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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

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

For the quarterly period ended June 30, 2015

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: 001-36781

 

 

Juno Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   46-3656275

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

307 Westlake Avenue North, Suite 300

Seattle, WA

  98109
(Address of principal executive offices)   (Zip Code)

(206) 582-1600

(Registrant’s telephone number, including area code)

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

 

Title of each class

 

Name of each exchange on which registered

Common stock, par value $0.0001 per share   The NASDAQ Global Select Market

Securities registered pursuant to Section 12(g) of the Act: None

 

 

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

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes   x     No   ¨

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

 

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

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

The number of shares outstanding of the registrant’s common stock as of August 7, 2015 was 100,556,371.

 

 

 


Table of Contents

Juno Therapeutics, Inc.

Quarterly Report on Form 10-Q

TABLE OF CONTENTS

 

         Page  
  PART I   

Item 1.

 

Financial Statements

     3   

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     34   

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

     42   

Item 4.

 

Controls and Procedures

     43   
  PART II   

Item 1.

 

Legal Proceedings

     44   

Item 1A.

 

Risk Factors

     44   

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

     91   

Item 3.

 

Defaults Upon Senior Securities

     92   

Item 4.

 

Mine Safety Disclosures

     92   

Item 5.

 

Other Information

     92   

Item 6.

 

Exhibits

     92   
 

Signatures

     93   

 

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Juno Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

 

     June 30, 2015     December 31, 2014  
     (unaudited)        

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 39,518      $ 355,968   

Marketable securities

     264,055        79,672   

Prepaid expenses and other current assets

     4,182        3,595   
  

 

 

   

 

 

 

Total current assets

     307,755        439,235   

Property and equipment, net

     28,689        4,018   

Long-term marketable securities

     9,839        38,411   

Goodwill

     122,092        —     

Intangible assets

     50,758        —     

Other assets

     5,036        7,499   
  

 

 

   

 

 

 

Total assets

   $ 524,169      $ 489,163   
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 1,902      $ 1,096   

Accrued liabilities and other current liabilities

     26,341        14,577   

Success payment liabilities

     127,791        84,920   

Contingent consideration obligations

     4,422        —     
  

 

 

   

 

 

 

Total current liabilities

     160,456        100,593   

Build-to-suit lease obligation, less current portion

     9,483        —     

Contingent consideration obligations, less current portion

     32,686        —     

Deferred tax liabilities

     10,240        —     

Other long-term liabilities

     —          38   

Commitments and Contingencies (Note 11)

    

Stockholders’ equity:

    

Preferred stock, $0.0001 par value; 5,000,000 shares authorized at June 30, 2015 and December 31, 2014; 0 shares issued and outstanding at June 30, 2015 and December 31, 2014

     —          —     

Common stock, $0.0001 par value, 495,000,000 shares authorized at June 30, 2015 and December 31, 2014; 84,625,858 and 82,073,647 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively

     9        8   

Additional paid-in-capital

     789,348        734,895   

Accumulated other comprehensive loss

     (849     (90

Accumulated deficit

     (477,204     (346,281
  

 

 

   

 

 

 

Total stockholders’ equity

     311,304        388,532   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 524,169      $ 489,163   
  

 

 

   

 

 

 

See accompanying notes.

 

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Juno Therapeutics, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(unaudited)

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2015     2014     2015     2014  

Revenue

   $ 12,461      $ —        $ 12,461      $ —     

Operating expenses:

        

Research and development

     60,235        6,479        118,034        9,418   

General and administrative

     14,857        4,568        21,527        7,959   

Litigation

     5,334        1,633        6,025        3,623   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     80,426        12,680        145,586        21,000   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (67,965     (12,680     (133,125     (21,000

Interest income, net

     158        —          353        —     

Other income (expenses), net

     233        (10,089     233        (10,718
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (67,574     (22,769     (132,539     (31,718

Benefit from income taxes

     1,616        —          1,616        —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (65,958   $ (22,769   $ (130,923   $ (31,718
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders:

        

Net loss

   $ (65,958   $ (22,769   $ (130,923   $ (31,718

Deemed dividend upon issuance of convertible preferred stock, non-cash

     —          (15,357     —          (15,357
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders

   $ (65,958   $ (38,126   $ (130,923   $ (47,075
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share attributable to common stockholders, basic and diluted

   $ (0.79   $ (5.80   $ (1.58   $ (7.06
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average common shares outstanding, basic and diluted

     83,716,681        6,576,466        83,116,743        6,664,013   
  

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes.

 

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Juno Therapeutics, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(In thousands)

(unaudited)

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2015     2014     2015     2014  

Net loss

   $ (65,958   $ (22,769   $ (130,923   $ (31,718

Other comprehensive loss:

        

Unrealized loss on marketable securities

     (706     —          (634     —     

Foreign currency translation

     (125     —          (125     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive loss

     (831     —          (759     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $ (66,789   $ (22,769   $ (131,682   $ (31,718
  

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes.

 

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Juno Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(unaudited)

 

     Six Months Ended June 30,  
     2015     2014  

OPERATING ACTIVITIES

    

Net loss

   $ (130,923   $ (31,718

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

    

Depreciation and amortization

     2,210        9   

Stock-based compensation

     12,475        1,588   

Loss from remeasurement of fair value of convertible preferred stock options

     —          10,718   

Deferred income taxes

     (519     —     

Deferred tax benefit recorded in connection with acquisition

     (1,100     —     

Change in fair value of success payment liabilities

     42,871        386   

Change in fair value of contingent consideration obligation

     (80     —     

Gain on initial investment in Stage

     (227     —     

Changes in operating assets and liabilities:

    

Prepaid expenses and other assets

     (1,588     (1,869

Accounts payable, accrued liabilities and other liabilities

     6,723        (2,479
  

 

 

   

 

 

 

Net cash used in operating activities

     (70,158     (23,365

INVESTING ACTIVITIES

    

Purchases of marketable securities

     (222,178     —     

Sales and maturities of marketable securities

     64,115        —     

Acquisitions, net of cash acquired

     (77,666     —     

Purchase of cost-method investment

     —          (3,455

Purchase of property and equipment

     (9,154     (715
  

 

 

   

 

 

 

Net cash used in investing activities

     (244,883     (4,170

FINANCING ACTIVITIES

    

Payment of issuance costs related to issuance of common stock

     (1,683     —     

Proceeds from issuance of convertible preferred stock

     —          62,614   

Proceeds from exercise of stock options

     368        —     

Payments of build-to-suit lease obligation

     (82     —     
  

 

 

   

 

 

 

Net cash (used in)/provided by financing activities

     (1,397     62,614   

Effect of exchange rate changes on cash and cash equivalents

     (12     —     

Net (decrease)/increase in cash and cash equivalents

     (316,450     35,079   

Cash and cash equivalents at beginning of period

     355,968        35,966   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 39,518      $ 71,045   
  

 

 

   

 

 

 

SUPPLEMENTAL CASH FLOW INFORMATION

    

Purchases of property and equipment included in accounts payable and accrued liabilities

   $ 6,675      $ —     
  

 

 

   

 

 

 

Amounts capitalized under build-to-suit leases

   $ 9,910      $ —     
  

 

 

   

 

 

 

Issuance of common stock for acquisitions

   $ 41,611      $ —     
  

 

 

   

 

 

 

Fair value of convertible preferred stock option at issuance

   $ —        $ (6,889
  

 

 

   

 

 

 

Convertible preferred stock issuance costs incurred but unpaid

   $ —        $ 187   
  

 

 

   

 

 

 

See accompanying notes.

 

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Juno Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

1. Significant Accounting Policies

Organization and Basis of Presentation

Juno Therapeutics, Inc. (the “Company”) was incorporated in Delaware on August 5, 2013 as FC Therapeutics, Inc., and changed its name to Juno Therapeutics, Inc. on October 23, 2013. The Company is building a fully-integrated biopharmaceutical company focused on revolutionizing medicine by re-engaging the body’s immune system to treat cancer. Founded on the vision that the next important phase of medicine will be driven by the use of human cells as therapeutic entities, the Company is developing cell-based cancer immunotherapies based on its chimeric antigen receptor (“CAR”) and high-affinity T cell receptor (“TCR”) technologies to genetically engineer T cells to recognize and kill cancer cells.

In May 2015, the Company acquired all the remaining ownership interests in Stage Cell Therapeutics GmbH (“Stage”) not already held by it. See Note 2, Acquisitions. As a result of the acquisition, Stage has become a wholly owned subsidiary of the Company and the results of Stage have been consolidated with the Company’s results since the date of the acquisition. Stage has operations in Göttingen and Munich, Germany and its operations are focused on developing technology platforms, including novel reagents and automation technologies, that enable the development and production of cell therapeutics. Stage has been renamed as Juno Therapeutics GmbH (“Juno GmbH”).

In June 2015, the Company acquired X-Body, Inc. (“X-Body”). See Note 2, Acquisitions. As a result of the acquisition, X-Body has become a wholly owned subsidiary of the Company and the results of X-Body have been consolidated with the Company’s results since the date of the acquisition. X-Body has operations in Waltham, Massachusetts and its operations are focused on the discovery of human monoclonal antibodies and discovery of TCR binding domains.

The Company is subject to a number of risks similar to other biopharmaceutical companies in the early stage, including, but not limited to, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s products, protection of proprietary technology, and the need to obtain adequate additional funding, If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability. As of June 30, 2015, the Company had an accumulated deficit of $477.2 million.

The financial data as of December 31, 2014 is derived from audited financial statements, which are included in our Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 19, 2015 (the “2014 Annual Report”), and should be read in conjunction with the audited financial statements and notes thereto.

Use of Estimates

The preparation of the Company’s consolidated financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from such estimates.

The Company utilizes significant estimates and assumptions in determining the estimated success payment and contingent consideration liabilities and associated expense at each balance sheet date. A small change in the Company’s stock price may have a relatively large change in the estimated fair value of the success payment liability and associated expense. Changes in the probabilities and estimated timing used in the calculation of the contingent consideration liability may have a relatively large impact of the resulting liability and associated expense.

Prior to becoming a public company, the Company utilized significant estimates and assumptions in determining the fair value of its common stock for financial reporting purposes. The Company recorded expense for restricted stock

 

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grants at prices not less than the fair market value of its common stock as determined by the board of directors, taking into consideration input from management and independent third-party valuation analysis, and in accordance with the AICPA Accounting and Valuation Guide, Valuation of Privately-Held Company Equity Securities Issued as Compensation. The estimated fair value of the Company’s common stock was based on a number of objective and subjective factors, including external market conditions affecting the biotechnology industry sector and the prices at which the Company sold shares of convertible preferred stock, and the superior rights and preferences of securities senior to the Company’s common stock at the time.

Unaudited Interim Financial Information

The accompanying interim balance sheet as of June 30, 2015, the statements of operations and comprehensive loss for the three and six months ended June 30, 2015 and 2014, and statements of cash flows for the six months ended June 30, 2015 and 2014 and the related footnote disclosures are unaudited. These unaudited interim condensed consolidated financial statements have been prepared in accordance with GAAP. In management’s opinion, the unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of June 30, 2015 and its results of operations and comprehensive loss for the three and six months ended June 30, 2015 and 2014, and its cash flows for the six months ended June 30, 2015 and 2014. The results for the three and six months ended June 30, 2015 and 2014 are not necessarily indicative of the results expected for the full fiscal year or any other interim period.

Initial Public Offering

On December 23, 2014, the Company closed its initial public offering (“IPO”) and issued and sold 12,676,354 shares of common stock (inclusive of 1,653,437 shares of common stock sold by the Company pursuant to the full exercise of the underwriters’ option to purchase additional shares) at a price to the public of $24.00 per share. The shares began trading on The NASDAQ Global Select Market on December 19, 2014. The aggregate net proceeds received by the Company from the offering, net of underwriting discounts and commissions and offering expenses, were $279.7 million. Upon the closing of the IPO, all then-outstanding shares of Company convertible preferred stock converted into 59,909,397 shares of common stock. The related carrying value of $387.7 million was reclassified to common stock and additional paid-in capital. Additionally, the Company amended and restated its certificate of incorporation effective December 23, 2014 to, among other things, change the authorized number of shares of common stock to 495,000,000 shares and the authorized number of shares of preferred stock to 5,000,000 shares.

Comprehensive Loss

Comprehensive loss is comprised of net loss and other comprehensive income or loss. Other comprehensive income or loss consists of unrealized gains and losses on marketable securities and foreign currency translation adjustments.

Cash and Cash Equivalents

The Company considers all highly liquid investments with original maturities of three months or less at acquisition to be cash equivalents. Cash equivalents, which consist primarily of money market funds, are stated at fair value.

Marketable Securities

The Company generally invests its excess cash in investment grade short- to intermediate-term fixed income securities. Such investments are included in cash and cash equivalents, marketable securities, or long-term marketable securities on the balance sheets, classified as available-for-sale, and reported at fair value with unrealized gains and losses included in accumulated other comprehensive income (loss). Realized gains and losses on the sale of these securities are recognized in net income or loss. The cost of marketable securities sold is based on the specific identification method.

The Company periodically evaluates whether declines in fair values of its investments below their book value are other-than-temporary. This evaluation consists of several qualitative and quantitative factors regarding the severity and duration of the unrealized loss as well as the Company’s ability and intent to hold the investment until a forecasted recovery occurs. Additionally, the Company assesses whether it has plans to sell the security or it is more likely than not it will be required to sell any investment before recovery of its amortized cost basis. Factors

 

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considered include quoted market prices, recent financial results and operating trends, implied values from any recent transactions or offers of investee securities, credit quality of debt instrument issuers, other publicly available information that may affect the value of our investments, duration and severity of the decline in value, and our strategy and intentions for holding the investment.

Property and Equipment, Net

Property and equipment consist of laboratory equipment, computer equipment and software, leasehold improvements and build-to suit property. Property and equipment is stated at cost, and depreciated using the straight-line method over the estimated useful lives of the respective assets.

 

Laboratory equipment    5 years
Computer equipment and software    3 years
Leasehold improvements    Shorter of asset’s useful life or remaining term of lease
Build-to-suit property    10 years

Build-to-Suit Lease Accounting

In certain lease arrangements, the Company is involved in the construction of a building. To the extent the Company is involved with structural improvements of the construction project or takes construction risk prior to the commencement of a lease, the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 840-40, Leases – Sale-Leaseback Transactions (Subsection 05-5) , requires the Company to be considered the owner solely for accounting purposes, even though the Company is not the legal owner. In these instances, the Company will record an asset and build-to-suit lease obligation on its balance sheet equal to the fair value of the building.

Once construction is complete, the Company will consider the requirements for sale-leaseback accounting treatment, including evaluating whether all risks of ownership have transferred back to the landlord, as evidenced by a lack of continuing involvement in the leased property. If the arrangement does not qualify for sale-leaseback accounting treatment, the building asset remains on the Company’s balance sheet at its historical cost, and such asset is depreciated over its estimated useful life. The Company bifurcates its lease payments into a portion allocated to the building and a portion allocated to the parcel of land on which the building has been built. The portion of the lease payments allocated to the land is treated for accounting purposes as operating lease payments, and therefore is recorded as rent expense in the condensed consolidated statements of operations. The portion of the lease payments allocated to the building is further bifurcated into a portion allocated to interest expense and a portion allocated to reduce the build-to-suit lease obligation.

The interest rate used for the build-to-suit lease obligation represents our estimated incremental borrowing rate, adjusted to reduce any built in loss.

Other Assets

The Company accounted for its investment in a minority interest of Stage, which minority interest the Company acquired in 2014, over which the Company as of December 31, 2014 had not exercised significant influence, using the cost method in accordance with ASC 325-20, Cost Method Investments . Under the cost method, an investment is carried at cost until it is sold or there is evidence that changes in the business environment or other facts and circumstances suggest it may be other than temporarily impaired. This investment totaled $3.5 million as of December 31, 2014 and was included in other assets on the balance sheet. In May 2015, the Company acquired the remaining ownership interests in Stage. See Note 2, Acquisitions.

Impairment of Long-Lived Assets

The Company regularly reviews the carrying value and estimated lives of all of its long-lived assets, including property and equipment, to determine whether indicators of impairment may exist which warrant adjustments to carrying values or estimated useful lives. The determinants used for this evaluation include management’s estimate of the asset’s ability to generate positive income from operations and positive cash flow in future periods as well as the strategic significance of the assets to the Company’s business objective. Should an impairment exist, the impairment loss would be measured based on the excess of the carrying amount of the asset’s fair value. The Company has not recognized any impairment losses since inception.

 

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Goodwill and Intangible Assets

Goodwill represents the excess of the purchase price over the net amount of identifiable assets acquired and liabilities assumed in a business combination measured at fair value. The Company evaluates goodwill for impairment annually during the fourth quarter and upon the occurrence of triggering events or substantive changes in circumstances that could indicate a potential impairment by assessing qualitative factors or performing a quantitative analysis in determining whether it is more likely than not that the fair value of the net assets are below their carrying amounts.

Intangible assets acquired in a business combination are recognized separately from goodwill and are initially recognized at their fair value at the acquisition date (which is regarded as their cost). Intangible assets related to in-process research and development (“IPR&D”) are treated as indefinite-lived intangible assets and not amortized until certain regulatory approval is obtained in a major market, typically either the U.S. or the EU in the case of X-Body, and in the case of Stage, when the acquired reagents or automation technology is accepted by the FDA as part of an IND, subject to management judgment. At that time, the Company will determine the useful life of the asset, reclassify the asset out of IPR&D and begin amortization. Intangible assets are reviewed for impairment at least annually or if indicators of potential impairment exist. There were no impairments as of June 30, 2015.

Contingent Consideration from Business Combinations

At and subsequent to the acquisition date of a business combination, contingent consideration obligations are remeasured to fair value at each balance sheet date with changes in fair value recognized in research and development expense in the condensed consolidated statements of operations. Changes in fair values reflect changes to the Company’s assumptions regarding probabilities of successful achievement of related milestones, the timing in which the milestones are expected to be achieved, and the discount rate used to estimate the fair value of the obligation, as well as the foreign currency impact of the contingent consideration for the Stage acquisition as it is denominated in Euro.

Fair Value of Financial Instruments

The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs:

Level 1 – Quoted prices in active markets for identical assets or liabilities

Level 2 – Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly

Level 3 – Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability

Our financial instruments, in addition to those presented in Note 5, Fair Value Measurements, include cash and cash equivalents, accounts payable and accrued liabilities. The carrying amount of cash and cash equivalents, accounts payable and accrued liabilities approximate fair value because of the short-term nature of these instruments.

Convertible Preferred Stock

Prior to its IPO, the Company had several series of convertible preferred stock outstanding. The carrying value of the Company’s convertible preferred stock is adjusted to reflect dividends when and if declared by the board of directors. No dividends have been declared by the board of directors since inception. The Company classified its convertible preferred stock outside of permanent equity as the redemption of such stock was not solely under the control of the Company. Upon the occurrence of the IPO in December 2014, the carrying value of the convertible preferred stock was reclassified to common stock and additional paid-in capital.

 

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Convertible Preferred Stock Option

Pursuant to certain 2013 and 2014 convertible preferred stock purchase agreements, the Company had the right to sell, or “put,” additional shares of Series A and A-2 convertible preferred stock in subsequent closings as well as potential obligations to issue additional shares upon the occurrence of certain events. The Company assessed its rights and potential obligations to sell additional shares and determined them to be a single unit of accounting, with classification outside of equity in accordance with ASC 480, Distinguishing Liabilities from Equity . As of each balance sheet date, the fair value of these combined instruments was estimated using the option pricing model and assumptions that are based on the individual characteristics of the option on the valuation date, as well as assumptions for expected volatility, expected term, and risk-free interest rate.

The Company recorded these combined instruments as convertible preferred stock options as of the date of the initial closings of the Series A convertible preferred stock financing and Series A-2 convertible preferred stock financing. The options were revalued to fair value at each subsequent balance sheet date, with fair value changes recognized as increases or reductions to other income (expense), net in the condensed consolidated statements of operations. The Company estimated the fair value of these instruments based on the Black-Scholes option pricing model. These options were exercised during 2014. For the three and six months ended June 30, 2014, $10.1 million and $10.7 million was recognized in other expense, respectively, related to the changes in fair value of these options.

Success Payments

The Company granted rights to share-based success payments to the Fred Hutchinson Cancer Research Center (“FHCRC”) and the Memorial Sloan Kettering Cancer Center (“MSK”) pursuant to the terms of its collaboration agreements with each of those entities. Pursuant to the terms of these arrangements, the Company may be required to make success payments based on increases in the per share fair market value of the Company’s common stock, payable in cash or publicly-traded equity at the Company’s discretion. See Note 3, Collaboration and License Agreements. The success payments are accounted for under ASC 505-50, Equity-Based Payments to Non-Employees . Once the service period is complete, the instruments will be accounted for under ASC 815, Derivatives and Hedging , and continue to be marked to market with all changes in value recognized immediately in other income or expense.

Success payment liabilities are estimated at fair value at inception and at each subsequent balance sheet date and the expense is amortized using the accelerated attribution method over the remaining term (service period) of the related collaboration agreement or related possible payment due date (whichever is sooner). To determine the estimated fair value of the success payments the Company uses a Monte Carlo simulation methodology which models the future movement of stock prices based on several key variables. The following variables were incorporated in the estimated fair value of the success payment liability: estimated term of the success payments, fair value of common stock, expected volatility, risk-free interest rate, and estimated number and timing of valuation measurement dates on the basis of which payments may be triggered. For FHCRC success payments, estimated indirect costs related to the collaboration projects conducted by FHCRC that are creditable against the success payments are also included in the calculation. The computation of expected volatility was estimated using a combination of available information about the historical volatility of stocks of similar publicly-traded companies for a period matching the expected term assumption and our historical volatility. In addition, prior to the Company becoming publicly traded there was one valuation measurement date on the basis of which payments may be triggered. There are several valuation measurement dates subsequent to the IPO on the basis of which payments may be triggered.

As of June 30, 2015 and December 31, 2014, the estimated fair value of the total success payment obligation was approximately $211.4 million and $195.9 million, respectively. The Company recognized research and development expense of $4.0 million and $0.2 million in the three months ended June 30, 2015 and 2014, respectively, with respect to the success payment obligations. The Company recognized research and development expense of $42.9 million and $0.4 million in the six months ended June 30, 2015 and 2014, respectively, with respect to the success payment obligations. The expense recorded for the three and six months ended June 30, 2015 and 2014 represents the change in the success payment liability during such periods and reflects an additional three or six months of accrued expense, respectively. The success payment liabilities on the condensed consolidated balance sheets as of June 30, 2015 and December 31, 2014 were $127.8 million and $84.9 million, respectively.

The assumptions used to calculate the fair value of the success payments are subject to a significant amount of judgment including the expected volatility, estimated term, and estimated number and timing of valuation measurement dates. A small change in the assumptions may have a relatively large change in the estimated

 

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valuation and associated liability and expense. For example, keeping all other variables constant, a hypothetical 10% increase in the stock price at June 30, 2015 from $53.33 per share to $58.66 per share would have increased the expense recorded in the three months ended June 30, 2015 associated with the success payment liability by $15.5 million. A hypothetical 10% decrease in the stock price from $53.33 per share to $48.00 per share would have decreased the expense recorded in the three months ended June 30, 2015 associated with the success payment liability by $15.7 million, resulting in a gain of $11.7 million. Further, keeping all other variables constant, a hypothetical 35% increase in the stock price at June 30, 2015 from $53.33 per share to $72.00 per share would have increased the expense recorded in the three months ended June 30, 2015 associated with the success payment liability by $147.2 million. A hypothetical 35% decrease in the stock price from $53.33 per share to $34.66 per share would have decreased the expense recorded in the three months ended June 30, 2015 associated with the success payment liability by $56.3 million, resulting in a gain of $52.3 million. If the fair value of the Company’s common stock at the first valuation measurement date in December 2015 remains at its June 30, 2015 value of $53.33, the Company will be required to make a $75 million payment to FHCRC and a $10 million payment to MSK, payable in cash or stock at the Company’s discretion.

Concentrations of Credit Risk and Off-Balance Sheet Risk

The Company maintains its cash, cash equivalents, and marketable securities with high quality, accredited financial institutions. These amounts at times may exceed federally insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to significant risk on these funds. The Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements.

Revenue

The Company recognizes revenue in accordance with ASC 605, Revenue Recognition . Accordingly, revenue is recognized for each unit of accounting when all of the following criteria are met:

 

    persuasive evidence of an arrangement exists;

 

    delivery has occurred or services have been rendered;

 

    the seller’s price to the buyer is fixed or determinable; and

 

    collectability is reasonably assured.

Revenue is primarily related to an initial license fee received in the three and six months ended June 30, 2015. See Note 3, Collaboration and License Agreements, under the heading “St. Jude Children’s Research Hospital/Novartis” for additional information.

Research and Development Expense

The Company records expense for research and development costs to operations as incurred. The Company accounts for nonrefundable 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. Research and development expenses consist of costs incurred by the Company for the discovery and development of the Company’s product candidates and include:

 

    personnel-related expenses, including non-cash stock-based compensation expense;

 

    external research and development expenses incurred under arrangements with third parties, such as contract research organizations, contract manufacturing organizations, academic and non-profit institutions and consultants;

 

    the estimated fair value of the liability attributable to the elapsed service period as of the balance sheet date associated with the Company’s success payments to FHCRC and MSK;

 

    changes in the estimated fair value of the contingent consideration liabilities;

 

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    license fees; and

 

    other expenses, which include direct and allocated expenses for laboratory, facilities, and other costs.

General and Administrative Expense

General and administrative costs are expensed as incurred and include personnel-related expenses including non-cash stock-based compensation for our personnel in executive, legal, finance and accounting, and other administrative functions, non-litigation legal costs, as well as fees paid for accounting and tax services, consulting fees, and facilities costs not otherwise included in research and development expenses. Non-litigation legal costs include general corporate legal fees and patent costs.

Litigation Expense

Litigation expense includes legal expense the Company incurred with respect to Trustees of the University of Pennsylvania v. St. Jude Children’s Research Hospital , Civil Action No. 2:13-cv-01502-SD (E.D. Penn), as well as expenses the Company is required to reimburse to St. Jude Children’s Research Hospital (“St. Jude”) with respect to such litigation. See Note 3, Collaboration and License Agreements.

Stock-Based Compensation

Under ASC 718, Compensation—Stock Compensation, the Company measures and recognizes expense for restricted stock awards, restricted stock unit (“RSU”) awards, and stock options granted to employees and directors based on the fair value of the awards on the date of grant. The fair value of stock options is estimated at the date of grant using the Black-Scholes option pricing model that requires management to apply judgment and make estimates, including:

 

    the expected term of the option, which is calculated using the simplified method, as permitted by the Securities and Exchange Commission (“SEC”) Staff Accounting Bulletin No. 110, Share-Based Payment , as the Company has insufficient historical information regarding its stock options to provide a basis for an estimate;

 

    the expected volatility of the underlying common stock, which the Company estimates based on the historical volatility of a representative group of publicly traded biopharmaceutical companies with similar characteristics;

 

    the risk-free interest rate, which is based on the yield curve of U.S. Treasury securities with periods commensurate with the expected term of the options being valued;

 

    the expected dividend yield, which the Company estimates to be zero based on the fact that the Company has never paid cash dividends and has no present intention to pay cash dividends; and

 

    the fair value of the Company’s common stock on the date of grant.

Stock-based compensation expense for restricted stock, RSUs, and stock options is recognized over the requisite service period, which is generally the vesting period of the respective award. The Company is required to estimate a forfeiture rate to calculate the stock-based compensation expense for its awards. The Company’s forfeiture rate is based on an analysis of its actual forfeitures since the adoption of its equity award plan. Since inception, the Company’s estimated forfeiture rate has been de minimis . The Company routinely evaluates the appropriateness of the forfeiture rate based on actual forfeiture experience, analysis of employee turnover and expectations of future option exercise behavior.

The Company also granted restricted stock awards that vest in conjunction with certain performance conditions to certain key employees, scientific founders, and directors. At each reporting date, the Company is required to evaluate whether achievement of the performance conditions is probable. Compensation expense is recorded over the appropriate service period based upon the Company’s assessment of accomplishing each performance provision. Compensation expense is measured using the fair value of the award at the grant date, net of forfeitures, and is adjusted annually to reflect actual forfeitures.

The Company also grants stock-based awards to certain service providers who are not employees, scientific founders, or directors. Stock-based awards issued to such persons, or to directors for non-board related services, are

 

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accounted for based on the fair value of such services received or of the equity instruments issued, whichever is more reliably measured. The fair value of such awards is subject to remeasurement at each reporting period until services required under the arrangement are completed, which is the vesting date.

Patent Costs

The costs related to acquiring patents and to prosecuting and maintaining intellectual property rights are expensed as incurred to general and administrative due to the uncertainty surrounding the drug development process and the uncertainty of future benefits.

Income Taxes

The Company determines its deferred tax assets and liabilities based on the differences between the financial reporting and tax bases of assets and liabilities. The deferred tax assets and liabilities are measured using the enacted tax rates that will be in effect when the differences are expected to reverse. A valuation allowance is recorded when it is more likely than not that the deferred tax asset will not be recovered. The Company applies judgment in the determination of the consolidated financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company recognizes any material interest and penalties related to unrecognized tax benefits in income tax expense.

The Company is required to file income tax returns in the U.S. federal jurisdiction and various state and foreign jurisdictions. The Company currently is not under examination by the Internal Revenue Service or other jurisdictions for any tax years.

Foreign Currency Translation

Assets and liabilities denominated in foreign currencies were translated into U.S. dollars, the reporting currency, at the exchange rate prevailing at the balance sheet date. Revenue and expenses denominated in foreign currencies were translated into U.S. dollars at the monthly average exchange rate for the period and the translation adjustments are reported as an element of accumulated other comprehensive income or loss on the condensed consolidated balance sheets.

Net Loss per Share Attributable to Common Stockholders

Basic and diluted net loss per share attributable to common stockholders is calculated by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period, without consideration for common stock equivalents. The Company’s potentially dilutive shares, which include unvested restricted stock, unvested RSUs, options to purchase common stock, and potential shares issued for success payments, 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. The following table reconciles net loss to net loss attributable to common stockholders (in thousands, except share and per share data):

 

    Three Months Ended June 30,     Six Months Ended June 30,  
    2015     2014     2015     2014  

Net loss

  $ (65,958   $ (22,769   $ (130,923   $ (31,718

Deemed dividend upon issuance of convertible preferred stock

    —          (15,357     —          (15,357
 

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders

  $ (65,958   $ (38,126   $ (130,923   $ (47,075
 

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average number of common shares used in net loss per share attributable to common stockholders – basic and diluted

    83,716,681        6,576,466        83,116,743        6,664,013   
 

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share attributable to common stockholders – basic and diluted

  $ (0.79   $ (5.80   $ (1.58   $ (7.06
 

 

 

   

 

 

   

 

 

   

 

 

 

 

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The amounts in the table below were excluded from the calculation of diluted net loss per share attributable to common stockholders for the periods indicated due to their anti-dilutive effect:

 

     As of June 30,  
     2015      2014  

Series A convertible preferred stock

     —           16,930,668   

Series A-1 convertible preferred stock

     —           2,250,000   

Series A-2 convertible preferred stock

     —           15,656,049   

Unvested restricted common stock and restricted stock units

     6,837,535         9,478,601   

Options to purchase common stock

     4,453,101         —     

Estimated shares issued if success payment valuation occurred at June 30, 2015 (1)

     1,593,850         —     
  

 

 

    

 

 

 

Total

     12,884,486         44,315,318   
  

 

 

    

 

 

 

 

(1) Represents the number of shares that would be issued if the success payment valuation date had been June 30, 2015. The Company’s common stock price per share was $53.33 at June 30, 2015 which would have resulted in a success payment of $85 million ($75 million for FHCRC and $10 million for MSK). The number of shares issued is calculated by dividing the $85 million success payment by the stock price per share of $53.33 at June 30, 2015. At June 30, 2014 the stock price was below the threshold that would require a payment to FHCRC or MSK, therefore no shares are included.

Recent Accounting Pronouncements

In 2014, the FASB issued new accounting guidance related to revenue recognition. This new standard will replace all current GAAP guidance on this topic and establishes principles for recognizing revenue upon the transfer of promised goods or services to customers, in an amount that reflects the expected consideration received in exchange for those goods or services. This guidance can be applied either retrospectively to each period presented or as a cumulative-effect adjustment as of the date of adoption. In July 2015, the FASB voted to defer the effective date to January 1, 2018 with early adoption permitted beginning January 1, 2017. The Company is evaluating the impact of adopting the new accounting guidance on its financial statements.

2. Acquisitions

Acquisition of Stage

On May 11, 2015, the Company completed the acquisition of all the outstanding ownership interests in Stage not already held by it. Prior to the acquisition, the Company held a 4.76% equity interest in Stage. As a result of the acquisition, Stage became a wholly owned subsidiary of the Company. The Company paid €52.5 million, or $58.5 million, in cash and issued an aggregate of 486,279 shares of common stock, valued at $22.2 million based on the closing stock price on May 11, 2015 of $45.58 per share, to the selling shareholders.

The Company also agreed to pay additional amounts of up to an aggregate of €135.0 million in cash based on the achievement of certain technical, clinical, regulatory, and commercial milestones related to novel reagents (€40.0 million), advanced automation technology (€65.0 million), and Stage’s existing clinical pipeline (€30.0 million). The fair value of this contingent consideration was estimated to be $28.2 million at the date of acquisition. Payments could vary based on milestones that are reached.

The elements of the purchase consideration are as follows (in thousands):

 

Cash paid (1)

   $ 58,496   

Common stock issued (2)

     22,165   

Fair value of contingent consideration (3)

     28,244   
  

 

 

 

Total consideration for 95.24% equity

     108,905   
  

 

 

 

Fair value of 4.76% initial investment in Stage (4)

     3,682   
  

 

 

 

Implied purchase price consideration for 100% equity

   $ 112,587   
  

 

 

 

 

(1) The cash consideration represents the consideration paid in cash amounting to €52.5 million which is translated based on an exchange rate of 1.1142 EUR/USD on May 11, 2015.
(2) Based on the share purchase agreement, the purchase consideration included 486,279 shares of the Company’s common stock. The closing stock price on the transaction date was $45.58 per share.
(3)

The fair value of the contingent consideration was determined by calculating the probability-weighted

 

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  milestone payments based on the assessment of the likelihood and estimated timing that certain milestones would be achieved. The fair value of the contingent consideration is estimated using a discount rate of 14.6%. The discount rate captures the credit risk associated with the payment of the contingent consideration when earned and due.
(4) The fair value of the initial investment is calculated as the implied per share fair value of the stock based upon the acquisition purchase price reduced by a lack of control discount associated with the 4.76% holding. Upon acquiring the remaining outstanding ownership interests in Stage, the Company re-measured its original equity interest to its fair value and recognized a $0.2 million gain during the six months ended June 30, 2015, which was recorded in other income (expense) on the condensed consolidated statements of operations.

The Company accounted for the Stage acquisition using the acquisition method. The acquisition method of accounting requires, among other things, that the assets acquired and liabilities assumed in a business combination be measured at their fair values as of the closing date of the acquisition. The allocation of the purchase price is based on estimates of the fair value of assets acquired and liabilities assumed as of the date of acquisition. The components of the purchase price allocation are as follows (in thousands):

 

Net working capital

   $ 1,863   

Property and equipment

     651   
  

 

 

 

Net assets acquired

     2,514   
  

 

 

 

Deferred tax liabilities

     (10,801

Acquired in-process research and development

     34,457   

Goodwill

     86,417   
  

 

 

 

Total consideration transferred

   $ 112,587   
  

 

 

 

The fair value of the acquired in-process research and development has been estimated using the replacement cost method. Under this method, the Company estimated the cost of recreating the technology and derived an estimated value to develop the technology. In-process research and development are required to be classified as indefinite-lived assets until the successful completion or the abandonment of the associated research and development effort. Accordingly, during the development period after the date of acquisition, these assets will not be amortized until the acquired reagents or automation technology is accepted by the FDA as part of an IND, subject to management judgement. At that time, the Company will determine the useful life of the asset and begin amortization. If the associated research and development effort is abandoned, the related in-process research and development assets will be written-off and an impairment charge recorded.

The excess of the purchase price over the estimated fair value of the tangible net assets and identifiable intangible assets acquired was recorded as goodwill. The factors contributing to the recognition of the amount of goodwill are based on several strategic and synergistic benefits that are expected to be realized from the Stage acquisition. The acquisition of Stage is intended to provide the Company access to transformative cell selection and activation capabilities, next generation manufacturing automation technologies, enhanced control of its supply chain, and lower expected long-term cost of goods. None of the goodwill is expected to be deductible for income tax purposes.

Acquisition of X-Body

On June 1, 2015, the Company completed the acquisition of 100% of the outstanding equity in X-Body. The Company paid $21.3 million in cash and issued an aggregate of 366,434 shares of common stock, valued at $19.4 million based on the closing stock price on June 1, 2015 of $53.07 per share, to the former X-Body stockholders. Further, an additional 72,831 shares of common stock were issued to two former X-Body stockholders in the transaction, which shares are subject to monthly vesting over the three years following the closing of the transaction, contingent on such former X-Body stockholders providing consulting services to the Company through each such vesting date. These will be accounted for as post-acquisition compensation expenses.

The Company also agreed to pay additional amounts in cash upon the realization of specified milestones substantially as follows, with respect to products generated using the X-Body technology: $5.0 million per target upon the achievement, during a specified period, of a certain regulatory milestone for products that utilize a certain type of binding mechanism; up to $30.0 million upon the achievement, during a specified period, of regulatory and clinical milestones for the first product using another type of binding mechanism (any product using such type of binding mechanism, a “Type X Product”); $5.0 million per product upon the achievement, during a specified period,

 

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of a certain regulatory milestone for a certain number of subsequent Type X Products; $50.0 million upon the achievement, during a specified period, of a clinical milestone related to the first product with certain specified binding properties (a “Type Y Product”); and $20.0 million upon the achievement, during a specified period, of a clinical milestone related to the first product with certain other specified binding properties. If a Type X Product or a Type Y Product is commercialized, Juno can choose either to make a commercialization milestone payment for such a product or to pay a low single-digit royalty on net sales of such a product. The fair value of this contingent consideration was estimated to be $8.9 million at the date of acquisition. Payments could vary based on milestones that are reached.

 

Cash paid

   $ 21,331   

Common stock issued (1)

     19,447   

Fair value of contingent consideration (2)

     8,944   

Settlement of preexisting obligation (3)

     1,123   
  

 

 

 

Total consideration

   $ 50,845   
  

 

 

 

 

(1) Based on the share purchase agreement, the purchase consideration included 366,434 shares of the Company’s common stock. The closing stock price on the transaction date was $53.07 per share.
(2) The fair value of the contingent consideration was determined by calculating the probability-weighted milestone based on the assessment of the likelihood and estimated timing that certain milestones would be achieved. The fair value of the contingent consideration is estimated using a discount rate of 15.2%. The discount rate captures the credit risk associated with the payment of the contingent consideration when earned and due.
(3) The settlement of preexisting obligation reflects the effective settlement of the Company’s preexisting prepaid contract research agreement with X-Body. No gain or loss was recognized by the Company on the effective settlement of this prepaid expense as of the acquisition date.

The allocation of the purchase price is based on estimates of the fair value of assets acquired and liabilities assumed as of the acquisition date. The components of the purchase price allocation are as follows (in thousands):

 

Net liabilities assumed

   $ (181

Deferred tax liabilities

     (1,099

Acquired in-process research and development

     16,450   

Goodwill

     35,675   
  

 

 

 

Total consideration transferred

   $ 50,845   
  

 

 

 

The fair value of the acquired in-process research and development has been estimated using the replacement cost method. Under this method, the Company estimated the cost to recreate the technology and derived an estimated value to develop the technology. In-process research and development are required to be classified as indefinite-lived assets until the successful completion or the abandonment of the associated research and development effort. Accordingly, during the development period after the date of acquisition, these assets will not be amortized until regulatory approval is obtained in a major market, typically either the United States or the EU, subject to management judgment. At that time, the Company will determine the useful life of the asset and begin amortization. If the associated research and development effort is abandoned, the related in-process research and development assets will be written-off and an impairment charge recorded.

The excess of the purchase price over the estimated fair value of the tangible net assets and identifiable intangible assets acquired was recorded as goodwill. The goodwill recognized as a result of the X-Body acquisition is primarily attributable to the fact that the acquisition furthers the Company’s strategy of investing in technologies that augment the company’s capabilities to create best-in-class engineered T cells against a broad array of cancer targets. The acquisition brings in-house to the Company an innovative discovery platform that interrogates the human antibody repertoire, rapidly selecting fully human antibodies with desired characteristics, even against difficult targets. None of the goodwill is expected to be deductible for income tax purposes.

 

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Post-Acquisition and Pro Forma Consolidated Financial Information

The Stage and X-Body acquisitions did not have a material impact on the Company’s condensed consolidated statements of operations, and therefore actual and pro forma disclosures have not been presented. The intangible assets acquired in the Stage and X-Body acquisitions are in-process research and development assets, and as such, there would be no pro forma adjustment needed for the amortization of intangible assets.

Transaction Costs

The Company incurred approximately $4.2 million of direct transaction costs related to the Stage and X-Body acquisitions for the three and six months ended June 30, 2015. These costs are included in general and administrative expenses in the condensed consolidated statements of operations.

3. Collaboration and License Agreements

Celgene

In June 2015, the Company entered into a Master Research and Collaboration Agreement (the “Collaboration Agreement”) with Celgene Corporation and Celgene RIVOT Ltd. (collectively, “Celgene”) pursuant to which the Company and Celgene agreed to collaborate on researching, developing, and commercializing novel cellular therapy product candidates and other immuno-oncology and immunology therapeutics, including, in particular, CAR and TCR product candidates. Pursuant to the collaboration, prior to the exercise of an option for a program, each of the Company and Celgene will conduct independent programs to research, develop, and commercialize such product candidates (including, in the case of the Company, its CD19 and CD22 programs). Each party has certain options to obtain either an exclusive license to develop and commercialize specified product candidates arising from specified types of programs conducted by the other party within the scope of the collaboration, or the right to participate in the co-development and co-commercialization of specified product candidates arising from such programs, in each case in specified territories. Further, following the exercise of an option, Celgene has the right to exercise an option for a specified number of such programs, excluding the CD19 program and the CD22 program, to co-develop and co-commercialize products arising out of such programs in certain countries, and each of Celgene and Company has the right to elect to participate in certain commercialization activities for products in such programs in territories where it is not leading commercialization of such product. The parties may exercise their options with respect to specified product candidates arising under programs within the scope of the collaboration until the tenth anniversary of the effective date of the Collaboration Agreement (the “Research Collaboration Term”), subject to a tail period applicable to certain programs, for which options have not yet been exercised as of the expiration of the Research Collaboration Term.

For Company-originated programs (which may include the CD19 program and the CD22 program) under the collaboration for which Celgene exercises its option to obtain an exclusive license:

 

    The Company would be responsible for research and development in the United States, Canada, and Mexico, and, for cellular therapy product candidates, China, and would retain commercialization rights and would lead commercialization activities and book sales of products in those countries (the “Juno Territory”), subject to Celgene’s option, for a specified number of programs, to elect to co-develop and co-commercialize product candidates arising from such programs, or for other programs, to elect to participate in certain commercialization activities in the Juno Territory, as further described below. Under all such license agreements, the Company has the right to participate in specified commercialization activities arising from such programs in certain major European markets;

 

    On a program-by-program basis, Celgene would receive an exclusive license, and pursuant to such license would be responsible for, development and commercialization outside of the Juno Territory (the “Celgene Territory”), including by leading commercialization activities and booking sales of products in the Celgene Territory. Celgene would be required to pay the Company a royalty on sales of products arising from such program in the Celgene Territory as further described below; and
    For Company-originated programs, excluding CD19 and CD22, Celgene would have the right to exercise an option for a specified number of such programs, to obtain the right to co-develop and co-commercialize products arising from such program worldwide, except for China. For each such program, following Celgene’s exercise of such option, the parties would enter into an agreed form of co-development and co-commercialization agreement, pursuant to which:

 

    Celgene would have the right to co-develop and co-commercialize product candidates arising from such programs, with the parties each entitled to bear and receive an equal share of the profits and losses arising from development and commercialization activities in such programs worldwide (other than China);

 

    The Company would remain the lead party for development and commercialization activities for such product candidates in the Juno Territory, and Celgene would remain the lead party for development and commercialization activities for such product candidates in the Celgene Territory, subject to the Company’s right to participate in certain commercialization activities in certain major European countries, and Celgene’s right to elect to participate in a specified percentage of commercialization activities in the Juno Territory;

 

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For other Company originated programs for which Celgene does not exercise such a co-development and co-commercialization right, Celgene would also have the right to elect to participate in up to a specified percentage of certain commercialization activities for product candidates in such program in the Juno Territory, and the Company would have the right to elect to participate in up to a specified percentage of certain commercialization activities for such product candidates in certain major European markets.

For Celgene-originated programs under the collaboration for which the Company exercises its option to obtain an exclusive license, the parties will enter into a co-development and co-commercialization agreement and:

 

    The parties will share global profits and losses from development and commercialization activities with 70% allocated to Celgene and 30% allocated to the Company; and

 

    Celgene will lead global development and commercialization activities, subject to the Company’s right to elect to participate in up to a specified percentage of certain commercialization activities in the Juno Territory under certain circumstances and in certain major European countries.

Furthermore, each of Celgene and the Company will have the exclusive right to exercise options to co-develop and co-commercialize product candidates arising out of programs for which the other party in-licenses or acquires rights that are within the scope of their collaboration, where such rights are available to be granted, with the parties each bearing an equal share of the profits and losses arising out of such programs following the exercise of such option. In general, for such programs where the rights are in-licensed or acquired by the Company and for which Celgene exercises its options, the Company will be the lead party for development and commercialization of product candidates arising from such programs in the Juno Territory, subject to Celgene’s right to elect to participate in certain commercialization activities for such product candidates in the Juno Territory, and Celgene will be the lead party for development and commercialization of product candidates arising in such programs in the Celgene Territory, subject to the Company’s right to elect to participate in certain commercialization activities for such product candidates in certain major European markets. Conversely, for such programs where the rights are in-licensed or acquired by Celgene and for which the Company exercises its options, Celgene will be the lead party for development and commercialization activities for product candidates arising from such programs on a worldwide basis, subject to the Company’s right to elect to participate in certain commercialization activities for such product candidates in the Juno Territory and in certain major European markets. The party exercising an option for these in-licensed or acquired programs is generally required to pay to the other party an upfront payment equal to one half of the costs incurred by other party in connection with the acquisition of rights to such programs .

In addition to an upfront cash payment of approximately $150.2 million under the Collaboration Agreement, Celgene is required to pay to the Company an additional upfront fee if it exercises its option for each of the CD19 Program and the CD22 Program, totaling, if the options are exercised for both programs during the initial opt-in window, $100.0 million. Upon a party’s exercise of the option for any other program (other than certain in-licensed or acquired programs where a party exercises its option at the time such program is acquired), the party exercising the option is required to pay to the other party an upfront payment at the time of exercise of its option, calculated as a multiple of the costs incurred by the other party in relation to the development activities for such program prior to the exercise of the option, with such multiple based on the point in development of such product at which such party exercises such option. For programs for which the parties have entered into a license agreement, the Company will also receive royalties from Celgene, for product candidates arising from the CD19 and CD22 programs, at a percentage in the mid-teens of net sales of such product candidates in the Celgene Territory, and for product candidates arising from other Company programs that are subject to a license agreement, tiered royalties on net sales of such product candidates in the Celgene Territory, at percentages ranging from the high single digits to the mid-teens, calculated based on the stage of development at which Celgene exercises its option for such program.

 

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In June 2015, the Company also entered into a Share Purchase Agreement (the “Purchase Agreement”) with Celgene. Pursuant to the Purchase Agreement, the Company agreed to sell 9,137,672 shares of the Company’s common stock to Celgene at an aggregate cash price of approximately $849.8 million, or $93.00 per share of common stock, at an initial closing (the “Initial Closing”). Beyond the Initial Closing, the Purchase Agreement provides for potential future sales of shares by the Company to Celgene as follows:

 

    First Period Top-Up Rights. After the Initial Closing and until June 29, 2020, Celgene has the annual right, following the filing of each Annual Report on Form 10-K filed by the Company, to purchase additional shares from the Company at a market average price, allowing it to “top up” to an ownership interest equal to 10% of the then-outstanding shares (after giving effect to such purchase), subject to adjustment downward in certain circumstances. If Celgene does not exercise its top-up right in full in any given year, then the percentage of ownership targeted for a top-up stock purchase for the next year will be reduced to Celgene’s percentage ownership at the time of such non-exercise or partial exercise (after giving effect to the issuance of shares in any partial exercise).

 

    First Acquisition Right. During the period beginning on June 29, 2019 and ending on June 28, 2020, subject to Celgene opting in to a certain number of Company programs under the Collaboration Agreement, Celgene will have the right (the “First Acquisition Right”) to purchase up to such number of shares that will allow Celgene to have ownership of 19.99% of the then-outstanding shares of the Company’s common stock (after giving effect to such purchase) at the closing price of the common stock on the principal trading market (currently The NASDAQ Global Select Market) on the date of exercise (the “FAR Base Price”), plus a premium on all shares in excess of the number of shares for which Celgene would then be able to purchase if it then had a top-up right as described in the preceding paragraph.

 

    Second Period Top-Up Rights . After the closing of the purchase of shares upon the exercise of the First Acquisition Right until the SAR Termination Date (as defined below), in the event that Celgene has been diluted after exercising the First Acquisition Right, the Company will, following the filing of each Annual Report on Form 10-K filed by the Company, offer Celgene the right to purchase additional shares from the Company at 105% of market average price, allowing Celgene to “top up” to an ownership interest (after giving effect to such purchase) equal to the percentage ownership of shares that Celgene obtained upon exercise of the First Acquisition Right, subject to adjustment downward in certain circumstances. If Celgene does not exercise its top-up right in full in any year in which it is offered such right by the Company, then the percentage of ownership targeted for a top-up stock purchase for the next year it is offered such top-up right will be reduced to Celgene’s percentage ownership at the time of such non-exercise or partial exercise (after giving effect to the issuance of shares in any partial exercise). The “SAR Termination Date” is the later of (a) June 29, 2025, and (b) the earlier of (x) the date that is 6 months following the date that the conditions to the exercise of the Second Acquisition Right (as defined herein) are satisfied and (y) December 29, 2025.

 

    Second Acquisition Right . During the period beginning on June 29, 2024 and ending on the SAR Termination Date, subject to each of Celgene and the Company opting into a certain number of programs under the Collaboration Agreement, and provided that Celgene exercised the First Acquisition Right so as to obtain a percentage ownership of 17% of the Company, Celgene will have the right (the “Second Acquisition Right”) to purchase up to such number of shares that will allow Celgene to have ownership of 30% of the then-outstanding shares of the Company’s common stock (after giving effect to such purchase) at the closing price of the common stock on the principal trading market on the date of exercise (the “SAR Base Price”), plus a premium on all shares in excess of the number of shares for which Celgene would then be able to purchase if it then had a top-up right as described in the preceding paragraph.

 

    Final Top-Up Rights . Following the closing of the purchase of shares upon the exercise of the Second Acquisition Right and until the Collaboration Agreement expires or is terminated, Celgene would have the annual right, in the event that Celgene has been diluted after exercising the Second Acquisition Right, following the filing of each Annual Report on Form 10-K filed by the Company, to purchase additional shares from the Company at a price equal to 105% of market average price, allowing it to “top up” to the percentage ownership it had attained upon exercising the Second Acquisition Right, less 250 basis points, subject to adjustment downward in certain circumstances. If Celgene does not exercise its top-up right in full in any given year, then the percentage of ownership targeted for a top-up stock purchase for the next year will be reduced to Celgene’s percentage ownership at the time of such non-exercise or partial exercise (after giving effect to the issuance of shares in any partial exercise). These rights and the other described top-up rights, as well as the First Acquisition Right and Second Acquisition Right, may be limited or eliminated in certain circumstances when and if Celgene disposes of any of its shares.

Each closing of the sale of shares to Celgene is subject to customary closing conditions, including termination or expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. The Purchase Agreement also limits the aggregate number of shares that may be issued thereunder to 19.99% of the Company’s common stock outstanding immediately prior to the entry into the Purchase Agreement, unless

 

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stockholder approval is obtained for additional issuances of Company stock in accordance with NASDAQ rules. The Company has agreed to submit the additional equity issuances for approval by its stockholders at the Company’s 2016 annual meeting of stockholders.

The Collaboration Agreement became effective on July 31, 2015, in connection with which the Company received an upfront cash payment of $150.2 million. On August 4, 2015 the Initial Closing under the Purchase Agreement occurred, and the Company sold 9,137,672 shares of the Company’s common stock to Celgene for an aggregate cash purchase price of approximately $849.8 million.

Fred Hutchinson Cancer Research Center

In October 2013, the Company entered into a collaboration agreement with FHCRC, focused on research and development of cancer immunotherapy products. The agreement has a six year term and can be extended if mutually agreed upon. The research will be conducted in accordance with a research plan and budget approved by the parties. The Company is committed to aggregate research funding of $9.3 million over a period of six years relating to the research and development of cellular immunology products. The Company recognized $2.4 million and $1.7 million of research and development expenses in connection with its collaboration agreement with FHCRC for the three months ended June 30, 2015 and 2014, respectively, and $4.4 million and $2.2 million for the six months ended June 30, 2015 and 2014, respectively.

The Company granted FHCRC rights to certain share-based success payments. Under the terms of this arrangement, the Company may be required to make success payments to FHCRC based on increases in the estimated fair value of the Company’s common stock. The potential payments are based on multiples of increased value ranging from 5x to 40x based on a comparison of the fair value of the common stock relative to its original $4.00 issuance price. The payments are based on whether the value of the Company’s common stock meets or exceeds certain specified threshold values ascending from $20.00 per share to $160.00 per share, in each case subject to adjustment for any stock dividend, stock split, combination of shares, or other similar events. In June 2014, the Company entered into an agreement with FHCRC in which it can offset certain indirect costs related to the collaboration projects conducted by FHCRC against any success payments. The aggregate success payments to FHCRC are not to exceed $375 million which would only occur upon a 40x increase in value. The term of the success payment agreement ranges from eight to eleven years depending upon when or if the company receives FDA approval of certain of its product candidates as specified in the agreement.

The following table summarizes the potential success payments, which are payable in cash or publicly-traded equity at the Company’s discretion:

 

Multiple of Equity Value at issuance

     5.0x         7.5x         10.0x         15.0x         20.0x         25.0x         30.0x         35.0x         40.0x   

Per share common stock price required for payment

   $ 20.00       $ 30.00       $ 40.00       $ 60.00       $ 80.00       $ 100.00       $ 120.00       $ 140.00       $ 160.00   

Success payment(s) (in millions)

   $ 10       $ 25       $ 40       $ 50       $ 50       $ 50       $ 50       $ 50       $ 50   

The success payments will be owed if the value of our common stock on the contractually specified valuation measurement dates during the term of the success payment agreement equals or exceeds the above outlined multiples. The valuation measurement dates are triggered by events which include an initial public offering of the Company’s stock, a merger, an asset sale, or the sale of the majority of the shares held by certain of the Company’s stockholders or the last day of the term of the success payment agreement. If a higher success payment tier is first met at the same time a lower tier is first met, both tiers will be owed. Any previous success payments made to FHCRC are credited against the success payment owed as of any valuation measurement date, so that FHCRC does not receive multiple success payments in connection with the same threshold. A payment may be triggered on the first anniversary of the closing of the IPO (or the date that is 90 days following such anniversary, at the Company’s option, if the Company is contemplating a capital market transaction during such 90 day period). The value of any such success payment will be determined by the average trading price of a share of the Company’s common stock over the consecutive 90-day period preceding such determination date.

 

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The Company’s liability for share-based success payments under the FHCRC collaboration is carried at fair value and recognized as expense over the term of the six-year collaboration agreement. To determine the estimated fair value of the success payment liability the Company uses a Monte Carlo simulation methodology which models the future movement of stock prices based on several key variables. The following variables were incorporated in the calculation of the estimated fair value of the success payment liability as of June 30, 2015:

 

Assumptions

   June 30, 2015      December 31, 2014  

Fair value of common stock

   $ 53.33       $ 52.22   

Risk free interest rate

     1.92%-2.28%         1.94%-2.16%   

Expected volatility

     75%         75%   

Expected term (years)

     6.30-9.30         6.79-9.79   

The computation of expected volatility was estimated using a combination of available information about the historical volatility of stocks of similar publicly-traded companies for a period matching the expected term assumption and our historical volatility. The risk free interest rate and expected term assumptions ranged from 1.92% to 2.28% and 6.30 to 9.30 years, respectively, depending on the estimated timing of FDA approval. In addition, the Company incorporated the estimated number and timing of valuation measurement dates in the calculation of the success payment liability. As of June 30, 2015 and December 31, 2014, the estimated fair value of the total success payment obligation to FHCRC was approximately $149.4 million and $139.1 million, respectively. The Company recognized research and development expense of $2.8 million and $0.2 million in the three months ended June 30, 2015 and 2014, respectively, and $29.9 million and $0.3 million in the six months ended June 30, 2015 and 2014, respectively. The expense associated with the success payment obligation is amortized to research and development expense using the accelerated attribution method over the service period. The success payment liabilities as of June 30, 2015 and December 31, 2014 was $91.2 million and $61.2 million, respectively. If the fair value of the Company’s common stock at the first valuation measurement date in December 2015 remains at its June 30, 2015 value of $53.33, the Company will be required to make a $75 million payment to FHCRC, payable in cash or stock at the Company’s discretion.

In October 2013, the Company entered into a license agreement with FHCRC, pursuant to which the Company acquired an exclusive, worldwide, sublicensable license under certain patent rights, and a non- exclusive, worldwide, sublicensable license under certain technology, to research, develop, manufacture, improve, and commercialize products and processes covered by such patent rights or incorporating such technology for all therapeutic uses for the treatment of human cancer. The patents and patent applications covered by this agreement are directed, in part, to CAR constructs, including target specific constructs and customized spacer regions, TCR constructs, and their use for immunotherapy. The Company classifies on the condensed consolidated statement of operations payments accrued or made under its licensing arrangements based on the underlying nature of the expense. Expenses related to the reimbursement of legal and patent costs are classified as general and administrative because the nature of the expense is not related to the research or development of the technologies the Company is licensing.

The Company also agreed to pay FHCRC annual maintenance fees, milestone payments, and royalties as a percentage of net sales of licensed products. After five years the Company is obligated to pay a $0.1 million minimum annual royalty, with such payments creditable against royalties.

Milestone payments to FHCRC of up to an aggregate of $6.8 million per licensed product, including JCAR014 and JCAR017, are triggered upon the achievement of specified clinical and regulatory milestones and are not creditable against royalties. The Company may terminate the license agreement at any time with advance written notice.

Memorial Sloan Kettering Cancer Center

In November 2013, the Company entered into a sponsored research agreement with MSK, focused on research and development relating to chimeric antigen receptor T cell technology. The research will be conducted in accordance with a research plan and budget approved by the parties. The Company is committed to aggregate research funding of $2.2 million over a period of five years. The Company also entered into a master clinical study agreement, with MSK, pursuant to which the Company committed to provide aggregate funding to MSK of up to $7.2 million for six clinical studies to be conducted at MSK on the Company’s behalf. Each such study will be conducted in accordance with a written plan and budget and protocol approved by the parties. The Company recognized $1.8 million and $0.3 million of research and development expenses in connection with its collaboration agreement with MSK for the three months ended June 30, 2015 and 2014, respectively, and $2.8 million and $0.6 million for the six months ended June 30, 2015 and 2014, respectively.

The Company granted MSK rights to certain share-based success payments. Under the terms of this arrangement, the Company may be required to make success payments to MSK based on the increases in the estimated fair value of the Company’s common stock. The potential payments are based on multiples of increased value ranging from

 

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10x to 30x based on a comparison of the fair value of the common stock relative to its original $4.00 issuance price. The payments are based on whether the value of the Company’s common stock meets or exceeds certain specified threshold values ascending from $40.00 per share to $120.00 per share, in each case subject to adjustment for any stock dividend, stock split, combination of shares, or other similar events. The aggregate success payments to MSK are not to exceed $150 million, which would only occur upon a 30x increase in value. The term of the success payment agreement ranges from eight to eleven years depending upon when or if the company receives FDA approval of certain of its product candidates as specified in the agreement.

The following table summarizes the potential success payments, which are payable in cash or publicly-traded equity at the Company’s discretion:

 

Multiple of Equity Value at issuance

     10.0x         15.0x         30.0x   

Per share common stock price required for payment

   $ 40.00       $ 60.00       $ 120.00   

Success payment(s) (in millions)

   $ 10       $ 70       $ 70   

The success payments will be owed, if the value of our common stock on contractually specified valuation measurement dates equals or exceeds the above outlined multiples. The valuation measurement dates are triggered by events which include an initial public offering of the Company’s stock, a merger, an asset sale, or the sale of the majority of the shares held by certain of the Company’s stockholders or the last day of the term of the success payment agreement. If a higher success payment tier is met at the same time a lower tier is met, both tiers will be owed. Any previous success payments made to MSK are credited against the success payment owed as of any valuation measurement date, so that MSK does not receive multiple success payments in connection with the same threshold. A payment may be triggered on the first anniversary of the closing of the IPO (or the date that is 90 days following such anniversary, at the Company’s option, if the Company is contemplating a capital market transaction during such 90 day period). The value of any such success payment will be determined by the average trading price of a share of the Company’s common stock over the consecutive 90-day period preceding such determination date.

The Company’s liability for share-based success payments under the MSK collaboration is carried at fair value and recognized as expense over the term of the five-year collaboration agreement. To determine the estimated fair value of the success payment liability the Company uses a Monte Carlo simulation methodology which models the future movement of stock prices based on several key variables. The following variables were incorporated in the calculation of the estimated fair value of the success payment liability as of June 30, 2015:

 

Assumptions

   June 30, 2015      December 31, 2014  

Fair value of common stock

   $ 53.33       $ 52.22   

Risk free interest rate

     1.94%-2.29%         1.95%-2.16%   

Expected volatility

     75%         75%   

Expected term (years)

     6.40-9.40         6.89-9.89   

The computation of expected volatility was estimated using a combination of available information about the historical volatility of stocks of similar publicly-traded companies for a period matching the expected term assumption and our historical volatility. The risk free interest rate and expected term assumptions ranged from 1.94% to 2.29% and 6.40 to 9.40 years, respectively, depending on the estimated timing of FDA approval. In addition, the Company incorporated the estimated number and timing of valuation measurement dates in the calculation of the success payment liability. As of June 30, 2015 and December 31, 2014, the estimated fair value of the total success payment obligation to MSK was approximately $62.0 million and $56.8 million, respectively. The Company recognized research and development expense of $1.2 million and $0.1 million in the three months ended June 30, 2015 and 2014, respectively, and $12.9 million and $0.1 million in the six months ended June 30, 2015 and 2014, respectively. The expense associated with the success payment obligation is amortized to research and development expense using the accelerated attribution method over the service period. The success payment liabilities as of June 30, 2015 and December 31, 2014 was $36.6 million and $23.7 million, respectively. If the fair value of the Company’s common stock at the first valuation measurement date in December 2015 remains at its June 30, 2015 value of $53.33, the Company will be required to make a $10 million payment to MSK, payable in cash or stock at the Company’s discretion.

In November 2013, the Company entered into a license agreement with MSK, pursuant to which the Company acquired a worldwide, sublicensable license to specified patent rights and intellectual property rights related to certain know-how to develop, make, and commercialize licensed products and to perform services for all therapeutic

 

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and diagnostic uses, which license is exclusive with respect to such patent rights and tangible materials within such know-how, and non-exclusive with respect to such know-how and related intellectual property rights. The patents and patent applications covered by this agreement are directed, in part, to CAR constructs, including bispecific and armored CARs, and their use for immunotherapy.

The Company also agreed to pay MSK milestone payments and royalties as a percentage of net sales of licensed products and services by us or our affiliates and sublicensees. After five years the Company is obligated to pay a $0.1 million minimum annual royalty, with such payments credible against royalties.

Milestone payments to MSK of up to an aggregate of $6.8 million per licensed product, including JCAR015, are triggered upon the achievement of specified clinical and regulatory milestones and are not creditable against royalties. The Company may terminate the license agreement at any time with advance written notice, but if the Company has commenced the commercialization of licensed products, the Company can only terminate at will if it ceases all development and commercialization of licensed products.

St. Jude Children’s Research Hospital/Novartis

In December 2013, the Company entered into an agreement with St. Jude (“St. Jude License Agreement”), pursuant to which the Company (1) obtained control over, and the obligation to pursue and defend, St. Jude’s causes of action in Trustees of the University of Pennsylvania v. St. Jude Children’s Research Hospital, Civil Action No. 2:13-cv-01502-SD (E.D. Penn.), which concerned both U.S. Patent No. 8,399,645 (the “’645 Patent”) and a contractual dispute between St. Jude and the Trustees of the University of Pennsylvania (“Penn”) and (2) acquired an exclusive, worldwide, royalty-bearing license under certain patent rights owned by St. Jude, including the ’645 Patent, to develop, make, and commercialize licensed products and services for all therapeutic, diagnostic, preventative, and palliative uses. The patents and patent applications covered by this agreement are directed, in part, to CAR constructs capable of signaling both a primary and a costimulatory pathway. Together with St. Jude, the Company was a party in, and was adverse to, Penn and Novartis Pharmaceutical Corporation (“Novartis”) in that litigation (the “Penn litigation”), which was settled by the parties in April 2015.

The Company also agreed to pay to St. Jude milestone payments and royalties as a percentage of net sales of licensed products and services, and a percentage of St. Jude’s reasonable legal fees incurred in connection with the Penn litigation. The Company is obligated to pay a $0.1 million minimum annual royalty for the first two years of the agreement and a $0.5 million minimum annual royalty thereafter.

Milestone payments to St. Jude of up to an aggregate of $62.5 million are triggered upon the achievement of specified clinical, regulatory, and commercialization milestones for licensed products, including JCAR014 or JCAR017, and are not creditable against royalties. The Company can terminate the agreement for any reason upon advance written notice.

In April 2015, the Company and St. Jude agreed to settle the Penn litigation with Penn and Novartis. In connection with such settlement, in April 2015, the Company entered into a sublicense agreement (the “Penn/Novartis Sublicense Agreement”) with Penn and an affiliate of Novartis pursuant to which the Company granted to Novartis a non-exclusive, royalty-bearing sublicense under certain patent rights, including the ‘645 Patent, to develop, make, and commercialize licensed products and licensed services for all therapeutic, diagnostic, preventative, and palliative uses. This sublicense is not sublicensable without the Company’s prior written consent, although Novartis may authorize third parties to act on its behalf with respect to the manufacture, development, or commercialization of Novartis’ licensed products and licensed services. Under the Penn/Novartis Sublicense Agreement, Novartis paid the Company an initial license fee of $12.3 million, which was recorded as revenue for the three and six months ended June 30, 2015. In addition, Novartis is also required to pay mid-single digit royalties on the U.S. net sales of products and services related to the disputed contract and patent claims (the “Royalty Payments”), a low double digit percentage of the royalties Novartis pays to Penn for global net sales of those products (the “Penn Royalty Payments”), and milestone payments upon the achievement of specified clinical, regulatory, and commercialization milestones for licensed products (the “Milestone Payments”). If the Company achieves any of the milestones with respect to its own products leveraging the same patents, prior to Novartis, the related Milestone Payment will be reduced by 50%. In addition, if the Company achieves any milestone after Novartis, the Company will reimburse Novartis 50% of any Milestone Payment previously paid by Novartis to the Company in respect of such milestone. These milestones largely overlap with the milestones for which the Company may owe a payment to St. Jude under the St. Jude License Agreement and the Milestone Payments would in effect serve to partially offset the Company’s obligations to St. Jude with respect to such milestones.

 

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Novartis may terminate the Penn/Novartis Sublicense Agreement at will upon advance written notice to the Company.

Under a separate agreement with St. Jude, the Company agreed to pay St. Jude $5.3 million as reimbursement of litigation expenses. The Company and St. Jude also amended the St. Jude License Agreement to provide the terms by which the Penn/Novartis Sublicense Agreement would be treated under the St. Jude License Agreement.

Seattle Children’s Research Institute

In February 2014, the Company entered into a sponsored research agreement with Seattle Children’s Research Institute (“SCRI”) pursuant to which the Company committed to provide research funding to SCRI totaling not less than $2.1 million over a period of five years. Effective April 1, 2015, the sponsored research agreement was amended to extend the term of the agreement through April 2020, thereby increasing the minimum funding obligations by an additional $0.3 million. The research will be conducted in accordance with a written plan and budget approved by the parties. In November 2014, the Company entered into a Letter of Intent with SCRI pursuant to which the Company committed to provide clinical trial funding to SCRI totaling not less than $4.1 million over a period of five years. The Company recognized $0.2 million of research and development expenses in connection with its sponsored research agreement with SCRI for the three months ended June 30, 2015 and $0.3 million for the six months ended June 30, 2015. The Company recognized expense of $0.1 million in connection with its sponsored research agreement with SCRI for the six months ended June 30, 2014.

In February 2014, the Company entered into a license agreement with SCRI that grants the Company an exclusive, worldwide, royalty-bearing sublicensable license to certain patent rights to develop, make and commercialize licensed products and to perform licensed services for all therapeutic, prophylactic, and diagnostic uses. Effective June 2015, the license agreement was amended to include additional patent rights. The Company paid $0.2 million in the six months ended June 30, 2014 for the upfront license fee, which was recorded as research and development expense.

The Company is required to pay to SCRI annual license maintenance fees, creditable against royalties and milestone payments due to SCRI, of $50,000 per year for the first five years and $0.2 million per year thereafter.

The Company also agreed to pay SCRI milestone payments and royalties as a percentage of net sales of licensed products and licensed services. Milestone payments to SCRI of up to an aggregate of $16.3 million per licensed product, including JCAR014 and JCAR017, are triggered upon the achievement of specified clinical, regulatory, and commercialization milestones and are not creditable against future royalties. The Company may terminate the license agreement for any reason with advance written notice.

Opus Bio

In December 2014, the Company entered into a license agreement with Opus Bio, Inc. pursuant to which the Company was granted an exclusive, worldwide, sublicensable license under certain patent rights and data to research, develop, make, have made, use, have used, sell, have sold, offer to sell, import and otherwise exploit products that incorporate or use engineered T cells directed against CD22 and that are covered by such patent rights or use or incorporate such data. Certain of the licensed patent rights are in-licensed by Opus Bio from the National Institutes of Health (“NIH”). Under the agreement, the Company is required to use commercially reasonable efforts to research, develop, and commercialize licensed products. Such development must be in accordance with the timelines provided in the license agreement for achievement of certain clinical, regulatory, and commercial benchmarks, and with the development plans set forth in Opus Bio’s agreements with the NIH.

Upon achievement of certain clinical, regulatory, and commercial milestones set forth in the license agreement, the Company will be obligated to pay Opus Bio additional consideration. The consideration due upon achievement of the first three clinical milestones would consist of additional shares of our common stock in an amount equal to the dollar value specified for the applicable milestone, which is $52.5 million in the aggregate for the three milestones, divided by the greater of $10.92 and the arithmetic average of the daily volume- weighted average price of our common stock on The NASDAQ Global Select Market over the 30 trading days preceding the achievement of the milestone, up to a maximum of 4,807,692 shares in the aggregate (this minimum per share value and maximum number of shares subject, in each case, to adjustment for any stock dividend, stock split, combination of shares, or other similar events). Upon achievement of any subsequent milestones, the Company will be obligated to pay Opus Bio cash consideration, which potential milestone payments total $215.0 million in the aggregate. Once certain milestones have been achieved, the Company will be required to spend at least $2.5 million per year on development and commercialization of licensed products.

 

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The license agreement further provides that the Company is required to pay to Opus Bio tiered royalties based on annual net sales of licensed products by us and by sublicensees. The Company will also be required to make certain pass-through payments owed by Opus Bio to NIH under its NIH license agreements, including certain patent costs, development and commercial milestones of up to $2.8 million in the aggregate, royalties based on annual net sales. The Company may terminate the agreement at will upon advance written notice.

Fate Therapeutics

In May 2015, the Company entered into a collaboration and license agreement with Fate Therapeutics, Inc. (“Fate Therapeutics”), to identify and utilize small molecules to modulate the Company’s genetically-engineered T cell product candidates to improve their therapeutic potential for cancer patients. The Company paid an upfront fee of $5.0 million in cash and purchased 1,000,000 shares in Fate Therapeutics common stock at a purchase price of $8.00 per share, representing an approximately 5% ownership interest in Fate Therapeutics. The $5.0 million upfront fee and the premium paid for the common stock of $0.8 million were recorded as research and development expense in the three and six months ended June 30, 2015. The investment in Fate Therapeutics is classified as available-for-sale, and reported at fair value with unrealized gains and losses included in accumulated other comprehensive income (loss). The Company also agreed to provide Fate Therapeutics with research funding of $2.0 million per year during the initial four year research term. The Company has an option to extend the collaboration for two additional years, subject to payment of an extension fee and additional annual research funding. Under the collaboration and license agreement, for each product developed by the Company that incorporates modulators identified through the collaboration, the Company will also be required to pay Fate Therapeutics target selection fees and milestone payments upon achievement of clinical, regulatory, and commercial milestones, as well as low single-digit royalties on net sales. The Company can terminate the agreement at will upon advance written notice, but such termination may not be effective any earlier than May 2017. In addition to the upfront fee of $5.0 million and the premium paid for the common stock of $0.8 million, the Company recognized $0.3 million of research and development expenses in connection with its collaboration agreement with Fate Therapeutics for the three and six months ended June 30, 2015.

Editas Medicine

In May 2015, the Company entered into a collaboration and license agreement with Editas Medicine, Inc. (“Editas”), to pursue research programs utilizing Editas’ genome editing technologies with Juno’s CAR and TCR technologies. The Company paid an upfront fee of $25.0 million in cash, which was recorded as research and development expense in the three and six months ended June 30, 2015. The Company also agreed to provide Editas with research funding of up to $22.0 million over the initial five year research term. The Company and Editas may mutually agree to extend the collaboration for two additional years, subject to payment of extension fees. Editas is also eligible to receive future research, regulatory, and commercial sales milestones for each program. Following the approval of any products resulting from the alliance, Editas is also eligible to receive tiered royalties. The Company can terminate the agreement at will upon advance written notice. In addition to the upfront fee of $25.0 million, the Company recognized $0.2 million of research and development expenses in connection with its collaboration agreement with Editas for the three and six months ended June 30, 2015.

 

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4. Cash Equivalents and Marketable Securities

The following tables summarize the estimated fair value of our cash equivalents and marketable securities and the gross unrealized holding gains and losses (in thousands):

 

     June 30, 2015  
     Amortized Cost      Gross
Unrealized
Holding Gains
     Gross
Unrealized
Holding Losses
     Estimated Fair
Value
 

Cash equivalents:

           

Money market funds

   $ 7,651       $ —         $ —         $ 7,651   

Commercial paper

     6,499         —           —           6,499   

U.S. government and agency securities

     8,039         —           (1      8,038   

Corporate debt securities

     3,402         —           (1      3,401   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total cash equivalents

     25,591         —           (2      25,589   
  

 

 

    

 

 

    

 

 

    

 

 

 

Marketable securities:

           

U.S. government and agency securities

     201,234         39         (9      201,264   

Corporate debt securities

     62,821         1         (31      62,791   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total marketable securities

     264,055         40         (40      264,055   
  

 

 

    

 

 

    

 

 

    

 

 

 

Long-term marketable securities:

           

U.S. government and agency securities

     1,356         —           —           1,356   

Corporate debt securities

     2,015         —           (2      2,013   

Equity securities

     7,190         —           (720      6,470   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total long-term marketable securities

   $ 10,561       $ —         $ (722    $ 9,839   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

     December 31, 2014  
     Amortized Cost      Gross
Unrealized
Holding Gains
     Gross
Unrealized
Holding Losses
     Estimated Fair
Value
 

Cash equivalents:

           

Money market funds

   $ 223,745       $ —         $ —         $ 223,745   

Commercial paper

     13,294         —           —           13,294   

U.S. government and agency securities

     7,582         —           —           7,582   

Corporate debt securities

     1,702         —           —           1,702   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total cash equivalents

     246,323         —           —           246,323   
  

 

 

    

 

 

    

 

 

    

 

 

 

Marketable securities:

           

Commercial paper

     1,999         —           —           1,999   

U.S. government and agency securities

     47,868         —           (21      47,847   

Corporate debt securities

     29,863         —           (37      29,826   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total marketable securities

     79,730         —           (58      79,672   
  

 

 

    

 

 

    

 

 

    

 

 

 

Long-term marketable securities:

           

U.S. government and agency securities

     34,898         —           (25      34,873   

Corporate debt securities

     3,544         1         (7      3,538   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total long-term marketable securities

   $ 38,442       $ 1       $ (32    $ 38,411   
  

 

 

    

 

 

    

 

 

    

 

 

 

The following table summarizes the gross unrealized holding losses and fair value for investments in an unrealized loss position, and the length of time that individual securities have been in a continuous loss position (in thousands):

 

     June 30, 2015  
     Less than 12 Months     12 Months or Greater      Total  
     Fair Value      Unrealized
Losses
    Fair Value      Unrealized
Losses
     Fair Value      Unrealized
Losses
 

Marketable securities:

                

U.S. government and agency securities

   $ 78,510       $ (9   $ —         $ —         $ 78,510       $ (9

Corporate debt securities

     51,252         (31     —           —           51,252         (31
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

Total marketable securities

     129,762         (40     —           —           129,762         (40
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

Long-term marketable securities:

                

Corporate debt securities

     2,013         (2     —           —           2,013         (2

Equity securities

     6,470         (720     —           —           6,470         (720
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

Total long-term marketable securities

   $ 8,483       $ (722   $ —         $ —         $ 8,483       $ (722
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

 

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Table of Contents
     December 31, 2014  
     Less than 12 Months     12 Months or Greater      Total  
     Fair Value      Unrealized
Losses
    Fair Value      Unrealized
Losses
     Fair Value      Unrealized
Losses
 

Marketable securities:

                

U.S. government and agency securities

   $ 43,332       $ (21   $ —         $ —         $ 43,332       $ (21

Corporate debt securities

     26,611         (37     —           —           26,611         (37
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

Total marketable securities

     69,943         (58     —           —           69,943         (58
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

Long-term marketable securities:

                

U.S. government and agency securities

     33,873         (25     —           —           33,873         (25

Corporate debt securities

     2,003         (7     —           —           2,003         (7
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

Total long-term marketable securities

   $ 35,876       $ (32   $ —         $ —         $ 35,876       $ (32
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

The Company evaluated its securities for other-than-temporary impairment and considers the decline in market value for the securities to be primarily attributable to current economic and market conditions. For the debt securities, it is not more likely than not that the Company will be required to sell the securities, and the Company does not intend to do so prior to the recovery of the amortized cost basis. The unrealized loss for equity securities is related to the Company’s investment in Fate Therapeutics. The Company has evaluated the near-term prospects of the Fate Therapeutics investment in relation to the severity and duration of the impairment and based on that evaluation, the Company has the ability and intent to hold this investment until a recovery of fair value. Based on this analysis, these marketable securities were not considered to be other-than-temporarily impaired as of June 30, 2015 and December 31, 2014.

All of our marketable securities have an effective maturity date of two years or less and are available for use and therefore classified as available-for-sale.

5. Fair Value Measurements

The following table sets forth the fair value of the Company’s financial assets and liabilities measured at fair value on a recurring basis based on the three-tier fair value hierarchy (in thousands):

 

     June 30, 2015  
     Level 1      Level 2      Level 3      Total  

Financial Assets:

           

Money market funds

   $ 7,651       $ —         $ —         $ 7,651   

Commercial paper

     —           6,499         —           6,499   

U.S. government and agency securities

     —           210,658         —           210,658   

Corporate debt securities

     —           68,205         —           68,205   

Equity securities

     6,470         —           —           6,470   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial assets

   $ 14,121       $ 285,362       $ —         $ 299,483   
  

 

 

    

 

 

    

 

 

    

 

 

 

Financial Liabilities:

           

Fair value of success payments liabilities attributable to the elapsed service period

   $ —         $ —         $ 127,791       $ 127,791   

Contingent consideration

     —           —           32,686         32,686   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities

   $ —         $ —         $ 160,477       $ 160,477   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

     December 31, 2014  
     Level 1      Level 2      Level 3      Total  

Financial Assets:

           

Money market funds

   $ 223,745       $ —         $ —         $ 223,745   

Commercial paper

     —           15,293         —           15,293   

U.S. government and agency securities

     —           90,302         —           90,302   

Corporate debt securities

     —           35,066         —           35,066   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial assets

   $ 223,745       $ 140,661       $ —         $ 364,406   
  

 

 

    

 

 

    

 

 

    

 

 

 

Financial Liabilities:

           

Fair value of success payments liabilities attributable to the elapsed service period

   $ —         $ —         $ 84,920       $ 84,920   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities

   $ —         $ —         $ 84,920       $ 84,920   
  

 

 

    

 

 

    

 

 

    

 

 

 

The Company measures the fair value of money market funds based on quoted prices in active markets for identical assets or liabilities. The Level 2 marketable securities include U.S. government and agency securities, corporate debt securities, and commercial paper and are valued either based on recent trades of securities in inactive markets or based on quoted market prices of similar instruments and other significant inputs derived from or corroborated by observable market data.

 

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The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial liabilities (in thousands):

 

     Success Payments
Liabilities
     Contingent
Consideration
     Total  

Balance at December 31, 2014

   $ 84,920       $ —         $ 84,920   

Additions

     —           37,188         37,188   

Changes in fair value (1)

     42,871         (80      42,791   
  

 

 

    

 

 

    

 

 

 

Balance at June 30, 2015

   $ 127,791       $ 37,108       $ 164,899   
  

 

 

    

 

 

    

 

 

 

 

(1) Changes in fair value for success payments liabilities and contingent consideration is recorded in research and development expense in the condensed consolidated statements of operations.

As of June 30, 2015, the estimated fair value of the success payment obligations was approximately $211.4 million, of which $127.8 million represents the portion attributable to the valuation measurement dates and the associated elapsed service period. See Note 3, Collaboration and License Agreements, for additional discussion of estimated fair value of the success payment obligations.

In connection with the acquisitions of Stage and X-Body, the Company also agreed to pay additional amounts based on the achievement of certain milestones. This contingent consideration is measured at fair value and is based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The valuation of contingent consideration uses assumptions the Company believes would be made by a market participant. The Company assesses these estimates on an on-going basis as additional data impacting the assumptions is obtained.

Contingent consideration may change significantly as development progresses and additional data are obtained, impacting the Company’s assumptions regarding probabilities of successful achievement of related milestones used to estimate the fair value of the liability and the timing in which they are expected to be achieved. In evaluating the fair value information, judgment is required to interpret the market data used to develop the estimates. The estimates of fair value may not be indicative of the amounts that could be realized in a current market exchange. Accordingly, the use of different market assumptions and/or different valuation techniques could result in materially different fair value estimates.

The significant unobservable inputs used in the measurement of fair value of the Company’s contingent consideration are probabilities of successful achievement of the milestones, the period in which these milestones are expected to be achieved ranging from 2015 to 2035, and a discount rate of 15.4%. Significant increases or decreases in any of the probabilities of success would result in a significantly higher or lower fair value measurement, respectively. Significant increases or decreases in these other inputs would result in a significantly lower or higher fair value measurement, respectively.

As of June 30, 2015, the estimated fair value of the contingent consideration associated with the Stage acquisition was $28.1 million. The Company recognized a gain of $0.1 million in research and development expense in the six months ended June 30, 2015 related to the change in fair value of the contingent consideration. As of June 30, 2015, the estimated fair value of the contingent consideration associated with the X-Body acquisition was $8.9 million. As the value was unchanged from the acquisition date, the Company did not recognize an expense in the six months ended June 30, 2015 related to the change in fair value of the contingent consideration.

 

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6. Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):

 

     June 30, 2015      December 31, 2014  

Accrued construction in progress

   $ 6,031       $ —     

Accrued legal expenses

     5,562         4,309   

Accrued research and development expenses

     3,895         2,724   

Accrued clinical expenses

     3,301         564   

Accrued bonus expense

     1,982         3,106   

Accrued employee expenses

     1,227         531   

Accrued offering costs

     —           1,456   

Other

     4,343         1,887   
  

 

 

    

 

 

 

Total accrued liabilities

   $ 26,341       $ 14,577   
  

 

 

    

 

 

 

7. Build-to-Suit Lease Obligation

In February 2015, the Company entered into a lease for an approximately 68,000 square foot manufacturing facility in Bothell, Washington, which lease commenced in March 2015. The Company is responsible for the leasehold improvements required to remodel the facility and bears the majority of the construction risk. ASC 840-40, Leases – Sale-Leaseback Transactions , requires the Company to be considered the owner of the building solely for accounting purposes during the construction period, even though it is not the legal owner. In connection with the accounting for this transaction, the Company capitalized $9.9 million as a build-to-suit property within property and equipment, net and recognized a corresponding build-to-suit lease obligation for the same amount.

The Company bifurcates its lease payments into a portion allocated to the building and a portion allocated to the parcel of land on which the building has been built. The portion of the lease payments allocated to the land is treated for accounting purposes as operating lease payments, and therefore is recorded as rent expense in the condensed consolidated statement of operations. The portion of the lease payments allocated to the building is further bifurcated into a portion allocated to interest expense and a portion allocated to reduce the build-to-suit lease obligation.

At June 30, 2015, $0.3 million of the build-to-suit lease obligation, representing the expected reduction in the liability over the next twelve months, is classified as a current liability and the remaining $9.5 million is classified as a non-current liability on the balance sheet.

8. Stock-Based Compensation

Restricted Stock and RSUs

A summary of the Company’s restricted stock and RSU activity for the six months ended June 30, 2015 is as follows:

 

     Shares      Weighted
Average Fair
Value at Date of
Grant per Share
 

Unvested shares as of December 31, 2014

     8,352,714       $ 1.46   

Granted

     158,516         50.98   

Vested

     (1,647,445      0.33   

Forfeited

     (26,250      0.60   
  

 

 

    

 

 

 

Unvested shares as of June 30, 2015

     6,837,535       $ 1.45   
  

 

 

    

 

 

 

Management estimates expected forfeitures and recognizes compensation costs only for those equity awards expected to vest.

For the three months ended June 30, 2015 and 2014, the Company recognized $2.9 million and $1.2 million, respectively, in compensation cost related to vested restricted stock, of which $1.9 million and $0.5 million, respectively, was related to service providers other than our employees, scientific founders, and directors, including $1.7 million and $0.4 million, respectively, for a former co-founding director who became a consultant upon his

 

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Table of Contents

departure from the board of directors. Of the compensation cost for the three months ended June 30, 2015 and 2014 related to vested restricted stock, $2.1 million and $0.2 million, respectively, was classified as research and development expense and $0.8 million and $1.0 million, respectively, was classified as general and administrative expense.

For the six months ended June 30, 2015 and 2014, the Company recognized $6.2 million and $1.6 million, respectively, in compensation cost related to vested restricted stock, of which $3.9 million and $0.5 million, respectively, was related to service providers other than our employees, scientific founders, and directors, including $3.6 million and $0.5 million, respectively, for a former co-founding director who became a consultant upon his departure from the board of directors. Of the compensation cost for the six months ended June 30, 2015 and 2014 related to vested restricted stock, $4.8 million and $0.3 million, respectively, was classified as research and development expense and $1.4 million and $1.3 million, respectively, was classified as general and administrative expense.

As of June 30, 2015, there was $16.0 million of total unrecognized compensation cost related to non-vested restricted stock and RSUs held by employees, scientific founders, and directors. As of June 30, 2015, the Company expects to recognize these costs over a remaining weighted average period of 2.77 years.

Stock Options

A summary of the Company’s stock option activity for the six months ended June 30, 2015 is as follows:

 

     Number of
Stock Options
     Weighted
Average
Exercise
Price
     Weighted
Average
Remaining
Contractual
Life
     Aggregate
Intrinsic
Value (in thousands)
 

Oustanding as of December 31, 2014

     2,720,351       $ 7.23         9.75         122,390   

Granted

     1,788,303         49.92         

Exercised

     (52,053      7.07         

Cancelled

     (3,500      59.50         
  

 

 

    

 

 

    

 

 

    

 

 

 

Oustanding as of June 30, 2015

     4,453,101       $ 24.34         9.46       $ 130,398   
  

 

 

    

 

 

    

 

 

    

 

 

 

Exercisable as of June 30, 2015

     407,581       $ 12.92         9.31       $ 16,471   
  

 

 

    

 

 

    

 

 

    

 

 

 

The fair value of each stock option granted has been determined using the Black-Scholes option pricing model. The material factors incorporated in the Black-Scholes model in estimating the fair value of the options granted to employees and consultants during the six months ended June 30, 2015 included the following:

 

Assumptions

   Six Months Ended
June 30, 2015
 

Risk free interest rate

     1.53%-2.35

Expected volatility

     75%-80

Expected life

     6.02-10 years   

Expected dividend yield

     0

For employees, scientific founders, and directors, the expected life was calculated based on the simplified method as permitted by the SEC Staff Accounting Bulletin No. 110, Share-Based Payment . For other service providers, the expected life was calculated using the contractual term of the award. Management’s estimate of expected volatility was based on available information about the historical volatility of stocks of similar publicly-traded companies for a period matching the expected term assumption. The risk-free interest rate is based on a U.S. Treasury instrument whose term is consistent with the expected life of the stock options. In addition to the assumptions above, management made an estimate of expected forfeitures and is recognizing compensation costs only for those equity awards expected to vest. The weighted average grant date fair value of options granted for the six months ended June 30, 2015 was $49.93 per share.

For the three months ended June 30, 2015, the Company recognized $4.2 million in compensation expense related to stock options, of which $0.3 million was related to service providers other than our employees, scientific founders, and directors. Of the compensation costs related to stock options, for the three months ended June 30, 2015, $2.0 million was classified as research and development expense and $2.2 million was classified as general and administrative expense.

 

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For the six months ended June 30, 2015, the Company recognized $6.4 million in compensation expense related to stock options, of which $0.5 million was related to service providers other than our employees, scientific founders, and directors. Of the compensation costs related to stock options, for the six months ended June 30, 2015, $2.9 million was classified as research and development expense and $3.5 million was classified as general and administrative expense.

As of June 30, 2015, there was $66.1 million of total unrecognized compensation costs related to employees’ and directors’ stock options, which costs the Company expects to recognize over a remaining weighted average period of 3.29 years.

9. Accumulated Other Comprehensive Income (Loss)

The components of accumulated other comprehensive income (loss) and the adjustments to other comprehensive income (loss) are as follows (in thousands):

 

     Foreign currency
translation
adjustments
     Net unrealized
gains (losses)  on
available-for-sale
investments
     Accumulated other
comprehensive
income (loss)
 

Balance at December 31, 2014

   $ —         $ (90    $ (90

Other comprehensive income (loss)

     (125      (634      (759
  

 

 

    

 

 

    

 

 

 

Balance at June 30, 2015

   $ (125    $ (724    $ (849
  

 

 

    

 

 

    

 

 

 

10. Income Taxes

The Company recorded an income tax benefit of $1.6 million on a pre-tax loss of $132.5 million for the six months ended June 30, 2015. Of the $1.6 million total tax benefit, $0.5 million relates to the Juno GmbH net loss incurred in the period from May 11, 2015 to June 30, 2015, as the Company has determined that it is more-likely-than-not that it will realize the benefit of these losses. The remaining $1.1 million of income tax benefit relates to the release of valuation allowance on the U.S. deferred tax assets as a result of the deferred tax liabilities established for definite lived intangible assets from the acquisition of X-Body.

After consideration of the X-Body acquisition impact, the Company will continue to maintain a full valuation allowance on its net U.S. deferred tax assets. The assessment regarding whether a valuation allowance is required considers both positive and negative evidence when determining whether it is more-likely-than-not that deferred tax assets are recoverable. In making this assessment, significant weight is given to evidence that can be objectively verified. In its evaluation, the Company considered its cumulative loss in recent years and its forecasted losses in the near-term as significant negative evidence. The Company determined that the negative evidence outweighed the positive evidence and a full valuation allowance on its net deferred tax assets will be maintained. The Company will continue to assess the realizability of its deferred tax assets going forward and will adjust the valuation allowance as needed.

The Company applies judgment in the determination of the consolidated financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. As of June 30, 2015 and December 31, 2014, the Company had no material unrecognized tax benefits.

The Collaboration Agreement with Celgene became effective on July 31, 2015. The Company is currently in the process of evaluating the impact on its income tax accounts (including the valuation allowance) of the cash consideration received from Celgene.

11. Commitments and Contingencies

Leases

The Company has an operating lease for 23,191 square feet of office and laboratory space located in Seattle, Washington, which expires on June 27, 2017. The Company may terminate the lease agreement with 120 days’ notice after March 31, 2016. In November 2014, the Company entered into an operating lease for an additional 17,841 square feet of office and laboratory space located in the same building in Seattle, Washington as the Company’s existing leased space. The lease began in December 2014 and expires June 29, 2017. The Company may terminate the lease agreement with 120 days’ notice after March 31, 2016.

 

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In February 2015, the Company entered into a lease for an approximately 68,000 square foot manufacturing facility located in Bothell, Washington. The lease commenced in March 2015 and has an initial term of ten years. The Company has the right to terminate the lease effective as of any date after the second and on or before the seventh anniversary of the commencement of the lease term, with 12-months’ advance written notice and payment of an early termination fee equal to two years of rent and any unamortized leasing commissions paid by the landlord to any broker with respect to the initial term of the lease. The Company will also have two options to extend the term of the lease by five years each option, subject to a market-based rent escalation provision.

In April 2015, the Company entered into a lease agreement for approximately 90,000 square feet of office and laboratory space in a to-be-constructed building to be located in Seattle, Washington. The Company will also have three opportunities at certain points during the initial term to elect to expand the new premises to include additional space in the new building, subject to certain limitations. The anticipated commencement date of the lease is on or about February 1, 2017. The initial term of the lease continues for 84 months from the first day of the first full month following the commencement date.

The Company has an operating lease for 11,560 square feet of office and laboratory space located in Munich, Germany. The lease expires on December 31, 2016, with an option to extend the term for one approximately three-year period. The Company has an operating lease for 1,857 square feet of office and laboratory space located in Göttingen, Germany. The lease is cancellable by either party upon six weeks written notice.

The Company has an operating lease for 3,529 square feet of office and laboratory space located in Waltham, Massachusetts. The lease is cancellable by either party upon four months written notice.

The Company records rent expense on a straight-line basis over the effective term of the lease, including any free rent periods. Rent expense for the three months ended June 30, 2015 and 2014 was $0.5 million and $0.2 million, respectively. Rent expense for the six months ended June 30, 2015 and 2014 was $0.9 million and $0.4 million, respectively. The Company’s lease agreements also require payment of common area maintenance charges and other executory costs.

The following table summarizes the Company’s future minimum lease commitments as of June 30, 2015 (in thousands):

 

Year ending December 31:

  

2015

   $ 1,465   

2016

     2,992   

2017

     4,096   

2018

     5,964   

2019

     6,113   

Thereafter

     28,650   
  

 

 

 

Total minimum lease payments

   $ 49,280   
  

 

 

 

12. Related-Party Transactions

The Company has collaboration and license agreements with FHCRC and MSK, who are also common stockholders. See Note 3, Collaboration and License Agreements.

13. Subsequent Events

The Collaboration Agreement with Celgene became effective on July 31, 2015, in connection with which the Company received an upfront cash payment of $150.2 million. On August 4, 2015, the Initial Closing under the Purchase Agreement with Celgene occurred, and the Company sold 9,137,672 shares of the Company’s common stock to Celgene for an aggregate cash purchase price of approximately $849.8 million.

 

 

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion in conjunction with our condensed consolidated financial statements (unaudited) and related notes included elsewhere in this report. This Quarterly Report on Form 10-Q contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “aim,” “potential,” “continue,” “ongoing,” “goal,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements, include, but are not limited to, statements regarding: the success, cost and timing of our product development activities and clinical trials; our ability and the potential to successfully advance our technology platform to improve the safety and effectiveness of our existing product candidates; the potential for our identified research priorities to advance our CAR and TCR technologies; the potential of our collaboration with Celgene and the ability and willingness of Celgene to be our commercialization partner outside of North America; the ability and willingness of our third-party research institution collaborators to continue research and development activities relating to our product candidates; our ability to obtain orphan drug designation or breakthrough status for our CD19 product candidates and any other product candidates, or to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; our ability to commercialize our products in light of the intellectual property rights of others; our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates; our plans to research, develop, and commercialize our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; regulatory developments in the United States and foreign countries; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; our plans to develop our own manufacturing facilities; the success of competing therapies that are or may become available; our ability to attract and retain key scientific or management personnel; the accuracy of our estimates regarding expenses, success payments, future revenue, capital requirements, profitability, and needs for additional financing; fluctuations in the trading price of our common stock; the anticipated benefits of our recent litigation settlement; our plans regarding our corporate headquarters; and our use of the proceeds from our IPO. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under “Risk Factors” in this Quarterly Report on Form 10-Q. These forward-looking statements speak only as of the date hereof. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. Unless the context requires otherwise, in this Quarterly Report on Form 10-Q, the terms “Juno,” “Company,” “we,” “us” and “our” refer to Juno Therapeutics, Inc., a Delaware corporation, unless otherwise noted.

Overview

We are building a fully-integrated biopharmaceutical company focused on developing cell-based cancer immunotherapies based on our CAR and high-affinity TCR technologies to genetically engineer T cells to recognize and kill cancer cells.

We have shown compelling evidence of tumor shrinkage in clinical trials with multiple cell-based product candidates to address refractory B cell lymphomas and leukemias. Before the end of 2015, we plan to have begun a Phase II trial that could support accelerated U.S. regulatory approval in relapsed/refractory B cell acute lymphoblastic leukemia (“ALL”), a Phase I trial in relapsed/refractory B cell non-Hodgkin lymphoma (“NHL”), and Phase I trials for at least five additional product candidates that target different cancer-associated proteins in hematological and solid organ cancers. Patient enrollment has begun in three of these Phase I trials as of the date of this report.

We have assembled a talented group of scientists, engineers, clinicians, directors, and other advisers who consolidate and develop technologies and intellectual property from some of the world’s leading research institutions, including FHCRC, MSK, SCRI, and the National Cancer Institute.

 

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We have agreed to make success payments to each of FHCRC and MSK pursuant to the terms of our collaboration agreements with each of those entities. For additional information regarding these success payments, see the section captioned “Critical Accounting Polices and Significant Judgments and Estimates— Success Payments” in Part II—Item 7—“Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2014 Annual Report.

We are devoting significant resources to process development and manufacturing in order to optimize the safety and efficacy of our product candidates, as well as our cost of goods and time to market. To date, we have leveraged our relationships with our founding institutions for manufacturing for our clinical trials; however, we are in the process of both establishing our own manufacturing facility and bringing a contract manufacturing organization (“CMO”) on-line to support current Good Manufacturing Practices (“cGMP”) manufacturing to meet the expected demand needs of clinical supply and commercial launch.

Our goal is to carefully manage our fixed cost structure, maximize optionality, and drive long-term cost of goods as low as possible. The use of one or more CMOs with established cGMP infrastructure will increase the speed with which capacity can be brought on-line. We plan to complement the use of one or more CMOs by establishing our own cGMP manufacturing facility to be brought on-line after the first CMO. As described in Part I—Item 2—“Properties” of our 2014 Annual Report, we have entered into a ten-year lease for a facility that we plan to remodel to support our clinical and commercial manufacturing activities. We believe that operating our own manufacturing facility will provide us with enhanced control of material supply for both clinical trials and the commercial market, will enable the more rapid implementation of process changes, and will allow for better long-term margins.

As of June 30, 2015, the only revenue we had generated is from an upfront license payment in connection with the Penn/Novartis Sublicense Agreement entered into in April 2015 and limited grant and product revenue from our newly acquired subsidiary in Germany. We will also recognize revenue in the third quarter of 2015 related to our entry into the Collaboration Agreement with Celgene. In the future, we may generate revenue from product sales, collaboration agreements, strategic alliances and licensing arrangements, or a combination of these. We expect that any revenue we generate will fluctuate from quarter to quarter and year to year as a result of the timing and amount of license fees, milestones, reimbursement of costs incurred and other payments and product sales, to the extent any are successfully commercialized. If we fail to complete the development of our product candidates in a timely manner or obtain regulatory approval of them, our ability to generate future revenue, and our results of operations and financial position, would be materially adversely affected.

As of June 30, 2015, we had cash, cash equivalents, and marketable securities of $313.4 million compared with $474.1 million as of December 31, 2014. Cash used in operations for the six months ended June 30, 2015 was $70.2 million compared with cash used in operations of $23.4 million for the six months ended June 30, 2014. Included in cash used in operations in the six months ended June 30, 2015 is $30.8 million in costs to acquire technology in the Editas and Fate Therapeutics collaborations. Included in net cash used in investing activities is $77.7 million of net cash used to acquire Stage and X-Body, offset by cash acquired, and $7.2 million used to acquire the investment in Fate Therapeutics.

Recent Developments

During the second quarter of 2015, we had a number of corporate developments:

 

    In April 2015, we entered into a lease agreement for approximately 90,000 square feet of office and laboratory space in a to-be-constructed building to be located in Seattle, Washington, with an estimated commencement date of February 1, 2017. We will also have opportunities to expand the new premises to include additional space in the new building. See Note 11, Commitments and Contingencies, in the notes to the condensed consolidated financial statements included elsewhere in this report for additional information.

 

    In April 2015, we and St. Jude agreed to settle the Penn litigation with Penn and Novartis. In connection with such settlement, we entered into the Penn/Novartis Sublicense Agreement with Penn and an affiliate of Novartis. As described in more detail in Note 3, Collaboration and License Agreements, in the notes to the condensed consolidated financial statements included elsewhere in this report, Novartis paid us an initial license fee of $12.3 million, and will be required to pay us royalties on the U.S. net sales of products and services related to the disputed contract and patent claims, a percentage of the royalties Novartis pays to Penn for global net sales of those products, and milestone payments.

 

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    In April 2015, we entered into a clinical study collaboration agreement with MedImmune, Inc. (“MedImmune”) to conduct combination clinical trials in immuno-oncology with one of our investigational CD19-directed CAR product candidates and MedImmune’s investigational programmed cell death ligand 1 (“PD-L1”) immune checkpoint inhibitor, MEDI4736. Under the initial development plan, both companies will explore the safety, tolerability and preliminary efficacy of the combination therapy as a potential treatment for patients with NHL. MedImmune and Juno will jointly co-fund the initial Phase Ib trial, which is expected to begin later in 2015. The companies will also explore the combination of MEDI4736 with a next-generation, Juno-developed fully human CD19-directed CAR product candidate.

 

    In May 2015, we entered into a collaboration and license agreement with Fate Therapeutics to identify and utilize small molecules to modulate our genetically-engineered T cell product candidates to improve their therapeutic potential for cancer patients. As described in Note 3, Collaboration and License Agreements, in the notes to the condensed consolidated financial statements included elsewhere in this report, we made an upfront payment, including the purchase of common stock of Fate Therapeutics, we will be required to provide research funding to Fate Therapeutics, and we may be obligated to make milestone and royalty payments on Juno products that result from such collaboration.

 

    In May 2015, we entered into a collaboration and license agreement with Editas, to pursue research programs utilizing Editas’ genome editing technologies with our CAR and TCR technologies. As described in Note 3, Collaboration and License Agreements, in the notes to the condensed consolidated financial statements included elsewhere in this report, we made an upfront payment to Editas, will be required to provide research funding to Editas, and may be obligated to make milestone and royalty payments on Juno products that result from such collaboration.

 

    In May 2015, we acquired all the remaining ownership interests in Stage not already held by us. See Note 2, Acquisitions, in the notes to the condensed consolidated financial statements included elsewhere in this report for additional information. The acquisition furthers our strategy of being a world leader in process development and the manufacturing of cellular therapies. The acquisition provides Juno access to transformative cell selection and activation capabilities, next generation manufacturing automation technologies, enhanced control of its supply chain, and lower expected long-term cost of goods. We are operating the acquired company as a wholly-owned German subsidiary under the name Juno Therapeutics GmbH and the results of Juno GmbH have been consolidated with our results since the date of the acquisition.

 

    In June 2015, we acquired X-Body. See Note 2, Acquisitions, in the notes to the condensed consolidated financial statements included elsewhere in this report for additional information. The acquisition furthers our strategy of investing in technologies that augment our capabilities to create best-in-class engineered T cells against a broad array of cancer targets. The acquisition brings in-house an innovative discovery platform that interrogates the human antibody repertoire, rapidly selecting fully human antibodies with desired characteristics, even against difficult targets. As a result of the acquisition, X-Body has become a wholly owned subsidiary and the results of X-Body have been consolidated with our results since the date of the acquisition.

 

    In June 2015, we entered into the Collaboration Agreement with Celgene pursuant to which we and Celgene agreed to collaborate on researching, developing, and commercializing novel cellular therapy product candidates and other immuno-oncology and immunology therapeutics, including, in particular, CAR and TCR product candidates. We also entered into the Purchase Agreement with Celgene for the sale of shares of our common stock to Celgene at an initial closing and multiple potential future closings. See Note 3, Collaboration and License Agreements, for additional information about this broad-reaching collaboration. On July 31, 2015, the Collaboration Agreement became effective, in connection with which we received an upfront cash payment of $150.2 million from Celgene. On August 4, 2015, we sold 9,137,672 shares of Juno’s common stock to Celgene for an aggregate cash purchase price of approximately $849.8 million.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 

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Goodwill and Intangible Assets

Goodwill represents the excess of the purchase price over the net amount of identifiable assets acquired and liabilities assumed in a business combination measured at fair value. We evaluate goodwill for impairment annually during the fourth quarter and upon the occurrence of triggering events or substantive changes in circumstances that could indicate a potential impairment by assessing qualitative factors or performing a quantitative analysis in determining whether it is more likely than not that the fair value of net asset are below their carrying amounts.

Intangible assets acquired in a business combination are recognized separately from goodwill and are initially recognized at their fair value at the acquisition date (which is regarded as their cost). Intangible assets related to in-process research and development (“IPR&D”) are treated as indefinite-lived intangible assets and not amortized until certain regulatory approval in specified markets is obtained in the case of X-Body, and in the case of Stage, when the acquired reagents or automation technology is accepted by the FDA as part of an IND, subject to management judgment. At that time, we will determine the useful life of the asset, reclassify the asset out of IPR&D and begin amortization. Intangible assets are reviewed for impairment at least annually or if indicators of potential impairment exist. There were no impairments as of June 30, 2015.

Contingent Consideration from Business Combinations

At and subsequent to the acquisition date of a business combination, contingent consideration obligations are remeasured to fair value at each balance sheet date with changes in fair value recognized in research and development expense in the condensed consolidated statements of operations. Changes in fair values reflect changes to our assumptions regarding probabilities of successful achievement of related milestones, the timing in which the milestones are expected to be achieved, and the discount rate used to estimate the fair value of the obligation, as well as the foreign currency impact of the contingent consideration for the Stage acquisition as it is denominated in Euro.

Build-to-Suit Lease Accounting

In February 2015, we entered into the Bothell Lease for a manufacturing facility, which lease commenced in March 2015. We are responsible for the leasehold improvements required to remodel the facility and we bear the majority of the construction risk. ASC 840-40, Leases – Sale-Leaseback Transactions (Subsection 05-5) , requires us to be considered the owner of the building solely for accounting purposes, even though we are not the legal owner. As a result, we recorded an asset and build-to-suit lease obligation on our balance sheet as of June 30, 2015 equal to the fair value of the building.

Once construction is complete, we will consider the requirements for sale-leaseback accounting treatment, including evaluating whether all risks of ownership have transferred back to the landlord, as evidenced by a lack of continuing involvement in the leased property. If the arrangement does not qualify for sale-leaseback accounting treatment, the building asset remains on our balance sheet at its historical cost, and such asset is depreciated over its estimated useful life. We bifurcate our lease payments into a portion allocated to the building and a portion allocated to the parcel of land on which the building has been built. The portion of the lease payments allocated to the land is treated for accounting purposes as operating lease payments, and therefore is recorded as rent expense in the statements of operations. The portion of the lease payments allocated to the building is further bifurcated into a portion allocated to interest expense and a portion allocated to reduce the build-to-suit lease obligation.

The interest rate used for the build-to-suit lease obligation represents our estimated incremental borrowing rate, adjusted to reduce any built in loss.

There have been no other materials changes to our critical accounting policies from those described in Part II—Item 7— “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2014 Annual Report.

 

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Components of Operating Results

Research and Development

Research and development expenses represent costs incurred by us for the discovery, development, and manufacture of our product candidates and include: costs to acquire technology complimentary to our own, license fees to acquire technology, external research and development expenses incurred under arrangements with third parties, such as contract research organizations, CMOs, academic and non- profit institutions and consultants, salaries and personnel-related costs, including non-cash stock-based compensation, the estimated fair value of the liability attributable to the elapsed service period as of the balance sheet date associated with our success payments to FHCRC and MSK, changes in the estimated fair value of our contingent consideration liabilities, and other expenses, which include direct and allocated expenses for laboratory, facilities, and other costs.

We use our employee and infrastructure resources across multiple research and development programs directed toward developing our cell-based platform and for identifying and developing product candidates. We manage certain activities such as contract research, clinical trial operations, and manufacture of product candidates through our partner institutions or other third-party vendors. We track our significant external costs by product candidate. Due to the number of ongoing projects and our ability to use resources across several projects, we do not record or maintain information regarding the indirect operating costs incurred for our research and development programs on a program-specific basis.

Research and development activities account for a significant portion of our operating expenses. Excluding amounts attributable to changes in the estimated fair value of the success payment liability and upfront fees to acquire technology, we expect our research and development expenses to increase over the next several years as we implement our business strategy which includes conducting existing and new clinical trials, manufacturing clinical trial and preclinical study materials, expanding our research and development and process development efforts, seeking regulatory approvals for our product candidates that successfully complete clinical trials, and costs associated with hiring additional personnel to support our research and development efforts. Research and development expense related to our success payments is unpredictable and may vary significantly from quarter to quarter and year to year due to changes in our stock price or other assumptions used in the calculation. A significant decline in the estimated value of the success payment liability may result in negative expense and possibly net income during the period. In addition, we expect to incur expense for acquisition of technology in the future, but the timing and amount of those expenses cannot be estimated with reliability and may also fluctuate from quarter to quarter and year to year.

General and Administrative

General and administrative expenses consist of salaries and personnel-related costs, including non-cash stock-based compensation, for our personnel in executive, legal, finance and accounting, and other administrative functions, non-litigation legal costs, as well as fees paid for accounting and tax services, consulting fees and facility costs not otherwise included in research and development expenses. Non-litigation legal costs include general corporate legal fees and patent costs.

We anticipate that our general and administrative expenses will increase in the future to support our continued research and development activities, potential commercialization of our product candidates, and the increased costs of operating as a public company. These increases will likely include costs related to outside consultants, attorneys, and accountants, among other expenses.

Litigation

Litigation expense includes legal expense we have directly incurred with respect to the Penn litigation, as well as expenses we are required to reimburse to St. Jude with respect to such litigation. In April 2015 the Penn litigation was settled, in connection with which Novartis paid us an initial license fee of $12.3 million. In connection with the settlement, we incurred litigation expense of $5.3 million associated with the reimbursement of litigation expenses to St. Jude. See Note 3, Collaboration and License Agreements, in the notes to the condensed consolidated financial statements included elsewhere in this report.

 

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Results of Operations

Comparison of the three and six months ended June 30, 2015 and June 30, 2014

The following table summarizes our results of operations for the three and six months ended June 30, 2015 and 2014 (in thousands):

 

     Three Months Ended June 30,      Six Months Ended June 30,  
     2015      2014      2015      2014  

Revenue

   $ 12,461       $ —         $ 12,461       $ —     

Operating expenses:

           

Research and development

     60,235         6,479         118,034         9,418   

General and administrative

     14,857         4,568         21,527         7,959   

Litigation

     5,334         1,633         6,025         3,623   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total operating expenses

     80,426         12,680         145,586         21,000   
  

 

 

    

 

 

    

 

 

    

 

 

 

Loss from operations

     (67,965      (12,680      (133,125      (21,000

Interest income, net

     158         —           353      

Other income (expenses)

     233         (10,089      233         (10,718
  

 

 

    

 

 

    

 

 

    

 

 

 

Loss before income taxes

     (67,574      (22,769      (132,539      (31,718

Benefit from income taxes

     1,616         —           1,616         —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Net loss

   $ (65,958    $ (22,769    $ (130,923    $ (31,718
  

 

 

    

 

 

    

 

 

    

 

 

 

Revenue

Revenue was $12.5 million in the three and six months ended June 30, 2015 which consisted of $12.3 million received in connection to the Novartis sublicense agreement and $0.2 million related to grant and product revenue earned by Juno GmbH, our German subsidiary.

Operating Expenses

Research and Development Expenses . Research and development expenses were $60.2 million for the three months ended June 30, 2015, compared to $6.5 million for the three months ended June 30, 2014, and $118.0 million for the six months ended June 30, 2015, compared to $9.4 million for the six months ended June 30, 2014. The increase of $53.7 million in the three months ended June 30, 2015 was primarily due to increased expenses of:

 

    $30.8 million in costs to acquire technology;

 

    $12.9 million of costs to expand the company’s overall research and development capabilities and advance programs at our founding institutions including personnel costs, manufacturing costs in support of our clinical trials, clinical and research costs under our collaboration agreements and in support of our company-sponsored clinical trials, lab supplies, consulting, and facilities and allocated overhead costs;

 

    $3.8 million of non-cash stock-based compensation, of which $1.7 million is related to a former co-founding director who became a consultant upon his departure from the board of directors; and

 

    $3.8 million associated with the portion of the estimated success payment liability to FHCRC and MSK attributable to the elapsed service period and driven by the increase in our stock price compared to the prior year.

The increase of $108.6 million in the six months ended June 30, 2015 was primarily due to increased expenses of:

 

    $42.5 million associated with the portion of the estimated success payment liability to FHCRC and MSK attributable to the elapsed service period and driven by the increase in our stock price compared to the prior year;

 

    $30.8 million in costs to acquire technology;

 

    $24.6 million of costs to expand the company’s overall research and development capabilities and advance programs at our founding institutions including personnel costs, manufacturing costs in support of our clinical trials, clinical and research costs under our collaboration agreements and in support of our company-sponsored clinical trials, lab supplies, consulting, and facilities and allocated overhead costs; and

 

    $7.3 million of non-cash stock-based compensation, of which $3.6 million is related to a former co-founding director who became a consultant upon his departure from the board of directors.

 

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Our research and development expenses by project were as follows for the three and six months ended June 30, 2015 and 2014 (in thousands):

 

     Three Months Ended June 30,      Six Months Ended June 30,  
     2015      2014      2015      2014  

Project-specific external costs:

           

JCAR015

   $ 2,667       $ 644       $ 4,833       $ 929   

JCAR014

     1,283         881         2,021         1,275   

JCAR017

     847         —           1,605         —     

Platform development

     5         130         741         255   

CD19 general

     315         286         1,301         517   

Early development

     2,706         1,705         4,582         1,931   

Success payment expense related to FHCRC collaboration agreement

     2,764         143         29,935         265   

Success payment expense related to MSK collaboration agreement

     1,198         66         12,937         121   

Upfront costs to acquire technology

     30,800         —           30,800         —     

Unallocated internal and external research and development costs

     17,650         2,624         29,279         4,125   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total research and development expenses

   $ 60,235       $ 6,479       $ 118,034       $ 9,418   
  

 

 

    

 

 

    

 

 

    

 

 

 

General and Administrative Expenses. General and administrative expenses were $14.9 million for the three months ended June 30, 2015 compared to $4.6 million for the three months ended June 30, 2014, and $21.5 million for the six months ended June 30, 2015, compared to $8.0 million for the six months ended June 30, 2014. The increase of $10.3 million in the three months ended June 30, 2015 was primarily due to transaction costs associated with the Stage and X-Body acquisitions of $4.2 million, higher personnel expenses of $2.7 million largely related to increased headcount, $1.7 million of which was non-cash stock-based compensation, and an increase in patent and corporate legal fees of $2.5 million primarily due to business development activities. The increase of $13.5 million in the six months ended June 30, 2015 was primarily due to higher personnel expenses of $4.6 million largely related to increased headcount, $3.0 million of which was non-cash stock-based compensation, costs associated with the Stage and X-Body acquisitions of $4.3 million, and an increase in patent and corporate legal fees of $3.0 million primarily due to business development activities.

Litigation Expense. Litigation expense was $5.3 million for the three months ended June 30, 2015 compared to $1.6 million for the three months ended June 30, 2014, and $6.0 million for the six months ended June 30, 2015 compared to $3.6 million for the six months ended June 30, 2014. Litigation costs in both periods consisted of costs we incurred directly in connection with the Penn litigation and costs we were required to reimburse to St. Jude in connection with such litigation. In April 2015 the Penn litigation was settled. See Note 3, Collaboration and License Agreements, to the condensed consolidated financial statements included elsewhere in this report.

Interest Income, Net. Interest income, net for the three and six months ended June 30, 2015 of $0.2 million and $0.4 million, respectively, consisted of interest income earned on our marketable securities offset by interest expense associated with the accounting for the build-to-suit lease of our manufacturing facility.

Other Income (Expense). Other income was $0.2 million for both the three and six months ended June 30, 2015 which consisted of the gain on our original investment in Stage recorded in connection with the acquisition of Stage in May 2015. Other expense was $10.1 million and $10.7 million for the three and six months ended June 30, 2014, respectively, which consisted of changes in the fair value of our Series A convertible preferred stock option, which was exercised during 2014.

Benefit from Income Taxes. Benefit from income taxes was $1.6 million for both the three and six months ended June 30, 2015. The Company recorded an income tax benefit of $1.6 million on a pre-tax loss of $132.5 million for 2015. No income tax benefit is recognized for the U.S. pre-tax loss generated during the quarter as it was subject to a full valuation allowance. Of the $1.6 million income tax benefit, $0.5 million of the income tax benefit relates to Juno GmbH net loss incurred in the period from May 11, 2015 to June 30, 2015, and the Company has determined that it is more-likely-than-not that it will realize the benefit of these losses. The remaining $1.1 million of income tax benefit relates to the release of valuation allowance on the U.S. deferred tax assets as a result of the acquisition of X-Body. In the future we may be required to pay tax on revenue generated from the Celgene collaboration.

 

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Liquidity and Capital Resources

Sources of Liquidity

To date we have raised an aggregate of approximately $618 million in gross proceeds, through our IPO and private placements of our convertible preferred stock which we have used to fund our operations. As of June 30, 2015, we had $313.4 million in cash, cash equivalents and marketable securities.

See “Liquidity and Capital Resources—Plan of Operation and Future Funding Requirements” in Part II—Item 7—“Management’s Discussion and Analysis of Financial Condition and Results of Operations” of the 2014 Annual Report for a description of potential future funding requirements. As a result of our entry into the collaboration with Celgene and our initial sale of stock to Celgene, we received $1.0 billion in cash from Celgene in August 2015. This funding decreases our need for additional near term funding, although we may still need to raise additional capital in the future.

We believe that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operations for at least the next 12 months.

Cash Flows

The following table summarizes our cash flows for the six months ended June 30, 2015 and 2014 (in thousands):

 

     Six Months Ended June 30,  
     2015      2014  

Net cash (used in) provided by:

     

Operating activities

   $ (70,158    $ (23,365

Investing activities

     (244,883      (4,170

Financing activities

     (1,397      62,614   

Effect of exchange rate changes on cash and cash equivalents

     (12      —     
  

 

 

    

 

 

 

Net (decrease) increase in cash and cash equivalents

   $ (316,450    $ 35,079   
  

 

 

    

 

 

 

Operating Activities

The increase in cash used in operating activities for the six months ended June 30, 2015 of $46.8 million compared to the six months ended June 30, 2014 was primarily due to the $30.8 million in upfront cash payments made in connection with the Editas and Fate collaborations as well as the overall growth of the business which included expanding the workforce, manufacturing in support of our clinical trials, and clinical and research costs. This was offset by the cash received in connection with the Penn/Novartis Sublicense Agreement of $12.3 million.

Investing Activities

The increase in cash used in investing activities for the six months ended June 30, 2015 of $240.7 million compared to the six months ended June 30, 2014 was primarily due to net purchases of marketable securities of $150.9 million in 2015, cash paid, net of cash acquired, to acquire Stage and X-Body of $77.7 million, an investment in Fate of $7.2 million, and an increase in property and equipment purchases of $8.4 million, offset by the investment in Stage of $3.5 million in 2014.

Financing Activities

Net cash used in financing activities for the six months ended June 30, 2015 consisted primarily of cash payments for costs associated with our IPO and proceeds from the exercise of stock options. Net cash provided by financing activities for the six months ended June 30, 2014 consisted of cash proceed from the issuance of our convertible preferred stock.

 

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Off-Balance Sheet Arrangements

As of June 30, 2015, we did not have any off-balance sheet arrangements or any holdings in variable interest entities.

JOBS Act

As an “emerging growth company,” the Jumpstart our Business Startups Act allows us to delay adoption of new or revised accounting standards applicable to public companies until such standards are made applicable to private companies. However, we have irrevocably elected not to avail ourselves of this extended transition period for complying with new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are exposed to market risks in the ordinary course of our business, primarily related to interest rate sensitivities and the volatility of our stock price.

Interest Rate Sensitivity

As of June 30, 2015, we had $273.9 million in marketable securities, largely composed of investment grade short- to intermediate-term fixed income securities. The primary objective of our investment activities is to preserve capital to fund our operations. We also seek to maximize income from our investments without assuming significant risk. To achieve our objectives, we maintain a portfolio of investments in a variety of securities of high credit quality.

Our marketable securities are subject to interest rate risk and could fall in value if market interest rates increase. A hypothetical 10% change in interest rates during any of the periods presented would not have had a material impact on our financial statements.

Stock Price Sensitivity

We agreed to make success payments to FHCRC and MSK based on increases in the per share fair market value of our common stock during the term of the agreements payable in cash or publicly-traded equity at our discretion. A small change in our stock price may have a relatively large change in the estimated fair value of the success payment liability and associated expense.

As of June 30, 2015, the estimated fair value of the success payment obligations was approximately $211.4 million. We recognized research and development expense of $4.0 million and $42.9 million in the three and six months ended June 30, 2015, respectively, related to the success payment obligations. The expense recorded for the three and six months ended June 30, 2015 represents the change in the success payment liability during such period and reflects an additional three months of accrued expense. The success payment liabilities on the balance sheet as of June 30, 2015 were $127.8 million.

The assumptions used to calculate the fair value of the success payments are subject to a significant amount of judgment including the expected volatility, estimated term, and estimated number and timing of valuation measurement dates. A small change in the assumptions may have a relatively large change in the estimated valuation and associated liability and expense. For example, keeping all other variables constant, a hypothetical 10% increase in the stock price at June 30, 2015 from $53.33 per share to $58.66 per share would have increased the expense recorded in the three months ended June 30, 2015 associated with the success payment liability by $15.5 million. A hypothetical 10% decrease in the stock price from $53.33 per share to $48.00 per share would have decreased the expense recorded in the three months ended June 30, 2015 associated with the success payment liability by $15.7 million, resulting in a gain of $11.7 million. Further, keeping all other variables constant, a hypothetical 35% increase in the stock price at June 30, 2015 from $53.33 per share to $72.00 per share would have increased the expense recorded in the three months ended June 30, 2015 associated with the success payment liability by $147.2 million. A hypothetical 35% decrease in the stock price from $53.33 per share to $34.66 per share would have decreased the expense recorded in the three months ended June 30, 2015 associated with the success payment liability by $56.3 million, resulting in a gain of $52.3 million.

 

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ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

As required by Rule 13a-15(b) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), our management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of June 30, 2015. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2015, our Chief Executive Officer and Chief Financial Officer have concluded that, as of June 30, 2015, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting during the quarter ended June 30, 2015, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

From time to time, we may become involved in litigation relating to claims arising from the ordinary course of business. Our management believes that there are currently no claims or actions pending against us, the ultimate disposition of which could have a material adverse effect on our results of operations, financial condition or cash flows.

On April 4, 2015, Juno and St. Jude agreed to settle the Penn litigation with Penn and Novartis, and the case was dismissed on April 7, 2015. In connection with such settlement, we entered into the Penn/Novartis Sublicense Agreement and an amendment to the St. Jude License Agreement. See Note 3, Collaboration and License Agreements, in the notes to the condensed consolidated financial statements included elsewhere in this report for more information about the settlement and these agreements.

 

ITEM 1A. RISK FACTORS

The following section includes the most significant factors that may adversely affect our business and operations. You should carefully consider the risks and uncertainties described below and all information contained in this report, including our financial statements and the related notes and Part I—Item 2—“Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding 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. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

Risks Related to Our Business and Industry

We are a clinical-stage company and have a very limited operating history, which may make it difficult to evaluate our current business and predict our future performance.

We are a clinical-stage biopharmaceutical company that was recently formed in August 2013. We have no cell-therapy products approved for commercial sale and as of June 30, 2015 had not generated any revenue from such products. We are focused on developing products that use human cells as therapeutic entities and, although there have been significant advances in cell- based immunotherapy, our T cell technologies are new and largely unproven. Our limited operating history, particularly in light of the rapidly evolving cancer immunotherapy field, may make it difficult to evaluate our current business and predict our future performance. Our very short history as an operating company makes any assessment of our future success or viability subject to significant uncertainty. We will encounter risks and difficulties frequently experienced by early-stage companies in rapidly evolving fields. If we do not address these risks successfully, our business will suffer.

We have incurred net losses in each period since our inception and anticipate that we will continue to incur net losses in the future.

We are not profitable and have incurred losses in each period since our inception. For the three and six months ended June 30, 2015, we reported a net loss of $66.0 million and $130.9 million, respectively. For the year ended December 31, 2014, we reported a net loss of $243.4 million. As of June 30, 2015, we had an accumulated deficit of $477.2 million, of which $127.8 million represents the portion of the estimated success payment liability attributable to the elapsed service period; $51.1 million of deemed dividends on our convertible preferred stock; and $10.7 million of expense associated with our convertible preferred stock options. We expect these losses to increase as we continue to incur significant research and development and other expenses related to our ongoing operations, seek regulatory approvals for our product candidates, scale-up manufacturing capabilities and hire additional personnel to support the development of our product candidates and to enhance our operational, financial and information management systems.

A critical aspect of our strategy is to invest significantly in our technology platform to improve the efficacy and safety of our product candidates. Even if we succeed in commercializing one or more of these product candidates, we will continue to incur losses for the foreseeable future relating to our substantial research and development expenditures to develop our technologies. 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

 

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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. Further, the net losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a period to period comparison of our results of operations may not be a good indication of our future performance.

We expect to continue to incur significant losses for the foreseeable future. We expect these losses and our cash utilization to increase in the near term as we continue to conduct clinical trials, file additional Investigational New Drug (“IND”) filings for additional product candidates, and conduct research and development of our other product candidates.

We are collaborating with Celgene pursuant to a collaboration agreement, under which we and Celgene will research, develop and commercialize novel cellular therapy product candidates and other immuno-oncology and immunology therapeutics, including, in particular, CAR and TCR product candidates. Contingent upon the payment of certain upfront payments, Celgene may exercise options to acquire exclusive licenses to certain therapeutics we develop and each party may exercise certain options to co-develop and co-commercialize product candidates developed, or acquired or in-licensed, by the other party. If Celgene does not exercise its options, or if our collaboration with Celgene terminates, we will be responsible for funding further development of the relevant product candidates, which would cause our expenses to increase, unless we enter into another collaboration for such product candidates, which may not be possible within and acceptable timeframe, or on suitable terms. Similarly, our expenses would increase if we exercise an option to co-develop and co-commercialize any product candidate developed, or in-licensed or acquired, by Celgene. If any of these were to occur, our losses could increase.

We have never generated any revenue from sales of cell-therapy products and our ability to generate revenue from cell-therapy product sales and become profitable depends significantly on our success in a number of factors.

We have no products approved for commercial sale, have not generated any revenue from product sales, and do not anticipate generating any revenue from product sales until some time after we have received regulatory approval for the commercial sale of a product candidate. Our ability to generate revenue and achieve profitability depends significantly on our success in many factors, including:

 

  completing research regarding, and nonclinical and clinical development of, our product candidates;

 

  obtaining regulatory approvals and marketing authorizations for product candidates for which we complete clinical studies;

 

  developing a sustainable and scalable manufacturing process for our product candidates, including establishing and maintaining commercially viable supply relationships with third parties and establishing our own manufacturing capabilities and infrastructure;

 

  launching and commercializing product candidates for which we obtain regulatory approvals and marketing authorizations, either directly or with a collaborator or distributor;

 

  obtaining market acceptance of our product candidates as viable treatment options, and obtaining adequate coverage, reimbursement, and pricing by third-party payors and government authorities;

 

  addressing any competing technological and market developments;

 

  Celgene exercising any of its options under our collaboration agreement with Celgene, and Celgene’s efforts to further develop and commercialize the associated product candidates;

 

  identifying, assessing, acquiring and/or developing new product candidates;

 

  negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter;

 

  maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets, and know-how; and

 

  attracting, hiring, and retaining qualified personnel.

 

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Even if one or more of the product candidates that we develop is approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Our expenses could increase beyond expectations if we are required by the U.S. Food & Drug Administration (“FDA”), or other regulatory agencies, domestic or foreign, to change our manufacturing processes or assays, or to perform clinical, nonclinical, or other types of studies in addition to those that we currently anticipate. If we are successful in obtaining regulatory approvals to market one or more of our product candidates, our revenue will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the accepted price for the product, the ability to get reimbursement at any price, and whether we own the commercial rights for that territory. If the number of our addressable disease patients is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we expect, or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products, even if approved. If we are not able to generate revenue from the sale of any approved products, we may never become profitable.

Our technology platform, including our CAR and high-affinity TCR technologies are new approaches to cancer treatment that present significant challenges.

We have concentrated our research and development efforts on T cell immunotherapy technology, and our future success is highly dependent on the successful development of T cell immunotherapies in general and our CAR and TCR technologies and product candidates in particular. Our approach to cancer treatment aims to alter T cells ex vivo through genetic modification using certain viruses designed to reengineer the T cells to recognize specific proteins on the surface or inside cancer cells. Because this is a new approach to cancer immunotherapy and cancer treatment generally, developing and commercializing our product candidates subjects us to a number of challenges, including:

 

  obtaining regulatory approval from the FDA and other regulatory authorities that have very limited experience with the commercial development of genetically modified T cell therapies for cancer;

 

  developing and deploying consistent and reliable processes for engineering a patient’s T cells ex vivo and infusing the engineered T cells back into the patient;

 

  conditioning patients with chemotherapy in conjunction with delivering each of our products, which may increase the risk of adverse side effects of our products;

 

  educating medical personnel regarding the potential side effect profile of each of our products, such as the potential adverse side effects related to cytokine release;

 

  developing processes for the safe administration of these products, including long-term follow-up for all patients who receive our product candidates;

 

  sourcing clinical and, if approved, commercial supplies for the materials used to manufacture and process our product candidates;

 

  developing a manufacturing process and distribution network with a cost of goods that allows for an attractive return on investment;

 

  establishing sales and marketing capabilities after obtaining any regulatory approval to gain market acceptance, and obtaining adequate coverage, reimbursement, and pricing by third-party payors and government authorities; and

 

  developing therapies for types of cancers beyond those addressed by our current product candidates.

We cannot be sure that our T cell immunotherapy technologies will yield satisfactory products that are safe and effective, scalable, or profitable.

 

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Additionally, because our technology involves the genetic modification of patient cells ex vivo using a virus, we are subject to many of the challenges and risks that gene therapies face, including:

 

  Regulatory requirements governing gene and cell therapy products have changed frequently and may continue to change in the future. To date, no products that involve the genetic modification of patient cells have been approved in the United States and only one has been approved in the European Union (“EU”).

 

  Genetically modified products in the event of improper insertion of a gene sequence into a patient’s chromosome could lead to lymphoma, leukemia or other cancers, or other aberrantly functioning cells.

 

  Although our viral vectors are not able to replicate, there is a risk with the use of retroviral or lentiviral vectors that they could lead to new or reactivated pathogenic strains of virus or other infectious diseases.

 

  The FDA recommends a 15 year follow-up observation period for all patients who receive treatment using gene therapies, and we may need to adopt such an observation period for our product candidates.

 

  Clinical trials using genetically modified cells conducted at institutions that receive funding for recombinant DNA research from the NIH, are subject to review by the Recombinant DNA Advisory Committee (“RAC”). Although the FDA decides whether individual protocols may proceed, the RAC review process can impede the initiation of a clinical trial, even if the FDA has reviewed the study and approved its initiation.

Moreover, public perception of therapy safety issues, including adoption of new therapeutics or novel approaches to treatment, may adversely influence the willingness of subjects to participate in clinical trials, or if approved, of physicians to subscribe to the novel treatment mechanics. Physicians, hospitals and third-party payors often are slow to adopt new products, technologies and treatment practices that require additional upfront costs and training. Physicians may not be willing to undergo training to adopt this novel and personalized therapy, may decide the therapy is too complex to adopt without appropriate training and may choose not to administer the therapy. Based on these and other factors, hospitals and payors may decide that the benefits of this new therapy do not or will not outweigh its costs.

Our near term ability to generate product revenue is dependent on the success of one or more of our CD19 product candidates, each of which are at an early-stage of development and will require significant additional clinical testing before we can seek regulatory approval and begin commercial sales.

Our near term ability to generate product revenue is highly dependent on our ability to obtain regulatory approval of and successfully commercialize one or more of our CD19 product candidates. Our most advanced product candidates, JCAR015, JCAR017, and JCAR014, are in the early stages of development, have been tested in a relatively small number of patients, and will require additional clinical and nonclinical development, regulatory review and approval in each jurisdiction in which we intend to market the products, substantial investment, access to sufficient commercial manufacturing capacity, and significant marketing efforts before we can generate any revenue from product sales. Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical studies to demonstrate the safety, purity, and potency of the product candidates in humans. We cannot be certain that any of our product candidates will be successful in clinical studies and they may not receive regulatory approval even if they are successful in clinical studies.

In addition, because JCAR015, JCAR017, and JCAR014 are our most advanced product candidates, and because our other product candidates are based on similar technology, if JCAR015, JCAR017, or JCAR014 encounter safety or efficacy problems, developmental delays, regulatory issues, reagent supply issues, or other problems, our development plans and business could be significantly harmed. Further, competitors who are developing products with similar technology may experience problems with their products that could identify problems that would potentially harm our business.

Prior to the Juno-sponsored Phase I trial of JCAR017 and the Phase II clinical trial of JCAR015 that are expected to commence in the near term, third parties had sponsored and conducted all clinical trials of our CD19 product candidates and other product candidates, and our ability to influence the design and conduct of such trials has been limited. We have assumed control over the future clinical and regulatory development of JCAR015 and, for NHL, JCAR017, and may do so for other product candidates, which will entail additional expenses and may be subject to delay. Any failure by a third party to meet its obligations with respect to the clinical and regulatory development of our product candidates may delay or impair our ability to obtain regulatory approval for our products and result in liability for our company.

 

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Prior to the Juno-sponsored Phase I clinical trial of JCAR017 and the Phase II clinical trial of JCAR015, both of which are planned to start in the near term, we had not sponsored any clinical trials relating to our CD19 product candidates or other product candidates. Instead, faculty members at our third-party research institution collaborators, or those institutions themselves, sponsored all clinical trials relating to these product candidates, in each case under their own INDs. We have now assumed control of the overall clinical and regulatory development of JCAR015 and, for NHL, JCAR017 for future clinical trials, and the FDA has cleared Juno-sponsored INDs for the Phase I clinical trial of JCAR017 in r/r NHL and Phase II clinical trial of JCAR015 in adult r/r ALL. We may determine to assume control over the clinical and regulatory development of other product candidates in the future, in which case we will need to obtain sponsorship of the INDs or file new Juno-sponsored INDs. Failure to obtain, or delays in obtaining, sponsorship of INDs or in filing new Juno-sponsored INDs for these or any other product candidates we determine to advance could negatively affect the timing of our potential future clinical trials. Additionally, although MSK received breakthrough therapy designation for JCAR015 from the FDA, we will separately need to request breakthrough therapy designation from the FDA under our own IND, which we may not be successful in obtaining, which could adversely affect the timing of future clinical trials and regulatory review and approval. Any such impacts on timing could increase research and development costs and could delay or prevent obtaining regulatory approval for our most advanced product candidates, either of which could have a material adverse effect on our business.

Further, even in the event that the IND sponsorship is or has been obtained for existing and new INDs, we did not control the design or conduct of the previous trials. It is possible that the FDA will not accept these previous trials as providing adequate support for future clinical trials, whether controlled by us or third parties, for any of one or more reasons, including the safety, purity, and potency of the product candidate, the degree of product characterization, elements of the design or execution of the previous trials or safety concerns, or other trial results. We may also be subject to liabilities arising from any treatment-related injuries or adverse effects in patients enrolled in these previous trials. As a result, we may be subject to unforeseen third-party claims and delays in our potential future clinical trials. We may also be required to repeat in whole or in part clinical trials previously conducted by our third-party research institution collaborators, which will be expensive and delay the submission and licensure or other regulatory approvals with respect to any of our product candidates. Any such delay or liability could have a material adverse effect on our business.

Although we have assumed control of the overall clinical and regulatory development of JCAR015 and, for NHL, JCAR017 going forward, we expect to be dependent on our contractual arrangements with third-party research institution collaborators for ongoing and planned trials for our other product candidates, and for JCAR017 other than in NHL, until we determine to assume control of the clinical and regulatory development of those candidates. Such arrangements provide us certain information rights with respect to certain previous, planned, or ongoing trials with respect to our product candidates, including access to and the ability to use and reference the data, including for our own regulatory filings, resulting from such trials. If these obligations are breached by our third-party research institution collaborators, or if the data, or our data rights, prove to be inadequate compared to the first-hand knowledge we might have gained had the completed trials been Juno-sponsored trials, then our ability to design and conduct our planned corporate-sponsored clinical trials may be adversely affected. Additionally, the FDA may disagree with the sufficiency of our right to reference the preclinical, manufacturing, or clinical data generated by these prior investigator-sponsored trials, or our interpretation of preclinical, manufacturing, or clinical data from these clinical trials. If so, the FDA may require us to obtain and submit additional preclinical, manufacturing, or clinical data before we may begin our planned trials and/or may not accept such additional data as adequate to begin our planned trials.

We may encounter substantial delays in our clinical trials, or may not be able to conduct our trials on the timelines we expect.

Clinical testing is expensive, time consuming, and subject to uncertainty. We cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all. We expect that the early clinical work performed by our third-party research institution collaborators will help support the filing with the FDA of multiple INDs for product candidates in the next five years. However, we cannot be sure that we will be able to submit INDs at this rate, and we cannot be sure that submission of an IND will result in the FDA allowing clinical trials to begin. Moreover, even if these trials begin, issues may arise that could suspend or terminate such clinical trials. A failure of one or more clinical studies can occur at any stage of testing, and our future clinical studies may not be successful. Events that may prevent successful or timely completion of clinical development include:

 

  inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical studies;

 

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  delays in sufficiently developing, characterizing, or controlling a manufacturing process suitable for advanced clinical trials;

 

  delays in reaching a consensus with regulatory agencies on study design;

 

  the FDA may not allow us to use the clinical trial data from a research institution to support an IND if we cannot demonstrate the comparability of our product candidates with the product candidate used by the relevant research institution in its clinical studies;

 

  delays in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical study sites;

 

  delays in obtaining required IRB approval at each clinical study site;

 

  imposition of a temporary or permanent clinical hold by regulatory agencies for a number of reasons, including after review of an IND application or amendment, or equivalent application or amendment; as a result of a new safety finding that presents unreasonable risk to clinical trial participants; a negative finding from an inspection of our clinical study operations or study sites; developments on trials conducted by competitors for related technology that raises FDA concerns about risk to patients of the technology broadly; or if FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives;

 

  delays in recruiting suitable patients to participate in our clinical studies;

 

  difficulty collaborating with patient groups and investigators;

 

  failure by our CROs, other third parties, or us to adhere to clinical study requirements;

 

  failure to perform in accordance with the FDA’s cGCP requirements, or applicable regulatory guidelines in other countries;

 

  delays in having patients complete participation in a study or return for post-treatment follow-up;

 

  patients dropping out of a study;

 

  occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits;

 

  changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;

 

  changes in the standard of care on which a clinical development plan was based, which may require new or additional trials;

 

  the cost of clinical studies of our product candidates being greater than we anticipate;

 

  clinical studies of our product candidates producing negative or inconclusive results, which may result in our deciding, or regulators requiring us, to conduct additional clinical studies or abandon product development programs;

 

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  transfer of manufacturing processes from our academic collaborators to larger-scale facilities operated by either a CMO or by us, and delays or failure by our CMOs or us to make any necessary changes to such manufacturing process;

 

  delays or failure to secure supply agreements with suitable reagent suppliers, or any failures by suppliers to meet our quantity or quality requirements for necessary reagents; and

 

  delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of our product candidates for use in clinical studies or the inability to do any of the foregoing.

Any inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenue. In addition, if we make manufacturing or formulation changes to our product candidates, we may be required to or we may elect to conduct additional studies to bridge our modified product candidates to earlier versions. Clinical study delays could also shorten any periods during which our products have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.

We have entered into collaborations, including our Celgene collaboration, and may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.

We have entered into a number of research and development collaborations, including with Celgene, Fate Therapeutics, Editas Medicine, and MedImmune, and these collaborations are subject to numerous risks, which may include the following:

 

    collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration;

 

    collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products, availability of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities;

 

    collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials, or require a new formulation of a product candidate for clinical testing;

 

    collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;

 

    a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution;

 

    collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;

 

    disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our product candidates, or that result in costly litigation or arbitration that diverts management attention and resources;

 

    collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and

 

    collaborators may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to commercialize such intellectual property.

 

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In particular, if Celgene opts to exercise its options to license any product candidates under the collaboration agreement with us, we may have limited influence or control over their approaches to development and commercialization in the territories in which they lead development and commercialization. Although we will still lead development and commercialization activities in North America for our product candidates arising from programs for which Celgene has exercised an option, Celgene’s development and commercialization activities in the territories where it is the lead party may adversely impact our own efforts in North America. Failure by Celgene to meet its obligations under the collaboration agreement and any co-development or co-commercialization agreement we enter into, or failure by Celgene to apply sufficient efforts at developing and commercializing collaboration products, may materially adversely affect our business and our results of operations. Additionally, Celgene’s exercise of an option for a program that includes a given product candidate may also lead to changes to clinical and regulatory development strategy for such product candidate that may impact previously announce development timelines for such product candidate, which may or may not adversely affect our stock price.

We may form or seek further strategic alliances, create joint ventures or collaborations, or enter into additional licensing arrangements 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 develop. Such alliances will be subject to many of the risks set forth above. Moreover, any of these 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, or disrupt our management and business. In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex.

As a result of these risks, we may not be able to realize the benefit of our existing collaborations or any future collaborations or licensing agreements we may enter into. Any delays in entering into new collaborations or strategic partnership agreements related to our product candidates could delay the development and commercialization of our product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition, and results of operations.

The FDA or comparable foreign regulatory authorities may disagree with our regulatory plans, including our plans to seek accelerated approval, and we may fail to obtain regulatory approval of our product candidates.

We plan to begin a trial in adult relapsed/refractory ALL in the near term with JCAR015 that could support accelerated U.S. regulatory approval. We also plan to begin a Phase I/II trial in adult relapsed/refractory NHL in the near term with JCAR017, with the potential to move to a registration trial in late 2016 or early 2017. We intend to conduct each of these clinical trials in the United States. If the results of these trials are sufficiently compelling, we intend to discuss with the FDA filing BLAs for accelerated approval of such CD19 product candidates as a treatment for patients who are refractory to currently approved treatments in these indications.

The FDA standard for regular approval of a biologic generally requires two adequate and well-controlled Phase III studies or one large and robust, well-controlled Phase III study in the patient population being studied that provides substantial evidence that a biologic is safe, pure and potent. Phase III clinical studies typically involve hundreds of patients, have significant costs and take years to complete. However, product candidates studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may be eligible for accelerated approval and may be approved on the basis of adequate and well-controlled clinical trials establishing that the product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments. As a condition of accelerated approval, the FDA may require a sponsor of a drug or biologic receiving accelerated approval to perform post-marketing studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical endpoint, and the drug or biologic may be subject to withdrawal procedures by the FDA that are more accelerated than those available for regular approvals. We believe our accelerated approval strategy is warranted given the currently limited alternative therapies for patients with relapsed/refractory ALL and relapsed/refractory NHL, but the FDA may not agree. The FDA may ultimately require one or multiple Phase III clinical trials prior to approval, particularly because our product candidates are novel and personalized treatments.

As part of its marketing authorization process, the European Medicines Agency (“EMA”) may grant marketing authorizations on the basis of less complete data than is normally required, when, for certain categories of medicinal

 

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products, doing so may meet unmet medical needs of patients and serve the interest of public health. In such cases, it is possible for the Committee for Medicinal Products for Human Use (“CHMP”) to recommend the granting of a marketing authorization, subject to certain specific obligations to be reviewed annually, which is referred to as a conditional marketing authorization. This may apply to medicinal products for human use that fall under the jurisdiction of the EMA, including those that aim at the treatment, the prevention, or the medical diagnosis of seriously debilitating diseases or life-threatening diseases and those designated as orphan medicinal products.

A conditional marketing authorization may be granted when the CHMP finds that, although comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied, all the following requirements are met:

 

  the risk-benefit balance of the medicinal product is positive;

 

  it is likely that the applicant will be in a position to provide the comprehensive clinical data;

 

  unmet medical needs will be fulfilled; and

 

  the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required.

The granting of a conditional marketing authorization is restricted to situations in which only the clinical part of the application is not yet fully complete. Incomplete nonclinical or quality data may only be accepted if duly justified and only in the case of a product intended to be used in emergency situations in response to public-health threats.

Conditional marketing authorizations are valid for one year, on a renewable basis. The holder will be required to complete ongoing studies or to conduct new studies with a view to confirming that the benefit-risk balance is positive. In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance data.

The granting of a conditional marketing authorization will allow medicines to reach patients with unmet medical needs earlier than might otherwise be the case and will ensure that additional data on a product are generated, submitted, assessed and acted upon. Although we may seek a conditional marketing authorization for one or more of our product candidates by the EMA, the EMA or CHMP may ultimately not agree that the requirements for such conditional marketing authorization have been satisfied.

Our clinical trial results may also not support approval, whether accelerated approval, conditional marketing authorizations, or regular approval. The results of preclinical and clinical studies may not be predictive of the results of later-stage clinical trials, and product candidates in later stages of clinical trials may fail to show the desired safety and efficacy despite having progressed through preclinical studies and initial clinical trials. In addition, our product candidates could fail to receive regulatory approval for many reasons, including the following:

 

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

 

  the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which we seek approval;

 

  we may be unable to demonstrate that our product candidates’ risk-benefit ratios for their proposed indications are acceptable;

 

  the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

 

  we may be unable to demonstrate that the clinical and other benefits of our product candidates outweigh their safety risks;

 

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

 

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  the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;

 

  the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes, our own manufacturing facilities, or a third-party manufacturer’s facilities with which we contract for clinical and commercial supplies; and

 

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

Further, failure to obtain approval for any of the above reasons may be made more likely by the fact that the FDA and other regulatory authorities have very limited experience with commercial development of genetically engineered T cell therapies for cancer. Failure to obtain regulatory approval to market any of our product candidates would significantly harm our business, results of operations, and prospects.

Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which would prevent or delay regulatory approval and commercialization.

The clinical trials of our product candidates are, and the manufacturing and marketing of our products will be, subject to extensive and rigorous review and regulation by numerous government authorities in the United States and in other countries where we intend to test and market our product candidates. Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that our product candidates are both safe and effective for use in each target indication. In particular, because our product candidates are subject to regulation as biological drug products, we will need to demonstrate that they are safe, pure, and potent for use in their target indications. Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use. The risk/benefit profile required for product licensure will vary depending on these factors and may include not only the ability to show tumor shrinkage, but also adequate duration of response, a delay in the progression of the disease, and/or an improvement in survival. For example, response rates from the use of our product candidates may not be sufficient to obtain regulatory approval unless we can also show an adequate duration of response. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. The results of studies in one set of patients or line of treatment may not be predictive of those obtained in another. We expect there may be greater variability in results for products processed and administered on a patient-by-patient basis, as anticipated for our product candidates, than for “off-the-shelf” products, like many other drugs. There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization.

Data from studies conducted by the third-party research institutions that are our collaboration partners, FHCRC, MSK, and SCRI, should not be relied upon as evidence that later or larger-scale clinical trials will succeed. Some future trials may have different patient populations than current studies and will test our product candidates in different indications, among other differences. In addition, our proposed manufacturing processes for our CD19 product candidates include what we believe will be process improvements that are not part of the production processes that are currently being used in the clinical trials being conducted by the research institutions. Accordingly, our results with our CD19 product candidates may not be consistent with the results of the clinical trials being conducted by our research institute collaborators.

In addition, even if such 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. To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates.

 

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

As with most biological drug products, use of our product candidates could be associated with side effects or adverse events which can vary in severity from minor reactions to death and in frequency from infrequent to prevalent. Undesirable side effects or unacceptable toxicities caused by our product candidates could cause us or regulatory authorities to interrupt, delay, or halt clinical trials. We have seen severe neurotoxicity or severe cytokine release syndrome (“sCRS”), in some cases leading to death, in a number of patients with ALL using each of JCAR015, JCAR017, and JCAR014. sCRS is a condition that, by convention, and for our JCAR015 and JCAR017 trials, is currently defined clinically by certain side effects, which can include hypotension, or low blood pressure, and confusion or other central nervous system side effects, related to the release of inflammatory proteins in the body as the CAR T cells rapidly multiply in the presence of the target tumor protein, when such side effects are serious enough to lead to intensive care unit care with mechanical ventilation or significant vasopressor support. For the JCAR014 trial, sCRS is defined as certain side effects, which can include hypotension, confusion, or other central nervous system side effects, when such side effects are CTCAE grade 3 or higher. In early 2014, two patient deaths in the JCAR015 trial, which we believe were either directly or indirectly related to sCRS, resulted in the FDA placing the trial on clinical hold. Several JCAR015 protocol changes were made after those deaths, the most important of which include using a lower dose in patients with morphologic relapsed/refractory ALL, excluding patients with Class III or IV congestive heart failure as defined by the New York Heart Association, excluding patients with active central nervous system leukemia or symptomatic central nervous system leukemia within 28 days, adding sCRS as a dose limiting toxicity, and restricting a patient from receiving a second treatment of JCAR015 if the patient experienced any non-hematologic grade 4 toxicities, including sCRS, with the prior JCAR015 treatment. The protocol changes resulted in the FDA removing the clinical hold. However, these protocol changes may reduce efficacy and may not result in a better tolerability profile. The FDA or comparable foreign regulatory authorities could delay or deny approval of our product candidates for any or all targeted indications and negative side effects could result in a more restrictive label for any product that is approved. Side effects such as toxicity or other safety issues associated with the use of our product candidates could also require us or our collaborators to perform additional studies or halt development or sale of these product candidates.

Treatment-related side effects could also affect patient recruitment or the ability of enrolled subjects to complete the trial, or could result in potential product liability claims. In addition, these side effects may not be appropriately or timely recognized or managed by the treating medical staff, particularly outside of the research institutions that collaborate with us, as toxicities resulting from personalized T cell therapy are not normally encountered in the general patient population and by medical personnel. We expect to have to train medical personnel using our product candidates to understand their side effect profiles, both for our planned clinical trials and upon any commercialization of any product candidates. Inadequate training in recognizing or managing the potential side effects of our product candidates could result in adverse effects to patients, including death. Any of these occurrences may materially and adversely harm our business, financial condition and prospects.

Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, including during any long-term follow-up observation period recommended or required for patients who receive treatment using our products, a number of potentially significant negative consequences could result, including:

 

  regulatory authorities may withdraw approvals of such product;

 

  regulatory authorities may require additional warnings on the label;

 

  we may be required to create a REMS plan, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers, and/or other elements to assure safe use;

 

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

 

  our reputation may suffer.

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

 

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

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. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons, including:

 

  the size and nature of the patient population;

 

  the patient eligibility criteria defined in the protocol;

 

  the size of the study population required for analysis of the trial’s primary endpoints;

 

  the proximity of patients to trial sites;

 

  the design of the trial;

 

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

 

  competing clinical trials for similar therapies or other new therapeutics not involving T cell based immunotherapy;

 

  clinicians’ and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies, including any new drugs or treatments that may be approved for the indications we are investigating;

 

  our ability to obtain and maintain patient consents; and

 

  the risk that patients enrolled in clinical trials will not complete a clinical trial.

In addition, our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients 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. Because 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 at such clinical trial sites. Moreover, because our product candidates represent a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy and hematopoietic cell transplantation, rather than enroll patients in any future clinical trial.

Even if we are able to enroll a sufficient number of patients in our clinical trials, delays in patient enrollment may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our product candidates.

Clinical trials are expensive, time-consuming and difficult to design and implement, and our clinical trial costs may be higher than for more conventional therapeutic technologies or drug products.

Clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. Because our product candidates are based on new technologies and manufactured on a patient-by-patient basis, we expect that they will require extensive research and development and have substantial manufacturing costs. In addition, costs to treat patients with relapsed/refractory cancer and to treat potential side effects that may result from our product candidates can be significant. Some clinical trial sites may not bill, or obtain coverage from, Medicare, Medicaid, or other third-party payors for some or all of these costs for patients enrolled in our clinical trials, and we may be required by those trial sites to pay such costs. Accordingly, our clinical trial costs are likely to be significantly higher per patient than those of more conventional therapeutic technologies or drug products. In addition, our proposed personalized product candidates involve several complex and costly manufacturing and processing steps, the costs of which will be borne by us. Depending on the number of patients we ultimately enroll in our trials, and the number of trials we may need to conduct, our overall clinical trial costs may be higher than for more conventional treatments.

 

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Research and development of biopharmaceutical products is inherently risky. We may not be successful in our efforts to use and enhance our technology platform and CAR and TCR technologies to create a pipeline of product candidates and develop commercially successful products, or we may expend our limited resources on programs that do not yield a successful product candidate and fail to capitalize on product candidates or diseases that may be more profitable or for which there is a greater likelihood of success. If we fail to develop additional product candidates, our commercial opportunity will be limited.

Although our most advanced product candidates are JCAR015, JCAR017, and JCAR014, we and our collaborators are simultaneously pursuing clinical development of additional product candidates developed employing our CAR and TCR technologies. We are at an early stage of development and our technology platform has not yet led, and may never lead, to approved or commercially successful products.

Even if we are successful in continuing to build our pipeline, obtaining regulatory approvals and commercializing additional product candidates may require substantial additional funding and are prone to the risks of failure inherent in medical product development.

Investment in biopharmaceutical product development involves 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. We cannot provide you any assurance that we will be able to successfully advance any of these additional product candidates through the development process. Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development or commercialization for many reasons, including the following:

 

  our platform may not be successful in identifying additional product candidates;

 

  we may not be able or willing to assemble sufficient resources to acquire or discover additional product candidates;

 

  our product candidates may not succeed in preclinical or clinical testing;

 

  a product candidate may on further study be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;

 

  competitors may develop alternatives that render our product candidates obsolete or less attractive;

 

  product candidates we develop may nevertheless be covered by third parties’ patents or other exclusive rights;

 

  the market for a product candidate may change during our program so that the continued development of that product candidate is no longer reasonable;

 

  a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and

 

  a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors, if applicable.

If any of these events occur, we may be forced to abandon our development efforts for a program or programs, or we may not be able to identify, discover, develop, or commercialize additional product candidates, which would have a material adverse effect on our business and could potentially cause us to cease operations.

Even if we receive FDA approval to market additional product candidates, whether for the treatment of cancers or other diseases, we cannot assure you that any such product candidates will be successfully commercialized, widely accepted in the marketplace or more effective than other commercially available alternatives. Further, because of our limited financial and managerial resources, we are required to focus our research programs on certain product candidates and on specific diseases. As a result, we may fail to capitalize on viable commercial products or

 

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profitable market opportunities, be required to forego or delay pursuit of opportunities with other product candidates or other diseases that may later prove to have greater commercial potential, or relinquish valuable rights to such product candidates through collaboration, licensing or other royalty arrangements in cases in which it would have been advantageous for us to retain sole development and commercialization rights. For additional information regarding the factors that will affect our ability to achieve revenue from product sales, see the risk factor above “— We have never generated any revenue from product sales and our ability to generate revenue from product sales and become profitable depends significantly on our success in a number of factors.

Our product candidates are biologics and the manufacture of our product candidates is complex and we may encounter difficulties in production, particularly with respect to process development or scaling-out of our manufacturing capabilities. If we or any of our third-party manufacturers encounter such difficulties, our ability to provide supply of our product candidates for 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.

Our product candidates are biologics and the process of manufacturing our products is complex, highly-regulated and subject to multiple risks. The manufacture of our product candidates involves complex processes, including harvesting T cells from patients, genetically modifying the T cells ex vivo, multiplying the T cells to obtain the desired dose, and ultimately infusing the T cells back into a patient’s body. As a result of the complexities, the cost to manufacture biologics in general, and our genetically modified cell product candidates in particular, is generally higher than traditional small molecule chemical compounds, and the manufacturing process is less reliable and is more difficult to reproduce. Our manufacturing process will be susceptible to product loss or failure due to logistical issues associated with the collection of white blood cells, or starting material, from the patient, shipping such material to the manufacturing site, shipping the final product back to the patient, and infusing the patient with the product, manufacturing issues associated with the differences in patient starting materials, interruptions in the manufacturing process, contamination, equipment or reagent failure, improper installation or operation of equipment, vendor or operator error, inconsistency in cell growth, and variability in product characteristics. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, and other supply disruptions. If for any reason we lose a patient’s starting material or later-developed product at any point in the process, the manufacturing process for that patient will need to be restarted and the resulting delay may adversely affect that patient’s outcome. If microbial, viral, or other contaminations are discovered in our product candidates or in the manufacturing facilities in which our product candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. Because our product candidates are manufactured for each particular patient, we will be required to maintain a chain of identity with respect to materials as they move from the patient to the manufacturing facility, through the manufacturing process, and back to the patient. Maintaining such a chain of identity is difficult and complex, and failure to do so could result in adverse patient outcomes, loss of product, or regulatory action including withdrawal of our products from the market. Further, as product candidates are developed through preclinical to late stage clinical trials towards approval and commercialization, 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 clinical trials or other future clinical trials.

Historically, our product candidates have been manufactured using unoptimized processes by our third-party research institution collaborators that we do not intend to use for more advanced clinical trials or commercialization. Although we are working to develop commercially viable 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-out, process reproducibility, stability issues, lot consistency, and timely availability of reagents or raw materials. As a result of these challenges, we may experience delays in our clinical development and/or commercialization plans. We may ultimately be unable to reduce the cost of goods for our product candidates to levels that will allow for an attractive return on investment if and when those product candidates are commercialized.

In some circumstances, changes in the manufacturing process may require us to perform both ex vivo comparability studies and to collect additional data from patients prior to undertaking more advanced clinical trials. For instance, changes we are making to the manufacturing process, including changes in reagents and in the viral vector, in preparation for our Phase II trial for JCAR015 will require us to show the comparability of the Phase II product to Phase I product. We plan to provide the FDA with comparability evidence from ex vivo experimental studies comparing Phase I product to Phase II product, as well as clinical comparability data from our planned Phase II trial. We also plan to make further changes to our manufacturing process prior to commercialization, and such changes

 

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will also require us to show the comparability of the resulting product to the product used in the clinical trials using the earlier process. We may be required to collect additional clinical data from the modified process prior to obtaining marketing approval for the product candidate produced with the modified process. If clinical data is not ultimately comparable to that seen in the earlier trials in terms of safety or efficacy, we may be required to make further changes to our process and/or undertake additional clinical testing, either of which could significantly delay the clinical development of JCAR015.

We expect our manufacturing strategy will involve the use of one or more CMOs as well as establishing our own capabilities and infrastructure, including a manufacturing facility to manufacture our product candidates. We also plan to manufacture certain of the reagents used for making our product candidates ourselves. We expect that development of our own manufacturing facility, as well as manufacturing some of our own reagents, will provide us with enhanced control of material supply for both clinical trials and the commercial market, enable the more rapid implementation of process changes, and allow for better long-term margins. However, we have no experience as a company in developing a manufacturing facility or in manufacturing reagents and may never be successful in developing our own manufacturing facility or capability or in manufacturing reagents in sufficient quantities or with sufficient quality for clinical or commercial use. We may establish multiple manufacturing facilities as we expand our commercial footprint to multiple geographies, which may lead to regulatory delays or prove costly. Even if we are successful, our manufacturing capabilities could be affected by cost-overruns, unexpected delays, equipment failures, labor shortages, natural disasters, power failures, and numerous other factors that could prevent us from realizing the intended benefits of our manufacturing strategy and have a material adverse effect on our business.

In addition, the manufacturing process for any products that we may develop is subject to FDA and foreign regulatory authority approval process, and we will need to contract with manufacturers who can meet all applicable FDA and foreign regulatory authority requirements on an ongoing basis. If we or our CMOs are unable to reliably produce products to specifications acceptable to the FDA or other regulatory authorities, we may not obtain or maintain the approvals we need to commercialize such products. Even if we obtain regulatory approval for any of our product candidates, there is no assurance that either we or our CMOs will be able to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product, or to meet potential future demand. Any of these challenges could delay completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidate, impair commercialization efforts, increase our cost of goods, and have an adverse effect on our business, financial condition, results of operations and growth prospects.

We expect to rely on third parties to manufacture our clinical product supplies, and we intend to rely on third parties for at least a portion of the manufacturing process of our product candidates, if approved. Our business could be harmed if those third parties fail to provide us with sufficient quantities of product or fail to do so at acceptable quality levels or prices.

We currently rely on outside vendors to manufacture supplies and process our product candidates, which is and will need to be done on a patient-by-patient basis. We have not yet caused our product candidates to be manufactured or processed on a commercial scale and may not be able to do so for any of our product candidates. Although our manufacturing and processing approach is based upon the current approach undertaken by our third-party research institution collaborators, we have limited experience in managing the T cell engineering process, and our process may be more difficult or expensive than the approaches currently in use. We will make changes as we work to optimize the manufacturing process, and we cannot be sure that even minor changes in the process will not result in significantly different T cells that may not be as safe and effective as any T cell therapy deployed by our third-party research institution collaborators.

Although we do intend to develop our own manufacturing facility, and we have leased a facility that we intend to build out to support our clinical and commercial manufacturing activities, we also intend to continue to use third parties as part of our manufacturing process and may, in any event, never be successful in developing our own manufacturing facility. Our anticipated reliance on a limited number of third-party manufacturers exposes us to the following risks:

 

  We may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and the FDA must approve any manufacturers. This approval would require new testing and good manufacturing practices compliance inspections by FDA. In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production of our products.

 

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  Our manufacturers may have little or no experience with autologous cell products, which are products made from a patient’s own cells, and therefore may require a significant amount of support from us in order to implement and maintain the infrastructure and processes required to manufacture our product candidates.

 

  Our third-party manufacturers might be unable to timely manufacture our product or produce the quantity and quality required to meet our clinical and commercial needs, if any.

 

  Contract manufacturers may not be able to execute our manufacturing procedures and other logistical support requirements appropriately.

 

  Our future contract manufacturers may not perform as agreed, may not devote sufficient resources to our products, or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store, and distribute our products.

 

  Manufacturers are subject to ongoing periodic unannounced inspection by the FDA and corresponding state agencies to ensure strict compliance with cGMPs and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers’ compliance with these regulations and standards.

 

  We may not own, or may have to share, the intellectual property rights to any improvements made by our third-party manufacturers in the manufacturing process for our products.

 

  Our third-party manufacturers could breach or terminate their agreement with us.

 

  Raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier, may not be available or may not be suitable or acceptable for use due to material or component defects.

 

  Our contract manufacturers and critical reagent suppliers may be subject to inclement weather, as well as natural or man-made disasters.

 

  Our contract manufacturers may have unacceptable or inconsistent product quality success rates and yields.

Each of these risks could delay or prevent the completion of our clinical trials or the approval of any of our product candidates by the FDA, result in higher costs or adversely impact commercialization of our product candidates. In addition, we will rely on third parties to perform certain specification tests on our product candidates prior to delivery to patients. If these tests are not appropriately done and test data are not reliable, patients could be put at risk of serious harm and the FDA could require additional clinical trials or place significant restrictions on our company until deficiencies are remedied.

The manufacture of biological drug products is complex and requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls.

Manufacturers of biologic products often encounter difficulties in production, particularly in scaling up or out, validating the production process, and assuring high reliability of the manufacturing process (including the absence of contamination). These problems include logistics and shipping, difficulties with production costs and yields, quality control, including stability of the product, product testing, operator error, availability of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations. Furthermore, if contaminants are discovered in our supply of our product candidates or in the manufacturing facilities, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. We cannot assure you that any stability failures or other issues relating to the manufacture of our product candidates will not occur in the future. Additionally, our manufacturers may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstable political environments. If our manufacturers were to encounter any of these difficulties, or otherwise fail to comply with their contractual obligations, our ability to provide our product candidate to patients in clinical trials would be jeopardized. Any delay or interruption in the supply of clinical trial supplies could delay the completion of clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require us to begin new clinical trials at additional expense or terminate clinical trials completely.

 

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Cell-based therapies rely on the availability of reagents, specialized equipment, and other specialty materials, which may not be available to us on acceptable terms or at all. For some of these reagents, equipment, and materials, we rely or may rely on sole source vendors or a limited number of vendors, which could impair our ability to manufacture and supply our products.

Manufacturing our product candidates will require many reagents, which are substances used in our manufacturing processes to bring about chemical or biological reactions, and other specialty materials and equipment, some of which are manufactured or supplied by small companies with limited resources and experience to support commercial biologics production. We currently depend on a limited number of vendors for certain materials and equipment used in the manufacture of our product candidates. Some of these suppliers may not have the capacity to support commercial products manufactured under cGMP by biopharmaceutical firms or may otherwise be ill-equipped to support our needs. We also do not have supply contracts with many of these suppliers and may not be able to obtain supply contracts with them on acceptable terms or at all. Accordingly, we may experience delays in receiving key materials and equipment to support clinical or commercial manufacturing.

For some of these reagents, equipment, and materials, we rely and may in the future rely on sole source vendors or a limited number of vendors. An inability to continue to source product from any of these suppliers, which could be due to regulatory actions or requirements affecting the supplier, adverse financial or other strategic developments experienced by a supplier, labor disputes or shortages, unexpected demands, or quality issues, could adversely affect our ability to satisfy demand for our product candidates, which could adversely and materially affect our product sales and operating results or our ability to conduct clinical trials, either of which could significantly harm our business.

As we continue to develop and scale our manufacturing process, we expect that we will need to obtain rights to and supplies of certain materials and equipment to be used as part of that process. We may not be able to obtain rights to such materials on commercially reasonable terms, or at all, and if we are unable to alter our process in a commercially viable manner to avoid the use of such materials or find a suitable substitute, it would have a material adverse effect on our business. Even if we are able to alter our process so as to use other materials or equipment, such a change may lead to a delay in our clinical development and/or commercialization plans. If such a change occurs for product candidate that is already in clinical testing, the change may require us to perform both ex vivo comparability studies and to collect additional data from patients prior to undertaking more advanced clinical trials.

We are and will continue to rely in significant part on outside scientists and their third-party research institutions for research and development and early clinical testing of our product candidates. These scientists and institutions may have other commitments or conflicts of interest, which could limit our access to their expertise and harm our ability to leverage our technology platform.

We rely to a large extent at present on our third-party research institution collaborators for research and development capabilities. Currently, MSK is conducting Phase I clinical trials using JCAR015 to address adult ALL and pediatric ALL; SCRI is conducting a Phase I/II clinical trial using JCAR017 to address pediatric ALL; and FHCRC is conducting a Phase I/II clinical trial using JCAR014 to address ALL, NHL, and CLL. Each of these clinical trials addresses a limited number of patients. We expect to use the results of these trials to help support the filing with the FDA of INDs to conduct more advanced clinical trials with one or more of our CD19 product candidates. To date, we have filed, and the FDA has cleared, a Juno-sponsored IND for the Phase I clinical trial of JCAR017 and a Juno-sponsored IND for the Phase II clinical trial of JCAR015, and these Juno-sponsored trials are expected to commence in the near term.

With respect to our CD22 product candidate, JCAR018, the NCI is conducting a clinical trial of the product candidate for the treatment of pediatric relapsed/refractory ALL and relapsed/refractory NHL. If the results of this trial are compelling, we expect to use the results of the NCI’s clinical trial to support the filing with the FDA of a Juno-sponsored IND to conduct more advanced clinical trials of JCAR018.

We also fund research and development under agreements with FHCRC, MSK, and SCRI. However, the research we are funding constitutes only a small portion of the overall research of each research institution. Other research being conducted by these institutions may at times receive higher priority than research on the programs we are funding.

The outside scientists who conduct the clinical testing of our current product candidates, and who conduct the research and development upon which our product candidate pipeline depends, are not our employees; rather they

 

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serve as either independent contractors or the primary investigators under research collaboration agreements that we have with their sponsoring academic or research institution. Such scientists and collaborators may have other commitments that would limit their availability to us. Although our scientific advisors generally agree not to do competing work, if an actual or potential conflict of interest between their work for us and their work for another entity arises, we may lose their services. These factors could adversely affect the timing of the clinical trials, the timing of receipt and reporting of clinical data, the timing of Juno-sponsored IND filings, and our ability to conduct future planned clinical trials. It is also possible that some of our valuable proprietary knowledge may become publicly known through these scientific advisors if they breach their confidentiality agreements with us, which would cause competitive harm to, and have a material adverse effect on, our business.

Our existing agreements with our collaboration partners may be subject to termination by the counterparty upon the occurrence of certain circumstances as described in more detail under the caption “Licenses and Third-Party Research Collaborations” in Part I—Item 1—“Business” of our 2014 Annual Report. If any of our collaboration partners terminates their collaboration agreement, the research and development of the relevant product candidate would be suspended, and we may be unable to research, develop, and license future product candidates. We may be required to devote additional resources to the development of our product candidates or seek a new collaboration partner, and the terms of any additional collaborations or other arrangements that we establish may not be favorable to us. In addition, there is a natural transition period when a new third-party begins work. In addition, switching or adding third parties to conduct our clinical trials involves substantial cost and requires extensive management time and focus. As a result, delays may occur, which can materially impact our ability to meet our desired clinical development timelines.

We will be highly dependent on the NCI for early clinical testing of JCAR018.

In December 2014, we entered into an exclusive license agreement with Opus Bio pursuant to which Opus Bio has granted us an exclusive, worldwide, sublicenseable license under certain patent rights related to a CD22-directed CAR product candidate, JCAR018. In connection therewith, the National Cancer Institute (“NCI”) agreed to separate the activities that are exclusively related to CD22 under its agreement with Opus Bio and to enter into a separate agreement with us (the “Juno CRADA”), on the same terms as such agreement and incorporate such activities into its agreement with us.

The NCI has commenced a Phase I clinical trial of JCAR018 for the treatment of pediatric relapsed/refractory ALL and relapsed/refractory NHL. If the results of this trial are compelling, we expect to use the results of the NCI’s clinical trial to support the filing with the FDA of a Juno-sponsored IND to conduct more advanced clinical trials of JCAR018. However, we will have limited control over the nature or timing of the NCI’s clinical trial and limited visibility into their day-to-day activities. For example, the clinical trial will constitute only a small portion of the NCI’s overall research and the research of the principal investigators. Other research being conducted by the principal investigators may at times receive higher priority than research on JCAR018. We will also be dependent on the NCI to provide us with data, include batch records, to support the filing of our IND. These factors could adversely affect the timing of our IND filing.

The NCI may unilaterally terminate our rights under the Juno CRADA at any time for any reason or for no reason upon at least 60 days prior written notice. If the NCI unilaterally terminates the Juno CRADA, the research and development under the Juno CRADA would be suspended and we may lose certain of our data rights, which may impair our ability to obtain regulatory approval of JCAR018.

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

Our operations have required substantial amounts of cash since inception. We expect to continue to spend substantial amounts to continue the clinical development of our product candidates, including our planned clinical trials for our CD19 product candidates. If approved, we will require significant additional amounts in order to launch and commercialize our product candidates.

As of June 30, 2015, we had $313.4 million in cash, cash equivalents, and marketable securities. In August 2015, we received $1.0 billion from Celgene from the sale of common stock to Celgene and from the initial payment under our collaboration agreement. We believe that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operations for at least the next 12 months. However, changing circumstances

 

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may cause us to increase our spending significantly faster than we currently anticipate, and we may need to spend more money than currently expected because of circumstances beyond our control. We may require additional capital for the further development and commercialization of our product candidates and may need to raise additional funds sooner if we choose to expand more rapidly than we presently anticipate.

