings, “controlled by” and “under common control with”) means the possession, directly or indirectly, of the power to direct or cause the direction of management or policies of a Person, whether through the ownership of voting interests, by Contract or otherwise.

Agreed Amount ” has the meaning set forth in Section 6.3(b).

Allocation Schedule ” has the meaning set forth in Section 2.13.

Ancillary Agreements ” means, collectively, the Bill of Sale, the Patent Assignment Agreement and such other agreements as may be executed pursuant to Section 5.2 or Section 5.7.

Approved Transferee ” has the meaning set forth in Section 2.17.

Approved Spin-Out Transferee ” has the meaning set forth in Section 2.17.


Assumed Liabilities ” has the meaning set forth in Section 2.5(a).

Bill of Sale ” means the Bill of Sale to be executed and delivered at Closing, substantially in the form of Exhibit B.

Business Day ” means each day that is not a Saturday, Sunday or other day on which commercial banks in New York, New York are authorized or obligated by Law or executive order to close.

Buyer ” has the meaning set forth in the Preamble.

Buyer Indemnification Cap ” has the meaning set forth in Section 6.5(a)(iii).

Buyer Indemnified Parties ” has the meaning set forth in Section 6.1.

Buyer Related Party ” means [***]

Claim Notice ” has the meaning set forth in Section 6.3(b).

Claimed Amount ” has the meaning set forth in Section 6.3(b).

Clinical Trial Agreements ” has the meaning set forth in Section 5.7(b).

Closing ” and “ Closing Date ” will have the respective meanings given such terms in Section 2.1.

Closing Consideration ” means U.S. $3,000,000.

Code ” means the U.S. Internal Revenue Code of 1986, as amended.

Combination Product ” shall have the meaning set forth in the definition of “Net Sales.”

Commercially Reasonable Efforts ” means, with respect to the efforts to be expended by a Party with respect to a particular objective, those [***]

Contingent Payment Period ” means the period of time commencing on Closing and ending upon expiration of Buyer’s obligations hereunder to pay the Milestone Payments and Royalties.

Contingent Payment Product ” means any pharmaceutical product that either (a) is Covered by a Purchased Patent Right or (b) contains or incorporates the Product.

Contingent Royalty Period ” has the meaning set forth in Section 2.10(a)(i).

Contracts ” means contracts, leases, indentures, agreements, purchase orders and all other legally binding arrangements in existence on the date hereof, including all amendments thereto.

 

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Copyrights ” shall have the meaning set forth in the definition of “Intellectual Property.”

Cover ” or “ Covered ” means, with reference to a Patent Right, that the making of, use, offer for sale, sale, importation or exportation of the applicable product or technology would infringe a Valid Claim of such Patent Right (or, in the case of an application for a Patent Right, would infringe a Valid Claim in such application if it were to issue) in the country in which such activity occurs absent a license thereto or ownership thereof.

Designated Contacts ” has the meaning set forth in Section 5.7(e).

EMA ” means the European Medicines Agency, or any successor agency thereto.

Encumbrance ” means any mortgage, charge, lien, security interest, pledge or encumbrance of any nature whatsoever.

European Union ” means the United Kingdom, France, Germany, Italy and Spain and, without limiting the foregoing, the member states of the European Union as constituted from time to time. For the purposes of this Agreement, the United Kingdom shall at all times be deemed to be a member of the European Union.

Excluded Assets ” has the meaning set forth in Section 2.4.

Excluded Liabilities ” has the meaning set forth in Section 2.5(a).

Exhibits ” means, collectively, the Exhibits referred to throughout this Agreement.

[***] ” means the Ongoing Clinical Trial identified as [***].

FDA ” means the U.S. Food and Drug Administration.

First Commercial Sale ” means the first sale of the applicable product after Regulatory Approval is granted.

GAAP ” has the meaning set forth in the definition of “Net Sales.”

Governmental Authority ” means any U.S. or non-U.S. national, regional, federal, state, provincial, municipal or local governmental, legislative, judicial, administrative or regulatory authority, agency, commission, body or court or arbitrator and any of their respective subdivisions, agencies, instrumentalities, authorities or tribunals.

Governmental Authorization ” means any consent, license, franchise, permit, exemption, clearance or registration issued, granted, given or otherwise made available by or under the authority of any Governmental Authority or pursuant to any Law, including favorable opinions by competent ethics committees.

GSI ” has the meaning set forth in the Preamble.

GSI Retained Name ” means the Trademarks set forth on Schedule C.

 

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IND ” means (i) an Investigational New Drug Application, as defined in the Act, (ii) any equivalent of an Investigational New Drug Application in any jurisdiction outside the United States and (iii) all supplements and amendments that may be filed with respect to the foregoing.

Indemnified Party ” has the meaning set forth in Section 6.3(a)(i).

Indemnifying Party ” has the meaning set forth in Section 6.3(a)(i).

Initiation ” shall have the meaning set forth in Section 2.9.

Intellectual Property ” means all intellectual property throughout the world, including all U.S. and foreign (i) patents, patent applications, and all related continuations, continuations-in-part, divisionals, reissues, re-examinations, substitutions and extensions thereof (“ Patent Rights ”), (ii) trademarks, service marks, names, corporate names, trade names, domain names, logos, slogans, trade dress, design rights and other similar designations of source or origin, together with the goodwill symbolized by any of the foregoing (“ Trademarks ”), (iii) copyrights and copyrightable subject matter (“ Copyrights ”), (iii) trade secrets and all other confidential information, ideas, know-how, inventions, proprietary processes, formulae, models and methodologies (“ Know-How ”), and (iv) all applications and registrations, and any renewals, extensions and reversions, for the foregoing.

Know-How ” shall have the meaning set forth in the definition of “Intellectual Property.”

Knowledge ” of Seller means the actual knowledge of the employees of Seller set forth on Schedule A .

Law ” means any statute, law, ordinance, treaty, requirement, decree, regulatory rule, code or order of a Governmental Authority.

Liabilities ” means any and all debts, liabilities and obligations, whether accrued or fixed, absolute or contingent, matured or unmatured.

Local Holding Requirements ” has the meaning set forth in Section 2.17(b).

Losses ” means, collectively, any and all damages, losses, Liabilities, claims, judgments, penalties, costs and expenses (including reasonable attorneys’ fees and litigation expenses); provided , however , Losses shall not include punitive, consequential, indirect, incidental, exemplary or special damages, lost profits, lost revenue, opportunity costs or any diminution in value, unless, in each instance, awarded to a third party, and shall not be calculated by using or taking into account any multiple of earnings, cash flow, revenue or other similar measure.

Material Adverse Effect ” means an effect which is materially adverse to the Purchased Assets, taken as a whole, but will not include (i) any adverse effect to the extent due to changes in conditions generally affecting (A) the pharmaceutical industry or (B) the economy, financial or securities markets or political, legislative or regulatory conditions, taken as a whole, except in the case of effects referenced in clauses (A) or (B), to the extent such effects disproportionately impact the Purchased Assets, taken as a whole, as compared to similar assets of other companies

 

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in the pharmaceutical industry, (ii) any adverse effect caused by the announcement of this Agreement and the pendency of any of the transactions contemplated hereby, (iii) any adverse effect due to legal or regulatory changes or other binding directives issued by a Governmental Authority except for any such effects that disproportionately impact the Purchased Assets, taken as a whole, as compared to similar assets of other companies in the pharmaceutical industry or (iv) any adverse effect due to acts of natural disaster, war, armed hostility or terrorism.

Milestone Event ” has the meaning set forth in Section 2.9.

Milestone Payment ” has the meaning set forth in Section 2.9.

Mono Product ” shall have the meaning set forth in the definition of “Net Sales.”

Non-Assignable Authorization ” has the meaning set forth in Section 5.2(b).

Non-Assignable Asset ” has the meaning set forth in Section 5.2(a).

Net Sales ” means the gross amounts invoiced for sales of Contingent Payment Products by or on behalf of the Buyer Related Parties and their Affiliates (each, a “ Selling Person ”), less the following deductions, in each case, to the extent specifically related to the applicable Contingent Payment Product and actually taken, paid, accrued, allowed, included or allocated based on a good faith estimate, in the gross sales prices with respect to such sales (and consistently applied as set forth below):

[***]

For the avoidance of doubt, if a single item falls into more than one of the categories set forth in clauses (1) through (8) above, such item may not be deducted more than once. It is understood and agreed that any accruals of amounts reflected in Net Sales shall be periodically (at least on a calendar quarter basis) trued up in a manner consistent with the applicable Selling Person’s customary practices and in accordance with U.S. Generally Accepted Accounting Principles (“ GAAP ”), and Net Sales for the quarter in which such adjustment occurs shall be adjusted to reflect such trued-up amounts.

Net Sales shall be determined using the books and records of the applicable Selling Person and calculated in accordance with GAAP consistently applied throughout the organization and across all products of the Person whose sales of Contingent Payment Products are giving rise to Net Sales. With respect to calculating Net Sales not denominated in U.S. Dollars, the applicable amounts shall be converted from the applicable foreign currency into U.S. Dollars in accordance with Section 2.12(b). Sales of Contingent Payment Products between or among the Selling Persons for use in the production or manufacture of Contingent Payment Products, or for subsequent resale, shall not be included within Net Sales; provided , however , that any subsequent resale of Contingent Payment Products by or on behalf of a Selling Person to another Person other than a Selling Person shall be included within Net Sales.

 

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Net Sales shall also include, with respect to any Contingent Payment Products sold or otherwise disposed of for any consideration other than an exclusively monetary consideration on bona fide arm’s length terms, an amount equal to the higher of (i) the fair market value of all consideration received and (ii) the average sales price for such Contingent Payment Products having the same dosage form and strength during the applicable reporting period in the country where such sale or other disposal occurred when such Contingent Payment Product is sold alone and not with other products, or if such Contingent Payment Product is not sold alone in such country during the applicable reporting period, then an amount equal to the average sales price during the applicable reporting period generally achieved for such Contingent Payment Product having the same dosage form and strength in the rest of the world (or if such Contingent Payment Product is not sold having the same dosage form and strength in the rest of the world, Buyer and Seller shall discuss an appropriate determination of Net Sales for the Contingent Payment Product, and the amount shall equal the amount that is mutually agreed upon by the Parties in good faith, following discussion by Buyer and Seller, based on a mutually agreed upon equitable method of determining the same that takes into account, in the country where such sale or disposal occurred, variations in dosage form and strength).

Notwithstanding the foregoing, Net Sales shall exclude any consideration received with respect to any sale, use or other distribution for use in a clinical trial or other development activity, for compassionate or named-patient use or for use as samples or in test marketing, in each case where Contingent Payment Products are provided at or below cost.

If a Contingent Payment Product consists of or contains a combination of the Product (or the active ingredient in the Product) with one or more other active ingredients, whether sold as a fixed dose combination or as separate doses sold together in a single package as one product (a “ Combination Product ”), the Net Sales for such Combination Product shall be calculated on a country-by-country basis as follows:

(a)    If one or more Persons separately sells in such country, (A) a product containing as its sole active ingredient the active ingredient in the Product in the Combination Product (the “ Mono Product ”) and (B) products containing as their sole active ingredients, the other active ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B), where “A” is the weighted (by sales volume) average sales price (during the period to which the Net Sales calculation applies) for the Mono Product in such country and “B” is the weighted (by sales volume) average sales price (during the period to which the Net Sales calculation applies) in such country, for products that contain as their sole active ingredients the other active ingredients in such Combination Product.

(b)    If one or more Persons separately sells in such country the Mono Product, but one or more Persons does not separately sell in such country products containing as their sole active ingredients, the other active ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction A/C, where “A” is the weighted (by sales volume) average sales price (during the period to which the Net Sales calculation applies) for the Mono Product in such country, and “C” is the weighted (by sales volume) average sales price (during the period to which the Net Sales calculation applies) for such Combination Product in such country.

 

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(c)    If one or more Persons does not separately sell in such country the Mono Product, but one or more Persons does separately sell in such country products containing as their sole active ingredients, the other active ingredients contained in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction (D-E)/D where: “D” is the weighted (by sales volume) average sales price (during the period to which the Net Sales calculation applies) for such Combination Product in such country and “E” is the weighted (by sales volume) average sales price (during the period to which the Net Sales calculation applies) in such country for products that contain as their sole active ingredients the other active ingredients in such Combination Product.

(d)    If one or more Persons does not separately sell in such country both the Mono Product and products containing as their sole active ingredients, the other active ingredient in such Combination Product, the Net Sales attributable to such Combination Product shall be agreed upon by the Parties in good faith (such agreement not to be unreasonably withheld or delayed), following discussion by Buyer and Seller, based on a mutually agreed upon equitable method of determining the relative fair market value of such Mono Product and such other active ingredient or ingredients.

(e)    Notwithstanding the foregoing, if all active ingredients in a Combination Product are Covered by one or more Purchased Patent Rights, the foregoing subsections (a) – (d) shall not apply to calculating Net Sales for such Combination Product.

Ongoing Clinical Trials ” has the meaning set forth in Section 3.7(d).

Party ” and “ Parties ” shall have the meanings set forth in the Preamble.

Patent Assignment Agreement ” means the Intellectual Property assignment agreement, substantially in the form attached as Exhibit C.

Patent Rights ” shall have the meaning set forth in the definition of “Intellectual Property.”

Permitted Encumbrance ” means (i) any Encumbrance for Taxes, assessments and other governmental charges that are not yet due and payable or that may thereafter be paid without penalty, (ii) with respect to permits or Contracts, any restrictions, obligations, limitations or other Encumbrances contained in such permit or Contract or existing at Law or under the regulatory regime pursuant to which such permit is granted or (iii) any license of or other grant of rights to use or obligation with respect to Intellectual Property.

Permitted License ” means any non-exclusive license, sublicense, lease or other grant of rights, in each case, in the ordinary course of business to Third Party service providers.

Permitted Spin Transaction ” means either of the following:

(i) a transfer by Buyer to a Person that is a corporation, limited liability company or similar entity that does not have equity securities registered under the Securities Exchange Act of 1934, as amended, of the equity securities of a wholly-owned subsidiary of Buyer to which any significant portion of the Purchased Assets, or any Purchased Patent Rights or Purchased Know-How, have been Transferred, provided , that (A) [***], (B) all or substantially all of the

 

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Transferred Assets are contributed or sold to such Person in a transaction related to a sale of Buyer and upon consummation of such contribution or sale, such Person (or one of its wholly-owned subsidiaries) will have a management team that (x) [***] or (y) [***] and (C) at the time of the transfer, such Person has at least [***] in cash or cash equivalents net of debt and any other Liabilities including current or deferred Tax Liabilities incurred by such Person in the transaction; or

(ii) a distribution or dividend by Buyer to its stockholders of the equity securities of a wholly-owned subsidiary of Buyer to which any significant portion of the Purchased Assets, or any Purchased Patent Rights or Purchased Know-How, have been Transferred, provided , that (A) all or substantially all of the Transferred Assets are contributed or sold to such wholly-owned subsidiary in a transaction related to a sale of Buyer and upon consummation of such contribution or sale, such wholly-owned subsidiary will have a management team that (x) [***] or (y) [***] and (B) at the time of the distribution or dividend, such wholly-owned subsidiary has at least [***] in cash or cash equivalents net of debt and any other Liabilities including current or deferred Tax Liabilities incurred by such wholly-owned subsidiary in the transaction.

Person ” means any individual, corporation, partnership, limited liability company, joint venture, trust, business association, organization, Governmental Authority or other entity.

Pharmaceutical Laws ” has the meaning set forth in Section 3.7(b).

Product ” means the pharmaceutical product momelotinib, an investigational inhibitor of Janus kinase (JAK).

Product INDs ” has the meaning set forth in Section 3.4.

Purchased Assets ” has the meaning set forth in Section 2.3.

Purchased IP ” has the meaning set forth in Section 2.3(b).

Purchased Know-How ” has the meaning set forth in Section 2.3(b).

Purchased Patent Rights ” means the Patent Rights to the extent set forth on Schedule 2.3(b)(i) , together with all U.S. and foreign divisionals, continuations and continuations-in-part that claim priority thereto; Patents Rights that issue from any of the foregoing; and reexaminations, substitutions, reissues, extensions and renewals of any of the foregoing, including, for clarity, all applications and registrations for the foregoing, and all rights to causes of action and remedies against infringements thereof.

Purchased Records ” has the meaning set forth in Section 2.3(d).

Qualified Transferee ” means a corporation with a class of equity securities registered under the Securities Exchange Act of 1934, as amended, that (i) as of the date of the applicable Transfer, has a market capitalization of at least [***] and (ii) [***].

Registrational Trial ” means a pivotal clinical study for the Contingent Payment Product that is designed to be sufficient to obtain Regulatory Approval.

 

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Regulatory Approval ” means, with respect to a product in a particular jurisdiction, all approvals, licenses, registrations, applications, clearances, filings or authorizations necessary for the commercialization and marketing of such product in such jurisdiction, with the exception of approvals relating to the price at which a pharmaceutical product is sold or can be reimbursed by healthcare insurers, non-profits, government programs or other payors, which type of approvals are not considered Regulatory Approvals.

Regulatory Exclusivity ” means any exclusive marketing rights or data exclusivity rights conferred by any Governmental Authority with respect to a Contingent Payment Product other than Patent Rights, including rights conferred in the United States to a new drug application holder under the Hatch-Waxman Act or the FDA Modernization Act of 1997 (including pediatric exclusivity), or rights similar thereto outside the United States.

Retained Names ” means the Trademarks set forth on Schedule B , and any Trademarks related thereto or containing or comprising any of the foregoing, including any Trademarks derivative thereof or confusingly similar thereto.

Royalties ” has the meaning set forth in Section 2.10(a).

Royalty Rates ” has the meaning set forth in Section 2.10(a).

Schedules ” means, collectively, the Schedules referred to throughout this Agreement.

SEC ” has the meaning set forth in Section 5.3.

Seller ” has the meaning set forth in the Preamble.

Seller Indemnification Cap ” has the meaning set forth in Section 6.5(a)(ii).

Seller Indemnified Parties ” has the meaning set forth in Section 6.2.

Seller Taxes ” means any Taxes of Seller, other than (i) Taxes with respect to the Purchased Assets that relate to a Taxable period (or portion thereof) beginning after the Closing Date, (ii) Additional Amounts payable by Buyer pursuant to Section 2.11(b), and (iii) the portion of Transfer Taxes for which Buyer is liable under Section 2.11(a). For purposes of this Agreement, the Taxes relating to the Purchased Assets that are allocable to the portion of the Straddle Period ending on or before the Closing Date shall be equal to (a) in the case of Taxes other than those described in clause (b), the amount that would be payable if the taxable year of Seller ended on (and included) the Closing Date, and (b) in the case of real, personal and intangible property Taxes and other similar periodic Taxes that are not based on income or receipts, the amount of all such Taxes for the entire Straddle Period multiplied by a fraction, the numerator of which is the number of calendar days in the Straddle Period up to (and including) the Closing Date, and the denominator of which is the number of calendar days in the entire Straddle Period, provided , that if Buyer’s use or ownership of the Purchased Assets causes the Purchased Assets to be exempt from Taxes described in clause (b), the denominator shall be the number of calendar days in the Straddle Period during which such Taxes were imposed.

 

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Straddle Period ” means any taxable period of Seller beginning on or before, and ending after, the Closing Date.

Tax ” means all U.S. federal, state, local and foreign taxes and assessments, including capital gains tax, taxes based upon or measured by gross receipts, income, profits, sales, use, and occupation, and value added, ad valorem, transfer, franchise, withholding, payroll, recapture, escheat, employment, excise, stamp, and property taxes as well as social security (or similar) and unemployment taxes, together with all interest, penalties, and additions imposed with respect to such amounts.

Tax Return ” means any report, return, election, notice, estimate, declaration, information statement and other forms and documents (including all schedules, exhibits and other attachments thereto) relating to and filed or required to be filed with a taxing authority in connection with any Taxes (including estimated Taxes).

Third Party ” means any Person other than Seller or Buyer or their respective wholly-owned subsidiaries.

Third Party Claim ” has the meaning set forth in Section 6.3(a).

Threshold ” has the meaning set forth in Section 6.5(a)(i).

Trademarks ” shall have the meaning set forth in the definition of “Intellectual Property.”

“Transfer” means to directly or indirectly, assign, convey, transfer, license, sublicense, lease or otherwise grant rights.

Transferred Assets ” has the meaning set forth in Section 2.17.

Transfer Taxes ” has the meaning set forth in Section 2.11(a)

Update Report ” has the meaning set forth in Section 2.15.

Valid Claim ” means (a) a claim of an issued and unexpired Patent Right that has not been permanently revoked or declared unenforceable or invalid by a final and unappealable, or unappealed within the time allowed for appeal, decision of a Governmental Authority of competent jurisdiction, or (b) a claim in a pending application for a Patent Right that has been submitted to a patent office and pending for no more than [***] years and that has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.

ARTICLE II

PURCHASE AND SALE

Section 2.1     Closing . The closing of the transactions contemplated by this Agreement (the “ Closing ”) is taking place simultaneously with the execution and delivery of this Agreement at August 20, 2018 (the date of the Closing is referred to in this Agreement as the “ Closing Date ”). All transactions at the Closing shall be deemed to have taken place simultaneously, and each of the closing deliveries is deemed to occur concurrently with each other.

 

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Section 2.2     Deliveries .

(a)    On or prior to the Closing Date, Seller has delivered to Buyer the following:

 

  (i)

the Bill of Sale, duly executed by Seller and/or its Affiliates; and

 

  (ii)

the Patent Assignment Agreement, duly executed by Seller and/or the applicable Affiliate thereof.

(b)    On or prior to the Closing Date, Buyer shall deliver to Seller the following:

 

  (i)

the Closing Consideration, by wire transfer of immediately available funds to the account(s) designated by Seller;

 

  (ii)

the Bill of Sale, duly executed by Buyer; and

 

  (iii)

the Patent Assignment Agreement, duly executed by Buyer and/or the applicable Affiliate thereof.

Buyer shall be responsible for the recording and registration of all assignments and instruments contemplated by this Section 2.2.

Section 2.3     Purchase and Sale . Upon the terms and subject to the conditions of this Agreement, Seller hereby sells, assigns, transfers, conveys and delivers to Buyer, and Buyer hereby purchases, acquires and accepts, all of Seller’s right, title and interest in and to solely the following assets, right and properties of Seller hereto (collectively, the “ Purchased Assets ”):

(a)    all Governmental Authorizations and all pending applications or renewals therefor with respect solely to the Product, in each case to the extent transferable to Buyer under applicable Law, except to the extent set forth in Section 2.4(a);

(b)    (i) the Purchased Patent Rights (including, for clarity, the right to sue for past, present or future infringement or violation of the foregoing); and (ii) the Know-How to the extent set forth on Schedule 2.3(b)(ii) (the “ Purchased Know-How ” and together with such Purchased Patent Rights, the “ Purchased IP ”);

(c)    (i) all assets and inventory, including raw materials and finished goods, owned by Seller and used or held for use exclusively in connection with the development programs with respect to the Product and set forth on Schedule 2.3(c)(i) and (ii) all samples and physical specimens, including plasma and tissue, collected and used or held for use exclusively in connection with the development programs with respect to the Products and in the control of Seller or its Affiliates and set forth on Schedule 2.3(c)(ii) ;

 

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(d)    (i) raw data and reports from preclinical and clinical studies, (ii) regulatory correspondence and meeting minutes, (iii) toxicology and pharmacology reports, (iv) clinical trial protocols and (v) manufacturing batch records and other CMC records, in each case (in respect of the foregoing subsections (i) through (v)), in the control of Seller or its Affiliates and relating solely to the Product and set forth on Schedule 2.3(d) (collectively, the “ Purchased Records ”); and

(e)    the Clinical Trial Agreements, subject to Sections 2.5(b), 5.5, 5.6, 5.7 and 5.8.

Section 2.4     Excluded Assets . Notwithstanding any other provision contained in this Agreement or in the Ancillary Agreements, Seller and Buyer expressly acknowledge and agree that Buyer is not acquiring any right, title or interest in or to any of the assets of Seller or any of its Affiliates that are not specifically identified in Section 2.3 (the “ Excluded Assets ”). For the avoidance of doubt, such Excluded Assets include any and all:

(a)    Governmental Authorizations and all pending applications or renewals therefor with respect to the Product, in each case, as are necessary for Seller to perform its obligations under this Agreement with respect to the Ongoing Clinical Trials, but solely to the extent necessary and until completion of such obligations by Seller (upon which such Governmental Authorizations, applications and renewals shall automatically and without further action of the Parties be deemed to constitute Purchased Assets transferred hereunder);

(b)    compounds and products (other than the Product); and

(c)    Retained Names (including the GSI Retained Name) and other Intellectual Property of Seller or any of its Affiliates other than the Purchased IP.

Buyer acknowledges and agrees that Seller may retain one copy of all or any part of the documentation that is delivered to Buyer hereunder.

Section 2.5     Assumption of Certain Liabilities and Obligations .

(a)    Subject to Sections 2.5(b), 5.5, 5.6, 5.7 and 5.8, Buyer will assume, be responsible for and pay, perform and discharge when due, any and all Liabilities arising from the ownership or use of the Purchased Assets from and after the Closing Date (the “ Assumed Liabilities ”). For the avoidance of doubt, Assumed Liabilities shall include Liabilities that become owed to Third Parties after the Closing as a result of Buyer’s post-Closing activities with respect to the Purchased Assets, including Liabilities arising from the use of inventory manufactured after the Closing; provided , however , that Liabilities resulting from any product liability or similar claims arising from the unexpired inventory manufactured prior to the Closing, used in the ordinary course following the Closing and transferred to Buyer pursuant to Section 2.3(c) shall be an Excluded Liability (as defined below).

 

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(b)    Notwithstanding any other provision contained in this Agreement or in the Ancillary Agreements, but subject to Section 6.2, Seller and Buyer expressly acknowledge and agree that Buyer is not assuming any Liability of Seller or any of its Affiliates that are not Assumed Liabilities or any Liability of Seller for Seller Taxes (the “ Excluded Liabilities ”). Notwithstanding the provisions of Section 2.5(a) or any other provision of this Agreement to the contrary (except for Section 6.2), Seller shall, and shall cause each of its Affiliates to, pay and satisfy in due course all Excluded Liabilities which they are obligated to pay and satisfy. Without limiting the generality of the foregoing, the Excluded Liabilities shall include, but not be limited to, the following: (i) any Liabilities arising out of Excluded Assets; and (ii) any Liabilities relating to pre-Closing activities (regardless of whether such Liabilities are asserted pre-Closing or post-Closing), including, for example, Liabilities Seller or its Affiliates may have to participants in clinical studies for the Product conducted by Seller or its Affiliates prior to the Closing.

Section 2.6     RESERVED .

Section 2.7     Transfer of Title; Insurance . Without limiting any rights and remedies under this Agreement, the title and risk of loss or damage to the Purchased Assets shall pass to Buyer on the Closing Date. As of the Closing Date, the Purchased Assets shall cease to be insured by Seller’s insurance policies or by Seller’s self-insurance, as the case may be, and Buyer shall have no right or obligation with respect to any such policy.

Section 2.8     Consideration . The consideration for the Purchased Assets will consist of (i) the delivery of the Closing Consideration by Buyer to Seller at the Closing and (ii) the assumption by Buyer of the Assumed Liabilities.

Section 2.9     Milestone Payments . From and after the Closing, following the first achievement of each milestone event set forth in the tables below by or on behalf of a Buyer Related Party (each such event, a “ Milestone Event ”), Buyer shall pay, or cause to be paid, to Seller the corresponding milestone payment (each, a “ Milestone Payment ”) (a) within [***] Business Days of the first achievement of each Initiation Milestone and each Approval Milestone, (b) for each Net Sales Milestone achieved during the first three calendar quarters of a year, within [***] days after the end of the calendar quarter in which such Net Sales Milestone is achieved and (c) for each Net Sales Milestone achieved during the fourth ( i.e. , the last) calendar quarter of a calendar year, within [***] after the end of the calendar quarter in which such Net Sales Milestone is achieved. Buyer shall notify Seller as soon as reasonably practicable (i) but no more than [***] Business Days after each Initiation Milestone and each Approval Milestone is first achieved and (ii) but no more than [***] days after the end of the applicable calendar quarter in which each Net Sales Milestone is achieved if achieved during the first three calendar quarters of a calendar year and no more than [***] days after the end of the calendar quarter in which the applicable Net Sales Milestone is achieved if achieved during the fourth ( i.e. , last) calendar quarter of a calendar year. For the avoidance of doubt, each Milestone Payment shall be payable one time only upon the first achievement of the corresponding Milestone Event, regardless of the number of times such Milestone Event may be achieved.

 

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Initiation Milestone

 

Milestone Event    Milestone Payment
Initiation of a Registrational Trial for a Contingent Payment Product. For purposes of this Agreement, “ Initiation ” means the [***].    [***]

 

Approval Milestones
Milestone Event    Milestone Payment
Regulatory Approval for a Contingent Payment Product is granted by the FDA    [***]
Regulatory Approval for a Contingent Payment Product is granted by the EMA (or by the applicable Governmental Authority in a country within the European Union) and the approval from the applicable Governmental Authority establishing price and/or reimbursement is granted for such Contingent Payment Product in at least one of the following countries: U.K., Spain, France, Germany and Italy (provided, that if a Buyer Related Party commercially launches the Contingent Payment Product in such country prior to receipt of such approval establishing price and/or reimbursement, other than named patient sales, then the Milestone Event shall be deemed achieved)    [***]

 

Net Sales Milestones
Milestone Event    Milestone Payment
Annual Net Sales of Contingent Payment Products in a calendar year equals or exceeds [***]    [***]
Annual Net Sales of Contingent Payment Products in a calendar year equals or exceeds [***]    [***]

 

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Section 2.10     Royalties .

(a)      Royalty Payments . Within [***] days of the end of each of the first three calendar quarters of each calendar year and [***] days of the end of each fourth ( i.e. , last) calendar quarter of each calendar year, Buyer shall pay to Seller royalty payments (“ Royalties ”), as calculated by multiplying the applicable royalty rate set forth in the table below (“ Royalty Rates ”) by the corresponding amount of incremental Net Sales of Contingent Payment Products in such calendar quarter.

 

Aggregate Net Sales    Royalty Rate

That portion of aggregate Net Sales that are less than [***] in a calendar year

   [***]

That portion of aggregate Net Sales that are equal to or greater than [***] but less than [***] in a calendar year

   [***]

That portion of aggregate Net Sales that are equal to or greater than [***] but less than [***] in a calendar year

   [***]

That portion of aggregate Net Sales that are equal to or greater than [***] in a calendar year

   [***]

(i)    Buyer’s obligation to pay Royalties with respect to Net Sales of a Contingent Payment Product in a country shall commence on the date of the First Commercial Sale of such Contingent Payment Product in such country and shall continue until expiration of the Contingent Royalty Period. With respect to each Contingent Payment Product and country, the “ Contingent Royalty Period ” means the later of (1) expiration of the [***] year period following the First Commercial Sale of such Contingent Payment Product in such country, (2) expiration of the last-to-expire Valid Claim that Covers such Contingent Payment Product in such country and (3) expiration of [***] for such Contingent Payment Product in such country.

(ii)    Beginning on the date that, and solely for so long as, a Contingent Payment Product is sold in a country and is not Covered by a Valid Claim in such country, then for the purposes of calculating the Royalties attributable to Net Sales of such Contingent Payment Product, the Net Sales of such Contingent Payment Product in such country shall be reduced by [***]. For clarity, if such reduction is applied with respect to a Contingent Payment Product in a country based on the foregoing, and such Contingent Payment Product is later Covered by a Valid Claim in such country, such reduction shall no longer apply so long as a Valid Claim Covers such Contingent Payment Product in such country, provided that, for clarity, no retroactive payment shall be due for that period during which such Contingent Payment Product was not Covered by a Valid Claim in such country.

 

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(b)     Royalty Reports . Within [***] days following the end of each of the first three calendar quarters of each calendar year and within [***] days following the end of each fourth ( i.e. , last) calendar quarter of each calendar year, commencing with the calendar quarter in which the First Commercial Sale of the first Contingent Payment Product occurs, Buyer shall provide Seller with a report containing the following information for the applicable calendar quarter, on a country-by-country, product-by-product basis: (i) the amount of gross sales (including the number and size of units of Contingent Payment Products), (ii) the calculation of Net Sales (including each of the deductions used to calculate such amount) and (iii) the calculation of the Royalties. If no Royalties or other payments are payable to Seller for such reporting period, the report shall state that fact. Notwithstanding the above, the Parties will cooperate reasonably and in good faith to make available to Seller other financial information reasonably requested by Seller in connection with financial reporting obligations.

(c)     Records; Audits . Buyer shall, and shall cause each other Buyer Related Party to, maintain complete and accurate records in sufficient detail to permit Seller to verify the accuracy of any payment made under this Agreement, including the calculation of Royalties and the achievement of Milestone Events. Upon reasonable prior written notice, such records (for periods that have not previously been audited) shall be available not more than once each calendar year during regular business hours for a period of [***] years from the end of the calendar year to which they pertain (or such longer period to the extent required by applicable Law) for examination by an independent certified public accountant selected by Seller and reasonably acceptable to Buyer (and subject to such independent certified public accountant executing an appropriate confidentiality and non-disclosure agreement with the audited party), for the sole purpose of verifying the accuracy of the payments made hereunder. Any amounts shown to be owed but unpaid shall be paid within [***] days from the accountant’s report. Seller shall bear the full cost of such audit unless such audit discloses (i) an underpayment by Buyer of more than [***] of the applicable amount due [***].

Section 2.11     Taxes .

(a)    All transfer, sales, value added, stamp duty and similar Taxes payable in connection with the transactions contemplated hereby (collectively, the “ Transfer Taxes ”) will be borne fifty percent (50%) by Buyer and fifty percent (50%) by Seller. The Party responsible for filing any Tax Return with respect to such Transfer Taxes shall properly and promptly file such Tax Return. Seller and Buyer shall cooperate with each other and use their reasonable efforts to minimize the Transfer Taxes attributable to the transfer of the Purchased Assets, including by effecting the delivery of the Purchased Assets in such a manner as is legally permitted to mitigate such Transfer Taxes, and shall use commercially reasonable efforts to obtain any exemption or other similar certificate from any Governmental Authority as may be necessary to mitigate such Transfer Taxes. Buyer and Seller shall reimburse the other Party for any Transfer Taxes paid by the applicable Party in excess of the amount allocated to such Party by this Section 2.11(a).

