Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 

FORM 10-Q

 

 

(Mark One)

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

For the quarterly period ended September 30, 2014

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 000-31141

 

 

INFINITY PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   33-0655706

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. Employer

Identification No.)

780 Memorial Drive, Cambridge, Massachusetts 02139

(Address of Principal Executive Offices) (Zip Code)

(617) 453-1000

(Registrant’s Telephone Number, Including Area Code)

 

 

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

Indicate by check mark whether the registrant 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 (§232.405 of this chapter) 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.

 

Large accelerated filer   x    Accelerated filer   ¨
Non-accelerated filer   ¨   (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 Exchange Act).    Yes   ¨     No   x

Number of shares of the registrant’s Common Stock, $0.001 par value, outstanding on November 3, 2014: 48,766,883

 

 

 


Table of Contents

INFINITY PHARMACEUTICALS, INC.

FORM 10-Q

FOR THE QUARTER ENDED SEPTEMBER 30, 2014

TABLE OF CONTENTS

 

         Page No.  
PART I  

FINANCIAL INFORMATION

     1   
Item 1.  

Unaudited Condensed Consolidated Financial Statements

     1   
 

Condensed Consolidated Balance Sheets as of September 30, 2014 and December 31, 2013

     1   
 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2014 and 2013

     2   
 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2014 and 2013

     3   
 

Notes to Condensed Consolidated Financial Statements

     4   
Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations      17   
Item 3.   Quantitative and Qualitative Disclosures About Market Risk      28   
Item 4.   Controls and Procedures      28   
PART II   OTHER INFORMATION      30   
Item 1A.   Risk Factors      30   
Item 5.   Other Information      46   
Item 6.   Exhibits      46   
  Signatures      46   


Table of Contents

PART I. FINANCIAL INFORMATION

Item 1. Unaudited Condensed Consolidated Financial Statements

INFINITY PHARMACEUTICALS, INC.

Condensed Consolidated Balance Sheets

(unaudited)

(in thousands, except share and per share amounts)

 

     September 30, 2014     December 31, 2013  

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 321,257      $ 68,114   

Available-for-sale securities

     57,745        145,772   

Loan commitment asset, net (note 8)

     1,681        —    

Prepaid expenses and other current assets

     10,032        11,055   
  

 

 

   

 

 

 

Total current assets

     390,715        224,941   

Property and equipment, net

     2,982        4,010   

Long-term available-for-sale securities

     533        582   

Restricted cash

     2,162        1,130   

Other assets

     433        47   
  

 

 

   

 

 

 

Total assets

   $ 396,825      $ 230,710   
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable

   $ 11,041      $ 6,375   

Accrued expenses

     18,764        9,164   

Due to Takeda, current

     6,614        6,667   

Deferred revenue, current

     21,994        —    
  

 

 

   

 

 

 

Total current liabilities

     58,413        22,206   

Due to Takeda, less current portion

     —         6,456   

Deferred revenue, less current portion

     92,367        —    

Other liabilities

     529        773   
  

 

 

   

 

 

 

Total liabilities

     151,309        29,435   

Commitments and contingencies

    

Stockholders’ equity:

    

Preferred Stock, $0.001 par value; 1,000,000 shares authorized, no shares issued and outstanding at September 30, 2014 and December 31, 2013

     —         —    

Common Stock, $0.001 par value; 100,000,000 shares authorized, and 48,725,249 and 48,227,838 shares issued and outstanding, at September 30, 2014 and December 31, 2013, respectively

     49        48   

Additional paid-in capital

     672,206        650,867   

Accumulated deficit

     (426,870     (449,796

Accumulated other comprehensive income

     131        156   
  

 

 

   

 

 

 

Total stockholders’ equity

     245,516        201,275   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 396,825      $ 230,710   
  

 

 

   

 

 

 

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

 

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INFINITY PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(unaudited)

(in thousands, except share and per share amounts)

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
     2014     2013     2014     2013  

Collaboration revenue

   $ 160,639      $ —       $ 160,639      $ —    

Operating expenses:

        

Research and development

     44,895        26,857        107,551        73,168   

General and administrative

     8,042        7,319        21,903        21,424   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     52,937        34,176        129,454        94,592   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) from operations

     107,702        (34,176     31,185        (94,592

Other income (expense):

        

Interest expense

     (4,537     —         (8,615     —    

Investment and other income

     52        238        356        737   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense)

     (4,485     238        (8,259     737   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 103,217      $ (33,938   $ 22,926      $ (93,855
  

 

 

   

 

 

   

 

 

   

 

 

 

Earnings (loss) per common share:

        

Basic

   $ 2.08      $ (0.71   $ 0.47      $ (1.96
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

   $ 2.03      $ (0.71   $ 0.46      $ (1.96
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average number of common shares outstanding:

        

Basic

     48,632,888        48,052,939        48,497,305        47,875,706   
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

     49,735,303        48,052,939        49,533,122        47,875,706   
  

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive loss:

        

Net unrealized holding gains (losses) on available-for-sale securities arising during the period

     (31     117        (25     30   
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive income (loss)

   $ 103,186      $ (33,821   $ 22,901      $ (93,825
  

 

 

   

 

 

   

 

 

   

 

 

 

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

 

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INFINITY PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Cash Flows

(unaudited)

(in thousands)

 

     Nine Months Ended September 30,  
     2014     2013  

Operating activities

  

Net income (loss)

   $ 22,926      $ (93,855

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

    

Depreciation

     1,367        1,336   

Stock-based compensation, including 401(k) match

     9,623        9,335   

Net amortization of premium/discount on available-for-sale securities

     1,128        1,570   

Non-cash interest expense on amount Due to Takeda

     158        310   

Amortization of loan commitment asset

     8,615        —    

Other, net

     25        (2

Changes in operating assets and liabilities:

    

Prepaid expenses and other assets

     637        (919

Accounts payable, accrued expenses and other liabilities

     12,522        4,787   

Due to Takeda

     (6,667     —    

Deferred revenue

     114,361        —    
  

 

 

   

 

 

 

Net cash provided by (used in) operating activities

     164,695        (77,438

Investing activities

    

Purchases of property and equipment

     (364     (1,346

Purchases of available-for-sale securities

     (21,789     (230,599

Proceeds from sales of available-for-sale securities

     —         1,031   

Proceeds from maturities of available-for-sale securities

     108,711        181,543   
  

 

 

   

 

 

 

Net cash provided by (used in) investing activities

     86,558        (49,371

Financing activities

    

Proceeds from issuances of common stock related to stock incentive plans

     2,973        4,545   

Proceeds from issuances of common stock related to employee stock purchase plan

     393        —    

Restricted cash

     (1,030     —    

Deferred transaction costs

     (446     —    
  

 

 

   

 

 

 

Net cash provided by financing activities

     1,890        4,545   
  

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

     253,143        (122,264

Cash and cash equivalents at beginning of period

     68,114        175,742   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 321,257      $ 53,478   
  

 

 

   

 

 

 

Supplemental schedule of noncash investing and financing activities

  

Loan commitment asset

   $ 9,850      $ —    

Facility fee

   $ 1,500      $ —    

Warrants issued

   $ 8,350      $ —    
  

 

 

   

 

 

 

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

 

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Infinity Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1. Organization

Infinity Pharmaceuticals, Inc. is an innovative biopharmaceutical company dedicated to discovering, developing and delivering best-in-class medicines to patients with difficult-to-treat diseases. As used throughout these unaudited, condensed consolidated financial statements, the terms “Infinity,” “we,” “us,” and “our” refer to the business of Infinity Pharmaceuticals, Inc. and its wholly owned subsidiaries.

2. Basis of Presentation

These condensed consolidated financial statements include the accounts of Infinity and its wholly owned subsidiaries. We have eliminated all significant intercompany accounts and transactions in consolidation.

The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring accruals and revisions of estimates, considered necessary for a fair presentation of the accompanying condensed consolidated financial statements have been included. Interim results for the three and nine months ended September 30, 2014 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2014.

The information presented in the condensed consolidated financial statements and related footnotes at September 30, 2014, and for the three and nine months ended September 30, 2014 and 2013, is unaudited, and the condensed consolidated balance sheet amounts and related footnotes at December 31, 2013 have been derived from our audited financial statements. For further information, please refer to the consolidated financial statements and accompanying footnotes included in our annual report on Form 10-K for the fiscal year ended December 31, 2013, which was filed with the U.S. Securities and Exchange Commission on February 25, 2014.

3. Significant Accounting Policies

Cash Equivalents and Available-For-Sale Securities

Cash equivalents and available-for-sale securities primarily consist of money market funds, U.S. government-sponsored enterprise obligations, corporate obligations and mortgage-backed securities. Corporate obligations include obligations issued by corporations in countries other than the United States, including some obligations that have not been guaranteed by governments or government agencies. We consider all highly liquid investments with maturities of three months or less at the time of purchase to be cash equivalents. Cash equivalents, which consist of money market funds, are stated at fair value. They are also readily convertible to known amounts of cash and have such short-term maturities that each presents insignificant risk of change in value due to changes in interest rates. Our classification of cash equivalents is consistent with prior periods.

We determine the appropriate classification of marketable securities at the time of purchase and reevaluate such designation at each balance sheet date. We have classified all of our marketable securities at September 30, 2014 and December 31, 2013 as “available-for-sale.” We carry available-for-sale securities at fair value, with the unrealized gains and losses reported in accumulated other comprehensive income, which is a separate component of stockholders’ equity.

We adjust the cost of available-for-sale debt securities for amortization of premiums and accretion of discounts to maturity. We include such amortization and accretion in investment and other income. The cost of securities sold is based on the specific identification method. We include in investment and other income interest and dividends on securities classified as available-for-sale.

We conduct periodic reviews to identify and evaluate each investment that is in an unrealized loss position to determine whether an other-than-temporary impairment exists. An unrealized loss exists when the current fair value of an individual security is less than its amortized cost basis. Unrealized losses on available-for-sale debt securities that are determined to be temporary, and not related to credit loss, are recorded, net of tax, in accumulated other comprehensive income.

 

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For available-for-sale debt securities in an unrealized loss position, we perform an analysis to assess whether we intend to sell or whether we would more likely than not be required to sell the security before the expected recovery of the amortized cost basis. Where we intend to sell a security or may be required to do so, the decline in fair value of the security is deemed to be other-than-temporary, and the full amount of the unrealized loss is recorded within earnings as an impairment loss.

Regardless of our intent to sell a security, we perform additional analysis on all securities in an unrealized loss position to evaluate losses associated with the creditworthiness of the security. Credit losses are identified where we do not expect to receive cash flows sufficient to recover the amortized cost basis of a security and are recorded within earnings as an impairment loss.

Segment Information

We operate in one business segment, which focuses on drug discovery and development. We make operating decisions based upon performance of the enterprise as a whole and utilize our consolidated financial statements for decision making.

All of our revenues to date have been generated under research collaboration agreements.

Basic and Diluted Net Loss per Common Share

Basic net loss per share is based upon the weighted average number of common shares outstanding during the period. Diluted net loss per share is based upon the weighted average number of common shares outstanding during the period plus the effect of additional weighted average common equivalent shares outstanding during the period when the effect of adding such shares is dilutive. Common equivalent shares result from the assumed exercise of outstanding stock options and the exercise of outstanding warrants (the proceeds of which are then assumed to have been used to repurchase outstanding stock using the treasury stock method). In addition, the assumed proceeds under the treasury stock method include the average unrecognized compensation expense of stock options that are in-the-money. This results in the “assumed” buyback of additional shares, thereby reducing the dilutive impact of stock options. The two-class method is used for outstanding warrants as it is considered to be a participating security and it is more dilutive than the treasury stock method. The following outstanding shares of common stock equivalents were excluded from the computation of net income (loss) per share attributable to common stockholders for the periods presented because including them would have been antidilutive:

 

     Three Months Ended
September 30,
     Nine Months Ended
September 30,
 
     2014      2013      2014      2013  

Stock Options

     3,711,997         6,255,772         3,715,825         6,255,772   

Warrants (excluded from treasury stock method)

     1,000,000         —          1,000,000         —    

Basic and diluted earnings (loss) per common share were determined as follows:

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2014     2013     2014     2013  
     (in thousands, except share and per share amounts)  

Basic

        

Net income (loss)

   $ 103,217      $ (33,938   $ 22,926      $ (93,855

Undistributed earnings allocated to warrants

     (2,080     —         (362     —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 101,137      $ (33,938   $ 22,564      $ (93,855
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average common shares outstanding

     48,632,888        48,052,939        48,497,305        47,875,706   
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic earnings (loss) per common share

   $ 2.08      $ (0.71   $ 0.47      $ (1.96
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

        

Net income (loss)

   $ 103,217      $ (33,938   $ 22,926      $ (93,855

Undistributed earnings allocated to warrants

     (2,034     —         (354     —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 101,183      $ (33,938   $ 22,572      $ (93,855
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average common shares outstanding

     48,632,888        48,052,939        48,497,305        47,875,706   

Effect of dilutive options

     1,102,415        —         1,035,817        —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average common shares outstanding assuming dilution

     49,735,303        48,052,939        49,533,122        47,875,706   
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted earnings (loss) per common share

   $ 2.03      $ (0.71   $ 0.46      $ (1.96
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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Comprehensive Loss

Comprehensive loss is comprised of net loss and other comprehensive income (loss). Other comprehensive income (loss) is comprised of unrealized holding gains and losses arising during the period on available-for-sale securities that are not other-than-temporarily impaired. During the nine months ended September 30, 2014, there were no reclassifications out of accumulated other comprehensive income (loss).

Stock-Based Compensation Expense

For awards granted to employees and directors, including our Employee Stock Purchase Plan, or ESPP, we measure stock-based compensation cost at the grant date based on the estimated fair value of the award and recognize it as expense over the requisite service period on a straight-line basis. We record the expense of services rendered by non-employees based on the estimated fair value of the stock option as of the respective vesting date. We use the Black-Scholes valuation model in determining the fair value of all equity awards. For awards with performance conditions, we estimate the likelihood of satisfaction of the performance conditions, which affects the period over which the expense is recognized, and recognize the expense over the requisite service period on a straight-line basis. We have no awards with market conditions.

Revenue Recognition

To date, all of our revenue has been generated under research collaboration agreements. The terms of these research collaboration agreements may include payment to us of non-refundable, upfront license fees, funding or reimbursement of research and development efforts, milestone payments if specified objectives are achieved, and/or royalties on product sales. We evaluate all deliverables within an arrangement to determine whether or not they provide value on a stand-alone basis. Based on this evaluation, the deliverables are separated into units of accounting. For each unit of accounting identified within an arrangement, we determine the period over which the performance obligation occurs. Revenue is then recognized using the proportional performance method. The proportional performance method is used when the level of effort to complete the performance obligations under an arrangement can be reasonably estimated. We recognize revenue based upon our best estimate of the selling price for an undelivered item when there is no other means to determine the fair value of that undelivered item. The process for determining the best estimate of the selling price involves significant judgment and estimates.

At the inception of each agreement that includes milestone payments, we evaluate whether each milestone is substantive on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether:

 

    the consideration is commensurate with either (1) our performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from our performance to achieve the milestone,

 

    the consideration relates solely to past performance, and

 

    the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.

In making this assessment, we evaluate factors such as the clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required, and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement. We recognize revenues related to substantive milestones in full in the period in which the substantive milestone is achieved. If a milestone payment is not considered substantive, we recognize the applicable milestone over the remaining period of performance.

We will recognize royalty revenue, if any, based upon actual and estimated net sales by the licensee of licensed products in licensed territories, and in the period the sales occur. We have not recognized any royalty revenue to date.

Research and Development Expense

Research and development expense consists of expenses incurred in performing research and development activities, including salaries and benefits, overhead expenses including facilities expenses, materials and supplies, preclinical expenses, clinical trial and related clinical manufacturing expenses, comparator drug expenses, stock-based compensation expense, depreciation of equipment, contract services, and other outside expenses. We also include as research and development expense upfront license payments related to acquired technologies which have not yet reached technological feasibility and have no alternative use. We expense research and development costs as they are incurred. Prepaid comparator drug expenses are capitalized and then recognized as expense when title transfers to us. We have been a party to collaboration agreements in which we were reimbursed for work performed on behalf of the collaborator, as well as one in which we reimbursed the collaborator for work it had performed. We record all appropriate expenses under our collaborations as research and development expense. If the arrangement provides for reimbursement of research and development expenses we record the reimbursement as revenue. If the arrangement provides for us to

 

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reimburse the collaborator for research and development expenses or achieving a development milestone for which a payment is due, as was the case with our agreement with Intellikine, Inc., or Intellikine, we record the reimbursement or the achievement of the development milestone as research and development expense. In January 2012, Intellikine was acquired by Takeda Pharmaceutical Company Limited, or Takeda, acting through its Millennium business unit. We refer to our phosphoinositide-3-kinase, or P13K, program licensor as Takeda.

Income Taxes

We use the liability method to account for income taxes. Deferred tax assets and liabilities are determined based on temporary differences between financial reporting and income tax basis of assets and liabilities, as well as net operating loss and tax credit carryforwards, and are measured using the enacted tax rates and laws that will be in effect when the differences reverse. Deferred tax assets are reduced by a valuation allowance to reflect the uncertainty associated with their ultimate realization. The effect of a change in tax rate on deferred taxes is recognized in income or loss in the period that includes the enactment date.

We use our judgment for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. We recognize any material interest and penalties related to unrecognized tax benefits in income tax expense.

Due to the uncertainty surrounding the realization of the net deferred tax assets in future periods, we have recorded a full valuation allowance against our otherwise recognizable net deferred tax assets as of September 30, 2014 and December 31, 2013.

Fair Value Measurements

We define fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. We determine fair value based on the assumptions market participants use when pricing the asset or liability. We also use the fair value hierarchy that prioritizes the information used to develop these assumptions.

We value our available-for-sale securities utilizing third party pricing services. The pricing services use many observable market inputs to determine value, including benchmark yields, reportable trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers, reference data, new issue data, monthly payment information and collateral performance. We validate the prices provided by our third party pricing services by understanding the models used, obtaining market values from other pricing sources, and confirming that those securities trade in active markets. We value the balance of the release payment due to Takeda based on a discounted cash flow model.

Property and Equipment

Property and equipment are stated at cost. Depreciation is recorded using the straight-line method over the estimated useful lives of the applicable assets. Application development costs incurred for computer software developed or obtained for internal use are capitalized. Upon sale or retirement, the cost and related accumulated depreciation are eliminated from the respective account and the resulting gain or loss, if any, is included in current operations. Amortization of leasehold improvements and capital leases is recorded as depreciation expense and included in research and development and general and administrative expense. Repairs and maintenance charges that do not increase the useful life of the assets are charged to operations as incurred. Property and equipment are depreciated over the following periods:

 

Laboratory equipment

   5 years

Computer equipment and software

   3 to 5 years

Leasehold improvements

   Shorter of lease term or useful life of asset

Furniture and fixtures

   7 years

 

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4. Stock-Based Compensation

Total stock-based compensation expense, related to all equity awards, for the three and nine months ended September 30, 2014 and 2013 comprised the following:

 

     Three Months Ended
September 30,
     Nine Months Ended
September 30,
 
     2014      2013      2014      2013  
     (in thousands)  

Effect of stock-based compensation on net loss by line item:

           

Research and development

   $ 1,760       $ 1,599       $ 5,736       $ 4,618   

General and administrative

     1,172         1,660         3,887         4,717   

As of September 30, 2014, we had approximately $19.8 million of total unrecognized compensation cost, net of estimated forfeitures, related to unvested stock options and awards under our ESPP, which are expected to be recognized over a weighted-average period of 2.4 years.

Stock Options

During the nine months ended September 30, 2014, we granted options to purchase 1,532,384 shares of our common stock at a weighted-average fair value of $7.43 and a weighted-average exercise price of $12.57. During the nine months ended September 30, 2013, we granted options to purchase 1,371,094 shares of our common stock at a weighted-average fair value of $18.35 and a weighted-average exercise price of $33.09. For the three and nine months ended September 30, 2014 and 2013, the fair values were estimated using the Black-Scholes valuation model using the following weighted-average assumptions:

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2014     2013     2014     2013  

Risk-free interest rate

     1.7     1.3     1.7     0.9

Expected annual dividend yield

     —         —         —         —    

Expected stock price volatility

     69.8     71.3     70.9     63.2

Expected term of options

     5.0 years        4.7 years        5.1 years        4.9 years   

During the nine months ended September 30, 2014, options to purchase 421,540 shares of common stock were exercised, with a weighted-average exercise price of $7.05.

Employee Stock Purchase Plan

The weighted-average fair value of each purchase right granted during the nine months ended September 30, 2014 and 2013 was $5.66 and $8.68, respectively. For the nine months ended September 30, 2014 and 2013, the fair values were estimated using the Black-Scholes valuation model using the following weighted-average assumptions:

 

     Nine Months Ended
September 30, 2014
    Nine Months Ended
September 30, 2013
 

Risk-free interest rate

     0.3     0.3

Expected annual dividend yield

     —         —    

Expected stock price volatility

     66.7     91.5

Expected term of options

     1.25 years        1.25 years   

5. Cash, Cash Equivalents and Available-for-Sale Securities

The following is a summary of cash, cash equivalents and available-for-sale securities:

 

     September 30, 2014  
     Cost      Gross
Unrealized
Gains
     Gross
Unrealized
Losses
    Estimated
Fair Value
 
     (in thousands)  

Cash and cash equivalents due in 90 days or less

   $ 321,257       $ —        $ —       $ 321,257   

Available-for-sale securities:

          

Corporate obligations due in one year or less

     42,141         18         (2     42,157   

Mortgage-backed securities due after ten years

     426         107               533   

U.S. government-sponsored enterprise obligations due in one year or less

     15,580         8         —         15,588   
  

 

 

    

 

 

    

 

 

   

 

 

 

Total available-for-sale securities

     58,147         133         (2     58,278   
  

 

 

    

 

 

    

 

 

   

 

 

 

Total cash, cash equivalents and available-for-sale securities

   $ 379,404       $ 133       $ (2   $ 379,535   
  

 

 

    

 

 

    

 

 

   

 

 

 

 

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     December 31, 2013  
     Cost      Gross
Unrealized
Gains
     Gross
Unrealized
Losses
    Estimated
Fair Value
 
     (in thousands)  

Cash and cash equivalents due in 90 days or less

   $ 68,114       $ —        $ —       $ 68,114   

Available-for-sale securities:

          

Corporate obligations due in one year or less

     103,889         18         (16     103,891   

Corporate obligations due in one to five years

     13,513         32         —         13,545   

Mortgage-backed securities due after ten years

     478         104         —         582   

U.S. government-sponsored enterprise obligations due in one year or less

     24,144         13         —         24,157   

U.S. government-sponsored enterprise obligations due in one to five years

     4,174         5         —         4,179   
  

 

 

    

 

 

    

 

 

   

 

 

 

Total available-for-sale securities

     146,198         172         (16     146,354   
  

 

 

    

 

 

    

 

 

   

 

 

 

Total cash, cash equivalents and available-for-sale securities

   $ 214,312       $ 172       $ (16   $ 214,468   
  

 

 

    

 

 

    

 

 

   

 

 

 

We held three debt securities at September 30, 2014 that had been in an unrealized loss position for less than 12 months and no debt securities that had been in an unrealized loss position for 12 months or greater. The fair value on these securities was $6.9 million. We evaluated our securities for other-than-temporary impairments based on quantitative and qualitative factors. We considered the decline in market value for these three securities to be primarily attributable to current economic and market conditions. It is not more likely than not that we will be required to sell these securities, and we do not intend to sell these securities before the recovery of their amortized cost bases. Based on our analysis, we do not consider these investments to be other-than-temporarily impaired as of September 30, 2014.

As of September 30, 2014, we held ten debt securities from financial institutions and other companies located in France, the Netherlands, the United Kingdom, Japan, Switzerland, Canada, Singapore and Sweden with a fair value of $27.5 million. There were no material unrealized losses incurred by these securities.

We had no material realized gains or losses on our available-for-sale securities for the three and nine months ended September 30, 2014 and 2013. There were no other-than-temporary impairments recognized for the three and nine months ended September 30, 2014 and 2013.

6. Fair Value

We use a valuation hierarchy for disclosure of the inputs used to measure fair value. This hierarchy prioritizes the inputs into three broad levels. Level 1 inputs, which we consider the highest level inputs, are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on our own assumptions used to measure assets and liabilities at fair value. The classification of a financial asset or liability within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement. For our fixed income securities, we reference pricing data supplied by our custodial agent and nationally known pricing vendors, using a variety of daily data sources, largely readily-available market data and broker quotes. We validate the prices provided by our third party pricing services by reviewing their pricing methods and obtaining market values from other pricing sources. After completing our validation procedures, we did not adjust or override any fair value measurements provided by our pricing services as of September 30, 2014 and December 31, 2013.

 

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The following table provides the assets carried at fair value measured on a recurring basis as of September 30, 2014:

 

     Level 1      Level 2  
     (in thousands)  

Cash and cash equivalents

   $ 320,507       $ 750   

Corporate obligations (including commercial paper)

     —          42,157   

Mortgage-backed securities

     —          533   

U.S. government-sponsored enterprise obligations

     —          15,588   
  

 

 

    

 

 

 

Total

   $ 320,507       $ 59,028   
  

 

 

    

 

 

 

The fair value of the available-for-sale securities and cash and cash equivalents (including asset types listed below with maturities of three months or less at the time of purchase) is based on the following inputs:

 

    Corporate Obligations :

 

    Commercial paper: calculations by custodian based on the three month Treasury bill published on the last business day of the month.

 

    Other: benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers and reference data.

 

    Mortgage-Backed Securities : benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers and reference data, new issue data, monthly payment information and collateral performance.

 

    U.S. Government-Sponsored Enterprise Obligations : benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers and reference data.

The amount due to Takeda is recorded at its carrying value at September 30, 2014. The fair value of the amount due to Takeda, a Level 2 measurement, was approximately $6.6 million as of September 30, 2014 and was determined using a discounted cash flow model and based on an interest rate we would be charged for a similar loan as of September 30, 2014 (see note 7).

The carrying amounts reflected in the condensed consolidated balance sheets for prepaid expenses and other current assets, other assets, accounts payable and accrued expenses approximate their fair value due to their short term maturities.

There have been no changes to the valuation methods during the nine months ended September 30, 2014. We evaluate transfers between levels at the end of each reporting period. There were no transfers of assets or liabilities between Level 1 and Level 2 during the nine months ended September 30, 2014. We had no available-for-sale securities that were classified as Level 3 at any point during the nine months ended September 30, 2014 or during the year ended December 31, 2013.

7. Collaborations

AbbVie

On September 2, 2014, we entered into a collaboration and license agreement with AbbVie Inc., or AbbVie, which we refer to as the AbbVie Agreement. Under the AbbVie Agreement, we will collaborate with AbbVie to develop and commercialize products containing duvelisib, which we refer to as Duvelisib Products, in oncology indications. Under the terms of the AbbVie Agreement, we have granted to AbbVie licenses under applicable patents, patent applications, know-how and trademarks to develop, commercialize and manufacture Duvelisib Products in oncology indications. These licenses are generally co-exclusive with rights we retain, except that we have granted AbbVie exclusive licenses to commercialize Duvelisib Products outside the United States. We and AbbVie retain the rights to perform our respective obligations and exercise our respective rights under the AbbVie Agreement, and we and AbbVie may each grant sublicenses to affiliates or third parties.

Under the AbbVie Agreement, we and AbbVie have created a governance structure, including committees and working groups to manage the development, manufacturing and commercialization responsibilities for Duvelisib Products. Generally, we and AbbVie must mutually agree on decisions, although in specified circumstances either we or AbbVie would be able to break a deadlock.

We and AbbVie share oversight of development and have each agreed to use diligent efforts, as defined in the AbbVie Agreement, to carry out our development activities under an agreed upon development plan. We have primary responsibility for the conduct of development of Duvelisib Products, except that AbbVie has responsibility for the conduct of certain contemplated combination clinical studies, which we refer to as the AbbVie Studies. We have the responsibility to manufacture Duvelisib Products until we transition manufacturing responsibility to AbbVie, which we expect to occur as promptly as practicable while ensuring continuity of supply. Excluding the AbbVie Studies, we are responsible for all costs to develop and manufacture Duvelisib Products up to a maximum amount of $667 million after which we will share Duvelisib Product development and manufacturing costs equally with AbbVie. The development and manufacturing costs for the AbbVie Studies will be shared equally.

 

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We and AbbVie share operational responsibility and decision making authority for commercialization of Duvelisib Products in the United States. Specifically, we have the primary responsibility for advertising, distribution, and booking sales, and we share certain other commercialization functions with AbbVie. Assuming regulatory approval, we and AbbVie will each provide half of the sales representative effort to promote Duvelisib Products in the United States. Outside the United States, AbbVie has, with limited exceptions, operational responsibility and decision making authority to commercialize Duvelisib Products. We and AbbVie will share the cost of manufacturing and supply for commercialization of Duvelisib Products in the United States and AbbVie will bear the cost of manufacturing and supply for commercialization of Duvelisib Products outside the United States. Prior to commercialization and regulatory approval, we will recognize these costs as a component of research and development and general and administrative expenses. Subsequent to regulatory approval and commercial launch, the cost of manufacturing will be recorded as cost of goods sold.

AbbVie has paid us a non-refundable $275 million upfront payment and has agreed to pay us up to $530 million in potential future milestone payments comprised of $130 million associated with the achievement of a specified clinical development milestone, up to $275 million associated with the achievement of specified regulatory filing and approval milestones, and up to $125 million associated with the achievement of specified commercialization milestones. Under the terms of the AbbVie Agreement, we and AbbVie will equally share commercial profits or losses of Duvelisib Products in the United States, including sharing equally the existing royalty obligations to Mundipharma International Corporation Limited, or Mundipharma, and Purdue Pharmaceutical Products L.P., or Purdue, for sales of Duvelisib Products in the United States, as well as sharing equally the existing U.S. milestone payment obligations to Takeda. Additionally, AbbVie has agreed to pay us tiered royalties on net sales of Duvelisib Products outside the United States ranging from 23.5% to 30.5%, depending on annual net sales of Duvelisib Products by AbbVie, its affiliates and its sublicensees. We are responsible for the existing royalty obligations to Mundipharma and Purdue outside the United States and to Takeda worldwide, and AbbVie has agreed to reimburse us for our existing Duvelisib Product milestone payment obligations to Takeda outside the United States. The tiered royalty from AbbVie is subject to a reduction of 4% at each tier if our royalties to Mundipharma and Purdue are reduced according to the terms of our respective agreements with them. This tiered royalty can further be reduced based on specified factors, including patent expiry, generic entry, and royalties paid to third parties with blocking intellectual property. These royalties are payable on a product-by-product and country-by-country basis until AbbVie ceases selling the product in the country.

We have evaluated the deliverables within the AbbVie Agreement to determine whether or not they provide value on a standalone basis. Based on our evaluation, we have determined that there are three deliverables: the license, the development services and the committee services, and each provides value on a stand-alone basis and represents a separate unit of accounting. We determined the best estimate of selling price for each unit of accounting using a discounted cash-flow model. The valuation for each deliverable involves significant estimates and assumptions, including but not limited to, expected market opportunity, assumed royalty rates, pricing objectives, clinical trial timelines, likelihood of success and projected costs. The resulting estimate of selling prices for the license and development services consider the benefits that have been retained by the Company.

Of the $275 million upfront payment received during the three months ended September 30, 2014, $159.1 million was allocated to the license, $115.6 million to the development services and $0.3 million to committee services. We recognized license revenue upon execution of the arrangement. Revenue related to development services and committee services are being recognized using the proportionate performance method as services are provided over the estimated service period of approximately five years. During the three and nine months ended September 30, 2014, we recognized $159.1 million of revenue related to the license and $1.5 million of revenue related to development and committee services. We have recorded the remaining amount of $114.4 million related to development and committee services as deferred revenue as of September 30, 2014.

The development, regulatory and commercialization milestones represent non-fundable amounts that would be paid by AbbVie to us if certain milestones are achieved in the future. We have elected to apply the milestones method of revenue recognition to these milestones. We have determined that all milestones, except for the first milestone, if achieved, are substantive as they relate solely to past performance, are commensurate with estimated enhancement of value associated with the achievement of each milestone as a result of our performance, which are reasonable relative to other deliverables and terms of the arrangement, and are unrelated to the delivery of any further elements under the arrangement. The clinical development milestone, which we have determined not to be substantive based on risk and effort involved, will be recognized using the same method as the upfront payment when achieved.

Subject to limited exceptions, we have agreed that we and our affiliates will not commercialize, or assist others in commercializing, in oncology indications any product that is a PI3K delta, gamma inhibitor that meets certain agreed-to criteria, other than Duvelisib Products, and AbbVie has agreed to similar restrictions. Registration directed clinical trials and commercialization of Duvelisib Products for uses outside of oncology indications would require our and AbbVie’s mutual consent.

The AbbVie Agreement will remain in effect until all development, manufacturing and commercialization of Duvelisib Products cease, unless terminated earlier. Either we or AbbVie may terminate the AbbVie Agreement if the other party is subject to certain insolvency proceedings or if the other party materially breaches the AbbVie Agreement and the breach remains uncured for a specified period, which may be extended in certain circumstances. However, we may terminate the AbbVie Agreement only on a country by country basis in the event AbbVie is not using diligent efforts to obtain regulatory approval or to commercialize Duvelisib Products in a country outside the United States. AbbVie may also terminate the AbbVie Agreement for convenience after a specified notice period. In the event there is a material uncured breach by either us or AbbVie of development or commercialization obligations, the non-breaching party may also have the right to assume and conduct such applicable development or commercialization obligations. If AbbVie or any of its affiliates or sublicensees challenges the patents we have licensed to AbbVie, we can terminate the AbbVie Agreement if the challenge is not withdrawn after a specified notice period.

If the AbbVie Agreement is terminated, we would receive all rights to the regulatory filings related to duvelisib upon our request, our license to AbbVie would terminate, and AbbVie would grant us a perpetual, irrevocable license to develop, manufacture and commercialize products containing duvelisib, excluding any compound which is covered by patent rights controlled by AbbVie or

 

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its affiliates. This license would be royalty free, unless the AbbVie Agreement is terminated for material breach, in which case, depending on the breaching party and the timing of the material breach, a royalty rate may be payable by us ranging from a low single-digit percentage to a low double-digit percentage of net sales, and, in some cases, subject to a payment cap.

If the AbbVie Agreement is terminated, there are certain wind-down obligations to ensure a smooth transition of the responsibilities of the parties including, unless the AbbVie Agreement is terminated by AbbVie for our material breach, the continued conduct of certain development and commercialization activities by AbbVie for a limited transition period and the continued funding by AbbVie of its half of the cost of the AbbVie Studies ongoing at the time of termination.

Takeda

In July 2010, we entered into a development and license agreement with Intellikine, under which we obtained rights to discover, develop and commercialize pharmaceutical products targeting the delta and/or gamma isoforms of PI3K, including duvelisib, and we paid Intellikine a $13.5 million up-front license fee. In January 2012, Intellikine was acquired by Takeda, acting through its Millennium business unit. We refer to our PI3K program licensor as Takeda. In December 2012, we amended and restated our development and license agreement with Takeda.

Under the terms of the amended and restated agreement, we retained worldwide development rights and, in exchange for an agreement to pay Takeda $15 million in installments, we regained commercialization rights for products arising from the agreement for all therapeutic indications and are solely responsible for research conducted under the agreement. During the year ended December 31, 2012, we paid $1.7 million of the $15 million, and we recorded the $15 million release payment at its fair value of $14.4 million in research and development expenses. During the nine months ended September 30, 2014, we paid to Takeda the second installment of $6.7 million. The remaining amount is due in January 2015, which we recorded as short-term liability due to Takeda on our condensed consolidated balance sheet.

In addition to developing duvelisib, we are seeking to develop our second potent, oral PI3K delta, gamma inhibitor product candidate, IPI-443, and we are seeking to identify additional novel inhibitors of PI3K-delta and/or PI3K-gamma for future development. We are obligated to pay to Takeda up to $5 million in remaining success-based milestone payments for the development of two distinct product candidates and up to $450 million in success-based milestones for the approval and commercialization of two distinct products. In February 2014, we paid Takeda a $10 million milestone payment in connection with the initiation of our Phase 3 study of duvelisib in patients with relapsed or refractory chronic lymphocytic leukemia, or CLL. We recognized the $10 million payment as research and development expense during the nine months ended September 30, 2014. In addition, we are obligated to pay Takeda tiered royalties on worldwide net sales ranging from 7% to 11% upon successful commercialization of products described in the agreement. Such royalties are payable until the later to occur of the expiration of specified patent rights and the expiration of non-patent regulatory exclusivities in a country, subject to reduction of the royalties, and, in certain circumstances, limits on the number of products subject to a royalty obligation.

The amended and restated agreement expires on the later of the expiration of certain patents and the expiration of the royalty payment terms for the products, unless earlier terminated. Either party may terminate the agreement on 75 days’ prior written notice if the other party materially breaches the agreement and fails to cure such breach within the applicable notice period, provided that the notice period is reduced to 30 days where the alleged breach is non-payment. Takeda may also terminate the agreement if we are not diligent in developing or commercializing the licensed products and do not, within three months after notice from Takeda, demonstrate to Takeda’s reasonable satisfaction that we have not failed to be diligent. The foregoing periods are subject to extension in certain circumstances. Additionally, Takeda may terminate the agreement upon 30 days’ prior written notice if we or a related party bring an action challenging the validity of any of the licensed patents, provided that we have not withdrawn such action before the end of the 30-day notice period. We may terminate the agreement at any time upon 180 days’ prior written notice. The agreement also provides for customary reciprocal indemnification obligations of the parties.

On July 29, 2014, we entered into an amendment to our agreement with Takeda, or the 2014 Takeda Amendment. Under the 2014 Takeda Amendment, we paid to Takeda a one-time upfront payment of $5 million in exchange for the option to terminate our royalty obligations to Takeda under the amended and restated agreement solely with respect to worldwide net sales in oncology indications of products containing or comprised of duvelisib. The option may be exercised by payment to Takeda of a fee of $52.5 million on or before March 31, 2015. If the option is not exercised, our royalty obligations to Takeda will remain unchanged. We recognized the $5 million upfront payment as research and development expense during the three months ended September 30, 2014 as there is no alternative future use beyond the existing research and development activities.

FAAH Program License

In August 2014, we licensed rights to our fatty acid amide hydrolase, or FAAH program, to FAAH Pharma Inc., or FAAH Pharma, a start-up company pursuing the clinical development of IPI-940 to investigate its potential to treat neuropathic pain. We received a 23% ownership in FAAH Pharma in exchange for the license. FAAH Pharma receives funding from TVM Life Science Ventures VII, L.P., or TVM, under potential milestone payments. We have elected to use the carryover basis of measurement and no gain or loss is recognized related to this transaction.

 

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Mundipharma and Purdue

Strategic Alliance Termination Agreements

On July 17, 2012, we terminated our strategic alliance with Mundipharma International Corporation Limited, or Mundipharma, and Purdue Pharmaceutical Products L.P., or Purdue, and we entered into termination and revised relationship agreements with each of those entities, which we refer to as the 2012 Termination Agreements. We considered Mundipharma, Purdue and their respective associated entities to be related parties for financial reporting purposes prior to April 2013 because of their equity ownership in us. The strategic alliance was previously governed by strategic alliance agreements that we entered into with each of Mundipharma and Purdue in November 2008. The strategic alliance agreement with Purdue was focused on the development and commercialization in the United States of products targeting FAAH. The strategic alliance agreement with Mundipharma was focused on the development and commercialization outside of the United States of all products and product candidates that inhibit or target the Hedgehog pathway, FAAH, PI3K, and product candidates arising out of our early discovery projects in all disease fields.

Under the terms of the 2012 Termination Agreements:

 

    All intellectual property rights that we had previously licensed to Mundipharma and Purdue to develop and commercialize products under the previous strategic alliance agreements terminated, with the result that we have worldwide rights to all product candidates that had previously been covered by the strategic alliance.

 

    We have no further obligation to provide research and development services to Mundipharma and Purdue as of July 17, 2012.

 

    Mundipharma and Purdue have no further obligation to provide research and development funding to us. Under the strategic alliance, Mundipharma was obligated to reimburse us for research and development expenses we incurred, up to an annual aggregate cap for each strategic alliance program other than FAAH. We did not record a liability for amounts previously funded by Purdue and Mundipharma as this relationship was not considered a financing arrangement.

 

    We are obligated to pay Mundipharma and Purdue a 4% royalty in the aggregate, subject to reduction as described below, on worldwide net sales of products that were covered by the alliance until such time as they have recovered approximately $260 million, representing the research and development funding paid to us for research and development services performed by us through the termination of the strategic alliance. After this cost recovery, our royalty obligations to Mundipharma and Purdue will be reduced to a 1% royalty on net sales in the United States of products that were previously subject to the strategic alliance. All payments are contingent upon the successful commercialization of products that were subject to the alliance, which products require significant further development. As such, there is significant uncertainty about whether any such products will ever be approved or commercialized. If no products are commercialized, no payments will be due by us to Mundipharma and Purdue; therefore, no amounts have been accrued.

Royalties are payable under these agreements until the later to occur of the last-to-expire of specified patent rights and the expiration of non-patent regulatory exclusivities in a country, provided that if royalties are payable solely on the basis of non-patent regulatory exclusivity, each of the royalty rates is reduced by 50%. In addition, royalties payable under these agreements after Mundipharma and Purdue have recovered all research and development expenses paid to us are subject to reduction on account of third party royalty payments or patent litigation damages or settlements which might be required to be paid by us if litigation were to arise, with any such reductions capped at 50% of the amounts otherwise payable during the applicable royalty payment period.

Line of Credit Agreement

In connection with the previous strategic alliance with Mundipharma and Purdue, we also entered into a line of credit agreement with Purdue and its independent associated company, Purdue Pharma L.P., or PPLP, that provided for the borrowing by us of one or more unsecured loans up to an aggregate maximum principal amount of $50 million. On September 7, 2012, upon completion of the sale and issuance of common stock to PPLP under the 2012 Securities Purchase Agreement described below, the line of credit agreement with PPLP terminated in its entirety.

 

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2012 Securities Purchase Agreement

On July 17, 2012, in connection with the termination of the strategic alliance with Mundipharma and Purdue, we executed a securities purchase agreement with PPLP, which we refer to as the 2012 Securities Purchase Agreement, under which we agreed to sell and issue 5,416,565 shares of our common stock to PPLP and two entities associated with PPLP, which we collectively refer to as the BRP entities, at a price of $14.50 per share for an aggregate consideration of approximately $78.5 million and, in connection therewith, to grant various rights to the BRP entities. The consideration was composed of extinguishment of approximately $51 million in principal and interest owed to PPLP under a line of credit agreement and $27.5 million in cash. We completed the sale and issuance on September 7, 2012 at which time the line of credit agreement with PPLP terminated in its entirety.

April 2013 Offering and 2013 Termination Agreement

On April 16, 2013, the BRP entities, through two selling stockholders, sold 11,416,565 shares in an underwritten public offering at a price of $40 per share, representing their entire holdings in our common stock. In connection with the public offering and sale of their common stock, we entered into an agreement with the BRP entities, pursuant to which the 2012 Securities Purchase Agreement, as amended in connection with the offering, terminated in its entirety. Following the closing of the offering, the BRP entities no longer owned any shares of our common stock at such time, and, as such, are no longer related parties.

8. Debt Facility Agreement

On February 24, 2014, we entered into a facility agreement with affiliates of Deerfield Management Company, L.P., or Deerfield, pursuant to which, Deerfield agreed to loan us up to $100 million, subject to the terms and conditions set forth in the facility agreement. On September 22, 2014, we amended the facility agreement with Deerfield such that the maximum principal amount that we may draw down is reduced to $50 million. We refer to the facility agreement with Deerfield, as amended, as the Facility Agreement.

Under the terms of the Facility Agreement, we may draw down on the Facility Agreement in $25 million minimum disbursements, which we refer to as the Loan Commitment, at any time on 22 business days prior notice until February 27, 2015, which we refer to as the Draw Period. Our ability to draw down under the Facility Agreement is subject to various customary conditions, including the entry into a Guaranty and Security Agreement, or Guaranty, with Deerfield and Infinity Discovery, Inc., or IDI, our a wholly-owned subsidiary, pursuant to which, as security for the repayment of our obligations under the Facility Agreement, IDI will guaranty all our obligations under the Facility Agreement and, to secure the obligations under the Facility Agreement and the Guaranty, both we and IDI will grant to Deerfield a security interest in substantially all our assets including intellectual property.

Any amounts drawn under the Facility Agreement accrue interest at a rate of 7.95% per annum, and such interest shall be payable quarterly in arrears on the first day of each June, September, December and March following the disbursement date, provided that, subject to the next sentence, during the first five interest payment dates of any draw under the Facility Agreement, we may elect to pay all or a portion of such accrued interest by adding it to the principal amount outstanding. All such accrued interest will, regardless of which draw it applies to, be payable on the last business day of the sixth calendar quarter following the date of the first draw under the Facility Agreement. We have the right to terminate the Facility Agreement and/or to prepay amounts owed under the Facility Agreement at any time, provided that, to the extent that any amount was drawn less than three years before such early termination or prepayment, we will be required to pay an additional amount equal to three years of interest on the amount being prepaid less the amount of interest previously paid on such amount. For amounts drawn under the Facility Agreement, we will be required to repay them to Deerfield in installments equal to one-third of the outstanding amount of the total principal amount drawn under the Facility Agreement on each of the third, fourth and fifth anniversaries of the first draw; the final payment, however, must be made by December 15, 2019. On February 27, 2015, or upon the earlier termination or acceleration of the facility, we are required to pay a fee equal to three percent of the difference between the $50 million commitment and the aggregate amount of disbursements under the Facility Agreement made prior to such date, which we refer to as the Facility Fee. As of September 30, 2014, we have not drawn under the Facility Agreement and have determined it probable that we will be required to pay the full Facility Fee amount of $1.5 million on February 27, 2015. We have recorded the full $1.5 million Facility Fee on the September 30, 2014 condensed consolidated balance sheet as a component of both the loan commitment asset and accrued expenses line items. The loan commitment asset is being amortized to interest expense in the condensed consolidated statements of operations and comprehensive loss on a straight line basis over the Draw Period.

Deerfield will have the right to accelerate payment of the facility in the event that we consummate a major transaction, which is generally defined as a change in control, a sale of all or substantially all of our assets, a tender or exchange offer for our common stock, a liquidation, bankruptcy, insolvency, dissolution or wind up, a delisting and/or the common stock ceases to be registered under the Securities Exchange Act of 1934, or the Exchange Act. Any amounts drawn under the Facility Agreement may become immediately due and payable upon (i) customary events of default, as defined in the Facility Agreement, or (ii) the consummation of certain major transactions, in which case Deerfield would have the right to require us to repay 100% of the principal amount of the loan, plus any accrued and unpaid interest thereon, plus any applicable additional amounts relating to a prepayment or termination, as described above.

Principal and interest under the Facility Agreement may be paid in cash or freely tradable shares of common stock at our election, subject to specified conditions at any time of conversion. The Facility Agreement contains various representations and warranties, and affirmative covenants customary for agreements of this type, including the requirement that we maintain at all times a

 

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cash, cash equivalents and available-for-sale securities balance of not less than $25 million, as well as negative covenants customary for financings of this type that are applicable upon the first draw under the Facility Agreement. Additionally, the Facility Agreement contains conditions that must be met prior to disbursements, including the condition that the number of shares of our common stock issued or issuable pursuant to all warrants following the proposed disbursement, together with payments made in our common stock under the Facility Agreement, will not exceed 9,500,000 shares, subject to appropriate adjustment to reflect any stock splits, stock combination, reclassification or similar adjustments in the number of outstanding shares of common stock.

Our total cost of securing the Loan Commitment was $11.8 million and is comprised of $8.4 million representing the fair value of the 1,000,000 warrants issued on February 24, 2014, discussed below; $3 million representing the Facility Fee; and $0.4 million of transaction costs. As a result of the amendment of the Facility Agreement, we reduced the Facility Fee by 50%, or $1.5 million and recorded a corresponding decrease in the loan commitment asset. In addition, since our borrowing capacity was reduced by 50%, the remaining loan commitment asset outstanding as of September 22, 2014 was also reduced by 50% resulting in an additional expense of $1.8 million during the three months ended September 30, 2014. The total fair value, a Level 2 measurement, is considered a Loan Commitment Asset which has been classified as a current asset on the September 30, 2014 condensed consolidated balance sheets. This amount is considered a fee to secure the Loan Commitment and is being amortized to interest expense in the three and nine months ended September 30, 2014 condensed consolidated statements of operations and comprehensive loss on a straight line basis over the Draw Period. We recorded $4.5 million and $8.6 million of interest expense associated with the amortization and write-off of the loan commitment asset pursuant to the modification of the facility for the three and nine months ended September 30, 2014, respectively.

In connection with the execution of the Facility Agreement, we issued to Deerfield warrants to purchase an aggregate of 1,000,000 shares of common stock at an exercise price of $13.83 per share, or the Initial Warrants. As noted above, pursuant to the Facility Agreement, we have the right to request from Deerfield one or more cash disbursements in the minimum amount of $25 million per disbursement, which disbursements shall be accompanied by the issuance to Deerfield of warrants, which we refer to as the Draw Warrants, to purchase an aggregate number of shares of common stock equal to 50% times the quotient of the amount of such disbursement divided by an exercise price equal to the average daily volume weighted average price per share of our common stock for a period of 20 consecutive trading days following Deerfield’s receipt of the applicable disbursement request. We refer to the Initial Warrants and the Draw Warrants individually as a Warrant or together as the Warrants. The maximum number of shares of our common stock issued or issuable pursuant to all Warrants and payments made in our common stock under the Facility Agreement is 9,500,000, subject to appropriate adjustment to reflect any stock splits, stock combination, reclassification or similar adjustments in the number of outstanding shares of common stock. The Warrants have dividend rights to the same extent as if the Warrants were exercised into shares of common stock.

Each Warrant expires on the seventh anniversary of its issuance and contains certain limitations that prevent the holder from acquiring shares upon exercise of a Warrant that would result in the number of shares beneficially owned by it exceeding 9.985% of the total number of shares of common stock then issued and outstanding.

In connection with the entry into the Facility Agreement and issuance of the Initial Warrants, we entered into a Registration Rights Agreement with Deerfield dated February 24, 2014. Pursuant to the terms of the Registration Rights Agreement, we filed, and on May 1, 2014 the Securities and Exchange Commission declared effective, a registration statement on Form S-3 registering for resale the 1,000,000 shares of common stock issuable upon the exercise of the Initial Warrants. Additionally, pursuant to the terms of the Registration Rights Agreement, we agreed to file one or more additional registration statements with the SEC to register for resale the shares of common stock issuable upon the exercise of the applicable Draw Warrants, on or prior to 30 days after issuance of each of the Draw Warrants.

9. Accrued Expenses

Accrued expenses consisted of the following:

 

     September 30,
2014
     December 31,
2013
 
     (in thousands)  

Accrued compensation and benefits

   $ 7,041       $ 1,839   

Accrued clinical studies

     4,372         4,009   

Accrued drug manufacturing costs

     2,368         991   

Accrued preclinical studies

     432         303   

Facility fee

     1,500         —    

Other

     3,051         2,022   
  

 

 

    

 

 

 

Total accrued expenses

   $ 18,764       $ 9,164   
  

 

 

    

 

 

 

 

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10. Lease

On September 25, 2014, we entered into a lease agreement, or the Lease, with BHX, LLC, as trustee of 784 Realty Trust, or the Landlord, for the lease of office space at 784 Memorial Drive, Cambridge, Massachusetts. The term of the Lease commences on November 1, 2014, which we refer to as the Commencement Date, and expires on March 31, 2025, or the Expiration Date, approximately ten years after the Commencement Date. Pursuant to the Lease, on the Commencement Date we have agreed to lease 61,000 square feet of the leased premises, which represents the entire building.

From the Commencement Date until April 1, 2015, the total base rent of the Lease will be $0.00 per month. From April 1, 2015 through March 31, 2020, the total base rent of the Lease will be $170,291.67 per month. From April 1, 2020 until the Expiration Date, the total base rent of the Lease will be $190,625.00 per month. In addition to the base rent, we are also responsible for our share of the operating expenses, utility costs and real estate taxes, in accordance with the terms of the Lease. Pursuant to the terms of the Lease, we must provide a security deposit in cash or in the form of a letter of credit in the initial amount $1 million, which may be reduced by up to $750,000 over time in accordance with the terms of the Lease. The Landlord has agreed to pay up to $5,856,100 for certain updates and repairs to be made to the Leased Premises. We are responsible for the construction and bear the risk of cost over-runs.

We have two consecutive rights to extend the term of the Lease for five years under each extension, provided that we provide notice to the Landlord no earlier than 18 months nor later than 12 months prior to expiration of the Lease. The base rent for each extension term shall be equal to 95% of the then fair market base rent per square foot for the premises.

The Lease contains customary provisions allowing the Landlord to terminate the lease if we fail to remedy a default of any of its obligations under the Lease within specified time periods or upon bankruptcy or insolvency of us.

Upon lease commencement, the building will undergo construction to suit our future needs. We will be involved in the construction project, including having responsibility to pay for a portion of the structural elements of the building and bear the risk of cost over-runs, and therefore we will be deemed for accounting purposes to be the owner of the building during the construction period. Accordingly, we will determine the fair value of the building and record it as an asset on our condensed consolidated balance sheet in November 2014, when the construction and lease commences. We will record project construction costs as an asset during the construction period and a corresponding construction financing obligation on the condensed consolidated balance sheets.

We expect to bifurcate our future lease payments into a portion that is allocated to the building and a portion that is allocated to the land on which the building is located. The portion of the lease obligations allocated to the land will be treated for accounting purposes as an operating lease commencing in November 2014.

The rent commencement date is April 1, 2015, which provides us a rent free period of five months. Upon signing the lease agreement on September 25, 2014, we paid the first month’s rent in the amount of $170,291, which we have recorded as a prepaid expense on the accompanying condensed consolidated balance sheets. In addition, we provided a letter of credit in the amount of $1.0 million to our landlord as security for the lease. The letter of credit plus the associated bank fee of $30,000 has been recorded in our accompanying condensed consolidated balance sheets as restricted cash.

Future minimum payments, excluding operating costs and taxes, under the Lease, are as follows:

 

     Facility Leases  
     (in thousands)  

Years Ending December 31:

  

2015

   $ 1,362   

2016

     2,044   

2017

     2,044   

2018

     2,044   

2019

     2,044   

2020 and beyond

     11,947   
  

 

 

 

Total minimum lease payments

   $ 21,485   
  

 

 

 

 

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11. Subsequent Event

On November 6, 2014, we entered into a Seventh Amendment to Lease, or the Lease Amendment, by and between us and ARE-770/784/790 Memorial Drive, LLC, or the Landlord, which amends that Lease Agreement originally dated July 2, 2002, as amended to date, which we refer to as the Original Lease. We shall refer to the Original Lease together with the Lease Amendment as the Memorial Drive Lease. We shall refer to the area rented under the Memorial Drive Lease as the Premises.

Under the Lease Amendment: (i) the Premises consist of 54,861 square feet, of which 3,861 square feet are located at 790 Memorial Drive, or the 790 Premises; we surrendered 13,159 square feet of the previously leased 17,020 square feet at the 790 Premises; (ii) we have extended the base term of the Memorial Drive Lease through March 31, 2025; and (iii) we have two separate five-year options to extend the term of the Memorial Drive Lease to 2035 on the same terms and conditions (other than with respect to base rent or any work letter). The Memorial Drive Lease provides that we shall continue to pay the base rent as provided in the Original Lease until January 31, 2016. The base rent shall then increase to $69.00 per square foot of the Premises on February 1, 2016 and again to $70.00 per square foot of the Premises on February 1, 2018. The Memorial Drive Lease provides that no base rent for the Premises shall be due (i) for the period commencing on February 1, 2015 through July 31, 2015, (ii) for the period commencing on February 1, 2016 through February 29, 2016, (iii) for the period commencing on February 1, 2017 through February 28, 2017, and (iv) for the period commencing on February 1, 2018 through February 28, 2018. We have also received a base building allowance of $1,097,220, or $20.00 per square foot, for the design and construction of capital improvements to the 780 Premises and a tenant improvement allowance of $1,920,135, or $35.00 per square foot, for the design and construction of additional alterations to the Premises.

We are currently evaluating the accounting for this transaction, which will be reflected in our Form 10-K for the fiscal year ending December 31, 2014.

 

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

Forward-Looking Information

The following discussion of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes included elsewhere in this report. Some of the information contained in this discussion and analysis and set forth elsewhere in this report, including information with respect to our plans and strategy for our business, the possible achievement of discovery and development milestones in 2014, our future discovery and development efforts, our collaborations, and our future operating results and financial position, includes forward-looking statements that involve risks and uncertainties. We often use words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and other words and terms of similar meaning to help identify forward-looking statements, although not all forward-looking statements contain these identifying words. You also can identify these forward-looking statements by the fact that they do not relate strictly to historical or current facts. There are a number of important risks and uncertainties that could cause actual results or events to differ materially from those indicated by forward-looking statements. These risks and uncertainties include those inherent in pharmaceutical research and development, such as adverse results in our drug discovery and clinical development activities, decisions made by the U.S. Food and Drug Administration, or FDA, and other regulatory authorities with respect to the development and commercialization of our product candidates, our ability to obtain, maintain and enforce intellectual property rights for our product candidates, our dependence on our alliance partners, competition, our ability to obtain any necessary financing to conduct our planned activities and other risk factors. You should review the section titled “Risk Factors” in Part II of this report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Unless required by law, we do not undertake any obligation to update any forward-looking statements.

Business Overview

We are an innovative biopharmaceutical company dedicated to discovering, developing and delivering best-in-class medicines to patients with difficult-to-treat diseases. We combine proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Our most advanced product candidate is duvelisib, also known as IPI-145, an oral inhibitor of the delta and gamma isoforms of phosphoinositide-3-kinase, or PI3K, which is currently being evaluated in hematologic malignancies and inflammatory diseases. In addition to duvelisib, we have a second PI3K product candidate which we refer to as IPI-443 as well as a dedicated discovery research program with a goal of generating new product candidates.

Research and Development Programs

PI3 Kinase Inhibitor Program

The PI3Ks are a family of enzymes involved in multiple cellular functions, including cell proliferation and survival, cell differentiation, cell migration and immunity. The PI3K-delta and PI3K-gamma isoforms are preferentially expressed in white blood cells, where they have distinct and mostly non-overlapping roles in immune cell development and function. Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities to develop differentiated therapies for the treatment of hematologic malignancies and inflammatory diseases. Our lead product candidate, duvelisib, is an oral inhibitor of Class I PI3K-delta and PI3K-gamma. We are investigating duvelisib in both hematologic malignancies and inflammatory diseases. We believe that duvelisib is the only inhibitor of PI3K-delta and gamma being investigated in Phase 3 clinical trials.

Hematologic Malignancies

We are conducting DUETTS TM ( Du v e lisib T rials in Hema t ologic Malignancie s ), a worldwide investigation of duvelisib in blood cancers. As part of the DUETTS program, we are conducting DYNAMO TM , a Phase 2, open-label, single arm study evaluating the safety and efficacy of duvelisib dosed at 25mg twice daily, or BID, in approximately 120 patients with indolent non-Hodgkin lymphoma, or iNHL, including follicular lymphoma, marginal zone lymphoma and small lymphocytic lymphoma, or SLL, whose disease is refractory to radioimmunotherapy or both rituximab and chemotherapy. Patients enrolled in the study must have progressed within six months of receiving their last therapy. The primary endpoint of the study is response rate according to the International Working Group Criteria, or IWGC. The FDA has granted orphan drug designation to duvelisib for the potential treatment of follicular

 

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lymphoma, the most common subtype of iNHL. We intend to expand the DUETTS program in lymphoma in 2014 with the initiation of DYNAMO+R, a Phase 3 study of duvelisib in combination with rituximab, a monoclonal antibody therapy, in patients with previously treated follicular lymphoma as well as the initiation of a Phase 1b/2 clinical study of duvelisib in combination with obinutuzumab, a monoclonal antibody treatment, or rituximab, in patients with previously untreated iNHL.

Additionally, under the DUETTS program we are enrolling patients in DUO TM , a Phase 3 study of duvelisib in patients with chronic lymphocytic leukemia, or CLL. This randomized study is designed to evaluate the safety and efficacy of duvelisib dosed at 25 mg BID compared to ofatumumab, a monoclonal antibody therapy, in approximately 300 patients with relapsed or refractory CLL. The primary endpoint of the study is progression-free survival. The FDA and the European Medicines Agency, or EMA, have granted orphan drug designation to duvelisib for the potential treatment of CLL and SLL. We intend to further expand the DUETTS program in CLL in 2014 with the initiation of a Phase 1b trial of duvelisib in combination with obinutuzumab in CLL patients whose disease has progressed following treatment with a Bruton’s tyrosine kinase, or BTK, inhibitor.

These trials are supported by data from our ongoing Phase 1, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics and clinical activity of duvelisib in patients with advanced hematologic malignancies. The dose-escalation portion of the trial is complete, with the maximum tolerated dose defined at 75 mg BID. We are continuing to evaluate duvelisib across two 25mg BID expansion cohorts in patients with relapsed/refractory CLL, iNHL and mantle cell lymphoma, or MCL, and treatment-naïve CLL in high-risk patients (patients over age 65 or having either of two genetic abnormalities known as a 17p deletion or p53 mutation). Additionally, we are continuing to evaluate duvelisib across five 75mg BID expansion cohorts in patients with relapsed/refractory CLL, iNHL and MCL; T-cell lymphomas; aggressive B-cell lymphomas; myeloid neoplasms; and T-cell or B-cell acute lymphoblastic leukemia/lymphoma. Data from this study, presented in December 2013 at the Annual Meeting of the American Society for Hematology, or ASH, and in January 2014 at the 6 th Annual T-Cell Lymphoma Forum, showed that duvelisib is clinically active in CLL, iNHL, and T-Cell lymphoma, as well as other hematologic malignancies.

An investigator-sponsored Phase 1b, open-label study of duvelisib in patients with B-cell NHL, CLL and T-cell lymphoma in combination with rituximab, bendamustine (a chemotherapy) or both rituximab and bendamustine is also open for enrollment.

We are pursuing duvelisib in oncology in collaboration with AbbVie Inc., or AbbVie.

Inflammatory and Autoimmune Diseases

In additional to hematologic malignancies, we are evaluating duvelisib in inflammatory and autoimmune diseases. In October 2014, we announced topline data from our Phase 2a exploratory study of duvelisib in patients with mild, allergic asthma. This randomized, double-blind, placebo-controlled study was designed to evaluate the activity and safety of duvelisib in 50 patients with mild, allergic asthma following an inhalational allergen challenge. The study’s primary endpoint of significantly improving the maximum early-phase or late-phase asthmatic response as measured by FEV 1  (a standard lung function test that measures the amount of air that can be exhaled in one second) was not met at any of the doses tested. However, clinical improvement in the late-phase response was observed at the 25 mg BID dose (p = 0.052) and multiple pre-specified secondary efficacy endpoints were significantly positive at the 25 mg BID dose, including an improvement in FEV 1  area under the curve over the entire assessment period (p = 0.013) and a decrease in patients’ sensitivity to methacholine treatment, a measure of airway hyper-reactivity (p = 0.036). Additionally, the 5 mg BID and 25 mg BID doses of duvelisib significantly decreased serum levels of key mediators of airway inflammation. We expect to present the final data in a peer-reviewed setting after all analyses are complete.

Duvelisib is also being evaluated in the ASPIRA trial, a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety and pharmacokinetics of duvelisib in patients with rheumatoid arthritis, or RA. The study is expected to enroll approximately 316 adults with moderate-to-severe RA and is designed to examine three dose levels of duvelisib given twice daily for 12 weeks in combination with methotrexate compared to treatment with methotrexate alone. The primary efficacy endpoint of the study is the American College of Rheumatology 20 response rate, or ACR20, which is defined as the proportion of patients who achieve at least a 20% improvement in ACR response criteria. We expect to report data from this study in 2014.

Pipeline Expansion

We are also developing our second PI3K product candidate, an oral PI3K-delta, gamma inhibitor that we refer to as IPI-443. We have finalized the nonclinical studies of IPI-443 required for Phase 1 development. The data from these studies, in combination with the data from the two Phase 2 studies of duvelisib in inflammatory and autoimmune diseases, will guide the next steps for the development of IPI-443.

Other Programs

In addition to our clinical stage programs, we have multiple innovative projects in earlier stages of development. Through our internal discovery efforts, we discovered IPI-940, a novel, orally available inhibitor of fatty acid amide hydrolase, or FAAH. It is believed that inhibition of FAAH may enable the body to bolster its own analgesic and anti-inflammatory response and may have applicability in a broad range of pain or inflammatory conditions. In August 2014, we licensed rights to our FAAH program to FAAH Pharma Inc., or FAAH Pharma, a start-up company that will continue the clinical development of IPI-940 and investigate its potential to treat neuropathic pain. We have no continued obligation towards the program or FAAH Pharma.

 

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Strategic Alliances

AbbVie

On September 2, 2014, we entered into a collaboration and license agreement with AbbVie, which we refer to as the AbbVie Agreement. Under the AbbVie Agreement, we will collaborate with AbbVie to develop and commercialize products containing duvelisib, which we refer to as Duvelisib Products, in oncology indications. Under the terms of the AbbVie Agreement, we have granted to AbbVie licenses under applicable patents, patent applications, know-how and trademarks to develop, commercialize and manufacture Duvelisib Products in oncology indications. These licenses are generally co-exclusive with rights we retain, except that we have granted AbbVie exclusive licenses to commercialize Duvelisib Products outside the United States. We and AbbVie retain the rights to perform our respective obligations and exercise our respective rights under the AbbVie Agreement, and we and AbbVie may each grant sublicenses to affiliates or third parties.

Under the AbbVie Agreement, we and AbbVie have created a governance structure, including committees and working groups to manage the development, manufacturing and commercialization responsibilities for Duvelisib Products. Generally, we and AbbVie must mutually agree on decisions, although in specified circumstances either we or AbbVie would be able to break a deadlock.

We and AbbVie share oversight of development and have each agreed to use diligent efforts, as defined in the AbbVie Agreement, to carry out our development activities under an agreed upon development plan. We have primary responsibility for the conduct of development of Duvelisib Products, except that AbbVie has responsibility for the conduct of certain contemplated combination clinical studies, which we refer to as the AbbVie Studies. We have the responsibility to manufacture Duvelisib Products until we transition manufacturing responsibility to AbbVie, which we expect to occur as promptly as practicable while ensuring continuity of supply. Excluding the AbbVie Studies, we are responsible for all costs to develop and manufacture Duvelisib Products up to a maximum amount of $667 million after which we will share Duvelisib Product development and manufacturing costs equally with AbbVie. The development and manufacturing costs of the AbbVie Studies will be shared equally.

We and AbbVie share operational responsibility and decision making authority for commercialization of Duvelisib Products in the United States. Specifically, we have the primary responsibility for advertising, distribution, and booking sales, and we share certain other commercialization functions with AbbVie. Assuming regulatory approval, we and AbbVie will each provide half of the sales representative effort to promote Duvelisib Products in the United States. Outside the United States, AbbVie has, with limited exceptions, operational responsibility and decision making authority to commercialize Duvelisib Products. We and AbbVie will share the cost of manufacturing and supply for commercialization of Duvelisib Products in the United States, and AbbVie will bear the cost of manufacturing and supply for commercialization of Duvelisib Products outside the United States.

AbbVie has paid us a non-refundable $275 million upfront payment and has agreed to pay us up to $530 million in potential future milestone payments comprised of $130 million associated with the achievement of a specified clinical development milestone, up to $275 million associated with the achievement of specified regulatory filing and approval milestones, and up to $125 million associated with the achievement of specified commercialization milestones. Under the terms of the AbbVie Agreement, we and AbbVie will equally share commercial profits or losses of Duvelisib Products in the United States, including sharing equally the existing royalty obligations to Mundipharma International Corporation Limited, or Mundipharma, and Purdue Pharmaceutical Products L.P., or Purdue, for sales of Duvelisib Products in the United States, as well as sharing equally the existing U.S. milestone payment obligations to Takeda Pharmaceutical Company Limited, or Takeda. Additionally, AbbVie has agreed to pay us tiered royalties on net sales of Duvelisib Products outside the United States ranging from 23.5% to 30.5%, depending on annual net sales of Duvelisib Products by AbbVie, its affiliates and its sublicensees. We are responsible for the existing royalty obligations to Mundipharma and Purdue outside the United States and to Takeda worldwide, and AbbVie has agreed to reimburse us for our existing Duvelisib Product milestone payment obligations to Takeda outside the United States. The tiered royalty from AbbVie is subject to a reduction of 4% at each tier if our royalties to Mundipharma and Purdue are reduced according to the terms of our agreements with Mundipharma and Purdue. This tiered royalty can further be reduced based on specified factors, including patent expiry, generic entry, and royalties paid to third parties with blocking intellectual property. These royalties are payable on a product-by-product and country-by-country basis until AbbVie ceases selling the product in the country.

Subject to limited exceptions, we have agreed that we and our affiliates will not commercialize, or assist others in commercializing, in oncology indications any product that is a PI3K delta, gamma inhibitor that meets certain agreed-to criteria, other than Duvelisib Products, and AbbVie has agreed to similar restrictions. Registration directed clinical trials and commercialization of Duvelisib Products for uses outside of oncology indications would require our and AbbVie’s mutual consent.

The AbbVie Agreement will remain in effect until all development, manufacturing and commercialization of Duvelisib Products cease, unless terminated earlier. Either we or AbbVie may terminate the AbbVie Agreement if the other party is subject to certain insolvency proceedings or if the other party materially breaches the AbbVie Agreement and the breach remains uncured for a specified period, which may be extended in certain circumstances. However, we may terminate the AbbVie Agreement only on a country by country basis in the event AbbVie is not using diligent efforts to obtain regulatory approval or to commercialize Duvelisib Products in a country outside the United States. AbbVie may also terminate the AbbVie Agreement for convenience after a specified notice period. In the event there is a material uncured breach by either us or AbbVie of development or commercialization obligations, the non-breaching party may also have the right to assume and conduct such applicable development or commercialization obligations. If AbbVie or any of its affiliates or sublicensees challenges the patents we have licensed to AbbVie, we can terminate the AbbVie Agreement if the challenge is not withdrawn after a specified notice period.

 

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If the AbbVie Agreement is terminated, we would receive all rights to the regulatory filings related to duvelisib upon our request, our license to AbbVie would terminate, and AbbVie would grant us a perpetual, irrevocable license to develop, manufacture and commercialize products containing duvelisib, excluding any compound which is covered by patent rights controlled by AbbVie or its affiliates. This license would be royalty free, unless the AbbVie Agreement is terminated for material breach, in which case, depending on the breaching party and the timing of the material breach, a royalty rate may be payable by us ranging from a low single-digit percentage to a low double-digit percentage of net sales, and, in some cases, subject to a payment cap.

If the AbbVie Agreement is terminated, there are certain wind-down obligations to ensure a smooth transition of the responsibilities of the parties.

Takeda

In July 2010, we entered into a development and license agreement with Intellikine, Inc., or Intellikine, under which we obtained rights to discover, develop and commercialize pharmaceutical products targeting the delta and/or gamma isoforms of PI3K, including duvelisib, and we paid Intellikine a $13.5 million upfront license fee. In January 2012, Intellikine was acquired by Takeda, acting through its Millennium business unit. We refer to our PI3K program licensor as Takeda. In December 2012, we amended and restated our development and license agreement with Takeda.

Under the terms of the amended and restated agreement, we retained worldwide development rights and in exchange for an agreement to pay Takeda $15 million in installments, we regained commercialization rights for products arising from the agreement for all therapeutic indications and are solely responsible for research conducted under the agreement.

In addition to developing duvelisib, we are seeking to develop our second potent, oral PI3K- delta, gamma inhibitor product candidate, IPI-443, and we are seeking to identify additional novel inhibitors of PI3K-delta and/or PI3K-gamma for future development. We are obligated to pay to Takeda up to $5 million in remaining success-based milestone payments for the development of two distinct product candidates and up to $450 million in success-based milestones for the approval and commercialization of two distinct products. In February 2014, we paid Takeda a $10 million milestone payment in connection with the initiation of our Phase 3 study of duvelisib in patients with relapsed or refractory CLL. In addition, we are obligated to pay Takeda tiered royalties on worldwide net sales ranging from 7% to 11% upon successful commercialization of products described in the agreement. Such royalties are payable until the later to occur of the expiration of specified patent rights and the expiration of non-patent regulatory exclusivities in a country, subject to reduction of the royalties, and, in certain circumstances, limits on the number of products subject to a royalty obligation.

The amended and restated agreement expires on the later of the expiration of certain patents and the expiration of the royalty payment terms for the products, unless earlier terminated. Either party may terminate the agreement on 75 days’ prior written notice if the other party materially breaches the agreement and fails to cure such breach within the applicable notice period, provided that the notice period is reduced to 30 days where the alleged breach is non-payment. Takeda may also terminate the agreement if we are not diligent in developing or commercializing the licensed products and do not, within three months after notice from Takeda, demonstrate to Takeda’s reasonable satisfaction that we have not failed to be diligent. The foregoing periods are subject to extension in certain circumstances. Additionally, Takeda may terminate the agreement upon 30 days’ prior written notice if we or a related party bring an action challenging the validity of any of the licensed patents, provided that we have not withdrawn such action before the end of the 30-day notice period. We may terminate the agreement at any time upon 180 days’ prior written notice. The agreement also provides for customary reciprocal indemnification obligations of the parties.

On July 29, 2014, we entered into an amendment to our agreement with Takeda, or the 2014 Takeda Amendment. Under the 2014 Takeda Amendment, we paid to Takeda a one-time upfront payment of $5 million in exchange for the option to terminate our royalty obligations to Takeda under the amended and restated agreement solely with respect to worldwide net sales in oncology indications of products containing or comprised of duvelisib. The option may be exercised by payment to Takeda of a fee of $52.5 million on or before March 31, 2015. If the option is not exercised, our royalty obligations to Takeda will remain unchanged.

Mundipharma and Purdue

On July 17, 2012, we terminated our strategic alliance with Mundipharma and Purdue and we entered into termination and revised relationship agreements with each of those entities, which we refer to as the 2012 Termination Agreements. The strategic alliance was previously governed by strategic alliance agreements that we entered into with each of Mundipharma and Purdue in November 2008. The strategic alliance agreement with Purdue was focused on the development and commercialization in the United States of products targeting FAAH. The strategic alliance agreement with Mundipharma was focused on the development and commercialization outside the United States of all products and product candidates that inhibit or target the Hedgehog pathway, FAAH, PI3K and product candidates arising out of our early discovery projects in all disease fields.

 

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Under the terms of the 2012 Termination Agreements:

 

    All intellectual property rights that we had previously licensed to Mundipharma and Purdue to develop and commercialize products under the previous strategic alliance agreements terminated, with the result that we have worldwide rights to all product candidates that had previously been covered by the strategic alliance.

 

    We have no further obligation to provide research and development services to Mundipharma and Purdue as of July 17, 2012.

 

    Mundipharma and Purdue have no further obligation to provide research and development funding to us. Under the strategic alliance, Mundipharma was obligated to reimburse us for research and development expenses we incurred, up to an annual aggregate cap for each strategic alliance program other than FAAH. We did not record a liability for amounts previously funded by Purdue and Mundipharma as this relationship was not considered a financing arrangement.

 

    We are obligated to pay Mundipharma and Purdue a 4% royalty in the aggregate, subject to reduction as described below, on worldwide net sales of products that were covered by the alliance until such time as they have recovered approximately $260 million, representing the research and development funding paid to us for research and development services performed by us through the termination of the strategic alliance. After this cost recovery, our royalty obligations to Mundipharma and Purdue will be reduced to a 1% royalty on net sales in the United States of products that were previously subject to the strategic alliance. All payments are contingent upon the successful commercialization of products that were subject to the alliance, which products require significant further development. As such, there is significant uncertainty about whether any such products will ever be approved or commercialized. If no products are commercialized, no payments will be due by us to Mundipharma and Purdue; therefore, no amounts have been accrued.

Royalties are payable under these agreements until the later to occur of the last-to-expire of specified patent rights and the expiration of non-patent regulatory exclusivities in a country, provided that if royalties are payable solely on the basis of non-patent regulatory exclusivity, each of the royalty rates is reduced by 50%. In addition, royalties payable under these agreements after Mundipharma and Purdue have recovered all research and development expenses paid to us are subject to reduction on account of third party royalty payments or patent litigation damages or settlements which might be required to be paid by us if litigation were to arise, with any such reductions capped at 50% of the amounts otherwise payable during the applicable royalty payment period.

Deerfield

On February 24, 2014, we entered into a facility agreement with affiliates of Deerfield Management Company, L.P., or Deerfield, pursuant to which, Deerfield agreed to loan us up to $100 million, subject to the terms and conditions set forth in the facility agreement. On September 22, 2014, we amended the facility agreement with Deerfield such that the maximum principal amount that we may draw down is reduced to $50 million. We refer to the facility agreement with Deerfield, as amended, as the Facility Agreement.

Under the terms of the Facility Agreement, we may draw down on the Facility Agreement in $25 million minimum disbursements, which we refer to as the Loan Commitment, at any time on 22 business days prior notice until February 27, 2015, which we refer to as the Draw Period. Our ability to draw down under the Facility Agreement is subject to various customary conditions, including the entry into a Guaranty and Security Agreement, or Guaranty, with Deerfield and Infinity Discovery, Inc., or IDI, our a wholly-owned subsidiary, pursuant to which, as security for the repayment of our obligations under the Facility Agreement, IDI will guaranty all our obligations under the Facility Agreement and, to secure the obligations under the Facility Agreement and the Guaranty, both we and IDI will grant to Deerfield a security interest in substantially all our assets including intellectual property.

Any amounts drawn under the Facility Agreement accrue interest at a rate of 7.95% per annum, and such interest shall be payable quarterly in arrears on the first day of each June, September, December and March following the disbursement date, provided that, subject to the next sentence, during the first five interest payment dates of any draw under the Facility Agreement, we may elect to pay all or a portion of such accrued interest by adding it to the principal amount outstanding. All such accrued interest will, regardless of which draw it applies to, be payable on the last business day of the sixth calendar quarter following the date of the first draw under the Facility Agreement. We have the right to terminate the Facility Agreement and/or to prepay amounts owed under the Facility Agreement at any time, provided that, to the extent that any amount was drawn less than three years before such early termination or prepayment, we will be required to pay an additional amount equal to three years of interest on the amount being prepaid less the amount of interest previously paid on such amount. For amounts drawn under the Facility Agreement, we will be required to repay them to Deerfield in installments equal to one-third of the outstanding amount of the total principal amount drawn under the Facility Agreement on each of the third, fourth and fifth anniversaries of the first draw; the final payment, however, must be made by December 15, 2019. On February 27, 2015, or upon the earlier termination or acceleration of the facility, we are required to pay a fee equal to three percent of the difference between the $50 million commitment and the aggregate amount of disbursements under the Facility Agreement made prior to such date.

 

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Deerfield will have the right to accelerate payment of the facility in the event that we consummate a major transaction, which is generally defined as a change in control, a sale of all or substantially all of our assets, a tender or exchange offer for our common stock, a liquidation, bankruptcy, insolvency, dissolution or wind up, a delisting and/or the common stock ceases to be registered under the Securities Exchange Act of 1934, or the Exchange Act. Any amounts drawn under the Facility Agreement may become immediately due and payable upon (i) customary events of default, as defined in the Facility Agreement, or (ii) the consummation of certain major transactions, in which case Deerfield would have the right to require us to repay 100% of the principal amount of the loan, plus any accrued and unpaid interest thereon, plus any applicable additional amounts relating to a prepayment or termination, as described above.

Principal and interest under the Facility Agreement may be paid in cash or freely tradable shares of common stock at our election, subject to specified conditions at any time of conversion. The Facility Agreement contains various representations and warranties, and affirmative covenants customary for agreements of this type, including the requirement that we maintain at all times a cash, cash equivalents and available-for-sale securities balance of not less than $25 million, as well as negative covenants customary for financings of this type that are applicable upon the first draw under the Facility Agreement. Additionally, the Facility Agreement contains conditions that must be met prior to disbursements, including the condition that the number of shares of our common stock issued or issuable pursuant to all warrants following the proposed disbursement, together with payments made in our common stock under the Facility Agreement, will not exceed 9,500,000 shares, subject to appropriate adjustment to reflect any stock splits, stock combination, reclassification or similar adjustments in the number of outstanding shares of common stock.

In connection with the execution of the Facility Agreement, we issued to Deerfield warrants to purchase an aggregate of 1,000,000 shares of common stock at an exercise price of $13.83 per share, or the Initial Warrants. As noted above, pursuant to the Facility Agreement, we have the right to request from Deerfield one or more cash disbursements in the minimum amount of $25 million per disbursement, which disbursements shall be accompanied by the issuance to Deerfield of warrants, which we refer to as the Draw Warrants, to purchase an aggregate number of shares of common stock equal to 50% times the quotient of the amount of such disbursement divided by an exercise price equal to the average daily volume weighted average price per share of our common stock for a period of 20 consecutive trading days following Deerfield’s receipt of the applicable disbursement request. We refer to the Initial Warrants and the Draw Warrants individually as a Warrant or together as the Warrants. The maximum number of shares of our common stock issued or issuable pursuant to all Warrants and payments made in our common stock under the Facility Agreement is 9,500,000, subject to appropriate adjustment to reflect any stock splits, stock combination, reclassification or similar adjustments in the number of outstanding shares of common stock. The Warrants have dividend rights to the same extent as if the Warrants were exercised into shares of common stock.

Each Warrant expires on the seventh anniversary of its issuance and contains certain limitations that prevent the holder from acquiring shares upon exercise of a Warrant that would result in the number of shares beneficially owned by it exceeding 9.985% of the total number of shares of common stock then issued and outstanding.

In connection with the entry into the Facility Agreement and issuance of the Initial Warrants, we entered into a Registration Rights Agreement with Deerfield dated February 24, 2014. Pursuant to the terms of the Registration Rights Agreement, we filed, and on May 1, 2014 the Securities and Exchange Commission declared effective, a registration statement on Form S-3 registering for resale the 1,000,000 shares of common stock issuable upon the exercise of the Initial Warrants. Additionally, pursuant to the terms of the Registration Rights Agreement, we agreed to file one or more additional registration statements with the SEC to register for resale the shares of common stock issuable upon the exercise of the applicable Draw Warrants, on or prior to 30 days after issuance of each of the Draw Warrants.

Financial Overview

Revenue

To date, all of our revenue has been generated under research collaboration agreements. The terms of these research collaboration agreements may include payment to us of non-refundable, up-front license fees, funding or reimbursement of research and development efforts, milestone payments if specified objectives are achieved, and/or royalties on product sales. We evaluate all deliverables within an arrangement to determine whether or not they provide value on a stand-alone basis. Based on this evaluation, the deliverables are separated into units of accounting. For each unit of accounting identified within an arrangement, we determine the period over which the performance obligation occurs. Revenue is then recognized using the proportional performance method. The proportional performance method is used when the level of effort to complete the performance obligations under an arrangement can be reasonably estimated. We recognize revenue based upon our best estimate of the selling price for an undelivered item when there is no other means to determine the fair value of that undelivered item. The process for determining the best estimate of the selling price involves significant judgment and estimates.

 

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At the inception of each agreement that includes milestone payments, we evaluate whether each milestone is substantive on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether:

 

    the consideration is commensurate with either (1) our performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from our performance to achieve the milestone,

 

    the consideration relates solely to past performance, and

 

    the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.

In making this assessment, we evaluate factors such as the clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required, and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement. We recognize revenues related to substantive milestones in full in the period in which the substantive milestone is achieved. If a milestone payment is not considered substantive, we recognize the applicable milestone over the remaining period of performance.

We will recognize royalty revenue, if any, based upon actual and estimated net sales by the licensee of licensed products in licensed territories, and in the period the sales occur. We have not recognized any royalty revenue to date.

In the future, we may generate revenue from a combination of product sales, research and development support services and milestone payments in connection with strategic relationships, as well as royalties resulting from the sales of products developed under licenses of our intellectual property. We expect that any potential future revenue we generate will fluctuate from year to year as a result of the timing and amount of license fees, research and development reimbursement, milestone and other payments earned under our collaborative or strategic relationships and the amount and timing of payments that we earn upon the sale of our products, to the extent any are successfully commercialized.

Research and Development Expense

We are a drug discovery and development company. Our research and development expense to date has primarily consisted of the following:

 

    compensation of personnel associated with research and development activities;

 

    clinical testing costs, including payments made to contract research organizations;

 

    costs of comparator drugs used in clinical studies;

 

    costs of purchasing laboratory supplies and materials;

 

    costs of manufacturing product candidates for preclinical testing and clinical studies;

 

    costs associated with the licensing of research and development programs;

 

    preclinical testing costs, including costs of toxicology studies;

 

    fees paid to external consultants;

 

    fees paid to professional service providers for independent monitoring and analysis of our clinical trials;

 

    costs for collaboration partners to perform research activities, including development milestones for which a payment is due when achieved;

 

    depreciation of equipment; and

 

    allocated costs of facilities.

General and Administrative Expense

General and administrative expense primarily consists of compensation of personnel in executive, finance, accounting, legal, information technology infrastructure, corporate communications, corporate development, human resources and commercial functions. Other costs include facilities costs not otherwise included in research and development expense and professional fees for legal and accounting services. General and administrative expense also consists of the costs of maintaining our intellectual property portfolio.

 

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Other Income and Expense

Investment and other income typically consists of interest earned on cash, cash equivalents and available-for-sale securities, net of interest expense, amortization of warrants and other revenue and loss. Interest expense is related to the amortization of the loan commitment asset recognized under our Facility Agreement with Deerfield.

Critical Accounting Policies and Significant Judgments and Estimates

The discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make judgments, estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates, including those related to revenue recognition, accrued expenses, assumptions in the valuation of stock-based compensation and income taxes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ from those estimates.

There have been no material changes to our critical accounting policies during the nine months ended September 30, 2014. Please refer to Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our annual report on Form 10-K for the fiscal year ended December 31, 2013 for a discussion of our critical accounting policies and significant judgments and estimates.

Results of Operations

The following tables summarize our results of operations for each of the three and nine months ended September 30, 2014 and 2013, together with the change in these items in dollars and as a percentage:

 

     Three Months
Ended September 30,
             
     2014     2013     $ Change     % Change  
     (in thousands)  

Collaboration revenue

   $ 160,639      $ —        $ 160,639        —     

Research and development expense

     (44,895     (26,857     (18,038     67

General and administrative expense

     (8,042     (7,319     (723     10

Interest expense

     (4,537     —          (4,537     —     

Investment and other income

     52        238        (186     (78 )% 

 

     Nine Months
Ended September 30,
             
     2014     2013     $ Change     % Change  
     (in thousands)  

Collaboration revenue

   $ 160,639      $ —        $ 160,639        —     

Research and development expense

     (107,551     (73,168     (34,383     47

General and administrative expense

     (21,903     (21,424     (479     2

Interest expense

     (8,615     —          (8,615     —     

Investment and other income

     356        737        (381     (52 )% 

Collaboration Revenue

Collaboration revenue for the three and nine months ended September 30, 2014 relates to license and research and development revenue from our collaboration agreement with AbbVie. Of the $275 million upfront payment received during the three months ended September 30, 2014, $159.1 million was allocated to the license, $115.6 million to the development services and $0.3 million to committee services. We recognized license revenue upon execution of the arrangement. Revenue related to development services and committee services are being recognized using the proportionate performance method as services are provided over the estimated service period of approximately five years. During the three and nine months ended September 30, 2014, we recognized $159.1 million of revenue related to the license and $1.5 million of revenue related to development and committee services. We have recorded the remaining amount of $114.4 million related to development and committee services as deferred revenue as of September 30, 2014.

 

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The development, regulatory and commercialization milestones represent non-fundable amounts that would be paid by AbbVie to us if certain milestones are achieved in the future. We have elected to apply the milestones method of revenue recognition to these milestones. We have determined that all milestones, except for the first milestone, if achieved, are substantive as they relate solely to past performance, are commensurate with estimated enhancement of value associated with the achievement of each milestone as a result of our performance, which are reasonable relative to other deliverables and terms of the arrangement, and are unrelated to the delivery of any further elements under the arrangement. The first milestone which we have determined not to be substantive based on risk and effort involved will be recognized using the same method as the upfront payment when achieved.

Research and Development Expense

The $18 million increase in research and development expense for the three months ended September 30, 2014 as compared to the three months ended September 30, 2013 was primarily due to an increase of $10.9 million in clinical expenses related to clinical development activities of duvelisib and a $5 million option fee payment to Takeda in connection with the 2014 Takeda Amendment. In addition, compensation expense increased by approximately $3.2 million primarily due to contingent cash compensation recognized during the three months ended September 30, 2014. These are partially offset by a decrease of $1.1 million in clinical expenses due to the conclusion of our development of retaspimycin HCl. The $34.4 million increase in research and development expense in the nine months ended September 30, 2014 as compared to the nine months ended September 30, 2013 is primarily due to a $22 million increase in clinical expenses related to increased clinical development activities of duvelisib as well as $15 million in payments to Takeda related to a $10 million milestone payment in connection with the initiation of our Phase 3 study of duvelisib and a $5 million option fee payment in connection with the 2014 Takeda Amendment recognized during the nine months ended September 30, 2014. These are partially offset by a decrease of $4.6 million in clinical expenses due to the conclusion of our development of retaspimycin HCl.

We began to track and accumulate expenses by major program starting on January 1, 2006. These expenses primarily relate to payroll and associated expenses for personnel working on the programs, process development and manufacturing, preclinical toxicology studies, clinical trial costs and allocated costs of facilities. During the three and nine months ended September 30, 2014 and 2013, and from January 1, 2006 through September 30, 2014, we estimate that we incurred the following expenses by program:

 

Program

   Three Months Ended
September 30, 2014
     Three Months Ended
September 30, 2013
     Nine Months Ended
September 30, 2014
     Nine Months Ended
September 30, 2013
     January 1, 2006 to
September 30, 2014
 
     (in millions)  

PI3K inhibitor (1)

   $ 38.1       $ 19.9       $ 89.0       $ 51.3       $ 251.0   

Hsp90 inhibitor

     0.3         2.3         1.5         10.9         137.7   

Hedgehog pathway inhibitor

     —           0.2         0.1         1.0         164.0   

 

(1) Nine months ended September 30, 2014 includes a $10 million milestone payment and a $5 million option fee payment.

We expect expenses related to our PI3K inhibitor program to increase as we continue clinical development of duvelisib. We expect to incur minimal expenses related to our Hsp90 program and Hedgehog pathway inhibitor program as a result of the discontinuation of company-sponsored development. We do not believe that the historical costs associated with our lead drug development programs are indicative of the future costs associated with these programs, nor represent what any other future drug development programs we initiate may cost. Due to the variability in the length of time and scope of activities necessary to develop a product candidate and uncertainties related to our cost estimates and our ability to obtain marketing approval for our product candidates, accurate and meaningful estimates of the total costs required to bring our product candidates to market are not available.

Because of the risks inherent in drug discovery and development, we cannot reasonably estimate or know:

 

    the nature, timing and estimated costs of the efforts necessary to complete the development of our programs;

 

    the completion dates of these programs; or

 

    the period in which material net cash inflows are expected to commence, if at all, from the programs described above and any potential future product candidates.

There is significant uncertainty regarding our ability to successfully develop any product candidates. These risks include the uncertainty of:

 

    the scope, rate of progress and cost of our clinical trials that we or AbbVie are currently conducting or may commence in the future;

 

    the scope and rate of progress of our preclinical studies and other research and development activities;

 

    clinical trial results;

 

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    the cost and availability of comparator drugs;

 

    the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights relating to our programs under development;

 

    the terms and timing of any strategic alliance, licensing and other arrangements that we have or may establish in the future relating to our programs under development;

 

    the cost and timing of regulatory approvals;

 

    the cost of establishing clinical supplies of any product candidates; and

 

    the effect of competing technological and market developments.

General and Administrative Expense

The $0.7 million increase in general and administrative expense for the three months ended September 30, 2014 as compared to the three months ended September 30, 2013 is primarily attributable to increased compensation expense related to contingent cash compensation recognized during the three months ended September 30, 2014. General and administrative expense for the nine months ended September 30, 2014 is comparable to general and administrative expense for the nine months ended September 30, 2013.

Interest Expense

Interest expense for the three and nine months ended September 30, 2014 is related to the amortization of the loan commitment asset recognized under our Facility Agreement with Deerfield. In addition, in connection with the amendment of the Deerfield facility agreement on September 22, 2014, we reduced the loan commitment asset by 50% resulting in an additional expense of $1.8 million during the three and nine months ended September 30, 2014.

Investment and Other Income

Investment and other income decreased for the three and nine months ended September 30, 2014 as compared to the three and nine months ended September 30, 2013 primarily due to lower yields. In addition, during the nine months ended September 30, 2013, we received a non-recurring cash distribution received from one of our insurance carriers.

Liquidity and Capital Resources

We have not generated any revenue from the sale of drugs to date, and we do not expect to generate any such revenue for the next several years, if at all. We have instead relied on the proceeds from sales of equity securities, interest on investments, upfront license fees, expense reimbursement, milestones and cost sharing under our collaborations and debt to fund our operations. Our available-for-sale debt securities primarily trade in liquid markets, and the average days to maturity of our portfolio, as of September 30, 2014, is less than six months. Because our product candidates are in various stages of clinical and preclinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates or whether, or when, we may achieve profitability.

Our significant capital resources are as follows:

 

    September 30, 2014     December 31, 2013  
    (in thousands)  

Cash, cash equivalents and available-for-sale securities

  $ 379,535      $ 214,468   

Working capital

    332,302        202,735   
    Nine Months Ended September 30,  
    2014     2013  
    (in thousands)  

Cash provided by (used in):

   

Operating activities

  $ 164,695      $ (77,438

Investing activities

    86,558        (49,371

Capital expenditures (included in investing activities above)

    (364     (1,346

Financing activities

    1,890        4,545   

 

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Cash Flows

The principal use of cash in operating activities in all periods presented was related to our research and development programs. Our cash flow provided by operating activities for the nine months ended September 30, 2014 is primarily related to the $275 million upfront payment received in connection with our collaboration agreement with AbbVie. This is partially offset by a $10 million milestone payment, $6.7 million related to the second installment on a release payment and $5 million option fee payment to Takeda. Our cash flow used in operating activities in future periods may vary significantly due to various factors, including potential cash inflows from future collaboration agreements and potential cash outflows for licensing new programs from third parties. We cannot be certain whether and when we may enter into any such collaboration agreements or in-licenses.

On February 24, 2014, we entered into a Facility Agreement with Deerfield, pursuant to which Deerfield agreed to loan us up to $100 million, subject to the terms and conditions set forth in the Facility Agreement, including the condition that we at all times maintain a cash, cash equivalents and available-for-sales securities balance of not less than $25 million. Under the terms of the Facility Agreement, we may draw down funds in minimum disbursements of $25 million at any time until February 27, 2015. On September 22, 2014, we amended the facility agreement with Deerfield such that the maximum principal amount that we may draw down is reduced to $50 million. No funds were drawn under the Facility Agreement as of September 30, 2014. On February 27, 2015, or upon the earlier termination or acceleration of the Facility Agreement, we are required to pay a fee equal to 3% of the then undrawn portion of the $50 million commitment

Net cash from investing activities for the nine months ended September 30, 2014 included $21.8 million in purchases of available-for-sale securities and proceeds of $108.7 million from maturities of available-for-sale securities. Capital expenditures in the nine months ended September 30, 2014 primarily consisted of computer equipment and software.

Net cash from financing activities for the nine months ended September 30, 2014 included $3 million of proceeds from issuances of common stock from stock option exercises related to stock incentive plans, $1.0 million related to restricted cash held on deposit with a bank to collateralize a letter of credit in the name of our facility lessor in accordance with our facility lease agreement, $0.4 million of proceeds from issuances of common stock related to our employee stock purchase plan and $0.4 million of transaction costs related to the Facility Agreement with Deerfield.

Liquidity

We will need substantial additional funds to support our planned operations. We have received a $275 million upfront payment from AbbVie in connection with our collaboration agreement during the three months ended September 30, 2014. In addition, AbbVie has agreed to pay us milestone payments associated with specified development, regulatory and commercialization events, up to an aggregate of $530 million if all the milestones are achieved. In the absence of additional funding or business development activities and based on our current operating plans, we believe that our existing cash, cash equivalents and marketable securities will be adequate to satisfy our capital needs through at least the next twelve months. Our need to raise additional funds may be accelerated if our research and development expenses exceed our current expectations, if we acquire a third party, or if we acquire or license rights to additional product candidates or new technologies from one or more third parties. Our need to raise additional funds may also be accelerated for other reasons, including, without limitation, if:

 

    our product candidates require more extensive clinical or preclinical testing than we currently expect;

 

    we advance our product candidates into clinical trials for more indications than we currently expect;

 

    we advance more of our product candidates than expected into costly later stage clinical trials;

 

    we advance more preclinical product candidates than expected into early stage clinical trials;

 

    we acquire additional business, technologies, products or product candidates;

 

    the cost of acquiring raw materials for, and of manufacturing, our product candidates is higher than anticipated;

 

    the cost or quantity required of comparator drugs used in clinical studies increases;

 

    we are required, or consider it advisable, to acquire or license intellectual property rights from one or more third parties; or

 

    we experience a loss in our investments due to general market conditions or other reasons.

Historically, we have relied on our strategic alliance with Mundipharma and Purdue for a significant portion of our research and development funding needs. Mundipharma and Purdue provided us approximately $260 million in research and development funding during the term of our strategic alliance. Following the termination of the strategic alliance agreements with Mundipharma and Purdue on July 17, 2012, we no longer receive funding from Mundipharma or Purdue and must use other resources available to us to fund our research and development expenses. Our efforts to raise sufficient capital to replace the funding we previously received under the terminated strategic alliance agreements may not be successful.

 

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We have received $244.8 million of net proceeds from our public stock offerings since the termination of the strategic alliance agreements with Mundipharma and Purdue. We may continue to seek additional funding through public or private financings of equity or debt securities, but such financing may not be available on acceptable terms, if at all. In addition, the terms of our financings may be dilutive to, or otherwise adversely affect, holders of our common stock, and such terms may impact our ability to make capital expenditures or incur additional debt. We may also seek additional funds through arrangements with collaborators or other third parties, or through project financing. These arrangements would generally require us to relinquish or encumber rights to some of our technologies or product candidates, and we may not be able to enter into such agreements on acceptable terms, if at all. If we are unable to obtain additional funding on a timely basis, we may be required to curtail or terminate some or all of our development programs or to scale back, suspend or terminate our business operations.

Obligations and Off-Balance Sheet Arrangements

Since inception, we have not engaged in any off-balance sheet financing activities, including the use of structured finance, special purpose entities or variable interest entities.

Our commitments and obligations were reported in our Annual Report on Form 10-K for the year ended December 31, 2013. There were no material changes from the contractual commitments and obligations previously disclosed, except with respect to our rent payments as we entered into a lease agreement with BHX, LLC for the lease of 61,000 square feet of office space at 784 Memorial Drive, Cambridge, Massachusetts during the three months ended September 30, 2014.

 

     Payments Due by Period  
     (in thousands)  

Contractual Obligations

   Total      2015      2016-2019      2020
and beyond
 

784 lease

   $ 21,485       $ 1,362       $ 8,176       $ 11,947   

We are obligated to pay to Takeda up to $5 million in remaining success-based milestones for the development of two distinct product candidates, and up to $450 million in success-based milestones for the approval and commercialization of two distinct products. Because the achievement of these milestones had not occurred as of September 30, 2014, such contingencies have not been recorded in our financial statements.

Amounts related to contingent milestone payments are not considered contractual obligations as they are contingent on the successful achievement of certain development, regulatory approval and commercial milestones, which may not be achieved.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our interest income is sensitive to changes in the general level of U.S. interest rates, particularly since a significant portion of our investments are in money market funds, corporate obligations, and U.S. government-sponsored enterprise obligations. We do not enter into investments for trading or speculative purposes. Our cash is deposited in and invested through highly rated financial institutions in the United States. Our marketable securities are subject to interest rate risk and will fall in value if market interest rates increase.

A hypothetical 100 basis point increase in interest rates would result in an approximate $0.2 million decrease in the fair value of our investments as of September 30, 2014, as compared to an approximate $0.8 million decrease as of December 31, 2013. We have the ability to hold our fixed income investments until maturity and, therefore, we do not expect our operating results or cash flows to be affected to any significant degree by the effect of a change in market interest rates on our investments.

 

Item 4. Controls and Procedures

Our management, with the participation of our principal executive and financial officers, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2014. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 as amended, or 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

 

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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 September 30, 2014, our principal executive and financial officers concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the fiscal quarter ended September 30, 2014 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II. OTHER INFORMATION

 

Item 1A. Risk Factors

You should carefully consider the following risk factors, in addition to other information included in this quarterly report on Form 10-Q, in evaluating Infinity and our business. If any of the following risks occur, our business, financial condition and operating results could be materially adversely affected. These risk factors restate and supersede the risk factors set forth under the heading “Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2013.

Risks Related to Our Stage of Development as a Company

Our results to date do not guarantee that any of our product candidates will be safe or effective, or receive regulatory approval.

The risk of failure of our current product candidates is high. To date, the data supporting our clinical development strategy for our product candidates are derived solely from laboratory and preclinical studies and limited early-to-mid-stage clinical trials. Later clinical trials may not yield data consistent with earlier clinical trials, as was the case with our randomized Phase 2 clinical trial of retaspimycin hydrochloride in combination with docetaxel in patients with non-small cell lung cancer, which did not yield results consistent with results obtained from an earlier Phase 1b study. Similarly, clinical responses seen in patients enrolled at early stages of a clinical trial may not be replicated in patients enrolled in that trial at a later time. In addition, adverse events not observed in early clinical trials may be seen for the first time in later studies, or adverse events observed in a small number of patients in early trials may be seen in a greater number of patients in later studies and have greater statistical significance than previously anticipated. In the event that our clinical trials do not yield data consistent with earlier experience, it may be necessary for us to change our development strategy or abandon development of that product candidate, either of which could result in delays, additional costs and a decrease in our stock price. It is impossible to predict when or if any of our product candidates will prove safe or effective in humans or receive regulatory approval. These product candidates may not demonstrate in patients the chemical and pharmacological properties ascribed to them in laboratory studies or early-stage clinical trials, and they may interact with human biological systems or other drugs in unforeseen, ineffective or harmful ways. If we are unable to discover or successfully develop drugs that are safe and effective in humans, we will not have a viable business.

We have a history of operating losses, expect to incur significant and increasing operating losses in the future, may never become profitable, or if we become profitable we may not remain profitable.

We have a limited operating history for you to evaluate our business. We have no approved products and have generated no product revenue from sales. We have primarily incurred operating losses. As of September 30, 2014, we had an accumulated deficit of $427 million. We expect to continue to spend significant resources to fund the research and development of duvelisib and our other product candidates. While we may have net income in future periods as the result of non-recurring collaboration revenue, we expect to incur substantial operating losses over the next several years as our clinical trial and drug manufacturing activities increase. In addition, in connection with seeking and possibly obtaining regulatory approval of any of our product candidates, we expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution. As a result, we expect that our accumulated deficit will also increase significantly.

Our product candidates are in varying stages of preclinical and clinical development and may never be approved for sale or generate any revenue. We will not be able to generate product revenue unless and until one of our product candidates successfully completes clinical trials and receives regulatory approval. Since even our most advanced product candidate requires substantial additional clinical development, we do not expect to receive revenue from our product candidates for several years, if ever. Even if we eventually generate revenues, we may never be profitable, and if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.

We may be unable to raise the substantial additional capital that we will need to sustain our operations.