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. Our license and collaboration agreements may also be terminated if we are unable to meet the payment obligations under the agreements. We could be required to seek additional 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.

If Celgene declines to exercise its option with respect to one or more product candidates covered by our collaboration agreement with Celgene, or terminates the collaboration agreement with us, we will need to secure funding to advance development of those programs on our own or secure relationships with collaborators that have the necessary capital and expertise. In addition, we may need additional funding to advance product candidates prior to Celgene’s decisions regarding option exercise with respect to such product candidate if development of that program is not discontinued. In addition, if we exercise our option to any of Celgene’s in-licensed programs to co-develop and co-commercialize products, then we may need to secure additional funding to support our obligations to pay one-half of the acquisition costs of any such in-licensed program.

If we are unable to obtain sufficient financing when needed, it could significantly harm our business, prospects, financial condition and results of operations and cause the price of our common stock to decline.

 

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Any future revenue from the license agreement with Penn and Novartis is highly dependent upon milestone and contingent royalty payments generated from the efforts of Penn and Novartis, over which we have no control, and we may not realize the intended benefits of this agreement.

On April 4, 2015, the parties to Trustees of the University of Pennsylvania v. St. Jude Children’s Research Hospital , Civil Action No. 2:13-cv-01502-SD (E.D. Penn.), agreed to settle the case, which was dismissed on April 7, 2015. In connection with this settlement we entered into a sublicense agreement with Penn and an affiliate of Novartis pursuant to which we granted Novartis a non-exclusive, royalty-bearing sublicense under certain patent rights, including U.S. Patent No. 8,399,645, to develop, make and commercialize licensed products and licensed services for all therapeutic, diagnostic, preventative and palliative uses. In exchange for this sublicense, Novartis is obligated to pay us mid-single digit royalties on the U.S. net sales of products and services related to the disputed contract and patent claims, a low double digit percentage of the royalties Novartis pays to Penn for global net sales of those products, and milestone payments upon the achievement of specified clinical, regulatory and commercialization milestones for licensed products. The sublicense agreement with Novartis and Penn is terminable by Novartis at will without notice to us and without our consent.

Our receipt of royalty and milestone payments from Novartis is subject to many risks and uncertainties. In particular, these payments are dependent upon Novartis’ ability to make U.S. and global sales of its products and services, and its ability to achieve clinical, regulatory and commercialization milestones for the licensed products. We will have no control over the nature or timing of Novartis’ efforts towards making these sales or achieving these milestones. Furthermore, in the course of developing and commercializing its products, Novartis and Penn will likely be subject to many risks and uncertainties similar to those faced by our company and our product candidates as described in this section, and may be subject to other risks specific to Novartis and Penn. Additionally, if Novartis or Penn breaches our sublicense agreement, we may determine to terminate the agreement, or may be required to do so by St. Jude pursuant to the terms of our license agreement with St. Jude. To the extent Novartis fails, for any of the reasons outlined above or any other reason, to remit royalty payments or milestone payments under our sublicense agreement, or fails to remit these payments in the amount anticipated, or to the extent that our sublicense agreement with Novartis and Penn is terminated, we may not realize the potential benefits of the sublicense agreement with Penn and Novartis.

We will rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize our product candidates.

We will depend upon independent investigators to conduct our clinical trials under agreements with universities, medical institutions, CROs, strategic partners, and others. 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 third parties over the course of our clinical trials, and as a result will have limited control over the clinical investigators and limited visibility into their day-to-day activities, including with respect to how they are providing and administering T cell therapy. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol and 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 cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development. Regulatory authorities enforce these cGCPs through periodic inspections of trial sponsors, principal investigators, and trial sites. If we or any of these third parties fail to comply with applicable cGCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional nonclinical or clinical trials before approving our marketing applications. We cannot be certain that, upon inspection, such regulatory authorities will determine that any of our clinical trials comply with the cGCP regulations. In addition, our clinical trials must be conducted with biologic product produced under cGMP regulations and will require a large number of test patients. 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 clinical 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.

Any third parties conducting our clinical trials are not and 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

 

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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 clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical 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 have disclosed in our 2014 Annual Report certain third party investigator-reported interim data from some of our trials, including interim data for which we have not yet independently reviewed the source data. We also sometimes rely on such investigator-reported interim data in making business decisions. Independent review of the data could fail to confirm the investigator- reported interim data, which may lead to revisions in disclosed clinical trial results in the future. Any such revisions that reveal more negative data than previously disclosed investigator-reported interim data could have an adverse impact on our business prospects and the trading price of our common stock. Such revisions could also reduce investor confidence in investigator-reported interim data that we disclose in the future.

If any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable terms. Switching or adding additional CROs involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO begins work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition, and prospects.

The market opportunities for our product candidates may be limited to those patients who are ineligible for or have failed prior treatments and may be small.

Cancer therapies are sometimes characterized as first line, second line, or third line, and the FDA often approves new therapies initially only for third line use. When cancer is detected early enough, first line therapy is sometimes adequate to cure the cancer or prolong life without a cure. Whenever first line therapy, usually chemotherapy, hormone therapy, surgery, or a combination of these, proves unsuccessful, second line therapy may be administered. Second line therapies often consist of more chemotherapy, radiation, antibody drugs, tumor targeted small molecules, or a combination of these. Third line therapies can include bone marrow transplantation, antibody and small molecule targeted therapies, more invasive forms of surgery, and new technologies. We expect to initially seek approval of our product candidates as a third line therapy for patients who have failed other approved treatments. Subsequently, for those products that prove to be sufficiently beneficial, if any, we would expect to seek approval as a second line therapy and potentially as a first line therapy, but there is no guarantee that our product candidates, even if approved, would be approved for second line or first line therapy. In addition, we may have to conduct additional clinical trials prior to gaining approval for second line or first line therapy.

Our projections of both the number of people who have the cancers we are targeting, as well as the subset of people with these cancers in a position to receive third line therapy and who have the potential to benefit from treatment with our product candidates, are based on our beliefs and estimates. These estimates have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations, or market research and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these cancers. The number of patients may turn out to be lower than expected. Additionally, the potentially addressable patient population for our product candidates may be limited or may not be amenable to treatment with our product candidates. For instance, with our CD19 product candidates we expect to initially target a small patient population that suffers from ALL and certain types of aggressive NHL. Even if we obtain significant market share for our product candidates, because the potential target populations are small, we may never achieve profitability without obtaining regulatory approval for additional indications, including use as a first or second line therapy.

Our market opportunities may also be limited by competitor treatments that may enter the market. See the risk factor below “ —We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.

 

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We plan to seek orphan drug status for some or all of our CD19 product candidates, but we may be unable to obtain such designations or to maintain the benefits associated with orphan drug status, including market exclusivity, which may cause our revenue, if any, to be reduced.

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States when there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States will be recovered from sales in the United States for that drug or biologic. Orphan drug designation must be requested before submitting a BLA. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

If a product that has orphan drug designation subsequently receives the first FDA approval for a particular active ingredient for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a BLA, to market the same biologic for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. As a result, even if one of our drug candidates receives orphan exclusivity, the FDA can still approve other drugs that have a different active ingredient for use in treating the same indication or disease. Furthermore, the FDA can waive orphan exclusivity if we are unable to manufacture sufficient supply of our product.

We plan to seek orphan drug designation for some or all of our CD19 product candidates in specific orphan indications in which there is a medically plausible basis for the use of these products, including relapsed/ refractory ALL and relapsed/refractory NHL indications. We have obtained orphan drug designation for each of JCAR015 and JCAR014 for the treatment of ALL. Even when we obtain orphan drug designation, exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition. In addition, although we intend to seek orphan drug designation for other product candidates, we may never receive such designations.

We plan to seek but may fail to obtain breakthrough therapy designation for some or all of our CD19 product candidates.

In 2012, the FDA established a breakthrough therapy designation which is intended to expedite the development and review of products that treat serious or life-threatening diseases when “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.” The designation of a product candidate as a breakthrough therapy provides potential benefits that include more frequent meetings with FDA to discuss the development plan for the product candidate and ensure collection of appropriate data needed to support approval; more frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers; intensive guidance on an efficient drug development program, beginning as early as Phase I; organizational commitment involving senior managers; and eligibility for rolling review and priority review.

Breakthrough therapy designation does not change the standards for product approval. We intend to seek breakthrough therapy designation for some or all of our CD19 product candidates that may qualify for such designation. Our collaborator MSK obtained breakthrough therapy designation for JCAR015 for relapsed/refractory ALL, but we will have to seek such designation separately under our own IND, which we may not receive. In addition, although we intend to seek breakthrough therapy designation for other product candidates, we may never receive such designations.

 

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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 on our own or through our collaboration with Celgene 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 commercial product distribution capabilities and have no experience as a company in marketing products. We intend to 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 pharmaceutical and biotechnology companies to recruit, hire, train, and retain marketing and sales personnel.

Under our collaboration with Celgene, for Juno-developed programs that Celgene opts into, Celgene will lead development and commercialization activities outside of North America and, for cellular therapy product candidates, China, but we will still be responsible for leading such activities in North America and, for cellular therapy product candidates, China. If Celgene does not opt into a program for one of our product candidates that we move to commercialization, we will alone be responsible for commercialization activities worldwide, unless we find another collaborator to assist with the sales and marketing of our products.

If we are unable or decide not to establish internal sales, marketing and commercial distribution capabilities for any or all products we develop, we will likely pursue further 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, or if we are able to do so, that they will have effective 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.

There can be no assurance that we will be able to develop in-house sales and commercial distribution capabilities or establish or maintain relationships with third-party collaborators to successfully commercialize any product in the United States or overseas, and as a result, we may not be able to generate product revenue.

A variety of risks associated with operating our business internationally could materially adversely affect our business.

As a result of the Stage acquisition, we acquired a German subsidiary with employees in Germany. We also plan to seek regulatory approval of our product candidates outside of the United States. Accordingly, we expect that we, and any potential collaborators that have operations in foreign jurisdictions, will be subject to additional risks related to operating in foreign countries, including:

 

  differing regulatory requirements in foreign countries;

 

  unexpected changes in tariffs, trade barriers, price and exchange controls, and other regulatory requirements;

 

  economic weakness, including inflation, or political instability in particular foreign economies and markets;

 

  compliance with applicable tax, employment, immigration, data privacy, and labor laws for employees living or traveling abroad, including for our German employees;

 

  foreign taxes, including withholding of payroll taxes;

 

  foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;

 

  difficulties staffing and managing foreign operations;

 

  workforce uncertainty in countries where labor unrest is more common than in the United States;

 

  potential liability under the Foreign Corrupt Practices Act of 1977 or comparable foreign laws;

 

  challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;

 

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  production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

 

  business interruptions resulting from geo-political actions, including war and terrorism.

These and other risks associated with our planned international operations may materially adversely affect our ability to attain or maintain profitable operations.

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

The biopharmaceutical industry, and the rapidly evolving market for developing genetically engineered T cells in particular, is characterized by intense competition and rapid innovation. Our competitors may be able to develop other compounds or drugs that are able to achieve similar or better results. Our potential competitors include major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, universities, and other research institutions. Many of our competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations as well as established sales forces. Smaller or early- stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. Our competitors, either alone or with collaborative partners, may succeed in developing, acquiring or licensing on an exclusive basis drug or biologic products that are more effective, safer, more easily commercialized, or less costly than our product candidates or may develop proprietary technologies or secure patent protection that we may need for the development of our technologies and products.

Specifically, genetically engineering T cells faces significant competition in both the CAR and TCR technology space from multiple companies and their collaborators, such as Novartis/University of Pennsylvania, bluebird bio, Kite Pharma/NCI, Unum Therapeutics, Bellicum, Celyad, NantKwest, Johnson & Johnson/Transposagen Biopharmaceuticals, Autolus, Cellectis/Pfizer, Adaptimmune/GSK, and Intrexon/Ziopharm/MD Anderson Cancer Center. We face competition from non-cell based treatments offered by other companies such as Amgen, AstraZeneca, Bristol-Myers, Incyte, Merck, and Roche. For instance, the FDA recently granted accelerated approval to Amgen’s blinotumomab for the treatment of relapsed/refractory ALL, and that product has demonstrated a complete remission rate of approximately 40% in clinical trials. Even if we obtain regulatory approval of our product candidates, we may not be the first to market and that may affect the price or demand for our product candidates. Additionally, the availability and price of our competitors’ products could limit the demand and the price we are able to charge for our product candidates. We may not be able to implement our business plan if the acceptance of our product candidates is inhibited by price competition or the reluctance of physicians to switch from existing methods of treatment to our product candidates, or if physicians switch to other new drug or biologic products or choose to reserve our product candidates for use in limited circumstances. Additionally, a competitor could obtain orphan product exclusivity from the FDA with respect to such competitor’s product. If such competitor product is determined to be the same product as one of our product candidates, that may prevent us from obtaining approval from the FDA for such product candidate for the same indication for seven years, except in limited circumstances.

For additional information regarding our competition, see the section captioned “Competition” in Part I—Item 1—“Business” of our 2014 Annual Report.

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

Our ability to compete in the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract, motivate and retain highly qualified managerial, scientific and medical personnel. We are highly dependent on our management, particularly our chief executive officer, Hans Bishop, and our scientific and medical personnel. 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.

 

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We conduct most of our operations at our facility in Seattle, Washington, in a region that is headquarters to many other biopharmaceutical companies and many academic and research institutions. As a result of our acquisition of X-Body and Stage, we have also expanded our operations into Massachusetts and Germany and currently have employees in both geographies. Competition for skilled personnel is intense in all of these geographies and the turnover rate can be high, which may limit our ability to hire and retain highly qualified personnel on acceptable terms or at all. We expect that we will need to recruit talent from outside of the regions in which we currently operate, and doing so may be costly and difficult. Further expansion into additional states or countries could also increase our regulatory and legal risks.

To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have provided restricted stock and stock option grants that vest over time. The value to employees of these equity grants 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. 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 all of these individuals or the lives of any of our other employees.

We will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.

As of June 30, 2015, we had 206 employees worldwide, most of whom are full time. As our development and commercialization plans and strategies develop, and as we transition into operating as a public company, we must add a significant number of additional research and development, managerial, operational, sales, marketing, financial, and other personnel. Future growth will impose significant added responsibilities on members of management, including:

 

  identifying, recruiting, integrating, maintaining, and motivating additional employees;

 

  managing our internal development efforts effectively, including the clinical and FDA review process for our product candidates, while complying with our contractual obligations to contractors and other third parties; and

 

  improving our operational, financial and management controls, reporting systems, and procedures.

Our future financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities. Our efforts to manage our growth are complicated by the fact that all of our executive officers other than our chief executive officer have joined us since January 2014. This lack of long-term experience working together may adversely impact our senior management team’s ability to effectively manage our business and growth.

We currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants to provide certain services. There can be no assurance that the services of these independent organizations, advisors and consultants will continue to be available to us on a timely basis when needed, or that we can find qualified replacements. In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided by consultants is compromised for any reason, our clinical trials may be extended, delayed, or terminated, and we may not be able to obtain regulatory approval of our product candidates or otherwise advance our business. There can be no assurance that we will be able to manage our existing consultants or find other competent outside contractors and consultants on economically reasonable terms, if at all.

If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our research, development, and commercialization goals.

 

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We have engaged in and may in the future engage in acquisitions or strategic partnerships, which could divert management’s attention, increase our capital requirements, dilute our stockholders, be difficult to integrate, cause us to incur debt or assume contingent liabilities, and subject us to other risks.

We have made or entered into several acquisitions or strategic partnerships, and we may continue to evaluate various acquisitions and strategic partnerships, including licensing or acquiring complementary products, intellectual property rights, technologies, or businesses. For instance, in May 2015, we acquired all the outstanding equity interests in Stage, in connection with which we paid €52.5 million in cash and issued 486,279 shares of common stock as an upfront payment, with potential earn out payments of up to €135.0 million in cash based on the achievement of certain technical, clinical, regulatory, and commercial milestones.

Any acquisition or strategic partnership may entail numerous risks, including:

 

  increased operating expenses and cash requirements;

 

  the assumption of additional indebtedness or contingent liabilities;

 

  the issuance of our equity securities;

 

  assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new personnel;

 

  the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition;

 

  retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships;

 

  expense or diversion of efforts related to the development of acquired technology under any diligence obligation required of us with respect to earn out milestones for an acquisition transaction, where we may not undertake such expense or efforts absent such diligence obligations;

 

  risk that the other party or parties to an acquisition transaction may claim that we have not satisfied any earn out diligence obligation and seek damages or other legal or equitable relief;

 

  risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals; and

 

  our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.

In addition, if we undertake additional acquisitions, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense. We also cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that justifies such transaction. Moreover, we may not be able to locate suitable acquisition opportunities and this inability could impair our ability to grow or obtain access to technology or products that may be important to the development of our business.

Our success payment obligations to FHCRC and MSK may result in dilution to our stockholders, may be a drain on our cash resources, or may cause us to incur debt obligations to satisfy the payment obligations.

We have agreed to make success payments to each of FHCRC and MSK pursuant to the terms of our agreements with each of those entities. These success payments will be based on increases in the estimated fair value of our common stock, payable in cash or publicly-traded equity at our discretion. The term of these obligations may last up to 11 years. Success payments will be owed (if applicable) after measurement of the value of our common stock in connection with the following valuation measurement dates during the term of the success payment agreement: (1) the date on which we complete an initial public offering of our common stock, or our shares otherwise become publicly traded; (2) the date on which we sell, lease, transfer or exclusively license all or substantially all of our

 

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assets to another company; (3) the date on which we merge or consolidate with or into another entity (other than a merger in which our pre-merger stockholders own a majority of the shares of the surviving entity); (4) any date on which ARCH Venture Fund VII, L.P. or C.L. Alaska L.P. transfers a majority of its shares of company capital stock held by it on such date to a third party; (5) the bi-annual anniversary of any event described in the preceding clauses (1), (2), (3) or (4), but only upon a request by FHCRC made within 20 calendar days after receiving written notice from us of such event; and (6) the last day of the 11 year period. The amount of a success payment is determined based on whether the value of our common stock meets or exceeds certain specified threshold values ascending, in the case of FHCRC, from $20.00 per share to $160.00 per share and, in the case of MSK, from $40.00 per share to $120.00 per share, in each case subject to adjustment for any stock dividend, stock split, combination of shares, or other similar events. Each threshold is associated with a success payment, ascending, in the case of FHCRC, from $10 million at $20.00 per share to $375 million at $160.00 per share and, in the case of MSK, from $10 million at $40.00 per share to $150 million at $120.00 per share, payable if such threshold is reached. The maximum aggregate amount of success payments to FHCRC is $375 million and to MSK is $150 million. The amount of success payments payable to FHCRC will be reduced by certain indirect costs paid by us to FHCRC related to collaboration projects conducted by FHCRC. See the section captioned “Licenses and Third-Party Research Collaborations” in Part I—Item 1—“Business” in our 2014 Annual Report for further discussion of these success payments.

Our initial public offering triggered a possible success payment to each of FHCRC and MSK. However, we will not be able to determine until the first anniversary of the completion of our initial public offering (subject to a 90-day grace period following such anniversary, at our option if we are contemplating a capital market transaction during such grace period), whether any such payment is required to be made and the amount of such payment. The value of any such initial public offering success payment will be determined by the average trading price of a share of our common stock over the consecutive 90-day period preceding such determination date. For example, the first payment due to FHCRC and MSK would be due if the average trading price of the share of our common stock over the consecutive 90-day period preceding the determination is at least $20.00 per share in the case of FHCRC or at least $40.00 in the case of MSK, subject to adjustment for any stock dividend, stock split, combination of shares, and other similar events. See Note 2, Acquisitions, to our unaudited financial statements included in this report for a summary of the value of success payments required to be made at different price levels.

In order to satisfy our obligations to make these success payments, if and when they are triggered, we may issue equity securities that may cause dilution to our stockholders, or we may use our existing cash or incur debt obligations to satisfy the success payment obligation in cash, which may adversely affect our financial position.

The success payment obligations to FHCRC and MSK may cause GAAP operating results to fluctuate significantly from quarter to quarter, which may reduce the usefulness of our GAAP financial statements.

Our success payment obligations to FHCRC and MSK are recorded as a liability on our balance sheet. Under generally accepted accounting principles in the United States (“GAAP”), we are required to estimate the fair value of this liability as of each quarter end and changes in estimated fair value are amortized to expense using the accelerated attribution method over the remaining term of the collaboration agreement. Factors that may lead to increases or decreases in the estimated fair value of this liability include, among others, changes in the value of the common stock, change in volatility, changes in the applicable term of the success payments, changes in the risk free rate, and changes in the estimated indirect costs related to the collaboration projects conducted by FHCRC that are creditable against FHCRC success payments. As a result, our operating results and financial condition as reported by GAAP may fluctuate significantly from quarter to quarter and from year to year and may reduce the usefulness of our GAAP financial statements. As of June 30, 2015 the estimated fair values of the liabilities associated with the success payments were $149.4 million and $62.0 million related to FHCRC and MSK, respectively.

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 debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. The incurrence of indebtedness would result in increased fixed payment obligations and could involve 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.

 

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If we, our CROs or our CMOs 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 us or third parties, such as CROs and CMOs. We and such third parties 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 and such third parties’ 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.

Our internal computer systems, or those used by our third-party research institution collaborators, CROs or other contractors or consultants, may fail or suffer security breaches.

Despite the implementation of security measures, our internal computer systems and those of our future CROs and other contractors and consultants are vulnerable to damage from computer viruses and unauthorized access. Although to our knowledge we have not experienced any such material system failure or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Likewise, we rely on our third-party research institution collaborators for research and development of our product candidates and other third parties for the manufacture of our product candidates and to conduct clinical trials, and similar events relating to their computer 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 delayed.

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

Our operations, and those of our third-party research institution collaborators, CROs, CMOs, suppliers, 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 are predominantly self-insured. In addition, we rely on our third-party research institution collaborators for conducting research and development of our product candidates, and they may be affected by government shutdowns or withdrawn funding. 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 on a patient-by-patient basis. Our ability to obtain clinical 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. Damage or extended periods of interruption to our corporate, development or research facilities due to fire, natural disaster, power loss, communications failure, unauthorized entry or other events could cause us to cease or delay development of some or all of our product candidates. Although we maintain property damage and business interruption insurance coverage, our insurance might not cover all losses under such circumstances and our business may be seriously harmed by such delays and interruption.

 

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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 clinical 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 clinical 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:

 

  decreased demand for our products;

 

  injury to our reputation;

 

  withdrawal of clinical trial participants and inability to continue clinical trials;

 

  initiation of investigations by regulators;

 

  costs to defend the related litigation;

 

  a diversion of management’s time and our resources;

 

  substantial monetary awards to trial participants or patients;

 

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

 

  loss of revenue;

 

  exhaustion of any available insurance and our capital resources;

 

  the inability to commercialize any product candidate; and

 

  a decline in our share price.

Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products we develop, alone or with collaborators. Although we currently carry $10.0 million of clinical trial insurance, the amount of such insurance coverage may not be adequate, we may be unable to maintain such insurance, or we may not be able to obtain additional or replacement insurance at a reasonable cost, if at all. Our insurance policies may also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise.

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

As of December 31, 2014, we had federal net operating loss carryforwards of approximately $51.1 million, which will begin to expire in 2033. Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally defined as a greater than 50-percentage- point cumulative change (by value) in the equity ownership of certain stockholders over a rolling three-year period), the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change taxable income or taxes may be limited. As a result of our transactions that have occurred since our incorporation in August 2013, including our initial public offering, we may have experienced such an “ownership change.” We may also experience ownership changes in the future as a result of subsequent shifts in our stock

 

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ownership, some of which changes are outside our control. As a result, our ability to use our pre-change net operating loss carryforwards and other pre-change tax attributes to offset post-change taxable income or taxes may be subject to limitation.

Risks Related to Government Regulation

The FDA regulatory approval process is lengthy, time-consuming, and inherently unpredictable, and we may experience significant delays in the clinical development and regulatory approval, if any, of our product candidates.

The research, testing, manufacturing, labeling, approval, selling, import, export, marketing, and distribution of drug products, including biologics, are subject to extensive regulation by the FDA and other regulatory authorities in the United States. We are not permitted to market any biological drug product in the United States until we receive a Biologics License from the FDA. We have not previously submitted a BLA to the FDA, or similar approval filings to comparable foreign authorities. A BLA must include extensive preclinical and clinical data and supporting information to establish that the product candidate is safe, pure, and potent for each desired indication. The BLA must also include significant information regarding the chemistry, manufacturing, and controls for the product, and the manufacturing facilities must complete a successful pre- license inspection. We expect the novel nature of our product candidates to create further challenges in obtaining regulatory approval. For example, the FDA has limited experience with commercial development of genetically modified T cell therapies for cancer. The FDA may also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to support licensure. The opinion of the Advisory Committee, although not binding, may have a significant impact on our ability to obtain licensure of the product candidates based on the completed clinical trials. Accordingly, the regulatory approval pathway for our product candidates may be uncertain, complex, expensive, and lengthy, and approval may not be obtained.

In addition, clinical trials can be delayed or terminated for a variety of reasons, including delays or failures related to:

 

  obtaining regulatory approval to begin a trial, if applicable;

 

  the availability of financial resources to begin and complete the planned trials;

 

  reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

 

  obtaining approval at each clinical trial site by an independent IRB;

 

  recruiting suitable patients to participate in a trial in a timely manner;

 

  having patients complete a trial or return for post-treatment follow-up;

 

  clinical trial sites deviating from trial protocol, not complying with cGCPs, or dropping out of a trial;

 

  addressing any patient safety concerns that arise during the course of a trial;

 

  addressing any conflicts with new or existing laws or regulations;

 

  adding new clinical trial sites; or

 

  manufacturing qualified materials under cGMPs for use in clinical trials.

Patient enrollment is a significant factor in the timing of clinical trials and is affected by many factors. See the risk factor above “—If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected” for additional information on risks related to patient enrollment. Further, a clinical trial may be suspended or terminated by us, the IRBs for the institutions in which such trials are being conducted, the Data Monitoring Committee for such trial, or the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements

 

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or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. If we experience termination of, or delays in the completion of, any clinical trial of our product candidates, the commercial prospects for our product candidates will be harmed, and our ability to generate product revenue will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue.

Our third-party research institution collaborators may also experience similar difficulties in completing ongoing clinical trials and conducting future clinical trials of product candidates. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

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

Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, but 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 of 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 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.

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 and/or to 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.

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.

If our product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post- marketing studies, and submission of safety, efficacy, and other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities.

Manufacturers and manufacturers’ facilities are required to comply with extensive FDA, and comparable foreign regulatory authority, requirements, including ensuring that quality control and manufacturing procedures conform to cGMP, and in certain cases Good Tissue Practices regulations. As such, we and our contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any BLA, other marketing application, and previous responses to inspection observations. Accordingly, we and others with whom we work must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, and quality control.

Any regulatory approvals that we receive for our product candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase IV clinical trials and surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a REMS program as a condition of approval of our product candidates, which could entail requirements for long-term patient follow-up, a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient

 

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registries and other risk minimization tools. In addition, if the FDA or a comparable foreign regulatory authority approves our product candidates, we will have to comply with requirements including 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.

The FDA may impose consent decrees or withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:

 

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

 

  fines, warning letters, or holds on clinical trials;

 

  refusal by the FDA 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 or the imposition of civil or criminal penalties.

The FDA strictly regulates marketing, labeling, advertising, and promotion of products that are placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability. The policies of the FDA and of other regulatory authorities 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.

In addition, if we were able to obtain accelerated approval of any of our CD19 product candidates, the FDA would require us to conduct a confirmatory study to verify the predicted clinical benefit and additional safety studies. The results from the confirmatory study may not support the clinical benefit, which would result in the approval being withdrawn. While operating under accelerated approval, we will be subject to certain restrictions that we would not be subject to upon receiving regular approval.

Even if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers, and others in the medical community.

The use of engineered T cells as a potential cancer treatment is a recent development and may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers, and others in the medical community. We expect physicians in the large bone marrow transplant centers to be particularly influential, and we may not be able to convince them to use our product candidates for many reasons. For example, certain of the product candidates that we will be developing target a cell surface marker that may be present on cancer cells as well as non-cancerous cells. It is possible that our product candidates may kill these non-cancerous cells, which may result in unacceptable side effects, including death. Additional factors will influence whether our product candidates are accepted in the market, including:

 

  the clinical indications for which our product candidates are approved;

 

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  physicians, hospitals, cancer treatment centers, and patients considering our product candidates as a safe and effective treatment;

 

  the potential and perceived advantages of our product candidates over alternative treatments;

 

  the prevalence and severity of any side effects;

 

  product labeling or product insert requirements of the FDA or other regulatory authorities;

 

  limitations or warnings contained in the labeling approved by the FDA;

 

  the timing of market introduction of our product candidates as well as competitive products;

 

  the cost of treatment in relation to alternative treatments;

 

  the amount of upfront costs or training required for physicians to administer our product candidates;

 

  the availability of adequate coverage, reimbursement, and pricing by third-party payors and government authorities;

 

  the willingness of patients to pay out-of-pocket in the absence of coverage and reimbursement by third-party payors and government authorities;

 

  relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and

 

  the effectiveness of our sales and marketing efforts.

In addition, although we are not utilizing embryonic stem cells or replication competent vectors, adverse publicity due to the ethical and social controversies surrounding the therapeutic use of such technologies, and reported side effects from any clinical trials using these technologies or the failure of such trials to demonstrate that these therapies are safe and effective may limit market acceptance our product candidates. If our product candidates are approved but fail to achieve market acceptance among physicians, patients, hospitals, cancer treatment centers or others in the medical community, we will not be able to generate significant revenue.

Even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or render our products obsolete.

Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates profitably.

Successful sales of our product candidates, if approved, depend on the availability of adequate coverage and reimbursement from third-party payors. In addition, because our product candidates represent new approaches to the treatment of cancer, we cannot accurately estimate the potential revenue from our product candidates.

Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors are critical to new product acceptance.

Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs and treatments they will cover and the amount of reimbursement. Coverage and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is:

 

  a covered benefit under its health plan;

 

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  safe, effective and medically necessary;

 

  appropriate for the specific patient;

 

  cost-effective; and

 

  neither experimental nor investigational.

In the United States, no uniform policy of coverage and reimbursement for products exists among third- party payors. As a result, 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 each payor supporting scientific, clinical and cost-effectiveness data for the use of our products on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained. Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Additionally, third-party payors may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of our genetically modified products. Patients are unlikely to use our product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our product candidates. Because our product candidates have a higher cost of goods than conventional therapies, and may require long- term follow up evaluations, the risk that coverage and reimbursement rates may be inadequate for us to achieve profitability may be greater.

We intend to seek approval to market our product candidates in both the United States and in selected foreign jurisdictions. If we obtain approval in one or more foreign jurisdictions for our product candidates, we will be subject to rules and regulations in those jurisdictions. In some foreign countries, particularly those in the EU, the pricing of biologics is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after obtaining marketing approval of a product candidate. In addition, market acceptance and sales of our product candidates will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for our product candidates and may be affected by existing and future health care reform measures.

Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.

Third-party payors, whether domestic or foreign, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our products profitably. In particular, in 2010, the Affordable Care Act was enacted, which, among other things, subjected biologic products to potential competition by lower-cost biosimilars, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program, extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations, subjected manufacturers to new annual fees and taxes for certain branded prescription drugs, and provided incentives to programs that increase the federal government’s comparative effectiveness research.

In addition, other legislative changes have been proposed and adopted in the United States since the Affordable Care Act was enacted. In August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers of 2% per fiscal year, which went into effect in April 2013, and will remain in effect through 2024 unless additional Congressional action is taken. In January 2013, the American Taxpayer Relief Act of 2012, was signed into law, which, among other things, further reduced Medicare payments to several providers, including hospitals and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

 

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There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

 

  the demand for our product candidates, if we obtain regulatory approval;

 

  our ability to set a price that we believe is fair for our products;

 

  our ability to generate revenue and achieve or maintain profitability;

 

  the level of taxes that we are required to pay; and

 

  the availability of capital.

Any denial in coverage or reduction in reimbursement from Medicare or other government programs may result in a similar denial or reduction in payments from private payors, which may adversely affect our future profitability.

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, misconduct or other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these parties could include intentional, reckless and negligent conduct that fails to: comply with the laws of the FDA and other similar foreign regulatory bodies; provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies; comply with manufacturing standards we have established; comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or report financial information or data accurately or to disclose unauthorized activities to us. If we obtain FDA approval of any of our product candidates and begin commercializing those products in the United States, our potential exposure under such laws will increase significantly, and our costs associated with compliance with such laws are also likely to increase. These laws may impact, among other things, our current activities with principal investigators and research patients, as well as proposed and future sales, marketing and education programs. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed 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, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials, which could result in regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter misconduct by employees and other parties, and the precautions we take to detect and prevent this activity 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 comply with these laws or 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 significant fines or other sanctions.

We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, physician payment transparency laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

If we obtain FDA approval for any of our product candidates and begin commercializing those products in the United States, our operations may be directly, or indirectly through our customers, subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, the federal False Claims Act, and physician sunshine laws and regulations. These laws may impact, among other things, our proposed sales, marketing, and education programs. In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include:

 

  the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs;

 

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  federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid, or other third-party payors that are false or fraudulent or knowingly making a false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government;

 

  the federal Health Insurance Portability and Accountability Act of 1996, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;

 

  HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization;

 

  the federal Physician Payment Sunshine Act, created under the Affordable Care Act, and its implementing regulations, which require manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the U.S. Department of Health and Human Services, information related to payments or other transfers of value made to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and

 

  federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.

Additionally, we are subject to state and foreign equivalents of each of the healthcare laws described above, among others, some of which may be broader in scope and may apply regardless of the payor.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. In addition, recent health care reform legislation has strengthened these laws. For example, the Affordable Care Act, among other things, amends the intent requirement of the federal Anti-Kickback and criminal healthcare fraud statutes. As a result of such amendment, a person or entity no longer needs to have actual knowledge of these statutes or specific intent to violate them in order to have committed a violation. Moreover, the Affordable Care Act provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

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.

 

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Risks Related to Intellectual Property

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

We are dependent on patents, know-how, and proprietary technology, both our own and licensed from others. Any termination of these licenses could result in the loss of significant rights and could harm our ability to commercialize our product candidates. See the section captioned “Licenses and Third-Party Research Collaborations” in Part I—Item 1—“Business” of our 2014 Annual Report for additional information regarding our license agreements.

Disputes may also arise between us and our licensors regarding intellectual property subject to a license agreement, including those relating 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 license agreement;

 

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

 

  whether we are complying with our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates; and

 

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

If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates. We are generally also subject to all of the same risks with respect to protection of intellectual property that we license as we are for intellectual property that we own, which are described below. If we or our licensors fail to adequately protect this intellectual property, our ability to commercialize our products could suffer.

We depend, in part, on our licensors to file, prosecute, maintain, defend, and enforce patents and patent applications that are material to our business.

Patents relating to our product candidates are controlled by certain of our licensors. Each of our licensors generally has rights to file, prosecute, maintain, and defend the patents we have licensed from such licensor. We generally have the first right to enforce our patent rights, although our ability to settle such claims often requires the consent of the licensor. If our licensors or any future licensees having rights to file, prosecute, maintain, and defend our patent rights fail to conduct these activities for patents or patent applications covering any of our product candidates, our ability to develop and commercialize those product candidates may be adversely affected and we may not be able to prevent competitors from making, using, or selling competing products. We cannot be certain that such activities by our licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents or other intellectual property rights. Pursuant to the terms of the license agreements with some of our licensors, the licensors may have the right to control enforcement of our licensed patents or defense of any claims asserting the invalidity of these patents and, even if we are permitted to pursue such enforcement or defense, we cannot ensure the cooperation of our licensors. We cannot be certain that our licensors will allocate sufficient resources or prioritize their or our enforcement of such patents or defense of such claims to protect our interests in the licensed patents. Even if we are not a party to these legal actions, an adverse outcome could harm our business because it might prevent us from continuing to license intellectual property that we may need to operate our business. In addition, even when we have the right to control patent prosecution of licensed patents and patent applications, enforcement of licensed patents, or defense of claims asserting the invalidity of those patents, we may still be adversely affected or prejudiced by actions or inactions of our licensors and their counsel that took place prior to or after our assuming control.

 

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We may not be successful in obtaining or maintaining necessary rights to product components and processes for our product development pipeline.

We own or license from third parties certain intellectual property rights necessary to develop our product candidates. The growth of our business will likely depend in part on our ability to acquire or in-license additional proprietary rights. For example, our programs may involve additional product candidates that may require the use of additional proprietary rights held by third parties. Our product candidates may also require specific formulations to work effectively and efficiently. These formulations may be covered by intellectual property rights held by others. We may be unable to acquire or in-license any relevant third-party intellectual property rights that we identify as necessary or important to our business operations. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all, which would harm our business. We may need to cease use of the compositions or methods covered by such third-party intellectual property rights, and may need to seek to develop alternative approaches that do not infringe on such intellectual property rights which may entail additional costs and development delays, even if we were able to develop such alternatives, which may not be feasible. Even if we are able to obtain a license under such intellectual property rights, any such license may be non-exclusive, which may allow our competitors access to the same technologies licensed to us.

Additionally, we sometimes collaborate with academic institutions to accelerate our preclinical research or development under written agreements with these institutions. Typically, these institutions provide us with an option to negotiate a license to any of the institution’s rights in technology resulting from the collaboration. Regardless of such option, we may be unable to negotiate a license within the specified timeframe or under terms that are acceptable to us. If we are unable to do so, the institution may offer the intellectual property rights to other parties, potentially blocking our ability to pursue our program. If we are unable to successfully obtain rights to required third-party intellectual property or to maintain the existing intellectual property rights we have, we may have to abandon development of such program and our business and financial condition could suffer.

The licensing and acquisition of third-party intellectual property rights is a competitive practice, and companies that may be more established, or have greater resources than we do, may also be pursuing strategies to license or acquire third-party intellectual property rights that we may consider necessary or attractive in order to commercialize our product candidates. More established companies may have a competitive advantage over us due to their larger size and cash resources or greater clinical development and commercialization capabilities. There can be no assurance that we will be able to successfully complete such negotiations and ultimately acquire the rights to the intellectual property surrounding the additional product candidates that we may seek to acquire.

We are dependent on intellectual property sublicensed to us by Opus Bio from the NIH for development of JCAR018. Failure to meet our own obligations to Opus Bio and the NIH may result in the loss of our rights to such intellectual property, which could harm our business.

Under our license agreement with Opus Bio, we are obligated to make certain pass-through payments to the NIH as well as to meet certain development benchmarks within certain time periods. We may be unable to make these payments or meet these benchmarks or may breach our other obligations under this license agreement, which could lead to the termination of the license agreement.

In addition, the NIH has the right to require us to grant mandatory sublicenses to the intellectual property licensed from the NIH under certain specified circumstances, including if it is necessary to meet health and safety needs that we are not reasonably satisfying or if it is necessary to meet requirements for public use specified by federal regulations. Any required sublicense of these licenses could result in the loss of significant rights and could harm our ability to commercialize licensed products.

We could be unsuccessful in obtaining or maintaining adequate patent protection for one or more of our products or product candidates.

We anticipate that we will file additional patent applications both in the United States and in other countries, as appropriate. However, we cannot predict:

 

  if and when any patents will issue;

 

  the degree and range of protection any issued patents will afford us against competitors, including whether third parties will find ways to invalidate or otherwise circumvent our patents;

 

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  whether others will apply for or obtain patents claiming aspects similar to those covered by our patents and patent applications; or

 

  whether we will need to initiate litigation or administrative proceedings to defend our patent rights, which may be costly whether we win or lose.

Composition of matter patents for biological and pharmaceutical products such as CAR or TCR product candidates are generally considered to be the strongest form of intellectual property protection for those types of products, as such patents provide protection without regard to any method of use. We cannot be certain, however, that the claims in our pending patent applications covering the composition of matter of our product candidates will be considered patentable by the United States Patent and Trademark Office (“USPTO”), or by patent offices in foreign countries, or that the claims in any of our issued patents will be considered valid and enforceable by courts in the United States or foreign countries. Method of use patents protect the use of a product for the specified method. This type of patent does not prevent a competitor from making and marketing a product that is identical to our product for an indication that is outside the scope of the patented method. Moreover, even if competitors do not actively promote their product for our targeted indications, physicians may prescribe these products “off-label” for those uses that are covered by our method of use patents. Although off-label prescriptions may infringe or contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute.

The strength of patents in the biotechnology and pharmaceutical field can be uncertain, and evaluating the scope of such patents involves complex legal and scientific analyses. The patent applications that we own or in-license may fail to result in issued patents with claims that cover our product candidates or uses thereof in the United States or in other foreign countries. Even if the patents do successfully issue, third parties may challenge the validity, enforceability, or scope thereof, which may result in such patents being narrowed, invalidated, or held unenforceable. For example, on August 13, 2015, Kite Pharma filed a petition with the USPTO for inter partes review of U.S. Patent No. 7,446,190, a patent that we have exclusively licensed from MSK. If Kite Pharma is successful in its petition and resulting proceedings at the USPTO, the patent could be narrowed or invalidated. Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property or prevent others from designing their products to avoid being covered by our claims. If the breadth or strength of protection provided by the patent applications we hold with respect to our product candidates is threatened, this could dissuade companies from collaborating with us to develop, and could threaten our ability to commercialize, our product candidates. Further, if we encounter delays in our clinical trials, the period of time during which we could market our product candidates under patent protection would be reduced. Because patent applications in the United States and most other countries are confidential for a period of time after filing, we cannot be certain that we were the first to file any patent application related to our product candidates. Furthermore, for U.S. applications in which all claims are entitled to a priority date before March 16, 2013, an interference proceeding can be provoked by a third party or instituted by the USPTO to determine who was the first to invent any of the subject matter covered by the patent claims of our applications. For U.S. applications containing a claim not entitled to priority before March 16, 2013, there is a greater level of uncertainty in the patent law in view of the passage of the America Invents Act, which brought into effect significant changes to the U.S. patent laws, including new procedures for challenging pending patent applications and issued patents.

Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of trade secrets and other proprietary information.

In addition to the protection afforded by patents, we seek to rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that we elect not to patent, processes for which patents are difficult to enforce, and any other elements of our product discovery and development processes that involve proprietary know-how, information, or technology that is not covered by patents. Trade secrets, however, may be difficult to protect. We seek to protect our proprietary processes, in part, by entering into confidentiality agreements with our employees, consultants, outside scientific advisors, contractors, and collaborators. Although we use reasonable efforts to protect our trade secrets, our employees, consultants, outside scientific advisors, contractors, and collaborators might intentionally or inadvertently disclose our trade secret information to competitors. In addition, competitors may otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, or misappropriation of our intellectual property by third parties, we will not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results, and financial condition.

 

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Third-party claims of intellectual property infringement against us or our collaborators may prevent or delay our product discovery and development efforts.

Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference, derivation, and reexamination proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions. Recently, due to changes in U.S. law referred to as patent reform, new procedures including inter partes review and post-grant review have been implemented. As stated above, this reform adds uncertainty to the possibility of challenge to our patents in the future.

Numerous U.S. and foreign issued patents and pending patent applications owned by third parties exist in the fields in which we are developing our product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our product candidates may give rise to claims of infringement of the patent rights of others.

Although we have conducted analyses of the patent landscape with respect to our CD19 product candidates, and based on these analyses, we believe that we will be able to commercialize our CD19 product candidates, third parties may nonetheless assert that we infringe their patents, or that we are otherwise employing their proprietary technology without authorization, and may sue us. For instance, Novartis Pharmaceutical Corporation has asserted in writing its belief that we infringe the following patents controlled by Novartis Pharmaceutical Corporation: U.S. Patent Nos. 7,408,053, 7,205,101, 7,527,925, and 7,442,525. There may be third-party patents of which we are currently unaware with claims to compositions, formulations, methods of manufacture, or methods of use or treatment that cover our product candidates. Because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that our product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies or the manufacture, use, or sale of our product candidates infringes upon these patents. If any such third-party patents were held by a court of competent jurisdiction to cover our technologies or product candidates, the holders of any such patents may be able to block our ability to commercialize the applicable product candidate unless we obtain a license under the applicable patents, or until such patents expire or are finally determined to be held invalid or unenforceable. Such a license may not be available on commercially reasonable terms or at all. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, our ability to commercialize our product candidates may be impaired or delayed, which could in turn significantly harm our business.

Third parties asserting their patent rights against us may seek and obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of management and other employee resources from our business, and may impact our reputation. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties, or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure. In that event, we would be unable to further develop and commercialize our product candidates, which could harm our business significantly.

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, and, in particular, some of our patents directed to CAR constructs do not extend outside of the United States. Filing, prosecuting, maintaining 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 have a different scope and strength than do those in the United States. In addition, the laws of some foreign countries, such as China, Brazil, Russia, India, and South Africa, 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 rights are not as strong as those in the United States. These products may compete with our products and our patents or other intellectual property rights may not be effective or adequate to prevent them from competing.

 

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Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, such as China, Brazil, Russia, India, and South Africa, do not favor the enforcement of patents, trade secrets and other intellectual property, particularly those relating to biopharmaceutical products, which could make it difficult in those jurisdictions for us to stop the infringement or misappropriation of our patents or other intellectual property rights, or the marketing of competing products in violation of our proprietary rights. Proceedings to enforce our patent and other intellectual property rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business. Furthermore such proceedings could put our patents at risk of being invalidated, held unenforceable, or interpreted narrowly, could put our patent applications at risk of not issuing, and could provoke third parties to assert claims of infringement or misappropriation 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.

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 cease such infringement or unauthorized use, we may be required to file patent infringement claims, which can be expensive and time- consuming. In addition, in an infringement proceeding or a declaratory judgment action against us, a court may decide that one or more of our patents is not valid or is unenforceable, or 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 proceeding 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.

Interference or derivation proceedings provoked by third parties or brought by the USPTO may be necessary to determine the priority of inventions with respect to, or the correct inventorship of, 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, interference, or derivation 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.

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.

Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or before the USPTO or comparable foreign authority.

If we or one of our licensing partners initiate legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product candidate is invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re- examination, inter partes review, post-grant review, and equivalent proceedings in foreign jurisdictions, such as opposition or derivation proceedings. Such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover and protect our product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity of our patents, for example, we cannot be certain that there is no invalidating prior art of which we, our patent counsel, and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product candidates. Such a loss of patent protection could have a material adverse impact on our business.

 

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Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.

As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involves, both technological and legal complexity, and is therefore costly, time-consuming, and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. For example, in Assoc. for Molecular Pathology v. Myriad Genetics, Inc. , the U.S. Supreme Court held that certain claims to naturally-occurring substances are not patentable. Although we do not believe that any of the patents owned or licensed by us will be found invalid based on this decision, we cannot predict how future decisions by the courts, the U.S. Congress, or the USPTO may impact the value of our patents.

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 biotechnology or pharmaceutical 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.

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.

Periodic maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment, and other similar provisions during the patent application process. Although an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, non-payment of fees, and failure to properly legalize and submit formal documents. In any such event, our competitors might be able to enter the market, which would have a material adverse effect on our business.

The lives of our patents may not be sufficient to effectively protect our products and business.

Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after its first effective filing date. Although various extensions may be available, the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired for a product, we may be open to competition from biosimilar or generic medications. Our issued patents will expire on dates ranging from 2015 to 2031, subject to any patent extensions that may be available for such patents. If patents are issued on our pending patent applications, the resulting patents are projected to expire on dates ranging from 2022 to 2036. In addition, although upon issuance in the United States a patent’s life can be increased based on certain delays caused by the USPTO, this increase can be reduced or eliminated based on certain delays caused by the patent applicant during patent prosecution. If we do not have sufficient patent life to protect our products, our business and results of operations will be adversely affected.

 

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We may face competition from biosimilars, which may have a material adverse impact on the future commercial prospects of our product candidates.

Even if we are successful in achieving regulatory approval to commercialize a product candidate faster than our competitors, we may face competition from biosimilars. In the United States, the Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway for biological products that are demonstrated to be “highly similar,” or biosimilar, to or “interchangeable” with an FDA-approved biological product. This new pathway could allow competitors to reference data from innovative biological products 12 years after the time of approval of the innovative biological product. This data exclusivity does not prevent another company from developing a product that is highly similar to the innovative product, generating its own data, and seeking approval. Data exclusivity only assures that another company cannot rely upon the data within the innovator’s application to support the biosimilar product’s approval. In his proposed budget for fiscal year 2014, President Obama proposed to cut this 12-year period of exclusivity down to seven years. He also proposed to prohibit additional periods of exclusivity due to minor changes in product formulations, a practice often referred to as “evergreening.” It is possible that Congress may take these or other measures to reduce or eliminate periods of exclusivity. The Biologics Price Competition and Innovation Act of 2009 is complex and only beginning to be interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning is subject to uncertainty. Although it is uncertain when any such processes may be fully adopted by the FDA, any such processes could have a material adverse effect on the future commercial prospects for our product candidates.

In Europe, the European Commission has granted marketing authorizations for several biosimilars pursuant to a set of general and product class-specific guidelines for biosimilar approvals issued over the past few years. In Europe, a competitor may reference data supporting approval of an innovative biological product, but will not be able to get it on the market until 10 years after the time of approval of the innovative product. This 10-year marketing exclusivity period will be extended to 11 years if, during the first eight of those 10 years, the marketing authorization holder obtains an approval for one or more new therapeutic indications that bring significant clinical benefits compared with existing therapies. In addition, companies may be developing biosimilars in other countries that could compete with our products.

If competitors are able to obtain marketing approval for biosimilars referencing our products, our products may become subject to competition from such biosimilars, with the attendant competitive pressure and consequences.

We may be subject to claims challenging the inventorship of our patents and other intellectual property.

Although we are not currently experiencing any claims challenging the inventorship of our patents or ownership of our intellectual property, we may in the future be subject to claims that former employees, collaborators, or other third parties have an interest in our patents or other intellectual property as an inventor or co-inventor. For example, we may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

Risks Related to Our Common Stock

We expect that our stock price will fluctuate significantly.

The trading price of our common stock may be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control. In addition to the factors discussed in this “Risk Factors” section and elsewhere in this report, these factors include:

 

  adverse results or delays in the planned clinical trials of our product candidates or any 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, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information;

 

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  regulatory or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our products, including clinical trial requirements for approvals;

 

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

 

  any failure to commercialize our product candidates or if the size and growth of the markets we intend to target fail to meet expectations;

 

  additions or departures of key scientific or management personnel;

 

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

 

  introductions or announcements of new products offered by us or significant acquisitions, strategic partnerships, joint ventures or capital commitments by us, our collaborators or our competitors and the timing of such introductions or announcements;

 

  announcements relating to future collaborations or our existing collaboration with Celgene, including decisions regarding the exercise by Celgene or us of any of our or their options thereunder, or any exercise or non-exercise by Celgene of a right to purchase shares of our common stock;

 

  our ability to effectively manage our growth;

 

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

 

  changes in the structure of healthcare payment systems;

 

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

 

  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;

 

  market conditions in the pharmaceutical and biotechnology sectors or the economy generally;

 

  our ability or inability to raise additional capital through the issuance of equity or debt or collaboration arrangements and the terms on which we raise it;

 

  trading volume of our common stock;

 

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

 

  significant lawsuits, including patent or stockholder litigation.

The stock market in general, and market prices for the securities of biopharmaceutical companies like ours in particular, have from time to time experienced volatility that often has been unrelated to the operating performance of the underlying companies. These broad market and industry fluctuations may adversely affect the market price of our common stock, regardless of our operating performance. In several recent situations when the market price of a stock has been volatile, holders of that stock have instituted securities class action litigation against the company that issued the stock. If any of our stockholders were to bring a lawsuit against us, the defense and disposition of the lawsuit could be costly and divert the time and attention of our management and harm our operating results.

An active trading market for our common stock may not be sustained.

Prior to our initial public offering in December 2014, there was no public market for our common stock. Although our common stock is listed on The NASDAQ Global Select Market, the market for our shares has demonstrated

 

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varying levels of trading activity. Furthermore, an active trading market may not be sustained in the future. The lack of an active market may impair investors’ ability to sell their shares at the time they wish to sell them or at a price that they consider reasonable, may reduce the market value of their shares and may impair our ability to raise capital.

If securities or industry analysts do not publish research reports about our business, or if they issue an adverse opinion about our business, our stock price and trading volume could decline.

The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about us or our business. If one or more of the analysts who cover us issues an adverse opinion about our company, our stock price would likely decline. If one or more of these analysts ceases research coverage of us or fails to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.

Future sales of our common stock in the public market could cause our stock price to fall.

Our stock price could decline as a result of sales of a large number of shares of our common stock or the perception that these sales could occur. These sales, or the possibility that these sales may occur, also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate.

As of June 30, 2015, we had 91,376,720 shares of common stock outstanding, including 6,751,850 shares of restricted stock that remained subject to vesting requirements. In connection with the sale of shares to Celgene, all 9,137,672 shares acquired by Celgene on August 4, 2015, representing 9.1% of our common stock outstanding as of the date of issuance (after giving effect to such issuance), are subject to a market standoff agreement for 364 days from the date of acquisition. Any subsequent acquisitions of shares of our common stock by Celgene will commence another 364 day market standoff period, subject to certain exceptions.

We have also registered the offer and sale of all shares of common stock that we may issue under our equity compensation plans, including upon the exercise of stock options. These shares can be freely sold in the public market upon issuance.

As of August 20, 2015, the holders of as many as 37,295,209 shares, or 40.8% of our common stock outstanding as of June 30, 2015, will have rights, subject to some conditions, under the investor rights agreement with such holders to require us to file registration statements covering the sale of their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. Once we register the offer and sale of shares for the holders of registration rights, they can be freely sold in the public market. In connection with the collaboration agreement with Celgene, we have also entered into a registration rights agreement, pursuant to which upon the written request of Celgene at certain times and subject to the satisfaction of certain conditions, we have agreed to prepare and file with the SEC a registration statement on Form S-3 for purposes of registering the resale of the shares specified in Celgene’s written request or, if we are not at such time eligible for the use of Form S-3, use commercially reasonable efforts to prepare and file a registration statement on a Form S-1 or alternative form that permits the resale of the shares.

In addition, in the future, we may issue additional shares of common stock or other equity or debt securities convertible into common stock in connection with a financing, acquisition, litigation settlement, employee arrangements or otherwise, including up to 30% of shares of our outstanding common stock to Celgene. Any such issuance could result in substantial dilution to our existing stockholders and could cause our stock price to decline.

Our principal stockholders and management own a significant percentage of our stock and will be able to exercise significant influence over matters subject to stockholder approval.

Our executive officers, directors and our 10% or greater stockholders, together with their respective affiliates, beneficially owned approximately 48.4% of our capital stock as of June 30, 2015, excluding shares underlying outstanding options. Accordingly, such persons and entities, if they acted together, would be able to determine the composition of the board of directors, retain the voting power to approve many matters requiring stockholder approval, including mergers and other business combinations, and continue to have significant influence over our operations. In addition, other than in connection with a change of control, in any vote or action by written consent of our stockholders, including, without limitation, with respect to the election of directors, Celgene has agreed to vote or execute a written consent with respect to all of our voting securities held by Celgene in accordance with the

 

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recommendation of our board of directors, limiting the ability of Celgene to contrary to our board of directors that you otherwise may believe is in your best interest as our stockholder. This concentration of ownership amongst our significant holders, including Celgene, could have the effect of delaying or preventing a change in our control or otherwise discouraging a potential acquirer from attempting to obtain control of us that you may believe are in your best interests as one of our stockholders. This in turn could have a material adverse effect on our stock price and may prevent attempts by our stockholders to replace or remove the board of directors or management.

In connection with the entry into the Celgene collaboration agreement, Celgene acquired 9.1% of our outstanding shares of common stock and subject to certain conditions, may purchase additional shares annually to obtain and maintain a 10% ownership percentage through June 29, 2020. Furthermore, between June 29, 2019 and June 29, 2025 and between June 29, 2024 and the expiration of the collaboration agreement, subject to certain conditions, Celgene has the option to acquire and maintain an ownership of up to 19.99% and up to 30%, respectively, of our then outstanding shares of common stock. We have also entered into a voting and standstill agreement with Celgene, pursuant to which we have agreed to give Celgene certain board designation rights until at least June 29, 2020, and thereafter for as long as Celgene and its affiliates beneficially own at least 7.5% of the voting power of our outstanding shares. As a result of the concentration of ownership, Celgene could have the ability to delay or prevent a change in our control or otherwise discourage a potential acquirer from attempting to obtain control of us that you may believe are in your best interests as our stockholder.

Anti-takeover provisions in our charter documents and under Delaware or Washington law could make an acquisition of us difficult, limit attempts by our stockholders to replace or remove our current management and adversely affect our stock price.

Provisions of our certificate of incorporation and bylaws may delay or discourage transactions involving an actual or potential change in our control or change in our management, including transactions in which stockholders might otherwise receive a premium for their shares, or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions could adversely affect the price of our stock. Among other things, the certificate of incorporation and bylaws will:

 

  permit the board of directors to issue up to 5,000,000 shares of preferred stock, with any rights, preferences and privileges as they may designate;

 

  provide that the authorized number of directors may be changed only by resolution of the board of directors;

 

  provide that all vacancies, including newly-created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;

 

  divide the board of directors into three classes;

 

  provide that a director may only be removed from the board of directors by the stockholders for cause;

 

  require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and may not be taken by written consent;

 

  provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner, and meet specific requirements as to the form and content of a stockholder’s notice;

 

  prevent cumulative voting rights (therefore allowing the holders of a plurality of the shares of common stock entitled to vote in any election of directors to elect all of the directors standing for election, if they should so choose);

 

  require that, to the fullest extent permitted by law, a stockholder reimburse us for all fees, costs and expenses incurred by us in connection with a proceeding initiated by such stockholder in which such stockholder does not obtain a judgment on the merits that substantially achieves the full remedy sought;

 

  provide that special meetings of our stockholders may be called only by the chairman of the board, our chief executive officer (or president, in the absence of a chief executive officer) or by the board of directors; and

 

  provide that stockholders will be permitted to amend the bylaws only upon receiving at least two- thirds of the total votes entitled to be cast by holders of all outstanding shares then entitled to vote generally in the election of directors, voting together as a single class.

 

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Furthermore, pursuant to the voting and standstill agreement with Celgene, until the later of the fifth anniversary of the date of such agreement and the expiration or earlier termination of our collaboration agreement with Celgene, it will be bound by certain “standstill” provisions which generally will prevent it from purchasing outstanding shares of our common stock, making a tender offer or encouraging or supporting a third party tender offer, nominating a director whose nomination has not been approved by our board of directors, soliciting proxies in opposition to the recommendation of our board of directors or assisting a third party in taking such actions, entering into discussions with a third party as to such actions, or requesting or proposing in writing to our board of directors or any member thereof that we amend or waive any of these limitations. As a result, the ability of Celgene to act in contrary to our board of directors is severely limited and any attempts by Celgene to acquire us or encourage a third party to acquire us are prohibited by this voting and standstill agreement. In addition, subject to certain exceptions—including a vote in connection with a change in control of our company—Celgene has agreed to vote or execute a written consent with respect to all of our voting securities held by Celgene in accordance with the recommendation of our board of directors, limiting the ability of Celgene to contrary to our board of directors that you otherwise may believe is in your best interest as our stockholder.

In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which generally prohibits a Delaware corporation from engaging in any of a broad range of business combinations with any “interested” stockholder for a period of three years following the date on which the stockholder became an “interested” stockholder. Likewise, because our principal executive offices are located in Washington, the anti-takeover provisions of the Washington Business Corporation Act may apply to us under certain circumstances now or in the future. These provisions prohibit a “target corporation” from engaging in any of a broad range of business combinations with any stockholder constituting an “acquiring person” for a period of five years following the date on which the stockholder became an “acquiring person.”

Our certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for any derivative action or proceeding brought on our behalf, any action asserting a breach of fiduciary duty, any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws, any action to interpret, apply, enforce, or determine the validity of our certificate of incorporation or bylaws, or any action asserting a claim against us that is governed by the internal affairs doctrine. The choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and other employees. Alternatively, if a court were to find the choice of forum provision contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect our business and financial condition.

Complying with the laws and regulations affecting public companies has increased and will increase our costs and the demands on management and could harm our operating results.

As a public company, we will continue to incur significant legal, accounting and other expenses that we did not incur as a private company, including costs associated with public company reporting requirements. We also anticipate that we will incur costs associated with relatively recently adopted corporate governance requirements, including requirements of the SEC and NASDAQ. We expect these rules and regulations to increase our legal and financial compliance costs and to make some activities more time-consuming and costly. We also expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified individuals to serve on our board of directors or as executive officers. We are currently evaluating and monitoring developments with respect to these rules, and we cannot predict or estimate the amount of additional costs we may incur or the timing of such costs.

 

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Starting January 1, 2016, we will no longer be an “emerging growth company” and after that date we will no longer be able to avail ourselves of exemptions from various reporting requirements applicable to other public companies but not to “emerging growth companies.” For example, the Sarbanes-Oxley Act requires, among other things, that we assess the effectiveness of our internal control over financial reporting annually and the effectiveness of our disclosure controls and procedures quarterly. Section 404 of the Sarbanes-Oxley Act (“Section 404”) requires us to perform system and process evaluation and testing of our internal control over financial reporting to allow management to report on, and our independent registered public accounting firm potentially to attest to, the effectiveness of our internal control over financial reporting. We are currently an “emerging growth company,” and have availed ourselves of the exemption from the requirement that our independent registered public accounting firm attest to the effectiveness of our internal control over financial reporting under Section 404. However, beginning on January 1, 2016, we will no longer avail ourselves of this exemption when we cease to be an “emerging growth company.” When our independent registered public accounting firm is required to undertake an assessment of our internal control over financial reporting, the cost of our compliance with Section 404 will correspondingly increase. Our compliance with applicable provisions of Section 404 will require that we incur substantial accounting expense and expend significant management time on compliance-related issues as we implement additional corporate governance practices and comply with reporting requirements. Moreover, if we are not able to comply with the requirements of Section 404 applicable to us in a timely manner, or if we or our independent registered public accounting firm identifies deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, the market price of our stock could decline and we could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources. Furthermore, investor perceptions of our company may suffer if deficiencies are found, and this could cause a decline in the market price of our stock. Irrespective of compliance with Section 404, any failure of our internal control over financial reporting could have a material adverse effect on our stated operating results and harm our reputation. If we are unable to implement these requirements effectively or efficiently, it could harm our operations, financial reporting, or financial results and could result in an adverse opinion on our internal control over financial reporting from our independent registered public accounting firm.

Our management team has broad discretion to use the net proceeds from the initial payments to us under our collaboration agreement with Celgene and from the sale of our shares to Celgene and its investment of these proceeds may not yield a favorable return. We may invest the proceeds of the Celgene transaction and any remaining proceeds from our initial public offering in December 2014 in ways with which investors disagree.

Our management has broad discretion over the use of proceeds from the initial payments to us under our collaboration agreement with Celgene and from the sale of our shares to Celgene, as well as any remaining proceeds from our December 2014 initial public offering, and we could spend the proceeds from these transactions in ways our stockholders may not agree with or that do not yield a favorable return, if at all. In addition, until the proceeds are used, they may be placed in investments that do not produce significant income or that may lose value. If we do not invest or apply the proceeds in ways that improve our operating results, we may fail to achieve expected financial results, which could cause our stock price to decline.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

(a)

Not applicable.

(b)

On December 23, 2014, we closed our IPO, in which we sold an aggregate of 12,676,354 shares of common stock at a price to the public of $24.00 per share. The offer and sale of all of the shares in the initial public offering were registered under the Securities Act pursuant to a registration statement on Form S-1 (File No. 333-200293), which was declared effective by the SEC on December 18, 2014 (the “Registration Statement”), and a registration statement on Form S-1 (File No. 333-201062), which became effective immediately upon filing with the SEC on December 18, 2014.

There has been no material change in the planned use of proceeds from our IPO as described in the Registration Statement. We invested the funds received in short-term, interest-bearing investment-grade securities and government securities. As of June 30, 2015, we have used approximately $155.4 million of the net proceeds from the IPO primarily to fund the costs to advance JCAR015 through a Phase II clinical trial and the filing of a Biologics

 

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License Application for the treatment of relapsed/refractory ALL, to advance JCAR017 through a Phase I/II clinical trial and into a potential registration trial in relapsed/refractory NHL, to further develop additional product candidates, to expand our internal research and development capabilities, to establish manufacturing capabilities, to acquire, license and invest in complementary products, technologies and businesses, and other general corporate purposes. None of the offering proceeds were paid directly or indirectly to any of our directors or officers (or their associates) or persons owning 10.0% or more of any class of our equity securities or to any other affiliates.

(c)

Not applicable.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

Not applicable.

 

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

 

ITEM 5. OTHER INFORMATION

(a)

Not applicable.

(b)

Not applicable.

 

ITEM 6. EXHIBITS

See the Exhibit Index on the page immediately following the signature page to this Quarterly Report on Form 10-Q for a list of the exhibits filed as part of this Quarterly Report, which Exhibit Index is incorporated herein by reference.

 

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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.

 

    Juno Therapeutics, Inc.
Date: August 14, 2015     By:  

/s/    Steven D. Harr        

     

Steven D. Harr

Chief Financial Officer &
Head of Corporate Development

(principal financial and accounting officer)

 

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EXHIBIT INDEX

 

Exhibit

Number

       

Incorporated by Reference

  

Filed

Herewith

 
    

Exhibit Description

  

Form

  

Date

  

Number

      
    2.1#‡ D    Share Purchase Agreement, dated May 11, 2015, by and among Dr. Herbert Stadler, Dr. Lothar Germeroth, Prof. Dr. Dirk Busch, and the registrant    8-K    05/11/2015    2.1   
    2.2#‡ D    Agreement and Plan of Merger, dated June 1, 2015, by and among X Acquisition Corporation, X-Body, Inc., Brant Binder as stockholder representative, certain principal stockholders of X-Body, Inc., and the registrant    8-K    06/05/2015    2.1   
    3.1    Amended and Restated Certificate of Incorporation    8-K    12/29/2014    3.1   
    3.2    Amended and Restated Bylaws    S-1/A    12/09/2014    3.2   
    4.1    Fourth Amended and Restated Investors’ Rights Agreement, dated December 5, 2014, by and among the registrant and the investors named therein    S-1/A    12/09/2014    4.1   
    4.2    Amendment and Waiver of Fourth Amended and Restated Investors’ Rights Agreement, dated July 27, 2015               X   
    4.3    Form of Common Stock Certificate    S-1/A    12/09/2014    4.2   
  10.1+    Amendment #2 to License Agreement, dated April 4, 2015, by and between St. Jude Children’s Research Hospital, Inc. and the registrant               X   
  10.2+    Non-Exclusive Sublicense Agreement, effective April 7, 2015, by and among Novartis Institutes for Biomedical Research, Inc., The Trustees of the University of Pennsylvania, and the registrant               X   
  10.3    Lease Agreement, dated as of April 6, 2015, by and between ARE-Seattle No. 16, LLC and the registrant    8-K    04/07/2015    10.1   
  10.4    First Amendment to Lease Agreement, dated May 21, 2015, by and between ARE-Seattle No. 16, LLC and the registrant               X   
  10.5    2015 Non-Employee Director Compensation Program, adopted April 3, 2015    10-Q    05/12/2015    10.3   
  10.6    Amendment No. 1 to Sponsored Research Agreement, effective April 1, 2015, by and between Seattle Children’s Hospital d/b/a Seattle Children’s Research Institute and the registrant    10-Q    05/12/2015    10.4   
  10.7+    Amendment No. 2 to Exclusive License Agreement, dated June 15, 2015, by and between Seattle Children’s Hospital d/b/a Seattle Children’s Research Institute and the registrant               X   
  10.8    Offer Letter with Hyam Levitsky, dated May 27, 2015               X   
  10.9+‡    Share Purchase Agreement, dated June 29, 2015, by and among Celgene Corporation, Celgene RIVOT Ltd., and the registrant    8-K    06/29/2015    10.1   
  10.10    Voting and Standstill Agreement, dated June 29, 2015, by and among Celgene Corporation, Celgene RIVOT Ltd., and the registrant    8-K    06/29/2015    10.2   
  10.11    Registration Rights Agreement, dated June 29, 2015, by and among Celgene Corporation, Celgene RIVOT Ltd., and the registrant    8-K    06/29/2015    10.3   

 

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  10.12+    Amended and Restated Master Research and Collaboration Agreement, dated August 13, 2015, by and among Celgene Corporation, Celgene RIVOT Ltd., and the registrant                                                                       X   
  10.13    First Amendment to Lease, dated July 31, 2015, by and between BMR-217 th Place LLC and the registrant               X   
  31.1    Certification of Principal Executive Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended               X   
  31.2    Certification of Principal Financial Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended               X   
  32.1*    Certification of Principal Executive Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. §1350               X   
  32.2*    Certification of Principal Financial Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. §1350               X   
101†    The following materials from Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, formatted in eXtensible Business Reporting Language (XBRL) includes: (i) Condensed Consolidated Balance Sheets at June 30, 2015 (unaudited) and December 31, 2014, (ii) Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) for the three and six months ended June 30, 2015 and 2014, (iii) Condensed Consolidated Statements of Cash Flows (unaudited) for the six months ended June 30, 2015 and 2014, and (iv) Notes to the Condensed Consolidated Financial Statements.               X   

 

* The certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Juno Therapeutics, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-K, irrespective of any general incorporation language contained in such filing.
XBRL information is furnished and not filed or a part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Exchange Act of 1933, as amended, is deemed not filed for purposes of section 18 of the Securities Exchange Act of 1934, as amended, and otherwise is not subject to liability under these sections.
+ Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment and this exhibit has been filed separately with the Securities and Exchange Commission.
# Confidential treatment has been granted for certain information contained in this exhibit. Such information has been omitted and filed separately with the Securities and Exchange Commission.
The representations and warranties contained in this agreement were made only for purposes of the transactions contemplated by the agreement as of specific dates and may have been qualified by certain disclosures between the parties and a contractual standard of materiality different from those generally applicable under securities laws, among other limitations. The representations and warranties were made for purposes of allocating contractual risk between the parties to the agreement and should not be relied upon as a disclosure of factual information about the registrant or the transactions contemplated thereby.
D The exhibits and schedules to this agreement have been omitted in reliance on Item 601(b)(2) of Regulation S-K promulgated by the Securities and Exchange Commission, and a copy thereof will be furnished supplementally to the Securities and Exchange Commission upon its request.

 

95

Exhibit 4.2

AMENDMENT AND WAIVER

OF

FOURTH AMENDED AND RESTATED

INVESTORS’ RIGHTS AGREEMENT

OF JUNO THERAPEUTICS, INC.

July 27, 2015

This Amendment and Waiver dated as of July 27, 2015 (the “ Amendment and Waiver ”) amends and waives certain provisions of that certain Fourth Amended and Restated Investors’ Rights Agreement dated as of December 5, 2014 (the “ Agreement ”), between Juno Therapeutics, Inc., a Delaware corporation (the “ Company ”), and the Investors named therein. Capitalized terms used herein without definition shall have the meanings given in the Agreement.

RECITALS

A. The Agreement provides, among other things, for certain registration rights granted by the Company to the Investors.

B. One June 29, 2015, the Company entered into a Registration Rights Agreement (the “ Celgene Agreement ”) with Celgene Corporation and Celgene RIVOT Ltd (together, “ Celgene ”) granting certain registration rights to Celgene.

C. The Celgene Agreement provides that the registration rights granted to Celgene are subject to the prior, senior right of the Investors under the Agreement until such time as the Company obtains a waiver from the Investors under the Agreement.

D. Under Section 6.1 of the Agreement, the Company and the holders of at least a majority of the Registrable Securities issued upon conversion of the Company’s preferred stock, voting together as a single class, may amend or waive any term of the Agreement.

E. The Company and the Investors party hereto desire to amend and waive the Agreement to allow Celgene to exercise its registration rights under the Celgene Agreement without being subject to the rights of the Investors under the Agreement.

AMENDMENT AND WAIVER

For good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Investors party hereto, voting together as a single class in accordance with Section 6.1 of the Agreement, hereby amend and waive the Agreement on behalf of all Investors thereunder as follows:


1. The registration rights granted to Celgene under the Celgene Agreement shall not be subject to the rights of the Investors under Section 2.2 of the Agreement, except that Celgene’s rights under Section 6(f) of the Celgene Agreement shall remain subject to the rights of the Investors under the Agreement such that Celgene’s exercise of its rights under Section 6(f) of the Celgene Agreement shall not reduce the amount of securities to be registered on the associated registration statement by the Investors pursuant to registration rights provided under the Agreement.

2. Without limiting the generality of the foregoing, Celgene and its permitted transferees and assigns may exercise its registration rights under the Celgene Agreement (other than those in Section 6(f) of the Celgene Agreement) without being subject to the notice or inclusion requirements under Section 2.2(a) of the Agreement or the underwriters’ cutback provision under Section 2.2(b) of the Agreement.

3. The application of Section 2.12 of the Agreement is hereby waived with respect to the Celgene Agreement and the rights granted thereunder.

4. Nothing herein shall derogate from any rights of the Investors under the Agreement, including without limitation their right to request registration of their Registrable Securities under the Agreement, except to the extent set forth in the limited amendment and waiver above. The Agreement as amended hereby shall continue in full force and effect from and after the date hereof.

(signature page follows)


The parties are signing this Amendment and Waiver as of the date stated in the introductory clause.

 

JUNO THERAPEUTICS, INC.
a Delaware corporation
By:  

/s/ Hans Bishop

Name:   Hans Bishop
Title:   President & CEO

(Signature page to the Amendment and Waiver)


The parties are signing this Amendment and Waiver as of the date stated in the introductory clause.

 

INVESTOR:
ARCH Venture Fund VII, L.P.
By:   ARCH Venture Partners VII, L.P.
Its:   General Partner
By:   ARCH Venture Partners VII, LLC
Its:   General Partner
By:  

/s/ Robert T. Nelsen

Name:  

 

Title:  

 

(Signature page to the Amendment and Waiver)


The parties are signing this Amendment and Waiver as of the date stated in the introductory clause.

 

INVESTOR:
CL ALASKA L.P.
By:   Crestline SI (GP), L.P.
Its:   General Partner
By:  

/s/ John Cochran

Name:   John Cochran
Title:   Vice President

(Signature page to the Amendment and Waiver)

Exhibit 10.1

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

AMENDMENT #2 TO LICENSE AGREEMENT

ST. JUDE File No.: SF-03-0018

THIS AMENDMENT #2 TO LICENSE AGREEMENT (together with any exhibits attached hereto, “AMENDMENT #2”) is entered into as of April 4, 2015 (the “AMENDMENT #2 EFFECTIVE DATE”) by and between ST. JUDE CHILDREN’S RESEARCH HOSPITAL, INC., a Tennessee not-for-profit corporation having an address at 262 Danny Thomas Place, Memphis, TN 38105 (“ST. JUDE” or “LICENSOR”), and JUNO THERAPEUTICS, INC., a Delaware corporation, having an address at 307 Westlake Avenue North, Suite 300, Seattle, WA 98109 (“COMPANY”) (ST. JUDE and COMPANY hereinafter each referred to as a “PARTY”, or collectively referred to as the “PARTIES”) with respect to the following:

RECITALS

WHEREAS, LICENSOR and COMPANY are parties to the Exclusive License Agreement, effective as of December 3, 2013, as amended by Amendment #1 to Exclusive License Agreement, effective as of February 20, 2014, which Amendment #1 is attached hereto as Annex A (together, the “AGREEMENT”) which set forth certain rights and obligations of both Parties relating to certain valuable inventions and PATENT RIGHTS relating to such valuable inventions; and

WHEREAS, COMPANY and LICENSOR have been parties to certain litigation, The Trustees of the University of Pennsylvania v. St. Jude Children’s Research Hospital, Inc. , Civil Action No. 2:13-cv-01502-SD; Trustees of the University of Pennsylvania v. St. Jude’s Children’s Research Hospital , Civil Action No. 2:12-cv-04122-SD; and St. Jude Children’s Research Hospital v. Trustees of the University of Pennsylvania , Civil Action No. 2:12-cv-05878-SD, pending before the United States District Court, Eastern District of Pennsylvania (collectively, the “ Litigation ”); and

WHEREAS, LICENSOR and COMPANY desire to revise and amend the AGREEMENT to fully effect and perfect the terms of settlement of the Litigation and the grant of a sublicense as part of such settlement, and to avoid inconsistencies between the terms of this AGREEMENT and the terms of such sublicense.

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

AGREEMENT

1. Capitalized Terms . Capitalized terms used herein but not defined herein shall have the definitions set forth in the AGREEMENT.


2. Amendment of Article 1 (DEFINITIONS) . The Parties hereby agree to amend Article 1 (DEFINITIONS) of the AGREEMENT as follows:

2.1 Section 1.5 “LICENSED PRODUCT(S)” is hereby amended to include at the end the following:

Notwithstanding the foregoing, LICENSED PRODUCT(S) shall mean, when used in relation to NOVARTIS SUBLICENSE AGREEMENT, any material, cell, composition or drug, the manufacture, use, importation, offer for sale or sale of which would infringe any VALID CLAIM but for the license granted under the NOVARTIS SUBLICENSE AGREEMENT. For the avoidance of doubt, as of the NOVARTIS SUBLICENSE AGREEMENT EFFECTIVE DATE (i.e., as the PATENT RIGHTS and VALID CLAIMS thereunder exist as of the NOVARTIS SUBLICENSE AGREEMENT EFFECTIVE DATE), [***] are LICENSED PRODUCTS.

2.2 Section 1.6 “LICENSED SERVICES” is hereby amended to include at the end the following:

Notwithstanding the foregoing, LICENSED SERVICES shall mean, when used in relation to the NOVARTIS SUBLICENSE AGREEMENT, any service using a LICENSED PRODUCT, the performance of which would infringe a VALID CLAIM but for the license granted under the NOVARTIS SUBLICENSE AGREEMENT.

2.3 Section 1.7 “NET SALES” is hereby amended to include at the end the following:

Notwithstanding the foregoing, “NET SALES” shall mean, with respect to any matter relating to the NOVARTIS SUBLICENSE AGREEMENT, the net sales in the United States of America recorded by NOVARTIS or any of its AFFILIATES or PERMITTED SUBLICENSEES for sale of any LICENSED PRODUCT to, and performance of any LICENSED SERVICE for, a THIRD PARTY other than a PERMITTED SUBLICENSEE, distributor and wholesaler, as determined in accordance with [***]. The deductions booked on an accrual basis by NOVARTIS, its AFFILIATES and its PERMITTED SUBLICENSEES under NOVARTIS ACCOUNTING STANDARDS, to calculate the recorded net sales from gross sales include the following, in each case, to the extent actually accrued, discounted or credited, as applicable, and without duplication:

(i) customary trade and cash discounts;

(ii) amounts repaid or credited by reasons of defects, rejections or recalls or returns;

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(iii) [***];

(iv) [***];

(v) [***];

(vi) [***];

(vii) [***]; and

(viii) other reductions for specifically identifiable amounts deducted for reasons substantially similar to those listed in clauses (i) through (vii) above if [***].

With respect to the calculation of NET SALES:

(A) [***]; and

(B) If a LICENSED PRODUCT is delivered to the THIRD PARTY before being invoiced (or is not invoiced), NET SALES will be calculated [***].

2.4 Section 1.8 “PATENT RIGHTS” is hereby amended to include at the end the following:

Notwithstanding the foregoing, PATENT RIGHTS, when used in relation to the NOVARTIS SUBLICENSE AGREEMENT, shall mean (a) the patent and patent applications listed on Exhibit 1.13 of the NOVARTIS SUBLICENSE AGREEMENT; (b) any other patent or patent application that is a divisional, continuation, reissue, renewal, reexamination, substitution or extension of any patent or patent application identified in (a); (c) any patents subsequently issuing on any patent application identified in (a) or (b), including any reissues, renewals, reexaminations, substitutions or extensions thereof; and (d) those claims of a continuation-in-part application or patent (including any reissues, renewals, reexaminations, substitutions or extensions thereof) that are entitled to

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

3


the priority date of at least one of the patents or patent applications identified in (a), (b) or (c). Specifically excluded from PATENT RIGHTS are U.S. Patent Nos. [***] and [***], and any other patent or patent application that claims priority to, or common priority with, or is a divisional, continuation, re-issue, renewal, reexamination, substitution or extension of any patent or patent application identified in clause (a) above that contains only claims directed to the [***].

2.5 Section 1.15 “VALID CLAIM” is hereby amended to include at the end the following:

Notwithstanding the foregoing, VALID CLAIM shall mean, when used in relation to the NOVARTIS SUBLICENSE AGREEMENT, in either singular or plural, a claim of any issued and unexpired patent included within the PATENT RIGHTS and (a) such claim has not been held permanently revoked, unenforceable or invalid by the final, un-reversed, and un-appealable, or unappealed within the time allowed for appeal, decision of a court or other government body of competent jurisdiction, has been irretrievably abandoned or disclaimed, and (b) such claim has not otherwise been finally admitted or determined to be invalid, unpatentable or unenforceable, whether through reissue, reexamination, disclaimer or otherwise. A pending claim of a patent application within the PATENT RIGHTS which has been pending for a period of [***] after filing shall also constitute a VALID CLAIM if (i) the claim continues to be prosecuted in good faith and has not been cancelled, withdrawn, abandoned or finally disallowed without the possibility of appeal or re-filing of such application, and (ii) there exists an issued VALID CLAIM for which the provisions of (a) and (b) are satisfied.

2.6 A new Section 1.16 is hereby added to the AGREEMENT as follows:

1.16 “AFFILIATE” shall have the same meaning as set forth in Section 1.01 of the NOVARTIS SUBLICENSE AGREEMENT.

2.7 A new Section 1.17 is hereby added to the AGREEMENT as follows:

1.17 “NOVARTIS SUBLICENSE AGREEMENT” shall mean that certain Non-Exclusive Sublicense Agreement by and between COMPANY, NOVARTIS and PENN, a copy of which is attached here to as Exhibit G.

2.8 A new Section 1.18 is hereby added to the AGREEMENT as follows:

1.18 “NOVARTIS SUBLICENSE AGREEMENT EFFECTIVE DATE” shall mean the effective date of the NOVARTIS SUBLICENSE AGREEMENT.

2.9 A new Section 1.19 is hereby added to the AGREEMENT as follows:

1.19 “NOVARTIS” shall have the same meaning as set forth in the NOVARTIS SUBLICENSE AGREEMENT.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

4


2.10 A new Section 1.20 is hereby added to the AGREEMENT as follows:

1.20 “NOVARTIS ACCOUNTING STANDARDS” shall have the same meaning as set forth in Section 1.17 of the NOVARTIS SUBLICENSE AGREEMENT.

2.11 A new Section 1.21 is hereby added to the AGREEMENT as follows:

1.21 “PERMITTED SUBLICENSEE” shall have the same meaning as set forth in Section 1.21 of the NOVARTIS SUBLICENSE AGREEMENT.

2.12 A new Section 1.22 is hereby added to the AGREEMENT as follows:

1.22 “PENN” shall have the same meaning as set forth in the NOVARTIS SUBLICENSE AGREEMENT.

2.13 A new Section 1.23 is hereby added to the AGREEMENT as follows:

1.23 “PENN CONSTRUCT” shall have the meaning set forth in Section 1.19 of the NOVARTIS SUBLICENSE AGREEMENT.

2.14 A new Section 1.24 is hereby added to the AGREEMENT as follows:

1.24 “THIRD PARTY” shall have the meaning set forth in Section 1.31 of the NOVARTIS SUBLICENSE AGREEMENT.

3. Amendment of Article 2 (LICENSE GRANT) . The Parties hereby agree to amend Article 2 (LICENSE GRANT) of the AGREEMENT as follows:

3.1 Section 2.2 is hereby amended and replaced in its entirety as follows:

2.2 Sublicense. COMPANY may grant SUBLICENSES under the PATENT RIGHTS to third parties pursuant to this AGREEMENT, subject to the terms and conditions of this Paragraph 2.2. COMPANY shall provide LICENSOR with an unredacted copy of each SUBLICENSE between COMPANY and a third party for the grant of rights under the PATENT RIGHTS within thirty (30) days of its execution. Each SUBLICENSE shall: (a) be consistent with the terms, conditions and limitations of this AGREEMENT, (b) name LICENSOR as an intended third party beneficiary of the obligations of SUBLICENSEE without imposition of obligation or liability on the part of LICENSOR or the INVENTORS to the SUBLICENSEE, (c) shall be in writing and shall expressly set forth all rights in PATENT RIGHTS conveyed or to be conveyed to a SUBLICENSEE and all consideration received or to be received by or on behalf of COMPANY in respect of the conveyance of such rights and (d) [***]. LICENSOR acknowledges and agrees that notwithstanding anything to the contrary in the NOVARTIS SUBLICENSE AGREEMENT, the NOVARTIS SUBLICENSE AGREEMENT satisfies each of the requirements set forth in the previous sentence, as further set forth in this AMENDMENT #2; provided, however, this acknowledgement and agreement shall not be construed to affect the obligation of COMPANY to indemnify the ST. JUDE

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

5


INDEMNITEES pursuant to the AGREEMENT or otherwise be read in derogation of the rights of the ST. JUDE INDEMNITEES to be indemnified thereunder. Each SUBLICENSE furnished to LICENSOR by COMPANY shall be the Confidential Information of COMPANY. COMPANY shall (i) be and remain responsible for the performance by such SUBLICENSEE with the terms of this AGREEMENT, and any action by a SUBLICENSEE that would, if conducted by COMPANY be a breach of this AGREEMENT, shall be deemed a breach of this AGREEMENT by COMPANY, and (ii) ascertain, calculate, audit and collect all royalties that become payable by such SUBLICENSEE hereunder and take appropriate enforcement action against such SUBLICENSEE for any failure to pay or to properly calculate payments. LICENSOR shall not exercise any of its rights as a third party beneficiary granted to it pursuant to clause (b) above unless: (w) LICENSOR has notified COMPANY in writing of the obligation of SUBLICENSEE sought to be enforced (the “Obligation”); (x) the Obligation has as its origin a requirement of this AGREEMENT; (y) COMPANY has failed to commence and continue to pursue reasonable steps within thirty (30) days of notice from LICENSOR pursuant to clause (w) above to enforce the Obligation or SUBLICENSEE has not fulfilled the Obligation within ninety (90) days of notice to COMPANY pursuant to clause (w) above, and (z) at the time LICENSOR asserts its rights as a third party beneficiary against SUBLICENSEE, LICENSOR shall have a reasonable basis for believing that SUBLICENSEE is in breach of the Obligation sought to be enforced.

4. Amendment of Article 3 (FEES, ROYALTIES, & PAYMENTS) . The Parties hereby agree to amend Article 3 (FEES, ROYALTIES, & PAYMENTS) of the AGREEMENT as follows:

4.1 The first paragraph, and only the first paragraph, of Section 3.3 is hereby amended and replaced in its entirety as follows:

3.3 Running Royalties. COMPANY shall pay to LICENSOR a running royalty as set forth in Exhibit B , for LICENSED PRODUCT(S) and LICENSED SERVICE sold by COMPANY, AFFILIATED COMPANIES and/or SUBLICENSEE(S), based on NET SALES for the Term of this AGREEMENT. Such payments shall be due semi-annually (June 30th and December 31) and shall be payable within [***] of the end of each half year. Such royalties shall [***] related to LICENSED PRODUCTS and LICENSED SERVICES.

4.2 Section 3.4 is hereby amended and replaced in its entirety as follows:

3.4 Sublicense Consideration . In addition to the running royalty as set forth under Paragraph 3.3, COMPANY shall pay to LICENSOR, as set forth on Exhibit B a percentage of SUBLICENSE CONSIDERATION. Any SUBLICENSE CONSIDERATION payment due to LICENSOR shall be due within [***] of the end of the six (6) month calendar period in which any SUBLICENSE

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

6


CONSIDERATION was received, [***]. Such payment shall be accompanied by a detailed written report specifically referring to the SUBLICENSE under which COMPANY received SUBLICENSE CONSIDERATION and the total SUBLICENSE CONSIDERATION received by COMPANY during such six (6) month calendar period. COMPANY shall not directly or indirectly accept [***].

4.3 Section 3.9 is hereby amended and replaced in its entirety as follows:

3.9 Withholding Taxes. Notwithstanding that LICENSOR is a tax-exempt entity under the United States Internal Revenue Code, as amended, in the event that payments due to LICENSOR in respect of NET SALES in jurisdictions other than the United States are subject to required withholding, such taxes shall be deducted by COMPANY (or its SUBLICENSEES) from such payment prior to remittance, and shall be paid over to the relevant taxing authorities when due. COMPANY shall promptly furnish LICENSOR evidence of any such taxes withheld and of payment thereof, and shall render reasonable assistance to LICENSOR in connection with its invocation of available procedures to seek refund of such payments.

5. Amendment of Article 5 (OBLIGATIONS OF THE PARTIES) . The Parties hereby agree to amend Article 5 (OBLIGATIONS OF THE PARTIES) of the AGREEMENT as follows:

5.1 Section 5.1(a) is hereby amended and replaced in its entirety as follows:

(a) COMPANY shall provide semi-annual royalty reports, substantially in the format of Exhibit D , or as may be otherwise agreed by the parties in writing and due within [***] after the end of each calendar half year following the first commercial sale of a LICENSED PRODUCT. Royalty Reports shall disclose the amount of [***]. Payment of any such royalties due shall accompany such Royalty Reports

5.2 Section 5.1(b) is hereby amended and replaced in its entirety as follows:

(b) Until such time as COMPANY, an AFFILIATED COMPANY or a SUBLICENSEE(S) has achieved a first commercial sale of a LICENSED PRODUCT, or received FDA market approval, COMPANY shall provide annual diligence reports, due within [***] of the end of every December following the EFFECTIVE DATE of this AGREEMENT. These diligence reports shall describe COMPANY’s, AFFILIATED COMPANY’s or any SUBLICENSEE(S)’s, technical and other efforts towards meeting its obligations under the terms of this AGREEMENT, particularly its progress toward achieving the developmental milestones set forth in Exhibit C and shall explain any delays experienced in achieving such milestones relative to the projected dates for achievement set forth in Exhibit C ; provided, however, in the case of NOVARTIS and its AFFILIATES such information shall be limited to that known to COMPANY in the public domain.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

7


5.3 Section 5.1(c)(i) is hereby amended and replaced in its entirety as follows:

(i) [***]; and

5.4 Section 5.1(c)(iv) is hereby amended and replaced in its entirety as follows:

(iv) [***]; and

5.5 Section 5.1(c)(iv) is hereby amended and replaced in its entirety as follows:

(v) [***].

5.6 Section 5.2 is hereby amended and replaced in its entirety as follows:

5.2 Records. COMPANY shall keep and maintain true and accurate records, files and books of account of all sales of all Licensed Products in the Territory for at least [***] after the calendar half year in which such Net Sales are made, in sufficient detail required for the full computation and verification of sales and other information required in Paragraph 5.1(a). Such books and records shall be in accordance with generally accepted accounting principles consistently applied, provided that with respect to NOVARTIS and its AFFILIATES, such books and records shall be [***]. COMPANY shall permit the inspection of such records, files and books of account by LICENSOR’S agent (the “Auditor”), which Auditor shall be an independent, nationally recognized certified public accountant acceptable to COMPANY, such acceptance not to be unreasonably withheld, and subject to obligations of confidentiality and nonuse owed to LICENSOR consistent with the confidentiality and non-use obligations set faith in this

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

8


AGREEMENT. Any such inspection shall occur during regular business hours upon [***] written notice to COMPANY. Such inspection shall not be made more than once in a twelve (12) month period. All costs of such inspection shall be paid by LICENSOR, provided that if any such inspection shall reveal that an error or omission has been made resulting in an underpayment equal to [***], the costs of such inspection shall be borne by COMPANY. As a condition to entering into any agreement, COMPANY shall include in any agreement with its AFFILIATED COMPANIES or its SUBLICENSEE(S) which permits such party to make, use, offer to sell, sell or import the LICENSED PRODUCT(S) or LICENSED SERVICES, a provision requiring such party to retain records of sales of LICENSED PRODUCT(S) or LICENSED SERVICES and other information as required in Paragraphs 5.1(a) and this Paragraph 5.2 and permit the Auditor to inspect such records as required by this Paragraph 5.2. All information and records made available to the Auditor pursuant to this Paragraph 5.2 shall be deemed to be and treated as Confidential Information of COMPANY pursuant to Article 8. With respect to any audit concerning NOVARTIS and its AFFILIATES, (a) any Auditor shall be approved by NOVARTIS (such approval not to be unreasonably withheld or delayed), (b) such audit shall take place at a mutually agreeable location in New York, New York, United States of America, or another city agreeable to NOVARTIS.

5.7 Section 5.5 is hereby amended and replaced in its entirety as follows:

5.5 Patent Acknowledgement. COMPANY agrees that all packaging containing individual LICENSED PRODUCT(S) sold by COMPANY, AFFILIATED COMPANIES and SUBLICENSEE(S) will be marked with the number of the applicable patent(s) licensed hereunder in accordance with each country’s patent laws, and that patent marking requirements will otherwise be complied with; provided that NOVARTIS and its AFFILIATES will be obligated to mark packaging containing individual LICENSED PRODUCT(S) with the number of the applicable patent(s) licensed hereunder if such LICENSED PRODUCT(S) are marked by other applicable patent(s) not licensed hereunder.

6. Amendment of Article 8 (CONFIDENTIALITY) . The Parties hereby agree to amend Article 8 (CONFIDENTIALITY) of the AGREEMENT as follows:

6.1 The last paragraph of Section 8.1 is hereby amended and replaced in its entirety as follows:

The obligations of this Paragraph shall also apply to AFFILIATED COMPANIES and/or SUBLICENSEE(S) that are provided such Confidential Information by COMPANY. LICENSOR’S, COMPANY’s, AFFILIATED COMPANIES’, and SUBLICENSEES’ obligations under this Paragraph shall extend until [***] of this AGREEMENT. Notwithstanding the foregoing, NOVARTIS’s obligations under this Paragraph shall extend [***] of the NOVARTIS SUBLICENSE AGREEMENT.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

9


7. Amendment of Article 10 (MISCELLANEOUS) . The Parties hereby agree to amend Article 10 (MISCELLANEOUS) of the AGREEMENT as follows:

7.1 Section 10.5 is hereby amended and replaced in its entirety as follows:

10.5 Insurance. Prior to initial human testing or FIRST COMMERCIAL SALE of any LICENSED PRODUCT(S) or LICENSED SERVICES as the case may be and thereafter until [***], COMPANY and SUBLICENSEES shall establish and maintain insurance coverage in such country in the minimum amount of [***], to cover any liability arising from COMPANY’S indemnification obligations under Article 7 above with respect to such human testing or commercial sale of LICENSED PRODUCT(S) or LICENSED SERVICE, and prior to the expiration of such period shall obtain tail coverage for the same limits. Prior to initial human testing or FIRST COMMERCIAL SALE of any LICENSED PRODUCT(S) as the case may be and thereafter until [***], COMPANY and SUBLICENSEES shall establish and maintain, in each country in which COMPANY, an AFFILIATED COMPANY or SUBLICENSEE(S) shall test or sell LICENSED PRODUCT(S), product liability or other appropriate insurance coverage in the minimum amount of [***], and prior to the expiration of such period shall obtain tail coverage for the same limits. COMPANY will annually present evidence, in the form of a statement in the annual report to LICENSOR that such coverage is being maintained. Upon LICENSOR’S request, COMPANY will furnish LICENSOR with a Certificate of Insurance of each insurance policy obtained by COMPANY. LICENSOR and ALSAC shall be listed as additional insureds in COMPANY, AFFILIATED COMPANIES’ and SUBLICENSEES’ said insurance policies. If such insurance is underwritten on a ‘claims made’ basis, COMPANY agrees that any change in underwriters during the term of this AGREEMENT and thereafter so long as LICENSED PRODUCTS are being sold will require the purchase of ‘prior acts’ coverage to ensure that coverage will be continuous throughout the Term of this AGREEMENT and thereafter until [***] following expiration dating of the last batch of LICENSED PRODUCT manufactured. All such insurance shall be primary and non-contributory. All such insurers shall have a minimum financial rating by A.M. Best of [***]. To the extent a SUBLICENSEE, including NOVARTIS and its AFFILIATES, is insured through programs of self-insurance, such SUBLICENSEE is permitted to satisfy its obligations under this Section 10.5 through programs of self-insurance of the types and in the amounts customarily carried to fulfill obligations stated within a sublicense granted under this AGREEMENT, even if such amounts are lower than those specified in this Section 10.5.

8. Amendment of Exhibits . The Parties hereby agree to amend exhibits to the AGREEMENT as follows:

8.1 Exhibit B to the AGREEMENT is hereby deleted and replaced in its entirety by the exhibit bearing the title Exhibit B attached to this AMENDMENT #2.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

10


8.2 Exhibit G attached to this AMENDMENT #2 is hereby added to the AGREEMENT as Exhibit G.

9. Effect on Rights and Obligations . LICENSOR hereby acknowledges and agrees that the NOVARTIS SUBLICENSE AGREEMENT provides a sublicense of patent rights exclusively licensed to COMPANY by LICENSOR under the terms of the AGREEMENT, and that LICENSOR hereby consents to the same under the terms and conditions set forth in the NOVARTIS SUBLICENSE AGREEMENT. Except as otherwise amended by this AMENDMENT #2, the AGREEMENT shall remain in full force and effect as written, and the rights, duties, liabilities and obligations of the PARTIES, as presently constituted, will continue in full force and effect.

10. Conflict . In the event of any conflict between the terms of the AGREEMENT and this AMENDMENT #2, the terms of this AMENDMENT #2 shall govern.

11. Entire Agreement . The AGREEMENT, together with this AMENDMENT #2, constitutes the entire agreement between the PARTIES with respect to the subject matter contained therein and herein, supersedes and replaces any and all prior and contemporaneous understandings, arrangements and agreements, whether oral or written, with respect to such subject matter.

12. Counterparts . This AMENDMENT #2 may be executed in counterparts, each of which shall be deemed an original, but both of which together shall constitute one and the same instrument. Signatures to this AMENDMENT #2 transmitted by facsimile, by email in “portable document format” (“.pdf”), or by any other electronic means intended to preserve the original graphic and pictorial appearance of this AMENDMENT #2 shall have the same effect as physical delivery of the paper document bearing original signature.

[ Signature Page Follows ]

 

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IN WITNESS WHEREOF, this AMENDMENT #2 shall take effect as of the AMENDMENT #2 EFFECTIVE DATE when it has been executed below by the duly authorized representatives of the parties.

 

ST. JUDE CHILDREN’S RESEARCH      JUNO THERAPEUTICS, INC.
HOSPITAL, INC.     

/s/ James R. Downing

    

/s/ Bernard J. Cassidy

Name: James R. Downing      Name: Bernard J. Cassidy
Title: CEO      Title: General Counsel, Secretary

April 4, 2015

    

April 4, 2015

(Date)      (Date)

 

12


EXHIBIT B

LICENSE FEE & ROYALTIES

I. LICENSE FEE: The license fee due under Paragraph 3.1 within [***] of the EFFECTIVE DATE is twenty-five million U.S. dollars ($25,000,000).

II. MINIMUM ANNUAL ROYALTIES: The minimum annual royalties pursuant to Paragraph 3.2 are:

 

  1 st  year - January 1, 2015:    One hundred thousand U.S. dollars ($100,000)
  2 nd  year - January 1, 2016:    One hundred thousand U.S. dollars ($100,000)
  January 1 of every year thereafter    Five hundred thousand U.S. dollars ($500,000)
  during the term of the Agreement:   

III. ROYALTIES: The running royalty rate payable under Paragraph 3.3 is [***] percent ([***]%) of NET SALES. [***]. If a LICENSED PRODUCT OR LICENSED SERVICE is covered by more than one patent or patent application within the PATENT RIGHTS, multiple royalties shall not be due.

IV. SUBLICENSE CONSIDERATION: The SUBLICENSE CONSIDERATION payable under Paragraph 3.4 is as follows:

LICENSOR shall receive [***] of SUBLICENSE CONSIDERATION.

V. NOVARTIS SUBLICENSE AGREEMENT: Notwithstanding anything to the contrary, payments by COMPANY to LICENSOR under the NOVARTIS SUBLICENSE AGREEMENT shall be as follows:

1. Section 3.01 of NOVARTIS SUBLICENSE AGREEMENT—Initial Sublicense Fee ($12,250,000): LICENSOR to first be reimbursed $4,475,592 for pre-EFFECTIVE DATE litigation expenses, and second, after such reimbursement, COMPANY and LICENSOR to each be reimbursed litigation expenses each has paid and had not otherwise been reimbursed, and, third, any remainder to be divided between COMPANY and LICENSOR, [***]% to COMPANY and [***]% to LICENSOR, pursuant to Paragraph 4.3(b) of the AGREEMENT.

2. Section 3.02 of NOVARTIS SUBLICENSE AGREEMENT—Net Sales (Running Royalties and Sublicense Consideration) : Inasmuch as the running royalty to be paid by NOVARTIS on NET SALES of NOVARTIS and its AFFILIATES and PERMITTED SUBLICENSEES, if any, is [***]%, LICENSOR to receive (a) the first [***]% of Net Sales of NOVARTIS and its AFFILIATES as a pass-through to LICENSOR (pursuant to Paragraph 3.3 of the AGREEMENT), and (b) [***]% of the “next” [***]% of running royalties paid by NOVARTIS to COMPANY as SUBLICENSE CONSIDERATION (pursuant to Paragraph 3.4 of the AGREEMENT).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

13


3. Section 3.03 of NOVARTIS SUBLICENSE AGREEMENT—Milestone Payments . Net payments received by COMPANY from NOVARTIS in excess of the pass-through payments owed by COMPANY to LICENSOR (pursuant to Paragraph 3.5 of the AGREEMENT) to be treated as SUBLICENSE CONSIDERATION (pursuant to Paragraph 3.4 of the AGREEMENT) and divided between COMPANY and LICENSOR, [***]% to COMPANY and [***]% to LICENSOR.

4. Section 3.02 of NOVARTIS SUBLICENSE AGREEMENT—Net Sales (Other Royalties and Sublicense Consideration) : LICENSOR to receive [***]% of consideration paid to COMPANY by NOVARTIS under Section 3.02(b) of the NOVARTIS SUBLICENSE AGREEMENT in accordance with Section 4.3(b) of this AGREEMENT as part of the recovery to be received in settlement of the Contract Claim and the Patent Claim.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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EXHIBIT G

NON-EXCLUSIVE SUBLICENSE AGREEMENT

 

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NON-EXCLUSIVE SUBLICENSE AGREEMENT

This Non-Exclusive Sublicense Agreement (“ Agreement ”) is entered into as of the Effective Date by and between Juno Therapeutics, Inc., a Delaware corporation having its principal place of business at 307 Westlake Avenue North, Suite 300, Seattle, Washington 98109, United States of America (“ Juno ”), Novartis Institutes for Biomedical Research, Inc., a Delaware corporation having offices located at 250 Massachusetts Avenue, Cambridge, Massachusetts 02139, United States of America (“ Novartis ”), and The Trustees of the University of Pennsylvania, a nonprofit corporation organized under the laws of Commonwealth of Pennsylvania, United States of America (“ Penn ” and, together with Novartis and Juno, the “ Parties ”).

RECITALS

 

  A. WHEREAS, Juno and St. Jude Children’s Research Hospital, Inc., a nonprofit corporation organized under the laws of State of Tennessee, (“ St. Jude ”) have entered into an exclusive license to certain patent applications and patents (the “ Licensed Patents ”), Including U.S. Patent No. 8,399,645 (the “’ 645 Patent ”), owned by St. Jude for use in humans;

 

  B. WHEREAS, Juno, St. Jude, Novartis and Penn are parties to The Trustees of the University of Pennsylvania v. St. Jude Children’s Research Hospital, Inc. , Civil Action No. 2:13-cv-01502-SD; Trustees of the University of Pennsylvania v. St. Jude’s Children’s Research Hospital , Civil Action No. 2:12-cv-04122-SD; and St. Jude Children’s Research Hospital v. Trustees of the University of Pennsylvania , Civil Action No. 2:12-cv-05878-SD, pending before the United States District Court, Eastern District of Pennsylvania (collectively, the “ Litigation ”); and

 

  C. WHEREAS, Novartis wishes to obtain a non-exclusive license from Juno to the Licensed Patents for use in the Field (as defined below), on the terms and conditions set forth herein.

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

ARTICLE I

DEFINITIONS

The following words and phrases shall have meanings set forth below solely for purposes of this Agreement:

1.01 “ Affiliate ” shall mean any corporation, company, limited liability company or other entity, which controls, is controlled by or is under common control with the Party in question. For purposes of this definition, control shall mean the direct or indirect ownership of

 

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more than fifty percent (50%) of the stock having the right to vote for directors thereof or the ability to otherwise control the management of the corporation, association or other business entity whether through the ownership of voting securities, by contract, resolution, regulation or otherwise.

1.02 “ Assertion Entity ” shall mean each of Penn, Novartis, their respective Affiliates, any sublicensee of Novartis or its Affiliates under this Agreement (permitted in accordance with Section 2.02) and/or any entity that Penn or Novartis, their respective Affiliates, or such sublicensees of Novartis or its Affiliates under this Agreement has authorized to commence or conduct any legal proceeding against Juno, any sublicensee of Juno or St. Jude, or assists in the conduct of any such legal proceeding.

1.03 “ BLA ” shall mean a Biologics License Application, as defined in the U.S. Federal Food, Drug, and Cosmetics Act, as amended, and the regulations promulgated thereunder, any alternate market approval application Including a New Drug Application or 510k application, and any corresponding supranational, foreign or domestic equivalent marketing authorization application, registration or certification, necessary to market a Licensed Product.

1.04 “ Business Day ” shall mean a day on which banking institutions in both Seattle, Washington and Basel, Switzerland are open for business, but in any event excluding the nine (9) consecutive calendar days beginning on December 24th and continuing through January 1st of each calendar year and all Saturdays and Sundays.

1.05 “ Calendar Quarter ” shall mean each three month period commencing January 1, April 1, July 1 and October 1 of each calendar year.

1.06 “ CART-19 ” shall mean a chimeric antigen receptor T cell directed against CD19.

1.07 “ CART-19 Supplier ” shall mean any supplier, contractor or manufacturing organization with respect to any component, product candidate, product and/or service provided by such party, directly or indirectly, in connection with any CART-19 product or CART-19 service (Including the use, manufacture or provision thereof), solely when and to the extent that such party is acting in such capacity related to such CART-19 product or CART-19 service.

1.08 “ Effective Date ” shall mean the date on which the parties file the form of dismissal attached hereto as Exhibit 5.02, pursuant to Article V of this Agreement and subject to the conditions set forth therein.

1.09 “ FDA ” shall mean the United States Food and Drug Administration, or any successor agency thereto.

1.10 “ Field ” shall mean all therapeutic, diagnostic, preventative and palliative uses.

 

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1.11 “ First Assert ” shall mean any legal proceeding commenced or otherwise prosecuted by any Assertion Entity, Including any legal proceeding conducted by any entity that is acquired by or merged with any Assertion Entity (“ Control Transaction ”) that, prior to such Control Transaction, initiated legal proceedings against Juno or St. Jude that are not terminated within [***] days of the close of such Control Transaction, whether such legal proceeding is before a court of law, an administrative body (Including the U.S. Patent and Trademark Office or the International Trade Commission) or any other tribunal entity, where relief is sought to invalidate a Licensed Patent before St. Jude, Juno or their respective Affiliates has commenced or otherwise prosecuted any similar proceedings against Penn, Novartis or their respective Affiliates.

1.12 “ First Commercial Sale ” shall mean (a) the first sale in the Territory of Licensed Product by Novartis, its Affiliates or Permitted Sublicensees to a Third Party after such Licensed Product has been granted regulatory approval, Including pricing approval, by the appropriate regulatory authority(ies) for the relevant country or region or (b) the first performance of a Licensed Service in exchange for consideration. First Commercial Sale excludes any sale or other distribution of Licensed Product for use in a clinical trial or other development activity, for promotional use, Including samples, or for use in a compassionate use or similar program.

1.13 “Including” shall mean “including but not limited to” and “including without limitation.”

1.14 “ Licensed Patents ” shall mean (a) the patent and patent applications listed on Exhibit 1.14 hereto; (b) any other patent or patent application that is a divisional, continuation, reissue, renewal, reexamination, substitution or extension of any patent or patent application identified in (a); (c) any patents subsequently issuing on any patent application identified in (a) or (b), Including any reissues, renewals, reexaminations, substitutions or extensions thereof; and (d) those claims of a continuation-in-part application or patent (Including any reissues, renewals, reexaminations, substitutions or extensions thereof) that are entitled to the priority date of at least one of the patents or patent applications identified in (a), (b) or (c). Specifically excluded from Licensed Patents are U.S. Patent Nos. [***] and [***], and any other patent or patent application that claims priority to, or common priority with, or is a divisional, continuation, re-issue, renewal, reexamination, substitution or extension of any patent or patent application identified in clause (a) above that contains only claims directed to the [***].

1.15 “ Licensed Product ” shall mean any material, cell, composition or drug, the manufacture, use, importation, offer for sale or sale of which would infringe any Valid Claim but for the license granted under this Agreement. For the avoidance of doubt, as of the Effective Date ( i.e., as the Licensed Patents and Valid Claims thereunder exist as of the Effective Date), the [***] are Licensed Products, as defined under this Agreement.

1.16 “ Licensed Services ” shall mean any service using a Licensed Product, the performance of which would infringe a Valid Claim but for the license granted under this Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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1.17 “ Net Sales ” shall mean the net sales in the Territory recorded by Novartis or any of its Affiliates or Permitted Sublicensees for sale of any Licensed Product to, and performance of any Licensed Service for, a Third Party other than a Permitted Sublicensee, distributor and wholesaler, as [***]. The deductions booked on an accrual basis by Novartis, its Affiliates and its Permitted Sublicensees under Novartis Accounting Standards, to calculate the recorded net sales from gross sales include the following, in each case, to the extent actually accrued, discounted or credited, as applicable, and without duplication:

 

  (i) customary trade and cash discounts;

 

  (ii) amounts repaid or credited by reasons of defects, rejections or recalls or returns;

 

  (iii) [***];

 

  (iv) [***];

 

  (v) [***];

 

  (vi) [***];

 

  (vii) [***]; and

 

  (viii) other reductions for specifically identifiable amounts deducted for reasons substantially similar to those listed in clauses (i) through (vii) above if [***].

With respect to the calculation of Net Sales:

 

  (A) [***]; and

 

  (B) If a Licensed Product is delivered to the Third Party before being invoiced (or is not invoiced), Net Sales will be calculated [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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1.18 “ Novartis Accounting Standards ” shall mean the IFRS (International Financial Reporting Standards), as generally and consistently applied throughout the Novartis’s organization. Novartis shall promptly notify Juno in the event that it changes the Novartis Accounting Standards pursuant to which its records are maintained, it being understood that Novartis may only use internationally recognized accounting principles ( e.g. , IFRS, US GAAP, etc.).

1.19 “ Penn-Novartis Collaboration ” shall mean that certain Collaboration and License Agreement entered by and between Penn and Novartis effective August 3, 2012, a redacted copy of which has been provided to Juno and St. Jude.

1.20 “ Penn Construct ” shall mean a CART-19 that includes [***].

1.21 “ Penn-Novartis Parties ” shall mean Penn and its Affiliates as well as Novartis and its Affiliates.

1.22 “ Permitted Sublicensees ” shall mean Third Parties that are permitted sublicensees of Novartis under the Penn-Novartis Collaboration that become sublicensed under the Penn-Novartis Collaboration to participate in the commercialization of products as contemplated by the Penn-Novartis Collaboration.

1.23 “ Person ” shall mean an individual, trust, corporation, partnership, joint venture, limited liability company, association, unincorporated organization or other legal or governmental entity.

1.24 “ Phase I Clinical Trial ” shall mean a human clinical trial, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients as required in 21 C.F.R. § 312, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States.

1.25 “ Phase II Clinical Trial ” shall mean (a) a human clinical trial, for which a primary endpoint is a preliminary determination of efficacy or dose ranges in patients with the disease target being studied as required in 21 C.F.R. § 312.21(b), as may be amended from time to time, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States, (b) a combined Phase I and Phase II Clinical Trial which [***], or (c) any Phase III Clinical Trial performed in lieu of a Phase II study.

1.26 “ Phase III Clinical Trial ” shall mean a human clinical trial, the principal purpose of which is to establish safety and efficacy in patients with the disease target being studied as required in 21 C.F.R. § 312, or similar clinical study prescribed by the regulatory authorities in a country other than the United States. A Phase III Clinical Trial shall also include any other human clinical trial intended as a pivotal study (a Phase II trial that provides evidence for a drug marketing approval), whether or not such study is a traditional Phase III study.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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1.27 “ Settlement Agreement ” shall mean that certain agreement entered by and between Juno, St. Jude, Penn and Novartis on the same date herewith, which is incorporated herein by reference.

1.28 “ St. Jude Agreement ” shall mean that certain Exclusive License Agreement entered by and between Juno and St. Jude effective December 3, 2013, a redacted copy of which is attached as Exhibit 1.28 hereto.

1.29 “ St. Jude-Juno Parties ” shall mean St. Jude and its Affiliates as well as Juno and its Affiliates.

1.30 “ Term of this Agreement ” shall have the meaning set forth in Section 12.01.

1.31 “ Territory ” shall mean the United States of America (“ U.S. ”), Including its territories and possessions.

1.32 “ Third Party ” shall mean any Person other than Juno or Novartis or any of their respective Affiliates.

1.33 “ Valid Claim ” as used herein, in either singular or plural, shall mean a claim of any issued and unexpired patent included within the Licensed Patents and (a) such claim has not been held permanently revoked, unenforceable or invalid by the final, un-reversed, and un-appealable, or unappealed within the time allowed for appeal, decision of a court or other government body of competent jurisdiction, has been irretrievably abandoned or disclaimed, and (b) such claim has not otherwise been finally admitted or determined to be invalid, unpatentable or unenforceable, whether through reissue, reexamination, disclaimer or otherwise. A pending claim of a patent application within the Licensed Patents which has been pending for a period of [***] or fewer years after filing shall also constitute a Valid Claim if (i) the claim continues to be prosecuted in good faith and has not been cancelled, withdrawn, abandoned or finally disallowed without the possibility of appeal or re-filing of such application, and (ii) there exists an issued Valid Claim for which the provisions of (a) and (b) are satisfied.

ARTICLE II

GRANTS

2.01 Sublicense to Licensed Patents . Subject to the terms and conditions of this Agreement, Juno hereby grants to Novartis and Affiliates of Novartis, and Novartis and Affiliates of Novartis hereby accept, a non-exclusive sublicense under the Licensed Patents for the Term of this Agreement to develop, have developed, make, have made, use, have used, import, offer for sale, have offered for sale, sell and have sold Licensed Products and Licensed Services, in each

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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case, in the Field in the Territory. Novartis and its Affiliates agree and acknowledge that the foregoing “have” rights will be exercised with Third Parties acting for the benefit of Novartis and/or its Affiliates in connection with the manufacture, development and/or commercialization of Licensed Products and Licensed Services that are owned or controlled by Novartis and/or its Affiliates, Including with respect to any CART-19 Suppliers of Novartis and its Affiliates. Subject to the terms and conditions of this Agreement, Juno hereby also grants to Penn, and Penn hereby accepts, a non-exclusive license under the Licensed Patents for the Term of this Agreement to make and use Licensed Products and to perform Licensed Services, in connection with research and development activities, Including clinical trials and studies, in each case, in the Field in the Territory; provided, however, that the exercise of any such rights by Penn is solely in support of the rights granted to Novartis under this Agreement.

2.02 Limited Sublicense Right . Novartis and Affiliates of Novartis may not grant or authorize any sublicense under the Licensed Patents without the express prior written consent of Juno, which consent may be granted or not granted in Juno’s discretion. For the avoidance of doubt, the foregoing shall not prevent Novartis from exercising the ‘have’ rights provided in Section 2.01 with respect to Licensed Products and/or Licensed Services. Novartis shall ensure that any Third Party that receives such a ‘have’ right will be bound by, and will abide by, the applicable terms of this Agreement. Penn may not grant or authorize any sublicense of the rights under the Licensed Patents granted to it hereunder without the express prior written consent of Juno, which consent may be granted or not granted in Juno’s discretion.

2.03 Reserved Rights . Novartis, Affiliates of Novartis, and Penn acknowledge that the Licensed Patents were made with funds provided by the United States Government, and the rights granted herein are subject to obligations to the U.S. Government set forth in the Bayh-Dole Act, 35 USC § 200 et seq. , Including an obligation to manufacture in the U.S. Licensed Products that will be sold in the U.S. In their practice of the sublicense to the Licensed Patents, Novartis, Affiliates of Novartis, and Penn agree to comply with all provisions of 35 USC § 200 et seq. and implementing regulations. Novartis, Affiliates of Novartis, and Penn further acknowledge that the St. Jude Agreement (a) reserves for St. Jude certain rights to practice the Licensed Patents, and (b) that Juno retains the right to practice the Licensed Patents and to grant one or more Third Parties licenses to the Licensed Patents (subject to the license rights granted to Novartis and Penn hereunder).

2.04 Sublicense; Supremacy of this Agreement . Novartis, Affiliates of Novartis, and Penn acknowledge that this Agreement provides a sublicense of patent rights exclusively licensed to Juno by St. Jude in the St. Jude Agreement. To the extent this Agreement deviates from the St. Jude Agreement, Juno acknowledges and consents to such deviations and agrees that this Agreement provides the definitive statement of terms and conditions applicable to Novartis, Affiliates of Novartis, and Penn, each as such rights and obligations are expressly set forth herein.

2.05 Limited License . Novartis, Affiliates of Novartis, and Penn each acknowledge and agree that (a) no license other than that expressly set forth in Section 2.01 is or shall be deemed to have been granted under this Agreement, whether by implication, estoppel or otherwise, and (b) the license granted under this Article II is limited in scope and does not confer on Novartis or its

 

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Affiliates or Penn or its Affiliates any license (express or implied) or any other rights to: (i) develop, make, have made, use, import, promote, distribute, market, sell, offer for sale or have sold any product that is not a Licensed Product, or any service that is not a Licensed Service, for any use or purpose; or (ii) develop, make, have made, use, import, promote, distribute, market, sell, offer for sale or have sold any Licensed Product or Licensed Service outside the Territory for any use or purpose.

2.06 No Implied Licenses . No license or other right is or shall be created or granted hereunder by implication, estoppel or otherwise. All licenses and rights are and shall be granted only as expressly provided in this Agreement. All rights not expressly granted by a Party under this Agreement are reserved by such Party and may be used by such Party for any purpose.

ARTICLE III

CONSIDERATION

3.01 Initial License Fee . Within [***] after the Effective Date, Novartis shall pay to Juno a license fee of twelve million two hundred fifty thousand U.S. dollars ($12,250,000).

3.02 Royalties .

(a) Running Royalties . Novartis shall pay to Juno running royalties of [***] percent ([***]%) of Net Sales of Licensed Products sold by Novartis, its Affiliates and Permitted Sublicensees in the Territory, Including where such sales occur in connection with the use of Licensed Products in the performance of Licensed Services.

(b) Other Royalties . In addition, Novartis shall pay to Juno [***] percent ([***]%) of the royalties that would be due under the royalty basis described in the attached Exhibit 3.02(b) , as if paid by Novartis to Penn for Net Sales of Licensed Products pursuant to the Penn-Novartis Collaboration (Including as such basis may be applied to Licensed Services as contemplated under this Agreement in the definition of Net Sales provided herein as well as Licensed Products, whether murine, human or other forms of CART19) as of the Effective Date. For example, and not by way of limitation, Novartis may owe Juno [***] percent ([***]%) of the [***] percent ([***]%) royalty expressed on the top left corner of the first Table expressed in Exhibit 3.02(b) ( i.e. , the top row of Table A in Exhibit 3.02(b) under the heading “I. Royalty Rate Applicable to any Initial CED-19 Product”), but applying the definition of Net Sales provided hereunder. Juno acknowledges and agrees that “royalty payments” as used in the foregoing sentence does not include [***]. Notwithstanding anything to the contrary, if Novartis and Penn agree at any time after the Effective Date to amend any aspect of the Penn-Novartis Collaboration that alters the terms for payment of royalties under the Penn-Novartis Collaboration, and such alteration would reduce the royalty payment owed to Penn, then such amended terms shall not in any manner reduce the royalty payment due to Juno under this Agreement determined as of the Effective Date; provided, however, if Novartis and Penn amend the Penn-Novartis Collaboration or otherwise enter into an agreement on or after the Effective Date that increases the royalty payment payable by Novartis to Penn pursuant to the Penn-Novartis Collaboration, then Exhibit 3.02(b) shall be deemed amended to reflect any such increase, and the royalty payment due to Juno shall be increased to correspond to the amended Exhibit 3.02(b) .

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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(c) Royalty Term . Royalties shall be due on a Licensed Product-by-Licensed Product basis, commencing on the First Commercial Sale of the applicable Licensed Product and continuing until the expiration or abandonment of the last applicable Valid Claim. Novartis’ obligation to pay royalties to Juno under this Agreement shall be imposed only once with respect to the same unit of Licensed Product, notwithstanding such Licensed Product may be covered by more than one Valid Claim of a Licensed Patent.

(d) [***]. The royalties due to Juno shall [***].

(e) Form of Consideration . Without the further prior express written consent of Juno, Novartis, its Affiliates and Permitted Sublicensees shall not solicit or accept any consideration for the sale of any Licensed Product, or the performance of any Licensed Service, other than as will be fully reflected in Net Sales.

(f) Royalty Payment . Novartis shall pay to Juno on [***] basis all royalties due and payable on Net Sales in each [***] pursuant to this Section 3.02 within [***] after the last day of each [***] in which the applicable Net Sales underlying such royalties were billed or invoiced by Novartis.

3.03 Milestone Payments . Within [***] after the first achievement of any of the following milestone events with regard to any Licensed Product, or within [***] after the Effective Date for those milestone events that have already been achieved as of the Effective Date, Novartis shall notify Juno of such achievement. Novartis shall concurrently with the applicable notice pay to Juno the payment in the applicable amounts set forth in this Section 3.03 (each an “ Event Payment ”).

 

(a) [***]:

   $[***]

(b) [***]:

   $[***]

(c) [***]:

   $[***]

(d) [***]:

   $[***]

(e) [***]:

   $[***]

(f) [***]:

   $[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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3.04 Milestone Payment Adjustments . With respect to each of the Event Payments specified in Section 3.03, the amount payable by Novartis shall be adjusted as follows:

(a) If, as between Novartis and Juno, Novartis is the first Party to achieve the milestone event, then Novartis shall pay to Juno the relevant Event Payment pursuant to the terms described in Section 3.03. If after Novartis reaches the milestone event, Juno also achieves the milestone event, Juno shall reimburse to Novartis fifty percent (50%) of the Event Payment actually paid by Novartis to Juno.

(b) If, as between Novartis and Juno, Novartis is the second Party to achieve the milestone event, then Novartis shall pay to Juno fifty percent (50%) of the relevant Event Payment pursuant to the terms described in Section 3.03.

(c) Within [***] after the first achievement by Juno of any milestone event, or within [***] after the Effective Date for those milestone events that have already been achieved by Juno as of the Effective Date, Juno shall notify Novartis of such achievement. Juno shall concurrently with the applicable notice reimburse Novartis as set forth in Section 3.04(a).

3.05 Non-creditable Payments . Subject to Sections 3.03 and 3.04, all payments made to Juno pursuant to this Article III shall be [***] and shall not be creditable against any other amount due to Juno pursuant to this Agreement.

3.06 Other Consideration .

(a) Past Acknowledgement

(i) New England Journal of Medicine . Within [***] after the Effective Date, Penn shall submit to New England Journal of Medicine [***] the letter to the editor attached hereto as Exhibit 3.06(a)(i) .

(ii) Science Translational Medicine . Within [***] after the Effective Date, Penn shall submit to Science Translational Medicine for [***] the letter to the editor attached hereto as Exhibit 3.06(a)(ii) .

(iii) Other Publications . Subject to Section 3.06(d), Penn shall provide St. Jude and Juno with copies of all publications dating prior to the Effective Date which report a study involving Penn’s use of the Penn Construct. [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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[***].

(b) Future Acknowledgement . Subject to Section 3.06(d), during a [***] time period commencing on the Effective Date, all future publications authored, co-authored or released by Penn or by any then-current Penn faculty member or employee, which report a study involving Penn’s use of the Penn Construct shall include the following acknowledgement:

[***].

(c) Notification of Transfers and Provision of Agreements . Novartis and Penn shall not seek to obstruct or interfere with St. Jude or Juno if St. Jude or Juno attempts to communicate with any Third Party listed in Exhibit 8.03(d) or Exhibit 8.03(e) .

(d) Except as provided elsewhere in this Agreement, the parties agree that any Penn Construct first made [***].

ARTICLE IV

GENERAL FINANCIAL MATTERS AND REPORTS

4.01 Royalty Reports . Commencing with the First Commercial Sale and for the remaining Term of this Agreement, Novartis shall submit [***] to St. Jude and Juno a written royalty report (“ Royalty Report ”), in the form provided in Exhibit 4.01 , covering sales of each Licensed Product for each [***] with the following information for each of Novartis, its Affiliates and Permitted Sublicensees, on a Licensed Product-by-Licensed Product basis:

(a) [***];

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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(b) [***];

(c) [***]; and

(d) [***].

Royalty Reports shall be provided to Juno for the Territory no later than [***] after the end of the [***] to which they pertain.

4.02 Timing of Royalty Payments . Novartis shall make any royalty payments due pursuant to Article III concurrently with Novartis’s provision of the Royalty Report required by Section 4.01 for the relevant [***].

4.03 Records . Novartis, its Affiliates and Permitted Sublicensees shall keep and maintain true and accurate records, files and books of account of all sales of all Licensed Products in the Territory for at least [***] after the [***] in which such Net Sales are made, in sufficient detail to permit Juno to confirm the accuracy of Net Sales and royalty calculations, a full computation and verification of sales and other information required in Section 4.01 by Novartis. Such books and records shall be in accordance with Novartis Accounting Standards, consistently applied.

4.04 Audit . At Juno’s request and expense, Novartis shall permit an independent nationally recognized certified public accountant appointed by Juno and approved by Novartis (such approval not to be unreasonably withheld or delayed) to examine at a mutually agreeable location in New York, New York, United States of America, or another city as to which Juno and Novartis may mutually agree, upon reasonable notice and at reasonable times, Novartis’s records to verify Net Sales calculations (Including the details of all deductions taken from gross invoiced sales price to arrive at Net Sales) and royalty calculations made by Novartis. Any such examination shall occur during regular business hours upon [***] written notice to Novartis but not more than once in a twelve (12) month period. The appointed accountant shall enter into a confidentiality agreement with Novartis upon terms comparable to those in Article XI, which confidentiality agreement shall continue to apply to any information provided to such accountant for the examination unless and until such information (a) becomes generally available to the public other than through any breach of the confidentiality agreement by such accountant, or (b) becomes known to such accountant other than from or through a Person having an obligation to Novartis not to disclose such information. Novartis shall provide the appointed accountant access to such records that in the ordinary course of business are in the possession, custody or control of Novartis, its Affiliates and Permitted Sublicensees. Novartis shall also cause each of its Affiliates and Permitted Sublicensees to make available for inspection by the appointed accountant, at a mutually convenient location in the United States, true, complete and accurate records of Affiliate’s and/or Permitted Sublicensees’ sales of all Licensed Products and Licensed Services in sufficient detail to permit Juno to confirm the accuracy of Novartis’s Net Sales calculations and royalty calculations based on such Affiliate’s or Permitted Sublicensees’ sales. The report of any such examination shall be made simultaneously to Juno, St. Jude and Novartis, and shall include a

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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statement of the amount, if any, by which Novartis has underpaid or overpaid its royalties, and the nature and basis of the underpayment or overpayment. The decision of the auditor shall be final, binding and incontestable. In the event of an underpayment of royalties, Novartis shall promptly pay the deficiency plus interest pursuant to Section 4.07 to Juno; and if royalties to Juno were underpaid by [***] in any [***], then Novartis shall additionally reimburse Juno for its reasonable costs incurred in examining such records.

4.05 Payments . All amounts owed by Novartis to Juno under this Agreement shall be paid in U.S. dollars by wire transfer of immediately available funds to such bank account as Juno may from time to time designate in writing.

4.06 Exchange Rates . If by law, regulations or fiscal policies, remittance of royalties in Dollars is prohibited or restricted, Novartis will notify Juno and payment of the royalty obligations shall be made by deposit thereof in local currency to the credit of Juno in a recognized banking institution designated by Juno.

4.07 Late Payments; Interest . In the event that any payment due hereunder is not made when payable, the payment shall accrue interest beginning on the [***] following the due date thereof, calculated at the rate of [***] per month from the date said payment is due, provided however, said annual interest rate shall not exceed the maximum legal interest rate for corporations. Each such payment when made shall be accompanied by all interest so accrued. The payment of any such interest and acceptance thereof shall not negate or waive the right of Juno to seek any other remedy, legal or equitable, to which it may be entitled because of the delinquency of any payment Including termination of this Agreement.

4.08 Taxes

(a) Withholding Taxes . [***].

(b) Other Taxes . Any sales taxes ( e.g. , consumption or value added taxes), use taxes, transfer taxes, value added, duties and other taxes or governmental charges required to be paid with regard to any Licensed Products or Licensed Services shall be the sole responsibility of Novartis. In the event that Juno is required to pay any such amounts, Novartis shall promptly remit payment to Juno of such amounts following receipt of an invoice therefor.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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4.09 Finality . Novartis hereby releases and forever waives any right to challenge or dispute any amounts paid or owed on Licensed Products pursuant to the terms and conditions of this Agreement, except to the extent Juno and Novartis have a disagreement with respect to the calculation of Net Sales or the timing of the royalty payments owed on Net Sales or any milestone payments due hereunder.

ARTICLE V

SETTLEMENT OF THE LITIGATION

5.01 Contemporaneously with the execution of this Agreement, the Parties (together with St. Jude) shall execute the Settlement Agreement, which is incorporated herein by reference.

5.02 Within five (5) days after the execution of the Settlement Agreement, the Parties (together with St. Jude) shall file a dismissal with prejudice of all claims and counterclaims asserted in the Litigation by filing the form of dismissal attached hereto as Exhibit 5.02 . Novartis, Juno, and Penn agree that in the event the Licensed Patents, Including any liability thereunder, are ever asserted against any of Penn or Novartis, or their respective Affiliates, or any of their respective assigns or successors in interest, by any of Juno or St. Jude, or their respective Affiliates, or any of their respective assigns or successors in interest, Penn, Novartis, their respective Affiliates and their respective assigns or successors in interest expressly reserve the right to assert non-infringement, invalidity and unenforceability of the Licensed Patents, either by way of counterclaim or defense.

ARTICLE VI

LIMITED LITIGATION STANDSTILL

6.01 During the time period commencing on the Effective Date and extending through the later of [***], and only during such period, except for any breach of this Agreement, (a) none of the St. Jude-Juno Parties may file, assist in the filing of, or otherwise support, encourage, or be involved in the filing or maintenance of (i) any action, lawsuit, arbitral proceeding, or the seeking of an investigation under the Tariff Act of 1930 (“ Action ”), Including the filing of any infringement or declaratory judgment action, against any of the Penn-Novartis Parties or their CART-19 Suppliers with respect to any CART-19 product or service (or any component thereof) or (ii) any review by a court, administrative agency or any other forum of any patent or patent application owned or controlled by the Penn-Novartis Parties relating to any CART-19 product or service (or any component thereof), and (b) none of the Penn-Novartis Parties may file, assist in the filing of, or otherwise support, encourage, or be involved in the filing or maintenance of (i) any Action, Including the filing of any infringement or declaratory judgment action, against any of the St. Jude-Juno Parties or their CART-19 Suppliers with respect to any CART-19 product or service (or any component thereof) or (ii) any review by a court, administrative agency or any other forum of any patent or patent application owned or controlled by the St. Jude-Juno Parties relating to any CART-19 product or service (or any component thereof).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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6.02 During the time period commencing upon the expiration of the time period set forth in Section 6.01 and continuing until [***], prior to any of the St. Jude-Juno Parties, on the one hand, or any of the Penn-Novartis Parties, on the other hand, (collectively, as applicable, the St. Jude-Juno Parties or the Penn-Novartis Parties as a group, the “ Litigating Parties ”) filing, assisting in the filing of, or otherwise supporting, encouraging, or being involved in the filing or maintenance of any (a) Action, Including the filing of any infringement or declaratory judgment action, against any of the Penn-Novartis Parties (in the case of the St. Jude-Juno Parties as the Litigating Parties) or any of the St. Jude-Juno Parties (in the case of the Penn-Novartis Parties as the Litigating Parties), as applicable (collectively, as applicable, the Penn-Novartis Parties or the St. Jude-Juno Parties as a group, the “ Responding Parties ”), with respect to any CART-19 product or service (or any component thereof), or (b) any review by a court, administrative agency or any other forum of any patent or patent application owned or controlled by the Responding Parties relating to any CART-19 product or service (or any component thereof), the Litigating Parties shall give the Responding Parties at least [***] notice and during such [***] period of time such parties shall engage in discussions regarding such potential Action or such review by a court, administrative agency or any other forum to see if such parties may be able to settle the matter without engaging in such potential Action or court, administrative agency or any other forum review. However, if no such settlement is reached in a definitive written agreement, (i) the Litigating Parties shall no longer be restrained by this Section 6.02 with regard to the Action or court, administrative agency or any other forum review with respect to which it gave notice to the Responding Parties, and (ii) both the Responding Parties and the Litigating Parties shall be free to raise whatever related defenses and make additional assertions as they otherwise would in the conduct of such matters without having to give notice under or otherwise being restrained by this Section 6.02, provided it is understood and agreed that during the [***] period following the end of such [***] period, only the Litigating Parties (and not the Responding Parties) may file or assist in the filing of such Action or court, administrative agency or any other forum review.

6.03 Notwithstanding anything to the contrary and for the avoidance of doubt:

(a) any damages that may be available based on any alleged infringement or related claims specific to any CART-19 product or service (or any component thereof) will continue to accrue during the Term of this Agreement, Including during any notice or longer periods of negotiations occurring under Section 6.02;

(b) a Party’s agreement to, or compliance with, the terms of this Article VI during the Term of this Agreement will not be deemed or construed to (i) grant or exhaust any patent rights (whether express or implied), or (ii) waive any rights, damages, or remedies that would otherwise be available; and

(c) during the Term of this Agreement all time-based defenses ( e.g. , statutes of limitations and laches) to any Action or any review by a court, administrative agency or any other forum that are subject to Section 6.01 and/or Section 6.02, Including calculations of time thereunder and the running of any deadlines associated therewith, will be tolled only for the duration of any standstill provided for in Section 6.01 and/or Section 6.02, as applicable.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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ARTICLE VII

PATENT CHALLENGE

7.01 Challenge to Validity/Enforceability of Licensed Patents by an Assertion Entity. No Assertion Entity shall First Assert any challenge to the validity or enforceability of any Licensed Patent(s) in any court, administrative agency or any other forum (“ Challenge ”). Any breach of the foregoing shall be deemed a material breach of this Agreement, as a result of which Juno may, at its sole discretion, terminate this Agreement with notice to Novartis. In the event of such termination by Juno, the sublicense granted herein to Novartis shall terminate immediately. If any Assertion Entity commences any Challenge while this Agreement remains in force, Juno, in its sole discretion, may terminate this Agreement. If Juno determines not to terminate the Agreement, then the Assertion Entity shall reimburse Juno for any and all costs and expenses incurred by Juno in defense and settlement of such proceedings (Including damages, settlement payments, attorneys’ fees, expert witness fees and court costs). Such reimbursements shall be paid by the Assertion Entity within [***] after each invoice for such costs and expenses is submitted to the Assertion Entity by Juno or Juno’s counsel. Failure to timely reimburse such costs and expenses will constitute a material breach of this Agreement. In addition, any payments required hereunder must be timely made in full when due, in cash and readily available funds; and once paid, no such amounts will be subject to replevin, refund or recovery by the Assertion Entity, its Affiliates or Permitted Sublicensees, irrespective of whether such challenge was successful.

ARTICLE VIII

REPRESENTATIONS, WARRANTIES AND COVENANTS;

DISCLAIMER; LIMITATION OF LIABILITY

8.01 Representations by Juno . Juno represents and warrants to the other Parties that:

(a) as of the Effective Date Juno is a corporation, duly organized, validly existing and in good standing under the laws of State of Delaware;

(b) the execution, delivery and performance of this Agreement has been duly authorized by all necessary corporate action on the part of Juno;

(c) the execution, delivery and performance of this Agreement shall not conflict in any material fashion with the terms of any other agreement or instrument to which it is or becomes bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority;

(d) it has the right to grant the sublicense under the Licensed Patents set forth in this Agreement; and

(e) as of the Effective Date, Juno is not a party to any action, lawsuit, arbitral proceeding or administrative proceeding against Penn and/or Novartis other than the Litigation.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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8.02 Representations by Novartis . Novartis represents and warrants to the other Parties that:

(a) as of the Effective Date Novartis is a corporation, duly organized, validly existing and in good standing under the laws of Switzerland;

(b) the execution, delivery and performance of this Agreement has been duly authorized by all necessary corporate action on the part of Novartis;

(c) the execution, delivery and performance of this Agreement shall not conflict in any material fashion with the terms of any other agreement or instrument to which it is or becomes bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority;

(d) as of the Effective Date, it is not a party to any action, lawsuit, arbitral proceeding or administrative proceeding against St. Jude and/or Juno other than the Litigation; and

(e) it acknowledges and agrees that as of the Effective Date ( i.e., as the Licensed Patents and Valid Claims thereunder exist as of the Effective Date), [***], as defined under this Agreement.

8.03 Representations by Penn . Penn represents and warrants to the other Parties that:

(a) as of the Effective Date Penn is a nonprofit corporation organized, validly existing and in good standing under the laws of Commonwealth of Pennsylvania;

(b) the execution, delivery and performance of this Agreement has been duly authorized by all necessary corporate action on the part of Penn;

(c) the execution, delivery and performance of this Agreement shall not conflict in any material fashion with the terms of any other agreement or instrument to which it is or becomes bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority;

(d) Subject to Section 3.06(d), Exhibit 8.03(d) contains a true and complete list of the names, affiliations, and addresses of any and all Third Parties to whom the Penn Construct has been provided by Penn;

(e) Exhibit 8.03(e) contains a true and complete list of the names, affiliations, and addresses of any and all Third Parties with whom Penn has entered into any agreement(s) relating to actual commercialization involving the Penn Construct;

(f) as of the Effective Date, Penn is not a party to any action, lawsuit, arbitral proceeding or administrative proceeding against St. Jude and/or Juno other than the Litigation; and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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(g) Penn acknowledges and agrees that as of the Effective Date ( i.e., as the Licensed Patents and Valid Claims thereunder exist as of the Effective Date), [***], as defined under this Agreement.

8.04 Disclaimer of Warranties . Nothing in this Agreement is or shall be construed as:

(a) A warranty or representation by Juno as to the scope, validity or enforceability of any claim or patent or patent application within the Licensed Patents;

(b) A warranty or representation by Juno that anything made, used, offered for sale, sold or otherwise disposed of by Novartis, its Affiliates or Permitted Sublicensees under any sublicense granted in this Agreement is or will be free from infringement of any patent rights or other intellectual property right of any Third Party or any other patent rights or other intellectual property owned or controlled by Juno;

(c) A grant by Juno, whether by implication, estoppel or otherwise, of any licenses other than those expressly granted under Article II; or

(d) An obligation on the part of Juno to bring or prosecute actions or suits against any Third Party for infringement of any of the Licensed Patents.

8.05 Further Disclaimers . EXCEPT AS OTHERWISE PROVIDED HEREIN, THE LICENSED PATENTS ARE LICENSED “AS IS”, AND JUNO SPECIFICALLY DISCLAIMS ANY EXPRESS OR IMPLIED WARRANTY (EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE) OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR PATENTABILITY, VALIDITY, OR ENFORCEABILITY OF THE LICENSED PATENTS, OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY OWNED BY A THIRD PARTY ARISING FROM ANY PRACTICE OF THE LICENSED PATENTS. JUNO FURTHER DISCLAIMS ALL WARRANTIES WITH REGARD TO LICENSED PRODUCT(S) USED, MADE OR SOLD AND/OR LICENSED SERVICES PERFORMED BY NOVARTIS, ITS AFFILIATES OR PERMITTED LICENSEES INCLUDING, BUT NOT LIMITED TO, THEIR SAFETY, EFFECTIVENESS OR COMMERCIAL VIABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE

ARTICLE IX

LIMITATION OF LIABILITY

9.01 Limitation of Liability . NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, JUNO AND EACH OF THE INVENTORS OF THE LICENSED PATENTS SHALL HAVE NO LIABILITIES FOR DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL, AND CONSEQUENTIAL DAMAGES, ATTORNEYS’ AND EXPERTS’ FEES, AND COURT COSTS (EVEN IF SUCH ENTITIES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE,

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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IMPORTATION, OFFER FOR SALE OR SALE OF ANY LICENSED PRODUCT(S) AND/OR LICENSED SERVICES BY OR ON BEHALF OF NOVARTIS, ITS AFFILIATES OR PERMITTED SUBLICENSEES. NOVARTIS HEREBY ASSUMES ALL RESPONSIBILITY AND LIABILITY FOR ANY LOSS, LIABILITY OR DAMAGE CAUSED BY ANY LICENSED PRODUCT OR LICENSED SERVICE BY OR ON BEHALF OF NOVARTIS, ITS AFFILIATES OR PERMITTED SUBLICENSEES.

ARTICLE X

INDEMNIFICATION; INSURANCE

10.01 Indemnification for Breach of Warranty . Any Party that breaches any warranty or covenant set forth in Article VIII shall indemnify, defend and hold harmless the other Parties and their respective Affiliates, and each of their respective directors, officers, employees and agents, from and against any and all liabilities, claims, demands, expenses (Including reasonable attorneys’ and professional fees and other costs of litigation), losses or causes of action arising out of or relating to any such breach of warranty.

10.02 Indemnification of Juno Indemnitees . Novartis shall, indemnify, defend, with counsel reasonably acceptable to Juno, and hold Juno, its Affiliates, and each of their respective directors, officers, employees and agents (each a “ Juno Indemnitee ”) harmless from and against any and all liabilities, claims, demands, judgments, expenses (Including reasonable attorneys’ and professional fees and other costs of litigation), losses or causes of action (each, a “ Liability ”) a Juno Indemnitee may be required to pay to one or more Third Parties to the extent resulting from or arising out of [***].

10.03 Indemnification of St. Jude Indemnitees . Novartis shall, indemnify, defend, with counsel reasonably acceptable to St. Jude, and hold St. Jude, the American Lebanese Syrian Associated Charities, Inc. (ALSAC; a non-profit, 501(c)(3) corporation which supports St. Jude), their present and former trustees, directors, governors, officers, agents, and the Inventors, and the faculty, employees and students of St. Jude, (collectively, the “ St. Jude Indemnitees ”), harmless from and against any Liability a St. Jude Indemnitee may be required to pay to one or more Third Parties to the extent resulting from or arising out of [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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[***].

10.04 Insurance . Novartis shall maintain in full force and effect, at its sole cost and expense, and at all times during the Term of this Agreement commercial general liability insurance, Including contractual liability, with limits of not less than [***] for bodily injury and personal injury, Including death, and property damage, and [***]. Notwithstanding the foregoing, Novartis shall maintain throughout the Term of this Agreement products/completed operations liability coverage in an amount no less than [***]. Novartis shall also maintain other policies of insurance or programs of self-insurance of the types and in the amounts customarily carried by their respective businesses to fulfill their obligations stated within this Agreement. Novartis warrants that neither a program of self-insurance nor the limits stated within its insurance policy(ies) will affect or limit its liability or indemnity obligations stated elsewhere in this Agreement or as required by law. Upon execution of this Agreement and annually thereafter upon request, Novartis shall provide the other with evidence of their liability insurance. Novartis shall evidence its general commercial and products/completed operations liability insurance to Juno using a Memorandum of Insurance (MOI) website link.

ARTICLE XI

CONFIDENTIALITY

11.01 Confidentiality . Novartis, Juno and Penn may exchange information in connection with this Agreement that they consider to be confidential, Including any reports or information provided by Novartis pursuant to Article IV, each of which Novartis considers to be confidential, (collectively, “ Confidential Information ”). Information will be treated as Confidential Information, if in written form, it is marked in writing as “confidential” at the time of disclosure, and other information disclosed orally or in non-tangible form is (x) identified by the disclosing Party as “confidential” at the time of disclosure and (y) within thirty (30) days thereafter, the disclosing Party provides a written summary of such other information marked as “confidential.” Each recipient of such information agrees to accept the disclosure of said Confidential Information and agrees to employ all reasonable efforts to maintain the Confidential Information secret and confidential, such efforts to be no less than the degree of care employed by the recipient to preserve and safeguard its own confidential information. The Confidential Information shall not be disclosed or revealed to anyone except officers, directors, employees and contractors of the recipient who (a) have a need to know the Confidential Information, (b) are subject to obligations of confidentiality and non-use substantially similar to those set forth in this Article XI, and (c) have been advised by the recipient of the confidential nature of the Confidential Information and that the Confidential Information shall be treated accordingly.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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11.02 Exceptions . The recipient’s obligations under Section 11.01 shall not extend to any part of the Confidential Information:

(a) that can be demonstrated to have been in the public domain or publicly known and readily available to the trade or the public prior to the date of the disclosure; or

(b) that can be demonstrated, from written records to have been in the recipient Party’s possession or readily available to the recipient Party from another source not under obligation of secrecy to the disclosing Party prior to the disclosure; or

(c) that becomes part of the public domain or publicly known by publication or otherwise, not due to any unauthorized act by the recipient Party; or

(d) that is demonstrated from written records to have been developed by or for the receiving Party without reference or access to Confidential Information disclosed by the disclosing Party; or

(e) that is required to be disclosed by law, government regulation or court order.

11.03 Permitted Disclosures . Each Party agrees not to disclose any of the terms of this Agreement or any of the information contained in reports pursuant to Article IV of this Agreement to any Person without the prior written consent of each of the other Parties; provided, however, that each Party shall be free to disclose, notwithstanding the prior written consent requirement set forth in Section 13.10, any such terms or information (a) to the extent that the Party is required to make such disclosure by order or regulation of a government agency, court or other tribunal having jurisdiction, except that to the extent permitted by law such Party shall not make any such disclosure (other than a filing of information or materials with the U.S. Securities and Exchange Commission or an equivalent authority in another jurisdiction or a relevant stock exchange that is made with a request for confidential treatment for any part of such disclosure for which such treatment may reasonably be expected to be granted, provided that the Party requesting confidential treatment discloses to the other Parties the substance of the request for confidential treatment prior to making the request) without first notifying each other Party and allowing the other Parties a reasonable opportunity to seek a protective order or injunctive relief from the obligation to make such disclosure, or (b) to its Affiliates, accountants, attorneys and other professional advisors, provided that such entities and/or individuals are obligated to keep such terms confidential to the same extent as said Party. All written reports provided by Novartis to Juno pursuant to this Agreement shall be Confidential Information of Novartis; provided that Juno may disclose (i) such reports to St. Jude as well as the contents of this Agreement, in each case, to comply with the St. Jude Agreement and (ii) to St. Jude any other information received by it under or in connection with this Agreement; provided that, in each case of (i) and (ii), St. Jude shall, pursuant to Section 6.4 of the Settlement Agreement, agree to be obligated to keep such disclosures confidential to the same extent as Juno under the terms of this Agreement.

 

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11.04 Survival . The confidentiality terms of this Article XI shall survive any expiration of this Agreement for [***].

ARTICLE XII

TERM AND TERMINATION

12.01 Term . This Agreement will commence on the Effective Date and, unless terminated earlier as provided in this Article XII, will remain in full force and effect and continue until there are no remaining payment obligations due under this Agreement (“ Term of this Agreement ”).

12.02 Termination for Cause . As between Juno and Novartis, if either Juno or Novartis materially breaches this Agreement, the non-breaching party may elect to give the breaching party written notice describing the alleged breach. If the breaching party has not cured such breach within [***] after receipt of such notice, the non-breaching party will be entitled, in addition to any other rights it may have under this Agreement, to terminate this Agreement effective immediately. In no event, however, shall such notice or intention to terminate be deemed to waive any rights to damages or any other remedy which the Party giving notice of breach may have as a consequence of such failure or breach. The cure period provided in this Section 12.02 will not have the effect of delaying the due date of payments required hereunder; accordingly, the failure to make full timely payments hereunder for any [***] out of [***] will be conclusively deemed not curable. In addition, if the appointed accountant in any [***] consecutive audits under Section 4.04 determines that (a) the unpaid amounts for any royalty reporting period exceeds [***] of the royalties paid by Novartis for such royalty reporting period, or (b) Novartis failed to comply with its obligations under Article IV, Juno may terminate this Agreement upon written notice. For the avoidance of doubt, and subject to this Section 12.02, breach of any provision of Article III or Article VI shall constitute material breach under this Section 12.02.

12.03 Termination by Novartis . Novartis may terminate this Agreement and the license granted herein for any reason, upon giving Juno [***] written notice. All payments made pursuant to Article III through the date of such termination shall be [***].

12.04 Insolvenc y. This Agreement may be terminated by a Party in the event that another Party, to the extent permissible under applicable and prevailing law, files or has filed against it a petition under the U.S. Bankruptcy Act, makes an assignment for the benefit of creditors, has a receiver appointed for it or a substantial part of its assets or otherwise takes advantage of any statute or law designed for relief of debtors.

12.05 Effect of Termination .

(a) Accrued Rights and Obligations . Termination of this Agreement for any reason shall not release any Party hereto from any liability which, at the time of such termination, has already accrued to the other Parties or which is attributable to a period prior to such termination, nor preclude any Party from pursuing any rights and remedies it may have hereunder or at law or in equity which accrued or are based upon any event occurring prior to such termination.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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(b) Termination of Sublicense . Upon any termination of this Agreement, the sublicense granted to Novartis, its Affiliates, and Penn in Section 2.01 shall terminate, and any sublicenses granted under Section 2.02 shall terminate concurrently.

(c) Return of Confidential Information . Upon any termination of this Agreement, each Party shall promptly return to the other Parties all Confidential Information received from the applicable other Parties (except one copy of which may be retained for archival purposes).

12.06 Survival . Articles I, IV, IX, X, XI, and XIII and Sections 2.06, 5.02, 8.04, 8.05, 12.05 and 12.06 of this Agreement shall survive termination of this Agreement for any reason.

ARTICLE XIII

MISCELLANEOUS PROVISIONS

13.01 Relationship of the Parties . Nothing in this Agreement is intended or shall be deemed to constitute or give rise to a partnership, agency, distributorship, employer-employee, joint venture or fiduciary relationship between the Parties. Each Party shall be liable for any failure by its Affiliates to comply with the restrictions, limitations, and obligations set forth in this Agreement. No Party shall permit any of its Affiliates to commit any act (Including any act or omission) that such Party is prohibited hereunder from committing directly. No Party shall incur any debts or make any commitments for the other. No Party owes any of the other Parties any fiduciary duties in connection with this Agreement. This Agreement is solely for the benefit of the Parties and no provision of this Agreement shall be deemed to confer upon any Third Parties any remedy, claim, liability, reimbursement, claim of action or other right in excess of those existing without reference to this Agreement.

13.02 Patent Prosecution and Enforcement . Novartis shall have no rights with respect to the prosecution, defense, and maintenance of the Licensed Patents (Including whether to undertake such activities), nor shall Novartis have any rights with respect to enforcing the same against actual or suspected Third Party infringers (Including whether to undertake such activities).

13.03 Severability . In the event that any provisions of this Agreement are determined to be invalid or unenforceable by a court of competent jurisdiction, the remainder of the Agreement shall remain in full force and effect without said provision. The Parties shall in good faith negotiate a substitute clause for any provision declared invalid or unenforceable, which shall most nearly approximate the intent of the Parties in entering this Agreement.

13.04 Waiver of Breach or Default . The waiver by a Party of any breach of or default under any of the provisions of this Agreement or the failure of a Party to enforce any of the provisions of this Agreement or to exercise any right hereunder shall not constitute or be construed as a waiver of any other breach or default or as a waiver of any such rights or provisions hereunder.

 

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13.05 Assignment . No Party shall assign this Agreement, or any rights or obligations of such Party, except: (a) as incident to the merger, consolidation, reorganization or acquisition of stock or assets affecting substantially all of the assets or voting control of the assigning Party; (b) to any Person to which it transfers all or substantially all of its assets related to Licensed Products; (c) to an Affiliate if the assigning Party remains liable and responsible for the performance and observance of all of the Affiliate’s duties and obligations hereunder; or (d) with the prior written consent of each other Party (which consent shall not be unreasonably withheld). A Party making an assignment shall promptly give written notice thereof to each other Party. This Agreement, and rights and obligations hereunder, shall be binding upon the successors and permitted assigns of the Parties, and the name of a Party appearing herein shall be deemed to include the names of such Party’s successor’s and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any assignment not in accordance with this Section 13.05 shall be void.

13.06 Trade Names and Trademarks . Except as otherwise provided herein, no right, expressed or implied, is granted by this Agreement to use in any manner the name “Juno” or any other trade name or trademark of Juno in connection with the performance of this Agreement or otherwise. Except as otherwise provided herein, no right, expressed or implied, is granted by this Agreement to use in any manner the name “Novartis” or any other trade name or trademark of Novartis in connection with the performance of this Agreement or otherwise. Except as otherwise provided herein, no right, expressed or implied, is granted by this Agreement to use in any manner the name “Penn” or any other trade name or trademark of Penn in connection with the performance of this Agreement or otherwise. Except as otherwise provided herein, no right, expressed or implied, is granted by this Agreement to use in any manner the name “St. Jude” or any other trade name or trademark of St. Jude in connection with the performance of this Agreement or otherwise.

13.07 Dispute Resolution . Except as otherwise expressly provided in this Agreement, any dispute, controversy or claim arising out of or in connection with or relating to this Agreement or the breach or alleged breach thereof (Including any dispute regarding arbitrability), but not including any dispute, controversy or claim concerning the patentability, validity, enforceability, or infringement of any patent, shall be finally and exclusively decided by binding arbitration by JAMS pursuant to its Comprehensive Arbitration Rules. The arbitration shall be held in Chicago, Illinois. The arbitration panel shall be comprised of three (3) independent, conflict-free arbitrators. The Parties shall endeavor to select all three (3) such arbitrators by mutual agreement within [***] of the failure of the Parties to resolve the matter. If the Parties are unable to do so, Juno shall appoint one (1) independent, conflict-free arbitrator, Novartis and Penn shall together appoint one (1) independent, conflict-free arbitrator, and a third independent, conflict-free arbitrator shall be selected and appointed by the two appointed arbitrators. If the Parties’ appointed arbitrators fail to agree on the identity of such third arbitrator within [***] from the date both Parties’ arbitrators have been appointed, then such third arbitrator shall be appointed by the appropriate administrative body of JAMS from its list of authorized arbitrators, which arbitrator shall have substantial prior experience arbitrating contract, licensing and patent disputes. The Parties shall have the right to conduct discovery as provided for

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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in the Federal Rules of Civil Procedure. All discovery shall be completed within [***] following the appointment of the arbitrators. The arbitrators’ decision and award in the arbitration shall be in writing setting forth the basis therefor and shall be rendered within [***] following the appointment of the arbitrators. The award rendered by the arbitrators shall include costs of the arbitration, reasonable attorneys’ fees, and reasonable costs for experts and other witnesses, and judgment on the award may be entered in any court having jurisdiction. To the extent permitted by law, the arbitration proceeding and arbitrator’s decision shall be confidential and the arbitrators shall issue appropriate protective orders to safeguard each Party’s confidential information. Nothing in this Agreement shall be deemed as preventing a Party from seeking temporary injunctive relief (or any other provisional remedy) from any court having jurisdiction over the Parties and the subject matter of the dispute but only to the extent necessary to protect such Party’s name, confidential information, or other similar proprietary rights, or to prevent any imminent irreparable harm. Each Party hereby consents to the personal jurisdiction and venue of any court of competent jurisdiction in the United States for purposes of entering judgment on the arbitration award.

13.08 Choice of Law . The validity, performance, construction, and effect of this Agreement and any arbitration conducted under Section 13.07 shall be governed by and interpreted in accordance with the laws of the State of New York without regard to conflict of laws principles, except that the validity, performance, construction and effect of patent-related terms of Article VI shall be governed by and interpreted in accordance with Federal Circuit law.

13.09 Notices . Any notice, request, consent or other document required or permitted to be given under this Agreement or otherwise relating to this Agreement shall be in writing and shall be deemed to have been sufficiently given if delivered in person, or sent by overnight courier or registered mail to the Party to whom it is directed at its address shown below or such other address as such Party shall have last given by notice to each other Party. Any such notice, request, delivery, approval or consent shall be deemed received on the date of hand delivery (provided that such date is a Business Day, otherwise it shall be deemed received on the next Business Day), or one (1) Business Day after dispatch by overnight courier, or five (5) Business Days after dispatch by registered mail.

If to Novartis, addressed to each of:

Novartis AG

CH-4056

Basel, Switzerland

Attn: Group General Counsel

Notices to Novartis, to each of:

Novartis Pharmaceuticals Corporation

One Health Plaza

East Hanover, New Jersey 07936

Attention: General Counsel

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

25


Execution Copy

 

Novartis Institutes of Biomedical Research, Inc.

250 Massachusetts Avenue

Cambridge, Massachusetts 02139

Attention: General Counsel

The Trustees of the University of Pennsylvania

133 South 36th Street, Suite 300

Philadelphia, PA 19104

Attention: General Counsel

With a copy to (which alone shall not constitute notice):

Morgan, Lewis & Bockius LLP

1701 Market Street

Philadelphia, PA 19103

Attention: Eric Kraeutler, Esq.

If to Juno, addressed to:

Juno Therapeutics, Inc.

307 Westlake Avenue North, Suite 300

Seattle, WA 98109

United States of America

Attn: General Counsel

13.10 Publicity . Other than the press releases attached hereto as Exhibit 13.10(a) and Exhibit 13.10(b) , no Party shall issue any press release or other publicity material or make any public representation that refers to the existence of this Agreement without the prior written consent of the each of the other Parties (which consent shall not be unreasonably withheld or delayed), except with respect to the financial terms of the Agreement, which shall not be disclosed without the prior written consent of the each of the other Parties (which consent may be withheld for any reason or no reason).

13.11 Third Party Beneficiary . Novartis and Penn hereby acknowledge that, pursuant to Section 2.2 of the St. Jude License Agreement, St. Jude is an intended Third Party beneficiary of this Agreement that has the right to directly enforce against Novartis and Penn the terms of this Agreement, subject to the following limitations: St. Jude shall not exercise any of its rights as a Third Party beneficiary granted to it unless: (a) St. Jude has notified Juno in writing of the obligation of Novartis and Penn sought to be enforced (the “ Obligation ”); (b) the Obligation has as its origin a requirement of the St. Jude Agreement; (c) Juno has failed to commence and continue to pursue reasonable steps within [***] after receiving notice from St. Jude pursuant to clause (a) above to enforce the Obligation, or Novartis or Penn has not fulfilled the Obligation within [***] after notice to Juno pursuant to clause (a) above; and (d) at the time St. Jude asserts its rights as a Third Party beneficiary against Novartis and Penn, St. Jude shall have a reasonable basis for believing that Novartis or Penn is in breach of the Obligation sought to be enforced.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

26


Execution Copy

 

13.12 No Patent Marking . Juno acknowledges and agrees that Novartis is not required to mark the Licensed Product(s) sold by Novartis or its Affiliates or its Permitted Sublicensees with the number of the applicable United States granted patent(s) licensed hereunder; provided that Novartis and its Affiliates and Permitted Sublicensees will be obligated to mark Licensed Product(s) with the number of the applicable United States granted patent(s) licensed hereunder if such Licensed Product(s) are marked by other applicable patent(s) not licensed hereunder. To the extent that any Licensed Patent is marked in accordance with this provision, such marking is not an admission that the Licensed Patent is valid and enforceable, or would be infringed by a Licensed Product in the absence of the license provided under this Agreement.

13.13 Compliance with Laws . In all activities undertaken pursuant to this Agreement, Juno and Novartis covenant and agree that each will in all material respects comply with such federal, state and local laws and statutes, as may be in effect at the time of performance and all valid rules, regulations and orders thereof regulating such activities.

13.14 Construction . Each of Novartis, Juno, and Penn have been represented and advised by legal counsel in connection with the negotiation, drafting, and execution of this Agreement, and each of such parties, through their respective counsel, have participated in the drafting of this Agreement and accordingly that this Agreement shall not be deemed to have been drafted by any one of such parties and will be construed accordingly.

13.15 Entire Agreement . This Agreement Including the Settlement Agreement incorporated by reference pursuant to Section 5.01, constitutes and contains the entire understanding and agreement of Novartis, Juno, and Penn with respect to the subject matter hereof and cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether verbal or written, between such parties with respect to subject matter hereof. No waiver, modification, or amendment of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized representative of each of Novartis, Juno, and Penn.

13.16 Counterparts . This Agreement may be executed simultaneously in one or more counterparts (Including in the form of a PDF or other electronic document), each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

(Signature Page Follows)

 

27


IN WITNESS WHEREOF, Juno, Novartis and Penn, have caused this Agreement to be executed by their duly authorized representatives.

JUNO THERAPEUTICS, INC.

 

/s/ Bernard J. Cassidy

Name:  

Bernard J. Cassidy

Title:  

General Counsel & Secretary

Date:  

April 4, 2015

NOVARTIS INSTITUTES OF BIOMEDICAL RESEARCH, INC.

 

/s/ Scott A. Brown

Name:  

Scott A. Brown

Title:  

VP, General Counsel

Date:  

April 3, 2015

THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA

 

/s/ John S. Swartley

Name:  

John S. Swartley, Ph.D.

Title:  

Associate Vice Provost for Research, Executive Director, PCI

Date:  

April 3, 2015

[SIGNATURE PAGE TO NON-EXCLUSIVE SUBLICENSE AGREEMENT]


EXHIBIT 1.14

LICENSED PATENTS

U.S. Patent No.: 8,399,645

[***]

[***]

[***]

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


EXHIBIT 1.28

ST. JUDE AGREEMENT (REDACTED)

(see attachment)


EXCLUSIVE LICENSE AGREEMENT

BETWEEN

ST. JUDE CHILDREN’S RESEARCH HOSPITAL, INC.

&

JUNO THERAPEUTICS, INC.

ST. JUDE File No.: SJ-03-0018


LICENSE AGREEMENT

THIS LICENSE AGREEMENT (the “AGREEMENT”) is entered into as of December 3, 2013 (the “EFFECTIVE DATE”) by and between ST. JUDE CHILDREN’S RESEARCH HOSPITAL, INC., a Tennessee not-for-profit corporation having an address at 262 Danny Thomas Place, Memphis, TN 38105 (“ST. JUDE” or “LICENSOR”), and JUNO THERAPEUTICS, INC., a Delaware corporation, having an address at 8725 W. Higgins Road, Suite 290, Chicago, IL 60631 (“COMPANY”) (ST. JUDE and COMPANY hereinafter each referred to as a “PARTY”, or collectively referred to as the “PARTIES”) with respect to the following:

RECITALS

WHEREAS, as a center for research and education, ST. JUDE is interested in licensing PATENT RIGHTS (hereinafter defined) in a manner that will benefit the public by facilitating the development and distribution of useful products and the utilization of new processes, but is without capacity to commercially develop, manufacture, and distribute any such products or processes; and

WHEREAS, a valuable invention(s) titled “Chimeric Receptors with 4-1BB Stimulatory Signaling Domain” (ST. JUDE File No.: SJ-03-0018) was developed during the course of research conducted by Drs. Dario Campana and Chihaya Imai while employed by ST. JUDE (all hereinafter referred to as “INVENTORS” and each individually referred to as an “INVENTOR”); and

WHEREAS, LICENSOR has acquired through assignment by each of the INVENTORS all rights, title and interest, with the exception of certain retained rights by the United States Government, in their interest in said valuable inventions; and

WHEREAS, COMPANY desires to obtain certain rights in such inventions as herein provided and to commercially develop, manufacture, use and/or distribute products based upon or embodying said valuable inventions throughout the world; and

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

ARTICLE 1

DEFINITIONS

All references to particular Exhibits, Articles or Paragraphs shall mean the Exhibits to, and Paragraphs and Articles of, this AGREEMENT, unless otherwise specified. For the purposes of this AGREEMENT and the Exhibits hereto, the following words and phrases shall have the following meanings:

 

[ ### ] = REDACTED INFORMATION


1.1 “AFFILIATED COMPANY” as used herein in either singular or plural shall mean any corporation, company, partnership, joint venture or other entity, which controls, is controlled by or is under common control with COMPANY. For purposes of this Paragraph 1.1, control shall mean the direct or indirect ownership of at least fifty- percent (50%) of the voting or economic interest in said entity. Any AFFILIATED COMPANY that is exercising rights under this AGREEMENT shall provide a written acknowledgement to LICENSOR that they are bound by, and agree to abide by, the terms of this AGREEMENT.

1.2 “BLA” shall mean a Biologics License Application, as defined in the U.S. Federal Food, Drug, and Cosmetics Act, as amended, and the regulations promulgated thereunder, any alternate market approval application including without limitation a New Drug Application or 510k application, and any corresponding supranational, foreign or domestic equivalent marketing authorization application, registration or certification, necessary to market a LICENSED PRODUCT.

1.3 “EFFECTIVE DATE” of this LICENSE AGREEMENT shall mean the date set forth above.

1.4 “LICENSED FIELD” shall mean all therapeutic, diagnostic, preventative and palliative uses.

1.5 “LICENSED PRODUCT(S)” as used herein in either singular or plural shall mean, on a country by country basis, any material, cell, composition, drug, or other product, the manufacture, use, importation, offer for sale or sale of which would constitute, but for the license granted to COMPANY pursuant to this AGREEMENT, an infringement of a VALID CLAIM of PATENT RIGHTS in that country (infringement shall include, but is not limited to, direct, contributory, or inducement to infringe), assuming, for purposes of determining coverage by this definition, that all pending claims within the PATENT RIGHTS have issued. For the purpose of determining diligence and achievement of clinical development milestones, a product shall fall within this definition even if the exception set forth in 35 U.S.C. § 271(e)(1) may apply.

1.6 “LICENSED SERVICES” shall mean, on a country-by-country basis, any service performed for or on behalf of a third party on a fee-for-service or other basis, the performance of which in the country in question would (without the license granted under the AGREEMENT) infringe at least one VALID CLAIM in that country.

1.7 “NET SALES” shall mean the gross amount billed by COMPANY, AFFILIATES or SUBLICENSEES for LICENSED PRODUCTS or LICENSED SERVICES, less the following:

(a) customary trade, quantity, or cash discounts to the extent actually allowed and taken;

(b) amounts repaid or credited by reason of rejection or return of LICENSED PRODUCTS not replaced or LICENSED SERVICES not re-performed;

 

[ ### ] = REDACTED INFORMATION


(c) to the extent separately stated on purchase orders, invoices, or other documents of sale, any taxes or other governmental charges levied on the production, sale, transportation, delivery, or use of a LICENSED PRODUCT or performance of a LICENSED SERVICE, which is paid by or on behalf of COMPANY or AFFILIATES; and

(d) outbound transportation costs prepaid or allowed and costs of insurance in transit.

No deductions shall be made for [###]. NET SALES shall occur on the date of billing for a LICENSED PRODUCT or LICENSED SERVICE.

Customary distribution of free samples of LICENSED PRODUCT or related performance of LICENSED SERVICES by COMPANY or AFFILIATES that constitute less than [###] of the total annual distribution of LICENSE PRODUCTS and LICENSED SERVICES shall not be included in any calculation of NET SALES.

1.8 “PATENT RIGHTS” shall mean (a) the patent and patent applications listed on Exhibit A hereto, (b) any other patent or patent application that claims priority to, or common priority with, or is a divisional, continuation, reissue, renewal, reexamination, substitution or extension of any patent or patent application identified in (a); (c) any patents subsequently issuing on any patent application identified in (a) or (b), including any reissues, renewals, reexaminations, substitutions or extensions thereof; (d) any claim of a continuation-in-part application or patent (including any reissues, renewals, reexaminations, substitutions or extensions thereof) that is entitled to the priority date of at least one of the patents or patent applications identified in (a), (b) or (c); (e) any foreign counterpart (including PCTs) of any patent or patent application identified in (a), (b), (c) or (d); and (f) any supplementary protection certificates, pediatric exclusivity periods, any other patent term extensions and exclusivity periods and the like of any patents and patent applications identified in (a) through (e). PATENT RIGHTS shall also include any patent applications or patents filed by the Trustees of the University of Pennsylvania (“ Third Party Patent Rights ”) claiming, in whole or part, subject matter disclosed in any of the foregoing patent applications and/or patents to the extent that the inventorship of such Third Party Patent Rights includes, or is corrected to include, one or more of the inventors named in any of the PATENT RIGHTS described in subParagraphs (a)- (f) above. Specifically excluded from PATENT RIGHTS are U.S. Patent Nos. [###] and [###], and any other patent or patent application that claims priority to, or common priority with, or is a divisional, continuation, re-issue, renewal, reexamination, substitution or extension of any patent or patent application identified in clause (a) above that contains only claims directed to the [###].

1.9 “PHASE I CLINICAL TRIAL” shall mean a human clinical trial, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients as required in 21 C.F.R. §312, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States.

1.10 “PHASE II CLINICAL TRIAL” shall mean (i) a human clinical trial, for which a primary endpoint is a preliminary determination of efficacy or dose ranges in patients with the disease target being studied as required in 21 C.F.R. §312.21(b), as may be amended from time to time, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States, or (ii) a combined Phase I and Phase II Clinical Trial which [###], or any Phase III Clinical Trial performed in lieu of a Phase II study.

 

[ ### ] = REDACTED INFORMATION


1.11 “PHASE III CLINICAL TRIAL” shall mean a human clinical trial, the principal purpose of which is to establish safety and efficacy in patients with the disease target being studied as required in 21 C.F.R. §312, or similar clinical study prescribed by the regulatory authorities in a country other than the United States. A Phase III Clinical Trial shall also include any other human clinical trial intended as a pivotal (a Phase II trial that provides evidence for a drug marketing approval) study, whether or not such study is a traditional Phase III study.

1.12 “SUBLICENSE” means any agreement or multiple agreements with a third party which is not an AFFILIATED COMPANY in which COMPANY:

(a) Grants rights in, to or in respect of any of the PATENT RIGHTS;

(b) Grants the right to make, use, offer for sale, sell or import a LICENSED PRODUCT, or to provide a LICENSED SERVICE;

(c) Agrees not to assert the PATENT RIGHTS or agrees not to sue, seek damages or seek injunctive relief for the practice of same;

(d) Assigns or otherwise transfers this AGREEMENT other than as permitted under Article 10.9 herein below and provided that LICENSOR has elected to treat such assignment or transfer as a SUBLICENSE; or

(e) Is under an obligation to do any of the foregoing, or to forbear from offering to do or doing any of the foregoing with any other entity.

The term SUBLICENSE as defined above includes without limitation any agreement that provides a license, option, right of first refusal or negotiation, or covenant not to sue, regarding the PATENT RIGHTS.

1.13 “SUBLICENSEE(S)” as used herein in either singular or plural shall mean any person or entity to which COMPANY has granted a SUBLICENSE.

1.14 “SUBLICENSE CONSIDERATION” shall mean consideration of any kind received by the COMPANY from a SUBLICENSEE(S) for the grant of a SUBLICENSE under or in respect of this AGREEMENT, including, but not limited to, license issue fees, option fees and other licensing fees, milestone payments, minimum annual royalties, license maintenance fees, success fees, and other payments of any kind whatsoever. However, not included in such SUBLICENSE CONSIDERATION are:

(a) [###],

(b) [###],

(c) [###], and

(d) [###].

To the extent that third party rights are sublicensed in combination with the PATENT RIGHTS, the SUBLICENSE CONSIDERATION allocated to the PATENT RIGHTS shall be determined by COMPANY, in consultation with LICENSOR, in good faith with respect to the PATENT RIGHTS and such other rights.

 

[ ### ] = REDACTED INFORMATION


1.15 “ VALID CLAIM ” as used herein in either singular or plural shall mean a claim of any (i) issued and unexpired patent included within the PATENT RIGHTS unless the claim has been held unenforceable or invalid by the final, un-reversed, and un-appealable decision of a court or other government body of competent jurisdiction, has been irretrievably abandoned or disclaimed, or has otherwise been finally admitted or determined to be invalid, unpatentable or unenforceable, whether through reissue, reexamination, disclaimer or otherwise, or (ii) a pending claim of a patent application within the PATENT RIGHTS to the extent the claim continues to be prosecuted in good faith and has not been cancelled, withdrawn, abandoned or finally disallowed without the possibility of appeal or re-filing of such application.