(b)    Buyer shall be entitled to deduct from the amounts payable under this Agreement the proper amount of withholding Taxes required to be withheld under applicable Tax Law as determined by Buyer in its reasonable discretion, and Buyer shall timely and properly remit any amounts withheld under this Section 2.11(b) to the appropriate Governmental Authority on behalf of Seller. To the extent Buyer is required to withhold any amounts in respect of Taxes with respect to payments made pursuant to this Agreement, Buyer shall promptly deliver to Seller proof of payment of all such Taxes, together with copies of all communications

 

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from or with such Governmental Authority with respect thereto. Buyer and Seller shall cooperate with each other and use their reasonable efforts to eliminate or minimize any withholding Taxes applicable with respect to payments made pursuant to this Agreement, including providing appropriate forms, including Internal Revenue Service forms W-9 or W-8BEN-E, to eliminate or reduce any such withholding. Amounts withheld pursuant to this Section 2.11(b) will be treated as paid to Seller hereunder. Notwithstanding the foregoing, if Buyer (i) assigns, delegates or otherwise transfers any of its rights or obligations under this Agreement to an Affiliate or successor pursuant to Section 2.17, Section 7.12(a) or Section 7.12(b), and such Affiliate or successor is required by applicable Law to deduct or withhold Taxes in respect of any amounts payable under this Agreement at a rate higher than the rate at which Buyer would have been required to deduct or withhold Taxes if such assignment or transfer had not occurred, or (ii) takes any other similar action that causes Buyer to be required to deduct or withhold Taxes in respect of any amounts payable under this Agreement at a rate higher than if such action had not been taken, then the sum payable under this Agreement shall be increased as necessary so that after making all required deductions or any required withholding (including deductions and withholding with respect to additional sums payable under this Section 2.11(b)) Seller shall receive an amount equal to the sum that would have been paid if such assignment or transfer had not been made, or action had not been taken, as applicable. Additional amounts payable by Buyer pursuant to this Section 2.11(b) are referred to as “ Additional Amounts ”. For clarity, in the event of any assignment, delegation or other transfer of rights or obligations by Seller pursuant to Section 7.12, the Additional Amounts shall not exceed the Additional Amounts that would have been payable had such assignment, delegation or other transfer of rights or obligations not occurred. If Buyer or Seller, as the case may be, assigns, delegates or otherwise transfers any of its rights or obligations under this Agreement to an Affiliate or successor pursuant to Section 2.17, Section 7.12(a) or Section 7.12(b), the provisions of this Section 2.11(b) shall apply with respect to such Affiliate or successor, as applicable.

(c)    Except for Taxes covered by Sections 2.11(a) and 2.11(b), each Party shall be responsible for any Tax obligations of its own due to this Agreement (including income tax not withheld at source and capital gains tax). Subject to Section 2.5(a) and Article VI, neither Party shall have any obligation towards the other Party in the event that the other Party fails to fully comply with its Tax obligations.

Section 2.12     Payments .

(a)    Without limiting either Party’s right to assert or obtain damages for breaches of this Agreement, Buyer’s right to set off as set forth in Section 6.5(d) hereto and solely with respect to Royalties, Buyer’s right to true-up accruals of amounts reflected in Net Sales in accordance with the definition for “Net Sales” set forth herein, all Milestone Payments and Royalties to be paid to Seller hereunder shall be non-refundable and noncreditable. All payments to be made to Seller in accordance with the provisions of this Agreement will be made by wire transfer in U.S. Dollars of immediately available funds to the credit of Seller’s bank account as may be designated in writing by Seller from time to time.

 

 

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(b)    Buyer agrees, in determining amounts hereunder, it will use Buyer’s then current standard procedures and methodology generally applied by Buyer or its Affiliates in preparing its audited financial statements for the applicable calendar quarter including Buyer’s then current standard exchange rate methodology for the translation of foreign currency sales into U.S. Dollars or, in the case of Selling Persons who are not Affiliates of Buyer, such similar methodology, consistently applied. Buyer will inform Seller as to the specific exchange rate translation methodology used for a particular country or countries. In addition, Buyer will notify Seller prior to changing or implementing its exchange rate translation methodology.

(c)    If, by reason of applicable Law in any country, it becomes impossible or illegal to pay any Milestone Payment or Royalty due hereunder in U.S. Dollars, Buyer shall promptly notify Seller and (i) to the extent permitted by applicable Law, such payments shall be deposited in local currency in the relevant country to the credit of Seller in a recognized banking institution designated by Seller or, if none is designated by Seller within thirty (30) days of such notice from Buyer, in a recognized banking institution selected by Buyer and identified in a written notice provided to Seller, and (ii) to the extent not permitted under applicable Law, such payments shall be negotiated promptly and in good faith by the Parties.

(d)    Buyer shall pay interest on any amount due that is not paid on or before the date such payments are due under this Agreement, after the expiration of [***] day grace period, at an annual rate equal to [***] as published in The Wall Street Journal (or a successor publication thereof) in effect on the date such payment was required to be made, calculated on the total number of days payment is delinquent.

Section 2.13     Allocation . Seller shall prepare and deliver to Buyer a preliminary allocation of the consideration (including any liabilities assumed for U.S. federal income Tax purposes) among the Purchased Assets in accordance with Section 1060 of the Code and the U.S. Treasury regulations thereunder (and any similar provision of state, local or foreign Law, as appropriate) on the Closing Date, which preliminary allocation may be updated by Seller within thirty (30) days after the Closing Date. Buyer shall review the preliminary allocation and any updates made by Seller and provide any reasonable objections or comments within fifteen (15) days after the receipt thereof, which Seller shall reasonably consider. The preliminary allocation, reflecting Buyer’s reasonable comments and any updates made by Seller, shall become final thirty (30) days after Buyer’s receipt thereof (the “ Allocation Schedule ”). Any subsequent adjustments to the consideration for the Purchased Assets shall be reflected in amendments to the Allocation Schedule as determined by Seller, and subject to Buyer’s reasonable comments, in a manner consistent with Section 1060 of the Code and the U.S. Treasury regulations thereunder (and any similar provision of state, local or foreign Law, as appropriate). Seller, Buyer and their respective Affiliates shall report and file Tax Returns in accordance with the Allocation Schedule. Neither Seller nor Buyer shall take any position (whether in audits, Tax Returns or otherwise) that is inconsistent with such Allocation Schedule unless required to do so by applicable Law.

Section 2.14     Diligence Obligations . At all times during the Contingent Payment Period, Buyer shall, and shall cause any Buyer Related Party to, comply with all applicable Laws with respect to developing, commercializing and otherwise exploiting, and shall use Commercially Reasonable Efforts to develop, commercialize and otherwise exploit (including obtain Regulatory Approval for), the Contingent Payment Products.

 

 

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Section 2.15     Status Reports . Until the First Commercial Sale of each Contingent Payment Product, Buyer shall send to Seller a reasonably detailed status report of the development, manufacture and commercialization of such Contingent Payment Product and the status of efforts to achieve the Milestone Events once each year (each such report, an “ Update Report ”), with the first such Update Report due in January of 2019 and subsequent Update Reports due in January of each applicable year. Within thirty (30) days after receipt of each Update Report, if Seller requests a meeting with representatives of Buyer to discuss such report, Buyer shall make available for such a meeting, upon reasonable notice during regular business hours, those of its and the other Buyer Related Parties’ employees and representatives that are responsible for the applicable activities set forth in the Update Report.

Section 2.16     Patent Prosecution . Buyer shall file, prosecute and maintain the Purchased Patent Rights, based on reasonable commercial and patent prosecution strategy considerations, in accordance with commercially reasonable practices for biopharmaceutical companies of a comparable size to obtain intellectual property protection for pharmaceutical products comparable to the Contingent Payment Products (but without taking into account the particular circumstances of Buyer, including any other product opportunities of Buyer and amounts payable to Seller hereunder).

Section 2.17     Restrictions on Transfer .

(a)    During the Contingent Payment Period, Buyer shall not, and shall cause its Affiliates not to Transfer (other than in a Permitted License) to any Third Party (x) any significant portion of the Purchased Assets or (y) any Purchased IP (collectively, the “ Transferred Assets ”) unless, (i)(A) the assignee or other transferee is a Qualified Transferee and such Transfer occurs at least [***] after the Closing Date or (B) Seller or GSI has consented in writing to such Transfer, [***] and, provided, further, that Seller and GSI shall be deemed to have consented if neither Seller nor GSI respond to any request for consent within [***] days of the receipt of such request (any assignee or other transferee of any Transfer under the foregoing (A) or (B), an “ Approved Transferee ”), and (ii) such Approved Transferee expressly assumes in writing Buyer’s obligations relating to the Transferred Assets and under this Agreement, including Buyer’s obligation to pay all amounts due under this Agreement to Seller that relate to such Transferred Assets (including, for clarity, any and all Contingent Payment Products). Buyer shall ensure that each Approved Transferee (if any) shall not, and shall cause its Affiliates not to Transfer to any Third Party any Transferred Assets unless the requirements specified in this Section 2.17(a) is satisfied.

(b)    During the Contingent Payment Period, Buyer shall not and shall cause its Affiliates not to directly or indirectly, assign, convey or otherwise transfer (including through any distribution of the equity securities or other ownership rights of any wholly-owned subsidiary of Buyer or other form of spin-off) any of the equity interests of any subsidiary of Buyer to which any significant portion of the Purchased Assets or any Purchased IP have been Transferred (other than in a Permitted License) unless (i)(A)(1) such assignment, conveyance or other transfer of any of the equity interests of any subsidiary of Buyer is pursuant to a Permitted Spin Transaction and such Transfer occurs at least [***] after the Closing Date or (2) Seller or GSI has consented in writing to such Transfer, [***] and, provided, further, that Seller and GSI shall be deemed to have consented if neither Seller nor GSI respond to any request for consent

 

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within [***] days of the receipt of such request (any assignee or other transferee of any Transfer under the foregoing (1) or (2), an “ Approved Spin-Out Transferee ”) and (B) such Approved Spin-Out Transferee expressly assumes in writing Buyer’s obligations relating to the Transferred Assets and under this Agreement, including Buyer’s obligation to pay all amounts due under this Agreement to Seller that relate to such Transferred Assets (including, for clarity, any and all Contingent Payment Products) or (ii) such assignment, conveyance or other transfer of any of the equity interests of any subsidiary of Buyer (A) is to a wholly-owned subsidiary of Buyer (and in the case of certain local de minimis holding requirements (“ Local Holding Requirements ”), to a subsidiary that Buyer directly or indirectly holds all of the equity interests in other than equity interests held by another Person for purposes of Local Holding Requirements) and (B) is for the purpose of Buyer’s internal tax planning. Buyer shall ensure that each Approved Spin-Out Transferee (if any) shall not, and shall cause its Affiliates not to Transfer any Transferred Assets unless the requirements specified in each of this Section 2.17(b)(i) or 2.17(b)(ii) are satisfied.

Section 2.18     Delivery of Purchased Assets . Notwithstanding any Non-Assignable Assets that are to be treated in accordance with Section 5.2, Seller shall deliver each of the Purchased Assets to Buyer, and Buyer shall receive and accept such Purchased Assets, as soon as practicable on or after the Closing Date, but no later than ninety (90) days or such other date mutually agreed to by the Parties. The Parties shall reasonably coordinate on the methods, timing and other details regarding such delivery of the Purchased Assets.

ARTICLE III

REPRESENTATIONS AND WARRANTIES OF SELLER

Seller represents and warrants to Buyer that the statements in this Article III are true, complete and correct as of the date hereof (unless the particular statement speaks expressly as of another date, in which case it is true, complete and correct as of such other date), subject, in any case, to the exceptions provided in the disclosure schedule supplied by Seller to Buyer, dated as of the date hereof (the “ Seller Disclosure Schedule ”), with specific reference to the sections or subsections hereof, as applicable, to which such exception relates (except to the extent that it is readily apparent on the face of such disclosure that it also qualifies or applies to other sections or subsections hereof):

Section 3.1     Organization and Standing . Seller is a company duly organized, validly existing and in good standing under the Laws of Australia.

Section 3.2     Authori zation . Seller has all requisite power and authority to execute this Agreement, to carry out and perform its obligations under this Agreement and to consummate the transactions contemplated to be performed by it hereunder. The execution, delivery and performance by Seller of this Agreement, and the consummation of the transactions contemplated hereunder, have been duly and validly authorized by all necessary action of Seller.

Section 3.3     Binding Agreement . This Agreement has been duly and validly executed and delivered on behalf of Seller and, assuming the due authorization, execution and delivery by Buyer, constitutes the legal and binding obligation of Seller enforceable against Seller in accordance with its terms, subject to the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting creditors’ rights generally and to general equity principles (whether considered in a proceeding in equity or at law).

 

 

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Section 3.4     Consents; No Violation, Etc . Except for any filings with Governmental Authorities or other Governmental Authorizations necessary to transfer the INDs relating to the Product (the “ Product INDs ”) and Purchased IP, the execution and delivery of this Agreement does not, and the consummation of the transactions contemplated hereby will not (i) violate any Law applicable to Seller, (ii) conflict with any provision of the certificate of incorporation or by-laws of Seller, (iii) give rise to any approval, authorization, consent, license, filing or registration with any court, arbitrator or Governmental Authority or (iv) violate any material Contract of Seller, or to which Seller is a party or subject to or by which it or any of its assets or properties is otherwise bound; provided , however , that no representation or warranty is made in the foregoing clauses (i), (iii) or (iv) with respect to matters that, individually or in the aggregate, would not be material and adverse to the Purchased Assets as a whole.

Section 3.5     Title to Purchased Assets . Seller has good and valid title to all of the tangible Purchased Assets held by Seller, free and clear of all Encumbrances, other than Permitted Encumbrances.

Section 3.6     Litigation . As of the date hereof, there is no suit, claim, action, proceeding or investigation (“ Action ”) pending or, to the Knowledge of Seller, threatened against (a) Seller relating to the Purchased Assets or (b) the Purchased Assets.

Section 3.7     Regulatory .

(a)    Seller has made available to Buyer complete and correct copies of (i) all Product INDs and (ii) all Purchased Records. All Product INDs are in full force and effect and there are no facts that would constitute a material default or noncompliance under the Product IND.

(b)    With respect to the Purchased Assets, Seller is in compliance with the Act, including the regulations promulgated thereunder, and any state or foreign Laws applicable to the development, testing, safety or efficacy of pharmaceutical products (“ Pharmaceutical Laws ”), except as would not, individually or in the aggregate, have a Material Adverse Effect. Seller has not received any written, or, to Seller’s Knowledge, other notice from the FDA or any other Governmental Authority alleging noncompliance with any Pharmaceutical Law or initiating, or threatening to initiate, any action to suspend or terminate a Product IND. In connection with the Purchased Assets, Seller has not and, to the Knowledge of Seller, Seller’s officers, employees, agents or clinical investigators acting for Seller have not (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority or (iii) committed any other act, made any statement or failed to make any statement, that establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy, or for any other Governmental Authority to invoke such a policy.

 

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(c)    Seller has filed with the FDA and other applicable Governmental Authorities all required material filings, declarations, listings, registrations, reports, applications or submissions, including but not limited to Product INDs and adverse event reports, required by Pharmaceutical Laws in connection with the Purchased Assets. All such filings, declarations, listings, registrations, reports, applications or submissions were in material compliance with applicable Pharmaceutical Laws when filed and remain in full force and effect.

(d)    All preclinical and clinical investigations or trials sponsored by or conducted on behalf of Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and Laws restricting the use and disclosure of individually identifiable health information. Seller has not received any written notice or other correspondence from the FDA or any other Governmental Authority commencing, or threatening to initiate, any action to place a clinical hold order on, or to terminate, delay, suspend, or materially modify any proposed or ongoing clinical or pre-clinical studies or tests sponsored by or conducted on behalf of Seller relating to the Purchased Assets. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “ Ongoing Clinical Trials ”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product.

(e)    Neither Seller nor, to the Knowledge of Seller, any officer, employee, or agent of Seller has been convicted of any crime or engaged in any conduct in connection with the Purchased Assets that has resulted in or could reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar Pharmaceutical Law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in connection with the Purchased Assets that could reasonably be expected to result in such a material debarment or exclusion that are pending or, to the Knowledge of Seller, threatened against Seller or any of its respective officers, employees, agents or clinical investigators.

Section 3.8     Intellectual Property .

(a)    As of the date hereof, the Purchased Patent Rights constitute all Patent Rights owned by Seller and its Affiliates that are directed to and Cover the manufacture, use, and composition of matter of the Product. The Purchased Patent Rights are in effect and subsisting. Seller has not entered into any written (i) consent, (ii) forbearance or covenant not to sue or (iii) settlement agreement, in each case, with respect to the Purchased IP, and to the Knowledge of Seller as of the date hereof, there are no pending Actions filed, or threatened in writing, against the Seller or any of its Affiliates which challenge (including oppositions, interferences and similar actions) the validity or enforceability of, or Seller’s ownership of or right to use, the Purchased IP.

 

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(b)    Seller solely owns on an exclusive basis, free and clear of all Encumbrances (other than Permitted Encumbrances), the Purchased IP. Neither Seller nor any of its Affiliates is obligated to pay to, and does not receive from, any Third Party (other than its Affiliates pursuant to Contracts that will terminate, be terminated or otherwise have no force or effect, in each case, with respect to the Purchased IP as of Closing) any royalty with respect to the Purchased IP, nor is Seller or any of its Affiliates a party to any Contract pursuant to which it has licensed or otherwise granted any rights to any Third Party (other than its Affiliates pursuant to Contracts that will terminate, be terminated or otherwise have no force or effect, in each case, with respect to the Purchased IP as of Closing) to use any of the Purchased IP other than clinical trial agreements, contract manufacturing agreements, agreements with contract research organizations and other service providers, and other agreements entered into in the ordinary course of business in which the grant of rights to use Intellectual Property is incidental and not material to performance under the Agreement. To the Knowledge of Seller as of the date hereof, Seller is not subject to any judgment of any Governmental Authority with respect to, nor is it a party to any Contract which restricts or impairs the use by Seller or any of its Affiliates of, any Purchased IP.

(c)    (i) To the Knowledge of Seller as of the date hereof, the development, manufacture or commercialization of the Product as of the date hereof does not infringe, misappropriate or otherwise violate any Person’s Intellectual Property and as of the date hereof, no such Action is pending, or to the Knowledge of Seller as of the date hereof, threatened in writing, against Seller or any of its Affiliates, and (ii) to the Knowledge of Seller as of the date hereof, no Person is infringing, misappropriating or otherwise violating any Purchased IP, and as of the date hereof, no such Action is pending or threatened in writing against any Person by Seller or any of its Affiliates. This Section 3.8 constitutes the only representation and warranty of Seller with respect to Intellectual Property, including any actual or alleged infringement, misappropriation or other violation of any Intellectual Property of any other Person.

Section 3.9     Brokers . No broker, investment banker, financial advisor or other Person is entitled to any broker’s, finder’s, financial advisor’s or similar fee or commission in connection with the transactions contemplated by this Agreement based upon arrangements made by or on behalf of Seller, except those for which Seller will be solely responsible.

Section 3.10     Exclusive Representations and Warranties . Other than the representations and warranties set forth in this Article III, Seller is not making any other representations or warranties, express or implied, with respect to the Product or any of the Purchased Assets. Seller hereby disclaims any other express or implied representations or warranties, including, without limitation, regarding any financial projections or other forward-looking statements provided by or on behalf of Seller.

ARTICLE IV

REPRESENTATIONS AND WARRANTIES OF BUYER

Buyer represents and warrants to Seller that the statements in this Article IV are true, complete and correct as of the date hereof (unless the particular statement speaks expressly as of another date, in which case it is true, complete and correct as of such other date), subject, in any case, to the exceptions provided in the disclosure schedule supplied by Buyer to Seller, dated as of the date hereof (the “ Buyer Disclosure Schedule ”), with specific reference to the sections or subsections hereof, as applicable, to which such exception relates (except to the extent that it is readily apparent on the face of such disclosure that it also qualifies or applies to other sections or subsections hereof):

Section 4.1     Organization and Standing . Buyer is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware.

 

 

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Section 4.2     Authori zation . Buyer has all requisite corporate power and authority to execute this Agreement, to carry out and perform its obligations under this Agreement and to consummate the transactions contemplated to be performed by it hereunder. The execution, delivery and performance by Buyer of this Agreement, and the consummation of the transactions contemplated hereunder, have been duly and validly authorized by all necessary action of Buyer.

Section 4.3     Binding Agreement . This Agreement has been duly and validly executed and delivered on behalf of Buyer and, assuming the due authorization, execution and delivery by Seller, constitutes the legal and binding obligation of Buyer enforceable against Buyer in accordance with its terms, subject to the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting creditors’ rights generally and to general equity principles (whether considered in a proceeding in equity or at law).

Section 4.4     Consents; No Violations, Etc. The execution and delivery of this Agreement do not, and the consummation of transactions contemplated hereby will not (i) violate any Law applicable to Buyer, (ii) conflict with any provision of the certificate of incorporation or by-laws of Buyer, (iii) give rise to any approval, authorization, consent, license, filing or registration with any court, arbitrator or Governmental Authority or (iv) violate any material Contract of, or to which Buyer is a party or subject to or by which it or any of its assets or properties is otherwise bound; provided , however , that no representation or warranty is made in the foregoing clauses (i), (iii) or (iv) with respect to matters that, individually or in the aggregate, would not materially interfere with Buyer’s performance of its obligations hereunder.

Section 4.5     Litigation . As of the date hereof, there is no Action pending or, to the knowledge of Buyer, threatened against Buyer or any of its Affiliates, which (i) challenges the transactions contemplated by this Agreement, (ii) if adversely determined would delay the ability of Buyer to perform its obligations hereunder or (iii) would have a material adverse effect on Buyer.

Section 4.6     No Brokers . No broker, investment banker, financial advisor or other Person is entitled to any broker’s, finder’s, financial advisor’s or similar fee or commission in connection with the transactions contemplated by this Agreement based upon arrangements made by or on behalf of Buyer, except those for which Buyer will be solely responsible.

 

 

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Section 4.7     As-Is Sale . BUYER ACKNOWLEDGES AND AGREES THAT: (I) THE REPRESENTATIONS AND WARRANTIES OF SELLER SPECIFICALLY SET FORTH IN ARTICLE III OF THIS AGREEMENT CONSTITUTE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES OF SELLER TO BUYER AND SELLER DOES NOT MAKE ANY OTHER REPRESENTATION OR WARRANTY OF ANY KIND OR NATURE, AND BUYER HAS NOT RELIED ON ANY REPRESENTATION OR WARRANTY MADE TO BUYER OR ANY OF ITS EMPLOYEES, AGENTS, STOCKHOLDERS, AFFILIATES OR REPRESENTATIVES, EXPRESS OR IMPLIED, AT LAW OR IN EQUITY, REGARDING THE PURCHASED ASSETS OR THE SUBJECT MATTER OF THIS AGREEMENT, OUTSIDE THOSE SET FORTH IN ARTICLE III OF THIS AGREEMENT, AND ANY SUCH OTHER REPRESENTATIONS OR WARRANTIES ARE HEREBY EXPRESSLY DISCLAIMED; (II) SELLER HAS MADE NO REPRESENTATION OR WARRANTY WITH RESPECT TO ANY FORECASTS, FINANCIAL OR OTHERWISE; AND (III) BUYER IS PURCHASING THE PURCHASED ASSETS ON AN “AS-IS, WHERE-IS” BASIS.

ARTICLE V

COVENANTS

Section 5.1     Retained Names .

(a)    Buyer hereby acknowledges that, as between the Parties and each of their respective Affiliates, all right, title and interest in and to the Retained Names (including the GSI Retained Name) are owned exclusively by Seller and/or its respective Affiliates. Buyer further acknowledges that, except as expressly set forth in Section 5.1(b), it has no rights, and is not acquiring any rights, to use the Retained Names. In no event shall Buyer or any of its Affiliates hold themselves out as having any affiliation with Seller or any of its Affiliates.

(b)    Upon and following the Closing, Buyer shall, and shall cause its Affiliates to, cease using any and all Retained Names, except that, during the period [***] immediately following Closing, Buyer and its Affiliates shall be permitted to use the GSI Retained Name in the manner that the GSI Retained Name was used by Seller and its Affiliates immediately prior to Closing solely in connection with the use of any inventory of Products in the Ongoing Clinical Trials; provided that , such inventory is included in the Purchased Assets described in Section 2.3(c) and the existing packaging depicts the GSI Retained Name. As of the Closing or, with respect to the GSI Retained Name, following expiration of the period of permitted use as described in the immediately preceding sentence, Buyer shall, and shall cause its Affiliates to, remove, strike over or otherwise obliterate all Retained Names from all Purchased Assets, including any packaging materials and other inventory in respect of the Product, and other materials transferred hereunder, except in the case of debossed pills of Product (which, for clarity, Buyer shall be required to destroy). Any use by Buyer of the GSI Retained Name as permitted in this Section 5.1(b) is subject to the following conditions: (i) use of the GSI Retained Name shall be in a form and manner, and with standards of quality, of that in effect for the GSI Retained Name as of the Closing, (ii) the GSI Retained Name shall not be used in a manner that may reflect negatively on such name and marks or on Seller or its Affiliates, (iii) Buyer and its Affiliates shall not apply to register or register any of the Trademarks forming a part of or associated with the Retained Names and (iv) Buyer and its Affiliates shall, in connection with all written uses of the GSI Retained Name (including on any packaging materials and other inventory), include a clear statement that the associated products or services are manufactured by or otherwise emanate from Buyer and its Affiliates and not from Seller and its Affiliates. Seller shall have the right to terminate the foregoing, effective immediately, if Buyer and its Affiliates

 

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fail to comply with the foregoing terms and conditions or otherwise fail to comply with any reasonable direction of Seller in relation to the use of the Retained Names. Buyer and its Affiliates shall indemnify and hold harmless Seller and any of its Affiliates for any Losses arising from or relating to the use by Buyer or any of its Affiliates of the Retained Names pursuant to this Section 5.1(b). Each of the Parties acknowledges and agrees that the remedy at Law for any breach of the requirements of this Section 5.1(b) would be inadequate and agrees and consents that without intending to limit any additional remedies that may be available, Seller and its Affiliates shall be entitled to a temporary or permanent injunction, without proof of actual damage or inadequacy of legal remedy, and without posting any bond or other undertaking, in any Action which may be brought to enforce any of the provisions of this Section 5.1(b).

Section 5.2     Non-Assignable Assets; Further Assurances .

(a)    Notwithstanding anything to the contrary contained in this Agreement, if the conveyance, assignment, transfer or delivery or attempted conveyance, assignment, transfer or delivery to Buyer of any of the Purchased Assets (i) is prohibited by any applicable Law or (ii) would require any authorizations, approvals, consents or waivers from another Person to convey, assign, transfer or deliver such asset, and such authorizations, approvals, consents or waivers have not been obtained prior to the Closing (each, a “ Non-Assignable Asset ”), in either case, the Closing shall proceed, but the Closing shall not constitute the conveyance, assignment, transfer or delivery of such Non-Assignable Asset, and this Agreement shall not constitute a conveyance, assignment, transfer or delivery of such Non-Assignable Asset unless and until such authorization, approval, consent or waiver is obtained. After the Closing, the Parties shall continue to use commercially reasonable efforts and cooperate with each other, without additional consideration, to obtain any such authorization, approval, consent or waiver as promptly as practicable, it being understood that (i) Seller shall not be required to pay any consideration to any other Person (unless Buyer agrees to reimburse Seller for such amounts), offer or grant any accommodation (financial or otherwise) to obtain any authorization, approval consent or waiver of such other Person and (ii) to the extent the foregoing shall require any action that would, or would continue to negatively affect Buyer following the Closing, such action shall require the consent of Buyer. Once authorization, approval or waiver of or consent for the conveyance, assignment, transfer or delivery of any such Non-Assignable Asset is obtained, Seller shall convey, assign, transfer and deliver such Non-Assignable Asset to Buyer at no additional cost to Buyer but subject to the immediately foregoing sentence. Pending such transfer, Seller shall (i) cooperate with Buyer or its designees in any commercially reasonable arrangement designed to provide Buyer or its designee with all of the rights and benefits of the Non-Assignable Assets after the Closing as if Buyer owned such Non-Assignable Assets. The Parties agree that upon the Closing, Buyer shall be treated as the owner of any Non-Assignable Asset for U.S. federal income Tax purposes.

(b)    With respect to any Governmental Authorization that is a Non-Assignable Asset (a “ Non-Assignable Authorization ”), notwithstanding any other provision of this Agreement, Seller’s liabilities and obligations with respect thereto shall cease in all respects as of the date that is two (2) years after the Closing. On and after such date, Seller shall have no ongoing liabilities or obligations to Buyer whatsoever in relation to such Non-Assignable Authorizations or the Products approved, cleared, marketed or sold under such Non-Assignable Authorizations, including any obligation to assist in the transfer of any such Non-Assignable Authorizations. On and after such date, Seller shall have the right, exercisable in its sole discretion, to cease, or cause to cease, the maintenance of such Non-Assignable Authorizations in the applicable issuing countries or territories, and to terminate the same.

 

 

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(c)    After the Closing Date each of the Parties will execute and deliver, or cause to be executed and delivered (without any additional consideration), (i) such assignments, deeds, bills of sale and other instruments of transfer as either Party reasonably may request as necessary or desirable in order to effect or further evidence the sale and assignment of the Purchased Assets to Buyer and the retention of the Excluded Assets by Seller, and (ii) such assumption agreements and other instruments of assumption as either Party reasonably may request as necessary or desirable in order to effect or further evidence the assumption of the Assumed Liabilities, or to obtain releases of Seller or Buyer and their respective Affiliates, as applicable from any Liability with respect to the Assumed Liabilities or Excluded Liabilities, as applicable.

(d)    Notwithstanding anything to the contrary contained in this Agreement or any Ancillary Agreement, Buyer shall be responsible for preparing and filing all instruments and documents necessary to effect the assignment of the Purchased IP to Buyer (other than the Patent Assignment Agreement to be delivered pursuant to Section 2.2) and all costs and expenses with respect thereto, including preparing and recording country-specific assignments and legalization of signatures (where required), and following Buyer’s reasonable request, Seller shall reasonably cooperate with Buyer (and Buyer shall reimburse Seller for its reasonable out-of-pocket costs), with respect to the foregoing for a period of [***] following the Closing.

Section 5.3     Press Releases ; Disclosure . Neither Buyer nor Seller shall, and Buyer and Seller shall cause of each of their respective Affiliates not to, issue a press release, trade announcement or any other public announcement with regard to the transactions contemplated hereby without the other Party’s prior consent, which shall not be unreasonably withheld or delayed. This restriction shall not apply to (i) the Buyer’s press release announcing the transaction in the form attached hereto as Exhibit A and (ii)  announcements required by applicable Law or any Governmental Authority, however, in connection with subsection (ii) hereto, the Parties shall, to the extent reasonably practicable, coordinate and work in good faith to create mutually acceptable announcements. To the extent any Party is required to file a copy of this Agreement or any Ancillary Agreement as an exhibit to any filings with the U.S. Securities and Exchange Commission (the “ SEC ”) or any Governmental Authority, the Parties agree to request confidential treatment for the commercially sensitive portions of this Agreement or any Ancillary Agreement to be so filed with the SEC or any Governmental Authority. Further, to the extent any Party is required to file a copy of this Agreement or any Ancillary Agreement as an exhibit to any filings with the SEC or any Governmental Authority, then such Party shall prepare a draft of such filing for the other Party’s review and comment, including a proposed redacted version of this Agreement to be filed as an exhibit to such draft, if such filing includes disclosure of this Agreement or any Ancillary Agreement and its terms. Such draft filing and proposed redacted version of this Agreement shall be provided to the other Party reasonably in advance of the deadline for such filing, and the other Party shall promptly (and in any event, no fewer than five (5) days or such shorter time to meet any filing deadline where it was not practical to provide the other Party with such notice) provide its input in a reasonable manner in order to allow the Party seeking disclosure to file within the timelines proscribed by

 

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the regulations of the SEC or applicable Governmental Authority, which input the Party seeking such disclosure will reasonably consider. The Party seeking such disclosure will exercise commercially reasonable efforts to obtain confidential treatment for the commercially sensitive portions of this Agreement or any Ancillary Agreement from the SEC or applicable Governmental Authority as represented by the redacted version reviewed by the other Party. If a Current Report on Form 8-K is to be filed by Buyer with respect to this Agreement, then Buyer shall not file a copy of this Agreement in or as in exhibit to such Form 8-K.

Section 5.4    Maintenance of Books and Records; Seller’s Access. For a period of [***] after the Closing Date, or until the [***], (i) Buyer agrees to retain (and to cause its Affiliates to retain) and make available all data and books and records received from Seller and its Affiliates for inspection and copying by Seller or its agents at Seller’s expense, upon reasonable request and upon reasonable notice; provided that such data and books and records shall be made available only to the extent such availability is required for Seller or one or more of its Affiliates to comply with a requirement of Law, this Agreement, the Ancillary Agreements or to enable Seller or one or more of its Affiliates to defend against, respond to, or otherwise participate in any litigation, investigation, audit process, subpoena or other proceeding related to the Product, and (ii) no such data and other books and records shall be destroyed by Buyer without giving thirty (30) days prior written notice to Seller to permit Seller, at Seller’s sole cost, to duplicate or take possession of any such data, books and records. Any such access by Seller shall not unreasonably interfere with the conduct of the business of Buyer and its Affiliates. Seller will hold, and will use commercially reasonable efforts to cause its officers, directors, employees, accountants, counsel, consultants, advisors and agents to hold, in confidence, unless compelled to disclose by judicial or administrative process or by other requirements of applicable Law, all confidential documents and information concerning Buyer provided to it pursuant to this Section 5.4.

Section 5.5     Transfer of Product INDs . Buyer and Seller shall, as promptly as practicable and in any event within [***] days after the Closing Date, each notify the FDA in writing of the transfer of ownership and all rights to the Product INDs to Buyer in accordance with all applicable Laws. Buyer concurrently shall notify the FDA in writing of the change of ownership to the Product. Product INDs in any jurisdiction outside the United States shall be closed or transferred to Buyer on a country-by-country basis as specified in the transition plan.

Section 5.6     Assumption of Regulatory Commitments . From and after the Closing Date and in accordance with the transition plan, Buyer will assume control of, and responsibility for all costs, obligations and Liabilities arising from or related to any commitments or obligations to any Governmental Authority involving the Product, but only to the extent such Liabilities (i) arise from facts and circumstances occurring after the Closing Date and (ii) do not arise from or relate to any breach by Seller of its obligations or any of its Affiliates obligations. Notwithstanding the foregoing, from and after the Closing Date, Seller shall be responsible for certain regulatory commitments in accordance with the transition plan until such regulatory commitments become the responsibility of Buyer or, if earlier, are fulfilled.

 

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Section 5.7     Clinical Trials; Clinical Trial Agreements .

(a)    Seller has begun the process of winding-down the Ongoing Clinical Trials, including [***], in accordance with accepted pharmaceutical industry norms and ethical practices. Buyer shall assume responsibility to conduct and complete the Ongoing Clinical Trials, including the responsibilities specified in the transition plan, as soon as reasonably practicable after the Closing Date (and in no event later than [***] or as extended to such other date as mutually agreed upon by the Parties, according to the transition plan). After the Closing Date and in accordance with the transition plan, Seller and/or its applicable Affiliates shall be responsible for maintaining certain activities related to the Ongoing Clinical Trials, which are specified in the transition plan, until such activities become the responsibility of Buyer in accordance with the transition plan or, if earlier, are completed. From and after the Closing, Buyer hereby grants Seller rights and access to all applicable Purchased Assets to the extent needed to satisfy Seller’s obligations specified in the transition plan or otherwise herein with respect to the Ongoing Clinical Trials. The Parties agree to cooperate in good faith and to use commercially reasonable efforts to satisfy the obligations specified in the transition plan and any other agreement referred to in the transition plan.    