We will need additional funds to support our planned operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or commercialization efforts. Our need to raise additional funds may be accelerated if our research and development expenses exceed our current expectation, if we acquire a third party, or if we acquire or license rights to additional product candidates or new technologies from one or more third parties. Our need to raise additional funds may also be accelerated for other reasons, including without limitation if:

 

    our product candidates require more extensive clinical or preclinical testing than we currently expect;

 

    we advance our product candidates into clinical trials for more indications than we currently expect;

 

    we advance more of our product candidates than expected into costly later stage clinical trials;

 

    we advance more preclinical product candidates than expected into early stage clinical trials;

 

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    we acquire additional business, technologies, products or product candidates;

 

    the cost of acquiring raw materials for, and of manufacturing, our product candidates is higher than anticipated;

 

    the cost or quantity required of comparator drugs used in clinical studies increases

 

    we are required, or consider it advisable, to acquire or license intellectual property rights from one or more third parties; or

 

    we experience a loss in our investments due to general market conditions or other reasons.

We may seek to satisfy our need for additional funds by drawing down funds under the debt facility agreement we entered into with affiliates of Deerfield Management Company, L.P., or Deerfield, in February 2014, as amended on September 22, 2014, which we refer to as the Facility Agreement. Deerfield agreed to loan to us up to $50 million subject to the terms and conditions of the Facility Agreement. Our ability to draw down under the agreement is subject to various customary conditions; however, there is no assurance that we will be able to satisfy these conditions and draw down any funds. If we draw down under the Facility Agreement, we will be required to grant to Deerfield a security interest in substantially all of our assets including intellectual property, issue additional warrants to Deerfield, and repay any amounts borrowed together with interest accruing at a rate of 7.95% per annum no later than December 15, 2019. Any amounts drawn under the Facility Agreement may become immediately due and payable upon customary events of default or the consummation of certain major transactions, in which case Deerfield would have the right to require us to repay 100% of the principal amount of the loan, together with any accrued and unpaid interest thereon, plus any applicable additional amounts relating to a prepayment or termination. Principal and interest under the Facility Agreement may be paid in cash or freely tradable shares of common stock at our election, subject to specified conditions at any time of conversion. There is no assurance that the conditions to our ability to repay the loan in shares of our common stock would be satisfied at the time that any outstanding principal and interest under the loan is due, in which case we would be obligated to repay the loan in cash, or that events permitting acceleration of the loan will not occur, in which event we would be required to repay any outstanding principal and interest sooner than anticipated.

We may also seek additional funding through public or private financings of equity or debt securities, but such financing may not be available on acceptable terms, or at all. In addition, the terms of such financings may result in, among other things, dilution for stockholders or the incurrence of indebtedness that may impact our ability to make capital expenditures or incur additional debt as would be the case if we decided to draw down under the Facility Agreement with Deerfield. We may also seek additional funds through arrangements with collaborators or other third parties, or through project financing. These arrangements would generally require us to relinquish or encumber rights to some of our technologies or product candidates, and we may not be able to enter into such arrangements on acceptable terms, if at all. If we are unable to obtain additional funding on a timely basis, we may be required to curtail or terminate some or all of our product development programs or to scale back, suspend or terminate our business operations.

If our strategic alliance with AbbVie, or any future alliance we may enter into, is unsuccessful, our operations may be negatively impacted.

We have a strategic collaboration with AbbVie Inc., or AbbVie, to research, develop and jointly commercialize products containing or comprised of duvelisib, which we refer to as Duvelisib Products, in oncology indications. We refer to this agreement as the AbbVie Agreement. Pursuant to the AbbVie Agreement, AbbVie has committed to providing substantial funding, as well as significant capabilities in development, marketing and sales. However, we may not be able to maintain our alliance with AbbVie or any other future alliance partner if, for example, development or approval of duvelisib or other product candidates is delayed or sales of Duvelisib Products or other products are disappointing. Further, AbbVie may be the only alliance we are able to successfully execute, making us overly dependent on the success of duvelisib in oncology indications and therefore particularly vulnerable if duvelisib or the alliance with AbbVie fails, as discussed in the next risk factor.

If an alliance partner terminates or fails to perform its obligations under agreements with us, the development and commercialization of our product candidates could be delayed or terminated.

The success of a strategic alliance, whether with AbbVie or any future partner, is largely dependent on the resources, efforts, technology and skills brought to such alliance by such partner. The benefits of such alliances will be reduced or eliminated if any such partner does not devote sufficient time and resources to its alliance arrangements with us, without which we may not realize the potential commercial benefits of the arrangement, and our results of operations may be adversely affected. In addition, if such partner were to breach or terminate its arrangements with us or fail to maintain the financial resources necessary to continue financing its portion of development, manufacturing, and commercialization costs, as applicable, we may not have the financial resources or capabilities necessary to continue development and commercialization of the product candidate on our own. Consequently, the development and commercialization of the affected product candidate could be delayed, curtailed or terminated, and we may find it difficult to attract a new alliance partner for such product candidate. Disputes and difficulties in these types of relationships are common, often due to priorities changing over time, conflicting priorities or conflicting interests. Merger and acquisition activity may exacerbate these conflicts.

 

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As is the case with our strategic collaboration with AbbVie, much of the potential revenue from alliances consists of payments contingent upon the achievement of specified milestones and royalties payable on sales of any successfully developed drugs. Any such contingent revenue will depend upon our, and our alliance partner’s, ability to successfully develop, launch, market and sell new drugs. In some cases, we will not be involved in some or all of these processes, and we will depend entirely on our alliance partners. Under the AbbVie Agreement, for instance, we have granted AbbVie exclusive licenses to commercialize Duvelisib Products outside the United States. AbbVie or any future alliance partner may fail to develop or effectively commercialize duvelisib or future drug products if it:

 

    decides not to devote the necessary resources because of internal constraints, such as limited personnel with the requisite scientific expertise, limited cash resources or specialized equipment limitations, or the belief that other product candidates may have a higher likelihood of obtaining regulatory approval or may potentially generate a greater return on investment;

 

    does not have sufficient resources necessary to carry the product candidate through clinical development, regulatory approval and commercialization; or

 

    cannot obtain the necessary regulatory approvals.

If AbbVie or any future alliance partner fails to develop or effectively commercialize our product candidates, we may not be able to develop and commercialize that product candidate independently, and our financial condition and operations would be negatively impacted.

If we are not able to attract and retain key personnel and advisors, we may not be able to operate our business successfully.

We are highly dependent on our executive leadership team. All of these individuals are employees-at-will, which means that neither Infinity nor the employee is obligated to a fixed term of service and that the employment relationship may be terminated by either Infinity or the employee at any time, without notice and whether or not cause or good reason exists for such termination. The loss of the services of any of these individuals might impede the achievement of our research, development and commercialization objectives. We do not maintain “key person” insurance on any of our employees.

Recruiting and retaining qualified scientific and business personnel is also critical to our success. We may not be able to attract or retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. This competition is particularly intense near our headquarters in Cambridge, Massachusetts. We also experience competition for the hiring of scientific personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development strategy. Our consultants and advisors may be employed by other entities, have commitments under consulting or advisory contracts with third parties that limit their availability to us, or both.

Our competitors and potential competitors may develop products that make ours less attractive or obsolete.

In building our product development pipeline, we have intentionally pursued targets with applicability across multiple therapeutic areas and indications. This approach gives us several product opportunities in oncology and inflammatory diseases, which are highly competitive and rapidly changing segments of the pharmaceutical industry. Many large pharmaceutical and biotechnology companies, academic institutions, governmental agencies and other public and private research organizations are pursuing the development of novel drugs that target various diseases in these segments. We currently face, and expect to continue to face, intense and increasing competition as new products enter the market and advanced technologies become available. Moreover, there are a number of large pharmaceutical companies currently marketing and selling products in these segments including Bristol-Myers Squibb Company; the Roche Group and its subsidiary Genentech; Novartis AG; Pfizer, Inc.; and Johnson & Johnson. In addition to currently approved drugs, there are a significant number of drugs that are currently under development and may become available in the future for the treatment of various forms of cancer and inflammatory diseases.

We are also aware of a number of companies developing product candidates or selling products directed to the same biological targets that our own product candidates are designed to inhibit. Specifically:

 

    we believe that Gilead Sciences, Inc.; Amgen Inc.; Rhizen Pharmaceuticals S.A.; and TG Therapeutics, Inc., are conducting clinical trials of drugs that target the delta and/or gamma isoforms of phosphoinositide-3-kinase, or PI3K, which is the target of duvelisib; and

 

    many companies are developing product candidates or selling products directed to disease targets such as Bruton’s Tyrosine Kinase (or BTK), Janus Kinase (or JAK), Spleen Tyrosine Kinase (or Syk), B-cell lymphoma 2 (or Bcl-2) or other isoforms of PI3K in the fields of hematology-oncology and inflammation, including in the specific diseases for which we are currently developing duvelisib, or for which we may develop duvelisib, IPI-443 or other PI3K inhibitors in the future, including Pharmacyclics, Inc. through its collaboration with Janssen Biotech; Incyte Corporation; Ono Pharmaceutical Group; Vertex Pharmaceuticals Incorporated; Acerta Pharma BV; Celgene Corporation; AbbVie, Inc.; and Bayer AG.

 

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Many of our competitors have:

 

    significantly greater financial, technical and human resources than we have, and may be better equipped to discover, develop, manufacture and commercialize product candidates than we are;

 

    more extensive experience in preclinical testing and clinical trials, obtaining regulatory approvals and manufacturing and marketing products than we do; and/or

 

    product candidates that have been approved, such as ibrutinib, a BTK inhibitor being developed and commercialized by Pharmacyclics, Inc. for the treatment of people with mantle cell lymphoma or chronic lymphocytic leukemia, or CLL, are in later-stage clinical development than our own product candidates.

Our competitors may commence and complete clinical testing of their product candidates, obtain regulatory approvals and begin commercialization of their products sooner than we and/or our strategic alliance partners may for our own product candidates. These competitive products may have superior safety or efficacy, have more attractive pharmacologic properties, or may be manufactured less expensively than our future products. If we are unable to compete effectively against these companies on the basis of safety, efficacy or cost, then we may not be able to commercialize our future products or achieve a competitive position in the market. This would adversely affect our ability to generate revenues.

We may encounter difficulties in managing organizational change, which could adversely affect our operations.

Our ability to effectively manage organizational changes and growth, depends upon the continual improvement of our processes and procedures and the preservation of our corporate culture. Under the AbbVie Agreement, we and AbbVie have created a governance structure, including committees and working groups to manage the development, manufacturing and commercialization responsibilities for the Duvelisib Products. Generally, we and AbbVie must mutually agree on decisions, although in specified circumstances either we or AbbVie would be able to break a deadlock. Any future alliance may also require implementation of a similarly complex governing structure. We may not be able to implement improvements in an efficient or timely manner or to maintain our corporate culture during periods of organizational change. If we do not meet these challenges, we may be unable to take advantage of market opportunities, execute our business strategies or respond to competitive pressures, which in turn may give rise to inefficiencies that would increase our losses or delay our programs.

We may undertake strategic acquisitions in the future, and any difficulties from integrating acquired businesses, products, product candidates and technologies could adversely affect our business and our stock price.

We may acquire additional businesses, products, product candidates, or technologies that complement or augment our existing business. We may not be able to integrate any acquired business, product, product candidate or technology successfully or operate any acquired business profitably. Integrating any newly acquired business, product, product candidate, or technology could be expensive and time-consuming. Integration efforts often place a significant strain on managerial, operational and financial resources and could prove to be more difficult or expensive than we expect. The diversion of the attention of our management to, and any delay or difficulties encountered in connection with, any future acquisitions we may consummate could result in the disruption of our ongoing business or inconsistencies in standards, controls, procedures and policies that could adversely affect our ability to maintain relationships with customers, suppliers, collaborators, employees and others with whom we have business dealings. We may need to raise additional funds through public or private debt or equity financings to acquire any businesses, products, product candidates, or technologies which may result in, among other things, dilution for stockholders or the incurrence of indebtedness.

As part of our efforts to acquire businesses, products, product candidates and technologies or to enter into other significant transactions, we conduct business, legal and financial due diligence in an effort to identify and evaluate material risks involved in the transaction. We will also need to make certain assumptions regarding acquired product candidates, including, among other things, development costs, the likelihood of receiving regulatory approval and the market for such product candidates. If we are unsuccessful in identifying or evaluating all such risks or our assumptions prove to be incorrect, we might not realize some or all of the intended benefits of the transaction. If we fail to realize intended benefits from acquisitions we may consummate in the future, our business and financial results could be adversely affected.

In addition, we will likely incur significant expenses in connection with our efforts, if any, to consummate acquisitions. These expenses may include fees and expenses for investment bankers, attorneys, accountants and other advisers in connection with our efforts and could be incurred whether or not an acquisition is consummated. Even if we consummate a particular acquisition, we may incur as part of such acquisition substantial closure costs associated with, among other things, elimination of duplicate operations and facilities. In such case, the incurrence of these costs could adversely affect our financial results for particular quarterly or annual periods.

 

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Our investments are subject to risks that may cause losses and affect the liquidity of these investments.

As of September 30, 2014, we had approximately $379.5 million in cash, cash equivalents and available-for-sale securities. We historically have invested these amounts in money market funds, corporate obligations, U.S. government-sponsored enterprise obligations, U.S. Treasury securities and mortgage-backed securities meeting the criteria of our investment policy, which prioritizes the preservation of our capital. Corporate obligations may include obligations issued by corporations in countries other than the United States, including some issues that have not been guaranteed by governments and government agencies. Our investments are subject to general credit, liquidity, market and interest rate risks and instability in the global financial markets. We may realize losses in the fair value of these investments or a complete loss of these investments. In addition, should our investments cease paying or reduce the amount of interest paid to us, our interest income would suffer. These market risks associated with our investment portfolio may have a material adverse effect on our financial results and the availability of cash to fund our operations.

The estimates and judgments we make, or the assumptions on which we rely, in preparing our condensed consolidated financial statements could prove inaccurate.

Our condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of our assets, liabilities, revenues and expenses. Such estimates and judgments include those related to revenue recognition, accrued expenses, assumptions in the valuation of stock-based compensation and income taxes. We base our estimates and judgments on historical experience, facts and circumstances known to us and on various assumptions that we believe to be reasonable under the circumstances. These estimates and judgments, or the assumptions underlying them, may change over time or prove inaccurate. If this is the case, we may be required to restate our financial statements as we did in 2011, which could in turn subject us to securities class action litigation. Defending against such potential litigation relating to a restatement of our financial statements would be expensive and would require significant attention and resources of our management. Moreover, our insurance to cover our obligations with respect to the ultimate resolution of any such litigation may be inadequate. As a result of these factors, any such potential litigation could have a material adverse effect on our financial results and cause our stock price to decline.

Under our strategic alliance termination agreements, Mundipharma and Purdue continue to have the right to audit research and development expenses incurred by us during the term of our former strategic alliance to verify the research and development funding amounts previously paid by Mundipharma and Purdue and have, in the past, exercised such rights. If, as a result of any audit, it is determined that Mundipharma and Purdue have overpaid research and development expenses, we will be required to refund the amount of such overpayment, plus interest, and if such amount is material it could adversely impact our financial results and available cash and require us to restate prior period revenue.

If we are not able to maintain effective internal controls under Section 404 of the Sarbanes-Oxley Act, our business and stock price could be adversely affected.

Section 404 of the Sarbanes-Oxley Act of 2002 requires us, on an annual basis, to review and evaluate our internal controls and requires our independent auditors to attest to the effectiveness of our internal controls. Any failure by us to maintain the effectiveness of our internal controls in accordance with the requirements of Section 404 of the Sarbanes-Oxley Act, as such requirements exist today or may be modified, supplemented or amended in the future, could have a material adverse effect on our business, operating results and stock price.

Risks Related to the Development and Commercialization of Our Product Candidates

All of our product candidates remain subject to clinical testing and regulatory approval. This process is highly uncertain, and we may never be able to obtain marketing approval for any of our product candidates.

To date, we have not obtained approval from the U.S. Food and Drug Administration, or FDA, or any foreign regulatory authority to market or sell any of our product candidates. Our product candidates are subject to extensive governmental regulations relating to development, clinical trials, manufacturing and commercialization. Rigorous preclinical testing and clinical trials and an extensive regulatory approval process are required in the United States and in many foreign jurisdictions prior to the commercial sale of medicinal products like our product candidates. For example, we are evaluating duvelisib, the lead compound in our PI3K inhibitor program, in all phases of clinical development, and we anticipate initiating multiple additional trials of duvelisib in 2014. If any of these trials or other trials of our product candidates are successful, we may need to conduct further clinical trials and will need to apply for regulatory approval before we may market or sell any of our future products. Satisfaction of these and other regulatory

 

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requirements is costly, time consuming, uncertain and subject to unanticipated delays. It is possible that none of the product candidates we are developing, or may in the future develop, either alone or in collaboration with strategic alliance partners, will obtain marketing approval. We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including approval by the FDA and comparable foreign regulatory agencies. The time required to complete clinical trials and for regulatory review by the FDA and other countries’ regulatory agencies is uncertain and typically takes many years. Some of our product candidates may be eligible for the FDA’s programs that are designed to facilitate the development and expedite the review of certain drugs, but we cannot provide any assurance that any of our product candidates will qualify for one or more of these programs. Even if a product candidate qualifies for one or more of these programs, the FDA may later decide that the product candidate no longer meets the conditions for qualification.

Our analysis of data obtained from preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. We may also encounter unanticipated delays or increased costs due to changes in government regulation from future legislation or administrative action or changes in FDA and other regulatory policy during the period of product candidate development, clinical trials and FDA and other regulatory review.

Any delay in obtaining or failure to obtain required approvals could materially adversely affect our ability to generate revenues from the particular product candidate. Furthermore, the uses for which any regulatory authority may grant approval to market a product may be limited, thus placing constraints on the manner in which we may market the product and curtailing its market potential.

Our product candidates must undergo rigorous clinical trials prior to receipt of regulatory approval. Any problems in these clinical trials could delay or prevent commercialization of our product candidates.

We cannot predict whether we will encounter problems with any of our ongoing or planned clinical trials that will cause us or regulatory authorities to delay, suspend, or discontinue clinical trials or to delay the analysis of data from ongoing clinical trials. Any of the following could delay or disrupt the clinical development of our product candidates:

 

    unfavorable results of discussions with the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;

 

    delays in receiving, or the inability to obtain, required approvals from institutional review boards or other reviewing entities at clinical sites selected for participation in our clinical trials;

 

    delays in enrolling patients into clinical trials;

 

    a lower than anticipated retention rate of patients in clinical trials;

 

    the need to repeat or discontinue clinical trials as a result of inconclusive or negative results or unforeseen complications in testing or because the results of later trials may not confirm positive results from earlier preclinical studies or clinical trials;

 

    inadequate supply, delays in distribution or deficient quality of, or inability to purchase or manufacture drug product, comparator drugs or other materials necessary to conduct our clinical trials;

 

    unfavorable FDA or other foreign regulatory inspection and review of a clinical trial site or records of any clinical or preclinical investigation;

 

    serious and unexpected drug-related side effects experienced by participants in our clinical trials, which may occur even if they were not observed in earlier trials or only observed in a limited number of participants;

 

    a finding that the trial participants are being exposed to unacceptable health risks;

 

    the placement by the FDA or a foreign regulatory authority of a clinical hold on a trial; or

 

    any restrictions on, or post-approval commitments with regard to, any regulatory approval we ultimately obtain that render the product candidate not commercially viable.

We may suspend, or the FDA or other applicable regulatory authorities may require us to suspend, clinical trials of a product candidate at any time if we or they believe the patients participating in such clinical trials, or in independent third party clinical trials for drugs based on similar technologies, are being exposed to unacceptable health risks or for other reasons.

The delay, suspension or discontinuation of any of our clinical trials, or a delay in the analysis of clinical data for our product candidates, for any of the foregoing reasons, could adversely affect our efforts to obtain regulatory approval for and to commercialize our product candidates, increase our operating expenses and have a material adverse effect on our financial results.

 

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Our inability to enroll sufficient numbers of patients in our clinical trials, or any delays in patient enrollment, can result in increased costs and longer development periods for our product candidates.

Clinical trials require sufficient patient enrollment, which is a function of many factors, including:

 

    the size of the patient population;

 

    the nature of the trial protocol, including eligibility criteria for the trial;

 

    the number of clinical trial sites and the proximity of patients to those sites;

 

    the commitment of clinical investigators to identify eligible patients; and

 

    competing studies or trials.

Additionally, the availability of safe and effective treatments for the relevant disease being studied may impact patient enrollment in our clinical trials. For example, Pharmacyclics, Inc. has received approval to manufacture and market ibrutinib, a BTK inhibitor for the treatment of CLL, an indication in which we are currently evaluating duvelisib in a Phase 3 clinical trial.

Our failure to enroll patients in a clinical trial could delay the initiation or completion of the clinical trial beyond current expectations. In addition, the FDA or other foreign regulatory authorities could require us to conduct clinical trials with a larger number of patients than has been projected for any of our product candidates. As a result of these factors, we may not be able to enroll a sufficient number of patients in a timely or cost-effective manner.

Furthermore, enrolled patients may drop out of a clinical trial, which could impair the validity or statistical significance of the clinical trial. A number of factors can influence the patient discontinuation rate, including, but not limited to:

 

    the inclusion of a placebo arm in a trial;

 

    possible inactivity or low activity of the product candidate being tested at one or more of the dose levels being tested;

 

    the occurrence of adverse side effects, whether or not related to the product candidate; and

 

    the availability of numerous alternative treatment options, including clinical trials evaluating competing product candidates, that may induce patients to discontinue their participation in the trial.

A delay in our clinical trial activities could adversely affect our efforts to obtain regulatory approval for and to commercialize our product candidates, increase our operating expenses, and have a material adverse effect on our financial results.

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

There has been limited success to date industry-wide in developing companion diagnostics. To be successful in developing a companion diagnostic, we will need to address a number of scientific, technical and logistical challenges. Companion diagnostics are subject to regulation by the FDA and similar regulatory authorities outside the United States as medical devices and require separate regulatory approval prior to commercialization. We have limited experience in the development of diagnostics and may not be successful in developing appropriate diagnostics to pair with any of our product candidates that receive marketing approval. Given our limited experience in developing diagnostics, we expect to rely, in part, on third parties for their design and manufacture. If we, or any third parties that we engage to assist us, are unable to successfully develop companion diagnostics for our product candidates or experience delays in doing so, the development of our product candidates may be adversely affected, our product candidates may not receive marketing approval and we may not realize the full commercial potential of any product candidates that receive marketing approval.

We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily.

We rely on third parties such as contract research organizations, medical institutions and external investigators to enroll qualified patients, conduct our clinical trials and provide services in connection with such clinical trials, and we intend to rely on these and other similar entities in the future. Our reliance on these third parties for clinical development activities reduces our control over these activities. Accordingly, these third party contractors may not complete activities on schedule, or may not conduct our clinical trials in accordance with regulatory requirements or the trial design. If these third parties do not successfully carry out their contractual obligations or meet expected deadlines, we may be required to replace them. Replacing a third party contractor may result in a delay of the affected trial and unplanned costs. If this were to occur, our efforts to obtain regulatory approval for and to commercialize our product candidates may be delayed.

 

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In addition, we are responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocol for the trial. The FDA requires us to comply with certain standards, referred to as good clinical practices, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. If any of our trial investigators or third party contractors does not comply with good clinical practices, we may not be able to use the data and reported results from the trial. If this noncompliance were to occur, our efforts to obtain regulatory approval for and to commercialize our product candidates may be delayed.

 

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Manufacturing difficulties could delay or preclude commercialization of our product candidates and substantially increase our expenses.

Our product candidates require precise, high quality manufacturing. The third party manufacturers on which we rely may not be able to comply with the FDA’s current good manufacturing practices, or cGMPs, and other applicable government regulations and corresponding foreign standards. These regulations govern manufacturing processes and procedures and the implementation and operation of systems to control and assure the quality of products. The FDA and foreign regulatory authorities may, at any time, audit or inspect a manufacturing facility to ensure compliance with cGMPs and other quality standards. Any failure by our contract manufacturers to achieve and maintain high manufacturing and quality control standards could result in the inability of our product candidates to be released for use in one or more countries. In addition, such a failure could result in, among other things, patient injury or death, product liability claims, penalties or other monetary sanctions, the failure of regulatory authorities to grant marketing approval of our product candidates, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and/or criminal prosecution, any of which could significantly and adversely affect supply of our product candidates and seriously hurt our business.

Contract manufacturers may also encounter difficulties involving production yields or delays in performing their services. We do not have control over third party manufacturers’ performance and compliance with applicable regulations and standards. If, for any reason, our manufacturers cannot perform as agreed, we may be unable to replace such third party manufacturers in a timely manner, and the production of our product candidates would be interrupted, resulting in delays in clinical trials and additional costs. Switching manufacturers may be difficult because the number of potential manufacturers is limited and, depending on the type of material manufactured at the contract facility, the change in contract manufacturer must be submitted to and/or approved by the FDA and comparable regulatory authorities outside of the United States. In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production of our product candidates after receipt of regulatory approval. It may be difficult or impossible for us to find a replacement manufacturer on acceptable terms quickly, or at all.

To date, our product candidates have been manufactured for preclinical testing and clinical trials primarily by third party manufacturers. If the FDA or other regulatory agencies approve any of our product candidates for commercial sale, we expect that we would continue to rely, at least initially, on third party manufacturers to produce commercial quantities of our approved product candidates. These manufacturers may not be able to successfully increase the manufacturing capacity for any approved product candidates in a timely or economical manner, or at all. Significant scale-up of manufacturing might entail changes in the manufacturing process that have to be submitted to or approved by the FDA or other regulatory agencies. If contract manufacturers engaged by us are unable to successfully increase the manufacturing capacity for a product candidate, or we are unable to establish our own manufacturing capabilities, the commercial launch of any approved products may be delayed or there may be a shortage in supply.

We may not be able to successfully transition responsibilities for the manufacturing of Duvelisib Products to AbbVie.

We may be unsuccessful in transferring the responsibility to manufacture Duvelisib Products to AbbVie. The transition process may be more complicated, time consuming and expensive than originally intended, which may negatively affect the supply of Duvelisib Products. Should the strategic collaboration with AbbVie terminate, the process of transitioning manufacturing back to us may be time consuming and expensive, and we may become unable to maintain an adequate supply of Duvelisib Products worldwide.

We currently have limited marketing, sales and distribution experience and capabilities and are dependent upon AbbVie to commercialize Duvelisib Products outside the United States.

We and AbbVie share the obligations to commercialize Duvelisib Products in oncology in the United States and AbbVie has the sole obligation to commercialize Duvelisib Products in oncology outside the United States. To successfully commercialize Duvelisib Products, we will need to, and we intend to, establish adequate marketing, sales and distribution capabilities for commercialization in the United States. We may not successfully establish these capabilities or have sufficient resources to do so. If we do not establish adequate marketing, sales and distribution capabilities, our ability to successfully commercialize any product candidates that we successfully develop will be adversely affected, as will our financial results. Even if we do develop such capabilities, we will compete with other companies that have more experienced and well-funded marketing, sales and distribution operations.

If physicians and patients do not accept our future drugs, we may not be able to generate significant revenues from product sales.

Even if any of our product candidates obtains regulatory approval, that product may not gain market acceptance among physicians, patients and the medical community for a variety of reasons including:

 

    timing of our receipt of any marketing approvals, the terms of any such approvals and the countries in which any such approvals are obtained;

 

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    timing of market introduction of competitive products;

 

    lower demonstrated clinical safety or efficacy, or less convenient route of administration, compared to competitive products;

 

    lack of cost-effectiveness;

 

    lack of reimbursement from managed care plans and other third-party payors;

 

    inconvenient or difficult administration;

 

    prevalence and severity of side effects;

 

    potential advantages of alternative treatment methods;

 

    safety concerns with similar products marketed by others;

 

    the reluctance of the target population to try new therapies and of physicians to prescribe those therapies;

 

    the lack of success of our physician education programs; and

 

    ineffective sales, marketing and distribution support.

If any of our approved drugs fails to achieve market acceptance, we would not be able to generate significant revenue from those drugs, which may adversely impact our ability to become profitable.

Even if we receive regulatory approvals for marketing our product candidates, we could lose our regulatory approvals and our business would be adversely affected if we, our strategic alliance partners, or our contract manufacturers fail to comply with continuing regulatory requirements.

The FDA and other regulatory agencies continue to review products even after they receive initial approval. If we receive approval to commercialize any of our product candidates, the manufacturing, marketing and sale of these drugs will be subject to continuing regulation, including compliance with quality systems regulations, cGMPs, adverse event requirements and prohibitions on promoting a product for unapproved uses. Enforcement actions resulting from our failure to comply with government and regulatory requirements could result in fines, suspension of approvals, withdrawal of approvals, product recalls, product seizures, mandatory operating restrictions, criminal prosecution, civil penalties and other actions that could impair the manufacturing, marketing and sale of our product candidates and our ability to conduct our business.

If our product candidates exhibit harmful side effects after approval, our regulatory approvals could be revoked or otherwise negatively impacted, and we could become subject to costly and damaging product liability claims.

Even if we receive regulatory approval for any of our product candidates, we will have tested them in only a small number of patients and over a limited period of time during our clinical trials. If our applications for marketing are approved and more patients begin to use our products, or patients use our products for a longer period of time, new risks and side effects associated with our products may be discovered or previously observed risks and side effects may become more prevalent and/or clinically significant. In addition, supplemental clinical trials that may be conducted on a drug following its initial approval may produce findings that are inconsistent with the trial results previously submitted to regulatory authorities. As a result, regulatory authorities may revoke their approvals, or we may be required to conduct additional clinical trials, make changes in labeling of our product, reformulate our product or make changes and obtain new approvals for our and our suppliers’ manufacturing facilities. We also might have to withdraw or recall our products from the marketplace. Any safety concerns with respect to a product may also result in a significant drop in the potential sales of that product, damage to our reputation in the marketplace, or result in our becoming subject to lawsuits, including class actions. Any of these results could decrease or prevent any sales of our approved product or substantially increase the costs and expenses of commercializing and marketing our product.

We are subject to uncertainty relating to reimbursement policies that could hinder or prevent the commercial success of our product candidates.

Our ability to commercialize any future products successfully will depend in part on the coverage and reimbursement levels set by governmental authorities, private health insurers and other third-party payors. As a threshold for coverage and reimbursement, third-party payors in the U.S. generally require that product candidates have been approved for marketing by the FDA. Third-party payors also are increasingly challenging the effectiveness of and prices charged for medical products and services. We may not obtain adequate third-party coverage or reimbursement for our future products, or we may be required to sell our future products at prices that are below our expectations.

 

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We expect that private insurers will consider the efficacy, cost effectiveness and safety of our future products in determining whether, and at what level, to approve reimbursement for our future products. Obtaining these approvals can be a time consuming and expensive process. Our business would be materially adversely affected if we do not receive approval for reimbursement of our future products from private insurers on a timely or satisfactory basis. Our business could also be adversely affected if private insurers, including managed care organizations, the Medicare and Medicaid programs or other reimbursing bodies or payors limit the indications for which our future products will be reimbursed to a smaller set than we believe our future products are effective in treating.

In some foreign countries, particularly Canada and European Union member states, the pricing of prescription pharmaceuticals is subject to strict governmental control. In these countries, pricing negotiations with governmental authorities can take six to 12 months or longer after the receipt of regulatory approval and product launch. To obtain favorable reimbursement for the indications sought or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our products to other available therapies. If reimbursement for our products is unavailable in any country in which reimbursement is sought or is limited in scope or amount, or if pricing is set at unsatisfactory levels, our business would be materially harmed.

We expect to experience pricing pressures in connection with the sale of our future products, if any, due to the potential healthcare reforms discussed below, as well as the trend toward programs aimed at reducing health care costs, the increasing influence of health maintenance organizations and additional legislative proposals.

Healthcare reform measures could hinder or prevent our future products’ commercial success.

The U.S. government and other governments have shown significant interest in pursuing healthcare reform, as evidenced by the passing of the Patient Protection and Affordable Care Act, or PPACA, and the Health Care and Education Reconciliation Act. These healthcare reform laws have the effect of increasing the number of individuals who receive health insurance coverage and closing a gap in drug coverage under Medicare Part D as established under the Medicare Prescription Drug Improvement Act of 2003. Each of these reforms could potentially increase our future revenue from any of our product candidates that are approved for sale. The law, however, also implements cost containment measures that could adversely affect our future revenue. These measures include increased drug rebates under Medicaid for brand name prescription drugs and extension of these rebates to Medicaid managed care. The legislation also extends certain discounted pricing on outpatient drugs to children’s hospitals, critical access hospitals and rural health centers. This expansion reduces the amount of reimbursement received for drugs purchased by these newly covered entities.

Additional provisions of the health care reform law may negatively affect our future revenue and prospects for profitability. Along with other pharmaceutical manufacturers and importers of brand name prescription drugs, we would be assessed a fee based on our proportionate share of sales of brand name prescription drugs to certain government programs, including Medicare and Medicaid. As part of the health care reform law’s provisions closing a funding gap that currently exists in the Medicare Part D prescription drug program (commonly known as the “donut hole”), we will also be required to provide a 50% discount on brand name prescription drugs sold to beneficiaries who fall within the donut hole.

In the aftermath of the healthcare reform law, private health insurers and managed care plans are likely to continue challenging the prices charged for medical products and services. These cost-control initiatives could decrease the price we might establish for any of our future products, which would result in lower product revenue or royalties payable to us.

In addition, in some foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the health care system in ways that could affect our ability to sell our future products profitably. These proposed reforms could result in reduced reimbursement rates for any of our future products, which would adversely affect our business strategy, operations and financial results.

Our business could be harmed if we are unable to comply with applicable “fraud and abuse” and other laws and regulations where our product candidates may ultimately be sold.

As our pipeline of product candidates matures, we are becoming increasingly subject to extensive and complex laws and regulations, including but not limited to healthcare “fraud and abuse” and patient privacy laws and regulations by both the federal government and the states in which we conduct our business. These laws and regulations include:

 

    the federal healthcare program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

 

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    federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent, and which may apply to entities like us which provide coding and billing advice to customers;

 

    the federal Health Insurance Portability and Accountability Act of 1996, which prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information;

 

    the Federal Food, Drug, and Cosmetic Act, which, among other things, strictly regulates drug marketing, prohibits manufacturers from marketing drugs for off-label use and regulates the distribution of drug samples; and

 

    state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.

If our operations are found to be in violation of any of the laws described above or any governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations. Any penalties, damages, fines, curtailment or restructuring of our operations could adversely affect our financial results. We are developing and implementing a corporate compliance program designed to ensure that we will market and sell any future products that we successfully develop from our product candidates in compliance with all applicable laws and regulations, but we cannot guarantee that this program will protect us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such 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.

Risks Related to Our Field

We may have significant product liability exposure that may harm our business and our reputation.

We face exposure to significant product liability or other claims if any of our product candidates is alleged to have caused harm. These risks are inherent in the testing, manufacturing and marketing of human medicinal products. Although we do not currently commercialize any products, claims could be made against us based on the use of our product candidates in clinical trials. We currently have clinical trial insurance and will seek to obtain product liability insurance prior to the commercial launch of any of our product candidates. Our insurance may not, however, provide adequate coverage against potential liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable to maintain current amounts of insurance coverage or obtain additional or sufficient insurance at a reasonable cost. If we are sued for any injury caused by our product candidates or future products, our liability could exceed our insurance coverage and our total assets, and we would need to divert management attention to our defense. Claims against us, regardless of their merit or potential outcome, may also generate negative publicity or hurt our ability to recruit investigators and patients to our clinical trials, obtain physician acceptance of our future products, or expand our business.

We work with hazardous materials that may expose us to liability.

Our activities involve the controlled storage, use and disposal of hazardous materials, including infectious agents; corrosive, explosive and flammable chemicals; and various radioactive compounds. We are subject to certain federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. We incur significant costs to comply with these laws and regulations. In addition, we cannot eliminate the risk of accidental contamination or injury from these materials. In the event of an accident, regulatory authorities may curtail our use of these materials, and we could be liable for any civil damages that result. These damages may exceed our financial resources or insurance coverage and may seriously harm our business. Additionally, an accident could damage, or force us to shut down, our operations.

Security breaches may disrupt our operations and harm our operating results.

Our network security and data recovery measures may not be adequate to protect against computer viruses, break-ins and similar disruptions from unauthorized tampering with our computer systems. The misappropriation, theft, sabotage or any other type of security breach with respect to any of our proprietary and confidential information that is electronically stored, including research or clinical data, could have a material adverse impact on our business, operating results and financial condition. Additionally, any break-in or trespass of our facilities that results in the misappropriation, theft, sabotage or any other type of security breach with respect to our proprietary and confidential information, including research or clinical data, or that results in damage to our research and development equipment and assets, could have a material adverse impact on our business, operating results and financial condition.

 

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Risks Related to Intellectual Property

Our success depends substantially upon our ability to obtain and maintain intellectual property protection for our product candidates.

We own or hold exclusive licenses to a number of U.S. and foreign patents and patent applications directed to our product candidates. Our success depends on our ability to obtain patent protection both in the United States and in other countries for our product candidates, their methods of manufacture and their methods of use. Our ability to protect our product candidates from unauthorized or infringing use by third parties depends substantially on our ability to obtain and enforce our patents.

Due to evolving legal standards relating to the patentability, validity and enforceability of patents covering pharmaceutical inventions and molecular diagnostics and the claim scope of these patents, our ability to obtain and enforce patents that may issue from any pending or future patent applications is uncertain and involves complex legal, scientific and factual questions. The standards that the United States Patent and Trademark Office, or PTO, and its foreign counterparts use to grant patents are not always applied predictably or uniformly and are subject to change. To date, no consistent policy has emerged regarding the breadth of claims allowed in pharmaceutical or molecular diagnostics patents. Thus, we cannot guarantee that any patents will issue from any pending or future patent applications owned by or licensed to us. Even if patents do issue, we cannot guarantee that the claims of these patents will be held valid or enforceable by a court of law, will provide us with any significant protection against competitive products or will afford us a commercial advantage over competitive products.

The U.S. Congress passed the Leahy-Smith America Invents Act, or the America Invents Act, which became effective in March 2013. The America Invents Act reforms United States patent law in part by changing the standard for patent approval for certain patents from a “first to invent” standard to a “first to file” standard and developing a post-grant review system. This new law changes United States patent law in a way that may severely weaken our ability to obtain patent protection in the United States. Additionally, recent judicial decisions establishing new case law and a reinterpretation of past case law, as well as regulatory initiatives, may make it more difficult for us to protect our intellectual property.

If we do not obtain adequate intellectual property protection for our products in the United States, competitors could duplicate them without repeating the extensive testing that we will have been required to undertake to obtain approval by the FDA. Regardless of any patent protection, under the current statutory framework, the FDA is prohibited by law from approving any generic version of any of our products for up to five years after it has approved our product. Upon the expiration of that period, or if that time period is altered, the FDA could approve a generic version of our product unless we have patent protection sufficient for us to block that generic version. Without sufficient patent protection, the applicant for a generic version of our product would only be required to conduct a relatively inexpensive study to show that its product is bioequivalent to our product and would not have to repeat the studies that we conducted to demonstrate that the product is safe and effective.

In the absence of adequate patent protection in other countries, competitors may similarly be able to obtain regulatory approval in those countries for products that duplicate our products. The laws of some foreign jurisdictions do not protect intellectual property rights to the same extent as in the United States. Many companies have encountered significant difficulties in protecting and defending such rights in foreign jurisdictions. Some of our development efforts may be performed in China, India and other countries outside of the United States through third party contractors. We may not be able to monitor and assess intellectual property developed by these contractors effectively; therefore, we may not be able to appropriately protect this intellectual property and could lose valuable intellectual property rights. In addition, the legal protection afforded to inventors and owners of intellectual property in countries outside of the United States may not be as protective of intellectual property rights as in the United States, and we may, therefore, be unable to acquire and protect intellectual property developed by these contractors to the same extent as if these development activities were being conducted in the United States. If we encounter difficulties in protecting our intellectual property rights in foreign jurisdictions, our business prospects could be substantially harmed.

In addition, we rely on intellectual property assignment agreements with our strategic alliance partners, vendors, employees, consultants, clinical investigators, scientific advisors and other collaborators to grant us ownership of new intellectual property that is developed by them. These agreements may not result in the effective assignment to us of that intellectual property. As a result, our ownership of key intellectual property could be compromised.

Patent interference, opposition or similar proceedings relating to our intellectual property portfolio are costly, and an unfavorable outcome could prevent us from commercializing our product candidates.

Patent applications in the United States are maintained in confidence for up to 18 months after their filing. In some cases, however, patent applications remain confidential in the PTO for the entire time prior to issuance as a U.S. patent. Similarly, publication of discoveries in the scientific or patent literature often lags behind actual discoveries. Consequently, we cannot be certain that we were the first to invent, or the first to file patent applications on, our product candidates or their therapeutic use. In the event

 

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that a third party has also filed a U.S. patent application relating to our product candidates or a similar invention, we may have to participate in interference proceedings declared by the PTO or the third party to determine priority of invention in the United States. An adverse decision in an interference proceeding may result in the loss of rights under a patent or patent application. In addition, the cost of interference proceedings could be substantial.

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.

The PTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. There are situations in which non-compliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If we fail to comply with these requirements, competitors might be able to enter the market earlier than would otherwise have been the case, which could decrease our revenue from that product.

Claims by third parties of intellectual property infringement are costly and distracting, and could deprive us of valuable rights we need to develop or commercialize our product candidates.

Our commercial success will depend on whether there are third party patents or other intellectual property relevant to our potential products that may block or hinder our ability to develop and commercialize our product candidates. We may not have identified all U.S. and foreign patents or published applications that may adversely affect our business either by blocking our ability to manufacture or commercialize our drugs or by covering similar technologies that adversely affect the applicable market. In addition, we may undertake research and development with respect to product candidates, even when we are aware of third party patents that may be relevant to such product candidates, on the basis that we may challenge or license such patents. There are no assurances that such licenses will be available on commercially reasonable terms, or at all. If such licenses are not available, we may become subject to patent litigation and, while we cannot predict the outcome of any litigation, it may be expensive and time consuming. If we are unsuccessful in litigation concerning patents owned by third parties, we may be precluded from selling our products.

While we are not currently aware of any litigation or third party claims of intellectual property infringement related to our product candidates, the biopharmaceutical industry is characterized by extensive litigation regarding patents and other intellectual property rights. Other parties may obtain patents and claim that the use of our technologies infringes these patents or that we are employing their proprietary technology without authorization. We could incur substantial costs and diversion of management and technical personnel in defending against any claims that the manufacture and sale of our potential products or use of our technologies infringes any patents, or defending against any claim that we are employing any proprietary technology without authorization. The outcome of patent litigation is subject to uncertainties that cannot be adequately quantified in advance, including the demeanor and credibility of witnesses and the identity of the adverse party, especially in pharmaceutical patent cases that may turn on the testimony of experts as to technical facts upon which experts may reasonably disagree. In the event of a successful claim of infringement against us, we may be required to:

 

    pay substantial damages;

 

    stop developing, manufacturing and/or commercializing the infringing product candidates or approved products;

 

    develop non-infringing product candidates, technologies and methods; and

 

    obtain one or more licenses from other parties, which could result in our paying substantial royalties or the granting of cross-licenses to our technologies.

If any of the foregoing were to occur, we may be unable to commercialize the affected products, or we may elect to cease certain of our business operations, either of which could severely harm our business.

We may undertake infringement or other legal proceedings against third parties, causing us to spend substantial resources on litigation and exposing our own intellectual property portfolio to challenge.

Competitors may infringe our patents. To prevent infringement or unauthorized use, we may need to file infringement suits, which are expensive and time-consuming. In an infringement proceeding, a court may decide that one or more of our patents is invalid, unenforceable, or both. Even if the validity of our patents is upheld, a court may refuse to stop the other party from using the technology at issue on the ground that the other party’s activities are not covered by our patents. In this case, third parties may be able to use our patented technology without paying licensing fees or royalties. Policing unauthorized use of our intellectual property is difficult, and we may not be able to prevent misappropriation of our proprietary rights, particularly in countries where the laws may not protect such rights as fully as in the United States. In addition, third parties may affirmatively challenge our rights to, or the scope or validity of, our patent rights.

 

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Confidentiality agreements may not adequately prevent disclosure of trade secrets and other proprietary information.

To protect our proprietary technology, we rely in part on confidentiality agreements with our vendors, strategic alliance partners, employees, consultants, scientific advisors, clinical investigators and other collaborators. We generally require each of these individuals and entities to execute a confidentiality agreement at the commencement of a relationship with us. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure or misuse of confidential information or other breaches of the agreements.

In addition, we may rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or obtainable. Trade secrets are, however, difficult to protect. Others may independently discover our trade secrets and proprietary information, and in such case we could not assert any trade secret rights against such party. Enforcing a claim that a party illegally obtained and is using our trade secrets is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, courts outside of the United States may be less willing to protect trade secrets. Costly and time-consuming litigation could be necessary to seek to enforce and determine the scope of our proprietary rights and could result in a diversion of management’s attention, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.

If we fail to obtain necessary or useful licenses to intellectual property, we could encounter substantial delays in the research, development and commercialization of our product candidates.

We may decide to license third party technology that we deem necessary or useful for our business. We may not be able to obtain these licenses at a reasonable cost, or at all. If we do not obtain necessary licenses, we could encounter substantial delays in developing and commercializing our product candidates while we attempt to develop alternative technologies, methods and product candidates, which we may not be able to accomplish. Furthermore, if we fail to comply with our obligations under our third party license agreements, we could lose license rights that are important to our business. For example, if we fail to use diligent efforts to develop and commercialize products licensed under our amended and restated development and license agreement with Takeda, we could lose our license rights under that agreement, including rights to duvelisib.

Risks Associated with Our Common Stock

Our common stock may have a volatile trading price and low trading volume.

The market price of our common stock has been and could continue to be subject to significant fluctuations. Some of the factors that may cause the market price of our common stock to fluctuate include:

 

    the results of our current and any future clinical trials of our product candidates;

 

    the results of preclinical studies and planned clinical trials of our discovery-stage programs;

 

    product portfolio decisions resulting in the delay or termination of our product development programs;

 

    future sales of, and the trading volume in, our common stock;

 

    our entry into key agreements, including those related to the acquisition or in-licensing of new programs, or the termination of key agreements, including our collaboration and license agreement with AbbVie, our amended and restated development and license agreement with Takeda or our Facility Agreement with Deerfield;

 

    the results and timing of regulatory reviews relating to the approval of our product candidates;

 

    the initiation of, material developments in, or conclusion of litigation, including but not limited to litigation to enforce or defend any of our intellectual property rights or to defend product liability claims;

 

    the failure of any of our product candidates, if approved, to achieve commercial success;

 

    the results of clinical trials conducted by others on drugs that would compete with our product candidates;

 

    the regulatory approval of drugs that would compete with our product candidates;

 

    issues in manufacturing our product candidates or any approved products;

 

    the loss of key employees;

 

    changes in estimates or recommendations, or publication of inaccurate or unfavorable research about our business, by securities analysts who cover our common stock;

 

    future financings through the issuance of equity or debt securities or otherwise;

 

    the drawing down of funds under our Facility Agreement with Deerfield;

 

    healthcare reform measures, including changes in the structure of healthcare payment systems;

 

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    our cash position and period-to-period fluctuations in our financial results; and

 

    general and industry-specific economic and/or capital market conditions.

Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of our common stock.

In the past, when the market price of a stock has been volatile, as our stock price may be, holders of that stock have occasionally brought securities class action litigation against the company that issued the stock. If any of our stockholders were to bring a lawsuit of this type against us, even if the lawsuit is without merit, negative publicity could be generated, and we could incur substantial costs defending the lawsuit. A stockholder lawsuit could also divert the time and attention of our management.

We do not anticipate paying cash dividends, so you must rely on stock price appreciation for any return on your investment.

We anticipate retaining any future earnings for reinvestment in our research and development programs. Therefore, we do not anticipate paying cash dividends in the future. As a result, only appreciation of the price of our common stock will provide a return to stockholders. Investors seeking cash dividends should not invest in our common stock.

Anti-takeover provisions in our organizational documents and Delaware law may make an acquisition of us difficult.

We are incorporated in Delaware. Anti-takeover provisions of Delaware law and our organizational documents may make a change in control more difficult. Also, under Delaware law, our board of directors may adopt additional anti-takeover measures. For example, our charter authorizes our board of directors to issue up to 1,000,000 shares of undesignated preferred stock and to determine the terms of those shares of stock without any further action by our stockholders. If our board of directors exercises this power, it could be more difficult for a third party to acquire a majority of our outstanding voting stock. Our charter and bylaws also contain provisions limiting the ability of stockholders to call special meetings of stockholders.

Our stock incentive plan generally permits our board of directors to provide for acceleration of vesting of options granted under that plan in the event of certain transactions that result in a change of control. If our board of directors uses its authority to accelerate vesting of options, this action could make an acquisition more costly, and it could prevent an acquisition from going forward.

Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law statute, which generally prohibits a person who owns in excess of 15% of our outstanding voting stock from engaging in a transaction with us for a period of three years after the date on which such person acquired in excess of 15% of our outstanding voting common stock, unless the transaction is approved by our board of directors and holders of at least two-thirds of our outstanding voting stock, excluding shares held by such person. The prohibition against such transactions does not apply if, among other things, prior to the time that such person became an interested stockholder, our board of directors approved the transaction in which such person acquired 15% or more of our outstanding voting stock. The existence of the foregoing provisions could limit the price that investors might be willing to pay in the future for shares of our common stock.

Our executive officers, directors and major shareholders may be able to exert significant control over the company, which may make an acquisition of us difficult.

To our knowledge, based on the number of shares of our common stock outstanding on September 30, 2014, stockholders holding 5% or more of our common stock, as well as our executive officers, directors, and their respective affiliates, owned in the aggregate approximately 55% of our common stock. These stockholders have the ability to influence our company through this ownership position. For example, as a result of this concentration of ownership, these stockholders, if acting together, may have the ability to affect the outcome of matters submitted to our stockholders for approval, including the election and removal of directors, changes to our equity compensation plans and any merger or similar transaction. This concentration of ownership may, therefore, harm the market price of our common stock by:

 

    delaying, deferring or preventing a change in control of Infinity;

 

    impeding a merger, consolidation, takeover or other business combination involving Infinity; or

 

    discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of Infinity.

 

45


Table of Contents
Item 5. Other Information

780/790 Memorial Drive Lease Amendment

On November 6, 2014, we entered into a Seventh Amendment to Lease, or the Lease Amendment, by and between us and ARE-770/784/790 Memorial Drive, LLC, or the Landlord, which amends that Lease Agreement originally dated July 2, 2002, as amended to date, which we refer to as the Original Lease. We shall refer to the Original Lease together with the Lease Amendment as the Memorial Drive Lease. We shall refer to the area rented under the Memorial Drive Lease as the Premises.

Under the Lease Amendment: (i) the Premises consist of 54,861 square feet, of which 3,861 square feet are located at 790 Memorial Drive, or the 790 Premises; we surrendered 13,159 square feet of the previously leased 17,020 square feet at the 790 Premises; (ii) we have extended the base term of the Memorial Drive Lease through March 31, 2025; and (iii) we have two separate five-year options to extend the term of the Memorial Drive Lease to 2035 on the same terms and conditions (other than with respect to base rent or any work letter). The Memorial Drive Lease provides that we shall continue to pay the base rent as provided in the Original Lease until January 31, 2016. The base rent shall then increase to $69.00 per square foot of the Premises on February 1, 2016 and again to $70.00 per square foot of the Premises on February 1, 2018. The Memorial Drive Lease provides that no base rent for the Premises shall be due (i) for the period commencing on February 1, 2015 through July 31, 2015, (ii) for the period commencing on February 1, 2016 through February 29, 2016, (iii) for the period commencing on February 1, 2017 through February 28, 2017, and (iv) for the period commencing on February 1, 2018 through February 28, 2018. We have also received a base building allowance of $1,097,220, or $20.00 per square foot, for the design and construction of capital improvements to the 780 Premises and a tenant improvement allowance of $1,920,135, or $35.00 per square foot, for the design and construction of additional alterations to the Premises.

The foregoing summary description of the Memorial Drive Lease does not purport to be complete and is qualified in its entirety by reference to the Memorial Drive Lease, which is attached as Exhibits 10.5 hereto and incorporated herein by reference.

 

Item 6. Exhibits

(a) Exhibits.

The exhibits listed in the Exhibit Index are included in this report.

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) 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.

 

  INFINITY PHARMACEUTICALS, INC.
Date: November 10, 2014   By:   /s/ L AWRENCE E. B LOCH , M.D., J.D.
    Lawrence E. Bloch, M.D., J.D.
    Executive Vice President, Chief Financial Officer and Chief Business Officer
    (Principal Financial Officer &
Principal Accounting Officer)

 

46


Table of Contents

EXHIBIT INDEX

 

          Incorporated by Reference  

Exhibit No.

  

Description

   Form    SEC
Filing
date
   Exhibit
Number
   Filed
with
this
10-Q
 
  10.1    Amendment to Amended and Restated Development and License Agreement, dated as of dated July 29, 2014, by and between Infinity Pharmaceuticals, Inc. and Intellikine LLC.               X   
  10.2*    Collaboration and License Agreement, dated as of September 2, 2014, between Infinity Pharmaceuticals, Inc. and AbbVie Inc.               X   
  10.3    First Amendment to Facility Agreement, dated as of September 22, 2014, between Infinity Pharmaceuticals, Inc. and Deerfield Private Design Fund II, L.P., Deerfield Private Design International II, L.P., Deerfield Partners, L.P., and Deerfield International Master Fund, L.P.               X   
  10.4    Lease Agreement, dated as of September 25, 2014, between Infinity Pharmaceuticals, Inc. and BHX, LLC, as trustee of 784 Realty Trust.               X   
  10.5    Seventh Amendment to Lease, dated as of November 6, 2014, between Infinity Pharmaceuticals, Inc. and ARE-770/784/790 Memorial Drive, LLC.               X   
  31.1    Certification of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended. Filed herewith.               X   
  31.2    Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended. Filed herewith.               X   
  32.1    Certification of principal executive officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Filed herewith.               X   
  32.2    Certification of principal financial officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Filed herewith.               X   
101    The following materials from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, formatted in XBRL (eXtensible Business Reporting Language): (i) the Condensed Consolidated Balance Sheets, (ii) the Condensed Consolidated Statements of Operations and Comprehensive Loss, (iii) the Condensed Consolidated Statements of Cash Flows, and (iv) Notes to Condensed Consolidated Financial Statements. Filed herewith.               X   

 

* Confidential treatment has been requested as to certain portions, which portions have been filed separately with the Securities and Exchange Commission.

 

47

Exhibit 10.1

AMENDMENT TO

AMENDED AND RESTATED DEVELOPMENT AND LICENSE AGREEMENT

This Amendment to Amended and Restated Development and License Agreement (“ Amendment ”) is made as of this 29th day of July, 2014 (the “ Amendment Effective Date ”) by and between Intellikine LLC, a limited liability company organized and existing under the laws of the State of Delaware and successor to Intellikine, Inc. (“ Intellikine ”), and Infinity Pharmaceuticals, Inc., a company organized and existing under the laws of the State of Delaware (“ Infinity ”). Intellikine and Infinity are each referred to individually as a “ Party ” and together as the “ Parties ”.

RECITALS

WHEREAS, Intellikine and Infinity are parties to the Amended and Restated Development and License Agreement, effective as of December 24, 2012 (the “ Effective Date ”, and such agreement, the “ Agreement ”);

WHEREAS, in consideration of the payment of the Option Fee (as defined below), Intellikine wishes to grant to Infinity an option to terminate its obligation to pay Royalties (as defined in the Agreement) with respect to the IPI-145 Product (as defined below) in oncology Indications (the “Option” );

WHEREAS, the Parties wish to amend the Agreement, in accordance with Section 18.8 thereof, as set forth below;

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

 

1. Definitions .

 

  1.1 IPI-145 Product ” means a Product which is, or which contains or comprises, the compound known as IPI-145 (also known as INK1197 or IPI145) or any of its various chemical forms, including acids, bases, salts, metabolites, esters, isomers, enantiomers, pro-drug forms, hydrates, solvates, polymorphs and degradants thereof in crystal, powder or other form.

 

  1.2 All terms used, but not defined, in this Amendment shall have the meaning set forth in the Agreement.

 

2. Option Fee & Exercise Fee .

 

2.1 In consideration for Intellikine granting the Option to Infinity, Infinity shall pay to Intellikine an option fee equal to five million dollars (US$5,000,000) (the “Option Fee” ) within thirty (30) days of the Amendment Effective Date.

 

1


2.2 Subject to the proviso of this Section 2.2, the Option is exercisable at any time, at Infinity’s sole discretion, upon delivery of written notice to Intellikine no less than five (5) Business Days in advance of Infinity’s payment of an exercise fee equal to fifty two million five hundred thousand dollars (US$52,500,000) (the “Exercise Fee” ); provided that the Exercise Fee must be delivered to Intellikine (or its designee) on or before March 31, 2015. If the Exercise Fee is not delivered on or before March 31, 2015, the Option shall expire and Infinity’s obligation to pay Royalties with respect to the IPI-145 Product shall remain unchanged and in full force and effect.

 

3. Royalty Termination . Upon payment of the Option Fee and the Exercise Fee described in Section 2 above, Infinity’s obligation to pay Royalties with respect to the IPI-145 Product(s) in oncology Indications shall terminate. Notwithstanding the foregoing, (a) the Royalty Term(s) for the IPI-145 Product(s) will be unaffected by Infinity’s exercise of the Option and will, for the avoidance of doubt, continue, on a Royalty-Bearing Product-by-Royalty-Bearing Product and country-by-country basis, except for Infinity’s obligation to pay Royalties with respect to the IPI-145 Product(s) in oncology Indications, (b) the IPI-145 Product(s) will continue to constitute a Royalty-Bearing Product(s), as defined in Article 1 of the Agreement, and for all other purposes in the Agreement, except for Infinity’s obligation to pay Royalties with respect to the IPI-145 Product(s) in oncology Indications, and (c) the provisions of Section 9.2(b) shall continue to apply to the IPI-145 Product(s), on a Royalty-Bearing Product-by-Royalty-Bearing Product and country-by-country basis.

 

4. Press Release . In the event that either Party wishes to issue a press release or other public statement relating to the terms and conditions of this Amendment, it shall comply with the obligations set forth in Section 13.2 of the Agreement with respect thereto.

 

5. Entire Agreement/Amendments .

(a) Except as amended by this Amendment, the Agreement and the Parties’ respective rights and obligations thereunder, shall remain in full force and effect. Without limiting the foregoing, and except as explicitly set forth herein, this Amendment does not modify, amend or have any effect on either Party’s rights or obligations under the Agreement, including, as applicable, with respect to (a) the IPI-145 Product(s) in non-oncology Indications, (b) Milestone Payments with respect to the IPI-145 Product(s), (c) any other Licensed Compound and/or Product regardless of Indication, (d) obligations to use Diligent Efforts with respect to Licensed Compounds and/or Products, including with respect to the IPI-145 Product(s), or (e) any other obligations, financial or otherwise, under the Agreement.

(b) After the Amendment Effective Date, every reference in the Agreement to the “Agreement” shall mean the Agreement as amended by this Amendment.

 

6. Counterparts . This Amendment may be executed in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Signatures provided by facsimile transmission or in Adobe TM Portable Document Format (PDF) sent by electronic mail shall be deemed to be original signatures.

 

2


[THIS SPACE INTENTIONALLY LEFT BLANK]

 

3


IN WITNESS WHEREOF, the Parties intending to be bound have caused this Amendment to be executed by their duly authorized representatives

 

SIGNED for and on behalf of   )    

/s/ Anna Protopapas

INTELLIKINE LLC   )     Anna Protopapas
  )     President
SIGNED for and on behalf of   )    

/s/ Adelene Q. Perkins

INFINITY PHARMACEUTICALS, INC.   )     Adelene Q. Perkins
  )     President and Chief Executive Officer

 

4

Exhibit 10.2

EXECUTION VERSION

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

COLLABORATION AND LICENSE AGREEMENT

BY AND BETWEEN

INFINITY PHARMACEUTICALS, INC.

AND

ABBVIE INC.


TABLE OF CONTENTS

 

ARTICLE 1. DEFINITIONS      1   
ARTICLE 2. MANAGEMENT OF COLLABORATIVE ACTIVITIES      28   

2.1.

  Overview of Collaboration      28   

2.2.

  Joint Development Committee      29   

2.3.

  Joint Commercialization Committee      31   

2.4.

  Medical Affairs Committee      32   

2.5.

  Working Groups      33   

2.6.

  Membership      34   

2.7.

  Meetings of the Committees and Working Groups      35   

2.8.

  Discontinuation of Participation on a Committee      35   

2.9.

  Decision-Making      35   

2.10.

  Alliance Managers      38   
ARTICLE 3. LICENSE GRANTS      38   

3.1.

  Infinity Grants      38   

3.2.

  AbbVie Grants      40   

3.3.

  Provision of Information      41   

3.4.

  Joint Patent Rights      41   

3.5.

  Blocking Third Party Intellectual Property      41   

3.6.

  Sublicensing and Subcontracting      43   

3.7.

  Exclusivity Covenants      44   

3.8.

  Reservation of Rights      45   
ARTICLE 4. DEVELOPMENT      46   

4.1.

  GDP; Amendments; Development Responsibilities      46   

4.2.

  Medical Affairs Activities      49   

4.3.

  Development Efforts; Manner of Performance; Reports      51   

4.4.

  Regulatory Submissions and Regulatory Approvals      53   

4.5.

  Pharmacovigilance      54   

4.6.

  Costs of Joint Development      55   

4.7.

  Development Records      57   
ARTICLE 5. COMMERCIALIZATION      57   

5.1.

  Commercialization Efforts      57   

5.2.

  Manner of Performance      58   

5.3.

  Commercialization Plans      59   

 

i


5.4.

  Global Branding Strategy      60   

5.5.

  Commercialization Responsibilities for the US Territory      60   

5.6.

  Commercialization in the Ex-US Territory      62   

5.7.

  Sales Representatives      62   

5.8.

  Co-Promotion in the United States      62   
ARTICLE 6. MANUFACTURE AND SUPPLY      63   

6.1.

  Manufacture      63   

6.2.

  Manufacturing Working Group      64   
ARTICLE 7. FINANCIAL PROVISIONS      64   

7.1.

  Upfront and Milestone Payments      64   

7.2.

  Net Profit or Loss      64   

7.3.

  Royalties      65   

7.4.

  Reconciliation of Costs Incurred in or for the Ex-US Territory      68   

7.5.

  Financial Audits      68   

7.6.

  Tax Matters      69   

7.7.

  Currency Exchange      71   

7.8.

  Blocked Payments      72   

7.9.

  Late Payments      72   
ARTICLE 8. INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS      72   

8.1.

  Ownership of Inventions      72   

8.2.

  Prosecution and Maintenance of Patent Rights      74   

8.3.

  Third Party Infringement      76   

8.4.

  Patent Term Extensions      79   

8.5.

  Patent Marking      79   

8.6.

  Orange Book Listings      79   

8.7.

  Trademarks      80   
ARTICLE 9. CONFIDENTIALITY AND PUBLICITY      82   

9.1.

  Confidential Information      82   

9.2.

  Residual Knowledge Exception      83   

9.3.

  Publicity      83   

9.4.

  Publications      84   

9.5.

  Public Filing of this Agreement      85   

 

ii


ARTICLE 10. REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS      85   

10.1.

  Mutual Representations and Warranties      85   

10.2.

  Additional Representations and Warranties of Infinity      86   

10.3.

  Additional Representations and Warranties of AbbVie      89   

10.4.

  No Debarment      89   

10.5.

  No Warranties      90   

10.6.

  Covenants with Respect to Infinity Third Party Agreements      90   

10.7.

  Covenants with Respect to AbbVie Third Party Agreements      92   

10.8.

  Insurance      93   
ARTICLE 11. INDEMNIFICATION      94   

11.1.

  General Indemnification By Infinity      94   

11.2.

  General Indemnification By AbbVie      94   

11.3.

  Claims for General Indemnification      94   

11.4.

  Conduct of Product Liability Actions      95   
ARTICLE 12. TERM AND TERMINATION      96   

12.1.

  Term      96   

12.2.

  Early Termination      96   

12.3.

  Effects of Termination      99   
ARTICLE 13. ALTERNATIVE DISPUTE RESOLUTION      105   
ARTICLE 14. MISCELLANEOUS      109   

14.1.

  Change of Control of the Parties      109   

14.2.

  Assignment; Successors      109   

14.3.

  Export Control      110   

14.4.

  Choice of Law      110   

14.5.

  Notices      111   

14.6.

  Severability      111   

14.7.

  Integration      112   

14.8.

  English Language      112   

14.9.

  Waivers and Amendments      112   

14.10.

  Independent Contractors; No Agency      112   

14.11.

  Execution in Counterparts; Facsimile Signatures      112   

14.12.

  No Consequential or Punitive Damages      113   

14.13.

  Performance by Affiliates      113   

14.14.

  Force Majeure      113   

14.15.

  No Third Party Beneficiary Rights      114   

14.16.

  Non-exclusive Remedy      114   

 

iii


14.17.

  Interpretation      114   

14.18.

  Further Assurances      115   

14.19.

  Ambiguities; No Presumption      115   

14.20.

  Records Generally      115   

LIST OF SCHEDULES

 

Schedule 1.40    Exclusivity Compounds
Schedule A    [**] Description
Schedule 3.5.1    Non-Royalty Payments under Existing Infinity Third Party Agreements
Schedule 4.6.1    Pre-Execution Date Development Costs
Schedule 7    Financial Terms
Schedule 10.2.7    Litigation
  
LIST OF EXHIBITS
  
Exhibit A    Financial Exhibit
Exhibit B    Infinity Patent Rights
Exhibit C    Global Development Plan
Exhibit D    IPI-145
Exhibit E    Press Release
Exhibit F    AbbVie Combination Compound

 

iv


COLLABORATION AND LICENSE AGREEMENT

This Collaboration and License Agreement (this “ Agreement ”) is made and effective as of the 2 nd day of September, 2014 (the “ Execution Date ”) by and between Infinity Pharmaceuticals, Inc., a Delaware corporation, with offices at 780 Memorial Drive, Cambridge, MA 02139, USA (“ Infinity ”) and AbbVie Inc., a Delaware corporation, with offices at 1 North Waukegan Road, North Chicago, IL 60064 (“ AbbVie ”).

INTRODUCTION

WHEREAS, Infinity has certain rights to and is developing the Licensed Compounds and Products (each as defined below);

WHEREAS, Infinity and AbbVie believe that a collaboration and license arrangement between the Parties regarding the Products would be desirable and that participation of both Parties in this arrangement would be of economic benefit to both Parties; and

WHEREAS, Infinity and AbbVie therefore desire to provide for the development, manufacture and commercialization of the Products on and subject to the terms and conditions set forth herein.

NOW, THEREFORE, for and in consideration of the mutual covenants contained herein, Infinity and AbbVie hereby agree as follows:

ARTICLE 1.

DEFINITIONS

As used in this Agreement, the following terms shall have the meanings set forth below:

1.1. “ AbbVie Combination Compound ” means the compound further described in Exhibit F.

1.2. “ AbbVie Intellectual Property ” means AbbVie Know-How and AbbVie Patent Rights, collectively.

1.3. “ AbbVie Know-How ” means all Know-How Controlled by AbbVie or any of its Affiliates, as of the Execution Date or during the Term, that is not generally known and is necessary or useful for the Development, Manufacture or Commercialization of any Licensed Compound or Product in the Field, including the rights of AbbVie or its Affiliates in AbbVie Sole Inventions and Joint Inventions, but excluding any Know-How to the extent Covered by published AbbVie Patent Rights.

1.4. “ AbbVie Patent Rights ” means all Patent Rights Controlled by AbbVie or any of its Affiliates, as of the Execution Date or during the Term, that are necessary or useful for the Development, Manufacture or Commercialization of any Licensed Compound or Product in the Field, including the rights of AbbVie or its Affiliates in Joint Patent Rights and in Patent Rights covering AbbVie Sole Inventions.

 

1


1.5. “ AbbVie Third Party Agreements ” means (a) any Third Party agreement existing prior to or as of the Effective Date pursuant to which AbbVie Controls, or with the consent of the applicable Third Party would Control, any Know-How included, or that would be included, in AbbVie Know-How or Patent Rights included, or that would be included, in AbbVie Patent Rights, and (b) any Third Party agreement entered into by AbbVie pursuant to Section 3.5; each such agreement as it may be amended from time to time.

1.6. “ AbbVie Withholding Tax Action ” means any action taken by AbbVie, an AbbVie Affiliate, or successor that both (a) shifts to a foreign Affiliate of AbbVie, its successor or Sublicensee any obligation to make a payment to Infinity under this Agreement and (b) results in a net increase of Withholding Tax on such payment.

1.7. “ Accounting Standards ” means, with respect to a Person, generally accepted accounting principles as practiced in the United States or applicable international standards followed by such Person.

1.8. “ Action ” means any claim, action, cause of action or suit (whether in contract or tort or otherwise), litigation (whether at law or in equity, whether civil or criminal), controversy, assessment, arbitration, investigation, hearing, charge, complaint, demand, notice or proceeding of, to, from, by or before any Governmental Authority.

1.9. “ Adverse Event ” means any adverse event associated with the use of a drug in humans, whether or not considered drug related, including (a) an adverse event occurring in the use of a drug product in a clinical investigation, (b) an adverse event occurring in the course of the use of a drug product in professional practice, (c) an adverse event occurring from drug overdose whether accidental or intentional, (d) an adverse event occurring from drug abuse, (e) an adverse event occurring from drug withdrawal or (f) and any failure of expected pharmacological action.

1.10. “ Affiliate ” means with respect to any Person, any Person controlling, controlled by or under common control with such first Person. For purposes of this Section 1.10, “ control ” means (a) direct or indirect ownership of more than fifty percent (50%) of the stock or shares having the right to vote for the election of directors of such Person (or if the jurisdiction where such Person is domiciled prohibits foreign ownership of such entity, the maximum foreign ownership interest permitted under such Laws; provided , that such ownership interest provides actual control over such Person), (b) status as a general partner in any partnership, or (c) the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such Person, whether through the ownership of voting securities, by contract or otherwise.

1.11. “ Blocking Third Party Intellectual Property ” means, with respect to a Licensed Compound or Product in any country, Patent Rights or Know-How in such country owned or controlled by a Third Party (but not then included in Infinity Intellectual Property or AbbVie Intellectual Property) that Cover (with respect to Patent Rights), or are necessary or, where explicitly provided in this Agreement, useful to Develop, Manufacture or Commercialize (with respect to such Know-How owned or Controlled by a Third Party), such Licensed Compound or Product in such country, to the extent such Development, Manufacture or Commercialization is contemplated in such country.

 

2


1.12. “ Blocking Third Party Intellectual Property Costs ” means Out-of-Pocket Costs, comprising upfront payments, milestones, royalties, and any portion of other license fees or other payments arising out of the Development, Manufacturing or Commercialization of a Product and paid to a Third Party who owns or controls Blocking Third Party Intellectual Property to license or acquire the relevant Patent Rights or Know-How for the Development, Manufacture or Commercialization of a Product in the Field in accordance with Section 3.5.

1.13. “ Business Day ” means any day other than a Saturday or a Sunday on which the banks in New York, New York are open for business.

1.14. “ Calendar Quarter ” means each of the three (3) month periods ending on March 31, June 30, September 30, and December 31 of any Calendar Year, or the applicable portion of such period.

1.15. “ Calendar Year ” means each twelve (12) month period commencing on January 1, and ending on December 31, or the applicable portion of such period; provided , that the first Calendar Year commences on the Effective Date and ends on December 31, 2014.

1.16. “ Change of Control ” means, with respect to a Party, any of the following events occurring after the Effective Date:

(a) any “person” or “group” (as such terms are defined below) (a) is or becomes the “beneficial owner” (as defined below), directly or indirectly, of shares of capital stock or other interests (including partnership interests) of such Party then outstanding and normally entitled (without regard to the occurrence of any contingency) to vote in the election of the directors, managers or similar supervisory positions (“ Voting Stock ”) of such Party representing fifty percent (50%) or more of the total voting power of all outstanding classes of Voting Stock of such Party or (b) has the power, directly or indirectly, to elect a majority of the members of the Party’s board of directors, or similar governing body (“ Board of Directors ”); or

(b) such Party enters into a merger, consolidation or similar transaction with another Person (whether or not such Party is the surviving entity), and as a result of such merger, consolidation or similar transaction (a) the members of the Board of Directors of such Party immediately prior to such transaction constitute less than a majority of the members of the Board of Directors of such Party or such surviving Person immediately following such transaction or (b) the Persons that beneficially owned, directly or indirectly, the shares of Voting Stock of such Party immediately prior to such transaction cease to beneficially own, directly or indirectly, shares of Voting Stock of such Party representing at least a majority of the total voting power of all outstanding classes of Voting Stock of the surviving Person in substantially the same proportions as their ownership of Voting Stock of such Party immediately prior to such transaction; or

(c) such Party sells or transfers to any Third Party, in one (1) or more related transactions, properties or assets representing all or substantially all of such Party’s consolidated total assets to which this Agreement relates; or

(d) the holders of capital stock of such Party approve a plan or proposal for the liquidation or dissolution of such Party.

 

3


For the purpose of this definition of Change of Control: (a) “person” and “group” have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934 (the “ Exchange Act ”) and the term “group” includes any group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d-5(b)(1) under the said Act; (b) a “beneficial owner” shall be determined in accordance with Rule 13d-3 under the aforesaid Act; and (c) the terms “beneficially owned” and “beneficially own” shall have meanings correlative to that of “beneficial owner.”

1.17. “ Clinical Investigation Laws ” means Laws relating to human clinical investigations, including 21 C.F.R. Parts 50, 54, 56 and 312, and GCP.

1.18. “ Clinical Study ” means any Phase I Clinical Study, Phase II Clinical Study, Phase III Clinical Study, Phase IIIb Clinical Study or Phase IV/Post-Approval Clinical Study, or any other study in which human subjects or patients are dosed with a drug, whether approved or investigational, and including applicable Investigator Sponsored Clinical Studies.

1.19. “ CMC Development ” means the following chemistry, manufacturing and control activities within Manufacturing: test method development and validation, stability testing, process development, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development, and other related activities.

1.20. “ Code ” means the Internal Revenue Code of 1986, as amended from time to time (or any corresponding provisions of succeeding law).

1.21. “ Combination Clinical Study ” means [**], as such Clinical Studies may be revised, modified or amended in accordance with the terms of this Agreement.

1.22. “ Combination Product ” means a Product that contains a Licensed Compound as an active pharmaceutical ingredient together with one or more other active pharmaceutical ingredients in therapeutically relevant doses and is sold either as a fixed dose combination or as separate doses in a single package.

1.23. “ Commence ” or “ Commencement ” means, when used to describe a Clinical Study of a Product, the first dosing of the first human subject with such Product in such Clinical Study.

1.24. “ Commercialization ” or “ Commercialize ” means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Licensed Compound or Product, including activities to obtain and maintain Pricing and Reimbursement Approvals, secure and maintain market access and reimbursement, market, promote, distribute, and import a pharmaceutical or diagnostic product. For clarity, Commercialization shall not include Research, Development, Manufacture or Medical Affairs Activities.

1.25. “ Commercialization Plan ” means (a) with respect to the Products in the US Territory, the US Commercialization Plan and (b) with respect to the Products in the Ex-US Territory, the Ex-US Commercialization Plan.

 

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1.26. “ Commercialization Support Data ” means health economics and outcomes research (“ HECOR ”) data from patient reported outcomes, prospective observational studies and retrospective observational studies, and economic models and reimbursement dossiers.

1.27. “ Committee ” means the JSC, JDC, JCC or JMAC.

1.28. “ Confidential Information ” means (a) all trade secrets or confidential or proprietary information or tangible materials of the disclosing Party or its Affiliates provided or disclosed to the other Party or any of its Affiliates pursuant to this Agreement or any Related Agreement, (b) “Confidential Information” (as defined in the Prior CDA) that was disclosed by a Party or any of its Affiliates to the other Party or any of its Affiliates under the Prior CDA, and (c) the terms and conditions of this Agreement; provided , however , that Confidential Information shall not include information that:

(i) has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of the receiving Party or its Affiliates;

(ii) has been in the receiving Party’s or its Affiliates possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information (as evidenced by the receiving Party’s or such Affiliate’s written records or other competent evidence);

(iii) is subsequently received by the receiving Party or its Affiliate from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party;

(iv) that is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or

(v) has been independently developed by or for the receiving Party or its Affiliates without reference to, or use or disclosure of, the disclosing Party’s Confidential Information (as evidenced by the receiving Party’s or such Affiliate’s written records or other competent evidence);

provided , further , however , that clauses (ii) through (v) above cannot be applied to the terms and conditions of this Agreement.

Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.

 

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Joint Know-How shall be deemed to be the Confidential Information of both Parties, and both Parties shall be deemed to be the receiving Party and disclosing Party with respect thereto.

All Regulatory Filings owned by a Regulatory Owner shall be deemed to be the Confidential Information of such Regulatory Owner and such Regulatory Owner shall be deemed to be the disclosing Party and the other Party shall be deemed to be the receiving Party with respect thereto.

1.29. “ Control ” or “ Controlled ” means, with respect to any Know-How, Patent Right, other intellectual property right, compound or product, the legal authority or right (whether by ownership, license (other than a license granted pursuant to this Agreement) or otherwise) of a Party or its relevant Affiliate, to grant access, a license or a sublicense of or under such Know-How, Patent Right, intellectual property right, compound or product to the other Party, to the extent contemplated by this Agreement, without breaching the terms of any agreement with a Third Party, or misappropriating the proprietary or trade secret information of a Third Party; provided , however , that Know-How, Patent Rights or other intellectual property rights subject to a Third Party payment obligation as a result of the grant of a license to the other Party or arising out of the practice or use of such Know-How, Patent Rights, other intellectual property right, compound or product by a Party hereunder shall only be deemed to be “Controlled” by a Party if such payment obligations are included in the Blocking Third Party Intellectual Property Costs or Infinity Third Party Agreement Payments, as applicable (other than Know-How, Patent Rights and/or other intellectual property rights granted or arising under or pursuant to the Intellikine Agreement, which shall, notwithstanding anything herein to the contrary, be deemed “Controlled” by Infinity for all purposes hereunder regardless whether any related payment obligations are included in the Blocking Third Party Intellectual Property Costs or Infinity Third Party Agreement Payments hereunder).

1.30. “ Co-Promote ” or “ Co-Promotion ” means, with respect to a Product in the US, the joint marketing and promotion of such Product (including performing Sales Calls) in the US by both Parties or their respective Affiliates under the same Product Trademark(s) and in accordance with this Agreement and the US Commercialization Plan.

1.31. “ Cover ,” “ Covering ” or “ Covered ” means, when referring to a compound, product, invention or other Know-How: (a) with respect to a patent, that, in the absence of a license granted to a Person under a claim included in such patent, the practice by such Person of a specified activity with respect to such compound or product, or the practice by such Person of such invention or the use by such Person of such Know-How, would infringe such claim, or (b) with respect to a patent application, that, in the absence of a license granted to a Person under a claim included in such patent application, the practice by such Person of a specified activity with respect to such compound or product, or the practice by such Person of such invention or the use by such Person of such Know-How, would infringe such claim if such patent application were to issue as a patent.

1.32. “ Data ” means any and all data, results, pharmacology data, medicinal chemistry data, preclinical data, clinical data (including investigator reports (both preliminary and final), statistical analysis, expert opinions and reports, safety and other electronic databases), in any and all forms, including files, reports, raw data, source data (including patient medical records and

 

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original patient report forms, but excluding patient-specific data to the extent required by applicable Laws) and the like, in each case generated during the Development, Manufacture or Commercialization of any Licensed Compound or Product, including Commercialization Support Data.

1.33. “ Development ” or “ Develop ” means non-clinical and clinical drug or diagnostic development activities, including drug metabolism and pharmacokinetics, translational research, toxicology, pharmacology, test method development and stability testing, process and packaging development and improvement, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, conduct of Clinical Studies (but excluding any Phase IIIb or Phase IV/Post-Approval Clinical Study that is not required to obtain or maintain Regulatory Approval), regulatory affairs (including preparation for Regulatory Approval Application submission and other submission-related activities), and Regulatory Approval and Clinical Study regulatory activities (excluding regulatory activities directed to obtaining Pricing and Reimbursement Approvals). Development includes use and importation of the relevant compound or product to conduct such Development activities (with related importation and transportation costs only counted once as Development Costs and not double counted elsewhere). Development shall not include Research, Commercialization or Medical Affairs Activities.

1.34. “ Development Budget ” means the budget for conducting Development (and related Manufacturing) of Licensed Compounds and Products pursuant to and included in the GDP for the relevant Calendar Years in accordance with Section 4.1.1.

1.35. “ Development Costs ” means Development FTE Costs and Out-of-Pocket Costs, recorded as an expense in accordance with Accounting Standards, reasonably incurred and specifically identifiable by the Parties and their Affiliates in Developing the Products (and related Manufacturing activities) in the Field, in each case to the extent incurred in accordance with this Agreement, the GDP and the Development Budget, including:

(a) “ Development FTE Costs, ” which means the product of the number of Development FTEs times the FTE Rate, where a “ Development FTE ” means a scientific, regulatory, technical, legal, finance or other individual engaged full time for one (1) Calendar Year (consisting of at least a total of [**] hours per Calendar Year) in performing or supporting Development (and related Manufacturing) activities under the GDP. No additional payment shall be made with respect to any individual who works more than [**] hours per Calendar Year and any individual who devotes less than [**] hours per Calendar Year (or such other number as may be agreed by the JDC or JSC, as applicable) shall be treated as a Development FTE on a pro rata basis based upon the actual number of hours worked divided by [**];

(b) all Out-of-Pocket Costs for conducting Clinical Studies of Products (to the extent not captured below);

(c) Out-of-Pocket Costs (if not otherwise captured above) of Manufacturing or having Manufactured clinical supplies for such efforts as set forth in the GDP, including, as applicable: (i) the Supply Price of clinical supply of the Products; (ii) costs and expenses incurred to purchase, package or distribute Third Party comparator or Third Party combination drugs or devices; and (iii) costs and expenses of disposal of clinical samples;

 

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(d) Out-of-Pocket Costs representing fees incurred in connection with Regulatory Filings with respect to Products in the Field;

(e) Out-of-Pocket Costs (if not otherwise captured above) associated with pre- and post-approval commitments mandated by Governmental Authorities, to the extent incurred with respect to Products;

(f) Out-of-Pocket Costs (if not otherwise captured above) incurred in connection with CMC Development or qualification and validation of manufacturers, and if a Party or an Affiliate of a Party is established as a supplier, the Out-of-Pocket Costs to do so, including the Parties’ costs for transfer of process and manufacturing technology and analytical methods, scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections;

(g) Out-of-Pocket Costs (if not otherwise captured above) associated with activities related to pharmacovigilance, including establishing, updating and maintaining a global safety database for Products;

(h) Out-of-Pocket Costs (if not otherwise captured above) associated with Diagnostic Products, to the extent applicable to and used in the Development of a Product;

(i) Shared Patent Prosecution Costs; and

(j) any other Out-of-Pocket Costs incurred for activities specified in the GDP and included in the Development Budget.

Development Costs shall exclude all of the payments set forth in Section 7.1, all payments pursuant to Sections 7.2 and 7.3 and Allowable Expenses as defined in the Financial Exhibit and capital expenditures, and costs attributable to general corporate activities, executive management, investor relations, treasury services, business development, corporate government relations, external financial reporting and other overhead activities.

1.36. “ Development Threshold ” means an aggregate of US$667,000,000 in Development Costs, but excluding Combination Study Costs.

1.37. “ Diagnostic Product ” means, with respect to a Product, any biomarker or diagnostic assay or test to determine information regarding a subject or patient that is correlated with patient populations that do or do not respond to or to optimize treatment with such Product.

1.38. “ Diligent Efforts ” means, with respect to the performance of Development, Medical Affairs Activities, Commercialization, or Manufacturing activities with respect to the Licensed Compound or a Product by a Party, the carrying out of such activities using the level of effort required to carry out an obligation in a sustained, active and diligent manner consistent with such level of effort that companies in the pharmaceutical industry generally devote at the same stage of development or commercialization, as applicable, for their own internally developed

 

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pharmaceutical products in a similar therapeutic or disease area with similar market potential at a similar stage of product life, taking into account the regulatory structure involved, the anticipated profitability of the Product and other relevant factors, including safety and efficacy of the Product, the potential for additional indications, the level of competition in the market for the Product generally or for any particular indication, changes in clinical or regulatory strategy justified by compliance with the requirements of regulatory feedback from any Regulatory Authority, failed or inconclusive clinical studies, discovery of unanticipated toxicity or any significant adverse event or condition relating to the safety or efficacy of a Product, significant adverse changes in the targeted market conditions which affect the market potential of a Product, and the need for additional Clinical Studies to achieve appropriate labeling of a Product. “Diligent Efforts” shall be determined on a country-by-country basis, except that the Party may consider the impact of its efforts and resources expended with respect to any country on any other country.

1.39. “ DOJ ” means the United States Department of Justice.

1.40. “ Drug Regulation Laws ” means Laws regulating drugs and pharmaceutical products, including the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §301 et. seq. (the “ FFDCA ”), the Prescription Drug Marketing Act of 1987, the federal Controlled Substances Act, 21 U.S.C. §801 et. seq., and any guidance documents and policy and procedural manuals issued by the FDA.

1.41. “ Early Access Program ” means any program to provide patients with a Product prior to Regulatory Approval in any country in the Territory, including treatment INDs/protocols, named patient programs and compassionate use programs. For clarity, an Early Access Program with respect to a Product may continue to be performed following Regulatory Approval of such Product, and costs may continue to be incurred in accordance with the performance of such Early Access Program after Regulatory Approval.

1.42. “ Effective Date ” means the Execution Date.

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

1.44. “ European Union ” or “ EU ” means the countries of the European Union as constituted on the Execution Date and as it may be expanded or contracted from time to time after the Execution Date; provided that the EU shall always be deemed to include the United Kingdom, France, Germany, Italy and Spain.

1.45. “ Exclusivity Compound ” means a PI3K d / g dual inhibitor meeting the criteria set forth in Schedule 1.40.

1.46. “ Excluded Claim ” means a dispute, controversy or claim that concerns the validity, enforceability or infringement of a Patent Right, trademark or copyright.

1.47. “ Executive Officers ” means (a) with respect to Infinity, the Chief Executive Officer of Infinity (or a senior executive officer of Infinity designated by Infinity’s Chief Executive Officer), and (b) with respect to AbbVie, the Chief Executive Officer (or a senior executive officer of AbbVie or its Affiliates designated by AbbVie’s Chief Executive Officer). If the position of any of the Executive Officers identified in this Section 1.47 no longer exists due to a corporate

 

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reorganization, corporate restructuring or the like that results in the elimination of the identified position, the applicable title of the Executive Officer set forth herein shall be replaced with the title of another executive officer with responsibilities and seniority comparable to the eliminated Executive Officer, and the relevant Party shall promptly provide notice of such replacement title to the other Party.

1.48. “ Existing Infinity Third Party Agreements ” means (a) the Intellikine Agreement (b) the MICL Agreement, and (c) the Purdue Agreement; each such agreement as it may be amended from time to time.

1.49. “ Existing Infinity Third Party Agreement Payments ” means all payments under Existing Infinity Third Party Agreements incurred or paid after the Execution Date arising out of Development activities or Commercialization activities with respect to any Licensed Compound or Product under this Agreement, but excluding any royalty payments due by Infinity to Intellikine under the Intellikine Agreement or that may be due to Intellikine under any other agreement existing as of the Effective Date.

1.50. “ Ex-US Commercialization Plan ” means the commercialization plan with respect to the Commercialization of the Products in the Ex-US Territory for the relevant Calendar Years in accordance with Section 5.3.1, including an overall strategy for Commercialization and a tactical plan to accomplish such strategy, as developed, approved and amended in accordance with this Agreement and consistent with the Global Branding Strategy.

1.51. “ Ex-US Territory ” means worldwide excluding the US Territory.

1.52. “ Exploit ” or “ Exploitation ” means to make, have made, import, export, use, have used, sell, have sold, or offer for sale, including to Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), or otherwise dispose of Products.

1.53. “ FDA ” means the United States Food and Drug Administration or any successor agency thereto.

1.54. “ Field ” means with respect to the Licensed Compound, all human and non-human diagnostic, prophylactic, and therapeutic uses in cancer, including cancer specifically associated with blood-forming tissue, such as the bone marrow, or in the cells of the immune system, including leukemia, lymphoma and multiple myeloma.

1.55. “ Financial Exhibit ” means Exhibit A attached hereto, as may be amended from time to time by mutual written agreement of the Parties.

1.56. “ First Commercial Sale ” means, with respect to a Product in a country, the first sale for monetary value for use or consumption by the end user of such Product in such country after the receipt of the Marketing Authorization for such Product has been obtained in such country. Sales prior to receipt of Marketing Authorization for such Product, such as, pursuant to any Early Access Programs, so-called “treatment IND sales,” “named patient sales,” and “compassionate use sales,” shall not be construed as a First Commercial Sale.

 

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1.57. “ First Sale ” means, with respect to a Product in a country, the first sale of such Product to a Third Party in such country after the receipt of the Marketing Authorization for such Product in such country, if such Marketing Authorization is required, or, if Marketing Authorization is not required, such as, for example, pursuant to any Early Access Programs, so-called “treatment IND sales,” “named patient sales,” and “compassionate use sales,” upon the first such sale.

1.58. “ FTC ” means the United States Federal Trade Commission.

1.59. “ FTE ” means the equivalent of the work of one (1) employee full time for one (1) Calendar Year (consisting of at least a total of [**] hours per Calendar Year) of work.

1.60. “ FTE Rate ” means, with respect to Development FTEs, [**] United States Dollars ($[**]), and for all other FTEs, [**] United States Dollars ($[**]), which rates will increase or decrease January 1 of each Calendar Year (starting with January 1, 2015) in accordance with the percentage year-over-year increase or decrease in (A) with respect to the U.S., the Consumer Price Index – Urban Wage Earners and Clerical Workers, US City Average, All Items, 1982-84 = 100, published by the United States Department of Labor, Bureau of Labor Statistics (or its successor equivalent index) over the twelve (12) month period preceding each such January 1, and (B) with respect to any other country, the equivalent index calculated by the relevant Governmental Authority in such country.

1.61. “ Generic Entry ” means, with respect to a Product and country, the first sale of a Generic Product.

1.62. “ Generic Product ” means, with respect to a Product and country, any pharmaceutical product that (a) is sold by a Third Party under a Regulatory Approval Application granted by a Regulatory Authority to such Third Party, which Third Party is not a licensee or Sublicensee of a Party or its Affiliates, or any of their licensees or Sublicensees, and has not obtained such Product from a chain of distribution including a Party, its Affiliates or any of their licensees or Sublicensees, (b) contains the applicable Licensed Compound as an active pharmaceutical ingredient, and (c) is approved in reliance, in whole or in part, on the prior approval of such Product as determined by the applicable Regulatory Authority (pursuant to 21 U.S.C. 355(b)(2), 21 U.S.C. 355(j), a separate Regulatory Approval Application, compendia listing, other drug approval application or otherwise, including foreign equivalents of the foregoing). A Product licensed or produced by one of the Parties or their respective Affiliates (i.e., an authorized generic product) will not constitute a Generic Product.

1.63. “ GCP ” or “ Good Clinical Practice ” means all applicable then-current standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Studies, including, as applicable, (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2013) as last amended at the 64 th World Medical Association in October 2013 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312

 

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(Investigational New Drug Application), and (d) the equivalent applicable Laws in any relevant country, in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

1.64. “ GDP ” or “ Global Development Plan ” means the plan for the Parties’ worldwide Development (and related Manufacturing) of the Product in the Field, including regulatory strategy, identification of specific Clinical Studies to be conducted, naming the Oncology Indications to be pursued, and general design parameters, including patient enrollment targets, combination agents and comparators and including the Development Budget, for the relevant Calendar Years in accordance with Section 4.1.1 in accordance with the terms of this Agreement. The initial GDP is attached hereto as Exhibit C .

1.65. “ Global Branding Strategy ” means the global branding strategy for Products in the Field throughout the world, including, with respect to each such Product, a life cycle plan, brand vision, positioning, key messaging, concept and imagery, Product Trademarks (including name and logos), brand public relations and supporting market research.

1.66. “ GLP ” or “ Good Laboratory Practice ” means all applicable then-current standards for laboratory activities for pharmaceuticals, as set forth in the FDA’s Good Laboratory Practice regulations as defined in 21 C.F.R. Part 58 or the Good Laboratory Practice principles of the Organization for Economic Co-Operation and Development (OECD), and such standards of good laboratory practice as are required by the European Union and other organizations and governmental agencies in countries in which a Product is intended to be sold, to the extent such standards are not less stringent than United States Good Laboratory Practice.

1.67. “ GMP ” or “ Good Manufacturing Practice ” means all applicable then-current standards for Manufacturing, including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Sections 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the ICH Q7 guidelines, and (d) the equivalent applicable Laws in any relevant country, each as may be amended and applicable from time to time.

1.68. “ Governmental Authority ” means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal, official or officer, exercising executive, judicial, legislative, police, regulatory, administrative or taxing authority or functions of any nature pertaining to government.

1.69. “ Government Health Care Programs ” means the Medicare program (Title XVIII of the Social Security Act), the Medicaid program (Title XIX of the Social Security Act), TRICARE, the Federal Employee Health Benefits Program, and other foreign, federal, state and local governmental health care plans and programs.

1.70. “ Government Order ” means any order, writ, judgment, injunction, decree, stipulation, ruling, determination or award entered by or with any Governmental Authority.

 

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1.71. “ Health Care Laws ” means Laws relating to Government Health Care Programs, Private Health Care Plans, privacy and confidentiality of patient health information and human biological materials, including, in the United States, federal and state Laws pertaining to the federal Medicare and Medicaid programs (including the Medicaid rebate program); federal Laws pertaining to the Federal Employees Health Benefit Program, the TRICARE program and other Government Health Care Programs; federal and state Laws applicable to health care fraud and abuse, kickbacks, physician self-referral and false claims (including 42 U.S.C. §1320a-7a, 42 U.S.C. §1320a-7b, 42 U.S.C. §1395nn and the federal Civil False Claims Act, 31 U.S.C. §3729 et. seq.); the Health Insurance Portability and Accountability Act of 1996; the Patient Protection and Affordable Care Act (“ ACA ”); and 45 C.F.R. Part 46; as well as similar Laws in jurisdictions outside the United States.

1.72. “ HSR Act ” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (15 U.S.C. §18a), and the rules and regulations promulgated thereunder.

1.73. “ ICH ” means the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

1.74. “ Incremental Withholding Tax ” means the net increase in Withholding Tax for any taxable year caused by AbbVie Withholding Tax Actions that are not Required Withholding Tax Actions occurring on and after the Execution Date, provided the net aggregate increase exceeds [**] Dollars calculated on an annual basis using the exchange rate on the date of the payment subject to Withholding Tax. For clarity, Incremental Withholding Tax shall include the entire net increase in Withholding Tax caused by AbbVie Withholding Tax Actions that are not Required Withholding Tax Actions if the annual net aggregate increase of [**] Dollars has been reached (i.e. not only amounts in excess of [**] Dollars).

1.75. “ IND ” means an application filed with a Regulatory Authority for authorization to commence Clinical Studies, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or regulatory jurisdictions, (i.e., Clinical Trial Application (CTA)) and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.

1.76. “ Indemnified Party ” means a Person entitled to indemnification under ARTICLE 11.

1.77. “ Indemnifying Party ” means a Party from whom indemnification is sought under ARTICLE 11.

1.78. “ Infinity-Borne Development Costs ” means all Development Costs that are not Shared Development Costs.

1.79. “ Infinity Intellectual Property ” means Infinity Know-How and Infinity Patent Rights.

 

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1.80. “ Infinity Know-How ” means all Know-How Controlled by Infinity or any of its Affiliates, as of the Execution Date or during the Term, that is not generally known and is necessary or useful for the Development, Manufacture or Commercialization of any Licensed Compound or Product in the Field in the Territory, including the rights of Infinity or its Affiliates in Infinity Sole Inventions and Joint Inventions, but excluding any Know-How to the extent Covered by published Infinity Patent Rights.

1.81. “ Infinity Patent Rights ” means all Patent Rights Controlled by Infinity or any of its Affiliates, as of the Execution Date or during the Term, that are necessary or useful for the Development, Manufacture or Commercialization of any Licensed Compound or Product in the Field, including the rights of Infinity or its Affiliates in Joint Patent Rights and in Patent Rights Covering Infinity Sole Inventions. As of the Execution Date, the Infinity Patent Rights include the Patent Rights set forth in Exhibit B .

1.82. “ Infinity Third Party Agreements ” means (a) the Existing Infinity Third Party Agreements and (b) any Third Party agreement entered into by Infinity pursuant to Section 3.5; each such agreement as it may be amended from time to time in accordance with the terms of this Agreement.

1.83. “ Infinity Third Party Agreement Payments ” means (a) all payments under Infinity Third Party Agreements entered pursuant to Section 3.5 that arise out of the Development or Commercialization of any Licensed Compound or Product under this Agreement, but excluding any payments due by Infinity to Intellikine under any agreement that grants to Infinity rights to any intellectual property granted to Infinity at any time under the Intellikine Agreement, and (b) Existing Infinity Third Party Agreement Payments, except amounts paid (either directly or as reimbursement) under Infinity Third Party Agreements in preparing, filing, prosecuting or maintaining Patent Rights.

1.84. “ Intellikine ” means Intellikine LLC.

1.85. “ Intellikine Agreement ” means the Amended and Restated Development and License Agreement, made as of December 24, 2012, by and between Intellikine and Infinity, as amended by the Amendment to the Amended and Restated Development and License Agreement dated as of July 29, 2014 and as may be further amended, [**].

1.86. “ Investigator Sponsored Clinical Study ” means a human clinical study of a pharmaceutical or diagnostic product that is sponsored and conducted by a Third Party, other than pursuant to an IND held by a Party, under an agreement with a Party or its Affiliate pursuant to which such Party or such Affiliate provides clinical supplies of such product or funding for such clinical study.

1.87. “ Joint Patent Rights ” means Patent Rights Covering Joint Inventions.

1.88. “ Know-How ” means all technical information, know-how and data, including inventions, discoveries, trade secrets, specifications, instructions, processes, formulae, materials, expertise and other technology applicable to formulations, compositions or products or to their manufacture, development, registration, use or marketing or to methods of assaying or testing them or processes for their manufacture, formulations containing them or compositions incorporating or comprising them, and including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety, quality control,

 

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manufacturing, Data, information contained in Regulatory Filings, instructions, processes, formulae, expertise and information, relevant to the research, development, manufacture, use, importation, offering for sale or sale of, or which may be useful in studying, testing, developing, producing or formulating, products, or intermediates for the synthesis thereof. Know-How excludes the Patent Rights covering any inventions.

1.89. “ Label Expansion ” means, following first receipt of Regulatory Approval for a pharmaceutical or diagnostic product in an Oncology Indication (the “ First Approval in an Oncology Indication ” for such Product), any subsequent receipt of Regulatory Approval for such Product in the same Oncology Indication as such First Approval in an Oncology Indication, for a different subpatient population, line of therapy or new use as a monotherapy or in combination with another treatment or drug for such Oncology Indication.

1.90. “ Law ” means any applicable multinational, federal, national, state, provincial, county or local or other law, statute, standard, ordinance, code, rule, regulation, resolution or promulgation, or any Government Order, or any license, franchise, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law, and shall include, as applicable, GLP, GCP, GMP, Drug Regulation Laws, Clinical Investigation Laws and Health Care Laws, the rules or regulations of the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States or of any stock exchange (including NASDAQ), all applicable United States and foreign laws with respect to the transfer of pharmaceutical or diagnostic products and related technical data to countries other than the United States, including the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations, the U.S. Foreign Corrupt Practices Act (the “ FCPA ”), the UK Bribery Act 2010, and all applicable government importation laws and regulations of a particular country for pharmaceutical or diagnostic products made outside the particular country in which such pharmaceutical or diagnostic products are used or sold.

1.91. “ Licensed Compound ” means the compound known as IPI-145, as further described in Exhibit D , and any racemates, salts, metabolites, esters, isomers, diastereomers, tautomers, enantiomers, prodrug forms, hydrates, solvates, intermediates, polymorphs and degradants thereof, in each case, that have substantially the same pharmacological effect, in crystal, powder or other form. As used in this Agreement, except where not appropriate in context, the Licensed Compound also means any Product containing the Licensed Compound.

1.92. “ Losses ” means damages, losses, liabilities, costs (including costs of investigation, defense), fines, penalties, taxes, expenses, or amounts paid in settlement (in each case, including reasonable attorneys’ and experts’ fees and expenses), in each case resulting from an Action by a Third Party.

1.93. “ MAA ” means (a) a marketing authorization application filed with (i) the EMA under the centralized EMA filing procedure or (ii) a Regulatory Authority in any EU country if the centralized EMA filing procedure is not used, or (b) any other equivalent or related regulatory submission; in either case to gain approval to market a pharmaceutical or diagnostic product in any country in the EU, and, in each case, including any amendments thereto, and supplemental applications but excluding Pricing and Reimbursement Approval applications.

 

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1.94. “ Major Market Country ” means each of the United Kingdom, France, Germany, Italy, Spain, and Japan.

1.95. “ Manufacture ” or “ Manufacturing ” means activities directed to producing, manufacturing, scaling up, processing, filling, finishing, packaging, labeling, quality assurance testing and release, shipping and storage of a pharmaceutical or diagnostic product or component thereof (including production of drug substance and drug product, in bulk form, for preclinical and Clinical Studies and for Commercialization).

1.96. “ Manufacturing Plan ” means the plan for the Parties’ worldwide preclinical and clinical or commercial, as the case may be, Manufacturing of the Product in the Field.

1.97. “ Marketing Authorization ” means the grant of all necessary permits, registrations, authorizations, licenses and approvals (or waivers) required for the Manufacture, Commercialization, promotion, marketing, storage, import, export, transport, distribution, use, offer for sale, sale or other commercialization of a Product in any country, including, where required, Pricing and Reimbursement Approvals.

1.98. “ Medical Affairs Activities ” means the following activities, to the extent related to a Product in the Field in the Territory: responding to external inquiries or complaints, the planning for and conduct of Investigator Sponsored Clinical Studies not included in the GDP, medical education, HECOR, speaker programs, advisory boards, thought leader activities, educational grants and fellowships, local country government affairs, Phase IIIb Clinical Studies, Phase IV/Post-Approval Clinical Studies, generating Commercialization Support Data, deployment of MSLs, medical affairs clinical trial management, MDs in field (other than MSLs), scientific publications and medical communications. For clarity, Medical Affairs Activities shall not include Research, Development, Manufacture or Commercialization activities.

1.99. “ Medical Affairs FTE Costs ” means the product of the number of Medical Affairs FTEs times the FTE Rate, where a “Medical Affairs FTE” means a scientific, medical, project management, operations, technical or other individual engaged full time for one (1) Calendar Year (consisting of at least a total of [**] hours per Calendar Year) in performing or supporting Medical Affairs Activities. No additional payment shall be made with respect to any individual who works more than [**] hours per Calendar Year and any individual who devotes less than [**] hours per Calendar Year (or such other number as may be agreed by the JMAC or JSC, as applicable) shall be treated as a Medical Affairs FTE on a pro rata basis based upon the actual number of hours worked divided by [**]; provided that such individual devotes a minimum of [**] hours per Calendar Year to performing or supporting Medical Affairs Activities under the Medical Affairs Plan.

1.100. “ Medical Affairs Plan ” means a plan for the Parties’ worldwide Medical Affairs Activities, including the allocation of such activities to the Parties and the associated Medical Affairs Budget included therein.

1.101. “ MICL Agreement ” means the Termination and Revised Relationship Agreement, entered into as of July 17, 2012, by and between Mundipharma International Corporation Limited and Infinity.

 

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1.102. “ MSL ” means medical science liaison.

