Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form 10-Q

 

 

 

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

For the quarterly period ended March 31, 2010

OR

 

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

For the transition period from              to             

Commission File Number 001-14888

 

 

INOVIO PHARMACEUTICALS, INC.

(Exact name of Registrant as specified in its charter)

 

 

 

Delaware   33-0969592

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

1787 SENTRY PARKWAY WEST

BUILDING 18, SUITE 400

BLUE BELL, PENNSYLVANIA 19422

(Address of principal executive offices) (Zip Code)

(267) 440-4200

(Registrant’s telephone number, including area code)

Inovio Biomedical Corporation

(Former name, if changed since last report)

 

 

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

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

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

 

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

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

The number of shares outstanding of the registrant’s Common Stock, par value $0.001 per share, was 102,804,930 as of May 11, 2010.

 

 

 


Table of Contents

INOVIO PHARMACEUTICALS, INC.

FORM 10-Q

For the Quarterly Period Ended March 31, 2010

INDEX

 

Part I   

Financial Information

   3
   Item 1.   

Financial Statements

   3
      a)  

Condensed Consolidated Balance Sheets as of March 31, 2010 (Unaudited) and December 31, 2009

   3
      b)  

Condensed Consolidated Statements of Operations for each of the Three Months Ended  March 31, 2010 and 2009 (Unaudited)

   4
      c)  

Condensed Consolidated Statements of Cash Flows for each of the Three Months Ended March 31, 2010 and 2009 (Unaudited)

   5
      d)  

Notes to Condensed Consolidated Financial Statements (Unaudited)

   6
   Item 2.   

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

   16
   Item 3.   

Quantitative and Qualitative Disclosures About Market Risk

   21
   Item 4.   

Controls and Procedures

   22
Part II    Other Information    24
   Item 1.   

Legal Proceedings

   24
   Item 1A.   

Risk Factors

   24
   Item 2.   

Unregistered Sales of Equity Securities and Use of Proceeds

   38
   Item 3.   

Default Upon Senior Securities

   38
   Item 4.   

(Removed and Reserved)

   38
   Item 5.   

Other Information

   39
   Item 6.   

Exhibits

   40

Signatures

   41

 

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Table of Contents

Part I. Financial Information

 

Item 1. Financial Statements

INOVIO PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

     March 31,
2010
    December 31,
2009
 
     (Unaudited)        
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 17,710,983      $ 30,296,215   

Short-term investments—certificates of deposit

     8,000,000        —     

Short-term investments—auction rate securities

     10,836,476        10,397,530   

Auction rate security rights

     2,706,210        3,145,156   

Accounts receivable

     344,061        259,207   

Accounts receivable from affiliated entity

     3,061,207        58,853   

Prepaid expenses and other current assets

     463,562        409,845   
                

Total current assets

     43,122,499        44,566,806   

Fixed assets, net

     339,984        343,457   

Intangible assets, net

     12,487,537        12,968,934   

Goodwill

     10,113,371        10,113,371   

Investment in affiliated entity

     13,374,976        12,330,802   

Other assets

     283,478        305,547   
                

Total assets

   $ 79,721,845      $ 80,628,917   
                
LIABILITIES AND STOCKHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable and accrued expenses

   $ 2,915,220      $ 3,445,750   

Accounts payable and accrued expenses due to affiliated entity

     128,720        445,091   

Accrued clinical trial expenses

     299,313        299,261   

Line of credit

     12,097,634        12,114,760   

Common stock warrants

     1,718,492        2,774,850   

Deferred revenue

     151,532        270,326   

Deferred revenue from affiliated entity

     375,000        —     

Deferred rent

     1,917        —     
                

Total current liabilities

     17,687,828        19,350,038   

Deferred revenue, net of current portion

     72,580        82,594   

Deferred revenue from affiliated entity, net of current portion

     2,617,944        —     

Deferred rent, net of current portion

     23,844        11,338   
                

Total liabilities

     20,402,196        19,443,970   
                

Inovio Pharmaceuticals, Inc. stockholders’ equity:

    

Common stock

     102,766        102,746   

Additional paid-in capital

     238,008,428        237,577,970   

Accumulated deficit

     (179,518,119     (177,224,433

Accumulated other comprehensive income

     110,656        105,796   
                

Total Inovio Pharmaceuticals, Inc. stockholders’ equity

     58,703,731        60,562,079   

Non-controlling interest

     615,918        622,868   
                

Total stockholders’ equity

     59,319,649        61,184,947   
                

Total liabilities and stockholders’ equity

   $ 79,721,845      $ 80,628,917   
                

See accompanying notes.

 

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INOVIO PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

     Three Months Ended
March  31,
 
     2010     2009  

Revenue:

    

License fee and milestone revenue

   $ 73,610      $ 213,098   

Revenue under collaborative research and development arrangements

     —          54,458   

Grant and miscellaneous revenue

     1,299,779        101,894   
                

Total revenue

     1,373,389        369,450   

Operating expenses:

    

Research and development

     2,730,595        963,733   

General and administrative

     3,050,158        2,966,142   
                

Total operating expenses

     5,780,753        3,929,875   
                

Loss from operations

     (4,407,364     (3,560,425

Interest income, net

     34,561        33,648   

Other income, net

     1,027,993        62,282   

Gain from investment in affiliated entity

     1,044,174        —     
                

Net loss

     (2,300,636     (3,464,495

Net loss attributable to non-controlling interest

     6,950        —     
                

Net loss attributable to Inovio Pharmaceuticals, Inc.

   $ (2,293,686   $ (3,464,495
                

Loss per common share — basic and diluted:

    

Net loss per share attributable to Inovio Pharmaceuticals, Inc. stockholders

   $ (0.02   $ (0.08
                

Weighted average number of common shares outstanding — basic and diluted

     102,757,083        44,035,480   
                

See accompanying notes.

 

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INOVIO PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

     Three Months
Ended
March  31,
2010
    Three Months
Ended
March  31,
2009
 

Cash flows from operating activities:

    

Net loss

   $ (2,300,636   $ (3,464,495

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

    

Depreciation

     41,244        46,029   

Amortization of intangible assets

     481,397        181,634   

Change in value of common stock warrants

     (1,056,358     (63,953

Gain on long-term investments

     438,946        (365,111

Loss on auction rate security rights

     (438,946     365,111   

Stock-based compensation

     429,477        160,719   

Interest expense accrued on line of credit

     34,368        —     

Amortization of deferred tax liabilities

     —          (15,750

Deferred rent

     14,423        (17,774

Gain from investment in affiliated company

     (1,044,174     —     

Changes in operating assets and liabilities:

    

Accounts receivable

     (84,854     437,455   

Accounts receivable from affiliated entity

     (3,002,354     —     

Prepaid expenses and other current assets

     (53,717     35,619   

Other assets

     22,069        —     

Accounts payable and accrued expenses

     (530,478     494,751   

Accounts payable due to affiliated entity

     (316,371     —     

Deferred revenue

     (128,808     (79,998

Deferred revenue from affiliated entity

     2,992,944        —     
                

Net cash used in operating activities

     (4,501,828     (2,285,763
                

Cash flows from investing activities:

    

Purchase of short term investments

     (8,000,000     —     

Purchases of capital assets

     (37,771     (1,094

Additions to intangible assets and other assets

     —          (62,448
                

Net cash used in investing activities

     (8,037,771     (63,542
                

Cash flows from financing activities:

    

Proceeds from stock option exercises

     1,001        —     

Repayment of line of credit

     (51,494     (37,016
                

Net cash used in financing activities

     (50,493     (37,016

Effect of exchange rate changes on cash and equivalents

     4,860        (1,722
                

Decrease in cash and equivalents

     (12,585,232     (2,388,043

Cash and cash equivalents, beginning of period

     30,296,215        14,115,281   
                

Cash and cash equivalents, end of period

   $ 17,710,983      $ 11,727,238   
                

See accompanying notes

 

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INOVIO PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1. Description of Business

Inovio Pharmaceuticals, Inc. (the “Company” or “Inovio”) is engaged in the discovery, development, and delivery of a new generation of vaccines, called DNA vaccines, focused on cancers and infectious diseases. Our SynCon™ technology enables the design of “universal” DNA-based vaccines capable of providing cross-protection against new, unmatched strains of pathogens such as influenza. The Company’s electroporation DNA delivery technology uses brief, controlled electrical pulses to increase cellular DNA vaccine uptake. Initial human data has shown this method can safely and significantly increase gene expression and immune responses. The Company’s clinical programs include human papillomavirus (“HPV”)/cervical cancer (therapeutic), avian influenza (preventative), hepatitis C virus (“HCV”) and human immunodeficiency virus (“HIV”) vaccines. The Company is advancing preclinical research for a universal seasonal/pandemic influenza vaccine. The Company’s partners and collaborators include University of Pennsylvania, National Microbiology Laboratory of the Public Health Agency of Canada, NIAID (NIH), Merck, ChronTech, University of Southampton, and HIV Vaccines Trial Network (“HVTN”).

All of the Company’s potential human products are in research and development phases. No revenues have been generated from the sale of any such products, nor are any such revenues expected for at least the next several years. The Company earns revenue from license fees and milestone revenue, collaborative research and development agreements, grants and government contracts. The Company’s product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All product candidates that the Company advances to clinical testing will require regulatory approval prior to commercial use, and will require significant costs for commercialization. The Company may not be successful in its research and development efforts and the Company may never generate sufficient product revenue to be profitable.

On May 14, 2010, we amended our Certificate of Incorporation to change our name from “Inovio Biomedical Corporation” to Inovio Pharmaceuticals, Inc.

2. Basis of Presentation

The accompanying unaudited condensed consolidated financial statements of Inovio have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The condensed consolidated balance sheet as of March 31, 2010, condensed consolidated statements of operations for the three months ended March 31, 2010 and 2009, and the condensed consolidated statements of cash flows for the three months ended March 31, 2010 and 2009, are unaudited, but include all adjustments (consisting of normal recurring adjustments) that the Company considers necessary for a fair presentation of the financial position, results of operations and cash flows for the periods presented. The results of operations for the three months ended March 31, 2010 shown herein are not necessarily indicative of the results that may be expected for the year ending December 31, 2010, or for any other period. These financial statements, and notes thereto, should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2009, included in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 26, 2010. The Company has evaluated subsequent events after the balance sheet date of March 31, 2010 through the date it filed these unaudited condensed consolidated financial statements with the SEC.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, disclosures 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 those estimates.

The Company incurred net loss attributable to Inovio of $2.3 million for the three months ended March 31, 2010. The Company had working capital of $25.4 million and an accumulated deficit of $179.5 million as of March 31, 2010. The Company’s ability to continue its operations is dependent upon its ability to obtain additional capital in the future and achieve profitable operations. On July 31, 2009, Inovio closed a $30.0 million offering of its shares of common stock and warrants to purchase shares of common stock. The Company received net proceeds from the transaction of approximately $28.4 million, after deducting offering expenses. The Company expects to continue to rely on outside sources of financing to meet its capital needs and the Company may never achieve positive cash flow. These unaudited interim condensed consolidated financial statements do not include any adjustments to the specific amounts and classifications of assets and liabilities, which might be necessary should the Company be unable to continue in

 

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INOVIO PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

(Unaudited)

 

business. The Company’s unaudited interim condensed consolidated financial statements as of and for the period ended March 31, 2010 have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business for the foreseeable future.

3. VGX Pharmaceuticals Business Acquisition

On June 1, 2009 (the “Acquisition Date”) the Company completed the acquisition of VGX Pharmaceuticals, Inc. (“VGX”), a privately-held company, pursuant to the terms of an Amended and Restated Agreement and Plan of Merger dated December 5, 2008, as further amended on March 31, 2009 (the “Merger Agreement”) by and among Inovio, Inovio’s wholly-owned subsidiary Inovio Acquisition, LLC and VGX (the “Merger”).

Upon the closing of the Merger, based on an exchange ratio of 0.9812 (the “Merger Exchange Ratio”), and on terms and conditions as set forth in the Merger Agreement,

 

   

all of the issued and outstanding shares of common stock of VGX were canceled and converted into the right to receive shares of common stock of Inovio,

 

   

all outstanding options to purchase shares of VGX common stock became exercisable for shares of Inovio’s common stock,

 

   

all outstanding warrants to purchase shares of VGX common stock became exercisable for shares of Inovio’s common stock, and

 

   

all outstanding convertible debt of VGX became debt convertible into Inovio’s common stock on existing terms.

As of the Acquisition Date, an aggregate of 41,492,757 shares of Inovio’s common stock were issued to the former stockholders of VGX, and an additional 18,794,187 shares of Inovio’s common stock were reserved for issuance upon exercise of the assumed options and warrants and conversion of the principal of and maximum interest payable on the VGX convertible debt. Immediately following the Acquisition Date the continuing holders of Inovio securities owned approximately 51.59% of Inovio’s issued and outstanding common stock and the former holders of VGX securities owned approximately 48.41% of Inovio’s issued and outstanding common stock.

Upon the closing of the Merger, Inovio Acquisition, LLC succeeded to all of VGX’s business, properties and assets and assumed its obligations (other than the outstanding options and warrants to purchase shares of VGX common stock that became exercisable to purchase shares of Inovio common stock), changed its name to VGX Pharmaceuticals, LLC, and remains a wholly-owned subsidiary of the Company, utilizing a single, integrated management team with Inovio.

Prior to the date of the Merger Agreement, Inovio’s sole relationship with VGX was as a party to a licensing agreement with VGX, entered into in the ordinary course of business, and as a holder of 25,000 shares of VGX common stock acquired in relation to such agreement. The shares of VGX common stock held by Inovio were cancelled upon closing of the Merger.

After a review of relevant factors and in accordance with the guidance regarding business combinations, Inovio was determined to be the accounting acquirer. The Merger was accounted for using the purchase method of accounting for business combinations under U.S. GAAP. Accordingly, the historical consolidated financial statements of Inovio were carried forward at their historical cost and the purchase price allocated to VGX’s identifiable assets and liabilities was based on their estimated fair values at the Acquisition Date.

The final determination of the purchase price allocation was based on the fair values of major classes of assets acquired, including identifiable intangibles, and the fair value of liabilities assumed as of the Acquisition Date. The excess purchase price of the acquired entity over the fair value of assets and liabilities was recognized by the Company as goodwill on the accompanying consolidated balance sheet.

As a result of the Merger, Inovio acquired VGX’s developed technology, which consists of VGX’s CELLECTRA ® technology and GHRH technology.

The purchase price allocation for acquisitions requires extensive use of accounting estimates and judgments to allocate the purchase price to the identifiable tangible and intangible assets acquired, including in-process research and development, and liabilities assumed based on their respective fair values. Additionally, the Company must determine whether an acquired entity is considered to be a business or a set of net assets, because a portion of the purchase price can only be allocated to goodwill in a business combination.

 

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Table of Contents

INOVIO PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

(Unaudited)

 

Management estimated the fair value of the VGX developed technology using reasonable assumptions based on historical experience. The valuation methodology used to estimate the value of the technologies was the excess earnings method. This method reflects the present value of the operating cash flows generated by the technologies after taking into account the cost to realize the revenue, and an appropriate discount rate to reflect the time value and risk associated with the assets. First, yearly revenues for each technology were forecasted for a projected period of time of 10 years. Related cost of sales and operating expenses were then deducted from the revenue stream. Next, in order to value the technology, the value and required rate of return for other assets that contribute to the generation of the revenue earned by that particular technology asset were determined. The required returns on these other assets (the other asset classes identified were: net working capital, fixed assets, and assembled workforce) were “charged to” (or rather deducted from) the future net operating income to determine the returns specifically earned by the technology. Then, a discount rate was applied that considered the reasonable expectation of the risk profile of the proprietary technology in order to bring the future income to a present value. In the case of CELLECTRA ® technology, a discount rate of 45% was used for the core technology and 60% for the milestone and royalty; for the GHRH technology, a 45% discount rate was utilized.

There was no purchase price amount allocated to acquired in-process research and development.

The percentage of non-controlling ownership interest consists of 12% in VGX Animal Health (“VGX AH”) and 88% ownership by the Company. The estimated fair value utilized is based on the last round of financing by VGX AH in late 2007, in which that entity issued shares of its common stock to a third party. There have been no subsequent financing rounds. Inovio has updated the valuation model to reflect current assumptions and due to the fact that there have been no additional milestone events, such as additional marketing approval, significant licensing agreements, material adverse events, or large sales contracts that would have materially changed any of the key assumptions used in the last valuation of VGX AH, Inovio believes that the valuation used in the last round of financing continues to reflect current fair value.

The Company’s investment in an affiliated entity represents the Company’s ownership interest in VGX International, Inc. (“VGX Int’l”) and is measured at fair value. The fair market value of the Company’s interest in VGX Int’l was determined using the closing price of VGX Int’l’s shares of common stock as listed on the Korean Stock Exchange as of June 1, 2009. The fair value of the Company’s investment in VGX Int’l and the Company’s ownership percentage of VGX Int’l were $21,575,416 and 19.65%, respectively, on June 1, 2009.

The total purchase price of the acquisition was estimated as follows:

 

Value of Inovio shares issued

   $ 26,156,188

Value of vested warrants and options assumed

     5,137,038
      
   $ 31,293,226
      

The fair value of the Inovio shares used in determining the purchase price was $0.63 per share based on the closing price of Inovio common stock on June 1, 2009.

The purchase price has been allocated to each major class of identifiable assets acquired and liabilities assumed based on their fair values as of June 1, 2009. The allocation to identifiable assets and liabilities is summarized below:

 

     Fair Value  

Identifiable assets acquired

   $ 25,012,941   

Intangible assets (developed technology)

     8,441,583   

Goodwill

     6,212,658   

Assumed liabilities

     (7,703,649

Assumed noncontrolling interest

     (670,307
        

Total

   $ 31,293,226   
        

The excess of the purchase price over the fair value of net assets acquired resulted in goodwill of approximately $6.2 million.

The following unaudited pro forma financial information combines the results of operations of Inovio and VGX assuming the Merger was consummated on January 1, 2009. The pro forma results are not necessarily indicative of what would have occurred if the Merger had been in effect for the periods presented. In addition, they are not intended to be a projection of future results and do not reflect any synergies that might be achieved from combined operations.

 

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INOVIO PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

(Unaudited)

 

     Three  Months
Ended
March 31, 2010
    Three  Months
Ended
March 31, 2009
 

Revenue

   $ 1,373,389      $ 1,756,678   

Net loss attributable to common stockholders

   $ (2,293,686   $ (6,180,169

Net loss per common share

   $ (0.02   $ (0.07

4. Principles of Consolidation

These unaudited condensed consolidated financial statements include the accounts of Inovio Pharmaceuticals, Inc. and its domestic and foreign subsidiaries. All intercompany accounts and transactions have been eliminated upon consolidation.

Reorganization

In April 2009, the Company’s Board of Directors implemented a reduction in force which impacted our Norwegian operations. In connection with this decision, operations previously performed in Norway ceased as of July 31, 2009, and are continuing in the United States. As of March 31, 2010, both of our wholly-owned Norwegian subsidiaries, Inovio AS and Inovio Tec AS, have been dissolved.

5. Marketable Securities and Fair Value Measurements

The guidance regarding fair value measurements establishes a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.

The following table presents the Company’s financial assets and liabilities that are measured at fair value on a recurring basis as of March 31, 2010:

 

     Fair Value Measurements at
March 31, 2010
     Total    Using Quoted Prices
in Active Markets
for Identical Assets
(Level 1)
   Using Significant
Other  Unobservable
Inputs
(Level 2)
   Using Significant
Unobservable
Inputs
(Level 3)

Assets:

           

Money market funds

   $ 11,288,517      11,288,517      —        —  

Certificates of deposit

     8,000,000      —        8,000,000      —  

Auction rate securities

     10,836,476      —        —        10,836,476

Auction rate securities rights

     2,706,210      —        —        2,706,210

Investment in affiliated entity

     13,374,976      13,374,976      —        —  
                           

Total Assets

   $ 46,206,179    $ 24,663,493    $ 8,000,000    $ 13,542,686
                           

Liabilities:

           

Common stock warrants

   $ 1,718,492      —        —      $ 1,718,492
                           

Total Liabilities

   $ 1,718,492    $ —      $ —      $ 1,718,492
                           

Level 1 assets include money market funds held by the Company which are valued at quoted market prices, as well as the Company’s investment in VGX International, Inc. (VGX Int’l), for which the fair value is based on the market value of 8,075,775 common shares on March 31, 2010 listed on the Korean Stock Exchange.

 

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INOVIO PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

(Unaudited)

 

Level 2 assets include certificates of deposit held by the Company with maturities that range from 91 days to 12 months. The Company determines fair value through broker quotations with reasonable levels of price transparency. Our certificates of deposit have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, typically utilizing market observable data.