(b)    In connection with the Ongoing Clinical Trials, Seller has entered into clinical trial-related agreements (the “ Clinical Trial Agreements ”) with Third Parties with respect to the performance of the Ongoing Clinical Trials. Seller will cause to be transferred to Buyer any and all Clinical Trial Agreements as identified in the transition plan. To effect any such transfer, Buyer will execute and deliver to Seller, and Seller will cause to be executed and delivered to Buyer, an Assignment and Assumption Agreement substantially in the form of Exhibit D. In the event that Seller is unable to assign a Clinical Trial Agreement to Buyer after the Closing, Buyer may enter into a separate agreement in place of the unassignable Clinical Trial Agreement. In addition, after the Closing, Seller will terminate any or all such Clinical Trial Agreements as Buyer may so request, if possible and if permitted by Seller’s ethical practices. If any Clinical Trial Agreement is not earlier terminated by Seller at Buyer’s request nor transferred to Buyer or a Party promptly designated by Buyer by or before the end of the transition plan, Seller will, if possible and if permitted by Seller’s ethical practices, terminate such Clinical Trial Agreements unless continuing good faith efforts are being made to transfer the Clinical Trial Agreement to Buyer. Buyer shall remain free to enter into its own agreements in place of those so terminated.

(c)    Except as set forth in Section 5.7(e) below or Section 5.5, Section 5.6, 5.7(a) or 5.7(b) above, Buyer will have the right to control all aspects of the Ongoing Clinical Trials. Therefore, Seller will exercise such rights as it may have, and will cause any of its Affiliates, as appropriate, to do so under the Clinical Trial Agreements, as directed by Buyer, including by requesting the other party or parties to such Clinical Trial Agreements to take such actions, or to not take such actions, as are permitted or required under such Clinical Trial Agreements and under applicable Laws and regulatory requirements, all as Buyer may so direct. However, Seller shall not have any duty to take such actions or fail to take such action unless such actions or failure to take such actions are consistent with Seller’s ethical practices.

 

 

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(d)    Seller shall promptly (but in no event later than [***] days after receipt of the request for reimbursement) reimburse Buyer for any amounts actually paid or accrued by Buyer to any other party or parties related to [***]; provided that Seller shall only be obligated to reimburse Buyer (i) for amounts actually paid or accrued by Buyer for [***] or (ii) for other amounts actually paid or accrued related to [***]. Buyer shall submit an invoice and reasonable supporting documentation for such reimbursable amounts to Seller no later than [***], and Seller shall reimburse Buyer for all such undisputed amounts within [***] days of receipt of such invoice.

(e)    The Parties hereby designate [***] and [***] to serve as the initial main point of contact for each Party to coordinate the Parties’ activities with respect to the transition from Seller to Buyer of the Ongoing Clinical Trials under this Agreement (such initial contacts, as may be replaced by the Parties from time to time, the “ Designated Contacts ”). The Parties intend that the Designated Contacts meet and/or correspond on a monthly basis for such purposes and as otherwise needed, including to manage the post-Closing undertakings contemplated hereby. Each Party may change its Designated Contact from time to time upon written notice to the other Party; provided that the Parties recognize and agree as to the importance of continuity in their relationship and the activities hereunder.

Section 5.8     Adverse Events . From and after the Closing, Buyer will assume all responsibility for reporting adverse events involving the Product to which Buyer becomes aware to the applicable Governmental Authority according to the transition plan and in any event in the timeframe required by Law.

ARTICLE VI

INDEMNITY

Section 6.1     Indemnification by Seller . Subject to the terms and conditions of this Article VI, from and after the Closing, Seller shall indemnify Buyer, each Affiliate of Buyer, and each of their respective stockholders, directors, officers and employees (the “ Buyer Indemnified Parties ”) from and against all Losses incurred or suffered by any of the Buyer Indemnified Parties arising from or relating to or (in the case of clause (iii)) constituting, (i)  any inaccuracy in or breach of any of the representations or warranties of Seller contained in this Agreement or any Ancillary Agreement; (ii) any breach or non-fulfillment of any covenant, agreement or obligation to be performed by Seller pursuant to this Agreement or any Ancillary Agreement; or (iii) any Excluded Liability.

Section 6.2     Indemnification by Buyer . Subject to the terms and conditions of this Article VI, from and after the Closing, Buyer shall indemnify Seller, each Affiliate of Seller, and each of their respective stockholders, directors, officers and employees (the “ Seller Indemnified Parties ”) from and against all Losses incurred or suffered by any of the Seller Indemnified Parties arising from or relating to or (in the case of clause (v)) constituting, (i) any inaccuracy in or breach of any of the representations or warranties of Buyer contained in this Agreement or any Ancillary Agreement; (ii)  any breach or non-fulfillment of any covenant, agreement or obligation to be performed by Buyer pursuant to this Agreement or any Ancillary Agreement; (iii) the portion of Transfer Taxes for which Buyer is liable under Section 2.11(a); (iv) Additional Amounts payable by Buyer pursuant to Section 2.11(b); or (v) any Assumed Liability, including Liabilities for Taxes with respect to the Purchased Assets for a Taxable period (or portion thereof) beginning after the Closing Date.

 

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Section 6.3     Claims for Indemnification .

(a)     Third Party Claims . All claims for indemnification made under this Agreement or any Ancillary Agreement arising out of or resulting from any claim, demand, action, suit or proceeding made or brought by a Third Party (a “ Third Party Claim ”) against an Indemnified Party shall be made in accordance with the following procedures.

(i)    The Buyer Indemnified Parties or Seller Indemnified Parties, as applicable (an “ Indemnified Party ”), shall give prompt written notification to the Person from whom indemnification is sought under this Article VI (the “ Indemnifying Party ”) of the commencement of any Third Party Claim for which indemnification may be sought or, if earlier, upon the receipt of any such claim or demand by a Third Party; provided , however , that the failure so to notify the Indemnifying Party promptly or at all shall not relieve the Indemnifying Party of any liability or obligation it may have to the Indemnified Party hereunder except to the extent of actual prejudice caused by such failure. Such notification shall include a description in reasonable detail (to the extent known by the Indemnified Party) of the facts constituting the basis for such Third Party Claim and the amount of the Losses claimed. Within twenty-five (25) days after delivery of such notification, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense of such Third Party Claim with counsel reasonably satisfactory to the Indemnified Party; provided , that if the Indemnifying Party is Seller, such Indemnifying Party shall not have the right to defend or direct the defense of any such Third Party Claim that (i) seeks an injunction or other equitable relief or involves a criminal act alleged against the Indemnified Party, (ii) relates to the Purchased IP or (iii) is brought by or on behalf of a Governmental Authority.

(ii)    The Party not controlling such defense may participate therein at its own expense; provided , however , that if the Indemnifying Party assumes control of such defense and the Indemnified Party reasonably concludes, based on advice from counsel, that the Indemnifying Party and the Indemnified Party have conflicting interests with respect to such Third Party Claim, the reasonable fees and expenses of counsel to the Indemnified Party solely in connection therewith shall also be considered “ Losses ” for the purposes of this Agreement; provided , further , however , that in no event shall the Indemnifying Party be responsible for the fees and expenses of more than one counsel for all Indemnified Parties. The Party controlling such defense shall keep the other Party advised of the status of such Third Party Claim and the defense thereof and shall consider recommendations made by the other Party with respect thereto.

 

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(iii)    The Indemnified Party shall not agree to any settlement of any Third Party Claim without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld, conditioned or delayed. The Indemnifying Party shall not agree to any settlement of any Third Party Claim that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto or that admits to any liability on the part of, or imposes any liability, injunction or obligation on, the Indemnified Party without the prior written consent of the Indemnified Party (other than the payment of money as to which the Indemnifying Party has acknowledged in writing its indemnification obligation hereunder and has provided the Indemnified Party with evidence reasonably satisfactory to the Indemnified Party of its ability to pay) which consent shall not be unreasonably withheld or delayed.

(b)     Procedure for Other Claims . An Indemnified Party wishing to assert a claim for indemnification under this Article VI which is not subject to Section 6.3(a) shall deliver to the Indemnifying Party a written notice (a “ Claim Notice ”), based upon the information then available to the Indemnified Party, which contains (i) a description and the amount (the “ Claimed Amount ”) of any Losses incurred by the Indemnified Party, (ii) a statement that the Indemnified Party is entitled to indemnification under this Article VI and a reasonable explanation of the basis therefor and (iii) a demand for payment in the amount of such Losses. Within thirty (30) days after delivery of a Claim Notice, the Indemnifying Party shall deliver to the Indemnified Party a written response in which the Indemnifying Party shall: (A) agree that the Indemnified Party is entitled to receive all of the Claimed Amount (in which case such response shall be accompanied by a payment by the Indemnifying Party to the Indemnified Party of the Claimed Amount, by check or by wire transfer), (B) agree that the Indemnified Party is entitled to receive part, but not all, of the Claimed Amount (the “ Agreed Amount ”) (in which case such response shall be accompanied by a payment by the Indemnifying Party to the Indemnified Party of the Agreed Amount, by check or by wire transfer), or (C) contest that the Indemnified Party is entitled to receive any of the Claimed Amount. If the Indemnifying Party in such response contests the payment of all or part of the Claimed Amount, the Indemnifying Party and the Indemnified Party shall use good faith efforts to resolve such dispute.

Section 6.4     Survival .

(a)    The representations and warranties of Seller and Buyer set forth in Article III and Article IV of this Agreement, or in any Ancillary Agreement, shall survive the Closing and the consummation of the transactions contemplated hereby and continue until the date that is [***] months after the Closing Date, at which time they shall (except as set forth in Section 6.4(b)) expire. All covenants, agreements and undertakings of the Parties contemplating performance after the Closing Date shall survive the Closing Date in accordance with their terms, subject to the expiration of the applicable statute of limitations for any claim relating thereto.

(b)    No claim for indemnification may be made based on a representation or warranty after the expiration thereof as provided in Section 6.4(a); provided , however , that if an indemnification claim under Section 6.1(i) or Section 6.2(i) is properly asserted in writing pursuant to Section 6.3 prior to the expiration as provided in Section 6.4(a) of the representation or warranty that is the basis for such claim, then such representation or warranty shall survive until, but only for the purpose of, the resolution of such claim.

 

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*** Confidential Treatment Requested.


Section 6.5     Limitations .

(a)    Notwithstanding anything to the contrary contained in this Agreement, the following limitations shall apply to indemnification claims under this Agreement:

 

  (i)

Seller, on the one hand, or Buyer, on the other hand, shall be liable with respect to claims under Section 6.1(i) or Section 6.2(i), respectively, only if the aggregate Losses related to such claims, when considered together, exceeds [***] (the “ Threshold ”) in which case Seller or Buyer, as applicable, shall be liable for the amount of all Losses (including amounts up to the Threshold), subject to the limitations set forth in this Agreement.

 

  (ii)

Notwithstanding the foregoing, the aggregate liability of Seller for Losses paid with respect to the indemnification described in Section 6.1(i) shall not exceed [***] (the “ Seller Indemnification Cap ”); provided , however , that the Seller Indemnification Cap shall not apply with respect to any Losses arising from fraud.

 

  (iii)

Notwithstanding the foregoing, the aggregate liability of Buyer for Losses paid with respect to the indemnification described in this Section 6.2(i) shall not exceed [***] (the “ Buyer Indemnification Cap ”); provided , however , that the Buyer Indemnification Cap shall not apply with respect to any Losses arising from fraud.

(b)    The amount of Losses recoverable by an Indemnified Party under this Article VI with respect to an indemnity claim shall be reduced by the amount of any payment received by such Indemnified Party (or an Affiliate thereof), with respect to the Losses to which such indemnity claim relates, from an insurance carrier. The Parties shall cooperate with each other in pursuing insurance claims with respect to any Losses or any indemnification obligations with respect to Losses. If an Indemnified Party (or an Affiliate thereof) receives any insurance payment in connection with any claim for Losses for which it has already received an indemnification payment from the Indemnifying Party, it shall pay to the Indemnifying Party, within thirty (30) days of receiving such insurance payment, an amount equal to the excess of (A) the amount previously received by the Indemnified Party under this Article VI with respect to such claim plus the amount of the insurance payments received, over (B) the amount of Losses with respect to such claim which the Indemnified Party was or has become entitled to receive under this Article VI and the costs associated with obtaining such insurance payment, including the cost of any increased premiums.

(c)    Except for claims for equitable relief (including specific performance) made with respect to breaches of any covenant or agreement contained in this Agreement or the Ancillary Agreements, the rights of the Indemnified Parties under this Article VI shall be the sole and exclusive remedies of the Indemnified Parties and their respective Affiliates with respect to claims covered by Section 6.1 or Section 6.2 or otherwise arising out of, resulting from or relating to this Agreement (including any exhibits or schedules hereto), any Ancillary Agreement (including any exhibits or schedules thereto) or any certificates or other instruments delivered in connection with this Agreement or any Ancillary Agreement, or any of the transactions contemplated hereby or thereby.

 

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*** Confidential Treatment Requested.


(d)    Notwithstanding anything to the contrary contained in this Agreement, in the event that the Buyer Indemnified Parties are entitled to indemnification pursuant to this Article VI, Buyer shall have the right, but shall not be obligated to, set off, against any Milestone Payment or Royalties to Seller pursuant to Section 2.9 or Section 2.10, respectively, any amounts to which the Buyer Indemnified Parties are entitled to indemnification pursuant to, and subject to the limitations set forth in, this Article VI, applying such amounts in satisfaction, to the extent of such amount, of such owed amounts; provided that any set off pursuant to this Section 6.5(d) shall only be permitted in respect of an amount finally determined to be owed by the Indemnifying Party to a Buyer Indemnified Party pursuant to a final non-appealable order or judgment by a court of competent jurisdiction.

Section 6.6     Tax Treatment of Indemnification Payments . Unless otherwise required by applicable Law, all indemnification payments made under this Agreement shall be treated by the Parties as an adjustment to the Closing Consideration. For the avoidance of doubt, proper adjustments shall be made to the Allocation Schedule with respect to any indemnification payments pursuant to this Article VI.

ARTICLE VII

MISCELLANEOUS

Section 7.1     GSI Guarantee . GSI hereby agrees to guarantee the obligations of Seller pursuant to this Agreement and, as described below, to transfer Purchased Assets held in its name on behalf of Seller, and GSI is a signatory of this Agreement solely for such purposes. Whenever this Agreement requires Seller to take any action, such requirement shall be deemed to include an undertaking on the part of GSI to cause Seller to take such action and a guarantee of performance thereof. GSI hereby agrees to directly assign, convey and deliver to Buyer the Purchased Assets listed on Schedule 2.3(b)(i) and specifically identified therein as GSI’s obligation. GSI further agrees to be directly bound by and comply with the provisions related to interpretation and enforcement of this Agreement as set forth herein, which are hereby incorporated in this Section 7.1 by reference as fully as if set forth herein in their entirety.

Section 7.2     Interpretation . In this Agreement unless otherwise specified:

(a)    “ includes ” and “ including ” shall mean respectively includes and including without limitation;

(b)    a Party includes its permitted assignees and/or the respective successors in title to substantially the whole of its undertaking;

(c)    words denoting the singular shall include the plural and vice versa and words denoting any gender shall include all genders;

(d)    references to Sections and Schedules are to Sections and Schedules of this Agreement unless otherwise specified;

 

 

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(e)    the headings in this Agreement are for information only and shall not be considered in the interpretation of this Agreement;

(f)    the words “hereof”, “herein” and “hereunder” and words of like import used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement;

(g)    references to any agreement or contract are to that agreement or contract as amended, modified or supplemented from time to time in accordance with the terms hereof and thereof; provided that with respect to any agreement or contract listed on any Schedules hereto, all such amendments, modifications or supplements in existence on the date hereof must also be listed in the appropriate Schedule; and

(h)    the Parties agree that the terms and conditions of this Agreement are the result of negotiations between the Parties and that this Agreement shall not be construed in favor of or against any Party by reason of the extent to which any Party participated in its preparation.

Section 7.3     Currency . All currency amounts referred to in this Agreement are in U.S. Dollars unless otherwise specified.

Section 7.4     Entire Agreement; Third Party Beneficiaries . This Agreement (together with all Exhibits, Schedules and disclosure schedules attached hereto and other documents and instruments referred to herein that are to be delivered at the Closing) and the Ancillary Agreements, (a) constitute the entire agreement among the parties to this Agreement and supersede all other prior agreements and understandings, both written and oral, among the Parties with respect to the subject matter hereof, and (b) is not intended to confer upon any Person other than the Parties hereto any rights or remedies.

Section 7.5     Notices . All notices and other communications hereunder shall be in writing and shall be deemed duly delivered (i) one (1) Business Day after being sent for next Business Day delivery, fees prepaid, via a reputable nationwide overnight courier service or (ii) on the date of confirmation of receipt of transmission by facsimile, in each case to the intended recipient as set forth below:

(a)    If to Buyer, to:

Sierra Oncology, Inc.

2150-885 W Georgia Street

Vancouver, BC V6C 3E8

Attn: Chief Financial Officer

Facsimile No.:    

(b)    if to Seller or GSI, to:

Gilead Sciences, Inc.

333 Lakeside Drive

Foster City, CA 94404

Attention: General Counsel

Facsimile No.:     (650) 522-5771

 

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Any Party to this Agreement may give any notice or other communication hereunder using any other means (including personal delivery, messenger service, or ordinary mail), but no such notice or other communication shall be deemed to have been duly given unless and until it actually is received by the Party for whom it is intended. Any Party to this Agreement may change the address to which notices and other communications hereunder are to be delivered by giving the other Parties to this Agreement notice in the manner herein set forth.

Section 7.6     No Waiver . No waiver by any Party hereto of any breach of any covenant, agreement, representation or warranty hereunder shall be deemed a waiver of any preceding or succeeding breach of the same. The exercise of any right granted to any Party herein shall not operate as a waiver of any default or breach on the part of the other Party hereto. Each and all of the several rights and remedies of any Party hereto under this Agreement shall be construed as cumulative and no one right as exclusive of the others.

Section 7.7     Amendments . No change, modification, alteration, amendment or agreement to discharge in whole or in part, or waiver of, any of the terms and conditions of this Agreement, shall be binding upon any Party, unless the same shall be made by a written instrument signed and executed by the authorized representatives of each Party.

Section 7.8     Specific Performance . The Parties agree that if for any reason any of the provisions of this Agreement are not performed in accordance with their specific terms or are otherwise breached, immediate and irreparable harm or injury would be caused for which money damages would not be an adequate remedy. Accordingly, each Party agrees that, in addition to any other available remedy at law or equity, each Party shall be entitled to an injunction restraining any violation or threatened violation of the provisions of this Agreement without the necessity of posting a bond or other form of security. In the event that any Action should be brought in equity to enforce the provisions of this Agreement, no Party will allege, and each Party hereby waives the defense, that there is an adequate remedy at law.

Section 7.9     Governing Law . This Agreement and all claims and Actions arising from or relating to this Agreement shall be governed by and construed and enforced in accordance with the laws of the State of Delaware without reference to such State’s principles of conflict of laws.

Section 7.10     Jurisdiction; Venue; Consent to Service of Process . Each of the Parties hereto (a) consents to submit itself to the exclusive personal jurisdiction of the Delaware Chancery Court and any Federal court located in the State of Delaware in the event of any Action arising out of or relating to this Agreement or any of the transactions contemplated by this Agreement, (b) agrees that it will not attempt to deny or defeat such personal jurisdiction by motion or other request for leave from any such court and (c) agrees that it will not bring any Action arising out of or relating to this Agreement or any of the transactions contemplated by this Agreement in any court other than the Delaware Chancery Court or a Federal court sitting in the State of Delaware. In any Action arising out of or relating to this Agreement or any of the transactions contemplated by this Agreement, each Party irrevocably and unconditionally waives

 

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and agrees not to assert by way of motion, as a defense or otherwise any claims that it is not subject to the jurisdiction of the above courts, that such Action is brought in an inconvenient forum or that the venue of such Action is improper. Each of the Parties also hereby agrees that any final and unappealable judgment against a Party in connection with any such Action shall be conclusive and binding on such Party and that such award or judgment may be enforced in any court of competent jurisdiction, either within or outside of the United States. A certified or exemplified copy of such judgment shall be conclusive evidence of the fact and amount of such judgment. Each Party hereto irrevocably consents to service of process in the manner provided for the giving of notices pursuant to this Agreement. Nothing in this Section 7.10 shall affect the right of any Party to serve process in any other manner permitted by applicable Law.

Section 7.11     Waiver of Jury Trial . To the fullest extent permitted by Law, each of the Parties irrevocably waives all right to trial by jury in any Action or counterclaim arising out of or relating to this Agreement or any of the transactions contemplated by this Agreement.

Section 7.12     Assignment; Successors and Assigns . No Party may assign, delegate or otherwise transfer any of its rights or obligations under this Agreement without the consent of the other Party hereto; provided , however , that following the Closing, either Party may assign (a) any of its rights and obligations hereunder to any of its Affiliates for so long as such Affiliates remain Affiliates of such Party, (b) all of its rights and obligations hereunder to its successor in interest in connection with the transfer or sale of all or substantially all of its stock or assets, or in connection with a merger, consolidation, change in control or similar transaction and (c) in the case of Seller, its right to receive payments hereunder, including Milestone Payments and Royalties, and all related rights and obligations to any Affiliate or Third Party, in each case, without the consent of the other Party. Any attempted assignment in violation of the foregoing shall be null and void. This Agreement shall inure to the benefit of and be binding upon the respective successors and assigns of the Parties hereto, but any such assignment by any Party hereto shall not relieve such assigning Party of any of its obligations or agreements hereunder unless expressly agreed to in writing by each other Party hereto in its sole discretion.

Section 7.13     Severability . If any term or other provision of this Agreement is determined by a court of competent jurisdiction to be invalid, illegal or incapable of being enforced, all other terms and provisions of this Agreement shall nevertheless remain in full force and effect. Upon such determination that any term or other provision is invalid, illegal or incapable of being enforced, the Parties hereto shall negotiate in good faith to modify this Agreement so as to effect the original intent of the Parties as closely as possible in a mutually acceptable manner.

Section 7.14     Counterparts . This Agreement may be executed simultaneously in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.

[signature page follows]

 

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be signed by their respective representatives thereunto duly authorized, all as of the date first written above.

 

YM BIOSCIENCES AUSTRALIA PTY LTD
By:   /s/ Robin L. Washington
 

Name: Robin L. Washington

Title:   Director

 

SIERRA ONCOLOGY, INC.
By:   /s/ Nick Glover
 

Name: Nick Glover

Title:   President and Chief Executive Officer

 

GILEAD SCIENCES, INC. (Solely For Purposes of Section 7.1)
By:   /s/ Robin L. Washington
 

Name: Robin L. Washington

Title:   Executive Vice President and

            Chief Financial Officer

Exhibit 4.1

THIS WARRANT AND THE SHARES ISSUABLE HEREUNDER HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR THE SECURITIES LAWS OF ANY STATE AND, EXCEPT AS SET FORTH IN SECTIONS 5.3 AND 5.4 BELOW, MAY NOT BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED UNLESS AND UNTIL REGISTERED UNDER SAID ACT AND LAWS OR IN FORM AND SUBSTANCE SATISFACTORY TO THE COMPANY, SUCH OFFER, SALE, PLEDGE OR OTHER TRANSFER IS EXEMPT FROM SUCH REGISTRATION.

WARRANT TO PURCHASE COMMON STOCK

Company: SIERRA ONCOLOGY, INC., a Delaware corporation

Number of Shares of Common Stock: 73,529 (the “Initial Shares”, plus all Additional Shares (as defined in Section 1.7) which Holder is entitled to purchase

Warrant Price: $1.87 per share

Issue Date: August 21, 2018

Expiration Date: August 21, 2028 See also Section 5.1(b).

 

Credit Facility:    This Warrant to Purchase Common Stock (“ Warrant ”) is issued in connection with that certain Loan and Security Agreement of even date herewith between Silicon Valley Bank and the Company (the “ Loan Agreement ”).

THIS WARRANT CERTIFIES THAT, for good and valuable consideration, SILICON VALLEY BANK (together with any successor or permitted assignee or transferee of this Warrant or of any shares issued upon exercise hereof, “ Holder ”) is entitled to purchase the number of fully paid and non-assessable shares (the “ Shares ”) of the above-stated common stock (the “ Common Stock ”) of the above-named company (the “ Company ”) at the above-stated Warrant Price, all as set forth above and as adjusted pursuant to Section 2 of this Warrant, subject to the provisions and upon the terms and conditions set forth in this Warrant. Reference is made to Section 5.4 of this Warrant whereby Silicon Valley Bank shall transfer this Warrant to its parent company, SVB Financial Group.

SECTION 1. EXERCISE.

1.1 Method of Exercise . Holder may at any time and from time to time exercise this Warrant, in whole or in part, by delivering to the Company the original of this Warrant together with a duly executed Notice of Exercise in substantially the form attached hereto as Appendix 1 and, unless Holder is exercising this Warrant pursuant to a cashless exercise set forth in Section 1.2, a check, wire transfer of same-day funds (to an account designated by the Company), or other form of payment acceptable to the Company for the aggregate Warrant Price for the Shares being purchased.

1.2 Cashless Exercise . On any exercise of this Warrant, in lieu of payment of the aggregate Warrant Price in the manner as specified in Section 1.1 above, but otherwise in accordance with the requirements of Section 1.1, Holder may elect to receive Shares equal to the value of this Warrant, or portion hereof as to which this Warrant is being exercised. Thereupon, the Company shall issue to the Holder such number of fully paid and non-assessable Shares as are computed using the following formula:

X = Y(A-B)/A

 

1


where:

     
   X =    the number of Shares to be issued to the Holder;
   Y =    the number of Shares with respect to which this Warrant is being exercised (inclusive of the Shares surrendered to the Company in payment of the aggregate Warrant Price);
   A =    the Fair Market Value (as determined pursuant to Section 1.3 below) of one Share; and
   B =    the Warrant Price.

1.3 Fair Market Value . If the Company’s Common Stock is then traded or quoted on a nationally recognized securities exchange, inter-dealer quotation system or over-the-counter market (a “ Trading Market ”), the fair market value of a Share shall be the closing price or last sale price of a share of Common Stock reported for the Business Day immediately before the date on which Holder delivers this Warrant together with its Notice of Exercise to the Company. If the Company’s Common Stock is not traded in a Trading Market, the Board of Directors of the Company shall determine the fair market value of a Share in its reasonable good faith judgment.

1.4 Delivery of Certificate and New Warrant . Within a reasonable time after Holder exercises this Warrant in the manner set forth in Section 1.1 or 1.2 above, the Company shall deliver to Holder a certificate (or credit such holder’s account with The Depository Trust Company through its Deposit or Withdrawal at Custodian system (“ DWAC ”)) representing the Shares issued to Holder upon such exercise and, if this Warrant has not been fully exercised and has not expired, a new warrant of like tenor representing the Shares not so acquired.

1.5 Replacement of Warrant . On receipt of evidence reasonably satisfactory to the Company of the loss, theft, destruction or mutilation of this Warrant and, in the case of loss, theft or destruction, on delivery of an indemnity agreement reasonably satisfactory in form, substance and amount to the Company or, in the case of mutilation, on surrender of this Warrant to the Company for cancellation, the Company shall, within a reasonable time, execute and deliver to Holder, in lieu of this Warrant, a new warrant of like tenor and amount.

1.6 Treatment of Warrant Upon Acquisition of Company .

(a) Acquisition . For the purpose of this Warrant, “ Acquisition ” means any transaction or series of related transactions involving: (i) the sale, lease, exclusive license, or other disposition of all or substantially all of the assets of the Company; (ii) any merger or consolidation of the Company into or with another person or entity (other than a merger or consolidation effected exclusively to change the Company’s domicile), or any other corporate reorganization, in which the stockholders of the Company in their capacity as such immediately prior to such merger, consolidation or reorganization, own less than a majority of the Company’s (or the surviving or successor entity’s) outstanding voting power immediately after such merger, consolidation or reorganization; or (iii) any sale or other transfer by the stockholders of the Company of shares representing at least a majority of the Company’s then-total outstanding combined voting power.

 

2


(b) Treatment of Warrant at Acquisition . In the event of an Acquisition in which the consideration to be received by the Company’s stockholders consists solely of cash, solely of Marketable Securities or a combination of cash and Marketable Securities (a “ Cash/Public Acquisition ”), and the fair market value of one Share as determined in accordance with Section 1.3 above would be greater than the Warrant Price in effect on such date immediately prior to such Cash/Public Acquisition, and Holder has not exercised this Warrant pursuant to Section 1.1 above as to all Shares, then this Warrant shall automatically be deemed to be Cashless Exercised pursuant to Section 1.2 above as to all Shares effective immediately prior to and contingent upon the consummation of a Cash/Public Acquisition. In connection with such Cashless Exercise, Holder shall be deemed to have restated each of the representations and warranties in Section 4 of the Warrant as the date thereof and the Company shall promptly notify the Holder of the number of Shares (or such other securities) issued upon exercise. In the event of a Cash/Public Acquisition where the fair market value of one Share as determined in accordance with Section 1.3 above would be less than the Warrant Price in effect immediately prior to such Cash/Public Acquisition, then this Warrant will expire immediately prior to the consummation of such Cash/Public Acquisition.

(c) Upon the closing of any Acquisition other than a Cash/Public Acquisition defined above, the acquiring, surviving or successor entity shall assume the obligations of this Warrant, and this Warrant shall thereafter be exercisable for the same securities and/or other property as would have been paid for the Shares issuable upon exercise of the unexercised portion of this Warrant as if such Shares were outstanding on and as of the closing of such Acquisition, subject to further adjustment from time to time in accordance with the provisions of this Warrant.

(d) As used in this Warrant, “ Marketable Securities ” means securities meeting all of the following requirements: (i) the issuer thereof is then subject to the reporting requirements of Section 13 or Section 15(d) of the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”), and is then current in its filing of all required reports and other information under the Act and the Exchange Act; (ii) the class and series of shares or other security of the issuer that would be received by Holder in connection with the Acquisition were Holder to exercise this Warrant on or prior to the closing thereof is then traded in Trading Market, and (iii) following the closing of such Acquisition, Holder would not be restricted from publicly re-selling all of the issuer’s shares and/or other securities that would be received by Holder in such Acquisition were Holder to exercise or convert this Warrant in full on or prior to the closing of such Acquisition, except to the extent that any such restriction (x) arises solely under federal or state securities laws, rules or regulations, and (y) does not extend beyond six (6) months from the closing of such Acquisition.

 

3


1.7 Number of Shares . The number of Shares for which this Warrant shall be exercisable shall be equal to (i) the Initial Shares, plus , (ii) upon the making by Silicon Valley Bank to the Company of each Tranche B Growth Capital Advance (as defined in the Loan Agreement), the Tranche B Additional Shares (as defined below), plus (iii) upon the making by Silicon Valley Bank to the Company of each Tranche C Growth Capital Advance (as defined in the Loan Agreement), the Tranche C Additional Shares (as defined below and together with the Tranche B Additional Shares, the “ Additional Shares ”). As used herein, the “ Tranche B Additional Shares ” means a number of Shares equal to the quotient of (a) the product obtained by multiplying (I) the aggregate principal amount of each Tranche B Growth Capital Advance made by Silicon Valley bank to the Company, by (II) 2.75%, divided by (b) the Warrant Price. As used herein, the “ Tranche C Additional Shares ” means a number of Shares equal to the quotient of (a) the product obtained by multiplying (I) the aggregate principal amount of each Tranche C Growth Capital Advance made by Silicon Valley Bank to the Company, by (II) 2.75%, divided by (b) the Warrant Price. For clarity, the total number of Shares for which this Warrant shall be exercisable shall be 220,588 if the Growth Capital Line (as defined in the Loan Agreement) is fully drawn.

SECTION 2. ADJUSTMENTS TO THE SHARES AND WARRANT PRICE.

2.1 Stock Dividends, Splits, Etc . If the Company declares or pays a dividend or distribution on the outstanding shares of the Common Stock payable in securities or property (other than cash), then upon exercise of this Warrant, for each Share acquired, Holder shall receive, without additional cost to Holder, the total number and kind of securities and property which Holder would have received had Holder owned the Shares of record as of the date the dividend or distribution occurred. If the Company subdivides the outstanding shares of the Common Stock by reclassification or otherwise into a greater number of shares, the number of Shares purchasable hereunder shall be proportionately increased and the Warrant Price shall be proportionately decreased. If the outstanding shares of the Common Stock are combined or consolidated, by reclassification or otherwise, into a lesser number of shares, the Warrant Price shall be proportionately increased and the number of Shares shall be proportionately decreased.

2.2 Reclassification, Exchange, Combinations or Substitution . Upon any event whereby all of the outstanding shares of the Common Stock are reclassified, exchanged, combined, substituted, or replaced for, into, with or by Company securities of a different class and/or series, then from and after the consummation of such event, this Warrant will be exercisable for the number, class and series of Company securities that Holder would have received had the Shares been outstanding on and as of the consummation of such event, and subject to further adjustment thereafter from time to time in accordance with the provisions of this Warrant. The provisions of this Section 2.2 shall similarly apply to successive reclassifications, exchanges, combinations substitutions, replacements or other similar events.

2.3 Intentionally Omitted .

2.4 Intentionally Omitted .

2.5 No Fractional Share . No fractional Share shall be issuable upon exercise of this Warrant and the number of Shares to be issued shall be rounded up to the nearest whole Share.

 

4


2.6 Notice/Certificate as to Adjustments . Upon each adjustment of the Warrant Price, Common Stock and/or number of Shares, the Company, at the Company’s expense, shall notify Holder in writing within a reasonable time setting forth the adjustments to the Warrant Price, class and/or number of Shares and facts upon which such adjustment is based. The Company shall, upon written request from Holder, furnish Holder the computations related to such adjustment.

SECTION 3. REPRESENTATIONS AND COVENANTS OF THE COMPANY.

3.1 Representations and Warranties . The Company represents and warrants to, and agrees with, the Holder that all Shares which may be issued upon the exercise of this Warrant, shall, upon issuance, be duly authorized, validly issued, fully paid and non-assessable, and free of any liens and encumbrances except for restrictions on transfer provided for herein or under applicable federal and state securities laws. The Company covenants that it shall at all times cause to be reserved and kept available out of its authorized and unissued capital stock such number of securities as will be sufficient to permit the exercise in full of this Warrant.

3.2 Notice of Certain Events . If the Company proposes at any time to:

(a) declare any dividend or distribution upon the outstanding shares of the Company’s stock, whether in cash, property, stock, or other securities and whether or not a regular cash dividend;

(b) offer for subscription or sale pro rata to the holders of the outstanding shares any additional shares of any class or series of the Company’s stock (other than pursuant to contractual pre-emptive rights);

(c) effect any reclassification, exchange, combination, substitution, reorganization or recapitalization of the outstanding shares of the Common Stock; or

(d) effect an Acquisition or to liquidate, dissolve or wind up;

then, in connection with each such event, the Company shall give Holder:

(1) in the case of the matters referred to in (a) and (b) above, at least seven (7) Business Days prior written notice of the earlier to occur of the effective date thereof or the date on which a record will be taken for such dividend, distribution, or subscription rights (and specifying the date on which the holders of outstanding shares of the Common Stock will be entitled thereto) or for determining rights to vote, if any; and

(2) in the case of the matters referred to in (c) and (d) above at least seven (7) Business Days prior written notice of the date when the same will take place (and specifying the date on which the holders of outstanding shares of the Common Stock will be entitled to exchange their shares for the securities or other property deliverable upon the occurrence of such event and such reasonable information as Holder may reasonably require regarding the treatment of this Warrant in connection with such event giving rise to the notice).

