Table of Contents

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
     
þ   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2011
OR
     
o   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from            to
Commission File Number: 001-33958
RXi Pharmaceuticals Corporation
(Exact name of registrant as specified in its charter)
     
Delaware   20-8099512
(State of incorporation)   (I.R.S. Employer Identification No.)
60 Prescott Street, Worcester, MA 01605
(Address of principal executive office) (Zip code)
Registrant’s telephone number: (508) 767-3861
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 þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on it 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 time that the registrant was required to submit and post such files).
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
             
Large accelerated filer o   Accelerated filer o   Non-accelerated filer o   Smaller reporting company þ
        (Do not check if a smaller reporting company)    
Indicate by checkmark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No þ
As of August 11, 2011, RXi Pharmaceuticals Corporation had 41,986,800 shares of common stock, $0.0001 par value, outstanding.
 
 

 


 

RXi PHARMACEUTICALS CORPORATION
FORM 10-Q — QUARTER ENDED June 30, 2011
INDEX
                 
            Page
Part No.   Item No.   Description   No.
      FINANCIAL INFORMATION        
 
               
 
  1   Financial Statements     2  
 
               
 
      Condensed Consolidated Balance Sheets as of June 30, 2011 and December 31, 2010 (unaudited)     2  
 
               
 
      Condensed Consolidated Statements of Expenses for the three months ended June 30, 2011 and 2010, the six months ended June 30, 2011 and 2010, and the cumulative amounts for the period January 1, 2003 (date of inception) to June 30, 2011 (unaudited)     3  
 
               
 
      Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2011 and 2010 and the cumulative amounts for the period January 1, 2003 (date of inception) to June 30, 2011(unaudited)     4  
 
               
 
      Notes to Condensed Consolidated Financial Statements (unaudited)     7  
 
               
 
  2   Management’s Discussion and Analysis of Financial Condition and Results of Operations     17  
 
               
 
  4   Controls and Procedures     19  
 
               
      OTHER INFORMATION        
 
               
 
  1   Legal Proceedings     21  
 
               
 
  1A   Risk Factors     21  
 
               
 
  2   Unregistered Sales of Equity Securities and Use of Proceeds     21  
 
               
 
  3   Defaults Upon Senior Securities     21  
 
               
 
  4   (Removed and Reserved)     21  
 
               
 
  5   Other Information     21  
 
               
 
  6   Exhibits     21  
 
               
Index to Exhibits     21  
 
               
Signatures     22  
  EX-4.2
  EX-10.1
  EX-10.2
  EX-10.3
  EX-10.4
  EX-10.5
  EX-10.6
  EX-10.8
  EX-10.9
  EX-10.10
  EX-10.11
  EX-10.12
  EX-31.1
  EX-31.2
  EX-32.1
  EX-101 INSTANCE DOCUMENT
  EX-101 SCHEMA DOCUMENT
  EX-101 CALCULATION LINKBASE DOCUMENT
  EX-101 LABELS LINKBASE DOCUMENT
  EX-101 PRESENTATION LINKBASE DOCUMENT

 


Table of Contents

PART I
ITEM 1.   FINANCIAL STATEMENTS
RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
(Unaudited)
                 
    June 30,     December 31,  
    2011     2010  
ASSETS
               
 
               
Current assets:
               
 
               
Cash and cash equivalents
  $ 17,933     $ 6,891  
Prepaid expenses and other current assets
    259       150  
 
           
 
               
Total current assets
    18,192       7,041  
 
           
 
               
Equipment and furnishings, net
    436       419  
In-process research & development (Note 2)
    12,864        
Goodwill
    845        
Deposits
    16       16  
 
           
 
               
Total assets
  $ 32,353     $ 7,476  
 
           
 
               
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities:
               
Accounts payable
  $ 1,065     $ 724  
Accrued expenses and other current liabilities
    1,785       1,113  
Deferred revenue
    578        
Current maturities of capital lease obligations
    59       51  
Fair value of stock options modified (Note 7)
    682        
Fair value of warrants potentially settleable in cash (Note 7)
    11,882       3,138  
Current contingent purchase price consideration
    768        
 
           
Total current liabilities
    16,819       5,026  
Capital lease obligations, net of current maturities
    10       20  
Contingent purchase price consideration, net of current portion
    5,664        
 
           
 
               
Total liabilities
    22,493       5,046  
 
           
 
               
Commitments and contingencies (Note 6)
               
Stockholders’ equity:
               
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding
           
Common stock, $0.0001 par value; 50,000,000 shares authorized; 42,511,800 shares issued and 41,836,800 shares outstanding and 19,047,759 shares issued and 18,372,759 outstanding at June 30, 2011 and December 31, 2010, respectively
    4       2  
Additional paid-in capital
    74,675       62,020  
Deficit accumulated during the developmental stage
    (60,970 )     (55,743 )
Less treasury shares at cost, 675,000 shares
    (3,849 )     (3,849 )
 
           
 
               
Total stockholders’ equity
    9,860       2,430  
 
           
 
               
Total liabilities and stockholders’ equity
  $ 32,353     $ 7,476  
 
           
The accompanying notes are an integral part of these financial statements.

2


Table of Contents

RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF EXPENSES
(Amounts in thousands, except share and per share data)
(Unaudited)
                                         
                                Period from  
                            January 1,  
    For the Three     For the Three     For the Six     For the Six     2003 (Date of  
    Months Ended     Months Ended     Months Ended     Months Ended     Inception) to  
    June 30,     June 30,     June 30,     June 30,     June 30,  
    2011     2010     2011     2010     2011  
Expenses:
                                       
Research and development expense
  $ 2,506     $ 1,484     $ 4,451     $ 2,983     $ 31,130  
Research and development employee stock based compensation expense
    212       267       458       540       2,865  
Research and development non-employee stock based compensation expense
    (45 )     513       (76 )     667       5,987  
Fair value of common stock issued in exchange for licensing rights
                            3,954  
 
                                       
Total research and development expenses
    2,673       2,264       4,833       4,190       43,936  
 
                                       
General and administrative
    1,610       1,654       3,531       3,102       24,641  
General and administrative employee stock based compensation
    328       646       1,427       1,418       8,812  
Common stock warrants issued for general and administrative expenses
    11       190       87       500       2,381  
Fair value of common stock issued in exchange for general and administrative expenses
                23             304  
Total general and administrative expenses
    1,949       2,490       5,068       5,020       36,138  
 
                                       
Operating loss
    (4,622 )     (4,754 )     (9,901 )     (9,210 )     (80,074 )
Interest income (expense)
    (3 )     3       (4 )     2       624  
Other income (Note 7)
    3,243       2,610       4,678       3,181       8,443  
 
                                       
Net loss
  $ (1,382 )   $ (2,141 )   $ (5,227 )   $ (6,027 )   $ (71,007 )
 
                                       
Net loss per common share:
                                       
Basic and diluted loss per share
  $ (0.04 )   $ (0.12 )   $ (0.18 )   $ (0.35 )     N/A  
 
                                       
Weighted average common shares outstanding:
                                       
Basic and diluted
    38,568,501       18,371,808       29,492,756       17,384,606       N/A  
The accompanying notes are an integral part of these financial statements.

3


Table of Contents

RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
(Unaudited)
                         
                    Period from  
                    January 1,  
                2003  
    For the Six     For the Six     (Date of  
    Months Ended     Months Ended     Inception)  
    June 30,     June 30,     Through  
    2011     2010     June 30, 2011  
Cash flows from operating activities:
                       
Net loss
  $ (5,227 )   $ (6,027 )   $ (71,011 )
Adjustments to reconcile net loss to net cash used in operating activities:
                       
Depreciation and amortization expense
    84       85       585  
Loss on disposal of equipment
    7             19  
Non-cash rent expense
                29  
Accretion and receipt of bond discount
                35  
Non-cash share-based compensation
    1,810       2,625       17,667  
Loss on exchange of equity instruments
    900             900  
Fair value of shares mandatorily redeemable for cash upon exercise of warrants
                (785 )
Fair value of common stock warrants issued in exchange for services
    87       500       2,381  
Fair value of common stock issued in exchange for services
    23             304  
Change in fair value of common stock warrants issued in connection with various equity financings
    (5,393 )     (3,181 )     (7,584 )
Fair value of common stock issued in exchange for licensing rights
                3,954  
Change in fair value of contingent purchase consideration
    (28 )           (28 )
Changes in assets and liabilities:
                       
Prepaid expenses
    (94 )     (190 )     (244 )
Accounts payable
    (590 )     (296 )     134  
Due to former parent
                (207 )
Deferred revenue
    578             578  
Accrued expenses and other current liabilities
    757       333       2,077  
 
                 
 
                       
Net cash used in operating activities
    (7,086 )     (6,151 )     (51,196 )
 
                 
 
                       
Cash flows from investing activities:
                       
Cash received in acquisition
    168             168  
Purchase of short-term investments
          (5,996 )     (37,532 )
Maturities of short-term investments
                37,497  
Cash paid for purchase of equipment and furnishings
    (53 )     (54 )     (739 )
Disposal of equipment and furnishings
                (1 )
Cash refunded (paid) for lease deposit
                (45 )
 
                 

4


Table of Contents

CONDENSED STATEMENTS OF CASH FLOWS
                         
                    Period from  
                    January 1,  
    For the Six             2003  
    Months     For the Six     (Date of  
    Ended     Months Ended     Inception)  
    June 30,     June 30,     Through  
    2011     2010     June 30, 2011  
Net cash provided by (used in) investing activities
    115       (6,050 )     (652 )
 
                 
 
                       
Cash flows from financing activities:
                       
Net proceeds from issuance of common stock
    18,060       15,235       64,427  
Cash paid for repurchase of common stock
          (3,849 )     (3,849 )
Net proceeds from exercise of common stock options
          255       610  
Repayments of capital lease obligations
    (47 )     (31 )     (173 )
Cash advances from former parent company, net
                8,766  
 
                 
 
                       
Net cash provided by financing activities
    18,013       11,610       69,781  
 
                 
 
                       
Net increase (decrease) in cash and cash equivalents
    11,042       (591 )     17,933  
Cash and cash equivalents at the beginning of period
    6,891       5,684        
 
                 
 
                       
Cash and cash equivalents at end of period
  $ 17,933     $ 5,093     $ 17,933  
 
                 
 
                       
Supplemental disclosure of cash flow information:
                       
Cash received during the period for interest
  $     $ 2     $ 724  
 
                 
 
                       
Cash paid during the period for interest
  $ 4     $     $ 11  
 
                 

5


Table of Contents

CONDENSED STATEMENTS OF CASH FLOWS
                         
                    Period From  
    For the     For the     January 1,  
    Six     Six     2003  
    Months     Months     (Date of  
    Ended     Ended     Inception)  
    June     June     through  
    30,     30,     June 30,  
    2011     2010     2011  
Supplemental disclosure of non-cash investing and financing activities:
                       
 
                       
Settlement of corporate formation expenses in exchange for common stock
  $     $     $ 978  
 
                 
 
                       
Fair value of warrants issued in connection with common stock recorded as a cost of equity
  $ 13,232     $ 2,466     $ 18,561  
 
                 
 
                       
Fair value of shares mandatorily redeemable for cash upon the exercise of warrants
  $     $ 785     $ 785  
 
                 
 
                       
Fair value of stock options modified
  $ 674     $     $ 674  
                   
Allocation of management expenses
  $     $     $ 551  
 
                 
 
                       
Equipment and furnishings exchanged for common stock
  $     $     $ 48  
 
                 
 
                       
Equipment and furnishings acquired through capital lease
  $ 44     $ 28     $ 241  
 
                 
 
                       
Value of restricted stock units and common stock issued in lieu of cash bonuses
  $     $ 207     $ 207  
 
                 
Value of restricted stock units and common stock issued in lieu of bonuses included in accrued expenses
  $ 427     $ 47     $ 474  
 
                 
 
                       
Non-cash lease deposit
  $     $     $ 50  
 
                 
Apthera Acquisition:
                       
Fair value of shares issued to acquire Apthera
  $ 6,367     $     $ 6,367  
 
                 
Fair value of contingent purchase price consideration in connection with Apthera acquisition
  $ 6,460     $     $ 6,460  
 
                 
Net assets acquired excluding cash of $168
  $ 12,827     $     $ 12,827  
 
                 
The accompanying notes are an integral part of these financial statements.

6


Table of Contents

RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Description of Business and Basis of Presentation
     RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics. RXi is pursuing the development of novel cancer therapeutics using peptide-based immunotherapy products, including our main product candidate, NeuVax™ (E75), for the treatment of various cancers.
      In this document, “we,” “our,” “ours,” “us,” “RXi,” and the “Company” refer to RXi Pharmaceuticals Corporation and Apthera, Inc., its wholly owned subsidiary. The Company has not generated any revenues since inception nor are any revenues expected for the foreseeable future. The Company expects to incur significant operating losses for the foreseeable future while the Company advances its future product candidates from discovery through pre-clinical studies and clinical trials and seek regulatory approval and potential commercialization, even if the Company is collaborating with pharmaceutical and larger biotechnology companies. In addition to these increasing research and development expenses, the Company expects general and administrative costs to increase as the Company recruits additional management and administrative personnel. The Company will need to generate significant revenues to achieve profitability and may never do so.
     The Company believes that its existing cash and cash equivalents should be sufficient to fund its operations through at least the second quarter of 2012. In the future, the Company will be dependent on obtaining funding from third parties such as proceeds from the sale of equity, funded research and development payments and payments under partnership and collaborative agreements, in order to maintain its operations and meet its obligations to licensors. There is no guarantee that debt, additional equity or other funding will be available to the Company on acceptable terms, or at all. If the Company fails to obtain additional funding when needed, it would be forced to scale back, or terminate, the Company’s operations or to seek to merge with or to be acquired by another company.
     The accompanying condensed financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) and should be read in conjunction with the Company’s financial statements and the notes thereto for the year ended December 31, 2010 included in the Company’s Annual Report on Form 10-K filed with the SEC on April 15, 2011. Certain information and footnote disclosures normally included in financial statements prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) have been condensed or omitted pursuant to such rules and regulations. The information presented as of and for the six month periods ended June 30, 2011 and 2010 and three months ended June 30, 2011 and 2010, as well as the cumulative financial information for the period from January 1, 2003 (date of inception) through June 30, 2011 is unaudited and has been prepared on the same basis as the audited financial statements and includes all adjustments, consisting of only normal recurring adjustments, necessary for the fair presentation of this information in all material respects. The results of any interim period are not necessarily indicative of the results of operations to be expected for a full fiscal year. There have been no material changes to the Company’s significant accounting policies as disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2010. The Company’s operating results will fluctuate for the foreseeable future. Therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods.
Uses of estimates in preparation of financial statements
     The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates.
Derivative Financial Instruments
     During the normal course of business, from time to time, the Company issues warrants and options to vendors as consideration to perform services. It may also issue warrants as part of a debt or equity financing. The Company does not enter into any derivative contracts for speculative purposes. The Company recognizes all derivatives as assets or liabilities measured at fair value with changes in fair value of derivatives reflected as current period income or loss unless the derivatives qualify for hedge accounting and are accounted for as such. In accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 815-40,

7


Table of Contents

RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Derivatives and Hedging — Contracts in Entity’s Own Stock ”, the value of these warrants is required to be recorded as a liability, as the holders have an option to put the warrants back to the Company in certain events, as defined.
Obligations to Repurchase Shares of the Company’s Equity Securities
     In accordance with FASB ASC Topic 480-10, “Distinguishing Liabilities from Equity” , the Company recognizes all obligations to repurchase shares of its equity securities that require or may require the Company to settle the obligation by transferring assets, as liabilities or assets in some circumstances measured at fair value with changes in fair value reflected as current period income or loss and are accounted for as such.
Deferred Revenue
     Deferred revenue consists of advance payments received under government grants. The Company will recognize revenue when the obligations under the grants are fullfilled.
2. Apthera Acquisition
     On April 13, 2011, the Company completed its acquisition of Apthera, Inc., a Delaware corporation (“Apthera”) under an Agreement and Plan of Merger entered into on March 31, 2011. Subject to the terms and conditions of the merger agreement, the Company’s wholly owned subsidiary formed for this purpose was merged with and into Apthera, with Apthera surviving as a wholly-owned subsidiary of the Company. Under the merger agreement, the Company issued to Apthera’s stockholders approximately 5.0 million shares of common stock of the Company and agreed to make future contingent payments of up to $32 million based on the achievement of certain development and commercial milestones relating to the Company’s NeuVax product candidate. The contingent consideration is payable, at the election of the Company, in either cash or additional shares of common stock, provided that the Company may not issue any shares in satisfaction of any contingent consideration unless it has first obtained approval of its stockholders in accordance with Rule 5635(a) of the NASDAQ Marketplace Rules.
     In connection with the merger, the Company deposited with a third-party escrow agent certificates representing 10% of the Aggregate Stock Consideration, which shares will be available to compensate the Company and related parties for certain indemnifiable losses as described in the merger agreement.
     The Company’s acquisition of Apthera was in concert with the decision by the Company’s Board of Directors to diversify its development programs and to become a late stage clinical development company. The Company believes that acquiring Apthera will enhance its long-term prospects by giving the Company access to a late stage product candidate, NeuVax, which is expected to enter a Phase 3 clinical trial under an FDA-approved Special Protocol Assessment (“SPA”) for the adjuvant treatment of early stage HER2 breast cancer in the first half of 2012. To do so, the Company must satisfy certain FDA information requirements to be released from a partial clinical hold to commence the Phase 3 trial. Based on Apthera’s prior clinical trials, the Company also believes that NeuVax has the potential to treat other cancers, including prostate, bladder and ovarian cancers. With the Company’s increasing focus on its cancer product candidates, the Company is assessing its strategic options with respect to its RNAi therapeutics technology platform.
The purchase price consideration and allocation of purchase price was as follows:
         
    (in 000’s)  
Calculation of allocable purchase price(i):
       
Fair value of shares issued at closing including escrowed shares expected to be released
  $ 6,367 (ii)
Estimated value of earn-out
    6,460  
 
     
Total allocable purchase price
  $ 12,827  
 
     
 
       
Estimated allocation of purchase price(i):
       
Cash
  $ 168  
Prepaid expenses and other current assets
    14  
Equipment and furnishings
    11  
Goodwill
    845  
In-process research and development
    12,864  
Accounts payable
    (931 )
Accrued expenses and other current liabilities
    (143 )
Notes payable
    (1 )
 
     
 
  $ 12,827  
 
     
 
(i)   The purchase price allocation has not been finalized and is subject to change upon completion of the valuation of intangible assets.
 
(ii)   The value of the Company’s common stock was based upon a per share value of $1.28, the closing price of the Company’s common

8


Table of Contents

     stock as of the close of business on April 13, 2011.
The following presents the pro forma net loss and net loss per common share for the three and six months ended June 30, 2011 and 2010 of the Company’s acquisition of Apthera assuming the acquisition occurred as of January 1, 2010:
                 
    For the Three Months Ended June 30,  
    2011     2010  
Net loss
  $ (1,824 )   $ (2,677 )
 
           
 
               
Net loss per common share
  $ (0.05 )   $ (0.11 )
 
           
Weighted average shares outstanding
    39,224,425       23,345,898  
 
           
                 
    For the Six Months Ended June 30,  
    2011     2010  
Net loss
  $ (6,221 )   $ (7,104 )
 
           
 
               
Net loss per common share
  $ (0.19 )   $ (0.32 )
 
           
Weighted average shares outstanding
    32,295,834       22,358,696  
 
           
3. Fair Value Measurements
     Effective January 1, 2008, the Company implemented FASB ASC Topic 820, “Fair Value Measurements and Disclosures” (“ASC 820”) for the Company’s financial assets and liabilities that are re-measured and reported at fair value at each reporting period, and are re-measured and reported at fair value at least annually using a fair value hierarchy that is broken down into three levels. Level inputs are as defined as follows:
Level 1 — quoted prices in active markets for identical assets or liabilities.
Level 2 — other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date.
Level 3 — significant unobservable inputs that reflect management’s best estimate of what market participants would use to price the assets or liabilities at the measurement date.
     The Company categorized its cash equivalents as a Level 1 hierarchy. The valuation for Level 1 was determined based on a “market approach” using quoted prices in active markets for identical assets. Valuations of these assets do not require a significant degree of judgment. The Company categorized its warrants potentially settled in cash and its common stock potentially redeemable in cash as a Level 2 hierarchy. The warrants are measured at market value on a recurring basis and are being marked to market each quarter-end until they are completely settled. The warrants are valued using the Black-Scholes method, using assumptions consistent with our application of ASC 718.
     On March 30, 2011, the Company entered into a severance agreement with its former President and Chief Executive Officer whereby, among other things, it agreed to issue shares to the former officer such that the number of shares issued times the market price of the shares on the day immediately following the separation date equal a value of $300,000. The agreement further provides that the Company will, at its option, provide a cash payment or additional shares to the former officer if necessary such that the value of 1/3 of the shares issued and 2/3 of the shares issued, respectively, at the separation date equal a guaranteed value of $100,000 as of the 90 th day following the seperation date and $200,000 as of the 180 th day following the seperation date based on the closing price of the Company’s common stock for the five days preceding each measurement date. At June 30, 2011, a liability of $200,000 was included in accrued expenses representing the guaranteed value under the severance agreement for the remaining 2/3 shares issued.

9


Table of Contents

                                 
    Quoted Prices     Significant              
    in     Other     Observable     Unobservable  
    June 30,     Active Markets     Inputs     Inputs  
Description   2011     (Level 1)     (Level 2)     (Level 3)  
Assets:
                               
Cash equivalents
  $ 17,933     $ 17,933     $     $  
                         
 
                               
Total assets
  $ 17,933     $ 17,933     $     $  
                         
 
                               
Liabilities:
                               
Stock options potentially settleable in cash
  $ 682     $     $ 682     $  
Warrants potentially settleable in cash
    11,882             11,882        
Common stock potentially settleable in cash (included in accrued expenses)
    200             200        
Contingent purchase price consideration
    6,432                   6,432  
                         
 
                               
Total liabilities
  $ 19,196     $     $ 12,764     $ 6,432  
                         
 
                               
                                 
            Quoted Prices     Significant        
            in     Other        
            Active     Observable     Unobservable  
    December 31,     Markets     Inputs     Inputs  
Description   2010     (Level 1)     (Level 2)     (Level 3)  
Assets:
                               
Cash equivalents
  $ 6,891     $ 6,891     $     $  
                         
 
                               
Total assets
  $ 6,891     $ 6,891     $     $  
                         
 
                               
Liabilities:
                               
Warrants potentially settleable in cash
  $ 3,138     $     $ 3,138     $  
                         
 
                               
Total liabilities
  $ 3,138     $     $ 3,138     $  
                         
Fair Value of Financial Instruments
     The carrying amounts reported in the balance sheet for cash equivalents, accounts payable, and capital leases approximate their fair values due to their short-term nature and market rates of interest.

10


Table of Contents

RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
4. Stock Based Compensation
     The Company follows the provisions of the FASB ASC Topic 718, “ Compensation — Stock Compensation ” (“ASC 718”), which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees, non-employee directors, and consultants, including employee stock options. Stock compensation expense based on the grant date fair value estimated in accordance with the provisions of ASC 718 is recognized as an expense over the requisite service period.
     For stock options granted as consideration for services rendered by non-employees, the Company recognizes compensation expense in accordance with the requirements of FASB ASC Topic 505-50, “ Equity Based Payments to Non- Employees.”
     Non-employee option grants that do not vest immediately upon grant are recorded as an expense over the vesting period of the underlying stock options. At the end of each financial reporting period prior to vesting, the value of these options, as calculated using the Black-Scholes option-pricing model, will be re-measured using the fair value of the Company’s common stock and the non-cash compensation recognized during the period will be adjusted accordingly. Since the fair market value of options granted to non-employees is subject to change in the future, the amount of the future compensation expense will include fair value re-measurements until the stock options are fully vested.
     The Company is currently using the Black-Scholes option-pricing model to determine the fair value of all its option grants. For option grants issued in the three and six months periods ended June 30, 2011 and 2010, the following assumptions were used:
                                 
    For the Three Months Ended June 30,     For the Six Months Ended June 30,  
    2011     2010     2011     2010  
Weighted average risk-free interest rate
    2.53 %     3.21 %     2.35 %     3.06 %
Weighted average expected volatility
    99.18 %     124.03 %     111.78 %     120.84 %
Weighted average expected lives (years)
    6.00       9.29       5.78       7.26  
Weighted average expected dividend yield
    0.00 %     0.00 %     0.00 %     0.00 %
The weighted average fair value of options granted during the six month period ended June 30, 2011 and 2010 was $1.18 and $4.34 per share, respectively.
The weighted average fair value of options granted during the three month period ended June 30, 2011 and 2010 was $1.01 and $4.87 per share, respectively.
     RXi’s expected common stock price volatility assumption is based upon the volatility of a basket of comparable companies. The expected life assumptions for employee grants were based upon the simplified method provided for under ASC 718-10. The expected life assumptions for non-employees were based upon the contractual term of the option. The dividend yield assumption of zero is based upon the fact that RXi has never paid cash dividends and presently has no intention of paying cash dividends. The risk-free interest rate used for each grant was also based upon prevailing short-term interest rates. RXi has estimated an annualized forfeiture rate of 15.0% for options granted to its employees, 8.0% for options granted to senior management and no forfeiture rate for the directors. RXi will record additional expense if the actual forfeitures are lower than estimated and will record a recovery of prior expense if the actual forfeiture rates are higher than estimated.

11


Table of Contents

     The following table summarizes stock option activity from January 1, 2011 through June 30, 2011:
                         
            Weighted        
            Average     Aggregate  
    Total Number     Exercise     Intrinsic  
    of Shares     Price     Value  
     
Outstanding at January 1, 2011
    4,333,136     $ 5.10     $ 137,000  
Granted
    2,002,500       1.42        
Exercised
                 
Cancelled
    730,947       3.65        
 
                 
 
                       
Outstanding at June 30, 2011
    5,604,689     $ 3.75     $  
 
                 
 
                       
Options exercisable at June 30, 2011
    3,949,672     $ 4.43     $  
 
                 
     The aggregate intrinsic values of outstanding and exercisable options at June 30, 2011 were calculated based on the closing price of the Company’s common stock on June 30, 2011 of $0.98 per share less the exercise price of those shares. The aggregate intrinsic values of options exercised was calculated based on the difference, if any, between the exercise price of the underlying awards and the quoted price of the Company’s common stock on the date of exercise.
5. Net Loss Per Share
     The Company accounts for and discloses net loss per common share in accordance with FASB ASC Topic 260 “ Earnings per Share.” Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares that would have been outstanding during the period assuming the issuance of common shares for all potential dilutive common shares outstanding. Potential common shares consist of shares issuable upon the exercise of stock options and warrants. Because the inclusion of potential common shares would be anti-dilutive for all periods presented, diluted net loss per common share is the same as basic net loss per common share.
     The following table sets forth the potential common shares excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive:
                 
    June 30,  
    2011     2010  
     
Options to purchase common stock
    5,604,689       4,326,963  
Warrants to purchase common stock
    20,200,642       2,100,642  
 
           
Total
    25,805,331       6,427,605  
 
           
6. License Agreements
     As part of its business, the Company enters into licensing agreements, which often require milestone and royalty payments based on the progress of the asset through development stages. Milestone payments may be required, for example, upon approval of the product for marketing by a regulatory agency. In certain agreements, RXi is required to make royalty payments based upon a percentage of product sales.
     An individual milestone payment required under the licensing arrangements may be material, and in the event that multiple milestones are reached in the same period, the aggregate payments associated with the milestones could adversely affect the results of operations or affect the comparability of our period-to-period results. In addition, these licensing arrangements often give the Company the discretion to unilaterally terminate development of the product, which would allow the Company to avoid making the contingent payments; however, the Company is unlikely to cease development if the compound successfully achieves clinical testing objectives. During the quarter, the Company cancelled several of its licenses with the University of Massachusetts Medical School (“UMMS”). Additionally, in conjunction with the acquisition of Apthera, the Company assumed the rights and obligations of a certain license agreement, as amended, from The University of Texas M. D. Anderson Cancer Center (“MDACC”) and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (“HJF”) which grants exclusive worldwide rights to the use of one patent and one patent application involving the use of the E75 peptide. Under the terms of this license, we are required to make future annual maintenance fee payments, as well as clinical milestone payments and royalty payments based on sales of therapeutic products developed from the licensed technologies. As part of the expected payments under the terms of the license, the Company must pay an annual maintenance fee of $175,000 in 2011 and $200,000 in 2012. In addition, upon commencing the Phase 3 trial, we will pay a milestone payment of $200,000.
7. Equity
2011 Financings
     On April 20, 2011, the Company completed an underwritten public offering of 11,950,000 units at a price to the public of $1.00 per unit for gross proceeds of approximately $12 million (the “April 2011 Offering”). Each unit consisted of one share of common stock and a warrant to purchase one share of common stock at an exercise price of $1.00 per share. The shares of common stock and warrants were immediately separable and no separate units were issued. The warrants are exercisable beginning one year and one day from the date of issuance, but only if the Company’s stockholders approve an increase in the number of authorized shares of common stock of the Company, and expire on the sixth

12


Table of Contents

anniversary of the date of issuance. Net proceeds, after underwriting discounts and commissions and other offering expenses, were approximately $10.9 million. In connection with the April financing, the Company agreed to hold a stockholders meeting no later than July 31, 2011 in order to seek stockholder approval for an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the authorized number of shares or our common stock. The Board of Directors of the Company subsequently adopted an amendment to increase the authorized shares of common stock to 125,000,000, which was presented to and approved by the stockholders of the Company at the 2011 Annual Meeting of Stockholders held on July 15, 2011.
     On March 4, 2011, the Company closed an underwritten public offering of 6,000,000 units at a price to the public of $1.35 per unit for gross proceeds of $8.1 million (the“March 2011 Offering”). The offering provided approximately $7.3 million to the Company after deducting the underwriting discounts and commissions and offering expenses. Each unit consists of (i) one share of common stock, (ii) a thirteen-month warrant to purchase 0.50 of a share of common stock at an exercise price of $1.70 per share (subject to anti-dilution adjustment) and (iii) a five-year warrant to purchase 0.50 of a share of common stock at an exercise price of $1.87 per share (subject to anti-dilution adjustment). On April 15, 2011, the holders of outstanding warrants issued in the March 2011 Offering to purchase an aggregate of 3,450,000 shares of common stock agreed to exchange such warrants for warrants exercisable for the same number of shares as those being exchanged, but otherwise on the same terms of the warrants sold in the Company’s April 2011 financing. Prior to the exchange, the Company recorded a decrease in fair value of $1,000,000 related to the exchanged warrants. Upon the exchange, the Company recorded a loss of $900,000, which represented the difference between the adjusted fair value of the March 2011 warrants as compared to the fair value of the April 2011 warrants received in the exchange. As a result of a subsequent offering that was completed on April 15, 2011, the exercise price of the remaining 2,550,000 outstanding warrants sold in the March 2011 Offering was reduced to $1.00 per share as a result of the anti-dilution adjustment.
Warrants Potentially Settleable in Cash
     Certain warrants issued in connection with a registered direct stock offering on August 3, 2009 (the “2009 Offering”) were determined not to be indexed to the Company’s common stock as they are potentially settleable in cash. The fair value of the warrants at the dates of issuance totaling $2,863,000 was recorded as a liability and a cost of equity and was determined by the Black-Scholes option pricing model. Due to the fact that the Company has limited trading history, the Company’s expected stock volatility assumption is based on a combination of implied volatilities of similar entities whose shares or options are publicly traded. The Company used a weighted average expected stock volatility of 122.69%. The expected life assumption is based on the contract term of five years. The dividend yield of zero is based on the fact that the Company has no present intention to pay cash dividends. The risk free rate of 1.72% used for the warrants is equal to the zero coupon rate in effect at the time of the grant. The decrease in the fair value of the warrants from the date of issuance to June 30, 2011 is $2,718,000, of which $1,799,000 has been included in other income and expense in the accompanying condensed statements of expenses for the six months ended June 30, 2011. The fair value of the warrants at June 30, 2011 of $144,000 is included as a current liability in the accompanying balance sheets and was determined by the Black-Scholes option pricing model. Due to the fact that the Company has limited trading history, the Company’s expected stock volatility assumption is based on a combination of implied volatilities of similar entities whose shares or options are publicly traded. The Company used a weighted average expected stock volatility of 74.52%. The expected life assumption is based on the remaining contract term of 3.1 years. The dividend yield of zero is based on the fact that we have no present intention to pay cash dividends. The risk free rate of 0.81% used for the warrants is equal to the zero coupon rate in effect on the date of the re-measurement.
     Certain warrants issued in connection with the March 22, 2010 stock offering (the “2010 Offering”) were determined not to be indexed to the Company’s common stock as they are potentially settleable in cash. The fair value of the warrants at the dates of issuance totaling $2,466,000 was recorded as a liability and a cost of equity and was determined using the Black-Scholes option pricing model. Due to the fact that the Company has limited trading history, our expected stock volatility assumption is based on a combination of implied volatilities of similar entities whose shares or options are publicly traded. The Company used a weighted average expected stock volatility of 119.49%. The expected life assumption is based on the contract term of 6.5 years. The dividend yield of zero is based on the fact that we have no present intention to pay cash dividends. The risk free rate of 3.22% used for the warrants is equal to the zero coupon rate in effect at the time of the grant. The decrease in the fair value of the warrants from date of issuance to June 30, 2011 is $2,245,000, of which $974,000 has been included in other income and expense in the accompanying condensed statements of expenses for the six months ended June 30, 2011. The fair value of the warrants at June 30, 2011 of $221,000 is included as a current liability in the accompanying balance sheets and was determined by the Black-Scholes option pricing model. Due to the fact that the Company has limited trading history, the Company’s expected stock volatility assumption is based on a combination of implied volatilities of similar entities whose shares or options are publicly traded. The Company used a weighted average expected stock volatility of 74.52%. The expected life assumption is based on the remaining contract term of 5.25 years. The dividend yield of zero is based on the fact that the Company has no present intention to pay cash dividends. The risk free rate of 1.76% used for the warrants is equal to the zero coupon rate in effect on the date of the re-measurement.
     The thirteen-month and five-year warrants issued in connection with the March 2011 Offering were determined not to be indexed to the Company’s common stock as they are potentially settleable in cash. The fair value of the remaining 2,550,000 warrants at the date of issuance totaling $1,790,000 was recorded as a liability and a cost of equity and was determined using the Black-Scholes option pricing model. Due to the fact that the Company has limited trading history, the Company expected stock volatility assumption is based on a combination of implied volatilities of similar entities whose shares or options are publicly traded. The Company used a weighted average expected stock volatility of 113.25%. The expected life assumption is based on the contract term of 1.08 years used for the thirteen-month warrants and 5 years used for the five-year warrants. The dividend yield of zero is based on the fact that we have no present intention to pay cash dividends. The risk free rate of 0.26% used for the thirteen-month warrants and 2.17% used for the five-year warrants is

13


Table of Contents

equal to the zero coupon rate in effect at the time of the grant. The decrease in the fair value of the warrants from date of issuance to June 30, 2011 of $745,000 has been included in other income and expense in the accompanying condensed statements of expenses for the six months ended June 30, 2011. The fair value of the warrants at June 30, 2011 of $1,050,000 is included as a current liability in the accompanying balance sheets and was determined using the Black-Scholes option pricing model. Due to the fact that the Company has limited trading history, the Company’s expected stock volatility assumption is based on a combination of implied volatilities of similar entities whose shares or options are publicly traded. The Company used a weighted average expected stock volatility of 74.52%. The expected life assumption is based on the remaining contract term of one year used for the thirteen-month warrants and 4.7 years used for the five- year warrants. The dividend yield of zero is based on the fact that the Company has no present intention to pay cash dividends. The risk free rate of 0.19% used for the thirteen-month warrants and 1.76% used for the five-year warrants is equal to the zero coupon rate in effect on the date of the re-measurement.
     The warrants issued in connection with the April 2011 Offering, including the warrants issued in exchanged for the March 2011 warrants, were determined not to be indexed to the Company’s common stock as they are potentially settleable in cash. The fair value of the warrants at the dates of issuance totaling $11,442,000 was recorded as a liability and a cost of equity and was determined using the Black-Scholes option pricing model. Due to the fact that the Company has limited trading history, the Company’s expected stock volatility assumption is based on a combination of implied volatilities of similar entities whose shares or options are publicly traded. The Company used a weighted average expected stock volatility of 99.04%. The expected life assumption is based on the contract term of 7.0 years. The dividend yield of zero is based on the fact that we have no present intention to pay cash dividends. The risk free rate of 2.81% used for the warrants is equal to the zero coupon rate in effect at the time of the grant. The decrease in the fair value of the warrants from date of issuance to June 30, 2011 is $1,875,000, of which all has been included in other income and expense in the accompanying condensed statements of expenses for the six months ended June 30, 2011. The fair value of the warrants at June 30, 2011 of $10,467,000 is included as a current liability in the accompanying balance sheets and was determined by the Black-Scholes option pricing model. Due to the fact that the Company has limited trading history, the Company’s expected stock volatility assumption is based on a combination of implied volatilities of similar entities whose shares or options are publicly traded. The Company used a weighted average expected stock volatility of 74.52%. The expected life assumption is based on the remaining contract term of 6.8 years. The dividend yield of zero is based on the fact that the Company has no present intention to pay cash dividends. The risk free rate of 2.5% used for the warrants is equal to the zero coupon rate in effect on the date of the re-measurement. Additionally, in connection with the previously discussed exchange, the Company recorded a loss of approximately $900,000 which accounts for the remaining change in value during the period.
Stock Options Modified
     On April 14, 2011, all of the Company’s directors and certain of the Company’s executive officers executed agreements with the Company under which they agreed that none of their outstanding stock options will be exercisable unless and until the Company increases the number of authorized shares of common stock to a number that is sufficient to permit the exercise or conversion in full of all then outstanding options of the Company (including their stock options), warrants and other securities of the Company that are convertible into shares of common stock. An aggregate of 3,489,256 option shares are covered by these agreements. For accounting purposes, the agreement of all of the Company’s directors and certain executive officers to place restrictions of the exercisability of their options is treated as a modification of their options resulting in the reclassification of the options from equity to a liability. In connection with the modification, the Company will recognize compensation cost equal to the greater of (a) the grant date fair value of the original equity award plus an incremental cost associated with the modification or (b) the fair value of the modified award when it is settled. As of June 30, 2011, the Company recorded a liability of $682,000 representing the fair value of the vested portion of these options with a corresponding decrease of $674,000 to additional paid in capital for previously recognized stock compensation expense and a $7,000 charge to operations.