Level 3 assets held as of March 31, 2010 include municipal debt obligations known as auction rate securities (“ARS”). Due to conditions in the global credit markets, these securities, representing a par value of $13.6 million, are currently not liquid. Level 3 liabilities held as of March 31, 2010 consist of common stock warrant liabilities associated with warrants to purchase the Company’s common stock issued in October 2006, August 2007 and July 2009.

In December 2008, the Company, via its wholly-owned subsidiary Genetronics, Inc. (“Genetronics”), which holds the ARS, accepted an offer of ARS Rights from UBS. The ARS Rights permit the Company to require UBS to purchase the Company’s ARS at par value at any time during the period of June 30, 2010 through July 2, 2012. If the Company does not exercise its ARS Rights, the ARS will continue to accrue interest as determined by the terms of the ARS. If the ARS Rights are not exercised before July 2, 2012 they will expire and UBS will have no further obligation to buy the Company’s ARS. UBS has the discretion to purchase or sell the Company’s ARS at any time without prior notice so long as the Company receives a payment at par upon any sale or disposition. UBS will only exercise its discretion to purchase or sell the Company’s ARS for the purpose of restructurings, dispositions or other solutions that will provide the Company with par value for its ARS. As a condition to accepting the offer of ARS Rights, the Company released UBS from all claims except claims for consequential damages relating to its marketing and sales of ARS. The Company also agreed not to serve as a class representative or receive benefits under any class action settlement or investor fund.

While the Company continues to earn interest on its ARS at the maximum contractual rates, these investments are not currently trading and therefore do not currently have a readily determinable market value. Accordingly, the estimated fair value of the ARS no longer approximates par value. The Company has used a discounted cash flow model to determine the estimated fair value of its investment in ARS and its ARS Rights as of March 31, 2010. The assumptions used in preparing the discounted cash flow model include estimates for interest rates, timing and amount of cash flows and expected holding period of the ARS and ARS Rights.

As of March 31, 2010, these ARS investment securities and the ARS and Put option are recorded as current assets due to the time frame in which they can be readily convertible to cash.

The Company elected to measure the ARS Rights at fair value to mitigate volatility in reported earnings due to their linkage to the ARS. The ARS Rights will continue to be measured at fair value utilizing Level 3 inputs until the earlier of their maturity or exercise.

There have been no transfers of assets or liabilities between the fair value measurement classifications.

There were no changes in fair value of the Company’s total Level 3 financial assets for the three months ended March 31, 2010 as shown in the following table:

 

     Auction Rate
Securities
 

Balance at January 1, 2010

   $ 13,542,686   

Change in value of auction rate security

     438,946   

Change in value of auction rate security rights

     (438,946
        

Balance at March 31, 2010

   $ 13,542,686   
        

As of March 31, 2010, the Company has a $1.7 million common stock warrant liability. The Company reassesses the fair value of the common stock warrants at each reporting date utilizing a Black-Scholes pricing model. Inputs used in the pricing model include estimates of stock price volatility, expected warrant life and risk-free interest rate. The Company develops its estimates based on historical data. As a result of these calculations, the Company recorded a net gain of $1.1 million for the three months ended March 31, 2010. The net gain is reflected in the Company’s unaudited condensed consolidated statement of operations as a component of other income, net.

 

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INOVIO PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

(Unaudited)

 

The following table presents the changes in fair value of the Company’s total Level 3 financial liabilities for the three months ended March 31, 2010:

 

     Common Stock
Warrants
 

Balance at January 1, 2010

   $ 2,774,850   

Realized gain included in other income, net

     (1,056,358
        

Balance at March 31, 2010

   $ 1,718,492   
        

6. Line of Credit

On August 26, 2008, the Company received notice from UBS Bank USA (“UBS”) that the Company’s application had been approved for a $5.0 million uncommitted demand revolving line of credit (“Line of Credit”) secured by ARS held by the Company in an account with UBS Financial Services, Inc. (the “Collateral Account”), to provide additional working capital. On December 19, 2008, the Company amended its existing loan agreement with UBS Bank USA, increasing the existing credit line up to $12.1 million, with the ARS pledged as collateral. The Company fully drew down on the line of credit on December 23, 2008. Advances under the Line of Credit bear interest at LIBOR plus 1.00% (the “Spread Over LIBOR”). UBS may change the Spread Over LIBOR at its discretion when the Collateral consisting of ARS may be sold, exchanged or otherwise conveyed by the Company for gross proceeds that are, in the aggregate, not less than the par value of such securities. The loan is treated as a “no net cost loan”, as it bears interest at a rate equal to the average rate of interest paid to the Company on the pledged ARS, and the net interest cost to the Company is zero.

7. Goodwill and Intangible Assets

In accordance with the guidance regarding goodwill and other intangible assets, the Company’s goodwill is not amortized, but is subject to an annual impairment test which is performed by the Company as of November each year or sooner if indicators of impairment exist. The following sets forth the intangible assets by major asset class:

 

     Useful
Life
(Yrs)
   March 31, 2010    December 31, 2009
        Gross    Accumulated
Amortization
    Net Book
Value
   Gross    Accumulated
Amortization
    Net Book
Value

Non-Amortizing:

                  

Goodwill(a)

      $ 10,113,371    $ —        $ 10,113,371    $ 10,113,371    $ —        $ 10,113,371

Amortizing:

                  

Patents

   8 - 17      5,802,528      (3,838,037     1,964,491      5,802,528      (3,727,747     2,074,781

Licenses

   8 - 17      1,198,781      (970,454     228,327      1,198,781      (965,907     232,874

CELLECTRA ® (b)

   5 - 11      8,106,270      (1,007,962     7,098,308      8,106,270      (705,573     7,400,697

GHRH(b)

   11      335,314      (26,403     308,911      335,314      (18,482     316,832

Other(c)

   18      4,050,000      (1,162,500     2,887,500      4,050,000      (1,106,250     2,943,750
                                              

Total intangible assets

        19,492,893      (7,005,356     12,487,537      19,492,893      (6,523,959     12,968,934
                                              

Total goodwill and intangible assets

      $ 29,606,264    $ (7,005,356   $ 22,600,908    $ 29,606,264    $ (6,523,959   $ 23,082,305
                                              

 

(a) Goodwill was recorded from the Inovio AS acquisition in January 2005 and from the acquisition of VGX in June 2009 for $3.9 million and $6.2 million, respectively.
(b)

CELLECTRA ® and GHRH are developed technologies which were recorded from the acquisition of VGX.

(c) Other intangible assets represent the fair value of acquired contracts and intellectual property from the Inovio AS acquisition.

Aggregate amortization expense on intangible assets for the three months ended March 31, 2010 and 2009 was $481,000 and $182,000, respectively. Estimated aggregate amortization expense for each of the five succeeding fiscal years is $1.4 million for the remainder of fiscal year 2010, $1.9 million for 2011, $1.8 million for 2012, $1.8 million for 2013, and $932,000 for 2014.

 

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INOVIO PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

(Unaudited)

 

8. Stockholders’ Equity

The following is a summary of the Company’s authorized and issued common and preferred stock as of March 31, 2010 and December 31, 2009:

 

     Authorized    Issued    Outstanding as of
           March 31,
2010
   December 31,
2009

Common Stock, par $0.001

   300,000,000    102,765,682    102,765,682    102,746,058

Series A Preferred Stock, par $0.001

   1,000    817    —      —  

Series B Preferred Stock, par $0.001

   1,000    750    —      —  

Series C Preferred Stock, par $0.001

   1,091    1,091    26    26

Series D Preferred Stock, par $0.001

   1,966,292    1,966,292    —      —  

Preferred Stock

The following is a summary of changes in the number of outstanding shares of the Company’s Series C preferred stock for the three months ended March 31, 2010 and 2009:

 

     Series C

Shares Outstanding as of January 1, 2010

   26

Preferred Shares converted

   —  
    

Shares Outstanding as of March 31, 2010

   26
    

Shares Outstanding as of January 1, 2009

   71

Preferred Shares converted

   —  
    

Shares Outstanding as of March 31, 2009

   71
    

Common Stock

In July 2009, the Company entered into a securities purchase agreement with certain institutional investors relating to the sale and issuance of (a) 11,111,110 shares of common stock and (b) warrants to purchase a total of 2,777,776 shares of common stock with an exercise price of $3.50 per share, for an aggregate purchase price of approximately $30 million. The warrants were exercisable beginning six months after issuance and expire six months from the date they are first exercisable. The shares of common stock and warrants were sold in units, consisting of one share of common stock and a warrant to purchase 0.25 of a share of common stock, at a purchase price of $2.70 per unit. The Company received net proceeds from the transaction of approximately $28.4 million, after deducting offering expenses. As of March 31, 2010, none of these warrants have been exercised.

Upon the closing of the Merger in June 2009, an aggregate of 41,492,757 shares of the Company’s common stock were issued to the former stockholders of VGX, and an additional 18,794,187 shares of the Company’s common stock were reserved for issuance upon exercise of the assumed options and warrants and conversion of the principal of and maximum interest payable on the VGX convertible debt. In August 2009, the VGX convertible debt was automatically converted into 4,600,681 shares of the Company’s common stock. VGX warrants assumed were ten-year warrants to purchase an aggregate of 4,923,406 shares of the Company’s common stock with an exercise price ranging from $0.26 to $1.28 per share, exercisable at various dates from March 25, 2013 through April 28, 2016. As of March 31, 2010, none of these warrants have been exercised.

In August 2007, the Company entered into an agreement with an outside consulting advisor pursuant to which the Company issued 230,000 registered shares of common stock and registered warrants to purchase 150,000 shares of common stock, as payment of a non-refundable retainer in connection with the engagement of its services. The warrants issued have an exercise price of $3.00 per share, and are exercisable through August 6, 2012. As of March 31, 2010, none of these warrants have been exercised.

In January 2007, the Company exchanged 2,201,644 restricted shares of common stock and warrants to purchase up to 770,573 restricted shares of common stock for 2,201,644 ordinary shares of its Singapore subsidiary Inovio Asia Pte. Ltd. (IAPL), pursuant to

 

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INOVIO PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

(Unaudited)

 

the terms of the Securities Purchase and Exchange Agreement under which the ordinary shares were originally issued by IAPL in October 2006 for $5.3 million. The warrants issued have an exercise price of $2.87 per share and are exercisable through October 13, 2011. As of March 31, 2010, none of these warrants have been exercised.

The Company accounts for registered common stock warrants issued in October 2006, August 2007 and July 2009 under the authoritative guidance on accounting for derivative financial instruments indexed to, and potentially settled in, a company’s own stock, on the understanding that in compliance with applicable securities laws, the registered warrants require the issuance of registered securities upon exercise and do not sufficiently preclude an implied right to net cash settlement. The Company classifies registered warrants on the consolidated balance sheet as a current liability which is revalued at each balance sheet date subsequent to the initial issuance. Determining the appropriate fair-value model and calculating the fair value of registered warrants requires considerable judgment, including estimating stock price volatility and expected warrant life. The Company develops its estimates based on historical data. A small change in the estimates used may have a relatively large change in the estimated valuation. The Company uses the Black-Scholes pricing model to value the registered warrants. Changes in the fair market value of the warrants are reflected in the condensed consolidated statement of operations as “Other income, net.”

Warrants

In addition to warrants granted as discussed above, the Company has issued the following additional warrants.

Participants in our October 2006 registered offering with foreign investors received five-year warrants to purchase an aggregate of 1,593,821 shares of our common stock with an exercise price of $2.87 per share, exercisable through October 13, 2011. As of March 31, 2010, none of these warrants have been exercised.

Participants in our December 2005 private placement were issued five-year warrants to purchase an aggregate of 3,462,451 shares of our common stock with an exercise price of $2.93 per share, exercisable through December 30, 2010. As of March 31, 2010, none of these warrants have been exercised.

On September 15, 2000, the Company entered into an exclusive license agreement with the University of South Florida Research Foundation, Inc. (USF), whereby USF granted us an exclusive, worldwide license to USF’s rights in patents and patent applications generally related to needle electrodes (“License Agreement”). Pursuant to the License Agreement, the Company granted USF and its designees warrants to acquire 150,000 common shares for $9.00 per share until September 14, 2010. Of the total warrants granted, 75,000 vested at the date of grant and the remainder will vest upon the achievement of certain milestones. The remaining 75,000 warrants are forfeitable and will be valued at the fair value on the date of vesting using the Black-Scholes pricing model. As of March 31, 2010, no warrants issued in connection with this licensing agreement had been exercised.

Stock Options

The Company has one active stock and cash-based incentive plan, the Amended and Restated 2007 Omnibus Incentive Plan (the “Incentive Plan”), pursuant to which the Company has granted stock options and restricted stock awards to executive officers, directors and employees. The plan was adopted on March 31, 2007, approved by the stockholders on May 4, 2007, approved by the stockholders as amended on May 2, 2008, and approved by the stockholders as amended and restated on August 25, 2009. The Incentive Plan reserves 3,750,000 shares of common stock for issuance as or upon exercise of incentive awards granted and to be granted at future dates. At March 31, 2010, the Company had 147,626 shares of common stock available for future grant under the plan, and 240,000 shares of vested restricted stock and options to purchase 3,192,161 shares of common stock outstanding under the plan. The awards granted and available for future grant under the Incentive Plan generally have a term of ten years and generally vest over a period of three years. The Incentive Plan terminates by its terms on March 31, 2017.

The Incentive Plan supersedes all of the Company’s previous stock option plans, which includes the Amended 2000 Stock Option Plan, under which the Company had options to purchase 2,313,120 shares of common stock outstanding at March 31, 2010. The terms and conditions of the options outstanding under these plans remain unchanged.

9. Net loss per share

Basic loss per share is computed by dividing the net loss for the year by the weighted average number of common shares outstanding during the year. Diluted loss per share is calculated in accordance with the treasury stock method and reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted to common stock. Since the effect of the assumed exercise of common stock options and warrants was anti-dilutive for all periods presented in 2010 and 2009, there is no difference between basic and diluted loss per share.

 

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INOVIO PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

(Unaudited)

 

10. Stock-Based Compensation

The Company estimates the fair value of stock options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility and expected option life. The Company amortizes the fair value of the awards expected to vest on a straight-line basis. All option grants are amortized over the requisite service period of the awards. Expected volatility is based on historical volatility. The expected life of options granted is based on historical expected life. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant. The forfeiture rate is based on historical data and the Company records stock-based compensation expense only for those awards that are expected to vest. The dividend yield is based on the fact that no dividends have been paid historically and none are currently expected to be paid.

The assumptions used to estimate the fair value of stock options granted for the three month periods ended March 31, 2010 and 2009 are presented below:

 

     Three Months Ended March 31,  
     2010     2009  

Risk-free interest rate

   2.34%-2.64   1.37

Expected volatility

   134   96

Expected life in years

   4      4   

Dividend yield

   —        —     

Total compensation cost for the Company’s stock plans that has been recognized in the condensed consolidated statement of operations for the three months ended March 31, 2010 and 2009 was $293,000 and $155,000, respectively, of which $105,000 and $32,000 was included in research and development expenses and $188,000 and $123,000 was included in general and administrative expenses, respectively.

As of March 31, 2010, there was $1.4 million of total unrecognized compensation cost related to non-vested stock-based compensation arrangements for Inovio stock options, which is expected to be recognized over a weighted-average period of 2.5 years, as well as $80,000 of total unrecognized compensation cost related to non-vested stock-based compensation arrangements from VGX stock options assumed in the Merger, which is expected to be recognized over a weighted-average period of 8 months. All compensation expense related to Inovio stock options granted prior to the Merger was fully vested upon the Merger.

As of March 31, 2009, there was $580,000 of total unrecognized compensation cost related to non-vested stock-based compensation arrangements for Inovio stock options, which was expected to be recognized over a weighted-average period of nine months.

The weighted average grant date fair value per share was $0.92 and $0.34 for employee stock options granted during the three months ended March 31, 2010 and 2009, respectively, excluding VGX stock options assumed pursuant to the merger.

There was no restricted stock granted during the three months ended March 31, 2010 or 2009.

At March 31, 2010, there was no unrecognized compensation cost related to non-vested restricted stock as all restricted stock became vested upon the Merger. At March 31, 2009, there was $141,000 of total unrecognized compensation cost related to non-vested restricted stock, which was expected to be recognized over a weighted-average period of one year.

The fair value of options granted to non-employees at the measurement dates were estimated using the Black-Scholes pricing model. Total stock-based compensation for options granted to non-employees for the three months ended March 31, 2010 and 2009 was $137,000 and $5,000, respectively.

VGX AH, a majority owned subsidiary of VGX, has adopted a 2007 equity incentive plan for the issuance of options to employees and consultants. There were no options granted under this plan during the three months ended March 31, 2010 or 2009.

 

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INOVIO PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

(Unaudited)

 

11. Comprehensive Loss

Comprehensive loss for the three months ended March 31, 2010 and March 31, 2009 includes net loss and foreign currency translation adjustments. A summary of the Company’s comprehensive loss is as follows:

 

     Three Months Ended
March  31,
 
     2010     2009  

Comprehensive loss:

    

Net loss

   $ (2,300,636   $ (3,464,495

Foreign currency translation adjustments

     4,860        16,026   
                

Comprehensive loss

   $ (2,295,776   $ (3,448,469
                

12. Supplemental Disclosures of Cash Flow Information

 

     Three Months Ended
March 31,
     2010    2009

Supplemental schedule of financing activities:

     

Interest paid

   $ 34,368    $ 39,745

13. Related-Party Transactions

The Company conducts transactions with its affiliated entity, VGX Int’l.

For the three months ended March 31, 2010, the Company recognized revenue from VGX Int’l of $7,000 which consisted of licensing fees. Operating expenses related to VGX Int’l for the three months ended March 31, 2010 include $132,000 related to manufacturing and engineering services as well as $1,000 for regulatory and technical support and other consulting services received. At March 31, 2010 the Company had an accounts receivable balance of $3.1 million from VGX Int’l and its subsidiaries.

For the three months ended March 31, 2010, the Company received sublease income from VGX Int’l of $55,000 for the facility in The Woodlands, TX, which offset the Company’s lease expense.

On March 24, 2010, the Company entered into a Collaboration and License Agreement (the “Agreement”) with VGX Int’l. Under the Agreement, the Company granted VGX Int’l an exclusive license to Inovio’s SynCon TM universal influenza vaccine delivered with electroporation to be developed in certain countries in Asia (the “Product”). As consideration for the license granted to VGX Int’l, the Company will receive a payment of $3.0 million as a research and development initiation fee which is reflected in the Company’s accounts receivable from affiliated entity at March 31, 2010, as well as research support, annual license maintenance fees and royalties on net product sales. In addition, contingent upon achievement of clinical and regulatory milestones, the Company will receive development payments over the term of the Agreement. The Agreement also provides Inovio with exclusive rights to supply devices for clinical and commercial purposes (including single use components) to VGX Int’l for use in the Product. The term of the Agreement commenced upon execution and will extend on a country by country basis until the last to expire of all Royalty Periods for the territory (as such term is defined in the Agreement) for any Product in that country, unless the Agreement is terminated earlier in accordance with its provisions as a result of breach, by mutual agreement, or by VGX Int’l right to terminate without cause upon prior written notice.

Dr. J. Joseph Kim, the Company’s CEO, Young Park, the Company’s corporate secretary and Bryan Kim, the Company’s vice president of Asian operations, currently constitute three of the four members of VGX Int’l’s board of directors and receive customary compensation from VGX Int’l for their service in such capacity. Dr. Kim also served as chief executive officer of VGX Int’l prior to our acquisition of VGX Pharmaceuticals, Inc. in June 2009. Bryan Kim currently serves as the president and chief executive officer of VGX Int’l.

 

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

This report contains forward-looking statements. These statements relate to future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of such terms or other comparable terminology. These statements are only predictions. Actual events or results may differ materially.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Moreover, neither we, nor any other person, assume responsibility for the accuracy and completeness of the forward-looking statements. We are under no obligation to update any of the forward-looking statements after the filing of this Quarterly Report to conform such statements to actual results or to changes in our expectations.

The following discussion of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and the related notes and other financial information appearing elsewhere in this Quarterly Report. Readers are also urged to carefully review and consider the various disclosures made by us which attempt to advise interested parties of the factors which affect our business, including without limitation the disclosures made in Item 1A of Part II of this Quarterly Report under the Caption “Risk Factors” and under the captions “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and “Risk Factors” and in our audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2009.

Risk factors that could cause actual results to differ from those contained in the forward-looking statements include but are not limited to: our history of losses; our lack of products that have received regulatory approval; uncertainties inherent in clinical trials and product development programs, including but not limited to the fact that pre-clinical and clinical results may not be indicative of results achievable in other trials or for other indications, that results from one study may not necessarily be reflected or supported by the results of other similar studies, that results from an animal study may not be indicative of results achievable in human studies, that clinical testing is expensive and can take many years to complete, that the outcome of any clinical trial is uncertain and failure can occur at any time during the clinical trial process, and that our electroporation technology and DNA vaccines may fail to show the desired safety and efficacy traits in clinical trials; the availability of funding; the ability to manufacture vaccine candidates; the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that we and our collaborators hope to develop; whether our proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity; and the impact of government healthcare proposals.