ARTICLE 2

LICENSE GRANT

2.1 Grant. Subject to the terms and conditions of this AGREEMENT, LICENSOR hereby grants to COMPANY (i) an exclusive license to develop, make, have made, use, import, offer for sale, sell, and have sold the LICENSED PRODUCT(S) and LICENSED SERVICES worldwide under the PATENT RIGHTS in the LICENSED FIELD. This license grant shall apply to the COMPANY and any AFFILIATED COMPANY, except that any AFFILIATED COMPANY shall not have the right to sublicense others as set forth in Paragraph 2.2 below. If any AFFILIATED COMPANY exercises rights under this AGREEMENT, such AFFILIATED COMPANY shall be bound by all terms and conditions of this AGREEMENT, including, but not limited to, indemnity and insurance provisions and royalty and other payment provisions, which shall apply to the exercise of the rights, to the same extent as would apply had this AGREEMENT been directly between LICENSOR and the AFFILIATED COMPANY. In addition, COMPANY shall remain fully liable to LICENSOR for all acts, omissions and obligations of AFFILIATED COMPANY such that acts, omissions and obligations of the AFFILIATED COMPANY shall be considered acts, omissions and obligations of the COMPANY. This exclusive license grant is subject to (i) rights retained by the United States Government, if any, in accordance with the Bayh-Dole Act of 1980 (established by P.L. 96-517 and amended by P.L. 98-620, codified at 35 USC § 200 et. seq. and implemented according to 37 CFR Part 401), and (ii) the retained rights of LICENSOR to make, have made and use the inventions claimed in the PATENT RIGHTS for LICENSOR’S internal, non-commercial research purposes. For the avoidance of doubt, LICENSOR shall continue to have the right to distribute its biological materials embodying PATENT RIGHTS for non-profit, academic research use under the material transfer agreements (MTAs) found in Exhibits E and F.

 

[ ### ] = REDACTED INFORMATION


If LICENSOR transfers to a third party any Materials (as defined in the MTAs) covered in whole or part by the PATENT RIGHTS licensed to COMPANY, and is notified by any recipient of any inventions made with the use of such transferred Materials, including without limitation, any patent applications disclosing or claiming any such inventions, LICENSOR shall promptly notify COMPANY, providing any and all information that LICENSOR has regarding such inventions and/or patent applications. At the request of COMPANY, LICENSOR shall negotiate in good faith the terms of a non-exclusive, royalty-bearing worldwide license, with the right to sublicense to COMPANY, with regard to such inventions and/or patent applications to make, have made, use, offer for sale and sell products. LICENSOR shall consult with COMPANY regarding acceptable financial and other terms for any such license and not enter into any agreement with such third party except on terms acceptable to COMPANY. COMPANY shall be responsible for the payment to LICENSOR [###] to the third party for such a license; provided, in no event shall the amount payable to LICENSOR for such a license be more than LICENSOR owes to the third party for any such license. In the event that LICENSOR enters into any such license, the parties shall promptly enter into a written amendment to this AGREEMENT consistent with this paragraph.

2.2 Sublicense. COMPANY may grant SUBLICENSES under the PATENT RIGHTS to third parties pursuant to this AGREEMENT, subject to the terms and conditions of this Paragraph 2.2. COMPANY shall provide LICENSOR with an unredacted copy of each SUBLICENSE between COMPANY and a third party for the grant of rights under the PATENT RIGHTS within thirty (30) days of its execution. Each SUBLICENSE shall: (a) be consistent with the terms, conditions and limitations of this AGREEMENT, (b) name LICENSOR as an intended third party beneficiary of the obligations of SUBLICENSEE without imposition of obligation or liability on the part of LICENSOR or the INVENTORS to the SUBLICENSEE, and (c) [###]. Each SUBLICENSE furnished to LICENSOR by COMPANY shall be the Confidential Information of COMPANY. COMPANY shall (i) be and remain responsible for the performance by such SUBLICENSEE with the terms of this AGREEMENT, and any action by a SUBLICENSEE that would, if conducted by COMPANY be a breach of this AGREEMENT, shall be deemed a breach of this AGREEMENT by COMPANY, and (ii) ascertain, calculate, audit and collect all royalties that become payable by such SUBLICENSEE hereunder and take appropriate enforcement action against such SUBLICENSEE for any failure to pay or to properly calculate payments. LICENSOR shall not exercise any of its rights as a third party beneficiary granted to it pursuant to clause (b) above unless: (w) LICENSOR has notified COMPANY in writing of the obligation of SUBLICENSEE sought to be enforced (the “Obligation”); (x) the Obligation has as its origin a requirement of this AGREEMENT; (y) COMPANY has failed to commence and continue to pursue reasonable steps within thirty (30) days of notice from LICENSOR pursuant to clause (w) above to enforce the Obligation or SUBLICENSEE has not fulfilled the Obligation within ninety (90) days of notice to COMPANY pursuant to clause (w) above, and (z) at the time LICENSOR asserts its rights as a third party beneficiary against SUBLICENSEE, LICENSOR shall have a reasonable basis for believing that SUBLICENSEE is in breach of the Obligation sought to be enforced.

 

[ ### ] = REDACTED INFORMATION


2.3 Government Rights. The United States Government has acquired a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the inventions described in PATENT RIGHTS throughout the world. The rights granted herein are additionally subject to, and expressly conditioned upon compliance with (i) the provisions of the Bayh-Dole Act, 35 USC § 200 et seq, and (ii) other rights acquired, or requirements imposed, by the United States government under the grant/contract award terms and the laws and regulations applicable to the grant/contract award under which the inventions were made.

2.4 Duties of the Parties. LICENSOR is an institute of research and education and not a commercial organization. Therefore, LICENSOR has no ability to evaluate the commercial potential of any PATENT RIGHTS, LICENSED PRODUCT or LICENSED SERVICES or other license or rights granted in this AGREEMENT. It is therefore incumbent upon COMPANY to evaluate the rights, products and services in question, to examine the materials and information provided by LICENSOR and to determine for itself the validity of any PATENT RIGHTS, its freedom to operate, and the value of any LICENSED PRODUCTS or LICENSED SERVICES or other rights granted.

ARTICLE 3

FEES, ROYALTIES, & PAYMENTS

3.1 License Fee. COMPANY shall pay to LICENSOR within [###] of the EFFECTIVE DATE a license fee as set forth in Exhibit B . LICENSOR will not submit an invoice for the license fee, which is nonrefundable and shall not be credited against royalties or other fees. Time is of the essence with respect to payment of this fee. This AGREEMENT shall be null and void ab initio if the License Fee is not received within [###] of the EFFECTIVE DATE.

3.2 Minimum Annual Royalties. COMPANY shall pay to LICENSOR minimum annual royalties as set forth in Exhibit B . These minimum annual royalties shall be due [###] on January 1 following each anniversary of the EFFECTIVE DATE beginning with the first anniversary, and shall be payable within [###] thereafter. For clarity, the first minimum annual royalty payment, for the calendar year 2014, shall be due on January 1, 2015, and payable no later than [###]. Running royalties accrued under Paragraph 3.3 and paid to LICENSOR for a given calendar year shall be credited against the minimum annual royalties due for such calendar year. For example, running royalties accrued under and paid to LICENSOR during calendar year 2015 shall be credited only against the minimum annual royalty payment due and payable no later than [###].

3.3 Running Royalties. COMPANY shall pay to LICENSOR a running royalty as set forth in Exhibit B , for LICENSED PRODUCT(S) and LICENSED SERVICE sold by COMPANY, AFFILIATED COMPANIES and/or SUBLICENSEE(S), based on NET SALES for the Term of this AGREEMENT. Such payments shall be due semi-annually (June 30 th and December 31 st ) and shall be payable within [###] of the end of each half year. Such royalties shall [###] based on [###] related to LICENSED PRODUCTS and LICENSED SERVICES.

 

[ ### ] = REDACTED INFORMATION


Notwithstanding anything to the contrary in this AGREEMENT, in order to insure LICENSOR the full royalty and other payments contemplated hereunder, COMPANY agrees that in the event any LICENSED PRODUCT(S) or LICENSED SERVICES shall be sold to a corporation, firm or association (the “PURCHASER”) with which COMPANY shall have any agreement, understanding or arrangement with respect to consideration (such as, among other things, an option to purchase stock or actual stock ownership, or an arrangement involving division of profits or special rebates or allowances) received by COMPANY with respect to sale of such LICENSED PRODUCT(S) or LICENSED SERVICES, the royalties to be paid hereunder to LICENSOR for such LICENSED PRODUCT(S) or LICENSED SERVICES shall be based upon the greater of: 1) the [###] of the LICENSED PRODUCT(S) or LICENSED SERVICES as of the date that COMPANY receives such consideration from such PURCHASER, or 2) the [###] of LICENSED PRODUCT(S) or LICENSED SERVICES paid by the PURCHASER.

3.4 SUBLICENSE CONSIDERATION. In addition to the running royalty as set forth under Paragraph 3.3, COMPANY shall pay to LICENSOR, as set forth on Exhibit B a percentage of SUBLICENSE CONSIDERATION. Any SUBLICENSE CONSIDERATION payment due to LICENSOR shall be due within [###] of the end of the six (6) month calendar period in which any SUBLICENSE CONSIDERATION was received, [###]. Such payment shall be accompanied by a detailed written report setting forth the nature and scope of the rights granted, and the total consideration received. COMPANY shall not directly or indirectly accept [###].

3.5 Milestone Payments. COMPANY shall pay to LICENSOR the milestone payments as set forth in Exhibit C for the term of this AGREEMENT. For the avoidance of doubt, clinical trials of LICENSED PRODUCT conducted by COMPANY or on its behalf by other entities with respect to which COMPANY owns or has the right to use the data resulting therefrom and has an obligation to report such results to the regulatory authority having jurisdiction over the conduct of human clinical trials and the approval of products for human use in the jurisdiction where such clinical trials are conducted, including ongoing clinical trials at Fred Hutchinson Cancer Research Center sponsored by COMPANY, shall be considered for determining achievement of milestones. All non-US taxes (excluding any taxes based on LICENSOR’S income) related to milestone payments shall be paid by COMPANY and shall not be deducted from payments due to LICENSOR.

3.6 Patent Prosecution Reimbursement. COMPANY will reimburse LICENSOR, within thirty (30) days of the EFFECTIVE DATE the amount of [###] for costs associated with the preparation, filing, maintenance, and prosecution of PATENT RIGHTS incurred by LICENSOR on or before the EFFECTIVE DATE. In accordance with Paragraph 4.1 below, COMPANY will reimburse LICENSOR, within [###] of the receipt of an invoice from LICENSOR, for all reasonable costs associated with the preparation, filing, maintenance, and prosecution of PATENT RIGHTS in the LICENSED FIELD incurred by LICENSOR subsequent to the EFFECTIVE DATE.

3.7 Form of Payment. All payments under this AGREEMENT shall be made in U.S. Dollars. Checks are to be made payable to “St. Jude Children’s Research Hospital”. Wire transfers may be made using the following information:

 

[ ### ] = REDACTED INFORMATION


Acct Name: St. Jude Children’s Research Hospital, Master Concentration Account

Acct Number: [###]

Bank Name: First Tennessee Bank

Bank Swift: FTNMUS44

Bank ABA #: 084-000026

Bank Address: Post Office Box 84

Memphis, TN 38101

USA

COMPANY shall be responsible for any and all costs associated with wire transfers and shall include a reference to this AGREEMENT in any wire transfer payment. Payments made by check should be sent to the following address:

St. Jude Children’s Research Hospital

P.O. Box 1000, Department # 516

Memphis, TN 38148-0516

3.8 Late Payments. In the event that any payment due hereunder is not made when payable, the payment shall accrue interest beginning on the tenth day following the due date thereof, calculated at the rate of [###] per month from the date said payment is due, provided however, that in no event shall said annual interest rate exceed the maximum legal interest rate for corporations. Each such payment when made shall be accompanied by all interest so accrued. Said interest and the payment and acceptance thereof shall not negate or waive the right of LICENSOR to seek any other remedy, legal or equitable, to which it may be entitled because of the delinquency of any payment including, but not limited to termination of this AGREEMENT as set forth in Article 9.

3.9 Withholding Taxes. Notwithstanding that LICENSOR is a tax-exempt entity under the United States Internal Revenue Code, as amended, in the event that payments due to LICENSOR in respect of NET SALES in jurisdictions other than the United States are subject to required withholding, such taxes shall be deducted by COMPANY (or its SUBLICENSEES) from such payment prior to remittance, and shall be paid over to the relevant taxing authorities when due. COMPANY shall promptly furnish LICENSOR evidence of any such taxes withheld and of payment thereof, and shall render reasonable assistance to LICENSOR in connection with its invocation of available procedures to seek refund of such payments.

ARTICLE 4

PATENT PROSECUTION, MAINTENANCE, & INFRINGEMENT

4.1 Prosecution & Maintenance. LICENSOR [###] shall be the PARTY responsible for the filing, prosecution and maintenance of patents and patent applications specified under PATENT RIGHTS and, subject to the terms and conditions of this AGREEMENT, COMPANY shall be licensed thereunder. Title to all such patents and patent applications shall reside in LICENSOR. LICENSOR shall have full and complete control over all patent matters in connection therewith under the PATENT RIGHTS, provided however, that LICENSOR shall

 

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(a) cause its patent counsel, reasonably acceptable to COMPANY, to timely copy COMPANY on all official actions and written correspondence with any patent office, and (b) allow COMPANY and/or counsel appointed by COMPANY an opportunity and reasonably sufficient time to comment and advise LICENSOR with respect thereto. The exercise of such right by COMPANY shall not interfere with the timely filing or submission of any document with, or response to, any official patent office. LICENSOR shall consider in good faith and reasonably incorporate all comments and advice from COMPANY, to the extent that they would tend to cover in more specificity, support or expand the scope of rights sought. By concurrent written notification to LICENSOR and its patent counsel at least [###] in advance of any filing or response deadline, or fee due date, COMPANY may elect not to have a patent application filed in any particular country or not to pay expenses associated with prosecuting or maintaining any patent application or patent within PATENT RIGHTS, provided that COMPANY pays for [###] incurred up to LICENSOR’S receipt of such notification. Failure to provide such notification can be considered by LICENSOR to be COMPANY’s authorization to proceed [###]. Upon such notification, at LICENSOR’S own expense, LICENSOR may file, prosecute, and/or maintain such patent applications or patent within the PATENT RIGHTS with respect to which COMPANY has made the foregoing decision(s) (collectively, the “COMPANY-DECLINED PATENTS”), and any rights or license granted hereunder held by COMPANY, AFFILIATED COMPANIES or SUBLICENSEE(S) relating to COMPANY-DECLINED PATENTS shall terminate.

4.2 Notification. Each PARTY will notify the other promptly in writing when any infringement by a third party is uncovered or suspected.

4.3 Infringement.

a. General. Except as is set forth in Paragraph 4.3b, COMPANY shall have the first right to conduct and control, [###], all patent litigation relating to the PATENT RIGHTS during the Term, including the first right to enforce any patent within PATENT RIGHTS against any infringement or alleged infringement thereof, and shall at all times keep LICENSOR informed as to the status of all such litigation. Before COMPANY may commence an action with respect to any infringement of the PATENT RIGHTS, it must obtain the consent of LICENSOR, such consent not to be unreasonably withheld. Thereafter, COMPANY may, in its sole discretion and at its own expense, may institute suit against any such infringer or alleged infringer and control and defend such suit in a manner consistent with the terms and provisions hereof and recover any damages, awards or settlements resulting therefrom, to be shared by COMPANY and LICENSOR in the manner set forth below. However, no settlement, consent judgment or other voluntary final disposition of the suit may be entered into without the prior written consent of LICENSOR. LICENSOR shall not unreasonably withhold consent of any settlement, consent judgment or other voluntary final disposition of suit that does not admit the invalidity of any patent within PATENT RIGHTS and which does not purport to admit any fault or wrongdoing on the part of LICENSOR. LICENSOR shall reasonably cooperate in any such litigation, [###] including by joining as a party if required by applicable law.

 

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If COMPANY elects not to enforce any patent within the PATENT RIGHTS, then it shall so notify LICENSOR in writing within [###] of receiving notice that an infringement or suspected infringement exists. LICENSOR may, in its sole judgment and at its own expense, take steps to enforce any patent and commence, control, settle, and defend any such suit in a manner consistent with the terms and provisions hereof, and recover any damages, awards or settlements resulting therefrom, to be shared by COMPANY and LICENSOR in the manner set forth below. At LICENSOR’s request, COMPANY shall reasonably cooperate with any such litigation, at LICENSOR’s expense.

b. [###]

c. Prospective Patent Litigation. With respect to any litigation controlled by COMPANY pursuant to Paragraph 4.3a, COMPANY shall at all times keep LICENSOR informed as to the status thereof and shall (a) cause its litigation counsel, which counsel shall be reasonably acceptable to LICENSOR, to timely copy LICENSOR on all official actions and written correspondence, and (b) allow LICENSOR and counsel appointed by LICENSOR an opportunity and reasonably sufficient time to comment and advise COMPANY with respect thereto, [###]; provided that [###] must be reasonable and reflect that COMPANY is controlling the conduct of such litigation. COMPANY, in responding to the comments and advice of LICENSOR, shall give careful consideration to the views of LICENSOR and to potential effects on LICENSOR’S interests under this AGREEMENT and to potential effects on the public interest in any such action. However, no settlement, consent judgment or other voluntary final disposition of the suit may be entered into without the prior written consent of LICENSOR. LICENSOR shall not unreasonably withhold consent of any settlement, consent judgment or other voluntary final disposition of suit that does not admit the invalidity of any patent within PATENT RIGHTS and which does not purport to admit any fault or wrongdoing on the part of LICENSOR. LICENSOR shall cooperate fully with COMPANY in connection with any litigation related to PATENT RIGHTS, [###]. Any recovery obtained as a result of such litigation shall (i) first, go to reimburse the PARTY controlling the litigation for its out of pocket costs in connection with such litigation; (ii) second, from any damages awarded other than for willful infringement, LICENSOR shall receive the equivalent of [###] based on the [###] or [###] (i.e., an amount equal to [###]), and (iii) any damages awarded for willful infringement shall go [###] percent ([###]%) to the PARTY controlling the litigation and [###] percent ([###]%) shall go to the other PARTY.

ARTICLE 5

OBLIGATIONS OF THE PARTIES

5.1 Reports. COMPANY shall provide to LICENSOR the following written reports, which reports shall be Confidential Information of COMPANY, according to the following schedules.

(a) COMPANY shall provide semi-annual royalty reports, substantially in the format of Exhibit D , or as may be otherwise agreed by the parties in writing and due within [###] of the end of each calendar half year following the first commercial sale of a LICENSED PRODUCT. Royalty Reports shall disclose the amount of [###]. Payment of any such royalties due shall accompany such Royalty Reports.

 

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(b) Until such time as COMPANY, an AFFILIATED COMPANY or a SUBLICENSEE(S) has achieved a first commercial sale of a LICENSED PRODUCT, or received FDA market approval, COMPANY shall provide annual diligence reports, due within [###] of the end of every December following the EFFECTIVE DATE of this AGREEMENT. These diligence reports shall describe COMPANY’s, AFFILIATED COMPANY’s or any SUBLICENSEE(S)’s technical and other efforts towards meeting its obligations under the terms of this AGREEMENT, particularly its progress toward achieving the developmental milestones set forth in Exhibit C and shall explain any delays experienced in achieving such milestones relative to the projected dates for achievement set forth in Exhibit C .

(c) COMPANY shall further provide in conjunction with the reports due pursuant to Paragraphs 5.1(a) and 5.1(b), the following information:

[###]

5.2 Records. COMPANY shall make and retain, for a period of [###] following the period of each report required by Paragraph 5.1(a), true, complete and accurate records, files and books of account containing all the data reasonably required for the full computation and verification of sales and other information required in Paragraph 5.1(a). Such books and records shall be in accordance with generally accepted accounting principles consistently applied. COMPANY shall permit the inspection of such records, files and books of account by LICENSOR’S agent (the “Auditor”), which Auditor shall be a nationally recognized auditor acceptable to COMPANY, such acceptance not to be unreasonably withheld, and subject to obligations of confidentiality and nonuse owed to LICENSOR consistent with the confidentiality and non-use obligations set forth in this Agreement. Any such inspection shall occur during regular business hours upon [###] written notice to COMPANY. Such inspection shall not be made more than once each calendar year. All costs of such inspection shall be paid by LICENSOR, provided that if any such inspection shall reveal that an error or omission has been made resulting in an underpayment equal to [###], the costs of such inspection shall be borne by COMPANY. As a condition to entering into any agreement, COMPANY shall include in any agreement with its AFFILIATED COMPANIES or its SUBLICENSEE(S) which permits such party to make, use, offer to sell, sell or import the LICENSED PRODUCT(S) or LICENSED SERVICES, a provision requiring such party to retain records of sales of LICENSED PRODUCT(S) or LICENSED SERVICES and other information as required in Paragraphs 5.1(a) and this Paragraph 5.2 and permit the Auditor to inspect such records as required by this Paragraph 5.2. All information and records made available to the Auditor pursuant to this Paragraph 5.2 shall be deemed to be and treated as Confidential Information of COMPANY pursuant to Article 8.

5.3 Commercially Reasonable Efforts. COMPANY shall exercise commercially reasonable efforts to develop and to introduce the LICENSED PRODUCT(S) and/or LICENSED SERVICES into the commercial market as soon as practicable, consistent with sound and reasonable business practice and judgment; thereafter, until the expiration or termination of this AGREEMENT, COMPANY shall endeavor to keep LICENSED PRODUCT(S) and LICENSED SERVICES reasonably available to the public. COMPANY shall also exercise commercially reasonable efforts to develop LICENSED PRODUCT(S) suitable for different indications within the LICENSED FIELD, so that the PATENT RIGHTS can be commercialized as broadly and as speedily as good scientific, clinical and business judgment would deem possible. Development Milestones for the LICENSED PRODUCTS are detailed in Exhibit C .

 

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COMPANY shall notify LICENSOR well in advance if COMPANY believes that it will fail to achieve the Development Milestones in the expected timeframe as detailed in Exhibit C despite its exercise of commercially reasonable and diligent efforts.

If COMPANY fails to achieve any of the Development Milestones described in Exhibit C within the timeframes specified due to causes that are beyond the reasonable control of COMPANY, (e.g., regulatory action or delay, low patient enrollment, in each case, provided that the COMPANY has conducted the relevant activities in a reasonable manner), notwithstanding COMPANY’ s reasonable, good faith efforts to achieve those milestones, then COMPANY will not be deemed in default or breach of this AGREEMENT and the timeframe for achieving those milestones will be deemed automatically extended by the time of the delay reasonably attributable to the causes that were beyond COMPANY’s control as long as COMPANY diligently and continuously pursues the achievement of such milestones. A failure on the part of COMPANY [###] to pursue timely achievement of the Development Milestones shall be deemed to be a failure within the control of COMPANY.

In the event that the foregoing paragraph does not apply, if the COMPANY fails to reach any milestone in Exhibit D for which a payment is required, then COMPANY may extend that milestone completion date and all subsequent milestone completion dates for a period of [###] (each a “Delayed Milestone”). In order to be entitled to that extension, COMPANY shall, within [###] after the applicable deadline for the achievement of the applicable milestone (i) pay to LICENSOR [###] of the Milestone Payment that would otherwise have been due had COMPANY timely achieved the applicable Milestone and (ii) [###]. If COMPANY fails to reach any Delayed Milestone, then COMPANY may obtain a further [###] month extension. In order to be entitled to the second extension, COMPANY shall, within [###] after the deadline for the achievement of the unachieved Delayed Milestone (a) pay to LICENSOR [###] of the Milestone Payment that would otherwise have been due had COMPANY timely achieved the Delayed Milestone, and (b) [###]. Total delays granted under this provision shall not exceed [###] months. Notwithstanding the above, with regard to milestone 1(g) on Exhibit C ([###]), in the event that COMPANY fails to timely achieve this milestone and seeks one or more extensions under this paragraph the payment due for any such extension shall be $[###].

Subject to the terms of this Paragraph 5.3, failure by COMPANY or its SUBLICENSEES to achieve the Development Milestones within the extended timeframe or to diligently and continuously purse the achievement of the Milestones shall be a breach of Paragraph 5.3, and may result in the [###]. In the event COMPANY ceases all activities directed at the development and commercialization of LICENSED PRODUCT(S) and LICENSED SERVICES, the rights granted to COMPANY under this AGREEMENT shall terminate immediately without further action of either PARTY.

 

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5.4 Obligations. In the event that LICENSOR determines that COMPANY, AFFILIATED COMPANIES or SUBLICENSEES, have not fulfilled their obligations under Paragraph 5.3, LICENSOR shall furnish COMPANY with written notice of such determination at which time the provisions of Paragraph 5.3 shall apply.

5.5 Patent Acknowledgement. COMPANY agrees that all packaging containing individual LICENSED PRODUCT(S) sold by COMPANY, AFFILIATED COMPANIES and SUBLICENSEE(S) will be marked with the number of the applicable patent(s) licensed hereunder in accordance with each country’s patent laws, and that patent marking requirements will otherwise be complied with.

5.6 Patent Term Extensions. COMPANY and LICENSOR agree that LICENSOR may, in its sole discretion, elect to extend the term of any patents within the PATENT RIGHTS will be extended by all means provided by law or regulation, including without limitation extensions provided under U.S. law at 35 U.S.C. §§154(b) and 156. COMPANY hereby agrees to provide LICENSOR with all necessary assistance in securing such extensions, including without limitation, providing all information regarding applications for regulatory approval, approvals granted, and the timing of same.

5.7 Challenge to Validity/Enforceability of PATENT RIGHTS by COMPANY. If COMPANY challenges the validity or enforceability of PATENT RIGHTS maintain this AGREEMENT in force during such challenge, and LICENSOR in its sole discretion determines not to terminate the AGREEMENT, then COMPANY shall reimburse LICENSOR for any and all costs incurred in defense of such proceedings, including without limitation attorney’s fees, expert witness fees and court costs, within [###] of each invoice for same submitted to COMPANY by LICENSOR or LICENSOR’s counsel. Failure to timely reimburse such costs will constitute a material breach of this AGREEMENT. In addition, any payments required hereunder must be timely made in full when due, in cash and readily available funds; and once paid, no such amounts will be subject to replevin, refund or recovery by COMPANY or AFFILIATED COMPANIES or SUBLICENSEES, irrespective of whether such challenge was successful.

ARTICLE 6

REPRESENTATIONS

6.1 Representations by LICENSOR. Except for (i) the rights of the Government of the United States of America and (ii) in connection with the transfer of biological materials for academic research purposes, LICENSOR represents and warrants that: (a) the execution, delivery and performance of this AGREEMENT have been duly authorized by all necessary corporate action on the part of LICENSOR, (b) it is the owner of the entire right, title, and interest in and to the PATENT RIGHTS, (c) it has the sole right to grant licenses thereunder, (d) it has not granted licenses thereunder or liens, encumbrances, security interests or restrictions to any other entity that would conflict with the rights granted hereunder except as stated herein, and (e)  Exhibit A contains a complete list of all current patent applications and patents owned (in whole and in part) by LICENSOR as of the EFFECTIVE DATE relating to [###]. LICENSOR covenants that it will not grant during the term of this AGREEMENT any right, license or interest in the PATENT RIGHTS,

 

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or any portion thereof, inconsistent with the license granted to COMPANY herein. LICENSOR does not warrant the validity of any patents within the PATENT RIGHTS or that practice under such patents shall be free of infringement of third party intellectual property rights, and COMPANY assumes all responsibility and liability for any such infringement. EXCEPT AS EXPRESSLY SET FORTH IN THIS PARAGRAPH 6.1, COMPANY AND AFFILIATED COMPANIES AGREE THAT THE PATENT RIGHTS ARE PROVIDED “AS IS”, AND THAT LICENSOR MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO THE PERFORMANCE OF LICENSED PRODUCT(S) OR LICENSED SERVICES INCLUDING THEIR SAFETY, EFFECTIVENESS, OR COMMERCIAL VIABILITY. LICENSOR DISCLAIMS ALL WARRANTIES WITH REGARD TO PRODUCT(S) AND SERVICES LICENSED UNDER THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ALL WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE. NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, LICENSOR ADDITIONALLY DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON THE PART OF LICENSOR AND INVENTORS, FOR DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL, AND CONSEQUENTIAL DAMAGES, ATTORNEYS’ AND EXPERTS’ FEES, AND COURT COSTS (EVEN IF LICENSORS HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE, IMPORTATION, OFFER FOR SALE OR SALE OF THE PRODUCT(S) AND SERVICES LICENSED UNDER THIS AGREEMENT. COMPANY, AFFILIATED COMPANIES AND SUBLICENSEE(S) ASSUME ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A PRODUCT OR SERVICE MANUFACTURED, USED, OR SOLD BY COMPANY, ITS SUBLICENSEE(S) AND AFFILIATED COMPANIES WHICH IS A LICENSED PRODUCT(S) OR LICENSED SERVICE AS DEFINED IN THIS AGREEMENT.

6.2 Representations by COMPANY. COMPANY represents and warrants that: (a) It is a corporation duly organized and validly existing under the laws of its jurisdiction of incorporation and has all requisite corporate power and authority to enter into this AGREEMENT, (b) it is duly authorized by all requisite action to execute, deliver and perform this AGREEMENT and to consummate the transactions contemplated hereby, and that the same do not conflict or cause a default with respect to its obligations under any other agreement and (c) it has duly executed and delivered this AGREEMENT.

ARTICLE 7

INDEMNIFICATION

7.1 Indemnification. COMPANY hereby agrees to, and shall, indemnify, defend, with counsel reasonably acceptable to LICENSOR, and hold LICENSOR, the American Lebanese Syrian Associated Charities, Inc. (ALSAC; a non-profit, 501(c)(3) corporation which supports LICENSOR), their present and former trustees, directors, governors, officers, INVENTORS of PATENT RIGHTS, agents, faculty, employees and students harmless as against any claims, demands, damages consequential, judgments, fees (including reasonable attorneys’ fees), expenses, or other costs arising from or incidental to a breach of any representation, warranty or

 

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covenant made by COMPANY in this AGREEMENT, any product liability, intellectual property infringement or other lawsuit, claim, demand or other action brought by a third party as [###], whether or not LICENSORS or said INVENTORS, either jointly or severally, are named as a party defendant in any such lawsuit and whether or not LICENSOR or the INVENTORS are alleged to be negligent or otherwise responsible for any injuries to persons or property. [###]. The obligation of COMPANY to defend, indemnify and hold harmless as set out in this Paragraph shall survive the termination of this AGREEMENT, shall continue even after grant, license or assignment of rights and responsibilities to an AFFILIATED COMPANY or SUBLICENSEE, and shall include the obligation to indemnify against any damages awarded a third party, including consequential or indirect damages. COMPANY shall require any AFFILIATED COMPANY practicing the PATENT RIGHTS and any SUBLICENSEE to agree to indemnification provisions in favor of LICENSOR substantially similar to the above.

ARTICLE 8

CONFIDENTIALITY

8.1 Confidentiality. If necessary, the Parties will exchange information they consider to be confidential, including but not limited to the terms of this AGREEMENT and any reports or information provided by COMPANY pursuant to Article 5 (“Confidential Information”). The recipient of such information agrees to accept the disclosure of said information. The recipient of Confidential Information agrees to employ all reasonable efforts to maintain the Confidential Information secret and confidential, such efforts to be no less than the degree of care employed by the recipient to preserve and safeguard its own confidential information. The Confidential Information shall not be disclosed or revealed to anyone except officers, directors, employees and contractors of the recipient who (i) have a need to know the Confidential Information, (ii) are subject to obligations of confidentiality and non-use substantially similar to those set forth in this Article 8, and (iii) have been advised by the recipient of the confidential nature of the Confidential Information and that the Confidential Information shall be treated accordingly.

The obligations of this Paragraph shall also apply to AFFILIATED COMPANIES and/or SUBLICENSEE(S) that are provided such Confidential Information by COMPANY. LICENSOR’S, COMPANY’s, AFFILIATED COMPANIES’, and SUBLICENSEES’ obligations under this Paragraph shall extend until [###] of this AGREEMENT.

8.2 Exceptions. The recipient’s obligations under Paragraph 8.1 shall not extend to any part of the Confidential Information:

 

  a. that can be demonstrated to have been in the public domain or publicly known and readily available to the trade or the public prior to the date of the disclosure; or

 

  b. that can be demonstrated, from written records to have been in the recipient PARTY’ s possession or readily available to the recipient PARTY from another source not under obligation of secrecy to the disclosing PARTY prior to the disclosure; or

 

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  c. that becomes part of the public domain or publicly known by publication or otherwise, not due to any unauthorized act by the recipient PARTY; or

 

  d. that is demonstrated from written records to have been developed by or for the receiving PARTY without reference to Confidential Information disclosed by the disclosing PARTY.

 

  e. that is required to be disclosed by law, government regulation or court order.

8.3 Right to Publish. LICENSOR may publish manuscripts, abstracts or the like describing the PATENT RIGHTS and inventions contained therein provided no Confidential Information of COMPANY as defined in Paragraph 8.1, is included or LICENSOR first obtains written approval from COMPANY to include such Confidential Information in any such public disclosure. Otherwise, LICENSOR and the INVENTORS shall be free to publish manuscripts and abstracts or the like without prior approval. The text of the proposed manuscripts, abstracts or the like containing any COMPANY Confidential Information must be provided to COMPANY at least [###] prior to the date of submission for consideration for manuscripts, abstracts or the like in order to provide COMPANY an opportunity to comment on such proposed manuscripts, abstracts or the like and determine if COMPANY Confidential Information is disclosed therein. In the event that COMPANY so comments prior to such intended submission date, LICENSOR shall delay submission of such manuscripts, abstracts or the like [###] beyond such intended submission date and, during such [###] period, engage in good faith discussion of such comments with COMPANY, and consider in good faith the modification of such proposed manuscripts, abstracts or the like pursuant to such comments, but LICENSOR will have no obligation to accept or make such modifications. Upon the request of COMPANY, LICENSOR shall remove any COMPANY Confidential Information from any proposed manuscripts, abstracts or the like.

ARTICLE 9

TERM & TERMINATION

9.1 Term. The term of this AGREEMENT shall commence on the EFFECTIVE DATE and shall continue, in each country, until the date of expiration of the last to expire VALID CLAIM included within PATENT RIGHTS in that country.

9.2 Termination by Either PARTY. This AGREEMENT may be terminated by either COMPANY or LICENSOR, in the event that the other PARTY (a) to the extent permissible under applicable and prevailing law, files or has filed against it a petition under the Bankruptcy Act, makes an assignment for the benefit of creditors, has a receiver appointed for it or a substantial part of its assets, or otherwise takes advantage of any statute or law designed for relief of debtors or (b) fails to perform or otherwise breaches any of its obligations hereunder, if, following the giving of notice by the terminating PARTY of its intent to terminate and stating the grounds therefor, the PARTY receiving such notice shall not have cured such failure or breach within sixty (60) days. In no event, however, shall such notice or intention to terminate be deemed to waive any rights to damages or any other remedy which the PARTY giving notice of breach may have as a consequence of such failure or breach.

 

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9.3 Termination by COMPANY. COMPANY may terminate this AGREEMENT and the license granted herein as to any patent application or patent within the PATENT RIGHTS, for any reason, upon giving LICENSOR [###] written notice.

9.4 Termination by LICENSOR. Except as may be otherwise expressly set forth in this AGREEMENT, in the event COMPANY breaches or defaults in the performance of its obligations under this AGREEMENT, LICENSOR may terminate this AGREEMENT and the licenses granted herein upon [###] written notice, subject to cure thereof by COMPANY in accordance with Paragraphs 5.3 and 5.4.

9.5 Obligations and Duties upon Termination. If this AGREEMENT is terminated, the PARTIES shall be released from all obligations and duties imposed or assumed hereunder to the extent so terminated, except as expressly provided to the contrary in this AGREEMENT. Upon termination subject to Paragraph 9.6, each PARTY shall cease any further use of the Confidential Information received from the other PARTY. Termination of this AGREEMENT, for whatever reason, shall not affect the obligation of any PARTY to make any payments for which it is liable prior to or upon such termination. Termination shall not affect LICENSOR’S right to recover unpaid royalties, fees, reimbursement for patent expenses, or other forms of financial compensation owed prior to termination. Upon termination, COMPANY shall submit a final royalty report to LICENSOR and any royalty payments (if after first commercial sale of LICENSED PRODUCTS), fees, unreimbursed patent expenses and other financial compensation due to LICENSOR shall become immediately payable. Furthermore, upon termination of this AGREEMENT, all rights in and to the PATENT RIGHTS shall revert immediately to LICENSOR at no cost to LICENSOR. Upon any termination of this AGREEMENT, any SUBLICENSEE(S) shall become, with such SUBLICENSEE(S)’ agreement, a direct licensee of LICENSOR, provided that (a) such SUBLICENSEE(S) cure any default of the COMPANY of which they are legally capable, including in all events paying all amounts due under this AGREEMENT, (b) such SUBLICENSEE(S) was not the cause of terminations, and (c) LICENSOR’S obligations to SUBLICENSEE(S) are no greater than LICENSOR’S obligations to COMPANY under this AGREEMENT and the SUBLICENSEE’S obligations to LICENSOR are no greater than the obligations of COMPANY to LICENSOR under this AGREEMENT. COMPANY shall provide written notice of such to each SUBLICENSEE(S) with a copy of such notice provided to LICENSOR.

9.6 COMPANY may, within [###] of the effective date of any termination of this AGREEMENT, sell all LICENSED PRODUCTS and parts therefor that it has on hand at the date of termination, if COMPANY pays to LICENSOR the earned royalty thereon.

ARTICLE 10

MISCELLANEOUS

10.1 Use of Name or Logo. Neither LICENSOR nor COMPANY shall use the name, image or logo of the other PARTY, or the name of an affiliate, a current of former staff member, employee, student or affiliated physician or faculty of the other PARTY, or any adaptation thereof, in any advertising, promotional or sales literature without the prior written approval of the PARTY.

 

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10.2 Notification of Promotion and Acknowledgment of Contributions. COMPANY shall notify the LICENSOR in writing at least [###] in advance of any press release or promotional communication related to LICENSED PRODUCTS or LICENSED SERVICES or from any innovations that are a downstream result of research involving the LICENSED PRODUCTS or LICENSED SERVICES to determine whether the LICENSOR wishes to be acknowledged. Promotional communications include online content, brochures, advertising or public presentations. For any such release or promotion, COMPANY shall include, at the LICENSOR’S discretion, [###].

10.3 No Partnership. Nothing in this AGREEMENT shall be construed to create any agency, employment, partnership, joint venture or similar relationship between LICENSOR and COMPANY other than that of a licensor/licensee. Neither LICENSOR nor COMPANY shall have any right or authority whatsoever to incur any liability or obligation (express or implied) or otherwise act in any manner in the name or on the behalf of the other, or to make any promise, warranty or representation binding on the other.

10.4 Notice of Claim. Each, LICENSOR and COMPANY, shall give the other or its representative immediate notice of any suit or action filed, or prompt notice of any claim made, against them arising out of the performance of this AGREEMENT or arising out of the practice of the inventions licensed hereunder.

10.5 Insurance. Prior to initial human testing or FIRST COMMERCIAL SALE of any LICENSED PRODUCT(S) or LICENSED SERVICES as the case may be and thereafter until [###], COMPANY and SUBLICENSEES shall establish and maintain insurance coverage in such country in the minimum amount of [###], to cover any liability arising from COMPANY’S indemnification obligations under Article 7 above with respect to such human testing or commercial sale of LICENSED PRODUCT(S) or LICENSED SERVICE, and prior to the expiration of such period shall obtain tail coverage for the same limits. Prior to initial human testing or FIRST COMMERCIAL SALE of any LICENSED PRODUCT(S) as the case may be and thereafter until [###], COMPANY and SUBLICENSEES shall establish and maintain, in each country in which COMPANY, an AFFILIATED COMPANY or SUBLICENSEE(S) shall test or sell LICENSED PRODUCT(S), product liability or other appropriate insurance coverage in the minimum amount of [###], and prior to the expiration of such period shall obtain tail coverage for the same limits. COMPANY will annually present evidence, in the form of a statement in the annual report to LICENSOR that such coverage is being maintained. Upon LICENSOR’S request, COMPANY will furnish LICENSOR with a Certificate of Insurance of each insurance policy obtained. LICENSOR and ALSAC shall be listed as additional insureds in COMPANY’s, AFFILIATED COMPANIES’ and SUBLICENSEES’ said insurance policies. If such insurance is underwritten on a ‘claims made’ basis, COMPANY agrees that any change in underwriters during the term of this AGREEMENT and thereafter so long as LICENSED PRODUCTS are being sold will require the purchase of ‘prior acts’ coverage to ensure that coverage will be continuous throughout the Term of this AGREEMENT and thereafter until [###] following expiration dating of the last batch of LICENSED PRODUCT manufactured. All such insurance shall be primary and non-contributory. All such insurers shall have a minimum financial rating by A.M Best of [###].

 

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10.6 Governing Law and Venue. Any legal action arising from this AGREEMENT shall be brought in Memphis, Tennessee and shall be governed by the law of the State of Tennessee, without regard to the conflicts of laws provisions thereof.

10.7 Notice. All notices or communication required or permitted to be given by either PARTY hereunder shall be deemed sufficiently given if mailed by registered mail or certified mail, return receipt requested, or sent by overnight courier, such as Federal Express, to the other PARTY at its respective address set forth below or to such other address as one PARTY shall give notice of to the others from time to time hereunder or if sent by facsimile to the other PARTY at its respective facsimile number provided below and receipt is acknowledged. Mailed notices shall be deemed to be received on the third business day following the date of mailing. Notices sent by overnight courier shall be deemed received the following business day.

 

If to COMPANY:    Chief Executive Officer
   Juno Therapeutics, Inc.
   8725 W. Higgins Road, Suite 290
   Chicago, IL 60631
If to ST. JUDE:    Director, Office of Technology Licensing
   St. Jude Children’s Research Hospital
   262 Danny Thomas Place, Mail Stop 742
   Memphis, Tennessee
   Phone: (901) 595-2342
   Fax: (901) 595-3148

10.8 Compliance with All Laws. In all activities undertaken pursuant to this AGREEMENT, LICENSOR and COMPANY covenant and agree that each will in all material respects comply with such Federal, state and local laws and statutes, as may be in effect at the time of performance and all valid rules, regulations and orders thereof regulating such activities.

10.9 Successors and Assigns. Neither this AGREEMENT nor any of the rights or obligations created herein, except for the right to receive any remuneration hereunder, may be assigned by either PARTY, in whole or in part, without the prior written consent of the other PARTY, except that either PARTY shall be free to assign this AGREEMENT without the consent of the other party (i) to any AFFILIATED COMPANY at least having an ability comparable to COMPANY in performing under this AGREEMENT, or (ii) in the case of the COMPANY, in connection with any sale of substantially all of its assets of COMPANY relating to this AGREEMENT, but in each case, shall provide written notice of such assignment and assumption along with an executed copy thereof or of the written notice of a change of control, as the case may be, within thirty (30) days of its occurrence. This AGREEMENT shall bind and inure to the benefit of the successors and permitted assigns of the PARTIES hereto.

 

[ ### ] = REDACTED INFORMATION


10.10 No Waivers; Severability. No waiver of any breach of this AGREEMENT shall constitute a waiver of any other breach of the same or other provision of this AGREEMENT, and no waiver shall be effective unless made in writing. Any provision hereof prohibited by or unenforceable under any applicable law of any jurisdiction shall as to such jurisdiction be deemed ineffective and deleted herefrom without affecting any other provision of this AGREEMENT. It is the desire of the PARTIES hereto that this AGREEMENT be enforced to the maximum extent permitted by law, and should any provision contained herein be held by any governmental agency or court of competent jurisdiction to be void, illegal and unenforceable, the PARTIES shall negotiate in good faith for a substitute term or provision which carries out the original intent of the PARTIES.

10.11 Entire Agreement; Amendment. COMPANY and LICENSOR acknowledge that they have read this entire AGREEMENT and that this AGREEMENT, including the attached Exhibits constitutes the entire understanding and contract between the PARTIES hereto and supersedes any and all prior or contemporaneous oral or written communications with respect to the subject matter hereof. It is expressly understood and agreed that (i) there being no expectations to the contrary between the PARTIES hereto, no usage of trade, verbal agreement or another regular practice or method dealing within any industry or between the PARTIES hereto shall be used to modify, interpret, supplement or alter in any manner the express terms of this AGREEMENT; and (ii) this AGREEMENT shall not be modified, amended or in any way altered except by an instrument in writing signed by both of the PARTIES hereto.

10.12 Delays or Omissions. Except as expressly provided herein, no delay or omission to exercise any right, power or remedy accruing to any PARTY hereto, shall impair any such right, power or remedy to such PARTY nor shall it be construed to be a waiver of any such breach or default, or an acquiescence therein, or waiver or acquiescence in any similar breach or default, or be deemed a waiver or acquiescence of any other breach or default theretofore or thereafter occurring. Any waiver, permit, consent or approval of any kind or character on the part of any PARTY of any breach or default under this AGREEMENT, or any waiver on the part of any PARTY of any provisions or conditions of this AGREEMENT, must be in writing and shall be effective only to the extent specifically set forth in such writing. All remedies either under this AGREEMENT or by law or otherwise afforded to any PARTY, shall be cumulative and not alternative.

10.13 Force Majeure. If a PARTY fails to fulfill its obligations hereunder (other than an obligation for the payment of money), when such failure is due to an act of God, or other circumstances beyond its reasonable control, including but not limited to fire, flood, civil commotion, riot, war (declared and undeclared), revolution, epidemics, terrorism, earthquake or embargoes, then said failure shall be excused for the duration of such event and for such a time thereafter as is reasonable to enable the parties to resume performance under this AGREEMENT, provided however, that in no event shall such time extend for a period of more than one hundred eighty (180) days.

10.14 Further Assurances. Each PARTY shall, at any time, and from time to time, prior to or after the EFFECTIVE DATE of this AGREEMENT, at reasonable request of the other PARTY, execute and deliver to the other such instruments and documents and shall take such actions as may be required to more effectively carry out the terms of this AGREEMENT.

 

[ ### ] = REDACTED INFORMATION


10.15 Survival. The provisions of Paragraphs 3.2 – 3.8 (with respect to fees and other amounts accruing prior to termination, and in connection with sales after termination pursuant to Paragraphs 9.5 and 9.6, shall survive expiration or termination of the AGREEMENT. All representations, warranties, covenants and agreements made herein and which by their express terms or by implication are to be performed after the expiration and/or termination hereof, or are prospective in nature, shall survive such expiration and/or termination, as the case may be. This shall include Paragraphs 5.1 (Reports), 5.2 (Records), and Articles 7, 8, and 10.

10.16 No Third Party Beneficiaries. Nothing in this AGREEMENT shall be construed as giving any person, firm, corporation or other entity, other than the PARTIES hereto and their successors and permitted assigns, any right, remedy or claim under or in respect of this AGREEMENT or any provision hereof.

10.17 Headings. Article headings are for convenient reference and not a part of this AGREEMENT. All Exhibits are incorporated herein by this reference.

10.18 Counterparts. This AGREEMENT may be executed in counterparts, each of which shall be deemed an original and all of which when taken together shall be deemed but one instrument.

 

[ ### ] = REDACTED INFORMATION


IN WITNESS WHEREOF, this AGREEMENT shall take effect as of the EFFECTIVE DATE when it has been executed below by the duly authorized representatives of the parties.

 

JUNO THERAPEUTICS, INC.      ST. JUDE CHILDREN’S RESEARCH HOSPITAL, INC.

/s/ Hans Bishop

    

/s/ William E. Evans

Name: Hans Bishop      Name: William E. Evans
Title: CEO      Title: Director and CEO

Dec 3 rd , 2013

    

Dec 3, 2013

(Date)      (Date)

EXHIBIT A. PATENT RIGHTS LIST

EXHIBIT B. LICENSE FEE & ROYALITIES

EXHIBIT C. DEVELOPMENTAL MILESTONES & MILESTONE PAYMENTS

EXHIBIT D: SALES & ROYALTY REPORT FORM

EXHIBIT E: MATERIAL TRANSFER AGREEMENT – BASIC RESEARCH

EXHIBIT F; MATERIAL TRANSFER AGREEMENT – CLINICAL RESEARCH

 

[ ### ] = REDACTED INFORMATION


EXHIBIT A

PATENT RIGHTS LIST

U.S. Patent No. 8,399,645, titled “Chimeric Receptors with 4-1BB Stimulatory Signaling Domain”

[###]

 

 

[ ### ] = REDACTED INFORMATION


EXHIBIT B

LICENSE FEE & ROYALTIES

1. License Fee: The license fee due under Paragraph 3.1 within [###] of the EFFECTIVE DATE is twenty-five million U.S. dollars ($25,000,000).

2. Minimum Annual Royalties: The minimum annual royalties pursuant to Paragraph 3.2 are:

 

  1 st year—January 1, 2015:    One hundred thousand U.S. dollars ($100,000)
  2 nd year—January 1, 2016:    One hundred thousand U.S. dollars ($100,000)
  January 1 of every year thereafter during the term of the Agreement:    Five hundred thousand U.S. dollars ($500,000)

3. Royalties: The running royalty rate payable under Paragraph 3.3 is [###] percent ([###]%) of NET SALES. [###]. If a LICENSED PRODUCT OR LICENSED SERVICE is covered by more than one patent or patent application within the PATENT RIGHTS, [###].

4. SUBLICENSE CONSIDERATION: The SUBLICENSE CONSIDERATION payable under Paragraph 3.4 is as follows:

LICENSOR shall receive [###] of SUBLICENSE CONSIDERATION.

 

[ ### ] = REDACTED INFORMATION


EXHIBIT C

[###]

 

[ ### ] = REDACTED INFORMATION


EXHIBIT D

[###]

 

 

[ ### ] = REDACTED INFORMATION


EXHIBIT E

[###]

 

[ ### ] = REDACTED INFORMATION


EXHIBIT F

[###]


EXHIBIT 3.02(b)

Basis for Other Royalties

Section 9.3(h)(i) of the Penn-Novartis Collaboration sets out certain royalties that are to be paid by Novartis to Penn, as specified in a table set forth in that section (the “ Table ”). The following two tables, collectively, in this Exhibit 3.02 restate the Table after giving effect to certain changes agreed by Novartis and Penn in connection with the overall transactions contemplated by this Agreement and reflect such royalty payment obligations between Novartis and Penn as of the Effective Date (which shall form the basis for the calculation contemplated under Section 3.02(b)). The calculation of such royalties take into consideration the definition of “Initial CD19 Product” provided for in the Penn-Novartis Collaboration since the royalties that may become due to Penn under the Penn-Novartis Collaboration depend on (A) if the Initial CD19 Product is a CART19 Product or a humanized CART19 Product and (B) if the Initial CD19 Product is not a CART19 Product or a humanized CART19 Product:

A. If the Initial CD19 Product is a CART19 Product or a humanized CART19 Product, then:

 

Worldwide Annual Net Sales of a Product (on a Product-by-Product basis)
during the applicable Calendar Year during the Royalty Term:

   I. Royalty Rate
Applicable to any Initial
CD19 Product:
  II. Royalty Rate
Applicable to any
Product other
than an Initial
CD19 Product:

Portion less than or equal to $[***]:

   [***]%   [***]%

Portion greater than $[***], but less than or equal to $[***]:

   [***]%   [***]%

Portion greater than $[***]:

   [***]%   [***]%

B. If the Initial CD19 Product is not a CART19 Product or a humanized CART19 Product, then:

 

 

Worldwide Annual Net Sales of a Product (on a Product-by-Product
basis) during the applicable Calendar Year during the Royalty Term:

   I. Royalty Rate
Applicable to any
Initial CD19
Product:
  IIA. Royalty Rate
Applicable to
CART19 Product
and any
humanized
CART19 Product:
  IIB. Royalty Rate
Applicable to any
Product other than
an Initial CD19
Product or any
CART19 Product
and any humanized
CART19 Product:

Portion less than or equal to $[***]:

   [***]%   [***]%   [***]%

Portion greater than $[***], but less than or equal to $[***]:

   [***]%   [***]%   [***]%

Portion greater than $[***]:

   [***]%   [***]%   [***]%

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


EXHIBIT 3.06(a)(i)

LETTER TO THE EDITOR

NEW ENGLAND JOURNAL OF MEDICINE

“Dear [insert name of editor]:

We write to request that the New England Journal of Medicine publish the following addendum in connection with the articles referenced below:

[***]

Thank you for your prompt consideration of this request.”

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


EXHIBIT 3.06(a)(ii)

LETTER TO THE EDITOR

SCIENCE TRANSLATIONAL MEDICINE

“Dear [insert name of editor]:

We write to request that Science Translational Medicine publish the following addendum in connection with the article referenced below:

[***]

Thank you for your prompt consideration of this request.”

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


EXHIBIT 4.01

FORM OF ROYALTY REPORT

QUARTERLY SALES & ROYALTY REPORT

[***]

[***]

 

[***]

  

[***]

  

[***]

  

[***]

  

[***]

  

[***]

  

[***]

 

 

[***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


EXHIBIT 5.02

FORM OF DISMISSAL

(see attachment)

 


IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

 

TRUSTEES OF THE UNIVERSITY OF

PENNSYLVANIA and NOVARTIS

PHARMACEUTICALS CORPORATION,

 

Plaintiffs and

Counter-Defendants,

 

v.

 

ST. JUDE CHILDREN’S RESEARCH

HOSPITAL, INC. and

JUNO THERAPEUTICS, INC.,

 

Defendants and

Counterclaimants.

 

  

 

Civil Action No. 2:13-CV-01502-SD

ST. JUDE CHILDREN’S RESEARCH

HOSPITAL, INC. and JUNO

THERAPEUTICS, INC.,

 

Counterclaimants ,

 

v.

 

NOVARTIS PHARMACEUTICALS

CORPORATION and NOVARTIS

INSTITUTES FOR BIOMEDICAL

RESEARCH, INC.,

 

Counter-Defendants .

  

STIPULATION OF DISMISSAL PURSUANT TO FED. R. CIV. P. 41(a)(1)(ii)

Whereas Plaintiff Trustees of the University of Pennsylvania (“the University”), Plaintiff and counterclaim-defendant Novartis Pharmaceuticals Corporation, Counterclaim-defendant Novartis Institutes for Biomedical Research, Inc. (together with Novartis Pharmaceuticals Corporation, “Novartis”), Defendant and


Counterclaimant St. Jude Children’s Research Hospital, Inc. (“St. Jude”), and Defendant and Counterclaimant Juno Therapeutics, Inc. (“Juno”) (the University, Novartis, St. Jude and Juno, collectively, the “Parties”) have entered into agreements resolving the above-captioned litigation, the Parties, through their undersigned counsel, hereby stipulate and agree as follows:

 

1. Subject to paragraph 2 below, the above-captioned litigation, including all claims, counterclaims and affirmative defenses, is dismissed with prejudice. Subject to any contractual relationships that exist between or among any of the Parties, each of the Parties is to bear its own costs and attorney’s fees.;

 

2. The rights of the University and Novartis to assert non-infringement, invalidity and unenforceability of U.S. Patent No. 8,399,645 by way of counterclaim or defense in the event that the patent is, in the future, asserted against them, are preserved.


Dated: April     , 2015   
Madeline M. Sherry (PA Bar I.D. No. 31549)    Abraham C. Reich (PA Bar I.D. No. 20060)
GIBBONS, P.C.    Robert S. Tintner (PA Bar I.D. No. 73865)
1700 Two Logan Square    FOX ROTHSCHILD LLP
18th & Arch Streets    2000 Market Street, 20 th Floor
Philadelphia, PA 19103-2769    Philadelphia, PA 19103-3222
Phone: 215-446-6201    Phone: 215-299-2000
Fax: 215-446-6311    Fax: 215-299-2150
David K. Barr ( pro hac vice )    Morgan Chu ( pro hac vice )
Aaron Stiefel ( pro hac vice )    Andrei Iancu ( pro hac vice )
Richard A. De Sevo ( pro hac vice )    Alan J. Heinrich ( pro hac vice )
Abigail Langsam ( pro hac vice)    IRELL & MANELLA LLP
KAYE SCHOLER LLP    1800 Avenue of the Stars, Suite 900
250 W. 55th Street    Los Angeles, CA 90067-4276
New York, NY 10019-9710    Phone: 310-277-1010
Phone: 212-836-8000    Fax: 310-203-7199
Fax: 212-836-8639   
   Attorneys for Juno Therapeutics, Inc.

Attorneys for Novartis Pharmaceuticals Corporation

and Novartis Institutes for BioMedical Research, Inc.

  
   Daniel Segal (PA Bar I.D. No. 26218)
Eric Kraeutler (PA Bar I.D. No. 32189)    HANGLEY ARONCHICK SEGAL PUDLIN &
John V. Gorman (PA Bar I.D. No. 80631)    SCHILLER
Deborah W. Frey (PA Bar I.D. No. 310717)    One Logan Square, 27 th Floor
Aaron V. Skrypski (PA Bar I.D. No. 209336)    Philadelphia, PA 19103
MORGAN, LEWIS & BOCKIUS LLP    Phone: 215-496-7300
1701 Market Street   
Philadelphia, PA 19103-2921    Glenn L. Krinsky ( pro hac vice )
Phone: 215-963-5000    JONES DAY
Fax: 215-963-5001    555 South Flower Street, 50 th Floor
   Los Angeles, CA 90071
Attorneys for Trustees of the University of    Phone: 213-489-3939
Pennsylvania   
   Alan E. Friedman ( pro hac vice )
   FOLEY & LARDNER LLP
   555 South Flower Street, Suite 3500
   Los Angeles, CA 90028
   213-972-4500
   Attorneys for St. Jude Children’s Research Hospital,
   Inc.


EXHIBIT 8.03(d)

RECIPIENTS OF THE PENN CONSTRUCT

 

Institution

  

Contact(s)

  

Address

  

Date(s) of Transfer

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

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


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

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


EXHIBIT 8.03(e)

THIRD PARTIES

Novartis Institutes for BioMedical Research, Inc.

250 Massachusetts Avenue

Cambridge, MA 02139


EXHIBIT 13.10(a)

NOVARTIS STANDBY STATEMENT

Novartis and its co-party, the Trustees of the University of Pennsylvania, have settled their litigation with St. Jude Children’s Research Hospital, Inc. and Juno Therapeutics, Inc. involving patent and contract claims relating to our chimeric antigen receptor (CAR) CTL019 research and development program. Under the litigation settlement, all of the parties claims are dismissed, and Novartis is licensed to continue research, development and commercialization of CTL019 and subsequent CART-19 therapy programs that may be within the scope of the patent that was the subject of the litigation.

Our collaboration with Penn was formed to bring important new therapies to patients who are in desperate need of new treatment options. We are proud to be working with Carl June and the renowned researchers from Penn.

The clinical trials to date have indicated that CTL019 has the potential to treatrelapsed/refractory acute lymphoblastic leukemia and shows potential in other B-cell malignancies for patients who have exhausted all other treatment options.

Questions & answers

Q1Why did you settle with Juno?

A1With the litigation behind us, we can focus on bringing this important therapy to patients. Novartis is licensed to continue research, development and commercialization of CTL019 and subsequent CART-19 therapy programs that may be within the scope of the patent that was the subject of the litigation.

Q2 What are the terms of the settlement?

A2Novartis will receive a non-exclusive license from Juno to the licensed patents. In exchange, Novartis will provide to Juno:

 

  Initial payment of $12.25 million

 

  Future milestone payments

 

  low to mid single digit royalties—dependent upon geography

Q3Does this outcome impact the progress/development of CTL019 or other CAR research programs conducted by Novartis and Penn?

A3No. Novartis is licensed to continue research, development and commercialization of CTL019 and subsequent CART-19 therapy programs that may be within the scope of the patent that was the subject of the litigation.

Q4How is CTL019 different from the Juno therapy?

A4Each CAR therapy is unique and the therapies being developed cannot be broadly defined as a single “class.” Although there are some similarities, these are complex programs that use different approaches and are derived from a patient’s own T cells. [Note, Juno has three “founding partners” (MSKCC, Fred Hutchinson Cancer Center,and Seattle Children’s Hospital) each of which have different CART-19 products under development]


EXHIBIT 13.10(b)

JUNO PRESS RELEASE


JUNO THERAPEUTICS ANNOUNCES PATENT LITIGATION SETTLEMENT

SEATTLE (April     , 2015) – Juno Therapeutics, Inc. (NASDAQ: JUNO) today announced that it entered into a settlement agreement to resolve litigation with the Trustees of the University of Pennsylvania (“Penn”) and Novartis Pharmaceuticals Corporation (“Novartis”). Juno became a party to the litigation after it entered into a December 2013 license agreement with St. Jude Children’s Research Hospital (“St. Jude”), also a party in the litigation, for patent rights owned by St. Jude. The litigation itself, which began in July 2012 in connection with a contract dispute between St. Jude and Penn, was broadened in March 2013 to include a dispute concerning St. Jude’s U.S. Patent No. 8,399,645, titled “Chimeric Receptors with 4-1BB Stimulatory Signaling Domain.”

Under the terms of the settlement, Novartis agreed to make payments to Juno including an initial payment of $12.25 million, future milestone payments, and mid-single digit royalties from U.S. net sales of product candidates related to the disputed contract and patent claims, as well as a low double digit percentage of the royalties Novartis pays to Penn for global net sales for those product candidates. Payments received by Juno will be shared with St. Jude under the terms of the license agreement between Juno and St. Jude. The parties also agreed to dismiss all claims in the relevant legal proceedings.

“We are pleased by this settlement, which benefits patients by allowing each party to advance its promising cancer immunotherapies and rewards the investigators on whose insights those developments are based,” said Juno CEO, Hans Bishop.

About Juno

Juno Therapeutics, Inc. (“Juno”) is building a fully integrated biopharmaceutical company focused on revolutionizing medicine by re-engaging the body’s immune system to treat cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Multiple product candidates have shown compelling evidence of tumor shrinkage in the clinical trials in refractory leukemia and lymphoma conducted to date. The company’s long-term aim is to improve and leverage its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world’s leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children’s Research Institute, and The National Cancer Institute.

www.JunoTherapeutics.com


Forward Looking Statements

This press release contains forward-looking statements, including statements regarding the dismissal of certain litigation, future payments related to the settlement of that litigation, and the benefits of that settlement. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: payments related to the settlement, the success, cost and timing of product development activities and clinical trials; the ability to obtain regulatory approval for and to commercialize product candidates; and regulatory requirements and regulatory developments; and Juno’s ability to obtain, maintain, or protect intellectual property rights related to its product candidates; amongst others. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Juno’s business in general, see Juno’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 19, 2015. These forward-looking statements speak only as of the date hereof, and Juno disclaims any obligation to update these forward-looking statements.

Investor Relations Contact:

David Walsey, W2O Group

dwalsey@w2ogroup.com , 858-617-0772

Media Contact:

Andreas Marathovouniotis, W2O Group

amarathis@w2ogroup.com , 212-301-7174

# # #


ANNEX A

AMENDMENT #1 TO LICENSE AGREEMENT


FIRST AMENDMENT TO LICENSE AGREEMENT

This first amendment (“Amendment’’) to the License Agreement dated December 3, 2013 (“License”) between St. Jude Children’s Research Hospital, Inc. (“St. Jude”) and Juno Therapeutics, Inc. (“Licensee”) is made effective as of February 20, 2014.

WHEREAS, the parties wish to amend Article 4.3.b. to reflect the accurate amount of past litigation costs incurred by St. Jude;

NOW THEREFORE, based upon the above premises, the parties agree to amend the License Agreement as follows:

Replace the following existing sentence in Article 4.3.b:

“Any recovery in such action (from damages, awards or settlements) shall be allocated as follows: first, LICENSOR shall receive past litigation costs of approximately four million five hundred thousand U.S. dollars ($4.5 million) to reimburse it for LICENSOR’s documented costs and expenses incurred in connection with the foregoing litigation prior to the EFFECTIVE DATE (exact costs to be included in an amendment to this AGREEMENT within 3 months of the EFFECTIVE DATE), second each party shall be reimbursed for its costs and expenses incurred by it in connection with such actions after the EFFECTIVE DATE, and then any remainder shall be shared [***] to COMPANY and [***] to LICENSOR.”

with the following new sentence:

“Any recovery in such action (from damages, awards or settlements) shall be allocated as follows: first, LICENSOR shall receive past litigation costs of four million four hundred seventy five thousand, five hundred ninety two U.S. dollars ($4,475,592) to reimburse it for LICENSOR’s documented costs and expenses incurred in connection with the foregoing litigation prior to the EFFECTIVE DATE, second each party shall be reimbursed for its costs and expenses incurred by it in connection with such actions after the EFFECTIVE DATE, and then any remainder shall be shared [***] to COMPANY and [***] to LICENSOR.”

This amendment comes into force upon signature by the duly authorized representatives of both parties to the License. All other terms and conditions remain unchanged.

 

ST JUDE:      LICENSEE:
ST. JUDE CHILDREN’S RESEARCH HOSPITAL INC.      JUNO THERAPEUTICS, INC.

By:

 

/s/ William E. Evans

William E. Evans, PhD

Director and CEO

    

By:

  

/s/ Hans Bishop

Hans Bishop

CEO

Date:   2-21-14      Date:    2/24/14

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Exhibit 10.2

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Execution Copy

NON-EXCLUSIVE SUBLICENSE AGREEMENT

This Non-Exclusive Sublicense Agreement (“ Agreement ”) is entered into as of the Effective Date by and between Juno Therapeutics, Inc., a Delaware corporation having its principal place of business at 307 Westlake Avenue North, Suite 300, Seattle, Washington 98109, United States of America (“ Juno ”), Novartis Institutes for Biomedical Research, Inc., a Delaware corporation having offices located at 250 Massachusetts Avenue, Cambridge, Massachusetts 02139, United States of America (“ Novartis ”), and The Trustees of the University of Pennsylvania, a nonprofit corporation organized under the laws of Commonwealth of Pennsylvania, United States of America (“ Penn ” and, together with Novartis and Juno, the “ Parties ”).

RECITALS

 

  A. WHEREAS, Juno and St. Jude Children’s Research Hospital, Inc., a nonprofit corporation organized under the laws of State of Tennessee, (“ St. Jude ”) have entered into an exclusive license to certain patent applications and patents (the “ Licensed Patents ”), Including U.S. Patent No. 8,399,645 (the “’ 645 Patent ”), owned by St. Jude for use in humans;

 

  B. WHEREAS, Juno, St. Jude, Novartis and Penn are parties to The Trustees of the University of Pennsylvania v. St. Jude Children’s Research Hospital, Inc. , Civil Action No. 2:13-cv-01502-SD; Trustees of the University of Pennsylvania v. St. Jude’s Children’s Research Hospital , Civil Action No. 2:12-cv-04122-SD; and St. Jude Children’s Research Hospital v. Trustees of the University of Pennsylvania , Civil Action No. 2:12-cv-05878-SD, pending before the United States District Court, Eastern District of Pennsylvania (collectively, the “ Litigation ”); and

 

  C. WHEREAS, Novartis wishes to obtain a non-exclusive license from Juno to the Licensed Patents for use in the Field (as defined below), on the terms and conditions set forth herein.

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

ARTICLE I

DEFINITIONS

The following words and phrases shall have meanings set forth below solely for purposes of this Agreement:

1.01 “ Affiliate ” shall mean any corporation, company, limited liability company or other entity, which controls, is controlled by or is under common control with the Party in question. For purposes of this definition, control shall mean the direct or indirect ownership of

 

1


Execution Copy

 

more than fifty percent (50%) of the stock having the right to vote for directors thereof or the ability to otherwise control the management of the corporation, association or other business entity whether through the ownership of voting securities, by contract, resolution, regulation or otherwise.

1.02 “ Assertion Entity ” shall mean each of Penn, Novartis, their respective Affiliates, any sublicensee of Novartis or its Affiliates under this Agreement (permitted in accordance with Section 2.02) and/or any entity that Penn or Novartis, their respective Affiliates, or such sublicensees of Novartis or its Affiliates under this Agreement has authorized to commence or conduct any legal proceeding against Juno, any sublicensee of Juno or St. Jude, or assists in the conduct of any such legal proceeding.

1.03 “ BLA ” shall mean a Biologics License Application, as defined in the U.S. Federal Food, Drug, and Cosmetics Act, as amended, and the regulations promulgated thereunder, any alternate market approval application Including a New Drug Application or 510k application, and any corresponding supranational, foreign or domestic equivalent marketing authorization application, registration or certification, necessary to market a Licensed Product.

1.04 “ Business Day ” shall mean a day on which banking institutions in both Seattle, Washington and Basel, Switzerland are open for business, but in any event excluding the nine (9) consecutive calendar days beginning on December 24th and continuing through January 1st of each calendar year and all Saturdays and Sundays.

1.05 “ Calendar Quarter ” shall mean each three month period commencing January 1, April 1, July 1 and October 1 of each calendar year.

1.06 “ CART-19 ” shall mean a chimeric antigen receptor T cell directed against CD19.

1.07 “ CART-19 Supplier ” shall mean any supplier, contractor or manufacturing organization with respect to any component, product candidate, product and/or service provided by such party, directly or indirectly, in connection with any CART-19 product or CART-19 service (Including the use, manufacture or provision thereof), solely when and to the extent that such party is acting in such capacity related to such CART-19 product or CART-19 service.

1.08 “ Effective Date ” shall mean the date on which the parties file the form of dismissal attached hereto as Exhibit 5.02, pursuant to Article V of this Agreement and subject to the conditions set forth therein.

1.09 “ FDA ” shall mean the United States Food and Drug Administration, or any successor agency thereto.

1.10 “ Field ” shall mean all therapeutic, diagnostic, preventative and palliative uses.

 

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1.11 “ First Assert ” shall mean any legal proceeding commenced or otherwise prosecuted by any Assertion Entity, Including any legal proceeding conducted by any entity that is acquired by or merged with any Assertion Entity (“ Control Transaction ”) that, prior to such Control Transaction, initiated legal proceedings against Juno or St. Jude that are not terminated within [***] days of the close of such Control Transaction, whether such legal proceeding is before a court of law, an administrative body (Including the U.S. Patent and Trademark Office or the International Trade Commission) or any other tribunal entity, where relief is sought to invalidate a Licensed Patent before St. Jude, Juno or their respective Affiliates has commenced or otherwise prosecuted any similar proceedings against Penn, Novartis or their respective Affiliates.

1.12 “ First Commercial Sale ” shall mean (a) the first sale in the Territory of Licensed Product by Novartis, its Affiliates or Permitted Sublicensees to a Third Party after such Licensed Product has been granted regulatory approval, Including pricing approval, by the appropriate regulatory authority(ies) for the relevant country or region or (b) the first performance of a Licensed Service in exchange for consideration. First Commercial Sale excludes any sale or other distribution of Licensed Product for use in a clinical trial or other development activity, for promotional use, Including samples, or for use in a compassionate use or similar program.

1.13 “Including” shall mean “including but not limited to” and “including without limitation.”

1.14 “ Licensed Patents ” shall mean (a) the patent and patent applications listed on Exhibit 1.14 hereto; (b) any other patent or patent application that is a divisional, continuation, reissue, renewal, reexamination, substitution or extension of any patent or patent application identified in (a); (c) any patents subsequently issuing on any patent application identified in (a) or (b), Including any reissues, renewals, reexaminations, substitutions or extensions thereof; and (d) those claims of a continuation-in-part application or patent (Including any reissues, renewals, reexaminations, substitutions or extensions thereof) that are entitled to the priority date of at least one of the patents or patent applications identified in (a), (b) or (c). Specifically excluded from Licensed Patents are U.S. Patent Nos. [***] and [***], and any other patent or patent application that claims priority to, or common priority with, or is a divisional, continuation, re-issue, renewal, reexamination, substitution or extension of any patent or patent application identified in clause (a) above that contains only claims directed to the [***].

1.15 “ Licensed Product ” shall mean any material, cell, composition or drug, the manufacture, use, importation, offer for sale or sale of which would infringe any Valid Claim but for the license granted under this Agreement. For the avoidance of doubt, as of the Effective Date ( i.e., as the Licensed Patents and Valid Claims thereunder exist as of the Effective Date), the [***] are Licensed Products, as defined under this Agreement.

1.16 “ Licensed Services ” shall mean any service using a Licensed Product, the performance of which would infringe a Valid Claim but for the license granted under this Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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1.17 “ Net Sales ” shall mean the net sales in the Territory recorded by Novartis or any of its Affiliates or Permitted Sublicensees for sale of any Licensed Product to, and performance of any Licensed Service for, a Third Party other than a Permitted Sublicensee, distributor and wholesaler, as [***]. The deductions booked on an accrual basis by Novartis, its Affiliates and its Permitted Sublicensees under Novartis Accounting Standards, to calculate the recorded net sales from gross sales include the following, in each case, to the extent actually accrued, discounted or credited, as applicable, and without duplication:

 

  (i) customary trade and cash discounts;

 

  (ii) amounts repaid or credited by reasons of defects, rejections or recalls or returns;

 

  (iii) [***];

 

  (iv) [***];

 

  (v) [***];

 

  (vi) [***];

 

  (vii) [***]; and

 

  (viii) other reductions for specifically identifiable amounts deducted for reasons substantially similar to those listed in clauses (i) through (vii) above if [***].

With respect to the calculation of Net Sales:

 

  (A) [***]; and

 

  (B) If a Licensed Product is delivered to the Third Party before being invoiced (or is not invoiced), Net Sales will be calculated [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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1.18 “ Novartis Accounting Standards ” shall mean the IFRS (International Financial Reporting Standards), as generally and consistently applied throughout the Novartis’s organization. Novartis shall promptly notify Juno in the event that it changes the Novartis Accounting Standards pursuant to which its records are maintained, it being understood that Novartis may only use internationally recognized accounting principles ( e.g. , IFRS, US GAAP, etc.).

1.19 “ Penn-Novartis Collaboration ” shall mean that certain Collaboration and License Agreement entered by and between Penn and Novartis effective August 3, 2012, a redacted copy of which has been provided to Juno and St. Jude.

1.20 “ Penn Construct ” shall mean a CART-19 that includes [***].

1.21 “ Penn-Novartis Parties ” shall mean Penn and its Affiliates as well as Novartis and its Affiliates.

1.22 “ Permitted Sublicensees ” shall mean Third Parties that are permitted sublicensees of Novartis under the Penn-Novartis Collaboration that become sublicensed under the Penn-Novartis Collaboration to participate in the commercialization of products as contemplated by the Penn-Novartis Collaboration.

1.23 “ Person ” shall mean an individual, trust, corporation, partnership, joint venture, limited liability company, association, unincorporated organization or other legal or governmental entity.

1.24 “ Phase I Clinical Trial ” shall mean a human clinical trial, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients as required in 21 C.F.R. § 312, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States.

1.25 “ Phase II Clinical Trial ” shall mean (a) a human clinical trial, for which a primary endpoint is a preliminary determination of efficacy or dose ranges in patients with the disease target being studied as required in 21 C.F.R. § 312.21(b), as may be amended from time to time, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States, (b) a combined Phase I and Phase II Clinical Trial which [***], or (c) any Phase III Clinical Trial performed in lieu of a Phase II study.

1.26 “ Phase III Clinical Trial ” shall mean a human clinical trial, the principal purpose of which is to establish safety and efficacy in patients with the disease target being studied as required in 21 C.F.R. § 312, or similar clinical study prescribed by the regulatory authorities in a country other than the United States. A Phase III Clinical Trial shall also include any other human clinical trial intended as a pivotal study (a Phase II trial that provides evidence for a drug marketing approval), whether or not such study is a traditional Phase III study.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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1.27 “ Settlement Agreement ” shall mean that certain agreement entered by and between Juno, St. Jude, Penn and Novartis on the same date herewith, which is incorporated herein by reference.

1.28 “ St. Jude Agreement ” shall mean that certain Exclusive License Agreement entered by and between Juno and St. Jude effective December 3, 2013, a redacted copy of which is attached as Exhibit 1.28 hereto.

1.29 “ St. Jude-Juno Parties ” shall mean St. Jude and its Affiliates as well as Juno and its Affiliates.

1.30 “ Term of this Agreement ” shall have the meaning set forth in Section 12.01.

1.31 “ Territory ” shall mean the United States of America (“ U.S. ”), Including its territories and possessions.

1.32 “ Third Party ” shall mean any Person other than Juno or Novartis or any of their respective Affiliates.

1.33 “ Valid Claim ” as used herein, in either singular or plural, shall mean a claim of any issued and unexpired patent included within the Licensed Patents and (a) such claim has not been held permanently revoked, unenforceable or invalid by the final, un-reversed, and un-appealable, or unappealed within the time allowed for appeal, decision of a court or other government body of competent jurisdiction, has been irretrievably abandoned or disclaimed, and (b) such claim has not otherwise been finally admitted or determined to be invalid, unpatentable or unenforceable, whether through reissue, reexamination, disclaimer or otherwise. A pending claim of a patent application within the Licensed Patents which has been pending for a period of [***] or fewer years after filing shall also constitute a Valid Claim if (i) the claim continues to be prosecuted in good faith and has not been cancelled, withdrawn, abandoned or finally disallowed without the possibility of appeal or re-filing of such application, and (ii) there exists an issued Valid Claim for which the provisions of (a) and (b) are satisfied.

ARTICLE II

GRANTS

2.01 Sublicense to Licensed Patents . Subject to the terms and conditions of this Agreement, Juno hereby grants to Novartis and Affiliates of Novartis, and Novartis and Affiliates of Novartis hereby accept, a non-exclusive sublicense under the Licensed Patents for the Term of this Agreement to develop, have developed, make, have made, use, have used, import, offer for sale, have offered for sale, sell and have sold Licensed Products and Licensed Services, in each

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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case, in the Field in the Territory. Novartis and its Affiliates agree and acknowledge that the foregoing “have” rights will be exercised with Third Parties acting for the benefit of Novartis and/or its Affiliates in connection with the manufacture, development and/or commercialization of Licensed Products and Licensed Services that are owned or controlled by Novartis and/or its Affiliates, Including with respect to any CART-19 Suppliers of Novartis and its Affiliates. Subject to the terms and conditions of this Agreement, Juno hereby also grants to Penn, and Penn hereby accepts, a non-exclusive license under the Licensed Patents for the Term of this Agreement to make and use Licensed Products and to perform Licensed Services, in connection with research and development activities, Including clinical trials and studies, in each case, in the Field in the Territory; provided, however, that the exercise of any such rights by Penn is solely in support of the rights granted to Novartis under this Agreement.

2.02 Limited Sublicense Right . Novartis and Affiliates of Novartis may not grant or authorize any sublicense under the Licensed Patents without the express prior written consent of Juno, which consent may be granted or not granted in Juno’s discretion. For the avoidance of doubt, the foregoing shall not prevent Novartis from exercising the ‘have’ rights provided in Section 2.01 with respect to Licensed Products and/or Licensed Services. Novartis shall ensure that any Third Party that receives such a ‘have’ right will be bound by, and will abide by, the applicable terms of this Agreement. Penn may not grant or authorize any sublicense of the rights under the Licensed Patents granted to it hereunder without the express prior written consent of Juno, which consent may be granted or not granted in Juno’s discretion.

2.03 Reserved Rights . Novartis, Affiliates of Novartis, and Penn acknowledge that the Licensed Patents were made with funds provided by the United States Government, and the rights granted herein are subject to obligations to the U.S. Government set forth in the Bayh-Dole Act, 35 USC § 200 et seq. , Including an obligation to manufacture in the U.S. Licensed Products that will be sold in the U.S. In their practice of the sublicense to the Licensed Patents, Novartis, Affiliates of Novartis, and Penn agree to comply with all provisions of 35 USC § 200 et seq. and implementing regulations. Novartis, Affiliates of Novartis, and Penn further acknowledge that the St. Jude Agreement (a) reserves for St. Jude certain rights to practice the Licensed Patents, and (b) that Juno retains the right to practice the Licensed Patents and to grant one or more Third Parties licenses to the Licensed Patents (subject to the license rights granted to Novartis and Penn hereunder).

2.04 Sublicense; Supremacy of this Agreement . Novartis, Affiliates of Novartis, and Penn acknowledge that this Agreement provides a sublicense of patent rights exclusively licensed to Juno by St. Jude in the St. Jude Agreement. To the extent this Agreement deviates from the St. Jude Agreement, Juno acknowledges and consents to such deviations and agrees that this Agreement provides the definitive statement of terms and conditions applicable to Novartis, Affiliates of Novartis, and Penn, each as such rights and obligations are expressly set forth herein.

2.05 Limited License . Novartis, Affiliates of Novartis, and Penn each acknowledge and agree that (a) no license other than that expressly set forth in Section 2.01 is or shall be deemed to have been granted under this Agreement, whether by implication, estoppel or otherwise, and (b) the license granted under this Article II is limited in scope and does not confer on Novartis or its

 

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Affiliates or Penn or its Affiliates any license (express or implied) or any other rights to: (i) develop, make, have made, use, import, promote, distribute, market, sell, offer for sale or have sold any product that is not a Licensed Product, or any service that is not a Licensed Service, for any use or purpose; or (ii) develop, make, have made, use, import, promote, distribute, market, sell, offer for sale or have sold any Licensed Product or Licensed Service outside the Territory for any use or purpose.

2.06 No Implied Licenses . No license or other right is or shall be created or granted hereunder by implication, estoppel or otherwise. All licenses and rights are and shall be granted only as expressly provided in this Agreement. All rights not expressly granted by a Party under this Agreement are reserved by such Party and may be used by such Party for any purpose.

ARTICLE III

CONSIDERATION

3.01 Initial License Fee . Within [***] after the Effective Date, Novartis shall pay to Juno a license fee of twelve million two hundred fifty thousand U.S. dollars ($12,250,000).

3.02 Royalties .

(a) Running Royalties . Novartis shall pay to Juno running royalties of [***] percent ([***]%) of Net Sales of Licensed Products sold by Novartis, its Affiliates and Permitted Sublicensees in the Territory, Including where such sales occur in connection with the use of Licensed Products in the performance of Licensed Services.

(b) Other Royalties . In addition, Novartis shall pay to Juno [***] percent ([***]%) of the royalties that would be due under the royalty basis described in the attached Exhibit 3.02(b) , as if paid by Novartis to Penn for Net Sales of Licensed Products pursuant to the Penn-Novartis Collaboration (Including as such basis may be applied to Licensed Services as contemplated under this Agreement in the definition of Net Sales provided herein as well as Licensed Products, whether murine, human or other forms of CART19) as of the Effective Date. For example, and not by way of limitation, Novartis may owe Juno [***] percent ([***]%) of the [***] percent ([***]%) royalty expressed on the top left corner of the first Table expressed in Exhibit 3.02(b) ( i.e. , the top row of Table A in Exhibit 3.02(b) under the heading “I. Royalty Rate Applicable to any Initial CED-19 Product”), but applying the definition of Net Sales provided hereunder. Juno acknowledges and agrees that “royalty payments” as used in the foregoing sentence does not include [***]. Notwithstanding anything to the contrary, if Novartis and Penn agree at any time after the Effective Date to amend any aspect of the Penn-Novartis Collaboration that alters the terms for payment of royalties under the Penn-Novartis Collaboration, and such alteration would reduce the royalty payment owed to Penn, then such amended terms shall not in any manner reduce the royalty payment due to Juno under this Agreement determined as of the Effective Date; provided, however, if Novartis and Penn amend the Penn-Novartis Collaboration or otherwise enter into an agreement on or after the Effective Date that increases the royalty payment payable by Novartis to Penn pursuant to the Penn-Novartis Collaboration, then Exhibit 3.02(b) shall be deemed amended to reflect any such increase, and the royalty payment due to Juno shall be increased to correspond to the amended Exhibit 3.02(b) .

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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(c) Royalty Term . Royalties shall be due on a Licensed Product-by-Licensed Product basis, commencing on the First Commercial Sale of the applicable Licensed Product and continuing until the expiration or abandonment of the last applicable Valid Claim. Novartis’ obligation to pay royalties to Juno under this Agreement shall be imposed only once with respect to the same unit of Licensed Product, notwithstanding such Licensed Product may be covered by more than one Valid Claim of a Licensed Patent.

(d) [***]. The royalties due to Juno shall [***].

(e) Form of Consideration . Without the further prior express written consent of Juno, Novartis, its Affiliates and Permitted Sublicensees shall not solicit or accept any consideration for the sale of any Licensed Product, or the performance of any Licensed Service, other than as will be fully reflected in Net Sales.

(f) Royalty Payment . Novartis shall pay to Juno on [***] basis all royalties due and payable on Net Sales in each [***] pursuant to this Section 3.02 within [***] after the last day of each [***] in which the applicable Net Sales underlying such royalties were billed or invoiced by Novartis.

3.03 Milestone Payments . Within [***] after the first achievement of any of the following milestone events with regard to any Licensed Product, or within [***] after the Effective Date for those milestone events that have already been achieved as of the Effective Date, Novartis shall notify Juno of such achievement. Novartis shall concurrently with the applicable notice pay to Juno the payment in the applicable amounts set forth in this Section 3.03 (each an “ Event Payment ”).

 

(a) [***]:

   $[***]

(b) [***]:

   $[***]

(c) [***]:

   $[***]

(d) [***]:

   $[***]

(e) [***]:

   $[***]

(f) [***]:

   $[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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3.04 Milestone Payment Adjustments . With respect to each of the Event Payments specified in Section 3.03, the amount payable by Novartis shall be adjusted as follows:

(a) If, as between Novartis and Juno, Novartis is the first Party to achieve the milestone event, then Novartis shall pay to Juno the relevant Event Payment pursuant to the terms described in Section 3.03. If after Novartis reaches the milestone event, Juno also achieves the milestone event, Juno shall reimburse to Novartis fifty percent (50%) of the Event Payment actually paid by Novartis to Juno.

(b) If, as between Novartis and Juno, Novartis is the second Party to achieve the milestone event, then Novartis shall pay to Juno fifty percent (50%) of the relevant Event Payment pursuant to the terms described in Section 3.03.

(c) Within [***] after the first achievement by Juno of any milestone event, or within [***] after the Effective Date for those milestone events that have already been achieved by Juno as of the Effective Date, Juno shall notify Novartis of such achievement. Juno shall concurrently with the applicable notice reimburse Novartis as set forth in Section 3.04(a).

3.05 Non-creditable Payments . Subject to Sections 3.03 and 3.04, all payments made to Juno pursuant to this Article III shall be [***] and shall not be creditable against any other amount due to Juno pursuant to this Agreement.

3.06 Other Consideration .

(a) Past Acknowledgement

(i) New England Journal of Medicine . Within [***] after the Effective Date, Penn shall submit to New England Journal of Medicine [***] the letter to the editor attached hereto as Exhibit 3.06(a)(i) .

(ii) Science Translational Medicine . Within [***] after the Effective Date, Penn shall submit to Science Translational Medicine for [***] the letter to the editor attached hereto as Exhibit 3.06(a)(ii) .

(iii) Other Publications . Subject to Section 3.06(d), Penn shall provide St. Jude and Juno with copies of all publications dating prior to the Effective Date which report a study involving Penn’s use of the Penn Construct. [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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[***].

(b) Future Acknowledgement . Subject to Section 3.06(d), during a [***] time period commencing on the Effective Date, all future publications authored, co-authored or released by Penn or by any then-current Penn faculty member or employee, which report a study involving Penn’s use of the Penn Construct shall include the following acknowledgement:

[***].

(c) Notification of Transfers and Provision of Agreements . Novartis and Penn shall not seek to obstruct or interfere with St. Jude or Juno if St. Jude or Juno attempts to communicate with any Third Party listed in Exhibit 8.03(d) or Exhibit 8.03(e) .

(d) Except as provided elsewhere in this Agreement, the parties agree that any Penn Construct first made [***].

ARTICLE IV

GENERAL FINANCIAL MATTERS AND REPORTS

4.01 Royalty Reports . Commencing with the First Commercial Sale and for the remaining Term of this Agreement, Novartis shall submit [***] to St. Jude and Juno a written royalty report (“ Royalty Report ”), in the form provided in Exhibit 4.01 , covering sales of each Licensed Product for each [***] with the following information for each of Novartis, its Affiliates and Permitted Sublicensees, on a Licensed Product-by-Licensed Product basis:

(a) [***];

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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(b) [***];

(c) [***]; and

(d) [***].

Royalty Reports shall be provided to Juno for the Territory no later than [***] after the end of the [***] to which they pertain.

4.02 Timing of Royalty Payments . Novartis shall make any royalty payments due pursuant to Article III concurrently with Novartis’s provision of the Royalty Report required by Section 4.01 for the relevant [***].

4.03 Records . Novartis, its Affiliates and Permitted Sublicensees shall keep and maintain true and accurate records, files and books of account of all sales of all Licensed Products in the Territory for at least [***] after the [***] in which such Net Sales are made, in sufficient detail to permit Juno to confirm the accuracy of Net Sales and royalty calculations, a full computation and verification of sales and other information required in Section 4.01 by Novartis. Such books and records shall be in accordance with Novartis Accounting Standards, consistently applied.

4.04 Audit . At Juno’s request and expense, Novartis shall permit an independent nationally recognized certified public accountant appointed by Juno and approved by Novartis (such approval not to be unreasonably withheld or delayed) to examine at a mutually agreeable location in New York, New York, United States of America, or another city as to which Juno and Novartis may mutually agree, upon reasonable notice and at reasonable times, Novartis’s records to verify Net Sales calculations (Including the details of all deductions taken from gross invoiced sales price to arrive at Net Sales) and royalty calculations made by Novartis. Any such examination shall occur during regular business hours upon [***] written notice to Novartis but not more than once in a twelve (12) month period. The appointed accountant shall enter into a confidentiality agreement with Novartis upon terms comparable to those in Article XI, which confidentiality agreement shall continue to apply to any information provided to such accountant for the examination unless and until such information (a) becomes generally available to the public other than through any breach of the confidentiality agreement by such accountant, or (b) becomes known to such accountant other than from or through a Person having an obligation to Novartis not to disclose such information. Novartis shall provide the appointed accountant access to such records that in the ordinary course of business are in the possession, custody or control of Novartis, its Affiliates and Permitted Sublicensees. Novartis shall also cause each of its Affiliates and Permitted Sublicensees to make available for inspection by the appointed accountant, at a mutually convenient location in the United States, true, complete and accurate records of Affiliate’s and/or Permitted Sublicensees’ sales of all Licensed Products and Licensed Services in sufficient detail to permit Juno to confirm the accuracy of Novartis’s Net Sales calculations and royalty calculations based on such Affiliate’s or Permitted Sublicensees’ sales. The report of any such examination shall be made simultaneously to Juno, St. Jude and Novartis, and shall include a

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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statement of the amount, if any, by which Novartis has underpaid or overpaid its royalties, and the nature and basis of the underpayment or overpayment. The decision of the auditor shall be final, binding and incontestable. In the event of an underpayment of royalties, Novartis shall promptly pay the deficiency plus interest pursuant to Section 4.07 to Juno; and if royalties to Juno were underpaid by [***] in any [***], then Novartis shall additionally reimburse Juno for its reasonable costs incurred in examining such records.

4.05 Payments . All amounts owed by Novartis to Juno under this Agreement shall be paid in U.S. dollars by wire transfer of immediately available funds to such bank account as Juno may from time to time designate in writing.

4.06 Exchange Rates . If by law, regulations or fiscal policies, remittance of royalties in Dollars is prohibited or restricted, Novartis will notify Juno and payment of the royalty obligations shall be made by deposit thereof in local currency to the credit of Juno in a recognized banking institution designated by Juno.

4.07 Late Payments; Interest . In the event that any payment due hereunder is not made when payable, the payment shall accrue interest beginning on the [***] following the due date thereof, calculated at the rate of [***] per month from the date said payment is due, provided however, said annual interest rate shall not exceed the maximum legal interest rate for corporations. Each such payment when made shall be accompanied by all interest so accrued. The payment of any such interest and acceptance thereof shall not negate or waive the right of Juno to seek any other remedy, legal or equitable, to which it may be entitled because of the delinquency of any payment Including termination of this Agreement.

4.08 Taxes

(a) Withholding Taxes . [***].

(b) Other Taxes . Any sales taxes ( e.g. , consumption or value added taxes), use taxes, transfer taxes, value added, duties and other taxes or governmental charges required to be paid with regard to any Licensed Products or Licensed Services shall be the sole responsibility of Novartis. In the event that Juno is required to pay any such amounts, Novartis shall promptly remit payment to Juno of such amounts following receipt of an invoice therefor.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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4.09 Finality . Novartis hereby releases and forever waives any right to challenge or dispute any amounts paid or owed on Licensed Products pursuant to the terms and conditions of this Agreement, except to the extent Juno and Novartis have a disagreement with respect to the calculation of Net Sales or the timing of the royalty payments owed on Net Sales or any milestone payments due hereunder.

ARTICLE V

SETTLEMENT OF THE LITIGATION

5.01 Contemporaneously with the execution of this Agreement, the Parties (together with St. Jude) shall execute the Settlement Agreement, which is incorporated herein by reference.

5.02 Within five (5) days after the execution of the Settlement Agreement, the Parties (together with St. Jude) shall file a dismissal with prejudice of all claims and counterclaims asserted in the Litigation by filing the form of dismissal attached hereto as Exhibit 5.02 . Novartis, Juno, and Penn agree that in the event the Licensed Patents, Including any liability thereunder, are ever asserted against any of Penn or Novartis, or their respective Affiliates, or any of their respective assigns or successors in interest, by any of Juno or St. Jude, or their respective Affiliates, or any of their respective assigns or successors in interest, Penn, Novartis, their respective Affiliates and their respective assigns or successors in interest expressly reserve the right to assert non-infringement, invalidity and unenforceability of the Licensed Patents, either by way of counterclaim or defense.

ARTICLE VI

LIMITED LITIGATION STANDSTILL

6.01 During the time period commencing on the Effective Date and extending through the later of [***], and only during such period, except for any breach of this Agreement, (a) none of the St. Jude-Juno Parties may file, assist in the filing of, or otherwise support, encourage, or be involved in the filing or maintenance of (i) any action, lawsuit, arbitral proceeding, or the seeking of an investigation under the Tariff Act of 1930 (“ Action ”), Including the filing of any infringement or declaratory judgment action, against any of the Penn-Novartis Parties or their CART-19 Suppliers with respect to any CART-19 product or service (or any component thereof) or (ii) any review by a court, administrative agency or any other forum of any patent or patent application owned or controlled by the Penn-Novartis Parties relating to any CART-19 product or service (or any component thereof), and (b) none of the Penn-Novartis Parties may file, assist in the filing of, or otherwise support, encourage, or be involved in the filing or maintenance of (i) any Action, Including the filing of any infringement or declaratory judgment action, against any of the St. Jude-Juno Parties or their CART-19 Suppliers with respect to any CART-19 product or service (or any component thereof) or (ii) any review by a court, administrative agency or any other forum of any patent or patent application owned or controlled by the St. Jude-Juno Parties relating to any CART-19 product or service (or any component thereof).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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6.02 During the time period commencing upon the expiration of the time period set forth in Section 6.01 and continuing until [***], prior to any of the St. Jude-Juno Parties, on the one hand, or any of the Penn-Novartis Parties, on the other hand, (collectively, as applicable, the St. Jude-Juno Parties or the Penn-Novartis Parties as a group, the “ Litigating Parties ”) filing, assisting in the filing of, or otherwise supporting, encouraging, or being involved in the filing or maintenance of any (a) Action, Including the filing of any infringement or declaratory judgment action, against any of the Penn-Novartis Parties (in the case of the St. Jude-Juno Parties as the Litigating Parties) or any of the St. Jude-Juno Parties (in the case of the Penn-Novartis Parties as the Litigating Parties), as applicable (collectively, as applicable, the Penn-Novartis Parties or the St. Jude-Juno Parties as a group, the “ Responding Parties ”), with respect to any CART-19 product or service (or any component thereof), or (b) any review by a court, administrative agency or any other forum of any patent or patent application owned or controlled by the Responding Parties relating to any CART-19 product or service (or any component thereof), the Litigating Parties shall give the Responding Parties at least [***] notice and during such [***] period of time such parties shall engage in discussions regarding such potential Action or such review by a court, administrative agency or any other forum to see if such parties may be able to settle the matter without engaging in such potential Action or court, administrative agency or any other forum review. However, if no such settlement is reached in a definitive written agreement, (i) the Litigating Parties shall no longer be restrained by this Section 6.02 with regard to the Action or court, administrative agency or any other forum review with respect to which it gave notice to the Responding Parties, and (ii) both the Responding Parties and the Litigating Parties shall be free to raise whatever related defenses and make additional assertions as they otherwise would in the conduct of such matters without having to give notice under or otherwise being restrained by this Section 6.02, provided it is understood and agreed that during the [***] period following the end of such [***] period, only the Litigating Parties (and not the Responding Parties) may file or assist in the filing of such Action or court, administrative agency or any other forum review.

6.03 Notwithstanding anything to the contrary and for the avoidance of doubt:

(a) any damages that may be available based on any alleged infringement or related claims specific to any CART-19 product or service (or any component thereof) will continue to accrue during the Term of this Agreement, Including during any notice or longer periods of negotiations occurring under Section 6.02;

(b) a Party’s agreement to, or compliance with, the terms of this Article VI during the Term of this Agreement will not be deemed or construed to (i) grant or exhaust any patent rights (whether express or implied), or (ii) waive any rights, damages, or remedies that would otherwise be available; and

(c) during the Term of this Agreement all time-based defenses ( e.g. , statutes of limitations and laches) to any Action or any review by a court, administrative agency or any other forum that are subject to Section 6.01 and/or Section 6.02, Including calculations of time thereunder and the running of any deadlines associated therewith, will be tolled only for the duration of any standstill provided for in Section 6.01 and/or Section 6.02, as applicable.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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ARTICLE VII

PATENT CHALLENGE

7.01 Challenge to Validity/Enforceability of Licensed Patents by an Assertion Entity. No Assertion Entity shall First Assert any challenge to the validity or enforceability of any Licensed Patent(s) in any court, administrative agency or any other forum (“ Challenge ”). Any breach of the foregoing shall be deemed a material breach of this Agreement, as a result of which Juno may, at its sole discretion, terminate this Agreement with notice to Novartis. In the event of such termination by Juno, the sublicense granted herein to Novartis shall terminate immediately. If any Assertion Entity commences any Challenge while this Agreement remains in force, Juno, in its sole discretion, may terminate this Agreement. If Juno determines not to terminate the Agreement, then the Assertion Entity shall reimburse Juno for any and all costs and expenses incurred by Juno in defense and settlement of such proceedings (Including damages, settlement payments, attorneys’ fees, expert witness fees and court costs). Such reimbursements shall be paid by the Assertion Entity within [***] after each invoice for such costs and expenses is submitted to the Assertion Entity by Juno or Juno’s counsel. Failure to timely reimburse such costs and expenses will constitute a material breach of this Agreement. In addition, any payments required hereunder must be timely made in full when due, in cash and readily available funds; and once paid, no such amounts will be subject to replevin, refund or recovery by the Assertion Entity, its Affiliates or Permitted Sublicensees, irrespective of whether such challenge was successful.

ARTICLE VIII

REPRESENTATIONS, WARRANTIES AND COVENANTS;

DISCLAIMER; LIMITATION OF LIABILITY

8.01 Representations by Juno . Juno represents and warrants to the other Parties that:

(a) as of the Effective Date Juno is a corporation, duly organized, validly existing and in good standing under the laws of State of Delaware;

(b) the execution, delivery and performance of this Agreement has been duly authorized by all necessary corporate action on the part of Juno;

(c) the execution, delivery and performance of this Agreement shall not conflict in any material fashion with the terms of any other agreement or instrument to which it is or becomes bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority;

(d) it has the right to grant the sublicense under the Licensed Patents set forth in this Agreement; and

(e) as of the Effective Date, Juno is not a party to any action, lawsuit, arbitral proceeding or administrative proceeding against Penn and/or Novartis other than the Litigation.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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8.02 Representations by Novartis . Novartis represents and warrants to the other Parties that:

(a) as of the Effective Date Novartis is a corporation, duly organized, validly existing and in good standing under the laws of Switzerland;

(b) the execution, delivery and performance of this Agreement has been duly authorized by all necessary corporate action on the part of Novartis;

(c) the execution, delivery and performance of this Agreement shall not conflict in any material fashion with the terms of any other agreement or instrument to which it is or becomes bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority;

(d) as of the Effective Date, it is not a party to any action, lawsuit, arbitral proceeding or administrative proceeding against St. Jude and/or Juno other than the Litigation; and

(e) it acknowledges and agrees that as of the Effective Date ( i.e., as the Licensed Patents and Valid Claims thereunder exist as of the Effective Date), [***], as defined under this Agreement.

8.03 Representations by Penn . Penn represents and warrants to the other Parties that:

(a) as of the Effective Date Penn is a nonprofit corporation organized, validly existing and in good standing under the laws of Commonwealth of Pennsylvania;

(b) the execution, delivery and performance of this Agreement has been duly authorized by all necessary corporate action on the part of Penn;

(c) the execution, delivery and performance of this Agreement shall not conflict in any material fashion with the terms of any other agreement or instrument to which it is or becomes bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority;

(d) Subject to Section 3.06(d), Exhibit 8.03(d) contains a true and complete list of the names, affiliations, and addresses of any and all Third Parties to whom the Penn Construct has been provided by Penn;

(e) Exhibit 8.03(e) contains a true and complete list of the names, affiliations, and addresses of any and all Third Parties with whom Penn has entered into any agreement(s) relating to actual commercialization involving the Penn Construct;

(f) as of the Effective Date, Penn is not a party to any action, lawsuit, arbitral proceeding or administrative proceeding against St. Jude and/or Juno other than the Litigation; and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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(g) Penn acknowledges and agrees that as of the Effective Date ( i.e., as the Licensed Patents and Valid Claims thereunder exist as of the Effective Date), [***], as defined under this Agreement.

8.04 Disclaimer of Warranties . Nothing in this Agreement is or shall be construed as:

(a) A warranty or representation by Juno as to the scope, validity or enforceability of any claim or patent or patent application within the Licensed Patents;

(b) A warranty or representation by Juno that anything made, used, offered for sale, sold or otherwise disposed of by Novartis, its Affiliates or Permitted Sublicensees under any sublicense granted in this Agreement is or will be free from infringement of any patent rights or other intellectual property right of any Third Party or any other patent rights or other intellectual property owned or controlled by Juno;

(c) A grant by Juno, whether by implication, estoppel or otherwise, of any licenses other than those expressly granted under Article II; or

(d) An obligation on the part of Juno to bring or prosecute actions or suits against any Third Party for infringement of any of the Licensed Patents.

8.05 Further Disclaimers . EXCEPT AS OTHERWISE PROVIDED HEREIN, THE LICENSED PATENTS ARE LICENSED “AS IS”, AND JUNO SPECIFICALLY DISCLAIMS ANY EXPRESS OR IMPLIED WARRANTY (EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE) OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR PATENTABILITY, VALIDITY, OR ENFORCEABILITY OF THE LICENSED PATENTS, OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY OWNED BY A THIRD PARTY ARISING FROM ANY PRACTICE OF THE LICENSED PATENTS. JUNO FURTHER DISCLAIMS ALL WARRANTIES WITH REGARD TO LICENSED PRODUCT(S) USED, MADE OR SOLD AND/OR LICENSED SERVICES PERFORMED BY NOVARTIS, ITS AFFILIATES OR PERMITTED LICENSEES INCLUDING, BUT NOT LIMITED TO, THEIR SAFETY, EFFECTIVENESS OR COMMERCIAL VIABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE

ARTICLE IX

LIMITATION OF LIABILITY

9.01 Limitation of Liability . NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, JUNO AND EACH OF THE INVENTORS OF THE LICENSED PATENTS SHALL HAVE NO LIABILITIES FOR DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL, AND CONSEQUENTIAL DAMAGES, ATTORNEYS’ AND EXPERTS’ FEES, AND COURT COSTS (EVEN IF SUCH ENTITIES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE,

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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IMPORTATION, OFFER FOR SALE OR SALE OF ANY LICENSED PRODUCT(S) AND/OR LICENSED SERVICES BY OR ON BEHALF OF NOVARTIS, ITS AFFILIATES OR PERMITTED SUBLICENSEES. NOVARTIS HEREBY ASSUMES ALL RESPONSIBILITY AND LIABILITY FOR ANY LOSS, LIABILITY OR DAMAGE CAUSED BY ANY LICENSED PRODUCT OR LICENSED SERVICE BY OR ON BEHALF OF NOVARTIS, ITS AFFILIATES OR PERMITTED SUBLICENSEES.

ARTICLE X

INDEMNIFICATION; INSURANCE

10.01 Indemnification for Breach of Warranty . Any Party that breaches any warranty or covenant set forth in Article VIII shall indemnify, defend and hold harmless the other Parties and their respective Affiliates, and each of their respective directors, officers, employees and agents, from and against any and all liabilities, claims, demands, expenses (Including reasonable attorneys’ and professional fees and other costs of litigation), losses or causes of action arising out of or relating to any such breach of warranty.

10.02 Indemnification of Juno Indemnitees . Novartis shall, indemnify, defend, with counsel reasonably acceptable to Juno, and hold Juno, its Affiliates, and each of their respective directors, officers, employees and agents (each a “ Juno Indemnitee ”) harmless from and against any and all liabilities, claims, demands, judgments, expenses (Including reasonable attorneys’ and professional fees and other costs of litigation), losses or causes of action (each, a “ Liability ”) a Juno Indemnitee may be required to pay to one or more Third Parties to the extent resulting from or arising out of [***].

10.03 Indemnification of St. Jude Indemnitees . Novartis shall, indemnify, defend, with counsel reasonably acceptable to St. Jude, and hold St. Jude, the American Lebanese Syrian Associated Charities, Inc. (ALSAC; a non-profit, 501(c)(3) corporation which supports St. Jude), their present and former trustees, directors, governors, officers, agents, and the Inventors, and the faculty, employees and students of St. Jude, (collectively, the “ St. Jude Indemnitees ”), harmless from and against any Liability a St. Jude Indemnitee may be required to pay to one or more Third Parties to the extent resulting from or arising out of [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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[***].

10.04 Insurance . Novartis shall maintain in full force and effect, at its sole cost and expense, and at all times during the Term of this Agreement commercial general liability insurance, Including contractual liability, with limits of not less than [***] for bodily injury and personal injury, Including death, and property damage, and [***]. Notwithstanding the foregoing, Novartis shall maintain throughout the Term of this Agreement products/completed operations liability coverage in an amount no less than [***]. Novartis shall also maintain other policies of insurance or programs of self-insurance of the types and in the amounts customarily carried by their respective businesses to fulfill their obligations stated within this Agreement. Novartis warrants that neither a program of self-insurance nor the limits stated within its insurance policy(ies) will affect or limit its liability or indemnity obligations stated elsewhere in this Agreement or as required by law. Upon execution of this Agreement and annually thereafter upon request, Novartis shall provide the other with evidence of their liability insurance. Novartis shall evidence its general commercial and products/completed operations liability insurance to Juno using a Memorandum of Insurance (MOI) website link.

ARTICLE XI

CONFIDENTIALITY

11.01 Confidentiality . Novartis, Juno and Penn may exchange information in connection with this Agreement that they consider to be confidential, Including any reports or information provided by Novartis pursuant to Article IV, each of which Novartis considers to be confidential, (collectively, “ Confidential Information ”). Information will be treated as Confidential Information, if in written form, it is marked in writing as “confidential” at the time of disclosure, and other information disclosed orally or in non-tangible form is (x) identified by the disclosing Party as “confidential” at the time of disclosure and (y) within thirty (30) days thereafter, the disclosing Party provides a written summary of such other information marked as “confidential.” Each recipient of such information agrees to accept the disclosure of said Confidential Information and agrees to employ all reasonable efforts to maintain the Confidential Information secret and confidential, such efforts to be no less than the degree of care employed by the recipient to preserve and safeguard its own confidential information. The Confidential Information shall not be disclosed or revealed to anyone except officers, directors, employees and contractors of the recipient who (a) have a need to know the Confidential Information, (b) are subject to obligations of confidentiality and non-use substantially similar to those set forth in this Article XI, and (c) have been advised by the recipient of the confidential nature of the Confidential Information and that the Confidential Information shall be treated accordingly.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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11.02 Exceptions . The recipient’s obligations under Section 11.01 shall not extend to any part of the Confidential Information:

(a) that can be demonstrated to have been in the public domain or publicly known and readily available to the trade or the public prior to the date of the disclosure; or

(b) that can be demonstrated, from written records to have been in the recipient Party’s possession or readily available to the recipient Party from another source not under obligation of secrecy to the disclosing Party prior to the disclosure; or

(c) that becomes part of the public domain or publicly known by publication or otherwise, not due to any unauthorized act by the recipient Party; or

(d) that is demonstrated from written records to have been developed by or for the receiving Party without reference or access to Confidential Information disclosed by the disclosing Party; or

(e) that is required to be disclosed by law, government regulation or court order.

11.03 Permitted Disclosures . Each Party agrees not to disclose any of the terms of this Agreement or any of the information contained in reports pursuant to Article IV of this Agreement to any Person without the prior written consent of each of the other Parties; provided, however, that each Party shall be free to disclose, notwithstanding the prior written consent requirement set forth in Section 13.10, any such terms or information (a) to the extent that the Party is required to make such disclosure by order or regulation of a government agency, court or other tribunal having jurisdiction, except that to the extent permitted by law such Party shall not make any such disclosure (other than a filing of information or materials with the U.S. Securities and Exchange Commission or an equivalent authority in another jurisdiction or a relevant stock exchange that is made with a request for confidential treatment for any part of such disclosure for which such treatment may reasonably be expected to be granted, provided that the Party requesting confidential treatment discloses to the other Parties the substance of the request for confidential treatment prior to making the request) without first notifying each other Party and allowing the other Parties a reasonable opportunity to seek a protective order or injunctive relief from the obligation to make such disclosure, or (b) to its Affiliates, accountants, attorneys and other professional advisors, provided that such entities and/or individuals are obligated to keep such terms confidential to the same extent as said Party. All written reports provided by Novartis to Juno pursuant to this Agreement shall be Confidential Information of Novartis; provided that Juno may disclose (i) such reports to St. Jude as well as the contents of this Agreement, in each case, to comply with the St. Jude Agreement and (ii) to St. Jude any other information received by it under or in connection with this Agreement; provided that, in each case of (i) and (ii), St. Jude shall, pursuant to Section 6.4 of the Settlement Agreement, agree to be obligated to keep such disclosures confidential to the same extent as Juno under the terms of this Agreement.

 

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11.04 Survival . The confidentiality terms of this Article XI shall survive any expiration of this Agreement for [***].

ARTICLE XII

TERM AND TERMINATION

12.01 Term . This Agreement will commence on the Effective Date and, unless terminated earlier as provided in this Article XII, will remain in full force and effect and continue until there are no remaining payment obligations due under this Agreement (“ Term of this Agreement ”).

12.02 Termination for Cause . As between Juno and Novartis, if either Juno or Novartis materially breaches this Agreement, the non-breaching party may elect to give the breaching party written notice describing the alleged breach. If the breaching party has not cured such breach within [***] after receipt of such notice, the non-breaching party will be entitled, in addition to any other rights it may have under this Agreement, to terminate this Agreement effective immediately. In no event, however, shall such notice or intention to terminate be deemed to waive any rights to damages or any other remedy which the Party giving notice of breach may have as a consequence of such failure or breach. The cure period provided in this Section 12.02 will not have the effect of delaying the due date of payments required hereunder; accordingly, the failure to make full timely payments hereunder for any [***] out of [***] will be conclusively deemed not curable. In addition, if the appointed accountant in any [***] consecutive audits under Section 4.04 determines that (a) the unpaid amounts for any royalty reporting period exceeds [***] of the royalties paid by Novartis for such royalty reporting period, or (b) Novartis failed to comply with its obligations under Article IV, Juno may terminate this Agreement upon written notice. For the avoidance of doubt, and subject to this Section 12.02, breach of any provision of Article III or Article VI shall constitute material breach under this Section 12.02.

12.03 Termination by Novartis . Novartis may terminate this Agreement and the license granted herein for any reason, upon giving Juno [***] written notice. All payments made pursuant to Article III through the date of such termination shall be [***].

12.04 Insolvenc y. This Agreement may be terminated by a Party in the event that another Party, to the extent permissible under applicable and prevailing law, files or has filed against it a petition under the U.S. Bankruptcy Act, makes an assignment for the benefit of creditors, has a receiver appointed for it or a substantial part of its assets or otherwise takes advantage of any statute or law designed for relief of debtors.

12.05 Effect of Termination .

(a) Accrued Rights and Obligations . Termination of this Agreement for any reason shall not release any Party hereto from any liability which, at the time of such termination, has already accrued to the other Parties or which is attributable to a period prior to such termination, nor preclude any Party from pursuing any rights and remedies it may have hereunder or at law or in equity which accrued or are based upon any event occurring prior to such termination.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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(b) Termination of Sublicense . Upon any termination of this Agreement, the sublicense granted to Novartis, its Affiliates, and Penn in Section 2.01 shall terminate, and any sublicenses granted under Section 2.02 shall terminate concurrently.

(c) Return of Confidential Information . Upon any termination of this Agreement, each Party shall promptly return to the other Parties all Confidential Information received from the applicable other Parties (except one copy of which may be retained for archival purposes).

12.06 Survival . Articles I, IV, IX, X, XI, and XIII and Sections 2.06, 5.02, 8.04, 8.05, 12.05 and 12.06 of this Agreement shall survive termination of this Agreement for any reason.

ARTICLE XIII

MISCELLANEOUS PROVISIONS

13.01 Relationship of the Parties . Nothing in this Agreement is intended or shall be deemed to constitute or give rise to a partnership, agency, distributorship, employer-employee, joint venture or fiduciary relationship between the Parties. Each Party shall be liable for any failure by its Affiliates to comply with the restrictions, limitations, and obligations set forth in this Agreement. No Party shall permit any of its Affiliates to commit any act (Including any act or omission) that such Party is prohibited hereunder from committing directly. No Party shall incur any debts or make any commitments for the other. No Party owes any of the other Parties any fiduciary duties in connection with this Agreement. This Agreement is solely for the benefit of the Parties and no provision of this Agreement shall be deemed to confer upon any Third Parties any remedy, claim, liability, reimbursement, claim of action or other right in excess of those existing without reference to this Agreement.

13.02 Patent Prosecution and Enforcement . Novartis shall have no rights with respect to the prosecution, defense, and maintenance of the Licensed Patents (Including whether to undertake such activities), nor shall Novartis have any rights with respect to enforcing the same against actual or suspected Third Party infringers (Including whether to undertake such activities).

13.03 Severability . In the event that any provisions of this Agreement are determined to be invalid or unenforceable by a court of competent jurisdiction, the remainder of the Agreement shall remain in full force and effect without said provision. The Parties shall in good faith negotiate a substitute clause for any provision declared invalid or unenforceable, which shall most nearly approximate the intent of the Parties in entering this Agreement.

13.04 Waiver of Breach or Default . The waiver by a Party of any breach of or default under any of the provisions of this Agreement or the failure of a Party to enforce any of the provisions of this Agreement or to exercise any right hereunder shall not constitute or be construed as a waiver of any other breach or default or as a waiver of any such rights or provisions hereunder.

 

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13.05 Assignment . No Party shall assign this Agreement, or any rights or obligations of such Party, except: (a) as incident to the merger, consolidation, reorganization or acquisition of stock or assets affecting substantially all of the assets or voting control of the assigning Party; (b) to any Person to which it transfers all or substantially all of its assets related to Licensed Products; (c) to an Affiliate if the assigning Party remains liable and responsible for the performance and observance of all of the Affiliate’s duties and obligations hereunder; or (d) with the prior written consent of each other Party (which consent shall not be unreasonably withheld). A Party making an assignment shall promptly give written notice thereof to each other Party. This Agreement, and rights and obligations hereunder, shall be binding upon the successors and permitted assigns of the Parties, and the name of a Party appearing herein shall be deemed to include the names of such Party’s successor’s and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any assignment not in accordance with this Section 13.05 shall be void.

13.06 Trade Names and Trademarks . Except as otherwise provided herein, no right, expressed or implied, is granted by this Agreement to use in any manner the name “Juno” or any other trade name or trademark of Juno in connection with the performance of this Agreement or otherwise. Except as otherwise provided herein, no right, expressed or implied, is granted by this Agreement to use in any manner the name “Novartis” or any other trade name or trademark of Novartis in connection with the performance of this Agreement or otherwise. Except as otherwise provided herein, no right, expressed or implied, is granted by this Agreement to use in any manner the name “Penn” or any other trade name or trademark of Penn in connection with the performance of this Agreement or otherwise. Except as otherwise provided herein, no right, expressed or implied, is granted by this Agreement to use in any manner the name “St. Jude” or any other trade name or trademark of St. Jude in connection with the performance of this Agreement or otherwise.

13.07 Dispute Resolution . Except as otherwise expressly provided in this Agreement, any dispute, controversy or claim arising out of or in connection with or relating to this Agreement or the breach or alleged breach thereof (Including any dispute regarding arbitrability), but not including any dispute, controversy or claim concerning the patentability, validity, enforceability, or infringement of any patent, shall be finally and exclusively decided by binding arbitration by JAMS pursuant to its Comprehensive Arbitration Rules. The arbitration shall be held in Chicago, Illinois. The arbitration panel shall be comprised of three (3) independent, conflict-free arbitrators. The Parties shall endeavor to select all three (3) such arbitrators by mutual agreement within [***] of the failure of the Parties to resolve the matter. If the Parties are unable to do so, Juno shall appoint one (1) independent, conflict-free arbitrator, Novartis and Penn shall together appoint one (1) independent, conflict-free arbitrator, and a third independent, conflict-free arbitrator shall be selected and appointed by the two appointed arbitrators. If the Parties’ appointed arbitrators fail to agree on the identity of such third arbitrator within [***] from the date both Parties’ arbitrators have been appointed, then such third arbitrator shall be appointed by the appropriate administrative body of JAMS from its list of authorized arbitrators, which arbitrator shall have substantial prior experience arbitrating contract, licensing and patent disputes. The Parties shall have the right to conduct discovery as provided for

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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in the Federal Rules of Civil Procedure. All discovery shall be completed within [***] following the appointment of the arbitrators. The arbitrators’ decision and award in the arbitration shall be in writing setting forth the basis therefor and shall be rendered within [***] following the appointment of the arbitrators. The award rendered by the arbitrators shall include costs of the arbitration, reasonable attorneys’ fees, and reasonable costs for experts and other witnesses, and judgment on the award may be entered in any court having jurisdiction. To the extent permitted by law, the arbitration proceeding and arbitrator’s decision shall be confidential and the arbitrators shall issue appropriate protective orders to safeguard each Party’s confidential information. Nothing in this Agreement shall be deemed as preventing a Party from seeking temporary injunctive relief (or any other provisional remedy) from any court having jurisdiction over the Parties and the subject matter of the dispute but only to the extent necessary to protect such Party’s name, confidential information, or other similar proprietary rights, or to prevent any imminent irreparable harm. Each Party hereby consents to the personal jurisdiction and venue of any court of competent jurisdiction in the United States for purposes of entering judgment on the arbitration award.

13.08 Choice of Law . The validity, performance, construction, and effect of this Agreement and any arbitration conducted under Section 13.07 shall be governed by and interpreted in accordance with the laws of the State of New York without regard to conflict of laws principles, except that the validity, performance, construction and effect of patent-related terms of Article VI shall be governed by and interpreted in accordance with Federal Circuit law.

13.09 Notices . Any notice, request, consent or other document required or permitted to be given under this Agreement or otherwise relating to this Agreement shall be in writing and shall be deemed to have been sufficiently given if delivered in person, or sent by overnight courier or registered mail to the Party to whom it is directed at its address shown below or such other address as such Party shall have last given by notice to each other Party. Any such notice, request, delivery, approval or consent shall be deemed received on the date of hand delivery (provided that such date is a Business Day, otherwise it shall be deemed received on the next Business Day), or one (1) Business Day after dispatch by overnight courier, or five (5) Business Days after dispatch by registered mail.

If to Novartis, addressed to each of:

Novartis AG

CH-4056

Basel, Switzerland

Attn: Group General Counsel

Notices to Novartis, to each of:

Novartis Pharmaceuticals Corporation

One Health Plaza

East Hanover, New Jersey 07936

Attention: General Counsel

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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Novartis Institutes of Biomedical Research, Inc.

250 Massachusetts Avenue

Cambridge, Massachusetts 02139

Attention: General Counsel

The Trustees of the University of Pennsylvania

133 South 36th Street, Suite 300

Philadelphia, PA 19104

Attention: General Counsel

With a copy to (which alone shall not constitute notice):

Morgan, Lewis & Bockius LLP

1701 Market Street

Philadelphia, PA 19103

Attention: Eric Kraeutler, Esq.

If to Juno, addressed to:

Juno Therapeutics, Inc.

307 Westlake Avenue North, Suite 300

Seattle, WA 98109

United States of America

Attn: General Counsel

13.10 Publicity . Other than the press releases attached hereto as Exhibit 13.10(a) and Exhibit 13.10(b) , no Party shall issue any press release or other publicity material or make any public representation that refers to the existence of this Agreement without the prior written consent of the each of the other Parties (which consent shall not be unreasonably withheld or delayed), except with respect to the financial terms of the Agreement, which shall not be disclosed without the prior written consent of the each of the other Parties (which consent may be withheld for any reason or no reason).

13.11 Third Party Beneficiary . Novartis and Penn hereby acknowledge that, pursuant to Section 2.2 of the St. Jude License Agreement, St. Jude is an intended Third Party beneficiary of this Agreement that has the right to directly enforce against Novartis and Penn the terms of this Agreement, subject to the following limitations: St. Jude shall not exercise any of its rights as a Third Party beneficiary granted to it unless: (a) St. Jude has notified Juno in writing of the obligation of Novartis and Penn sought to be enforced (the “ Obligation ”); (b) the Obligation has as its origin a requirement of the St. Jude Agreement; (c) Juno has failed to commence and continue to pursue reasonable steps within [***] after receiving notice from St. Jude pursuant to clause (a) above to enforce the Obligation, or Novartis or Penn has not fulfilled the Obligation within [***] after notice to Juno pursuant to clause (a) above; and (d) at the time St. Jude asserts its rights as a Third Party beneficiary against Novartis and Penn, St. Jude shall have a reasonable basis for believing that Novartis or Penn is in breach of the Obligation sought to be enforced.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

26


Execution Copy

 

13.12 No Patent Marking . Juno acknowledges and agrees that Novartis is not required to mark the Licensed Product(s) sold by Novartis or its Affiliates or its Permitted Sublicensees with the number of the applicable United States granted patent(s) licensed hereunder; provided that Novartis and its Affiliates and Permitted Sublicensees will be obligated to mark Licensed Product(s) with the number of the applicable United States granted patent(s) licensed hereunder if such Licensed Product(s) are marked by other applicable patent(s) not licensed hereunder. To the extent that any Licensed Patent is marked in accordance with this provision, such marking is not an admission that the Licensed Patent is valid and enforceable, or would be infringed by a Licensed Product in the absence of the license provided under this Agreement.

13.13 Compliance with Laws . In all activities undertaken pursuant to this Agreement, Juno and Novartis covenant and agree that each will in all material respects comply with such federal, state and local laws and statutes, as may be in effect at the time of performance and all valid rules, regulations and orders thereof regulating such activities.

13.14 Construction . Each of Novartis, Juno, and Penn have been represented and advised by legal counsel in connection with the negotiation, drafting, and execution of this Agreement, and each of such parties, through their respective counsel, have participated in the drafting of this Agreement and accordingly that this Agreement shall not be deemed to have been drafted by any one of such parties and will be construed accordingly.

13.15 Entire Agreement . This Agreement Including the Settlement Agreement incorporated by reference pursuant to Section 5.01, constitutes and contains the entire understanding and agreement of Novartis, Juno, and Penn with respect to the subject matter hereof and cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether verbal or written, between such parties with respect to subject matter hereof. No waiver, modification, or amendment of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized representative of each of Novartis, Juno, and Penn.

13.16 Counterparts . This Agreement may be executed simultaneously in one or more counterparts (Including in the form of a PDF or other electronic document), each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

(Signature Page Follows)

 

27


IN WITNESS WHEREOF, Juno, Novartis and Penn, have caused this Agreement to be executed by their duly authorized representatives.

JUNO THERAPEUTICS, INC.

 

/s/ Bernard J. Cassidy

Name:  

Bernard J. Cassidy

Title:  

General Counsel & Secretary

Date:  

April 4, 2015

NOVARTIS INSTITUTES OF BIOMEDICAL RESEARCH, INC.

 

/s/ Scott A. Brown

Name:  

Scott A. Brown

Title:  

VP, General Counsel

Date:  

April 3, 2015

THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA

 

/s/ John S. Swartley

Name:  

John S. Swartley, Ph.D.

Title:  

Associate Vice Provost for Research, Executive Director, PCI

Date:  

April 3, 2015

[SIGNATURE PAGE TO NON-EXCLUSIVE SUBLICENSE AGREEMENT]


EXHIBIT 1.14

LICENSED PATENTS

U.S. Patent No.: 8,399,645

[***]

[***]

[***]

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


EXHIBIT 1.28

ST. JUDE AGREEMENT (REDACTED)

(see attachment)


EXCLUSIVE LICENSE AGREEMENT

BETWEEN

ST. JUDE CHILDREN’S RESEARCH HOSPITAL, INC.

&

JUNO THERAPEUTICS, INC.

ST. JUDE File No.: SJ-03-0018


LICENSE AGREEMENT

THIS LICENSE AGREEMENT (the “AGREEMENT”) is entered into as of December 3, 2013 (the “EFFECTIVE DATE”) by and between ST. JUDE CHILDREN’S RESEARCH HOSPITAL, INC., a Tennessee not-for-profit corporation having an address at 262 Danny Thomas Place, Memphis, TN 38105 (“ST. JUDE” or “LICENSOR”), and JUNO THERAPEUTICS, INC., a Delaware corporation, having an address at 8725 W. Higgins Road, Suite 290, Chicago, IL 60631 (“COMPANY”) (ST. JUDE and COMPANY hereinafter each referred to as a “PARTY”, or collectively referred to as the “PARTIES”) with respect to the following:

RECITALS

WHEREAS, as a center for research and education, ST. JUDE is interested in licensing PATENT RIGHTS (hereinafter defined) in a manner that will benefit the public by facilitating the development and distribution of useful products and the utilization of new processes, but is without capacity to commercially develop, manufacture, and distribute any such products or processes; and

WHEREAS, a valuable invention(s) titled “Chimeric Receptors with 4-1BB Stimulatory Signaling Domain” (ST. JUDE File No.: SJ-03-0018) was developed during the course of research conducted by Drs. Dario Campana and Chihaya Imai while employed by ST. JUDE (all hereinafter referred to as “INVENTORS” and each individually referred to as an “INVENTOR”); and

WHEREAS, LICENSOR has acquired through assignment by each of the INVENTORS all rights, title and interest, with the exception of certain retained rights by the United States Government, in their interest in said valuable inventions; and

WHEREAS, COMPANY desires to obtain certain rights in such inventions as herein provided and to commercially develop, manufacture, use and/or distribute products based upon or embodying said valuable inventions throughout the world; and

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

ARTICLE 1

DEFINITIONS

All references to particular Exhibits, Articles or Paragraphs shall mean the Exhibits to, and Paragraphs and Articles of, this AGREEMENT, unless otherwise specified. For the purposes of this AGREEMENT and the Exhibits hereto, the following words and phrases shall have the following meanings:

 

[ ### ] = REDACTED INFORMATION


1.1 “AFFILIATED COMPANY” as used herein in either singular or plural shall mean any corporation, company, partnership, joint venture or other entity, which controls, is controlled by or is under common control with COMPANY. For purposes of this Paragraph 1.1, control shall mean the direct or indirect ownership of at least fifty- percent (50%) of the voting or economic interest in said entity. Any AFFILIATED COMPANY that is exercising rights under this AGREEMENT shall provide a written acknowledgement to LICENSOR that they are bound by, and agree to abide by, the terms of this AGREEMENT.

1.2 “BLA” shall mean a Biologics License Application, as defined in the U.S. Federal Food, Drug, and Cosmetics Act, as amended, and the regulations promulgated thereunder, any alternate market approval application including without limitation a New Drug Application or 510k application, and any corresponding supranational, foreign or domestic equivalent marketing authorization application, registration or certification, necessary to market a LICENSED PRODUCT.

1.3 “EFFECTIVE DATE” of this LICENSE AGREEMENT shall mean the date set forth above.

1.4 “LICENSED FIELD” shall mean all therapeutic, diagnostic, preventative and palliative uses.

1.5 “LICENSED PRODUCT(S)” as used herein in either singular or plural shall mean, on a country by country basis, any material, cell, composition, drug, or other product, the manufacture, use, importation, offer for sale or sale of which would constitute, but for the license granted to COMPANY pursuant to this AGREEMENT, an infringement of a VALID CLAIM of PATENT RIGHTS in that country (infringement shall include, but is not limited to, direct, contributory, or inducement to infringe), assuming, for purposes of determining coverage by this definition, that all pending claims within the PATENT RIGHTS have issued. For the purpose of determining diligence and achievement of clinical development milestones, a product shall fall within this definition even if the exception set forth in 35 U.S.C. § 271(e)(1) may apply.

1.6 “LICENSED SERVICES” shall mean, on a country-by-country basis, any service performed for or on behalf of a third party on a fee-for-service or other basis, the performance of which in the country in question would (without the license granted under the AGREEMENT) infringe at least one VALID CLAIM in that country.

1.7 “NET SALES” shall mean the gross amount billed by COMPANY, AFFILIATES or SUBLICENSEES for LICENSED PRODUCTS or LICENSED SERVICES, less the following:

(a) customary trade, quantity, or cash discounts to the extent actually allowed and taken;

(b) amounts repaid or credited by reason of rejection or return of LICENSED PRODUCTS not replaced or LICENSED SERVICES not re-performed;

 

[ ### ] = REDACTED INFORMATION


(c) to the extent separately stated on purchase orders, invoices, or other documents of sale, any taxes or other governmental charges levied on the production, sale, transportation, delivery, or use of a LICENSED PRODUCT or performance of a LICENSED SERVICE, which is paid by or on behalf of COMPANY or AFFILIATES; and

(d) outbound transportation costs prepaid or allowed and costs of insurance in transit.

No deductions shall be made for [###]. NET SALES shall occur on the date of billing for a LICENSED PRODUCT or LICENSED SERVICE.

Customary distribution of free samples of LICENSED PRODUCT or related performance of LICENSED SERVICES by COMPANY or AFFILIATES that constitute less than [###] of the total annual distribution of LICENSE PRODUCTS and LICENSED SERVICES shall not be included in any calculation of NET SALES.

1.8 “PATENT RIGHTS” shall mean (a) the patent and patent applications listed on Exhibit A hereto, (b) any other patent or patent application that claims priority to, or common priority with, or is a divisional, continuation, reissue, renewal, reexamination, substitution or extension of any patent or patent application identified in (a); (c) any patents subsequently issuing on any patent application identified in (a) or (b), including any reissues, renewals, reexaminations, substitutions or extensions thereof; (d) any claim of a continuation-in-part application or patent (including any reissues, renewals, reexaminations, substitutions or extensions thereof) that is entitled to the priority date of at least one of the patents or patent applications identified in (a), (b) or (c); (e) any foreign counterpart (including PCTs) of any patent or patent application identified in (a), (b), (c) or (d); and (f) any supplementary protection certificates, pediatric exclusivity periods, any other patent term extensions and exclusivity periods and the like of any patents and patent applications identified in (a) through (e). PATENT RIGHTS shall also include any patent applications or patents filed by the Trustees of the University of Pennsylvania (“ Third Party Patent Rights ”) claiming, in whole or part, subject matter disclosed in any of the foregoing patent applications and/or patents to the extent that the inventorship of such Third Party Patent Rights includes, or is corrected to include, one or more of the inventors named in any of the PATENT RIGHTS described in subParagraphs (a)- (f) above. Specifically excluded from PATENT RIGHTS are U.S. Patent Nos. [###] and [###], and any other patent or patent application that claims priority to, or common priority with, or is a divisional, continuation, re-issue, renewal, reexamination, substitution or extension of any patent or patent application identified in clause (a) above that contains only claims directed to the [###].

1.9 “PHASE I CLINICAL TRIAL” shall mean a human clinical trial, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients as required in 21 C.F.R. §312, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States.

1.10 “PHASE II CLINICAL TRIAL” shall mean (i) a human clinical trial, for which a primary endpoint is a preliminary determination of efficacy or dose ranges in patients with the disease target being studied as required in 21 C.F.R. §312.21(b), as may be amended from time to time, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States, or (ii) a combined Phase I and Phase II Clinical Trial which [###], or any Phase III Clinical Trial performed in lieu of a Phase II study.

 

[ ### ] = REDACTED INFORMATION


1.11 “PHASE III CLINICAL TRIAL” shall mean a human clinical trial, the principal purpose of which is to establish safety and efficacy in patients with the disease target being studied as required in 21 C.F.R. §312, or similar clinical study prescribed by the regulatory authorities in a country other than the United States. A Phase III Clinical Trial shall also include any other human clinical trial intended as a pivotal (a Phase II trial that provides evidence for a drug marketing approval) study, whether or not such study is a traditional Phase III study.

1.12 “SUBLICENSE” means any agreement or multiple agreements with a third party which is not an AFFILIATED COMPANY in which COMPANY:

(a) Grants rights in, to or in respect of any of the PATENT RIGHTS;

(b) Grants the right to make, use, offer for sale, sell or import a LICENSED PRODUCT, or to provide a LICENSED SERVICE;

(c) Agrees not to assert the PATENT RIGHTS or agrees not to sue, seek damages or seek injunctive relief for the practice of same;

(d) Assigns or otherwise transfers this AGREEMENT other than as permitted under Article 10.9 herein below and provided that LICENSOR has elected to treat such assignment or transfer as a SUBLICENSE; or

(e) Is under an obligation to do any of the foregoing, or to forbear from offering to do or doing any of the foregoing with any other entity.

The term SUBLICENSE as defined above includes without limitation any agreement that provides a license, option, right of first refusal or negotiation, or covenant not to sue, regarding the PATENT RIGHTS.

1.13 “SUBLICENSEE(S)” as used herein in either singular or plural shall mean any person or entity to which COMPANY has granted a SUBLICENSE.

1.14 “SUBLICENSE CONSIDERATION” shall mean consideration of any kind received by the COMPANY from a SUBLICENSEE(S) for the grant of a SUBLICENSE under or in respect of this AGREEMENT, including, but not limited to, license issue fees, option fees and other licensing fees, milestone payments, minimum annual royalties, license maintenance fees, success fees, and other payments of any kind whatsoever. However, not included in such SUBLICENSE CONSIDERATION are:

(a) [###],

(b) [###],

(c) [###], and

(d) [###].

To the extent that third party rights are sublicensed in combination with the PATENT RIGHTS, the SUBLICENSE CONSIDERATION allocated to the PATENT RIGHTS shall be determined by COMPANY, in consultation with LICENSOR, in good faith with respect to the PATENT RIGHTS and such other rights.

 

[ ### ] = REDACTED INFORMATION


1.15 “ VALID CLAIM ” as used herein in either singular or plural shall mean a claim of any (i) issued and unexpired patent included within the PATENT RIGHTS unless the claim has been held unenforceable or invalid by the final, un-reversed, and un-appealable decision of a court or other government body of competent jurisdiction, has been irretrievably abandoned or disclaimed, or has otherwise been finally admitted or determined to be invalid, unpatentable or unenforceable, whether through reissue, reexamination, disclaimer or otherwise, or (ii) a pending claim of a patent application within the PATENT RIGHTS to the extent the claim continues to be prosecuted in good faith and has not been cancelled, withdrawn, abandoned or finally disallowed without the possibility of appeal or re-filing of such application.

ARTICLE 2

LICENSE GRANT

2.1 Grant. Subject to the terms and conditions of this AGREEMENT, LICENSOR hereby grants to COMPANY (i) an exclusive license to develop, make, have made, use, import, offer for sale, sell, and have sold the LICENSED PRODUCT(S) and LICENSED SERVICES worldwide under the PATENT RIGHTS in the LICENSED FIELD. This license grant shall apply to the COMPANY and any AFFILIATED COMPANY, except that any AFFILIATED COMPANY shall not have the right to sublicense others as set forth in Paragraph 2.2 below. If any AFFILIATED COMPANY exercises rights under this AGREEMENT, such AFFILIATED COMPANY shall be bound by all terms and conditions of this AGREEMENT, including, but not limited to, indemnity and insurance provisions and royalty and other payment provisions, which shall apply to the exercise of the rights, to the same extent as would apply had this AGREEMENT been directly between LICENSOR and the AFFILIATED COMPANY. In addition, COMPANY shall remain fully liable to LICENSOR for all acts, omissions and obligations of AFFILIATED COMPANY such that acts, omissions and obligations of the AFFILIATED COMPANY shall be considered acts, omissions and obligations of the COMPANY. This exclusive license grant is subject to (i) rights retained by the United States Government, if any, in accordance with the Bayh-Dole Act of 1980 (established by P.L. 96-517 and amended by P.L. 98-620, codified at 35 USC § 200 et. seq. and implemented according to 37 CFR Part 401), and (ii) the retained rights of LICENSOR to make, have made and use the inventions claimed in the PATENT RIGHTS for LICENSOR’S internal, non-commercial research purposes. For the avoidance of doubt, LICENSOR shall continue to have the right to distribute its biological materials embodying PATENT RIGHTS for non-profit, academic research use under the material transfer agreements (MTAs) found in Exhibits E and F.

 

[ ### ] = REDACTED INFORMATION


If LICENSOR transfers to a third party any Materials (as defined in the MTAs) covered in whole or part by the PATENT RIGHTS licensed to COMPANY, and is notified by any recipient of any inventions made with the use of such transferred Materials, including without limitation, any patent applications disclosing or claiming any such inventions, LICENSOR shall promptly notify COMPANY, providing any and all information that LICENSOR has regarding such inventions and/or patent applications. At the request of COMPANY, LICENSOR shall negotiate in good faith the terms of a non-exclusive, royalty-bearing worldwide license, with the right to sublicense to COMPANY, with regard to such inventions and/or patent applications to make, have made, use, offer for sale and sell products. LICENSOR shall consult with COMPANY regarding acceptable financial and other terms for any such license and not enter into any agreement with such third party except on terms acceptable to COMPANY. COMPANY shall be responsible for the payment to LICENSOR [###] to the third party for such a license; provided, in no event shall the amount payable to LICENSOR for such a license be more than LICENSOR owes to the third party for any such license. In the event that LICENSOR enters into any such license, the parties shall promptly enter into a written amendment to this AGREEMENT consistent with this paragraph.

2.2 Sublicense. COMPANY may grant SUBLICENSES under the PATENT RIGHTS to third parties pursuant to this AGREEMENT, subject to the terms and conditions of this Paragraph 2.2. COMPANY shall provide LICENSOR with an unredacted copy of each SUBLICENSE between COMPANY and a third party for the grant of rights under the PATENT RIGHTS within thirty (30) days of its execution. Each SUBLICENSE shall: (a) be consistent with the terms, conditions and limitations of this AGREEMENT, (b) name LICENSOR as an intended third party beneficiary of the obligations of SUBLICENSEE without imposition of obligation or liability on the part of LICENSOR or the INVENTORS to the SUBLICENSEE, and (c) [###]. Each SUBLICENSE furnished to LICENSOR by COMPANY shall be the Confidential Information of COMPANY. COMPANY shall (i) be and remain responsible for the performance by such SUBLICENSEE with the terms of this AGREEMENT, and any action by a SUBLICENSEE that would, if conducted by COMPANY be a breach of this AGREEMENT, shall be deemed a breach of this AGREEMENT by COMPANY, and (ii) ascertain, calculate, audit and collect all royalties that become payable by such SUBLICENSEE hereunder and take appropriate enforcement action against such SUBLICENSEE for any failure to pay or to properly calculate payments. LICENSOR shall not exercise any of its rights as a third party beneficiary granted to it pursuant to clause (b) above unless: (w) LICENSOR has notified COMPANY in writing of the obligation of SUBLICENSEE sought to be enforced (the “Obligation”); (x) the Obligation has as its origin a requirement of this AGREEMENT; (y) COMPANY has failed to commence and continue to pursue reasonable steps within thirty (30) days of notice from LICENSOR pursuant to clause (w) above to enforce the Obligation or SUBLICENSEE has not fulfilled the Obligation within ninety (90) days of notice to COMPANY pursuant to clause (w) above, and (z) at the time LICENSOR asserts its rights as a third party beneficiary against SUBLICENSEE, LICENSOR shall have a reasonable basis for believing that SUBLICENSEE is in breach of the Obligation sought to be enforced.

 

[ ### ] = REDACTED INFORMATION


2.3 Government Rights. The United States Government has acquired a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the inventions described in PATENT RIGHTS throughout the world. The rights granted herein are additionally subject to, and expressly conditioned upon compliance with (i) the provisions of the Bayh-Dole Act, 35 USC § 200 et seq, and (ii) other rights acquired, or requirements imposed, by the United States government under the grant/contract award terms and the laws and regulations applicable to the grant/contract award under which the inventions were made.

2.4 Duties of the Parties. LICENSOR is an institute of research and education and not a commercial organization. Therefore, LICENSOR has no ability to evaluate the commercial potential of any PATENT RIGHTS, LICENSED PRODUCT or LICENSED SERVICES or other license or rights granted in this AGREEMENT. It is therefore incumbent upon COMPANY to evaluate the rights, products and services in question, to examine the materials and information provided by LICENSOR and to determine for itself the validity of any PATENT RIGHTS, its freedom to operate, and the value of any LICENSED PRODUCTS or LICENSED SERVICES or other rights granted.

ARTICLE 3

FEES, ROYALTIES, & PAYMENTS

3.1 License Fee. COMPANY shall pay to LICENSOR within [###] of the EFFECTIVE DATE a license fee as set forth in Exhibit B . LICENSOR will not submit an invoice for the license fee, which is nonrefundable and shall not be credited against royalties or other fees. Time is of the essence with respect to payment of this fee. This AGREEMENT shall be null and void ab initio if the License Fee is not received within [###] of the EFFECTIVE DATE.

3.2 Minimum Annual Royalties. COMPANY shall pay to LICENSOR minimum annual royalties as set forth in Exhibit B . These minimum annual royalties shall be due [###] on January 1 following each anniversary of the EFFECTIVE DATE beginning with the first anniversary, and shall be payable within [###] thereafter. For clarity, the first minimum annual royalty payment, for the calendar year 2014, shall be due on January 1, 2015, and payable no later than [###]. Running royalties accrued under Paragraph 3.3 and paid to LICENSOR for a given calendar year shall be credited against the minimum annual royalties due for such calendar year. For example, running royalties accrued under and paid to LICENSOR during calendar year 2015 shall be credited only against the minimum annual royalty payment due and payable no later than [###].

3.3 Running Royalties. COMPANY shall pay to LICENSOR a running royalty as set forth in Exhibit B , for LICENSED PRODUCT(S) and LICENSED SERVICE sold by COMPANY, AFFILIATED COMPANIES and/or SUBLICENSEE(S), based on NET SALES for the Term of this AGREEMENT. Such payments shall be due semi-annually (June 30 th and December 31 st ) and shall be payable within [###] of the end of each half year. Such royalties shall [###] based on [###] related to LICENSED PRODUCTS and LICENSED SERVICES.

 

[ ### ] = REDACTED INFORMATION


Notwithstanding anything to the contrary in this AGREEMENT, in order to insure LICENSOR the full royalty and other payments contemplated hereunder, COMPANY agrees that in the event any LICENSED PRODUCT(S) or LICENSED SERVICES shall be sold to a corporation, firm or association (the “PURCHASER”) with which COMPANY shall have any agreement, understanding or arrangement with respect to consideration (such as, among other things, an option to purchase stock or actual stock ownership, or an arrangement involving division of profits or special rebates or allowances) received by COMPANY with respect to sale of such LICENSED PRODUCT(S) or LICENSED SERVICES, the royalties to be paid hereunder to LICENSOR for such LICENSED PRODUCT(S) or LICENSED SERVICES shall be based upon the greater of: 1) the [###] of the LICENSED PRODUCT(S) or LICENSED SERVICES as of the date that COMPANY receives such consideration from such PURCHASER, or 2) the [###] of LICENSED PRODUCT(S) or LICENSED SERVICES paid by the PURCHASER.

3.4 SUBLICENSE CONSIDERATION. In addition to the running royalty as set forth under Paragraph 3.3, COMPANY shall pay to LICENSOR, as set forth on Exhibit B a percentage of SUBLICENSE CONSIDERATION. Any SUBLICENSE CONSIDERATION payment due to LICENSOR shall be due within [###] of the end of the six (6) month calendar period in which any SUBLICENSE CONSIDERATION was received, [###]. Such payment shall be accompanied by a detailed written report setting forth the nature and scope of the rights granted, and the total consideration received. COMPANY shall not directly or indirectly accept [###].

3.5 Milestone Payments. COMPANY shall pay to LICENSOR the milestone payments as set forth in Exhibit C for the term of this AGREEMENT. For the avoidance of doubt, clinical trials of LICENSED PRODUCT conducted by COMPANY or on its behalf by other entities with respect to which COMPANY owns or has the right to use the data resulting therefrom and has an obligation to report such results to the regulatory authority having jurisdiction over the conduct of human clinical trials and the approval of products for human use in the jurisdiction where such clinical trials are conducted, including ongoing clinical trials at Fred Hutchinson Cancer Research Center sponsored by COMPANY, shall be considered for determining achievement of milestones. All non-US taxes (excluding any taxes based on LICENSOR’S income) related to milestone payments shall be paid by COMPANY and shall not be deducted from payments due to LICENSOR.

3.6 Patent Prosecution Reimbursement. COMPANY will reimburse LICENSOR, within thirty (30) days of the EFFECTIVE DATE the amount of [###] for costs associated with the preparation, filing, maintenance, and prosecution of PATENT RIGHTS incurred by LICENSOR on or before the EFFECTIVE DATE. In accordance with Paragraph 4.1 below, COMPANY will reimburse LICENSOR, within [###] of the receipt of an invoice from LICENSOR, for all reasonable costs associated with the preparation, filing, maintenance, and prosecution of PATENT RIGHTS in the LICENSED FIELD incurred by LICENSOR subsequent to the EFFECTIVE DATE.

3.7 Form of Payment. All payments under this AGREEMENT shall be made in U.S. Dollars. Checks are to be made payable to “St. Jude Children’s Research Hospital”. Wire transfers may be made using the following information:

 

[ ### ] = REDACTED INFORMATION


Acct Name: St. Jude Children’s Research Hospital, Master Concentration Account

Acct Number: [###]

Bank Name: First Tennessee Bank

Bank Swift: FTNMUS44

Bank ABA #: 084-000026

Bank Address: Post Office Box 84

Memphis, TN 38101

USA

COMPANY shall be responsible for any and all costs associated with wire transfers and shall include a reference to this AGREEMENT in any wire transfer payment. Payments made by check should be sent to the following address:

St. Jude Children’s Research Hospital

P.O. Box 1000, Department # 516

Memphis, TN 38148-0516

3.8 Late Payments. In the event that any payment due hereunder is not made when payable, the payment shall accrue interest beginning on the tenth day following the due date thereof, calculated at the rate of [###] per month from the date said payment is due, provided however, that in no event shall said annual interest rate exceed the maximum legal interest rate for corporations. Each such payment when made shall be accompanied by all interest so accrued. Said interest and the payment and acceptance thereof shall not negate or waive the right of LICENSOR to seek any other remedy, legal or equitable, to which it may be entitled because of the delinquency of any payment including, but not limited to termination of this AGREEMENT as set forth in Article 9.

3.9 Withholding Taxes. Notwithstanding that LICENSOR is a tax-exempt entity under the United States Internal Revenue Code, as amended, in the event that payments due to LICENSOR in respect of NET SALES in jurisdictions other than the United States are subject to required withholding, such taxes shall be deducted by COMPANY (or its SUBLICENSEES) from such payment prior to remittance, and shall be paid over to the relevant taxing authorities when due. COMPANY shall promptly furnish LICENSOR evidence of any such taxes withheld and of payment thereof, and shall render reasonable assistance to LICENSOR in connection with its invocation of available procedures to seek refund of such payments.

ARTICLE 4

PATENT PROSECUTION, MAINTENANCE, & INFRINGEMENT

4.1 Prosecution & Maintenance. LICENSOR [###] shall be the PARTY responsible for the filing, prosecution and maintenance of patents and patent applications specified under PATENT RIGHTS and, subject to the terms and conditions of this AGREEMENT, COMPANY shall be licensed thereunder. Title to all such patents and patent applications shall reside in LICENSOR. LICENSOR shall have full and complete control over all patent matters in connection therewith under the PATENT RIGHTS, provided however, that LICENSOR shall

 

[ ### ] = REDACTED INFORMATION


(a) cause its patent counsel, reasonably acceptable to COMPANY, to timely copy COMPANY on all official actions and written correspondence with any patent office, and (b) allow COMPANY and/or counsel appointed by COMPANY an opportunity and reasonably sufficient time to comment and advise LICENSOR with respect thereto. The exercise of such right by COMPANY shall not interfere with the timely filing or submission of any document with, or response to, any official patent office. LICENSOR shall consider in good faith and reasonably incorporate all comments and advice from COMPANY, to the extent that they would tend to cover in more specificity, support or expand the scope of rights sought. By concurrent written notification to LICENSOR and its patent counsel at least [###] in advance of any filing or response deadline, or fee due date, COMPANY may elect not to have a patent application filed in any particular country or not to pay expenses associated with prosecuting or maintaining any patent application or patent within PATENT RIGHTS, provided that COMPANY pays for [###] incurred up to LICENSOR’S receipt of such notification. Failure to provide such notification can be considered by LICENSOR to be COMPANY’s authorization to proceed [###]. Upon such notification, at LICENSOR’S own expense, LICENSOR may file, prosecute, and/or maintain such patent applications or patent within the PATENT RIGHTS with respect to which COMPANY has made the foregoing decision(s) (collectively, the “COMPANY-DECLINED PATENTS”), and any rights or license granted hereunder held by COMPANY, AFFILIATED COMPANIES or SUBLICENSEE(S) relating to COMPANY-DECLINED PATENTS shall terminate.

4.2 Notification. Each PARTY will notify the other promptly in writing when any infringement by a third party is uncovered or suspected.

4.3 Infringement.

a. General. Except as is set forth in Paragraph 4.3b, COMPANY shall have the first right to conduct and control, [###], all patent litigation relating to the PATENT RIGHTS during the Term, including the first right to enforce any patent within PATENT RIGHTS against any infringement or alleged infringement thereof, and shall at all times keep LICENSOR informed as to the status of all such litigation. Before COMPANY may commence an action with respect to any infringement of the PATENT RIGHTS, it must obtain the consent of LICENSOR, such consent not to be unreasonably withheld. Thereafter, COMPANY may, in its sole discretion and at its own expense, may institute suit against any such infringer or alleged infringer and control and defend such suit in a manner consistent with the terms and provisions hereof and recover any damages, awards or settlements resulting therefrom, to be shared by COMPANY and LICENSOR in the manner set forth below. However, no settlement, consent judgment or other voluntary final disposition of the suit may be entered into without the prior written consent of LICENSOR. LICENSOR shall not unreasonably withhold consent of any settlement, consent judgment or other voluntary final disposition of suit that does not admit the invalidity of any patent within PATENT RIGHTS and which does not purport to admit any fault or wrongdoing on the part of LICENSOR. LICENSOR shall reasonably cooperate in any such litigation, [###] including by joining as a party if required by applicable law.

 

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If COMPANY elects not to enforce any patent within the PATENT RIGHTS, then it shall so notify LICENSOR in writing within [###] of receiving notice that an infringement or suspected infringement exists. LICENSOR may, in its sole judgment and at its own expense, take steps to enforce any patent and commence, control, settle, and defend any such suit in a manner consistent with the terms and provisions hereof, and recover any damages, awards or settlements resulting therefrom, to be shared by COMPANY and LICENSOR in the manner set forth below. At LICENSOR’s request, COMPANY shall reasonably cooperate with any such litigation, at LICENSOR’s expense.

b. [###]

c. Prospective Patent Litigation. With respect to any litigation controlled by COMPANY pursuant to Paragraph 4.3a, COMPANY shall at all times keep LICENSOR informed as to the status thereof and shall (a) cause its litigation counsel, which counsel shall be reasonably acceptable to LICENSOR, to timely copy LICENSOR on all official actions and written correspondence, and (b) allow LICENSOR and counsel appointed by LICENSOR an opportunity and reasonably sufficient time to comment and advise COMPANY with respect thereto, [###]; provided that [###] must be reasonable and reflect that COMPANY is controlling the conduct of such litigation. COMPANY, in responding to the comments and advice of LICENSOR, shall give careful consideration to the views of LICENSOR and to potential effects on LICENSOR’S interests under this AGREEMENT and to potential effects on the public interest in any such action. However, no settlement, consent judgment or other voluntary final disposition of the suit may be entered into without the prior written consent of LICENSOR. LICENSOR shall not unreasonably withhold consent of any settlement, consent judgment or other voluntary final disposition of suit that does not admit the invalidity of any patent within PATENT RIGHTS and which does not purport to admit any fault or wrongdoing on the part of LICENSOR. LICENSOR shall cooperate fully with COMPANY in connection with any litigation related to PATENT RIGHTS, [###]. Any recovery obtained as a result of such litigation shall (i) first, go to reimburse the PARTY controlling the litigation for its out of pocket costs in connection with such litigation; (ii) second, from any damages awarded other than for willful infringement, LICENSOR shall receive the equivalent of [###] based on the [###] or [###] (i.e., an amount equal to [###]), and (iii) any damages awarded for willful infringement shall go [###] percent ([###]%) to the PARTY controlling the litigation and [###] percent ([###]%) shall go to the other PARTY.

ARTICLE 5

OBLIGATIONS OF THE PARTIES

5.1 Reports. COMPANY shall provide to LICENSOR the following written reports, which reports shall be Confidential Information of COMPANY, according to the following schedules.

(a) COMPANY shall provide semi-annual royalty reports, substantially in the format of Exhibit D , or as may be otherwise agreed by the parties in writing and due within [###] of the end of each calendar half year following the first commercial sale of a LICENSED PRODUCT. Royalty Reports shall disclose the amount of [###]. Payment of any such royalties due shall accompany such Royalty Reports.

 

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(b) Until such time as COMPANY, an AFFILIATED COMPANY or a SUBLICENSEE(S) has achieved a first commercial sale of a LICENSED PRODUCT, or received FDA market approval, COMPANY shall provide annual diligence reports, due within [###] of the end of every December following the EFFECTIVE DATE of this AGREEMENT. These diligence reports shall describe COMPANY’s, AFFILIATED COMPANY’s or any SUBLICENSEE(S)’s technical and other efforts towards meeting its obligations under the terms of this AGREEMENT, particularly its progress toward achieving the developmental milestones set forth in Exhibit C and shall explain any delays experienced in achieving such milestones relative to the projected dates for achievement set forth in Exhibit C .

(c) COMPANY shall further provide in conjunction with the reports due pursuant to Paragraphs 5.1(a) and 5.1(b), the following information:

[###]

5.2 Records. COMPANY shall make and retain, for a period of [###] following the period of each report required by Paragraph 5.1(a), true, complete and accurate records, files and books of account containing all the data reasonably required for the full computation and verification of sales and other information required in Paragraph 5.1(a). Such books and records shall be in accordance with generally accepted accounting principles consistently applied. COMPANY shall permit the inspection of such records, files and books of account by LICENSOR’S agent (the “Auditor”), which Auditor shall be a nationally recognized auditor acceptable to COMPANY, such acceptance not to be unreasonably withheld, and subject to obligations of confidentiality and nonuse owed to LICENSOR consistent with the confidentiality and non-use obligations set forth in this Agreement. Any such inspection shall occur during regular business hours upon [###] written notice to COMPANY. Such inspection shall not be made more than once each calendar year. All costs of such inspection shall be paid by LICENSOR, provided that if any such inspection shall reveal that an error or omission has been made resulting in an underpayment equal to [###], the costs of such inspection shall be borne by COMPANY. As a condition to entering into any agreement, COMPANY shall include in any agreement with its AFFILIATED COMPANIES or its SUBLICENSEE(S) which permits such party to make, use, offer to sell, sell or import the LICENSED PRODUCT(S) or LICENSED SERVICES, a provision requiring such party to retain records of sales of LICENSED PRODUCT(S) or LICENSED SERVICES and other information as required in Paragraphs 5.1(a) and this Paragraph 5.2 and permit the Auditor to inspect such records as required by this Paragraph 5.2. All information and records made available to the Auditor pursuant to this Paragraph 5.2 shall be deemed to be and treated as Confidential Information of COMPANY pursuant to Article 8.

5.3 Commercially Reasonable Efforts. COMPANY shall exercise commercially reasonable efforts to develop and to introduce the LICENSED PRODUCT(S) and/or LICENSED SERVICES into the commercial market as soon as practicable, consistent with sound and reasonable business practice and judgment; thereafter, until the expiration or termination of this AGREEMENT, COMPANY shall endeavor to keep LICENSED PRODUCT(S) and LICENSED SERVICES reasonably available to the public. COMPANY shall also exercise commercially reasonable efforts to develop LICENSED PRODUCT(S) suitable for different indications within the LICENSED FIELD, so that the PATENT RIGHTS can be commercialized as broadly and as speedily as good scientific, clinical and business judgment would deem possible. Development Milestones for the LICENSED PRODUCTS are detailed in Exhibit C .

 

[ ### ] = REDACTED INFORMATION


COMPANY shall notify LICENSOR well in advance if COMPANY believes that it will fail to achieve the Development Milestones in the expected timeframe as detailed in Exhibit C despite its exercise of commercially reasonable and diligent efforts.

If COMPANY fails to achieve any of the Development Milestones described in Exhibit C within the timeframes specified due to causes that are beyond the reasonable control of COMPANY, (e.g., regulatory action or delay, low patient enrollment, in each case, provided that the COMPANY has conducted the relevant activities in a reasonable manner), notwithstanding COMPANY’ s reasonable, good faith efforts to achieve those milestones, then COMPANY will not be deemed in default or breach of this AGREEMENT and the timeframe for achieving those milestones will be deemed automatically extended by the time of the delay reasonably attributable to the causes that were beyond COMPANY’s control as long as COMPANY diligently and continuously pursues the achievement of such milestones. A failure on the part of COMPANY [###] to pursue timely achievement of the Development Milestones shall be deemed to be a failure within the control of COMPANY.

In the event that the foregoing paragraph does not apply, if the COMPANY fails to reach any milestone in Exhibit D for which a payment is required, then COMPANY may extend that milestone completion date and all subsequent milestone completion dates for a period of [###] (each a “Delayed Milestone”). In order to be entitled to that extension, COMPANY shall, within [###] after the applicable deadline for the achievement of the applicable milestone (i) pay to LICENSOR [###] of the Milestone Payment that would otherwise have been due had COMPANY timely achieved the applicable Milestone and (ii) [###]. If COMPANY fails to reach any Delayed Milestone, then COMPANY may obtain a further [###] month extension. In order to be entitled to the second extension, COMPANY shall, within [###] after the deadline for the achievement of the unachieved Delayed Milestone (a) pay to LICENSOR [###] of the Milestone Payment that would otherwise have been due had COMPANY timely achieved the Delayed Milestone, and (b) [###]. Total delays granted under this provision shall not exceed [###] months. Notwithstanding the above, with regard to milestone 1(g) on Exhibit C ([###]), in the event that COMPANY fails to timely achieve this milestone and seeks one or more extensions under this paragraph the payment due for any such extension shall be $[###].

Subject to the terms of this Paragraph 5.3, failure by COMPANY or its SUBLICENSEES to achieve the Development Milestones within the extended timeframe or to diligently and continuously purse the achievement of the Milestones shall be a breach of Paragraph 5.3, and may result in the [###]. In the event COMPANY ceases all activities directed at the development and commercialization of LICENSED PRODUCT(S) and LICENSED SERVICES, the rights granted to COMPANY under this AGREEMENT shall terminate immediately without further action of either PARTY.

 

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5.4 Obligations. In the event that LICENSOR determines that COMPANY, AFFILIATED COMPANIES or SUBLICENSEES, have not fulfilled their obligations under Paragraph 5.3, LICENSOR shall furnish COMPANY with written notice of such determination at which time the provisions of Paragraph 5.3 shall apply.

5.5 Patent Acknowledgement. COMPANY agrees that all packaging containing individual LICENSED PRODUCT(S) sold by COMPANY, AFFILIATED COMPANIES and SUBLICENSEE(S) will be marked with the number of the applicable patent(s) licensed hereunder in accordance with each country’s patent laws, and that patent marking requirements will otherwise be complied with.

5.6 Patent Term Extensions. COMPANY and LICENSOR agree that LICENSOR may, in its sole discretion, elect to extend the term of any patents within the PATENT RIGHTS will be extended by all means provided by law or regulation, including without limitation extensions provided under U.S. law at 35 U.S.C. §§154(b) and 156. COMPANY hereby agrees to provide LICENSOR with all necessary assistance in securing such extensions, including without limitation, providing all information regarding applications for regulatory approval, approvals granted, and the timing of same.

5.7 Challenge to Validity/Enforceability of PATENT RIGHTS by COMPANY. If COMPANY challenges the validity or enforceability of PATENT RIGHTS maintain this AGREEMENT in force during such challenge, and LICENSOR in its sole discretion determines not to terminate the AGREEMENT, then COMPANY shall reimburse LICENSOR for any and all costs incurred in defense of such proceedings, including without limitation attorney’s fees, expert witness fees and court costs, within [###] of each invoice for same submitted to COMPANY by LICENSOR or LICENSOR’s counsel. Failure to timely reimburse such costs will constitute a material breach of this AGREEMENT. In addition, any payments required hereunder must be timely made in full when due, in cash and readily available funds; and once paid, no such amounts will be subject to replevin, refund or recovery by COMPANY or AFFILIATED COMPANIES or SUBLICENSEES, irrespective of whether such challenge was successful.

ARTICLE 6

REPRESENTATIONS

6.1 Representations by LICENSOR. Except for (i) the rights of the Government of the United States of America and (ii) in connection with the transfer of biological materials for academic research purposes, LICENSOR represents and warrants that: (a) the execution, delivery and performance of this AGREEMENT have been duly authorized by all necessary corporate action on the part of LICENSOR, (b) it is the owner of the entire right, title, and interest in and to the PATENT RIGHTS, (c) it has the sole right to grant licenses thereunder, (d) it has not granted licenses thereunder or liens, encumbrances, security interests or restrictions to any other entity that would conflict with the rights granted hereunder except as stated herein, and (e)  Exhibit A contains a complete list of all current patent applications and patents owned (in whole and in part) by LICENSOR as of the EFFECTIVE DATE relating to [###]. LICENSOR covenants that it will not grant during the term of this AGREEMENT any right, license or interest in the PATENT RIGHTS,

 

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or any portion thereof, inconsistent with the license granted to COMPANY herein. LICENSOR does not warrant the validity of any patents within the PATENT RIGHTS or that practice under such patents shall be free of infringement of third party intellectual property rights, and COMPANY assumes all responsibility and liability for any such infringement. EXCEPT AS EXPRESSLY SET FORTH IN THIS PARAGRAPH 6.1, COMPANY AND AFFILIATED COMPANIES AGREE THAT THE PATENT RIGHTS ARE PROVIDED “AS IS”, AND THAT LICENSOR MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO THE PERFORMANCE OF LICENSED PRODUCT(S) OR LICENSED SERVICES INCLUDING THEIR SAFETY, EFFECTIVENESS, OR COMMERCIAL VIABILITY. LICENSOR DISCLAIMS ALL WARRANTIES WITH REGARD TO PRODUCT(S) AND SERVICES LICENSED UNDER THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ALL WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE. NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, LICENSOR ADDITIONALLY DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON THE PART OF LICENSOR AND INVENTORS, FOR DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL, AND CONSEQUENTIAL DAMAGES, ATTORNEYS’ AND EXPERTS’ FEES, AND COURT COSTS (EVEN IF LICENSORS HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE, IMPORTATION, OFFER FOR SALE OR SALE OF THE PRODUCT(S) AND SERVICES LICENSED UNDER THIS AGREEMENT. COMPANY, AFFILIATED COMPANIES AND SUBLICENSEE(S) ASSUME ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A PRODUCT OR SERVICE MANUFACTURED, USED, OR SOLD BY COMPANY, ITS SUBLICENSEE(S) AND AFFILIATED COMPANIES WHICH IS A LICENSED PRODUCT(S) OR LICENSED SERVICE AS DEFINED IN THIS AGREEMENT.

6.2 Representations by COMPANY. COMPANY represents and warrants that: (a) It is a corporation duly organized and validly existing under the laws of its jurisdiction of incorporation and has all requisite corporate power and authority to enter into this AGREEMENT, (b) it is duly authorized by all requisite action to execute, deliver and perform this AGREEMENT and to consummate the transactions contemplated hereby, and that the same do not conflict or cause a default with respect to its obligations under any other agreement and (c) it has duly executed and delivered this AGREEMENT.

ARTICLE 7

INDEMNIFICATION

7.1 Indemnification. COMPANY hereby agrees to, and shall, indemnify, defend, with counsel reasonably acceptable to LICENSOR, and hold LICENSOR, the American Lebanese Syrian Associated Charities, Inc. (ALSAC; a non-profit, 501(c)(3) corporation which supports LICENSOR), their present and former trustees, directors, governors, officers, INVENTORS of PATENT RIGHTS, agents, faculty, employees and students harmless as against any claims, demands, damages consequential, judgments, fees (including reasonable attorneys’ fees), expenses, or other costs arising from or incidental to a breach of any representation, warranty or

 

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covenant made by COMPANY in this AGREEMENT, any product liability, intellectual property infringement or other lawsuit, claim, demand or other action brought by a third party as [###], whether or not LICENSORS or said INVENTORS, either jointly or severally, are named as a party defendant in any such lawsuit and whether or not LICENSOR or the INVENTORS are alleged to be negligent or otherwise responsible for any injuries to persons or property. [###]. The obligation of COMPANY to defend, indemnify and hold harmless as set out in this Paragraph shall survive the termination of this AGREEMENT, shall continue even after grant, license or assignment of rights and responsibilities to an AFFILIATED COMPANY or SUBLICENSEE, and shall include the obligation to indemnify against any damages awarded a third party, including consequential or indirect damages. COMPANY shall require any AFFILIATED COMPANY practicing the PATENT RIGHTS and any SUBLICENSEE to agree to indemnification provisions in favor of LICENSOR substantially similar to the above.

ARTICLE 8

CONFIDENTIALITY

8.1 Confidentiality. If necessary, the Parties will exchange information they consider to be confidential, including but not limited to the terms of this AGREEMENT and any reports or information provided by COMPANY pursuant to Article 5 (“Confidential Information”). The recipient of such information agrees to accept the disclosure of said information. The recipient of Confidential Information agrees to employ all reasonable efforts to maintain the Confidential Information secret and confidential, such efforts to be no less than the degree of care employed by the recipient to preserve and safeguard its own confidential information. The Confidential Information shall not be disclosed or revealed to anyone except officers, directors, employees and contractors of the recipient who (i) have a need to know the Confidential Information, (ii) are subject to obligations of confidentiality and non-use substantially similar to those set forth in this Article 8, and (iii) have been advised by the recipient of the confidential nature of the Confidential Information and that the Confidential Information shall be treated accordingly.

The obligations of this Paragraph shall also apply to AFFILIATED COMPANIES and/or SUBLICENSEE(S) that are provided such Confidential Information by COMPANY. LICENSOR’S, COMPANY’s, AFFILIATED COMPANIES’, and SUBLICENSEES’ obligations under this Paragraph shall extend until [###] of this AGREEMENT.

8.2 Exceptions. The recipient’s obligations under Paragraph 8.1 shall not extend to any part of the Confidential Information:

 

  a. that can be demonstrated to have been in the public domain or publicly known and readily available to the trade or the public prior to the date of the disclosure; or

 

  b. that can be demonstrated, from written records to have been in the recipient PARTY’ s possession or readily available to the recipient PARTY from another source not under obligation of secrecy to the disclosing PARTY prior to the disclosure; or

 

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  c. that becomes part of the public domain or publicly known by publication or otherwise, not due to any unauthorized act by the recipient PARTY; or

 

  d. that is demonstrated from written records to have been developed by or for the receiving PARTY without reference to Confidential Information disclosed by the disclosing PARTY.

 

  e. that is required to be disclosed by law, government regulation or court order.

8.3 Right to Publish. LICENSOR may publish manuscripts, abstracts or the like describing the PATENT RIGHTS and inventions contained therein provided no Confidential Information of COMPANY as defined in Paragraph 8.1, is included or LICENSOR first obtains written approval from COMPANY to include such Confidential Information in any such public disclosure. Otherwise, LICENSOR and the INVENTORS shall be free to publish manuscripts and abstracts or the like without prior approval. The text of the proposed manuscripts, abstracts or the like containing any COMPANY Confidential Information must be provided to COMPANY at least [###] prior to the date of submission for consideration for manuscripts, abstracts or the like in order to provide COMPANY an opportunity to comment on such proposed manuscripts, abstracts or the like and determine if COMPANY Confidential Information is disclosed therein. In the event that COMPANY so comments prior to such intended submission date, LICENSOR shall delay submission of such manuscripts, abstracts or the like [###] beyond such intended submission date and, during such [###] period, engage in good faith discussion of such comments with COMPANY, and consider in good faith the modification of such proposed manuscripts, abstracts or the like pursuant to such comments, but LICENSOR will have no obligation to accept or make such modifications. Upon the request of COMPANY, LICENSOR shall remove any COMPANY Confidential Information from any proposed manuscripts, abstracts or the like.

ARTICLE 9

TERM & TERMINATION

9.1 Term. The term of this AGREEMENT shall commence on the EFFECTIVE DATE and shall continue, in each country, until the date of expiration of the last to expire VALID CLAIM included within PATENT RIGHTS in that country.

9.2 Termination by Either PARTY. This AGREEMENT may be terminated by either COMPANY or LICENSOR, in the event that the other PARTY (a) to the extent permissible under applicable and prevailing law, files or has filed against it a petition under the Bankruptcy Act, makes an assignment for the benefit of creditors, has a receiver appointed for it or a substantial part of its assets, or otherwise takes advantage of any statute or law designed for relief of debtors or (b) fails to perform or otherwise breaches any of its obligations hereunder, if, following the giving of notice by the terminating PARTY of its intent to terminate and stating the grounds therefor, the PARTY receiving such notice shall not have cured such failure or breach within sixty (60) days. In no event, however, shall such notice or intention to terminate be deemed to waive any rights to damages or any other remedy which the PARTY giving notice of breach may have as a consequence of such failure or breach.

 

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9.3 Termination by COMPANY. COMPANY may terminate this AGREEMENT and the license granted herein as to any patent application or patent within the PATENT RIGHTS, for any reason, upon giving LICENSOR [###] written notice.

9.4 Termination by LICENSOR. Except as may be otherwise expressly set forth in this AGREEMENT, in the event COMPANY breaches or defaults in the performance of its obligations under this AGREEMENT, LICENSOR may terminate this AGREEMENT and the licenses granted herein upon [###] written notice, subject to cure thereof by COMPANY in accordance with Paragraphs 5.3 and 5.4.

9.5 Obligations and Duties upon Termination. If this AGREEMENT is terminated, the PARTIES shall be released from all obligations and duties imposed or assumed hereunder to the extent so terminated, except as expressly provided to the contrary in this AGREEMENT. Upon termination subject to Paragraph 9.6, each PARTY shall cease any further use of the Confidential Information received from the other PARTY. Termination of this AGREEMENT, for whatever reason, shall not affect the obligation of any PARTY to make any payments for which it is liable prior to or upon such termination. Termination shall not affect LICENSOR’S right to recover unpaid royalties, fees, reimbursement for patent expenses, or other forms of financial compensation owed prior to termination. Upon termination, COMPANY shall submit a final royalty report to LICENSOR and any royalty payments (if after first commercial sale of LICENSED PRODUCTS), fees, unreimbursed patent expenses and other financial compensation due to LICENSOR shall become immediately payable. Furthermore, upon termination of this AGREEMENT, all rights in and to the PATENT RIGHTS shall revert immediately to LICENSOR at no cost to LICENSOR. Upon any termination of this AGREEMENT, any SUBLICENSEE(S) shall become, with such SUBLICENSEE(S)’ agreement, a direct licensee of LICENSOR, provided that (a) such SUBLICENSEE(S) cure any default of the COMPANY of which they are legally capable, including in all events paying all amounts due under this AGREEMENT, (b) such SUBLICENSEE(S) was not the cause of terminations, and (c) LICENSOR’S obligations to SUBLICENSEE(S) are no greater than LICENSOR’S obligations to COMPANY under this AGREEMENT and the SUBLICENSEE’S obligations to LICENSOR are no greater than the obligations of COMPANY to LICENSOR under this AGREEMENT. COMPANY shall provide written notice of such to each SUBLICENSEE(S) with a copy of such notice provided to LICENSOR.

9.6 COMPANY may, within [###] of the effective date of any termination of this AGREEMENT, sell all LICENSED PRODUCTS and parts therefor that it has on hand at the date of termination, if COMPANY pays to LICENSOR the earned royalty thereon.