 

5


Company will also provide information requested by Holder that is reasonably necessary to enable Holder to comply with Holder’s accounting or reporting requirements.

SECTION 4. REPRESENTATIONS, WARRANTIES OF THE HOLDER.

The Holder represents and warrants to the Company as follows:

4.1 Purchase for Own Account . This Warrant and the Shares to be acquired upon exercise of this Warrant by Holder are being acquired for investment for Holder’s account, not as a nominee or agent, and not with a view to the public resale or distribution within the meaning of the Act. Holder also represents that it has not been formed for the specific purpose of acquiring this Warrant or the Shares.

4.2 Disclosure of Information . Holder is aware of the Company’s business affairs and financial condition and has received or has had full access to all the information it considers necessary or appropriate to make an informed investment decision with respect to the acquisition of this Warrant and its underlying securities. Holder further has had an opportunity to ask questions and receive answers from the Company regarding the terms and conditions of the offering of this Warrant and its underlying securities and to obtain additional information (to the extent the Company possessed such information or could acquire it without unreasonable effort or expense) necessary to verify any information furnished to Holder or to which Holder has access.

4.3 Investment Experience . Holder understands that the purchase of this Warrant and its underlying securities involves substantial risk. Holder has experience as an investor in securities of companies in the development stage and acknowledges that Holder can bear the economic risk of such Holder’s investment in this Warrant and its underlying securities and has such knowledge and experience in financial or business matters that Holder is capable of evaluating the merits and risks of its investment in this Warrant and its underlying securities and/or has a preexisting personal or business relationship with the Company and certain of its officers, directors or controlling persons of a nature and duration that enables Holder to be aware of the character, business acumen and financial circumstances of such persons.

4.4 Accredited Investor Status . Holder is an “accredited investor” within the meaning of Regulation D promulgated under the Act.

4.5 No Voting Rights . Holder, as a Holder of this Warrant, will not have any voting rights until the exercise of this Warrant.

 

6


SECTION 5. MISCELLANEOUS.

5.1 Term and Automatic Conversion Upon Expiration .

(a) Term . Subject to the provisions of Section 1.6 above, this Warrant is exercisable in whole or in part at any time and from time to time on or before 5:00 PM, Pacific time, on the Expiration Date and shall be void thereafter.

(b) Automatic Cashless Exercise upon Expiration . In the event that, upon the Expiration Date, the fair market value of one Share (or other security issuable upon the exercise hereof) as determined in accordance with Section 1.3 above is greater than the Warrant Price in effect on such date, then this Warrant shall automatically be deemed on and as of such date to be exercised pursuant to Section 1.2 above as to all Shares (or such other securities) for which it shall not previously have been exercised, and the Company shall, within a reasonable time, deliver a certificate (or credit such holder’s account with The Depository Trust Company through its DWAC system) representing the Shares (or such other securities) issued upon such exercise to Holder.

5.2 Compliance with Securities Laws on Transfer . This Warrant and the Shares issuable upon exercise of this Warrant (and the securities issuable, directly or indirectly, upon conversion of the Shares, if any) may not be transferred or assigned in whole or in part except in compliance with applicable federal and state securities laws by the transferor and the transferee (including, without limitation, the delivery of investment representation letters and legal opinions reasonably satisfactory to the Company, as reasonably requested by the Company).

5.3 Transfer Procedure . After receipt by Silicon Valley Bank of the executed Warrant, Silicon Valley Bank will transfer all of this Warrant to its parent company, SVB Financial Group. By its acceptance of this Warrant, SVB Financial Group hereby makes to the Company each of the representations and warranties set forth in Section 4 hereof and agrees to be bound by all of the terms and conditions of this Warrant as if the original Holder hereof. Subject to the provisions of Section 5.3 and upon providing the Company with written notice, SVB Financial Group and any subsequent Holder may transfer all or part of this Warrant or the Shares issuable upon exercise of this Warrant (or the securities issuable directly or indirectly, upon conversion of the Shares, if any) to any transferee, provided, however, in connection with any such transfer, SVB Financial Group or any subsequent Holder will give the Company notice of the portion of the Warrant being transferred with the name, address and taxpayer identification number of the transferee and Holder will surrender this Warrant to the Company for reissuance to the transferee(s) (and Holder if applicable); and provided further, that any subsequent transferee other than SVB Financial Group shall agree in writing with the Company to be bound by all of the terms and conditions of this Warrant.

5.4 Notices . All notices and other communications hereunder from the Company to the Holder, or vice versa, shall be deemed delivered and effective (i) when given personally, (ii) on the third (3rd) Business Day after being mailed by first-class registered or certified mail, postage prepaid, (iii) upon actual receipt if given by facsimile or electronic mail and such receipt is confirmed in writing by the recipient, or (iv) on the first Business Day

 

7


following delivery to a reliable overnight courier service, courier fee prepaid, in any case at such address as may have been furnished to the Company or Holder, as the case may be, in writing by the Company or such Holder from time to time in accordance with the provisions of this Section 5.5. All notices to Holder shall be addressed as follows until the Company receives notice of a change of address in connection with a transfer or otherwise:

SVB Financial Group

Attn: Treasury Department

3003 Tasman Drive, HC 215

Santa Clara, CA 95054

Telephone: (408) 654-7400

Facsimile: (408) 988-8317

Email address: derivatives@svb.com

Notice to the Company shall be addressed as follows until Holder receives notice of a change in address:

SIERRA ONCOLOGY, INC.

Attn: Sukhi Jagpal, CFO

885 West Georgia Street, Suite 2150

Vancouver, BC V6C 3E8, Canada

Telephone:                                     

Email:                                     

5.5 Waiver . This Warrant and any term hereof may be changed, waived, discharged or terminated (either generally or in a particular instance and either retroactively or prospectively) only by an instrument in writing signed by the party against which enforcement of such change, waiver, discharge or termination is sought.

5.6 Attorney’s Fees . In the event of any dispute between the parties concerning the terms and provisions of this Warrant, the party prevailing in such dispute shall be entitled to collect from the other party all costs incurred in such dispute, including reasonable attorneys’ fees.

5.7 Counterparts; Facsimile/Electronic Signatures . This Warrant may be executed in counterparts, all of which together shall constitute one and the same agreement. Any signature page delivered electronically or by facsimile shall be binding to the same extent as an original signature page with regards to any agreement subject to the terms hereof or any amendment thereto.

5.8 Governing Law . This Warrant shall be governed by and construed in accordance with the laws of the State of California, without giving effect to its principles regarding conflicts of law.

5.9 Headings . The headings in this Warrant are for purposes of reference only and shall not limit or otherwise affect the meaning of any provision of this Warrant.

 

8


5.10 Business Days . “ Business Day ” is any day that is not a Saturday, Sunday or a day on which Silicon Valley Bank is closed.

[ Balance of Page Intentionally Left Blank ]

 

9


IN WITNESS WHEREOF, the parties have caused this Warrant to Purchase Common Stock to be executed by their duly authorized representatives effective as of the Issue Date written above.

“COMPANY”

 

SIERRA ONCOLOGY, INC.
By:   /s/ Nick Glover
Name:   Nick Glover
Title:   CEO and President

“HOLDER”

 

SILICON VALLEY BANK
By:   /s/ Peter Sletteland
Name:   Peter Sletteland
Title:   Vice President

[ Signature Page to Warrant to Purchase Common Stock ]


APPENDIX 1

NOTICE OF EXERCISE

1. The undersigned Holder hereby exercises its right purchase                      shares of the Common Stock of SIERRA ONCOLOGY, INC. (the “ Company ”) in accordance with the attached Warrant To Purchase Common Stock, and tenders payment of the aggregate Warrant Price for such shares as follows:

[    ] check in the amount of $                  payable to order of the Company enclosed herewith

[    ] Wire transfer of immediately available funds to the Company’s account

[    ] Cashless Exercise pursuant to Section 1.2 of the Warrant

[    ] Other [Describe]                                                                                                   

2. Please issue a certificate or certificates representing the Shares in the name specified below:

 

       
   Holder’s Name   
       
       
   (Address)   

3. By its execution below and for the benefit of the Company, Holder hereby restates each of the representations and warranties in Section 4 of the Warrant to Purchase Common Stock as of the date hereof.

 

HOLDER:
 
By:    
Name:    
Title:    
(Date):    

EXHIBIT 10.1

 

     [***]    Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

LOAN AND SECURITY AGREEMENT

THIS LOAN AND SECURITY AGREEMENT (this “ Agreement ”) dated and effective as of August 21, 2018 (the “ Effective Date ”), by and between SILICON VALLEY BANK , a California corporation (“ Bank ”), and SIERRA ONCOLOGY, INC. , a Delaware corporation (“ Borrower ”), provides the terms on which Bank shall lend to Borrower and Borrower shall repay Bank. The parties agree as follows:

 

  1

ACCOUNTING AND OTHER TERMS

Accounting terms not defined in this Agreement shall be construed following GAAP. Calculations and determinations must be made following GAAP. Capitalized terms not otherwise defined in this Agreement shall have the meanings set forth in Section 13. All other terms contained in this Agreement, unless otherwise indicated, shall have the meaning provided by the Code to the extent such terms are defined therein.

 

  2

LOAN AND TERMS OF PAYMENT

2.1 Promise to Pay . Borrower hereby unconditionally promises to pay Bank the outstanding principal amount of all Credit Extensions and accrued and unpaid interest thereon as and when due in accordance with this Agreement.

2.1.1 Growth Capital Advances .

(a) Availability . Subject to the terms and conditions of this Agreement, Bank agrees to make Growth Capital Advances to Borrower from time to time in three (3) tranches: “ Tranche A ”, “ Tranche B ”, and “ Tranche C ”. On the Effective Date, or as soon thereafter as all conditions precedent to the making thereof have been met, Bank shall make a Growth Capital Advance under Tranche A, in an aggregate principal amount equal to Five Million Dollars ($5,000,000) (the “ Tranche A Growth Capital Advance ”). During the Tranche B Draw Period, Borrower may request and Bank shall make Growth Capital Advances under Tranche B, in an aggregate principal amount not to exceed Five Million Dollars ($5,000,000) (the “ Tranche B Growth Capital Advances ”). During the Tranche C Draw Period, Borrower may request and Bank shall make Growth Capital Advances under Tranche C, in an aggregate principal amount not to exceed Five Million Dollars ($5,000,000) (the “ Tranche C Growth Capital Advances ” and together with the Tranche A Growth Capital Advance and the Tranche B Growth Capital Advances, each a “ Growth Capital Advance ” and collectively, the “ Growth Capital Advances ”). Each Growth Capital Advance shall be in minimum amounts of at least One Million Dollars ($1,000,000). The aggregate outstanding amount of the Growth Capital Advances shall not, at any time, exceed the Growth Capital Line.

(b) Repayment . The Growth Capital Advances shall be “interest-only” during the Interest-Only Period, with interest due and payable in accordance with Section 2.3(d) hereof. Thereafter, the Growth Capital Advances shall be payable in equal monthly installments of principal plus accrued and unpaid interest (each a “ Growth Capital Advance Payment ”) beginning on the Amortization Start Date and continuing on the first (1 st ) day of each month thereafter. Borrower’s final Growth Capital Advance Payment, due on the Growth Capital Maturity Date, shall include all outstanding principal and accrued and unpaid interest on the Growth Capital Advances together with the Final Payment and any other amounts owing from Borrower to Bank in accordance with the Growth Capital Advances. After repayment, no Growth Capital Advance may be reborrowed.

(c) Prepayment.

 

 

*** Confidential Treatment Requested.


(i) Voluntary Prepayment . Borrower shall have the option to prepay all, but not less than all, of the Growth Capital Advances advanced by Bank under this Agreement, provided Borrower (A) delivers written notice to Bank of its election to prepay such Growth Capital Advances at least thirty (30) days prior to such prepayment, and (B) pays, on the date of such prepayment (w) all outstanding principal due in connection with the Growth Capital Advances, plus accrued and unpaid interest thereon, (x) the Prepayment Fee, (y) the Final Payment and (z) all other sums, if any, that shall have become due and payable hereunder in connection with the Growth Capital Advances.

(ii) Mandatory Prepayment Upon an Acceleration . If the Growth Capital Advances are accelerated following the occurrence of an Event of Default, Borrower shall immediately pay to Bank an amount equal to the sum of (A) all outstanding principal, due in connection with the Growth Capital Advances, plus accrued and unpaid interest thereon, (B) the Prepayment Fee, (C) the Final Payment, and (D) all other sums, if any, that shall have become due and payable hereunder in connection with the Growth Capital Advances.

(d) Uncommitted Incremental Facility . At any time and from time to time, Borrower may request that Bank provide Borrower with an additional credit facility pursuant to which Borrower will obtain up to Twenty-Five Million Dollars ($25,000,000) of additional borrowing availability (the “ Incremental Facility ”). Bank may, in its sole and absolute discretion, grant or deny any such request or requests for an Incremental Facility, and furthermore, any approval of any such request for an Incremental Facility shall be on terms and conditions, and subject to execution of an amendment to this Agreement, acceptable to Bank in its sole and absolute discretion.

2.2 Intentionally Omitted .

2.3 Payment of Interest on the Credit Extensions .

(a) Interest Rate . Subject to Section 2.3(b), the principal amount outstanding under each Growth Capital Advance shall accrue interest at a floating per annum rate equal to the greater of (i) one percentage point (1.00%) above the Prime Rate, or (ii) six percentage points (6.00%), which interest shall be payable monthly in accordance with Section 2.3(d) below.

(b) Default Rate . Immediately upon the occurrence and during the continuance of an Event of Default, Obligations shall bear interest at a rate per annum which is five percentage points (5.0%) above the rate that is otherwise applicable thereto (the “ Default Rate ”). Fees and expenses which are required to be paid by Borrower pursuant to the Loan Documents (including, without limitation, Bank Expenses) but are not paid when due shall bear interest until paid at a rate equal to the highest rate applicable to the Obligations. Payment or acceptance of the increased interest rate provided in this Section 2.3(b) is not a permitted alternative to timely payment and shall not constitute a waiver of any Event of Default or otherwise prejudice or limit any rights or remedies of Bank.

(c) Adjustment to Interest Rate . Changes to the interest rate of any Credit Extension based on changes to the Prime Rate shall be effective on the effective date of any change to the Prime Rate and to the extent of any such change.

(d) Payment; Interest Computation . Interest is payable monthly on the first calendar day of each month and shall be computed on the basis of a three hundred sixty (360) day year for the actual number of days elapsed. In computing interest, (i) all payments received after 12:00 p.m. Pacific time on any day shall be deemed received at the opening of business on the next Business Day, and (ii) the date of the making of any Credit Extension shall be included and the date of payment shall be excluded; provided, however, that if any Credit Extension is repaid on the same day on which it is made, such day shall be included in computing interest on such Credit Extension.

2.4 Fees and Expenses . Borrower shall pay to Bank:

(a) Final Payment . The Final Payment when due hereunder;

(b) Prepayment Fee . The Prepayment Fee, if and when due pursuant to the terms of Section 2.1.1(c); and

 

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(c) Bank Expenses/Good Faith Deposit . All Bank Expenses (including reasonable attorneys’ fees and expenses for documentation and negotiation of this Agreement) incurred through and after the Effective Date, when due (or, if no stated due date, upon demand by Bank); Borrower has paid to Bank a Twenty Thousand Dollars ($20,000) good faith deposit which will be applied to Bank Expenses incurred through the Effective Date.

(d) Fees Fully Earned . Unless otherwise provided in this Agreement or in a separate writing by Bank, Borrower shall not be entitled to any credit, rebate, or repayment of any fees earned by Bank pursuant to this Agreement notwithstanding any termination of this Agreement or the suspension or termination of Bank’s obligation to make loans and advances hereunder. Bank may deduct amounts owing by Borrower under the clauses of this Section 2.4 pursuant to the terms of Section 2.5(c). Bank shall provide Borrower written notice of deductions made from the Designated Deposit Account pursuant to the terms of the clauses of this Section 2.4.

2.5 Payments; Application of Payments; Debit of Accounts .

(a) All payments to be made by Borrower under any Loan Document shall be made in immediately available funds in Dollars, without setoff or counterclaim, before 12:00 p.m. Pacific time on the date when due. Payments of principal and/or interest received after 12:00 p.m. Pacific time are considered received at the opening of business on the next Business Day. When a payment is due on a day that is not a Business Day, the payment shall be due the next Business Day, and additional fees or interest, as applicable, shall continue to accrue until paid.

(b) Bank has the exclusive right to determine the order and manner in which all payments with respect to the Obligations may be applied. Borrower shall have no right to specify the order or the accounts to which Bank shall allocate or apply any payments required to be made by Borrower to Bank or otherwise received by Bank under this Agreement when any such allocation or application is not specified elsewhere in this Agreement.

(c) Bank may debit any of Borrower’s deposit accounts, including the Designated Deposit Account, for principal and interest payments or any other amounts Borrower owes Bank when due. These debits shall not constitute a set-off.kendra

2.6 Withholding . Payments received by Bank from Borrower under this Agreement will be made free and clear of and without deduction for any and all present or future taxes, levies, imposts, duties, deductions, withholdings, assessments, fees or other charges imposed by any Governmental Authority (including any interest, additions to tax or penalties applicable thereto). Specifically, however, if at any time any Governmental Authority, applicable law, regulation or international agreement requires Borrower to make any withholding or deduction from any such payment or other sum payable hereunder to Bank, Borrower hereby covenants and agrees that the amount due from Borrower with respect to such payment or other sum payable hereunder will be increased to the extent necessary to ensure that, after the making of such required withholding or deduction, Bank receives a net sum equal to the sum which it would have received had no withholding or deduction been required, and Borrower shall pay the full amount withheld or deducted to the relevant Governmental Authority. Borrower will, upon request, furnish Bank with proof reasonably satisfactory to Bank indicating that Borrower has made such withholding payment; provided, however, that Borrower need not make any withholding payment if the amount or validity of such withholding payment is contested in good faith by appropriate and timely proceedings and as to which payment in full is bonded or reserved against by Borrower. The agreements and obligations of Borrower contained in this Section 2.6 shall survive the termination of this Agreement.

 

  3

CONDITIONS OF LOANS

3.1 Conditions Precedent to Initial Credit Extension . Bank’s obligation to make the initial Credit Extension is subject to the condition precedent that Bank shall have received, in form and substance satisfactory to Bank, such documents, and completion of such other matters, as Bank may reasonably deem necessary or appropriate, including, without limitation:

(a) duly executed original signatures to the Loan Documents;

 

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(b) duly executed original signatures to a Warrant to Purchase Common Stock issued by Borrower in favor of Bank;

(c) the Operating Documents and long-form good standing certificates of Borrower certified by the Secretary of State (or equivalent agency) of Borrower’s jurisdiction of organization or formation and each jurisdiction in which Borrower is qualified to conduct business, each as of a date no earlier than thirty (30) days prior to the Effective Date;

(d) duly executed original signatures to the completed Borrowing Resolutions for Borrower;

(e) certified copies, dated as of a recent date, of financing statement, UCC and other searches Bank may request, accompanied by written evidence (including any UCC termination statements) that the Liens indicated in any such financing statements either constitute Permitted Liens or have been or, in connection with the initial Credit Extension, will be terminated or released;

(f) the Perfection Certificate of Borrower, together with the duly executed original signature thereto; and

(g) payment of the fees and Bank Expenses then due as specified in Section 2.4 hereof.

3.2 Conditions Precedent to all Credit Extensions . Bank’s obligations to make each Credit Extension, including the initial Credit Extension, is subject to the following conditions precedent:

(a) timely receipt of an executed Payment/Advance Form;

(b) the representations and warranties in this Agreement shall be true, accurate, and complete in all material respects on the date of the Payment/Advance Form and on the Funding Date of each Credit Extension; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material respects as of such date, and no Event of Default shall have occurred and be continuing or result from the Credit Extension. Each Credit Extension is Borrower’s representation and warranty on that date that the representations and warranties in this Agreement remain true, accurate, and complete in all material respects; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material respects as of such date; and

(c) Bank determines to its satisfaction that there has not been a Material Adverse Change.

3.3 Covenant to Deliver .

(a) Except as otherwise provided in Section 3.3(b) and 3.3(c) below, Borrower agrees to deliver to Bank each item required to be delivered to Bank under this Agreement as a condition precedent to any Credit Extension. Borrower expressly agrees that a Credit Extension made prior to the receipt by Bank of any such item shall not constitute a waiver by Bank of Borrower’s obligation to deliver such item, and the making of any Credit Extension in the absence of a required item shall be in Bank’s sole discretion.

(b) As soon as possible, but in any event not later than the date that is thirty (30) days after the Effective Date, Borrower shall deliver to Bank duly executed original signatures to a Control Agreement(s) in favor of Bank from XXX covering all of Borrower’s accounts at XXX except for account no. XXXXXXXXXX (the “ XXX Control Agreements ”) subject to the limitations contained herein;

 

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(c) As soon as possible, but in any event not later than the date that is thirty (30) days after the Effective Date, Borrower shall deliver to Bank evidence satisfactory to Bank that the insurance policies and endorsements required by Section 6.5 hereof are in full force and effect, together with appropriate evidence showing lender loss payable and/or additional insured clauses or endorsements in favor of Bank.

3.4 Procedures for Borrowing . Subject to the prior satisfaction of all other applicable conditions to the making of a Growth Capital Advance set forth in this Agreement, to obtain a Growth Capital Advance, Borrower shall notify Bank (which notice shall be irrevocable) by electronic mail, facsimile, or telephone by 12:00 p.m. Pacific time on the Funding Date of the Growth Capital Advance. Together with any such electronic or facsimile notification, Borrower shall deliver to Bank by electronic mail or facsimile a completed Payment/Advance Form executed by a Responsible Officer or his or her designee. Bank may rely on any telephone notice given by a person whom Bank believes is a Responsible Officer or designee. Bank shall credit Growth Capital Advance to the Designated Deposit Account. Bank may make Growth Capital Advance under this Agreement based on instructions from a Responsible Officer or his or her designee or without instructions if the Growth Capital Advance is necessary to meet Obligations which have become due.

 

  4

CREATION OF SECURITY INTEREST

4.1 Grant of Security Interest . Borrower hereby grants Bank, to secure the payment and performance in full of all of the Obligations, a continuing security interest in, and pledges to Bank, the Collateral, wherever located, whether now owned or hereafter acquired or arising, and all proceeds and products thereof.

Borrower acknowledges that it previously has entered, and/or may in the future enter, into Bank Services Agreements with Bank. Regardless of the terms of any Bank Services Agreement, Borrower agrees that any amounts Borrower owes Bank thereunder shall be deemed to be Obligations hereunder and that it is the intent of Borrower and Bank to have all such Obligations secured by the first priority perfected security interest in the Collateral granted herein (subject only to Permitted Liens that are permitted pursuant to the terms of this Agreement to have superior priority to Bank’s Lien in this Agreement).

If this Agreement is terminated, Bank’s Lien in the Collateral shall continue until the Obligations (other than inchoate indemnity obligations) are repaid in full in cash. Upon payment in full in cash of the Obligations (other than inchoate indemnity obligations) and at such time as Bank’s obligation to make Credit Extensions has terminated, Bank shall, at the sole cost and expense of Borrower, release its Liens in the Collateral and all rights therein shall revert to Borrower. In the event (x) all Obligations (other than inchoate indemnity obligations), except for Bank Services, are satisfied in full, and (y) this Agreement is terminated, Bank shall terminate the security interest granted herein upon Borrower providing cash collateral acceptable to Bank in its good faith business judgment for Bank Services, if any. In the event such Bank Services consist of outstanding Letters of Credit, Borrower shall provide to Bank cash collateral in an amount equal to (x) if such Letters of Credit are denominated in Dollars, then at least one hundred five percent (105.0%); and (y) if such Letters of Credit are denominated in a Foreign Currency, then at least one hundred ten percent (110.0%), of the Dollar Equivalent of the face amount of all such Letters of Credit plus all interest, fees, and costs due or to become due in connection therewith (as estimated by Bank in its business judgment), to secure all of the Obligations relating to such Letters of Credit.

4.2 Priority of Security Interest . Borrower represents, warrants, and covenants that the security interest granted herein is and shall at all times continue to be a first priority perfected security interest in the Collateral (subject only to Permitted Liens that are permitted pursuant to the terms of this Agreement to have superior priority to Bank’s Lien under this Agreement). If Borrower shall acquire a commercial tort claim, Borrower shall promptly notify Bank in a writing signed by Borrower of the general details thereof and grant to Bank in such writing a security interest therein and in the proceeds thereof, all upon the terms of this Agreement, with such writing to be in form and substance reasonably satisfactory to Bank.

4.3 Authorization to File Financing Statements . Borrower hereby authorizes Bank to file financing statements, without notice to Borrower, with all appropriate jurisdictions to perfect or protect Bank’s interest or rights hereunder, including a notice that any disposition of the Collateral, by either Borrower or any other Person, not otherwise permitted under the applicable Loan Documents, shall be deemed to violate the rights of Bank under the Code.

 

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4.4 ULC Shares . Borrower acknowledges that certain of the Collateral may now or in the future consist of shares of an unlimited liability company (the “ ULC Shares ”), and that it is the intention of Bank and Borrower that neither Bank nor any beneficiary, successor in interest, agent or any other Affiliate of Bank should under any circumstances prior to realization thereon be held to be a “member” or a “shareholder”, as applicable, of an unlimited liability company (as organized under the laws of any Province or Territory in Canada, each a “ ULC ”) for the purposes of any legislation governing such ULC. Therefore, notwithstanding any provisions to the contrary contained in this Agreement or any other Loan Document, where Borrower is the registered owner of ULC Shares which are Collateral, Borrower will remain the sole registered owner of such ULC Shares until such time as such ULC Shares are effectively transferred into the name of Bank or any beneficiary, successor in interest, agent or any other Affiliate of Bank, or any other Person on the books and records of the applicable ULC. Accordingly, Borrower shall be entitled to receive and retain for its own account any cash dividend on or other distribution, if any, in respect of such ULC Shares (except for any stock dividend or distribution which shall be subject to the security interest created hereunder and to this Section 4.4) and shall have the right to vote such ULC Shares and to control the direction, management and policies of the applicable ULC to the same extent as Borrower would if such ULC Shares were not pledged to Bank pursuant hereto. Nothing in this Agreement or any other Loan Document is intended to, and nothing in this Agreement or any other Loan Document shall, constitute Bank or any beneficiary, successor in interest, agent or any other Affiliate of Bank, or any other Person other than Borrower, a member or shareholder of a ULC for the purposes of any legislation governing such ULC (whether listed or unlisted, registered or beneficial), until such time as notice is given to Borrower and further steps are taken pursuant hereto or thereto so as to register Bank or any beneficiary, successor in interest, agent or any other Affiliate of Bank, or such other Person, as specified in such notice, as the holder of the ULC Shares. To the extent any provision hereof would have the effect of constituting Bank, or any beneficiary, successor in interest, agent or any other Affiliate of Bank as a member or a shareholder, as applicable, of any ULC prior to such time, such provision shall be severed herefrom and shall be ineffective with respect to ULC Shares which are Collateral without otherwise invalidating or rendering unenforceable this Agreement or invalidating or rendering unenforceable such provision insofar as it relates to Collateral which is not ULC Shares. Except upon the exercise of rights of Bank to sell, transfer or otherwise dispose of ULC Shares in accordance with this Agreement, Borrower shall not cause Bank or any beneficiary, successor in interest, agent or any other Affiliate of Bank to: (a) be registered as a shareholder or member of such ULC; (b) have any notation entered in their favor in the share register of such ULC; (c) be held out as shareholders or members of such ULC; (d) receive, directly or indirectly, any dividends, property or other distributions from such ULC by reason solely of Bank holding a security interest over the ULC Shares; or (e) act as a shareholder of such ULC, or exercise any rights of a shareholder including the right to attend a meeting of shareholders of such ULC or to vote Borrower’s ULC Shares.

 

  5

REPRESENTATIONS AND WARRANTIES

Borrower represents and warrants as follows:

5.1 Due Organization, Authorization; Power and Authority . Borrower is duly existing and in good standing as a Registered Organization in its jurisdiction of formation and is qualified and licensed to do business and is in good standing in any jurisdiction in which the conduct of its business or its ownership of property requires that it be qualified except where the failure to do so could not reasonably be expected to have a material adverse effect on Borrower’s business. In connection with this Agreement, Borrower has delivered to Bank a completed certificate signed by Borrower, entitled “Perfection Certificate” (the “ Perfection Certificate ”). Borrower represents and warrants to Bank that (a) Borrower’s exact legal name is that indicated on the Perfection Certificate and on the signature page hereof; (b) Borrower is an organization of the type and is organized in the jurisdiction set forth in the Perfection Certificate; (c) the Perfection Certificate accurately sets forth Borrower’s organizational identification number or accurately states that Borrower has none; (d) the Perfection Certificate accurately sets forth Borrower’s place of business, or, if more than one, its chief executive office as well as Borrower’s mailing address (if different than its chief executive office); (e) Borrower (and each of its predecessors) has not, in the past five (5) years, changed its jurisdiction of formation, organizational structure or type, or any organizational number assigned by its jurisdiction; and (f) all other information set forth on the Perfection Certificate pertaining to Borrower and each of its Subsidiaries is accurate and complete (it being understood and agreed that Borrower may from time to time update certain information in the Perfection Certificate after the Effective Date to the extent permitted by one or more specific provisions in this Agreement). If Borrower is not now a Registered Organization but later becomes one, Borrower shall promptly notify Bank of such occurrence and provide Bank with Borrower’s organizational identification number.

 

 

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The execution, delivery and performance by Borrower of the Loan Documents to which it is a party have been duly authorized, and do not (i) conflict with any of Borrower’s organizational documents, (ii) contravene, conflict with, constitute a default under or violate any material Requirement of Law, (iii) contravene, conflict or violate any applicable order, writ, judgment, injunction, decree, determination or award of any Governmental Authority by which Borrower or any of its Subsidiaries or any of their property or assets may be bound or affected, (iv) require any action by, filing, registration, or qualification with, or Governmental Approval from, any Governmental Authority (except such Governmental Approvals which have already been obtained and are in full force and effect) or (v) conflict with, contravene, constitute a default or breach under, or result in or permit the termination or acceleration of, any material agreement by which Borrower is bound. Borrower is not in default under any agreement to which it is a party or by which it is bound in which the default could reasonably be expected to have a material adverse effect on Borrower’s business.

5.2 Collateral . Borrower has good title to, rights in, and the power to transfer each item of the Collateral upon which it purports to grant a Lien hereunder, free and clear of any and all Liens except Permitted Liens. Borrower has no Collateral Accounts at or with any bank or financial institution other than Bank or Bank’s Affiliates except for the Collateral Accounts described in the Perfection Certificate delivered to Bank in connection herewith and which Borrower has taken such actions as are necessary to give Bank a perfected security interest therein, pursuant to the terms of Section 6.6(b). The Accounts are bona fide, existing obligations of the Account Debtors.

The Collateral is not in the possession of any third party bailee (such as a warehouse) except as otherwise provided in the Perfection Certificate or as disclosed pursuant to Section 7.2 hereof. None of the components of the Collateral shall be maintained at locations other than as provided in the Perfection Certificate or as permitted pursuant to Section 7.2

Borrower is the sole owner of the Intellectual Property which it owns or purports to own except for (a) non-exclusive licenses granted to its customers in the ordinary course of business, (b) over-the-counter software that is commercially available to the public, and (c) material Intellectual Property licensed to Borrower and noted on the Perfection Certificate. To the best of Borrower’s knowledge, each Patent which it owns or purports to own and which is material to Borrower’s business is valid and enforceable, and no part of the Intellectual Property which Borrower owns or purports to own and which is material to Borrower’s business has been judged invalid or unenforceable, in whole or in part. To the best of Borrower’s knowledge, no claim has been made that any part of the Intellectual Property violates the rights of any third party except to the extent such claim would not reasonably be expected to have a material adverse effect on Borrower’s business.

Except as noted on the Perfection Certificate, Borrower is not a party to, nor is it bound by, any Restricted License.

5.3 Intentionally Omitted .

5.4 Litigation . There are no actions or proceedings pending or, to the knowledge of any Responsible Officer, threatened in writing by or against Borrower or any of its Subsidiaries involving more than, individually or in the aggregate, [***].

5.5 Financial Statements; Financial Condition . All consolidated financial statements for Borrower and any of its Subsidiaries delivered to Bank by submission to the Financial Statement Repository or otherwise submitted to Bank fairly present in all material respects Borrower’s consolidated financial condition and Borrower’s consolidated results of operations. There has not been any material deterioration in Borrower’s consolidated financial condition since the date of the most recent financial statements submitted to the Financial Statement Repository or otherwise submitted to Bank.

 

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*** Confidential Treatment Requested.


5.6 Solvency . The fair salable value of Borrower’s consolidated assets (including goodwill minus disposition costs) exceeds the fair value of Borrower’s liabilities; Borrower is not left with unreasonably small capital after the transactions in this Agreement; and Borrower is able to pay its debts (including trade debts) as they mature.

5.7 Regulatory Compliance . Borrower is not an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended. Borrower is not engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors). Borrower (a) has complied in all material respects with all Requirements of Law, and (b) has not violated any Requirements of Law the violation of which could reasonably be expected to have a material adverse effect on its business. None of Borrower’s or any of its Subsidiaries’ properties or assets has been used by Borrower or any Subsidiary or, to the best of Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than legally. Borrower and each of its Subsidiaries have obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted.

5.8 Subsidiaries; Investments . Borrower does not own any stock, partnership, or other ownership interest or other equity securities except for Permitted Investments.

5.9 Tax Returns and Payments; Pension Contributions . Borrower has timely filed all required tax returns and reports, and Borrower has timely paid all foreign, federal, state and local taxes, assessments, deposits and contributions owed by Borrower except to the extent such taxes are being contested in good faith by appropriate proceedings promptly instituted and diligently conducted, so long as such reserve or other appropriate provision, if any, as shall be required in conformity with GAAP shall have been made therefor.

To the extent Borrower defers payment of any contested taxes, Borrower shall (i) notify Bank in writing of the commencement of, and any material development in, the proceedings, and (ii) post bonds or take any other steps required to prevent the Governmental Authority levying such contested taxes from obtaining a Lien upon any of the Collateral that is other than a “Permitted Lien.” Borrower is unaware of any claims or adjustments proposed for any of Borrower’s prior tax years which could result in additional taxes becoming due and payable by Borrower. Borrower has paid all amounts necessary to fund all present pension, profit sharing and deferred compensation plans in accordance with their terms, and Borrower has not withdrawn from participation in, and has not permitted partial or complete termination of, or permitted the occurrence of any other event with respect to, any such plan which could reasonably be expected to result in any liability of Borrower, including any liability to the Pension Benefit Guaranty Corporation or its successors or any other governmental agency.

5.10 Use of Proceeds . Borrower shall use the proceeds of the Credit Extensions solely as working capital and to fund its general business requirements and not for personal, family, household or agricultural purposes.