14


Table of Contents

RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
8. Recent Accounting Pronouncements
     Effective January 1, 2010, the Company adopted Accounting Standards Update (ASU) No. 2010-06, Fair Value Measurements and Disclosures (Topic 820): Improving Disclosures about Fair Value Measurements , or ASU 2010-06. A reporting entity should provide additional disclosures about the different classes of assets and liabilities measured at fair value, the valuation techniques and inputs used, the activity in Level 3 fair value measurements, and the transfers between Levels 1, 2, and 3 fair value measurements. The adoption of the additional disclosures for Level 1 and Level 2 fair value measurements did not have an impact on the Company’s financial position, results of operations or cash flows. The disclosures regarding Level 3 fair value measurements were adopted by the Company January 1, 2011 and did not have an impact on the Company’s financial position, results of operations or cash flows or require additional disclosures.
     Effective January 1, 2010, the Company adopted ASU No. 2009-17, Consolidations (Topic 810): Improvements to Financial Reporting by Enterprises Involved with Variable Interest Entities, or ASU 2009-17. The amendments in this update replace the quantitative-based risks and rewards calculation for determining which reporting entity, if any, has a controlling financial interest in a variable interest entity with an approach focused on identifying which reporting entity has the power to direct the activities of a variable interest entity that most significantly impact the entity’s economic performance and (1) the obligation to absorb losses of the entity or (2) the right to receive benefits from the entity. An approach that is expected to be primarily qualitative will be more effective for identifying which reporting entity has a controlling financial interest in a variable interest entity. The amendments in this update also require additional disclosures about a reporting entity’s involvement in variable interest entities, which will enhance the information provided to users of financial statements. The Company evaluated its business relationships to identify potential variable interest entities and has concluded that consolidation of such entities is not required for the periods presented. On a quarterly basis, the Company will continue to has reassess its involvement with variable interest entities.
     In December 2010, the FASB issued ASU No. 2010-28, Intangibles — Goodwill and Other (Topic 350): “When to Perform Step 2 of the Goodwill Impairment Test for Reporting Units with Zero or Negative Carrying Amounts . ASU 2010-28 is effective for fiscal years beginning after December 15, 2010 and amends the criteria for performing Step 2 of the goodwill impairment test for reporting units with zero or negative carrying amounts and requires performing Step 2 if qualitative factors indicate that it is more likely than not that a goodwill impairment exists. We do not believe that this will have a material impact on our consolidated financial statements.
     In December 2010, the FASB issued ASC Update 2010-29, Business Combinations (Topic 805) - Disclosure of Supplementary Pro Forma Information for Business Combinations (Update No. 2010-29). This Update requires a public entity to disclose pro forma information for business combinations that occurred in the current reporting period. The disclosures include pro forma revenue and earnings of the combined entity for the current reporting period as though the acquisition date for all business combinations that occurred during the year had been as of the beginning of the annual reporting period. If comparative financial statements are presented, the pro forma revenue and earnings of the combined entity for the comparable prior reporting period should be reported as though the acquisition date for all business combinations that occurred during the current year had been as of the beginning of the comparable prior annual reporting period. This Update affects any public entity that enters into business combinations that are material on an individual or aggregate basis and is effective prospectively for business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2010. The Company adopted updated No. 2010-29 beginning January 1, 2011. The financial statements have been updated to reflect the adoption of this pronouncement.
     In May 2011, the Financial Accounting Standards Board (“FASB”) issued a new accounting standard that clarifies the application of certain existing fair value measurement guidance and expands the disclosures for fair value measurements that are estimated using significant unobservable (Level 3) inputs. This new standard is effective on a prospective basis for annual and interim reporting periods beginning on or after December 15, 2011. The Company does not expect that adoption of this new standard will have a material impact on its condensed consolidated financial statements.
     In June 2011, the FASB issued a new accounting standard that eliminates the option to present the components of other comprehensive income as part of the statement of changes in stockholders’ equity, requires the consecutive presentation of the statement of net income and other comprehensive income and requires an entity to present reclassification adjustments on the face of the financial statements from other comprehensive income to net income. The amendments in this new standard do not change the items that must be reported in other comprehensive income or when an item of other comprehensive income must be reclassified to net income nor do the amendments affect how earnings per share is calculated or presented. This new standard is required to be applied retrospectively and is effective for fiscal years and interim periods within those years beginning after December 15, 2011. As this new standard only requires enhanced disclosure, the adoption of this standard will not impact the Company’s condensed consolidated financial statements.

15


Table of Contents

RXi PHARMACEUTICALS CORPORATION
(A Development Stage Company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
9. Subsequent Events
     The Company evaluated all events or transactions that occurred after June 30, 2011 up through the date these financial statements were issued. Other than what is disclosed below, during this period, the Company did not have any material recognizable or unrecognizable subsequent events.
     On April 21, 2011, the Company’s Board of Directors authorized an increase in the Company’s authorized shares of common stock to 125,000,000 shares, subject to approval of the Company’s stockholders. On July 15, 2011, the Company’s stockholders approved the amendment.
     On April 21, 2011, our Board of Directors adopted an amendment to the 2007 Incentive Plan that would increase the maximum number of shares of common stock authorized for issuance under the 2007 Incentive Plan by 2,000,000 shares to a total of 8,750,000 shares. On July 15, 2011, the Company’s stockholders approved the amendment.

16


Table of Contents

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
      In this document, “we,” “our,” “ours,” “us,” “RXi” and the “Company” refer to RXi Pharmaceuticals Corporation and Apthera, Inc., its wholly owned subsidiary.
      This management’s discussion and analysis of financial condition as of June 30, 2011 and results of operations for the three months and six months ended June 30, 2011 and 2010 should be read in conjunction with management’s discussion and analysis of financial condition and results of operations included in our Annual Report on Form 10-K for the year ended December 31, 2010 which was filed with the SEC on April 15, 2011.
      The discussion and analysis below includes certain forward-looking statements related to future operating losses and our potential for profitability, the sufficiency of our cash resources, our ability to obtain additional equity or debt financing, possible partnering or other strategic opportunities for the development of our products, as well as other statements related to the progress and timing of product development, present or future licensing, collaborative or financing arrangements or that otherwise relate to future periods, which are all forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. These statements represent, among other things, the expectations, beliefs, plans and objectives of management and/or assumptions underlying or judgments concerning the future financial performance and other matters discussed in this document. The words “may,” “will,” “should,” “plan,” “believe,” “estimate,” “intend,” “anticipate,” “project,” and “expect” and similar expressions are intended to identify forward-looking statements. All forward-looking statements involve certain risks, uncertainties and other factors described elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2010, that could cause our actual results of operations, performance, financial position and business prospects and opportunities for this quarter and the periods that follow to differ materially from those expressed in, or implied by, those forward-looking statements. We caution investors not to place significant reliance on the forward-looking statements contained in this report. These statements, like all statements in this report, speak only as of the date of this report (unless another date is indicated) and we undertake no obligation to update or revise forward-looking statements.
Overview
     RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics. RXi is pursuing the development of novel cancer therapeutics using peptide-based immunotherapy products, including our main product candidate, NeuVax™ (E75), for the treatment of various cancers.
Results of Operations
For the Three and Six Months Ended June 30, 2011 and June 30, 2010
     We reported a loss from operations of $4,622,000, which includes $506,000 of non-cash equity based compensation, for the three months ended June 30, 2011 compared with a loss from operations of $4,754,000, which includes $1,616,000 of non-cash equity compensation, in 2010. The decrease in loss of $132,000, or 3%, was due primarily to a $1,110,000 decrease in non-cash equity compensation and a $44,000 decrease in general and administrative expenses offset by an increase of $1,022,000 in research and development expenses, as noted below.
     We reported a loss from operations of $9,901,000, which includes $1,919,000 of non-cash equity based compensation, for the six months ended June 30, 2011 compared with a loss from operations of $9,210,000, which includes $3,125,000 of non-cash equity based compensation, in 2010. The increase in loss of $691,000, or 8%, was due primarily to a $1,206,000 decrease in non-cash equity compensation offset by a $1,468,000 increase in research and development expenses and an increase of $429,000 in general and administrative expenses, as noted below.
     For the three months ended June 30, 2011, our net loss was approximately $1,382,000 compared with a net loss of $2,141,000 for the three months ended June 30, 2010. The decrease in net loss of $759,000 or 35% includes the loss from operations of $4,622,000 and $3,243,000 in non-cash other income related to the change in fair value of common stock warrants issued in several financing transactions. The result was a net loss per share of $0.04 and $0.12 for the three months ended June 30, 2011 and 2010, respectively. Variations in the losses between the two periods are discussed below.
      For the six months ended June 30, 2011, our net loss was approximately $5,227,000 compared with a net loss of $6,027,000 for the six months ended June 30, 2010. The decrease in net loss of $800,000, or 13%, includes the loss from operations of $9,901,000 offset by other income of $4,678,000 related to the change in fair value of warrants issued in several financing transactions and government grant monies received. The result was a net loss per share of $0.18 and $0.35 for the six months ended June 30, 2011 and 2010, respectively. Variations in the losses between the two periods are discussed below.

17


Table of Contents

Research and Development Expense
     Research and development expense consists primarily of compensation-related costs for our employees dedicated to research and development activities and for our Scientific Advisory Board (“SAB”) members, as well as licensing fees, patent prosecution costs, and the cost of lab supplies used in our research and development programs. We expect research and development expenses to increase as we expand our discovery and development activities.
     Total research and development expenses were approximately $2,673,000 for the three months ended June 30, 2011, compared with $2,264,000 for the three months ended June 30, 2010. The increase of $409,000, or 18%, was primarily due to an increase of $1,022,000 in research and development cash expenses due to a ramp up in NeuVax-related consulting fees and activities in our progression toward releasing NeuVax off clinical hold offset by a decrease of $558,000 in non-employee non-cash stock based compensation related to a change in our Black-Scholes assumptions and $55,000 in employee non-cash stock based compensation.
     Total research and development expenses were approximately $4,833,000 for the six months ended June 30, 2011, compared with $4,190,000 for the six months ended June 30, 2010. The increase of $643,000, or 15%, was primarily due to an increase of $1,468,000 in research and development cash expenses due to a ramp up in NeuVax-related consulting fees and activities in our progression toward releasing NeuVax off clinical hold, which was partially offset by a decrease of $743,000 in non-employee non-cash stock based compensation and a $82,000 decrease in employee non-cash stock based compensation.
General and Administrative Expense
     General and administrative expenses include compensation-related costs for our employees dedicated to general and administrative activities, legal fees, audit and tax fees, consultants and professional services, and general corporate expenses.
     General and administrative expenses were approximately $1,949,000 for the three months ended June 30, 2011, compared with $2,490,000 for the three months ended June 30, 2010. The decrease of $541,000, or 22%, was primarily due to a $318,000 decrease in non-cash employee stock based compensation and a $179,000 decrease due to non-cash stock based compensation expense related to a change in our Black-Scholes assumptions. Excluding these non-cash items, general and administrative expenses were approximately $1,610,000 for the three months ended June 30, 2011, compared with $1,654,000 for the three months ended June 30, 2010. The decrease of $44,000 was primarily due to a decrease in headcount offset by severance payments in connection with a reduction in force.
     General and administrative expenses were approximately $5,068,000 for the six months ended June 30, 2011, compared with $5,020,000 for the six months ended June 30, 2010. The increase of $48,000, or 1%, was primarily due to a $413,000 decrease in non-cash stock based compensation related to a warrant issued for business advisory services offset by a $9,000 increase in employee non-cash stock based compensation and a $23,000 increase due to non-cash stock based compensation expense. Excluding these non-cash items, general and administration expense were approximately $3,531,000 for the six months ended June 30, 2011, compared with $3,102,000 for the six months ended June 30, 2010. The increase of $429,000 was primarily due to severance payments in connection with a reduction in force.
Interest Income
     Interest income was negligible for the three and six months ended June 30, 2011 and 2010. The key objectives of our investment policy are to preserve principal and ensure sufficient liquidity, so our invested cash may not earn as high a level of income as longer-term or higher risk securities, which generally have less liquidity and more volatility.
Other Income/Expense
     Other income and expense for the three months ended June 30, 2011 was approximately $3,243,000 which includes $3,057,000 in non-cash income related to a gain on the change in the fair value of common stock warrants issued in connection with several financing transactions in 2009, 2010 and 2011 and $186,000 in government grant monies received.
     Other income and expense for the six months ended June 30, 2011 was approximately $4,678,000 which includes $4,493,000 in non-cash income related to a gain on the change in the fair value of common stock warrants issued in connection with several financing transactions in 2009, 2010 and 2011 and $186,000 in government grant monies received. The fair value of the 2009, 2010 and 2011 warrants of $11,882,000 at June 30, 2011 is included as a current liability in the accompanying balance sheets and were determined using the Black-Scholes option pricing model.
Liquidity and Capital Resources
     We had cash and cash equivalents of approximately $17.9 million as of June 30, 2011, compared with $5.1 million as of June 30, 2010. We have not generated revenue to date and may not generate product revenue in the foreseeable future, if ever. We expect to incur significant operating losses as we advance our product candidates through the drug development and regulatory process. In addition to increasing research and development expenses, we expect general and administrative costs to increase as we add personnel and assume Apthera’s operations. We will need to generate significant revenues to achieve profitability and might never do so. In the absence of product revenues, our potential

18


Table of Contents

sources of operational funding are expected to be the proceeds from the sale of equity, funded research and development payments and payments received under partnership and collaborative agreements.
     As a result of our acquisition of Apthera and the expenses expected to be incurred in connection with the Phase 3 clinical trial for NeuVax, we expect that our expenses will increase significantly from historic levels for the foreseeable future. We believe that our existing cash and cash equivalents should be sufficient to fund our operations through at least the second quarter of 2012. In the future, we will be dependent on obtaining funding from third parties, such as proceeds from the sale of equity, funded research and development payments and payments under partnership and collaborative agreements, in order to maintain our operations and meet our obligations to licensors. There is no guarantee that additional equity or other funding will be available to us on acceptable terms, or at all. If we fail to obtain additional funding when needed, we would be forced to scale back, or terminate, our operations or to seek to merge with or to be acquired by another company.
Net Cash Flow from Operating Activities
     Net cash used in operating activities was approximately $7,086,000 for the six months ended June 30, 2011, compared with $6,151,000 for the six months ended June 30, 2010. The increase of approximately $935,000 resulted primarily from a net loss of $5,227,000, of which $1,810,000 related to stock-based compensation, $23,000 related to common stock issued in exchange for services, $87,000 related to stock warrant expense in exchange for services, $84,000 related to depreciation, a $7,000 loss on disposal of equipment, $900,000 related to the loss on exchange of equity instruments, and $5,393,000 that reflects the fair value of warrants and mandatorily redeemable stock obligations issued in financings completed by the Company in 2009, 2010 and 2011 and $651,000 related to changes in current assets and liabilities.
Net Cash Flow from Investing Activities
     Net cash used in investing activities was approximately $115,000 for the six months ended June 30, 2011, compared with $6,050,000 for the six months ended June 30, 2010. The increase was primarily due to $168,000 in cash received from the Apthera acquisition offset by $53,000 in purchases of equipment and furnishings in 2011 compared with $5,996,000 in the purchase of short term investments and $54,000 in purchases of equipment and furnishing for the same period in 2010.
Net Cash Flow from Financing Activities
     Net cash provided by financing activities was $18,013,000 for the six months ended June 30, 2011, compared with $11,610,000 for the six months ended June 30, 2010. The increase was primarily due to net proceeds from the issuance of common stock in the amount of $18,060,000 from the March and April 2011 financings compared with net proceeds from the issuance of common stock in the amount of $15,235,000 from the financing completed in the first half of 2010.
Off-Balance Sheet Arrangements
     We have not entered into off-balance sheet financing, other than operating leases.
Critical Accounting Policies and Estimates
     In our Annual Report on Form 10-K for the year ended December 31, 2010, we disclosed our critical accounting policies and estimates upon which our financial statements are derived. There have been no changes to these policies since December 31, 2010. Readers are encouraged to review these disclosures in conjunction with the review of this quarterly report on Form 10-Q.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
     As of the end of the period covered by this quarterly report on Form 10-Q, our Chief Executive Officer and Chief Financial Officer (the “Certifying Officers”), evaluated the effectiveness of our disclosure controls and procedures. Disclosure controls and procedures are controls and procedures designed to reasonably assure that information required to be disclosed in our reports filed under the Securities Exchange Act of 1934 (the “Exchange Act”), such as this Form 10-Q, is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms. Disclosure controls and procedures are also designed to reasonably assure that such information is accumulated and communicated to our management, including the Certifying Officers, as appropriate to allow timely decisions regarding required disclosure. Based on these evaluations, the Certifying Officers have concluded, that, as of the end of the period covered by this quarterly report on Form 10-Q:
(a)   our disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act was recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms; and
 
(b)   our disclosure controls and procedures were effective to provide reasonable assurance that material information required to be disclosed by us in the reports we file or submit under the Exchange Act was accumulated and communicated to our management, including the

19


Table of Contents

    Certifying Officers, as appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
     There has not been any change in our internal control over financial reporting that occurred during the quarterly period ended June 30, 2011 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

20


Table of Contents

RXi PHARMACEUTICALS CORPORATION
PART II — OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None
ITEM 1.A RISK FACTORS
You should consider the “Risk Factors” included under Item 1A. of our annual report on Form 10-K for the year ended December 31, 2010, filed on April 15,2011 with the SEC.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
     In connection with the completion on April 13, 2011 of our acquisition of Apthera, the Company issued to the former Apthera shareholders an aggregate of approximately 5.0 million shares of common stock of the Company. The shares were issued in a private transaction without registration under the Securities Act of 1933, as amended (the “Act”), in reliance on the exemptions from registration afforded by Section 4(2) of the Act and Regulation D under the Act.
     In connection with the completion of the April 2011 Offering, the Company issued warrants to purchase 3,450,000 shares of common stock of the Company to several institutional investors in exchange for warrants to purchase the same number of shares of our common stock that had been acquired by the investors in our March 2011 Offering. The warrants were exchanged without registration under the Act in reliance on the exemptions from registration afforded by Section 4(2) of the Act and Regulation D under the Act.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4. REMOVED AND RESERVED
ITEM 5. OTHER INFORMATION
None
ITEM 6. EXHIBITS
EXHIBIT INDEX
     
Exhibit    
Number   Description
1.1
  Underwriting Agreement dated as of April 15, 2011 by and among RXi Pharmaceuticals Corporation and ROTH Capital Partners, LLC. (1)
 
   
4.1
  Form of Common Stock Purchase Warrant issued in April 2011. (1)
 
   
4.2
  Form of Warrant Exchange Agreement entered into on April 14, 2011 by RXi Pharmaceuticals Corporation with Cranshire Capital, LP, Freestone Advantage Partners, LP, Capital Ventures International, Empery Asset Master, LTD, Hartz Capital Investments, LLC, Hudson Bay Master Fund, LTD, Rockmore Investment Master Fund, LTD, Tenor Opportunity Master Fund, LTD, Aria Opportunity Fund, LTD, Parsoon Opportunity Fund, LTD. **
 
   
10.1
  Patent and Technology License Agreement, dated September 11, 2006, by and among the Board of Regents of the University of Texas System, the University of Texas M.D. Anderson Cancer Center, the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and Advanced Peptide Therapeutics, Inc. (currently known as Apthera, Inc.). † **
 
   
10.2
  Amendment No. 1 to Patent and Technology License Agreement, dated December 21, 2007, by and among the Board of Regents of the University of Texas System, the University of Texas M.D. Anderson Cancer Center, the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and Apthera, Inc. (formerly known as Advanced Peptide Therapeutics, Inc.).**
 
   
10.3
  Amendment No. 2 to Patent and Technology License Agreement, dated September 3, 2008, by and among the Board of Regents of the University of Texas System, the University of Texas M.D. Anderson Cancer Center, the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and Apthera, Inc. (formerly known as Advanced Peptide Therapeutics, Inc.).**
 
   
10.4
  Amendment No. 3 to Patent and Technology License Agreement, dated July 8, 2009, by and among the Board of Regents of the University of Texas System, the University of Texas M.D. Anderson Cancer Center, the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and Apthera, Inc. (formerly known as Advanced Peptide Therapeutics, Inc.).**
 
   
10.5
  Amendment No. 4 to Patent and Technology License Agreement, dated February 11, 2010, by and among the Board of Regents of the University of Texas System, the University of Texas M.D. Anderson Cancer Center, the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and Apthera, Inc. (formerly known as Advanced Peptide Therapeutics, Inc.). † **
 
   
10.6
  Amendment No. 5 to Patent and Technology License Agreement, dated January 10, 2011, by and among the Board of Regents of the University of Texas System, the University of Texas M.D. Anderson Cancer Center, the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and Apthera, Inc. (formerly known as Advanced Peptide Therapeutics, Inc.). † **
 
   
10.7
  Employment Agreement between RXi Pharmaceuticals Corporation and Mark J. Ahn, Ph.D., dated March 31, 2011. * (2)
 
   
10.8
  Employment Agreement between RXi Pharmaceuticals Corporation and Mark W. Schwartz, Ph.D., dated April 13, 2011. * **
 
   
10.9
  Employment Agreement between RXi Pharmaceuticals Corporation and Robert E. Kennedy, dated April 13, 2011. * **
 
   
10.10
  Scientific Advisory Agreement between RXi Pharmaceuticals Corporation and George E. Peoples, Ph.D., dated April 13, 2011.**
 
   
10.11
  Form of Amendment to Stock Options Granted under RXi Pharmaceuticals Corporation 2007 Incentive Plan, entered into in April 2011 by RXi Pharmaceuticals Corporation with all directors of RXi Pharmaceuticals Corporation, as of April 1, 2011, and Mark J. Ahn, Ph.D., Anastasia Khvorova, Ph.D., and Pamela Pavco, Ph.D. * **
 
10.12
  Exclusive License Agreement, dated as of July 11, 2011, by and among The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., RXi Pharmaceuticals Corporation and its wholly-owned subsidiary, Apthera, Inc. † **
 
   
31.1
  Sarbanes-Oxley Act Section 302 Certification of Chief Executive Officer. **
 
   
31.2
  Sarbanes-Oxley Act Section 302 Certification of Chief Financial Officer. **
 
   
32.1
  Sarbanes-Oxley Act Section 906 Certifications of Chief Executive Officer and Chief Financial Officer. **
 
101
  The following financial information from the Quarterly Report on Form 10-Q of RXi Pharmaceuticals Corporation for the quarter ended June 30, 2011, formatted in XBRL (eXtensible Business Reporting Language): (1) Condensed Consolidated Balance Sheets as of June 30, 2011 and December 31, 2010; (2) Condensed Consolidated Statements of Expenses for the three months and six months ended June 30, 2011 and 2010 and for the period from January 1, 2003 (inception) to June 30, 2011; (3) Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2011 and 2010 and for the cumulative period from January 1, 2003 (inception) to June 30, 2011; and (4) Notes to Condensed Consolidated Financial Statements (Unaudited).***
 
  Certain portions of the Exhibit have been omitted based upon a request for confidential treatment filed by us with the Securities and Exchange Commission. The omitted portions of the Exhibit have been separately filed by us with the Securities and Exchange Commission.
 
*   Indicates a management contract or compensatory plan or arrangement.
 
**   Filed with this Quarterly Report on Form 10-Q.
 
***   In accordance with Rule 406T of Regulation S-T, the XBRL-related information in Exhibit 101 to this Quarterly Report on Form 10-Q is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 and 12 of the Securities Act, is deemed not filed for purposes of Section 18 of the Exchange Act, and otherwise is not subject to liability under these sections, is not part of any registration statement or prospectus to which it relates and is not incorporated by reference into any registration statement, prospectus or other document.
 
(1)   Previously filed as an Exhibit to the Company’s Form 8-K filed on April 15, 2011 and incorporated by reference herein.
 
(2)   Previously filed as an Exhibit to the Company’s Form 8-K filed on April 5, 2011 and incorporated by reference herein.

21


Table of Contents

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
         
  RXi PHARMACEUTICALS CORPORATION (Registrant)
 
 
  By:   /s/ Mark J. Ahn    
    Mark J. Ahn   
    President and Chief Executive Officer   
 
     
  By:   /s/ Robert E. Kennedy    
    Robert E. Kennedy   
  Vice President and Chief Financial Officer

Date: August 15, 2011 
 
 

22

Exhibit 4.2
April 14, 2011
RXi Pharmaceuticals Corporation
60 Prescott Street
Worcester, MA 01605
Attention: Mark J. Ann, President and Chief Executive Officer
     The undersigned is the record and beneficial owner of the warrants to purchase shares of common stock, par value $0.01 per share (“Common Stock”) of RXi Pharmaceuticals Corporation (the “Company”) set forth on Schedule A hereto (the “Warrants”).
     The undersigned understands that the Company intends to effect an underwritten public offering (the “Offering”) of units consisting of (i) shares of Common Stock and warrants to purchase shares of Common Stock (the “New Warrants”). The Offering is described in the Company’s preliminary prospectus supplement, dated April 14, 2011 (the “Preliminary Prospectus Supplement”), filed with the Securities and Exchange Commission (the “Commission”). The undersigned acknowledges receipt of a copy of the Preliminary Prospectus. Certain additional information relating to the terms of the Offering, including the terms of the New Warrants have been provided to the undersigned by Roth Capital Partners, LLC. The undersigned further acknowledges that it has received such additional information and has had an opportunity to ask questions of and receive answers from the Company regarding the terms of the Offering.
     In consideration of its participation in the Offering, effective as of the closing date of the Offering, the undersigned irrevocably agrees to exchange its Warrants for warrants to purchase Common Stock having the same terms as the New Warrants (the “Exchange Warrants”) and exercisable, subject to the terms of the Exchange Warrants, for the same aggregate number of shares of Common Stock as the Warrants are currently exercisable (the “Exchange”). Not later than the Closing Date, the undersigned shall deliver its Warrants to the Company for cancellation, and any Warrants not so delivered shall thereafter cease to be exercisable and shall represent the right to receive the Exchange Warrants pursuant to the terms hereof. The Company shall deliver to the undersigned, or as the undersigned may otherwise direct, the Exchange Warrants to which the undersigned is entitled hereunder at the same time as it delivers the New Warrants pursuant to the terms of the Offering.
     The undersigned hereby represents and warrants that (i) it owns the Warrants free and clear of all liens, claims, encumbrances and other adverse claims whatsoever, (ii) this letter agreement has been duly authorized, executed and delivered by the undersigned and constitutes a valid and binding agreement of the undersigned, enforceable against the undersigned in accordance with its terms and (iii) the undersigned has not paid or received any commission or other remuneration in connection with the Exchange.
[signature page immediately follows]

 


 

             
    Very truly yours,    
 
           
 
  By:        
 
  Title:  
 
   
ACCEPTED AND AGREED,
as of the date first written above.
         
RXI PHARMACEUTICAL CORPORATION
 
       
By:
       
Title:
 
 
Authorized Signatory
   

 


 

Schedule A
         
Class or Series of Warrants   Number of Warrant Shares    
 
       
March 2011 13-Month Warrants
 
 
   
March 2011 5-Year Warrants
 
 
   

 

Exhibit 10.1
Text Marked By [* * *] Has Been Omitted Pursuant To A Request For Confidential Treatment And Was
Filed Separately With The Securities And Exchange Commission.
PATENT AND TECHNOLOGY LICENSE AGREEMENT
     This thirty-nine (39) page AGREEMENT (“AGREEMENT”) is made on this 11th day of September, 2006, by and between: (1) THE BOARD OF REGENTS (“BOARD”) of THE UNIVERSITY OF TEXAS SYSTEM (“SYSTEM”), an agency of the State of Texas, whose address is 201 West 7th Street, Austin, Texas 78701, on behalf of THE UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER (“UTMDACC”), a component institution of SYSTEM; (2) THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC. (“HJF”), a Maryland tax-exempt corporation, whose address is 1401 Rockville Pike, Suite 600, Rockville Maryland 20852, on its own behalf and on behalf of THE UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES (“USU”), an institution of higher learning within the Department of Defense, an agency of the United States Government, located at 4301 Jones Bridge Road, Bethesda, Maryland 20814-4779; and (3) ADVANCED PEPTIDE THERAPEUTICS, INC., a Delaware corporation having a principal place of business located at 9450 E Larkspur Drive, Scottsdale, AZ 85260-8417 (“LICENSEE”).
RECITALS
A.   BOARD and US ARMY originally owned certain PATENT RIGHTS and TECHNOLOGY RIGHTS related to JOINT INVENTION, as defined below, developed by employees of UTMDACC and US ARMY.
B.   US ARMY transferred ownership of its interest in the PATENT RIGHTS and TECHNOLOGY RIGHTS in the JOINT INVENTION to USU, which subsequently assigned its ownership interest therein to HJF, which is the patent management and

1


 

    licensing agent for USU; therefore, the PATENT RIGHTS and TECHNOLOGY RIGHTS in JOINT INVENTION are jointly owned by BOARD and HJF.
C.   BOARD owns certain PATENT RIGHTS and TECHNOLOGY RIGHTS related to BOARD INVENTION, as defined below, developed by Constantin G. Ioannides and Bryan A. Fisk, employees of UTMDACC.
D.   MARIA IOANNIDES, a co-inventor of BOARD INVENTION, was not an employee of UTMDACC at the time BOARD INVENTION was created, but, as indicated on ATTACHMENT A, has assigned all of her right, title and interest in BOARD INVENTION to BOARD.
E.   BOARD, through UTMDACC, and HJF desire to have the LICENSED SUBJECT MATTER developed in the LICENSED FIELD and used for the benefit of LICENSEE, BOARD, SYSTEM, UTMDACC, HJF, the inventor(s), and the public as outlined in BOARD’s Intellectual Property Policy.
F.   LICENSEE wishes to obtain a license from BOARD and HJF to practice LICENSED SUBJECT MATTER.
     NOW, THEREFORE, in consideration of the mutual covenants and promises herein contained, the parties agree as follows:
I. EFFECTIVE DATE
1.1   This AGREEMENT is effective as of the date written above (“EFFECTIVE DATE”), which is the date fully executed by all the parties.
II. DEFINITIONS
    As used in this AGREEMENT, the following terms have the meanings indicated:

2


 

2.1   AFFILIATE means any business entity more than fifty percent (50%) owned by LICENSEE, any business entity which owns more than fifty percent (50%) of LICENSEE, or any business entity that is more than fifty percent (50%) owned by a business entity that owns more than fifty percent (50%) of LICENSEE.
2.2   BOARD INVENTION means the discoveries, know-how, information and inventions created by Constantin G. Ioannides, Bryan A. Fisk and Maria Ioannides and further described in UTMDACC Invention Disclosure Report MDA94-022, entitled “Cancer Therapies by HER-2 Peptides” and/or U.S. Patent No. 6,514,942.
2.3   JOINT INVENTION means the discoveries, know-how, information and inventions created by Constantin G. Ioannides, Martin L. Campbell, Catherine O. O’Brian and George Peoples and further described in UTMDACC Invention Disclosure Report MDA 01-049, entitled “Induction of Tumor Immunity by Controlled Modification of Amino Acid Side Chain Length Using Methyl/Methylene (CH2/CH3)” and/or U.S. Provisional Application No. 60/362,778.
2.4   LICENSED FIELD for JOINT INVENTION (and all PATENT RIGHTS and TECHNOLOGY RIGHTS relating thereto) means the use of the JOINT INVENTION only with HER family (erb-B) peptides and only in the field of human therapeutics. JOINT INVENTION may not be used in connection with any other peptides, including, but not limited to, the modification of peptides other than HER family (erb-B) peptides. LICENSED FIELD for BOARD INVENTION (and all PATENT RIGHTS and TECHNOLOGY RIGHTS relating thereto) means the field of human therapeutics.

3


 

2.5   LICENSED PRODUCTS means any product or service comprising any LICENSED SUBJECT MATTER sold by LICENSEE or any AFFILIATE pursuant to this AGREEMENT.
2.6   LICENSED SUBJECT MATTER means inventions and discoveries covered by PATENT RIGHTS or TECHNOLOGY RIGHTS within LICENSED FIELD.
2.7   LICENSED TERRITORY means worldwide.
2.8   MARKETING APPROVAL means the approval or authorization required for the marketing of a LICENSED PRODUCT in the United States, the European Union or other country within the LICENSED TERRITORY, such as the issuance of an approval action by the United States Food and Drug Administration (“FDA”) on an NDA in the United States, or the issuance of its equivalent by the European Medicines Agency in the European Union.
2.9   NDA means a New Drug Application or Biologics License Application filed with the FDA for MARKETING APPROVAL, or an equivalent application filed with any equivalent agency or governmental authority outside of the United States.
2.10   NET SALES means the gross revenues received by LICENSEE or any AFFILIATE from a SALE less sales discounts actually granted, sales and/or use taxes actually paid, import and/or export duties actually paid, outbound transportation actually prepaid or allowed, and amounts actually allowed or credited due to returns (not exceeding the original billing or invoice amount), all as recorded by LICENSEE in LICENSEE’s official books and records in accordance with generally accepted accounting practices and consistent with LICENSEE’s financial statements and/or regulatory filings with the United States Securities and Exchange Commission, if any.