General

Inovio Pharmaceuticals, Inc. (the “Company” or “Inovio”) is engaged in the discovery, development, and delivery of a new generation of vaccines, called DNA vaccines, focused on cancers and infectious diseases. Our SynCon™ technology enables the design of “universal” DNA-based vaccines capable of providing cross-protection against new, unmatched strains of pathogens such as influenza. Our electroporation DNA delivery technology uses brief, controlled electrical pulses to increase cellular DNA vaccine uptake. Initial human data has shown this method can safely and significantly increase gene expression and immune responses. Our clinical programs include human papillomavirus (“HPV”)/cervical cancer (therapeutic), avian influenza (preventative), hepatitis C virus (“HCV”) and human immunodeficiency virus (“HIV”) vaccines. We are advancing preclinical research for a universal seasonal/pandemic influenza vaccine. Our partners and collaborators include University of Pennsylvania, National Microbiology Laboratory of the Public Health Agency of Canada, NIAID (NIH), Merck, ChronTech, University of Southampton, and HIV Vaccines Trial Network (“HVTN”).

On June 1, 2009, we completed our acquisition of VGX Pharmaceuticals, Inc. (“VGX”) whereby VGX became a wholly-owned subsidiary of Inovio (the “Merger”). We believe the Merger advances our ability to play a leadership role in the discovery, development, and delivery of DNA vaccines.

On May 14, 2010, we amended our Certificate of Incorporation to change our name from “Inovio Biomedical Corporation” to Inovio Pharmaceuticals, Inc.

 

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Recent Developments

On March 24, 2010, we entered into a Collaboration and License Agreement (the “Agreement”) with VGX International (“VGX Int’l”). Under the Agreement, we granted VGX Int’l an exclusive license to Inovio’s SynCon TM universal influenza vaccine delivered with electroporation to be developed in certain countries in Asia (the “Product”).

As consideration for the license granted to VGX Int’l, we will receive a payment of $3.0 million as a research and development initiation fee, as well as research support, annual license maintenance fees and royalties on net product sales. In addition, contingent upon achievement of clinical and regulatory milestones, we will receive development payments over the term of the Agreement. The Agreement also provides Inovio with exclusive rights to supply devices for clinical and commercial purposes (including single use components) to VGX Int’l for use in the Product.

The term of the Agreement commenced upon execution and will extend on a country by country basis until the last to expire of all Royalty Periods for the territory (as such term is defined in the Agreement) for any Product in that country, unless the Agreement is terminated earlier in accordance with its provisions as a result of breach, by mutual agreement, or by VGX Int’l right to terminate without cause upon prior written notice.

In January 2010, we announced that we expanded our existing license agreement with the University of Pennsylvania, adding exclusive worldwide licenses for technology and intellectual property for novel DNA vaccines against pandemic influenza, Chikungunya, and foot-and-mouth disease. The amendment also encompasses new chemokine and cytokine molecular adjuvant technologies. The technology was developed in the University of Pennsylvania laboratory of Professor David B. Weiner, a pioneer in the field of DNA vaccines, and chairman of our scientific advisory board. Under the terms of the original license agreement completed in 2007, we obtained exclusive worldwide rights to develop multiple DNA plasmids and constructs with the potential to treat and/or prevent HIV, HCV, HPV and influenza and included molecular adjuvants. These prior and most recent agreements and amendments provide for royalty payments, based on future sales, to the University of Pennsylvania.

As of March 31, 2010, we had an accumulated deficit of $179.5 million. We expect to continue to incur substantial operating losses in the future due to our commitment to our research and development programs, the funding of preclinical studies, clinical trials and regulatory activities and the costs of general and administrative activities.

Critical Accounting Policies

The SEC defines critical accounting policies as those that are, in management’s view, important to the portrayal of our financial condition and results of operations and require management’s judgment. Our discussion and analysis of our financial condition and results of operations is based on our audited consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses. We base our estimates on experience and on various assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates. Our critical accounting policies include:

Revenue Recognition. License fees are comprised of initial fees and milestone revenue derived from collaborative licensing arrangements. We continue to recognize non-refundable milestone payments upon the achievement of specified milestones upon which we have earned the milestone payment, provided the milestone payment is substantive in nature and the achievement of the milestone was not reasonably assured at the inception of the agreement. We defer payments for milestone events which are reasonably assured and recognize them ratably over the minimum remaining period of our performance obligations. Payments for milestones which are not reasonably assured are treated as the culmination of a separate earnings process and are recognized as revenue when the milestones are achieved.

We have adopted a strategy of co-developing or licensing our gene delivery technology for specific genes or specific medical indications. Accordingly, we have entered into collaborative research and development agreements and have received funding for pre-clinical research and clinical trials. Payments under these agreements, which are non-refundable, are recorded as revenue as the related research expenditures are incurred pursuant to the terms of the agreements and provided collectability is reasonably assured.

We receive non-refundable grants under available government programs. Government grants towards current expenditures are recorded as revenue when there is reasonable assurance that we have complied with all conditions necessary to receive the grants, collectability is reasonably assured, and as the expenditures are incurred.

 

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Research and development expenses. Since our inception, virtually all of our activities have consisted of research and development efforts related to developing our electroporation technologies and DNA vaccines. Research and development expenses consist of expenses incurred in performing research and development activities including salaries and benefits, facilities and other overhead expenses, clinical trials, contract services and other outside expenses. Research and development expenses are charged to operations as they are incurred.

Valuation and Impairment Evaluations of Goodwill and Intangible Assets. Goodwill represents the excess of acquisition cost over the fair value of the net assets of acquired businesses. Intangible assets are amortized over their estimated useful lives ranging from 5 to 18 years. Acquired intangible assets are still being developed for the future economic viability contemplated at the time of acquisition. We are concurrently conducting Phase I and pre-clinical trials using the acquired intangibles, and we have entered into certain significant licensing agreements for use of these acquired intangibles.

Historically we have recorded patents at cost and amortized these costs using the straight-line method over the expected useful lives of the patents or 17 years, whichever is less. Patent cost consists of the consideration paid for patents and related legal costs. Effective June 1, 2009, in connection with our acquisition of VGX Pharmaceuticals, all new patent costs will be expensed as incurred. Patent cost currently capitalized will continue to be amortized over the expected life of the patent. The effect of this change was immaterial to prior periods. License costs are recorded based on the fair value of consideration paid and amortized using the straight-line method over the shorter of the expected useful life of the underlying patents or the term of the related license agreement. As of March 31, 2010, our intangible assets resulting from the acquisition of VGX and Inovio AS, and additional intangibles including previously capitalized patent costs and license costs, net of accumulated amortization, totaled $12.5 million.

The determination of the value of such intangible assets requires management to make estimates and assumptions that affect our consolidated financial statements. We assess potential impairments to intangible assets when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. Our judgments regarding the existence of impairment indicators and future cash flows related to intangible assets are based on operational performance of our acquired businesses, market conditions and other factors. If impairment is indicated, we reduce the carrying value of the intangible asset to fair value. While our current and historical operating and cash flow losses are potential indicators of impairment, we believe the future cash flows to be received from our intangible assets will exceed the intangible assets’ carrying value, and accordingly, we have not recognized any impairment losses through March 31, 2010.

Although there are inherent uncertainties in this assessment process, the estimates and assumptions we use are consistent with our internal planning. If these estimates or their related assumptions change in the future, we may be required to record an impairment charge on all or a portion of our goodwill and intangible assets. Furthermore, we cannot predict the occurrence of future impairment-triggering events nor the impact such events might have on our reported asset values. Future events could cause us to conclude that impairment indicators exist and that goodwill or other intangible assets associated with our acquired businesses are impaired. Any resulting impairment loss could have an adverse impact on our results of operations.

Purchase Price Allocation. The purchase price allocation for acquisitions requires extensive use of accounting estimates and judgments to allocate the purchase price to the identifiable tangible and intangible assets acquired, including in-process research and development, and liabilities assumed based on their respective fair values. Additionally, we must determine whether an acquired entity is considered to be a business or a set of net assets, because a portion of the purchase price can only be allocated to goodwill in a business combination.

Stock-based Compensation. Stock-based compensation cost is estimated at the grant date based on the fair-value of the award and is recognized as an expense ratably over the requisite service period of the award. Determining the appropriate fair-value model and calculating the fair value of stock-based awards at the grant date requires considerable judgment, including estimating stock price volatility, expected option life and forfeiture rates. We develop our estimates based on historical data. If factors change and we employ different assumptions in future periods, the compensation expense that we record may differ significantly from what we have recorded in the current period. A small change in the estimates used may have a relatively large change in the estimated valuation. We use the Black-Scholes pricing model to value stock option awards. We recognize compensation expense using the straight-line amortization method.

Auction Rate Securities and Auction Rate Securities Rights. We account for Auction Rate Securities (“ARS”) under the authoritative guidance for certain investments in debt and equity securities and fair value measurements. We account for ARS Rights using the fair value option for financial assets and financial liabilities. Our investments in ARS and our ARS Rights are recorded at their estimated fair value as there is currently no liquid market which indicates value. We have used a discounted cash flow model to determine the estimated fair value of our investment in ARS and our ARS Rights as of March 31, 2010. The assumptions used in preparing the discounted cash flow model include estimates for interest rates, timing and amount of cash flows and expected holding period of the ARS and ARS Rights. Changes in the estimated fair value of the ARS and ARS Rights are reflected in the condensed consolidated statement of operations as “Other income, net.”

 

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Registered Common Stock Warrants. We account for registered common stock warrants pursuant to the authoritative guidance on accounting for derivative financial instruments indexed to, and potentially settled in, a company’s own stock, on the understanding that in compliance with applicable securities laws, the registered warrants require the issuance of registered securities upon exercise and do not sufficiently preclude an implied right to net cash settlement. We classify registered warrants on the consolidated balance sheet as a current liability which is revalued at each balance sheet date subsequent to the initial issuance. Determining the appropriate fair-value model and calculating the fair value of registered warrants requires considerable judgment, including estimating stock price volatility and expected warrant life. We develop our estimates based on historical data. A small change in the estimates used may have a relatively large change in the estimated valuation. We use the Black-Scholes pricing model to value the registered warrants. Changes in the fair market value of the warrants are reflected in the condensed consolidated statement of operations as “Other income, net.”

Pending Adoption of Recent Accounting Pronouncements

We describe below recent pronouncements that may have a significant effect on our financial statements. We do not discuss recent pronouncements that are not anticipated to have an impact on or are unrelated to our financial condition, results of operations, or related disclosures.

Accounting Standards Update 2009-13 —In September 2009, the Financial Accounting Standards Board (“FASB”) ratified the final consensus reached by the Emerging Issues Task Force (“EITF”) that revised the authoritative guidance for revenue arrangements with multiple deliverables. The guidance addresses how to determine whether an arrangement involving multiple deliverables contains more than one unit of accounting and how the arrangement consideration should be allocated among the separate units of accounting. The guidance will be effective for our fiscal year beginning January 1, 2011 with early adoption permitted. The guidance may be applied retrospectively or prospectively for new or materially modified agreements. We are currently evaluating early prospective adoption and determining the effects, if any, the adoption of the guidance will have on our condensed consolidated financial statements.

Accounting Standards Update 2010-3 —In March 2010, the FASB ratified the final consensus that offers an alternative method of revenue recognition for milestone payments. The guidance states that an entity can make an accounting policy election to recognize a payment that is contingent upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. The guidance will be effective for fiscal years, and interim periods within those years, beginning on or after June 15, 2010 with early adoption permitted, provided that the revised guidance is applied retrospectively to the beginning of the year of adoption. The guidance may be applied retrospectively or prospectively for milestones achieved after the adoption date. We are currently evaluating early prospective adoption and determining the effects, if any, the adoption of this guidance will have on our condensed consolidated financial statements.

Results of Operations

Revenue. We had total revenue of $1.4 million and $369,000 for the three months ended March 31, 2010 and 2009, respectively. Revenue primarily consists of license fees, milestone revenue and amounts received from collaborative research and development agreements, grants and government contracts.

Revenue from license fees and milestone revenue was $74,000 and $213,000 for the three months ended March 31, 2010 and 2009, respectively. The decrease in revenue under license fees and milestone revenue for the three month period ended March 31, 2010, as compared to the comparable period in 2009, was mainly due to no revenues recognized under the Wyeth collaboration and licensing agreement as a result of the cancellation of the agreement in July 2009, as well as no royalties recognized from various smaller license agreements.

During the three months ended March 31, 2010, we recorded no revenue under collaborative research and development arrangements as compared to $54,000 for the three months ended March 31, 2009. This decrease in revenue was primarily due to no revenues recognized under our research and collaboration agreement with Merck, as we have provided the majority of the required device development for use in their clinical trials. We believe that development activities will be limited until trial results are obtained.

During the three months ended March 31, 2010 and 2009, we recorded grant and miscellaneous revenue of $1.3 million and $102,000, respectively. The increase in grant and miscellaneous revenue for the three months ended March 31, 2010, as compared to the comparable period in 2009, was primarily due to revenues recognized from our contract with the National Institute of Allergy and

 

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Infectious Diseases (“NIAID”) and the PATH Malaria Vaccine Initiative (“MVI”) of $835,000 and $239,000, respectively, and from the Department of Defense (“U.S. Army”) grant of $200,000 for the three months ended March 31, 2010. The NIAID contract is for five years with two one-year options (period of performance is September 30, 2008 — September 29, 2015 including the two options). The value for the five years is $21.3 million with option years six and seven valued at $1.2 million and $1.1 million, respectively, for a total potential value of $23.6 million, and will fund research and development for HIV DNA-based vaccines delivered via our proprietary electroporation system. PATH is an international nonprofit organization funded by private donors. We have a research program and agreement with the PATH MVI to evaluate in a preclinical feasibility study our SynCon™ DNA vaccine development platform to target antigens from Plasmodium species and deliver them intradermally using the CELLECTRA ® electroporation device. The agreement with MVI was for $685,000 and was completed in February 2010. The U.S. Army grant has a total value of $933,000, will fund research and development of DNA-based vaccines delivered via our proprietary electroporation system and will run through May 2010. This project is focused on identifying DNA vaccine candidates with the potential to provide rapid, robust immunity to protect against bio-warfare and bioterror attacks.

Research and Development Expenses. Research and development expenses for the three months ended March 31, 2010 and 2009, were $2.7 million and $964,000, respectively. The increase in research and development expenses for the three months ended March 31, 2010, as compared to the comparable period in 2009, was primarily due to higher costs related to work performed for the NIAID and MVI contracts, higher other outside services and contract labor expenses related to research and development projects, higher outside engineering professional services related to CELLECTRA ® development, higher clinical trial costs and higher personnel costs due to greater employee headcount on average throughout the quarter. The increase was partially offset by a decrease in research and development expenses incurred by Inovio AS and Inovio Tec as these entities ceased operations in late 2009.

General and Administrative Expenses. General and administrative expenses, which include business development expenses and the amortization of intangible assets, for the three months ended March 31, 2010 and 2009, were $3.1 million and $3.0 million, respectively. The increase in general and administrative expenses for the three months ended March 31, 2010, as compared to the comparable period in 2009, was primarily due to higher amortization expense as a result of the intangible assets that were acquired from VGX, higher personnel costs due to greater employee headcount on average throughout the quarter and higher consultant stock option expense as a result of the stock options that were acquired from VGX. The increase was partially offset by a decrease in legal and related fees associated with the Merger and other corporate matters.

Stock-based Compensation. Stock-based compensation cost is measured at the grant date, based on the fair value of the award reduced by estimated forfeitures, and is recognized as expense over the employee’s requisite service period. Total compensation cost for our stock plans for the three months ended March 31, 2010 and 2009 was $293,000 and $155,000, respectively. From these amounts, $105,000 and $32,000 was included in research and development expenses and $188,000 and $123,000 was included in general and administrative expenses, respectively. The increase in stock-based compensation cost for the three months ended March 31, 2010, as compared to the comparable period in 2009, was primarily due to an increase in total options granted during the quarter as well as the continued vesting of options granted to employees in 2009 after the merger.

Interest Income, net. Interest income, net, for the three months ended March 31, 2010 and 2009 was $35,000 and $34,000 respectively. The slight increase in interest income, net, for the first three months of 2010, as compared to 2009, was primarily due to a higher cash and investments balance.

Other Income, net. We recorded other income, net, for the three months ended March 31, 2010 and 2009 of $1.0 million and $62,000 respectively. The increase in other income, net, is primarily due to the revaluation of registered common stock warrants issued by us in October 2006, August 2007 and July 2009. We are required to revalue the warrants at each balance sheet date to fair value. If unexercised, the warrants will expire at various dates between August 2010 and July 2014.

Gain (Loss) from investment in affiliated entity. Gain (loss) is a result of the change in the fair market value of the investment as of March 31, 2010 .

Liquidity and Capital Resources

Historically, our primary uses of cash have been to finance research and development activities including clinical trial activities in the oncology, DNA vaccines and other immunotherapy areas of our business. Since inception, we have satisfied our cash requirements principally from proceeds from the sale of equity securities.

 

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Working Capital and Liquidity

As of March 31, 2010, we had working capital of $25.4 million, as compared to $25.2 million as of December 31, 2009. The increase in working capital during the three months ended March 31, 2010 was primarily due to the significant receivable balance of $3.0 million due from VGX Int’l in connection with the March 2010 Collaboration and License Agreement, as well as a decrease in the valuation of registered common stock warrants and decrease in the accounts payable and accrued expenses balance. These increases were offset by expenditures related to our research and development activities, as well as various general and administrative expenses related to legal, consultants, accounting and audit, and corporate development. Based on management’s projections and analysis, we believe that our cash and cash equivalents are sufficient to meet our planned working capital requirements through the second half of 2011.

Net cash used in operating activities was $4.5 million and $2.3 million for the three months ended March 31, 2010 and 2009, respectively. The increase in net cash used in operating activities for the three months ended March 31, 2010, compared with the prior year period, was primarily the result of increased spending by our post-Merger Company on clinical, engineering and other research and development activities to support our programs.

Our ARS are municipal debt obligations with an underlying long-term maturity. Due to conditions in the global credit markets these securities, representing a par value of $13.6 million, are currently not liquid.

In December 2008, we, via our wholly-owned subsidiary Genetronics, which holds the ARS, accepted an offer of ARS Rights from UBS. The ARS Rights permit us to require UBS to purchase our ARS at par value at any time during the period of June 30, 2010 through July 2, 2012. If we do not exercise our ARS Rights, the ARS will continue to accrue interest as determined by the terms of the ARS. If the ARS Rights are not exercised before July 2, 2012 they will expire and UBS will have no further obligation to buy our ARS. UBS has the discretion to purchase or sell our ARS at any time without prior notice so long as we receive a payment at par upon any sale or disposition. UBS will only exercise its discretion to purchase or sell our ARS for the purpose of restructurings, dispositions or other solutions that will provide us with par value for our ARS. As a condition to accepting the offer of ARS Rights, we released UBS from all claims except claims for consequential damages relating to its marketing and sales of ARS. We also agreed not to serve as a class representative or receive benefits under any class action settlement or investor fund.

In conjunction with the acceptance of the ARS Rights, we also amended our existing loan agreement with UBS Bank USA, increasing the existing credit line up to $12.1 million, with the ARS pledged as collateral. The loan is treated as a “no net cost loan”, as it bears interest at a rate equal to the average rate of interest paid to Genetronics on the pledged ARS, and the net interest cost to Genetronics is zero. We fully drew down on the line of credit in December 2008.

Historically, the fair value of ARS approximated par value. While we continue to earn interest on our ARS at the maximum contractual rates, these investments are not currently trading and therefore do not currently have a readily determinable market value. Accordingly, the estimated fair value of the ARS no longer approximates par value. We have used a discounted cash flow model to determine the estimated fair value of our investment in ARS and our ARS Rights as of March 31, 2010. The assumptions used in preparing the discounted cash flow model include estimates for interest rates, timing and amount of cash flows and expected holding period of the ARS and ARS Rights.

As of March 31, 2010, we had an accumulated deficit of $179.5 million. We have operated at a loss since 1994, and we expect this to continue for some time. The amount of the accumulated deficit will continue to increase, as it will be expensive to continue research and development efforts. If these activities are successful and if we receive approval from the FDA to market DNA vaccines and equipment, then even more funding will be required to market and sell the approved vaccine products and equipment. The outcome of the above matters cannot be predicted at this time. We are evaluating potential collaborations as an additional way to fund operations. We will continue to rely on outside sources of financing to meet our capital needs beyond mid-2011. We have on file an effective shelf registration statement that allows us to raise up to an additional $45.0 million from the sale of common stock, preferred stock, debt securities and/or warrants.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Interest Rate Risk

Market risk represents the risk of loss that may impact our consolidated financial position, results of operations or cash flows due to adverse changes in financial and commodity market prices and rates. We are exposed to market risk primarily in the area of changes in U.S. interest rates and conditions in the credit markets, and the recent fluctuations in interest rates and availability of funding in the credit markets primarily impacts the performance of our investments. We do not have any material foreign currency or other derivative financial instruments. Under our current policies, we do not use interest rate derivative instruments to manage

 

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exposure to interest rate changes. We attempt to increase the safety and preservation of our invested principal funds by limiting default risk, market risk and reinvestment risk. We mitigate default risk by investing in investment grade securities.