1.103. “ MSL Deployment Plan ” means, with respect to a Product and a country or region, a plan that defines the overall MSL FTEs in such country or region and includes: target audience assessment and coverage requirements, and coordinated coverage and targeting plan between MSL teams from each Party.

1.104. “ MSL FTE ” means, with respect to a Product in a country, the time and effort of MSLs that, in the aggregate, is equivalent to the time and effort of one (1) employee devoted exclusively to MSL activities based on [**] person hours per year.

1.105. [**].

1.106. [**].

1.107. “ NDA ” or “ New Drug Application ” means an application submitted to the FDA pursuant to 21 U.S.C. §505(b), which contains complete details of the manufacture and testing of a new drug, for purposes of obtaining Regulatory Approval for such new drug in the United States, for a particular Oncology Indication, and, with respect to a Diagnostic Product, a premarket approval or comparable application, in each case including amendments thereto and supplemental applications.

1.108. “ Net Sales ” means, with respect to a Product for any period, the total gross amount billed or invoiced on sales of such Product during such period by a Party, its Affiliates, or Sublicensees (other than Sublicensees that are wholesalers or distributors) in the Territory to Third Parties (including wholesalers or distributors that are also Sublicensees), in bona fide arm’s length transactions, less the following deductions (such deductions, the “ Deductions ”), in each case related specifically to the Product and actually allowed and taken by such Third Parties and not otherwise recovered by or reimbursed to such Party, its Affiliates, or Sublicensees:

(a) trade, cash and quantity discounts;

(b) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities or other payees;

(c) taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced;

(d) amounts repaid or credited by reason of rejections, defects, return goods allowances, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs;

(e) the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers or Medicare Prescription Drug Plans relating to such Product;

(f) any invoiced amounts from a prior period which have not been collected and have been written off by a Party or its Affiliates, including bad debts, to the extent such amounts have not been previously deducted; provided that any such amounts that are written off shall be added back in a subsequent period to the extent later collected;

 

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(g) freight, insurance, import/export, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such Product; and

(h) any other similar and customary deductions that are consistent with the selling Party’s Accounting Standards, but which are not be duplicative of the deductions specified in (a) – (g) above.

Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes, in all cases, without consideration. Net Sales shall include the amount or fair market value of all other consideration received by a Party, its Affiliates or Sublicensees in respect of the Product, whether such consideration is in cash, payment in kind, exchange or other form. Net Sales shall not include sales between or among a Party, its Affiliates, or Sublicensees.

Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of the selling Party, its Affiliates, or Sublicensees, which must be in accordance with its Accounting Standards.

For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 7.7.

In the event a Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows:

(a) If a Party, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction, (i) a product containing as its sole active ingredient a Licensed Compound contained in such Combination Product (the “ Mono Product ”) and (ii) products containing as their sole active ingredients the other active ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where: “A” is the Party’s (or its Affiliate’s or Sublicensee’s, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction and “B” is such Party’s (or its Affiliate’s or Sublicensee’s, as applicable) average Net Sales price during the period to which the Net Sales calculation applies in such country or other jurisdiction, for products that contain as their sole active ingredients the other active ingredients in such Combination Product.

(b) If a Party, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction the Mono Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredients the other active ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction A/C where: “A” is a

 

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Party’s (or its Affiliate’s or Sublicensee’s, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction, and “C” is such Party’s (or its Affiliate’s or Sublicensee’s, as applicable) average Net Sales price in such country or other jurisdiction during the period to which the Net Sales calculation applies for such Combination Product.

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

(d) If a Party, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction both the Mono Product and the other active ingredient or ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction 1/(1+F) where: “F” is the number of other active ingredients (other than a Licensed Compound) in such Combination Product;

provided , however , that if the Combination Product includes a Licensed Compound and AbbVie Combination Compound as the only active ingredients, then the Net Sales attributable to such Combination Product hereunder shall be equal to [**] percent ([**]%) of the Net Sales of such Combination Product.

1.109. “ Non-Oncology Indication ” means any disease, condition, disorder or syndrome, or sign or symptom of, or associated with, a disease, condition, disorder or syndrome, excluding all Oncology Indications.

1.110. “ Oncology Indication ” means a cancerous condition resulting from a separate and distinct hematological cancer, tumor type or other cancer that is the basis for a separate and distinct Regulatory Approval. Non-limiting examples of distinct Oncology Indications include: chronic lymphocytic leukemia, indolent non-Hodgkin lymphoma, follicular lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, peripheral T-cell lymphomas, acute myeloid leukemia, acute lymphoblastic leukemia, Hodgkin lymphoma, renal cell carcinoma, non-small cell lung cancer, colon cancer, breast cancer, pancreatic cancer, etc. On a Product-by-Product and country-by-country basis, once a Product has received Regulatory Approval in an Oncology Indication (a) where such Regulatory Approval is for the use of such Product alone or in combination with other treatment modalities, the subsequent receipt of Regulatory Approval of such Product in combination with other treatment modalities or alone, respectively, for such Oncology Indication shall not be considered a different Oncology Indication but shall be considered a Label Expansion with respect to such Oncology Indication for such Product, (b) where such Regulatory Approval is for use of such Product in one line of therapy, the subsequent receipt of Regulatory Approval of such Product in another line of therapy for such Oncology

 

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Indication shall not be considered a different Oncology Indication but shall be considered a Label Expansion with respect to such Oncology Indication for such Product or (c) where such Regulatory Approval is for the use of such Product within a defined subset of patients within an Oncology Indication, the subsequent receipt of Regulatory Approval of such Product within a different defined subset of patients within such Oncology Indication (e.g., elderly, or genetically defined patients subgroups such as chronic lymphocytic leukemia patients with a 17 p deletion) shall not be considered a different Oncology Indication but shall be considered a Label Expansion with respect to such Oncology Indication for such Product.

1.111. “ Orange Book ” means the publication Approved Drug Products with Therapeutic Equivalence Evaluations that identifies drug products approved on the basis of safety and effectiveness by the FDA under the FFDCA.

1.112. “ Out-of-Pocket Costs ” means (a) amounts paid to Third Party vendors or contractors for services or materials provided by them directly in the performance of activities under the GDP, the Medical Affairs Plan or the relevant Commercialization Plan, as applicable, to the extent such services or materials apply solely and directly to a Licensed Compound or Product (or such amounts paid to Third Parties for other activities not included in determination of Development Costs or Allowable Expenses, but for which sharing of Out-of-Pocket Costs is otherwise specified in this Agreement), or (b) solely with respect to Section 7.5.3, the amounts paid to an independent, certified public accountant to conduct an audit in accordance with Section 7.5.1. For clarity, Out-of-Pocket Costs do not include payments for internal expenses or the out-of-pocket portion, if any, of the following expenses: salaries or benefits; facilities; utilities; general office or facility supplies; insurance (other than clinical trial insurance); information technology, capital expenditures or the like.

1.113. “ Party ” means either Infinity or AbbVie; “ Parties ” means Infinity and AbbVie, collectively.

1.114. “ Patent Costs ” means all reasonable Out-of-Pocket Costs incurred by a Party or its Affiliate in preparing, filing, prosecuting or maintaining the relevant Patent Rights, which, for purposes of this Section, shall not include the [**] (including the reasonable fees and expenses paid to outside counsel and other Third Parties, and filing and maintenance fees paid to governmental authorities) recorded as an expense by a Party or any of its Affiliates in accordance with Accounting Standards after the Effective Date, during the Term of and pursuant to this Agreement, including costs of patent interference, opposition, reissue, or re-examination proceedings, or any other pre- or post-grant proceedings in the USPTO, EPO or foreign equivalent, and filing and registration fees with respect to the relevant Patent Rights.

1.115. “ Patent Rights ” means all patents and patent applications (including provisional applications), including all divisionals, continuations, substitutions, continuations-in-part, re-examinations, re-issues, additions, renewals, extensions, confirmations, registrations, any other pre- or post-grant forms of any of the foregoing, any confirmation patent or registration patent or patent of addition, utility models, patent term extensions, and supplemental protection certificates or requests for continued examinations, foreign counterparts, and the like of any of the foregoing.

 

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1.116. “ Person ” means any natural person, corporation, general partnership, limited partnership, joint venture, proprietorship or other business organization or a Governmental Authority.

1.117. “ Phase I Clinical Study ” means a clinical study in humans which provides for the first introduction into humans of a pharmaceutical product, conducted in normal subjects or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in Federal Regulation 21 C.F.R. §312.21(a) and its foreign equivalents.

1.118. “ Phase II Clinical Study ” means a clinical study in humans of the safety, dose ranging and efficacy of a pharmaceutical product, as described in Federal Regulation 21 C.F.R.§312.21(b) and its foreign equivalents.

1.119. “ Phase III Clinical Study ” means a controlled clinical study, or a portion of a controlled study, in humans of the efficacy and safety of a pharmaceutical product, which study (in its entirety or portion, as applicable), is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular Oncology Indication in a manner sufficient to file an NDA, MAA or other Regulatory Approval Application to obtain Regulatory Approval, as further defined in Federal Regulation 21 C.F.R. §312.21(c) and its foreign equivalents. For the sake of clarity, with respect to what is commonly called a phase 2/3 study, the Phase III Study definition is met upon the first patient, first visit in the portion of such study that is prospectively designed to demonstrate statistically whether such pharmaceutical product is effective and safe for use in a particular Oncology Indication in a manner sufficient to file an NDA, MAA or other Regulatory Approval Application to obtain Regulatory Approval, as further defined in Federal Regulation 21 C.F.R. §312.21(c) and its foreign equivalents.

1.120. “ Phase IIIb Clinical Study ” means a clinical study conducted after the submission of a Regulatory Approval Application, but prior to receipt of Marketing Authorization. Such studies may supplement prior studies, complete prior studies, or be directed towards new types of studies or Phase IV evaluations.

1.121. “ Phase IV/Post-Approval Clinical Study ” means a clinical study in humans initiated in a country after receipt of Regulatory Approval for a pharmaceutical or diagnostic product in such country, usually within or in support of the approved product labeling.

1.122. “ Pricing and Reimbursement Approval ” means, with respect to a pharmaceutical or diagnostic product, the governmental approval, agreement, determination or decision establishing the price or level of reimbursement for such product, in a given jurisdiction prior to sale of such product in such jurisdiction.

1.123. “ Private Health Care Plans ” means non-governmental Third Party health care payors and plans, including insurance companies, health maintenance organizations and other managed care organizations, Blue Cross and Blue Shield plans and self-funded employers.

1.124. “ Prior CDA ” means the Confidential Disclosure Agreement between Infinity and AbbVie, dated [**] (the “ Prior CDA Effective Date ”).

 

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1.125. “ Product ” means any product comprising or containing any Licensed Compound, alone or in combination with other active pharmaceutical ingredients, in any and all forms, in current and future formulations, dosage forms and strengths, and delivery modes; provided , however , that Product shall not include any compound (other than a Licensed Compound) that is Covered by or embodies any Patent Rights or Know-How and that is, in either case, Controlled by a Party or any of its Affiliates, without such Party’s prior written consent. As used in this Agreement, except where not appropriate in context, the Product also (a) means the Licensed Compound contained in such Product, and (b) includes any Diagnostic Product related to such Product, to the extent Controlled by the relevant Party.

1.126. “ Product Liability Action ” means any Action brought by a Third Party to the extent in respect of any personal bodily injury or death (or risk of personal bodily injury or death) resulting from the use or ingestion of, or exposure to, a Product following the Effective Date, whether based on negligence, strict product liability or any other product liability theory, including liability predicated on any alleged or actual manufacturing, design or formulation defect, any failure to warn, any breach of any express or implied warranties or any breach of this Agreement or a Related Agreement.

1.127. “ Product Liability Costs ” means those Out-of-Pocket Costs, Development FTE Costs and Commercial FTE Costs incurred in connection with the defense of any Product Liability Actions.

1.128. “ Product Trademark ” means, with respect to a Product, any trademark or service mark as may be proposed by Infinity pursuant to Section 8.7.2(a), for use in connection with the Commercialization of such Product in the Field anywhere in the world, or accompanying logos, trade dress or indicia of origin.

1.129. “ Promotional Materials ” means, with respect to a Product, sales, promotion, market access and advertising materials, including Product packaging, help-seeking and disease-awareness advertisements, pertaining to such Product.

1.130. “ Purdue Agreement ” means the Termination and Revised Relationship Agreement, entered into as of July 17, 2012, by and between Purdue Pharmaceuticals Products L.P. and Infinity.

1.131. “ Recall ” means a Party’s removal or correction of a Product that the FDA (or analogous foreign entity) considers to be in violation of the laws it administers and against which the agency (or analogous foreign entity) would initiate legal action, e.g. , seizure. For clarity, a Recall does not include a market withdrawal or a stock recovery.

1.132. “ Regulatory Approval Application ” means (a) an NDA, or (b) an MAA or other application to seek Regulatory Approval of a Product in any country(ies) outside the United States, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies).

1.133. “ Regulatory Approval ” means the approval of the applicable Regulatory Authority necessary for the marketing and sale of a Product in the Field in a country(ies), excluding separate Pricing and Reimbursement Approval that may be required, and including Label Expansions.

 

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1.134. “ Regulatory Authority ” means any multinational, federal, national, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the clinical development, manufacture, marketing and sale of a pharmaceutical or diagnostic product in a country, including FDA in the United States and EMA in the EU.

1.135. “ Regulatory Filing ” means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to a Licensed Compound or corresponding Product, or its use or potential use in the Field, including any documents submitted to any Regulatory Authority, including INDs, Regulatory Approval Applications, and all correspondence with any Regulatory Authority with respect to any Licensed Compound or Product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).

1.136. “ Related Agreement ” means each of the following: each Supply Agreement, the Quality Agreement and any other agreement between a Party or any of its Affiliates, on the one hand, or the other Party or any of its Affiliates, on the other hand, entered into pursuant to this Agreement or any other Related Agreement.

1.137. “ Required Incremental Withholding Tax ” means the net increase in Withholding Tax for any taxable year caused by an AbbVie Withholding Tax Action that is a Required Withholding Tax Action occurring on and after the Execution Date.

1.138. “ Required Withholding Tax Action ” means an AbbVie Withholding Tax Action that AbbVie takes to Commercialize a Product that (i) is required by Law (i.e., there is no other permitted way for AbbVie to Commercialize such Product other than to assign, license or otherwise transfer the rights to the Product to a foreign Affiliate of AbbVie, its successor or Sublicensee), or (ii) represents the only commercially reasonable alternative to Commercialize such Product, as determined by the JSC, the approval of which from each Party’s representatives shall not be unreasonably withheld.

1.139. “ Required Withholding Tax Benefit ” means any tax deducted by Infinity (or any Infinity Affiliates or successors) or claimed by Infinity (or any Infinity Affiliates or successors) as a credit under Code section 901, 902 or 960, for a taxable year that is attributable to any Required Incremental Withholding Tax, less any prior year credits for Required Incremental Withholding Tax that are disallowed as a result of the carryback of net operating losses.

1.140. “ Research ” means, with respect to a compound, activities prior to the initiation of the first IND-enabling GLP toxicology study for such compound, including but not limited to conducting medicinal chemistry. Research shall not include Development, Commercialization, Manufacturing or Medical Affairs Activities.

1.141. “ Residual Knowledge ” means knowledge, techniques, experience and Know-How in intangible form (i.e., not written or other documentary form) that the receiving Party can demonstrate are incidentally and unintentionally retained in memory by employees of the receiving Party who have had access to the Confidential Information of the disclosing Party and where the source of the Confidential Information has become remote (e.g., as a result of the passage of time or the employee’s subsequent exposure to information of a similar nature from

 

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other sources) such that the employee is not able to identify the disclosing Party as the source of the Confidential Information without refreshing his or her recollection. In no event, however, will Residual Knowledge include any knowledge, techniques, experience and Know-How to the extent (at any time, for such time) within the scope of any Valid Claim or copyright owned or Controlled by the disclosing Party.

1.142. “ Sales Call ” means, with respect to a Product in the US, a one-on-one, face-to-face contact (or any other type of contact, including telephone contact, that the Parties mutually agree, through the JCC, constitutes sufficient contact for purposes of this definition) of a Sales Representative with a medical professional with prescribing authority during which scientific or medical information about the use of such Product for any indication in the Field for which such Product has received Regulatory Approval in the US is discussed, and, for three (3) years following such Regulatory Approval, during which no more than two (2) products (including the Product) are so presented.

1.143. “ Sales Force Deployment Plan ” means, with respect to a Product in the US, a plan that defines the overall Sales Representative FTEs in the US and includes: target audience assessment and coverage requirements, and coordinated coverage and targeting plan between sales teams from each Party.

1.144. “ Sales Manager FTE ” means with respect to a Product in the US, the total number of sales managers supporting the Sales Representatives making Sales Calls with respect to such Product in such country.

1.145. “ Sales Representative FTE ” means, with respect to a Product in the US, the total number of Sales Representatives making Sales Calls with respect to such Product in the US, calculated based on the percentage of such individual’s incentive bonus target applicable to such Product in such country. By way of example, if fifty percent (50%) of such individual’s incentive bonus target is available for such Product in the US, then such individual shall be fifty percent (50%) of a Sales Representative FTE. The same incentive calculation methodology shall be used to determine the Sales Manager FTEs supporting the Product.

1.146. “ Sublicensee ” means, with respect to a Party, a Third Party sublicensee of rights granted to such Party under this Agreement or a Third Party licensee of rights with respect to a Licensed Compound or Product which rights are retained by such Party under this Agreement with respect to such Licensed Compound or Product. For clarity, the rights and licenses granted to Intellikine by Infinity upon termination of the Intellikine Agreement shall not be deemed such a sublicense or license granted by Infinity hereunder and, with respect to the rights and licenses granted to Intellikine upon termination of the Intellikine Agreement, Intellikine and its Affiliates, licensees and sublicensees shall not be considered a Sublicensee of Infinity.

1.147. “ Territory ” means worldwide.

1.148. “ Third Party ” means any Person other than a Party or any of its Affiliates.

1.149. “[**].

 

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1.150. “ United States ,” “ U.S. ” “ US ” or “ US Territory ” means the United States of America and its territories and possessions.

1.151. “ US Commercialization Budget ” means the budget for conducting Commercialization activities for the Products in the US Territory pursuant to the US Commercialization Plan for the relevant Calendar Years in accordance with Section 5.3.1.

1.152. “ US Commercialization Plan ” means the commercialization plan with respect to the Commercialization of the Products in the US Territory for the relevant Calendar Years in accordance with Section 5.3.1, including an overall strategy for Commercialization, a tactical plan to accomplish such strategy, a plan regarding promotional educational/materials, sales force training, market research and advisory board strategy, a public relations plan, HECOR strategy, an advertising/public relations plan, managed care/contracting strategy, sales force alignment, the US Commercialization Budget, the Sales Force Deployment Plan, pricing strategy and determination of pricing, and annual forecasts including demand units, supply units, Gross Sales and Net Sales (which forecasts the Parties acknowledge and agree are non-binding and are not intended to provide any assurance of future commercial success), in each case for the Products in the US Territory, on a Product-by-Product basis, as developed, approved and amended in accordance with this Agreement and consistent with the Global Branding Strategy.

1.153. “ Valid Claim ” means a claim (including a process, use, or composition of matter claim) of an issued and unexpired patent that has not (a) irretrievably lapsed or been abandoned, revoked, dedicated to the public or disclaimed or (b) been held invalid, unenforceable or not patentable by a court, governmental agency, national or regional patent office or other appropriate body that has competent jurisdiction, which holding, finding or decision is final and unappealable or unappealed within the time allowed for appeal.

1.154. “ Withholding Tax ” means any tax required to be withheld and deducted from a payment made (or to be made) pursuant to this Agreement.

1.155. “ Withholding Tax Benefit ” means any tax deducted by Infinity (or any Infinity Affiliates or successors) or claimed by Infinity (or any Infinity Affiliates or successors) as a credit under Code section 901, 902 or 960, for a taxable year that is attributable to any Incremental Withholding Tax, less any prior year credits for Incremental Withholding Tax that are disallowed as a result of the carryback of net operating losses.

1.156. Additional Definitions . Each of the following definitions is set forth in the Section of this Agreement indicated below:

 

Definition

  

Section

1974 Convention    14.4
AbbVie    Preamble
[**]    8.1.3
AbbVie Indemnified Parties    11.1
AbbVie Sole Inventions    8.1.1
Acquisition Transaction    3.7.3(a)
ADR    13.1
Adverse Ruling    12.2.1(a)

 

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Definition

  

Section

Agreement Wind-Down Period    12.3.13
Alliance Manager    2.10
Alliance Manager Expenses    Financial Exhibit
Allowable Expenses    Financial Exhibit
[**]    4.1.6(c)
[**]    4.1.6(c)
Bankruptcy Code    3.7.4
Breaching Party    12.2.1
Collaboration Losses    Financial Exhibit
Combination Study Costs    4.6.1
Commercial FTE    Financial Exhibit
Commercial FTE Costs    Financial Exhibit
Competing Product    3.7.3(b)
Conducting Party    4.2.3
Deductions    1.108
Development Reconciliation Procedures    4.6.2
Dispute    13.1
Distribution Costs    Financial Exhibit
Divest    3.7.3(c)
DMF    4.4.4
EAP Expenses    Financial Exhibit
Enrollment Event    Schedule 7
EPO    8.2.1
Exchange Act    1.16
Excluded Matters    2.9.3
Execution Date    Preamble
Existing Patents    10.2.1
FCPA    1.90
FFDCA    1.40
Finance Working Group    2.5
First Approval in an Oncology Indication    1.89
First Year    4.1.5(b)
Global Publication Strategy    9.4.1
Headlicense Breach    10.6.5(b)
Health Care Reform Fees    Financial Exhibit
Incomplete Activity    4.1.5(b)
Indirect Taxes    7.6.5
Infinity    Preamble
Infinity Indemnified Parties    11.2
Infinity Sole Inventions    8.1.1
Infringement Claim    8.3.9(a)
Intellikine Mark    8.7.3
IST/IIS Working Group    2.5
IP Working Group    2.5
JAMS    13.1.2
JCC    2.3.1
JDC    2.2.1

 

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Definition

  

Section

JMAC    2.4.1
Joint Inventions    8.1.2
Joint Product Patent Rights    8.2.1(a)
JSC    2.1.2
Launched Products    12.3.13
Manufacturing Working Group    2.5
Marketing Expenses    Financial Exhibit
Marketing Related Materials    12.3.14
Medical Affairs Budget    4.2.2
Medical Affairs Costs    4.2.7
Medical Affairs Plan    4.2.2
Medical Affairs Reconciliation Procedures    4.2.8
Milestone Event    Schedule 7
Milestone Payment    Schedule 7
Mono Product    1.108
Net Profit or Loss    Financial Exhibit
Neutral    13.1.3
Non-Breaching Party    12.2.1
Non-Incurred Amount    4.1.5(b)
Non-Sponsor    4.3.2(b)
On-Going Clinical Study    12.3.12
Other Commercialization Costs    Financial Exhibit
Other Income    Financial Exhibit
Owed Party    7.5.3
Owing Party    7.5.3
Paragraph IV Certification    8.3.2
Patent Challenge    12.2.3
Pharmacovigilance Working Group    2.5
Post-Termination Royalty Term    12.3.7(b)
Prior CDA Effective Date    1.124
Product Trademark Costs    8.7.2(c)(iii)
Profit Reconciliation Procedures    7.2.1
Proposed Publications    9.4.2(b)
Proposed Terms    13.13.2
Publishing Party    9.4.2(b)
Quality Agreement    6.1.3
Recall Expenses    Financial Exhibit
Reconciliation Procedures    7.2.1
Regulatory Working Group    2.5
Regulatory Maintenance Costs    Financial Exhibit
Regulatory Owner    4.4.3(a)
Reimbursable Amounts    7.4.1
Reimbursing Party    4.2.3
Reviewing Party    9.4.2(b)
Right of Reference    4.4.4
Royalty Term    7.3.2

 

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Definition

  

Section

Sales Representative    5.7.1
Segregate    3.7.3(d)
Selling Expenses    Financial Exhibit
Severed Clause    14.6
Shared Development Costs    4.6.1
[**]    7.4.2
[**]    8.3.9(b)
Shared Overage Costs    4.6.1
[**]    8.3.7
[**]    8.2.4
Shared Product Liability Costs    11.4.3
[**]    7.4.2
Sole Inventions    8.1.1
Sponsor    4.3.2(b)
Sublicense    3.6.3
Succeeding Year(s)    4.1.5(b)
Supply Agreements    6.1.1
Supply Price    Financial Exhibit
Support Memorandum    13.13.2
Term    12.1
Termination and Wind-Down Plan    12.3.1
Third Party Claim    11.3.1
Translational Medicine Working Group    2.5
USPTO    8.2.1(a)
Withholding Party    7.6.2
Working Group    2.5

ARTICLE 2.

MANAGEMENT OF COLLABORATIVE ACTIVITIES

2.1. Overview of Collaboration .

2.1.1. Current Status . Prior to the Effective Date, Infinity has initiated Clinical Studies of a Product containing the Licensed Compound. The Parties have agreed to Develop and Commercialize Products in the Field in accordance with the GDP and the Commercialization Plan, as applicable.

2.1.2. Joint Steering Committee . Formation; Purposes and Principles . Within [**] days after the Effective Date, Infinity and AbbVie shall designate their representatives to a joint steering committee (the “ JSC ”), comprised of senior executives, to provide high-level oversight and decision-making regarding the activities of the Parties under this Agreement. The Parties anticipate that the JSC will not be involved in day-to-day implementation of activities under this Agreement. The purposes of the JSC shall be (a) to review and approve the overall global Development, Medical Affairs, Manufacture and Commercialization strategies, plans and budgets by reviewing and approving the GDP, the Medical Affairs Plan and the Commercialization Plans, and to review and oversee the overall global Development, Medical Affairs, Manufacture and

 

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Commercialization activities with respect to the Licensed Compounds and Products pursuant to this Agreement, (b) to oversee the JDC, JCC, JMAC and the Working Groups which report to the JSC, (c) to undertake the specific responsibilities set forth in Section 2.1.3, and (d) in accordance with Section 2.9, to resolve matters on which the JDC, JCC or JMAC are unable to reach consensus.

2.1.3. Specific Responsibilities . In addition to its overall responsibility for the activities under this Agreement, the JSC shall in particular:

(a) review and approve annual updates and amendments to the GDP, including the global regulatory strategy (and amendments and updates thereto) included in the GDP and presented by the JDC;

(b) review and discuss, as necessary, the performance of each Party, or a Party’s Affiliate or Sublicensee, as applicable, in performing the activities under the GDP, the Medical Affairs Plan or the Commercialization Plans, including actual financial results versus budget or plan, compliance with applicable Laws and any agreed-upon standards for conduct of such activities and progress of the Clinical Studies then on-going;

(c) review and approve the initial US Commercialization Plan, including the initial US Commercialization Budget, and any amendments and updates to such US Commercialization Plan and US Commercialization Budget, in each case presented to the JSC by the JCC;

(d) review and approve the initial Ex-US Commercialization Plan and any amendments and updates thereto, in each case presented to the JSC by the JCC;

(e) review and approve the initial Medical Affairs Plan, including the initial Medical Affairs Budget, and any amendments and updates thereto, in each case presented to the JSC by the JMAC;

(f) review and approve the Global Branding Strategy, and any amendments and updates thereto, presented by the JCC;

(g) oversee the Finance Working Group and any other Working Groups that reports into the JSC;

(h) attempt to resolve disputes within the JDC, the JCC, the JMAC, the Finance Working Group or any other Working Group that reports to the JSC; and

(i) perform such other functions as are assigned to it in this Agreement or as appropriate to further the purposes of this Agreement to the extent agreed to in writing by the Parties.

2.2. Joint Development Committee .

2.2.1. Formation; Purposes . Within [**] days after the Effective Date, Infinity and AbbVie shall designate their representatives to a joint development committee (the “ JDC ”), which shall report to the JSC and have responsibility for monitoring and facilitating the overall progress of Development activities under this Agreement with respect to Products in the Field, including oversight of the various budgets and activities.

 

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2.2.2. Specific Responsibilities . In particular, the JDC shall:

(a) oversee and coordinate the on-going transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie to Infinity of AbbVie Know-How, related to the Development of Licensed Compounds and Products so that each Party may undertake Development of Licensed Compounds and Products in accordance with the GDP and this Agreement;

(b) coordinate the activities of the Parties under the GDP and oversee the implementation of the GDP;

(c) to the extent necessary, share planning and budgeting information with the JCC and the JMAC and coordinate with the JCC and JMAC in preparing comprehensive planning and budgeting proposals with respect to the Development, Commercialization, Manufacturing and Medical Affairs Activities of Products in the Field, as applicable;

(d) develop and update, on an annual basis, the proposed global regulatory strategy for the Products in the Field in the Territory, and include such proposed strategy in the GDP, for approval by the JSC in accordance with this Agreement;

(e) on an annual basis, update the GDP, including the Development Budget and the allocation of Development responsibilities between the Parties and present to the JSC for approval proposed amendments to the GDP, including the Development Budget, in accordance with Section 4.1.5;

(f) develop and update, on an annual basis, for inclusion in the GDP, the CMC Development plans and the Manufacturing Plans for the pre-clinical and clinical supply of the Licensed Compound and Products in the Territory;

(g) review and comment on Regulatory Filings relating to the Products in the Field in accordance with Section 4.4;

(h) review and comment on the initial Global Publication Strategy and amendments thereto prepared and presented by the JMAC from time to time in accordance with Section 9.4.1;

(i) oversee the Regulatory Working Group, the Pharmacovigilance Working Group, the Manufacturing Working Group, the IP Working Group, the Translational Medicine Working Group and any other Working Groups that reports to the JDC;

(j) monitor progress and performance of Development activities under this Agreement, including a review of actual financial results versus budget or plan; and

(k) perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement as agreed in writing by the Parties.

 

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2.3. Joint Commercialization Committee .

2.3.1. Formation; Purposes . Within [**] days after the Effective Date, Infinity and AbbVie shall designate their representatives to a joint commercialization committee (the “ JCC ”), which shall report to the JSC and have responsibility for overseeing the implementation of all Commercialization activities under this Agreement with respect to Products in the Field, including oversight of the various budgets and activities.

2.3.2. Specific Responsibilities . In particular, the JCC shall:

(a) oversee and coordinate the on-going transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie to Infinity of AbbVie Know-How, related to the Commercialization of Licensed Compounds and Products so that each Party may undertake Commercialization of Licensed Compounds and Products in accordance with the Commercialization Plans and this Agreement;

(b) oversee the Manufacturing Working Group to ensure that Manufacturing Plans, and related budget information, are incorporated into the applicable Commercialization Plans;

(c) develop and update, on an annual basis, Manufacturing Plans for inclusion in the Commercialization Plans to ensure a reliable commercial supply of the Licensed Compound and Products in the Territory;

(d) coordinate with the JDC with respect to regulatory matters;

(e) coordinate with the JDC with respect to pharmacovigilance matters;

(f) develop and present to the JSC for approval the Global Branding Strategy and updates to such Global Branding Strategy during the Term as necessary;

(g) review and present to the JSC for approval the initial US Commercialization Plan, including the US Commercialization Budget therein and the allocation of Commercialization activities between the Parties, which US Commercialization Plan shall be consistent with the Global Branding Strategy and Section 5.3.1, in accordance with this Agreement and, as appropriate, present to the JSC for review and approval proposed updates and amendments to such US Commercialization Plan, including the US Commercialization Budget included therein;

(h) review and comment on the initial or updated (as applicable) Ex-US Commercialization Plan, and any material amendments to such Ex-US Commercialization Plans, and submit such plans to the JSC for review and approval;

(i) coordinate the activities of the Parties under the US Commercialization Plan and oversee the implementation of the US Commercialization Plan and oversee the implementation of the Ex-US Commercialization Plan;

 

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(j) review each Party’s Commercialization activities in the US and AbbVie’s Commercialization activities in the Ex-US Territory, including a review of actual financial results versus budget or plan;

(k) to the extent necessary, share planning and budgeting information with the JDC and JMAC and coordinate with the JDC and JMAC in preparing comprehensive planning and budgeting proposals with respect to the Development, Manufacture and Commercialization of Products and Medical Affairs Activities in the Field in the US, as applicable;

(l) review and comment upon amendments and updates to the Global Publication Strategy developed and presented by the JMAC in accordance with Section 9.4.1;

(m) oversee the Manufacturing Working Group, Co-Promotion Working Group and any other Working Group that reports to the JCC;

(n) review and approve terms for Co-Promotion of Product in the United States for inclusion in the US Commercialization Plan;

(o) review and update, on an annual basis, pricing, discounting and reimbursement decisions for inclusion in the US Commercialization Plan; and

(p) perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement to the extent agreed in writing by the Parties.

2.4. Medical Affairs Committee .

2.4.1. Formation; Purposes . Within [**] days after the Effective Date, Infinity and AbbVie shall designate their representatives to a joint medical affairs committee (the “ JMAC ”), which shall report to the JSC and have responsibility for overseeing the implementation of all Medical Affairs Activities under this Agreement with respect to Products in the Field and in the Territory.

2.4.2. Specific Responsibilities . In particular, the JMAC shall:

(a) oversee and coordinate the on-going transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie to Infinity of AbbVie Know-How, related to the Medical Affairs Activities with respect to the Licensed Compounds and Products so that each Party may undertake Medical Affairs Activities of Licensed Compounds and Products in accordance with the Medical Affairs Plan and this Agreement;

(b) prepare and present to the JSC for approval the initial Medical Affairs Plan (with input from the JDC and JCC), including the Medical Affairs Budget therein, and the allocation of responsibilities between the Parties and, as appropriate, prepare and present to the JSC for review and approval proposed interim and annual updates and amendments to such Medical Affairs Plan, including the Medical Affairs Budget;

 

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(c) review, approve and manage all Investigator Sponsored Clinical Studies and ensure adherence to the Parties’ corporate policies and all federal/state regulations;

(d) coordinate the activities of the Parties under the Medical Affairs Plan and oversee the implementation of the Medical Affairs Plan;

(e) prepare and approve the Global Publication Strategy (with input from the JDC and JCC) and any amendments thereto;

(f) prepare a MSL Deployment Plan for each of the United States, each Major Market Country and certain other territories or regions in the Territory in accordance with the Medical Affairs Plan;

(g) coordinate Congresses, scientific symposia, and scientific advisory boards;

(h) develop scientific and medical education communication platforms;

(i) provide a forum for and facilitate communications between the Parties with respect to the Medical Affairs Activities for the Licensed Compound and Products;

(j) meet promptly following its formation to discuss Infinity’s ongoing Medical Affairs Activities with respect to the Product and the continuation of such activities until such time as the JMAC establishes the initial Medical Affairs Plan;

(k) oversee the IST/IIS Working Group and any other Working Group that reports to the JMAC;

(l) review each Party’s Medical Affairs Activities under the Medical Affairs Plan including review of actual financial results versus budget or plan; and

(m) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Medical Affairs activities for the Licensed Compound and Products.

2.5. Working Groups . From time to time, the Parties or any Committee may establish a working group (each, a “ Working Group ”) to oversee particular projects or activities. Within thirty (30) days after the Effective Date, Infinity and AbbVie shall designate their representatives to a finance working group (the “ Finance Working Group ”), which shall initially report to the JSC; a medical affairs working group (the “ IST/IIS Working Group ”), which shall initially report to the JMAC; a regulatory working group (the “ Regulatory Working Group ”), a pharmacovigilance working group (the “ Pharmacovigilance Working Group ”), an intellectual property working group (the “ IP Working Group ”), and a translational medicine working group (the “ Translational Medicine Working Group ”), each of which shall initially report to the JDC; a co-promotion working group (the “Co-Promotion Working Group”), which shall report to the JCC; and a manufacturing working group (the “ Manufacturing Working Group ”), which shall report to the JDC for Development-related Manufacturing matters and shall report to the JCC for all matters involving Commercialization-related Manufacturing matters. The Committee to which any

 

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Working Group reports may be reassigned upon approval of the JSC. Each Working Group shall undertake the activities allocated to it herein or delegated to it by the Committee to which it reports. During the process of establishing each Working Group, such Working Group and the Committee to which it reports shall agree regarding which matters such Working Group will resolve on its own and which matters such Working Group will advise the Committee regarding (and with respect to which such advice-specific matters the Committee will resolve); provided , that no Committee or any other Person designated with authority hereunder may delegate to a Working Group any decision-making authority over any matter that has been expressly allocated to a Committee or such Person in Section 2.9, and provided further , that the Parties acknowledge and agree that each Working Group is intended to function primarily in a supporting role providing advice to the Committee to which it reports, but that each Working Group will be best positioned to provide expedited guidance regarding certain operational matters as determined by and subject to the jurisdiction of the Committee to which such Working Group reports. Any dispute arising within a Working Group shall be referred to the Committee to which it reports for resolution.

2.6. Membership . Each Committee and Working Group shall be composed of an equal number of representatives appointed by each of Infinity and AbbVie. Each Committee and Working Group shall be initially comprised of no more than [**] representatives of each Party, or such other number as agreed upon by such Committee. Each individual appointed by a Party as a representative to a Committee or Working Group shall be an employee of such Party, or, other than a representative appointed to the JSC, a contractor to such Party or an employee or contractor of such Party’s Affiliate. Each Party shall appoint at least one representative to each Working Group and shall have the right, but not the obligation, to appoint the same number of representatives to any Working Group as are appointed by the other Party to such Working Group. Each Party may replace any of its Committee or Working Group representatives at any time upon written notice to the other Party which notice may be given by e-mail, sent to the other Party’s co-chairperson of such Committee or Working Group and, with respect to a change of representatives to any Working Group, to the other Party’s co-chairperson of the Committee to which such Working Group reports and, with respect to a change of representatives to the Finance Working Group, to the other Party’s co-chairpersons of the JDC, JCC and JMAC. Each Committee and Working Group shall be co-chaired by one designated representative of each Party. The co-chairperson of each Committee and Working Group shall cast its Party’s vote (or the relevant co-chairperson or Party may designate another representative to cast such vote or, if only one representative of a Party is participating in the relevant meeting of the relevant Committee or Working Group, such representative shall be deemed so designated to cast such Party’s vote) on the respective Committee and Working Group and the co-chairperson or such designee shall have the authority to make decisions on behalf of such Party. The co-chairpersons shall be responsible for (a) calling meetings, (b) preparing and circulating an agenda in advance of each meeting; provided , that the co-chairpersons shall include any agenda items proposed by either Party on such agenda, and (c) preparing and issuing minutes of each meeting within [**] days (or such shorter time as is agreed by the relevant Committee or Working Group) thereafter. For clarity, each Party may designate the same individual as a representative on more than one Committee or Working Group. Each representative of a Party on a Committee or Working Group shall be subject to confidentiality obligations no less stringent than those in ARTICLE 9.

 

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2.7. Meetings of the Committees and Working Groups . Each Committee and Working Group shall hold meetings at such times as such Committee or Working Group shall determine, but in no event shall such meetings of the JSC, JDC, JCC and JMAC be held less frequently than [**] during the Term for so long as each such Committee exists unless the applicable Committee otherwise agrees. A Party may also request that a special meeting of a Committee or Working Group be convened for the purpose of reviewing or making a decision pertaining to any matter within the purview of such Committee or Working Group by providing written notice to the other Party. Such special meeting shall be convened at such time as may be mutually agreed upon by the Parties, but in any event shall be held within [**] days after the date of such notice. Each Committee and Working Group may meet in person or by audio or video conference as its representatives may mutually agree; provided , that the JSC, JDC, JCC and JMAC shall meet in person at least [**] during the Term for so long as such Committee exists, unless the Parties agree otherwise. In-person meetings of a Committee or Working Group shall be held at a location selected by a Party, with the choice alternating between Infinity and AbbVie with respect to each Committee or Working Group. Other representatives of the Parties, their Affiliates and Third Parties involved in the Development, Manufacture or Commercialization of the Products may be invited by the members of a Committee or Working Group to attend meetings of such Committee or Working Group as non-voting observers; provided , that, such representatives are subject to confidentiality obligations no less stringent than those in ARTICLE 9; provided further, that each representative appointed by a Party to take action at a meeting of a Committee or Working Group shall have sufficient authority to execute such action on behalf of such Party. Any Committee or Working Group may upon agreement meet on an ad hoc basis between regularly scheduled meetings in order to address and resolve time-sensitive issues within their purview that may arise from time to time. No action taken at a meeting of a Committee or Working Group shall be effective unless at least one representative of each Party is present or participating. Neither Party shall unreasonably withhold attendance of at least one representative of such Party at any meeting of a Committee or Working Group for which reasonable advance notice was provided. For clarity, Working Groups shall make decisions only to the extent authorized to do so by the Committee to which such Working Group reports to the extent such authorization is within the scope of responsibilities of such Committee. In addition, notwithstanding anything to the contrary in this Section 2.7 or in Sections 2.9, 14.4 or 14.5, any Committee can make a decision within its purview upon written agreement of the co-chairpersons of such Committee, which may include an e-mail chain in which each co-chairperson (or designee described in Section 2.6) agrees to the relevant decision and which e-mail chain includes a courtesy copy to the Alliance Managers and which e-mail chain shall be maintained with the minutes of such Committee.

2.8. Discontinuation of Participation on a Committee . Each Committee and Working Group shall continue to exist until the Parties mutually agree to disband the Committee or Working Group.

2.9. Decision-Making .

2.9.1. Escalation to JSC . In conducting its activities, each Committee and Working Group shall operate and make decisions consistent with the terms of this Agreement. With respect to decisions of each Committee or Working Group, each Party shall have one vote which shall be cast by such Party’s chairperson (or designee described in Section 2.6) on such Committee or Working Group regardless of the number of representatives from each Party. Should any Working Group not be able to reach agreement on any matter that is within its purview under this Agreement and a Party, or its representatives on such Working Group, requests a resolution, the matter shall be

 

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referred to the Committee to which such Working Group reports. Should the JDC, JCC or JMAC not be able to reach agreement on any matter that is within its purview under this Agreement at a meeting of such Committee at which such matter is considered and a Party, or its representatives on such Committee, requests a resolution, the matter shall be referred to the JSC.

2.9.2. Escalation to Executive Officers . Should the JSC not be able to reach agreement within [**] days after the JSC begins considering such matter at a duly called meeting of the JSC, either with respect to any matter referred to it by the JDC or JCC, or with respect to a matter initially arising within the JSC, either Party may refer the matter to the Executive Officers for resolution. The Executive Officers shall attempt to resolve the matter in good faith. If the Executive Officers fail to resolve such matter within [**] Business Days after the date on which the matter is referred to the Executive Officers (unless a longer period is agreed to by the Parties), then such disputes or decisions shall be resolved according to Section 2.9.3.

2.9.3. Final Decision-Making . Should the Executive Officers not be able to reach agreement with respect to any matter referred to them by the JSC pursuant to Section 2.9.2, such matter shall be resolved pursuant to Sections 13.1-13.11, except as follows (the matters described in clauses (a) - (h) below, the “ Excluded Matters ”):

(a) Except where specifically allocated in clauses (b) through (h) of this Section 2.9.3, decisions regarding (i) Development of Products specifically subject to approval by the JDC or JSC under this Agreement, including the global regulatory strategy and Development of Combination Products, (ii) Commercialization of Products specifically subject to approval by the JCC or JSC under this Agreement, including Commercialization of Combination Products, subject to Section 4.1.6, (iii) Medical Affairs Activities regarding Products specifically subject to approval by the JMAC or JSC under this Agreement, (iv) Research activities with respect to the Licensed Compound, and (v) whether or not an AbbVie Withholding Tax Action represents the only commercially reasonable alternative to Commercialize a Product shall in each case ((i) through (v)) require mutual agreement of the Parties (or the Parties’ respective representatives on the applicable Committee). If the Parties are unable to mutually agree upon any such matter, then neither Party shall have the right to resolve the matter over the objection of the other Party, the matter shall remain unresolved unless and until agreed upon by the JSC, and shall not be subject to resolution pursuant to ARTICLE 13;

(b) Except where specifically allocated to a Party in clauses (c) through (h) of this Section 2.9.3, decisions regarding (i) the Global Branding Strategy, (ii) the US Commercialization Plan, including the US Commercialization Budget (iii) the Sales Force Deployment Plan, and (iv) the MSL Deployment Plan for the Territory shall be resolved pursuant to Section 13.13.

(c) AbbVie’s Executive Officer shall have the deciding vote with respect to the following Commercialization matters to the extent related to the US Commercialization Plan in the US Territory, consistent with the Global Branding Strategy: (i) the promotional and educational materials for the Product; (ii) Sales Representative training materials related to the Product; (iii) managed care pricing activities and contracting, including final managed care pricing decisions consistent with each of the following: the established Product list price, targeted net pricing, sales-weighted average discounts and rebates, and pricing strategy (including, without limitation, the approach to pricing with different types of accounts and plans, including types of discounts and rebates) and (iv) HECOR;

 

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(d) Infinity’s Executive Officer shall have the deciding vote with respect to the following Commercialization matters to the extent related to the US Commercialization Plan in the US Territory, consistent with the Global Branding Strategy: (i) distribution and patient services, (ii) contracting with advertising agencies and public relations firms, (iii) Product list price, targeted net pricing, sales-weighted average discounts and rebates, pricing strategy (including, without limitation, the approach to pricing with different types of accounts and plans, including types of discounts and rebates) and modifications to any of the foregoing, and (iv) commercial advisory boards;

(e) With respect to Medical Affairs Activities, (i) if such activities relate to the support of a Clinical Study under the GDP, the Executive Officer of the Party conducting such study will have the deciding vote with respect to such support activities on a global basis, including the publication of data resulting from such Clinical Study consistent with the Global Publication Strategy, (ii) AbbVie’s Executive Officer will have the deciding vote with respect to (A) approval, funding and other support for Investigator Sponsored Clinical Studies which include AbbVie Combination Compound in the US Territory, including publication of the resulting data, (B) all Investigator Sponsored Clinical Studies in the Ex-US Territory, including publication of the resulting data, (C) physician education activities under the Medical Affairs Plan and (D) medical affairs support of managed care activities and (iii) Infinity’s Executive Officer will have the deciding vote with respect to (A) subject in all respects to Section 4.2.3, approval, funding and other support for all Investigator Sponsored Clinical Studies in the US Territory other than Investigator Sponsored Clinical Studies which include AbbVie Combination Compound, including publication of the resulting data and (B) development advisory boards (unless specific to a Clinical Study, in which case the Executive Officer of the Party conducting such study will have the deciding vote) and (C) Global Publication Strategy;

(f) AbbVie’s Executive Officer will have the deciding vote with respect to the Ex-US Commercialization Plan;

(g) AbbVie’s Executive Officer will have the deciding vote with respect to all matters relating to or involving the AbbVie Combination Compound (other than as to any Combination Product comprising the Abbvie Combination Compound and the Licensed Compound as set forth in Section 5.5.5) and, should Abbvie obtain the right to conduct such Clinical Studies pursuant to Section 4.1.6, the Clinical Studies that include the AbbVie Combination Compound, including companion diagnostics for the AbbVie Combination Compound or a combination of the Licensed Compound and the AbbVie Combination Compound, all of which such Clinical Studies shall nonetheless be set forth in the GDP, subject to approval of the JDC, and governed by Section 2.9.3(a); and

(h) Infinity’s Executive Officer shall have the deciding vote on all clinical and commercial Manufacturing-related matters until the Parties transition Manufacturing responsibility to AbbVie pursuant to Section 6.1.1, after which transition AbbVie’s Executive Officer shall have the deciding vote on all Manufacturing-related matters.

 

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2.9.4. Limitations .

(a) For clarity, any decision that is specified in this Agreement to be made by a Party or by both Parties (i.e., rather than by a Committee or a Working Group), including matters expressly subject to the mutual agreement of the Parties, shall not be subject to resolution by a Committee or Working Group or pursuant to ARTICLE 13.

(b) Notwithstanding anything to the contrary in Section 2.9.3, no Committee or Working Group shall have the authority to amend this Agreement.

(c) Notwithstanding anything to the contrary in Section 2.9.3, neither Party shall exercise its right to finally resolve a matter pursuant to Section 2.9.3: (i) in a manner that excuses such Party from any of its obligations specifically enumerated under this Agreement or any Related Agreement; (ii) in a manner that negates any consent rights or other rights specifically allocated to the other Party under this Agreement or any Related Agreement; (iii) in a manner that would cause the other Party to breach an Infinity Third Party Agreement or AbbVie Third Party Agreement, as applicable, to require any Third Party counterparty to any such Third Party agreement to take any actions not required to be performed by such Third Party under such Third Party agreement; (iv) in a manner that would require the other Party to perform any act that it reasonably believes to be inconsistent with any Law or any approval, order, policy or guidelines of a Regulatory Authority and the relevant Party shall promptly provide notice of such belief to the other Party; or (v) in a manner that would infringe or misappropriate a Third Party’s Patent Rights, Know-How or trademark rights. In addition, in resolving a dispute pursuant to Section 2.9.3, the deciding Party shall act in good faith.

2.10. Alliance Managers . Within [**] days after the Effective Date, each Party shall designate a single alliance manager for all of the activities contemplated under this Agreement (each, an “ Alliance Manager ”). Each Party’s Alliance Manager may attend all meetings of each Committee or Working Group as a non-voting participant. The Alliance Managers will be responsible for the day-to-day worldwide coordination of the Parties’ activities under this Agreement, will serve to facilitate communication between the Parties, will serve as a first point of contact as it relates to resolution of any dispute in accordance with the procedures outlined herein. The Alliance Managers shall have a general understanding of Development and Commercialization and knowledge appropriate for managers with such alliance management responsibilities. Each Party may change its designated Alliance Manager from time to time upon notice to the other Party.

ARTICLE 3.

LICENSE GRANTS

3.1. Infinity Grants .

3.1.1. Development License . Subject to the terms and conditions of this Agreement, Infinity hereby grants to AbbVie a co-exclusive (with Infinity, solely to the extent set forth in Section 3.1.5) license under the Infinity Intellectual Property to Develop and have Developed the Licensed Compounds and Products in the Field in the Territory, in accordance with the GDP, which license shall be sublicensable to the extent set forth in Section 3.6.

 

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3.1.2. Manufacturing License . Subject to the terms and conditions of this Agreement, Infinity hereby grants to AbbVie a co-exclusive (with Infinity, solely to the extent set forth in Section 3.1.5) license under the Infinity Intellectual Property to Manufacture and have Manufactured the Licensed Compounds and Products in the Field for use or sale in the Territory in accordance with this Agreement and any Supply Agreement, which license shall be sublicensable to the extent set forth in Section 3.6.

3.1.3. Commercialization License . Subject to the terms and conditions of this Agreement, Infinity hereby grants to AbbVie (a) a co-exclusive license (with Infinity, solely to the extent set forth in Section 3.1.5) under the Infinity Intellectual Property to Commercialize Products in the Field in the US Territory in accordance with the US Commercialization Plan, and (b) an exclusive license, even as to Infinity, under the Infinity Intellectual Property to Commercialize Products in the Field in the Ex-US Territory in accordance with the Ex-US Commercialization Plan, which license shall be sublicensable to the extent set forth in Section 3.6.

3.1.4. Trademark License . Subject to the terms and conditions of this Agreement, Infinity hereby grants to AbbVie a royalty-free, fully paid up, co-exclusive (with Infinity, solely to the extent set forth in Section 3.1.5), license to use the Product Trademarks and Internet domain names described in Section 8.7.2 and owned by Infinity, solely for the purposes of conducting Development activities with respect to the Products in the Field in the Territory in accordance with the GDP and Commercializing the Products in the Field in the Territory in accordance with the applicable Commercialization Plan, which license shall be sublicensable to the extent set forth in Section 3.6.

3.1.5. Retained Rights; Bankruptcy Code § 365(n) Election . Subject to the terms and conditions of this Agreement, with respect to each license granted pursuant to Sections 3.1.1 through 3.1.4, Infinity shall retain the right, itself or through its Affiliates, subcontractors or Sublicensees, solely to perform those activities (if any) to the extent allocated to Infinity, and exercise Infinity’s rights, under this Agreement, the GDP, the Medical Affairs Plan, the US Commercialization Plan and any Related Agreement, or as requested by AbbVie or its Affiliate. AbbVie’s licenses granted pursuant to Sections 3.1.1, 3.1.3 and 3.1.4 are limited to the conduct of only those activities which, as of such time, are assigned to AbbVie under the GDP or any Commercialization Plan; provided that, following any rejection of this Agreement or any Related Agreement by Infinity and election by AbbVie to retain its license rights hereunder pursuant to Bankruptcy Code § 365(n), AbbVie shall have the right to perform all activities otherwise allocated as of such time to Infinity, it being understood that such reallocation of activities shall not change or disturb the royalty payments, if any, payable to Infinity pursuant to Bankruptcy Code § 365(n). Following any such rejection and election by AbbVie, and notwithstanding Section 2.9.3 hereof, AbbVie shall have the right to amend the GDP, the Medical Affairs Plan or any Commercialization Plan without the need to propose any such amendment to any Committee hereunder and without the need to obtain any agreement or consent of Infinity hereunder, and may otherwise exercise its rights under the licenses granted in Sections 3.1.1 through 3.1.4 consistent with the scope of the licenses granted under those Sections.

 

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3.1.6. Third Party Rights . Notwithstanding anything to the contrary herein, the rights, licenses and sublicenses granted by Infinity to AbbVie in this Agreement or any Related Agreement are subject to the terms and conditions of the applicable Infinity Third Party Agreements, and the rights granted to or retained by the counterparties thereunder or their licensors.

3.2. AbbVie Grants .

3.2.1. Development License . Subject to the terms and conditions of this Agreement, AbbVie hereby grants to Infinity a co-exclusive (with AbbVie, solely to the extent set forth in Section 3.2.5) license under the AbbVie Intellectual Property to Develop and have Developed the Licensed Compounds and Products in the Field in the Territory, in accordance with the GDP, which license shall be sublicensable to the extent set forth in Section 3.6.

3.2.2. Manufacturing License . Subject to the terms and conditions of this Agreement, AbbVie hereby grants to Infinity a co-exclusive license (with AbbVie, solely to the extent set forth in Section 3.2.5) under the AbbVie Intellectual Property to Manufacture and have Manufactured the Licensed Compounds and Products in the Field for use or sale in the Territory in accordance with this Agreement and any Supply Agreements, which license shall be sublicensable to the extent set forth in Section 3.6.

3.2.3. Commercialization License . Subject to the terms and conditions of this Agreement, AbbVie hereby grants to Infinity a co-exclusive (with AbbVie, solely to the extent set forth in Section 3.2.5) license under the AbbVie Intellectual Property to Commercialize Products in the Field in the US Territory in accordance with the US Commercialization Plan, which license shall be sublicensable to the extent set forth in Section 3.6.

3.2.4. [**]. Subject to the terms and conditions of this Agreement, AbbVie hereby grants to Infinity a [**] to make, have made, import, export, use, have used, sell, have sold, or offer for sale, including to develop, commercialize, register, modify, enhance, improve, manufacture, have manufactured, hold, or keep (whether for disposal or otherwise), or otherwise dispose of [**].

3.2.5. Retained Rights; Bankruptcy Code § 365(n) Election . Subject to the terms and conditions of this Agreement, with respect to each license granted pursuant to Sections 3.2.1 through 3.2.4, AbbVie shall retain the right, itself or through its Affiliates, subcontractors or Sublicensees, solely to perform such activities (if any) to the extent allocated to AbbVie, and exercise AbbVie’s rights, under this Agreement, the GDP, the Medical Affairs Plan, each Commercialization Plan and any Related Agreement, or as requested by Infinity or its Affiliate. Infinity’s Exploitation of the licenses granted pursuant to Section 3.2.1 through Section 3.2.4 are limited to the conduct of only those activities which, as of such time, are assigned to Infinity under the GDP or any Commercialization Plan; provided that, following any rejection of this Agreement or any Related Agreement by AbbVie and election by Infinity to retain its license rights hereunder pursuant to § 365(n), Infinity shall have the right to perform all activities otherwise allocated as of such time to AbbVie, it being understood that such reallocation of activities shall not change or disturb the royalty payments, if any, payable to AbbVie pursuant to Bankruptcy Code § 365(n). Following any such rejection and election by Infinity, and notwithstanding Section 2.9.3 hereof, Infinity shall have the right to amend the GDP, the Medical Affairs Plan or any Commercialization Plan without the need to propose any such amendment to any Committee hereunder and without the need to obtain any agreement or consent of AbbVie hereunder, and may otherwise exercise its rights under the licenses granted in Sections 3.2.1 through 3.2.4 consistent with the scope of the licenses granted under those Sections; provided that, Infinity shall in no instance have the right to conduct any Clinical Studies involving the AbbVie Combination Compound.

 

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3.3. Provision of Information . During the Term, each Party will make available to the other Party all Regulatory Filings and Infinity Know-How or AbbVie Know-How, as applicable, in its possession or Control related to the Licensed Compound or the Product as reasonably necessary or useful to Develop, Manufacture and Commercialize the Licensed Compound or the Product under this Agreement.

3.4. Joint Patent Rights . Subject to the provisions of Sections 3.1, 3.2 and 3.7, and to the extent not already granted herein, each Party hereby grants, and shall cause its Affiliates to grant, to the other Party a worldwide, non-exclusive, royalty-free, fully paid up, freely sublicensable right and license to exploit the Joint Patent Rights in any manner without compensating or accounting to the other Party (or its Affiliates).

3.5. Blocking Third Party Intellectual Property .

3.5.1. Certain Blocking Third Party Intellectual Property. If, during the Term, a Party believes, in its reasonable judgment, that it may be necessary to obtain rights under any Blocking Third Party Intellectual Property in order to Develop, Manufacture or Commercialize a Product in the Field in accordance with this Agreement, said Party shall promptly call a meeting of the IP Working Group, and the Parties, through the IP Working Group, shall discuss such matter, including whether a license under such Blocking Third Party Intellectual Property would be necessary.

(a) If the IP Working Group [**] in accordance with this Agreement or the IP Working Group [**], and the IP Working Group [**], the [**] shall use Diligent Efforts to obtain a sublicensable license under, or acquire, such Blocking Third Party Intellectual Property from the relevant Third Party, and, in connection with obtaining such a license to or acquiring such Blocking Third Party Intellectual Property, [**] will, where possible, provide to [**] drafts of any such license or acquisition agreement reasonably in advance of providing such drafts to the applicable Third Party and will incorporate all reasonable comments [**] in such draft.

(b) If the IP Working Group [**], then [**] shall have the right to do so for this Product, in which case Section 3.5.2 would apply to such rights and [**] shall use diligent efforts to [**].

(c) If the IP Working Group [**], but the IP Working Group [**] then [**], to obtain a sublicensable license under, or acquire, such Blocking Third Party Intellectual Property from the relevant Third Party and, [**] licenses or acquires such rights, and the costs incurred [**] under such license or for such acquisition shall be allocated as described in sub-section (e) below. If [**] elects not to obtain such a license or is unable to obtain such a license, [**], to obtain a sublicensable license under, or acquire, such Blocking Third Party Intellectual Property from the relevant Third Party, and the costs incurred [**] under such license or for such acquisition shall be allocated as described in sub-section (e) below.

 

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(d) If Infinity licenses or acquires such rights under this Section 3.5.1, (i) Infinity’s (or its relevant Affiliate’s) agreement(s) with such Third Party with respect to such Blocking Third Party Intellectual Property shall be considered Infinity Third Party Agreement(s), (ii) Infinity shall promptly provide a copy of such Infinity Third Party Agreement(s) to AbbVie, (iii) the Blocking Third Party Intellectual Property Controlled by Infinity as a result of such Infinity Third Party Agreement(s) shall be considered Infinity Intellectual Property, (iv) all rights and obligations under this Agreement with respect to such Infinity Intellectual Property shall be subject to such Infinity Third Party Agreement(s) and (v) any payments with respect thereto shall be considered Infinity Third Party Agreement Payments. If AbbVie licenses or acquires such rights under this Section 3.5.1, (v) AbbVie’s (or its relevant Affiliate’s) agreement(s) with such Third Party with respect to such Blocking Third Party Intellectual Property shall be considered AbbVie Third Party Agreement(s), (w) AbbVie shall promptly provide a copy of such AbbVie Third Party Agreement(s) to Infinity, (w) such Blocking Third Party Intellectual Property shall be considered AbbVie Intellectual Property, (x) all rights and obligations under this Agreement with respect to such AbbVie Intellectual Property shall be subject to such AbbVie’s Third Party Agreement(s), (y), and (z) [**].

(e) All Infinity Third Party Agreement Payments and Blocking Third Party Intellectual Property Costs that arise out of the Development or Commercialization of any Licensed Compound or Product under this Agreement, in either case that are incurred by Parties that relate solely to the US Territory (e.g., royalties on sales in the US Territory or milestone payments for events in the US) will be included in Allowable Expenses and shared between the Parties accordingly, and the IP Working Group will determine [**]. The [**] determined by the IP Working pursuant to the preceding sentence will be included in Allowable Expenses or reimbursed accordingly. In the event that the IP Working Group is unable to reach agreement [**], the matter shall be referred to a [**], each Party shall provide to such Third Party all information in its control necessary for such Third Party to resolve such matter, and [**]. AbbVie shall reimburse Infinity for all Infinity Third Party Agreement Payments that relate to the Ex-US Territory that Infinity incurs pursuant to Section 7.4.1, except that, for clarity, Infinity shall be solely responsible for all royalty payments arising under an Existing Infinity Third Party Agreement as a result of the sale of Products in the Ex-US Territory by AbbVie or its Affiliates or Sublicensees. Schedule 3.5.1 sets forth all non-royalty payments under Existing Infinity Third Party Agreements not yet paid by Infinity as of the Effective Date. The Finance Working Group shall ensure that the necessary information and payments are received by a Party from the other Party sufficiently in advance of the date(s) on which such information and payments are due to the relevant Third Party counterparty under an Infinity Third Party Agreement or AbbVie Third Party Agreement to avoid a breach of such Infinity Third Party Agreement or AbbVie Third Party Agreement. All Blocking Third Party Intellectual Property Costs incurred by AbbVie that relate solely to the US Territory will be included in Allowable Expenses and shared between the Parties accordingly. Blocking Third Party Intellectual Property Costs (including payments under AbbVie Third Party Agreements and Infinity Third Party Agreement Payments pursuant to Section 3.5) for the Ex-US Territory that are reimbursed by AbbVie shall be deducted and recouped from royalties owed to Infinity in accordance with Section 7.3.3(d).

(f) If the Party other than the Party that acquires or obtains a license pursuant to this Section 3.5.1 under Blocking Third Party Intellectual Property determines that such Blocking Third Party Intellectual Property Covers one or more technologies or products that are not Products, [**], the Parties shall [**]; provided, however, that the [**], the Parties shall [**] this Agreement.

 

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3.5.2. [**] Third Party Blocking Intellectual Property . If, during the Term, a Party obtains rights under any Blocking Third Party Intellectual Property (by in-license, acquisition or otherwise) [**] in accordance with this Agreement, said Party shall promptly call a meeting of the IP Working Group [**], provide a summary of material terms with respect to such Blocking Third Party Intellectual Property, and the Parties, through the IP Working Group, [**]. If the IP Working Group determines that it would be [**], the Party that has obtained rights to such Block Third Party Intellectual Property will provide a copy of the agreement pursuant to which such Party has obtained such rights to the other Party to the extent permitted by such agreement.

(a) If the IP Working Group determines that such Blocking Third Party Intellectual Property [**] and such use of such Blocking Third Party Intellectual Property with respect to a Product would give rise to any payments to a Third Party in consideration for such use, then such Blocking Third Party Intellectual Property [**]. If no such payments would arise in connection with the use of the Blocking Third Party Intellectual Property with a Product, then such Blocking Third Party Intellectual Property [**].

(b) In the event that the IP Working Group determines [**], the matter shall be referred to a mutually agreed upon Third Party expert in the valuation of life sciences assets, who shall determine [**]. Each Party shall provide to such Third Party all information in its control necessary for such Third Party to resolve such matter, and the costs for such expert shall be borne equally by the Parties.

3.5.3. [**].

3.6. Sublicensing and Subcontracting .

3.6.1. AbbVie Right to Sublicense . AbbVie shall have the right to grant sublicenses (through multiple tiers) to its Affiliates or Third Parties of any and all rights granted to AbbVie under this Agreement by Infinity pursuant to Section 3.1 or licenses to its Affiliates or Third Parties of rights retained by AbbVie with respect to Licensed Compounds and Products in the Field. If AbbVie grants any sublicense pursuant to this Section 3.6.1, AbbVie shall remain responsible for its obligations under this Agreement and shall be responsible for the performance of the relevant Sublicensee. In addition, AbbVie shall ensure that each of its Sublicensees complies with all relevant provisions of this Agreement.

3.6.2. Infinity Right to Sublicense . Infinity shall have the right to grant sublicenses (through multiple tiers) to its Affiliates or Third Parties of any and all rights granted to Infinity under this Agreement by AbbVie pursuant to Section 3.2 or licenses to its Affiliates or Third Parties of rights retained by Infinity with respect to Licensed Compounds and Products in the Field. If Infinity grants any sublicense pursuant to this Section 3.6.2, Infinity shall remain responsible for its obligations under this Agreement and shall be responsible for the performance of the relevant Sublicensee. In addition, Infinity shall ensure that each of its Sublicensees complies with all relevant provisions of this Agreement.

3.6.3. Sublicense Requirements . Each license or sublicense granted by a Party to an Affiliate or a Third Party (including any subcontractor) pursuant to Section 3.6.1 or 3.6.2 (a “ Sublicense ”) shall be in writing and shall be consistent with the relevant restrictions and limitations set forth in this Agreement. No Sublicense or subcontract shall diminish, reduce or eliminate any obligation of either Party under this Agreement.

 

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3.7. Exclusivity Covenants .

3.7.1. Infinity Covenant .

(a) During the Term, except pursuant to and in accordance with the terms of this Agreement or any Related Agreement, neither Infinity nor any of its Affiliates (subject to Section (b)) shall directly or indirectly (i) Commercialize any Competing Product in the Field in the Territory, nor collaborate with, license, sell to or enable or otherwise authorize, permit or grant any right to any Third Party to Commercialize any Competing Product in the Field in the Territory; (ii) Develop the Licensed Compound or Product outside of the Field beyond the completion of Phase II Studies (or beyond Phase I Studies if it is contemplated that such Phase II Studies will or may be used as pivotal, registration directed studies); or (iii) Commercialize the Licensed Compound or Products outside the Field in the Territory, nor collaborate with, license, sell to or enable or otherwise authorize, permit or grant any right to any Third Party to Commercialize the Licensed Compound or Products outside the Field in the Territory.

(b) Notwithstanding the provisions of Section 3.7.1(a), if, during the Term, (i) Infinity or any of its Affiliates acquires, as the result of an Acquisition Transaction (other than a Change of Control), rights to a Competing Product, [**]; or (ii) Infinity undergoes a Change of Control and the relevant acquirer is either then Commercializing a Competing Product in the Field or has in development any Competing Product in the Field, such Acquisition Transaction, and the Commercialization (or development and subsequent Commercialization, if such Competing Product is approved) of such Competing Product in the Field by such relevant acquirer or any of its Affiliates, [**]. If following an Acquisition Transaction that is not a Change of Control, [**].

3.7.2. AbbVie Covenant .

(a) During the Term, except pursuant to and in accordance with the terms of this Agreement or any Related Agreement, neither AbbVie nor any of its Affiliates shall directly or indirectly Commercialize any Competing Product in the Field in the Territory, nor collaborate with, license, sell to, enable or otherwise authorize, permit or grant any right to any Third Party to Commercialize any Competing Product in the Field in the Territory.

(b) Notwithstanding the provisions of Section 3.7.2(a), if, during the Term, (i) AbbVie or any of its Affiliates acquires, as the result of an Acquisition Transaction (other than a Change of Control), rights to a Competing Product such Acquisition Transaction, and [**]; or (ii) if AbbVie undergoes a Change of Control and the relevant acquirer is either then Commercializing a Competing Product in the Field, or has in development any Competing Product in the Field, such Acquisition Transaction, and the Commercialization (or development and subsequent Commercialization, if such Competing Product is approved) of such Competing Product in the Field by such acquiring Affiliate, [**]. If following an Acquisition Transaction that is not a Change of Control, [**].

 

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3.7.3. Definitions . As used in this Section 3.7,

(a) “ Acquisition Transaction ” means (i) a Change of Control of a Party, (ii) any acquisition of all or substantially all of the assets of a Third Party relating to a Competing Product, or the acquisition of control (as defined in Section 1.10) of a Third Party, or (iii) a merger or consolidation of a Party with or of a Third Party that is not a Change of Control of such Party;

(b) “ Competing Product ” means [**];

(c) “[**]” means (i) [**]; and

(d) “[**]” means, with respect to a Competing Product, [**].

3.7.4. Section 365(n) of the Bankruptcy Code . All rights and licenses granted under or pursuant to any section of this Agreement, including Section 3.1, are rights to “intellectual property” (as defined in Section 101(35A) of Title 11 of the United States Code (the “ Bankruptcy Code ”)) and the Parties hereby acknowledge, on behalf of themselves and their respective Affiliates, that such “intellectual property” includes (a) laboratory samples, (b) Product samples and inventory, (c) laboratory notes and notebooks, (d) Data and results related to Clinical Studies, (e) Regulatory Filings and Regulatory Approvals, (f) rights of reference in respect of Regulatory Filings and Regulatory Approvals, and (g) marketing, advertising and Promotional Materials. The Parties agree that each Party, as a licensee of such rights under this Agreement, will retain and may fully exercise all of its rights and elections under the Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against either Party under the Bankruptcy Code, then the Party that is not a party to such proceeding will be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, and the same, if not already in its possession, will be promptly delivered to it (y) upon any such commencement of a bankruptcy proceeding upon written request therefor, if such Party subject to such proceeding fails to perform all of its obligations under this Agreement and the Related Agreements, or (z) if not delivered under subsection (y) above, following the rejection of this Agreement by or on behalf of the Party subject to such proceeding upon written request therefor by the non-subject Party, and, with respect to clauses (y) or (z), the “royalty payments” due with respect to the United States from AbbVie as the non-subject Party in accordance with Section 365(n) of the Bankruptcy Code shall be fifty percent (50%) of the Net Profit or Loss, and the “royalty payments” due with respect to the United States from Infinity as the non-subject Party in accordance with Section 365(n) of the Bankruptcy Code shall be fifty percent (50%) of the Net Profit or Loss; provided that, for purposes of calculating such royalty payments in accordance with Section 365(n) of the Bankruptcy Code, fifty percent (50%) of any Net Profits or Loss, to the extent less than zero and not reconciled and paid in any Calendar Quarter pursuant to Section 7.2.2, shall be credited against any such royalty payments owed to the other Party following any such Calendar Quarter.

3.8. Reservation of Rights .

3.8.1. No rights, other than those expressly set forth in this Agreement are granted to either Party hereunder, and no additional rights shall be deemed granted to either Party by implication, estoppel or otherwise, with respect to any intellectual property rights. All rights not expressly granted by either Party or its Affiliates to the other hereunder are reserved.

 

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3.8.2. Infinity agrees not to practice any AbbVie Intellectual Property except pursuant to the licenses expressly granted to Infinity in this Agreement (it being agreed that no such license grants any right to Research any compound or product, or to Develop, have Developed, Manufacture, have Manufactured, use, sell, offer to sell, otherwise Commercialize or import any compounds and products containing or comprising any compound, other than Licensed Compounds and Products in the Field to the extent set forth herein).

3.8.3. AbbVie agrees not to practice any Infinity Intellectual Property except pursuant to the licenses expressly granted to AbbVie in this Agreement (it being agreed that no such license grants any right to Research any compound or product, or to Develop, have Developed, Manufacture, have Manufactured, use, sell, offer to sell, otherwise Commercialize or import any compounds and products containing or comprising any compound, other than Licensed Compounds and Products in the Field to the extent set forth herein).

ARTICLE 4.

DEVELOPMENT

4.1. GDP; Amendments; Development Responsibilities .

4.1.1. Global Development Plan . The global Development of the Products shall be governed by the GDP, and the Parties agree to conduct all of their (and their Affiliates’) Development activities relating to the Products in accordance with the GDP. The initial approved GDP is attached hereto as Exhibit C . The GDP shall include, with respect to the Licensed Compound and Products, the strategy for global Development and for obtaining Regulatory Approval, guidelines for additional data or criteria, high-level study design criteria, e.g. indication, line of therapy, approximate patient numbers, primary trial endpoints (it being understood that the Party conducing a Clinical Study shall have final decision-making authority with respect to decisions regarding the implementation of such Clinical Study on matters such as investigator and site selection consistent with the GDP) if any, to be generated for assessment prior to Commencement of any specific Clinical Study, allocation of responsibilities between the Parties, timelines, the Development Budget, translational medicine activities, and thought leader activities, (it being understood that the initial GDP does not include all of the requirements set forth in this Section 4.1.1). The GDP shall be consistent with the terms of this Agreement and shall be sufficient to permit Infinity to comply with its obligations under each of the Infinity Third Party Agreements. The activities set forth in the GDP shall at all times be designed to be in compliance with all applicable Laws. Each GDP shall include a mutually agreed upon, rolling plan for Developing the Products and shall be prepared in good faith. The Parties agree to pursue in good faith and fund the Development Costs of any Clinical Study set forth in the GDP to the extent required under this Agreement, regardless of the Calendar Year in which such Clinical Study Commences.

4.1.2. Development Principles . The Development of Products in the Field will be conducted in accordance with the following principles, except to the extent (if any) otherwise expressly provided in the GDP, and the JDC (or the JSC, or the Executive Officers, as applicable) shall take into account and attempt to implement the following principles in its decision-making, including preparation, review and approval of any updates to and amendments of the GDP:

 

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(a) Regardless of the specific division of responsibility between the Parties for particular activities at any particular time, the JDC shall serve as a conduit for sharing information, knowledge and expertise relating to the Development of the Product;

(b) Clinical development of, and translational medicine for, Licensed Compounds and Products should be performed only in accordance with the GDP; and

(c) The Parties shall cooperate (and cause their Affiliates and use Diligent Efforts to cause any Sublicensees to cooperate) to facilitate the on-going transfer between the Parties of Infinity Know-How or AbbVie Know-How to allow both Parties (or their Affiliates) to use such Know-How in the Development and Manufacturing of Licensed Compounds and Products in accordance with this Agreement and the Related Agreements, as applicable.

4.1.3. Development Budget . The Development Budget shall set forth the budgeted amounts for Development Costs with respect to activities allocated to the Parties under the GDP [**] thereafter and shall include for each Party a budget for Development Costs for the Development activities allocated to such Party for such period, broken down by Calendar Quarter with respect to the then-current Calendar Year. The Development Budget shall also include a breakout of costs by functional area or category as determined by the JDC. Concurrently with the annual update of the GDP in accordance with Section 4.1.5, the JDC shall prepare, and the JSC shall review and approve the updated Development Budget included in such GDP.

4.1.4. Allocation of Development Activities .

(a) Subject to Section 4.1.6, the GDP shall allocate responsibility between the Parties for the conduct of Clinical Studies and the various other Development activities addressed in the GDP.

(b) The Party that has responsibility for conducting the Clinical Study shall have the responsibility for the packaging of clinical drug supplies, unless otherwise agreed by the Parties.

(c) Neither Party nor its Affiliates shall conduct any Clinical Study or other Development of any Licensed Compound or Product in the Field, except as expressly permitted in this ARTICLE 4.

4.1.5. Updating and Amending the GDP .

(a) The JDC shall review the GDP, including the Development Budget, not less frequently than annually and shall develop detailed and specific GDP updates in accordance with Section 4.1.1. The JDC shall meet no later than [**] of each Calendar Year to prepare the updates to the GDP, and shall submit all such updates to the JSC for review and approval, such that JSC preliminary approval would occur no later than [**] of each Calendar Year. Upon the JSC’s preliminary approval, such updates shall be submitted to each Party for its internal budgeting process with a target for final approval by the JSC no later than [**] of such Calendar Year, at which time the GDP shall be amended accordingly. If the JSC does not approve an updated GDP, including the Development Budget, prior to the start of the next Calendar Year, either Party may initiate procedures to resolve the issue pursuant to Section 2.9, and the

 

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then-current GDP and Development Budget shall continue to apply until the updated GDP is approved by the JSC. The JDC may also develop and submit to the JSC from time to time other proposed amendments to the GDP. The JSC shall review proposed amendments presented to the JDC and may approve such proposed amendments or any other proposed amendments that the JSC may consider from time to time in its discretion, and, upon such approval by the JSC, the GDP shall be amended accordingly.

(b) This Section 4.1.5(b) shall be subject in its entirety to Section 4.1.1: If, during any Calendar Year (the “ First Year ”), any Development activity expressly provided for in the GDP to be completed during such First Year is not completed during such First Year (to the extent incomplete, an “ Incomplete Activity ”) and the full expense budgeted in the Development Budget for such activity for such First Year is not incurred (to the extent not incurred, a “ Non-Incurred Amount ”), then such Incomplete Activity shall be completed during Calendar Years following such First Year (the “ Succeeding Year(s) ”) and the Non-Incurred Amount shall be included in the Development Budget for such Succeeding Year(s) as follows: If the Development Budget for such Succeeding Year(s) has not yet been approved by the JSC, then the Non-Incurred Amount shall be included in the proposed Development Budget for such Succeeding Year(s) without otherwise limiting any other Development activities or any amounts related thereto, unrelated to the Incomplete Activity, which, pursuant to the GDP, would have been performed during such Succeeding Year(s), and if the Development Budget for such Succeeding Year(s) has been approved by the JSC, then the Development Budget for such Succeeding Year(s) shall be revised automatically to include the Non-Incurred Amount.

4.1.6. Combination Clinical Studies .

(a) AbbVie shall be solely responsible for conducting the Clinical Studies provided for in the GDP that involve or relate to the AbbVie Combination Compound. AbbVie shall conduct such Clinical Studies only to the extent AbbVie is able to do so without violating the terms of any AbbVie Third Party Agreement, and, in such case, subject to the terms and conditions of such AbbVie Third Party Agreement. [**]; provided, however, that AbbVie shall have no obligation to (i) [**], (ii) [**], or (iii) [**].

(b) [**].

(c) [**], then the Parties shall [**] shall have [**] shall have [**] and shall not be a[**] under this Agreement [**] and shall be [**], provided, that [**] shall use [**] as of the Effective Date. Notwithstanding the foregoing, if [**].

(d) [**] nothing in this Agreement would prohibit Infinity from conducting such study on its own outside of the scope of the GDP and this Agreement following Regulatory Approval of the AbbVie Combination Compound, without limiting the provisions governing the Licensed Compound herein, (including the exclusivity covenants contained in Section 3.7); provided , that before Infinity Commences such study, [**]. If Infinity conducts such a study, Infinity shall have final decision -making authority with respect thereto, and AbbVie shall not be obligated to reimburse Infinity for any of the costs associated with such study.

 

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4.2. Medical Affairs Activities .

4.2.1. Responsibilities . The Parties shall collaborate to conduct Medical Affairs Activities in support of Products in the Field throughout the Territory pursuant to the Medical Affairs Plan under the direction of the JMAC.

4.2.2. Medical Affairs Plan . The Medical Affairs Activities in support of Products in the Territory shall be described in a reasonably comprehensive plan (the “ Medical Affairs Plan ”) that describes the Medical Affairs Activities throughout in the Territory, key tactics and strategies for implementing those activities, the relative responsibilities of the Parties and the associated budget for such activities (the “ Medical Affairs Budget ”). The JMAC shall prepare an initial Medical Affairs Plan (with input from the JDC and JCC) for review and approval by the JSC, no later than [**]. On an annual basis thereafter, the JMAC shall meet no later than [**] of each Calendar Year to update the Medical Affairs Plan and shall submit all such updates to the JSC for review and approval, such that JSC preliminary approval would occur no later than [**] of such Calendar Year. Upon the JSC’s preliminary approval, such updates shall be submitted to each Party for its internal budgeting process with a target for final approval by the JSC no later than [**] of such Calendar Year, at which time such Medical Affairs Plan shall be amended accordingly. The JMAC shall also reasonably consider for approval any proposed updates and amendments to the Medical Affairs Plan presented by either Party. The JSC shall review such proposed amendments presented by the JMAC and may approve such proposed amendments or any other proposed amendments that the JSC may consider from time to time and, upon such approval by the JSC, the Medical Affairs Plan shall be amended accordingly.

4.2.3. Investigator Sponsored Clinical Studies . The Medical Affairs Plan and Budget will include the strategy and allocated budget for Investigator Sponsored Clinical Studies that the JMAC determines to conduct. Additional funding for Investigator Sponsored Clinical Studies would require an amendment to the Medical Affairs Budget and require approval by the JMAC. In the event that the JMAC does not approve by consensus (notwithstanding Section 2.9.3) an Investigator Sponsored Clinical Study that has been proposed for inclusion in the Medical Affairs Plan and Medical Affairs Budget by either Party, then the Party proposing such study may conduct such study on its own, and the Party conducting such study shall be responsible for one hundred percent (100%) of the costs of such study, without reimbursement from the other Party under Sections 4.2.7 and 4.2.8, unless the other Party objects in writing to the proposing Party conducting such study within [**] Business Days of the JMAC’s failure to reach consensus which objection may be made by the other Party in its sole discretion. If one Party (the “ Conducting Party ”) does conduct such study at its sole expense, and if the results of such study are used in a Regulatory Approval Application that results in a Label Expansion or compendium expansion for the applicable Product, then the other Party (the “ Reimbursing Party ”) shall reimburse 100% of the Conducting Party’s Out-of-Pocket Costs and Development FTE Costs to conduct such study through quarterly payments, commencing in the Calendar Quarter in which such approval is received, [**] until such amounts are fully paid; provided that if such amounts are not fully repaid within [**] years after the first such payment, then the Reimbursing Party shall pay the Conducting Party all remaining amounts due for such study under this Section 4.2.3 at the conclusion of such [**] year. If Infinity is the Reimbursing Party, then such payments shall be made, with respect to Net Sales in the Ex-US Territory, through a deduction in royalties owed by AbbVie to Infinity with respect to the Ex-US Territory, and, if AbbVie is the Reimbursing Party, then such payments shall be made, with respect to Net Sales in the Ex-US Territory, through an increase in royalties owned by AbbVie to Infinity with respect to Net Sales in the Ex-US Territory. In the United States, Net

 

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Profit and Net Loss for the Reimbursing Party shall be appropriately adjusted to reflect such payment. In the event that[**], then following Regulatory Approval of the AbbVie Combination Compound, nothing in this Agreement would prohibit Infinity from conducting such study on its own outside of the scope of the GDP and this Agreement following Regulatory Approval of the AbbVie Combination Compound, without limiting the provisions governing the Licensed Compound herein (including the exclusivity covenants contained in Section 3.7), as provided in Section 4.1.6, and AbbVie shall not be obligated to reimburse Infinity with respect to such study as provided in this Section 4.2.3; provided , that prior to Commencing such study on its own, [**].

4.2.4. Medical Affairs Reports . At each meeting of the JMAC (or invited JDC or JCC agenda-driven meeting), each Party will report on the Medical Affairs Activities such Party and its Affiliates have performed with respect to Products in the Field since the last meeting of the JMAC, evaluate the work performed in relation to the goals of the Medical Affairs Plan and provide such other information as may be reasonably requested by the JSC with respect to such Medical Affairs Activities.

4.2.5. MSLs . Infinity and AbbVie will each have the right to provide MSLs to support Products in the Territory, on a Product-by-Product basis. Each Party shall have the right to provide up to fifty percent (50%) of the MSL FTEs with respect to each such Product in the Territory, as further specified in the Medical Affairs Plan. The JMAC shall create a MSL Deployment Plan for each of the United States and the Ex-US Territory as determined by the JMAC, and each MSL Deployment Plan will be included in the Medical Affairs Plan. Each MSL Deployment Plan will be consistent with the then-current Medical Affairs Plan. The JMAC shall review and oversee the Parties’ MSL activities in the Territory.

4.2.6. Medical Affairs Standards of Conduct . Each Party shall use Diligent Efforts to execute and to perform, or cause to be performed, the activities assigned to it in the Medical Affairs Plan, and to cooperate with the other Party in carrying out the Medical Affairs Plan, in accordance with the timetables therein. Each Party and its Affiliates shall conduct its Medical Affairs Activities in good scientific manner and in compliance with applicable Law and this Agreement. Notwithstanding anything to the contrary contained herein, a Party or its Affiliates shall not be obligated to undertake or continue any Medical Affairs Activity if such Party (or any of its Affiliates) reasonably determines that performance of such activity would violate applicable Law or other obligation of such Party to a Governmental Authority.

4.2.7. Medical Affairs Costs . Each Party shall be responsible for fifty percent (50%) of all Out-of-Pocket Costs and all Medical Affairs FTE Costs incurred by the Parties to conduct Medical Affairs Activities in accordance with the Medical Affairs Plan and the Medical Affairs Budget (the “ Medical Affairs Costs ”). Medical Affairs Costs shall initially be borne by the Party incurring the cost or expense, and thereafter shall be subject to reimbursement as provided in this Section 4.2.7. Each Party shall report to the JMAC, within [**] days after the end of each Calendar Quarter, an estimate of the Medical Affairs Costs incurred by such Party during such Calendar Quarter, with a final report submitted to the JMAC for such costs within [**] days after the end of each Calendar Quarter. Such report shall specify in reasonable detail all amounts incurred during such Calendar Quarter (broken down by activity).

 

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4.2.8. Reimbursement of Medical Affairs Costs . Following receipt of each Party’s report of its Medical Affairs Costs, the JMAC will determine the payment necessary from one Party to the other, and the Party that has paid less than its share of Medical Affairs Costs during such Calendar Quarter shall make a reconciling payment to the other Party within [**] days after receipt of an invoice from the JMAC to achieve the appropriate allocation of Medical Affairs Costs provided in Medical Affairs Plan and Medical Affairs Budget in accordance with reconciliation procedures to be established by the JMAC (the “ Medical Affairs Reconciliation Procedures ”). The Medical Affairs Reconciliation Procedures will provide the ability to comply with financial reporting requirements of each Party under applicable Laws. Notwithstanding the foregoing, any Medical Affairs Costs in excess of the amounts allocated for the activities of a Party in the applicable Calendar Year in the Medical Affairs Budget shall be borne solely by the Party that incurs such excess costs; provided , however , that Medical Affairs Costs in excess of the budgeted amount shall be included in the calculation of Medical Affairs Costs, (a) to the extent such excess costs do not exceed by more than [**] percent ([**]%) the total Medical Affairs Costs allocated to be incurred by such Party and its Affiliates in the applicable Calendar Year in accordance with the applicable Medical Affairs Budget for such Calendar Year, or (b) if the JMAC approves such excess (either before or after they are incurred), which approval shall not be unreasonably withheld to the extent that such costs in excess of the Medical Affairs Budget were not within the reasonable control of the Party (or Affiliate) incurring such expense. If either Party desires to conduct additional Medical Affairs Activities under the Medical Affairs Budget, it shall discuss the matter at the JMAC. If either Party does not reasonably object to the conduct of such activities but the JMAC is not willing to agree upon an updated Medical Affairs Budget to reflect additional funds to conduct such activities, the requesting Party shall be free to conduct such Medical Affairs Activities and incur additional Medical Affairs Costs in connection therewith; provided , however , that unless such excess costs are required to be reimbursed under Section 4.2.3, such costs shall be the incurring Party’s sole expense.

4.3. Development Efforts; Manner of Performance; Reports .

4.3.1. Development Efforts . Each Party shall use Diligent Efforts to execute and to perform, or cause to be performed, the activities assigned to it in the GDP, and to cooperate with the other Party in carrying out the GDP, in accordance with the timetables therein. Each Party and its Affiliates shall conduct its Development activities in good scientific manner and in compliance with applicable Law and this Agreement. Notwithstanding anything to the contrary contained herein, a Party or its Affiliates shall not be obligated to undertake or continue any Development activities with respect to the Licensed Compounds or Products if such Party (or any of its Affiliates) reasonably determines that performance of such Development activity would violate applicable Law or infringe or misappropriate Third Party intellectual property.

4.3.2. Day-to-Day Responsibility . Each Party shall be responsible for day-to-day implementation of the Development activities for which it (or any of its Affiliates) is assigned responsibility under this Agreement or the GDP and shall keep the other Party reasonably informed as to the progress of such activities. In addition, notwithstanding anything to the contrary in this Agreement:

 

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(a) The Party who is the regulatory sponsor of any Clinical Study of a Licensed Compound or Product or the Party conducting such Clinical Study may terminate or suspend such Clinical Study, without the approval or consent of a Committee or the other Party, if (A) a Regulatory Authority, institutional review board or safety data review board for such Clinical Study has required or recommended such termination or suspension or (B) such Party believes in good faith that such termination or suspension is warranted because of observed safety risks to the study subjects or patients. In either case, the Party making the decision shall promptly notify the other Party of such termination or suspension, and shall use Diligent Efforts to notify and consult with such other Party prior to taking such action; and

(b) If the Party who is not conducting and who is not the regulatory sponsor of any Clinical Study of a Licensed Compound or Product (the “ Non-Sponsor ) believes in good faith that termination or suspension of such Clinical Study is warranted because of safety risks to the study subjects or patients, then the Non-Sponsor shall so notify the other Party (the “ Sponsor ”), and the JDC shall discuss the Non-Sponsor’s concerns in good faith to determine whether to terminate, suspend, modify or continue such Clinical Study. If the JDC and, if applicable following escalation, JSC and Executive Officers are unable to reach agreement with respect to whether to terminate, suspend, modify or continue such Clinical Study, and the Sponsor wants to continue such Clinical Study, the Sponsor shall have the right to do so, provided that the Sponsor shall indemnify and hold harmless the Non-Sponsor from and against any Losses to the extent resulting from any Product Liability Action alleged to be caused by the safety risks raised by the Non-Sponsor and in fact occurring during the conduct of such Clinical Study from and after the date that the Non-Sponsor first notified the Sponsor in accordance with this Section 4.3.2(b) of such safety risks and proposed terminating or suspending such Clinical Study.

4.3.3. Development Reports . At each meeting of the JDC, each Party will report on the Development activities (including Clinical Studies and regulatory activities) such Party and its Affiliates have performed or caused to be performed with respect to Licensed Compounds and Products in the Field since the last meeting of the JDC and the clinical and other results arising from such activities with at least the level of information described in the following sentence, evaluate the work performed in relation to the goals of the GDP and provide such other information as may be reasonably requested by the JDC with respect to such Development activities. If a Party fails to adequately provide such report at a meeting of the JDC, the other Party may request, and such Party will provide to such other Party, a written progress report that includes information regarding subject or patient enrollment, site initiation, progress on protocol writing, meeting requests and briefing documents, in the case of clinical or regulatory activities, and in other cases such information as is reasonably necessary to convey a reasonably comprehensive understanding of the status of the applicable Development activity or, with respect to any such request by Infinity, to comply with its reporting obligations under the Infinity Third Party Agreements.

4.3.4. Notice of Investigation or Inquiry . If any Regulatory Authority (a) contacts a Party or its Affiliate with respect to the alleged improper Development, Manufacture or Commercialization of any Licensed Compound or Product in the Territory, (b) conducts, or gives notice of its intent to conduct, an inspection at a Party’s or its Affiliate’s facilities used in the Development or Manufacturing of Licensed Compound or Products, or (c) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of a Party or its Affiliate that could reasonably be expected to adversely affect any Development, Manufacture or Commercialization activities with respect to a Licensed Compound or Product in the Territory, then such Party shall promptly notify the other Party of such contact, inspection or notice.

 

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4.4. Regulatory Submissions and Regulatory Approvals .

4.4.1. Ownership of Regulatory Approvals . Subject to Sections 4.4.2 and 4.4.3, Infinity or its relevant Affiliates shall file and hold all Regulatory Filings, and shall use Diligent Efforts to seek and attempt to obtain and maintain Marketing Authorizations, for the Products in the Field in the US Territory in accordance with the GDP other than for any Combination Product that includes the AbbVie Combination Compound or the use of the AbbVie Combination Compound with a Licensed Compound or Product. Subject to Section 4.4.3, AbbVie or its relevant Affiliates shall have the sole right to file and hold all Regulatory Filings in the Ex-US Territory, and shall use Diligent Efforts to seek and attempt to obtain and maintain Marketing Authorizations for the Products in the Field in the Ex-US Territory in accordance with the GDP. AbbVie or its relevant Affiliates shall have the right to file and hold all Regulatory Filings in the Field in the Territory for any Combination Product that includes the AbbVie Combination Compound or the use of the AbbVie Combination Compound with a Licensed Compound or Product, and shall, to [**], use Diligent Efforts to seek and attempt to obtain and maintain Marketing Authorizations for such Combination Products in the US Territory and the Ex-US Territory in accordance with the GDP. For clarity, the rights and obligations set forth in this Section 4.4.1shall be in accordance with the GDP. The Parties shall file and hold all Regulatory Filings in eCTD format and in a manner sufficient to permit each Party to comply with its Third Party agreements, including Infinity’s obligations under each of the Infinity Third Party Agreements.

4.4.2. [**] Regulatory Filings . In each of the US, EU and Japan, prior to the first Regulatory Approval in each jurisdiction therein, [**] of a Product conducted under the GDP, the applicable Regulatory Owner will determine [**]. If, in any such regulatory jurisdiction, the Regulatory Owner [**]. In such event, if required by applicable Law for the filing of the Regulatory Approval Application, [**]. Thereafter, the Party [**] with respect to such Regulatory Approval Application under this 4.4.2 shall use Diligent Efforts to seek and attempt to obtain and maintain Marketing Authorizations for the Products in the Field in each such regulatory jurisdiction.

4.4.3. Regulatory Cooperation .

(a) Subject to applicable Law and Section 4.4.2 and this Section 4.4.3, the Party responsible for filing and holding Regulatory Filings and obtaining and maintaining Marketing Authorizations in a particular territory in accordance with Section 4.4.1 (“ Regulatory Owner ”) shall oversee, monitor and manage all regulatory interactions, communications and filings with, and submissions to, Regulatory Authorities with respect to the Products in such territory. The Regulatory Owner shall have final decision making authority regarding all regulatory activities, including the labeling strategy and the content of submissions within such territory, subject to the Global Branding Strategy and the terms and conditions of this Agreement, and the right of the non-owning Party to review and comment on such strategies and submissions. The Regulatory Owner shall ensure that the manner in which a Product shall be presented and described to the medical community in any Promotional Materials and the placement of names and logos of the Parties therein, as permitted by applicable Law, is consistent with the labeling for such Product approved by the applicable Regulatory Authority. To the extent required under applicable Law, the Regulatory Owner shall submit any Promotional Materials for use in the territory for which it is responsible, which have been approved pursuant to this Agreement, to the applicable Regulatory Authorities.

 

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(b) Subject to applicable Law, each Party shall have the right to attend, in an observer role only, all material meetings, conferences and discussions by the other Party or its Affiliate with Regulatory Authorities pertaining to the Development or Regulatory Approval of the Products in the Field. Each Party shall provide the other Party with reasonable advance notice of all such interactions and will provide advance copies of all related documents and other relevant information relating to such interactions. Each Party shall provide the JDC and the JSC with advance drafts of any material documents or other material correspondence pertaining to Regulatory Approvals of the Products, including any proposed labeling, that such Party plans to submit to any Regulatory Authority. The JDC may provide comments regarding such documents and other correspondence prior to their submission, which comments the submitting Party shall consider in good faith. Each Party shall provide the other Party with copies of all material submissions it makes to, and all material correspondence it receives from, a Regulatory Authority pertaining to a Regulatory Approval of a Product. Notices, copies of submissions and correspondence, and other materials to be given in advance as provided in this Section 4.43(b) shall be provided at least [**] Business Days in advance unless circumstances necessitate a shorter time period, and in any event not less than a reasonable time in advance under the circumstances.

(c) Each Party shall make every reasonable effort to notify the other Party promptly upon its determination that any event, incident or circumstance has occurred that may result in the need for a Recall, market withdrawal or stock recovery of a Product (but in no event later than [**] hours and in all cases prior to the execution of such Recall, market withdrawal or stock recovery). For all Recalls, market withdrawals and stock recoveries that are taken, the Regulatory Owner shall be responsible for execution, and the other Party shall reasonably cooperate in all such efforts.

4.4.4. Rights of Reference and Access to Data . Each Party and its Affiliates shall have the right to cross-reference the other Party’s or its Affiliate’s drug master file (“ DMF ”), if any, and any other Regulatory Filings or information supporting Pricing and Reimbursement Approval anywhere in the world, in each case, to the extent such files, filings and support relate to Licensed Compounds or Products in the Field, and to access such Regulatory Filings and any Data and other Know-How therein and use such Data and Know-How in connection with the performance of its obligations and exercise of its rights under this Agreement, including inclusion of such Data and other Know-How in its own Regulatory Filings and filings for Pricing and Reimbursement Approvals for Products in accordance with this Agreement. Each Party hereby grants to the other Party a “ Right of Reference ,” as that term is defined in 21 C.F.R. §314.3(b) in the United States, or an equivalent exclusive right of access/reference in any other country or region of the Territory, to any Data included in a Regulatory Filing or filing for Pricing and Reimbursement Approval for a Product for use by the other Party to Develop and Commercialize the Products in the Field pursuant to this Agreement. Each Party or such Affiliate shall provide a signed statement to this effect, if requested by the other Party, in accordance with 21 C.F.R. §314.50(g)(3) or the equivalent as required in any country or region of the Territory, or otherwise provide appropriate notification of such right of the other Party to the applicable Regulatory Authority.

4.5. Pharmacovigilance . Within [**] days after the Effective Date, the Parties shall establish a process for the exchange of safety data in a mutually agreed format, including but not limited to, postmarketing spontaneous reports and adverse event reports received by the Party or its Affiliates in order to monitor the safety of the Product and to meet reporting requirements with any applicable regulatory authority.

 

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4.6. Costs of Joint Development .

4.6.1. Cost . Development Costs incurred after the Execution Date by a Party in accordance with the GDP and Development Budget shall be borne by Infinity; provided , however , that (a) if the aggregate Development Costs incurred by the Parties, excluding any Combination Study Costs, exceed the Development Threshold, then any Development Costs in excess of the Development Threshold shall be borne fifty percent (50%) by AbbVie and fifty percent (50%) by Infinity (the “ Shared Overage Costs ”), (b) any Development Costs incurred by the Parties in connection with a Combination Clinical Study (the “ Combination Study Costs ,” and together with the Shared Overage Costs, the “ Shared Development Costs ”) shall be borne fifty percent (50%) by AbbVie and fifty percent (50%) by Infinity and (c) [**]. In addition, except as provided in Section 4.1.6(d), Product supply and combination and comparator drug costs incurred by a Party prior to the Execution Date for Clinical Trials included in the initial GDP and contemplated by the initial Development Budget as described in Schedule 4.6.1 will be included as Development Costs hereunder. For the avoidance of double-counting, the Parties acknowledge and agree that Development Costs shall not be included in Allowable Expenses for purposes of calculating Net Profit or Loss in accordance with the Financial Exhibit (and, likewise, that any amounts included in Allowable Expenses shall not be included in Development Costs).

4.6.2. Development Costs Reports . Development Costs shall initially be borne by the Party incurring the cost or expense, and thereafter shall be subject to reimbursement as provided in Section 4.6.3. Each Party shall report to the JDC within [**] days after the end of each Calendar Quarter, the estimated Development Costs incurred by such Party during such Calendar Quarter, with a final report submitted to the JDC within [**] days after the end of each Calendar Quarter. Such report shall specify, in reasonable detail, all amounts included in such Development Costs incurred during such Calendar Quarter (broken down by activity). Within [**] days of receipt of each Party’s report, the JDC shall seek to resolve any questions related to such accounting statements, and shall have the right to request reasonable additional information related to a Party’s and its Affiliates’ Development Costs during such Calendar Quarter in order to confirm that such Party’s spending is in conformance with the approved Development Budget in accordance with the reconciliation procedures to be established by the JDC (the “ Development Reconciliation Procedures ”). The Development Reconciliation Procedures shall provide for the JDC to develop a written summary report setting forth in reasonable detail the calculation of any net amount owed by Infinity to AbbVie or by AbbVie to Infinity, as the case may be, as necessary to accomplish the sharing of Development Costs set forth in Section 4.6.1 and Section 4.6.3, and to prepare such report promptly following the procedures described in this Section 4.6.2 and in a reasonable time in advance of payment.

4.6.3. Reimbursement of Development Costs .

(a) Following completion of the Development Reconciliation Procedures for each Calendar Quarter, the Party conducting a Combination Clinical Study shall invoice the other Party for its share of Combination Study Costs incurred in the preceding Calendar Quarter, and the other Party shall pay each such invoice within [**] days after receipt

 

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thereof; provided , however , that the other Party shall only be obligated to reimburse the conducting Party for Combination Study Costs in excess of the Development Budget (x) to the extent such excess Combination Study Costs do not exceed by more than [**] percent ([**]%) of the total Combination Study Costs in the Development Budget for such Calendar Year; provided , that, for purposes of determining whether such excess Combination Study Costs exceed the total Combination Study Costs in the Development Budget for such Calendar Year by more than [**] percent ([**]%) (i) amounts included in the Development Budget for Combination Study Costs that are not used in a given Calendar Year shall be carried into subsequent Calendar Years, and (ii) if any Combination Clinical Study commences earlier or enrolls faster than anticipated in the GDP, the associated Combination Clinical Study Costs will be added to the Development Budget for the Calendar Year in which such costs are incurred, (y) if the JDC approves such excess Combination Study Costs (either before or after they are incurred), which approval shall not be unreasonably withheld to the extent the Combination Study Costs in excess of the Development Budget were not within the reasonable control of the conducting Party, or (z) pursuant to the provisions of Section 4.1.1. In the event of any dispute regarding the reconciliation payments due from one Party to the other, the Parties shall work together in good faith to resolve such dispute as expeditiously as possible, but the foregoing shall not prevent either Party from pursuing resolution of such dispute through the JDC and, failing agreement at the JDC, escalation to the JSC in accordance with Section 2.9.1. If the JSC is unable to resolve such dispute, then either Party shall have the right to refer such matter for resolution to Arbitration in accordance with ARTICLE 13.

(b) (i) before the Development Threshold has been reached, Infinity shall pay AbbVie an amount of cash sufficient to reimburse AbbVie for any previously agreed-upon (if not explicitly allocated to AbbVie in the GDP) Infinity-Borne Development Costs incurred by AbbVie in each Calendar Quarter and (ii) after the Development Threshold has been reached, the Party (with its Affiliates) that incurs more than its share of the total actual Shared Development Costs shall be paid by the other Party an amount of cash sufficient to reconcile to fifty percent (50%) of actual Shared Development Costs in each Calendar Quarter, in each case within [**] days after receipt of invoice; provided , that the Parties shall also undertake an annual true-up within [**] days after the fourth Calendar Quarter of each Calendar Year. Notwithstanding the foregoing, on a Calendar Year basis, any Shared Development Costs or Infinity-Borne Development Costs in excess of the amounts allocated to such Party for such Calendar Year in the Development Budget shall be borne solely by the Party that incurs such excess Development Costs; provided , however , that Development Costs in excess of the Development Budget shall be included in the calculation of Infinity-Borne Development Costs or Shared Development Costs, as applicable, (x) to the extent such excess Development Costs incurred by a Party do not exceed by more than [**] percent ([**]%) the total Infinity-Borne Development Costs or Shared Development Costs, as applicable, on a Party-by-Party basis, allocated to be incurred by such Party and its Affiliates in the applicable Calendar Year in accordance with the applicable Development Budget for such Calendar Year; provided , however , that, for purposes of determining whether such excess Development Costs exceed the total Infinity-Borne Development Costs or Shared Development Costs, as applicable, for such Calendar Year by more than [**] percent ([**]%), (i) that amounts included in the Development Budget for Infinity-Borne Development Costs or Shared Development Costs, as applicable, that are not used in a given Calendar Year shall be carried into subsequent Calendar Years for purposes of determining whether such threshold has been exceeded, and (ii) if any Clinical Study in the GDP other than a Combination Clinical Study commences earlier or enrolls faster than anticipated in the

 

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GDP, the associated Development Costs will be added to the Development Budget for the Calendar Year in which such costs are incurred, (y) if the JDC approves such excess Development Costs (either before or after they are incurred), which approval shall not be unreasonably withheld to the extent the Development Costs in excess of the Development Budget were not within the reasonable control of the Party (or Affiliate) incurring such expense, or (z) pursuant to the provisions of Section 4.1.1. Notwithstanding the foregoing, all Infinity-Borne Development Costs will be counted toward the Development Threshold.