4


 

2.11   PATENT RIGHTS means BOARD’s and HJF’s rights in information or discoveries described in invention disclosures, or claimed in any patents, and/or patent applications, whether domestic or foreign, and all divisionals, continuations, continuations-in-part, reissues, reexaminations or extensions thereof, and any letters patent that issue thereon as defined in Exhibit I attached hereto.
2.12   PHASE II CLINICAL TRIAL means: (a) that portion of the drug development and review process which provides for early controlled clinical trials conducted to obtain preliminary data on the effectiveness of an investigational new drug for a particular indication, as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21 or any future revisions or substitutes therefor; or (b) a similar clinical trial in any national jurisdiction other than the United States. Commencement of a PHASE II CLINICAL TRIAL shall be deemed to occur upon the administration of LICENSED PRODUCT or placebo to the first patient enrolled in the PHASE II CLINICAL TRIAL.
2.13   PHASE III CLINICAL TRIAL means: (a) that portion of the drug development and review process in which expanded clinical trials are conducted to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of an investigational new drug, as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21 or any future revisions or substitutes therefor; or; (b) a similar clinical trial in any national jurisdiction other than the United States. Commencement of a PHASE III CLINICAL TRIAL shall be deemed to occur upon the administration of LICENSED PRODUCT or placebo to the first patient enrolled in the PHASE III CLINICAL TRIAL.

5


 

2.14   SALE or SOLD means the transfer or disposition of a LICENSED PRODUCT for value to a party other than LICENSEE or AFFILIATE.
2.15   TECHNOLOGY RIGHTS means BOARD’s and HJF’s rights in any and all technical information, know-how, processes, procedures, compositions, devices, methods, formulae, protocols, techniques, software, designs, drawings, or data created by the inventor(s) listed in Exhibit I at UTMDACC or the U S ARMY before the EFFECTIVE DATE, which are not specifically claimed in PATENT RIGHTS but that are necessary for practicing PATENT RIGHTS.
2.16   VALID CLAIM means a claim of: (a) any issued, unexpired patent that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal; or (b) any pending patent application that that has not been cancelled, withdrawn or abandoned.
III. LICENSE
3.1   BOARD, through UTMDACC, and HJF hereby grant to LICENSEE a royalty-bearing, exclusive license under LICENSED SUBJECT MATTER to manufacture, have manufactured, use, import, offer to sell and/or sell LICENSED PRODUCTS within LICENSED TERRITORY for use within LICENSED FIELD. This grant is subject to Sections 14.2 and 14.3 hereinbelow, the payment by LICENSEE to UTMDACC of all consideration as provided herein, the timely payment of all amounts due under any related sponsored research agreement between UTMDACC and/or HJF and LICENSEE in effect during this AGREEMENT, and is further subject to the following rights retained by BOARD, UTMDACC and HJF to:

6


 

  (a)   Publish the general scientific findings from research related to LICENSED SUBJECT MATTER, subject to the terms of Article XI—Confidential Information and Publication; and
  (b)   Use LICENSED SUBJECT MATTER for research, teaching, patient care, and other educationally-related purposes.
3.2   LICENSEE may extend the license granted herein to any AFFILIATE provided that the AFFILIATE consents in writing to be bound by this AGREEMENT to the same extent as LICENSEE. LICENSEE agrees to deliver such contract to UTMDACC within thirty (30) calendar days following execution thereof.
3.3   LICENSEE may grant sublicenses under LICENSED SUBJECT MATTER consistent with the terms of this AGREEMENT provided that LICENSEE is responsible for its sublicensees relevant to this AGREEMENT, and for diligently collecting all amounts due LICENSEE from sublicensees. If a sublicensee pursuant hereto becomes bankrupt, insolvent or is placed in the hands of a receiver or trustee, LICENSEE, to the extent allowed under applicable law and in a timely manner, agrees to use its best reasonable efforts to collect all consideration owed to LICENSEE and to have the sublicense agreement confirmed or rejected by a court of proper jurisdiction.
3.4   LICENSEE must deliver to UTMDACC a true and correct copy of each sublicense granted by LICENSEE, and any modification or termination thereof, within thirty (30) calendar days after execution, modification, or termination.
3.5   If this AGREEMENT is terminated pursuant to Article XIII-Term and Termination, BOARD, UTMDACC and HJF agree to accept as successors to LICENSEE, existing sublicensees in good standing at the date of termination provided that each such

7


 

    sublicensee consents in writing to be bound by all of the terms and conditions of this AGREEMENT.
IV. CONSIDERATION, PAYMENTS AND REPORTS
4.1   In consideration of rights granted by BOARD and HJF to LICENSEE under this AGREEMENT, LICENSEE agrees to pay UTMDACC the following:
  (a)   All reasonable out-of-pocket expenses incurred by UTMDACC and/or HJF in filing, prosecuting, enforcing and maintaining PATENT RIGHTS, and all such future expenses incurred by UTMDACC and/or HJF, for so long as, and in such countries as this AGREEMENT remains in effect. UTMDACC will invoice LICENSEE within thirty (30) calendar days of the EFFECTIVE DATE for such expenses incurred as of that time and on a quarterly basis thereafter. The invoiced amounts will be due and payable by LICENSEE within thirty (30) calendar days of invoice; and
 
  (b)   A nonrefundable license documentation fee in the amount of [***] . This license documentation fee is due and payable as follows: [***] shall be due and payable within thirty (30) days after the EFFECTIVE DATE; the remaining amount of [***] shall be paid on or before the earlier of (1) the first anniversary of the EFFECTIVE DATE, or (2) within thirty (30) days of LICENSEE’s obtaining a commitment of at least seven million dollars ($7,000,000.00) in funding. This license documentation fee will not reduce the amount of any other payment provided for in this ARTICLE IV; and

8


 

  (c)   [***] shares of Common Stock of LICENSEE, par value $.0001 per share, which shall be issued to BOARD and/or its designee(s) within sixty (60) days after this AGREEMENT has been executed by all parties; and
 
  (d)   The following nonrefundable annual license maintenance fees or the total running royalty set forth in Section 4.1(e)(ii) (said royalties being payable quarterly), whichever is greater:
 
  (i)   [***] due on the first anniversary of the EFFECTIVE DATE;
  (ii)   [***] due on the second anniversary of the EFFECTIVE DATE;
 
  (iii)   [***] due on the third anniversary of the EFFECTIVE DATE;
 
  (iv)   [***] due on the fourth anniversary of the EFFECTIVE DATE; and
 
  (v)   [***] due on the fifth anniversary of the EFFECTIVE DATE; and
  (e)   Beginning the quarter following the fifth anniversary of the EFFECTIVE DATE, LICENSEE shall pay UTMDACC, on a quarterly basis, the greater of: (i) an annual minimum royalty of [***] (payable in four equal quarterly installments of [***] each); or (ii) a running royalty (payable quarterly as set forth in Section 4.3, below) which shall be equal to the combined total of all of the following running royalties:
    (i) as to NET SALES of LICENSED PRODUCTS in a given jurisdiction covered by at least one VALID CLAIM existing in such jurisdiction at the time of the relevant SALE: (1) [***] % of the first [***] of such NET SALES; (2) [***] % of the second [***] of such NET SALES; and (3)  [***] % of all such NET SALES in excess of [***] ; and

9


 

    (ii) as to NET SALES of any LICENSED PRODUCT in a given jurisdiction not covered by any VALID CLAIM existing in such jurisdiction at the time of the relevant SALE: (1) [***] % of the first [***] of such NET SALES; (2) [***] % of the second [***] of such NET SALES, and (3)  [***] % of all such NET SALES in excess of [***] ; and
  (f)   The following one-time milestone payments:
  (i)   Commencement of Phase III Clinical Trial for a LICENSED PRODUCT $ [***]
 
  (ii)   Filing of an NDA for a LICENSED PRODUCT $ [***]
 
  (iii)   Marketing Approval of a LICENSED PRODUCT $ [***]
 
  (iv)   First SALE of a LICENSED PRODUCT $ [***]
      For purposes hereof, “Commencement” means administration of the first dose to a human. Each of the foregoing milestone payments shall be made by LICENSEE to UTMDACC within thirty (30) days of achieving the milestone event and shall [***] reduce the amount of any other payment provided for in this ARTICLE IV; and
  (g)   The following percentages of all consideration, other than research and development money, due within thirty (30) days of receipt, received by LICENSEE from either (i) any sublicensee pursuant to Sections 3.3 and 3.4 hereinabove, or (ii) any assignee pursuant to Section 12.1 hereinbelow (in consideration for UTMDACC and HJF allowing the assignment), including but not limited to, royalties, up-front payments, marketing, distribution, franchise, option, license, or documentation fees, bonus and milestone payments and equity securities:

10


 

  (i)   [***] % if sublicensed or assigned after the EFFECTIVE DATE but prior to the commencement of a Phase II Clinical Trial;
  (ii)   [***] % if sublicensed or assigned after the commencement of a Phase II Clinical Trial but prior to the commencement of a Phase III Clinical Trial;
  (iii)   [***] % if sublicensed or assigned after commencement of a Phase III Clinical Trial, but prior to the filing of an NDA; and
  (iv)   [***] % if sublicensed or assigned after filing of an NDA.
4.2   If LICENSEE is obligated to pay running royalties to a third party to avoid infringing such third party’s patent rights which dominate the PATENT RIGHTS, as documented by a written opinion of LICENSEE’S outside patent counsel, a copy of which is provided to UTMDACC, LICENSEE may reduce the running royalties due UTMDACC by [***] of the running royalty rate actually being paid to such third party, provided that the running royalty rate due UTMDACC will not be reduced by more than [***] of the royalty rates specified in Section 4.1(e) and in no event shall be less than [***] .
4.3   Unless otherwise provided, all such payments are payable within thirty (30) calendar days after March 31, June 30, September 30, and December 31 of each year during the term of this AGREEMENT, at which time LICENSEE will also deliver to UTMDACC a true and accurate report, giving such particulars of the business conducted by LICENSEE and its sublicensees, if any exist, during the preceding three calendar months under this AGREEMENT as necessary for UTMDACC to account for LICENSEE’s payments hereunder. This report will include pertinent data, including, but not limited to:

11


 

  (a)   the accounting methodologies used to account for and calculate the items included in the report and any differences in such accounting methodologies used by LICENSEE since the previous report; and
  (b)   a list of LICENSED PRODUCTS produced for the three (3) preceding calendar months categorized by the technology it relates to under PATENT RIGHTS and whether or not it is covered by a VALID CLAIM; and
  (c)   the total quantities of LICENSED PRODUCTS produced by the categories listed in Section 4.3(b); and
  (d)   the total SALES by the categories listed in Section 4.3(b); and
  (e)   the calculation of NET SALES by the categories listed in Section 4.3(b); and
  (f)   the royalties so computed and due UTMDACC by the categories listed in Section 4.3(b) and/or minimum royalties; and
  (g)   all consideration received from each sublicensee or assignee and payments due UTMDACC; and
  (h)   all other amounts due UTMDACC herein. Simultaneously with the delivery of each such report, LICENSEE agrees to pay UTMDACC the amount due, if any, for the period of such report. These reports are required even if no payments are due.
4.4   During the term of this AGREEMENT and for three (3) years thereafter, LICENSEE agrees to keep complete and accurate records of its and its sublicensees’ SALES and NET SALES in sufficient detail to enable the royalties and other payments due hereunder to be determined. LICENSEE agrees to permit UTMDACC or its representatives, at UTMDACC’s expense, to periodically examine LICENSEE’s books, ledgers, and records

12


 

    during regular business hours for the purpose of and to the extent necessary to verify any report required under this AGREEMENT. If any amounts due UTMDACC are determined to have been underpaid in an amount equal to or greater than five percent (5%) of the total amount due during the period so examined, then LICENSEE will pay the cost of the examination plus accrued interest at the highest allowable rate.
4.5   Within thirty (30) calendar days following each anniversary of the EFFECTIVE DATE, LICENSEE will deliver to UTMDACC a written progress report as to LICENSEE’s (and any sublicensee’s) efforts and accomplishments during the preceding year in diligently commercializing LICENSED SUBJECT MATTER in the LICENSED TERRITORY and LICENSEE’s (and sublicensees’) commercialization plans for the upcoming year. UTMDACC may provide copies of any progress, royalty or other reports provided by LICENSEE to UTMDACC under this AGREEMENT in confidence to HJF, which may provide the same in confidence to USU and/or US ARMY.
4.6   All amounts payable hereunder by LICENSEE will be paid in United States funds without deductions for taxes, assessments, fees, or charges of any kind. Checks are to be made payable to The University of Texas M. D. Anderson Cancer Center, and sent by United States mail to Box 297402, Houston, Texas 77297, Attention: Manager, Sponsored Programs or by wire transfer to:
    JPMorgan Chase Bank, N.A.
910 Travis
Houston, Texas 77002
SWIFT: [***]
ABA ROUTING NO: [***]
ACCOUNT NAME: [***]
ACCOUNT NO.: [***]
    REFERENCE: include title and EFFECTIVE DATE of AGREEMENT and type of payment (e.g., license documentation fee, milestone payment, royalty [including

13


 

    applicable patent/application identified by MDA reference number and patent number or application serial number], or maintenance fee, etc.).
4.7   No payments due or royalty rates owed under this AGREEMENT will be reduced as the result of co-ownership of LICENSED SUBJECT MATTER by BOARD and/or HJF, and another party, including, but not limited to, LICENSEE.
V. SPONSORED RESEARCH
5.1   If LICENSEE desires to sponsor research for or related to the LICENSED SUBJECT MATTER, and particularly where LICENSEE receives payments for sponsored research pursuant to a sublicense under this AGREEMENT, LICENSEE (a) will notify UTMDACC and/or HJF in writing of all opportunities to conduct this sponsored research (including clinical trials, if applicable), (b) will solicit research and/or clinical proposals from UTMDACC and/or HJF for this purpose, and (c) will give good faith consideration to funding the proposals at UTMDACC and/or HJF.
VI. PATENTS AND INVENTIONS
6.1   If after consultation with LICENSEE, the parties agree that a new patent application should be filed for LICENSED SUBJECT MATTER, UTMDACC will prepare and file appropriate patent applications, and LICENSEE will pay the reasonable cost of searching, preparing, filing, prosecuting and maintaining same. If LICENSEE notifies UTMDACC that it does not intend to pay the cost of an application, or if LICENSEE does not respond or make an effort to agree with UTMDACC and HJF on the disposition of rights of the subject invention, then UTMDACC may file such application at its own expense and LICENSEE’s rights to such invention under this AGREEMENT shall terminate in their entirety. UTMDACC will provide LICENSEE with a copy of the

14


 

    application for which LICENSEE has paid the cost of filing, as well as copies of any documents received or filed during prosecution thereof. The parties agree that they share a common legal interest to get valid enforceable patents and that LICENSEE will keep all privileged information received pursuant to this Section confidential.
VII. INFRINGEMENT BY THIRD PARTIES
7.1   LICENSEE, at its expense, must enforce any patent exclusively licensed hereunder against infringement by third parties and is entitled to retain recovery from such enforcement. After reimbursement of LICENSEE’s reasonable legal costs and expenses related to such recovery, LICENSEE agrees to pay UTMDACC either: (a) the royalty detailed in Section 4.1(e) for any monetary recovery that is for sales of LICENSED PRODUCTS lost due to the infringement and related punitive damages; or (b) [***] of reasonable royalties awarded and related punitive damages in any recovery in which the award is for reasonable royalties. LICENSEE must notify UTMDACC in writing of any potential infringement within thirty (30) calendar days of knowledge thereof. If LICENSEE does not file suit against a substantial infringer within six (6) months of knowledge thereof, then BOARD, UTMDACC and/or HJF (“ENFORCING PARTY or PARTIES”) may, at its sole discretion, enforce any patent licensed hereunder on behalf of itself and LICENSEE, with ENFORCING PARTY or PARTIES retaining all recoveries from such enforcement, and/or reduce the license granted hereunder to non-exclusive.
7.2   In any suit or dispute involving an infringer, the parties agree to cooperate fully with each other. At the request and expense of the party or parties bringing suit, the other party or

15


 

    parties will permit access during regular business hours, to all relevant personnel, records, papers, information, samples, specimens, and the like in its possession.
VIII. PATENT MARKING
8.1   LICENSEE agrees that all packaging containing individual LICENSED PRODUCT(S), documentation therefor, and when possible for actual LICENSED PRODUCT(S) sold by LICENSEE, AFFILIATES, and/or sublicensees of LICENSEE will be permanently and legibly marked with the number of any applicable patent(s) licensed hereunder in accordance with each country’s patent laws, including Title 35, United States Code.
IX. INDEMNIFICATION AND INSURANCE
9.1   LICENSEE agrees to hold harmless and indemnify BOARD, SYSTEM, UTMDACC, HJF, USU, US ARMY, and their Regents, officers, employees, students and agents from and against any claims, demands, or causes of action whatsoever, costs of suit and reasonable attorney’s fees, including without limitation, those costs arising on account of any injury or death of persons or damage to property caused by, or arising out of, or resulting from, the exercise or practice of the rights granted hereunder by LICENSEE, its officers, its AFFILIATES or their officers, employees, agents or representatives.
9.2   In no event shall BOARD, SYSTEM, UTMDACC, HJF, USU or US ARMY be liable for any indirect, special, consequential or punitive damages (including, without limitation, damages for loss of profits or expected savings or other economic losses, or for injury to persons or property) arising out of, or in connection with, this AGREEMENT or its subject matter, regardless of whether BOARD, SYSTEM, UTMDACC, HJF, USU or US ARMY knows or should know of the possibility of such damages.

16


 

9.3   Beginning at the time when any LICENSED SUBJECT MATTER is being distributed or sold (including for the purpose of obtaining regulatory approvals) by LICENSEE or by a sublicensee, LICENSEE shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts not less than $2,000,000 per incident and $2,000,000 annual aggregate, and LICENSEE shall use reasonable efforts to have the BOARD, SYSTEM, UTMDACC, HJF, USU, US ARMY, and their Regents, officers, employees, students and agents named as additional insureds. Such commercial general liability insurance shall provide: (i) product liability coverage; (ii) broad form contractual liability coverage for LICENSEE’s indemnification under this AGREEMENT; and (iii) coverage for litigation costs. The minimum amounts of insurance coverage required herein shall not be construed to create a limit of LICENSEE’s liability with respect to its indemnification under this AGREEMENT.
9.4   LICENSEE shall provide UTMDACC with written evidence of such insurance within thirty (30) days of its procurement. Additionally, LICENSEE shall provide UTMDACC with written notice of at least fifteen (15) days prior to the cancellation, non-renewal or material change in such insurance.
9.5   LICENSEE shall maintain such commercial general liability insurance beyond the expiration or termination of this AGREEMENT during: (i) the period that any LICENSED SUBJECT MATTER developed pursuant to this AGREEMENT is being commercially distributed or sold by LICENSEE or by a sublicensee or agent of LICENSEE; and (ii) the five (5) year period immediately after such period.

17


 

X. USE OF NAME
10.1   LICENSEE will not use the name of (or the name of any employee of) UTMDACC, SYSTEM, BOARD, HJF, USU and/or US ARMY in any advertising, promotional or sales literature, on its Web site, or for the purpose of raising capital without the advance express written consent of the appropriate party secured through:
    For UTMDACC, SYSTEM or BOARD:
    The University of Texas
M. D. Anderson Cancer Center, Legal Services
P.O. Box 301439, Unit 0537
Houston, TX 77230-1439
ATTENTION: Natalie Wright
Email : [***]
    For HJF:
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.
1401 Rockville Pike, Suite 600
Rockville, MD 20852
ATTENTION: General Counsel
Email: [***]
    For USU or US ARMY:
The Uniformed Services University of the Health Sciences
4301 Jones Bridge Road
Room A1030
Bethesda, MD 20814
ATTENTION: General Counsel
Email: [***]
    Notwithstanding the above, LICENSEE may use the name of (or name of employee of) UTMDACC, SYSTEM or BOARD in routine business correspondence, or as needed in appropriate regulatory submissions without express written consent.
XI. CONFIDENTIAL INFORMATION AND PUBLICATION
11.1   UTMDACC, HJF and LICENSEE each agree that all information contained in documents marked “confidential” and forwarded to one party by another (i) are to be received in strict confidence, (ii) are to be used only for the purposes of this

18


 

    AGREEMENT, and (iii) will not be disclosed by the recipient party (except as required by law or court order), its agents or employees without the prior written consent of the disclosing party, except to the extent that the recipient party can establish by competent written proof that such information:
  (a)   was in the public domain at the time of disclosure; or
  (b)   later became part of the public domain through no act or omission of the recipient party, its employees, agents, successors or assigns; or
  (c)   was lawfully disclosed to the recipient party by a third party having the right to disclose it; or
  (d)   was already known by the recipient party at the time of disclosure as substantiated by recipient’s written records; or
  (e)   was independently developed by the recipient party without use of the disclosing party’s confidential information; or
  (f)   is required by law or regulation to be disclosed.
11.2   Each party’s obligation of confidence hereunder will be fulfilled by using at least the same degree of care with the disclosing party’s confidential information as it uses to protect its own confidential information, but always at least a reasonable degree of care. This obligation will exist while this AGREEMENT is in force and for a period of three (3) years thereafter.
11.3   UTMDACC and HJF each reserves the right to publish the general scientific findings from research related to LICENSED SUBJECT MATTER, with due regard to the protection of LICENSEE’s confidential information. UTMDACC or HJF (whichever plans to publish) will submit the manuscript of its proposed publication to LICENSEE at

19


 

    least thirty (30) calendar days before publication, and LICENSEE shall have the right to review and comment upon the publication in order to protect LICENSEE’s confidential information. Upon LICENSEE’s request, publication may be delayed up to sixty (60) additional calendar days to enable LICENSEE to secure adequate intellectual property protection of LICENSEE’s confidential information that would otherwise be affected by the publication.
XII. ASSIGNMENT
12.1   Except in connection with the sale of all of LICENSEE’s assets to a third party, this AGREEMENT may not be assigned by LICENSEE without the prior written consent of UTMDACC and HJF, which will not be unreasonably withheld or delayed.
XIII. TERM AND TERMINATION
13.1   Subject to Sections 13.3 and 13.4 hereinbelow, the term of this AGREEMENT is from the EFFECTIVE DATE to the date upon which all PATENT RIGHTS have expired, or all claims in the PATENT RIGHTS have been declared invalid or unenforceable by a court or tribunal in a final decision not subject to further appeal, or have been abandoned.
13.2   Any time after two (2) years from the EFFECTIVE DATE, BOARD or UTMDACC have the right to terminate this license in any national political jurisdiction within the LICENSED TERRITORY if LICENSEE, within ninety (90) calendar days after receiving written notice from UTMDACC of the intended termination, fails to provide written evidence satisfactory to UTMDACC that LICENSEE or its sublicensee(s) has commercialized or is actively and effectively attempting to commercialize a licensed invention in such jurisdiction(s). The following definitions apply to Section 13.2: (a) “commercialize” means having SALES in such jurisdiction; (b) “active attempts to

20


 

    commercialize” means conducting an effective ongoing and active research, development, manufacturing, marketing or sales program as appropriate, directed toward obtaining regulatory approval, and/or production and/or SALES in any jurisdiction, and has provided plans acceptable to UTMDACC, in its sole discretion, to commercialize licensed inventions in the jurisdiction(s) that UTMDACC intends to terminate.
13.3   Subject to any rights herein which survive termination, this AGREEMENT will earlier terminate in its entirety:
  (a)   automatically, if LICENSEE becomes bankrupt or insolvent and/or if the business of LICENSEE shall be placed in the hands of a receiver, assignee, or trustee, whether by voluntary act of LICENSEE or otherwise; or
  (b)   upon thirty (30) calendar days written notice from UTMDACC, if LICENSEE breaches or defaults on the payment or report obligations of ARTICLE IV, or use of name obligations of ARTICLE X, unless, before the end of the such thirty (30)-calendar day notice period, LICENSEE has cured the default or breach to UTMDACC’s satisfaction, and so notifies UTMDACC, stating the manner of the cure; or
  (c)   upon thirty (30) calendar days written notice from UTMDACC, if LICENSEE fails to commence a Phase II Clinical Trial or Phase III Clinical Trial in the United States or the European Union within twenty four (24) months of the EFFECTIVE DATE, unless, before the end of such thirty (30) day period, LICENSEE provides evidence satisfactory to UTMDACC that it has commenced the Clinical Trial; or

21


 

  (d)   upon thirty (30) calendar days written notice from UTMDACC, if LICENSEE fails to acquire at least seven million dollars ($7,000,000.00) in funding (whether by debt, equity, merger, reverse merger, grant, corporate partnering or sublicensing) and provides evidence of same to UTMDACC within twelve (12) months of the EFFECTIVE DATE; or
 
  (e)   upon ninety (90) calendar days written notice from UTMDACC if LICENSEE breaches or defaults on any other obligation under this AGREEMENT, unless, before the end of the such ninety (90) calendar-day notice period, LICENSEE has cured the default or breach to UTMDACC’s satisfaction and so notifies UTMDACC, stating the manner of the cure; or
 
  (f)   at any time by mutual written agreement between LICENSEE, UTMDACC and HJF upon one hundred eighty (180) calendar days written notice to all parties and subject to any terms herein which survive termination; or
 
  (g)   if Section 13.2 is invoked; or
 
  (h)   if LICENSEE has defaulted or been late on its payment obligations pursuant to the terms of this AGREEMENT on any two (2) occasions in a twelve (12) month period.
13.4   Upon termination of this AGREEMENT:
  (a)   nothing herein will be construed to release any party of any obligation maturing prior to the effective date of the termination; and
 
  (b)   LICENSEE covenants and agrees to be bound by the provisions of Articles IX (Indemnification and Insurance), X (Use of Name) and XI (Confidential Information and Publication) of this AGREEMENT; and

22


 

  (c)   LICENSEE may, after the effective date of the termination, sell all LICENSED PRODUCTS and parts therefor that it has on hand at the date of termination, if LICENSEE pays the earned royalty thereon and any other amounts due pursuant to Article IV of this AGREEMENT; and
 
  (d)   Subject to Section 13.4(c), LICENSEE agrees to cease and desist any use and all SALE of the LICENSED SUBJECT MATTER and LICENSED PRODUCTS upon termination of this AGREEMENT; and
 
  (e)   LICENSEE grants to BOARD, UTMDACC and HJF a nonexclusive royalty bearing license with the right to sublicense specific fields of use outside of the LICENSED FIELD to others with respect to improvements made by LICENSEE (including improvements licensed by LICENSEE from third parties) in the LICENSED SUBJECT MATTER. LICENSEE, UTMDACC and HJF agree to negotiate in good faith the royalty rate for the nonexclusive license. BOARD’s, UTMDACC’s and HJF’s right to sublicense others hereunder is solely for the purpose of permitting others to develop and commercialize the entire technology package.
XIV. WARRANTY: SUPERIOR-RIGHTS
14.1   Except for the rights, if any, of the Government of the United States of America as set forth below and subject to the limitations set forth in Section 14.2, BOARD and HJF represent and warrant their belief that (a) they are the owners of the entire right, title, and interest in and to LICENSED SUBJECT MATTER, (b) they have the sole right to grant licenses thereunder, and (c) they have not knowingly granted licenses thereunder to any other entity that would restrict rights granted hereunder except as stated herein.

23


 

14.2   As more specifically set forth in ATTACHMENT A, Maria Ioannides has assigned her right, title and interest as a co-inventor of BOARD INVENTION to BOARD, and has represented and warranted to BOARD that her interest in the BOARD INVENTION is not obligated to a third party and that she is free to transfer her interest in the BOARD INVENTION to BOARD. BOARD and UTMDACC do not represent or warrant the extent of Maria Ioannides’ interest in BOARD INVENTION. BOARD’s rights and interest in any Patent Rights, Technology Rights and/or Licensed Subject Matter as a result of Maria Ioannides being a co-inventor thereof are limited to the rights granted to the BOARD by Maria Ioannides in ATTACHMENT A.
14.3   LICENSEE understands that the LICENSED SUBJECT MATTER may have been developed by an employee or employees of, or under a funding agreement with the Government of the United States of America and, if so, that the Government may have certain rights relative thereto. This AGREEMENT is explicitly made subject to the Government’s rights under any such agreement and any applicable law or regulation, including P.L. 96-517 as amended by P.L. 98-620. To the extent that there is a conflict between any such agreement, applicable law or regulation and this AGREEMENT, the terms of such Government agreement, applicable law or regulation shall prevail. In addition, the Government retains the right to use the INVENTION and/or PATENT RIGHTS for noncommercial research purposes. LICENSEE agrees that LICENSED PRODUCTS used or SOLD in the United States will be manufactured substantially in the United States, unless a written waiver is obtained in advance from the GOVERNMENT.
14.4   LICENSEE understands and agrees that BOARD, UTMDACC and HJF by this AGREEMENT, make no representation as to the operability or fitness for any use, safety,

24


 

    efficacy, approvability by regulatory authorities, time and cost of development, patentability, and/or breadth of the LICENSED SUBJECT MATTER. BOARD, UTMDACC and HJF, by this AGREEMENT, also make no representation as to whether any patent covered by PATENT RIGHTS is valid or as to whether there are any patents now held, or which will be held, by others or by BOARD, UTMDACC or HJF in the LICENSED FIELD, nor do BOARD, UTMDACC and HJF make any representation that the inventions contained in PATENT RIGHTS do not infringe any other patents now held or that will be held by others or by BOARD or HJF.
14.5   LICENSEE, by execution hereof, acknowledges, covenants and agrees that LICENSEE has not been induced in any way by BOARD, SYSTEM, UTMDACC, HJF or employees thereof to enter into this AGREEMENT, and further warrants and represents that (a) LICENSEE has conducted sufficient due diligence with respect to all items and issues pertaining to this AGREEMENT; and (b) LICENSEE has adequate knowledge and expertise, or has used knowledgeable and expert consultants, to adequately conduct such due diligence, and agrees to accept all risks inherent herein.
XV. GENERAL
15.1   This AGREEMENT constitutes the entire and only agreement between the parties for LICENSED SUBJECT MATTER and all other prior negotiations, representations, agreements and understandings are superseded hereby. No agreements altering or supplementing the terms hereof will be made except by a written document signed by all parties.
15.2   Any notice required by this AGREEMENT must be given by prepaid, first class, certified mail, return receipt requested, and addressed in the case of UTMDACC to:

25


 

The University of Texas M. D. Anderson Cancer Center
Office of Technology Commercialization
7515 S. Main, Suite 490, Unit 0510
Houston, Texas 77030
ATTENTION: Christopher C. Capelli
with copy to BOARD:
BOARD OF REGENTS
The University of Texas System
201 West Seventh Street
Austin, Texas 78701
ATTENTION: Office of General Counsel
In the case of LICENSEE to:
Advanced Peptide Therapeutics, Inc.
9450 E Larkspur Drive
Scottsdale, Arizona 85260-8417
ATTENTION: Robert E Kennedy
Or in the case of HJF to:
The Henry M. Jackson Foundation for
the Advancement of Military Medicine, Inc.
1401 Rockville Pike, Suite 600
Rockville, Maryland 20852
ATTENTION: General Counsel
or other addresses as may be given from time to time under the terms of this notice provision.
15.3   LICENSEE must comply with all applicable federal, state and local laws and regulations in connection with its activities pursuant to this AGREEMENT.
15.4   This AGREEMENT will be construed and enforced in accordance with the laws of the United States of America and of the State of Texas, without regard to its conflict of law provisions. The Texas State Courts of Harris County, Texas (or, if there is exclusive federal jurisdiction, the United States District Court for the Southern District of Texas)

26


 

    shall have exclusive jurisdiction and venue over any dispute arising out of this AGREEMENT, and LICENSEE consents to the jurisdiction of such courts; however, nothing herein shall be deemed as a waiver by BOARD, SYSTEM or UTMDACC of its sovereign immunity.
15.5   Any dispute or controversy arising out of or relating to this AGREEMENT, its construction or its actual or alleged breach will be decided by mediation. If the mediation does not result in a resolution of such dispute or controversy, it will be finally decided by an appropriate method of alternate dispute resolution, including without limitation, arbitration, conducted in the city of Houston, Harris County, Texas, in accordance with the applicable, then-current procedures of the American Arbitration Association. The arbitration panel will include members knowledgeable in the evaluation of the LICENSED SUBJECT MATTER. Judgment upon the award rendered may be entered in the highest court or forum having jurisdiction, state or federal. The provisions of this Section 15.5 will not apply to decisions on the validity of patent claims or to any dispute or controversy as to which any treaty or law prohibits such arbitration. The decision of the arbitration must be sanctioned by a court of law having jurisdiction to be binding upon and enforceable by the parties.
15.6   Failure of BOARD, UTMDACC or HJF to enforce a right under this AGREEMENT will not act as a waiver of right or the ability to later assert that right relative to the particular situation involved.
15.7   Headings included herein are for convenience only and will not be used to construe this AGREEMENT.

27


 

15.8   If any part of this AGREEMENT is for any reason found to be unenforceable, all other parts nevertheless will remain enforceable.
IN WITNESS WHEREOF , the parties hereto have caused their duly authorized representatives to execute this AGREEMENT.
                     
BOARD OF REGENTS OF THE
UNIVERSITY OF TEXAS SYSTEM
      ADVANCED PEPTIDE THERAPEUTICS,
INC.
   
 
By
  /s/ John Mendelsohn, M.D.       By   /s/ Robert E. Kennedy    
 
 
 
         
 
   
 
  John Mendelsohn, M.D.           Name: Robert E. Kennedy    
 
  President           Title: President and CFO    
 
  The University of Texas                
 
  M. D. Anderson Cancer Center                
 
Date: 9/11/06       Date: 8/16/06    
 
                   
THE UNIVERSITY OF TEXAS
M. D. ANDERSON CANCER CENTER
      THE HENRY M. JACKSON
FOUNDATION FOR THE
   
 
          ADVANCEMENT OF MILITARY
MEDICINE, INC.
   
By
  /s/ Leon Leach
 
Leon Leach
Executive Vice President
The University of Texas
M. D. Anderson Cancer Center
     
By
 
/s/ John W. Lowe
 
John W. Lowe
President
   
 
                   
Date: 9/7/06       Date: 8/24/06    
 
                   
         
Approved as to Content:
 
 
By  /s/ Christopher C. Capelli      
  Christopher C. Capelli   
  Vice President, Technology Transfer
M. D. Anderson Cancer Center 
 
Date: 8/20/06

28


 

EXHIBIT I
     MDA94-022, entitled “Cancer Therapies by HER-2 Peptides , ” and U. S. Patent No. 6,514,942, created by Constantin G. Ioannides, Bryan A. Fisk and Maria Ioannides (owned by BOARD).
     MDA 01-049, entitled “Induction of Tumor Immunity by Controlled Modification of Amino Acid Side Chain Length Using Methyl/Methylene (CH2/CH3) , ” and U. S. Provisional Application No. 60/362,778, created by Constantin G. Ioannides, Martin L. Campbell, Catherine O. O’Brian and George Peoples (jointly owned by BOARD and HJF).