5.11 Full Disclosure . No written representation, warranty or other statement of Borrower in any report, certificate, or written statement submitted to the Financial Statement Repository or otherwise submitted to Bank, as of the date such representation, warranty, or other statement was made, taken together with all such written reports, written certificates and written statements submitted to the Financial Statement Repository or otherwise submitted to Bank, contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements contained in the reports, certificates, or written statements not misleading (it being recognized by Bank that the projections and forecasts provided by Borrower in good faith and based upon reasonable assumptions are not viewed as facts and that actual results during the period or periods covered by such projections and forecasts may differ from the projected or forecasted results).

5.12 Definition of “Knowledge.” For purposes of the Loan Documents, whenever a representation or warranty is made to Borrower’s knowledge or awareness, to the “best of” Borrower’s knowledge, or with a similar qualification, knowledge or awareness means the actual knowledge, after reasonable investigation, of any Responsible Officer.

 

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  6

AFFIRMATIVE COVENANTS

Borrower shall do all of the following from the Effective Date until this Agreement is terminated in accordance with Section 12.1:

6.1 Government Compliance .

(a) Maintain its and all its Subsidiaries’ legal existence and good standing in their respective jurisdictions of formation and maintain qualification in each jurisdiction in which the failure to so qualify would reasonably be expected to have a material adverse effect on Borrower’s business or operations. Borrower shall comply, and have each Subsidiary comply, in all material respects, with all laws, ordinances and regulations to which it is subject.

(b) Obtain all of the Governmental Approvals necessary for the performance by Borrower of its obligations under the Loan Documents to which it is a party and the grant of a security interest to Bank in all of its property. Borrower shall promptly provide copies of any such obtained Governmental Approvals to Bank.

6.2 Financial Statements, Reports . Provide Bank with the following by submitting to the Financial Statement Repository or otherwise submitting to Bank:

(a) Monthly Cash Statements . As soon as available, but no later than thirty (30) days after the last day of each month, a statement listing Borrower’s and its Subsidiaries’ cash and Cash Equivalents in accounts at all financial institutions in a form acceptable to Bank (the “ Monthly Cash Statements ”);

(b) Monthly Compliance Statement . Within thirty (30) days after the last day of each month and together with the Monthly Cash Statements, a duly completed Compliance Statement, confirming that as of the end of such month, Borrower was in full compliance with all of the terms and conditions of this Agreement, and setting forth calculations showing compliance with the financial covenants set forth in this Agreement and such other information as Bank may reasonably request;

(c) Annual Operating Budget and Financial Projections . Within the earlier of (i) thirty (30) days after approval of the same by Borrower’s board of directors or (ii) ninety (90) days after the end of each fiscal year of Borrower and within seven (7) days of any updates or amendments thereto, (A) annual operating budgets (including income statements, and statements of projected cash balances, by quarter) for the then-current fiscal year of Borrower, and (B) annual financial projections for the then-current fiscal year (on a quarterly basis) as approved by Borrower’s board of directors, together with any related business forecasts used in the preparation of such annual financial projections;

(d) Other Statements . Within five (5) days of delivery, copies of all statements, reports and notices made available to Borrower’s security holders or to any holders of Subordinated Debt;

(e) SEC Filings . Within five (5) days of filing, but in any event (i) not later than forty-five (45) days of each fiscal quarter end with respect to Borrower’s 10Q filing and (ii) not later than ninety (90) days of each fiscal year end with respect to Borrower’s 10K filing, copies of all periodic and other reports, proxy statements (provided that the proxy statement need only be provided within one hundred twenty (120) days after the end of each fiscal year) and other materials filed by Borrower with the SEC, any Governmental Authority succeeding to any or all of the functions of the SEC or with any national securities exchange, or distributed to its shareholders, as the case may be. Documents required to be delivered pursuant to the terms hereof (to the extent any such documents are included in materials otherwise filed with the SEC) may be delivered electronically and if so delivered, shall be deemed to have been delivered on the date on which Borrower posts such documents, or provides a link thereto, on Borrower’s website on the Internet at Borrower’s website address; provided, however, Borrower shall promptly notify Bank in writing (which may be by electronic mail) of the posting of any such documents;

 

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(f) Legal Action Notice . Promptly after becoming aware thereof, a prompt report of any legal actions pending or threatened in writing against Borrower or any of its Subsidiaries that could result in damages or costs to Borrower or any of its Subsidiaries of, individually or in the aggregate, One Hundred Thousand Dollars ($100,000) or more;

(g) Beneficial Ownership . Prompt written notice of any changes to the beneficial ownership information set out in item 13 of the Perfection Certificate. Borrower understands and acknowledges that Bank relies on such true, accurate and up-to-date beneficial ownership information to meet Bank’s regulatory obligations to obtain, verify and record information about the beneficial owners of its legal entity customers; and

(h) Other Financial Information . Other financial information reasonably requested by Bank.

Any submission by Borrower of a Compliance Statement or any other financial statement submitted to the Financial Statement Repository pursuant to this Section 6.2 or otherwise submitted to Bank shall be deemed to be a representation by Borrower that (a) as of the date of such Compliance Statement or other financial statement, the information and calculations set forth therein are true, accurate and correct, (b) as of the end of the compliance period set forth in such submission, Borrower is in complete compliance with all required covenants except as noted in such Compliance Statement or other financial statement, as applicable; (c) as of the date of such submission, no Events of Default have occurred or are continuing; (d) all representations and warranties other than any representations or warranties that are made as of a specific date in Article 5 remain true and correct in all material respects as of the date of such submission except as noted in such Compliance Statement or other financial statement, as applicable; (e) as of the date of such submission, Borrower and each of its Subsidiaries has timely filed all required tax returns and reports, and Borrower has timely paid all foreign, federal, state and local taxes, assessments, deposits and contributions owed by Borrower except as otherwise permitted pursuant to the terms of Section 5.9; and (f) as of the date of such submission, no Liens have been levied or claims made against Borrower or any of its Subsidiaries relating to unpaid employee payroll or benefits of which Borrower has not previously provided written notification to Bank.

6.3 Inventory; Returns . Keep all Inventory in good and marketable condition, free from material defects. Returns and allowances between Borrower and its Account Debtors shall follow Borrower’s customary practices as they exist at the Effective Date. Borrower must promptly notify Bank of all returns, recoveries, disputes and claims that involve more than One Hundred Thousand Dollars ($100,000).

6.4 Taxes; Pensions . Timely file, and require each of its Subsidiaries to timely file, all required tax returns and reports and timely pay, and require each of its Subsidiaries to timely pay, all foreign, federal, state and local taxes, assessments, deposits and contributions owed by Borrower and each of its Subsidiaries, except for deferred payment of any taxes contested pursuant to the terms of Section 5.9 hereof, and shall deliver to Bank, on demand, appropriate certificates attesting to such payments, and pay all amounts necessary to fund all present pension, profit sharing and deferred compensation plans in accordance with their terms.

6.5 Insurance .

(a) Keep its business and the Collateral insured for risks and in amounts standard for companies in Borrower’s industry and location and as Bank may reasonably request. Insurance policies shall be in a form, with financially sound and reputable insurance companies that are not Affiliates of Borrower, and in amounts that are satisfactory to Bank. All property policies shall have a lender’s loss payable endorsement showing Bank as lender loss payee. All liability policies shall show, or have endorsements showing, Bank as an additional insured. Bank shall be named as lender loss payee and/or additional insured with respect to any such insurance providing coverage in respect of any Collateral.

(b) Ensure that proceeds payable under any property policy are, at Bank’s option, payable to Bank on account of the Obligations. Notwithstanding the foregoing, (a) so long as no Event of Default has occurred and is continuing, Borrower shall have the option of applying the proceeds of any casualty policy up to Two Hundred Fifty Thousand Dollars ($250,000) with respect to any loss, but not exceeding Five Hundred Thousand Dollars ($500,000) in the aggregate for all losses under all casualty policies in any one year, toward the replacement or repair of destroyed or damaged property; provided that any such replaced or repaired property (i) shall be of equal or like value as the replaced or repaired Collateral and (ii) shall be deemed Collateral in which Bank has been granted a first priority security interest, and (b) after the occurrence and during the continuance of an Event of Default, all proceeds payable under such casualty policy shall, at the option of Bank, be payable to Bank on account of the Obligations.

 

 

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(c) At Bank’s request, Borrower shall deliver certified copies of insurance policies and evidence of all premium payments. Each provider of any such insurance required under this Section 6.5 shall agree, by endorsement upon the policy or policies issued by it or by independent instruments furnished to Bank, that it will give Bank thirty (30) days prior written notice, except for non-payment of premium in which case the notice period is ten (10) days, before any such policy or policies shall be materially altered or canceled. If Borrower fails to obtain insurance as required under this Section 6.5 or to pay any amount or furnish any required proof of payment to third persons and Bank, Bank may make all or part of such payment or obtain such insurance policies required in this Section 6.5, and take any action under the policies Bank deems prudent.

6.6 Operating Accounts .

(a) Maintain at all times on deposit with Bank the lesser of (i) Ten Million Dollars ($10,000,000) in cash and Cash Equivalents or (ii) eighty percent (80%) of the aggregate dollar value of Borrower’s and its Subsidiaries’ cash and Cash Equivalents in accounts at all financial institutions. Notwithstanding the foregoing, for a period of time not to exceed thirty (30) days after the Effective Date, Borrower may instead maintain only Five Million Dollars ($5,000,000) in cash and Cash Equivalents at Bank provided that until Borrower (A) is in compliance with the requirements set forth in the first sentence of this paragraph 6.6(a) and (B) has delivered the XXX Control Agreements to Bank, Borrower shall not, at any time, transfer any funds out of or otherwise debit Borrower’s accounts at Bank. Borrower agrees to evaluate in good faith the corporate credit card program offered by Bank within one hundred twenty (120) days of the Effective Date to potentially transition its and its Subsidiaries’ program.

(b) Provide Bank five (5) days prior written notice before establishing any Collateral Account at or with any bank or financial institution other than Bank or Bank’s Affiliates. For each Collateral Account that Borrower at any time maintains, Borrower shall cause the applicable bank or financial institution (other than Bank) at or with which any Collateral Account is maintained to execute and deliver a Control Agreement or other appropriate instrument with respect to such Collateral Account to perfect Bank’s Lien in such Collateral Account in accordance with the terms hereunder which Control Agreement may not be terminated without the prior written consent of Bank. The provisions of the previous sentence shall not apply to (i) deposit accounts exclusively used for payroll, payroll taxes and other employee wage and benefit payments to or for the benefit of Borrower’s employees and identified to Bank by Borrower as such or (ii) Borrower’s account no. XXXXXXXXXX at XXX Bank so long as the aggregate amount of cash and Cash Equivalents therein does not at any time exceed Three Hundred Thousand Dollars ($300,000). In addition so long as Borrower’s aggregate cash and Cash Equivalents (as reported in the most recent Monthly Cash Statements) is greater than or equal to Fifty Million Dollars ($50,000,000), Borrower shall not be required to obtain a Control Agreement for accounts held at XXX Securities. If at any time, Borrower’s aggregate cash and Cash Equivalents (as reported in the most recent Monthly Cash Statements) is less than Fifty Million Dollars ($50,000,000), Borrower shall immediately (i) provide Bank with a fully executed Control Agreement for Borrower’s accounts at XXX Securities or (ii) transfer all funds contained therein to accounts at Bank, Bank’s Affiliates or another financial institution where such accounts are subject to a Control Agreement.

6.7 Intentionally Omitted .

6.8 Protection of Intellectual Property Rights .

(a)(i) Protect, defend and maintain the validity and enforceability of its Intellectual Property; (ii) promptly advise Bank in writing promptly after becoming aware thereof of material infringements or any other event that could reasonably be expected to materially and adversely affect the value of its Intellectual Property; and (iii) not allow any Intellectual Property material to Borrower’s business to be abandoned, forfeited or dedicated to the public without Bank’s written consent.

 

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(b) Provide written notice to Bank within ten (10) days of entering or becoming bound by any Restricted License (other than over-the-counter software that is commercially available to the public). Borrower shall use commercially reasonable efforts at Bank’s requests to obtain the consent of, or waiver by, any person whose consent or waiver is necessary for (i) any Restricted License to be deemed “Collateral” and for Bank to have a security interest in it that is otherwise be restricted or prohibited by law or by the terms of any such Restricted License, whether now existing or entered into in the future, and (ii) Bank to have the ability in the event of a liquidation of any Collateral to dispose of such Collateral in accordance with Bank’s rights and remedies under this Agreement and the other Loan Documents.

6.9 Litigation Cooperation . From the date hereof and continuing through the termination of this Agreement, make available to Bank, without expense to Bank, Borrower and its officers, employees and agents and Borrower’s books and records, to the extent that Bank may deem them reasonably necessary to prosecute or defend any third-party suit or proceeding instituted by or against Bank with respect to any Collateral or relating to Borrower.

6.10 Access to Collateral; Books and Records . Allow Bank, or its agents, at reasonable times, on ten (10) Business Days’ notice (provided no notice is required if an Event of Default has occurred and is continuing), to inspect the Collateral and audit and copy Borrower’s Books. Such inspections or audits shall be conducted no more often than once every twelve (12) months unless an Event of Default has occurred and is continuing in which case such inspections and audits shall occur as often as Bank shall determine is necessary. The foregoing inspections and audits shall be at Borrower’s expense, and the charge therefor shall be One Thousand Dollars ($1,000) per person per day (or such higher amount as shall represent Bank’s then-current standard charge for the same), plus reasonable out-of-pocket expenses. In the event Borrower and Bank schedule an audit more than eight (8) days in advance, and Borrower cancels or seeks to reschedule the audit with less than eight (8) days written notice to Bank, then (without limiting any of Bank’s rights or remedies), Borrower shall pay Bank a fee of Two Thousand Dollars ($2,000) plus any out-of-pocket expenses incurred by Bank to compensate Bank for the anticipated costs and expenses of the cancellation or rescheduling.

6.11 Formation or Acquisition of Subsidiaries . Notwithstanding and without limiting the negative covenants contained in Sections 7.3 and 7.7 hereof, at the time that Borrower or any Guarantor forms any new direct or indirect Subsidiary or acquires any direct or indirect Subsidiary after the Effective Date, Borrower and such Guarantor shall (a) cause any such new Domestic Subsidiary to provide to Bank a joinder to the Loan Agreement to cause such Subsidiary to become a co-borrower or Guarantor (as determined by Bank in its sole discretion) hereunder, together with such appropriate financing statements and/or Control Agreements, all in form and substance satisfactory to Bank (including being sufficient to grant Bank a first priority Lien (subject to Permitted Liens) in and to the assets of such newly formed or acquired Domestic Subsidiary), (b) provide to Bank appropriate certificates and powers and financing statements, pledging all of the direct or beneficial ownership interest in such new Subsidiary, in form and substance satisfactory to Bank (or in the case of a Foreign Subsidiary), up to sixty five percent (65%) of the issued and outstanding equity interests owned by a Borrower of any such Foreign Subsidiary which shares entitle the holder thereof to vote for the election of directors or any other matter, in form and substance satisfactory to Bank, and (c) provide to Bank all other documentation in form and substance satisfactory to Bank with respect to the execution and delivery of the applicable documentation referred to above. Any document, agreement, or instrument executed or issued pursuant to this Section 6.11 shall be a Loan Document.

6.12 Further Assurances . Execute any further instruments and take further action as Bank reasonably requests to perfect or continue Bank’s Lien in the Collateral or to effect the purposes of this Agreement. Deliver to Bank, within five (5) days after the same are sent or received, copies of all correspondence, reports, documents and other filings with any Governmental Authority regarding compliance with or maintenance of Governmental Approvals or Requirements of Law or that could reasonably be expected to have a material effect on any of the Governmental Approvals or otherwise on the operations of Borrower or any of its Subsidiaries.

 

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  7

NEGATIVE COVENANTS

From the Effective Date until this Agreement is terminated in accordance with Section 12.1, Borrower shall not do any of the following without Bank’s prior written consent:

7.1 Dispositions . Convey, sell, lease, transfer, assign, or otherwise dispose of (collectively, “ Transfer ”), or permit any of its Subsidiaries to Transfer, all or any part of its business or property, except for Transfers (a) of Inventory in the ordinary course of business; (b) of worn-out or obsolete Equipment that is, in the reasonable judgment of Borrower, no longer economically practicable to maintain or useful in the ordinary course of business of Borrower; (c) consisting of Permitted Liens and Permitted Investments; (d) consisting of the sale or issuance of any stock of Borrower permitted under Section 7.2 of this Agreement; (e) consisting of Borrower’s use or transfer of money or Cash Equivalents in a manner that is not prohibited by the terms of this Agreement or the other Loan Documents; and (f) of non-exclusive licenses for the use of the property of Borrower or its Subsidiaries in the ordinary course of business and licenses that could not result in a legal transfer of title of the licensed property but that may be exclusive in respects other than territory and that may be exclusive as to territory only as to discreet geographical territories outside of the United States.

7.2 Changes in Business, Management, Control, or Business Locations . (a) Engage in or permit any of its Subsidiaries to engage in any business other than the businesses currently engaged in by Borrower and such Subsidiary, as applicable, or reasonably related thereto; (b) liquidate or dissolve; (c) (i) fail to provide notice to Bank of any Key Person departing from or ceasing to be employed by Borrower within five (5) days after his or her departure from Borrower; or (d) permit or suffer any Change in Control.

Borrower shall not, without at least thirty (30) days prior written notice to Bank: (1) add any new offices or business locations, including warehouses (unless such new offices or business locations contain less than Five Hundred Thousand Dollars ($500,000) in Borrower’s assets or property) or deliver any portion of the Collateral valued, individually or in the aggregate, in excess of Five Million Dollars ($5,000,000) to a bailee at a location other than to a bailee and at a location already disclosed in the Perfection Certificate, (2) change its jurisdiction of organization, (3) change its organizational structure or type, (4) change its legal name, or (5) change any organizational number (if any) assigned by its jurisdiction of organization. If Borrower intends to deliver any portion of the Collateral valued, individually or in the aggregate, in excess of Five Million Dollars ($5,000,000) to a bailee, and Bank and such bailee are not already parties to a bailee agreement governing both the Collateral and the location to which Borrower intends to deliver the Collateral, then Borrower will first receive the written consent of Bank, and such bailee shall execute and deliver a bailee agreement in form and substance satisfactory to Bank. If Borrower intends to deliver any portion of the Collateral valued, individually or in the aggregate, in excess of Five Hundred Thousand Dollars ($500,000) to a landlord, and Bank and such landord are not already parties to a landlord waiver governing both the Collateral and the location to which Borrower intends to deliver the Collateral, then Borrower will first receive the written consent of Bank, and such landlord shall execute and deliver a landlord waiver in form and substance satisfactory to Bank.

7.3 Mergers or Acquisitions . Merge or consolidate, or permit any of its Subsidiaries to merge or consolidate, with any other Person, or acquire, or permit any of its Subsidiaries to acquire, all or substantially all of the capital stock or property of another Person (including, without limitation, by the formation of any Subsidiary). A Subsidiary may merge or consolidate into another Subsidiary or into Borrower.

7.4 Indebtedness . Create, incur, assume, or be liable for any Indebtedness, or permit any Subsidiary to do so, other than Permitted Indebtedness.

7.5 Encumbrance . Create, incur, allow, or suffer any Lien on any of its property, or assign or convey any right to receive income, including the sale of any Accounts, or permit any of its Subsidiaries to do so, except for Permitted Liens, permit any Collateral not to be subject to the first priority security interest granted herein, or enter into any agreement, document, instrument or other arrangement (except with or in favor of Bank) with any Person which directly or indirectly prohibits or has the effect of prohibiting Borrower or any Subsidiary from assigning, mortgaging, pledging, granting a security interest in or upon, or encumbering any of Borrower’s or any Subsidiary’s Intellectual Property, except as is otherwise permitted in Section 7.1 hereof and the definition of “Permitted Liens” herein.

7.6 Maintenance of Collateral Accounts . Maintain any Collateral Account except pursuant to the terms of Section 6.6 hereof.

 

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7.7 Distributions; Investments . (a) Pay any dividends or make any distribution or payment or redeem, retire or purchase any capital stock provided that (i) Borrower may convert any of its convertible securities into other securities pursuant to the terms of such convertible securities or otherwise in exchange thereof, (ii) Borrower may pay dividends solely in common stock; and (iii) Borrower may repurchase the stock of former employees or consultants pursuant to stock repurchase agreements so long as an Event of Default does not exist at the time of such repurchase and would not exist after giving effect to such repurchase, provided that the aggregate amount of all such repurchases does not exceed Two Hundred Thousand Dollars ($200,000) per fiscal year; or (b) directly or indirectly make any Investment (including, without limitation, by the formation of any Subsidiary) other than Permitted Investments, or permit any of its Subsidiaries to do so.

7.8 Transactions with Affiliates . Directly or indirectly enter into or permit to exist any material transaction with any Affiliate of Borrower, except for transactions that are in the ordinary course of Borrower’s business, upon fair and reasonable terms that are no less favorable to Borrower than would be obtained in an arm’s length transaction with a non-affiliated Person.

7.9 Subordinated Debt . (a) Make or permit any payment on any Subordinated Debt, except under the terms of the subordination, intercreditor, or other similar agreement to which such Subordinated Debt is subject, or (b) amend any provision in any document relating to the Subordinated Debt which would increase the amount thereof, provide for earlier or greater principal, interest, or other payments thereon, or adversely affect the subordination thereof to Obligations owed to Bank.

7.10 Compliance . Become an “investment company” or a company controlled by an “investment company”, under the Investment Company Act of 1940, as amended, or undertake as one of its important activities extending credit to purchase or carry margin stock (as defined in Regulation U of the Board of Governors of the Federal Reserve System), or use the proceeds of any Credit Extension for that purpose; fail to (a) meet the minimum funding requirements of ERISA, (b) prevent a Reportable Event or Prohibited Transaction as defined in ERISA, or (c) comply with the Federal Labor Standards Act, the failure of any of the conditions in clauses (a) through (c) which could reasonably be expected to have a material adverse effect on Borrower’s business, or violate any other law or regulation, if the violation could reasonably be expected to have a materials adverse effect on Borrower’s business or permit any Subsidiaries to do so; withdraw or permit any Subsidiary to withdraw from participation in, permit partial or complete termination of, or permit the occurrence of any other event with respect to, any present pension, profit sharing and deferred compensation plan which could reasonably be expected to result in any liability of Borrower, including any liability to the Pension Benefit Guaranty Corporation or its successors or any other governmental agency.

7.11 Subsidiary Assets . Permit the aggregate value of cash and Cash Equivalent assets held by Sierra Oncology Canada ULC to exceed the lesser of (i) Three Million Dollars ($3,000,000) (measured on an average basis at the end of each calendar month), or (ii) ten percent (10%) of the aggregate dollar value of Borrower’s and its Subsidiaries’ cash and Cash Equivalents in accounts at all financial institutions.

 

  8

EVENTS OF DEFAULT

Any one of the following shall constitute an event of default (an “ Event of Default ”) under this Agreement:

8.1 Payment Default . Borrower fails to (a) make any payment of principal or interest on any Credit Extension when due, or (b) pay any other Obligations within three (3) Business Days after such Obligations are due and payable (which three (3) Business Day cure period shall not apply to payments due on the Growth Capital Maturity Date). During the cure period, the failure to make or pay any payment specified under clause (b) hereunder is not an Event of Default (but no Credit Extension will be made during the cure period);

8.2 Covenant Default .

(a) Borrower fails or neglects to perform any obligation in Sections 6.2, 6.4, 6.5, 6.6, 6.8(b), 6.10, 6.11, 6.12 or violates any covenant in Section 7; or

 

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(b) Borrower fails or neglects to perform, keep, or observe any other term, provision, condition, covenant or agreement contained in this Agreement or any Loan Documents, and as to any default (other than those specified in this Section 8) under such other term, provision, condition, covenant or agreement that can be cured, has failed to cure the default within ten (10) days after the occurrence thereof; provided, however, that if the default cannot by its nature be cured within the ten (10) day period or cannot after diligent attempts by Borrower be cured within such ten (10) day period, and such default is likely to be cured within a reasonable time, then Borrower shall have an additional period (which shall not in any case exceed thirty (30) days) to attempt to cure such default, and within such reasonable time period the failure to cure the default shall not be deemed an Event of Default (but no Credit Extensions shall be made during such cure period). Cure periods provided under this section shall not apply, among other things, to financial covenants or any other covenants set forth in clause (a) above;

8.3 Material Adverse Change . A Material Adverse Change occurs;

8.4 Attachment; Levy; Restraint on Business .

(a)(i) The service of process seeking to attach, by trustee or similar process, any funds of Borrower or of any entity under the control of Borrower (including a Subsidiary), or (ii) a notice of lien or levy is filed against any of Borrower’s assets by any Governmental Authority, and the same under subclauses (i) and (ii) hereof are not, within ten (10) days after the occurrence thereof, discharged or stayed (whether through the posting of a bond or otherwise); provided, however, no Credit Extensions shall be made during any ten (10) day cure period; or

(b)(i) any material portion of Borrower’s assets is attached, seized, levied on, or comes into possession of a trustee or receiver, or (ii) any court order enjoins, restrains, or prevents Borrower from conducting all or any material part of its business;

8.5 Insolvency . (a) Borrower or any of its Subsidiaries is unable to pay its debts (including trade debts) as they become due or otherwise becomes insolvent; (b) Borrower or any of its Subsidiaries begins an Insolvency Proceeding; or (c) an Insolvency Proceeding is begun against Borrower or any of its Subsidiaries and is not dismissed or stayed within forty five (45) days (but no Credit Extensions shall be made while any of the conditions described in clause (a) exist and/or until any Insolvency Proceeding is dismissed);

8.6 Other Agreements . There is, under any agreement to which Borrower or any Guarantor is a party with a third party or parties, (a) any default resulting in a right by such third party or parties, whether or not exercised, to accelerate the maturity of any Indebtedness in an amount individually or in the aggregate in excess of One Hundred Thousand Dollars ($100,000); or (b) any breach or default by Borrower or Guarantor, the result of which could have a material adverse effect on Borrower’s or any Guarantor’s business;

8.7 Judgments; Penalties . One or more fines, penalties or final judgments, orders or decrees for the payment of money in an amount, individually or in the aggregate, of at least One Hundred Thousand Dollars ($100,000) (not covered by independent third-party insurance as to which liability has been accepted by such insurance carrier) shall be rendered against Borrower by any Governmental Authority, and the same are not, within ten (10) days after the entry, assessment or issuance thereof, discharged, satisfied, or paid, or after execution thereof, stayed or bonded pending appeal, or such judgments are not discharged prior to the expiration of any such stay (provided that no Credit Extensions will be made prior to the satisfaction, payment, discharge, stay, or bonding of such fine, penalty, judgment, order or decree);

8.8 Misrepresentations . Borrower or any Person acting for Borrower makes any representation, warranty, or other statement now or later in this Agreement, any Loan Document or in any writing delivered to Bank or to induce Bank to enter this Agreement or any Loan Document, and such representation, warranty, or other statement is incorrect in any material respect when made;

8.9 Subordinated Debt . Any document, instrument, or agreement evidencing any Subordinated Debt shall for any reason be revoked or invalidated or otherwise cease to be in full force and effect, any Person shall be in breach thereof or contest in any manner the validity or enforceability thereof or deny that it has any further liability or obligation thereunder, or the Obligations shall for any reason be subordinated or shall not have the priority contemplated by this Agreement or the applicable subordination/intercreditor agreement;

 

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8.10 Guaranty . (a) Any guaranty of any Obligations terminates or ceases for any reason to be in full force and effect; (b) any Guarantor does not perform any obligation or covenant under any guaranty of the Obligations; (c) any circumstance described in Sections 8.3, 8.4, 8.5, 8.7, or 8.8 occurs with respect to any Guarantor, or (d) the death, liquidation, winding up, or termination of existence of any Guarantor; or (e) (i) a material impairment in the perfection or priority of Bank’s Lien in the collateral provided by Guarantor or in the value of such collateral or (ii) a material adverse change in the general affairs, management, results of operation, condition (financial or otherwise) or the prospect of repayment of the Obligations occurs with respect to any Guarantor; or

8.11 Governmental Approvals. Any Governmental Approval shall have been (a) revoked, rescinded, suspended, modified in an adverse manner or not renewed in the ordinary course for a full term or (b) subject to any decision by a Governmental Authority that designates a hearing with respect to any applications for renewal of any of such Governmental Approval or that could result in the Governmental Authority taking any of the actions described in clause (a) above, and such decision or such revocation, rescission, suspension, modification or non-renewal (i) cause, or could reasonably be expected to cause, a Material Adverse Change, or (ii) adversely affects the legal qualifications of Borrower or any of its Subsidiaries to hold such Governmental Approval in any applicable jurisdiction and such revocation, rescission, suspension, modification or non-renewal could reasonably be expected to affect the status of or legal qualifications of Borrower or any of its Subsidiaries to hold any Governmental Approval in any other jurisdiction.

 

  9

BANK’S RIGHTS AND REMEDIES

9.1 Rights and Remedies . Upon the occurrence and during the continuance of an Event of Default, Bank may, without notice or demand, do any or all of the following:

(a) declare all Obligations immediately due and payable (but if an Event of Default described in Section 8.5 occurs all Obligations are immediately due and payable without any action by Bank);

(b) stop advancing money or extending credit for Borrower’s benefit under this Agreement or under any other agreement between Borrower and Bank;

(c) demand with respect to any Letter of Credit issued for the account of Borrower by Bank, that Borrower (i) deposit cash with Bank in an amount equal to (x) if such Letters of Credit are denominated in Dollars, then at least one hundred five percent (105.0%); and (y) if such Letters of Credit are denominated in a Foreign Currency, then at least one hundred ten percent (110.0%), of the Dollar Equivalent of the aggregate face amount of all Letters of Credit remaining undrawn (plus all interest, fees, and costs due or to become due in connection therewith (as estimated by Bank in its good faith business judgment)), to secure all of the Obligations relating to such Letters of Credit, as collateral security for the repayment of any future drawings under such Letters of Credit, and Borrower shall forthwith deposit and pay such amounts, and (ii) pay in advance all letter of credit fees scheduled to be paid or payable over the remaining term of any Letters of Credit;

(d) terminate any FX Contracts;

(e) verify the amount of, demand payment of and performance under, and collect any Accounts and General Intangibles, settle or adjust disputes and claims directly with Account Debtors for amounts on terms and in any order that Bank considers advisable, and notify any Person owing Borrower money of Bank’s security interest in such funds;

(f) make any payments and do any acts it considers necessary or reasonable to protect the Collateral and/or its security interest in the Collateral. Borrower shall assemble the Collateral if Bank requests and make it available as Bank reasonably designates. Bank may enter premises where the Collateral is located, take and maintain possession of any part of the Collateral, and pay, purchase, contest, or compromise any Lien which appears to be prior or superior to its security interest and pay all expenses incurred. Borrower grants Bank a license to enter and occupy any of its premises, without charge, to exercise any of Bank’s rights or remedies;

 

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(g) apply to the Obligations any (i) balances and deposits of Borrower it holds, or (ii) any amount held by Bank owing to or for the credit or the account of Borrower;

(h) ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, advertise for sale, and sell the Collateral. Bank is hereby granted a non-exclusive, royalty-free license or other right to use, without charge, Borrower’s labels, Patents, Copyrights, mask works, rights of use of any name, trade secrets, trade names, Trademarks, and advertising matter, or any similar property as it pertains to the Collateral, which license rights shall be exercisable only after an Event of Default has occurred and is continuing, in completing production of, advertising for sale, and selling any Collateral and, in connection with Bank’s exercise of its rights under this Section, Borrower’s rights under all licenses and all franchise agreements inure to Bank’s benefit;

(i) place a “hold” on any account maintained with Bank and/or deliver a notice of exclusive control, any entitlement order, or other directions or instructions pursuant to any Control Agreement or similar agreements providing control of any Collateral;

(j) demand and receive possession of Borrower’s Books; and

(k) exercise all rights and remedies available to Bank under the Loan Documents or at law or equity, including all remedies provided under the Code (including disposal of the Collateral pursuant to the terms thereof).

9.2 Power of Attorney . Borrower hereby irrevocably appoints Bank as its lawful attorney-in-fact, exercisable upon the occurrence and during the continuance of an Event of Default, to: (a) endorse Borrower’s name on any checks or other forms of payment or security; (b) sign Borrower’s name on any invoice or bill of lading for any Account or drafts against Account Debtors; (c) settle and adjust disputes and claims about the Accounts directly with Account Debtors, for amounts and on terms Bank determines reasonable; (d) make, settle, and adjust all claims under Borrower’s insurance policies; (e) pay, contest or settle any Lien, charge, encumbrance, security interest, and adverse claim in or to the Collateral, or any judgment based thereon, or otherwise take any action to terminate or discharge the same; and (f) transfer the Collateral into the name of Bank or a third party as the Code permits. Borrower hereby appoints Bank as its lawful attorney-in-fact to sign Borrower’s name on any documents necessary to perfect or continue the perfection of Bank’s security interest in the Collateral regardless of whether an Event of Default has occurred until all Obligations (other than inchoate indemnity Obligations) have been satisfied in full and Bank is under no further obligation to make Credit Extensions hereunder. Bank’s foregoing appointment as Borrower’s attorney in fact, and all of Bank’s rights and powers, coupled with an interest, are irrevocable until all Obligations (other than inchoate indemnity Obligations) have been fully repaid and performed and Bank’s obligation to provide Credit Extensions terminates.

9.3 Protective Payments . If Borrower fails to obtain the insurance called for by Section 6.5 or fails to pay any premium thereon or fails to pay any other amount which Borrower is obligated to pay under this Agreement or any other Loan Document or which may be required to preserve the Collateral, Bank may obtain such insurance or make such payment, and all amounts so paid by Bank are Bank Expenses and immediately due and payable, bearing interest at the then highest rate applicable to the Obligations, and secured by the Collateral. Bank will make reasonable efforts to provide Borrower with notice of Bank obtaining such insurance at the time it is obtained or within a reasonable time thereafter. No payments by Bank are deemed an agreement to make similar payments in the future or Bank’s waiver of any Event of Default.

9.4 Application of Payments and Proceeds Upon Default . If an Event of Default has occurred and is continuing, Bank shall have the right to apply in any order any funds in its possession, whether from Borrower account balances, payments, proceeds realized as the result of any collection of Accounts or other disposition of the Collateral, or otherwise, to the Obligations. Bank shall pay any surplus to Borrower by credit to the Designated Deposit Account or to other Persons legally entitled thereto; Borrower shall remain liable to Bank for any deficiency. If Bank, directly or indirectly, enters into a deferred payment or other credit transaction with any purchaser at any sale of Collateral, Bank shall have the option, exercisable at any time, of either reducing the Obligations by the principal amount of the purchase price or deferring the reduction of the Obligations until the actual receipt by Bank of cash therefor.

 

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9.5 Bank’s Liability for Collateral . So long as Bank complies with reasonable banking practices regarding the safekeeping of the Collateral in the possession or under the control of Bank, Bank shall not be liable or responsible for: (a) the safekeeping of the Collateral; (b) any loss or damage to the Collateral; (c) any diminution in the value of the Collateral; or (d) any act or default of any carrier, warehouseman, bailee, or other Person. Borrower bears all risk of loss, damage or destruction of the Collateral.