4.7. Development Records . Each Party shall maintain complete and accurate records (in the form of technical notebooks or electronic files where appropriate) of all work conducted by it under the GDP and all information resulting from such work. Such records, including any electronic files where such information may also be contained, shall fully and properly reflect all work done and results achieved in the performance of the GDP in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. Such records shall be maintained in appropriate conditions to ensure their accessibility and protection until the date that is [**] years after the expiration or termination of this Agreement in its entirety (unless applicable Law requires longer retention of any given record, in which case such record(s) shall be retained for so long as required by applicable Law).

ARTICLE 5.

COMMERCIALIZATION

5.1. Commercialization Efforts .

5.1.1. Oversight . The JCC shall oversee the Commercialization of Products by the Parties in the Field in the Territory.

5.1.2. Responsibilities of the Parties; Costs .

(a) In the US Territory . Each Party shall be responsible for conducting efforts to Commercialize Products in the Field in the US, in accordance with this ARTICLE 5 and the US Commercialization Plan. The Parties shall share costs and expenses incurred in connection with the Commercialization of Licensed Compounds and Products in the US Territory as described in the Financial Exhibit.

(b) In the Ex-US Territory . AbbVie shall be solely responsible for Commercializing Products in the Field in the Ex-US Territory in accordance with this ARTICLE 5 and the Ex-US Commercialization Plans. Except as expressly set forth in this Agreement, AbbVie shall be responsible for all costs and expenses it incurs in connection with the Commercialization of all Licensed Compounds and Products in the Ex-US Territory.

5.1.3. Activities and Participation .

(a) In the US Territory. Each Party shall use Diligent Efforts to execute and to perform, or cause to be performed, the activities assigned to it under the US Commercialization Plan with respect to a Product after obtaining Regulatory Approval for such Product in the US. The JCC may propose amendments to the US Commercialization Plan subject to JSC approval; provided that, in the event of a conflict between the provisions in a US Commercialization Plan authorized hereunder and this Agreement, the provisions of this Agreement shall supersede any US Commercialization Plan.

 

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(b) In the Ex-US Territory . AbbVie shall use Diligent Efforts to Commercialize Products in the Field in the Ex-US Territory after obtaining Regulatory Approval therefor with respect to the applicable country in accordance with the Ex-US Commercialization Plan. The Parties acknowledge and agree that, among other relevant factors, (i) following Generic Entry in a country during the Royalty Term, the level of efforts required by AbbVie to satisfy the foregoing requirement may be different from such level of efforts prior to Generic Entry and (ii) the foregoing requirement does not require AbbVie to Commercialize a Product in any particular country if it would be inconsistent with Diligent Efforts to do so.

(c) No Violation . Notwithstanding anything to the contrary contained herein, a Party and its Affiliates shall not be obligated to undertake or continue any Commercialization activities with respect to the Licensed Compounds or Products if such Party (or such Affiliate) reasonably determines that performance of such Commercialization activity would violate applicable Law or infringe or misappropriate any Third Party intellectual property.

5.2. Manner of Performance .

5.2.1. Day-to-Day Responsibility . Each Party shall be responsible for day-to-day implementation of the Commercialization activities assigned to it under this Agreement and the Commercialization Plans and shall keep the other Party reasonably informed as to the progress of such activities.

5.2.2. Commercialization Reports .

(a) In the US Territory . At each meeting of the JCC, each Party will report on the Commercialization activities (including activities conducted to generate Commercialization Support Data) such Party and its Affiliates and Sublicensees have performed or caused to be performed with respect to Licensed Compounds and Products in the Field in the US since the last meeting of the JCC, evaluate the work performed in relation to the goals of the US Commercialization Plan and provide such other information as may be required by the US Commercialization Plan or reasonably requested by the other Party to permit such other Party to obtain, in reasonable detail, an understanding of the status and performance of such Commercialization activities or to comply with its reporting obligations under the Third Party agreements, including the Infinity Third Party Agreements. The JCC shall review each Party’s and its Affiliates’ and Sublicensees’ performance of Commercialization Activities during each Calendar Quarter and shall provide a report of such progress to the JSC at each quarterly meeting of the JSC.

(b) In the Ex-US Territory . AbbVie shall provide informational updates to the JCC of its planned and completed activities for Commercialization of Products in the Ex-US Territory under the Ex-US Commercialization Plan at each meeting of the JCC and shall respond in a timely fashion to any reasonable requests of Infinity with respect to such activities and results to permit Infinity to obtain, in reasonable detail, an understanding of the status and performance of such Commercialization activities and to comply with its reporting obligations under the Infinity Third Party Agreements.

 

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5.3. Commercialization Plans .

5.3.1. Commercialization Plan Preparation . AbbVie, consistent with its Diligent Efforts obligations, shall determine the countries in the Ex-US Territory that will be included in the Ex-US Commercialization Plan to be submitted to the JCC for review and to the JSC for approval. In addition, AbbVie may prepare country-specific commercialization plans for countries in the Ex-US Territory as it deems appropriate, and shall make such plans available to Infinity. The initial Commercialization Plans for the US and Ex-US Territory shall be prepared by the applicable Party, reviewed by the JCC and approved by the JSC in accordance with this Section 5.3.1 no later than [**]. The Parties shall jointly prepare the initial draft US Commercialization Plan, and shall thereafter alternate responsibility for preparing each draft or annual update to the US Commercialization Plan (starting with Infinity). AbbVie shall prepare the Ex-US Commercialization Plan and each country-specific commercialization plan for the Ex-US Territory, which shall be consistent with the Global Branding Strategy and include an annual forecast of Gross and Net Sales in the Ex-US Territory. Commercialization Plans developed by either Party shall be reviewed by the JCC and presented to the JSC for review and approval; provided , that the country-specific commercialization plans will be shared with the JCC shall not be subject to such JSC approval. The responsible Party shall update each Commercialization Plan annually as provided in Section 5.3.3. The activities set forth in each Commercialization Plan shall at all times be designed to be in compliance with all applicable Laws and to be conducted in accordance with professional and ethical standards customary in the pharmaceutical industry. Each Commercialization Plan shall be prepared in good faith and shall include a mutually agreed upon, rolling [**] Calendar Year plan for Commercializing the Products in the applicable country, countries or region.

5.3.2. US Commercialization Budget . The US Commercialization Budget shall set forth the budgeted amounts for costs with respect to activities allocated to the Parties under such US Commercialization Plan [**] thereafter, and shall include for both Parties a budget for applicable Commercialization FTE Costs and Out-of-Pocket Costs for such period, broken down by Calendar Quarter for the then-current Calendar Year. The US Commercialization Budget shall also include a breakout of costs by functional area or category as determined by the JCC with input and support from the Finance Working Group. Concurrently with the annual update of the US Commercialization Plan in accordance with Section 5.3.1, the JCC will prepare, and the JSC will review and approve an updated US Commercialization Budget for the US Commercialization Plan. The US Commercialization Budget shall be binding unless and until amended in accordance with Section 5.3.1.

5.3.3. Amendments and Updates . Unless otherwise approved by the JSC, the Commercialization activities (and, in the case of the US Territory, the US Commercialization Budget) for the [**] Calendar Year of a Commercialization Plan shall become the Commercialization activities and US Commercialization Budget for the [**] Calendar Year in such subsequent Commercialization Plan unless the Parties otherwise agree; provided , however , that the Commercialization activities and the US Commercialization Budget shall be broken down by Calendar Quarter with respect to the first Calendar Year in each Commercialization Plan. The JCC

 

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shall meet no later than [**] of each Calendar Year to approve updates to each Commercialization Plan and shall submit all such updates to the JSC for review and approval, such that JSC preliminary approval would occur no later than [**] of the Calendar Year preceding such Commercialization Plan. Upon the JSC’s preliminary approval, such updates shall be submitted to each Party for its internal budgeting process with a target for final approval by the JSC no later than [**] of such Calendar Year, at which time such Commercialization Plan shall be amended accordingly. The JCC shall also reasonably consider for approval any proposed updates and amendments to a Commercialization Plan presented by either Party. The JSC shall review such proposed amendments presented the JCC and may approve such proposed amendments or any other proposed amendments that the JSC may consider from time to time in its discretion and, upon such approval by the JSC, the Commercialization Plan shall be amended accordingly. Amendments and updates to a Commercialization Plan, including the US Commercialization Budget, shall not be effective without the approval of the JSC or the Executive Officers or the relevant Party pursuant to Section 2.9. If the JSC does not approve an updated Commercialization Plan, including the US Commercialization Budget, prior to the start of the next Calendar Year, either Party may initiate procedures to resolve the issue pursuant to Section 2.9, and the then-current Commercialization Plan, together with the budgeted amounts set forth in the US Commercialization Budget, shall continue to apply with respect to the relevant Products until the Commercialization Plan is agreed by the JSC or the Executive Officers or the relevant Party pursuant to Section 2.9.

5.4. Global Branding Strategy . Each Party shall implement and adhere to the Global Branding Strategy developed by the JCC and approved by the JSC in its Commercialization of Products in the Territory unless an exception is approved by the JSC or otherwise agreed to by the Parties in writing.

5.5. Commercialization Responsibilities for the US Territory . The Parties shall have responsibility for Commercialization Activities as described below, and the US Commercialization Plan will reflect such allocation of responsibilities unless otherwise mutually agreed by the Parties. The Parties will conduct such activities under the oversight of the JCC, and in each case consistent with the Global Branding Strategy.

5.5.1. Sales Representative Training . The Parties shall jointly conduct training of Sales Representatives with respect to the Product, and shall jointly prepare all related training materials, and each Party shall be solely responsible for training its Sales Representatives on such Party’s compliance policies and such Party’s corporate matters.

5.5.2. Advertising and Public Relations . Infinity shall be responsible for contracting with advertising agencies and Product public relations agencies to support Commercialization of the Product in the US Territory.

5.5.3. Distribution and Patient Services . Infinity shall be responsible for distribution and patient services for the Product in the US Territory, including contracting with applicable service providers.

5.5.4. Advertising and Promotional Materials for Products . The Regulatory Owner shall develop Promotional Materials for review and approval by the JCC relating to the Products for use in the US by both Parties and their Affiliates that are consistent with the Global Branding

 

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Strategy and comply with the US Commercialization Plan, applicable Laws and Marketing Authorizations. Copies of all Promotional Materials used by the Parties and their Affiliates with respect to Products in the US will be archived by AbbVie or Infinity, as applicable, in accordance with applicable Laws. Notwithstanding the foregoing, a Party shall not be obligated to use any Promotional Materials that are not consistent with, and not approved in accordance with, such Party’s internal policies.

5.5.5. Booking Sales in the US Territory . Infinity and its Affiliates shall have the sole right to invoice, to sell and to book all sales of Products in the US Territory, and shall be responsible for warehousing and distributing Products in the US Territory, and the allocation of responsibilities and activities under the US Commercialization Plan shall be made in a manner that permits Infinity to book all sales of Products in the US Territory in accordance with the applicable Accounting Standards. If AbbVie receives any order for a Product in the US Territory, AbbVie shall promptly refer such order to Infinity. If AbbVie receives any order for a Product in the Ex-US Territory from any purchaser and AbbVie knows or has reason to believe that such purchaser intends to sell, offer to sell or distribute such Product in the US Territory, AbbVie shall promptly notify Infinity of such situation and the Parties, through the JSC, will discuss the appropriate resolution. Notwithstanding anything in this Agreement to the contrary, however, with respect to any Product which is a Combination Product comprising both the Licensed Compound and the Abbvie Combination Compound, unless otherwise agreed by the Parties in writing: (i) all Development of such Combination Product would be mutually agreed upon, and conducted pursuant to the GDP and under the direction of the JDC, and final decision making as to any disputes related thereto would be governed by Section 2.9.3(a) and not 2.9.3(g); and (ii) the strategic and tactical components of the Commercialization in the US Territory for such a Combination Product shall be reviewed and determined by the Parties, including, without limitation, the pricing, branding and positioning, promotion, managed care contracting, distribution and patient services, and which Party is the most appropriate Party to book sales of any such Combination Product in the US Territory, it being understood, however, that (x) nothing in this Agreement shall be deemed to have granted to Infinity any right to sell or book sales of the Abbvie Combination Compound or any such Combination Product, and (y) any such Commercialization decisions shall be dependent upon and conform to any and all consents and approvals as are required to be obtained under the Abbvie Third Party Agreements, and (z) Abbvie’s final decision making rights pursuant to Section 2.9.3(g) with respect to all matters relating to the Abbvie Combination Compound shall not govern such determinations, which shall be required to be mutual decisions of the Parties.

5.5.6. Pricing . All decisions with respect to Product list price, targeted net pricing, sales-weighted average discounts and rebates, pricing strategy (including, without limitation, the approach to pricing with different types of accounts and plans, including types of discounts and rebates), and modifications to any of the foregoing, in the US Territory will be made by the JCC.

5.5.7. Other Commercial Functions . The Parties shall share responsibility for all Commercialization activities other than those specifically set forth in Sections 5.5.1 through 5.5.5 for the US Territory under the oversight of the JCC and JSC, in accordance with the applicable Commercialization Plan, including managed care and reimbursement, including negotiating and obtaining pricing or reimbursement approval for the Product and negotiating managed care arrangements in accordance with a strategy formulated by the JCC; monitoring performance of

 

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Sales Representatives; HECOR; commercial advisory boards; and market research, forecasting and competitive intelligence.

5.6. Commercialization in the Ex-US Territory . AbbVie and its Affiliates shall have the sole right to invoice, to sell and to book all sales of Products in the Ex-US Territory, and to establish all terms of sale (including pricing and discounts, provided that AbbVie shall not bundle Products with any other products of AbbVie or its Affiliates without the mutual consent of the Parties), and shall be responsible for warehousing and distributing Products in the Ex-US Territory, and the allocation of responsibilities and activities under the applicable Commercialization Plan shall be made in a manner that permits AbbVie to book all sales of Products in the Ex-US Territory in accordance with the applicable Accounting Standards. If Infinity receives any order for a Product in the Ex-US Territory, Infinity shall promptly refer such order to AbbVie. If Infinity receives any orders for a Product in the US Territory from any purchaser and Infinity knows or has reason to believe that such purchaser intends to sell, offer to sell or distribute such Product in the Ex-US Territory, Infinity shall promptly notify AbbVie of such situation and the Parties, through the JSC, will discuss the appropriate resolution.

5.7. Sales Representatives .

5.7.1. Each sales person used by a Party or its Affiliate to perform in-person presentations of the Products to health care professionals or to perform Sales Calls (each, a “ Sales Representative ”), pursuant to this Agreement shall be employed by such Party or one of its Affiliates on a full-time basis (or engaged by such Party or one of its Affiliates as an independent contractor in his/her individual capacity), or be part of subcontracted sales force engaged in accordance with Section 3.6.

5.7.2. Infinity and AbbVie shall each use Diligent Efforts to cause its and its Affiliates’ Sales Representatives to comply with applicable Laws and industry guidelines related to the performance of its obligations hereunder.

5.7.3. Each Party shall, and shall cause its Affiliates to, maintain records of its Sales Representatives’ activities in accordance with such Party’s standard record keeping procedures. The JCC will define procedures to exchange such data quarterly or more frequently, and to ensure that such data shall be provided at the Product, physician and Sales Representative level, including dates and detail position.

5.8. Co-Promotion in the United States . Infinity and AbbVie will each be obligated to Co-Promote Products in the U.S., on a Product-by-Product basis, by each providing fifty percent (50%) of the Sales Representative FTEs with respect to such Product in the US Territory in accordance with the terms to be determined by the JCC in connection with the preparation and approval of the US Commercialization Plan.

 

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ARTICLE 6.

MANUFACTURE AND SUPPLY

6.1. Manufacture .

6.1.1. Manufacturing Responsibility . Infinity shall be responsible for the Manufacturing of the Licensed Compounds and Products for the Parties’ activities under this Agreement, until such time as the Parties transition such responsibility to AbbVie. No later than [**], the Manufacturing Working Group shall prepare a transition plan which shall describe the activities and timeline to transition manufacturing responsibility to AbbVie, including the establishment of a second source for Licensed Compounds and Products, with the objectives of completing the transfer of responsibility as promptly as possible, while ensuring continuity of supply and adherence to the timelines of the GDP, the Commercialization Plans and in accordance with applicable Law. Until such time as AbbVie assumes responsibility for the Manufacturing of the Licensed Compounds and Products, Infinity shall use Diligent Efforts to supply the Parties’ requirements of Products for Development and Commercialization activities pursuant to this Agreement and the GDP, and, in each case, pursuant to the applicable Supply Agreement. The Party responsible for supplying a Product (whether in drug substance, drug product or finished product form) to the other Party shall supply such Product under the terms of a supply agreement and a related quality agreement (such supply agreements and quality agreements, collectively, the “ Supply Agreements ”), containing terms consistent with this Agreement and typical for such agreements; provided , that in the event of an inconsistency between this Agreement and any such Supply Agreements, such Supply Agreement shall control solely with respect to quality-related and supply-related matters. The Manufacturing Working Group shall determine the timing for entering into the Supply Agreements. Infinity shall deliver to AbbVie a reasonable quantity of initial supply of the Licensed Compound and Product for use in Combination Clinical Studies ([**]), within a reasonable period of time [**], or upon a determination by the Parties to conduct Clinical Studies [**] in accordance with this Agreement. Each Party hereby represents and warrants to the other Party that all Products supplied by such Party hereunder shall be manufactured in accordance with GMP and the applicable global Product specifications. Infinity will not engage any additional Third Party as a secondary source of active pharmaceutical ingredient, drug product and primary and secondary packaging manufacturing supplier for the purposes of establishing a second supply chain without the approval of the Manufacturing Working Group.

6.1.2. Supply Price . The Supply Price of a Product supplied for Clinical Studies under the GDP shall be treated as Development Costs and borne by the Parties in accordance with Section 4.6 with respect to the Calendar Year in which such Products are provided for use in such Clinical Studies. The Supply Price of a Product supplied for Commercialization in (a) the United States shall be taken into account in determining Net Profit or Loss as, and to the extent, provided in the Financial Exhibit and (b) the Ex-US Territory shall be borne by AbbVie and paid to Infinity under the applicable Supply Agreement, to the extent Infinity remains responsible for Manufacturing activities. In all such cases, the Supply Price shall be the Manufacturing cost for such Product, which (a) to the extent such Product is Manufactured by a Party or its Affiliates, shall approximate a reasonable definition of cost of goods sold for such Product with no markup, assuming full utilization of Manufacturing capacity, and (b) to the extent such Product is Manufactured by a Third Party in an arms-length transaction, the Out-of-Pocket Costs paid to such Third Party for the Manufacture of such Product.

6.1.3. Global Quality Agreement . Without limiting Section 6.1.1 with respect to Supply Agreement-specific quality agreements, within [**] days following the Effective Date, the Parties will negotiate in good faith, through the Manufacturing Working Group, and execute a global quality agreement (the “ Quality Agreement ”); provided , that in the event of an inconsistency between this Agreement and such Quality Agreement, such Quality Agreement shall control solely with respect to quality-related matters.

 

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6.1.4. Product Manufacture for Non-Oncology Indications . Infinity may Manufacture the Licensed Compounds and Products for Development in Non-Oncology Indications at all times during the Term. Once AbbVie assumes responsibility for the Manufacturing of the Licensed Compounds and Products, Infinity shall have the right to Manufacture directly or indirectly or purchase Licensed Compounds and Products for Development in Non-Oncology Indications from AbbVie at the Supply Price, subject to activities hereunder having priority over such Development as described in the preceding sentence.

6.2. Manufacturing Working Group . The Manufacturing Working Group shall have responsibility for monitoring and facilitating the overall progress of Manufacturing activities under this Agreement with respect to Products in the Field, including oversight of the various budgets and activities. In particular, the Manufacturing Working Group shall:

6.2.1. develop the transition plan to transfer to AbbVie any Know-How related to the Manufacture of Products and to transition the Manufacture of Products to AbbVie in accordance with Section 6.1.1;

6.2.2. establish standards applicable to the Parties’ performance of Manufacturing activities in accordance with the GDP, each Commercialization Plan and this Agreement, and review each Parties’ performance against such standards;

6.2.3. meet at least quarterly for technical reviews to ensure timely exchange of CMC Development plan technical progress, communication and technical consultations;

6.2.4. share planning and budgeting information with the JDC and JCC and coordinate with the JDC and JCC in preparing comprehensive planning and budgeting proposals with respect to the Manufacturing activities for the Development and Commercialization of Products in the Field; and

6.2.5. perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement as agreed in writing by the Parties.

ARTICLE 7.

FINANCIAL PROVISIONS

7.1. Upfront and Milestone Payments . The provisions of Schedule 7 shall apply.

7.2. Net Profit or Loss .

7.2.1. Net Profit or Loss . Each Party shall bear (and be entitled to) fifty percent (50%) of Net Profit or Loss in the United States. The JCC with input and support from the Finance Working Group shall review quarterly reports of actual results submitted by the Parties and review and discuss potential discrepancies, reasonable forecasting, and other finance and accounting matters, in accordance with the Financial Exhibit and Section 7.2.2 below, as applicable, to determine the reimbursement due, if any, to a Party for each such Calendar Quarter, and shall

 

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establish procedures with respect to the reconciliation of Net Profit or Loss in the United States (the “ Profit Reconciliation Procedures ,” and together with the Development Reconciliation Procedures and the Medical Affairs Reconciliation Procedures, the “ Reconciliation Procedures ”).

7.2.2. Quarterly Reconciliation and Payments . Except to the extent otherwise agreed by the Parties, the Profit Reconciliation Procedures shall provide that:

(a) Within [**] days after the end of each Calendar Quarter, each Party shall submit to the JCC a report with regard to the estimated Net Sales and Allowable Expenses incurred by each Party for the Product during such Calendar Quarter in the US Territory in a manner sufficient to enable the other Party to comply with its financial reporting requirements. A final report of such Net Sales and Allowable Expenses shall be submitted to the JCC within [**] days after the end of each Calendar Quarter. Such report shall specify in reasonable detail all Deductions allowed in the calculation of such Net Sales and all expenses included in Allowable Expenses. Following receipt of such report, each Party shall reasonably cooperate to provide additional information as necessary to permit calculation and reconciliation of Net Profit or Loss in the United States for the applicable Calendar Quarter by the JCC, and to confirm that, to the extent applicable, the Allowable Expenses are in conformance with the US Commercialization Budget. If reasonably requested by the JCC, supporting documentation shall be promptly provided.

(b) The Profit Reconciliation Procedures shall require the JCC with input and support from the Finance Working Group to develop a written report setting forth in reasonable detail the calculation of Net Profit or Loss in the United States for the applicable Calendar Quarter, amounts owed by one Party to the other as necessary to accomplish the sharing of Net Profit or Loss in the United States for the applicable Calendar Quarter in accordance with Section 7.2.1, and to prepare such report promptly following delivery of the reports from the Parties as described above in this Section 7.2.2 and in a reasonable time in advance of applicable payments. Payments to reconcile Net Profit or Loss in the United States shall be paid within [**] days of receipt of such Report by a Party.

(c) Each Party shall (i) keep the other informed as to Gross Sales and Net Sales on a regular, ongoing basis, with respect to Gross Sales and Net Sales levels in the United States, as applicable to such Party, (ii) provide for quarterly reporting of Gross Sales and Net Sales totals in the United States for the applicable Calendar Quarter and (iii) keep the other informed as to forecast Net Profit or Loss in the United States in accordance with the next sentence of this Section 7.2.2(c). Together with such quarterly reporting of Gross Sales and Net Sales, each Party will provide an updated forecast of Net Profit or Loss in the United States for the current Calendar Quarter that such Party may then have available, which forecasts shall be prepared in accordance with such Party’s internal policies and procedures.

7.3. Royalties .

7.3.1. Royalty Rates . As further consideration for the rights granted to AbbVie under this Agreement, on a country-by-country basis, during the applicable Royalty Term, AbbVie shall pay to Infinity non-refundable, non-creditable royalties on Net Sales of Products in the Ex-US

 

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Territory, as calculated by multiplying the applicable royalty rates below by the corresponding amount of incremental Net Sales in the Ex-US Territory of all Products in each Calendar Year:

 

Annual Net Sales of Products in the Ex-US Territory    Royalty Rate

For that portion of aggregate annual Net Sales less than US$[**]

   23.5%

For that portion of aggregate annual Net Sales greater than or equal to US$[**] and less than US$[**]

   [**]%

For that portion of aggregate annual Net Sales greater than or equal to US$[**] and less than US$[**]

   [**]%

For that portion of aggregate annual Net Sales greater than or equal to US$[**]

   30.5%

7.3.2. Royalty Term . Royalties shall be due under this Section 7.3 with respect to a Product and country in the Ex-US Territory during the period commencing on the First Sale of such Product and ending on the date on which AbbVie ceases selling such Product in such country (such period, the “ Royalty Term ”).

7.3.3. Royalty Reduction .

(a) In any country in the Ex-US Territory where all Valid Claims of the Infinity Patent Rights, AbbVie Patent Rights and [**] have ceased to exist that Cover the use, formulation, preparation or manufacture of a particular Product during the Royalty Term for such Product in such country, AbbVie shall owe royalties under this Section 7.3 on Net Sales of such Product in such country at rates that are [**] percent ([**]%) of the rates otherwise payable under Section 7.3.1. If in a particular Calendar Quarter there are Net Sales of a particular Product in one or more countries in the Ex-US Territory in which there is at least one such Valid Claim and there are also Net Sales of such Product in one or more countries in the Ex-US Territory in which there is no such Valid Claim, then the royalties shall be calculated by determining the percentage of Net Sales in the Ex-US Territory in such Calendar Quarter that are in each such type of country and applying that percentage to each royalty tier to determine which portion of the applicable amount should bear royalties at rates set forth in Section 7.3.1 and which should bear royalties at rates set forth in this Section 7.3.3(a).

(b) In the event of Generic Entry in any country in the Ex-US Territory, if the Net Sales in such country of such Product in any Calendar Quarter following the Calendar Quarter in which such Generic Entry occurred are [**], then AbbVie shall owe royalties under this Section 7.3 on Net Sales of such Product in such country during such Calendar Quarter at rates that are [**] percent ([**]%) of the rates otherwise payable under Section 7.3.1. If in a particular Calendar Quarter there are Net Sales of a particular Product in one or more countries in the Ex-US Territory in which there has been a Generic Entry and there are also Net Sales of such Product in one or more countries in the Ex-US Territory in which there has not been a Generic Entry, then the royalties shall be calculated by determining the percentage of Net Sales in the Ex-US Territory in such Calendar Quarter that are in each such type of country and applying that percentage to each royalty tier to determine which portion of the applicable amount should bear royalties at rates set forth in Section 7.3.1 and which should bear royalties at rates set forth in this Section 7.3.3(b). For clarity, the royalty reduction in this Section 7.3.3(b) will no longer apply in any country where a Generic Product is no longer sold in such country.

 

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(c) If, during the Royalty Term, Infinity’s royalty obligations under the MICL Agreement and Purdue Agreement terminate or are reduced, then Infinity shall promptly so notify AbbVie and, with respect to Net Sales occurring after the date of such reduction or termination, each of the royalty rates set forth in Section 7.3.1 shall be reduced on a point-for-point basis by the amount of reduction or termination of the royalty obligations under the MICL Agreement and Purdue Agreement. Within [**] days of the conclusion of each Calendar Year, Infinity shall provide AbbVie with a reasonably detailed report showing all Infinity Third Party Agreement Payments for the preceding Calendar Year.

(d) AbbVie shall be entitled to deduct from the royalties payable to Infinity under this Section 7.3 [**] percent ([**]%) of any Blocking Third Party Intellectual Property Costs paid by AbbVie and [**]; provided , however , that in no event shall the royalties that would otherwise be payable to Infinity, as reduced by Sections 7.3.3(a), 7.3.3(b) and 7.3.3(c) be reduced by more than [**] percent ([**]%) in any given Calendar Quarter as a result of any deduction under this Section 7.3.3(d); and provided further , that AbbVie shall be entitled to carry forward to subsequent Calendar Quarters any amounts with respect to which AbbVie would have been entitled to make a deduction pursuant to this Section 7.3.3(d) but is unable to take such deduction pursuant to the first proviso in this Section.

(e) For clarity, reductions shall first be applied under Section 7.3.3(c), and following any such reductions, further reductions may be applied, as applicable, under Sections 7.3.3(a) or 7.3.3(b) and Section 7.3.3(d), provided , that reductions may be taken under either Section 7.3.3(a) or 7.3.3(b) (or neither), but not both, and, provided further that in no event will the cumulative effect of Section 7.3.3(a), (b) and (d) reduce the royalties that would otherwise be payable to Infinity under Section 7.3.1 by more than [**] percent ([**]%) from the rate in effect following the reduction, if any, under Section 7.3.3(c).

(f) In addition to any other deductions permitted under this Section 7.3.3, the royalties due under this Section 7.3 shall be net of any amounts to be deducted and recouped as provided in Sections 3.5.1(e), 10.6.5(c) and Section 12.2.1(b).

7.3.4. Royalty Payments and Reports . Within [**] days after the end of each Calendar Quarter, AbbVie shall provide to Infinity a statement of the estimated amount of Gross Sales and Net Sales (and the calculations thereof) of Products in each country of the Ex-US Territory during such Calendar Quarter (including such amounts expressed in local currency and as converted to Dollars), identifying the date of First Sale in the relevant country. Within [**] days after the end of each Calendar Quarter, AbbVie shall provide a final statement of such Gross Sales and Net Sales, (and the calculations thereof) of Products in each country of the Ex-US Territory during such Calendar Quarter (including such amounts expressed in local currency and as converted to Dollars) an including a calculation of the amount of royalty payment due on such Net Sales for such Calendar Quarter and any deductions with respect thereto. AbbVie shall pay to Infinity the royalty amounts due under this Section 7.3 with respect to each Calendar Quarter within [**] days after the end of such Calendar Quarter. Without limiting the generality of the foregoing, AbbVie shall require its Affiliates and Sublicensees to account for its Gross Sales and Net Sales and

 

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to provide such reports with respect thereto as if such sales were made by AbbVie. At Infinity’s reasonable request, AbbVie shall use good faith efforts to provide Infinity with additional information necessary for Infinity to comply with its royalty reporting obligations under any Infinity Third Party Agreements.

7.4. Reconciliation of Costs Incurred in or for the Ex-US Territory .

7.4.1. Costs Borne Solely by AbbVie . On a Calendar Quarterly basis, Infinity shall determine all amounts payable by AbbVie to Infinity to reimburse the applicable portion of costs incurred by Infinity in such Calendar Quarter under Sections 3.5.1(d) and 3.5.2 (Infinity Third Party Agreement Payments) in connection with the Development, Manufacture or Commercialization of Products in the Ex-US Territory in accordance with the GDP or the Ex-US Commercialization Plans and the terms of this Agreement (such amounts, the “ Reimbursable Amounts ”). Infinity shall provide a reasonably detailed invoice to AbbVie for such amounts after the end of each Calendar Quarter in which such amounts were incurred. AbbVie shall pay each such invoice within [**] days after its receipt thereof.

7.4.2. Costs and Recoveries [**] all Out-of Pocket Costs incurred under Section 8.7.2(c)(iii) (Product Trademark Costs) relating to the registration and maintenance of Product Trademarks in the Ex-US Territory (the “[**]”), under Section 8.7.5 relating to Product Trademark enforcement in the Ex-US Territory, and under Section 8.7.3 for Actions in the Ex-US Territory. Recoveries under Sections 8.3.7 and 8.7.5 for the Ex-US Territory [**]. Within [**] days after the end of each Calendar Quarter, [**] shall submit to the JCC an estimated report, in such reasonable detail and format as is established by the JCC with input and support from the Finance Working Group, of all [**] incurred or accrued during such Calendar Quarter, with a final report submitted to the JCC within [**] days after the end of each Calendar Quarter. Following receipt of such report, the Finance Working Group shall determine [**]. The reconciliation for the fourth Calendar Quarter in any Calendar Year shall include [**]. Within [**] days after the Finance Working Group’s determination, the applicable Party shall pay the other Party the amount due.

7.5. Financial Audits .

7.5.1. Each Party and its Affiliates shall keep complete and accurate records in accordance with its Accounting Standards of the items underlying the Milestone Payments, Development Costs, Allowable Expenses, Gross Sales, Net Sales, Net Profit or Loss, Reimbursable Amounts, [**], Infinity Third Party Agreement Payments, and the other elements thereof required to prepare the reports or calculate payments required under this Agreement and the Reconciliation Procedures, and any other payments under this Agreement. Each Party will have the right annually at its own expense to have an independent, certified public accountant, selected by such Party and reasonably acceptable to the other Party, review any such records of the other Party and its Affiliates in the location(s) where such records are maintained by the other Party or its Affiliates upon reasonable prior written notice, during regular business hours and under obligations of confidentiality, for the sole purpose of verifying the basis and accuracy of payments made under this Agreement and the Reconciliation Procedures, and any other payments due under this Agreement, within the prior [**] Calendar Year period. The records for any Calendar Year may be audited no more than once.

 

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7.5.2. Upon the expiration of [**] years following the end of any Calendar Year, the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon Infinity and AbbVie, and the Parties shall be released from any liability or accountability with respect to payments for such Calendar Year.

7.5.3. The report prepared by the independent certified public accounting firm, a copy of which shall be sent or otherwise provided to each Party by such independent public accountant at the same time, shall contain the conclusions of such accounting firm regarding the audit and will specify that the amounts paid pursuant thereto were correct or, if incorrect, the amount of any underpayment or overpayment, and the specific details regarding any discrepancies. No other information shall be provided to the auditing Party without the prior consent of the audited Party unless disclosure is required by law, regulation or judicial order, and if so determined by the auditing Party, it shall, if permitted, give the audited Party prior notice thereof reasonably sufficient for the audited Party to seek a protective order against or limiting such disclosure. If such report shows any underpayment, the Party owing a payment (“ Owing Party ”) shall remit to the Party that is owed (“ Owed Party ”), within [**] days after receipt of such report, (a) the amount of such underpayment, together with interest calculated in the manner provided in Section 7.9, and (b) if such underpayment exceeds [**] percent ([**]%) of the total amount owed for the period then being audited, the reasonable Out-of-Pocket Costs incurred in conducting such review. Any overpayments shall be refunded to the Owed Party by the Owing Party within [**] days of receipt of the audit report. The Parties mutually agree that all information subject to review under this Section is Confidential Information of the audited Party (subject to Sections 1.122(a)-(d)) and that the Party receiving such information shall retain and cause the accountant to retain all such information in confidence in accordance with ARTICLE 9.

7.6. Tax Matters .

7.6.1. Each Party shall be solely responsible for the payment of all taxes imposed on its share of income arising directly or indirectly from the collaborative efforts of the Parties under this Agreement, except as expressly set forth in this Section 7.6.

7.6.2. A Party shall withhold and deduct from all payments made (or to be made) pursuant to this Agreement by such Party (the “ Withholding Party ”), any tax required to be withheld and deducted from such payments under applicable Law and in accordance with this Section 7.6. Any amounts so withheld and deducted shall be remitted by the Withholding Party on a timely basis to the appropriate Governmental Authority for the account of the other Party and the Withholding Party will provide the other Party reasonable evidence of the remittance within [**] days thereof. To the extent that amounts are so withheld by the Withholding Party and duly paid over to the appropriate Governmental Authority, such withheld amounts shall be treated for all purposes of this Agreement as having been paid to the other Party, in respect of which such deduction and withholding was made. Each Party shall furnish to the Withholding Party such forms, certificates and documentation as may be necessary or appropriate, and that are legally required, to obtain any reduction of, credit for, or exemption from the withholding of any tax.

7.6.3. If AbbVie (or AbbVie’s Affiliates or successors) is required to make a milestone payment attributable to an Enrollment Event or a Milestone Event that occurred in an Ex-US Territory, or that is treated by the appropriate Governmental Authority as occurring in an Ex-US Territory, or a royalty payment that is based on Net Sales of Products in an Ex-US Territory, and Withholding Tax is deducted from such payment when made to Infinity as a result of an AbbVie Withholding Tax Action, then notwithstanding Section 7.6.2:

 

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(a) if such Withholding Tax is the result of a Required Withholding Tax Action, then AbbVie (or AbbVie’s Affiliates, or successors) shall make a payment to Infinity equal to fifty percent (50%) of the excess of the Required Incremental Withholding Tax over the Required Withholding Tax Benefit, if any, for the taxable year to which the Required Incremental Withholding Tax relates; and

(b) if such Withholding Tax is the result of an AbbVie Withholding Tax Action that is not a Required Withholding Tax Action, then AbbVie (or AbbVie’s Affiliates or successors) shall make a payment to Infinity equal to one-hundred percent (100%) of the excess of the Incremental Withholding Tax over the Withholding Tax Benefit, if any, for the taxable year to which the Incremental Withholding Tax relates.

Infinity shall compute the payments due under clause (a) and (b) for each year during the Term no later than [**] days after filing its U.S. federal income tax return for such taxable year. Any such payment referenced in clause (a) or (b) shall be made to Infinity within [**] days of the date on which Infinity provides (i) written notice that a payment is due and (ii) its computation of the amount of the payment. Any Withholding Tax as a result of payments for Incremental Withholding Tax and Required Incremental Withholding Tax under this Section 7.6.3, along with any other Withholding Tax, shall be timely remitted to the proper Governmental Authority for the account of Infinity in accordance with applicable Law and AbbVie shall provide Infinity reasonable evidence of the remittance within [**] days of such remittance. The Parties will cooperate with respect to all documentation required by any taxing authority or reasonably requested by either Party to secure a reduction in the rate of applicable withholding taxes and similar obligations on payments made under this Agreement.

7.6.4. If for any taxable year of Infinity, an Infinity Affiliate or successor, the Required Withholding Tax Benefit exceeds the Required Incremental Withholding Tax for such taxable year, or the Withholding Tax Benefit exceeds the Incremental Withholding Tax for such taxable year, then Infinity shall make a payment or payments to AbbVie as follows:

(a) Infinity (or Infinity’s Affiliates or successors) shall make a payment to AbbVie equal to fifty percent (50%) of the excess of the Required Withholding Tax Benefit over the Required Incremental Withholding Tax, if any, for such taxable year or; and

(b) Infinity (or Infinity’s Affiliates or successors) shall make a payment to AbbVie equal to one hundred percent (100%) of the excess of the Withholding Tax Benefit over the Incremental Withholding Tax, if any, for such taxable year.

Infinity hereby agrees to inform AbbVie in the event that a payment is owed under this Section 7.6.4 within [**] days of the date on which Infinity, the Infinity Affiliate or successor files its United States Federal tax return for such taxable year. Infinity further agrees to make the requisite payments to AbbVie within [**] days of the filing of such return. Upon request, Infinity shall provide AbbVie with a reconciliation of the computation of the amount of the payments under this Section to the disclosures in the tax footnote to its audited financial statements.

 

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7.6.5. Section 7.6.3 shall apply only if the recipient of the payment thereunder, whether Infinity, an Infinity Affiliate or successor, is a tax resident of the United States and the beneficial owner of the payment.

7.6.6. In the event that a taxing authority retroactively determines that a payment made by a Withholding Party to the other Party pursuant to this Agreement should have been subject to withholding or to additional withholding of taxes, and the Withholding Party remits such taxes to the taxing authority, the Withholding Party will have the right (a) to offset such amount, including any interest and penalties that may be imposed thereon (except to the extent any such interest or penalties result from the gross negligence of the Withholding Party), against future payment obligations of the Withholding Party under this Agreement, (b) to invoice the other Party for such amount (which shall be payable by the other Party within [**] days of its receipt of such invoice) or (c) to pursue reimbursement by any other available remedy.

7.6.7. All amounts payable under this Agreement are exclusive of value added tax or any similar consumption tax or duties (“ Indirect Taxes ”). If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by the receiving Party in respect of those payments. The Parties shall issue invoices for all amounts payable under this Agreement consistent with requirements for Indirect Taxes and irrespective of whether the sums may be netted for settlement purposes. If the Indirect Taxes originally paid or otherwise borne by the paying Party are in whole or in part subsequently determined not to have been chargeable, all necessary steps will be taken by the receiving Party to receive a refund of these undue Indirect Taxes from the applicable governmental authority or other fiscal authority and any amount of undue Indirect Taxes repaid by such authority to the receiving Party will be transferred to the paying Party within [**] days of receipt.

7.7. Currency Exchange .

7.7.1. Currency of Payments . All payments under this Agreement shall be paid in U.S. Dollars, by wire transfer to an account designated by the receiving Party (which account the receiving Party may update from time to time in writing).

7.7.2. Currency Conversion . Except with respect to the calculation of Net Sales, for which the currency conversion shall be determined in accordance with the definition of “Net Sales,” if any amounts that are relevant to the determination of amounts to be paid under this Agreement or any calculations to be performed under this Agreement are denoted in a currency other than U.S. Dollars, then such amounts shall be converted to their U.S. Dollar equivalent as follows:

(a) With respect to amounts denoted in U.S. Dollars, all such amounts shall be expressed in U.S. Dollars; and

 

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(b) With respect to amounts denoted in a currency other than U.S. Dollars, all such amounts shall be expressed both in the currency in which the amount was denoted and in the U.S. Dollar equivalent. The U.S. Dollar equivalent shall be calculated using the relevant Party’s then-current standard procedures and methodology, including its then-current standard exchange rate methodology for the translation of foreign currency expenses into U.S. Dollars or, in the case of Sublicensees, such similar methodology, consistently applied.

For clarity, the currency conversion provisions, and other relevant definitions and provisions, of the relevant Infinity Third Party Agreement shall apply to calculate the relevant Infinity Third Party Agreement Payments.

7.8. Blocked Payments . If, by reason of applicable Laws in any country, it becomes impossible or illegal for a Party or its Affiliate or Sublicensee to transfer, or have transferred on its behalf, payments to the other Party, the owing Party shall promptly notify the owed Party of the conditions preventing such transfer and such distribution fees or other payments shall be deposited in local currency in the relevant country to the credit of the owed Party in a recognized banking institution designated by the owed Party or, if none is designated by the owed Party within a period of [**] days, in a recognized banking institution selected by the owing Party or its Affiliate and identified in a written notice given to the owed Party.

7.9. Late Payments . Interest shall be payable by a Party on any amounts payable to the other Party under this Agreement which are not paid by the due date for payment. All interest shall accrue and be calculated on a daily basis (both before and after any judgment) at a rate per annum equal to [**] above the then-current “prime rate” in effect published in The Wall Street Journal, Eastern Edition (but in no event in excess of the maximum rate permissible under applicable Law), for the period from the due date for payment until the date of actual payment. The payment of such interest shall not limit the Party owed the relevant payment from exercising any other rights it may have as a consequence of the lateness of any payment. For clarity, the Party owing such interest shall be solely responsible for paying such interest to the other Party and such interest shall not be considered Development Costs or Net Profit or Loss or in any other manner shared by the Parties.

ARTICLE 8.

INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS

8.1. Ownership of Inventions .

8.1.1. Sole Inventions . As between the Parties, each Party (or its Affiliate) shall exclusively own all inventions conceived solely by the employees or agents of such Party or its Affiliates in the course of such Party’s and its Affiliates’ performance of Development, Manufacturing or Commercialization activities under this Agreement (“ Sole Inventions ”). Sole Inventions conceived solely by the employees and agents of AbbVie or its Affiliates are “ AbbVie Sole Inventions ”. Sole Inventions conceived solely by the employees and agents of Infinity or its Affiliates are “ Infinity Sole Inventions ”.

 

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8.1.2. Joint Inventions . The Parties or their Affiliates shall jointly own all inventions conceived jointly by employees and agents of AbbVie or its Affiliates, on the one hand, and employees and agents of Infinity or its Affiliates, on the other hand, in the course of performing Development, Manufacturing or Commercialization activities under this Agreement (“ Joint Inventions ”), on the basis of each Party (or its Affiliate, as applicable) having an undivided interest in the whole without a duty to account to the other Party. To the extent not inconsistent with any terminal disclaimer, each Party and its Affiliates shall have the right to sell or otherwise transfer its interest in such Joint Invention, and related Joint Patent Rights, to its Affiliates or Third Parties, in each case without the consent of the other Party, so long as such sale or transfer is subject to the licenses granted pursuant to this Agreement and is otherwise consistent with this Agreement.

8.1.3. [**]. As between the Parties, and notwithstanding any other provision of this Agreement, [**] shall own all Know-How and Patent Rights first conceived or first reduced to practice solely by the employees or agents of either Party or its Affiliates or jointly by employees and agents of AbbVie or its Affiliates, on the one hand, and employees and agents of Infinity or its Affiliates, on the other hand in the course of [**] and, [**] shall, and hereby does, assign its interest in or to any [**] will provide all further cooperation that [**] reasonably requests to give effect to [**], including executing and delivery further assignments, consents, releases and other commercially reasonable documentations and providing (and causing its Affiliates, and its and its Affiliates’ employees and agents to provide) good faith testimony by affidavit, declaration, deposition, in person or other proper means and otherwise assisting [**] in support of any effort to establish, perfect, defend or enforce its rights in the [**] shall at all times retain rights in [**]. Notwithstanding the foregoing, this Section 8.1.3 shall not apply in respect of any Know-How and Patent Rights that are first conceived or first reduced to practice as a result of activities undertaken prior to the Effective Date.

8.1.4. Inventorship . For purposes of determining whether an invention is an AbbVie Sole Invention, an Infinity Sole Invention or a Joint Invention, questions of inventorship shall be resolved in accordance with United States patent Laws, whether or not such invention is patentable or patented.

8.1.5. Third Party Agreements .

(a) Infinity Third Party Agreements . The provisions of Sections 8.2 through 8.6 are subject to the terms of each applicable Infinity Third Party Agreement and shall be interpreted in a manner that is consistent with the rights of the relevant Third Party counterparty (and its licensors) under the relevant Infinity Third Party Agreement.

(b) AbbVie Third Party Agreements . The provisions of Sections 8.2 through 8.6 are subject to the terms of each applicable AbbVie Third Party Agreement and shall be interpreted in a manner that is consistent with the rights of the relevant Third Party counterparty (and its licensors) under the relevant AbbVie Third Party Agreement. [**].

8.1.6. Joint Patent Rights . For purposes of determining the rights and obligations of the Parties under Sections 8.2 through 8.4, each Party’s interest in Joint Patent Rights shall be considered only Joint Patent Rights, and not Infinity Patent Rights or AbbVie Patent Rights.

8.1.7. Assignment Obligation . Each Party shall cause all employees of such Party who perform activities for such Party under this Agreement to be under an obligation to assign their

 

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rights in any inventions, whether or not patentable, resulting therefrom to such Party. With respect to any activities subcontracted to a Person that is not an employee, the Party retaining such subcontractor shall use commercially reasonable efforts to include in the applicable subcontract an assignment to such Party of all rights in inventions made by such subcontractor resulting from such activities. If a Party is not able to include such assignment, then such Party shall notify the IP Working Group, and the IP Working Group will determine whether such Party may subcontract such activities on different invention ownership terms. If the IP Working Group is unable to agree on such matter, the matter will be referred to the JDC for resolution.

8.1.8. IP Working Group . The Parties’ shall coordinate their activities under Sections 8.2 through 8.6 through the IP Working Group.

8.2. Prosecution and Maintenance of Patent Rights .

8.2.1. [**] Prosecution .

(a) [**] shall have the sole right, subject to Section 8.2.1(b), using in-house or outside legal counsel selected by [**] and mutually acceptable to each Party, to prepare, file, prosecute and maintain the [**] on a global basis. As of the Effective Date, [**] are mutually acceptable to the Parties. [**] shall, with respect to [**], keep [**]reasonably informed of all steps with regard to and the status of the preparation, filing, prosecution, and maintenance of such patent rights, including by providing [**] with (i) copies of all correspondence and material communications it sends to or receives from the US Patent and Trademark Office (the “ USPTO ”), the European Patent Office (“ EPO ”) and equivalent patent offices in foreign jurisdictions, relating to the [**] Rights, (ii) a draft copy of all applications sufficiently in advance of filing to permit reasonable review and comment by [**], and (iii) a copy of applications as filed, together with notice of its filing date and serial number. Before [**] submits any material filing, including a new patent application, or response to such patent authorities with respect to the [**] with drafts of such filing or response and provide [**] with a reasonable opportunity to review and comment on such filing or response. [**] shall take into account and consider in good faith [**] reasonable and timely requests and suggestions regarding the filing, prosecution and maintenance of the [**] under this Section 8.2.1(a).

(b) If [**] elects not to continue to prosecute a patent application within the [**], or elects not to maintain a patent within the [**] shall give [**] notice thereof within a reasonable period (but not less than [**] days) prior to allowing such patent applications or patents to lapse or become abandoned or unenforceable. The IP Working Group shall discuss the Parties’ respective views, and [**]; provided , however , that this Section 8.2.1(b) shall not apply if, instead of prosecuting such patent application, [**] instead files a divisional, continuation or continuation-in-part of such patent application, which divisional, continuation or continuation-in-part covers the same or greater scope for the relevant Product(s) as the [**] proposed to be abandoned.

(c) If a Third Party initiates a patent opposition, reexamination, or other pre- or post-grant proceeding in the USPTO, EPO or foreign equivalent, asserting that any [**] is invalid or otherwise unenforceable, other than in response to an infringement Action bought pursuant to Section 8.3, [**] shall control the response to such proceeding, but shall consult

 

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with [**] and shall take into account and consider in good faith [**] reasonable and timely requests and suggestions. For clarity, the provisions of Section 8.2.1(a) and 8.2.1(b) shall apply to any of these proceedings controlled by [**] shall not settle any such proceeding without [**] consent, such consent not to be unreasonably withheld. To the extent any amounts are paid in settlement of such proceeding with respect to [**], the same shall be shared equally by the Parties.

8.2.2. [**] Patent Rights Prosecution .

(a) [**] shall have the first right, using in-house or outside legal counsel selected by [**] and mutually acceptable to each Party, to prepare, file, prosecute and maintain the [**] shall, with respect to [**], keep [**] reasonably informed of all steps with regard to and the status of the preparation, filing, prosecution, and maintenance of such patent rights, including by providing [**] with (i) copies of all correspondence and material communications it sends to or it receives from the USPTO, the EPO and equivalent patent offices in foreign jurisdictions, relating to the [**], (ii) a draft copy of all applications sufficiently in advance of filing to permit reasonable review and comment by [**], and (iii) a copy of applications as filed, together with notice of its filing date and serial number. Before [**] submits any material filing, including a new patent application, or response to such patent authorities with respect to the [**] shall provide [**] with drafts of such filing or response and provide [**] with a reasonable opportunity to review and comment on such filing or response. [**] shall take into account and consider in good faith [**] reasonable and timely requests and suggestions regarding the filing, prosecution and maintenance of the [**] under this Section 8.2.2(a).

(b) If [**] elects not to continue to prosecute a patent application within the [**], or elects not to maintain a patent within the [**] shall give [**] notice thereof within a reasonable period (but not less than [**] days) prior to allowing such patent applications or patents to lapse or become abandoned or unenforceable. The IP Working Group shall discuss the Parties’ respective views, and [**]; provided , however , that this Section 8.2.2(b) shall not apply if, instead of prosecuting such patent application, [**] instead files a divisional, continuation or continuation-in-part of such patent application, which divisional, continuation or continuation-in-part covers the same or greater scope for the relevant Product(s) as the [**] proposed to be abandoned.

(c) If a Third Party initiates a patent opposition, reexamination, or other pre- or post-grant proceeding in the USPTO, EPO or foreign equivalent, asserting that any [**] is invalid or otherwise unenforceable, other than in response to an infringement Action bought pursuant to Section 8.3, [**] shall control the response to such proceeding, but shall consult with [**] and shall take into account and consider in good faith [**] reasonable and timely requests and suggestions. For clarity, the provisions of Section 8.2.2(a) and (b) shall apply to any of these proceedings controlled by [**] shall not settle any such proceeding without [**] consent, such consent not to be unreasonably withheld. To the extent any amounts are paid in settlement of such proceeding with respect to an [**] by the Parties.

8.2.3. [**] Patent Rights . The Parties, through the IP Working Group, [**] decide whether, and how, to file, prosecute and maintain the [**] (other than the [**]) and shall [**] with respect thereto.

 

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8.2.4. Maintenance and Prosecution Costs . All reasonable Patent Costs incurred by the Parties and their respective Affiliates with respect to [**], and the [**] shall be considered “[**]” and shall be included in [**].

8.2.5. Cooperation . Each Party shall, and shall cause its Affiliates to, reasonably cooperate, with the other with respect to the preparation, filing, prosecution and maintenance of Infinity Patent Rights, Joint Product Patent Rights and AbbVie Patent Rights pursuant to this Section 8.2.

8.3. Third Party Infringement .

8.3.1. Patent Enforcement Strategy . Promptly following the [**] of [**], the Parties, through the IP Working Group, shall meet and discuss generally the Parties’ enforcement strategy in both the US Territory and the Ex-US Territory with respect to the Infinity Patent Rights, AbbVie Patent Rights or Joint Patent Rights, which such strategy shall guide the Parties in their decision making with respect to enforcement of such Patent Rights pursuant to this Section 8.3.1, and [**]. In addition, upon receipt of notice by a Party under 8.3.2 of an actual or potential infringement by a Third Party of any Infinity Patent Rights, AbbVie Patent Rights or Joint Patent Rights, the IP Working Group will again convene with respect to the particular strategy to be undertaken with respect thereto, in light of the general strategy previously agreed upon.

8.3.2. Notice . Each Party shall promptly notify the other of any apparent, threatened or actual infringement by a Third Party of any Infinity Patent Rights, AbbVie Patent Rights or Joint Patent Rights of which it becomes aware, including receipt of any notice filed pursuant to 21 U.S.C.§355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or any notice under comparable US or foreign Law (a “ Paragraph IV Certification ”), with respect to the Infinity Patent Rights, AbbVie Patent Rights or Joint Patent Rights.

8.3.3. Enforcement of [**].

(a) [**] shall have the first right to institute any infringement Action under any [**] where a Party reasonably determines that a Third Party is marketing or plans to market an infringing product [**] that competes with a Product, including such an infringement resulting from a Paragraph IV Certification. [**] shall have the right to institute such Action in the name of [**], or in the names of both of them.

(b) If [**] institutes an infringement Action in accordance with Section 8.3.3(a), [**] shall have the right to review and comment upon material strategic decisions relating to such Action, provided that [**] shall have the final say with respect thereto. In addition, [**] shall, and shall cause its Affiliates to, reasonably cooperate with [**] in its efforts to protect such [**] and shall agree to join as a party in any such Action, if required to give [**]. Further, [**] shall have a right, in [**] sole discretion, to join or otherwise participate in such Action with legal counsel selected by [**] shall notify and keep [**] apprised in writing of such Action and shall consider and take into account [**] reasonable interests and requests regarding such Action.

(c) If [**] does not institute an infringement Action to protect the [**] (i) [**] may institute such infringement Action. In such event, [**] shall have the right, but not the obligation, to institute such Action in the name of [**] or of [**], or in the names of both of them.

 

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If [**] institutes an infringement Action in accordance with this Section 8.3.3(c), [**] shall, and shall cause its Affiliates to, reasonably cooperate with [**] in its efforts to protect such [**] and shall agree to join as a party in such Action, if required to give [**]. Further, [**] shall have a right, in [**] sole discretion, to join or otherwise participate in such Action with legal counsel selected by [**] shall notify and keep [**] apprised in writing of such Action and shall consider and take into account [**] reasonable interests and requests regarding such Action.

8.3.4. Enforcement of [**].

(a) [**] shall have the first right to institute any infringement Action under only those [**] for the Product [**], where a Party reasonably determines that a Third Party is marketing or plans to market an infringing product [**] that competes with a Product, including such an infringement resulting from a Paragraph IV Certification. [**] shall have the right to institute such Action in the name of [**], or in the names of both of them.

(b) If [**] institutes an infringement Action in accordance with Section 8.3.4(a), [**] shall have the right to review and comment upon material strategic decisions relating to such Action, provided that [**] shall have the final say with respect thereto. In addition, [**] shall, and shall cause its Affiliates to, reasonably cooperate with [**] in its efforts to protect such [**] and shall agree to join as a party in any such Action, if required to give [**]. Further, [**] shall have a right, in [**] sole discretion, to join or otherwise participate in such Action with legal counsel selected by [**] shall notify and keep [**] apprised in writing of such Action and shall consider and take into account [**] reasonable interests and requests regarding such Action.

(c) If [**] does not institute an infringement Action to protect such [**] from such infringement in a [**] (i) [**] may institute such infringement Action. In such event, [**] shall have the right, but not the obligation, to institute such Action in the name of [**] or of [**], or in the names of both of them. If [**] institutes an infringement Action in accordance with this Section 8.3.4(c), [**] shall, and shall cause its Affiliates to, reasonably cooperate with [**] in its efforts to protect such [**] and shall agree to join as a party in such Action, if required to give [**]. Further, [**] shall have a right, in [**] sole discretion, to join or otherwise participate in such Action with legal counsel selected by [**] shall notify and keep [**] apprised in writing of such Action and shall consider and take into account [**] reasonable interests and requests regarding such Action.

8.3.5. Enforcement of [**].

(a) [**] shall have the first right to institute infringement Action under the [**] where a Party reasonably determines that a Third Party is marketing or plans to market an infringing product in any country in the Territory that competes with a Product, including such an infringement resulting from a Paragraph IV Certification. [**] shall have the right to institute such Action in the name of [**] or of [**], or in the names of both of them.

(b) If [**] institutes an infringement Action in accordance with Section 8.3.5(a), [**] shall have the right to review and comment upon material strategic decisions relating to such Action, provided that [**] shall have the final say with respect thereto. [**] shall, and shall cause its Affiliates to, reasonably cooperate with [**] in its efforts to protect such [**] and shall

 

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agree to join as a party in such Action, if required to give [**]. Further, [**] shall have a right, in [**] sole discretion, to join or otherwise participate in such Action with legal counsel selected by [**] shall notify and keep [**] apprised in writing of such Action and shall consider and take into account [**] reasonable interests and requests regarding such Action.

(c) If [**] does not institute an infringement Action to protect the [**] from such infringement [**] (i) [**] or (ii) [**] may institute such infringement Action. In such event, [**] shall have the right, but not the obligation, to institute such Action in the name of [**] or of [**], or in the names of both of them. If [**] institutes an infringement Action in accordance with this Section 8.3.5(c), [**] shall, and shall cause its Affiliates to, reasonably cooperate with [**] in its efforts to protect such [**] and shall agree to join as a party in such Action, if required to give [**]. Further, [**] shall have a right, in [**] sole discretion, to join or otherwise participate in such Action with legal counsel selected by [**] shall notify and keep [**] apprised in writing of such Action and shall consider and take into account [**] reasonable interests and requests regarding such Action.

8.3.6. Cooperation . In any infringement Action brought under the [**] pursuant to Sections 8.3.3, 8.3.4 or 8.3.5, each Party shall, and shall cause its Affiliates to, reasonably cooperate with each other, in good faith, relative to the other Party’s efforts to protect the [**] in accordance with Sections 8.3.3, 8.3.4 or 8.3.5 and shall agree to be a party to such suit, if necessary. Notwithstanding the above, [**] or [**] brought pursuant to Sections 8.3.3, 8.3.4 or 8.3.5 without the prior written consent of the other Party, which consent shall not be unreasonably withheld. Furthermore, the Party initiating any infringement Action pursuant to Sections 8.3.3, 8.3.4 or 8.3.5 shall provide the other Party with reasonable prior notice and opportunity to review and comment on, and shall consider in good faith all reasonable and timely comments from such other Party on, any proposed arguments asserted or to be asserted in litigation related to the enforcement or defense of any such Patent Rights pursuant to Sections 8.3.3, 8.3.4 or 8.3.5.

8.3.7. Expenses and Recoveries . All reasonable Out-of-Pocket Costs incurred by either Party pursuant to Sections 8.3.3, 8.3.4 or 8.3.5 in connection with enforcement of Patent Rights shall be [**]. Any recovery obtained as a result of any such Action, by settlement or otherwise, shall be [**].

8.3.8. Other Enforcement .

(a) The Parties shall jointly decide whether and how to enforce the Joint Patent Rights [**]. If required under applicable Law in order for the initiating Party to initiate or maintain a suit pursuant to this Section 8.3.8(a), the other Party or its Affiliate shall join as a party to the suit and shall offer reasonable assistance to the initiating Party in connection therewith. Unless otherwise agreed by the Parties, [**].

(b) [**].

(c) [**].

8.3.9. Claimed Infringement .

 

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(a) Each of the Parties shall promptly notify the other if a Third Party brings any Action alleging patent infringement by AbbVie or Infinity or any of their respective Affiliates or Sublicensees with respect to the Development, Manufacture or Commercialization of any Licensed Compound or Product (any such Action, an “ Infringement Claim ”). In the case of any Infringement Claim, the Parties shall promptly, and within [**] days after written notice from either Party to the other thereof, discuss which Party shall control the response to such Infringement Claim, and if the Parties do [**], the [**], subject to ARTICLE 11, [**]. Upon the request of the Party controlling the response to the Infringement Claim, the other Party shall reasonably cooperate with the controlling Party in the reasonable defense of such Infringement Claim. The other Party will have the right to consult with the controlling Party concerning any Infringement Claim and to participate in and be represented by independent counsel in any associated litigation. If the Infringement Claim is brought against both Parties, then each Party shall have the right to defend against the Infringement Claim.

(b) Subject to ARTICLE 11, with respect to any Infringement Claim for allegedly infringing activities conducted in or for the US, each Party shall bear [**] obtained by the Third Party asserting such Infringement Claim, by settlement or otherwise; provided , that, the Party with respect to which such Infringement Claim was brought had performed the allegedly infringing Development, Manufacture or Commercialization of a Licensed Compound or Product in accordance with this Agreement; in all other cases, the Party [**]. Subject to ARTICLE 11, the Out-of-Pocket Costs in defending, and providing requested assistance in the defense of, such Infringement Claim for allegedly infringing activities conducted in or for the [**] shall be considered [**], unless the Party with respect to which the Infringement Claim was brought [**] Development, Manufacture or Commercialization of a [**], in which case [**].

8.4. Patent Term Extensions . [**] shall have the sole right to determine which [**], if any, to extend pursuant to the U.S. Drug Price Competition and Patent Term Restoration Act of 1984, the Supplementary Certificate of Protection of Member States of the EU and other similar measures in any country in the Territory, in order to protect any Product. [**] shall cooperate with [**] requests in connection therewith and use reasonable efforts to help gain any such patent term extension pursued at the direction of [**]. All Out-of-Pocket Costs incurred by either Party pursuant to this Section 8.4 shall be considered Shared Patent Prosecution Costs and included in the Development Costs.

8.5. Patent Marking . Each Party shall mark each Product made, used or sold under this Agreement (or when the character of the product precludes marking, the package containing any such Product) in accordance with all applicable Laws relating to patent marking.

8.6. Orange Book Listings . [**] shall have the sole right to determine which [**] to list in the Orange Book in the U.S. or other foreign equivalents and shall, at its discretion, undertake, at its costs and expense, to file any relevant information in order to ensure appropriate listing in the Orange Book relating to the Product; provided that [**] shall consult with [**] and the IP Working Group in making such determination, and [**] will cooperate with [**] reasonable requests in connection therewith.

 

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8.7. Trademarks .

8.7.1. Retained Rights in Corporate Marks and Logos . Each Party and its Affiliates shall retain all right, title and interest in and to its and their respective corporate names and logos. Neither Party shall use the other Parties’ corporate names or logos without obtaining prior written consent of the other Party.

8.7.2. Product Trademark .

(a) Selection . The JCC shall select a global Product Trademark for Products throughout the world consistent with the Global Branding Strategy.

(b) Promotion . Each Product shall be promoted and sold, in accordance with the provisions of this Agreement, in the Territory under the applicable Product Trademarks unless such Product Trademark cannot be legally used (either for regulatory or trademark law reasons), or the Parties agree that it is not commercially viable to use such Product Trademark, to promote and sell the Product in a country, in which case an alternative Product Trademark proposed by the JCC, with respect to a Product, shall be used in such country.

(c) Ownership .

(i) Infinity (or its Affiliates, as appropriate) shall own and retain all rights to Product Trademarks for Products worldwide, and all goodwill associated with or attached thereto arising out of the use thereof by the Parties, their Affiliates and Sublicensees shall inure to the benefit of Infinity. AbbVie, on behalf of itself and its Affiliates, hereby assigns to Infinity or its relevant Affiliate all right, title and interest in and to such Product Trademarks and goodwill. AbbVie will not contest, oppose or challenge Infinity’s ownership of such Product Trademarks.

(ii) Infinity shall own rights to any Internet domain names incorporating any Product Trademark, or any variation or part of any Product Trademark, as its URL address or any part of such address.

(iii) Infinity will use Diligent Efforts to register, maintain and enforce the Product Trademarks during the Term. All costs of such registration, maintenance and enforcement efforts (the “ Product Trademark Costs ”) shall be (A) Allowable Expenses to the extent such costs relate to Product Trademarks in the US and (B) shared equally by the Parties in accordance with Section 7.4.2 to the extent such costs relate to Product Trademarks in the Ex-US Territory.

8.7.3. Co-Branding . Unless otherwise agreed to by the Parties, all Promotional Materials relating to a Product in the Field shall display the applicable Product Trademark(s) and no other product-specific trademarks or branding; provided , however , that (a) to the extent permitted by Law and if reasonably practicable, the Parties shall include the Intellikine name or logo (the “ Intellikine Mark ”) on commercial packaging for such Product in the U.S. and a disclosure that the Intellikine Mark is licensed from Intellikine; provided , however , that any use of the Intellikine Mark shall be in compliance with Intellikine’s then-current reasonable trademark guidelines provided to Infinity and AbbVie; and (b) each Party shall, to the extent permitted by Law and unless otherwise agreed to by the JCC, include the corporate names of both Parties on packaging, labels, containers, advertisements and other materials related thereto with respect to the Products.

 

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Intellikine or an Affiliate of Intellikine shall retain the ownership of the entire right, title and interest in and to the Intellikine Mark, and all goodwill associated with or attached to the Intellikine Mark arising out of the use thereof by the Parties, their Affiliates and Sublicensees shall inure to the benefit of Intellikine. Neither Party will contest, oppose or challenge Intellikine’s ownership of the Intellikine Mark. Each Party agrees that it will not at any time do any act or thing that will in any way impair Intellikine’s ownership of or rights in and to the Intellikine Mark or any registration thereof or that may depreciate the value of the Intellikine Mark or the reputation of Intellikine.

8.7.4. Quality Control . AbbVie agrees that the quality of the Products, and the Manufacture and Commercialization thereof, to the extent undertaken by AbbVie, marketed under the Product Trademarks shall be consistent with the specifications set forth in the relevant Supply Agreement and the standards of quality customary in the pharmaceuticals industry. Each Party shall, and shall cause its respective Affiliates to, comply with then-current trademark style and usage standards approved by Infinity, in accordance with this Agreement, in connection with the use of the Product Trademarks or approved by the applicable Party in connection with the use of its name or logo; provided , however , that the applicable Party shall approve any such standards with respect to the trademark style or use of its corporate names or logos. AbbVie shall, and shall cause its Affiliates to, at its own expense, submit a sample of each proposed use of a Product Trademark to the JCC for approval, which approval shall not be unreasonably withheld or delayed. Each Party shall, and shall cause its Affiliates to, at its own expense, submit a sample of each proposed use of the other Party’s name or logo to the JCC for approval, which approval shall not be unreasonably withheld or delayed. If the Party owning, as applicable, the relevant Product Trademark, name or logo reasonably objects to a proposed usage of a Product Trademark, name or logo, it shall give written notice of such objection to the other Party within [**] days of receipt by the JCC of such sample, specifying the way in which such usage of its Product Trademark, name or logo fails to meet the quality, style or usage standards for such Product or Product Trademark, name or logo set forth in the first two sentences of this Section 8.7.4. If the non-owning Party or its Affiliate wishes to use such sample, it must remedy the failure and submit further samples to the JCC for approval.

8.7.5. Enforcement . If either Party becomes aware of any infringement of any Product Trademark by a Third Party, such Party shall promptly notify the other Party. With respect to any such enforcement in the US Territory, the Parties shall promptly meet to determine how to enforce the Product Trademark in the US and the strategy for such enforcement, provided that [**] shall have the first right to bring and control such enforcement action in the [**] shall have the first right to bring and control such enforcement action for infringements of the Product Trademarks in the [**], but consistent with the agreed strategy for the [**] if there is a similar [**] case, and [**] shall keep [**] reasonably informed of such efforts. Upon [**] request, [**] shall reasonably cooperate with [**] in such enforcement efforts, including by joining or instituting any trademark litigation as a party where doing so is required for standing purposes under applicable Law. If [**] does not bring such Action in the [**] Territory within [**] days after the Parties’ discussion under the first sentence of this Section 8.7.5, then [**] shall have the right to do so, consistent with the agreed strategy for the [**] if there is a similar [**] case, and [**] shall keep [**] reasonably informed of such efforts. Upon [**] request, [**] shall reasonably cooperate with [**]in such enforcement efforts, including by joining or instituting any trademark litigation as a party where doing so is required for standing purposes under applicable Law. The costs incurred by the Parties pursuant to this Section 8.7.5 shall be (a) considered [**] to the extent such costs relate to enforcing the Product Trademarks in the US and (b) [**] by the Parties in accordance with Section 7.4.2, to

 

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the extent such costs relate to enforcing the Product Trademarks in the Ex-US Territory, and the [**] by the Parties pursuant to this Section 8.7.5 shall be (x) considered Other Income in calculating Net Profit or Loss, to the extent such recoveries arise from enforcing the Product Trademarks in the US and (y) [**] by the Parties in accordance with Section 7.4.2, to the extent such recoveries arise from enforcing the Product Trademarks in the Ex-US Territory.

ARTICLE 9.

CONFIDENTIALITY AND PUBLICITY

9.1. Confidential Information .

9.1.1. During the Term and for a period of [**] years after any termination or expiration of this Agreement, or such longer period as may be required under any Existing Infinity Third Party Agreement or Existing AbbVie Third Party Agreement, each Party agrees to, and shall cause its Affiliates to, keep in confidence and not to disclose to any Third Party, or use for any purpose, except to exercise its rights or perform its obligations under this Agreement, any Confidential Information of the other Party.

9.1.2. Each Party agrees that it and its Affiliates shall provide or permit access to the other Party’s Confidential Information only to the receiving Party’s employees, consultants, advisors and Sublicensees, and to the employees, consultants and advisors of the receiving Party’s Affiliates, in each case who are subject to obligations of confidentiality and non-use with respect to such Confidential Information no less stringent than the obligations of confidentiality and non-use of the receiving Party pursuant to this Section 9.1; provided , that each Party shall remain responsible for any failure by its Affiliates and Sublicensees, and its and its Affiliates’ respective employees, consultants and advisors, to treat such Confidential Information as required under Section 9.1 (as if such Affiliates, employees, consultants, advisors and Sublicensees were parties directly bound to the requirements of this Section 9.1).

9.1.3. Notwithstanding anything to the contrary herein, each Party may use and disclose the other Party’s Confidential Information as follows: (a) under appropriate written confidentiality obligations substantially equivalent to those in this Agreement, to its Affiliates, potential and actual permitted Sublicensees, contractors and any other Third Parties, to the extent such use or disclosure is reasonably necessary to perform its obligations or to exercise its rights under this Agreement, including but not limited to Section 4.1.6 herein; (b) to the extent such disclosure is consistent with this Agreement and is reasonably necessary for filing or prosecuting patent applications claiming the Development, Manufacture or Commercialization of Licensed Compounds or Products; (c) to its advisors (including financial advisors, attorneys and accountants), actual or potential acquisition partners, financing sources or investors and underwriters on a need to know basis, in each case under appropriate confidentiality obligations (which may include professional ethical obligations) substantially equivalent to those in this Agreement; or (d) to the extent such disclosure is reasonably necessary: (i) in complying with the terms of the Existing Infinity Third Party Agreements and AbbVie Third Party Agreements that exist as of the Execution Date; (ii) in complying with the terms of agreements with Third Parties related to Licensed Compounds or Products that are entered into after the Execution Date; provided , that such agreements are entered into in compliance with the terms of this Agreement; or (iii) in prosecuting or defending litigation, complying with applicable Law as reasonably

 

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determined by such Party’s counsel, conducting Clinical Studies with respect to a Product in accordance with this Agreement, in Regulatory Filings, filings for Pricing and Reimbursement Approval or other communications or submissions to Regulatory Authorities with respect to a Product in accordance with this Agreement, or submitting information required to be submitted to Tax or other Governmental Authorities.

9.2. Residual Knowledge Exception . Notwithstanding any provision of this Agreement to the contrary, neither Party shall be liable for the internal use by its employees of Residual Knowledge for the purpose of conducting research, development and/or commercialization of pharmaceutical products for such Party or its Affiliates; provided , that (a) no use or reference to written or electronic copies of the disclosing Party’s Confidential Information or notes from review or exposure to such disclosing Party’s Confidential Information shall have been made to remember or complement such Residual Knowledge and (b) any such use made by a receiving Party of Residual Knowledge is on an “as is, where is” basis, with all faults and all representations and warranties disclaimed and at its sole risk.

9.3. Publicity .

9.3.1. Initial Press Releases . Promptly following the Execution Date, the Parties shall issue a mutually agreed press release regarding the subject matter of this Agreement, including a description of the financial terms, scope of planned Development and value of the Agreement, in the form attached hereto as Exhibit E .

9.3.2. Further Publicity . The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding the Products in the Field that may include information that is not otherwise permitted to be disclosed under this ARTICLE 9, and that may be beyond what is required by Law, and each Party may make such disclosures from time to time. Such disclosures may include achievement of milestones, significant events in the Development process with respect to the Products, Commercialization activities with respect to the Products and the like. Except for the initial press releases described in Section 9.3.1:

(a) Whenever either Party elects to make any such public disclosure, it shall first notify the other Party of such planned press release or public announcement and provide a draft for review no less than [**] Business Days in advance of issuing such press release or making such public announcement (or, with respect to press releases and public announcements that are required by applicable Law, with as much advance notice as possible under the circumstances if it is not possible to provide notice no less than [**] Business Days in advance). Each Party shall have the right to review and approve any such planned press release or public announcement proposed by the other Party, including any oral presentation or abstract, that contains Clinical Data or pertains to results of Clinical Studies or other studies with respect to the Licensed Compounds or Products, or that includes Confidential Information of the other Party; provided , however , that (A) the reviewing Party shall attempt to provide such approval as soon as reasonably possible and shall not unreasonably withhold such approval; (B) the reviewing Party shall provide explanations of its disapproval of such press release; and (C) a Party desiring to make such public disclosure may issue such press release or public announcement without such prior review by the other Party if (i) the contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by such Party, and (ii)

 

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such press release or public announcement does not materially differ from the previously issued press release or other publicly available information; and provided , further , that the other Party shall have the right to review, but not approve, any press release or public announcement that the proposing Party determines is required by applicable law based on the advice of counsel, which public disclosures are subject to Section 9.3.2(b). The Party reviewing a press release provided under this Section 9.3.2 will review and approve or disapprove such press release within [**] Business Days after its receipt thereof. A press release will be deemed approved if the reviewing Party does not provide its disapproval during the reviewing period. If the reviewing Party disapproves of the press release within the reviewing period, either Party may refer the matter to the JSC for resolution together with the reasons for the withholding of approval. The JSC will make a decision on such matter within [**] Business Days after such referral. If the JSC cannot reach consensus on the matter within such [**] Business Day period, such publication or public disclosure shall be deemed not approved, notwithstanding anything in Section 2.9.3 to the contrary. For clarity, in the event a publication contemplated by this Section 9.3.2 implicates a Third Party’s rights under a AbbVie Third Party Agreement or Infinity Third Party Agreement, the counter party under such agreement shall be considered a reviewing Party and shall have the right to review and approve any planned press release or public announced proposed by the other Party, subject to the terms and conditions set forth herein.

(b) The principles to be observed in such disclosures shall include accuracy, compliance with applicable Law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of the FDA (and its foreign counterparts) and the need to keep investors informed regarding the business of the Party making such public disclosure. Nothing in this Section 9.3 shall restrict a Party from making a disclosure required by Law as reasonably determined by such Party’s counsel, including disclosures required by any laws or regulations relating to the public sale of securities.

9.4. Publications .

9.4.1. Global Publication Strategy . The JMAC shall develop a global publication strategy (with input from the JDC and JCC) for the publication or presentation of scientific information related to the Licensed Compounds and Products in the Field for approval by the JSC (the “ Global Publication Strategy ”). The JMAC may from time to time develop and submit to the JSC for approval proposed substantive amendments to the Global Publication Strategy. The JSC shall review such proposed amendments presented and may approve such proposed amendments or any other proposed amendments that the JSC may consider from time to time in its discretion and, the Global Publication Strategy shall be amended accordingly. The Parties acknowledge that each of Infinity and AbbVie has entered into agreements with Third Parties prior to the Execution Date, and may enter into agreements with Third Parties on or after the Execution Date, which permit such Third Parties to make publications regarding Licensed Compounds or Products, and agree that the Global Publication Strategy shall accommodate the ability of such Third Parties to make such publications; provided , that any publications contemplated by a Third Party under an Agreement with such Third Party that was entered into on or after the Execution Date shall be subject to review and comment by the other Party. Notwithstanding the foregoing (or Section 9.4.2), the Global Publication Strategy shall not be construed to limit a Party’s rights to make disclosures pursuant to Section 9.3.

 

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9.4.2. Approval of Publications .

(a) Except as set forth in Sections 9.3 or 9.4.2(b), the publication and presentation of the results of Development carried out on the Licensed Compounds and Products in the Field (whether such Development is carried out by a Party, its Affiliates, Sublicensees or subcontractors) shall be governed by the Global Publication Strategy, and the Parties agree to conduct their publication activities in accordance with the Global Publication Strategy.

(b) Prior to the adoption of the Global Publication Strategy, the following procedures shall apply with respect to the Parties’ or their Affiliates’ publication and presentation of the results of Development carried out on the Licensed Compounds and Products in the Field: Prior to publishing or presenting the results of any Development activities related to the Licensed Compounds or Products, each Party (the “ Publishing Party ”) shall provide to the other Party (the “ Reviewing Party ”) a copy of any proposed abstracts, manuscripts or summaries of presentations that such Publishing Party intends to publish or present (“ Proposed Publications ”). Each Party shall designate in writing an individual(s) who shall be responsible for reviewing (or having reviewed) all Proposed Publications submitted by the other Party and may change such individual(s) on written notice to the other Party. Within [**] Business Days after receipt by the Reviewing Party, a designated individual of the Reviewing Party shall notify the Publishing Party in writing whether the Reviewing Party has an objection to the Proposed Publication because such Proposed Publication contains Confidential Information or patentable Know-How of the Reviewing Party or the Reviewing Party believes in good faith that such Proposed Publication is not in the best interests of the Exploitation of the Product. If a Reviewing Party notifies a Publishing Party that it has such an objection, the Publishing Party shall reasonably cooperate with the Reviewing Party to address such concern. The Publishing Party shall reasonably consider any other suggestions of the Reviewing Party. With respect to any proposed abstracts, manuscripts or summaries of presentations that investigators or other Third Parties propose to publish or present, such materials shall be subject to review under this Section 9.42(b) to the extent that Infinity or AbbVie, as the case may be, has the right to do so.

9.5. Public Filing of this Agreement . The Parties acknowledge that either or both Parties may be obligated to file a copy of this Agreement or any Related Agreement with the Securities & Exchange Commission or other Government Authorities and each Party is hereby authorized to comply with such obligation; provided , that each Party shall have the right to review and comment upon such filing, such comments to be considered in good faith and to be included in any such filing unless the filing Party has a good faith belief that the inclusion of such comments or any proposed redactions would violate its disclosure obligations under applicable securities law, or would adversely effect its ability to ultimately obtain confidential treatment for such filing.

ARTICLE 10.

REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS

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

 

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10.1.1. Organization . It is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement.

10.1.2. Authority . It has full right, power and authority to enter into this Agreement and to perform its respective obligations under this Agreement, it has the right to grant to the other the licenses and sublicenses granted pursuant to this Agreement, and this Agreement and the performance by such Party of this Agreement do not violate such Party’s charter documents, bylaws or other organizational documents.

10.1.3. Consents . Except for any Marketing Authorizations, Regulatory Filings, manufacturing approvals or similar approvals necessary for the Development, Manufacture or Commercialization of the Licensed Compounds and Products, all necessary consents, approvals and authorizations of all Governmental Authorities and other Persons required to be obtained by it in connection with the execution, delivery and performance of this Agreement have been obtained.

10.1.4. No Conflict . It is not under any obligation, contractual or otherwise, to any Person that would adversely affect the diligent and complete fulfillment of obligations hereunder and the execution and delivery of this Agreement by such Party, and the performance of such Party’s obligations hereunder (as contemplated as of the Execution Date) and the licenses and sublicenses to be granted by such Party pursuant to this Agreement (a) do not conflict with or violate any requirement of Laws applicable to such Party, (b) do not conflict with or violate any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to such Party, and (c) do not conflict with, violate, breach or constitute a default under any contractual obligations of such Party or any of its Affiliates.

10.1.5. Enforceability . This Agreement is a legal and valid obligation binding upon it and is enforceable against it in accordance with its terms, subject to the general principles of equity and subject to bankruptcy, insolvency, moratorium, judicial principles affecting the availability of specific performance and other similar Laws affecting the enforcement of creditors’ rights generally.

10.2. Additional Representations and Warranties of Infinity . Infinity represents and warrants to AbbVie that, as of the Execution Date:

10.2.1. Existing Patents . All Infinity Patent Rights existing as of the Execution Date are listed on Exhibit B (the “ Existing Patents ”). Infinity is, with respect to each Existing Patent listed on Exhibit B-1 the sole and exclusive owner of the entire right, title and interest in such Existing Patent; and with respect to each Existing Patent listed on Exhibit B-2, the sole and exclusive licensee of such Existing Patents. All Existing Patents are (i) subsisting and in good standing and (ii) being diligently prosecuted in the respective patent offices in the Territory in accordance with Law, and have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment. To Infinity’s knowledge, all issued Existing Patents are subsisting and are not invalid or unenforceable, in whole or in part.

 

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10.2.2. Existing Know-How . All Know-How being used by Infinity to Exploit the Licensed Compound and Products as of the Execution Date (a) constitues Infinity Know-How and is being licensed to AbbVie hereunder or (b) is generally known to the public.

10.2.3. Delivery of Documentation . True, complete, and correct copies of: (a) all Existing Regulatory Filings relating to the Product; and (b) all material adverse information with respect to the safety and efficacy of the Licensed Compound known to Infinity, in each case ((a) and (b)) have been provided or made available to AbbVie prior to the Execution Date.

10.2.4. Third Party Challenges to Infinity IP . There are no claims, judgments, or settlements against, or amounts with respect thereto, owed by Infinity or any of its Affiliates relating to the Existing Patents or the Infinity Know-How. No claim or litigation has been brought or, to Infinity’s knowledge, threatened by any Person (a) alleging that the Existing Patents are invalid or unenforceable, (b) asserting the misuse, or non-infringement of any of the Infinity Patent Rights, (c) challenging Infinity’s Control of the Infinity Patent Rights or (d) alleging misappropriation of the Infinity Know-How.

10.2.5. Ownership and Encumbrances . Except as set forth in the Existing Infinity Third Party Agreements, the Infinity Patent Rights are free and clear of any liens, charges, encumbrances or, to Infinity’s knowledge, claims of ownership by any Third Party, other than (a) non-exclusive licenses granted by Infinity to Third Parties, which grants are not in conflict with, and do not preclude AbbVie from exercising, the licenses granted to AbbVie hereunder, or of the nature of material transfer agreements, clinical trial agreements and manufacturing agreements, which will not adversely affect AbbVie’s ability to Develop, Manufacture and Commercialize the Products in accordance with this Agreement, and (b) the rights of the relevant Third Party counterparties to the Existing Infinity Third Party Agreements and their licensors. Infinity is entitled to grant the licenses specified in the Agreement.

10.2.6. Non-Infringement of Third Party IP . To Infinity’s knowledge, the Development, Manufacture and Commercialization of the Licensed Compounds or Products, as conducted by Infinity prior to the Execution Date did not infringe any then-issued Patent Right or misappropriate any then-existing Know-How or other intellectual property or proprietary right of any Person. To Infinity’s knowledge, the Development, Manufacture and Commercialization of the Licensed Compounds or Products as specifically described in the initial GDP attached hereto as Exhibit C (other than the Combination Clinical Studies) would not infringe any Patent Right issued as of the Effective Date or misappropriate any Know-How or other intellectual property or proprietary right of any Person existing as of the Effective Date. To Infinity’s knowledge, the Infinity Patent Rights and Infinity Know-How comprise all of the Patent Rights and Know-How necessary for Developing the Licensed Compound and Product, other than Patent Rights and Know-How necessary for Developing any other active ingredient in Combination Products, in accordance with the Development Plan and for Commercializing the Product as it exists on the Execution Date. No written claim of infringement of the Patent Rights or misappropriation of the Know-How of any Third Party has been made, or to Infinity’s knowledge, threatened, against Infinity or any of its Affiliates with respect to the Development, Manufacture or Commercialization of the Licensed Compound or Products.

 

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10.2.7. Absence of Litigation . Except as identified in Schedule 10.2.7, there are no judgments or settlements against or owed by Infinity or, to Infinity’s knowledge, pending litigation against Infinity or litigation threatened against Infinity in writing, in each case related to the Product, including any relating to any Regulatory Filings Controlled by Infinity as of the Effective Date.

10.2.8. US Government Rights . Neither Infinity nor any of its Affiliates is or has been a party to any agreement with the U.S. federal government or an agency thereof pursuant to which the U.S. federal government or such agency provided funding for the Development of a Licensed Compound or Product, and the inventions claimed or covered by the Existing Patents are not a “subject invention” as that term is described in 35 U.S.C. Section 201(f).

10.2.9. Existing Infinity Third Party Agreements . (a) The Existing Infinity Third Party Agreements existing as of the Execution Date are the only agreements between Infinity and any Third Party pursuant to which Infinity has in-licensed any Existing Patents or pursuant to which Infinity owes any Third Party any royalties with respect to Licensed Compounds or Products; (b) prior to the Execution Date, Infinity has provided AbbVie with an opportunity to review complete and correct copies of the Existing Infinity Third Party Agreements existing as of the Execution Date; (c) to Infinity’s knowledge, such Existing Infinity Third Party Agreements remain in full force and effect as of the Execution Date; (d) as of the Execution Date, Infinity is in material compliance with the terms of such Existing Infinity Third Party Agreements and, to Infinity’s knowledge, the counterparties to such Existing Infinity Third Party Agreements are in material compliance with the terms of such Existing Infinity Third Party Agreements; and (e) Infinity has obtained any and all consents required under such Third Party Agreements as may be necessary to perform its obligations under this Agreement. Without limiting Section 10.1.4, the terms of this Agreement do not breach or constitute a default under the terms of any Existing Infinity Third Party Agreement.

10.2.10. Maintenance of Regulatory Filings, Good Laboratory and Clinical Practices . Infinity and its Affiliates have generated, prepared, maintained, and retained all Regulatory Filings that are required to be maintained or retained pursuant to and in material compliance with applicable Law, and have conducted in material compliance with applicable Law, including GLP and GCP, (a) all Development of the Licensed Compound or the Products in the Field that they have conducted prior to the Execution Date and (b) all Research activities that are material to the receipt of Regulatory Approval for the Product.

10.2.11. Confidentiality of Know-How . To the knowledge of Infinity and its Affiliates, no material breach of confidentiality has been committed by any Third Party with respect to the Infinity Know-How and Infinity has used reasonable measures to protect the confidentiality thereof.

10.2.12. Assignment of Third Party Rights .

(a) Infinity has obtained from each of its Affiliates, employees and agents, and from the employees and agents of its Affiliates, who are participating in the Exploitation of the Licensed Compound or Products, rights to any and all Know-How created by such employees and agents that relates to the Licensed Compound or Products, such that AbbVie

 

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shall, by virtue of this Agreement, receive from Infinity, without payments beyond those required by ARTICLE 7, the licenses and other rights granted to AbbVie hereunder, except with respect to those Persons from whom obtaining such rights is not customary, such as academic and non-profit Persons.

(b) Each Person who has or has had any ownership rights in or to any Existing Patents purported to be owned solely by Infinity, has assigned and has executed an agreement assigning its entire right, title, and interest in and to such Existing Patents to Infinity; to Infinity’s knowledge, no current officer, employee, agent, or consultant of Infinity or any of its Affiliates is in violation of any term of any assignment or other agreement, in each case, regarding the protection of Patents or other intellectual property or proprietary information of Infinity or such Affiliate.

(c) Infinity and its Affiliates have employed (and, with respect to such tests and studies that Infinity will employ) Persons with appropriate education, knowledge and experience to conduct and to oversee the conduct of the pre-clinical and clinical studies with respect to the Licensed Compound and Products.

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

10.3. Additional Representations and Warranties of AbbVie . AbbVie represents and warrants to Infinity that as of the Execution Date:

10.3.1. to its knowledge, AbbVie and its Affiliates do not own or Control any Patent Rights that Cover or claim any Licensed Compound, Product, or Exclusivity Compound, or the use of any of the foregoing.

10.3.2. neither AbbVie nor any of its Affiliates have received notice that AbbVie or its Affiliates do not have, or will not have, the right to conduct the Combination Clinical Studies.

10.3.3. AbbVie is not subject to any non-compete or other restrictions that would impair its ability to Develop and Commercialize the Licensed Compound or Product in the Field in the Territory as contemplated on the Execution Date.

10.4. No Debarment . Each Party represents and warrants that neither it nor any of its or its Affiliates’ employees or agents performing hereunder has ever been, or is currently: (A) debarred under 21 U.S.C. § 335a; (B) excluded, debarred, suspended, or otherwise ineligible to participate in Federal health care programs or in Federal procurement or non-procurement

 

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programs; (C) listed on the FDA’s Disqualified and Restricted Lists for clinical investigators; or (D) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible. Each Party further covenants that if, during the term of this Agreement, it becomes aware that it or any of its or its Affiliates’ employees or agents performing hereunder is the subject of any investigation or proceeding that could lead to that Party becoming a debarred entity or individual, an excluded entity or individual or a convicted entity or individual, such Party shall immediately notify the other Party, and the other Party shall have the right to immediately terminate this agreement in accordance with Section 12.2. This provision shall survive termination or expiration of this Agreement.

10.5. No Warranties . EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT OR ANY RELATED AGREEMENT, NEITHER PARTY NOR ANY OF ITS AFFILIATES MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, TO THE OTHER PARTY OR ANY OF ITS AFFILIATES, AND EACH PARTY HEREBY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES. EACH PARTY UNDERSTANDS THAT THE LICENSED COMPOUNDS AND PRODUCTS ARE THE SUBJECT OF ONGOING CLINICAL RESEARCH AND DEVELOPMENT, AND THAT NEITHER PARTY CAN ASSURE, AND EACH PARTY HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY, THAT THE DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION OF THE LICENSED COMPOUNDS AND PRODUCTS PURSUANT TO THIS AGREEMENT WILL RECEIVE REGULATORY APPROVAL OR WILL BE SAFE, EFFECTIVE, USEFUL OR SUCCESSFUL OR THAT ANY PARTICULAR SALES LEVEL WITH RESPECT TO THE PRODUCTS WILL BE ACHIEVED.

10.6. Covenants with Respect to Infinity Third Party Agreements .

10.6.1. Acknowledgement . AbbVie acknowledges and agrees, subject to the accuracy of the representations and warranties contained in Section 10.2.9, that (a) it has received a copy of the Existing Infinity Third Party Agreements existing as of the Execution Date and (b) all rights granted to and obligations (including any financial obligations) of AbbVie hereunder are subject to the terms and conditions of the Existing Infinity Third Party Agreements.

10.6.2. Compliance . AbbVie shall, and shall cause its Affiliates and Sublicensees to, comply in all material respects with the Infinity Third Party Agreements and take any action reasonably requested by Infinity, to prevent any potential material breach by AbbVie, its Affiliates or Sublicensees of any term of any Infinity Third Party Agreement. Without limiting the generality of the foregoing, the Third Party counterparty to any Infinity Third Party Agreement (and their licensors) shall have the same rights of audit and inspection with respect to AbbVie and its Affiliates and Sublicensees as granted by Infinity to such Third Party counterparty (or its licensor) pursuant to the applicable Infinity Third Party Agreement, provided , however , that (a) any audit conducted by a Third Party counterparty to any Infinity Third Party Agreement (or such party’s licensor) shall constitute an audit conducted by Infinity for purposes of Section 7.5 of this Agreement and (b) any such audit shall be limited to the scope set forth in Section 7.5 of this Agreement.

 

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10.6.3. Termination and Amendments . Infinity shall not, without AbbVie’s prior written consent (which shall not be unreasonably withheld), terminate, or enter into any amendment to, any Infinity Third Party Agreement which termination or amendment would have an adverse effect, in any material respect, on AbbVie’s rights or obligations under this Agreement or on the Development, Manufacture or Commercialization of the Products as contemplated hereunder. To the extent permitted under the relevant Infinity Third Party Agreement, Infinity shall provide AbbVie with a copy of all modifications to or amendments of the Infinity Third Party Agreements, regardless of whether AbbVie’s consent was required with respect thereto.

10.6.4. Breach of Infinity Third Party Agreements . Each Party shall use Diligent Efforts not to perform any acts or omissions that would constitute a breach of any of the Infinity Third Party Agreements which breach would have an adverse effect, in any material respect, on the Development, Manufacture or Commercialization of the Products as contemplated hereunder. Each Party shall provide the other promptly with notice of the occurrence of any such breach (or receipt of notice of an allegation of any such breach). AbbVie may deduct from payments due to Infinity any expenses incurred by AbbVie to cure any breach by Infinity of an Infinity Third Party Agreement, unless such breach was caused by AbbVie (including AbbVie’s breach of any obligation hereunder).

10.6.5. Intellikine Agreement .

(a) Subject to the terms of this Section 10.6.5, the sublicenses granted to AbbVie hereunder with respect to the Patent Rights and Know-How licensed to Infinity pursuant to the Intellikine Agreement shall terminate upon termination of the Intellikine Agreement (except as provided in Section 15.1(b) therein) and the provisions of Section 15.2 of the Intellikine Agreement shall, to the extent applicable to AbbVie, apply, except that any such sublicense to AbbVie of the rights granted to Infinity under Section 2.1 of the Intellikine Agreement to develop or commercialize Licensed Compounds or Products shall not terminate upon termination of the Intellikine Agreement but instead shall remain in full force and effect if AbbVie is not then in material breach of this Agreement and AbbVie provides to Intellikine within thirty (30) days after termination of the Intellikine Agreement a written agreement to be bound as AbbVie under the terms and conditions of the Intellikine Agreement as to the field and territory in which AbbVie has been granted rights under this Agreement.

(b) If, as a result of AbbVie’s acts or omissions, Infinity breaches its obligations under the Intellikine Agreement, Infinity shall provide AbbVie with prompt written notice of the actions or omissions by AbbVie causing such breach upon becoming aware of such breach (such actions and omissions, a “ Headlicense Breach ”). AbbVie shall have an opportunity to cure such Headlicense Breach in accordance with the terms set forth in Section 12.2.1 (but without any extension of the cure period therein), so long as AbbVie provides evidence to Infinity during such cure period of its actions to cure such breach. If AbbVie fails to cure its Headlicense Breach or to provide evidence of such actions in accordance with the preceding sentence, AbbVie’s Headlicense Breach shall be considered a material breach of this Agreement by AbbVie, which material breach shall not be subject to any further cure periods under Section 12.2.1 of this Agreement.

 

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(c) In the event the Intellikine Agreement is terminated for any reason other than a Headlicense Breach or other than any action by AbbVie giving rise to a right for Infinity to terminate this Agreement under Section 12.2.3 and AbbVie enters an agreement to be bound as AbbVie under the terms and conditions of the Intellikine Agreement or otherwise acquires or licenses rights from Intellikine permitting AbbVie to develop or commercialize Licensed Compounds or Products, with the right to sublicense such rights to Infinity, then all payments made or owing by AbbVie pursuant to such agreement shall be deducted from and recouped against all payments made or owing by AbbVie to Infinity under this Agreement.

10.7. Covenants with Respect to AbbVie Third Party Agreements .

10.7.1. Notwithstanding anything to the contrary herein, all rights, licenses and sublicenses granted by AbbVie to Infinity, and all obligations imposed on Infinity, hereunder or under any Related Agreement are subject to, and shall be construed in accordance with, the AbbVie Third Party Agreements, and nothing herein shall be interpreted in a manner inconsistent with Infinity’s obligations under any AbbVie Third Party Agreement.

10.7.2. Infinity shall, and shall cause its Affiliates and Sublicensees to, comply in all material respects with the AbbVie Third Party Agreements and take any action reasonably requested by AbbVie, to prevent any potential material breach by Infinity, its Affiliates or Sublicensees of any term of any AbbVie Third Party Agreement. Without limiting the generality of the foregoing, the Third Party counterparty to any AbbVie Third Party Agreement (and their licensors) shall have the same rights of audit and inspection with respect to Infinity and its Affiliates and Sublicensees as granted by AbbVie to such Third Party counterparty (or its licensor) pursuant to the applicable AbbVie Third Party Agreement, provided , however , that (a) any audit conducted by a Third Party counterparty to any AbbVie Third Party Agreement (or such party’s licensor) shall constitute an audit conducted by AbbVie for purposes of Section 7.5 of this Agreement and (b) any such audit shall be limited to the scope set forth in Section 7.5 of this Agreement.

10.7.3. AbbVie shall not, without Infinity’s prior written consent (which shall not be unreasonably withheld), terminate, or enter into any amendment to, any AbbVie Third Party Agreement which termination or amendment would have a material adverse effect on Infinity’s rights or obligations under this Agreement or on the Development, Manufacture or Commercialization of the Products as contemplated hereunder. To the extent permitted under the relevant AbbVie Third Party Agreement, AbbVie shall provide Infinity with a copy of all modifications to or amendments of the AbbVie Third Party Agreements, regardless of whether Infinity’s consent was required with respect thereto.

10.7.4. Notwithstanding anything to the contrary herein, the rights, licenses and sublicenses granted by AbbVie to Infinity in this Agreement or any Related Agreement are subject to the terms and conditions of the applicable AbbVie Third Party Agreements, and the rights granted to or retained by the counterparties thereunder or their licensors.

 

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10.7.5. Each Party shall use Diligent Efforts not to perform any acts or omissions that would constitute a breach of any of the AbbVie Third Party Agreements which breach would have a material adverse effect on the Development, Manufacture or Commercialization of the Products as contemplated hereunder. Each Party shall provide the other promptly with notice of the occurrence of any such breach (or receipt of notice of an allegation of any such breach).

10.7.6. AbbVie shall (a) use Diligent Efforts to comply with the terms of each AbbVie Third Party Agreement; and (b) promptly notify Infinity in writing if AbbVie receives any notice alleging breach with a AbbVie Third Party Agreement or terminating, or purporting to terminate, a AbbVie Third Party Agreement. In the event that AbbVie receives written notice alleging that it is in breach of any AbbVie Third Party Agreement, AbbVie shall advise Infinity thereof and provide Infinity with a copy of such notice to the extent permitted under such AbbVie Third Party Agreement. In the event that AbbVie does not cure or challenge the breach alleged in such notice (which may include causing the counterparty to such AbbVie Third Party Agreement to retract such allegation) by the date that is five (5) days before the date on which such counterparty would be permitted to terminate such AbbVie Third Party Agreement due to such breach, then Infinity shall have the right, to the extent practicable and to the extent permitted under such AbbVie Third Party Agreement, to remedy the situation alleged in such notice and AbbVie shall reimburse Infinity for any Out-of-Pocket Costs that Infinity reasonably incurs in remedying such breach.

10.8. Insurance . Each Party, at its own expense, shall maintain liability insurance (or self-insure) with respect to its activities hereunder in an amount consistent with industry standards. Each Party shall provide a certificate of insurance (or evidence of self-insurance) evidencing such coverage to the other Party upon request. Without limiting the foregoing, during the Term and thereafter for the period of time required below, each Party shall maintain on an ongoing basis comprehensive general liability insurance in the minimum amount of $[**] per occurrence and $[**] annual aggregate combined single limit for bodily injury and property damage liability; and products liability insurance (including contractual liability coverage on such Party’s indemnification obligations under this Agreement) in the amount of at least $[**] per occurrence and as an annual aggregate combined single limit for bodily injury and property damage liability; provided , however , that (a) prior to the initiation of any Clinical Study, the Party responsible for such Clinical Study shall secure and maintain in full force and effect clinical trial insurance in compliance with applicable Law in those countries where such Clinical Study is conducted, and (b) commencing not later than [**] days prior to the reasonably anticipated First Commercial Sale of a Licensed Compound or Product, and thereafter for the period of time required below, each Party shall obtain and maintain on an ongoing basis products liability insurance (including contractual liability coverage on such Party’s indemnification obligations under this Agreement) in the amount of at least $[**] per occurrence and as an annual aggregate combined single limit for bodily injury and property damage liability. All of such insurance coverage may be maintained through a self-insurance plan that substantially complies with the foregoing limits and requirements and may be satisfied through one or more policies, including an umbrella policy; provided, that such self-insurance is determined to be investment quality by a recognized rating agency such as Moody’s or Standard & Poor’s. Not later than [**] days following receipt of written request from a Party, the other Party shall provide to the requesting Party a letter(s) affirming appropriate self-insurance and/or a certificate of insurance evidencing such coverage in accordance with this Agreement. Each Party shall maintain such insurance or self-insurance coverage without interruption during the Term and for a period of [**] years thereafter, and, if

 

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applicable, shall provide certificates and/or letters evidencing such insurance coverage without interruption as reasonably requested during the period of time for which such coverage must be maintained. Each Party shall be provided at least [**] days’ prior written notice of any cancellation or material decrease in the other Party’s insurance coverage limits described above. Notwithstanding the foregoing, either Party’s failure to maintain adequate insurance shall not relieve that Party of its obligations set forth in this Agreement.

ARTICLE 11.

INDEMNIFICATION

11.1. General Indemnification By Infinity . Infinity shall indemnify and hold harmless AbbVie, its Affiliates and their respective directors, officers, employees and agents (collectively, the “ AbbVie Indemnified Parties ”), from, against and in respect of any and all Losses incurred or suffered by any AbbVie Indemnified Party to the extent resulting from: (a) any breach of, or inaccuracy in, any representation or warranty made by Infinity in this Agreement, or any breach or violation by Infinity of any covenant or agreement in this Agreement; (b) the negligence or intentional misconduct of, or violation of Law by, Infinity, any of its Affiliates or Sublicensees, or any of their respective directors, officers, employees and agents, in performing Infinity’s obligations or exercising Infinity’s rights under this Agreement; (c) activities conducted by Infinity or its Affiliates related to the Development, Manufacture, or other Exploitation of the Products or the Licensed Compounds anywhere in the world prior to the Execution Date, other than product liability claims; and (d) subject to Section 12.3.10, the Development, Commercialization, Manufacture, or other Exploitation of any Products or the Licensed Compounds anywhere in the world after the termination of this Agreement.

11.2. General Indemnification By AbbVie . AbbVie shall indemnify and hold harmless Infinity, its Affiliates and their respective directors, officers, employees and agents (collectively, the “ Infinity Indemnified Parties ”), from, against and in respect of any and all Losses incurred or suffered by any Infinity Indemnified Party to the extent resulting from: (a) any breach of, or inaccuracy in, any representation or warranty made by AbbVie in this Agreement, (b) any breach or violation by AbbVie of any covenant or agreement in this Agreement, or (c) the negligence or intentional misconduct of, or violation of Law by, AbbVie, any of its Affiliates or Sublicensees, or any of their respective directors, officers, employees and agents, in performing AbbVie’s obligations or exercising AbbVie’s rights under this Agreement.