ARTICLE 10

MISCELLANEOUS

10.1 Use of Name or Logo. Neither LICENSOR nor COMPANY shall use the name, image or logo of the other PARTY, or the name of an affiliate, a current of former staff member, employee, student or affiliated physician or faculty of the other PARTY, or any adaptation thereof, in any advertising, promotional or sales literature without the prior written approval of the PARTY.

 

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10.2 Notification of Promotion and Acknowledgment of Contributions. COMPANY shall notify the LICENSOR in writing at least [###] in advance of any press release or promotional communication related to LICENSED PRODUCTS or LICENSED SERVICES or from any innovations that are a downstream result of research involving the LICENSED PRODUCTS or LICENSED SERVICES to determine whether the LICENSOR wishes to be acknowledged. Promotional communications include online content, brochures, advertising or public presentations. For any such release or promotion, COMPANY shall include, at the LICENSOR’S discretion, [###].

10.3 No Partnership. Nothing in this AGREEMENT shall be construed to create any agency, employment, partnership, joint venture or similar relationship between LICENSOR and COMPANY other than that of a licensor/licensee. Neither LICENSOR nor COMPANY shall have any right or authority whatsoever to incur any liability or obligation (express or implied) or otherwise act in any manner in the name or on the behalf of the other, or to make any promise, warranty or representation binding on the other.

10.4 Notice of Claim. Each, LICENSOR and COMPANY, shall give the other or its representative immediate notice of any suit or action filed, or prompt notice of any claim made, against them arising out of the performance of this AGREEMENT or arising out of the practice of the inventions licensed hereunder.

10.5 Insurance. Prior to initial human testing or FIRST COMMERCIAL SALE of any LICENSED PRODUCT(S) or LICENSED SERVICES as the case may be and thereafter until [###], COMPANY and SUBLICENSEES shall establish and maintain insurance coverage in such country in the minimum amount of [###], to cover any liability arising from COMPANY’S indemnification obligations under Article 7 above with respect to such human testing or commercial sale of LICENSED PRODUCT(S) or LICENSED SERVICE, and prior to the expiration of such period shall obtain tail coverage for the same limits. Prior to initial human testing or FIRST COMMERCIAL SALE of any LICENSED PRODUCT(S) as the case may be and thereafter until [###], COMPANY and SUBLICENSEES shall establish and maintain, in each country in which COMPANY, an AFFILIATED COMPANY or SUBLICENSEE(S) shall test or sell LICENSED PRODUCT(S), product liability or other appropriate insurance coverage in the minimum amount of [###], and prior to the expiration of such period shall obtain tail coverage for the same limits. COMPANY will annually present evidence, in the form of a statement in the annual report to LICENSOR that such coverage is being maintained. Upon LICENSOR’S request, COMPANY will furnish LICENSOR with a Certificate of Insurance of each insurance policy obtained. LICENSOR and ALSAC shall be listed as additional insureds in COMPANY’s, AFFILIATED COMPANIES’ and SUBLICENSEES’ said insurance policies. If such insurance is underwritten on a ‘claims made’ basis, COMPANY agrees that any change in underwriters during the term of this AGREEMENT and thereafter so long as LICENSED PRODUCTS are being sold will require the purchase of ‘prior acts’ coverage to ensure that coverage will be continuous throughout the Term of this AGREEMENT and thereafter until [###] following expiration dating of the last batch of LICENSED PRODUCT manufactured. All such insurance shall be primary and non-contributory. All such insurers shall have a minimum financial rating by A.M Best of [###].

 

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10.6 Governing Law and Venue. Any legal action arising from this AGREEMENT shall be brought in Memphis, Tennessee and shall be governed by the law of the State of Tennessee, without regard to the conflicts of laws provisions thereof.

10.7 Notice. All notices or communication required or permitted to be given by either PARTY hereunder shall be deemed sufficiently given if mailed by registered mail or certified mail, return receipt requested, or sent by overnight courier, such as Federal Express, to the other PARTY at its respective address set forth below or to such other address as one PARTY shall give notice of to the others from time to time hereunder or if sent by facsimile to the other PARTY at its respective facsimile number provided below and receipt is acknowledged. Mailed notices shall be deemed to be received on the third business day following the date of mailing. Notices sent by overnight courier shall be deemed received the following business day.

 

If to COMPANY:    Chief Executive Officer
   Juno Therapeutics, Inc.
   8725 W. Higgins Road, Suite 290
   Chicago, IL 60631
If to ST. JUDE:    Director, Office of Technology Licensing
   St. Jude Children’s Research Hospital
   262 Danny Thomas Place, Mail Stop 742
   Memphis, Tennessee
   Phone: (901) 595-2342
   Fax: (901) 595-3148

10.8 Compliance with All Laws. In all activities undertaken pursuant to this AGREEMENT, LICENSOR and COMPANY covenant and agree that each will in all material respects comply with such Federal, state and local laws and statutes, as may be in effect at the time of performance and all valid rules, regulations and orders thereof regulating such activities.

10.9 Successors and Assigns. Neither this AGREEMENT nor any of the rights or obligations created herein, except for the right to receive any remuneration hereunder, may be assigned by either PARTY, in whole or in part, without the prior written consent of the other PARTY, except that either PARTY shall be free to assign this AGREEMENT without the consent of the other party (i) to any AFFILIATED COMPANY at least having an ability comparable to COMPANY in performing under this AGREEMENT, or (ii) in the case of the COMPANY, in connection with any sale of substantially all of its assets of COMPANY relating to this AGREEMENT, but in each case, shall provide written notice of such assignment and assumption along with an executed copy thereof or of the written notice of a change of control, as the case may be, within thirty (30) days of its occurrence. This AGREEMENT shall bind and inure to the benefit of the successors and permitted assigns of the PARTIES hereto.

 

[ ### ] = REDACTED INFORMATION


10.10 No Waivers; Severability. No waiver of any breach of this AGREEMENT shall constitute a waiver of any other breach of the same or other provision of this AGREEMENT, and no waiver shall be effective unless made in writing. Any provision hereof prohibited by or unenforceable under any applicable law of any jurisdiction shall as to such jurisdiction be deemed ineffective and deleted herefrom without affecting any other provision of this AGREEMENT. It is the desire of the PARTIES hereto that this AGREEMENT be enforced to the maximum extent permitted by law, and should any provision contained herein be held by any governmental agency or court of competent jurisdiction to be void, illegal and unenforceable, the PARTIES shall negotiate in good faith for a substitute term or provision which carries out the original intent of the PARTIES.

10.11 Entire Agreement; Amendment. COMPANY and LICENSOR acknowledge that they have read this entire AGREEMENT and that this AGREEMENT, including the attached Exhibits constitutes the entire understanding and contract between the PARTIES hereto and supersedes any and all prior or contemporaneous oral or written communications with respect to the subject matter hereof. It is expressly understood and agreed that (i) there being no expectations to the contrary between the PARTIES hereto, no usage of trade, verbal agreement or another regular practice or method dealing within any industry or between the PARTIES hereto shall be used to modify, interpret, supplement or alter in any manner the express terms of this AGREEMENT; and (ii) this AGREEMENT shall not be modified, amended or in any way altered except by an instrument in writing signed by both of the PARTIES hereto.

10.12 Delays or Omissions. Except as expressly provided herein, no delay or omission to exercise any right, power or remedy accruing to any PARTY hereto, shall impair any such right, power or remedy to such PARTY nor shall it be construed to be a waiver of any such breach or default, or an acquiescence therein, or waiver or acquiescence in any similar breach or default, or be deemed a waiver or acquiescence of any other breach or default theretofore or thereafter occurring. Any waiver, permit, consent or approval of any kind or character on the part of any PARTY of any breach or default under this AGREEMENT, or any waiver on the part of any PARTY of any provisions or conditions of this AGREEMENT, must be in writing and shall be effective only to the extent specifically set forth in such writing. All remedies either under this AGREEMENT or by law or otherwise afforded to any PARTY, shall be cumulative and not alternative.

10.13 Force Majeure. If a PARTY fails to fulfill its obligations hereunder (other than an obligation for the payment of money), when such failure is due to an act of God, or other circumstances beyond its reasonable control, including but not limited to fire, flood, civil commotion, riot, war (declared and undeclared), revolution, epidemics, terrorism, earthquake or embargoes, then said failure shall be excused for the duration of such event and for such a time thereafter as is reasonable to enable the parties to resume performance under this AGREEMENT, provided however, that in no event shall such time extend for a period of more than one hundred eighty (180) days.

10.14 Further Assurances. Each PARTY shall, at any time, and from time to time, prior to or after the EFFECTIVE DATE of this AGREEMENT, at reasonable request of the other PARTY, execute and deliver to the other such instruments and documents and shall take such actions as may be required to more effectively carry out the terms of this AGREEMENT.

 

[ ### ] = REDACTED INFORMATION


10.15 Survival. The provisions of Paragraphs 3.2 – 3.8 (with respect to fees and other amounts accruing prior to termination, and in connection with sales after termination pursuant to Paragraphs 9.5 and 9.6, shall survive expiration or termination of the AGREEMENT. All representations, warranties, covenants and agreements made herein and which by their express terms or by implication are to be performed after the expiration and/or termination hereof, or are prospective in nature, shall survive such expiration and/or termination, as the case may be. This shall include Paragraphs 5.1 (Reports), 5.2 (Records), and Articles 7, 8, and 10.

10.16 No Third Party Beneficiaries. Nothing in this AGREEMENT shall be construed as giving any person, firm, corporation or other entity, other than the PARTIES hereto and their successors and permitted assigns, any right, remedy or claim under or in respect of this AGREEMENT or any provision hereof.

10.17 Headings. Article headings are for convenient reference and not a part of this AGREEMENT. All Exhibits are incorporated herein by this reference.

10.18 Counterparts. This AGREEMENT may be executed in counterparts, each of which shall be deemed an original and all of which when taken together shall be deemed but one instrument.

 

[ ### ] = REDACTED INFORMATION


IN WITNESS WHEREOF, this AGREEMENT shall take effect as of the EFFECTIVE DATE when it has been executed below by the duly authorized representatives of the parties.

 

JUNO THERAPEUTICS, INC.      ST. JUDE CHILDREN’S RESEARCH HOSPITAL, INC.

/s/ Hans Bishop

    

/s/ William E. Evans

Name: Hans Bishop      Name: William E. Evans
Title: CEO      Title: Director and CEO

Dec 3 rd , 2013

    

Dec 3, 2013

(Date)      (Date)

EXHIBIT A. PATENT RIGHTS LIST

EXHIBIT B. LICENSE FEE & ROYALITIES

EXHIBIT C. DEVELOPMENTAL MILESTONES & MILESTONE PAYMENTS

EXHIBIT D: SALES & ROYALTY REPORT FORM

EXHIBIT E: MATERIAL TRANSFER AGREEMENT – BASIC RESEARCH

EXHIBIT F; MATERIAL TRANSFER AGREEMENT – CLINICAL RESEARCH

 

[ ### ] = REDACTED INFORMATION


EXHIBIT A

PATENT RIGHTS LIST

U.S. Patent No. 8,399,645, titled “Chimeric Receptors with 4-1BB Stimulatory Signaling Domain”

[###]

 

 

[ ### ] = REDACTED INFORMATION


EXHIBIT B

LICENSE FEE & ROYALTIES

1. License Fee: The license fee due under Paragraph 3.1 within [###] of the EFFECTIVE DATE is twenty-five million U.S. dollars ($25,000,000).

2. Minimum Annual Royalties: The minimum annual royalties pursuant to Paragraph 3.2 are:

 

  1 st year—January 1, 2015:    One hundred thousand U.S. dollars ($100,000)
  2 nd year—January 1, 2016:    One hundred thousand U.S. dollars ($100,000)
  January 1 of every year thereafter during the term of the Agreement:    Five hundred thousand U.S. dollars ($500,000)

3. Royalties: The running royalty rate payable under Paragraph 3.3 is [###] percent ([###]%) of NET SALES. [###]. If a LICENSED PRODUCT OR LICENSED SERVICE is covered by more than one patent or patent application within the PATENT RIGHTS, [###].

4. SUBLICENSE CONSIDERATION: The SUBLICENSE CONSIDERATION payable under Paragraph 3.4 is as follows:

LICENSOR shall receive [###] of SUBLICENSE CONSIDERATION.

 

[ ### ] = REDACTED INFORMATION


EXHIBIT C

[###]

 

[ ### ] = REDACTED INFORMATION


EXHIBIT D

[###]

 

 

[ ### ] = REDACTED INFORMATION


EXHIBIT E

[###]

 

[ ### ] = REDACTED INFORMATION


EXHIBIT F

[###]


EXHIBIT 3.02(b)

Basis for Other Royalties

Section 9.3(h)(i) of the Penn-Novartis Collaboration sets out certain royalties that are to be paid by Novartis to Penn, as specified in a table set forth in that section (the “ Table ”). The following two tables, collectively, in this Exhibit 3.02 restate the Table after giving effect to certain changes agreed by Novartis and Penn in connection with the overall transactions contemplated by this Agreement and reflect such royalty payment obligations between Novartis and Penn as of the Effective Date (which shall form the basis for the calculation contemplated under Section 3.02(b)). The calculation of such royalties take into consideration the definition of “Initial CD19 Product” provided for in the Penn-Novartis Collaboration since the royalties that may become due to Penn under the Penn-Novartis Collaboration depend on (A) if the Initial CD19 Product is a CART19 Product or a humanized CART19 Product and (B) if the Initial CD19 Product is not a CART19 Product or a humanized CART19 Product:

A. If the Initial CD19 Product is a CART19 Product or a humanized CART19 Product, then:

 

Worldwide Annual Net Sales of a Product (on a Product-by-Product basis)
during the applicable Calendar Year during the Royalty Term:

   I. Royalty Rate
Applicable to any Initial
CD19 Product:
  II. Royalty Rate
Applicable to any
Product other
than an Initial
CD19 Product:

Portion less than or equal to $[***]:

   [***]%   [***]%

Portion greater than $[***], but less than or equal to $[***]:

   [***]%   [***]%

Portion greater than $[***]:

   [***]%   [***]%

B. If the Initial CD19 Product is not a CART19 Product or a humanized CART19 Product, then:

 

 

Worldwide Annual Net Sales of a Product (on a Product-by-Product
basis) during the applicable Calendar Year during the Royalty Term:

   I. Royalty Rate
Applicable to any
Initial CD19
Product:
  IIA. Royalty Rate
Applicable to
CART19 Product
and any
humanized
CART19 Product:
  IIB. Royalty Rate
Applicable to any
Product other than
an Initial CD19
Product or any
CART19 Product
and any humanized
CART19 Product:

Portion less than or equal to $[***]:

   [***]%   [***]%   [***]%

Portion greater than $[***], but less than or equal to $[***]:

   [***]%   [***]%   [***]%

Portion greater than $[***]:

   [***]%   [***]%   [***]%

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


EXHIBIT 3.06(a)(i)

LETTER TO THE EDITOR

NEW ENGLAND JOURNAL OF MEDICINE

“Dear [insert name of editor]:

We write to request that the New England Journal of Medicine publish the following addendum in connection with the articles referenced below:

[***]

Thank you for your prompt consideration of this request.”

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


EXHIBIT 3.06(a)(ii)

LETTER TO THE EDITOR

SCIENCE TRANSLATIONAL MEDICINE

“Dear [insert name of editor]:

We write to request that Science Translational Medicine publish the following addendum in connection with the article referenced below:

[***]

Thank you for your prompt consideration of this request.”

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


EXHIBIT 4.01

FORM OF ROYALTY REPORT

QUARTERLY SALES & ROYALTY REPORT

[***]

[***]

 

[***]

  

[***]

  

[***]

  

[***]

  

[***]

  

[***]

  

[***]

 

 

[***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


EXHIBIT 5.02

FORM OF DISMISSAL

(see attachment)

 


IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

 

TRUSTEES OF THE UNIVERSITY OF

PENNSYLVANIA and NOVARTIS

PHARMACEUTICALS CORPORATION,

 

Plaintiffs and

Counter-Defendants,

 

v.

 

ST. JUDE CHILDREN’S RESEARCH

HOSPITAL, INC. and

JUNO THERAPEUTICS, INC.,

 

Defendants and

Counterclaimants.

 

  

 

Civil Action No. 2:13-CV-01502-SD

ST. JUDE CHILDREN’S RESEARCH

HOSPITAL, INC. and JUNO

THERAPEUTICS, INC.,

 

Counterclaimants ,

 

v.

 

NOVARTIS PHARMACEUTICALS

CORPORATION and NOVARTIS

INSTITUTES FOR BIOMEDICAL

RESEARCH, INC.,

 

Counter-Defendants .

  

STIPULATION OF DISMISSAL PURSUANT TO FED. R. CIV. P. 41(a)(1)(ii)

Whereas Plaintiff Trustees of the University of Pennsylvania (“the University”), Plaintiff and counterclaim-defendant Novartis Pharmaceuticals Corporation, Counterclaim-defendant Novartis Institutes for Biomedical Research, Inc. (together with Novartis Pharmaceuticals Corporation, “Novartis”), Defendant and


Counterclaimant St. Jude Children’s Research Hospital, Inc. (“St. Jude”), and Defendant and Counterclaimant Juno Therapeutics, Inc. (“Juno”) (the University, Novartis, St. Jude and Juno, collectively, the “Parties”) have entered into agreements resolving the above-captioned litigation, the Parties, through their undersigned counsel, hereby stipulate and agree as follows:

 

1. Subject to paragraph 2 below, the above-captioned litigation, including all claims, counterclaims and affirmative defenses, is dismissed with prejudice. Subject to any contractual relationships that exist between or among any of the Parties, each of the Parties is to bear its own costs and attorney’s fees.;

 

2. The rights of the University and Novartis to assert non-infringement, invalidity and unenforceability of U.S. Patent No. 8,399,645 by way of counterclaim or defense in the event that the patent is, in the future, asserted against them, are preserved.


Dated: April     , 2015   
Madeline M. Sherry (PA Bar I.D. No. 31549)    Abraham C. Reich (PA Bar I.D. No. 20060)
GIBBONS, P.C.    Robert S. Tintner (PA Bar I.D. No. 73865)
1700 Two Logan Square    FOX ROTHSCHILD LLP
18th & Arch Streets    2000 Market Street, 20 th Floor
Philadelphia, PA 19103-2769    Philadelphia, PA 19103-3222
Phone: 215-446-6201    Phone: 215-299-2000
Fax: 215-446-6311    Fax: 215-299-2150
David K. Barr ( pro hac vice )    Morgan Chu ( pro hac vice )
Aaron Stiefel ( pro hac vice )    Andrei Iancu ( pro hac vice )
Richard A. De Sevo ( pro hac vice )    Alan J. Heinrich ( pro hac vice )
Abigail Langsam ( pro hac vice)    IRELL & MANELLA LLP
KAYE SCHOLER LLP    1800 Avenue of the Stars, Suite 900
250 W. 55th Street    Los Angeles, CA 90067-4276
New York, NY 10019-9710    Phone: 310-277-1010
Phone: 212-836-8000    Fax: 310-203-7199
Fax: 212-836-8639   
   Attorneys for Juno Therapeutics, Inc.

Attorneys for Novartis Pharmaceuticals Corporation

and Novartis Institutes for BioMedical Research, Inc.

  
   Daniel Segal (PA Bar I.D. No. 26218)
Eric Kraeutler (PA Bar I.D. No. 32189)    HANGLEY ARONCHICK SEGAL PUDLIN &
John V. Gorman (PA Bar I.D. No. 80631)    SCHILLER
Deborah W. Frey (PA Bar I.D. No. 310717)    One Logan Square, 27 th Floor
Aaron V. Skrypski (PA Bar I.D. No. 209336)    Philadelphia, PA 19103
MORGAN, LEWIS & BOCKIUS LLP    Phone: 215-496-7300
1701 Market Street   
Philadelphia, PA 19103-2921    Glenn L. Krinsky ( pro hac vice )
Phone: 215-963-5000    JONES DAY
Fax: 215-963-5001    555 South Flower Street, 50 th Floor
   Los Angeles, CA 90071
Attorneys for Trustees of the University of    Phone: 213-489-3939
Pennsylvania   
   Alan E. Friedman ( pro hac vice )
   FOLEY & LARDNER LLP
   555 South Flower Street, Suite 3500
   Los Angeles, CA 90028
   213-972-4500
   Attorneys for St. Jude Children’s Research Hospital,
   Inc.


EXHIBIT 8.03(d)

RECIPIENTS OF THE PENN CONSTRUCT

 

Institution

  

Contact(s)

  

Address

  

Date(s) of Transfer

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

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


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

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


EXHIBIT 8.03(e)

THIRD PARTIES

Novartis Institutes for BioMedical Research, Inc.

250 Massachusetts Avenue

Cambridge, MA 02139


EXHIBIT 13.10(a)

NOVARTIS STANDBY STATEMENT

Novartis and its co-party, the Trustees of the University of Pennsylvania, have settled their litigation with St. Jude Children’s Research Hospital, Inc. and Juno Therapeutics, Inc. involving patent and contract claims relating to our chimeric antigen receptor (CAR) CTL019 research and development program. Under the litigation settlement, all of the parties claims are dismissed, and Novartis is licensed to continue research, development and commercialization of CTL019 and subsequent CART-19 therapy programs that may be within the scope of the patent that was the subject of the litigation.

Our collaboration with Penn was formed to bring important new therapies to patients who are in desperate need of new treatment options. We are proud to be working with Carl June and the renowned researchers from Penn.

The clinical trials to date have indicated that CTL019 has the potential to treatrelapsed/refractory acute lymphoblastic leukemia and shows potential in other B-cell malignancies for patients who have exhausted all other treatment options.

Questions & answers

Q1Why did you settle with Juno?

A1With the litigation behind us, we can focus on bringing this important therapy to patients. Novartis is licensed to continue research, development and commercialization of CTL019 and subsequent CART-19 therapy programs that may be within the scope of the patent that was the subject of the litigation.

Q2 What are the terms of the settlement?

A2Novartis will receive a non-exclusive license from Juno to the licensed patents. In exchange, Novartis will provide to Juno:

 

  Initial payment of $12.25 million

 

  Future milestone payments

 

  low to mid single digit royalties—dependent upon geography

Q3Does this outcome impact the progress/development of CTL019 or other CAR research programs conducted by Novartis and Penn?

A3No. Novartis is licensed to continue research, development and commercialization of CTL019 and subsequent CART-19 therapy programs that may be within the scope of the patent that was the subject of the litigation.

Q4How is CTL019 different from the Juno therapy?

A4Each CAR therapy is unique and the therapies being developed cannot be broadly defined as a single “class.” Although there are some similarities, these are complex programs that use different approaches and are derived from a patient’s own T cells. [Note, Juno has three “founding partners” (MSKCC, Fred Hutchinson Cancer Center,and Seattle Children’s Hospital) each of which have different CART-19 products under development]


EXHIBIT 13.10(b)

JUNO PRESS RELEASE


JUNO THERAPEUTICS ANNOUNCES PATENT LITIGATION SETTLEMENT

SEATTLE (April     , 2015) – Juno Therapeutics, Inc. (NASDAQ: JUNO) today announced that it entered into a settlement agreement to resolve litigation with the Trustees of the University of Pennsylvania (“Penn”) and Novartis Pharmaceuticals Corporation (“Novartis”). Juno became a party to the litigation after it entered into a December 2013 license agreement with St. Jude Children’s Research Hospital (“St. Jude”), also a party in the litigation, for patent rights owned by St. Jude. The litigation itself, which began in July 2012 in connection with a contract dispute between St. Jude and Penn, was broadened in March 2013 to include a dispute concerning St. Jude’s U.S. Patent No. 8,399,645, titled “Chimeric Receptors with 4-1BB Stimulatory Signaling Domain.”

Under the terms of the settlement, Novartis agreed to make payments to Juno including an initial payment of $12.25 million, future milestone payments, and mid-single digit royalties from U.S. net sales of product candidates related to the disputed contract and patent claims, as well as a low double digit percentage of the royalties Novartis pays to Penn for global net sales for those product candidates. Payments received by Juno will be shared with St. Jude under the terms of the license agreement between Juno and St. Jude. The parties also agreed to dismiss all claims in the relevant legal proceedings.

“We are pleased by this settlement, which benefits patients by allowing each party to advance its promising cancer immunotherapies and rewards the investigators on whose insights those developments are based,” said Juno CEO, Hans Bishop.

About Juno

Juno Therapeutics, Inc. (“Juno”) is building a fully integrated biopharmaceutical company focused on revolutionizing medicine by re-engaging the body’s immune system to treat cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Multiple product candidates have shown compelling evidence of tumor shrinkage in the clinical trials in refractory leukemia and lymphoma conducted to date. The company’s long-term aim is to improve and leverage its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world’s leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children’s Research Institute, and The National Cancer Institute.

www.JunoTherapeutics.com


Forward Looking Statements

This press release contains forward-looking statements, including statements regarding the dismissal of certain litigation, future payments related to the settlement of that litigation, and the benefits of that settlement. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: payments related to the settlement, the success, cost and timing of product development activities and clinical trials; the ability to obtain regulatory approval for and to commercialize product candidates; and regulatory requirements and regulatory developments; and Juno’s ability to obtain, maintain, or protect intellectual property rights related to its product candidates; amongst others. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Juno’s business in general, see Juno’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 19, 2015. These forward-looking statements speak only as of the date hereof, and Juno disclaims any obligation to update these forward-looking statements.

Investor Relations Contact:

David Walsey, W2O Group

dwalsey@w2ogroup.com , 858-617-0772

Media Contact:

Andreas Marathovouniotis, W2O Group

amarathis@w2ogroup.com , 212-301-7174

# # #

Exhibit 10.4

FIRST AMENDMENT TO LEASE AGREEMENT

THIS FIRST AMENDMENT TO LEASE AGREEMENT (this “ First Amendment ”) is made as of May 21, 2015, by and between ARE-SEATTLE NO. 16, LLC , a Delaware limited liability company (“ Landlord ”), and JUNO THERAPEUTICS, INC. , a Delaware corporation (“ Tenant ”).

RECITALS

A. Landlord and Tenant are parties to that certain Lease Agreement dated as of April 6, 2015 (the “ Lease ”). Pursuant to the Lease, Tenant shall lease certain premises consisting of a minimum of three floors (the “ Premises ”) in that certain to be constructed building located at 400 Dexter Avenue North, Seattle, Washington. Capitalized terms used herein without definition shall have the meanings defined for such terms in the Lease.

B. Landlord and Tenant desire to amend the Lease to, among other things, (i) document which floors Tenant has selected as the Initial Premises and Fixed Expansion Premises and (ii) reflect the order in which Tenant shall be required to lease the Expansion Floors in the Fixed Expansion Premises.

NOW, THEREFORE , in consideration of the foregoing Recitals, which are incorporated herein by this reference, the mutual promises and conditions contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Landlord and Tenant hereby agree as follows:

 

1. Initial Premises . The Initial Premises shall mean approximately 90,423 rentable square feet of the Building, consisting of (i) the 9 th floor containing approximately 23,586 rentable square feet, (ii) the 10 th floor containing approximately 23,586 rentable square feet, (iii) the 11 th floor containing approximately 23,586 rentable square feet, and (iv) the 12 th floor containing approximately 19,665 rentable square feet, and all of the same together shall constitute the Premises. The Premises are more particularly shown on Exhibit A attached hereto. The Rentable Area of the Premises and the Building shall be determined prior to the Rent Commencement Date as provided for in Section 5 of the Lease.

 

2. Security Deposit . As required under the Lease, the Security Deposit required in connection with the Premises is hereby increased from $320,000 to $361,698.56. Tenant shall be required, on or before the date that it is 10 days after the date of this First Amendment, to deliver to Landlord a new Letter of Credit for the additional $41,698.56 or an amendment to the existing Letter of Credit increasing the same by $41,698.56.

 

3. Right to Expand . The first paragraph of Section 39 of the Lease along with Section 39(a) , ( b)  and (c)  of the Lease are all hereby deleted in their entirety and replaced with the following:

“39. Rights to Expand . Subject to the provisions of this Section 39 , Tenant shall have certain rights to expand the Premises to include the Fixed Expansion Premises. The 6 th floor containing approximately 23,558 rentable square feet, the 7 th floor containing approximately 23,726 rentable square feet, and the 8 th floor containing approximately 23,726 rentable square feet are collectively referred to herein as the “ Fixed Expansion Premises ”, and each is individually referred to herein as an “Expansion Floor ”. Tenant shall be required to expand the Premises pursuant to Section 39(a) , (b)  and (c)  in the order of the floor most contiguous to the least contiguous vis-a-vis the Initial Premises (i.e., expansion in the order of first the 8 th floor, then the 7 th floor and finally the 6 th floor).

 

LOGO

 

1


(a) Initial Fixed Expansion Option . Subject to the terms of this Section 39 , Tenant shall have the right (the “ Initial Expansion Right ”), but not the obligation to expand the Premises for Tenant’s own use to include one, two or three of the Expansion Floors. For the avoidance of any doubt, in no event may Tenant elect to exercise its Initial Expansion Right for any partial floor(s). If Tenant elects to exercise its Initial Expansion Right with respect to 1 or more full Expansion Floors of the Fixed Expansion Premises, Tenant shall deliver written notice (an “ Initial Expansion Election Notice ”) to Landlord on or before the date that is 6 months after the Commencement Date (“ Initial Option Expiration Date ”) identifying the number of floors of the Fixed Expansion Premises with respect to which Tenant elects to exercise its Initial Expansion Right (“ Identified Initial Expansion Premises ”). For the avoidance of any doubt, (i) if Tenant elects to lease only 1 Expansion Floor pursuant to the Initial Expansion Right, then such Expansion Floor shall be the 8 th floor, and (ii) if Tenant elects to lease only 2 Expansion Floors pursuant to the Initial Expansion Right, then such Expansion Floors shall be the 8 th floor and the 7 th floor. If Tenant elects not to exercise the Initial Expansion Right, the 6 th floor shall be released from the Fixed Expansion Premises and Tenant shall have no further right to lease the 6 th floor pursuant to the provisions of Section 39(a) , (b)  and/or (c) . If Tenant timely delivers an Initial Expansion Election Notice to Landlord, Tenant shall lease the Identified Initial Expansion Premises on the same terms and conditions pursuant to which Tenant is leasing the initial Premises, except as otherwise provided in this Section 39(a) .

If Tenant timely exercises its Initial Expansion Right with respect to one or more Expansion Floors of the Fixed Expansion Premises, (i) Landlord shall Deliver the Identified Initial Expansion Premises to Tenant within 10 days after Landlord’s receipt of Tenant’s Initial Expansion Election Notice with the Building Shell for the Identified Initial Expansion Premises in Tenant Improvement Work Readiness Condition so that Tenant may commence construction of tenant improvements in the Identified Initial Expansion Premises, (ii) commencing on the earlier of (x) the date that is 6 months after Landlord Delivers the Identified Initial Expansion Premises to Tenant pursuant to subsection (i), and (y) the Substantial Completion of the tenant improvements in the Identified Initial Expansion Premises (as applicable, the “ Initial Option Premises Commencement Date ”), the Premises shall be expanded to include the Identified Initial Expansion Premises and Tenant shall commence paying Base Rent with respect to the Identified Initial Expansion Premises on a per rentable square foot basis at the then-current Base Rent per rentable square foot being paid with respect to the initial Premises, as adjusted pursuant to Section 4 , (iii) Tenant shall not be entitled to any abatement of Base Rent with respect to the Identified Initial Expansion Premises, (iv) commencing on the Initial Option Premises Commencement Date, the definition of “ Tenant’s Share of Operating Expenses ” shall be proportionately increased to include the Identified Initial Expansion Space and Tenant shall commence paying Tenant’s Share of Operating Expenses with respect to the Identified Initial Expansion Premises, and (v) Tenant shall be entitled to a tenant improvement allowance for tenant improvements in the Identified Initial Expansion Premises in the amount of $145.00 per rentable square foot of the Identified Initial Expansion Premises and the tenant improvements shall be designed and constructed (and the funds for the same disbursed) on substantially similar terms as the Work Letter. The parties shall execute an amendment to this Lease documenting Tenant’s leasing of the Identified Initial Expansion Premises on the terms set forth herein promptly after Tenant delivers to Landlord the Initial Expansion Election Notice.

(b) Second Fixed Expansion Option . Subject to the terms of this Section 39 , Tenant shall have the right (the “ Second Expansion Right ”), but not the obligation, to expand the Premises for Tenant’s own use to include (v) the 8 th floor if Tenant did not elect to exercise its Initial Expansion Right, (w) the 8 th floor and the 7 th floor if Tenant did not elect to exercise its Initial Expansion Right with respect to the 8 th floor, (x) the 7 th floor if Tenant elected to exercise its Initial Expansion Right for the 8 th floor, (y) the 7 th floor and the 6 th floor if Tenant elected to exercise its Initial Expansion Right with respect to the 8 th floor, or (z) the 6 th floor if Tenant elected to exercise its Initial Expansion Right with respect to the 8 th floor and the 7 th floor. For the avoidance of any doubt, in no event may Tenant elect to exercise its Second Expansion

 

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Right for any partial floor(s). If Tenant elects to exercise its Second Expansion Right for the Expansion Floor(s) described in the first sentence of this Section 39(b) , Tenant shall deliver written notice (an “ Second Expansion Election Notice ”) to Landlord on or before the date that is 18 months after the Commencement Date (“ Second Option Expiration Date ”) exercising its Second Expansion Right and identifying whether Tenant is electing option (v), (w), (x), (y) or (z) as the floor(s) to be leased pursuant to Tenant’s Second Expansion Right (as applicable, the “ Identified Second Expansion Premises ”). If Tenant elects not to exercise the Second Expansion Right and Tenant did not elect to lease the 8 th floor and 7 th floor as part of the Initial Expansion Right, the 7 th floor shall be released from the Fixed Expansion Premises and Tenant shall have no further right to lease the 7 th floor pursuant to the provisions of Section 39(a) , (b)  and/or (c) . If Tenant timely delivers a Second Expansion Election Notice, Tenant shall lease the Identified Second Expansion Premises on the same terms and conditions pursuant to which Tenant is leasing the initial Premises, except as otherwise provided in this Section 39(b) .

If Tenant timely exercises its Second Expansion Right with respect to one or both remaining floors of the Fixed Expansion Premises, (i) Landlord shall Deliver the Identified Second Expansion Premises to Tenant within 10 days after Landlord’s receipt of Tenant’s Second Expansion Election Notice with the Building Shell for the Identified Second Expansion Premises in Tenant Improvement Work Readiness Condition so that Tenant may commence construction of the tenant improvements in the Identified Second Expansion Premises, (ii) commencing on the earlier of (x) the date that is 6 months after Landlord Delivers the Identified Second Expansion Premises to Tenant pursuant to subsection (i), and (y) the Substantial Completion of the tenant improvements in the Identified Second Expansion Premises (as applicable, the “ Second Option Premises Commencement Date ”), the Premises shall be expanded to include the Identified Second Expansion Premises and Tenant shall commence paying Base Rent with respect to the Identified Second Expansion Premises on a per rentable square foot basis at the then-current Base Rent per rentable square foot being paid with respect to the initial Premises, as adjusted pursuant to Section 4 , (iii) Tenant shall not be entitled to any abatement of Base Rent with respect to the Identified Second Expansion Premises, (iv) commencing on the Second Option Premises Commencement Date, the definition of “ Tenant’s Share of Operating Expenses ” shall be proportionately increased to include the Identified Second Expansion Space Tenant and Tenant shall commence paying Tenant’s Share of Operating Expenses with respect to the Identified Second Expansion Premises, and (v) Tenant shall be entitled to a tenant improvement allowance for tenant improvements in the Identified Second Expansion Premises in the amount of $145.00 per rentable square foot of the Identified Second Expansion Premises, and the tenant improvements shall be designed and constructed (and the funds for the same disbursed) on substantially similar terms as the Work Letter. The parties shall execute an amendment to this Lease documenting Tenant’s leasing of the Identified Second Expansion Premises on the terms set forth herein promptly after Tenant delivers to Landlord the Second Expansion Election Notice.

(c) Third Fixed Expansion Option . Subject to the terms of this Section 39 , Tenant shall have the right (the “ Third Expansion Right ”), but not the obligation to expand the Premises for Tenant’s own use to include (as applicable, the “ Third Expansion Premises ”) (y) the 8 th floor if Tenant did not lease the 8 th floor pursuant to its Initial Expansion Right or its Second Expansion Right or (z) the 6 th floor if Tenant elected to exercise its Initial Expansion Right with respect to the 8 th floor and Tenant elected to exercise its Second Expansion Right with respect to the 7 th floor. For the avoidance of any doubt, in no event may Tenant elect to exercise its Third Expansion Right for any partial portion of such floor. If Tenant elects to exercise its Third Expansion Right with respect to the Third Expansion Premises, Tenant shall deliver written notice (a “ Third Expansion Election Notice ”) to Landlord of such election on or before the date that is 30 months after the Commencement Date (“ Third Option Expiration Date ”). If Tenant has not delivered to Landlord a Third Expansion Notice prior to the Third Option Expiration Date, Tenant shall be deemed to have forever waived its right to lease the Third Expansion Premises and Tenant shall have no further rights to expand the Premises under this Section 39(a) , (b)  and/or (c) . If Tenant timely delivers a Third Expansion Election Notice, Tenant shall lease the Third Expansion Premises on the same terms and conditions pursuant to which Tenant is leasing the initial Premises, except as otherwise provided in this Section 39(c) .

 

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If Tenant timely exercises its Third Expansion Right, (i) Landlord shall Deliver the Third Expansion Premises to Tenant within 10 days after Landlord’s receipt of Tenant’s Third Expansion Election Notice with the Building Shell for the Third Expansion Premises in Tenant Improvement Work Readiness Condition so that Tenant may commence construction of the tenant improvements in the Third Expansion Premises, (ii) commencing on the earlier of (x) the date that is 6 months after Landlord Delivers the Third Expansion Premises to Tenant pursuant to subsection (i), and (y) the Substantial Completion of the tenant improvements in the Third Expansion Premises (as applicable, the “ Third Option Premises Commencement Date ”), the Premises shall be expanded to include the Third Expansion Premises and Tenant shall pay Base Rent with respect to the Third Expansion Premises on a per rentable square foot basis at the then-current Base Rent per rentable square foot being paid with respect to the initial Premises, as adjusted pursuant to Section 4 , (iii) Tenant shall not be entitled to any abatement of Base Rent with respect to the Third Expansion Premises, (iv) commencing on the Third Option Premises Commencement Date, the definition of “ Tenant’s Share of Operating Expenses ” shall be proportionately increased to include the Third Expansion Premises and Tenant shall commence paying Tenant’s Share of Operating Expenses with respect to the Third Expansion Premises, and (v) Tenant shall be entitled to a tenant improvement allowance for tenant improvements in the Third Expansion Premises (x) in the amount of $145.00 per rentable square foot of the Third Expansion Premises if Tenant delivers a Third Expansion Election Notice prior to the last day of 25 th month after the Commencement Date, or (y) in an amount prorated based on $145.00 per rentable square foot of the Third Expansion Premises and the number of months remaining in the Base Term from and after the Third Option Premises Commencement Date, if Tenant delivers a Third Expansion Election Notice after the last day of the 25 th month after the Commencement Date (for example, if Tenant delivers a Third Expansion Election Notice during the 30 th month after the Commencement Date then Tenant shall be entitled to a tenant improvement allowance equal to $82.86 per rentable square foot of the Third Expansion Premises). The tenant improvements for the Third Expansion Premises shall be designed and constructed (and the funds for the same disbursed) on substantially similar terms as the Work Letter. The parties shall execute an amendment to this Lease documenting Tenant’s leasing of the Third Expansion Premises on the terms set forth herein promptly after Tenant delivers to Landlord the Third Expansion Election Notice.”

The rentable area of the Fixed Expansion Premises shall be determined prior to the Rent Commencement Date as provided for in Section 5 of the Lease. The Fixed Expansion Premises are more particularly shown on Exhibit B attached hereto.

 

4. Miscellaneous .

a. This First Amendment is the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior and contemporaneous oral and written agreements and discussions including, without limitation, that certain letter dated April 30, 2015, from Tenant to Landlord. This First Amendment may be amended only by an agreement in writing, signed by the parties hereto.

b. This First Amendment is binding upon and shall inure to the benefit of the parties hereto, and their respective successors and assigns.

c. This First Amendment may be executed in any number of counterparts, each of which shall be deemed an original, but all of which when taken together shall constitute one and the same instrument. The signature page of any counterpart may be detached therefrom without impairing the legal effect of the signature(s) thereon provided such signature page is attached to any other counterpart identical thereto except having additional signature pages executed by other parties to this First Amendment attached thereto.

 

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d. Except as amended and/or modified by this First Amendment, the Lease is hereby ratified and confirmed and all other terms of the Lease shall remain in full force and effect, unaltered and unchanged by this First Amendment. In the event of any conflict between the provisions of this First Amendment and the provisions of the Lease, the provisions of this First Amendment shall prevail. Whether or not specifically amended by this First Amendment, all of the terms and provisions of the Lease are hereby amended to the extent necessary to give effect to the purpose and intent of this First Amendment.

(Signatures on next page)

 

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IN WITNESS WHEREOF , Landlord and Tenant have executed this Lease as of the day and year first above written.

 

  TENANT:
  JUNO THERAPEUTICS, INC.,
  a Delaware corporation
  By:   

/s/ Bernard J. Cassidy

  Its:    Secretary & General Counsel
  LANDLORD:
 

ARE-SEATTLE NO. 16, LLC ,

a Delaware limited liability company

  By:    ALEXANDRIA REAL ESTATE EQUITIES, L.P.,
     a Delaware limited partnership,
     managing member
     By:    ARE-QRS CORP.,
        a Maryland corporation,
        general partner
        By:   

Jackie Clem

        Its:    Senior Vice President, Legal Affairs

 

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LANDLORD’S ACKNOWLEDGMENT

A notary public or other officer completing this certificate verifies only the identity of the individual who signed the document to which this certificate is attached, and not the truthfulness, accuracy, or validity of that document.

 

STATE OF CALIFORNIA    )         
   )  §         
County of Los Angeles       )      

On May 21, 2015, before me, Charles L. Murphy, a Notary Public, personally appeared Jackie Clem who proved to me on the basis of satisfactory evidence to be the person (s) whose name (s) is /are subscribed to the within instrument and acknowledged to me that he/ she /they executed the same in his/ her /their authorized capacity (ies), and that by his/ her /their signature (s) on the instrument the person (s) , or the entity upon behalf of which the person (s) acted, executed the instrument.

I certify under PENALTY OF PERJURY under the laws of the State of California that the foregoing paragraph is true and correct

WITNESS my hand and official seal.

 

/s/ Charles L. Murphy

  
Signature of Notary   

(Affix seal here)

  

/seal/

 

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TENANT’S ACKNOWLEDGMENT

 

STATE OF WASHINGTON      
   ss.   
COUNTY OF KING      

On this 19 day of May, 2015, before me personally appeared Barney Cassidy, to me known to be the General Counsel of Juno Therapeutics, a             , that executed the within and foregoing instrument, and acknowledged the said instrument to be the free and voluntary act and deed of said corporation for the uses and purposes therein mentioned, and on oath stated that they were authorized to execute said instrument.

IN WITNESS WHEREOF, I have hereunto set my hand and affixed my official seal the day and year first above written.

 

/s/ Patricia Betty Grossbard

(Signature of Notary)

Patricia Betty Grossbard

(Legibly Print or Stamp Name of Notary)
Notary public in and for the State of Washington, residing at 307 Westlake Ave. N. Seattle, WA 98109

My appointment expires 5/12/2016

/seal/

 

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Exhibit A

Initial Premises

 

 

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A-1


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A-2


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A-3


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A-4


Exhibit B

Fixed Expansion Premises

 

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B-1


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B-2


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B-3

Exhibit 10.7

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

AMENDMENT NO. 2

to

EXCLUSIVE LICENSE AGREEMENT

This Amendment No. 2 (this “ Amendmen t No. 2 ”), dated as of June 15, 2015, is entered into between Seattle Children’s Hospital d/b/a Seattle Children’s Research Institute, a Washington non-profit corporation (“ Licensor ”) and Juno Therapeutics, Inc., a Delaware corporation (“ Licensee ”).

BACKGROUND

A. Licensee and Licensor are parties to that certain Exclusive License Agreement dated as of February 13, 2014, as amended by Amendment No. 1 thereto dated August 4, 2014 (the “ License Agreement ”).

B. The parties wish to amend the License Agreement as set forth below.

C. All terms used in this Amendment No. 2 with initial letters capitalized but not defined herein shall have the meaning set forth in the License Agreement.

AGREEMENT

Accordingly, the parties agree as follows:

Section 1. Amendments to License Agreement

1.1 Reservation of Rights. Section 2.3 of the License Agreement is hereby deleted in its entirety and replaced with the following:

“Licensor reserves the right to use and otherwise exploit the Licensed Patents solely for Licensor’s (a): internal non-commercial (i) research, teaching and other education-related purposes, (ii) clinical activities that are not supported by (or intended to benefit) in any way any commercial entity other than Licensee (including cost recovery from individuals or insurance companies as authorized by the FDA pursuant to 21 CFR 312.8 or other applicable laws or regulations), and (iii) development, manufacture and use of products for children and young adults solely in support of the foregoing; in each case, at the facilities of (and under the supervision of) Licensor and its Affiliates; and (b) non-commercial manufacture, at the facilities of (and under the supervision of) Licensor and its Affiliates, of products for the treatment of children and young adults for supply to any other not-for-profit entity solely for use by such not–for-profit entity solely for such not-for-profit entity’s internal non-commercial (i) research, teaching and education-related purposes and (ii) clinical activities that are not supported by (or intended to benefit) in any way any commercial entity other than Licensee (including cost recovery from individuals or insurance companies as authorized by the FDA pursuant to 21 CFR 312.8 or other applicable laws or regulations), provided Licensor covenants that any such supply


will (A) be in writing, and (B) either (i) contain an express written prohibition on the filing by the not-for-profit licensee of any patent application(s) on any invention first conceived and/or reduced to practice by such not-for-profit entity as a result of using such product that would limit any practice of any of the Licensed Patents under this Agreement, or (ii) require that such not-for-profit assign to Licensor any patent application or patent filed on any such invention.

Licensor may also provide non-exclusive, non-sublicensable, non-transferable licenses under the Licensed Patents to any other not-for-profit entity solely for such not-for-profit entity’s internal non-commercial (A) research, teaching and other educational-related purposes, and (B) clinical activities that are not supported by (or intended to benefit) in any way any commercial entity other than Licensee (including cost recovery from individuals or insurance companies as authorized by the FDA pursuant to 21 CFR 312.8 or other applicable laws or regulations); provided Licensor covenants that any such license will (X) be in writing and (Y) either (i) contain an express written prohibition on the filing by the not-for-profit licensee of any patent application(s) on any invention first conceived and/or reduced to practice by such not-for-profit entity as a result of the practice of the Licensed Patents that would limit any practice of any of the Licensed Patents under this Agreement, or (ii) require that the licensee assign to Licensor any patent application or patent filed on any such invention. Any patent application or patent filed in violation of any restriction described in subsection (B)(i) or (Y)(i) above, and/or any patent application or patent described in subsection (B)(ii) and/or (Y)(ii) above, shall, at Licensee’s option, be deemed to be a Licensed Patent.

Licensor shall not exploit the Licensed Patents except as expressly described above in this Section 2.3.”

1.2 Development Milestone Cap. The preamble to Section 3.2 of the License Agreement is hereby deleted and replaced in its entirety with the following language:

“Licensee shall pay Licensor milestone payments in the amounts set forth in this Section 3.2, whether the milestone is met by Licensee, its Affiliates or Sublicensee, payable according to the following schedule for the development milestone payment for each particular Licensed Product (i.e., distinct biological entity) (provided, however, the aggregate milestone payments under this Section 3.2 shall not exceed a total of [***] to Licensor for any Licensed Product that is covered only by a Valid Claim of a patent or patent application that is co-owned by Licensor and FHCRC but not any Valid Claim of any other patent application or patent within the Licensed Patents (“ Development Milestones Fee Cap ”) per Licensed Product, regardless of [***])”

1.3 New Milestone. Section 3.2 of the License Agreement is hereby amended to add a new clause (i) to Section 3.2 that reads as follows:

“A payment of [***] for first achievement [***].”

1.4 Exhibit A Patent List. Exhibit A is hereby amended to add the following patent applications:

 

SERIAL NUMBER

   DESCRIPTION      FILING DATE  

[***]

     [***      [***

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Accordingly, Exhibit A, in full, now reads as follows:

 

SERIAL NUMBER

   DESCRIPTION      FILING DATE  

[***]

     [***      [***

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Section 2. Full Force and Effect

Except as modified by this Amendment No. 2, all other terms and provisions of the License Agreement shall remain in full force and effect. In the event of a conflict between the terms of this Amendment No. 2 and the License Agreement, the terms of this Amendment No. 2 shall control.

 

SEATTLE CHILDREN’S HOSPITAL D/B/A SEATTLE CHILDREN’S RESEARCH INSTITUTE

     JUNO THERAPEUTICS, INC.
By:   /s/ James B. Hendricks      By:    /s/ Hans Bishop
  James B. Hendricks, Ph.D.      Print:    Hans Bishop
  President      Its:    CEO

 

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Exhibit 10.8

Juno Therapeutics, Inc.

307 Westlake Avenue North, Suite 300

Seattle, WA 98109

May 27, 2015

Hyam Levitsky, M.D.

[omitted]

Dear Hy:

I am pleased to offer you a position with Juno Therapeutics, Inc. (the “ Company ”) as Executive Vice President, Research and Chief Scientific Officer, reporting to Hans Bishop, President and Chief Executive Officer, effective as of May 27, 2015 (the “ Start Date ”). Commencing on the Start Date, and during your employment with the Company, you will receive an annual base salary of $400,000, which will be paid semi-monthly in accordance with the Company’s normal payroll procedures. As an employee, you also will be eligible to participate in the employee benefit plans maintained by the Company of general applicability to other employees of the Company.

You will be offered the opportunity to earn an annual incentive bonus (the “ Bonus ”) with a target equal to 40% of your annual base salary (the “ Target ”) upon attainment of certain performance objectives to be determined by the Board of Directors of the Company (the “ Board ”), which Bonus will be prorated in 2015 based on the portion of the year served as an employee. The achievement of such objectives will be determined by the Board. Your Bonus, if earned, will be paid by the later of (i) the fifteenth (15th) day of the third (3rd) month following the close of the Company’s fiscal year in which the bonus is earned or (ii) March 15 following the calendar year in which the Bonus is earned.

In addition, subject to the execution and delivery of this letter by you and by the Company, the Company will recommend that the Board grant you (i) an option award to purchase 175,000 shares of the Company’s Common Stock (the “Option Award” ) and (ii) a restricted stock unit award for 145,000 shares of the Company’s Common Stock (the “RSU Award” ). The recommended Option Award would vest and become exercisable as to 25% of the shares subject thereto on the one (1) year anniversary of the Start Date and as to an additional 1/48 of the shares subject thereto on each monthly anniversary thereafter, subject to your continuing to be a service provider of the Company through the applicable vesting dates. The recommended RSU Award would vest as to 47,500 of the shares subject thereto on the first anniversary of the Start Date, and 32,500 of the shares on each subsequent anniversary of the Start Date, such that 100% of the shares will have vested on the fourth anniversary of the Start Date, subject to your continuing to be a service provider of the Company through the applicable vesting dates. The Option Award and RSU Award would each be subject to the terms and conditions of the Company’s 2014 Equity Incentive Plan and an award agreement thereunder. The Option Award would have an exercise price per share equal to the fair market value per share of the Company’s Common Stock on the date of the grant of such award, as such fair

 


market value is determined in accordance with the 2014 Equity Incentive Plan. The RSU Award agreement would provide that a sufficient number of shares would be automatically sold from such RSU Award, in an arrangement intended to be compliance with Rule 10b5-1 under the Securities Exchange Act of 1934 (the “ Exchange Act ”), at each vest date to cover the Company’s required withholding obligations with respect to the vesting of the RSU Award on such date, and the proceeds of such sale would be provided to the Company for purposes of such withholding.

Should you accept the Company’s offer of employment, the Company will pay you a signing bonus of $500,000 less applicable withholding taxes, on the first payroll date after your Start Date. You will be obliged to pay back to the Company (i) 100% of the amount of the signing bonus if you resign from your employment with the Company without Good Reason on or before the first anniversary of your Start Date, or (ii) 50% of the signing bonus if you resign from your employment with the Company without Good Reason at any time between the first anniversary of your Start Date and the second anniversary of your Start Date.

You will be expected to base your employment with the Company in Seattle, Washington. To assist in your relocation, the Company will reimburse you for reasonable expenses you incur to make this transition, including but not limited to moving expenses, travel expenses, and temporary accommodation expenses related to you and your immediate family relocating to Seattle, maintaining your existing house for a period of one (1) year during the course of your relocation, and with your commute to Seattle prior to such relocation (collectively, “ Relocation Expenses ”), up to a maximum aggregate reimbursement of $100,000. Relocation Expenses must be substantiated in writing (by valid receipts or any other reasonable method of invoicing, showing proof of payment for an eligible relocation or commuting cost), which evidence must be submitted to the Company (or, if instructed by the Company, the Company’s third party relocation vendor) within thirty (30) days any such Relocation Expense is incurred. The Relocation Expenses will only be reimbursed to you if you are an employee of the Company on the date of reimbursement or payment by the Company. The Company will also gross up your income for the amount (if any) required to be withheld by the Company for federal income taxes with respect to reimbursed Relocation Expenses. The Company will not gross up your income for any state income taxes for which you might have obligations prior to your move to the State of Washington, and you will be responsible for making any required income tax payments to such state directly. You will be obliged to pay back to the Company (i) 100% of the reimbursed Relocation Expenses and associated gross up if you resign from your employment with the Company without Good Reason on or before the first anniversary of your Start Date, or (ii) 50% of the reimbursed Relocation Expenses and associated gross up if you resign from your employment with the Company without Good Reason at any time between the first and second anniversaries of your Start Date.

The Company will also reimburse you for up to $5,000 in documented legal expenses incurred by you in connection with obtaining legal advice related to your potential employment with the Company, which amount would be payable to you at the end of the first payroll period following your Start Date.

During your employment, you shall be authorized to incur reasonable documented expenses in the performance of your duties. The Company shall reimburse you for all such expenses promptly after the presentation by you of itemized documentation reflecting such expenditures, all in accordance with the Company’s procedures and policies as adopted and in effect from time to time.

You should be aware that your employment with the Company will be for no specified period and will constitute at-will employment. As a result, you are free to resign at any time, for any reason or for no reason. Similarly, the Company is free to conclude its employment relationship with you at any time, with or

 

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without cause, and with or without notice. We request that, in the event of resignation, you give the Company at least two (2) weeks’ notice. The date you cease providing services for the Company shall be the “ Termination Date ,” provided, however, that, in the event you provide the Company with notice of resignation, the Termination Date shall be the effective date set forth in such notice, unless the you and the Company agree otherwise in writing.

If the Company terminates your employment other than for Cause, death or Disability, or if you terminate your employment for Good Reason, then you will be entitled to receive, subject to your executing and delivering to the Company, after such termination of employment, a written general release and, if desired by the Company, a consulting agreement that requires you to provide reasonable transition services for a period of up to nine (9) months, provided that such agreement shall not expect or require you to perform services that would preclude the termination of your employment from being a “separation from service” from the Company within the meaning of Section 409A of the Internal Revenue Code of 1986, as amended (the “ Code ”) and shall provide for payment of your reasonable out-of-pocket expenses incurred in providing the transition service, each in forms reasonably satisfactory to the Company (collectively, the “ Release ”), that become effective and irrevocable by the sixtieth (60th) day following your termination of employment (the “ Release Deadline Date ”), (i) continuing payments of severance pay (less applicable withholding taxes) for a period of twelve (12) months to be paid periodically in accordance with the Company’s normal payroll policies at a rate equal to the sum of your monthly base salary rate, in each case as in effect immediately prior to your termination (but without taking into, account any reduction of your base salary in breach of this letter), (ii) a pro-rata Bonus, which shall be calculated by multiplying the percentage of the Bonus year that has elapsed through the Termination Date by the greater of (A) your Target; or (B) your progress toward meeting the performance criteria applicable to the current Bonus year pro rated based on the fraction of the year elapsed through the Termination Date, provided that if such termination occurs between the beginning of a calendar year and the date on which a Bonus earned during the prior year has been paid, you will not forfeit any Bonus you have earned during that prior year but will be paid the prior year’s Bonus in an amount determined by the Board pursuant to the Company’s ordinary operation of its annual incentive program, and (iii) if you elect continuation coverage pursuant to the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“ COBRA ”) for you and your eligible dependents within the time period prescribed pursuant to COBRA, the Company will reimburse you for the COBRA premiums for such coverage (at the coverage levels in effect immediately prior to your termination) pursuant to the Company’s normal expense reimbursement policy until the earlier of (A) a period of nine (9) months from the last date of employment of you with the Company, or (B) the date upon which you and/or your eligible dependents become covered under similar plans; provided, however, if the Company determines in its sole discretion that it cannot provide the COBRA benefits without potentially violating applicable law (including, without limitation, Section 2716 of the Public Health Service Act), the Company will in lieu thereof provide to you a taxable monthly payment in an amount equal to the monthly COBRA premium that you would be required to pay to continue your group health coverage in effect on the date of your termination of employment (which amount will be based on the premium for the first month of COBRA coverage), which payments will be made regardless of whether you elect COBRA continuation coverage. In addition, if at any time before the first anniversary of your Start Date your employment by the Company terminates for any reason other than your resignation from your employment with the Company without Good Reason, then the vesting of 47,500 shares of the RSU Award will accelerate so that those shares would vest on the Termination Date rather than on the first anniversary of the Start Date.

 

- 3 -


Notwithstanding anything to the contrary under this letter, if at any time the Company determines in its sole discretion that it cannot provide the payments contemplated by the preceding sentence without violating applicable law (including, without limitation, Section 2716 of the Public Health Service Act), you will not receive such payment or any further reimbursements for COBRA premiums. Notwithstanding the foregoing, if the Release does not become effective and irrevocable by the Release Deadline Date, you will forfeit any right to severance payments or other separation benefits under this letter. In no event will severance payments or other separation benefits be paid or provided until the Release actually becomes effective and irrevocable. Except as required by the following paragraph, if the Release becomes effective by the Release Deadline Date, severance payments and other separation benefits under this letter will commence on the Release Deadline Date. Except as required by the following paragraph, any installment payments that would have been made to you during the period from the date of your termination of employment through the date the Release becomes effective and irrevocable but for the preceding sentence will be paid to you on the Release Deadline Date, and the remaining payments will be made as provided in this letter.

Notwithstanding anything to the contrary in this letter, any severance payments or benefits under this letter that would be considered deferred compensation (the  “Deferred Payments” ) under Section 409A of the Internal Revenue Code (as it has been and may be amended from time to time) (the  “Code” ) and any regulations and guidance that has been promulgated or may be promulgated from time to time thereunder ( “Section 409A” ) will not be paid until you have experienced a “separation from service” within the meaning of Section 409A. Additionally, if you are a “specified employee” within the meaning of Section 409A at the time of your separation from service, then the Deferred Payments that would otherwise be due to you on or within the six (6) month period following your separation from service but for this paragraph, will accrue during such six (6) month period and will become payable in a lump sum payment on the date six (6) months and one (1) day following the date of your termination (such rule, the  “Six Month Delay Rule” ). All subsequent Deferred Payments following the application of the Six Month Delay Rule, if any, will be payable in accordance with the payment schedule applicable to each payment. It is the intent of this letter to comply with the requirements of Section 409A so that none of the severance payments will be subject to the additional tax imposed under Section 409A, and any ambiguities or ambiguous terms herein will be interpreted to so comply. Each payment and benefit payable under this letter is intended to constitute a separate payment for purposes of Section 1.409A-2(b)(2) of the Treasury Regulations.

If your employment hereunder is terminated, you are not required to seek other employment or to attempt in any way to reduce any amounts payable to you by the Company. Further, the amount of any payment or benefit provided for hereunder shall not be reduced by any compensation earned by you as a result of your employment by another employer, by retirement benefits, or otherwise.

For purposes of this letter,  “Cause”  means (i) a willful act of dishonesty made by you in connection with your responsibilities as an employee, (ii) your conviction of, or plea of nolo contendere to, a felony or any crime involving fraud, embezzlement or any other act of moral turpitude, or a material violation of federal or state law by you that the Board reasonably determines has had or will have a material detrimental effect on the Company’s reputation or business; (iii) your gross misconduct (as defined under the Revised Code of Washington 50.04.294(4)); (iv) your willful and material unauthorized use or disclosure of any proprietary information or trade secrets of the Company or any other party to whom you owe an obligation of nondisclosure as a result of your relationship with the Company; (v) your willful breach of any material obligations under any written agreement or covenant with the Company; or (vi) your continued substantial failure to perform your employment duties (other than as a result of your physical or mental incapacity) after you have received a written demand of performance from the Board that specifically sets forth the factual basis for the Board’s determination that you have not substantially performed your duties and have failed to cure such non-performance to the Board’s reasonable satisfaction within thirty (30) business days after

 

- 4 -


receiving such notice. For purposes of this paragraph, no act or failure to act shall be considered willful unless it is done in bad faith and without reasonable intent that the act or failure to act was in the best interest of the Company or required by law. Any act, or failure to act, based upon authority or instructions given to you pursuant to a resolution duly adopted by the Board or based on the advice of counsel for the Company will be conclusively presumed to be done or omitted to be done by you in good faith and in the best interest of the Company.

For purposes of this letter,  “Disability”  means: (i) an inability to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or can be expected to last for a continuous period of not less than twelve (12) months; or (ii) receipt of income replacement benefits for a period of not less than three (3) months, by reason of any medically determinable physical or mental impairment which can be expected to last for a continuous period of not less than twelve (12) months, under an accident and health plan covering employees of the Company.

For purposes of this letter,  “Good Reason”  means your resignation within thirty (30) days following expiration of any Company cure period (discussed below) following the occurrence of one or more of the following, without your written consent: (i) a material reduction in your base salary (in which case, severance for a resignation shall be based upon your base salary prior to the reduction); (ii) a material diminution of your duties, responsibilities or reporting lines; (iii) a change in the location of your employment of more than fifty (50) miles; or (iv) the Company’s material breach of the terms of this letter (which shall include the failure of the Board to substantially grant the Option Award and/or RSU Award described on pages 1 and 2 of this letter) or any other material written agreement or covenant with you related to your provision of services to the Company. You will not resign for Good Reason without first providing the Company with written notice of the acts or omissions constituting the grounds for Good Reason within ninety (90) days of the initial existence of the grounds for Good Reason and a reasonable cure period of not less than thirty (30) days following the date of such notice (during which the grounds have not been cured).

You acknowledge and agree that you will disclose to the Company any and all agreements that may affect your eligibility to be employed by the Company or limit the manner in which you may be employed. It is the Company’s understanding that any such agreements will not prevent you from performing the duties of your position and you represent that such is the case. Please notify the Company immediately if this is not the case. Similarly, you agree not to bring any third party confidential information to the Company, including that of any former employer, and that in performing your duties for the Company you will not in any way utilize any such information.

You agree that, during the term of your employment with the Company, you will not, without the prior written consent of the Company, engage in any other employment, occupation, consulting or other business activity directly related to the business in which the Company is now involved or becomes involved during the term of your employment. Notwithstanding the foregoing sentence, the Company understands that during the period between the Start Date and December 31, 2015, you will be involved in closing your research lab at Johns Hopkins University School of Medicine and assisting associated students, post-doctoral fellows and technicians to conclude or transition research and agrees that you may complete this outside work so long as it does not materially interfere with the performance of your obligations to the Company. The Company agrees that any intellectual property in the field of cancer immunology that is produced by research activities of this lab performed during or prior to this transition period are not Company Inventions (as defined in the At-Will Employment Agreement attached as Exhibit A hereto) and that you may amend the List of Prior Inventions and Original Works of Authorship up to and including January 31, 2016 to include such intellectual property as Prior Inventions.

 

- 5 -


As a Company employee, you will be expected to abide by the Company’s rules and standards. Specifically, you will be required to sign an acknowledgment that you have read and that you understand the Company’s rules of conduct and other policies which are included or referenced in “The People Pact” (the Company’s employee handbook), which the Company will provide to you. To the extent that policies set forth in The People Pact conflict with those set forth in this offer letter, the offer letter shall control.

You are also required to sign and comply with an At Will Employee Agreement, in the form attached as Exhibit A hereto, which requires, among other provisions, the assignment of patent rights to any invention made during your employment at the Company, and non-disclosure of Company proprietary information. To the extent that provisions set forth in the At Will Employee Agreement conflict with those set forth in this offer letter, the offer letter shall control.

In the event of any dispute or claim relating to or arising out of our employment relationship, you and the Company agree that (i) any and all disputes between you and the Company shall be fully and finally resolved by binding arbitration, (ii) both you and the Company are waiving and hereby waive any and all rights to a jury trial but all court remedies will be available in arbitration, (iii) all disputes shall be resolved by a neutral arbitrator acceptable to you and the Company who shall issue a written opinion, and (iv) the Company shall pay all the arbitration fees, except an amount equal to the filing fees you would have paid had you filed a complaint in a court of law. Please note that we must receive your signed At Will Employee Agreement by the Start Date or the terms and provisions of this letter shall terminate.

The Company will recommend to the Board that you be deemed an “executive officer” of the Company within the meaning of Item 401(b) of Regulation S-K under the Securities Act of 1933 and for purposes of Section 16 under the Exchange Act. In such event, you will become subject to Section 16 of the Exchange Act, including reporting requirements for transactions in the Company’s equity securities. In order to enable the Company to assist you with fulfilling such reporting requirements, you will be asked to sign and deliver the Section 16 power of attorney attached hereto as Exhibit B . The Company will also offer you the opportunity to enter into an indemnification agreement with the Company for your benefit, on the Company’s standard form of indemnification agreement for its directors and officers, as filed with the Securities and Exchange Commission.

To accept the Company’s terms of employment described herein, please sign and date this letter in the space provided below and return it to the Company by May 27, 2015 . This letter and the At Will Employee Agreement set forth the terms of your employment with the Company and supersede any prior representations or agreements, whether written or oral. This letter may not be modified or amended except by a written agreement signed by the Chief Executive Officer of the Company and you.

 

- 6 -


We look forward to working with you at Juno Therapeutics, Inc.

 

Sincerely,

/s/ Hans Bishop

Hans Bishop

Chief Executive Officer, Juno Therapeutics, Inc.

Agreed to and accepted:

 

Signature:  

/s/ Hyam Levitsky

Printed Name:   Hyam Levitsky
Date: May 27, 2015

Enclosures

 

- 7 -

Exhibit 10.12

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

AMENDED AND RESTATED

MASTER RESEARCH AND COLLABORATION AGREEMENT

by and among

JUNO THERAPEUTICS, INC.

and

CELGENE CORPORATION

and

CELGENE RIVOT LTD.

Dated as of August 13, 2015

 

 


TABLE OF CONTENTS

 

         Page  

ARTICLE 1 DEFINITIONS

     2   
        1.1   “Accounting Principles”      2   
        1.2   “Active Program”      2   
        1.3   “Affiliate”      2   
        1.4   “Antibody”      2   
        1.5   “Antibody Construct”      2   
        1.6   “Antitrust Law”      2   
        1.7   “BD Designated Program”      3   
        1.8   “BD Program”      3   
        1.9   “Biologics License Application” or “BLA”      3   
        1.10   “Biologic Therapeutic”      4   
        1.11   “Biomarker”      4   
        1.12   “Business Combination”      4   
        1.13   “Business Day”      4   
        1.14   “Calendar Quarter”      4   
        1.15   “Calendar Year”      4   
        1.16   [***]      5   
        1.17   “Cancer Target”      5   
        1.18   “CAR”      5   
        1.19   “CAR/TCR Product”      5   
        1.20   “CAR T-Cell”      5   
        1.21   “CD19 Program”      5   
        1.22   “CD22 Program”      5   
        1.23   “Celgene Background IP”      5   
        1.24   “Celgene Development Candidate(s)”      5   
        1.25   “Celgene Excluded Programs”      6   
        1.26   “Celgene IP”      7   
        1.27   “Celgene Know-How”      7   
        1.28   “Celgene Option Exercise Notice”      7   
        1.29   “Celgene [***] Program”      7   
        1.30   “Celgene Patents”      7   
        1.31   “Celgene Platform Technology”      8   
        1.32   “Celgene Products”      8   
        1.33   “Celgene Program”      8   
        1.34   “Celgene Resulting Patents”      9   
        1.35   “Celgene Scope”      9   
        1.36   “Celgene Scope Term”      9   
        1.37   “Celgene Target”      9   
        1.38   “Celgene Upstream Agreements”      9   
        1.39   “Cellular Therapy Development Candidate”      9   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

i


         Page  
        1.40   “Cellular Therapy Products”      9   
        1.41   “Chemistry, Manufacturing and Controls”      10   
        1.42   “China Territory”      10   
        1.43   “Claims”      10   
        1.44   “Clinical Trial”      10   
        1.45   “Co-Development and Co-Commercialization Agreement”      10   
        1.46   “Co-Co Program”      10   
        1.47   “Co-Co Product”      10   
        1.48   “Collaboration IP”      10   
        1.49   “Combination Product”      11   
        1.50   “Commercialization”      11   
        1.51   “Commercialization Activities”      11   
        1.52   “Commercialization Opt-In Right”      11   
        1.53   “Commercialization Opt-In Terms”      11   
        1.54   “Commercialization Plan”      12   
        1.55   “Commercially Reasonable Efforts”      12   
        1.56   “Confidential Information”      12   
        1.57   “Control”, “Controls” or “Controlled”      12   
        1.58   “Cooperative Efforts”      13   
        1.59   “Core Dossier Study”      13   
        1.60   “Cover”, “Covering” or “Covered”      13   
        1.61   “Damages”      13   
        1.62   “Data Package”      13   
        1.63   “Data Package Verification Date”      14   
        1.64   “Defense”      15   
        1.65   “[***]”      15   
        1.66   “Development”      15   
        1.67   “Development Candidate”      15   
        1.68   “Development & Commercialization Agreement”      15   
        1.69   “Development Plan”      15   
        1.70   “Diagnostic Product”      16   
        1.71   “Dollars” or “$”      16   
        1.72   “Effective Date”      16   
        1.73   “Eligible BD Program”      16   
        1.74   “EMA”      16   
        1.75   “Engineered T-Cell”      16   
        1.76   “Equity Purchase Agreement”      16   
        1.77   “EU”      16   
        1.78   “Ex Vivo Modification”      16   
        1.79   “[***] Juno Product”      16   
        1.80   “Executive Officers”      17   
        1.81   “FDA”      17   
        1.82   “Field”      17   
        1.83   “FTE”      17   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

ii


          Page  
        1.84    “FTE Rate”      17   
        1.85    “Funding Agreement”      17   
        1.86    “Good Clinical Practices” or “GCP”      17   
        1.87    “Good Laboratory Practices” or “GLP”      17   
        1.88    “Good Manufacturing Practices” or “GMP”      18   
        1.89    “Governmental Authority”      18   
        1.90    “Hatch Waxman Act”      18   
        1.91    “IIT”      18   
        1.92    “Immune Cell Target”      18   
        1.93    “[***] Agent”      18   
        1.94    “[***]” or “[***]”      19   
        1.95    “[***]”      19   
        1.96    “[***]”      20   
        1.97    “Immunology Target”      20   
        1.98    “Immuno-Oncology Target”      20   
        1.99    “In Vivo Development Candidate”      21   
        1.100    “IND”      21   
        1.101    “IND Enabling Studies”      21   
        1.102    “Indication”      21   
        1.103    “[***] Juno Product”      21   
        1.104    “Inventions”      21   
        1.105    “In Vivo Product”      21   
        1.106    “Joint Resulting Patents”      21   
        1.107    “Juno Background IP”      21   
        1.108    “Juno Component”      22   
        1.109    “Juno Development Candidate”      22   
        1.110    “Juno IP”      23   
        1.111    “Juno Know-How”      23   
        1.112    “Juno Option Exercise Notice”      23   
        1.113    “Juno [***] Program”      23   
        1.114    “Juno Patents”      23   
        1.115    “Juno Platform Technology”      23   
        1.116    “Juno Products”      23   
        1.117    “Juno Program”      23   
        1.118    “Juno Reagents”      25   
        1.119    “Juno Resulting Patents”      25   
        1.120    “Juno Scope”      25   
        1.121    “Juno Scope Term”      25   
        1.122    “Juno Target”      25   
        1.123    “Juno Upstream Agreements”      25   
        1.124    “Know-How”      26   
        1.125    “Law” or “Laws”      26   
        1.126    “Lead Development Candidate”      26   
        1.127    “Licensed Product”      26   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

iii


         Page  
        1.128   “Litigation Conditions”      26   
        1.129   “MAA”      26   
        1.130   “Major EU Market Countries”      26   
        1.131   “Manufacture”      26   
        1.132   “MHLW”      27   
        1.133   “NK Cells”      27   
        1.134   “New Drug Application” or “NDA”      27   
        1.135   “North America Territory”      27   
        1.136   “Option”      27   
        1.137   “Option Exercise Notice”      27   
        1.138   “Option Exercise Window”      27   
        1.139   “Option Term”      28   
        1.140   “Patent”      28   
        1.141   “Patient Sample”      28   
        1.142   “Permitted Pre-Option Obligations”      29   
        1.143   “Person”      29   
        1.144   “Phase 1a Clinical Trial”      29   
        1.145   “Phase 1b Clinical Trial”      29   
        1.146   “Phase 2 Clinical Trial”      29   
        1.147   “Phase 3 Clinical Trial”      29   
        1.148   “Phase 4 Clinical Trial”      30   
        1.149   “Pivotal Clinical Trial”      30   
        1.150   “Post Option Costs”      30   
        1.151   “Products”      30   
        1.152   “Product Liability”      30   
        1.153   “Profit & Loss Share”      31   
        1.154   “Program”      31   
        1.155   “Prosecution and Maintenance” or “Prosecute and Maintain”      31   
        1.156   “Regulatory Approval”      31   
        1.157   “Regulatory Authority”      31   
        1.158   “Regulatory Materials”      31   
        1.159   “Reimbursable Costs”      32   
        1.160   “Research”      32   
        1.161   “Research Collaboration Term”      32   
        1.162   “Resulting Patents”      32   
        1.163   “ROW Territory”      33   
        1.164   “Small Molecule Compound”      33   
        1.165   “Specific Agent”      33   
        1.166   “Specifically Directed”      33   
        1.167   “Sublicensee”      33   
        1.168   “Target”      33   
        1.169   “T-Cell”      33   
        1.170   “TCR”      34   
        1.171   “TCR T-Cell”      34   

 

iv


         Page  
        1.172   “Territory”      34   
        1.173   “Third Party”      34   
        1.174   “United States” or “U.S.”      34   
        1.175   “[***] BD Program”      34   
        1.176   “[***] Program”      34   
        1.177   “[***] Program”      34   
        1.178   “[***] Celgene Background Patents”      35   
        1.179   “[***] Juno Background Patents”      35   
        1.180   “Upfront Payment”      35   
        1.181   “Vaccine”      35   
        1.182   “Valid Claim”      35   
        1.183   “[***] Juno Products”      35   
        1.184   Additional Definitions      35   

ARTICLE 2 COLLABORATION AND DEVELOPMENT

     40   
        2.1   Scope and Collaboration Overview      40   
        2.2   Business Development Activities      42   
        2.3   Development and Regulatory Responsibilities      46   
        2.4   Safety Information      49   
        2.5   Reports; Results; Testing by the Parties      50   
        2.6   No Representation      50   
        2.7   Subcontracting      50   
        2.8   Material Transfer      50   
        2.9   Reversion of Rights      52   
        2.10   Manufacture and Supply      53   
        2.11   Obligations of Affiliates.      55   

ARTICLE 3 OPTION EXERCISE; DEVELOPMENT & COMMERCIALIZATION AGREEMENTS

     55   
        3.1   Option Grant and Exercise      55   
        3.2   Government Approvals      68   
        3.3   Obligations of Affiliates.      71   

ARTICLE 4 GOVERNANCE

     71   
        4.1   Generally      71   
        4.2   Joint Steering Committee      72   
        4.3   Joint Research and Development Committee      75   
        4.4   Joint Manufacturing Committee      77   
        4.5   Joint Business Development Committee      78   
        4.6   Joint Commercialization Committee      80   
        4.7   Patent Committee      82   
        4.8   Exceptions to Decision-Making Authority      84   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

v


         Page  

ARTICLE 5 EXCLUSIVITY; [***]

     85   
        5.1   Exclusivity.      85   
        5.2   Post-Option      89   
        5.3   Other Exceptions      91   
        5.4   Clinical Combinations      93   
        5.5  

[***]

     93   

ARTICLE 6 FINANCIAL TERMS

     94   
        6.1   Upfront Payment      94   
        6.2   Research Expenses      94   
        6.3   Option Exercise Payments for Certain Programs      94   
        6.4   Designation Payments      95   
        6.5   Designation Payment Structure      97   
        6.6   Additional Payment Terms      98   
        6.7   Tax Withholding      99   

ARTICLE 7 INTELLECTUAL PROPERTY

     101   
        7.1   Licenses      101   
        7.2   Ownership      105   
        7.3   Prosecution and Maintenance of Patents      107   
        7.4   Defense of Claims Brought by Third Parties      111   
        7.5   Enforcement of Patents Prior to Exercise of Option      112   
        7.6   Patent Term Extensions      114   
        7.7  

[***]

     115   
        7.8   Limitation as to [***] Patents      115   
        7.9   Third Party Licenses      115   

ARTICLE 8 CONFIDENTIALITY

     116   
        8.1   Nondisclosure      116   
        8.2   Exceptions      117   
        8.3   Authorized Disclosure      117   
        8.4   Terms of this Agreement      119   
        8.5   Securities Filings      119   
        8.6   Publicity      119   
        8.7   Permitted Publications      121   
        8.8   Relationship to Existing Confidentiality Agreement      121   
        8.9   Relationship with Other Agreements      122   
        8.10   Reversion of Rights upon Expiration of the Option Term      122   
        8.11   Clinical Trials Registry      122   

ARTICLE 9 REPRESENTATIONS AND WARRANTIES

     122   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

vi


         Page  
        9.1   Representations and Warranties of Both Parties      122   
        9.2   Representations and Warranties of Juno      123   
        9.3   Representations and Warranties of Celgene      124   
        9.4   Covenants      125   
        9.5   Disclaimer      127   

ARTICLE 10 INDEMNIFICATION; INSURANCE

     128   
        10.1   Indemnification by Celgene      128   
        10.2   Indemnification by Juno      128   
        10.3   Notice of Claims      129   
        10.4   Indemnification Procedures      129   
        10.5   Indemnification Following Exercise of the Option      130   
        10.6   LIMITATION OF LIABILITY      130   

ARTICLE 11 TERM AND TERMINATION

     131   
        11.1   Term; Expiration      131   
        11.2   Termination for Breach      131   
        11.3   Voluntary Termination      132   
        11.4   Termination for Bankruptcy      132   
        11.5   Termination for Patent Challenge      132   
        11.6   Termination for Failure to Close Share Purchase Agreement or Breach of Standstill      133   
        11.7   Effects of Expiration or Termination      133   
        11.8   Juno Reversion Compounds      135   
        11.9   Celgene Reversion Compounds      136   
        11.10   Surviving Provisions      137   

ARTICLE 12 MISCELLANEOUS

     139   
        12.1   Severability      139   
        12.2   Notices      139   
        12.3   Force Majeure      140   
        12.4   Assignment      141   
        12.5   Waivers and Modifications      143   
        12.6   Waiver of Jury Trial      143   
        12.7   Choice of Law; Jurisdiction; Venue      143   
        12.8   Arbitration      144   
        12.9   Relationship of the Parties      146   
        12.10   Entire Agreement      146   
        12.11   Counterparts      146   
        12.12   Equitable Relief      146   
        12.13   Interpretation      146   
        12.14   Celgene Parties      147   

 

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         Page  
        12.15   Further Assurances      148   

EXHIBIT A

  

EXHIBIT B

  

EXHIBIT C

  

EXHIBIT D

  

LIST OF EXHIBITS

Exhibit A         Form of License Agreement

Exhibit B         Form of Juno Lead Co-Co Agreement

Exhibit C         Form of Celgene Lead Co-Co Agreement

Exhibit D         Form of Material Transfer Agreement

LIST OF SCHEDULES

Schedule 1.25          Celgene [***] Products

Schedule 1.37          Celgene Targets

Schedule 3.1.5         [***] Program - Post-Option Exercise Agreements

Schedule 7.3.6(c)    Core Countries

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

viii


AMENDED AND RESTATED MASTER RESEARCH AND COLLABORATION AGREEMENT

This AMENDED AND RESTATED MASTER RESEARCH AND COLLABORATION AGREEMENT (this “ Agreement ”) is entered into as of August 13, 2015 (the “ Execution Date ”) by and among Juno Therapeutics, Inc., a Delaware corporation (“ Juno ”), and Celgene Corporation , a Delaware corporation (“ Celgene Corp. ”), with respect to all rights and obligations under this Agreement in the United States, and Celgene RIVOT Ltd. (“ Celgene RIVOT ”), with respect to all rights and obligations under this Agreement outside the United States (Celgene RIVOT and Celgene Corp., together, “ Celgene ”). Celgene and Juno are each referred to herein by name or as a “ Party ”, or, collectively, as the “ Parties .”

RECITALS

WHEREAS , Juno is a clinical-stage company engaged in the research and development of novel cellular and other immunotherapies, including for the treatment of cancer and diseases and conditions of the immune system;

WHEREAS , Celgene is engaged in the research, development and commercialization of therapeutic products to treat various diseases and conditions, including for the treatment of cancer;

WHEREAS , the Parties desire to collaborate on the research and development of [***] and immune-targeted therapies for the treatment of cancer and immune disorders;

WHEREAS , each Party will conduct certain research and development activities to identify cell therapies, biologic molecules and small molecule therapeutic compounds directed to certain biologic targets, and the other Party will obtain an exclusive option to enter into a license agreement or a co-development and co-commercialization agreement with such other Party with respect to such molecules and compounds, as further described herein;

WHEREAS , upon exercise of such option, the Parties shall enter into such separate license agreement or co-development and co-commercialization agreement, on the terms and subject to the conditions set forth herein;

WHEREAS , Juno and Celgene are parties to that certain Master Research and Collaboration Agreement, entered into on June 29, 2015 (the “ Original Execution Date ”); and

WHEREAS , the Parties desire to amend and restate such Master Research and Collaboration Agreement in its entirety as set forth herein;

NOW, THEREFORE , in consideration of the foregoing and the mutual agreements set forth below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


ARTICLE 1

DEFINITIONS

1.1 “Accounting Principles” means either U.S. generally accepted accounting principles ( “GAAP” ) or International Financial Reporting Standards ( “IFRS” ), as designated and used by the applicable Party in preparing its financial statements from time to time.

1.2 “Active Program” means any (i) Program being conducted by Juno or Celgene, respectively, for which [***], or (ii) Program that is [***] a Designated Program (to the extent still subject to a Development & Commercialization Agreement) that[***] for such Designated Program [***].

1.3 “Affiliate” means any Person which, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with a Party to this Agreement, or any Development & Commercialization Agreement, if applicable. For purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to a Person means (a) direct or indirect ownership of fifty percent (50%) or more of the voting securities or other voting interest of any Person (including attribution from related parties), or (b) the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through ownership of voting securities, by contract, as a general partner, as a manager, or otherwise. For purposes of this Agreement and any Development & Commercialization Agreement, neither Celgene nor Juno shall be deemed an Affiliate of the other Party.

1.4 “Antibody” means any monoclonal antibody (e.g., [***]. For clarity, a [***] shall not be an Antibody.

1.5 “Antibody Construct” means (a) a [***] Antibody, and (b) any molecule consisting of an [***].

1.6 “Antitrust Law” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the rules and regulations promulgated thereunder (the “HSR Act” ), the Sherman Act, as amended, the Clayton Act, as amended, the Federal Trade Commission Act, as amended, and any other Laws related to merger control or designed to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade, in the following jurisdictions: the United States, all states and territories thereof, Australia, Brazil, Canada, the European Union, Republic of Korea, Japan, Mexico, Taiwan, and any other jurisdiction that Celgene, in its good faith judgment, determines requires a pre-merger notification filing prior to consummation of the transactions contemplated by the Implementing Agreements as defined in Section 3.2 of this Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2


1.7 “BD Designated Program” means a Program that becomes a Designated Program by the exercise of a BD Option by a Party for an Eligible BD Program acquired by the other Party, such BD Designated Program [***] the Party delivering the BD Option Exercise Notice for such Eligible BD Program.

1.8 “BD Program” means activities within the Celgene Scope or the Juno Scope conducted with respect to a program of research, Development or Commercialization activities under a license or other rights acquired by Juno or its Affiliate during the Research Collaboration Term or by Celgene or its Affiliate during the Research Collaboration Term from a Third Party [***] with respect to [***], provided that [***] being acquired by a Party from such Third Party, [***]. Notwithstanding the foregoing: (a) BD Program shall exclude any and all [***]; or (b) subject to clause (a), if a Party [***], such Party will not be [***] with respect to such [***] and the activities conducted with respect to such [***] will not be deemed to constitute a BD Program [***], such Program [***], such Program [***], provided that if, [***], a Party [***] that would have [***], then if such Party [***], such Party shall be [***]. Notwithstanding the foregoing, an [***] Program (i) shall not be treated as a BD Program under Section 2.2, [***], and (ii) shall instead be subject to Section 3.1.5.

1.9 “Biologics License Application” or “BLA” means a Biologics License Application (as more fully described in U.S. 21 C.F.R. Part 601.20 or its successor regulation) and all amendments and supplements thereto submitted to the FDA, or any equivalent filing,

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

3


including an MAA, in a country or regulatory jurisdiction other than the U.S. with the applicable Regulatory Authority, or any similar application or submission for Regulatory Approval filed with a Regulatory Authority to obtain marketing approval for a biologic product in a country or in a group of countries.

1.10 “Biologic Therapeutic” means [***], and in each case of [***], excluding any [***].

1.11 “Biomarker” means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring therapies for such patient, and/or (b) for predicting the outcome of a particular treatment of such patient.

1.12 “Business Combination” means, with respect to a Party, any of the following events: (a) any Third Party (or group of Third Parties acting in concert) acquires, directly or indirectly, shares of such Party representing at least a majority of the voting power (where voting refers to being entitled to vote for the election of directors) then outstanding of such Party; (b) such Party consolidates with or merges into another corporation or entity which is a Third Party, or any corporation or entity which is a Third Party consolidates with or merges into such Party, in either event pursuant to a transaction in which at least a majority of the voting power of the acquiring or resulting entity outstanding immediately after such consolidation or merger is not held by the holders of the outstanding voting power of such Party immediately preceding such consolidation or merger; or (c) such Party conveys, transfers, licenses and/or leases all or substantially all of its assets to a Third Party.

1.13 “Business Day” means a day on which banking institutions in New York City, New York are open for business, excluding any Saturday or Sunday.

1.14 “Calendar Quarter” means the period beginning on the Effective Date, or the effective date of the applicable Development & Commercialization Agreement, as applicable and ending on the last day of the calendar quarter in which the Effective Date or the effective date of the applicable Development & Commercialization Agreement, as applicable, falls, and thereafter each successive period of three (3) consecutive calendar months ending on the last day of March, June, September, or December, respectively; provided that, the final Calendar Quarter shall end on the last day of the Term, the applicable License Term, or the applicable Co-Co Term, as applicable.

1.15 “Calendar Year” means the period beginning on the Effective Date, or the effective date of the applicable Development & Commercialization Agreement, as applicable, and ending on December 31 of the calendar year in which the Effective Date, or the effective date of the applicable Development & Commercialization Agreement, as applicable, falls, and thereafter each successive period of twelve (12) consecutive calendar months beginning on January 1 and ending on December 31; provided that, the final Calendar Year shall end on the last day of the Term, the applicable License Term, or the applicable Co-Co Term, as applicable.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

4


1.16 [***] means a [***]. For example, an [***] is a [***]. An [***] in which the [***] is a “[***]”. For purposes of determining the Parties rights and obligations under Articles 2, 3 and 5, a [***] (a) shall be considered to be [***] and, (b) [***], would result in the [***], to the extent not [***]. Notwithstanding the foregoing, (a) a [***], and (b) [***]. For example, for purposes of determining the Parties rights and obligations under Articles 2, 3, and 5, [***] would result in a [***], to the extent [***], provided that [***].

1.17 “Cancer Target” means a Target that is [***].

1.18 “CAR” means any [***].

1.19 “CAR/TCR Product” means a Product containing or comprising a CAR, TCR, CAR T-Cell or TCR T-Cell.

1.20 “CAR T-Cell” means a T-Cell that expresses one or more CARs on its surface.

1.21 “CD19 Program” means the Juno Program for which the Target is CD19.

1.22 “CD22 Program” means the Juno Program for which the Target is CD22.

1.23 “Celgene Background IP” means Patents and Know-How Controlled by Celgene or its Affiliates that arises from activities conducted prior to or outside of the Collaboration.

1.24 “Celgene Development Candidate(s)” means, on a Celgene Program-by-Celgene Program, Eligible BD Program-by-Eligible BD Program (where Celgene is the BD Acquiring Party) or [***] Program-by-[***] Program ([***]) basis, any [***] Agent that is [***] to the [***] of such [***], [***] Program or [***] Program, and (a) that is [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

5


[***], or (b) if such Program is an Eligible BD Program [***]. It is understood and agreed that prior to Juno’s exercise of an Option or BD Option with respect to a [***], [***], or an [***] Program, Celgene Development Candidates refer to [***] of the Celgene Program, Eligible BD Program [***] that is subject to an Option or BD Option. Following the exercise of the Option with respect to a Celgene Program [***], or the BD Option with respect to such Eligible BD Program for which Celgene is the BD Acquiring Party, Celgene Development Candidates within the resulting Designated Program also include any [***] Agents that may be [***] and that are [***] of such Designated Program (including without limitation [***] that are [***]), [***], that are being Developed and Commercialized under the applicable Development & Commercialization Agreement [***], and such Celgene Development Candidates shall be referred to in such Development & Commercialization Agreements as “Co-Co Candidates” . Notwithstanding the foregoing, Celgene Development Candidate shall [***].

1.25 “Celgene Excluded Programs” means:

 

  (a) [***]:

 

  (i) [***];

 

  (ii) [***];

 

  (iii) [***]; and

 

  (iv) [***]; and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

6


  (b) [***] .

1.26 “Celgene IP” means Celgene Patents and Celgene Know-How.

1.27 “Celgene Know-How” means Know-How Controlled by Celgene or any of its Affiliates as of the Effective Date or at any time during the Term that is (a) [***] any Development Candidate, Product, or related Diagnostic Product, or (b) [***] Development Candidate, Product, or related Diagnostic Product, subject to the following sentence. “Celgene Know-How” shall not include any [***]. Notwithstanding the foregoing, Celgene Know-How shall not include any Know-How that is [***] active ingredients that are not Development Candidates, or Biomarkers in related Diagnostic Products.

1.28 “Celgene Option Exercise Notice” means, on a Juno Program-by-Juno Program basis, the written notice provided to Juno by Celgene pursuant to Section 3.1.3, such notice constituting Celgene’s exercise of its Option with respect to a Juno Program to convert it into a Designated Program.

1.29 “Celgene [***] Program” means any Program under which Celgene or its Affiliates [***] under such Program, where such Program consists of [***] under such Program. For clarity, irrespective of [***], a Celgene [***] Program that [***] shall not be an Eligible BD Program.

1.30 “Celgene Patents” means any and all Patents Controlled by Celgene or its Affiliates as of the Effective Date or at any time during the Term that Cover or claim inventions that are (a) [***] of any Development Candidate, Product, or related Diagnostic Products or (b) [***] any Development Candidate, Product or related Diagnostic Product, subject to the following sentence. “Celgene Patents” shall include any and all Patents within the Celgene Background IP that are within the foregoing subsections (a) and (b), but notwithstanding anything to the contrary in this Section 1.30, shall not include Patents to the extent that such Patents [***]. Notwithstanding anything to the contrary in this Section 1.30, Celgene Patents shall not include any Patents that [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

7


1.31 “Celgene Platform Technology” means any and all Know-How Controlled by Celgene or its Affiliates that is [***] (a) [***], each of the foregoing for use in the Field, and/or (b) [***] in the Field, and in each case of (a) and (b), excluding Know-How that is [***] or to [***] or a Target thereof.

1.32 “Celgene Products” means Celgene In Vivo Products and Celgene Cellular Therapy Products.

1.33 “Celgene Program” means any of the following, as applicable:

(a) a Program, [***], in which activities are within the Celgene Scope and have been, prior to the exercise of a Juno Option therefor, conducted by Celgene and/or its Affiliates, including any such Program (i) to which Celgene acquires a license or rights any time after the Original Execution Date and during the Research Collaboration Term that arises as a result of the exercise of an option by Celgene under a written agreement with a Third Party that was entered into prior to the Original Execution Date, and/or (ii) to which Celgene acquires a license or rights under a written agreement with a Third Party any time after the Original Execution Date and during the Research Collaboration Term, in the case of (ii), where [***] at the time of such acquisition;

(b) any Program that was offered by Celgene and/or its Affiliates [***] Program pursuant to Section 3.1.5, for which Juno has not exercised an Option within the time permitted for such exercise following such offer pursuant to Section 3.1.5, provided that such Program will no longer be a Celgene Program if Juno has not exercised an Option for such Program within the time period permitted following the [***], and such Program will thereafter no longer be within the Collaboration; and

(c) any [***] for which Celgene and/or its Affiliates was the BD Acquiring Party and any [***] Program for which Celgene and/or its Affiliates was the BD Acquiring Party,

and “Celgene Programs” means all of the foregoing. Following the exercise of an Option with respect to a Celgene Program, the activities conducted under the Development & Commercialization Agreement with respect to applicable [***] or such Program shall be referred to in such Development & Commercialization Agreements as a “Celgene Co-Co Program”. Notwithstanding the foregoing, a Celgene Program shall exclude any and all activities to identify, research and Develop [***] that are subject to options to acquire a license or other rights required for Commercialization of such [***] under agreements with Third Parties (including under Funding Agreements) unless or until such option is exercised. In no event will a Celgene Program include a Celgene Excluded Program.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

8


1.34 “Celgene Resulting Patents” means Collaboration Patents Covering or claiming Inventions [***]. For the avoidance of doubt, Celgene Resulting Patents do not include any Patents [***].

1.35 “Celgene Scope” means (a) the identification, research, Development and Commercialization of [***], prior to exercise of an Option for a Program including such Target, the Celgene Scope with respect to such Target shall [***], and subsequent to exercise of such Option, the Celgene Scope with respect to such Target shall [***] and (b) [***].

1.36 “Celgene Scope Term” means the period of ten (10) years from the Effective Date.

1.37 “Celgene Target” means any Target listed on Schedule 1.37(a) , as such list of Targets may be updated or amended by the Parties by mutual agreement from time to time during the Research Collaboration Term. Celgene Targets shall exclude the Target(s) listed on Schedule 1.25 . For clarity, a Celgene Target may also be a Juno Target.

1.38 “Celgene Upstream Agreements” means those agreements listed in the applicable Data Package detailing the obligations of Celgene to any Third Party with respect to a given offered Program, and any amendments thereof or successor agreements or agreements entered into pursuant to the terms of any such agreements.

1.39 “Cellular Therapy Development Candidate” means any Development Candidate that is or contains [***] for administration to a patient for use in the Field.

1.40 “Cellular Therapy Products” means any [***] that constitutes, incorporates, comprises or contains a Cellular Therapy Development Candidate [***], and in all forms, presentations and formulations (including manner of delivery and dosage). For example, [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

9


that constitutes, incorporates, comprises or contains a [***] Cellular Therapy Development Candidate within the Juno Scope is a “ Juno Cellular Therapy Product ”, and [***] that constitutes, incorporates, comprises or contains a [***] Cellular Therapy Development Candidate within the Celgene Scope is a “ Celgene Cellular Therapy Product ”.

1.41 “Chemistry, Manufacturing and Controls” or “CMC” means the part of pharmaceutical development that is directed to the Development and Manufacture of Products, the specifications therefor, and other parameters which indicate that the finished drug or biologic product and the manufacturing process are consistent and controlled, in each case, as specified by the FDA or other applicable Regulatory Authorities in the chemistry, manufacturing and controls section of an IND, BLA or NDA in the United States, or the equivalent section of regulatory filings made outside the United States, and “CMC Activities” means all activities relating to CMC.

1.42 “China Territory” means China, its territories and possessions.

1.43 “Claims” means any and all suits, claims, actions, proceedings or demands brought by a Third Party.

1.44 “Clinical Trial” means a human clinical trial, including any Phase 1a Clinical Trial, Phase 1b Clinical Trial, Phase 2 Clinical Trial, Phase 3 Clinical Trial, any study incorporating more than one of these phases (including a Pivotal Clinical Trial), or any clinical trial commenced after Regulatory Approval (including any Phase 4 Clinical Trial).

1.45 “Co-Development and Co-Commercialization Agreement” means a Juno Lead Co-Co Agreement or a Celgene Lead Co-Co Agreement, as applicable.

1.46 “Co-Co Program” means a Juno Co-Co Program or a Celgene Co-Co Program.

1.47 “Co-Co Product” means, with respect to a Co-Co Program, any product that constitutes, incorporates, comprises or contains a Co-Co Candidate arising under such Co-Co Program, whether or not as the sole active ingredient, and in all forms, presentations and formulations (including manner of delivery and dosage).

1.48 “Collaboration IP” means, collectively:

(a) “Collaboration Know-How” which means all Know-How that is [***], pursuant to the conduct of activities under the Collaboration at any time during the Term; and

(b) “Collaboration Patents which means any Patents that cover or claim any Collaboration Know-How.

For clarity, Collaboration IP does not include either Party’s interest in Joint Collaboration IP.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

10


1.49 “Combination Product” means, any Product comprising a Development Candidate and one or more other active ingredient(s) that is not itself a Development Candidate (such other active ingredients, “ Other Actives ”). For clarification, the term “Other Active,” when referring to an ingredient included in such Product refers to ingredients that are incorporated or included in the Product for [***] (whether in the same or different formulations, or dosed separately or together) for the purpose of [***]; the term excludes such ingredients that are present in such a Product [***].

1.50 “Commercialization” means any and all activities directed to the manufacturing (including Manufacturing) of commercial supply of a product and related diagnostic product, the marketing, detailing, promotion and securing of pricing and reimbursement of such products, whether before or after Regulatory Approval has been obtained (including making, having made, using, importing, selling and offering for sale such product or related diagnostic product), and will include post-launch marketing, promoting, detailing, marketing, research, distributing, customer service, administering and commercially selling such products, importing, exporting or transporting such products for commercial sale, and all regulatory compliance with respect to the foregoing, and “Commercialize” means the performance of any of the foregoing activities. For clarity, “Commercialization” and “Commercialize” do not include any Clinical Trial commenced after Regulatory Approval.

1.51 “Commercialization Activities” means activities conducted by a Party in relation to Commercialization of Products under a Development & Commercialization Agreement in a country where such Party is not the Commercialization Lead Party following the exercise by such Party of (a) the Commercialization Opt-In Right, or (b) the delivery by such Party of a Juno Co-Commercialization Notice pursuant to Section 3.1.2 of the Celgene Lead Co-Co Agreement, or a Celgene Co-Commercialization Notice pursuant to Section 3.1.2 of the Juno Lead Co-Co Agreement, as further described in Section 3.1.6 of the Celgene Lead Co-Co Agreement, Section 3.1.7 of the Juno Lead Co-Co Agreement (each as applicable), and the Commercialization Opt-In Terms for the applicable Development & Commercialization Agreement.

1.52 “Commercialization Opt-In Right” means a Party’s right to opt-in to participate in Commercialization Activities in specified countries where such Party is not the Commercialization Lead Party, in accordance with Section 3.3 of the License Agreement, Section 3.1.3 of the Juno Lead Co-Co Agreement, or Section 3.1.3 of the Celgene Lead Co-Co Agreement, as applicable.

1.53 “Commercialization Opt-In Terms” means the additional terms set forth at Exhibit F to each Development & Commercialization Agreement governing the participation by a Party in Commercialization Activities pursuant to such Development & Commercialization Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

11


1.54 “Commercialization Plan” means, on a Program-by-Program basis, a plan for Commercialization of Products prepared by the Commercialization Lead Party of the Program from which such Product originated and submitted to the JCC for review or amendment, the plan setting forth the Commercialization activities to be performed by the Parties.

1.55 “Commercially Reasonable Efforts” means, with respect to either Party in relation to this Agreement or any Development & Commercialization Agreement, such efforts that are consistent with the efforts and resources used by a biopharmaceutical company of similar size and market capitalization in the exercise of its commercially reasonable business practices relating to an exercise of a right or performance of an obligation under this Agreement or any applicable Development & Commercialization Agreement, as applicable, including the research, development, manufacture, supply and commercialization of a pharmaceutical or biologic compound or product, as applicable, at a similar stage in its research, development or commercial life as the relevant compound or Product, and that has commercial and market potential similar to the relevant compound or Product, taking into account issues of intellectual property coverage, safety and efficacy, stage of development, product profile, competitiveness of the marketplace, proprietary position, regulatory exclusivity, anticipated or approved labeling, present and future market and commercial potential, the likelihood of receipt of Regulatory Approval, profitability (including pricing and reimbursement status achieved or likely to be achieved, amounts payable to licensors of patent or other intellectual property rights other than Juno under this Agreement or any Development & Commercialization Agreement, alternative products and legal issues).

1.56 “Confidential Information” means, with respect to a Party, all non-public, confidential and proprietary information and materials, including Know-How, marketing plans, strategies, and customer lists, in each case, that are disclosed by such Party to the other Party, regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other Party by the disclosing Party in oral, written, visual, graphic or electronic form.

1.57 “Control”, “Controls” or “Controlled” means, with respect to any intellectual property, Know-How or Confidential Information, the ability of a Party, itself or through an Affiliate, (whether through ownership or license (other than a license granted in this Agreement or a Development & Commercialization Agreement, as applicable) to grant to the other Party and/or its Affiliates, as applicable, the licenses or sublicenses as provided herein, in a Development & Commercialization Agreement, or to otherwise disclose such intellectual property, Know-How or Confidential Information to the other Party without violating the terms of any then-existing agreement with any Third Party or misappropriating such Know-How or Confidential Information. Notwithstanding the foregoing, for the purpose of defining whether intellectual property, Know-How or Confidential Information is Controlled by a Party, if such intellectual property, Know-How or Confidential Information is first acquired, licensed or otherwise made available to such Party after the Effective Date, or the effective date of the applicable Development & Commercialization Agreement, as applicable, and if the use, practice or exploitation thereof by or on behalf of the other Party, its Affiliates or sublicensees would require the first Party to pay any amounts to the Third Party from which the first Party acquired,

 

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licensed or otherwise obtained such intellectual property, Know-How or Confidential Information ( “Additional Amounts” ), such intellectual property, Know-How or Confidential Information shall be deemed to be Controlled by the first Party only if the other Party agrees to pay (if necessary) and does in fact pay all Additional Amounts with respect to such other Party’s use of or license to such intellectual property, Know-How or Confidential Information.

1.58 “Cooperative Efforts” means communications, exchanges of information or materials, or discussions between the Parties in conduct of activities under the Collaboration during the Term.

1.59 “Core Dossier Study” means, on a Program-by-Program basis, a core dossier of Clinical Trials and other studies to support Regulatory Approval in multiple jurisdictions for a given Program.

1.60 “Cover”, “Covering” or “Covered” means, with reference to a Patent and a product, composition, article of manufacture, or method, that the manufacture, practice, use, offer for sale, sale or importation of the product, composition, article of manufacture, or method, would infringe a Valid Claim of such Patent in the country in which such activity occurs without a license thereto (or ownership thereof).

1.61 “Damages” means all claims, threatened claims, damages, losses, suits, proceedings, liabilities, costs (including reasonable legal expenses, costs of litigation and reasonable attorney’s fees), or judgments, whether for money or equitable relief, of any kind and is not limited to matters asserted by Third Parties against a Party, but includes claims, threatened claims, damages, losses, suits, proceedings, liabilities, costs (including reasonable legal expenses, costs of litigation and reasonable attorney’s fees), or judgments incurred or sustained by a Party in the absence of Third Party claims; provided, that no Party shall be liable to hold harmless or indemnify the Juno Indemnitees or Celgene Indemnitees, as applicable, for any claims, threatened claims, damages, losses, suits, proceedings, liabilities, costs or judgments for punitive or exemplary damages, except to the extent the Party seeking indemnification is actually liable to a Third Party for such punitive or exemplary damages in connection with a claim by such Third Party.

1.62 “Data Package” means, on a Program-by-Program basis, a data package prepared by a Party with respect to Development activities conducted under a Program by such Party and its Affiliates within the Juno Scope or the Celgene Scope, as applicable, and provided to the other Party promptly following the occurrence of the following events during Development activities conducted by such Parties (each, a “Data Package Trigger Event” ):

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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provided that (i) for the CD19 Program, unless otherwise agreed by the Parties in writing, Juno may provide the [***] Data Package on or before [***], but if Juno [***] following the [***] the CD19 Program, (ii) for the CD22 Program, Juno may provide the [***] Data Package on or before [***], Juno shall [***] following the [***], and (iii) on a Program-by-Program basis, no Data Package shall apply, and neither Party shall have any obligation to provide to the other Party, a Data Package for any Data Package Trigger Event for such Program that has already occurred as of the Effective Date.

Each Data Package shall contain the following, in a form reasonable under the circumstances: (i) a written report [***], (ii) the [***], (iii) the [***], (iv) a list of [***], (v) the [***] Development Candidate that is a [***] Development Candidate that is a [***], as applicable, (vi) to the extent Controlled by a Party, [***] any of the foregoing materials in this subsection (vi) that [***], (vii) a [***] for such Program as of the date upon which such Data Package is provided to the other Party, (viii) a detailed summary of [***], including without limitation [***], and (ix) a [***]. It is understood and agreed that the term “Data Package” is applicable only to a Program that is subject to an Option.

1.63 “Data Package Verification Date” means, with respect to a Data Package prepared by a Development Lead Party (the “Data Package Party” ), the date that is the earlier of: (a) [***] after the date of receipt by a Party of such Data Package; provided, that

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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if such Party requests additional reasonable information and clarifications during the first [***] of such [***] period, then such [***] period will be automatically extended (as necessary) for up to an additional [***] period, during which period such Party may continue to request additional reasonable information and clarifications and the Data Package Party shall provide such information and clarifications to such Party; and (b) a date mutually agreed upon by the Parties for such Data Package. For clarity, in requesting additional reasonable information, a Party may not request [***].

1.64 “Defense” means any actions brought to defend a Patent against a challenge to such Patent, including without limitation reexaminations, inter partes reviews or post-grant reviews, excluding any actions included within Prosecution and Maintenance. “Defend” will have the correlative meaning.

1.65 “[***]” means, on a Designated Program-by-Designated Program basis, (a) those [***] at the time (i) an Option is exercised pursuant to Section 3.1.3, or (ii) a BD Option is exercised pursuant to Section 2.2.1, and (b) [***] for which a Party exercises an Option pursuant to Section 3.1.5, in each case of (a) and (b), [***].

1.66 “Development” means preclinical and clinical drug or biologic product development activities with respect to a therapeutic biologic or drug product or diagnostic product, including: test method development and stability testing, toxicology, formulation, process development, qualification and validation, manufacture scale-up, development-stage manufacturing (including Manufacturing), quality assurance/quality control, Clinical Trials (including Clinical Trials commenced after Regulatory Approval), statistical analysis and report writing, the preparation and submission of BLAs and MAAs, regulatory affairs with respect to the foregoing and all other activities necessary or useful or otherwise requested or required by a Regulatory Authority or as a condition or in support of obtaining or maintaining a Regulatory Approval, and “Develop” means the performance of any of the foregoing activities.

1.67 “Development Candidate” means (a) a Juno Development Candidate, (b) a Celgene Development Candidate, (c) any [***] Program or (d) any [***] Program, as applicable.

1.68 “Development & Commercialization Agreement” means a License Agreement in the form attached hereto as Exhibit A , or a “Juno Lead Co-Co Agreement” in the form attached hereto as Exhibit B , or a “Celgene Lead Co-Co Agreement” in the form attached hereto as Exhibit C , as applicable.

1.69 “Development Plan” means on a Program-by-Program basis, the plan setting forth the research and Development activities to be performed by the Parties following the exercise of the Option or BD Option for such Program, which Development Plan shall be

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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prepared by the Development Lead Party and submitted to the JRDC for review and approval in accordance with the terms of the applicable Development & Commercialization Agreement.

1.70 “Diagnostic Product” means, on a Product-by-Product basis, any product that constitutes, incorporates, comprises or contains a composition, process, method or kit that is necessary or reasonably useful [***] in a patient or Patient Sample, and/or (b) to measure Biomarkers in a patient or Patient Sample, in each case developed for use in connection with the applicable Product, and/or (c) to [***] to achieve improved safety or effectiveness.

1.71 “Dollars” or “$” means the legal tender of the United States.

1.72 “Effective Date” means the date on which all waiting periods under any applicable Antitrust Law in the Territory shall have expired or earlier been terminated with respect to this Agreement and the Equity Purchase Agreement.

1.73 “Eligible BD Program” means a BD Program in which a [***] a BD Acquiring Party licenses or acquires rights or exercises its option to license or acquire rights under such BD Program, [***] (a) (i) where [***] the BD Acquiring Party, [***] (a “[***] BD Program” ), (ii) solely where [***] is the BD Acquiring Party, any other [***] (a “[***] BD Program ”), or (iii) solely where Celgene is the BD Acquiring Party, any [***] (a “[***] BD Program ”), or (b) where [***] is the BD Acquiring Party, within any other BD Program [***] for exercise of a BD Option ([***] BD Programs [***], the “[***] BD Programs ”).

1.74 “EMA” means the European Medicines Agency, and any successor entity thereto.

1.75 “Engineered T-Cell” means a CAR T-Cell or TCR T-Cell.

1.76 “Equity Purchase Agreement” means the Share Purchase Agreement entered into by Celgene and Juno dated June 29, 2015.

1.77 “EU” means, at any particular time, all countries that are officially recognized as member states of the European Union at such particular time.

1.78 “Ex Vivo Modification” means the [***].

1.79 “[***] Juno Product” means a [***] Juno Product that is [***] Juno or its Affiliates [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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1.80 “Executive Officers” means Juno’s Chief Executive Officer and Celgene’s Chief Executive Officer.

1.81 “FDA” means the U.S. Food and Drug Administration, and any successor entity thereto.

1.82 “Field” means any use or purpose, including the treatment, palliation, diagnosis or prevention of any human or animal disease, disorder or condition.

1.83 “FTE” means the equivalent of the work of one (1) full-time employee of a Party or its Affiliates for one (1) year (consisting of [***] hours per year) in directly conducting Research, Development, Manufacture and Commercialization activities hereunder. Any Party’s employee who devotes fewer than [***] hours per year on the applicable activities shall be treated as an FTE on a pro-rata basis, calculated by dividing the actual number of hours worked by such employee on such activities by [***]. Any employee who devotes more than [***] hours per year on the applicable activities shall be treated as one (1) FTE. For the avoidance of doubt, FTE shall not include the work of general corporate or administrative personnel, except for the portion of such personnel’s work time actually spent on conducting scientific or technical activities related to the research Development, Manufacture or Commercialization of Products.

1.84 “FTE Rate” means the rate(s) to be agreed upon by the Parties, associated with each full-time scientific or technical person, or in the case of less than a full-time scientific or technical person, a full-time equivalent scientific or technical person year, carried out by an appropriately qualified employee of a Party or its Affiliates, based on [***] person-hours or greater per year, performing services under this Agreement or the applicable Development & Commercialization Agreement.

1.85 “Funding Agreement” means an agreement pursuant to which a Party or its Affiliate provides funding to a Third Party to [***]; provided that (a) such Party or Affiliate has [***] funds for research or development or to otherwise direct or control such research or development, and (b) [***].

1.86 “Good Clinical Practices” or “GCP” means the ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects as are required by applicable Regulatory Authorities or Law in the relevant jurisdiction. In the United States, GCP shall be based on Good Clinical Practices established through FDA guidances (including Guideline for Good Clinical Practice – ICH Harmonized Tripartite Guideline (ICH E6)), and, outside the United States, GCP shall be based on Guideline for Good Clinical Practice – ICH Harmonized Tripartite Guideline (ICH E6).

1.87 “Good Laboratory Practices” or “GLP” means the then-current good laboratory practice standards promulgated or endorsed by the FDA, as defined in U.S. 21 C.F.R. Part 58 (or such other comparable regulatory standards in jurisdictions outside the United States, as they may be updated from time to time).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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1.88 “Good Manufacturing Practices” or “GMP” means all applicable standards relating to manufacturing practices for fine chemicals, intermediates, bulk products and/or finished pharmaceutical products, including (a) all applicable requirements detailed in the FDA’s current Good Manufacturing Practices regulations, U.S. 21 C.F.R. Parts 210 and 211 and “The Rules Governing Medicinal Products in the European Community, Volume IV, Good Manufacturing Practice for Medicinal Products”, as each may be amended from time to time, and (b) all applicable Laws promulgated by any Governmental Authority having jurisdiction over the manufacture of any Development Candidate, Product or Diagnostic Product, as applicable.

1.89 “Governmental Authority” means any: (a) nation, principality, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, state, local, municipal, foreign or other government; (c) governmental or quasi-governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or entity and any court or other tribunal); (d) multinational organization or body; or (e) individual, entity or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature.

1.90 “Hatch Waxman Act” means Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), as amended and in force during the Term.

1.91 “IIT” means a human clinical study sponsored and conducted by an investigator at a research institution for which a Party or its Affiliate provides develop pharmaceutical compounds or biologic supplies; provided that such Party or Affiliate has no right or ability to direct or control such human clinical study, excluding (a) any human clinical study with a cooperative group, (b) any human clinical study that could reasonably be expected, in and of itself, to be used to obtain a regulatory approval and (c) any human clinical study that includes a head-to-head comparison of any pharmaceutical compound or biologic, either alone or in combination with any other pharmaceutical compound or biologic.

1.92 “Immune Cell Target” means a Target that [***] of the immune system.

1.93 “[***] Agent” or “[***]” means, as to a particular Target, any Specific Agent that:

(a) [***]; or

(b) is a product that [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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[***].

For clarity, a [***] Agent that is an Antibody that functions by (i) [***], and/or (ii) [***], is not an [***].

1.94 “[***]” or “[***]” means, as to a particular Program, [***] Agents within [***] of such Program, with all such [***] Agents [***]. Each of the following is considered a distinct [***]: (i) [***], (ii) [***], (iii) [***], (iv) [***], (v) [***], (vi) [***], (vii) [***], and (viii) [***], except that, within each category in (i)-(viii), all [***] shall be considered within a [***] of such Program (each such [***] deemed a “[***]”). For example, [***] with respect to [***] would include [***] would be within a [***] would include all [***].

1.95 “[***]” means a [***] (a) [***] and (b) [***]. An [***] in which the [***] are [***] “[***]”. For example, each of the following is an [***]: (i) [***], (ii) [***] and (iii) [***]. For purposes of determining the Parties rights and obligations under Articles 2, 3 and 5, an [***] (a) shall be [***] a Program in which the [***] and (b) [***]. Designation of [***]. If, however, a [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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[***], for purposes of determining the Parties rights and obligations under Articles 2, 3, and 5. Notwithstanding the foregoing, (a) [***] Development & Commercialization Agreement, and (b) [***] in the applicable Program. For example, [***], for purposes of determining the Parties rights and obligations under Articles 2, 3, and 5 of this Agreement, [***].

1.96 “[***]” means [***]. [***]. For example, an [***] including [***] within a Program, [***] (such Program, an “[***]”). Unless otherwise agreed by the Parties, [***] in the Program. Designation of [***]. [***], for purposes of determining the Parties rights and obligations under Articles 2, 3, and 5 of this Agreement, such [***]. For example, an [***] shall not alone result in [***]. For the avoidance of doubt if one Party were to opt-in to a [***], under no circumstance would [***] either Party to [***] with respect to [***].

1.97 “Immunology Target” means any [***] Target that (a) is, [***] the immune system, [***], and (b) is not an Immuno-Oncology Target.

1.98 “Immuno-Oncology Target” means any [***] Target that is present [***] (for example, any [***] (including without limitation a [***], where the [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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1.99 “In Vivo Development Candidate ” means any Development Candidate that is developed or intended for in vivo administration to a patient or subject for use in the Field.

1.100 “IND” means an investigational new drug application (including any amendment or supplement thereto) submitted to the FDA pursuant to U.S. 21 C.F.R. Part 312, including any amendments thereto. References herein to IND shall include, to the extent applicable, any comparable filing(s) outside the U.S. for the investigation of any product in any other country or group of countries (such as a Clinical Trial Application (“ CTA ”) in the EU).

1.101 “IND Enabling Studies” means (i) any pharmacokinetic and/or toxicology study conducted under GLP for filing an IND or (ii) in the case of Cellular Therapy Products, initiation of GMP production of the relevant vector.

1.102 “Indication” means any disease or condition, or sign or symptom of a disease or condition.

1.103 “[***] Juno Product” means a [***] Juno Product [***] by Juno or its Affiliates [***].

1.104 “Inventions” means all inventions designed, discovered, generated, invented or conceived by or on behalf of either Party or its respective Affiliates or both Parties or their respective Affiliates, whether solely or jointly with any Third Party, in the course of activities performed under this Agreement or any Development & Commercialization Agreement, as applicable.

1.105 “In Vivo Product” means any therapeutic product or preparation that constitutes, incorporates, comprises or contains an In Vivo Development Candidate. An In Vivo Product within a Juno Program is a “ Juno In Vivo Product ” and an In Vivo Product within a Celgene Program is a “ Celgene In Vivo Product ”.

1.106 “Joint Resulting Patents” means any Patents (a) claiming or Covering subject matter arising from [***] and (b) contained in the Joint Collaboration IP. For the avoidance of doubt, Joint Resulting Patents do not include any Patents [***] independently of [***].

1.107 “Juno Background IP” means Patents and Know-How Controlled by Juno or its Affiliates that arises from activities conducted prior to or outside of the Collaboration.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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1.108 “Juno Component” means any individual element of a Juno Product [***]; it being understood and agreed that such element is not [***] in and of itself.

1.109 “Juno Development Candidate” means, on a Juno Program-by-Juno Program, Eligible BD Program-by-Eligible BD Program (where Juno and/or its Affiliates is the BD Acquiring Party) or [***] Program-by-[***] Program (where Juno and/or its Affiliates is offering such Program to the Collaboration) basis, any of the following, as applicable:

(a) with respect to the CD19 Program, (i) JCAR015, (ii) JCAR014, (iii) JCAR017, (iv) JCAR021, and (v) each [***] Agent that is [***] Juno or any of its Affiliates prior to or after the Effective Date until [***] (the “ CD19 Development Candidates ”);

(b) with respect to the CD22 Program, (i) JCAR018 and (ii) each [***] Agent that is [***] Juno or any of its Affiliates prior to or after the Effective Date until [***] (the “ CD22 Development Candidates ”); and

(c) with respect to each other Juno Program, Eligible BD Program (where Juno and/or its Affiliates is the BD Acquiring Party) or [***] Program that is offered by Juno and/or its Affiliates to the Collaboration, each [***] Agent that is [***] such Juno Program, Eligible BD Program [***], and (a) that is [***] Juno or any of its Affiliates prior to or after the Effective Date until [***], or (b) if such Program is an Eligible BD Program [***], that is offered by Juno and/or its Affiliates to the Collaboration prior to [***],

and “ Juno Development Candidates ” means all of the foregoing. It is understood and agreed that prior to Celgene’s exercise of an Option or BD Option with respect to a Juno Program or Eligible BD Program for which Juno is the BD Acquiring Party, Juno Development Candidates refer to [***], Eligible BD Program or [***] Program that is subject to an Option or BD Option. Following the exercise of the Option with respect to a Juno Program or [***] Program, or the BD Option with respect to such Eligible BD Program for which Juno is the BD Acquiring Party, Juno Development Candidates within the resulting Designated Program also include [***] of such Designated Program (including [***], and which may be [***], that are being Developed and Commercialized under the applicable

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Development & Commercialization Agreement [***], and such Juno Development Candidates shall be referred to herein and in such Development & Commercialization Agreements as “ Licensed Candidates ” (where such Development & Commercialization Agreement is a License Agreement), or as “ Co-Co Candidates ” (where such Development & Commercialization Agreement is a Co-Development and Co-Commercialization Agreement). Notwithstanding the foregoing, Juno Development Candidate shall [***].

1.110 “Juno IP” means the Juno Patents and the Juno Know-How.

1.111 “Juno Know-How” means all Know-How Controlled by Juno or its Affiliates as of the Effective Date or at any time during the Term that is (a) primarily or directly related to and/or reasonably necessary for the [***], including any such Know-How that is within Juno Background IP, subject to the following sentence. “Juno Know-How” shall not include [***]. Notwithstanding the foregoing, Juno Know-How shall not include any Know-How that is [***] active ingredients that are not [***].

1.112 “Juno Option Exercise Notice” means, on a Celgene Program-by-Celgene Program basis, the written notice provided to Celgene by Juno pursuant to Section 3.1.3, such notice constituting Juno’s exercise of its Option to convert such Celgene Program into a Designated Program.

1.113 “Juno [***] Program” means any Program under which Juno or its Affiliates has [***] under such Program, where such Program consists of [***] under such Program. For clarity, irrespective of [***] Agents, a Juno [***] Program that [***] shall not be an Eligible BD Program.

1.114 “Juno Patents” means any and all Patents Controlled by Juno or its Affiliates as of the Effective Date or at any time during the Term that cover or claim inventions that are (a) [***] of any Development Candidate, Product, or related Diagnostic Product or (b) [***] Development Candidate, Product or related Diagnostic Product, subject to the following sentence. “Juno Patents” shall include any and all Patents [***] that are within the foregoing subsections (a) and (b), but notwithstanding anything to the contrary in this Section 1.114, shall not include Patents to the extent that [***]. Notwithstanding anything to the contrary in this Section 1.114, Juno Patents shall not include any Patents [***].

1.115 “Juno Platform Technology” means any and all Know-How Controlled by Juno or its Affiliates that is [***] (a) [***], each of the foregoing for use in the Field, (b) [***], and/or (c) [***] in the Field, and in each case of (a), (b) and (c), excluding Know-How that is [***].

1.116 “Juno Products” means Juno In Vivo Products and Juno Cellular Therapy Products.

1.117 “Juno Program” means any of the following, as applicable:

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(a) any Program, [***] in which activities are within the Juno Scope and have been prior to the exercise of a Celgene Option therefor, conducted by Juno and/or its Affiliates, including (i) the CD19 Program, (ii) the CD22 Program, (iii) any Program to which Juno and/or its Affiliates acquires a license or rights any time after the Original Execution Date and during the Research Collaboration Term that arises as a result of the exercise of an option by Juno and/or its Affiliates under a written agreement with a Third Party that was entered into prior to the Original Execution Date, or (iv) any Program to which Juno and/or its Affiliates acquires a license or rights under a written agreement with a Third Party any time after the Original Execution Date and during the Research Collaboration Term, in the case of (iv), where [***] at the time of such acquisition;

(b) any Program that was offered by Juno and/or its Affiliates as [***] Program pursuant to Section 3.1.5, for which Celgene has not exercised an Option within the time permitted for such exercise following such offer pursuant to Section 3.1.5, provided that such Program will no longer be a Juno Program if Celgene has not exercised an Option for such Program within the time period permitted following the [***], and such Program will thereafter no longer be within the Collaboration; and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(c) any [***] Program for which Juno and/or its Affiliates was the BD Acquiring Party,

and “ Juno Programs ” means all of the foregoing. Following the exercise of an Option with respect to a Juno Program, the activities conducted under a Development & Commercialization Agreement with respect to applicable [***] or such Program shall be referred to herein and in such Development & Commercialization Agreements as a “ Licensed Program ” (where such Development & Commercialization Agreement is a License Agreement), or a Juno Co-Co Program (otherwise). Notwithstanding the foregoing, a Juno Program shall exclude any and all activities to identify, research and Develop [***] that are subject to options to acquire a license or other rights required for Commercialization of such [***] under agreements with Third Parties (including under Funding Agreements) unless or until such option is exercised.

1.118 “Juno Reagents” means [***] Juno Products, or are [***]. For clarity, Juno Reagents may include agents present within a Juno Product solely as a result of their application or inclusion during production, generation or preparation of the Juno Product, such as for ex vivo modification or treatment of cells.

1.119 “Juno Resulting Patents” means Collaboration Patents Covering or claiming Inventions [***]. For the avoidance of doubt, Juno Resulting Patents do not include any Patents [***].

1.120 “Juno Scope” means (i) the identification, research, Development and Commercialization of [***], and (ii) the [***] Commercialization of [***] that (A) [***]. In no event shall activities with respect to Specific Agents Specifically Directed to BCMA be considered within the Juno Scope.

1.121 “Juno Scope Term” means the period of [***] from the Effective Date.

1.122 “Juno Target” means any Immuno-Oncology Target or any Immunology Target, including CD19 and CD22, but excluding BCMA.

1.123 “Juno Upstream Agreements” means those agreements listed in the applicable Data Package detailing the obligations of Juno to any Third Party with respect to a given offered Program, and any amendments thereof or successor agreements or agreements entered into pursuant to the terms of any such agreements.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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1.124 “Know-How” means all tangible and intangible: (a) information, techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, skill, experience, data, results (including pharmacological, toxicological and clinical test data and results, chemical structures, sequences, processes, formulae, techniques, research data, reports, standard operating procedures and batch records), analytical and quality control data, analytical methods (including applicable reference standards), full batch documentation, packaging records, release, stability, storage and shelf-life data, and manufacturing process information, results or descriptions, software and algorithms; and (b) compositions of matter, cells, cell lines, assays, animal models and any other physical, biological or chemical material, including physical embodiments of any Biologic Therapeutic, Small Molecule Compound or Engineered T-Cell, as applicable. As used in this definition, “clinical test data” shall include all information related to clinical or non-clinical testing, including patient report forms, investigators’ reports, biostatistical, pharmaco-economic and other related analyses, regulatory filings and communications, and the like.

1.125 “Law” or “Laws” means all laws, statutes, rules, regulations, orders, judgments, or ordinances having the effect of law of any national, multinational, federal, state, provincial, county, city or other political subdivision.

1.126 “Lead Development Candidate” means a Development Candidate in a Program for which IND Enabling Studies have been commenced.

1.127 “Licensed Product” means, with respect to a Licensed Program, any product that constitutes, incorporates, comprises or contains a Licensed Candidate arising under such Licensed Program, whether or not as the sole active ingredient, and in all forms, presentations, and formulations (including manner of delivery and dosage).

1.128 “Litigation Conditions” means, with respect to a Claim, (a) such Claim does not seek injunctive relief or non-monetary damages from the Indemnitee and (b) the Indemnitor expressly agrees in writing that as between the Indemnitor and Indemnitee, the Indemnitor shall be solely obligated to satisfy and discharge such Claim in full and is able to reasonably demonstrate that it has sufficient financial resources to meet such indemnification obligations.

1.129 “MAA” means a regulatory application filed with the EMA seeking Regulatory Approval of a biological, pharmaceutical or diagnostic product, and all amendments and supplements thereto filed with the EMA.

1.130 “Major EU Market Countries” means any of the following countries: [***].

1.131 “Manufacture” means all activities related to the manufacturing of a product or diagnostic product or, in either case, any component or ingredient thereof, including test method development and stability testing, formulation, process development, manufacturing scale-up whether before or after Regulatory Approval, manufacturing any product or diagnostic product in bulk or finished form for Development or Commercialization (as applicable), including filling and finishing, packaging, labeling, shipping and holding, in-process and finished product testing, release of a product or diagnostic product or, in either case, any component or ingredient thereof,

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

26


quality assurance and quality control activities related to manufacturing and release of a Product, and Regulatory Activities related to any of the foregoing. “ Manufacturing ” has a corresponding meaning.

1.132 “MHLW” means the Ministry of Health, Labour and Welfare of Japan, or the Pharmaceuticals and Medical Devices Agency of Japan, or any success or to either of them, as the case may be.

1.133 “NK Cells” means natural killer cells.

1.134 “New Drug Application” or “NDA” means a New Drug Application (as more fully described in U.S. 21 C.F.R. Parts 314.50 et seq. or its successor regulation) and all amendments and supplements thereto, submitted to the FDA, or any equivalent filing, including an MAA, in a country or regulatory jurisdiction other than the U.S. with the applicable Regulatory Authority, or any similar application or submission for Regulatory Approval filed with a Regulatory Authority to obtain marketing approval for a product containing a Small Molecule Compound or diagnostic product, in a country or in a group of countries.

1.135 “North America Territory” means the United States, Canada and Mexico, and their territories and possessions.

1.136 “Option” means a Celgene Option, or a Juno Option or [***], but excluding a BD Option.

1.137 “Option Exercise Notice” means a Celgene Option Exercise Notice or a Juno Option Exercise Notice, as applicable.

1.138 “Option Exercise Window” means the time period within which a Party may exercise its Option with respect to a Program [***] as follows:

(a) With respect to each Program, including any [***] Program and any [***] Program, but excluding (i) the CD19 Program (which shall be subject to Section 1.137(b), (ii) the CD22 Program, (which shall be subject to Section 1.137(c), and (iii) any [***] Program (which shall be subject to Section 2.2.1), for each Data Package Trigger Event for such Program, the period commencing upon the date upon which the relevant Data Package is provided to such Party and expiring upon the relevant Data Package Verification Date for such Program, with the Option Exercise Window with respect to the [***], as applicable, for each Program; provided however that with respect to the CD22 Program, only the [***] Option Exercise Window shall apply.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

27


(b) With respect to the CD19 Program, the Option Exercise Window shall commence upon the date upon which Celgene receives the Data Package for the CD19 Program and shall expire upon the Data Package Verification Date for the CD19 Program (“ CD19 Option Exercise Window ”).

(c) With respect to the CD22 Program, the Option Exercise Window shall commence upon (i) [***], or (ii) [***], and shall expire [***] following the corresponding Data Package Verification Date for the CD22 Program (each a “ CD22 Option Exercise Window ”). For clarity, if Juno [***], and Celgene does not exercise its Option for the CD22 Program [***], the CD22 Option Term shall expire, [***] for the CD22 Program, and the CD22 Program shall thereafter no longer be subject to the Collaboration or to Article 5.

1.139 “Option Term” means, on a Program-by-Program basis, any of the following, as applicable, subject to the extensions set forth in the definition of “Data Package Verification Date”:

(a) with respect to the CD19 Program, the period commencing upon the Original Execution Date and ending on the date that is the later of [***] after the Data Package Verification Date for the CD19 Program, or the date that is [***] after the Effective Date (the “ CD19 Option Term ”);

(b) with respect to the CD22 Program, subject to Section 1.137(c), the period commencing upon the Original Execution Date and ending on the expiration of the CD22 Option Exercise Window (the “ CD22 Option Term ”);

(c) with respect to each other Program, and subject to Section 3.2, the period commencing upon the Effective Date, and ending [***] following the Data Package Verification Date for the [***] Data Package with respect to each such Program;

and “ Option Terms ” means all of the foregoing. The Option Term for each Program shall terminate in any event upon the date on which the relevant Option or BD Option is exercised for such Program.

1.140 “Patent” means (a) all patents and patent applications in any country or supranational jurisdiction worldwide, (b) any substitutions, divisionals, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like of any such patents and patent applications, and (c) any foreign counterparts of any of the foregoing.

1.141 “Patient Sample” means tissue, fluid, or cells collected from a patient, or components of the foregoing.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

28


1.142 “Permitted Pre-Option Obligations” means activities performed or to be performed or rights granted or to be granted to a Third Party (a) under an agreement between a Party and a Third Party that are required under such agreement (where such agreement is not prohibited under Sections 3.1.6, 3.1.7, 5.1 and 5.2, and as such agreement is in effect as of the date of the exercise of the applicable Option (provided that such agreement was not entered into in any manner that fundamentally frustrates the purposes of this Agreement)), or (b) that are required under an agreement between X-BODY, Inc. or Juno Therapeutics GmbH (together, the “ Juno Subsidiaries ”), on the one hand, and a Third Party, on the other, that was entered into prior to the Original Execution Date, as such agreement exists as of the Original Execution Date (provided that such agreement was not entered into in any manner that fundamentally frustrates the purposes of this Agreement), including in each of (a) and (b) even if any activities performed under such agreements would violate or would cause a violation of Sections 3.1.6 or 3.1.7 or Article 5, if such Party or Juno Subsidiary does not have the ability to control the use of funds relating to, or to otherwise direct or control, any activities conducted by such Third Party in connection with such agreement.

1.143 “Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, governmental authority or agency, or any other entity not specifically listed herein.

1.144 “Phase 1a Clinical Trial” means a human clinical trial of a compound, the principal purpose of which is a preliminary determination of safety, pharmacokinetics, and pharmacodynamic parameters in healthy individuals or patients, as described in 21 C.F.R. 312.21(a), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

1.145 “Phase 1b Clinical Trial” means a human clinical trial of a compound, the principal purpose of which is a further determination of safety and pharmacokinetics of the compound whether or not in combination with concomitant treatment after an initial Phase 1a Clinical Trial, prior to commencement of Phase 2 Clinical Trials or Phase 3 Clinical Trials, and which provides (itself or together with other available data) sufficient evidence of safety to be included in filings for a Phase 2 Clinical Trial or a Phase 3 Clinical Trial with Regulatory Authorities, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country For studies of CAR/TCR agents, a Phase 1b Clinical Trial may include assessments of the expansion and persistence of the transferred T-Cells, immunological behavior of the transferred cells and evidence of clinical activity based on cellular, molecular and/or radiographic evidence of anti-tumor response.

1.146 “Phase 2 Clinical Trial” means a human clinical trial of a product in any country that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate evidence of clinical safety and effectiveness for a particular Indication or Indications in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

1.147 “Phase 3 Clinical Trial” means a human clinical trial of a product in any country that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(c) and is intended to (a)

 

29


establish that the product is safe and efficacious for its intended use, (b) define contraindications, warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (c) support Regulatory Approval for such product, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

1.148 “Phase 4 Clinical Trial” means a human clinical trial (other than a Phase 1 Clinical Trial, Phase 2 Clinical Trial or Phase 3 Clinical Trial) which is conducted on a product and after Regulatory Approval of the product has been obtained from an appropriate Regulatory Authority, and includes trials conducted voluntarily after Regulatory Approval for enhancing marketing or scientific knowledge of the product for an approved indication, or trials conducted after Regulatory Approval due to a request or requirement of a Regulatory Authority or as a condition of a previously granted Regulatory Approval.

1.149 “Pivotal Clinical Trial” means a human clinical trial of a product on a sufficient number of subjects that, prior to commencement of the trial, satisfies both of the following ((a) and (b)):

(a) such trial is designed to establish that such product has an acceptable safety and efficacy profile for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, or a similar clinical study prescribed by the U.S. or EMA; and

(b) such trial is a registration trial sufficient to support the filing of an application for a Regulatory Approval for such product in the U.S. or another country or some or all of an extra-national territory, as evidenced by (i) an agreement with or statement from the FDA or the EMA on a Special Protocol Assessment or equivalent, or (ii) other guidance or minutes issued by the FDA or EMA, for such registration trial.

1.150 “Post Option Costs” means, on a Designated Program-by-Designated Program basis, all [***] incurred in relation to [***] under such Designated Program after the exercise of an Option that are included in the calculation of Operating Profits & Losses pursuant to the terms of the Juno Lead Co-Co Agreement, or the Celgene Lead Co-Co Agreement, as applicable.

1.151 “Products” means (a) Celgene Products and (b) Juno Products.

1.152 “Product Liability” means any product liability claims asserted or filed by a Third Party (without regard to their merit or lack thereof), seeking Damages or equitable relief of any kind, relating to personal injury, wrongful death, medical expenses, an alleged need for medical monitoring, consumer fraud or other alleged economic losses, allegedly caused by any Co-Co Product (under a Co-Development and Co-Commercialization Agreement) or Licensed Product (under a License Agreement), and including claims by or on behalf of users (including spouses, family members and personal representatives of such users) of any Co-Co Product or Licensed Product (as applicable) relating to the use, sale, distribution or purchase of any Co-Co Product or Licensed Product (as applicable) sold by a Party, its Affiliates, sublicensees or distributors, including claims by Third Party payers, such as insurance carriers and unions.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

30


1.153 “Profit & Loss Share” means each Party’s share of Operating Profits and Losses pursuant to Section 5.2 of the Juno Lead Co-Co Agreement and/or the Celgene Lead Co-Co Agreement, as applicable.

1.154 “Program” means activities directed to the research, Development and Commercialization of [***] Agents (which, for example, may include [***]) directed (i) in the case of Programs other than [***], to a given Target or (ii) in the case of [***], to a given combination of two or more Immune Cell Targets. Programs include Celgene Programs, Juno Programs, [***] Programs, Designated Programs and BD Programs. A Program for which an Option or a BD Option has been exercised is deemed a “ Designated Program .”

1.155 “Prosecution and Maintenance” or “Prosecute and Maintain” means, with regard to a Patent, the preparation, filing, prosecution and maintenance of such Patent, as well as reissues, appeals, and requests for patent term adjustments (but not in connection with requests or applications for patent term extensions based on regulatory review periods for approved products, such as those provided in the United States under 35 U.S.C. § 156 and Supplementary Protection Certificates provided under the European Patent Convention, and similar extensions, where applicable, in other jurisdictions), and any appeal of a decision, holding or action in the course of any of the foregoing, with respect to such Patent, together with the initiation or defense of interferences, oppositions and other similar proceedings with respect to the particular Patent, and any appeals therefrom. For clarification, “Prosecution and Maintenance” or “Prosecute and Maintain” shall not include any other enforcement actions taken with respect to a Patent.

1.156 “Regulatory Approval” means the approval, license or authorization of the applicable Regulatory Authority necessary for the marketing and sale of a product for a particular Indication in a country in the world (including, with respect to each Major EU Market, separate pricing or reimbursement approvals whether or not legally required in order to sell the product in such country), and including the approval by the applicable Regulatory Authority of any expansion or modification of the label for such Indication.

1.157 “Regulatory Authority” means any national or supranational Governmental Authority, including the FDA in the U.S., the EMA in Europe and the MHLW in Japan, or any health regulatory authority in any country in the Territory that is a counterpart to the foregoing agencies and holds responsibility for development and commercialization of, and the granting of Regulatory Approval for, a Development Candidate, a Product or Diagnostic Product, as applicable, in such country.

1.158 “Regulatory Materials” means the regulatory registrations, applications, authorizations and approvals (including approvals of NDAs or BLAs, supplements and amendments, pre- and post-approvals, pricing and Third Party reimbursement approvals, and labeling approvals), Regulatory Approvals or other submissions made to or with any Regulatory Authority necessary for the research, Development (including the conduct of Clinical Trials), Manufacture, or Commercialization of a Development Candidate, Product, or Diagnostic Product

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

31


in a regulatory jurisdiction, together with all related correspondence to or from any Regulatory Authority and all documents referenced in the complete regulatory chronology for each NDA or BLA, including all Drug Master File(s) (if any), IND, CTA in the EU, MAA and supplemental new drug applications (sNDAs) or foreign equivalents of any of the foregoing.

1.159 “Reimbursable Costs” means, with respect to a Program, the following costs incurred by the Developing Party and its Affiliates in licensing or acquiring rights to, or carrying out research and Development activities for, such Program prior to the exercise of the Option for such Program:

(a) all (i) [***] costs [***] to such Program, including [***], and (ii) [***] incurred in relation to the [***] for such Program;

(b) all [***] costs, and all [***] costs [***] incurred in connection with (i) [***], and (ii) the [***], in each case to the extent [***] under such Program; and

(c) all [***] costs [***] with respect to [***] under such Program [***] in such Program,

in each case calculated in accordance with IFRS/GAAP.

1.160 “Research” means the performance of activities relating to Products or Development Candidates under this Agreement or any Development & Commercialization Agreement prior to commencement of IND Enabling Studies (or, for Diagnostic Products, commencement of IND Enabling Studies for the associated Product or Development Candidate), to identify, discover and characterize Development Candidates, Products and Diagnostic Products, or the equivalent of Development Candidates, Products and Diagnostic Products under the applicable Development & Commercialization Agreement.

1.161 “Research Collaboration Term” means the period of the Juno Scope Term, or such longer period as may be mutually agreed by the Parties.

1.162 “Resulting Patents” means collectively, Juno Resulting Patents, Celgene Resulting Patents and Joint Resulting Patents.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

32


1.163 “ROW Territory” means worldwide excluding (a) the North America Territory, and (b) solely with respect to Juno Cellular Therapy Products and Celgene Cellular Therapy Products, the China Territory.

1.164 “Small Molecule Compound” means any molecule or molecular structure that [***]. For clarity, a “Small Molecule Compound” is not a Biologic Therapeutic, and vice versa.

1.165 “Specific Agent” means, with respect to a particular Target, [***].

1.166 “Specifically Directed” means, with respect to a Target, [***].

1.167 “Sublicensee” means, with respect to a Party, a Third Party to whom such Party has granted a license under Know-How or Patents Controlled by the other Party, or a sublicense under Know-How or Patents licensed to such Party pursuant to a Development & Commercialization Agreement to Develop, Manufacture, have Manufactured, use, offer for sale, sell, import and otherwise Commercialize Development Candidates, or Products in the Field worldwide or in a particular territory or field, in accordance with the applicable Development & Commercialization Agreement, but excluding any Third Party acting solely as a distributor and excluding the other Party, its Affiliates, sublicensees and other licensees to the extent such sublicense or license is received from the other Party.

1.168 “Target” means a [***]. For example, with respect to CD19, a “Target” includes [***]. Unless otherwise specified, [***], a Target encompasses [***]. Where specified, [***]. Following the exercise of the Option for a Juno Program or a Celgene Program, as applicable, a Target will become a “ Licensed Target ”, if the Parties enter into a License Agreement, and a “ Co-Co Target ”, if the Parties enter into a Juno Lead Co-Co Agreement or a Celgene Lead Co-Co Agreement, as applicable.

1.169 “T-Cell” means a T-lymphocyte.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

33


1.170 “TCR” means a T-Cell receptor or antigen-binding fragment thereof that confers the ability of the T-Cell to recognize and bind to any protein of interest or a peptide epitope thereof when complexed with an MHC (major histocompatibility complex) molecule. A TCR may be a naturally-occurring T-Cell receptor or fragment thereof and/or a recombinant T-Cell receptor or fragment thereof.

1.171 “TCR T-Cell” means a T-Cell that expresses one or more TCRs on the surface of such cell.

1.172 “Territory” means worldwide.

1.173 “Third Party” means any Person other than Juno or Celgene that is not an Affiliate of Juno or of Celgene.

1.174 “United States” or “U.S.” means the United States of America and all of its territories and possessions.

1.175 “[***] BD Program” means activities conducted by a Third Party directed to Research, Development and/or Commercialization of [***] Program, in which [***] to the Target of such [***] Program with respect to which rights [***], including by way of [***]. For clarity a Program that is [***] BD Program if at the time such [***] occurs (a) there is a [***] Program [***] and (b) [***] Program are within an [***] of such [***] Program.

1.176 “[***] Program” means (a) activities conducted [***] by a Party and/or its Affiliates directed to Research, Development and/or Commercialization of [***] Program, in which the [***] to the Target of such [***] Program, where at least one such [***]. For clarity, Programs [***] in which [***] directed to Research, Development and/or Commercialization of [***], and where [***] has been [***] at the time such Party [***] only upon the [***] for such Program, and shall thereafter be subject to the [***] Section 3.1.5.

1.177 “[***] Program” means an [***] Program or an [***] BD Program.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

34


1.178 “[***] Celgene Background Patents” means Patents Covering [***] to the extent not included in the Celgene Patents.

1.179 “[***] Juno Background Patents” means Patents Covering [***] to the extent not included in the Juno Patents.

1.180 “Upfront Payment” means any consideration paid by the Offering Party within the first [***] following the effective date of the agreement pursuant to which the Offering Party acquired a license or other rights to the relevant Program, [***], as described in Section 2.2.1, excluding any amounts paid by the Offering Party that are [***] attributable to amounts paid by the Offering Party as the purchase price for [***], for such [***] equity securities (including [***]) of the Third Party. It being understood and agreed that [***] shall be included in the Upfront Payment.

1.181 “Vaccine” means any substance used to stimulate the production of Antibodies or other adaptive immune system-derived effect in vivo to provide immunity against one or several diseases, which is prepared from the causative agent of a disease, its products, or a synthetic substitute, and designed to act as an antigen without inducing the disease.

1.182 “Valid Claim” means a claim of (a) an issued patent in the U.S. or in a jurisdiction outside the U.S., as applicable, that has not expired, lapsed, been cancelled or abandoned, or been dedicated to the public, disclaimed, or held unenforceable, invalid, revoked or cancelled by a court or administrative agency of competent jurisdiction in an order or decision from which no appeal has been or can be taken, including through opposition, reexamination, reissue or disclaimer; or (b) a pending patent application that has not been finally abandoned, or expired and which has been pending for no more than [***] from the date of filing of the earliest patent application to which such pending patent application is entitled to claim priority.

1.183 “[***] Juno Products” means a Juno Development Candidate [***]. For clarity, [***] is not a [***] Juno Product.

1.184 Additional Definitions . Each of the following terms has the meaning described in the corresponding section of this Agreement indicated below:

 

Definition:

   Section:

AAA

   12.8.1

[***]

   5.3.1

Acquirer Program

   5.3.3(c)

[***]

   1.93

Additional Amounts

   1.57

Agreement

   Preamble

Alliance Manager

   4.1.3

[***]

   2.2.1(c)

Antitrust Clearance Date

   3.2.2

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

35


Definition:

   Section:

Arbitration Eligible Dispute

   12.8.1

Arbitration Issue

   12.8.1(a)

Arbitration Notice

   12.8.1(a)

Assignee Party

   7.2.7

Assignor Party

   7.2.7

Bankruptcy Code

   7.1.7

[***]

   5.1.1(d)(iv)

BD Acquiring Party

   2.2.1(a)

BD Evaluating Party

   2.2.1(a)

BD Evaluation Period

   2.2.1(a)

BD Opt-In Payment

   2.2.1(c)

BD Option

   2.2.1(a)

BD Option Exercise Notice

   2.2.1(a)

[***]

   2.2.1(b)

BD Technology

   2.2.2

[***]

   1.16

[***]

   5.1.1(e)

[***] BD Program

   1.73

[***] Program

   2.2.1(e)

[***] Product

   5.1.1(a)

CD19 Development Candidates

   1.109(a)

CD19 Option Exercise Window

   1.138(b)

CD19 Option Term

   1.139(a)

CD22 Development Candidates

   1.109(b)

CD22 Option Exercise Window

   1.138(c)

CD22 Option Term

   1.139(b)

Celgene

   Preamble

[***]

   7.1.2(c)

Celgene Cellular Therapy Product

   1.40

Celgene Co-Promote Program

   3.1.4(a)

Celgene Co-Promote Right

   3.1.4(a)

Celgene Component

   5.1.2(b)

Celgene Corp.

   Preamble

Celgene In Vivo Product

   1.105

Celgene Indemnitees

   10.2

[***]

   9.4.1(e)(ii)

Celgene Lead Co-Co Agreement

   1.68

[***]

   9.4.1(e)(ii)

[***]

   9.4.1(e)(ii)

Celgene Option

   3.1.1

Celgene Option Exercise Notice

   3.1.3(c)

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

36


Definition:

   Section:

[***]

   5.1.2(d)

Celgene Program Assets

   3.1.7

Celgene Reagent

   5.1.2(b)

[***] BD Program

   1.73

[***]

   2.2.1(e)

[***]

   1.35

Celgene Reversion Compounds

   11.9.1

Celgene RIVOT

   Preamble

Celgene Upstream Agreement Patents

   7.3.7(b)

[***]

   7.2.5

[***]

   7.2.5

[***]

   11.5

CMC Activities

   1.41

Co-Co Agreement

   9.4.1(e)(iii)

Co-Co Candidate

   1.24, 1.109

Co-Co Target

   1.168

Collaboration

   2.1

Collaboration Committees

   4.1.1(a)

Collaboration Material Transfer Agreement

   2.8.1

[***]

   3.1.5(a)

Commercialization Lead Party

   4.2.4(b)

Commercialize

   1.50

Competitive Program

   5.3.2

Competitive Program Party

   5.3.2

Core Countries

   7.3.6

CTA

   1.100

Cure Period

   11.2.1

Data Package Party

   1.63

Data Package Trigger Event

   1.62

Defend

   1.64

Designated Program

   1.154, 3.1.3(d)

Designating Party

   3.1.3(d)

Designation Payment

   6.4.1

Develop

   1.66

Development Lead Party

   2.3.2(a)

[***]

   3.1.4(e)

Disclosing Party

   8.1

[***] BD Program

   1.73

DOJ

   3.2.2

Electronic Delivery

   12.11

[***]

   5.2.1

Existing Confidentiality Agreement

   8.8

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

37


Definition:

   Section:

Expert

   12.8.1(b)

[***]

   9.4.1(e)(iv)

Force Majeure

   12.3

FTC

   3.2.2

GAAP

   1.1

HSR Act

   1.6

HSR/Antitrust Filing

   3.2.2

IFRS

   1.1

[***]

   3.1.3(a)

[***]

   1.95

[***]

   1.96

[***]

   1.96

Implementing Agreements

   3.2.1

Implementation Date

   3.2.2

[***]

   1.61(b)

[***]

   1.138(a)

Indemnification Claim

   10.3

Indemnitee

   10.3

Indemnitor

   10.3

[***]

   6.7.1(a)

JBDC

   4.1.1(a)

JCC

   4.1.1(a)

JMC

   4.1.1(a)

Joint Collaboration IP

   7.2.3

Joint Collaboration Patents

   7.3.2(a)

JRDC

   4.1.1(a)

JSC

   4.1.1(a)

Juno

   Preamble

[***]

   7.1.1(b)

Juno Cellular Therapy Product

   1.40

Juno In Vivo Product

   1.105

Juno Indemnitees

   10.1

[***]

   9.4.1(e)(i)

Juno Lead Co-Co Agreement

   1.68

[***]

   9.4.1(e)(i)

[***]

   9.4.1(e)(i)

Juno Option

   3.1.2

Juno Option Exercise Notice

   3.1.3(c)

[***] BD Program

   1.73

[***]

   5.1.1(e)

Juno Program Assets

   3.1.6

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

38


Definition:

   Section:

Juno Reversion Compounds

   11.8.1

Juno Subsidiaries

   1.142

Juno Upstream Agreement Patents

   7.3.7(a)

Licensed Candidates

   1.109

Licensed Program

   1.117(c)

Licensed Target

   1.168

Manufacturing

   1.128

Manufacturing Agreement

   2.10

Manufacturing Plans

   4.4.3

[***]

   2.10.1(c)

[***]

   2.10.1(c)

Material Receiving Party

   2.8.1

Materials

   2.8.1

Maximum Number of Co-Promote Rights

   3.1.4(d)

[***]

   1.93

[***]

   1.94

Negotiation Period

   5.5

New Committee

   4.1.1(a)

New Prosecution Patent

   7.3.6

[***]

   1.62(a)

[***]

   1.138(a)

Notice of Interest

   5.5

Notice of Interest Period

   5.5

Offering Party

   3.1.3(d)

Option Extending Party

   3.1.8(a)

Original Execution Date

   Preamble

Other Actives

   1.49

Other Juno Programs

   3.1.1(c)

Party or Parties

   Preamble

Patent Committee

   4.1.1(a)

Patent Liaison

   4.1.4

Patent Strategy

   4.7.6(c)

Payee Party

   6.7.1(a)

Paying Party

   6.7.1(a)

Pharmacovigilance Agreement

   2.4.1

[***]

   1.62(c)

[***]

   1.138(a)

[***]

   1.62(d)

[***]

   1.138(a)

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

39


Definition:

   Section:

[***]

   3.1.5(a)

[***] Notice

   3.1.3(e)

Proposed Resolution

   12.8.1(c)

Prosecuting Party

   11.5

Publishing Party

   8.7.1

Purpose

   2.8.1

[***]

   2.2.1(c)

Receiving Party

   8.1

Regulatory Activities

   2.3.3(a)

Regulatory Lead Party

   2.3.3(a)

Research Term Expiration

   3.1.8

[***]

   8.2.2

[***]

   5.5

[***] Expiration

   5.5

[***] Term

   5.5

ROW Manufacturing Facilities

   2.10.1(b)

SEC

   8.3.1(a)

Securities Regulators

   8.5

Selected Party

   7.3.2(a)

[***]

   12.8.2(a)

Subcommittee

   4.1.1(b)

[***]

   6.7.2

[***]

   5.1.1(e)

Term

   11.1

Third Party License

   7.9.3

[***]

   5.5

Transferring Party

   2.8.1

[***] BD Opt-In Payment

   6.5.3

[***]

   6.5.3

[***] Data Package

   3.1.5(c)(2)

[***] Option Exercise Notice

   3.1.5(d)

[***]

   3.1.3(a)

Voting and Standstill Agreement

   11.6

[***] Product

   5.1.2(b)

ARTICLE 2

COLLABORATION AND DEVELOPMENT

2.1 Scope and Collaboration Overview . Pursuant to this Agreement and as further provided in this Article 2, during the Research Collaboration Term, Juno and Celgene shall (a) conduct the Juno Programs and the Celgene Programs, [***], respectively, with the intention of identifying and Developing Development Candidates arising from such Juno Programs or

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

40


Celgene Programs, and offer such Programs to the other Party in accordance with Section 3.1.3, (b) evaluate and offer to the other Party Eligible BD Programs [***] in accordance with Section 2.2.1 and 3.1.5 respectively, and (c) evaluate and discuss BD Technology. The foregoing activities, as well as activities conducted pursuant to the Development & Commercialization Agreements, together, shall be the “ Collaboration ”.

2.1.1. Juno Responsibility . Commencing on the Effective Date, on a Juno Program-by-Juno Program basis during the Research Collaboration Term, until the earlier of (a) the exercise by Celgene of the Option with respect to a Juno Program, or (b) the expiration of the Option Term for such Juno Program, Juno may, in its discretion, conduct research and Development activities under the Juno Programs with the goal of identifying Juno Development Candidates and thereafter Developing and progressing such Juno Development Candidates [***]. At specified points following the [***] such Juno Program, Celgene shall have the right to exercise its Option to participate in the further Development and Commercialization of such [***], as further set forth in Section 3.1.1 and 3.1.3, and in the applicable Development & Commercialization Agreement.

2.1.2. Celgene Responsibility . Commencing on the Effective Date, on a Celgene Program-by-Celgene Program basis during the Research Collaboration Term, until the earlier of (a) the exercise by Juno of the Option with respect to a Celgene Program, or (b) the expiration of the Option for such Celgene Program, Celgene will, in its discretion, conduct research and Development activities under the Celgene Programs with the goal of identifying lead Celgene Development Candidates and thereafter Developing and progressing such lead Celgene Development Candidates [***]. At specified points following the identification of a Celgene Development Candidate in each such Celgene Program, Juno shall have the right to exercise its Option to participate in the further Development and Commercialization of such Celgene Development Candidate, as further set forth in Sections 3.1.2 and 3.1.3, and in the applicable Development & Commercialization Agreement.

2.1.3. Conduct of Programs Prior to Option Exercise . Each Party shall have sole discretion regarding which Programs it selects to progress during the Research Collaboration Term, and the research and Development activities performed thereunder. Each Juno Program undertaken by Juno, and each Celgene Program undertaken by Celgene, shall be included in the Collaboration except as provided in Section 2.1.4. Each Party may decide to cease activities under any Program it conducts prior to the exercise of the Option by the other Party at any time.

2.1.4. Excluded Programs . The Celgene Excluded Programs shall not be part of the Collaboration (including for purposes of Section 3.1.5) and shall not be subject to Juno’s rights under this Agreement or any Development & Commercialization Agreement.

2.1.5. China Territory . Celgene acknowledges that Juno [***] in the China Territory, [***] in the China Territory. Accordingly, while the Parties intend for the Collaboration to operate in general on a worldwide basis, they have excluded from the scope of the Collaboration activities with respect to the Development, Manufacture and Commercialization of Cellular Therapy Products in the China Territory. [***] for the Development, Manufacture and Commercialization of Cellular Therapy Products for sale in the China Territory.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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2.2 Business Development Activities.

2.2.1. BD Programs . During the Research Collaboration Term, either Party or its Affiliates may identify certain opportunities to in-license or acquire rights in Programs owned or Controlled by Third Parties that are within the Juno Scope or the Celgene Scope, including Eligible BD Programs and [***]. This Section 2.2.1 shall apply solely to the in-license or acquisition of rights in Eligible BD Programs where at the time of acquisition of rights or license thereto by a Party, [***] Eligible BD Program. Where [***], and a Party licenses or acquires rights in a BD Program that [***] the Designated Program, such BD Program shall be [***] and each Party’s rights and obligations with respect to such [***]. The following provisions will apply to Eligible BD Programs:

(a) During the Research Collaboration Term, subject to Section 2.2.1(b) with respect to [***] BD Programs, if either Party or its Affiliates (i) licenses or acquires rights (other than by way of an option to acquire rights in a Program, before such Program becomes a Celgene [***] Program or a Juno [***] Program) to an Eligible BD Program pursuant to an agreement with a Third Party entered into after the Effective Date, or (ii) exercises an option to license or acquire rights in an Eligible BD Program under an agreement with a Third Party entered into after the Effective Date with respect to a Celgene [***] Program or a Juno [***] Program (the Party entering into such license, acquiring such rights or exercising such option, the “ BD Acquiring Party ”), the BD Acquiring Party shall provide to the other Party (the “ BD Evaluating Party ”), within [***] following the licensing or acquisition of such rights or exercise of such option, through the JBDC, [***] such Eligible BD Program as is [***] such BD Evaluating Party to decide whether it wishes to exercise an option (the “ BD Option ”) to include such Eligible BD Program within the scope of the Collaboration. Such offer to the BD Evaluating Party shall be subject to reasonable confidentiality restrictions and the terms of the agreement between the BD Acquiring Party and the Third Party from which the rights in such Eligible BD Program were licensed or acquired. The BD Evaluating Party shall have [***] after the BD Evaluating Party receives such information (or such longer period as the Parties may mutually agree in writing) (such [***] or longer period, the “ BD Evaluation Period ”), in which to consider such Eligible BD Program. The BD Evaluating Party may, during the BD Evaluation Period, provide written notice to the BD Acquiring Party that the BD Evaluating Party desires to exercise its Option to include such Eligible BD Program within the Collaboration, such notice [***] the BD Evaluating Party is [***] such Eligible BD Program as a BD Designated Program (a “ BD Option Exercise Notice ”). During such BD Evaluation Period, the BD Acquiring Party will provide any additional information Controlled by the BD Acquiring Party that may be reasonably requested by the BD Evaluating Party in order to assist such BD Evaluating Party in determining whether to exercise its Option for such Eligible BD Program. If at the time a Party licenses or acquires rights to (other than by way of an option to acquire rights in a Celgene [***] Program or Juno [***] Program) with respect to one or more [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

42


[***] Agent from a Third Party [***], such Program [***] an Eligible BD Program and (i) in the case of a Program licensed or acquired by Juno, shall be deemed a Juno Program (pursuant to Section 1.117(a)), and (ii) in the case of a Program licensed or acquired by Celgene, shall be deemed a Celgene Program.

Notwithstanding anything to the contrary, on [***] within each Program under this Section 2.2, if pursuant to Sections 5.1.1(d)(i), 5.1.2, 5.1.3 or 5.2.2 either Party’s [***], then neither Party would thereafter [***].

(b) Notwithstanding the foregoing paragraph, if a [***] BD Program contains any product (i) that is [***] or (ii) for which a [***], then the Party to whom such [***] BD Program is being offered shall not have a right to exercise a BD Option to [***].

(c) If the BD Evaluating Party delivers a BD Option Exercise Notice to the BD Acquiring Party within the BD Evaluation Period for a given Eligible BD Program, which thereby becomes a BD Designated Program, then within the later of [***] following the delivery of such BD Option Exercise Notice or Antitrust Clearance Date, the BD Evaluating Party shall also pay to the BD Acquiring Party, as partial consideration for the rights granted to the BD Evaluating Party in relation to such BD Designated Program a lump sum payment equal to [***] in relation to such BD Designated Program prior to such date (the “ BD Opt-In Payment ”), except, where the BD Acquiring Party is [***]. For the purposes of calculating [***], it is understood and agreed that if [***] include any [***] then the Parties shall [***] for which a Party is seeking to exercise an Option [***] for a period of [***]. In the event the Parties [***] as promptly as practicable [***]. The BD Evaluating Party shall notify the BD Acquiring Party in writing within [***] following [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

43


[***], whether the BD Evaluating Party wishes to exercise its Option for such Eligible BD Program. For clarity, the BD Evaluating Party shall have no obligation to proceed to exercise its Option with respect to any Eligible BD Program [***]. The following shall apply to and following the payment of the BD Opt-In Payment:

(i) with respect to any BD Designated Program that is a [***] BD Program, the BD Opt-In Payment, if applicable, shall be paid by the BD Evaluating Party as set forth in this Section 2.2.1(c) above, and the Parties shall simultaneously with such payment enter into (A) except for a [***] Program [***], a [***] Lead Co-Co Agreement, and (B) for a [***] BD Program [***], a [***] Lead Co-Co Agreement. Upon the exercise of a BD Option by a Party for an Eligible BD Program under this Section 2.2.1, the Parties will update Exhibit B of the applicable Development & Commercialization Agreement [***] for such BD Designated Program.

(ii) with respect to any Eligible BD Program that is a [***] BD Program for which [***] wishes to exercise the BD Option, (A) the Parties shall [***] following the delivery of the BD Option Exercise Notice, the [***] such Eligible BD Program. [***].

(iii) with respect to any BD Designated Program that is a [***] BD Program, the BD Opt-In Payment if applicable, shall be paid by Juno as set forth in this Section 2.2.1(c) above, and the Parties shall simultaneously with such payment enter into: (A) a [***] Lead Co-Co Agreement, [***] BD Program, and (B) if the [***] BD Designated Program include Programs [***], then the Parties shall enter into (x) a Celgene Lead Co-Co Agreement [***] BD Program, and (y) a Celgene Lead Co-Co Agreement [***]. In such case, the Parties will [***] BD Designated Program.

(d) Notwithstanding the foregoing subsections (a) through (c), neither Party shall be required to offer any Eligible BD Program to the other Party pursuant to Section 2.2.1(a)

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

44


for exercise of a BD Option if such offer would require the BD Acquiring Party to breach its agreement with the Third Party from which it in-licensed or acquired such rights for such Eligible BD Program; [***] such Eligible BD Program pursuant to this Section 2.2.1, or (ii) [***] pursuant to this Section 2.2.1, the [***] by (A) with respect to a [***] Program, [***], (B) with respect to a [***] Program [***] in accordance with the [***], or (C) with respect to a [***] Program, [***], provided that with respect to (A) and (C) if [***] under such Eligible BD Programs, then at [***] request, [***] shall [***] in (A) and (C)).

(e) If the BD Evaluating Party decides not to exercise its BD Option with respect to an Eligible BD Program that is a [***] or a [***] BD Program within the BD Evaluation Period, then such [***] BD Program [***] and such [***] BD Program [***], upon the effective date of such BD Acquiring Party’s agreement with such Third Party. Thereafter, [***], with respect thereto as provided in [***], including [***] each such [***] Program [***] ([***] in the case of a [***] Program) for [***] for such [***] Program or [***] Program, as applicable. If the BD Evaluating Party has not exercised its BD Option with respect to an Eligible BD Program, and the [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

45


[***] , then, solely with respect to the [***] such Eligible BD Program shall no longer be subject to the other Party’s BD Option with respect thereto pursuant to Section 3.1, and the BD Acquiring Party shall no longer be required to [***] such Eligible BD Program to the other Party for exercise of the Option following the date of expiration of the BD Evaluation Period and [***] such Eligible BD Program [***]. Upon exercise by a Party of an Option for a [***] Program, or by [***] for a [***] Program, the payments for exercise of the Option set forth in Section 6.4.2(b) shall apply as if such Program was a Juno Program or a Celgene Program, as applicable. With respect to any other Eligible BD Program that is [***] Program or [***] Program for which the BD Evaluating Party does not exercise a BD Option, such Eligible BD Program, the [***] Agents, and [***] such Eligible BD Program will not be included within the Collaboration and the provisions of Article 5 shall not apply to such Eligible BD Program, [***].

2.2.2. BD Technology . If during the Research Collaboration Term either Party identifies any intellectual property or Know-How Controlled by a Third Party that is not included in the Juno IP, Juno Background IP, Celgene IP (solely during the Research Collaboration Term) or Celgene Background IP (solely during the Research Collaboration Term), and that would, if Controlled by a Party, [***], as applicable, excluding Know-How that is [***] (“ BD Technology ”), or a Party in-licenses or acquires rights to BD Technology during the Research Collaboration Term, such Party shall, except to the extent it is restricted from doing so pursuant to its agreements with Third Parties, use reasonable efforts to notify the JBDC of such BD Technology and provide information in such Party’s Control that is reasonably useful to evaluate such BD Technology for use in the Collaboration. The JBDC shall discuss and consider whether such BD Technology would be useful for the conduct of the Juno Programs or the Celgene Programs. Subject to any restrictions in Article 5, each Party shall have the right to in-license or acquire rights to BD Technology at any time, without an obligation to first consult with the JBDC under this Section 2.2.2 with respect thereto.

2.3 Development and Regulatory Responsibilities.

2.3.1. Pre-Option Exercise . During the Research Collaboration Term prior to the exercise of the Option:

(a) by Celgene for any Juno Program, on a Juno Program-by-Juno Program basis, and at Juno’s expense (i) Juno may conduct research and Development activities under a Juno Program at its sole discretion with the aim of achieving the goals described in Section 2.1.1 with respect to each Juno Program, and (ii) Juno shall be responsible for preparing and filing all Regulatory Materials for, and for obtaining and maintaining all Regulatory Approvals relating to, Juno Development Candidates and/or Juno Products arising therefrom; and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

46


(b) by Juno for any Celgene Program, on a Celgene Program-by-Celgene Program basis, and at Celgene’s expense (i) Celgene may conduct research and Development activities under a Celgene Program at its sole discretion with the aim of achieving the goals described in Section 2.1.2 with respect to each Celgene Program, and (ii) Celgene shall be responsible for preparing and filing all Regulatory Materials for, and for obtaining and maintaining all Regulatory Approvals relating to, Celgene Development Candidates and/or Celgene Products arising therefrom.

2.3.2. Development Post-Option Exercise . Following the exercise of the Option, or the BD Option, as applicable, and subject to the terms of any applicable Development & Commercialization Agreement:

(a) by Celgene for any Juno Program [***], Juno shall be the lead party for all Development activities (the “ Development Lead Party ”) conducted under such Juno Programs [***] with respect to the Juno Development Candidates arising in such Juno Program in the North America Territory, and Celgene shall be the Development Lead Party and Commercialization Lead Party in the ROW Territory for all Development activities conducted under such Juno Programs [***] with respect to the Juno Development Candidates arising in such Juno Program;

(b) by Juno for any Celgene Program [***], Celgene shall be the Development Lead Party and Commercialization Lead Party in the ROW Territory and the North America Territory for all Development activities conducted under such Celgene Programs [***] with respect to the Celgene Development Candidates arising in such Celgene Program;

(c) by either Party with respect to any Eligible BD Program [***] that is a [***] Juno shall be the Development Lead Party and Commercialization Lead Party with respect to such [***] BD Program in the North America Territory and Celgene shall be the Development Lead Party and Commercialization Lead Party with respect to such [***] BD Program in the ROW Territory;

(d) by Celgene for any [***] BD Program, [***], Celgene shall be the Development Lead Party and Commercialization Lead Party for such BD Designated Program in the ROW Territory and the North America Territory, and [***], then Juno shall be the Development Lead Party and Commercialization Lead Party in the ROW Territory and the North America Territory for such BD Designated Program, unless the Parties mutually agree otherwise in writing; and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

47


(e) by Juno with respect to any [***] BD Program, then (i) [***], then Celgene shall be the Development Lead Party and the Commercialization Lead Party in the ROW Territory and the North America Territory for such BD Designated Program, unless the Parties mutually agree otherwise in writing.

2.3.3. Regulatory Filings and Activities Post-Option Exercise .

(a) Following Celgene’s exercise of the Option for a Juno Program, or a BD Option for a BD Program for which Juno was the BD Acquiring Party, other than a BD Program for which [***], and subject to the terms of any applicable Development & Commercialization Agreement: (i) Juno shall be the lead party for the conduct of all activities directed to obtaining Regulatory Approval (including the preparation and filing of all Regulatory Materials) (the “ Regulatory Lead Party ”, and such activities the “ Regulatory Activities ”) for Juno Development Candidates and Juno Products arising from such Juno Program in the North America Territory, and shall be the holder of all such Regulatory Approvals, and (ii) Celgene shall be the Regulatory Lead Party for the conduct of all Regulatory Activities for Juno Development Candidates and Juno Products arising from such Juno Programs in the ROW Territory, and shall be the holder of all such Regulatory Approvals.

(b) Following Juno’s exercise of its BD Option for an Eligible BD Program [***], and subject to the terms of any applicable Development & Commercialization Agreement, Celgene shall be the Regulatory Lead Party for the Regulatory Activities for Celgene Development Candidates and Celgene Products arising from such Celgene Program in the ROW Territory and in the North America Territory, and shall be the holder of all such Regulatory Materials and Regulatory Approvals.

(c) For any BD Designated Program [***], Celgene shall be the Regulatory Lead Party in both the North America Territory and ROW Territory. For any BD Designated Program [***], Juno shall be the Regulatory Lead Party in the North America Territory, and Celgene shall be the Regulatory Lead Party in the ROW Territory.

(d) Notwithstanding the foregoing subsections (a), (b) and (c), in each case, the Regulatory Lead Party shall provide the other Party with a reasonable opportunity to substantively comment on all material filings and communications with any Regulatory Authorities in the Regulatory Lead Party’s territory, and shall permit such other Party to attend meetings with Regulatory Authorities to the extent reasonably practical. The Regulatory Lead Party will in good faith consider any comments by and actions recommended by the other Party; provided however that the Regulatory Lead Party will do so promptly and consistent with any applicable filing deadlines.

2.3.4. Right of Reference .

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

48


(a) Each Party shall have access and a right of reference to all data contained or referenced in any Regulatory Materials Controlled by the other Party that is [***] a Celgene Program, a Juno Program and any Designated Program (including any Regulatory Approvals) necessary for the research, Development, Manufacture or Commercialization of Juno Development Candidates and Juno Products, or Celgene Development Candidates and Celgene Products (and in each case, related Diagnostic Products), as applicable and as may be reasonably necessary to enable each Party to perform its obligations hereunder and in the applicable Development & Commercialization Agreement (if executed, and as set forth therein).

(b) Juno shall have access and a right of reference to all data contained or referenced in any Regulatory Materials Controlled by Celgene specifically related to a Celgene Program, a Juno Program or any Designated Program (including any Regulatory Approvals) necessary for the research, Development, Manufacture or Commercialization of Cellular Therapy Development Candidates and Cellular Therapy Products (and in each case, related Diagnostic Products), as applicable and as may be reasonably necessary to enable Juno to research, Develop, Manufacture or Commercialize Cellular Therapy Development Candidates and Cellular Therapy Products in the China Territory.

2.4 Safety Information.

2.4.1. Pharmacovigilance Agreement . With respect to all Programs, the Development Lead Party therefor shall inform the other Party during the Research Collaboration Term prior to expiration of the applicable Option Term for such Program of the side effect profiles for Development Candidates in such Program, including pregnancy and suspected pregnancy, Damages, toxicity or sensitivity reactions associated with the use of any Development Candidate, regardless of whether these effects are attributable to such Development Candidate. The Parties shall work together in good faith to develop pharmacovigilance communication procedures to facilitate the exchange of such information and set them forth in a separate pharmacovigilance agreement between Juno and Celgene (or an Affiliate of either Party, as designated by such Party) (“ Pharmacovigilance Agreement ”). Each Development Lead Party shall have the right to take any reasonable action, including the right to [***] of such Development Candidate, if there are [***].

2.4.2. Communication . Each Party shall cooperate with the other Party and share information concerning the pharmaceutical safety of each Development Candidate. Each Party shall: (i) promptly advise the other Party of [***] of such Development Candidate and any actions taken in response to such information; (ii) promptly advise the other Party of [***] of such Development Candidate [***], as far as this concerns [***]; and (iii) timely provide the other Party with [***] such Development Candidate of which [***], as far as this relates to [***]. Treatment of safety information, standard operating procedures and training, as well as a statement of respective regulatory obligations shall be agreed in the Pharmacovigilance Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

49


2.5 Reports; Results; Testing by the Parties . Each Party shall maintain complete, current and accurate records of all research and Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the research and Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials for Programs in formal written study records according to applicable Laws, including national and international guidelines such as ICH, GCP, GLP and GMP. Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times, as reasonably requested by a Party. Each Party shall provide the other Party written progress reports on the status of its activities under each Program during the Research Collaboration Term as set forth below, or, following the exercise of the Option for a given Program, as set forth in the applicable Development & Commercialization Agreement, including (a) the identification of any [***], and (b) summaries of data associated with each Party’s activities with respect to its respective scope, such reports to be provided at least [***] in advance of each JSC meeting, with respect to matters that are within the purview of the JSC.