Fair Value measurements

All of our investment securities are classified as trading securities and are reported on the consolidated balance sheet at market value. Our investment securities consist of auction rate securities (“ARS”) issued primarily by municipalities, with a par value of approximately $13.6 million. As a result of the negative conditions in the global credit markets, our ARS are currently not liquid, and if we do not exercise our ARS Rights (discussed in the following paragraph) we could be required to hold them until they are redeemed by the issuer or to maturity. In the event we need to access the funds that are in an illiquid state, we will not be able to do so without a loss of principal, until the securities are redeemed by the issuer or they mature.

In December 2008, we, via our wholly-owned subsidiary Genetronics, which holds the ARS, accepted an offer of ARS Rights from our investment advisor, UBS Financial Services, Inc., a subsidiary of UBS AG, or UBS. The ARS Rights permit us to require UBS to purchase our ARS at par value at any time during the period of June 30, 2010 through July 2, 2012. If we do not exercise our ARS Rights, the ARS will continue to accrue interest as determined by the terms of the ARS. If the ARS Rights are not exercised before July 2, 2012 they will expire and UBS will have no further obligation to buy our ARS. UBS has the discretion to purchase or sell our ARS at any time without prior notice so long as we receive a payment at par upon any sale or disposition. UBS will only exercise its discretion to purchase or sell our ARS for the purpose of restructurings, dispositions or other solutions that will provide us with par value for our ARS. As a condition to accepting the offer of ARS Rights, we released UBS from all claims except claims for consequential damages relating to its marketing and sales of ARS. We also agreed not to serve as a class representative or receive benefits under any class action settlement or investor fund.

In conjunction with the acceptance of the ARS Rights, we also amended our existing loan agreement with UBS Bank USA, increasing the existing credit line up to $12.1 million, with the ARS pledged as collateral. The loan is treated as a “no net cost loan”, as it bears interest at a rate equal to the average rate of interest paid to us on the pledged ARS, and our net interest cost will be zero. We fully drew down on the line of credit in December 2008.

Foreign Currency Risk

We have operated primarily in the U.S. and most transactions during the year ended December 31, 2009, have been made in U.S. dollars. Accordingly, we have not had any material exposure to foreign currency rate fluctuations, with the exception of the valuation of our equity investment in VGX Int’l. We do not have any foreign currency hedging instruments in place.

We have conducted clinical trials in Europe in conjunction with several Clinical Research Organizations (“CRO’s”), where we have clinical sites being monitored by Clinical Research Associates (“CRA’s”). While invoices relating to these clinical trials are generally denominated in U.S. dollars, our financial results could be affected by factors such as inflation in foreign currencies, in relation to the U.S. dollar, in markets where these vendors have assisted us in conducting these clinical trials.

Certain transactions related to our Company and our subsidiary Inovio Asia Pte. Ltd. (“IAPL”), are denominated primarily in foreign currencies, including Euros, British Pounds, Canadian Dollars, and Singapore Dollars. Our equity investment in VGX Int’l is denominated in South Korean Won. As a result, our financial results could be affected by factors such as changes in foreign currency exchange rates or weak economic conditions in foreign markets where Inovio conducts business, including the impact of the existing crisis in the global financial markets in such countries and the impact on both the U.S. dollar and the noted foreign currencies.

We do not use derivative financial instruments for speculative purposes. We do not engage in exchange rate hedging or hold or issue foreign exchange contracts for trading purposes. Currently, we do not expect the impact of fluctuations in the relative fair value of other currencies to be material in 2010.

 

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures, which are designed to ensure that information required to be disclosed in the

 

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reports we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer, or CEO, and Chief Financial Officer, or CFO, as appropriate to allow timely decisions regarding required disclosures.

Based on an evaluation carried out as of the end of the period covered by this quarterly report, under the supervision and with the participation of our management, including our CEO and CFO, our CEO and CFO have concluded that, as of the end of such period, our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) were effective as of March 31, 2010.

Changes in Internal Control Over Financial Reporting

There have not been any changes in our internal control over financial reporting (as defined in Rules 13a—15(f) and 15d—15(f) under the Securities Exchange Act of 1934) that occurred during the three months ended March 31, 2010, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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Part II. Other Information

 

Item 1. Legal Proceedings

Not applicable.

 

Item 1A. Risk Factors

You should carefully consider and evaluate each of the following factors as well as the other information in this quarterly report on Form 10-Q, including our financial statements and the related notes, in evaluating our business and prospects. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently consider immaterial may also impair our business operations. If any of the following risks actually occur, our business and financial results could be harmed. In that case, the trading price of our common stock could decline. You should also consider the more detailed description of our business contained in our annual report on Form 10-K for the year ended December 31, 2009, which we filed with the Securities and Exchange Commission on March 26, 2010

Risks Related to Our Business and Industry

We have incurred losses since inception, expect to incur significant net losses in the foreseeable future and may never become profitable.

We have experienced significant operating losses to date; as of March 31, 2010 our accumulated deficit was approximately $179.5 million. We have generated limited revenues, primarily consisting of license and grant revenue, and interest income. We expect to continue to incur substantial additional operating losses for at least the next several years as we advance our clinical trials and research and development activities. We may never successfully commercialize our vaccine product candidates or electroporation-based DNA vaccine delivery technology and thus may never have any significant future revenues or achieve and sustain profitability.

We have limited sources of revenue and our success is dependent on our ability to develop our vaccine and other product candidates and electroporation equipment.

Other than a DNA therapy for food animals, whose sales have not been significant, we do not sell any products and may not have any other products commercially available for several years, if at all. Our ability to generate future revenues depends heavily on our success in:

 

   

developing and securing U.S. and/or foreign regulatory approvals for our product candidates, including securing regulatory approval for conducting clinical trials with product candidates;

 

   

developing our electroporation-based DNA delivery technology;

 

   

commercializing any products for which we receive approval from the FDA and foreign regulatory authorities; and

 

   

developing a market for LifeTide™ and/or our other animal health product candidates.

 

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Our electroporation equipment and product candidates will require extensive additional clinical study and evaluation, regulatory approval in multiple jurisdictions, substantial investment and significant marketing efforts before we generate any revenues from product sales. We are not permitted to market or promote our electroporation equipment and product candidates before we receive regulatory approval from the FDA or comparable foreign regulatory authorities. If we do not receive regulatory approval for and successfully commercialize any products, we will not generate any revenues from sales of electroporation equipment and products, and we may not be able to continue our operations.

None of our human vaccine product candidates has been approved for sale, and we may not develop commercially successful vaccine products.

Our human vaccine programs are in the early stages of research and development, and currently include vaccine product candidates in discovery, pre-clinical studies and Phase I clinical studies. There is limited data regarding the efficiency of DNA vaccines compared with conventional vaccines, and we must conduct a substantial amount of additional research and development before any regulatory authority will approve any of our vaccine product candidates. The success of our efforts to develop and commercialize our vaccine product candidates could fail for a number of reasons. For example, we could experience delays in product development and clinical trials. Our vaccine product candidates could be found to be ineffective or unsafe, or otherwise fail to receive necessary regulatory clearances. The products, if safe and effective, could be difficult to manufacture on a large scale or uneconomical to market, or our competitors could develop superior vaccine products more quickly and efficiently or more effectively market their competing products.

In addition, adverse events, or the perception of adverse events, relating to vaccines and vaccine delivery technologies may negatively impact our ability to develop commercially successful vaccine products. For example, pharmaceutical companies have been subject to claims that the use of some pediatric vaccines has caused personal injuries, including brain damage, central nervous system damage and autism. These and other claims may influence public perception of the use of vaccine products and could result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approval of our potential products.

We will need substantial additional capital to develop our electroporation-based DNA vaccine delivery technology and vaccine and other product candidates and for our future operations.

Conducting the costly and time consuming research, pre-clinical and clinical testing necessary to obtain regulatory approvals and bring our vaccine delivery technology and product candidates to market will require a commitment of substantial funds in excess of our current capital. Our future capital requirements will depend on many factors, including, among others: the progress of our current and new product development programs; the progress, scope and results of our pre-clinical and clinical testing; the time and cost involved in obtaining regulatory approvals; the cost of manufacturing our products and product candidates; the cost of prosecuting, enforcing and defending against patent infringement claims and other intellectual property rights; competing technological and market developments; and our ability and costs to establish and maintain collaborative and other arrangements with third parties to assist in potentially bringing our products to market.

Additional financing may not be available on acceptable terms, or at all. Domestic and international capital markets have been experiencing heightened volatility and turmoil, making it more difficult to raise capital through the issuance of equity securities. Furthermore, as a result of the recent volatility in the capital markets, the cost and availability of credit has been and may continue to be adversely affected by illiquid credit markets and wider credit spreads. Concern about the stability of the markets generally and the strength of counterparties specifically has led many lenders and institutional investors to reduce, and in some cases cease to provide, funding to borrowers. To the extent we are able to raise additional capital through the sale of equity securities or we issue securities in connection with another transaction, the ownership position of existing stockholders could be substantially diluted. If additional funds are raised through the issuance of preferred stock or debt securities, these securities are likely to have rights, preferences and privileges senior to our common stock and may involve significant fees, interest expense, restrictive covenants and the granting of security interests in our assets. Fluctuating interest rates could also increase the costs of any debt financing we may obtain. Raising capital through a licensing or other transaction involving our intellectual property could require us to relinquish valuable intellectual property rights and thereby sacrifice long term value for short-term liquidity.

Our failure to successfully address ongoing liquidity requirements would have a substantially negative impact on our business. If we are unable to obtain additional capital on acceptable terms when needed, we may need to take actions that adversely affect our business, our stock price and our ability to achieve cash flow in the future, including possibly surrendering our rights to some technologies or product opportunities, delaying our clinical trials or curtailing or ceasing operations.

 

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If we are unable to attract and retain key personnel and advisors, it may adversely affect our ability to obtain financing, pursue collaborations or develop or market our product candidates.

To pursue our business strategy, we will need to attract and retain qualified scientific personnel and managers, including personnel with expertise in clinical trials, government regulation, manufacturing, marketing and other areas. Competition for qualified personnel is intense among companies, academic institutions and other organizations. If we are unable to attract and retain key personnel and advisors, it may negatively affect our ability to successfully develop, test, commercialize and market our products and product candidates.

We face intense and increasing competition and many of our competitors have significantly greater resources and experience.

Many other companies are pursuing other forms of treatment or prevention for diseases that we target. For example, many of our competitors are working on developing and testing H5N1, H1N1 and universal influenza vaccines, and several H1N1 vaccines developed by our competitors have been approved for human use. Our competitors and potential competitors include large pharmaceutical and medical device companies and more established biotechnology companies. These companies have significantly greater financial and other resources and greater expertise than us in research and development, securing government contracts and grants to support research and development efforts, manufacturing, pre-clinical and clinical testing, obtaining regulatory approvals and marketing. This may make it easier for them to respond more quickly than us to new or changing opportunities, technologies or market needs. Many of these competitors operate large, well-funded research and development programs and have significant products approved or in development. Small companies may also prove to be significant competitors, particularly through collaborative arrangements with large pharmaceutical companies or through acquisition or development of intellectual property rights. Our potential competitors also include academic institutions, governmental agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for product and clinical development and marketing. Research and development by others may seek to render our technologies or products obsolete or noncompetitive.

If we lose or are unable to secure collaborators or partners, or if our collaborators or partners do not apply adequate resources to their relationships with us, our product development and potential for profitability will suffer.

We have entered into, or may enter into, distribution, co-promotion, partnership, sponsored research and other arrangements for development, manufacturing, sales, marketing and other commercialization activities relating to our products. For example, we have entered into a license and collaboration agreement with Merck. The amount and timing of resources applied by our collaborators are largely outside of our control.

Wyeth terminated one of our existing collaboration agreements. If any of our other current or future collaborators breaches or terminates our agreements, or fails to conduct our collaborative activities in a timely manner, our commercialization of products could be diminished or blocked completely. It is possible that collaborators will change their strategic focus, pursue alternative technologies or develop alternative products, either on their own or in collaboration with others. Further, we may be forced to fund programs that were previously funded by our collaborators, and we may not have, or be able to access, the necessary funding. The effectiveness of our partners, if any, in marketing our products will also affect our revenues and earnings.

We desire to enter into new collaborative agreements. However, we may not be able to successfully negotiate any additional collaborative arrangements and, if established, these relationships may not be scientifically or commercially successful. Our success in the future depends in part on our ability to enter into agreements with other highly-regarded organizations. This can be difficult due to internal and external constraints placed on these organizations. Some organizations may have insufficient administrative and related infrastructure to enable collaborations with many companies at once, which can extend the time it takes to develop, negotiate and implement a collaboration. Once news of discussions regarding possible collaborations are known in the medical community, regardless of whether the news is accurate, failure to announce a collaborative agreement or the entity’s announcement of a collaboration with another entity may result in adverse speculation about us, resulting in harm to our reputation and our business.

Disputes could also arise between us and our existing or future collaborators, as to a variety of matters, including financial and intellectual property matters or other obligations under our agreements. These disputes could be both expensive and time-consuming and may result in delays in the development and commercialization of our products or could damage our relationship with a collaborator.

 

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A small number of licensing partners and government contracts account for a substantial portion of our revenue.

We currently derive, and in the past we have derived, a significant portion of our revenue from a limited number of licensing partners and government grants and contracts. For example, during the quarter ended March 31, 2010, the National Institute of Allergy and Infectious Diseases (NIAID), the PATH Malaria Vaccine Initiative (MVI) and the Department of Defense (US Army grant) accounted for approximately 61%, 17% and 15% of our consolidated revenue, respectively. If we fail to sign additional future contracts with major licensing partners and the government, if a contract is delayed or deferred, or if an existing contract expires or is cancelled and we fail to replace the contract with new business, our revenue would be adversely affected.

We have agreements with government agencies, which are subject to termination and uncertain future funding.

We have entered into agreements with government agencies, such as the NIAID and the US Army, and we intend to continue entering into these agreements in the future. Our business is partially dependent on the continued performance by these government agencies of their responsibilities under these agreements, including adequate continued funding of the agencies and their programs. We have no control over the resources and funding that government agencies may devote to these agreements, which may be subject to annual renewal and which generally may be terminated by the government agencies at any time.

Government agencies may fail to perform their responsibilities under these agreements, which may cause them to be terminated by the government agencies. In addition, we may fail to perform our responsibilities under these agreements. Many of our government agreements are subject to audits which may occur several years after the period to which the audit relates. If an audit identifies significant unallowable costs, we could incur a material charge to our earnings or reduction in our cash position. As a result, we may be unsuccessful entering or ineligible to enter into future government agreements.

Our quarterly operating results may fluctuate significantly.

We expect our operating results to be subject to quarterly fluctuations. Our net loss and other operating results will be affected by numerous factors, including:

 

   

variations in the level of expenses related to our electroporation equipment, product candidates or future development programs;

 

   

merger integration expenses;

 

   

addition or termination of clinical trials or funding support;

 

   

any intellectual property infringement lawsuit in which we may become involved;

 

   

any legal claims that may be asserted against us or any of our officers;

 

   

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

 

   

our execution of any collaborative, licensing or similar arrangements, and the timing of payments we may make or receive under these arrangements; and

 

   

if any of our products receives regulatory approval, the levels of underlying demand for our products.

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

If we are unable to obtain FDA approval of our products, we will not be able to commercialize them in the United States.

We need FDA approval prior to marketing our electroporation equipment and products in the United States. If we fail to obtain FDA approval to market our electroporation equipment and product candidates, we will be unable to sell our products in the United States, which will significantly impair our ability to generate any revenues.

This regulatory review and approval process, which includes evaluation of pre-clinical studies and clinical trials of our products as well as the evaluation of our manufacturing processes and our third-party contract manufacturers’ facilities, is lengthy, expensive

 

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and uncertain. To receive approval, we must, among other things, demonstrate with substantial evidence from well-controlled clinical trials that our electroporation equipment and product candidates are both safe and effective for each indication for which approval is sought. Satisfaction of the approval requirements typically takes several years and the time needed to satisfy them may vary substantially, based on the type, complexity and novelty of the product. We do not know if or when we might receive regulatory approvals for our electroporation equipment and any of our product candidates currently under development. Moreover, any approvals that we obtain may not cover all of the clinical indications for which we are seeking approval, or could contain significant limitations in the form of narrow indications, warnings, precautions or contra-indications with respect to conditions of use. In such event, our ability to generate revenues from such products would be greatly reduced and our business would be harmed.

The FDA has substantial discretion in the approval process and may either refuse to consider our application for substantive review or may form the opinion after review of our data that our application is insufficient to allow approval of our electroporation equipment and product candidates. If the FDA does not consider or approve our application, it may require that we conduct additional clinical, pre-clinical or manufacturing validation studies and submit that data before it will reconsider our application. Depending on the extent of these or any other studies, approval of any applications that we submit may be delayed by several years, or may require us to expend more resources than we have available. It is also possible that additional studies, if performed and completed, may not be successful or considered sufficient by the FDA for approval or even to make our applications approvable. If any of these outcomes occur, we may be forced to abandon one or more of our applications for approval, which might significantly harm our business and prospects.

It is possible that none of our products or any product we may seek to develop in the future will ever obtain the appropriate regulatory approvals necessary for us or our collaborators to commence product sales. Any delay in obtaining, or an inability to obtain, applicable regulatory approvals would prevent us from commercializing our products, generating revenues and achieving and sustaining profitability.

Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.

Clinical testing is expensive and can take many years to complete, and its outcome is uncertain. Failure can occur at any time during the clinical trial process. The results of pre-clinical studies and early clinical trials of our products may not be predictive of the results of later-stage clinical trials. Results from one study may not be reflected or supported by the results of similar studies. Results of an animal study may not be indicative of results achievable in human studies. Human-use equipment and product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through pre-clinical studies and initial clinical testing. The time required to obtain approval by the FDA and similar foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials, depending upon numerous factors. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change. We have not obtained regulatory approval for any human-use products.

Our products could fail to complete the clinical trial process for many reasons, including the following:

 

   

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

 

   

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

 

   

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

 

   

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

 

   

we may be unable to demonstrate that our electroporation equipment and a product candidate presents an advantage over existing therapies, or over placebo in any indications for which the FDA requires a placebo-controlled trial;

 

   

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

 

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the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a new drug application or other submission or to obtain regulatory approval in the United States or elsewhere;

 

   

the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of us or third-party manufacturers with which we or our collaborators contract for clinical and commercial supplies; and

 

   

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

Delays in the commencement or completion of clinical testing could result in increased costs to us and delay or limit our ability to generate revenues.

Delays in the commencement or completion of clinical testing could significantly affect our product development costs. We do not know whether planned clinical trials will begin on time or be completed on schedule, if at all. In addition, ongoing clinical trials may not be completed on schedule, or at all. The commencement and completion of clinical trials can be delayed for a number of reasons, including delays related to:

 

   

obtaining regulatory approval to commence a clinical trial;

 

   

adverse results from third party clinical trials involving gene based therapies and the regulatory response thereto;

 

   

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

 

   

future bans or stricter standards imposed on gene based therapy clinical trials;

 

   

manufacturing sufficient quantities of our electroporation equipment and product candidates for use in clinical trials;

 

   

obtaining institutional review board, or IRB, approval to conduct a clinical trial at a prospective site;

 

   

slower than expected recruitment and enrolment of patients to participate in clinical trials for a variety of reasons, including competition from other clinical trial programs for similar indications;

 

   

retaining patients who have initiated a clinical trial but may be prone to withdraw due to side effects from the therapy, lack of efficacy or personal issues, or who are lost to further follow-up; and

 

   

collecting, reviewing and analyzing our clinical trial data.

Clinical trials may also be delayed as a result of ambiguous or negative interim results. In addition, a clinical trial may be suspended or terminated by us, the FDA, the IRB overseeing the clinical trial at issue, any of our clinical trial sites with respect to that site, or other regulatory authorities due to a number of factors, including:

 

   

failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;

 

   

inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;

 

   

unforeseen safety issues; and

 

   

lack of adequate funding to continue the clinical trial.

If we experience delays in completion of, or if we terminate, any of our clinical trials, the commercial prospects for our electroporation equipment and our product candidates may be harmed and our ability to generate product revenues will be delayed. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Further, delays in the commencement or completion of clinical trials may adversely affect the trading price of our common stock.