11.3. Claims for General Indemnification . With respect to a Product Liability Action, Section 11.4, rather than this Section 11.3, shall apply to the extent set forth therein.

11.3.1. Notice . An Indemnified Party entitled to indemnification under Sections 11.1 or 11.2 shall give prompt written notification to the Indemnifying Party from whom indemnification is sought of the commencement of any Action by a Third Party for which indemnification may be sought (a “ Third Party Claim ”) or, if earlier, upon the assertion of such Third Party Claim by a Third Party; provided , however , that failure by an Indemnified Party to give notice of a Third Party Claim as provided in this Section 11.3.1 shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement, except and only to the extent that such Indemnifying Party is actually prejudiced as a result of such failure to give notice.

 

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11.3.2. Defense . Within [**] days after delivery of a notice of any Third Party Claim in accordance with Section 11.3.1, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense of such Third Party Claim with counsel reasonably satisfactory to the Indemnified Party. If the Indemnifying Party does not assume control of such defense, the Indemnified Party shall control such defense. The Party not controlling such defense may participate therein at its own expense.

11.3.3. Cooperation . The Party controlling the defense of any Third Party Claim shall keep the other Party advised of the status of such Third Party Claim and the defense thereof and shall reasonably consider recommendations made by the other Party with respect thereto. The other Party shall reasonably cooperate with the Party controlling such defense and its Affiliates and agents in defense of the Third Party Claim, with all Out-of-Pocket Costs of such cooperation to be borne by the Party controlling such defense.

11.3.4. Settlement . The Indemnified Party shall not agree to any settlement of such Third Party Claim without the prior written consent of the Indemnifying Party, which shall not be unreasonably withheld. The Indemnifying Party shall not, without the prior written consent of the Indemnified Party, which shall not be unreasonably withheld, agree to any settlement of such Third Party Claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto or that imposes any liability or obligation on the Indemnified Party.

11.3.5. Allocation of Costs . For clarity, all costs incurred pursuant to this Section 11.3 shall be excluded from Development Costs and Allowable Expenses.

11.4. Conduct of Product Liability Actions .

11.4.1. Each Party shall promptly notify the other if any Third Party files a Product Liability Action against such Party or any of its Affiliates. In the event of a Product Liability Action against a single Party, the unnamed Party shall have the right, in the unnamed Party’s sole discretion, to join or otherwise participate in such Action with legal counsel selected by the unnamed Party and reasonably acceptable to the named Party. The Party named in such Product Liability Action shall have the right to control the defense of the action, but shall notify and keep the unnamed Party apprised in writing of such action and shall consider and take into account the unnamed Party’s reasonable interests and requests and suggestions regarding the defense of such action. In the event of a Product Liability Action against both Parties, the Parties shall mutually agree upon which Party shall control the response to such Product Liability Action.

11.4.2. The unnamed Party of a Product Liability Action shall reasonably cooperate with the named Party in the preparation and formulation of a defense to such Product Liability Action, and in taking other steps reasonably necessary to respond to such Product Liability Action. The named Party shall have the sole and exclusive right to select its counsel for the defense to such Product Liability Action. If required under applicable Law in order for the named Party to maintain a suit in response to such Product Liability Action, the unnamed Party shall join as a party to the suit. The unnamed Party shall also have the right to participate and be represented in any such suit by its own counsel. The named Party shall not settle or compromise any Product Liability Action without the consent of the other Party, which consent shall not be unreasonably withheld.

 

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11.4.3. With respect to Product Liability Actions arising in the Ex-US Territory, except with respect to such portion (if any) of Product Liability Costs that are Losses entitled to indemnification under Sections 11.1 or 11.2, which shall be solely borne by the relevant Indemnifying Party, all Product Liability Costs related to such actions shall be borne by the Party incurring such costs. With respect to Product Liability Actions arising in the US, except with respect to such portion (if any) of Product Liability Costs that are Losses entitled to indemnification under Sections 11.1 or 11.2, which shall be solely borne by the relevant Indemnifying Party, all Product Liability Costs related to such actions shall be considered “ Shared Product Liability Costs ” and included in Allowable Expenses.

ARTICLE 12.

TERM AND TERMINATION

12.1. Term . Unless terminated earlier in accordance with this ARTICLE 12, this Agreement becomes effective as of the Effective Date and shall remain in force for the period commencing on the Effective Date and ending upon the cessation of all Development, Manufacturing and Commercialization activities with respect to all Licensed Compounds and Products (the “ Term ”).

12.2. Early Termination .

12.2.1. Termination for Material Breach .

(a) Termination for Material Breach . Upon (i) any material breach of this Agreement by Infinity or (ii) any material breach of this Agreement by AbbVie, other than a material breach as set forth below in Section 12.2.1(c) or 12.2.1(d) (the Party so allegedly breaching being the “ Breaching Party ”), the other Party (the “ Non-Breaching Party ”) shall have the right, but not the obligation, to terminate this Agreement in its entirety by providing [**] days written notice to the Breaching Party in the case of a material breach of a payment obligation and [**] days written notice to the Breaching Party in the case of any other material breach, which notice shall, in each case (a) expressly reference this Section 12.2.1, (b) reasonably describe the alleged breach which is the basis of such termination, and (c) clearly state the Non-Breaching Party’s intent to terminate this Agreement if the alleged breach is not cured within the applicable cure period. Notwithstanding the foregoing, (x) if the alleged material breach by AbbVie is that it has failed to use Diligent Efforts to seek Regulatory Approval for or Commercialize the Product in a particular country in the Ex-US Territory under Section 5.1.3(b), then Infinity shall have the right to terminate this Agreement solely with respect to such country (and not in its entirety); and (y) AbbVie may elect, in lieu of terminating this Agreement, to proceed as set forth below in Section 12.2.1(b) and 12.2.1(d) in the case of material breach by Infinity. The termination shall become effective at the end of the notice period unless the Breaching Party cures such breach during such notice period; provided , that the Non-Breaching Party may, by notice to the Breaching Party, designate a later date for such termination in order to facilitate an orderly transition of activities relating to the Product. Notwithstanding the foregoing, (1) if such material breach (other than a payment breach), by its nature, is curable, but is not reasonably curable within the applicable cure period, then such cure period shall be extended if the Breaching Party provides a written plan for curing such breach to the Non-Breaching Party and uses Diligent Efforts to cure such breach in accordance with such written plan; provided , that no such extension shall exceed [**] days without

 

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the consent of the Non-Breaching Party; and (2) if the Breaching Party disputes that it has materially breached this Agreement, the dispute shall be resolved pursuant to ARTICLE 13. If, as a result of the application of such dispute resolution procedures, the Breaching Party is determined to be in material breach of this Agreement (an “ Adverse Ruling ”), then if the Breaching Party fails to cure such material breach within [**] days after such ruling (whether or not such actions are specified by the Adverse Ruling) (or [**] days after such ruling in the case of a payment breach), then the Non-Breaching Party may terminate this Agreement upon written notice to the Breaching Party as provided in this Section 12.2.1(a).

(b) Breach by Infinity of its Development Obligations . If Infinity materially breaches its obligation under Section 4.3.1 to use Diligent Efforts to conduct the Development of the Licensed Compound, including a material breach of its obligations under any Regulatory Approval, then following the notice and cure periods, and where applicable, any Adverse Ruling, all as described in Section 12.2.1(a), AbbVie shall have the right, in lieu of terminating this Agreement in its entirety, to terminate only that portion of this Agreement that provides Infinity with the right to conduct Development activities and to thereafter assume the conduct of all Development activities allocated to Infinity under the GDP upon thirty (30) days written notice to Infinity (or such longer period as AbbVie may determine is needed to implement such transition). In such event, the Development Costs for such assumed Development activities shall remain solely the obligation of Infinity, up to the Development Threshold, and thereafter, shared equally by the Parties in accordance with Section 4.6.1. To the extent Infinity fails to fund such assumed Development activities by AbbVie, AbbVie shall, in addition to any other remedies (including the right to terminate this Agreement under Section 12.2.1(a)), fund such amounts consistent with the then-current GDP and Development Budget, and such amounts shall be deducted and recouped from any amounts thereafter owing to Infinity. No assumption of Development activities shall alter Infinity’s rights to share in the Net Profit or Loss in the US, or receive milestones and royalties set forth in ARTICLE 7 and Schedule 7 or any other economic provisions of this Agreement.

(c) Breach by AbbVie of its Development Obligations . If AbbVie materially breaches its Development diligence obligations under Section 4.3.1, then Infinity shall not have the right to terminate this Agreement, but rather Infinity shall have the right to terminate only that portion of this Agreement that provides AbbVie with the right to conduct Development activities, and thereafter assume the conduct of all such Development activities under the GDP, following the notice and cure periods, and where applicable any Adverse Ruling, all described in Section 12.2.1(a), upon thirty (30) days written notice to AbbVie; provided , however , that in no event will Infinity have the right to conduct any Clinical Study that includes the AbbVie Combination Compound, in combination with the Licensed Compound or cast a deciding vote with respect to such matters. Such assumption will not affect the allocation of Development Costs of such assumed Development activities as set forth in Section 4.6.1, nor any other economic provisions of this Agreement.

(d) Breach of Commercialization Obligations by Either Party . If (i) AbbVie materially breaches its obligations to use Diligent Efforts to Co-Promote the Product in the US, or (ii) Infinity materially breaches its obligations to use Diligent Efforts to either (x) Co-Promote the Product, (y) distribute and sell the Product, or (z) provide patient services, in each case, in the US, then the Non-Breaching Party shall have the right, following the notice and cure

 

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periods, and where applicable any Adverse Ruling, all described in Section 12.2.1(a), to (A) terminate only that portion of this Agreement that provides the Breaching Party with the right to so conduct just those Commercialization activities that gave rise to such material breach, and thereafter assume the right to conduct just such Commercialization activities itself (e.g., in the case of uncured material breach by Infinity of its obligations to distribute and sell the Product, AbbVie would have the right to terminate Infinity’s rights to conduct such activities and to assume such activities, the breaching Party would have the right continue conducting all other Commercialization activities for which it is responsible hereunder) and (B) notwithstanding Section 2.9.3, cast a deciding vote with respect to all matters referred to the Executive Officers by the JSC pursuant to Section 2.9.2 relating to such Commercialization activities under this Agreement consistent with such Party’s diligence obligations under this Agreement. If AbbVie terminates Infinity’s rights to distribute and sell the Product in the US Territory in accordance with Section 5.5, then AbbVie shall distribute and sell the Product and the terms of Section 7.2.1 and Section 7.5 shall apply mutatis mutandis to the Parties.

(e) Recoupment . If a Party materially breaches this Agreement and the other Party is awarded damages pursuant to a dispute resolution procedure under ARTICLE 13, then the Party awarded such damages, in addition to any other remedies, shall recoup any unrecovered damages against payments due the breaching Party under this Agreement.

12.2.2. Termination by AbbVie Unilaterally .

(a) AbbVie may, upon ninety (90) days’ prior written notice to Infinity, which notice expressly references this Section 12.2.2, unilaterally terminate this Agreement without cause.

(b) If AbbVie provides notice of termination pursuant to Section 12.2.2(a), this Agreement shall remain in full force and effect until the effective date of such termination. In the event of termination pursuant to Section 12.2.2(a), during the period from the date of AbbVie’s notice of termination until the effective date of termination, all licenses and rights granted to AbbVie under this Agreement shall be non-exclusive.

12.2.3. Challenges of Infinity Patent Rights . If AbbVie or any of its Affiliates or Sublicensees (a) commences or participates in any Action (including any patent opposition, re-examination or invalidation proceeding), or otherwise asserts any claim, challenging or denying the validity or enforceability of any Infinity Patent Right or any claim thereof or (b) actively and knowingly assists any Person in bringing or prosecuting any Action (including any patent opposition, re-examination or invalidation proceeding) challenging or denying the validity or enforceability of any Infinity Patent Right or any claim thereof (each of (a) and (b), a “ Patent Challenge ”), then, to the extent permitted by Law, Infinity may, in its sole discretion, give at least thirty (30) days prior written notice to AbbVie that Infinity may terminate this Agreement, and, unless AbbVie, its Affiliates and Sublicensees, as applicable, withdraw or cause to be withdrawn all such challenges (or in the case of ex-parte proceedings, multi-party proceedings or other Patent Challenges that AbbVie, its Affiliate or Sublicensee do not have the power to unilaterally withdraw or cause to be withdrawn, AbbVie, its Affiliates and Sublicensees cease actively assisting any other party to such Patent Challenge and, to the extent AbbVie, its Affiliate or Sublicensee is a party to such Patent Challenge, it withdraws from such Patent Challenge) within thirty (30) days after AbbVie’s receipt of notice regarding such Patent Challenge, Infinity may terminate this Agreement by providing written notice thereof to AbbVie.

 

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12.2.4. Termination for Insolvency . In the event that either Party (a) files for protection under bankruptcy or insolvency laws, (b) makes an assignment for the benefit of creditors, (c) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is not discharged within ninety (90) days after such filing, (d) proposes a written agreement of composition or extension of its debts, (e) proposes or is a party to any dissolution or liquidation, (f) files a petition under any bankruptcy or insolvency act or has any such petition filed against that is not discharged within sixty (60) days of the filing thereof, or (g) admits in writing its inability generally to meet its obligations as they fall due in the general course, then the other Party may terminate this Agreement in its entirety effective immediately upon written notice to such Party.

12.3. Effects of Termination . In the event of expiration or termination of this Agreement, in its entirety or with respect to any country, for any reason, the provisions of this Section 12.3 shall apply, with respect to the terminated country or this Agreement in its entirety, as applicable.

12.3.1. Effects of Termination Generally . Promptly following the receipt of any notice of termination in the entirety pursuant to Section 10.6.5(b), 12.2.1, 12.2.2, 12.2.3 or 12.2.4, Infinity shall prepare, with AbbVie’s reasonable cooperation (as reasonably requested by Infinity), and the Parties shall negotiate, a termination and wind-down plan that will include, at a minimum, a plan for accomplishing the activities described in this Section 12.3 (“ Termination and Wind-Down Plan ”). Except as set forth in this ARTICLE 12, the Parties acknowledge and agree that the Parties’ obligations under this Agreement generally, including the GDP and all Commercialization Plans, shall terminate conclusively and neither Party shall have any further rights or obligations under this Agreement from and after the effective date of termination, except as set forth in this Section 12.2.1; provided that if this Agreement is terminated with respect to a particular country only, then such rights and obligations will terminate only to the extent they relate solely to the terminated country. If AbbVie has provided a notice of termination under Section 12.2.2(a), Infinity may shorten the termination notice period under Section 12.2.2(a) in its discretion.

12.3.2. Accrued Obligations . Expiration or termination of this Agreement for any reason shall not release either Party from any obligation or liability which, on the effective date of such expiration or termination, has already accrued to the other Party or which is attributable to a period prior to such expiration or termination; provided, that no milestone payment shall be due pursuant to Section 7.1 if the event triggering such milestone payment occurs during the period following a notice of termination but before the effective date of termination.

12.3.3. Non-Exclusive Remedy . Notwithstanding anything herein to the contrary, termination of this Agreement in whole or in part by a Party shall be without prejudice to other remedies any Party may have at law or equity.

12.3.4. Survival . This Section 12.3.4, the provisions set forth in the following Sections, as well as, to the extent applicable, any other Sections or defined terms referred to in such Sections or Articles or necessary to give them effect, shall survive any expiration or termination of this Agreement in its entirety: Section 3.2.4 ( [**]); Section 8.1 ( Ownership of Inventions ); Section

 

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8.1.2 ( [**] Prosecution) (solely with respect to [**]), Section 8.3 ( Third Party Infringement) (solely with respect to [**]), Section 8.7.1 ( Retained Rights in Corporate Marks and Logos ); Section 8.7.2(c) (Ownership); ARTICLE 9 ( Confidentiality ); ARTICLE 10 ( Representations and Warranties ); ARTICLE 11 ( Indemnification ); Section 12.3 ( Effects of Termination ); Section 14.4 ( Choice of Law ); Section 14.5 ( Notices ); Section 14.12 ( No Consequential or Punitive Damages ); Section 14.20 ( Records Generally ); ARTICLE 13 ( Alternative Dispute Resolution ); and, to the extent that any obligations have accrued prior to termination for any reason under this ARTICLE 12 or otherwise extend beyond the effective date of termination (as expressly set forth therein), the payment provisions in ARTICLE 7 ( Financial Provisions ). Furthermore, any other provisions required to interpret the Parties’ rights and obligations under this Agreement, including applicable definitions in ARTICLE 1, shall survive to the extent required. Except as otherwise provided in this Section 12.3.4, all rights and obligations of the Parties under this Agreement, including any licenses granted hereunder, shall terminate upon expiration or termination of this Agreement in its entirety or solely with respect to the terminated country, as the case may be, for any reason.

12.3.5. Summary of Activities . Within [**] days after the notice of termination of this Agreement is provided, AbbVie shall provide to Infinity a comprehensive report of the status and results of its, and its Affiliates’ and Sublicensees’ activities under this Agreement, including its and its Affiliates’ and Sublicensees’ Development, Manufacturing and Commercialization activities, if any, with respect to Licensed Compounds and Products in the country(ies) or territory where such termination has occurred, as applicable.

12.3.6. Regulatory Filings and Regulatory Approvals . At Infinity’s request, AbbVie shall, promptly following the effectiveness of such termination, assign and transfer to Infinity, all Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations for Products that are held or controlled by or under authority of AbbVie or its Affiliates or Sublicensees as of the effective date of termination, with respect to the terminated country or the Territory, as the case may be, and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations to Infinity. If this Agreement is terminated in its entirety, AbbVie shall also promptly transfer control of and responsibility for maintaining the global safety database for Products to Infinity (if previously held by AbbVie or its Affiliates), and Infinity shall accept such transfer and responsibility. If applicable Law prevents or delays the transfer of ownership of any such Regulatory Filing, filing for Pricing and Reimbursement Approval or Marketing Authorizations to Infinity, AbbVie shall grant, and does hereby grant, to Infinity an exclusive and irrevocable right of access and Right of Reference to such Regulatory Filing, filing for Pricing and Reimbursement Approval and Marketing Authorizations for the Products in the Territory or the terminated country, as the case may be, and shall reasonably cooperate to make the benefits of such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations available to Infinity or its designee(s). Infinity shall have the right to grant licenses or sublicenses (as applicable) under the rights granted to it under this Section 12.3.6 to its Affiliates and Third Parties, through multiple tiers. For clarity, the rights and obligations in this Section 12.3.6 shall not apply to Regulatory Filings and Regulatory Approvals relating to or involving AbbVie Combination Compounds.

 

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12.3.7. Technology Licenses .

(a) Upon the effectiveness of any termination of this Agreement, (i) all rights and licenses granted by Infinity hereunder shall immediately terminate, in their entirety or solely in the terminated country(ies), as applicable, and (ii) AbbVie shall and hereby does grant to Infinity, effective upon the effective date of any such termination, an exclusive, royalty-bearing, perpetual, irrevocable license under the AbbVie Intellectual Property to Develop, Manufacture and Commercialize Licensed Compounds and Products in the Field in the Territory or the terminated country(ies), as applicable; provided that: (i) the foregoing license shall exclude any license or other rights with respect to any active ingredient that is not a Licensed Compound and which is covered by Patents Controlled by AbbVie or any of its Affiliates, including, for clarity, AbbVie Combination Compound; (ii) Infinity shall be responsible for (A) making any payments (including royalties, milestones and other amounts) payable by AbbVie to Third Parties under any Third Party agreements with respect to the AbbVie Patents and AbbVie Know-How that are the subject of the license granted by AbbVie to Infinity pursuant to this Section 12.3.6 and that arise out of the Exploitation of the Products in the Territory of the terminated country(ies), as applicable, by Infinity or its Affiliate or Sublicensees by making such payments directly to AbbVie and, in each instance, Infinity shall make the requisite payments to AbbVie and provide the necessary reporting information to AbbVie in sufficient time to enable AbbVie to comply with its obligations under such Third Party agreements, and (B) complying with any other obligations included in any such Third Party agreements that are applicable to the grant to AbbVie of such license or to the exercise of such license by Infinity or any of its Affiliates or Sublicensees; and (iii) AbbVie shall be responsible for paying or providing to any such Third Party any payments or reports made or provided by Infinity under this Section 12.3.7. Infinity shall have the right to grant sublicenses under the rights granted to it under this Section 12.3.7 to its Affiliates and Third Parties, through multiple tiers, except as may be limited by any applicable AbbVie Third Party Agreement.

(b) In consideration of the license under Section 12.3.7 and payments then made to date by AbbVie under this Agreement, Infinity shall pay AbbVie a royalty on Net Sales of each Product in each country of the Territory or the terminated country(ies), as applicable, during the Post-Termination Royalty Term for such Product in such country(ies) in the following circumstances and at the following rates: (A) if this Agreement is terminated by AbbVie under Section 12.2.1(a) for Infinity’s material breach, the royalty rate will be (x) [**] percent ([**]%) of Net Sales [**] but such royalties will be paid only until the cumulative royalty payments under this Section 12.3.7 equal [**] (B) if this Agreement is terminated by Infinity under Section 12.2.1(a) (in its entirety or with respect to a particular country(ies)) for AbbVie’s material breach, the royalty rate will be [**] percent ([**]%) of Net Sales. For purposes of this Section 12.3.6, the definition of “Net Sales” and the terms of ARTICLE 7 shall apply mutatis mutandis to the calculation (including royalty reduction), payment, recording, and auditing of Infinity’s obligations to pay royalties under this Section. For purposes of this Section, “ Post-Termination Royalty Term ” means, with respect to each Product and each country or other jurisdiction in the Territory or terminated country(ies), as applicable, the period beginning on the date of the First Sale of such Product in such country or other jurisdiction after termination of this Agreement and ending on [**].

12.3.8. Survival of Sublicenses . In the event of a termination of this Agreement while a sublicense of rights granted by AbbVie with respect to the terminated country is in effect, the terms of this Section 12.3.8 shall apply, provided , that the applicable Sublicensee is not in material breach of the applicable sublicense agreement. In such event, (i) all of such Sublicensee’s obligations under the applicable sublicense agreement to AbbVie shall remain in effect as

 

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obligations to Infinity and shall be enforceable solely by Infinity as a third party beneficiary, (ii) such Sublicensee’s rights under the sublicense agreement that do not exceed and are not inconsistent with Infinity’s obligations to AbbVie under this Agreement, whether in scope, duration, nature or otherwise, shall survive termination; provided , that the foregoing shall in no way be interpreted to increase the scope, duration, territory or other aspect of the rights sublicensed to such Sublicensee and (iii) all of AbbVie’s rights under the sublicense agreement shall remain in effect, may be exercised solely by Infinity and shall inure to the exclusive benefit of Infinity.

12.3.9. Marks and Domains . Effective upon the effective date of termination, AbbVie hereby assigns and shall cause to be assigned to Infinity all rights in and to any Product Trademarks in the terminated country(ies) or worldwide, as applicable, and all Internet domain names for the terminated country incorporating any Product Trademark as its URL address or any part of such address. It is understood that such assignment shall not include the name of AbbVie or any of its Affiliates, nor the corporate logo, service mark, or trademark for AbbVie or for any of its Affiliates as a corporate entity.

12.3.10. Governance during Wind-Down . Beginning on the date of notice of termination of this Agreement in its entirety and until such termination becomes effective, Section 2.9 and ARTICLE 13 shall no longer apply with respect to any decisions of any Committee or Working Group with respect to the terminated country or this Agreement in its entirety, as applicable, and Infinity shall have the right to cast a deciding vote with respect to any matter to be decided by any Committee or Working Groups, which deciding vote shall be deemed the decision of such Committee or Working Group; provided , however , that Infinity may not cast such a deciding vote (a) to impose additional responsibilities on AbbVie under the GDP or a Commercialization Plan of a materially different nature or magnitude than AbbVie’s responsibilities thereunder prior to termination, or (b) to increase the budget included within the Development Budget or any Commercialization Budget, as last approved by the JSC.

12.3.11. Post-Termination Shared Product Liability Costs . In the event that Infinity terminates this Agreement in its entirety pursuant to Section 12.2.1 (Termination for Material Breach) or AbbVie terminates this Agreement pursuant to Section 12.2.2 (Termination by AbbVie Unilaterally), a Party or any of its Affiliates incurs any Shared Product Liability Costs after the Term, which Shared Product Liability Costs are attributable to sales or other activities under this Agreement during the Term (or with respect to the terminated country prior to termination with respect to such country only), each Party shall be responsible for fifty percent (50%) of such Shared Product Liability Costs. Each Party will promptly pay the other Party its share of any such Shared Product Liability Costs after receipt of detailed supporting documentation evidencing such Shared Product Liability Costs.

12.3.12. On-Going Trials . In the event that any Clinical Study with respect to a AbbVie Combination Compound has been Commenced and is on-going as of the effective date of any termination of this Agreement by Infinity in its entirety pursuant to Section 12.1 (Termination for Material Breach) or by AbbVie pursuant to Section 12.2.2 (Termination by AbbVie Unilaterally), AbbVie shall continue to fund fifty percent (50%) of the Combination Study Costs of such Clinical Study and conduct such Clinical Study. In addition, if there are any Clinical Studies being conducted by or under the authority of AbbVie or any of its Affiliates at the time of notice of termination (other than Combination Clinical Studies), with respect to a Product that has

 

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been Commenced and is on-going as of the effective date of the termination of this Agreement in its entirety (an “ On-Going Clinical Study ”), AbbVie shall, as Infinity may request, (a) promptly transition to Infinity or its designee some or all of such On-Going Clinical Studies and the activities related to or supporting such trials, (b) unless this Agreement has been terminated by AbbVie pursuant to Section 12.2.1 (Termination for Material Breach), continue to conduct such On-Going Clinical Studies for a period requested by Infinity up to a maximum of [**] after the effective date of such termination, or (c) terminate such On-Going Clinical Studies in a manner consistent with applicable Laws; provided , however , that in the event that Infinity, AbbVie, an institutional review board or independent safety board determines that an On-Going Clinical Study being run by AbbVie or any of its Affiliates would pose an unacceptable safety risk for subjects or patients participating in such On-Going Clinical Study, then AbbVie shall not be obligated to continue such Clinical Study and AbbVie shall provide Infinity with a full explanation of the safety issue concerns raised by such institutional review board or independent safety board and, if requested by Infinity, reasonable documentation thereof and such additional information as may be necessary to permit Infinity to fully understand and assess such safety issues.

12.3.13. Commercialization Wind-Down . This Section 12.3.13 shall apply unless this Agreement is terminated by AbbVie pursuant to Section 12.2.1: To the extent requested by Infinity, AbbVie and its Affiliates and Sublicensees shall reasonably cooperate with Infinity and its designees to facilitate a smooth, orderly and prompt transition to Infinity or its designees of Commercialization activities of Products already commercially sold by AbbVie in such countries in which AbbVie was distributing and selling Products as of the effective date of termination in the terminated country (or anywhere in the Territory, if this Agreement is terminated in its entirety) (the “ Launched Products ”), in accordance with the terms and conditions of this Agreement and as set forth in the applicable, then-current Commercialization Plan, for a period requested by Infinity, not to exceed [**] from the effective date of such expiration or termination (the “ Agreement Wind-Down Period ”); provided , that Infinity may terminate such activities during the Agreement Wind-Down Period upon [**] days’ notice to AbbVie. If Infinity requests that AbbVie and its Affiliates and Sublicensees distribute and sell the Launched Products during the Agreement Wind-Down Period, Infinity shall grant, and hereby grants, to AbbVie for the duration of the Agreement Wind-Down Period (or, if earlier, until Infinity terminates such by notice as described in the preceding sentence), a non-exclusive license under the Infinity Intellectual Property to Commercialize and have Commercialized the Launched Products in the applicable countries in the ex-US Territory, solely to perform such distribution and sale with respect to Launched Products in countries requested by Infinity. If Infinity requests that AbbVie and its Affiliates and Sublicensees distribute and sell the Launched Products during the Agreement Wind-Down Period, Infinity shall not purchase existing inventory of AbbVie pursuant to Section 12.3.15 in an amount that would prevent AbbVie from continuing such distribution and sales. For clarity, following the effective date of termination of this Agreement in its entirety, the Parties’ obligations under Section 3.7 shall terminate, and Infinity shall have the right to engage one or more other partners or distributors of Products in all or part of the Territory during the Agreement Wind-Down Period. Any Products sold or disposed by AbbVie or its Affiliates or Sublicensees during the Agreement Wind-Down Period shall be subject to the applicable payments under the Financial Exhibit. After the Agreement Wind-Down Period, AbbVie and its Affiliates and Sublicensees shall no longer have a right to sell Products hereunder.

 

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12.3.14. Customer Information . AbbVie shall, and shall ensure that its Affiliates and Sublicensees, transfer and assign to, and hereby does assign to Infinity or its designee(s) all promotional materials, customer data, competitive intelligence data, market research and other materials, information or data related to the marketing, promotion or sale of Licensed Compounds or Products in the Territory or the terminated country, as applicable, (“ Marketing-Related Materials ”) in their possession or control as of the effective date of such termination, to the extent necessary or reasonably useful for the Commercialization of Licensed Compounds or Products in the Territory or terminated country, as applicable.

12.3.15. Return of Confidential Information . Within [**] days after the effective date of termination of this Agreement in its entirety, or earlier if requested by a Party, each Party shall, and cause its Affiliates to (a) destroy, all tangible items solely comprising, bearing or containing any Confidential Information of the other Party that are in such first Party’s or its Affiliates’ possession or control, and provide written certification of such destruction, or (b) prepare such tangible items of the other Party’s Confidential Information for shipment to such other Party, as such other Party may direct, at the first Party’s expense; provided , that, in any event, (x) each Party may retain one copy of the Confidential Information of the other Party to the extent necessary to perform its obligations that survive expiration or termination of this Agreement; (y) such first Party may retain one copy of such Confidential Information of the other Party for its legal archives; and (z) Infinity may retain AbbVie’s Confidential Information to the extent necessary for Infinity to exercise its rights that survive expiration or termination of this Agreement.

12.3.16. Transition; Manufacturing; Inventory . AbbVie and its Affiliates shall reasonably cooperate with Infinity and its designees to facilitate a smooth, orderly and prompt transition to Infinity or its designees of the activities with respect to Licensed Compounds and Products, including any ongoing Development, Manufacturing and Commercialization of Licensed Compounds and Products, for a period requested by Infinity (not to exceed [**] after the Term). Except as expressly stated in this ARTICLE 12, all out-of-pocket costs incurred by the Parties in connection with transition activities conducted under this ARTICLE 12 shall be borne by the AbbVie. If AbbVie or its Affiliate Manufactured or had Manufactured any Licensed Compound or Product at the time of termination, then AbbVie (or its Affiliate) shall continue to provide for Manufacturing of such Licensed Compound or Product for Infinity, at [**] therefor, from the effective date of such termination until such time as Infinity is able, using Diligent Efforts to do so, to secure an acceptable alternative manufacturing source from which sufficient quantities of such Licensed Compound or Product may be procured and legally sold throughout the Territory, but in any event no longer than [**] months after the effective date of termination. If a Sublicensee Manufactures a Licensed Compound or Product on AbbVie’s or its Affiliate’s behalf at the time of termination, upon request of Infinity, AbbVie shall use Diligent Efforts to transfer the applicable Sublicense to Infinity on or promptly after the effective date of termination. Upon the expiration of such period or the expiration or termination of this Agreement, Infinity shall have the right to purchase from AbbVie, and AbbVie shall sell to Infinity if requested by Infinity, all of AbbVie’s and its Affiliate’s existing inventory of Licensed Compounds and Products at a price equal to [**] for such Licensed Compounds and Products (taking into account the Supply Price for any portion of such inventory previously shared by AbbVie under this Agreement).

 

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12.3.17. Cooperation . Each Party shall cause its Affiliates and Sublicensees to comply with the obligations in this Section 12.3.

12.3.18. Cross Termination . The Supply Agreements shall terminate upon termination of this Agreement, with the relevant sections therein stated to survive termination so surviving.

ARTICLE 13.

ALTERNATIVE DISPUTE RESOLUTION

13.1. Alternative Dispute Resolution . Except for the Excluded Matters and the Excluded Claims (including those matters described in the final sentence of Section 2.9.2), any dispute, claim or controversy arising from or related in any way to this Agreement or the interpretation, application, breach, termination or validity thereof (a “ Dispute ”), in each case which, if it is a dispute within the scope of Section 2.9 (other than an Excluded Matter), has been referred to the Executive Officers for resolution in accordance with Section 2.9 and has not been resolved within the time specified in Section 2.9, will be resolved by alternative dispute resolution (“ ADR ”) as follows:

13.1.1. The place of arbitration shall be New York, New York, and all proceedings and communications shall be in English.

13.1.2. To begin an ADR proceeding, a Party shall provide written notice to the other Party of the Dispute to be resolved by ADR. Within [**] days after its receipt of such notice, the other Party may, by written notice to the Party initiating the ADR, add additional issues to be resolved within the same ADR. Thereafter, no new issues can be added absent consent of the tribunal, which consent shall be granted for good cause. In assessing whether good cause exists for permitting the addition of new issues, the tribunal shall consider all relevant factors, including whether justice is served by allowing the addition of new issues, whether a Party unduly delayed in seeking to add a new issue, and whether the other Party would be unfairly prejudiced by the addition of the new issues. The ADR shall be administered by Judicial Arbitration and Mediation Services, Inc. (“ JAMS ”) pursuant to the then-current JAMS Comprehensive Rules and Procedures, except as modified under this Section 13.1.

13.1.3. Within [**] days following the initiation of the ADR proceeding, the Parties shall select a mutually acceptable independent, impartial and conflicts-free neutral from the JAMS list of neutrals to preside in the resolution of all issues in this ADR proceeding. If the Parties are unable to agree on a mutually acceptable neutral (who does not need to be from the JAMS list) within such period, each Party will select one (1) independent, impartial and conflicts-free neutral and, within [**] days thereafter, those two neutrals will select a third independent, impartial and conflicts-free neutral from the JAMS list of neutrals to preside as the chair of the panel of such three neutrals (such neutral(s), the “ Neutral ”). None of the neutrals selected may be current or former employees, officers or directors of either Party or its Affiliates. Furthermore, the following provisions shall supplement (but not replace) the provisions of the JAMS Comprehensive Rules and Procedures regarding neutrality:

 

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(a) A person shall be deemed to have a conflict, and shall not be appointed as a Neutral absent the consent of both parties, if such person (i) has presided over an evidentiary hearing relating to, or issued a ruling on, the merits of a dispute, involving either Party; (ii) has conducted a mediation involving either Party, or (iii) has been retained to perform and has performed professional services for either Party within the last 10 years. The “merits of a dispute” are matters substantially related to the substance of the underlying claim, and do not include procedural or discovery-related matters;

(b) A person shall be deemed to have a conflict, and shall not be appointed as a Neutral absent consent of both parties, if such person previously served as a party-appointed arbitrator appointed by either Party, or by any party represented in a previous arbitration by one of the law firms representing either Party in any Dispute referred to ADR under this Agreement, if the governing rules of such arbitration did not require such arbitrator to be impartial and independent; and

(c) Neither Party nor any person acting on behalf of a Party may have any ex parte communications with any Neutral at any time before or during the proceedings. Notwithstanding JAMS Comprehensive Rules and Procedures, prohibited ex parte communications shall include, advising the candidate of the general nature of the controversy and of the anticipated proceedings and to discuss the candidate’s qualifications, availability or independence in relation to the Parties.

13.1.4. No earlier than [**] days or later than [**] days after selection, the Neutral shall hold a hearing to resolve each of the issues identified by the Parties. The ADR proceeding shall take place at a location in New York, New York to be agreed upon by the Parties. If the Parties cannot agree, the Neutral shall designate a location other than the principal place of business of either Party or any of their Affiliates.

13.1.5. At least [**] days prior to the hearing, each Party shall submit the following to the other Party and the Neutral:

(a) a copy of all exhibits on which such Party intends to rely in any oral or written presentation to the Neutral;

(b) a list of any witnesses such Party intends to call at the hearing, and a short summary of the anticipated testimony of each witness;

(c) a proposed ruling on each issue to be resolved, together with a request for a specific damage award or other remedy for each issue. The proposed ruling shall not contain any recitation of the facts or any legal arguments, and the proposed remedy shall not include any punitive damages. The proposed ruling and the proposed remedy collectively shall not exceed [**]; and

(d) a brief in support of such Party’s proposed rulings and remedies; provided , that the brief shall not exceed [**] pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.

 

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13.2. Each Party shall be entitled to [**]. The Neutral can permit additional discovery, subject to the limits specified below, where such discovery is reasonably calculated to lead to admissible evidence regarding liability or damages, and with respect to a request for an additional deposition, the necessity of an additional deposition shall be determined by the Neutral based upon the reasonable need for the requested information, the availability of other discovery options and the burdensomeness of the request on the opposing Parties and the witness. For such additional discovery, in no event shall a Party be permitted more than [**]. Within [**] days of the [**] within [**]) days thereafter and, [**]. The hearing shall be conducted on no more than [**] consecutive days and shall be governed by the following rules:

13.2.1. Each Party shall be entitled to [**] hours of hearing time to present its case. The Neutral shall determine whether each Party has had the [**] hours to which it is entitled.

13.2.2. Each Party shall be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony, documents, or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses shall occur immediately after their direct testimony, and cross-examination time shall be charged against the Party conducting the cross-examination.

13.2.3. The Party initiating the ADR shall begin the hearing and, if it chooses to make an opening statement, shall address therein not only issues it raised but also any issues raised by the responding Party. The responding Party, if it chooses to make an opening statement, also shall address all issues raised in the ADR. Thereafter, the presentation of regular and rebuttal testimony and documents, other evidence, and closing arguments shall proceed in the same sequence.

13.2.4. Except when testifying, witnesses shall be excluded from the hearing until closing arguments.

13.2.5. Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances. Affidavits prepared for purposes of the ADR hearing also shall not be admissible. As to all other matters, the Neutral shall have sole discretion regarding the admissibility of any evidence.

13.3. Prior to the completion of the hearing, a Party may seek leave from the Neutral to modify its proposed rulings on one or more issues to be resolved. If the Neutral finds good cause for such modification, within [**] days following completion of the hearing, the Parties shall file a substitute proposed ruling on each issue for which the Neutral allows a modification, together with a request for a specific damage award or other remedy for each such issue. The proposed ruling shall not contain any recitation of the facts or any legal arguments, and the proposed remedy shall not include any punitive damages. The proposed ruling and the proposed remedy collectively shall not exceed [**].

13.4. Within [**] days following completion of the hearing, each Party may submit to the other Party and the Neutral a post-hearing brief in support of its proposed rulings and remedies; provided , that such brief shall not contain or discuss any new evidence and shall not exceed [**]. This page limitation shall apply [**].

 

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13.5. The Neutral shall rule on each disputed issue within [**] days following completion of the hearing. Such ruling shall adopt in its entirety the proposed ruling and remedy of one (1) of the Parties on each disputed issue but may adopt one (1) Party’s proposed rulings and remedies on some issues and the other Party’s proposed rulings and remedies on other issues. The Neutral shall not issue any written opinion or otherwise explain the basis of the ruling.

13.6. The Neutral shall be paid a reasonable fee plus expenses. These fees and expenses, along with the reasonable legal fees and expenses of the prevailing Party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows:

13.6.1 If the Neutral rules in favor of one (1) Party on all disputed issues in the ADR, the losing Party shall pay [**] percent ([**]%) of such fees and expenses.

13.6.2 If the Neutral rules in favor of one (1) Party on some issues and the other Party on other issues, [**].

13.7. The rulings of the Neutral and the allocation of fees and expenses shall be binding, non-reviewable, and non-appealable, and may be entered as a final judgment in any court having jurisdiction.

13.8. Except as provided in Section 13.7 or as required by law, the existence of the Dispute, any settlement negotiations, the ADR proceeding, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed to be Confidential Information of both Parties. The Neutral shall have the authority to impose sanctions for unauthorized disclosure of Confidential Information.

13.9. Each Party shall have the right to be represented by counsel in all aspects of any ADR proceeding.

13.10. All proceedings and communications shall be in English.

13.11. Jury Waiver . EACH PARTY WAIVES ITS RIGHT TO TRIAL BY JURY OF ANY ISSUE WITHIN THE SCOPE OF THE AGREEMENT TO ARBITRATE AS SET FORTH IN SECTION 13.1.

13.12. Enforcement . The arbitrators’ award(s) shall be enforceable in any United States District Court of competent jurisdiction.

13.13. Expert Panel Arbitration .

13.13.1 . Any Dispute arising from the JSC and remaining unresolved after escalation to the Executive Officers pursuant to Section 2.9.2 and pertaining to [**].

13.13.2 . Any dispute to be resolved pursuant to this Section 13.13.2 will take place pursuant to the following procedures: Promptly following receipt of any notice requiring dispute resolution pursuant to this Section 13.13.2, the Parties shall meet and discuss in good faith and agree on an expert panel to resolve the issue, which expert panel shall be neutral and independent

 

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of both Parties and all of their respective Affiliates, shall have significant experience and expertise in the substantive area in question, and shall have some experience in mediating or arbitrating issues relating to such agreements. If the Parties cannot agree on such expert panel within [**] days of request by a Party for arbitration, then each Party shall select one (1) expert for such panel and the two (2) experts selected by the Parties shall select a third expert for the panel, provided , that all such three (3) experts must meet the foregoing criteria. Within [**] days after a panel is selected (or appointed, as the case may be), each Party will deliver to both the expert panel and the other Party a detailed written proposal setting forth its proposed terms for the resolution for the matter at issue (the “ Proposed Terms ” of the Party) and a memorandum (the “ Support Memorandum ”) in support thereof, not exceeding [**] pages in length. The Parties will also provide the expert panel a copy of this Agreement, as may be amended at such time. Within [**] days after receipt of the other Party’s Proposed Terms and Support Memorandum, each Party may submit to the expert panel (with a copy to the other Party) a response to the other Party’s Support Memorandum, such response not exceeding [**] pages in length. Neither Party may have any other communications (either written or oral) with the expert panel other than for the sole purpose of engaging the expert panel or as expressly permitted in this Section 13.13.2; provided , that the expert panel may convene a hearing if the expert panel so chooses to ask questions of the Parties and hear oral argument and discussion regarding each Party’s Proposed Terms. Within [**] days after the expert panel’s appointment, the expert panel will select one of the two Proposed Terms (without modification) provided by the Parties that the expert panel believes is most consistent with the intention underlying and agreed principles set forth in this Agreement. The decision of the expert panel shall be final, binding, and unappealable. The expert panel must select as the only method to resolve the matter at issue one of the two sets of Proposed Terms, and may not combine elements of both Proposed Terms or award any other relief or take any other action.

ARTICLE 14.

MISCELLANEOUS

14.1. Change of Control of the Parties .

14.1.1. Each Party (or its successor) shall provide the other Party with written notice of any Acquisition Transaction of such Party within [**] Business Days following the [**]; provided , that any failure to so provide such notice shall not be deemed a material breach of this Agreement.

14.2. Assignment; Successors .

14.2.1. This Agreement and the rights and obligations of each Party hereunder shall not be assignable, delegable, transferable, pledged or otherwise disposed of by either Party without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned, or delayed; provided , however , that (a) either Party may assign or transfer this Agreement, without such consent (but with written notice to the other Party), (i) to an Affiliate (but only for so long as such Person remains an Affiliate of such Party, it being agreed that such Party shall cause such assignment or transfer to terminate prior to such time, if any, as such Person ceases to be an Affiliate of such Party), or (ii) to a Third Party that acquires all or substantially all of the business or assets of such Party, whether by merger, reorganization, acquisition, sale or otherwise, including if such Party undergoes a Change of Control, and (b) this Section 14.2.1 shall not apply to

 

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sublicensing or subcontracting rights or obligations under this Agreement, which shall be conducted in accordance with this Agreement. If this Agreement is assigned or transferred to an Affiliate, the assigning or transferring Party shall remain responsible (jointly and severally) with such Affiliate for the performance of such assigned or transferred obligations. No assignment or transfer of this Agreement or a Party’s rights or obligations hereunder shall be valid and effective unless and until the assignee agrees in writing to be bound by the terms and conditions of this Agreement.

14.2.2. Notwithstanding anything to the contrary in ARTICLE 3 or in any other provision of this Agreement, the rights to compounds, products, materials and intellectual property (including Patent Rights and Know-How): (a) Controlled by a Third Party permitted assignee of a Party, which information, materials and intellectual property were Controlled by such assignee immediately prior to such assignment; or (b) Controlled by an Affiliate of a Party who becomes an Affiliate through any Acquisition Transaction by or of such Party, which compounds, products, materials and intellectual property were Controlled by such Affiliate immediately prior to such Acquisition Transaction or, or (c) in the case of (a) or (b) by such Third Party permitted assignee or Affiliate after such Third Party permitted assignee or Affiliate became such without reference to or use of any intellectual property rights of a Party, in each case ((a), (b) and (c)), shall be automatically excluded from the rights licensed or granted to the other Party under this Agreement.

14.2.3. Any permitted assignment of the rights and obligations of a Party under this Agreement shall be binding on, and inure to the benefit of and be enforceable by and against, the successors and permitted assigns of the assigning Party. The permitted assignee or transferee shall assume all obligations of its assignor or transferor under this Agreement. Without limiting the foregoing, the grant of rights set forth in this Agreement shall be binding upon any successor or permitted assignee of Infinity, and the obligations of AbbVie, including the payment obligations, shall run in favor of any such successor or permitted assignee of Infinity’s benefits under this Agreement. Any assignment or attempted assignment by either Party in violation of the terms of this Section 14.2.3 shall be null, void and of no legal effect.

14.3. Export Control . This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other governmental entity in accordance with applicable Law.

14.4. Choice of Law . This Agreement shall be governed by and interpreted under the laws of the State of Delaware, other than any principle of conflict or choice of laws that would cause the application of the laws of any other jurisdiction; provided , that all questions concerning (a) inventorship of Patents under this Agreement shall be determined in accordance with Section 8.1.3 and (b) the construction or effect of Patents shall be determined in accordance with the laws of the country or other jurisdiction in which the particular Patent has been filed or granted, as the case may be. The Parties agree to exclude the application to this Agreement of (a) the United Nations Conventions on Contracts for the International Sale of Goods; (b) the 1974 Convention on the Limitation Period in the International Sale of Goods (the “ 1974 Convention ”); and (c) the Protocol amending the 1974 Convention, done at Vienna April 11, 1980.

 

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14.5. Notices . Any notice or report required or permitted to be given or made under this Agreement by one Party to the other shall be in writing and shall be deemed to have been delivered (a) upon personal delivery, (b) on the second Business Day (at the place of delivery) next following deposit with a reputable, internationally recognized overnight courier that maintains records of delivery and (c) in the case of notices provided by telecopy (which notice shall be followed immediately by an additional notice pursuant to clause (b) or (c) above if the notice is of a default hereunder), upon completion of transmission, with transmission confirmed, to the addressee’s facsimile machine, as follows (or at such other addresses or facsimile numbers as may have been furnished in writing by a Party to the other as provided in this Section 14.5). This Section 14.5 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement.

 

If to Infinity:    Infinity Pharmaceuticals, Inc.
   780 Memorial Drive
   Cambridge, Massachusetts 02139
   Attn : Chief Executive Officer
   Fax: 1-617-453-1001
With a copy to:    Infinity Pharmaceuticals, Inc.
   780 Memorial Drive
   Cambridge, Massachusetts 02139
   Attn : General Counsel
   Fax: 1-617-453-1001
If to AbbVie:   

AbbVie Inc.

1 North Waukegan Road

North Chicago, Illinois 60064

Attn : Executive Vice President, Business

Development, External Affairs and General Counsel

Fax: 1-847- 935-3294

With a copy to:   

Ropes & Gray LLP

800 Boylston Street

Prudential Tower

Boston, Massachusetts 02199-3600

Attn : Marc Rubenstein

Fax: 1-617-235-0706

14.6. Severability . If, under applicable Law, any provision of this Agreement is invalid or unenforceable, or otherwise directly or indirectly affects the validity of any other material provision of this Agreement and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (such invalid or unenforceable provision, a “ Severed Clause ”), it is mutually agreed that (a) this Agreement shall endure except for the Severed Clause, (b) this Agreement shall be construed and enforced as if such Severed Clause had

 

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never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the Severed Clause or by its severance herefrom, and (d) in lieu of such illegal, invalid, or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid, and enforceable provision as similar in terms to such illegal, invalid, or unenforceable provision as may be possible and reasonably acceptable to the Parties. To the fullest extent permitted by applicable Law, each Party hereby waives any provision of law that would render any provision hereof illegal, invalid, or unenforceable in any respect.

14.7. Integration . This Agreement (and, when executed, each Related Agreement), together with all schedules and exhibits attached hereto, constitutes the entire agreement between the Parties with respect to the subject matter of this Agreement and supersedes all previous agreements, whether written or oral, including the Prior CDA. In the event of a conflict between the GDP, any Commercialization Plan or any schedules or attachments to this Agreement, on the one hand, and this Agreement, on the other hand, the terms of this Agreement shall govern. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement.

14.8. English Language . This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.

14.9. Waivers and Amendments . The failure of any Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party. Notwithstanding the authority granted to any Committee or Working Group under this Agreement, (a) no waiver shall be effective unless it has been given in writing and signed by the Party giving such waiver, and (b) no provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives of each Party.

14.10. Independent Contractors; No Agency . Neither Party shall have any responsibility for the hiring, firing or compensation of the other Party’s or such other Party’s Affiliates’ employees or for any employee benefits with respect thereto. No employee or representative of a Party or its Affiliates shall have any authority to bind or obligate the other Party for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on such other Party, without such other Party’s written approval. For all purposes, and notwithstanding any other provision of this Agreement to the contrary, each Party’s legal relationship under this Agreement to the other Party shall be that of independent contractor, and the relationship between the two (2) Parties shall not constitute a partnership, joint venture, or agency, including for all tax purposes.

14.11. Execution in Counterparts; Facsimile Signatures . This Agreement may be executed in counterparts, each of which counterparts, when so executed and delivered, shall be deemed to be an original, and all of which counterparts, taken together, shall constitute one and the same instrument even if both Parties have not executed the same counterpart. Signatures provided by facsimile transmission or in Adobe™ Portable Document Format (PDF) sent by electronic mail shall be deemed to be original signatures.

 

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14.12. No Consequential or Punitive Damages .

14.12.1. EXCEPT AS SET FORTH IN SECTION 14.12.2, NEITHER PARTY NOR ANY OF ITS AFFILIATES WILL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE OR MULTIPLE DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, OR FOR ANY LOSS OR INJURY TO A PARTY’S OR ITS AFFILIATES’ PROFITS, BUSINESS (INCLUDING BUSINESS INTERRUPTION) OR GOODWILL ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, IN EACH CASE HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES.

14.12.2. THE LIMITATIONS AND DISCLAIMER SET FORTH IN SECTION 14.12.1 SHALL NOT APPLY TO A CLAIM (I) FOR WILLFUL MISCONDUCT; (II) BY INFINITY AGAINST ABBVIE FOR DAMAGES RESULTING FROM A BREACH OF SECTION 3.7.2; (III) BY ABBVIE AGAINST INFINITY FOR DAMAGES RESULTING FROM AN INTENTIONAL AND WILLFUL BREACH OF SECTIONS 3.7.1; OR (IV) FOR DAMAGES RESULTING FROM A BREACH OF ARTICLE 9.

14.12.3. NOTHING IN THIS SECTION 14.12 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY WITH RESPECT TO THIRD PARTY CLAIMS.

14.13. Performance by Affiliates . To the extent that this Agreement imposes obligations on Affiliates or Sublicensees of a Party, such Party shall cause its Affiliates and shall use Diligent Efforts to cause its Sublicensees to perform such obligations. Either Party may use one or more of its Affiliates to perform its obligations and duties hereunder; provided , that each such Affiliate or Sublicensee shall be bound by the corresponding obligations of the applicable Party and provided , further , that, subject to such Party’s assignment to an Affiliate pursuant to Section 14.2, such Party shall remain liable hereunder for the prompt payment and performance of all of its obligations hereunder.

14.14. Force Majeure . Neither Party shall be responsible to the other for, or be deemed to have defaulted under or breached this Agreement for, any failure or delay in performing any of its obligations under this Agreement or for other nonperformance hereunder (excluding, in each case, the obligation to make payments when due) if such delay or nonperformance is caused by or results from events beyond the reasonable control of the non-performing Party, including strike, fire, flood, earthquake, hurricanes, accident, war, acts of war (whether war be declared or not), insurrections, riots, civil commotion, strikes, lockouts, or other labor disturbances (whether involving the workforce of the non-performing Party or of any other Person), act of terrorism, act of God or acts, omissions or delays in acting of the government of any country or of any local government, or by cause unavoidable or beyond the reasonable control of such Party (except to the extent such delay results from the breach by the non-performing Party or any of its Affiliates of

 

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any term or condition of this Agreement). In such event, the Party affected will promptly (and, in any event, within thirty (30) days) notify the other Party in writing of such force majeure event, stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party and shall use Diligent Efforts to resume performance of its obligations.

14.15. No Third Party Beneficiary Rights . This Agreement is not intended to and shall not be construed to give any Third Party any interest or rights (including any third party beneficiary rights) with respect to or in connection with any agreement or provision contained herein or contemplated hereby, other than, to the extent provided in ARTICLE 11, the Indemnified Parties (including Persons entitled to indemnification under ARTICLE 11 with respect to Product Liability Actions).

14.16. Non-exclusive Remedy . Except as expressly provided herein, the rights and remedies provided herein are cumulative and each Party retains all remedies at law or in equity, including the Parties’ ability to receive legal damages or equitable relief, with respect to any breach of this Agreement. Neither Party shall be required to terminate this Agreement due to a breach of this Agreement by the other Party.

14.17. Interpretation . The Article and Section headings used herein are for reference and convenience only, and will not enter into the interpretation of this Agreement. Except as otherwise explicitly specified to the contrary, (a) references to an Article, Section, Exhibit or Schedule means an Article or Section of, or a Schedule or Exhibit to this Agreement and all subsections thereof, unless another agreement is specified; (b) references in any Section to any clause are references to such clause of such Section; (c) references to any agreement, instrument, or other document in this Agreement refer to such agreement, instrument, or other document as originally executed or, if subsequently amended, replaced, or supplemented from time to time, as so amended, replaced, or supplemented and in effect at the relevant time of reference thereto; (d) references to a particular Law mean such Law as in effect as of the relevant time, including all rules and regulations thereunder and any successor Law in effect as of the relevant time, and including the then-current amendments thereto; (e) words in the singular or plural form include the plural and singular form, respectively; (f) unless the context requires a different interpretation, the word “or” has the inclusive meaning that is typically associated with the phrase “and/or”; (g) the terms “including,” “include(s),” “such as,” “e.g.” and “for example” mean including the generality of any description preceding such term and will be deemed to be followed by “without limitation”; (h) whenever this Agreement refers to a number of days, such number will refer to calendar days unless Business Days are specified, and if a period of time is specified and dates from a given day or Business Day, or the day or Business Day of an act or event, it is to be calculated exclusive of that day or Business Day; (i) “monthly” means on a calendar month basis, (j) “quarter” or “quarterly” means on a Calendar Quarter basis; (k) “annual” or “annually” means on a Calendar Year basis; (l) “year” means a three hundred sixty-five (365) day period unless Calendar Year is specified; (m) “$” or “dollars” means U.S. Dollars; (n) references to a particular Person include such Person’s successors and assigns to the extent not prohibited by this Agreement; (o) all words used in this Agreement will be construed to be of such gender or number as the circumstances require; (p) a capitalized term not defined herein but reflecting a different part of speech than a capitalized term which is defined herein shall be interpreted in a correlative manner; (q) any definition of or

 

114


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); (r) the words “hereof,” “herein,” “hereby” and derivative or similar words refer to this Agreement (including any Exhibits or Schedules); (s) neither Party or its Affiliates shall be deemed to be acting “on behalf of” the other Party hereunder, except to the extent expressly otherwise provided; (t) there shall be no double-counting in calculating Development Costs or Net Profit or Loss or any components thereof; and (u) provisions that require that a Party, the Parties or any Committee or Working Group hereunder “agree”, “consent” or “approve” or the like shall be deemed to require that such agreement, consent or approval be specific and in writing in a written agreement, letter or approved minutes, but, except as expressly provided herein, excluding e-mail and instant messaging).

14.18. Further Assurances .

14.18.1. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.

14.18.2. If, during the Term, either Party determines that a filing or notification under any applicable antitrust law, including the HSR Act, is necessary or advisable at a date after the Execution Date during the Term, then such Party shall indicate the same by providing notice to the other Party as promptly as practicable (but in any event within ten (10) business days). The costs and expenses associated with such notifications and filings shall be considered Allowable Expenses in accordance with Exhibit A. Each Party shall use its commercially reasonable efforts to obtain the expiration or termination of the applicable waiting period under the HSR Act, and to obtain the termination or expiration of any other applicable waiting periods or any necessary approvals or consents under any other applicable antitrust law, at the earliest possible date after the date of filing.

14.19. Ambiguities; No Presumption . Each of the Parties acknowledges and agrees that this Agreement has been diligently reviewed by and negotiated by and between them, that in such negotiations each of them has been represented by competent counsel and that the final agreement contained herein, including the language whereby it has been expressed, represents the joint efforts of the Parties hereto 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.

14.20. Records Generally . Without limiting any of the Party’s obligations set forth in any other provision of this Agreement or the Related Agreements, each Party shall keep or cause its Affiliates to keep records as are appropriate to document such Party’s, and its Affiliates’, compliance with its obligations hereunder, under the Related Agreements, and under applicable Law, pertaining to Manufacturing, quality control and quality assurance matters, and Development (including clinical activities), in a manner consistent with this Agreement and each applicable Related Agreement for those periods applicable to such records in accordance with applicable Laws and each applicable Related Agreement.

[Remainder of this page intentionally blank.]

 

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IN WITNESS WHEREOF, each Party has caused this Agreement to be duly executed by its authorized representative under seal, in duplicate on the Execution Date.

 

INFINITY PHARMACEUTICALS, INC.

/s/ Adelene Q. Perkins

Name: Adelene Q. Perkins
Title: President and Chief Executive Officer
ABBVIE INC.

/s/ William J. Chase

Name: William J. Chase
Title: Executive Vice President, Chief Financial Officer

 

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SCHEDULE 1.40

EXCLUSIVITY COMPOUNDS

For a given small molecule compound, such compound meets the PI3K selectivity criteria as described below:

[**]

[**] see Schedule A).


SCHEDULE A

[**] DESCRIPTION

[**]


SCHEDULE 3.5.1

NON-ROYALTY PAYMENTS UNDER EXISTING INFINITY THIRD PARTY

AGREEMENTS

Milestone Events and Milestone Payments

Capitalized words used in this Schedule 3.5.1 have the meaning given to them in the

Intellikine Agreement.

Infinity will pay to Intellikine the Milestone Payments shown below within [**] days after Infinity becomes aware of achievement of such Milestone Event (or in the case of the achievement of Milestone Event in row 3, Column 3, upon the Effective Date).

For purposes of clarity:

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of two pages were omitted. [**]


No.

  

Milestone Event

   Column C:
Milestone Payment
upon achievement by
the first Licensed
Compound or
Product to have
achieved the
Milestone Event in
the relevant row
(US$)
     Column D:
Milestone Payment
upon achievement by
the next Licensed
Compound or Product
to have achieved the
Milestone Event in the
relevant row, other
than the Licensed
Product which
achieved the Milestone
Event in such row in
Column C (US$)
1.    Initiation of the first IND-enabling cGLP toxicology study for a Licensed Compound (other than INK1197)     

 

$1,000,000

PAID

  

  

   N/A
2.    First Patient, First Visit in a Phase I Study     

 

$3,000,000

PAID

  

  

   $1,000,000

PAID

3.    First Patient, First Visit in a Phase II Study     

 

$5,000,000

PAID

  

  

   [**]
4.    First Patient, First Visit in a Phase III Study     

 

$10,000,000

PAID

  

  

   [**]
5.    [**]      [**]       [**]
6.    [**]      [**]       [**]
7.    [**]      [**]       [**]
8.    [**]      [**]       [**]
9.    [**]      [**]       [**]
10.    [**]      [**]       [**]
11.    [**]      [**]       [**]
12.    [**]      [**]       [**]
13.    [**]      [**]       [**]
14.    [**]      [**]       [**]
15.    [**]      [**]       [**]
16.    [**]      [**]       [**]
17.    [**]      [**]       [**]
18.    [**]      [**]       [**]
19.    [**]      [**]       [**]

TOTAL ALL MILESTONES:

     U.S.$475,000,000      

 


SCHEDULE 4.6.1

PRE-EXECUTION DATE DEVELOPMENT COSTS

 

     Estimated Amount ($)  

[**]

     [**]   

[**]

     [**]   

[**]

     [**]   

Total

     [**]   


SCHEDULE 7

FINANCIAL TERMS

7.1 Upfront and Milestone Payments .

7.1.1 Upfront Payment . In partial consideration of the rights granted to AbbVie under this Agreement, AbbVie shall make a non-refundable, non-creditable payment of Two-Hundred Seventy-Five Million Dollars (US $275,000,000) to Infinity within forty-five (45) days after the Effective Date.

7.1.2 Milestone Payments . AbbVie would pay Infinity the following one-time milestone payments (each, a “ Milestone Payment”) within [**] days after first achieving each of the following milestones in the relevant jurisdiction (each, a “ Milestone Event ”):

 

Milestone Event    [**]    [**]
[**]    [**]   
[**]    [**]    [**]
[**]    [**]    [**]
[**]    [**]    [**]


For purposes of this Section 7.1.2, [**].

Each milestone payment would be payable only upon first achievement, and no amounts would be due for subsequent or repeated achievements, whether for the same or different Product. For clarity, the Milestone Payment payable on the [**].

7.1.3 Milestone Event Notice . Within [**] Business Days after a Party becomes aware that a Milestone Event was achieved, it shall notify the other Party thereof in writing.


SCHEDULE 10.2.7

LITIGATION

[**].


EXHIBIT A

FINANCIAL EXHIBIT

Net Profit or Loss ” in the United States shall be calculated in accordance with this Exhibit A . Net Profit or Loss shall exclude all of the payments set forth in Section 7.1, all Development Costs and capital expenditures, and any other cost not specifically included in Allowable Expenses, including costs attributable to general corporate activities, executive management, investor relations, treasury services, business development, corporate government relations, external financial reporting and other overhead activities. For the sake of clarity, cost items included in components of Net Profit or Loss shall not be double counted and shall not be included in Development Costs.

Calculation of Net Profit or Loss

Net Profit or Loss in the United States shall be calculated for each Calendar Quarter by determining the Net Sales of Products in the United States, adding any other income and subtracting the sum of the Allowable Expenses (in each case, to the extent not already deducted from Net Sales and with respect to the Products in the United States) incurred with regard to Products in the United States during such Calendar Quarter. Notwithstanding the foregoing, on a Calendar Year-to-date basis, Allowable Expenses shall not be included in such calculation if such expenses are in excess of the amounts allocated for such Calendar Year-to-date period in the US Commercialization Budget and each Party will be solely responsible for Allowable Expenses it incurs in excess of the amounts set forth in the US Commercialization Budget; provided , however , that Allowable Expenses in excess of the US Commercialization Budget shall be included in the calculation of Net Profit or Loss (i) if the JSC approves such excess Allowable Expenses (either before or after they are incurred), which approval shall not be unreasonably withheld to the extent the Allowable Expenses in excess of the US Commercialization Budget were not within the reasonable control of the Party (or Party’s Affiliate) incurring such expense; (ii) to the extent such excess does not exceed by more than ten percent (10%) of the total Allowable Expenses allocated to be incurred by such Party and its Affiliates in the applicable Calendar Year-to-date period in accordance with the US Commercialization Budget for such Calendar Year; provided , however , that if any such excess Allowable Expenses are excluded from sharing by the Parties for a particular Calendar Year-to-date period pursuant to the foregoing clause, such excess Allowable Expenses shall be carried forward to subsequent Calendar Quarters ( provided , that such Calendar Quarters fall within the same Calendar Year); or (iii) if such Allowable Expense is a Shared Product Liability Cost which were not anticipated at the time the US Commercialization Budget was established for a Calendar Year, in which case such Shared Product Liability Costs shall not be included for determining whether the Parties have exceeded the amounts budgeted to be incurred by such Parties in such Calendar Year for Allowable Expenses.


Definitions

The following definitions shall apply for purposes of calculating pre- and post-Commercialization Net Profit or Loss in accordance with this Exhibit A .

(1) “ Allowable Expenses ” means, subject to the other provisions of this Agreement and any US Commercialization Plan hereunder, the sum of the following costs and expenses incurred following the Effective Date by the Parties or their Affiliates, in the course of the Commercialization of the Products in the US Territory in accordance with this Agreement during the applicable Calendar Quarter or the applicable Calendar Year, in each case that are incurred in accordance with the US Commercialization Budget (each as defined in the section listed in parentheses below):

 

  a. Blocking Third Party Intellectual Property Costs (Section 1.12);

 

  b. Distribution Costs (Exhibit A, Section (4));

 

  c. EAP Expenses (Exhibit A, Section (5));

 

  d. Infinity Third Party Agreement Payments (Section 1.83);

 

  e. Health Care Reform Fees (Exhibit A, Section (6));

 

  f. Marketing Expenses (Exhibit A, Section (7));

 

  g. Other Commercialization Costs (Exhibit A, Section (9));

 

  h. Product Trademark Costs (Section 8.7.2(c)(iii));

 

  i. Recall Expenses (Exhibit A, Section (11));

 

  j. Regulatory Maintenance Costs (Exhibit A, Section (12));

 

  k. Selling Expenses (Exhibit A, Section (8));

 

  l. [**];

 

  m. [**]

 

  n. Shared Product Liability Costs (Section 11.4.3);

 

  o. Alliance Manager Expenses ((Exhibit A, Section (2)); and

 

  p. Supply Price of Products for Commercialization (Exhibit A, Section (13)).

For clarity, it is understood that Allowable Expenses shall include only Out-of-Pocket Costs and Commercial FTE Costs, and shall exclude Development Costs, and that internal costs of a Party and its Affiliates shall be reimbursed only as reflected in Commercial FTE


Costs. Notwithstanding anything to the contrary in this Exhibit A , to the extent that any activity is conducted (or an Out-of-Pocket Cost or Commercial FTE Cost is incurred) in support of both a Product and other products, services or efforts of a Party, or are not solely attributable to a Product, or are not solely attributable to the US Territory, then the Out-of-Pocket Costs and Commercial FTE Costs thereof shall be included in Allowable Expenses only to the extent included in the US Commercialization Budget, or expressly and specifically included under this Financial Exhibit. In connection with the JCC’s review of a proposed US Commercialization Budget, upon the request of either Party, the JCC shall review the methodology used to allocate to the Allowable Expenses, the Commercial FTE Costs and Out-of-Pocket Costs of such combined activity, and if the JCC does not approve such methodology, the matter shall be resolved by the JSC.

(2) “ Alliance Manager Expenses ” means the Commercial FTE Costs for the Alliance Manager and the Out-of-Pocket Costs incurred by the Alliance Manager in performing his/her responsibilities in accordance with this Agreement, to the extent such expenses are allocated to the US Territory by the JCC.

(3) “ Commercial FTE Costs ”, which equals the relevant Commercial FTEs times the appropriate FTE Rate, where

(a) “ Commercial FTEs ” means personnel engaged full time for one (1) Calendar Year (consisting of at least a total of [**] hours per Calendar Year) in performing Commercialization activities under the US Commercialization Plan. No additional payment shall be made with respect to any person who works more than [**] hours per Calendar Year and any person who devotes less than [**] hours per Calendar Year (or such other number as may be agreed by the JCC or JSC, as applicable) shall be treated as a Commercial FTE on a pro rata basis based upon the actual number of hours worked divided by [**]; provided that such person devotes a minimum of [**] hours per Calendar Year to performing Commercialization activities under the US Commercialization Plan.

(4) “ Distribution Costs ” means a fixed percent of Net Sales in the US Territory, such percent to be determined by the JCC with input and support from the Finance Working Group, which amount shall be deemed to have been incurred as Allowable Expenses by the Parties. It is understood that such amount shall be deemed to cover all Out-of-Pocket Costs and Commercial FTE Costs specifically identifiable or reasonably allocable to the distribution of Products, including customer and wholesaler services, order entry, billing, shipping, logistics, warehousing, product insurance, freight not paid by customers, credit and collection and other like activities the costs of which are includable in “Distribution Costs” in accordance with the applicable Accounting Standards, consistently applied, which shall not otherwise be included in Allowable Expenses. For clarity, “Distribution Costs” shall not include costs of activities included within Marketing Expenses or Selling Expenses.

(5) “ EAP Expenses ” means the Out-of-Pocket Costs and Development FTE Costs or Medical Affairs FTE Costs to conduct Early Access Programs for the Product in accordance with this Agreement.


(6) “ Health Care Reform Fees ” means Out-of-Pocket Costs representing the annual fee paid to the U.S. government as defined in the ACA and similar taxes and governmental fees in the United States, in each case to the extent directly attributable to the Product.

(7) “ Marketing Expenses ” means Out-of-Pocket Costs and Commercial FTE Costs identifiable to the advertising, promotion and marketing of a Product in the Field in the US Territory, and related professional education, in each case to the extent incurred specifically with respect to a Product (and to the extent not performed by Sales Representatives) in the US Territory, including:

a. Advertising, which includes Out-of-Pocket Costs and Commercial FTE Costs associated with media costs, direct mails, production expenses, agency fees, and medical congresses and meetings and other advertising activities;

b. Promotion, which includes Out-of-Pocket Costs and Commercial FTE Costs associated with professional samples, reimbursement of patient assistance programs, public relations and communications expenses, development of information and data for national accounts, managed care organizations and group purchasing organizations and other promotional activities;

c. Market Research, which includes Out-of-Pocket Costs and Commercial FTE Costs associated with market information, focus groups, and market research professional staff and related Out-of-Pocket Costs such as travel, business meals;

d. Marketing Management, which includes the Out-of-Pocket Costs and Commercial FTE Costs of product management, to the extent directly performing activities with respect to the marketing and brand strategy development of Products;

e. Reimbursement/Access Services, which includes Out-of-Pocket Costs incurred to manage marketing programs, marketing costs (educational material) as well as coupon or co-pay programs directly attributable to a Product; provided , however , that, if employees of Infinity or AbbVie or any of their respective Affiliates provide this service, then the Commercial FTE Costs of such employees and the related Out-of-Pocket Costs such as travel, business meals, and entertainment will be included;

f. Health Policy/Advocacy, which includes Out-Of-Pocket Costs reasonably necessary and identifiable to a Product, such as advocacy sponsorships for the Product’s specific disease state as well as any specific policy lobbying and trade and government relations related expenses, in each case to the extent attributable to and specifically conducted with respect to such Product;

g. Activities involving key opinion leaders;

h. Launch meetings;


i. Conducting advisory board meetings or other consultant programs, the purpose of which is to obtain advice and feedback related to the Commercialization of a Product; and

j. Web site (product or disease state) development, implementation and fees.

(8) “ Selling Expenses ” includes Out-of-Pocket Costs and Commercial FTE Costs reasonably necessary and identifiable to the Product incurred with respect to: sales representatives, sales managers, sales deployment planning, customer targeting, payor and reimbursement activities, and hospital and managed health care activities. The Sales Representative FTEs and Sales Manager FTEs are calculated as described in the definitions thereof. All other Selling Expense FTE Costs are as described in this Exhibit A , Section (3). Costs for performance reporting and Sales Force Automation (SFA) tools and hardware, such as laptops or tablets used to track activity, are not billable costs under this Agreement unless shared systems are developed and mutually agreed as a billable cost.

(9) “ Other Commercialization Costs ” means any Out-of-Pocket Costs and Commercial FTE Costs approved by the JCC and included in the US Commercialization Plan and the US Commercialization Budget that is not otherwise included in any other Allowable Expense category. It is understood that Other Commercialization Costs shall not include costs associated with Development activities.

(10) “ Other Income ” means any payment or income (other than Net Sales) received by a Party (or its Affiliate) from the other Party (or its Affiliate) or a Third Party that is attributable to a Product or is received in connection with the grant of a sublicense or other right or activity with respect to the Products.

(11) “ Recall Expenses ” means Out-of-Pocket Costs and Commercial FTE Costs directly associated with notification, retrieval and return of a Product, destruction of such returned Product, replacement Product and distribution of the replacement Product, in each case that are incurred with respect to a Recall conducted in accordance with Section 5.1.2 of the Agreement; the Parties acknowledge that if the Recall was not anticipated at the time the US Commercialization Budget was established for a Calendar Year, then the Recall Expenses shall not be included for determining whether the Party conducting such Recall has exceeded the amounts budgeted to be incurred by such Party in such Calendar Year for Allowable Expenses. Notwithstanding the foregoing, for clarity, Recall Expenses that are Losses entitled to indemnification under Sections 11.1(b) or 11.2(b) shall be solely borne by the relevant Indemnifying Party, and shall not be shared hereunder.

(12) “ Regulatory Maintenance Costs ” means Out-of-Pocket Costs and Commercial FTE Costs for maintenance fees relating to Marketing Authorizations for the Products in the Field in the US, and personnel engaged in the filing and maintenance of Marketing Authorizations in the US.


(13) “ Supply Price ” means, with respect to a Product, the Manufacturing cost for such Product, which (a) to the extent such Product is Manufactured by a Party or its Affiliates, shall approximate a reasonable definition of cost of goods sold for such Product with no markup, assuming full utilization of Manufacturing capacity, and (b) to the extent such Product is Manufactured by a Third Party in an arms-length transaction, the Out-of-Pocket Costs paid to such Third Party for the Manufacture of such Product.

General Principles .

Allowable Expenses shall initially be borne by the Party incurring the cost or expense, subject to reimbursement as provided herein.

Each Party shall provide financial statements in such reporting format as the Finance Working Group may establish for use by the Parties.

All calculations to be made pursuant to this Financial Exhibit shall be made in accordance with (i) the applicable definitions and terms set forth in this Financial Exhibit and in the Agreement in a manner consistent with the methodologies used for the US Commercialization Budgets (first priority), (ii) the specific accounting policies as may be established by the Finance Working Group (second priority) and (iii) applicable Accounting Standards, consistently applied (third priority). All undefined terms shall be construed in accordance with applicable Accounting Standards, consistently applied, but only to the extent consistent with the other express terms and definitions in this Financial Exhibit and the Agreement and specific accounting policies established by the Finance Working Group.

For clarity, income and withholding taxes imposed on either of the Parties or their Affiliates hereunder will not be included in the calculation of Net Profit or Loss.

Losses from Third Party Claims; Exclusion of Costs Due to Breach or Subject to Indemnification under Section 11.1 or 11.2

The Parties agree that Losses that arise out of the performance, in good faith, of Development, Manufacture, Commercialization or other exploitation of Products in or for the United States following the Effective Date in accordance with the Agreement (“ Collaboration Losses ”) will be charged to the Net Profit or Loss; provided , that Net Profit or Loss will not include Losses or costs of a Party or its Affiliate that are: (i) caused by a breach of this Agreement by such Party or Affiliate; or (ii) subject to indemnification by such Party pursuant to Section 11.1 or Section 11.2 (except for Product Liability Costs, which will be treated in accordance with Section 11.4 as set forth therein) (and for clarity, if a Third Party makes a Third Party Claim (other than a Product Liability Action for which the costs are shared as Shared Product Liability Costs) directly against Infinity (or any of its Affiliates) or AbbVie (or any of its Affiliates), respectively, that would otherwise be indemnified by Infinity or AbbVie, respectively, if such Third Party Claim had been made against the other Party (or any of its Affiliates), then Losses incurred by Infinity or AbbVie in connection with such direct Third Party Claim will not be included in the calculation of Net Profit or Loss).


Reconciliations

The Finance Working Group will coordinate to resolve any differences in or disputes regarding the calculation of Net Profit or Loss, or any component thereof. If the Finance Working Group is unable to resolve any such difference or dispute, the matter shall be resolved by the JSC.


EXHIBIT B-1

OWNED INFINITY PATENT RIGHTS

 

Title

   Country    Application
Number
   Publication
Number
   Patent Number    Filing
Date

[**]

   [**]    [**]          [**]

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of three pages were omitted. [**]


EXHIBIT B-2

IN-LICENSED INFINITY PATENT RIGHTS

 

Title

   Country    Application
Number
   Publication
Number
   Patent Number    Filing
Date

[**]

   [**]    [**]          [**]

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of three pages were omitted. [**]


EXHIBIT C

GLOBAL DEVELOPMENT PLAN

1. Initial Global Development Plan

[**]

2. IPI-145 Clinical Study Details

 

[**]
Objective    The goal of this study is to [**].
Study Design    This study consists of [**].
Dosing Arms   

The dose expansion cohorts are:

[**]

Patient Population    [**]
Endpoints   
Estimated Enrollment    [**]
Notes    [**]
[**]   
Objective    To evaluate the [**].
Study Design    [**]
Dosing Arms    [**]
Patient Population    [**]
Endpoints    [**]
Estimated Enrollment    [**]
Notes    [**]
[**]   
Objective    To evaluate the [**]
Study Design    [**]
Dosing Arms    [**]
Patient Population    [**]
Endpoints    [**]
Estimated Enrollment    [**]


[**]   
Objective    To evaluate the [**]
Study Design    [**]
Dosing Arms    [**]
Patient Population    [**]
Endpoints    [**]
Estimated Enrollment    [**]
[**]   
Objective    To evaluate the [**]
Study Design    [**]
Dosing Arms    [**]
Patient Population    [**]
Endpoints    [**]
Estimated    [**]
[**]   
Objective    To characterize [**].
Study Design    [**]
Dosing Arms    [**]
Patient Population    [**]
Endpoints    [**]
Estimated Enrollment    [**]
Notes    [**]


[**]   
Objective    To evaluate the [**].
Study Design    [**]
Dosing Arms    [**]
Patient Population    [**]
Endpoints    [**]
Estimated Enrollment    [**]
Notes    [**]
[**]   
Objective    [**]
Study Design    [**]
Dosing Arms   
Patient Population    [**]
Endpoints    [**]
Estimated Enrollment    [**]
[**]   
Objective    To establish [**].
Study Design    [**]
Dosing Arms    [**]
Patient Population    [**]
Endpoints    [**]
Estimated Enrollment    [**]
[**]   
Objective    To evaluate the [**].
Study Design    [**]
Dosing Arms    [**]
Patient Population    [**]
Endpoints    [**]
Estimated Enrollment    [**]
Notes    [**]


[**]   
Objective    To study [**].
Study Design    [**]
Dosing Arms    [**]
Patient Population    [**]
Endpoints    [**]
Estimated Enrollment    [**]
Notes    [**]
[**]   
Objective    To establish [**].
Study Design    [**]
Dosing Arms    [**]
Patient Population    [**]
Endpoints    [**]
Estimated Enrollment    [**]


[**]   
Objective    To evaluate the [**].
Study Design    [**]
Dosing Arms    [**]
Patient Population    [**]
Endpoints    [**]
Estimated Enrollment    [**]
Notes    [**]
[**]   
Objective    To enable [**].
Study Design    [**]
Dosing Arms    [**]
Patient Population    [**]
Endpoints    [**]
Estimated Enrollment    [**]
Notes    [**]
[**]   
Objective    To study the [**].
Study Design    [**]
Dosing Arms   
Patient Population    [**]
Endpoints    [**]
Estimated Enrollment    [**]
Notes    [**]


3. Budget for Infinity Conducted Studies and Activities in Initial Global Development Plan (GDP) Excluding AbbVie Conducted and Investigator Sponsored Studies and Activities

[**]

4. Budget for AbbVie Conducted Studies and Activities in Initial Development Plan (GDP) Excluding Infinity Conducted and Investigator Sponsored Studies and Activities

[**]

5. IPI-145 CMC Activity Plan

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of three pages were omitted.

[**]

6. Budget for IPI-145 CMC Activity Plan

[**]


EXHIBIT D

IPI-145

 

LOGO


EXHIBIT E

PRESS RELEASE

 

 

LOGO

FOR RELEASE ON WEDNESDAY, SEPTEMBER 3, 2014, AT 6:45 A.M. ET

Contacts:

Infinity Pharmaceuticals, Inc.

Jaren Irene Madden, 617-453-1336

Jaren.Madden@infi.com

http://www.infi.com

AbbVie

Adelle Infante, 847-938-8745

adelle.infante@abbvie.com

http://www.abbvie.com

INFINITY AND ABBVIE ANNOUNCE GLOBAL STRATEGIC

COLLABORATION TO DEVELOP AND COMMERCIALIZE DUVELISIB

(IPI-145) IN ONCOLOGY

– Infinity to Receive $275 Million Up-Front Payment and $530 Million in Potential

Milestones –

– Companies to Jointly Develop and Commercialize Duvelisib in U.S., with Equal Profit

Share; Infinity to Receive Royalties on Sales Outside the U.S. –

– Infinity to Host Conference Call Today at 8:30 A.M. ET/7:30 A.M. CT –

Cambridge, MA and North Chicago, Ill – September 3, 2014 – Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) and AbbVie Inc. (NYSE: ABBV) today announced that they have entered into a global collaboration to develop and commercialize duvelisib (IPI-145), Infinity’s oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, for the treatment of patients with cancer. Duvelisib has shown clinical activity across a broad range of blood cancers, including indolent non-Hodgkin lymphoma (iNHL) and chronic lymphocytic leukemia (CLL). Infinity is conducting registration-focused trials evaluating the safety and efficacy of duvelisib, including DYNAMO TM , a Phase 2 study in patients with iNHL, and DUO TM , a Phase 3 study in patients with CLL.


Under the terms of the agreement, Infinity will receive an upfront payment of $275 million and is eligible to receive up to $530 million in additional payments for the achievement of development, regulatory and commercial milestones, including up to $405 million for the achievement of milestones through the first commercial sale of duvelisib. In the U.S., the companies will jointly commercialize duvelisib and will share equally in any potential profits. Outside the U.S., AbbVie will be responsible for the conduct and funding of commercialization of duvelisib, and Infinity is eligible to receive tiered double-digit royalties on net product sales.

“We believe that duvelisib is a very promising investigational treatment based on clinical data showing activity in a broad range of blood cancers,” said Michael Severino, M.D., AbbVie executive vice president and chief scientific officer. “The addition of duvelisib will complement AbbVie’s emerging oncology pipeline and expand our research into combination therapies to generate improved outcomes for cancer patients. We look forward to working with Infinity to bring duvelisib to patients worldwide.”

“This collaboration is an important step toward fulfilling Infinity’s objective of bringing better treatments to patients and further advances our goal of building a sustainable, fully integrated biotechnology company,” stated Adelene Q. Perkins, chair, president and chief executive officer at Infinity. “AbbVie will be a wonderful partner for Infinity, bringing all of the expertise and scale of a successful, well established company, together with the energy, drive, innovation, and nimbleness of a young organization. We look forward to advancing duvelisib through monotherapy studies designed to enable registration and in furthering our shared longer-term vision of combining duvelisib with both current standards of care and novel, targeted therapies.”

Additional Details About the Collaboration

Development and commercialization activities under the collaboration will be managed through a shared governance structure. In the U.S., Infinity and AbbVie will jointly commercialize duvelisib, assuming regulatory approval, with Infinity booking sales, and will share equally in any potential profits or losses. Outside the U.S., AbbVie will be responsible for conducting and funding of any commercialization of duvelisib, and Infinity is eligible to receive tiered royalties on net product sales, with percentages ranging from 23.5 percent to 30.5 percent.

For sales of duvelisib in the U.S., AbbVie and Infinity will share equally the existing royalty obligations to Mundipharma International Corporation Limited/Purdue Pharmaceutical Products L.P., and Infinity will be responsible for these royalty obligations outside of the U.S. Infinity will also be responsible for the existing royalty obligations to Millennium: The Takeda Oncology Company for sales of duvelisib worldwide.


As part of the strategic collaboration, the companies will share responsibility for the conduct of specific trials specified within an agreed-upon global development plan, with each company leading the development of certain trials within the plan. For the initial global development plan agreed to by the companies, Infinity will fund the trials it conducts and the companies will share equally the funding of trials conducted by AbbVie. The agreement includes plans to launch multiple Phase 2 and Phase 3 studies of duvelisib in hematologic malignancies over the next several years.

Conference Call Today at 8:30 a.m. ET/7:30 a.m. CT

Infinity will hold a conference call at 8:30 a.m. to discuss the strategic collaboration announced today. A live webcast of the conference call can be accessed in the Investors/Media section of Infinity’s website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 97402440. An archived version of the webcast will be available on Infinity’s website for 30 days.

About the Development of Duvelisib for the Treatment of Blood Cancers

Infinity and AbbVie are developing duvelisib, an oral inhibitor of Class I PI3K-delta,gamma. The PI3Ks are a family of enzymes involved in multiple cellular functions, including cell proliferation and survival, cell differentiation, cell migration and immunity. The PI3K-delta,gamma isoforms are preferentially expressed in leukocytes (white blood cells), where they have distinct and mostly non-overlapping roles in immune cell development and function. Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities to develop differentiated therapies for the treatment of hematologic malignancies.

In 2013, Infinity launched the DUETTS TM ( Du v e lisib T rials in Hema t ologic Malignancie s ) program, a worldwide investigation of duvelisib in blood cancers. As part of the DUETTS program, patient enrollment is ongoing in DYNAMO TM , a Phase 2 monotherapy study designed to evaluate the safety and efficacy of duvelisib in patients with refractory indolent non-Hodgkin lymphoma (iNHL) (ClinicalTrials.gov Identifier NCT01882803), and DUO TM , a Phase 3 monotherapy study designed to evaluate the safety and efficacy of duvelisib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) (NCT02004522). DYNAMO+R TM , a Phase 3 study of duvelisib in combination with rituximab in patients with previously treated follicular lymphoma (NCT02204982), is expected to start in 2014.

Additionally, a Phase 1 study of duvelisib in patients with advanced blood cancers is ongoing (NCT01476657).


About Infinity Pharmaceuticals, Inc.

Infinity is an innovative biopharmaceutical company dedicated to discovering, developing and delivering best-in-class medicines to people with difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. For more information on Infinity, please refer to the company’s website at www.infi.com .

About AbbVie Inc.

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com . Follow @abbvie on Twitter or view careers on AbbVie’s Facebook or LinkedIn page.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the Company’s expectations about: the receipt of upfront, milestone, royalty and other payments under the agreement with AbbVie; the therapeutic and commercial potential of duvelisib; the expected benefits of the collaboration with AbbVie; the advancement of duvelisib through clinical trials; plans to conduct additional clinical trials of duvelisib; and its ability to execute on its strategic plans. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. For example, there can be no guarantee that Infinity will report data in the time frames it has estimated, that any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases, or that development of any of Infinity’s product candidates will continue. Further, there can be no guarantee that Infinity’s strategic collaboration with AbbVie will continue or that any positive developments in Infinity’s product portfolio will result in stock price appreciation. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Infinity’s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; a failure of Infinity and/or AbbVie to fully perform under the strategic collaboration and/or an early termination of the collaboration and license agreement; the content and timing of decisions made by the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Infinity’s ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of agents by Infinity’s competitors for diseases in which Infinity is currently developing or intends to develop its product candidates; and Infinity’s ability to obtain, maintain and enforce patent and other intellectual property protection for


any product candidates it is developing. These and other risks which may impact management’s expectations are described in greater detail under the caption “Risk Factors” included in Infinity’s quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 11, 2014, and other filings filed by Infinity with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

###


EXHIBIT F

AbbVie Combination Compound

[**]

Exhibit 10.3

FIRST AMENDMENT TO FACILITY AGREEMENT

This FIRST AMENDMENT TO FACILITY AGREEMENT (the “First Amendment”), dated as of September 22, 2014, by and among Infinity Pharmaceuticals, Inc., a Delaware corporation (the “Borrower”), and the lenders party hereto, set forth on the signature page of this First Amendment (together with their successors and assigns, the “Lenders” and together with the Borrower, the “Parties”), amends that certain Facility Agreement dated as of February 24, 2014 by and among the Parties (the “Original Agreement” and as amended by the First Amendment, the “Facility Agreement”). Capitalized terms used herein without definition shall have the meanings ascribed to such terms in the Original Agreement.

WITNESSETH

WHEREAS, the Parties are party to the Original Agreement providing for loans to the Borrower, on the terms and conditions stated in the Original Agreement, in the maximum principal amount of up to One Hundred Million Dollars ($100,000,000); and

WHEREAS, the Parties desire to reduce the amount of loans to be made available under the Facility Agreement from a maximum principal amount of up to One Hundred Million Dollars to a maximum principal amount of up to Fifty Million Dollars ($50,000,000.00) and terminate the commitment of certain Lenders.

NOW THEREFORE, in consideration of the mutual agreements set forth herein, the Parties agree as follows:

1. Amendments to Original Agreement .

Upon execution of this First Amendment by the Parties, the Original Agreement shall be deemed to be amended as follows:

a. The first recital of the Original Agreement shall be amended by deleting the reference to the words and dollar figure “one hundred million dollars ($100,000,000)” where it appears therein and inserting in substitution therefor the words and dollar figure “fifty million dollars ($50,000,000).”

b. The definition of “Commitment” in Section 1.1 of the Original Agreement is hereby amended by deleting the reference to the dollar figure “$100,000,000” where it appears therein and inserting in substitution therefor the dollar figure “$50,000,000.”

c. The definition of “Loans” in Section 1.1 of the Original Agreement is hereby amended by deleting the reference to the words and dollar figure “one hundred million Dollars ($100,000,000)” where it appears therein and inserting in substitution therefor the words and dollar figure “fifty million dollars ($50,000,000)”.


d. Section 2.3(a) of the Original Agreement is hereby amended by deleting it in its entirety inserting in substitution thereof the following:

“The Borrower shall pay to each Lender holding a Note one-third of the outstanding principal amount of such Note on each of the third, fourth and fifth anniversaries of the date of the first Disbursement; provided however that the Final Payment shall be made by December 15, 2019.”

e. Section 2.9 of the Original Agreement is hereby amended by deleting the dollar figure “$100,000,000” where it appears therein and inserting in substitution therefor the dollar figure “$50,000,000.”

f. Section 6.14 of the Original Agreement is hereby amended by deleting the dollar figure “$100,000,000” where it appears therein and inserting in substitution therefor the dollar figure “$50,000,000.”

g. Schedule 1 to the Original Agreement is hereby deleted in its entirety and Schedule 1 to this First Amendment is inserted in substitution therefor.

h. Notwithstanding anything in the Facility Agreement to the contrary, from and after the date of this First Amendment, Deerfield Private Design Fund II, L.P. and Deerfield Private Design International II, L.P. shall cease to have the ability to vote on any consents, amendments, waivers or modifications or other matters under the Facility Agreement, other than consents, amendments, waivers or modifications that would affect their rights under Section 2.10 of the Facility Agreement. Such Lenders shall however, retain all of their other rights under the Facility Agreement and the other Loan Documents.

2. Continuing Validity . Except as expressly modified pursuant to this First Amendment, the terms of the Original Agreement and the other Loan Documents remain unchanged and in full force and effect. The Lenders’ agreement to modifications to Original Agreement pursuant to this First Amendment in no way shall obligate the Lenders to make any future modifications to the Facility Agreement .

3. Incorporation by Reference . The provisions of Sections 6.4, 6.7 and 6.8 of the Original Agreement are hereby incorporated into this First Amendment as if set forth in full herein.

4. Fees and Expenses . The Borrower shall reimburse the Lenders for their documented legal fees and expenses in connection with the negotiation, documentation and closing of this First Amendment.


IN WITNESS WHEREOF, the Lenders and the Borrower have caused this First Amendment to be duly executed as of the date first set forth above.

 

BORROWER:
INFINITY PHARMACEUTICALS, INC.
By:  

/s/ Lawrence E. Bloch

Name: Lawrence E. Bloch
Title:   EVP, CFO and CBO
LENDERS:
DEERFIELD PRIVATE DESIGN FUND II, L.P.
By:   Deerfield Mgmt., L.P., its General Partner
By:   J.E. Flynn Capital, LLC, its General Partner
By:  

/s/ David J. Clark

Name:   David J. Clark
Title:   Authorized Signatory
DEERFIELD PRIVATE DESIGN INTERNATIONAL II, L.P.
By:   Deerfield Mgmt., L.P. its General Partner
By:   J.E. Flynn Capital, LLC, its General Partner
By:  

/s/ David J. Clark

Name: David J. Clark
Title:   Authorized Signatory
DEERFIELD PARTNERS, L.P.
By:   Deerfield Mgmt., L.P., its General Partner
By:   J.E. Flynn Capital, LLC, its General Partner
By:  

/s/ David J. Clark

Name: David J. Clark
Title:   Authorized Signatory
DEERFIELD INTERNATIONAL MASTER FUND, L.P.
By:   Deerfield Mgmt., L.P. its General Partner
By:   J.E. Flynn Capital, LLC, its General Partner
By:  

/s/ David J. Clark

Name: David J. Clark
Title:   Authorized Signatory


SCHEDULE 1

 

LENDER

   ALLOCATION OF
DISBURSEMENTS AND
PREPAYMENTS AND
ALLOCATION OF WARRANTS
ISSUED PURSUANT TO

SECTION 2.10(b)
 

Deerfield Private Design Fund II, L.P.

     0

Deerfield Private Design International II, L.P.

     0

Deerfield Partners, L.P.

     44.90

Deerfield International Master Fund, L.P.

     55.10

 

LENDER

   ALLOCATION OF WARRANTS
ISSUED PURSUANT TO

SECTION 2.10(a)
 

Deerfield Private Design Fund II, L.P.

     23.30

Deerfield Private Design International II, L.P.

     26.70

Deerfield Partners, L.P.

     22.45

Deerfield International Master Fund, L.P.

     27.55

Exhibit 10.4

LEASE

OF PREMISES AT 784 MEMORIAL DRIVE

CAMBRIDGE, MASSACHUSETTS

FROM

BHX, LLC, AS TRUSTEE OF 784 REALTY TRUST

TO

INFINITY PHARMACEUTICALS, INC.


TABLE OF CONTENTS

 

     Page  

SUMMARY OF BASIC TERMS

     i   

ARTICLE I

     1   

ARTICLE II

     7   

Section 2.1 Lease of the Premises

     7   

Section 2.2 Outside Areas

     7   

Section 2.3 Parking

     7   

Section 2.4 Declaration Common Areas

     7   

Section 2.5 Lease Term

     7   

Section 2.6 Security Deposit

     8   

Section 2.7 Lease Amendment

     9   

ARTICLE III

     9   

Section 3.1 Base Building Work

     9   

Section 3.2 TI Work

     11   

Section 3.3 Latent Defect Work

     12   

Section 3.4 Latent Hazardous Materials Work

     12   

Section 3.5 Responsibility for Costs

     12   

Section 3.6 Landlord’s Specific Repairs

     14   

Section 3.7 Signs

     14   

ARTICLE IV

     15   

Section 4.1 Base Rent

     15   

Section 4.2 Certain Additional Rent

     16   

Section 4.3 Taxes

     16   

Section 4.4 Operating Costs

     17   

Section 4.5 Utility Costs

     18   

Section 4.6 Tenant’s Audit Rights

     18   

ARTICLE V

     19   

Section 5.1 Permitted Use

     19   

Section 5.2 Restrictions on Use

     19   

Section 5.3 Hazardous Materials

     19   

Section 5.4 ADA

     20   

Section 5.5 Outside Equipment

     20   

ARTICLE VI

     20   

Section 6.1 Landlord’s Services

     20   

Section 6.2 Tenant-Assumed Services

     22   

Section 6.3 Interruption

     23   

Section 6.4 Additional Services

     23   

Section 6.5 Declaration

     23   

Section 6.6 Landlord Indemnity

     24   

ARTICLE VII

     24   

Section 7.1 Rent

     24   

Section 7.2 Utilities

     24   

Section 7.3 No Waste

     24   

Section 7.4 Maintenance; Repairs; and Yield-Up

     25   

Section 7.5 Alterations by Tenant

     25   

Section 7.6 Trade Fixtures and Equipment

     26   

Section 7.7 Compliance with Laws

     26   

Section 7.8 Contents at Tenant’s Risk

     27   

Section 7.9 Exoneration; Indemnification and Insurance

     27   

Section 7.10 Landlord’s Access

     28   

Section 7.11 No Liens

     28   

 

i


ARTICLE VIII

     28   

Section 8.1 Subletting and Assignment

     28   

ARTICLE IX

     31   

Section 9.1 Subordination to Mortgages and Ground Leases

     31   

Section 9.2 Lease Superior at Mortgagee’s or Ground Lessor’s Election

     31   

Section 9.3 Notice to Mortgagee and Ground Lessor

     32   

Section 9.4 Limitations on Obligations of Mortgagees, Ground Lessors and Successors

     32   

Section 9.5 Estoppel Certificates

     32   

ARTICLE X

     33   

Section 10.1 Damage From Casualty

     33   

Section 10.2 Abatement of Rent

     34   

Section 10.3 Landlord’s Right to Terminate

     34   

ARTICLE XI

     34   

Section 11.1 Eminent Domain; Right to Terminate and Abatement in Rent

     34   

Section 11.2 Restoration

     35   

Section 11.3 Landlord to Control Eminent Domain Action

     35   

ARTICLE XII

     35   

Section 12.1 Event of Default

     35   

Section 12.2 Landlord’s Remedies

     36   

Section 12.3 Reimbursement of Landlord

     37   

Section 12.4 Landlord’s Right to Perform Tenant’s Covenants

     37   

Section 12.5 Cumulative Remedies

     38   

Section 12.6 Expenses of Enforcement

     38   

Section 12.7 Landlord’s Default

     38   

Section 12.8 Limitation of Liability

     39   

Section 12.9 Late Payment and Administrative Expense

     39   

ARTICLE XIII

     40   

Section 13.1 Brokers

     40   

Section 13.2 Quiet Enjoyment

     40   

Section 13.3 Tenant’s Request for Landlord’s Action

     40   

Section 13.4 Notices

     40   

Section 13.5 Waiver of Subrogation

     40   

Section 13.6 Entire Agreement; Execution; Time of the Essence and Headings and Table of Contents

     40   

Section 13.7 Partial Invalidity

     41   

Section 13.8 No Waiver

     41   

Section 13.9 Holdover

     41   

Section 13.10 When Lease Becomes Binding

     41   

Section 13.11 Recordation

     41   

Section 13.12 As Is

     41   

Section 13.13 Financial Statements; Certain Representations and Warranties

     42   

Section 13.14 Confidentiality

     42   

Section 13.15 Lease Effectiveness Conditions

     43   

Section 13.16 Summary of Basic Terms

     43   

Section 13.17 Waiver of Lien

     43   

Section 13.18 Announcements

     43   

Section 13.19 Force Majeure

     43   

 

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Exhibits:

A    Property Description
B    Site Plan
C    Building Floor Plan
D    Base Building Work
E    Form of Letter of Credit
F    Notice to Parcel B Owner
G-1    Subordination, Non-Disturbance and Attornment Agreement (Union Security Insurance Company)
G-2    Subordination, Non-Disturbance and Attornment Agreement (future lender)
H    Form of Notice of Lease

 

Schedules:

2.1    Encumbrances
3.2(b)    Programming Elements for Tenant Improvements
3.2(c)    Approved Contractors for TI Work
5.3    Environmental Reports
6.1(b)    Specifications for Building Systems
6.1(f)    Janitorial Schedule
6.5    Estoppel Certificate of Parcel B Owner
13.15    Letter Agreement

 

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SUMMARY OF BASIC TERMS

LEASE

OF PREMISES AT 784 MEMORIAL DRIVE

CAMBRIDGE, MASSACHUSETTS

TO

INFINITY PHARMACEUTICALS, INC.

DATED AS OF SEPTEMBER 25, 2014

The following is a summary of certain basic terms of this Lease which is intended for the convenience and reference of the parties. Capitalized terms used, but not defined, in this Summary of Basic Terms have their defined meanings in this Lease. In addition, some of the following items or terms are incorporated into this Lease by reference to the item or term or to this Summary of Basic Terms.

 

1. Landlord : BHX, LLC, a Massachusetts limited liability company, as Trustee of 784 Realty Trust under Declaration of Trust dated December 21, 1999, recorded with the Middlesex South Registry of Deeds on December 29, 1999 as Instrument No. 827, and filed with the Middlesex Registry District of the Land Court on December 29, 1999 as Document No. 1127477.

 

2. Tenant : Infinity Pharmaceuticals, Inc., a Delaware corporation.

 

3A. Premises : The entire Building, containing an agreed upon 61,000 square feet of leasable space.

 

3B. Project : The real property with the Building and any other improvements now or hereafter thereon, commonly known as 784 Memorial Drive, Cambridge, Massachusetts, as described on Exhibit A and depicted on Exhibit B .

 

3C. Leasable Square Footage of the Premises : 61,000 square feet.

 

3D. Leasable Square Footage of the Building : 61,000 square feet.

 

4A. Base Building Work : Tenant shall design and perform the Base Building Work as set forth in Section 3.1.

 

4B. TI Work : Tenant shall design and perform the TI Work as set forth in Section 3.2.

 

4C. Allowances : Landlord shall provide Tenant (i) an allowance for the actual Base Building Costs in the amount of $2,800,000 (the “ Base Building Allowance ”), (ii) an allowance for the actual TI Costs in the amount of $3,050,000 ($50.00 per square foot) (the “ TI Allowance ”), and (iii) an allowance for the actual costs of preliminary space planning for the Premises in the amount of $6,100 ($0.10 per square foot) (the “ Space Planning Allowance ”). If the TI Costs exceed the TI Allowance, Landlord shall, at the request of Tenant as provided in Section 3.5(b)(iv), provide Tenant an additional allowance in an amount up to $1,220,000 ($20.00 per square foot) (the “ Supplemental Allowance ”) for the actual TI Costs; provided that if Landlord provides the Supplemental Allowance, the monthly installments of Base Rent shall be increased as provided in Section 3.5(b)(iv). The allowances shall be disbursed and applied as provided in Section 3.5.

 

5A. Commencement Date : November 1, 2014.

 

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5B. Base Rent Commencement Date : April 1, 2015.

 

5C. Lease Term : From the Commencement Date through March 31, 2025, subject to extension as provided in Section 2.5(b).

 

5D. Extension : Tenant shall have the right to extend the Lease Term for up to two terms of five years each in accordance with Section 2.5(b).

 

6. Permitted Use : The Premises may be used for general office purposes and, subject to Legal Requirements, uses accessory to general offices only and for no other purpose.

 

7. Security Deposit : $1,000,000, subject to reduction as provided in Section 2.6(c). The Security Deposit shall be in the form of cash or Letter of Credit, as provided in Section 2.6.

 

8. Tenant’s Parking Allocation : Tenant shall have the right to use up to 105 parking spaces on Parcel B and the parking spaces in the turnaround in front of the Building, as provided in Section 2.3.

 

9. Base Rent : The Base Rent for the Initial Term shall be as follows (subject to increase pursuant to Section 3.5(b)(iv) if Landlord provides the Supplemental Allowance):

 

PERIOD

   ANNUAL
RATE
     MONTHLY
RATE
     PSF
RATE
 

Commencement Date until Base Rent Commencement Date*

     -0-         -0-         -0-   

Base Rent Commencement Date through fifth Lease Year

   $ 2,043,500.00       $ 170,291.67       $ 33.50   

Sixth through tenth Lease Years

   $ 2,287,500.00         190,625.00       $ 37.50   

If Landlord provides the Supplemental Allowance, the Base Rent provided for above will be increased as provided in Section 3.5(b)(iv).

The Base Rent for each Extension Term will be as provided in Section 4.1(b).

 

10. Additional Rent : Tenant’s Share of Operating Costs, Tenant’s Share of Taxes, and the Utility Costs, each as more fully provided in Article IV, and all other fees, charges, expenses, fines, assessments, interest, indemnities and other sums payable by Tenant under this Lease.