9.6 No Waiver; Remedies Cumulative . Bank’s failure, at any time or times, to require strict performance by Borrower of any provision of this Agreement or any other Loan Document shall not waive, affect, or diminish any right of Bank thereafter to demand strict performance and compliance herewith or therewith. No waiver hereunder shall be effective unless signed by the party granting the waiver and then is only effective for the specific instance and purpose for which it is given. Bank’s rights and remedies under this Agreement and the other Loan Documents are cumulative. Bank has all rights and remedies provided under the Code, by law, or in equity. Bank’s exercise of one right or remedy is not an election and shall not preclude Bank from exercising any other remedy under this Agreement or other remedy available at law or in equity, and Bank’s waiver of any Event of Default is not a continuing waiver. Bank’s delay in exercising any remedy is not a waiver, election, or acquiescence.

9.7 Demand Waiver . Borrower waives demand, notice of default or dishonor, notice of payment and nonpayment, notice of any default, nonpayment at maturity, release, compromise, settlement, extension, or renewal of accounts, documents, instruments, chattel paper, and guarantees held by Bank on which Borrower is liable.

 

  10

NOTICES

All notices, consents, requests, approvals, demands, or other communication by any party to this Agreement or any other Loan Document must be in writing and shall be deemed to have been validly served, given, or delivered: (a) upon the earlier of actual receipt and three (3) Business Days after deposit in the U.S. mail, first class, registered or certified mail return receipt requested, with proper postage prepaid; (b) upon transmission, when sent by electronic mail or facsimile transmission; (c) one (1) Business Day after deposit with a reputable overnight courier with all charges prepaid; or (d) when delivered, if hand-delivered by messenger, all of which shall be addressed to the party to be notified and sent to the address, facsimile number, or email address indicated below. Bank or Borrower may change its mailing or electronic mail address or facsimile number by giving the other party written notice thereof in accordance with the terms of this Section 10.

 

If to Borrower:

  

SIERRA ONCOLOGY, INC.

885 West Georgia Street, Suite 2150

Vancouver, BC V6C 3E8, Canada

Attn: Sukhi Jagpal, CFO

Email: XXXXXXXXX

If to Bank:

  

SILICON VALLEY BANK

505 Howard Street, Third Floor

San Francisco, CA 94105

Attn: Peter Sletteland

Email: XXXXXXXXX

 

  11

CHOICE OF LAW, VENUE, JURY TRIAL WAIVER, AND JUDICIAL REFERENCE

Except as otherwise expressly provided in any of the Loan Documents, California law governs the Loan Documents without regard to principles of conflicts of law. Borrower and Bank each submit to the exclusive jurisdiction of the State and Federal courts in Santa Clara County, California; provided, however, that nothing in this Agreement shall be deemed to operate to preclude Bank from bringing suit or taking other legal action in any other jurisdiction to realize on the Collateral or any other security for the Obligations, or to enforce a judgment or other court order in favor of Bank. Borrower expressly submits and consents in advance to such jurisdiction in any action or suit commenced in any such court, and Borrower hereby waives any objection that it may have based upon lack

 

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of personal jurisdiction, improper venue, or forum non conveniens and hereby consents to the granting of such legal or equitable relief as is deemed appropriate by such court. Borrower hereby waives personal service of the summons, complaints, and other process issued in such action or suit and agrees that service of such summons, complaints, and other process may be made by registered or certified mail addressed to Borrower at the address set forth in, or subsequently provided by Borrower in accordance with, Section 10 of this Agreement and that service so made shall be deemed completed upon the earlier to occur of Borrower’s actual receipt thereof or five (5) days after deposit in the U.S. mails, properly addressed and with proper postage prepaid.

TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, BORROWER AND BANK EACH WAIVE THEIR RIGHT TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION ARISING OUT OF OR BASED UPON THIS AGREEMENT, THE LOAN DOCUMENTS OR ANY CONTEMPLATED TRANSACTION, INCLUDING CONTRACT, TORT, BREACH OF DUTY AND ALL OTHER CLAIMS. THIS WAIVER IS A MATERIAL INDUCEMENT FOR BOTH PARTIES TO ENTER INTO THIS AGREEMENT. EACH PARTY HAS REVIEWED THIS WAIVER WITH ITS COUNSEL.

WITHOUT INTENDING IN ANY WAY TO LIMIT THE PARTIES’ AGREEMENT TO WAIVE THEIR RESPECTIVE RIGHT TO A TRIAL BY JURY, if the above waiver of the right to a trial by jury is not enforceable, the parties hereto agree that any and all disputes or controversies of any nature between them arising at any time shall be decided by a reference to a private judge, mutually selected by the parties (or, if they cannot agree, by the Presiding Judge of the Santa Clara County, California Superior Court) appointed in accordance with California Code of Civil Procedure Section 638 (or pursuant to comparable provisions of federal law if the dispute falls within the exclusive jurisdiction of the federal courts), sitting without a jury, in Santa Clara County, California; and the parties hereby submit to the jurisdiction of such court. The reference proceedings shall be conducted pursuant to and in accordance with the provisions of California Code of Civil Procedure §§ 638 through 645.1, inclusive. The private judge shall have the power, among others, to grant provisional relief, including without limitation, entering temporary restraining orders, issuing preliminary and permanent injunctions and appointing receivers. All such proceedings shall be closed to the public and confidential and all records relating thereto shall be permanently sealed. If during the course of any dispute, a party desires to seek provisional relief, but a judge has not been appointed at that point pursuant to the judicial reference procedures, then such party may apply to the Santa Clara County, California Superior Court for such relief. The proceeding before the private judge shall be conducted in the same manner as it would be before a court under the rules of evidence applicable to judicial proceedings. The parties shall be entitled to discovery which shall be conducted in the same manner as it would be before a court under the rules of discovery applicable to judicial proceedings. The private judge shall oversee discovery and may enforce all discovery rules and orders applicable to judicial proceedings in the same manner as a trial court judge. The parties agree that the selected or appointed private judge shall have the power to decide all issues in the action or proceeding, whether of fact or of law, and shall report a statement of decision thereon pursuant to California Code of Civil Procedure § 644(a). Nothing in this paragraph shall limit the right of any party at any time to exercise self-help remedies, foreclose against collateral, or obtain provisional remedies. The private judge shall also determine all issues relating to the applicability, interpretation, and enforceability of this paragraph.

This Section 11 shall survive the termination of this Agreement.

 

  12

GENERAL PROVISIONS

12.1 Termination; Survival . All covenants, representations and warranties made in this Agreement continue in full force until this Agreement has terminated pursuant to its terms and all Obligations have been satisfied. At the time when (i) Borrower has satisfied the Obligations (other than inchoate indemnity obligations and any other obligations which, by their terms, are to survive the termination of this Agreement, and any Obligations under Bank Services Agreements that are cash collateralized in accordance with Section 4.1 of this Agreement) and (ii) Bank has no further obligation to make Credit Extensions hereunder, this Agreement shall terminate and so long as Borrower complies with clause (i) of this Section, this Agreement may be terminated prior to the Growth Capital Maturity Date by Borrower, effective three (3) Business Days after written notice of termination is given to Bank. Those obligations that are expressly specified in this Agreement as surviving this Agreement’s termination shall continue to survive notwithstanding this Agreement’s termination. Upon the termination of this Agreement, Bank, at Borrower’s expense, shall execute such documents and take such further steps as Borrower shall request to terminate public filings or otherwise evidence the termination of the security interest granted to Bank pursuant to this Agreement.

 

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12.2 Successors and Assigns . This Agreement binds and is for the benefit of the successors and permitted assigns of each party. Borrower may not assign this Agreement or any rights or obligations under it without Bank’s prior written consent (which may be granted or withheld in Bank’s discretion). Bank has the right, without the consent of or notice to Borrower, to sell, transfer, assign, negotiate, or grant participation in all or any part of, or any interest in, Bank’s obligations, rights, and benefits under this Agreement and the other Loan Documents (other than the Warrant, as to which assignment, transfer and other such actions are governed by the terms thereof).

12.3 Indemnification . Borrower agrees to indemnify, defend and hold Bank and its directors, officers, employees, agents, attorneys, or any other Person affiliated with or representing Bank (each, an “ Indemnified Person ”) harmless against: (i) all obligations, demands, claims, and liabilities (collectively, “ Claims ”) claimed or asserted by any other party in connection with the transactions contemplated by the Loan Documents; and (ii) all losses or expenses (including Bank Expenses) in any way suffered, incurred, or paid by such Indemnified Person as a result of, following from, consequential to, or arising from transactions between Bank and Borrower (including reasonable attorneys’ fees and expenses), except for Claims and/or losses directly caused by such Indemnified Person’s gross negligence or willful misconduct.

This Section 12.3 shall survive until all statutes of limitation with respect to the Claims, losses, and expenses for which indemnity is given shall have run.

12.4 Time of Essence . Time is of the essence for the performance of all Obligations in this Agreement.

12.5 Severability of Provisions . Each provision of this Agreement is severable from every other provision in determining the enforceability of any provision.

12.6 Correction of Loan Documents . Bank may correct patent errors and fill in any blanks in the Loan Documents consistent with the agreement of the parties.

12.7 Amendments in Writing; Waiver; Integration . No purported amendment or modification of any Loan Document, or waiver, discharge or termination of any obligation under any Loan Document, shall be enforceable or admissible unless, and only to the extent, expressly set forth in a writing signed by the party against which enforcement or admission is sought. Without limiting the generality of the foregoing, no oral promise or statement, nor any action, inaction, delay, failure to require performance or course of conduct shall operate as, or evidence, an amendment, supplement or waiver or have any other effect on any Loan Document. Any waiver granted shall be limited to the specific circumstance expressly described in it, and shall not apply to any subsequent or other circumstance, whether similar or dissimilar, or give rise to, or evidence, any obligation or commitment to grant any further waiver. The Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements. All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of the Loan Documents merge into the Loan Documents.

12.8 Counterparts . This Agreement may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when executed and delivered, is an original, and all taken together, constitute one Agreement.

12.9 Confidentiality . In handling any confidential information, Bank shall exercise the same degree of care that it exercises for its own proprietary information, but disclosure of information may be made: (a) to Bank’s Subsidiaries or Affiliates (such Subsidiaries and Affiliates, together with Bank, collectively, “ Bank Entities ”); (b) to prospective transferees or purchasers of any interest in the Credit Extensions (provided, however, Bank shall use its best efforts to obtain any prospective transferee’s or purchaser’s agreement to the terms of this provision); (c) as required by law, regulation, subpoena, or other order; (d) to Bank’s regulators or as otherwise required in connection with Bank’s examination or audit; (e) as Bank considers appropriate in exercising remedies under the Loan Documents; and (f) to third-party service providers of Bank so long as such service providers have executed a

 

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confidentiality agreement with Bank with terms no less restrictive than those contained herein. Confidential information does not include information that is either: (i) in the public domain or in Bank’s possession when disclosed to Bank, or becomes part of the public domain (other than as a result of its disclosure by Bank in violation of this Agreement) after disclosure to Bank; or (ii) disclosed to Bank by a third party, if Bank does not know that the third party is prohibited from disclosing the information.

Bank Entities may use anonymous forms of confidential information for aggregate datasets, for analyses or reporting, and for any other uses not expressly prohibited in writing by Borrower. The provisions of the immediately preceding sentence shall survive termination of this Agreement.

12.10 Attorneys’ Fees, Costs and Expenses . In any action or proceeding between Borrower and Bank arising out of or relating to the Loan Documents, the prevailing party shall be entitled to recover its reasonable attorneys’ fees and other costs and expenses incurred, in addition to any other relief to which it may be entitled.

12.11 Electronic Execution of Documents . The words “execution,” “signed,” “signature” and words of like import in any Loan Document shall be deemed to include electronic signatures or the keeping of records in electronic form, each of which shall be of the same legal effect, validity and enforceability as a manually executed signature or the use of a paper-based recordkeeping systems, as the case may be, to the extent and as provided for in any applicable law, including, without limitation, any state law based on the Uniform Electronic Transactions Act.

12.12 Captions . The headings used in this Agreement are for convenience only and shall not affect the interpretation of this Agreement.

12.13 Construction of Agreement . The parties mutually acknowledge that they and their attorneys have participated in the preparation and negotiation of this Agreement. In cases of uncertainty this Agreement shall be construed without regard to which of the parties caused the uncertainty to exist.

12.14 Relationship . The relationship of the parties to this Agreement is determined solely by the provisions of this Agreement. The parties do not intend to create any agency, partnership, joint venture, trust, fiduciary or other relationship with duties or incidents different from those of parties to an arm’s-length contract.

12.15 Third Parties . Nothing in this Agreement, whether express or implied, is intended to: (a) confer any benefits, rights or remedies under or by reason of this Agreement on any persons other than the express parties to it and their respective permitted successors and assigns; (b) relieve or discharge the obligation or liability of any person not an express party to this Agreement; or (c) give any person not an express party to this Agreement any right of subrogation or action against any party to this Agreement.

 

  13

DEFINITIONS

13.1 Definitions . As used in the Loan Documents, the word “shall” is mandatory, the word “may” is permissive, the word “or” is not exclusive, the words “includes” and “including” are not limiting, the singular includes the plural, and numbers denoting amounts that are set off in brackets are negative. As used in this Agreement, the following capitalized terms have the following meanings:

Account ” is any “account” as defined in the Code with such additions to such term as may hereafter be made, and includes, without limitation, all accounts receivable and other sums owing to Borrower.

Account Debtor ” is any “account debtor” as defined in the Code with such additions to such term as may hereafter be made.

Affiliate ” is, with respect to any Person, each other Person that owns or controls directly or indirectly the Person, any Person that controls or is controlled by or is under common control with the Person, and each of that Person’s senior executive officers, directors, partners and, for any Person that is a limited liability company, that Person’s managers and members.

 

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Agreement ” is defined in the preamble hereof.

Amortization Start Date ” is March 1, 2020; provided, however, if Borrower achieves the Equity Event, the Amortization Start Date shall automatically, with no further action required by the parties hereto, be extended to September 1, 2020.

Authorized Signer ” is any individual listed in Borrower’s Borrowing Resolution who is authorized to execute the Loan Documents on behalf of Borrower.

Bank ” is defined in the preamble hereof.

Bank Entities ” is defined in Section 12.9.

Bank Expenses ” are all audit fees and expenses, costs, and expenses (including reasonable attorneys’ fees and expenses) for preparing, amending, negotiating, administering, defending and enforcing the Loan Documents (including, without limitation, those incurred in connection with appeals or Insolvency Proceedings) or otherwise incurred with respect to Borrower or any Guarantor.

Bank Services ” are any products, credit services, and/or financial accommodations previously, now, or hereafter provided to Borrower or any of its Subsidiaries by Bank or any Bank Affiliate, including, without limitation, any Letters of Credit, cash management services (including, without limitation, merchant services, direct deposit of payroll, business credit cards, and check cashing services), interest rate swap arrangements, and foreign exchange services as any such products or services may be identified in Bank’s various agreements related thereto (each, a “ Bank Services Agreement ”).

Borrower ” is defined in the preamble hereof.

Borrower’s Books ” are all Borrower’s books and records including ledgers, federal and state tax returns, records regarding Borrower’s assets or liabilities, the Collateral, business operations or financial condition, and all computer programs or storage or any equipment containing such information.

Borrowing Resolutions ” are, with respect to any Person, those resolutions substantially in the form attached hereto as Exhibit D .

Business Day ” is any day that is not a Saturday, Sunday or a day on which Bank is closed.

Cash Equivalents ” means (a) marketable direct obligations issued or unconditionally guaranteed by the United States or any agency or any State thereof having maturities of not more than one (1) year from the date of acquisition; (b) commercial paper maturing no more than one (1) year after its creation and having the highest rating from either Standard & Poor’s Ratings Group or Moody’s Investors Service, Inc.; (c) Bank’s certificates of deposit issued maturing no more than one (1) year after issue; and (d) money market funds at least ninety-five percent (95%) of the assets of which constitute Cash Equivalents of the kinds described in clauses (a) through (c) of this definition.

Change in Control ” means (a) at any time, any “person” or “group” (as such terms are used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”)), shall become, or obtain rights (whether by means or warrants, options or otherwise) to become, the “beneficial owner” (as defined in Rules 13(d)-3 and 13(d)-5 under the Exchange Act), directly or indirectly, of forty-nine percent (49%) or more of the ordinary voting power for the election of directors of Borrower (determined on a fully diluted basis) other than by the sale of Borrower’s equity securities in a public offering or to venture capital or private equity investors so long as Borrower identifies to Bank the venture capital or private equity investors at least seven (7) Business Days prior to the closing of the transaction and provides to Bank a description of the material terms of the transaction; (b) during any period of twelve (12) consecutive months, a majority of the members of the board of directors or other equivalent governing body of Borrower cease to be composed of individuals (i) who were members of that board or equivalent governing body on the first day of such period, (ii) whose election or nomination to that board or equivalent governing body was approved by individuals referred to in clause (i) above constituting at the time of

 

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such election or nomination at least a majority of that board or equivalent governing body or (iii) whose election or nomination to that board or other equivalent governing body was approved by individuals referred to in clauses (i) and (ii) above constituting at the time of such election or nomination at least a majority of that board or equivalent governing body; or (c) at any time, Borrower shall cease to own and control, of record and beneficially, directly or indirectly, one hundred percent (100%) of each class of outstanding capital stock of each subsidiary of Borrower free and clear of all Liens (except Liens created by this Agreement).

Claims ” is defined in Section 12.3.

Code ” is the Uniform Commercial Code, as the same may, from time to time, be enacted and in effect in the State of California; provided, that, to the extent that the Code is used to define any term herein or in any Loan Document and such term is defined differently in different Articles or Divisions of the Code, the definition of such term contained in Article or Division 9 shall govern; provided further, that in the event that, by reason of mandatory provisions of law, any or all of the attachment, perfection, or priority of, or remedies with respect to, Bank’s Lien on any Collateral is governed by the Uniform Commercial Code in effect in a jurisdiction other than the State of California, the term “ Code ” shall mean the Uniform Commercial Code as enacted and in effect in such other jurisdiction solely for purposes of the provisions thereof relating to such attachment, perfection, priority, or remedies and for purposes of definitions relating to such provisions.

Collateral ” is any and all properties, rights and assets of Borrower described on Exhibit A .

Collateral Account ” is any Deposit Account, Securities Account, or Commodity Account.

Commodity Account ” is any “commodity account” as defined in the Code with such additions to such term as may hereafter be made.

Compliance Statement ” is that certain certificate in the form attached hereto as Exhibit B .

Contingent Obligation ” is, for any Person, any direct or indirect liability, contingent or not, of that Person for (a) any indebtedness, lease, dividend, letter of credit or other obligation of another such as an obligation, in each case, directly or indirectly guaranteed, endorsed, co-made, discounted or sold with recourse by that Person, or for which that Person is directly or indirectly liable; (b) any obligations for undrawn Letters of Credit for the account of that Person; and (c) all obligations from any interest rate, currency or commodity swap agreement, interest rate cap or collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; but “Contingent Obligation” does not include endorsements in the ordinary course of business. The amount of a Contingent Obligation is the stated or determined amount of the primary obligation for which the Contingent Obligation is made or, if not determinable, the maximum reasonably anticipated liability for it determined by the Person in good faith; but the amount may not exceed the maximum of the obligations under any guarantee or other support arrangement.

Control Agreement ” is any control agreement entered into among the depository institution at which Borrower maintains a Deposit Account or the securities intermediary or commodity intermediary at which Borrower maintains a Securities Account or a Commodity Account, Borrower, and Bank pursuant to which Bank obtains control (within the meaning of the Code) over such Deposit Account, Securities Account, or Commodity Account.

Copyrights ” are any and all copyright rights, copyright applications, copyright registrations and like protections in each work of authorship and derivative work thereof, whether published or unpublished and whether or not the same also constitutes a trade secret.

Credit Extension ” is any Growth Capital Advance, Letter of Credit, FX Contract, amount utilized for cash management services, or any other extension of credit by Bank for Borrower’s benefit.

Default Rate ” is defined in Section 2.3(b).

 

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Deposit Account ” is any “deposit account” as defined in the Code with such additions to such term as may hereafter be made.

Designated Deposit Account ” is the multicurrency account denominated in Dollars, account number xxx-xxxx-330, maintained by Borrower with Bank.

Dollars , ” “ dollars ” or use of the sign “ $ ” means only lawful money of the United States and not any other currency, regardless of whether that currency uses the “$” sign to denote its currency or may be readily converted into lawful money of the United States.

Dollar Equivalent ” is, at any time, (a) with respect to any amount denominated in Dollars, such amount, and (b) with respect to any amount denominated in a Foreign Currency, the equivalent amount therefor in Dollars as determined by Bank at such time on the basis of the then-prevailing rate of exchange in San Francisco, California, for sales of the Foreign Currency for transfer to the country issuing such Foreign Currency.

Domestic Subsidiary ” means a Subsidiary formed under the laws of the United States of America, of any State thereof or of the District of Columbia.

Effective Date ” is defined in the preamble hereof.

Equipment ” is all “equipment” as defined in the Code with such additions to such term as may hereafter be made, and includes without limitation all machinery, fixtures, goods, vehicles (including motor vehicles and trailers), and any interest in any of the foregoing.

Equity Event ” means Borrower’s delivery to Bank of evidence, in form and substance satisfactory to Bank in its sole discretion, confirming that Borrower has received, after the Effective Date but on or prior to December 31, 2019, net cash proceeds in an aggregate amount not less than Fifty Million Dollars ($50,000,000) from the sale of Borrower’s equity securities.

ERISA ” is the Employee Retirement Income Security Act of 1974, and its regulations.

Event of Default ” is defined in Section 8.

Exchange Act ” is the Securities Exchange Act of 1934, as amended.

Final Payment ” is a payment (in addition to and not a substitution for the regular monthly payments of principal plus accrued interest) due on the earliest to occur of (a) the Growth Capital Maturity Date, (b) prepayment of the Growth Capital Advances, or (c) termination of the Growth Capital Line for any reason prior to the Growth Capital Maturity Date, in an amount equal to the original aggregate principal amount of all Growth Capital Advances made by Bank to Borrower multiplied by six and three quarters of one percentage points (6.75%).

Financial Statement Repository ” is LifeScienceReporting@svb.com or such other means of collecting information approved and designated by Bank after providing notice thereof to Borrower from time to time.

Foreign Currency ” means lawful money of a country other than the United States.

Foreign Subsidiary ” means a Subsidiary which is not a Domestic Subsidiary.

Funding Date ” is any date on which a Credit Extension is made to or for the account of Borrower which shall be a Business Day.

FX Contract ” is any foreign exchange contract by and between Borrower and Bank under which Borrower commits to purchase from or sell to Bank a specific amount of Foreign Currency on a specified date.

 

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GAAP ” is generally accepted accounting principles set forth in the opinions and pronouncements of the Accounting Principles Board of the American Institute of Certified Public Accountants and statements and pronouncements of the Financial Accounting Standards Board or in such other statements by such other Person as may be approved by a significant segment of the accounting profession, which are applicable to the circumstances as of the date of determination.

General Intangibles ” is all “general intangibles” as defined in the Code in effect on the date hereof with such additions to such term as may hereafter be made, and includes without limitation, all Intellectual Property, claims, income and other tax refunds, security and other deposits, payment intangibles, contract rights, options to purchase or sell real or personal property, rights in all litigation presently or hereafter pending (whether in contract, tort or otherwise), insurance policies (including without limitation key man, property damage, and business interruption insurance), payments of insurance and rights to payment of any kind.

Governmental Approval ” is any consent, authorization, approval, order, license, franchise, permit, certificate, accreditation, registration, filing or notice, of, issued by, from or to, or other act by or in respect of, any Governmental Authority.

Governmental Authority ” is any nation or government, any state or other political subdivision thereof, any agency, authority, instrumentality, regulatory body, court, central bank or other entity exercising executive, legislative, judicial, taxing, regulatory or administrative functions of or pertaining to government, any securities exchange and any self-regulatory organization.

Growth Capital Advance ” and “ Growth Capital Advances ” are defined in Section 2.1.1(a).

Growth Capital Advance Payment ” is defined in Section 2.1.1(b).

Growth Capital Line ” is a Growth Capital Advance or Growth Capital Advances in an aggregate principal amount of up to Fifteen Million Dollars ($15,000,000).

Growth Capital Maturity Date ” is August 1, 2022.

Guarantor ” is any Person providing a Guaranty in favor of Bank.

Guaranty ” is any guarantee of all or any part of the Obligations, as the same may from time to time be amended, restated, modified or otherwise supplemented.

Indebtedness ” is (a) indebtedness for borrowed money or the deferred price of property or services, such as reimbursement and other obligations for surety bonds and Letters of Credit, (b) obligations evidenced by notes, bonds, debentures or similar instruments, (c) capital lease obligations, and (d) Contingent Obligations.

Indemnified Person ” is defined in Section 12.3.

Insolvency Proceeding” is any proceeding by or against any Person under the United States Bankruptcy Code, or any other bankruptcy or insolvency law, including assignments for the benefit of creditors, compositions, extensions generally with its creditors, or proceedings seeking reorganization, arrangement, or other relief.

Intellectual Property ” means, with respect to any Person, means all of such Person’s right, title, and interest in and to the following:

(a) its Copyrights, Trademarks and Patents;

(b) any and all trade secrets and trade secret rights, including, without limitation, any rights to unpatented inventions, know-how, operating manuals;

(c) any and all source code;

 

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(d) any and all design rights which may be available to such Person;

(e) any and all claims for damages by way of past, present and future infringement of any of the foregoing, with the right, but not the obligation, to sue for and collect such damages for said use or infringement of the Intellectual Property rights identified above; and

(f) all amendments, renewals and extensions of any of the Copyrights, Trademarks or Patents.

Interest-Only Period ” is the period of time from the Effective Date through February 29, 2020; provided, however, if Borrower achieves the Equity Event, then the Interest-Only Period shall automatically, with no further action required by the parties hereto, be extended through August 31, 2020.

Inventory ” is all “inventory” as defined in the Code in effect on the date hereof with such additions to such term as may hereafter be made, and includes without limitation all merchandise, raw materials, parts, supplies, packing and shipping materials, work in process and finished products, including without limitation such inventory as is temporarily out of Borrower’s custody or possession or in transit and including any returned goods and any documents of title representing any of the above.

Investment ” is any beneficial ownership interest in any Person (including stock, partnership interest or other securities), and any loan, advance or capital contribution to any Person.

Key Person ” is each of Borrower’s (a) Chief Executive Officer, who is Nick Glover as of the Effective Date, and (b) Chief Financial Officer, who is Sukhi Jagpal as of the Effective Date.

Letter of Credit ” is a standby or commercial letter of credit issued by Bank upon request of Borrower based upon an application, guarantee, indemnity, or similar agreement.

Lien ” is a claim, mortgage, deed of trust, levy, charge, pledge, security interest or other encumbrance of any kind, whether voluntarily incurred or arising by operation of law or otherwise against any property.

Loan Documents ” are, collectively, this Agreement and any schedules, exhibits, certificates, notices, and any other documents related to this Agreement, the Warrant, any Bank Services Agreement, any subordination agreement, any note, or notes or guaranties executed by Borrower or any Guarantor, and any other present or future agreement by Borrower and/or any Guarantor with or for the benefit of Bank in connection with this Agreement or Bank Services, all as amended, restated, or otherwise modified.

Material Adverse Change ” is (a) a material impairment in the perfection or priority of Bank’s Lien in the Collateral or in the value of such Collateral; (b) a material adverse change in the business, operations, or condition (financial or otherwise) of Borrower; or (c) a material impairment of the prospect of repayment of any portion of the Obligations.

Monthly Cash Statements ” is defined in Section 6.2(a).

Obligations ” are Borrower’s obligations to pay when due any debts, principal, interest, fees, Bank Expenses, the Prepayment Fee, the Final Payment, and other amounts Borrower owes Bank now or later, whether under this Agreement, the other Loan Documents (other than the Warrant), or otherwise, including, without limitation, all obligations relating to Letters of Credit (including reimbursement obligations for drawn and undrawn Letters of Credit), cash management services, and foreign exchange contracts, if any, and including interest accruing after Insolvency Proceedings begin and debts, liabilities, or obligations of Borrower assigned to Bank, and to perform Borrower’s duties under the Loan Documents (other than the Warrant).

Operating Documents ” are, for any Person, such Person’s formation documents, as certified by the Secretary of State (or equivalent agency) of such Person’s jurisdiction of organization on a date that is no earlier than thirty (30) days prior to the Effective Date, and, (a) if such Person is a corporation, its bylaws in current form,

 

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(b) if such Person is a limited liability company, its limited liability company agreement (or similar agreement), and (c) if such Person is a partnership, its partnership agreement (or similar agreement), each of the foregoing with all current amendments or modifications thereto.

Patents ” means all patents, patent applications and like protections including without limitation improvements, divisions, continuations, renewals, reissues, extensions and continuations-in-part of the same.

Payment/Advance Form ” is that certain form attached hereto as Exhibit C .

Perfection Certificate ” is defined in Section 5.1.

“Permitted Indebtedness” is:

(a) Borrower’s Indebtedness to Bank under this Agreement and the other Loan Documents;

(b) Indebtedness existing on the Effective Date and shown on the Perfection Certificate;

(c) Subordinated Debt;

(d) unsecured Indebtedness to trade creditors incurred in the ordinary course of business;

(e) Indebtedness incurred as a result of endorsing negotiable instruments received in the ordinary course of business;

(f) Indebtedness secured by Liens permitted under clauses (a) and (c) of the definition of “Permitted Liens” hereunder;

(g) up to Three Hundred Thousand Dollars ($300,000) of Indebtedness in favor of XXX Bank incurred in connection with corporate credit cards provided by XXX Bank in favor of Borrower; and

(h) extensions, refinancings, modifications, amendments and restatements of any items of Permitted Indebtedness (a) through (g) above, provided that the principal amount thereof is not increased or the terms thereof are not modified to impose more burdensome terms upon Borrower or its Subsidiary, as the case may be.

“Permitted Investments” are:

(a) Investments (including, without limitation, Subsidiaries) existing on the Effective Date and shown on the Perfection Certificate;

(b) Investments consisting of Cash Equivalents;

(c) Investments consisting of the endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of Borrower;

(d) Investments consisting of deposit accounts in which Bank has a perfected security interest;

(e) Investments accepted in connection with Transfers permitted by Section 7.1;

(f) Investments by Borrower in Sierra Oncology Canada, LLC not to exceed Fifty Thousand Dollars ($50,000) in the aggregate in any fiscal year;

(g) Investments by Borrower in Sierra Oncology Canada ULC subject to the terms and conditions set forth in Section 6.6(a) and Section 7.11 hereof;

 

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(h) Investments by Subsidiaries in other Subsidiaries not to exceed One Hundred Thousand Dollars ($100,000) in the aggregate in any fiscal year or in Borrower;

(i) Investments consisting of (i) travel advances and employee relocation loans and other employee loans and advances in the ordinary course of business, and (ii) loans to employees, officers or directors relating to the purchase of equity securities of Borrower or its Subsidiaries pursuant to employee stock purchase plans or agreements approved by Borrower’s board of directors;

(j) Investments (including debt obligations) received in connection with the bankruptcy or reorganization of customers or suppliers and in settlement of delinquent obligations of, and other disputes with, customers or suppliers arising in the ordinary course of business; and

(k) Investments consisting of notes receivable of, or prepaid royalties and other credit extensions, to customers and suppliers who are not Affiliates, in the ordinary course of business; provided that this paragraph (l) shall not apply to Investments of Borrower in any Subsidiary.

“Permitted Liens” are:

(a) Liens existing on the Effective Date and shown on the Perfection Certificate or arising under this Agreement and the other Loan Documents;

(b) Liens for taxes, fees, assessments or other government charges or levies, either (i) not due and payable or (ii) being contested in good faith and for which Borrower maintains adequate reserves on its Books, provided that no notice of any such Lien has been filed or recorded under the Internal Revenue Code of 1986, as amended, and the Treasury Regulations adopted thereunder;

(c) purchase money Liens (i) on Equipment acquired or held by Borrower incurred for financing the acquisition of the Equipment securing no more than One Hundred Thousand Dollars ($100,000) in the aggregate amount outstanding, or (ii) existing on Equipment when acquired, if the Lien is confined to the property and improvements and the proceeds of the Equipment;

(d) Liens of carriers, warehousemen, suppliers, or other Persons that are possessory in nature arising in the ordinary course of business so long as such Liens attach only to Inventory, securing liabilities in the aggregate amount not to exceed Twenty-Five Thousand Dollars ($25,000), and which are not delinquent or remain payable without penalty or which are being contested in good faith and by appropriate proceedings which proceedings have the effect of preventing the forfeiture or sale of the property subject thereto;

(e) Liens to secure payment of workers’ compensation, employment insurance, old-age pensions, social security and other like obligations incurred in the ordinary course of business (other than Liens imposed by ERISA);

(f) Liens incurred in the extension, renewal or refinancing of the indebtedness secured by Liens described in (a) through (c), but any extension, renewal or replacement Lien must be limited to the property encumbered by the existing Lien and the principal amount of the indebtedness may not increase;

(g) leases or subleases of real property granted in the ordinary course of Borrower’s business (or, if referring to another Person, in the ordinary course of such Person’s business), and leases, subleases, non-exclusive licenses or sublicenses of personal property (other than Intellectual Property) granted in the ordinary course of Borrower’s business (or, if referring to another Person, in the ordinary course of such Person’s business), if the leases, subleases, licenses and sublicenses do not prohibit granting Bank a security interest therein;

(h) non-exclusive license of Intellectual Property granted to third parties in the ordinary course of business, and licenses of Intellectual Property that could not result in a legal transfer of title of the licensed property that may be exclusive in respects other than territory and that may be exclusive as to territory only as to discreet geographical territories outside of the United States;

 

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(i) Liens in favor of XXX Bank on that certain cash Collateral in Borrower’s account no. XXXXXXXXXX, at XXX Bank, securing up to Three Hundred Thousand Dollars ($300,000) of Indebtedness incurred in connection with the corporate credit cards issued by XXX Bank to Borrower; and

(j) Liens arising from attachments or judgments, orders, or decrees in circumstances not constituting an Event of Default under Sections 8.4 and 8.7.

Person ” is any individual, sole proprietorship, partnership, limited liability company, joint venture, company, trust, unincorporated organization, association, corporation, institution, public benefit corporation, firm, joint stock company, estate, entity or government agency.

[***] Milestone ” means Borrower’s delivery of evidence satisfactory to Bank in its sole discretion, confirming that Borrower has [***].

[***].

[***] Milestone ” means Borrower’s delivery of evidence satisfactory to Bank in its sole discretion, confirming that Borrower has [***].

[***].

Prepayment Fee ” means a fee due upon prepayment (whether voluntary or otherwise) of the Growth Capital Advances equal to (i) three percent (3.00%) of the outstanding principal balance of the Growth Capital Advances if such prepayment occurs prior to the first anniversary of the Effective Date, (ii) two percent (2.00%) of the outstanding principal balance of the Growth Capital Advances if such prepayment occurs on or after the first anniversary of the Effective Date, but prior to the second anniversary of the Effective Date, or (iii) one percent (1.00%) of the outstanding principal balance of Growth Capital Advances if such prepayment occurs on the second anniversary of the Effective Date or at any time thereafter prior to the Growth Capital Maturity Date.