 

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

We and our collaborators have entered into agreements with contract research organizations (“CROs”) to provide monitors for and to manage data for our on-going clinical programs. We and the CROs conducting clinical trials for our electroporation equipment and product candidates are required to comply with current good clinical practices, or GCPs, regulations and guidelines enforced by the FDA for all of our products in clinical development. The FDA enforces GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or the CROs conducting clinical trials of our product candidates fail to comply with applicable GCPs, the clinical data generated in the clinical trials may be deemed unreliable and the FDA may require additional clinical trials before approving any marketing applications.

If any relationships with CROs terminate, we or our collaborators may not be able to enter into arrangements with alternative CROs. In addition, these third- party CROs are not our employees, and we cannot control whether or not they devote sufficient time and resources to our on-going clinical programs or perform trials efficiently. These CROs may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical studies or other drug development activities, which could harm our competitive position. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements, or for other reasons, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed. Cost overruns by or disputes with our CROs may significantly increase our expenses.

Even if our products receive regulatory approval, they may still face future development and regulatory difficulties.

Even if U.S. regulatory approval is obtained, the FDA may still impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies. This governmental oversight may be particularly strict with respect to gene based therapies. Our products will also be subject to ongoing FDA requirements governing the labeling, packaging, storage, advertising, promotion, recordkeeping and submission of safety and other post-market information. In addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current good manufacturing practices, or cGMP, regulations. If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturer or us, including requiring withdrawal of the product from the market or suspension of manufacturing. If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, a regulatory agency may:

 

   

issue Warning Letters or untitled letters;

 

   

impose civil or criminal penalties;

 

   

suspend regulatory approval;

 

   

suspend any ongoing clinical trials;

 

   

refuse to approve pending applications or supplements to applications filed by us;

 

   

impose restrictions on operations, including costly new manufacturing requirements; or

 

   

seize or detain products or require us to initiate a product recall.

Even if our products receive regulatory approval in the United States, we may never receive approval or commercialize our products outside of the United States.

In order to market any electroporation equipment and product candidates outside of the United States, we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy. Approval procedures vary among countries and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries might differ from that required to obtain FDA approval. The regulatory approval process in other

 

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countries may include all of the risks detailed above regarding FDA approval in the United States as well as other risks. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. Failure to obtain regulatory approval in other countries or any delay or setback in obtaining such approval could have the same adverse effects detailed above regarding FDA approval in the United States. Such effects include the risks that our product candidates may not be approved for all indications requested, which could limit the uses of our product candidates and have an adverse effect on their commercial potential or require costly, post-marketing follow-up studies.

We face potential product liability exposure and, if successful claims are brought against us, we may incur substantial liability.

The use of our electroporation equipment and DNA vaccine candidates in clinical trials and the sale of any products for which we obtain marketing approval expose us to the risk of product liability claims. Product liability claims might be brought against us by consumers, health care providers, pharmaceutical companies or others selling or otherwise coming into contact with our products. For example, pharmaceutical companies have been subject to claims that the use of some pediatric vaccines has caused personal injuries, including brain damage, central nervous system damage and autism, and these companies have incurred material costs to defend these claims. If we cannot successfully defend ourselves against product liability claims, we could incur substantial liabilities. In addition, regardless of merit or eventual outcome, product liability claims may result in:

 

   

decreased demand for our product candidates;

 

   

impairment of our business reputation;

 

   

withdrawal of clinical trial participants;

 

   

costs of related litigation;

 

   

distraction of management’s attention from our primary business;

 

   

substantial monetary awards to patients or other claimants;

 

   

loss of revenues; and

 

   

inability to commercialize our products.

In the United States, the National Childhood Vaccine Injury Act of 1986 (the “Vaccine Act”) was created to provide a federal no-fault system for compensating certain vaccine-related injuries or death by establishing a claims procedure involving the United States Court of Federal Claims and special masters. Litigation is pending before the Supreme Court of the United States to decide whether the Vaccine Act categorically preempts all design-defect claims against vaccine manufacturers, or whether instead the preemption of particular design-defect claims must be decided on a case-by-case basis. If the Supreme Court holds that preemption under the Vaccine Act must be decided on a case-by-case basis, vaccine manufacturers will likely be exposed to greater litigation risk from plaintiffs alleging injuries from vaccines.

We have obtained product liability insurance coverage for our clinical trials, but our insurance coverage may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. On occasion, large judgments have been awarded in class action lawsuits based on products that had unanticipated side effects. A successful product liability claim or series of claims brought against us could cause our stock price to decline and, if judgments exceed our insurance coverage, could adversely affect our business.

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

We currently do not have a sales organization for the marketing, sales and distribution of our electroporation equipment and product candidates. In order to commercialize any products, we must build our marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services. We contemplate establishing our own sales force or seeking third-party partners to sell our products. The establishment and development of our own sales force to market any products we may develop will be expensive and time consuming and could delay any product launch, and we may not be able to

 

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successfully develop this capability. We will also have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel. To the extent we rely on third parties to commercialize our approved products, if any, we will receive less revenues than if we commercialized these products ourselves. In addition, we may have little or no control over the sales efforts of third parties involved in our commercialization efforts. In the event we are unable to develop our own marketing and sales force or collaborate with a third-party marketing and sales organization, we would not be able to commercialize our product candidates which would negatively impact our ability to generate product revenues.

If any of our products for which we receive regulatory approval does not achieve broad market acceptance, the revenues that we generate from their sales will be limited.

The commercial success of our electroporation equipment and product candidates for which we obtain marketing approval from the FDA or other regulatory authorities will depend upon the acceptance of these products by both the medical community and patient population. Coverage and reimbursement of our product candidates by third-party payors, including government payors, generally is also necessary for optimal commercial success. The degree of market acceptance of any of our approved products will depend on a number of factors, including:

 

   

our ability to provide acceptable evidence of safety and efficacy;

 

   

the relative convenience and ease of administration;

 

   

the prevalence and severity of any actual or perceived adverse side effects;

 

   

limitations or warnings contained in a product’s FDA-approved labeling, including, for example, potential “black box” warnings

 

   

availability of alternative treatments;

 

   

pricing and cost effectiveness;

 

   

the effectiveness of our or any future collaborators’ sales and marketing strategies;

 

   

our ability to obtain sufficient third-party coverage or reimbursement; and

 

   

the willingness of patients to pay out of pocket in the absence of third-party coverage.

If our electroporation equipment and product candidates are approved but do not achieve an adequate level of acceptance by physicians, health care payors and patients, we may not generate sufficient revenue from these products, and we may not become or remain profitable. In addition, our efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may never be successful.

We are subject to uncertainty relating to reimbursement policies which, if not favorable to our product candidates, could hinder or prevent our products’ commercial success.

Our ability to commercialize our electroporation equipment and product candidates successfully will depend in part on the extent to which governmental authorities, private health insurers and other third-party payors establish appropriate coverage and reimbursement levels for our product candidates and related treatments. As a threshold for coverage and reimbursement, third-party payors generally require that drug products have been approved for marketing by the FDA. Third-party payors also are increasingly challenging the effectiveness of and prices charged for medical products and services. We may not be able to obtain third-party coverage or reimbursement for our products in whole or in part.

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

In both the United States and certain foreign jurisdictions there have been, and we anticipate there will continue to be, a number of legislative and regulatory changes to the healthcare system that could impact our ability to sell any of our products profitably. In the United States, the Federal government recently passed healthcare reform legislation. While many of the details regarding the implementation of this legislation are yet to be determined, we believe there will be continuing trends towards expanding coverage to more individuals, containing health care costs and improving quality.

The continuing efforts of the government, insurance companies, managed care organizations and other payors of health care services to make and implement healthcare reforms may adversely affect:

 

   

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

 

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our ability to generate revenues and achieve or maintain profitability;

 

   

the availability of capital; and

 

   

our ability to obtain timely approval of our products.

If we fail to comply with applicable healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.

Certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights may be applicable to our business. We could be subject to healthcare fraud and abuse and patient privacy regulation by both the federal government and the states in which we conduct our business, without limitation. The laws that may affect our ability to operate include:

 

   

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

 

   

federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;

 

   

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

 

   

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

 

   

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

Additionally, the compliance environment is changing, with more states, such as California and Massachusetts, mandating implementation of compliance programs, compliance with industry ethics codes, and spending limits, and other states, such as Vermont, Maine, and Minnesota requiring reporting to state governments of gifts, compensation, and other remuneration to physicians. Federal legislation, the Physician Payments Sunshine Act of 2009, has been proposed and is moving forward in Congress. This legislation would require disclosure to the federal government of payments to physicians. These laws all provide for penalties for non-compliance. The shifting regulatory environment, along with the requirement to comply with multiple jurisdictions with different compliance and/or reporting requirements, increases the possibility that a company may run afoul of one or more laws.

If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations. Any penalties, damages, fines, curtailment or restructuring of our operations could adversely affect our ability to operate our business and our financial results. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. Moreover, achieving and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove costly.

 

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If we and the contract manufacturers upon whom we rely fail to produce our systems and product candidates in the volumes that we require on a timely basis, or fail to comply with stringent regulations, we may face delays in the development and commercialization of our electroporation equipment and product candidates.

We manufacture some components of our electroporation systems and utilize the services of contract manufacturers to manufacture the remaining components of these systems and our product supplies for clinical trials. The manufacture of our systems and product supplies requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers often encounter difficulties in production, particularly in scaling up for commercial production. These problems include difficulties with production costs and yields, quality control, including stability of the equipment and product candidates and quality assurance testing, shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations. If we or our manufacturers were to encounter any of these difficulties or our manufacturers otherwise fail to comply with their obligations to us, our ability to provide our electroporation equipment to our partners and products to patients in our clinical trials or to commercially launch a product would be jeopardized. Any delay or interruption in the supply of clinical trial supplies could delay the completion of our clinical trials, increase the costs associated with maintaining our clinical trial program and, depending upon the period of delay, require us to commence new trials at significant additional expense or terminate the trials completely.

In addition, all manufacturers of our products must comply with cGMP requirements enforced by the FDA through its facilities inspection program. These requirements include, among other things, quality control, quality assurance and the generation and maintenance of records and documentation. Manufacturers of our products may be unable to comply with these cGMP requirements and with other FDA, state and foreign regulatory requirements. We have little control over our manufacturers’ compliance with these regulations and standards. A failure to comply with these requirements may result in fines and civil penalties, suspension of production, suspension or delay in product approval, product seizure or recall, or withdrawal of product approval. If the safety of any product is compromised due to our or our manufacturers’ failure to adhere to applicable laws or for other reasons, we may not be able to obtain regulatory approval for or successfully commercialize our products, and we may be held liable for any injuries sustained as a result. Any of these factors could cause a delay of clinical trials, regulatory submissions, approvals or commercialization of our products, entail higher costs or result in our being unable to effectively commercialize our products. Furthermore, if our manufacturers fail to deliver the required commercial quantities on a timely basis, pursuant to provided specifications and at commercially reasonable prices, we may be unable to meet demand for our products and would lose potential revenues.

Our failure to successfully acquire, develop and market additional product candidates or approved products would impair our ability to grow.

We may acquire, in-license, develop and/or market additional products and product candidates. The success of these actions depends partly upon our ability to identify, select and acquire promising product candidates and products.

The process of proposing, negotiating and implementing a license or acquisition of a product candidate or approved product is lengthy and complex. Other companies, including some with substantially greater financial, marketing and sales resources, may compete with us for the license or acquisition of product candidates and approved products. We have limited resources to identify and execute the acquisition or in-licensing of third-party products, businesses and technologies and integrate them into our current infrastructure. Moreover, we may devote resources to potential acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts. We may not be able to acquire the rights to additional product candidates on terms that we find acceptable, or at all.

In addition, future acquisitions may entail numerous operational and financial risks, including:

 

   

exposure to unknown liabilities;

 

   

disruption of our business and diversion of our management’s time and attention to develop acquired products or technologies;

 

   

incurrence of substantial debt or dilutive issuances of securities to pay for acquisitions;

 

   

higher than expected acquisition and integration costs;

 

   

increased amortization expenses;

 

   

difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;

 

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impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and

 

   

inability to retain key employees of any acquired businesses.

Further, any product candidate that we acquire may require additional development efforts prior to commercial sale, including extensive clinical testing and approval by the FDA and applicable foreign regulatory authorities. All product candidates are prone to risks of failure typical of product development, including the possibility that a product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities.

Our business involves the use of hazardous materials and we and our third-party manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.

Our and our third-party manufacturers’ activities involve the controlled storage, use and disposal of hazardous materials, including the components of our product candidates and other hazardous compounds. We and our manufacturers are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. In the event of an accident, state or federal authorities may curtail the use of these materials and interrupt our business operations. If we are subject to any liability as a result of our or our third-party manufacturers’ activities involving hazardous materials, our business and financial condition may be adversely affected.

We may be subject to stockholder litigation, which would harm our business and financial condition.

We may have actions brought against us by stockholders relating to the Merger, past transactions, changes in our stock price or other matters. Any such actions could give rise to substantial damages, and thereby have a material adverse effect on our consolidated financial position, liquidity, or results of operations. Even if an action is not resolved against us, the uncertainty and expense associated with stockholder actions could harm our business, financial condition and reputation. Litigation can be costly, time-consuming and disruptive to business operations. The defense of lawsuits could also result in diversion of our management’s time and attention away from business operations, which could harm our business.

Our results of operations and liquidity needs could be materially affected by market fluctuations and general economic conditions.

Our results of operations could be materially affected by economic conditions generally, both in the U.S. and elsewhere around the world. Recently, concerns over inflation, energy costs, geopolitical issues, the availability and cost of credit, the U.S. mortgage market and a declining residential real estate market in the U.S. have contributed to increased volatility and diminished expectations for the economy and the markets going forward. These factors, combined with volatile oil prices, declining business and consumer confidence and increased unemployment, have precipitated an economic recession. Domestic and international capital markets have also been experiencing heightened volatility and turmoil. These events and the continuing market upheavals may have an adverse effect on us. In the event of a continuing market downturn, our results of operations could be adversely affected. Our future cost of equity or debt capital and access to the capital markets could be adversely affected, and our stock price could decline. There may be disruption in or delay in the performance of our third-party contractors and suppliers. If our contractors, suppliers and partners are unable to satisfy their contractual commitments, our business could suffer. In addition, we maintain significant amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured limits. Given the current instability of financial institutions, we may experience losses on these deposits.

Risks Related to Our Intellectual Property

It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection.

Our commercial success will depend in part on obtaining and maintaining patent, trademark, trade secret, and other intellectual property protection relating to our electroporation equipment and product candidates, as well as successfully defending these intellectual property rights against third-party challenges.

The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in biotechnology patents has emerged to date in the United States. The biotechnology patent situation outside the United States can be even more uncertain depending on the country. Changes in either the patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in our licensed patents, our patents or in third-party patents, nor can we predict the likelihood of our patents surviving a patent validity challenge.

 

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The degree of future protection for our intellectual property rights is uncertain, because legal decision-making can be unpredictable, thereby often times resulting in limited protection, which may not adequately protect our rights or permit us to gain or keep our competitive advantage. For example:

 

   

we, or the parties from whom we have acquired or licensed patent rights, may not have been the first to file the underlying patent applications or the first to make the inventions covered by such patents;

 

   

the named inventors or co-inventors of patents or patent applications that we have licensed or acquired may be incorrect, which may give rise to disputes or invalidate the patents;

 

   

others may independently develop similar or alternative technologies or duplicate any of our products or technologies that may not be covered by our patents, or they may design around our patents;

 

   

pending patent applications may not result in issued patents;

 

   

the issued patents covering our products and technologies may not provide us with any competitive advantages;

 

   

the issued patents may be challenged and invalidated, or rendered unenforceable;

 

   

the issued patents may be subject to reexamination, which could result in a narrowing of the scope of claims or cancellation of claims found unpatentable;

 

   

we may not develop or acquire additional proprietary technologies that are patentable;

 

   

our trademarks may be invalid or subject to a third party’s prior use; or

 

   

our ability to enforce our patent rights will depend on our ability to detect infringement, and litigation to enforce patent rights may not be pursued due to significant financial costs, diversion of resources, and unpredictability of a favorable result or ruling.

We depend, in part, on our licensors and collaborators to protect a portion of our intellectual property rights. In such cases, our licensors and collaborators may be primarily or wholly responsible for the maintenance of patents and prosecution of patent applications relating to important areas of our business. If any of these parties fail to adequately protect these products with issued patents, our business and prospects would be harmed significantly.

We also may rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific collaborators and other advisors may unintentionally or willfully disclose our trade secrets to competitors. Enforcing a claim that a third-party entity illegally obtained and is using any of our trade secrets is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.

If we or our licensors fail to obtain or maintain patent protection or trade secret protection for our product candidates or our technologies, third parties could use our proprietary information, which could impair our ability to compete in the market and adversely affect our ability to generate revenues and attain profitability.

If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.

Other companies may have or may acquire intellectual property rights that could be enforced against us. If they do so, we may be required to alter our technologies, pay licensing fees or cease activities. If our products or technologies infringe the intellectual property rights of others, they could bring legal action against us or our licensors or collaborators claiming damages and seeking to enjoin any activities that they believe infringe their intellectual property rights.

Because patent applications can take many years to issue, there may be currently pending applications unknown to us or reissue applications that may later result in issued patents upon which our products or technologies may infringe. There could also be existing

 

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patents of which we are unaware that our products or technologies may infringe. In addition, if third parties file patent applications or obtain patents claiming products or technologies also claimed by us in pending applications or issued patents, we may have to participate in interference proceedings in the U.S. Patent and Trademark Office to determine priority of invention. If third parties file oppositions in foreign countries, we may also have to participate in opposition proceedings in foreign tribunals to defend the patentability of our filed foreign patent applications.

If a third party claims that we infringe its intellectual property rights, it could cause our business to suffer in a number of ways, including:

 

   

we may become involved in time-consuming and expensive litigation, even if the claim is without merit, the third party’s patent is ultimately invalid or we are ultimately found to have not infringed;

 

   

we may become liable for substantial damages for past infringement if a court decides that our technologies infringe upon a third party’s patent;

 

   

we may be ordered by a court to stop making, selling or licensing our products or technologies without a license from a patent holder, which may not be available on commercially acceptable terms, if at all, or which may require us to pay substantial royalties or grant cross-licenses to our patents; and

 

   

we may have to redesign our products so that they do not infringe upon others’ patent rights, which may not be possible or could require substantial investment or time.

If any of these events occur, our business could suffer and the market price of our common stock may decline.

Risks Related to Our Common Stock

The price of our common stock is expected to be volatile and an investment in our common stock could decline substantially in value.

In light of our small size and limited resources, as well as the uncertainties and risks that can affect our business and industry, our stock price is expected to be highly volatile and can be subject to substantial drops, with or even in the absence of news affecting our business. The following factors, in addition to the other risk factors described in this quarterly report, and the potentially low volume of trades in our common stock, may have a significant impact on the market price of our common stock, some of which are beyond our control:

 

   

developments concerning any research and development, clinical trials, manufacturing, and marketing efforts or collaborations;

 

   

fluctuating public or scientific interest in the potential for influenza pandemic or other applications for our vaccine or other product candidates;

 

   

our announcement of significant acquisitions, strategic collaborations, joint ventures or capital commitments;

 

   

fluctuations in our operating results

 

   

announcements of technological innovations;

 

   

new products or services that we or our competitors offer;

 

   

the initiation, conduct and/or outcome of intellectual property and/or litigation matters;

 

   

changes in financial or other estimates by securities analysts or other reviewers or evaluators of our business;

 

   

conditions or trends in bio-pharmaceutical or other healthcare industries;

 

   

regulatory developments in the United States and other countries;

 

   

negative perception of gene based therapy;

 

   

changes in the economic performance and/or market valuations of other biotechnology and medical device companies;

 

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additions or departures of key personnel;

 

   

sales or other transactions involving our common stock;

 

   

global unrest, terrorist activities, and economic and other external factors; and

 

   

catastrophic weather and/or global disease pandemics.

The stock market in general has recently experienced relatively large price and volume fluctuations. In particular, the market prices of securities of smaller biotechnology and medical device companies have experienced dramatic fluctuations that often have been unrelated or disproportionate to the operating results of these companies. Continued market fluctuations could result in extreme volatility in the price of the common stock, which could cause a decline in the value of the common stock. In addition, price volatility may increase if the trading volume of our common stock remains limited or declines.

Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock.

Our amended and restated certificate of incorporation contains provisions that could delay or prevent a change of control of our company or changes in our board of directors that our stockholders might consider favorable. Some of these provisions include:

 

   

the authority of our board of directors to issue shares of undesignated preferred stock and to determine the rights, preferences and privileges of these shares, without stockholder approval;

 

   

all stockholder actions must be effected at a duly called meeting of stockholders and not by written consent; and

 

   

the elimination of cumulative voting.