2.6 No Representation . Neither Party makes any representation, warranty or guarantee that the Collaboration will be successful, or that any other particular results will be achieved with respect to the Collaboration, any Program, any Target, Celgene Target, Juno Target, any [***] any Development Candidate, or any Product hereunder.

2.7 Subcontracting.

2.7.1. Generally . Subject to the terms of this Agreement or any Development & Commercialization Agreement, as applicable, each Party shall have the right to engage Affiliates or Third Party subcontractors to perform certain of its obligations under this Agreement or any Development & Commercialization Agreement, as applicable. Any such Affiliate or subcontractor shall meet the qualifications typically required by such Party for the performance of work similar in scope and complexity to the subcontracted activity and perform such work consistent with the terms of this Agreement or any Development & Commercialization Agreement, as applicable; provided however that any Party engaging an Affiliate or subcontractor hereunder shall remain fully responsible and obligated for such activities. The foregoing requirements of this Section 2.7.1 shall not apply with respect to [***]. For clarity, this Section 2.7.1 does not apply to academic collaborators, who are subject to Section 5.3.1.

2.7.2. [***]. Each Party shall have the right to [***], which shall include [***] as reasonably requested by the requesting Party [***]. Such [***]. Each Party shall [***]. If a Party cannot [***].

2.8 Material Transfer.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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2.8.1. Transfer . On a Program-by-Program basis, commencing on the Effective Date until expiration of the applicable Option Term, either Party (the “ Transferring Party ”) shall transfer, if specified in a Development Plan, or if such Party otherwise agrees in writing to make such transfer (such agreement not to be unreasonably withheld) upon reasonable request by the other Party (the “ Material Receiving Party ”), certain [***] (the “ Materials ”) for use by the Material Receiving Party in furtherance of its rights and the conduct of its obligations under this Agreement, as mutually agreed by the Parties and set forth in the relevant material transfer agreement (the “ Purpose ”). All transfers of such Materials by the Transferring Party to the Material Receiving Party shall be documented in a material transfer agreement substantially in the form of Exhibit D , which sets forth the type and name of the Material transferred, the amount of the Material transferred, the date of the transfer of such Material and the Purpose (each, a “ Collaboration Material Transfer Agreement ”). The Parties agree that the exchanged Materials shall be used in compliance with applicable Law and the terms and conditions of this Agreement, and shall not be reverse engineered or chemically analyzed, except if provided for in the applicable Development Plan or as required for verification purposes (if needed).

2.8.2. License; Ownership . At the time the Transferring Party provides Materials to the Material Receiving Party as provided herein and to the extent not separately licensed under this Agreement, the Transferring Party hereby grants to the other Party a non-exclusive license under the Patents and Know-How Controlled by it to use such Materials solely for the Purpose, and such license, upon termination of this Agreement (subject to Article 11), completion of the Purpose, or discontinuation of the use of such Materials (whichever occurs first), shall automatically terminate. Except as otherwise provided under this Agreement, all such Materials delivered by the Transferring Party to the Material Receiving Party shall remain the sole property of the Transferring Party, shall only be used by the Material Receiving Party in furtherance of the Purpose, and shall be returned to the Transferring Party or destroyed, in the Transferring Party’s sole discretion, upon the termination of this Agreement (subject to Article 11), the expiration of the Option Term with respect to any Development Candidate to which such Materials solely relate (unless the Option is exercised for the Program for which such transfer occurred), or upon the discontinuation of the use of such Materials (whichever occurs first). The

 

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Material Receiving Party shall not cause the Materials to be used by or delivered to or for the benefit of any Third Party without the prior written consent of the Transferring Party unless such Third Party is a Third Party subcontractor as set forth in Section 2.7.

2.8.3. No Warranties; Liability . THE MATERIALS SUPPLIED BY THE TRANSFERRING PARTY UNDER THIS SECTION 2.8 ARE SUPPLIED “AS IS” AND, EXCEPT AS OTHERWISE SET FORTH IN THIS AGREEMENT, THE TRANSFERRING PARTY MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE MATERIALS OR USE THEREOF DO NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS OF A THIRD PARTY. The Material Receiving Party assumes all liability for Damages that may arise from its use, storage or disposal of the Materials. Except as otherwise set forth in this Agreement, the Transferring Party shall not be liable to the Material Receiving Party for any loss, claim or demand made by the Material Receiving Party, or made against the Material Receiving Party by any Third Party, due to or arising from the use of the Materials, except to the extent such loss, claim or demand is caused by the gross negligence or willful misconduct of the Transferring Party.

2.9 Reversion of Rights.

2.9.1. Juno Programs . If Celgene does not exercise its Option with respect to any Juno Programs within the applicable Option Term for such Juno Program, upon expiration of the Option Term for such Juno Program, (a) all rights granted by Juno to Celgene with respect to such Juno Program, if any, shall revert to Juno, and (b) subject to Article 8, Celgene shall return to Juno, or destroy, at Juno’s option, all Confidential Information and/or Materials provided by Juno to Celgene in relation to such Juno Program during the applicable Option Term, unless related to another then-existing Juno Program, and Section 11.8 shall apply.

2.9.2. Celgene Programs . If Juno does not exercise its Option with respect to any Celgene Programs within the applicable Option Term for such Celgene Program, upon expiration of the Option Term for such Celgene Program, (a) all rights granted by Celgene to Juno with respect to such Celgene Program, if any, shall revert to Celgene, and (b) subject to Article 8, Juno shall return to Celgene, or destroy, at Celgene’s option, all Confidential Information and/or Materials provided by Celgene to Juno in relation to such Celgene Program during the applicable Option Term, unless related to another then-existing Celgene Program, and Section 11.9 shall apply.

2.9.3. Expiration of Options . Notwithstanding anything to the contrary in this Agreement, [***], each and every Option and BD Option granted by one Party to the other Party pursuant to this Agreement, and each and every Option and Option Term for any Program for which a Party has not delivered an Option Exercise Notice pursuant to Section 3.1.3 or BD Option Exercise Notice pursuant to Section 2.2.1(a), shall expire on the expiration of the Research Collaboration Term. On a Program-by-Program or BD Program-by-BD Program basis, if a Party does not exercise its Option with respect to a Program within the Option Period for

 

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such Program or the expiration of the BD Option pursuant to Section 2.2.1, then Sections 11.8.1 and 11.8.2, with respect to Juno Programs, or 11.9.1 and 11.9.2, with respect to Celgene Programs, shall apply to [***] of such Program.

2.9.4. Optioned Programs . For the avoidance of doubt, none of the reversion events described in this Section 2.9 shall affect either Party’s rights with respect to any other Program for which such Party has delivered a Celgene Option Exercise Notice or a Juno Option Exercise Notice pursuant to Section 3.1.3(b) or 3.1.3(c), or a BD Option Exercise Notice pursuant to Section 2.2.1(a), as applicable, including such Party’s rights with respect to the applicable Juno Program Assets or Celgene Program Assets, as applicable (including any Development Candidates and related Diagnostic Products).

2.10 Manufacture and Supply.

The Parties intend to enter into one or more agreements that will govern the terms of manufacture and supply of Cellular Therapy Products and In Vivo Products for Programs following the exercise of an Option or BD Option for each such Program (each, a “ Manufacturing Agreement ”). Notwithstanding the foregoing, the Parties understand and agree (1) that the following principles do not set forth all of the material terms and conditions of any such Manufacturing Agreement, and (2) the Parties shall not be obligated to enter into any Manufacturing Agreement unless pursuant to definitive terms and conditions that the Parties shall mutually agree upon. If the Parties decide to enter into a Manufacturing Agreement, such Manufacturing Agreement shall incorporate the following principles, as set forth below in Sections 2.10.1 and 2.10.2, and other material terms such as pricing, as the Parties shall mutually agree upon.

2.10.1. Cellular Therapy Products .

(a) Juno will establish, itself or through Third Party contractors, [***], manufacturing facilities for Cellular Therapy Development Candidates and Products that are Cellular Therapy Products in the North America Territory. Juno [***]. Juno will have the right to establish, itself or through Third Party contractors, [***] and, as between the Parties, own and operate (directly or through Third Parties), manufacturing facilities for Cellular Therapy Development Candidates and Cellular Therapy Products in the China Territory, and shall be solely responsible for performing all regulatory activities and obtaining and maintaining all Regulatory Approvals with respect thereto; and

(b) Juno shall assist Celgene or its Third Party contractor, as further set forth in this Section 2.10.1 and in the Manufacturing Agreement, in establishing manufacturing facilities for Development Candidates and Cellular Therapy Products in the ROW Territory (the “ ROW Manufacturing Facilities ”), [***]. Celgene [***]. [***], in relation to such regulatory activities.

 

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(c) In connection with Celgene’s establishment of manufacturing facilities in the ROW Territory pursuant to subsection (b), [***] shall (i) [***] arising from activities under this Agreement or any Development & Commercialization Agreement [***], and (ii) [***] in connection with manufacturing operations. The Parties agree that [***]. [***]. [***]. The specific terms and conditions governing such [***], including any [***], shall be set forth in the Manufacturing Agreement, but such terms shall include, at a minimum, terms relating to [***].

(d) During the Research Collaboration Term, following Celgene’s establishment of ROW Manufacturing Facilities, Celgene shall [***] of the ROW Manufacturing Facilities [***]. [***] such ROW Manufacturing Facilities in connection with the foregoing, [***] in connection with such activities. The terms and conditions upon which [***] shall be set forth in the Manufacturing Agreement. For a period of [***] to be mutually agreed by the Parties [***].

 

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(e) The JMC shall remain established during the Research Collaboration Term and during any period following the expiration of the Research Collaboration Term [***], and shall be responsible for the successful establishment of Manufacturing facilities in the ROW Territory and the Manufacture and supply of Cellular Therapy Development Candidates and Cellular Therapy Products in the ROW Territory pursuant to the Manufacturing Agreement. Any disputes arising from issues discussed by the JMC shall be subject to the dispute resolution mechanism set forth in Section 4.2.5.

2.10.2. In Vivo Products . Celgene shall be responsible for the Manufacture and supply (itself or through an Affiliate or a Third Party) of Development Candidates and Products that are In Vivo Products throughout the Territory, except as otherwise provided in the Manufacturing Agreement. Celgene shall supply In Vivo Products to Juno for Development and Commercialization outside the ROW Territory at a supply price to be agreed in the Manufacturing Agreement or in the applicable Development & Commercialization Agreement. For clarity, In Vivo Products as used in this Section 2.10.2 refers to both Juno In Vivo Products and Celgene In Vivo Products.

2.11 Obligations of Affiliates . The Parties hereby covenant and agree that the obligations of each Party under this Agreement to offer any Option or BD Option related to any Program under this Article 2 shall also be deemed to be an obligation of its Affiliates.

ARTICLE 3

OPTION EXERCISE;

DEVELOPMENT & COMMERCIALIZATION AGREEMENTS

3.1 Option Grant and Exercise.

3.1.1. Option Grant by Juno . Subject to the terms and conditions of this Agreement on a Juno Program-by-Juno Program basis, Juno hereby grants to Celgene the following exclusive options (each, a “ Celgene Option ”):

(a) with respect to the CD19 Program, an exclusive option, exercisable at any time during the CD19 Option Exercise Window, to enter into a License Agreement with respect to Development Candidates [***] for the CD19 Program and any related Diagnostic Products developed therefor, as set forth in and on the terms and conditions set forth in such agreement, the form of which is attached hereto as Exhibit A (and in such case CD19 shall be deemed the “Licensed Target” thereunder and the Development Candidates in the CD19 Program shall be deemed “Licensed Candidates” thereunder).

 

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(b) with respect to the CD22 Program, an exclusive option, exercisable at any time during the CD22 Option Exercise Window, to enter into a License Agreement with respect to Development Candidates [***] for the CD22 Program and any related Diagnostic Products developed therefor, as set forth in and on the terms and conditions set forth in such agreement, the form of which is attached hereto as Exhibit A (and in such case CD22 shall be deemed the “Licensed Target” thereunder and the Development Candidates in the CD22 Program shall be deemed “Licensed Candidates” thereunder).

(c) with respect to any Juno Program other than the CD19 Program and the CD22 Program (“ Other Juno Programs ”), an exclusive option, exercisable at any time during each Option Exercise Window for such Program, to enter into either (i) for any Other Juno Program that is designated by Celgene, [***], as a Celgene Co-Promote Program pursuant to Section 3.1.4, a Co-Development and Co-Commercialization Agreement with respect to the Development Candidates in such Other Juno Program and any related Diagnostic Products developed therefor, as set forth in and on the terms and conditions set forth in such agreement, the form of which is attached hereto as Exhibit B (and in such case the Target for such Other Juno Program shall be deemed the “Juno Program Co-Co Target” thereunder and the Development Candidates for such Other Juno Program shall be deemed “Juno Program Co-Co Candidates” thereunder), or (ii) except as provided in Section 3.1.5, for any Other Juno Program that is not described in subsection (i), a License Agreement with respect to the Development Candidates [***] for such Other Juno Program and any related Diagnostic Products developed therefor, as set forth in and on the terms and conditions set forth in such agreement, the form of which is attached hereto as Exhibit A (and in such case the Target for such Other Juno Program shall be deemed the “Licensed Target” thereunder and the Development Candidates for such Other Juno Program shall be deemed “Licensed Candidates” thereunder). Notwithstanding anything to the contrary, [***] within each Program under this Section 3.1.1, [***], then neither Party would thereafter be obligated to grant to the other Party any Options [***] of such Program.

3.1.2. Option Grant by Celgene . Subject to the terms and conditions of this Agreement, on a Celgene Program-by-Celgene Program basis, Celgene hereby grants to Juno an exclusive option (each, a “ Juno Option ”), exercisable at any time during the relevant Option Exercise Window in accordance with Section 3.1.3, to enter into a Celgene Lead Co-Co Agreement with respect to the Development Candidates [***] in such Celgene Program and any related Diagnostic Products developed therefor, as set forth in and on the terms and conditions set forth in such agreement, the form of which is attached hereto as Exhibit C (and in such case the Target for such Celgene Program shall be deemed the “Celgene Program Co-Co Target” thereunder and the Development Candidates for such Celgene Program shall be deemed “Celgene Program Co-Co Candidates” thereunder). Notwithstanding anything to the contrary, [***] within each Program under this Section 3.1.2, [***], then neither Party would thereafter be obligated to grant to the other Party any Options [***] of such Program.

 

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3.1.3. Option Exercise .

(a) Within [***] (or such longer period as may be mutually agreed by the Parties) after the receipt of the applicable Data Package by a Party for a given Program the JRDC shall [***]. At any time following the [***], either Party may request that [***] in relation to [***] relating thereto. The JRDC shall [***]. Any [***] shall be [***] shall be subject to [***] Section 3.1.5. Notwithstanding any of the foregoing, if a Party exercises its Option or a BD Option for a Program with respect to [***], and such Party subsequently [***] shall nonetheless be [***] subject to [***] Section 3.1.5.

(b) On a Juno Program-by-Juno Program basis, within [***] following the occurrence of each Data Package Trigger Event for each such Juno Program, unless Celgene waives such obligation in writing in advance, Juno shall provide to Celgene the applicable Data Package. During the applicable Option Exercise Window for such Juno Program during the applicable Option Term, Celgene shall have the right, but not the obligation, to exercise the Option for such Program, which shall thereby become a Designated Program, [***] by delivering written notice of such exercise (the “ Celgene Option Exercise Notice ”) to Juno within the applicable Option Exercise Window. Simultaneously with the delivery of the Celgene Option Exercise Notice, Celgene shall also [***] shall determine (i) the scope of the Parties’ respective exclusivity obligations pursuant to Article 5 with respect to such Juno Program, and (ii) shall define the scope of each Party’s Development and Commercialization rights and responsibilities under the applicable Development & Commercialization Agreement for such Juno Program. Within [***]

 

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[***] following each Celgene Option Exercise Notice delivery, or if later the Antitrust Clearance Date (if applicable), subject to Section 3.2, Celgene (or an Affiliate designated by Celgene) and Juno will enter into a License Agreement with respect to such Designated Program [***], unless Section 3.1.4(b) applies, in which case Celgene and Juno shall enter into a Juno Lead Co-Co Agreement, and in either case will update the exhibits and schedules thereto. Simultaneous with the entry into the applicable Development & Commercialization Agreement, Celgene shall pay the applicable amount due upon exercise of such Option, in accordance with Section 6.4 and as set out in Exhibit C to such Development & Commercialization Agreement. Any [***] such Juno Program, [***] at the time Celgene exercises the Option for such Designated Programs [***] for such Designated Program, and [***], including any Programs that [***] shall be subject to [***] Section 3.1.5.

(c) On a Celgene Program-by-Celgene Program basis, unless Juno waives such obligation in writing in advance, within [***] following the occurrence of each Data Package Trigger Event for each such Celgene Program, Celgene shall provide to Juno the applicable Data Package. During each applicable Option Exercise Window for such Celgene Program during the applicable Option Term, Juno shall have the right, but not the obligation, to exercise the Option for such Program, which shall thereby become a Designated Program, [***] by delivering written notice of such exercise (the “ Juno Option Exercise Notice ”) to Celgene within the applicable Option Exercise Window for such Celgene Program. Simultaneously with the delivery of the Juno Option Exercise Notice, Juno [***] such Celgene Program for which it is exercising its Option, [***] for such Designated Program. Such [***] shall determine (a) the scope of the Parties’ respective exclusivity obligations pursuant to Article 5 with respect to such Designated Program, and (b) shall define the scope of each Party’s Development and Commercialization rights and responsibilities under the applicable Development & Commercialization Agreement for such Designated Program. Within [***] following each Juno Option Exercise Notice delivery, or any relevant Antitrust Clearance Date, if later, and subject to Section 3.2, Celgene (or an Affiliate designated by Celgene) and Juno will enter into the applicable Development & Commercialization Agreement with respect to such Designated Program, and will update the exhibits and schedules thereto. Juno shall pay the applicable amount due upon exercise of such Option, in accordance with Section 6.4 and as set out in Exhibit C to such Development & Commercialization Agreement. Any [***] such Celgene Program, [***] at the time Juno exercises the Option for such Celgene Programs [***] for such Designated Program, and [***], including any Programs that [***], shall be subject to [***] Section 3.1.5.

(d) If a Party exercises its Option with respect to a particular Program offered to the Collaboration by the other Party (“ Offering Party ”), or BD Option for any Eligible BD

 

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Program pursuant to Section 2.2.1, including [***] pursuant to Section 3.1.5, such Party shall, upon such exercise, be deemed the “ Designating Party ” for such Program, and such Program shall, upon such exercise, be deemed the Designated Program. Upon the exercise of (i) an Option by Celgene for a Juno Program, or Juno for a Celgene Program, as applicable, pursuant to this Section 3.1.3, (ii) a BD Option by a BD Evaluating Party for an Eligible BD Program pursuant to Section 2.2.1, or (iii) an Option by either Party [***] pursuant to Section 3.1.5, the Parties will update Exhibit B of the applicable Development & Commercialization Agreement [***] for each such Designated Program.

(e) Notwithstanding subsections (a) through (c), if a Data Package Party delivers a [***] Data Package for a Program to the other Party, such other Party does not exercise its Option or BD Option during the [***] Option Exercise Window for such Program, and the Data Package Party subsequently elects [***] for a Development Candidate in such Program, but [***] for such Program, the Data Package Party shall, within [***] of [***] for such Program, notify the other Party in writing of such [***] (the “[***] Notice ”), and such other Party shall have an additional right, but not the obligation, to exercise the Option or BD Option for such Program in its sole discretion within [***] following its receipt of the [***] Notice, by delivering an Option Exercise Notice to the Data Package Party in accordance with Section 3.1.3(a) or Section 3.1.3(c), or BD Option Exercise Notice in accordance with Section 2.2.1(a), as applicable, provided that if such other Party elects not to exercise its Option or BD Option with respect to such Program within such [***] period, unless such Data Package Party did not [***], in which case the Data Package Party shall continue to have the applicable obligations under this Section 3.1.3 for such Program.

(f) If a Party has the right to exercise an Option or BD Option with respect to [***], such Party shall also have the right to exercise its Option or BD Option with respect to [***].

(g) Notwithstanding anything to the contrary, the Parties shall not be required to enter into a Development & Commercialization Agreement for the Program until the Antitrust Clearance Date.

3.1.4. Celgene Right to Elect to Co-Promote .

(a) Simultaneous with, or following Celgene’s exercise of the Option for a [***] Program (other than the CD19 Program and the CD22 Program), including [***] Program for which Celgene exercises an Option pursuant to Section 3.1.5, Celgene shall have the right (the “ Celgene Co-Promote Right ”), exercisable by written notice to Juno at any time prior to the later to occur of (a) the [***] such Juno Program or [***] Program, as

 

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applicable, or (b) [***] after Celgene receives notice, including if such matter is discussed at the JRDC or JSC, that [***], to designate such [***] Program, as applicable, as a “ Celgene Co-Promote Program ”;

(b) If Celgene designates such a [***] Program, as applicable, as a Celgene Co-Promote Program at the time Celgene delivers a Celgene Option Exercise Notice for such Juno Program or an [***] Option Exercise Notice for such [***] Program, as applicable, then the Parties shall enter into a Juno Lead Co-Co Agreement for such Program at the time of the exercise of the Option;

(c) If Celgene does not elect to designate such [***] Program as a Celgene Co-Promote Program at the time of its exercise of the Option for such Program other than the CD19 Program or the CD22 Program, then the Parties shall enter into a License Agreement with respect to such [***] Program, and if Celgene exercises the Celgene Co-Promote Right at a later date in accordance with Section 3.1.4(a), then at such time, the Parties will terminate such License Agreement and simultaneously enter into a Juno Lead Co-Co Agreement; and

(d) The Celgene Co-Promote Right shall apply to up to two (2) Programs (subject to subsection (e) below) that are [***] provided that [***], as set forth in Section 3.1.4(e) below, unless [***], in which case Celgene may exercise the Celgene Co-Promote Right for one (1) additional [***] Program [***] described in (i) or (ii) (other than a CD19 Program or the CD22 Program) (such number of Programs for which Celgene Co-Promote Rights apply, the “ Maximum Number of Co-Promote Rights ”). Furthermore, where Celgene exercises the Celgene Co-Promote Right for a Designated Program, (A) such Celgene Co-Promote Right shall apply to all other Designated Programs for which Celgene has already exercised its Option [***], and (B) if Celgene subsequently exercises an Option with respect to [***], then (1) such [***], (2) Celgene shall be deemed [***], and (3) such [***] shall be subject to the terms of, the existing Juno Lead Co-Co Agreement for the Designated Program, and Exhibit B of such Juno Lead Co-Co Agreement will be updated [***], and for each of (A) and (B) such [***] Program, as applicable, shall not count against the Maximum Number of Co-Promote Rights.

(e) Solely for purposes of determining the Maximum Number of Co-Promote Rights available to Celgene pursuant to Section 3.1.4(d), [***], the following shall apply:

 

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(i) where [***] Program are [***], including without limitation any [***], then such [***] shall be [***]. [***];

(ii) where a [***] Program for which Celgene exercises its Option [***] Program [***], on the one hand, and [***], on the other hand, [***], and such [***] will not be [***];

(iii) where a [***] Program for which Celgene exercises its Option includes a [***] a Program [***], on the one hand, and[***], on the other hand, , [***], and such [***] will not be [***], but will be [***];

(iv) where a [***] Program for which Celgene exercises its Option includes a [***] Program [***], on the one hand, and [***], on the other hand, [***], and such [***] will not be [***], but will be [***]; and

(v) where a [***] Program for which Celgene exercises its Option includes a [***] Program [***], on the one hand, and [***], on the other hand, [***], and such [***] will be [***] (i) [***], (ii) [***], and (iii) [***].

(f) Notwithstanding the foregoing (a) through (e), Celgene may not exercise the Celgene Co-Promote Right for any Designated Program that [***] for which Celgene or its Affiliate has [***] and for which [***].

 

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3.1.5. Option for Existing or Later Acquired or Developed Programs; Offer Back and Opt-In .

(a) For so long as [***] within any Designated Program remain in effect, if at or after the Designating Party’s delivery of an Option Exercise Notice or a BD Option Exercise Notice, as applicable, for such Designated Program, either Party [***], then solely with respect to such [***] Program(s), such Party shall be required to offer to the other Party the right to exercise an Option with respect to such [***] Program; provided that (A) if the [***], then the Party offering such [***] Program shall [***], and (B) if [***] BD Program contains any Product [***] that is either (x) a Product [***], or, (y) [***], then (1) the Party to whom such [***] Program (other than [***]) is being offered shall [***] the Development and Commercialization of [***], and (2) if with respect to such [***] the Party offering such [***] Program is [***], and where the Designated Program is the [***], then [***] would not [***]. For clarity, the other Party may exercise an Option for [***] Program that [***]. Notwithstanding the foregoing, a Party shall not be obligated to offer to the other Party pursuant to this Section 3.1.5 any [***] Program that [***].

(b) Notwithstanding Section 3.1.5(a), if a Party [***] during the Research Collaboration Term an [***] with respect to [***] Program that are [***], such Party will not be deemed to have acquired a license or other rights with respect to [***] BD Program unless and until such Party [***] (and such

 

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Program becomes a Celgene [***] Program or a Juno [***] Program, as applicable). Notwithstanding the previous sentence and subject to Section 3.1.5(a), if, [***], a Party retains the right to [***] with respect to a program of activities [***], to the extent still subject to a Development & Commercialization Agreement, that would have become [***], then if such Party [***] at any time [***], such Party shall [***] this Section 3.1.5, and such activities shall [***].

(c) If the [***] Program is (i) an [***] Program of a Party, then (A) within [***] Program, or (B) within [***] of the exercise of an Option for a Designated Program offered by the other Party that [***] Program (if at the time of the exercise of such Option, such [***]), or (ii) an [***] licensed or acquired by either Party, within [***] after the acquisition of rights in, in-license of, or exercise of an option under, such [***] BD Program, the Party offering such [***] Program shall provide to the other Party:

(1) information relating to such [***] Program that [***] Program if such [***] Program [***], and all information, including any [***] of such Product) in the Control of the Party offering such [***] Program that is [***] the research and Development of such [***] Program; or

(2) if the [***] Agent has (x) progressed beyond the [***] (determined as if such [***]), or (y) has progressed beyond the [***] (such that Section 3.1.3(e) would not apply to such [***] Program) all information in the Control of the Party offering such [***] Program that is [***] the research and Development of such [***] Program, subject to limitations on offering Products pursuant to Section 3.1.5(a) with respect to [***],

in each case to enable the other Party to determine whether it wishes to exercise an Option in accordance with the procedure set forth in Section 3.1.3 for such [***] Program.

 

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The information and materials provided by the Party offering such [***] Program to the other Party shall be deemed the “[***] Data Package ”.

(d) Following the provision by a Party of [***] Data Package to the other Party, such other Party shall have the right, but not the obligation, to exercise an Option for such [***] Program by delivering written notice of such exercise (the “[***] Option Exercise Notice ”) to the offering Party within the applicable Option Exercise Window for such [***], or for [***] Programs described in Section 3.1.5(c) above, [***] after the provision of such required information, provided that in each case, if the other Party requests additional reasonable information and clarifications during the first [***] of such [***] period, then such [***] period will be automatically extended (as necessary) for up to an additional [***] period, during which period such other Party may continue to request additional reasonable information and clarifications and the Party offering such [***] Program shall provide such information and clarifications to such other Party.

(e) If a Party delivers an [***] Option Exercise Notice to the other Party for an [***] Program pursuant to subsection (d), then the Party exercising such Option shall be required to pay either (i) where the [***] Program is an [***] Program, a Designation Payment with respect to such Option as set forth in Section 6.4, or (ii) where the [***] Program is an [***] Program, an [***] BD Opt-In Payment as set forth in Section 6.5.3.

(f) Following the exercise by a Party of an Option in accordance with subsection (d) above, such [***] Program shall be considered [***] Development & Commercialization Agreement or a [***] under the Collaboration, as applicable; provided that, solely for purposes of the exercisable Celgene Co-Promote Rights granted under Section 3.1.4, any such designation or new Designated Program [***], and the Parties shall enter into, and shall be subject to the terms of a Development & Commercialization Agreement as set forth in Schedule 3.1.5.

(g) If a Party does not exercise its Option for an [***] Program [***] such [***] Program is offered to such Party pursuant to subsection (a), then (i) if such [***] Program has [***] at the time such Party elects not to exercise the Option for such [***] Program, then the Party Developing or acquiring such [***] Program shall [***] Program within the Collaboration, and [***] to such [***] Program, and (ii) if such [***], then such [***] Program shall thereafter [***], and shall be subject to each Party’s right to exercise its Option for such [***] Program as set forth in Section 3.1.3.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(h) Notwithstanding the foregoing, if, as of the date of a Party’s delivery of an Option Exercise Notice, such Party (A) [***] or (B) [***] that with respect to a [***] ([***] subject to the Collaboration) but [***], then if [***], such [***] will not [***] within an [***] for a Program [***].

(i) Notwithstanding anything to the contrary, on [***] within each Program under this Section 3.1.5, if pursuant to Sections 5.1.1(d)(i), 5.1.2, 5.1.3 or 5.5.2, either Party’s exclusivity obligations have expired [***], then [***] of such Program.

3.1.6. Juno Covenants During Option Term . Except to the extent expressly permitted under Article 5, on a Juno Program-by-Juno Program basis, commencing on the Effective Date until expiration of the applicable Option Term, neither Juno nor its Affiliates will, other than to an Affiliate of Juno who agrees in writing to be bound by the terms and conditions of this Agreement (a) assign, transfer, convey, encumber (including any liens or charges, but excluding any licenses, which are the subject of subsection (b), below) or dispose of, or enter into any agreement with any Third Party to assign, transfer, convey, encumber (including any liens or charges, but excluding any licenses, which are the subject of subsection (b), below) or dispose of, any assets [***] (with respect to each Juno Program, the “ Juno Program Assets ”), except to the extent such assignment, transfer, conveyance, encumbrance or disposition [***] of this Agreement or any applicable Development & Commercialization Agreement with respect to such Juno Program, (b) license or grant to any Third Party, or agree to license or grant to any Third Party, any rights to any Juno Program Assets if such license or grant would [***] this Agreement or any applicable Development & Commercialization Agreement with respect to such Juno Program, or (c) [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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[***] the Juno Program Assets to any Third Party if such [***] would [***] with respect to such Juno Program. Notwithstanding Section 3.1.6(a), Juno and/or its Affiliates shall have the right to assign, transfer, convey or dispose of any assets specifically related to such Juno Program to any Affiliate of Juno; provided that (i) such Affiliate is bound by the terms and conditions of this Agreement, and (ii) such assignment, transfer, conveyance or disposal does not [***] this Agreement or any applicable Development & Commercialization Agreement with respect to such Juno Program.

3.1.7. Celgene Covenants During Option Term . Except to the extent expressly permitted under Article 5, on a Celgene Program-by-Celgene Program basis, commencing on the Effective Date until expiration of the applicable Option Term, neither Celgene nor its Affiliates will, other than to an Affiliate of Celgene who agrees in writing to be bound by the terms and conditions of this Agreement, (a) assign, transfer, convey, encumber (including any liens or charges, but excluding any licenses, which are the subject of subsection (b), below) or dispose of, or enter into any agreement with any Third Party to assign, transfer, convey, encumber (including any liens or charges, but excluding any licenses, which are the subject of subsection (b), below) or dispose of, any assets [***] (with respect to each Celgene Program, the “ Celgene Program Assets ”), except to the extent such assignment, transfer, conveyance, encumbrance or disposition would [***] this Agreement or any applicable Co-Development & Co-Commercialization Agreement with respect to such Celgene Program, (b) license or grant to any Third Party, or agree to license or grant to any Third Party, any rights to any Celgene Program Assets if such license or grant [***] this Agreement or any applicable Co-Development & Co-Commercialization Agreement with respect to such Celgene Program, or (c) [***] the Celgene Program Assets to any Third Party if [***] would [***] this Agreement with respect to such Celgene Program. Notwithstanding Section 3.1.7(a), Celgene and/or its Affiliates shall have the right to assign, transfer, convey or dispose of any assets specifically related to such Celgene Program to any Affiliate of Celgene; provided that (i) such Affiliate is bound by the terms and conditions of this Agreement, and (ii) such assignment, transfer, conveyance or disposal does not [***] this Agreement or any applicable Development & Commercialization Agreement with respect to such Celgene Program.

3.1.8. Expiration of Option Term . The Option Terms for all Programs for which the Option has not previously been exercised shall expire on the expiration of the Research Collaboration Term (the “ Research Term Expiration ”), provided that with respect to any Juno Program or Celgene Program that is an Active Program for which the Option has not been exercised as of the Research Term Expiration, and [***] as of such date, the Option Term may be extended for a limited period as follows:

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(a) if the Offering Party has [***] for such Program but [***] for such Active Program [***] Data Package prior to the Research Term Expiration, then upon the Research Term Expiration, the Option Term for such Active Program shall remain open, and within [***] following the Research Term Expiration, the Offering Party shall provide to the other Party (the “ Option Extending Party ”) information relating to such Active Program [***] such Active Program, and all information, including [***] Data Package [***] in the Offering Party’s Control that is [***] such Active Program, in order to enable the other Party to decide whether it wishes to exercise an Option for such Active Program by delivery of an Option Exercise Notice in accordance with the procedure set forth in Section 3.1.3. The Option Extending Party shall have [***] in which to deliver an Option Exercise Notice in accordance with Section 3.1.3(a) (if the Active Program is a Juno Program) or Section 3.1.3(c) (if the Active Program is a Celgene Program), provided, that if the Option Extending Party requests additional reasonable information and clarifications during the [***] period, during which period such Party may continue to request additional reasonable information and clarifications and the Offering Party shall provide such information and clarifications to such Option Extending Party. If the Option is exercised, the Option Exercise Notice shall include a [***] such Active Program for which the Option Extending Party is exercising its Option;

(b) if, as of the Research Term Expiration, the [***] has expired without the Option being exercised, [***] has not yet occurred, then the Option Term for such Active Program shall extend until the occurrence of the next to occur Data Package Trigger Event for such Active Program, provided that the Option Term shall not extend beyond the [***] the Research Term Expiration. In such case, the Offering Party shall present the applicable Data Package to the Option Extending Party, and the Option Extending Party shall have a final right to exercise its Option for such Active Program (and to [***] such Active Program [***] for such Program simultaneously with such Option exercise), in accordance with Section 3.1.3(b) (if the Active Program is a Juno Program), or Section 3.1.3(c) (if the Active Program is a Celgene Program) during the time periods set forth therein; and

(c) if an Option Extending Party does not exercise such Option during the time periods provided in (a) and (b) above, then the Option Term shall expire [***], or the time periods set forth therein, and such Program shall no longer be subject to the Option Extending Party’s rights under this Agreement, including Article 5.

3.1.9. Financial Participation for Programs that are not Eligible BD Programs . If a Celgene Program or Juno Program, [***] that one Party is obligated to offer to the other Party for exercise of an Option pursuant to Section 3.1.3 or 3.1.5,

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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[***] include such Program in the Collaboration and grant to the other Party the right to exercise an Option and enter into a Development & Commercialization Agreement with respect thereto, [***]. In such case, the [***] (i) with respect to a Celgene Program [***], (ii) except as described in (i), (iii) and (iv), with respect to a Juno Program [***], in each case with respect to [***], or (iii) with respect to a Juno Program [***], (iv) with respect to [***], provided that for each of (ii) through (iv), if [***] such Juno Programs, then [***] (and the [***]). For clarity, any Juno Program that [***].

3.2 Government Approvals.

3.2.1. Efforts . Each of Juno and Celgene will use its commercially reasonable good faith efforts to eliminate any concern on the part of any Governmental Authority regarding the legality of any proposed Development & Commercialization Agreement and the Share Purchase Agreement (the “ Implementing Agreements ”) including, if required by Governmental Authorities, promptly taking all steps to remove any and all impediments to consummation of the

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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transactions contemplated by the Implementing Agreements, including obtaining government antitrust clearance, cooperating in good faith with any Governmental Authority investigation, promptly producing any documents and information and providing witness testimony if requested by a Governmental Authority. Notwithstanding anything to the contrary in this Agreement and the Implementing Agreements, this Section 3.2 and the term “commercially reasonable good faith efforts” do not require that either Party (i) [***], (ii) [***], or (iii) [***].

3.2.2. HSR/Antitrust Filings . Each of Juno and Celgene will, within [***] after the execution of the relevant Implementing Agreement (or such later time as may be agreed to in writing by the Parties) file with the U.S. Federal Trade Commission (“ FTC ”) and the Antitrust Division of the U.S. Department of Justice (“ DOJ ”) any HSR/Antitrust Filing required of it under the HSR Act and, as soon as practicable, file with the appropriate Governmental Authority any other HSR/Antitrust Filing required of it under any other Antitrust Law as determined in the reasonable opinion of either Party with respect to the transactions contemplated by the relevant Implementing Agreement. The Parties shall cooperate with one another to the extent necessary in the preparation of any such HSR/Antitrust Filing. Each Party shall be responsible for its own costs, expenses, and filing fees associated with any HSR/Antitrust Filing; provided, however, the Parties shall [***]. In the event that the Parties make an HSR/Antitrust Filing under this Section 3.2, the relevant Implementing Agreement shall terminate (i) at the election of either Party, immediately upon notice to the other Party, in the event that the FTC, DOJ or other Governmental Authority obtains a preliminary injunction or final order under Antitrust Law enjoining the transactions contemplated by such Implementing Agreement, or (ii) at the election of either Party, immediately upon notice to the other Party, in the event that the Antitrust Clearance Date shall not have occurred on or prior to [***] after the effective date of the last HSR/Antitrust Filing submitted to a Governmental Authority in relation to the relevant Implementing Agreement. Notwithstanding anything to the contrary contained herein, except for the terms and conditions of this Section 3.2, none of the terms and conditions contained in the relevant Implementing Agreement shall be effective until the “ Implementation Date , ” which is agreed and understood to mean the later of (A) the execution date of the relevant Implementing Agreement, (B) if a determination is made pursuant to this Section 3.2 that an HSR/Antitrust Filing is not required to be made under any Antitrust Law for the relevant Implementing Agreement, the date of such determination, or (C) if a determination is made pursuant to this Section 3.2 that an HSR/Antitrust Filing is required to be made under any Antitrust Law for the relevant Implementing Agreement, the Antitrust Clearance Date. As used herein: (x) “ Antitrust Clearance Date ” means the earliest date on which the Parties have actual knowledge that all applicable waiting periods under the HSR Act and any comparable waiting periods as required

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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under any other Antitrust Law, in each case with respect to the transactions contemplated by the relevant Implementing Agreement have expired or have been terminated; and (y) “ HSR/Antitrust Filing ” means (a) a filing by Juno and Celgene with the FTC and the DOJ of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act), together with all required documentary attachments thereto or (b) any comparable filing by Juno or Celgene required under any other Antitrust Law, in each case ((a) and (b)) with respect to the transactions contemplated by the Implementing Agreements.

3.2.3. Information Exchange . Each of Juno and Celgene will, in connection with any HSR/Antitrust Filing, (i) reasonably cooperate with each other in connection with any communication, filing or submission and in connection with any investigation or other inquiry, including any proceeding initiated by a private party; (ii) keep the other Party and/or its counsel informed of any communication received by such Party from, or given by such Party to, the FTC, the DOJ or any other U.S. or other Governmental Authority and of any communication received or given in connection with any proceeding by a private party, in each case regarding the transactions contemplated by any Implementing Agreement; (iii) consult with each other in advance of any meeting or conference with the FTC, the DOJ or any other Governmental Authority or, in connection with any proceeding by a private party, with any other Person, and to the extent permitted by the FTC, the DOJ or such other Governmental Authority or other Person, give the Parties and/or their counsel the opportunity to attend and participate in such meetings and conferences; and (iv) to the extent practicable, permit the other Party and/or its counsel to review in advance any submission, filing or communication (and documents submitted therewith) intended to be given by it to the FTC, the DOJ or any other Governmental Authority; provided, that materials may be redacted to remove references concerning the [***]. Juno and Celgene, as each deems advisable and necessary, may reasonably designate any competitively sensitive material to be provided to the other under this Section 3.2.3 as “Antitrust Counsel Only Material.” Such materials and the information contained therein shall be given only to the outside antitrust counsel of the recipient and will not be disclosed by such outside counsel to employees, officers or directors of the recipient unless express permission is obtained in advance from the source of the materials (Juno or Celgene, as the case may be) or its legal counsel.

3.2.4. Assistance Unrelated to Antitrust Law . Subject to this Section 3.2, Juno and Celgene shall cooperate and use respectively all reasonable efforts to make all other registrations, filings and applications, to give all notices and to obtain as soon as practicable all governmental or other consents, transfers, approvals, orders, qualifications, authorizations, permits and waivers, if any, and to do all other thing necessary or desirable for the consummation of the transactions as contemplated hereby.

3.2.5. No Further Obligations . If an Implementing Agreement is terminated pursuant to this Section 3.2, then, notwithstanding any provision in this Agreement to the contrary, neither Party shall have any further obligation to the other Party with respect to the subject matter of the relevant Implementing Agreement; provided, that Celgene shall be permitted to [***], if required to comply with any Antitrust Law.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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3.3 Obligations of Affiliates. The Parties hereby covenant and agree that the obligations of each Party under this Agreement to offer any Option or BD Option related to any Program under this Article 3 shall also be deemed to be an obligation of its Affiliates.

ARTICLE 4

GOVERNANCE

4.1 Generally.

4.1.1. Committees .

(a) Establishment . Pursuant to this Article 4, the Parties will establish a joint steering committee (“ JSC ”), a joint research and development committee (“ JRDC ”), a joint manufacturing committee (“ JMC ”), a joint patent committee (the “ Patent Committee ”), a joint commercialization committee (“ JCC ”), and a joint business development committee (“ JBDC ”) (collectively, along with any New Committee, the “ Collaboration Committees ”) within the timeframes set forth in Sections 4.2.1, 4.3.1, 4.4.1, 4.5.1, 4.6.1 and 4.7.1. The Parties may also determine to establish additional new committees to oversee particular phases of the Collaboration (each, a “ New Committee ”). Unless otherwise agreed upon by the Parties (including with respect to when such New Committee shall disband), each New Committee shall follow the provisions set forth for the JSC, and shall be subject to the authority of the JSC. Each Collaboration Committee shall have decision-making authority with respect to the matters within its purview to the extent expressly and as more specifically provided herein.

(b) Subcommittees . From time to time, any of the Collaboration Committees may establish subcommittees to oversee particular projects or activities, as it deems necessary or advisable (each, a “ Subcommittee ”). Each Subcommittee shall consist of such number of members as the applicable Collaboration Committee determines is appropriate from time to time. Such members shall be individuals with expertise and responsibilities in the relevant areas within the purview of such Collaboration Committee, such as [***], as applicable to the stage of the project or activity. Such Subcommittees shall operate under the same principles as are set forth in this Article 4 for the committee forming such Subcommittee.

4.1.2. Execution of Development & Commercialization Agreement . On a Program-by-Program basis, upon execution of the applicable Development & Commercialization Agreement for such Program, respectively, such Program and matters related thereto shall continue to be within the purview of the Collaboration Committees, in accordance with, and solely pursuant to, the terms of Section 4.2.4 and such Development & Commercialization Agreement, as applicable.

4.1.3. Alliance Managers . Promptly after the Effective Date, each Party shall appoint an individual to act as alliance manager for such Party, which may be one of the representatives of such Party on the JSC (each, an “ Alliance Manager ”). The Alliance Managers shall be the primary point of contact for the Parties regarding the activities

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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contemplated by this Agreement and shall facilitate all such activities hereunder. The Alliance Managers shall attend all meetings of the JSC and shall be responsible for assisting the JSC in performing its oversight responsibilities. The name and contact information for each Party’s Alliance Manager, as well as any replacement(s) chosen by such Party, in its sole discretion, from time to time, shall be promptly provided to the other Party in accordance with Section 12.2.

4.1.4. Patent Liaisons . Promptly after the Effective Date, each Party shall appoint an individual to act as a patent liaison for such Party, which may be one of the representatives of such Party on the Patent Committee (each, a “ Patent Liaison ”). The Patent Liaisons shall be the primary point of contact for the Parties regarding intellectual property-related activities and matters contemplated by this Agreement and shall facilitate all such activities and matters hereunder. The Patent Liaisons shall attend all meetings of the Patent Committee and shall be responsible for assisting the Patent Committee in performing its oversight responsibilities. The name and contact information for each Party’s Patent Liaison, as well as any replacement(s) chosen by such Party, in its sole discretion, from time to time, shall be promptly provided to the other Party in accordance with Section 12.2.

4.2 Joint Steering Committee.

4.2.1. Establishment; Meetings . Within [***] after the Effective Date, the Parties shall establish the JSC as more fully described in this Section 4.2. The JSC shall have review, oversight and decision-making responsibilities for all activities performed under the Collaboration, to the extent expressly and as more specifically provided herein. Each Party agrees to keep the JSC informed of its progress and activities under the Collaboration. The first scheduled meeting of the JSC shall be held no later than [***] after establishment of the JSC unless otherwise agreed by the Parties. After the first scheduled meeting of the JSC and continuing thereafter until the JSC is disbanded, the JSC shall meet in person or telephonically at [***], and more or less frequently as the Parties mutually deem appropriate, on such dates and at such places and times as provided herein or as the Parties shall agree. The chairperson shall coordinate with the other Party to establish an agenda reasonably in advance of each meeting of the JSC. The JSC shall disband upon the expiration or termination of this Agreement in its entirety. Meetings that are held in person shall alternate between the offices of the Parties, or such other location as the Parties may agree. The members of the JSC also may convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate. Each Party will bear all expenses it incurs in regard to participating in all meetings of the JSC, including all travel and living expenses.

4.2.2. Membership . The JSC shall be comprised of three (3) representatives (or such other number of representatives as the Parties may mutually agree) from each of Celgene and Juno. Each representative of a Party shall have sufficient seniority and expertise in biotechnology and pharmaceutical drug discovery, development and/or commercialization to participate on the JSC. [***] shall have the right to designate the initial chairperson of the JSC, who shall serve for an initial term of [***], and thereafter the selection of the chairperson shall alternate between the Parties every year. Each Party may replace any or all of its representatives on the JSC at any time upon written notice to the other Party in accordance with Section 12.2. The chairperson of the JSC shall have no final decision making authority with regard to any matters within the jurisdiction of the JSC. Each Party may, subject to the other Party’s prior

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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approval, invite non-member representatives of such Party and any Third Party to attend meetings of the JSC as non-voting participants; provided, that any such representative or Third Party is bound by obligations of confidentiality, non-disclosure and non-use consistent with those set forth herein prior to attending such meeting and provided, further, that such Third Party shall not have any voting or decision-making authority on the JSC.

4.2.3. General Responsibilities . Except as otherwise set forth in this Section 4.2, the JSC shall perform the following general functions, subject to the final decision-making authority of the Person set forth in Section 4.2.5: (a) review and monitor progress of the Collaboration and the Parties’ activities under each executed Development & Commercialization Agreement (as further set forth in each such Development & Commercialization Agreement), as applicable, including serving as a forum for exchanging information and facilitating discussions regarding the conduct of the Collaboration; (b) on a Program-by-Program basis, [***] any amendments to the applicable Development Plan proposed by the JRDC; (c) review and comment on any BD Program that is identified and presented to the JBDC, as applicable; (d) manage the strategic direction of the Collaboration; (e) oversee implementation of the Collaboration in accordance with this Agreement; (f) discuss and attempt to resolve any disputes in any Collaboration Committees and any Subcommittees; (g) approve proposals for Development of Diagnostic Products with respect to a Program prior to exercise of an Option for such Program; (h) discuss material issues and provide input to each Party regarding the enforcement and defense of applicable Collaboration IP and Joint Collaboration IP; (i) [***] proposed by the JMC; and (j) such other responsibilities as may be mutually agreed by the Parties from time to time. For purposes of clarity, the JSC shall not have any authority beyond the specific matters set forth in Sections 4.2.3 and 4.2.4, and in particular shall not have any power to amend, modify or waive the terms of this Agreement or any Development & Commercialization Agreement, or to alter, increase, expand or waive compliance by a Party with a Party’s obligations under this Agreement or any Development & Commercialization Agreement. In any case where a matter within the JSC’s authority arises, the JSC shall convene a meeting and consider such matter as soon as reasonably practicable, but in no event later than [***] after the matter is first brought to the JSC’s attention (or, if earlier, at the next regularly scheduled JSC meeting).

4.2.4. Responsibilities under Specific Agreements . Following the execution of a Development & Commercialization Agreement for a given Program, the JSC shall perform, in addition to the general responsibilities set forth in Section 4.2.3, the following functions to further Development and Commercialization of Development Candidates for a specified Program:

(a) [***] Development and Commercialization for Co-Co Products submitted to the JSC;

(b) discuss strategies for [***], in the North America Territory and the ROW Territory and review and comment on the plans of the Party responsible for leading Commercialization activities in the applicable territory (the “ Commercialization Lead Party ”) [***];

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(c) review and approve proposals from the JCC relating to Commercialization activities with global implications, including marketing materials, labeling and branding;

(d) review and approve plans and strategy for Manufacturing of Licensed Products and Co-Co Products, including plans relating to the establishment of Manufacturing and supply capabilities for Licensed Products and Co-Co Products for the North America Territory and the ROW Territory;

(e) review and comment on updates and reports on Development and Commercialization of the applicable Co-Co Products and Licensed Products; and

(f) review and comment on the Commercialization Lead Party’s strategy for the Development and Commercialization of Co-Co Products in the applicable territories.

4.2.5. Decisions . Except as otherwise set forth in this Agreement, all decisions of the JSC shall be made by consensus, with each Party having one (1) vote. If the JSC cannot agree on a matter for which the JSC has decision-making authority within [***] after it has met and attempted to reach such decision, then, either Party may, by written notice to the other, have such issue referred to the Executive Officers for resolution. The Parties’ respective Executive Officers shall meet within [***] after such matter is referred to them, and shall negotiate in good faith to resolve the matter. If the Executive Officers are unable to resolve the matter within [***], or such other longer time frame the Executive Officers may otherwise agree upon, after the matter is referred to them in accordance with this Section 4.2.5, then if the matter in dispute relates to (a) [***], (b) [***], then the [***] to which such dispute relates, shall have the final decision making authority, (c) activities or matters arising [***], and that [***], then the [***] shall have final decision making authority, or (d) activities or matters [***], including without limitation [***], the [***] shall have the final decision making authority, (e) activities or matters arising [***] shall be submitted for resolution by expert arbitration pursuant to Section 12.8.2(a), and (f) the [***] will be made by mutual agreement of the Parties, with any unresolved matters under this Section 4.2.5(f) being submitted for resolution pursuant to Section 12.8.2(a). Notwithstanding the foregoing, the Party having final decision-making authority shall not have the right to exercise its final decision-making authority to unilaterally: (i) determine that it has fulfilled any obligations under this Agreement or any Development & Commercialization Agreement or that the other Party has breached any obligation under this Agreement or any Development & Commercialization Agreement; (ii) make a decision that is expressly stated to require the mutual agreement or mutual consent of the Parties; (iii) require the conduct of, or restrict the other Party from conducting, Development activities specifically related only to such Party’s territory under a Co-Development and Co-Commercialization Agreement; (iv) otherwise expand its rights or reduce its obligations under this Agreement or any Development &

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Commercialization Agreement, or (v) decide a matter in a manner that could adversely affect the other Party’s interests in such Product, or require the other Party to incur significant expenses outside of the then-applicable Development Plan or Commercialization Plan in any material respect.

4.2.6. Minutes . The Party who designates the chairperson of the JSC shall be responsible for preparing and circulating minutes of each meeting of the JSC, setting forth, inter alia, an overview of the discussions at the meeting and a list of any actions, decisions or determinations approved by the JSC. Such minutes shall be effective only after such minutes have been approved by both Parties in writing. Definitive minutes of all JSC meetings shall be finalized no later than [***] after the meeting to which the minutes pertain.

4.3 Joint Research and Development Committee.

4.3.1. Establishment; Meetings . Within [***] after the Effective Date, the Parties shall establish the JRDC as more fully described in this Section 4.3. The JRDC shall have review, oversight and decision-making responsibilities for all activities performed under the Development Plans for each Designated Program, to the extent expressly and as more specifically provided herein. Each Party agrees to keep the JRDC informed of its progress and activities with respect to research activities performed under each Designated Program. The first scheduled meeting of the JRDC shall be held no later than [***] after the Effective Date unless otherwise agreed by the Parties. After the first scheduled meeting of the JRDC and continuing thereafter until the JRDC is disbanded, the JRDC shall meet in person or telephonically at least once each Calendar Quarter, and more or less frequently as the Parties mutually deem appropriate, on such dates and at such places and times as provided herein or as the Parties shall agree. The JRDC shall disband upon the expiration or termination of this Agreement in its entirety. Meetings that are held in person shall alternate between the offices of the Parties, or such other location as the Parties may agree. The members of the JRDC also may convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate. Each Party will bear all expenses it incurs in regard to participating in all meetings of the JRDC, including all travel and living expenses.

4.3.2. Membership . The JRDC shall be comprised of three (3) representatives (or such other number of representatives as the Parties may mutually agree) from each of Celgene and Juno. Each representative of a Party shall have sufficient seniority and expertise in biotechnology and pharmaceutical drug research and Development to participate on the JRDC. [***] shall have the right to designate the initial chairperson of the JRDC, who shall serve for an initial term of one (1) year, and thereafter the selection of the chairperson shall alternate between the Parties every year. Each Party may replace any or all of its representatives on the JRDC at any time upon written notice to the other Party in accordance with Section 12.2. Each Party may, subject to the other Party’s prior approval, invite non-member representatives of such Party and any Third Party to attend meetings of the JRDC as non-voting participants; provided,

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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that any such representative or Third Party is bound by obligations of confidentiality, non-disclosure and non-use consistent with those set forth herein prior to attending such meeting and provided, further, that such Third Party shall not have any voting or decision-making authority on the JRDC.

4.3.3. General Responsibilities – Research and Development Activities . Except as otherwise set forth in this Section 4.3, the JRDC shall perform the following general functions with respect to research and Development activities carried out under each Program following the exercise of the Option for each such Program, subject to the decision-making process set forth in Section 4.3.4:

(a) prepare and submit for approval by the JSC the Development Plan prepared by the Development Lead Party for each Designated Program, including the associated budget and allocation of responsibilities between the Parties for research and Development activities in association with such Designated Program;

(b) review and oversee implementation of the Development Plans, including monitoring progress of the Parties’ activities under each Development Plan;

(c) serving as a forum for exchanging information and facilitating discussions regarding the conduct of research and Development activities under a Designated Program;

(d) on a Program-by-Program basis, prepare and submit to the JSC for approval amendments to the applicable Development Plan proposed by either Party;

(e) discuss and attempt to resolve any disputes between the Parties relating to the Development Plans or implementation thereof, including determining whether to refer disputes for resolution by the JSC;

(f) approve [***]; and

(g) carry out such other responsibilities relating to research and Development activities as may be mutually agreed by the Parties from time to time.

4.3.4. Decisions of the JRDC . Except as otherwise set forth in this Agreement, all decisions of the JRDC shall be made by consensus, with each Party having one (1) vote. If the JRDC cannot agree on a matter for which the JRDC has decision-making authority within [***] after it has met and attempted to reach such decision, then such issue shall be referred to the JSC for resolution in accordance with Section 4.2.5. For purposes of clarity, the JRDC shall not have any authority beyond the specific matters set forth in Sections 4.3.3 and 4.3.4, and in particular shall not have any power to amend, modify or waive the terms of this Agreement or any Development & Commercialization Agreement, or to alter, increase, expand or waive compliance by a Party with a Party’s obligations under this Agreement or any Development & Commercialization Agreement. In any case where a matter within the JRDC’s authority arises, the JRDC shall convene a meeting and consider such matter as soon as reasonably practicable, but in no event later than [***] after the matter is first brought to the JRDC’s attention (or, if earlier, at the next regularly scheduled JRDC meeting).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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4.3.5. Minutes . The Party who designates the chairperson of the JRDC shall be responsible for preparing and circulating minutes of each meeting of the JRDC, setting forth, inter alia, an overview of the discussions at the meeting and a list of any actions, decisions or determinations approved by the JRDC. Such minutes shall be effective only after such minutes have been approved by both Parties in writing. Definitive minutes of all JRDC meetings shall be finalized no later than [***] after the meeting to which the minutes pertain.

4.4 Joint Manufacturing Committee.

4.4.1. Establishment; Meetings . Within [***] following the Effective Date, the Parties shall establish the JMC as more fully described in this Section 4.4. The JMC shall have review, oversight and decision-making responsibilities for all activities performed in relation to the establishment of Manufacturing and supply capabilities for Cellular Therapy Products and In Vivo Products in each Party’s territory pursuant to this Agreement and the applicable Development & Commercialization Agreement, to the extent expressly and as more specifically provided herein. Each Party agrees to keep the JMC informed of its progress and activities with respect to Development activities performed under each Program. The first scheduled meeting of the JMC shall be held no later than [***] after the Effective Date, unless otherwise agreed by the Parties. After the first scheduled meeting of the JMC and continuing thereafter until the JMC is disbanded, the JMC shall meet in person or telephonically at least once each Calendar Quarter, and more or less frequently as the Parties mutually deem appropriate, on such dates and at such places and times as provided herein or as the Parties shall agree. The JMC shall disband upon the expiration or termination of this Agreement in its entirety. Meetings that are held in person shall alternate between the offices of the Parties, or such other location as the Parties may agree. The members of the JMC also may convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate. Each Party will bear all expenses it incurs in regard to participating in all meetings of the JMC, including all travel and living expenses.

4.4.2. Membership . The JMC shall be comprised of two (2) representatives (or such other number of representatives as the Parties may mutually agree) from each of Celgene and Juno. Each representative of a Party shall have sufficient seniority and expertise in biotechnology and pharmaceutical drug research and Development to participate on the JMC. [***] shall have the right to designate the initial chairperson of the JMC, who shall serve for an initial term of one (1) year, and thereafter the selection of the chairperson shall alternate between the Parties every year. Each Party may replace any or all of its representatives on the JMC at any time upon written notice to the other Party in accordance with Section 12.2. Each Party may, subject to the other Party’s prior approval, invite non-member representatives of such Party and any Third Party to attend meetings of the JMC as non-voting participants; provided, that any such representative or Third Party is bound by obligations of confidentiality, non-disclosure and non-use consistent with those set forth herein prior to attending such meeting and provided, further, that such Third Party shall not have any voting or decision-making authority on the JMC.

4.4.3. General Responsibilities – Manufacturing Activities . Except as otherwise set forth in this Section 4.4, the JMC shall perform the following general functions, subject to the

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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decision-making process set forth in Section 4.4.4: (a) prepare plans for the establishment of capabilities for Manufacture and supply of (i) Cellular Therapy Products and (ii) In Vivo Products for clinical and commercial purposes, including the budget and timelines therefor (the “ Manufacturing Plans ”), (b) oversee the implementation of the Manufacturing Plans by the Parties, including the conduct of regulatory activities direct to obtaining Regulatory Approvals for any Manufacturing facilities in each Party’s territory, (c) serve as a forum for exchanging information and facilitating discussions regarding the initial establishment of Manufacturing facilities and capabilities, and the ongoing conduct of Manufacturing activities under a Designated Program; (d) discuss and attempt to resolve any disputes between the Parties relating to the Manufacturing Plans or implementation thereof, including determining whether to refer disputes for resolution by the JSC, and (e) discuss and agree upon the allocation between the Parties of (i) costs incurred or to be incurred to establish Manufacturing capabilities for Cellular Therapy Products in the ROW Territory, including capital expenditures incurred in relation thereto, and (ii) capital expenditures incurred or to be incurred to establish Manufacturing capabilities for In Vivo Products worldwide, in each case consistent with Section 2.10. For purposes of clarity, the JMC shall not have any authority beyond the specific matters set forth in this Section 4.4.3, and in particular shall not have any power to amend, modify or waive the terms of this Agreement or any Development & Commercialization Agreement, or to alter, increase, expand or waive compliance by a Party with a Party’s obligations under this Agreement or any Development & Commercialization Agreement. In any case where a matter within the JMC’s authority arises, the JMC shall convene a meeting and consider such matter as soon as reasonably practicable, but in no event later than [***] after the matter is first brought to the JMC’s attention (or, if earlier, at the next regularly scheduled JMC meeting).

4.4.4. Decisions of the JMC . Except as otherwise set forth in this Agreement, all decisions of the JMC shall be made by consensus, with each Party having one (1) vote. If the JMC cannot agree on a matter for which the JMC has decision-making authority within [***] after it has met and attempted to reach such decision, then such issue shall be referred to the JSC for resolution in accordance with Section 4.2.5.

4.4.5. Minutes . The Party who designates the chairperson of the JMC shall be responsible for preparing and circulating minutes of each meeting of the JMC, setting forth, inter alia, an overview of the discussions at the meeting and a list of any actions, decisions or determinations approved by the JMC. Such minutes shall be effective only after such minutes have been approved by both Parties in writing. Definitive minutes of all JMC meetings shall be finalized no later than [***] after the meeting to which the minutes pertain.

4.5 Joint Business Development Committee.

4.5.1. Establishment; Meetings . Within [***] following the Effective Date, the Parties shall establish the JBDC as more fully described in this Section 4.5. The JBDC shall provide a forum for the Parties to discuss BD Programs in-licensed or acquired by a Party and BD Technology identified by either Party, or acquired or in-licensed by a Party as set forth in Section 2.2.2. The first scheduled meeting of the JBDC shall be held no later than [***] after the Effective Date unless otherwise agreed by the Parties. After the first scheduled meeting of the

 

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JBDC until the JBDC is disbanded, the JBDC shall meet in person or telephonically at least once each Calendar Quarter, and more or less frequently as the Parties mutually deem appropriate, on such dates and at such places and times as provided herein or as the Parties shall agree. The JBDC shall disband upon the expiration or termination of this Agreement in its entirety. Meetings that are held in person shall alternate between the offices of the Parties, or such other location as the Parties may agree. The members of the JBDC also may convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate. Each Party will bear all expenses it incurs in regard to participating in all meetings of the JBDC, including all travel and living expenses.

4.5.2. Membership . The JBDC shall be comprised of one (1) representative (or such other number of representatives as the Parties may mutually agree) from each of Celgene and Juno. Each representative of a Party shall have sufficient seniority and expertise in business development activities in the fields of biotechnology and pharmaceutical drug Development and Commercialization. [***] shall have the right to designate the initial chairperson of the JBDC, who shall serve for an initial term of one (1) year, and thereafter the selection of the chairperson shall alternate between the Parties every year. Each Party may replace any or all of its representatives on the JBDC at any time upon written notice to the other Party in accordance with Section 12.2. Each Party may, subject to the other Party’s prior approval, invite non-member representatives of such Party and any Third Party to attend meetings of the JBDC as non-voting participants; provided, that any such representative or Third Party is bound by obligations of confidentiality, non-disclosure and non-use consistent with those set forth herein prior to attending such meeting and provided, further, that such Third Party shall not have any voting or decision-making authority on the JBDC.

4.5.3. General Responsibilities – Business Development Activities . Except as otherwise set forth in this Section 4.5, the JBDC shall perform the following general functions, subject to the decision-making process set forth in Section 4.5.4: (a) provide a forum for discussion and consideration of any BD Program in-licensed or acquired by either Party, (b) evaluation of any BD Technology identified, or in-licensed or acquired, by a Party as set forth in Section 2.2.2, (c) determine [***], and (d) such other responsibilities as may be mutually agreed by the Parties from time to time. For purposes of clarity, the JBDC shall not have any authority beyond the specific matters set forth in this Section 4.5.3, and in particular shall not have any power to amend, modify or waive the terms of this Agreement or any Development & Commercialization Agreement, or to alter, increase, expand or waive compliance by a Party with a Party’s obligations under this Agreement or any Development & Commercialization Agreement. In any case where a matter within the JBDC’s authority arises, the JBDC shall convene a meeting and consider such matter as soon as reasonably practicable, but in no event later than [***] after the matter is first brought to the JBDC’s attention (or, if earlier, at the next regularly scheduled JBDC meeting).

4.5.4. Decisions of the JBDC . Except as otherwise set forth in this Agreement, all decisions of the JBDC shall be made by consensus, with each Party having one (1) vote. If the JBDC cannot agree on a matter for which the JBDC has decision-making authority within [***] after it has met and attempted to reach such decision, then such issue shall be referred to the JSC for resolution in accordance with Section 4.2.5.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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4.5.5. Minutes . The Party who designates the chairperson of the JBDC shall be responsible for preparing and circulating minutes of each meeting of the JBDC, setting forth, inter alia, an overview of the discussions at the meeting and a list of any actions, decisions or determinations approved by the JBDC. Such minutes shall be effective only after such minutes have been approved by both Parties in writing. Definitive minutes of all JBDC meetings shall be finalized no later than [***] after the meeting to which the minutes pertain.

4.6 Joint Commercialization Committee . No later than the earlier of (a) the date upon which the Parties commence the first Phase 3 Clinical Trial, and (b) the date upon which the Parties commence the first Pivotal Clinical Trial, in either case for a Product in a Program, the Parties shall establish the JCC, which will have the responsibilities and decision-making rights set forth in this Section 4.6.

4.6.1. Meetings . The first scheduled meeting of the JCC shall be held no later than [***] after establishment of the JCC unless otherwise agreed by the Parties. After the first scheduled meeting of the JCC until the JCC is disbanded, the JCC shall meet in person or telephonically at least once each Calendar Quarter, and more or less frequently as the Parties mutually deem appropriate, on such dates and at such places and times as provided herein or as the Parties shall agree. The JCC shall disband upon the expiration or termination of all Co-Co Agreements. Meetings that are held in person shall alternate between the offices of the Parties, or such other location as the Parties may agree. The members of the JCC also may convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate. Each Party will bear all expenses it incurs in regard to participating in all meetings of the JCC, including all travel and living expenses.

4.6.2. Membership . The JCC shall be comprised of three (3) representatives (or such other number of representatives as the Parties may mutually agree) from each of Celgene and Juno. Each representative of a Party shall have sufficient seniority and expertise in the commercialization of pharmaceuticals to participate on the JCC. [***] shall have the right to designate the initial chairperson of the JCC, who shall serve for an initial term of one (1) year, and thereafter the selection of the chairperson shall alternate between the Parties every year. Each Party may replace any or all of its representatives on the JCC at any time upon written notice to the other Party in accordance with Section 12.2 of this Agreement. Each Party may, subject to the other Party’s prior approval, invite non-member representatives of such Party and any Third Party to attend meetings of the JCC as non-voting participants; provided, that any such representative or Third Party is bound by obligations of confidentiality, non-disclosure and non-use consistent with those set forth herein prior to attending such meeting and provided, further, that such Third Party shall not have any voting or decision-making authority on the JCC.

4.6.3. General Responsibilities – Commercialization Activities . The JCC shall perform the following functions, subject to the final decision-making process set forth in Section 4.6.4:

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(a) discuss and prepare the Commercialization Plan for Co-Co Product, including any amendments thereto;

(b) oversee implementation of the Commercialization Plan;

(c) review and coordinate the Commercialization activities of Celgene and Juno with respect to Co-Co Products, including pre-launch and post-launch activities in the North America Territory;

(d) review and comment on approaches and plans proposed by the Commercialization Lead Party in each applicable country and territory [***], in the North America Territory and the ROW Territory

(e) review and comment on approaches and plans proposed by the Commercialization Lead Party in the applicable territory [***], in the North America Territory and the ROW Territory;

(f) discuss any branding and/or co-branding matters;

(g) establish target numbers regarding reach and frequency of sales performance; (f) discuss and attempt to resolve any disputes in the JCC; and

(h) such other responsibilities as may be mutually agreed by the Parties from time to time. For purposes of clarity, the JCC shall not have any authority beyond the specific matters set forth in this Section 4.6.3, and in particular shall not have any power to amend, modify or waive the terms of this Agreement or any Development & Commercialization Agreement, or to alter, increase, expand or waive compliance by a Party with a Party’s obligations under this Agreement or any Development & Commercialization Agreement. In any case where a matter within the JCC’s authority arises, the JCC shall convene a meeting and consider such matter as soon as reasonably practicable, but in no event later than [***] after the matter is first brought to the JCC’s attention (or, if earlier, at the next regularly scheduled JCC meeting).

4.6.4. Decision-Making . The three (3) JCC representatives of each Party (or other number as agreed upon by the Parties pursuant to Section 4.6.2) will collectively have one (1) vote, and the JCC will make decisions only by unanimous consent of each Party with respect to its vote, and each Party will act reasonably in exercising its vote. Any matters unresolved by the JCC shall be submitted for resolution to the JSC. For the avoidance of doubt, the JCC will have no right to supervise or direct the Commercialization of Co-Co Candidates, Co-Co Products and Diagnostic Products and such activities shall be conducted by the Commercialization Lead Party for such Co-Co Candidates, Co-Co Products and Diagnostic Products, or as otherwise agreed between the parties.

4.6.5. Minutes . The Party who designates the chairperson of the JCC shall be responsible for preparing and circulating minutes of each meeting of the JCC, setting forth, inter alia, an overview of the discussions at the meeting and a list of any actions, decisions or

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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determinations approved by the JCC. Such minutes shall be effective only after such minutes have been approved by both Parties in writing. Definitive minutes of all JCC meetings shall be finalized no later than [***] after the meeting to which the minutes pertain.

4.7 Patent Committee.

4.7.1. Establishment . Within [***] after the Effective Date, the Parties shall establish the Patent Committee as more fully described in this Section 4.7. The Patent Committee shall facilitate the discussion and coordination of Patent Prosecution and Maintenance matters, in accordance with Article 7.

4.7.2. Meetings . The Patent Committee shall convene at such times, places and frequencies as the Patent Committee determines is necessary. The Patent Committee shall disband upon the expiration or termination of this and all Development & Commercialization Agreements in their entirety. Meetings of the Patent Committee that are held in person shall alternate between the offices of the Parties, or such other location as the Parties may agree. The members of the Patent Committee also may convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate. Each Party will bear all expenses it incurs in regard to participating in all meetings of the Patent Committee, including all travel and living expenses.

4.7.3. Membership . The Patent Committee shall be comprised of two (2) representatives (or such other number of representatives as the Parties may mutually agree) from each of Celgene and Juno. Each Party may replace any or all of its representatives on the Patent Committee at any time upon written notice to the other Party in accordance with Section 12.2. Each representative of a Party shall have sufficient seniority and expertise in the Prosecution and Maintenance of Patents to participate on the Patent Committee. Each Party may, subject to the other Party’s prior approval, invite non-member representatives of such Party to attend meetings of the Patent Committee as non-voting participants; provided, that any such representative is bound by obligations of confidentiality, non-disclosure and non-use consistent with those set forth herein prior to attending such meeting and provided, further, that such Third Party shall not have any voting or decision-making authority on the Patent Committee. [***] shall have the right to designate the initial chairperson of the Patent Committee, who shall serve for an initial term of one (1) year, and thereafter the selection of the chairperson shall alternate between the Parties every year. Each Party may replace any or all of its representatives on the Patent Committee at any time upon written notice to the other Party in accordance with Section 12.2.

4.7.4. General Responsibilities – Patent Activities . The Patent Committee shall perform the following functions, subject to the final decision-making process set forth in Section 4.7.6: (a) discuss ownership of Inventions and Patents thereon, in the event of a dispute in relation to the application of the terms of Section 7.2; (b) discuss material issues and provide input to each other regarding the Prosecution and Maintenance of Patents under this Agreement or any Development & Commercialization Agreement; (c) serve as a forum for exchanging information and facilitating discussions regarding patentability and freedom to operate assessments; and (d) perform such other responsibilities as may be mutually agreed by the Parties from time to time. The Patent Committee shall be responsible for coordinating the

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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implementation of each Party’s strategies for the protection of the foregoing intellectual property rights related to [***] developed for the foregoing. For clarity, the Patent Committee shall not have any authority beyond the specific matters set forth in this Section 4.7.4, and in particular shall not have any power to amend, modify or waive the terms of this Agreement or any Development & Commercialization Agreement, or to alter, increase, expand or waive compliance by a Party with, a Party’s obligations under this Agreement or any Development & Commercialization Agreement. In any case where a matter within the Patent Committee’s authority arises, the Patent Committee shall convene a meeting and consider such matter as soon as reasonably practicable, but in no event later than [***] after the matter is first brought to the Patent Committee’s attention (or, if earlier, at the next regularly scheduled Patent Committee meeting).

4.7.5. Minutes . The Party who designates the chairperson of the Patent Committee shall be responsible for preparing and circulating minutes of each meeting of the Patent Committee, setting forth, inter alia, an overview of the discussions at the meeting and a list of any actions, decisions or determinations approved by the Patent Committee. Such minutes shall be effective only after such minutes have been approved by both Parties in writing. Definitive minutes of all Patent Committee meetings shall be finalized no later than [***] after the meeting to which the minutes pertain.

4.7.6. Decisions .

(a) Decision Making . Except as otherwise provided in this Section 4.7.6, all decisions of the Patent Committee shall be made by consensus, with each Party having one (1) vote. If the Patent Committee cannot agree on a matter within the Patent Committee’s authority within [***] after it has met and attempted to reach such decision, then, either Party may, by written notice to the other, have such issue referred to the Executive Officers for resolution. The Parties’ respective Executive Officers shall meet within [***] after such matter is referred to them, and shall negotiate in good faith to resolve the matter. If the Executive Officers are unable to resolve the matter within [***], or such other longer timeframe the Executive Officers may otherwise agree upon, after the matter is referred to them in accordance with this Section 4.7.6(a), then the decision shall be resolved as set forth in Sections 4.7.6(b) and 4.7.6(c); provided, that the time periods set forth in this Section 4.7.6 may be shortened as necessary to prevent adversely affecting the interests of a Party in a material respect with respect to the Prosecution and Maintenance of the Patents described in Section 4.7.4.

(b) IP Ownership . The Patent Committee shall review and discuss ownership of Inventions and Patents thereon, specifically with respect to the application of the terms of Section 7.2; provided, that [***] with the terms of Section 7.2, so long as the Parties mutually agree to such [***]. In the event the Patent Committee cannot agree on a matter regarding ownership of an item of intellectual property, and Executive Officers are unable to resolve such matter, then either Party may submit such dispute to the courts in accordance with Section 12.7.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(c) Patent Prosecution . The Patent Committee shall discuss material issues and provide input to each Party regarding the Prosecution and Maintenance of Patents pursuant to this Agreement or any Development & Commercialization Agreement. The Patent Committee shall be responsible for coordinating the implementation of each Party’s strategies for the protection of the foregoing intellectual property rights related to Targets, Development Candidates, Products and Diagnostic Products Developed for the foregoing Products; provided, that both Parties may request the filing and prosecution of divisional Patent applications as set forth in Section 7.3.4(b) (the foregoing referred to herein as the “ Patent Strategy ”). All final decisions related to the Prosecution and Maintenance of any Patent pursuant to this Agreement or any Development & Commercialization Agreement shall be made by the Party with the right to control such Prosecution and Maintenance as set forth in Article 7.

(d) Additional Restrictions . Notwithstanding anything to the contrary in this Section 4.7.6, neither Party shall have the right to exercise its final decision-making authority to unilaterally: (i) determine that any obligations have been fulfilled under this Agreement or that a Party has breached any obligation under this Agreement or any Development & Commercialization Agreement; (ii) make a decision that is expressly stated to require the mutual agreement or mutual consent of the Parties; and (iii) otherwise expand a Party’s rights or reduce a Party’s obligations under this Agreement or any Development & Commercialization Agreement.

4.8 Exceptions to Decision-Making Authority.

4.8.1. [***] . Notwithstanding anything to the contrary in this Agreement or any Development & Commercialization Agreement, in no event shall the JSC or Patent Committee have any decision-making authority with respect to Patents covering or claiming the [***], the Prosecution and Maintenance, enforcement and defense of which shall, as between the Parties, remain solely with the Party Controlling such technology. For clarity, the foregoing does not restrict the determination of ownership of Inventions and Patents thereon [***] pursuant to Section 7.2.

4.8.2. [***] IP . Notwithstanding anything to the contrary in this Agreement or any Development & Commercialization Agreement, in no event shall the JSC or Patent Committee have any decision-making authority with respect to [***], the Prosecution and Maintenance, enforcement and defense of which shall, as between the Parties, remain solely with Celgene (with respect to [***] Patents) or Juno (with respect to [***] Patents). For clarity, the foregoing does not restrict the determination of ownership of Inventions and Patents thereon that would be deemed [***] Patents, as applicable, pursuant to Section 7.2.

4.8.3. [***] Products . Notwithstanding anything to the contrary in this Agreement or any Development & Commercialization Agreement, [***] shall not, by virtue of this Agreement or any Development & Commercialization Agreement, acquire any right to make any decision, whether through the JSC, Patent Committee or otherwise, regarding [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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ARTICLE 5

EXCLUSIVITY; [***]

5.1 Exclusivity.

5.1.1. General [***] Covenants .

(a) Subject to Section 5.3, commencing upon the Effective Date [***], except as expressly permitted in this Agreement or any Development & Commercialization Agreement, or mutually agreed in writing by the Parties, [***].

(b) Subject to Section 5.3, commencing upon the Effective Date and continuing until the expiration or earlier termination of [***], except as expressly permitted in this Agreement or any Development & Commercialization Agreement, or mutually agreed in writing by the Parties, neither [***]. Notwithstanding the foregoing, [***] shall not be deemed to have breached this Section 5.1.1 by way of any [***].

(c) Subject to Section 5.3, commencing upon the Effective Date and continuing until the expiration or earlier termination of [***], except as expressly permitted in this Agreement or any Development & Commercialization Agreement, or mutually agreed in writing by the Parties, [***]

 

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[***]. Without limiting the foregoing and subject to the immediately preceding sentence and subject to Section 5.3, and without limiting [***], commencing upon the Effective Date and continuing until the expiration or earlier termination of [***], except as expressly permitted in this Agreement or any Development & Commercialization Agreement, or mutually agreed in writing by the Parties, neither [***] nor its Affiliates shall [***], in a way that would [***]. Notwithstanding the foregoing, [***] shall not be deemed to have breached this Section 5.1.1(c) by way of [***] or the performance of [***].

(d) The foregoing provisions of this Section 5.1.1 shall be subject to the following exceptions:

(i) Sections 5.1.1(a), (b) and (c) shall apply until the earliest of (1) the expiration or termination of [***], (2) on [***] each Program, for such[***] such Program, (3) on [***] each Program, the expiration of [***] such Program, or (4) on [***] does not [***] for a [***] within the applicable [***].

(ii) Notwithstanding the foregoing, [***] shall have the right to [***], and to [***] (other than [***]) [***], so long as the [***].

 

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(iii) Furthermore, notwithstanding anything to the contrary in this Article 5, [***] for which [***], but not to [***], in each case in the [***], provided that [***] has complied with its obligations to provide to [***].

(iv) For avoidance of doubt, the [***] in this Section 5.1.1 shall not apply to [***] B-cell maturation antigen (“ BCMA ”).

(e) Notwithstanding anything to the contrary herein, solely with respect to [***], or an [***] does not exercise an Option [***] for a [***] such a [***], or (ii) if [***] declines a BD Option for a [***], within an Eligible BD Program that was [***] for such Eligible BD Program in accordance with Article 2 (either (i) or (ii), a “[***]”), [***] shall both be [***] under this Article 5, [***] within the [***], as applicable, but [***]; provided that on or before the date that is [***] after the [***] occurs, [***] may, at its sole discretion, elect to [***], as applicable, [***], by providing [***] with written notice [***], and provided further that unless the parties mutually agree otherwise, [***] of such [***] period after such [***].

(f) For purposes of this Section 5.1.1, references to [***] shall not be deemed to refer to [***].

5.1.2. General [***] Covenants .

(a) Subject to Section 5.3, commencing upon the Effective Date [***], neither [***] may [***] with respect to [***] that are [***].

 

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(b) Commencing upon the Effective Date and continuing until [***], except as expressly permitted in this Agreement or any Development & Commercialization Agreement, or mutually agreed in writing by the Parties, neither [***] may [***] that are (i) [***], or (ii) any [***] (other than [***]), but only to the extent that (1)[***], and/or (ii) if [***]; it being understood and agreed that in no event: (A) [***]; or (B) will any divesture required by Antitrust Law be deemed a breach of this Section 5.1.2.

For purposes of this Article 5, the following definitions have the following meanings: “[***] Product” means a [***] Development Candidate [***]. For clarity, [***] is not a “[***] Product. “[***] Component ” means any individual element of a Celgene Product ([***]); it being understood and agreed that such element is not [***] in and of itself. “[***] Reagent ” means [***] Products, or are intended for such purposes ([***]). For clarity, [***] Reagents may include agents present within a [***] Product [***].

(c) The restrictions in this Section 5.1.2 shall apply until [***] (i) the expiration or termination of [***], (ii) on an [***] each Program, for such [***] Products, in each case [***] in the case of item (1) [***], as applicable, until the [***] Option Exercise Window (or if a [***] for which no [***] Option Exercise Window was applicable, then [***]) for any such [***] Development Candidate or [***] Product, or (iii) on [***] each Program, the expiration of the period set forth in [***] such Program.

 

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(d) Notwithstanding anything to the contrary herein, solely with respect to [***], (i) if [***] does not exercise an Option [***] for a [***] such a [***], or (ii) if [***] declines a BD Option for a [***], within an Eligible BD Program that was [***] for such Eligible BD Program in accordance with Article 2 (either (i) or (ii), a “[***]”), [***] shall both be [***] within the [***], as applicable, but [***]; provided that on or before the date that is [***] after the [***] occurs, [***], may, at its sole discretion, elect to [***], as applicable, [***], by providing [***] with written notice [***], and provided further that unless the Parties mutually agree otherwise, [***] of such [***] period after such [***].

5.1.3. During the Research Collaboration Term, [***]. Moreover, during the Research Collaboration Term, [***] shall not [***] with respect to a [***] or otherwise that would result in [***] to Develop or Commercialize [***], provided that the foregoing shall not apply [***] to BCMA.

5.1.4. Notwithstanding anything to the contrary in this Agreement, [***] and its Affiliates shall have the right at all times to make, use, sell, offer for sale and otherwise exploit any and all products, which, for clarity, [***], and provide any and all services, that are in development or being Commercialized by its Affiliate [***] as of the Effective Date, without any payment or other obligation to [***] under this Agreement.

5.2 Post-Option . Subject to Section 5.3, on a Program-by-Program basis, commencing upon the date upon which a Party exercises its Option or BD Option with respect to a Program, which thereby becomes a Designated Program or a BD Designated Program and continuing thereafter:

 

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5.2.1. for [***], for [***] such Program, neither Party nor its Affiliates shall, except as expressly permitted in this Agreement or any Development & Commercialization Agreement, or mutually agreed in writing by the Parties: (a) [***] for such Program, or any [***], (b) [***], or (c) [***]; and

5.2.2. for [***] such Designated Program, until the earliest of (i) [***], (ii) [***] Option Exercise Window for such [***], (iii) [***] following the [***], or (iv) [***] a Development & Commercialization Agreement following the exercise of an Option for such [***], neither Party nor its Affiliates shall, except as expressly permitted in this Agreement or any Development & Commercialization Agreement, or mutually agreed in writing by the Parties: (a) [***] such Program, or [***], in a manner that would [***] or the obligation of [***], as provided in Section 3.1.5, or (b) [***],

provided that: (i) the foregoing in each of Sections 5.2.1 and 5.2.2 shall [***] following the exercise of an Option or BD Option for any Program, and (ii) notwithstanding the foregoing, for any [***] Program as applicable, and any [***] entered into by a Party [***], such Party and its Affiliates shall [***] that include (x) any[***] within such [***] such Program, or any [***], or (y) any [***] within such [***] such Program, or any [***], if, but only if, such [***] are included by such Party [***] for which Juno has an Option or BD Option, or as a Juno

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Program, [***] Program or BD Program for which Celgene has an Option or BD Option, as applicable, hereunder (subject to any applicable “hold separate” or divestitures required under Antitrust Laws).

5.3 Other Exceptions . Notwithstanding anything to the contrary contained herein, neither Party shall be deemed in breach of this Article 5 as follows:

5.3.1. Academic Collaborations . Notwithstanding the provisions of Section 5.1 and 5.2, each Party shall be permitted to perform any of the activities that would otherwise be prohibited under Section 5.1 or 5.2 in relation to a given Target, if such activities are (a) the subject of an existing agreement between such Party and an academic institution or academic collaborator entered into prior to the Effective Date, provided that such Party shall not be permitted to amend any such agreement unless such amendment contains provisions consistent with the terms and conditions of such agreement in effect as of the Effective Date with respect to (i) [***], or (b) the subject of a new agreement entered into between such Party and an academic institution or academic collaborator that contains terms and conditions with respect to the Academic Essential Provisions consistent with the terms and conditions of [***]; provided that if any [***] of an amendment described in (a) or an agreement described in (b) would not be [***] the agreements between such Party and an academic institution or academic collaborator entered into prior to the Effective Date, such Party [***].

5.3.2. Competitive Programs. Section 5.1 and 5.2 shall not apply if, during the [***], any Party or its Affiliates merges or consolidates with, or otherwise acquires, a Third Party that is then engaged in activities that would otherwise constitute a breach of this Article 5 by any Party or its Affiliates (a “ Competitive Program ”) or acquires by license or otherwise a Competitive Program from a Third Party; it being understood and agreed that, unless the Parties agree otherwise in writing, such Party that is engaged in a Competitive Program (the “ Competitive Program Party ”) shall, within [***] after the date of such merger, consolidation or acquisition, notify the other Party that it intends to either: (i) terminate, or cause its relevant Affiliate to terminate, the Competitive Program or (ii) divest, or cause its relevant Affiliate to divest, whether by license or otherwise, the Competitive Program. If the Competitive Program Party notifies the other Party within such[***] period that it intends to [***], such Competitive Program, the Competitive Program Party or its relevant Affiliate, shall (i) terminate such Competitive Program as quickly as possible, and in any event within [***] (unless applicable Law requires a longer termination period) after the Competitive Program Party delivers such notice to the other Party; and (ii) confirm to the other Party when such termination has been completed, and the Competitive Program Party’s

 

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continuation of the Competitive Program during such [***] (or, as required by applicable Law, longer) period shall not constitute a breach of the Competitive Program Party’s exclusivity obligations under Article 5. If the Competitive Program Party notifies the other Party within such [***] period that it intends to divest such Competitive Program, the Competitive Program Party or its relevant Affiliate shall use all reasonable efforts to effect such divestiture as quickly as possible, and in any event within [***] after the Competitive Program Party delivers such notice to the other Party, and shall confirm to the other Party when such divestiture has been completed. If the Competitive Program Party or its relevant Affiliate fails to complete such divestiture within such [***] period, but has used reasonable efforts to effect such divestiture within such [***] period, then, unless otherwise required by applicable Law, such [***] period shall be extended for such additional reasonable period thereafter as is necessary to enable such Competitive Program to be in fact divested, not to exceed an additional [***]; provided that such additional [***] period shall be extended for such period as is necessary to obtain any governmental or regulatory approvals required to complete such divestiture if the Competitive Program Party or its relevant Affiliate is using good faith efforts to obtain such approvals. The Competitive Program Party’s continuation of the Competitive Program during such divestiture period shall not constitute a breach of the Competitive Program Party’s exclusivity obligations under Article 5.

5.3.3. Certain Permitted Activities .

(a) The [***] shall not constitute a breach of Article 5. The [***] by either Party or its Affiliates and the performance by such Party or its Affiliates of any obligations thereunder shall not constitute a breach of Article 5; it being understood and agreed that [***] by either Party or any of its Affiliates shall be subject to Section 5.1 and Section 5.2.

(b) On a Program-by-Program basis, the restrictions set forth in Article 5 shall not be deemed to prevent either Party and its respective Affiliates from (a) fulfilling its obligations under this Agreement, or any Development & Commercialization Agreement with respect to such Program or any other Program and (b) engaging any subcontractors in accordance with Section 2.7 of this Agreement.

(c) On a Program-by-Program basis, if a Business Combination occurs with respect to either Party with a Third Party and the Third Party already is conducting or is planning to conduct activities that would cause a Party or an Affiliate to violate Article 5 (an “ Acquirer Program ”), then such Third Party [***]; provided, that (i) [***] in any Acquirer Program, (ii) [***] in any Acquirer Program, (iii) [***] in any such Acquirer Program, and (iv) [***]

 

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[***] to such Acquirer Program, including by [***] the activities under this Agreement, and the activities covered under such Acquirer Program (except that this requirement shall not apply to [***] activities under such Acquirer Program).

5.3.4. Rights in China Territory . Notwithstanding anything to the contrary in this Article 5, Juno retains all rights to Develop, Manufacture and Commercialize [***] Cellular Therapy Products in the China Territory.

5.4 Clinical Combinations. Notwithstanding anything in the contrary in this Agreement, [***] shall, at all times, have the right to conduct clinical Development of [***] Products, alone or with Third Parties, in which the [***]’s regulatory filings for purposes of enabling both [***] and such Third Party to include the relevant use of [***] Products in combination with such other therapeutic product in the approved label for such [***] Products and such other therapeutic product, provided that [***] does not grant to such Third Party the right to sell, offer for sale and otherwise commercially exploit such [***] Products. Notwithstanding anything to the contrary in this Agreement, [***] shall, at all times, have the right to conduct clinical Development of [***] Products, alone or with Third Parties, in which the [***] Products are used in combination with other therapeutic products, and to grant to any such Third Parties the right to use and reference [***]’s regulatory filings for purposes of enabling both [***] and such Third Party to include the relevant use of [***] Products in combination with such other therapeutic product in the approved label for such [***] Products and such other therapeutic product, provided that [***] does not grant to such Third Party the right to sell, offer for sale and otherwise commercially exploit such [***] Products.

5.5 [***] . At any time beginning on the Effective Date until the expiration of the Term or the earlier termination of the Agreement pursuant to Article 11 (the “[***] Term ”), [***] will have the [***] for each [***] that is subject to a Program for which [***] holds an unexercised and unexpired Option or a BD Option, or is subject to a Development & Commercialization Agreement (the “[***]”). Accordingly, [***] with any [***] shall notify [***] in writing [***] with a [***] for the purposes of [***], and [***] shall have [***] from the receipt of such notice (“ Notice of Interest Period ”) to provide [***] written notice (“ Notice of Interest ”) that it [***] with [***] regarding a [***]. If [***] gives a timely Notice of Interest, then the Parties shall [***] for a period of[***] (“ Negotiation Period ”).If [***] (i) gives notice that it [***], (ii) fails to give a timely Notice of Interest, or (iii) gives a timely Notice of Interest but [***]

 

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[***] prior to the expiration of the Negotiation Period, then [***] shall expire (the “[***] Expiration ”) and [***] shall be [***] under this Agreement with respect thereto, to [***] with any Third Party. Notwithstanding the foregoing, [***] may [***] without complying with this Section 5.5 for a period of [***].

As used in this Section 5.5, “[***]” means any [***] pursuant to which [***] intends to [***] with respect to the [***]; provided, however, that a [***] shall not include a [***].

ARTICLE 6

FINANCIAL TERMS

6.1 Upfront Payment. In consideration for the rights granted to Celgene under this Agreement, within [***] after the Effective Date, Celgene will make a total upfront payment to Juno of one hundred fifty million one hundred ninety six thousand five hundred and four U.S. Dollars ($150,196,504) in cash.

6.2 Research Expenses. As between the Parties, except as expressly set forth herein or otherwise agreed by the Parties, on a Program-by-Program basis until the exercise of the Option for a specific Program, (a) Juno shall be solely responsible for any and all costs and expenses it incurs in connection with the conduct of research and Development activities for Juno Programs, and (b) Celgene shall be solely responsible for any and all costs and expenses it incurs in connection with the conduct of research and Development activities for Celgene Programs.

6.3 Option Exercise Payments for Certain Programs.

6.3.1. CD19 Program . If Celgene exercises the Option for the CD19 Program, pursuant to Section 3.1.3, Celgene shall, within [***] after delivery of the Celgene Option Exercise Notice pay to Juno a one-time Option exercise fee in an amount equal to [***] if the Option Exercise Notice for the CD19 Program is delivered on or before the date which is [***] after the Original Execution Date, or [***] if the Option Exercise Notice is delivered thereafter. For the avoidance of doubt, if Celgene exercises its option for [***] with respect to the CD19 Program after a payment has been made pursuant to this Section 6.3.1, no additional payment shall be required under this Section 6.3.1 in connection with such exercise.

6.3.2. CD22 Program . If Celgene exercises the Option for the CD22 Program, pursuant to Section 3.1.3, Celgene shall, within [***] after delivery of the Celgene Option Exercise Notice, pay to Juno a one-time Option exercise fee in an amount equal

 

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to [***] if the Option Exercise Notice for the CD22 Program is delivered [***] for the CD22 Program, or [***] if the Option Exercise Notice is delivered thereafter. For the avoidance of doubt, if Celgene exercises its option for [***] with respect to the CD22 Program after a payment has been made pursuant to this Section 6.3.2, no additional payment shall be required under this Section 6.3.2 in connection with such exercise.

6.4 Designation Payments.

6.4.1. Designation Payment . With respect to all other Programs other than (a) the CD19 Program, (b) the CD22 Program (c) any [***] Program (which shall be subject to Section 6.5.3), or (d) any Eligible BD Program for which a Party delivers a BD Option Exercise Notice (which shall be subject to Section 2.2.1(c)), within [***] following the exercise of the Option by a Designating Party for each such Program pursuant to Section 3.1.3(b) or 3.1.3(c) the Designating Party shall pay to the Offering Party a designation payment (the “ Designation Payment ”) equal to [***] the Offering Party in [***] such Program, and in [***], prior to the exercise of the Option for such Program. The Designation Payment for each Program for which an Option is exercised shall be calculated [***] in accordance with the remainder of this Section 6.4, as the Designating Party shall elect in writing at the time it exercises the relevant Option. Notwithstanding the foregoing, neither Party shall be entitled to be reimbursed more than once for any elements of [***] for which such Party has previously been reimbursed.

6.4.2. Calculation of Designation Payment .

(a) The Designation Payment shall be equal to the [***] the Offering Party prior to the exercise of the Option in relation to [***] each Designated Program (other than the CD19 Program and the CD22 Program) multiplied by the Designation Percentage set forth in Table 1 below. The Designation Percentage shall be determined on a [***] by (i) for [***] such Designated Program, the percentage associated with [***] that resulted in the delivery of the Juno Option Exercise Notice, the Celgene Option Exercise Notice, or the [***] Option Exercise Notice, during the relevant Option Exercise Window, as applicable, pursuant to Section 3.1.3 (for any Juno Program or Celgene Program), or Section 3.1.5 (for any [***] Program), as set forth in Table 1 below, and (ii) for [***] such Designated Program, applying the percentage associated with the Data Package Trigger Event that [***], as set forth in Table 1 below, provided that if [***] in such [***] at the time of exercise of the Option, the Designation Percentage for [***] shall apply:

 

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Table 1: Calculation of Designation Payment.

 

Data Package Trigger Event

   Juno Program (other
than CD19 and CD22)
Designation Percentage
   Celgene Program
Designation Percentage

[***]

   [***]    [***]

[***]

   [***]    [***]

[***]

   [***]    [***]

[***]

   [***]    [***]

(b) Notwithstanding the foregoing:

(i) for any Option exercised by a Designating Party following the [***], the Designation Payment shall be calculated by multiplying the Designation Percentage for [***] the date of delivery of the Option Exercise Notice for such Program;

(ii) for any Option exercised for (A) any [***] Program that was (1) an [***] BD Program (as specified [***]) or (2) a [***] Program or a [***] Program (each as specified in Section [***]), or (B) any [***] Program that was (1) an [***] BD Program (as specified in Section [***]), or (2) a [***] Program (as specified in Section [***], the [***] such Program shall be deemed to be a component of [***], and for purposes of calculating the amounts due with respect thereto pursuant to the table above, such [***] shall be included in the calculation of the Designation Payment by [***]; and

(iii) for any Option exercised by a Party in relation to [***] Program offered by the other Party pursuant to Section 3.1.5(a), the Designation Payment shall be calculated by [***] as of the date of delivery of the Option Exercise Notice for such Program by the Designation Percentage that [***], or, in the case of any [***] Program for which the [***]. By way of example with respect to this subsection (iii), if the [***] Program is made available by [***], but during the conduct of [***] with respect to such [***] Internal Program, then the Designation Percentage shall be that applicable to [***] Data Package, or [***];

 

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provided that [***] the Designation Payment for any Program falling within subsection (ii) above [***], then the Parties shall negotiate an appropriate allocation of the [***] for such Program for a period of [***]. Such [***], as of the [***], and not [***]. In the event the Parties do not agree upon the [***] period, then the Parties shall [***]. The [***]. The Party seeking to exercise its Option for such [***] BD Program, [***] Program and/or [***] BD Program, as applicable, shall notify the other Party in writing within [***] following [***], whether such Party wishes to exercise its Option for such Program. For clarity, such Party shall have no obligation to proceed to exercise its Option under Sections 3.1.3 or 3.1.5 with respect to any Program falling within subsection (ii) above [***].

6.5 Designation Payment Structure . In the Juno Option Exercise Notice, Celgene Option Exercise Notice or [***] for a Program (as applicable), the Party exercising its Option for such Program shall also elect a structure for the payment to the other Party of the Designation Payment, from one of the two options set forth in Sections 6.5.1 and 6.5.2 below:

6.5.1. Designation Payment Structure A

(i) The Party exercising its Option for such Program shall pay to the Party offering such Program, within [***] following the delivery of the Celgene Option Exercise Notice, the Juno Option Exercise Notice, [***] as applicable, for such Program, an amount equal to the Designation Payment calculated in accordance with Section 6.4.2; and

(ii) Following the exercise of the Option for such Program, each Party would bear its share of all Post Option Costs incurred in connection with activities performed under the Development Plan for such Program following the exercise of the Option for such Program, in accordance with the relevant Development & Commercialization Agreement.

6.5.2. Designation Payment Structure B

(i) Alternatively, except with respect to an Option exercised for a Juno Program or [***] Program for which the Parties are required to

 

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enter into a License Agreement, the Party exercising its Option for such Program may [***], but in lieu of the paying Party’s bearing its allocated share of Post Option Costs under such Program following the exercise of the applicable Option pursuant to the relevant Development & Commercialization Agreement that such Party would otherwise bear, such Party would [***] pursuant to the applicable Development & Commercialization Agreement for such Program following the exercise of the Option, [***] for which such Party would have been responsible for bearing under the Profit & Loss Share pursuant to the applicable Development & Commercialization Agreement [***]; and

(ii) Following the payment in full of the Designation Payment under this Designation Payment Structure B, each Party would bear its share of all Post Option Costs incurred in connection with activities performed under the Development Plan for such Program, in accordance with the relevant Development & Commercialization Agreement.

6.5.3. [***] BD Opt-In Payment . Within [***] following a Party’s delivery of an [***] Option Exercise Notice with respect to any [***] BD Program, the Party exercising the Option shall pay to the other Party a lump sum payment equal to [***] incurred by the Offering Party in relation to such [***] BD Program prior to such date (the “[***] BD Opt-In Payment ”), [***]. [***], if [***] included in the calculation of the [***] BD Opt-In Payment include any [***] then the Parties shall [***] BD Program for a period of [***]. In the event the Parties [***] as promptly as practicable [***]. The Party seeking to exercise its Option for such [***] BD Program shall notify the other Party in writing within [***] following [***], whether such Party wishes to exercise its Option for such [***] BD Program. For clarity, such Party shall have no obligation to proceed to exercise its Option with respect to any [***] BD Program for which [***].

6.6 Additional Payment Terms.

 

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6.6.1. Accounting . All payments hereunder shall be made in the United States in U.S. Dollars by wire transfer to a bank in the U.S. designated in writing by Juno.

6.6.2. Late Payments . Any payments or portions thereof due hereunder that are not paid on the date such payments are due under this Agreement shall bear interest at an annual rate equal to the lesser of: (a) [***], or any successor thereto, at 12:01 a.m. on the first day of each Calendar Quarter in which such payments are overdue or (b) the maximum rate permitted by applicable Law; in each case calculated on the number of days such payment is delinquent, compounded monthly.

6.6.3. No Multiple Payments . The Parties understand and agree that (a) in calculating [***] for the purpose of calculating the Designation Payment, costs and expenses that have been previously paid by the Party making such Designation Payment shall not be included in the calculation of any subsequent Designation Payment made by such Party, and (b) there shall be only one royalty payment due pursuant to the License Agreement with respect to the sale of any given unit of a Product.

6.7 Tax Withholding.

6.7.1. Tax Withholding .

(a) Each Party shall be entitled to deduct and withhold from any amounts payable under this Agreement or any License Agreement such taxes as are required to be deducted or withheld therefrom under any provision of applicable Law. The Party that is required to make such withholding (the “ Paying Party ”) will: (i) deduct those taxes from such payment, (ii) timely remit the taxes to the proper taxing authority, and (iii) send evidence of the obligation together with proof of tax payment to the recipient Party (the “ Payee Party ”) on a timely basis following that tax payment; provided, however, that before making any such deduction or withholding, the Paying Party shall give the Payee Party notice of the intention to make such deduction or withholding (such notice, which shall include the authority, basis and method of calculation for the proposed deduction or withholding, shall be given at least a reasonable period of time before such deduction or withholding is required, in order for such Payee Party to obtain reduction of or relief from such deduction or withholding). Each Party agrees to cooperate with the other Parties in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect to ensure that any amounts required to be withheld pursuant to this Section 6.7.1 are reduced in amount to the fullest extent permitted by applicable Laws. In addition, the Parties shall cooperate in accordance with applicable Laws to minimize [***] in connection with this Agreement or a License Agreement, as applicable.

(b) The Parties acknowledge and agree that [***] (and its Affiliates) will not, absent a change in Law or relevant circumstance between the date of this Agreement and the Effective Date, deduct or withhold from the amounts payable pursuant to Section 6.1 any amount in respect of any taxes provided that [***] provides [***] with a properly completed and duly executed IRS Form W-9.

 

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(c) In the event that a liability is imposed by a taxing authority upon [***] in respect of a failure to withhold on an amount payable pursuant to Section 6.7.1(b) (except to the extent that, if [***] had withheld on such amounts, it would have been required to gross-up with respect to such amounts under Section 6.7.2), then [***] shall indemnify and hold harmless [***] from any and all liabilities, claims and losses with respect to such failure to withhold, provided that (i) [***] shall notify [***] promptly upon the receipt of any claim from a taxing authority which might give rise to an indemnification under this Section 6.7.1(c) (although [***] delay in promptly notifying [***] shall only reduce [***]’s liability to indemnify [***] to the extent that [***] is prejudiced by such delay); (ii) [***] shall be entitled to participate, at its own expense, and with counsel of its choosing, in the defense of any claim which may give rise to liability under this Section; and (iii) [***] may not settle any liability with a Taxing Authority, to the extent such settlement would create a liability for [***] under this Section 6.7.1(c) without the prior written consent of [***], which consent will not be unreasonably withheld, conditioned or delayed.

6.7.2. Tax [***] . Notwithstanding the foregoing, if (a) any Party [***], (b) as a result of [***], such Party [***], and (c) [***] (i) [***] or (ii) [***]. To the extent [***]. The foregoing sentence shall not [***].

 

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Furthermore, [***]. Solely for purposes of this Section 6.7.2, (A) [***] and (B) [***].

6.7.3. Tax Documentation . Each Party has provided a properly completed and duly executed IRS Form W-9 or applicable Form W-8 to the other Parties. Each Party and any other recipient of payments under this Agreement shall provide to the other Party, at the time or times reasonably requested by such other Parties or as required by applicable Law, such properly completed and duly executed documentation (for example, IRS Forms W-8 or W-9) as will permit payments made under this Agreement to be made without, or at a reduced rate of, withholding for taxes.

6.7.4. Withholding Indemnity . In the event that a liability is imposed by a taxing authority upon a Paying Party in respect of a failure to withhold U.S. federal withholding tax (for which tax no additional amounts are or would have been required to be paid by the Paying Party under Section 6.7.2) in respect of any payment or deemed payment to a non-U.S. Payee Party under this Agreement or any License Agreement, such non-U.S. Payee Party shall indemnify and hold the Paying Party harmless from any and all liabilities, claims and losses with respect to such failure to withhold U.S. federal withholding taxes, provided that such non-U.S. Payee Party shall be entitled to the same notification, participation, consent and other rights afforded Juno under clauses (i) through (iii) of Section 6.7.1(c).

6.7.5. Cooperation . Celgene and Juno shall use commercially reasonable efforts to cooperate with each other to minimize any adverse tax consequences that may arise with regard to the transactions contemplated by this Agreement and related agreements, including furnishing to the other Party, as promptly as practicable, information regarding a non-U.S. Affiliate’s tax profile and operating activities as is reasonably requested by the other Party.

ARTICLE 7

INTELLECTUAL PROPERTY

7.1 Licenses.

7.1.1. License to Celgene .

(a) On a Program-by-Program basis, commencing on the Effective Date and extending until expiration of the applicable Option Term, subject to the terms and on the conditions set forth in this Agreement, Juno hereby grants and shall cause (within [***] after the Effective Date) its Affiliates to grant to Celgene (i) a non-exclusive, worldwide, royalty-free right and license, with the right to grant sublicenses (subject to Section 7.1.4(a)), under the Juno IP (including any Collaboration IP solely owned by Juno and/or its Affiliates) and Juno’s and its Affiliates’ interest in the Joint Collaboration IP, solely to permit Celgene to conduct its

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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activities or perform its responsibilities with respect to each Program that is subject to a Juno Option, a BD Option exercisable by Juno or an Option exercisable by Juno under Section 3.1.5, and (ii) a non-exclusive, worldwide, royalty-free right and license, with the right to grant sublicenses [***] (subject to Section 7.1.4(a)), under Patents and Know-How Controlled by Juno and/or its Affiliates Covering or claiming the [***], solely to permit Celgene to conduct its activities or perform its responsibilities with respect to each Program that is subject to a Juno Option, a BD Option exercisable by Juno, or an Option exercisable by Juno under Section 3.1.5.

(b) Subject to the terms and on the conditions set forth in this Agreement, Juno hereby grants and shall cause (within [***] after the Effective Date) its Affiliates to grant to Celgene a non-exclusive, irrevocable, perpetual, worldwide, royalty-free license (with the right to sublicenses solely as provided in Section 7.1.4(a)), under any [***] Patents [***], to make, have made, use, sell, offer for sale, import and otherwise exploit any and all products and services (except that this license shall not include any right to make or have made [***]). For the avoidance of doubt, [***]. During the term of this Agreement, [***]. This [***]. For the purposes of this Section 7.1.1(b), “[***].

(c) Subject to the terms and on the conditions set forth in this Agreement, Juno hereby grants and shall cause (within [***] after the Effective Date) its Affiliates to grant to Celgene a non-exclusive, irrevocable, perpetual, worldwide, royalty-free license, with the right to sublicense [***], under [***]. If Juno or any of its Affiliates has [***].

7.1.2. License to Juno .

(a) On a Program-by-Program basis, commencing on the Effective Date and extending until expiration of the applicable Option Term subject to the terms and on the conditions set forth in this Agreement, Celgene hereby grants and shall cause (within [***] after the Effective Date) its Affiliates to grant to Juno (i) a non-exclusive, worldwide, royalty-free right and license, with the right to grant sublicenses (subject to Section 7.1.4(b)), under the Celgene IP (including any Collaboration IP solely owned by Celgene and/or its

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Affiliates) and Celgene’s and its Affiliates’ interest in the Joint Collaboration IP, solely to permit Juno to conduct its activities or perform its responsibilities with respect to each Program that is subject to a Celgene Option, a BD Option exercisable by Celgene or an Option exercisable by Celgene under Section 3.1.5, and (ii) a non-exclusive, worldwide, royalty-free right and license, with the right to grant sublicenses [***] (subject to Section 7.1.4(b)), under Patents and Know-How Controlled by Celgene and/or its Affiliates Covering or claiming the [***], solely to permit Juno to conduct its activities or perform its responsibilities with respect to each Program that is subject to a Celgene Option, a BD Option exercisable by Celgene or an Option exercisable by Celgene under Section 3.1.5.

(b) Subject to the terms and on the conditions set forth in this Agreement, Celgene hereby grants and shall cause (within [***] after the Effective Date) its Affiliates to grant to Juno a non-exclusive, royalty-free right and license, with the right to grant sublicenses [***], under any Collaboration IP solely owned by Celgene and/or its Affiliates and Celgene’s and/or its Affiliates’ interest in the Joint Collaboration IP, to make, have made, use, sell, offer for sale, import and otherwise exploit Cellular Therapy Development Candidates, Cellular Therapy Products, and Cellular Therapy Regulatory Compounds for use therewith, in the Field in the China Territory. The Parties [***]. If the Parties agree that [***].

(c) Subject to the terms and on the conditions set forth in this Agreement, Celgene hereby grants and shall cause (within [***] after the Effective Date) its Affiliates to grant to Juno a non-exclusive, irrevocable, perpetual, worldwide, royalty-free license (with the right to sublicense [***]), under any [***] Patents [***], to make, have made, use, sell, offer for sale, import and otherwise exploit any and all products and services ([***]). During the term of this Agreement, [***]. This [***]. For the purposes of this Section 7.1.2(c), [***].

(d) Subject to the terms and on the conditions set forth in this Agreement, Celgene hereby grants and shall cause (within [***] after the Effective Date) its Affiliates to grant to Juno an exclusive license (subject only to the extent set forth below in this Section 7.1.2(d)), with the right to sublicense [***], under [***]

 

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[***]. If Celgene or any of its Affiliates has [***]. Notwithstanding the foregoing, Celgene [***]; and (ii) to grant non-exclusive licenses to Third Party subcontractors engaged by Celgene in accordance with Section 2.7, provided that [***].

(e) Subject to the terms and on the conditions set forth in this Agreement, Celgene hereby grants and shall cause (within [***] after the Effective Date) its Affiliates to grant to Juno a nonexclusive license (with the right to sublicense through multiple tiers), under [***]. If Celgene or any of its Affiliates has [***].

7.1.3. Additional Licenses . Each Development & Commercialization Agreement will specify additional licenses granted by each Party to the other Party for the research, Development, Manufacture and/or Commercialization of [***] Agents [***] for the Programs that are subject to such agreements that are within [***] for such Programs.

7.1.4. Sublicenses .

(a) Celgene shall have the right to grant sublicenses under the rights granted to it under Section 7.1.1(a)(i) [***], and under Sections 7.1.1(a)(ii) and 7.1.1(b), [***], provided that the foregoing restrictions on [***] shall terminate upon the expiration or termination of the Research Collaboration Term.

(b) Juno shall have the right to grant sublicenses under the rights granted to it under Sections 7.1.2(a)(i) [***], and under Section 7.1.2(a)(ii) [***].

 

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(c) Each sublicense granted by either Party under Section 7.1.4(a) or 7.1.4(b) shall be subject to and consistent with the terms and conditions of this Agreement.

7.1.5. Rights Retained by the Parties . For purposes of clarity, each Party retains all rights under Know-How and Patents Controlled by such Party not expressly granted to the other Party pursuant to this Agreement.

7.1.6. No Implied Licenses . Except as explicitly set forth in this Agreement, neither Party shall be deemed by estoppel, implication or otherwise to have granted the other Party any license or other right to any intellectual property of such Party.

7.1.7. Section 365(n) of the Bankruptcy Code . All licenses granted under this Agreement are deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as defined in Section 101 of such Code. Each Party, as licensee, may fully exercise all of its rights and elections under the Bankruptcy Code. The Parties further agree that, if a Party elects to retain its rights as a licensee under any Bankruptcy Code, such Party shall be entitled to complete access to any technology licensed to it hereunder and all embodiments of such technology. Such embodiments of the technology shall be delivered to the licensee Party not later than: (a) the commencement of bankruptcy proceedings against the licensor, upon written request, unless the licensor elects to perform its obligations under the Agreement, or (b) if not delivered under clause (a), upon the rejection of this Agreement by or on behalf of the licensor, upon written request. Any agreements supplemental hereto will be deemed to be “agreements supplementary to” this Agreement for purposes of Section 365(n) of the Bankruptcy Code. As used herein, “ Bankruptcy Code ” means the U.S. Bankruptcy Code and any foreign equivalent thereto in any country having jurisdiction over a Party or its assets.

7.2 Ownership.

7.2.1. Inventions . Inventorship of Inventions shall be determined by application of U.S. patent law pertaining to inventorship.

7.2.2. Background IP . As between the Parties, Celgene will retain all right, title and interest in and to the Celgene Background IP and Juno will retain all right, title and interest in and to the Juno Background IP, except, in each case, to the extent that any such rights are expressly licensed by one Party to the other Party under this Agreement or any Development & Commercialization Agreement.

7.2.3. General . As between the Parties, and except as otherwise provided in Sections 7.2.4 and 7.2.5: (a) each Party shall solely own all Inventions and intellectual property rights therein that are Collaboration IP designed, discovered, generated, invented or conceived by or on behalf of such Party and/or its Affiliates, whether solely or jointly with any Third Party, but not jointly by or on behalf of the other Party or such other Party’s respective Affiliates and (b) both Parties shall jointly own all Inventions and intellectual property rights therein that are designed, discovered, generated, invented or conceived jointly by or on behalf of both Parties and/or their respective Affiliates (“ Joint Collaboration IP ”), such that, as between the Parties

 

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(including any respective Affiliates), each Party and/or its respective Affiliates has an undivided joint interest in such Joint Collaboration IP, and subject to Section 7.1.4 and subject to any assignment of rights or licenses granted by one Party and/or its Affiliates to the other Party and/or its Affiliates under this Agreement or any Development & Commercialization Agreement, shall have no duty of accounting to the other Party and/or its Affiliates and no requirement to obtain consent from the other Party and/or its Affiliates in connection with any licenses granted by either Party and/or its Affiliates to Third Parties with respect to such Joint Collaboration IP or the enforcement of such Joint Collaboration IP.

7.2.4. Assignment to Juno . Notwithstanding Section 7.2.3, Celgene shall assign, and shall cause (within [***] after the Effective Date) its Affiliates to assign, and hereby assigns to Juno, effective upon issuance, all of Celgene’s interest in any [***] and in any [***], if either: (a) the Parties have agreed, in any Collaboration Material Transfer Agreement, that Celgene will assign its interest, or (b) [***]. For clarity, unless otherwise agreed or provided in this Section 7.2, in no event shall Celgene or its Affiliates be required to assign to Juno a Patent [***].

7.2.5. Assignment to Celgene . Notwithstanding Section 7.2.3, Juno shall assign, and shall cause (within [***] after the Effective Date) its Affiliates to assign, and hereby assigns to Celgene, effective upon issuance, all of Juno’s interest in any [***] and in any [***], if either (a) the Parties have agreed, in any Collaboration Material Transfer Agreement, that Juno will assign its interest, or (b) [***]: (A) are [***] and (B) are [***], and (ii) any [***]. For the purposes of this Section 7.2.5, a [***]. For clarity, unless otherwise agreed or provided in this Section 7.2, in no event shall Juno or its Affiliates be required to assign to Celgene [***].

7.2.6. Other Assignments; Dispute Resolutions as to Assignments . The Patent Committee may recommend to the JSC assignment of Patents within any [***] Patents, [***] Patents and Joint Collaboration IP that is not otherwise assigned by

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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one Party to the other Party pursuant to Sections 7.2.4 or 7.2.5. If the Parties are unable to agree whether the criteria set out in Sections 7.2.4 or 7.2.5 for assignment of Patents by one Party to the other Party has been met, such matter shall be referred to the JSC for resolution pursuant to the process set forth in Section 4.2.5. Notwithstanding anything to the contrary in Section 4.2.5, if following escalation, the Parties’ respective Executive Officers are unable to resolve the matter within [***] or such longer timeframe as the Executive Officers may agree upon, then the matter in dispute shall be referred for resolution pursuant to Section 12.8.2(b).

7.2.7. Cooperation . For any Invention which, in accordance with Section 7.2, is to be assigned by one Party (the “ Assignor Party ”) to the other Party (“ Assignee Party ”), the Assignor Party shall (i) cause its Affiliates, employees, consultants, sublicensees (and Sublicensees), agents, and/or independent contractors to disclose to such Assignor Party, the design, discovery, generation, invention or conception of any such Invention, (ii) promptly disclose such design, discovery, generation, invention, or conception of any such Invention to the Assignee Party, (iii) cause such Affiliates, employees, consultants, sublicensees (and Sublicensees), agents, and independent contractors to assign to such Assignor Party, such person’s or entity’s right, title and interest in and to any such Inventions, and intellectual property rights therein, as is necessary to enable such Assignor Party to fully assign the ownership of such Inventions, and intellectual property rights therein, as provided for in Sections 7.2.3, 7.2.4 and 7.2.5 (as relevant), and (iv) effect assignment of such Assignor Party’s full rights, title, and interest, in and to such Inventions, and intellectual property rights therein, to the Assignee Party. Each Party shall also include provisions in its relevant agreements with Third Parties performing activities on its behalf pursuant to this Agreement and any Development & Commercialization Agreement, that effect the intent of this Section 7.2. Each Party agrees to provide reasonable cooperation to the other Party, and shall cause its Affiliates, employees, consultants, sublicensees, agents, and independent contractors to cooperate with the other Party and take all reasonable additional actions and execute such agreements, instruments and documents as may be reasonably required to perfect such other Party’s right, title and interest in and to Inventions, and intellectual property rights therein, as set forth in this Section 7.2, including by executing and delivering all documents reasonably required to evidence or record any assignment pursuant to this Agreement or any Development & Commercialization Agreement.

7.2.8. Allocation . Notwithstanding Sections 7.2.1 through 7.2.5, inclusive, and subject to Section 7.2.6, the Patent Committee [***]. Any such proposal by the Patent Committee shall not be effective unless and until the Parties mutually agree in writing to such allocation.

7.3 Prosecution and Maintenance of Patents.

7.3.1. Patents Owned by One Party . Except as otherwise provided by this Article 7 or mutually agreed in writing between the Parties, each Party (as between such Party and the other Party) shall have the first right (but not the obligation) to Prosecute and Maintain, in the Territory, all Patents that are solely owned or Controlled (other than by way of this Agreement)

 

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by such Party and/or its Affiliates. Subject to Sections 7.7 and 7.8, as between the Parties, (a) Juno shall have the first right (but not the obligation) to Prosecute and Maintain in the Territory Juno Patents, and (b) Celgene shall have the first right (but not the obligation) to Prosecute and Maintain in the Territory Celgene Patents. As between the Parties, (a) Juno shall have the sole right (but not the obligation) to Prosecute and Maintain in the Territory all Patents Covering the [***], and (b) Celgene shall have the sole right (but not the obligation) to Prosecute and Maintain in the Territory all Patents Covering the [***].

7.3.2. Joint Collaboration Patents .

(a) Subject to Section 7.3.2(b), as between the Parties, the Patent Committee shall determine which Party shall have the first right (but not the obligation) to Prosecute and Maintain the Patents within the Joint Collaboration IP (“Joint Collaboration Patents”), based on [***]. The Party selected to have the right to Prosecute and Maintain such a Joint Collaboration Patent shall be the “Selected Party.”

(b) Notwithstanding the foregoing in Section 7.3.2(a), except as otherwise provided or mutually agreed by the Parties, (i) [***] shall have the right (but not the obligation) to Prosecute and Maintain [***], and (ii) [***] shall have the right (but not the obligation) to Prosecute and Maintain [***] Patents [***].

7.3.3. Other Allocation of Prosecution and Maintenance Rights . The Patent Committee may recommend that the right to Prosecute and Maintain a [***] Patent, a [***] Patent, or a Joint Collaboration Patent in a manner other than as provided under Section 7.3.2(a) and 7.3.2(b), such recommendation to take effect only upon mutual agreement by the Parties. To the extent that a Patent application to be filed after the Original Execution Date comprises subject matter [***] without the mutual agreement of the Parties. If [***].

7.3.4. Communication and Cooperation .

(a) Juno shall (i) keep Celgene informed as to material developments with respect to the Prosecution and Maintenance of Patents for which Juno controls Prosecution and Maintenance, [***], including by providing copies of all

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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substantive office actions or any other substantive documents in connection with such Patents that Juno receives from any patent office, including notice of all interferences, reissues, oppositions or requests for patent term extensions, and (ii) provide Celgene with a reasonable opportunity to comment substantively on the Prosecution and Maintenance of such Patents, prior to taking material actions (including the filing of initial applications), and will in good faith consider any comments made by and actions recommended by Celgene, provided however that Celgene does so promptly and consistently with any applicable filing deadlines. Juno shall not be required under this Agreement to inform, provide information on or an opportunity to comment to Celgene with respect to [***].

(b) Celgene shall (i) keep Juno informed as to material developments with respect to the Prosecution and Maintenance of Patents for which Celgene controls Prosecution & Maintenance, [***] including by providing copies of all substantive office actions or any other substantive documents in connection with such Patents that Juno receives from any patent office, including notice of all interferences, reissues, oppositions or requests for patent term extensions, and (ii) provide Juno with a reasonable opportunity to comment substantively on the Prosecution and Maintenance of such Patents, prior to taking material actions (including the filing of initial applications), and will in good faith consider any comments made by and actions recommended by Juno, provided however that Juno does so promptly and consistently with any applicable filing deadlines. Celgene shall not be required under this Agreement to inform, provide information on or an opportunity to comment to Juno with respect to any [***].

7.3.5. Back-Up Right .

(a) If Juno decides not to file (or intends to allow to become abandoned without first filing a continuing or substitute Patent) a Juno Patent or Collaboration Patent (other than a [***]) that Juno has the right to Prosecute and Maintain and that [***], Juno shall notify and consult with Celgene of such decision or intention at least [***] prior to the date of a public disclosure, filing deadline, or other event after which patentability of the subject matter could be substantially impaired, or after which such Patent shall become abandoned. Celgene shall thereupon have the right (but not the obligation) to assume the Prosecution and Maintenance thereof at Celgene’s expense with counsel of its choice.

(b) If Celgene decides not to file (or intends to allow to become abandoned without first filing a continuing or substitute Patent) a Celgene Patent or Collaboration Patent (other than a [***]) that Celgene has the right to Prosecute and Maintain and that [***]

 

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[***], Celgene shall notify and consult with Juno of such decision or intention at least [***] prior to the date of a public disclosure, filing deadline, or other event after which patentability of the subject matter could be substantially impaired, or after which such Patent shall become abandoned. Juno shall thereupon have the right (but not the obligation) to assume the Prosecution and Maintenance thereof at Juno’s expense with counsel of its choice.

7.3.6. New Applications . For any subject matter to which a Patent has not yet [***], the Party having the right to Prosecute and Maintain Patents directed to such subject matter pursuant to Section 7.3.1(a) (unless such Party has elected not to exercise such right, pursuant to Section 7.3.5) shall, where possible, file new patent applications (each, a “ New Prosecution Patent ”) on such subject matter and shall Prosecute and Maintain Patents with respect to such New Prosecution Patents in every country or jurisdiction listed in Schedule 7.3.6(c) (the “ Core Countries ”), within the period of time permitted for effecting such filing in each respective Core Country. If the other Party wishes to Prosecute and Maintain such Patent in countries other than the Core Countries, it may [***] the Party [***]. Following such Party’s [***], such Party [***] such Patent [***], and [***] shall [***] in connection with the Prosecution and Maintenance [***].

7.3.7. Prosecution and Maintenance of Third Party Patents .

(a) Notwithstanding Section 7.3.1, Celgene acknowledges that the counterparties to the Juno Upstream Agreements may have the first right to prosecute and maintain the Patents licensed to Juno pursuant to such Juno Upstream Agreements (the “ Juno Upstream Agreement Patents ”). If such counterparty decides to refrain from or to cease prosecuting or maintaining the Juno Upstream Agreement Patents, then under the relevant Juno Upstream Agreement, Juno may have the right to continue such prosecution or maintenance. If Juno continues such activities, then Juno shall proceed as provided in this Section 7.3 with respect to the Juno Upstream Agreement Patents, subject to any obligations of Juno to any Third Party licensees with respect to the Juno Upstream Agreement Patents; provided that Celgene agrees and acknowledges that Juno may be obligated to provide to such counterparty any and all draft filings and applications for the Juno Upstream Agreement Patents, as well as responses to patent authorities in connection therewith, before filing such items, for review and comment by such counterparty.

(b) Notwithstanding Section 7.3.1, Juno acknowledges that the counterparties to the Celgene Upstream Agreements may have the first right to prosecute and maintain the Patents licensed to Celgene pursuant to such Celgene Upstream Agreements (the “ Celgene Upstream Agreement Patents ”). If such counterparty decides to refrain from or to cease prosecuting or maintaining the Celgene Upstream Agreement Patents, then under the relevant Celgene Upstream Agreement, Celgene may have the right to continue such prosecution or maintenance. If Celgene continues such activities, then Celgene shall proceed as provided in this

 

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Section 7.3 with respect to the Celgene Upstream Agreement Patents, subject to any obligations of Celgene to any Third Party licensees with respect to the Celgene Upstream Agreement Patents; provided that Juno agrees and acknowledges that Celgene may be obligated to provide to such counterparty any and all draft filings and applications for the Celgene Upstream Agreement Patents, as well as responses to patent authorities in connection therewith, before filing such items, for review and comment by such counterparty.

7.3.8. Cooperation in Prosecution and Maintenance .

(a) Each Party agrees to make its employees, agents and consultants reasonably available to the other Party (or to the other Party’s authorized attorneys, agents or representatives), [***], and shall assist in any license registration processes with applicable Governmental Authorities that may be available for the protection of a Party’s interests in this Agreement or any Development & Commercialization Agreement. In the event of any termination of a Party’s license rights under this Agreement or any Development & Commercialization Agreement, the Party with a license registration related to such terminated license rights shall promptly cooperate with any request by the other Party to terminate any such registration relating to the terminated license rights.

(b) The Parties shall reasonably cooperate with one another, through the Patent Committee and their respective Patent Liaisons, to file and prosecute the Patents, for which either Party is responsible for Prosecution and Maintenance pursuant to this Section 7.3. At either Party’s reasonable request, the Parties shall reasonably cooperate with one another to file and prosecute continuing or divisional Patent applications with respect to Juno Patents, Joint Collaboration Patents and Celgene Patents, in each case that are [***], or [***].

7.3.9. Costs of Prosecution and Maintenance . Each Party shall be responsible for all costs and expenses associated with its Prosecution and Maintenance activities under Section 7.3 with respect to Patents for which it is responsible pursuant to Sections 7.3.1 or 7.3.2, as applicable, except that the Parties shall share equally all costs and expenses of Prosecuting and Maintaining Joint Collaboration Patents.

7.4 Defense of Claims Brought by Third Parties . If a Party becomes aware of any actual or potential claim that the research, Development, Manufacture or Commercialization of any [***] being researched, Developed, Manufactured or Commercialized pursuant to this Agreement (and that is the subject of a Juno Option, Celgene Option, a BD Option or an Option exercisable under Section 3.1.5) infringes or misappropriates the intellectual property rights of any Third Party, such Party shall [***]. Certain additional rights and obligations of the Parties with respect to any such claim will be set forth in the Development & Commercialization Agreement for such Program (in each case, if applicable).

 

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7.5 Enforcement of Patents Prior to Exercise of Option.

7.5.1. Notice . If any Party learns of an infringement or threatened infringement by a Third Party of any [***], by reason of the manufacture, use or sale of a [***], or product constituting, incorporating, comprising, made using or containing [***], or any such Patent is challenged in any action or proceeding relating to any [***] or product (including by way of any inter partes review proceedings or reexaminations, but excluding any oppositions, cancellations, interferences or reissue proceedings, which are addressed above under the rules for Prosecution and Maintenance), in each case that is the subject of a Juno Option, Celgene Option, a BD Option or an Option exercisable under Section 3.1.5, such Party shall [***] and shall [***] and following such [***].

7.5.2. Enforcement and Defense of Juno Patents . As between the Parties, unless otherwise explicitly provided under a Development & Commercialization Agreement [***], Juno shall have the sole right, but not the obligation, to institute, prosecute, and control any action or proceeding with respect to any infringement or Defense of any Juno Patent, [***], by counsel of its own choice, in Juno’s own name and under Juno’s direction and control. In no event shall Celgene have the right to enforce or Defend Patents solely Covering or claiming Juno Platform Technology.

7.5.3. Enforcement and Defense of Celgene Patents . As between the Parties, unless otherwise explicitly provided under a Development & Commercialization Agreement [***], Celgene shall have the sole right, but not the obligation, to institute, prosecute, and control any action or proceeding with respect to any infringement or Defense of any Celgene Patent [***], by counsel of its own choice, in Celgene’s own name and under Celgene’s direction and control. In no event shall Juno have the right to enforce or Defend Patents [***].

7.5.4. Enforcement and Defense of Joint Collaboration Patents . Promptly after notice under Section 7.5.1 with respect to a Joint Collaboration Patent, the Parties shall meet to discuss whether they wish to enforce or Defend such Patent. Absent agreement within twenty (20) days and notwithstanding anything to the contrary herein, each Party shall have the right to enforce or Defend such Patent.

 

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7.5.5. Settlement . A settlement or consent judgment or other voluntary final disposition of an action or proceeding under this Section 7.5 may be entered into without the consent of the Party not bringing or Defending such action or proceeding; provided, however, that any such settlement, consent judgment or other disposition of any action or proceeding by a Party under this Section 7.5 shall not, without the consent of the Party not bringing or Defending such action or proceeding, (a) [***] the Party not bringing or Defending such action or proceeding, (b) include [***] the Party not bringing or Defending such action or proceeding [***], (c) [***] the Party not bringing or Defending such action or proceeding, or (d) [***] the Party not bringing or Defending such action or proceeding [***].

7.5.6. Joinder . In the case of any action or proceeding in accordance with this Section 7.5, at the enforcing Party’s written request, and at such enforcing Party’s expense (subject to Section 7.5.9), the other Party will join any such action or proceeding as a party and will use Commercially Reasonable Efforts to cause any Third Party as necessary to join such action or proceeding as a party if doing so is necessary for the purposes of establishing standing or is otherwise required by applicable Law to pursue such action or proceeding.

7.5.7. Cooperation . In addition to the obligations set forth in Sections 7.5.1 through 7.5.6, (a) each Party will provide to the Party enforcing or Defending any such rights under Sections 7.5.2, 7.5.3, or 7.5.4, as applicable, reasonable assistance and cooperation in such enforcement, at such enforcing or Defending Party’s reasonable request and expense (subject to Section 7.5.9), (b) the enforcing or Defending Party will keep the other Party regularly informed of the status and progress of such enforcement efforts, and (c) each Party bringing or Defending any such action or proceeding in accordance with this Section 7.5 shall have an obligation to consult with the other Party and will take comments of such other Party into good faith consideration with respect to the infringement, claim construction, or Defense of the validity or enforceability of any claim in any Patent that is the subject of such proceeding, provided that the obligations in Sections 7.5.7(a) through (c) shall not apply to any such action or proceeding relating to Patents Covering the [***].

7.5.8. Enforcement of Third Party Patents . Notwithstanding Sections 7.5.1 and 7.5.2, Celgene acknowledges that the Juno Upstream Agreements may govern enforcement of the Juno Upstream Agreement Patents. Accordingly, Celgene agrees that the applicable provisions of the Juno Upstream Agreements, and any obligations of Juno to any Third Party licensees with respect to the Juno Upstream Agreement Patents, shall be given effect before the provisions of this Section 7.5 apply as to actions involving the Juno Upstream Agreement Patents. Notwithstanding Sections 7.5.1 and 7.5.2, Juno acknowledges that the Celgene Upstream Agreements may govern enforcement of the Celgene Upstream Agreement Patents. Accordingly, Juno agrees that the applicable provisions of the Celgene Upstream Agreements,

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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and any obligations of Celgene to any Third Party licensees with respect to the Celgene Upstream Agreement Patents, shall be given effect before the provisions of this Section 7.5 apply as to actions involving the Celgene Upstream Agreement Patents.

7.5.9. Costs and Recoveries . Each Party shall bear all of its own internal costs incurred in connection with its activities under this Section 7.5. If a Party commences or Defends an action under this Section 7.5, it shall [***]such action or proceeding. Any Damages or other monetary awards recovered in any enforcement action or proceeding brought under this Section 7.5 shall be shared as follows:

(a) the amount of such recovery actually received by the Party controlling such action shall first be applied to costs and expenses incurred by each Party in connection with such action (including, for this purpose, a reasonable allocation of expenses of internal counsel); and

(b) any remaining proceeds shall be allocated between the Parties, such that the Party bringing suit under this Section 7.5 retains [***] and the other Party retains [***] of such amount.

(c) For clarity, the external costs and expenses of Defending any inter partes review proceeding, reexamination or post-grant proceeding shall be borne solely by the Party owning such Patent; provided that the Parties shall share equally all such external costs and expenses of Defending any such action involving a jointly owned Patent.

7.5.10. Enforcement after Option Exercise . The Development & Commercialization Agreements provide separately for each Party’s rights to enforce Patents claiming or covering [***] and products containing or made using such [***] that are the subject of such other agreements.

7.6 Patent Term Extensions . On a Program-by-Program basis, in the course of conducting activities pursuant to this Agreement or the relevant Development & Commercialization Agreement, if either Party wishes to apply for or obtain any patent term extensions, restorations, or supplementary protection certificates (in each case based on delays or activities associates with seeking regulatory approval) under applicable Laws for any Patent within the [***], in each case that Covers or claims [***], or Products containing or made using [***], then Juno and Celgene shall discuss and seek to reach mutual agreement regarding any such action with respect to any such Patents [***] of such [***] Products; it being understood and agreed that, (a) if Celgene seeks a patent term extension, then Juno agrees to [***] for Celgene to obtain such extension and (b) if Juno seeks a patent term extension, then Celgene [***] for Juno to obtain such extension. If the Parties are unable to reach mutual agreement, (i) prior to exercise of the Option for such Program, [***] such Patent shall have the right to make the final decision with respect to such Patent; and (ii) after exercise of the Option for such Program, except as otherwise provided in the applicable Development & Commercialization Agreement(s), the [***] shall have the right to make the final decision.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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7.7 [***] . Notwithstanding anything to the contrary in Sections 7.3 through 7.6, in no event may Celgene assume the Prosecution and Maintenance, enforcement or Defense of any Patent that [***] and in no event may Juno assume the Prosecution and Maintenance, enforcement or Defense of any Patent that [***].

7.8 Limitation as to [***] Patents . Notwithstanding anything to the contrary in this Agreement or any Development & Commercialization Agreement, in no event may Juno Prosecute, Maintain, enforce or Defend any [***] Patent. Notwithstanding anything to the contrary in this Agreement or any Development & Commercialization Agreement, in no event may Celgene Prosecute, Maintain, enforce or Defend any [***] Patent.

7.9 Third Party Licenses.

7.9.1. Notice . On a Program-by-Program basis, if, at any time during the Term, either Party reasonably determines that [***] for the Development, Manufacture or Commercialization of any Development Candidate, [***] Product that is the subject of research, Development, Manufacture and/or Commercialization efforts under this Agreement (and that is the subject of a Juno Option, Celgene Option, a BD Option or an Option exercisable under Section 3.1.5), then such Party will [***].

7.9.2. Pre-Option . Prior to the exercise of the Option, on a Program-by-Program basis, the Development Lead Party with respect to each such Program shall have the right, but not the obligation, at its sole discretion, to determine whether such Party wishes to obtain one or more licenses from one or more Third Parties for such activities or take other appropriate measures in view of such Third Party rights, such as whether [***]. In each case, such Party shall have the right, [***] with respect to such Third Party rights [***].

7.9.3. Post-Option . On a Program-by-Program basis, following the exercise of the Option for such Program, after receiving the notification provided in Section 7.9.1, the Patent Committee, in consultation with the Patent Liaisons will discuss whether the Parties should [***], such as whether [***]. If [***] reasonably determines that any Third Party intellectual property rights may be

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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[***] the Development, Manufacture, or Commercialization of a Development Candidate, [***] Product that is the subject of research, Development, Manufacture and/or Commercialization efforts under this Agreement or such Development & Commercialization Agreement with respect to such Program, [***] shall have the right, but not the obligation, to obtain a license to such Third Party intellectual property (a “ Third Party License ”), with the right to sublicense, in order to permit each Party to conduct its obligations and exercise its rights under such Development & Commercialization Agreement. Notwithstanding the foregoing, [***] shall consider in good faith the other Party’s comments with respect to obtaining such a Third Party License. The terms and conditions involved in obtaining such rights [***]; provided, however, that if the other Party would [***] to perform its obligations and exercise its rights under this Agreement or any Development & Commercialization Agreement, [***] shall structure such Third Party License to allow [***] to grant to the other Party a sublicense thereunder./

7.9.4. Costs . The costs associated with the exercise of rights under any Third Party License obtained under this Section 7.9 shall be borne as follows:

(a) Unless otherwise agreed by the Parties in writing, [***] shall bear the costs associated with negotiating and obtaining such Third Party License, provided that if such Third Party License is obtained pursuant to a Co-Development and Co-Commercialization Agreement, such costs shall be [***]; and

(b) If the Offering Party elects to obtain a Third Party License pursuant to Section 7.9.3, then following the execution of such Third Party License all fees, expenses and royalties associated with the exercise of rights under such Third Party License shall be borne (A) under a License Agreement, [***] under such License Agreement, and (B) under a Co-Development and Co-Commercialization Agreement, [***] such Co-Development and Co-Commercialization Agreement.

ARTICLE 8

CONFIDENTIALITY

8.1 Nondisclosure . Each Party agrees that a Party (the “ Receiving Party ”) receiving Confidential Information of any other Party (the “ Disclosing Party ”) shall (a) maintain in confidence such Confidential Information using not less than the efforts such Receiving Party uses to maintain in confidence its own proprietary information of similar kind and value, but in no event less than a reasonable degree of efforts, (b) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except for disclosures expressly permitted below, and (c) not use such Confidential Information for any purpose except those permitted by this Agreement (it being understood that this clause (c) shall not create or imply any rights or licenses not expressly granted under this Agreement). The obligations of confidentiality, non-disclosure and non-use under this Section 8.1 shall be in full

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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force during the Term and for a period of [***] thereafter. Each Party, upon the request of the other Party, will return all copies of or destroy (and certify such destruction in writing) the Confidential Information disclosed or transferred to it by the other Party pursuant to this Agreement, within [***] of such request or, if earlier, the termination or expiration of this Agreement; provided however that a Party may retain (i) Confidential Information of the other Party which expressly survives such termination pursuant to this Agreement, and (ii) one (1) copy of all other Confidential Information in archives solely for the purpose of establishing the contents thereof.

8.2 Exceptions.

8.2.1. Exceptions . The obligations in Section 8.1 shall not apply with respect to any portion of the Confidential Information of the Disclosing Party that the Receiving Party can show by competent written proof:

(a) was known to the Receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its use, prior to disclosure by the Disclosing Party;

(b) is subsequently disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and without any obligation to keep it confidential or any restriction on its use;

(c) is published by a Third Party or otherwise becomes publicly available or enters the public domain, either before or after it is disclosed to the Receiving Party, without any breach by the Receiving Party of its obligations hereunder; or

(d) is independently developed by or for the Receiving Party or its Affiliates without reference to or reliance upon the Disclosing Party’s Confidential Information.

8.2.2. Residuals . Notwithstanding anything to the contrary in this Agreement or any Development & Commercialization Agreement, a Receiving Party may use any learning, skills, ideas, concepts, techniques, know-how and information, including general chemistry methodologies and general SAR (structure-activity relationship) concepts, retained in intangible form in the unaided memory of the Receiving Party’s directors, employees, contractors, advisors, agents and other personnel of the Receiving Party who had access to the Disclosing Party’s Confidential Information (collectively, “ Residual Information ”) for any purpose, provided that this right to use Residual Information does not represent a license to any Patents Controlled by the Disclosing Party. For purposes of clarity, nothing contained in the preceding sentence gives the Receiving Party the right to publish or otherwise disclose or use the tangible source of any Residual Information for any purpose other than as provided for in this Agreement or any Development & Commercialization Agreement, as applicable.

8.3 Authorized Disclosure.

8.3.1. Disclosure . Notwithstanding Section 8.1, the Receiving Party may disclose Confidential Information belonging to the Disclosing Party, and Confidential Information deemed to belong to both the Disclosing Party and the Receiving Party, to the extent (and only to the extent) such disclosure is reasonably necessary in the following instances:

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(a) subject to Section 8.5, complying with applicable Laws (including the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) or any national securities exchange) and with judicial process, if in the reasonable opinion of the Receiving Party’s counsel, such disclosure is necessary for such compliance;

(b) disclosure of the other Party’s Confidential Information to any of its officers, employees, consultants, agents or Affiliates or sublicensees [***]; provided that each such person is bound by written confidentiality obligations to maintain the confidentiality thereof and not to use such Confidential Information except as expressly permitted by this Agreement;

(c) disclosure, solely on a “need to know basis,” to (i) Affiliates, potential or actual research and development collaborators, subcontractors, advisors (including attorneys and accountants), (ii) subject to Section 8.3.1(d), actual or potential acquirers, investment bankers, investors, lenders, or other potential financial partners, and (iii) in each case of (i) and (ii), their and each of the Parties’ respective directors, employees, contractors and agents; provided, that in all cases of (i), (ii) and (iii), prior to any such disclosure, each disclosee must be bound by written obligations of confidentiality, non-disclosure and non-use no less restrictive than the obligations set forth in this Article 8 (provided, however, that in the case of prospective investment bankers, investors, lenders or other financial partners, the term of confidentiality may be [***] from the date of disclosure and in the case of legal advisors, no written agreement shall be required), which for the avoidance of doubt, will not permit use of such Confidential Information for any purpose except those permitted by this Agreement; provided, however, that, in each of the above situations, the Receiving Party shall remain responsible for any failure by any Person who receives Confidential Information pursuant to this Section 8.3.1(c) to treat such Confidential Information as required under this Article 8; and

(d) in the case of any disclosure of this Agreement, or any executed Development & Commercialization Agreement, to any actual or potential acquirer, or prospective investment bankers, investors, lenders or other financial partners, such disclosure shall solely be [***]; it being understood and agreed that only [***] this Agreement or such Development & Commercialization Agreement, as applicable, to such Third Party.

8.3.2 Terms of Disclosure . If and whenever any Confidential Information is disclosed in accordance with this Section 8.3, such disclosure shall not cause any such information to cease to be Confidential Information except to the extent that such disclosure

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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results in a public disclosure of such information (other than by breach of this Agreement). Where reasonably possible and subject to Section 8.5, the Receiving Party shall notify the Disclosing Party of the Receiving Party’s intent to make any disclosures pursuant to Section 8.3.1(a) sufficiently prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information, and the Receiving Party will provide reasonable assistance to the Disclosing Party with respect thereto; provided that, in the event, the Receiving Party will use reasonable measures to ensure confidential treatment of such information and shall only disclose such Confidential Information of the Disclosing Party as is necessary to comply with such Laws or judicial process.

8.4 Terms of this Agreement . The Parties agree that this Agreement, and all Development & Commercialization Agreements (if and when executed), and all of the respective terms hereof and thereof shall be deemed to be Confidential Information of Juno and Celgene, and each Party agrees not to disclose any of them without the prior written consent of the other Party, except that each Party may disclose any of them in accordance with the procedures of Section 8.3 (and the provisions related thereto, including, to the extent applicable, the provisions of Section 8.5).

8.5 Securities Filings . Each Party acknowledges and agrees that the other Party may submit this Agreement or any executed Development & Commercialization Agreement to the SEC or any national securities exchange in any jurisdiction (collectively the “ Securities Regulators ”), and if a Party does submit this Agreement or any such Development & Commercialization Agreement to any Securities Regulators, such Party agrees to consult with the other Party with respect to the preparation and submission of, a confidential treatment request for such agreement. Notwithstanding the foregoing, if a Party is required by applicable Law or any Securities Regulator to make a disclosure of the terms of this Agreement or any Development & Commercialization Agreement in a filing with or other submission to such Securities Regulator, and (a) such Party has provided copies of the disclosure to the other Party as far in advance of such filing or other disclosure as is reasonably practicable under the circumstances, (b) such Party has promptly notified the other Party in writing of such requirement and any respective timing constraints, and (c) such Party has given the other Party a reasonable time under the circumstances from the date of notice by such Party of the required disclosure to comment upon, request confidential treatment or approve such disclosure, then such Party will have the right to make such public disclosure at the time and in the manner reasonably determined by its counsel to be required by applicable Law. Notwithstanding anything to the contrary herein, it is hereby understood and agreed that if a Party seeking to make a disclosure to a Securities Regulator as set forth in this Section 8.5, and the other Party provides comments within the respective time periods or constraints specified herein or within the respective notice, the Party seeking to make such disclosure or its counsel, as the case may be, will in good faith consider incorporating such comments.

8.6 Publicity.

8.6.1. Press Release .The Parties agree to issue a mutually agreed upon press release promptly after execution of this Agreement. Promptly following the exercise of the Option for a Program, the Parties shall discuss and mutually agree upon a form of press release

 

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that may be issued by each Party following the execution of a Development & Commercialization Agreement for such Program. Notwithstanding the foregoing, any disclosure that is required by applicable Laws (including the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended) or the rules of any Securities Regulator or the securities regulations of any state or other jurisdiction, or by judicial process shall be in accordance with Sections 8.3 and 8.5, as applicable. Without limiting the foregoing, each Party agrees to provide to the other Party a copy of any public announcement covered by this Section 8.6 as soon as reasonably practicable under the circumstances prior to its scheduled release. Except under extraordinary circumstances, each Party shall provide the other Party with an advance draft of any such announcement at least [***] prior to its scheduled release. Each Party shall have the right to expeditiously review and recommend changes to any such announcement and, except as otherwise required by applicable Laws or such rules or regulations, the Party whose announcement has been reviewed [***] within the applicable review period (not to exceed [***]).

8.6.2. Restrictions on Disclosure . Notwithstanding anything to the contrary in this Agreement, other than the permitted disclosures addressed in Section 8.5:

(a) on a Program-by-Program basis, for any press release or other public statement proposed to be made, if such press release or public statement discloses any information with respect to the research, development, manufacture or commercialization of any [***], or products constituting, incorporating, comprising, made using or containing [***], including any information related to [***] under this Agreement or any Development & Commercialization Agreement, [***] with respect thereto, such press release or other public statement may not be issued without [***] prior written consent (in the case of information relating to any [***] Program or any Program under a License Agreement or Juno Lead Co-Co Agreement), or [***] prior written consent (in the case of information relating to any [***] Program or any Program under a Celgene Lead Co-Co Agreement), except, for such disclosures by [***], and without limiting Section 8.3.1(a), solely and to the extent [***] determines such disclosure is required to be disclosed by applicable Law; provided that in such case [***] shall use reasonable efforts to allow [***] to have a reasonable period of time to review any such disclosure and any reasonable comments made by[***] will be incorporated in good faith; provided that [***] prior to the exercise of the Option shall have final decision-making authority with respect to the content of such disclosure;

(b) in the event a Party proposes that the other Party use specific wording or language regarding any compound or product that the proposing Party or any of its Affiliates develops or commercializes as of the Effective Date or during the Term outside the scope of the Collaboration, with respect to any press release or other public statement, the other Party shall use reasonable efforts to incorporate such wording or language; and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(c) the contents of any press release or other public statement that has been reviewed and approved by a reviewing Party may be re-released by such reviewing Party or publishing Party without a requirement for re-approval.

8.7 Permitted Publications.

8.7.1. By Either Party Post Option Exercise . Subject to Sections 8.7.2 and 8.7.3, on a Program-by-Program basis, in the event either Party (the “ Publishing Party ”) desires to publish or present any information with respect to any [***], the Publishing Party shall provide the other Party with a copy of such proposed publication or presentation no less than [***] prior to its intended submission for publication or public disclosure. The other Party shall respond in writing promptly and in no event later than [***] after receipt of the proposed material, with one or more of the following: (a) comments on the proposed material, which the Publishing Party shall consider in good faith; (b) a [***], or any research or Development activities conducted under this Agreement, in which event the Publishing Party agrees not to submit such publication or make such presentation that contains such information until the other Party is given a reasonable period of time, and in no event less than [***] to seek patent protection for any material in such publication or presentation which it believes is patentable or to resolve any other issues or to abandon such proposed publication or presentation if such other Party reasonably determines in good faith that maintaining such information as a trade secret is a commercially-reasonable priority; or (c) an identification of the other Party’s Confidential Information that is contained in the material reviewed, which the Publishing Party shall remove, if requested by the other Party.

8.7.2. Specified Language . In the event a Party proposes that the other Party use specific wording or language regarding any compound or product that the proposing Party or any of its Affiliates develops or commercializes as of the Effective Date or during the Term outside of the Collaboration, with respect to any publication or presentation, the other Party shall use reasonable efforts to incorporate such wording or language.

8.7.3. Re-Publication; Re-Presentation . The contents of any publication or presentation that has been reviewed and approved by a reviewing Party may be re-released by such reviewing Party or Publishing Party without a requirement for re-approval.

8.8 Relationship to Existing Confidentiality Agreement . This Agreement supersedes that certain Mutual Confidentiality Agreement entered into between Juno and Celgene, dated [***] (the “ Existing Confidentiality Agreement ”); provided that all “Confidential Information” disclosed by the “Disclosing Party” thereunder shall be deemed

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Confidential Information of the Disclosing Party hereunder and shall be subject to the terms and conditions of this Agreement and the “Receiving Party” thereunder shall be bound by and obligated to comply with such terms and conditions as if they were the Receiving Party hereunder. The foregoing shall not be interpreted as a waiver of any remedies available to the “Disclosing Party” as a result of any breach, prior to the Effective Date, by the “Receiving Party,” respectively, of its obligations pursuant to the Existing Confidentiality Agreement.

8.9 Relationship with Other Agreements . The confidentiality, non-disclosure and non-use obligations of this Article 8 shall apply equally to the Parties’ activities under (a) this Agreement, and (b) on a Program-by-Program basis, each Development & Commercialization Agreement entered into by the Parties following a Party’s exercise of an Option for such Program.

8.10 Reversion of Rights upon Expiration of the Option Term . On a Program-by-Program basis, in the event a reversion of rights occurs pursuant to Sections 2.9.1 or 2.9.2, as a result of expiration of the Option Term, with respect to such Program, any Confidential Information solely related to such Program, or relating to [***], shall be deemed the Confidential Information of [***]; provided, that with respect to any data or information (a) generated or disclosed solely by the other Party hereunder in relation to such Program, or (b) generated by or on behalf of [***] that references or uses any Confidential Information of the other Party shall, in each case, be deemed the Confidential Information of such other Party.

8.11 Clinical Trials Registry . Notwithstanding anything to the contrary in this Article 8, either Party shall have the right to publish registry information and summaries of data and results from any human Clinical Trials conducted by either Party in connection with activities under this Agreement or any Development & Commercialization Agreement, if applicable, on its clinical trials registry or on a government-sponsored database such as www.clinicaltrials.gov or other publicly available websites such as www.clinicalstudyresults.org, without requiring the consent of the other Party. The Parties shall reasonably cooperate if required or reasonably requested by the Party seeking such publication in order to facilitate any such publication by either Party.

ARTICLE 9

REPRESENTATIONS AND WARRANTIES

9.1 Representations and Warranties of Both Parties . Each Party hereby represents and warrants to the other Party, as of the Original Execution Date, or the effective date of the applicable Development & Commercialization Agreement, as applicable, that:

(a) such Party is duly organized, validly existing and in good standing under the Laws of the jurisdiction of its formation and has full corporate power and authority to enter into this Agreement or any applicable Development & Commercialization Agreement, and to carry out the provisions hereof or thereof, as applicable;

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(b) such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement or any applicable Development & Commercialization Agreement, and the performance of its obligations hereunder or thereunder, as applicable;

(c) this Agreement or any applicable Development & Commercialization Agreement, has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof or thereof, as applicable;

(d) the execution, delivery and performance of this Agreement or any applicable Development & Commercialization Agreement, by such Party does not conflict with any agreement or any provision thereof, or any contract, oral or written, to which it is a party or by which it is bound, nor violate any Law of any Governmental Authority having jurisdiction over such Party; and

(e) except for any HSR/Antitrust Filings that may be required under the HSR Act as addressed in Section 3.2.2, no authorization, consent, approval, license, exemption of, or filing or registration with, in each case any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable Laws currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials.

9.2 Representations and Warranties of Juno . Juno hereby represents and warrants to Celgene, as of the Original Execution Date, that:

(a) Juno has all rights, authorizations and consents (other than government consents, which are covered in Section 3.2) necessary to grant all rights and licenses it purports to grant to Celgene with respect to the Juno IP under this Agreement;

(b) neither Juno nor any of its Affiliates has granted any right or license to any Third Party relating to any of the Juno IP that would conflict with or limit the scope of any of the rights or licenses granted to Celgene hereunder;

(c) neither Juno nor any of its Affiliates has granted any liens or security interests on the Juno IP and the Juno IP is free and clear of any mortgage, pledge, claim, security interest, covenant, easement, encumbrance, lien or charge of any kind, except in each case with respect to licenses, covenants not to sue, immunities from suit, standstills, releases and options which would not, in the aggregate, fundamentally frustrate the purposes of the Collaboration;

(d) except as disclosed in writing to Celgene prior to the Original Execution Date, neither Juno nor its Affiliates has received any written notice of any claim that any Patent or trade secret right owned or controlled by a Third Party would be infringed or misappropriated by the research, Development, Manufacture, or Commercialization of any [***], by either Party or its Affiliates or sublicensees as [***] this Agreement (including pursuant to a Development & Commercialization Agreement);

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(e) there are no claims litigations, suits, actions, disputes, arbitrations, or legal, administrative or other proceedings or governmental investigations pending or, to Juno’s knowledge, threatened against Juno, nor is Juno a party to any judgment or settlement, which would be reasonably expected to adversely affect or restrict the ability of Juno to consummate the transactions contemplated under this Agreement (including pursuant to a Development & Commercialization Agreement) and to perform its obligations under this Agreement, or which would affect the Juno IP, or Juno’s Control thereof, or any Target or Development Candidate; and

(f) solely with respect to the [***].

9.3 Representations and Warranties of Celgene . Celgene hereby represents and warrants to Juno, as of the Original Execution Date, that:

(a) Celgene has all rights, authorizations and consents (other than government consents, which are covered in Section 3.2) necessary to grant all rights and licenses it purports to grant to Juno with respect to the Celgene IP under this Agreement;

(b) neither Celgene nor any of its Affiliates has granted any right or license to any Third Party relating to any of the Celgene IP that would conflict with or limit the scope of any of the rights or licenses granted to Juno hereunder;

(c) neither Celgene nor any of its Affiliates has granted any liens or security interests on the Celgene IP and the Celgene IP is free and clear of any mortgage, pledge, claim, security interest, covenant, easement, encumbrance, lien or charge of any kind, except in each case with respect to licenses, covenants not to sue, immunities from suit, standstills, releases and options which would not, in the aggregate, fundamentally frustrate the purposes of the Collaboration;

(d) neither Celgene nor its Affiliates has received any written notice of any claim that any Patent or trade secret right owned or controlled by a Third Party would be infringed or misappropriated by the research, Development, Manufacture, or Commercialization of [***], by either Party or its Affiliates or sublicensees [***] this Agreement (including [***]); and

(e) there are no claims litigations, suits, actions, disputes, arbitrations, or legal, administrative or other proceedings or governmental investigations pending or, to

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Celgene’s knowledge, threatened against Celgene, nor is Celgene a party to any judgment or settlement, which would be reasonably expected to adversely affect or restrict the ability of Celgene to consummate the transactions contemplated under this Agreement (including pursuant to any Development & Commercialization Agreement) and to perform its obligations under this Agreement, or which would affect the Celgene IP, or Celgene’s Control thereof, or any Target or Development Candidate.

9.4 Covenants .

9.4.1. Mutual Covenants . Each Party hereby covenants to the other Party that:

(a) all employees of such Party or its Affiliates or Third Party subcontractors working under this Agreement, or any Development & Commercialization Agreement, as applicable, will be under appropriate confidentiality provisions at least as protective as those contained in this Agreement, or any Development & Commercialization Agreement, as applicable, and,, to the extent permitted under applicable Law, the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, to such Party as the sole owner thereof;

(b) to its knowledge, such Party will not (i) employ or use, nor hire or use any contractor or consultant that employs or uses, any individual or entity, including a clinical investigator, institution or institutional review board, debarred or disqualified by the FDA (or subject to a similar sanction by any Regulatory Authority outside the United States) or (ii) employ any individual who or entity that is the subject of an FDA debarment investigation or proceeding (or similar proceeding by any Regulatory Authority outside the United States), in each of subclauses (i) and (ii) in the conduct of its activities under this Agreement and any Development & Commercialization Agreement, as applicable;

(c) neither Party nor any of its Affiliates shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it owns or Controls which would conflict with any of the rights or licenses granted to the other Party hereunder or under any Development & Commercialization Agreement; and

(d) such Party and its Affiliates shall perform its activities pursuant to this Agreement and any Development & Commercialization Agreement, as applicable, in compliance (and shall ensure compliance by any of its subcontractors) in all material respects with all applicable Laws, including GCP, GLP and GMP as applicable and with respect to the research, Development, Manufacturing and Commercialization activities hereunder.

(e)

(i) The Parties shall, within [***] after the Effective Date, [***]; and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(ii) The Parties shall, within [***] after the Effective Date, [***].

(iii) The Parties agree and acknowledge that (A)  Exhibits B-1 , B-2 and B-3 , and Exhibit C-1,C-2 and C-3 , shall supersede Exhibits B and C (as applicable) for all purposes of this Agreement, and (B) as applicable, references to the Juno Lead Co-Co Agreement and the Celgene Lead Co-Co Agreement in the other provisions of this Agreement shall be [***], in the case of the Juno Lead Co-Co Agreement, and to the [***], in the case of the Celgene Lead Co-Co Agreement. The Parties further agree that each entry into a [***] (each, a “ Co-Co Agreement ”) shall be [***]. For the avoidance of doubt, the revision contemplated in this Section 9.4.1(e) shall include any necessary or incidental changes to Exhibits thereof. Neither Party shall [***], unless otherwise required by applicable Law.

(iv) The Parties agree and acknowledge that, notwithstanding any other provision in this Agreement or the Co-Co Agreements, (A) any [***], and (B) [***]; and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(v) The Parties agree and acknowledge that (A) the terms of this Agreement with respect to the Research Collaboration Term and (B) the terms of the form of License Agreement attached hereto as Exhibit A [***]. Neither Party shall [***], unless otherwise required by applicable Law.

(f) The Parties agree to cooperate in good faith to (i) take such actions and execute such documents to [***] and (ii) incorporate the following additional concepts into the Exhibits to this Agreement as soon as reasonably practicable following the Original Execution Date: [***].

9.4.2. Upstream Agreement Covenants . Juno hereby covenants to Celgene that Juno shall maintain the Juno Upstream Agreements, and shall not amend or terminate such agreements, and will not breach such agreements, if such amendment, modification, termination or breach would [***], as applicable. Celgene hereby covenants to Juno that Celgene shall maintain the Celgene Upstream Agreements, and shall not amend or terminate such agreements, and will not breach such agreements, if such amendment, modification, termination or breach would [***], as applicable.

9.5 Disclaimer . Except as otherwise expressly set forth in this Agreement or any executed Development & Commercialization Agreement or the Equity Purchase Agreement, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY THAT ANY PATENTS ARE VALID OR ENFORCEABLE, AND EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. Without limiting the generality of the foregoing, each Party disclaims any warranties with regards to: (a) the success of any study or test, including any Program, commenced under this Agreement; (b) the safety or usefulness for any purpose of the technology or materials, including any Development Candidate, Product or Diagnostic Product, it provides or discovers under this Agreement; or (c) the validity, enforceability, or non-infringement of any intellectual property rights or technology it provides or licenses to the other Party under this Agreement.

 

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ARTICLE 10

INDEMNIFICATION; INSURANCE

10.1 Indemnification by Celgene . Celgene shall indemnify, defend and hold harmless Juno and its directors, officers, employees and agents (collectively, the “ Juno Indemnitees ”), from and against any and all Damages to the extent arising out of or relating to, directly or indirectly, from any Claim based upon:

10.1.1. the [***], in connection with [***] under this Agreement;

10.1.2. any [***] under this Agreement; or

10.1.3. the [***], including any [***] resulting from any of the foregoing [***];

in each case, provided however that, such indemnity shall not apply to the extent Juno has an indemnification obligation pursuant to Section 10.2 for such Damages.

10.2 Indemnification by Juno . Juno shall indemnify, defend and hold harmless Celgene and its directors, officers, employees and agents (collectively, the “ Celgene Indemnitees ”), from and against any and all Damages to the extent arising out of or relating to, directly or indirectly, from any Claim based upon:

10.2.1. the [***] in connection with [***] under this Agreement;

10.2.2. any [***] under this Agreement; or

10.2.3. the [***], including any [***]resulting from any of the foregoing [***];

 

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in each case, provided however that, such indemnity shall not apply to the extent Celgene has an indemnification obligation pursuant to Section 10.1 for such Damages.

10.3 Notice of Claims . A Claim to which indemnification applies under Section 10.1 or Section 10.2 shall be referred to herein as an “ Indemnification Claim .” If the Indemnitee intends to claim indemnification under this Article 10, the Party claiming indemnification (the “ Indemnitee ”) shall notify the indemnifying Party (the “ Indemnitor ”) in writing, promptly upon becoming aware of an Indemnification Claim, describing in reasonable detail the facts giving rise to the Indemnification Claim; provided, that an Indemnification Claim in respect of any action at law or suit in equity by or against a Third Party as to which indemnification shall be sought shall be given promptly after the action or suit is commenced (provided that the Indemnitee is aware of such commencement); and provided further, that the failure by an Indemnitee to give such notice shall not relieve the Indemnitor of its indemnification obligation under this Agreement except and only to the extent that the Indemnitor is actually prejudiced as a result of such failure to give notice.

10.4 Indemnification Procedures . If an Indemnitee receives written notice of a Claim that the Indemnitee believes may result in a claim for indemnification under this Article 10, such Indemnitee shall deliver an Indemnification Claim to the Indemnitor in accordance with the provisions of Section 10.3. If [***], then the Indemnitor shall have the right to assume and control the defense of the Claim, at its own expense with counsel selected by it and reasonably acceptable to the Indemnitee, by delivering written notice of its assumption of such defense to the Indemnitee within [***] of its receipt of notice of such Claim from the Indemnitor (but the Indemnitor shall in any event have the right to assume and control the defense of a Claim that [***], whichever is first); provided, however, that the Indemnitee shall have the right to retain its own counsel, with the reasonable fees and expenses to be paid by the Indemnitor, if (a) representation of the Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential conflict of interests between such Indemnitee and Indemnitor, (b) the Indemnitor has failed within a reasonable time to retain counsel, (c) the Indemnitee shall have reasonably concluded that there may be legal defenses available to it that are different from or in addition to those available to the Indemnitor, or (d) [***]. If the Indemnitor assumes and controls the defense of such Claim, the Indemnitor shall keep the Indemnitee reasonably apprised of the status of the Claim and the Indemnitee shall be entitled to otherwise monitor such Claim at its sole cost and expense. If the Claim [***] against or from the Indemnitee or if the Indemnitor does not assume the defense of the Claim as described in this Section 10.4, the Indemnitee shall be permitted to assume and control the defense of such Claim (but shall have no obligation to do so) and in such event shall be entitled to settle or compromise the Indemnification Claims in its sole and reasonable discretion, provided that if the Indemnitee is entitled to assume the defense of the Claim pursuant to this Section 10.4 solely because the Claim [***] against or from the Indemnitee, then the Indemnitee shall not settle or compromise such Indemnification Claims in any manner that [***]

 

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[***] without the prior written consent of the Indemnitor, which consent the Indemnitor shall not unreasonably withhold, condition or delay. If the Indemnitor has assumed and controls the defense of the Claim in accordance with this Section 10.4, (i) the Indemnitee shall not settle or compromise the Indemnification Claim without the prior written consent of the Indemnitor, such consent not to be unreasonably withheld, conditioned or delayed and (ii) the Indemnitor shall not settle or compromise the Indemnification Claim in any manner that would result in the payment of amounts by the Indemnitee, impose any other obligation on the Indemnitee or otherwise have an adverse effect on the Indemnitee’s rights or interests (including any rights under this Agreement or the Equity Purchase Agreement or the scope or enforceability of any Patents or Know-How licensed by one Party to another Party pursuant to this Agreement or a Development & Commercialization Agreement), without the prior written consent of the Indemnitee. In each case, the Party that is not controlling the defense of any Claim shall reasonably cooperate with the Party that is controlling the defense of such Claim, at the non-controlling Party’s expense and shall make available to the controlling Party all pertinent information under the control of the non-controlling Party, which information shall be subject to Article 8 (Confidentiality). Each Party shall use commercially reasonable efforts to avoid production of Confidential Information of the other Party (consistent with applicable Law and rules of procedure), and to cause all communications among employees, counsel and other representatives of such Party to be made so as to preserve any applicable attorney-client or work-product privileges.

10.5 Indemnification Following Exercise of the Option . The Development & Commercialization Agreements provide separately for each Party’s indemnification obligations with respect to each Development Candidate, Product or Diagnostic Product, that is the subject of such agreement following exercise of the Option for such Program.

10.6 LIMITATION OF LIABILITY . EXCEPT (A) FOR A BREACH OF SECTIONS [***]. AS APPLICABLE, OR [***] OR (B) FOR CLAIMS THAT ARE SUBJECT TO INDEMNIFICATION UNDER THIS Article 10 OR (C) FOR DAMAGES DUE TO THE [***] OF THE LIABLE PARTY, NEITHER JUNO NOR CELGENE, NOR ANY OF THEIR RESPECTIVE AFFILIATES WILL BE LIABLE TO THE OTHER PARTY TO THIS AGREEMENT OR ITS AFFILIATES FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE OR EXEMPLARY DAMAGES OR LOST PROFITS OR LOST DATA, WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY), INDEMNITY OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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ARTICLE 11

TERM AND TERMINATION

11.1 Term; Expiration . Unless earlier terminated in accordance with this Article 11, the term of this Agreement (the “ Term ”) shall commence as of the Effective Date and remain in force until the later of (a) the expiration of the last-to-expire of all Option Terms and (b) if one or more Options is exercised, the termination or expiration of the last to expire Development & Commercialization Agreement executed with respect to any Program hereunder.

11.2 Termination for Breach .

11.2.1. Material Breach . Subject to the other terms of this Agreement, this Agreement and the rights granted herein may be terminated by either Party (a) on a Program-by-Program basis prior to the exercise of an Option or BD Option for such Program, as applicable, for the material breach by the other Party of this Agreement with respect to such Program that frustrates the fundamental purpose of this Agreement, or (b) on a Program-by-Program basis after a Party’s exercise of an Option or BD Option for such Program, if a Development & Commercialization Agreement for such Program is terminated for material breach by a Party that frustrates the fundamental purpose of this Agreement; provided in each of (a) or (b), that the breaching Party has not cured such breach within [***] after the date of written notice to the breaching Party of such breach (or [***] in the case of a breach as a result of non-payment of any amounts due under this Agreement or a Development & Commercialization Agreement, as applicable) (the “ Cure Period ”), which notice shall describe such breach in reasonable detail and shall state the non-breaching Party’s intention to terminate this Agreement with respect to a given Program, pursuant to this Section 11.2.1 with respect to such Program. For clarity, the Cure Period for any allegation made in good faith as to a material breach under this Agreement with respect to a given Program for events described in this Section 11.2.1 will run from the date that written notice was first provided to the breaching Party by the non-breaching Party. Any such termination of this Agreement with respect to a given Program under this Section 11.2.1 shall become effective at the end of the Cure Period, unless the breaching Party has cured any such breach or default prior to the expiration of such Cure Period, or, if such breach is not susceptible to cure within the Cure Period, then, the non-breaching Party’s right of termination shall be [***]. For the avoidance of doubt, termination of any particular Program(s) pursuant to this Section 11.2.1 shall not terminate (i) this Agreement with respect to any other Program(s), or (ii) any Development & Commercialization Agreement for any other Program. The Parties understand and agree that the totality of this Agreement with respect to a given Program, and the [***].

11.2.2. Disagreement as to Material Breach . If the Parties reasonably and in good faith disagree as to whether there has been a material breach pursuant to Section 11.2.1, subject

 

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to Section 12.7, the Party that disputes that there has been a material breach may contest the allegation by referring such matter, within [***] for resolution to the Executive Officers, who shall meet promptly to discuss the matter, and determine, within [***] following referral of such matter, whether or not a material breach has occurred pursuant to Section 11.2.1, as applicable. If the Executive Officers are unable to resolve a dispute within such [***] period after it is referred to them, the matter will be resolved as provided in Section 12.7. It is understood and agreed that (a) during the pendency of any such dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder), and (b) if it is finally and conclusively determined that the breaching Party committed such material breach, then the breaching Party shall have the right to cure such material breach after such determination within the Cure Period provided above, less [***].

11.3 Voluntary Termination .

11.3.1. Termination by Celgene . Celgene may terminate this Agreement in its entirety (but, for clarity, not on Program by Program basis) at will, subject to Section 11.3.2, at any time during the Term upon [***] prior written notice to the other Party hereunder.

11.3.2. Restrictions . For clarity, neither Party may terminate this Agreement pursuant to this Section 11.3 with respect to any Program for which such Party has exercised its Option during the term of any applicable Development & Commercialization Agreement for such Program, unless it also terminates such Development & Commercialization Agreement.

11.4 Termination for Bankruptcy . If either Party makes a general assignment for the benefit of creditors, appoints or suffers appointment of a receiver or trustee over all or substantially all of its property, files a petition under any bankruptcy or insolvency act or has any such petition filed against it which is not dismissed, discharged, bonded or stayed within ninety (90) days after the filing thereof, the other Party may terminate this Agreement in its entirety effective immediately upon written notice to such Party, provided that this Agreement may only be terminated in its entirety pursuant to this Section 11.4 in connection with the termination of all Development & Commercialization Agreements (if any), executed hereunder. In connection therewith, the provisions of Section 7.1.7 shall apply.

11.5 Termination for Patent Challenge . Either Party shall have the right to terminate this Agreement solely on a Program-by-Program basis upon written notice if the other Party or any Affiliate (as defined in Section 1.2(a)) challenges the validity, scope or enforceability of or otherwise opposes any Patent (a) included in the [***] and that is licensed to Celgene under this Agreement, or (b) included in the [***] and that is licensed to Juno under this Agreement (other than in either case as may be necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order) it being understood and agreed that either Party’s right to terminate this Agreement under this Section 11.5 shall not apply to any

 

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actions undertaken by an Affiliate (as defined in Section 1.2(a)) of the other Party (the “ Challenging Party ”) that first becomes such an Affiliate as a result of or after the effective date of a Business Combination involving the Challenging Party, where such new Affiliate was undertaking any of the activities described in the foregoing clause prior to such Business Combination; provided that a Party’s right to terminate this Agreement under this Section 11.5 shall apply to actions undertaken by such new Affiliate if the Challenging Party is the acquiror in such Business Combination and such new Affiliate does not terminate or otherwise cease such challenge or opposition within [***] after the effective date of such Business Combination. If a Sublicensee of a Party challenges the validity, scope or enforceability of or otherwise opposes any Patent (i) included in the [***] (in the case of a Sublicensee of Celgene), or (ii) included in the [***] (in the case of a Sublicensee of Juno), in each case under which such Sublicensee is sublicensed, then such Party shall, [***], terminate such sublicense. For the avoidance of doubt, an action by a Party or any Affiliate (as defined in Section 1.2(a)) (collectively the “ Prosecuting Party ”) in accordance with Article 7 to amend claims within a pending patent application of the other Party during the course of the Prosecuting Party’s Prosecution and Maintenance of such pending patent application or in defense of a Third Party proceeding, or to make a negative determination of patentability of claims of a patent application of the other Party or to abandon a patent application of the other Party during the course of the Prosecuting Party’s Prosecution and Maintenance of such pending patent application, shall not constitute a challenge under this Section 11.5.

11.6 Termination for Failure to Close Share Purchase Agreement or Breach of Standstill . Juno may terminate this Agreement immediately upon written notice to Celgene, in the event that (i) either Juno or Celgene terminates the Equity Purchase Agreement pursuant to Section 6.1 thereof prior to the first acquisition of shares of capital stock of Juno pursuant to Section 2.1 of the Equity Purchase Agreement, other than by reason of a Terminating Company Breach (as defined therein), or (ii) Juno exercises its right to terminate this Agreement under Section 2.2 of the Voting and Standstill Agreement dated as of the Original Execution Date (“ Voting and Standstill Agreement ”), by and between Juno and Celgene resulting in the termination of the Voting and Standstill Agreement.