 

11. Brokers : CB Richard Ellis/New England, having an office at 33 Arch Street, 28 th Floor, Boston, MA 02110, and The Bulfinch Companies, Inc., having an office at First Needham Place, 250 First Avenue, Suite 200, Needham, MA 02494.

 

12A. Tenant’s Address For Notices, Telephone Number, Email and Taxpayer Identification No.:

Infinity Pharmaceuticals, Inc.

780 Memorial Drive

Cambridge, MA 02139

Attn: Chief Executive Officer

Telephone: 617-453-1000; Email: adelene.perkins@infi.com

Tenant F.I.D.#33-0655706

 

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with a copy to:

DLA Piper LLP (US)

33 Arch Street

Boston, MA 01220

Attn: Geoff Howell., Esq.

Telephone: 617-406-6008; Email: geoff.howell@dlapiper.com

 

12B. Landlord’s Address for Notices :

BHX, LLC, as Trustee of 784 Realty Trust

c/o The Bulfinch Companies, Inc.

First Needham Place

250 First Avenue, Suite 200

Needham, MA 02494

Attention: Robert A Schlager

Telephone: (781) 707-4000; Email: ras@bulfinch.com

with a copy to:

Vorys, Sater, Seymour and Pease LLP

301 East Fourth Street, Suite 3500

Cincinnati, OH 45202

Attn: Charles C. Bissinger, Jr., Esq.

Telephone: (513) 723-4000; Email: ccbissinger@vorys.com

 

iii


LEASE

THIS LEASE (this “ Lease ”), made as of the 25 th day of September, 2014, between BHX, LLC, a Massachusetts limited liability company, as Trustee of 784 Realty Trust, and INFINITY PHARMACEUTICALS, INC., a Delaware corporation, is as follows.

W I T N E S S E T H :

ARTICLE I

CERTAIN DEFINITIONS

In addition to the words and terms defined elsewhere in this Lease, the following words and terms shall have in this Lease the meanings given in this Article:

Additional Rent ” has the meaning given in Item 10 of the Summary of Basic Terms.

Bankruptcy Laws ” means any existing or future bankruptcy, insolvency, reorganization, dissolution, liquidation or arrangement or readjustment of debt law or any similar existing or future law of any applicable jurisdiction, or any laws amendatory thereof or supplemental thereto, including, without limitation, the United States Bankruptcy Code of 1978, as amended (11 U.S.C. Section 101 et seq .), as any or all of the foregoing may be amended or supplemented from time to time.

Base Building Allowance ” has the meaning given in Item 4C of the Summary of Basic Terms.

Base Building Costs ” means all costs of designing and performing the Base Building Work.

Base Building Plans ” means the plans and specifications for the Base Building Work, to be prepared by Tenant’s Architect as provided in Section 3.1(b).

Base Building Work ” means the detailed scope of work described in Exhibit D hereto.

Base Rent ” has the meaning given in Item 9 of the Summary of Basic Terms.

Base Rent Commencement Date ” has the meaning given in Item 5B of the Summary of Basic Terms.

Brokers ” has the meaning given in Item 11 of the Summary of Basic Terms.

Building ” means the building located at the Project commonly known as 784 Memorial Drive, Cambridge, Massachusetts, as depicted on the Site Plan.

Business Days ” mean Monday through Friday, except holidays. The term “holiday” shall mean (a) the federal day of celebration of the following holidays: New Year’s Day, President’s Day, Memorial Day, July 4th, Labor Day, Thanksgiving, Christmas and (b) the Friday after Thanksgiving.

Capital Operating Costs ” means all costs of repairs, replacements and improvements made by Landlord to the Project that, under GAAP, would be capitalized.

Commencement Date ” has the meaning given in Item 5A of the Summary of Basic Terms.

Declaration ” means the Declaration of Easements, Covenants, Conditions and Restrictions, dated December 22, 1999, by 784 Memorial Drive LLC, filed with the Middlesex South Registry District of the Land Court as Document No. 1127474 and recorded in the Middlesex South Registry of Deeds on December 29, 1999, in Book 31008, Page 1, as amended by the First Amendment to Declaration of Easements, Covenants, Conditions and Restrictions, dated September 17, 2001, by 784 Memorial Drive LLC, ARE 770/784/790 Memorial Drive LLC and Landlord, filed with the Middlesex South Registry District of the Land Court as Document No. 1195705 and recorded in the Middlesex South Registry of Deeds in Book 34522, Page 324.

 

1


Encumbrances ” has the meaning given in Section 2.1.

Environmental Law ” means the Comprehensive Environmental Response, Compensation, and Liability Act (“ CERCLA ”), 42 U.S.C. §9601 et seq . , the Resource Conservation and Recovery Act, 42 U.S.C. §6901 et seq . , the Hazardous Materials Transportation Act, 49 U.S.C. §1802 et seq. , the Toxic Substances Control Act, 15 U.S.C. §2601 et seq. , the Federal Water Pollution Control Act, 33 U.S.C. §1251 et seq. , the Clean Water Act, 33 U.S.C. §1321 et seq. , the Clean Air Act, 42 U.S.C. §7401 et seq. , the Massachusetts Oil and Hazardous Material Release Prevention and Response Act, Chapter 21E of the Massachusetts General Laws, all regulations promulgated thereunder, and any other federal, state, county, municipal, local or other statute, law, ordinance or regulation (including any state or local board of health rules, regulation, or code), or any common law (including common law that may impose strict liability or liability based on negligence), which may relate to or deal with human health, the environment, natural resources, or Hazardous Materials, all as may be from time to time amended or modified.

Event of Default ” means any of the events listed in Section 12.1.

Excess Base Building Allowance ” means, if applicable, any unused portion of the Base Building Allowance remaining after completion of the Base Building Work and payment of all Base Building Costs as established to the reasonable satisfaction of Landlord, including by such certifications, lien waivers and other documents from Tenant, Tenant’s contractor and Tenant’s Architect as Landlord may reasonably request (provided that lien waivers shall not be required from subcontractors performing work with an aggregate cost of less than $50,000 in any one instance).

Excluded Items ” means the following: (a) debt service and ground rent payments; (b) any cost or expenditure for which Landlord is entitled to reimbursement by insurance proceeds or eminent domain proceeds; (c) costs for which Landlord is entitled to reimbursement under warranties; (d) salaries and bonuses of officers and executives of Landlord and administrative employees above the level of property manager or building supervisor and Landlord’s general overhead; (e) the cost of any additions to the Building; (f) any cost, other than the management fee provided for in the definition of Operating Costs, otherwise included in Operating Costs representing an amount paid to a person or entity affiliated with Landlord which is in excess of the amount which would have been paid on an arms-length basis in the absence of such relationship; (g) depreciation, amortization and Capital Operating Costs, other than Permitted Capital Operating Costs; (h) costs of selling, syndicating, financing, mortgaging or hypothecating any of Landlord’s interest in the Project; (i) costs of any disputes between Landlord and its employees; (j) legal fees which are not for the enforcement or protection of rights that benefit Tenant; (k) legal fees in excess of $5,000 for any matter involving the enforcement or protection of rights that benefit Tenant, unless Tenant has authorized legal fees in excess of $5,000 for such matter in writing prior to Landlord incurring such costs; (l) costs of performing any Tenant-Assumed Service; (m) costs incurred to remove, remedy, contain, monitor or treat any Hazardous Materials on, in or about or emanating from the Project (including, without limitation, Hazardous Materials in the ground water or soil); (n) costs, fees and expenses associated with the formation and administration of the ownership entity constituting Landlord, and of its affiliates, such as costs of tax returns or appraisals (but excluding preparation of financial reports required by this Lease); (o) advertising, marketing costs and leasing commissions associated with leasing space in the Building; (p) costs of so-called leasehold improvements to rentable areas in the Building; (q) costs for which Landlord is entitled to reimbursement by third parties; (r) legal and accounting expenses related to lease negotiations and enforcement of leases; (s) damages, penalties, fines or interest that Landlord is obligated to pay by reason of any tort liability of Landlord, Landlord’s violation of Legal Requirements or failure by Landlord to comply with its lease obligations or to timely pay any component of Operating Costs; (t) charitable and political contributions; (u) costs incurred by Landlord as a result of Landlord’s breach of this Lease; (v) compensation paid to any Person to the extent that the same is not fairly allocable to the work or service provided by such Person to the Project; (w) Taxes and any estate, succession, inheritance, profit, use, occupancy, gross receipts, rental, capital gains

 

2


and transfer taxes imposed upon Landlord; (x) any bad debt loss, rent loss or reserves for bad debts or rent loss; (y) any expenses which are not paid or incurred in respect of the Project but rather in respect of other real property owned by Landlord or affiliates of Landlord; (z) costs incurred with respect to a sale or transfer of all or any portion of the Property or any interest therein or in any Person of whatever tier owning an interest therein; (AA) costs of works or services for particular tenants (including Tenant) that are separately reimbursable to Landlord by such tenant; (BB) costs paid directly by individual tenants, including Tenant, to suppliers, including tenant electricity and telephone costs; (CC) interest or penalties for late payment by Landlord; (DD) reserves; (EE) advertising or marketing expenses; (FF) brokerage fees and commissions; (GG) exactions and impact fees paid to governmental bodies; (HH) charitable or political contributions; and (I) fines and penalties.

Extension Term ” means, as applicable, (a) the period of five years beginning at the end of the Initial Term, and (b) the period of five years beginning at the end of the first Extension Term.

GAAP ” means generally accepted accounting principles, consistently applied.

Hazardous Materials” means, at any time, (a) any “hazardous substance” as defined in §101(14) of CERCLA (42 U.S.C. §9601(14)) or regulations promulgated thereunder; (b) any “solid waste,” “hazardous waste,” or “infectious waste,” as such terms are defined in any Environmental Law at such time; (c) asbestos, urea-formaldehyde, polychlorinated biphenyls (“PCBs”), bio-medical materials or waste, nuclear fuel or material, chemical waste, radioactive material, explosives, known carcinogens, petroleum products and by-products and other dangerous, toxic or hazardous pollutants, contaminants, chemicals, materials or substances which may be hazardous to human or animal health or the environment or which are listed or identified in, or regulated by, any Environmental Law; and (d) any additional substances or materials which at such time are classified or considered to be hazardous or toxic under any Environmental Law.

Initial Term ” means the period beginning at 12:01 a.m. on the Commencement Date and ending at 11:59 p.m. on March 31 , 2025.

Insurance Costs ” includes the cost of insuring the entire Project, including without limitation the Building and other improvements now or hereafter situated thereon, and all operations conducted in connection therewith, with such policies, coverages and companies and in such limits as are required pursuant to Section 6.1(h); provided that the costs of any insurance covering debt service or similar financing charges shall be excluded from Insurance Costs. The costs of environmental liability insurance reasonably allocable to the Project, amortized on a straight-line basis over the term of the insurance policy, up to a maximum of $5,000 in any year, may be included in Insurance Costs if a copy of the applicable insurance policy and an endorsement reasonably satisfactory to Tenant naming Tenant as an additional insured is provided to Tenant.

Invitees ” means, as to Landlord or Tenant, its employees, workers, visitors, guests, customers, suppliers, agents, contractors, representatives, licensees and other invitees (other than persons under the direction or control of the other party to this Agreement).

Land ” means the land located at 784 Memorial Drive, Cambridge, Massachusetts, more particularly described in Exhibit A hereto and which is depicted on the Site Plan.

Landlord ” means BHX, LLC, a Massachusetts limited liability company, as Trustee of 784 Realty Trust, its successors and assigns.

Landlord’s Services ” means the Services to be performed by Landlord as provided in Section 6.1, being all of the Services other than the Tenant-Assumed Services.

Latent Defect ” means any defect in the Building which (a) exists as of the date of this Lease, (b) is discovered by Tenant after the date of this Lease in the course of performing the Base Building Work, (c) was not reasonably discoverable by visual inspection of Tenant on the basis of Tenant’s due diligence prior to the date of this Lease, and (d) affects Base Building Work; provided that Latent Hazardous Materials shall not constitute a Latent Defect.

 

3


Latent Defect Costs ” means all costs of designing and performing the Latent Defect Work, if any.

Latent Defect Work ” means the work reasonably necessary to correct Latent Defects, if any.

Latent Hazardous Materials ” means Hazardous Materials which (a) exist in the Building as of the date of this Lease, (b) are in violation of Environmental Laws or the presence of which otherwise increases the cost to perform the Base Building Work (e.g. asbestos containing materials that are below reportable thresholds but that require special handling or precautions), and (c) are discovered by Tenant after the date of this Lease in the course of performing the Base Building Work.

Latent Hazardous Materials Costs ” means all costs of designing and performing the Latent Hazardous Materials Work, if any.

Latent Hazardous Materials Work ” means the work reasonably necessary to remediate the Latent Hazardous Materials, if any.

Lease Effectiveness Conditions ” has the meaning given in Section 13.15.

Lease Term ” means the Initial Term and, if Tenant timely and properly exercises its right to extend pursuant to Section 2.5(b), each Extension Term as to which Tenant exercises such right.

Lease Year ” means the 12 month period beginning on each April 1 throughout the Lease Term; provided that the first Lease Year shall also include the period from the Commencement Date until the Base Rent Commencement Date.

Legal Requirements ” means all applicable laws, statutes, rules, regulations and requirements of governmental authorities, including, but not limited to, zoning laws and building codes.

Operating Costs ” means all reasonable costs, expenses and disbursements of every kind and nature (except Taxes) which Landlord shall pay in connection with performing Landlord’s Services in accordance with this Lease. Operating Costs shall include, by way of illustration, but not be limited to, all reasonable costs or charges paid by Landlord for or in connection with any of the following: the performance of Landlord’s maintenance and repair obligations with respect to the Project; providing janitorial service to the Project; the maintenance, repair and replacement of HVAC equipment and systems; providing utility services to the Project; operating any shuttle or other transportation service between the Project and public transportation stations (if any); any police details at any entrances to the Project if required to undertake repairs and maintenance, requested by Tenant or required by Legal Requirements; removal of trash, debris, and refuse; removal of snow and ice; pest and vermin control; providing, maintaining, repairing and replacing paving, curbs, walkways, landscaping, planters, roofs, walls, drainage, utility lines, security systems and other equipment; painting the exterior of the Building; repaving, resurfacing and restriping parking areas and drives; lighting, cleaning, waterproofing, repairing and maintaining Outside Areas; licenses, permits and inspection fees; legal, accounting, inspection and third-party consultant fees; Permitted Capital Operating Costs; wages, salaries and benefits of operating personnel, including welfare, retirement, vacations and other compensation and fringe benefits and payroll taxes; any insurance deductible paid by Landlord in connection with an insured property loss; a management fee equal to 1.75% of gross rents (gross rents being the Base Rent plus the Additional Rent payable with respect to Operating Costs and Taxes, but expressly excluding from Operating Costs any costs incurred by Tenant for any Tenant-Assumed Services), regardless of the allocation of Services as between Landlord Services and Tenant-Assumed Services; Insurance Costs; and costs that are the responsibility of Landlord under the Declaration. However, notwithstanding the above, none of the Excluded Items shall be included in Operating Costs.

 

4


Outside Areas ” means all areas of the Project located outside of the Building, including parking areas located on the Property from time to time.

Outside Equipment ” means an emergency generator, mechanical equipment, heat exchangers, solar panels, antennas, satellite dishes and the like and related appurtenances and cabling used in connection with Tenant’s business at the Premises.

Parcel B ” has the meaning given in the Declaration.

Parcel B Owner ” has the meaning given in the Declaration.

Permitted Capital Operating Costs ” means Capital Operating Costs consisting of (a) capital repairs or replacements (as distinct from capital improvements) necessary in Landlord’s good faith judgment for the proper maintenance and repair of the Project, (b) capital repairs, replacements or improvements required by new Legal Requirements enacted and effective after the date of this Lease, or (c) capital repairs, replacements or improvements which reduce other Operating Costs, in each case amortized over their expected useful life based upon and including a market rate of interest; provided that Permitted Capital Operating Costs shall not include any portion of the Capital Operating Costs described in clause (c) above in excess of the annual reduction in Operating Costs achieved by reason of the capital repair, replacement or improvement; and provided, further, that Capital Operating Costs for the Building shell, foundation, roof, columns, façade, floor slabs and other structural elements of the Building shall not be Permitted Capital Operating Costs.

Permitted Transferee ” means (a) an entity controlling, controlled by or under common control with Tenant, (b) an entity which succeeds to Tenant’s business by merger, consolidation or other form of corporate reorganization, or (c) an entity which acquires all or substantially all of Tenant’s assets or stock; provided that an entity may not become a Permitted Transferee through or as a part of a bankruptcy or other similar insolvency proceeding.

Permitted Use ” has the meaning given in Item 6 of the Summary of Basic Terms.

Person ” means any individual, partnership, joint venture, trust, limited liability company, business trust, joint stock company, unincorporated association, corporation, institution, or entity, including any governmental authority.

Preliminary Base Building Plans ” means plans for the Base Building Work preliminary to the Base Building Plans, to be prepared by Tenant’s Architect in accordance with Section 3.1(b).

Preliminary TI Plans ” means the space plans for the Premises and other plans for the TI Work preliminary to the TI Plans, to be prepared by Tenant’s Architect in accordance with Section 3.2(b).

Premises ” has the meaning given in Item 3A of the Summary of Basic Terms.

Project ” has the meaning given in Item 3B of the Summary of Basic Terms.

Services ” has the meaning given in Section 6.1.

Site Plan ” means the site plan attached hereto as Exhibit B which depicts the approximate size and layout of the Land and the Building.

Space Planning Allowance ” has the meaning given in Item 4C of the Summary of Basic Terms.

Summary of Basic Terms” means the Summary of Basic Terms which appears immediately after the table of contents of this Lease.

Supplemental Allowance ” has the meaning given in Item 4C of the Summary of Basic Terms.

 

5


Tax Fiscal Year ” shall mean the City of Cambridge fiscal year (i.e. July 1 through June 30 next following), or such other tax period as may be established by the City of Cambridge for the payment of Taxes.

Taxes ” shall mean (a) all real estate taxes, assessments, betterments, water or sewer entrance fees and similar charges against the Project, including general, special, ordinary and extraordinary, or any other charges (including charges for the use of municipal services if billed separately from other taxes), levied, assessed or imposed at any time by any governmental authority upon or against the Land, the Building or the fixtures, signs and other improvements thereon then comprising the Project (provided that such other charges are levied, assessed or imposed against other commercial properties in the City of Cambridge) and (b) all reasonable out-of-pocket attorneys fees, appraisal fees and other fees, charges, costs and/or expenses incurred in connection with any proceedings related to the contest of amount of the Taxes, the tax classification and/or the assessed value of the Project. This definition of Taxes is based upon the present system of real estate taxation in the Commonwealth of Massachusetts; if taxes upon rentals or any other basis shall be substituted, in whole or in part, for the present ad valorem real estate taxes, the term “Taxes” shall be deemed changed to the extent to which there is such a substitution for the present ad valorem real estate taxes but only to the extent that the same would be payable if the Project were the only property of Landlord. Notwithstanding anything to the contrary contained in this Lease, the following shall be excluded from Taxes and shall be paid solely by Landlord: inheritance, estate, succession, transfer, gift, franchise, or capital stock tax, or any income taxes arising out of or related to ownership and operation of income producing real estate, or any excise taxes imposed upon Landlord based upon gross or net rentals or other income received by it. Betterment assessments and interest thereon shall be apportioned equally over the longest period permitted by law

Tenant ” means Infinity Pharmaceuticals, Inc., a Delaware corporation, its permitted successors and permitted assigns.

Tenant-Assumed Service ” has the meaning given in Section 6.2(a).

Tenant’s Architect ” means Olson Lewis + Architects or another architectural firm selected by Tenant or Tenant’s design-build contractor, if applicable, and approved by Landlord, which approval Landlord will not unreasonably withhold, condition or delay.

Tenant’s Share ” means the amount (expressed as a percentage) equal to (a) the Leasable Square Footage of the Premises divided by (b) the Leasable Square Footage of the Building, rounded to the nearest one-tenth of one percent (0.1%), being 100%.

TI Allowance ” has the meaning given in Item 4C of the Summary of Basic Terms.

TI Costs ” means all costs of designing and performing the TI Work.

TI Plans ” means the plans and specifications for the TI Work, to be prepared by Tenant’s Architect in accordance with Section 3.2(b).

TI Work ” means the alterations and improvements to be made to the Premises to prepare the Premises for Tenant’s occupancy.

Utility Costs ” means the costs for all utility services provided to the Project, including but not limited to gas, electric, telephone, cable, water and sewer service.

 

6


ARTICLE II

LEASE OF PREMISES

Section 2.1 Lease of the Premises . Landlord hereby leases the Premises to Tenant, and Tenant hereby leases the Premises from Landlord, upon and subject to the terms and provisions of this Lease, subject to all zoning ordinances and subject to and with the benefit of all easements, covenants, conditions and restrictions of record listed on Schedule 2.1 (the “ Encumbrances ”). Without limiting the generality of the immediately preceding sentence, the Premises are leased by Landlord to Tenant subject to, and together with the benefit of, the Declaration.

Section 2.2 Outside Areas . The Premises are leased with the benefit of the exclusive right to use the Outside Areas for all such purposes as such areas may be reasonably designated, but only in connection with lawful business in the Building.

Section 2.3 Parking . Tenant shall have all of the rights under the Declaration to use up to 105 of the parking spaces on Parcel B, on and subject to the terms and conditions set forth in the Declaration. Without limiting the generality of the immediately preceding sentence, Tenant shall be a “Parcel A Parking Tenant,” as defined in the Declaration, and Landlord shall give Parcel B Owner notice designating Tenant as a Parcel A Parking Tenant, effective as of the Commencement Date, with respect to 105 parking spaces or such smaller number of parking spaces which Tenant has indicated by written notice to Landlord that Tenant desires to use. At the written request of Tenant from time to time, Tenant may change the number of parking spaces being used by Tenant on Parcel B (up to 105 parking spaces), in which event Landlord will promptly communicate such change to Parcel B Owner as contemplated by the Declaration and such change shall become effective in accordance with the Declaration. In addition to designating Tenant as a Parcel A Parking Tenant, Landlord shall permit Tenant to participate with Landlord in the determination of the “Market Rent,” as defined in the Declaration, for parking spaces pursuant to Section 4.6.2(d) of the Declaration. In addition to the parking spaces on Parcel B which Tenant may use as provided above, Tenant shall have the exclusive right to use, free of charge, the parking spaces in the turnaround in front of the Building. Landlord and Tenant shall cooperate to attempt to obtain the approval of the Parcel B Owner under the Declaration to allow Tenant to exercise all of the rights of the Parcel A Owner to the parking spaces on Parcel B directly, rather than through Landlord (e.g. by notifying the Parcel B owner regarding the number of spaces to be used from time to time and for purposes of determining the Market Rent for parking established under the Declaration).

Section 2.4 Declaration Common Areas . Tenant shall have the right to use the Common Areas (as defined in the Declaration), on and subject to the terms and conditions set forth in the Declaration. Such Common Areas include the landscaped areas located immediately northerly and southerly of the Project, depicted as “Restriction Area A” and “Restriction Area B” on the site plan which is Exhibit B to the Declaration. At Tenant’s request, Landlord shall, at no out-of-pocket cost to Landlord, cooperate with Tenant in seeking the consent of Parcel B Owner to Tenant’s installation and maintenance of landscaping and landscaping elements within Restriction Area A and Restriction Area B.

Section 2.5 Lease Term .

(a) Initial Term . The Lease Term shall commence at 12:01 a.m. on the Commencement Date and shall end at 11:59 p.m. on the last day of the tenth Lease Year, subject to extension as provided in Section 2.5(b).

(b) Extension Options . Provided an Event of Default does not then exist, Tenant shall have the right to extend the Lease Term for up to two periods of five years each by giving Landlord written notice of extension, which notice must be delivered not earlier than 18 months, nor later than 12 months, prior to expiration of the Initial Term or first Extension Term, as applicable. If an extension becomes effective, the Lease Term shall be automatically extended upon the same terms and conditions as were applicable to the Initial Term, except that (i) Base Rent for such Extension Term shall be as set forth in Section 4.1(b), and (ii) there shall be no further right to extend or renew the Lease Term beyond the second Extension Term.

 

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Section 2.6 Security Deposit .

(a) Simultaneously with the execution and delivery of this Lease, Tenant shall deliver to Landlord the Security Deposit, which shall be in the form of cash or a letter of credit which satisfies the conditions of Section 2.6(b) (“ Letter of Credit ”).

(b) The Letter of Credit must satisfy all of the following conditions: (i) the Letter of Credit must be in the form attached hereto as Exhibit E , or in such other substantially similar form as Landlord may approve, with an expiration date not less than one year after the date of the Letter of Credit; (ii) the beneficiary of the Letter of Credit must be Landlord or Landlord’s lender (provided that any such lender is subject to the terms of this Section 2.6); (iii) the Letter of Credit must be irrevocable, unconditional and transferable one or more times without charge to Landlord; and (iv) the Letter of Credit must be issued by a bank satisfactory to Landlord in its reasonable discretion (Landlord acknowledging that JP Morgan Chase Bank, NA is acceptable). If, at any time, the issuer of the Letter of Credit gives notice of its election not to renew, extend and/or reissue the Letter of Credit, then Tenant shall, not later than 30 days prior to the expiration of the term of the Letter of Credit, deliver to Landlord (1) a replacement Letter of Credit satisfying all of the above conditions or (2) cash in the full amount of the expiring Letter of Credit; and if Tenant fails to timely deliver to Landlord a replacement Letter of Credit as provided above or cash in the full amount of the expiring Letter of Credit, Landlord may draw on the Letter of Credit and hold the proceeds of such drawing as the Security Deposit. If (x) Landlord shall reasonably feel insecure with the creditworthiness of the bank issuing the Letter of Credit and Tenant shall fail, within 20 days after notice, to either provide a replacement Letter of Credit as provided above or cash in the full amount of the existing Letter of Credit, or (y) Tenant fails to provide Landlord with cash in the full amount of the Letter of Credit within ten days after notice from Landlord that (I) any proceedings under the Bankruptcy Code, receivership or any insolvency law are instituted with the issuer of the Letter of Credit as debtor or (II) the bank issuing the Letter of Credit is taken over by the Federal Deposit Insurance Corporation, the Resolution Trust Corporation or a similar entity, then such failure by Tenant under clauses (x) or (y) of this sentence shall constitute an Event of Default and, in addition to any other rights which Landlord might have by reason of such Event of Default, Landlord may draw on the Letter of Credit and hold the proceeds of such drawing as part of the Security Deposit.

(c) The amount of the Security Deposit shall be subject to reduction as provided in this Section 2.6(c). The initial amount of the Security Deposit shall be $1,000,000. As of the commencement of the third Lease Year, provided that an Event of Default does not then exist and that no Event of Default has occurred during the second Lease Year, the amount of the Security Deposit shall be reduced to $500,000. As of the beginning of the fifth Lease Year, provided that Tenant qualified for the prior reduction of the Security Deposit and an Event of Default does not then exist and that no Event of Default has occurred during the fourth Lease Year, the amount of the Security Deposit shall be further reduced to $250,000. If, upon any reduction in the amount of the Security Deposit as provided above, the Security Deposit is then in the form of a Letter of Credit, then such reduction in the amount of the Security Deposit shall be accomplished by Tenant causing the issuing bank to issue (i) a replacement Letter of Credit in an amount reflecting the reduced amount of the Security Deposit, whereupon Landlord shall return the replaced Letter of Credit to the issuing bank, or (ii) an amendment of the Letter of Credit reflecting the reduced amount of the Security Deposit. Tenant shall have the right to substitute a replacement Letter of Credit meeting the criteria of this Section 2.6 from time to time. Landlord shall reasonably cooperate with Tenant in the provision of any replacement or amendment of the Letter of Credit hereunder for purposes of avoiding the need for Tenant to maintain Letters of Credit for the benefit of Landlord in amounts in excess of those required by this Lease at any one time; e.g. by use of an escrow arrangement with a third party reasonably approved by Landlord or otherwise.

(d) The Security Deposit is security for the faithful performance and observance by Tenant of Tenant’s obligations under this Lease and is not an advance payment of rent. If an Event of Default occurs, Landlord may use, apply or retain the whole or any part of the Security Deposit to the extent required for payment of any Base Rent or Additional Rent which is then due and payable or for any sum which Landlord expends by reason of the occurrence of an Event of Default, including, but not limited to, any damage or deficiency accrued before or after summary proceedings or other re-entry by

 

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Landlord, including the costs of such proceeding or re-entry and further including, without limitation, reasonable attorneys’ fees. Landlord shall always have the right to apply the Security Deposit, or any part thereof, as aforesaid, without notice (other than notices required with respect to the Event of Default) and without prejudice to any other remedy which Landlord may have, or Landlord may pursue any other such remedy in lieu of applying the Security Deposit or any part thereof. No interest shall be payable on the Security Deposit and Landlord shall have the right to commingle the Security Deposit with other funds of Landlord. If Landlord shall apply the Security Deposit in whole or in part, Tenant shall within five Business Days following demand pay to Landlord the amount so applied, or cause the Letter of Credit to be reinstated, to restore the Security Deposit to its original amount. In the event of a sale or other transfer of the Project, or leasing of the entire Project including the Premises subject to Tenant’s tenancy hereunder, Landlord shall transfer the Security Deposit then remaining to the vendee or lessee, such vendee or lessee shall thereupon become entitled to the rights and subject to the obligations of the landlord under this Lease (including the obligations with respect to the Security Deposit), and, provided that such vendee or lessee has assumed Landlord’s obligations under this Section 2.6 in writing, Landlord shall thereupon be released from all liability for the return of such Security Deposit to Tenant, and Tenant agrees to look solely to the new landlord for the return of the Security Deposit then remaining. Tenant will not assign or encumber or attempt to assign or encumber the Security Deposit, and neither Landlord nor its successors or assigns shall be bound by any such assignment, encumbrance, attempted assignment or attempted encumbrance. Upon the expiration or earlier termination of the term, Landlord shall, within 15 days thereafter, return the Letter of Credit to Tenant, provided that no Event of Default is then continuing.

Section 2.7 Lease Amendment . If, pursuant to any provision of this Lease, there results a change in any of the terms or amounts in the Summary of Basic Terms then in effect, Landlord and Tenant will promptly execute a written amendment to, and restatement of, the Summary of Basic Terms, substituting the changed terms and recomputed amounts in lieu of each of the applicable terms and amounts then in effect which have been changed. As of the effective date of the amendment to the Summary of Basic Terms, the changed terms will be effective for all purposes of this Lease, and the amended and restated Summary of Basic Terms will be a part of, and incorporated into, this Lease. The failure of the parties to enter into such an amendment shall not affect the changes to this Lease as otherwise determined pursuant to the provisions hereof.

ARTICLE III

WORK; SIGNS

Section 3.1 Base Building Work .

(a) Generally . Tenant shall design and perform the Base Building Work in accordance with this Section 3.1.

(b) Base Building Plans . Prior to commencing any Base Building Work, Tenant will cause Tenant’s Architect to prepare and submit to Landlord for review and approval Base Building Plans, consisting of construction documents for the Base Building Work sufficient to obtain a building permit from the City of Cambridge inspectional services department and for the bidding of the Base Building Work. In the process of developing the Base Building Plans, Tenant shall cause Tenant’s Architect to prepare and submit to Landlord for review and approval a set of each of schematic and design development plans as Preliminary Base Building Plans. Within five Business Days after receipt of any proposed Preliminary Base Building Plans or Base Building Plans, Landlord shall, by written notice to Tenant, reasonably approve or disapprove the same. Landlord will not unreasonably withhold its approval of proposed Preliminary Base Building Plans or Base Building Plans, and in any disapproval of proposed Preliminary Base Building Plans or Base Building Plans (in whole or in part), Landlord shall specify in reasonable detail the respects in which the Preliminary Base Building Plans or Base Building Plans are not satisfactory to Landlord and the changes which Landlord desires in order that the Preliminary Base Building Plans or Base Building Plans will be satisfactory to Landlord. After receiving any notice of disapproval from Landlord with respect to proposed Preliminary Base Building Plans or Base Building Plans, Tenant will revise the same as reasonably requested by Landlord and will resubmit the revised Preliminary Base Building Plans or Base

 

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Building Plans to Landlord for review and approval in accordance with the procedures set forth in this Section. Landlord will not disapprove any element of proposed Preliminary Base Building Plans or Base Building Plans that are provided for in, or reasonably inferable from, previously approved Preliminary Base Building Plans or the scope of work described in Exhibit D hereto. Tenant may make changes in the approved Base Building Plans only with the prior written consent of Landlord, which consent shall not be unreasonably withheld, conditioned or delayed; provided that Tenant may make minor field work changes in the approved Base Building Plans which do not, individually or in the aggregate, materially adversely affect the quality, functionality or aesthetic appearance of the Base Building Work or the Building, with notice to Landlord (without the requirement of consent) where Tenant’s general contractor is obligated to provide Tenant with notice of the same. Landlord’s approval of Preliminary Base Building Plans or Base Building Plans shall not, and shall not be deemed to, be a certification, representation or warranty by Landlord that the same are adequate, complete or in compliance with Legal Requirements, provided that nothing in this sentence shall relieve Landlord of its obligations for ongoing maintenance of the Base Building Work as described in Section 3.1(e), below. Landlord may, at its election, have one or more architects and/or engineers selected by Landlord review proposed Preliminary Base Building Plans, Base Building Plans and/or any proposed changes therein. All such reviews shall be for the sole benefit of Landlord and neither Landlord nor such architects and/or engineers shall have any liability or obligation to Tenant or any other Person with respect to the Base Building Plans or the Base Building Work.

(c) Performance of Base Building Work . Tenant shall be fully responsible for causing the Base Building Work to be performed. The general contractor or construction manager performing or managing the Base Building Work, and the contract pursuant to which such general contractor or construction manager performs or manages the Base Building Work, shall be subject to the provisions of Section 3.1(d). All of the Base Building Work shall be done in a good and workmanlike manner using new and high quality materials, in accordance with Legal Requirements and insurance requirements applicable thereto, substantially in accordance with the approved Base Building Plans, and in accordance with the requirements of Section 7.11 and other applicable provisions of this Lease. Landlord may conduct such inspections of the Base Building Work as Landlord, in its sole discretion, determines. All such inspections shall be for the sole benefit of Landlord and Landlord shall have no liability or obligation to Tenant or any other Person with respect to the Base Building Work or the performance thereof.

(d) Contractor and Contract . Tenant shall chose a general contractor or construction management firm reasonably approved by Landlord (Landlord acknowledging that The Richmond Group and TRG Builders are approved) for the performance or management of the Base Building Work and shall cause such general contractor or construction manager to bid the Base Building Work to at least three subcontractors approved by Landlord, which approval Landlord will not unreasonably withhold, condition or delay, for each trade other than the mechanical, electrical and plumbing trades, which may be bid to vendor engineered design/build subcontractors reasonably approved by Landlord. Landlord shall consult with Tenant and Tenant’s general contractor or construction manager in reviewing such bids, and Tenant shall select the lowest and best pre-qualified bid, unless otherwise approved by Landlord and such general contractor or construction manager. The general contract or the construction management agreement for the performance or management of the Base Building Work shall be a fixed price or guaranteed maximum price contract and shall be subject to the prior written approval of Landlord not to be unreasonably withheld, conditioned or delayed. If Tenant elects to have a single contractor (whether a general contractor or a construction manager) or architect design, perform or manage both the Base Building Work and the TI Work, then Tenant shall either (i) enter into a separate contract with such contractor and architect, if applicable, for each of the Base Building Work and the TI Work or (ii) enter into a single contract with such contractor and architect, if applicable, for both the Base Building Work and the TI Work which provides for a separate accounting for each of the Base Building Work and the TI Work and, with respect to construction, a separate fixed price or guaranteed maximum price for the Base Building Work. Tenant shall obtain a preliminary estimate for the fixed price or guaranteed maximum price for the Base Building Work upon Landlord’s approval of the design development documents.

 

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(e) Ongoing Maintenance . Upon completion of the Base Building Work, Tenant shall assign, on a non-exclusive basis, all contracts and warranties for the Base Building Work to Landlord. Such warranties shall include, without limitation, (i) a warranty from the general contractor or construction manager for the Base Building Work that the Base Building Work has been performed in a good and workmanlike manner, free from defects in workmanship and materials, in compliance with Legal Requirements, and substantially in accordance with the Base Building Plans, and (ii) a warranty from Tenant’s Architect that the Base Building Plans comply with all Legal Requirements. After completion of the Base Building Work, and Landlord will have the ongoing obligation to repair and maintain the same consistent with Landlord’s maintenance and repair obligations under this Lease, including the repair of any defects in the Base Building Work (provided that any costs of such repair and maintenance shall be included in Operating Costs, except to the extent of any Excluded Costs).

Section 3.2 TI Work .

(a) Generally . Tenant shall design and perform the TI Work in accordance with this Section 3.2.

(b) TI Plans . Prior to commencing any TI Work, Tenant will cause Tenant’s Architect to prepare and submit to Landlord for review and approval TI Plans, consisting of working plans and specifications for the TI Work. In the process of developing the TI Plans, Tenant may cause Tenant’s Architect to prepare and submit to Landlord for review and approval Preliminary TI Plans. Within five Business Days after receipt of proposed Preliminary TI Plans or TI Plans, Landlord shall, by written notice to Tenant, reasonably approve or disapprove the same. Landlord will not unreasonably withhold its approval of proposed Preliminary TI Plans or TI Plans, and in any disapproval of proposed Preliminary TI Plans or TI Plans (in whole or in part), Landlord shall specify in reasonable detail the respects in which the Preliminary TI Plans or TI Plans are not satisfactory to Landlord and the changes which Landlord desires in order that the Preliminary TI Plans or TI Plans will be satisfactory to Landlord. Landlord expressly acknowledges that the Preliminary TI Plans and TI Plans may include the programming elements described on Schedule 3.2(b) hereto. After receiving any notice of disapproval from Landlord with respect to proposed Preliminary TI Plans or TI Plans, Tenant will revise the same as reasonably requested by Landlord and will resubmit the revised Preliminary TI Plans or TI Plans to Landlord for review and approval in accordance with the procedures set forth in this Section. Tenant may make material changes in the approved TI Plans only with the prior written consent of Landlord, which consent shall not be unreasonably withheld, conditioned or delayed. Tenant shall be fully responsible for the compliance of the TI Plans with all Legal Requirements and for assuring that the TI Plans provide for TI Work that will be in compliance with all Legal Requirements and will satisfy Tenant’s requirements. Landlord’s approval of Preliminary TI Plans or TI Plans shall not, and shall not be deemed to, be a certification, representation or warranty by Landlord that the same are adequate, complete or in compliance with Legal Requirements. Landlord may, at its election, have one or more architects and/or engineers selected by Landlord review proposed Preliminary TI Plans, TI Plans and/or any proposed changes therein. All such reviews shall be for the sole benefit of Landlord and neither Landlord nor such architects and/or engineers shall have any liability or obligation to Tenant or any other Person with respect to the TI Plans or the TI Work.

(c) Performance of TI Work . Tenant shall be fully responsible for the performance of the TI Work. The contractor(s) performing the TI Work shall be subject to the prior written approval of Landlord, which approval shall not be unreasonably withheld, conditioned or delayed, and Tenant shall furnish to Landlord a copy of the contract(s) with such contractor(s). The contractors listed on Schedule 3.2(c) , attached, are hereby approved by Landlord for the purposes of the immediately preceding sentence. All of the TI Work shall be done in a good and workmanlike manner using new and high quality materials, in accordance with Legal Requirements and insurance requirements applicable thereto, substantially in accordance with the approved TI Plans, and in accordance with the requirements of Section 7.11 and other applicable provisions of this Lease. Landlord may conduct such inspections of the TI Work as Landlord, in its sole discretion, determines. All such inspections shall be for the sole benefit of Landlord and Landlord shall have no liability or obligation to Tenant or any other Person with respect to the TI Work or the performance thereof.

 

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Section 3.3 Latent Defect Work . If, in the course of performing the Base Building Work, Tenant discovers any Latent Defects, then, in conjunction with the performance of the Base Building Work, Tenant shall perform the Latent Defect Work. The Latent Defect Work shall be designed and performed in the same manner, and on and subject to the same terms and conditions as are applicable to, the design and performance of the Base Building Work as set forth in Section 3.1.

Section 3.4 Latent Hazardous Materials Work . If, in the course of performing the Base Building Work, Tenant discovers any Latent Hazardous Materials, then Landlord shall perform the Latent Hazardous Materials Work to remediate the Latent Hazardous Materials at its sole cost and expense. Landlord shall perform the Latent Hazardous Materials Work in a good and workmanlike manner, in accordance with Legal Requirements, and in such manner as to minimize any delay in performance of the Base Building Work or the TI Work, to the extent practical. If practical to perform the Latent Hazardous Materials Work, on the one hand, and the Base Building Work and/or TI Work, on the other hand, concurrently, Landlord and Tenant shall cooperate to coordinate such work to minimize interference of one with the other.

Section 3.5 Responsibility for Costs .

(a) Base Building Costs . Landlord shall provide the Base Building Allowance to or for the benefit of Tenant for the payment of Base Building Costs, on and subject to the terms and conditions set forth in this Section 3.5(a). Disbursement of the Base Building Allowance to or at the direction of Tenant to pay or reimburse Tenant for Base Building Costs shall be conditioned upon the subject Base Building Work having been performed in accordance with the provisions of this Lease, and shall be subject to Landlord’s receipt of a request for payment in form and with backup reasonably satisfactory to Landlord, including but not limited to such certifications, lien waivers and other documents from Tenant, Tenant’s contractor and Tenant’s Architect as Landlord may reasonably require (provided that lien waivers shall not be required from subcontractors performing work with an aggregate cost of less than $50,000 in any one instance). Tenant may request disbursements of the Base Building Allowance from time to time as the Base Building Work progresses, but not more frequently than monthly. Landlord shall make disbursements of the Base Building Allowance to or at the direction of Tenant within 30 days after receipt of Tenant’s written request and reasonably satisfactory backup documentation. Landlord may inspect the Base Building Work as a condition to making any requested disbursement of the Base Building Allowance to confirm the status of the Base Building Work and that the Base Building Work is being performed in accordance with the provisions of this Lease. All Base Building Costs in excess of the Base Building Allowance shall be paid by Tenant, without reimbursement by Landlord. Any Excess Base Building Allowance shall be available, first, for application to payment of or reimbursement for any Latent Defect Costs and Latent Hazardous Materials Costs, and second, for application to payment of or reimbursement for any TI Costs in excess of the TI Allowance.

(b) TI Costs .

(i) General . Landlord shall provide the Space Planning Allowance and the TI Allowance to or for the benefit of Tenant for the payment of TI Costs, on and subject to the terms and conditions set forth in Section 3.5(b)(ii) and Section 3.5(b)(iii), respectively. In addition, at Tenant’s request as provided in Section 3.5(b)(iv), Landlord shall provide the Supplemental Allowance to or for the benefit of Tenant for the payment of TI Costs, on and subject to the terms and conditions set forth in Section 3.5(b)(iv). Tenant shall be responsible for all TI Costs not paid or reimbursed by the Space Planning Allowance, the TI Allowance or the Supplemental Allowance, subject to availability of any Excess Base Building Allowance as provided in Section 3.5(a).

(ii) Space Planning Allowance . The Space Planning Allowance shall be disbursed and applied by Landlord to pay or reimburse Tenant for TI Costs consisting of amounts owing by Tenant to Tenant’s Architect for the Preliminary TI Plans. Landlord shall disburse the Space Planning Allowance to or for the benefit of Tenant within 30 days after receipt of Tenant’s written request and reasonably satisfactory backup documentation. All costs of the Preliminary TI Plans in excess of the Space Planning Allowance shall be paid by Tenant, without reimbursement by Landlord (except to the extent of the availability of the TI Allowance, Supplemental Allowance or Excess Base Building Allowance for reimbursement of such costs). Any unused portion of the Space Planning Allowance remaining after payment of all costs of the Preliminary TI Plans shall be added to and become a part of the TI Allowance.

 

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(iii) TI Allowance . The TI Allowance shall be disbursed and applied by Landlord to pay or reimburse Tenant for TI Costs. Disbursement of the TI Allowance to or at the direction of Tenant to pay or reimburse Tenant for TI Costs shall be conditioned upon the subject TI Work having been performed in accordance with the provisions of this Lease, and shall be subject to Landlord’s receipt of a request for payment in form and with backup reasonably satisfactory to Landlord, including but not limited to such certifications, lien waivers and other documents from Tenant, Tenant’s contractor and Tenant’s Architect as Landlord may reasonably require (provided that lien waivers shall not be required from subcontractors performing work with an aggregate value of less than $50,000 in any one instance). Tenant may request disbursements of the TI Allowance from time to time as the TI Work progresses, but not more frequently than monthly. Prior to commencement of the TI Work, Landlord and Tenant shall determine and agree upon the estimated TI Costs on the basis of the TI Plan and Tenant’s contract(s) for the performance of the TI Work (the “ Estimated TI Costs ”), and if the Estimated TI Costs exceed the TI Allowance, Landlord may limit each requested disbursement of the TI Allowance to a percentage of the TI Costs which are the subject of the disbursement request, which percentage shall be determined by dividing the TI Allowance by the Estimated TI Costs. Landlord shall make disbursements of the TI Allowance to or at the direction of Tenant within 30 days after receipt of Tenant’s written request and reasonably satisfactory backup documentation. Landlord may inspect the TI Work as a condition to making any requested disbursement of the TI Allowance to confirm the status of the TI Work and that the TI Work is being performed in accordance with the provisions of this Lease. All TI Costs in excess of the TI Allowance shall be paid by Tenant, without reimbursement by Landlord; subject, however, to the availability of the Supplemental Allowance as provided in Section 3.5(b)(iv) and the availability of any Excess Base Building Allowance as provided in Section 3.5(a). Any unused portion of the TI Allowance remaining after payment of all TI Costs shall be available for application to payment or reimbursement of Tenant for any Base Building Costs in excess of the Base Building Allowance. Tenant shall have the right to apply the TI Allowance towards general construction, data/telecommunications cabling, architectural costs (including space plans, mechanical, electrical, and plumbing work drawings), and construction management fees for the TI Work.

(iv) Supplemental Allowance . If the TI Costs exceed or are reasonably estimated to exceed the TI Allowance, then, at the written request of Tenant made no later than 60 days after the Base Rent Commencement Date, Landlord shall provide Tenant with such portion of the Supplemental Allowance, as specified in such request, to pay or reimburse Tenant for TI Costs in excess of the TI Allowance, in which case the Supplemental Allowance shall be added to the TI Allowance and disbursement of the Supplemental Allowance shall be subject to the same terms and conditions as are applicable to disbursements of the TI Allowance as set forth in Section 3.5(b)(iii). If Landlord provides the Supplemental Allowance, then the monthly installments of Base Rent shall be increased by the amount that would fully amortize the Supplemental Allowance, together with interest at a per annum rate equal to the higher of (A) 8.50% or (B) the sum of 1.50% plus the prime rate of Bank of America as of the date of the first disbursement of the Supplemental Allowance, in equal consecutive monthly installments of principal and interest on the first day of each calendar month commencing with the first day of the first calendar month first occurring on or after the first disbursement of the Supplemental Allowance and continuing through the remainder of the Initial Term, provided that Tenant may pre-pay the Supplemental Allowance and interest accrued thereon at any time, without penalty, by at least 10 days’ prior written notice to Landlord.

(c) Latent Defect Costs . Landlord shall be responsible for the Latent Defect Costs, provided that Landlord may apply any Excess Base Building Allowance to the payment of Latent Defect Costs. Payment of Latent Defect Costs by Landlord shall be conditioned upon the subject Latent Defect Work having been performed in accordance with the provisions of this Lease, and shall be subject to Landlord’s receipt of a request for payment in form and with backup reasonably satisfactory to Landlord, including but not limited to such certifications, lien waivers and other documents from Tenant, Tenant’s contractor and Tenant’s Architect as Landlord may reasonably require (provided that lien waivers shall not be required from subcontractors performing work with an aggregate cost of less than $50,000 in any

 

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one instance). Tenant may request payment of Latent Defect Costs from time to time as the Latent Defect Work progresses, but not more frequently than monthly. Landlord shall pay or reimburse Tenant for Latent Defect Costs within 30 days after receipt of Tenant’s written request and reasonably satisfactory backup documentation. Landlord may inspect the Latent Defect Work as a condition to making any requested payment of Latent Defect Costs to confirm the status of the Latent Defect Work and that the Latent Defect Work is being performed in accordance with the provisions of this Lease.

(d) Latent Hazardous Materials Costs . Landlord shall be responsible for the Latent Hazardous Materials Costs, provided that Landlord may apply any Excess Base Building Allowance to the payment of Latent Hazardous Materials Costs.

(e) Offset Right . If Landlord shall fail to pay any amounts due with respect to the Base Building Allowance, the Space Planning Allowance, the TI Allowance, the Supplemental Allowance, or the Latent Defect Costs (such amounts being called “ Past Due Amounts ”), Tenant may offset the Past Due Amounts against Base Rent and Additional Rent only if Tenant first obtains (i) a judgment for recovery of the Past Due Amounts in a court of competent jurisdiction which is no longer subject to appeal, (ii) a determination that the Past Due Amounts are owing by Landlord in an arbitration conducted pursuant to the following provisions of this Section 3.5(e), or (iii) a written acknowledgment by Landlord that Landlord does not contest that the Past Due Amounts are owing. Any offset which Tenant is entitled to take pursuant to this Section 3.5(e) shall include interest on the Past Due Amounts from the due date at a per annum rate equal to 3% plus the prime rate of Bank of America (or any successor) in effect from time to time. Without limiting Tenant’s remedies for Landlord’s failure to pay any Past Due Amounts, Tenant may submit a claim for the Past Due Amounts to binding arbitration in accordance with the following provisions. Such arbitration shall be conducted by a single disinterested arbitrator having not less than ten years’ experience in the operation, maintenance and leasing of commercial real estate to be selected and held by the American Arbitration Association in Boston, Massachusetts in accordance with its expedited commercial rules and regulations then in effect. Landlord and Tenant shall use diligent good faith efforts to complete the arbitration within 30 days following the submission of the claim to arbitration. The determination of the arbitrator shall be conclusive upon the parties and judgment upon the same may be entered in any court having jurisdiction. The party which does not prevail in the arbitration as determined by the arbitrator shall pay for the arbitrator and related costs of the arbitration (but not the attorneys’ fees of the prevailing party). Except as provided in this Section 3.5(e), Tenant shall not have any right of offset with respect to amounts owing or claimed to be owing by Landlord to Tenant with respect to any Past Due Amounts.

Section 3.6 Landlord’s Specific Repairs . Landlord shall, at Landlord’s cost, perform the following maintenance and repairs prior to the Base Rent Commencement Date: (a) repair and point the steps and ramp on the parking lot side of the Building; (b) repair or replace the roof of the Building as necessary to prevent the current leaks; (c) repair or replace the glass in the exterior windows of the Building as necessary; (d) resolve the issue of snow falling onto the steps from the roof at the parking lot entrance of the Building; and (e) caulk the exterior edge and windows of the Building as necessary, in each case in a manner consistent with first class office and laboratory buildings. Landlord shall perform such work in a good and workmanlike manner, in accordance with all Legal Requirements, and in such a manner as to minimize interference with Tenant’s construction activities and Tenant’s use of the Premises, to the extent practical.

Section 3.7 Signs . Tenant may install or erect signage identifying Tenant’s business on the exterior of the Building and/or in the Outside Areas, subject to compliance with the following provisions of this Section 3.7. The location, design, shape, size, materials, color and type of such signs and all other matters related to such signage (other than Tenant’s right to erect such signage) shall be subject to Landlord’s prior written approval following submission by Tenant to Landlord of detailed plans and specifications therefor, which approval shall not be unreasonably withheld, conditioned or delayed. Tenant’s right to exterior signage shall be subject to compliance with all applicable requirements of the City of Cambridge, all other applicable Legal Requirements, and the Encumbrances. Tenant shall be solely responsible for confirming that any proposed sign is in compliance with all Legal Requirements. All costs of obtaining permits and approvals, creating, installing, illuminating, maintaining, repairing and/or

 

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replacing Tenant’s exterior signs shall be paid by Tenant. Any signs of Tenant located in the interior of the Building shall comply with all applicable Legal Requirements and may be installed and maintained by Tenant in its sole discretion. Tenant shall maintain its signs in good repair and condition. Upon the expiration of the Lease Term or other termination of this Lease, Tenant shall remove all of Tenant’s exterior signage from the Building and the Outside Areas and shall repair any damage caused by such signage or by the removal of such signage. Landlord shall cooperate with Tenant to obtain governmental approvals for any exterior signage in accordance with this Lease.

ARTICLE IV

BASE RENT; ADDITIONAL RENT

Section 4.1 Base Rent .

(a) Tenant shall pay Base Rent in the amounts set forth in Item 9 of the Summary of Basic Terms. Base Rent shall be payable in equal monthly installments of one-twelfth of the annual Base Rent then in effect and shall be paid without offset for any reason except as otherwise expressly provided herein, in advance, on the first day of each calendar month during the Lease Term. Base Rent and Additional Rent shall be paid by an “electronic funds transfer” system arranged by and among Tenant, Tenant’s bank and Landlord or otherwise by such method as is reasonably directed by Landlord upon at least 30 days’ prior notice to Tenant. The obligations owing by Tenant under this Section are rent reserved under this Lease, for all purposes hereunder, and are rent reserved within the meaning of Section 502(b)(6) of the Bankruptcy Code or any successor provision thereto.

(b) The Base Rent per square foot for each Extension Term will be 95% of the then fair market base rent per square foot for the Premises (the “ Market Rent ”), determined in accordance with Section 4.1(c) or Section 4.1(d); provided that in no event shall the Base Rent for an Extension Term be less than the Base Rent in effect at the end of the immediately preceding Initial Term or first Extension Term, as applicable. The Market Rent shall be determined as of the commencement of the applicable Extension Term at the then current arms-length negotiated rents being charged for comparable space in comparable buildings located in the market area of the Project, taking into consideration all relevant factors, including, without limitation, the treatment of Operating Costs and Taxes (e.g., if a comparable lease is on a so-called “gross” basis, then the portion of the rent reflecting Operating Costs and Taxes would be deducted from the comparable lease rents for purposes of determining Market Rent). The parties acknowledge that the Market Rent may or may not include escalations at various points during the Extension Term, depending upon market factors. The Market Rent for an Extension Term may be determined prior to exercise of the applicable extension option pursuant to Section 4.1(c). If Tenant exercises an extension option without the Market Rent for the applicable Extension Term having been determined pursuant to Section 4.1(c), then the Market Rent shall be determined pursuant to Section 4.1(d). Any communications, proposals, negotiations and agreements by the parties regarding the Market Rent shall be confidential information and shall be subject to the provisions of Section 13.14.

(c) At any time that Tenant has the right to exercise an extension option pursuant to Section 2.5(b), Tenant may, in anticipation of exercising such extension option, give Landlord a written notice requesting Landlord’s proposal as to the Market Rent. Within ten Business Days after receipt of such notice, Landlord shall give a written notice to Tenant with a good faith proposal as to the Market Rent. If Tenant does not accept such proposal in writing, then, at the request of Tenant, Landlord and Tenant shall negotiate in good faith to attempt to agree in writing upon the Market Rent prior to expiration of the time for Tenant to exercise the extension option pursuant to Section 2.5(b). If the parties agree in writing upon the Market Rent prior to expiration of the time for Tenant to exercise the extension option pursuant to Section 2.5(b) (which may consist of Tenant’s acceptance of Landlord’s good faith proposal, whether or not contained in Tenant’s notice of exercise of such extension option), then, if Tenant exercises such extension option, the Market Rent shall be as so agreed. Negotiation and agreement upon the Market Rent pursuant to this Section 4.1(c) shall not obligate Tenant to exercise the applicable extension option pursuant to Section 2.5(b). Nothing in this Section 4.1(c) shall extend the time for Tenant to exercise an extension option pursuant to Section 2.5(b).

 

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(d) (i) If Tenant gives Landlord written notice of exercise of an extension option pursuant to Section 2.5(b) without the Market Rent having been determined pursuant to Section 4.1(c), then, for a period of 15 days after Tenant gives Landlord such written notice (such period being called the “ Negotiation Period ”), Landlord and Tenant shall negotiate in good faith to attempt to agree upon the Market Rent. If the parties agree upon the Market Rent prior to the determination of the arbitrator pursuant to Section 4.1(d)(ii), whether such agreement is reached during or after the Negotiation Period, the Market Rent shall be as so agreed.

(ii) If the parties are unable to agree upon the Market Rent within the Negotiation Period, then each party shall, upon selection of an arbitrator pursuant to Section 4.1(d)(iii), simultaneously submit to the arbitrator for binding arbitration a proposal as to the Market Rent. The arbitrator shall not have the right to modify any provision of the Lease except Base Rent. Within 30 days after both parties have submitted such proposals to the arbitrator, the arbitrator shall select one of the proposals as more closely approximating the Market Rent appropriate for the Extension Term, and, unless the parties have then agreed upon the Market Rent, the proposed Market Rent set forth in such proposal selected by the arbitrator shall be deemed to be the Market Rent.

(iii) If the parties are unable to agree upon the Market Rent within the Negotiation Period, then the parties shall, within 15 days after the end of the Negotiation Period (such 15 day period being herein called the “ Selection Period ”), attempt to agree upon a qualified arbitrator (meeting the standards described below) to whom to submit the determination of Market Rent for binding arbitration pursuant to Section 4.1(d)(ii). If the parties are unable to agree upon a qualified arbitrator within the Selection Period, then, at the end of the Selection Period, each party shall select a qualified arbitrator and, within 15 days after the end of the Selection Period, the arbitrators shall agree upon a qualified arbitrator to whom the determination of Market Rent shall be submitted for binding arbitration pursuant to Section 4.1(d)(ii). If such arbitrators are unable to agree promptly upon a qualified arbitrator, a qualified arbitrator shall be selected by the Boston office of the American Arbitration Association. Any arbitrator selected by either party, by the arbitrators selected by the parties or by the American Arbitration Association shall be independent of both parties and shall have such experience, either as a licensed real estate broker or as an appraiser for at least ten years, as would qualify such arbitrator as an expert with respect to leasing terms for comparable buildings in the market area of the Project. Such arbitrator shall make the determination required pursuant to Section 4.1(d)(ii) within 30 days after selection. The parties shall share equally the fees and expenses of the arbitrator to whom the determination of Market Rent is submitted. Landlord and Tenant shall each pay the fee of the arbitrator selected by it.

Section 4.2 Certain Additional Rent . Tenant shall pay, without offset for any reason except as otherwise expressly provided herein, all payments of Additional Rent payable by Tenant to Landlord hereunder. If Tenant fails to pay any Additional Rent, Landlord shall have all the rights and remedies for failure to pay Base Rent. The obligations owing by Tenant under this Section are rent reserved under this Lease, for all purposes hereunder, and are rent reserved within the meaning of Section 502(b)(6) of the Bankruptcy Code or any successor provision thereto.

Section 4.3 Taxes .

(a) Tenant shall pay to Landlord, as Additional Rent, amounts equal to Tenant’s Share of the Taxes. The Taxes shall be estimated in good faith by Landlord at the commencement of the Lease Term and the end of each Tax Fiscal Year (based on the most recent tax data available to Landlord), and Tenant’s Share of the Taxes shall be payable to Landlord in equal estimated monthly installments on the first day of each calendar month during the Lease Term, subject to readjustment when the actual amount of Taxes is determined. After readjustment, any shortage shall be due and payable by Tenant within 30 days of demand by Landlord and any excess shall, unless an Event of Default has occurred, be credited against future Additional Rent obligations, or refunded if the Lease Term has ended and Tenant has no further obligations to Landlord. If the taxing authority provides an estimated tax bill, then monthly installments of Taxes shall be based thereon until the final tax bill is ascertained. Landlord shall furnish to Tenant promptly after receipt thereof a copy of the tax bill or any estimated tax bill for the Project received by Landlord.

 

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(b) If, after Tenant shall have made any payment under this Section, Landlord shall receive a refund (the “ Refund ”) of any portion of the Taxes paid on account of any Tax Fiscal Year in which such payments shall have been made as a result of an abatement of such Taxes, by final determination of legal proceedings, settlement or otherwise, Landlord shall, within 30 days after receiving the Refund, pay to Tenant (unless an Event of Default then exists) an amount equal to the lesser of (i) Tenant’s Tax payments for such Tax Fiscal Year or (ii) Tenant’s Share of the Refund, which payment to Tenant shall be appropriately adjusted if Tenant’s Tax payments covered a shorter period than covered by the Refund.

(c) Tenant’s obligation in respect of Taxes shall be prorated for the first and last Tax Fiscal Years within the Lease Term. If the final tax bill for the Tax Fiscal Year in which expiration or termination of this Lease occurs shall not have been received by Landlord, then within 30 days after the receipt of the tax bill for such Tax Fiscal Year, Landlord and Tenant shall make appropriate adjustments of estimated payments.

(d) Without limiting the generality of the foregoing, Tenant shall pay all rent and personal property taxes attributable to its signs or any other personal property including but not limited to its trade fixtures, the existing or any future floor coverings, wall treatments and light fixtures in the Premises.

(e) At Tenant’s request from time to time, Landlord shall promptly prosecute and diligently pursue an appeal or challenge of the assessed valuation of the Project or the amount of Taxes. Each of Landlord and Tenant shall cooperate as reasonably requested by the other in any such appeal or challenge. Tenant shall pay Additional Rent in respect of Taxes without regard to any appeal or challenge that might reduce the Taxes, until the determination of such appeal or challenge.

Section 4.4 Operating Costs .

(a) Tenant shall pay to Landlord, as Additional Rent, amounts equal to Tenant’s Share of the Operating Costs.

(b) Landlord shall furnish to Tenant no less than 30 days prior to the Commencement Date and prior to the beginning of each calendar year a budget of the estimated Operating Costs for the applicable calendar year (an “ Annual Budget ”), based on the most recent cost data available to Landlord. Landlord may, no more than one time during a calendar year covered by an Annual Budget, furnish to Tenant a revised Annual Budget based on updated cost data. Each Annual Budget and revised Annual Budget shall be subject to Tenant’s written approval, which Tenant will not unreasonably withhold, condition or delay. In any disapproval of an Annual Budget or revised Annual Budget, Tenant shall specify the reasons for disapproval and the changes suggested by Tenant. If Tenant fails to respond in writing to a proposed Annual Budget or revised Annual Budget within five Business Days after submission, and Landlord sends a subsequent notice requesting approval of such proposed Annual Budget or revised Annual Budget, including a copy of the same, stating conspicuously at or near the top of the first page, “FAILURE TO RESPOND TO THIS NOTICE WITHIN FIVE BUSINESS DAYS SHALL RESULT IN DEEMED CONSENT TO THE ANNUAL BUDGET”, and Tenant shall thereafter fail to respond in writing to such request within such second five Business Day period, such Annual Budget or revised Annual Budget shall be deemed approval by Tenant. The Additional Rent payable by Tenant in respect of Operating Costs shall not be limited by any Annual Budget or revised Annual Budget, provided that Landlord uses commercially reasonable efforts, in good faith, to keep Operating Costs within the Annual Budget.

(c) Tenant’s Share of the Operating Costs shall be payable in equal estimated monthly installments on the basis of the Annual Budget on the first day of each calendar month during the Lease Term, subject to readjustment on no more than on occasion in each calendar year on the basis of any revision of the Annual Budget and also when actual Operating Costs are determined as further provided in Section 4.6. After a readjustment, any shortage shall be due and payable by Tenant within 30 days of demand by Landlord and any excess shall, unless an Event of Default then exists, be credited against future Additional Rent obligations, or refunded promptly if the Lease Term has ended and Tenant has no further obligations to Landlord.

 

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(d) Landlord shall bid any contracts for third party services that would be included in Operating Costs and cost more than $35,000 per year to at least three qualified bidders. Contracts for such services shall be limited to one-year terms unless otherwise approved by Tenant. Tenant shall have the right to propose one or more qualified bidders reasonably approved by Landlord for any such services. Landlord shall (i) consult with Tenant from time to time as reasonably requested by Tenant regarding Operating Costs and appropriate actions to reduce or control Operating Costs consistent with the operation of a first-class office building, and (ii) furnish such information as Tenant may reasonably request from time to time regarding Taxes and Operating Costs. Landlord will consider in good faith suggestions made by Tenant to reduce or control Operating Costs and will not unreasonably refuse to act on such suggestions. Unless required by Legal Requirements (but excluding Legal Requirements to which Landlord voluntarily submits by contract, such as agreements entered into between Landlord and the City of Cambridge), Landlord will not initiate any shuttle or other transportation service serving the Project, the cost of which would be included in Operating Costs, without Tenant’s consent. Other than where impractical by reason of an emergency, Landlord shall, prior to incurring any Permitted Capital Operating Costs which Landlord anticipates will cost in excess of $10,000, give Tenant written notice of the subject capital repair, replacement or improvement, including the anticipated cost thereof.

Section 4.5 Utility Costs . Tenant shall promptly pay all Utility Costs when due to the appropriate public utility. Landlord shall cooperate with Tenant to place all utilities for the Project in Tenant’s name on the Commencement Date or as soon thereafter as practicable. Until such time as any utilities are placed in Tenant’s name, Tenant shall pay such costs directly to the provider within 30 days following receipt of actual provider bills therefor from Landlord.

Section 4.6 Tenant’s Audit Rights . Annually, within three months after the end of each calendar year (or, with respect to Taxes, Tax Fiscal Year), Landlord shall furnish to Tenant a report setting forth in reasonable detail the Operating Costs (reconciled to the Annual Budget) and Taxes for the immediately preceding calendar year (in the case of Operating Costs ) or Tax Fiscal Year (in the case of Taxes). Tenant shall have the right to audit Landlord’s books and records relating to Operating Costs and/or Taxes with respect to the period covered by each such report within one year after receipt of such report (such one year period being called the “ Audit Period ”) by delivering a notice of its intention to perform such audit to Landlord. If, as a result of such audit, Tenant believes that it is entitled to receive a refund of any Additional Rent paid by Tenant in respect of Operating Costs and/or Taxes, Tenant shall deliver to Landlord, no later than the later to occur of 30 days after expiration of the Audit Period or 150 days after Landlord makes available such books and records to Tenant at a location in the Greater Boston area, a notice demanding such a refund, together with a statement of the grounds for each such demand and the amount of each proposed refund. Notwithstanding anything to the contrary herein, if any line item in the annual statement of Operating Costs and Taxes is overstated by more than 10%, then Tenant shall have the right to audit Landlord’s books and record with respect to such line item (but not other matters) for an additional two year period prior to the year already under review. The cost of any such audit shall be paid by Tenant, except that, if it is established that the Additional Rent in respect of Operating Costs and Taxes charged to Tenant for the period in question was overstated by more than 3%, the reasonable out-of-pocket cost of such audit paid to a third party other than an employee of Tenant, up to a maximum of $10,000, shall be paid or reimbursed to Tenant by Landlord. An overstatement shall not be deemed to exist due to a Refund. Any audit shall be performed by either (a) Tenant’s regular employees or (b) a reputable certified public accountant reasonably acceptable to Landlord whose compensation is not, directly or indirectly, contingent in whole or in part on the results of the audit. If Landlord determines that a report previously furnished by Landlord was in error, Landlord may furnish a corrective or supplemental report to Tenant within one year after the original report was furnished, and if such corrective or supplemental report results in increased Additional Rent, the Audit Period for the year covered by such report shall be extended for one year after Landlord furnishes the corrective or supplemental report. Tenant’s rights under this Section 4.6 shall survive the termination of this Lease.

 

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ARTICLE V

USE OF PREMISES

Section 5.1 Permitted Use . Tenant shall use and occupy the Premises only for the Permitted Use.

Section 5.2 Restrictions on Use . Tenant shall use the Premises in a careful, safe and proper manner, shall not commit or suffer any physical waste on or about the Project, and shall not make any use of the Project which is prohibited by or contrary to any Legal Requirements, or which would cause a public or private nuisance. In addition, Tenant shall comply with the Declaration in Tenant’s use and occupancy of the Premises. Tenant, at its own expense, shall obtain any and all permits, approvals and licenses necessary for Tenant’s particular use of the Premises (as opposed to general office use generally). Tenant shall not overload the floors or other structural parts of the Building, based on the actual floor load of the Building; and shall not commit or permit anyone claiming by through or under Tenant to commit any act or thing on the Project which violates Legal Requirements (subject to Tenant’s rights pursuant to Section 7.7). Tenant shall not do or permit to be done any act or thing on the Project which will invalidate or be in conflict with the reasonable requirements of any insurance policies made known to Tenant, or which will increase the rate of any insurance, covering the Building (unless Tenant agrees to pay the same). Tenant shall cause any fire lanes located within the Project to be kept free of all parking associated with its business or occupancy. Tenant shall not permit the emission of any objectionable noise or odor from the Premises in a manner that is inconsistent with first class office use and shall at its own cost install such extra sound-proofing or noise control systems and odor control systems, as may be needed to eliminate noise, vibrations and odors, if any, emanating from the Premises being heard, felt or smelled outside the Premises. Tenant shall not permanently place any file cabinets bookcases, partitions, shelves or other furnishings or equipment in a location which blocks any windows (temporary location in such a manner shall be permitted where required to accommodate on-going Alterations or a de minimis number of temporary offices).

Section 5.3 Hazardous Materials .

(a) Tenant (i) will not conduct any activity on the Premises that will use or produce any Hazardous Materials, except for such activities that are both (1) part of the ordinary course of Tenant’s business activities and (2) conducted in accordance with all Environmental Laws; (ii) will not use the Premises in any manner for the storage of any Hazardous Materials except for storage of such materials that are both (1) used in the ordinary course of Tenant’s business and (2) properly stored in a manner and location satisfying all Environmental Laws; (iii) will not install any underground tanks of any type; and (iv) will not permit any Hazardous Materials to be brought onto the Premises, except in the ordinary course of Tenant’s business and in compliance with all Environmental Laws. If any Hazardous Materials are brought or found on the Premises in violation of the above provisions of this Section, the same shall be immediately removed by Tenant, with proper disposal, and all required cleanup procedures shall be diligently undertaken pursuant to all Environmental Laws. If at any time during or after the Lease Term the Premises are found to be so contaminated or subject to such conditions as a result of Tenant’s failure to comply with the foregoing provisions, Tenant shall defend, indemnify and hold Landlord harmless from all claims, demands, actions, liabilities, costs, expenses, damages and obligations of any nature arising from or as a result of such failure. Tenant will maintain on the Premises a list of all materials stored at the Premises for which a material safety data sheet (an “ MSDS ”) was issued by the producers or manufacturers thereof, together with copies of the MSDS’s for such materials, and shall deliver such list and MSDS copies to Landlord upon Landlord’s request therefor. Tenant shall remove all Hazardous Materials existing in or on the Premises as a result of the activities of Tenant or any of Tenant’s Invitees in a manner acceptable to Landlord before the earlier of the date Tenant vacates the Premises and the date Tenant’s right to possess the Premises ends. Landlord may, subject to the provisions of Section 7.10, enter the Premises and conduct environmental inspections and tests therein as it may require from time to time, provided that Landlord shall use reasonable efforts to minimize the interference with Tenant’s business and shall provide Tenant with a copy of any final reports from such inspections and tests, and provided further than any invasive inspections and tests shall be subject to the immediately following sentence. Such environmental inspections may include invasive work so long as

 

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(a) Landlord has a good faith reason to believe that invasive work is necessary to identify Hazardous Materials conditions in violation of law, based on observed or known conditions, (b) Landlord consults with Tenant regarding the scope and necessity for such invasive work prior to undertaking the same, (c) any damage caused by such invasive work is promptly repaired by Landlord at its sole cost and expense, (d) any invasive work is carried out after regular business hours and with all measures reasonably taken to avoid damaging property of Tenant, and (d) Landlord obtains split samples of any materials that are tested and provides Tenant with such materials so that Tenant can conduct its own inspection and tests. Such inspections and tests shall be conducted at Landlord’s expense, unless they reveal the presence of Hazardous Materials in violation of the above provisions of this Section or that Tenant has not complied with the requirements of this Section, in which case Tenant shall reimburse Landlord for the reasonable out-of-pocket cost thereof within 30 days after Landlord’s request therefor to the extent resulting from Tenant’s violation of the above provisions.

(b) Landlord represents to Tenant that (a) attached hereto as Schedule 5.3 is a list of all third party environmental reports in Landlord’s possession or control with respect to the Project, copies of which have been provided to Tenant , and (b) except as disclosed in such reports, Landlord does not have actual knowledge of the existence of any Hazardous Materials at the Project in violation of Environmental Laws as of the date of this Lease. Landlord will indemnify, defend and hold Tenant harmless from and against any and all liabilities, claims, costs and expenses arising from the existence of Hazardous Materials at the Project in violation of Environmental Laws as of the date of this Lease or caused by or through Landlord (whether before or after the date of this Lease), except to the extent resulting from the activities of Tenant or any of Tenant’s Invitees.

Section 5.4 ADA . Landlord represents to Tenant that Landlord does not have actual knowledge of any non-compliance of the Project with the Americans with Disabilities Act or other applicable Legal Requirements (without regard for Tenant’s particular use of the Premises, as opposed to office use generally). For purposes of Sections 5.3 and 5.4 of this Lease, “actual knowledge” means the actual knowledge of Eric Schlager, Robert Schlager, James Cronin or Tim DiGaetano.

Section 5.5 Outside Equipment . At no additional rent to Tenant, but otherwise at Tenant’s cost, Tenant shall have the right to install and maintain Outside Equipment on the roof of the Building and/or on the Land for Tenant’s use in connection with Tenant’s business (provided that Tenant shall not be permitted to make any alterations or installations that, in Landlord’s reasonable judgment, could invalidate or otherwise adversely affect any roof warranty, a copy of which has been provided to Tenant), subject to (a) Legal Requirements, (b) the terms and conditions of this Lease (including, but not limited to, Section 5.2 and Article VII), (c) the Encumbrances, and (d) Landlord’s written approval (not to be unreasonably withheld, conditioned or delayed) of the size and location of such Outside Equipment, together with the plans and specifications therefor. Landlord may condition Landlord’s approval of any Outside Equipment on Tenant’s agreement to remove such Outside Equipment at the end of the Lease Term; otherwise, Tenant will have no obligation to remove any Outside Equipment approved by Landlord at the end of the Lease Term. Tenant shall have access to the roof of the Building for the purpose of installing, using, maintaining, repairing and replacing any Outside Equipment to be located on the roof, subject to Landlord’s reasonable requirements. Tenant shall not allow any third parties, other than affiliates of Tenant and permitted subtenants and assignees, to use any Outside Equipment installed by Tenant.

ARTICLE VI

SERVICES

Section 6.1 Landlord’s Services . Landlord shall furnish to the Project the services set forth below in this Section 6.1 (the “ Services ”), other than any Tenant-Assumed Services. The Services consist of the following, all of which shall be provided in a manner consistent with the operation of the Project as a Class A office property in the Boston metropolitan area:

(a) Building . Maintaining, repairing and replacing, as necessary, and keeping in good condition the exterior and structure of the Building and mechanical elements and building systems of the Building, including the exterior windows and glass, the roof and roof system and structure, façade, floor slabs, load-bearing walls, columns, foundation, and the utility lines and systems (including the sump pump and related basement drainage) serving the Building.

 

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(b) Systems . Operating, maintaining, repairing and replacing as necessary the heating, ventilating and air conditioning system, the plumbing system, the life safety and building management system, the elevators and mechanical systems and the electrical system of the Building in accordance with the specifications set forth in Schedule 6.1(b) hereto, and keeping the same in good operating order and condition on a 24-hour, 7-day a week basis.

(c) Water and Sewer . Providing cold and hot water for ordinary drinking, cleaning, sanitary and lavatory purposes and water as required to serve the Building systems on a 24-hour, 7-day a week basis.

(d) Outside Areas . Maintaining and repairing, and providing lighting and landscaping, for the Outside Areas; including snow and ice removal and striping and repaving the parking areas and drives, if any.

(e) Waste Removal . Arranging for waste removal services for the Building.

(f) Janitorial Services . Providing janitorial services for the Premises in accordance with the janitorial schedule set forth in Schedule 6.1(f) hereto or another janitorial schedule specified by Tenant and reasonably satisfactory to Landlord.

(g) Taxes . Paying all Taxes levied upon or with respect to the Project.

(h) Insurance . Procuring and maintaining in full force and effect the following insurance coverages:

 

  (i) Commercial General Liability Coverage with respect to the Project, and the conduct and operation of its business therein, including coverage for premises and operations, personal and advertising injury, products and completed operations, independent contractors and blanket contractual liability, and carrying the same coverages and same minimum limits required to be carried by Tenant;

 

  (ii) Cause of Loss-Special Form property insurance, including boiler and machinery coverage (in an amount equal to 100% of the replacements costs of the equipment) with respect to the Building, its fixtures, equipment and personal property, the Base Building Work on an occurrence basis with a 100% Replacement Cost basis of valuation, with an agreed amount endorsement waiving all co-insurance provisions, and a deductible not in excess of commercially reasonable deductibles then being carried by institutional landlords of comparable buildings and covering at least the following perils: building collapse, fire, hurricane, impact of vehicles and aircraft, lightning, malicious mischief, earth movement, subsidence, terrorism (to the extent available and carried by owners of comparable buildings generally), theft, vandalism, sprinkler leakage, water damage and windstorm. Such coverage shall include an Ordinance or Law Coverage Endorsement, and commercially reasonable limits of Wind/Hail coverage and shall insure costs of demolition;

 

  (iii) Business income/rental income insurance (including off-premises services coverage ) in an amount sufficient to cover twelve (12) months’ of loss of business income and rents;

 

  (iv) Workers’ compensation insurance in accordance with applicable Legal Requirements and Employer’s Liability insurance in amounts and with deductibles comparable to the insurance being carried by comparable owners, provided, however, to the extent Landlord does not have employees, Landlord shall cause the property management company for the Building to maintain such coverages with respect to its employees; and

 

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  (v) Such other insurance coverages or amounts of property or liability coverages as are required by its mortgagees or that Landlord reasonably determines to be prudent and consistent with coverages carried by owners of comparable buildings.

(i) Access . Landlord shall provide Tenant with 24 hour, 7-day per week access to the Premises and Project.

(j) Flood Management . Flood and storm water management measures consistent with first class office buildings in locations comparable to the Project.

(k) Compliance with Laws . Landlord shall cause the Project to comply with all applicable Legal Requirements, including without limitation, the regulations and accessibility guidelines issued pursuant to the Americans With Disabilities Act (42 U.S.C. §12101 et. seq.) to the extent that the same are applicable to the Building and with any and all directions, rules and regulations of Boards of Fire Underwriters, Rating Boards or the like (or successor agencies), provided that (i) Tenant, rather than Landlord, shall be responsible for the performance of the Base Building Work and TI Work (but, upon completion of the Base Building Work, Tenant shall assign all contracts and warranties for the Base Building Work to Tenant as provided in Section 3.1(e) and Landlord shall thereafter be responsible for ongoing maintenance and repair of the Base Building Work as provided in Section 3.1(e) and compliance of such Base Building Work with Legal Requirements), and (ii) nothing shall obligate Landlord to cause the Project to comply with applicable Legal Requirements to the extent such need for compliance results from Tenant’s particular use of the Premises, as opposed to general office use, generally.

(l) Other . Any other services necessary or appropriate for the management and operation of the Project as a “Class A” office property in the Boston metropolitan area. Landlord shall cooperate with Tenant to establish a protocol for Tenant to obtain services through Landlord’s contractors directly where necessary and appropriate (e.g. emergencies, day-to-day services for which prior written notice is cumbersome).

(m) Change in Service Providers . If Tenant gives Landlord written notice (a) that Tenant is dissatisfied with the performance of any service provider retained by Landlord, (b) stating the reasons for Tenant’s dissatisfaction, and (c) that Tenant desires that such provider be replaced, then, provided that the reasons stated for Tenant’s dissatisfaction are not arbitrary, Landlord shall use commercially reasonable efforts to replace the provider.

Section 6.2 Tenant-Assumed Services .

(a) Tenant shall have the option, exercisable from time to time by not less than 30 days’ prior written notice given to Landlord at any time that an Event of Default does not exist, to assume responsibility for any of the Services specifically identified in such notice as of the date specified in such notice; provided that Tenant may not assume responsibility for the Services described in Section 6.1(g) (payment of Taxes) or Section 6.1(h) (insurance to be maintained by Landlord). Any Service for which Tenant assumes responsibility as provided above shall, from the effective date of such assumption until the relinquishing of such responsibility by Tenant or the recapturing of such responsibility by Landlord as provided below, be called a “ Tenant-Assumed Service .” Tenant may, by not less than 30 days’ prior written notice to Landlord, relinquish responsibility for any Tenant-Assumed Service specified in such notice as of the date specified in such notice. At any time that an Event of Default exists, Landlord may, by written notice to Tenant, recapture any Tenant-Assumed Service specified in such notice as of the date specified in such notice. Landlord and Tenant shall confer from time to time as requested by either to discuss the allocation of Services as between Landlord’s Services the Tenant-Assumed Services.

(b) Tenant shall perform each Tenant-Assumed Service directly or through a contractor approved by Landlord, which approval Landlord will not unreasonably withhold, condition or delay. Tenant shall perform or cause each Tenant-Assumed Service to be performed in a good and workmanlike manner, in accordance with all Legal Requirements, in accordance with any applicable provisions of the Declaration, and consistently with the operation of a “Class A” office property in the

 

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Boston metropolitan area. If any Tenant-Assumed Service is not performed as required above, Landlord may, in addition to any other remedies available to Landlord, after written notice to Tenant and a reasonable opportunity to cure, require Tenant to replace the contractor performing such Tenant-Assumed Service with another contractor in accordance with the above provisions of this Section or to cease self-performing such Tenant-Assumed Service (if Tenant has elected to do so) and to engage a contractor to perform such Tenant-Assumed Service in accordance with the above provisions of this Section.

Section 6.3 Interruption .

(a) Except as otherwise provided in this Lease, Tenant shall not be entitled to any abatement of Base Rent or Additional Rent, nor shall Landlord have any liability to Tenant, nor shall this Lease or any of Tenant’s obligations hereunder be affected, by reason of a stoppage or interruption of utility services caused by breakage, accident, strikes, repairs, or for any other cause or causes beyond the reasonable control of Landlord, provided that Landlord shall use reasonable efforts to minimize the effect of any such stoppage or interruption and to eliminate the same at the earliest practicable time.

(b) As used herein, an “ Occupancy Interruption ” shall have occurred if: (1) Tenant is unable to use any portion of the Premises for the Permitted Use due to any reason other than (i) any act or neglect of Tenant or Tenant’s Invitees, (ii) the failure by Tenant to perform Tenant’s obligations under this Lease, or (iii) fire or other casualty or condemnation (which events shall be governed by the provisions of Articles X and XI, as applicable), and (2) Tenant shall have given written notice to Landlord of such Occupancy Interruption (a “ Tenant Interruption Notice ”). If an Occupancy Interruption occurs and continues for a period of five (5) consecutive Business Days, Base Rent and Additional Rent shall be abated based on the extent of the inability to use the Premises from and after the 6 th consecutive Business Day until such Occupancy Interruption is ended. Within five Business Days after Landlord’s receipt of any Tenant Interruption Notice, Landlord shall reasonably estimate the date by which such Occupancy Interruption will end and provide written notice of such estimate to Tenant. If (x) Tenant is unable to use 25% or more of the Premises for the Permitted Use by reason of an Occupancy Interruption, and (y) Landlord reasonably estimates that such Occupancy Interruption will not end within 180 days after Tenant gives the subject Tenant Interruption Notice, or if such Occupancy Interruption occurs during the last year of the Lease Term (taking into account any extension option then exercised by Tenant) and Landlord reasonably estimates that such Occupancy Interruption will not end within 45 days after Tenant gave the subject Tenant Interruption Notice, then Tenant shall have the right to terminate this Lease by notice to Landlord given within 30 days after receipt of Landlord’s estimate. Notwithstanding anything herein to the contrary, in the event this Lease is not terminated as provided for above and the Occupancy Interruption does not end within 60 days from the date by which Landlord estimated it would end, then Tenant shall have the right to terminate this Lease by notice to Landlord given prior to the end of the Occupancy Interruption. Where Tenant is terminating this Lease pursuant to this Section 6.3(b), such termination shall be effective as of the date for termination set forth in Tenant’s termination notice, which date shall not be later than 60 days after the date of such notice.

Section 6.4 Additional Services . If Tenant requests Landlord to perform any service other than Landlord’s Services, Landlord shall, before performing such service, give Tenant an estimate of the cost of performing such service, and if Tenant elects to have Landlord perform such service, Tenant shall pay to Landlord as Additional Rent therefor Landlord’s actual costs for providing such service, plus an additional 15% of such cost as an administrative fee, within 30 days of Landlord’s billing Tenant therefor. Landlord has no obligation to provide any such service and Tenant has no obligation to use Landlord to perform any such service.

Section 6.5 Declaration . Landlord represents to Tenant that the Declaration is in full force and effect and has not been amended (except as set forth in the definition of Declaration) and, to the actual knowledge of Landlord, Landlord is not in default in the performance of its obligations under the Declaration. Landlord shall maintain the Declaration in full force and effect throughout the term of the Lease. As one of the Lease Effectiveness Conditions, Landlord will obtain and furnish to Tenant an estoppel certificate executed by Parcel B Owner substantially in the form of Schedule 6.5 hereto or in

 

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such other form as is reasonably satisfactory to Tenant. On or about the Commencement Date, Landlord shall give Parcel B Owner a notice in the form of Exhibit F hereto, designating Tenant as a “Parcel A Parking Tenant,” as defined in the Declaration, with respect to 105 parking spaces or such smaller number of parking spaces which Tenant has indicated by written notice to Landlord that Tenant desires to use, and designating Tenant as a “Parcel A Designated Tenant,” as defined in the Declaration. Landlord shall duly and punctually pay and perform Landlord’s obligations under the Declaration, subject to the payment and performance of Tenant’s obligations with respect to the same, as necessary to preserve the rights of the Project and occupants thereof under the Declaration. Other than with the prior written consent of Tenant, Landlord will not agree to any amendment of the Declaration or take any action, or grant any consent, under the Declaration (including the promulgation of rules and regulations pursuant to Section 4.5 of the Declaration) (other than actions that Landlord is obligated to undertake as the Parcel B Owner such as payments of costs due under the Declaration), if such amendment, consent or action would have an adverse effect on the rights or obligations of Tenant under this Lease (including any action that would increase Operating Costs or impact the cost of parking thereunder). To the extent that Landlord’s consent or approval under the Declaration may not be unreasonably withheld, conditioned or delayed under the express terms of the Declaration, Tenant agrees that the same standard applies to its obligations with respect to consents under the immediately preceding sentence. Landlord shall timely enforce the terms of the Declaration against the Parcel B Owner in the event that the Parcel B Owner is not in compliance with the Declaration. Any amounts paid by the Parcel B Owner pursuant to Section 12.2.2 of the Declaration shall be paid by Landlord to Tenant upon receipt.

Section 6.6 Landlord Indemnity . Subject to Section 13.5 and Section 12.8, Landlord will exonerate, indemnify, defend, save and hold harmless Tenant (and any and all Persons claiming by, through or under Tenant) from and against all claims, proceedings, defenses thereof, liabilities, costs, and expenses of any kind and nature, including reasonable legal fees, arising from any negligent act or omission of any of Landlord’s Invitees, or arising from any accident or injury to third persons or damage to property of third persons to the extent caused by the negligence or willful misconduct of Landlord or Landlord’s Invitees, except to the extent resulting from the negligence or willful misconduct of Tenant or any of Tenant’s Invitees. This exoneration, indemnification and hold harmless agreement shall survive the termination of this Lease.

ARTICLE VII

CERTAIN OBLIGATIONS OF TENANT

Section 7.1 Rent . Tenant will promptly pay the Base Rent and Additional Rent, including without limitation any and all fees, charges, expenses, fines, assessments or other sums payable by Tenant to Landlord (or to the applicable provider of utilities) at the time and in the manner provided for in this Lease, all of which shall be deemed to be obligations to pay Base Rent or Additional Rent.

Section 7.2 Utilities . Tenant’s use of electric current shall never exceed the capacity of existing feeders, risers and wiring installations in the Building as set forth on Schedule 6.1(b) . Without limiting the foregoing, Tenant shall not connect to the electrical distribution system anything other than normal office equipment (other than Tenant’s Outside Equipment) Tenant shall not make or perform any alterations to wiring, installations, lighting fixtures or other electrical facilities in any manner without the prior written consent of Landlord in accordance with Article VII. Any risers or wiring to meet Tenant’s excess electrical requirements, if requested by Tenant and approved by Landlord, will be installed by Tenant at Tenant’s expense.

Section 7.3 No Waste . Tenant shall not overload, damage or deface the Premises nor shall it suffer or permit the same to be done by anyone claiming by, through or under Tenant, nor shall it commit any physical waste of the Project.

 

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Section 7.4 Maintenance; Repairs; and Yield-Up .

(a) During the Lease Term and any holdover, Tenant will keep the Premises neat and clean and maintain the same in the condition in which it is delivered to Tenant or such better condition as it may be put in thereafter in connection with any Alterations, subject to Landlord’s obligations pursuant to Section 6.1. Tenant’s obligation to so maintain and repair the Premises shall apply to all of the Premises, excluding such elements which are to be maintained and repaired by Landlord as part of Landlord’s Services. At the end of the Lease Term or sooner termination of this Lease, Tenant shall peaceably surrender and deliver up the Premises to Landlord, broom clean, with all utilities safely capped or connected to applicable fixtures, and in the condition Tenant is required to maintain the same hereunder (reasonable wear and tear excepted), and removing all signs and lettering identifying Tenant and all personal property, goods and effects belonging to Tenant or anyone claiming through or under Tenant. The Base Building Work and the TI Work shall be the property of Landlord and shall remain upon, and be surrendered with, the Premises at the end of the Lease Term or sooner termination of this Lease. Tenant shall cause all maintenance and repair work which is the responsibility of Tenant to conform to Legal Requirements. Tenant shall keep the Premises reasonably clear of all filth, trash and refuse. If Tenant fails to perform Tenant’s obligations under the above provisions of this Section beyond applicable notice and cure periods, then Landlord will have the right (but not the obligation), without waiving any default by Tenant, to cause such obligations to be performed upon not less than five Business Days prior written notice to Tenant (or a shorter period of prior written notice, or a contemporaneous written notice, if necessary to prevent harm to persons or property), and if Landlord causes any of such obligations to be performed, the out of pocket costs and expenses reasonably incurred by Landlord in connection therewith shall be due and payable by Tenant to Landlord as Additional Rent within 10 days following demand.

(b) Tenant shall keep any and all Outside Equipment neat and reasonably clean and maintain any and all Outside Equipment in good repair and condition. If, as a condition of approving any Outside Equipment, Landlord required Tenant to remove such Outside Equipment at the end of the Lease Term, then, at the end of the Lease Term or sooner termination of this Lease, Tenant shall, at Tenant’s cost, remove the Outside Equipment. Tenant shall repair any and all damage to the roof and other parts of the Building resulting from the removal of any Outside Equipment and restore the roof and other parts of the Building affected by any removed Outside Equipment to the same condition as existed prior to the installation of such Outside Equipment.

Section 7.5 Alterations by Tenant . Except for Permitted Alterations, as further described below, Tenant will not make any alteration, improvement or addition to the Premises (any such alterations, improvements or additions, including the Base Building Work and the TI Work, being called, “ Alterations ”) without first obtaining, on each occasion, Landlord’s consent in writing as provided below (which consent shall not be unreasonably withheld, conditioned or delayed), and then only at Tenant’s expense (other than as provided in Section 3.5), and in a lawful manner. In connection any Alterations, Tenant shall (a) provide Landlord with evidence of insurance in form and substance reasonably satisfactory to Landlord, and (b) comply with Sections 7.9 and 7.11. Notwithstanding the foregoing, Tenant may, upon prior written notice to, but without the requirement of consent by, Landlord, make the following Alterations (“ Permitted Alterations ”): (i) Alterations which (1) are non-structural, (2) do not penetrate or otherwise affect the roof or exterior of the Building, (3) do not materially adversely affect any Building system, and (4) are not reasonably anticipated to cost more than $250,000 in any single instance or related instances; (ii) Alterations which are purely cosmetic in nature, such as paint, wallcovering, carpeting and the like, regardless of cost; and (iii) subject to the provisions of Sections 3.1 and 3.2, above, the Base Building Work and TI Work. Any Alteration shall be consistent with the Permitted Use and with the nature of the Building and shall be made only after duly obtaining (and providing to Landlord copies of) all required permits and licenses from all governmental authorities. Tenant will deliver to Landlord in writing a schedule setting forth the details and location of all proposed Alterations and, to the extent a building permit is required for such Alterations, reasonably detailed plans and specifications. The contractor(s) performing the work other than Permitted Alterations shall be subject to Landlord’s approval, which will not be unreasonably withheld, conditioned or delayed. If required by Landlord’s lender, Tenant shall, at Landlord’s cost, provide a statutory lien bond with respect to Alterations (but such bond shall not be a condition to the approval of Alterations or to the commencement or prosecution of the same). All approved Alterations and all Permitted Alterations made by Tenant shall be made in a good and workmanlike manner in accordance with Legal Requirements, and, to the extent applicable, substantially in accordance with plans and specifications approved by Landlord. Landlord may condition Landlord’s

 

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approval of specialty Alterations (that is, Alterations for Tenant’s specific use that are not useful for office purposes generally) on Tenant’s agreement to remove such Alterations at the end of the Lease Term; otherwise, Tenant will have no obligation to remove any Permitted Alterations or Alterations approved by Landlord at the end of the Lease Term. Except to the extent that Landlord requires the removal of specialty Alterations as a condition of approval, all Alterations shall be the property of Landlord and shall remain upon, and be surrendered with, the Premises at the end of the Lease Term or sooner termination of this Lease. Notwithstanding the foregoing to the contrary, Tenant shall retain the exclusive right to depreciation for all Alterations made by Tenant, but not the right to depreciation for the TI Costs to the extent of the TI Allowance). Subject to the above provisions of this Section 7.5, Alterations may include security systems, kitchen and cafeteria facilities consistent with first class office use, installation of data cabling and pedestrian walkways (covered or uncovered) between the Building and Tenant’s premises in other adjacent buildings, lobby modifications, restrooms, and a fitness facility.

If Landlord fails to respond to Tenant within 10 Business Days after receipt of a Tenant request for approval of any Alterations under this Lease, then Tenant may give Landlord a follow-up notice demanding a response to the request, which follow-up notice shall state conspicuously at or near the top of the first page, “THIS IS A FOLLOW-UP NOTICE REQUESTING YOUR CONSENT TO ALTERATIONS BY INFINITY PHARMACEUTICALS, INC. YOUR FAILURE TO RESPOND IN WRITING TO THIS FOLLOW-UP NOTICE WITHIN FIVE BUSINESS DAYS SHALL BE DEEMED TO CONSTITUTE CONSENT.” Within five Business Days after receipt of such a follow-up notice, Landlord shall give written notice to Tenant consenting or withholding consent to the proposed Alterations, and if Landlord fails to give such a written notice within such five Business Day period, Landlord shall be deemed to have consented to the proposed Alterations.

Landlord shall not charge a supervisory or management fee for any Alterations, the TI Work or the Base Building Work.

Section 7.6 Trade Fixtures and Equipment . Any trade fixtures installed in, or attached to, the Premises by, and at the expense of, Tenant, and any Outside Equipment, shall remain the property of Tenant, if the same may be removed without damage to, or destruction of, the Premises. Tenant shall have the right, at any time and from time to time during the Lease Term, to remove any and all of its trade fixtures which it may have installed in, or attached to, the Premises, during the Lease Term, and any Outside Equipment. In addition, at the end of the Lease Term or sooner termination of this Lease, Tenant shall remove all of Tenant’s trade fixtures and, if Landlord required Tenant to remove any Outside Equipment as a condition of approving such Outside Equipment, such Outside Equipment. At any time that Tenant removes any of its trade fixtures or Outside Equipment, Tenant shall promptly repair any damage to the Project caused by such removal.

Section 7.7 Compliance with Laws . Tenant, in its use of the Premises and at its sole expense, shall comply with all applicable Legal Requirements, including, without limitation, all Legal Requirements related to the use, storage, discharge, release, removal or existence of Hazardous Materials. Tenant shall keep the Premises in a sanitary and safe condition in accordance with all applicable Legal Requirements. The above provisions of this Section 7.7 are subject to Landlord’s obligations under Section 6.1. Notwithstanding anything in this Section 7.7 to the contrary, Tenant shall have no obligation to make any structural repairs or replacements or undertake any repairs or maintenance to the extent the responsibility of Landlord under this Lease except to the extent resulting from Tenant’s particular use or occupancy of the Premises, as distinguished from general office use, generally (e.g. including by the construction of Alterations, but excepting the Base Building Work).

Tenant may, at its expense, contest the validity or applicability of any Legal Requirements by appropriate proceedings prosecuted diligently and in good faith (including, but not limited to, the right to apply for and obtain a waiver or deferment of compliance, the right to assert any and all defenses allowed by applicable Legal Requirements and the right to appeal any decisions, judgments or rulings to the fullest extent permitted by applicable Legal Requirements), and may defer compliance therewith, provided that Landlord is not thereby subjected to actual or potential criminal prosecution, criminal or civil penalty or civil liability and such actions by Tenant do not otherwise have a material adverse effect on Landlord or the Project.

 

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Section 7.8 Contents at Tenant’s Risk . All inventory, equipment, goods, merchandise, furniture, fixtures and property of every kind which may be on or about the Premises, and all Outside Equipment, shall be at the sole risk and hazard of Tenant, and if the whole or any part thereof shall be destroyed or damaged by fire, water or otherwise, or by the use or abuse of water or by the leaking or bursting of water pipes, or by rising water, or by roof or other structural leak, or by loss of electrical service, or in any other way or manner, no part of such loss or damage shall be charged to or borne by Landlord in any case whatsoever, except that the foregoing shall not exculpate the Landlord from its own negligent or willful acts or omissions. Tenant shall maintain full and adequate insurance coverage on all of its property at the Premises, including physical damage, theft and business interruption insurance, or Tenant shall be a self-insurer thereof, in which case Tenant shall so advise Landlord in writing and shall be fully responsible for all such damage, and shall indemnify and save harmless Landlord from any loss, cost, expense, damage or liability resulting from Tenant’s failure to have such insurance as required in this Lease. Such insurance on Tenant’s property shall contain a waiver of subrogation clause in favor of Landlord, or shall name Landlord as an additional insured for the sole purpose of preventing a subrogation claim against Landlord. If Tenant is a self-insurer, in whole or in part, Landlord shall be entitled to the same benefits it would have enjoyed had insurance covering the loss in full with a waiver of subrogation clause been in effect, or as if the Landlord has been named on insurance covering the loss in full as an additional insured for the purpose of preventing a subrogation claim.

Section 7.9 Exoneration; Indemnification and Insurance . Subject to Section 13.5, Tenant will exonerate, indemnify, defend, save and hold harmless Landlord (and any and all Persons claiming by, through or under Landlord) from and against all claims, proceedings, defenses thereof, liabilities, costs, and expenses of any kind and nature, including reasonable legal fees, arising from any act or omission of any of Tenant’s Invitees, or arising from any accident, injury or damage occurring in, on or about the Project, which such accident, damage or injury results or is claimed to have resulted from the negligence or misconduct on the part of any of Tenant’s Invitees, except to the extent resulting from the negligence or willful misconduct of Landlord or any of Landlord’s Invitees. This exoneration, indemnification and hold harmless agreement shall survive the termination of this Lease.

From and after any pre-term occupancy by Tenant, and thereafter during the Lease Term and any period of holding over, Tenant shall maintain in full force and effect a policy of commercial general liability insurance under which Landlord (and its designees) and, to the extent identified to Tenant in writing, Landlord’s mortgagee(s) are added as additional insureds. This policy to be written on ISO Commercial General Liability Coverage Form CG 00 01 (12 07) edition date or equivalent. Any endorsement to the policy should not in any way restrict the premises/operations, personal injury/advertising injury, product liability/completed operations, and contractual liability coverage that is provided in the above form. Each such policy shall be non-cancelable with respect to Landlord without 30 days prior written notice to Landlord, and Tenant shall deliver to Landlord prior to any pre-term occupancy and thereafter prior to the expiration of any then effective coverage (and shall endeavor to provide at least 30 days prior to the expiration of any then effective coverage) a satisfactory written certificate of insurance coverages in an ACORD form 25 (for liability insurance) or such other form as is reasonably approved by Landlord, naming Landlord as certificate holder and otherwise consistent with the terms of this Section 7.9. The minimum limits of liability of such insurance shall be $1,000,000 combined single limit for bodily injury and property damage, each occurrence, and $2,000,000 general aggregate limit, together with an overall umbrella liability limit of $2,000,000. Tenant shall not permit any contractor performing work in excess of $10,000 to do any work at or furnish any materials to be incorporated into the Premises without first delivering to Landlord satisfactory evidence of the Contractor’s commercial general liability insurance, worker’s compensation insurance, automobile insurance, and, if required by Landlord’s lender, statutory lien bonds paid for by Landlord (but such bond shall not be a condition to the approval of Alterations or to the commencement or prosecution of the same), each reasonably acceptable to Landlord and complying with any insurance specifications provided by Landlord. All insurance requirements imposed upon Tenant or its contractors under this Lease shall be subject to the further requirement that the forms of coverage and all companies providing insurance coverage should be licensed or authorized to do business in the Commonwealth of Massachusetts, be in sound financial condition, and maintain an A.M. Best rating of A- or better.

 

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Section 7.10 Landlord’s Access . Landlord and its representatives shall have the right without charge to it and without reduction in Base Rent or Additional Rent, at reasonable times with at least 48 hours prior written notice (except in an emergency) and in such manner as shall not unreasonably interfere with Tenant’s business, to enter the Premises for any reasonable purpose (including, without limitation, showing the Premises to prospective purchasers and lenders and, during the last 12 months of the Lease Term, tenants) and to make entry for the purpose of investigating repair or maintenance problems and to make such repairs as Landlord deems advisable, and to maintain, use, repair or replace pipes, ducts, wires, meters and any other Landlord’s fixtures serving or to serve the Premises or other parts of the Project, or to maintain or repair any portion of the Project, and, in case of an emergency, whether resulting from circumstances in the Premises or elsewhere on the Project, Landlord or its representatives may enter the Premises (forcibly, if necessary) at any time to take such measures as may be needed to cope with such emergency. Such access shall include, but not be limited to, the right to open floors, walls, ceilings, and building systems for the foregoing purposes, provided that any work that is reasonably likely to cause disruption or inconvenience to Tenant shall be scheduled in advance with Tenant (other than in the event of an emergency). All work performed by Landlord in the Premises that may cause disruption or inconvenience to Tenant, including by generation of excessive noise, shall be performed after regular business hours or on weekends except in the event of an emergency or as otherwise permitted by Tenant. Landlord’s entry into the Premises shall be subject to Tenant’s reasonable security requirements, including requiring the use of identification badges, accompaniment by a Tenant representative, and identification verification. Landlord may not store any materials in the Premises other than in areas designated by Tenant for short term periods. During the last 12 months of the Lease Term, and at any other time during the Lease Term that an Event of Default exists, Landlord shall have the right to place signs at and about the Premises (including but not limited to on the exterior of and outside the Building) advertising the Premises as being available for lease.

Section 7.11 No Liens . Tenant shall not permit any mechanics’, laborers’ or materialmen’s liens against the Project or Tenant’s interests in the Premises, this Lease, or the estate created hereby for any labor or materials furnished to Tenant or claimed to have been furnished to Tenant in connection with work of any character performed or claimed to have been performed in or on the Premises by or at the direction or sufferance of Tenant, other than inchoate liens or the filing of notices of contract (provided that Tenant then obtains partial lien waivers and subordinations for any work under such contract as such work progresses). Landlord may condition the right of Tenant to do any work which could result in a lien upon the Project or Tenant’s interests in the Premises, this Lease, or the estate created hereby on the delivery and recording of statutory lien bonds (if required by Landlord’s lender), paid for by Landlord (but such bond shall not be a condition to the approval of Alterations or to the commencement or prosecution of the same).