In addition, we are governed by the provisions of Section 203 of the Delaware General Corporate Law, which may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock. These and other provisions in our amended and restated certificate of incorporation, amended and restated bylaws and Delaware law could make it more difficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by the then-current board of directors, including to delay or impede a merger, tender offer or proxy contest involving our company. Any delay or prevention of a change of control transaction or changes in our board of directors could cause the market price of our common stock to decline.

We have never paid cash dividends on our common stock and we do not anticipate paying dividends in the foreseeable future.

We have paid no cash dividends on our common stock to date, and we currently intend to retain our future earnings, if any, to fund the development and growth of our business. In addition, the terms of any future debt or credit facility may preclude or limit our ability to pay any dividends. As a result, capital appreciation, if any, of our common stock will be your sole source of potential gain for the foreseeable future.

 

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

Not applicable.

 

Item 3. Default Upon Senior Securities

Not applicable.

 

Item 4. (Removed and Reserved)

 

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Item 5. Other Information

Submission of Matters to a Vote of Security Holders

On May 14, 2010, we held our annual meeting of stockholders, at which our stockholders (i) elected six directors to hold office until the next annual meeting of stockholders, (ii) ratified the appointment of Ernst & Young LLP as our independent registered public accounting firm for the year ending December 31, 2010, (iii) approved an amendment to our 2007 Omnibus Incentive Plan to (A) increase the aggregate number of shares available for grant under the plan by 2,000,000 and (B) provide that the aggregate number of shares available for grant under the plan will be increased on January 1 of each year beginning in 2011 by a number of shares equal to the lesser of (1) 2,055,331 or (2) such lesser number of shares as may be determined by the Board, and (iv) approved an amendment to our Certificate of Incorporation to change our name from “Inovio Biomedical Corporation” to “Inovio Pharmaceuticals, Inc.”. The vote on such matters was as follows:

1. Election of Directors

 

Director

   Votes For    Votes Against    Votes Abstained    Broker Non-Votes

Avtar Dhillon

   35,555,063    0       448,537    26,096,608

Joseph Kim

   34,091,633    0    1,911,967    26,096,608

Simon X. Benito

   34,619,543    0    1,384,057    26,096,608

Morton Collins

   34,616,244    0    1,387,356    26,096,608

David Williams

   34,706,861    0    1,296,739    26,096,608

Keith Wells

   34,181,772    0    1,821,828    26,096,608

2. Ratification of appointment of Ernst & Young LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2010.

 

For

 

Against

 

Abstain

 

Broker Non-Votes

61,640,358

  0   459,850   0

3. Approval of an amendment to our 2007 Omnibus Incentive Plan to (i) increase the aggregate number of shares available for grant under the plan by 2,000,000 and (ii) provide that the aggregate number of shares available for grant under the plan will be increased on January 1 of each year beginning in 2011 by a number of shares equal to the lesser of (1) 2,055,331 or (2) such lesser number of shares as may be determined by the Board.

 

For

 

Against

 

Abstain

  

Broker Non-Votes

31,254,645

  4,748,955   0    26,096,608

4. Approval of an amendment to our Certificate of Incorporation to change our name from “Inovio Biomedical Corporation” to “Inovio Pharmaceuticals, Inc.”

 

For

 

Against

 

Abstain

  

Broker Non-Votes

61,791,835

  308,372   0    1

Amendment to Certificate of Incorporation

On May 14, 2010, we amended our Certificate of Incorporation to change our name to Inovio Pharmaceuticals, Inc. The Certificate of Amendment to our Certificate of Incorporation effecting such change is filed herewith as Exhibit 3.1(d).

 

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Item 6. Exhibits

 

(a) Exhibits

 

Exhibit
Number

 

Description of Document

  3.1(d)   Certificate of Amendment to the Certificate of Incorporation of Inovio Biomedical Corporation, filed with the Delaware Secretary of State on May 14, 2010.
10.1#   Amended and Restated 2007 Omnibus Incentive Plan
10.2**   License and Collaboration Agreement dated March 24, 2010 between Registrant and VGX International.
31.1   Certification of Chief Executive Officer Pursuant to Item 601(b)(31) of Regulation S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2   Certification of Chief Financial Officer Pursuant to Item 601(b)(31) of Regulation S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1   Certification of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*

 

* This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.
# Indicates management contract or compensatory plan.
** The company has applied with the Secretary of the Securities and Exchange Commission for confidential treatment of certain information pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. Copies of the exhibits including all confidential portions have been filed separately with confidential treatment applications, which may be made available for public inspection pending the Securities and Exchange Commission’s review of the application in accordance with Rule 24b-2.

 

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INOVIO PHARMACEUTICALS, INC.

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.

 

        Inovio Pharmaceuticals, Inc.
Date: May 17, 2010     By:   / S /    J. J OSEPH K IM        
      J. Joseph Kim
      President, Chief Executive Officer and Director
      (Principal Executive Officer)
Date: May 17, 2010     By:   / S /    P ETER K IES        
      Peter Kies
      Chief Financial Officer
      (Principal Financial and Accounting Officer)

 

41

Exhibit 3.1(d)

CERTIFICATE OF AMENDMENT

TO

THE CERTIFICATE OF INCORPORATION

OF

INOVIO BIOMEDICAL CORPORATION

The undersigned, J. Joseph Kim, hereby certifies that:

1. He is the duly elected and acting President and Chief Executive Officer of Inovio Biomedical Corporation, a Delaware corporation.

2. Article FIRST of the Certificate of Incorporation of the corporation is amended and restated in its entirety to read as follows:

“FIRST The name of the corporation is Inovio Pharmaceuticals, Inc. (hereinafter the “Corporation”).”

3. The foregoing amendment was duly adopted in accordance with the provisions of Section 242(b)(1) of the Delaware General Corporation Law.

The undersigned declares that he has caused this certificate to be signed on May 14, 2010.

 

/s/ J. Joseph Kim

J. Joseph Kim

President and Chief Executive Officer

Exhibit 10.1

LOGO

INOVIO BIOMEDICAL CORPORATION

2007 OMNIBUS INCENTIVE PLAN

As Amended

Adopted by the Board of Directors: March 31, 2007

Approved by Stockholders: May 4, 2007

As Amended by the Board of Directors: July 9, 2009

As Approved by Stockholders: August 25, 2009

As Amended by the Board of Directors: March 29, 2010

As Approved by Stockholders: May 14, 2010


INOVIO BIOMEDICAL CORPORATION

2007 OMNIBUS INCENTIVE PLAN

ARTICLE I

PURPOSE AND ADOPTION OF THE PLAN

1.1 Purpose . The purpose of the Inovio Biomedical Corporation 2007 Incentive Plan (as amended from time to time, the “Plan”) is to assist in attracting and retaining highly competent employees, directors and consultants to act as an incentive in motivating selected employees, directors and consultants of the Company and its Subsidiaries to achieve long-term corporate objectives and to enable stock-based and cash-based incentive awards to qualify as performance-based compensation for purposes of the tax deduction limitations under Section 162(m) of the Code.

1.2 Adoption and Term . The Plan has been approved by the Board to be effective as of March 31, 2007, subject to the approval of the stockholders of the Company. The Plan shall remain in effect until terminated by action of the Board; provided, however, that no Awards may be granted hereunder after the tenth anniversary of its initial effective date.

ARTICLE II

DEFINITIONS

For the purpose of this Plan, capitalized terms shall have the following meanings:

2.1 Award means any one or a combination of Non-Qualified Stock Options or Incentive Stock Options described in Article VI, Stock Appreciation Rights described in Article VI, Restricted Shares and Restricted Stock Units described in Article VII, Performance Awards described in Article VIII, other stock-based Awards described in Article IX, short-term cash incentive Awards described in Article X or any other Award made under the terms of the Plan.

2.2 Award Agreement means a written agreement between the Company and a Participant or a written acknowledgment from the Company to a Participant specifically setting forth the terms and conditions of an Award granted under the Plan.

2.3 Assumed means that pursuant to a Merger either (i) the Award is expressly affirmed by the Company, (ii) the contractual obligations represented by the Award are expressly assumed (and not simply by operation of law) by the successor entity or its parent in connection with the Merger with appropriate adjustments to the number and type of securities of the successor entity or its parent subject to the Award and the exercise or purchase price thereof which at least preserves the compensation element of the Award existing at the time of the Merger as determined in accordance with the instruments evidencing the agreement to assume the Award, or (iii) the Award is otherwise to continue in effect following the Merger.

 

1


2.4 Award Period means, with respect to an Award, the period of time, if any, set forth in the Award Agreement during which specified target performance goals must be achieved or other conditions set forth in the Award Agreement must be satisfied.

2.5 Beneficiary means an individual, trust or estate who or which, by a written designation of the Participant filed with the Company, or if no such written designation is filed, by operation of law, succeeds to the rights and obligations of the Participant under the Plan and the Award Agreement upon the Participant’s death.

2.6 Board means the Board of Directors of the Company.

2.7 Change in Control means, and shall be deemed to have occurred upon the occurrence of, any one of the following events:

(a) The acquisition in one or more transactions, other than from the Company, by any individual, entity or group (within the meaning of Section 13(d)(3) or 14(d)(2) of the Exchange Act), other than the Company, a Subsidiary or any employee benefit plan (or related trust) sponsored or maintained by the Company or a Subsidiary, of beneficial ownership (within the meaning of Rule 13d-3 promulgated under the Exchange Act) of a number of Company Voting Securities in excess of 25% of the Company Voting Securities unless such acquisition has been approved by the Board;

(b) Any election has occurred of persons to the Board that causes two-thirds of the Board to consist of persons other than (i) persons who were members of the Board on the effective date of the Plan and (ii) persons who were nominated for elections as members of the Board at a time when two-thirds of the Board consisted of persons who were members of the Board on the effective date of the Plan, provided, however, that any person nominated for election by a Board at least two-thirds of whom constituted persons described in clauses (i) and/or (ii) or by persons who were themselves nominated by such Board shall, for this purpose, be deemed to have been nominated by a Board composed of persons described in clause (i);

(c) The consummation ( i.e. closing) of a reorganization, merger or consolidation involving the Company, unless, following such reorganization, merger or consolidation, all or substantially all of the individuals and entities who were the respective beneficial owners of the Outstanding Common Stock and Company Voting Securities immediately prior to such reorganization, merger or consolidation, following such reorganization, merger or consolidation beneficially own, directly or indirectly, more than seventy five percent (75%) of, respectively, the then outstanding shares of common stock and the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors or trustees, as the case may be, of the entity resulting from such reorganization, merger or consolidation in substantially the same proportion as their ownership of the Outstanding Common Stock and Company Voting Securities immediately prior to such reorganization, merger or consolidation, as the case may be;

(d) The consummation ( i.e. closing) of a sale or other disposition of all or substantially all the assets of the Company, unless, following such sale or disposition, all or substantially all of the individuals and entities who were the respective beneficial owners of the

 

2


Outstanding Common Stock and Company Voting Securities immediately prior to such reorganization, merger or consolidation, following such reorganization, merger or consolidation beneficially own, directly or indirectly, more than seventy five percent (75%) of, respectively, the then outstanding shares of common stock and the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors or trustees, as the case may be, of the entity purchasing such assets in substantially the same proportion as their ownership of the Outstanding Common Stock and Company Voting Securities immediately prior to such sale or disposition, as the case may be; or

(e) a complete liquidation or dissolution of the Company.

2.8 Code means the Internal Revenue Code of 1986, as amended. References to a section of the Code shall include that section and any comparable section or sections of any future legislation that amends, supplements or supersedes said section.

2.9 Committee means the Compensation Committee of the Board.

2.10 Company means Inovio Biomedical Corporation and its successors.

2.11 Common Stock means the common stock of the Company, par value $0.001 per share.

2.12 Company Voting Securities means the combined voting power of all outstanding voting securities of the Company entitled to vote generally in the election of directors to the Board.

2.13 Date of Grant means the date designated by the Committee as the date as of which it grants an Award, which shall not be earlier than the date on which the Committee approves the granting of such Award.

2.14 Dividend Equivalent Account means a bookkeeping account in accordance with under Section 11.17 and related to an Award that is credited with the amount of any cash dividends or stock distributions that would be payable with respect to the shares of Common Stock subject to such Awards had such shares been outstanding shares of Common Stock.

2.15 Exchange Act means the Securities Exchange Act of 1934, as amended.

2.16 Exercise Price means, with respect to a Stock Appreciation Right, the amount established by the Committee in the Award Agreement which is to be subtracted from the Fair Market Value on the date of exercise in order to determine the amount of the payment to be made to the Participant, as further described in Section 6.02(b).

2.17 Fair Market Value means, on any date, (i) the closing sale price of a share of Common Stock, as reported on the American Stock Exchange (or other established stock exchange on which the Common Stock is regularly traded) on such date or, if there were no sales on such date, on the last date preceding such date on which a sale was reported; or (ii) if shares of Common Stock are not listed for trading on an established stock exchange, Fair Market Value shall be determined by the Committee in good faith.

 

3


2.18 Incentive Stock Option means a stock option within the meaning of Section 422 of the Code.

2.19 Merger means any merger, reorganization, consolidation, exchange, transfer of assets or other transaction having similar effect involving the Company.

2.20 Non-Qualified Stock Option means a stock option which is not an Incentive Stock Option.

2.21 Options means all Non-Qualified Stock Options and Incentive Stock Options granted at any time under the Plan.

2.22 Outstanding Common Stock means, at any time, the issued and outstanding shares of Common Stock.

2.23 Participant means a person designated to receive an Award under the Plan in accordance with Section 5.01.

2.24 Performance Awards means Awards granted in accordance with Article VIII.

2.25 Performance Goals are based on one or more of the following measures and intended to comply with the performance-based compensation exception under Code Section 162(m):

 

   

Net earnings or net income (before or after taxes)

 

   

Earnings per share or earnings per share growth, total units, or unit growth

 

   

Net sales, sales growth, total revenue, or revenue growth

 

   

Net operating profit

 

   

Return measures (including, but not limited to, return on assets, capital, invested capital, equity, sales, or revenue)

 

   

Cash flow (including, but not limited to, operating cash flow, free cash flow, cash flow return on equity, and cash flow return on investment)

 

   

Earnings before or after taxes, interest, depreciation, and/or amortization

 

   

Gross or operating margins

 

   

Productivity ratios

 

   

Share price or relative share price (including, but not limited to, growth measures and total stockholder return)

 

   

Expense targets

 

4


   

Margins

 

   

Operating efficiency

 

   

Market share or change in market share

 

   

Customer retention or satisfaction

 

   

Working capital targets

 

   

Completion of strategic financing goals, acquisitions or alliances and clinical progress

 

   

Company project milestones

 

   

Economic value added or EVA® (net operating profit after tax minus the sum of capital multiplied by the cost of capital)

2.26 Plan has the meaning given to such term in Section 1.01.

2.27 Purchase Price , with respect to Options, shall have the meaning set forth in Section 6.01(b).

2.28 Restricted Shares means Common Stock subject to restrictions imposed in connection with Awards granted under Article VII.

2.29 Restricted Stock Unit means a unit representing the right to receive Common Stock or the value thereof in the future subject to restrictions imposed in connection with Awards granted under Article VII.

2.30 Rule 16b-3 means Rule 16b-3 promulgated by the Securities and Exchange Commission under Section 16 of the Exchange Act, as the same may be amended from time to time, and any successor rule.

2.31 Stock Appreciation Rights means awards granted in accordance with Article VI.

2.32 Subsidiary means a subsidiary of the Company within the meaning of Section 424(f) of the Code.

2.33 Termination of Service means the voluntary or involuntary termination of a Participant’s service as an employee, director or consultant with the Company or a Subsidiary for any reason, including death, disability, retirement or as the result of the divestiture of the Participant’s employer or any similar transaction in which the Participant’s employer ceases to be the Company or one of its Subsidiaries. Whether entering military or other government service shall constitute Termination of Service, or whether and when a Termination of Service shall occur as a result of disability, shall be determined in each case by the Committee in its sole discretion.

 

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ARTICLE III

ADMINISTRATION

3.1 Committee .

(a) Duties and Authority . The Plan shall be administered by the Committee and the Committee shall have exclusive and final authority in each determination, interpretation or other action affecting the Plan and its Participants. The Committee shall have the sole discretionary authority to interpret the Plan, to establish and modify administrative rules for the Plan, to impose such conditions and restrictions on Awards as it determines appropriate, and to make all factual determinations with respect to and take such steps in connection with the Plan and Awards granted hereunder as it may deem necessary or advisable. The Committee shall not, however, have or exercise any discretion that would disqualify amounts payable under Article X as performance-based compensation for purposes of Section 162(m) of the Code. The Committee may delegate such of its powers and authority under the Plan as it deems appropriate to a subcommittee of the Committee or designated officers or employees of the Company. In addition, the full Board may exercise any of the powers and authority of the Committee under the Plan. In the event of such delegation of authority or exercise of authority by the Board, references in the Plan to the Committee shall be deemed to refer, as appropriate, to the delegate of the Committee or the Board. Actions taken by the Committee or any subcommittee thereof, and any delegation by the Committee to designated officers or employees, under this Section 3.01 shall comply with Section 16(b) of the Exchange Act, the performance-based provisions of Section 162(m) of the Code, and the regulations promulgated under each of such statutory provisions, or the respective successors to such statutory provisions or regulations, as in effect from time to time, to the extent applicable.

(b) Indemnification . Each person who is or shall have been a member of the Board or the Committee, or an officer or employee of the Company to whom authority was delegated in accordance with the Plan shall be indemnified and held harmless by the Company against and from any loss, cost, liability, or expense that may be imposed upon or reasonably incurred by such individual in connection with or resulting from any claim, action, suit, or proceeding to which he or she may be a party or in which he or she may be involved by reason of any action taken or failure to act under the Plan and against and from any and all amounts paid by him or her in settlement thereof, with the Company’s approval, or paid by him or her in satisfaction of any judgment in any such action, suit, or proceeding against him or her, provided he or she shall give the Company an opportunity, at its own expense, to handle and defend the same before he or she undertakes to handle and defend it on his or her own behalf; provided, however, that the foregoing indemnification shall not apply to any loss, cost, liability, or expense that is a result of his or her own willful misconduct. The foregoing right of indemnification shall not be exclusive of any other rights of indemnification to which such persons may be entitled under the Company’s Certificate of Incorporation or Bylaws, conferred in a separate agreement with the Company, as a matter of law, or otherwise, or any power that the Company may have to indemnify them or hold them harmless.

 

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ARTICLE IV

SHARES

4.1 Number of Shares Issuable . ( as amended May 14, 2010 ) The maximum aggregate number of shares of Common Stock which may be issued pursuant to Awards shall be 5,750,000 shares of Common Stock, and commencing with the first business day of each calendar year beginning with January 1, 2011, such maximum aggregate number of shares of Common Stock shall be increased by a number equal to the lesser of (i) 2,055,331 or (ii) such lesser number of shares of Common Stock as may be determined by the Board. No more than 5,750,000 shares of Common Stock may be issued under the Plan as Incentive Stock Options, and such number shall not be subject to annual adjustment as described above. The foregoing share limits shall be subject to adjustment in accordance with Section 11.07. The shares to be offered under the Plan shall be authorized and unissued Common Stock, or issued Common Stock that shall have been reacquired by the Company.

4.2 Shares Subject to Terminated Awards . Common Stock covered by any unexercised portions of terminated or forfeited Options (including canceled Options) granted under Article VI, Common Stock forfeited as provided in Section 7.02(a), Stock Units and other stock-based Awards terminated or forfeited as provided in Article IX, and Common Stock subject to any Awards that are otherwise surrendered by the Participant may again be subject to new Awards under the Plan. Shares of Common Stock surrendered to or withheld by the Company in payment or satisfaction of the Purchase Price of an Option or tax withholding obligation with respect to an Award shall be available for the grant of new Awards under the Plan. In the event of the exercise of Stock Appreciation Rights, whether or not granted in tandem with Options, only the number of shares of Common Stock actually issued in payment of such Stock Appreciation Rights shall be charged against the number of shares of Common Stock available for the grant of Awards hereunder.

ARTICLE V

PARTICIPATION

5.1 Eligible Participants . ( as amended May 14, 2010 ) Participants in the Plan shall be such employees, directors and consultants of the Company and its Subsidiaries as the Committee, in its sole discretion, may designate from time to time. The Committee’s designation of a Participant in any year shall not require the Committee to designate such person to receive Awards or grants in any other year. The designation of a Participant to receive Awards or grants under one portion of the Plan does not require the Committee to include such Participant under other portions of the Plan. The Committee shall consider such factors as it deems pertinent in selecting Participants and in determining the type and amount of their respective Awards. Incentive Stock Options may only be granted to employees of the Company or its Subsidiaries. Subject to adjustment in accordance with Section 11.07, in any calendar year, no Participant shall be granted Awards in respect of more than 500,000 shares of Common Stock (whether through grants of Options or Stock Appreciation Rights or other Awards of Common Stock or rights with respect thereto) or cash-based Awards for more than $1,500,000.00.