Prime Rate ” is the rate of interest per annum from time to time published in the money rates section of The Wall Street Journal or any successor publication thereto as the “prime rate” then in effect; provided that, in the event such rate of interest is less than zero, such rate shall be deemed to be zero for purposes of this Agreement; and provided further that if such rate of interest, as set forth from time to time in the money rates section of The Wall Street Journal, becomes unavailable for any reason as determined by Bank, the “Prime Rate” shall mean the rate of interest per annum announced by Bank as its prime rate in effect at its principal office in the State of California (such Bank announced Prime Rate not being intended to be the lowest rate of interest charged by Bank in connection with extensions of credit to debtors); provided that, in the event such rate of interest is less than zero, such rate shall be deemed to be zero for purposes of this Agreement.

Registered Organization ” is any “registered organization” as defined in the Code with such additions to such term as may hereafter be made.

Requirement of Law ” is as to any Person, the organizational or governing documents of such Person, and any law (statutory or common), treaty, rule or regulation or determination of an arbitrator or a court or other Governmental Authority, in each case applicable to or binding upon such Person or any of its property or to which such Person or any of its property is subject.

Responsible Officer ” is any of the Chief Executive Officer or President, Chief Financial Officer of Borrower.

Restricted License ” is any material license or other agreement with respect to which Borrower is the licensee (a) that prohibits or otherwise restricts Borrower from granting a security interest in Borrower’s interest in such license or agreement or any other property, or (b) for which a default under or termination of could interfere with Bank’s right to sell any Collateral.

 

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*** Confidential Treatment Requested.


SEC ” shall mean the Securities and Exchange Commission, any successor thereto, and any analogous Governmental Authority.

Securities Account ” is any “securities account” as defined in the Code with such additions to such term as may hereafter be made.

Subordinated Debt ” is indebtedness incurred by Borrower subordinated to all of Borrower’s now or hereafter indebtedness to Bank (pursuant to a subordination, intercreditor, or other similar agreement in form and substance satisfactory to Bank entered into between Bank and the other creditor), on terms acceptable to Bank.

Subsidiary ” is, as to any Person, a corporation, partnership, limited liability company or other entity of which shares of stock or other ownership interests having ordinary voting power (other than stock or such other ownership interests having such power only by reason of the happening of a contingency) to elect a majority of the board of directors or other managers of such corporation, partnership or other entity are at the time owned, or the management of which is otherwise controlled, directly or indirectly through one or more intermediaries, or both, by such Person. Unless the context otherwise requires, each reference to a Subsidiary herein shall be a reference to a Subsidiary of Borrower or Guarantor.

Trademarks ” means any trademark and servicemark rights, whether registered or not, applications to register and registrations of the same and like protections, and the entire goodwill of the business of Borrower connected with and symbolized by such trademarks.

Tranche A ” is defined in Section 2.1.1(a) hereof.

Tranche A Growth Capital Advance ” is defined in Section 2.1.1(a).

Tranche B ” is defined in Section 2.1.1(a) hereof.

Tranche B Draw Period ” is the period of time commencing on the date that Borrower achieves the [***] Milestone through the earlier to occur of (i) June 30, 2019 or (ii) the date on which an Event of Default occurs hereunder.

Tranche B Growth Capital Advance ” is defined in Section 2.1.1(a).

Tranche C ” is defined in Section 2.1.1(a) hereof.

Tranche C Draw Period ” is the period of time commencing on the date that Borrower achieves the [***] Milestone through the earlier to occur of (i) September 30, 2019 or (ii) the date on which an Event of Default occurs hereunder.

Tranche C Growth Capital Advance ” is defined in Section 2.1.1(a).

Transfer ” is defined in Section 7.1.

Warrant ” is (i) that certain Warrant to Purchase Common Stock issued by Borrower to Bank on the Effective Date together with (ii) any other warrant(s) issued by Borrower in favor of Bank at any time theretofore or thereafter.

[ Balance of Page Intentionally Left Blank ]

 

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*** Confidential Treatment Requested.


IN WITNESS WHEREOF , the parties hereto have caused this Agreement to be executed as of the Effective Date.

BORROWER:

SIERRA ONCOLOGY, INC.

By: /s/ Nick Glover

Name: Nick Glover

Title: CEO and President

BANK:

SILICON VALLEY BANK

By: /s/ Peter Sletteland

Name: Peter Sletteland

Title: Vice President

[ Signature Page to Loan and Security Agreement ]


EXHIBIT A

COLLATERAL DESCRIPTION

The Collateral consists of all of Borrower’s right, title and interest in and to the following personal property:

All goods, Accounts (including health-care receivables), Equipment, Inventory, contract rights or rights to payment of money, leases, license agreements, franchise agreements, General Intangibles (except as provided below), commercial tort claims, documents, instruments (including any promissory notes), chattel paper (whether tangible or electronic), cash, deposit accounts, fixtures, letters of credit rights (whether or not the letter of credit is evidenced by a writing), securities, and all other investment property, supporting obligations, and financial assets, whether now owned or hereafter acquired, wherever located; and

all Borrower’s Books relating to the foregoing, and any and all claims, rights and interests in any of the above and all substitutions for, additions, attachments, accessories, accessions and improvements to and replacements, products, proceeds and insurance proceeds of any or all of the foregoing.

Notwithstanding the foregoing, the Collateral does not include (i) any Intellectual Property; provided, however, the Collateral shall include all Accounts and all proceeds of Intellectual Property or (ii) more than 65% of the issued and outstanding equity interests owned by a Borrower of any Foreign Subsidiary which shares entitle the holder thereof to vote for the election of directors or any other matter. If a judicial authority (including a U.S. Bankruptcy Court) would hold that a security interest in the underlying Intellectual Property is necessary to have a security interest in such Accounts and such property that are proceeds of Intellectual Property, then the Collateral shall automatically, and effective as of the Effective Date, include the Intellectual Property to the extent necessary to permit perfection of Bank’s security interest in such Accounts and such other property of Borrower that are proceeds of the Intellectual Property.

Pursuant to the terms of a certain negative pledge arrangement with Bank, Borrower has agreed not to encumber any of its Intellectual Property without Bank’s prior written consent.


EXHIBIT B

COMPLIANCE STATEMENT

 

TO:       SILICON VALLEY BANK

FROM: SIERRA ONCOLOGY, INC.

   Date:                               

Under the terms and conditions of the Loan and Security Agreement between Borrower and Bank (the “Agreement”), Borrower is in complete compliance for the period ending             with all required covenants except as noted below. Attached are the required documents evidencing such compliance, setting forth calculations prepared in accordance with GAAP consistently applied from one period to the next except as explained in an accompanying letter or footnotes. Capitalized terms used but not otherwise defined herein shall have the meanings given them in the Agreement.

Please indicate compliance status by circling Yes/No under “Complies” column.

 

Reporting Covenants

  

Required

  

Complies

Monthly Cash Statements with

Compliance Statement

   Monthly within 30 days            Yes    No        

10-Q, 10-K and 8-K

  

Within 5 days after filing with the

SEC, but no later than 45 days after

FQE for 10Q filings and 90 days of

FYE for 10K filings

   Yes    No

Annual Operating Budget and Financial Projections

  

Annually within the earlier of 90 days

of year end or 30 days of approval

by Borrower’s board of directors

and within 7 days of any

updates/amendments thereto

   Yes     No

Other Matters

 

Have there been any amendments of or other changes to the capitalization table of Borrower and to the Operating Documents of Borrower or any of its Subsidiaries? If yes, provide copies of any such amendments or changes with this Compliance Statement.        Yes          No  

The following are the exceptions with respect to the statements above: (If no exceptions exist, state “No exceptions to note.”)


EXHIBIT C – LOAN PAYMENT/ADVANCE REQUEST FORM

DEADLINE FOR SAME DAY PROCESSING IS NOON PACIFIC TIME

 

Fax To:    Date:                               

LOAN PAYMENT:

SIERRA ONCOLOGY, INC.

 

From Account # ________________________________

                                         (Deposit Account #)

Principal $ _____________________________________

Authorized Signature: ____________________________

Print Name/Title: ________________________________

 

To Account # ___________________________________

                                         (Loan Account #)

and/or Interest $ _________________________________

Phone Number: __________________________________

 

 

LOAN ADVANCE:

Complete Outgoing Wire Request section below if all or a portion of the funds from this loan advance are for an outgoing wire.

 

From Account # ________________________________

                                         (Deposit Account #)

To Account # ___________________________________

                                         (Loan Account #)

 

 

Amount of Growth Capital Advance $ ____________________________________

All Borrower’s representations and warranties in the Loan and Security Agreement are true, correct and complete in all material respects on the date of the request for a Growth Capital Advance; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material respects as of such date:

 

Authorized Signature: _________________________________

Phone Number: ______________________________________

 

 

Print Name/Title: _____________________________________

OUTGOING WIRE REQUEST:

Complete only if all or a portion of funds from the loan advance above is to be wired.

Deadline for same day processing is noon, Pacific Time

 

Beneficiary Name:____________________________________

Beneficiary Bank:____________________________________

City and State: _______________________________________

Beneficiary Bank Transit (ABA) #:_______________________

Intermediary Bank: ___________________________________

Amount of Wire: $ ___________________________________

Account Number: ____________________________________

Beneficiary Bank Code (Swift, Sort, Chip, etc.): ___________

                                  (For International Wire Only)

Transit (ABA) #:____________________________________

 

 

For Further Credit to: _________________________________________________________________________________________

Special Instruction: __________________________________________________________________________________________

By signing below, I (we) acknowledge and agree that my (our) funds transfer request shall be processed in accordance with and subject to the terms and conditions set forth in the agreements(s) covering funds transfer service(s), which agreements(s) were previously received and executed by me (us).

 

Authorized Signature:_________________________________

Print Name/Title:____________________________________

Telephone #:_______________________________________

2nd Signature (if required):_____________________________

Print Name/Title:____________________________________

Telephone #:_______________________________________

 

 

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EXHIBIT D

BORROWING RESOLUTIONS

 

LOGO

CORPORATE BORROWING CERTIFICATE

B ORROWER : SIERRA ONCOLOGY, INC.                                                                              D ATE : August 21, 2018

B ANK :           SILICON VALLEY BANK

I hereby certify as follows, as of the date set forth above:

1.     I am the Secretary, Assistant Secretary or other officer of Borrower. My title is as set forth below.

2.     Borrower’s exact legal name is set forth above. Borrower is a corporation existing under the laws of the State of Delaware.

3.     Attached hereto are true, correct and complete copies of Borrower’s Certificate of Incorporation (including amendments), as filed with the Secretary of State of the state in which Borrower is incorporated as set forth above. Such Certificate of Incorporation have not been amended, annulled, rescinded, revoked or supplemented, and remain in full force and effect as of the date hereof.

4.     The following resolutions were duly and validly adopted by Borrower’s Board of Directors at a duly held meeting of such directors (or pursuant to a unanimous written consent or other authorized corporate action). Such resolutions are in full force and effect as of the date hereof and have not been in any way modified, repealed, rescinded, amended or revoked, and Silicon Valley Bank (“Bank”) may rely on them until Bank receives written notice of revocation from Borrower.

R ESOLVED , that any one of the following officers or employees of Borrower, whose names, titles and signatures are below, may act on behalf of Borrower:

 

Name

  

Title

  

Signature

   Authorized
to Add or
Remove
Signatories

Nick Glover

   CEO and President    /s/ Nick Glover   

 

  

 

  

 

  
        

 

  

 

  

 

  
        

 

  

 

  

 

  
        

 

  

 

  

 

  

R ESOLVED F URTHER , that any one of the persons designated above with a checked box beside his or her name may, from time to time, add or remove any individuals to and from the above list of persons authorized to act on behalf of Borrower.

 

 

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R ESOLVED F URTHER , that such individuals may, on behalf of Borrower:

Borrow Money . Borrow money from Bank.

Execute Loan Documents . Execute any loan documents Bank requires.

Grant Security . Grant Bank a security interest in any of Borrower’s assets.

Negotiate Items . Negotiate or discount all drafts, trade acceptances, promissory notes, or other indebtedness in which Borrower has an interest and receive cash or otherwise use the proceeds.

Apply for Letters of Credit . Apply for letters of credit from Bank.

Enter Derivative Transactions . Execute spot or forward foreign exchange contracts, interest rate swap agreements, or other derivative transactions.

Issue Warrants . Issue warrants for Borrower’s capital stock.

Further Acts . Designate other individuals to request advances, pay fees and costs and execute other documents or agreements (including documents or agreement that waive Borrower’s right to a jury trial) they believe to be necessary to effect these resolutions.

R ESOLVED F URTHER , that all acts authorized by the above resolutions and any prior acts relating thereto are ratified.

5.     The persons listed above are Borrower’s officers or employees with their titles and signatures shown next to their names.

 

SIERRA ONCOLOGY, INC.
By:   /s/ Angie You
Name:   Angie You
Title:   Chief Business & Strategy Officer

 

-36-

Exhibit 10.2

SIERRA ONCOLOGY, INC.

2018 EQUITY INDUCEMENT PLAN

1. PURPOSE . The purpose of this Plan is to provide incentives to attract, retain and motivate eligible persons whose present and potential contributions are important to the success of the Company, and any Parents and Subsidiaries that exist now or in the future, by offering them an opportunity to participate in the Company’s future performance through the grant of Awards. Capitalized terms not defined elsewhere in the text are defined in Section 21.

2. SHARES SUBJECT TO THE PLAN .

2.1 Number of Shares Available . Subject to Section 2.4 and any other applicable provisions hereof, the total number of Shares reserved and available for grant and issuance pursuant to this Plan is 1,500,000.

2.2 Lapsed, Returned Awards . Shares subject to Awards, and Shares issued under the Plan under any Award, will again be available for grant and issuance in connection with subsequent Awards under this Plan to the extent such Shares: (a) are subject to issuance upon exercise of an Option granted under this Plan but which cease to be subject to the Option for any reason other than exercise of the Option; (b) are subject to Awards granted under this Plan that are forfeited or are repurchased by the Company at the original issue price or (c) are subject to Awards granted under this Plan that otherwise terminate without such Shares being issued. To the extent an Award under the Plan is paid out in cash rather than Shares, such cash payment will not result in reducing the number of Shares available for issuance under the Plan. Shares used to pay the exercise price of an Award or withheld to satisfy the tax withholding obligations related to an Award will become available for future grant or sale under the Plan.

2.3 Minimum Share Reserve . At all times the Company shall reserve and keep available a sufficient number of Shares as shall be required to satisfy the requirements of all outstanding Awards granted under this Plan.

2.4 Adjustment of Shares . If the number of outstanding Shares is changed by a stock dividend, extraordinary dividends or distributions (whether in cash, shares or other property, other than a regular cash dividend) recapitalization, stock split, reverse stock split, subdivision, combination, reclassification, spin-off or similar change in the capital structure of the Company, without consideration, then (a) the number of Shares reserved for issuance and future grant under the Plan set forth in Section 2.1, (b) the Exercise Prices of and number of Shares subject to outstanding Options and (c) the number of Shares subject to other outstanding Awards, shall be proportionately adjusted, subject to any required action by the Board or the stockholders of the Company and in compliance with applicable securities laws; provided that fractions of a Share will not be issued.


3. ELIGIBILITY . Awards may be granted only to a person who, at the time of granting of the Award by the Committee: (a) has been hired as an Employee by the Company or any Subsidiary and such Award is a material inducement to such person being hired; (b) has been rehired as an Employee following a bona fide period of interruption of employment with the Company or any Subsidiary; or (c) has become an Employee of the Company or any Subsidiary in connection with a merger or acquisition.

4. ADMINISTRATION .

4.1 Committee Composition; Authority . This Plan will be administered by the Committee or by the Board acting as the Committee. Subject to the general purposes, terms and conditions of this Plan, and to the direction of the Board, the Committee will have full power to implement and carry out this Plan. Notwithstanding the foregoing, the grant of any Award will not be effective unless: (i) if the grant is made by the Board, then it must be approved by a majority of the Outside Directors on the Board; and (ii) if the grant is made by the Committee, then the Committee must be comprised solely of Outside Directors (except as otherwise permitted under applicable rules). The Committee will have the authority to:

(a) construe and interpret this Plan, any Award Agreement and any other agreement or document executed pursuant to this Plan;

(b) prescribe, amend and rescind rules and regulations relating to this Plan or any Award;

(c) select persons to receive Awards;

(d) determine the form and terms and conditions, not inconsistent with the terms of the Plan, of any Award granted hereunder. Such terms and conditions include, but are not limited to, the exercise price, the time or times when Awards may vest and be exercised (which may be based on performance criteria) or settled, any vesting acceleration or waiver of forfeiture restrictions, the method to satisfy tax withholding obligations or any other tax liability legally due and any restriction or limitation regarding any Award or the Shares relating thereto, based in each case on such factors as the Committee will determine;

(e) determine the number of Shares or other consideration subject to Awards;

(f) determine the Fair Market Value in good faith and interpret the applicable provisions of this Plan and the definition of Fair Market Value in connection with circumstances that impact the Fair Market Value, if necessary;

(g) determine whether Awards will be granted singly, in combination with, in tandem with, or as alternatives to, other Awards under this Plan or any other incentive or compensation plan of the Company or any Parent or Subsidiary of the Company;

(h) grant waivers of Plan or Award conditions;

(i) determine the vesting, exercisability and payment of Awards;

(j) correct any defect, supply any omission or reconcile any inconsistency in this Plan, any Award or any Award Agreement;

(k) determine whether an Award has been earned;

 

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(l) reduce or waive any criteria with respect to Performance Factors;

(m) adjust Performance Factors to take into account changes in law and accounting or tax rules as the Committee deems necessary or appropriate to reflect the impact of extraordinary or unusual items, events or circumstances to avoid windfalls or hardships;

(n) adopt terms and conditions, rules and/or procedures (including the adoption of any subplan under this Plan) relating to the operation and administration of the Plan to accommodate requirements of local law and procedures outside of the United States; and

(o) make all other determinations necessary or advisable for the administration of this Plan.

4.2 Committee Interpretation and Discretion . Any determination made by the Committee with respect to any Award shall be made in its sole discretion at the time of grant of the Award or, unless in contravention of any express term of the Plan or Award, at any later time, and such determination shall be final and binding on the Company and all persons having an interest in any Award under the Plan. Any dispute regarding the interpretation of the Plan or any Award Agreement shall be submitted by the Employee or Company to the Committee for review. The resolution of such a dispute by the Committee shall be final and binding on the Company and the Employee. The Committee may delegate to one or more executive officers the authority to review and resolve disputes with respect to Awards held by Employees who are not Insiders, and such resolution shall be final and binding on the Company and the Employee.

4.3 Section 16 of the Exchange Act . Awards granted to Employees who are subject to Section 16 of the Exchange Act must be approved by two or more “non-employee directors” (as defined in the regulations promulgated under Section 16 of the Exchange Act).

4.4 Documentation . The Award Agreement for a given Award, the Plan and any other documents may be delivered to, and accepted by, an Employee or any other person in any manner (including electronic distribution or posting) that meets applicable legal requirements.

4.5 Foreign Award Recipients . Notwithstanding any provision of the Plan to the contrary, in order to comply with the laws and practices in other countries in which the Company and its Subsidiaries operate or have employees eligible for Awards, the Committee, in its sole discretion, shall have the power and authority to: (a) determine which Subsidiaries and Affiliates shall be covered by the Plan; (b) determine which Employees outside the United States are eligible to participate in the Plan; (c) modify the terms and conditions of any Award granted to individuals outside the United States or foreign nationals to comply with applicable foreign laws, policies, customs and practices; (d) establish subplans and modify exercise procedures and other terms and procedures, to the extent the Committee determines such actions to be necessary or advisable (and such subplans and/or modifications shall be attached to this Plan as appendices); provided, however, that no such subplans and/or modifications shall increase the share limitations contained in the Plan; and (e) take any action, before or after an Award is made, that the Committee determines to be necessary or advisable to obtain approval or comply with any local governmental regulatory exemptions or approvals. Notwithstanding the foregoing, the Committee may not take any actions hereunder, and no Awards shall be granted, that would violate the Exchange Act or any other applicable United States securities law, the Code, or any other applicable United States governing statute or law.

 

3


5. OPTIONS . An Option is the right but not the obligation to purchase a Share, subject to certain conditions, if applicable. The Committee may grant Options to eligible Employees and will determine the number of Shares subject to the Option, the Exercise Price of the Option, the period during which the Option may vest and be exercised, and all other terms and conditions of the Option, subject to the following terms of this section.

5.1 Option Grant . Each Option granted under this Plan will be a Nonqualified Stock Option (“ NSO ”). An Option may be, but need not be, awarded upon satisfaction of such Performance Factors during any Performance Period as are set out in advance in the Employee’s individual Award Agreement. If the Option is being earned upon the satisfaction of Performance Factors, then the Committee will: (a) determine the nature, length and starting date of any Performance Period for each Option; and (b) select from among the Performance Factors to be used to measure the performance, if any. Performance Periods may overlap and Employees may participate simultaneously with respect to Options that are subject to different performance goals and other criteria.

5.2 Date of Grant . The date of grant of an Option will be the date on which the Committee makes the determination to grant such Option, or a specified future date. The Award Agreement and a copy of this Plan will be delivered to the Employee within a reasonable time after the granting of the Option.

5.3 Exercise Period . Options may be vested and exercisable within the times or upon the conditions as set forth in the Award Agreement governing such Option; provided, however, that no Option will be exercisable after the expiration of ten (10) years from the date the Option is granted. The Committee also may provide for Options to become vested or exercisable at one time or from time to time, periodically or otherwise, in such number of Shares or percentage of Shares as the Committee determines.

5.4 Exercise Price . The Exercise Price of an Option will be determined by the Committee when the Option is granted; provided that: the Exercise Price of an Option will be not less than one hundred percent (100%) of the Fair Market Value of the Shares on the date of grant. Payment for the Shares purchased may be made in accordance with Section 7 and the Award Agreement and in accordance with any procedures established by the Company.

5.5 Method of Exercise . Any Option granted hereunder will be vested and exercisable according to the terms of the Plan and at such times and under such conditions as determined by the Committee and set forth in the Award Agreement. An Option may not be exercised for a fraction of a Share. An Option will be deemed exercised when the Company receives: (a) notice of exercise (in such form as the Committee may specify from time to time) from the person entitled to exercise the Option (and/or via electronic execution through the authorized third party administrator), and (b) full payment for the Shares with respect to which the Option is exercised (together with applicable withholding taxes). Full payment may consist of any consideration and method of payment authorized by the Committee and permitted by the Award Agreement and the Plan. Shares issued upon exercise of an Option will be issued in the name of the Employee. Until the Shares are issued (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company), no right to vote or receive dividends or any other rights as a stockholder will exist with respect to the Shares, notwithstanding the exercise of the Option. The Company will issue (or cause to be issued) such Shares promptly after the Option is exercised. No adjustment will be made for a dividend or other right for which the record date is prior to the date the Shares are issued, except as provided in Section 2.4 of the Plan. Exercising an Option in any manner will decrease the number of Shares thereafter available, both for purposes of the Plan and for sale under the Option, by the number of Shares as to which the Option is exercised.

 

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5.6 Termination of Service . If the Employee’s Service terminates for any reason except for Cause or the Employee’s death or Disability, then the Employee may exercise such Employee’s Options (only to the extent that such Options are exercisable by the Employee on the date Employee’s Service terminates) during the period ending no later than three (3) months after the date Employee’s Service terminates (or such shorter or longer time period as may be determined by the Committee), but in any event no later than the expiration date of the Options.

(a) Death . If the Employee’s Service terminates because of the Employee’s death (or the Employee dies within three (3) months after Employee’s Service terminates other than for Cause or because of the Employee’s Disability), then the Employee’s Options may be exercised only to the extent that such Options would have been exercisable by the Employee on the date Employee’s Service terminates and must be exercised by the Employee’s legal representative, or authorized assignee, no later than twelve (12) months after the date Employee’s Service terminates (or such shorter time period or longer time period as may be determined by the Committee), but in any event no later than the expiration date of the Options.

(b) Disability . If the Employee’s Service terminates because of the Employee’s Disability, then the Employee’s Options may be exercised only to the extent that such Options would have been exercisable by the Employee on the date Employee’s Service terminates and must be exercised by the Employee (or the Employee’s legal representative or authorized assignee) no later than twelve (12) months after the date Employee’s Service terminates (or such shorter or longer time period as may be determined by the Committee, but in any event no later than the expiration date of the Options.

(c) Cause . If the Employee is terminated for Cause, then Employee’s Options shall expire on such Employee’s date of termination of Service, or at such later time and on such conditions as are determined by the Committee, but in any event no later than the expiration date of the Options. Unless otherwise provided in the Award Agreement or other agreement between the Company and Employee, Cause shall have the meaning set forth in this Plan.

5.7 Limitations on Exercise . The Committee may specify a minimum number of Shares that may be purchased on any exercise of an Option, provided that such minimum number will not prevent any Employee from exercising the Option for the full number of Shares for which it is then exercisable.

5.8 Modification, Extension or Renewal . The Committee may modify, extend or renew outstanding Options and authorize the grant of new Options in substitution therefor, provided that any such action may not, without the written consent of an Employee, impair any of such Employee’s rights under any Option previously granted.

6. RESTRICTED STOCK UNITS . A Restricted Stock Unit (“ RSU ”) is an award to an eligible Employee covering a number of Shares that may be settled in cash, or by issuance of those Shares. All RSUs shall be made pursuant to an Award Agreement.

6.1 Terms of RSUs . The Committee will determine the terms of an RSU including, without limitation: (a) the number of Shares subject to the RSU; (b) the time or times during which the RSU may be settled; (c) the consideration to be distributed on settlement; and (d) the effect of the Employee’s termination of Service on each RSU. An RSU may be awarded upon satisfaction of such performance goals based on Performance Factors during any Performance Period as are set out in advance in the Employee’s Award Agreement. If the RSU is being earned upon satisfaction of Performance Factors, then the Committee will: (x) determine the nature, length and starting date of any Performance Period for the RSU; (y) select from among the Performance Factors to be used to measure the performance, if any; and (z) determine the number of Shares deemed subject to the RSU. Performance Periods may overlap and participants may participate simultaneously with respect to RSUs that are subject to different Performance Periods and different performance goals and other criteria.

 

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6.2 Form and Timing of Settlement . Payment of earned RSUs shall be made as soon as practicable after the date(s) determined by the Committee and set forth in the Award Agreement. The Committee, in its sole discretion, may settle earned RSUs in cash, Shares, or a combination of both. The Committee may also permit a Employee to defer payment under an RSU to a date or dates after the RSU is earned provided that the terms of the RSU and any deferral satisfy the requirements of Section 409A of the Code.

6.3 Termination of Service . Except as may be set forth in the Employee’s Award Agreement, vesting ceases on such date Employee’s Service terminates (unless determined otherwise by the Committee).

7. PAYMENT FOR SHARE PURCHASES . Payment from an Employee for Shares purchased pursuant to this Plan may be made in cash or by check or, where expressly approved for the Employee by the Committee and where permitted by law (and to the extent not otherwise set forth in the applicable Award Agreement):

(a) by cancellation of indebtedness of the Company to the Employee;

(b) by surrender of shares of the Company held by the Employee that have a Fair Market Value on the date of surrender equal to the aggregate exercise price of the Shares as to which said Award will be exercised or settled;

(c) by waiver of compensation due or accrued to the Employee for services rendered or to be rendered to the Company or a Parent or Subsidiary of the Company;

(d) by consideration received by the Company pursuant to a broker-assisted or other form of cashless exercise program implemented by the Company in connection with the Plan;

(e) by any combination of the foregoing; or

(f) by any other method of payment as is permitted by applicable law.

8. WITHHOLDING TAXES .

8.1 Withholding Generally . Whenever Shares are to be issued in satisfaction of Awards granted under this Plan or the applicable tax event occurs, the Company may require the Employee to remit to the Company, or to the Parent or Subsidiary employing the Employee, an amount sufficient to satisfy applicable U.S. federal, state, local and international withholding tax requirements or any other tax or social insurance liability legally due from the Employee prior to the delivery of Shares pursuant to exercise or settlement of any Award. Whenever payments in satisfaction of Awards granted under this Plan are to be made in cash, such payment will be net of an amount sufficient to satisfy applicable U.S. federal, state, local and international withholding tax or social insurance requirements or any other tax liability legally due from the Employee. The Fair Market Value of the Shares will be determined as of the date that the taxes are required to be withheld and such Shares will be valued based on the value of the actual trade or, if there is none, the Fair Market Value of the Shares as of the previous trading day.

 

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8.2 Stock Withholding . The Committee, in its sole discretion and pursuant to such procedures as it may specify from time to time and to limitations of local law, may require or permit an Employee to satisfy such tax withholding obligation or any other tax liability legally due from the Employee, in whole or in part by (without limitation) (a) paying cash, (b) electing to have the Company withhold otherwise deliverable cash or Shares having a Fair Market Value equal to up to the maximum statutory amount permitted to be withheld, (c) delivering to the Company already-owned Shares having a Fair Market Value equal to up to the maximum statutory amount permitted to be withheld or (d) withholding from the proceeds of the sale of otherwise deliverable Shares acquired pursuant to an Award either through a voluntary sale or through a mandatory sale arranged by the Company.

9. TRANSFERABILITY . Unless determined otherwise by the Committee, an Award may not be sold, pledged, assigned, hypothecated, transferred, or disposed of in any manner other than by will or by the laws of descent or distribution. If the Committee makes an Award transferable, including, without limitation, by instrument to an inter vivos or testamentary trust in which the Awards are to be passed to beneficiaries upon the death of the trustor (settlor) or by gift or by domestic relations order to a Permitted Transferee, such Award will contain such additional terms and conditions as the Committee deems appropriate. All Awards shall be exercisable: (a) during the Employee’s lifetime only by (i) the Employee, or (ii) the Employee’s guardian or legal representative; (b) after the Employee’s death, by the legal representative of the Employee’s heirs or legatees; and (c) by a Permitted Transferee

10. PRIVILEGES OF STOCK OWNERSHIP; RESTRICTIONS ON SHARES .

10.1 Voting and Dividends . No Employee will have any of the rights of a stockholder with respect to any Shares until the Shares are issued to the Employee, except for any Dividend Equivalent Rights permitted by an applicable Award Agreement. Any Dividend Equivalent Rights shall be subject to the same vesting or performance conditions as the underlying Award. In addition, the Committee may provide that any Dividend Equivalent Rights permitted by an applicable Award Agreement shall be deemed to have been reinvested in additional Shares or otherwise reinvested. After Shares are issued to the Employee, the Employee will be a stockholder and have all the rights of a stockholder with respect to such Shares, including the right to vote and receive all dividends or other distributions made or paid with respect to such Shares; provided, that if such Shares are Unvested Shares, then any new, additional or different securities the Employee may become entitled to receive with respect to such Shares by virtue of a stock dividend, stock split or any other change in the corporate or capital structure of the Company will be subject to the same restrictions as the Unvested Shares; provided, further, that the Employee will have no right to retain such stock dividends or stock distributions with respect to Shares that are repurchased at the Employee’s Exercise Price, pursuant to Section 10.2.

10.2 Restrictions on Shares . At the discretion of the Committee, the Company may reserve to itself and/or its assignee(s) a right to repurchase (a “ Right of Repurchase ”) a portion of any or all Unvested Shares held by an Employee following such Employee’s termination of Service at any time within ninety (90) days (or such longer or shorter time determined by the Committee) after the later of the date Employee’s Service terminates and the date the Employee purchases Shares under this Plan, for cash and/or cancellation of purchase money indebtedness, at the Employee’s Exercise Price.

11. CERTIFICATES . All Shares or other securities (whether or not certificated) delivered under this Plan will be subject to such stock transfer orders, legends and other restrictions as the Committee may deem necessary or advisable, including restrictions under any applicable U.S. federal, state or foreign securities law, or any rules, regulations and other requirements of the SEC or any stock exchange or automated quotation system upon which the Shares may be listed or quoted and any non-U.S. exchange controls or securities law restrictions to which the Shares are subject.

 

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12. ESCROW; PLEDGE OF SHARES . To enforce any restrictions on an Employee’s Shares, the Committee may require the Employee to deposit all certificates representing Shares, together with stock powers or other instruments of transfer approved by the Committee, appropriately endorsed in blank, with the Company or an agent designated by the Company to hold in escrow until such restrictions have lapsed or terminated, and the Committee may cause a legend or legends referencing such restrictions to be placed on the certificates. Any Employee who is permitted to execute a promissory note as partial or full consideration for the purchase of Shares under this Plan will be required to pledge and deposit with the Company all or part of the Shares so purchased as collateral to secure the payment of the Employee’s obligation to the Company under the promissory note; provided, however, that the Committee may require or accept other or additional forms of collateral to secure the payment of such obligation and, in any event, the Company will have full recourse against the Employee under the promissory note notwithstanding any pledge of the Employee’s Shares or other collateral. In connection with any pledge of the Shares, the Employee will be required to execute and deliver a written pledge agreement in such form as the Committee will from time to time approve. The Shares purchased with the promissory note may be released from the pledge on a pro rata basis as the promissory note is paid.

13. SECURITIES LAW AND OTHER REGULATORY COMPLIANCE . An Award will not be effective unless such Award is in compliance with all applicable U.S. and foreign federal and state securities and exchange control laws, rules and regulations of any governmental body, and the requirements of any stock exchange or automated quotation system upon which the Shares may then be listed or quoted, as they are in effect on the date of grant of the Award and also on the date of exercise or other issuance. Notwithstanding any other provision in this Plan, the Company will have no obligation to issue or deliver certificates for Shares under this Plan prior to: (a) obtaining any approvals from governmental agencies that the Company determines are necessary or advisable; and/or (b) completion of any registration or other qualification of such Shares under any state or federal or foreign law or ruling of any governmental body that the Company determines to be necessary or advisable. The Company will be under no obligation to register the Shares with the SEC or to effect compliance with the registration, qualification or listing requirements of any foreign or state securities laws, exchange control laws, stock exchange or automated quotation system, and the Company will have no liability for any inability or failure to do so.

14. NO OBLIGATION TO EMPLOY . The Employee’s participation in the Plan is voluntary. Nothing in this Plan or any Award granted under this Plan will confer or be deemed to confer on any Employee any right to continue in the employ of, or to continue any other relationship with, the Company or any Parent, Subsidiary or Affiliate or limit in any way the right of the Company or any Parent, Subsidiary or Affiliate to terminate Employee’s employment or other relationship at any time.

15. CORPORATE TRANSACTIONS . In the event of a Corporate Transaction any or all outstanding Awards may be assumed or replaced by the successor corporation, which assumption or replacement shall be binding on all Employees. In the alternative, the successor corporation may substitute equivalent Awards or provide substantially similar consideration to Employees as was provided to stockholders (after taking into account the existing provisions of the Awards). The successor corporation may also issue, in place of outstanding Shares of the Company held by the Employee, substantially similar shares, cash or other property subject to repurchase restrictions no less favorable to the Employee. In the event such successor or acquiring corporation (if any) refuses to assume, convert, replace or substitute Awards, as provided above, pursuant to a Corporate Transaction, then notwithstanding any other provision in this Plan to the contrary, such Awards shall have their vesting accelerate as to all shares subject to such Award (and any applicable rights of repurchase shall fully lapse) immediately prior to the Corporate Transaction. In addition, in the event such successor or acquiring corporation (if any) refuses to assume, convert, replace

 

8


or substitute Awards, as provided above, pursuant to a Corporate Transaction, the Committee will (i) notify the Employee in writing or electronically that such Award will, if applicable, be exercisable for a period of time determined by the Committee in its sole discretion, and such Award will terminate upon the earlier of the expiration of such period or immediately prior to the Corporate Transaction or (ii) provide that each Award shall be cancelled immediately upon the occurrence of the Corporate Transaction in exchange for a payment in cash or securities in an amount equal to (A) the excess of the consideration paid per Share in the Corporate Transaction over the exercise price or purchase price (if any) per Share subject to the Award multiplied by (B) the number of Shares subject to the Award. Awards need not be treated similarly in a Corporate Transaction

16. TERM OF PLAN/GOVERNING LAW . Unless earlier terminated as provided herein, this Plan will become effective on the Effective Date and will terminate on the later of ten (10) years from the date this Plan is adopted by the Committee or the date additional Shares are added to the Plan by the Committee. This Plan and all Awards granted hereunder shall be governed by and construed in accordance with the laws of the State of Delaware (excluding its conflict of law rules).