29


 

ATTACHMENT A
(Assignment Agreement and Assignment)
[***]

30

Exhibit 10.2
AMENDMENT NO. 1 TO THE
PATENT AND TECHNOLOGY LICENSE AGREEMENT
This AMENDMENT NO. 1 to the Exclusive PATENT AND TECHNOLOGY LICENSE AGREEMENT between the PARTIES dated September 11, 2006 (“ORIGINAL LICENSE”), effective the 21st day of December, 2007 (which is the date this AMENDMENT NO. 1 has been fully executed by all PARTIES), is made by and between: (1) THE BOARD OF REGENTS (“BOARD”) of THE UNIVERSITY OF TEXAS SYSTEM (“SYSTEM”), an agency of the State of Texas, whose address is 201 West 7th Street, Austin, Texas 78701, on behalf of THE UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER (“UTMDACC”), a component institution of SYSTEM; (2) THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC. (“HJF”), a Maryland tax-exempt corporation, whose address is 140 1 Rockville Pike, Suite 600, Rockville, Maryland 20852, on its own behalf and on behalf of THE UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES (“USU”), an institution of higher learning within the Department of Defense, an agency of the United States Government, located at 4301 Jones Bridge Road, Bethesda, Maryland 20814-4779; and (3) APTHERA, INC. (formerly known as ADVANCED PEPTIDE THERAPEUTICS, INC.; hereafter referred to as “LICENSEE”). BOARD, HJF and LICENSEE may be referred to hereafter collectively as the “PARTIES.”
RECITALS
A. ADVANCED PEPTIDE THERAPEUTICS, INC., a Delaware corporation having a principal place of business located at 9450 E. Larkspur Drive, Scottsdale, Arizona 85260- 8417, has changed its name since execution of the ORIGINAL LICENSE to APTHERA, INC.
B. BOARD, HJF and LICENSEE desire to amend the ORIGINAL LICENSE.
NOW, THEREFORE, in consideration of the mutual covenants contained herein, the sufficiency of which is hereby acknowledged, the PARTIES hereby agree to the following:
AMENDED TERMS
1.   Section 13.3(d) of ORIGINAL LICENSE shall be deleted in its entirety and replaced with the following:
 
    13.3(d) upon thirty (30) calendar days written notice from UTMDACC, if LICENSEE fails to acquire at least seven million dollars ($7,000,000.00) in funding (whether by debt, equity, merger, reverse merger, grant, corporate partnering or sublicensing) and provides evidence of same to UTMDACC on or before June 30, 2008; or
 
2.   The PARTIES acknowledge and agree that, except as set forth in this AMENDMENT NO. 1 the terms and conditions of the ORIGINAL LICENSE shall remain in full force and effect.

1


 

IN WITNESS WHEREOF, the PARTIES hereto have caused their duly authorized representatives to execute this AMENDMENT NO. 1.
             
BOARD OF REGENTS OF THE   APTHERA, INC.
UNIVERSITY OF TEXAS SYSTEM        
 
By:  /s/ John Mendelsohn, M.D.   By:  /s/ Robert E. Kennedy
  John Mendelsohn, M.D. President     Name:  Robert E. Kennedy
  The University of Texas     Title: President and CFO
  M. D. Anderson Cancer Center  
Date: 12/06/07
Date: 12/21/07
             
THE UNIVERSITY OF TEXAS   THE HENRY M. JACKSON FOUNDATION FOR
M. D. ANDERSON CANCER CENTER   THE ADVANCEMENT OF MILITARY MEDICINE, INC.
 
By:  /s/ Leon Leach   By:  /s/ John W. Lowe
  Leon Leach     John W. Lowe
  Executive Vice President     President
  The University of Texas
M. D. Anderson Cancer Center

Date: 12/11/07
Date: 12/21/07
         
Approved as to Content:
 
 
By:   /s/ Christopher C. Capelli      
  Christopher C. Capelli   
  Vice President, Technology Transfer
M. D. Anderson Cancer Center 
 
 
Date: 12/17/07

2

Exhibit 10.3
AMENDMENT NO. 2 TO THE
PATENT AND TECHNOLOGY LICENSE AGREEMENT
     This AMENDMENT NO. 2 to the Exclusive PATENT AND TECHNOLOGY LICENSE AGREEMENT between the PARTIES dated September 11, 2006, as amended on December 21, 2007 (the “LICENSE AGREEMENT”), effective the 3rd day of September, 2008 (which is the date this AMENDMENT NO. 2 has been fully executed by all PARTIES), is made by and between: (1) THE BOARD OF REGENTS (“BOARD”) of THE UNIVERSITY OF TEXAS SYSTEM (“SYSTEM”), an agency of the State of Texas, whose address is 201 West 7th Street, Austin, Texas 78701, on behalf of THE UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER (“UTMDACC”), a component institution of SYSTEM; (2) THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC. (“HJF”), a Maryland tax-exempt corporation, whose address is 1401 Rockville Pike, Suite 600, Rockville, Maryland 20852, on its own behalf and on behalf of THE UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES (“USU”), an institution of higher learning within the Department of Defense, an agency of the United States Government, located at 4301 Jones Bridge Road, Bethesda, Maryland 20814-4779; and (3) APTHERA, INC. (formerly known as ADVANCED PEPTIDE THERAPEUTICS, INC.; hereafter referred to as “LICENSEE”). BOARD, HJF and LICENSEE may be referred to herein collectively as the “PARTIES”.
RECITALS
A.   The LICENSE AGREEMENT requires LICENSEE to achieve certain performance milestones within a specified period of time.
 
B.   BOARD and HJF desire to provide LICENSEE with additional time in which to complete those performance milestones.
 
C.   Accordingly, BOARD, HJF and LICENSEE desire to amend the LICENSE AGREEMENT pursuant to the terms and conditions set forth herein.
     NOW, THEREFORE, in consideration of the mutual covenants contained herein, the sufficiency of which is hereby acknowledged, the PARTIES hereby agree to the following:

1


 

AMENDMENT
1.   Section 13.3(c) of the LICENSE AGREEMENT shall be deleted in its entirety and replaced with the following:
  13.3   (c) upon thirty (30) calendar days written notice from UTMDACC, if LICENSEE fails to commence a Phase II Clinical Trial or Phase III Clinical Trial in the United States or the European Union on or before September 30, 2009, unless, before the end of such thirty (30) day period, LICENSEE provides evidence satisfactory to UTMDACC that it has commenced the Clinical Trial; or
2.   Section 13.3(d) of the LICENSE AGREEMENT shall be deleted in its entirety and replaced with the following:
  13.3   (d) upon thirty (30) calendar days written notice from UTMDACC, if LICENSEE fails to acquire at least seven million dollars ($7,000,000.00) in funding (whether by debt, equity, merger, reverse merger, grant, corporate partnering or sublicensing) and provides evidence of same to UTMDACC on or before February 28, 2009; or
3.   The PARTIES acknowledge and agree that, except as set forth in this AMENDMENT NO. 2 the terms and conditions of the LICENSE AGREEMENT shall remain unchanged and in full force and effect; provided, however, that nothing contained in the LICENSE AGREEMENT shall have the effect of preventing or limiting, in any way, the terms of this AMENDMENT NO. 2. If any conflict arises between the terms of this AMENDMENT NO. 2 and the terms of the LICENSE AGREEMENT, this AMENDMENT NO. 2 shall govern as to the conflicting terms.
 
4.   This AMENDMENT NO. 2 shall be binding upon and inure to the benefit of the parties hereto and their respective heirs, administrators, executors, successors, and assigns.
 
5.   This AMENDMENT NO. 2 may be executed in one or more counterparts, each of which shall be considered an original, but all of which together shall be deemed to be one and the same document.
[REMINDER OF PAGE INTENTIONALLY BLANK]

2


 

      IN WITNESS WHEREOF , the PARTIES hereto have caused their duly authorized representatives to execute this AMENDMENT NO 2.
             
BOARD OF REGENTS OF THE   APTHERA, INC.
UNIVERSITY OF TEXAS SYSTEM        
 
By  /s/ John Mendelsohn, M.D.   By  /s/ Robert E. Kennedy
  Name:  John Mendelsohn, M.D. President     Name:  Robert E. Kennedy
  Title: The University of Texas     Title: President and CFO
  M. D. Anderson Cancer Center  
Date: 8/4/08
Date: 9/3/08
             
THE UNIVERSITY OF TEXAS   THE HENRY M. JACKSON FOUNDATION FOR
M. D. ANDERSON CANCER CENTER   THE ADVANCEMENT OF MILITARY MEDICINE, INC.
 
By  /s/ Leon Leach   By  /s/ John W. Lowe
  Leon Leach     John W. Lowe
  Executive Vice President     President
  The University of Texas
M. D. Anderson Cancer Center

Date: 8/5/08
Date: 8/27/08
         
Approved as to Content:
 
 
By   /s/ Christopher C. Capelli      
  Christopher C. Capelli   
  Vice President, Technology Transfer M. D. Anderson Cancer Center   
 
Date: 8/17/08

3

Exhibit 10.4
AMENDMENT NO. 3 TO THE
PATENT AND TECHNOLOGY LICENSE AGREEMENT
     This AMENDMENT NO. 3 to the Exclusive PATENT AND TECHNOLOGY LICENSE AGREEMENT between the PARTIES dated September 11, 2006, as amended on December 21, 2007 and September 3, 2008 (the “LICENSE AGREEMENT”), effective the 8th day of July, 2009 (which is the date this AMENDMENT NO. 3 has been fully executed by all PARTIES), is made by and between: (1) THE BOARD OF REGENTS (“BOARD”) of THE UNIVERSITY OF TEXAS SYSTEM (“SYSTEM”), an agency of the State of Texas, whose address is 201 West 7th Street, Austin, Texas 78701, on behalf of THE UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER (“UTMDACC”), a component institution of SYSTEM; (2) THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC. (“HJF”), a Maryland tax-exempt corporation, whose address is 1401 Rockville Pike, Suite 600, Rockville, Maryland 20852, on its own behalf and on behalf of THE UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES (“USU”), an institution of higher learning within the Department of Defense, an agency of the United States Government, located at 4301 Jones Bridge Road, Bethesda, Maryland 20814-4779; and (3) APTHERA, INC. (formerly known as ADVANCED PEPTIDE THERAPEUTICS, INC.; hereafter referred to as “LICENSEE”). BOARD, HJF and LICENSEE may be referred to herein collectively as the “PARTIES”.
RECITALS
A.   The LICENSE AGREEMENT requires LICENSEE to achieve certain performance milestones within a specified period of time.
 
B.   BOARD and HJF desire to provide LICENSEE with additional time in which to complete those performance milestones.
 
C.   Accordingly, BOARD, HJF and LICENSEE desire to amend the LICENSE AGREEMENT pursuant to the terms and conditions set forth herein.
     NOW, THEREFORE, in consideration of the mutual covenants contained herein, the sufficiency of which is hereby acknowledged, the PARTIES hereby agree to the following:

1


 

AMENDMENT
1.   Section 13.3(c) of the LICENSE AGREEMENT shall be deleted in its entirety and replaced with the following:
  13.3(c)    upon thirty (30) calendar days written notice from UTMDACC, if LICENSEE fails to commence a Phase II Clinical Trial or Phase III Clinical Trial in the United States or the European Union on or before June 30, 2010, unless, before the end of such thirty (30) day period, LICENSEE provides evidence satisfactory to UTMDACC that it has commenced the Clinical Trial; or
2.   Section 13.3(d) of the LICENSE AGREEMENT shall be deleted in its entirety and replaced with the following:
  13.3(d)    upon thirty (30) calendar days written notice from UTMDACC, if LICENSEE fails to acquire at least seven million dollars ($7,000,000.00) in funding (whether by debt, equity, merger, reverse merger, grant, corporate partnering or sublicensing) and provides evidence of same to UTMDACC on or before December 31, 2009; or
3.   The PARTIES acknowledge and agree that, except as set forth in this AMENDMENT NO. 3 the terms and conditions of the LICENSE AGREEMENT shall remain unchanged and in full force and effect; provided, however, that nothing contained in the LICENSE AGREEMENT shall have the effect of preventing or limiting, in any way, the terms of this AMENDMENT NO. 3. If any conflict arises between the terms of this AMENDMENT NO. 3 and the terms of the LICENSE AGREEMENT, this AMENDMENT NO. 3 shall govern as to the conflicting terms.
 
4.   This AMENDMENT NO. 3 shall be binding upon and inure to the benefit of the parties hereto and their respective heirs, administrators, executors, successors, and assigns.
 
5.   This AMENDMENT NO.3 may be executed in one or more counterparts, each of which shall be considered an original, but all of which together shall be deemed to be one and the same document.
[REMINDER OF PAGE INTENTIONALLY BLANK]

2


 

      IN WITNESS WHEREOF , the PARTIES hereto have caused their duly authorized representatives to execute this AMENDMENT NO 3.
             
BOARD OF REGENTS OF THE   APTHERA, INC.
UNIVERSITY OF TEXAS SYSTEM        
 
By  /s/ John Mendelsohn, M.D.   By  /s/ Robert E. Kennedy
  John Mendelsohn, M.D.     Name:  Robert E. Kennedy
  President     Title: President and CFO
  The University of Texas
M. D. Anderson Cancer Center

Date: 6/10/09
Date: 7/8/09
             
THE UNIVERSITY OF TEXAS   THE HENRY M. JACKSON FOUNDATION FOR
  M. D. ANDERSON CANCER CENTER   THE ADVANCEMENT OF MILITARY MEDICINE, INC.
 
By  /s/ Leon Leach   By  /s/ John W. Lowe
  Leon Leach     John W. Lowe
  Executive Vice President     President
  The University of Texas
M. D. Anderson Cancer Center

Date: 6/15/09
Date: 6/29/09
         
Approved as to Content:
 
 
By   /s/ Christopher C. Capelli        
  Christopher C. Capelli   
  Vice President, Technology Transfer
M. D. Anderson Cancer Center 
 
 
Date: 6/9/09

3

Exhibit 10.5
Text Marked By [* * *] Has Been Omitted Pursuant To A Request For Confidential Treatment And
Was Filed Separately With The Securities And Exchange Commission.
AMENDMENT NO. 4 TO THE
PATENT AND TECHNOLOGY LICENSE AGREEMENT
     This AMENDMENT NO. 4 to the Exclusive PATENT AND TECHNOLOGY LICENSE AGREEMENT between the PARTIES dated September 11, 2006, as amended on December 21, 2007, September 3, 2008, and again on July 8, 2009 (the “LICENSE AGREEMENT”), effective the 11th day of February, 2010 (which is the date this AMENDMENT NO. 4 has been fully executed by all PARTIES), is made by and between: (1) THE BOARD OF REGENTS (“BOARD”) of THE UNIVERSITY OF TEXAS SYSTEM (“SYSTEM”), an agency of the State of Texas, whose address is 201 West 7th Street, Austin, Texas 78701, on behalf of THE UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER (“UTMDACC”), a member institution of SYSTEM; (2) THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC. (“HJF”), a Maryland tax-exempt corporation, whose address is 1401 Rockville Pike, Suite 600, Rockville, Maryland 20852, on its own behalf and on behalf of THE UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES (“USU”), an institution of higher learning within the Department of Defense, an agency of the United States Government, located at 4301 Jones Bridge Road, Bethesda, Maryland 20814-4779; and (3) APTHERA, INC. (formerly known as ADVANCED PEPTIDE THERAPEUTICS, INC.; hereafter referred to as “LICENSEE”). BOARD, HJF and LICENSEE may be referred to herein collectively as the “PARTIES”.
RECITALS
A.   The LICENSE AGREEMENT requires LICENSEE to achieve certain performance milestones within a specified period of time and to pay Annual Maintenance Fees on a certain schedule.
B.   BOARD and HJF desire to provide LICENSEE with additional time in which to complete two of those performance milestones and to alter the Annual Maintenance Fee schedule.
C.   Accordingly, BOARD, HJF and LICENSEE desire to amend the LICENSE AGREEMENT pursuant to the terms and conditions set forth herein.

 


 

     NOW, THEREFORE, in consideration of the mutual covenants contained herein, the sufficiency of which is hereby acknowledged, the PARTIES hereby agree to the following:
AMENDMENT
1.   Section 4.1(d)(iii) of the LICENSE AGREEMENT shall be deleted in its entirety and replaced with the following:
    4.1(d)(iii)   [***] due without invoice within five (5) business days immediately after LICENSEE receives an aggregate of $500,000 of additional capital after December 4, 2009.
2.   A Section 4.8 shall be added to the Agreement as follows:
    During the term of the LICENSE AGREEMENT, UTMDACC’s Vice President, Technology Based Ventures or his/her designee (the “UTMDACC OBSERVER”) must be notified in writing at least ten (10) days in advance of all meetings of the LICENSEE’s Board of Directors (the “LICENSEE BOARD”), provided, however, that in the event the LICENSEE BOARD holds an emergency meeting as a result of any event or circumstance reasonably requiring or warranting a meeting of the LICENSEE BOARD on shorter notice, in which case the UTMDACC OBSERVER shall be notified of such emergency meeting at the same time as the members of the LICENSEE BOARD are notified, and such UTMDACC OBSERVER will have the right to observe in person or by teleconference all meetings of the LICENSEE BOARD and shall receive a copy of all materials provided to members of the LICENSEE BOARD at about the same time as such materials are distributed to the members of the LICENSEE BOARD, provided, however, that the UTMDACC OBSERVER shall maintain the confidentiality of all financial, confidential and proprietary information of the LICENSEE acquired as a result of his or her observation of such LICENSEE BOARD meetings.
3.   A Section 4.9 shall be added to the Agreement as follows:
    During the term of the LICENSE AGREEMENT, HJF’s Director, Technology Transfer & Commercialization or his/her designee (the “HJF OBSERVER”) must be notified in writing at least ten (10) days in advance of all meetings of the LICENSEE BOARD, provided, however, that in the event the LICENSEE BOARD holds an emergency meeting as a result of any event or circumstance reasonably requiring or warranting a meeting of the LICENSEE BOARD on shorter notice, in which case the HJF OBSERVER shall be notified of such emergency meeting at the same time as the members of the LICENSEE BOARD are notified, and such HJF OBSERVER will have the right to observe in person or

 


 

    by teleconference all meetings of the LICENSEE BOARD and shall receive a copy of all materials provided to members of the LICENSEE BOARD at about the same time as such materials are distributed to the members of the LICENSEE BOARD, provided, however, that the HJF OBSERVER shall maintain the confidentiality of all financial, confidential and proprietary information of the LICENSEE acquired as a result of his or her observation of such LICENSEE BOARD meetings.
4.   Section 13.3(c) of the LICENSE AGREEMENT shall be deleted in its entirety and replaced with the following:
  13.3   (c) upon thirty (30) calendar days written notice from UTMDACC, if LICENSEE fails to commence a Phase II Clinical Trial or Phase III Clinical Trial in the United States or the European Union on or before June 30, 2011, unless, before the end of such thirty (30) day period, LICENSEE provides evidence satisfactory to UTMDACC that it has commenced the Clinical Trial; or
5.   Section 13.3(d) of the LICENSE AGREEMENT shall be deleted in its entirety and replaced with the following:
  13.3   (d) upon thirty (30) calendar days written notice from UTMDACC, if LICENSEE fails to acquire at least four million dollars ($4,000,000.00) in funding (whether by debt, equity, merger, reverse merger, grant, corporate partnering or sublicensing) and provides evidence of same to UTMDACC on or before July 31, 2010; or
6.   LICENSEE shall pay UTMDACC an Amendment Fee (in consideration for UTMDACC and HJF allowing the Amendment) of [***] without invoice within fifteen (15) calendar days of the date this AMENDMENT NO. 4 is fully executed by all PARTIES.
7.   The PARTIES acknowledge and agree that, except as set forth in this AMENDMENT NO. 4 the terms and conditions of the LICENSE AGREEMENT shall remain unchanged and in full force and effect; provided, however, that nothing contained in the LICENSE AGREEMENT shall have the effect of preventing or limiting, in any way, the terms of this AMENDMENT NO. 4. If any conflict arises between the terms of this AMENDMENT NO. 4 and the terms of the LICENSE AGREEMENT, this AMENDMENT NO. 4 shall govern as to the conflicting terms.

 


 

8.   This AMENDMENT NO. 4 shall be binding upon and inure to the benefit of the parties hereto and their respective heirs, administrators, executors, successors, and assigns.

 


 

      IN WITNESS WHEREOF , the PARTIES hereto have caused their duly authorized representatives to execute this AMENDMENT NO 4.
                     
BOARD OF REGENTS OF THE     APTHERA, INC.    
UNIVERSITY OF TEXAS SYSTEM                
 
                   
By
  /s/ John Mendelsohn, M.D.
 
      By   /s/ Robert E. Kennedy
 
   
 
  John Mendelsohn, M.D.           Name: Robert E. Kennedy    
 
  President           Title: President and CFO    
 
  The University of Texas                
 
  M. D. Anderson Cancer Center                
 
Date: 2/11/09       Date: 2/1/10    
 
                   
THE UNIVERSITY OF TEXAS

     
THE HENRY M. JACKSON FOUNDATION FOR
       
M. D. ANDERSON CANCER CENTER       THE ADVANCEMENT OF MILITARY MEDICINE, INC.    
 
                   
By
  /s/ Leon Leach
 
Leon Leach
      By   /s/ John W. Lowe
 
John W. Lowe
   
 
  Executive Vice President           President    
 
  The University of Texas                
 
  M. D. Anderson Cancer Center       Date: 2/2/10    
 
                   
Date: 2/10/10            
 
                   
Approved as to Content:                
 
                   
By
  /s/ Christopher C. Capelli                
 
                   
 
  Christopher C. Capelli                
 
  Vice President, Technology Transfer                
 
  M. D. Anderson Cancer Center                
 
                   
Date: 2/5/10                

 

Exhibit 10.6
Text Marked By [* * *] Has Been Omitted Pursuant To A Request For Confidential Treatment And
Was Filed Separately With The Securities And Exchange Commission.
AMENDMENT NO. 5 TO THE
PATENT AND TECHNOLOGY LICENSE AGREEMENT
     This AMENDMENT NO. 5 to the PATENT AND TECHNOLOGY LICENSE AGREEMENT between the PARTIES dated September 11, 2006, as amended on December 21, 2007, September 3, 2008, July 8, 2009, and February 11, 2010 (the “LICENSE AGREEMENT”), effective the 10th day of January, 2011 (“AMENDMENT NO. 5 EFFECTIVE DATE”, which is the date this AMENDMENT NO. 5 has been fully executed by all PARTIES), is made by and between: (1) THE BOARD OF REGENTS (“BOARD”) of THE UNIVERSITY OF TEXAS SYSTEM (“SYSTEM”), an agency of the State of Texas, whose address is 201 West 7th Street, Austin, Texas 78701, on behalf of THE UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER (“UTMDACC”), a member institution of SYSTEM; (2) THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC. (“HJF”), a Maryland tax-exempt corporation, whose address is 1401 Rockville Pike, Suite 600, Rockville, Maryland 20852, on its own behalf and on behalf of THE UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES (“USU”), an institution of higher learning within the Department of Defense, an agency of the United States Government, located at 4301 Jones Bridge Road, Bethesda, Maryland 20814-4779; and (3) APTHERA, INC. (formerly known as ADVANCED PEPTIDE THERAPEUTICS, INC.; hereafter referred to as “LICENSEE”). BOARD, HJF and LICENSEE may be referred to herein collectively as the “PARTIES.”
RECITALS
A.   The LICENSE AGREEMENT requires LICENSEE to achieve certain performance milestones and funding requirements within a specified period of time and to pay annual maintenance fees and/or running royalties on a certain schedule.
 
B.   LICENSEE seeks additional time in which to complete certain required milestones and obtain funding as referenced herein and also seeks to alter the annual maintenance fee schedule and annual minimum royalty schedule. BOARD and HJF wish to allow LICENSEE additional time to complete such milestones and obtain such funding. BOARD and HJF are also willing to alter the annual maintenance fee schedule and royalty schedule. BOARD and HJF accordingly agree to modify the LICENSE AGREEMENT as set forth herein rather than terminate the LICENSE AGREEMENT or assert a breach of the

1


 

    LICENSE AGREEMENT based upon LICENSEE’s past noncompliance with the milestones, funding obligations, or payment schedules referenced herein.
C.   Accordingly, BOARD, HJF and LICENSEE desire to amend the LICENSE AGREEMENT pursuant to the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the mutual covenants contained herein, the sufficiency of which is hereby acknowledged, the PARTIES hereby agree to the following:
AMENDMENT
1.   A new Section 2.17 is hereby added to the LICENSE AGREEMENT as follows:
  2.17   FINANCING means either (a) a financing in connection with a reverse merger into an existing public company immediately after which LICENSEE’s shareholders own a majority of the outstanding shares and LICENSEE’s management is the surviving management of the merged company; or (b) other financing or financings when in combination with or in lieu of the reverse merger, including, but not limited to, debt, convertible debt, private equity, and grants; provided that such financing(s) in the case of either (a) or (b) will net LICENSEE a minimum aggregate funding of $2.0 million.
2.   A new section 2.18 is hereby added to the LICENSE AGREEMENT as follows:
  2.18   EXCLUSIVE MARKETING RIGHTS means exclusive rights granted by the U.S. government to market (a) a drug for a rare disease or condition (“Orphan Drug”) pursuant to the U.S. FDA Code of Federal Regulations, Title 21, Chapter I, Subchapter D, Part 316 (entitled “Orphan Drugs”), enacted pursuant to 21 U.S.C. Part B (entitled “Drugs for Rare Diseases or Conditions”), as may be amended or modified, and/or (b) a biological drug pursuant to the Biologics Price Competition and Innovation Act of 2009, 42 U.S.C. § 262(k)(7)(A).
3.   A new section 2.19 is hereby added to the LICENSE AGREEMENT as follows:

2


 

  2.19   CLINICAL DEADLINE means the date that is fifteen (15) months from the date of the completion of the FINANCING.
4.   A new section 2.20 is hereby added to the LICENSE AGREEMENT as follows:
  2.20   REGISTRATION CLINICAL TRIAL means a late-stage clinical trial such as a PHASE III CLINICAL TRIAL or PHASE II/III CLINICAL TRIAL intended for the purpose of supporting an NDA.
5.   Section 4.1(d)(iii) of the LICENSE AGREEMENT shall be deleted in its entirety and replaced with the following:
      4.1(d)(iii) (A) [***] due within ten (10) calendar days after the AMENDMENT NO. 5 EFFECTIVE DATE, and (B) [***] due in quarterly payments of [***] beginning on the date that is sixty (60) calendar days following completion of the FINANCING and every ninety (90) calendar days thereafter. In the event that LICENSEE raises a net $6 million or more in the FINANCING, the quarterly payments due under Section 4.1(d)(iii)(B) shall become due and payable within ten (10) calendar days of raising such funds;
6.   Section 4.1(d)(iv) of the LICENSE AGREEMENT shall be deleted in its entirety and replaced with the following:
      4.1(d)(iv) [***] due on or before August 1, 2011; and
7.   Section 4.1(d)(v) of the LICENSE AGREEMENT shall be deleted in its entirety and replaced with the following:
      4.1(d)(v) [***] due on or before August 1, 2012; and
8.   Section 4.1(e) of the LICENSE AGREEMENT shall be deleted in its entirety and replaced with the following:
      4.1(e) Beginning on September 30, 2012, LICENSEE shall pay UTMDACC, on a quarterly basis (with a quarterly payment due on September 30, 2012), the greater of: (i)

3


 

      an annual minimum royalty of [***] (payable in four equal quarterly installments of [***] each); or (ii) a running royalty (payable quarterly as set forth in Section 4.3, below) which shall be equal to the combined total of all of the following running royalties:
 
  (i)   as to NET SALES of LICENSED PRODUCTS in a given jurisdiction covered by at least one VALID CLAIM existing in such jurisdiction at the time of the relevant SALE: (1) [***] % of the first [***] of such NET SALES; (2) [***] % of the second [***] of such NET SALES; and (3) [***] % of all such NET SALES in excess of [***] ; and
 
  (ii)   as to NET SALES of any LICENSED PRODUCT in a given jurisdiction not covered by any VALID CLAIM existing in such jurisdiction at the time of the relevant SALE: (1) [***] % of the first [***] of such NET SALES; (2) [***] % of the second [***] of such NET SALES, and (3) [***] % of all such NET SALES in excess of [***] ; and
9.   Section 4.1(f) shall be deleted in its entirety and replaced with the following:
      4.1(f) The following one-time milestone payments:
     
Milestone   Milestone Payment
(i) Commencement of PHASE III CLINICAL TRIAL for a LICENSED PRODUCT
  [***]
 
   
(ii) Filing of an NDA for a LICENSED PRODUCT
  [***]
 
   
(iii) MARKETING APPROVAL of a LICENSED PRODUCT
  [***]
 
   
(iv) First SALE of a LICENSED PRODUCT
  [***]
 
   
(v) Completion of FINANCING
  [***]

4


 

      For purposes hereof, “Commencement” means administration of the first dose to a human. The milestone payment set forth in subsection 4.1(f)(v) shall be paid by LICENSEE within ten (10) calendar days of the completion of FINANCING regardless of whether any or all other milestones have been met; all other of the foregoing milestone payments in Sections 4.1(f)(i)—(iv) shall be made by LICENSEE to UTMDACC within thirty (30) calendar days of achieving the milestone event. The milestone payments in this Section 4.1(f) shall [***] reduce the amount of any other payment provided for in this ARTICLE IV; and
10.   A new section 4.10 is hereby added to the LICENSE AGREEMENT as follows:
  4.10   The parties shall have no obligations under Section 4.8 and Section 4.9 hereof after the completion of the FINANCING.
11.   Section 13.1 shall be deleted in its entirety and replaced with the following:
  13.1   Subject to Sections 13.2, 13.3, and 13.4 hereinbelow, the term of this AGREEMENT is from the EFFECTIVE DATE to the longer of (a) five (5) years from the date upon which all PATENT RIGHTS have expired, or all claims in the PATENT RIGHTS have been declared invalid or unenforceable by a court or tribunal in a final decision not subject to further appeal, or have been abandoned, or (b) the date upon which EXCLUSIVE MARKETING RIGHTS for a LICENSED PRODUCT have expired; provided, however, that if EXCLUSIVE MARKETING RIGHTS for a LICENSED PRODUCT are not in existence on the date set forth in (a) above, then the term shall expire on the date set forth in (a) above.
12.   Section 13.3(c) is deleted in its entirety and is replaced with the following:
  13.3 (c)   Upon forty-five (45) calendar days written notice from UTMDACC, if LICENSEE fails to initiate a REGISTRATION CLINICAL TRIAL in the intended patient population of node positive, HER2 1+ and/or 2+ breast cancer in the United States, the European Union, Eastern Europe, Japan, India, China, or other

5


 

      country(ies) as may be mutually agreed by all of the parties hereto on or before the CLINICAL DEADLINE, unless before the end of such forty-five (45) calendar day period, LICENSEE provides evidence satisfactory to UTMDACC that it has initiated the REGISTRATION CLINICAL TRIAL. For the avoidance of doubt, LICENSEE must initiate a REGISTRATION CLINICAL TRIAL on or before the CLINICAL DEADLINE unless specifically requested or demanded otherwise by a strategic collaborative partner (identified by LICENSEE in writing to UTMDACC) or the U.S. FDA or equivalent foreign regulatory agency, and LICENSEE’s failure to so initiate a REGISTRATION CLINICAL TRIAL in the absence of such request or demand shall be a basis for termination of this AGREEMENT. LICENSEE may extend the CLINICAL DEADLINE as follows:
  i.   At the election of the LICENSEE, prior to the CLINICAL DEADLINE LICENSEE may pay to UTMDACC a [***] extension fee (the “Option 1 Fee”) and receive a six (6) month extension of the CLINICAL DEADLINE (as extended, the “Option 1 Clinical Trial Date”);
 
  ii.   Upon LICENSEE’s timely payment of the Option 1 Fee and upon the mutual agreement of the parties, prior to the Option 1 Clinical Trial Date LICENSEE may pay to UTMDACC a [***] extension fee (the “Option 2 Fee”) and receive a second six (6) month extension of the Option 1 Clinical Trial Date (as extended, the “Option 2 Clinical Trial Date”);
 
  iii.   Upon LICENSEE’s timely payments of the Option 1 Fee and the Option 2 Fee and upon the mutual agreement of the parties, prior to the Option 2 Clinical Trial Date LICENSEE may pay to UTMDACC a [***] extension fee (the “Option 3 Fee”) and receive a third six (6) month extension of the Option 2 Clinical Trial Date (as extended, the “Option 3 Clinical Trial Date”); or

6


 

13.   Section 13.3(d) of the LICENSE AGREEMENT shall be deleted in its entirety and replaced with the following:
     
 
  13.3 (d):   upon thirty (30) calendar days written notice from UTMDACC if LICENSEE fails to complete a FINANCING and provide evidence of the same to UTMDACC within six (6) months of the AMENDMENT NO. 5 EFFECTIVE DATE; or
14.   A new section 13.5 is hereby added to the LICENSE AGREEMENT as follows:
  13.5   In the event the AGREEMENT is terminated prior to commencement of marketing of any LICENSED PRODUCT due to LICENSEE’s default, the parties agree that all assets related to an investigational new drug, NDA, efforts to obtain MARKETING APPROVAL, or any clinical trial program (i.e., scientific data, clinical trial study documents and results, workbooks and laboratory reports and results, etc.) shall become the property of UTMDACC and HJF. In the event UTMDACC and HJF wish to acquire bulk active, work in process or finished good inventory from LICENSEE related to one or more LICENSED PRODUCTS, LICENSEE agrees to negotiate in good faith for a fair market price to sell such inventory.
15.   LICENSEE shall pay UTMDACC an amendment fee (in consideration for UTMDACC and HJF allowing this amendment) of [***] within fifteen (15) calendar days after the AMENDMENT NO. 5 EFFECTIVE DATE.
16.   Immediately prior to the close of the FINANCING, (a) LICENSEE shall purchase one hundred percent (100%) of UTMDACC’s common shares of LICENSEE [***] for [***] paid to UTMDACC; and (b) LICENSEE shall purchase one hundred percent (100%) of HJF’s common shares of LICENSEE [***] for [***] paid to HJF. UTMDACC and HJF agree that the payments for shares received from LICENSEE under this Section 16 of AMENDMENT NO. 5 shall not be subject to distribution as LICENSE REVENUE under Section 6.2 of the Inter-Institutional Sharing Agreement dated February 9, 2006 between UTMDACC and HJF.

7


 

17.   LICENSEE shall pay UTMDACC all outstanding patent expenses incurred by UTMDACC as of the AMENDMENT NO. 5 EFFECTIVE DATE (in the amount of [***] ) within ten (10) calendar days after the AMENDMENT NO. 5 EFFECTIVE DATE. LICENSEE’s obligations with respect to the payment of patent expenses set forth in the LICENSE AGREEMENT (including, for example, obligations in Sections 4.1(a) and 6.1) shall remain in effect and are not otherwise amended hereby.
 
18.   The PARTIES acknowledge and agree that, except as set forth in this AMENDMENT NO. 5, the terms and conditions of the LICENSE AGREEMENT shall remain unchanged and in full force and effect; provided, however, that nothing contained in the LICENSE AGREEMENT shall have the effect of preventing or limiting, in any way, the terms of this AMENDMENT NO. 5. If any conflict arises between the terms of this AMENDMENT NO. 5 and the terms of the LICENSE AGREEMENT, this AMENDMENT NO. 5 shall govern as to the conflicting terms.
 
19.   This AMENDMENT NO. 5 shall be binding upon and inure to the benefit of the PARTIES hereto and their respective heirs, administrators, executors, successors, and assigns.

8


 

      IN WITNESS WHEREOF , the PARTIES hereto have caused their duly authorized representatives to execute this AMENDMENT NO 5.
                     