 

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ARTICLE VI

STOCK OPTIONS AND STOCK APPRECIATION RIGHTS

6.1 Option Awards .

(a) Grant of Options . The Committee may grant, to such Participants as the Committee may select, Options entitling the Participant to purchase shares of Common Stock from the Company in such number, at such price, and on such terms and subject to such conditions, not inconsistent with the terms of this Plan, as may be established by the Committee. The terms of any Option granted under this Plan shall be set forth in an Award Agreement.

(b) Purchase Price of Options . ( as amended May 14, 2009 ) The Purchase Price of each share of Common Stock which may be purchased upon exercise of any Option granted under the Plan shall be determined by the Committee; provided, however, that in no event shall the Purchase Price be less than the Fair Market Value on the Date of Grant. In the case of an Incentive Stock Option granted to a Participant who, on the Date of Grant owns stock representing more than ten percent (10%) of the voting power of all classes of stock of the Company or its Subsidiaries, the per share exercise price shall be not less than one hundred ten percent (110%) of the Fair Market Value per share of Common Stock on the Date of Grant.

(c) Designation of Options . The Committee shall designate, at the time of the grant of each Option, the Option as an Incentive Stock Option or a Non-Qualified Stock Option.

(d) Incentive Stock Option Share Limitation . ( as amended May 14, 2010 ) Notwithstanding an Option’s designation as an Incentive Stock Option, an Option will qualify as an Incentive Stock Option under the Code only to the extent the $100,000 limitation of Section 422(d) of the Code is not exceeded. The $100,000 limitation of Section 422(d) of the Code is calculated based on the aggregate Fair Market Value (measured on the Date of Grant) of the shares of Common Stock subject to Options designated as Incentive Stock Options which first become exercisable in any one calendar year (under the Plan or any other plans of the Company and its Subsidiaries). For purposes of this calculation, Incentive Stock Options shall be taken into account in the order in which they were granted.

(e) Rights As a Stockholder . A Participant or a transferee of an Option pursuant to Section 11.04 shall have no rights as a stockholder with respect to Common Stock covered by an Option until the Participant or transferee shall have become the holder of record of any such shares, and no adjustment shall be made for dividends in cash or other property or distributions or other rights with respect to any such Common Stock for which the record date is prior to the date on which the Participant or a transferee of the Option shall have become the holder of record of any such shares covered by the Option; provided, however, that Participants are entitled to share adjustments to reflect capital changes under Section 11.07.

 

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6.2 Stock Appreciation Rights .

(a) Stock Appreciation Right Awards . The Committee is authorized to grant to any Participant one or more Stock Appreciation Rights. Such Stock Appreciation Rights may be granted either independent of or in tandem with Options granted to the same Participant. Stock Appreciation Rights granted in tandem with Options may be granted simultaneously with, or, in the case of Non-Qualified Stock Options, subsequent to, the grant to such Participant of the related Option; provided however, that: (i) any Option covering any share of Common Stock shall expire and not be exercisable upon the exercise of any Stock Appreciation Right with respect to the same share, (ii) any Stock Appreciation Right covering any share of Common Stock shall expire and not be exercisable upon the exercise of any related Option with respect to the same share, and (iii) an Option and Stock Appreciation Right covering the same share of Common Stock may not be exercised simultaneously. Upon exercise of a Stock Appreciation Right with respect to a share of Common Stock, the Participant shall be entitled to receive an amount equal to the excess, if any, of (A) the Fair Market Value of a share of Common Stock on the date of exercise over (B) the Exercise Price of such Stock Appreciation Right established in the Award Agreement, which amount shall be payable as provided in Section 6.02(c).

(b) Exercise Price . The Exercise Price established under any Stock Appreciation Right granted under this Plan shall be determined by the Committee, but in the case of Stock Appreciation Rights granted in tandem with Options shall not be less than the Purchase Price of the related Option; provided, however, that in no event shall the Exercise Price be less than the Fair Market Value on the Date of Grant. Upon exercise of Stock Appreciation Rights granted in tandem with options, the number of shares subject to exercise under any related Option shall automatically be reduced by the number of shares of Common Stock represented by the Option or portion thereof which are surrendered as a result of the exercise of such Stock Appreciation Rights.

(c) Payment of Incremental Value . Any payment which may become due from the Company by reason of a Participant’s exercise of a Stock Appreciation Right may be paid to the Participant as determined by the Committee (i) all in cash, (ii) all in Common Stock, or (iii) in any combination of cash and Common Stock. In the event that all or a portion of the payment is made in Common Stock, the number of shares of Common Stock delivered in satisfaction of such payment shall be determined by dividing the amount of such payment or portion thereof by the Fair Market Value on the Exercise Date. No fractional share of Common Stock shall be issued to make any payment in respect of Stock Appreciation Rights; if any fractional share would be issuable, the combination of cash and Common Stock payable to the Participant shall be adjusted as directed by the Committee to avoid the issuance of any fractional share.

6.3 Terms of Stock Options and Stock Appreciation Rights .

(a) Conditions on Exercise . An Award Agreement with respect to Options or Stock Appreciation Rights may contain such waiting periods, exercise dates and restrictions on exercise (including, but not limited to, periodic installments) as may be determined by the Committee at the time of grant.

 

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(b) Duration of Options and Stock Appreciation Rights . ( as amended May 14, 2010 ) Options and Stock Appreciation Rights shall terminate upon the first to occur of the following events:

(i) Expiration of the Option or Stock Appreciation Right as provided in the Award Agreement; or

(ii) Termination of the Award in the event of a Participant’s disability, retirement, death or other Termination of Service as provided in the Award Agreement; or

(iii) In the case of an Incentive Stock Option, ten years from the Date of Grant;

(iv) In the case of an Incentive Stock Option granted to a Participant who, at the time the Incentive Stock Option is granted, owns stock representing more than ten percent (10%) of the voting power of all classes of stock of the Company or any of its Subsidiaries, five years from the Date of Grant or

(v) Solely in the case of a Stock Appreciation Right granted in tandem with an Option, upon the expiration of the related Option.

(c) Acceleration or Extension of Exercise Time . The Committee, in its sole discretion, shall have the right (but shall not be obligated), exercisable on or at any time after the Date of Grant, to permit the exercise of an Option or Stock Appreciation Right (i) prior to the time such Option or Stock Appreciation Right would become exercisable under the terms of the Award Agreement, (ii) after the termination of the Option or Stock Appreciation Right under the terms of the Award Agreement, or (iii) after the expiration of the Option or Stock Appreciation Right.

6.4 Exercise Procedures . Each Option and Stock Appreciation Right granted under the Plan shall be exercised prior to the close of business on the expiration date of the Option or Stock Appreciation Right by notice to the Company or by such other method as provided in the Award Agreement or as the Committee may establish or approve from time to time. The Purchase Price of shares purchased upon exercise of an Option granted under the Plan shall be paid in full in cash by the Participant pursuant to the Award Agreement; provided, however, that the Committee may (but shall not be required to) permit payment to be made by delivery to the Company of either (a) Common Stock (which may include Restricted Shares or shares otherwise issuable in connection with the exercise of the Option, subject to such rules as the Committee deems appropriate) or (b) any combination of cash and Common Stock, or (c) such other consideration as the Committee deems appropriate and in compliance with applicable law (including payment under an arrangement constituting a brokerage transaction as permitted under the provisions of Regulation T applicable to cashless exercises promulgated by the Federal Reserve Board, unless prohibited by Section 402 of the Sarbanes-Oxley Act of 2002). In the event that any Common Stock shall be transferred to the Company to satisfy all or any part of the Purchase Price, the part of the Purchase Price deemed to have been satisfied by such transfer of Common Stock shall be equal to the product derived by multiplying the Fair Market Value as of the date of exercise times the number of shares of Common Stock transferred to the Company.

 

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The Participant may not transfer to the Company in satisfaction of the Purchase Price any fractional share of Common Stock. Any part of the Purchase Price paid in cash upon the exercise of any Option shall be added to the general funds of the Company and may be used for any proper corporate purpose. Unless the Committee shall otherwise determine, any Common Stock transferred to the Company as payment of all or part of the Purchase Price upon the exercise of any Option shall be held as treasury shares.

6.5 Change in Control . Unless otherwise provided by the Committee in the applicable Award Agreement, in the event of a Change in Control, all Options outstanding on the date of such Change in Control, and all Stock Appreciation Rights shall become immediately and fully exercisable. The provisions of this Section 6.05 shall not be applicable to any Options or Stock Appreciation Rights granted to a Participant if any Change in Control results from such Participant’s beneficial ownership (within the meaning of Rule 13d-3 under the Exchange Act) of Common Stock or Company Voting Securities.

ARTICLE VII

RESTRICTED SHARES AND RESTRICTED STOCK UNITS

7.1 Award of Restricted Stock and Restricted Stock Units . The Committee may grant to any Participant an Award of Restricted Shares consisting of a specified number of shares of Common Stock issued to the Participant subject to such terms, conditions and forfeiture and transfer restrictions, whether based on performance standards, periods of service, retention by the Participant of ownership of specified shares of Common Stock or other criteria, as the Committee shall establish. The Committee may also grant Restricted Stock Units representing the right to receive shares of Common Stock in the future subject to such terms, conditions and restrictions, whether based on performance standards, periods of service, retention by the Participant of ownership of specified shares of Common Stock or other criteria, as the Committee shall establish. With respect to performance-based Awards of Restricted Shares or Restricted Stock Units intended to qualify as “performance-based” compensation for purposes of Section 162(m) of the Code, performance targets will consist of specified levels of one or more of the Performance Goals. The terms of any Restricted Share and Restricted Stock Unit Awards granted under this Plan shall be set forth in an Award Agreement which shall contain provisions determined by the Committee and not inconsistent with this Plan.

7.2 Restricted Shares .

(a) Issuance of Restricted Shares . As soon as practicable after the Date of Grant of a Restricted Share Award by the Committee, the Company shall cause to be transferred on the books of the Company, or its agent, Common Stock, registered on behalf of the Participant, evidencing the Restricted Shares covered by the Award, but subject to forfeiture to the Company as of the Date of Grant if an Award Agreement with respect to the Restricted Shares covered by the Award is not duly executed by the Participant and timely returned to the Company. All Common Stock covered by Awards under this Article VII shall be subject to the restrictions, terms and conditions contained in the Plan and the Award Agreement entered into by the Participant. Until the lapse or release of all restrictions applicable to an Award of Restricted Shares, the share certificates representing such Restricted Shares may be held in

 

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custody by the Company, its designee, or, if the certificates bear a restrictive legend, by the Participant. Upon the lapse or release of all restrictions with respect to an Award as described in Section 7.02(d), one or more share certificates, registered in the name of the Participant, for an appropriate number of shares as provided in Section 7.02(d), free of any restrictions set forth in the Plan and the Award Agreement shall be delivered to the Participant.

(b) Stockholder Rights . Beginning on the Date of Grant of the Restricted Share Award and subject to execution of the Award Agreement as provided in Section 7.02(a), the Participant shall become a stockholder of the Company with respect to all shares subject to the Award Agreement and shall have all of the rights of a stockholder, including, but not limited to, the right to vote such shares and the right to receive dividends; provided, however, that any Common Stock distributed as a dividend or otherwise with respect to any Restricted Shares as to which the restrictions have not yet lapsed, shall be subject to the same restrictions as such Restricted Shares and held or restricted as provided in Section 7.02(a).

(c) Restriction on Transferability . None of the Restricted Shares may be assigned or transferred (other than by will or the laws of descent and distribution, or to an inter vivos trust with respect to which the Participant is treated as the owner under Sections 671 through 677 of the Code, except to the extent that Section 16 of the Exchange Act limits a Participant’s right to make such transfers), pledged or sold prior to lapse of the restrictions applicable thereto.

(d) Delivery of Shares Upon Vesting . Upon expiration or earlier termination of the forfeiture period without a forfeiture and the satisfaction of or release from any other conditions prescribed by the Committee, or at such earlier time as provided under the provisions of Section 7.04, the restrictions applicable to the Restricted Shares shall lapse. As promptly as administratively feasible thereafter, subject to the requirements of Section 11.05, the Company shall deliver to the Participant or, in case of the Participant’s death, to the Participant’s Beneficiary, one or more share certificates for the appropriate number of shares of Common Stock, free of all such restrictions, except for any restrictions that may be imposed by law.

(e) Forfeiture of Restricted Shares . Subject to Sections 7.02(f) and 7.04, all Restricted Shares shall be forfeited and returned to the Company and all rights of the Participant with respect to such Restricted Shares shall terminate unless the Participant continues in the service of the Company or a Subsidiary as an employee until the expiration of the forfeiture period for such Restricted Shares and satisfies any and all other conditions set forth in the Award Agreement. The Committee shall determine the forfeiture period (which may, but need not, lapse in installments) and any other terms and conditions applicable with respect to any Restricted Share Award.

(f) Waiver of Forfeiture Period . Notwithstanding anything contained in this Article VII to the contrary, the Committee may, in its sole discretion, waive the forfeiture period and any other conditions set forth in any Award Agreement under appropriate circumstances (including the death, disability or retirement of the Participant or a material change in circumstances arising after the date of an Award) and subject to such terms and conditions (including forfeiture of a proportionate number of the Restricted Shares) as the Committee shall deem appropriate.

 

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7.3 Restricted Stock Units .

(a) Settlement of Restricted Stock Units . Payments shall be made to Participants with respect to their Restricted Stock Units as soon as practicable after the Committee has determined that the terms and conditions applicable to such Award have been satisfied or at a later date if distribution has been deferred. Payments to Participants with respect to Restricted Stock Units shall be made in the form of Common Stock, or cash or a combination of both, as the Committee may determine. The amount of any cash to be paid in lieu of Common Stock shall be determined on the basis of the Fair Market Value of the Common Stock on the date any such payment is processed. As to shares of Common Stock which constitute all or any part of such payment, the Committee may impose such restrictions concerning their transferability and/or their forfeiture as may be provided in the applicable Award Agreement or as the Committee may otherwise determine, provided such determination is made on or before the date certificates for such shares are first delivered to the applicable Participant.

(b) Shareholder Rights . Until the lapse or release of all restrictions applicable to an Award of Restricted Stock Units, no shares of Common Stock shall be issued in respect of such Awards and no Participant shall have any rights as a shareholder of the Company with respect to the shares of Common Stock covered by such Award of Restricted Stock Units.

(c) Waiver of Forfeiture Period . Notwithstanding anything contained in this Section 7.03 to the contrary, the Committee may, in its sole discretion, waive the forfeiture period and any other conditions set forth in any Award Agreement under appropriate circumstances (including the death, disability or retirement of the Participant or a material change in circumstances arising after the date of an Award) and subject to such terms and conditions (including forfeiture of a proportionate number of shares issuable upon settlement of the Restricted Stock Units constituting an Award) as the Committee shall deem appropriate.

(d) Deferral of Payment . If approved by the Committee and set forth in the applicable Award Agreement, a Participant may elect to defer the amount payable with respect to the Participant’s Restricted Stock Units in accordance with such terms as may be established by the Committee.

7.4 Change in Control . Unless otherwise provided by the Committee in the applicable Award Agreement, in the event of a Change in Control, all restrictions applicable to Restricted Shares and Restricted Stock Unit Awards shall terminate fully and the Participant shall immediately have the right to the delivery in accordance with Section 7.02(d) of a share certificate or certificates evidencing a number of shares of Common Stock equal to the full number of shares subject to each such Award (in the case of Restricted Stock) or payment in accordance with Section 7.03(a) of a number of shares of Common Stock determined by the Committee, in its discretion, but, in the case of a performance-based or other contingent Award, in no event less than the number of shares payable at the “target” level for each such Award (in the case of Restricted Stock Units). The provisions of this Section 7.04 shall not be applicable to any Restricted Share or Restricted Stock Unit Award granted to a Participant if any Change in Control results from such Participant’s beneficial ownership (within the meaning of Rule 13d-3 under the Exchange Act) of Common Stock or Company Voting Securities.

 

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ARTICLE VIII

PERFORMANCE AWARDS

8.1 Performance Awards .

(a) Award Periods and Calculations of Potential Incentive Amounts . The Committee may grant Performance Awards to Participants. A Performance Award shall consist of the right to receive a payment (measured by the Fair Market Value of a specified number of shares of Common Stock, increases in such Fair Market Value during the Award Period and/or a fixed cash amount) contingent upon the extent to which certain predetermined performance targets have been met during an Award Period. The Award Period shall be two or more fiscal or calendar years as determined by the Committee. The Committee, in its discretion and under such terms as it deems appropriate, may permit newly eligible Participants, such as those who are promoted or newly hired, to receive Performance Awards after an Award Period has commenced.

(b) Performance Targets . Subject to Section 11.18, the performance targets applicable to a Performance Award may include such goals related to the performance of the Company or, where relevant, any one or more of its Subsidiaries or divisions and/or the performance of a Participant as may be established by the Committee in its discretion. In the case of Performance Awards to “covered employees” (as defined in Section 162(m) of the Code), the targets will be limited to specified levels of one or more of the Performance Goals. The performance targets established by the Committee may vary for different Award Periods and need not be the same for each Participant receiving a Performance Award in an Award Period.

(c) Earning Performance Awards . The Committee, at or as soon as practicable after the Date of Grant, shall prescribe a formula to determine the percentage of the Performance Award to be earned based upon the degree of attainment of the applicable performance targets.

(d) Payment of Earned Performance Awards . Subject to the requirements of Section 11.05, payments of earned Performance Awards shall be made in cash or Common Stock, or a combination of cash and Common Stock, in the discretion of the Committee. The Committee, in its sole discretion, may define, and set forth in the applicable Award Agreement, such terms and conditions with respect to the payment of earned Performance Awards as it may deem desirable.

8.2 Termination of Service . In the event of a Participant’s Termination of Service during an Award Period, the Participant’s Performance Awards shall be forfeited except as may otherwise be provided in the applicable Award Agreement.

8.3 Change in Control . Unless otherwise provided by the Committee in the applicable Award Agreement, in the event of a Change in Control, all Performance Awards for all Award Periods shall immediately become fully vested and payable to all Participants and shall be paid to Participants in accordance with Section 8.01(d), within 30 days after such Change in Control. The provisions of this Section 8.03 shall not be applicable to any Performance Award granted to a Participant if any Change in Control results from such Participant’s beneficial ownership (within the meaning of Rule 13d-3 under the Exchange Act) of Common Stock or Company Voting Securities.

 

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ARTICLE IX

OTHER STOCK-BASED AWARDS

9.1 Grant of Other Stock-Based Awards . ( as amended May 14, 2010 ) Other stock-based awards, consisting of stock purchase rights (with or without loans to Participants by the Company containing such terms as the Committee shall determine), Awards of Common Stock, or Awards valued in whole or in part by reference to, or otherwise based on, Common Stock or dividends on Common Stock, may be granted either alone or in addition to or in conjunction with other Awards under the Plan. Subject to the provisions of the Plan, the Committee shall have sole and complete authority to determine the persons to whom and the time or times at which such Awards shall be made, the number of shares of Common Stock to be granted pursuant to such Awards, and all other conditions of the Awards. Any such Award shall be confirmed by an Award Agreement executed by the Committee and the Participant, which Award Agreement shall contain such provisions as the Committee determines to be necessary or appropriate to carry out the intent of this Plan with respect to such Award.

9.2 Terms of Other Stock-Based Awards . In addition to the terms and conditions specified in the Award Agreement, Awards made pursuant to this Article IX shall be subject to the following:

(a) Any Common Stock subject to Awards made under this Article IX may not be sold, assigned, transferred, pledged or otherwise encumbered prior to the date on which the shares are issued, or, if later, the date on which any applicable restriction, performance or deferral period lapses; and

(b) If specified by the Committee in the Award Agreement, the recipient of an Award under this Article IX shall be entitled to receive, currently or on a deferred basis, interest or dividends or dividend equivalents with respect to the Common Stock or other securities covered by the Award; and

(c) The Award Agreement with respect to any Award shall contain provisions dealing with the disposition of such Award in the event of a Termination of Service prior to the exercise, payment or other settlement of such Award, whether such termination occurs because of retirement, disability, death or other reason, with such provisions to take account of the specific nature and purpose of the Award.

ARTICLE X

SHORT-TERM CASH INCENTIVE AWARDS

10.1 Eligibility . Executive officers of the Company who are from time to time determined by the Committee to be “covered employees” for purposes of Section 162(m) of the Code will be eligible to receive short-term cash incentive awards under this Article X.

 

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10.2 Awards .