ARTICLE VIII

SUBLETTING AND ASSIGNMENT

Section 8.1 Subletting and Assignment .

(a) Except as hereinafter set forth, Tenant shall not assign, mortgage, pledge or encumber this Lease nor sublet all or any part of the Premises, nor permit or allow the use of all or any part of the Premises by third party users, such as concessionaires, without, on each occasion, obtaining Landlord’s written consent thereto, which shall be within Landlord’s sole discretion (except as provided below). Tenant may request such consent as provided in Section 8.1(f). Landlord will not unreasonably withhold, delay or condition its consent to a proposed assignment of this Lease or sublease of all or any portion of the Premises under the circumstances described in Section 8.1(b)(i), and will respond to a request for such consent as provided in Section 8.1(f) (subject to Landlord’s recapture right under Section 8.1(e)). Landlord’s consent to an assignment of this Lease or a sublease or all or any portion of the Premises to a Permitted Transferee under the circumstances described in Section 8.1(b)(ii), and Landlord’s consent to use of portions of the Premises by third party users under the circumstances

 

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described in Section 8.1(b)(iii), shall not be required. As used herein, the term “assign” or “assignment” shall be deemed to include, without limitation any transfer of Tenant’s interest in this Lease by operation of law or the merger or consolidation of Tenant with or into any other firm or corporation; provided, however, that the sale, transfer or issuance of stock or other ownership interest in Tenant shall not be deemed to be an assignment or other transfer subject to Landlord’s approval under this Article VIII.

(b) (i) Subject to Landlord’s recapture rights under Section 8.1(e), Landlord will not unreasonably withhold, condition or delay its consent to any assignment of this Lease or any sublease of all or any part of the Premises, so long as: (A) the assignment or sublease will not violate the terms of any Encumbrance; (B) the assignee’s or subtenant’s proposed use is permitted under the terms of this Lease; (C) the assignee or subtenant is qualified to do business in the Commonwealth of Massachusetts and has all applicable permits and licenses to do business from the Premises; (D) Tenant pays to Landlord all of Landlord’s reasonable third party expenses in connection with the review and approval of the assignment or sublease, including, without limitation, reasonable attorneys’ fees (but in any event not to exceed $5,000); (E) there does not then exist an Event of Default and no Event of Default will be created as a result of the proposed assignment or sublease or the proposed use by the assignee or subtenant; and (F) if a sublease, the proposed sublease prohibits any assignment of the sublease or any sub-sublease of any portion of the Premises without the prior written consent of Landlord, which consent shall be subject to the same conditions as apply to consents to assignments or subleases by Tenant under this Article VIII. If an assignment of the Lease or a sublease of all or any part of the Premises is subject to consent by Landlord’s mortgagee under the terms of the applicable financing documents for which there is a Subordination, Non-Disturbance and Attornment Agreement (in the event of a conflict between the applicable financing documents and a Subordination, Non-Disturbance and Attornment Agreement, the Subordination, Non-Disturbance and Attornment Agreement shall control), then Landlord will not be considered to be unreasonable in conditioning its consent to a proposed assignment or sublease on consent by Landlord’s mortgagee.

(ii) Notwithstanding anything to the contrary in Section 8.1(a), Tenant may, upon written notice to, but without the requirement of consent by, Landlord, assign this Lease or sublease all or any portion of the Premises to a Permitted Transferee, so long as: (A) if an assignment (other than an assignment by law, such as a merger), the Permitted Transferee assumes this Lease pursuant to a document satisfactory to Landlord; (B) the assignee or subtenant is qualified to do business in the Commonwealth of Massachusetts and has all applicable permits and licenses to do business from the Premises; (C) Tenant pays to Landlord all of Landlord’s reasonable third party expenses in connection with confirming that the assignment or sublease is permitted under this Section 8.1(b)(ii), including, without limitation, reasonable attorneys’ fees (but in any event not to exceed $2,500); (D) there does not then exist an Event of Default and no Event of Default will be created as a result of the proposed assignment or sublease or the proposed use by the assignee or subtenant, and (E) each of Landlord’s mortgagees has consented to such assignment or sublease if such mortgagee’s consent is required pursuant to the terms of the applicable financing documents for which there is a Subordination, Non-Disturbance and Attornment Agreement (in the event of a conflict between the applicable financing documents and a Subordination, Non-Disturbance and Attornment Agreement, the Subordination, Non-Disturbance and Attornment Agreement shall control).

(iii) Notwithstanding anything to the contrary in Section 8.1(a), Tenant may allow portions of the Premises to be occupied by third parties in connection with research collaborations by such third parties with Tenant or in connection with the performance of vendor agreements between Tenant and such third parties, which research collaborations or vendor agreements have been entered into by Tenant in the ordinary course of its business and not with the intent to circumvent other provisions of this Article VIII.

(c) In the event of any permitted assignment of this Lease, Tenant shall be jointly and severally liable with the assignee for the payment of any and all Base Rent and Additional Rent which may become due by the terms of this Lease and for the performance of all covenants, agreements and conditions on the part of Tenant to be performed hereunder. Except with respect to a transfer to any Permitted Transferee, Tenant shall also pay to Landlord 50% of any Sublease Profit, as defined in

 

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Section 8.1(d), as and when received by Tenant. Any assignment or sublease, even if to a Permitted Transferee, shall be subject to the condition that (i) the new tenant (that is, the assignee or subtenant) and Tenant execute and deliver to Landlord an agreement, in form and substance reasonably satisfactory to Landlord, pursuant to which such new tenant (A) if an assignment (other than an assignment by operation of law, such as a merger), assumes all of the obligations of Tenant under this Lease from and after the date of such assignment, (B) if a sublease, agrees to execute and deliver such estoppel certificates and subordination agreements in the same forms as Landlord may require of Tenant under this Lease, (C) if a sublease, acknowledges that Landlord has no obligations to the subtenant under this Lease, the sublease or otherwise and (D) if a sublease, agrees to maintain the same insurance coverages as the insurance coverages which Tenant is required to maintain under this Lease (to the extent applicable to any subleased space) and to provide evidence thereof to Landlord in accordance with the terms of this Lease; and (ii) the new tenant delivers to Landlord evidence of the insurance coverages required to be maintained by such new tenant under the agreement referenced in clause (i) above. Failure to comply with the requirements of clause (i) of the immediately preceding sentence with respect to an assignment or sublease to a Permitted Transferee shall not render such assignment or sublease void or constitute a default hereunder if such failure is cured within 20 days following Landlord’s written notice of such failure, which notice shall state in bold and prominent print that “FAILURE TO PROVIDE THE DOCUMENTATION REQUIRED BY SECTION 8.1(c) OF THE LEASE MAY RESULT IN A DEFAULT AND/OR THE VOIDING OF A PERMITTED TRANSFER.” No modification of the terms of this Lease or any course of dealing between Landlord and any assignee or sublessee of Tenant’s interest herein shall operate to release or impair Tenant’s obligations hereunder.

(d) As used in Section 8.1(c), “ Sublease Profit ” means: (i) in the case of a sublease of all or any part of the Premises, the amount, if any, by which (A) the rent (including base rent and additional rent) under the sublease exceeds (B) the sum of (I) the Base Rent and Additional Rent under this Lease for the Premises (or part of the Premises) subject to the sublease, determined on a per square foot basis, plus (II) the amortization of the TI Costs in excess of the TI Allowance for the Premises (or part of the Premises) subject to the sublease, determined on a per square foot basis and on the basis of straight-line amortization over the Initial Term, plus (III) the amortization of the costs of the sublease determined on a straight-line basis over the term of the sublease; and (ii) in the case of an assignment of this Lease, the amount, if any, by which (A) any amount paid by the assignee to Tenant for the assignment exceeds (B) the sum of (I) the unamortized TI Costs in excess of the TI Allowance as of the date of the assignment, determined on the basis of straight-line amortization over the Initial Term, plus (II) the costs of the assignment. Sublease Profit shall be determined with respect to a sublease upon each payment of rent under the Sublease. Sublease Profit shall be determined with respect to an assignment upon the assignment.

(e) Notwithstanding anything to the contrary contained in this Article VIII or other provisions of this Lease, in the event that Tenant seeks Landlord’s consent to an assignment of this Lease or a sublease of more than 36,000 square feet of the Premises for substantially the remainder of the Lease Term or for a sublease term of two years or longer, other than to a Permitted Transferee, Landlord, at its option, may terminate this Lease (or if the request is for a sublease of less than all of the Premises, at Landlord’s option, Landlord may terminate this Lease as to the portion requested to be sublet and Landlord and Tenant shall execute an amendment to this Lease to modify the Premises and to adjust Base Rent and Tenant’s Share based upon the modified Leasable Square Footage of the Premises). In such an event, Landlord may enter into a new lease with the proposed assignee or sublessee or any other party on any terms and provisions acceptable to Landlord in Landlord’s sole discretion for the Premises or the portion of the Premises released from this Lease. Landlord’s option to terminate this Lease in whole or in part pursuant to this Section 8.1(e) must be exercised, if at all, within ten Business Days after Tenant submits to Landlord a written request for consent to a proposed assignment or sublease, accompanied by a draft of the proposed assignment or sublease or a proposal letter or letter of intent setting forth in reasonable detail the terms of the proposed assignment or sublease. Notwithstanding the above provisions of this Section 8.1(e) to the contrary, if Landlord exercises its option to terminate this Lease in whole or in part under this Section 8.1(e), Tenant may, by written notice given to Landlord within ten Business Days after Landlord exercises such option, withdraw Tenant’s request for Landlord’s consent to the subject assignment or sublease, in which event this Lease shall not terminate.

 

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(f) Any request by Tenant for Landlord’s consent to a proposed assignment of this Lease or sublease of all or any portion of the Premises (a “ Consent Request ”) shall be made in writing and shall be accompanied by a copy of the proposed assignment or sublease or a proposal letter or letter of intent setting forth in reasonable detail the terms of the proposed assignment or sublease, by current financial statements of the proposed assignee or subtenant (audited if available, and subject to applicable confidentiality agreements), by documents describing the proposed assignee or subtenant and its business to be conducted at the Premises, and by such other documents that Tenant believes may be relevant to Landlord’s consideration of the Consent Request. After Landlord’s receipt of a Consent Request, Tenant shall respond with due diligence to Landlord’s reasonable inquiries regarding the proposed assignment or sublease and will furnish to Landlord such documents reasonably requested by Landlord for Landlord’s consideration of the Consent Request that Tenant has not previously furnished to Landlord. Within 10 Business Days after receipt of a Consent Request and ancillary documents and information required hereunder, Landlord shall give written notice to Tenant consenting or withholding consent to the proposed assignment or sublease. If Landlord fails to give such a written notice to Tenant within such 10 Business Day period, Tenant may give Landlord a follow-up notice demanding a response to the Consent Request, which follow-up notice shall state conspicuously at or near the top of the first page, “THIS IS A FOLLOW-UP NOTICE REQUESTING YOUR CONSENT TO AN ASSIGNMENT OR SUBLEASE BY INFINITY PHARMACEUTICALS, INC. YOUR FAILURE TO RESPOND IN WRITING TO THIS FOLLOW-UP NOTICE WITHIN FIVE BUSINESS DAYS SHALL BE DEEMED TO CONSTITUTE CONSENT.” Within five Business Days after receipt of such a follow-up notice, Landlord shall give written notice to Tenant consenting or withholding consent to the proposed assignment or sublease, and if Landlord fails to give such a written notice within such five Business Day period, Landlord shall be deemed to have consented to the proposed assignment or sublease.

ARTICLE IX

RIGHTS OF MORTGAGEES AND GROUND LESSORS; ESTOPPEL CERTIFICATES

Section 9.1 Subordination to Mortgages and Ground Leases . This Lease is and shall be and remain subordinate to the lien of any present or future mortgage or mortgages, or ground lease, upon the Project, irrespective of the time of execution or time of recording of any such mortgage or mortgages, or ground lease, and to all renewals, extensions, and modifications therefor or amendments thereto; provided that as a condition to such subordination to any present or future mortgage or ground lease, the mortgagee or ground lessor and Tenant shall enter into a Subordination, Non-Disturbance and Attornment Agreement in mutually agreeable form pursuant to which, among other things, the mortgagee or ground lessor agrees not to disturb Tenant’s possession of the Premises pursuant to the terms of this Lease so long as no Event of Default exists. As one of the Lease Effectiveness Conditions, Union Security Insurance Company (Landlord’s present mortgagee) shall enter into a Subordination, Non-Disturbance and Attornment Agreement with Tenant substantially in the form of Exhibit G-1 hereto or in such other form as is reasonably satisfactory to Tenant, and Tenant shall be permitted to record the same. Notwithstanding anything to the contrary in this Lease, this Lease shall not be subordinate to any future mortgage or ground lease unless Landlord, Tenant and the mortgagee or ground lessor shall enter into a Subordination, Non-Disturbance and Attornment Agreement substantially in the form of Exhibit G-2 or in such other form as shall be negotiated by Landlord, Tenant and Landlord’s lender in good faith, and Tenant shall be permitted to record the same. Upon five Business Days’ written request from Landlord, any holder of a mortgage or ground lease on the Project or any successor in interest to Landlord, whether by purchase, foreclosure, deed in lieu of foreclosure or otherwise, Tenant shall enter into an commercially reasonable attornment agreement, in the form requested by such party, with such party; provided that as a condition of entering into an attornment agreement with a holder of a mortgage or ground lease that is superior to this Lease, Tenant may require that the attornment agreement include commercially reasonable non-disturbance provisions for the benefit of Tenant.

Section 9.2 Lease Superior at Mortgagee’s or Ground Lessor’s Election . At the request in writing of any mortgagee, or ground lessor, of the Project, this Lease shall be deemed superior to such mortgage, or ground lease, whether this Lease was executed before or after such mortgage, or ground lease, and Tenant shall execute such documents to effect the foregoing in recordable form as such mortgagee, or ground lessor, shall request.

 

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Section 9.3 Notice to Mortgagee and Ground Lessor . Upon receipt of a written request from Landlord or any holder of a mortgage, on all or any part of the Project, or the ground lessor thereof, Tenant will thereafter send any such holder copies of all notices (including, but not limited to, notices of default or termination) given by Tenant to Landlord in accordance with any provision of this Lease. In the event of any failure by Landlord to perform, fulfill or observe any agreement by Landlord herein, any such holder may at its election cure such failure or breach for and on behalf of Landlord within 15 Business Days after the time provided herein for Landlord to cure the same together with such longer period (but in any event not to exceed 180 days) as may be reasonably necessary to obtain possession of the Premises to cure the default, provided that such holder or ground lessor diligently commences the proceedings necessary to obtain possession and prosecutes the same to completion. Nothing in this Section 9.3 shall be deemed to prohibit or delay Tenant from the exercise of its express remedies pursuant to this Lease pursuant to Sections 3.5(e), 6.3, 12.7(b) and 12.7(c). In the event of any inconsistency between this Section and any similar provision in a Subordination, Non-Disturbance and Attornment Agreement entered into by Tenant and any mortgagee or ground lessor, the provisions of the Subordination, Non-Disturbance and Attornment Agreement shall be controlling.

Section 9.4 Limitations on Obligations of Mortgagees, Ground Lessors and Successors . The holder of a mortgage or ground lease or any successor-in-interest to any of them or to Landlord shall not be: (a) bound by any payment of an installment of Base Rent or Additional Rent which may have been made more than 30 days before the due date of such installment; (b) bound by any amendment or modification to this Lease made without the consent of the holder of a mortgage or ground lease or such successor in interest to the extent that such consent is required pursuant to the terms of a Subordination, Non-Disturbance and Attornment Agreement; (c) liable for any previous act or omission of Landlord (or its predecessors in interest) (but shall be obligated to cure any defaults continuing after the date of such succession); (d) responsible for any monies owing by Landlord to the credit of Tenant or subject to any credits, offsets, claims, counterclaims, demands or defenses which Tenant may have against Landlord (or any of its predecessors in interest) except for those offsets expressly provided under this Lease; (e) bound by any covenant to undertake or complete any construction of the Premises or any portion thereof (expressly excluding Landlord’s repair and maintenance obligations hereunder or to the extent of construction obligations agreed to in any Subordination, Non-Disturbance and Attornment Agreement); or (f) obligated to make any payment to Tenant other than any security deposit actually delivered to holder of a mortgage or ground lease or such successor in interest or payments expressly provided under this Lease. In the event of any inconsistency between this Section and any similar provision in a Subordination, Non-Disturbance and Attornment Agreement entered into by Tenant and any mortgagee or ground lessor, the provisions of the Subordination, Non-Disturbance and Attornment Agreement shall be controlling.

Section 9.5 Estoppel Certificates . Tenant shall, at any time and from time to time, within fifteen days after written request by Landlord or any holder of a mortgage on all or a portion of the Project or the ground lessor thereof, execute, acknowledge and deliver to Landlord and any mortgagee or ground lessor a statement in writing certifying that (except as may be otherwise specified by Tenant): (i) this Lease is presently in full force and effect and unmodified; (ii) Tenant has accepted possession of the Premises; (iii) any improvements required by the terms of this Lease to be made by Landlord have been completed to the satisfaction of Tenant; (iv) no rent under this Lease has been paid more than 30 days in advance of its due date; (v) the addresses for notices to be sent to Tenant is as set forth in this Lease or as specified in such certificate; (vi) Tenant, to the best of its knowledge, as of the date of executing the certificate has no charge, lien or claim of offset under this Lease, or otherwise, against rents or other charges due or to become due hereunder; (vii) to the best of its knowledge, Tenant is not in default under this Lease; (viii) to the best of Tenant’s knowledge, Landlord is not in default of this Lease; and (ix) such other information as Landlord may reasonably request about this Lease or Tenant’s occupancy.

 

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Landlord shall, at any time and from time to time, within fifteen days after written request by Tenant, execute, acknowledge and deliver to Tenant and any permitted or prospective assignee, permitted or prospective subtenant or lender of Tenant a statement in writing certifying that (except as may be otherwise specified by Landlord): (i) this Lease is presently in full force and effect and unmodified; (ii) any improvements required by the terms of this Lease to be made by Tenant have been completed to the satisfaction of Landlord; (iii) the addresses for notices to be sent to Landlord is as set forth in this Lease or as specified in such certificate; (iv) to the best of its knowledge, Landlord is not in default under this Lease; (v) to the best of Landlord’s knowledge, Tenant is not in default of this Lease; and (vi) such other information as Tenant may reasonably request about this Lease or Tenant’s occupancy.

As between Landlord and Tenant, nothing contained in an estoppel certificate delivered pursuant to this Section 9.5 shall be deemed to constitute a waiver of any of Landlord’s or Tenant’s rights under this Lease, including, but not limited to, any right to audit, or deemed to be a modification or amendment of this Lease. If there are any conflicts between the terms of an estoppel certificate and this Lease, the terms of this Lease will prevail.

ARTICLE X

CASUALTY

Section 10.1 Damage From Casualty .

(a) If any portion of the Building is damaged by fire or other casualty, Tenant shall give Landlord written notice of such casualty promptly after Tenant becomes aware of such casualty. Within 60 days after Tenant gives Landlord written notice of such casualty or Landlord otherwise has knowledge of such casualty, Landlord shall reasonably estimate, and give Tenant written notice (the “ Restoration Notice ”) of, the period commencing with the date of such notice (the “ Restoration Period ”) that Landlord anticipates will be reasonably required to perform the restoration work which is the responsibility of Landlord as provided below. For any material casualty (i.e. costing in excess of $250,000 to repair or restore), Landlord will consult with a qualified general contractor to estimate the Restoration Period, which general contractor shall be independent of Landlord and shall not have performed work for Landlord or any affiliate of Landlord during the ten (10) years immediately preceding such consultation. If (x) the Restoration Notice states that the Restoration Period will be longer than 270 days, or (y) the casualty occurs in the last year of the Lease Term and the Restoration Period stated in the Restoration Notice exceeds one-half of the then remaining Lease Term, then either Landlord or Tenant may terminate this Lease by giving to the other written notice of termination within ten days after Landlord gives Tenant the Restoration Notice. Such notice of termination shall be effective on the date thereof, and if Tenant is then occupying the Premises, Tenant shall thereafter have a reasonable period of time in which to vacate the Premises. If (i) the Restoration Period stated in the Restoration Notice is such that neither Landlord nor Tenant has the right to terminate this Lease pursuant to this Section 10.1(a), or (ii) the Restoration Period stated in the Restoration Notice is such that either Landlord or Tenant has the right to terminate this Lease pursuant to this Section 10.1(a), but neither Landlord nor Tenant exercises such right to terminate this Lease, then this Lease shall not terminate; and in such event, Landlord shall, unless Landlord exercises its termination right pursuant to Section 10.3, promptly commence, and thereafter diligently prosecute with reasonable dispatch, to repair or rebuild the Building to substantially its condition immediately prior to the casualty (subject, however, to Legal Requirements then in existence). Tenant shall thereafter repair and restore its fixtures and personal property to the extent reasonably required for Tenant’s occupancy.

(b) If, pursuant to Section 10.1(a), Landlord is required to restore the Premises and Landlord fails to substantially complete such restoration within 60 days after the end of the Restoration Period (subject to extension for Force Majeure (but in any event not to exceed 60 days)), then Tenant shall have the right to terminate this Lease upon 30 days prior written notice to Landlord. If Landlord fails to substantially complete such restoration work within such 30 day period, then this Lease shall terminate as of such 30 th day.

 

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(c) Notwithstanding any other provisions of this Section 10.1 to the contrary, Landlord shall not be obligated to commence repair or restoration work prior to adjustment of its insurance claim, nor shall Landlord be required to expend sums in excess of “net recovered insurance proceeds”. The term “ net recovered insurance proceeds ” shall mean the amount of any insurance proceeds actually paid by the insurer, less (i) the Landlord’s reasonable third party cost of obtaining the same (including attorneys’ fees and appraisal fees) and (ii) if (A) the applicable financing documents for which there is a Subordination, Non-Disturbance and Attornment Agreement authorize Landlord’s mortgagee or ground lessor to receive any insurance proceeds and not make such insurance proceeds available for restoration (in the event of a conflict between the applicable financing documents and a Subordination, Non-Disturbance and Attornment Agreement, the Subordination, Non-Disturbance and Attornment Agreement shall control), and (B) pursuant to such authority, Landlord’s mortgagee or ground lessor does in fact receive insurance proceeds which it does not make available for restoration, the amount of the insurance proceeds so received by Landlord’s mortgagee or ground lessor and not made available for restoration. If Landlord’s mortgagee or ground lessor receives any insurance proceeds and does not make such insurance proceeds available for restoration, then Tenant may terminate this Lease upon 30 days’ prior written notice to Landlord, unless, by the end of such 30 day period, Landlord commits in writing to Tenant to restore the Premises and provides to Tenant evidence reasonably satisfactory to Tenant that Landlord has or will have available funds sufficient to complete the restoration.

Section 10.2 Abatement of Rent . In the event that the provisions of Section 10.1 shall become applicable, the Base Rent shall be abated or reduced proportionately during any period in which, by reason of any such damage or destruction, Tenant is unable to use a portion of the Premises for general office use, and such abatement or reduction shall continue (but may be adjusted from time to time based on the extent of the interference with Tenant’s operations) for the period commencing with such destruction or damage and ending with the substantial completion by Landlord of such work, repair and/or reconstruction as Landlord is required to do.

Section 10.3 Landlord’s Right to Terminate . Notwithstanding the foregoing, Landlord may terminate this Lease following: (a) damage or destruction to the Building to the extent of 50% or more of the cost of replacement thereof; (b) the refusal of the applicable insurance carrier to pay funds sufficient for the cost to repair or replace so long as Landlord is maintaining the insurance coverages required under this Lease; or (c) the refusal of any applicable mortgagee or ground lessor to release insurance proceeds to pay for costs of restoration to the extent permitted under the terms of the applicable financing documents for which there is a Subordination, Non-Disturbance and Attornment Agreement (in the event of a conflict between the applicable financing documents and a Subordination, Non-Disturbance and Attornment Agreement, the Subordination, Non-Disturbance and Attornment Agreement shall control). Landlord may exercise the right to so terminate this Lease by written notice to Tenant given within 60 days after the date of the damage or 60 days after the date Landlord receives written notice of such damage, whichever is later. Such notice of termination shall be effective on the date thereof.

ARTICLE XI

EMINENT DOMAIN

Section 11.1 Eminent Domain; Right to Terminate and Abatement in Rent . If more than 50% of the Premises shall be taken, or if a conveyance shall be made in anticipation thereof, for any street or other public use, by action of the municipal, state, federal or other authorities, after the execution hereof and before the expiration of the Lease Term, then this Lease and the Lease Term shall terminate at the election of either party (given by written notice to the other within 90 days of the taking or within 90 days of notice of the taking), and such election may be made in case of any such taking notwithstanding the entire interest of Landlord may have been divested by such taking. If less than all or substantially all of the Premises is taken, or a conveyance made in anticipation thereof, but the result of such event is that the Premises will be reduced by more than 20%, then the Lease Term shall terminate at the election of Tenant (given by written notice to Landlord within 90 days of the taking or within 90 days of notice of the taking). In case of any such taking or destruction of, or damage to, the Premises, rendering the same or any part thereof unfit for use and occupation, a just proportion of the Base Rent hereinbefore reserved according to the nature and extent of the injury sustained by the Premises shall be suspended or abated

 

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until the Premises or, in case of such taking, what may remain thereof, shall have been put in proper condition for use and occupation. To the extent that the Premises, upon having been put in proper condition for use and occupation are smaller, the Base Rent hereinbefore reserved shall be reduced for the balance of the Lease Term in the same proportion which the reduction in space bears to the original Leasable Square Footage of the Premises.

Section 11.2 Restoration . If this Lease is not terminated as provided in Section 11.1, Landlord shall apply so much of the available proceeds of the eminent domain award as are required to restore the Project and the Premises to a condition, to the extent practical, substantially the same as that immediately preceding the taking, but subject to zoning laws and building codes then in existence. If the available proceeds of the eminent domain award are insufficient, in Landlord’s judgment, for that purpose, Landlord shall have no obligation to expend funds in excess of said proceeds and Landlord, in consultation with Tenant, shall reasonably determine which portions of the Project, if any, shall be restored. The term “ available proceeds ” shall mean the amount of the award paid to Landlord, less (a) the reasonable out of pocket cost of obtaining the same (including reasonable attorneys’ fees and appraisal fees) and (b) if (i) the applicable financing documents for which there is a Subordination, Non-Disturbance and Attornment Agreement authorize Landlord’s mortgagee or ground lessor to receive any proceeds and not make such proceeds available for restoration (in the event of a conflict between the applicable financing documents and a Subordination, Non-Disturbance and Attornment Agreement, the Subordination, Non-Disturbance and Attornment Agreement shall control), and (ii) pursuant to such authority, Landlord’s mortgagee or ground lessor does in fact receive proceeds which it does not make available for restoration, the amount of the proceeds so received by Landlord’s mortgagee or ground lessor and not made available for restoration. If Landlord’s mortgagee or ground lessor receives any proceeds and does not make such proceeds available for restoration, then Tenant may terminate this Lease upon 30 days’ prior written notice to Landlord, unless, by the end of such 30 day period, Landlord commits in writing to Tenant to restore the Premises and provides to Tenant evidence reasonably satisfactory to Tenant that Landlord has or will have available funds sufficient to complete the restoration. In addition, in the event Landlord fails to commence restoration of the Project and/or the Premises within 60 days after the taking, Tenant shall have the right to terminate the Lease upon 60 days’ prior written notice to Landlord.

Section 11.3 Landlord to Control Eminent Domain Action . Landlord reserves all rights to compensation for damage to the Premises or any part thereof, or the leasehold hereby created, heretofore accrued or hereafter to accrue, by reason of any taking for public use of said Premises or any portion thereof, or right appurtenant thereto, or privilege or easement in, through, under or over the same, and by way of confirmation of the foregoing Tenant hereby assigns all rights to such damages heretofore accrued or hereafter accruing during the Lease Term to Landlord. Notwithstanding the immediately preceding sentence to the contrary, in the event of a taking that results in a termination of this Lease pursuant to this Article XI, Landlord shall pay over to Tenant out of any compensation award received by Landlord an amount equal to the product of (a) the percentage of the Premises taken multiplied by (b) the unamortized Tenant’s TI Costs (as defined below) as of the date of the award. For purposes of the immediately preceding sentence, “ Tenant’s TI Costs ” means the actual TI Costs not paid or reimbursed by the Space Planning Allowance, the TI Allowance, the Supplemental Allowance or the Excess Base Building Allowance, and Tenant’s TI Costs shall be amortized on a straight-line basis over the Initial Term. Nothing herein contained shall limit Tenant’s right to any separate award for the taking of personal property, moving expenses, or other items the payment of which shall not reduce the award payable to Landlord.

ARTICLE XII

DEFAULT AND REMEDIES

Section 12.1 Event of Default . As used herein, “ Event of Default ” shall mean the occurrence and/or existence of any one or more of the following: (a)(i) Tenant shall fail to pay installment of Base Rent or Additional Rent when due and such failure continues for five days after Landlord gives Tenant written notice thereof, or (ii) Landlord having given the notice specified in clause (a)(i) two times in any 12 month period with respect to regularly scheduled installments of Base Rent or Additional Rent, Tenant

 

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shall fail, on another occasion within the same 12 month period, to pay any regularly scheduled installment of Base Rent or Additional Rent when due and such failure continues for five days; or (b) Tenant shall neglect or fail to perform or observe any of the other covenants or undertakings herein on its part to be performed or observed and such neglect or failure shall continue for 30 days after notice to Tenant; provided that if the default is other than a default under clause (a) above, or clauses (c) through (i) below, and is such that it cannot be cured within 30 days, but is capable of being cured, such 30 day period shall be extended for a reasonable period of time necessary to complete such cure, provided that Tenant commences to cure such default within said 30 day period, continues to do so diligently, and thereafter completes such cure; or (c) there is filed by Tenant any case, petition, proceeding or other action under any Bankruptcy Law; or (d) any other proceedings shall be instituted against Tenant under any Bankruptcy Law and not be dismissed within 60 days; or (e) Tenant shall execute an assignment of its property for the benefit of its creditors; or (f) a receiver, custodian or other similar officer for Tenant shall be appointed and not be discharged within 60 days; or (g) the estate hereby created shall be taken by execution or by other process of law and is not redeemed by Tenant within 30 days thereafter; or (h) an assignment or sublease in violation of the terms of this Lease; or (i) any other event constituting an Event of Default under other Sections of this Lease, including, without limitation, Section 2.6. If, as provided above, Landlord is responsible for collecting rent via electronic funds transfer, then Tenant, other than having inadequate funds, will not be subject to default for any errors or omissions by Landlord or Landlord’s bank.

Section 12.2 Landlord’s Remedies .

(a) Upon the occurrence of an Event of Default and after the lapse of any applicable period of cure, Landlord may, immediately or at any time thereafter (notwithstanding any license or waiver of any former breach or waiver of the benefit hereof, or consent in a former instance), and without demand or notice, in person or by agent or attorney, enter the Premises or any part thereof and repossess the same as of its former estate, and/or, by written notice to Tenant, terminate Tenant’s right to possession under this Lease without terminating this Lease or terminate this Lease, and in any such event expel Tenant and those claiming through or under it and remove their effects (forcibly, if necessary) without being deemed guilty of any manner of trespass and without prejudice to any remedy which might otherwise be used for arrears of Base Rent or Additional Rent or breach of covenant. Whether or not Landlord shall have terminated this Tenant’s or Tenant’s right to possession, Landlord, in addition to all other remedies which it may have at law or equity, and not in limitation thereof, shall have the remedies provided in this Article XII.

(b) If, pursuant to Section 12.2(a), Landlord terminates Tenant’s right of possession of the Premises without terminating this Lease, then Tenant shall pay to Landlord during the remainder of the Lease Term the Base Rent and Additional Rent in installments as and when the same become due and payable, subject to reduction by any rent actually received by Landlord as a result of a re-letting of the Premises (net of the reasonable and customary costs of re-letting, including remodeling costs, brokerage commissions and reasonable attorneys’ fees). Landlord shall exercise commercially reasonable efforts to re-let the Premises to mitigate damages, and Landlord may re-let the Premises or any part or parts thereof, either in the name of Landlord or otherwise for a term or terms which may, at Landlord’s option, be less than or exceed the period which would otherwise have constituted the balance of the Lease Term and may grant concessions or free rent. The good faith failure of Landlord to re-let the Premises or any part or parts thereof, or, if the Premises are re-let, the good faith failure to collect the rents due under such re-letting, shall not release or affect Tenant’s liability for damage so long as Landlord does not act arbitrarily or capriciously. Any suit brought to collect the amount of the deficiency for any month or other period shall not prejudice in any way the right of Landlord to collect the deficiency for any subsequent month or period by a similar proceeding. Landlord, at Landlord’s option, may make such alterations, repairs, replacements and decorations on the Premises as Landlord in Landlord’s sole but good faith business judgment considers advisable and necessary for the purpose of re-letting the Premises, and the making of such alterations or decorations shall not operate or be construed to release Tenant from liability hereunder.

 

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(c) If, pursuant to Section 12.2(a), Landlord terminates this Lease, Tenant shall forthwith pay to Landlord as damages, in addition to all sums which were due prior to the date of such termination, a sum equal to the amount by which the Base Rent and Additional Rent for the remainder of the Lease Term exceeds the fair rental value of the Premises for the remainder of the Lease Term, discounted to present value using a then market rate of interest as reasonably determined by Landlord. For the purposes of computing damages payable pursuant to this Section 12.2(c), the Additional Rent with respect to Taxes and Operating Costs for the remainder of the Lease Term will be assumed to be the product of such Additional Rent for the most recently ended fiscal, calendar or lease year, as the case may be, times the number of years remaining of the Lease Term.

(d) Tenant shall be responsible to Landlord for all expenses which Landlord may incur in connection with the enforcement of Landlord’s rights after an Event of Default, including, without limitation, reasonable legal expenses, attorneys’ fees, brokerage fees, and the cost of putting the Premises in good order or preparing the same for rental.

(e) In no event, other than a holdover, shall Tenant be liable for consequential or any indirect damages under this Lease.

Section 12.3 Reimbursement of Landlord . Upon the occurrence of an Event of Default, Tenant will, in addition to paying Landlord all amounts due under the terms and provisions of this Lease, including, without limitation, Section 12.9, reimburse Landlord for all reasonable expenses incurred by Landlord in collecting such rent or in obtaining possession of, or in re-letting the Premises, or in defending any action, including expenses for reasonable counsel fees and commissions. If on termination of this Lease by expiration or otherwise, Tenant shall fail to remove any of its property from the Premises as provided for herein, Landlord shall be authorized, in its sole option, and in Tenant’s name and on its behalf, either (a) to cause such property to be removed and placed in storage for the account and at the expense of Tenant; or (b) to sell such property at public or private sale, with or without notice, and to apply the proceeds thereof, after the payment of all expenses of removal, storage and sale, to the indebtedness, if any, of Tenant to Landlord, the surplus, if any, to be paid to Tenant. All sums payable by Tenant under this Article XII shall be deemed Additional Rent.

Section 12.4 Landlord’s Right to Perform Tenant’s Covenants . If an Event of Default shall occur, Landlord, in its sole discretion may after due notice to, or demand upon, Tenant, make any payment or perform any other act on the part of Tenant to be made and performed as in this Lease provided, in such manner and to such extent as Landlord may reasonably deem desirable, and in exercising any such rights, Landlord may pay necessary and incidental costs and expenses, employ counsel, and incur and pay reasonable attorneys’ fees. The making of any such payment or the performing of any other act by Landlord pursuant to this Article shall not waive, or release Tenant from, any obligations of Tenant in this Lease contained. All sums so paid by Landlord and all reasonably necessary and incidental costs and expenses in connection with the performance of any such act by Landlord shall, except as otherwise in this Lease expressly provided, be payable to Landlord on demand, and Tenant covenants to pay any such sum or sums promptly, and Landlord shall have (in addition to any other right or remedy of Landlord) the same rights and remedies in the event of the non-payment thereof by Tenant as in the case of default by Tenant in the payment of the Base Rent. Whenever practicable, Landlord, before proceeding as provided in this Section 12.4, shall give Tenant notice in writing of the failure of Tenant which Landlord proposes to remedy, and shall allow Tenant such length of time as may be reasonable in the circumstances, consistent with any grace periods contained herein, but not exceeding ten days from the giving of notice, to remedy the failure itself and, if Tenant shall not remedy the failure in the time so allowed, Landlord shall be deemed to have given “due notice” and may proceed as provided in this Section 12.4; provided that nothing in this Section shall prevent Landlord from acting without notice to Tenant in case of any emergency wherein there is danger to property or person or where there may exist any violation of Legal Requirements including but not limited to the presence of Hazardous Materials, in which event no notice shall be required.

 

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Section 12.5 Cumulative Remedies . The specified remedies to which Landlord may resort under the terms of this Lease, or under the provisions of applicable law, are cumulative and not intended to be exclusive of any other remedies or means of redress to which Landlord may be lawfully entitled in case of any breach or threatened breach by Tenant of any provisions of this Lease. The failure of Landlord to insist in any one or more cases upon the strict performance of any of the covenants of this Lease or to exercise any option contained herein shall not be construed as a waiver or a relinquishment for the future of such covenant or option. Receipt by Landlord of any Base Rent or Additional Rent payment with knowledge of the breach of any covenants hereof shall not be deemed a waiver of such breach. No waiver by Landlord of any provision of this Lease shall be deemed to have been made unless expressed in writing and signed by it. In addition to the other remedies provided in this Lease, Landlord shall be entitled to restraint by injunction of any violation or attempted or threatened violation of any of the covenants, conditions or provisions of this Lease.

Section 12.6 Expenses of Enforcement . Tenant shall pay all reasonable expenses and reasonable attorneys’ fees incurred by Landlord in enforcing any obligation or any remedies hereunder including, without limitation, in connection with collection of Base Rent or Additional Rent, recovery by Landlord of the Premises, or in any litigation in which Landlord shall become involved by reason of any act or negligence of Tenant’s Invitees or any breach of this Lease by Tenant. Landlord shall pay all reasonable expenses and reasonable attorneys’ fees incurred by Tenant in enforcing any obligation or any remedies hereunder including any litigation in which Tenant shall become involved by reason of any act or negligence of Landlord or any breach of this Lease by Landlord.

Section 12.7 Landlord’s Default .

(a) Landlord shall not be deemed to be in default hereunder unless such default shall remain uncured for more than 30 days following written notice from Tenant to Landlord specifying the nature of such default, or such longer period as may be reasonably required to correct such default. Landlord’s liability to keep, maintain, and repair shall always be limited to the cost of making such repair or accomplishing such maintenance or repair. In no event whatsoever shall Landlord be liable for consequential or any indirect damages under this Lease. The provisions of this Section 12.7(a) are further subject to the provisions of Articles X and XI dealing with eminent domain and fire and other casualty, and Section 6.3 dealing with interruption of Services.

(b) If Landlord fails to cure any default by Landlord within the period provided in Section 12.7(a), Tenant may give Landlord an additional written notice confirming that the default has not been cured and that Tenant intends to cure such default, and, if Landlord fails to cure such default within five (5) Business Days after such notice, Tenant may, without waiving the default, take such steps as are reasonably appropriate to cure the default. The reasonable out-of-pocket cost of Tenant’s cure of a default by Landlord shall be due and payable 15 days after submission by Tenant to Landlord of an invoice therefor together with such documentation as Landlord shall reasonably require showing the actual costs incurred by Tenant. In the event of an emergency consisting of an imminent threat of injury to persons or damage to Tenant’s property at the Premises, Tenant shall have the right to make such temporary, emergency repairs as may be reasonably necessary to prevent such damage to the property of Tenant at the Premises, or such injury to persons, without prior notice, but upon contemporaneous notice, to Landlord. Landlord shall reimburse Tenant for the reasonable out-of-pocket costs actually incurred by Tenant in making such emergency repairs to the Premises within 15 days after submission by Tenant to Landlord of an invoice therefor together with such documentation as Landlord shall reasonably require showing the actual costs incurred by Tenant. The reasonable out-of-pocket costs incurred by Tenant in accordance with this Section 12.7(b) are called the “ Self-Help Costs ”).

(c) Tenant may offset the Self-Help Costs against Base Rent and Additional Rent only if Tenant first obtains (i) a judgment for recovery of the Self-Help Costs in a court of competent jurisdiction which is no longer subject to appeal, (ii) a determination that the Self-Help Costs are owing by Landlord in an arbitration conducted pursuant to the following provisions of this Section 12.7(c), or (iii) a written acknowledgment by Landlord that Landlord does not contest that the Self-Help Costs are due. Any offset which Tenant is entitled to take pursuant to this Section 12.7(c) shall include interest on the Self-Help Costs from the due date at a per annum rate equal to 3% plus the prime rate of Bank of America (or any successor) in effect from time to time. Without limiting Tenant’s remedies for Landlord’s

 

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failure to pay any Self-Help Costs, Tenant may submit a claim for the Self-Help Costs to binding arbitration before a single disinterested arbitrator having not less than ten years’ experience in the operation, maintenance and leasing of commercial real estate to be selected and held by the American Arbitration Association in Boston, Massachusetts in accordance with its expedited commercial rules and regulations then in effect. Landlord and Tenant shall use diligent good faith efforts to complete the arbitration within 30 days following the submission of such dispute to arbitration. The determination of the arbitrator shall be conclusive upon the parties and judgment upon the same may be entered in any court having jurisdiction. The party which does not prevail in the arbitration as determined by the arbitrator shall pay for the arbitrator and related costs of the arbitration (but not the attorneys’ fees of the prevailing party). Except as provided in this Section 12.7(c), Tenant shall not have any right of offset with respect to Self-Help Costs.

(d) Except as otherwise expressly provided in this Lease and except for constructive eviction, Tenant shall not have the right to terminate this Lease by reason of a default by Landlord.

Section 12.8 Limitation of Liability .

(a) The obligations of Landlord hereunder shall be binding upon Landlord and each succeeding owner of Landlord’s interest hereunder only during the period of such ownership, and Landlord and each succeeding owner shall have no liability whatsoever except for its obligations during each such respective period (provided that nothing herein shall relieve any landlord of its obligations occurring during its ownership period). Tenant agrees for itself and each succeeding holder of Tenant’s interest, or any portion thereof, hereunder, that any judgment, decree or award obtained against Landlord or any succeeding owner of Landlord’s interest, which is in any manner related to this Lease, the Premises or Tenant’s use and occupancy of the Premises or the Outside Areas, whether at law or in equity, shall be satisfied out of Landlord’s interest in the land and buildings then comprising the Project and the profits, proceeds and awards therefrom, and further agrees to look only to such assets (or profits, proceeds and awards thereof) and to no other assets of Landlord for satisfaction. Neither Landlord nor any Person executing this Lease on behalf of Landlord, nor any partner, limited or general, or any officer, director, employee, member, trustee, beneficiary, or owner of Landlord, nor any subsequent Landlord, or any partner, limited or general, or any officer, director, employee, member, trustee, beneficiary, or owner of any subsequent Landlord shall have any personal liability hereunder.

(b) No Person executing this Lease on behalf of Tenant, nor any stockholder, partner, limited or general, or any officer, director, employee, member, trustee, beneficiary, or owner of Tenant, shall have any personal liability hereunder.

Section 12.9 Late Payment and Administrative Expense . If Tenant shall fail to pay Base Rent, Additional Rent or other charges after the same become due and payable under this Lease, such unpaid amounts shall bear interest from the due date thereof to the date of payment at the lesser of (a) a per annum rate equal to 3% plus the prime rate of Bank of America (or any successor) in effect on the day the payment became due and subject to change thereafter or (b) the maximum rate permitted by applicable law (“ Interest Payment ”). In addition, if Landlord is required to redeposit any check which is returned for insufficient funds or if Tenant shall fail to pay Base Rent, Additional Rent or other charges on or before the date on which the same become due and payable, then Tenant shall also pay to Landlord an administrative expense charge (“ Administrative Expense ”) of 3% of the amount thereof for each calendar month or part thereof after the due date of such payment until such payment is received by Landlord. The provisions herein for Interest Payment and Administrative Expense shall not be construed to relieve Tenant of the obligation to pay Base Rent, Additional Rent and all other charges when due under this Lease and shall be in addition to and not in limitation of Landlord’s other remedies as provided for in this Lease. Notwithstanding the foregoing to the contrary, Tenant shall not be liable for any Interest Payment or Administrative Expense for the first two late payments in any calendar year unless and until Tenant receives notice of such late payment and fails to make the same within five (5) Business Days thereafter.

 

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ARTICLE XIII

MISCELLANEOUS PROVISIONS

Section 13.1 Brokers . Each party represents that it has not dealt with any Person in connection with the Premises or the negotiation or execution of this Lease other than officers, employees and attorneys of Landlord, Tenant and Brokers. Each party shall indemnify and save harmless the other from and against all claims, liabilities, costs and expenses incurred as a result of any breach of the foregoing representation. The fees payable to Brokers for this Lease shall be payable by Landlord subject to and in accordance with the terms of separate agreements between Landlord and Brokers.

Section 13.2 Quiet Enjoyment . Tenant shall, so long as this Lease remains in full force and effect, peaceably and quietly have and hold the Premises without hindrance or molestation by any Person or Persons lawfully claiming by, through or under, Landlord, subject, however, to the terms of this Lease.

Section 13.3 Tenant’s Request for Landlord’s Action . If Tenant requests Landlord to take any action which is not required of Landlord pursuant to this Lease, Landlord may, before taking such action, give Tenant an estimate of the reasonable attorneys’ fees, expenses and disbursements anticipated to be incurred by Landlord in connection with such action, and if Tenant elects to have Landlord take such action, Tenant shall pay to Landlord as Additional Rent Landlord’s reasonable attorneys’ fees, expenses and disbursements in connection with such action, with payment to be made by Tenant within 30 days after billing therefor by Landlord.

Section 13.4 Notices . Any notice, demand, request or statement required or intended to be given or delivered under the terms of this Lease shall be in writing, shall be addressed to the party to be notified at the address or addresses set forth in the Summary of Basic Terms or at such other address in the continental United States as each party may designate for itself from time to time by notice hereunder, shall be deemed to have been given, delivered or served upon the earlier of receipt or refusal to accept delivery and shall be delivered by (a) U.S. Mail, with proper postage prepaid, certified or registered, return receipt requested, (b) nationally recognized overnight delivery carrier with delivery fees either prepaid or an arrangement, satisfactory with such carrier, made for the payment of such fees, (c) email (provided that notice is simultaneously given by another method specified herein) or (d) personal delivery. Notice for Landlord or Tenant may be given by counsel for the applicable party.

Section 13.5 Waiver of Subrogation . Landlord and Tenant hereby release each other, to the extent of their respective insurance coverages, from any and all liability for any loss or damage caused by fire, any of the extended coverage casualties, or other casualties insured against, even if such fire or other casualty shall be brought about by the fault or negligence of the party benefited by the release or its agents. Tenant’s fire, extended coverage, and other insurance policies will include such a clause. To the extent that Tenant is a self-insurer with respect to personal property, the provisions of Section 7.8 shall be applicable.

Section 13.6 Entire Agreement; Execution; Time of the Essence and Headings and Table of Contents . This Lease together with all Exhibits and Schedules referred to herein and the Summary of Basic Terms, sets forth the entire agreement between the parties hereto and cannot be modified or amended, except in a writing duly executed by the respective parties. This Lease, together with all Exhibits and Schedules referred to herein and the Summary of Basic Terms, supersedes all previous written and oral negotiations, understandings and agreements regarding the subject matter of this Lease. Neither Landlord nor any Person acting on behalf of Landlord has made any representations to Tenant on which Tenant has relied in entering into this Lease except any representations expressly stated in this Lease. This Lease is executed as a sealed instrument and in multiple counterparts, all copies of which are identical, and any one of which is to be deemed to be complete in itself and may be introduced in evidence or used for any purpose without the production of any other copy. Time is of the essence with respect to the obligations of Tenant and Landlord to be performed within a specific time frame in this Lease. The headings throughout this Lease and the Table of Contents are for convenience of reference only, and shall in no way be held or deemed to define, limit, explain, describe, modify or add to the interpretation, construction or meaning of any provision of this Lease.

 

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Section 13.7 Partial Invalidity . If any term or condition of this Lease or its application to any Person or circumstance shall to any extent be in violation of or unenforceable under any law, rule, regulation or order (including any court order) now existing or hereafter enacted or entered by any court or other governmental entity having competent jurisdiction (including after all appeals therefrom), the remainder of this Lease, or the application of such term or condition to Persons or circumstances other than those as to which it is invalid or unenforceable, shall not be affected thereby and shall be enforceable to the fullest extent not prohibited by law.

Section 13.8 No Waiver . No assent, express or implied, by Landlord to any breach of any agreement or condition herein contained on the part of Tenant to be performed or observed, and no waiver, express or implied, of any such agreement or condition shall be deemed to be a waiver of or an assent to any succeeding breach of the same or any other agreement or condition; the acceptance by Landlord of Base Rent or Additional Rent due hereunder (whether such payment is made by Tenant or another Person), or silence by Landlord as to any breach, shall not be construed as waiving any of Landlord’s rights hereunder unless such waiver shall be in writing. No payment by Tenant or acceptance by Landlord of a lesser amount than shall be due Landlord from Tenant shall be deemed to be anything but payment on account, and the acceptance by Landlord of a check for a lesser amount with an endorsement or statement thereon, or upon a letter accompanying said check, that said lesser amount is payment in full shall not be deemed an accord and satisfaction, and Landlord may accept said check without prejudice to recover the balance due or pursue any other remedy.

Section 13.9 Holdover . If Tenant remains in the Premises beyond the expiration of this Lease at the end of the Lease Term, or sooner following an early termination as provided for herein, such holding over shall not be deemed to create any tenancy, but Tenant shall be a daily Tenant at sufferance only subject to all of Tenant’s obligations set forth herein, but at a Base Rent equal to one and one-half (1  1 2 ) times the Base Rent then most recently in effect and with the continued obligation to pay Additional Rent and other charges provided for under this Lease, with such Base Rent and Additional Rent to be charged on a monthly basis for each calendar month or portion thereof for which Tenant holds over, without proration for a partial calendar month. The acceptance of a purported rent check following termination shall not constitute the creation of a tenancy at will, it being agreed that Tenant’s status shall remain that of a daily Tenant at sufferance, at the aforesaid daily rate. Tenant shall also pay to Landlord all damages, if any, sustained by reason of any such holding over. Otherwise, such holding over shall be on the terms and conditions set forth in this Lease as far as applicable.

Section 13.10 When Lease Becomes Binding . The submission of this document for examination and negotiation does not constitute an offer to lease or a reservation or an option for the Premises, and this document shall become effective and binding, only upon the execution and delivery hereof by both Landlord and Tenant and the receipt by Landlord of the Security Deposit and the first monthly installment of Base Rent ($170,291.67). All negotiations, considerations, representations and understandings between Landlord and Tenant are incorporated herein and may be modified or altered only by agreement in writing between Landlord and Tenant, and no act or omission of any employee or agent of Landlord shall alter, change or modify any of the provisions hereof.

Section 13.11 Recordation . Tenant shall not record this Lease with any registry of deeds or land court, and any such recordation will be void and constitute an Event of Default under this Lease. Landlord shall execute and deliver in connection with the execution of this Lease, and Tenant may record, a notice of this Lease in the form attached as Exhibit H (which form may be amended from time to time to reflect changes in the information contained therein).

Section 13.12 As Is . Subject to performance of the Base Building Work, Tenant represents to Landlord that it has leased the Premises after a full and complete examination of the same, and by its execution and delivery of this Lease, Tenant hereby acknowledges that neither Landlord, nor Landlord’s agents, has made any representation or promises with respect to the Premises, the Building, or the land upon which it stands, and no rights, easements or licenses are acquired by Tenant, by implication or otherwise, except as may be set forth expressly in this Lease.

 

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Section 13.13 Financial Statements; Certain Representations and Warranties .

(a) From time to time at the request of Landlord, Tenant shall provide to Landlord, any actual or potential mortgagee and any actual or potential ground lessor or any representative of any of the foregoing, copies of Tenant’s annual financial statements (audited if available), certified as true and correct by an officer of Tenant; provided that so long as the stock of Tenant is publicly traded, documents on file with the Securities and Exchange Commission and available to Landlord shall satisfy such financial reporting requirements.

(b) Tenant represents and warrants to Landlord, its successors and assigns that: (i) Tenant is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware, and is authorized to transact business in the Commonwealth of Massachusetts; (ii) the execution, delivery and performance of this Lease by Tenant has been duly authorized by the all required corporate action of Tenant; and (iii) this Lease is valid and binding upon the Tenant and is enforceable against Tenant in accordance with the terms hereof.

(c) Landlord represents and warrants to Tenant, its successors and assigns that: (i) Landlord is a nominee trust, validly existing and is authorized to transact business in the Commonwealth of Massachusetts; (ii) the execution, delivery and performance of this Lease by Landlord has been duly authorized by the all required trust action of Landlord; and (iii) this Lease is valid and binding upon the Landlord and is enforceable against Landlord in accordance with the terms hereof.

Section 13.14 Confidentiality .

(a) Tenant acknowledges that the terms under which Landlord has leased the Premises to Tenant (including, without limitation, the rental rate(s), term and other financial and business terms) constitute confidential information of Landlord (“ Landlord’s Confidential Information ”). Tenant shall keep Landlord’s Confidential Information completely confidential; provided that (i) Landlord’s Confidential Information may be disclosed by Tenant to those of its officers, employees, attorneys, accountants, lenders and financial advisors (collectively, “representatives”), and to the representatives of any permitted or prospective subtenant or permitted or prospective assignee, who need to know such information in connection with the use and occupancy of the Premises and for financial reporting and credit related activities (it being understood that Tenant shall inform all such Persons to whom Tenant discloses Landlord’s Confidential Information of the confidential nature of Landlord’s Confidential Information and that such Persons shall be directed by Tenant to treat Landlord’s Confidential Information confidentially in accordance with the terms of this Section), and (ii) unless required by applicable law, any other disclosure of such information may only be made if Landlord consents in writing prior to any such disclosure. Landlord acknowledges that Tenant, as a public company, may be required to make certain disclosures about this Lease, including filing the lease as a material contract, and that such disclosures will not violate this Section 13.14(a).

(b) Landlord acknowledges that, in connection with this Lease, Tenant is furnishing to Landlord financial information regarding Tenant and Tenant’s business, facilities and operations and other confidential information (collectively, “ Tenant’s Confidential Information ”). Landlord covenants and agrees to keep Tenant’s Confidential Information confidential; provided, however, that (i) Tenant’s Confidential Information may be disclosed by Landlord to Landlord’s representatives who need to know such information in connection with Landlord’s business and to Landlord’s lenders, purchasers and investors and prospective lenders, purchasers and investors and their respective representatives (it being understood that Landlord shall inform any such Person to whom Landlord discloses Tenant’s Confidential Information of the confidential nature of Tenant’s Confidential Information and that such Persons shall be directed by Landlord to treat Tenant’s Confidential Information confidentially in accordance with the terms of this Section), and (b) unless required by applicable law, any other disclosure of such information may only be made if Tenant consents in writing prior to any such disclosure.

 

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Section 13.15 Lease Effectiveness Conditions . This Lease is subject to the satisfaction of the following conditions for the benefit of Tenant (collectively, the “ Lease Effectiveness Conditions ”): (a) Union Security Insurance Company consenting in writing to this Lease; (b) Union Security Insurance Company entering into a Subordination, Non-Disturbance and Attornment Agreement with Tenant substantially in the form of Exhibit G-1 hereto or in such other form as shall be reasonably satisfactory to Tenant, to which Landlord shall consent; (c) Parcel B Owner executing and delivering to Tenant an estoppel certificate substantially in the form of Schedule 6.5 hereto or in such other form as shall be reasonably satisfactory to Tenant; and (d) Tenant and Parcel B Owner entering into a letter agreement substantially in the form of Schedule 13.15 hereto or in such other form as shall be reasonably satisfactory to Tenant, in which Landlord shall join for the purposes indicated in Schedule 13.15 hereto. Landlord and Tenant shall proceed diligently, cooperatively and with commercially reasonable efforts to attempt to satisfy the Lease Effectiveness Conditions as soon as practical after the date of this Lease. At the request of Landlord or Tenant at any time that the Lease Effectiveness Conditions have been satisfied, Landlord and Tenant shall confirm in writing the satisfaction of the Lease Effectiveness Conditions. If the Lease Effectiveness Conditions have not been satisfied within 30 days after the date of this Lease, then Tenant may, within five Business Days after expiration of such 30 day period, terminate this Lease by written notice to Landlord, in which event Landlord shall promptly return to Tenant the Security Deposit and the first monthly installment of Base Rent; and if Tenant fails to so terminate this Lease, Tenant shall be deemed to have waived the Lease Effectiveness Conditions that are then unsatisfied.

Section 13.16 Summary of Basic Terms . The Summary of Basic Terms which is affixed to this Lease sets forth certain basic terms and information which is thereafter referred to in the main text of this Lease. Every reference to the Summary of Basic Terms, or to a particular item thereon, shall have the effect of incorporating the Summary, or the particular item thereof, into the main text of this Lease.

Section 13.17 Waiver of Lien . Landlord hereby waives any right to claim a security interest or lien right in Tenant’s property, other than a lien arising from the enforcement of a judgment against Tenant. Landlord hereby agrees to execute a landlord waiver in Landlord’s commercially reasonable form for the benefit of any national banking association or institutional lender of Tenant.

Section 13.18 Announcements . Landlord shall not issue any press release or other statement announcing the execution of this Lease without Tenant’s review and approval, not to be unreasonably withheld, conditioned or approved.

Section 13.19 Force Majeure . As used in this Lease, “Force Majeure” shall mean, collectively and individually, strike, lockout or other labor trouble, fire or other casualty, governmental pre-emption of priorities or other controls in connection with a national or other public emergency or shortages of fuel, supplies or labor, breakdown, accident, or because of war or other emergency (including severe weather emergency), any governmental restriction, inability to obtain or delays in obtaining materials or supplies (exclusive of delays inherent in ordering long lead items), acts of God, acts of terrorism, acts of war or civil insurrection, or in the case of repair or restoration obligations, any cause beyond such party’s reasonable control. With respect to any obligations of Landlord or Tenant under this Lease, neither Landlord nor Tenant shall be liable for failure to furnish or perform the same, nor shall the same constitute a default hereunder, when it is prevented from doing so by reason of Force Majeure; and any measured time period shall be extended by the period during which Landlord or Tenant is so prevented. In no even shall Force Majeure excuse any failure to make payments under this Lease when due.

[execution on following page]

 

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Tenant and Landlord, each by its duly authorized officer, have signed this Lease as of the date first set forth above.

 

TENANT:
INFINITY PHARMACEUTICALS, INC.
By:  

/s/ Adelene Q. Perkins

  Adelene Q. Perkins, President
By:  

/s/ Lawrence E. Bloch

  Lawrence E. Bloch, Treasurer
LANDLORD:
BHX, LLC, as Trustee of 784 Realty Trust
By:  

/s/ Robert A. Schlager

Name:     Robert A. Schlager
Title:   Member
  Duly Authorized

 

44


EXHIBIT A

Property Description


EXHIBIT “A”

A certain lease area in the Commonwealth of Massachusetts, County of Middlesex, City of Cambridge, situated on the easterly side of Memorial Drive and shown as Lease Area on a plan entitled “Lease and Easement Plan, 784 Memorial Drive, Cambridge, MA, Middlesex County” dated December 20, 1999, prepared by Beals and Thomas, Inc. More particularly bounded and described as follows:

Beginning at a point on the easterly side of Memorial Drive said point being northerly approximately 100 feet from the sideline of Pleasant Street, thence running;

 

Northerly by a curve to the right having a radius of 35,622.04 feet and a length of 305.70 feet to a point, said course being by the easterly line of Memorial Drive, thence turning and running;

 

S 84 35 13 E 110.20 feet to a point, thence turning and running;

 

S 05 24 47 W 65.46 feet to a point, thence turning and running;

 

S 84 35 13 E 30.89 feet to a point, thence turning and running;

 

S 05 24 47 W 36.87 feet to a point, thence turning and running;

 

Southeasterly by a curve to the right having a radius of 132.71 feet and a length of 29.31 feet to a point, thence turning and running;

 

S 87 30 45 W 4.69 feet to a point, thence turning and running;

 

Southerly by a curve to the right having a radius of 113.82 feet and a length of 54.88 feet to a point, thence turning and running;

 

S 05 24 47 W 54.66 feet to a point, thence turning and running;

 

N 84 35 13 W 33.98 feet to a point, thence turning and running;

 

S 05 24 47 W 65.53 feet to a point, thence turning and running;

 

N 84 35 13 W 107.15 feet to the point of beginning.

Containing 39,278 square feet more or less.


EXHIBIT B

Site Plan


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EXHIBIT C

Building Floor Plan


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EXHIBIT D

Base Building Work


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INFINITY PHARMACEUTICALS

784 MEMORIAL DRIVE - CAMBRIDGE MA

BASE BUILDING MEP UPGRADES

BUDGET ESTIMATE

     REVISED      8/9/13  

DESCRIPTION

   QTY     UNIT $      LINE SUM      DIV. SUM  

PROJECT REQUIREMENTS

          

TEMP. PROTECTION OF EXISTING FINISHES

     1  LS      3,500         3,500      

CELL PHONE & WIRELESS USAGE

     3  MO      300         900      

FIELD OFFICE SUPPLIES

     3  MO      400         1,200      

PARKING FEES

     12  WKS      320         3,840      

COURIER / OVERNIGHT & POSTAGE

     3  MO      200         600      

MISC. TOOLS & SUPPLIES

     3  MO      600         1,800      

CLEAN & MAINTAIN TOILET FACILITIES

     3  MO      900         2,700      

REPRODUCTION OF CONTRACT DOCUMENTS

     1  LS      3,250         3,250      

GENERAL / DAILY CLEAN UP LABORER

     60  DYS      350         21,000      

SAFETY INSPECTIONS, PROTECTION & BARRICADES

     12  WKS      325         3,900      

DUMPSTERS / DEBRIS REMOVAL

     12  EA      675         8,100      

FINAL CLEANING

     1  ALW      4,200         4,200      
           $ 54,990   
          

 

 

 

SELECTIVE DEMOLITION

          

ACCESS FOR MEP TRADES

     16  DYS      480         7,680      

CONCRETE / ROOF CORING

     1  LS      3,100         3,100      
           $ 10,780   
          

 

 

 

STEEL & MISC. IRON

          

STRUCTURAL STEEL DUNNAGE FOR NEW ROOF TOP BOILERTS

     1  ALW      15,000         15,000      

ALLOWANCE TO EXTEND PENTHOUSE (ASSUME 12 X 14)

     168  SF         100,000      
           $ 115,000   
          

 

 

 

CARPENTRY & FINISHES

          

FINISHES REMOVAL & REPAIRS

     8  LOC      7,750         62,000      

DRYWALL - PAINT - CELING - ROOFING - FINISHES

     1  ALW      12,500         12,500      

MISC. GENERAL CARPENTRY LABOR

     10  DYS      870         8,700      

CAPENTRY MATERIALS ALLOWANCE (ROOF BLOCKING, ETXC.)

     1  ALW      3,000         3,000      
           $ 86,200   
          

 

 

 

THERMAL & MOISTURE PROTECTION

          

FLASH IN DUNNAGE SUPPORTS

     6  EA      225         1,350      

FLASH IN PIPING PENETRATIONS

     12  EA      175         2,100      

FLASH DETAIL AS REQUIRED AT PENTHOUSE

     52  LF      115         5,980      

CAULKING & SEALANTS

     1  LS      3,500         3,500      
           $ 12,930   
          

 

 

 

FIRE PROTECTION

          
             NO WORK   
          

 

 

 


LOGO

INFINITY PHARMACEUTICALS

784 MEMORIAL DRIVE - CAMBRIDGE MA

BASE BUILDING MEP UPGRADES

BUDGET ESTIMATE

 

     REVISED      8/9/13  

DESCRIPTION

   QTY     UNIT $      LINE SUM      DIV. SUM  

PLUMBING

          

BASE BUILDING MISC. UPGRADES

          

REPLACE FITNESS CENTER HOT WATER HEATER + ACCESSORIES

     1  EA         INCL      

REPLACE BASE BUILDING HOT WATER HEATER + ACCESSORIES

     1  LS         INCL      

INSTALL NEW MOP SINK AND BASIN - 2ND FL

     1  LS         INCL      

FURNISH & INSTALL NEW ADA INSULATION AT SINK(2) - 2ND FL

     1  LS         INCL      

FURNISH & INSTALL NEW ADA INSULATION AT SINK(2) - 3RD FL

     1  LS         INCL      

FURNISH & INSTALL NEW ADA INSULATION AT SINK(1) - 4TH FL

     1  LS         INCL      

INSULATE EXISTING ROOF DRAIN - PENTHOUSE

     1  LS         INCL      

BASE BUILDING BATHROOM FIXTURE REPLACEMENT

          

REPLACE EXISTING FIXTURES W/ NEW HIGH EFFICIENCY FIXTURES

     1  LS         INCL      

BASE BUILDING BATHROOM ROUGH REPLACEMENT BACK TO MAIN STACKS

          

REPLACE ROUGH MAINS BACK TO THE STACK

     1  LS         INCL      

PROVIDE NEW 4” GAS MAIN FROM NEW METER TO PENTHOUSE

     1  LS         INCL      

PROVIDE MAKE UP WATER FEED WITH BFP FOR NEW BOILERS

     1  LS         INCL      

DESIGN & ENGINEERING SERVICES

     1  LS         INCL      

SUBCONTRACTOR QUOTE - NSMC

     1  QT      172,734         172,734      
           $ 172,734   
          

 

 

 

HVAC

          

ADD BOILER PLANT TO SERVE (3) AHU’S

          

F & I (2) BOILERS PUMPS + ACCESSORIES

     1  LS         INCL      

F & I NEW HOT WATER COILS IN AIR HANDLERS (3)

     1  LS         INCL      

CONTROLS UPGRADE TO INTERFACE W/ BOILERS PUMPS AHU’S

     1  LS         INCL      

START UP TEST BALANCE

     1  LS         INCL      

DESIGN & ENGINEERING SERVICES

     1  LS         INCL      

SUBCONTRACTOR QUOTE - ESI

     1  QT      568,000         568,000      

DRIVEWAY PATCH & REPAIRS FOR NEW GAS MAIN

     1  ALW      5,000         5,000      

REPLACE EXISTING CONDENSING UNITS - AHU’S TO REMAIN

          

REMOVE & DISPOSE REFRIGERANT

     1  LS         INCL      

F & INSTALL NEW CONDENSING UNITS

     1  LS         INCL      

CONTROLS UPGRADE TO INTERFACE W/ AHU’S

     1  LS         INCL      

START UP TEST BALANCE

     1  LS         INCL      

DESIGN & ENGINEERING SERVICES

     1  LS         INCL      

SUBCONTRACTOR QUOTE - ESI

     1  QT      475,000         475,000      

REPLACE EXISTING FPB’S AND VAV’S

          

77 BOXES ANTICIPATED TO BE CHANGED DURING T.I. SCOPE

     77  EA      EXCLUDED         T.I.      

REPLACE 28 EXISTING BOXES & CONNECT TO NEW CONTROLS

     28  EA      5,600         156,800      
           $ 1,204,800   
          

 

 

 

BUILDING CONTROLS

          

PROVIDE & INSTALL BUILDING BMS SYSTEM FOR NEW SCOPE

     1  LS      188,400         188,400      
           $ 188,400   
          

 

 

 

ELEVATOR

          

ELEVATOR UPGRADES (MOTORS, CONTROLS, FINISHES)  

     1  ALW      180,000         180,000      
           $ 180,000   
          

 

 

 


LOGO

INFINITY PHARMACEUTICALS

784 MEMORIAL DRIVE - CAMBRIDGE MA

BASE BUILDING MEP UPGRADES

BUDGET ESTIMATE

 

     REVISED      8/9/13  

DESCRIPTION

   QTY     UNIT $     LINE SUM      DIV. SUM  

ELECTRICAL

         

BASE BUILING UPGRADES

         

HVAC EQUIPMENT POWER WIRING

     1  LS        INCL      

PLUMBING EQUIPMENT POWER WIRING

     2  EA        INCL      

PENTHOUSE EXPANSION POWER & LIGHTING

     1  LS        INCL      

REPLACE DAMAGED EXIT SIGNS AND EBU’S

     20  EA        INCL      

INFRARED TESTING OF ELECTRICAL EQUIPMENT

     1  LS        INCL      

CORE BATHROOM ELECTRICAL UPGRADES - MEN- WOMENS - 4 FLS

     4  EA        INCL      

FIRE ALARM SYSTEM REPAIRS - REPLACEMENT

     1  LS        INCL      

DESIGN & ENGINEERING

     1  LS        INCL      

SUBCONTRACTOR QUOTE- IES

     1  QT      38,425        38,425      

BASE BUILING LIGHTING UPGRADES

         

REPLACE EXISTING LIGHTING FIXTURES PER FLOOR

       EXCLUDED        T.I.      

REPLACE EXISTING LIGHTING FIXTURE CONTROLS PER FLOOR

       EXCLUDED        T.I.      
          $ 38,425   
         

 

 

 

SUPERVISION & MANAGEMENT

         

PROJECT SUPERINTENDENT

     12  WKS      3,600        43,200      

OFF HOURS SUPERINTENDENT

     4  WKS      3,600        14,400      

PROJECT MANAGER ( 3/5 TIME)

     12  WKS      2,280        27,360      

ADMIN. ASSISTIANT

     12  DAYS      480        5,760      

ACCOUNTING

     12  DAYS      560        6,720      
          $ 97,440   
         

 

 

 

GENERAL CONDITIONS

         

FIELD OFFICE SET UP & SUPPLIES

     3.0  MO      600        1,800      
          $ 1,800   
         

 

 

 

ENGINEERING

         

MEP ENGINEERING

         w/ subs      

STRUCTURAL ENGINEERING

     1  ALW      12,000        12,000      

ARCHITECTURAL SERVICES (PERMIT DRAWING ONLY)

     1  LS      15,000        15,000      

AHA DESIGN REVIEW

     1  ALW      5,000        5,000      

TRG PRECONSTRUCTION / ESTIMATING & PLANNING

     1  LS      7,200        7,200      
            39,200   
         

 

 

 

INSURANCE & PERMITS

         

GENERAL LIABILITY INSURANCE

     1.0  %      22,027        22,027      

CAMBRIDGE BUILDING PERMIT

     1.5  %      33,040        33,040      

P&P BOND COSTS

         EXCLUDED      

BUILDERS RISK INSURANCE

         EXCLUDED      
          $ 55,067   
         

 

 

 

DESIGN CONTINGENCY

     5.0  %      112,888        112,888      
          $ 112,888   
         

 

 

 

OVERHEAD & PROFIT

     5.0  %      118,533        118,533      
          $ 118,533   
         

 

 

 

TOTAL BUDGET  

          $ 2,489,188   
         

 

 

 


LOGO

INFINITY PHARMACEUTICALS

784 MEMORIAL DRIVE - CAMBRIDGE MA

BASE BUILDING MEP UPGRADES

BUDGET ESTIMATE

 

     REVISED    8/9/13

DESCRIPTION

   QTY    UNIT $    LINE SUM    DIV. SUM
           

CLARIFICATIONS

 

1 ESTIMATE IS BASE ON UNION RATES FOR CARPENTRY ONLY - MEP & LABORERS ARE OPEN SHOP
2 SCOPE ASSUMES NSTAR & BUILDING OWNER WILL ALLOW AN EASEMENT FOR NEW GAS SUPPLY LINE TO THE BUILDING


EXHIBIT E

FORM OF LETTER OF CREDIT

                     , 2014

OUR L/C NO.: XXXXXX

 

TO:

BHX, LLC, as Trustee of 784 Realty Trust

c/o The Bulfinch Companies, Inc.

250 First Avenue, Suite 200

Needham, MA 02494

  

APPLICANT:

Infinity Pharmaceuticals, Inc.

780 Memorial Drive

Cambridge, MA 02139

WE HAVE ESTABLISHED OUR IRREVOCABLE STANDBY LETTER OF CREDIT IN YOUR FAVOR AS DETAILED HEREIN SUBJECT TO ISP98

 

DOCUMENTARY CREDIT NUMBER:    XXXXXX
DATE OF ISSUE:                         , 2014
BENEFICIARY:   

BHX, LLC, as Trustee of 784 Realty Trust

c/o The Bulfinch Companies, Inc.

250 First Avenue, Suite 200

Needham, MA 02494

APPLICANT:   

Infinity Pharmaceuticals, Inc.

780 Memorial Drive

Cambridge, MA 02139

DATE AND PLACE OF EXPIRY:   

                     , 2015

AT OUR COUNTERS

DOCUMENTARY CREDIT AMOUNT    USD 1,000,000.00
AVAILABLE WITH:   

JPMORGAN CHASE BANK, N.A

CHICAGO, ILLINOIS USA

BY PAYMENT

ADDITIONAL DETAILS:

WE ARE INFORMED THIS LETTER OF CREDIT IS ISSUED RELATIVE TO THAT CERTAIN LEASE DATED [DATE], INCLUDING ANY AMENDMENTS AND RESTATEMENTS THERETO BETWEEN INFINITY PHARMACEUTICALS, INC., AS TENANT, AND BHX, LLC, AS TRUSTEE OF 784 REALTY TRUST, AS LANDLORD (THE “LEASE”), FOR PREMISES LOCATED AT 784 MEMORIAL DRIVE, CAMBRIDGE, MASSACHUSETTS.


FUNDS UNDER THIS CREDIT ARE AVAILABLE AGAINST YOUR DRAFT(S) AT SIGHT ON JPMORGAN CHASE BANK N.A., MARKED “DRAWN UNDER JPMORGAN CHASE BANK, N.A. LETTER OF CREDIT NO. XXXXXX” ACCOMPANIED BY THE FOLLOWING:

“BENEFICIARY’S SIGNED AND DATED STATEMENT READING AS FOLLOWS:

A DEFAULT HAS OCCURRED UNDER THAT CERTAIN LEASE DATED [DATE], INCLUDING ANY AMENDMENTS AND RESTATEMENTS THERETO, BETWEEN INFINITY PHARMACEUTICALS, INC., AS TENANT, AND BHX, LLC, AS TRUSTEE OF 784 REALTY TRUST, AS LANDLORD.”

OR

“WE ARE IN RECEIPT OF NOTICE FROM JPMORGAN CHASE BANK, N.A. THAT THIS LETTER OF CREDIT WILL NOT BE EXTENDED BEYOND [CURRENT EXPIRY DATE] AND INFINITY PHARMACEUTICALS, INC. HAS FAILED TO SUPPLY ACCEPTABLE REPLACEMENT SECURITY WITHIN THE TIME FRAME SPECIFIED IN THAT CERTAIN LEASE DATED [DATE], INCLUDING ANY AMENDMENTS AND RESTATEMENTS THERETO BETWEEN INFINITY PHARMACEUTICALS, INC. AS TENANT AND BHX, LLC, AS TRUSTEE OF 784 REALTY TRUST, AS LANDLORD (THE “LEASE”).”

IT IS A CONDITION OF THIS LETTER OF CREDIT THAT IT SHALL BE DEEMED AUTOMATICALLY EXTENDED WITHOUT AMENDMENT FOR ONE YEAR FROM THE PRESENT OR ANY FUTURE EXPIRATION DATE, HOWEVER NOT BEYOND (THE “FINAL EXPIRY DATE”),UNLESS AT LEAST SIXTY (60) DAYS PRIOR TO THIS OR ANY FUTURE EXPIRATION DATE WE SHALL SEND NOTICE TO YOU BY REGISTERED MAIL, RETURN RECEIPT REQUESTED, OR BY HAND-DELIVERED COURIER THAT WE ELECT NOT TO CONSIDER THIS LETTER OF CREDIT EXTENDED FOR ANY SUCH ADDITIONAL PERIOD.

IN NO EVENT WILL THE TOTAL OF ALL PAYMENTS PAID HEREUNDER EXCEED U.S. $1,000,000.00.

THIS LETTER OF CREDIT IS TRANSFERABLE, BUT ONLY IN ITS ENTIRETY, AND MAY BE SUCCESSIVELY TRANSFERRED. TRANSFER OF THIS LETTER OF CREDIT SHALL BE EFFECTED BY US UPON YOUR SUBMISSION OF THIS ORIGINAL LETTER OF CREDIT, INCLUDING ALL AMENDMENTS, IF ANY, ACCOMPANIED BY OUR TRANSFER REQUEST FORM DULY COMPLETED AND SIGNED, WITH THE SIGNATURE THEREON AUTHENTICATED BY YOUR BANK. IF YOU WISH TO TRANSFER THE LETTER OF CREDIT, PLEASE CONTACT US FOR THE FORM WHICH WE SHALL PROVIDE TO YOU UPON YOUR REQUEST. IN ANY EVENT, THIS LETTER OF CREDIT MAY NOT BE TRANSFERRED TO ANY PERSON OR ENTITY LISTED IN OR OTHERWISE SUBJECT TO, ANY SANCTION OR EMBARGO UNDER ANY APPLICABLE RESTRICTIONS. CHARGES AND FEES RELATED TO SUCH TRANSFER WILL BE FOR THE ACCOUNT OF THE APPLICANT.

PRESENTATION OF DOCUMENTS BY TELEFACSIMILE (“FAX”) IS ACCEPTABLE, AND MUST BE DIRECTED TO FAX NUMBER 312-954-             , OR ALTERNATELY TO FAX NUMBER 312-954-            UNDER TELEPHONE ADVICE TO 312-954-            , OR ALTERNATELY TO 312-954-            ; PROVIDED THAT SUCH FAX PRESENTATION IS RECEIVED ON OR BEFORE THE EXPIRY

 

2


DATE ON THIS INSTRUMENT IN ACCORDANCE WITH THE TERMS AND CONDITIONS OF THIS LETTER OF CREDIT, IT BEING UNDERSTOOD THAT ANY SUCH FAX PRESENTATION SHALL BE CONSIDERED THE SOLE OPERATIVE INSTRUMENT OF DRAWING, NOT CONTINGENT UPON PRESENTATION OF THE ORIGINAL LETTER OF CREDIT OR ORIGINAL DOCUMENTS WITH RESPECT THERETO.

AS AN ALTERNATIVE TO THE OPTION OF FAX PRESENTATION PROVIDED FOR ABOVE, BENEFICIARY MAY ALSO MAKE PRESENTATION OF DOCUMENTS AT OUR COUNTERS. WE ENGAGE WITH YOU THAT DOCUMENTS PRESENTED UNDER AND IN CONFORMITY WITH THE TERMS AND CONDITIONS OF THIS CREDIT WILL BE DULY HONORED ON PRESENTATION IF PRESENTED ON OR BEFORE THE EXPIRATION AT OUR COUNTERS AT 131 SOUTH DEARBORN STREET, 5 TH FLOOR, MAIL CODE IL1-0236, ATTN: STANDBY LETTER OF CREDIT UNIT, CHICAGO, IL 60603-5506. THE ORIGINAL LETTER OF CREDIT MUST ACCOMPANY THE DOCUMENTS REQUIRED UNDER THIS CREDIT FOR ENDORSEMENT.

IF A DRAWING BY BENEFICIARY HEREUNDER DOES NOT, IN ANY INSTANCE, CONFORM TO THE TERMS AND CONDITIONS OF THIS LETTER OF CREDIT, WE SHALL GIVE BENEFICIARY IMMEDIATE NOTICE THAT THE DRAW DOCUMENTS ARE NOT IN ACCORDANCE WITH THE TERMS AND CONDITIONS OF THIS LETTER OF CREDIT, STATING THE REASONS THEREFOR, AND THAT WE ARE RETURNING THE DOCUMENTS TO BENEFICIARY. UPON BEING NOTIFIED THAT THE DRAW DOCUMENTS ARE NOT IN ACCORDANCE WITH THIS LETTER OF CREDIT, BENEFICIARY MAY ATTEMPT TO CORRECT ANY SUCH NON-CONFORMING DEMAND FOR PAYMENT IF, AND TO THE EXTENT THAT, BENEFICIARY IS ENTITLED AND ABLE TO DO SO WITHIN THE TERMS AND CONDITIONS OF THIS LETTER OF CREDIT.

THIS LETTER OF CREDIT SETS FORTH IN FULL THE TERMS OF OUR UNDERTAKING, AND SUCH UNDERTAKING SHALL NOT IN ANY WAY BE MODIFIED, AMENDED OR AMPLIFIED BY REFERENCE TO ANY DOCUMENT, INSTRUMENT OR AGREEMENT REFERRED TO HEREIN OR IN WHICH THIS LETTER OF CREDIT IS REFERRED TO OR TO WHICH THIS LETTER OF CREDIT RELATES, AND ANY SUCH REFERENCE SHALL NOT BEE DEEMED TO INCORPORATE HEREIN BY REFERENCE ANY DOCUMENT, INSTRUMENT OR AGREEMENT. THE OBLIGATION OF JPMORGAN CHASE BANK, N.A. UNDER THIS LETTER OF CREDIT IS THE INDIVIDUAL OBLIGATION OF JPMORGAN CHASE BANK, N.A. AND IS IN NO WAY CONTINGENT UPON REIMBURSEMENT WITH RESPECT THERETO.

THIS LETTER OF CREDIT IS GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK, AND, EXCEPT AS OTHERWISE EXPRESSLY STATED HEREIN, TO THE INTERNATIONAL STANDBY PRACTICES, ICC PUBLICATION NO. 590 (THE “ISP98”), AND IN THE EVENT OF ANY CONFLICT, THE LAWS OF THE STATE OF NEW YORK WILL CONTROL, WITHOUT REGARD TO PRINCIPLES OF CONFLICT OF LAWS.

 

3


PLEASE ADDRESS ALL CORRESPONDENCE REGARDING THIS LETTER OF CREDIT TO THE ATTENTION OF THE STANDBY LETTER OF CREDIT UNIT, 131 SOUTH DEARBORN STREET, 5 TH FLOOR, MAIL CODE IL1-0236, CHICAGO, IL 60603-5506, INCLUDING THE LETTER OF CREDIT NUMBER MENTIONED ABOVE. FOR TELEPHONE ASSISTANCE, PLEASE CONTACT THE STANDBY CLIENT SERVICE UNIT AT 1-800-634-1969, SELECT OPTION 1, AND HAVE THIS LETTER OF CREDIT NUMBER AVAILABLE.

 

            VERY TRULY YOURS,

            JPMORGAN CHASE BANK, N.A.

 

            AUTHORIZED SIGNER

WE HEREBY AGREE WITH THE FORMAT/LANGUAGE OF THE ABOVE DRAFTED LETTER OF CREDIT, AND WE REQUEST JPMORGAN CHASE BANK, N.A. TO ISSUE THE LETTER OF CREDIT AS ABOVE DRAFTED.

 

INFINITY PHARMACEUTICALS, INC.
BY:    

 

NAME AND TITLE:  

 

 

DATE:  

 

 

4


EXHIBIT F

NOTICE TO PARCEL B OWNER

                     , 2014

ARE 770/784/790 Memorial Drive LLC

c/o Alexandria Real Estate Equities, Inc.

700 Technology Square, First Floor

Cambridge, MA 02139

 

  Re: Declaration of Easements, Covenants, Conditions and Restrictions, dated December 22, 1999, by 784 Memorial Drive LLC, filed with the Middlesex South Registry District of the Land Court as Document No. 1127474 and recorded in the Middlesex South Registry of Deeds on December 29, 1999, in Book 31008, Page 1, as amended by the First Amendment to Declaration of Easements, Covenants, Conditions and Restrictions, dated September 17, 2001, by 784 Memorial Drive LLC, ARE 770/784/790 Memorial Drive LLC and Landlord, filed with the Middlesex South Registry District of the Land Court as Document No. 1195705 and recorded in the Middlesex South Registry of Deeds in Book 34522, Page 324 (the “ Declaration ”)

Ladies and Gentlemen:

BHX, LLC, a Massachusetts limited liability company, as Trustee of 784 Realty Trust, under Declaration of Trust dated December 21, 1999, recorded with the Middlesex South Registry of Deeds on December 29, 1999 as Instrument No. 827, and filed with the Middlesex Registry District of the Land Court on December 29, 1999 as Document No. 1127477 (“ Parcel A Owner ”), is the Parcel A Party, as defined in the Declaration.

Parcel A Owner has leased all of the rentable area on Parcel A, as defined in the Declaration, to Infinity Pharmaceuticals, Inc., a Delaware corporation (“ Tenant ”), pursuant to a Lease dated September     , 2014 by Parcel A Owner and Tenant. Parcel A Owner hereby designates Tenant as a Parcel A Designated Tenant, as defined in the Declaration, and as a Parcel A Parking Tenant, as defined in the Declaration, with respect to 105 parking spaces.

The notice address for Tenant is:

Infinity Pharmaceuticals, Inc.

780 Memorial Drive

Cambridge, MA 02139

Attention: Chief Executive Officer

Tenant may change such notice address by written notice given to you.

 

BHX, LLC, as Trustee of 784 Realty Trust
By:  

 

Name:  

 

Title:  

 


EXHIBIT G-1

[Loan Number:             ]

SUBORDINATION, NON-DISTURBANCE

AND ATTORNMENT AGREEMENT

THIS AGREEMENT made as of September     , 2014, by and between UNION SECURITY INSURANCE COMPANY , an Iowa corporation (hereinafter referred to as “Lender”), and INFINITY PHARMACEUTICALS, INC. , a Delaware corporation (hereinafter referred to as “Tenant”).

W I T N E S S E T H :

WHEREAS , BHX, LLC, a Massachusetts limited liability company, as the sole Trustee of 784 Realty Trust, a Massachusetts nominee trust (hereinafter referred to as “Landlord”), and Tenant have entered into a certain lease (as it may be amended, hereinafter referred to as the “Lease”) dated on or about even date herewith, relating to the premises described in Exhibit “A” attached hereto and by this reference made a part hereof (hereinafter referred to as the “Premises”); and

WHEREAS , Lender has made a loan (the “Loan”) to Landlord in the original principal amount of $8,200,000 secured by a Mortgage and Security Agreement dated November 29, 2005, recorded with the Middlesex South Registry of Deeds in Book             , Page             , and filed with the Middlesex South Registry District of the Land Court as Document No. 1395819 (hereinafter referred to as the “Mortgage”); and

WHEREAS , as a condition to making the Loan, Lender has required that Landlord assign to Lender the Lease and all rents, issues and profits from the Lease and from the Premises, pursuant to that certain Assignment of Leases and Rents dated November 29, 2005, recorded with the Middlesex South Registry of Deeds in Book             , Page             , and filed with the Middlesex South Registry District of the Land Court as Document No. 1395820 (hereinafter referred to as the “Assignment”); and

WHEREAS , Tenant has agreed that the Lease shall be subject and subordinate to the Mortgage held by Lender, provided Tenant is assured of continued occupancy of the Premises under the terms of the Lease and subject to the terms of this Agreement; and

WHEREAS, the parties hereto desire to set forth their agreement as hereinafter set forth.

NOW, THEREFORE , for and in consideration of the mutual covenants herein contained, the sum of Ten Dollars ($10.00) and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged by each party hereto, and notwithstanding anything in the Lease to the contrary, it is hereby agreed as follows:

1. Lease Subordinate . Lender and Tenant do hereby covenant and agree that the Lease is and shall continue to be subject and subordinate in all respects to the lien of the Mortgage and any renewals, modifications, consolidations, replacements, increases in amount and extensions thereof.

2. Non-Disturbance . Lender does hereby agree with Tenant that so long as Tenant is not in default under the Lease (beyond any period expressly given Tenant under the Lease to cure any such default) in any manner which would entitle Landlord to terminate the Lease or would cause, without any further action of Landlord, the termination of the Lease or would entitle Landlord to dispossess Tenant thereunder, then:


(i) Lender will take no action which will interfere with or disturb Tenant’s possession or use of the Premises or other rights under the Lease; and

(ii) in the event Lender or its successor or assign (Lender and any such successor or assign is herein referred to as the “Successor Landlord”) becomes the owner of (or otherwise is in possession of) the Premises by foreclosure (judicial or non-judicial), exercise of a power of sale or other enforcement right under the Mortgage, exercise of the rights of a mortgagee in possession pursuant to the Mortgage or the Assignment pursuant to a receivership or otherwise, conveyance in lieu of foreclosure or other exercise of Lender’s remedies pursuant to the Mortgage, the Assignment or any other documents exercised in connection therewith (any or all of the foregoing hereinafter referred to as a “Foreclosure”), neither the Lease nor any of Tenant’s rights pursuant to the Lease shall be extinguished by reason of such Successor Landlord acquiring the interest of Landlord or coming into the possession of, or acquiring title to, the Premises by reason of such Foreclosure.

In any Foreclosure, Lender shall not join Tenant as a party in any action or proceeding brought pursuant to the Mortgage in any manner which would alter, disturb or invalidate Tenant’s rights to possess and use the Premises pursuant to the terms of the Lease, as the terms of the Lease are amended by this Agreement. In the event of a Foreclosure, the Successor Landlord shall recognize Tenant as the tenant of the Premises for the remainder of the term of the Lease in accordance with the provisions thereof, as the terms of the Lease are modified by this Agreement. Notwithstanding anything to the contrary hereinabove contained, (a) any interest of Tenant in an option or other right (including any right of first offer or right of first refusal) to purchase all or any part of the Premises contained in the Lease is specifically subordinated to the rights of Lender under the terms of the Mortgage and such option or right shall not be binding upon Lender or any Successor Landlord, and (b) Lender does not intend by this Agreement to waive, negate or alter any covenant or agreement in the Lease, if any, which provides Landlord an option to cancel the Lease independent of any default on the part of Tenant.

3. Lease Obligations Upon Foreclosure . Upon any Foreclosure, all rights and obligations under the Lease shall continue as though the interest of Landlord had not terminated or such Foreclosure had not occurred, and, except as otherwise set forth herein, Tenant shall have the same remedies under the Lease against the Successor Landlord for the breach of the Lease that Tenant would have had against Landlord if the Successor Landlord had not succeeded to the interest of Landlord; provided, however, that the Successor Landlord shall not be:

(a) liable for any act or omission of any prior landlord (including Landlord), provided that the foregoing shall not be deemed to relieve Successor Landlord from the obligation to perform any obligation of Landlord under the Lease which remains unperformed at the time that Successor Landlord succeeds to the interest of Landlord under the Lease; or

(b) subject to any offsets or defenses which Tenant might have against any prior landlord (including Landlord) (other than offset rights expressly provided under the Lease); or

(c) bound by any rent or additional rent which Tenant might have paid under the Lease to any prior landlord (including Landlord) more than thirty (30) days in advance of the due date under the Lease; or

 

2


(d) bound by any amendment or modification of the Lease that shortens the term or reduces the rent payable thereunder made without the written consent of Lender; or

(e) obligated to cure any defaults under the Lease of any prior landlord (including Landlord) unless Tenant has provided Lender with written notice of such default in accordance with Sections 6 and 10 of this Agreement; or

(f) obligated to make any capital improvements to the Premises or the leased premises which any prior landlord (including Landlord) has agreed to make but not completed (provided that nothing in this sentence shall be deemed to relieve any Successor Landlord of its obligation to repair and maintain the Premises as provided under the Lease); or

(g) responsible for security deposits unless paid over to Lender.

4. Attornment . In the event that a Successor Landlord acquires title to the Premises through Foreclosure, (a) the Lease and all of the rights of Landlord pursuant to the Lease shall remain in full force and effect, (b) Tenant shall be bound to the Successor Landlord under all of the provisions of the Lease for the balance of the term thereof (including any extensions or renewals thereof which may be effected in accordance with any options contained in the Lease) with the same force and effect as if the Successor Landlord was the original landlord under the Lease, and (c) Tenant shall attorn to and recognize the Successor Landlord as its landlord under the Lease as aforesaid. Tenant further agrees to attorn to: (i) Lender when in possession of the Premises pursuant to Lender’s rights under the Mortgage or the Assignment; and (ii) any receiver appointed in an action or proceeding to foreclose the Mortgage or otherwise pursuant to Lender’s rights under the Mortgage or the Assignment. These provisions of attornment and recognition shall be effective and self-operative and shall operate automatically without execution of any further instruments on the part of either of the parties hereto. Tenant agrees, however, to execute and deliver at any time, and from time to time, upon the request of Landlord, Lender or any Successor Landlord, any reasonable further instrument or certificate which, Landlord, Lender or such Successor Landlord, as the case may be, deems to be reasonably necessary or appropriate in any such Foreclosure proceeding or conveyance or otherwise to evidence such attornment.

5. Tenants Authorized and Directed to Pay Rents to Lender . Tenant acknowledges that Landlord has executed and delivered to Lender the Assignment of the Lease as an inducement to Lender to make the Loan, and Tenant hereby expressly consents to such assignment. Landlord, by execution of the Joinder and Consent to this Agreement, hereby authorizes and directs Tenant or any other or future tenants or occupants of the Premises, upon receipt from Lender (or Lender’s agent) of written notice to the effect that Lender is then the holder of the Note and the Mortgage and that a default exists thereunder or under the Assignment, to pay over to Lender all rents, payments, reimbursements and other amounts due, payable, arising or accruing under the Lease, and to continue so to do until otherwise notified in writing by Lender. Landlord, by execution of the Joinder and Consent to this Agreement, agrees that payment of such amounts to Lender shall be in accordance with the terms of the Lease and that Landlord shall have no right to declare Tenant in default under the Lease on account of such payments made to Lender, notwithstanding any notices or contrary instructions which Landlord or Landlord’s agents may hereafter deliver to Tenant at the time of a default or otherwise. At such time as Tenant receives written notice from Lender or the Successor Landlord stating that Lender or such Successor Landlord has exercised its rights as aforesaid under the Mortgage or the Assignment to receive the rents under the Lease directly from Tenant, Tenant shall thereafter pay the rents under the Lease directly to Lender or Successor Landlord.

6. Notices of Default . So long as the Mortgage remains outstanding and unsatisfied, Tenant will mail or deliver to Lender, at the address and in the manner hereinbelow provided, a copy of all notices of default given to Landlord by Tenant under and pursuant to the terms and provisions of the

 

3


Lease. Lender shall have the period of time permitted Landlord for curing any default under the Lease as therein provided or, if greater, thirty (30) days after receipt by Lender of such notice, during which time it shall have the right, but not any obligation, to remedy such default of Landlord, by paying any taxes and assessments owing by Landlord, making any repairs and improvements, making any deposits or doing any other act or thing required of Landlord by the terms of the Lease; and all payments so made and all things so done and performed by Lender shall be as effective to prevent the rights of Landlord from being forfeited or adversely affected because of any default under the Lease as the same would have been if done and performed by Landlord; provided, however, that if the act or omission does not involve the payment of money from Landlord to Tenant and the nature of the default, act or omission, the requirements of local law or prudent mortgage lending practices require Lender to take possession of, appoint a receiver with respect to, or to foreclose on, or otherwise commence legal proceedings to recover possession of, the Premises in order to effect such remedy and such legal proceedings and consequent remedy cannot reasonably be achieved within the said thirty (30) days, then Lender shall have such further time as is reasonable under the circumstances to effect such remedy (but in any event not to exceed 180 days in the aggregate) provided that Lender shall notify Tenant within thirty (30) days after receipt of Tenant’s notice of Lender’s intention to effect such remedy, and, provided further, that if required under the circumstances, Lender shall institute immediate legal proceedings to appoint a receiver for the Premises or to foreclose on or recover possession of the Premises within said thirty (30) day period and thereafter prosecute said proceedings and remedy with due diligence to completion. In the event that neither Lender nor Landlord cures the default specified in the notice within the time periods specified herein, Tenant shall be entitled to exercise and assert its rights under the Lease against Landlord, but not otherwise. Notwithstanding the foregoing, nothing under this Section 6 or this Agreement shall be deemed to delay, condition or prevent the exercise of Tenant’s express remedies pursuant to Sections 2.5(b), 3.5(e), 6.3, 12.7(b) and 12.7(c) under the Lease on the conditions set forth therein.

7. Landlord Consents . Without the prior written consent of Lender, neither Landlord nor Tenant will (a) enter into any agreement terminating the Lease, (b) cancel the term of, terminate or surrender, the Lease, or accept any cancellation, termination or surrender of the Lease, or (c) assign or sublet all or any part of the Premises, except only pursuant to any assignment or sublease in accordance with the Lease. Nothing in this Section 7 shall prohibit the termination of the Lease by Tenant where expressly permitted under the Lease.

8. Lease Representations . Landlord and Tenant hereby certify to Lender that the Lease has been duly executed by Landlord and Tenant and is in full force and effect; that the Lease has not been modified or amended except as specified herein; that to the knowledge of Landlord and Tenant, no party to the Lease is in default thereunder; that no rent under the Lease has been paid more than thirty (30) days in advance of its due date; and that Tenant, as of this date, to its knowledge, has no charge, lien, offset, defense, current abatement right, counterclaim or other right or claim under the Lease, or otherwise against the rents or other charges due or to become due thereunder.

9. Environmental Provisions . If and to the extent that the Lease contains any environmental covenants, representations, warranties, certifications or indemnifications from Landlord to Tenant, Tenant hereby agrees that all such rights and privileges pursuant to any such provision of the Lease shall continue to be recognized by and binding upon Landlord upon the succession by Successor Landlord to Landlord’s interest in the Lease and in and to the Premises, but shall not be recognized or binding upon Lender or any Successor Landlord, even if Tenant’s possession of the Premises under the Lease is not otherwise disturbed. In the event that Successor Landlord succeeds to Landlord’s interest in the Premises and with respect to the Lease, Successor Landlord agrees that during the period of Successor Landlord’s ownership of the property, Successor Landlord will comply with all federal, state, county and local statutes, laws, regulations, rules, ordinances and codes relating to environmental matters.

 

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10. Insurance Proceeds . For purposes of this Agreement only, Lender agrees that it shall make the amount of all Net Proceeds (as defined in the Mortgage) received by Lender pursuant to the Mortgage available to Landlord for repair and restoration following any fire or other casualty subject only to the following conditions: (a) no Event of Default (as defined in the Lease) shall exist under the Lease, (b) Landlord shall proceed with the repair and restoration of the Premises as nearly as possible to the condition the Premises were in prior to such fire or other casualty promptly after the insurance claims are settled, (c) the Lease shall not have been terminated by reason of such casualty, (d) the Net Proceeds, together with additional funds provided by Landlord if necessary, are sufficient to reconstruct or restore the Premises according to plans and specifications approved by Lender or its Inspecting Engineer (as defined in the Mortgage), which approval shall not be unreasonably withheld or delayed if such plans and specifications substantially conform to the plans for the existing Premises and comply with local building codes and all other applicable laws, ordinances, rules and regulations, and (e) Lender has determined that all approved restoration work can be completed prior to the maturity of the Note or by such earlier date as may be required under the Lease or pursuant to applicable law.

11. Notices . Any and all notices, elections, demands, requests and responses thereto permitted or required to be given under this Agreement shall be in writing, signed by or on behalf of the party giving the same, and shall be deemed to have been properly given and shall be effective upon being either (i) personally delivered or delivered by courier or messenger, (ii) delivered overnight delivery by recognized air courier (such as Federal Express, UPS or Airborne), or (iii) deposited in the United States mail, certified with return receipt requested, in each case with all postage or delivery charges prepaid, addressed to the other party at the address of such other party set forth below or at such other address within the continental United States as such other party may designate by notice specifically designated as a notice of change of address and given in accordance herewith; provided, however, that the time period in which a response to any such notice, election, demand or request must be given shall commence on the date of receipt thereof; and provided further that no notice of change of address shall be effective until the date of receipt thereof. Rejection or other refusal to accept or inability to deliver because of changed address of which no notice has been received shall also constitute receipt.

Any such notice, election, demand, request or response, if given to Lender, shall be addressed as follows:

        Union Security Insurance Company

        c/o Assurant Asset Management

        One Chase Manhattan Plaza

        New York, NY 10005

        Attn: General Counsel; Loan No. [Loan Number:             ]

With a copy to:

        Assurant Asset Management

        One Chase Manhattan Plaza

        New York, New York 10005

        Attn: Senior Vice President - Mortgages; Loan No. [Loan Number:             ]

and, if given to Tenant, shall be addressed as follows:

        Infinity Pharmaceuticals, Inc.

        780 Memorial Drive

        Cambridge, MA 02139

        Attn: Chief Executive Officer

 

5


With a copy to:   DLA Piper LLP (US)

        33 Arch Street

        Boston, MA 01220

        Attn: Geoffrey Howell

and copies of notices to either Lender or Tenant shall be given to Landlord, addressed as follows:

        BHX, LLC, as Trustee of 784 Realty Trust

        c/o The Bulfinch Companies, Inc.

        250 First Avenue, Suite 200

        Needham, MA 02494

        Attn: Robert Schlager

With a copy to:   BHX, LLC, as Trustee of 784 Realty Trust

        c/o The Bulfinch Companies, Inc.

        250 First Avenue, Suite 200

        Needham, MA 02494

        Attn: Mark R. DiOrio

12. Limitation of Liability . Tenant shall look solely to the Premises and the profits, proceeds and awards therefrom for recovery of any judgment or damages from Lender or such other Successor Landlord, and neither Lender or such other Successor Landlord nor any present or future partner of Lender or such other Successor Landlord or of any partnership which is now or hereafter a partner of Lender or such other Successor Landlord (or of any partnership which is now or hereafter a partner of a partner of Lender or such other Successor Landlord) shall have any personal liability, directly or indirectly, under or in connection with the Lease or this Agreement or any amendment or amendments to either thereof made at any time or times, heretofore or hereafter, and Tenant hereby forever and irrevocably waives and releases any and all such personal liability. The limitation of liability provided in this paragraph is in addition to, and not in limitation of, any limitation on liability applicable to Lender or such other Successor Landlord provided by law or by any other contract, agreement or instrument.

13. No Further Subordinations . By execution of the Joinder and Consent to this Agreement, Landlord agrees that, without the prior written consent of Lender, Landlord will not request that Tenant (a) enter into any subordination agreement with any person other than Lender; or (b) agree to attorn to or recognize any purchaser of the Premises at any foreclosure sale under any lien other than a Successor Landlord pursuant to a foreclosure of the Mortgage of Lender (provided, however, that this provision shall not be deemed to constitute Lender’s consent to the placing of any lien other than the Mortgage on the Premises). Any such agreement executed by Tenant at any time shall be entirely subject to the terms of this Agreement and the rights of Lender hereunder.

14. Successors and Assigns . This Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective heirs, legal representatives, successors, successors-in-title and assigns. When used herein, the term “Landlord” refers to Landlord and to any successor to the interest of Landlord under the Lease, the term “Tenant” refers to Tenant and to any successor to the interest of Tenant under the Lease but only to the extent a successor to such interest is permitted under the Lease; and the term “Lender” refers to Lender and any successor to the interest of Lender under the Mortgage and to any purchaser, including Lender, of the Premises at a Foreclosure.

15. Governing Law . This Agreement shall be governed by and construed and interpreted in accordance with the laws of the State in which the Premises is located.

 

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IN WITNESS WHEREOF , the parties hereto have executed this Agreement under seal as of the date first above written.

 

TENANT:

 

INFINITY PHARMACEUTICALS, INC.

 

By:  

 

  Adelene Q. Perkins, President
By:  

 

  Lawrence E. Block, Treasurer

COMMONWEALTH OF MASSACHUSETTS

COUNTY OF MIDDLESEX

On this     day of September, 2014, before me,                     , a Notary Public of Middlesex County, Massachusetts, personally appeared Adelene Q. Perkins, known or identified to me to be the President of Infinity Pharmaceuticals, Inc., a Delaware corporation, and the officer who subscribed the corporate name to the foregoing instrument, and acknowledged to me that she executed the same in the name of such corporation.

IN WITNESS WHEREOF, I have set my hand and affixed my official notarial stamp or seal, the day and year in this certificate first above written.

 

My Commission Expires:

 

  

 

Notary Public

 

                             [NOTARIAL SEAL]

  

COMMONWEALTH OF MASSACHUSETTS

COUNTY OF MIDDLESEX

On this     day of September, 2014, before me,                     , a Notary Public of Middlesex County, Massachusetts, personally appeared Lawrence E. Bloch, known or identified to me to be the Treasurer of Infinity Pharmaceuticals, Inc., a Delaware corporation, and the officer who subscribed the corporate name to the foregoing instrument, and acknowledged to me that he executed the same in the name of such corporation.