BOARD OF REGENTS OF THE       APTHERA, INC.    
UNIVERSITY OF TEXAS SYSTEM                
 
                   
By
  /s/ John Mendelsohn, M.D.       By   /s/ Robert E. Kennedy    
 
 
 
         
 
   
 
  John Mendelsohn, M.D.           Name: Robert E. Kennedy    
 
  President           Title: President and CFO    
 
  The University of Texas                
 
  M. D. Anderson Cancer Center                
 
Date: 1/10/11       Date: 12/18/10    
 
                   
THE UNIVERSITY OF TEXAS                
M. D. ANDERSON CANCER CENTER       THE HENRY M. JACKSON FOUNDATION    

By
 
/s/ Leon Leach
      FOR THE ADVANCEMENT OF
MILITARY MEDICINE, INC.
   
 
                   
 
  Leon Leach
Executive Vice President
     
By
 
/s/ John W. Lowe
   
 
                   
 
  The University of Texas           John W. Lowe    
 
  M. D. Anderson Cancer Center           President    
 
                   
Date: 1/5/11       Date: 12/20/10    
 
                   
Approved as to Content:                
 
                   
By
  /s/ Christopher C. Capelli
 
Christopher C. Capelli
               
 
  Vice President, Technology Transfer                
 
  M. D. Anderson Cancer Center                
 
                   
Date: 12/21/10                

9

Exhibit 10.8
Execution Version
EMPLOYMENT AGREEMENT
     The Employment Agreement (the “ Agreement ”) is made and entered into as of April 13, 2011 (the “ Effective Date ”) by and between RXi Pharmaceuticals Corporation, a Delaware corporation (the “ Company ”, or “ Employer ”), and Mark W. Schwartz, Ph.D., an individual and resident of the State of California (“ Employee ”).
     WHEREAS, Employer and Employee desire to enter into an employment agreement under which Employee shall serve on a full-time basis as the Company’s Executive Vice President and Chief Operating Officer on the terms set forth in the Agreement, with the term of the Agreement to commence on the Effective Date.
     NOW, THEREFORE, upon the above premises, and in consideration of the mutual covenants and agreements hereinafter contained, the parties hereto agree as follows.
     1.  Engagement . Effective as of the Effective Date, Employer shall employ Employee, and Employee shall serve, as the Company’s Executive Vice President and Chief Operating Officer. Employee understands that his duties as Executive Vice President and Chief Operating Officer may change from time to time during the Term (as herewith defined) in the discretion of Employer’s Board of Directors (hereinafter the “ Board ”), but such duties shall in all events be at least consistent with the duties customarily assigned to the Executive Vice President and Chief Operating Officer of a company substantially comparable as of the Effective Date to Employer. As a condition to the Employee’s employment by the Employer, Employee and Employer shall execute the Employee Confidentiality, Non-Competition, and Proprietary Information Agreement, attached hereto as Exhibit 1 (the “ Confidentiality Agreement ”).
     2.  Duties . Employee shall perform all duties assigned to him in accordance with the terms of this Agreement by the Board faithfully, diligently and to the best of his ability. Such duties include, without limitation, the overseeing and implementation of the business plan adopted by the Board (as may be revised from time to time by the Board). Employee shall perform the services contemplated under this Agreement in accordance with the policies established by and under the direction of the Board. Employee shall have such corporate power and authority as shall reasonably be required to enable him to discharge his duties under this Agreement. Employee’s services hereunder shall be rendered at Employee’s home office in Danville, CA (or such other location consistent with Employee’s residence), except for travel when and as required in the performance of Employee’s duties hereunder.
     3.  Time and Efforts . Employee shall devote all of his business time, efforts, attention and energies to Employer’s business and the discharge of his duties hereunder. Notwithstanding the foregoing, except as otherwise agreed to in writing, Employee shall have the right to perform such incidental services as are necessary in connection with (a) his private passive investments, (b) his charitable or community activities, (c) his participation in trade or professional organizations and (d) his service on the board of directors (or comparable body) of one third-party corporate entity that does not compete with the Company Business (as defined in the Confidentiality Agreement), and teaching responsibilities of one class per semester at San Jose State University, consistent with past responsibilities at the University.
         
Employment Agreement        
Mark W. Schwartz, Ph.D.   Page 1 of 7    

 


 

     4.  Term . Employee’s employment shall commence on the Effective Date and shall terminate on April 13, 2012 (the “ Term ”), unless sooner terminated in accordance with Section 6. Neither Employer nor Employee shall have any obligation to extend or renew this Agreement or Employee’s employment. Unless the parties otherwise agree in writing, Employee’s employment by Employer shall terminate upon any termination or expiration of this Agreement.
     5.  Compensation . As the total consideration for Employee’s services rendered under the Agreement, Employer shall pay or provide Employee the following compensation and benefits:
          5.1. Salary . Employee shall initially be entitled to receive an annual base salary during the Term of Two Hundred Twenty Five Thousand Dollars ($225,000) (hereinafter the “ Base Salary ”) payable in accordance with the usual payroll period of Employer, as established from time to time. If and when during the Term the Company completes one or more financing transactions (including the transaction currently being undertaken in conjunction with Roth) in which it sells shares of its capital stock (or securities convertible into or exercisable or exchangeable for its capital stock) (each, a “ Financing ,” and collectively, the “ Financings ”) resulting in aggregate gross cash proceeds of at least $5.0 million, then the Base Salary shall be increased to Two Hundred Seventy Five Thousand Dollars ($275,000) per annum. Further, if and when during the Term the Company completes one or more Financings resulting in aggregate gross cash proceeds of at least $10.0 million, then the Base Salary shall be increased to Three Hundred Thousand Dollars ($300,000) per annum. For purposes of this Agreement, a Financing shall not include any proceeds to the Company resulting from the sale of Company capital stock pursuant to the exercise of stock options or other issuances made primarily for compensatory purposes, or pursuant to the exercise of warrants or other rights to purchase capital stock of the Company outstanding as of the Effective Date.
          5.2 Stock Option . On the Effective Date, the Company shall grant Employee a stock option (“ Option ”) under the Company’s Amended and Restated 2007 Incentive Plan (the “ Plan ”) to purchase Forty Thousand (40,000) shares of the Company’s common stock. Except as provided in Section 6.2 of this Agreement, the Option shall vest in equal quarterly installments over 3 years beginning on the first quarterly anniversary of the Effective Date, provided, in each case, that Employee remains in the continuous employ of Employer through such quarterly anniversary date. The Option shall (a) be exercisable at an exercise price per share equal to the closing market price of the Company’s common stock on the date of the grant, (b) have a term of ten years, and (c) be on such other terms as shall be determined by the Board (or the Compensation Committee of the Board) and set forth in a customary form of stock option agreement under the Plan evidencing the Option.
          5.3. Expense Reimbursement . Employer shall reimburse Employee for reasonable business expenses incurred by Employee in connection with the performance of Employee’s duties in accordance with Employer’s usual practices and policies in effect from time to time. Employer will reimburse reasonable and customary expenses for the Employee to maintain his home office. Any reimbursements hereunder shall be paid to Employee promptly in a lump sum in accordance with such expense reimbursement policies and procedures then in effect.
         
Employment Agreement        
Mark W. Schwartz, Ph.D.   Page 2 of 7    

 


 

          5.4. Vacation . Employee will be entitled to four weeks of paid “time off” (vacation days plus sick time/personal time) for each full calendar year in accordance with the Company’s policies from time to time in effect, in addition to holidays observed by the Company (for partial calendar years, the Employee’s paid “time off” will be pro-rated). Paid time off may be taken at such times and intervals as the Employee shall determine, subject to the business needs of the Company, and otherwise shall be subject to the policies of the Company, as in effect from time to time. The number of paid “time off” days will accrue per pay period and will stop accruing once 20 days have been reached.
          5.5. Employee Benefits . The Company shall provide Employee and his dependents with coverage under all medical, dental and/or vision plans and other benefit programs available to the Company’s executives and their dependents, to the extent Employee and his dependents satisfy the applicable eligibility requirements, and the Company shall pay, directly or indirectly, the monthly and annual premiums associated with any such medical plans to the same extent the Company pays such premiums for other executives of the Company. Employee shall be eligible to participate in any medical insurance and other employee benefits made available by Employer to all senior executives and/or all of employees of Employer under Employer’s plans and employment policies in effect during the Term. Employee acknowledges and agrees that, any such plans or policies now or hereafter in effect may be modified or terminated by Employer at any time in its discretion.
          5.6. Payroll Taxes . Employer shall have the right to deduct from the compensation and benefits due to Employee hereunder any and all sums required for social security and withholding taxes and for any other federal, state, or local tax or charge which may be in effect or hereafter enacted or required as a charge on the compensation or benefits of Employee.
     6.  Termination . The Agreement and Employee’s employment may be terminated as set forth in this Section 6.
          6.1. Termination by Employer for Cause; Termination by Employee . Employer may terminate Employee’s employment hereunder for Cause upon notice to Employee, and Employee may terminate his employment hereunder, for any reason or no reason, upon notice to Employer. Cause for the purpose of this Agreement shall mean any of the following:
          (a) Employee’s breach of any material term of this Agreement including its Exhibits; provided that the first occasion of any particular breach shall not constitute Cause unless Employee shall have previously received written notice from Employer stating the nature of such breach and affording Employee at least ten (10) days to correct such breach;
          (b) Employee’s conviction of, or plea of guilty or nolo contendere to, any felony or other crime of moral turpitude;
          (c) Employee’s act of fraud or dishonesty injurious to Employer or its reputation;
         
Employment Agreement        
Mark W. Schwartz, Ph.D.   Page 3 of 7    

 


 

          (d) Employee’s continual failure or refusal to perform his material duties as required under the Agreement after written notice from Employer stating the nature of such failure or refusal and affording Employee at least ten days to correct the same;
          (e) Employee’s act or omission that, in the reasonable determination of Employer’s Board (or a Committee of the Board), indicates alcohol or drug abuse by Employee; or
          (f) Employee’s act or personal conduct that, in the judgment of the Board (or a Committee of the Board), gives rise to a material risk of liability of Employee or Employer under federal or applicable state law for discrimination, or sexual or other forms of harassment, or other similar liabilities to subordinate employees.
          Upon termination of Employee’s employment by Employer for Cause or by Employee for any reason, all compensation and benefits to Employee hereunder shall cease except that Employee shall be entitled to payment, not later than three days after the date of termination, of (i) any accrued but unpaid salary and unused vacation time (only as accrued during the then-current year of employment), and (ii) reimbursement of business expenses accrued but unpaid as of the date of termination. In addition, Employer’s indemnification obligations shall remain in effect in accordance with the terms thereof.
          6.2. Termination by Employer without Cause . Employer may also terminate Employee’s employment without Cause during the Term; provided, however, that (i) Employer shall remain obligated to continue paying Employee’s Base Salary at the time of termination for the remainder of the Term, and (ii) Employee’s Option shall continue to vest for the remainder of the Term. Upon any termination pursuant to this paragraph, Employee shall, not later than three days after the date of termination, be entitled to payment of any unused vacation time (only as accrued as of the date of such termination and in accordance with applicable law) and reimbursement of business expenses accrued but unpaid as of the date of termination.
          Change of Control — If in the change of control of the company, the compensation, benefits, title, or duties of the Employee under this agreement are reduced, or the Employee must relocate more then 50 miles from his current residence, the Employee is considered Terminated without Cause, with all of the benefits and payments due Employee as detailed in Section 6.2 of this Employment Agreement.
     7.  Equitable Remedies; Injunctive Relief . Employee hereby acknowledges and agrees that monetary damages are inadequate to fully compensate Employer for the damages that would result from a breach or threatened breach of the Confidentiality Agreement and, accordingly, that Employer shall be entitled to equitable remedies, including, without limitation, specific performance, temporary restraining orders, and preliminary injunctions and permanent injunctions, to enforce such Section without the necessity of proving actual damages in connection therewith. The provision shall not, however, diminish Employer’s right to claim and recover damages or enforce any other of its legal or equitable rights or defenses.
         
Employment Agreement        
Mark W. Schwartz, Ph.D.   Page 4 of 7    

 


 

     8.  Indemnification . Employer and Employee acknowledge that, as the Executive Vice President and Chief Operating Officer of Employer, Employee shall be a corporate officer of Employer and, as such, Employee shall be entitled to indemnification to the full extent mandated by Employer to its officers, directors and agents under the Employer’s Certificate of Incorporation and Bylaws as in effect as of the date of this Agreement.
     9.  Severable Provisions . The provisions of this Agreement are severable and if any one or more provisions is determined to be illegal or otherwise unenforceable, in whole or in part, the remaining provisions, and any partially unenforceable provisions to the extent enforceable, shall nevertheless be binding and enforceable.
     10.  Successors and Assigns . This Agreement shall inure to the benefit of and shall be binding upon and enforceable by Employer, its successors and assigns and Employee and his heirs and representatives; provided, however, that neither party may assign the Agreement without the prior written consent of the other party. Employer will cause any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of Employer to assume expressly and agree to perform this Agreement in the same manner and to the same extent that Employer would have been required to perform it.
     11.  Entire Agreement . This Agreement, including the Confidentiality Agreement, contains the entire agreement of the parties relating to the subject matter hereof, and the parties hereto have made no agreements, representations or warranties relating to the subject matter of the Agreement that are not set forth otherwise therein or herein. Except as expressly provided herein, this Agreement (including the Confidentiality Agreement) supersedes any and all prior or contemporaneous agreements, written or oral, between Employee and Employer relating to the subject matter hereof. Any such prior or contemporaneous agreements, as well as that certain Employment Agreement between Employee and Apthera, Inc. (“ Apthera ”) dated April 1, 2010, as amended on July 1, 2010 (the “ Prior Agreement ”), are hereby terminated and of no further effect, and Employee, by the execution hereof, agrees that any compensation provided for under any such agreements is specifically superseded and replaced by the provisions of this Agreement (including the Confidentiality Agreement). Employee acknowledges that all compensation and other obligations owed to Employee by Apthera pursuant to the Prior Agreement have been fully and finally paid and satisfied as of the Effective Date.
     12.  Amendment . No modification of this Agreement shall be valid unless made in writing, approved by the Employer’s Board (or a committee of the Board) and signed by the parties hereto and unless such writing is made by an executive officer of Employer (other than Employee). The parties hereto agree that in no event shall an oral modification of this Agreement be enforceable or valid.
     13.  Governing Law; Arbitration . This Agreement is and shall be governed and construed in accordance with the laws of the State of Delaware without giving effect to the choice-of-law rules of Delaware. Except to the extent a remedy is sought as described in Section 7, above, any dispute arising out of, or relating to, this Agreement or the breach thereof, or regarding the interpretation thereof, shall be exclusively decided by binding arbitration
         
Employment Agreement        
Mark W. Schwartz, Ph.D.   Page 5 of 7    

 


 

conducted in Los Angeles, California in accordance with the rules of the American Arbitration Association (the “AAA”) then in effect before a single arbitrator appointed in accordance with such rules. Judgment upon any award rendered therein may be entered and enforcement obtained thereon in any court having jurisdiction. Each of the parties agrees that service of process in such arbitration proceedings shall be satisfactorily made upon it if sent by registered mail addressed to it at the address referred to in Section 14 below. The costs of such arbitration shall be borne proportionate to the finding of fault as determined by the arbitrator. Judgment on the arbitration award may be entered by any court of competent jurisdiction.
     14.  Notice . All notices and other communications under this Agreement shall be in writing and mailed, electronically mailed, telecopied (in case of notice to Employer only) or delivered by hand or by a nationally recognized courier service guaranteeing overnight delivery to a party at the following address (or to such other address as such party may have specified by notice given to the other party pursuant to the provision):
If to Employer:
RXi Pharmaceuticals Corporation
60 Prescott St.
Worcester, MA 01605
Attention: Chief Executive Officer
Fax: (508) 767-3862
Email: mahn@rxipharma.com
If to Employee:
Through company e-mail or company regular mail box if employed by Company or if not employed:
Mark W. Schwartz, Ph.D.
305 Love Lane
Danville, CA 94526
Email: mwschwartz@yahoo.com
     15.  Survival . Sections 7 through 16 shall survive the expiration or termination of the Agreement.
     16.  Counterparts . The Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which together shall be deemed to be one and the same agreement.
     18.  Attorney’s Fees . In any action or proceeding to construe or enforce any provision of the Agreement the prevailing party shall be entitled to recover its or his reasonable attorneys’ fees and other costs of suit in addition to any other recoveries.
         
Employment Agreement        
Mark W. Schwartz, Ph.D.   Page 6 of 7    

 


 

IN WITNESS WHEREOF, the Agreement is executed as of the day and year first above written.
         
  EMPLOYER

RXi Pharmaceuticals Corporation

 
 
  By:   /s/ Mark J. Ahn    
    Name:   Mark J. Ahn, Ph.D.   
    Its: President & Chief Executive Officer    
 
  EMPLOYEE
 
 
  /s/ Mark W. Schwartz    
  Mark W. Schwartz, Ph.D.   
     
 
         
Employment Agreement        
Mark W. Schwartz, Ph.D.   Page 7 of 7    

 


 

Exhibit 1
RXi Pharmaceuticals Corporation
EMPLOYEE CONFIDENTIALITY, NON-COMPETITION, AND
PROPRIETARY INFORMATION AGREEMENT
     AGREEMENT, effective as of April 13, 2011, between RXi Pharmaceuticals Corporation, a Delaware corporation (the “Company”), and Mark W. Schwartz, Ph.D. (the “Employee”).
     1. Employee will make full and prompt disclosure to the Company of all inventions, improvements, modifications, discoveries, methods, technologies, biological materials, and developments, and all other materials, items, techniques, and ideas related directly or indirectly to the business of the Company, whether patentable or not, made or conceived by Employee or under Employee’s direction during Employee’s employment with the Company, whether or not made or conceived during normal working hours, or on the premises of the Company (all of which are collectively termed “Intellectual Property” hereinafter).
     2. Employee agrees that all Intellectual Property, as defined above, shall be the sole property of the Company and its assigns, and the Company and its assigns shall be the sole owner of all patents and other rights in connection therewith. Employee hereby assigns to the Company any rights Employee may have or acquire in all Intellectual Property and all related patents, copyrights, trademarks, trade names, and other industrial and intellectual property rights and applications therefore, in the United States and elsewhere. Employee further agrees that with regard to all future developments of Intellectual Property, Employee will assist the Company in every way that may be reasonably required by the Company (and at the Company’s expense) to obtain and, from time to time, enforce patents on Intellectual Property in any and all countries that the Company may require, and to that end, Employee will execute all documents reasonably necessary for use in applying for and obtaining such patents thereon and enforcing the same, as the Company may desire, together with any assignment thereof to the Company or persons designated by the Company, and Employee hereby appoints the Company as Employee’s attorney to execute and deliver any such documents or assignments requested by the Company (but only for the purpose of executing and filing any such document). Employee’s obligation to assist the Company in obtaining and enforcing patents for Intellectual Property in any and all countries shall continue beyond the termination of Employee’s employment with the Company, but the Company shall compensate Employee at a reasonable, standard hourly rate following such termination for time directly spent by Employee at the Company’s request for such assistance.
     3. Employee hereby represents that Employee has no continuing obligation to assign to any former employer or any other person, corporation, institution, or firm any Intellectual Property as described above. Employee represents that Employee’s performance of all the terms of this Agreement and as an employee of the Company does not and will not breach any agreement to keep in confidence proprietary information acquired by Employee, in confidence or in trust, prior to Employee’s employment by the Company. Employee has not entered into, and Employee agrees not to enter into, any agreement (either written or oral), which would put Employee in conflict with this Agreement.
         
Exhibit 1        
Mark W. Schwartz, Ph.D.   Page 1 of 6    

 


 

     4. Employee agrees to assign to the Company any and all copyrights and reproduction rights to any material prepared by Employee in connection with this Agreement and/or developed by Employee during Employee’s employment with the Company that are related directly or indirectly to the business of the Company.
     5. Employee understands and agrees that a condition of Employee’s employment and continued employment with the Company is that Employee has not brought and will not bring to the Company or use in the performance of Employee’s duties at the Company any materials or documents rightfully belonging to a former employer which are not generally available to the public.
     6. Employee recognizes that the services to be performed by Employee hereunder are special, unique, and extraordinary and that, by reason of Employee’s employment with the Company, Employee may acquire Confidential Information (as hereinafter defined) concerning the operation of the Company, the use or disclosure of which would cause the Company substantial loss and damage which could not be readily calculated and for which no remedy at law would be adequate. Accordingly, Employee agrees that Employee will not (directly or indirectly) at any time, whether during or for a period of seven (7) years after Employee’s employment with the Company:
(i) knowingly use for personal benefit or for any other reason not authorized by the Company any Confidential Information that Employee may acquire or has acquired by reason of Employee’s employment with the Company, or;
(ii) disclose any such Confidential Information to any person or entity except (A) in the performance of Employee obligations to the Company hereunder, (B) as required by a court of competent jurisdiction, (C) in connection with the enforcement of Employee rights under this Agreement, or (D) with the prior consent of the Board of Directors of the Company.
     As used herein, “Confidential Information” includes proprietary and confidential information with respect to the facilities and methods of the Company, reagents, chemical compounds, cell lines or subcellular constituents, organisms, or other biological materials, trade secrets, and other Intellectual Property, systems, patent applications, procedures, manuals, confidential reports, financial information, business plans, prospects, or opportunities, personnel information, or lists of customers and suppliers which are generally known only to the Company provided, however, that Confidential Information shall not include any information that is known or becomes generally known or available publicly other than as a result of disclosure by Employee which is not permitted as described in clause (ii) above, or the Company discloses same to others without obtaining an agreement of confidentiality.
     Employee confirms that all Confidential Information is the exclusive property of the Company. All business records, papers, documents and electronic materials kept or made by Employee relating to the business of the Company which comprise Confidential Information shall be and remain the property of the Company during the Employee’s employment and at all times thereafter. Upon the termination, for any reason, of Employee’s employment with the Company, or upon the request of the Company at any time, Employee shall deliver to the
         
Exhibit 1        
Mark W. Schwartz, Ph.D.   Page 2 of 6    

 


 

Company, and shall retain no copies of any written or electronic materials, records and documents made by Employee or coming into Employee’s possession concerning the business or affairs of the Company and which comprise Confidential Information.
     7. During the term of Employee’s employment with the Company and for one (1) year thereafter (the “Restricted Period”), the Employee shall not directly or indirectly, for Employee’s own account or for the account of others, as an officer, director, stockholder (other than as the holder of less than 1% of the outstanding stock of any publicly traded company), owner, partner, employee, promoter, consultant, manager or otherwise participate in the promotion, financing, ownership, operation, or management of, or assist in or carry on through proprietorship, a corporation, partnership, or other form of business entity which is in competition with the Company in the field of the development of pharmaceutical vaccine products or vaccine product candidates for the treatment of HER2-positive breast cancer (the “Company Business”) within the United States or any other country in which the Company is conducting or is actively seeking or planning to conduct the Company Business as of the date of such termination. Notwithstanding the foregoing, except as otherwise agreed to in writing, Employee shall have the right to perform such incidental services as are necessary in connection with (a) his private passive investments, (b) his charitable or community activities,(c) his participation in trade or professional organizations, and (d) his service on the board of directors (or comparable body) of one third-party corporate entity that does not compete with the Company Business.
     During the Restricted Period, the Employee shall not, whether for Employee’s own account or for the account of any other person (excluding the Company):
  (i)   solicit or contact in an effort to do business with any person who was or is a customer of the Company during the Restricted Period, or any affiliate of any such person, if such solicitation or contact is for the purpose of competition in the field of cancer vaccines for HER2 positive breast cancer with the Company; or
 
  (ii)   solicit or induce any of the Company’s employees to leave their employment with the Company or accept employment with anyone else, or hire any such employees or persons who were employed by the Company during the Restricted Period.
     Nothing herein shall prohibit or preclude the Employee from performing any other types of services that are not precluded by this Section 7 for any other person.
     The Employee shall give prompt notice to the Company of the Employee’s acceptance of employment or other fees for services relationship in the field of cancer vaccines for HER2 positive breast cancer during the Restricted Period, which notice shall include the name of, the business of, and the position that Employee shall hold with such other entity.
     8. In the event that Employee’s employment is transferred by the Company to a subsidiary, affiliated company, or acquiring company (as the case may be), Employee’s employment by such company will, for the purpose of this Confidentiality, Non-Competition, and Proprietary Information Agreement, be considered as continued employment with the Company, unless Employee executes an agreement, substantially similar in substance to this
         
Exhibit 1        
Mark W. Schwartz, Ph.D.   Page 3 of 6    

 


 

Agreement, and until the effective date of said agreement in any such company for which Employee becomes employed. It is further agreed that changes in Employee’s position or title or location unless expressly agreed to in writing will operate to terminate this Confidentiality, Non-Competition, and Proprietary Information Agreement without Cause.
     9. Upon termination of Employee’s employment for any reason, unless such employment is transferred to a subsidiary, affiliated or acquiring company of the Company, Employee agrees to leave with, or return to, the Company all records, drawings, notebooks, and other documents pertaining to the Company’s Confidential Information, whether prepared by Employee or others, as well as any equipment, tools or other devices owned by the Company, that are then in Employee’s possession, however such items were obtained, and Employee agrees not to reproduce or otherwise retain any document or data relating thereto.
     10. Employee obligations under this Agreement shall survive the termination of Employee’s employment with the Company for the respective periods specifically set forth herein regardless of the manner of, and reason for, such termination, and shall be binding upon Employee’s heirs, executors, and administrators.
     11. Employee understands and agrees that no license to any of the Company’s trademarks, patents, copyrights or other proprietary rights is either granted or implied by Employee’s access to and utilization of the Confidential Information or Intellectual Property.
     12. No delay or omission by the Company in exercising any right under this Agreement will operate as a waiver of that or any other right. A waiver or consent given by the Company on any one occasion is effective only in that instance and will not be construed as a bar to or waiver of any right on any other occasion.
     13. Employee agrees that in addition to any other rights and remedies available to the Company for any breach or threatened breach by Employee of Employee’s obligations hereunder, the Company shall be entitled to enforcement of Employee’s obligations hereunder by whatever means are at the Company’s disposal, including court injunction.
     14. The Company may assign this Agreement to any other corporation or entity which acquires (whether by purchase, merger, consolidation or otherwise) all or substantially all of the business and/or assets of the Company. In the case of a change of control of the Company in which the compensation, title, duties are reduced, or requires the Employee to relocate more than 50 miles from his then current residence, the Employee is considered Terminated without Cause, with all of the benefits and payments due Employee under Section 6.2 of the Employee Agreement. Employee shall have no rights of assignment.
     15. If any provision of this Agreement shall be declared invalid, illegal, or unenforceable, then such provision shall be enforceable to the extent that a court deems it reasonable to enforce such provision. If such provision shall be unreasonable to enforce to any extent, such provision shall be severed and all remaining provisions shall continue in full force and effect.
     16. This Agreement shall be effective as of the date first written above.
         
Exhibit 1        
Mark W. Schwartz, Ph.D.   Page 4 of 6    

 


 

     17. This Agreement shall be governed in all respects by the laws of the State of Delaware, without regard to principles of conflicts of law.
[Signature Page Follows]
         
Exhibit 1        
Mark W. Schwartz, Ph.D.   Page 5 of 6    

 


 

IN WITNESS WHEREOF , Employee has executed this Agreement as of the date set forth above:
         
     
BY: /s/ Mark W. Schwartz    
Name of Employee: Mark W. Schwartz, Ph.D.   
     
 
  ACCEPTED AND AGREED TO:

RXi Pharmaceuticals Corporation
 
 
BY: /s/ Mark J. Ahn    
Name:   Mark J. Ahn, Ph.D.   
Title:   President & Chief Executive Officer   
 
         
Exhibit 1        
Mark W. Schwartz, Ph.D.   Page 6 of 6    

 

Exhibit 10.9
Execution Version
EMPLOYMENT AGREEMENT
     The Employment Agreement (the “ Agreement ”) is made and entered into as of April 13, 2011 (the “ Effective Date ”) by and between RXi Pharmaceuticals Corporation, a Delaware corporation (the “ Company ”, or “ Employer ”), and Robert E. Kennedy, an individual and resident of the State of Arizona (“ Employee ”).
     WHEREAS, Employer and Employee desire to enter into an employment agreement under which Employee shall serve on a full-time basis as the Company’s Vice President and Chief Financial Officer on the terms set forth in the Agreement, with the term of the Agreement to commence on the Effective Date.
     NOW, THEREFORE, upon the above premises, and in consideration of the mutual covenants and agreements hereinafter contained, the parties hereto agree as follows.
     1.  Engagement . Effective as of the Effective Date, Employer shall employ Employee, and Employee shall serve, as the Company’s Vice President and Chief Financial Officer. Employee understands that his duties as Vice President and Chief Financial Officer may change from time to time during the Term (as herewith defined) in the discretion of Employer’s Board of Directors (hereinafter the “ Board ”), but such duties shall in all events be at least consistent with the duties customarily assigned to the Vice President and Chief Financial Officer of a company substantially comparable as of the Effective Date to Employer. As a condition to the Employee’s employment by the Employer, Employee and Employer shall execute the Employee Confidentiality, Non-Competition, and Proprietary Information Agreement, attached hereto as Exhibit 1 (the “ Confidentiality Agreement ”).
     2.  Duties . Employee shall perform all duties assigned to him in accordance with the terms of this Agreement by the Board faithfully, diligently and to the best of his ability. Such duties include, without limitation, the overseeing and implementation of the business plan adopted by the Board (as may be revised from time to time by the Board). Employee shall perform the services contemplated under this Agreement in accordance with the policies established by and under the direction of the Board. Employee shall have such corporate power and authority as shall reasonably be required to enable him to discharge his duties under this Agreement. Employee’s services hereunder shall be rendered in or around the vicinity of the Employee’s residence, at Employer’s offices in Worcester, MA, or such other location as the parties may agree, except for travel when and as required in the performance of Employee’s duties hereunder.
     3.  Time and Efforts . Employee shall devote all of his business time, efforts, attention and energies to Employer’s business and the discharge of his duties hereunder. Notwithstanding the foregoing, except as otherwise agreed to in writing, Employee shall have the right to perform such incidental services as are necessary in connection with (a) his private passive investments, (b) his charitable or community activities, (c) his participation in trade or professional organizations and (d) his service on the board of directors (or comparable body) of one third-party corporate entity that does not compete with the Company Business (as defined in the Confidentiality Agreement).
         
Employment Agreement        
Robert E. Kennedy   Page 1 of 7    

 


 

     4.  Term . Employee’s employment shall commence on the Effective Date and shall terminate on April 13, 2012 (the “ Term ”), unless sooner terminated in accordance with Section 6. Neither Employer nor Employee shall have any obligation to extend or renew this Agreement or Employee’s employment. Unless the parties otherwise agree in writing, Employee’s employment by Employer shall terminate upon any termination or expiration of this Agreement. Employer agrees to apply its best efforts to negotiate in good faith a replacement employment agreement with the Executive on or before September 30, 2011. In the event the parties have not entered into a new employment agreement by October 1, 2011 then, immediately upon the Employee’s written request, Employer shall terminate Employee without cause and all of the provisions of Section 6.2 shall apply.
     5.  Compensation . As the total consideration for Employee’s services rendered under the Agreement, Employer shall pay or provide Employee the following compensation and benefits:
          5.1. Salary . Employee shall initially be entitled to receive an annual base salary during the Term of One Hundred Seventy Five Thousand Dollars ($175,000) (hereinafter the “ Base Salary ”) payable in accordance with the usual payroll period of Employer, as established from time to time. If and when during the Term the Company completes one or more financing transactions in which it sells shares of its capital stock (or securities convertible into or exercisable or exchangeable for its capital stock) (each, a “ Financing ,” and collectively, the “ Financings ”) resulting in aggregate gross cash proceeds of at least $5.0 million, then the Base Salary shall be increased to Two Hundred Thousand Dollars ($200,000) per annum. Further, if and when during the Term the Company completes one or more Financings resulting in aggregate gross cash proceeds of at least $7.5 million, then the Base Salary shall be increased to Two Hundred Twenty Five Thousand Dollars ($225,000) per annum. For purposes of this Agreement, a Financing shall not include any proceeds to the Company resulting from the sale of Company capital stock pursuant to the exercise of stock options or other issuances made primarily for compensatory purposes, or pursuant to the exercise of warrants or other rights to purchase capital stock of the Company outstanding as of the Effective Date.
          5.2 Stock Option . On the Effective Date, the Company shall grant Employee a stock option (“ Option ”) under the Company’s Amended and Restated 2007 Incentive Plan (the “ Plan ”) to purchase Thirty Thousand (30,000) shares of the Company’s common stock. Except as provided in Section 6.2 of this Agreement, the Option shall vest in equal quarterly installments over 3 years beginning on the first quarterly anniversary of the Effective Date, provided, in each case, that Employee remains in the continuous employ of Employer through such quarterly anniversary date. The Option shall (a) be exercisable at an exercise price per share equal to the closing market price of the Company’s common stock on the date of the grant, (b) have a term of ten years, and (c) be on such other terms as shall be determined by the Board (or the Compensation Committee of the Board) and set forth in a customary form of stock option agreement under the Plan evidencing the Option.
          5.3. Expense Reimbursement . Employer shall reimburse Employee for reasonable business expenses incurred by Employee in connection with the performance of Employee’s duties in accordance with Employer’s usual practices and policies in effect from
         
Employment Agreement        
Robert E. Kennedy   Page 2 of 7    

 


 

time to time. Any reimbursements hereunder shall be paid to Employee promptly in a lump sum in accordance with such expense reimbursement policies and procedures then in effect.
          5.4. Vacation . Employee will be entitled to four weeks of paid “time off” (vacation days plus sick time/personal time) for each full calendar year in accordance with the Company’s policies from time to time in effect, in addition to holidays observed by the Company (for partial calendar years, the Employee’s paid “time off” will be pro-rated). Paid time off may be taken at such times and intervals as the Employee shall determine, subject to the business needs of the Company, and otherwise shall be subject to the policies of the Company, as in effect from time to time. The number of paid “time off” days will accrue per pay period and will stop accruing once 20 days have been reached.
          5.5. Employee Benefits . The Company shall provide Employee and his dependents with coverage under all medical, dental and/or vision plans and other benefit programs available to the Company’s executives and their dependents, to the extent Employee and his dependents satisfy the applicable eligibility requirements, and the Company shall pay, directly or indirectly, the monthly and annual premiums associated with any such medical plans to the same extent the Company pays such premiums for other executives of the Company. Employee shall be eligible to participate in any medical insurance and other employee benefits made available by Employer to all senior executives and/or all of employees of Employer under Employer’s plans and employment policies in effect during the Term. Employee acknowledges and agrees that, any such plans or policies now or hereafter in effect may be modified or terminated by Employer at any time in its discretion.
          5.6. Payroll Taxes . Employer shall have the right to deduct from the compensation and benefits due to Employee hereunder any and all sums required for social security and withholding taxes and for any other federal, state, or local tax or charge which may be in effect or hereafter enacted or required as a charge on the compensation or benefits of Employee.
     6.  Termination . The Agreement and Employee’s employment may be terminated as set forth in this Section 6.
          6.1. Termination by Employer for Cause; Termination by Employee . Employer may terminate Employee’s employment hereunder for Cause upon notice to Employee, and Employee may terminate his employment hereunder, for any reason or no reason, upon notice to Employer. Cause for the purpose of this Agreement shall mean any of the following:
          (a) Employee’s breach of any material term of this Agreement including its Exhibits; provided that the first occasion of any particular breach shall not constitute Cause unless Employee shall have previously received written notice from Employer stating the nature of such breach and affording Employee at least ten (10) days to correct such breach;
          (b) Employee’s conviction of, or plea of guilty or nolo contendere to, any felony or other crime of moral turpitude;
         
Employment Agreement        
Robert E. Kennedy   Page 3 of 7    

 


 