11.7 Effects of Expiration or Termination .

11.7.1. Termination by Juno Pursuant to Section 11.2, 11.411.5, or 11.6, or by Celgene pursuant to Section 11.3. In the event of termination of this Agreement in part with respect to any one or more Programs, or in its entirety, as applicable, (i) by Celgene pursuant to Section 11.3, or (ii) by Juno pursuant to any of Sections 11.2, 11.4, 11.5 and 11.6, notwithstanding anything contained in this Agreement to the contrary, upon the effective date of such termination:

(a) subject to Section 11.7.1(e) and Sections 11.8, 11.9, and 11.10, all rights (including all Options and BD Options granted to Celgene hereunder) and licenses granted herein to Celgene with respect to any such terminated Programs [***] shall terminate, Celgene shall cease any and all research, Development, Manufacture and Commercialization activities under this Agreement with respect to all terminated Juno Programs and [***] Development Candidates within such terminated Programs, and all rights in such terminated [***] Juno Development Candidates granted by Juno to Celgene shall revert to Juno;

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(b) with respect to termination by Juno pursuant to [***] for each Celgene Program for which Juno is exercising its termination right, [***];

(c) all Development & Commercialization Agreements previously entered into by the Parties for Programs for which either Party exercised its Option or BD Option shall continue in full force, in accordance with the terms and conditions of such Development & Commercialization Agreements;

(d) each Party shall return or destroy all Confidential Information of the other Party with respect to any terminated Programs [***] being researched, Developed, Manufactured or Commercialized under this Agreement, as required by Article 8;

(e) Section 7.1.1(b), 7.1.1(c), 7.1.2(c), 7.1.2(d) and 7.1.2(e) shall survive; and

(f) Section 11.8 shall apply.

11.7.2. Termination by Celgene Pursuant to Section 11.2, 11.4 or 11.5 . In the event of termination of this Agreement with respect to any one or more Programs conducted hereunder or in its entirety by Celgene pursuant to Sections 11.2, 11.4 or 11.5, notwithstanding anything contained in this Agreement to the contrary, upon the effective date of such termination:

(a) subject to Section 11.7.2(c) and Sections 11.8, 11.9, and 11.10, all rights (including all Options and BD Options granted to Juno hereunder) and licenses granted herein to Juno with respect to any such terminated Programs [***] shall terminate, Juno shall cease any and all research, Development, Manufacture and Commercialization activities under this Agreement with respect to all terminated Celgene Programs and all Development Candidates [***] within such terminated Programs, and all rights in such [***] Celgene Development Candidates granted by Celgene to Juno shall revert to Celgene;

(b) with respect to termination by Celgene pursuant to [***], for each Juno Program for which Celgene is exercising its termination right, [***];

 

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(c) Section 7.1.1(b), 7.1.1(c), 7.1.2(c), 7.1.2(d) and 7.1.2(e) shall survive such termination;

(d) all Development & Commercialization Agreements previously entered into by the Parties for Programs for which either Party exercised its Option shall continue in full force, in accordance with the terms and conditions of such Development & Commercialization Agreements, as applicable;

(e) each Party shall return or destroy all Confidential Information of the other Party with respect to any terminated Programs [***] in the terminated Programs being researched, Developed, Manufactured or Commercialized under this Agreement, as required by Article 8; and

(f) Section 11.9 shall apply.

11.8 Juno Reversion Compounds .

11.8.1. Reversion . If this Agreement terminates with respect to one or more Juno Programs and/or Eligible BD Programs for which Juno is the BD Acquiring Party [***], or if rights revert to Juno pursuant to Sections 2.9.1, then [***] such terminated Juno Programs, Eligible BD Programs [***] shall be deemed “ Juno Reversion Compounds ” and Celgene shall grant, shall (within [***] after the Effective Date) cause its Affiliates to grant, and hereby grants to Juno a non-exclusive, worldwide, royalty-free, non-transferable (except as provided in Section 12.4) license, with the right to grant sublicenses, [***], in each case that are [***], to research, develop, manufacture, use, import, offer for sale, sell, and commercialize Juno Reversion Compounds and products containing such Juno Reversion Compounds in the Territory in the Field, in each case solely to the extent that [***], as applicable.

11.8.2. Effects of Reversion . With respect to any [***] that becomes a Juno Reversion Compound:

(a) Celgene shall return to Juno within a reasonable time, at no cost to Juno, all tangible embodiments of Juno Know-How transferred by Juno to Celgene with respect to each such Juno Reversion Compound;

 

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(b) Except to the extent not permitted pursuant to any agreements between Celgene and a Third Party, Celgene shall provide to Juno, within a reasonable time, at Juno’s request, subject to [***] pertaining to the applicable Juno Reversion Compounds [***] of such Juno Reversion Compounds under the terms of this Agreement;

(c) With respect to [***] that becomes a Juno Reversion Compound as a result of termination of this Agreement or termination as to all Programs at a time during which Celgene is conducting a preclinical study or Clinical Trial [***], Celgene will [***], if such termination is pursuant to Section 11.2 (by Juno), 11.3, 11.4 (by Juno), 11.5 (by Juno), or 11.6 (by Juno), and otherwise [***]; and

(d) If Celgene has obtained a Third Party License with respect to such Juno Reversion Compound and Juno is a sublicensee under such Third Party License, then [***] under such Third Party License to the extent [***].

11.9 Celgene Reversion Compounds .

11.9.1. Reversion . If this Agreement terminates with respect to one or more Celgene Programs and/or Eligible BD Programs for which Celgene is the BD Acquiring Party [***], or if rights revert to Celgene pursuant to Section 2.9.2, then [***] such terminated Celgene Programs, Eligible BD Programs [***] shall be deemed “Celgene Reversion Compounds” and Juno shall grant, shall (within [***] after the Effective Date) cause its Affiliates to grant, and hereby grants to Celgene a non-exclusive, worldwide, royalty-free, non-transferable (except as provided in Section 12.4) license, with the right to grant sublicenses, [***], under [***], in each case that are [***], to research, develop, manufacture, use, import, offer for sale, sell, and commercialize Celgene Reversion Compounds and products containing such Celgene Reversion Compounds or Products made using such Celgene Reversion Compounds in the Territory in the Field, in each case solely to the extent that [***], as applicable.

 

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11.9.2. Effects of Reversion . With respect to any [***] that becomes a Celgene Reversion Compound:

(a) Juno shall return to Celgene within a reasonable time, at no cost to Celgene, all tangible embodiments of Celgene Know-How transferred by Celgene to Juno with respect to each such Celgene Reversion Compound;

(b) Except to the extent not permitted pursuant to any agreements between Juno and a Third Party, Juno shall provide to Celgene, within a reasonable time, at Celgene’s request, subject to [***] pertaining to the applicable Celgene Reversion Compounds [***] of such Celgene Reversion Compounds under the terms of this Agreement;

(c) With respect to [***] that becomes a Celgene Reversion Compound as a result of termination of this Agreement or termination as to all Programs at a time during which Juno is conducting preclinical studies or a Clinical Trial [***], Juno will [***], if such termination is pursuant to Section 11.2 (by Celgene), 11.3, or 11.4 (by Celgene), or 11.5 (by Celgene), and otherwise [***]; and

(d) If Juno has obtained a Third Party License with respect to such Celgene Reversion Compound and Celgene is a sublicensee under such Third Party License, then [***] under such Third Party License to the extent [***].

11.10 Surviving Provisions .

11.10.1. Accrued Rights; Remedies . Termination, relinquishment or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of any Party prior to such termination, relinquishment or expiration, including the payment obligations under Article 6 hereof, and any and all Damages or remedies (whether in law or in equity) arising from any breach hereunder. Such termination, relinquishment or expiration shall not relieve any Party from obligations which are expressly indicated to survive termination of this Agreement. Except as otherwise expressly set forth in this Agreement, the termination provisions of this Article 11 are in addition to any other relief and remedies available to either Party under this Agreement and at Law.

11.10.2. Survival . Notwithstanding any provision herein to the contrary, any rights or obligations otherwise accrued hereunder (including any accrued payment obligations) shall survive the expiration or termination of this Agreement. Further, the rights and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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obligations of the Parties set forth in the following Sections and Articles shall survive the expiration or termination of this Agreement, in addition to those other terms and conditions that are expressly stated to survive termination or expiration of this Agreement:

(a) Sections 1.7 (with respect to a Party’s right to exercise a BD Option following the expiration of this Agreement), 2.5 (as to activities conducted during the Term and activities conducted by either Party following termination, where such Party retains rights to Develop, Manufacture and Commercialize Products or Development Candidates pursuant to Section 11.7.1 (with respect to Celgene) or Section 11.7.2 (with respect to Juno)), 2.6, 2.7 (to the extent that either Party retains rights to Develop, Manufacture and Commercialize Products or Development Candidates pursuant to Section 11.7.1 (with respect to Celgene) or Section 11.7.2 (with respect to Juno)), 2.8.2 (to the extent that the Materials Receiving Party retains a license to use such Materials following termination), 2.8.3 (as to Materials transferred during the Term), 2.9, 3.1.5(b) (with respect to a Party’s right to exercise its Option for [***] following the expiration of this Agreement), 3.1.8, 7.1.1(b), 7.1.1(c), 7.1.2(b), 7.1.2(c), 7.1.2(d), 7.1.2(e), 7.1.4, 7.1.5, 7.1.6, 7.1.7, 7.2 (with the exception of Section 7.2.8), 7.3.2, 7.3.4 (to the extent applicable to Section 7.3.2), 7.3.8 (to the extent applicable to Section 7.3.2), 7.3.9 (to the extent applicable to Section 7.3.2), 7.5.4, 7.5.5 (to the extent applicable to Section 7.5.4), 7.5.6 (to the extent applicable to Section 7.5.4), 7.5.7 (to the extent applicable to Section 7.5.4), , 7.7, 7.8, Article 8 (excluding Section 8.7.1 (as to activities conducted during the Term with respect to the terminated Program or Programs), and with respect to Sections 8.6, 8.7.1 and 8.7.2, only with respect to any Programs that are the subject of executed Development & Commercialization Agreements remaining in effect), 9.4.1(e)(v), Article 10 (to the extent applicable to claims arising during the Term or any claims relating to breaches of provisions that are deemed to survive pursuant to this Agreement), and Sections 11.7, 11.8, 11.9, 11.10 and 12;

(b) With respect to any Programs that are the subject of executed Development & Commercialization Agreements remaining in effect, Sections 2.3.4, 4, 5.1, 5.2, 5.3, 5.4, and 9.4; and

(c) Additionally, if Section 11.7.1 or 11.7.2 apply to a given Program that is terminated, 2.4.2 and 3.2 (with respect to any Programs that are the subject of any executed Development & Commercialization Agreements then remaining in effect), 7.6 and Article 10 (to the extent applicable to claims arising after such expiration or termination), to the extent that a Party retains a license from the other Party to Develop, Manufacture or Commercialize Products or Development Candidates thereafter, provided that such survival shall be limited to any specific time periods set forth in such Articles and Sections, if any.

11.10.3. Relationship to Other Agreements . Termination of this Agreement with respect to a Program shall not affect in any way the terms or provisions of any then-existing executed Development & Commercialization Agreement for any other Program, or the Equity Purchase Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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ARTICLE 12

MISCELLANEOUS

12.1 Severability . If any one or more of the terms or provisions of this Agreement is held by a court of competent jurisdiction or arbitrator to be void, invalid or unenforceable in any situation in any jurisdiction, such holding shall not affect the validity or enforceability of the remaining terms and provisions hereof or the validity or enforceability of the invalid, void or unenforceable term or provision in any other situation or in any other jurisdiction and the term or provision shall be considered severed from this Agreement, unless the invalid or unenforceable term or provision is of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without the invalid or unenforceable term or provision. If the final judgment of such court or arbitrator declares that any term or provision hereof is invalid, void or unenforceable, the Parties agree to (a) reduce the scope, duration, area or applicability of the term or provision or to delete specific words or phrases to the minimum extent necessary to cause such term or provision as so reduced or amended to be enforceable, and (b) make a good faith effort to replace any invalid or unenforceable term or provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

12.2 Notices . Any notice required or permitted to be given by this Agreement shall be in writing and in English and shall be (a) delivered by hand or by overnight courier with tracking capabilities, (b) mailed postage prepaid by first class, registered, or certified mail, or (c) delivered by facsimile followed by delivery via either of the methods set forth in Sections 12.2 (a) and (b), in each case, addressed as set forth below unless changed by notice so given:

If to Celgene:

Celgene Corporation

86 Morris Avenue

Summit, NJ 07901

Attention:      Senior Vice President Business Development

Telephone:    [OMITTED]

Facsimile:     [OMITTED]

If to Celgene RIVOT:

Celgene RIVOT Ltd.

Clarendon House, 2 Church Street

Hamilton, HM 11

Bermuda

Attention:      Chief Operations Officer

Telephone:    [OMITTED]

Facsimile:     [OMITTED]

With copies to (in the case of either Celgene or Celgene RIVOT ):

Celgene Corporation

86 Morris Avenue

 

139


Summit, New Jersey 07901

Attention:      General Counsel

Telephone:    [OMITTED]

Facsimile:     [OMITTED]

And:

Dechert LLP

1900 K Street, NW

Washington, DC 20006

Attention:      David E. Schulman and Thomas Rayski

Telephone:    (202) 261-3440

Facsimile:     (202) 261-3333

If to Juno:

Juno Therapeutics, Inc.

307 Westlake Avenue North, Suite 300

Seattle, Washington 98109

Attention:     General Counsel

Telephone:   [OMITTED]

Email: legalnotice@junotherapeutics.com

With copies to:

Latham & Watkins, LLP

140 Scott Drive

Menlo Park, CA 94025

Attention: Robert Koenig and Judith Hasko

Telephone: (650) 328-4600

Facsimile: (650) 463-2600

Any such notice shall be deemed given on the date received, except any notice received after 5:30 p.m. (in the time zone of the receiving party) on a Business Day or received on a non-Business Day shall be deemed to have been received on the next Business Day. A Party may add, delete, or change the person or address to which notices should be sent at any time upon written notice delivered to the other Party in accordance with this Section 12.2.

12.3 Force Majeure . Except for the payment of money, no Party shall be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure is due to a cause beyond the reasonable control of a Party, including acts of God, fires, earthquakes, acts of war, terrorism, or civil unrest, or hurricane or other inclement weather (“ Force Majeure ”); provided, however, that the affected Party promptly notifies the other Party and further provided that the affected Party shall use its commercially reasonable efforts to avoid or remove such causes of non-performance and to mitigate the effect of such occurrence, and shall continue performance with the utmost dispatch whenever such causes are removed. When such circumstances arise, the Parties shall negotiate in good faith any modifications of the terms of this Agreement that may be necessary or appropriate in order to arrive at an equitable solution.

 

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12.4 Assignment.

12.4.1. Generally . This Agreement may not be assigned by any Party, nor may any Party delegate its obligations or otherwise transfer licenses or other rights created by this Agreement, except as expressly permitted hereunder without the prior written consent of the other Party, which consent will not be unreasonably withheld, delayed or conditioned

12.4.2. Celgene . Notwithstanding the limitations in Section 12.4.1, Celgene Corp. and Celgene RIVOT may assign this Agreement, or any rights or obligations hereunder in whole or in part, to (a) one or more Affiliates solely as provided in this Section 12.4.2 or (b) its successor in interest in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement; provided however that, except in the case where Celgene Corp., or Celgene RIVOT, as applicable, [***], (i) Celgene Corp. or Celgene RIVOT, as applicable, provides Juno with at least [***] advance written notice of any such assignment(s), (ii) prior to such assignment(s), Celgene Corp. or Celgene RIVOT, as applicable, agrees in a written agreement delivered to Juno (and upon which Juno may rely) to remain fully liable for the performance of its obligations under this Agreement by its assignee(s), and (iii) prior to such assignment(s), the assignee(s) agree in a written agreement delivered to Juno (and upon which Juno may rely) to assume performance of all such assigned obligations. If Celgene Corp. or Celgene RIVOT, as applicable, wishes to assign [***], it will be permitted to do so conditioned on [***], pursuant to which [***].

12.4.3. Juno . Notwithstanding the limitations in Section 12.4.1, Juno may assign this Agreement, or any rights or obligations hereunder in whole or in part, to (a) one or more Affiliates solely as provided in this Section 12.4.3 or (b) its successor in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement; provided however that, except in the case where Juno[***], (i) Juno provides Celgene with at least [***] advance written notice of any such assignment(s), (ii) prior to such assignment(s), Juno agrees in a written agreement delivered to Celgene (and upon which Celgene may rely) to remain fully liable for the performance of its obligations under this Agreement by its assignee(s), (iii) prior to such assignment(s), the assignee(s) agree in a written agreement delivered to Celgene (and upon which Celgene may rely) to assume performance of all such assigned obligations; (iv) in the case of any assignment(s) by Juno, [***], and (v) all of the matters referred to in clauses (i), (ii), (iii)

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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and (iv), as applicable, will be set forth in documentation [***] prior to any such assignment(s) ([***]) and in all cases will provide [***]. If Juno wishes to assign any [***], it will be permitted to do so conditioned on [***], pursuant to which such [***].

12.4.4. All Other Assignments Null and Void . The terms of this Agreement will be binding upon and will inure to the benefit of the successors, heirs, administrators and permitted assigns of the Parties. Any purported assignment in violation of this Section 12.4 will be null and void ab initio.

12.4.5. Business Combinations . Notwithstanding anything to the contrary in this Agreement, with respect to any intellectual property rights controlled by the acquiring party or its Affiliates (if other than one of the Parties to this Agreement) involved in any Business Combination of either Party, such intellectual property rights shall not be included in the technology and intellectual property rights licensed to the other Party hereunder to the extent held by such acquirer or its Affiliate (other than the relevant Party to this Agreement) prior to such transaction, or to the extent such technology is developed outside the scope of activities conducted with respect to the Collaboration, any Program, Development Candidates, Products or related Diagnostic Products. The Juno IP and the Celgene Background IP shall exclude any intellectual property owned or controlled by a permitted assignee or successor and not developed in connection with the Collaboration, any Program, Development Candidates, Products, or related Diagnostic Products, researched, Developed or Commercialized pursuant to this Agreement or any Development & Commercialization Agreement. The following modifications to the Parties rights and obligations shall apply upon the occurrence of a Business Combination of a Party:

(a) Business Combination of Celgene . If Celgene undergoes a Business Combination, effective upon the closing of the Business Combination:

(i) Section 6.2 of the Equity Purchase Agreement shall apply.

(ii) Celgene’s right to exercise an Option with respect to [***] pursuant to Section 3.1.3 shall terminate, and [***].

(iii) Celgene’s right to exercise a BD Option for a [***] BD Program pursuant to Section 2.2.1 shall terminate.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(iv) Effective upon the closing of such Business Combination, if the Parties enter into a new Development & Commercialization Agreement thereafter with respect to a Program, Celgene’s rights to exercise an Option with respect to [***] pursuant to Section 3.1.5 shall terminate, and [***] with respect to such Program.

(v) Sections 12.4.3 (iv) and (v) shall no longer apply.

(vi) Any [***] upon the closing of such Business Combination.

(b) Business Combination of Juno . If Juno undergoes a Business Combination, effective upon the closing of the Business Combination:

(i) Juno’s obligations to offer to Celgene rights to exercise a BD Option for a [***] Program pursuant to Section 2.2.1 shall terminate, and [***] will no longer apply.

(ii) Effective upon the closing of such Business Combination, after the Parties have entered into a new Development & Commercialization Agreement thereafter with respect to a Program, Juno’s rights to exercise an Option with respect to [***] pursuant to Section 3.1.5 shall terminate, and [***] with respect to such Program.

(iii) Celgene shall have [***].

12.5 Waivers and Modifications . The failure of any Party to insist on the performance of any obligation hereunder shall not be deemed to be a waiver of such obligation. Waiver of any breach of any provision hereof shall not be deemed to be a waiver of any other breach of such provision or any other provision on such occasion or any succeeding occasion. No waiver, modification, release, or amendment of any obligation under or provision of this Agreement shall be valid or effective unless in writing and signed by the Parties against whom enforcement is sought.

12.6 Waiver of Jury Trial . EACH PARTY HERETO HEREBY IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE ACTIONS OF ANY PARTY HERETO IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT HEREOF.

12.7 Choice of Law; Jurisdiction; Venue . This Agreement shall be governed by, enforced, and shall be construed in accordance with the Laws of the State of New York without regard to any conflicts of law provision that would result in the application of the Laws of any State other than the State of New York and excluding the United Nations Convention on Contracts for the International Sales of Goods; provided however that with respect to matters

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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involving the enforcement, validity or scope of intellectual property rights, the Laws of the applicable country shall apply. Each Party hereby irrevocably and unconditionally (a) consents to submit to the non-exclusive jurisdiction of the state and federal courts located in New York, New York, for any actions, suits or proceedings arising out of or relating to this Agreement and the transactions contemplated hereby and (b) waives any objection to the laying of venue of any action, suit or proceeding arising out of this Agreement or the transactions contemplated hereby in the state and federal courts of New York, New York, and agrees not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum. In addition, during the pendency of any dispute under this Agreement initiated before the end of any applicable cure period, (i) this Agreement will remain in full force and effect, (ii) the provisions of this Agreement relating to termination will not be effective, (iii) the time periods for cure as to any termination notice given prior to the initiation of the court proceeding will be tolled, and (iv) neither of the Parties will issue a notice of termination pursuant to this Agreement based on the subject matter of the court proceeding (and no effect will be given to previously issued termination notices), until the court has confirmed the existence of the facts claimed by a Party to be the basis for the asserted material breach.

12.8 Arbitration.

12.8.1. General Rules . Solely with respect to any dispute under this Agreement that is expressly designated for final resolution by arbitration pursuant to this Section 12.8 (“ Arbitration Eligible Dispute ”), such dispute shall be resolved between the parties in accordance with the American Arbitration Association (“AAA”) Commercial Arbitration Rules (or the AAA International Arbitration Rules, if recommended under the AAA guidelines), as such rules and procedures may be modified by this Section 12.8 below or by agreement between the Parties:

(a) The Party seeking final resolution of an Arbitration Eligible Dispute pursuant to this Section 12.8, shall deliver to the other Party a written notice of such intent, such notice to include each issue for which the delivering Party seeks resolution (“ Arbitration Notice ”). Following receipt of the Arbitration Notice, the receiving Party shall have [***] to the Arbitration Notice. All issues included on the Arbitration Notice by either Party must be expressly designated for arbitration under this Agreement, or the Parties must agree to such inclusion in writing. The issues listed in the Arbitration Notice and in such reply will be the only issues submitted to such arbitration (the “ Arbitration Issue(s) ”).

(b) Within [***] following finalization of the Arbitration Issues, the Parties shall mutually select a single independent, conflict-free arbitrator, who shall have sufficient scientific background and experience to resolve the matter in dispute (the “ Expert ”). For any dispute pursuant to Section 7.2.6 or 4.7.6(b), the Expert must also be an experienced patent attorney or retired judge with substantial patent prosecution experience who is knowledgeable in the field of intellectual property law relating to the worldwide Development and Commercialization of pharmaceuticals and biologic therapeutics. If the Parties are unable to reach agreement on the selection of the Expert within [***] following finalization of the Arbitration Issues, then either or both Parties shall immediately request the AAA to select an Expert with the requisite scientific background, experience and expertise. The place of arbitration shall be Seattle, Washington, and all proceedings and communications shall be in English.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(c) Within [***] after the designation of the Expert, each of Juno and Celgene shall to submit its proposed resolution of each Arbitration Issue to the Expert, as well as a summary of its position with respect to each such issue (each such proposed resolution, a “ Proposed Resolution ”). Upon receipt of each Party’s Proposed Resolution, the Expert shall provide copies of the same to the other Party.

(d) Each party shall submit a written rebuttal to the other Party’s Proposed Resolution to the Expert within [***] of receiving the other Party’s Proposed Resolution. Within [***] after the Expert’s receipt of both Parties written response, the Expert shall set a date for a hearing for the presentation of evidence and legal argument concerning each Arbitration Issue.

(e) The Expert shall use all reasonable efforts to provide a final determination as to each Arbitration Issue within [***] of the hearing date, pursuant to Section 12.8.2(a) or (b), as applicable. The Parties understand and agree that any determination rendered by the Expert shall be final and binding on the Parties.

12.8.2. Final Decision .

(a) Expert Arbitration . For any dispute under this Agreement that is expressly designated to be submitted for expert arbitration pursuant to this Section 12.8.2(a), the provisions of Section 12.8.1 shall apply, except as follows: In making a final decision pursuant to Section 12.8.1(e), the Expert is authorized to and shall propose any resolution to each Arbitration Issue that, to the extent possible, reflects the terms and conditions of this Agreement, the Expert’s views as to how each Arbitration Issue should be resolved in the global pharmaceutical industry between two (2) independent companies focused on research, Development and Commercialization of therapeutics, and is fair and reasonable to the Parties in light of the totality of the circumstances and, where applicable, reflects financial valuation methodologies customarily utilized by leading investment banking firms who deliver so-called “fairness opinions” (the “ Standard ”).

(b) Baseball Arbitration . For any dispute under this Agreement that is expressly designated to be submitted for baseball arbitration pursuant to this Section 12.8.2(b), the provisions of the Section 12.8.1 shall apply, except as follows: In making the final decision pursuant to Section 12.8.1(e), the Expert’s final decision making authority will be limited to, selecting whichever of either Juno’s or Celgene’s Proposed Resolution more closely reflects the terms and conditions of this Agreement and, for those matters not addressed by the terms and conditions of this Agreement, more closely reflects the Standard.

12.8.3. Arbitration Costs . Each Party shall bear its own counsel fees, costs, and disbursements arising out of the dispute resolution procedures described in this Section 12.8, and shall pay an equal share of the fees and costs of the Expert and all other general fees related to any arbitration described in Section 12.8.1. Unless the Parties otherwise agree in writing, during the period of time that any arbitration proceeding described in this Section 12.8 is pending under

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

145


this Agreement, the Parties shall continue to comply with all those terms and provisions of this Agreement that are not the subject of such pending arbitration proceeding. All arbitration proceedings and decisions of the Expert under this Section 12.8 shall be deemed Confidential Information of both Parties under Article 8.

12.9 Relationship of the Parties . Juno and Celgene are independent contractors under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute (a) Juno as partner, agent, or joint venturer of Celgene or (b) Celgene as a partner, agent or joint venturer of Juno. Neither Juno nor Celgene shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of Celgene or Juno, respectively, or to bind Celgene or Juno, respectively, to any contract, agreement, or undertaking with any Third Party. There are no express or implied third party beneficiaries hereunder.

12.10 Entire Agreement . This Agreement, together with the attached Exhibits (including the form of each Development & Commercialization Agreement, and the Equity Purchase Agreement) and Schedules, contains the entire agreement by the Parties with respect to the subject matter hereof and supersedes any prior express or implied agreements, understandings and representations, either oral or written, which may have related to the subject matter hereof in any way, including the Existing Confidentiality Agreement (as set forth in Section 8.8) and any and all term sheets relating to the transactions contemplated by this Agreement and exchanged between the Parties prior to the Effective Date.

12.11 Counterparts . This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together, and shall constitute one and the same instrument. Any such counterpart, to the extent delivered by means of a fax machine or by .pdf, .tif, .gif, .jpeg or similar attachment to electronic mail (any such delivery, an “ Electronic Delivery ”) shall be treated in all manner and respects as an original executed counterpart and shall be considered to have the same binding legal effect as if it were the original signed version thereof delivered in person. No Party hereto shall raise the use of Electronic Delivery to deliver a signature or the fact that any signature or agreement or instrument was transmitted or communicated through the use of Electronic Delivery as a claim or defense with respect to the formation of a contract, and each Party forever waives any such claim or defense, except to the extent that such claim or defense relates to lack of authenticity.

12.12 Equitable Relief . Notwithstanding anything to the contrary herein, the Parties shall be entitled to seek equitable relief, including injunction and specific performance, as a remedy for any breach of this Agreement. Such remedies shall not be deemed to be the exclusive remedies for a breach of this Agreement but shall be in addition to all other remedies available at law or equity. The Parties further agree not to raise as a defense or objection to the request or granting of such relief that any breach of this Agreement is or would be compensable by an award of money damages.

12.13 Interpretation.

12.13.1. Generally . This Agreement has been diligently reviewed by and negotiated by and among the Parties, and in such negotiations each of them has been represented

 

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by competent counsel, and the final agreement contained herein, including the language whereby it has been expressed, represents the joint efforts of the Parties and their counsel. Accordingly, in interpreting this Agreement or any provision hereof, no presumption shall apply against any Party as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.

12.13.2. Definitions; Pronouns . The definitions of the terms herein shall apply equally to the singular and plural forms of the terms defined and where a word or phrase is defined herein, each of its other grammatical forms shall have a corresponding meaning. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine, and neuter forms. The word “will” shall be construed to have the same meaning and effect as the word “shall.” The word “any” shall mean “any and all” unless otherwise clearly indicated by context. The word “including,” “includes,” “include,” “for example,” and “e.g.” will be deemed to be followed by the words “without limitation.” The word “or” is disjunctive but not necessarily exclusive. The words “hereof,” “herein” and “herewith” and words of similar import shall, unless otherwise stated, be construed to refer to this Agreement as a whole and not to any particular provision of this Agreement.

12.13.3. Subsequent Events . Unless the context requires otherwise, (i) any definition of or reference to any agreement, instrument, or other document herein shall be construed as referring to such agreement, instrument, or other document as from time to time amended, supplemented, or otherwise modified (subject to any restrictions on such amendments, supplements, or modifications set forth herein or therein), (ii) any reference to any Laws herein shall be construed as referring to such Laws as from time to time enacted, repealed, or amended, (iii) any reference herein to any Person shall be construed to include the Person’s successors and assigns, and (iv) all references herein to Articles, Sections, Schedules or Exhibits, unless otherwise specifically provided, shall be construed to refer to Articles, Sections, Schedules and Exhibits of this Agreement.

12.13.4. Headings . Headings, captions and the table of contents are for convenience only and are not to be used in the interpretation of this Agreement.

12.13.5. Prior Drafts . No prior draft of this Agreement nor any course of performance or course of dealing shall be used in the interpretation or construction of this Agreement.

12.13.6. Independent Significance . Although the same or similar subject matters may be addressed in different provisions of this Agreement, the Parties intend that, except as reasonably apparent on the face of the Agreement or as expressly provided in this Agreement, each such provision shall be read separately, be given independent significance and not be construed as limiting any other provision of this Agreement (whether or not more general or more specific in scope, substance or content).

12.14 Celgene Parties . The Parties hereby acknowledge and agree that (a) Celgene Corp. is the party to this Agreement with respect to all rights and obligations (including payment obligations) under this Agreement in the United States; and (b) Celgene RIVOT is the party to

 

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this Agreement with respect to all rights and obligations (including payment obligations and the right to enter into any [***] Co-Co Agreement or any License Agreement) under this Agreement outside of the United States.

12.15 Further Assurances . Each Party shall execute, acknowledge and deliver such further instruments, and do all such other acts, as may be necessary or appropriate in order to carry out the expressly stated purposes and the clear intent of this Agreement.

[ Signature Page Follows ]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have caused this AMENDED AND RESTATED MASTER RESEARCH AND COLLABORATION AGREEMENT to be executed by their respective duly authorized officers as of the Execution Date.

 

CELGENE CORPORATION
By:   /s/ Robert J. Hugin
  Name: Robert J. Hugin
  Title: CEO

 

[ Signature Page to Amended and Restated Master Research and Collaboration Agreement ]


IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have caused this AMENDED AND RESTATED MASTER RESEARCH AND COLLABORATION AGREEMENT to be executed by their respective duly authorized officers as of the Execution Date.

 

CELGENE RIVOT LTD.
By:   /s/ Kevin Mello
  Name: Kevin Mello
  Title: Director

 

[ Signature Page to Amended and Restated Master Research and Collaboration Agreement ]


IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have caused this AMENDED AND RESTATED MASTER RESEARCH AND COLLABORATION AGREEMENT to be executed by their respective duly authorized officers as of the Execution Date.

 

JUNO THERAPEUTICS, INC.
By:   /s/ Hans Bishop
  Name: Hans Bishop
  Title: President & CEO

 

[ Signature Page to Amended and Restated Master Research and Collaboration Agreement ]


EXHIBIT A

FORM OF LICENSE AGREEMENT

LICENSE AGREEMENT

by and among

JUNO THERAPEUTICS, INC.

and

CELGENE CORPORATION

and

CELGENE RIVOT LTD.

Dated as of [ ], [ ]


TABLE OF CONTENTS

 

            Page  

ARTICLE 1 DEFINITIONS

     2   

1.1

     “Celgene Relevant Licensed IP”      2   

1.2

     “Commercialization Opt-In Terms”      2   

1.3

     “Comparable License Third Party Product”      3   

1.4

     “First License Sale”      3   

1.5

     “Juno Licensed IP”      3   

1.6

     “License Annual Unit Sales”      3   

1.7

     “License Commercialization Plan”      3   

1.8

     “License Development Plan”      4   

1.9

     “License [***]”      4   

1.10

     “License Net Sales”      4   

1.11

     “Licensed Combination Product”      5   

1.12

     “Licensed Diagnostic Product Royalty Term”      5   

1.13

     “Licensed Product Data”      5   

1.14

     “Licensed Product Royalty Term”      5   

1.15

     “Licensed Program”      5   

1.16

     “Licensed Regulatory-Based Exclusivity”      5   

1.17

     Additional Definitions.      6   

1.18

     Definitions from Master Collaboration Agreement.      7   

ARTICLE 2 DEVELOPMENT, REGULATORY AND SUPPLY

     11   

2.1

     Licensed Program, Licensed Target and Candidates.      11   

2.2

     Development.      11   

2.3

     Regulatory.      16   

2.4

     Manufacturing and Supply.      20   

2.5

     Records; Reports; Results.      20   

2.6

     Materials Transfer and Licenses.      20   

2.7

     No Representation      22   

2.8

     Covenant During License Term      22   

2.9

     Additional [***] Programs.      22   

ARTICLE 3 COMMERCIALIZATION; CELGENE RIGHT TO CO-PROMOTE

     22   

3.1

     Commercialization.      22   

3.2

     Celgene Right to Co-Promote; Conversion to Juno Lead Co-Co Agreement.      23   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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TABLE OF CONTENTS

 

            Page  

3.3

     Opt-In Right for Certain Commercialization Activities under License Agreement.      24   

3.4

     Additional Terms of Commercialization.      24   

ARTICLE 4 EXCLUSIVITY

     26   

4.1

     Exclusivity.      26   

ARTICLE 5 FINANCIAL TERMS

     26   

5.1

     CD19 Program      26   

5.2

     CD22 Program      26   

5.3

     Other Juno Programs      26   

5.4

     Royalties Payment Terms      26   

5.5

     Additional Payment Terms      28   

5.6

     Records Retention by Celgene; Review by Juno      29   

ARTICLE 6 INTELLECTUAL PROPERTY

     30   

6.1

     License      30   

6.2

     Ownership      32   

6.3

     Prosecution and Maintenance of Patents      32   

6.4

     Defense of Claims Brought by Third Parties      32   

6.5

     Enforcement of Patents      32   

6.6

     Patent Term Extensions      37   

6.7

     [***]      38   

6.8

     [***] Patents      38   

6.9

     Regulatory Data Protection      38   

6.10

     Third Party Payments.      38   

ARTICLE 7 UPSTREAM AGREEMENTS

     39   

7.1

     Upstream Obligations      39   

ARTICLE 8 INDEMNIFICATION; INSURANCE

     39   

8.1

     Indemnification by Celgene      39   

8.2

     Indemnification by Juno      39   

8.3

     Notice of Claims      40   

8.4

     Indemnification Procedures      40   

8.5

     LIMITATION OF LIABILITY      41   

ARTICLE 9 LICENSE TERM AND TERMINATION

     41   

9.1

     License Term; Expiration      41   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-ii-


TABLE OF CONTENTS

 

            Page  

9.2

     Termination Without Cause      43   

9.3

     Termination for Breach      43   

9.4

     Termination for Patent Challenges      44   

9.5

     Termination for Bankruptcy      45   

9.6

     Termination for Breach of Standstill.      46   

9.7

     Effects of Expiration or Termination      46   

9.8

     Juno Reversion Products      47   

9.9

     Survival of Sublicensees      48   

9.10

     Surviving Provisions      48   

9.11

     Relationship to Other Agreements      49   

ARTICLE 10 MISCELLANEOUS

     50   

10.1

     Confidentiality; Publicity      50   

10.2

     Disclaimer of Warranties      50   

10.3

     Applicability of Terms of Master Collaboration Agreement      50   

10.4

     Assignment      50   

10.5

     Entire Agreement      52   

 

-iii-


LIST OF EXHIBITS

 

Exhibit A

   Licensed Program

Exhibit B

   Licensed Target, Licensed Candidates and [***]

Exhibit C-1

   Financial Terms – CD19 Program

Exhibit C-2

   Financial Terms – CD22 Program

Exhibit C-3

   Financial Terms – Other Juno Programs and [***] Programs

Exhibit D

   Press Release

Exhibit E

   Form of License Material Transfer Agreement

Exhibit F

   Commercialization Opt-In Terms

LIST OF SCHEDULES

 

Schedule 6.1.1

     Patents Licensed to Celgene

Schedule 6.1.2

     Patents Licensed to Juno

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-iv-


LICENSE AGREEMENT

This LICENSE AGREEMENT (this “ License Agreement ”) is entered into and made effective as of [●], 20              (the “ License Agreement Effective Date ”) by and among Juno Therapeutics, Inc. , a Delaware corporation (“ Juno ”), and Celgene Corporation , a Delaware corporation (“ Celgene Corp. ”), with respect to all rights and obligations under this License Agreement in the United States, and Celgene RIVOT Ltd. (“ Celgene RIVOT ”), with respect to all rights and obligations under this License Agreement outside of the United States, (Celgene RIVOT and Celgene Corp. together, “ Celgene ”). Celgene and Juno are each referred to herein as a “ Party ” or, collectively, as the “ Parties .”

RECITALS

WHEREAS , Juno, Celgene Corp. and Celgene RIVOT entered into that certain Master Research and Collaboration Agreement, dated as of June 29, 2015 (as amended, the “ Master Collaboration Agreement ”), pursuant to which Celgene has an exclusive option to obtain an exclusive license to develop, manufacture and commercialize Development Candidates arising out of activities conducted pursuant to certain Juno Programs in the ROW Territory (each, as defined in the Master Collaboration Agreement);

WHEREAS , pursuant to the terms of the Master Collaboration Agreement, upon exercise by Celgene of certain options with respect to a Juno Program, the Parties are obligated to enter into either a license agreement or a co-development and co-commercialization agreement with respect to such Juno Program;

WHEREAS , pursuant to Section 3.1.1 (where the Program is a Juno Program), or Section 3.1.5 (where the Program is an [***] Program (as defined in the Master Collaboration Agreement) [***]) of the Master Collaboration Agreement, with respect to the Licensed Program, the Parties are obligated to enter into a license agreement upon exercise by Celgene of an Option with respect to such Program;

WHEREAS , Celgene has delivered an Option Exercise Notice pursuant to Section 3.1.3 or 3.1.5, in each case of the Master Collaboration Agreement for the Licensed Program, and accordingly, Celgene and Juno are obligated to enter into this License Agreement for such Licensed Program pursuant to which Juno grants to Celgene (a) exclusive rights in the ROW Territory with respect to the development, manufacture and commercialization of Development Candidates, Products and Diagnostic Products (as defined in the Master Collaboration Agreement), and (b) under certain circumstances set forth in this License Agreement, the right to exercise an option to co-Commercialize (with Juno and Juno’s Affiliates) such Licensed Products in the North America Territory in certain Indications (as defined in the Master Collaboration Agreement), in each case on the terms and subject to the conditions set forth herein;

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


WHEREAS , under certain circumstances set forth in this License Agreement, Celgene grants to Juno the right to exercise an option to co-Commercialize (with Celgene and Celgene’s Affiliates) such Licensed Products in the Major EU Market Countries; and

NOW, THEREFORE , in consideration of the foregoing and the mutual agreements set forth below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

ARTICLE 1

DEFINITIONS

Capitalized terms used, but not defined, herein will have the meanings ascribed to them in the Master Collaboration Agreement.

1.1 “Celgene Relevant Licensed IP” means, with respect to the Licensed Program, all Celgene IP Controlled by Celgene and/or its Affiliates as of the License Agreement Effective Date or at any time thereafter during the License Term that (i) [***] (1) Licensed Candidates, (2) Licensed Products and/or (3) Licensed Diagnostic Products for such Licensed Candidates or Licensed Products, or (ii) is [***] (1) Licensed Candidates, (2) Licensed Products and/or (3) Licensed Diagnostic Products for such Licensed Candidates or Licensed Products, [***], and in each case subject to the following sentence. Notwithstanding anything to the contrary in this Section 1.1, Patents included in the Celgene Relevant Licensed IP shall not include (A) any Patents to the extent such Patents [***], or (B) any Patents to the extent such Patents [***].

1.2 “Commercialization Opt-In Terms” means the additional terms of participation by a Party in Commercialization Activities relating to Licensed Products following exercise of the Commercialization Opt-In Right pursuant to Section 3.3.1 (by Juno with respect to the Major EU Market Countries), or Section 3.3.2 (by Celgene with respect to the North America Territory), as set forth on Exhibit F .

1.3 “Comparable License Third Party Product” means, on a Licensed Product-by-Licensed Product and country-by-country basis:

(a) For any Licensed Product containing a Licensed Candidate [***], any pharmaceutical product (i) that contains [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2


[***] such approved Licensed Product; (ii) [***], or (b) [***]; and (iii) is sold in the [***] country [***] Licensed Product by [***]. A pharmaceutical product that is [***] shall be a Comparable License Third Party Product with respect to such Licensed Product in such country; and

(b) For any Licensed Product containing a Licensed Candidate [***], any pharmaceutical or biological product (i) that contains (a) [***] such Licensed Product, or (b) [***], (ii) for which [***], (iii) is [***], or any other equivalent [***] in such country, and (iv) is sold in the [***] country [***] Licensed Product by [***].

1.4 “First License Sale” means, on a Licensed Product-by-Licensed Product and Licensed Diagnostic Product-by-Licensed Diagnostic Product basis, the first sale [***] by Celgene or its Affiliates or Sublicensees for use or consumption by [***] of such Licensed Product (or Licensed Diagnostic Product, as applicable) in the ROW Territory for which [***] Regulatory Approvals [***] to sell such Licensed Product (or Licensed Diagnostic Product, as applicable) [***] have been granted; in each case, provided, however, that the following shall not constitute a First License Sale: (a) any sale to an Affiliate or Sublicensee unless the Affiliate or Sublicensee is the last entity in the distribution chain of the Licensed Product (or Licensed Diagnostic Product, as applicable); (b) any use of such Licensed Product or Licensed Diagnostic Product in Clinical Trials, non-clinical development activities or other development activities with respect to such Licensed Product or Licensed Diagnostic Product by or on behalf of a Party, or disposal or transfer of such Licensed Product or Licensed Diagnostic Product for a bona fide charitable purpose; and (c) compassionate use, in each case for which no payment is received by Celgene, its Affiliates or Sublicensees.

1.5 “Juno Licensed IP” means, with respect to the Licensed Program, all Juno IP Controlled by Juno and/or its Affiliates as of the License Agreement Effective Date or at any time thereafter during the License Term that (i) [***] (1) Licensed Candidates, (2) Licensed Products and/or (3) Diagnostic Products for such Licensed Candidates or Licensed Products (such Diagnostic Products, “ Licensed Diagnostic Products ”) or (ii) [***], and in each case subject to the following sentence. Notwithstanding anything to the contrary in this Section 1.6 Patents included in the Juno Licensed IP shall not include (A) any Patents to the extent such Patents [***], or (B) any Patents to the extent such Patents [***].

1.6 “License Annual Unit Sales” means, on a Licensed Product-by-Licensed Product and Licensed Diagnostic Product-by-Licensed Diagnostic Product basis, the total number of units of such Licensed Product or such Licensed Diagnostic Product sold by Celgene, its Affiliates and Sublicensees in the Territory in a particular [***].

1.7 “License Commercialization Plan” means, on a Licensed Product-by-Licensed Product basis, the plan for the Commercialization of such Licensed Product (and corresponding Licensed Diagnostic Products if applicable) in the ROW Territory and North America Territory during a given [***], as prepared by Celgene (with respect to the ROW Territory) and by Juno (with respect to the North America Territory) and approved by the JCC in accordance with Section 3.4.2.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

3


1.8 “License Development Plan” means, on a Licensed Product-by-Licensed Product basis, the plan for the Development of such Licensed Product (and corresponding Licensed Candidates and if applicable Licensed Diagnostic Products) in the ROW Territory and the North America Territory during a given [***], as prepared by Celgene (with respect to the ROW Territory) and by Juno (with respect to the North America Territory) and approved by the JRDC in accordance with Section 2.2.5.

1.9 “License [***]” means the [***] for the Licensed Program listed on Exhibit B, as such list may be amended from time to time if Celgene exercises its Option with respect to an [***] Program that includes [***] (where such [***] Program was internally developed by Juno), pursuant to Section 3.1.5 of the Master Collaboration Agreement.

1.10 “License Net Sales” means, with respect to any Licensed Product or Licensed Diagnostic Product, the [***] amounts [***] by Celgene, its Affiliates and Sublicensees (each, a “ License Selling Party ”) to Third Party customers for sales of such Licensed Product or Licensed Diagnostic Product, less the following deductions [***] in accordance with (as applicable to the License Selling Party) the Accounting Principles, for:

(a) [***];

(b) [***];

(c) [***];

(d) [***];

(e) [***]; and

(f) [***].

If non-monetary consideration is received by a License Selling Party for any Licensed Product or Licensed Diagnostic Product in the relevant country, License Net Sales will be calculated based on the [***]. Notwithstanding the foregoing, License Net Sales shall not be imputed to transfers of Licensed Products or Licensed Diagnostic Products, as applicable, for use in [***].

License Net Sales shall be determined on, and only on, the first sale by Celgene or any of its Affiliates or Sublicensees to a non-Sublicensee Third Party.

If a Licensed Product is sold as part of a Licensed Combination Product, License Net Sales will be the product of (i) License Net Sales of the Licensed Combination Product calculated as above (i.e., calculated as for a non-Licensed Combination Product) and (ii) the fraction [***], where:

[***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

4


1.11 “Licensed Combination Product” means any Licensed Product comprising a Licensed Candidate and one or more other active ingredient(s) that is not itself a Licensed Candidate (such other active ingredients, “ Other Actives ”). For clarification, the term “Other Active,” when referring to an ingredient included in such Licensed Product refers to ingredients that are incorporated or included in the Licensed Product for [***] (whether in the same or different formulations, or dosed separately or together) for the purpose of [***]; the term excludes such ingredients that are present in such a Licensed Product [***].

1.12 “Licensed Diagnostic Product Royalty Term” means, with respect to Licensed Diagnostic Products related to Licensed Products, on a Licensed Diagnostic Product-by-Licensed Diagnostic Product and country-by-country basis, the period of time commencing on the First License Sale of such Licensed Diagnostic Product in such country and expiring upon the later of (a) the expiration of the last Valid Claim of a Patent [***] of such Licensed Diagnostic Product in such country, and (b) the [***] anniversary of the date of First License Sale of such Licensed Diagnostic Product in such country.

1.13 “Licensed Product Data” means, subject to Section 2.2.6, all relevant data included in the Know-How Controlled by either Party or its Affiliates in relation to the Licensed Products for use in the Field that: (a) is in existence at the License Agreement Effective Date; (b) is [***], Licensed Products or Licensed Diagnostic Products in the Field; or (c) otherwise relates to any Licensed Product or Licensed Diagnostic Product and is [***] Regulatory Approval of the Licensed Products or Licensed Diagnostic Products in the Field. Licensed Product Data Controlled by Celgene or its Affiliates shall be “ Celgene Licensed Product Data ” and Licensed Product Data Controlled by Juno or its Affiliates shall be “ Juno Licensed Product Data ”.

1.14 “Licensed Product Royalty Term” means, on a Licensed Product-by-Licensed Product and country-by-country basis, the period of time commencing on the First License Sale of such Licensed Product in such country and expiring upon (a) where the Licensed Product (i) [***], or (ii) [***], or (b) where the Licensed Product [***], upon the latest of (i) the expiration of the last Valid Claim of a [***] of such Licensed Product in such country, (ii) the expiration of License Regulatory-Based Exclusivity of such Licensed Product in such country, and (iii) the [***] of the date of First License Sale of such Licensed Product in such country.

1.15 “Licensed Program” has the meaning set forth in Section 2.1.1.

1.16 “Licensed Regulatory-Based Exclusivity” means, on a Licensed Product-by-Licensed Product and country-by-country basis, that (a) Celgene or any of its Affiliates or Sublicensees has been granted the exclusive legal right by a Regulatory Authority (or is otherwise entitled to the exclusive legal right by operation of Law) in such country to market and sell the Licensed Product or the active ingredient comprising such Licensed Product in such country, or (b) the data and information submitted by Celgene or any of its Affiliates or Sublicensees to the relevant Regulatory Authority in such country for purposes of obtaining Regulatory Approval for such Licensed Product may not be disclosed, referenced or relied upon in any way by any Person other than to support the Regulatory Approval or marketing of any

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

5


product by a Third Party in such country other than (i) Celgene, its Affiliates or Sublicensees, or (ii) solely to the extent permitted in this License Agreement, Juno, its Affiliates or Sublicensees (including in each case by relying upon the Regulatory Authority’s previous findings regarding the safety or effectiveness of the Licensed Product).

1.17 Additional Definitions. Each of the following terms has the meaning described in the corresponding section of this License Agreement indicated below:

 

Defined Term:

   Section:

Additional Study

   2.2.6(c)

Adverse Study Effect

   2.2.6(c)(3)

[***]

   2.2.7

Celgene

   Preamble

Celgene Corp.

   Preamble

Celgene Licensed Product Data

   1.13

Celgene RIVOT

   Preamble

[***]

   3.3.2

Commercialization Opt-In Activities

   Exhibit F

Commercialization Opt-In Right

   3.3.2

Commercialization Report

   3.4.4

Cure Period

   9.3.1

Floor Royalty

   5.4.3

Indemnification Claim

   8.3

Indemnitee

   8.3

Indemnitor

   8.3

[***]

   5.5.3

Juno

   Preamble

Juno Licensed Product Data

   1.13

Juno Reversion Products

   9.8.1

[***]

   Exhibit C-1

License Agreement

   Preamble

License Agreement Effective Date

   Preamble

License Competitive Infringement

   6.5.1

License Covering Patent

   6.6.1

License Enforcement Proceeding

   6.5.2(h)

License Material Transfer Agreement

   2.6.1

License Material Transfer Agreement Effective Date

   Exhibit E

License Materials

   2.6.1

License Materials Receiving Party

   2.6.1

License Purpose

   2.6.1

License Selling Party

   1.10

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

6


Defined Term:

   Section:

License Step-In Proceeding

   6.5.2(h)

License Term

   9.1.1

License Third Party Payment

   6.10

License Transferring Party

   2.6.1

Licensed Candidates

   Exhibit B

Licensed Diagnostic Product

   1.5

Licensed Product Patents

   6.5.2(a)

Licensed Program

   Exhibit A

Licensed Program Assets

   2.8

Licensed Target

   Exhibit B

Master Collaboration Agreement

   Recitals

[***]

   3.3.2

Non-Proposing Party

   2.2.6(c)(1)

Other Actives

   1.11

Package

   5.4.5

Party or Parties

   Preamble

Patent Term Extension

   6.6.1

Paying Party

   5.5.3

Payee Party

   5.5.3

Research Cost Report

   2.2.4

Pharmacovigilance Agreement

   2.3.5(a)

Proposing Party

   2.2.6(c)

Safety and CMC Data

   2.3.3(b)

[***]

   9.2.2

[***]

   5.5.3(b)

1.18 Definitions from Master Collaboration Agreement. Capitalized terms used herein but not defined, including each of the following terms, have the meaning described in the Master Collaboration Agreement:

Defined Term:

Accounting Principles

Affiliate

Antibody Construct

Antitrust Law

Bankruptcy Code

Biologic Therapeutic

Biologics License Application or BLA

Business Combination

Business Day

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

7


Defined Term:

Calendar Quarter

Calendar Year

CD19 Program

CD22 Program

Celgene Background IP

Celgene Indemnitees

Celgene IP

Celgene Co-Promote Program

Celgene Co-Promote Right

Celgene Option Exercise Notice

Celgene Patents

Celgene Platform Technology

Celgene Upstream Agreement

Cellular Therapy Development Candidate

Cellular Therapy Products

Clinical Trial

CMC Activities

Collaboration IP

Commercialization

Commercialization Activities

Commercialization Lead Party

Commercialization Opt-In Right

Commercially Reasonable Efforts

Confidential Information

Control, Controls or Controlled

Core Dossier Study

Cover, Covering or Covered

Damages

[***]

Development

Development & Commercialization Agreement

Development Candidate

Development Lead Party

Diagnostic Product

Dollars or $

EMA

Equity Purchase Agreement

Executive Officers

FDA

Field

FTE Rate

Good Clinical Practices or GCP

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

8


Defined Term:

Good Laboratory Practices or GLP

Good Manufacturing Practices or GMP

Hatch-Waxman Act

[***] Agent or [***]

In Vivo Product

IND

Indication

Inventions

Joint Collaboration IP

JRDC

JSC

Juno Background IP

Juno Indemnitees

Juno IP

Juno Patents

Juno Platform Technology

Juno Program

Juno Program Assets

Juno Upstream Agreements

Know-How

Law or Laws

Licensed Product

Litigation Conditions

MAA

Major EU Market Countries

Manufacture or Manufacturing

Manufacturing Agreement

New Drug Application or NDA

North America Territory

Offering Party

Option

Option Exercise Notice

Patent

Patent Committee

Person

Phase 3 Clinical Trial

Phase 4 Clinical Trial

Pivotal Clinical Trial

Products

Product Liability

Program

Prosecution and Maintenance

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

9


Defined Term:

Regulatory Approval

Regulatory Authority

Regulatory Materials

Research

Resulting Patents

ROW Territory

Small Molecule Compound

Specifically Directed

Sublicensee

Target

Territory

Third Party

Third Party License

[***]

[***] Program

[***] Option Exercise Notice

[***] Program

United States or U.S.

Valid Claim

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

10


ARTICLE 2

DEVELOPMENT, REGULATORY AND SUPPLY

2.1 Licensed Program, Licensed Target and Candidates.

2.1.1 Licensed Program . The Licensed Program is the Program set forth on Exhibit A .

2.1.2 Licensed Target . The Licensed Target is set forth on Exhibit B .

2.1.3 Licensed Candidates . The Licensed Candidates, as of the License Agreement Effective Date, are set forth on Exhibit B .

2.1.4 [***]. The [***] under this License Agreement are set forth on Exhibit B , as such [***] may be amended from time to time.

2.2 Development.

2.2.1 Diligence . Celgene, directly or through one or more of its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to Develop and Commercialize Licensed Product in the Field in the ROW Territory and otherwise to perform its obligations under the License Development Plan. Juno, directly or through one or more of its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to perform its obligations under the License Development Plan. Juno, directly or through one or more of its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to perform Manufacturing services with respect to Licensed Products that are [***] Products for the ROW Territory, if any, as set forth in Section 2.4 of this License Agreement, Section 2.10 of the Master Collaboration Agreement, and the Manufacturing Agreement, if executed. Celgene, directly or through one or more of its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to Manufacture Licensed Products that are [***] Products for clinical and commercial purposes for use outside the ROW Territory as set forth in Section 2.4 of this License Agreement and Section 2.10 of the Master Collaboration Agreement. Each Party will reasonably cooperate with the other Party in performing the foregoing obligations.

2.2.2 Assistance . During the License Term, each Party will cooperate with the other Party to provide reasonable assistance requested by such other Party, to facilitate the transfer of Development, Manufacture (if applicable) and Commercialization efforts related to Licensed Candidates, Licensed Products and Licensed Diagnostic Products, including assistance with respect to regulatory and Clinical Trial transition matters, and with the transfer to the other Party of any additional Know-How licensed to such other Party under Section 2.6. Such cooperation will include providing the other Party with reasonable access in-person or by teleconference to such Party’s personnel involved in the Research, Development and Manufacture of Licensed Candidates, Licensed Products and Licensed Diagnostic Products. Each Party shall provide the other Party with a reasonable level of assistance and consultation in connection with the transfer described in this Section 2.2.2 [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

11


2.2.3 Roles and Responsibility . As of and after the License Agreement Effective Date, except as set forth in Sections 2.2.6, and subject to Section 2.3, Celgene will be the Development Lead Party for Licensed Products pursuant to this License Agreement in the ROW Territory, and will assume sole responsibility for, and control of, all activities relating to the Development of Licensed Candidates, Licensed Products and Licensed Diagnostic Products in the Field in the ROW Territory, and, except as otherwise set forth in this License Agreement, [***]. Juno will be the Development Lead Party of Licensed Products pursuant to this License Agreement outside of the ROW Territory, and will have sole responsibility for, and control of, all activities relating to the Development of Licensed Candidates, Licensed Products and Licensed Diagnostic Products in the Field outside of the ROW Territory, and, except as otherwise set forth in this License Agreement, [***] the Development of Licensed Candidates, Licensed Products and Licensed Diagnostic Products in the Field outside of the ROW Territory.

2.2.4 Research . The Parties shall discuss, through the JRDC, the scope of Research activities, that are to be conducted in relation to the Licensed Candidates, Licensed Products and Licensed Diagnostic Products, and such Research activities and allocation thereof between the Parties shall be set forth in a Research plan that is a component of the License Development Plan. The costs of conducting Research activities in both the ROW Territory and the North America Territory in relation to the License Program shall be reflected in a Research budget approved with the applicable Research plan. Promptly following the License Agreement Effective Date, the JRDC shall agree upon a form of cost report to be prepared and submitted by each Party to the JRDC on a Calendar Quarterly basis setting forth the costs incurred by each Party in conducting Research activities in accordance with the License Development Plan and the Research budget in the previous Calendar Quarter (the “ Research Cost Report ”). Within [***] after the end of each Calendar Quarter following the License Agreement Effective Date (or the determination by the JRDC of the scope of Research activities to be conducted by the Parties under the License Development Plan, if later), each Party shall submit its Research Cost Report for the previous Calendar Quarter to the other Party. The Parties shall [***] conducting Research activities pursuant to the Research plan. Unless the Parties otherwise agree in writing, each Party shall be [***]. Decisions regarding Research will [***].

2.2.5 License Development Plan.

(a) Scope and Preparation . Promptly after the License Agreement Effective Date, Juno (with respect to Development of the Licensed Candidates, Licensed Products and Licensed Diagnostic Products in the North America Territory) and Celgene (with respect to Development of the Licensed Candidates, Licensed Products and Licensed Diagnostic Products in the ROW Territory) shall each prepare and submit to the JRDC for review and approval a portion of an initial global License Development Plan. All [***] either Party or its Affiliates in conducting Development activities (excluding Research activities, which are addressed in Section 2.2.4) pursuant to the License Development Plan shall be [***], subject to Section 2.2.6. The JRDC will set the required form and contents of the License Development Plan, and will review and approve each updated License Development Plan. Subject to the Development Lead Party’s right to make a final decision pursuant to Section 4.2.5 of the Master Collaboration

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

12


Agreement with respect to its territory (for Juno, outside the ROW Territory and for Celgene, the ROW Territory), the License Development Plan shall incorporate any reasonable comments made by either Party. For clarity, as used in Section 2.2.4 and Section 2.2.5, the term “Research activities” shall not be deemed to include [***].

(b) Updates . Following the initial preparation of the License Development Plan as set forth in Section 2.2.5(a), the JRDC will update the License Development Plan at least [***] during the License Term prior to the grant of Regulatory Approval for the applicable Licensed Products, with Juno proposing the updates for the License Development Plan with respect to Licensed Products in the North America Territory and Celgene proposing the updates for the License Development Plan with respect to Licensed Products in the ROW Territory. In addition, either Party may reasonably request at any time that the JRDC consider and approve other updates to the License Development Plan for Development activities to support Regulatory Approval on a global basis. Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will perform any material Development activities for any Licensed Candidates, Licensed Products or Licensed Diagnostic Products unless described in the License Development Plan, as specified in Section 2.2.6(c) or required by applicable laws or applicable Regulatory Authorities or independent monitoring boards for Clinical Trials.

2.2.6 Conduct of Certain Development Activities . Notwithstanding Section 2.2.3:

(a) Ongoing Clinical Trials .

(i) If Juno is conducting a Clinical Trial(s) with respect to any Licensed Candidate and/or Licensed Product under the Collaboration which has not been completed as of the License Agreement Effective Date, and [***] then Juno will continue to be responsible for the performance of such Clinical Trial(s) (i) [***] (unless otherwise agreed by the Parties) where such Clinical Trial [***], and (ii) [***] (unless otherwise agreed by the Parties) where such Clinical Trial is [***]; and

(ii) If Juno is conducting a Clinical Trial(s) with respect to any Licensed Candidate and/or Licensed Product under the Collaboration that (A) has been [***], or (B) [***], and in each case that has not been completed as of the License Agreement Effective Date, then Juno will continue to be responsible for the performance of such [***], and the expenses associated with such [***] from and after the License Agreement Effective Date.

(b) New Territory-Specific Clinical Trials and Other Studies . Any Clinical Trial(s) and other Development studies that [***] will be conducted [***] by Celgene, [***], subject to Sections 2.2.6(c) and 2.2.7. Any Clinical Trial(s) and other Development studies that [***] will be conducted [***] by Juno, [***], subject to Sections 2.2.6(c) and 2.2.7. Any Clinical Trial(s) and other Development studies [***] shall be conducted by the Party responsible therefor as set forth in the License Development Plan, with [***] the costs of conducting such [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

13


(c) New Clinical Trials and Other Studies . If (i) a Party (the “ Proposing Party ”) wishes (A) to Develop Licensed Products in a country for which it is the Development Lead Party for any Indication in the Field other than the Indication for which such Licensed Products are being Developed pursuant to the License Development Plan, (B) to Develop a dosage form or formulation of Licensed Products in a country for which the Proposing Party is the Development Lead Party other than that being studied in the License Development Plan, or (C) to conduct any other Clinical Trial of a Licensed Products in the Field in a country for which the Proposing Party is the Development Lead Party that is not at such time [***] or is not otherwise set forth in the License Development Plan, including any Clinical Trial that the Proposing Party believes may have utility to support Regulatory Approval on a global basis and any Phase 4 Clinical Trial (each such study not already included in a License Development Plan, an “ Additional Study ”), then the Proposing Party may so notify the other Party and present the proposed design and projected costs of such Additional Study to the JRDC, and the following shall apply:

(1) If the other Party (the “ Non-Proposing Party ”), through its members of the JRDC, agrees to conduct such co-Development and co-fund such Additional Study, the Parties would amend the License Development Plan to include such Additional Study and to provide a budget for the associated costs. The Parties shall negotiate in good faith to agree upon a [***] such Additional Study between the Parties during the [***] period following the date upon which the Non-Proposing Party agrees [***] such Additional Study, provided that if [***] within such time period, each Party shall [***]. If the Parties agree to [***] any Additional Study, [***].

(2) If the Non-Proposing Party does not wish to [***] such proposed Additional Study, but the Non-Proposing Party has no material objection to such Additional Study as set forth in Section 2.2.6(c)(3), the Proposing Party may proceed with such Additional Study and would be solely responsible for the [***]. In such case, the Non-Proposing Party [***], unless and until a [***];

(3) Notwithstanding subsections (1) and (2), if the Non-Proposing Party believes a proposed Additional Study would be likely to [***], such Non-Proposing Party would have the right to refer such matter to the JRDC and, as needed, the JRDC and JSC (if applicable) shall review such Non-Proposing Party’s concerns and consider mechanisms to mitigate or obviate any such concerns. If the JRDC or, if applicable, the JSC does not agree upon whether or not a proposed Additional Study would have [***], then [***]for such Program [***] such matter.

2.2.7 [***] Right . Notwithstanding Section 2.2.6(c)(2) above, [***], the Non-Proposing Party [***] by written notice to the Proposing Party [***] any Additional Study for Licensed Products for which the Non-Proposing Party [***] (the “[***]”) by (a) [***] such Additional Study after the date that the Proposing Party receives such notice from the Non-Proposing Party, to the extent applicable, provided that if [***] after the Non-Proposing Party provides such written notice to the Proposing Party, each Party shall [***], and (b) [***] Non-

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Proposing Party pursuant to subsection (a), [***] the Proposing Party receives such notice from the Non-Proposing Party. Upon any such [***], the Parties shall [***] as set forth in Section 2.2.6(c)(1). If the Non-Proposing Party [***] the Proposing Party the [***] after the Non-Proposing Party notifies the Proposing Party in writing that the Non-Proposing Party [***] pursuant to this Section 2.2.7.

2.2.8 Development Activities in Licensed Territory . Notwithstanding Section 2.2.3 and 2.2.6, (a) Juno retains the right to conduct Development of Licensed Products in the ROW Territory, and (b) Celgene retains the right to conduct Development of Licensed Products outside the ROW Territory, in each case [***] in connection with Juno’s Commercialization of Product outside the ROW Territory, or Celgene’s Commercialization of Product within the ROW Territory, as applicable. Juno retains the right in the ROW Territory, and Celgene retains the right in the North America Territory, to Manufacture and have Manufactured Licensed Candidates and Licensed Products to the extent reasonably required to [***], provided in each case such Manufacturing activities comply with the terms of the Manufacturing Agreement. If either Party plans to undertake such activities, it shall so notify the other Party and [***]. The rights retained by the Parties in this Section 2.2.8 include the right [***] in the ROW Territory (for Juno) or the North America Territory (for Celgene) [***], provided that the Party seeking to [***], and provided further that if the Parties are [***] will be considered a [***].

2.2.9 Meetings and Reports . During the License Term:

(a) Committees . The JSC, the JMC, the Patent Committee and the JRDC shall remain established as set forth in Article 4 of the Master Collaboration Agreement, and shall be responsible for performing the functions set forth in Article 4 of the Master Collaboration Agreement. Notwithstanding the foregoing, with respect to matters that are [***], the JSC and the JRDC shall serve solely as a forum for exchanging information and facilitating discussions. The Development Lead Party shall have the final decision making right with respect to all activities relating to the Licensed Program that [***]. For any matters arising in relation to the Development and Commercialization of Licensed Candidates, Licensed Products or Licensed Diagnostic Products that [***], the decision shall be referred to the Executive Officers for resolution and shall thereafter be subject to Section 4.2.5 of the Master Collaboration Agreement and this Section 2.2.9(a).

(b) Status Reports . Each Party shall provide a reasonably detailed written progress report to the JRDC, at least [***], on the status of its activities and efforts with respect to the Licensed Program, including the status of any Licensed Candidate being Developed and/or Commercialized under such Licensed Program, including (to the extent not covered in the License Development Plan): (A) the design, status and results of any Clinical Trials and other studies for Licensed Products; and (B) any key development or regulatory events, and any Regulatory Approvals achieved, for Licensed Products. Such report should be provided no later than [***] before the next scheduled meeting of the JRDC, in order to provide the JRDC the opportunity to review such report prior to such meeting.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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2.3 Regulatory.

2.3.1 Transfer of Regulatory Materials . Juno shall transfer, promptly after the License Agreement Effective Date (but subject to Section 2.3.2), to Celgene any and all Regulatory Materials (including any foreign counterparts of the IND and BLA) for all Licensed Candidates, Licensed Products and Licensed Diagnostic Products in or for the ROW Territory, and thereafter Celgene (or its designee) shall file and hold title to all Regulatory Materials and Regulatory Approvals and supplements thereto relating to Licensed Candidates, Licensed Products and Licensed Diagnostic Products in and for the ROW Territory.

2.3.2 Responsibility . As of and after the date upon which the transfer is effected pursuant to Section 2.3.1, Celgene will lead and have sole control of all efforts with Regulatory Authorities regarding the Development, Manufacture and Commercialization of Licensed Candidates, Licensed Products and Licensed Diagnostic Products in the Field in the ROW Territory, including taking full responsibility for preparing and filing the relevant Regulatory Materials and seeking Regulatory Approval. During the License Term, and in addition to Celgene’s obligations pursuant to Sections 2.2.9(b) and 2.3.3, Celgene shall keep Juno reasonably informed, through updates at each meeting of the JRDC, of material regulatory activities and events that occur with respect to Licensed Candidates, Licensed Products and Licensed Diagnostic Products in the ROW Territory. Notwithstanding the foregoing, in the event Juno continues to be responsible for the performance of a Clinical Trial pursuant to and in accordance with Section 2.2.6(a), Juno will retain ownership of any Regulatory Materials and Regulatory Approvals (including any equivalent of the IND for any country in the ROW Territory) for Licensed Candidates and Licensed Products until completion of such Clinical Trial. In the event of failure to assign such Regulatory Materials and Regulatory Approvals to Celgene as required by Section 2.3.1 and this Section 2.3.2, Juno hereby consents and grants to Celgene the right to access and reference (without any further action required on the part of Juno, whose authorization to file this consent with any Regulatory Authority is hereby granted) any such Regulatory Materials and Regulatory Approvals.

2.3.3 Rights to Use Licensed Product Data .

(a) Each Party, as the Development Lead Party in a given country for Development of Licensed Candidates, Licensed Products and Licensed Diagnostic Products in such country, shall keep accurate records of all Licensed Product Data generated as a result of all activity by or on behalf of such Development Lead Party in performing Development and Commercialization in relation to Licensed Candidates, Licensed Products and Licensed Diagnostic Products, including any data generated pursuant to the Party’s activities under Section 2.2.6(c)(1). Except as provided in Section 2.2.6(c)(2), each Development Lead Party shall provide the other Party with copies of all such Licensed Product Data Controlled by the Development Lead Party during the term of this License Agreement that is [***] the Development and Commercialization of Licensed Candidates, Licensed Products or Licensed Diagnostic Products promptly following the generation of such Licensed Product Data. Celgene Licensed Product Data (other than that to which Juno does not have rights pursuant to Section

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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2.2.6(c)(2)) shall be included in the license grant to Juno pursuant to Section 6.1.2, and Juno Licensed Product Data [***] shall be included in the Juno Know-How and licensed to Celgene pursuant to Section 6.1.1.

(b) Notwithstanding anything to the contrary in this License Agreement, each Development Lead Party shall promptly provide to the other Party, [***], copies of and rights of reference to and use of all Licensed Product Data that is Controlled by the Development Lead Party, and that are relevant to or necessary to address issues relating to: (i) the safety of Licensed Candidates or Licensed Products within or outside the ROW Territory, including data that is related to adverse effects experienced with Licensed Candidates or Licensed Products, or (ii) CMC Activities relating to Licensed Candidates or Licensed Products, and in each of (i) and (ii), that are required to be reported or made available to Regulatory Authorities within or outside the ROW Territory, when and as such data become available (collectively, “ Safety and CMC Data ”). Each Party shall use the Safety and CMC Data provided to it pursuant to this Section 2.3.3(b) solely to Develop and Commercialize Licensed Products in the Field in the ROW Territory (in the case of Celgene), and in the Field outside the ROW Territory (in the case of Juno).

2.3.4 Communication with Regulatory Authorities .

(a) Subject to Sections 2.3.5 and 2.3.6, Celgene shall be responsible for handling all complaints and communications (including with Regulatory Authorities) relating to Licensed Candidates, Licensed Products or Licensed Diagnostic Products within the ROW Territory. Celgene shall promptly notify Juno (which may be through the JRDC or the JSC) of any material oral or written communications to or from Regulatory Authorities on matters related to the Licensed Candidates, Licensed Products or Licensed Diagnostic Products, or which may reasonably be deemed to impact the Development, Manufacture, marketing, Regulatory Approval or Commercialization of Licensed Candidates, Licensed Products or Licensed Diagnostic Products outside the ROW Territory, and shall provide Juno with copies of any such material written communications within [***], or earlier as specified in the Pharmacovigilance Agreement, of receipt or delivery of such communication, as the case may be, or such earlier date as required by applicable Laws, the FDA, the EMA or other relevant Regulatory Authority. In addition to the foregoing, Celgene shall give Juno reasonable opportunity to review and comment on any proposed response to any such oral or written communications to or from Regulatory Authorities prior to submitting any response thereto, and provide Juno with a copy of the final response as specified herein.

(b) Subject to Sections 2.3.5 and 2.3.6, Juno shall be responsible for handling all complaints and communications (including with Regulatory Authorities) relating to the Licensed Candidates, Licensed Products or Licensed Diagnostic Products outside the ROW Territory. Juno shall promptly notify Celgene (which may be through the JRDC or the JSC) of any material oral or written communications to or from Regulatory Authorities on matters related to the Licensed Products, or which may reasonably be deemed to impact Development, Manufacture, marketing, Regulatory Approval or Commercialization of Licensed Candidates,

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Licensed Products or Licensed Diagnostic Products, within the ROW Territory, and shall provide Celgene with copies of any such material written communications within [***], or earlier as specified in the Pharmacovigilance Agreement, of receipt or delivery of such communication, as the case may be, or such earlier date as required by applicable Laws, the FDA, the EMA or other relevant Regulatory Authority. In addition to the foregoing, Juno shall give Celgene reasonable opportunity to review and comment on any proposed response to any such oral or written communications to or from Regulatory Authorities prior to submitting any response thereto, and provide Celgene with a copy of the final response as specified herein.

2.3.5 Pharmacovigilance .

(a) The Parties will enter into a pharmacovigilance agreement within [***] after the License Agreement Effective Date that shall govern their obligations with respect to the exchange, handling and reporting of adverse events, other safety information and Licensed Product complaints during Development and Commercialization of the Licensed Candidates and Licensed Products in each Party’s territory (the “ Pharmacovigilance Agreement ”). In general, the Pharmacovigilance Agreement will provide that (i) [***] will be responsible for such obligations within the ROW Territory, and [***] will be responsible for such obligations outside the ROW Territory. [***] will deploy and administer any safety monitoring activity implemented for the Licensed Candidates and Licensed Products in the ROW Territory, and be responsible for all pharmacovigilance activities for the Licensed Candidates and Licensed Products in the ROW Territory, (ii) [***] will deploy and administer any safety monitoring activity implemented for the Licensed Candidates and Licensed Products outside the ROW Territory, and be responsible for all pharmacovigilance activities for the Licensed Candidates and Licensed Product outside the ROW Territory, and (iii) [***] will establish and maintain a global safety database for Licensed Candidates and Licensed Products that will contain all information and data arising from the Parties’ activities with respect to safety matters that is required to be contributed by each Party pursuant to the Pharmacovigilance Agreement, including information and data arising out of any safety monitoring activities.

(b) The Parties shall discuss, through the JRDC, and agree upon standard provisions reasonably acceptable to both Parties regarding: (i) [***] in connection with Licensed Candidates, Licensed Products or Licensed Diagnostic Products [***]; and (ii) [***] which may result in [***] each Party with respect thereto.

(c) Each Party shall inform the other Party during the License Term, in accordance with the Pharmacovigilance Agreement, of the side effect profiles for Licensed Candidates and Licensed Products, including pregnancy and suspected pregnancy, damages, toxicity or sensitivity reactions associated with the use of any Licensed Candidate or Licensed Product, regardless of whether these effects are attributable to such Licensed Candidate or Licensed Product. Each Party shall have the right to take [***], including the right to [***] of such Licensed Candidate or Licensed Product, if there are [***], as determined in accordance with the Pharmacovigilance Agreement, [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(d) In accordance with the procedures established by the Parties under the Pharmacovigilance Agreement, each Party shall cooperate with the other Party and share information concerning the pharmaceutical safety of each Licensed Candidate and Licensed Product. Each Party shall: (i) promptly advise the other Party of [***] of such Licensed Candidate or Licensed Product and any actions taken in response to such information; (ii) promptly advise the other Party of [***] of such Licensed Candidate or Licensed Product [***], as far as this concerns [***]; and (iii) timely provide the other Party with [***] such Licensed Candidate or Licensed Product of which the [***], as far as this relates to [***] to perform their obligations or exercise their rights under this License Agreement. Treatment of safety information, standard operating procedures and training, as well as a statement of respective regulatory obligations shall be agreed in the Pharmacovigilance Agreement.

2.3.6 Right of Reference .

(a) Except as provided in Section 2.2.6(c)(2), Celgene and its Affiliates and Sublicensees shall have access to all data contained or referenced in any Regulatory Materials (including any Regulatory Approvals), including any Juno Licensed Product Data, Controlled by Juno that are [***] Development, Manufacture or Commercialization (as set forth in this License Agreement) of Licensed Candidates and Licensed Products, and related Licensed Diagnostic Products in the ROW Territory; and

(b) Except as provided in Section 2.2.6(c)(2), Juno and its Affiliates and Sublicensees shall have access to all data contained or referenced in any Regulatory Materials (including any Regulatory Approvals), including any Celgene Licensed Product Data, Controlled by Celgene that are [***] Development, Manufacture or Commercialization (as set forth in this License Agreement) of Licensed Candidates and Licensed Products, and related Licensed Diagnostic Products outside the ROW Territory.

2.3.7 Compliance .

(a) Obligations . Each of Celgene and Juno shall reasonably cooperate with the other Party in its efforts to ensure that all government reporting, including price and gift reporting, sales, marketing and promotional practices in respect of each Licensed Product both within and outside the ROW Territory meet the standards required by applicable Laws.

(b) Information . Each of Celgene and Juno shall reasonably cooperate with the other Party to provide the other Party access to any and all information, data and reports required by the other in order to enable the other Party to comply with applicable Laws, including reporting requirements, or the equivalent thereof in the Licensed Territory, in a timely and appropriate manner. Each Party shall ensure that any such reporting is true, complete and correct in all respects; provided however that neither Party shall be held responsible for submitting erroneous reports to the extent such deficiencies result from information provided by the other Party which itself was not true, complete and correct.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(c) Cooperation . Celgene and Juno shall confer with each other on a regular basis through the JCC to discuss and compare their respective procedures and methodologies relating to each Party’s compliance with applicable Laws or fulfilment of any other obligation in this Section 2.3. In the event that the Parties have different understandings or interpretations of this Section 2.3 or of the applicability of, or standards required by any applicable Laws, then the Parties shall confer and seek to reach common agreement on such matters, and in the absence of such agreement, the escalation and decision making procedures set forth in Section 4.2.5 of the Master Collaboration Agreement shall apply.

2.4 Manufacturing and Supply . The provisions of Section 2.10 of the Master Collaboration Agreement and the Manufacturing Agreement shall apply to the Parties’ establishment and operation of manufacturing facilities for [***] Products and [***] Products in the Territory.

2.5 Records; Reports; Results . Each Party shall maintain or cause to be maintained complete, current and accurate records of all Development activities conducted by it (or its Affiliates and subcontractors) hereunder, and all data, results and analyses (including site records and master files) and other information resulting from such activities. Such records shall (i) fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes, and (ii) record only such activities and shall not include or be commingled with records of activities that do not relate to the Development and Commercialization of Licensed Candidates, Licensed Products and/or Licensed Diagnostic Products, or activities carried out pursuant to this License Agreement. Each Party shall document all non-clinical studies and Clinical Trials in formal written study records according to applicable Laws, including national and international guidelines such as ICH, GCP, GLP and GMP. All such records shall be retained by the relevant Party for at least [***] after the termination of this License Agreement or for such longer period as may be required by applicable Law. Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times, as reasonably requested by either Party.

2.6 Materials Transfer and Licenses.

2.6.1 Materials Transfer . During the License Term, either Party (the “ License Transferring Party ”) shall transfer, if [***] (the “ License Materials Receiving Party ”) and subject to any Third Party obligations, certain [***] materials, which may include [***] (the “ License Materials ”) for use by the License Materials Receiving Party in furtherance of its rights and the conduct of its obligations under this License Agreement (the “ License Purpose ”). All transfers of such License Materials by the License Transferring Party to the License Materials Receiving Party shall be documented in a material transfer agreement substantially in the form of Exhibit E , which sets forth the type and name of the License Material transferred, the amount of the License Material transferred, the date of the transfer of such License Material and the License Purpose (each, a “ License Material Transfer Agreement ”). Such License Materials will be provided to the License Materials Receiving Party within a reasonable time

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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period after the Parties execute the relevant License Material Transfer Agreement, not to exceed [***]. Neither Party will unreasonably withhold its consent to any request made by the other Party pursuant to this Section 2.6.1, except that subject to the last sentence of this Section 2.6.1, Juno shall have no obligation to transfer to Celgene [***] unless it otherwise agrees in writing, [***] and Celgene shall have no obligation to transfer to Juno [***] unless it otherwise agrees in writing, [***]. The Parties agree that the exchanged License Materials shall be used in compliance with applicable Law and the terms and conditions of this License Agreement, and shall not be reverse engineered or chemically analysed, except if required by the License Purpose or otherwise agreed to by the Parties in writing.

2.6.2 License by License Transferring Party . At the time the License Transferring Party provides the License Materials to the License Materials Receiving Party as provided herein and to the extent not separately licensed under this License Agreement, the License Transferring Party hereby grants, and shall cause (within [***] after the execution of any License Material Transfer Agreement) its Affiliates to grant, to the License Materials Receiving Party a non-exclusive license under the Patents and Know-How Controlled by it to use such License Materials solely for the License Purpose, and such license, upon termination of this License Agreement (subject to Article 9), completion of the License Purpose, or discontinuation of the use of such License Materials (whichever occurs first), shall automatically terminate. Except as otherwise provided under this License Agreement, all such License Materials delivered by the License Transferring Party, shall only be used by the License Materials Receiving Party in furtherance of the License Purpose, and shall be returned to the License Transferring Party or destroyed, in the License Transferring Party’s sole discretion, upon the termination of this License Agreement (subject to Article 9) or upon the discontinuation of the use of such License Materials (whichever occurs first), unless such Party has the right to continue to use such materials under the Master Collaboration Agreement, a Development & Commercialization Agreement for purposes permitted thereunder, including pursuant to intellectual property or material transfer agreements executed in connection therewith. The License Materials Receiving Party shall not [***].

2.6.3 NO WARRANTIES . THE LICENSE MATERIALS SUPPLIED BY THE TRANSFERRING PARTY UNDER THIS SECTION 2.6 ARE SUPPLIED “AS IS” AND, EXCEPT AS OTHERWISE SET FORTH IN THIS LICENSE AGREEMENT, THE TRANSFERRING PARTY MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE LICENSE MATERIALS OR USE THEREOF DO NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS OF A THIRD PARTY. The License Materials Receiving Party assumes all liability for damages that may arise from its use, storage or disposal of the License Materials. Except as otherwise set forth in this License Agreement, the Transferring Party shall not be liable to the License Materials Receiving Party for any loss, claim or demand made by the License Materials Receiving Party, or made against the License Materials Receiving Party by any Third Party, due to or arising from the use of the License Materials, except to the extent such loss, claim or demand is caused by the wilful misconduct of the Transferring Party.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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2.7 No Representation . Subject to Section 2.2.1, neither Party makes any representation, warranty or guarantee that the Licensed Program will be successful, or that any other particular results will be achieved with respect to the Licensed Program, Licensed Target, any Licensed Candidate, any Licensed Product or any Licensed Diagnostic Product hereunder.

2.8 Covenant During License Term . Commencing on the License Agreement Effective Date until expiration of each Party’s exclusivity obligations pursuant to Article 4 with respect to the Licensed Program, neither Party nor its Affiliates will, other than to an Affiliate of such Party who agrees in writing to be bound by the terms and conditions of this License Agreement, (a) assign, transfer, convey, encumber (including any liens or charges, but excluding any licenses, which are the subject of subsection (b), below) or dispose of, or enter into any agreement with any Third Party to assign, transfer, convey, encumber (including any liens or charges, but excluding any licenses, which are the subject to subsection (b), below) or dispose of, any assets [***] (the “ Licensed Program Assets ”), except to the extent such assignment, transfer, conveyance, encumbrance or disposition would not conflict with or adversely affect in any respect any of the rights granted to the other Party hereunder, (b) license or grant to any Third Party, or agree to license or grant to any Third Party, any rights to any Licensed Program Assets if such license or grant would conflict with or adversely affect in any respect any of the rights granted to the other Party hereunder, or (c) disclose any Confidential Information relating to the Licensed Program Assets to any Third Party if such disclosure would impair or conflict in any respect with any of the rights granted to the other Party hereunder. Notwithstanding this Section 2.8, either Party and/or its Affiliates shall have the right to assign, transfer, convey or dispose of any assets specifically related to this Licensed Program to [***]; provided that (i) [***] this License Agreement, and (ii) such [***] this License Agreement.

2.9 Additional [***] Programs. If, during the term of this License Agreement, Juno offers to the Collaboration any [***] Program that includes [***], and Celgene exercises its Option pursuant to Section 3.1.5 of the Master Collaboration Agreement with respect to such [***] Program, then (a) such [***] Program shall [***], (b) Celgene shall make the Designation Payment for such [***] Program in accordance with Paragraph 1(b) of Exhibit C-3 , and (c) within [***] after Celgene exercises such Option, the Parties shall amend Exhibit B to include the applicable [***] the Licensed Program, [***] as Licensed Candidates, under this License Agreement.

ARTICLE 3

COMMERCIALIZATION; CELGENE RIGHT TO CO-PROMOTE

3.1 Commercialization. Subject to the terms and conditions of this License Agreement, (a) Celgene will have sole responsibility for Commercialization of Licensed Products and Licensed Diagnostic Products in the ROW Territory, subject to Juno’s rights under Section 3.3.1, and except as otherwise set forth in this License Agreement, will have [***], and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(b) Juno will have sole responsibility for Commercialization of Licensed Products and Licensed Diagnostic Products outside of the ROW Territory subject to Celgene’s rights under Sections 3.2 and 3.3.2, and except as otherwise set forth in this License Agreement, will have [***]. For clarity, the Commercialization Lead Party shall retain all right and authority to Commercialize Licensed Products and Licensed Diagnostic Products in the countries for which it serves as the Commercialization Lead Party, subject to Section 3.3. The non-Commercialization Lead Party (itself or by or through any others, including any Affiliates or Sublicensees will not take any action regarding the Commercialization of Licensed Products or Licensed Diagnostic Products in the countries for which it is not the Commercialization Lead Party unless mutually agreed in writing following a Party’s exercise of its right to opt-in to certain Commercialization Activities pursuant to Section 3.3, or described in the License Commercialization Plan, or otherwise approved by the JCC.

3.2 Celgene Right to Co-Promote; Conversion to Juno Lead Co-Co Agreement.

3.2.1 Right to Co-Promote . In accordance with Section 3.1.4 of the Master Collaboration Agreement, Celgene has the right to designate up to two (2) Juno Programs or [***] Programs [***] as Celgene Co-Promote Programs, provided that each such Juno Program or [***] Program [***], unless [***]), in which case Celgene may designate one (1) additional Juno Program (other than the CD19 Program or the CD22 Program) or [***] Program [***] as a Celgene Co-Promote Program, provided that such Juno Program or [***] Program [***], for a total of three (3) Programs that are Celgene Co-Promote Programs.

3.2.2 Exercise of the Celgene Co-Promote Right . At any time prior to the [***] the Licensed Program, if Celgene wishes to designate the Licensed Program as a Celgene Co-Promote Program, and Celgene has not already exercised such Celgene Co-Promote Right with respect to a total of two (2) Programs that were Juno Programs or [***] Programs (or, [***]), a total of three (3) Juno Programs), then Celgene may exercise the Celgene Co-Promote Right with respect to the Licensed Program by written notice to Juno as set forth in Section 3.1.4 of the Master Collaboration Agreement. Within [***] following Juno’s receipt of such written notification from Celgene, the Parties shall terminate this License Agreement and simultaneously enter into a Juno Lead Co-Co Agreement with respect to the Licensed Program, and the following provisions shall apply as of the date that such Celgene Co-Promote Right is exercised:

(a) the Program that was the subject matter of this License Agreement shall no longer be deemed a Licensed Program hereunder, but shall be deemed “Juno Co-Co Program” under the applicable Juno Lead Co-Co Agreement;

(b) the Target that was the subject matter of this License Agreement shall no longer be deemed the Licensed Target hereunder, but shall be deemed the “Juno Program Co-Co Target” under the applicable Juno Lead Co-Co Agreement; and

(c) the Development Candidates and other compounds and products that were the subject matter of this License Agreement shall no longer be deemed the Licensed Candidates, Licensed Products or Licensed Diagnostic Products, as applicable, but shall be deemed the “Juno Program Co-Co Candidates”, “Juno Program Co-Co Products” or “Juno Program Co-Co Diagnostic Products” under the applicable Juno Lead Co-Co Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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3.3 Opt-In Right for Certain Commercialization Activities under License Agreement.

3.3.1 Juno Right to Opt-In . On a Licensed Product-by-Licensed Product basis Juno shall have the right, exercisable upon written notice to Celgene at any time prior to, or within [***] for such Licensed Product, to elect to exercise a Commercialization Opt-In Right and provide [***] of the Commercialization Activities for such Licensed Product in the Major EU Market Countries. [***]. If Juno exercises the Commercialization Opt-In Right, Celgene shall, after conferring with Juno, update the License Commercialization Plan for such countries to include the rights and obligations with respect thereto, which shall in any event be consistent with the then-existing License Commercialization Plan for such countries prepared by Celgene pursuant to Section 3.4.2, and which shall include the terms set forth in the Commercialization Opt-In Terms attached hereto as Exhibit F . Juno [***].

3.3.2 Celgene Right to Opt-In . If this License Agreement has been entered into with respect to the [***] Program, then if Juno [***], on a Licensed Product by Licensed Product basis, Celgene shall have the right to exercise a Commercialization Opt-In Right upon written notice to Juno within [***] such Licensed Product [***], to elect to participate in [***] of the Commercialization Activities for such Licensed Product for [***] in the [***]. If Celgene exercises a Commercialization Opt-In Right [***], [***]. Following Celgene’s exercise of the Commercialization Opt-In Right for [***], Juno shall, after conferring with Celgene, update the License Commercialization Plan for such countries to include the rights and obligations with respect thereto, which shall in any event be consistent with the then-existing License Commercialization Plan for such countries prepared pursuant to Section 3.4.2, and shall include the terms set forth in the Commercialization Opt-In Terms attached hereto as Exhibit F . If Celgene exercises a Commercialization Opt-In Right under this Section 3.3.2 to perform Commercialization Activities for Licensed Products in [***], Celgene [***]. For clarity, Celgene’s rights under this Section 3.3.2 shall only apply to Licensed Products that are [***] a Licensed Target that is [***], and for such Licensed Products, such rights shall apply only for [***].

3.3.3 Costs of Participation in Commercialization . Following the exercise by a Party of the Commercialization Opt-In Right pursuant to Sections 3.3.1 or 3.3.2, the Commercialization Lead Party in a given territory (for Juno, in the North America Territory and for Celgene, in the ROW Territory) shall continue to [***]. The Commercialization Lead Party [***] (a) [***] and (b) [***], in each case of (a) and (b), [***] pursuant to Section 3.3.1 or 3.3.2, as applicable, in relation to the Commercialization of Licensed Products following the exercise of the Commercialization Opt-In Right.

3.4 Additional Terms of Commercialization.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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3.4.1 Role of the JCC . The JCC will coordinate the Parties’ efforts with respect to the Commercialization of Licensed Products in the North America Territory and in the ROW Territory. Specifically, the JCC will oversee the development of [***] for Licensed Products, coordinate training of sales representatives and others involved in Commercialization pursuant to Sections 3.3.1 and 3.3.2 and Exhibit F , and coordinate commercial supply of Licensed Products pursuant to this License Agreement.

3.4.2 License Commercialization Plan .

(a) The Commercialization Lead Party for the relevant country(ies) as to which a Commercialization Opt-In Right pursuant to Section 3.3.1 or 3.3.2 has been exercised will prepare an initial License Commercialization Plan for such Licensed Product in such relevant country(ies) covering the first [***] after First License Sale of such Licensed Product in such relevant country(ies). The JCC will review and comment on each Commercialization Lead Party’s plan for Commercialization of Licensed Products the countries in which it is the Commercialization Lead Party. Thereafter, the Commercialization Lead Party ([***]) will update the relevant portion of the License Commercialization Plan ([***], and the JCC will review and comment on any such update or other amendment to such License Commercialization Plan. The Commercialization Lead Party will also update the License Commercialization Plan as provided in Section 3.3. Either Party may request at any time that the JCC consider other updates to such License Commercialization Plan. The JCC will set the required form and contents of any License Commercialization Plan. The License Commercialization Plan will specify, as applicable, among other things, for each applicable country and Licensed Product, the [***] Licensed Products. Furthermore, after a Party’s opt-in pursuant to Section 3.3, the License Commercialization Plan will also specify (a) [***], (b) [***], (c) [***], (d) [***], (e) [***], (f) [***], and (g) [***].

3.4.3 Branding . If and at such time as the JCC deems appropriate, the JCC shall discuss in good faith any branding and/or co-branding of the Licensed Products to be used in connection with the Commercialization of Licensed Products both in the North America Territory and in the ROW Territory and the Parties will enter into appropriate trademark licensing agreements to achieve the foregoing. For the avoidance of doubt, nothing in this License Agreement shall be construed to grant either Party any rights in or to any of the other Party’s trademarks, trade names, logos, or other marks, including use thereof, absent a separate trademark licensing agreement entered into in accordance with this Section 3.4.3.

3.4.4 Commercialization Reports . At least [***] during the License Term, the Commercialization Lead Party shall provide to the other Party, through the JCC, with a [***] on the status of its Commercialization Activities with respect to Licensed Products and related Licensed Diagnostic Products (a “ Commercialization Report ”) during the applicable [***], and the Commercialization Lead Party’s plans with respect to Commercialization of Licensed Products and Licensed Diagnostic Products during [***] period. Such Commercialization Report shall also describe [***]) with respect to such Licensed Products and Licensed Diagnostic Products, [***]. At least [***] prior to the anticipated First License Sale of a Licensed Product under this License Agreement, the JCC shall discuss and agree upon the form and content for such Commercialization Report.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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ARTICLE 4

EXCLUSIVITY

4.1 Exclusivity . Article 5 of the Master Collaboration Agreement shall apply to the Parties’ activities under this License Agreement, in each case to the extent applicable to the License Program that is the subject of this License Agreement, for the time periods, and to the extent expressly set forth therein.

ARTICLE 5

FINANCIAL TERMS

5.1 CD19 Program. In the event the Licensed Program is the CD19 Program, then the financial terms set forth on Exhibit C-1 shall apply.

5.2 CD22 Program. In the event the Licensed Program is the CD22 Program, then the financial terms set forth on Exhibit C-2 shall apply.

5.3 Other Juno Programs and [***] Programs . In the event the Licensed Program is an Other Juno Program or an [***] Program, then the financial terms set forth on Exhibit C-3 shall apply.

5.4 Royalties Payment Terms.

5.4.1 Royalty Reduction for Comparable License Third Party Product Competition .

(a) For Licensed Products, during the Licensed Product Royalty Term for such Licensed Product, on a Licensed Product-by-Licensed Product, country-by-country and Calendar Year-by-Calendar Year basis, if during such Calendar Year one or more Comparable License Third Party Products for such Licensed Product are sold in such country,

(i) the License Annual Unit Sales during such Calendar Year in such country are [***]; or

(ii) the License Annual Unit Sales during such Calendar Year in such country are [***];

then the royalties payable with respect to License Net Sales of such Licensed Product pursuant to Paragraph 2 of Exhibit C-1 , C-2 or C-3 , as applicable, in such country during such Calendar Year shall be reduced [***] if subsection (i) applies, and [***] if subsection (ii) applies.

(b) For Licensed Products that are described in Section 1.15(a), until the latest of (i) the [***], (ii) the [***], and (iii) the [***] anniversary of the date of First License Sale of

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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such Licensed Product in such country, [***] royalties due with respect to such Licensed Products pursuant to this Section 5.4.1(b), but for clarity, the [***] of this Section 5.4.1(b). After the [***] for such Licensed Products, royalties shall still be payable with respect to License Net Sales of such Licensed Products, on a Licensed Product-by-Licensed Product, country-by-country and Calendar Year-by-Calendar Year basis, provided that if during such Calendar Year:

[***]

(i) the License Annual Unit Sales of such Licensed Product during such Calendar Year in such country are [***];

(ii) the License Annual Unit Sales of such Licensed Product during such Calendar Year in such country are [***]; or

(iii) the License Annual Unit Sales of such Licensed Product during such Calendar Year in such country are [***],

then the royalties payable with respect to License Net Sales of such Licensed Product pursuant to Paragraph 2 of Exhibit C-1 , C-2 or C-3 , as applicable, in such country during such Calendar Year shall be reduced by [***] if subsection (b)(i) applies, [***] if subsection (b)(ii) applies and [***]. For such Licensed Products, once subsection (b)(iii) applies, no further royalties shall be payable with respect to License Net Sales of such Licensed Products.

For the purposes of this Section 5.4.1, sales of units of such Licensed Product for calculating License Annual Unit Sales shall be those reported by [***], or if such data are not available, [***]. Notwithstanding anything to the contrary, [***].

5.4.2 Royalty Reduction for Third Party Payments . Subject to Section 5.4.3, the royalty rate set forth in Paragraphs 2(a) and 3 of Exhibit C-1 , C-2 or C-3 , as applicable, shall be reduced, on a Licensed Product-by-Licensed Product and Licensed Diagnostic Product-by-Licensed Diagnostic Product, country-by-country and Calendar Quarter-by-Calendar Quarter basis, by (a) an amount equal to [***] in such Calendar Quarter [***] with respect to sales of such Licensed Product or Licensed Diagnostic Product [***] in such Calendar Quarter; provided that in no event shall the royalty payable by Celgene to Juno pursuant to this Section 5.4.2 and Exhibit C be [***] sales of such Licensed Product or Licensed Diagnostic Product in such Calendar Quarter [***], provided that in no event shall the royalty payable by Celgene to Juno pursuant to this Section 5.4.2 and Exhibit C be [***]. Celgene may [***] as described in this Section 5.4.2 [***].

5.4.3 Cumulative Effect of Royalty Reductions . In no event shall the royalty reductions described in Section 5.4.2 reduce the effective royalty rate payable by Celgene, its Affiliates or Sublicensees with respect to License Net Sales (a) arising from the [***], to less than [***] and (b) arising from [***], to less than [***] (the “ Floor Royalty ”). For clarity, if [***], and if [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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5.4.4 Payment of Royalties . Celgene shall: (a) within [***] following the end of each Calendar Quarter in which a royalty payment accrues, provide to Juno a report for each country in the Territory in which sales of Licensed Product or related Licensed Diagnostic Product occurred in the Calendar Quarter covered by such statement, specifying: the gross sales (if available) and License Net Sales in each country’s currency; the applicable royalty rate under this License Agreement; the royalties payable in each country’s currency, including an accounting of deductions taken in the calculation of License Net Sales in accordance with Celgene’s Accounting Principles; the applicable exchange rate to convert from each country’s currency to U.S. Dollars under Section 5.5.1; and the royalties payable in U.S. Dollars, and (b) make the royalty payments owed to Juno hereunder in accordance with such royalty report in arrears, within [***] from the end of each Calendar Quarter in which such payment accrues.

5.4.5 Discounted Sales . It is possible that a Licensed Product could be included as part of a package of products offered to customers by Celgene or its Affiliates or Sublicensees, and that discounts on packages including a Licensed Product (a “ Package ”) may be offered in the Territory. None of Celgene, its Affiliates or Sublicensees shall discount the price of a Licensed Product sold as part of a Package [***].

5.5 Additional Payment Terms.

5.5.1 Accounting . All payments hereunder shall be made in the United States in U.S. Dollars by wire transfer to a bank in the U.S. designated in writing by Juno. Conversion of sales recorded in local currencies to Dollars shall be performed in a manner consistent with [***].

5.5.2 Late Payments . Any payments or portions thereof due hereunder that are not paid on the date such payments are due under this License Agreement shall bear interest at an annual rate equal to the lesser of: (a) [***], or any successor thereto, at 12:01 a.m. on the first day of each Calendar Quarter in which such payments are overdue or (b) the maximum rate permitted by applicable Law; in each case calculated on the number of days such payment is delinquent, compounded monthly.

5.5.3 Tax Withholding .

(a) Tax Withholding . Each Party shall be entitled to deduct and withhold from any amounts payable under this License Agreement such taxes as are required to be deducted or withheld therefrom under any provision of applicable Law. The Party that is required to make such withholding (the “ Paying Party ”) will: (i) deduct those taxes from such payment, (ii) timely remit the taxes to the proper taxing authority, and (iii) send evidence of the obligation together with proof of tax payment to the recipient Party (the “ Payee Party ”) on a timely basis following that tax payment; provided, however, that before making any such deduction or withholding, the Paying Party shall give the Payee Party notice of the intention to make such deduction or withholding (such notice, which shall include the authority, basis and method of calculation for the proposed deduction or withholding, shall be given at least a reasonable period of time before such deduction or withholding is required, in order for such

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Payee Party to obtain reduction of or relief from such deduction or withholding). Each Party agrees to cooperate with the other Parties in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect to ensure that any amounts required to be withheld pursuant to this Section 5.5.3(a) are reduced in amount to the fullest extent permitted by applicable Laws. In addition, the Parties shall cooperate in accordance with applicable Laws to [***] in connection with this License Agreement, as applicable.

(b) Tax [***] . Notwithstanding the foregoing, and subject to Section 6.7.2 of the Master Collaboration Agreement, if (i) any Party [***], (ii) as a result of [***], such Party (or its assignee) [***], and (iii) [***] (A) [***] or (B) [***]. To the extent [***]. The foregoing sentence [***]. Furthermore, [***]. Solely for purposes of this Section 5.5.3(b), (1) [***] and (2) [***].

(c) Tax Documentation . Each Party has provided a properly completed and duly executed IRS Form W-9 or applicable Form W-8 to the other Parties. Each Party and any other recipient of payments under this License Agreement shall provide to the other Party, at the time or times reasonably requested by such other Parties or as required by applicable Law, such properly completed and duly executed documentation (for example, IRS Forms W-8 or W-9) as will permit payments made under this License Agreement to be made without, or at a reduced rate of, withholding for taxes.

5.6 Records Retention by Celgene; Review by Juno.

5.6.1 Royalty Records . With respect to payments to be made under Sections 5.1 through 5.4, inclusive, Celgene agrees to keep, and to require its Affiliates and Sublicensees to keep, for at least [***] from the end of [***], complete and accurate records of transfer and sales by Celgene or its Affiliates or Sublicensees, as the case may be, of each Licensed Product and related Licensed Diagnostic Product, in sufficient detail to allow the accuracy of the payments made thereunder to be confirmed. Notwithstanding the foregoing, if a Juno Upstream Agreement requires such records to be maintained for longer time periods or imposes additional requirements on licensees or sublicensees with respect to the relevant License Net Sales, Juno will disclose to Celgene in advance of the first License Net Sales the applicable requirements, and the Parties will cooperate in good faith to agree upon a manner for complying with such Juno Upstream Agreement.

5.6.2 Review . Subject to the other terms of this Section 5.6.2, at the request of Juno, which shall not be made more frequently than [***] during the License Term, upon at least [***] prior written notice from Juno, and at the expense of Juno, Celgene shall permit an independent, nationally-recognized certified public accountant selected by Juno and reasonably acceptable to Celgene to inspect (during regular business hours) the relevant records required to be maintained by Celgene under Section 5.6.1. In every case the accountant must have previously entered into a confidentiality agreement with both Parties substantially similar to the provisions of Article 8 of the Master Collaboration Agreement and limiting the disclosure and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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use of such information by such accountant to authorized representatives of the Parties and the purposes germane to Section 5.6.1. Results of any such review shall be binding on both Parties absent manifest error. Juno shall treat the results of any such accountant’s review of Celgene’s records as Confidential Information of Celgene subject to the terms of Article 8 of the Master Collaboration Agreement. If any review reveals a deficiency or overpayment in the calculation and/or payment of royalties by Celgene, then (a) Celgene or Juno shall promptly pay the other Party the amount remaining to be paid, and (b) if such underpayment is by [***] or more in any Calendar Year, Celgene shall, within [***] of invoice therefor, pay the reasonable out-of-pocket costs and expenses incurred by Juno in connection with the review.

ARTICLE 6

INTELLECTUAL PROPERTY

6.1 License.

6.1.1 License to Celgene . Subject to the terms and on the conditions set forth in this License Agreement, and solely with respect to the Licensed Candidates, Licensed Products and Licensed Diagnostic Products that are the subject of this License Agreement, Juno hereby grants and shall cause (within [***] after the License Agreement Effective Date) its Affiliates to grant to Celgene (a) an exclusive [***], royalty-bearing right and license, with the right to grant sublicenses through multiple tiers (subject to Section 6.1.3), under (i) the Juno Licensed IP, (ii) Juno’s and its Affiliates’ rights in the Collaboration IP, and (iii) Juno’s and its Affiliates’ interest in the Joint Collaboration IP, and (b) a non-exclusive, royalty-free right and license, with the right to grant sublicenses (subject to Section 6.1.3), under Patents and Know-How [***] Covering or claiming the [***], in each case of (a) and (b) [***] (A) to conduct Research, Development, Manufacture [***], and Commercialization Activities for Licensed Candidates, Licensed Products and Licensed Diagnostic Products in the Field in the ROW Territory in accordance with the License Development Plan and/or License Commercialization Plan, and (B) if Celgene has exercised the Commercialization Opt-In Right pursuant to Section 3.2.2, to conduct Commercialization Activities that are [***] in the North America Territory. Juno shall [***] upon written notice to Celgene [***]; provided that (a) [***], (b) [***], and (c) [***] .

6.1.2 License to Juno . Subject to the terms and on the conditions set forth in this License Agreement, and solely with respect to the Licensed Candidates, Licensed Products and Licensed Diagnostic Products that are the subject of this License Agreement, Celgene hereby grants and shall cause (within [***] after the License Agreement Effective Date) its Affiliates to grant to Juno (a) an exclusive [***], royalty-free right and license, with the right to grant sublicenses through multiple tiers (subject to Section 6.1.3), under (i) the Celgene Relevant Licensed IP, (ii) Celgene’s and its Affiliates’ rights in the Collaboration IP, and (iii) Celgene’s and its Affiliates’ interest in the Joint Collaboration IP, and (b) a non-exclusive, royalty-free right and license, with the right to grant sublicenses (subject to Section 6.1.3), under Patents and Know-How [***] Covering or claiming the [***], in each case of (a) and (b) [***] (A) to conduct Research, Development, Manufacture [***] and Commercialization Activities for Licensed Candidates, Licensed Products and Licensed Diagnostic Products in the Field (1) in the

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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North America Territory in accordance with the License Development Plan and/or License Commercialization Plan, and (2) in the China Territory, and (B) if Juno has exercised the Commercialization Opt-In Right pursuant to Section 3.3.1, for Juno to conduct Commercialization Activities that are [***] for ROW Territory Administration in the Major EU Market Countries. Celgene shall [***] upon written notice to Juno [***]; provided that (a) [***], (b) [***], and (c) [***].

6.1.3 Sublicenses .

(a) Celgene shall have the right to grant sublicenses within the scope of the license granted to Celgene under Section 6.1.1 as follows: (i) with respect to the right and license granted to Celgene under Section 6.1.1(a), through multiple tiers, [***], (ii) with respect to the right and license granted to Celgene under 6.1.1(b), [***], [***], and (iii) otherwise [***].

(b) Juno shall have the right to grant sublicenses within the scope of the license granted to Juno under Section 6.1.2 as follows: (i) with respect to the right and license granted to Juno under Section 6.1.2(a), through multiple tiers, [***], (ii) with respect to the right and license granted to Juno under Section 6.1.2(b), [***], [***], and (iii) otherwise [***].

(c) Each sublicense granted by either Party under this Section 6.1.3 shall be subject to and consistent with the terms and conditions of this License Agreement. If a Party grants a sublicense to [***], it shall [***].

(d) Notwithstanding the foregoing, if [***] undergoes [***], and [***] thereafter [***], then following the effective date of such [***], [***] shall not be [***] to [***].

6.1.4 Rights Retained by the Parties . For purposes of clarity, each Party retains the rights under Know-How and Patents Controlled by such Party not expressly granted to the other Party pursuant to this License Agreement.

6.1.5 No Implied Licenses . Except as explicitly set forth in this License Agreement, neither Party shall be deemed by estoppel, implication or otherwise to have granted the other Party any license or other right under this License Agreement to any intellectual property of such Party.

6.1.6 Section 365(n) of the Bankruptcy Code . All licenses granted under this License Agreement are deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as defined in Section 101 of such Code. Each Party, as licensee, may fully exercise all of its rights and elections under the Bankruptcy Code. The Parties further agree that, if a Party elects to retain its rights as a licensee under any Bankruptcy Code, such Party shall be entitled to complete access to any technology licensed to it hereunder and all embodiments of such technology. Such embodiments of the technology shall be delivered to the licensee Party not later than: (a) the commencement of bankruptcy proceedings against the licensor, upon written request, unless the licensor elects to perform its obligations under this License Agreement, or (b) if not delivered under Section 6.1.6(a), upon the rejection

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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of this License Agreement by or on behalf of the licensor, upon written request. Any agreements supplemental hereto will be deemed to be “agreements supplementary to” this License Agreement for purposes of Section 365(n) of the Bankruptcy Code.

6.2 Ownership.

6.2.1 Inventorship . Inventorship of Inventions shall be determined by application of U.S. patent law pertaining to inventorship.

6.2.2 Ownership . Ownership of Inventions and intellectual property rights therein arising from each of the Parties’ activities under this License Agreement shall be determined in accordance with Sections 7.2.2, 7.2.3, 7.2.4 and 7.2.5 of the Master Collaboration Agreement.

6.2.3 Cooperation and Allocation . Sections 7.2.6, 7.2.7 and 7.2.8 of the Master Collaboration Agreement shall apply to all Inventions and intellectual property rights therein, that arise in whole or in part as a result of the Parties’ activities under this License Agreement.

6.3 Prosecution and Maintenance of Patents . Subject to Section 6.7, Prosecution and Maintenance of all Patents directed to any Inventions [***] shall be carried out in accordance with Section 7.3 of the Master Collaboration Agreement. Additionally, Celgene shall keep Juno informed as to [***] with respect to the Prosecution and Maintenance of Patents licensed to Juno under Section 6.1.2(a), and Juno shall keep Celgene informed as to [***] with respect to the Prosecution and Maintenance of Patents licensed to Celgene under Section 6.1.1(a). Celgene shall [***] with respect to any Patent Controlled by Celgene licensed to Juno under Section 6.1.2(a), and Juno shall provide Celgene [***] with respect to any Patent Controlled by Juno licensed to Celgene under Section 6.1.1(a).

6.4 Defense of Claims Brought by Third Parties.

6.4.1 Notice . If a Party becomes aware of any actual or potential claim alleging that the Research, Development, Manufacture or Commercialization of the Licensed Target, any Licensed Candidate, any Licensed Product or any Licensed Diagnostic Product, does (or would if carried out) infringe the intellectual property rights of any Third Party anywhere in the North America Territory or the ROW Territory, such Party shall [***]. In any such instance, the Parties shall [***].

6.4.2 Costs . The costs and expenses incurred by the Parties in connection with defense of any claim described in Section 6.4.1 shall be [***], unless otherwise agreed in writing by the Parties. For clarity, this Section 6.4.2 is intended to address [***], and if as a result of any such defense of such claim in the [***] Territory, Celgene [***], Section 5.4.2 may apply to [***].

6.5 Enforcement of Patents .

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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6.5.1 Notice . If any Party learns of an infringement or suspected or threatened infringement by a Third Party with respect to any Patent licensed to Celgene pursuant to Section 6.1.1 or a Patent that is licensed to Juno pursuant to Section 6.1.2, including actual or alleged infringement under 35 USC §271(e)(2) that is or would be infringing activity involving the using, making, importing, offering for sale or selling of compounds or products that are substantially the same as Licensed Candidates, Licensed Products or Licensed Diagnostic Products (“ License Competitive Infringement ”), such Party shall [***] of such License Competitive Infringement. For any License Competitive Infringement, each Party shall [***].

6.5.2 Scope of Enforcement Rights . As between the Parties, and subject to Sections 6.5.3, 6.6 and 6.7:

(a) Celgene shall have the [***] right,[***], to institute, prosecute, and control any action or proceeding with respect to any License Competitive Infringement occurring [***] Territory, and Juno shall have the [***] right, [***] to institute, prosecute, and control any action or proceeding with respect to any License Competitive Infringement occurring [***]; in each case, only with respect to any Patent (i) that [***], and (ii) that (A) [***], or (B) is (1) included in the [***], and (2) [***] (the Patents in this Section 6.5.2(a), the “ Licensed Product Patents ”).

(b) With respect to any Patent that is not a Licensed Product Patent and (i) that (A) [***], and (B) is (1) included in [***], or (2) included in [***], or (ii) that does not [***], and (A) is included in [***] or (B) (1) is included in [***] and (2) [***], then in each of (i) and (ii), (x) [***] institute, prosecute, and control any action or proceeding with respect to any License Competitive Infringement in the North America Territory, and (y) [***] institute, prosecute, or control any action or proceeding with respect to any License Competitive Infringement in the ROW Territory [***].

(c) With respect to any Patent that is not a Licensed Product Patent and (i) that (A) [***], and (B) is (1) included in [***], or (2) included in [***], or (ii) that does not [***], and (A) is included in [***], or (B) (1) is included [***] and (2) [***], in each of (i) and (ii), (x) [***] institute, prosecute, and control any action or proceeding with respect to any License Competitive Infringement in the ROW Territory, and (y) [***] institute, prosecute, or control any action or proceeding with respect to any License Competitive Infringement in the North America Territory [***].

(d) With respect to any Patent that does not [***] Licensed Candidates, Licensed Products, or Licensed Diagnostic Products, [***], or (ii) (A) is [***], (B) is included in [***], and (C) does not [***], in each of (i) and (ii), [***] institute, prosecute, and control any action or proceeding with respect to any License Competitive Infringement relating to such Patent in the ROW Territory and/or the North America Territory, [***].

(e) With respect to any Patent that does not [***] Licensed Candidates, Licensed Products, or Licensed Diagnostic Products, [***] and that (i) is [***], or (ii) (A) is [***], (B) is [***], and (C) does not [***], in each of (i) and (ii), [***] institute, prosecute and control any action or proceeding with respect to any License Competitive Infringement relating to such Patent in the ROW Territory and/or the North America Territory, [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

33


(f) With respect to any Patent that is jointly owned by the Parties and is included in the Collaboration IP or the Joint Collaboration IP (excluding any Licensed Product Patent and excluding any Patent that Covers or claims the [***]):

(i) that [***], [***], to institute, prosecute, and control any action or proceeding with respect to any License Competitive Infringement occurring in the ROW Territory, and [***], to institute, prosecute, and control any such action or proceeding with respect to any License Competitive Infringement occurring in the North America Territory, provided that [***]; and

(ii) that [***] Licensed Candidates, Licensed Products, or Licensed Diagnostic Products, or the [***].

(g) Unless otherwise agreed by the parties, and subject to Sections 6.5.3 and 6.5.4, any rights granted to either Party to institute, prosecute, and control any action or proceeding with respect to any License Competitive Infringement under Sections 6.5.2(a)-(f) are, in each case by counsel of the enforcing Party’s own choice, in such Party’s own name and under such Party’s direction and control, provided that with respect to any such action or proceeding in relation to Licensed Candidates, Licensed Products or Licensed Diagnostic Products, the enforcing Party shall [***], and shall [***]. Such rights granted to such Party shall include, if applicable, the right to perform, with respect to such actions with respect to License Competitive Infringement, [***] reference product sponsor or equivalent set forth in the Hatch-Waxman Act or Public Health Service Act (or applicable ROW Territory equivalent of either of the foregoing), [***], and if the enforcing Party is limited in performing such actions, the other Party shall reasonably cooperate to enable the enforcing Party to perform such actions.

(h) Timing . The Party with the first right (and for clarity, not the sole right) to institute, prosecute, and control any action or proceeding with respect to any Patent described in Section 6.5.1 and involving License Competitive Infringement (each such action or proceeding, a “ License Enforcement Proceeding ”) will have a period of [***] after its receipt or delivery of notice and evidence pursuant to Section 6.5.1 or receipt of written notice from a Third Party that reasonably evidences License Competitive Infringement, to elect to so enforce the relevant Patent(s) in the applicable jurisdiction (or to settle or otherwise secure the abatement of such License Competitive Infringement), provided however, that such period will be (a) more than [***] to the extent applicable Law prevents earlier enforcement of such Patent (such as the enforcement process set forth in or under the Hatch-Waxman Act), and provided further that if such period is extended because applicable Law prevents earlier enforcement, the enforcing Party shall have until the date that is [***] following the date upon which applicable Law first permits such License Enforcement Proceeding, and (b) less than [***] to the extent that a delay in bringing such License Enforcement Proceeding against such alleged Third Party infringer would limit or compromise the remedies (including monetary relief, and stay of regulatory

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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approval) available against such alleged Third Party infringer. In the event the enforcing Party [***] before the first to occur of (i) the expiration of the applicable period of time set forth in the preceding subsections (a) and (b), or ii) [***] before the expiration of any time period under applicable Law, that would, if a License Enforcement Proceeding was not filed within such time period, limit or compromise the remedies available from such License Enforcement Proceeding, it will [***] and in the case where such other Party [***] the applicable Patent with respect to such License Competitive Infringement in the applicable jurisdiction, such other Party will thereafter [***] enforce the applicable Patent (such action, a “ License Step-In Proceeding ”) at such other Party’s expense.

6.5.3 Sole Enforcement and Defense for [***] . Notwithstanding anything to the contrary herein, with respect to any License Competitive Infringement:

(a) [***]; and

(b) [***].

6.5.4 Right to Participate; Joinder . The non-enforcing Party in relation to any enforcement action or proceeding set forth in Section 6.5.2 or 6.5.4, will have the right, at its own expense and by counsel of its choice, to be represented in, or participate in any such action or proceeding. In the case of any License Enforcement Proceeding or License Step-In Proceeding, at the enforcing Party’s written request, and at the enforcing Party’s expense (subject to Section 6.5.9), the other Party will join any such action or proceeding as a party and will use Commercially Reasonable Efforts to cause any Third Party as necessary to join such action or proceeding as a party if doing so is necessary for the purposes of establishing standing or is otherwise required by applicable Law to pursue such action or proceeding. All time periods set forth in Section 6.5 shall be subject to applicable Law, which may prevent earlier enforcement.

6.5.5 Cooperation . In addition to the obligations set forth in Sections 6.5.4 and 6.5.5, each other Party will provide to the Party enforcing any such rights under Section 6.5 reasonable assistance and cooperation in such enforcement, at such enforcing Party’s request and expense. The enforcing Party will keep the other Party regularly informed of the status and progress of such enforcement efforts. The Parties will coordinate any License Enforcement Proceeding through the Patent Committee. Each Party bringing any such action or proceeding in accordance with this Section 6.5 shall have an obligation to consult with the other Party and will take comments of such other Party into good faith consideration with respect to the infringement, claim construction, or defense of the validity or enforceability of any claim in any Patent that is the subject of such proceeding, provided that the foregoing shall not apply to any such action or proceeding as it relates to (a) [***], or (b) [***]. Only with respect to any Patent within the [***] that [***], the Parties shall [***].

6.5.6 Third Party Rights . Notwithstanding Sections 6.5.1 through 6.5.6, each Party’s rights to enforce a Patent pursuant to this Section 6.5 or to Defend against a challenge in any action or proceeding described in Section 6.4, shall be subject to the applicable provisions of

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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any agreements between a Party and its licensor(s) of such Patent. In the event of any conflict between this Section 6.5 and such other agreements between a Party (and/or its Affiliates) and its/their licensor(s), the provisions of such other agreements shall control.

6.5.7 Inter Partes Review and Re-Examination Proceedings . If either Party becomes aware of any actual or potential inter partes review, re-examination or post grant review proceedings (but excluding [***]) involving any [***], such Party shall so notify the other Party. The Party having the right to bring an enforcement action pursuant to this Section 6.5 with respect to such Patent shall have the right to assume responsibility for the Defense thereof, with the other Party having backup rights therefor to the extent provided to such Party in the context of an action to enforce such Patent, with the costs of such action [***]. If neither Party has a right to bring an enforcement action pursuant to this Section 6.5 with respect to such Patent, then the Party Controlling such Patent shall have the right to assume responsibility for the Defense thereof.

6.5.8 Settlement . A settlement or consent judgment or other voluntary final disposition of an action or proceeding under this Section 6.5 may be [***]; provided, however, that any such settlement, consent judgment or other disposition of any action or proceeding by the Party under this Section 6.5 shall not, without the consent of such other Party (such consent not to be unreasonably withheld), (a) [***] the Party not bringing or Defending such action or proceeding, (b) [***] the Party not bringing or Defending such action or proceeding [***], (c) [***] the Party not bringing or Defending such action or proceeding, or (d) [***] the Party not bringing or Defending such action or proceeding[***].

6.5.9 Costs and Recoveries . Except as otherwise set forth in this Section 6.5, each Party shall [***] in connection with its activities under this Section 6.5. If a Party commences a License Enforcement Proceeding or Defends an action under this Section 6.5, [***] for such action or proceeding. All internal and external costs and expenses [***] in pursuing any License Enforcement Proceeding or Defense of an action or proceeding under this Section 6.5 shall be [***] such action, suit or proceeding. Any [***] in any License Enforcement Proceeding or Defense of an action under this Section 6.5 shall be shared as follows:

(a) the amount of such damages or other sums actually received by the Party controlling such License Enforcement Proceeding or Defense of an action under this Section 6.5, shall first be subject to Article 8, if applicable, and then shall be applied to reimburse all out-of-pocket costs and expenses incurred by each Party directly in connection with such License Enforcement Proceeding or Defense of an action under this Section 6.5 (including, for this purpose, [***]), and if such recovery is insufficient to cover all such costs and expenses of both Parties, it shall be [***]; and

(b) any remaining proceeds in case of suits with respect to a License Enforcement Proceeding or Defense of an action in the North America Territory or the ROW Territory relating to any Licensed Candidate, Licensed Product or Licensed Diagnostic Product under this Section 6.5 shall be allocated such that [***] of such remaining proceeds and [***] of such remaining proceeds, unless the Parties otherwise agree in writing.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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6.6 Patent Term Extensions .

6.6.1 If, during the License Term, either Party wishes to apply for or obtain any patent term extensions, restorations, or supplementary protection certificates (in each case based on delays or activities associates with seeking regulatory approval) under applicable Laws (such extensions, restorations and certificates, collectively, “ Patent Term Extensions ) for a Patent [***] any Licensed Candidate, Licensed Product or associated Licensed Diagnostic Product [***], and that [***] (“ License Covering Patent ”), in the North America Territory or the ROW Territory, subject to Section 6.6.3, then Section 7.6 of the Master Collaboration Agreement shall apply to determine whether such Patent Term Extension shall be sought or obtained, provided that if the Parties are unable to reach mutual agreement regarding whether to seek or obtain such Patent Term Extension then the following shall apply:

(a) if such License Covering Patent is [***], then notwithstanding anything to the contrary in Section 7.6 of the Master Collaboration Agreement, [***] shall have the right to make the final decision as to whether such Patent Term Extension shall be sought or obtained in [***] and [***] shall have the right to make the final decision as to whether such Patent Term Extension shall be sought or obtained in [***];

(b) if such License Covering Patent (i) [***] Licensed Candidates, Licensed Products or Licensed Diagnostic Products, [***] and (ii) (A) is included in [***] or (B) is (1) included in [***] and (2) [***], then (x) if such License Covering Patent is [***], then in [***], [***] shall have the right to make the final decision on whether to seek or obtain a Patent Term Extension, and in [***], [***] may seek or obtain a Patent Term Extension for such License Covering Patent [***], and (y) if such License Covering Patent is [***], then in [***] shall have the right to make the final decision on whether to seek or obtain a Patent Term Extension, and in [***], [***] may seek or obtain a Patent Term Extension for such License Covering Patent [***];

(c) if such License Covering Patent is [***] and [***], then if such License Covering Patent:

(i) is (A) [***] or (B) [***], then (1) in [***], [***] may seek or obtain a Patent Term Extension for such License Covering Patent [***], and (2) in [***], [***] shall have the final decision on whether to seek or obtain a Patent Term Extension for such License Covering Patent;

(ii) is (A) [***] or (B) [***], then (1) in [***], [***] may seek or obtain a Patent Term Extension for such License Covering Patent, [***], and (2) in [***], [***] shall have the final decision on whether to seek or obtain a Patent Term Extension for such License Covering Patent;

(d) if such License Covering Patent is [***] and is [***], then [***] may seek or obtain a Patent Term Extension for such License Covering [***] or in [***]; and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(e) if such License Covering Patent [***], then if such License Covering Patent:

(i) is (A) [***] or (B) [***], then (1) in [***], [***] shall have the right to make the final decision on whether to seek or obtain a Patent Term Extension for such License Covering Patent, and (2) in [***], [***] shall have the right to make a final decision with respect to such Patent Term Extension, provided that [***]; or

(ii) is (A) [***] or (B) [***], then (1) in the [***] Territory, [***] shall have the right to make the final decision on whether to seek or obtain a Patent Term Extension for such License Covering Patent, and (2) in the [***] Territory, [***] shall have the right to make a final decision with respect to such Patent Term Extension, provided that [***] with respect to such Patent Term Extension.

6.6.2 Notwithstanding anything to the contrary herein or in the Master Collaboration Agreement, Juno shall have no right to seek or obtain Patent Term Extension, without [***], for any Patent [***]; and Celgene have no right to seek or obtain Patent Term Extension, without [***], for any Patent [***].

6.7 [***] . Notwithstanding anything to the contrary in Sections 6.3 through 6.6, or in the Master Collaboration Agreement, (a) in no event shall Celgene have any rights to Prosecute and Maintain, enforce or Defend any Patent [***] and (b) in no event shall Juno have any rights to Prosecute and Maintain, enforce or defend any Patent that [***].

6.8 [***] Patents. Section 7.8 of the Master Collaboration Agreement shall apply.

6.9 Regulatory Data Protection. To the extent required or permitted by applicable Law, the Commercialization Lead Party in a given country will use Commercially Reasonable Efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities in such country during the License Term, all applicable Patents for any Licensed Product that the Commercialization Lead Party [***], Commercialize, such listings to include all so called “Orange Book” listings required under the U.S. Hatch-Waxman Act or the equivalent thereof outside of the U.S., if applicable. Prior to such listings, the Parties will [***] to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, the Commercialization Lead Party in a country will [***] as to the listing of all applicable Patents for such Licensed Product, regardless of which Party owns such Patent.

6.10 Third Party Payments. Notwithstanding the foregoing, if Juno or its Affiliates are required, pursuant to any agreement with a Third Party, to make any payments to such Third Party based on the sales of Licensed Products by Celgene, its Affiliates and Sublicensees under this License Agreement (a “License Third Party Payment”) pursuant to (a) any Juno Upstream Agreement, or (b) any Third Party License entered into between Juno and any Third Party after the License Agreement Effective Date, then [***], provided that [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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ARTICLE 7

UPSTREAM AGREEMENTS

7.1 Upstream Obligations. Celgene and Juno each acknowledge and agree that all licenses granted under this License Agreement, to the extent they constitute sublicenses under intellectual property rights owned by a Third Party and licensed or sublicensed to Juno or Celgene under a Juno Upstream Agreement or a Celgene Upstream Agreement, as applicable, are subject to the relevant terms and conditions of such Juno Upstream Agreements or Celgene Upstream Agreements, as applicable. Any exclusive licenses that are granted under this License Agreement that constitute sublicenses under such Juno Upstream Agreements or Celgene Upstream Agreements, as applicable, are exclusive only to the extent of the exclusive nature of the license granted to Juno or Celgene under such Juno Upstream Agreements or Celgene Upstream Agreements, as applicable.

ARTICLE 8

INDEMNIFICATION; INSURANCE

8.1 Indemnification by Celgene. Celgene shall indemnify, defend and hold harmless the Juno Indemnitees, from and against any and all Damages to the extent arising out of or relating to, directly or indirectly, any Claim based upon:

(a) the [***] under this License Agreement;

(b) any [***] under this License Agreement; or

(c) [***], in each case, resulting from any of the foregoing activities described in this Section 8.1(c); provided that Celgene shall have no obligation to indemnify, defend and hold harmless the Juno Indemnitees under this Section 8.1(c) from or against any Damages arising out of or relating to, directly or indirectly, any Claim [***]; it being understood and agreed that this Section 8.1(c) [***];

in each case, provided however that, such indemnity shall not apply to the extent Juno has an indemnification obligation pursuant to Section 8.2 for such Damage.

8.2 Indemnification by Juno. Juno shall indemnify, defend and hold harmless the Celgene Indemnitees, from and against any and all Damages to the extent arising out of or relating to, directly or indirectly, any Claim based upon:

(a) the [***] under this License Agreement;

(b) any [***]; or

(c) [***], in each case, resulting from any of the foregoing activities described in this Section 8.2(c); provided that Juno shall have no obligation to indemnify, defend and hold harmless the Celgene Indemnitees under this Section 8.2(c) from or against any Damages arising out of or relating to, directly or indirectly, any Claim [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(d) any [***], in each case, resulting from any of the foregoing activities described in this Section 8.2(d);

in each case, provided however that, such indemnity shall not apply to the extent Celgene has an indemnification obligation pursuant to Section 8.1 for such Damage.

8.3 Notice of Claims. A Claim to which indemnification applies under Section 8.1 or Section 8.2 shall be referred to herein as an “Indemnification Claim.” If the Indemnitee intends to claim indemnification under this Article 8, the Party claiming indemnification (the “ Indemnitee ”) shall notify the indemnifying Party (the “ Indemnitor ”) in writing, promptly upon becoming aware of an Indemnification Claim, describing in reasonable detail the facts giving rise to the Indemnification Claim; provided, that an Indemnification Claim in respect of any action at law or suit in equity by or against a Third Party as to which indemnification shall be sought shall be given promptly after the action or suit is commenced (provided that the Indemnitee is aware of such commencement); and provided further, that the failure by an Indemnitee to give such notice shall not relieve the Indemnitor of its indemnification obligation under this License Agreement except and only to the extent that the Indemnitor is actually prejudiced as a result of such failure to give notice.

8.4 Indemnification Procedures. If an Indemnitee receives written notice of a Claim that the Indemnitee believes may result in a claim for indemnification under this Article 8, such Indemnitee shall deliver an Indemnification Claim to the Indemnitor in accordance with the provisions of Section 8.3. If the [***], then the Indemnitor shall have the right to assume and control the defense of the Claim, at its own expense with counsel selected by it and reasonably acceptable to the Indemnitee, by delivering written notice of its assumption of such defense to the Indemnitee within [***] of its receipt of notice of such Claim from the Indemnitor (but the Indemnitor shall in any event have the right to assume and control the defense of a Claim [***], whichever is first); provided, however, that the Indemnitee shall have the right to retain its own counsel, with the reasonable fees and expenses to be paid by the Indemnitor, if (a) representation of the Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential conflict of interests between such Indemnitee and Indemnitor, (b) the Indemnitor has failed within a reasonable time to retain counsel, (c) the Indemnitee shall have reasonably concluded that there may be legal defenses available to it that are different from or in addition to those available to the Indemnitor, or (d) [***]. If the Indemnitor assumes and controls the defense of such Claim, the Indemnitor shall keep the Indemnitee reasonably apprised of the status of the Claim and the Indemnitee shall be entitled to otherwise monitor such Claim at its sole cost and expense. If the Claim [***] against or from the Indemnitee or if the Indemnitor does not assume the defense of the Claim as described in this Section 8.4, the Indemnitee shall be permitted to assume and control the defense of such Claim (but shall have no obligation to do so) and in such event shall be entitled to settle or compromise the Indemnification Claims in its sole and reasonable discretion, provided that if the Indemnitee is entitled to assume the defense of the Claim pursuant to this Section 8.4 solely because the Claim [***]) against or from the Indemnitee, then the Indemnitee shall not settle or compromise such Indemnification Claims in any manner that involves [***] without the prior written consent of the Indemnitor, which

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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consent the Indemnitor shall not unreasonably withhold, condition or delay. If the Indemnitor has assumed and controls the defense of the Claim in accordance with this Section 8.4, (i) the Indemnitee shall not settle or compromise the Indemnification Claim without the prior written consent of the Indemnitor, such consent not to be unreasonably withheld, conditioned or delayed and (ii) the Indemnitor shall not settle or compromise the Indemnification Claim in any manner that would result in the payment of amounts by the Indemnitee, impose any other obligation on the Indemnitee or otherwise have an adverse effect on the Indemnitee’s rights or interests (including any rights under this License Agreement or the Equity Purchase Agreement or the scope or enforceability of any Patents or Know-How licensed by one Party to another Party pursuant to this License Agreement or any other Development & Commercialization Agreement, or the Master Collaboration Agreement), without the prior written consent of the Indemnitee. In each case, the Party that is not controlling the defense of any Claim shall reasonably cooperate with the Party that is controlling the defense of such Claim, at the non-controlling Party’s expense and shall make available to the controlling Party all pertinent information under the control of the non-controlling Party, which information shall be subject to Article 8 of the Master Collaboration Agreement. Each Party shall use Commercially Reasonable Efforts to avoid production of Confidential Information of the other Party (consistent with applicable Law and rules of procedure), and to cause all communications among employees, counsel and other representatives of such Party in connection with activities under this Section 8.4 to be made so as to preserve any applicable attorney-client or work-product privileges.

8.5 LIMITATION OF LIABILITY. EXCEPT (A) FOR A BREACH OF [***] OR (B) FOR CLAIMS THAT ARE SUBJECT TO INDEMNIFICATION UNDER THIS ARTICLE 8 OR (C) FOR DAMAGES DUE TO THE [***] OF THE LIABLE PARTY, NEITHER JUNO NOR CELGENE, NOR ANY OF THEIR RESPECTIVE AFFILIATES WILL BE LIABLE TO THE OTHER PARTY TO THIS LICENSE AGREEMENT OR ITS AFFILIATES FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE OR EXEMPLARY DAMAGES OR LOST PROFITS OR LOST DATA, WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY), INDEMNITY OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE.

ARTICLE 9

LICENSE TERM AND TERMINATION

9.1 License Term; Expiration .

9.1.1 License Term . This License Agreement shall become effective on the License Agreement Effective Date and, unless earlier terminated pursuant to this Article 10, shall remain in effect until it expires (the “ License Term ”):

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(a) on a Licensed Product-by-Licensed Product and country-by-country basis, this License Agreement shall expire on the date of the expiration of all applicable Licensed Product Royalty Terms with respect to such Licensed Product in such country;

(b) on a Licensed Diagnostic Product-by-Licensed Diagnostic Product and country by country basis, this License Agreement shall expire on the date of the expiration of all applicable Licensed Diagnostic Product Royalty Terms with respect to such Licensed Diagnostic Product in such country; and

(c) in its entirety upon the expiration of all applicable Licensed Product Royalty Terms and Licensed Diagnostic Product Royalty Terms under this License Agreement with respect to all Licensed Products and all Licensed Diagnostic Products in all countries in the ROW Territory.

9.1.2 Effect of Expiration . After the expiration of the License Term pursuant to Section 9.1.1 above, the following terms shall apply:

(a) Licenses after Expiration for Licensed Product or Licensed Diagnostic Product . After expiration of the License Term (but not after early termination) with respect to any Licensed Product or Licensed Diagnostic Product in a country in the Territory pursuant to Section 9.1.1(a), (i) Celgene shall have a fully-paid, royalty-free, irrevocable, non-terminable, worldwide right and license, with the right to grant sublicenses [***], under the [***] to Research, develop, manufacture, have manufactured, use, offer for sale, sell, import and otherwise commercialize such Licensed Product or Licensed Diagnostic Products, as applicable, in the Field in such country in the ROW Territory, for [***], and (ii) Juno shall have a fully-paid, royalty-free, irrevocable, non-terminable, worldwide right and license, with the right to grant sublicenses [***], under the [***], to Research, develop, manufacture, have manufactured, use, offer for sale, sell, import and otherwise commercialize such Licensed Product or Licensed Diagnostic Products, as applicable, in the Field in such country outside the ROW Territory. Such licenses shall be exclusive with respect to the Patents and Know-How that were subject to an exclusive license granted to the relevant Party pursuant to Section 6.1.1 or 6.1.2, and otherwise shall be non-exclusive.

(b) Licenses after Expiration of License Agreement. After expiration of the License Term (but not after early termination) with respect to this License Agreement in its entirety pursuant to Section 9.1.1(c), (i) Celgene shall have a fully-paid, royalty-free, irrevocable, non-terminable, worldwide right and license, with the right to grant sublicenses [***], under the [***] to develop, manufacture, have manufactured, use, offer for sale, sell, import and otherwise commercialize Licensed Products and Licensed Diagnostic Products in the Field in the ROW Territory, for so long as it continues to do so, and (ii) Juno shall have a fully-paid, royalty-free, irrevocable, non-terminable, worldwide right and license, with the right to grant sublicenses [***], under the [***], to develop, manufacture, have manufactured, use, offer for sale, sell, import and otherwise commercialize Licensed Products and Licensed Diagnostic Products in the Field outside the ROW Territory. Such licenses shall be exclusive with respect to the Patents and Know-How that were subject to an exclusive license granted to the relevant Party pursuant to Section 6.1.1 or 6.1.2, and otherwise shall be non-exclusive.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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9.2 Termination Without Cause.

9.2.1 Termination by Celgene for Convenience . At any time during the License Term, Celgene shall have the right, at its sole discretion, to terminate this License Agreement in its entirety, upon [***] prior written notice to Juno hereunder; it being understood and agreed that Celgene shall be entitled to terminate upon [***] written notice at any time it reasonably determines that such termination is necessary to comply with any Antitrust Law.

9.2.2 Termination by Celgene for [***] . Celgene shall have the right to terminate this License Agreement immediately on a Licensed Candidate-by-Licensed Candidate basis upon written notice to Juno based on [***]. Upon such termination for Safety Reasons, subject to the terms and conditions of this License Agreement, Celgene shall be responsible, at its expense, for the wind-down, if any, of any Development of the applicable Licensed Candidate, and corresponding Licensed Product (including any Clinical Trials for the applicable Licensed Candidate or Licensed Product being conducted by or on behalf of Celgene) and any Commercialization activities for the applicable Licensed Candidate or Licensed Product for which it is the Lead Party or for which it is performing other Development and/or Commercialization activities. Such termination shall become effective upon the date that the Parties agree in writing that such wind-down is complete. Upon such termination for [***], all licenses granted by Juno to Celgene under this License Agreement shall terminate solely with respect to the applicable Licensed Candidate or Licensed Product. For purposes of this License Agreement, “[***]” means that [***], determines that Development of Licensed Candidates and/or Licensed Products should be discontinued [***] to Develop or Commercialize or to continue to Develop or Commercialize it. If this License Agreement is terminated pursuant to this Section 9.2.2, then subject to applicable data privacy laws, and on Juno’s request, Celgene shall provide Juno with [***], to the extent not previously provided to Juno, solely for the purposes of [***]. Upon Juno’s [***], Section 9.8 shall apply except for Section 9.8.2(c) and 9.8.2(h).

9.3 Termination for Breach.

9.3.1 Termination by Either Party for Breach . Subject to certain variations set forth in Section 9.3.2 with respect to a material breach by Celgene of its obligation to use Commercially Reasonable Efforts pursuant to Section 2.2.1, this License Agreement and the rights granted herein may be terminated by either Party for the material breach by the other Party of this License Agreement [***], provided, that if the breaching Party has not cured such breach within [***] (or [***], in the case of Celgene’s payment obligations under this License Agreement, or the time period provided in Section 9.3.2 with respect to a material breach by Celgene of its obligation to use Commercially Reasonable Efforts) (the “ Cure Period ”) after the date of written notice to the breaching Party of such breach, which notice shall describe such breach in reasonable detail and shall state the non-breaching Party’s intention to terminate this

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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License Agreement pursuant to this Section 9.3.1. Notwithstanding the preceding sentence, the Cure Period for any allegation made in good faith as to a material breach under this License Agreement will run from [***].

9.3.2 Any such termination of this License Agreement under this Section 9.3 shall become effective at the end of the Cure Period, unless the breaching Party has cured any such breach or default prior to the expiration of such Cure Period, or, if such breach is not susceptible to cure within the Cure Period, then, the non-breaching Party’s right of termination shall be [***]. The Parties understand and agree that [***] for purposes of determining [***].

9.3.3 Additional Procedures for Termination by Juno for Failure of Celgene to Use Commercially Reasonable Efforts . If Juno wishes to exercise its right to terminate this License Agreement pursuant to Section 9.3.1 for Celgene’s material breach of its obligations to use Commercially Reasonable Efforts as set forth in Section 2.2.1, it shall provide to Celgene a written notice of its intent to exercise such right, which notice shall be labelled as a “notice of material breach for failure to use Commercially Reasonable Efforts,” and shall state the reasons and justification for such termination and [***]. For any such notice of breach by Juno, the Cure Period shall be [***], and shall become effective in accordance with Section 9.3.2.

9.3.4 Disagreement as to Material Breach . If the Parties reasonably and in good faith disagree as to whether there has been a material breach pursuant to either Section 9.3.1 or 9.3.2, the Party that disputes that there has been a material breach may contest the allegation by referring such matter, within thirty [***] for resolution to the Executive Officers, who shall meet promptly to discuss the matter, and determine, within [***], whether or not a material breach has occurred pursuant to Section 9.3.1 or 9.3.2, as applicable. If the Executive Officers are unable to resolve a dispute within such [***] period after it is referred to them, the matter will be resolved as provided in Section 12.7 of the Master Collaboration Agreement.

9.4 Termination for Patent Challenges.

9.4.1 Termination by Celgene for Patent Challenge . Celgene shall have the right to terminate this License Agreement upon written notice if Juno or any of its Affiliates (as defined in Section 1.2(a) of the Master Collaboration Agreement) challenges the validity, scope or enforceability, or otherwise opposes any Patent included in the [***] that is licensed to Juno under this License Agreement (other than as [***] be necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order); it being understood and agreed that Celgene’s right to terminate this License Agreement under this Section 9.4 shall not apply to any Affiliate of Juno (as defined in Section 1.2(a) of the Master Collaboration Agreement) that first becomes such an Affiliate as a result of or after the effective date of a Business Combination involving Juno, where such new Affiliate was undertaking any of the activities described in the foregoing clause prior to such Business Combination; provided that Celgene’s right to terminate this License Agreement under this Section 9.4 shall apply to such new Affiliate if Juno is the acquiror in such Business Combination and such new Affiliate does not terminate or otherwise cease such challenge or

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

44


opposition within [***] after the effective date of such Business Combination. If a Sublicensee of Juno challenges the validity, scope or enforceability of or otherwise opposes any Patent [***] under which such Sublicensee is sublicensed, then Juno shall, [***], terminate such sublicense. For the avoidance of doubt, an action by Juno or any Affiliate (as defined in Section 1.2(a) of the Master Collaboration Agreement) in accordance with Article 7 of the Master Collaboration Agreement to amend claims within a pending patent application of Celgene during the course of Juno’s Prosecution and Maintenance of such pending patent application or in defense of a Third Party proceeding, or to make a negative determination of patentability of claims of a patent application of Celgene or to abandon a patent application of Celgene during the course of Juno’s Prosecution and Maintenance of such pending patent application, shall not constitute a challenge under this Section 9.4.

9.4.2 Juno shall have the right to terminate this License Agreement upon written notice if Celgene or any Affiliate (as defined in Section 1.2(a) of the Master Collaboration Agreement) challenges the validity, scope or enforceability, or otherwise opposes any Patent included in the [***] that is licensed to Celgene under this License Agreement (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order); it being understood and agreed that Juno’s right to terminate this License Agreement under this Section 9.4 shall not apply to any Affiliate of Celgene (as defined in Section 1.2(a) of the Master Collaboration Agreement) that first becomes such an Affiliate as a result of or after the effective date of a Business Combination involving Celgene, where such new Affiliate was undertaking any of the activities described in the foregoing clause prior to such Business Combination; provided that Juno’s right to terminate this License Agreement under this Section 9.4 shall apply to such new Affiliate if Celgene is the acquiror in such Business Combination and such new Affiliate does not terminate or otherwise cease such challenge or opposition within [***] after the effective date of such Business Combination. If a Sublicensee of Celgene challenges the validity, scope or enforceability of or otherwise opposes any Patent included in the [***] under which such Sublicensee is sublicensed, then Celgene shall, upon [***], terminate such sublicense. For the avoidance of doubt, an action by Celgene or any Affiliate (as defined in Section 1.2(a) of the Master Collaboration Agreement) in accordance with Article 6 to amend claims within a pending patent application of Juno during the course of Celgene’s Prosecution and Maintenance of such pending patent application or in defense of a Third Party proceeding, or to make a negative determination of patentability of claims of a patent application of Juno or to abandon a patent application of Juno during the course of Celgene’s Prosecution and Maintenance of such pending patent application, shall not constitute a challenge under this Section 9.4.

9.5 Termination for Bankruptcy. If either Party makes a general assignment for the benefit of creditors, appoints or suffers appointment of a receiver or trustee over all or substantially all of its property, files a petition under any bankruptcy or insolvency act or has any such petition filed against it which is not dismissed, discharged, bonded or stayed within [***] after the filing thereof, the other Party may terminate this License Agreement in its entirety, effective immediately upon written notice to such Party. In connection therewith, the provisions of Section 6.1.6 shall apply.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

45


9.6 Termination for Breach of Standstill. Juno may terminate this License Agreement immediately upon written notice to Celgene, in the event that Juno exercises its right to terminate this License Agreement under Section 2.2 of the Voting and Standstill Agreement (as defined in the Master Collaboration Agreement) resulting in the termination of the Voting and Standstill Agreement.

9.7 Effects of Expiration or Termination .

9.7.1 License Upon Expiration . Upon expiration (but not upon earlier termination) of this License Agreement, the license granted to Celgene in Section 6.1.1 shall automatically convert to the applicable license set forth in Section 9.1.2, and the license granted to Juno in Section 6.1.2 shall automatically convert to the applicable license set forth in Section 9.1.2.

9.7.2 Termination by Celgene Pursuant to Section 9.2, or by Juno Pursuant to Section 9.3, 9.4, 9.5 or 9.6 . In the event this License Agreement is terminated by Celgene pursuant to Section 9.2 or by Juno pursuant to Section 9.3, 9.4, 9.5 or 9.6, then notwithstanding anything contained in this License Agreement to the contrary, upon the effective date of such termination:

(a) License Termination . All licenses granted to Celgene under this License Agreement shall terminate in their entirety, Celgene shall cease any and all Development, and Commercialization Activities with respect to all Licensed Candidates, Licensed Products and Licensed Diagnostic Products, and all rights in such Licensed Candidates, Licensed Products and Licensed Diagnostic Products granted by Juno to Celgene shall revert to Juno pursuant to Section 9.8;

(b) Return of Confidential Information . Each Party shall return or destroy all Confidential Information of the other Party pursuant to Article 8 of the Master Collaboration Agreement, unless such information is practiced by the receiving Party pursuant to licenses retained after any such termination under this License Agreement, another Development & Commercialization Agreement or the Master Collaboration Agreement; and

(c) Survival of License . The licenses granted in Sections 6.1.2 shall automatically convert to the applicable license set forth in Section 9.8.

(d) Ongoing Activities . If Celgene had exercised its right to participate in Commercialization Activities in the North America Territory pursuant to Section 3.3.2, and if Celgene is engaged in such activities at the time the termination of this License Agreement becomes effective, [***] will have the right [***]. [***] shall exercise the foregoing right by providing written notice to [***] thereof prior to the date that is [***] after the effective date of such termination, stating that [***]. Celgene shall [***].

9.7.3 Termination by Celgene Pursuant to Section 9.3, 9.4 or 9.5 . In the event this License Agreement is terminated by Celgene pursuant to Section 9.3, 9.4 or 9.5, then (a)

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

46


subject to Section 9.10, all rights and obligations of the Parties under this License Agreement shall terminate, except (i) the licenses granted in Sections 6.1.1 and 6.1.2, (ii) Celgene’s payment obligations set forth in Article 5, and (iii) Section 9.10, shall, in each of cases (i) through (iii), survive such termination, (b) each Party shall return or destroy any Confidential Information of the other Party pursuant to Article 8 of the Master Collaboration Agreement that is not necessary to practice any licenses retained by either Party following such termination under this License Agreement, another Development & Commercialization Agreement or the Master Collaboration Agreement, and (c) [***], unless such termination of this License Agreement is [***].

9.8 Juno Reversion Products.

9.8.1 Reversion . If this License Agreement terminates, except for any termination by Celgene pursuant to Section 9.3, 9.4 or 9.5, then all Licensed Candidates, Licensed Products and/or Licensed Diagnostic Products shall be deemed “ Juno Reversion Products ”. Celgene shall grant and hereby grants to Juno a non-exclusive, royalty-free, non-assignable (except as provided in Section 10.4) license, with the right to grant sublicenses [***], under [***] (a) [***], (b) [***], and (c) [***], in each case of (a) through (c), solely to Research, Develop, Manufacture, use, import, offer for sale, sell, and Commercialize Juno Reversion Products in the Territory in the Field.

9.8.2 Effects of Reversion . With respect to each Licensed Candidate, Licensed Product and Licensed Diagnostic Product that becomes a Juno Reversion Product:

(a) Celgene shall return to Juno within a reasonable time, at no cost to Juno, all Know-How within the Juno Licensed IP transferred by Juno to Celgene with respect to each such Juno Reversion Product;

(b) Except to the extent not permitted pursuant to any agreements between Celgene and a Third Party, Celgene shall provide to Juno, within a reasonable time, at Juno’s request, subject to Juno’s [***] pertaining to the applicable Juno Reversion Products [***] such Juno Reversion Products, including copies of (i) [***] Juno Reversion Products, and (ii) materials and documents relating to [***] Juno Reversion Products throughout the ROW Territory and/or the North America Territory (if applicable). For clarity, Juno shall have the right to use the foregoing [***] information, materials and data [***] of Juno Reversion Products or exercise of its rights under Section 6.1.2;

(c) Celgene shall provide [***] with Juno Reversion Products in the ROW Territory prior to reversion of such Juno Reversion Products to Juno, at Juno’s request [***];

(d) Celgene shall transfer within a reasonable time to Juno, at Juno’s request and at Juno’s expense, any and all Regulatory Filings pertaining to the applicable Juno Reversion Products in the ROW Territory in its possession or Control;

(e) with respect to any Licensed Candidate or Licensed Product that becomes a Juno Reversion Product as a result of termination of this License Agreement at a time during

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

47


which Celgene is conducting a Clinical Trial for such Licensed Candidate or Licensed Product, Celgene will, as directed by Juno, [***], if such termination is pursuant to Sections 9.3, 9.4, 9.5 or 9.6 (in each case by Juno), and otherwise [***];

(f) Celgene shall otherwise cooperate reasonably with Juno to provide a transfer of the materials described in Sections 9.8.2(a) through (e), such transfer to be completed within [***] after the Parties have identified the Know-How and Regulatory Filings to be transferred;

(g) As and to the extent a Third Party is manufacturing such Juno Reversion Product for Celgene, or for supply to Juno by Celgene, Celgene shall [***], to assist in [***]. If, at any time during the License Term, Celgene or an Affiliate of Celgene begins manufacturing any Licensed Candidate or Licensed Product, the Parties shall [***] of such Licensed Candidate or Licensed Product from Celgene or such Affiliate to Juno or Juno’s designee in the event such Licensed Candidate or Licensed Product becomes a Juno Reversion Product, which shall include [***]. Additionally, upon any Licensed Candidate or Licensed Product becoming a Juno Reversion Product, at Juno’s request, Celgene shall [***], for a price equal to [***];

(h) To the extent that Celgene owns any trademark(s) and/or domain names that [***] a Juno Reversion Product that [***] for the Commercialization of a Juno Reversion Product (as [***], but not including any marks that include, in whole or part, any corporate name or logo of Celgene), Juno shall have the right to [***]. Juno shall exercise such right by written notice to Celgene within [***] after such Licensed Candidate or Licensed Product becomes a Juno Reversion Product. The Parties shall [***] to Juno for up to [***] after Celgene receives any such written notice from Juno; and

(i) If Celgene has obtained a Third Party License with respect to such Juno Reversion Product and Juno is a sublicensee under such Third Party License, then [***] such Third Party License to the extent due with respect to the [***].

9.9 Survival of Sublicensees. Juno’s right to grant sublicenses under the licenses granted in Section 9.8 shall survive any termination of this License Agreement. With the exception of the foregoing, termination of this License Agreement shall be construed as a termination of any sublicense granted by either Party to any Sublicensee hereunder, provided however that such Sublicensee shall have the right to request that such Party grants to such Sublicensee a direct license. and such Party shall not unreasonably withhold its consent to any such request.

9.10 Surviving Provisions.

9.10.1 Accrued Rights; Remedies . Termination, relinquishment or expiration of this License Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of any Party prior to such termination, relinquishment or expiration, including the payment obligations under Article 5 hereof, and any and all damages or remedies (whether in law or in equity) arising from any breach hereunder. Such termination,

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

48


relinquishment or expiration shall not relieve any Party from obligations which are expressly indicated to survive termination of this License Agreement. Except as otherwise expressly set forth in this License Agreement, the termination provisions of this Article 10 are in addition to any other relief and remedies available to either Party under this License Agreement and at applicable Law.

9.10.2 Survival . Notwithstanding any provision herein to the contrary, any rights or obligations otherwise accrued hereunder (including any accrued payment obligations) shall survive the expiration or termination of this License Agreement. Further, the rights and obligations of the Parties set forth in the following Sections, Articles and Exhibits shall survive the expiration or termination of this License Agreement, in addition to those other terms and conditions that are expressly stated to survive termination or expiration of this License Agreement: (a) Sections 2.3.3(b), 2.3.7(b), 2.5 (as to activities conducted during the License Term and activities conducted by a Party following termination, where such Party retains rights and licenses pursuant to Section 9.7.3 (as to Celgene) or Section 9.8 (as to Juno)), 2.6.1 (as to License Materials transferred during the License Term), 2.6.2 (to the extent that the License Materials Receiving Party retains a license to use such License Materials following termination), 2.6.3 (as to License Materials transferred during the License Term), 2.7, 5.6.1, 6.1.3 (to the extent applicable), 6.1.4, 6.1.5, 6.1.6, 6.2, 6.5 (to the extent a Party retains rights or licenses after termination under [***]), except that for Section 6.5.9 shall apply only if [***]), 6.7, 6.8, 6.9 (last sentence, to the extent a party retains rights or license after termination), Article 7 (to the extent applicable to claims arising either during the License Term, or in the course of a Party’s exercise of its rights and licenses pursuant to Section 9.7.3 ([***]) or Section 9.8 (for Juno) after termination), Article 8 (to the extent applicable to claims arising either during the License Term, or in the course of a Party’s exercise of its rights and licenses pursuant to Section 9.7.3 (for Celgene) or Section 9.8 (for Juno) after termination), Sections 9.1.2, 9.7, 9.8, 9.9, 9.10, 9.11, Article 10, Exhibit A and Exhibit B; and (b) additionally, if Section 9.7.3 applies, Sections 2.3.2 (first sentence), 2.3.6(a), 3.1 (except that the rights under Sections 3.2 and 3.3 referenced in Section 3.1 shall not survive), Article 5, 6.1.1, 6.1.2, 6.6 ([***]), 6.10 (solely with respect to [***], on the same basis as during the License Term), and Exhibit C, and (c) additionally, if Section 9.1.2 applies, Sections 2.3.2 (first sentence), 2.3.6, 3.1 (except that the rights under Sections 3.2 and 3.3 referenced in Section 3.1 shall not survive) ; provided that such survival shall be limited to any specific time periods set forth in such Articles and Sections. Upon expiration of this License Agreement pursuant to Section 9.1.1, each Party shall return or destroy all Confidential Information of the other Party pursuant to Article 8 of the Master Collaboration Agreement, unless such information is practiced by the receiving Party pursuant to licenses retained after any such expiration under this License Agreement, another Development & Commercialization Agreement or the Master Collaboration Agreement.

9.11 Relationship to Other Agreements . Termination of this License Agreement shall not affect in any way the terms or provisions of the Master Collaboration Agreement, any other then-existing executed Development & Commercialization Agreement or the Equity Purchase Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

49


ARTICLE 10

MISCELLANEOUS

10.1 Confidentiality; Publicity.

10.1.1 Confidentiality . The confidentiality, non-disclosure and non-use obligations set forth in Article 8 of the Master Collaboration Agreement, including each Party’s rights and obligations with respect to publicity and publications set forth in Sections 8.6 and 8.7.2 of the Master Collaboration Agreement, shall apply to the Parties’ performance of all activities under this License Agreement.

10.1.2 Press Release . Upon or following the License Agreement Effective Date, the Parties may issue the form of press release agreed by the Parties pursuant to Section 8.6 of the Master Collaboration Agreement and attached hereto as Exhibit D . In all other cases, the issuance of any press release or other public statement by either Party or their respective Affiliates disclosing any information relating to this License Agreement, the activities hereunder, or the transactions contemplated hereby shall be subject to Section 8.6 of the Master Collaboration Agreement.

10.2 Disclaimer of Warranties. Except as otherwise expressly set forth in this License Agreement or the Master Collaboration Agreement, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY THAT ANY PATENTS ARE VALID OR ENFORCEABLE, AND EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. Without limiting the generality of the foregoing, each Party disclaims any warranties with regards to: (a) the success of any study or test, including the Licensed Program, commenced under this License Agreement; (b) the safety or usefulness for any purpose of the technology or materials, including any Licensed Candidate, Licensed Product or Licensed Diagnostic Product, it provides or discovers under this License Agreement; or (c) the validity, enforceability, or non-infringement of any intellectual property rights or technology it provides or licenses to the other Party under this License Agreement.

10.3 Applicability of Terms of Master Collaboration Agreement. In addition to those provisions of the Master Collaboration Agreement that are expressly stated in this License Agreement to apply to the Parties activities hereunder, Sections 12.1, 12.2, 12.3, 12.5, 12.6, 12.7, 12.8, 12.9, 12.11, 12.12, 12.13 12.14 and 12.15 of the Master Collaboration Agreement shall apply in full to the Party’s performance of all activities under this License Agreement. References to “Agreement in such sections shall refer to this License Agreement.

10.4 Assignment.

10.4.1 Generally . This License Agreement may not be assigned by any Party, nor may any Party delegate its obligations or otherwise transfer licenses or other rights created

 

50


by this License Agreement, except as expressly permitted hereunder without the prior written consent of the other Party, which consent will not be unreasonably withheld, delayed or conditioned.

10.4.2 Celgene . Notwithstanding the limitations in Section 10.4.1, Celgene Corp. and Celgene RIVOT may assign this License Agreement, or any rights or obligations hereunder in whole or in part, to (a) one or more Affiliates solely as provided in this Section 10.4.2 or (b) its successor in interest in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this License Agreement; provided however that, except in the case where Celgene Corp., or Celgene RIVOT, as applicable, [***], (i) Celgene Corp. or Celgene RIVOT, as applicable, provides Juno with at least [***] advance written notice of any such assignment(s), (ii) prior to such assignment(s), Celgene Corp. or Celgene RIVOT, as applicable, agrees in a written agreement delivered to Juno (and upon which Juno may rely) to remain fully liable for the performance of its obligations under this License Agreement by its assignee(s), and (iii) prior to such assignment(s), the assignee(s) agree in a written agreement delivered to Juno (and upon which Juno may rely) to assume performance of all such assigned obligations. If Celgene Corp. or Celgene RIVOT, as applicable, wishes to assign [***], Celgene Corp. or Celgene RIVOT, as applicable, will be permitted to do so conditioned on such [***].

10.4.3 Juno . Notwithstanding the limitations in Section 10.4.1, Juno may assign this License Agreement, or any rights or obligations hereunder in whole or in part, to (a) one or more Affiliates solely as provided in this Section 10.4.3 or (b) its successor in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this License Agreement; provided however that, except in the case where Juno [***], (i) Juno provides Celgene with at least [***] advance written notice of any such assignment(s), (ii) prior to such assignment(s), Juno agrees in a written agreement delivered to Celgene (and upon which Celgene may rely) to remain fully liable for the performance of its obligations under this License Agreement by its assignee(s), (iii) prior to such assignment(s), the assignee(s) agree in a written agreement delivered to Celgene (and upon which Celgene may rely) to assume performance of all such assigned obligations, (iv) in the case of any assignment(s) by Juno, all [***], and (v) all of the matters referred to in clauses (i), (ii), (iii) and (iv), as applicable, will be set forth in documentation [***] prior to any such assignment(s) [***] and in all cases will provide [***]. If Juno wishes to assign [***], it will be permitted to do so conditioned on [***].

10.4.4 All Other Assignments Null and Void . The terms of this License Agreement will be binding upon and will inure to the benefit of the successors, heirs, administrators and permitted assigns of the Parties. Any purported assignment in violation of this Section 10.4 will be null and void ab initio.

10.4.5 Business Combinations . Notwithstanding anything to the contrary in this License Agreement, with respect to any intellectual property rights controlled by the acquiring party or its Affiliates (if other than one of the Parties to this License Agreement) involved in any

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

51


Business Combination of either Party, such intellectual property rights shall not be included in the technology and intellectual property rights licensed to the other Party hereunder to the extent held by such acquirer or its Affiliate (other than the relevant Party to this License Agreement) prior to such transaction, or to the extent such technology is developed outside the scope of activities conducted with respect to the Collaboration, Licensed Program, Licensed Candidates, Licensed Products or related Licensed Diagnostic Products. The Juno Licensed IP and the [***] shall exclude any intellectual property [***] by a permitted assignee or successor and not developed in connection with the Collaboration, Licensed Program, Licensed Candidates, or Licensed Products, or related Licensed Diagnostic Products, Researched, Developed or Commercialized pursuant to this License Agreement, any other Development & Commercialization Agreement or the Master Collaboration Agreement.

10.5 Entire Agreement. This License Agreement, together with the attached Exhibits and Schedules, and the Master Collaboration Agreement, including its Exhibits and Schedules, contains the entire agreement by the Parties with respect to the subject matter hereof and supersedes any prior express or implied agreements, understandings and representations, either oral or written, which may have related to the subject matter hereof in any way, and any and all term sheets relating to the transactions contemplated by this License Agreement and exchanged between the Parties prior to the License Agreement Effective Date.

[Signature Page Follows]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

52


IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have caused this LICENSE AGREEMENT to be executed by their respective duly authorized officers as of the License Agreement Effective Date.

 

JUNO THERAPEUTICS, INC.     CELGENE CORPORATION
By:  

 

    By:  

 

Name:  

 

    Name:  

 

Title:  

 

    Title:  

 

      CELGENE RIVOT LTD.
     

By:

     

Name:

     

Title:

[Signature page to License Agreement]

 


EXHIBIT A

Licensed Program

The Program that is the subject of this License Agreement (the “ Licensed Program ”) is:

 

  ¨ the CD19 Program

 

  ¨ the CD22 Program

 

  ¨ an Other Juno Program [ List which ]:                    

 

A - 1


EXHIBIT B

Licensed Target, Licensed Candidates and [***]

If the Licensed Program is:

 

  ¨ the CD19 Program, then:

 

  A. the “ Licensed Target ” is: CD19.

 

  B. the “ Licensed Candidates ” are: (i) JCAR015, (ii) JCAR014, (iii) JCAR017, (iv) JCAR021, and (v) each [***] [***] within a [***] for the Licensed Target and that is [***] either Party or any of its Affiliates prior to or after the License Agreement Effective Date [***]. For clarity, and as set forth in Section 1.109 of the Master Collaboration Agreement, Licensed Candidates also include [***], and which may be [***].

 

  C. the [***] are: [ provide list ]

 

  ¨ the CD22 Program, then:

 

  A. the “ Licensed Target ” is: CD22.

 

  B. the “ Licensed Candidates ” are: (i) JCAR018 and (ii) each [***]that is included in the [***] for the Licensed Target and is [***] either Party or any of its Affiliates prior to or after the License Agreement Effective Date until [***]. For clarity, and as set forth in Section 1.109 of the Master Collaboration Agreement, Licensed Candidates also include [***], and which may be [***].

 

  C. the [***] are: [ List ]

¨ an Other Juno Program (including any [***] Program included within this License Agreement pursuant to Section 2.9). [ List which ]:                      , then:

 

  A. the “ Licensed Target ” is [                      ]

 

  B. the “ Licensed Candidates ” are each [***]included in the [***] for the Licensed Target that is [***] that is included in the [***] for such Licensed Target and is [***] either Party or any of its Affiliates prior to or after the License Agreement Effective Date until [***]. For clarity, and as set forth in Section 1.109 of the Master Collaboration Agreement, Licensed Candidates also include [***], and which may be [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

B - 1


  C. the [***] are: [ List ]

¨ For clarity, for each of the foregoing Licensed Programs, in no event shall any Target of an Excluded Program be a Licensed Target.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

B - 2


EXHIBIT C-1

Financial Terms – CD19 Program

In consideration for the rights and licenses granted to Celgene under this License Agreement with respect to the Licensed Program (where such Licensed Program is the CD19 Program):

 

1. Upfront Fee . Celgene shall, within [***] after delivery to Juno of the Celgene Option Exercise Notice for the CD19 Program, pay to Juno an Option exercise fee in an amount equal to [***] or [***], as set forth in Section 6.3.1 of the Master Collaboration Agreement.

 

2. Royalties for Licensed Products (and not Licensed Diagnostic Products).

(a) Subject to Paragraph 2(b), and Article 5 of this License Agreement, on a Licensed Product-by-Licensed Product basis, Celgene shall pay Juno royalties on License Net Sales by Celgene, its Affiliates and Sublicensees in the ROW Territory, for the applicable Licensed Product at the royalty rates set forth below:

 

License Net Sales in the ROW Territory of CD19 Product (For each Licensed Product)

   Royalty
Rate

On all License Net Sales of such Licensed Product in the ROW Territory by Celgene, its Affiliates and Sublicensees

   [***]

(b) Notwithstanding the foregoing, if (i) the Licensed Product [***] for which Celgene exercised its Option pursuant to Section 3.1.5 of the Master Collaboration Agreement after the License Agreement Effective Date, and (ii) [***], then the royalty rate applicable to sales of such Licensed Product [***] at the time Celgene exercised its Option pursuant to Section 3.1.5 of the Master Collaboration Agreement.

(c) For clarity, the royalties set forth in this Paragraph 2 of this Exhibit C-1 do not apply to Licensed Diagnostic Products, which royalties are set forth solely in Paragraph 3 of this Exhibit C-1 .

 

3.

Royalties for Licensed Diagnostic Products . On a Licensed Diagnostic Product-by-Licensed Diagnostic Product basis, Celgene shall pay Juno royalties on License Net Sales by Celgene, its Affiliates and Sublicensees in the ROW Territory, of any Licensed Diagnostic Product sold [***] Licensed Product

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

C-1 - 1


  that is [***] at the royalty rate set forth below; provided, that if such Licensed Diagnostic Product is sold by Celgene, its Affiliate or Sublicensee for [***] (as defined in the Form of Co-Development and Co-Commercialization Agreement attached to the Master Collaboration Agreement as Exhibit B) [***], then the royalty rate shall be [***].

 

License Net Sales in the ROW Territory of Licensed Diagnostic Product (For each Licensed Product)

   Royalty
Rate

On all License Net Sales of such Licensed Diagnostic Product in the ROW Territory by Celgene, its Affiliates and Sublicensees

   [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

C-1 - 2


EXHIBIT C-2

Financial Terms – CD22 Program

In consideration for the rights and licenses granted to Celgene under this License Agreement with respect to the Licensed Program (where such Licensed Program is the CD22 Program):

 

1. Upfront Fee . Celgene shall, within [***] after delivery to Juno of the Celgene Option Exercise Notice for the CD22 Program, pay to Juno an Option exercise fee in an amount equal to [***] or [***], as set forth in Section 6.3.2 of the Master Collaboration Agreement;

 

2. Royalties for Licensed Products (and not Licensed Diagnostic Products).

(a) Subject to Article 5 of this License Agreement, on a Licensed Product-by-Licensed Product basis, Celgene shall pay Juno royalties on License Net Sales by Celgene, its Affiliates and Sublicensees in the ROW Territory, for the applicable Licensed Product at the royalty rates set forth below:

 

License Net Sales in the ROW Territory of CD22 Product (For each Licensed Product)

   Royalty
Rate

On all License Net Sales of such Licensed Product in the ROW Territory by Celgene, its Affiliates and Sublicensees

   [***]

(b) Notwithstanding the foregoing, if (i) the Licensed Product contains an [***] that is [***] to CD22 that is included in an [***] in an [***] for which Celgene exercised its Option pursuant to Section 3.1.5 of the Master Collaboration Agreement after the License Agreement Effective Date, and (ii) [***], then the royalty rate applicable to sales of such Licensed Product [***] at the time Celgene exercised its Option pursuant to Section 3.1.5 of the Master Collaboration Agreement.

(c) For clarity, the royalties set forth in this Paragraph 2 of this Exhibit C-2 do not apply to Licensed Diagnostic Products, which royalties are set forth solely in Paragraph 3 of this Exhibit C-2 .

 

3. Royalties for Licensed Diagnostic Products . On a Licensed Diagnostic Product-by-Licensed Diagnostic Product basis, Celgene shall pay Juno royalties on License Net Sales by Celgene, its Affiliates and Sublicensees in the ROW Territory, of any Licensed Diagnostic Product sold [***] such Licensed Product that is [***] at the royalty rate set forth below; provided, that if such Licensed Diagnostic Product is sold by Celgene, its Affiliate or Sublicensee for [***] (as defined in the Form of Co-Development and Co-Commercialization Agreement attached to the Master Collaboration Agreement as Exhibit B) [***], then the royalty rate shall be [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

C-2 - 1


License Net Sales in the ROW Territory of Licensed Diagnostic Product (For each Licensed Product)

   Royalty
Rate

On all License Net Sales of such Licensed Diagnostic Product in the ROW Territory by Celgene, its Affiliates and Sublicensees

   [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

C-2 - 2


EXHIBIT C-3

Financial Terms – Other Juno Program and [***] Programs

In consideration for the rights and licenses granted to Celgene under this License Agreement with respect to the Licensed Program where such Licensed Program is an Other Juno Program or an [***] Program (and is not the CD19 Program or the CD22 Program):

 

1. Option Exercise and Designation Payments.

(a) If the Licensed Program is an Other Juno Program, Celgene shall pay the Designation Payment to Celgene under Payment Structure A at the time it exercises the Option for such Other Juno Program. Accordingly, Celgene shall pay, within [***] following the delivery of the Option Exercise Notice for such Other Juno Program pursuant to Section 3.1.3(a) of the Master Collaboration Agreement, the Designation Payment in an amount calculated in accordance with Section 6.4.2 of the Master Collaboration Agreement, pursuant to Payment Structure A.

(b) If the Licensed Program is an [***] Program for which Celgene exercised its Option pursuant to Section 3.1.5 of the Master Collaboration Agreement, then Celgene shall pay, within [***] following the delivery of the [***] Option Exercise Notice for such [***] Program pursuant to Section 3.1.3(a) of the Master Collaboration Agreement, the Designation Payment in an amount calculated in accordance with Section 6.4.2 of the Master Collaboration Agreement, pursuant to Payment Structure A.

 

2. Royalties for Licensed Products (and not Licensed Diagnostic Products).

(c) Subject to Paragraph 3(b) and Article 5 of this License Agreement, on a Licensed Product-by-Licensed Product basis, Celgene shall pay Juno royalties on License Net Sales by Celgene, its Affiliates and Sublicensees in the ROW Territory, for the applicable Licensed Product at the royalty rates set forth below:

 

Data Package Submitted at which Option Exercise by Celgene Occurred for Licensed Program

   Royalty Rate

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

(d) Notwithstanding the foregoing, if (i) the Licensed Product contains [***] pursuant to Section 3.1.5 of the Master Collaboration Agreement after the License Agreement Effective Date, and (ii) such [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

C-3 - 1


[***], then the royalty rate applicable to sales of such Licensed Product in the chart above shall [***] (A) [***] the License Agreement Effective Date, and (B) [***] at the time Celgene exercised its Option pursuant to Section 3.1.5 of the Master Collaboration Agreement.

(e) For clarity, the royalties set forth in this Paragraph 2 of this Exhibit C-3 do not apply to Licensed Diagnostic Products, which royalties are set forth solely in Paragraph 3 of this Exhibit C-3 .

 

3. Royalties for Licensed Diagnostic Products . On a Licensed Diagnostic Product-by-Licensed Diagnostic Product basis, Celgene shall pay Juno royalties on License Net Sales by Celgene, its Affiliates and Sublicensees in the ROW Territory, of any Licensed Diagnostic Product sold for use [***] such Licensed Product that is [***] at the royalty rate set forth below; provided, that if such Licensed Diagnostic Product is sold by Celgene, its Affiliate or Sublicensee for [***] (as defined in the Form of Co-Development and Co-Commercialization Agreement attached to the Master Collaboration Agreement as Exhibit B) [***], then the royalty rate shall be [***].