IN WITNESS WHEREOF, I have set my hand and affixed my official notarial stamp or seal, the day and year in this certificate first above written.

 

My Commission Expires:

 

  

 

Notary Public

 

                             [NOTARIAL SEAL]

  

 

7


LENDER:

 

UNION SECURITY INSURANCE COMPANY

By:  

 

      Name:  

 

      Title:  

 

STATE OF NEW YORK

COUNTY OF NEW YORK

On this     day of September, 2014, before me,                     , a Notary Public of New York County, New York, personally appeared                     , known or identified to me to be the                     of Union Security Insurance Company, an Iowa corporation, and the officer who subscribed the corporate name to the foregoing instrument, and acknowledged to me that he executed the same in the name of such corporation.

IN WITNESS WHEREOF, I have set my hand and affixed my official notarial stamp or seal, the day and year in this certificate first above written.

 

My Commission Expires:

 

  

 

Notary Public

 

                             [NOTARIAL SEAL]

  

 

8


JOINDER AND CONSENT

The undersigned, BHX, LLC, a Massachusetts limited liability company, as the sole Trustee of 784 Realty Trust, a Massachusetts nominee trust, referred to as “Landlord” in the foregoing Subordination, Non-Disturbance and Attornment Agreement, does hereby join in and consent to the terms of the foregoing Subordination, Non-Disturbance and Attornment Agreement for the purpose of evidencing and confirming the Landlord’s agreements, covenants and acknowledgments contained in the foregoing Subordination, Non-Disturbance and Attornment Agreement.

IN WITNESS WHEREOF, the undersigned has executed this Joinder and Consent under seal as of the date of the foregoing Subordination, Non-Disturbance and Attornment Agreement as set forth above.

 

LANDLORD:

 

BHX, LLC, as Trustee of 784 Realty Trust

By:  

 

      Name:  

 

      Title:  

 

ACKNOWLEDGMENT

COMMONWEALTH OF MASSACHUSETTS

COUNTY OF NORFOLK

On this     day of September, 2014, before me,                     , a Notary Public of Norfolk County, Massachusetts, personally appeared                     , known or identified to me to be the                     of BHX, LLC, a Massachusetts limited liability company, which is the sole Trustee of 784 Realty Trust, a Massachusetts nominee trust, who subscribed the limited liability company and trust name to the foregoing instrument, and acknowledged to me that he executed the same in the name of such limited liability company and trust.

IN WITNESS WHEREOF, I have set my hand and affixed my official notarial stamp or seal, the day and year in this certificate first above written.

 

My Commission Expires:   

 

Notary Public

 

                             [NOTARIAL SEAL]

  

 

9


EXHIBIT G-2

SUBORDINATION, NON-DISTURBANCE AND ATTORNMENT AGREEMENT


EXHIBIT H

NOTICE OF LEASE

In accordance with the provisions of Massachusetts General Laws, Chapter 183, Section 4, as amended, notice is hereby given of the following lease (“Lease”):

 

LANDLORD :    BHX, LLC, a Massachusetts limited liability company, as Trustee of 784 Realty Trust, whose mailing address is c/o The Bulfinch Companies, Inc., First Needham Place, 250 First Avenue, Suite 200, Needham, MA 02494.
TENANT :    Infinity Pharmaceuticals, Inc., a Delaware corporation, whose mailing address is 780 Memorial Drive, Cambridge, MA 02139.
DATE OF EXECUTION OF LEASE :    September     , 2014.
DESCRIPTION OF PREMISES :    All of the leasable space in the building located on the land described on Exhibit A hereto, which land and building are located at and commonly known as 784 Memorial Drive, Cambridge, MA.
TERM OF LEASE :    The period commencing on November 1, 2014 and expiring on March 31, 2025.
OPTIONS TO EXTEND :    Tenant has the option to extend the term for up to two periods of five years each.

This document is executed pursuant to the Lease and is not intended to vary any of the terms and conditions of the Lease.

This Notice of Lease may be executed in multiple counterparts, each of which shall be an original, but all of which, taken together, will constitute one and the same instrument.

EXECUTED as a sealed instrument this     day of September, 2014.

 

BHX, LLC, as Trustee of 784 Realty Trust
By:  

 

Name:  

 

Title:  

 

INFINITY PHARMACEUTICALS, INC.
By:  

 

Name:  

 

Title:  

 


COMMONWEALTH OF MASSACHUSETTS

Norfolk, ss.

On this     day of September, 2014, before me, the undersigned notary public, personally appeared                     , as                     of BHX, LLC, as Trustee of 784 Realty Trust, proved to me through satisfactory evidence of identification, which were                     , to be the person whose name is signed on the preceding or attached document, and acknowledged to me that he signed it voluntarily for its stated purpose.

 

 

Notary Public

My Commission Expires:  

 

COMMONWEALTH OF MASSACHUSETTS

Middlesex, ss.

On this     day of September, 2014, before me, the undersigned notary public, personally appeared                     , as                     of Infinity Pharmaceuticals, Inc., proved to me through satisfactory evidence of identification, which were                     , to be the person whose name is signed on the preceding or attached document, and acknowledged to me that he signed it voluntarily for its stated purpose.

 

 

Notary Public

My Commission Expires:  

 

 

2


SCHEDULE 2.1

ENCUMBRANCES

 

1. Slope easements as set forth in deed from Dover Stamping Company to the City of Cambridge dated March 19, 1891, recorded in Book 2545, Page 441.

 

2. The Declaration.

 

3. Covenant by 784 Memorial Drive, LLC recorded with the Middlesex South Registry of Deeds in Book 31728, Page 298, and filed with the Middlesex South Registry District of the Land Court as Document No. 1146951.

 

4. Façade Preservation Easement dated December 27, 1999 recorded with the Middlesex South Registry of Deeds in Book 33459, Page 82, and filed with the Middlesex South Registry District of the Land Court as Document No. 1180200.

 

5. Reservation of rights set forth in Deed recorded with the Middlesex South Registry of Deeds in Book 32736, Page 514, and filed with the Middlesex South Registry District of the Land Court as Document No. 1168772.

 

6. Easement to Cambridge Electric Light Company dated August 7, 2001, recorded in the Middlesex South Registry of Deeds in Book 33495, Page 399, and filed with the Middlesex South Registry District of the Land Court as Document No. 1180726.

 

7. Easement to NSTAR Gas Company dated August 2, 2001, recorded in the Middlesex South Registry of Deeds in Book 33742, Page 201, and filed with the Middlesex South Registry District of the Land Court as Document No. 1184536.


SCHEDULE 3.2(b)

PROGRAMMING ELEMENTS FOR TENANT IMPROVEMENTS

The office renovation proposal is inclusive of the 1 st , 2 nd , 3 rd and 4th floor of the 784 Memorial Drive building.

Office Seating Areas:

 

    Demolition will include furnishing, installation and removal of temporary protection as required as well as demolition and removal of walls, floors and ceilings as required by design plans.

 

    Sprinkler system will be reworked as required by design plans.

 

    Existing offices will be removed to create open office environment and allow light to penetrate to the middle of occupied floors.

 

    Smaller offices may be created by leaving partial walls in place and finishing with drywall/plaster, glass or DIRTT or other demountable walls.

 

    VAV and fan powered boxes not replaced (to the extent not part of the Base Building Work) will be replaced and wired to central building management system.

 

    Lighting will be upgraded as required by design plans.

 

    Data and electrical wiring will be installed as required by design plans.

 

    Small kitchen areas, photocopy areas or other utility spaces may be created or renovated.

 

    Materials used may include drywall and plaster, glass or wood and finished according to the design plans.

 

    Ceiling grid will be replaced and new ceiling tiles installed.

 

    New flooring will be installed, to include carpet, vinyl, VCT or tile.

 

    Plaster walls will be painted.

 

    New window blinds will be installed.

Conference Rooms:

 

    Demolition will include furnishing, installation and removal of temporary protection as required as well as demolition and removal of walls, floors and ceilings as required by design plans.

 

    Floor boxes may be installed which will contain electrical power and data.

 

    Accessories installed may include wall mounted computer monitors, ceiling mounted screens and projectors.

 

    Telephone conferencing systems may be installed.

 

    VAV and fan powered boxes (to the extent not replaced in the Base Building Work) will be replaced and wired to central building management system.

 

    Lighting will be upgraded as required by design plans.

 

    Data and electrical wiring will be installed as required by design plans.

 

    Materials used may include drywall and plaster, glass or wood and finished according to the design plans.

 

    Ceiling grid will be replaced and new ceiling tiles installed.

 

    New flooring will be installed, to include carpet, vinyl, vct or tile.


    Plaster walls will be painted.

 

    New window blinds will be installed.

Common Areas and Lobby:

 

    Demolition will include furnishing, installation and removal of temporary protection as required as well as demolition and removal of walls, floors and ceilings as required by design plans.

 

    Finishes may be refurbished or replaced.

 

    VAV and fan powered boxes (to the extent not replaced in the Base Building Work) will be replaced and wired to central building management system.

 

    Lighting will be upgraded as required by design plans. Data and electrical wiring will be installed as required by design plans.

 

    Materials used may include drywall and plaster, glass or wood and finished according to the design plans.

 

    Ceiling grid will be replaced and new ceiling tiles installed.

 

    New flooring may be installed, to include carpet, vinyl, vct or tile.

 

    Plaster walls will be painted.

 

    New window blinds will be installed.

Cafeteria:

Proposals for cafeteria space include areas on the first and fourth floor. The proposed first floor area would include existing exterior door which exits to Quarter Acre Park. The proposed fourth floor area would allow for use of the exterior roof deck. Cafeteria may include a commercial grade kitchen which would be installed in compliance with applicable building code.

 

    VAV and fan powered boxes (to the extent not replaced in the Base Building Work) will be replaced and wired to central building management system.

 

    Lighting will be upgraded as required by design plans. Data and electrical wiring will be installed as required by design plans.

 

    Materials used may include drywall and plaster, glass or wood and finished according to the design plans.

 

    Ceiling grid will be replaced and new ceiling tiles installed.

 

    New flooring will be installed, to include carpet, vinyl, vct or tile.

 

    Plaster walls will be painted.

 

    New window blinds will be installed.

 

2


SCHEDULE 3.2(c)

APPROVED CONTRACTORS FOR TI WORK

Architect

Olson-Lewis

Plumbing Sole Sourcing - Design Build, including engineering

North Shore Mechanical Contractors Danvers MA

HVAC Sole Sourcing - Design Build, including engineering

Environmental Systems Inc. Attleboro MA

Electrical Sole Sourcing - Design Build, including engineering

Interstate Electrical Services N. Billerica MA

Selective Demolition

A1 Concrete Cutting & Construction Norton MA

USA Demolition Woburn MA

Misc Metal

Lawton Welding Co., Inc. Topsfield MA

Weiss Sheet Metal Avon MA

AG Industries N. Attleboro Ma

Glass/Glazing

Wayside Glass & Mirror Marlboro MA

Salem Glass Salem MA

Doors, Frames and Hardware

Commercial Door Shrewsbury MA

Galeno & Associates South Easton MA

O’Connor Door Needham MA

Gypsum Board Assemblies/Framing

EMR Drywall Salem MA

Clifford & Galvin W. Bridgewater MA

Mass Acoustics Natick MA

NE Finish Systems Salem NH

Acoustical Ceilings

The Cheviot Corporation Needham Heights MA

K & K Acoustical Ceilings Tewksbury MA

Mass Acoustics Natick MA

Resilient Flooring

Allegheny Contract Flooring Winchester MA

Business Interiors Floorcovering, Inc. Woburn MA

E-Floors Dedham MA

Painting

J&M Professional Painting Everett MA

Francis E. Kenney Woburn MA

Paint Systems Salem NH

John M. Kennedy Dorchester MA

M.L. McDonald Co., Inc. Watertown MA


Fire Protection

Cameron Fire Protection Engineerin East Gouglas MA

American Plumbing & Heating Corporation Norwell MA

Cannistraro, LLC., J.C. Watertown MA

Noremac Sprinkler

 

2


SCHEDULE 5.3

ENVIRONMENTAL REPORTS

Preliminary Environmental Site Assessment by GEI Consultants, Inc. dated November 4, 1999.

Phase I Environmental Site Assessment Update by GEI Consultants, Inc. dated September 17, 2004.

Phase I Environmental Site Assessment by GZA GeoEnvironmental, Inc. dated November 8, 2005.

Lead Based Paint Assessment by GZA GeoEnvironmental, Inc. dated May 5, 2004.


SCHEDULE 6.1(b)

SPECIFICATIONS FOR BUILDING SYSTEMS

Existing:

PLUMBING

 

    6” sanitary waste discharge line serving the Building and connected to City sewer. A secondary 4” waste line is capped for future use.

 

    Sanitary Sewer stacks rise in several locations to serve the above floor levels:

 

    Column X1/Row XD 4” Sanitary waste stack rise

 

    Column X5/Row XD 5” Sanitary waste stack & 4” Vent stack (Main toilet cores)

 

    Column X14-X15/Rows XC-XD 4” sanitary waste stack and 3” vent stack rise

 

    Column 6.5/Row E 4” sanitary waste stack rise (addition area)

 

    4” Waste line (above crawl space) serves the mechanical floor drains

 

    Domestic water line (4”) serving the Premises with supply from the municipal provider or MWRA, as applicable

 

    Building served by 2” meter (capable of 160gom)

 

    Mechanical room 120 has a 1” secondary backflow preventer for HVAC usage

 

    Service reduces after meter to 3” and exits mechanical room 120 to serve Premises

 

    A 2-1/2” CW riser serving core toilets

 

    Domestic hot water serving the Premises generated in mechanical room 177

 

    Heat domestic hot water to 140*f use “master” mix valve to temper down to 120*f

 

    Additional Sanitary waste & Domestic cold water notables each floor level

 

    1 st floor Wet Column – located col. X14/XC – services avail. 4” W, 3” V, 2” DCW

 

    (8)  3 4 ” WALL HYDRANT UNITS on exterior of main building & addition

 

    1 st floor – 2-1/2” DCW riser for core toilets, rises col. X5/XD

 

    1 st floor – 1-1/4” DHW &  3 4 ” DCW risers located in #162 lavatory wet wall & a  3 4 ” DHW & DCW risers located in #161 lavatory wet wall.

 

    2 nd floor Wet Column – located col. X14/XC – services avail. 4” W, 3” V, 2” DCW

 

    3 rd floor Wet Column – located col. X12/XC – services avail. 4” W, 3” V, 2” DCW

 

    4 th floor Wet Column – located col. X12/XC – services avail. 4” W, 3” V, 2” DCW

 

    Water and sewer service shall be available to Tenant on a 24-hour, 7 day a week basis.

ELECTRICAL

 

    480Y/277 volt (office) feeders to support loads on all floors on demand, 24-hour, 7 days a week. The feeders have been sized to provide 20.0 watts per useable square foot to support tenant’s lighting, receptacle loads, fan power terminal units / VAV boxes, and miscellaneous electrical loads.

 

    The primary HVAC systems are served by a 600 amp 480Y/277 volt feeder to the penthouse distribution panel. Renovations and/or replacements will be served from the same sources on demand, 24-hour, 7 days a week.

HVAC

 

    The office floors throughout the Premises are heated and air conditioned utilizing a vav system.

 

    Three air handlers totaling 57,700 cfm and 200 tons of associated cooling.


TELECOMMUNICATIONS

The Building is served by telecommunications conduits from the property line to the Main Telecommunications Demarcation room in basement and one (1) telecommunications closet per floor, equipped with sleeves connecting to the main telecommunications room.

LIFE SAFETY

The building is equipped with an Edwards System Technology EST2 microprocessor-based multiplex, addressable fire alarm system with audible and visual occupant notification and municipal reporting. Such system may be improved as part of the Base Building Work.

ELEVATOR

Single passenger elevator manufactured by Fujitec America, Inc.

 

    Capacity 3500 Pounds

 

    Speed 125 Feet per Minute

The following services to be provided with the completion of the base building work:

PLUMBING

 

    Natural gas will be provided to serve the new boiler system

HVAC

The HVAC system will be capable of maintaining the following conditions:

Ouside summer condition 91 DegFdb/73 DegFwb Outside winter condition 6 degrees Interior design 75 DegF +/- 2

 

    A boiler plant will heat the building during morning warm up and unoccupied cycles. A hot water pipe distribution system shall be piped to three existing air handlers, or at the Air handlers duct main.

 

    A central control system will service the hot water system including boilers, pumps, the existing air handlers, and fans and will be expandable to provide new DDC controls to all new tenant fit up requirements.

ELEVATOR

Single passenger elevator as may be installed as part of the Base Building Work.

 

2


SCHEDULE 6.1(f)

JANITORIAL SCHEDULE

 

DAILY    COMMON AREAS, OPEN OFFICES, CONFERENCE ROOMS, LOBBY, RECEPTION
1.    Empty wastebaskets, recycle bins and other refuse and transport to designated areas and provide replacement.
2.    Clean and sanitize drinking fountains.
3.    Dust empty desktops and conference room tables.
4.    Clean counter tops.
5.    Spot clean tenant’s interior glass partitions and doors.
6.    Sweep/vacuum and dust stairways.
7.    Remove fingerprints from doors, frames, light switches, kick and push plates, handles.
8.    All building lobby glass doors cleaned nightly and building side lights spot cleaned.
9.    Empty exterior trash.
10.    Clean all baseboard ledges, moldings, directory, depositories and window frames.
11.    Clean lobby sign.
12.    Clean and polish anodized metal finishes.
13.    Clean all entry thresholds.
14.    Dust all mullions and sills and other surfaces up to 70” high.
15.    Vacuum all carpeted areas.
16.    Wet mop all uncarpeted stairwells, landings and clean handrails.
DAILY    CAFETERIA/KITCHEN AREA
1.    Empty all containers and disposal. Sanitize interior and provide liners.
2.    Wash and sanitize exterior of all containers.
3.    Clean and sanitize drinking fountains and counter tops.
4.    Spot Clean interior glass in partitions and doors.
5.    Remove all fingerprints from doors, frames, light switches, kick and push plates, handles.
6.    Nightly cleaning of kitchen areas additionally includes: Tables, Chairs, Counters, Sinks, Floors, Spot Clean Walls.
7.    Clean interior and exterior of microwave ovens in common kitchen areas
8.    Clean exterior of refrigerators.
DAILY    ELEVATORS
1.    Wipe down and polish all metal and wooden surfaces.
2.    Vacuum carpet.
3.    Spot clean carpet.
4.    Clean/vacuum elevator door trackways.
5.    Spot clean all doors and frames.
6.    Dust and clean entire interior and exterior of cabs including saddles.


DAILY    RESTROOMS and SHOWER ROOMS
1.    Clean, sanitize and polish all vitreous fixtures including toilet bowls, urinals and hand basins.
2.    Clean and sanitize all flush rings, drain and overflow outlets.
3.    Clean and polish all chrome fittings.
4.    Clean and sanitize toilet seats (both sides).
5.    Clean and polish all glass mirrors.
6.    Wash and sanitize exterior of all containers
7.    Damp mop floor area with germicidal solution.
8.    Spot clean metal partitions.
9.    Remove spots, stains, splashes from wall area adjacent to hand basins.
10.    Refill all dispensers to normal limits – soap, toilet tissue, paper towels, seat holders. Supplies to be furnished by landlord. Paper towels must be filled to capacity each evening in proper alignment so as to allow for proper disbursement.
11.    Remove fingerprints from doors, frames, light switches, kick and push plates, handles.
12.    Check operation of soap and napkin dispensers.
13.    Clean janitor’s closet walls, floor and sink.
14.    Wash and sanitize metal partitions.
DAILY    FLOORS – VCT TILE, MARBLE, GRANITE
1.    Dust mop or sweep floors.
2.    Damp mop only with cool, fresh water.
3.    Remove all spills, smears, etc., that do not come off in sweeping & mopping.
DAILY    FLOORS – CARPET
1.    Vacuum all rugs and carpet areas including open areas. Remove any gum, staple, paper clip, and tar.
2.    Spot clean stains with carpet stain remover as per manufacturer specifications.
3.    Clean weather mats with a vacuum and damp wipe vinyl edges to remove all dust when mats are out for inclement weather.
DAILY    GENERAL
1.    Leave notice on any observed regularities in daily log book (i. e. defective plumbing, unlocked doors, lights left on, inventory requirements, rest room supplies).
2.    Turn off lights except those to be left on. Close all doors.
3.    Report evacuation of building to appropriate personnel.
4.    Notify designated personnel of any emergency or security situation.
5.   

Complete “Security log” in accordance with Tenant’s procedure.

Note: Tenant hallway doors are to remain locked during cleaning.

6.    Wet mop all uncarpeted stairwells, landings and handrails.
WEEKLY    COMMON AREAS, OFFICES, CONFERENCE ROOMS, LOBBY, RECEPTION
1.    Dust all furniture including desks, chairs and tables.
2.    Dust all exposed filing cabinets, bookcases and shelves.
3.    Low dust all horizontal surfaces to hand height (70”) including shelves, moldings and ledges.

 

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4.    High dust above hand heights all horizontal surfaces, including shelves, moldings and ledges.
5.    Remove spots, stains, marks to hand height (70”).
6.    Clean all common area HVAC diffusers as needed.
7.    Clean all public telephones in phone booths, conference rooms and ‘huddle’ rooms.
8.    Spray buff open areas including kneeholes of desks.
9.    Damp wipe all horizontal surfaces, including conference room tables and empty desks.
WEEKLY    RESTROOMS AND SHOWERS
1.    Dust metal partitions
2.    Low dust all horizontal surfaces to hand height including sills, shelves, moldings, frames, ledges, ducts and heating outlets, etc.
3.    High dust above hand heights all horizontal surfaces, including shelves, moldings and ledges.
4.    Dust all furniture including tables, chairs, etc.
5.    Clean and disinfect floor drains and polish chrome.
6.    Pour water/disinfectant into floor drains.
WEEKLY    CAFETERIA/KITCHEN AREA
1.    Low dust all horizontal surfaces to hand height including sills, shelves, moldings, frames, ledges, ducts and heating outlets, etc.
2.    High dust above hand heights all horizontal surfaces, including shelves, moldings, ledges, pipes, ducts, heating outlets, etc.
3.    Clean interior and exterior of all toaster ovens in common area kitchen areas.
WEEKLY    FLOORS – RESILENT.
1.   

Burnish and restore vinyl tile flooring in kitchen areas and cafeteria.

Sweep and mop loading dock area.

WEEKLY    GENERAL
1.    Customer service visit/walkthrough.
MONTHLY    COMMON AREAS OFFICES, CONFERENCE ROOMS, LOBBY, RECEPTION
1.    Clean and polish bright metal to hand height.
2.    Remove dust and cobwebs from ceiling tiles.
3.    Vacuum diffuser outlets in ceiling.
4.    Hand dust wood paneling.
5.    Wash vinyl and metal kick plates on doors.
6.    Wet mop all uncarpeted stairwells, landings, and handrails.
7.    Vacuum edges of all carpeted surfaces.

 

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MONTHLY    RESTROOMS
1.    Wash and sanitize metal partitions.
2.    Damp wipe lavatory tile walls (sanitize).
3.    Vacuum diffuser outlets in ceiling and walls.
4.    Remove cobwebs –dust high edges and corners
QUARTERLY    COMMON AREAS, OFFICES, CONFERENCE ROOMS, LOBBY, RECEPTION
1.    Clean and sanitize telephones.
2.    Clean entire interior glass in partitions and doors.
3.    Dust blinds.
4.    Dry-clean area adjacent to diffuser outlet.
5.    Clean metal of hi-hat light fixtures.
6.    High dust all horizontal and vertical surfaces not reached in night cleaning such as pipes, light fixtures, door frames, etc.
7.    Dust all picture frames, charts and similar hangings that are not dusted during regular nightly cleaning.
QUARTERLY    RESTROOMS AND SHOWERS
1.    Wash and sanitize exterior of lockers.
2.    Dry-clean adjacent to diffuser outlet.
3.    Power steam joints and floors.
4.    Power steam floor and joints in janitor closets.
QUARTERLY    CAFETERIA/KITCHENETTE
1.    Clean entire interior glass in partitions and doors.
2.    Power steam café floors and joints.
QUARTERLY    FLOORS – RESILENT. VINYL TILE AND/OR HARD
1.    Scrub, refinish and maintain.
2.    Machine scrub floors.
3.    Machine scrub bathroom floors.
4.    High dust lights, walls and grills.

SEMI

ANNUALLY

   COMMON AREAS, OFFICES, CONFERENCE ROOMS, LOBBY,
  

Wash all wastebaskets.

Strip and refinish all vinyl flooring, applying one (1) coat of sealer and three (3) coats of floor finish.

Shampoo all carpets

   RESTROOMS
1.    Hand dust, clean and wash all the tile walls as often as necessary, but not less than semi-annually.
2.    Wash restroom lighting fixtures.

 

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ANNUALLY   
1.    Wash all exterior light fixtures including reflectors, globes, diffusers, and trim.
2.    Wash all unpainted surfaces.
3.    Strip and refinish cafeteria vinyl flooring, applying one (1) coat of sealer and three (3) coats of floor finish.
4.    Shampoo carpets.
   DESCRIPTION OF SERVICES FOR CARPET MAINTENANCE PROGRAM
DAILY    Spot clean all affected areas.
  
GENERAL   
1.    Landlord shall provide in advance an annual schedule of dates, which indicates monthly, quarterly, and semi-annual service to be performed.
2.    Landlord will supply Plastic liners, C fold towels and toilet paper
3.    Provide supervisory personnel on site during all hours that services are provided and said supervisor shall perform the security check and complete the security check list form.
4.    Cleaning services not to begin prior to 6:00 PM.
5.    All persons providing services shall be required to have photo ID’s in plain sight at all times.
6.    All equipment and supplies shall be provided by Landlord.
7.    All equipment shall be maintained to provide satisfactory performance.
8.    All carts, etc., shall be equipped with wheels and bumpers to ensure no damage to floors and walls.
9.    Window washing of the exterior/interior building wall is excluded.
10.    Report any broken or damaged plumbing service.
11.    Cleaners will not stage or gather in common area lobbies.
12.    Keep all exterior doors locked when taking trash to exterior containers.
13.    Empty mop buckets nightly.
14.    Entrance doors must be kept locked.

 

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SCHEDULE 6.5

ESTOPPEL CERTIFICATE OF PARCEL B OWNER

 

To: Infinity Pharmaceuticals, Inc.

780 Memorial Drive

Cambridge, MA 02139

Attention:                     

 

  Re: Declaration of Easements, Covenants, Conditions and Restrictions, dated December 22, 1999, by 784 Memorial Drive LLC, filed with the Middlesex South Registry District of the Land Court as Document No. 1127474 and recorded in the Middlesex South Registry of Deeds on December 29, 1999, in Book 31008, Page 1, as amended by the First Amendment to Declaration of Easements, Covenants, Conditions and Restrictions, dated September 17, 2001, by 784 Memorial Drive LLC, ARE 770/784/790 Memorial Drive LLC and Landlord, filed with the Middlesex South Registry District of the Land Court as Document No. 1195705 and recorded in the Middlesex South Registry of Deeds in Book 34522, Page 324 (the “ Declaration ”)

Ladies and Gentlemen:

We understand that you have signed or are about to sign a lease with Parcel A Owner (as defined in the Declaration), by which Parcel A Owner would lease to you the entire building located on Parcel A (as defined in the Declaration), and that you are relying upon the following statements and agreements. Capitalized terms used but not defined herein shall have the meanings given thereto in the Declaration.

As Parcel A Owner’s request pursuant to Section 14.3 of the Declaration, the undersigned, as Parcel B Owner (as defined in the Declaration), certifies to you as follows as of the date set forth below:

 

  1. The Declaration is in full force and effect and unmodified, except as provided above in the definition of Declaration.

 

  2. To the knowledge of Parcel B Owner, Parcel B Owner is not in default in the performance or observance of its obligations under the Declaration.

 

  3. To the knowledge of Parcel B Owner, Parcel A Owner is not in default in the performance or observance of Parcel A Owner’s obligations under the Declaration.

 

  4. Since January 1, 2011, Parking Rent (as defined in Section 4.6.2 of the Declaration) has been invoiced directly to the existing tenant at Parcel A by Parking B Owner at the monthly rate of $21,705.00. No amounts are currently past due on account thereof. The Required Parking Spaces (as defined in Section 4.1 of the Declaration) are allocated to Parking A Owner as follows: (a) 29 spaces in the outside surface parking lot located at the Entire Property are allocated to Parking A Owner on a reserved basis and (b) 76 spaces in the above ground parking structure at the Entire Premises are allocated to Parking A Owner on a reserved basis.

 

  5. To the knowledge of Parcel B Owner, there are no shared Parcel A Utility Facilities or Parcel B Utility Facilities that are currently subject to reimbursement obligations among Parcel A and Parcel B pursuant to Sections 5.1 and 5.2 of the Declaration.

 

  6. The monthly estimated charges payable by Parcel A Owner to Parcel B Owner for Common Area Expenses (as defined in Section 9.2.4) under the Declaration for the calendar year 2013 is $3,220, subject to annual reconciliation as set forth in Section 9.2.4 of the Declaration. No amounts are currently past due on account thereof.


  7. This certificate shall be binding on Parcel B Owner, but nothing contained herein shall be deemed to amend or modify the provisions of the Declaration or the rights and obligations of the parties arising thereunder.

 Dated as of September     , 2014.

 

ARE-770/784/790 MEMORIAL DRIVE, 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:  

 

   

Name:

 
   

Title:

 

 

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SCHEDULE 13.15

Infinity Pharmaceuticals, Inc.

780 Memorial Drive

Cambridge, MA 02139

As of September     , 2014

ARE-770/784/790 Memorial Drive, LLC

c/o Alexandria Real Estate Equities, Inc.

385 E. Colorado Blvd, Suite 299

Pasadena, CA 91101

Re: Declaration of Easements, Covenants, Conditions and Restrictions recorded with the Middlesex South District Registry of Deeds in Book 31008, Page 1, and filed with the Middlesex South Registry District of the Land Court as Document No. 127474 (as amended from time to time, the “Declaration”).

Ladies and Gentlemen,

In connection with (i) an amendment dated as of the date hereof to our lease (the “780-790 Lease”) of the property owned by you and known as 780-790 Memorial Drive (which property is described on Exhibit A , and notice of which 780-790 Lease is recorded at Book 37003, Page 230 as Document Number 123563 and (ii) our contemporaneous lease dated as of the date hereof (as it may be amended, the “784 Lease”) of the property known as 784 Memorial Drive (more particularly described on Exhibit B ) (“784 Memorial”) from BHX, LLC, a Massachusetts limited liability company, as Trustee of 784 Realty Trust, we are writing to confirm certain agreements regarding the Declaration. By countersigning this letter agreement in the space appearing below, you confirm and agree, on behalf of yourself and your affiliate successors and affiliate assigns as Parcel B Owner under the Declaration, to the following (so long as Infinity Pharmaceuticals, Inc. or any of its affiliates is a tenant at 784 Memorial):

(A) The Parcel B Owner shall give us a copy of any notice of default given to the Parcel A Owner under the Declaration contemporaneously with the delivery of any such default notice to the Parcel A Owner, in the manner for which notices to Tenant are provided under the 780-790 Lease. In the event that we elect to cure any such default (having no obligation to do so), which cure shall be subject to the terms and conditions of the Declaration applicable to cures made by the Parcel A Owner generally, the Parcel B Owner shall recognize such cure as if made by the Parcel A Owner.

(B) Notwithstanding anything to the contrary in the Declaration, the Parcel B Owner under the Declaration shall accept instructions from us directly with respect to the parking rights held by us as a Parcel A Tenant, including without limitation the giving of Parking Change Notices, provided that a copy of any such instructions is given contemporaneously to Parcel A Owner. The Parcel A Owner acknowledges its consent to this subparagraph (D) by countersigning in the space located below.

Thank you for your assistance in this matter. This letter is executed as a sealed Massachusetts instrument.

 

Very truly yours,

 

INFINITY PHARMACEUTICALS, Inc.

 

By:  

 

  Name:
  Title:


Acknowledged and Agreed:

ARE-770/784/790 MEMORIAL DRIVE, LLC

By:

  Alexandria Real Estate Equities, L.P., managing member
  By:    

ARE-QRS Corp., general partner

    By:  

 

    Name:  
    Title:  

The undersigned Parcel A Owner joins in this Agreement solely for the

Purposes set forth in subparagraph (B), above.

BHX, LLC, as Trustee of 784 Realty Trust

 

By:

 

 

  Name:  

 

  Title:  

 

 

2

Exhibit 10.5

SEVENTH AMENDMENT TO LEASE

THIS SEVENTH AMENDMENT TO LEASE (this “ Seventh Amendment ”) is made as of November 6, 2014, by and between ARE-770/784/790 MEMORIAL DRIVE, LLC , a Delaware limited liability company (“ Landlord ”), and INFINITY PHARMACEUTICALS, INC. , a Delaware corporation (“ Tenant ”).

RECITALS

A. Landlord and Tenant are now parties to that certain Lease Agreement dated July 2, 2002, as amended by that certain First Amendment to Lease dated March 25, 2003, as further amended by that certain Second Amendment to Lease dated April 30, 2003, as further amended by that certain Third Amendment to Lease dated October 30, 2003, as further amended by that certain Fourth Amendment to Lease dated December 15, 2003, as further amended by that certain Fifth Amendment to Lease dated as of July 8, 2011 (“ Fifth Amendment ”), and as further amended by that certain Sixth Amendment to Lease dated as of June 1, 2012 (as amended, the “ Lease ”), pursuant to which Tenant leases certain space containing approximately 68,020 rentable square feet (“ Premises ”), consisting of (i) approximately 51,000 rentable square feet (“ 780 Premises ”) in that certain building located at 780 Memorial Drive, Cambridge, Massachusetts (formerly known as and referred to in the Lease as the “770 Premises” located at 770 Memorial Drive, Cambridge, Massachusetts, the “ 780 Building ”), and (ii) approximately 17,020 rentable square feet (“ 790 Premises ”) in that certain building located at 790 Memorial Drive, Cambridge, Massachusetts (the “ 790 Building ”). The Premises are more particularly described in the Lease. Capitalized terms used herein without definition shall have the meanings defined for such terms in the Lease.

B . The Base Term of the Lease is scheduled to expire on January 31, 2016.

C . Landlord and Tenant desire, subject to the terms and conditions set forth below, to amend the Lease to, among other things, (i) extend the Base Term of the Lease through March 31, 2025, and (ii) reflect the surrender of a portion of the 790 Premises consisting of approximately 13,159 rentable square feet on the third floor of the 790 Building, as shown on Exhibit A attached hereto (“ Surrender Premises ”) on January 31, 2016 (“ Surrender Date ”).

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. Extension of Base Term . Notwithstanding anything to the contrary contained in the Lease, the Base Term (except with respect to the Surrender Premises) is hereby extended through March 31, 2025.

 

2. Premises and Rentable Area of Premises . Commencing on February 1, 2016, the definitions of “ Premises ” and “ Rentable Area of Premises ” on Page 1 of the Lease are deleted in their entirety and replaced with the following:

Premises: That portion of the Project, containing, in the aggregate, approximately 54,861 rentable square feet, namely, (i) all three (3) floors of the 780 Building (defined below), consisting of approximately 51,000 rentable square feet (the “ 780 Premises ”), and (ii) a portion of the third floor of the 790 Building (defined below) consisting of approximately 3,008 rentable square feet and a portion of the first floor of the 790 Building consisting of approximately 853 rentable square feet (collectively, the “ 790 Premises ”), all as determined by Landlord, as shown on Exhibit A . The 780 Premises and the 790 Premises are sometimes referred to collectively herein as the “ Premises ”.”

 

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1


“Rentable Area of Premises:    780 Premises:    51,000 sq. ft.
   790 Premises:    3,861 sq. ft.
   Total:    54,861 sq. ft.”

Commencing on February 1, 2016, Exhibit A attached to the Lease is modified to exclude the Surrender Premises.

Landlord and Tenant acknowledge and agree that, as of the date of this Seventh Amendment, all references in the Lease to the “770 Premises” shall be deemed to mean the “780 Premises” and all references in the Lease to “770 Memorial Drive, Cambridge, Massachusetts” shall mean “780 Memorial Drive, Cambridge, Massachusetts.”

 

3. Base Rent . Tenant shall continue paying Base Rent as provided in the Lease through January 31, 2016. Commencing (i) on February 1, 2016, through January 31, 2018, Tenant shall pay Base Rent in the amount of $69.00 per rentable square foot of the Premises per annum, and (ii) on February 1, 2018, through March 31, 2025, Tenant shall pay Base Rent in the amount of $70.00 per rentable square foot of the Premises per annum.

Notwithstanding anything to the contrary contained in the Lease or in this Seventh Amendment, so long as Tenant is not in Default under the Lease, or been in Default under the Lease 3 or more times in the 12-month periods immediately preceding the time periods set forth below, Tenant shall not be required to pay any Base Rent for (i) 54,861 rentable square feet of the Premises for the period commencing on February 1, 2015, through July 31, 2015 (for the avoidance of doubt, Tenant shall continue to pay Base Rent during such period for the balance of the Premises consisting of 13,159 rentable square feet), (ii) February 1, 2016, through February 29, 2016, (iii) February 1, 2017, through February 28, 2017, and (iv) February 1, 2018, through February 28, 2018.

 

4. Tenant’s Share .

a . Commencing on February 1, 2016, the defined term “ Tenant’s Share of Operating Expenses ” on page 1 of the Lease is deleted in its entirety and replaced with the following:

Tenant’s Share: 100% as to 780 Building, 7.98% as to the 790 Building”

b. As of the date of this Seventh Amendment, the following is hereby added as an exclusion to Operating Expenses under Section 5 of the Lease: “The cost of insurance covering debt service or similar financing charges.”

c. Notwithstanding anything to the contrary contained in the Lease, as of the date of this Seventh Amendment, any and all references in the penultimate paragraph of Section 5 of the Lease to “60 days” shall be deleted and replaced with “120 days.”

d . Landlord agrees that, notwithstanding anything to the contrary contained in the Lease, Landlord shall deliver an Annual Statement to Tenant each year no later than 180 days after the end of the calendar year. Also, Landlord agrees to deliver to Tenant prior to the end of the third quarter of each calendar year during the Term a preliminary Annual Estimate for the following calendar year. Tenant specifically acknowledges and agrees that the amounts set forth in each preliminary Annual Estimate will be merely an estimate by Landlord and Landlord shall have no liability to Tenant in connection with such estimate and Tenant waives any and all claims which Tenant may have against Landlord in connection with such estimate including, without limitation, such estimate not being correct.

 

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5. Base Building Allowance . Landlord shall make available to Tenant a tenant improvement allowance equal to $20.00 per rentable square foot of the Premises, or $1,097,220 in the aggregate (the “ Base Building Allowance ”) for the design and construction of capital improvements to the 780 Premises acceptable to Landlord and Tenant that are reasonably intended to result in a reduction in Operating Expenses and/or extend the life of existing Building Systems, as reasonably determined by Landlord and Tenant (‘ Base Building Alterations ”). Landlord and Tenant agree that the preliminary scope of work for the Base Building Alterations attached hereto as Exhibit B has been approved by Landlord and Tenant. The Base Building Alterations shall be designed and constructed in accordance with this Section 5 and Section 12 of the Lease; provided, however, that notwithstanding anything to the contrary contained in Section 12 of the Lease, Landlord shall not unreasonably withhold, condition or delay its consent to Base Building Alterations desired by Tenant notwithstanding the fact that the Base Building Alterations will affect the structure of the 780 Building. The Base Building Allowance shall only be available for the design and construction of the Base Building Alterations. Except for the Base Building Allowance, Tenant shall be solely liable for all of the costs of the Base Building Alterations. If any rebate or credit is actually paid by any Governmental Authorities, any Utility provider or any other third party in connection with any Base Building Alterations actually constructed by Tenant, such rebate or credit shall be applied as follows: (i) to reimburse Tenant for any and all amounts, if any, paid by Tenant for such Base Building Alterations in excess of the Base Building Allowance, and (ii) the remaining balance of any such rebate or credits shall remain available for future Base Building Alterations. If any portion of the Base Building Allowance has not been requisitioned by Tenant on or before January 31, 2021, Tenant may elect, by delivery of written notice to Landlord, to apply up to 10% of the unused Base Building Allowance to Operating Expenses due and payable under the Lease by Tenant. Except as provided in the immediately preceding sentence, Tenant shall have no right or benefit (including any reduction in Base Rent) to any remaining balance of the Base Building Allowance not applied to the cost of Base Building Alterations prior to the expiration of the Base Term or to any rebate or credits remaining for use pursuant to sub-section (ii) above not used prior to the expiration of the Base Term to pay the cost of additional Base Building Alterations desired by Tenant. Notwithstanding anything to the contrary contained herein, Landlord has no obligation to pay any costs of the Base Building Alterations in excess of the Base Building Allowance. Tenant acknowledges that all Base Building Alterations shall become the property of Landlord upon installation and may not be removed by Tenant, nor shall Tenant have the right to remove such Base Building Alterations at any time during the Term.

With respect to any portion of the Base Building Allowance not used before January 31, 2016, commencing in the calendar year 2016, prior to July 30 th of each year, Tenant shall deliver to Landlord for Landlord’s approval, in Landlord’s reasonable discretion, a preliminary scope of work and budget for the Base Building Alterations (which preliminary scope of work and budget shall be merely an estimate and shall not be binding on Tenant) for the Base Building Alterations desired by Tenant to be constructed during the 12-month period following Tenant’s delivery of such preliminary scope of work and budget to Landlord. The Base Building Alterations reflected in each applicable preliminary scope of work and budget shall be designed and constructed by Tenant pursuant to the terms of Section 12 of the Lease and this Section 5 .

The Base Building Alterations may be constructed in phases. During the course of design and construction of any phase of Base Building Alterations, Landlord shall reimburse Tenant or pay directly to Tenant contractors on a pro rata basis a percentage of the costs of the applicable phase of the Base Building Alterations (equal to the percentage that the remaining Base Building Allowance bears to the total budget for such Base Building Alterations) once a month against a draw request in Landlord’s standard form, containing evidence of payment of the applicable costs and such certifications, lien waivers (including a conditional lien release (which shall be in the statutory form, where applicable) for each progress payment and unconditional lien releases (where permitted pursuant to Legal Requirements) for the prior month’s progress payments), inspection reports and other matters as Landlord customarily obtains, to the extent of Landlord’s approval thereof for payment (collectively, the “ Reimbursement Deliveries ”), no later than 30 days following receipt of such draw request. Upon completion of the applicable phase of Base Building Alterations (and prior to any final disbursement of the Base Building Allowance in

 

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connection with such phase of Base Building Alterations) Tenant shall deliver to Landlord the following items: (i) sworn statements setting forth the names of all contractors and subcontractors who did work on such phase of the Base Building Alterations and final lien waivers from all such contractors and subcontractors; and (ii) “as built” plans or marked-up construction drawings for the Base Building Alterations constructed during such phase. If Landlord does not reimburse the cost of Base Building Alterations (up the full amount of the Base Building Allowance) to Tenant within (x) if Landlord does not dispute such costs, the date that is 90 days after Tenant’s delivery to Landlord of all required Reimbursement Deliveries, or (y) if Landlord disputes such costs, the date that is 90 days after the earlier to occur of (1) the date the parties mutually agree on such costs and Landlord’s responsibility therefor, and (2) the date a final judgment is issued by a court of law or an out of court settlement is reached by the parties with respect to such costs, then, in each case, Tenant may deduct from Base Rent next payable by Tenant under the Lease the amount of such costs.

The general contractor for the Base Building Alterations shall be TRG Builders, The Richmond Group or another general contractor selected by Tenant, subject to Landlord’s reasonable approval. Prior to the commencement of each phase of the Base Building Alterations, Tenant shall deliver to Landlord a copy of any contract with Tenant’s contractors (including the architect), and certificates of insurance from any contractor performing any part of such phase of the Base Building Alterations evidencing industry standard commercial general liability, automotive liability, “builder’s risk”, and workers’ compensation insurance. Tenant shall cause the general contractor to provide a certificate of insurance naming Landlord, Alexandria Real Estate Equities, Inc., and Landlord’s lender (if any) as additional insureds for the general contractor’s liability coverages required above.

Tenant shall pay to Landlord administrative rent equal to 1% of the costs incurred by Tenant in connection with any Base Building Alteration for monitoring and inspecting the construction of the Base Building Alterations, which sum shall be payable from the Base Building Allowance. Landlord shall not be entitled to collect any additional fee from Tenant in connection with the monitoring and inspecting the construction of the Base Building Improvements.

Notwithstanding anything to the contrary contained in this Seventh Amendment or in the Lease, Tenant may not perform any Base Building Alterations in the 790 Building.

Immediately following the substantial completion by Tenant of any Base Building Alterations, Tenant shall, at Tenant’s cost, take all necessary steps required to assign to Landlord all available warranties/guaranties with respect to such Base Building Alterations. Immediately upon such assignment of such warranties/guaranties to Landlord, such Base Building Alterations shall immediately be deemed either a structural portion of the Project or a Building System under the Lease and Landlord shall be responsible in accordance with the terms of Section 13 of the Lease to maintain such Base Building Alterations.

 

6. Security Deposit . Effective as of the date of this Seventh Amendment, the definition of “ Security Deposit ” on the first page of the Lease is deleted in its entirety and replaced with the following:

Security Deposit : $630,901.50”

Landlord currently holds a Security Deposit of $1,109,575.71 under the Lease. Concurrent with Tenant’s delivery of a signed original of this Seventh Amendment to Landlord, Tenant shall deliver to Landlord an amendment to the existing Letter of Credit being held by Landlord reducing the amount of such Letter of Credit to $630,901.50.

 

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7. Additional TI Allowance . Commencing on the date of this Seventh Amendment, Landlord shall make available to Tenant a tenant improvement allowance equal to $35.00 per rentable square foot of the Premises, or $1,920,135 in the aggregate (“ Additional Allowance ”), for the design and construction after the date of this Seventh Amendment of Alterations to the Premises (which Alterations shall be designed and constructed pursuant to and in accordance with this Section 7 and Section 12 of the Lease) (“ Seventh Amendment Alterations ”). Except as otherwise provided in this Section 7 , the Additional Allowance shall only be available for the hard and soft costs of construction of such Seventh Amendment Alterations; provided that a portion of the Additional Allowance, up to $2.00 per rentable square foot of the Premises may be used toward the cost of Tenant’s teledata/computer cabling for the Premises. Tenant acknowledges that upon the expiration of the Term of the Lease, all Seventh Amendment Alterations shall become the property of Landlord and may not be removed by Tenant, nor shall Tenant have the right to remove such Seventh Amendment Alterations at any time during the Term. Except for the Additional Allowance, Tenant shall be solely liable for all of the costs of any and all Seventh Amendment Alterations.

The Seventh Amendment Alterations may be constructed in phases. During the course of design and construction of any phase of Seventh Amendment Alterations, Landlord shall reimburse Tenant or pay directly to Tenant’s contractors on a pro rata basis a percentage of the costs of the applicable phase of the Seventh Amendment Alterations (equal to the percentage that the remaining Additional Allowance bears to the total budget for such Seventh Amendment Alterations) once a month against a draw request in Landlord’s standard form and all applicable Reimbursement Deliveries, no later than 30 days following receipt of such draw request. Upon completion of the applicable phase of Seventh Amendment Alterations (and prior to any final disbursement of the Additional Allowance in connection with such phase of Seventh Amendment Alterations) Tenant shall deliver to Landlord the following items: (i) sworn statements setting forth the names of all contractors and subcontractors who did work on such phase of the Seventh Amendment Alterations and final lien waivers from all such contractors and subcontractors; and (ii) “as built” plans or marked-up construction drawings for the Seventh Amendment Alterations constructed during such phase. Landlord shall be entitled to receive the benefit of all construction warranties and manufacturer’s equipment warranties relating to equipment installed in the Premises as part of the Seventh Amendment Alterations. If Landlord does not reimburse the cost of Seventh Amendment Alterations (up the full amount of the Additional Allowance) to Tenant within (x) if Landlord does not dispute such costs, the date that is 90 days after Tenant’s delivery to Landlord of all required Reimbursement Deliveries, or (y) if Landlord disputes such costs, the date that is 90 days after the earlier to occur of (1) the date the parties mutually agree on such costs and Landlord’s responsibility therefor, and (2) the date a final judgment is issued by a court of law or an out of court settlement is reached by the parties with respect to such costs, then, in each case, Tenant may deduct from Base Rent next payable by Tenant under the Lease the amount of such costs.

The contractor for the Seventh Amendment Alterations shall be selected by Tenant, subject to Landlord’s approval. Prior to the commencement of each phase of the Seventh Amendment Alterations, Tenant shall deliver to Landlord a copy of any contract with Tenant’s contractors (including the architect), and certificates of insurance from any contractor performing any part of such phase of the Seventh Amendment Alterations evidencing industry standard commercial general liability, automotive liability, “builder’s risk”, and workers’ compensation insurance. Tenant shall cause the general contractor to provide a certificate of insurance naming Landlord, Alexandria Real Estate Equities, Inc., and Landlord’s lender (if any) as additional insureds for the general contractor’s liability coverages required above.

With respect to any portion of the Additional Allowance not used before January 31, 2016, commencing in the calendar year 2016, prior to July 30 th of each year, Tenant shall deliver to Landlord for Landlord’s approval, in Landlord’s reasonable discretion, a preliminary scope of work and budget (which preliminary scope of work and budget shall be merely an estimate and shall not be binding on Tenant) for the Seventh Amendment Alterations desired by Tenant to be constructed during the 12-month period following Tenant’s delivery of such preliminary scope of

 

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work and budget to Landlord. The Seventh Amendment Alterations reflected in each applicable preliminary scope of work and budget shall be designed and constructed by Tenant pursuant to the terms of Section 12 of the Lease and this Section 7 . Notwithstanding anything to the contrary contained herein, Tenant may, upon written notice to Landlord, elect to use all or a portion of the Additional Allowance to cover costs of the Base Building Alterations for which Tenant is responsible, if any. The Additional Allowance shall only be available for use by Tenant for the design and construction of Seventh Amendment Alterations (or, if elected by Tenant pursuant to the immediately preceding sentence, the cost of Base Building Alterations for which Tenant is responsible). Tenant shall have no right to the use or benefit of any portion of the Additional Allowance not requisitioned by Tenant in accordance with this Section 7 prior to the expiration of the Term.

 

8. Surrender of the Surrender Premises . The Lease with respect to the Surrender Premises shall terminate as provided for in the Lease on the Surrender Date. Tenant shall voluntarily surrender the Surrender Premises on or before such date in the condition which Tenant is required to surrender the Premises as of the expiration of the Lease and in compliance with the surrender requirements set forth in the Lease. From and after the Surrender Date, Tenant shall have no further rights or obligations of any kind with respect to the Surrender Premises. Notwithstanding the foregoing, those provisions (i) of Section 5 of the Lease providing for the reconciliation of Operating Expenses, and (ii) which, by their terms, survive the termination of the Lease, shall survive the surrender of the Surrender Premises and termination of the Lease with respect to the Surrender Premises as provided for herein. Nothing herein shall excuse Tenant from its obligations under the Lease with respect to the Surrender Premises prior to the Surrender Date.

 

9 . Right to Extend . As of the date of this Seventh Amendment, Section 41 of the Lease is hereby deleted in its entirety and replaced with the following and Tenant shall have no other right to extend the Term of the Lease except as set forth in this Section 41 :

“41. Right to Extend Term . Tenant shall have the right to extend the Term of the Lease upon the following terms and conditions:

(a) Extension Rights . Tenant shall have two (2) rights (each, an “ Extension Right ”) to extend the term of the Lease for five (5) years each (each, an “ Extension Term ”) on the same terms and conditions as the Lease (other than with respect to Base Rent or any Work Letter).

Upon the commencement of any Extension Term, Base Rent shall be payable at 95% of the Market Rate (as defined below). Base Rent shall thereafter be adjusted on each annual anniversary of the commencement of such Extension Term by a percentage as determined at the time the Market Rate is determined. As used herein, “ Market Rate ” shall mean the then market rental rate as determined in accordance with this Section 41 for combined laboratory and office space in Cambridge, Massachusetts comparable to the Premises in age, quality (including all Landlord’s Work, Tenant Improvements, Alterations (including, without limitation, the Base Building Alterations and the Seventh Amendment Alterations) and other improvements), level of finish, and proximity to amenities and public transit, taking into account all such other factors as are typically considered in arms length negotiations of rental rates for combined laboratory and office space comparable to the Premises in Cambridge, Massachusetts. In addition, Landlord may impose a reasonably determined market rent for the parking rights provided hereunder.

Tenant shall exercise each Extension Right, if at all, as follows: (i) Tenant shall deliver written notice to Landlord (the “ Interest Notice ”) not more than sixteen (16) months nor less than thirteen (13) months prior to the expiration of the Base Term of this Lease or, if applicable, the expiration of the prior Extension Term, stating that Tenant may be interested in exercising such Extension Right; (ii) if Tenant delivers an Interest Notice to Landlord, Landlord shall deliver written notice (the “ Extension Rent Notice ”) to Tenant not later than the date that is twelve (12) months prior to the expiration of the Base Term of this Lease or, if applicable, the expiration of the prior

 

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Extension Term, setting forth Landlord’s determination of the Market Rent; (iii) if Tenant, within 30 days after Landlord’s delivery to Tenant of an Extension Rent Notice does not agree with Landlord’s determination of Market Rent and escalations, Tenant shall deliver to Landlord a notice objecting to Landlord’s determination (“ Objection Notice ”), which Objection Notice shall include Tenant’s proposal for the Market Rate and escalations, (iv) promptly following Landlord’s receipt of the Objection Notice, the parties shall submit the determination of the Market Rate and escalations to arbitration in accordance with Section 41(b) below, and (v) following the determination of the Market Rate and escalations pursuant to the arbitration, if Tenant wishes to exercise such Extension Right, Tenant shall, on or before the date (the “ Exercise Date ”) which is ten (10) months prior to the expiration of the Base Term of this Lease or, if applicable, the expiration of the prior Extension Term, exercise such Extension Right by delivering written notice (“ Extension Notice ”) thereof to Landlord. Tenant acknowledges and agrees that, if Tenant has delivered an Extension Notice to Landlord pursuant to this paragraph, Tenant shall have no right thereafter to rescind such Extension Notice or elect not to extend the term of the Lease for the Extension Term subject to the Extension Notice.

(b) Arbitration .

(i) Within 10 days after Tenant’s delivery to Landlord of an Objection Notice, Landlord and Tenant shall each, by written notice delivered to the other, select an Arbitrator. If either party fails to timely give notice of its selection for an Arbitrator, the other party’s submitted proposal shall determine the Base Rent for the Extension Term. The 2 Arbitrators so appointed shall, within 5 business days after their appointment, appoint a third Arbitrator. If the 2 Arbitrators so selected cannot agree on the selection of the third Arbitrator within the time above specified, then either party, on behalf of both parties, may request such appointment of such third Arbitrator by application to any state court of general jurisdiction in the jurisdiction in which the Premises are located, upon 10 days prior written notice to the other party of such intent.

(ii) The decision of the Arbitrator(s) shall be made within 20 days after the appointment of a single Arbitrator or the third Arbitrator, as applicable. The decision of the single Arbitrator shall be final and binding upon the parties. The average of the two closest Arbitrators in a three Arbitrator panel shall be final and binding upon the parties. Each party shall pay the fees and expenses of the Arbitrator appointed by or on behalf of such party and the fees and expenses of the third Arbitrator shall be borne equally by both parties. After the determination of the Market Rate and escalations, the parties shall make any necessary adjustments to such payments made by Tenant. Landlord and Tenant shall then execute an amendment recognizing the Market Rate and escalations for the Extension Term.

(iii) An “ Arbitrator ” shall be any person appointed by or on behalf of either party or appointed pursuant to the provisions hereof and: (i) shall be (A) a member of the American Institute of Real Estate Appraisers with not less than 10 years of experience in the appraisal of improved office and laboratory real estate in the greater Boston metropolitan area, or (B) a licensed commercial real estate broker with not less than 15 years experience representing landlords and/or tenants in the leasing of office and laboratory space in the greater Boston metropolitan area, (ii) devoting substantially all of their time to professional appraisal or brokerage work, as applicable, at the time of appointment and (iii) be in all respects impartial and disinterested.

(c) Rights Personal . The Extension Rights are personal to Tenant and are only assignable by Tenant pursuant to a Permitted Assignment. All other assignments of the Extension Rights shall be subject to Landlord’s prior written consent, which may be granted or withheld in Landlord’s sole discretion separate and apart from any consent by Landlord to an assignment of Tenant’s interest in the Lease. In addition to the foregoing, at Landlord’s option, Tenant shall not have the right to exercise an Extension Right if subleases (other than Permitted Assignments) affecting more than 50% of the 780 Premises are in effect at the time of such exercise and at the commencement of such Extension Term.

 

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(d) Exceptions . Notwithstanding anything set forth above to the contrary, the Extension Rights shall, at Landlord’s option, not be in effect and Tenant may not exercise any of the Extension Rights:

(i) during any period of time that Tenant is in Default under any provision of this Lease; or

(ii) if Tenant has been in Default under any provision of this Lease 3 or more times with respect to the payment of Rent, whether or not the Defaults are cured, during the 12 month period immediately prior to the date that Tenant intends to exercise an Extension Right, whether or not the Defaults are cured.

(e) No Extensions . The period of time within which an Extension Right may be exercised shall not be extended or enlarged by reason of Tenant’s inability to exercise such Extension Right.

(f) Termination . The Extension Rights shall, at Landlord’s option, terminate and be of no further force or effect even after Tenant’s due and timely exercise of an Extension Right, if, after such exercise, but prior to the commencement date of such Extension Term, (i) Tenant fails to timely cure any Default by Tenant then existing under this Lease for which Tenant received the applicable notice; or (ii) Tenant has Defaulted 3 or more times with respect to the payment of Rent during the period from the date of the exercise of an Extension Right to the date of the commencement of the applicable Extension Term, whether or not such Defaults are cured.”

 

10. Parking . Effective as of the date of this Seventh Amendment, the first paragraph of Section 10 of the Lease is hereby deleted in its entirety and replaced with the following:

“10. Parking, Transportation . Subject to all matters of record, Force Majeure, a Taking (as defined in Section 19 below) and the exercise by Landlord of its rights hereunder, Tenant shall have the right to park in (a) 47 reserved spaces in the parking garage located in the Project in the locations shown on Exhibit E and 19 non-reserved spaces on the surface parking lot in the Project, in each case subject to Landlord’s reasonable, non-discriminatory parking rules and regulations consistent with this Section 10 and payment of $230 per month during the Term for each garage parking space and $170 per month for each surface parking space and (b), in addition, until the Surrender Date, 11 reserved spaces in the parking garage located in the Project in the locations shown on Exhibit E and 3 non-reserved spaces on the surface parking lot in the Project, subject to payment at the rate of $273.64 per month during the Term for each garage parking space and $179.17 per month for each surface parking space (collectively, the charges in clauses (a) and (b) are referred to as the “ Parking Charges ”). Commencing on December 1, 2015, and continuing thereafter on each December 1 st of each year during the term of this Lease thereafter (each, a “ Parking Charge Adjustment Date ”), the Parking Charges provided for in clause (a) of the preceding sentence shall be increased by multiplying the Parking Charges payable immediately before such Parking Charge Adjustment Date by 3% and the Parking Charges provided for in clause (b) of the preceding sentence shall be adjusted to market rate, each such increase not to exceed 5% of the amount paid for the immediately preceding year (each such percentage, a “ Parking Charge Adjustment Percentage ”) and adding the resulting amount to the applicable Parking Charges payable immediately before such Parking Charge Adjustment Date. The Parking Charges, as so adjusted, shall thereafter be due as provided herein. Landlord shall give Tenant written notice indicating the Parking Charges, as adjusted pursuant to this Section 10 , and Tenant shall pay to Landlord an amount equal to any underpayment of Parking Charges by Tenant within 30 days of Landlord’s notice to Tenant. Failure to deliver such notice shall not reduce, abate, waive or diminish Tenant’s obligation to pay the adjusted Parking Charges. Landlord shall impose and uniformly enforce parking rules and regulations upon all users of the parking garage and the surface parking lot in the Project.

 

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Tenant acknowledges that the requirements related to parking and transportation demand management set forth in Exhibit F attached to the Lease, with respect to which Tenant is required to comply, are required pursuant to that certain Parking and Transportation Demand Management Plan, as may be amended (“ PTDM ”), a copy of which is attached to this Seventh Amendment as Exhibit F . Tenant acknowledges that Operating Expenses shall include expenses and assessments related to the PTDM (except to the extent the cost thereof is excluded from Operating Expenses pursuant to Section 5 of the Lease).”

 

11 . Utilities . Notwithstanding anything to the contrary contained in the Lease, if (i) a stoppage of an Essential Service (as defined below) to the Premises shall occur and such stoppage is due solely to the gross negligence or willful misconduct of Landlord and not due in any part to any act or omission on the part of Tenant or any Tenant Party or any matter beyond Landlord’s reasonable control (any such stoppage of an Essential Service being hereinafter referred to as a “ Service Interruption ”), and (ii) such Service Interruption continues for more than 3 consecutive business days after Landlord shall have received written notice thereof from Tenant, and (iii) as a result of such Service Interruption, the conduct of Tenant’s normal operations in the Premises are materially and adversely affected, then there shall be an abatement of one day’s Base Rent for each day during which such Service Interruption continues after such 3 consecutive business day period; provided, however, that if any part of the Premises is reasonably useable for Tenant’s normal business operations or if Tenant conducts all or any part of its operations in any portion of the Premises notwithstanding such Service Interruption, then the amount of each daily abatement of Base Rent shall only be proportionate to the nature and extent of the interruption of Tenant’s normal operations or ability to use the Premises. The rights granted to Tenant under this paragraph shall be Tenant’s sole and exclusive remedy resulting from a failure of Landlord to provide services, and Landlord shall not otherwise be liable for any loss or damage suffered or sustained by Tenant resulting from any failure or cessation of services. For purposes hereof, the term “ Essential Services ” shall mean the following services: access to the Premises, HVAC service, water, sewer and electricity, but in each case only to the extent that Landlord has an obligation to provide same to Tenant under this Lease. The provisions of this paragraph shall not apply to any sublessee of Tenant. To the extent that the Service Interruption is the result of a casualty or a Taking, such Service Interruption shall be governed by the terms of Section 18 or Section 19 of the Lease, as applicable, and the terms of this Section 11 shall not apply.

Notwithstanding anything to the contrary contained in this Section 11 , Tenant shall also have the self-help right provided for in Section 15 of this Seventh Amendment.

Upon written notice to Landlord, Tenant may elect, at any time during the Term, to retain a third party reasonably acceptable to Landlord to provide janitorial services to the Premises, in which case Tenant shall pay such third party directly for such janitorial services and janitorial services to the Premises only shall be excluded from Operating Expenses. Unless Tenant delivers Landlord written notice that it has elected to retain a third party to provide janitorial services to the Premises pursuant to the immediately preceding sentence, Landlord shall provide janitorial services to the Premises in a manner consistent with comparable first class laboratory/office buildings within the vicinity of the Building and Landlord shall charge Tenant directly for the actual cost of such janitorial services.

 

12 . Alterations . Notwithstanding anything to the contrary contained in the Lease, Tenant shall not be required to furnish any security or make other arrangements to assure the payment of Alterations; provided, however, that Tenant shall continue to be required to complete all such Alterations free and clear of liens.

 

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Notwithstanding anything to the contrary contained in the Lease, Tenant shall not be required to remove any Alterations or improvements existing in the Premises as of the date of this Seventh Amendment, any future office Alterations or improvements to the Premises, or any laboratory Alterations and improvements to the Premises that will be useable by future laboratory tenants of the Premises, as reasonably determined by Landlord, at the expiration or earlier termination of the Term nor shall Tenant have the right to remove such Alterations at any time (except as may otherwise be permitted under the Lease). Landlord shall, if requested by Tenant in writing at the time Landlord’s approval of any such Alteration or improvements is requested notify Tenant whether Landlord requires that Tenant remove such Alteration or improvement upon the expiration or earlier termination of the Term.

Tenant hereby discloses to Landlord that Tenant plans to install and/or construct in the Premises (although Tenant shall have no obligation to install or construct in the Premises) certain improvements including, without limitation the following items: security systems, kitchen and cafeteria facilities consistent with a first class office use, data cabling, lobby modifications in the 780 Building, restrooms, a fitness facility, and utilities consistent with first class office and laboratory use (collectively, “ Planned Improvements ”). Landlord and Tenant acknowledge and agree that the Planned Improvements shall be designed and constructed as Seventh Amendment Alterations in accordance with Section 12 of the Lease and Section 7 of this Seventh Amendment. Landlord agrees to reasonably cooperate with Tenant, at no cost to Landlord, in connection with Tenant’s efforts to obtain utility easements reasonably required in connection with Tenant’s installation of utilities as part of the Planned Improvements. Tenant shall not be required to remove any Planned Improvements actually installed or constructed by Tenant at the expiration or earlier termination of the Term nor shall Tenant have any right to remove any of the Planned Improvements actually installed or constructed by Tenant.

Exhibit G to the Lease is hereby amended to include the items set forth on Exhibit D attached to this Seventh Amendment.

 

13. Assignment .

a. The second sentence of Section 22(a) of the Lease is hereby deleted in its entirety.

b. Section 22(b) of the Lease is hereby deleted in its entirety and replaced with the following:

“(b) Recapture . If Landlord exercises an Assignment Termination (as defined in Section 22(c) below) in connection with any proposed assignment, hypothecation or other transfer or subletting concerns more than (together with all other then effective subleases) 50% of the Premises pursuant to Section 22(b) below and Tenant does not withdraw the applicable Assignment Notice (as defined in Section 22(c) below), which results in the termination of the Lease with respect to the portion of the Premises reflected in such Assignment Notice, the Rentable Area of the Premises, Base Rent, Tenant Share of Operating Expenses, Tenant’s Parking Spaces and any other amounts calculated based on the Rentable Area of he Premises shall be proportionately revised to reflect such deletion in an instrument to be executed by Landlord and Tenant confirming the same.”

c. Section 22(c) of the Lease is hereby deleted in its entirety and replaced with the following:

“(c) Permitted Transfers . If Tenant desires to assign, sublease, hypothecate or otherwise transfer this Lease or sublet the Premises other than pursuant to a Permitted Assignment (as defined below), then at least 15 business days, but not more than 180 business days, before the date Tenant desires the assignment or sublease to be effective (the “ Assignment Date ”), Tenant shall give Landlord a notice (the “ Assignment Notice ”) containing

 

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such information then in Tenant’s possession or control about the proposed assignee or sublessee, including the proposed use of the Premises and any Hazardous Materials proposed to be used, stored handled, treated, generated in or released or disposed of from the Premises, the Assignment Date, any relationship between Tenant and the proposed assignee or sublessee, and all material terms and conditions of the proposed assignment or sublease, including a copy of any proposed assignment or sublease, to be followed by such assignment or sublease document in its final form when available (provided that Landlord shall further have the right to review and approve or disapprove the proposed form of sublease before the effective date of such subletting) and such other information as Landlord may deem reasonably necessary or appropriate to its consideration whether to grant its consent. Landlord may, by giving written notice to Tenant within 15 business days after receipt of the Assignment Notice: (i) grant such consent, (ii) refuse such consent (provided that any consent by Landlord shall not be unreasonably withheld, conditioned or delayed); or (iii) if the proposed assignment, hypothecation or other transfer or subletting concerns more than (together with all other then-effective subleases) 50% of the Premises for all or substantially all of the remaining Term, terminate this Lease with respect to the space described in the Assignment Notice as of the Assignment Date (an “ Assignment Termination ”), subject to Tenant’s right to withdraw the subject Assignment Notice as provided below. Among other reasons, it shall be reasonable for Landlord to withhold its consent in any of these instances: (1) the proposed assignee or subtenant is a governmental agency, unless such governmental agency is then leasing other space in the Project from Landlord; (2) in Landlord’s reasonable judgment, the use of the Premises by the proposed assignee or subtenant would entail any alterations that would materially lessen the value of the leasehold improvements in the Premises, or would require materially increased services by Landlord; (3) in Landlord’s reasonable judgment, the proposed assignee or subtenant is engaged in areas of scientific research or other business concerns that are controversial such that they may (i) attract or cause negative publicity for or about the Building or the Project, (ii) negatively affect the reputation of the Building, the Project or Landlord, (iii) attract protestors to the Building or the Project, or (iv) lessen the attractiveness of the Building or the Project to any tenants or prospective tenants, purchasers or lenders; (4) in Landlord’s reasonable judgment, the proposed assignee or subtenant lacks the creditworthiness to support the financial obligations it will incur under the proposed assignment or sublease; (5) in Landlord’s reasonable judgment, the character, reputation, or business of the proposed assignee or subtenant is inconsistent with the desired tenant-mix or the quality of other tenancies in the Project or is inconsistent with the type and quality of the nature of the Building; (6) Landlord has received from any prior landlord to the proposed assignee or subtenant a negative report concerning such prior landlord’s experience with the proposed assignee or subtenant; (7) Landlord has experienced previous defaults by or is in litigation with the proposed assignee or subtenant; and (8) the use of the Premises by the proposed assignee or subtenant will violate any applicable Legal Requirement in violation of this Lease. If Landlord delivers notice of its election to exercise an Assignment Termination, Tenant shall have the right to withdraw such Assignment Notice by written notice to Landlord of such election within ten (10) business days after Landlord’s notice electing to exercise the Assignment Termination. If Tenant withdraws such Assignment Notice, this Lease shall continue in full force and effect. If Tenant does not withdraw such Assignment Notice, this Lease, and the term and estate herein granted, shall terminate as of the Assignment Date with respect to the space described in such Assignment Notice. No failure of Landlord to exercise any such option to terminate this Lease, or to deliver a timely notice in response to the Assignment Notice, shall be deemed to be Landlord’s consent to the proposed assignment, sublease or other transfer. Tenant shall pay to Landlord for all of Landlord’s reasonable out-of-pocket expenses in connection with its consideration of any Assignment Notice, in an amount not to exceed $2,250 per request.

Notwithstanding the foregoing, Landlord’s consent to an assignment of this Lease or a subletting of any portion of the Premises to any entity controlling, controlled by or under common control with Tenant (a “ Control Permitted Assignment ”) shall not be required. For the purposes of this Lease, an entity shall be deemed to “control” another entity if it owns fifty-one percent (51%) or more of the outstanding voting stock of such entity, if such entity is a corporation or other majority

 

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equity and control interest, if such entity is not a corporation, and possesses the power to direct or cause the direction of the management and policy of such corporation or other entity, whether through the ownership of voting securities, by statute or according to the provisions of a contract. In addition, Tenant shall have the right to assign this Lease, upon 30 days prior written notice to Landlord (unless Tenant is prohibited from providing such notice by confidentiality or Legal Requirements in which case Tenant shall notify Landlord promptly thereafter) but without obtaining Landlord’s prior written consent, to a corporation or other entity which is a successor-in-interest to Tenant, by way of merger, consolidation or corporate reorganization, or by the purchase of all or substantially all of the assets or the ownership interests of Tenant provided that all of the following apply: (i) such merger or consolidation, or such acquisition or assumption, as the case may be, is for a bona fide business purpose and not principally for the purpose of transferring the Lease, (ii) immediately following the transaction, the valuation or equity market capitalization (as independently determined in accordance with generally accepted accounting principles (“ GAAP ”) or by a professional third party investor) of the assignee (or Tenant if Tenant is the surviving entity of the transaction) is not less than $250,000,000, and (iii) except in the case of a merger or other transaction pursuant to which Infinity Pharmaceuticals, Inc. is the surviving entity, such assignee shall agree in writing to assume all of the terms, covenants and conditions of this Lease arising after the effective date of the assignment (a “ Corporate Permitted Assignment ”). Control Permitted Assignments and Corporate Permitted Assignments are hereinafter referred to as “ Permitted Assignments .”

Notwithstanding anything to the contrary contained in this Section 22 , Tenant shall have the right, without Landlord’s consent, but on prior written notice to Landlord, to permit (x) certain institutions and companies collaborating with Tenant (collectively, the “ Research Parties ”), and (y) certain vendors providing services to Tenant (collectively, “ Service Providers ”), to occupy a portion of the Premises during the Term not to exceed 15% of the Premises at any one time, subject to all of the following conditions: (i) the use of the Premises by all Research Parties and Service Providers is in a manner consistent with the use permitted under this Lease; (ii) no demising walls or separate entrances shall be constructed in the Premises to accommodate the Research Parties or Service Providers, and (iii) Tenant shall not collect any rent from any Research Parties or Service Providers. Tenant shall be fully responsible for the acts of all Research Parties, Service Providers and their invitees at the Project and under no circumstances shall Landlord have any liability to any Research Parties and/or Service Providers in connection with any of the rights granted to Research Parties and Service Providers under this paragraph and the Research Parties and Service Providers waive any claim that the Research Parties and Service Providers, as applicable, may now or in the future have against Landlord in connection with the occupancy by such Research Parties and Service Providers of a portion of the Premises pursuant to this paragraph. Notwithstanding anything to the contrary contained in this Lease, the right of any Research Parties or Service Providers to occupy a portion of the Premises shall remain subject to and subordinate to the terms of this Lease. Tenant shall be fully responsible for the acts of all Research Parties and Service Providers pursuant to this paragraph and Landlord shall have no liability to or in connection with any Research Parties or Service Providers.”

d. Notwithstanding anything to the contrary contained in the Lease, Tenant shall not be required to pay any Excess Rent to Landlord in connection with any Excess Rent paid by a sublessee or assignee pursuant to a Permitted Assignment.

e. Notwithstanding anything to the contrary contained in the Lease or in this Seventh Amendment, whether or not Landlord’s prior consent to such assignment or subletting is required, Tenant shall at all times remain fully and primarily responsible and liable for the payment of Rent and for compliance with all of Tenant’s other obligations under the Lease.

 

14. Signage . In addition to the signage rights granted to Tenant pursuant to Section 38 of the Lease, Tenant shall have the exclusive right to display, at Tenant’s sole cost and expense and otherwise subject to the terms and conditions of this Section 14 , signage bearing Tenant’s name on the 780

 

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Building ( “780 Building Sign ). Tenant further acknowledges and agrees that the 780 Building Sign including, without limitation, the location, size, color and type, shall be subject to Landlord’s prior written approval, which shall not be unreasonably withheld and shall be subject to and in compliance with Landlord’s signage program at the Project, if any, and applicable Legal Requirements. Landlord agrees that Tenant’s existing corporate logo and branding as of the date of this Seventh Amendment is hereby deemed approved for the purposes of color and design for signage purposes. Tenant shall be responsible, at Tenant’s sole cost and expense, for the maintenance of the 780 Building Sign, for the removal of the 780 Building Sign at the expiration or earlier termination of the Lease and for the repair all damage resulting from such removal.

 

15. Self-Help . Notwithstanding anything to the contrary contained in the Lease, if any claimed Landlord default hereunder will immediately, materially and adversely affect Tenant’s ability to conduct its business in the Premises (a “Material Landlord Default” ), Tenant shall, as soon as reasonably possible, give Landlord written notice of such claim which notice shall specifically state that a Material Landlord Default exists and telephonic notice to Tenant’s principal contact with Landlord. Landlord shall then have 2 business days to commence cure of such claimed Material Landlord Default and shall diligently prosecute such cure to completion. If such claimed Material Landlord Default is not a default by Landlord hereunder, Landlord shall be entitled to recover from Tenant, as Additional Rent, any costs incurred by Landlord in connection with such cure in excess of the costs, if any, that Landlord would otherwise have been liable to pay hereunder. If Landlord fails to commence or diligently prosecute the cure of any claimed Material Landlord Default as provided above, Tenant may commence and prosecute such cure to completion provided that it does not affect any Building Systems affecting other tenants, the structure of the 780 Building, the structure of the 790 Building, or Common Areas, and shall be entitled to recover the costs of such cure (but not any consequential or other damages) from Landlord by way of reimbursement from Landlord which shall be made within 30 days’ after Tenant’s delivery of an invoice and any additional documentation reasonably requested by Landlord, with no right to offset against Rent, to the extent of Landlord’s obligation to cure such claimed Material Landlord Default hereunder, subject to the limitations set forth in the immediately preceding sentence of this paragraph and the other provisions of the Lease.

 

16. Early Termination Rights . Notwithstanding anything to the contrary contained herein or in the Lease, as of the date of this Seventh Amendment, Section 6 of the Fifth Amendment is hereby deleted in its entirety and is null and void and of no further force or effect.

 

17. Inspection and Access . Landlord shall comply with Tenant’s reasonable security requirements including, without limitation, the use of identification badges and identification verification, if applicable with respect to entering the Premises; provided, however, that Tenant has notified Landlord of such security requirements prior to Landlord’s entry into the Premises.

 

18. Roof Rights . Section 39 of the original Lease is hereby deleted in its entirety and replaced with the following:

“39. Roof Equipment . As long as Tenant is not in default under this Lease, beyond any applicable notice and cure periods Tenant shall have the right at its sole cost and expense subject to compliance with all Legal Requirements, to install, maintain, and remove on the top of the roof of the 780 Building and 790 Building (based, in each case, on Tenant’s proportionate share of the space available for tenants on the applicable roof) in a location determined by Landlord one or more satellite dishes for Tenant’s use (having a diameter and height reasonably acceptable to Landlord), communication antennae, or other equipment (all of which having a diameter and height reasonably acceptable to Landlord) for the transmission or reception of communication of signals as Tenant may from time to time desire or for other reasonably customary rooftop equipment purposes in connection with Tenant’s use of the Premises for the Permitted Use (such as supplemental HVAC units)( collectively, the “ Roof Equipment ”) on the following terms and conditions:

 

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(a) Requirements . Tenant shall submit to Landlord (i) the plans and specifications for the installation of the Roof Equipment, (ii) copies of all required governmental and quasi-governmental permits, licenses, and authorizations that Tenant will and must obtain at its own expense, with the cooperation of Landlord, if necessary for the installation and operation of the Roof Equipment, and (iii) an insurance policy or certificate of insurance evidencing insurance coverage as required by this Lease and any other insurance as reasonably required by Landlord for the installation and operation of the Roof Equipment. Landlord shall not unreasonably withhold, condition or delay its approval for the installation and operation of the Roof Equipment; provided , however , that Landlord may reasonably withhold its approval if the installation or operation of the Roof Equipment (A) may damage the structural integrity of the 780 Building or the 790 Building, as applicable, (B) may void, terminate, or invalidate any applicable roof warranty, (C) may interfere with any service provided by Landlord or any tenant of the 780 Building or the 790 Building, as applicable, (D) may reduce the then-existing leasable space in the 780 Building or the 790 Building, or (E) is not properly screened from the viewing public.

(b) No Damage to Roof . If installation of the Roof Equipment requires Tenant to make any roof cuts or perform any other roofing work, such cuts shall only be made to the roof area of the 780 Building or the 790 Building, as applicable, in locations reasonably acceptable to Landlord and only in the manner reasonably designated in writing by Landlord; and any such installation work (including any roof cuts or other roofing work) shall be performed by Tenant, at Tenant’s sole cost and expense by a roofing contractor designated by or otherwise reasonably acceptable to Landlord. If Tenant or its agents shall otherwise cause any damage to the roof during the installation, operation, and removal of the Roof Equipment such damage shall be repaired promptly at Tenant’s expense and the roof shall be restored in the same condition it was in before the damage. Landlord shall not charge Tenant Additional Rent for the installation and use of the Roof Equipment. If, however, Landlord’s insurance premium or Tax assessment increases as a result of the Roof Equipment, Tenant shall remove such equipment or pay such increase as Additional Rent within ten (10) days after receipt of a reasonably detailed invoice and other evidence of such increase reasonably requested by Tenant from Landlord. Tenant shall not be entitled to any abatement or reduction in the amount of Rent payable under this Lease if for any reason Tenant is unable to use the Roof Equipment. In no event whatsoever shall the installation, operation, maintenance, or removal of the Roof Equipment by Tenant or its agents void, terminate, or invalidate any applicable roof warranty.

(c) Protection . The installation, operation, and removal of the Roof Equipment shall be at Tenant’s sole risk. Tenant shall indemnify, defend, and hold Landlord harmless from and against any and all claims, costs, damages, liabilities and expenses (including, but not limited to, attorneys’ fees) of every kind and description that may arise out of or be connected in any way with Tenant’s installation, operation, or removal of the Roof Equipment.

(d) Removal . At the expiration or earlier termination of this Lease or the discontinuance of the use of the Roof Equipment by Tenant, if the Roof Equipment is not customary for typical office or laboratory use or is not in good order and repair, all as reasonably determined by Landlord, Tenant shall, at its sole cost and expense, remove the Roof Equipment from the 780 Building and/or the 790 Building, as applicable. Tenant shall leave the portion of the roof where the Roof Equipment was located in substantially the same condition as such portion of the roof was prior to the installation of the Roof Equipment. If Tenant does not so remove the Roof Equipment, Tenant hereby authorizes Landlord to remove and dispose of the Roof Equipment and charge Tenant as Additional Rent for all costs and expenses incurred by Landlord in such removal and disposal. Tenant agrees that Landlord shall not be liable for any Roof Equipment or related property disposed of or removed by Landlord.

(e) No Interference . The Roof Equipment shall not interfere with the proper functioning of any currently existing equipment or devices that have been installed by Landlord or for any other tenant of the 790 Building existing as of the date of this Seventh Amendment. Tenant agrees that

 

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any other tenant of the 780 Building or the 790 Building, as applicable, that currently has or in the future takes possession of any portion of the 780 Building or the 790 Building, as applicable, will be permitted to install such telecommunication equipment that is of a type and frequency that will not cause adverse interference to the Roof Equipment.

(f) Relocation . Landlord shall have the right, at its expense and after 60 days prior notice to Tenant, to relocate (i) the Roof Equipment located on the roof of the 780 Building to another site on the roof of the 780 Building, and (ii) the Roof Equipment located on the roof of the 790 Building to another site on the roof of the 790 Building, in each case as long as such site reasonably meets Tenant’s sight line and interference requirements and does not unreasonably interfere with Tenant’s use and operation of the Roof Equipment.

(g) Access . Landlord grants to Tenant the right of ingress and egress on a 24 hour 7 day per week basis to install, operate, and maintain the Roof Equipment. So long as the 790 Building remains a multi-tenant building, before receiving access to the roof of the 790 Building, Tenant shall give Landlord at least 24 hours’ advance written or oral notice, except in emergency situations, in which case 2 hours’ advance oral notice shall be given by Tenant. Landlord shall supply Tenant with the name, telephone, and pager numbers of the contact individual(s) responsible for providing access during emergencies.

(h) Appearance . If permissible by Legal Requirements, Landlord may require that the Roof Equipment visible from street level shall, at Landlord’s reasonable election, be screened or painted, at Tenant’s cost, the same color as the 780 Building or the 790 Building, as applicable.

(i) No Assignment. The right of Tenant to use and operate the Roof Equipment shall be personal solely to Infinity Pharmaceutics, Inc., and (i) except in connection with a Permitted Assignment or in connection with a sublease or assignment approved by Landlord pursuant to Section 22 of the Lease, no other person or entity shall have any right to use or operate the Roof Equipment, and (ii) except in connection with a Permitted Assignment or in connection with an assignment or sublease approved by Landlord pursuant to Section 22 of the Lease, Tenant shall not assign, convey, or otherwise transfer to any person or entity any right, title, or interest in all or any portion of the Roof Equipment or the use and operation thereof.”

 

19. Expansion Rights . Section 4 of the Fifth Amendment is hereby deleted in its entirety and replaced with the following:

“4. Right to Expand .

(a) Expansion in the 790 Building. Commencing in the calendar year 2015, after July 1 st and prior to November 30 th of each calendar year during the Base Term through November 30, 2022, Tenant may deliver to Landlord a written inquiry regarding whether Landlord anticipates that any space in the 790 Building will become available for lease by Tenant during the immediately following calendar year. Within 10 business days after receipt of Tenant’s inquiry, Landlord shall deliver to Tenant a written notice ( “Potential Space Identification Notice” ) identifying (i) the rentable square footage and location within the 790 Building of any space occupied by a then existing tenant whose lease is expiring during the immediately following calendar year ( “Potential Available 790 Space” ), (ii) whether the lease pursuant to which the Potential Available 790 Space is then subject contains a right to renew, and (iii) on what date such Potential Available 790 Space would become available if the lease contains a right to renew and the then existing tenant does not renew its occupancy of the Potential Available 790 Space ( “Availability Date” ). Tenant shall deliver a written notice to Landlord within 10 business days after Tenant’s receipt of Landlord’s Potential Space Identification Notice if Tenant desires to lease the Potential Available 790 Space ( “Tenant Interest Notice ). With respect to any Potential Available 790 Space subject to a lease that contains a right to renew, Tenant’s rights under this Section 4(a) shall be subject to the election of any such then existing tenant to renew or

 

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otherwise extend its occupancy of such Potential Available 790 Space and if such then existing tenant elects to renew or otherwise extend its occupancy of the Potential Available 790 Space, Tenant shall have no right to lease such Potential Available 790 Space.

If Tenant has timely delivered a Tenant Interest Notice to Landlord with respect to a Potential Available 790 Space and the then existing tenant does not elect to renew its occupancy of the Potential Available 790 Space, then, on or before the date that is 15 business days after the then existing tenant of the Potential Available 790 Space waives its right or is deemed to have waived its right to renew its occupancy of the Potential Available 790 Space, if at all, Landlord shall deliver to Tenant a written notice identifying such Potential Available 790 Space as available for lease by Tenant (“ Available 790 Space ”), together with the terms and conditions on which Landlord is prepared to lease Tenant such Available 790 Space including, without limitation, the term for which Landlord is willing to Lease such Available 790 Space and Landlord’s good faith estimate of the Market Rate (as defined below) for such Available 790 Space (“ Expansion Notice ”). Notwithstanding the foregoing, if Tenant delivers a Tenant Interest Notice pursuant to the preceding paragraph with respect to Potential Available 790 Space then subject to a lease that does not contain a right to renew, then such space shall immediately constitute Available 790 Space and Landlord shall deliver an Expansion Notice to Tenant within 15 business days after Landlord’s receipt of the Tenant Interest Notice with respect to such Available 790 Space. If Landlord delivers to Tenant an Expansion Notice, Tenant shall have the right, but not the obligation, to elect to expand the Premises (each, an “ Expansion Right ”) to include any such Available 790 Space upon the terms and conditions in this Section 4 . Tenant shall be entitled to exercise its right under this Section 4(a) only with respect to the entire Available 790 Space described in such Expansion Notice. Notwithstanding anything to the contrary contained herein, the initial Base Rent for the Available 790 Space shall be payable at the Market Rate. Base Rent shall thereafter be adjusted on each annual anniversary of the commencement date of the Lease with respect to the Available 790 Space by a percentage as determined by Landlord and agreed to by Tenant at the time the Market Rate is determined. As used herein, “ Market Rate ” shall mean the then market rental rate as determined pursuant to Section 41 of the original Lease. Tenant shall have 15 business days following delivery of the Expansion Notice to deliver to Landlord written notification of Tenant’s exercise of the Expansion Right (“ Acceptance Notice ”). If Tenant delivers such notice to Landlord in a timely manner, Tenant shall be entitled to lease such Available 790 Space upon the terms and conditions set forth in the Expansion Notice and at the Market Rate. Tenant’s failure to deliver an Acceptance Notice to Landlord shall be deemed to be an election by Tenant not to exercise Tenant’s Expansion Right with respect to the Available 790 Space identified in Landlord’s Expansion Notice, in which case Landlord shall have the right to lease the Available 790 Space to any third party on any terms and conditions acceptable to Landlord; provided, however, that if (i) Landlord intends to lease the Available 790 Space to a third party for less than ninety percent (90%) of the net effective rent contained in the Expansion Notice, or (ii) Landlord has not entered into a lease with a third party for the Available 790 Space within 9 months following the date of the Expansion Notice, then prior to leasing the Available 790 Space to a third party, Landlord shall again give Tenant an Expansion Notice and Tenant shall again have its Expansion Right with respect to the Available 790 Space, subject to the terms and conditions of this Section 4(a) .

(b) Amended Lease. Following the timely and proper exercise of the Expansion Right, the parties shall promptly enter into an amendment to this Lease evidencing the same. If: (i) Tenant fails to timely deliver notice accepting the terms of an Expansion Notice, or (ii) after the expiration of a period of 30 days from the date Tenant delivers an Acceptance Notice to Landlord, no Lease amendment for the Available 790 Space has been executed and Landlord tenders to Tenant an amendment to this Lease setting forth the terms for the rental of the Available 790 Space consistent with those set forth in the Expansion Notice and otherwise consistent with the general terms and conditions of the Lease (and for the avoidance of doubt, which do not include abatements of Rent, the Base Building Allowance, the Additional Allowance, any other tenant improvement allowances or work letters) and Tenant fails to execute such Lease amendment within 10 business days following such tender, then Tenant shall be deemed to have waived its right to lease such Available 790 Space.

 

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(c) Exceptions. Notwithstanding the above, the Expansion Right shall, at Landlord’s option, not be in effect and may not be exercised by Tenant:

(i) during any period of time that Tenant is in Default under any provision of the Lease; or

(ii) if Tenant has been in Default under any provision of the Lease 3 or more times in the payment of Rent, whether or not the Defaults are cured, during the 12 month period prior to the date on which Tenant seeks to exercise the Expansion Right.

(d) Termination. The Expansion Right shall, at Landlord’s option, terminate and be of no further force or effect even after Tenant’s due and timely exercise of the Expansion Right, if, after such exercise, but prior to the commencement date of the lease of such Available 790 Space, (i) Tenant fails to timely cure any default by Tenant under the Lease for which Tenant has received notice; or (ii) Tenant has Defaulted 3 or more times in the payment of Rent during the period from the date of the exercise of the Expansion Right to the date of the commencement of the lease of the Available 790 Space, whether or not such Defaults are cured.

(e) Rights Personal. Expansion Rights are personal to Tenant and are not assignable without Landlord’s consent, which may be granted or withheld in Landlord’s sole discretion separate and apart from any consent by Landlord to an assignment of Tenant’s interest in the Lease, except that they may be assigned in connection with any Permitted Assignment of this Lease.

(f) No Extensions. The period of time within which any Expansion Rights may be exercised shall not be extended or enlarged by reason of Tenant’s inability to exercise the Expansion Rights.”

 

20. Financial Information . So long as Tenant is a “public company” and its financial information is publicly available, then the delivery requirements of Section 42(c) of the Lease shall not apply.

 

21. Recordation . Within a reasonable period following Tenant’s delivery to Landlord of an executed original of this Seventh Amendment, Landlord shall deliver to Tenant an amendment to the existing Notice of Lease dated July 2, 2002, in the form attached to this Seventh Amendment as Exhibit E (“Amended Notice of Lease” ), executed and acknowledged by Landlord, which Tenant may cause the Amended Notice of Lease to be recorded, at Tenant’s sole cost and expense, in the Middlesex South Registry of Deeds.

 

22. Fitness Center . Tenant acknowledges and agrees that only individuals that are entitled to occupy the portion of the Premises located within the 790 Building under the Lease on a full-time basis shall have the right to use of the common fitness room located within the 790 Building. The use of the fitness room by Tenant’s employees shall be subject to all reasonable rules and regulations established by Landlord with respect to the use of the fitness room.

 

23. Shuttle . Landlord shall consult with Tenant when establishing shuttle schedules for the Project. Tenant may elect to hire its own shuttle services; provided, however, that Tenant’s hired shuttle services shall (i) be at Tenant’s sole cost and expense, (ii) be available for use by all tenants of the Project, (iii) pick up and drop off users of the shuttle service at all of the shuttle stops existing as of the date of this Seventh Amendment, (iv) be consistent with the service standards existing with respect to the existing shuttle services as of the date of this Seventh Amendment, and (v) comply with all requirements of the PTDM. If Tenant elects to hire its own shuttle service pursuant to the immediately preceding sentence, for the period that Tenant continues to run its own shuttle service, Tenant shall no longer have a right to use any shuttle service provided by Landlord, if any, and shall not be required to pay for Landlord’s shuttle services.

 

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24. Landlord’s Repairs . Notwithstanding anything to the contrary contained herein, so long as Tenant is the only Tenant leasing space in the 780 Building, the vendors used by Landlord in connection with Landlord maintenance requirements under Section 13 of the Lease with respect to the 780 Building ( “Building 780 Vendors” ) shall be reasonably acceptable to Tenant. All Building 780 Vendors under contract for services to the 780 Building as of the date of this Seventh Amendment are hereby deemed approved by Tenant. If Landlord intends to commence using a new vendor with respect to the 780 Building, Landlord shall provide Tenant with written notice thereof ( “Proposed 780 Vendor Notice” ), which Proposed 780 Vendor Notice shall identify the proposed vendor, the scope of services the proposed vendor will provide and the estimated cost of such services. Tenant shall have the right to reasonably object to Landlord’s use of the vendor identified in a Proposed 780 Vendor Notice by delivery of written notice to Landlord of Tenant’s objection and the reasons therefor within 3 days after Landlord’s delivery to Tenant of a Proposed 780 Vendor Notice. If Landlord does not receive an objection notice from Tenant within such 3-day period, Tenant shall be deemed to have approved the vendor identified in such Proposed 780 Vendor Notice.

 

25. Environmental Items . If Tenant delivers to Landlord written notice, along with evidence reasonably acceptable to Landlord, of the existence of Hazardous Materials at the Project which materially and adversely affects Tenant’s use of the Premises for the Permitted Use and requiring remediation pursuant to applicable Legal Requirements and Tenant can prove that the presence of such Hazardous Materials was not caused by, contributed to or exacerbated by Tenant or any Tenant Party, Landlord shall investigate such claim of Tenant and, if applicable, Landlord shall cause the remediation of (or use reasonable efforts to cause the responsible party to remediate) such Hazardous Materials requiring remediation pursuant to applicable Legal Requirements in a manner acceptable to Landlord in its sole and absolute discretion and otherwise in compliance with applicable Legal Requirements. Nothing in this Section 25 shall preclude Landlord from passing through the cost of such investigation and/or remediation as part of Operating Expenses (except to the extent the cost thereof is excluded from Operating Expenses pursuant to Section 5 of the Lease).

 

26. Intentionally Omitted .

 

27. Brokers . Landlord and Tenant each represents and warrants that it has not dealt with any broker, agent or other person (collectively, “ Broker ”) in connection with the transaction reflected in this Seventh Amendment and that no Broker brought about this transaction, other than CBRE-NE. Landlord and Tenant each hereby agrees to indemnify and hold the other harmless from and against any claims by any Broker (other than the brokers named in this Section 27 ) claiming a commission or other form of compensation by virtue of having dealt with Tenant or Landlord, as applicable, with regard to this leasing transaction. Landlord shall be responsible for all commissions due to CBRE-NE arising out of the execution of this Lease in accordance with the terms of a separate written agreement between CBRE-NE and Landlord.

 

28. Miscellaneous .

a. This Seventh 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. This Seventh Amendment may be amended only by an agreement in writing, signed by the parties hereto.

b. This Seventh Amendment is binding upon and shall inure to the benefit of the parties hereto and their respective successors and assigns.

 

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c. This Seventh 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 Seventh Amendment attached thereto.

d. Except as amended and/or modified by this Seventh 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 Seventh Amendment. In the event of any conflict between the provisions of this Seventh Amendment and the provisions of the Lease, the provisions of this Seventh Amendment shall prevail. Whether or not specifically amended by this Seventh 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 Seventh Amendment.

[Signatures are on the next page.]

 

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IN WITNESS WHEREOF , the parties hereto have executed this Seventh Amendment as of the day and year first above written.

 

TENANT:

INFINITY PHARMACEUTICALS, INC.,

a Delaware corporation

By:  

/s/ Adelene Perkins

Its:   Chairman and Chief Executive Officer
LANDLORD:

ARE-770/784/790 MEMORIAL DRIVE, 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:  

/s/ Jackie Clem

    Its:   VP Real Estate Legal Affairs

 

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20


Exhibit A

Surrender Premises

 

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Exhibit B

Preliminary Base Building Alterations Scope of Work

Proposed Scope Outline of Base Building Improvements to be carried out at 780 Memorial Drive. Landlord will have prior approval of actual new or replacement equipment.

HVAC Projects:

Heat Recovery Systems installation, including installation of central exhaust system

Chiller replacement or upgrade, including elimination of the use of ozone-depleting refrigerant such as R-22; increasing capacity

Boiler replacement or upgrade to more efficient models

AHU replacement or upgrade/Installation of redundant air handling capacity

HVAC Controls/Programming

Electrical Projects:

LED Lighting upgrades

Lighting -installation of motion sensors in common areas

Emergency Generator replacement or upgrade (if tenant can document need and project is approved by landlord prior to replacement/upgrade)

Installation of lightning protection system

Plumbing Projects:

Restroom upgrades

Hot water heater replacement, may include tank-less systems

pH neutralization system upgrades when full system replacement is needed

 

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B-1


Exhibit C

Intentionally Omitted

 

 

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C-1


Exhibit D

Additional Personal Property

Landlord and Tenant agree that the equipment described below may be removed by Tenant from the Premises, in each case except where such equipment was purchased using the Tenant Improvement Allowance:

Centrifuges

Freezers

Refrigerators

Bio Safety Cabinets

Incubators

Animal Cages and Racks

Freeze Dry Systems

Computer Servers and server racks

All other laboratory equipment, furniture and other equipment (not including lab hoods or benches) that is similar in nature to those listed above that are placed in the Premises by Tenant following the initial Tenant Work.

 

 

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Exhibit E

Amendment to Notice of Lease

AMENDMENT TO NOTICE OF LEASE

As of November     , 2014

This Amendment to Notice of Lease amends that certain Notice of Lease (the “Notice”) dated July 2, 2002 by and between ARE-770/784/790 Memorial Drive, LLC, as Landlord, and Infinity Pharmaceuticals, Inc., as Tenant, recorded with the Middlesex South Registry of Deeds at Book                     , Page                     , and the Middlesex South Registry District of the Land Court as Document No.                     .

Pursuant to Section 4 of Chapter 183 of the General Laws of Massachusetts, notice is hereby given of the following amendments to the Notice:

 

Date of Lease:    The Date of Lease as set forth in the Notice is hereby amended and restated in its entirety as follows: “July 2, 2002, as amended by that certain First Amendment to Lease dated March 25, 2003, as further amended by that certain Second Amendment to Lease dated April 30, 2003, as further amended by that certain Third Amendment to Lease dated October 30, 2003, as further amended by that certain Fourth Amendment to Lease dated December 15, 2003, as further amended by that certain Fifth Amendment to Lease dated as of July 8, 2011, as further amended by that certain Sixth Amendment to Lease dated as of June 1, 2012, and as amended by that certain Seventh Amendment to Lease as of the date hereof (collectively, as it may be amended, the “Lease”).”
Premises:    The Premises as set forth in the Notice is hereby amended and restated in its entirety as follows: “The (a) first, second and third floors of 780 Memorial Drive (formerly known as 770 Memorial Drive), and (b) portions of the first floor and third floor of 790 Memorial Drive, as more particularly described in the Lease.”
Term:    The Term as set forth in the Notice is hereby amended and restated in its entirety as follows: “The term of the Lease commenced on                     and expires on March 31, 2025, with two consecutive rights to extend the term for five (5) years each as further described in the Lease.”

This Amendment to Notice of Lease is executed only for the purpose of giving notice of the existence of the Lease and is not intended to modify, expand or reduce any of the rights of Landlord and Tenant as set forth in the Lease. Except as expressly set forth herein, the Notice remains in full force and affect.

[The balance of this page has been intentionally left blank.]

 

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EXECUTED under seal as of the date first above written.

LANDLORD:

ARE-770/784/790 MEMORIAL DRIVE, LLC,

a Delaware limited liability company

 

By:   Alexandria Real Estate Equities, L.P., managing member
  By:   ARE-QRS Corp., general partner
    By:  

 

    Name:  

 

    Title:  

 

 

TENANT:

INFINITY PHARMACEUTICALS, INC.

a Delaware corporation

By:    
Name:  
Title:  

 

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State of California   }     

County of                                                                       

On                                         before me,                                                                                                                                                          ,

                        Date                                                          Here Insert Name and Title of the Officer

personally appeared                                                                                                                                                                               
Name(s) of Signer(s)
    ,

 

  

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.

 

Signature                                                                                                            

Place Notary Seal Above

   Signature of Notary Public

COMMONWEALTH OF MASSACHUSETTS

                    , ss.

On this                     day of                     , 20        , before me, the undersigned notary public, personally appeared                     (name of document signer), proved to me through satisfactory evidence of identification, which were                     , to be the person whose name is signed on the preceding or attached document, and acknowledged to me that (he) (she) signed it voluntarily for its stated purpose[, (as partner for             , a corporation) (as             for             , a corporation) (as attorney in fact for                     , the principal) (as                     for                     , (a) (the)                     )].

                    (official signature and seal of notary)

My commission expires                     

 

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Exhibit A

 

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Exhibit 31.1

CERTIFICATION PURSUANT TO RULES 13A-14(A) AND 15D-14(A)

UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

I, Adelene Q. Perkins, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Infinity Pharmaceuticals, Inc. (the “Registrant”);

2. Based on my knowledge, this quarterly 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 quarterly report;

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly report;

4. The Registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

(a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this quarterly report is being prepared;

(b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this quarterly report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and

(d) disclosed in this quarterly report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s third fiscal quarter 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(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions):

(a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and

(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

 

Date: November 10, 2014       /s/ A DELENE Q. P ERKINS
      Adelene Q. Perkins
      President and Chief Executive Officer
      (Principal Executive Officer)

Exhibit 31.2

CERTIFICATION PURSUANT TO RULES 13A-14(A) AND 15D-14(A)

UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

I, Lawrence E. Bloch, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Infinity Pharmaceuticals, Inc. (the “Registrant”);

2. Based on my knowledge, this quarterly 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 quarterly report;

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly report;

4. The Registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

(a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this quarterly report is being prepared;

(b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this quarterly report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and

(d) disclosed in this quarterly report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s third fiscal quarter 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(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions):

(a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and

(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

 

Date: November 10, 2014       /s/ L AWRENCE E. B LOCH , M.D., J.D.
      Lawrence E. Bloch, M.D., J.D.
     

Executive Vice President, Chief Financial Officer and

Chief Business Officer

      (Principal Financial Officer & Principal Accounting Officer)

Exhibit 32.1

STATEMENT PURSUANT TO 18 U.S.C. §1350, AS ADOPTED

PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Pursuant to 18 U.S.C. §1350, the undersigned certifies that, to her knowledge, this Quarterly Report on Form 10-Q for the period ended September 30, 2014 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that, to her knowledge, the information contained in this report fairly presents, in all material respects, the financial condition and results of operations of Infinity Pharmaceuticals, Inc.

 

Date: November 10, 2014       /s/ A DELENE Q. P ERKINS
      Adelene Q. Perkins
      President and Chief Executive Officer
      (Principal Executive Officer)

A signed original of this written statement required by Section 906 has been provided to Infinity Pharmaceuticals, Inc. and will be retained by Infinity Pharmaceuticals, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

Exhibit 32.2

STATEMENT PURSUANT TO 18 U.S.C. §1350, AS ADOPTED

PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Pursuant to 18 U.S.C. §1350, the undersigned certifies that, to his knowledge, this Quarterly Report on Form 10-Q for the period ended September 30, 2014 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that, to his knowledge, the information contained in this report fairly presents, in all material respects, the financial condition and results of operations of Infinity Pharmaceuticals, Inc.

 

Date: November 10, 2014       /s/ L AWRENCE E. B LOCH , M.D., J.D.
      Lawrence E. Bloch, M.D., J.D.
     

Executive Vice President, Chief Financial Officer and

Chief Business Officer

      (Principal Financial Officer & Principal Accounting Officer)

A signed original of this written statement required by Section 906 has been provided to Infinity Pharmaceuticals, Inc. and will be retained by Infinity Pharmaceuticals, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.