          (c) Employee’s act of fraud or dishonesty injurious to Employer or its reputation;
          (d) Employee’s continual failure or refusal to perform his material duties as required under the Agreement after written notice from Employer stating the nature of such failure or refusal and affording Employee at least ten days to correct the same;
          (e) Employee’s act or omission that, in the reasonable determination of Employer’s Board (or a Committee of the Board), indicates alcohol or drug abuse by Employee; or
          (f) Employee’s act or personal conduct that, in the judgment of the Board (or a Committee of the Board), gives rise to a material risk of liability of Employee or Employer under federal or applicable state law for discrimination, or sexual or other forms of harassment, or other similar liabilities to subordinate employees.
          Upon termination of Employee’s employment by Employer for Cause or by Employee for any reason, all compensation and benefits to Employee hereunder shall cease except that Employee shall be entitled to payment, not later than three days after the date of termination, of (i) any accrued but unpaid salary and unused vacation time (only as accrued during the then-current year of employment), and (ii) reimbursement of business expenses accrued but unpaid as of the date of termination. In addition, Employer’s indemnification obligations shall remain in effect in accordance with the terms thereof.
          6.2. Termination by Employer without Cause . Employer may also terminate Employee’s employment without Cause during the Term; provided, however, that (i) Employer shall remain obligated to continue paying Employee’s Base Salary at the time of termination for the remainder of the Term, and (ii) Employee’s Option shall continue to vest for the remainder of the Term. Upon any termination pursuant to this paragraph, Employee shall, not later than three days after the date of termination, be entitled to payment of any unused vacation time (only as accrued as of the date of such termination and in accordance with applicable law) and reimbursement of business expenses accrued but unpaid as of the date of termination.
     7.  Equitable Remedies; Injunctive Relief . Employee hereby acknowledges and agrees that monetary damages are inadequate to fully compensate Employer for the damages that would result from a breach or threatened breach of the Confidentiality Agreement and, accordingly, that Employer shall be entitled to equitable remedies, including, without limitation, specific performance, temporary restraining orders, and preliminary injunctions and permanent injunctions, to enforce such Section without the necessity of proving actual damages in connection therewith. The provision shall not, however, diminish Employer’s right to claim and recover damages or enforce any other of its legal or equitable rights or defenses.
     8.  Indemnification . Employer and Employee acknowledge that, as the Vice President and Chief Financial Officer of Employer, Employee shall be a corporate officer of Employer and, as such, Employee shall be entitled to indemnification to the full extent mandated
         
Employment Agreement        
Robert E. Kennedy   Page 4 of 7    

 


 

by Employer to its officers, directors and agents under the Employer’s Certificate of Incorporation and Bylaws as in effect as of the date of this Agreement.
     9.  Severable Provisions . The provisions of this Agreement are severable and if any one or more provisions is determined to be illegal or otherwise unenforceable, in whole or in part, the remaining provisions, and any partially unenforceable provisions to the extent enforceable, shall nevertheless be binding and enforceable.
     10.  Successors and Assigns . This Agreement shall inure to the benefit of and shall be binding upon and enforceable by Employer, its successors and assigns and Employee and his heirs and representatives; provided, however, that neither party may assign the Agreement without the prior written consent of the other party. Employer will cause any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/or assets of Employer to assume expressly and agree to perform this Agreement in the same manner and to the same extent that Employer would have been required to perform it.
     11.  Entire Agreement . This Agreement, including the Confidentiality Agreement, contains the entire agreement of the parties relating to the subject matter hereof, and the parties hereto have made no agreements, representations or warranties relating to the subject matter of the Agreement that are not set forth otherwise therein or herein. Except as expressly provided herein, this Agreement (including the Confidentiality Agreement) supersedes any and all prior or contemporaneous agreements, written or oral, between Employee and Employer relating to the subject matter hereof. Any such prior or contemporaneous agreements, as well as that certain Employment Agreement between Employee and Apthera, Inc. (“ Apthera ”) dated April 1, 2010, as amended on July 1, 2010 (the “ Prior Agreement ”), are hereby terminated and of no further effect, and Employee, by the execution hereof, agrees that any compensation provided for under any such agreements is specifically superseded and replaced by the provisions of this Agreement (including the Confidentiality Agreement). Employee acknowledges that all compensation and other obligations owed to Employee by Apthera pursuant to the Prior Agreement have been fully and finally paid and satisfied as of the Effective Date.
     12.  Amendment . No modification of this Agreement shall be valid unless made in writing, approved by the Employer’s Board (or a committee of the Board) and signed by the parties hereto and unless such writing is made by an executive officer of Employer (other than Employee). The parties hereto agree that in no event shall an oral modification of this Agreement be enforceable or valid.
     13.  Governing Law; Arbitration . This Agreement is and shall be governed and construed in accordance with the laws of the State of Delaware without giving effect to the choice-of-law rules of Delaware. Except to the extent a remedy is sought as described in Section 7, above, any dispute arising out of, or relating to, this Agreement or the breach thereof, or regarding the interpretation thereof, shall be exclusively decided by binding arbitration conducted in Los Angeles, California in accordance with the rules of the American Arbitration Association (the “AAA”) then in effect before a single arbitrator appointed in accordance with such rules. Judgment upon any award rendered therein may be entered and enforcement
         
Employment Agreement        
Robert E. Kennedy   Page 5 of 7    

 


 

obtained thereon in any court having jurisdiction. Each of the parties agrees that service of process in such arbitration proceedings shall be satisfactorily made upon it if sent by registered mail addressed to it at the address referred to in Section 14 below. The costs of such arbitration shall be borne proportionate to the finding of fault as determined by the arbitrator. Judgment on the arbitration award may be entered by any court of competent jurisdiction.
     14.  Notice . All notices and other communications under this Agreement shall be in writing and mailed, electronically mailed, telecopied (in case of notice to Employer only) or delivered by hand or by a nationally recognized courier service guaranteeing overnight delivery to a party at the following address (or to such other address as such party may have specified by notice given to the other party pursuant to the provision):
If to Employer:
RXi Pharmaceuticals Corporation
60 Prescott St.
Worcester, MA 01605
Attention: Chief Executive Officer
Fax: (508) 767-3862
Email: mahn@rxipharma.com
If to Employee:
Through company e-mail or company regular mail box if employed by Company or if not employed:
Robert E. Kennedy
9450 E. Larkspur Drive
Scottsdale, AZ 85260
Email: rob@rekconsultingllc.com
     15.  Survival . Sections 7 through 16 shall survive the expiration or termination of the Agreement.
     16.  Counterparts . The Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which together shall be deemed to be one and the same agreement.
     17.  Joint Participation . Employer and Employee agree and acknowledge that they have jointly participated in the negotiation and drafting of this Agreement and that this Agreement has been fully reviewed and negotiated by both Employer and Employee and their respective Counsel. In the event of an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by both Employer and Employee and no presumptions or burdens of proof shall arise favoring either Employer or Employee by virtue of the authorship of any of the provisions of this Agreement.
         
Employment Agreement        
Robert E. Kennedy   Page 6 of 7    

 


 

     18.  Attorney’s Fees . In any action or proceeding to construe or enforce any provision of the Agreement the prevailing party shall be entitled to recover its or his reasonable attorneys’ fees and other costs of suit in addition to any other recoveries.
IN WITNESS WHEREOF, the Agreement is executed as of the day and year first above written.
         
  EMPLOYER

RXi Pharmaceuticals Corporation

 
 
  By:   /s/ Mark J. Ahn   
    Name:   Mark J. Ahn, Ph.D.   
    Its:   President & Chief Executive Officer
 
  EMPLOYEE
 
 
   /s/ Robert E. Kennedy  
  Robert E. Kennedy   
     
 
         
Employment Agreement        
Robert E. Kennedy   Page 7 of 7    

 


 

Exhibit 1
RXi Pharmaceuticals Corporation
EMPLOYEE CONFIDENTIALITY, NON-COMPETITION, AND
PROPRIETARY INFORMATION AGREEMENT
     AGREEMENT, effective as of April 13, 2011, between RXi Pharmaceuticals Corporation, a Delaware corporation (the “Company”), and Robert E. Kennedy (the “Employee”).
     1. Employee will make full and prompt disclosure to the Company of all inventions, improvements, modifications, discoveries, methods, technologies, biological materials, and developments, and all other materials, items, techniques, and ideas related directly or indirectly to the business of the Company, whether patentable or not, made or conceived by Employee or under Employee’s direction during Employee’s employment with the Company, whether or not made or conceived during normal working hours, or on the premises of the Company (all of which are collectively termed “Intellectual Property” hereinafter).
     2. Employee agrees that all Intellectual Property, as defined above, shall be the sole property of the Company and its assigns, and the Company and its assigns shall be the sole owner of all patents and other rights in connection therewith. Employee hereby assigns to the Company any rights Employee may have or acquire in all Intellectual Property and all related patents, copyrights, trademarks, trade names, and other industrial and intellectual property rights and applications therefore, in the United States and elsewhere. Employee further agrees that with regard to all future developments of Intellectual Property, Employee will assist the Company in every way that may be reasonably required by the Company (and at the Company’s expense) to obtain and, from time to time, enforce patents on Intellectual Property in any and all countries that the Company may require, and to that end, Employee will execute all documents reasonably necessary for use in applying for and obtaining such patents thereon and enforcing the same, as the Company may desire, together with any assignment thereof to the Company or persons designated by the Company, and Employee hereby appoints the Company as Employee’s attorney to execute and deliver any such documents or assignments requested by the Company (but only for the purpose of executing and filing any such document). Employee’s obligation to assist the Company in obtaining and enforcing patents for Intellectual Property in any and all countries shall continue beyond the termination of Employee’s employment with the Company, but the Company shall compensate Employee at a reasonable, standard hourly rate following such termination for time directly spent by Employee at the Company’s request for such assistance.
     3. Employee hereby represents that Employee has no continuing obligation to assign to any former employer or any other person, corporation, institution, or firm any Intellectual Property as described above. Employee represents that Employee’s performance of all the terms of this Agreement and as an employee of the Company does not and will not breach any agreement to keep in confidence proprietary information acquired by Employee, in confidence or in trust, prior to Employee’s employment by the Company. Employee has not entered into, and Employee agrees not to enter into, any agreement (either written or oral), which would put Employee in conflict with this Agreement.
         
Exhibit 1        
Robert E. Kennedy   Page 1 of 6    

 


 

     4. Employee agrees to assign to the Company any and all copyrights and reproduction rights to any material prepared by Employee in connection with this Agreement and/or developed by Employee during Employee’s employment with the Company that are related directly or indirectly to the business of the Company.
     5. Employee understands and agrees that a condition of Employee’s employment and continued employment with the Company is that Employee has not brought and will not bring to the Company or use in the performance of Employee’s duties at the Company any materials or documents rightfully belonging to a former employer which are not generally available to the public.
     6. Employee recognizes that the services to be performed by Employee hereunder are special, unique, and extraordinary and that, by reason of Employee’s employment with the Company, Employee may acquire Confidential Information (as hereinafter defined) concerning the operation of the Company, the use or disclosure of which would cause the Company substantial loss and damage which could not be readily calculated and for which no remedy at law would be adequate. Accordingly, Employee agrees that Employee will not (directly or indirectly) at any time, whether during or for a period of seven (7) years after Employee’s employment with the Company:
(i) knowingly use for personal benefit or for any other reason not authorized by the Company any Confidential Information that Employee may acquire or has acquired by reason of Employee’s employment with the Company, or;
(ii) disclose any such Confidential Information to any person or entity except (A) in the performance of Employee obligations to the Company hereunder, (B) as required by a court of competent jurisdiction, (C) in connection with the enforcement of Employee rights under this Agreement, or (D) with the prior consent of the Board of Directors of the Company.
     As used herein, “Confidential Information” includes proprietary and confidential information with respect to the facilities and methods of the Company, reagents, chemical compounds, cell lines or subcellular constituents, organisms, or other biological materials, trade secrets, and other Intellectual Property, systems, patent applications, procedures, manuals, confidential reports, financial information, business plans, prospects, or opportunities, personnel information, or lists of customers and suppliers which are generally known only to the Company provided, however, that Confidential Information shall not include any information that is known or becomes generally known or available publicly other than as a result of disclosure by Employee which is not permitted as described in clause (ii) above, or the Company discloses same to others without obtaining an agreement of confidentiality.
     Employee confirms that all Confidential Information is the exclusive property of the Company. All business records, papers, documents and electronic materials kept or made by Employee relating to the business of the Company which comprise Confidential Information shall be and remain the property of the Company during the Employee’s employment and at all times thereafter. Upon the termination, for any reason, of Employee’s employment with the Company, or upon the request of the Company at any time, Employee shall deliver to the
         
Exhibit 1        
Robert E. Kennedy   Page 2 of 6    

 


 

Company, and shall retain no copies of any written or electronic materials, records and documents made by Employee or coming into Employee’s possession concerning the business or affairs of the Company and which comprise Confidential Information.
     7. During the term of Employee’s employment with the Company and for one (1) year thereafter (the “Restricted Period”), the Employee shall not directly or indirectly, for Employee’s own account or for the account of others, as an officer, director, stockholder (other than as the holder of less than 1% of the outstanding stock of any publicly traded company), owner, partner, employee, promoter, consultant, manager or otherwise participate in the promotion, financing, ownership, operation, or management of, or assist in or carry on through proprietorship, a corporation, partnership, or other form of business entity which is in competition with the Company in the field of the development of pharmaceutical products or product candidates for the treatment of HER2-positive cancer (the “Company Business”) within the United States or any other country in which the Company is conducting or is actively seeking or planning to conduct the Company Business as of the date of such termination. Notwithstanding the foregoing, except as otherwise agreed to in writing, Employee shall have the right to perform such incidental services as are necessary in connection with (a) his private passive investments, (b) his charitable or community activities,(c) his participation in trade or professional organizations, and (d) his service on the board of directors (or comparable body) of one third-party corporate entity that does not compete with the Company Business.
     During the Restricted Period, the Employee shall not, whether for Employee’s own account or for the account of any other person (excluding the Company):
  (i)   solicit or contact in an effort to do business with any person who was or is a customer of the Company during the Restricted Period, or any affiliate of any such person, if such solicitation or contact is for the purpose of competition with the Company; or
 
  (ii)   solicit or induce any of the Company’s employees to leave their employment with the Company or accept employment with anyone else, or hire any such employees or persons who were employed by the Company during the Restricted Period.
     Nothing herein shall prohibit or preclude the Employee from performing any other types of services that are not precluded by this Section 7 for any other person.
     Employee has carefully read and considered the provisions of this Section 7 (including the Restricted Period, scope of activity to be restrained, and the restriction’s geographical scope) and concluded them to be fair, appropriate and reasonably required for the protection of the legitimate business interests of the Company, its officers, directors, employees, creditors, and shareholders. Employee understands that the restrictions contained in this Section may limit Employee’s ability to engage in a business competitive to the Company’s business, but acknowledges that Employee will receive adequate remuneration and other benefits from the Company hereunder to justify such restrictions.
     The Employee shall give prompt notice to the Company of the Employee’s acceptance of employment or other fees for services relationship during the Restricted Period, which notice
         
Exhibit 1        
Robert E. Kennedy   Page 3 of 6    

 


 

shall include the name of, the business of, and the position that Employee shall hold with such other entity.
     8. In the event that Employee’s employment is transferred by the Company to a subsidiary, affiliated company, or acquiring company (as the case may be), Employee’s employment by such company will, for the purpose of this Confidentiality, Non-Competition, and Proprietary Information Agreement, be considered as continued employment with the Company, unless Employee executes an agreement, substantially similar in substance to this Agreement, and until the effective date of said agreement in any such company for which Employee becomes employed. It is further agreed that changes in Employee’s position or title unless expressly agreed to in writing will operate to terminate this Confidentiality, Non-Competition, and Proprietary Information Agreement without Cause.
     9. Upon termination of Employee’s employment for any reason, unless such employment is transferred to a subsidiary, affiliated or acquiring company of the Company, Employee agrees to leave with, or return to, the Company all records, drawings, notebooks, and other documents pertaining to the Company’s Confidential Information, whether prepared by Employee or others, as well as any equipment, tools or other devices owned by the Company, that are then in Employee’s possession, however such items were obtained, and Employee agrees not to reproduce or otherwise retain any document or data relating thereto.
     10. Employee obligations under this Agreement shall survive the termination of Employee’s employment with the Company for the respective periods specifically set forth herein regardless of the manner of, and reason for, such termination, and shall be binding upon Employee’s heirs, executors, and administrators.
     11. Employee understands and agrees that no license to any of the Company’s trademarks, patents, copyrights or other proprietary rights is either granted or implied by Employee’s access to and utilization of the Confidential Information or Intellectual Property.
     12. No delay or omission by the Company in exercising any right under this Agreement will operate as a waiver of that or any other right. A waiver or consent given by the Company on any one occasion is effective only in that instance and will not be construed as a bar to or waiver of any right on any other occasion.
     13. Employee agrees that in addition to any other rights and remedies available to the Company for any breach or threatened breach by Employee of Employee’s obligations hereunder, the Company shall be entitled to enforcement of Employee’s obligations hereunder by whatever means are at the Company’s disposal, including court injunction.
     14. The Company may assign this Agreement to any other corporation or entity which acquires (whether by purchase, merger, consolidation or otherwise) all or substantially all of the business and/or assets of the Company. Employee shall have no rights of assignment.
     15. If any provision of this Agreement shall be declared invalid, illegal, or unenforceable, then such provision shall be enforceable to the extent that a court deems it reasonable to enforce such provision. If such provision shall be unreasonable to enforce to any
         
Exhibit 1        
Robert E. Kennedy   Page 4 of 6    

 


 

extent, such provision shall be severed and all remaining provisions shall continue in full force and effect.
     16. This Agreement shall be effective as of the date first written above.
     17. This Agreement shall be governed in all respects by the laws of the State of Delaware, without regard to principles of conflicts of law.
[Signature Page Follows]
         
Exhibit 1        
Robert E. Kennedy   Page 5 of 6    

 


 

IN WITNESS WHEREOF , Employee has executed this Agreement as of the date set forth above:
         
     
BY:    /S/ Robert E. Kennedy    
  Name of Employee: Robert E. Kennedy     
       
 
ACCEPTED AND AGREED TO:

RXi Pharmaceuticals Corporation
 
   
BY:   /s/ Mark J. Ahn, Ph.D.     
  Name:   Mark J. Ahn, Ph.D.     
  Title:   President & Chief Executive Officer     
 
         
Exhibit 1        
Robert E. Kennedy   Page 6 of 6    

 

Exhibit 10.10
RXI PHARMACEUTICALS CORPORATION
SCIENTIFIC ADVISORY AGREEMENT
This Scientific Advisory Agreement (the “Agreement”) dated as of April 13, 2011, is made by Dr. George E. Peoples (the “Advisor”) and RXi Pharmaceuticals Corporation, a Delaware corporation (“RXi” and together with the Advisor, the “Parties”).
AGREEMENT
1. Services. As of the Effective Date, RXi shall retain the Advisor, and the Advisor agrees to serve, as a scientific advisor to RXi and to consult with RXi in the Field (as hereinafter defined). The Advisor agrees to provide to RXi such services in the Field as are customarily performed by a scientific advisor to a company such as RXi (the “Services”). The Advisor is being engaged by RXi as a consultant for the exchange of ideas only and shall not direct or conduct research for or on behalf of RXi. The Services will include, without limitation:
    Consulting with RXi’s management within the Advisor’s professional area of expertise from time to time as reasonably requested by RXi;
 
    Exchanging strategic and business development ideas with RXi;
 
    Chairing the Scientific Advisory Board (SAB); and
 
    Attending scientific, medical, regulatory or business meetings with RXi’s management, such as United States Food & Drug Administration meetings, meetings with strategic or potential strategic partners and other meetings relevant to the Advisor’s area of expertise.
For purposes of this Agreement, the term “Field” means the development of pharmaceutical products or product candidates for the treatment of HER2-positive cancer, or may directly compete with NeuVax. The Advisor is agreeing to provide the Services under this Agreement in consideration of the compensation provided in Section 3 hereof. During the Term of this Agreement, without the prior written consent of RXi, the Advisor will not be employed by or otherwise render services to another company engaged in the Field.
2. Performance of Services. As of the Effective Date, the Advisor agrees to make himself available to render the Services, at such time or times and location or locations as may be mutually agreed, from time to time at the request of RXi. The Advisor agrees not to perform any Services for RXi on the premises of his current employer, US Army (which is referred to as the “Principal Institution”), any academic institution or any hospital with which he is or may become affiliated (each such Principal Institution, academic institution and hospital an “Affiliated Institution”) or with the respective facilities or funds of any such Affiliated Institution which could result in claims by such Affiliated Institution of rights in any Inventions (as defined in Section 7 hereof ), without the express prior agreement of RXi and the Affiliated Institution, as appropriate. Unless covered by an appropriate agreement between any third party (other than an Affiliated Institution) and RXi, the Advisor shall not knowingly engage in any activities or use any facilities in the course of providing Services which could result in claims of ownership to any Inventions being made by such third party. The Advisor agrees to devote his reasonable and diligent efforts to the performance of the Services.

 


 

3. Compensation. RXi will compensate the Advisor for providing the Services to RXi as follows, with such compensation to be the full consideration for the Services:
      (A) Cash Compensation. The Advisor will receive an up-front $50,000 retainer fee and a monthly consulting fee of $15,000 during the Term, payable on the last day of each calendar month and pro rated for each partial month of engagement hereunder.
      (B)  Stock Option . On the Effective Date, the Company shall grant the Advisor a stock option (“ Option ”) under the Company’s Amended and Restated 2007 Incentive Plan (the “ Plan ”) to purchase One Hundred Thousand (100,000) shares of the Company’s common stock. The Option shall vest in equal quarterly installments over 3 years beginning on the first quarterly anniversary of the Effective Date, provided, in each case, that the Advisor remains in the continuous engagement of the Company through such quarterly anniversary date. The Option shall (a) be exercisable at an exercise price per share equal to the closing market price of the Company’s common stock on the date of the grant, (b) have a term of ten years, and (c) be on such other terms as shall be determined by the Board (or the Compensation Committee of the Board) and set forth in a customary form of stock option agreement under the Plan evidencing the Option.
      (C) Expenses. RXi shall promptly reimburse the Advisor for reasonable out-of-pocket expenses, including, without limitation, travel expenses incurred by him in the performance of the Services, following RXi’s receipt of a request for reimbursement from the Advisor. The Advisor shall provide RXi with documentation supporting all such expenses within 30 days of incurring the expense.
4. Principal Institution. RXi recognizes that the activities of the Advisor are or will be subject to the rules and regulations of the Principal Institution and any other Affiliated Institution, now or in the future, and RXi agrees that the Advisor shall be under no obligation to perform Services if such performance would conflict with such rules and regulations, or constitute a conflict of interest under the relevant policies of the Affiliated Institution. The Advisor has no reason to believe that the Advisor’s performance of any of the services contemplated by this Agreement will conflict with the applicable rules or policies of any Affiliated Institution, each as presently in effect. In the event such rules and regulations shall, in RXi’s reasonable opinion or the reasonable opinion of the Advisor, substantially interfere with the performance of Services by the Advisor, RXi or the Advisor may, notwithstanding anything herein to the contrary, terminate this Agreement without liability to the other party upon 30 days notice. The Advisor shall provide copies to RXi of all status reports he delivers and other material correspondences he has with any Affiliated Institution concerning this Agreement or the Services within three (3) business days of his delivery or receipt of such report or correspondence, provided that the policies of any Affiliated Institution permit him to do so, and provided further that RXi agrees to hold any such report or correspondence in confidence.
5. Term; Termination; Effect of Termination.
      (A) Term; Termination. The Advisor’s performance of Services shall commence on the Effective Date and shall continue until terminated pursuant to the terms of this Agreement (the “Term”). Either party may terminate this Agreement by providing 30 days’ written notice to the other party. In addition, RXi may terminate this Agreement (in addition to any other available

-2-


 

remedy) at any time for Cause. The term “Cause” shall mean the Advisor’s material breach of this Agreement which goes uncured for more than 15 days following written notice from RXi, the Advisor’s conviction of or plea of no contest to any felony, or the Advisor’s act or failure to act that materially and adversely affects the business or reputation of RXi.
      (B) Effect of Termination. Upon termination of this Agreement, the Advisor shall be entitled to payment, not later than three (3) business days after the date of termination, of (i) any accrued but unpaid portion of his monthly consulting fee, prorated for any partial month of service prior to the date of termination, and (ii) reimbursement of out-of-pocket expenses accrued but unpaid as of the date of termination.
      (C) Survival of Certain Provisions. No termination of this Agreement shall relieve the Advisor or RXi of any obligations hereunder which by their terms are intended to survive the termination of the Advisor’s association with RXi, including, but not limited to, the obligations of Sections 3 (as to only those provisions that are specifically described as being applicable after the Term), 7 through 11, 14, 17, 18, and 21 through 23 hereof.
      (D) Return of RXi Property. Upon termination of this Agreement for any reason, the Advisor shall promptly deliver to RXi any and all property of RXi or their customers, licensees, licensors, or affiliates provided to the Advisor pursuant to this Agreement which may be in his possession or control, including without limitation, products, memoranda, notes, diskettes, records, reports, laboratory notebooks, or other documents or photocopies of the same and shall destroy any Confidential Information (as defined in Section 8 hereof ) in tangible form.
6. Independent Contractor. For purposes of this Agreement and all Services to be provided hereunder, Advisor shall not be considered a partner, co-venturer, agent, employee or representative of Company, but shall remain in all respects an independent contractor, and neither party shall have any right or authority to make or undertake any promise, warranty or representation, to execute any contract, or otherwise to assume any obligation or responsibility in the name of or on behalf of the other party. Without limiting the generality of the foregoing, Advisor shall not be considered an employee of Company for purposes of any state or federal laws relating to unemployment insurance, social security, workers compensation or any regulations which may impute an obligation or liability to Company by reason of an employment relationship. Advisor agrees to pay all income, FICA, and other taxes or levies imposed by any governmental authority on any compensation that Advisor receives under this Agreement. Advisor shall indemnify, defend and hold harmless Company and its officers and employees from and against any and all losses, damages, liabilities, obligations, judgments, penalties, fines, awards, costs, expenses and disbursements (including without limitation, the costs, expenses and disbursements, as and when incurred, of investigating, preparing or defending any claim, action, suit, proceeding or investigation) suffered or incurred by Company as a result of any allegation that Advisor is an employee of Company by virtue of performing any work for or on behalf of Company hereunder or otherwise.
7. Inventions. The Advisor shall promptly disclose to RXi, and, subject to the terms of the third paragraph of this Section 7, hereby assigns and agrees to assign to RXi (or as otherwise directed by RXi), his full right, title and interest, if any, to all Inventions (as defined below). The Advisor agrees to cooperate fully with RXi, its attorneys and agents, in the preparation and filing

-3-


 

of all papers and other documents as may be required to perfect RXi’ s rights in and to any of such Inventions, including, but not limited to, execution of any and all applications for domestic and foreign patents, copyrights or other proprietary rights and the performance of such other acts (including, among others, the execution and delivery of instruments of further assurance or confirmation) requested by RXi to assign the Inventions to RXi and to permit RXi to file, obtain and enforce any patents, copyrights or other proprietary rights in the Inventions, all at RXi’s sole cost and expense. The Advisor hereby designates RXi as his agent, and grants to RXi a power of attorney with full power of substitution, which power of attorney shall be deemed coupled with an interest, for the purpose of effecting any such assignment hereunder from the Advisor to RXi in the event the Advisor should fail or refuse to sign and deliver any document in connection with perfecting the foregoing rights of RXi within 10 days following RXi’s request; provided that, in each case in which RXi intends to exercise this right (i) it shall give the Advisor 30 days written notice, by certified mail that they intend to exercise their rights under this sentence, which notice shall refer to this Agreement and shall be accompanied by (a) copies of the documents that RXi intends to execute or file, or a description of the other acts that Companies intend to take, and (b) reasonably sufficient information about the Invention or other intellectual property to which the documents or acts relate for the Advisor to make a determination of whether the document or acts relate to an Invention; and (ii) RXi may not exercise its rights under this sentence if the Advisor notifies RXi within the 30-day period referred to above that the Advisor disagrees.
     “Inventions” shall mean, for purposes of this Section 7, ideas, discoveries, creations, manuscripts and properties, innovations, improvements, know-how, inventions, trade secrets, apparatus, developments, techniques, methods, biological processes, cell lines, laboratory notebooks and formulas (whether or not patentable or copyrightable or constituting trade secrets) conceived, made or discovered by the Advisor (whether alone or with others) within the Field (i) solely as a direct result of consulting with RXi under this Agreement and (ii) not in the course of the Advisor’s activities as an employee of Principal Institution. In no event shall the Advisor’s obligations hereunder relate to any right, title or interest that the Advisor may have in ideas, discoveries, creations, manuscripts and properties, innovations, improvements, know-how, inventions, trade secrets, apparatus, developments, techniques, methods, biological processes, cell lines, laboratory notebooks and formulas (whether or not patentable or copyrightable or constituting trade secrets) conceived, made or discovered by the Advisor (whether alone or with others) with the use of facilities or findings of any Affiliated Institution and that the Advisor is required to assign to his Affiliated Institution pursuant to the rules and regulations of such Affiliated Institution. Further, RXi will have no rights by reason of this Agreement in any publication, invention, discovery, improvement, or other intellectual property whatsoever, whether or not publishable, patentable, or copyrightable, which is developed as a result of a program of research financed, in whole or in part, by funds provided by or under the control of the Principal Institution. The Advisor agrees to not knowingly use or incorporate any third party proprietary information into any Inventions or to disclose such information to RXi. Upon termination of this Agreement with RXi, the Advisor shall provide to RXi in writing a full, signed statement of all Inventions in which the Advisor participated prior to termination of this Agreement.
     RXi acknowledges and agrees that it will enjoy no priority or advantage as a result of the consultancy created by this Agreement in gaining access, whether by license or otherwise, to any

-4-


 

proprietary information or intellectual property that arises from any research undertaken by the Advisor in his capacity at the Principal Institution.
8. Confidentiality. The Advisor may disclose to RXi any information that the Advisor would normally freely disclose to other members of the scientific community at large, whether by publication, by presentation at seminars, or in informal scientific discussions. However, the Advisor shall not disclose to RXi information that is proprietary to Principal Institution and is not generally available to the public other than through formal technology transfer procedures.
     During the Term, the Advisor will be exposed to certain information concerning RXi’s research, business, Inventions, products, proposed new products, designs, clinical testing programs, manufacturing processes and techniques, customers, and other information and materials that embody trade secrets or technical or business information that is confidential and proprietary to RXi and is not generally known to the public (collectively, “Confidential Information”). Confidential Information shall not include information that (i) is in the public domain on the Effective Date of this Agreement, (ii) is or was disclosed to the Advisor by a third party having no fiduciary relationship with RXi and having no known obligation of confidentiality with respect to such information, (iii) is or was independently known or developed by the Advisor without reference to the Confidential Information as reasonably demonstrated by the Advisor by written records or (iv) is required by law or in a legal proceeding to be disclosed, provided that the Advisor shall give RXi prior written notice of such proposed disclosure so that RXi may take such legal steps as they deem appropriate to protect the Confidential Information. In addition, Confidential Information does not include information generated by the Advisor, alone or with others, unless the information (i) is generated solely as a direct result of the performance of the Services and (ii) is not generated in the course of the Advisor’s activities as an employee of Principal Institution. The Advisor hereby agrees, for a period of seven (7) years following the expiration or earlier termination of this Agreement not to disclose or make use of, or allow others to use, any Confidential Information, except to RXi’s employees and representatives, without RXi’s prior written consent, unless such information becomes publicly available through no fault of the Advisor. In addition, the Advisor further agrees not to make any notes or memoranda relating to the business of RXi other than for the benefit of RXi and not to use or permit to be used at any time any such notes or memoranda other than for the benefit of RXi.
9. Injunctive Relief. The Advisor agrees that any breach of this Agreement by him could cause irreparable damage to RXi and that in the event of such breach RXi shall have the right to obtain injunctive relief, including, without limitation, specific performance or other equitable relief to prevent the violation of his obligations hereunder. It is expressly understood and agreed that nothing herein contained shall be construed as prohibiting RXi from pursuing any other remedies available for such breach or threatened breach, including, without limitation, the recovery of damages by RXi.
10. No Assignment by the Advisor. The Services to be rendered by the Advisor are personal in nature. The Advisor may not assign or transfer this Agreement or any of his rights or obligations hereunder. In no event shall the Advisor assign or delegate responsibility for actual performance of the Services to any other natural person.

-5-


 

11. Publications. The Advisor agrees that he will not at any time during the time limitations set forth in paragraph 9 hereof, publish any Confidential Information that becomes known to him as a result of his relationship with RXi which is, or pursuant to the terms hereof becomes, the property of RXi or any of its clients, customers, consultants, licensors, licensees, or affiliates except to such extent as may be necessary in the ordinary course of performing in good faith his duties as scientific advisor of RXi and with the prior written consent of RXi.
     During the Term and for a period of two years thereafter, the Advisor agrees to submit to RXi for a period of at least 30 days (the “Review Period”) a copy of any proposed manuscript or other materials to be published or otherwise publicly disclosed by the Advisor (each a “Proposed Publication”) which contains Confidential Information or discloses Inventions in sufficient time to enable RXi to determine if patentable Inventions or Confidential Information would be disclosed. Nothing herein shall be construed to restrict the Advisor’s right to publish material which does not contain Confidential Information. Following the expiration of the Review Period, if RXi does not notify the Advisor that the Proposed Publication discloses patentable Inventions or Confidential Information such Proposed Publication shall be deemed to be approved by RXi for publication. In addition, the Advisor will cooperate with RXi in this respect and will delete from the manuscript or other disclosure any Confidential Information if requested by RXi and will assist RXi in filing for patent protection for any patentable Inventions prior to publication or other disclosure.
12. No Conflicting Agreements. The Advisor represents and warrants, that as of the Effective Date, he will not be a party to any future commitments or obligations that conflict with this Agreement. In this regard, as a condition to the effectiveness of this Agreement the Advisor shall provide to RXi the written consent and acknowledgement of Principal Institution to Advisor’s entry into this Agreement. During the Term, the Advisor will not enter into any agreement either written or oral in conflict with this Agreement and will arrange to provide Services under this Agreement in such a manner and at times that such Services will not conflict with his responsibilities under any other agreement, arrangement or understanding or pursuant to any employment relationship he has at any time with any third party. In the event of any inconsistency between this Agreement and any agreement or policy of any Affiliated Institution, the agreement or policy of the Affiliated Institution shall control.
13. Other Consulting Services. RXi agrees that the Advisor may serve as a member of scientific advisory boards or in a similar capacity with, and provide consulting services to, other companies in scientific areas outside of the Field, provided that such service does not conflict or materially interfere with his Services hereunder.
14. Nonsolicitation. During the Term and for a period of one year thereafter, the Advisor, personally, will not, without RXi’s prior written consent, directly solicit the employment of any employee of RXi or its affiliates with whom the Advisor has had contact in connection with the relationship arising under this Agreement. Nothing in this Section 14 shall be deemed to prohibit general solicitations of employment by any Affiliated Institution.
15. Disclosure of Relationship. The parties each shall be entitled to disclose that the Advisor is serving as a scientific advisor to RXi and RXi may use the Advisor’s name, including in any business plan, press release, advertisement, prospectus or other offering document of RXi or its affiliates, so long as any such usage (a) is limited to reporting factual events or occurrences only,

-6-


 

and (b) is made in a manner that could not reasonably constitute a specific endorsement by the Advisor of RXi or of any program, product or service of RXi. However, RXi shall not use the Advisor’s name in any press release, or quote the Advisor in any RXi materials (including advertisements), or otherwise use the Advisor’s name in a manner not specifically permitted by the preceding sentence, unless in each case RXi obtains in advance the Advisor’s consent. The foregoing consents shall not be unreasonably withheld or delayed by the Advisor. Notwithstanding the foregoing, if, in the opinion of RXi’s counsel, RXi is required by applicable law to use the Advisor’s name in a press release or governmental filing and, under the circumstances, RXi is not reasonably able to obtain the advance written consent of the Advisor, as applicable, to such use, then RXi may proceed without obtaining the advance written consent of the Advisor.
16. Notices. All notices and other communications hereunder shall be delivered or sent by facsimile transmission, recognized courier service, registered or certified mail, return receipt requested.
If to RXi:
RXi Pharmaceuticals Corporation
60 Prescott Street
Worcester, MA 01605
Attn: Chief Executive Officer
Facsimile: 508-767-3862
If to the Advisor:
George Peoples, M.D.
120 Geneseo Road
San Antonio, TX 78209
210-824-0617
     Such notice or communication shall be deemed to have been given as of the date sent by the facsimile or delivered to a recognized courier service, or three days following the date sent by registered or certified mail.
17. Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the parties and their respective legal representatives, successors and permitted assigns. The Advisor agrees that RXi may assign this Agreement, in whole but not in part, to any purchaser of all or substantially all of its assets or to any successor corporation resulting from any merger, consolidation or other reorganization of RXi with or into such corporations. RXi also may assign this Agreement, in whole but not in part, to any person or entity controlled by, in control of, or under common control with, RXi, if it obtains the prior written consent of the Advisor, which consent shall not unreasonably be withheld or delayed; provided, however, that no such assignment shall relieve RXi of its liability to the Advisor hereunder. RXi may not otherwise assign this Agreement without the Advisor’s prior written consent.