 

License Net Sales in the ROW Territory of Licensed Diagnostic Product(For each Licensed Product)

   Royalty
Rate

On all License Net Sales of such Licensed Diagnostic Product in the ROW Territory by Celgene, its Affiliates and Sublicensees

   [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

C-3 - 2


EXHIBIT D

Press Release

[To be drafted and attached at time of execution of this License Agreement]

 

D - 1


EXHIBIT E

Form of License Material Transfer Agreement

This License Material Transfer Agreement No.              (the “ License Material Transfer Agreement ”) is made as of                      (the “ License Material Transfer Agreement Effective Date ”), pursuant to that certain License Agreement for the [ List Program ] Program, entered into by Juno Therapeutics, Inc., Celgene Corporation and Celgene RIVOT Ltd., with an effective date of [●], 20      (the “ [ List Program ] Program License Agreement ”), by and between:

Transferring Party: [ Please identify transferring party ]

And

License Material Receiving Party: [ Please identify receiving party ]

for the transfer of:

 

A. Confidential Information :

[ Please identify any Confidential Information other than License Materials that would be transferred, e.g., assay protocols. If none, state “None.” ]

 

B. License Materials :

[ Please identify all License Materials to be transferred by type and name, as well as specifying the amount transferred. If none, state “None.” ]

for the following Program(s):

 

         ¨   CD19 Program

 

         ¨   CD22 Program

 

         ¨   other Program. [ List which ]:                                                                                           

and for the purpose of:

[ Please describe purpose and scope of use of such Confidential Information and/or License Materials ]

The Parties acknowledge and agree that the transfer of Confidential Information and/or License Materials pursuant to this License Material Transfer Agreement will be pursuant to and in accordance with the terms and conditions of the Master Collaboration Agreement and this [ list

 

E - 1


Program ] License Agreement. Any capitalized terms used in this License Material Transfer Agreement that are not defined herein have the meanings ascribed to them in the Master Collaboration Agreement or the [ list Program ] License Agreement, as applicable.

[ Signature Page Follows ]

 

E - 2


IN WITNESS WHEREOF, this License Material Transfer Agreement is entered into as of the License Material Transfer Agreement Effective Date, and it is accepted and agreed to by the Parties’ authorized representatives.

 

For the Transferring Party:    For the License Materials Receiving Party:

By:

       By:    

Name:

       Name:    

Title:

       Title:    

 

E - 3


EXHIBIT F

Commercialization Opt-In Terms

If the Commercialization Opt-In Right is exercised by Juno pursuant to Section 3.3.1, or by Celgene pursuant to Section 3.3.2, the Party exercising such Commercialization Opt-In Right shall have the right to participate in the following activities relating to the Commercialization of Licensed Products (the “ Commercialization Opt-In Activities ”) in the Major EU Market Countries (where Juno is the Party exercising the Commercialization Opt-In Right), or the North America Territory (where Celgene is the Party exercising the Commercialization Opt-In Right, and in such case the following terms shall apply to the conduct of the Commercialization Activities:

1.1 Commercialization Lead Party Responsibilities . Following the exercise of the Commercialization Opt-In Right, the Commercialization Lead Party shall remain responsible for:

(a) the form and content of the License Commercialization Plan for Commercialization of Licensed Products in the ROW Territory (where Celgene is the Commercialization Lead Party) and outside the ROW Territory (where Juno is the Commercialization Lead Party), [***], in accordance with Section 3.4.2, and for all activities relating to the Commercialization of Licensed Product in the Territory, except as expressly set forth in Section 1.2 of this Exhibit F below;

(b) booking all sales of Licensed Products in the relevant territory;

(c) execution of medical and scientific affairs and programs, including professional symposia and other educational activities, and medical affairs studies based upon approved protocols, including medical information support and medical communications and publishing activities;

(d) [***]; and

(e) all market access activities, including wholesaler and distributor management, local contracting and pricing, payor relations and patient support programs, including the designation of any personnel for any of the foregoing in the relevant territory.

1.2 Commercialization Opt-In Activities . The Party opting-in shall have the right to participate in certain Commercialization Opt-In Activities relating to the Licensed Product as follows:

(a) Training; Details . The Commercialization Lead Party will, for the countries for which it serves as Commercialization Lead Party, (i) [***] with respect to Licensed Products, and [***] for such sales representatives therefor, and (ii) [***]. The Party opting-in to Commercialization Opt-In Activities will [***].

(b) Sales Representatives; Detailing . The Parties will discuss and agree upon the exact number of sales representatives that may be allocated to the Party opting-in to

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

F-1


Commercialization Opt-In Activities to promote and detail the Licensed Products in the ROW Territory (if Juno opted in), or outside the ROW Territory (if Celgene opted in), provided that the Party opting-in to Commercialization Opt-In Activities will have the right to provide (i) [***], or (ii) [***]. The Party opting-in to Commercialization Opt-In Activities will be [***]. Each Party will be responsible for the activities of its sales representatives, including compliance by its sales representatives with training and detailing requirements. Notwithstanding the foregoing, the Party opting-in to Commercialization Opt-In Activities [***] such Licensed Product in accordance with the terms of this License Agreement and applicable Law in the relevant countries. If the Commercialization Lead Party raises [***] with the Party opting-in to Commercialization Opt-In Activities regarding [***], such other Party will [***].

(c) Promotional Materials . The sales representatives assigned to promote the Licensed Product by the Party opting-in to Commercialization Opt-In Activities will utilize only promotional materials that have been approved by the Commercialization Lead Party and in accordance with the License Commercialization Plan for the relevant Licensed Product in the relevant country. All detailing activities conducted by the opting-in Party’s sales representatives will be consistent in all material respects with the promotional materials so approved for the relevant Licensed Product in the relevant country. The opting-in Party will train and instruct its sales representatives to make only those statements and claims regarding the Licensed Product, including as to efficacy and safety, that are consistent with the Licensed Product labeling and accompanying inserts and the approved promotional materials. For clarity, all marketing and promotional materials must be approved by the Commercialization Lead Party prior to use.

(d) Reporting . The opting-in Party will provide the Commercialization Lead Party with a report, as soon as practicable but in no event later than [***] following the end of each Calendar Quarter commencing as of and after the first Licensed

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

F-2


Product has received Regulatory Approval from the EMA or the FDA, as applicable, or at such other time as the JCC deems appropriate, and for the remainder of the License Term for such Licensed Product, setting forth the number of details made by its sales representatives of Licensed Product in the Major EU Market Countries during such Calendar Quarter. [***].

(e) Records . The opting-in Party will maintain records and otherwise establish procedures to ensure compliance with all applicable Laws and professional requirements that apply to the promotion and marketing of Licensed Product, including compliance with the PhRMA Code on Interactions with Healthcare Professionals.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

F-3


SCHEDULE 6.1.1

Patents Licensed to Celgene


SCHEDULE 6.1.2

Patents Licensed to Juno


EXHIBIT B

FORM OF J LEAD CO-CO AGREEMENT

JUNO LEAD CO-DEVELOPMENT AND CO-COMMERCIALIZATION AGREEMENT

by and among

[                    ]

and

[                             ]

and

[                                     ]

Dated as of [ ], [ ]


TABLE OF CONTENTS

 

          Page  

ARTICLE 1 DEFINITIONS

     2   

1.1

   “Celgene Relevant Co-Co IP”      2   

1.2

   “Celgene Territory Administration”      2   

1.3

   “Juno Co-Co Regulatory-Based Exclusivity”      2   

1.4

   “First Juno Program Co-Co Sale”      3   

1.5

   “Juno Co-Co Annual Net Sales”      3   

1.6

   “Juno Co-Co Commercialization Opt-In Terms”      3   

1.7

   “Juno Co-Co Commercialization Plan”      3   

1.8

   “Juno Co-Co Development Budget”      3   

1.9

   “Juno Co-Co Development Plan”      3   

1.10

   “Juno Co-Co Lead Party”      4   

1.11

   “Juno Co-Co Net Sales”      4   

1.12

   “[***]”      5   

1.13

   “Juno Program Co-Co Combination Product”      5   

1.14

   “Juno Program Co-Co IP”      5   

1.15

   “Juno Program Co-Co Product Data”      5   

1.16

   “Juno Territory Administration”      5   

1.17

   Additional Definitions.      5   

1.18

   Definitions from Master Collaboration Agreement.      7   

ARTICLE 2 DEVELOPMENT, REGULATORY AND SUPPLY

     10   

2.1

   Juno Co-Co Program, Juno Program Co-Co Target and Candidates.      10   

2.2

   Development.      10   

2.3

   Regulatory.      16   

2.4

   Manufacturing and Supply.      21   

2.5

   Records; Reports; Results.      21   

2.6

   Materials Transfer; License.      21   

2.7

   No Representation      23   

2.8

   Covenant During Juno Co-Co Term      23   

ARTICLE 3 COMMERCIALIZATION; RIGHT TO OPT IN

     23   

3.1

   Commercialization.      23   

3.2

   Additional Terms      29   

ARTICLE 4 EXCLUSIVITY

     30   

4.1

   Exclusivity.      30   

ARTICLE 5 FINANCIAL TERMS

     30   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


          Page  

5.1

   Option Exercise and Designation Payments      30   

5.2

   Profit & Loss Share for Juno Program Co-Co Product      31   

5.3

   Discounted Sales.      31   

5.4

   Additional Payment Terms      31   

ARTICLE 6 INTELLECTUAL PROPERTY

     32   

6.1

   License      32   

6.2

   Ownership      34   

6.3

   Prosecution and Maintenance of Patents      34   

6.4

   Defense of Claims Brought by Third Parties      35   

6.5

   Enforcement of Patents      35   

6.6

   Patent Term Extensions      39   

6.7

   [***]      41   

6.8

   [***] Patents      41   

6.9

   Regulatory Data Protection      41   

6.10

   Third Party Licenses      41   

ARTICLE 7 UPSTREAM AGREEMENTS

     41   

7.1

   Upstream Obligations      41   

ARTICLE 8 INDEMNIFICATION; INSURANCE

     41   

8.1

   Indemnification by Celgene      41   

8.2

   Indemnification by Juno      42   

8.3

   Notice of Claims      42   

8.4

   Indemnification Procedures      42   

8.5

   Juno Co-Co Program Administration Liabilities      43   

8.6

   LIMITATION OF LIABILITY      44   

ARTICLE 9 JUNO CO-CO TERM AND TERMINATION

     44   

9.1

   Juno Co-Co Term; Expiration      44   

9.2

   Termination Without Cause.      44   

9.3

   Termination for Breach      45   

9.4

   Termination for Patent Challenges      46   

9.5

   Termination for Bankruptcy      47   

9.6

   Termination for Breach of Standstill.      47   

9.7

   Effects of Expiration or Termination      47   

9.8

   Juno Program Co-Co Reversion Products      48   

9.9

   Survival of Sublicensees      50   

9.10

   Surviving Provisions      50   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-ii-


          Page  

9.11

   Relationship to Other Agreements      51   

ARTICLE 10 MISCELLANEOUS

     51   

10.1

   Confidentiality; Publicity      51   

10.2

   Disclaimer of Warranties      51   

10.3

   Applicability of Terms of Master Collaboration Agreement      52   

10.4

   Assignment      52   

10.5

   Entire Agreement      53   

 

-iii-


LIST OF EXHIBITS

 

Exhibit A    Juno Co-Co Program
Exhibit B    Juno Program Co-Co Target, Juno Program Co-Co Candidates and
   [***]
Exhibit C    Co-Co Upfront Payments
Exhibit D    Profit & Loss Share
Exhibit E    Form of Juno Co-Co Material Transfer Agreement
Exhibit F    Juno Co-Co Commercialization Opt-In Terms
Exhibit G    Form of Press Release
Exhibit H    Certain U.S. Federal Income Tax Matters

LIST OF SCHEDULES

 

Schedule 3.1.7(b)    Minimum Sales Representative Qualifications
Schedule 6.1.1    Patents Licensed to Celgene
Schedule 6.1.2    Patents Licensed to Juno

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-iv-


JUNO LEAD CO-CO AGREEMENT

This JUNO LEAD CO-DEVELOPMENT AND CO-COMMERCIALIZATION AGREEMENT (this “ Juno Lead Co-Co Agreement ”) is entered into and made effective as of [●], 20      (the “ Juno Lead Co-Co Agreement Effective Date ”) by and among Juno Therapeutics, Inc. , a Delaware corporation (“ Juno ”), and Celgene Corporation , a Delaware corporation (“ Celgene Corp. ”), with respect to all rights and obligations under this Juno Lead Co-Co Agreement in the United States, and Celgene RIVOT Ltd. (“ Celgene RIVOT ”), with respect to all rights and obligations under this Juno Lead Co-Co Agreement outside of the United States (Celgene RIVOT and Celgene Corp. together, “ Celgene ”). Celgene and Juno are each referred to herein as a “ Party ” or, collectively, as the “ Parties .”

RECITALS

WHEREAS , Juno and Celgene entered into that certain Master Research and Collaboration Agreement, dated as of [              ], 2015 (as amended, the “ Master Collaboration Agreement ”), pursuant to which Celgene has an exclusive option to obtain an certain rights to participate in the development and commercialization in the ROW Territory (as defined in the Master Collaboration Agreement) of Development Candidates and Products arising out of activities conducted pursuant to certain Juno Programs, Eligible BD Programs and [***] Programs (each such program as defined in the Master Collaboration Agreement) and to share profits and losses arising from the development and commercialization of such Development Candidates and Products on a worldwide basis;

WHEREAS , pursuant to the terms of the Master Collaboration Agreement, upon exercise by Celgene of (a) the BD Option with respect to an Eligible BD Program for which Juno is the BD Acquiring Party pursuant to Section 2.2.1 of the Master Collaboration Agreement, (b) the Celgene Co-Promote Right with respect to a Juno Program or [***] Program for which Celgene exercised an Option pursuant to Section 3.1.4 of the Master Collaboration Agreement, or (c) the [***] Option for an [***] BD Program offered by Juno to the Collaboration pursuant to Section 3.1.5 of the Master Collaboration Agreement (as each term is defined in the Master Collaboration Agreement), or by Juno of the BD Option for a [***] BD Program for which Celgene is the BD Acquiring Party pursuant to Section 2.2.1 of the Master Collaboration Agreement, the Parties are obligated to enter into this Juno Lead Co-Co Agreement within a period of time specified in the Master Collaboration Agreement; and

WHEREAS , Celgene has delivered either (a) a BD Option Exercise Notice pursuant to Section 2.2.1(a) of the Master Collaboration Agreement, or (b) a Celgene Option Exercise Notice pursuant to Section 3.1.3(b) of the Master Collaboration Agreement, or an [***] Option Exercise Notice pursuant to Section 3.1.5(d) of the Master Collaboration Agreement, and in the case of (b), Celgene has also exercised the Celgene Co-Promote Right for such Juno Co-Co Program pursuant to Section 3.1.4 of the Master Collaboration Agreement or Section 3.2.2 of a License Agreement, or Juno has delivered a BD Option Exercise Notice for a [***] BD Program for which Celgene was the BD Acquiring Party, and accordingly, Celgene and Juno are obligated to enter into this Juno Lead Co-Co Agreement with respect thereto;

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


WHEREAS, pursuant to this Juno Lead Co-Co Agreement, Juno grants to Celgene exclusive rights in the ROW Territory with respect to the development, manufacture and commercialization of Co-Co Candidates (as defined in the Master Collaboration Agreement) for such Juno Co-Co Program, (the “ Juno Program Co-Co Candidates ”) and Co-Co Products (as defined in the Master Collaboration Agreement) for such Juno Co-Co Program (the “ Juno Program Co-Co Products ”) and Celgene grants to Juno exclusive rights outside the ROW Territory with respect to the development, manufacture and commercialization of the Juno Program Co-Co Candidates and Juno Program Co-Co Products, on the terms and subject to the conditions set forth herein.

NOW, THEREFORE , in consideration of the foregoing and the mutual agreements set forth below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

ARTICLE 1

DEFINITIONS

Capitalized terms used, but not defined, herein will have the meanings ascribed to them in the Master Collaboration Agreement.

1.1 “Celgene Relevant Co-Co IP” means, with respect to the Juno Co-Co Program, all Celgene IP Controlled by Celgene and/or its Affiliates as of the Juno Lead Co-Co Agreement Effective Date or at any time thereafter during the Juno Co-Co Term that (i) [***] (1) Juno Program Co-Co Candidates, (2) Juno Program Co-Co Products and/or (3) Juno Program Co-Co Diagnostic Products or (ii) [***], including in each case any such [***], and in each case subject to the following sentence. Notwithstanding anything to the contrary in this Section 1.1, Patents included in the Celgene Relevant Co-Co IP shall not include (A) any Patents to the extent such Patents [***], or (B) any Patents to the extent such Patents [***].

1.2 “Celgene Territory Administration” means administration of Juno Program Co-Co Products to a patient when such patient is located in the ROW Territory.

1.3 “Juno Co-Co Regulatory-Based Exclusivity” means, on a Juno Program Co-Co Product-by-Juno Program Co-Co Product and country-by-country basis, that (a) Juno or any of its Affiliates or Sublicensees has been granted the exclusive legal right by a Regulatory Authority (or is otherwise entitled to the exclusive legal right by operation of Law) in such country to market and sell the Juno Program Co-Co Product or the active ingredient comprising such Juno Program Co-Co Product in such country, or (b) the data and information submitted by Juno or any of its Affiliates or Sublicensees to the relevant Regulatory Authority in such country for purposes of obtaining Regulatory Approval for such Juno Program Co-Co Product may not be disclosed, referenced or relied upon in any way by any Person to support the Regulatory Approval or marketing of any product by a Third Party in such country other than (i) Juno, its Affiliates or Sublicensees, or (ii) solely to the extent permitted in this Juno Lead Co-Co Agreement, Celgene, its Affiliates or Sublicensees (including in each case by relying upon the Regulatory Authority’s previous findings regarding the safety or effectiveness of the Juno Program Co-Co Product).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2


1.4 “First Juno Program Co-Co Sale” means, on a Juno Program Co-Co Product-by-Juno Program Co-Co Product and Juno Program Co-Co Diagnostic Product-by-Juno Program Co-Co Diagnostic Product basis, the first sale [***] by Celgene or its Affiliates or Sublicensees for use or consumption by [***] of such Juno Program Co-Co Product (or Juno Program Co-Co Diagnostic Product, as applicable) in a country for which [***] Regulatory Approvals [***] in order to sell such Juno Program Co-Co Product (or Juno Program Co-Co Diagnostic Product, as applicable) in [***] have been granted; in each case, provided, however, that the following shall not constitute a First Juno Program Co-Co Sale: (a) any sale to an Affiliate or Sublicensee of a Party unless the Affiliate or Sublicensee is the last entity in the distribution chain of the Juno Program Co-Co Product (or Juno Program Co-Co Diagnostic Product, as applicable); (b) any use of such Juno Program Co-Co Product or Juno Program Co-Co Diagnostic Product in Clinical Trials, non-clinical development activities or other development activities with respect to such Juno Program Co-Co Product or Juno Program Co-Co Diagnostic Product by or on behalf of a Party, or disposal or transfer of such Juno Program Co-Co Product or Juno Program Co-Co Diagnostic Product for a bona fide charitable purpose; and (c) compassionate use, in each case for which no payment is received by a Party, its Affiliates or Sublicensees.

1.5 “Juno Co-Co Annual Net Sales” means, on a Juno Program Co-Co Product-by-Juno Program Co-Co Product and Juno Program Co-Co Diagnostic Product-by-Juno Program Co-Co Diagnostic Product basis, total Juno Co-Co Net Sales by Juno, its Affiliates and Sublicensees in the Territory of such Juno Program Co-Co Product or Juno Program Co-Co Diagnostic Products in a particular [***].

1.6 “Juno Co-Co Commercialization Opt-In Terms” means the additional terms of participation by a Party in Commercialization Activities relating to Juno Program Co-Co Product following (a) exercise of the Commercialization Opt-In Right by Juno pursuant to Sections 3.1.3 (by Juno with respect to the Major EU Market Countries), or (b) delivery by Celgene of a Celgene Co-Commercialization Notice pursuant to Section 3.1.2 with respect to the North America Territory, as set forth on Exhibit F .

1.7 “Juno Co-Co Commercialization Plan” means the plan that specifies the Parties’ responsibilities for the Commercialization of Juno Program Co-Co Product for Juno Territory Administration and Celgene Territory Administration during a given Calendar Year and the [***] succeeding Calendar Years.

1.8 “Juno Co-Co Development Budget” means, on a Juno Program Co-Co Product-by-Juno Program Co-Co Product basis, the budget for conducting Development of such Juno Program Co-Co Product (and corresponding Juno Program Co-Co Candidates and if applicable Juno Program Co-Co Diagnostic Products) in the Territory, pursuant to the Juno Co-Co Development Plan, during a given Calendar Year and [***] succeeding Calendar Years, as prepared in part by Celgene (for Juno Program Co-Co Product for Celgene Territory Administration) and in part by Juno (for Juno Program Co-Co Product for Juno Territory Administration) and approved by the JRDC in accordance with Section 2.2.8.

1.9 “Juno Co-Co Development Plan” means, on a Juno Program Co-Co Product-by-

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

3


Juno Program Co-Co Product basis, the plan for the Development of such Juno Program Co-Co Product (and corresponding Juno Program Co-Co Candidates and if applicable Juno Program Co-Co Diagnostic Products) in the Territory during a given Calendar Year and the [***] succeeding Calendar Years, as prepared by Celgene (for Juno Program Co-Co Product for Celgene Territory Administration) and by Juno (for Juno Program Co-Co Product for Juno Territory Administration) and approved by the JRDC in accordance with Section 2.2.4.

1.10 “Juno Co-Co Lead Party” means, for the ROW Territory, Celgene, and outside of the ROW Territory, Juno.

1.11 “Juno Co-Co Net Sales” means, with respect to any Juno Program Co-Co Product or Juno Program Co-Co Diagnostic Products, the [***] amounts [***] by Juno, its Affiliates and Sublicensees (each, a “ Juno Co-Co Selling Party ”) to Third Party customers for sales of such Juno Program Co-Co Product or Juno Program Co-Co Diagnostic Product, less the following deductions [***] in accordance with (as applicable to the Juno Co-Co Selling Party) the Accounting Principles, for:

(a) [***];

(b) [***];

(c) [***];

(d) [***];

(e) [***]; and

(f) [***].

If non-monetary consideration is received by a Juno Co-Co Selling Party for any Juno Program Co-Co Product or Juno Program Co-Co Diagnostic Product in the relevant country, Juno Co-Co Net Sales will be calculated based on the [***]. Notwithstanding the foregoing, Juno Co-Co Net Sales shall not be imputed to transfers of Juno Program Co-Co Products or Juno Program Co-Co Diagnostic Products, as applicable, for use in [***].

Juno Co-Co Net Sales shall be determined on, and only on, the first sale by Juno or any of its Affiliates or Sublicensees to a non-Sublicensee Third Party.

If a Juno Program Co-Co Product is sold as part of a Juno Program Co-Co Combination Product, Juno Co-Co Net Sales will be the product of (i) Juno Co-Co Net Sales of the Juno Program Co-Co Combination Product calculated as above (i.e., calculated as for a non-Juno Program Co-Co Combination Product) and (ii) the fraction [***], where:

[***]

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

4


[***]

1.12 “[***]” means, [***].

1.13 “Juno Program Co-Co Combination Product” means any Juno Program Co-Co Product comprising a Juno Co-Co Development Candidate and one or more other active ingredient(s) that is not itself a Juno Program Co-Co Candidate (such other active ingredients, “ Other Actives ”). For clarification, the term “Other Active,” when referring to an ingredient included in such Juno Program Co-Co Product refers to ingredients that are incorporated or included in the Juno Program Co-Co Product for [***] (whether in the same or different formulations, or dosed separately or together) for the purpose of [***]; the term excludes such ingredients that are present in such a Juno Program Co-Co Product [***].

1.14 “Juno Program Co-Co IP” means, with respect to the Juno Co-Co Program, all Juno IP Controlled by Juno and/or its Affiliates as of the Juno Lead Co-Co Agreement Effective Date or at any time thereafter during the Juno Co-Co Term that (i) [***] or (ii) [***] (1) Juno Program Co-Co Candidate, (2) Juno Program Co-Co Product and/or (3) Diagnostic Products for such Juno Program Co-Co Candidates or Juno Program Co-Co Products (such Diagnostic Products, the “ Juno Program Co-Co Diagnostic Products ”), including in each case any such [***], and in each case subject to the following sentence. Notwithstanding anything to the contrary in this Section 1.14, Patents included in the Juno Program Co-Co IP shall not include (A) any Patents to the extent such Patents [***], or (B) any Patents to the extent such Patents [***].

1.15 “Juno Program Co-Co Product Data” means all relevant data included in the Know-How Controlled by either Party or its Affiliates in relation to the Juno Program Co-Co Products for use in the Field that: (a) is in existence at the Co-Co Agreement Effective Date; (b) is generated from [***] for Juno Program Co-Co Products or Juno Program Co-Co Diagnostic Products in the Field; or (c) [***] the Juno Program Co-Co Products or Juno Program Co-Co Diagnostic Products in the Field.

1.16 “Juno Territory Administration” means administration of Juno Program Co-Co Product to a patient when such patient is located outside of the ROW Territory, excluding China.

1.17 Additional Definitions. Each of the following terms has the meaning described in the corresponding section of this Juno Lead Co-Co Agreement indicated below:

 

Defined Term:

   Section:

[***]

   2.2.5(b)(4)

Allocable Overhead

   Exhibit D

Allowable Expenses

   Exhibit D

[***]

   2.2.5(b)(3)

Celgene

   Preamble

Celgene Co-Commercialization Notice

   3.1.2(a)

Celgene Corp.

   Preamble

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

5


Defined Term:

   Section:

Celgene RIVOT

   Preamble

Cost of Goods Sold or COGS

   Exhibit D

Cure Period

   9.3.1

Distribution Costs

   Exhibit D

Gross Profit

   Exhibit D

Indemnification Claim

   8.3

Indemnitee

   8.3

Indemnitor

   8.3

[***]

   5.4.3(b)

Information Request

   3.1.7(d)

Juno

   Preamble

Juno Co-Co Additional Study

   2.2.5(b)

Juno Co-Co [***]

   2.2.5(b)(3)

Juno Co-Co Commercialization Budget

   3.1.8

Juno Co-Co Commercialization Plan

   3.1.6(b)

Juno Co-Co Commercialization Report

   3.2.3

Juno Co-Co [***]

   2.2.5(b)(3)

Juno Co-Co Development Costs

   Exhibit D

Juno Co-Co Material Transfer Agreement

   2.6.1

Juno Co-Co Material Transfer Agreement Effective Date

   Exhibit E

Juno Co-Co Materials

   2.6.1

Juno Co-Co Materials Receiving Party

   2.6.1

Juno Co-Co Product Administration

   8.5

Juno Co-Co Product Administration Liabilities

   8.5

Juno Co-Co Program

   Exhibit A

Juno Co-Co Program Assets

   2.8

Juno Co-Co Purpose

   2.6.1

Juno Co-Co Research Cost Allocation

   2.2.1

Juno Co-Co Selling Party

   1.11

Juno Co-Co Term

   9.1

Juno Co-Co Transferring Party

   2.6.1

Juno Lead Co-Co Agreement

   Preamble

Juno Lead Co-Co Agreement Effective Date

   Preamble

Juno Program Co-Co Buy In

   2.2.6

Juno Program Co-Co Candidates

   Recitals; Exhibit B

Juno Program Co-Co Competitive Infringement

   6.5.1

Juno Program Co-Co Covering Patent

   6.6.1

Juno Program Co-Co Diagnostic Products

   1.14

Juno Program Co-Co Enforcement Proceeding

   6.5.3

Juno Program Co-Co Product Patents

   6.5.2(a)

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

6


Defined Term:

   Section:

Juno Program Co-Co Products

   Recitals

Juno Program Co-Co Reversion Products

   9.8.1

Juno Program Co-Co Step-In Proceeding

   6.5.3

Juno Program Co-Co Target

   Exhibit B

[***]

   2.2.5(b)(3)

Manufacturing Costs

   Exhibit D

Marketing Costs

   Exhibit D

Master Collaboration Agreement

   Recitals

Non-Proposing Party

   2.2.5(b)(1)

North America Development Budget

   2.2.8(a)

Operating Profits or Losses

   Exhibit D

Other Actives

   1.13

Other Operating Income/Expenses

   Exhibit D

Package

   5.3

Party or Parties

   Preamble

Patent Term Extension

   6.6.1

Payee Party

   5.4.3(b)

Paying Party

   5.4.3(b)

Pharmacovigilance Agreement

   2.3.5(a)

Pharmacovigilance Expenses

   Exhibit D

Product Recall Expenses

   Exhibit D

Profit & Loss Share

   5.2

Proposing Party

   2.2.5(b)

Recording Party

   Exhibit D

Regulatory Expenses

   Exhibit D

Report

   Exhibit D

Research Cost Report

   2.2.8(c)

ROW Development Budget

   2.2.8(a)

Safety and CMC Data

   2.3.3(b)

Safety Reason

   9.2.2

Sales Costs

   Exhibit D

Sublicense Revenues

   Exhibit D

1.18 Definitions from Master Collaboration Agreement. Capitalized terms used herein but not defined, including each of the following terms, have the meaning described in the Master Collaboration Agreement:

 

Defined Term:

Accounting Principles

Affiliate

Antitrust Law

Bankruptcy Code

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

7


Defined Term:

BD Acquiring Party

BD Evaluation Period

BD Opt-In Payment

BD Option Exercise Notice

Biologics License Application or BLA

Business Combination

Business Day

Calendar Quarter

Calendar Year

CAR

[***] BD Program

Celgene Background IP

Celgene Co-Promote Program

Celgene Co-Promote Right

Celgene Indemnitees

Celgene IP

Celgene Option Exercise Notice

Celgene Patents

Celgene Platform Technology

Celgene Upstream Agreements

Cellular Therapy Products

Claims

Clinical Trial

CMC Activities

Co-Co Product

Collaboration IP

Commercialization

Commercialization Activities

Commercialization Lead Party

Commercialization Opt-In Right

Commercially Reasonable Efforts

Confidential Information

Control, Controls or Controlled

Core Dossier Studies

Cover, Covering or Covered

Damages

[***]

Development

Development & Commercialization Agreement

Development Candidate

Development Lead Party

Development Plan

Diagnostic Product

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

8


Defined Term:

Dollars or $

EMA

Equity Purchase Agreement

Executive Officers

FDA

Field

FTE Rate

Good Clinical Practices or GCP

Good Laboratory Practices or GLP

Good Manufacturing Practices or GMP

Hatch-Waxman Act

In Vivo Product

Immune Modulatory Agent or IMA

IND

Indication

Inventions

Joint Collaboration IP

JRDC

JSC

Juno Background IP

Juno Indemnitees

Juno IP

Juno Patents

Juno Platform Technology

Juno Program

Juno Program Assets

Juno Upstream Agreements

Know-How

Law or Laws

Litigation Conditions

MAA

Major EU Market Countries

Manufacture or Manufacturing

Manufacturing Agreement

New Drug Application or NDA

North America Territory

Offering Party

Option

Option Exercise Notice

Patent

Patent Committee

Person

Phase 3 Clinical Trial

 

9


Defined Term:

Phase 4 Clinical Trial

Post Option Costs

Product Liability

Products

Program

Prosecution and Maintenance

Regulatory Approval

Regulatory Authority

Regulatory Lead Party

Regulatory Materials

Reimbursable Costs

Research

Resulting Patents

ROW Territory

Small Molecule Compounds

Specifically Directed

Sublicensee

Target

Territory

Third Party

Third Party License

[***] BD Program

[***] Internal Program

[***] Option Exercise Notice

[***] Program

United States or U.S.

ARTICLE 2

DEVELOPMENT, REGULATORY AND SUPPLY

2.1 Juno Co-Co Program, Juno Program Co-Co Target and Candidates.

2.1.1 Juno Co-Co Program . The Juno Co-Co Program is the Program set forth on Exhibit A .

2.1.2 Juno Program Co-Co Target . The Juno Program Co-Co Target is set forth on Exhibit B .

2.1.3 Juno Program Co-Co Candidates . The Juno Program Co-Co Candidates, as of the Juno Lead Co-Co Agreement Effective Date, are set forth on Exhibit B .

2.1.4 [***]. The [***] under this Juno Lead Co-Co Agreement are set forth on Exhibit B , as such [***] may be amended from time to time.

2.2 Development.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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2.2.1 Roles and Responsibility . As of and after the Juno Lead Co-Co Agreement Effective Date, except as set forth in Sections 2.2.5, 3.2.1 and 3.2.2, and subject to Sections 2.2.7 and 2.3, Juno will be the Development Lead Party for Juno Program Co-Co Products for Juno Territory Administration, and will have sole responsibility for, and control of, Development of Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products in the Field outside of the ROW Territory and for Juno Territory Administration, and Celgene will be the Development Lead Party for Juno Program Co-Co Products for Celgene Territory Administration, and will have sole responsibility for, and control of the Development of Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products in the Field in the ROW Territory and for Celgene Territory Administration. Within [***] following the Juno Lead Co-Co Agreement Effective Date, the Parties shall convene a meeting of the JRDC to discuss their respective portions of the Juno Co-Co Development Plan for the Juno Co-Co Program, and to transition responsibility to Celgene for the conduct of Development and regulatory activities (including pursuant to Section 2.3) with respect to Juno Program Co-Co Candidates and Juno Program Co-Co Products for Celgene Territory Administration. Without limiting the foregoing, within [***] following the Juno Lead Co-Co Agreement Effective Date, the JRDC shall discuss and define the scope of Research activities that are to be conducted by the Parties in relation to the Juno Program Co-Co Candidates and Juno Program Co-Co Products in each case falling within [***] for the Juno Co-Co Program following the Juno Lead Co-Co Agreement Effective Date, and related budgets therefor. All such Research activities and the allocation of responsibility therefor between the Parties shall be set forth in the Juno Co-Co Development Plan. The costs of conducting Research activities in both the ROW Territory and the North America Territory in relation to the Juno Co-Co Program shall be reflected in a Research budget approved with the applicable Research plan.. The costs incurred by either Party in conducting Research activities shall be [***] (the “ Juno Co-Co Research Cost Allocation ”). Unless the Parties otherwise agree in writing, [***]. Decisions regarding Research will be [***].

2.2.2 Diligence . Celgene, directly or through one or more of its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to Develop and Commercialize Juno Program Co-Co Products in the Field for Celgene Territory Administration and otherwise to perform its obligations under the Juno Co-Co Development Plan. Juno, directly or through one or more of its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to Develop and Commercialize Juno Program Co-Co Products in the Field for Juno Territory Administration and otherwise perform its obligations under the Juno Co-Co Development Plan. Juno, directly or through one or more of its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to Manufacture [***] for Juno Territory Administration arising under the Juno Co-Co Program, if any, and to perform services with respect to [***] for Celgene Territory Administration arising under the Juno Co-Co Program, if any, as set forth in Section 2.4 of this Juno Lead Co-Co Agreement and Section 2.10 of the Master Collaboration Agreement. Celgene, directly or through one or more of its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to Manufacture Juno Program Co-Co Products that are [***] for clinical and commercial purposes for Celgene Territory Administration and Juno Territory Administration as set forth in Section 2.4 of this Juno Lead Co-Co Agreement and Section 2.10 of the Master Collaboration Agreement. Each Party will reasonably cooperate with the other Party in performing the foregoing obligations.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

11


2.2.3 Assistance . During the Juno Co-Co Term, each Party will cooperate with the other Party to provide reasonable assistance requested by such other Party, to facilitate the transfer of Development, Manufacture and Commercialization efforts related to Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products, including assistance with respect to regulatory and Clinical Trial transition matters, and with the transfer to the other Party of any additional Know-How licensed to such other Party under Section 2.6. Such cooperation will include providing the other Party with reasonable access in-person or by teleconference to such Party’s personnel involved in the Research, Development and Manufacture of Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products.

2.2.4 Development Plan .

(a) Scope and Preparation . Promptly after the Juno Lead Co-Co Agreement Effective Date, Juno (with respect to Development of the Juno Program Co-Co Product for Juno Territory Administration) and Celgene (with respect to Development of the Juno Program Co-Co Product for Celgene Territory Administration) shall each prepare and submit to the JRDC for review and approval a portion of an initial global Juno Co-Co Development Plan for Juno Program Co-Co Products, including any proposed Core Dossier Studies the JRDC determines are then ongoing, if any, and any additional Core Dossier Studies that such Party plans to conduct pursuant to the Juno Co-Co Program, as well as all other Clinical Trials and other studies to be conducted by either or both Parties pursuant to this Juno Lead Co-Co Agreement pursuant to Sections 2.2.5 and 2.2.6. All [***] incurred by either Party or its Affiliates in conducting (i) Development activities pursuant to the Juno Co-Co Development Plan, (ii) [***] for Juno Program Co-Co Products following the Juno Lead Co-Co Agreement Effective Date, or (iii) [***] pursuant to Section 2.2.5 following the Juno Lead Co-Co Agreement Effective Date shall be [***], and shall be [***]. [***] will set the required form and contents of the Juno Co-Co Development Plan, and will [***] each Juno Co-Co Development Plan. Subject to the Development Lead Party’s right to make a final decision pursuant to Section 4.2.5 of the Master Collaboration Agreement, the Juno Co-Co Development Plan shall incorporate any reasonable comments made by either Party in relation to the Development of Juno Program Co-Co Products either within or outside such Party’s territory.

(b) Updates . Following the initial preparation of the Juno Co-Co Development Plan as set forth in Section 2.2.4(a), the JRDC will update the Juno Co-Co Development Plan at least [***] during the Juno Co-Co Term prior to the grant of Regulatory Approval for the applicable Juno Program Co-Co Products, with Juno proposing the updates for the Juno Co-Co Development Plan with respect to Juno Program Co-Co Products for Juno Territory Administration and Celgene proposing the updates for the Juno Co-Co Development Plan with respect to Juno Program Co-Co Products for Celgene Territory Administration. In addition, either Party may reasonably request at any time that the JRDC consider and approve other updates to the Juno Co-Co Development Plan for Development activities to support Regulatory Approval on a global basis, including any Juno Co-Co Additional Study that the

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

12


Parties agree to conduct pursuant to Section 2.2.5(b)(1). Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will take any material action regarding the Development of Juno Program Co-Co Candidates or Juno Program Co-Co Products unless described in the Development Plan or with respect to Additional Studies, subject to Section 2.2.5. Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will perform any material Development activities for any Juno Program Co-Co Candidates, Juno Program Co-Co Products or Juno Program Co-Co Diagnostic Products unless described in the Juno Co-Co Development Plan, as specified in Section 2.2.5 or required by applicable laws or applicable Regulatory Authorities or independent monitoring boards for Clinical Trials.

2.2.5 Conduct of Certain Development Activities . Notwithstanding Sections 2.2.3 and 2.2.4:

(a) Ongoing Clinical Trials . If Juno was conducting a Clinical Trial(s) with respect to any Juno Program Co-Co Candidate and/or Juno Program Co-Co Product under the Collaboration which has not been completed as of the Juno Lead Co-Co Agreement Effective Date, including [***], then Juno will continue to be responsible for the performance of such Clinical Trial(s), unless otherwise agreed by the Parties through the JRDC, and the [***] incurred following the Juno Lead Co-Co Agreement Effective Date shall be [***]; and

(b) New Clinical Trials and Other Studies . If, following the Juno Lead Co-Co Agreement Effective Date, a Party (the “ Proposing Party ”) wishes (i) to conduct a Clinical Trial or other study of Juno Program Co-Co Products for Celgene Territory Administration (where the Proposing Party is Celgene), or for Juno Territory Administration (where the Proposing Party is Juno), (ii) to Develop Juno Program Co-Co Products in a country for which it is the Development Lead Party for any Indication in the Field other than an Indication for which such Juno Program Co-Co Products are being Developed pursuant to the Development Plan, (iii) to Develop a dosage form or formulation of Juno Program Co-Co Products in a country for which the Proposing Party is the Development Lead Party other than that being studied in the Juno Co-Co Development Plan, or (iv) to conduct any other Clinical Trial of a Juno Program Co-Co Product in the Field in a country for which the Proposing Party is the Development Lead Party, including any Clinical Trial that the JRDC determines is a [***], or any Clinical Trial or study that is not otherwise set forth in the Juno Co-Co Development Plan, or any Clinical Trial that the Proposing Party believes may have utility to support Regulatory Approval on a global basis and any Phase 4 Clinical Trial (each such study not already included in a Juno Co-Co Development Plan, a “ Juno Co-Co Additional Study ”), then (A) the Proposing Party shall first provide the proposed trial design and protocol for such Juno Co-Co Additional Study to the JRDC for [***] as to the [***] of such Juno Co-Co Additional Study, and shall incorporate [***], and (B) following such [***], provide the final proposed design and projected costs of such Juno Co-Co Additional Study to the JRDC. In any such case the following shall apply:

(1) If the other Party (the “Non-Proposing Party”), through its members of the JRDC, agrees [***] such Juno Co-Co Additional Study, the Parties shall amend the Juno Co-Co Development Plan and the Juno Co-Co Development Budget to include such Juno Co-Co Additional Study, and the [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

13


(2) If the Non-Proposing Party does not wish to [***] such proposed Juno Co-Co Additional Study [***], but the Non-Proposing Party has no material objection to such Juno Co-Co Additional Study, and Section 2.2.5(b)(4) does not apply, the Proposing Party may proceed with such Juno Co-Co Additional Study and would be solely responsible for [***]. In such case, the Non-Proposing Party [***], unless and until [***].

(3) For any Juno Co-Co Additional Study that the Non-Proposing Party does not wish to [***], [***], or to [***] of such Juno Program Co-Co Product for the Indication, formulation, dosage form or other attribute of such Juno Program Co-Co Product that was the subject of such Juno Co-Co Additional Study, if the data from such Juno Co-Co Additional Study is [***] then upon such [***], such Non-Proposing Party shall be deemed to have [***], and shall make the [***], with respect to such Juno Co-Co Additional Study. Notwithstanding the foregoing, the following mechanism shall apply [***]: Upon [***], the Non-Proposing Party shall [***], at the Non-Proposing Party’s option, either (x) [***], or (y) [***]. If upon [***] to the Proposing Party for [***] for such Juno Co-Co Additional Study [***], then the remainder [***] shall be [***], provided that in no event shall [***], with any [***] to the Non-Proposing Party [***], always subject to [***].

(4) Notwithstanding subsections (1) and (2), if the Non-Proposing Party believes a proposed Juno Co-Co Additional Study [***], such Non-Proposing Party would have the right to refer such matter to the JRDC and, as needed, the JRDC and JSC (if applicable) shall review such Non-Proposing Party’s concerns and consider mechanisms to mitigate or obviate any such concerns. If the JRDC or, if applicable, the JSC does not agree upon whether or not a proposed Juno Co-Co Additional Study would have [***], then [***] for such Program [***] such matter.

(5) If the Non-Proposing Party elects to [***] a Juno Co-Co Additional Study, or elects to [***] pursuant to Section 2.2.6, or is subject to a [***], as set forth in this Section 2.2.5, then following such Non-Proposing Party’s decision to [***], as applicable, [***] (including any Juno Program Co-Co Product Data) would be available for use by (A) [***] in connection with Juno Program Co-Co Products in the Field in the [***] and for [***] Territory Administration, (B) [***] in the [***] Territory and for [***] Territory Administration, and (C) by [***] in the Territory to [***] set forth in this Juno Lead Co-Co Agreement.

2.2.6 [***] Right . Notwithstanding Section 2.2.5(b)(2) above, and subject to Section 2.2.5(b)(3), [***], the Non-Proposing Party would have the right to elect by written notice to the Proposing Party to [***]. In such case, (a) the Parties shall [***], and (b) the Non-Proposing Party shall [***]. Upon any such [***]. If the Non-Proposing Party elects [***] within [***] after the Non-Proposing Party notifies the Proposing Party in writing that the Non-Proposing Party [***] pursuant to this Section 2.2.6.

2.2.7 Retained Rights for Certain Development Activities . Notwithstanding

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

14


Section, 2.2.3 and 2.2.5, (a) Juno retains the right to conduct Development of Juno Program Co-Co Products in the ROW Territory, (b) Celgene retains the right to conduct Development of Juno Program Co-Co Products outside the ROW Territory, in each case of (a) and (b) [***] in connection with Juno’s Commercialization of Juno Program Co-Co Product for Juno Territory Administration, or Celgene’s Commercialization of Juno Program Co-Co Product for Celgene Territory Administration, as applicable, and (c) (i) Juno retains the right in the ROW Territory, and (ii) Celgene retains the right in the North America Territory, to Manufacture and have Manufactured Juno Program Co-Co Candidates and Juno Program Co-Co Products [***], in each case to the extent such Party has the right to conduct such Manufacturing pursuant to the Manufacturing Agreement. If either Party plans to undertake such activities, it shall so notify the other Party and [***]. The rights retained by the Parties in this Section 2.2.7 include the right [***] Juno Program Co-Co Products, or Juno Program Co-Co Diagnostic Products in the ROW Territory (in the case of Juno) and outside the ROW Territory (in the case of Celgene), provided that the Party seeking [***], and provided further that if the Parties are [***] will be considered a [***].

2.2.8 Juno Co-Co Development Budget and Costs .

(a) Territory Development Budgets . Promptly after the Juno Lead Co-Co Agreement Effective Date, and concurrently with the preparation of the Juno Co-Co Development Plan pursuant to Section 2.2.4, the Parties shall cooperate to prepare the Juno Co-Co Development Budget. Juno shall be responsible for the preparation of the portion of the budget for the Development activities, [***] Juno Program Co-Co Products in, the North America Territory (the “ North America Development Budget ”), and Celgene shall be responsible for the preparation of the portion of the budget for the Development activities, [***] Juno Program Co-Co Products in, the ROW Territory (the “ ROW Development Budget ”). For Juno Co-Co Development Costs to be incurred from and after the Juno Lead Co-Co Agreement Effective Date, the JRDC will review and approve the Juno Co-Co Development Budget reasonably in advance of the applicable Juno Co-Co Development Costs being incurred (with the intent being to obtain such approval [***] in advance of such costs being incurred, where practicable). Thereafter, [***] will update and provide the JSC with a copy of the Juno Co-Co Development Budget, including the budgeted Juno Co-Co Development Costs, each Calendar Year at a meeting of the JSC sufficiently in advance of the next Calendar Year so as to provide the Parties with an opportunity to budget accordingly, but in any event no later than [***] of each Calendar Year during the Juno Co-Co Term. The JSC will review and approve any such update or any other amendment to the Juno Co-Co Development Budget. In addition, either Party may request at any time that the JSC consider and approve other updates to the Juno Co-Co Development Budget. The Parties understand and agree that, if the Non-Proposing Party [***] as set forth in Section 2.2.5, the Proposing Party shall [***] (but, for clarity, shall [***].

(b) [***] Costs . Subject to subsection (a) and Sections 2.2.5 and 2.2.6, all [***] arising from either Party’s conduct of Development with respect to the Juno Co-Co Program in accordance with the Juno Co-Co Development Plan and the Juno Co-Co Development Budget [***]. For clarity, this Section 2.2.8(b) shall not apply to [***], which [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

15


(c) Research Cost Report . [***] following the Juno Lead Co-Co Agreement Effective Date, the JRDC shall agree upon a form of cost report to be prepared and submitted by each Party to the JRDC on a [***] basis setting forth the costs incurred by each Party in conducting Research activities in accordance with the Juno Co-Co Development Plan and the Research budget in the [***] (the “ Research Cost Report ”). Within [***] after the end of each Calendar Quarter following the Juno Lead Co-Co Agreement Effective Date (or the determination by the JRDC of the scope of Research activities to be conducted by the Parties under the Juno Co-Co Development Plan, if later), each Party shall submit its Research Cost Report for the previous Calendar Quarter to the JRDC. Such [***].

2.2.9 Meetings and Reports . During the Juno Co-Co Term:

(a) Committees . The JSC, the JMC, the JRDC, the Patent Committee and the JCC shall remain established as set forth in Article 4 of the Master Collaboration Agreement and shall be responsible for performing the functions set forth in Article 4 of the Master Collaboration Agreement. Notwithstanding the foregoing, and subject to Sections 2.2.5 and 2.2.6 with respect to (i) matters that are [***] Celgene’s Development and Commercialization of Juno Program Co-Co Candidates and Juno Program Co-Co Products in the ROW Territory and are [***] or are otherwise subject to [***], and (ii) matters that are [***] Juno’s Development and Commercialization of Juno Program Co-Co Candidates and Juno Program Co-Co Products in the North America Territory and are [***] or are otherwise subject to [***], and except for matters [***], the JSC and the JRDC shall serve solely as a forum for exchanging information and facilitating discussions. In each case each Party shall have the final decision making right with respect to all Development and Commercialization Activities relating to the Juno Co-Co Program that [***], as applicable, and which are [***]. For any matters arising in relation to the Development and Commercialization of Juno Program Co-Co Products or Juno Program Co-Co Candidates that [***], or for [***], or which the Parties are [***], the decision shall be referred to the Executive Officers for resolution and shall thereafter be subject to Section 4.2.5 of the Master Collaboration Agreement and this Section 2.2.9(a);

(b) Status Reports . Each Party shall provide a reasonably detailed written progress report to the JRDC, at least [***], on the status of its activities and efforts with respect to the Juno Co-Co Program, including the status of any Research activities under the Juno Co-Co Program, or any Juno Program Co-Co Candidate being Developed and/or Commercialized under such Juno Co-Co Program, including (to the extent not covered in the Juno Co-Co Development Plan): (i) the design, status and results of any Clinical Trials (including any Core Dossier Studies and Additional Studies) and other studies of Juno Program Co-Co Products; and (ii) any key Development or regulatory events, and any Regulatory Approvals filed for or achieved, for Juno Program Co-Co Products. Such report should be provided no later than [***] before the next scheduled meeting of the JRDC, in order to provide the JRDC the opportunity to review such report prior to such meeting.

2.3 Regulatory .

2.3.1 Transfer of Regulatory Materials . Juno shall transfer to Celgene, promptly

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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after the Juno Lead Co-Co Agreement Effective Date (but subject to Section 2.3.2), any and all Regulatory Materials (including any foreign counterparts of the IND and BLA) for all Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products in or for the ROW Territory, and thereafter Celgene (or its designee) shall file and hold title to all Regulatory Materials and Regulatory Approvals and supplements thereto relating to Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products in and for the ROW Territory.

2.3.2 Responsibility . As of and after the date upon which the transfer is effected pursuant to Section 2.3.1, (a) Celgene will be the Regulatory Lead Party for Development, Manufacture and Commercialization of Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products in the Field in the ROW Territory and for Celgene Territory Administration, and (b) Juno will be the Regulatory Lead Party for Development, Manufacture and Commercialization of Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products in the Field outside the ROW Territory and for Juno Territory Administration. In each case the applicable Regulatory Lead Party shall take full responsibility for preparing and filing the relevant Regulatory Materials and seeking Regulatory Approval. During the Juno Co-Co Term, and in addition to each Party’s obligations pursuant to Sections 2.2.9(b) and 2.3.3, each Regulatory Lead Party shall keep the other Party, through the JRDC, reasonably informed, through updates at each meeting of the JRDC, of material regulatory activities and events that occur with respect to Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products in the ROW Territory. Notwithstanding the foregoing, in the event Juno continues to be responsible for the performance of a Clinical Trial pursuant to and in accordance with Section 2.2.5(a), Juno will retain ownership of any Regulatory Materials and Regulatory Approvals (including any equivalent of the IND for any country in the ROW Territory) for Juno Program Co-Co Candidates and Juno Program Co-Co Products until completion of such Clinical Trial. In the event of failure to assign such Regulatory Materials and Regulatory Approvals to Celgene as required by Section 2.3.1 and this Section 2.3.2, Juno hereby consents and grants to Celgene the right to access and reference (without any further action required on the part of Juno, whose authorization to file this consent with any Regulatory Authority is hereby granted) any such Regulatory Materials and Regulatory Approvals.

2.3.3 Rights to Use Juno Program Co-Co Product Data .

(a) Each Party, as the Development Lead Party in a given country for Development of Juno Program Co-Co Candidates and Juno Program Co-Co Products in such country, shall keep accurate records of all Juno Program Co-Co Product Data generated as a result of all activity by or on behalf of such Development Lead Party in performing Development and Commercialization in relation to Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products, including any data generated pursuant to the Party’s activities [***]. Except [***], each Development Lead Party shall provide the other Party with copies of all such Juno Program Co-Co Product Data Controlled by the Development Lead Party during the Juno Co-Co Term that is [***] the Development and Commercialization of Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products promptly following the generation of such Juno Program Co-Co Product Data. [***] shall be included in the [***] shall be included [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(b) Notwithstanding anything to the contrary in this Juno Lead Co-Co Agreement, each Development Lead Party shall promptly provide to the other Party, [***], copies of and rights of reference to and use of all Juno Program Co-Co Product Data that is Controlled by the Development Lead Party, and that are relevant to or necessary to address issues relating to: (i) the safety of Juno Program Co-Co Products within or outside the ROW Territory, including data that is related to adverse effects experienced with Juno Program Co-Co Candidates or Juno Program Co-Co Products, or (ii) CMC Activities relating to Juno Program Co-Co Candidates or Juno Program Co-Co Products, and in each of (i) and (ii), that are required to be reported or made available to Regulatory Authorities within or outside the ROW Territory, when and as such data become available (collectively, “ Safety and CMC Data ”). Each Party shall use the Safety and CMC Data provided to it pursuant to this Section 2.3.3(b) solely to Develop and Commercialize Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products in the Field in the ROW Territory (in the case of Celgene), and outside the ROW Territory in the Field (in the case of Juno).

2.3.4 Communication with Regulatory Authorities . Subject to Sections 2.3.5 and 2.3.7, Celgene shall be responsible for handling all complaints and communications (including with Regulatory Authorities) relating to Juno Program Co-Co Products for Celgene Territory Administration, and Juno shall be responsible for handling all complaints and communications (including with Regulatory Authorities) relating to Juno Program Co-Co Products for Juno Territory Administration. Without limiting the foregoing, each Party when acting as the Regulatory Lead Party shall promptly notify the other Party (which may be through the JRDC or the JSC) of any material oral or written communications to or from Regulatory Authorities, and any Regulatory Materials or filings on matters related to the Juno Program Co-Co Products, or which may reasonably be deemed to impact the Development, Manufacture, marketing, Regulatory Approval or Commercialization of Juno Program Co-Co Products, outside the Regulatory Lead Party’s territory, and shall provide the other Party with copies of any such material written communications within [***], or earlier as specified in the Pharmacovigilance Agreement, of receipt or delivery of such communication, as the case may be, or such earlier date as required by Applicable Laws, the FDA, the EMA or other relevant Regulatory Authority. In addition the Regulatory Lead Party shall provide the other Party with copies of Regulatory Materials, including any material regulatory filings or communications, at least [***] in advance of any proposed filing, and shall give such other Party an opportunity to review and comment on such regulatory communications or filings. In addition to the foregoing, each Party shall give the other Party reasonable opportunity (not to be less than [***] to review and comment on such Regulatory Materials or filings, or on any proposed response to any such oral or written communications to or from Regulatory Authorities prior to submitting any response thereto. The Regulatory Lead Party shall consider in good faith any reasonable comments made by the other Party in relation to such Regulatory Materials, provided that the Regulatory Lead Party shall have the final decision-making right with respect to the nature and content of any Regulatory Materials, communications or filings to the extent solely relating to such Regulatory Lead Party’s territory, or the Administration of Juno Program Co-Co Products in such Regulatory Lead Party’s territory, and the Regulatory Lead Party shall provide the other Party with a copy of the final response, filing or communications, as specified herein.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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2.3.5 Pharmacovigilance; REMS .

(a) The Parties will enter into a pharmacovigilance agreement within [***] after the Juno Lead Co-Co Agreement Effective Date that shall govern their obligations with respect to the exchange, handling and reporting of adverse events, other safety information and Juno Program Co-Co Product complaints during Development and Commercialization of the Juno Program Co-Co Products in each Party’s territory (the “ Pharmacovigilance Agreement ”). In general, the Pharmacovigilance Agreement will provide that [***] will be responsible for such obligations for Juno Program Co-Co Products for Celgene Territory Administration, and [***] will be responsible for such obligations for Juno Program Co-Co Products for Juno Territory Administration. The Pharmacovigilance Agreement will also require (i) [***] to deploy and administer any REMS or other safety monitoring activity implemented for the Juno Program Co-Co Product in the ROW Territory, and to be responsible for all pharmacovigilance activities for the Juno Program Co-Co Product in the ROW Territory, (ii) [***] to deploy and administer any REMS or other safety monitoring activity implemented for the Juno Program Co-Co Product outside the ROW Territory, and to be responsible for all pharmacovigilance activities for the Juno Program Co-Co Product outside the ROW Territory, and (iii) [***] to establish and maintain a global safety database for Products that will contain all information and data arising from the Parties’ activities with respect to safety matters that is required to be contributed by each Party pursuant to the Pharmacovigilance Agreement, including information and data arising out of any REMS and safety monitoring activities.

(b) The Parties shall discuss, through the JRDC, and agree upon standard provisions reasonably acceptable to both Parties regarding: (i) [***] in connection with Juno Program Co-Co Product [***], and (ii) [***] which may result in [***] each Party with respect thereto.

(c) Each Party shall inform the other Party during the Juno Co-Co Term, in accordance with the Pharmacovigilance Agreement, of the side effect profiles for Juno Program Co-Co Candidates and Juno Program Co-Co Products, including pregnancy and suspected pregnancy, damages, toxicity or sensitivity reactions associated with the use of any Juno Program Co-Co Candidate or Juno Program Co-Co Product, regardless of whether these effects are attributable to such Juno Program Co-Co Candidate or Juno Program Co-Co Product. Each Party shall have the right to take [***], including the right to [***] of such Juno Program Co-Co Candidate or Juno Program Co-Co Product, if there are [***], as determined in accordance with the Pharmacovigilance Agreement, [***].

(d) In accordance with the procedures established by the Parties under the Pharmacovigilance Agreement, each Party shall cooperate with the other Party and share information concerning the pharmaceutical safety of each Juno Program Co-Co Candidate and Juno Program Co-Co Product. Each Party shall: (i) promptly advise the other Party of [***] of such Juno Program Co-Co Candidate or Juno Program Co-Co Product and any actions taken in

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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response to such information; (ii) promptly advise the other Party of [***] of such Juno Program Co-Co Candidate or Juno Program Co-Co Product [***], as far as this concerns [***]; and (iii) timely provide the other Party with [***] such Juno Program Co-Co Candidate or Juno Program Co-Co Product of which the [***], as far as this relates to [***] to perform their obligations or exercise their rights under this Juno Lead Co-Co Agreement. Treatment of safety information, standard operating procedures and training, as well as a statement of respective regulatory obligations shall be agreed in the Pharmacovigilance Agreement.

2.3.6 Right of Reference .

(a) Except as provided in Section 2.2.5(b)(2), Celgene and its Affiliates and Sublicensees shall have access to all data contained or referenced in any Regulatory Materials (including any Regulatory Approvals), including any Juno Program Co-Co Product Data, Controlled by Juno that are necessary for the Development, Manufacture or Commercialization (as set forth in this Juno Lead Co-Co Agreement) of Juno Program Co-Co Candidates, Juno Program Co-Co Products, and Juno Program Co-Co Diagnostic Products in the ROW Territory and/or for Celgene Territory Administration; and

(b) Except as provided in Section 2.2.5(b)(2), Juno and its Affiliates and Sublicensees shall have access to all data contained or referenced in any Regulatory Materials (including any Regulatory Approvals), including any Juno Program Co-Co Product Data, Controlled by Celgene that are necessary for the Development, Manufacture or Commercialization (as set forth in this Juno Lead Co-Co Agreement) of Juno Program Co-Co Candidates and Juno Program Co-Co Products, and Juno Program Co-Co Diagnostic Products outside the ROW Territory and/or for Juno Territory Administration.

2.3.7 Compliance .

(a) Obligations . Each of Celgene and Juno shall reasonably cooperate with the other Party in its efforts to ensure that all government reporting, including price and gift reporting, sales, marketing and promotional practices in respect of each Juno Program Co-Co Product for Celgene Territory Administration and Juno Territory Administration meet the standards required by applicable Laws.

(b) Information . Each of Celgene and Juno shall reasonably cooperate with the other Party to provide the other Party access to any and all information, data and reports required by the other in order to enable the other Party to comply with applicable Laws, including reporting requirements, or the equivalent thereof anywhere the Parties are Developing or Commercializing Juno Program Co-Co Products in the Territory, in a timely and appropriate manner. Each Party shall ensure that any such reporting is true, complete and correct in all respects; provided however that neither Party shall be held responsible for submitting erroneous reports to the extent such deficiencies result from information provided by the other Party which itself was not true, complete and correct.

(c) Cooperation . Celgene and Juno shall confer with each other on a regular basis through the JCC to discuss and compare their respective procedures and methodologies

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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relating to each Party’s compliance with applicable Laws or fulfilment of any other obligation in this Section 2.3. In the event that the Parties have different understandings or interpretations of this Section 2.3 or of the applicability of, or standards required by any applicable Laws, then the Parties shall confer and seek to reach common agreement on such matters, and in the absence of such agreement, the escalation and decision making procedures set forth in Section 4.2.5 of the Master Collaboration Agreement shall apply.

(d) Antitrust Compliance . For the avoidance of doubt, the Parties shall continue to comply with Section 3.2 of the Master Collaboration Agreement.

2.4 Manufacturing and Supply . The provisions of Section 2.10 of the Master Collaboration Agreement and the Manufacturing Agreement (if executed) shall apply to the Parties’ establishment and operation of manufacturing facilities for [***] Products and [***] Products in the Territory. The [***] pursuant to this Juno Lead Co-Co Agreement shall be an Allowable Expense and shall be included in the Profit & Loss Share.

2.5 Records; Reports; Results . Each Party shall maintain or cause to be maintained complete, current and accurate records of all Development activities conducted by it (or its Affiliates and subcontractors) hereunder, and all data, results and analyses (including site records and master files) and other information resulting from such activities. Such records shall (i) fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes, and (ii) record only such activities and shall not include or be commingled with records of activities that do not relate to the Development and Commercialization of Juno Program Co-Co Products, Juno Program Co-Co Candidates and/or Juno Program Co-Co Diagnostic Products, or activities carried out pursuant to this Juno Lead Co-Co Agreement. Each Party shall document all non-clinical studies and Clinical Trials in formal written study records according to applicable Laws, including national and international guidelines such as ICH, GCP, GLP and GMP. All such records shall be retained by the relevant Party for at least [***] after the termination of this Juno Lead Co-Co Agreement or for such longer period as may be required by applicable Law. Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times, as reasonably requested by Juno.

2.6 Materials Transfer; License .

2.6.1 Materials Transfer . During the Juno Co-Co Term, either Party (the “ Juno Co-Co Transferring Party ”) shall transfer, if [***] (the “ Juno Co-Co Materials Receiving Party ”), certain [***], which may include [***] (the “ Juno Co-Co Materials ”) for use by the Juno Co-Co Materials Receiving Party in furtherance of its rights and the conduct of its obligations under this Juno Lead Co-Co Agreement (the “ Juno Co-Co Purpose ”). All transfers of such Juno Co-Co Materials by the Juno Co-Co Transferring Party to the Juno Co-Co Materials Receiving Party shall be documented in a material transfer agreement substantially in the form of Exhibit E, which sets forth the type and name of the Juno Co-Co Material transferred, the amount of the Juno Co-Co Material transferred, the date of the transfer of such Juno Co-Co Material and the Juno Co-Co Purpose (each, a “ Juno Co-Co Material Transfer Agreement ”).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Such Juno Co-Co Materials will be provided to the requesting Party within a reasonable time period after the Parties execute the relevant Juno Co-Co Material Transfer Agreement, not to exceed [***]. Neither Party will unreasonably withhold its consent to any request made by the other Party pursuant to this Section 2.6.1, except that Juno shall have no obligation to transfer to Celgene [***] unless it otherwise agrees in writing, [***] and Celgene shall have no obligation to transfer to Juno [***] unless it otherwise agrees in writing, [***]. The Parties agree that the exchanged Juno Co-Co Materials shall be used in compliance with applicable Law and the terms and conditions of this Juno Lead Co-Co Agreement, and shall not be reverse engineered or chemically analysed, except if required by the Juno Program Co-Co Purpose or otherwise agreed to by the Parties in writing.

2.6.2 License by Juno Co-Co Transferring Party . At the time the Juno Co-Co Transferring Party provides the Juno Program Co-Co Materials to the Juno Co-Co Materials Receiving Party as provided herein and to the extent not separately licensed under this Juno Lead Co-Co Agreement, the Juno Co-Co Transferring Party hereby grants and shall cause (within [***] after the execution of any Juno Co-Co Material Transfer Agreement) its Affiliates to grant to the Juno Co-Co Materials Receiving Party a non-exclusive license under the Patents and Know-How Controlled by it, to use such Juno Co-Co Materials solely for the Juno Co-Co Purpose, and such license, upon termination of this Juno Lead Co-Co Agreement (subject to Article 10), completion of the Juno Co-Co Purpose, or discontinuation of the use of such Juno Co-Co Materials (whichever occurs first), shall automatically terminate. Except as otherwise provided under this Juno Lead Co-Co Agreement, all such Juno Co-Co Materials delivered by the Juno Co-Co Transferring Party, shall only be used by or on behalf of (as permitted in this Section 2.6.2) the Juno Co-Co Materials Receiving Party in furtherance of the Juno Co-Co Purpose, and shall be returned to the Juno Co-Co Transferring Party or destroyed, in the Co-Co Transferring Party’s sole discretion, upon the termination of this Juno Lead Co-Co Agreement (subject to Article 10) or upon the discontinuation of the use of such Juno Co-Co Materials (whichever occurs first), unless such Party has the right to continue to use such materials under the Master Collaboration Agreement, a Development & Commercialization Agreement for purposes permitted thereunder, including pursuant to material transfer agreements executed in connection therewith. The Juno Co-Co Materials Receiving Party shall not [***].

2.6.3 NO WARRANTIES . THE JUNO CO-CO MATERIALS SUPPLIED BY THE TRANSFERRING PARTY UNDER THIS SECTION 2.6 ARE SUPPLIED “AS IS” AND, EXCEPT AS OTHERWISE SET FORTH IN THIS JUNO LEAD CO-CO AGREEMENT, THE TRANSFERRING PARTY MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE CO-CO MATERIALS OR USE THEREOF DO NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS OF A THIRD PARTY. The Juno Co-Co Materials Receiving Party assumes all liability for damages that may arise from its use, storage or disposal of the Co-Co Materials. Except as otherwise set forth in this Juno Lead Co-Co Agreement, the Juno Co-Co Transferring Party shall not be liable to the Juno Co-Co Materials Receiving Party for any loss, claim or demand made by the Juno Co-Co Materials Receiving Party, or made against the Juno Co-Co Materials Receiving Party by any Third Party, due to or arising from the use of the Juno Co-Co Materials, except to the extent such loss, claim or demand is caused by the wilful misconduct of the Transferring Party.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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2.7 No Representation . Subject to the Section 2.2.2, neither Party makes any representation, warranty or guarantee that the Juno Co-Co Program will be successful, or that any other particular results will be achieved with respect to the Juno Co-Co Program, Juno Program Co-Co Target, any Juno Program Co-Co Candidate, any Juno Program Co-Co Product or any Juno Program Co-Co Diagnostic Product hereunder.

2.8 Covenant During Juno Co-Co Term . Commencing on the Juno Lead Co-Co Agreement Effective Date until expiration of each Party’s exclusivity obligations pursuant to Article 4 with respect to the Juno Co-Co Program, neither Party nor its Affiliates will, other than to an Affiliate of such Party who agrees in writing to be bound by the terms and conditions of this Juno Lead Co-Co Agreement, (a) assign, transfer, convey, encumber (including any liens or charges, but excluding any licenses, which are the subject of subsection (b), below) or dispose of, or enter into any agreement with any Third Party to assign, transfer, convey, encumber (including any liens or charges, but excluding any licenses, which are the subject to subsection (b), below) or dispose of, any assets [***] (the “ Juno Co-Co Program Assets ”), except to the extent such assignment, transfer, conveyance, encumbrance or disposition would not conflict with or adversely affect in any respect any of the rights granted to the other Party hereunder, (b) license or grant to any Third Party, or agree to license or grant to any Third Party, any rights to any Juno Co-Co Program Assets if such license or grant would conflict with or adversely affect in any respect any of the rights granted to the other Party hereunder, or (c) disclose any Confidential Information relating to the Juno Co-Co Program Assets to any Third Party if such disclosure would impair or conflict in any respect with any of the rights granted to the other Party hereunder. Notwithstanding this Section 2.8, either Party and/or its Affiliates shall have the right to assign, transfer, convey or dispose of any assets specifically related to this Juno Co-Co Program to [***]; provided that (i) [***] this Juno Lead Co-Co Agreement, and (ii) such [***].

ARTICLE 3

COMMERCIALIZATION; RIGHT TO OPT IN

3.1 Commercialization.

3.1.1 Commercialization Lead Party . Subject to the terms and conditions of this Juno Lead Co-Co Agreement, including Juno’s rights under Section 3.1.3, Celgene will have sole responsibility, and shall be the Commercialization Lead Party for all Commercialization Activities for Juno Program Co-Co Products for Celgene Territory Administration. Subject to the terms and conditions of this Juno Lead Co-Co Agreement, including Celgene’s rights under Section 3.1.2, Juno shall have sole responsibility, and shall be the Commercialization Lead Party for all Juno Program Co-Co Products for Juno Territory Administration, and for clarity Juno retains the sole right to conduct all Commercialization Activities for Juno Program Co-Co Products that are [***] Products in the China Territory as provided in Section 2.1.5 of the Master Collaboration Agreement. Subject to the terms and conditions of this Juno Lead Co-Co

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Agreement, including this Article 3, the Commercialization Lead Party for Juno Program Co-Co Products under this Juno Lead Co-Co Agreement shall [***] Commercialization of Juno Program Co-Co Products [***] as the Commercialization Lead Party, in accordance with Section 4.2.5 of the Master Collaboration Agreement. The non-Commercialization Lead Party (itself or by or through any others, including any Affiliates or Sublicensees, [***] regarding the Commercialization of Juno Program Co-Co Products [***] unless mutually agreed in writing following Celgene’s election to participate in Commercialization Activities pursuant to Section 3.1.2, or Juno’s exercise of the Commercialization Opt-In Right pursuant to Section 3.1.3 (solely in relation to the Major EU Market Countries), or described in the Juno Co-Co Commercialization Plan, or otherwise approved by the JCC.

3.1.2 Celgene Co-Commercialization Right . On a Juno Program Co-Co Product-by-Juno Program Co-Co Product basis, for any Juno Co-Co Program that was:

(a) a Celgene Co-Promote Program, Celgene shall have the right, in its sole discretion, exercisable upon written notice (the “ Celgene Co-Commercialization Notice ”) delivered to Juno at any time prior to, or within [***] following [***], in the North America Territory for such Juno Co-Co Program Product, to elect to provide between [***] and [***] of the Commercialization Activities included in the Juno Co-Co Commercialization Opt-In Terms for such Juno Program Co-Co Product for Juno Territory Administration (including [***] in the North America Territory for such Juno Program Co-Co Product); or

(b) (i) an [***] BD Program, for which Celgene delivered an [***] Option Exercise Notice as set forth in Section 3.1.5 of the Master Collaboration Agreement, (ii) an Eligible BD Program for which Juno was the BD Acquiring Party and for which Celgene delivered a BD Option Exercise Notice as set forth in Section 2.2.1 of the Master Collaboration Agreement (and which did not become a [***] Program), or (iii) a [***] BD Program for which [***] was the BD Acquiring Party and for which [***] delivered a BD Option Exercise Notice as set forth in Section 2.2.1 of the Master Collaboration Agreement (and which did not become a [***] Program), then Celgene shall have the right, [***], to deliver a Celgene Co-Commercialization Notice to Juno at any time prior to, or within [***], in the North America Territory for use of such Juno Co-Co Program Product, to elect to provide between [***] and [***] of the Commercialization Activities included in the Juno Co-Co Commercialization Opt-In Terms for such Juno Program Co-Co Product for Juno Territory Administration (including [***] in the North America Territory for such Juno Program Co-Co Product).

3.1.3 Juno Opt-In Right for Certain Commercialization Activities .

(a) If the Juno Co-Co Program under this Juno Lead Co-Co Agreement is a Celgene Co-Promote Program, then, on a Juno Program Co-Co Product-by-Juno Program Co-Co Product basis, Juno may exercise a Commercialization Opt-In Right upon written notice to Celgene at any time [***] in the ROW Territory for such Juno Program Co-Co Product, to elect to provide between [***] and [***] of the Commercialization Activities included in the Juno Co-Co Commercialization Opt-In Terms for such Juno Program Co-Co Product in the Major EU Market Countries (including [***] in the Major EU Market Countries for such Juno Program Co-Co Product).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(b) If the Juno Co-Co Program under this Juno Lead Co-Co Agreement was (i) an Eligible BD Program for which Celgene delivered a BD Option Exercise Notice pursuant to Section 2.2.1 of the Master Collaboration Agreement, or (ii) an [***] BD Program for which Celgene exercised an Option pursuant to Section 3.1.5 of the Master Collaboration Agreement, then on a Juno Program Co-Co Product-by-Juno Program Co-Co Product basis, Juno may exercise a Commercialization Opt-In Right, upon written notice to Celgene at any time prior to, or [***] in the ROW Territory for use of a Juno Program Co-Co Product, to elect to provide between [***] and [***] of the Commercialization Activities included in the Juno Co-Co Commercialization Opt-In Terms for such Juno Program Co-Co Product in the Major EU Market Countries (including [***] in the Major EU Market Countries for such Juno Program Co-Co Product).

3.1.4 Commercialization Opt-In .

(a) If Celgene provides a Celgene Co-Commercialization Notice to Juno pursuant to Section 3.1.2, [***], update the Juno Co-Co Commercialization Plan for such countries to include the rights and obligations with respect thereto, which shall in any event be consistent with the then-existing Juno Co-Co Commercialization Plan for such countries prepared by [***] pursuant to Section 3.1.6, and which shall include the terms set forth in the Juno Co-Co Commercialization Opt-In Terms attached hereto as Exhibit F .

(b) If Juno exercises the Commercialization Opt-In Right pursuant to Section 3.1.3, [***], update the Juno Co-Co Commercialization Plan for such countries to include the rights and obligations with respect thereto, which shall in any event be consistent with the then-existing Commercialization Plan for such countries prepared by [***] pursuant to Section 3.1.6, and which shall include the terms set forth in the Juno Co-Co Commercialization Opt-In Terms attached hereto as Exhibit F .

(c) Once the terms of such participation have been agreed, the Juno Co-Co Commercialization Plan will set forth [***] (i) [***], and (ii) [***], as applicable.

3.1.5 Costs of Participation in Commercialization . On a Juno Program Co-Co Product-by-Juno Program Co-Co Product basis, following (a) the exercise by Juno of the Commercialization Opt-In Right for a Juno Program Co-Co Product pursuant to Section 3.1.3, and/or (b) Celgene’s election to co-Commercialize a Juno Program Co-Co Product for Juno Territory Administration pursuant to Section 3.1.2, all costs associated with each Party’s participation in Commercialization Activities in relation to Juno Program Co-Co Products in the Major EU Market Countries (in the case of Juno’s exercise of the Commercialization Opt-In Right), or in the North America Territory (as a result of Celgene’s delivery of a Celgene Co-Commercialization Notice) with respect to such Juno Co-Co Programs [***] pursuant to this Juno Lead Co-Co Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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3.1.6 Juno Co-Co Commercialization Plan .

(a) No later than [***] for the first Juno Program Co-Co Product for Celgene Territory Administration (as set forth in the Juno Co-Co Development Plan). Celgene will prepare an initial Commercialization plan for such Juno Program Co-Co Product for Celgene Territory Administration covering the [***] after the First Juno Program Co-Co Sale of such Juno Program Co-Co Product in the relevant country(ies).

(b) No later than [***] for the first Juno Program Co-Co Product for Juno Territory Administration, Juno will prepare an initial Commercialization plan for such Juno Program Co-Co Product for Juno Territory Administration, covering [***] after First Juno Program Co-Co Sale of such Juno Program Co-Co Product for Juno Territory Administration in the relevant country(ies).

(c) The JCC will review and comment on each Commercialization Lead Party’s plan for Commercialization of Juno Program Co-Co Products in the countries in which it is the Juno Co-Co Lead Party, and collectively each Juno Co-Co Lead Party’s plan for Commercialization shall constitute the Juno Co-Co Commercialization Plan. Thereafter, the Commercialization Lead Party (in consultation with the opting-in Party) will update the relevant portion of the Juno Co-Co Commercialization Plan (for the [***] annually, and the JCC will review and comment on any such update or other amendment to such Juno Co-Co Commercialization Plan. The Commercialization Lead Party will also update the Juno Co-Co Commercialization Plan as provided in Section 3.3. Either Party may request at any time that the JCC consider other updates to such Juno Co-Co Commercialization Plan. The JCC will set the required form and contents of any Juno Co-Co Commercialization Plan. The Juno Co-Co Commercialization Plan will specify, as applicable, among other things, for each applicable country and Juno Program Co-Co Product, the principles established pursuant to Section 3.3.2 for global branding of Juno Program Co-Co Products.

3.1.7 Commercialization Activities .

(a) Training . The Commercialization Lead Party in any country in which the other Party participates in Commercialization of Juno Program Co-Co Products will (i) [***] with respect to Juno Program Co-Co Products, and will [***] for such sales representatives therefor, and (ii) [***] for the Juno Program Co-Co Product, in each case [***]. [***] will [***] for the Program Co-Co Product in the Commercialization Lead Party’s territory to [***] as and to the extent consistent with applicable Law. The Parties will cooperate, through the JCC, to determine and coordinate with respect to implementation of any training and conduct and content of detailing for Commercialization Activities for Juno Program Co-Co Products that apply throughout the Territory.

(b) Sales Representatives; Detailing . The following provisions shall apply to the activities of sales representatives with respect to Commercialization of Juno Program Co-Co Products:

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(i) For Juno Program Co-Co Products in countries in which the non-Commercialization Lead Party provides Commercialization support to the Commercialization Lead Party, each Party will be solely responsible for recruiting, hiring and maintaining its sales force of sales representatives for promotion of the Juno Program Co-Co Product in the Territory, in accordance with (A) the share of Commercialization Activities held by such Party in the North America Territory and the ROW Territory pursuant to Sections 3.1.2 and 3.1.3 and (B) its standard procedures and the requirements of this Juno Lead Co-Co Agreement.

(ii) Each Party, when acting as the non-Commercialization Lead Party in a given country, shall engage sales representatives having the minimum qualifications set forth in Schedule 3.1.7(b) , provided that if Juno has exercised its right to co-Commercialize in the Major EU Market Countries pursuant to Section 3.1.3, Juno may, on a Juno Program Co-Co Product-by-Juno Program Co-Co Product and country-by-country basis within the Major EU Market Countries, [***] Commercialization Activities for a Juno Program Co-Co Product in an applicable country pursuant to Section 3.1.3, and thereafter, Juno may [***]. If Celgene delivers a Co-Commercialization Notice for Juno Program Co-Co Products in the North America Territory pursuant to Section 3.1.2, [***].

(iii) The Juno Co-Co Commercialization Plan will set forth (A) [***], as applicable, consistent with the foregoing, (B) policies and processes for the [***], (C) [***], (D) the [***] sales representatives for Juno Program Co-Co Products in each Calendar Year, (E) the allocation of [***] between the Parties, (F) development of [***], and (G) coordinating strategies for [***].

(iv) If [***], at any particular time, for any reason, the number of sales representatives specified in the Juno Co-Co Commercialization Plan to be provided [***], then [***] for the applicable territory will have the right to [***] until such time as [***], and, for clarity, all costs incurred by [***] related to [***].

(v) Each Party will be responsible for the activities of such sales representatives, including compliance by such sales representatives with training and detailing requirements. In particular, each Party will provide its sales representatives assigned to promote the Juno Program Co-Co Product in such countries with [***] with respect to the promotion of Juno Program Co-Co Product necessary to [***] the Juno Program Co-Co Product in accordance with the terms of this Juno Lead Co-Co Agreement and applicable Law. Each Party agrees that none of its sales representatives involved in the promotion of the Juno Program Co-Co Product will have or be subject to any legal or regulatory disqualifications, debarments or sanctions. If the Commercialization Lead Party [***] with the other Party regarding [***] designated to be led by the other Party as the Commercialization Lead Party under this Article 3, such other Party will [***] consistent with the [***], which may include [***].

(vi) The calculation of costs of engaging sales representatives for purposes of calculating Operating Profits or Losses shall be [***], and such [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(c) Promotional Materials . Each Party’s sales representatives assigned to promote the Juno Program Co-Co Product in countries in which the other Party is the Commercialization Lead Party will utilize only promotional materials that have been approved by the Commercialization Lead Party for the applicable territory. All detailing activities conducted by such Party’s sales representatives will be consistent in all material respects with the promotional materials so approved. Each Party performing activities designated to be led by the other Party as the Commercialization Lead Party will train and instruct their respective sales representatives to make only those statements and claims regarding the Juno Program Co-Co Product, including as to efficacy and safety, that are consistent with the Juno Program Co-Co Product labeling and accompanying inserts and the approved promotional materials. For clarity, all marketing and promotional materials used in countries in which the other Party is the Commercialization Lead Party must be approved by the Commercialization Lead Party prior to use.

(d) Medical Affairs; Information . For Juno Program Co-Co Products in countries in which the non-Commercialization Lead Party provides Commercialization support to the Commercialization Lead Party, the Parties will discuss the execution of medical and scientific affairs and programs, including for professional symposia and other educational activities, and medical affairs studies based upon approved protocols, medical information support and medical communications and publishing activities, and the allocation of each Party to such activities in the Territory, provided [***] to the conduct of such activities in the Commercialization Lead Party’s territory. The Parties acknowledge that in such countries each Party may receive requests for medical information concerning the Juno Program Co-Co Product from members of the medical professions and consumers. [***] will have the [***] right to respond to questions and requests for information about Juno Program Co-Co Product received from such Persons that [***] or that are [***] (each such request, an “ Information Request ”) and that are [***], and [***] will have the [***] right to respond to an Information Request that is [***]. Any Information Request that is applicable to [***].

(e) Market Access Activities . [***], in consultation with the JCC, to develop plans for market access activities. For Juno Program Co-Co Products in countries in which the non-Commercialization Lead Party provides Commercialization support to the Commercialization Lead Party, each Party shall have the right to participate in the foregoing activities in accordance with the Juno Co-Co Commercialization Plan. For clarity, the costs related to such market access activities shall be [***].

(f) Reporting . Each Party will provide the JCC with a report, as soon as practicable but in no event later than [***] following the end of each Calendar Quarter commencing as of the date upon which the first Juno Program Co-Co Product has received Regulatory Approval in the Territory, or at such other time as the JCC deems appropriate, and continuing thereafter for each Calendar Quarter for the remainder of the Juno Co-Co Term for such Juno Program Co-Co Product, setting forth the number of details made by its sales representatives of Juno Program Co-Co Product during such Calendar Quarter. Costs and expenses for sales representatives will be [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(g) Records . Each Party will maintain records and otherwise establish procedures to ensure compliance with all applicable Laws and professional requirements that apply to the promotion and marketing of Juno Program Co-Co Product, including compliance with the PhRMA Code on Interactions with Healthcare Professionals.

3.1.8 Juno Co-Co Commercialization Budget .

(a) At such times as the JCC will deem appropriate, and in no event later than concurrently with the preparation of the initial Juno Co-Co Commercialization Plan, each Commercialization Lead Party will prepare an initial budget for Commercialization Activities with respect to Juno Program Co-Co Products for Celgene Territory Administration (in the case of Celgene), and for Juno Territory Administration (in the case of Juno). The JCC will review and approve such initial budgets for Commercialization in relation to Juno Program Co-Co Products, and such budgets shall collectively constitute the “ Juno Co-Co Commercialization Budget ”. Thereafter, each Commercialization Lead Party will update its portion of the Juno Co-Co Commercialization Budget at least once in each Calendar Year, (but in any event no later than [***] of each Calendar Year during the Juno Co-Co Term) and the JCC will review and approve any such update or any other amendment to the Juno Co-Co Commercialization Budget. In addition, either Party may request at any time that the JCC consider and approve other updates to the Juno Co-Co Commercialization Budget.

(b) Subject to subsection (a), all [***] arising from either Party’s [***] (including any [***]) in accordance with the Juno Co-Co Commercialization Plan and the Juno Co-Co Commercialization Budget shall be [***].

3.2 Additional Terms . In addition:

3.2.1 Role of the JCC . The JCC will coordinate the Parties’ efforts with respect to the Commercialization of Juno Program Co-Co Products in the Territory. Specifically, the JCC will oversee the development of global branding strategies for Juno Program Co-Co Products, coordinate training of sales representatives and others involved in Commercialization pursuant to Sections 3.1.7 and Exhibit F , and coordinate commercial supply of Juno Program Co-Co Products pursuant to this Juno Lead Co-Co Agreement.

3.2.2 Branding . If and at such time as the JCC deems appropriate, the JCC shall discuss in good faith any branding and/or co-branding of the Juno Program Co-Co Products to be used in connection with the Commercialization of Juno Program Co-Co Products both in the North America Territory and the ROW Territory, and the Parties will enter into appropriate trademark licensing agreements to achieve the foregoing. For the avoidance of doubt, nothing in this Juno Lead Co-Co Agreement shall be construed to grant either Party any rights in or to any of the other Party’s trademarks, trade names, logos, or other marks, including use thereof, absent a separate trademark licensing agreement entered into in accordance with this Section 3.2.2.

3.2.3 Commercialization Reports . Each Party will provide the JCC with a report, as soon as practicable but in no event later than [***] following the [***] setting forth a [***] on the status of its Commercialization Activities with respect to Juno Program Co-Co

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Products and Juno Program Co-Co Diagnostic Products, including [***] of Juno Program Co-Co Product in the Territory during [***] (a “ Juno Co-Co Commercialization Report ”), as well as the Commercialization Lead Party’s plans with respect to Commercialization of Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products during [***]. At [***] prior to the anticipated First Juno Program Co-Co Sale of a Juno Program Co-Co Product under this Juno Lead Co-Co Agreement anywhere in the North America Territory or the ROW Territory, the JCC shall discuss and agree upon the form and content for such Juno Co-Co Commercialization Report. Such Juno Co-Co Commercialization Report shall also describe in reasonable detail, for each country(ies) in which a Party is co-Commercializing Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products, [***].

ARTICLE 4

EXCLUSIVITY

4.1 Exclusivity . Article 5 of the Master Collaboration Agreement shall apply to the Parties’ activities under this Juno Lead Co-Co Agreement, in each case to the extent applicable to the Juno Co-Co Program that is the subject of this Juno Lead Co-Co Agreement, for the time periods, and to the extent expressly set forth therein.

ARTICLE 5

FINANCIAL TERMS

5.1 Option Exercise and Designation Payments . In partial consideration for the rights and licenses granted by Juno pursuant to this Juno Lead Co-Co Agreement, in connection with the execution of this Juno Lead Co-Co Agreement:

5.1.1 BD Programs .

(a) If the Juno Co-Co Program is an [***], then Celgene shall pay to Juno the amount set forth in Paragraph 1(a) of Exhibit C in accordance with the payment terms set forth therein; and

(b) If the Juno Co-Co Program is an [***], then Celgene shall pay to Juno the amount set forth in Paragraph 1(e) of Exhibit C in accordance with the payment terms set forth therein.

(c) If the Juno Co-Co Program is a [***], then Juno shall pay to Celgene the amount set forth in Paragraph 1(f) of Exhibit C in accordance with the payment terms set forth therein.

5.1.2 Celgene Co-Promote Programs . If the Juno Co-Co Program is a [***], then Celgene shall pay to Juno one of the amounts set forth in Paragraph 1(c), (d) or (e) of Exhibit C , as applicable, with the amount and timing of such payment [***].

5.1.3 [***] Program . If the Juno Co-Co Program is an [***] Program, then Celgene shall pay to Juno the amounts set forth in Paragraph 1(b) or 1(d) of Exhibit C , as applicable, with the amount and timing of such payment [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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5.2 Profit & Loss Share for Juno Program Co-Co Product . The Parties will share in Operating Profits or Losses with respect to Juno Program Co-Co Products in the Territory as follows: Juno will bear (and be entitled to) [***], and Celgene will bear (and be entitled to) [***] (each Party’s share of Operating Profits or Losses, the “ Profit & Loss Share ”). Procedures for reporting of actual results on a Calendar Quarter basis, review and discussion of potential discrepancies, reconciliation on a Calendar Quarter basis, reasonable forecasting, and other finance and accounting matters, are set forth in Exhibit D , and to the extent not set forth in Exhibit D , will be established by the JCC, subject to Section 5.4.3.

5.3 Discounted Sales .. It is possible that a Juno Program Co-Co Product could be included as part of a package of products offered to customers by either Party or its Affiliates or Sublicensees, and that discounts on packages including a Juno Program Co-Co Product (a “ Package ”) may be offered in the Territory. [***].

5.4 Additional Payment Terms .

5.4.1 Accounting . All payments hereunder shall be made in the United States in U.S. Dollars by wire transfer to a bank in the U.S. designated in writing by Juno. Conversion of sales recorded in local currencies to Dollars shall be performed in a manner consistent with [***].

5.4.2 Late Payments . Any payments or portions thereof due hereunder that are not paid on the date such payments are due under this Juno Lead Co-Co Agreement shall bear interest at an annual rate equal to the lesser of: (a) [***], or any successor thereto, at 12:01 a.m. on the first day of each Calendar Quarter in which such payments are overdue or (b) the maximum rate permitted by applicable Law; in each case calculated on the number of days such payment is delinquent, compounded monthly.

5.4.3 Tax Withholding .

(a) The Parties acknowledge that the rights and obligations imposed on each of them pursuant to this Juno Lead Co-Co Agreement that [***] [***] to the Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products and the [***] in connection therewith, [***], and the Parties shall act in accordance with Exhibit H . By execution of this Juno Lead Co-Co Agreement, the Parties hereto intend that the [***], which shall be reflected in the [***] for each such region in accordance with Section 9.4.1(e)(i) of the Master Collaboration Agreement.

(b) Each Party shall be entitled to deduct and withhold from any amounts payable under this Juno Lead Co-Co Agreement (or allocable to another Party pursuant to Section 1.6 of Exhibit H ) such taxes as are required to be deducted or withheld therefrom under any provision of applicable Law. The Party that is required to make such withholding (the “ Paying Party ”) will: (i) deduct those taxes from such payment, (ii) timely remit the taxes to the proper taxing authority, and (iii) send evidence of the obligation together with proof of tax

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

31


payment to the recipient Party (the “ Payee Party ”) on a timely basis following that tax payment; provided, however, that before making any such deduction or withholding, the Paying Party shall give the Payee Party notice of the intention to make such deduction or withholding (such notice, which shall include the authority, basis and method of calculation for the proposed deduction or withholding, shall be given at least a reasonable period of time before such deduction or withholding is required, in order for such Payee Party to obtain reduction of or relief from such deduction or withholding); and provided, further, that in the event the relevant withholding tax is imposed with respect to an amount allocable pursuant to Section 1.6 of Exhibit H but the amount of any cash payment otherwise due to the Payee Party is either unavailable or insufficient for the Paying Party to be able to deduct the full amount of such withholding taxes, the Payee Party shall indemnify the Paying Party from and against such withholding taxes. Each Party agrees to cooperate with the other Parties in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect to ensure that any amounts required to be withheld pursuant to this Section 5.4.3(b) are reduced in amount to the fullest extent permitted by applicable Laws. In addition, the Parties shall cooperate in accordance with applicable Laws to [***] in connection with this Juno Lead Co-Co Agreement.

(c) In the event that a liability is imposed by a taxing authority upon the Paying Party in respect of a failure to withhold on an amount payable under this Juno Lead Co-Co Agreement, the Payee Party shall indemnify and hold harmless the Paying Parties from any and all liabilities, claims and losses with respect to such failure to withhold, provided that (1) the Paying Party shall notify the Payee Party promptly upon the receipt of any claim from a taxing authority which might give rise to an indemnification under this Section 5.4.3(c) (although the Paying Party’s delay in promptly notifying the Payee Party shall only reduce the Payee Party’s liability to indemnify the Paying Party to the extent that the Payee Party is prejudiced by such delay); (2) the Payee Party shall be entitled to participate, at its own expense, and with counsel of its choosing, in the defense of any claim which may give rise to liability under this Section 5.4.3(c); and (3) the Paying Party may not settle any liability with a taxing authority, to the extent such settlement would create a liability for the Payee Party under this Section 5.4.3(c), without the prior written consent of the Payee Party, which consent will not be unreasonably withheld, conditioned or delayed.

ARTICLE 6

INTELLECTUAL PROPERTY

6.1 License .

6.1.1 License to Celgene . Subject to the terms and on the conditions set forth in this Juno Lead Co-Co Agreement, and solely with respect to the Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products that are the subject of this Juno Lead Co-Co Agreement, Juno hereby grants and shall cause (within [***] after the Juno Lead Co-Co Agreement Effective Date) its Affiliates to grant to Celgene (a) an exclusive (even as to Juno and its Affiliates, [***], royalty-free right and license, with the right to grant sublicenses [***] (subject to Section 6.1.3), under (i) the Juno Program Co-Co IP, (ii) Juno’s and its Affiliates’ rights in the Collaboration IP, and (iii) Juno’s and its Affiliates’

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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interest in the Joint Collaboration IP, and (b) a non-exclusive, royalty-free right and license, with the right to grant sublicenses (subject to Section 6.1.3), under Patents and Know-How [***], in each case of (a) and (b) [***] (A) to conduct Research, Development, Manufacture (as set forth in the Manufacturing Agreement, if applicable), and Commercialization Activities for Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products in the Field in the ROW Territory for Celgene Territory Administration in accordance with the Juno Co-Co Development Plan and/or Juno Co-Co Commercialization Plan, and (B) if Celgene has delivered a Celgene Co-Commercialization Notice pursuant to Section 3.1.2, to conduct Commercialization Activities [***] in the North America Territory for Juno Territory Administration. Juno shall [***] upon written notice to Celgene [***]; provided that (a) [***], (b) [***], and (c) [***].

6.1.2 License to Juno . Subject to the terms and on the conditions set forth in this Juno Lead Co-Co Agreement, and solely with respect to the Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products that are the subject of this Juno Lead Co-Co Agreement, Celgene hereby grants and shall cause (within [***] after the Juno Lead Co-Co Agreement Effective Date) its Affiliates to grant to Juno (a) an exclusive (even as to Celgene and its Affiliates, [***] to Research, Develop, Manufacture and Commercialize Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products [***], royalty-free right and license, with the right to grant sublicenses [***] (subject to Section 6.1.3), under (i) the Celgene Relevant Co-Co IP, (ii) Celgene’s and its Affiliates’ rights in the Collaboration IP, and (iii) Celgene’s and its Affiliates’ interest in the Joint Collaboration IP, and (b) a non-exclusive, royalty-free right and license, with the right to grant sublicenses (subject to Section 6.1.3), under Patents and Know-How [***], in each case of (a) and (b) [***] (A) to conduct Research, Development, Manufacture [***] and Commercialization Activities for Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products in the Field (1) [***] in accordance with the Juno Co-Co Development Plan and/or Juno Co-Co Commercialization Plan, and (2) in the China Territory, and (B) if Juno has exercised the Commercialization Opt-In Right pursuant to Section 3.1.3, for Juno to conduct Commercialization Activities [***] for ROW Territory Administration in the Major EU Market Countries. Celgene shall [***] upon written notice to Juno [***]; provided that (a) [***], (b) [***], and (c) [***].

6.1.3 Sublicenses .

(a) Celgene shall have the right to grant sublicenses within the scope of the license granted to Celgene under Section 6.1.1 as follows: (i) with respect to the right and license granted to Celgene under Section 6.1.1(a), [***], (ii) with respect to the right and license granted to Celgene under 6.1.1(b), [***], and (iii) otherwise [***].

(b) Juno shall have the right to grant sublicenses within the scope of the license granted to Juno under Section 6.1.2 as follows: (i) with respect to the right and license granted to Juno under Section 6.1.2(a), [***], (ii) with respect to the right and license granted to Juno under Section 6.1.2(b), [***], and (iii) otherwise [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(c) Each sublicense granted by either Party under this Section 6.1.3 shall be subject to and consistent with the terms and conditions of this Juno Lead Co-Co Agreement. If a Party grants a sublicense to any Third Party under Section 6.1.3(a)(ii) or (iii) or Section 6.1.3(b)(ii) or (iii), it shall [***].

6.1.4 Rights Retained by the Parties . For purposes of clarity, each Party retains the rights under Know-How and Patents Controlled by such Party not expressly granted to the other Party pursuant to this Juno Lead Co-Co Agreement.

6.1.5 No Implied Licenses . Except as explicitly set forth in this Juno Lead Co-Co Agreement, neither Party shall be deemed by estoppel or implication to have granted the other Party any license or other right to any intellectual property of such Party.

6.1.6 Section 365(n) of the Bankruptcy Code . All licenses granted under this Juno Lead Co-Co Agreement are deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as defined in Section 101 of such Code. Each Party, as licensee, may fully exercise all of its rights and elections under the Bankruptcy Code. The Parties further agree that, if a Party elects to retain its rights as a licensee under any Bankruptcy Code, such Party shall be entitled to complete access to any technology licensed to it hereunder and all embodiments of such technology. Such embodiments of the technology shall be delivered to the licensee Party not later than: (a) the commencement of bankruptcy proceedings against the licensor, upon written request, unless the licensor elects to perform its obligations under this Juno Lead Co-Co Agreement, or (b) if not delivered under Section 6.1.6(a), upon the rejection of this Juno Lead Co-Co Agreement by or on behalf of the licensor, upon written request. Any agreements supplemental hereto will be deemed to be “agreements supplementary to” this Juno Lead Co-Co Agreement for purposes of Section 365(n) of the Bankruptcy Code.

6.2 Ownership .

6.2.1 Inventorship . Inventorship of Inventions shall be determined by application of U.S. patent law pertaining to inventorship.

6.2.2 Ownership . Ownership of Inventions and intellectual property rights therein arising from each of the Parties’ activities under this Juno Lead Co-Co Agreement shall be determined in accordance with Sections 7.2.2, 7.2.3, 7.2.4 and 7.2.5 of the Master Collaboration Agreement.

6.2.3 Cooperation and Allocation . Sections 7.2.6, 7.2.7 and 7.2.8 of the Master Collaboration Agreement shall apply to all Inventions and intellectual property rights therein, that arise in whole or in part as a result of the Parties’ activities under this Juno Lead Co-Co Agreement.

6.3 Prosecution and Maintenance of Patents . Subject to Section 6.7, Prosecution and Maintenance of all Patents directed to any Inventions [***] pursuant to this Juno Lead Co-Co Agreement shall be carried out in accordance with Section 7.3 of the Master Collaboration

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Agreement. Additionally, Celgene shall keep Juno informed as to [***] with respect to the Prosecution and Maintenance of Patents licensed to Juno under Section 6.1.2(a), and Juno shall keep Celgene informed as to [***] with respect to the Prosecution and Maintenance of Patents licensed to Celgene under Section 6.1.1(a). Celgene [***] with respect to any Patent Controlled by Celgene licensed to Juno under Section 6.1.2(a), and Juno shall [***] with respect to any Patent Controlled by Juno licensed to Celgene under Section 6.1.1(a).

6.4 Defense of Claims Brought by Third Parties .

6.4.1 Notice . If a Party becomes aware of any actual or potential claim alleging that the Research, Development, Manufacture or Commercialization of the Juno Program Co-Co Target, any Juno Program Co-Co Candidate, any Juno Program Co-Co Product or any Juno Program Co-Co Diagnostic Product, does (or would if carried out) infringe the intellectual property rights of any Third Party anywhere in the North America Territory or the ROW Territory, such Party shall [***]. In any such instance, the Parties shall [***].

6.4.2 Costs . The costs and expenses incurred by the Parties in connection with defense of any claim described in Section 6.4.1 shall be [***] and shall be [***], unless otherwise agreed in writing by the Parties.

6.5 Enforcement of Patents .

6.5.1 Notice . If any Party learns of an infringement or suspected or threatened infringement by a Third Party with respect to any Patent licensed to Celgene pursuant to Section 6.1.1 or a Patent that is licensed to Juno pursuant to Section 6.1.2, including actual or alleged infringement under 35 USC §271(e)(2) that is or would be infringing activity involving the using, making, importing, offering for sale or selling of compounds or products that are substantially the same as Juno Program Co-Co Candidates, Juno Program Co-Co Products or Juno Program Co-Co Diagnostic Products (“ Juno Program Co-Co Competitive Infringement ”), such Party shall [***] and [***] such Juno Program Co-Co Competitive Infringement. For any Juno Program Co-Co Competitive Infringement, each Party shall [***].

6.5.2 Scope of Enforcement Rights . As between the Parties, and subject to Sections 6.5.3, 6.5.4, 6.7 and 6.8:

(a) Celgene shall have the [***], to institute, prosecute, and control any action or proceeding with respect to any Juno Program Co-Co Competitive Infringement occurring in the [***], and Juno shall have the [***], to institute, prosecute, and control any action or proceeding with respect to any Juno Program Co-Co Competitive Infringement occurring in [***], in each case of any Patent (i) that [***], and (ii) that (A) [***], or (B) is (1) included in the [***], and (2) [***] (the Patents in this Section 6.5.2(a), the “ Juno Program Co-Co Product Patents ”).

(b) With respect to any Patent that is not a Juno Program Co-Co Product Patent and (i) that (A) [***], and (B) is (1) included in [***], or (2) included in [***], or (ii) that does not [***], and (A) is included in [***] or (B) (1) is included in [***] and (2) [***], then in

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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each of (i) and (ii), (x) [***] to institute, prosecute, and control any action or proceeding with respect to any Juno Program Co-Co Competitive Infringement in [***], and (y) [***] institute, prosecute, or control any action or proceeding with respect to any Juno Program Co-Co Competitive Infringement in [***].

(c) With respect to any Patent that is not a Juno Program Co-Co Product Patent and (i) that (A) [***], and (B) is (1) included in [***], or (2) included in [***], or (ii) that does not [***], and (A) is included in [***], or (B) (1) is included [***] and (2) [***], in each of (i) and (ii), (x) [***] institute, prosecute, and control any action or proceeding with respect to any Juno Program Co-Co Competitive Infringement in [***], and (y) [***] institute, prosecute, or control any action or proceeding with respect to any Juno Program Co-Co Competitive Infringement in the [***].

(d) With respect to any Patent that does not [***] Juno Program Co-Co Candidates, Juno Program Co-Co Products, or Juno Program Co-Co Diagnostic Products, [***], or (ii) (A) is [***], (B) is included in [***], and (C) does not [***], in each of (i) and (ii), [***] institute, prosecute, and control any action or proceeding with respect to any Juno Program Co-Co Competitive Infringement relating to such Patent in the ROW Territory and the North America Territory, [***].

(e) With respect to any Patent that does not [***] Juno Program Co-Co Candidates, Juno Program Co-Co Products, or Juno Program Co-Co Diagnostic Products, [***] and that (i) is [***], or (ii) (A) is [***], and (C) does not [***], in each of (i) and (ii), [***] institute, prosecute and control any action or proceeding with respect to any Juno Program Co-Co Competitive Infringement relating to such Patent in the ROW Territory and the North America Territory, [***].

(f) With respect to any Patent that is jointly owned by the Parties and is included in the Collaboration IP or the Joint Collaboration IP (excluding any Juno Program Co-Co Product Patent and excluding any Patent that Covers or claims the [***]:

(i) that [***], to institute, prosecute, and control any action or proceeding with respect to any Juno Program Co-Co Competitive Infringement occurring in [***], and [***], to institute, prosecute, and control any such action or proceeding with respect to any Juno Program Co-Co Competitive Infringement occurring in the [***], provided that [***]; and

(ii) that [***] Juno Program Co-Co Candidates, Juno Program Co-Co Products, or Juno Program Co-Co Diagnostic Products, or the [***]

(g) Unless otherwise agreed by the parties, and subject to Sections 6.5.3 and 6.5.4, any rights granted to either Party to institute, prosecute, and control any action or proceeding with respect to any Juno Program Co-Co Competitive Infringement under Sections 6.5.2(a)-(f) are, in each case by counsel of the enforcing Party’s own choice, in such Party’s own name and under such Party’s direction and control, provided that with respect to any such action or proceeding in relation to Juno Program Co-Co Candidates, Juno Program Co-Co Products or

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Juno Program Co-Co Diagnostic Products, the enforcing Party shall keep the other Party, through the Patent Committee, reasonably informed as to the status of, and all material developments in such action, and shall [***]. Such rights granted to such Party shall include, if applicable, the right to perform, with respect to such actions with respect to Juno Program Co-Co Competitive Infringement, solely in the country(ies) in which the enforcement action is proceeding, all actions of a reference product sponsor or equivalent set forth in the Hatch-Waxman Act or Public Health Service Act (or any ex-U.S. equivalent of the either of the foregoing), to the to the extent permitted by applicable Law, and if the enforcing Party is limited in performing such actions, the other Party shall reasonably cooperate to enable the enforcing Party to perform such actions.

6.5.3 Timing . The Party with the first right (and for clarity, not the sole right) to institute, prosecute, and control any action or proceeding with respect to any Patent described in Section 6.5.1 and involving Juno Program Co-Co Competitive Infringement (each such action or proceeding, a “ Juno Program Co-Co Enforcement Proceeding ”) will have a period of [***] after its receipt or delivery of notice and evidence pursuant to Section 6.5.1 or receipt of written notice from a Third Party that reasonably evidences Juno Program Co-Co Competitive Infringement, to elect to so enforce the relevant Patent(s) in the applicable jurisdiction (or to settle or otherwise secure the abatement of such Juno Program Co-Co Competitive Infringement), provided however, that such period will be (a) more than [***] to the extent applicable Law prevents earlier enforcement of such Patent (such as the enforcement process set forth in or under the Hatch-Waxman Act or Public Health Service Act (or any ex-U.S. equivalent of either of the foregoing)), and provided further that if such period is extended because applicable Law prevents earlier enforcement, the enforcing Party shall have until the date that is [***] following the date upon which applicable Law first permits such Juno Program Co-Co Enforcement Proceeding, and (b) less than [***] to the extent that a delay in bringing such Juno Program Co-Co Enforcement Proceeding against such alleged Third Party infringer would limit or compromise the remedies (including monetary relief, and stay of regulatory approval) available against such alleged Third Party infringer. In the event the enforcing Party [***] before the first to occur of (i) the expiration of the applicable period of time set forth in the preceding subsections (a) and (b), or (ii) [***] before the expiration of any time period under applicable Law, that would, if a Juno Program Co-Co Enforcement Proceeding was not filed within such time period, limit or compromise the remedies available from such Juno Program Co-Co Enforcement Proceeding, it will [***] and in the case where such other Party then [***] the applicable Patent with respect to such Juno Program Co-Co Competitive Infringement in the applicable jurisdiction, such other Party will thereafter have the right to commence such a suit or take such action to enforce the applicable Patent (such action, a “ Juno Program Co-Co Step-In Proceeding ”) at such other Party’s expense.

6.5.4 Sole Enforcement and Defense for [***] . Notwithstanding anything to the contrary herein, with respect to any Juno Program Co-Co Competitive Infringement:

(a) [***]; and

(b) [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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6.5.5 Right to Participate; Joinder . The non-enforcing Party in relation to any enforcement action or proceeding set forth in Section 6.5.2 or 6.5.4, will have the right, at its own expense and by counsel of its choice, to be represented in, or participate in any such action or proceeding. In the case of any Juno Program Co-Co Enforcement Proceeding or Juno Program Co-Co Step-In Proceeding, at the enforcing Party’s written request, and at the enforcing Party’s expense (subject to Section 6.5.9), the other Party will join any such action or proceeding as a party and will use Commercially Reasonable Efforts to cause any Third Party as necessary to join such action or proceeding as a party if doing so is necessary for the purposes of establishing standing or is otherwise required by applicable Law to pursue such action or proceeding. All time periods set forth in Section 6.5.3 shall be subject to applicable Law, which may prevent earlier enforcement.

6.5.6 Cooperation . In addition to the obligations set forth in Sections 6.5.2(a) and 6.5.5, each other Party will provide to the Party enforcing any such rights under Section 6.5.2(a) reasonable assistance and cooperation in such enforcement, at such enforcing Party’s request and expense. The enforcing Party will keep the other Party regularly informed of the status and progress of such enforcement efforts. The Parties will coordinate any Juno Program Co-Co Enforcement Proceeding through the Patent Committee. Each Party bringing any such action or proceeding in accordance with this Section 6.5 shall have an obligation to consult with the other Party and will take comments of such other Party into good faith consideration with respect to the infringement, claim construction, or Defense of the validity or enforceability of any claim in any Patent that is the subject of such proceeding, provided that the foregoing shall not apply to any such action or proceeding as it relates to (i) [***], or (ii) [***]. Only with respect to any Patent within the [***] that [***], the Parties shall [***].

6.5.7 Third Party Rights . Notwithstanding Sections 6.5.2(a) through 6.5.6, each Party’s rights to enforce a Patent pursuant to this Section 6.5, or to Defend against a challenge in any action or proceeding described in Section 6.4, shall be subject to the applicable provisions of any agreements between a Party and its licensor(s) of such Patent. In the event of any conflict between this Section 6.5 and such other agreements between a Party (and/or its Affiliates) and its/their licensor(s), the provisions of such other agreements shall control.

6.5.8 Inter Partes Review and Re-Examination Proceedings . If either Party becomes aware of any actual or potential inter partes review, re-examination or post grant review proceedings (but excluding [***]) involving any [***], such Party shall so notify the other Party. The Party having the right to bring an enforcement action pursuant to this Section 6.5 with respect to such Patent shall have the right to assume responsibility for the Defense thereof, with the other Party having backup rights therefor to the extent provided to such Party in the context of an action to enforce such Patent, with the costs of such action [***]. If neither Party has a right to bring an enforcement action pursuant to this Section 6.5 with respect to such Patent, then the Party Controlling such Patent shall have the right to assume responsibility for the Defense thereof.

6.5.9 Settlement . A settlement or consent judgment or other voluntary final disposition of a suit or proceeding under this Section 6.5 may be entered into by one Party

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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without the consent of the other Party not bringing or Defending such action or proceeding; provided, however, that any such settlement, consent judgment or other disposition of any action or proceeding by the Party under this Section 6.5 shall not, without the consent of such other Party, (a) [***] the Party not bringing or Defending such action or proceeding, (b) include the [***] the Party not bringing or Defending such action or proceeding [***], (c) [***] the Party not bringing or Defending such action or proceeding, or (d) [***] the Party not bringing or Defending such action or proceeding [***].

6.5.10 Costs and Recoveries . Except as otherwise set forth in this Section 6.5, each Party shall [***] in connection with its activities under this Section 6.5. If a Party commences a Juno Program Co-Co Enforcement Proceeding or any or any other action or proceeding with respect to any Juno Program Co-Co Competitive Infringement occurring in the Territory or Defends an action under this Section 6.5, [***] for such action or proceeding. All [***] in pursuing any Juno Program Co-Co Enforcement Proceeding in accordance with this Section 6.5 shall be [***]. Any damages or other monetary awards recovered in any action, suit or proceeding brought under this Section 6.5 shall be shared as follows:

(a) the amount of such damages or other sums actually received by the Party controlling such action shall first be subject to Article 8, and then shall be applied to reimburse all out-of-pocket costs and expenses incurred by each Party directly in connection with such action (including, for this purpose, [***]), and if such recovery is insufficient to cover all such costs and expenses of both Parties, it shall be [***]; and

(b) any remaining proceeds in case of suits with respect to a Juno Program Co-Co Enforcement Proceeding or any or any other action or proceeding with respect to any Juno Program Co-Co Competitive Infringement occurring in the North America Territory or the ROW Territory relating to any Juno Program Co-Co Candidate, Juno Program Co-Co Product or Juno Program Co-Co Diagnostic Product under this Section 6.5 shall be [***].

6.6 Patent Term Extensions .

6.6.1 If, during the Juno Co-Co Term, either Party wishes to apply for or obtain any patent term extensions, restorations, or supplementary protection certificates (in each case based on delays or activities associates with seeking Regulatory Approval) under applicable Laws (such extensions, restorations and certificates, collectively, “ Patent Term Extensions ) for a Patent [***] any Juno Program Co-Co Candidate, Juno Program Co-Co Product or associated Juno Program Co-Co Diagnostic Product [***], and that [***] (“ Juno Program Co-Co Covering Patent ”), in the North America Territory or the ROW Territory, subject to Section 6.6.3, then Section 7.6 of the Master Collaboration Agreement shall apply to determine whether such Patent Term Extension shall be sought or obtained, provided that if the Parties are unable to reach mutual agreement regarding whether to seek or obtain such Patent Term Extension then the following shall apply:

(a) if such Juno Program Co-Co Covering Patent is [***], then notwithstanding anything to the contrary in Section 7.6 of the Master Collaboration Agreement, [***] shall have the right to make the final decision as to whether such Patent Term Extension

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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shall be sought or obtained in the [***] Territory and [***] shall have the right to make the final decision as to whether such Patent Term Extension shall be sought or obtained in the [***] Territory;

(b) if such Juno Program Co-Co Covering Patent (i) [***] Juno Program Co-Co Candidates, Juno Program Co-Co Products or Juno Program Co-Co Diagnostic Products, [***] and (ii) (A) is included in [***] or (B) is (1) included in [***] and (2) [***], then (x) if such Juno Program Co-Co Covering Patent is [***], then in the North America Territory, [***], and in the ROW Territory, [***], and (y) if such Juno Program Co-Co Covering Patent is [***], then in the ROW Territory, [***], and in the North America Territory, [***];

(c) if such Juno Program Co-Co Covering Patent is [***], then if such Juno Program Co-Co Covering Patent:

(i) is (A) [***] or (B) [***], then (1) in the [***] Territory, [***] may seek or obtain a Patent Term Extension for such Juno Program Co-Co Covering Patent [***], and (2) in the [***] Territory, [***] seek or obtain a Patent Term Extension for such Juno Program Co-Co Covering Patent;

(ii) is (A) [***] or (B) [***], then (1) in the [***] Territory, [***] may seek or obtain a Patent Term Extension for such Juno Program Co-Co Covering Patent, [***], and (2) in the [***] Territory, [***] a Patent Term Extension for such Juno Program Co-Co Covering Patent;

(d) if such Juno Program Co-Co Covering Patent is [***] and is [***], then [***] may seek or obtain a Patent Term Extension for such Juno Program Co-Co Covering Patent in the [***]; and

(e) if such Juno Program Co-Co Covering Patent [***], then if such Juno Program Co-Co Covering Patent:

(i) is (A) [***] or (B) [***], then (1) in the [***] Territory,[***] shall have the right to make the final decision on whether to seek or obtain a Patent Term Extension for such Juno Program Co-Co Covering Patent, and (2) in the [***] Territory, [***] shall have the right to make a final decision with respect to such Patent Term Extension, provided that [***]; or

(ii) is (A) [***] or (B) [***], then (1) in the [***] Territory, [***] shall have the right to make the final decision on whether to seek or obtain a Patent Term Extension for such Juno Program Co-Co Covering Patent, and (2) in the [***] Territory, [***] shall have the right to make a final decision with respect to such Patent Term Extension, provided that [***].

6.6.2 Notwithstanding anything to the contrary herein or in the Master Collaboration Agreement, Juno shall have no right to seek or obtain Patent Term Extension, without Celgene’s prior written consent, for any Patent [***]; and Celgene have no right to seek or obtain Patent Term Extension, without Juno’s prior written consent, for any Patent [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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6.7 [***] . Notwithstanding anything to the contrary in Sections 6.3 through 6.6, or in the Master Collaboration Agreement, (a) in no event shall [***] and (b) [***].

6.8 [***] Patents . Section 7.8 of the Master Collaboration Agreement shall apply.

6.9 Regulatory Data Protection . To the extent required or permitted by applicable Law, the Commercialization Lead Party in a given country will use Commercially Reasonable Efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities in such country during the Juno Co-Co Term, all applicable Patents for any Juno Program Co-Co Product that the Commercialization Lead Party [***], Commercialize, such listings to include all so called “Orange Book” listings required under the U.S. Hatch-Waxman Act or the equivalent thereof outside of the U.S., if applicable. Prior to such listings, the Parties will [***] all applicable Patents. Notwithstanding the preceding sentence, the Commercialization Lead Party in a country will [***] as to the listing of all applicable Patents for such Juno Program Co-Co Product, regardless of [***] such Patent.

6.10 Third Party Licenses . If, at any time during the Juno Co-Co Term, a Party [***] that any Third Party intellectual property rights are [***] the Development, Manufacture or Commercialization of any Juno Program Co-Co Product or Juno Program Co-Co Candidate, that is the subject of Research, Development, Manufacture and/or Commercialization efforts under this Juno Lead Co-Co Agreement, then such [***], and Section 7.9 of the Master Collaboration Agreement shall apply. Any amounts due pursuant to any agreement entered into pursuant to Section 7.9 of the Master Collaboration Agreement [***].

ARTICLE 7

UPSTREAM AGREEMENTS

7.1 Upstream Obligations . Celgene and Juno each acknowledge and agree that all licenses granted under this Juno Lead Co-Co Agreement, to the extent they constitute sublicenses under intellectual property rights owned by a Third Party and licensed or sublicensed to a Party under a Juno Upstream Agreement, or a Celgene Upstream Agreement, as applicable, and licensed to the other Party pursuant to this Juno Lead Co-Co Agreement are subject to the relevant terms and conditions of the Juno Upstream Agreements and/or the Celgene Upstream Agreements, as applicable. Any exclusive licenses that are granted under this Juno Lead Co-Co Agreement that constitute sublicenses under the Juno Upstream Agreements or the Celgene Upstream Agreements, as applicable are exclusive only to the extent of the exclusive nature of the license granted to Juno or Celgene under the Juno Upstream Agreements or the Celgene Upstream Agreements, as applicable.

ARTICLE 8

INDEMNIFICATION; INSURANCE

8.1 Indemnification by Celgene . Celgene shall indemnify, defend and hold harmless the Juno Indemnitees, from and against any and all Damages to the extent arising out of

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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or relating to, directly or indirectly, any Claim based upon:

(a) the [***] this Juno Lead Co-Co Agreement; or

(b) any [***] this Juno Lead Co-Co Agreement;

provided however that in each case, such indemnity shall not apply to the extent Juno has an indemnification obligation pursuant to Section 8.2 for such Damages.

8.2 Indemnification by Juno . Juno shall indemnify, defend and hold harmless the Celgene Indemnitees, from and against any and all Damages to the extent arising out of or relating to, directly or indirectly, any Claim based upon:

(a) the [***] this Juno Lead Co-Co Agreement;

(b) any [***] this Juno Lead Co-Co Agreement;

(c) any [***], in each case, resulting from any of the foregoing activities described in this Section 8.2(c);

provided however that in each case, such indemnity shall not apply to the extent Celgene has an indemnification obligation pursuant to Section 8.1 for such Damages.

8.3 Notice of Claims . A Claim to which indemnification applies under Section 8.1 or Section 8.2 shall be referred to herein as an “ Indemnification Claim .” If the Indemnitee intends to claim indemnification under this Article 8, the Party claiming indemnification (the “ Indemnitee ”) shall notify the indemnifying Party (the “ Indemnitor ”) in writing, promptly upon becoming aware of an Indemnification Claim, describing in reasonable detail the facts giving rise to the Indemnification Claim; provided, that an Indemnification Claim in respect of any action at law or suit in equity by or against a Third Party as to which indemnification shall be sought shall be given promptly after the action or suit is commenced (provided that the Indemnitee is aware of such commencement); and provided further, that the failure by an Indemnitee to give such notice shall not relieve the Indemnitor of its indemnification obligation under this Juno Lead Co-Co Agreement except and only to the extent that the Indemnitor is actually prejudiced as a result of such failure to give notice.

8.4 Indemnification Procedures . If an Indemnitee receives written notice of a Claim that the Indemnitee believes may result in a claim for indemnification under this Article 8, such Indemnitee shall deliver an Indemnification Claim to the Indemnitor in accordance with the provisions of Section 8.3. If the [***], then the Indemnitor shall have the right to assume and control the defense of the Claim, at its own expense with counsel selected by it and reasonably acceptable to the Indemnitee, by delivering written notice of its assumption of such defense to the Indemnitee within [***] of its receipt of notice of such Claim from the Indemnitor (but the Indemnitor shall in any event have the right to assume and control the defense of a Claim [***], whichever is first); provided, however, that the Indemnitee shall have the right to retain its own counsel, with the reasonable fees and expenses to be paid by the Indemnitor, if (a) representation

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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of the Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential conflict of interests between such Indemnitee and Indemnitor, (b) the Indemnitor has failed within a reasonable time to retain counsel, (c) the Indemnitee shall have reasonably concluded that there may be legal defenses available to it that are different from or in addition to those available to the Indemnitor, or (d) [***]. If the Indemnitor assumes and controls the defense of such Claim, the Indemnitor shall keep the Indemnitee reasonably apprised of the status of the Claim and the Indemnitee shall be entitled to otherwise monitor such Claim at its sole cost and expense. If the Claim [***] against or from the Indemnitee or if the Indemnitor does not assume the defense of the Claim as described in this Section 8.4, the Indemnitee shall be permitted to assume and control the defense of such Claim (but shall have no obligation to do so) and in such event shall be entitled to settle or compromise the Indemnification Claims in its sole and reasonable discretion, provided that if the Indemnitee is entitled to assume the defense of the Claim pursuant to this Section 8.4 solely because the Claim [***] against or from the Indemnitee, then the Indemnitee shall not settle or compromise such Indemnification Claims in any manner that involves [***] without the prior written consent of the Indemnitor, which consent the Indemnitor shall not unreasonably withhold, condition or delay. If the Indemnitor has assumed and controls the defense of the Claim in accordance with this Section 8.4, (i) the Indemnitee shall not settle or compromise the Indemnification Claim without the prior written consent of the Indemnitor, such consent not to be unreasonably withheld, conditioned or delayed and (ii) the Indemnitor shall not settle or compromise the Indemnification Claim in any manner that would result in the payment of amounts by the Indemnitee, impose any other obligation on the Indemnitee or otherwise have an adverse effect on the Indemnitee’s rights or interests (including any rights under this Juno Lead Co-Co Agreement or the Equity Purchase Agreement or the scope or enforceability of any Patents or Know-How licensed by one Party to another Party pursuant to this Juno Lead Co-Co Agreement or any other Development & Commercialization Agreement, or the Master Collaboration Agreement), without the prior written consent of the Indemnitee. In each case, the Party that is not controlling the defense of any Claim shall reasonably cooperate with the Party that is controlling the defense of such Claim, at the non-controlling Party’s expense and shall make available to the controlling Party all pertinent information under the control of the non-controlling Party, which information shall be subject to Article 8 of the Master Collaboration Agreement. Each Party shall use commercially reasonable efforts to avoid production of Confidential Information of the other Party (consistent with applicable Law and rules of procedure), and to cause all communications among employees, counsel and other representatives of such Party to be made so as to preserve any applicable attorney-client or work-product privileges.

8.5 Juno Co-Co Program Administration Liabilities . In the event that either Party (a) incurs any [***] relating thereto, or (b) is required to [***], and such liabilities in (a) and (b) the Juno Co-Co Product Administration Liabilities ”), such Juno Co-Co Product Administration Liabilities arising from or occurring as a result of the performance, [***], of the Development, Manufacture or Commercialization of Juno Program Co-Co Product or Juno Program Co-Co Diagnostic Product for Combined Territory Administration in accordance with this Juno Lead Co-Co Agreement will be charged to Operating Profits or Losses under the Profit & Loss Share, provided that Operating Profit or Loss will not include Combined Territory Administration Liabilities of a Party or its Affiliates: (i) that are caused by [***]; (ii) incurred

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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with respect to or allocable to [***]; or (iii) that are subject to [***], respectively, that would otherwise be [***], then Juno Co-Co Product Administration Liabilities incurred by Juno or Celgene in connection with [***] will not be included in the calculation of Operating Profit or Loss).

8.6 LIMITATION OF LIABILITY . EXCEPT (A) FOR A BREACH OF [***] OR (B) FOR CLAIMS THAT ARE SUBJECT TO INDEMNIFICATION UNDER THIS ARTICLE 8 OR (C) FOR DAMAGES DUE TO THE [***] OF THE LIABLE PARTY, NEITHER JUNO NOR CELGENE, NOR ANY OF THEIR RESPECTIVE AFFILIATES WILL BE LIABLE TO THE OTHER PARTY TO THIS JUNO LEAD CO-CO AGREEMENT OR ITS AFFILIATES FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE OR EXEMPLARY DAMAGES OR LOST PROFITS OR LOST DATA, WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY), INDEMNITY OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE.

ARTICLE 9

JUNO CO-CO TERM AND TERMINATION

9.1 Juno Co-Co Term; Expiration .

9.1.1 This Juno Lead Co-Co Agreement shall become effective on the Juno Lead Co-Co Agreement Effective Date and, unless earlier terminated pursuant to this Article 9, shall remain in effect until the Parties [***] Develop and Commercialize all Juno Program Co-Co Development Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products (the “ Juno Co-Co Term ”).

9.2 Termination Without Cause .

9.2.1 Termination by Celgene for Convenience . At any time during the Juno Co-Co Term, Celgene shall have the right, at its sole discretion, to terminate this Juno Lead Co-Co Agreement in its entirety, upon [***] prior written notice to Juno hereunder; it being understood and agreed that Celgene shall be entitled to terminate upon [***] written notice at any time it reasonably determines that such termination is necessary to comply with any Antitrust Law.

9.2.2 Termination by Celgene for [***] . Celgene shall have the right to terminate this Juno Lead Co-Co Agreement immediately on a Juno Program Co-Co Candidate-by-Juno Program Co-Co Candidate basis upon written notice to Juno based on [***]. Upon such termination for [***], subject to the terms and conditions of this Juno Lead Co-Co Agreement, Celgene shall be responsible, at its expense, for the wind-down, if any, of any Development of the applicable Juno Program Co-Co Candidate, and corresponding Juno Program Co-Co Product (including any Clinical Trials for the applicable Juno Program Co-Co Candidate or Juno Program Co-Co Product being conducted by or on behalf of Celgene) and any

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Commercialization Activities for the applicable Juno Program Co-Co Candidate or Juno Program Co-Co Product for which it is the Juno Co-Co Lead Party or for which it is performing other Development and/or Commercialization Activities. Such termination shall become effective upon the date that the Parties agree in writing that such wind-down is complete. Upon such termination for [***], all licenses granted by Juno to Celgene under this Juno Lead Co-Co Agreement shall terminate solely with respect to the applicable Juno Program Co-Co Candidate or Juno Program Co-Co Product. For purposes of this Juno Lead Co-Co Agreement, “[***]” means that [***], determines that Development of Juno Program Co-Co Candidates and/or Juno Program Co-Co Products should be discontinued because the medical risk/benefit of such Juno Program Co-Co Candidates or Juno Program Co-Co Products is sufficiently unfavorable as to be incompatible with the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize it. If this Juno Lead Co-Co Agreement is terminated pursuant to this Section 9.2.2, then subject to applicable data privacy laws, and on Juno’s request, Celgene shall provide Juno with [***], to the extent not previously provided to Juno, solely for the purposes of [***]. Upon Juno’s [***], Section 9.8 shall apply except for Section 9.8.2(c) and 9.8.2(h).

9.3 Termination for Breach .

9.3.1 Termination by Either Party for Breach .

(a) Subject to certain variations set forth in Section 10.3.2 with respect to a material breach by either Party of its obligation to use Commercially Reasonable Efforts pursuant to Section 2.2.2, this Juno Lead Co-Co Agreement and the rights granted herein may be terminated by either Party for the material breach by the other Party of this Juno Lead Co-Co Agreement, that, in the aggregate, frustrates the fundamental purpose of this Juno Lead Co-Co Agreement, provided, that the breaching Party has not cured such breach within [***] (or [***], in the case of the breaching Party’s payment obligations under this Juno Lead Co-Co Agreement, or the time period provided in Section 9.3.2 with respect to a material breach by a Party of its obligation to use Commercially Reasonable Efforts) (the “ Cure Period ”) after the date of written notice to the breaching Party of such breach, which notice shall describe such breach in reasonable detail and shall state the non-breaching Party’s intention to terminate this Juno Lead Co-Co Agreement pursuant to this Section 9.3.1. Notwithstanding the preceding sentence, the Cure Period for any allegation made in good faith as to a material breach under this Juno Lead Co-Co Agreement will run from [***]; and

(b) Any such termination of this Juno Lead Co-Co Agreement under this Section 9.3.1 shall become effective at the end of the Cure Period, unless the breaching Party has cured any such breach or default prior to the expiration of such Cure Period, or, if such breach is not susceptible to cure within the Cure Period, then, the non-breaching Party’s right of termination shall be [***]. The Parties understand and agree that [***] for purposes of determining [***].

9.3.2 Additional Procedures for Termination by a Party for Failure of the other Party to Use Commercially Reasonable Efforts . If either Party wishes to exercise its right to terminate this Juno Lead Co-Co Agreement pursuant to Section 9.3.1 for the other Party’s

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

45


material breach of its obligations to use Commercially Reasonable Efforts as set forth in Section 2.2.2, it shall provide to such other Party a written notice of its intent to exercise such right, which notice shall be labelled as a “notice of material breach for failure to use Commercially Reasonable Efforts,” and shall state the reasons and justification for such termination and [***]. For any such notice of breach given by a Party, the Cure Period shall be [***], and shall become effective in accordance with Section 9.3.1.

9.3.3 Disagreement as to Material Breach . If the Parties reasonably and in good faith disagree as to whether there has been a material breach pursuant to Section 9.3.1, the Party that disputes that there has been a material breach may contest the allegation by referring such matter, within [***] following such notice of alleged material breach for resolution to the Executive Officers, who shall meet promptly to discuss the matter, and determine, within [***] following referral of such matter, whether or not a material breach has occurred pursuant to Section 9.3.1. If the Executive Officers are unable to resolve a dispute within such [***] period after it is referred to them, the matter will be resolved as provided in Section 12.7 of the Master Collaboration Agreement.

9.4 Termination for Patent Challenges .

9.4.1 Termination by Celgene for Patent Challenge . Celgene shall have the right to terminate this Juno Lead Co-Co Agreement upon written notice if Juno or any of its Affiliates (as defined in Section 1.2(a) of the Master Collaboration Agreement) challenges the validity, scope or enforceability, or otherwise opposes any Patent included in the [***] that is licensed to Juno under this Juno Lead Co-Co Agreement (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order); it being understood and agreed that Celgene’s right to terminate this Juno Lead Co-Co Agreement under this Section 9.4 shall not apply to any Affiliate of Juno (as defined in Section 1.2(a) of the Master Collaboration Agreement) that first becomes such an Affiliate as a result of or after the effective date of a Business Combination involving Juno, where such new Affiliate was undertaking any of the activities described in the foregoing clause prior to such Business Combination; provided that Celgene’s right to terminate this Juno Lead Co-Co Agreement under this Section 9.4 shall apply to such new Affiliate if Juno is the acquiror in such Business Combination and such new Affiliate does not terminate or otherwise cease such challenge or opposition within [***] after the effective date of such Business Combination. If a Sublicensee of Juno challenges the validity, scope or enforceability of or otherwise opposes any Patent included in the [***] under which such Sublicensee is sublicensed, then Juno shall, [***] from Celgene, terminate such sublicense. For the avoidance of doubt, an action by Juno or any Affiliate (as defined in Section 1.2(a) of the Master Collaboration Agreement) in accordance with Article 7 of the Master Collaboration Agreement to amend claims within a pending patent application of Celgene during the course of Juno’s Prosecution and Maintenance of such pending patent application or in defense of a Third Party proceeding, or to make a negative determination of patentability of claims of a patent application of Celgene or to abandon a patent application of Celgene during the course of Juno’s Prosecution and Maintenance of such pending patent application, shall not constitute a challenge under this Section 9.4.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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9.4.2 Termination by Juno for Patent Challenge . Juno shall have the right to terminate this Juno Lead Co-Co Agreement upon written notice if Celgene or any of its Affiliates (as defined in Section 1.2(a) of the Master Collaboration Agreement) challenges the validity, scope or enforceability, or otherwise opposes any Patent included in the [***] that is licensed to Celgene under this Juno Lead Co-Co Agreement (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order); it being understood and agreed that Juno’s right to terminate this Juno Lead Co-Co Agreement under this Section 9.4 shall not apply to any Affiliate of Celgene (as defined in Section 1.2(a) of the Master Collaboration Agreement) that first becomes such an Affiliate as a result of or after the effective date of a Business Combination involving Celgene, where such new Affiliate was undertaking any of the activities described in the foregoing clause prior to such Business Combination; provided that Juno’s right to terminate this Juno Lead Co-Co Agreement under this Section 9.4 shall apply to such new Affiliate if Celgene is the acquiror in such Business Combination and such new Affiliate does not terminate or otherwise cease such challenge or opposition within [***] after the effective date of such Business Combination. If a Sublicensee of Celgene challenges the validity, scope or enforceability of or otherwise opposes any Patent included in the Juno Program Co-Co IP [***] under which such Sublicensee is sublicensed, then Celgene shall, [***], terminate such sublicense. For the avoidance of doubt, an action by Celgene or any of its Affiliates (as defined in Section 1.2(a) of the Master Collaboration Agreement) in accordance with Article 7 of the Master Collaboration Agreement to amend claims within a pending patent application of Juno during the course of Celgene’s Prosecution and Maintenance of such pending patent application or in defense of a Third Party proceeding, or to make a negative determination of patentability of claims of a patent application of Juno or to abandon a patent application of Juno during the course of Celgene’s Prosecution and Maintenance of such pending patent application, shall not constitute a challenge under this Section 9.4.

9.5 Termination for Bankruptcy . If either Party makes a general assignment for the benefit of creditors, appoints or suffers appointment of a receiver or trustee over all or substantially all of its property, files a petition under any bankruptcy or insolvency act or has any such petition filed against it which is not dismissed, discharged, bonded or stayed within ninety (90) days after the filing thereof, the other Party may terminate this Juno Lead Co-Co Agreement in its entirety, effective immediately upon written notice to such Party. In connection therewith, the provisions of Section 6.1.6 shall apply.

9.6 Termination for Breach of Standstill . Juno may terminate this Juno Lead Co-Co Agreement immediately upon written notice to Celgene, in the event that Juno exercises its right to terminate this Juno Lead Co-Co Agreement under Section 2.2 of the Voting and Standstill Agreement resulting in the termination of the Voting and Standstill Agreement (as defined in the Master Collaboration Agreement).

9.7 Effects of Expiration or Termination .

9.7.1 Termination by Celgene Pursuant to Section 9.2, or by Juno Pursuant to Section 9.3, 9.4, 9.5 or 9.6 . In the event this Juno Lead Co-Co Agreement is terminated by

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Celgene pursuant to Section 9.2 or by Juno pursuant to Section 9.3, 9.4, 9.5 or 9.6, then notwithstanding anything contained in this Juno Lead Co-Co Agreement to the contrary, upon the effective date of such termination:

(a) Juno Co-Co Termination . All licenses granted to Celgene under this Juno Lead Co-Co Agreement shall terminate in their entirety, Celgene shall cease any and all Development, and Commercialization Activities with respect to all terminated Juno Program Co-Co Candidates, Juno Program Co-Co Products and Juno Program Co-Co Diagnostic Products, and all rights in such terminated Juno Program Co-Co Candidates, Juno Program Co-Co Product and Juno Program Co-Co Diagnostic Products granted by Juno to Celgene shall revert to Juno pursuant to Section 9.8;

(b) Return of Confidential Information . Each Party shall return or destroy all Confidential Information of the other Party pursuant to Article 8 of the Master Collaboration Agreement, unless such information is practiced by the receiving Party pursuant to licenses retained after any such termination under this Juno Lead Co-Co Agreement, another Development & Commercialization Agreement or the Master Collaboration Agreement; and

(c) Survival of License . The license granted to Juno in Section 6.1.2 shall automatically convert to the applicable license set forth in Section 9.8.

(d) Ongoing Activities . If [***] had exercised its right to participate in Commercialization Activities in the [***] Territory pursuant to Section 3.1.2, and if [***] the termination of this Juno Lead Co-Co Agreement becomes effective, [***] will have the right [***]. [***] shall exercise the foregoing right by providing written notice to [***] thereof prior to the date that is [***] after the effective date of such termination, stating that [***]. Celgene shall [***].

9.7.2 Termination by Celgene Pursuant to Sections 9.3, 9.4 or 9.5 . In the event this Juno Lead Co-Co Agreement is terminated by Celgene pursuant to Sections 9.3, 9.4 or 9.5, then (a) subject to Section 9.10, all rights and obligations of the Parties under this Juno Lead Co-Co Agreement shall terminate, except that Section 9.8 shall apply following the effective date of such termination, and (b) each Party shall return or destroy any Confidential Information of the other Party pursuant to Article 8 of the Master Collaboration Agreement that is not necessary to practice any licenses and other rights retained by such Party following such termination under this Juno Lead Co-Co Agreement, another Development & Commercialization Agreement or the Master Collaboration Agreement.

9.8 Juno Program Co-Co Reversion Products .

9.8.1 Reversion . If this Juno Lead Co-Co Agreement terminates for any reason, then all Juno Program Co-Co Candidates, Juno Program Co-Co Products and/or Juno Program Co-Co Diagnostic Products shall be deemed “ Juno Program Co-Co Reversion Products ”. Subject to the remainder of this Section 9.8.1, Celgene shall grant and hereby grants to Juno a non-exclusive, royalty-free, non-assignable (except as provided in Section 10.4) license, with the right to grant sublicenses [***], under [***] (a) [***], (b) [***], and (c) [***], in each case of (a) through (c), [***] Research, Develop, Manufacture, use, import, offer for sale, sell, and Commercialize Juno Program Co-Co Reversion Products in the Territory in the Field, and (d) [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

48


9.8.2 Effects of Reversion . With respect to each Juno Program Co-Co Candidate, Juno Program Co-Co Product and Juno Program Co-Co Diagnostic Product that becomes a Juno Program Co-Co Reversion Product:

(a) Celgene shall return to Juno [***], at no cost to Juno, all Know-How within the Juno Program Co-Co IP transferred by Juno to Celgene with respect to each such Juno Program Co-Co Reversion Product;

(b) Except to the extent not permitted pursuant to any agreements between Celgene and a Third Party, Celgene shall provide to Juno, [***], at Juno’s request, subject to Juno’s [***] pertaining to the applicable Juno Program Co-Co Reversion Products [***] such Juno Program Co-Co Reversion Products, including copies of (i) [***] Juno Program Co-Co Reversion Products, and (ii) materials and documents relating to [***] Juno Program Co-Co Reversion Products throughout the ROW Territory and/or the North America Territory (if applicable). For clarity, Juno shall have the right to use the foregoing [***] information, materials and data [***] of Juno Program Co-Co Reversion Products;

(c) Celgene shall provide [***] with Juno Program Co-Co Reversion Products in the ROW Territory prior to reversion of such Juno Program Co-Co Reversion Products to Juno, at Juno’s request [***];

(d) Celgene shall transfer within a reasonable time to Juno, at Juno’s request and at Juno’s expense, any and all Regulatory Filings pertaining to the applicable Juno Program Co-Co Reversion Products in the ROW Territory in its possession or Control;

(e) with respect to any Juno Program Co-Co Candidate or Juno Program Co-Co Product that becomes an Juno Program Co-Co Reversion Product as a result of termination of this Juno Lead Co-Co Agreement at a time during which Celgene is conducting a Clinical Trial for such Juno Program Co-Co Candidate or Juno Program Co-Co Product, Celgene will, as directed by Juno, [***], if such termination is pursuant to Sections 9.3, 9.4, 9.5 or 9.6 (in each case by Juno), and otherwise [***];

(f) Celgene shall otherwise cooperate reasonably with Juno to provide a transfer of the materials described in Sections 9.8.2(a) through (e), such transfer to be completed within [***] after the Parties have identified the Know-How and Regulatory Filings to be transferred;

(g) As and to the extent a Third Party is manufacturing such Juno Program Co-Co Reversion Product for Celgene, or for supply to Juno by Celgene, Celgene shall [***], to assist in [***]. If, at any time during the Juno Co-Co Term, Celgene or an Affiliate of Celgene begins manufacturing any Juno Program Co-Co Candidate or Juno Program Co-Co Product, the Parties shall [***] of such Juno Program Co-Co Candidate or Juno Program Co-Co Product from Celgene or such Affiliate to Juno or Juno’s designee in the event such Juno

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

49


Program Co-Co Candidate or Juno Program Co-Co Product becomes a Juno Program Co-Co Reversion Product, which shall include [***]. Additionally, upon any Juno Program Co-Co Candidate or Juno Program Co-Co Product becoming a Juno Program Co-Co Reversion Product, at Juno’s request, Celgene shall [***], for a price equal to [***];

(h) To the extent that Celgene owns any trademark(s) and/or domain names that [***] a Juno Program Co-Co Reversion Product that [***] for the Commercialization of a Juno Program Co-Co Reversion Product (as [***], but not including any marks that include, in whole or part, any corporate name or logo of Celgene), Juno shall have the right to [***]. Juno shall exercise such right by written notice to Celgene within [***] after such Juno Program Co-Co Candidate, Juno Program Co-Co Product or Juno Program Co-Co Diagnostic Product becomes a Juno Program Co-Co Reversion Product. The Parties shall [***] to Juno for up to [***] after Celgene receives any such written notice from Juno; and

(i) If Celgene has obtained a Third Party License with respect to such Juno Program Co-Co Reversion Product and Juno is a sublicensee under such Third Party License, then [***] such Third Party License to the extent due with respect to the [***].

9.9 Survival of Sublicensees . Juno’s right to grant sublicenses under the licenses granted in Section 9.8 shall survive any termination of this Juno Lead Co-Co Agreement. With the exception of the foregoing, termination of this Juno Lead Co-Co Agreement shall be construed as a termination of any sublicense granted by either Party to any Sublicensee hereunder, provided however that such Sublicensee shall have the right to request that such Party grants to such Sublicensee a direct license, and such Party [***].

9.10 Surviving Provisions .

9.10.1 Accrued Rights; Remedies . Termination, relinquishment or expiration of this Juno Lead Co-Co Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of any Party prior to such termination, relinquishment or expiration, including the payment obligations under Article 5 hereof, and any and all damages or remedies (whether in law or in equity) arising from any breach hereunder. Such termination, relinquishment or expiration shall not relieve any Party from obligations which are expressly indicated to survive termination of this Juno Lead Co-Co Agreement. Except as otherwise expressly set forth in this Juno Lead Co-Co Agreement, the termination provisions of this Article 9 are in addition to any other relief and remedies available to either Party under this Juno Lead Co-Co Agreement and at applicable Law.

9.10.2 Survival . Notwithstanding any provision herein to the contrary, any rights or obligations otherwise accrued hereunder (including any accrued payment obligations) shall survive the expiration or termination of this Juno Lead Co-Co Agreement. Further, the rights and obligations of the Parties set forth in the following Sections, Articles and Exhibits shall survive the expiration or termination of this Juno Lead Co-Co Agreement, in addition to those other terms and conditions that are expressly stated to survive termination or expiration of this Juno Lead Co-Co Agreement: Sections (a) 2.3.3(b), 2.3.7(b), 2.5 (as to activities conducted during the Juno Co-Co Term and activities conducted thereafter to the extent applicable to Juno’s

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

50


retained rights and licenses pursuant to Section 9.8), 2.6.1 (as to Juno Program Co-Co Materials transferred during the Juno Co-Co Term), 2.6.2 (to the extent that the Juno Co-Co Materials Receiving Party retains a license to use such Juno Co-Co Materials following termination), 2.6.3 (as to Juno Co-Co Materials transferred during the Juno Co-Co Term), 2.7, 5.4.3 (as to activities conducted during the Juno Co-Co Term), 6.1.3 (to the extent applicable), 6.1.4, 6.1.5, 6.1.6, 6.2, 6.5 (to the extent Juno retains rights and licenses [***], and except that Section 6.5.10 shall apply only if [***], 6.7, 6.8, 6.9 (last sentence, to the extent [***] license after termination), Article 7 (to the extent applicable to claims arising [***] exercise of its rights and licenses [***]), Article 8 (to the extent applicable to claims arising [***] of provisions that are deemed to survive pursuant to this Juno Lead Co-Co Agreement or to the extent a Party [***] from the other Party to Develop, Manufacture or Commercialize Juno Program Co-Co Candidates, Juno Program Co-Co Products or Juno Program Co-Co Diagnostic Products after such termination), Sections 9.7, 9.8, 9.9, 9.10, 9.11, Article 10 and Exhibit A , Exhibit B , Exhibit D (to the extent applicable to activities conducted [***]) and Exhibit H (to the extent applicable to activities conducted [***]); provided that such survival shall be limited to any specific time periods set forth in such Articles and Sections.

9.11 Relationship to Other Agreements . Termination of this Juno Lead Co-Co Agreement shall not affect in any way the terms or provisions of the Master Collaboration Agreement, any other then-existing executed Development & Commercialization Agreement or the Equity Purchase Agreement.

ARTICLE 10

MISCELLANEOUS

10.1 Confidentiality; Publicity .

10.1.1 Confidentiality . The confidentiality, non-disclosure and non-use obligations set forth in Article 8 of the Master Collaboration Agreement, including each Party’s rights and obligations with respect to publicity and publications set forth in Sections 8.6 and 8.7 of the Master Collaboration Agreement, shall apply to the Parties’ performance of all activities under this Juno Lead Co-Co Agreement.

10.1.2 Press Release . Upon or following the Juno Lead Co-Co Agreement Effective Date, the Parties may issue the form of press release agreed by the Parties pursuant to Section 8.6 of the Master Collaboration Agreement and attached hereto as Exhibit G . In all other cases, the issuance of any press release or other public statement by either Party or their respective Affiliates disclosing any information relating to this Juno Lead Co-Co Agreement, the activities hereunder, or the transactions contemplated hereby shall be subject to Section 8.6 of the Master Collaboration Agreement.

10.2 Disclaimer of Warranties . Except as otherwise expressly set forth in this Juno Lead Co-Co Agreement or the Master Collaboration Agreement, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY THAT ANY PATENTS ARE VALID OR ENFORCEABLE, AND EXPRESSLY DISCLAIMS ALL IMPLIED

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

51


WARRANTIES, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. Without limiting the generality of the foregoing, each Party disclaims any warranties with regards to: (a) the success of any study or test, including the Juno Co-Co Program, commenced under this Juno Lead Co-Co Agreement; (b) the safety or usefulness for any purpose of the technology or materials, including any Juno Program Co-Co Candidate, Juno Program Co-Co Product or Juno Program Co-Co Diagnostic Product, it provides or discovers under this Juno Lead Co-Co Agreement; or (c) the validity, enforceability, or non-infringement of any intellectual property rights or technology it provides or licenses to the other Party under this Juno Lead Co-Co Agreement.

10.3 Applicability of Terms of Master Collaboration Agreement . In addition to those provisions of the Master Collaboration Agreement that are expressly stated in this Juno Lead Co-Co Agreement to apply to the Parties activities hereunder, Sections 12.1, 12.2, 12.3, 12.5, 12.6, 12.7, 12.8, 12.9 (with respect to the Parties ability to bind one another and with respect to third party beneficiaries), 12.11, 12.12, 12.13, 12.14 and 12.15 of the Master Collaboration Agreement shall apply in full to the Party’s performance of all activities under this Juno Lead Co-Co Agreement. References to “Agreement” in such sections shall refer to this Juno Lead Co-Co Agreement.

10.4 Assignment .

10.4.1 Generally . This Juno Lead Co-Co Agreement may not be assigned by any Party, nor may any Party delegate its obligations or otherwise transfer licenses or other rights created by this Juno Lead Co-Co Agreement, except as expressly permitted hereunder without the prior written consent of the other Party, which consent will not be unreasonably withheld, delayed or conditioned.

10.4.2 Celgene . Notwithstanding the limitations in Section 10.4.1, Celgene Corp. and Celgene RIVOT may assign this Juno Lead Co-Co Agreement, or any rights or obligations hereunder in whole or in part, to (a) one or more Affiliates solely as provided in this Section 10.4.2 or (b) its successor in interest in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Juno Lead Co-Co Agreement; provided however that, except in the case where Celgene Corp., or Celgene RIVOT, as applicable, [***], (i) Celgene Corp. or Celgene RIVOT, as applicable, provides Juno with at least [***] advance written notice of any such assignment(s), (ii) prior to such assignment(s), Celgene Corp. or Celgene RIVOT, as applicable, agrees in a written agreement delivered to Juno (and upon which Juno may rely) to remain fully liable for the performance of its obligations under this Juno Lead Co-Co Agreement by its assignee(s), and (iii) prior to such assignment(s), the assignee(s) agree in a written agreement delivered to Juno (and upon which Juno may rely) to assume performance of all such assigned obligations. If Celgene Corp. or Celgene RIVOT, as applicable, wishes to assign [***], it will be permitted to do so conditioned on such [***].

10.4.3 Juno . Notwithstanding the limitations in Section 10.4.1, Juno may assign

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

52


this Juno Lead Co-Co Agreement, or any rights or obligations hereunder in whole or in part, to (a) one or more Affiliates solely as provided in this Section 10.4.3 or (b) its successor in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Juno Lead Co-Co Agreement; provided however that, except in the case where Juno [***], (i) Juno provides Celgene with at least [***] advance written notice of any such assignment(s), (ii) prior to such assignment(s), Juno agrees in a written agreement delivered to Celgene (and upon which Celgene may rely) to remain fully liable for the performance of its obligations under this Juno Lead Co-Co Agreement by its assignee(s), and (iii) prior to such assignment(s), the assignee(s) agree in a written agreement delivered to Celgene (and upon which Celgene may rely) to assume performance of all such assigned obligations, (iv) in the case of any assignment(s) by Juno, all [***], and (v) all of the matters referred to in clauses (i), (ii), (iii) and (iv), as applicable, will be set forth in documentation [***] prior to any such assignment(s) [***] and in all cases will provide [***]. If Juno wishes to assign [***], it will be permitted to do so conditioned on [***].

10.4.4 All Other Assignments Null and Void . The terms of this Juno Lead Co-Co Agreement will be binding upon and will inure to the benefit of the successors, heirs, administrators and permitted assigns of the Parties. Any purported assignment in violation of this Section 10.4 will be null and void ab initio.

10.4.5 Business Combinations . Notwithstanding anything to the contrary in this Juno Lead Co-Co Agreement, with respect to any intellectual property rights controlled by the acquiring party or its Affiliates (if other than one of the Parties to this Juno Lead Co-Co Agreement) involved in any Business Combination of either Party, such intellectual property rights shall not be included in the technology and intellectual property rights licensed to the other Party hereunder to the extent held by such acquirer or its Affiliate (other than the relevant Party to this Juno Lead Co-Co Agreement) prior to such transaction, or to the extent such technology is developed outside the scope of activities conducted with respect to the Collaboration, Juno Co-Co Program, Juno Program Co-Co Candidates, Juno Program Co-Co Products or related Juno Program Co-Co Diagnostic Products. The Juno Program Co-Co IP and the [***] shall exclude any intellectual property [***] by a permitted assignee or successor and not developed in connection with the Collaboration, Juno Co-Co Program, Juno Program Co-Co Candidates, or Juno Program Co-Co Products, or related Juno Program Co-Co Diagnostic Products, researched, Developed or Commercialized pursuant to this Juno Lead Co-Co Agreement, any other Development & Commercialization Agreement or the Master Collaboration Agreement.

10.5 Entire Agreement . This Juno Lead Co-Co Agreement, together with the attached Exhibits and Schedules, and the Master Collaboration Agreement, including its Exhibits and Schedules, contains the entire agreement by the Parties with respect to the subject matter hereof and supersedes any prior express or implied agreements, understandings and representations, either oral or written, which may have related to the subject matter hereof in any way, and any and all term sheets relating to the transactions contemplated by this Juno Lead Co-Co Agreement and exchanged between the Parties prior to the Juno Lead Co-Co Agreement Effective Date.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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[Signature Page Follows]

 

54


IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have caused this JUNO LEAD CO-CO AGREEMENT to be executed by their respective duly authorized officers as of the Juno Lead Co-Co Agreement Effective Date.

 

JUNO THERAPEUTICS, INC.       CELGENE CORPORATION

By:

 

 

      By:  

 

Name:  

 

      Name:  

 

Title:  

 

      Title:  

 

        CELGENE RIVOT LTD.
        By:  

 

        Name:  

 

        Title:  

 

[Signature page to Juno Lead Co-Co Agreement]

 


EXHIBIT A

Juno Co-Co Program

The Juno Co-Co Program that is the subject of this Juno Lead Co-Co Agreement is:

¨ the [              ] Program,

which is a

¨ a Celgene Co-Promote Program;

¨ an Eligible BD Program;

¨ an [***] BD Program;

¨ an [***] Program; or

¨ a [***] BD Program for which [***] was the BD Acquiring Party.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

A - 1


EXHIBIT B

Juno Program Co-Co Target, Juno Program Co-Co Candidates and [***]

For the Juno Co-Co Program that is:

¨ the [              ] Program, then:

 

  A. the “ Juno Program Co-Co Target ” is: [              ];

 

  B. the “ Juno Program Co-Co Candidates ” are: (i) each [***] Agent that is within the [***] for the Juno Program Co-Co Target and is [***], and that is [***] either Party or any of its Affiliates prior to or after the Juno Lead Co-Co Agreement Effective Date [***]. For clarity, and as set forth in Section 1.109 of the Master Collaboration Agreement, Juno Program Co-Co Candidates also include [***]; and

 

  C. the [***] are: [***]

¨ For clarity, for each of the foregoing Juno Co-Co Programs, in no event shall any Target of an Excluded Program be a Juno Program Co-Co Target.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

B - 1


EXHIBIT C

Co-Co Upfront Payments

In consideration for the rights and licenses granted to Celgene (or to Juno with respect to any [***] BD Program for which [***] is the BD Acquiring Party) under this Juno Lead Co-Co Agreement with respect to the Juno Co-Co Program:

1. Option Exercise and Designation Payments .

(a) If the Parties have entered into this Juno Lead Co-Co Agreement as a result of Celgene’s delivery of a BD Option Exercise Notice for an Eligible BD Program [***], Celgene shall, within [***] after delivery to Juno of the BD Option Exercise Notice for such Eligible BD Program, pay to Juno [***]. Additionally, if [***].

(b) If the Parties have (i) entered into this Juno Lead Co-Co Agreement as a result of Celgene’s exercise of the Celgene Co-Promote Right for a Juno Program or an [***] Program at the same time as Celgene delivered a Celgene Option Exercise Notice or an [***] Exercise Notice, for such Juno Program or an [***] Program, each as applicable, (ii) the Parties [***], and (iii) Celgene has elected to [***], then Celgene shall, within [***] following the delivery of such Celgene Option Exercise Notice, pay to Juno [***], as applicable

(c) If the Parties have entered into this Juno Lead Co-Co Agreement as a result of Celgene’s exercise of the Celgene Co-Promote Right [***], then [***].

(d) If the Parties have (i) entered into this Juno Lead Co-Co Agreement as a result of Celgene’s exercise of the Celgene Co-Promote Right [***], (ii) the Parties [***], and (iii) Celgene has elected [***].

(e) If the Parties have entered into this Juno Lead Co-Co Agreement with respect to an [***] BD Program for which Celgene has delivered an [***] Option Exercise Notice pursuant to Section 3.1.5 of the Master Collaboration Agreement, Celgene shall, within [***] after delivery to Juno of the [***] Option Exercise Notice for such [***] BD Program, pay to Juno the [***] Opt-In Payment [***]. Additionally, if [***].

(f) If the Parties have entered into this Juno Lead Co-Co Agreement as a result of Juno’s delivery of a BD Option Exercise Notice for [***] BD Program for which [***], Juno shall, within [***] after delivery to Celgene of the BD Option Exercise Notice for such [***] BD Program, pay to [***]. Additionally, if [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

C - 1


EXHIBIT D

Profit & Loss Share

This Exhibit D to this Juno Lead Co-Co Agreement covers financial planning, accounting policies and procedures to be followed in determining the Profit & Loss Share. The Profit & Loss Share is not a legal entity and has been defined for identification purposes only.

1. Principles of Reporting .

(a) The presentation of results of operation of the Parties with respect to Juno Program Co-Co Products in the Territory will be based on each Party’s respective financial information presented separately and on a consolidated basis in the reporting format depicted as follows with respect to all countries within Territory, for calculating Profit & Loss Share for Juno Program Co-Co Products for Celgene Territory Administration and Juno Territory Administration:

 

     Juno    Celgene

Total

         

[***]

     

[***]

     

[***]

     

[***]

     

[***]

     

[***]

     

(b) It is the intention of the Parties to interpret definitions to be consistent with this Exhibit D and Accounting Principles, it being understood and agreed that (i) “Operating Profits or Losses” shall be calculated in accordance with [***], and (ii) [***]. For clarity, Juno is the Lead Party with respect to Development and Commercialization of Co-Co Products for Juno Territory Administration and Celgene is the Lead Party with respect to Development and Commercialization of Co-Co Products for Celgene Territory Administration. Where such costs will be determined based on [***], each Party agrees to provide reasonable supporting documentation, as may be requested by the other Party, to ensure that each Party’s methodologies are reasonable and consistently applied. To the extent that such costs are not readily determinable [***], the JCC will develop a reasonable methodology for determining such costs. Reasonable methodologies may include a standard rate or some other appropriate basis for allocating costs.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

D - 1


(c) If necessary, a Party will make the appropriate adjustments to the financial information it supplies under this Exhibit D to conform to the above format of reporting results of operation.

(d) The Parties agree that all Juno Co-Co Net Sales of Juno Program Co-Co Product for Juno Territory Administration will be booked by Juno, and that all Juno Co-Co Net Sales of Juno Program Co-Co Product for Celgene Territory Administration will be booked by Celgene.

2. Frequency of Reporting .

(a) The fiscal year for the purposes of reporting and other activities undertaken by the Parties pursuant to this Exhibit D will be a Calendar Year. Unless the schedule of such reporting is altered by the JSC, reporting by each Party for revenues and expenses will be as set forth in this Paragraph 2 of this Exhibit D .

(b) The Lead Party will prepare, for sales of Juno Program Co-Co Product booked by such Lead Party, a consolidated reporting of the activities undertaken by the Parties hereunder (including Operating Profit or Loss), the calculation of the Operating Profit or Loss sharing, and determination of the cash settlement as between the Parties. The Lead Party will provide the non-Lead Party within [***] after the end of each Calendar Quarter, a detailed statement showing the consolidated results and calculations of the Operating Profit or Loss sharing and cash settlement required in a format agreed to by the Parties (the “ Report ”). The non-Lead Party will cooperate as appropriate and provide the Lead Party booking sales of Juno Program Co-Co Product with financial statements, within [***] of the end of each Calendar Quarter, for the non-Lead Party’s activities with respect to Juno Program Co-Co Product, prepared in accordance with the terms contained in the financial planning, accounting and reporting procedures set forth in this Exhibit D in order for the Lead Party to prepare the consolidated reports, including in reasonable detail the following costs and expenses incurred by the non-Lead Party in such Calendar Quarter: [***].

(c) On a [***] basis, the Lead Party will supply the other with an estimate of Juno Co-Co Net Sales during the prior month of such Juno Program Co-Co Product for Juno Territory Administration (in the case of Juno), and for Celgene Territory Administration (in the case of Celgene), [***] (using the conversion method set forth in this Juno Lead Co-Co Agreement) according to such Party’s sales reporting system, which will be [***]. The Lead Party shall also provide to the other Party information regarding [***]. Each such report will be provided [***] after the last day of the [***] in question, and will separately provide monthly and year-to-date cumulative figures. The Lead Party will provide to the other Party, [***], an updated report for the [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

D - 2


3. Financial Records . With respect to all financial records and reports required by this Exhibit D , each Party to the extent applicable hereunder will keep financial records in accordance with its Accounting Principles. All cost reporting will be based on the appropriate costs definitions stated in Paragraph 7 of this Exhibit D or elsewhere in this Juno Lead Co-Co Agreement, and each Party will report costs in a manner consistent with a mutually agreed standard.

4. Operating Profits and Loss Sharing .

(a) The Parties agree to share equally (which, for clarity, shall mean that Juno shall bear (and be entitled to) [***], and Celgene will bear (and be entitled to) [***] of the Operating Profit or Loss with respect to Juno Program Co-Co Product as set forth in Section 5.2 of this Juno Lead Co-Co Agreement.

(b) The Lead Party shall either invoice the non-Lead Party, or pay to the non-Lead Party, at the time the Report is delivered to Juno, an amount such that Juno will be bearing its Profit & Loss Share (as defined in Section 5.2 of this Juno Lead Co-Co Agreement) for the relevant sales of Juno Program Co-Co Product. The non-Lead Party shall make payment in full to the Lead Party of the amount of any such invoice, within [***] after the date of such invoice, if applicable, and the Lead Party shall pay the non-Lead Party within [***] after the Report is delivered to the non-Lead Party, if applicable, an amount such that the non-Lead Party will bear or receive its Profit & Loss Share. Such amounts will be invoiced and paid (whether before or after Regulatory Approval is received) pursuant to this Paragraph 4(b) of this Exhibit D . All payments to be made by either Party hereunder will be made in U.S. Dollars by wire transfer to such bank account as such Party may designate.

(c) In the event any payment is made after the date specified in Paragraph 4(b) of this Exhibit D and provided that such payment is not otherwise subject to good faith dispute, the paying Party will pay the additional amounts or the receiving Party will reimburse such excess payments, with interest from the date originally due as provided in Section 6.4.2 of this Juno Lead Co-Co Agreement.

5. Start of Operations and Effective Accounting Date Termination .

(a) Operation of the Profit & Loss Share will be [***]. Except as otherwise provided herein, costs and expenses incurred prior to such date are [***].

(b) Unless otherwise set forth in this Juno Lead Co-Co Agreement, for reporting and accounting purposes with respect to the Profit & Loss Share, the effective termination date of the Juno Lead Co-Co Agreement with regard to the last detailing year for Juno Program Co-Co Product will be the end of the month in which such termination takes place.

6. Audits . Each Party will keep, and will cause its Affiliates and Sublicensees, as applicable, to keep, accurate books and records of accounting as required under its Accounting Principles for the purpose of calculating all amounts payable by either Party to the other Party under the Profit

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

D -3


& Loss Share, including with respect to the calculation of Allowable Expenses, Gross Profit and Juno Co-Co Net Sales of Juno Program Co-Co Product for Juno Territory Administration (in the case of Juno and its Affiliates and Sublicensees) and Celgene Territory Administration (in the case of Celgene, its Affiliates and Sublicensees). Such records shall be retained by each Party or any of its Affiliates or Sublicensees (in such capacity, the “ Recording Party ”) for a period of no less than [***] after the [***] to which such records relate. At the request of either Party, the other Party will, and, will cause its Affiliates and Sublicensees, as applicable, to, permit the requesting Party and its representatives (including an independent auditor), at reasonable times and upon reasonable notice to the Recording Party, to inspect, review and audit the books and records maintained pursuant to this Paragraph 6 of this Exhibit D . Such examinations may not, unless otherwise required by applicable Law, (a) be conducted for any [***] more than [***] after the end of [***], (b) be conducted more than [***] in any [***] period, or (c) [***]. Except as provided below, the cost of this examination will be borne by the Party that requested the examination, unless the audit reveals a variance of more than [***] from the reported amounts, in which case the audited Party will bear the cost of the audit. Unless disputed as described below, if such audit concludes that additional payments were owed or that excess payments were made during such period, the paying Party will pay the additional amounts or the receiving Party will reimburse such excess payments, with interest from the date originally due as provided in Section 6.4.2 of this Juno Lead Co-Co Agreement, within [***] after the date on which a written report of such audit is delivered to the Parties. In the event of a dispute regarding such books and records, including the amounts owed to a Party under Section 5.2 of this Juno Lead Co-Co Agreement or the calculation of Allowable Expenses, Juno Co-Co Net Sales of Juno Program Co-Co Product or Gross Profit, the Parties will work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute [***], such dispute will be resolved in accordance with Section 12.7 of the Master Collaboration Agreement. The receiving Party will treat all information subject to review under this Paragraph 6 of this Exhibit D in accordance with the confidentiality provisions of Article 8 of the Master Collaboration Agreement and the Parties will cause any auditor or arbitrator to enter into a reasonably acceptable confidentiality agreement with the audited Party obligating such firm to retain all such financial information in confidence pursuant to a confidentiality agreement.

7. Definitions .

(a) “ Allocable Overhead ” means the following costs, attributable to the Profit & Loss Share, all of which will be consistent with Accounting Principles in accordance with each Party’s then-current practices and reported in a manner consistent with a standard mutually agreed upon by the Parties:

(i) [***]; and

(ii) [***].

(b) “ Allowable Expenses ” means the sum of the following costs and expenses incurred during the term the Profit & Loss Share is applicable, as set forth in Paragraph 5 of this

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

D - 4


Exhibit D , which will coincide with the Juno Co-Co Term, by the Parties, their Affiliates or Sublicensees, pursuant to the Commercialization, including Manufacturing, of Juno Program Co-Co Products in accordance with this Juno Lead Co-Co Agreement, during the applicable Calendar Quarter or the applicable Calendar Year: [***], in each case that are incurred in accordance with the Co-Co Commercialization Budget, the Juno Co-Co Development Budget and the terms and conditions of this Juno Lead Co-Co Agreement.

(c) “ Juno Co-Co Development Costs ” means on a Juno Program Co-Co Product-by-Juno Program Co-Co Product basis, the costs actually incurred by the Parties, their Affiliates or Sublicensees, in accordance with the Juno Co-Co Development Budget with respect to those Development activities performed pursuant to the Juno Co-Co Development Plan, from and after the Juno Lead Co-Co Agreement Effective Date. In determining “Juno Co-Co Development Costs” chargeable under this Juno Lead Co-Co Agreement will be calculated using [***].

(d) “ Costs of Goods Sold ” or “ COGS ” means the sum of (i) [***], (ii) [***], (iii) [***], and (iv) [***].

(e) “ Distribution Costs ” means the costs, including [***] to the distribution of a Juno Program Co-Co Product for Celgene Territory Administration (in the case of Celgene), or for Juno Territory Administration (in the case of Juno), in each case for end use by a Party and reported in a manner mutually agreed upon by the Parties, including [***] to the extent not reimbursed by a Third Party.

(f) “ Gross Profit ” means Juno Co-Co Net Sales of Juno Program Co-Co Product less Cost of Goods Sold for sales of such Juno Program Co-Co Product.

(g) “ Manufacturing Costs ” means costs to supply [***] (i) supplied by [***], or (ii) manufactured directly by either Party or its Affiliates or Sublicensees; it being understood and agreed that (A) in the case of costs referred to in subsection (i) of this sentence where [***] is the manufacturer, Manufacturing Costs will equal [***] of the amounts invoiced by (1) [***] and (2) [***] engaged by such Party or its Affiliates to provide [***], and (ii) in the case of costs referred to in subsection (ii) of this sentence where either Party or one of its Affiliates or its Sublicensees is the manufacturer, Manufacturing Costs will equal the [***], which manufacturing costs: (x) will include [***] allocable to the applicable Juno Program Co-Co Product, and (y) will be calculated in accordance with its Accounting Principles and the manufacturing party’s [***], and (z) notwithstanding anything to the contrary, will exclude [***]. Overhead included in Manufacturing Costs incurred with respect to activities conducted at the same facility for (i) [***], will each be allocated on a reasonable basis that is mutually agreed upon by the Parties.

(h) “ Marketing Costs ” means [***] costs incurred by the Parties, their Affiliates or Sublicensees, arising from activities [***] of Juno Program Co-Co Product (i.e., [***] related to the Juno Program Co-Co Product and approved by the JSC, in each case that are incurred in accordance with the Juno Co-Co Commercialization Budget. Such costs will include [***]. Marketing Costs will also include [***]. Marketing Costs will specifically exclude the costs of [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

D - 5


(i) “ Operating Profits or Losses ” means Gross Profit for Juno Program Co-Co Product less the Allowable Expenses. The Parties agree that Operating Profit or Loss will not include costs or expenses of a Party or its Affiliates or Sublicensees that are: (i) [***], or (ii) subject to [***] (and for clarity, if [***] will not be included in the calculation of Operating Profit or Loss).

(j) “ Other Operating Income/Expense ” means the following items, to the extent incurred with respect to and reasonably related to the Commercialization of Juno Program Co-Co Product with respect to the relevant country(ies) under this Juno Lead Co-Co Agreement:

(i) [***];

(ii) [***];

(iii) [***];

(iv) [***];

(v) [***]; and

(vi) [***]

(k) “ Pharmacovigilance Expenses ” means those expenses incurred [***].

(l) “ Product Recall Expenses ” means [***], except to the extent already allocated pursuant to subsection (h).

(m) “ Regulatory Expenses ” means all costs incurred, with respect to Juno Program Co-Co Product in the relevant country(ies) to [***] during the Juno Co-Co Term and pursuant to this Juno Lead Co-Co Agreement, that are specifically identifiable or reasonably allocable to [***], including without limitation compliance with requirements of such Regulatory Authorities, adverse event recordation and reporting, regulatory affairs activities, and all Product Recall Expenses.

(n) “ Sales Costs ” means costs, arising from activities expressly set forth in the Juno Co-Co Commercialization Plan or otherwise approved by the JSC or JCC which are [***]. Subject to the foregoing, “Sales Costs” will include [***], consisting of [***], all to the extent such costs are set forth in the Juno Co-Co Commercialization Budget or otherwise approved by the JSC or JCC. “Sales Costs” will include [***]. A mutually agreeable methodology for determining such costs which [***] will be set forth in the Juno Co-Co Commercialization Budget.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

D - 6


(o) “ Sublicense Revenues ” means [***] received by either Party or its Affiliates from a Sublicensee as consideration for the grant of a sublicense under the licenses granted with respect to Juno Program Co-Co Product.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

D - 7


EXHIBIT E

Form of Juno Co-Co Material Transfer Agreement

This Juno Co-Co Material Transfer Agreement No.     (the “ Juno Co-Co Material Transfer Agreement ”) is made as of                      (the “ Juno Co-Co Material Transfer Agreement Effective Date ”), pursuant to that certain Juno Lead Co-Co Agreement for the [ List Program ] Program, entered into by Juno Therapeutics, Inc., Celgene Corporation and Celgene Alpine Investment Company II, LLC, with an effective date of [●], 20     (the “[ List Program ] Program Juno Lead Co-Co Agreement ”), by and between:

Transferring Party: [ Please identify transferring party ]

And

Juno Co-Co Material Receiving Party: [ Please identify receiving party ]

for the transfer of:

 

A. Confidential Information :

[Please identify any Confidential Information other than Juno Co-Co Materials that would be transferred, e.g., assay protocols. If none, state “None.”]

 

B. Co-Co Materials :

[Please identify all Co-Co Materials to be transferred by type and name, as well as specifying the amount transferred. If none, state “None.”]

for the following Program(s):

 

  ¨ [              ] Program

 

  ¨     

and for the purpose of:

[Please describe purpose and scope of use of such Confidential Information and/or Co-Co Materials]

The Parties acknowledge and agree that the transfer of Confidential Information and/or Juno Co-Co Materials pursuant to this Juno Co-Co Material Transfer Agreement will be pursuant to and in accordance with the terms and conditions of the Master Collaboration Agreement and this [ list Program ] Juno Lead Co-Co Agreement. Any capitalized terms used in this Juno Co-Co Material Transfer Agreement that are not defined herein have the meanings ascribed to them in the Master Collaboration Agreement or the [ list Program ] Juno Lead Co-Co Agreement, as applicable.

 

E - 1


[ Signature Page Follows ]

 

E - 2


IN WITNESS WHEREOF, this Juno Co-Co Material Transfer Agreement is entered into as of the Juno Co-Co Material Transfer Agreement Effective Date, and it is accepted and agreed to by the Parties’ authorized representatives.

 

For the Transferring Party:         For the Co-Co Materials Receiving Party:
By:  

 

        By:   

 

Name:  

 

        Name:   

 

Title:  

 

        Title:   

 

 

E - 3


EXHIBIT F

Juno Co-Co Commercialization Opt-In Terms

If (i) Celgene delivers a Celgene Co-Commercialization Notice to Juno pursuant to Section 3.1.2, Celgene shall have the right, and/or (ii) Juno exercises the Commercialization Opt-In Right pursuant to Sections 3.1.3, Juno shall have the right, in each case to participate in the following Commercialization Activities relating to the Commercialization of Juno Program Co-Co Product in the Major EU Market Countries (where Juno exercises the Commercialization Opt-In Right), or the North America Territory (where Celgene delivers a Co-Commercialization Notice to Juno), and in such case the following terms shall apply to the conduct of the Commercialization Activities:

1.1 Commercialization Lead Party Responsibilities. Following the exercise of the Commercialization Opt-In Right by Juno, or the delivery of the Celgene Co-Commercialization Notice by Celgene, the applicable Commercialization Lead Party shall remain responsible for:

(a) the form and content of the Commercialization Plan for Commercialization of Juno Program Co-Co Products for Juno Territory Administration (where Juno is the Commercialization Lead Party) and for Celgene Territory Administration (where Celgene is the Commercialization Lead Party), [***], in accordance with Section 3.1.6, for all activities relating to the Commercialization of Juno Program Co-Co Products;

(b) booking all sales of Juno Program Co-Co Products in the relevant territory;

(c) execution of [***], including [***], and [***];

(d) all market access activities, including [***] in the relevant territory.