17. AMENDMENT OR TERMINATION OF PLAN . The Board or Committee may at any time terminate or amend this Plan in any respect, including, without limitation, amendment of any form of Award Agreement or instrument to be executed pursuant to this Plan; provided, however, that the Board or Committee will not, without the approval of the stockholders of the Company, amend this Plan in any manner that requires such stockholder approval; provided further, that an Employee’s Award shall be governed by the version of this Plan then in effect at the time such Award was granted.

18. NONEXCLUSIVITY OF THE PLAN . Neither the adoption of this Plan by the Committee nor any provision of this Plan will be construed as creating any limitations on the power of the Board or the Committee to adopt such additional compensation arrangements as it may deem desirable, including, without limitation, the granting of stock awards and bonuses otherwise than under this Plan, and such arrangements may be either generally applicable or applicable only in specific cases.

19. INSIDER TRADING POLICY . Each Employee who receives an Award shall comply with any policy adopted by the Company from time to time covering transactions in the Company’s securities by Employees, officers and/or directors of the Company.

20. ALL AWARDS SUBJECT TO COMPANY CLAWBACK OR RECOUPMENT POLICY . All Awards, subject to applicable law, shall be subject to clawback or recoupment pursuant to any compensation clawback or recoupment policy adopted by the Board or required by law during the term of Employee’s employment or other service with the Company that is applicable to executive officers, employees, directors or other service providers of the Company, and in addition to any other remedies available under such policy and applicable law, may require the cancellation of outstanding Awards and the recoupment of any gains realized with respect to Awards.

21. DEFINITIONS . As used in this Plan, and except as elsewhere defined herein, the following terms will have the following meanings:

21.1 Affiliate ” means (i) any entity that, directly or indirectly, is controlled by, controls or is under common control with, the Company and (ii) any entity in which the Company has a significant equity interest, in either case as determined by the Committee, whether now or hereafter existing.

21.2 Award ” means any award under this Plan, including any Option or Restricted Stock Unit.

 

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21.3 Award Agreement ” means, with respect to each Award, the written or electronic agreement between the Company and the Employee setting forth the terms and conditions of the Award, and country-specific appendix thereto for grants to non-U.S. Employees, which shall be in substantially a form (which need not be the same for each Employee) that the Committee (or in the case of Award agreements that are not used for Insiders, the Committee’s delegate(s)) has from time to time approved, and will comply with and be subject to the terms and conditions of this Plan.

21.4 Board ” means the Board of Directors of the Company.

21.5 Cause ” means (a) Employee’s conviction (including a guilty plea or plea of nolo contendere ) of any felony or any other crime involving fraud, dishonesty or moral turpitude; (b) Employee’s commission or attempted commission of or participation in a fraud or act of dishonesty or misrepresentation against the Company that results (or could reasonably be expected to result) in material harm or injury to the business or reputation of the Company; (c) Employee’s material violation of any contract or agreement between Employee and the Company, or of any Company policy, or of any statutory duty Employee owes to the Company; or (d) Employee’s conduct that constitutes gross insubordination, incompetence or habitual neglect of duties and that results in (or could reasonably be expected to have resulted in) material harm to the business or reputation of the Company. The determination as to whether an Employee is being terminated for Cause shall be made in good faith by the Company and shall be final and binding on the Employee. The foregoing definition does not in any way limit the Company’s ability to terminate an Employee’s employment or consulting relationship at any time as provided in Section 14 above, and the term “Company” will be interpreted to include any Subsidiary or Parent, as appropriate. Notwithstanding the foregoing, the foregoing definition of “Cause” may, in part or in whole, be modified or replaced in each individual employment agreement or Award Agreement with any Employee, provided that such document supersedes the definition provided in this Section 21.5.

21.6 Code ” means the United States Internal Revenue Code of 1986, as amended, and the regulations promulgated thereunder.

21.7 Committee ” means the Compensation Committee of the Board.

21.8 Common Stock ” means the common stock of the Company.

21.9 Company ” means Sierra Oncology, Inc., or any successor corporation.

21.10 Corporate Transaction ” means the occurrence of any of the following events: (a) any “Person” (as such term is used in Sections 13(d) and 14(d) of the Exchange Act) becomes the “beneficial owner” (as defined in Rule 13d-3 of the Exchange Act), directly or indirectly, of securities of the Company representing more than fifty percent (50%) of the total voting power represented by the Company’s then-outstanding voting securities; provided, however, that for purposes of this subclause (a) the acquisition of additional securities by any one Person who is considered to own more than fifty percent (50%) of the total voting power of the securities of the Company will not be considered a Corporate Transaction; (b) the consummation of the sale or disposition by the Company of all or substantially all of the Company’s assets; (c) the consummation of a merger or consolidation of the Company with any other corporation, other than a merger or consolidation which would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or its parent) at least fifty percent (50%) of the total voting power represented by the voting securities of the Company or such surviving entity or its parent outstanding immediately after such merger or consolidation; (d) any other transaction which qualifies as a “corporate transaction” under Section 424(a) of the Code wherein the stockholders of the Company give up all of their equity interest in the Company (except for the acquisition, sale or transfer of all or substantially all of the

 

10


outstanding shares of the Company) or (e) a change in the effective control of the Company that occurs on the date that a majority of members of the Board are replaced during any twelve (12) month period by members of the Board whose appointment or election is not endorsed by as majority of the members of the Board prior to the date of such appointment or election. For purpose of this subclause (e), if any Person is considered to be in effective control of the Company, the acquisition of additional control of the Company by the same Person will not be considered a Corporate Transaction. For purposes of this definition, Persons will be considered to be acting as a group if they are owners of a corporation that enters into a merger, consolidation, purchase or acquisition of stock, or similar business transaction with the Company. Notwithstanding the foregoing, to the extent that any amount constituting deferred compensation (as defined in Section 409A of the Code) would become payable under this Plan by reason of a Corporate Transaction, such amount shall become payable only if the event constituting a Corporate Transaction would also qualify as a change in ownership or effective control of the Company or a change in the ownership of a substantial portion of the assets of the Company, each as defined within the meaning of Code Section 409A, as it has been and may be amended from time to time, and any proposed or final Treasury Regulations and IRS guidance that has been promulgated or may be promulgated thereunder from time to time.

21.11 Director ” means a member of the Board.

21.12 Disability ” means in the case of incentive stock options, total and permanent disability as defined in Section 22(e)(3) of the Code and in the case of other Awards, that the Employee is unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of not less than 12 months.

21.13 Dividend Equivalent Right” means the right of an Employee, granted at the discretion of the Committee or as otherwise provided by the Plan or an Award Agreement, to receive a credit for the account of such Employee in an amount equal to the cash, stock or other property dividends in amounts equal equivalent to cash, stock or other property dividends for each Share represented by an Award held by such Employee.

21.14 Effective Date ” means September 20, 2018.

21.15 Employee ” means any person, including Officers, providing services as an employee to the Company or any Parent, Subsidiary or Affiliate. Neither service as a director nor payment of a director’s fee by the Company will be sufficient to constitute “employment” by the Company.

21.16 Exchange Act ” means the United States Securities Exchange Act of 1934, as amended.

21.17 Exercise Price ” means, with respect to an Option, the price at which a holder may purchase the Shares issuable upon exercise of an Option.

21.18 Fair Market Value ” means, as of any date, the value of a share of the Company’s Common Stock determined as follows:

(a) if such Common Stock is publicly traded and is then listed on a national securities exchange, its closing price on the date of determination on the principal national securities exchange on which the Common Stock is listed or admitted to trading as reported in The Wall Street Journal or such other source as the Board or the Committee deems reliable;

 

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(b) if such Common Stock is publicly traded but is neither listed nor admitted to trading on a national securities exchange, the average of the closing bid and asked prices on the date of determination as reported in The Wall Street Journal or such other source as the Board or the Committee deems reliable; or

(c) if none of the foregoing is applicable, by the Board or the Committee in good faith.

21.19 Insider ” means an officer or director of the Company or any other person whose transactions in the Company’s Common Stock are subject to Section 16 of the Exchange Act.

21.20 IRS ” means the United States Internal Revenue Service.

21.21 Option ” means an award of an option to purchase Shares pursuant to Section 5.

21.22 Outside Director ” means a Director who is not an Employee of the Company or any Parent or Subsidiary and who is an “independent” director under the rules of The Nasdaq Stock Market, as may be amended from time to time.

21.23 Parent ” means any corporation (other than the Company) in an unbroken chain of corporations ending with the Company if each of such corporations other than the Company owns stock possessing fifty percent (50%) or more of the total combined voting power of all classes of stock in one of the other corporations in such chain.

21.24 “Performance Factors” means the factors selected by the Committee to determine whether performance goals established by the Committee applicable to Awards have been satisfied.

21.25 Performance Period ” means the period of service determined by the Committee during which years of service or performance is to be measured for the Award.

21.26 Permitted Transferee ” means any child, stepchild, grandchild, parent, stepparent, grandparent, spouse, former spouse, sibling, niece, nephew, mother-in-law, father-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law (including adoptive relationships) of the Employee, any person sharing the Employee’s household (other than a tenant or employee), a trust in which these persons (or the Employee) have more than 50% of the beneficial interest, a foundation in which these persons (or the Employee) control the management of assets, and any other entity in which these persons (or the Employee) own more than 50% of the voting interests.

21.27 Plan ” means this Sierra Oncology, Inc. 2018 Equity Inducement Plan.

21.28 Restricted Stock Unit ” means an Award granted pursuant to Section 6 of the Plan.

21.29 SEC ” means the United States Securities and Exchange Commission.

21.30 Securities Act ” means the United States Securities Act of 1933, as amended.

21.31 Service ” shall mean service as an Employee to the Company or a Parent, Subsidiary or Affiliate, subject to such further limitations as may be set forth in the Plan or the applicable Award Agreement. An Employee will not be deemed to have ceased to provide Service in the case of (a) sick leave, (b) military leave, or (c) any other leave of absence approved by the Company; provided, that such leave is for a period of not more than 90 days (x) unless reemployment upon the expiration of such leave is guaranteed by contract or statute, or (y) unless provided otherwise pursuant to formal policy adopted from

 

12


time to time by the Company and issued and promulgated to employees in writing. In the case of any Employee on an approved leave of absence or a reduction in hours worked (for illustrative purposes only, a change in schedule from that of full-time to part-time), the Committee may make such provisions regarding suspension of or modification of vesting of the Award while on leave from the employ of the Company or a Parent, Subsidiary or Affiliate or during such change in working hours as it may deem appropriate, except that in no event may an Award be exercised after the expiration of the term set forth in the applicable Award Agreement. In the event of military leave, if required by applicable laws, vesting shall continue for the longest period that vesting continues under any other statutory or Company approved leave of absence and, upon a Employee’s returning from military leave (under conditions that would entitle him or her to protection upon such return under the Uniform Services Employment and Reemployment Rights Act), he or she shall be given vesting credit with respect to Awards to the same extent as would have applied had the Employee continued to provide services to the Company throughout the leave on the same terms as he or she was providing services immediately prior to such leave. Except as set forth in this Section 28.39, an employee shall have terminated employment as of the date he or she ceases provide services (regardless of whether the termination is in breach of local employment laws or is later found to be invalid) and employment shall not be extended by any notice period or garden leave mandated by local law, provided however , that a change in status from an employee to a consultant or advisor shall not terminate the service provider’s Service, unless determined by the Committee, in its discretion. The Committee will have sole discretion to determine whether a Employee has ceased to provide Services and the effective date on which the Employee ceased to provide Services.

21.32 Shares ” means shares of Common Stock and the common stock of any successor entity.

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

21.34 Treasury Regulations ” means regulations promulgated by the United States Treasury Department.

21.35 Unvested Shares ” means Shares that have not yet vested or are subject to a right of repurchase in favor of the Company (or any successor thereto).

 

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SIERRA ONCOLOGY, INC.

(the “Company” )

2018 EQUITY INDUCEMENT PLAN

(the “ Plan ”)

ADDENDUM FOR CANADIAN PARTICIPANTS

 

A.

The Company has adopted the Plan, to be effective on the Effective Date.

 

B.

The Company desires to modify certain terms of the Plan in their application for Employees (as those terms are defined in the Plan) who are resident in Canada for purposes of the Income Tax Act (Canada) or otherwise subject to Canadian personal income tax (the “ Canadian Employees ”).

 

C.

Under the Income Tax Act (Canada), Employees who are Canadian Employees are treated as officers and employees for purposes of that Act.

NOW THEREFORE , the Company does hereby amend certain terms and conditions of the Plan as they apply to the Canadian Employees, as follows.

 

1.

Defined Terms . In this Addendum, all defined terms shall have the respective meanings set forth in the Plan, unless otherwise defined herein.

 

2.

Effective Date . The effective date of this Addendum is the Effective Date.

 

3.

Options .

 

  (a)

Notwithstanding section 5.2 of the Plan, the grant date of an Option awarded to a Canadian Employee shall be, in all cases, the date the Option is actually granted to the Canadian Employee, as evidenced by the Award Agreement.

 

  (b)

Notwithstanding section 5.1 of the Plan, satisfaction of Performance Factors, if any, will be treated as a condition subsequent to the grant to a Canadian Employee of an Option giving rise to a risk of forfeiture of the Option and not a condition precedent to the grant of the Option.

 

  (c)

For purposes of section 5.9 of the Plan, Options granted to a Canadian Employee will not be modified or altered, or new options granted in substitution therefor, if such modification, alteration or substitution has a material adverse affect on such Canadian Employee’s tax treatment of such Options, except with such Canadian Employee’s consent.

 

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4.

Restricted Stock Units .

Section 6.2 of the Plan shall be modified as it applies to Canadian Employees such that the Company agrees to issue only Shares in payment of RSUs to a Canadian Employee and the Company cannot choose, at its option, to make such payment in cash or a combination of cash and Shares, and section 6.2 shall read as follows:

“6.2. Form and Timing of Settlement to Canadian Employees. Payment of earned RSUs of a Canadian Employee shall be made as soon as practicable after the date(s) determined by the Committee and set forth in the Award Agreement. Such earned RSUs shall be settled solely by the issuance of Shares. The Committee may permit a Canadian Employee to defer settlement and the issuance of Shares in payment of an earned RSU to a date that is acceptable to the Committee, provided that the terms of the Award Agreement, the RSUs and any deferral meet the conditions of section 7 of the Income Tax Act (Canada).”

 

5.

Payment for Share Purchases .

Section 7(b) of the Plan shall be modified as at applies to Canadian Employees with respect to the consideration that may be paid by Canadian Employees for Shares purchased pursuant to the Plan. In no circumstances shall a Canadian Employee be permitted to make, and the Committee shall not approve, a payment by the Canadian Employee by the surrender of any Shares that were acquired at any time by the Canadian Employee on the exercise of any Option.

 

6.

Withholding Taxes .

 

  (a)

Section 8.1 of the Plan shall be modified as it applies to Canadian Employees and shall read as follows:

“8.1 Withholding for Canadian Employees. The Company or any Affiliate may take such reasonable steps for the deduction and withholding of any taxes and other required source deductions which the Company or Affiliate, as the case may be, is required by law or regulation of any governmental authority whatsoever to remit in connection with the exercise or settlement of any Award granted to a Canadian Employee. Without limiting the generality of the foregoing, whenever a settlement or payment is made by the issuance of Shares to a Canadian Employee in satisfaction of Awards granted under this Plan, the Company or Affiliate, as the case may be, may, at its discretion (i) deduct and withhold those amounts it is required to remit from any cash remuneration or other amount payable to the Canadian Employee, whether or not such amount payable is related to the Plan, or the exercise or settlement of any Awards; (ii) permit the Canadian Employee to make a cash payment to the Company or Affiliate, as the case may be, equal to the amount required to be remitted; or (iii) sell, on behalf of the Canadian Employee, that number of Shares to be issued on the exercise or settlement such that the amount of the proceeds of such sale will be sufficient to satisfy any taxes or other source deductions required to be remitted for the account of the Canadian Employee. If the Company or Affiliate, as the case may be, considers that the foregoing steps undertaken in connection with this section 13.1 result in inadequate withholding or a late remittance of taxes or other source deductions, then the delivery of Shares to be issued on the exercise or settlement of Awards may be made conditional upon the Canadian Employee (or other person) reimbursing or compensating the Company or Affiliate or making arrangements satisfactory to the Company or Affiliate for the payment in a timely manner of all taxes and other source deductions required to be remitted.”

 

  (b)

Section 8.2 of the Plan shall not apply to Canadian Employees. For greater certainty, the Committee shall not approve funding by a Canadian Employee of withholding taxes or other source deductions by the withholding of Shares the Canadian Employee is otherwise entitled to receive or the surrender by the Canadian Employee of any Shares that were acquired at any time by the Canadian Employee on the exercise of any Option.

 

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N OTICE OF S TOCK O PTION G RANT

SIERRA ONCOLOGY, INC. 2018 EQUITY INDUCEMENT

PLAN

Unless otherwise defined herein, the terms defined in the Sierra Oncology, Inc. (the “ Company ”) 2018 Equity Inducement Plan (the “ Plan ”) shall have the same meanings in this Notice of Stock Option Grant (the “ Notice of Grant ”) and the attached Stock Option Agreement (the “ Option Agreement ”). You have been granted an Option to purchase shares of Common Stock of the Company under the Plan subject to the terms and conditions of the Plan, this Notice of Grant and the attached Option Agreement.

Name:                                                                                                                                                                                                                                                

Address:                                                                                                                                                                                                                                           

 

Date of Grant:                                                                           
Vesting Commencement Date:                                                                           
Exercise Price per Share:                                                                           
Total Number of Shares:                                                                           
Type of Option:   Non-Qualified Stock Option   
Expiration Date:                        , 20      ; This Option expires earlier if your Service terminates earlier, as described in the Stock Option Agreement.
Vesting Schedule:     
Additional Terms:   If this box is checked, the additional terms and conditions set forth on Attachment 1 hereto (as executed by the Company) are applicable and are incorporated herein by reference. No document need be attached as Attachment 1 if the box is not checked.

You understand that your employment relationship with the Company is for an unspecified duration, can be terminated at any time (i.e., is “at-will”), and that nothing in this Notice, the Option Agreement or the Plan changes the at-will nature of that relationship. By accepting this Option, you and the Company agree that this Option is granted under and governed by the terms and conditions of the Plan, the Notice of Grant and the Option Agreement. By accepting this Option, you consent to electronic delivery as set forth in the Option Agreement.

 

PARTICIPANT:     SIERRA ONCOLOGY, INC.

 

    By:
Signature:                                                                                               Name:                                                                                               
Print Name:                                                                                            Its:                                                                                                     


STOCK OPTION AGREEMENT

SIERRA ONCOLOGY, INC.

2018 EQUITY INDUCEMENT PLAN

You have been granted an Option by Sierra Oncology, Inc. (the “ Company ”) under the 2018 Equity Inducement Plan (the “ Plan ”) to purchase Shares (the “ Option ”), subject to the terms, restrictions and conditions of the Plan, the Notice of Stock Option Grant (the “ Notice of Grant ”) and this Stock Option Agreement (the “ Agreement ”).

1. Grant of Option . You have been granted an Option for the number of Shares set forth in the Notice of Grant at the exercise price per Share set forth in the Notice of Grant (the “ Exercise Price ”). In the event of a conflict between the terms and conditions of the Plan and the terms and conditions of this Agreement, the terms and conditions of the Plan shall prevail. The Option is designated as a Nonqualified Stock Option (“ NSO ”).

2. Termination Period .

(a) General Rule. If your Service terminates for any reason except death or Disability, and other than for Cause, then this Option will expire at the close of business at Company headquarters on the date three (3) months after your termination of Service (subject to the expiration detailed in Section 6). If your Service is terminated for Cause, this Option will expire upon the date of such termination. The Company determines when your Service terminates for all purposes under this Agreement. You acknowledge and agree that the Vesting Schedule may change prospectively in the event that your service status changes between full and part-time status in accordance with Company policies relating to work schedules and vesting of awards. You acknowledge that the vesting of the Shares pursuant to this Notice is earned only by continuing Service and that any unvested portion of your Option will expire on the termination of your employment for any reason.

(b) Death; Disability. If you die before your Service terminates (or you die within three (3) months of your termination of Service other than for Cause), then this Option will expire at the close of business at Company headquarters on the date twelve (12) months after the date of your death (subject to the expiration detailed in Section 6). If your Service terminates because of your Disability, then this Option will expire at the close of business at Company headquarters on the date twelve (12) months after your termination date (subject to the expiration detailed in Section 6).

(c) Black-Out Period. Notwithstanding the foregoing, if any post-termination exercise period set forth above terminates on a date that falls within a Blackout Period (as defined below) or within ten (10) business days following the expiration of a Blackout Period, such expiration date shall be automatically extended without any further act or formality to that date which is ten (10) business days after the end of such Blackout Period, with such tenth (10th) business day to be considered the expiration date of such Option for all purposes under the Plan, subject to earlier expiration detailed in Section 6. For purposes of this Agreement, “ Blackout Period ” means the period during which designated directors, officers and employees of the Company cannot trade Shares pursuant to the Company’s policy respecting restrictions on director’, officers’ and employee trading which is in effect at the time.


(d) No Notice . You are responsible for keeping track of these exercise periods following your termination of Service for any reason. The Company will not provide further notice of such periods. In no event shall this Option be exercised later than the Expiration Date set forth in the Notice of Grant.

3. Exercise of Option .

(a) Right to Exercise . This Option is exercisable during its term in accordance with the Vesting Schedule set forth in the Notice of Grant and the applicable provisions of the Plan and this Agreement. In the event of your death, Disability, or other cessation of Service, the exercisability of the Option is governed by the applicable provisions of the Plan, the Notice of Grant and this Agreement. This Option may not be exercised for a fraction of a Share.

(b) Method of Exercise . This Option is exercisable by delivery of an exercise notice in a form specified by the Company (the “ Exercise Notice ”), which shall state the election to exercise the Option, the number of Shares in respect of which the Option is being exercised (the “ Exercised Shares ”), and such other representations and agreements as may be required by the Company pursuant to the provisions of the Plan. The Exercise Notice shall be delivered in person, by mail, via electronic mail or facsimile or by other authorized method to the Secretary of the Company or other person designated by the Company. The Exercise Notice shall be accompanied by payment of the aggregate Exercise Price as to all Exercised Shares. This Option shall be deemed to be exercised upon receipt by the Company of a fully executed Exercise Notice accompanied by the aggregate Exercise Price and any applicable tax withholding due upon exercise of the Option.

(c) Exercise by Another . If another person wants to exercise this Option after it has been transferred to him or her in compliance with this Agreement and the Plan, that person must prove to the Company’s satisfaction that he or she is entitled to exercise this Option. That person must also complete the proper Exercise Notice form (as described above) and pay the Exercise Price (as described below) and any applicable tax withholding due upon exercise of the Option (as described below).

4. Method of Payment . Payment of the aggregate Exercise Price shall be by personal check, wire transfer, cashier’s check, or, with the Company’s consent; any of the following, or a combination thereof:

(a) certificates for shares of Company stock that you own, along with any forms needed to effect a transfer of those shares to the Company; the Fair Market Value of the shares, determined as of the effective date of the Option exercise, will be applied to the Option Exercise Price. Instead of surrendering shares of Company stock, you may attest to the ownership of those shares on a form provided by the Company and have the same number of shares subtracted from the Option shares issued to you. However, you may not surrender, or attest to the ownership of, shares of Company stock in payment of the Exercise Price of your Option if your action would cause the Company to recognize compensation expense (or additional compensation expense) with respect to this Option for financial reporting purposes;

(b) cashless exercise through irrevocable directions to a securities broker approved by the Company to sell all or part of the Shares covered by this Option and to deliver to the Company from the sale proceeds an amount sufficient to pay the Option Exercise Price and any withholding taxes. The balance of the sale proceeds, if any, will be delivered to you. The directions must be given by signing a special notice of exercise form provided by the Company; or

(c) other method authorized by the Company.

 

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5. Non-Transferability of Option . In general, except as provided below, only you may exercise this Option prior to your death. You may not transfer or assign this Option, except as provided below. For instance, you may not sell this Option or use it as security for a loan. If you attempt to do any of these things, this Option will immediately become invalid. You may, however, dispose of this Option in your will or in a beneficiary designation. However, the Committee (as defined in the Plan) may, in its sole discretion, allow you to transfer this Option as a gift to one or more family members. For purposes of this Agreement, “family member” means a child, stepchild, grandchild, parent, stepparent, grandparent, spouse, former spouse, sibling, niece, nephew, mother-in-law, father-in-law, son-in-law, daughter-in-law, brother-in-law or sister-in-law (including adoptive relationships), any individual sharing your household (other than a tenant or employee), a trust in which one or more of these individuals have more than 50% of the beneficial interest, a foundation in which you or one or more of these persons control the management of assets, and any entity in which you or one or more of these persons own more than 50% of the voting interest. In addition, the Committee may, in its sole discretion, allow you to transfer this Option to your spouse or former spouse pursuant to a domestic relations order in settlement of marital property rights. The Committee will allow you to transfer this Option only if both you and the transferee(s) execute the forms prescribed by the Committee, which include the consent of the transferee(s) to be bound by this Agreement. This Option may not be transferred in any manner other than by will or by the laws of descent or distribution or court order and may be exercised during the lifetime of you only by you, your guardian, or legal representative, as permitted in the Plan. The terms of the Plan and this Agreement shall be binding upon the executors, administrators, heirs, successors and assigns of you.

6. Term of Option . This Option shall in any event expire on the expiration date set forth in the Notice of Grant, which date is ten (10) years after the grant date.

7. Tax Consequences . You should consult a tax adviser for tax consequences relating to this Option in the jurisdiction in which you are subject to tax. YOU SHOULD CONSULT A TAX ADVISER BEFORE EXERCISING THIS OPTION OR DISPOSING OF THE SHARES. You will not be allowed to exercise this Option unless you make arrangements acceptable to the Company to pay any withholding taxes that may be due as a result of the Option exercise.

8. Withholding Taxes and Stock Withholding . Regardless of any action the Company or your actual employer (the “ Employer ”) takes with respect to any or all income tax, social insurance, payroll tax, payment on account or other tax-related withholding (“ Tax-Related Items ”), you acknowledge that the ultimate liability for all Tax-Related Items legally due by you is and remains your responsibility and that the Company and/or the Employer (1) make no representations or undertakings regarding the treatment of any Tax-Related Items in connection with any aspect of the Option grant, including the grant, vesting or exercise of the Option, the subsequent sale of Shares acquired pursuant to such exercise and the receipt of any dividends; and (2) do not commit to structure the terms of the grant or any aspect of the Option to reduce or eliminate your liability for Tax-Related Items. You acknowledge that if you are subject to Tax-Related Items in more than one jurisdiction, the Company and/or the Employer may be required to withhold or account for Tax-Related Items in more than one jurisdiction.

Prior to exercise of the Option, you shall pay or make adequate arrangements satisfactory to the Company and/or the Employer to satisfy all withholding and payment on account obligations of the Company and/or the Employer. In this regard, you authorize the Company and/or the Employer to withhold all applicable Tax-Related Items legally payable by you from your wages or other cash compensation paid to you by the Company and/or the Employer. With the Company’s consent, these arrangements may also include, if permissible under local law, (a) withholding Shares that otherwise would be issued to you when you exercise this Option, by considering applicable statutory or other withholding rates, including up to maximum rates, (b) having the Company withhold taxes from the proceeds of the sale of the Shares, either through a voluntary sale or through a mandatory sale arranged by the Company (on your behalf and you

 

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hereby authorize such sales by this authorization), (c) your payment of a cash amount, or (d) any other arrangement approved by the Company; all under such rules as may be established by the Committee and in compliance with the any insider trading or 10b-51 trading policies of the Company, if applicable; provided however, that if you are a Section 16 officer of the Company under the Exchange Act, then the Committee (as constituted in accordance with Rule 16b-3 under the Exchange Act) shall establish the method of withholding from alternatives (a)-(d) above, and the Committee shall establish the method prior to the Tax-Related Items withholding event. The Fair Market Value of these Shares, determined as of the effective date of the Option exercise, will be applied as a credit against the withholding taxes. You shall pay to the Company or the Employer any amount of Tax-Related Items that the Company or the Employer may be required to withhold as a result of your participation in the Plan or your purchase of Shares that cannot be satisfied by the means previously described. Finally, you acknowledge that the Company has no obligation to deliver Shares to you until you have satisfied the obligations in connection with the Tax-Related Items as described in this Section.

9. Acknowledgement . The Company and you agree that the Option is granted under and governed by the Notice of Grant, this Agreement and the provisions of the Plan (incorporated herein by reference). You: (i) acknowledge receipt of a copy of the Plan prospectus, (ii) represent that you have carefully read and are familiar with their provisions, and (iii) hereby accept the Option subject to all of the terms and conditions set forth herein and those set forth in the Plan and the Notice of Grant. You hereby agree to accept as binding, conclusive and final all decisions or interpretations of the Committee upon any questions relating to the Plan, the Notice of Grant and the Agreement.

10. Consent to Electronic Delivery of All Plan Documents and Disclosures . By your acceptance of this Option, you consent to the electronic delivery of the Notice of Grant, this Agreement, account statements, Plan prospectuses required by the Securities and Exchange Commission, U.S. financial reports of the Company, and all other documents that the Company is required to deliver to its security holders (including, without limitation, annual reports and proxy statements) or other communications or information related to the Option. Electronic delivery may include the delivery of a link to a Company intranet or the internet site of a third party involved in administering the Plan, the delivery of the document via e-mail or such other delivery determined at the Company’s discretion. You acknowledge that you may receive from the Company a paper copy of any documents delivered electronically at no cost if you contact the Company by telephone, through a postal service or electronic mail at _____________. You further acknowledge that you will be provided with a paper copy of any documents delivered electronically if electronic delivery fails; similarly, you understand that you must provide on request to the Company or any designated third party a paper copy of any documents delivered electronically if electronic delivery fails. Also, you understand that your consent may be revoked or changed, including any change in the electronic mail address to which documents are delivered (if you have provided an electronic mail address), at any time by notifying the Company of such revised or revoked consent by telephone, postal service or electronic mail at ______________. Finally, you understand that you are not required to consent to electronic delivery.

11. Compliance with Laws and Regulations . The exercise of this Option will be subject to and conditioned upon compliance by the Company and you with all applicable state, federal and foreign laws and regulations and with all applicable requirements of any stock exchange or automated quotation system on which the Company’s Common Stock may be listed or quoted at the time of such issuance or transfer. The Shares issued pursuant to this Agreement shall be endorsed with appropriate legends, if any, determined by the Company.

 

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12. Governing Law; Severability . If one or more provisions of this Agreement are held to be unenforceable under applicable law, the parties agree to renegotiate such provision in good faith. In the event that the parties cannot reach a mutually agreeable and enforceable replacement for such provision, then (i) such provision shall be excluded from this Agreement, (ii) the balance of this Agreement shall be interpreted as if such provision were so excluded and (iii) the balance of this Agreement shall be enforceable in accordance with its terms. This Agreement and all acts and transactions pursuant hereto and the rights and obligations of the parties hereto shall be governed, construed and interpreted in accordance with the laws of the State of Delaware, without giving effect to principles of conflicts of law. For purposes of litigating any dispute that may arise directly or indirectly from the Plan, the Notice and this Agreement, the parties hereby submit and consent to litigation in the exclusive jurisdiction of the State of Delaware.

13. No Rights as Employee . Nothing in this Agreement shall affect in any manner whatsoever the right or power of the Company, or a Parent, Subsidiary or Affiliate of the Company, to terminate your Service, for any reason, with or without Cause.

14. Adjustment . In the event of a stock split, a stock dividend or a similar change in Company stock, the number of Shares covered by this Option and the Exercise Price per Share may be adjusted pursuant to the Plan.

15. Award Subject to Company Clawback or Recoupment . To the extent permitted by applicable law, the Option shall be subject to clawback or recoupment pursuant to any compensation clawback or recoupment policy adopted by the Board or required by law during the term of your employment or other Service that is applicable to you. In addition to any other remedies available under such policy, applicable law may require the cancellation of your Option (whether vested or unvested) and the recoupment of any gains realized with respect to your Option.

16. Entire Agreement; Enforcement of Rights . This Agreement, the Plan and the Notice constitute the entire agreement and understanding of the parties relating to the subject matter herein and supersede all prior discussions between them. Any prior agreements, commitments or negotiations concerning this Option are superseded. No modification of or amendment to this Agreement, nor any waiver of any rights under this Agreement, shall be effective unless in writing and signed by the parties to this Agreement. The failure by either party to enforce any rights under this Agreement shall not be construed as a waiver of any rights of such party.

BY ACCEPTING THIS OPTION, YOU AGREE TO ALL OF THE TERMS AND CONDITIONS DESCRIBED ABOVE AND IN THE PLAN.

 

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EXHIBIT 31.1

CERTIFICATION OF PERIODIC REPORT UNDER SECTION 302 OF

THE SARBANES-OXLEY ACT OF 2002

I, Nick Glover, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Sierra Oncology, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 8, 2018

 

/s/ Nick Glover

Dr. Nick Glover
Chief Executive Officer
(Principal Executive Officer )

EXHIBIT 31.2

CERTIFICATION OF PERIODIC REPORT UNDER SECTION 302 OF

THE SARBANES-OXLEY ACT OF 2002

I, Sukhi Jagpal, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Sierra Oncology, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 8, 2018

 

/s/ Sukhi Jagpal

Sukhi Jagpal
Chief Financial Officer
(Principal Financial Officer)

EXHIBIT 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350

AS ADOPTED PURSUANT TO SECTION 906

OF THE SARBANES-OXLEY ACT OF 2002

I, Nick Glover, Chief Executive Officer of Sierra Oncology, Inc. (Company), do hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

 

   

the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2018 (Report), as filed with the Securities and Exchange Commission, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

   

the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the periods presented therein.

Date: November 8, 2018

 

/s/ Nick Glover

Dr. Nick Glover
Chief Executive Officer
(Principal Executive Officer )

EXHIBIT 32.2

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350

AS ADOPTED PURSUANT TO SECTION 906

OF THE SARBANES-OXLEY ACT OF 2002

I, Sukhi Jagpal, Chief Financial Officer of Sierra Oncology, Inc. (Company), do hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

 

   

the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2018 (Report), as filed with the Securities and Exchange Commission, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

   

the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the periods presented therein.

Date: November 8, 2018

 

/s/ Sukhi Jagpal

Sukhi Jagpal
Chief Financial Officer
(Principal Financial Officer)