-7-


 

18. Indemnification. RXi shall indemnify, defend and hold harmless the Advisor from any claim, loss, liability or expense (including reasonable attorney’s fees) incurred by him as a result of the performance of his Services hereunder in accordance with the terms hereof, a material breach by RXi hereof or any gross negligence or willful misconduct by RXi or its respective officers or directors in connection with this Agreement or otherwise relating to or resulting from the performance of the Services hereunder, except where such claim, loss, liability or expense is attributable primarily to the Advisor’s own gross negligence or willful misconduct.
19. Entire Agreement; Counterparts. This Agreement constitutes the entire agreement among the parties as to the subject matter hereof. No provision of this Agreement shall be waived, altered or cancelled except in writing signed by the party against whom such waiver, alteration or cancellation is asserted. This Agreement may be executed in one or more counterparts, and by different parties hereto on separate counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
20. Governing Law. This Agreement shall be governed by and construed in accordance with the internal laws of the State of Delaware, without regard to conflict of law principles.
21. Enforceability. The invalidity or unenforceability of any provision hereof as to an obligation of a party shall in no way affect the validity or enforceability of any other provision of this Agreement, provided that if such invalidity or unenforceability materially adversely affects the benefits the other party reasonably expected to receive hereunder, that party shall have the right to terminate this Agreement. Moreover, if one or more of the provisions contained in this Agreement shall for any reason be held to be excessively broad as to scope, activity or subject so as to be unenforceable at law, such provision or provisions shall be construed by limiting or reducing it or them, so as to be enforceable to the extent compatible with the applicable law as it shall then appear.
22. Construction. This Agreement has been prepared jointly and shall not be strictly construed against any party.
23. Resolution of Disputes . Except as set forth below, any dispute arising under or in connection with any matter related to this Agreement or any related agreement shall be resolved exclusively by arbitration. The arbitration will be in conformity with and subject to the applicable rules and procedures of the American Arbitration Association. All parties agree to be (i) subject to the jurisdiction and venue of any arbitration or litigation in Delaware; and (ii) bound by the decision of the arbitrator as the final decision with respect to any dispute that is to be resolved by arbitration pursuant to this Agreement.
24. Advice of Counsel . Each party acknowledges that, in executing this Agreement, such party has had the opportunity to seek the advice of independent legal counsel, and has read and understood all of the terms and provisions of this Agreement.

-8-


 

     IN WITNESS WHEREOF, the parties hereto have duly executed this Scientific Advisory Agreement as a sealed instrument as of the date first written above.
         
  RXi Pharmaceuticals Corporation
 
 
  By:   /s/ Mark J. Ahn    
    Name:   Mark J. Ahn, Ph.D.   
    Its:   President & Chief Executive Officer
 
  Advisor:
 
 
  /s/ George E. Peoples    
  George E. Peoples, M.D.    
     
 

-9-

Exhibit 10.11
[Form of] Amendment to Stock Options
Granted Under RXi Pharmaceuticals Corporation 2007 Incentive Plan
     This Amendment to Stock Options, dated as of April __, 2011, is made between RXi Pharmaceuticals Corporation, a Delaware corporation (the “Company”) and the undersigned (the “Holder”).
     WHEREAS, the Holder is the holder of options issued pursuant to the Company’s 2007 Incentive Plan (the “Plan”) to purchase shares of the Company’s common stock, $0.0001 par value (the “Common Stock”); and
     WHEREAS, the Holder and the Company have agreed to amend all options issued under the Plan to purchase shares of Common Stock held by the Holder as of the date hereof (the “Options”) in the manner set forth herein;
     NOW THEREFORE, for good and valuable consideration, the Company and the Holder hereby agree as follows:
     Notwithstanding anything to the contrary set forth in any applicable option agreement, award or certificate relating to the Options, no Option shall be exercisable unless and until the Company’s Certificate of Incorporation has been amended to increase the number of authorized shares of Common Stock to a number that is sufficient to permit the exercise or conversion in full of all then outstanding options (including the Options), warrants and other securities of the Company that are convertible into shares of Common Stock, and each Option shall thereafter be exercisable in accordance with the terms of each such Option.
     Except as modified hereby, each Option shall continue in accordance with its terms.
     This Amendment to Stock Options may be executed in counterparts, which together shall constitute a single instrument.
[Remainder of page intentionally left blank]

 


 

     This Amendment to Stock Options is executed as of the date first written above.
         
  RXi Pharmaceuticals Corporation:
 
 
  By:      
    Mark Ahn, Chief Executive Officer   
       
 
  Holder:
 
 
        
  Name:    
       
 

-2-

Exhibit 10.12
Text Marked By [* * *] Has Been Omitted Pursuant To A Request For Confidential
Treatment And Was Filed Separately With The Securities And Exchange Commission.
EXCLUSIVE LICENSE AGREEMENT
BETWEEN
THE HENRY M. JACKSON FOUNDATION FOR THE
ADVANCEMENT OF MILITARY MEDICINE, INC.
AND
RXI PHARMACEUTICALS CORPORATION
     THIS EXCLUSIVE LICENSE AGREEMENT (“Agreement”) is entered into as of the date of the last signature on the signature page of this document (the “Effective Date”), by and among The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., a tax-exempt corporation organized under the laws of the State of Maryland and having its principal offices at 1401 Rockville Pike, Suite 600, Rockville, Maryland 20852 (the “Foundation”) and RXi Pharmaceuticals Corporation (“RXi”), a corporation organized under the laws of the State of Delaware and having its principal offices at 60 Prescott Street, Worcester, MA 01605 and its wholly-owned subsidiary, Apthera, Inc. (“Apthera”). This Agreement grants a license that can be exploited by either or both of RXi and Apthera, and RXi and Apthera are referred to both individually and collectively throughout as “Licensee” but any termination of this Agreement with respect to either of RXi or Apthera shall terminate this Agreement as to both RXi and Apthera. The Foundation and Licensee sometimes are referred to collectively herein as the “Parties” or individually as a “Party.”
     WHEREAS the Foundation and the Uniformed Services University of the Health Sciences, an institution of higher learning within the Department of Defense, an agency of the United States Government, located at 4301 Jones Bridge Road, Bethesda, Maryland 20814 (“USU”) have agreed to collaborate in the development and commercialization of inventions, patents, trade secrets, and other intellectual property rights; and
     WHEREAS, the Foundation and USU are committed to the policy that ideas or creative works produced at the Foundation and USU should be used for the greatest possible public benefit and that every reasonable incentive should be provided for the prompt introduction of such ideas into public use, all in a manner consistent with the public interest; and
     WHEREAS the Foundation, by virtue of assignments from USU (which received assignment(s) from USU inventor(s)), is an owner of certain Patent Rights (as hereinafter defined) and has the right to grant licenses of said Patent Rights, subject only to a royalty-free, nonexclusive license heretofore granted to or retained by the United States Government; and
RXi — Foundation License — Optimized E75 (Peoples)

 


 

     WHEREAS Licensee has represented to Foundation, to induce Foundation to enter into this Agreement, that Licensee is experienced in the development, production, manufacture, marketing, and sale of products similar to the Licensed Products and the use of processes similar to the Licensed Processes (both as hereinafter defined) and is willing to undertake as provided in this Agreement a thorough, vigorous, and diligent program of exploiting the Patent Rights so that public utilization may result therefrom; and
     WHEREAS Licensee desires to obtain from the Foundation, and the Foundation agrees to grant to Licensee, a license upon the terms and conditions set forth herein;
     NOW, THEREFORE, in consideration of the mutual promises and covenants set forth in this Agreement, the Parties, intending to be legally bound, agree as follows:
ARTICLE I
DEFINITIONS
     As used in this Agreement, the following terms shall have the following meanings:
     1.1 “Affiliate” means, with respect to any Person, any other Person that directly or indirectly through one or more intermediaries controls, is controlled by, or is under common control with such Person. For purposes of this definition, the term “controls” (including its correlative meanings “controlled by” and “under common control with”) means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract, or otherwise.
     1.2 “Agreement” means this Agreement, including all Appendices hereto, as the same may be amended from time to time in accordance with the terms hereof.
     1.3 “Business Day” means any day other than a Saturday, a Sunday, or a day on which banking institutions in Montgomery County, Maryland are closed.
     1.4 “Confidential Information” means information, disclosed by one Party to the other Party, that is treated as proprietary or confidential by the disclosing Party and, at the time of disclosure, that is marked “proprietary” or “confidential” or that bears a marking or legend of like import restricting its use, copying, or dissemination or that is identified as being confidential in a letter or other written communication sent to the receiving Party prior to or contemporaneously with disclosure to the receiving Party. Any such information that is in another form when disclosed, such as oral or visual, shall be treated as Confidential Information only if and to the extent the disclosing Party informs the receiving Party of the proprietary or confidential nature of the information prior to or at the time of the disclosure, and thereafter creates a written record of the disclosure (marked in accordance with this Agreement) and delivers the written record to the receiving Party promptly, but in no event more than thirty (30) days after the original disclosure to the receiving Party. Confidential Information does not include any
RXi — Foundation License — Optimized E75 (Peoples)

2


 

information that (i) was known to the receiving Party without a duty of confidentiality before receipt from the disclosing Party as evidenced by written records made prior to such receipt or disclosure (when such prior knowledge did not become known to such receiving Party through disclosure by a third party known to the receiving Party to be subject to an obligation to maintain the confidentiality thereof); (ii) is or becomes a matter of public knowledge through no fault of the receiving Party or any of its agents; (iii) is rightfully received by the receiving Party from a third party without a duty of confidentiality; or (iv) is independently developed by the receiving Party as evidenced by written records of the receiving Party.
     1.5 “Field” means (a) with respect to Patent 1, the field of human therapeutics, biomarkers, and diagnostics, and (b) with respect to Patent 2, use of the HER family peptide E75 in combination with Herceptin ® and only in the field of human therapeutics, biomarkers, and diagnostics (no licensed use is granted in connection with any other peptides). “Patent 1” and “Patent 2” are defined in Appendix A.
     1.6 The term “License” has the meaning set forth in Section 2.1.
     1.7 “Licensed Process” means any process that: (a) is covered in whole or in part by an unexpired issued or pending claim contained in the Patent Rights, or (b) utilizes any Technology Rights.
     1.8 “Licensed Product” means any product or part thereof that: (a) is covered in whole or in part by an unexpired issued or pending claim contained in the Patent Rights, or (b) is manufactured by using or is employed to practice a Licensed Process or Technology Rights.
     1.9 “Marketing Approval” means the approval or authorization required for the marketing of Licensed Product or Licensed Process in the United States, the European Union, or other country within the Territory, such as the issuance of an approval action by the United States Food and Drug Administration (“FDA”) on an NDA in the United States, or the issuance of its equivalent by the European Medicines Agency in the European Union.
     1.10 “MDACC” means The University of Texas M. D. Anderson Cancer Center.
     1.11 “NDA” means a New Drug Application or Biologics License Application filed with the FDA for Marketing Approval of a Licensed Product or Licensed Process, or an equivalent application filed with any equivalent agency or governmental authority outside the United States.
     1.12 “Net Sales” means the gross revenues received by Licensee or any sublicensee(s) or Affiliate(s) from sales, leases, or other transfers of Licensed Products or Licensed Processes, less the sum of the following: sales discounts actually granted and taken; sales or use taxes actually paid; import or export duties actually paid; outbound transportation expenses actually prepaid or actually allowed; and amounts actually allowed or credited due to returns (not exceeding the original billing or invoice amount),
RXi — Foundation License — Optimized E75 (Peoples)

3


 

all as recorded by Licensee in Licensee’s official books and records in accordance with generally accepted accounting practices and consistent with Licensee’s financial statements and regulatory filings with the United States Securities and Exchange Commission, if any. No deductions shall be made for commissions paid to individuals, whether they be with independent sales agencies or regularly employed by and on the payroll of Licensee or sublicensees, or for the cost of collections.
     1.13 “Non-commercial Research Purposes” means use of Patent Rights for academic research or other not-for-profit scholarly purposes that are undertaken at a non-profit or governmental institution that does not use the Patent Rights in the production or manufacture of products for sale or the performance of services for a fee.
     1.14 “Non-royalty Sublicense Income” means all sublicense issue fees, sublicense maintenance fees, sublicense milestone payments, and similar non-royalty payments made by sublicensees to Licensee on account of sublicenses pursuant to this Agreement.
     1.15 “Patent Rights” means any or all of the following intellectual property to the extent owned or controlled by the Foundation:
          (a) The United States and foreign patents and patent applications listed in Appendix A (including any and all patents and patent applications, if any, that may be added by a future modification or amendment of this Agreement that satisfies the requirements of the last sentence of Section 10.19), and all divisions and continuations of such applications;
          (b) United States and foreign patents issued from the applications listed in Appendix A or from divisionals or continuations of such applications;
          (c) Claims of United States and foreign continuation-in-part applications, and all divisions and continuations of such continuation-in-part applications, and of the resulting patents, to the extent that the claims are directed to subject matter specifically described in the United States or foreign patent applications listed in Appendix A;
          (d) Claims of all foreign and United States counterpart patent applications to (a), (b), or (c) above, and of the resulting patents, to the extent that the claims are directed to subject matter specifically described in the patents or patent applications described in (a), (b), or (c) above; and
          (e) Any reissues, renewals, extensions, or supplementary protection certificates of patents described in (a), (b), (c), or (d) above.
Patent Rights shall not include (c), (d), or (e) above to the extent that the claims are directed to new matter that is not the subject matter described in (a) above.
     1.16 “Person” means any individual, corporation, limited liability company, general or limited partnership, joint venture, association, joint stock company, trust,
RXi — Foundation License — Optimized E75 (Peoples)

4


 

unincorporated business or organization, government or agency or political subdivision thereof, or other entity, whether acting in an individual, fiduciary, or other capacity.
     1.17 “Phase III Clinical Trial” means: (a) that portion of the drug development and review process in which an expanded clinical trial is conducted to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of an investigational new drug, as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21 or any future revisions or substitutes therefore; or (b) a similar clinical trial in the European Union or any nation other than the United States. Commencement of a Phase III Clinical Trial shall be deemed to occur upon the administration of Licensed Product (or Licensed Process) or placebo to the first patient enrolled in the Phase III Clinical Trial.
     1.18 “Technology Rights” means the Foundation’s rights in any technical information, know-how, trade secret, process, procedure, composition, device, method, formula, protocol, technique, software, design, drawing, or data that are: (a) created before the Effective Date by one or more of the inventor(s) listed in Appendix A, and (b) not specifically claimed in Patent Rights but that are necessary for practicing Patent Rights.
     1.19 “Territory” means worldwide.
     1.20 “Valid Claim” means a claim of: (a) any issued, unexpired Patent Right that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal; or (b) any pending application for Patent Right that has not been cancelled, withdrawn, or abandoned.
ARTICLE II
GRANT OF RIGHTS
     2.1 The Foundation hereby grants to Licensee and Licensee accepts, subject to the terms and conditions hereof, in the Territory and for the Field, a non-exclusive license to practice under the Technology Rights and an exclusive (even as to Foundation, except as provided in Section 2.4, and except when termination of the exclusivity of the license occurs pursuant to Article IX) license (collectively, the “License”) to practice under the Patent Rights and, to the extent not prohibited by other patents, to make, have made, use, have used, sell, have sold, export and import Licensed Products and to practice Licensed Processes, until the expiration of this Agreement, unless this Agreement shall be sooner terminated in accordance with the terms hereof.
     2.2 In order to establish a period of commercial exclusivity for Licensee, the Foundation agrees that it will not grant, in the Territory for the Field, any other license to practice under the Patent Rights or to make, have made, use, have used, sell, have sold, export or import Licensed Products or to practice the Licensed Processes, except as
RXi — Foundation License — Optimized E75 (Peoples)

5


 

required by the obligations related to Section 2.4(a) or as permitted in Section 2.4(b), during the period of time commencing with the Effective Date and ending with the first to occur of:
          (a) The expiration of all Patent Rights;
          (b) A court or tribunal, in a final decision not subject to further appeal, declaring invalid or unenforceable all claims in the Patent Rights;
          (c) The abandonment of all claims in the Patent Rights; or
          (d) The termination of this Agreement or the termination of the exclusivity of the License in accordance with Article IX
     2.3 Subject to the Foundation’s prior approval, which approval shall not be unreasonably withheld or delayed, Licensee shall have the right to grant sublicenses hereunder via written sublicense agreements. The License granted to Licensee hereunder does not extend to any Affiliate of Licensee unless and until such Affiliate enters into a written sublicense agreement with Licensee that is consistent with the requirements hereof and the Foundation approves the written sublicense agreement.
          (a) In all sublicenses granted hereunder, Licensee shall provide that the sublicense is subject and subordinate to all terms and conditions of this Agreement, except: (i) the sublicensee may not grant any sublicenses except with the Foundation’s prior express written approval, and (ii) any royalty or other payment paid by the sublicensee to Licensee may exceed the rate set forth in this Agreement. Licensee shall attach a copy of this Agreement to any sublicense agreement and shall provide a complete copy of the sublicense agreement to the Foundation promptly after signing by the parties thereto.
          (b) Licensee may not receive from any sublicensee anything of value in lieu of cash payments in consideration for any sublicense under this Agreement, without the Foundation’s prior express written approval, which shall not be unreasonably withheld or delayed.
          (c) Sublicenses may extend past the expiration date of the exclusive period but any exclusivity of such sublicenses shall expire upon the termination or expiration of Licensee’s exclusivity. Upon any termination of this Agreement, sublicensees’ rights shall also terminate, subject to Section 9.3.
     2.4 The granting and exercise of the License is subject to the following conditions:
          (a) The U.S. Government retains a nonexclusive, nontransferable, irrevocable, world-wide, paid-up license to practice all invention(s) covered by the Patent Rights or Technology Rights and to have such invention(s) practiced by or on behalf of the U.S. Government and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which the U.S.
RXi — Foundation License — Optimized E75 (Peoples)

6


 

Government is a signatory.
          (b) The Foundation and the USU reserve the rights to make and use, and grant to others non-exclusive licenses to make and use for Non-commercial Research Purposes the subject matter described and claimed in Patent Rights or Technology Rights.
          (c) Licensee shall cause any Licensed Product produced for use or sale in the United States to be manufactured substantially in the United States.
     2.5 The License granted hereunder shall not be construed to confer any rights upon Licensee (or sublicensees, if any) by implication, estoppel, or otherwise as to any technology not included in the Patent Rights or the Technology Rights as defined herein.
ARTICLE III
LICENSE FEES AND MILESTONE AND
ROYALTY PAYMENTS
     3.1 Licensee shall pay to the Foundation a non-creditable, non-refundable License issue royalty in the sum of [* * *] ([* * *] for Patent 1 Patent Rights and [* * *] for Patent 2 Patent Rights) within thirty (30) after the Effective Date.
     3.2 No later than July 1 of each calendar year after the Effective Date of this Agreement, Licensee shall pay to the Foundation the following minimum annual non-refundable license maintenance royalties: [* * *] for Patent 1 Patent Rights and [* * *] for Patent 2 Patent Rights. Commencing on January 1 of the calendar year immediately after the first sale of a Licensed Product or Licensed Process anywhere in the Territory, and continuing annually thereafter, such minimum annual non-refundable license maintenance royalties shall increase to: [* * *] for Patent 1 Patent Rights and [* * *] for Patent 2 Patent Rights. Payments under this Section 3.2 shall be creditable against other royalties (but not against milestone payments, if any) due pursuant to Sections 3.3 and 3.4 in the same calendar year only, but shall not be credited against any milestone payments nor against royalties due for any other calendar year.
     3.3 In further consideration for the rights to Patent Rights and Technology Rights granted hereunder, Licensee shall pay to the Foundation semi-annually, within sixty (60) days after each calendar half year ending June 30 and December 31, a royalty according to the following schedule and provisions:
          (a) For sales of Licensed Products or Licensed Processes in the U.S.: a royalty of [* * *] of Net Sales until the expiration or termination of the E75 license agreement dated September 11, 2006 between Apthera, MDACC and the Foundation; thereafter [* * *] of Net Sales through the remaining term of this Agreement;
RXi — Foundation License — Optimized E75 (Peoples)

7


 

For sales of Licensed Products or Licensed Processes outside the U.S., on a country-by-country basis, a royalty of:
               (i) [* * *] of Net Sales in any and all jurisdictions in which a Licensed Product or Licensed Process is covered by at least one Valid Claim, and
               (ii) In all other jurisdictions, [* * *] of Net Sales until the expiration or termination of the E75 license agreement dated September 11, 2006 between Apthera, MDACC and the Foundation, and [* * *] of Net Sales thereafter.
          (b) Overriding provisions on royalty rates
               (i) Royalty rates for the intellectual property licensed under this Agreement are reduced on a pro rata basis among all licensors such that combined stacking royalties with existing E75 intellectual property are limited to [* * *] where a Licensed Product or Licensed Process is covered by at least one Valid Claim and [* * *] where not covered by a Valid Claim.
               (ii) If the license pursuant to this Agreement is converted to a non-exclusive one and if other non-exclusive licenses in the same field and territory are granted, after such conversion the above royalty rates shall not exceed the royalty rate to be paid by other licensees in the same field and territory during the term of the non-exclusive license.
               (iii) On sales of Licensed Products or Licensed Processes between Licensee and its sublicensees for resale, the royalty shall be paid only on the Net Sales of the sublicensees and not on the Net Sales by Licensee to its sublicensees for resale.
          (c) In the case of sublicenses, Licensee shall also pay to the Foundation a royalty on Non-royalty Sublicense Income according to the following schedule and provisions:
               (i) [* * *] until the expiration or termination of the E75 license agreement dated September 11, 2006 between Apthera, MDACC and the Foundation, and thereafter
               (ii) [* * *] throughout the remaining term of this Agreement.
     3.4 Licensee shall pay to the Foundation the following milestone payment(s) after the associated milestone occurs (in each instance):
          (a) [* * *]; due within thirty (30) days following the issuance of the first patent in the Territory related to any portion of the intellectual property included within the Patent Rights.
RXi — Foundation License — Optimized E75 (Peoples)

8


 

          (b) [* * *]; due within thirty (30) days following the start (administration of the first dose to the first patient) of any Phase III trial.
          (c) [* * *]; due within thirty (30) days following the first filing of the first NDA (or equivalent filing) for any Licensed Product.
          (d) [* * *]; due within thirty (30) days following the first Marketing Approval of any Licensed Product; and
          (e) [* * *]; due within six (6) months of the first commercial sale of any Licensed Product anywhere in the Territory.
     3.5 All payments due hereunder shall be paid in full, without deduction for any taxes or other fees imposed by any government or any transfer, collection, or similar charges; any such tax, fee, or charge shall be paid by Licensee.
     3.6 Royalty payments shall be paid, by check or by wire transfer, in United States dollars in Rockville, Maryland, or at such other place and manner as the Foundation may designate in writing consistent with the laws and regulations controlling in any foreign country. If any currency conversion is required in connection with any payments due hereunder, such conversion shall be made by using the exchange rate existing in the United States as reported in The Wall Street Journal on the last Business Day of the calendar half-year reporting period to which such payments relate.
     3.7 [* * *] shall be due to the Foundation for any Licensed Product as to which the manufacture, use, lease, or sale, is or shall be covered by more than one Patent Rights patent application or Patent Rights patent licensed hereunder.
     3.8 If Licensee is required to pay royalties to a third party to avoid infringing such third party’s intellectual property rights, as documented by a written advice of Licensee’s patent counsel, Licensee shall be entitled to reduce the royalty payments made pursuant to Section 3.3 by the amounts paid to such thirty party; provided, however, that the amounts paid pursuant to Section 3.3 will not be reduced by more than [* * *] and in no event shall be less than [* * *]. Such reduction of royalty payments paid pursuant to Section 3.3 shall occur only in the same calendar year as such required payment is made to such third party. Any such required payment shall not be applied to reduce any milestone payments, nor to reduce any royalties due for any other calendar year.
ARTICLE IV
DUE DILIGENCE
     4.1 Licensee shall use its commercially reasonable efforts to bring one or more of the Licensed Products and the Licensed Processes to market, in the Territory for the Field, through a thorough, vigorous, and diligent program for exploitation of the Patent Rights and to continue active, diligent development and marketing efforts for such
RXi — Foundation License — Optimized E75 (Peoples)

9


 

Licensed Products and Licensed Processes throughout the life of this Agreement. Thereafter, until the expiration of this Agreement, Licensee shall endeavor to keep the Licensed Products and the Licensed Processes continuously available to the public in the Territory for the Field.
     4.2 In addition, Licensee shall adhere to the following milestones:
          (a) Licensee shall deliver to the Foundation on or before sixty (60) days following the Effective Date a business plan showing the estimated amount of money, number and kind of personnel, and time budgeted and planned for each phase of development of the Licensed Products and the Licensed Processes during the period ending on the first anniversary of the Effective Date. Licensee shall provide an updated, similarly detailed business plan to the Foundation each year on or before the anniversary of the Effective Date.
          (b) Licensee shall enter into a Phase III Clinical Trial no later than December 31, 2012 and shall have commenced the first sale of any Licensed Product no later than ten (10) years after the Effective Date. Upon thirty (30) calendar days written notice from Licensor, Licensor may terminate this Agreement if Licensee fails to initiate a Phase III Clinical Trial in the intended patient population of node positive, HER2 1+ and/or 2+ breast cancer in the United States, the European Union, Eastern Europe, Japan, India, China, or other country(ies) as may be mutually agreed by the Parties hereto on or before December 31, 2012, unless before the end of such thirty (30) calendar day period, Licensee provides evidence satisfactory to Licensor that it has initiated the Phase III Clinical Trial. For the avoidance of doubt, Licensee must initiate a Phase III Clinical Trial on or before December 31, 2012 unless specifically requested or demanded otherwise by a strategic collaborative partner (identified by Licensee in writing to Licensor) or the U.S. FDA or equivalent foreign regulatory agency. The December 31, 2012 deadline may be extended as follows:
               (i) At the election of the Licensee, prior to the December 31, 2012 deadline, Licensee may pay to Licensor a [* * *] extension fee (the “Option 1 Fee”) and receive a six (6) month extension of the December 31, 2012 deadline (as extended, the “Option 1 Clinical Trial Date”);
               (ii) Upon Licensee’s timely payment of the Option 1 Fee and upon the mutual agreement of the Parties, prior to the Option 1 Clinical Trial Date, Licensee may pay to Licensor a [* * *] extension fee (the “Option 2 Fee”) and receive a second six (6) month extension of the Option 1 Clinical Trial Date (as extended, the “Option 2 Clinical Trial Date”);
               (iii) Upon Licensee’s timely payments of the Option 1 Fee and the Option 2 Fee and upon the mutual agreement of the Parties, prior to the Option 2 Clinical Trial Date, Licensee may pay to Licensor a [* * *] extension fee (the “Option 3 Fee”) and receive a third six (6) month extension of the Option 2 Clinical Trial Date (as extended, the “Option 3 Clinical Trial Date”).
RXi — Foundation License — Optimized E75 (Peoples)

10


 

ARTICLE V
REPORTING
     5.1 No later than sixty (60) days after December 31 of each calendar year, Licensee shall provide to the Foundation a written annual Progress Report describing progress on research and development, regulatory approvals, manufacturing, sublicensing, marketing, and sales during the most recent twelve (12) month period ended December 31 and plans for the forthcoming year. The Progress Report shall describe the status of Licensee’s efforts to develop and commercialize Licensed Product(s) or Licensed Process(es) in sufficient detail to enable the Foundation to reasonably determine whether anticipated performance and payment milestones have been met and to provide assurance that Licensee is developing Licensed Product(s) or Licensed Process(es). If multiple technologies are covered by the License hereunder, the Progress Report shall provide the information set forth above for each technology. If progress differs in any material respect from that anticipated in the plan required under Section 4.2(a), Licensee shall explain the reasons for the difference and propose a modified development plan for the Foundation’s review and approval, not to be unreasonably withheld. Licensee shall also provide any reasonable additional data the Foundation requires to evaluate Licensee’s performance.
     5.2 Licensee shall report to the Foundation the date of the first sale of Licensed Products (or use or sale of Licensed Processes) in each country within thirty (30) days of occurrence.
     5.3 Royalty Reports.
          (a) Licensee shall, commencing December 31, 2011, submit to the Foundation, within sixty (60) days after each calendar half year ending June 30 and December 31 during the term of this Agreement, a Royalty Report setting forth for such half year at least the following information:
               (i) the number of Licensed Products sold by Licensee and all sublicensees in each country;
               (ii) total dollar amount of billings, invoices, and receipts for Licensed Products sold by Licensee and all sublicensees in each country (together with an accounting for currency conversions, if any);
               (iii) an accounting for all Licensed Processes used or sold by Licensee and all sublicensees in each country;
               (iv) the calculation of Net Sales, including applicable deductions;
               (v) the amount of Non-royalty Sublicense Income received by Licensee;
RXi — Foundation License — Optimized E75 (Peoples)

11


 

               (vi) an accounting for any deduction made pursuant to Section 3.8; and
               (vii) the amount of royalty due to the Foundation for the reporting period or, if no royalties are due for any reporting period, the statement that no royalties are due.
Such Royalty Report shall be certified as correct by an officer of Licensee and shall include a detailed listing of all deductions from royalties otherwise due pursuant to this Agreement.
          (b) Contemporaneous with the submission of each Royalty Report, Licensee shall pay to the Foundation the amount of royalty due with respect to such half year. If multiple technologies are covered by the License granted hereunder, Licensee shall specify which Patent Rights are utilized for each Licensed Product and Licensed Process included in the Royalty Report.
          (c) Late payments shall be subject to a charge of one and one-half percent (1-1/2%) per month, or $250, whichever is greater.
     5.4 In the event of an acquisition, merger, change of corporate name, or change of organization or identity, Licensee shall notify the Foundation in writing within thirty (30) days of such event.
     5.5 If Licensee or any Affiliate or sublicensee (or optionee) does not qualify or ceases to qualify as a “small entity” as provided by the United States Patent and Trademark Office, Licensee shall notify the Foundation immediately.
ARTICLE VI
RECORD KEEPING
     6.1 Licensee shall keep, and shall require its sublicensees to keep, accurate records (together with supporting documentation) of Licensed Products and Licensed Processes made, used or sold under this Agreement, appropriate to determine the amount of royalties due to the Foundation hereunder. Such records shall be retained for at least three (3) years following the end of the reporting period to which they relate. They shall be available during normal business hours, on not less than ten (10) days’ prior notice from the Foundation, for examination by an accountant selected by the Foundation, for the sole purpose of verifying reports and payments hereunder, provided that the Foundation shall have the right to conduct such an examination not more than once in any calendar year and only with respect to prior years that have not previously been subject to such examination. In conducting examinations pursuant to this section, the Foundation’s accountant shall have access to all records that the Foundation reasonably believes to be relevant to the calculation of royalties and other payments required under Article III.
RXi — Foundation License — Optimized E75 (Peoples)

12


 

     6.2 The Foundation’s accountant shall not disclose to the Foundation any information other than information relating to the accuracy of reports and payments made hereunder. In cases of inaccurate reports and payment, Licensee shall promptly pay the Foundation any additional sum that would have been payable to the Foundation had the Licensee reported correctly, plus interest on said sum at the rate of one and one half percent (1-1/2%) per month.
     6.3 Such examination by the Foundation’s accountant shall be at the Foundation’s expense, except that if such examination shows an underreporting or underpayment in excess of the greater of (i) five percent (5%) or (ii) Ten Thousand Dollars ($10,000) for any twelve (12) month period, then Licensee shall pay the Foundation the reasonable cost of such examination (as well as any additional sum that would have been payable to the Foundation had the Licensee reported correctly, plus interest on said sum at the rate of one and one half percent (1-1/2%) per month). In addition, if such examination shows an underreporting or underpayment in excess of fifteen percent (15%) or more for any calendar year period, then in addition to the above, Licensee shall pay the Foundation an underpayment penalty fee equal to twenty-five percent (25%) of the amount of the additional sum that would have been payable to the Foundation had the Licensee reported correctly.
ARTICLE VII
DOMESTIC AND FOREIGN PATENT FILING AND MAINTENANCE
     7.1 Patent 1 Patent Rights.
          (a) Licensee Prosecution
               (i) Foundation grants Licensee the right to be responsible for the preparation, filing, prosecution and maintenance of any and all Patent Rights that relate to the intellectual property described under the “Patent 1” heading of Appendix A (“the Patent 1 Patent Rights”). Licensee agrees to prosecute and maintain at Licensee’s expense the patent applications listed under the “Patent 1” heading of Appendix A. Licensee further agrees to file at Licensee’s expense any additional continuation or divisional application(s) required to retain all embodiments of Patent 1 Patent Rights contained in said patent applications. Licensee agrees not to abandon or otherwise undermine prosecution of any Patent 1 Patent Rights without the prior written approval of the Foundation.
               (ii) Licensee shall consult with the Foundation as to the preparation, filing, prosecution and maintenance of the Patent 1 Patent Rights and agrees to keep the Foundation promptly and fully informed of the course of patent prosecution of the Patent 1 Patent Rights, by providing the Foundation with copies of all documents relevant to any such preparation, filing, prosecution, or maintenance, including but not limited to substantive communications and notices, search reports, third party observations submitted to or received from patent offices throughout the Territory,
RXi — Foundation License — Optimized E75 (Peoples)