1.2 Commercialization Activities. The Party opting-in shall have the right to participate in certain Commercialization Activities relating to the Juno Program Co-Co Products as set forth in Section 3.1.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

F - 1


EXHIBIT G

Form of Press Release


EXHIBIT H

Certain U.S. Federal Income Tax Matters

[***]

 

[***] Seven pages have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


SCHEDULE 3.1.7(b)

Minimum Juno and Celgene Sales Representative Qualifications

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


SCHEDULE 6.1.1

Patents Licensed to Celgene


SCHEDULE 6.1.2

Patents Licensed to Juno


EXHIBIT C

FORM OF CELGENE LEAD CO-CO AGREEMENT

CELGENE LEAD CO-DEVELOPMENT AND CO-COMMERCIALIZATION AGREEMENT

by and among

[                    ]

and

[                             ]

and

[                                     ]

Dated as of [ ], [ ]


TABLE OF CONTENTS

 

          Page  

ARTICLE 1 DEFINITIONS

     2   

1.1

   “Celgene Co-Co Annual Net Sales”      2   

1.2

   “Celgene Co-Co Combination Product”      2   

1.3

   “Celgene Co-Co Commercialization Plan”      2   

1.4

   “Celgene Co-Co Development Budget”      2   

1.5

   “Celgene Co-Co Development Plan”      2   

1.6

   “Celgene Co-Co Net Sales”      2   

1.7

   “[***]”      3   

1.8

   “Celgene Program Co-Co IP”      3   

1.9

   “Celgene Program Co-Co Product Data”      3   

1.10

   “Celgene Co-Co Regulatory-Based Exclusivity”      4   

1.11

   “Commercialization Opt-In Terms”      4   

1.12

   “First Celgene Program Co-Co Sale”      4   

1.13

   “Juno Relevant Co-Co IP”      5   

1.14

   “NA Territory Administration”      5   

1.15

   “ROW Territory Administration”      5   

1.16

   Additional Definitions.      5   

1.17

   Definitions from Master Collaboration Agreement.      7   

ARTICLE 2 DEVELOPMENT; REGULATORY; MANUFACTURE

     10   

2.1

   Celgene Co-Co Program, Celgene Program Co-Co Target and Candidates.      10   

2.2

   Development.      10   

2.3

   Regulatory.      16   

2.4

   Manufacturing and Supply.      19   

2.5

   Records; Reports; Results.      19   

2.6

   Materials Transfer; License.      20   

2.7

   No Representation.      21   

2.8

   Covenant During Celgene Co-Co Term.      21   

ARTICLE 3 COMMERCIALIZATION; JUNO RIGHT TO OPT IN

     22   

3.1

   Commercialization.      22   

3.2

   Additional Terms.      26   

ARTICLE 4 EXCLUSIVITY

     27   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

i


          Page  

4.1

   Exclusivity.      27   

ARTICLE 5 FINANCIAL TERMS

     27   

5.1

   Option Exercise and Designation Payments.      27   

5.2

   Profit & Loss Share for Celgene Program Co-Co Product.      27   

5.3

   Discounted Sales.      28   

5.4

   Additional Payment Terms.      28   

ARTICLE 6 INTELLECTUAL PROPERTY

     30   

6.1

   License.      30   

6.2

   Ownership.      32   

6.3

   Prosecution and Maintenance of Patents.      32   

6.4

   Defense of Claims Brought by Third Parties.      32   

6.5

   Enforcement of Patents.      33   

6.6

   Patent Term Extensions.      36   

6.7

  

[***].

     37   

6.8

   [***] Patents.      37   

6.9

   Regulatory Data Protection.      37   

6.10

   Third Party Licenses.      37   

ARTICLE 7 UPSTREAM AGREEMENTS

     38   

7.1

   Upstream Obligations.      38   

ARTICLE 8 INDEMNIFICATION; INSURANCE

     38   

8.1

   Indemnification by Juno.      38   

8.2

   Indemnification by Celgene.      38   

8.3

   Notice of Claims.      38   

8.4

   Indemnification Procedures.      39   

8.5

   Celgene Co-Co Program Administration Liabilities.      40   

8.6

   LIMITATION OF LIABILITY.      40   

ARTICLE 9 Celgene CO-CO TERM AND TERMINATION

     40   

9.1

   Celgene Co-Co Term; Expiration.      40   

9.2

   Termination Without Cause.      41   

9.3

   Termination for Breach.      41   

9.4

   Termination for Patent Challenges.      42   

9.5

   Termination for Bankruptcy.      43   

9.6

   Termination for Breach of Standstill.      43   

9.7

   Effects of Expiration or Termination.      43   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-ii-


          Page  

9.8

   Celgene Program Co-Co Reversion Products.      44   

9.9

   Survival of Sublicenses.      46   

9.10

   Surviving Provisions.      46   

9.11

   Relationship to Other Agreements.      47   

ARTICLE 10 MISCELLANEOUS

     47   

10.1

   Confidentiality; Publicity.      47   

10.2

   Disclaimer of Warranties.      47   

10.3

   Applicability of Terms of Master Collaboration Agreement.      48   

10.4

   Assignment.      48   

10.5

   Entire Agreement.      49   

 

-iii-


LIST OF EXHIBITS

 

Exhibit A    Celgene Co-Co Program
Exhibit B    Celgene Program Co-Co Target, Celgene Program Co-Co Candidates and [***]
Exhibit C    Designation Payments for Celgene Co-Co Programs
Exhibit D    Profit & Loss Share
Exhibit E    Form of Co-Co Material Transfer Agreement
Exhibit F    Commercialization Opt-In Terms
Exhibit G    Form of Press Release
Exhibit H    Certain U.S. Federal Income Tax Matters

LIST OF SCHEDULES

 

Schedule 3.1.6(b)    Minimum Sales Representative Qualifications
Schedule 6.1.1    Patents Licensed to Juno
Schedule 6.1.2    Patents Licensed to Celgene

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


CELGENE LEAD CO-CO AGREEMENT

This CELGENE LEAD CO-DEVELOPMENT AND CO-COMMERCIALIZATION AGREEMENT (this “ Celgene Lead Co-Co Agreement ”) is entered into and made effective as of [●], 20      (the “ Celgene Lead Co-Co Agreement Effective Date ”) by and among Juno Therapeutics, Inc. , a Delaware corporation (“ Juno ”), and Celgene Corporation , a Delaware corporation (“ Celgene Corp. ”), with respect to all rights and obligations under this Celgene Lead Co-Co Agreement in the United States, and Celgene RIVOT Ltd. (“ Celgene RIVOT ”), with respect to all rights and obligations under this Celgene Lead Co-Co Agreement outside of the United States, (Celgene RIVOT and Celgene Corp. together, “ Celgene ”). Juno and Celgene are each referred to herein as a “ Party ” or, collectively, as the “ Parties .”

RECITALS

WHEREAS, Juno, Celgene Corp. and Celgene RIVOT entered into that certain Master Research and Collaboration Agreement, dated as of June 29, 2015 (as amended, the “ Master Collaboration Agreement ”), pursuant to which Juno has an exclusive option to obtain certain rights to participate in the development and commercialization of Development Candidates and Products arising out of activities conducted pursuant to certain Celgene Programs, [***] Programs and Eligible BD Programs in the North America Territory and upon Juno’s election under certain circumstances, in the Major EU Market Countries (each, as defined in the Master Collaboration Agreement) and to share profits and losses arising from the development and commercialization of such Development Candidates and Products on a worldwide basis;

WHEREAS, pursuant to the terms of the Master Collaboration Agreement, upon exercise by Juno of its Option with respect to a Celgene Program or an [***] Program offered by Celgene, or the exercise by Juno of a BD Option with respect to a [***] BD Program (in each case, as such terms are defined in the Master Collaboration Agreement), the Parties are obligated to enter into a co-development and co-commercialization agreement within a period of time specified in the Master Collaboration Agreement, with respect to such Celgene Program, [***] Program or [***] BD Program, as applicable;

WHEREAS, Juno has delivered an Option Exercise Notice pursuant to Section 3.1.3 or Section 3.1.5 of the Master Collaboration Agreement for the Celgene Program or [***] Program offered by Celgene (as applicable), or a BD Option Exercise Notice for a [***] BD Program pursuant to Section 2.2.1 of the Master Collaboration Agreement, and accordingly, Juno and Celgene are obligated to enter into this Celgene Lead Co-Co Agreement with respect thereto; and

WHEREAS, pursuant to this Celgene Lead Co-Co Agreement, Celgene grants to Juno certain rights to participate in the Development, Manufacture and Commercialization of the Celgene Development Candidates (as defined in the Master Collaboration Agreement) for such Celgene Co-Co Program (the “ Celgene Program Co-Co Candidates ”), and Co-Co Products (as defined in the Master Collaboration Agreement) for such Celgene Co-Co Program (the “ Celgene Program Co-Co Products ”) in the North America Territory, and (if Juno elects to opt-in under certain circumstances) in the Major EU Market Countries).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


NOW, THEREFORE, in consideration of the foregoing and the mutual agreements set forth below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

ARTICLE 1

DEFINITIONS

Capitalized terms used, but not defined, herein will have the meanings ascribed to them in the Master Collaboration Agreement.

1.1 “Celgene Co-Co Annual Net Sales” means, on a Celgene Program Co-Co Product-by-Celgene Program Co-Co Product and Celgene Program Co-Co Diagnostic Product-by-Celgene Program Co-Co Diagnostic Product basis, total Celgene Co-Co Net Sales by Celgene, its Affiliates and Sublicensees in the Territory of such Celgene Program Co-Co Product or Celgene Program Co-Co Diagnostic Product in a particular [***].

1.2 “Celgene Co-Co Combination Product” means any Celgene Program Co-Co Product comprising a Celgene Program Co-Co Candidate and one or more other active ingredient(s) that is not itself a Celgene Program Co-Co Candidate (such other active ingredients, “Other Actives”). For clarification, the term “Other Active,” when referring to an ingredient included in such Celgene Program Co-Co Product refers to ingredients that are incorporated or included in the Celgene Program Co-Co Product for [***] (whether in the same or different formulations, or dosed separately or together) for the purpose of [***]; the term excludes such ingredients that are present in such a Celgene Program Co-Co Product [***].

1.3 “Celgene Co-Co Commercialization Plan” means the plan that specifies the Parties’ responsibilities for the Commercialization of Celgene Program Co-Co Product in the Territory during a given Calendar Year and the [***] succeeding Calendar Years.

1.4 “Celgene Co-Co Development Budget” means, on a Celgene Program Co-Co Product-by-Celgene Program Co-Co Product basis, the budget for conducting Development of such Celgene Program Co-Co Products (and corresponding Celgene Program Co-Co Candidates) in the Territory, pursuant to the Celgene Co-Co Development Plan, during a given Calendar Year and [***] succeeding Calendar Years, as prepared by Celgene and approved by the JRDC in accordance with Section 2.2.7.

1.5 “Celgene Co-Co Development Plan” means, on a Celgene Program Co-Co Product-by-Celgene Program Co-Co Product basis, the plan for the Development of such Celgene Program Co-Co Product (and corresponding Celgene Program Co-Co Candidates) in the Territory during a given Calendar Year and the [***] succeeding Calendar Years, as prepared by Celgene and approved by the JRDC in accordance with Section 2.2.4.

1.6 “Celgene Co-Co Net Sales” means, with respect to any Celgene Program Co-Co Product or Celgene Program Co-Co Diagnostic Product, the [***] amounts [***] by Celgene, its Affiliates and Sublicensees (each, a “ Celgene Co-Co Selling Party ”) to Third Party customers for sales of such Celgene Program Co-Co Product or Celgene Program Co-Co Diagnostic

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2


Product, less the following deductions [***] in accordance with (as applicable to the Celgene Co-Co Selling Party) the Accounting Principles, for:

(a) [***];

(b) [***];

(c) [***];

(d) [***];

(e) [***]; and

(f) [***].

If non-monetary consideration is received by a Celgene Co-Co Selling Party for any Celgene Program Co-Co Product or Celgene Program Co-Co Diagnostic Product in the relevant country, Celgene Co-Co Net Sales will be calculated based on the [***]. Notwithstanding the foregoing, Celgene Co-Co Net Sales shall not be imputed to transfers of Celgene Program Co-Co Products or Celgene Program Co-Co Diagnostic Product, as applicable, for use in [***].

Celgene Co-Co Net Sales shall be determined on, and only on, the first sale by Celgene or any of its Affiliates or Sublicensees to a non-Sublicensee Third Party.

If a Celgene Program Co-Co Product is sold as part of a Celgene Co-Co Combination Product, Celgene Co-Co Net Sales will be the product of (i) Celgene Co-Co Net Sales of the Celgene Co-Co Combination Product calculated as above (i.e., calculated as for a non-Celgene Co-Co Combination Product) and (ii) the fraction [***], where:

[***]

1.7 “[***]” means, solely for purposes of [***].

1.8 “Celgene Program Co-Co IP” means, with respect to the Celgene Co-Co Program, (a) all Celgene IP Controlled by Celgene and/or its Affiliates as of the Celgene Lead Co-Co Agreement Effective Date or at any time thereafter during the Celgene Co-Co Term that (i) [***] (1) Celgene Program Co-Co Candidates, (2) Celgene Program Co-Co Products and/or (3) Diagnostic Products for such Celgene Program Co-Co Candidates or Celgene Program Co-Co Products (such Diagnostic Products, the “ Celgene Program Co-Co Diagnostic Products ”) or (ii) [***], including any such [***], and in each case subject to the following sentence. Notwithstanding anything to the contrary in this Section 1.8, Patents included in the Celgene Program Co-Co IP shall not include (A) any Patents to the extent such Patents [***], or (B) any Patents to the extent such Patents [***].

1.9 “Celgene Program Co-Co Product Data” means all relevant data included in the Know-How Controlled by either Party or its Affiliates in relation to the Celgene Program Co-Co Products and/or Celgene Program Co-Co Diagnostic Products for use in the Field that: (a) is

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

3


in existence at the Celgene Lead Co-Co Agreement Effective Date; or (b) is generated from activities conducted by or on behalf of a Party under the Celgene Co-Co Development Plan or otherwise specifically relates to Celgene Program Co-Co Products and/or Celgene Program Co-Co Diagnostic Products and in each case is [***] for Regulatory Approval, or Regulatory Approvals, for Celgene Program Co-Co Products in the Field and in the Territory.

1.10 “Celgene Co-Co Regulatory-Based Exclusivity” means, on a Celgene Program Co-Co Product-by-Celgene Program Co-Co Product and country-by-country basis, that (a) Celgene or any of its Affiliates or Sublicensees has been granted the exclusive legal right by a Regulatory Authority (or is otherwise entitled to the exclusive legal right by operation of Law) in such country to market and sell the Celgene Program Co-Co Product or the active ingredient comprising such Celgene Program Co-Co Product in such country, or (b) the data and information submitted by Celgene or any of its Affiliates or Sublicensees to the relevant Regulatory Authority in such country for purposes of obtaining Regulatory Approval for such Celgene Program Co-Co Product may not be disclosed, referenced or relied upon in any way by any Person to support the Regulatory Approval or marketing of any product by a Third Party in such country other than (i) Celgene, its Affiliates or Sublicensees, or (ii) solely to the extent permitted in this Celgene Lead Co-Co Agreement, Juno, its Affiliates or Sublicensees (including in each case by relying upon the Regulatory Authority’s previous findings regarding the safety or effectiveness of the Celgene Program Co-Co Product).

1.11 “Commercialization Opt-In Terms” means the additional terms of participation by Juno in Commercialization Activities relating to Celgene Program Co-Co Product following Juno’s delivery of a Juno Co-Commercialization Notice to participate in co-Commercialization of Celgene Program Co-Co Products pursuant to Section 3.1.2 with respect to the North America Territory or Major EU Market Countries.

1.12 “First Celgene Program Co-Co Sale” means, on a Celgene Program Co-Co Product-by-Celgene Program Co-Co Product and Celgene Program Co-Co Diagnostic Product-by-Celgene Program Co-Co Diagnostic Product basis, the first sale [***] by Celgene or its Affiliates or Sublicensees for use or consumption by [***] of such Celgene Program Co-Co Product or Celgene Program Co-Co Diagnostic Product, as applicable, in a country for which [***] Regulatory Approvals [***] in order to sell such Celgene Program Co-Co Product (or Celgene Program Co-Co Diagnostic Product, as applicable) in the [***] have been granted; in each case, provided, however, that the following shall not constitute a First Celgene Program Co-Co Sale: (a) any sale to an Affiliate or Sublicensee unless the Affiliate or Sublicensee is the last entity in the distribution chain of the Celgene Program Co-Co Product or Celgene Program Co-Co Diagnostic Product, as applicable; (b) any use of such Celgene Program Co-Co Product or Celgene Program Co-Co Diagnostic Product in Clinical Trials, non-clinical development activities or other development activities with respect to such Celgene Program Co-Co Product or Celgene Program Co-Co Diagnostic Product by or on behalf of a Party, or disposal or transfer of such Celgene Program Co-Co Product or Celgene Program Co-Co Diagnostic Product for a bona fide charitable purpose; and (c) compassionate use, in each case for which no payment is received by Celgene, its Affiliates or Sublicensees.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

4


1.13 “Juno Relevant Co-Co IP” means, with respect to the Celgene Co-Co Program, (a) all Juno IP Controlled by Juno and/or its Affiliates as of the Celgene Lead Co-Co Agreement Effective Date or at any time thereafter during the Celgene Co-Co Term that (i) [***] (1) Celgene Program Co-Co Candidates, (2) Celgene Program Co-Co Products and/or (3) Celgene Program Co-Co Diagnostic Products for such Celgene Program Co-Co Candidates or Celgene Program Co-Co Products or (ii) [***], including in each case any such [***], and in each case subject to the following sentence. Notwithstanding anything to the contrary in this Section 1.13, Patents included in the Juno Relevant Co-Co IP shall not include (A) any Patents to the extent such Patents [***], or (B) any Patents to the extent such Patents [***].

1.14 “NA Territory Administration” means administration of a Celgene Program Co-Co Product to a patient when such patient is located outside of the ROW Territory and any use of related Celgene Program Co-Co Diagnostic Products outside of the ROW Territory.

1.15 “ROW Territory Administration” means administration of a Celgene Program Co-Co Product to a patient when such patient is located in the ROW Territory and any use of related Celgene Program Co-Co Diagnostic Products outside of the ROW Territory.

1.16 Additional Definitions. Each of the following terms has the meaning described in the corresponding section of this Celgene Lead Co-Co Agreement indicated below:

 

Defined Term:

   Section:

Allocable Overhead

   Exhibit D

Allowable Expenses

   Exhibit D

[***]

   5.2.3

Breach Damages

   9.7.2

[***]

   2.2.5(b)(4)

Celgene

   Preamble

Celgene Co-Co Additional Study

   2.2.5(b)

[***]

   2.2.5(b)(4)

Celgene Co-Co BD Program

   5.2.2

Celgene Co-Co BD Program Profit & Loss Share

   5.2.2

[***]

   2.2.6

Celgene Co-Co Commercialization Budget

   3.1.7(a)

Celgene Co-Co Commercialization Report

   3.2.3

[***]

   2.2.5(b)(4)

Celgene Co-Co Development Costs

   Exhibit D

Celgene Co-Co [***] Programs

   5.2.1

Celgene Co-Co [***] Profit and Loss Share

   5.2.1

Celgene Co-Co Material Transfer Agreement

   2.6.1

Celgene Co-Co Material Transfer Agreement Effective Date

   Exhibit E

Celgene Co-Co Materials

   2.6.1

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

5


Defined Term:

   Section:

Celgene Co-Co Materials Receiving Party

   2.6.1

Celgene Co-Co Program

   Exhibit A

Celgene Co-Co Program Assets

   2.8

Celgene Co-Co Purpose

   2.6.1

Celgene Co-Co Research Cost Allocation

   2.2.1

Celgene Co-Co Selling Party

   1.6

Celgene Co-Co Term

   9.1.1

Celgene Co-Co Transferring Party

   2.6.1

Celgene Corp.

   Preamble

Celgene Lead Co-Co Agreement

   Preamble

Celgene Lead Co-Co Agreement Effective Date

   Preamble

Celgene Program Co-Co Candidates

   Recitals; Exhibit B

Celgene Program Co-Co Competitive Infringement

   6.5.1

Celgene Program Co-Co Covering Patent

   6.6

Celgene Program Co-Co Diagnostic Products

   1.8

Celgene Program Co-Co Enforcement Proceeding

   6.5.3

Celgene Program Co-Co Products

   Recitals

Celgene Program Co-Co Product Patents

   6.5.2(b)

Celgene Program Co-Co Reversion Products

   9.8.1

Celgene Program Co-Co Step-In Proceeding

   6.5.3

Celgene Program Co-Co Target

   Exhibit B

Celgene Program Co-Commercialization Territory Administration

   8.5

Celgene Program Co-Commercialization Territory Administration Liabilities

   8.5

Celgene RIVOT

   Preamble

Commercialization Lead Party

   3.1.1

Cost of Goods Sold or COGS

   Exhibit D

Cure Period

   9.3.1

Distribution Costs

   Exhibit D

Gross Profit

   Exhibit D

Indemnification Claim

   8.3

Indemnitee

   8.3

Indemnitor

   8.3

[***]

   5.4.3(b)

Information Request

   3.1.6(d)

Juno

   Preamble

Juno Co-Commercialization Notice

   3.1.2

[***]

   2.2.5(b)(4)

Manufacturing Costs

   Exhibit D

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

6


Defined Term:

   Section:

Marketing Costs

   Exhibit D

Master Collaboration Agreement

   Recitals

Material Breach Damages

   9.7.2

Operating Profits or Losses

   Exhibit D

Other Actives

   1.5

Other Operating Income/Expenses

   Exhibit D

Package

   5.3

Party or Parties

   Preamble

Patent Term Extension

   6.6

Payee Party

   5.4.3(b)

Paying Party

   5.4.3(b)

Pharmacovigilance Agreement

   2.3.4(a)

Pharmacovigilance Expenses

   Exhibit D

Product Recall Expenses

   Exhibit D

Profit & Loss Share

   5.2

Recording Party

   Exhibit D

Regulatory Expenses

   Exhibit D

Report

   Exhibit D

Research Cost Report

   2.2.7(c)

Safety and CMC Data

   2.3.2(b)

Sales Costs

   Exhibit D

Sublicense Revenues

   Exhibit D

1.17 Definitions from Master Collaboration Agreement.

Capitalized terms used herein but not defined, including each of the following terms, have the meaning described in the Master Collaboration Agreement:

 

Defined Term:

Accounting Principles

Affiliate

Antitrust Law

Bankruptcy Code

BD Acquiring Party

BD Evaluation Period

BD Opt-In Payment

BD Option Exercise Notice

Biologics License Application or BLA

Business Combination

Business Day

Calendar Quarter

Calendar Year

 

7


Defined Term:

CAR

[***] BD Program

Celgene Background IP

Celgene Co-Promote Program

Celgene Indemnitees

Celgene IP

Celgene Patents

Celgene Platform Technology

Celgene Program

Celgene Program Assets

[***] BD Program

[***] Program

Celgene Upstream Agreements

Cellular Therapy Products

Claims

Clinical Trial

CMC Activities

Co-Co Product

Collaboration IP

Commercialization

Commercialization Activities

Commercialization Lead Party

Commercialization Opt-In Right

Commercially Reasonable Efforts

Confidential Information

Control, Controls or Controlled

Core Dossier Studies

Cover, Covering or Covered

Damages

[***]

Development

Development & Commercialization Agreement

Development Candidate

Development Plan

Development Lead Party

Diagnostic Product

Dollars or $

EMA

Equity Purchase Agreement

Executive Officers

FDA

Field

FTE Rate

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

8


Defined Term:

Good Clinical Practices or GCP

Good Laboratory Practices or GLP

Good Manufacturing Practices or GMP

Hatch-Waxman Act

[***] Agent or [***]

In Vivo Product

IND

Indication

Inventions

Joint Collaboration IP

JRDC

JSC

Juno Background IP

Juno Indemnitees

Juno Option Exercise Notice

Juno Patents

Juno Platform Technology

Juno Program

Juno Upstream Agreements

JRDC

Hatch-Waxman Act

Know-How

Law or Laws

Litigation Conditions

MAA

Major EU Market Countries

Manufacture or Manufacturing

Manufacturing Agreement

New Drug Application or NDA

North America Territory

Offering Party

Option

Option Exercise Notice

Patent

Patent Committee

Person

Phase 3 Clinical Trial

Phase 4 Clinical Trial

Post Option Costs

Products

Product Liability

Program

Prosecution and Maintenance

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

9


Defined Term:

[***]

Regulatory Approval

Regulatory Authority

Regulatory Lead Party

Regulatory Materials

Reimbursable Costs

Resulting Patents

Research

ROW Territory

Small Molecule Compounds

Specifically Directed

Sublicensees

Target

Territory

Third Party

Third Party License

[***] BD Program

[***] Program

[***] Option Exercise Notice

[***] Program

United States or U.S.

ARTICLE 2

DEVELOPMENT; REGULATORY; MANUFACTURE

2.1 Celgene Co-Co Program, Celgene Program Co-Co Target and Candidates .

2.1.1 Celgene Co-Co Program . The Celgene Co-Co Program is the Program set forth on Exhibit A .

2.1.2 Celgene Program Co-Co Target . The Celgene Program Co-Co Target is set forth on Exhibit B .

2.1.3 Celgene Program Co-Co Candidates . The Celgene Program Co-Co Candidates, as of the Celgene Lead Co-Co Agreement Effective Date, are set forth on Exhibit B .

2.1.4 [***] . The [***] under this Celgene Lead Co-Co Agreement are set forth on Exhibit B , as such list of [***] may be amended from time to time.

2.2 Development .

2.2.1 Roles and Responsibility . As of and after the Celgene Lead Co-Co Agreement Effective Date, except as set forth in Sections 2.2.5, 3.1.2, and 3.1.3, Celgene will assume primary responsibility for, and shall be the Development Lead Party and the

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

10


Commercialization Lead Party for Celgene Program Co-Co Candidates, Celgene Program Co-Co Products and Celgene Program Co-Co Diagnostic Products in the Territory for both NA Territory Administration and ROW Territory Administration. Juno will reasonably cooperate with Celgene in performing such Development activities as are allocated to Juno in the North America Territory pursuant to the Celgene Co-Co Development Plan. Within [***] following the Celgene Lead Co-Co Agreement Effective Date, the Parties shall convene a meeting of the JRDC to discuss the Celgene Co-Co Development Plan for the Celgene Co-Co Program, and for the JRDC to allocate roles and responsibility to each Party for the conduct of Development and regulatory activities (including pursuant to Section 2.3) with respect to Celgene Program Co-Co Candidates and Celgene Program Co-Co Products for NA Territory Administration. Without limiting the foregoing, within [***] following the Celgene Lead Co-Co Agreement Effective Date, the JRDC shall discuss and define the scope of Research activities that are to be conducted by the Parties in relation to the Celgene Program Co-Co Candidates and Celgene Program Co-Co Products in each case falling within [***] for the Celgene Co-Co Program following the Celgene Lead Co-Co Agreement Effective Date, and related budgets therefor. All such Research activities and the allocation of responsibility therefor between the Parties shall be set forth in a Research plan component of the Celgene Co-Co Development Plan. The costs of conducting the Research activities that are agreed by the JRDC in both the ROW Territory and the North America Territory in relation to the Celgene Co-Co Program shall be reflected in a Research budget approved with the applicable Research plan. The costs incurred by either Party in conducting Research activities in accordance with the Research plan will be [***] based on the nature of the Celgene Co-Co Program under which such Research is conducted or to be conducted, as set forth in Section 5.2 and Exhibit D (the “ Celgene Co-Co Research Cost Allocation ”). Unless the Parties otherwise agree in writing, [***].

2.2.2 Diligence . Celgene, directly or through one or more of its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to Develop and Commercialize Celgene Program Co-Co Products in the ROW Territory for ROW Territory Administration and in the North America Territory for NA Territory Administration and otherwise perform its obligations under the Celgene Co-Co Development Plan. Juno, directly or through one or more of its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to perform the Development activities allocated to Juno under the Celgene Co-Co Development Plan and to perform any Commercialization Opt-In Activities assigned to Juno pursuant to Section 3.1.2 and 3.1.3. Celgene, directly or through one or more of its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to Manufacture Celgene Program Co-Co Products that are [***] Products for clinical and commercial purposes for NA Territory Administration and ROW Territory Administration as set forth in Section 2.4. Juno, directly or through one or more of its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to Manufacture [***] Products for NA Territory Administration arising under the Celgene Co-Co Program, if any, and to perform services with respect to [***] Products for ROW Territory Administration arising under the Celgene Co-Co Program, if any, as set forth in Section 2.4 of this Celgene Lead Co-Co Agreement and Section 2.10 of the Master Collaboration Agreement. Each Party will reasonably cooperate with the other Party in performing the foregoing obligations.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

11


2.2.3 Assistance . During the Celgene Co-Co Term, Celgene will cooperate with Juno to provide reasonable assistance requested by Juno to facilitate any Development and Commercialization efforts allocated to Juno pursuant to the Celgene Co-Co Development Plan and the Celgene Co-Co Commercialization Plan (including following election by Juno pursuant to Section 3.1.2 or exercise by Juno of the Commercialization Opt-In Right pursuant to Section 3.1.3) related to Celgene Program Co-Co Candidates, Celgene Program Co-Co Products and Celgene Program Co-Co Diagnostic Products, including assistance with respect to regulatory and Clinical Trial transition matters, if applicable[***]. Such cooperation will include providing Juno with reasonable access in-person or by teleconference to Celgene’s personnel involved in the Research, Development and Manufacture of Celgene Program Co-Co Candidates, Celgene Program Co-Co Products and Celgene Program Co-Co Diagnostic Products.

2.2.4 Development Plan .

(a) Scope and Preparation . Promptly after the Celgene Lead Co-Co Agreement Effective Date, Celgene shall prepare and submit to the JRDC for review and approval an initial global Celgene Co-Co Development Plan for Celgene Program Co-Co Products, including [***] the JRDC determines are then ongoing, if any, and any [***] in the North America Territory and the ROW Territory pursuant to the Celgene Co-Co Program, as well as all other Clinical Trials and other studies to be conducted in relation to Celgene Program Co-Co Product pursuant to this Celgene Lead Co-Co Agreement pursuant to Sections 2.2.5 and 2.2.6. All [***] incurred by either Party or its Affiliates in conducting (i) Development activities pursuant to the Celgene Co-Co Development Plan, (ii) [***] for Celgene Program Co-Co Products following the Celgene Lead Co-Co Agreement Effective Date, or (iii) [***] pursuant to Section 2.2.5 following the Celgene Lead Co-Co Agreement Effective Date shall be [***], and shall be [***]. [***] will set the required form and contents of the Celgene Co-Co Development Plan, and will [***] each Celgene Co-Co Development Plan. The Celgene Co-Co Development Plan shall incorporate any reasonable comments made by either Party in relation to the Development of Celgene Program Co-Co Products.

(b) Updates . Following the initial preparation of the Celgene Co-Co Development Plan as set forth in Section 2.2.4(a), Celgene will provide the JRDC with updates to the Celgene Co-Co Development Plan [***] (at a time to be mutually agreed by the Parties) during the Celgene Co-Co Term prior to the grant of Regulatory Approval for the applicable Celgene Program Co-Co Products. Celgene shall provide such update to the JRDC at least [***] in advance of the applicable JRDC meeting, and shall incorporate any reasonable comments by either Party with respect to such Celgene Co-Co Development Plan. In addition, either Party may reasonably request at any time that Celgene consider and incorporate other updates to the Celgene Co-Co Development Plan for Development activities to support Regulatory Approval, including any Celgene Co-Co Additional Study that the Parties agree to conduct pursuant to Section 2.2.5(b)(1). Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will perform any material Development activities for any Celgene Program Co-Co Candidates, Celgene Program Co-Co Products or Celgene Program Co-Co Diagnostic Products unless described in the Celgene Co-Co Development Plan, as specified in Section 2.2.5 or required by applicable laws or applicable Regulatory Authorities or independent monitoring boards for Clinical Trials.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

12


2.2.5 Conduct of Certain Development Activities . Notwithstanding Sections 2.2.3 and 2.2.4:

(a) Ongoing Clinical Trials . If Celgene was conducting a Clinical Trial(s) with respect to any Celgene Program Co-Co Candidate and/or Celgene Program Co-Co Product under the Collaboration which has not been completed as of the Celgene Lead Co-Co Agreement Effective Date, including [***], then Celgene will continue to be responsible for the performance of such Clinical Trial(s), and the [***] following the Celgene Lead Co-Co Agreement Effective Date shall be [***]; and

(b) New Clinical Trials and Other Studies . If, following the Celgene Lead Co-Co Agreement Effective Date, Celgene wishes (i) to propose to conduct a Clinical Trial or other study of Celgene Program Co-Co Products in the Territory, (ii) to propose to Develop Celgene Program Co-Co Products in the North America Territory and/or the ROW Territory for any Indication in the Field other than an Indication for which such Celgene Program Co-Co Products are being Developed pursuant to the Celgene Co-Co Development Plan, (iii) to propose to Develop a dosage form or formulation of Celgene Program Co-Co Products in the North America Territory and/or the ROW Territory other than that being studied in the Celgene Co-Co Development Plan, or (iv) to propose to conduct any other Clinical Trial of a Celgene Program Co-Co Product in the Field, including any Clinical Trial that the JRDC determines is a [***], or any Clinical Trial or study that is not otherwise set forth in the Celgene Co-Co Development Plan, including any Clinical Trial Celgene believes may have utility to support Regulatory Approval on a global basis and any Phase 4 Clinical Trial (each such study not already included in a Celgene Co-Co Development Plan, a “ Celgene Co-Co Additional Study ”), then (A) Celgene shall first provide the proposed trial design and protocol for such Celgene Co-Co Additional Study to JRDC [***] as to the [***] of such Celgene Co-Co Additional Study, and shall incorporate [***], (B) following such review by the JRDC, Celgene shall provide the final proposed design and projected costs of such Celgene Co-Co Additional Study to the JRDC, and (C) the following shall apply:

(1) If Juno, through its members of the JRDC, agrees that such Celgene Co-Co Additional Study should be conducted, the Parties shall amend the Celgene Co-Co Development Plan and the Celgene Co-Co Development Budget to include such Celgene Co-Co Additional Study, and the [***] such Celgene Co-Co Additional Study shall be an Allowable Expense and shall be subject to the Profit & Loss Share pursuant to Section 5.2 and Exhibit D .

(2) If the Parties disagree on whether [***] such Celgene Co-Co Additional Study, then, subject to subsection (3), [***] shall have the final decision making right on whether the Parties will conduct such Celgene Co-Co Additional Study, subject to Section 2.2.5(b)(3).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(3) If [***] does not [***], then Celgene may proceed with such Celgene Co-Co Additional Study and would be solely responsible for the [***]).

(4) For any Celgene Co-Co Additional Study conducted that Juno does not wish to [***], or to [***] of such Celgene Program Co-Co Product for the Indication, formulation, dosage form or other attribute of such Celgene Program Co-Co Product that was the subject of such Celgene Co-Co Additional Study, if the data from such Celgene Co-Co Additional Study is [***], then upon such [***], Juno shall be deemed to have [***], and shall make the [***], with respect to such Celgene Co-Co Additional Study. Notwithstanding the foregoing, the following mechanism shall apply [***]: Upon [***], Juno shall [***], at Juno’s option, either (x) [***], or (y) [***]. If upon [***] to Celgene for a [***] for such Celgene Co-Co Additional Study is [***], then the remainder [***] shall be [***], provided that in no event shall [***], with any [***] to Juno to [***], always subject to [***].

(5) If Juno elects to [***] a Celgene Co-Co Additional Study, or elects to [***], or is subject to a [***] as set forth in this Section 2.2.5, then following Juno’s decision to [***], as applicable, all data resulting from such Celgene Co-Co Additional Study (including any Celgene Program Co-Co Product Data) would be available for use by each Party in connection with Celgene Program Co-Co Products in the Field in the North America Territory and the ROW Territory for the purpose of performing activities in accordance with the Celgene Co-Co Development Plan or otherwise as set forth in this Celgene Lead Co-Co Agreement.

2.2.6 [***] Right . Notwithstanding Section 2.2.5(b)(3) above, and subject to Section 2.2.5(b)(4), [***], Juno shall have the right to elect by written notice to Celgene to [***]. In such case, (a) the Parties shall [***] such Celgene Co-Co Additional Study [***], and (b) Juno shall [***] to conduct such Celgene Co-Co Additional Study [***]. Upon any such [***], the Parties shall have the rights with respect to such Clinical Trial or studies and the data arising therefrom as set forth in Sections 2.2.5(b)(5) and 2.3.2. If Juno elects [***] within [***] after Juno notifies Celgene in writing that it is exercising [***] pursuant to this Section 2.2.6.

2.2.7 Celgene Co-Co Development Budget and Costs .

(a) Promptly after the Celgene Lead Co-Co Agreement Effective Date, and concurrently with the preparation of the Celgene Co-Co Development Plan pursuant to Section 2.2.4, [***] shall prepare and submit to the JRDC for approval the Celgene Co-Co Development Budget. For Celgene Co-Co Development Costs to be incurred from and after the Celgene Lead Co-Co Agreement Effective Date, the JRDC will review and approve the Celgene Co-Co Development Budget reasonably in advance of the applicable Celgene Co-Co Development Costs being incurred (with the intent being to obtain such approval [***], where practicable). Thereafter, the [***] will update and provide the JSC with a copy of the Celgene Co-Co Development Budget, including the budgeted Celgene Co-Co Development Costs, each Calendar Year at a meeting of the JSC sufficiently in advance of the next Calendar Year so as to provide the Parties with an opportunity to budget accordingly, but in any event no later than [***] of

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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each Calendar Year during the Celgene Co-Co Term. The JSC will review and approve any such update or any other amendment to the Celgene Co-Co Development Budget. In addition, either Party may request at any time that the JSC consider and approve other updates to the Celgene Co-Co Development Budget.

(b) Subject to subsection (a) and Sections 2.2.5 and 2.2.6, all [***] arising from either Party’s conduct of Development with respect to the Celgene Co-Co Program in accordance with the Celgene Co-Co Development Plan and the Celgene Co-Co Development Budget shall be [***]. For clarity, this subsection (b) shall not apply to the [***], which [***].

(c) Promptly following the Celgene Lead Co-Co Agreement Effective Date, the JRDC shall agree upon a form of cost report to be prepared and submitted by each Party to the JRDC on a [***] basis setting forth the costs incurred by each Party in conducting Research activities in accordance with the Celgene Co-Co Development Plan and the Research budget in the [***] (the “ Research Cost Report ”). Within [***] after the end of each Calendar Quarter following the Celgene Lead Co-Co Agreement Effective Date (or the determination by the JRDC of the scope of Research activities to be conducted by the Parties under the Celgene Co-Co Development Plan, if later), each Party shall submit its Research Cost Report for the previous Calendar Quarter to the JRDC. [***].

2.2.8 Meetings and Reports . During the Celgene Co-Co Term:

(a) Committees . The JSC, the JMC, the JRDC, the Patent Committee and the JCC shall remain established as set forth in Article 4 of the Master Collaboration Agreement, and shall be responsible for performing the functions set forth in Article 4 of the Master Collaboration Agreement. Notwithstanding the foregoing, subject to Sections 2.2.5 and 2.2.6 with respect to Celgene Co-Co Additional Studies for which the Parties have agreed to include [***], and except for [***], the JSC and the JRDC shall serve solely as a forum for exchanging information and facilitating discussions. In each case, notwithstanding anything else to the contrary in Section 4.2.5 of the Master Collaboration Agreement, Celgene shall have the final decision making right with respect to all Research, Development and Commercialization Activities relating to the Celgene Co-Co Program in the North America Territory and the ROW Territory for any matters that are not resolved by the JSC within the time provided in Section 4.2.5 of the Master Collaboration Agreement, including with respect to [***]. For any matters arising in relation to Additional Studies for which [***] and for matters relating to [***], the [***];

(b) Status Reports . Each Party shall provide a reasonably detailed written progress report to the JRDC, at least [***], on the status of its activities and efforts with respect to the Celgene Co-Co Program, including the status of any Research activities, or any Celgene Program Co-Co Candidate being Developed and/or Commercialized under such Celgene Co-Co Program, including (to the extent not covered in the Celgene Co-Co Development Plan): (i) the design, status and results of any Clinical Trials (including any Core Dossier Studies and Additional Studies) and other studies of Celgene Program Co-Co Products; and (ii) any key Development or regulatory events, and any Regulatory Approvals filed for or

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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achieved, for Celgene Program Co-Co Products. Such report should be provided no later than [***] before the next scheduled meeting of the JRDC, in order to provide the JRDC the opportunity to review such report prior to such meeting.

2.3 Regulatory.

2.3.1 Responsibility . As of and after the Celgene Lead Co-Co Agreement Effective Date, Celgene will be the Regulatory Lead Party for Development, Manufacture and Commercialization of Celgene Program Co-Co Candidates, Celgene Program Co-Co Products and Celgene Program Co-Co Diagnostic Products in the Field in the North America Territory and the ROW Territory, and shall take full responsibility for preparing and filing the relevant Regulatory Materials and seeking Regulatory Approval in the North America Territory and the ROW Territory. During the Celgene Co-Co Term, and in addition to each Party’s obligations pursuant to Sections 2.2.8(b) and 2.3.2, Celgene shall keep Juno, through the JRDC, reasonably informed, through updates at each meeting of the JRDC, of material regulatory activities and events that occur with respect to Celgene Program Co-Co Candidates, Celgene Program Co-Co Products and Celgene Program Co-Co Diagnostic Products in the North America Territory and the ROW Territory.

2.3.2 Rights to Use Celgene Program Co-Co Product Data .

(a) Each Party, in performing activities relating to the Development and Commercialization of Celgene Program Co-Co Candidates and Celgene Program Co-Co Products in such country pursuant to the Celgene Co-Co Development Plan, shall keep accurate records of all Celgene Program Co-Co Product Data generated as a result of all activity by or on behalf of such Party in performing Development and Commercialization in relation to Celgene Program Co-Co Candidates and Celgene Program Co-Co Products, including any data generated pursuant to the Party’s activities under Section 2.2.5(b)(1). Each Party shall provide the other Party with copies of all such Celgene Program Co-Co Product Data Controlled by such Party during the term of this Celgene Lead Co-Co Agreement that is [***] the Development and Commercialization of Celgene Program Co-Co Products and Celgene Program Co-Co Candidates promptly following the generation of such Celgene Program Co-Co Product Data. Celgene Program Co-Co Product Data Controlled by Juno shall be included in the license grant to Celgene pursuant to Section 6.1.2, and Celgene Program Co-Co Product Data shall be included in the Celgene Know-How and licensed to Juno pursuant to Section 6.1.1.

(b) Notwithstanding anything to the contrary in this Celgene Lead Co-Co Agreement, each Party shall promptly provide to the other Party, [***], copies of and rights of reference to and use of all Celgene Program Co-Co Product Data that is Controlled by such Party, and that are relevant to or necessary to address issues relating to: (i) the safety of Celgene Program Co-Co Products for NA Territory Administration or ROW Territory Administration anywhere in the North America Territory and the ROW Territory, including data that is related to adverse effects experienced with Celgene Program Co-Co Candidates or Celgene Program Co-Co Products, or (ii) CMC Activities relating to Celgene Program Co-Co Candidates or Celgene Program Co-Co Products, and in each of (i) and (ii), that are required to be reported or made

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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available to Regulatory Authorities anywhere in the Territory, when and as such data become available (collectively, “ Safety and CMC Data ”). Each Party shall use the Safety and CMC Data provided to it pursuant to this Section 2.3.2(b) solely to Develop and Commercialize Celgene Program Co-Co Candidates, Celgene Program Co-Co Products and Celgene Program Co-Co Diagnostic Products in the Field (A) for Juno, in the North America Territory and the Major EU Market Countries (if Juno has exercised the Commercialization Opt-In Right pursuant to Section 3.1.3), and (B) for Celgene in the North America Territory for NA Territory Administration and the ROW Territory for ROW Territory Administration.

2.3.3 Communication with Regulatory Authorities . Subject to Sections 2.3.4 and 2.3.6, Celgene shall be responsible for handling all complaints and communications (including with Regulatory Authorities) relating to Celgene Program Co-Co Products for both NA Territory Administration and ROW Territory Administration. Without limiting the foregoing, Celgene shall promptly notify Juno (which may be through the JRDC or the JSC) of any material oral or written communications to or from Regulatory Authorities, and any Regulatory Materials or filings on matters related to the Celgene Program Co-Co Products, or which may reasonably be deemed to impact the Development, Manufacture, marketing, Regulatory Approval or Commercialization of Celgene Program Co-Co Products, and shall provide Juno with copies of any such material written communications within [***], or earlier as specified in the Pharmacovigilance Agreement, of receipt or delivery of such communication, as the case may be, or such earlier date as required by Applicable Laws, the FDA, the EMA or other relevant Regulatory Authority. In addition Celgene shall provide Juno with copies of Regulatory Materials, including any material regulatory filings or communications, at least [***] in advance of any proposed filing, and shall give Juno an opportunity to review and comment on such regulatory communications or filings. In addition to the foregoing, Celgene shall give Juno reasonable opportunity (not to be less than [***]) to review and comment on such Regulatory Materials or filings, or on any proposed response to any such oral or written communications to or from Regulatory Authorities prior to submitting any response thereto. Celgene shall consider in good faith any reasonable comments made by Juno in relation to such Regulatory Materials, provided that Celgene shall have the final decision-making right with respect to the nature and content of any Regulatory Materials, communications or filings throughout the North America Territory and the ROW Territory. Celgene shall provide Juno with a copy of the final response, filing or communications, as specified herein.

2.3.4 Pharmacovigilance; REMS .

(a) The Parties will enter into a pharmacovigilance agreement within [***] after the Celgene Lead Co-Co Agreement Effective Date that shall govern their obligations with respect to the exchange, handling and reporting of adverse events, other safety information and Celgene Program Co-Co Product complaints during Development and Commercialization of the Celgene Program Co-Co Products in the North America Territory and the ROW Territory (the “ Pharmacovigilance Agreement ”). In general, the Pharmacovigilance Agreement will provide that Celgene will be responsible for such obligations for Celgene Program Co-Co Products for NA Territory Administration and ROW Territory Administration. Celgene will deploy and administer any REMS or other safety monitoring activity implemented for the Celgene Program

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Co-Co Product in the Territory, and shall be responsible for all pharmacovigilance activities for the Celgene Program Co-Co Product in the Territory, and (iii) Celgene will establish and maintain a global safety database for Products that will contain all information and data arising from the Parties’ activities with respect to safety matters that is required to be contributed by each Party pursuant to the Pharmacovigilance Agreement, including information and data arising out of any REMS and safety monitoring activities.

(b) The Parties shall discuss, through the JRDC, and agree upon standard provisions reasonably acceptable to both Parties regarding: (i) [***] in connection with Celgene Program Co-Co Product that [***], and (ii) [***] which may result in the [***] each Party with respect thereto.

(c) Celgene shall inform Juno during the Celgene Co-Co Term, in accordance with the Pharmacovigilance Agreement, of the side effect profiles for Celgene Program Co-Co Candidates and Celgene Program Co-Co Products, including pregnancy and suspected pregnancy, damages, toxicity or sensitivity reactions associated with the use of any Celgene Program Co-Co Candidate or Celgene Program Co-Co Product, regardless of whether these effects are attributable to such Celgene Program Co-Co Candidate or Celgene Program Co-Co Product. Each Party shall have the right to take [***], including the right to [***] of such Celgene Program Co-Co Candidate or Celgene Program Co-Co Product, if there are [***], as determined in accordance with the Pharmacovigilance Agreement, [***].

(d) In accordance with the procedures established by the Parties under the Pharmacovigilance Agreement, each Party shall cooperate with the other Party and share information concerning the pharmaceutical safety of each Celgene Program Co-Co Candidate and Celgene Program Co-Co Product. Each Party shall: (i) promptly advise the other Party of [***] of such Celgene Program Co-Co Candidate or Celgene Program Co-Co Product and any actions taken in response to such information; (ii) promptly advise the other Party of [***] of such Celgene Program Co-Co Candidate or Celgene Program Co-Co Product or [***], as far as this concerns [***]; and (iii) timely provide the other Party with [***] such Celgene Program Co-Co Candidate or Celgene Program Co-Co Product of which [***], as far as this relates to [***] to perform their obligations or exercise their rights under this Celgene Lead Co-Co Agreement. Treatment of safety information, standard operating procedures and training, as well as a statement of respective regulatory obligations shall be agreed in the Pharmacovigilance Agreement.

2.3.5 Right of Reference . Juno and its Affiliates and Sublicensees shall have access to any data contained or referenced in any Regulatory Materials (including any Regulatory Approvals), including any Celgene Program Co-Co Product Data, Controlled by Celgene that are necessary for the Development, Manufacture or Commercialization (in each case [***] to perform its obligations under the Co-Co Development Plan and the Co-Co Commercialization Plan pursuant to this Celgene Lead Co-Co Agreement) with respect to Celgene Program Co-Co Candidates and Celgene Program Co-Co Products, and Celgene Program Co-Co Diagnostic Products in the North America Territory, and in the Major EU Market Countries, if Juno exercises the Commercialization Opt-In Right pursuant to Section 3.1.3.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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2.3.6 Compliance .

(a) Obligations . Each of Juno and Celgene shall reasonably cooperate with the other Party in its efforts to ensure that all government reporting, including price and gift reporting, sales, marketing and promotional practices in respect of each Celgene Program Co-Co Product for NA Territory Administration and ROW Territory Administration meet the standards required by Applicable Laws.

(b) Information . Each of Juno and Celgene shall reasonably cooperate with the other Party to provide the other Party access to any and all information, data and reports required by the other in order to enable the other Party to comply with applicable Laws, including reporting requirements, or the equivalent thereof anywhere the Parties are Developing or Commercializing Celgene Program Co-Co Products in the North America Territory and the ROW Territory, in a timely and appropriate manner. Each Party shall ensure that any such reporting is true, complete and correct in all respects; provided however that neither Party shall be held responsible for submitting erroneous reports to the extent such deficiencies result from information provided by the other Party which itself was not true, complete and correct.

(c) Cooperation . Juno and Celgene shall confer with each other on a regular basis through the JCC to discuss and compare their respective procedures and methodologies relating to each Party’s compliance with applicable Laws or fulfilment of any other obligation in this Section 2.3. In the event that the Parties have different understandings or interpretations of this Section 2.3 or of the applicability of, or standards required by any applicable Laws, then the Parties shall confer and seek to reach common agreement on such matters, and in the absence of such agreement, the escalation and decision making procedures set forth in Section 4.2.5 of the Master Collaboration Agreement shall apply.

(d) Antitrust Compliance . For the avoidance of doubt, the Parties shall continue to comply with Section 3.2 of the Master Collaboration Agreement.

2.4 Manufacturing and Supply. The provisions of Section 2.10 of the Master Collaboration Agreement and the Manufacturing Agreement shall apply to the Parties’ establishment and operation of manufacturing facilities for [***] Products and [***] Products in the Territory. The [***] pursuant to this Celgene Lead Co-Co Agreement shall be an Allowable Expense and shall be included in the Profit & Loss Share.

2.5 Records; Reports; Results. Each Party shall maintain or cause to be maintained complete, current and accurate records of all Development activities conducted by it (or its Affiliates and subcontractors) hereunder, and all data, results and analyses (including site records and master files) and other information resulting from such activities. Such records shall (i) fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes, and (ii) record only such activities and shall not include or be commingled with records of activities that

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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do not relate to the Development and Commercialization of Celgene Program Co-Co Products, Celgene Program Co-Co Candidates and/or Celgene Program Co-Co Diagnostic Products, or activities carried out pursuant to this Celgene Lead Co-Co Agreement. Each Party shall document all non-clinical studies and Clinical Trials in formal written study records according to applicable Laws, including national and international guidelines such as ICH, GCP, GLP and GMP. All such records shall be retained by the relevant Party for at least [***] after the termination of this Celgene Lead Co-Co Agreement or for such longer period as may be required by applicable Law. Each Party shall have the right, upon reasonable notice to the other Party to review and copy such records maintained by the other Party at reasonable times.

2.6 Materials Transfer; License.

2.6.1 Materials Transfer . During the Celgene Co-Co Term, either Party (the “ Celgene Co-Co Transferring Party ”) shall transfer, if [***] (the “ Celgene Co-Co Materials Receiving Party ”), certain [***] materials, which may include [***] (the “ Celgene Co-Co Materials ”) for use by the Celgene Co-Co Materials Receiving Party in furtherance of its rights and the conduct of its obligations under this Celgene Lead Co-Co Agreement (the “ Celgene Co-Co Purpose ”). All transfers of such Celgene Co-Co Materials by the Celgene Co-Co Transferring Party to the Celgene Co-Co Materials Receiving Party shall be documented in a material transfer agreement substantially in the form of Exhibit E , which sets forth the type and name of the Celgene Co-Co Material transferred, the amount of the Celgene Co-Co Material transferred, the date of the transfer of such Celgene Co-Co Material and the Celgene Co-Co Purpose (each, a “ Celgene Co-Co Material Transfer Agreement ”). Such Celgene Co-Co Materials will be provided to the requesting Party within a reasonable time period after the Parties execute the relevant Celgene Co-Co Material Transfer Agreement, not to exceed [***]. Neither Party will unreasonably withhold its consent to any request made by the other Party pursuant to this Section 2.6.1, except that Celgene shall have no obligation to transfer to Juno [***] unless it otherwise agrees in writing, [***] and Juno shall have no obligation to transfer to Celgene [***] unless it otherwise agrees in writing, [***]. The Parties agree that the exchanged Celgene Co-Co Materials shall be used in compliance with applicable Law and the terms and conditions of this Celgene Lead Co-Co Agreement, and shall not be reverse engineered or chemically analysed, except if required by the Celgene Co-Co Purpose or otherwise agreed to by the Parties in writing.

2.6.2 License by Celgene as Co-Co Transferring Party . At the time the Celgene Co-Co Transferring Party provides the Celgene Program Co-Co Materials to the Celgene Co-Co Materials Receiving Party as provided herein and to the extent not separately licensed under this Celgene Lead Co-Co Agreement, the Celgene Co-Co Transferring Party hereby grants and shall cause (within [***] after the execution of any Celgene Co-Co Material Transfer Agreement) its Affiliates to grant to the Celgene Co-Co Materials Receiving Party a non-exclusive license under the Patents and Know-How Controlled by it, to use such Celgene Co-Co Materials solely for the Celgene Co-Co Purpose, and such license, upon termination of this Celgene Lead Co-Co Agreement (subject to Article 9), completion of the Celgene Co-Co Purpose, or discontinuation of the use of such Celgene Co-Co Materials (whichever occurs first), shall automatically terminate. Except as otherwise provided under this Celgene Lead Co-Co

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Agreement, all such Celgene Co-Co Materials delivered by the Celgene Co-Co Transferring Party, shall only be used by the Celgene Co-Co Materials Receiving Party in furtherance of the Celgene Co-Co Purpose, and shall be returned to the Celgene Co-Co Transferring Party or destroyed, in the Co-Co Transferring Party’s sole discretion, upon the termination of this Celgene Lead Co-Co Agreement (subject to Article 9) or upon the discontinuation of the use of such Celgene Co-Co Materials (whichever occurs first), unless such Party has the right to continue to use such materials under the Master Collaboration Agreement, a Development & Commercialization Agreement for purposes permitted thereunder, including pursuant to material transfer agreements executed in connection therewith. The Celgene Co-Co Materials Receiving Party shall not [***].

2.6.3 NO WARRANTIES . THE CELGENE CO-CO MATERIALS SUPPLIED BY THE TRANSFERRING PARTY UNDER THIS SECTION 2.6 ARE SUPPLIED “AS IS” AND, EXCEPT AS OTHERWISE SET FORTH IN THIS CELGENE LEAD CO-CO AGREEMENT, THE TRANSFERRING PARTY MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE CO-CO MATERIALS OR USE THEREOF DO NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS OF A THIRD PARTY. The Celgene Co-Co Materials Receiving Party assumes all liability for damages that may arise from its use, storage or disposal of the Co-Co Materials. Except as otherwise set forth in this Celgene Lead Co-Co Agreement, the Celgene Co-Co Transferring Party shall not be liable to the Celgene Co-Co Materials Receiving Party for any loss, claim or demand made by the Celgene Co-Co Materials Receiving Party, or made against the Celgene Co-Co Materials Receiving Party by any Third Party, due to or arising from the use of the Celgene Co-Co Materials, except to the extent such loss, claim or demand is caused by the wilful misconduct of the Transferring Party.

2.7 No Representation. Subject to Section 2.2.2, neither Party makes any representation, warranty or guarantee that the Celgene Co-Co Program will be successful, or that any other particular results will be achieved with respect to the Celgene Co-Co Program, Celgene Program Co-Co Target, any Celgene Program Co-Co Candidate, any Celgene Program Co-Co Product or any Celgene Program Co-Co Diagnostic Product hereunder.

2.8 Covenant During Celgene Co-Co Term. Commencing on the Celgene Lead Co-Co Agreement Effective Date until expiration of each Party’s exclusivity obligations pursuant to Article 4 with respect to the Celgene Co-Co Program, neither Party nor its Affiliates will, other than to an Affiliate of such Party who agrees in writing to be bound by the terms and conditions of this Celgene Lead Co-Co Agreement, (a) assign, transfer, convey, encumber (including any liens or charges, but excluding any licenses, which are the subject of subsection (b), below) or dispose of, or enter into any agreement with any Third Party to assign, transfer, convey, encumber (including any liens or charges, but excluding any licenses, which are the subject to subsection (b), below) or dispose of, any assets [***] (the “ Celgene Co-Co Program Assets ”), except to the extent such assignment, transfer, conveyance, encumbrance or disposition would not conflict with or adversely affect in any respect any of the rights granted to the other

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Party hereunder, (b) license or grant to any Third Party, or agree to license or grant to any Third Party, any rights to any Celgene Co-Co Program Assets if such license or grant would conflict with or adversely affect in any respect any of the rights granted to the other Party hereunder, or (c) disclose any Confidential Information relating to the Celgene Co-Co Program Assets to any Third Party if such disclosure would impair or conflict in any respect with any of the rights granted to the other Party hereunder. Notwithstanding this Section 2.8, either Party and/or its Affiliates shall have the right to assign, transfer, convey or dispose of any assets specifically related to this Celgene Co-Co Program to [***]; provided that (i) [***] of this Celgene Lead Co-Co Agreement, and (ii) such [***] this Celgene Lead Co-Co Agreement.

ARTICLE 3

COMMERCIALIZATION; JUNO RIGHT TO OPT IN

3.1 Commercialization.

3.1.1 Commercialization Lead Party . Subject to the terms and conditions of this Celgene Lead Co-Co Agreement, including Juno’s rights under Sections 3.1.2 and 3.1.3, Celgene shall be the Commercialization Lead Party relating to all Celgene Program Co-Co Products for NA Territory Administration and ROW Territory Administration, and [***] with respect to all matters that relate to Commercialization of Celgene Program Co-Co Products throughout the North America Territory and the ROW Territory, after the matter [***]. Juno (itself or by or through any others, including any Affiliates or Sublicensees) will not take any action regarding the Commercialization of Celgene Program Co-Co Products in the Territory unless mutually agreed in writing following Juno’s election to participate in Commercialization Activities pursuant to Sections 3.1.2 or 3.1.3, or described in the Celgene Co-Co Commercialization Plan, or otherwise approved by the JCC.

3.1.2 Juno Co-Commercialization Right . Subject to Section 3.1.3, on a Celgene Program Co-Co Product-by-Celgene Program Co-Co Product basis, for any Celgene Co-Co Program under this Celgene Lead Co-Co Agreement that was:

(a) (i) a Celgene Program for which Juno exercised the Option pursuant to Section 3.1.3 of the Master Collaboration Agreement, or (ii) an [***] Program [***] for which Juno exercised its Option pursuant to Section 3.1.5 of the Master Collaboration Agreement, Juno shall have the right, [***], exercisable on written notice (the “ Juno Co-Commercialization Notice ”) delivered to Celgene at any time prior to, or within [***] following [***] such Celgene Program Co-Co Product, as applicable, in the North America Territory or [***] such Celgene Program Co-Co Product [***] the Major EU Market Countries, and (A) upon delivery of such Juno Co-Commercialization Notice, to elect to provide between [***] and [***] of the Commercialization Activities for such Celgene Program Co-Co Product for NA Territory Administration (including [***] in the North America Territory for such Celgene Program Co-Co Product), or (B) following exercise of the Commercialization Opt-In Right pursuant to Section 3.1.3, to elect to provide between [***] and [***] of the Commercialization activities for such Celgene Program Co-Co Product in the Major EU Market Countries (including [***] in the Major EU Market Countries for such Celgene Program Co-Co Product); or

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(b) (i) an [***] BD Program, for which Juno delivered an [***] Option Exercise Notice as set forth in Section 3.1.5 of the Master Collaboration Agreement, or (ii) a [***] BD Program for which Juno delivered a BD Option Exercise Notice as set forth in Section 2.2.1 of the Master Collaboration Agreement (and which did not become a [***] Program), then Juno shall have the right, [***], to deliver a Juno Co-Commercialization Notice to Celgene at any time prior to, or within [***] for a Celgene Program Co-Co Product, to elect to provide (A) between [***] and [***] of the Commercialization Activities for such Celgene Program Co-Co Product for NA Territory Administration (including [***] in the North America Territory for such Celgene Program Co-Co Product), and (B) between [***] and [***] of the Commercialization Activities for such Celgene Program Co-Co Product in the Major EU Market Countries (including [***] in the Major EU Market Countries for such Celgene Program Co-Co Product).

3.1.3 Juno [***] Opt-In Right for [***] Commercialization Activities . If:

(a) Juno has [***];

(b) Juno has [***]; or

(c) Juno or its Affiliates have [***],

then if the Celgene Co-Co Program under this Celgene Lead Co-Co Agreement was (i) a Celgene Program for which Juno exercised the Option pursuant to Section 3.1.3 of the Master Collaboration Agreement, or (ii) an [***] Program for which Juno exercised its Option pursuant to Section 3.1.5 of the Master Collaboration Agreement, then, on a Celgene Program Co-Co Product-by-Celgene Program Co-Co Product and territory-by-territory basis, Juno may exercise a Commercialization Opt-In Right upon written notice to Celgene at any time prior to, or within [***] in the Major EU Market Countries for a Celgene Program Co-Co Product, to elect to participate in a percentage of Commercialization Activities for such Celgene Program Co-Co Product for ROW Territory Administration in the Major EU Market Countries pursuant to Section 3.1.2(a)(B).

3.1.4 Scope of Commercialization Activities Post-Opt In . If Juno delivers a Juno Co-Commercialization Notice to Celgene pursuant to Section 3.1.2 (but subject to Section 3.1.3), [***], update the Celgene Co-Co Commercialization Plan for such countries to include the rights and obligations with respect thereto, which shall in any event be consistent with the then-existing Celgene Co-Co Commercialization Plan for the applicable countries prepared by [***] pursuant to Section 3.1.5, and which shall include the terms set forth in the Commercialization Opt-In Terms attached hereto as Exhibit F .

3.1.5 Celgene Co-Co Commercialization Plan .

(a) No later than [***] for the first Celgene Program Co-Co Product for NA Territory Administration or ROW Territory Administration (as set forth in the Celgene Co-Co Development Plan), Celgene will prepare an initial Commercialization plan for NA Territory Administration and for ROW Territory Administration covering the [***] after the First Celgene Program Co-Co Sale of such Celgene Program Co-Co Product in the relevant country(ies).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(b) The JCC will review and comment on the Celgene Co-Co Commercialization Plan. Thereafter, Celgene (in consultation with Juno) will update the relevant portion of the Celgene Co-Co Commercialization Plan (for the current [***]) annually, and the JCC will review and comment on any such update or other amendment to such Celgene Co-Co Commercialization Plan. Either Party may request at any time that the JCC consider other updates to such Celgene Co-Co Commercialization Plan. The JCC will set the required form and contents of any Celgene Co-Co Commercialization Plan. The Celgene Co-Co Commercialization Plan will specify, as applicable, among other things, for each applicable country and Celgene Program Co-Co Product, the principles established pursuant to Section 3.2.2 for global branding of Celgene Program Co-Co Products.

3.1.6 Commercialization Activities .

(a) Training . Celgene will (i) [***] with respect to Celgene Program Co-Co Products, and will [***] for such sales representatives therefor, and (ii) [***] for the Celgene Program Co-Co Product, [***]. [***] will [***] for the Celgene Program Co-Co Product anywhere in the Territory where Juno is co-Commercializing any Celgene Program Co-Co Product to [***] as and to the extent consistent with applicable Law. The Parties will cooperate, through the JCC, to determine and coordinate with respect to implementation of any training and conduct and content of detailing for Commercialization Activities for Celgene Program Co-Co Products that apply throughout the Territory.

(b) Sales Representatives; Detailing . For Celgene Program Co-Co Products in countries in which Juno provides Commercialization support to Celgene, each Party will be solely responsible for recruiting, hiring and maintaining its sales force of sales representatives for promotion of the Celgene Program Co-Co Product in the Territory, in accordance with (i) the share of such activities held by each Party in the applicable countries in the Territory pursuant to Sections 3.1.1 and 3.1.2 and (ii) its standard procedures and the requirements of this Celgene Lead Co-Co Agreement. Each Party shall engage sales representatives having the minimum qualifications set forth in Schedule 3.1.6(b) , provided that if Juno has exercised its right to co-Commercialize in the Major EU Market Countries pursuant to Sections 3.1.2 and/or 3.1.3, the sales representatives [***]. The Celgene Co-Co Commercialization Plan will set forth (A) [***], as applicable, consistent with the foregoing, (B) policies and processes for the [***], (D) the [***] sales representatives for Celgene Program Co-Co Products in each Calendar Year, (E) the allocation of [***] between the Parties, (F) development of [***], and (G) coordinating strategies for [***]. If [***] for the North America Territory or the Major EU Market Countries, then [***] will have the right to [***] until such time as [***], and, for clarity, all costs incurred by [***] related to [***]. Each Party will be responsible for the activities of such sales representatives, including compliance by such sales representatives with training and detailing requirements. In particular, each Party will provide its sales representatives assigned to promote the Celgene Program Co-Co Product in such countries with [***] with respect to the promotion of Celgene Program Co-Co Product necessary to [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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the Celgene Program Co-Co Product in accordance with the terms of this Celgene Lead Co-Co Agreement and applicable Law. Each Party agrees that none of its sales representatives involved in the promotion of the Celgene Program Co-Co Product will have any legal or regulatory disqualifications, bars or sanctions. If Celgene [***] regarding the [***] designated to be performed by Juno under this Article 3, [***] will [***] consistent with [***], which may include [***] the Celgene Program Co-Co Product. The calculation of costs of engaging such sales representatives for purposes of calculating Operating Profits or Losses shall be [***], and such [***].

(c) Promotional Materials . Juno’s sales representatives assigned to promote the Celgene Program Co-Co Product will utilize only promotional materials that have been approved by Celgene for the applicable territory. All detailing activities conducted by Juno’s sales representatives will be consistent in all material respects with the promotional materials so approved. Juno agrees that it will train and instruct its sales representatives to make only those statements and claims regarding the Celgene Program Co-Co Product, including as to efficacy and safety that are consistent with the Celgene Program Co-Co Product labelling and accompanying inserts and the approved promotional materials. For clarity, all marketing and promotional materials used by Juno and Juno’s sales representatives in Commercializing Celgene Program Co-Co Product under this Celgene Lead Co-Co Agreement must be approved by Celgene prior to use.

(d) Medical Affairs; Information . For Celgene Program Co-Co Products in countries in which Juno provides Commercialization support to Celgene, the Parties will discuss the execution of medical and scientific affairs and programs, including professional symposia and other educational activities, and medical affairs studies based upon approved protocols, including medical information support and medical communications and publishing activities, and the allocation of each Party to such activities in the Territory, provided that [***] to the conduct of such activities. The Parties acknowledge that in such countries each Party may receive requests for medical information concerning the Celgene Program Co-Co Product from members of the medical professions and consumers. [***] will have the [***] right to respond to questions and requests for information about Celgene Program Co-Co Product received from such Persons that [***] or that are [***] of the Celgene Program Co-Co Product [***] (each such request, an “ Information Request ”).

(e) Market Access Activities . [***], in consultation with the JCC, to develop plans for market access activities. For Celgene Program Co-Co Products in countries in which Juno provides Commercialization support to Celgene, each Party shall [***] in accordance with the Celgene Co-Co Commercialization Plan. For clarity, the costs related to such market access activities shall be [***].

(f) Reporting . Each Party will provide the JCC with a report, as soon as practicable but in no event later than [***] following the end of each Calendar Quarter commencing as of and after the first Celgene Program Co-Co Product has received Regulatory Approval in the Territory, or at such other time as the JCC deems appropriate, and for the

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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remainder of the Celgene Co-Co Term for such Celgene Program Co-Co Product, setting forth the number of details made by its sales representatives of Celgene Program Co-Co Products during such Calendar Quarter. Costs and expenses for sales representatives will be [***].

(g) Records . Each Party will maintain records and otherwise establish procedures to ensure compliance with all applicable Laws and professional requirements that apply to the promotion and marketing of Celgene Program Co-Co Product, including compliance with the PhRMA Code on Interactions with Healthcare Professionals.

3.1.7 Celgene Co-Co Commercialization Budget .

(a) At such times as the JCC will deem appropriate, and in no event later than concurrently with the preparation of the initial Celgene Co-Co Commercialization Plan, Celgene will prepare an initial budget for Commercialization Activities with respect to Celgene Program Co-Co Products for NA Territory Administration and for ROW Territory Administration. The JCC will review and approve such initial budgets for Commercialization in relation to Celgene Program Co-Co Products, and such budgets shall collectively constitute the “ Celgene Co-Co Commercialization Budget ”. Thereafter, Celgene will update the Celgene Co-Co Commercialization Budget at least once in each Calendar Year, (but in any event no later than [***] of each Calendar Year during the Celgene Co-Co Term) and the JCC will review and approve any such update or any other amendment to the Celgene Co-Co Commercialization Budget. In addition, either Party may request at any time that the JCC consider and approve other updates to the Celgene Co-Co Commercialization Budget.

(b) Subject to subsection (a), all [***] arising from either Party’s [***] (including any [***]) in accordance with the Celgene Co-Co Commercialization Plan and the Celgene Co-Co Commercialization Budget shall be [***].

3.2 Additional Terms. In addition:

3.2.1 Role of the JCC . The JCC will coordinate the Parties’ efforts with respect to the Commercialization of Celgene Program Co-Co Products in the Territory. Specifically, the JCC will oversee the development of global branding strategies for Celgene Program Co-Co Products, coordinate training of sales representatives and others involved in Commercialization pursuant to Sections 3.1.6 and Exhibit F , and coordinate commercial supply of Celgene Program Co-Co Products pursuant to this Celgene Lead Co-Co Agreement and the Manufacturing Agreement.

3.2.2 Branding . At such time as the JCC deems appropriate, the Parties shall discuss in good faith any branding and/or co-branding of the Celgene Program Co-Co Products, and the Parties will enter into appropriate trademark licensing agreements to achieve the foregoing. For the avoidance of doubt, nothing in this Celgene Lead Co-Co Agreement shall be construed to grant either Party any rights in or to any of the other Party’s trademarks, tradenames, logos, or other marks, including use thereof, absent a separate trademark licensing agreement entered into in accordance with this Section 3.2.2.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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3.2.3 Commercialization Reports. Each Party will provide the JCC with a report, as soon as practicable but in no event later than [***] following the [***] setting forth a [***] on the status of its Commercialization Activities with respect to Celgene Program Co-Co Products and Celgene Program Co-Co Diagnostic Products, including [***] of Celgene Program Co-Co Product in the Territory during [***] (a “ Celgene Co-Co Commercialization Report ”). At least [***] prior to the anticipated First Celgene Program Co-Co Sale of a Celgene Program Co-Co Product under this Celgene Lead Co-Co Agreement, the JCC shall discuss and agree upon the form and content for such Celgene Co-Co Commercialization Report. Such Celgene Co-Co Commercialization Report shall also describe [***] Celgene Program Co-Co Products and Celgene Program Co-Co Diagnostic Products, [***].

ARTICLE 4

EXCLUSIVITY

4.1 Exclusivity . Article 5 of the Master Collaboration Agreement shall apply to the Parties’ activities under this Celgene Lead Co-Co Agreement, in each case to the extent applicable to the Celgene Co-Co Program that is the subject of this Celgene Lead Co-Co Agreement, for the time periods, and to the extent expressly set forth therein.

ARTICLE 5

FINANCIAL TERMS

5.1 Option Exercise and Designation Payments . In partial consideration for the rights and licenses granted by Celgene pursuant to this Celgene Lead Co-Co Agreement, in connection with the execution of this Celgene Lead Co-Co Agreement:

5.1.1 Internally Developed Programs . If the Celgene Co-Co Program for which Juno exercises the Option is (a) [***], or (b) [***], then Juno shall pay to Celgene the amount set forth in Paragraph 1(a) or Paragraph 1(b), as applicable, of Exhibit C in accordance with the payment terms set forth therein.

5.1.2 BD Programs .

(a) If the Celgene Co-Co Program is an [***], then Juno shall pay to Celgene the amount set forth in Paragraph 1(c) of Exhibit C in accordance with the payment terms set forth therein; and

(b) If the Celgene Co-Co Program is a [***], then Juno shall pay to Celgene the amount set forth in Paragraph 1(e) of Exhibit C in accordance with the payment terms set forth therein.

5.2 Profit & Loss Share for Celgene Program Co-Co Product . The Parties will share in Operating Profits or Losses with respect to Celgene Program Co-Co Products in the Territory as follows:

5.2.1 [***] Program Share. Where the Celgene Program Co-Co Products

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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arose from (a) a Celgene Program for which Juno exercised the Option pursuant to Section 3.1.3 of the Master Collaboration Agreement, or (b) [***] for which Juno exercised its Option pursuant to Section 3.1.5 of the Master Collaboration Agreement (collectively “ Celgene Co-Co Internal Programs ”), Celgene will bear (and be entitled to) seventy percent (70%), and Juno will bear (and be entitled to) thirty percent (30%) of such Operating Profits or Losses with respect to Development and Commercialization of Celgene Program Co-Co Products in the Territory (each Party’s share of Operating Profits or Losses, the “ Celgene Internal Program Profit & Loss Share ”).

5.2.2 Celgene Co-Co BD Program Share . Subject to Section 5.2.3, if the Celgene Program Co-Co Products arose from (a) [***] for which Juno exercised its Option pursuant to Section 3.1.5 of the Master Collaboration Agreement, (b) [***] offered by Juno [***] and for which Celgene exercised its Option pursuant to Section 3.1.5 of the Master Collaboration Agreement, (c) [***] for which Juno exercised a BD Option pursuant to Section 2.2.1 of the Master Collaboration Agreement, or (d) [***] and for which Celgene exercised a BD Option pursuant to Section 2.2.1 of the Master Collaboration Agreement (collectively such Programs in (a) through (d) the “ Celgene Co-Co BD Programs ”), Celgene will bear (and be entitled to) [***], and Juno will bear (and be entitled to)[***] of such Operating Profits or Losses with respect to Development and Commercialization of Celgene Program Co-Co Products in the Territory (each Party’s share of such Operating Profits or Losses, the “ Celgene Co-Co BD Program Profit & Loss Share ”).

5.2.3 [***] Programs . Notwithstanding Section 5.2.2, solely with respect to a Celgene Co-Co BD Program that falls within [***], if, at the time Juno or Celgene, as applicable, [***] for such Celgene Co-Co BD Program, [***], then (a) for Celgene Program Co-Co Products [***] such Celgene Co-Co BD Program (the “[***]”), the Celgene Co-Co BD Program Profit & Loss Share shall apply, and (b) for Celgene Program Co-Co Products [***] other than the [***], the [***] shall apply.

5.2.4 Reporting . Procedures for reporting of actual results on a Calendar Quarter basis, review and discussion of potential discrepancies, reconciliation on a Calendar Quarter basis, reasonable forecasting, and other finance and accounting matters, are set forth in Exhibit D , and to the extent not set forth in Exhibit D , will be established by the JCC, subject to Section 5.4.3.

5.3 Discounted Sales . It is possible that a Celgene Program Co-Co Product could be included as part of a package of products offered to customers by either Party or its Affiliates or Sublicensees, and that discounts on packages including a Celgene Program Co-Co Product (a “ Package ”) may be offered in the Territory. Neither Celgene, its Affiliates nor Sublicensees shall discount the price of a Celgene Program Co-Co Product sold as part of a Package [***].

5.4 Additional Payment Terms .

5.4.1 Accounting . All payments hereunder shall be made in the United States in U.S. Dollars by wire transfer to a bank in the U.S. designated in writing by Celgene (with respect to payments under this Article 5), or the receiving Party. Conversion of sales recorded in local currencies to Dollars shall be performed in a manner consistent with [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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5.4.2 Late Payments . Any payments or portions thereof due hereunder that are not paid on the date such payments are due under this Celgene Lead Co-Co Agreement shall bear interest at an annual rate equal to the lesser of: (a) [***], or any successor thereto, at 12:01 a.m. on the first day of each Calendar Quarter in which such payments are overdue or (b) the maximum rate permitted by applicable Law; in each case calculated on the number of days such payment is delinquent, compounded monthly.

5.4.3 Tax Withholding .

(a) The Parties acknowledge that the rights and obligations imposed on each of them pursuant to this Celgene Lead Co-Co Agreement that [***] Rights (as defined in Exhibit H )] to the Celgene Program Co-Co Candidates, Celgene Program Co-Co Products and Celgene Program Co-Co Diagnostic Products and the [***] in connection therewith, [***], and the Parties shall act in accordance with Exhibit H . By execution of this Celgene Lead Co-Co Agreement, the Parties hereto intend that the [***], which shall be reflected in the [***] for each such region in accordance with Section 9.4.1(e)(i) of the Master Collaboration Agreement.

(b) Each Party shall be entitled to deduct and withhold from any amounts payable under this Celgene Lead Co-Co Agreement (or allocable to another Party pursuant to Section 1.6 of Exhibit H ) such taxes as are required to be deducted or withheld therefrom under any provision of applicable Law. The Party that is required to make such withholding (the “ Paying Party ”) will: (i) deduct those taxes from such payment, (ii) timely remit the taxes to the proper taxing authority, and (iii) send evidence of the obligation together with proof of tax payment to the recipient Party (the “ Payee Party ”) on a timely basis following that tax payment; provided, however, that before making any such deduction or withholding, the Paying Party shall give the Payee Party notice of the intention to make such deduction or withholding (such notice, which shall include the authority, basis and method of calculation for the proposed deduction or withholding, shall be given at least a reasonable period of time before such deduction or withholding is required, in order for such Payee Party to obtain reduction of or relief from such deduction or withholding); and provided, further, that in the event the relevant withholding tax is imposed with respect to an amount allocable pursuant to Section 1.6 of Exhibit H but the amount of any cash payment otherwise due to the Payee Party is either unavailable or insufficient for the Paying Party to be able to deduct the full amount of such withholding taxes, the Payee Party shall indemnify the Paying Party from and against such withholding taxes. Each Party agrees to cooperate with the other Parties in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect to ensure that any amounts required to be withheld pursuant to this Section 5.4.3(b) are reduced in amount to the fullest extent permitted by applicable Laws. In addition, the Parties shall cooperate in accordance with applicable Laws to [***]) in connection with this Celgene Lead Co-Co Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

29


(c) In the event that a liability is imposed by a taxing authority upon the Paying Party in respect of a failure to withhold on an amount payable under this Celgene Lead Co-Co Agreement, the Payee Party shall indemnify and hold harmless the Paying Parties from any and all liabilities, claims and losses with respect to such failure to withhold, provided that (1) the Paying Party shall notify the Payee Party promptly upon the receipt of any claim from a taxing authority which might give rise to an indemnification under this Section 5.4.3(c) (although the Paying Party’s delay in promptly notifying the Payee Party shall only reduce the Payee Party’s liability to indemnify the Paying Party to the extent that the Payee Party is prejudiced by such delay); (2) the Payee Party shall be entitled to participate, at its own expense, and with counsel of its choosing, in the defense of any claim which may give rise to liability under this Section 5.4.3(c); and (3) the Paying Party may not settle any liability with a taxing authority, to the extent such settlement would create a liability for the Payee Party under this Section 5.4.3(c), without the prior written consent of the Payee Party, which consent will not be unreasonably withheld, conditioned or delayed.

ARTICLE 6

INTELLECTUAL PROPERTY

6.1 License .

6.1.1 Licenses to Juno . Subject to the terms and on the conditions set forth in this Celgene Lead Co-Co Agreement, and solely with respect to the Celgene Program Co-Co Candidates, Celgene Program Co-Co Products and Celgene Program Co-Co Diagnostic Products that are the subject of this Celgene Lead Co-Co Agreement, Celgene hereby grants and shall cause (within [***] after the Celgene Lead Co-Co Agreement Effective Date) its Affiliates to grant to Juno: (a) a non-exclusive, royalty-free right and license, with the right to grant sublicenses [***] (subject to Section 6.1.3), under (i) the Celgene Program Co-Co IP, (ii) Celgene’s and its Affiliates’ rights in the Collaboration IP, and (iii) Celgene’s and its Affiliates’ interest in the Joint Collaboration IP, and (b) a non-exclusive, royalty-free right and license, with the right to grant sublicenses (subject to Section 6.1.3), under Patents and Know-How [***]; in each case of (a) and (b) [***] (1) for Research and Development activities with respect to Celgene Program Co-Co Candidates, Celgene Program Co-Co Products and Celgene Program Co-Co Diagnostic Products in the Field in the Territory [***] Juno in the applicable Celgene Co-Co Development Plan, (2) if Juno has delivered a Juno Co-Commercialization Notice pursuant to Section 3.1.2 or exercised its Commercialization Opt-In Right for the Major EU Market Countries pursuant to Section 3.1.3, to conduct Commercialization Activities that [***] Celgene Co-Co Commercialization Plan for [***], to Manufacture and/or have Manufactured Celgene Program Co-Co Candidates, Celgene Program Co-Co Products and/or Celgene Program Co-Co Diagnostic Products that are [***] Products. Celgene shall [***] upon written notice to Juno [***]; provided that (a) [***], (b) [***], and (c) [***].

6.1.2 License to Celgene . Subject to the terms and on the conditions set forth in this Celgene Lead Co-Co Agreement, and solely with respect to the Celgene Program Co-Co Candidates, Celgene Program Co-Co Products and Celgene Program Co-Co Diagnostic Products that are the subject of this Celgene Lead Co-Co Agreement, Juno hereby grants and shall cause

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(within [***] after the Celgene Lead Co-Co Agreement Effective Date) its Affiliates to grant to Celgene: (a) an exclusive ([***] to Research, Develop, Manufacture and Commercialize Celgene Program Co-Co Candidates, Celgene Program Co-Co Products and Celgene Program Co-Co Diagnostic Products [***]), royalty-free right and license, with the right to grant sublicenses through multiple tiers (subject to Section 6.1.3), under (i) the Juno Relevant Co-Co IP, (ii) Juno’s and its Affiliates’ rights in the Collaboration IP, and (iii) Juno’s and its Affiliates’ interest in the Joint Collaboration IP, and (b) a non-exclusive, royalty-free right and license, with the right to grant sublicenses (subject to Section 6.1.3), under Patents and Know-How [***]; in each case of (a) and (b) [***] to conduct Research, Development, Manufacture ([***]) and Commercialization Activities for Celgene Program Co-Co Candidates, Celgene Program Co-Co Products, and Celgene Program Co-Co Diagnostic Products in the Field in [***], that are [***] in the applicable Celgene Co-Co Development Plan and/or Celgene Co-Co Commercialization Plan. Juno shall [***] upon written notice to Celgene [***]; provided that (a) [***], (b) [***], and (c) [***].

6.1.3 Sublicenses .

(a) Celgene shall have the right to grant sublicenses within the scope of the license granted to Celgene under Section 6.1.2 as follows: (i) with respect to the right and license granted to Celgene under Section 6.1.2(a), through multiple tiers, [***], (ii) with respect to the right and license granted to Celgene under 6.1.2(b), [***], and (iii) otherwise [***].

(b) Juno shall have the right to grant sublicenses within the scope of the license granted to Juno under Section 6.1.1 as follows: (i) with respect to the right and license granted to Juno under Section 6.1.1(a), through multiple tiers, [***], (ii) with respect to the right and license granted to Juno under Section 6.1.1(b), [***], and (iii) otherwise [***].

(c) Each sublicense granted by either Party under this Section 6.1.3 shall be subject to and consistent with the terms and conditions of this Celgene Lead Co-Co Agreement. If a Party grants a sublicense under Section 6.1.3(a)(ii) or (iii) or under Section 6.1.3(b)(ii) or (iii), it shall [***].

6.1.4 Rights Retained by the Parties . For purposes of clarity, each Party retains the rights under Know-How and Patents Controlled by such Party not expressly granted to the other Party pursuant to this Celgene Lead Co-Co Agreement.

6.1.5 No Implied Licenses . Except as explicitly set forth in this Celgene Lead Co-Co Agreement, neither Party shall be deemed by estoppel or implication to have granted the other Party any license or other right to any intellectual property of such Party.

6.1.6 Section 365(n) of the Bankruptcy Code . All licenses granted under this Celgene Lead Co-Co Agreement are deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as defined in Section 91 of such Code. Each Party, as licensee, may fully exercise all of its rights and elections under the Bankruptcy Code. The Parties further agree that, if a Party elects to retain its rights as a licensee under any Bankruptcy Code, such Party shall be entitled to complete access to any technology licensed to it hereunder and all embodiments of such technology. Such embodiments of the technology shall be delivered to the licensee Party not later than: (a) the commencement of

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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bankruptcy proceedings against the licensor, upon written request, unless the licensor elects to perform its obligations under this Celgene Lead Co-Co Agreement, or (b) if not delivered under Section 6.1.6(a), upon the rejection of this Celgene Lead Co-Co Agreement by or on behalf of the licensor, upon written request. Any agreements supplemental hereto will be deemed to be “agreements supplementary to” this Celgene Lead Co-Co Agreement for purposes of Section 365(n) of the Bankruptcy Code.

6.2 Ownership .

6.2.1 Inventorship . Inventorship of Inventions shall be determined by application of U.S. patent law pertaining to inventorship.

6.2.2 Ownership . Ownership of Inventions and intellectual property rights therein arising from each of the Parties’ activities under this Celgene Lead Co-Co Agreement shall be determined in accordance with Sections 7.2.2, 7.2.3, 7.2.4 and 7.2.5 of the Master Collaboration Agreement.

6.2.3 Cooperation and Allocation . Sections 7.2.6, 7.2.7 and 7.2.8 of the Master Collaboration Agreement shall apply to all Inventions and intellectual property rights therein, that arise in whole or in part as a result of the Parties’ activities under this Celgene Lead Co-Co Agreement.

6.3 Prosecution and Maintenance of Patents . Subject to Section 6.7, Prosecution and Maintenance of all Patents directed to any Inventions [***] this Celgene Lead Co-Co Agreement shall be carried out in accordance with Section 7.3 of the Master Collaboration Agreement. Additionally, Celgene shall keep Juno informed as to [***] with respect to the Prosecution and Maintenance of Patents licensed to Juno under Section 6.1.1(a), and Juno shall keep Celgene informed as to [***] with respect to the Prosecution and Maintenance of Patents licensed to Celgene under Section 6.1.2(a). Celgene [***] with respect to any Patent Controlled by Celgene licensed to Juno under Section 6.1.1(a), and Juno shall [***] with respect to any Patent Controlled by Juno licensed to Celgene under Section 6.1.2(a).

6.4 Defense of Claims Brought by Third Parties .

6.4.1 Notice . If a Party becomes aware of any actual or potential claim alleging that the Research, Development, Manufacture or Commercialization of the Celgene Program Co-Co Target, any Celgene Program Co-Co Candidate, any Celgene Program Co-Co Product or any Celgene Program Co-Co Diagnostic Product, does (or would if carried out) infringe the intellectual property rights of any Third Party anywhere in the North America Territory or the ROW Territory, such Party shall [***]. In any such instance, the Parties shall [***].

6.4.2 Costs . The costs and expenses incurred by the Parties in connection with defense of any claim described in Section 6.4.1 shall be [***], unless otherwise agreed in writing by the Parties.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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6.5 Enforcement of Patents .

6.5.1 Notice . If any Party learns of an infringement or suspected or threatened infringement by a Third Party with respect to any Patent licensed to Celgene pursuant to Section 6.1.2 or any Patent licensed to Juno pursuant to Section 6.1.1, including actual or alleged infringement under 35 USC §271(e)(2) that is or would be infringing activity involving the using, making, importing, offering for sale or selling of compounds or products that are substantially the same as Celgene Program Co-Co Candidates, Celgene Program Co-Co Products or Celgene Program Co-Co Diagnostic Products (“ Celgene Program Co-Co Competitive Infringement ”), such Party shall [***] such Celgene Program Co-Co Competitive Infringement. For any Celgene Program Co-Co Competitive Infringement, each Party shall [***].

6.5.2 Scope of Enforcement Rights . As between the Parties, and subject to Sections 6.7 and 6.8:

(a) Notwithstanding anything to the contrary herein, with respect to any Celgene Program Co-Co Competitive Infringement in the [***], Celgene shall have the [***] to enforce any Patent Controlled by Celgene or its Affiliates that (a) is within the [***] Celgene Program Co-Co Candidates, Celgene Program Co-Co Products or Celgene Program Co-Co Diagnostic Products, (b) is within the [***] Celgene Program Co-Co Candidates, Celgene Program Co-Co Products or Celgene Program Co-Co Diagnostic Products.

(b) Celgene shall have the [***] right, [***], to institute, prosecute, and control any action or proceeding with respect to any Celgene Program Co-Co Competitive Infringement occurring in the [***] of any Patents that [***], and are included in (i) [***], and/or (ii) [***], the “ Celgene Program Co-Co Product Patent(s) ”);

(c) With respect to any Patent Controlled by [***] or its Affiliates that (i) [***] one or more Celgene Program Co-Co Candidates, Celgene Program Co-Co Products, or Celgene Program Co-Co Diagnostic Products and is included in (A) the [***] (excluding [***]) and that [***], or (B) the [***], or (ii) that [***]) one or more Celgene Program Co-Co Candidates, Celgene Program Co-Co Products, or Celgene Program Co-Co Diagnostic Products, and is included in [***] and that also [***], then in each of (i) and (ii), if [***] wishes to institute, prosecute, and control any action or proceeding with respect to any Celgene Program Co-Co Competitive Infringement occurring in Territory, it shall so notify [***], prior to [***] to institute, prosecute or control such Celgene Program Co-Co Competitive Infringement, [***] whether or not [***] should have the right to bring such action or proceeding. [***] shall institute, prosecute or control any such action or proceeding with respect to any Celgene Program Co-Co Competitive Infringement of the Patents described in this Section 6.5.2(c) unless [***].

(d) [***] shall not have the right, to institute, prosecute, or control any action or proceeding with respect to any Celgene Program Co-Co Competitive Infringement in the [***] of any Patent Controlled by [***] (or its Affiliates that is (i) within the [***], and/or (ii) within the [***] and which [***], and that [***]. [***] may request in writing that [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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consent to [***] institution, prosecution or control of any such action or proceeding with respect to any such Patent described in this Section 6.5.2(d)(i)—(iii). If [***] receives any such request, the Parties [***] regarding whether or not [***] will agree to grant [***] the right to institute, prosecute or control such action or proceeding, provided that [***] may [***].

(e) Unless otherwise agreed by the parties, and subject to Sections 6.5.1(a) and 6.5.3, any rights granted to Celgene to institute, prosecute, and control any action or proceeding with respect to any Celgene Program Co-Co Competitive Infringement under Sections 6.5.2(b)—(d) are, in each case, by counsel of Celgene’s own choice, in Celgene’s own name and under Celgene’s direction and control, provided that with respect to any such action or proceeding in relation to Celgene Program Co-Co Candidates, Celgene Program Co-Co Products or Celgene Program Co-Co Diagnostic Products, Celgene shall [***], in such action, and shall [***]. The foregoing right of Celgene shall include, if applicable, the right to perform, with respect to such actions with respect to Celgene Program Co-Co Competitive Infringement in [***] actions of a reference product sponsor or equivalent set forth in the Hatch-Waxman Act or Public Health Service Act, (or any ex-U.S. equivalent of the either of the foregoing), and if Celgene is limited in performing such actions, Juno shall reasonably cooperate to enable Celgene to perform such actions.

6.5.3 Timing . Celgene, with respect to action or proceeding for any Celgene Program Co-Co Competitive Infringement of any Celgene Program Co-Co Product Patent (each action or proceeding, a “ Celgene Program Co-Co Enforcement Proceeding ”), will have a period of [***] after its receipt or delivery of notice and evidence pursuant to Section 6.5.1 or receipt of written notice from a Third Party that reasonably evidences Celgene Program Co-Co Competitive Infringement, to elect to so enforce such Celgene Program Co-Co Product Patent in the applicable jurisdiction (or to settle or otherwise secure the abatement of such Celgene Program Co-Co Competitive Infringement), provided however, that such period will be (a) more than [***] to the extent applicable Law prevents earlier enforcement of such Celgene Program Co-Co Product Patent (such as the enforcement process set forth in or under the Hatch-Waxman Act or Public Health Service Act, or any ex-U.S. equivalent of the either of the foregoing)), and provided further that if such period is extended because applicable Law prevents earlier enforcement, the enforcing Party shall have until the date that is [***] following the date upon which applicable Law first permits such Celgene Program Co-Co Enforcement Proceeding, and (b) less than [***] to the extent that a delay in bringing such Celgene Program Co-Co Enforcement Proceeding against such alleged Third Party infringer would limit or compromise the remedies (including monetary relief, and stay of regulatory approval) available against such alleged Third Party infringer. In the event Celgene [***] before the first to occur of (i) the expiration of the applicable period of time set forth in the preceding subsections (a) and (b), or (ii) [***] before the expiration of any time period under applicable Law, that would, if a Celgene Program Co-Co Enforcement Proceeding was not filed within such time period, limit or compromise the remedies available from such Celgene Program Co-Co Enforcement Proceeding, it will [***] and in the case where Juno then [***] the applicable Celgene Program Co-Co Product Patent with respect to such Celgene Program Co-Co Competitive Infringement in the applicable jurisdiction, Juno will thereafter have[***] to enforce the applicable Celgene Program Co-Co Product Patent (such action, a “ Celgene Program Co-Co Step-In Proceeding ”) at Juno’s expense.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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6.5.4 Sole Enforcement and Defense for [***] . Notwithstanding anything to the contrary herein, with respect to any Celgene Program Co-Co Competitive Infringement:

 

  (a) [***]; and

 

  (b) [***].

6.5.5 Right to Participate; Joinder . The non-enforcing Party in relation to any enforcement action or proceeding set forth in Section 6.5.2 will have the right, by counsel of its choice, to be represented in, or participate in any such action or proceeding. In the case of any Celgene Program Co-Co Enforcement Proceeding or Celgene Program Co-Co Step-In Proceeding, at the enforcing Party’s written request, (subject to Section 6.5.8), the other Party will join any such action or proceeding as a party and will use Commercially Reasonable Efforts to cause any Third Party as necessary to join such action or proceeding as a party if doing so is necessary for the purposes of establishing standing or is otherwise required by applicable Law to pursue such action or proceeding. All time periods set forth in Section 6.5.3 shall be subject to applicable Law, which may prevent earlier enforcement.

6.5.6 Cooperation . In addition to the obligations set forth in Sections 6.5.2 and 6.5.4, each other Party will provide to the Party enforcing any such rights under Sections 6.5.2 reasonable assistance and cooperation in such enforcement, at such enforcing Party’s request and expense. The enforcing Party will keep the other Party regularly informed of the status and progress of such enforcement efforts. The Parties will coordinate any Celgene Program Co-Co Enforcement Proceeding through the Patent Committee. Each Party bringing any action or proceeding in accordance with this Section 6.5 shall have an obligation to consult with the other Party and will take comments of such other Party into good faith consideration with respect to the infringement, claim construction, or defense of the validity or enforceability of any claim in any Patent that is the subject of such proceeding, provided that the foregoing shall not apply to any such action or proceeding as it relates to [***]. Only with respect to any Patent within the [***] that [***] Celgene Program Co-Co Product [***], Celgene Program Co-Co Candidate [***] Celgene Program Co-Co Diagnostic Product [***], the Parties shall [***].

6.5.7 Third Party Rights . Notwithstanding Sections 6.5.2 through 6.5.5, Each Party’s rights to enforce a Patent pursuant to this Section 6.5, or to Defend against a challenge in any action or proceeding described in Section 6.4, shall be subject to the applicable provisions of any agreements between such Party and its licensor(s) of such Patent, if any. In the event of any conflict between this Section 6.5 and such other agreements between a Party (and/or its Affiliates) and its/their licensor(s), the provisions of such other agreements shall control.

6.5.8 Inter Partes Review and Re-Examination Proceedings . If either Party becomes aware of any actual or potential inter partes review, re-examination or post grant review proceedings (but excluding [***], such Party shall so notify the other Party. The Party having

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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the right to bring an enforcement action pursuant to this Section 6.5 with respect to such Patent shall have the right to assume responsibility for the Defense thereof, with the other Party having backup rights therefor to the extent provided to such Party in the context of an action to enforce such Patent, with the costs of such action [***]. If neither Party has a right to bring an enforcement action pursuant to this Section 6.5 with respect to such Patent, then the Party Controlling such Patent shall have the right to assume responsibility for the Defense thereof.

6.5.9 Settlement . A settlement or consent judgment or other voluntary final disposition of a suit or proceeding under this Section 6.5 may be [***]; provided, however, that any such settlement, consent judgment or other disposition of any action or proceeding by the Party under this Section 6.5 shall not, without the consent of such other Party, (a) [***] the Party not bringing or Defending such action or proceeding, (b) include the [***] the Party not bringing or Defending such action or proceeding [***], (c) [***] the Party not bringing or Defending such action or proceeding, or (d) [***] such Party not bringing or Defending such action or proceeding [***].

6.5.10 Costs and Recoveries . Except as otherwise set forth in this Section 6.5, each Party shall [***] in connection with its activities under this Section 6.5. If a Party commences a Celgene Program Co-Co Enforcement Proceeding or any other action or proceeding with respect to any Celgene Program Co-Co Competitive Infringement occurring in the Territory or Defends an action described in Section 6.4, it shall [***] for such action or proceeding. All [***] incurred by either Party in pursuing any Celgene Program Co-Co Enforcement Proceeding in accordance with this Section 6.5 shall be [***]. Any damages or other monetary awards recovered in any action, suit or proceeding brought under this Section 6.5 shall be shared as follows:

(a) The amount of such damages or other sums actually received by the Party controlling such action shall first be subject to Article 7, and then shall be applied to reimburse all out-of-pocket costs and expenses incurred by each Party directly in connection with such action (including, for this purpose, [***]), and if such recovery is insufficient to cover all such costs and expenses of both Parties, it shall be [***]; and

(b) any remaining proceeds in case of suits with respect to a Celgene Program Co-Co Enforcement Proceeding any other action or proceeding with respect to any Celgene Program Co-Co Competitive Infringement occurring in the Territory relating to any Celgene Program Co-Co Product, Celgene Program Co-Co Candidate or Celgene Program Co-Co Diagnostic Product under this Section 6.5 shall be [***].

6.6 Patent Term Extensions . If, during the Celgene Co-Co Term, either Party wishes to apply for or obtain any patent term extensions, restorations, or supplementary protection certificates (in each case based on delays or activities associated with seeking Regulatory Approval) under applicable Laws (such extensions, restorations and certificates, collectively, “ Patent Term Extension ”) for a Patent [***] (“ Celgene Program Co-Co Covering Patent ”), in the North America Territory or the ROW Territory, the following shall apply:

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(a) Subject to Sections 6.6(b) and (c), if such Celgene Program Co-Co Covering Patent is a [***], Section 7.6 of the Master Collaboration Agreement shall apply to determine whether such Patent Term Extension shall be sought or obtained, provided that if the Parties are unable to reach mutual agreement regarding whether to seek or obtain such Patent Term Extension, (i) if [***], then notwithstanding anything to the contrary in Section 7.6 of the Master Collaboration Agreement, [***] shall have the right to make the final decision as to whether such Patent Term Extension shall be sought or obtained; and (ii) otherwise, notwithstanding anything to the contrary in Section 7.6 of the Master Collaboration Agreement, [***] seek or obtain a Patent Term Extension for such Celgene Program Co-Co Covering Patent [***].

(b) Notwithstanding anything to the contrary herein or in the Master Collaboration Agreement, for any Celgene Program Co-Co Covering Patent that is [***], [***] Patent Term Extension shall be sought or obtained by [***].

(c) Notwithstanding anything to the contrary herein or in the Master Collaboration Agreement, Juno shall have no right to seek or obtain Patent Term Extension, [***], for any Patent Covering or claiming [***]; and [***] Patent Term Extension, [***], for any Patent Covering or [***].

6.7 [***] . Notwithstanding anything to the contrary in Sections 6.3 through 6.6, or in the Master Collaboration Agreement, (a) [***] and (b) [***].

6.8 [***] Patents . Section 7.8 of the Master Collaboration Agreement shall apply.

6.9 Regulatory Data Protection . To the extent required or permitted by applicable Law, Celgene will use Commercially Reasonable Efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities in a given country during the Celgene Co-Co Term, all applicable Patents for any Celgene Program Co-Co Product that Celgene [***], Commercialize, such listings to include all so called “Orange Book” listings required under the U.S. Hatch-Waxman Act or the equivalent thereof outside of the U.S., if applicable. Prior to such listings, the Parties [***] applicable Patents. Notwithstanding the preceding sentence, Celgene will [***] as to the listing of all applicable Patents for such Celgene Program Co-Co Product, regardless of [***] such Patent.

6.10 Third Party Licenses . If, at any time during the Celgene Co-Co Term, a Party [***] that any Third Party intellectual property rights [***] the Development, Manufacture or Commercialization of any Celgene Program Co-Co Product or Celgene Program Co-Co Candidate, that is the subject of Research, Development, Manufacture and/or Commercialization efforts under this Celgene Lead Co-Co Agreement, then such Party [***], and Section 7.9 of the Master Collaboration Agreement shall apply. Any amounts due pursuant to any agreement entered into pursuant to Section 7.9 of the Master Collaboration Agreement [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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ARTICLE 7

UPSTREAM AGREEMENTS

7.1 Upstream Obligations . Each Party acknowledges and agrees that all licenses granted under this Celgene Lead Co-Co Agreement, to the extent they constitute sublicenses under intellectual property rights owned by a Third Party and licensed or sublicensed to a Party under a Juno Upstream Agreement or a Celgene Upstream Agreement, as applicable, and licensed to the other Party pursuant to this Celgene Lead Co-Co Agreement are subject to the relevant terms and conditions of the Celgene Upstream Agreements and/or the Juno Upstream Agreements, as applicable. Any exclusive licenses that are granted under this Celgene Lead Co-Co Agreement that constitute sublicenses under the Celgene Upstream Agreements or the Juno Upstream Agreements, as applicable, are exclusive only to the extent of the exclusive nature of the license granted to Celgene or Juno, as applicable, under the Celgene Upstream Agreements or the Juno Upstream Agreements, as applicable.

ARTICLE 8

INDEMNIFICATION; INSURANCE

8.1 Indemnification by Juno . Juno shall indemnify, defend and hold harmless the Celgene Indemnitees, from and against any and all Damages to the extent arising out of or relating to, directly or indirectly, any Claim based upon:

(a) the [***] under this Celgene Lead Co-Co Agreement; or

(b) any [***] this Celgene Lead Co-Co Agreement;

provided however that in each case, such indemnity [***].

8.2 Indemnification by Celgene . Celgene shall indemnify, defend and hold harmless the Juno Indemnitees, from and against any and all Damages to the extent arising out of or relating to, directly or indirectly, any Claim based upon:

(a) the [***] under this Celgene Lead Co-Co Agreement;

(b) any [***] this Celgene Lead Co-Co Agreement;

(c) any [***], in each case, resulting from any of the foregoing activities described in this Section 8.2(c);

provided however that in each case, such indemnity [***].

8.3 Notice of Claims . A Claim to which indemnification applies under Section 8.1 or Section 8.2 shall be referred to herein as an “Indemnification Claim.” If the Indemnitee intends to claim indemnification under this Article 8, the Party claiming indemnification (the “ Indemnitee ”) shall notify the indemnifying Party (the “ Indemnitor ”) in writing, promptly upon becoming aware of an Indemnification Claim, describing in reasonable detail the facts

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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giving rise to the Indemnification Claim; provided, that an Indemnification Claim in respect of any action at law or suit in equity by or against a Third Party as to which indemnification shall be sought shall be given promptly after the action or suit is commenced (provided that the Indemnitee is aware of such commencement); and provided further, that the failure by an Indemnitee to give such notice shall not relieve the Indemnitor of its indemnification obligation under this Celgene Lead Co-Co Agreement except and only to the extent that the Indemnitor is actually prejudiced as a result of such failure to give notice.

8.4 Indemnification Procedures . If an Indemnitee receives written notice of a Claim that the Indemnitee believes may result in a claim for indemnification under this Article 8, such Indemnitee shall deliver an Indemnification Claim to the Indemnitor in accordance with the provisions of Section 8.3. If the [***], then the Indemnitor shall have the right to assume and control the defense of the Claim, at its own expense with counsel selected by it and reasonably acceptable to the Indemnitee, by delivering written notice of its assumption of such defense to the Indemnitee within [***] of its receipt of notice of such Claim from the Indemnitor (but the Indemnitor shall in any event have the right to assume and control the defense of a Claim that [***], whichever is first); provided, however, that the Indemnitee shall have the right to retain its own counsel, with the reasonable fees and expenses to be paid by the Indemnitor, if (a) representation of the Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential conflict of interests between such Indemnitee and Indemnitor, (b) the Indemnitor has failed within a reasonable time to retain counsel, (c) the Indemnitee shall have reasonably concluded that there may be legal defenses available to it that are different from or in addition to those available to the Indemnitor, or (d)[***]. If the Indemnitor assumes and controls the defense of such Claim, the Indemnitor shall keep the Indemnitee reasonably apprised of the status of the Claim and the Indemnitee shall be entitled to otherwise monitor such Claim at its sole cost and expense. If the Claim [***] against or from the Indemnitee or if the Indemnitor does not assume the defense of the Claim as described in this Section 8.4, the Indemnitee shall be permitted to assume and control the defense of such Claim (but shall have no obligation to do so) and in such event shall be entitled to settle or compromise the Indemnification Claims in its sole and reasonable discretion, provided that if the Indemnitee is entitled to assume the defense of the Claim pursuant to this Section 8.4 solely because the Claim [***] against or from the Indemnitee, then the Indemnitee shall not settle or compromise such Indemnification Claims in any manner that involves [***] without the prior written consent of the Indemnitor, which consent the Indemnitor shall not unreasonably withhold, condition or delay. If the Indemnitor has assumed and controls the defense of the Claim in accordance with this Section 8.4, (i) the Indemnitee shall not settle or compromise the Indemnification Claim without the prior written consent of the Indemnitor, such consent not to be unreasonably withheld, conditioned or delayed and (ii) the Indemnitor shall not settle or compromise the Indemnification Claim in any manner that would result in the payment of amounts by the Indemnitee, impose any other obligation on the Indemnitee or otherwise have an adverse effect on the Indemnitee’s rights or interests (including any rights under this Celgene Lead Co-Co Agreement or the Equity Purchase Agreement or the scope or enforceability of any Patents or Know-How licensed by one Party to another Party pursuant to this Celgene Lead Co-Co Agreement or any other Development & Commercialization Agreement, or the Master

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Collaboration Agreement), without the prior written consent of the Indemnitee. In each case, the Party that is not controlling the defense of any Claim shall reasonably cooperate with the Party that is controlling the defense of such Claim, at the non-controlling Party’s expense and shall make available to the controlling Party all pertinent information under the control of the non-controlling Party, which information shall be subject to Article 8 of the Master Collaboration Agreement. Each Party shall use commercially reasonable efforts to avoid production of Confidential Information of the other Party (consistent with applicable Law and rules of procedure), and to cause all communications among employees, counsel and other representatives of such Party to be made so as to preserve any applicable attorney-client or work-product privileges.

8.5 Celgene Co-Co Program Administration Liabilities . In the event that either Party (a) incurs any [***] relating thereto, or (b) is required to [***] (collectively “ Celgene Program Co-Commercialization Territory Administration ” of such Celgene Program Co-Co Product, and such liabilities in (a) and (b) the “ Celgene Program Co-Commercialization Territory Administration Liabilities ”), such Celgene Program Co-Commercialization Territory Administration Liabilities arising from or occurring as a result of the performance, [***], of the Development, Manufacture or Commercialization of Celgene Program Co-Co Product for Celgene Program Co-Commercialization Territory Administration in accordance with this Celgene Lead Co-Co Agreement will be [***] will not include Co-Commercialization Territory Administration Liabilities of a Party or its Affiliates: (i) that are caused by [***]; (ii) incurred with respect to or allocable to [***]; or (iii) that are subject to [***], respectively, that would otherwise be [***], then Celgene Program Co-Commercialization Territory Administration Liabilities incurred by Celgene or Juno in connection with [***] will [***]

8.6 LIMITATION OF LIABILITY . EXCEPT (A) FOR A BREACH OF [***] OR (B) FOR CLAIMS THAT ARE SUBJECT TO INDEMNIFICATION UNDER THIS ARTICLE 8 OR (C) FOR DAMAGES DUE TO THE [***] OF THE LIABLE PARTY, NEITHER CELGENE NOR JUNO, NOR ANY OF THEIR RESPECTIVE AFFILIATES WILL BE LIABLE TO THE OTHER PARTY TO THIS CELGENE LEAD CO-CO AGREEMENT OR ITS AFFILIATES FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE OR EXEMPLARY DAMAGES OR LOST PROFITS OR LOST DATA, WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY), INDEMNITY OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE.

ARTICLE 9

CELGENE CO-CO TERM AND TERMINATION

9.1 Celgene Co-Co Term; Expiration .

9.1.1 This Celgene Lead Co-Co Agreement shall become effective on the Celgene Lead Co-Co Agreement Effective Date and, unless earlier terminated pursuant to this

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Article 9, shall remain in effect until the Parties [***] Develop and Commercialize all Celgene Program Co-Co Development Candidates, Celgene Program Co-Co Products and Celgene Program Co-Co Diagnostic Products (the “ Celgene Co-Co Term ”).

9.2 Termination Without Cause . At any time during the Celgene Co-Co Term, Juno shall have the right, at its sole discretion, to terminate this Celgene Lead Co-Co Agreement in its entirety, upon [***] prior written notice to Celgene hereunder; it being understood and agreed that Juno shall be entitled to terminate upon [***] written notice at any time it reasonably determines that such termination is necessary to comply with any Antitrust Law.

9.3 Termination for Breach .

9.3.1 Termination by Either Party for Breach .

(a) Subject to certain variations set forth in Section 9.3.2 with respect to a material breach by either Party of its obligation to use Commercially Reasonable Efforts pursuant to Section 2.2.2, this Celgene Lead Co-Co Agreement and the rights granted herein may be terminated by either Party for the material breach by the other Party of this Celgene Lead Co-Co Agreement, [***], provided, that the breaching Party has not cured such breach within [***] ([***], in the case of the breaching Party’s payment obligations under this Celgene Lead Co-Co Agreement, or the time period provided in Section 9.3.2 with respect to a material breach by a Party of its obligation to use Commercially Reasonable Efforts) (the “ Cure Period ”) after the date of written notice to the breaching Party of such breach, which notice shall describe such breach in reasonable detail and shall state the non-breaching Party’s intention to terminate this Celgene Lead Co-Co Agreement pursuant to this Section 9.3.1. Notwithstanding the preceding sentence, the Cure Period for any allegation made in good faith as to a material breach under this Celgene Lead Co-Co Agreement will run from the [***]; and

(b) Any termination of this Celgene Lead Co-Co Agreement under this Section 9.3.1 shall become effective at the end of the Cure Period, unless the breaching Party has cured any such breach or default prior to the expiration of such Cure Period, or, if such breach is not susceptible to cure within the Cure Period, then, the non-breaching Party’s right of termination shall be [***]. The Parties understand and agree that [***] for purposes of determining [***].

9.3.2 Additional Procedures for Termination by a Party for Failure of the other Party to Use Commercially Reasonable Efforts . If either Party wishes to exercise its right to terminate this Celgene Lead Co-Co Agreement pursuant to Section 9.3.1 for the other Party’s material breach of its obligations to use Commercially Reasonable Efforts as set forth in Section 2.2.2, it shall provide to such other Party a written notice of its intent to exercise such right, which notice shall be labelled as a “notice of material breach for failure to use Commercially Reasonable Efforts,” and shall state the reasons and justification for such termination and [***]. For any such notice of breach given by a Party, the Cure Period shall be [***], and shall become effective in accordance with Section 9.3.1.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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9.3.3 Disagreement as to Material Breach . If the Parties reasonably and in good faith disagree as to whether there has been a material breach pursuant to Section 9.3.1, the Party that disputes that there has been a material breach may contest the allegation by referring such matter, within [***] following such notice of alleged material breach for resolution to the Executive Officers, who shall meet promptly to discuss the matter, and determine, within [***] following referral of such matter, whether or not a material breach has occurred pursuant to Section 9.2. If the Executive Officers are unable to resolve a dispute within such [***] period after it is referred to them, the matter will be resolved as provided in Section 12.7 of the Master Collaboration Agreement.

9.4 Termination for Patent Challenges.

9.4.1 Termination by Celgene for Patent Challenge . Celgene shall have the right to terminate this Celgene Lead Co-Co Agreement upon written notice if Juno or any of its Affiliates (as defined in Section 1.2(a) of the Master Collaboration Agreement) challenges the validity, scope or enforceability, or otherwise opposes any Patent included in the [***] that is licensed to Juno under this Celgene Lead Co-Co Agreement (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order); it being understood and agreed that Celgene’s right to terminate this Celgene Lead Co-Co Agreement under this Section 9.4 shall not apply to any Affiliate of Juno (as defined in Section 1.2(a) of the Master Collaboration Agreement) that first becomes such an Affiliate as a result of or after the effective date of a Business Combination involving Juno, where such new Affiliate was undertaking any of the activities described in the foregoing clause prior to such Business Combination; provided that Celgene’s right to terminate this Celgene Lead Co-Co Agreement under this Section 9.4 shall apply to such new Affiliate if Juno is the acquiror in such Business Combination and such new Affiliate does not terminate or otherwise cease such challenge or opposition within [***] after the effective date of such Business Combination. If a Sublicensee of Juno challenges the validity, scope or enforceability of or otherwise opposes any Patent included in [***] under which such Sublicensee is sublicensed, then Juno shall, [***] from Celgene, terminate such sublicense. For the avoidance of doubt, an action by Juno or any Affiliate (as defined in Section 1.2(a) of the Master Collaboration Agreement) in accordance with Article 7 of the Master Collaboration Agreement to amend claims within a pending patent application of Celgene during the course of Juno’s Prosecution and Maintenance of such pending patent application or in defense of a Third Party proceeding, or to make a negative determination of patentability of claims of a patent application of Celgene or to abandon a patent application of Celgene during the course of Juno’s Prosecution and Maintenance of such pending patent application, shall not constitute a challenge under this Section 9.4.

9.4.2 Termination by Juno for Patent Challenge . Juno shall have the right to terminate this Celgene Lead Co-Co Agreement upon written notice if Celgene or any of its Affiliates (as defined in Section 1.2(a) of the Master Collaboration Agreement) challenges the validity, scope or enforceability, or otherwise opposes any Patent included in the [***] that is licensed to Celgene under this Celgene Lead Co-Co Agreement (other than as may be necessary

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

42


or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order); it being understood and agreed that Juno’s right to terminate this Celgene Lead Co-Co Agreement under this Section 9.4 shall not apply to any Affiliate of Celgene (as defined in Section 1.2(a) of the Master Collaboration Agreement) that first becomes such an Affiliate as a result of or after the effective date of a Business Combination involving Celgene, where such new Affiliate was undertaking any of the activities described in the foregoing clause prior to such Business Combination; provided that Juno’s right to terminate this Celgene Lead Co-Co Agreement under this Section 9.4 shall apply to such new Affiliate if Celgene is the acquiror in such Business Combination and such new Affiliate does not terminate or otherwise cease such challenge or opposition within [***] after the effective date of such Business Combination. If a Sublicensee of Celgene challenges the validity, scope or enforceability of or otherwise opposes any Patent included in the [***] under which such Sublicensee is sublicensed, then Celgene shall, [***] from Juno, terminate such sublicense. For the avoidance of doubt, an action by Celgene or any of its Affiliates (as defined in Section 1.2(a) of the Master Collaboration Agreement) in accordance with Article 7 of the Master Collaboration Agreement to amend claims within a pending patent application of Juno during the course of Celgene’s Prosecution and Maintenance of such pending patent application or in defense of a Third Party proceeding, or to make a negative determination of patentability of claims of a patent application of Juno or to abandon a patent application of Juno during the course of Celgene’s Prosecution and Maintenance of such pending patent application, shall not constitute a challenge under this Section 9.4.

9.5 Termination for Bankruptcy. If either Party makes a general assignment for the benefit of creditors, appoints or suffers appointment of a receiver or trustee over all or substantially all of its property, files a petition under any bankruptcy or insolvency act or has any such petition filed against it which is not dismissed, discharged, bonded or stayed within ninety (90) days after the filing thereof, the other Party may terminate this Celgene Lead Co-Co Agreement in its entirety, effective immediately upon written notice to such Party. In connection therewith, the provisions of Section 6.1.6 shall apply.

9.6 Termination for Breach of Standstill. Juno may terminate this Celgene Lead Co-Co Agreement immediately upon written notice to Celgene, in the event that Juno exercises its right to terminate this Celgene Lead Co-Co Agreement under Section 2.2 of the Voting and Standstill Agreement resulting in the termination of the Voting and Standstill Agreement (as defined in the Master Collaboration Agreement).

9.7 Effects of Expiration or Termination.

9.7.1 Termination by Juno Pursuant to Section 9.2, or by Celgene Pursuant to Section 9.3, 9.4, or 9.5 . In the event this Celgene Lead Co-Co Agreement is terminated by Juno pursuant to Section 9.2 or by Celgene pursuant to Section 9.3, 9.4, or 9.5, then notwithstanding anything contained in this Celgene Lead Co-Co Agreement to the contrary, upon the effective date of such termination:

(a) Celgene Co-Co Termination . All licenses granted to Juno under this Celgene Lead Co-Co Agreement shall terminate in their entirety, Juno shall cease any and all

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

43


Development, and Commercialization Activities with respect to all terminated Celgene Program Co-Co Products, Celgene Program Co-Co Candidates and Celgene Program Co-Co Diagnostic Product, and all rights in such terminated Celgene Program Co-Co Products, Celgene Program Co-Co Candidates and Celgene Program Co-Co Diagnostic Products granted by Celgene to Juno shall revert to Celgene pursuant to Section 9.8;

(b) Return of Confidential Information . Each Party shall return or destroy all Confidential Information of the other Party pursuant to Article 8 of the Master Collaboration Agreement, unless such information is practiced by the receiving Party pursuant to licenses retained after any such termination under this Celgene Lead Co-Co Agreement, another Development & Commercialization Agreement or the Master Collaboration Agreement; and

(c) Survival of License . The license granted to Celgene in Section 6.1.2 shall automatically convert to the applicable license set forth in Section 9.8.

9.7.2 Termination by Juno Pursuant to Section 9.3, 9.4, 9.5 or 9.6 . In the event this Celgene Lead Co-Co Agreement is terminated by Juno pursuant to Section 9.3, 9.4, 9.5, or 9.6, then (a) subject to Section 9.10, all rights and obligations of the Parties under this Celgene Lead Co-Co Agreement shall terminate, except that Section 9.8.1 shall apply following the effective date of such termination, and (b) each Party shall return or destroy any Confidential Information of the other Party pursuant to Article 8 of the Master Collaboration Agreement that is not necessary to practice any licenses and other rights retained by such Party following such termination under this Celgene Lead Co-Co Agreement, another Development & Commercialization Agreement or the Master Collaboration Agreement.

9.8 Celgene Program Co-Co Reversion Products.

9.8.1 Reversion . If this Celgene Lead Co-Co Agreement terminates for any reason, then all Celgene Program Co-Co Products, Celgene Program Co-Co Diagnostic Products and/or Celgene Program Co-Co Candidates shall be deemed “ Celgene Program Co-Co Reversion Products ”. Subject to the remainder of this Section 9.8.1, Juno shall grant and hereby grants to Celgene a non-exclusive, royalty-free, non-assignable (except as provided in Section 10.4) license, with the right to grant sublicenses [***], under (a) [***], (b) [***], and (c) [***], in each case of (a) through (c), [***] Research, Develop, Manufacture, use, import, offer for sale, sell, and Commercialize Celgene Program Co-Co Reversion Products in the Territory in the Field, [***] the Celgene Program Co-Co Reversion Products [***].

9.8.2 Effects of Reversion . With respect to each Celgene Program Co-Co Product, Celgene Program Co-Co Candidate or Celgene Program Co-Co Diagnostic Product that becomes a Celgene Program Co-Co Reversion Product:

(a) Juno shall return to Celgene [***], at no cost to Celgene, all Know-How within the Celgene Program Co-Co IP transferred by Celgene to Juno with respect to each such Celgene Program Co-Co Reversion Product;

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

44


(b) Except to the extent not permitted pursuant to any agreements between Juno and a Third Party, Juno shall provide to Celgene, [***], at Celgene’s request, subject to Celgene’s [***] pertaining to the applicable Celgene Program Co-Co Reversion Products [***] such Celgene Program Co-Co Reversion Products, including copies of (i) [***] Celgene Program Co-Co Reversion Products, if applicable and (ii) materials and documents relating to [***] such Celgene Program Co-Co Reversion Products by Juno or its Affiliates [***]. For clarity, Celgene shall have the right to use the foregoing [***] information, materials and data [***] of Celgene Program Co-Co Reversion Products;

(c) with respect to any Celgene Program Co-Co Product, Celgene Program Co-Co Candidate or Celgene Program Co-Co Diagnostic Product that becomes an Celgene Program Co-Co Reversion Product as a result of termination of this Celgene Lead Co-Co Agreement at a time during which Juno is conducting a Clinical Trial for such Celgene Program Co-Co Product, Celgene Program Co-Co Candidate or Celgene Program Co-Co Diagnostic Product, Juno will, as directed by Celgene, [***], if such termination is pursuant to Sections 9.3, 9.4, or 9.5 (in each case by Celgene), and otherwise [***];

(d) Juno shall otherwise cooperate reasonably with Celgene to provide a transfer of the materials described in Sections 9.8.2(a) through (c), such transfer to be completed within [***] after the Parties have identified the Know-How to be transferred;

(e) As and to the extent a Third Party is manufacturing such Celgene Program Co-Co Reversion Product for supply to Celgene by Juno, Juno shall [***], to assist in [***]. If, at any time during the Celgene Co-Co Term, Juno or an Affiliate of Juno begins manufacturing any Celgene Program Co-Co Product, Celgene Program Co-Co Candidate or Celgene Program Co-Co Diagnostic Product, the Parties shall [***] of such Celgene Program Co-Co Product, Celgene Program Co-Co Candidate or Celgene Program Co-Co Diagnostic Product from Juno or such Affiliate to Celgene or Celgene’s designee in the event such Celgene Program Co-Co Candidate or Celgene Program Co-Co Product becomes a Celgene Program Co-Co Reversion Product, which shall include [***]. Additionally, upon any Celgene Program Co-Co Product, Celgene Program Co-Co Candidate or Celgene Program Co-Co Diagnostic Product becoming a Celgene Program Co-Co Reversion Product, at Celgene’s request, Juno shall [***], for a price equal to [***];

(f) To the extent that Juno owns any trademark(s) and/or domain names that [***] a Celgene Program Co-Co Reversion Product that [***] for the Commercialization of a Celgene Program Co-Co Reversion Product (as [***], but not including any marks that include, in whole or part, any corporate name or logo of Juno), Celgene shall have the right to [***]. Celgene shall exercise such right by written notice to Juno within [***] after such Celgene Program Co-Co Candidate or Celgene Program Co-Co Product or Celgene Program Co-Co Diagnostic Product becomes a Celgene Program Co-Co Reversion Product. The Parties shall [***] to Celgene for up to [***] after Juno receives any such written notice from Celgene; and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

45


(g) If Juno has obtained a Third Party License with respect to such Celgene Program Co-Co Reversion Product and Celgene is a sublicensee under such Third Party License, then [***] such Third Party License to the extent due with respect to the [***].

9.9 Survival of Sublicenses. Celgene’s right to grant sublicenses under the licenses granted in Section 9.8 shall survive any termination of this Celgene Lead Co-Co Agreement. With the exception of the foregoing, termination of this Celgene Lead Co-Co Agreement shall be construed as a termination of any sublicense granted by either Party to any Sublicensee hereunder, provided however that such Sublicensee shall have the right to request that such Party grants to such Sublicensee a direct license, and such Party [***].

9.10 Surviving Provisions.

9.10.1 Accrued Rights; Remedies . Termination, relinquishment or expiration of this Celgene Lead Co-Co Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of any Party prior to such termination, relinquishment or expiration, including the payment obligations under Article 5 hereof, and any and all damages or remedies (whether in law or in equity) arising from any breach hereunder. Such termination, relinquishment or expiration shall not relieve any Party from obligations which are expressly indicated to survive termination of this Celgene Lead Co-Co Agreement. Except as otherwise expressly set forth in this Celgene Lead Co-Co Agreement, the termination provisions of this Article 9 are in addition to any other relief and remedies available to either Party under this Celgene Lead Co-Co Agreement and at applicable Law.

9.10.2 Survival . Notwithstanding any provision herein to the contrary, any rights or obligations otherwise accrued hereunder (including any accrued payment obligations) shall survive the expiration or termination of this Celgene Lead Co-Co Agreement. Further, the rights and obligations of the Parties set forth in the following Sections and Articles and Exhibits shall survive the expiration or termination of this Celgene Lead Co-Co Agreement, in addition to those other terms and conditions that are expressly stated to survive termination or expiration of this Celgene Lead Co-Co Agreement: Sections (a) 2.3.2(b), 2.3.6(b), 2.5 (as to activities conducted during the Celgene Co-Co Term and activities conducted thereafter to the extent applicable to Celgene’s retained rights and licenses pursuant to Section 9.8), 2.6.1 (as to Celgene Program Co-Co Materials transferred during the Celgene Co-Co Term), 2.6.2 (to the extent that the Celgene Co-Co Materials Receiving Party retains a license to use such Celgene Co-Co Materials following termination), 2.6.3 (as to Celgene Co-Co Materials transferred during the Celgene Co-Co Term), 2.7, 5.4.3 (as to activities conducted during the Celgene Co-Co Term), 6.1.3 (to the extent applicable), 6.1.4, 6.1.5, 6.1.6, 6.2, 6.5 (to the extent Celgene retains rights and licenses [***], and except that Section 6.5.10 shall apply only if [***]), 6.7, 6.8, 6.9 (last sentence, to the extent a party retains rights or license after termination), Article 7 (to the extent applicable to claims arising [***] exercise of its rights and licenses pursuant to Section 9.8), Article 8 (to the extent applicable to claims arising [***] of provisions that are deemed to survive pursuant to this Celgene Lead Co-Co Agreement or to the extent a Party [***] from the other Party to Develop, Manufacture or Commercialize Celgene Program Co-Co Candidates, Celgene Program Co-Co Products or Celgene Program Co-Co Diagnostic Products after such

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

46


termination), Sections 9.7, 9.8, 9.9, 9.10, 9.11, Article 10 and Exhibit A, Exhibit B, Exhibit D (to the extent applicable to activities conducted [***]) and Exhibit H (to the extent applicable to activities conducted [***]); provided that such survival shall be limited to any specific time periods set forth in such Articles and Sections.

9.11 Relationship to Other Agreements. Termination of this Celgene Lead Co-Co Agreement shall not affect in any way the terms or provisions of the Master Collaboration Agreement, any other then-existing executed Development & Commercialization Agreement or the Equity Purchase Agreement.

ARTICLE 10

MISCELLANEOUS

10.1 Confidentiality; Publicity.

10.1.1 Confidentiality . The confidentiality, non-disclosure and non-use obligations set forth in Article 8 of the Master Collaboration Agreement, including each Party’s rights and obligations with respect to publicity and publications set forth in Sections 8.6 and 8.7.2 of the Master Collaboration Agreement, shall apply to the Parties’ performance of all activities under this Celgene Lead Co-Co Agreement.

10.1.2 Press Release . Upon or following the Celgene Lead Co-Co Agreement Effective Date, the Parties may issue the form of press release agreed by the Parties pursuant to Section 8.6 of the Master Collaboration Agreement and attached hereto as Exhibit D . In all other cases, the issuance of any press release or other public statement by either Party or their respective Affiliates disclosing any information relating to this Celgene Lead Co-Co Agreement, the activities hereunder, or the transactions contemplated hereby shall be subject to Section 8.6 of the Master Collaboration Agreement.

10.2 Disclaimer of Warranties. Except as otherwise expressly set forth in this Celgene Lead Co-Co Agreement or the Master Collaboration Agreement, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY THAT ANY PATENTS ARE VALID OR ENFORCEABLE, AND EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. Without limiting the generality of the foregoing, each Party disclaims any warranties with regards to: (a) the success of any study or test, including the Celgene Co-Co Program, commenced under this Celgene Lead Co-Co Agreement; (b) the safety or usefulness for any purpose of the technology or materials, including any Celgene Program Co-Co Candidate, Celgene Program Co-Co Product or a Celgene Program Co-Co Diagnostic Product, it provides or discovers under this Celgene Lead Co-Co Agreement; or (c) the validity, enforceability, or non-infringement of any intellectual property rights or technology it provides or licenses to the other Party under this Celgene Lead Co-Co Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

47


10.3 Applicability of Terms of Master Collaboration Agreement. In addition to those provisions of the Master Collaboration Agreement that are expressly stated in this Celgene Lead Co-Co Agreement to apply to the Parties activities hereunder, Sections 12.1, 12.2, 12.3, 12.5, 12.6, 12.7, 12.8, 12.9 (with respect to the Parties ability to bind one another and with respect to third party beneficiaries), 12.11, 12.12, 12.13, 12.14 and 12.15 of the Master Collaboration Agreement shall apply in full to the Party’s performance of all activities under this Celgene Lead Co-Co Agreement. References to “Agreement” in such sections shall refer to this Celgene Lead Co-Co Agreement.

10.4 Assignment.

10.4.1 Generally . This Celgene Lead Co-Co Agreement may not be assigned by any Party, nor may any Party delegate its obligations or otherwise transfer licenses or other rights created by this Celgene Lead Co-Co Agreement, except as expressly permitted hereunder without the prior written consent of the other Party, which consent will not be unreasonably withheld, delayed or conditioned.

10.4.2 Celgene . Notwithstanding the limitations in Section 10.4.1, Celgene Corp. and Celgene RIVOT may assign this Celgene Lead Co-Co Agreement, or any rights or obligations hereunder in whole or in part, to (a) one or more Affiliates solely as provided in this Section 10.4.2 or (b) its successor in interest in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Celgene Lead Co-Co Agreement; provided however that, except in the case where Celgene Corp., or Celgene RIVOT, as applicable, is [***], (i) Celgene Corp. or Celgene RIVOT, as applicable, provides Juno with at least [***] advance written notice of any such assignment(s), (ii) prior to such assignment(s), Celgene Corp. or Celgene RIVOT, as applicable, agrees in a written agreement delivered to Juno (and upon which Juno may rely) to remain fully liable for the performance of its obligations under this Celgene Lead Co-Co Agreement by its assignee(s), and (iii) prior to such assignment(s), the assignee(s) agree in a written agreement delivered to Juno (and upon which Juno may rely) to assume performance of all such assigned obligations. If Celgene Corp. or Celgene RIVOT, as applicable, wishes to assign [***], it will be permitted to do so conditioned on such [***], pursuant to which such [***].

10.4.3 Juno . Notwithstanding the limitations in Section 10.4.1, Juno may assign this Celgene Lead Co-Co Agreement, or any rights or obligations hereunder in whole or in part, to (a) one or more Affiliates solely as provided in this Section 10.4.3 or (b) its successor in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Celgene Lead Co-Co Agreement; provided however that, except in the case where Juno [***], (i) Juno provides Celgene with at least [***] advance written notice of any such assignment(s), (ii) prior to such assignment(s), Juno agrees in a written agreement delivered to Celgene (and upon which Celgene may rely) to remain fully liable for the performance of its obligations under this Celgene Lead Co-Co Agreement by its assignee(s), (iii) prior to such assignment(s), the assignee(s) agree in a written agreement delivered to Celgene (and upon which Celgene may rely) to assume performance of all such assigned obligations, (iv) in the case of any assignment(s) by Juno, all [***], and (v) all

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

48


of the matters referred to in clauses (i), (ii), (iii) and (iv), as applicable, will be set forth in documentation [***] prior to any such assignment(s) [***] and in all cases will provide [***]. If Juno wishes to assign [***], it will be permitted to do so conditioned on [***], pursuant to which such [***].

10.4.4 All Other Assignments Null and Void . The terms of this Celgene Lead Co-Co Agreement will be binding upon and will inure to the benefit of the successors, heirs, administrators and permitted assigns of the Parties. Any purported assignment in violation of this Section 10.4 will be null and void ab initio.

10.4.5 Business Combinations . Notwithstanding anything to the contrary in this Celgene Lead Co-Co Agreement, with respect to any intellectual property rights controlled by the acquiring party or its Affiliates (if other than one of the Parties to this Celgene Lead Co-Co Agreement) involved in any Business Combination of either Party, such intellectual property rights shall not be included in the technology and intellectual property rights licensed to the other Party hereunder to the extent held by such acquirer or its Affiliate (other than the relevant Party to this Celgene Lead Co-Co Agreement) prior to such transaction, or to the extent such technology is developed outside the scope of activities conducted with respect to the Collaboration, Celgene Co-Co Program, Celgene Program Co-Co Candidates, Celgene Program Co-Co Products or related Celgene Program Co-Co Diagnostic Products. The Celgene Program Co-Co IP and [***] shall exclude any intellectual property [***] by a permitted assignee or successor and not developed in connection with the Collaboration, Celgene Co-Co Program, Celgene Program Co-Co Candidates, or Celgene Program Co-Co Products, or related Celgene Program Co-Co Diagnostic Products, researched, Developed or Commercialized pursuant to this Celgene Lead Co-Co Agreement, any other Development & Commercialization Agreement or the Master Collaboration Agreement.

10.5 Entire Agreement. This Celgene Lead Co-Co Agreement, together with the attached Exhibits and Schedules, and the Master Collaboration Agreement, including its Exhibits and Schedules, contains the entire agreement by the Parties with respect to the subject matter hereof and supersedes any prior express or implied agreements, understandings and representations, either oral or written, which may have related to the subject matter hereof in any way, and any and all term sheets relating to the transactions contemplated by this Celgene Lead Co-Co Agreement and exchanged between the Parties prior to the Celgene Lead Co-Co Agreement Effective Date.

[Signature Page Follows]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

49


IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have caused this Celgene Lead Co-Co Agreement to be executed by their respective duly authorized officers as of the Celgene Lead Co-Co Agreement Effective Date.

 

JUNO THERAPEUTICS, INC.       CELGENE CORPORATION
By:  

 

      By:  

 

Name:  

 

      Name:  

 

Title:  

 

      Title:  

 

 

        CELGENE RIVOT LTD.
        By:  

 

        Name:  

 

         Title:  

 

[Signature page to Celgene Lead Co-Co Agreement]


EXHIBIT A

Celgene Co-Co Program

The Program that is the subject of this Celgene Lead Co-Co Agreement (the “ Celgene Co-Co Program ”) is:

¨ the [                      ] Program,

which is a

¨ a Celgene Program;

¨ an [***] Program;

¨ a [***] BD Program;

¨ an [***] BD Program for which [***] is the Offering Party;

¨ an [***] BD Program for which the Lead Development Candidate is a [***] and for which [***] is the Offering Party;

¨ a [***] BD Program where the Lead Development Candidate is a [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

A - 1


EXHIBIT B

Celgene Program Co-Co Target, Celgene [***] and Celgene Program Co-Co Candidates

For the Celgene Co-Co Program that is:

¨ the [                      ] Program, then:

 

  A. the “ Celgene Program Co-Co Target ” is: [                      ]; and

 

  B. the “[***]” are: [                      ]; and

 

  C. the “ Celgene Program Co-Co Candidates ” are: each [***] Agent that is [***] to the [***] for [ insert applicable Target ], and that is designed, discovered, generated, invented or conceived by Celgene or any of its Affiliates [***]. For clarity, and as set forth in Section 1.24 of the Master Collaboration Agreement, Celgene Program Co-Co Candidates also include [***].

¨ For clarity, for each of the foregoing Celgene Co-Co Programs, in no event shall any Target listed on Schedule 1.25 of the Master Collaboration Agreement be a Celgene Program Co-Co Target.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

B - 1


EXHIBIT C

Co-Co Upfront Payments

In consideration for the rights and licenses granted to Juno under this Celgene Lead Co-Co Agreement with respect to the Celgene Co-Co Program:

1. Option Exercise and Designation Payments .

(a) If the Parties have entered into this Celgene Lead Co-Co Agreement as a result of Juno’s delivery of an Option Exercise Notice for a Celgene Co-Co Program that was (i) a Celgene Program for which Juno exercised the Option pursuant to Section 3.1.3 of the Master Collaboration Agreement, or (ii) [***] for which Juno exercised its Option pursuant to Section 3.1.5 of the Master Collaboration Agreement, and [***] the Designation Payment as calculated and payable in accordance with Sections 6.4.2 of the Master Collaboration Agreement [***], then Juno shall, within [***] following the delivery of such Juno Option Exercise Notice, pay to Celgene such Designation Payment for such [***] Program, as applicable;

(b) If the Parties have entered into this Celgene Lead Co-Co Agreement as a result of Juno’s delivery of an Option Exercise Notice for a Celgene Co-Co Program that was (i) a Celgene Program for which Juno exercised the Option pursuant to Section 3.1.3 of the Master Collaboration Agreement, or (ii) [***] for which Juno exercised its Option pursuant to Section 3.1.5 of the Master Collaboration Agreement, and [***] the Designation Payment as calculated and payable pursuant to Section 6.4.2 of the Master Collaboration Agreement, [***], then Juno shall [***].

(c) Subject to subsection (d) below, if the Parties have entered into this Celgene Lead Co-Co Agreement with respect to an [***], Juno shall, within [***] after delivery to Celgene of the [***] Option Exercise Notice for such [***] Program, pay to Celgene the [***], as set forth in Section 6.5.3 of the Master Collaboration Agreement, [***] Portion in accordance with Section 6.5.3 of the Master Collaboration Agreement.

(d) Notwithstanding subsection (c), if (i) such [***] Option Exercise Notice was delivered [***].

(e) Subject to subsection (f) below, if the Parties have entered into this Celgene Lead Co-Co Agreement as a result of Juno’s delivery of a BD Option Exercise Notice for a [***] Program pursuant to Section 2.2.1 of the Master Collaboration Agreement, and Juno delivered such BD Option Exercise Notice for such [***] Program to Celgene within the BD Evaluation Period, Juno shall, within [***] after delivery to Celgene of the BD Option Exercise Notice for such [***] Program, pay to Celgene the BD Opt-In Payment as a lump sum payment equal to [***] BD Program [***], provided that if [***] BD Program [***], then for the purposes of [***] in accordance with Section 2.2.1(c) of the Master Collaboration Agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

C - 1


(f) Notwithstanding subsection (e), if (i) such [***] Option Exercise Notice was delivered [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

C - 2


EXHIBIT D

Profit & Loss Share

This Exhibit D to this Celgene Lead Co-Co Agreement covers financial planning, accounting policies and procedures to be followed in determining the Profit & Loss Share. The Profit & Loss Share is not a legal entity and has been defined for identification purposes only.

1. Principles of Reporting.

(a) The presentation of results of operation of the Parties with respect to Celgene Program Co-Co Products in the Territory will be based on each Party’s respective financial information presented separately and on a consolidated basis in the reporting format depicted as follows with respect to all countries within the Territory, for calculating Profit & Loss Share for Celgene Program Co-Co Products in the Territory:

 

     Celgene    Juno

Total

         

[***]

     

[***]

     

[***]

     

[***]

     

[***]

     

[***]

     

(b) It is the intention of the Parties to interpret definitions to be consistent with this Exhibit D and Accounting Principles, it being understood and agreed that (i) “Operating Profits or Losses” shall be calculated in accordance with [***]. Where such costs will be determined based on [***], each Party agrees to provide reasonable supporting documentation, as may be requested by the other Party, to ensure that each Party’s methodologies are reasonable and consistently applied. To the extent that such costs are not readily determinable [***], the JCC will develop a reasonable methodology for determining such costs. Reasonable methodologies may include a standard rate or some other appropriate basis for allocating costs.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

D - 1


(c) If necessary, a Party will make the appropriate adjustments to the financial information it supplies under this Exhibit D to conform to the above format of reporting results of operation.

(d) The Parties agree that all Celgene Co-Co Net Sales of Celgene Program Co-Co Product in the Territory will be booked by Celgene.

2. Frequency of Reporting .

(a) The fiscal year for the purposes of reporting and other activities undertaken by the Parties pursuant to this Exhibit D will be a Calendar Year. Unless the schedule of such reporting is altered by the JSC, reporting by each Party for revenues and expenses will be as set forth in this Paragraph 2 of this Exhibit D .

(b) Celgene will prepare, for sales of Celgene Program Co-Co Product, a consolidated reporting of the activities undertaken by the Parties hereunder (including Operating Profit or Loss), the calculation of the Operating Profit or Loss sharing, and determination of the cash settlement as between the Parties. Celgene will provide Juno within [***] after the end of each Calendar Quarter, a detailed statement showing the consolidated results and calculations of the Operating Profit or Loss sharing and cash settlement required in a format agreed to by the Parties (the “ Report ”). Juno will cooperate as appropriate and provide Celgene with financial statements, within [***] of the end of each Calendar Quarter, for Juno’s activities with respect to Celgene Program Co-Co Product, prepared in accordance with the terms contained in the financial planning, accounting and reporting procedures set forth in this Exhibit D in order for Celgene to prepare the consolidated reports, including in reasonable detail the following costs and expenses incurred by Juno in such Calendar Quarter: [***].

(c) On a [***] basis, Celgene will supply Juno with an estimate of Celgene Co-Co Net Sales during the prior month of such Celgene Program Co-Co Product in the Territory , [***] (using the conversion method set forth in this Celgene Lead Co-Co Agreement) according to Celgene’s sales reporting system, which will be [***]. Celgene shall also provide to Juno information regarding [***]. Each such report will be provided [***] after the last day of the [***] in question, and will separately provide monthly and year-to-date cumulative figures. Celgene will provide to Juno, [***], an updated report for the [***].

3. Financial Records . With respect to all financial records and reports required by this Exhibit D , each Party to the extent applicable hereunder will keep financial records in accordance with its Accounting Principles. All cost reporting will be based on the appropriate costs definitions stated in Paragraph 7 of this Exhibit D or elsewhere in this Celgene Lead Co-Co Agreement, and each Party will report costs in a manner consistent with a mutually agreed standard.

4. Operating Profits and Loss Sharing .

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

D - 2


(a) The Parties agree to share Operating Profits and Losses with respect to Development and Commercialization of Celgene Program Co-Co Products in the Territory as set forth below:

(i) If Section 5.2.1 of this Celgene Lead Co-Co Agreement applies, then for Celgene Program Co-Co Products arising from such [***] Programs Celgene will bear (and be entitled to) [***], and Juno will bear (and be entitled to) [***] of Operating Profits or Losses;

(ii) If Section 5.2.2 of this Celgene Lead Co-Co Agreement applies, then for Celgene Program Co-Co Products arising from such [***] Programs, Celgene will bear (and be entitled to) [***], and Juno will bear (and be entitled to) [***] of Operating Profits and Losses; and

(iii) If Section 5.2.3 of this Celgene Lead Co-Co Agreement applies, then for Celgene Program Co-Co Products containing [***], for the relevant [***] Program, Celgene will bear (and be entitled to) [***], and Juno will bear (and be entitled to) [***] of Operating Profits or Losses.

(b) Celgene shall either invoice Juno, or pay to Juno, at the time the Report is delivered to Juno, an amount such that Juno will be bearing its Profit & Loss Share (as defined in Section 6.2 of this Celgene Lead Co-Co Agreement) for the relevant sales of Celgene Program Co-Co Product. Either (i) Juno shall make payment in full to Celgene of the amount of any such invoice, within [***] after the date of such invoice, or (ii) Celgene shall pay Juno within [***] after the Report is delivered to Juno, an amount such that Juno will bear or receive its Profit & Loss Share. Such amounts will be invoiced and paid (whether before or after Regulatory Approval is received) pursuant to this Paragraph 4(b) of this Exhibit D . All payments to be made by either Party hereunder will be made in U.S. Dollars by wire transfer to such bank account as such Party may designate.

(c) In the event any payment is made after the date specified in Paragraph 4(b) of this Exhibit D and provided that such payment is not otherwise subject to good faith dispute, the paying Party will pay the additional amounts or the receiving Party will reimburse such excess payments, with interest from the date originally due as provided in Section 6.4.2 of this Celgene Lead Co-Co Agreement.

5. Start of Operations and Effective Accounting Date Termination .

(a) Operation of the Profit & Loss Share will be [***]. Except as otherwise provided herein, costs and expenses incurred prior to such date are [***].

(b) Unless otherwise set forth in this Celgene Lead Co-Co Agreement, for reporting and accounting purposes with respect to the Profit & Loss Share, the effective termination date of the Celgene Lead Co-Co Agreement with regard to the last detailing year for Celgene Program Co-Co Product will be the end of the month in which such termination takes place.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

D - 3


6. Audits . Each Party will keep, and will cause its Affiliates and Sublicensees, as applicable, to keep, accurate books and records of accounting as required under its Accounting Principles for the purpose of calculating all amounts payable by either Party to the other Party under the Profit & Loss Share, including with respect to the calculation of Allowable Expenses, Gross Profit and Celgene Co-Co Net Sales of Celgene Program Co-Co Product for NA Territory Administration and ROW Territory Administration. Such records shall be retained by each Party or any of its Affiliates or Sublicensees (in such capacity, the “ Recording Party ”) for a period of no less than [***] after the [***] to which such records relate. At the request of either Party, the other Party will, and, will cause its Affiliates and Sublicensees, as applicable, to, permit the requesting Party and its representatives (including an independent auditor), at reasonable times and upon reasonable notice to the Recording Party, to inspect, review and audit the books and records maintained pursuant to this Paragraph 6 of this Exhibit D . Such examinations may not, unless otherwise required by applicable Law, (a) be conducted for any Calendar Year more than [***] after the end of [***], (b) be conducted more than [***] in any [***] period, or (c) [***]. Except as provided below, the cost of this examination will be borne by the Party that requested the examination, unless the audit reveals a variance of more than [***] from the reported amounts, in which case the audited Party will bear the cost of the audit. Unless disputed as described below, if such audit concludes that additional payments were owed or that excess payments were made during such period, the paying Party will pay the additional amounts or the receiving Party will reimburse such excess payments, with interest from the date originally due as provided in Section 6.4.2 of this Celgene Lead Co-Co Agreement, within [***] after the date on which a written report of such audit is delivered to the Parties. In the event of a dispute regarding such books and records, including the amounts owed to a Party under Section 6.2 of this Celgene Lead Co-Co Agreement or the calculation of Allowable Expenses, Celgene Co-Co Net Sales of Celgene Program Co-Co Product or Gross Profit, the Parties will work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute [***], such dispute will be resolved in accordance with Section 12.7 of the Master Collaboration Agreement. The receiving Party will treat all information subject to review under this Paragraph 6 of this Exhibit D in accordance with the confidentiality provisions of Article 8 of the Master Collaboration Agreement and the Parties will cause any auditor or arbitrator to enter into a reasonably acceptable confidentiality agreement with the audited Party obligating such firm to retain all such financial information in confidence pursuant to a confidentiality agreement.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

D - 4


7. Definitions.

(a) “ Allocable Overhead ” means the following costs, attributable to the Profit & Loss Share, all of which will be consistent with Accounting Principles in accordance with each Party’s then-current practices and reported in a manner consistent with a standard mutually agreed upon by the Parties:

(i) [***]; and

(ii) [***].

(b) “ Allowable Expenses ” means the sum of the following costs and expenses incurred during the term the Profit & Loss Share is applicable, as set forth in Paragraph 5 of this Exhibit D , which will coincide with the Celgene Co-Co Term, by the Parties, their Affiliates or Sublicensees, pursuant to the Commercialization, including Manufacturing, of Celgene Program Co-Co Products in accordance with this Celgene Lead Co-Co Agreement, during the applicable Calendar Quarter or the applicable Calendar Year: [***], in each case that are incurred in accordance with the Co-Co Commercialization Budget, the Celgene Co-Co Development Budget and the terms and conditions of this Celgene Lead Co-Co Agreement.

(c) “ Celgene Co-Co Development Costs ” means on a Celgene Program Co-Co Product-by- Celgene Program Co-Co Product basis, the costs actually incurred by the Parties, their Affiliates or Sublicensees, in accordance with the Celgene Co-Co Development Budget with respect to those Development activities performed pursuant to the Celgene Co-Co Development Plan, from and after the Celgene Lead Co-Co Agreement Effective Date. In determining “Celgene Co-Co Development Costs” chargeable under this Celgene Lead Co-Co Agreement will be calculated using [***].

(d) “ Costs of Goods Sold ” or “ COGS ” means the sum of (i) [***], (ii) [***], (iii) [***], and (iv) [***].

(e) “ Distribution Costs ” means the costs, including [***] to the distribution of a Celgene Program Co-Co Product for ROW Territory Administration or for NA Territory Administration, in each case for end use by a Party and reported in a manner mutually agreed upon by the Parties, including [***] to the extent not reimbursed by a Third Party.

(f) “ Gross Profit ” means Celgene Co-Co Net Sales of Celgene Program Co-Co Product less Cost of Goods Sold for sales of such Celgene Program Co-Co Product.

(g) “ Manufacturing Costs ” means costs to supply [***] (i) supplied by [***], or (ii) manufactured directly by either Party or its Affiliates or Sublicensees; it being understood and agreed that (A) in the case of costs referred to in subsection (i) of this sentence where [***] is the manufacturer, Manufacturing Costs will equal [***] of the amounts invoiced by (1) [***] and (2) [***] engaged by such Party or its Affiliates to provide [***], and (B) in the case of costs referred to in subsection (ii) of this sentence where either Party or one of its Affiliates or its Sublicensees is the manufacturer, Manufacturing Costs will equal the [***], which manufacturing costs: (x) will include [***] allocable to the applicable Celgene Program Co-Co Product, and (y) will be calculated in accordance with its Accounting Principles and the manufacturing party’s [***], and (z) notwithstanding anything to the contrary, will exclude [***]. Overhead included in Manufacturing Costs incurred with respect to activities conducted at the same facility for [***], will each be allocated on a reasonable basis that is mutually agreed upon by the Parties.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

D - 5


(h) “ Marketing Costs ” means [***] costs incurred by the Parties, their Affiliates or Sublicensees, arising from activities [***] of Celgene Program Co-Co Product (i.e., [***] related to the Celgene Program Co-Co Product and approved by the JSC, in each case that are incurred in accordance with the Celgene Co-Co Commercialization Budget. Such costs will include [***]. Marketing Costs will also include [***]. Marketing Costs will specifically exclude the costs of [***].

(i) “ Operating Profits or Losses ” means Gross Profit for Celgene Program Co-Co Product less the Allowable Expenses. The Parties agree that Operating Profit or Loss will not include costs or expenses of a Party or its Affiliates or Sublicensees that are: (i) [***], or (ii) subject to [***] (and for clarity, if [***] will not be included in the calculation of Operating Profit or Loss).

(j) “ Other Operating Income/Expense ” means the following items, to the extent incurred with respect to and reasonably related to the Commercialization of Celgene Program Co-Co Product with respect to the relevant country(ies) under this Celgene Lead Co-Co Agreement:

(i) [***];

(ii) [***];

(iii) [***];

(iv) [***];

(v) [***]; and

(vi) [***].

(k) “ Pharmacovigilance Expenses ” means those expenses incurred [***].

(l) “ Product Recall Expenses ” means [***], except to the extent already allocated pursuant to subsection (h).

(m) “ Regulatory Expenses ” means all costs incurred, with respect to Celgene Program Co-Co Product in the relevant country(ies) to [***] during the Celgene Co-Co Term and pursuant to this Celgene Lead Co-Co Agreement, that are specifically identifiable or reasonably allocable to [***], including without limitation [***].

(n) “ Sales Costs ” means costs, arising from activities expressly set forth in the Celgene Co-Co Commercialization Plan or otherwise approved by the JSC or JCC which are

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

D - 6


[***]. Subject to the foregoing, “Sales Costs” will include [***], consisting of [***], all to the extent such costs are set forth in the Celgene Co-Co Commercialization Budget or otherwise approved by the JSC or JCC. “Sales Costs” will include [***]. A mutually agreeable methodology for determining such costs which [***] will be set forth in the Celgene Co-Co Commercialization Budget.

(o) “ Sublicense Revenues ” means [***] received by either Party or its Affiliates from a Sublicensee as consideration for the grant of a sublicense under the licenses granted with respect to Celgene Program Co-Co Product.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

D - 7


EXHIBIT E

Form of Celgene Co-Co Material Transfer Agreement

This Celgene Co-Co Material Transfer Agreement No.          (the “ Celgene Co-Co Material Transfer Agreement ”) is made as of                      (the “ Celgene Co-Co Material Transfer Agreement Effective Date ”), pursuant to that certain Celgene Lead Co-Co Agreement for the [ List Program ] Program, entered into by Juno Therapeutics, Inc., Celgene Corporation and Celgene RIVOT Investment Company II, LLC, with an effective date of [●], 20      (the “ [ List Program ] Program Celgene Lead Co-Co Agreement ”), by and between:

Transferring Party: [Please identify transferring party]

And

Celgene Co-Co Material Receiving Party: [Please identify receiving party]

for the transfer of:

A. Confidential Information:

[Please identify any Confidential Information other than Celgene Co-Co Materials that would be transferred, e.g., assay protocols. If none, state “None.”]

B. Co-Co Materials:

[Please identify all Co-Co Materials to be transferred by type and name, as well as specifying the amount transferred. If none, state “None.”]

for the following Program(s):

 

  ¨ [                      ] Program

 

  ¨             

and for the purpose of:

[Please describe purpose and scope of use of such Confidential Information and/or Co-Co Materials]

The Parties acknowledge and agree that the transfer of Confidential Information and/or Celgene Co-Co Materials pursuant to this Celgene Co-Co Material Transfer Agreement will be pursuant to and in accordance with the terms and conditions of the Master Collaboration Agreement and this [ list Program ] Celgene Lead Co-Co Agreement. Any capitalized terms used in this Celgene Co-Co Material Transfer Agreement that are not defined herein have the meanings ascribed to them in the Master Collaboration Agreement or the [ list Program ] Celgene Lead Co-Co Agreement, as applicable.

[ Signature Page Follows ]

 

E-1


IN WITNESS WHEREOF, this Celgene Co-Co Material Transfer Agreement is entered into as of the Celgene Co-Co Material Transfer Agreement Effective Date, and it is accepted and agreed to by the Parties’ authorized representatives.

 

For the Co-Co Materials Transferring Party:    For the Co-Co Materials Receiving Party:

By:

 

 

     By:   

 

Name:

 

 

     Name:   

 

Title:

 

 

     Title:   

 

 

 

E-2


EXHIBIT F

Commercialization Opt-In Terms

If Juno delivers a Juno Co-Commercialization Notice to Celgene pursuant to Section 3.1.2 Juno shall have the right to participate in the following Commercialization Activities relating to the Commercialization of Celgene Program Co-Co Products in the Major EU Market Countries or the North America Territory (in each case, where Juno delivers a Juno Co-Commercialization Notice to Celgene) and in such case the following terms shall apply to the conduct of the Commercialization Activities:

1.1 Celgene Responsibilities . Following Juno’s exercise of the Commercialization Opt-In Right, Celgene shall remain responsible for:

(a) the form and content of the Commercialization Plan for Commercialization of Celgene Program Co-Co Products for ROW Territory Administration, [***], and for all activities relating to the Commercialization of Celgene Program Co-Co Products;

(b) booking all sales of Celgene Program Co-Co Products in the relevant territory;

(c) execution of [***], including [***], and [***], including [***]; and

(d) all market access activities, including [***] in the relevant territory.

1.2 Commercialization Activities . Juno shall have the right to participate in certain Commercialization Activities relating to the Celgene Program Co-Co Products as set forth in Section 3.1.6.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

F-1


EXHIBIT G

Form of Press Release

 

G-1


EXHIBIT H

Certain U.S. Federal Income Tax Matters

[***]

 

[***] Seven pages have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

H-1


SCHEDULE 3.1.6(b)

Minimum Sales Representative Qualifications

 

  [***].

 

  [***].

 

  [***].

 

  [***].

 

  [***].

 

  [***].

 

  [***].

 

  [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


SCHEDULE 6.1.1

Patents Licensed to Juno


SCHEDULE 6.1.2

Patents Licensed to Celgene


EXHIBIT D

FORM OF MATERIAL TRANSFER AGREEMENT

TO BE ATTACHED

 


SCHEDULE 1.25

CELGENE EXCLUDED PROGRAMS

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


SCHEDULE 1.37

CELGENE TARGETS

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


SCHEDULE 3.1.5

[***] Post-Option Exercise Agreements*

* If an Option is not exercised by a Party for [***].

** In each case where the specified agreement is a License Agreement, subject to Section 3.1.4 (including limitations regarding the Maximum Number of Co-Promote Rights), Celgene shall have the right to exercise the Celgene Co-Promote Right for the applicable Program, and in such case the applicable Development and Commercialization Agreement would be a Juno Lead Co-Co Agreement.

Note: All references to [***] P&L share are to [***] Juno, [***] Celgene.

 

Party Exercising
Original Option

 

Original Type of
Program

    

Agreement for
Designated Program**

  Party
offering [***]
  Party
offering [***]
  

Option Exercise for
[***]; Party Exercising

  

Post Option
Agreement for [***]

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

 

[***] Six pages have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 


SCHEDULE 7.3.6(c)

CORE COUNTRIES

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Exhibit 10.13

FIRST AMENDMENT TO LEASE

THIS FIRST AMENDMENT TO LEASE (this “ Amendment ”) is entered into as of this 31st day of July, 2015, by and between BMR-217 th PLACE LLC, a Delaware limited liability company (“ Landlord ”), and JUNO THERAPEUTICS, INC., a Delaware corporation (“ Tenant ”).

RECITALS

A. WHEREAS, Landlord and Tenant are parties to that certain Lease dated as of February 2, 2015 (as the same may have been amended, supplemented or modified from time to time, the “ Existing Lease ”), whereby Tenant leases certain premises (the “ Premises ”) from Landlord at 1522 217 th Place, Bothell, Washington 98021 (the “ Building ”);

B. WHEREAS, Landlord and Tenant have determined that it is advisable to perform certain work with respect to the roof and roof membrane of the Building (collectively, the “ Roof ”) as more particularly described in the scope of work attached hereto as Exhibit A (the “ Roof Work ”);

C. WHEREAS, pursuant to Section 17.2 of the Lease, Landlord, at Landlord’s sole cost and expense, is responsible for capital repairs and replacements (if necessary, as reasonably determined by Landlord) of the Building roof covering, structural system and membrane;

D. WHEREAS, Landlord and Tenant have agreed that Tenant’s general contractor, BNBuilders (“ Contractor ”), will perform the Roof Work pursuant to the scope of work attached hereto as Exhibit A (the “ Scope of Work ”), at Tenant’s cost, and Landlord’s shall reimburse Tenant for the cost of such Roof Work, up to a maximum amount of Five Hundred Thirty-Three Thousand Four Hundred Fifty-Two and No/100 Dollars ($533,452.00) (“ Maximum Cost ”), on the terms and conditions set forth in this Amendment; and

E. WHEREAS, Landlord and Tenant desire to modify and amend the Existing Lease only in the respects and on the conditions hereinafter stated.

AGREEMENT

NOW, THEREFORE, Landlord and Tenant, in consideration of the mutual promises contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, agree as follows:

1. Definitions . For purposes of this Amendment, capitalized terms shall have the meanings ascribed to them in the Existing Lease unless otherwise defined herein. The Existing Lease, as amended by this Amendment, is referred to collectively herein as the “ Lease .” From and after the date hereof, the term “Lease,” as used in the Existing Lease, shall mean the Existing Lease, as amended by this Amendment.

BioMed Realty form dated 3/27/15


2. Performance of Roof Work . Tenant shall cause Contractor to perform the Roof Work in accordance with the Scope of Work and the requirements set forth in Exhibit B attached hereto (the “ Additional Roof Requirements ”) in a good and workmanlike manner, free from defects and mold, in conformance with all Applicable Laws, permits and standards of the industry, using materials that are new and of good quality. If the Roof Work does not conform to these requirements, it shall be considered defective, and if Landlord delivers written notice of any such defect to Tenant, then Tenant shall cause Contractor to immediately replace and correct such defect at no additional cost to Landlord. Tenant shall cause Contractor to obtain and maintain all permits and licenses required for Contractor to perform the Roof Work, and upon Landlord’s request, Contractor shall produce evidence satisfactory to Landlord of such permits or licenses. Landlord shall cooperate with the permit process, as reasonably necessary. Tenant shall cause Contractor to comply with Landlord’s reasonable safety standards and protocols and to take commercially reasonable steps to protect the Building during the performance of the Roof Work. Tenant hereby assigns to Landlord any warranty for such Roof Work provided by Contractor. Landlord and Tenant hereby approve the Scope of Work. Landlord and Tenant have thoroughly discussed the condition of the Roof and mutually agreed that the performance of the Roof Work as described in the Scope of Work is the appropriate method for remedying any existing defects in the condition of the Roof, and that the performance of the Roof Work by Contractor in accordance with the Scope of Work and Landlord’s reimbursement of cost incurred by Tenant for Contractor to perform such Roof Work as set forth in Section 3 below satisfies any obligations of Landlord under Section 17.2 of the Lease with respect to any such existing defects.

3. Reimbursement of Cost of Roof Work . Upon completion of the Roof Work in accordance with this Amendment, Tenant shall deliver to Landlord an invoice for the cost incurred by Tenant for Contractor to perform such Roof Work, together with reasonable supporting documentation. Within thirty (30) days after receipt of such invoice and supporting documentation, Landlord shall reimburse Tenant for such cost, up to the Maximum Cost. In no event shall Landlord be required to pay any amount for the Roof Work in excess of the Maximum Cost.

4. Roof Maintenance Obligations . From and after the completion of the Roof Work, in addition to any other obligations under the Lease, Tenant shall cause inspections of the physical condition of the Roof to be performed and written inspection reports to be prepared by a licensed roofing contractor reasonably acceptable to Landlord, which shall be a certified or authorized warranty inspector of the Roof system manufacturer (“ Roof Maintenance Contractor ”), and shall cause a Roof Maintenance Contractor to perform regular maintenance of the Roof, all in accordance with the Additional Roof Requirements; provided , however , that at all times during the Term, notwithstanding anything set forth in the Additional Roof Requirements, Landlord shall have the right to perform its own inspections and maintenance of the Roof, subject to the notice and access provisions in the Lease. Landlord hereby approves Cobra BEC, Inc. as the Roof Maintenance Contractor.

5. No Default . Landlord and Tenant represent, warrants and covenant to one another that, to the best of their respective knowledge, Landlord and Tenant are not in default of any of their respective obligations under the Existing Lease and no event has occurred that, with the passage of time or the giving of notice (or both) would constitute a default by either Landlord or Tenant thereunder.

 

2


6. Notices . Tenant confirms that, notwithstanding anything in the Lease to the contrary, notices delivered to Tenant pursuant to the Lease should be sent to:

Juno Therapeutics, Inc.

307 Westlake Avenue N., Suite 300

Seattle, WA 98109-5219

Attention: Dir. of Eng. and Capital Projects

with a copy to:

Juno Therapeutics, Inc.

307 Westlake Avenue N., Suite 300

Seattle, WA 98109-5219

Attention: General Counsel.

7. Effect of Amendment . Except as modified by this Amendment, the Existing Lease and all the covenants, agreements, terms, provisions and conditions thereof shall remain in full force and effect and are hereby ratified and affirmed. In the event of any conflict between the terms contained in this Amendment and the Existing Lease, the terms herein contained shall supersede and control the obligations and liabilities of the parties.

8. Successors and Assigns . Each of the covenants, conditions and agreements contained in this Amendment shall inure to the benefit of and shall apply to and be binding upon the parties hereto and their respective heirs, legatees, devisees, executors, administrators and permitted successors and assigns and sublessees. Nothing in this section shall in any way alter the provisions of the Lease restricting assignment or subletting.

9. Miscellaneous . This Amendment becomes effective only upon execution and delivery hereof by Landlord and Tenant. The captions of the paragraphs and subparagraphs in this Amendment are inserted and included solely for convenience and shall not be considered or given any effect in construing the provisions hereof. All exhibits hereto are incorporated herein by reference. Submission of this instrument for examination or signature by Tenant does not constitute a reservation of or option for a lease, and shall not be effective as a lease, lease amendment or otherwise until execution by and delivery to both Landlord and Tenant.

10. Authority . Tenant guarantees, warrants and represents that the individual or individuals signing this Amendment have the power, authority and legal capacity to sign this Amendment on behalf of and to bind all entities, corporations, partnerships, limited liability companies, joint venturers or other organizations and entities on whose behalf such individual or individuals have signed.

11. Counterparts; Facsimile and PDF Signatures . This Amendment may be executed in one or more counterparts, each of which, when taken together, shall constitute one and the same document. A facsimile or portable document format (PDF) signature on this Amendment shall be equivalent to, and have the same force and effect as, an original signature.

 

3


IN WITNESS WHEREOF, Landlord and Tenant have executed this Amendment as of the date and year first above written.

 

LANDLORD :

BMR-217 TH PLACE LLC,

a Delaware limited liability company

By:  

/s/ Jonathan P. Klassen

Name:   Jonathan P. Klassen
Title:   Executive Vice President
TENANT :

JUNO THERAPEUTICS, INC.,

a Delaware corporation

By:  

/s/ Andy Walker

Name:   Andy Walker
Title:   SVP, Manufacturing & Operations


LOGO

 


STATE OF WASHINGTON              )
   ) ss.
COUNTY OF KING    )

On this 28 day of July, 2015, before me, the undersigned, a Notary Public in and for the State of Washington, duly commissioned and sworn personally appeared Andy Walker, known to me to be the SVP of Manufacturing/Operations JUNO THERAPEUTICS, INC. , a Delaware corporation, the corporation that executed the foregoing instrument, and acknowledged the said instrument to be the free and voluntary act and deed of said corporation, for the purposes therein mentioned, and on oath stated that he/she was authorized to execute said instrument.

I certify that I know or have satisfactory evidence that the person appearing before me and making this acknowledgment is the person whose true signature appears on this document.

WITNESS my hand and official seal hereto affixed the day and year in the certificate above written.

 

  

/s/ Patricia Grossbard

  
   Signature   
/seal/   

Patricia Grossbard

  
   Print Name   
   NOTARY PUBLIC in and for the State of   
   Washington, residing at 307 Westlake Ave. N., Seattle, WA.
   My commission expires 05/12/2016                    .   


EXHIBIT A

SCOPE OF WORK

 

LOGO

Juno 60 mil TPO Replacement Scope

 

  1. Remove existing roofing down to structural metal decking.

 

  2. Any wet and moldy roof sections will require Tyvek suits, dust masks, and to be wrapped and sealed in polyethylene. Thrown in same dumpsters as long as it’s sealed. Any work in these areas will be coordinated with BNBuilders and other trades onsite so they are aware of activity.

 

  3. Inspect decking for any noticeable issues and notify BNBuilders.

 

  4. Loose lay 6 mill vapor barrier.

 

  5. Loose lay R-30 insulation.

 

  6. Mechanically attached  1 4 “ Dens deck cover board.

 

  7. Mechanically attached 60 mil TPO Roof system and weld seams, flashings, as required per manufacturer.

 

  8. Install of boots and flexible flashings at roof penetrations.

 

  9. Sealants as required at cut edges, boot clamps, etc.

 

  10. Weld new membrane to old membrane daily to create water tight condition

 

  11. Only remove as much roofing as can be installed in a day.

 

  12. Coordinate with McKinstry in replacement of roof drains.

 

  13. Daily inspection of newly installed areas to ensure no punctures.

 

  14. Coordination of roof protection with BNBuilders.

 

  15. Water testing in intermittent stages will occur with sprinklers and final water test will occur once work is 100% complete. We will treat any rain days as test days as well and will use the opportunity to inspect.

 

  16. Post installation Tramex Water Survey.

 

A-1


EXHIBIT B

ADDITIONAL ROOF REQUIREMENTS

General Comments:

 

  1. Landlord and/or Landlord’s consultants will be allowed access to the Roof at any time to perform independent, scheduled inspections with 48-hour prior notice to Tenant.

 

  2. Following a major storm event or reported Roof damage, Tenant shall grant Landlord and/or Landlord’s consultants prompt access to Roof to perform independent inspections, at Landlord’s election.

 

  3. Tenant will make available any invoices or field reports of all Roof repairs, maintenance and inspections performed by Tenant and/or Tenant’s contractors.

Inspections during Performance of Roof Work:

 

  4. Landlord will hire an independent roofing consultant to review submittal data, installation means and methods, and final Roof water testing.

 

  5. Tenant and its contractors will maintain an installation report (including, but not limited to) field inspections, photo documentation, and material verification. Tenant facilities group will maintain all records and documentation.

 

  6. Any corrective action or repairs to the Roof during installation will be recorded and documented in the Roof operations and maintenance manual by Tenant.

 

  7. Tenant will cause the Roof to be flood tested at completion of the Roof Work. Tenant may choose to Roof test in sections in order to maintain schedule with Landlord’s prior consent. Tenant will give Landlord and Landlord’s consultants reasonable advance notice and an opportunity to witness any Roof test and Landlord will be copied on any corrective action.

Roof Inspections and Maintenance after Completion of Roof Work:

 

  8. Tenant shall perform weekly Roof inspections. Inspections shall include the following:

 

  a. Walking the entire Roof (within fall protection perimeter).

 

  b. Checking and cleaning all Roof drains and overflows.

 

  c. Visual inspection of membrane where any larger debris have fallen (tree branches).

 

  d. Testing and repair at any areas that appear to be damaged.

 

  9. Tenant shall hire a Roof Maintenance Contractor to perform quarterly Roof maintenance in accordance with the Roof warranty, and including the following:

 

  e. Cleaning of Roof drain and over flow areas.

 

  f. Cleaning of areas that have buildup of dirt.

 

  g. Testing of gutters and downspouts to verify there is no blockage or leaks.

 

  h. Water testing or verification after rainfall of any ponding. Consult roofing contractor to minimize ponding.

 

  i. Removal of Roof drain covers and verification of bolts on clamping collar.

 

  j. Detailed inspection of any repaired areas. Moisture testing as needed.

 

  k. Inspection of caulking and replacement of any weathered or deteriorated caulk. All caulking work to be done by a roofing contractor and work performed within warranty requirements.

 

B-1

Exhibit 31.1

CERTIFICATIONS

I, Hans E. Bishop, certify that:

 

  1. I have reviewed this Quarterly Report on Form 10-Q of Juno Therapeutics, Inc.;

 

  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

  4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) 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) 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

 

  (c) 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: August 14, 2015

 

/s/ Hans E. Bishop

Hans E. Bishop

President and Chief Executive Officer

(Principal Executive Officer)

Exhibit 31.2

CERTIFICATIONS

I, Steven D. Harr, certify that:

 

  1. I have reviewed this Quarterly Report on Form 10-Q of Juno Therapeutics, Inc.;

 

  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

  4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) 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) 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

 

  (c) 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: August 14, 2015

 

/s/ Steven D. Harr

Steven D. Harr

Chief Financial Officer

(Principal Financial and Accounting Officer)

Exhibit 32.1

JUNO THERAPEUTICS, INC.

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Juno Therapeutics, Inc. (the “Company”) on Form 10-Q for the fiscal quarter ended June 30, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Hans E. Bishop, President and Chief Executive Officer ( Principal Executive Officer ) of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

 

  (1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

  (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

/s/ Hans E. Bishop

Hans E. Bishop

President and Chief Executive Officer

(Principal Executive Officer)

Date: August 14, 2015

A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

This certification accompanies the Report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Juno Therapeutics, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Report), irrespective of any general incorporation language contained in such filing.

Exhibit 32.2

JUNO THERAPEUTICS, INC.

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Juno Therapeutics, Inc. (the “Company”) on Form 10-Q for the fiscal quarter ended June 30, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Steven D. Harr, Chief Financial Officer ( Principal Financial and Accounting Officer ) of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

 

  (1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

  (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

/s/ Steven D. Harr

Steven D. Harr

Chief Financial Officer

(Principal Financial and Accounting Officer)
Date: August 14, 2015

A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

This certification accompanies the Report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Juno Therapeutics, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Report), irrespective of any general incorporation language contained in such filing.