13


 

foreign patent applications, Office Actions and Examination Reports from patent offices, and proposed draft responses. The Foundation shall have the right to review all such documents, prior to their submission, and may offer recommendations to Licensee to amend such contemplated preparation, filing, prosecution, or maintenance, and provide a list of the countries where the Foundation desires Licensee to file patent applications. Licensee will make a reasonable effort to implement such Foundation recommendations, provided the Foundation recommendations are acceptable to outside patent counsel and are received in sufficient time to meet any pertinent deadlines. The Foundation shall provide such patent consultation to Licensee at no cost to Licensee.
               (iii) In the event the Licensee elects not to, or fails to, continue prosecution, in whole or in part, of any Patent 1 Patent Rights in any particular country or countries, the Foundation shall have the right (but not the obligation) at its own expense to undertake the prosecution and maintenance of the Patent 1 Patent Rights. The Licensee shall notify the Foundation in writing of any election not to pursue the prosecution or maintenance of any Patent 1 Patent Rights at least sixty (60) days prior to any applicable deadline or loss of rights .
                    (A) Licensee shall have an obligation to pay a royalty on Net Sales of Licensed Products or Licensed Processes in any country in which Licensee discontinued prosecuting or abandoned Patent 1 Patent Rights. In addition, Licensee shall reimburse Foundation for all patent prosecution expenses that Foundation reasonably incurs pursuant to its election to prosecute Patent 1 Patent Rights under this Section 7.1(a)(iii) in any country in which Licensee has Net Sales.
               (iv) Foundation shall provide reasonable efforts to aid Licensee in obtaining signatures or inventor assistance as necessary to further prosecution and to secure the full protection and ownership of all rights in and to the Licensed Products and the Licensed Processes, but Licensee acknowledges that inventors include employees of the U.S. Government and other individuals, none of whom are employed by the Foundation.
          (b) After execution of this Agreement and within thirty (30) days of the Foundation’s submission of an invoice, Licensee shall reimburse the Foundation for [* * *], which is the total of all third party expenses the Foundation has incurred and paid prior to the Effective Date for the preparation, filing, prosecution, and maintenance of Patent 1 Patent Rights. If expenses are incurred by Foundation after the Effective Date that are reimbursable by Licensee under the terms hereof, the Licensee shall reimburse the Foundation for all such future third party expenses within thirty (30) days after Licensee’s receipt of invoices from the Foundation. Payment of these invoices that is made more than the number of days specified above after submission shall be considered late and subject to interest charges of one and one-half percent (1-1/2%) per month.
          (c) The Foundation and Licensee shall cooperate fully in the preparation, filing, prosecution and maintenance of Patent 1 Patent Rights licensed to Licensee hereunder, executing all papers and instruments or requiring employees or
RXi — Foundation License — Optimized E75 (Peoples)

14


 

agents to execute such papers and instruments so as to enable the Foundation or Licensee to apply for, to prosecute, and to maintain patent applications and patents in the Foundation’s name in any country. Each Party shall provide to the other prompt notice as to all matters that come to its attention and that may affect the preparation, filing, prosecution, or maintenance of any such patent applications or patents.
          (d) Licensee may elect to surrender its Patent 1 Patent Rights in any country upon sixty (60) days written notice to the Foundation. Such notice shall not relieve Licensee from responsibility for Patent 1 Patent Right-related expenses incurred prior to the expiration of the sixty (60)-day notice period (or such longer period specified in Licensee’s notice).
     7.2 Patent 2 Patent Rights
          (a) The Foundation, in its sole discretion, shall be responsible for the preparation, filing, prosecution, and maintenance of any and all patent applications and patents relating to the intellectual property described under the “Patent 2” heading of Appendix A (the “Patent 2 Patent Rights”), and Licensee shall be responsible for [* * *] of the expenses incurred by the Foundation for such preparation, filing, prosecution, and maintenance (all of such expenses constituting the “Patent 2 Patent Expenses”). The Foundation shall consult with Licensee as to the preparation, filing, prosecution and maintenance of such patent applications and patents and shall furnish to Licensee copies of documents relevant to any such preparation, filing, prosecution, or maintenance.
          (b) After execution of this Agreement and within thirty (30) days of the Foundation’s submission of an invoice, Licensee shall reimburse the Foundation for [* * *], which is [* * *] of all third party expenses the Foundation has incurred and paid prior to the Effective Date for the preparation, filing, prosecution, and maintenance of Patent 2 Patent Expenses. Thereafter, Licensee shall reimburse the Foundation for [* * *] of all subsequently incurred Patent 2 Patent Expenses within thirty (30) days after Licensee’s receipt of invoices from the Foundation. Late payment of these invoices shall be subject to interest charges of one and one-half percent (1 1/2%) per month.
          (c) The Foundation and Licensee shall cooperate fully in the preparation, filing, prosecution and maintenance of Patent 2 Patent Rights licensed to Licensee hereunder, executing all papers and instruments or requiring employees or agents to execute such papers and instruments so as to enable the Foundation to apply for, to prosecute, and to maintain patent applications and patents in the Foundation’s name in any country. Each Party shall provide to the other prompt notice as to all matters that come to its attention and that may affect the preparation, filing, prosecution, or maintenance of any such patent applications or patents.
          (d) Licensee may elect to surrender its Patent 2 Patent Rights in any country upon sixty (60) days written notice to the Foundation. Such notice shall not relieve Licensee from responsibility to reimburse the Foundation for [* * *] of Patent 2 Patent Expenses incurred prior to the expiration of the sixty (60)-day notice period (or such longer period specified in Licensee’s notice).
RXi — Foundation License — Optimized E75 (Peoples)

15


 

ARTICLE VIII
INFRINGEMENT
     8.1 With respect to any Patent Rights that are exclusively licensed to Licensee pursuant to this Agreement, Licensee shall have the right, within the Territory, to prosecute in its own name and at its own expense any infringement of such patent, so long as such License is exclusive at the time of the commencement of such action. The Foundation agrees to notify Licensee promptly of each infringement of such patents of which the Foundation is or becomes aware. Before Licensee commences an action with respect to any infringement of such patents, Licensee shall give careful consideration to the views of the Foundation and to potential effects on the public interest in making its decision whether or not to sue.
          (a) If Licensee elects to commence an action as described above, Foundation may, to the extent permitted by law and at the Foundation’s own expense, elect to join as a party in that action. Regardless of whether the Foundation elects to join as a party, the Foundation shall cooperate fully with Licensee in connection with any such action.
          (b) If the Foundation elects to join as a party pursuant to subsection (a), the Foundation shall jointly control the action with Licensee.
     8.2 If Licensee elects to commence an action as described above, Licensee may deduct from its royalty payments to the Foundation with respect to the patent(s) subject to suit an amount not exceeding [* * *] of Licensee’s expenses and costs of such action, including reasonable attorneys’ fees; provided, however, that such reduction shall not exceed [* * *] of the total royalty due to the Foundation with respect to the patent(s) subject to suit for each calendar year. If such [* * *] of Licensee’s expenses and costs exceeds the amount of royalties deducted by Licensee for any calendar year, Licensee may to that extent reduce the royalties due to the Foundation from Licensee in succeeding calendar years, but never by more than [* * *] of the total royalty due in any one year with respect to the patent(s) subject to suit.
     8.3 No settlement, consent, judgment or other voluntary final disposition of the suit may be entered into without the prior written consent of the Foundation, which consent shall not be unreasonably withheld or delayed.
     8.4 Recoveries or reimbursements from actions commenced pursuant to this Article shall first be applied to reimburse Licensee and the Foundation for litigation costs (excluding Licensee litigation costs deducted from royalty payments pursuant to Section 8.2) not paid from royalties and then to reimburse the Foundation for royalties deducted by Licensee pursuant to Section 8.2. Licensee and the Foundation shall share any remaining recoveries or reimbursements [* * *].
     8.5 If Licensee elects not to exercise its right to prosecute an infringement of the Patent Rights pursuant to this Article, the Foundation may do so at its own expense,
RXi – Foundation License – Optimized E75 (Peoples)

16


 

controlling such action and retaining all recoveries therefrom. Licensee shall cooperate fully with the Foundation in connection with any such action.
     8.6 Without limiting the generality of Section 8.5, the Foundation may, at its election and by notice to Licensee, establish a time limit of sixty (60) days for Licensee to decide whether to prosecute any infringement of which the Foundation is or becomes aware. If, by the end of such sixty (60)-day period, Licensee has not commenced such an action, the Foundation may prosecute such an infringement at its own expense, controlling such action and retaining all recoveries therefrom. With respect to any such infringement action prosecuted by the Foundation in good faith, Licensee shall pay over to Foundation any payments (whether or not designated as “royalties”) made by the alleged infringer to Licensee under any existing or future sublicense authorizing Licensed Products or Licensed Processes, up to the amount of the Foundation’s unreimbursed litigation expenses (including, but not limited to, reasonable attorneys’ fees).
     8.7 If a declaratory judgment action is brought naming Licensee as a defendant and alleging invalidity of any of the Patent Rights, the Foundation may elect to take over the sole defense of the action at its own expense. Licensee shall cooperate fully with the Foundation in connection with any such action.
     8.8 During the exclusive period of the Licensee’s License hereunder, Licensee shall have the sole right, in accordance with the terms and conditions hereof, to sublicense any alleged infringer within the Territory for the Field. Any upfront fees paid in connection with such sublicense shall be shared [* * *] between Licensee and the Foundation; other royalties shall be treated in accordance with Article III.
ARTICLE IX
TERMINATION OF AGREEMENT
     9.1 This Agreement, unless terminated as provided herein, shall remain in effect until the last patent or patent application in Patent Rights has expired or been abandoned.
     9.2 The Foundation may terminate this Agreement in the circumstances set forth in this Section, and any such termination shall be effective immediately upon the Foundation giving written notice to Licensee of any of the following:
          (a) if Licensee does not make a payment due hereunder and fails to cure such non-payment (including the payment of interest in accordance with Section 5.3(c)) within thirty (30) days after the date of notice in writing of such non-payment by the Foundation;
          (b) if Licensee defaults in any of its material obligations under Sections 10.4(c), 10.4(d), and 10.4(e) to procure and maintain insurance;
RXi – Foundation License – Optimized E75 (Peoples)

17


 

          (c) at any time after two (2) years from the Effective Date of this Agreement, the Foundation may, in its sole discretion, either terminate this Agreement and the License granted hereunder or render the exclusive portion of the License non-exclusive if, in the Foundation’s reasonable judgment, the Progress Reports furnished by Licensee do not demonstrate that Licensee has:
               (i) either (A) put the licensed subject matter into commercial use in the Territory, directly or through a sublicense, and is keeping the licensed subject matter continuously available to the public, or (B) has been and continues to be engaged in research, development, manufacturing, marketing or sublicensing activity appropriate to achieving the purposes set forth in Section 4.1; and
               (ii) met all relevant performance milestone(s) for the period covered by the most recent Progress Report and all preceding Progress Reports, or the Parties have mutually agreed in writing on a plan for meeting such milestone within twelve (12) months thereafter;
          (d) if Licensee: is unable to pay its debts as such debts become due; makes a general assignment for the benefit of creditors; has a petition in bankruptcy or a suit seeking reorganization, liquidation, dissolution, or similar relief filed against it and such petition or suit is not dismissed within sixty (60) days of its filing; or files or permits the filing of any petition or answer seeking to adjudicate itself bankrupt or insolvent, or seeking for itself any liquidation, winding up, reorganization, arrangement, adjustment, protection, relief, or composition of Licensee or its debts under any law relating to bankruptcy, insolvency, or reorganization or relief of debtors, or seeking or consenting to the appointment of a trustee, custodian, receiver, liquidator or other similar official for Licensee or for any substantial part of its property; or takes any corporate action to authorize any of the foregoing actions;
          (e) if an examination by Foundation’s accountant pursuant to Article VI shows a willful or intentionally fraudulent underreporting or underpayment by Licensee in excess of fifteen percent (15%) for any twelve (12) month period;
          (f) if Licensee is convicted of a felony relating to the manufacture, use, or sale of any Licensed Product or Licensed Process; or
          (g) except as provided in subsections (a), (b), (c), (d), (e) and (f) above, if Licensee defaults in the performance of any obligations under this Agreement and the default has not been remedied within ninety (90) days after the date of notice in writing of such default by the Foundation.
     9.3 Licensee shall provide, in all sublicenses granted by it under this Agreement, that Licensee’s interest in such sublicenses shall at the Foundation’s option terminate or be assigned to the Foundation upon termination of this Agreement.
     9.4 This Agreement may be terminated at any time by mutual written agreement between the Parties, subject to any terms herein which survive termination. Upon termination, Licensee shall submit a final Royalty Report to the Foundation and
RXi — Foundation License — Optimized E75 (Peoples)

18


 

any royalty payments, including royalty payments on any and all future sales of Licensed Products made but not yet sold at the time of termination, and unreimbursed patent expenses invoiced under this Agreement by the Foundation prior to termination shall become immediately payable.
     9.5 Upon termination, Licensee shall promptly provide to Foundation all data, including all pre-clinical data, clinical data, manufacturing data, and marketing data, derived during development or attempted development of Licensed Products or Licensed Processes. Licensee shall also provide to Foundation copies of all FDA submissions and correspondence related to Licensed Products or Licensed Processes. In addition, Licensee shall promptly provide Foundation the entire official file wrapper concerning prosecution of Patent 1 whether from outside counsel or internal counsel.
     9.6 Upon termination, Licensee grants to Foundation a nonexclusive royalty-bearing license with the right to sublicense with respect to improvements made by Licensee (including improvements licensed by Licensee from third parties to the extent Licensee has the right to grant such sublicenses). Licensee and Foundation agree to negotiate in good faith the royalty rate for such nonexclusive license. Foundation’s right to sublicense others hereunder is solely for the purpose of permitting others to develop and commercialize the entire technology related to the subject matter of this Agreement.
     9.7 Articles I and VI and Sections 2.5, 5.3 (only as it relates to any overdue Royalty Report(s) and to the Royalty Report for the half year during which the termination occurs), 7.2, 8.3, 8.4, 9.5, 9.6, 9.7, 10.1 through 10.8 inclusive, 10.10, 10.11, and 10.13 through 10.20 inclusive shall survive any expiration or termination of this Agreement indefinitely. Additionally, any rights or remedies arising out of a breach or violation of any terms of this Agreement will survive any expiration or termination of this Agreement. The expiration or termination of this Agreement shall not discharge either Party from any obligation that it owes to the other Party by reason of any loss, cost, damage, expense, liability, or contractual duty that occurs or arises (or the circumstances, events, or basis of which occurs or arises) prior to such expiration or termination, and shall not affect the right of either Party to institute or maintain any action for damages relating to any breach of this Agreement by the other Party prior to the date of termination. It is the intent of the Parties that any such obligation owed by a Party to the other Party arising before the date of expiration or termination (whether the same shall be known or unknown at such date, or whether the circumstances, events, or basis of the same shall be known or unknown at such date), including royalty obligations (computed in accordance with Article III) on sales made or ordered prior to the date of termination or expiration, indemnification obligations, and confidentiality obligations, shall survive the expiration or termination of this Agreement.
RXi — Foundation License — Optimized E75 (Peoples)

19


 

ARTICLE X
MISCELLANEOUS PROVISIONS
     10.1 Rules of Construction. This Agreement is to be interpreted in accordance with the following rules of construction:
               (a)  Number and Gender . All definitions of terms apply equally to both the singular and plural forms of the terms defined. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine, and neuter forms.
               (b)  Including; Herein; Etc . The words “include,” “includes,” and “including” are deemed to be followed by the phrase “without limitation.” The words “herein,” “hereof,” and “hereunder” and words of similar import refer to this Agreement (including all Appendices) in its entirety and are not limited to any part hereof, unless the context shall otherwise require. The word “or” is not exclusive and means “and/or.”
               (c)  Sales . The terms “sold,” “sell,” and “sale(s)” include leases and other transfers and similar transactions for consideration.
               (d)  Subdivisions and Attachments . All references in this Agreement to Articles, Sections, subsections, paragraphs, and Appendices are, respectively, references to Articles, Sections, subsections, and paragraphs of, and Appendices to, this Agreement, unless otherwise specified.
               (e)  References to Documents and Laws . All references to this Agreement or any Appendix hereof are to it as amended, modified, and supplemented from time to time in accordance with the terms of this Agreement. All references to (i) any other agreement or instrument or (ii) any statute, law, regulation, permit, or similar item are to it as amended and supplemented from time to time (and, in the case of a statute, law or regulation, to any corresponding provisions of successor statutes, laws, or regulations), unless otherwise specified.
               (f)  References to Days . Any reference in this Agreement to a “day” or number of “days” (without the explicit qualification “Business”) is a reference to a calendar day or number of calendar days. If any action or notice is to be taken or given on or by a particular calendar day, and such calendar day is not a Business Day, then such action or notice may be taken or given on the next Business Day.
               (g)  Examples . If, in any provision of this Agreement any example is given (through the use of the words “such as,” “for example,” “ e.g .,” or otherwise) of the meaning, intent, or operation of any provision of this Agreement, such example is intended to be illustrative only and not exclusive.
RXi — Foundation License — Optimized E75 (Peoples)

20


 

               (h)  Currency . Except as expressly provided herein, all prices or other monetary amounts stated in this Agreement are, and all monetary amounts stated in any report to be delivered pursuant hereto shall be, stated in United States Dollars.
               (i)  Participation in Drafting . Both Parties and their respective legal counsel have participated, or had the opportunity to participate, in the drafting of this Agreement, and this Agreement will be construed simply and according to its fair meaning and not strictly for or against either Party.
     10.2 Representations and Warranties .
               (a) Each Party covenants, represents, and warrants to the other Party that: it is a corporation duly organized and validly existing under the laws of the jurisdiction in which it is incorporated; this Agreement is legally binding upon it and enforceable in accordance with its terms; and the execution, delivery and performance of this Agreement does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any governmental or regulatory authority having jurisdiction over it.
               (b) Foundation further covenant, represent, and warrant to Licensee that:
                    (i) Foundation is the sole owner of the Patent Rights and has the right to grant the License to Licensee as set forth in this Agreement;
                    (ii) Foundation has not granted any rights in the Licensed Patents or the Licensed Process that are inconsistent with or that limit the rights granted to Licensee under this Agreement; and
                    (iii) Foundation is not aware that any of the Licensed Patents or the Licensed Process infringes the rights of any third party.
               (c) Foundation does not warrant the validity of the Patent Rights licensed hereunder and makes no representations whatsoever with regard to the scope of the licensed Patent Rights or that such Patent Rights may be exploited by Licensee or any sublicensee without infringing other patents.
               (d) EXCEPT AS EXPRESSLY PROVIDED IN SECTION 10.2(a) AND (b), FOUNDATION EXPRESSLY DISCLAIMS ANY AND ALL IMPLIED AND EXPRESS WARRANTIES AND MAKES NO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF THE PATENT RIGHTS, OR INFORMATION SUPPLIED BY THE FOUNDATION, OR OF THE LICENSED PROCESSES OR LICENSED PRODUCTS CONTEMPLATED BY THIS AGREEMENT.
     10.3 Limitation of Liability. IN NO EVENT SHALL ANY PARTY BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES (INCLUDING DAMAGES FOR LOSS OF PROFITS OR EXPECTED
RXi — Foundation License — Optimized E75 (Peoples)

21


 

SAVINGS OR OTHER ECONOMIC LOSSES, OR FOR INJURY TO PERSONS OR PROPERTY) ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER SUCH PARTY KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES. THE FOUNDATION’S AGGREGATE LIABILITY FOR ALL DAMAGES OF ANY KIND RELATING TO THIS AGREEMENT OR ITS SUBJECT MATTER SHALL NOT EXCEED THE AMOUNT PAID BY LICENSEE TO THE FOUNDATION UNDER THIS AGREEMENT. The foregoing exclusions and limitations shall apply to all claims and actions of any kind, whether based on contract, tort (including but not limited to negligence), or any other grounds.
     10.4 Indemnification and Insurance .
          (a) Licensee shall indemnify, defend and hold harmless the Foundation and its current and former directors, board members, trustees, officers, employees, and agents and their respective successors, heirs and assigns (collectively, the “Indemnitees”), from and against any and all claims, liabilities, costs, expenses, damages, deficiencies, losses or obligations of any kind or nature (including reasonable attorneys’ fees and other costs and expenses of litigation) (collectively “Claims”) based upon, arising out of, or otherwise relating to this Agreement, including without limitation any cause of action relating to product liability concerning any product, process, or service made, used, or sold pursuant to any right or license granted under this Agreement.
          (b) Licensee shall, at its own expense, provide attorneys reasonably acceptable to the Foundation to defend against any actions brought or filed against any Indemnitee(s) hereunder with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought.
          (c) Beginning at the time any such product, process or service is being commercially distributed or sold (other than for the purpose of obtaining regulatory approvals) by Licensee or by any sublicensee or agent of Licensee, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts not less than $2,000,000 per incident and $4,000,000 annual aggregate and naming the Indemnitees as additional insureds. During clinical trials of any such product, process, or service, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in such equal or lesser amount as the Foundation shall require, naming the Indemnitees as additional insureds. Such commercial general liability insurance shall provide (i) product liability coverage and (ii) broad form contractual liability coverage for Licensee’s indemnification under this Agreement. If Licensee elects to self-insure all or part of the limits described above (including deductibles or retentions that are in excess of $250,000 annual aggregate) such self-insurance program must be acceptable to the Foundation in its sole discretion. The minimum amounts of insurance coverage required shall not be construed to create a limitation of Licensee’s liability with respect to its indemnification under this Agreement.
          (d) Licensee shall provide the Foundation with written evidence of such insurance upon request of the Foundation. Licensee shall provide the Foundation
RXi — Foundation License — Optimized E75 (Peoples)

22


 

with written notice at least fifteen (15) days prior to the cancellation, non-renewal, or material change in such insurance; if Licensee does not obtain replacement insurance providing comparable coverage within such fifteen (15) day period, the Foundation shall have the right to terminate this Agreement effective at the end of such fifteen (15) day period without notice or any additional waiting periods.
          (e) Licensee shall maintain such commercial general liability insurance beyond the expiration or termination of this Agreement during (i) the period that any product, process, or service, relating to, or developed pursuant to, this Agreement is being commercially distributed or sold by Licensee or by a sublicensee or agent of Licensee and (ii) a reasonable period, but in no event less than five (5) years, after the period referred to in clause (i), above.
     10.5 Limitation on Advertising and Publicity . Except as required by law, including applicable rules and regulations of the U.S. Securities and Exchange Commission and stock exchange listing requirements, Licensee shall not use the Foundation’s or USU’s name or insignia, or the name or insignia of the U.S. Government or any agency thereof, or any adaptation of the foregoing, or the name of any of Foundation’s or USU’s inventors, in any press release, public announcement, advertising, promotional, or sales literature without the prior written approval of the Foundation or USU, as the case may be.
     10.6 Assignment . Neither this Agreement nor the rights granted hereunder shall be transferred or assigned in whole or in part by Licensee to any person, whether voluntarily or involuntarily, by operation of law, or otherwise, without the prior written consent of the Foundation, which will not unreasonably be withheld or delayed. Notwithstanding the foregoing, this Agreement and Licensee’s rights hereunder may be assigned or transferred to an entity that acquires all or substantially all of the assets or business of Licensee or Licensee’s business unit holding the License, whether through merger, sale of stock, sale of assets, reorganization, or otherwise. This Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors, legal representatives, and permitted assignees.
     10.7 Governing Law . This Agreement shall be governed by and construed and interpreted in accordance with the laws of the State of Maryland, as to all matters, including matters of validity, construction, effect, performance, and remedies, irrespective of any contrary choice of law that otherwise would be applicable under the choice of laws principles of any jurisdiction.
     10.8 Compliance with Laws and Regulations . Licensee shall comply with all applicable laws and regulations, including United States laws and regulations controlling exports. Licensee agrees that it will be solely responsible for any violation of applicable laws or regulations by Licensee or its Affiliates or sublicensees, and that it will defend and hold the Foundation harmless in the event of any legal action of any nature occasioned by such violation.
RXi — Foundation License — Optimized E75 (Peoples)

23


 

     10.9 Regulatory Approvals; Patent Markings . Licensee agrees (i) to obtain all regulatory approvals required for the manufacture and sale of Licensed Products and Licensed Processes and (ii) to utilize appropriate patent marking on such Licensed Products. Licensee also agrees to register or record this Agreement as is required by law or regulation in any country where the License is in effect.
     10.10 Confidential Information and Intellectual Property . Except as specifically required to comply with obligations set forth in this Agreement, neither Party shall be obligated to disclose or furnish to the other Party any Confidential Information of such first Party or any confidential or proprietary information, technology, or intellectual property of any third party in such first Party’s possession or control. If, however, the Parties have heretofore entered or hereafter enter into a confidential information nondisclosure agreement or similar agreement (the “NDA”), neither Party may terminate the NDA prior to the termination or expiration of this Agreement. If the Parties have not entered into an NDA, each Party agrees, for the greater of a period of five (5) years after each disclosure or during the pendency of this Agreement, to maintain in confidence all Confidential Information disclosed to it by the other Party and to protect such Confidential Information by using the same degree of care, but no less than a reasonable degree of care, as the receiving Party uses to protect its own similar confidential information.
     10.11 Headings . The article, section, and other headings contained in this Agreement are for reference purposes only and are not intended to describe, interpret, define, or limit the scope, extent, or intent of this Agreement.
     10.12 Counterpart Execution . This Agreement and any modification or amendment thereof may be executed in counterparts, including counterparts transmitted by electronic mail or facsimile transmission, all of which shall be considered one and the same agreement, and shall become effective when such counterparts have been signed by each of the Parties and delivered to the other Party.
     10.13 Waivers; Remedies Generally . The observance of any term of this Agreement may be waived (whether generally or in a particular instance and either retroactively or prospectively) by the Party entitled to enforce such term, but any such waiver will be effective only if in a writing signed by the Party against which such waiver is to be asserted. Except as otherwise provided in this Agreement, no failure or delay of either Party in exercising any power, right, or remedy under this Agreement will operate as a waiver thereof, nor will any single or partial exercise of any such right, power, or remedy, preclude any other or further exercise thereof or the exercise of any other right, power, or remedy. A waiver by either Party shall be limited to the specific instance in which it is given and, therefore, any waiver by either Party of any obligation of the other Party under or breach by the other Party of this Agreement or of any power, right, or remedy of the waiving Party shall not be a waiver of any other obligation or further or future performance of the same obligation, of any other or succeeding breach, of any other or further exercise of such power, right, or remedy or any other power, right, or remedy.
RXi — Foundation License — Optimized E75 (Peoples)

24


 

     10.14 Severability . To the extent that any provision of this Agreement shall be judicially unenforceable in any one or more jurisdictions, such provision shall not be affected with respect to any other jurisdiction, each provision with respect to each jurisdiction being construed as several and independent. If any term or provision of this Agreement or the application thereof to any person or circumstance is, to any extent, declared or found to be illegal, unenforceable, or void, then both Parties will be relieved of all obligations arising under such term or provision, but only to the extent that such term or provision is illegal, unenforceable, or void, it being the intent and agreement of the Parties that this Agreement will be deemed amended by modifying such term or provision to the extent necessary to make it legal and enforceable while preserving its intent or, if that is not possible, by substituting therefor another term or provision that is legal and enforceable and achieves the same objective. If the remainder of this Agreement will not be affected by such declaration or finding and is capable of substantial performance, then each term and provision not so affected will be enforced to the extent permitted by law. If necessary to effect the intent of the Parties, the Parties will negotiate in good faith to amend this Agreement to replace the unenforceable language with enforceable language that as closely as possible reflects such intent and to amend any other term or provision thereby rendered incapable of substantial performance or otherwise affected thereby to the extent necessary to permit the practical realization, insofar as legally possible, of the intent of the Parties.
     10.15 Relationship of the Parties; Disclaimer of Agency .
          (a)  Independent Contractors . In entering into and carrying out this Agreement, the Parties will be acting solely as independent contractors. Nothing in this Agreement creates, has created, or will create any partnership, joint venture, or other business association between the Parties, nor any duties or responsibilities of partners, venturers, or members of a business association.
          (b)  No Agency . Except for provisions in this Agreement expressly authorizing one Party to act for the other, this Agreement will not constitute either Party as a legal representative or agent of the other Party, nor will either Party have the right or authority to assume, create, or incur any liability or any obligation of any kind, expressed or implied, against or in the name or on behalf of the other Party unless otherwise expressly permitted by such Party.
     10.16 No Third Party Beneficiaries . The representations, warranties, covenants, and undertakings contained in this Agreement are for the sole benefit of the Parties, their sublicensees, and the Parties’ permitted successors and assigns and shall not be construed as creating any third party beneficiaries of this Agreement or as conferring any rights whatsoever on any third party.
     10.17 Notices . Unless otherwise expressly agreed by the Party receiving notice, any notice, demand, or other communication required or permitted to be given by either Party under any provision of this Agreement must be in writing, in the English language, and mailed (certified or registered mail, postage prepaid, return receipt requested) or sent
RXi — Foundation License — Optimized E75 (Peoples)

25


 

by hand or overnight courier, or by facsimile (with acknowledgment received), charges prepaid and addressed to the intended recipient at such Party’s address set forth below, or to such other address or number as such Party may from time to time specify by notice to the other Party as provided in this Section. All notices and other communications given in accordance with the provisions of this Agreement will be deemed to have been given and received (i) when actually delivered by hand, by mail, or by courier, or (ii) when transmitted by facsimile (with acknowledgment received and a copy of such notice is sent no later than the next Business Day by a reliable overnight or two-day courier service, with acknowledgment of receipt).
     If to RXi:
RXi Pharmaceuticals Corporation
ATTN: President and CEO
60 Prescott Street
Worcester, MA 01605
Fax: 508-767-3862
     If to Apthera:
Apthera, Inc.
ATTN: President and CEO
60 Prescott Street
Worcester, MA 01605
Fax: 508-767-3862
     If to the Foundation:
The Henry M. Jackson Foundation for
    the Advancement of Military Medicine, Inc.
ATTN: General Counsel
1401 Rockville Pike, Suite 600
Rockville, MD 20852
Fax: 301-294-8130
     10.18 Disputes . In the event of any controversy or claim arising out of or relating to any provision of this Agreement or the breach thereof, the Parties shall try to settle such conflict amicably. Subject to the limitation stated in the final sentence of this Section, any such conflict that the Parties are unable to resolve promptly shall be settled through arbitration conducted in accordance with the rules of the American Arbitration Association. The demand for arbitration shall be filed within a reasonable time after the controversy or claim has arisen, and in no event after the date upon which institution of legal proceedings based on such controversy or claim would be barred by the applicable statute of limitations. Such arbitration shall be held in Montgomery County, Maryland. The award through arbitration shall be final and binding. Either Party may enter any such award in a court having jurisdiction or may make application to such court for judicial
RXi — Foundation License — Optimized E75 (Peoples)

26


 

acceptance of the award and an order of enforcement, as the case may be. Notwithstanding the foregoing, either Party may, without recourse to arbitration, assert against the other Party a third-party claim or cross-claim in any action brought by a third party, to which the subject matter of this Agreement may be relevant.
     10.19 Entire Agreement; Modifications . This Agreement constitutes the complete agreement between the Parties concerning the subject matter hereof and replaces any prior oral or written communications between the Parties. There are no conditions, understandings, agreements, representations, or warranties, express or implied, that are not specified herein, and neither Party shall be obligated by any condition or representation other than those expressly stated herein or as may be subsequently agreed by the Parties in writing. Any purported modification or amendment of the express terms or provisions of this Agreement shall be effective only if contained in a written instrument signed by each Party.
     10.20 Force Majeure . No Party shall be liable to the other Party for any losses or damages to the extent and for the period of time that they are attributable to a default or breach of this Agreement that is the result of war (whether declared or undeclared), acts of God, revolution, acts of terrorism, fire, earthquake, flood, pestilence, riot, enactment of change of law following the Effective Date, accident, labor trouble, or shortage of or inability to obtain material equipment or transport or any other cause beyond the reasonable control of such Party; provided, however, that if such a cause occurs, then the Party affected will promptly notify the other Party of the nature and likely result and duration (if known) of such cause and use commercially reasonable efforts to mitigate any adverse effects under this Agreement. If the event lasts for a period longer than three (3) months, the Parties shall meet and discuss appropriate modifications to this Agreement or other remedial measures.
SIGNATURE PAGE FOLLOWS
RXi — Foundation License — Optimized E75 (Peoples)

27


 

THE FOUNDATION AND LICENSEE HAVE READ THIS AGREEMENT INCLUDING ALL APPENDICES HERETO AND AGREE TO BE BOUND BY ALL THE TERMS AND CONDITIONS HEREOF AND THEREOF.
IN WITNESS WHEREOF , the Parties have entered into this License Agreement as of the Effective Date.
         
  THE HENRY M. JACKSON FOUNDATION FOR THE
ADVANCEMENT OF MILITARY MEDICINE, INC.
 
 
  /s/ John W. Lowe    
  John W. Lowe   
  President   
 
  7/11/2011
 
Date  
 
 
  RXI PHARMACEUTICALS CORPORATION
 
 
  /s/ Mark J. Ahn, Ph.D.    
  Mark J. Ahn, Ph.D.   
  President and CEO   
 
  7/11/2011
 
Date  
 
 
  APTHERA, INC.
 
 
  /s/ Mark J. Ahn, Ph.D.    
  Mark J. Ahn, Ph.D.   
  President and CEO   
 
  7/11/2011
 
Date  
 
 
RXi — Foundation License — Optimized E75 (Peoples)

28


 

APPENDIX A
The following patent applications are included in the Patent Rights:
      Patent 1
     Title: Vaccine for the Prevention of Breast Cancer Relapse
     Inventors: Peoples and Ponniah
     as described in U.S. Provisional Application No. 60/941,524 filed on 06/01/2007; and
     as described in International Patent Application No. PCT/US2008/060044 filed on 04/11/2008, claiming priority to U.S. Provisional Application No. 60/941,524, and all corresponding National Stage Applications including but not limited to Australian Patent Application No. 2008260399 filed on 11/06/2009, Canadian Patent Application No. 2,687,368 filed on 11/16/2009, Mexican Patent Application No. MX/a/2009/012858 filed on 11/27/2009, Japanese Patent Application No. 2010-510385 and U.S. Patent Application No. 12/602,214 filed on 11/30/2009, Chinese Patent Application No. 200880018401.2 filed on 12/01/2009, European Patent Application No. 08745615.8 filed on 12/18/2009, and Korean Patent Application No. 10-2009-7027587 filed on 12/31/2009.
      Patent 2
     Title: Targeted Identification of Immunogenic Peptides
     Inventors: Peoples, Ponniah, Flora and Storrer
     as described in U.S. Provisional Application No. 60/714,865 filed on 09/08/2005; and
     as described in International Patent Application No. PCT/US2006/035171 filed on 09/08/2006, claiming priority to U.S. Provisional Application No. 60/714,865, and all corresponding National Stage Applications including but not limited to Canadian Patent Application No. 2,622,036 and U.S. Patent Application No. 12/045,402 filed on 03/10/2008, Australian Patent Application No. 2008201427 filed on 03/28/2008, and European Patent Application No. 06824918.4 and Japanese Patent Application No. 2008-530244 filed on 03/31/2008; and
     as described in International Patent Application No. PCT/GB2008/050227 filed on 03/28/2008, claiming priority to Canadian Patent Application No. 2,622,036 and U.S. Patent Application No. 12/045,402, and all corresponding National Stage Applications including but not limited to European Patent Application No. 08719072.4 filed on 10/08/2010.
RXi — Foundation License — Optimized E75 (Peoples)

29

Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Mark J. Ahn, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of RXi Pharmaceuticals Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of 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 controls over financial reporting.
Dated: August 15, 2011
         
  /s/ Mark J. Ahn    
  Mark J. Ahn   
  President and Chief Executive Officer   

 

         
Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Robert E. Kennedy, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of RXi Pharmaceuticals Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of 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 controls over financial reporting.
Dated: August 15, 2011
         
  /s/ Robert E. Kennedy    
  Robert E. Kennedy   
  Vice President and Chief Financial Officer   

 

         
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
     In connection with the Quarterly Report of RXi Pharmaceuticals Corporation. (the “Company”) on Form 10-Q for the period ended June 30, 2011 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned officers of the Company certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to their knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the Company’s financial condition and result of operations.
     
/s/ Mark J. Ahn
  /s/ Robert E. Kennedy
 
   
Mark J. Ahn
  Robert E. Kennedy
President and Chief Executive Officer
  Vice President and Chief Financial Officer
 
   
August 15, 2011
  August 15, 2011