(a) Performance Targets . The Committee shall establish objective performance targets based on specified levels of one or more of the Performance Goals. Such performance targets shall be established by the Committee on a timely basis to ensure that the targets are considered “preestablished” for purposes of Section 162(m) of the Code.

(b) Amounts of Awards . In conjunction with the establishment of performance targets for a fiscal year, the Committee shall adopt an objective formula (on the basis of percentages of Participants’ salaries, shares in a bonus pool or otherwise) for computing the respective amounts payable under the Plan to Participants if and to the extent that the performance targets are attained. Such formula shall comply with the requirements applicable to performance-based compensation plans under Section 162(m) of the Code and, to the extent based on percentages of a bonus pool, such percentages shall not exceed 100% in the aggregate.

(c) Payment of Awards . Awards will be payable to Participants in cash each year upon prior written certification by the Committee of attainment of the specified performance targets for the preceding fiscal year.

(d) Negative Discretion . Notwithstanding the attainment by the Company of the specified performance targets, the Committee shall have the discretion, which need not be exercised uniformly among the Participants, to reduce or eliminate the award that would be otherwise paid.

(e) Guidelines . The Committee shall adopt from time to time written policies for its implementation of this Article X. Such guidelines shall reflect the intention of the Company that all payments hereunder qualify as performance-based compensation under Section 162(m) of the Code.

(f) Non-Exclusive Arrangement . The adoption and operation of this Article X shall not preclude the Board or the Committee from approving other short-term incentive compensation arrangements for the benefit of individuals who are Participants hereunder as the Board or Committee, as the case may be, deems appropriate and in the best of the Company.

ARTICLE XI

TERMS APPLICABLE GENERALLY TO AWARDS

GRANTED UNDER THE PLAN

11.1 Plan Provisions Control Award Terms . Except as provided in Section 11.16, the terms of the Plan shall govern all Awards granted under the Plan, and in no event shall the Committee have the power to grant any Award under the Plan which is contrary to any of the provisions of the Plan. In the event any provision of any Award granted under the Plan shall conflict with any term in the Plan as constituted on the Date of Grant of such Award, the term in the Plan as constituted on the Date of Grant of such Award shall control. Except as provided in Section 11.03 and Section 11.07, the terms of any Award granted under the Plan may not be changed after the Date of Grant of such Award so as to materially decrease the value of the Award without the express written approval of the holder.

 

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11.2 Award Agreement . No person shall have any rights under any Award granted under the Plan unless and until the Company and the Participant to whom such Award shall have been granted shall have executed and delivered an Award Agreement or received any other Award acknowledgment authorized by the Committee expressly granting the Award to such person and containing provisions setting forth the terms of the Award.

11.3 Modification of Award After Grant . No Award granted under the Plan to a Participant may be modified (unless such modification does not materially decrease the value of the Award) after the Date of Grant except by express written agreement between the Company and the Participant, provided that any such change (a) shall not be inconsistent with the terms of the Plan, and (b) shall be approved by the Committee.

11.4 Limitation on Transfer . Except as provided in Section 7.01(c) in the case of Restricted Shares, a Participant’s rights and interest under the Plan may not be assigned or transferred other than by will or the laws of descent and distribution, and during the lifetime of a Participant, only the Participant personally (or the Participant’s personal representative) may exercise rights under the Plan. The Participant’s Beneficiary may exercise the Participant’s rights to the extent they are exercisable under the Plan following the death of the Participant. Notwithstanding the foregoing, to the extent permitted under Section 16(b) of the Exchange Act with respect to Participants subject to such Section, the Committee may grant Non-Qualified Stock Options that are transferable, without payment of consideration, to immediate family members of the Participant or to trusts or partnerships for such family members, and the Committee may also amend outstanding Non-Qualified Stock Options to provide for such transferability.

11.5 Taxes . The Company shall be entitled, if the Committee deems it necessary or desirable, to withhold (or secure payment from the Participant in lieu of withholding) the amount of any withholding or other tax required by law to be withheld or paid by the Company with respect to any amount payable and/or shares issuable under such Participant’s Award, or with respect to any income recognized upon a disqualifying disposition of shares received pursuant to the exercise of an Incentive Stock Option, and the Company may defer payment or issuance of the cash or shares upon exercise or vesting of an Award unless indemnified to its satisfaction against any liability for any such tax. The amount of such withholding or tax payment shall be determined by the Committee and shall be payable by the Participant at such time as the Committee determines in accordance with the following rules:

(a) The Participant shall have the right to elect to meet his or her withholding requirement (i) by having withheld from such Award at the appropriate time that number of shares of Common Stock, rounded up to the next whole share, whose Fair Market Value is equal to the amount of withholding taxes due, (ii) by direct payment to the Company in cash of the amount of any taxes required to be withheld with respect to such Award or (iii) by a combination of shares and cash.

 

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(b) In the case of Participants who are subject to Section 16 of the Exchange Act, the Committee may impose such limitations and restrictions as it deems necessary or appropriate with respect to the delivery or withholding of shares of Common Stock to meet tax withholding obligations.

11.6 Surrender of Awards . Any Award granted under the Plan may be surrendered to the Company for cancellation on such terms as the Committee and the holder approve. With the consent of the Participant, the Committee may substitute a new Award under this Plan in connection with the surrender by the Participant of an equity compensation award previously granted under this Plan or any other plan sponsored by the Company; provided, however, that no such substitution shall be permitted without the approval of the Company’s stockholders if such approval is required by the rules of any applicable stock exchange.

11.7 Adjustments to Reflect Capital Changes .

(a) Recapitalization . In the event of any corporate event or transaction (including, but not limited to, a change in the Common Stock or the capitalization of the Company) such as a merger, consolidation, reorganization, recapitalization, separation, partial or complete liquidation, stock dividend, stock split, reverse stock split, split up, spin-off, or other distribution of stock or property of the Company, a combination or exchange of Common Stock, dividend in kind, or other like change in capital structure, number of outstanding shares of Common Stock, distribution (other than normal cash dividends) to shareholders of the Company, or any similar corporate event or transaction, the Committee, in order to prevent dilution or enlargement of Participants’ rights under this Plan, shall make equitable and appropriate adjustments and substitutions, as applicable, to or of the number and kind of shares subject to outstanding Awards, the Purchase Price or Exercise Price for such shares, the number and kind of shares available for future issuance under the Plan and the maximum number of shares in respect of which Awards can be made to any Participant in any calendar year, and other determinations applicable to outstanding Awards. The Committee shall have the power and sole discretion to determine the amount of the adjustment to be made in each case.

(b) Merger . ( as amended May 14, 2010 ) Effective upon the consummation of a Merger, all outstanding Awards under the Plan shall terminate. However, all such Awards shall not terminate to the extent they are Assumed in connection with the Merger. The Committee shall have the authority, exercisable either in advance of any actual or anticipated Merger or at the time of an actual Merger and exercisable at the Date of Grant of an Award under the Plan or any time while an Award remains outstanding, to provide for the full or partial automatic vesting and exercisability of one or more outstanding unvested Awards under the Plan and the release from restrictions on transfer and repurchase or forfeiture rights of such Awards in connection with a Merger, on such terms and conditions as the Committee may specify. The Committee also shall have the authority to condition any such Award vesting and exercisability or release from such limitations upon the subsequent Termination of Service of the Participant within a specified period following the effective date of the Merger. The Committee may provide that any Awards so vested or released from such limitations in connection with a Merger shall remain fully exercisable until the expiration or sooner termination of the Award. Any Incentive Stock Option accelerated under this Section 11.7(b) in connection with a Merger shall remain exercisable as an Incentive Stock Option under the Code only to the extent the $100,000 dollar limitation of Section 422(d) is not exceeded.

 

18


(c) Options to Purchase Shares or Stock of Acquired Companies . After any Merger in which the Company or a Subsidiary shall be a surviving corporation, the Committee may grant substituted options under the provisions of the Plan, pursuant to Section 424 of the Code, replacing old options granted under a plan of another party to the Merger whose shares or stock subject to the old options may no longer be issued following the Merger. The foregoing adjustments and manner of application of the foregoing provisions shall be determined by the Committee in its sole discretion. Any such adjustments may provide for the elimination of any fractional shares which might otherwise become subject to any Options.

11.8 No Right to Continued Service . No person shall have any claim of right to be granted an Award under this Plan. Neither the Plan nor any action taken hereunder shall be construed as giving any Participant any right to be retained in the service of the Company or any of its Subsidiaries.

11.9 Awards Not Includable for Benefit Purposes . Payments received by a Participant pursuant to the provisions of the Plan shall not be included in the determination of benefits under any pension, group insurance or other benefit plan applicable to the Participant which is maintained by the Company or any of its Subsidiaries, except as may be provided under the terms of such plans or determined by the Board.

11.10 Governing Law . All determinations made and actions taken pursuant to the Plan shall be governed by the laws of California and construed in accordance therewith.

11.11 No Strict Construction . No rule of strict construction shall be implied against the Company, the Committee, or any other person in the interpretation of any of the terms of the Plan, any Award granted under the Plan or any rule or procedure established by the Committee.

11.12 Compliance with Rule 16b-3 . It is intended that, unless the Committee determines otherwise, Awards under the Plan be eligible for exemption under Rule 16b-3. The Board is authorized to amend the Plan and to make any such modifications to Award Agreements to comply with Rule 16b-3, as it may be amended from time to time, and to make any other such amendments or modifications as it deems necessary or appropriate to better accomplish the purposes of the Plan in light of any amendments made to Rule 16b-3.

11.13 Captions . The captions (i.e., all Section headings) used in the Plan are for convenience only, do not constitute a part of the Plan, and shall not be deemed to limit, characterize or affect in any way any provisions of the Plan, and all provisions of the Plan shall be construed as if no captions have been used in the Plan.

11.14 Severability . Whenever possible, each provision in the Plan and every Award at any time granted under the Plan shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of the Plan or any Award at any time granted under the Plan shall be held to be prohibited by or invalid under applicable law, then (a) such provision shall be deemed amended to accomplish the objectives of the provision as originally written to the fullest extent permitted by law and (b) all other provisions of the Plan and every other Award at any time granted under the Plan shall remain in full force and effect.

 

19


11.15 Amendment and Termination .

(a) Amendment . The Board shall have complete power and authority to amend the Plan at any time; provided, however, that the Board shall not, without the requisite affirmative approval of stockholders of the Company, make any amendment which requires stockholder approval under the Code or under any other applicable law or rule of any stock exchange which lists Common Stock or Company Voting Securities. No termination or amendment of the Plan may, without the consent of the Participant to whom any Award shall theretofore have been granted under the Plan, adversely affect the right of such individual under such Award.

(b) Termination . The Board shall have the right and the power to terminate the Plan at any time. No Award shall be granted under the Plan after the termination of the Plan, but the termination of the Plan shall not have any other effect and any Award outstanding at the time of the termination of the Plan may be exercised after termination of the Plan at any time prior to the expiration date of such Award to the same extent such Award would have been exercisable had the Plan not terminated.

11.16 Foreign Qualified Awards . Awards under the Plan may be granted to such employees of the Company and its Subsidiaries who are residing in foreign jurisdictions as the Committee in its sole discretion may determine from time to time. The Committee may adopt such supplements to the Plan as may be necessary or appropriate to comply with the applicable laws of such foreign jurisdictions and to afford Participants favorable treatment under such laws; provided, however, that no Award shall be granted under any such supplement with terms or conditions inconsistent with the provision set forth in the Plan.

11.17 Dividend Equivalents . For any Award granted under the Plan, the Committee shall have the discretion, upon the Date of Grant or thereafter, to establish a Dividend Equivalent Account with respect to the Award, and the applicable Award Agreement or an amendment thereto shall confirm such establishment. If a Dividend Equivalent Account is established, the following terms shall apply:

(a) Terms and Conditions . Dividend Equivalent Accounts shall be subject to such terms and conditions as the Committee shall determine and as shall be set forth in the applicable Award Agreement. Such terms and conditions may include, without limitation, for the Participant’s Account to be credited as of the record date of each cash dividend on the Common Stock with an amount equal to the cash dividends which would be paid with respect to the number of shares of Common Stock then covered by the related Award if such shares of Common Stock had been owned of record by the Participant on such record date.

(b) Unfunded Obligation . Dividend Equivalent Accounts shall be established and maintained only on the books and records of the Company and no assets or funds of the Company shall be set aside, placed in trust, removed from the claims of the Company’s general creditors, or otherwise made available until such amounts are actually payable as provided hereunder.

 

20


11.18 Adjustment of Performance Goals and Targets . Notwithstanding any provision of the Plan to the contrary, the Committee shall have the authority to adjust any Performance Goal, performance target or other performance-based criteria established with respect to any Award under the Plan if circumstances occur (including, but not limited to, unusual or nonrecurring events, changes in tax laws or accounting principles or practices or changed business or economic conditions) that cause any such Performance Goal, performance target or performance-based criteria to be inappropriate in the judgment of the Committee; provided, that with respect to any Award that is intended to qualify for the “performance-based compensation” exception under Section 162(m) of the Code and the regulations thereunder, any adjustment by the Committee shall be consistent with the requirements of Section 162(m) and the regulations thereunder.

11.19 Legality of Issuance . Notwithstanding any provision of this Plan or any applicable Award Agreement to the contrary, the Committee shall have the sole discretion to impose such conditions, restrictions and limitations (including suspending exercises of Options or Stock Appreciation Rights and the tolling of any applicable exercise period during such suspension) on the issuance of Common Stock with respect to any Award unless and until the Committee determines that such issuance complies with (i) any applicable registration requirements under the Securities Act of 1933 or the Committee has determined that an exemption there from is available, (ii) any applicable listing requirement of any stock exchange on which the Common Stock is listed, and (iii) any other applicable provision of state, federal or foreign law, including foreign securities laws where applicable.

11.20 Restrictions on Transfer . Regardless of whether the offering and sale of Common Stock under the Plan have been registered under the Securities Act of 1933 or have been registered or qualified under the securities laws of any state, the Company may impose restrictions upon the sale, pledge, or other transfer of such Common Stock (including the placement of appropriate legends on stock certificates) if, in the judgment of the Company and its counsel, such restrictions are necessary or desirable to achieve compliance with the provisions of the Securities Act of 1933, the securities laws of any state, the United States or any other applicable foreign law.

11.21 Further Assurances . As a condition to receipt of any Award under the Plan, a Participant shall agree, upon demand of the Company, to do all acts and execute, deliver and perform all additional documents, instruments and agreements which may be reasonably required by the Company, to implement the provisions and purposes of the Plan.

 

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Exhibit 10.2

*** CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT (INDICATED BY ASTERISKS) HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

COLLABORATION AND LICENSE AGREEMENT

BETWEEN

VGX INTERNATIONAL, INC.

(VGXI)

AND

INOVIO BIOMEDICAL CORPORATION

(INO)

 

*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


TABLE OF CONTENTS

 

         Page

1.

 

DEFINITIONS

   1

2.

 

LICENSE GRANT

   4

3.

 

COORDINATION

   5

4.

 

FEES AND ROYALTIES

   6

5.

 

DEVELOPMENT AND MATERIALS

   10

6.

 

MANUFACTURE

   11

7.

 

CONFIDENTIALITY

   12

8.

 

TERM and TERMINATION

   13

9.

 

IMPROVEMENTS TO INVENTION

   15

10.

 

PATENT MAINTENANCE and REIMBURSEMENT

   16

11.

 

INFRINGEMENT and LITIGATION

   16

12.

 

REPRESENTATIONS AND WARRANTIES OF INO; DISCLAIMER OF ADDITIONAL WARRANTIES; INDEMNIFICATION

   17

13.

 

USE OF PARTIES’ NAME

   20

14.

 

ADDITIONAL PROVISIONS

   20

ATTACHMENTS 1-3

 

*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


This Collaboration and License Agreement (“AGREEMENT”) is made and entered into between VGX International Inc. (“VGXI”), a corporation with offices located at Jung-Hun Building, #304, 944-1 Daechi 3-Dong, Gangnam-gu, Seoul, Korea, and Inovio Biomedical Corporation (“INO”), a Delaware corporation having a place of business at 450 Sentry Parkway, Blue Bell, PA 19422.

WHEREAS, INO and VGXI are parties to a R&D Collaboration and License Agreement having an effective date of December 22, 2008 and parties wish to supersede such agreement with this Agreement;

WHEREAS, INO has developed a universal influenza vaccine delivered with electroporation, SynCon TM Universal influenza DNA vaccine in conjunction with electroporation (“VACCINE”), and VGXI desires to develop the VACCINE in certain countries in Asia;

WHEREAS, INO owns certain intellectual property related to the Vaccine and technologies for delivery of the same, including various filed patent applications in the United States and abroad; and

WHEREAS, INO desires to license out its intellectual property rights related to Vaccine and delivery technologies to VGXI in certain countries in Asia, and VGXI desires to compensate INO for such licensed rights;

NOW, THEREFORE, in consideration of the promises and covenants contained in this AGREEMENT, and intending to be legally bound thereby, the parties hereby agree as follows:

 

1. DEFINITIONS

1.1 CALENDAR QUARTER means each three-month period, or any portion thereof, beginning on January 1, April 1, July 1 and October 1.

1.2 CALENDAR YEAR means each 12-month period beginning on January 1.

1.3 DEVELOPMENT PLAN means the plan, as it may be amended from time to time, for the development and/or marketing of the INO LICENSED PRODUCTS in the TERRITORY. The initial DEVELOPMENT PLAN will be provided by the JDC in a timely manner and attached hereto, as Attachment 2. The DEVELOPMENT PLAN shall be regularly updated and amended to this AGREEMENT by the JDC.

1.4 EFFECTIVE DATE means the last date on which VGXI and INO have both fully executed this AGREEMENT.

1.5 EXCLUDED PROCEEDS means all proceeds reasonably and fairly attributable to bona fide (i) debt financing to the extent the debt is not forgiven; (ii) equity (and conditional equity, such as warrants, convertible debt and the like (iii) investments in VGXI at fair market value; (iv) reimbursements of patent prosecution costs and patent

 

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*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


maintenance expenses; (v) reimbursement for the cost of research and/or development services provided on the basis of full-time equivalent efforts of personnel not in excess of commercially reasonable full-time equivalent rates.

1.6 FAIR MARKET VALUE means the cash consideration which VGXI or a sublicensee thereof would realize from an unaffiliated, unrelated buyer in an arm’s length sale of an identical item sold in the same quantity and at the same time and place of the transaction.

1.7 IND APPLICATION means an Investigational New Drug Application filed with the United States Food and Drug Administration under the U.S. Federal Food, Drug and Cosmetic Act prior to administration of a pharmaceutical product to humans; or an analogous application or filing with any analogous agency or Regulatory Authority outside of the United States under any analogous foreign law for the purposes of obtaining permission to conduct human clinical studies.

1.8 MARKETING APPROVAL means the approval of a NDA or a New Drug Application filed with the United States Food & Drug Administration prior to sale of a pharmaceutical product to humans, which grants a sponsor company of the NDA approval for the sale and marketing of a new pharmaceutical in the United States; or the approval of an analogous application with any analogous agency or Regulatory Authority outside of the United States under any analogous foreign law for the purposes of approval of the sale and marketing of a new pharmaceutical in the respective country

1.9 PATENT MAINTENANCE PAYMENT means an annual payment from VGXI to INO that is intended to cover a portion of the annual costs of maintaining the patents related to the territory of Asia excluding Japan (“TERRITORY”) under the INO PATENT RIGHTS, which also includes, among other items, patent office fees, attorneys’ fees, and other patent related out of pocket costs to INO.

1.10 INO LICENSED PRODUCT(S) means product(s) which is/are made, made for, used by, imported by or for, sold by or offered for sale by VGXI and/or any sublicensee(s) of VGXI to unrelated third parties which fall under the scope of the INO PATENT RIGHTS.

1.11 INO PATENT RIGHTS means all of INO’s interest in the rights represented by or issuing from (including all claims referenced within) those United States patents and patent applications listed in Attachment 1, including, in each case, any continuations, continuations-in-part, divisions, provisionals, substitute applications, and any patent issuing therefrom, and any reissues, reexaminations, renewals and/or extensions (including any supplemental patent certificate) based thereon, and any confirmation patent or registration patent or patent of addition based on any such patent, and all foreign counterparts of any of the foregoing.

1.12 FIELD-OF-USE, or FIELD, as used hererin means a limitation on the application or utilization of PATENT RIGHTS to the field of DNA based vaccines against influenza that are delivered to a subject using electroporation, and its use to treat or protect a subject by delivering to such subject along with electroporation.

 

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*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


1.13 SALE means any bona fide transaction for which consideration is received or promised for the sale, use, lease, transfer or other disposition of INO LICENSED PRODUCT(S) to an unrelated third party. A SALE of INO LICENSED PRODUCT(S) shall be deemed completed at the time VGXI or its sublicensee invoices, ships or receives payment for such INO LICENSED PRODUCT(S), whichever occurs first.

1.14 NET SALES means the gross amount invoiced for SALES, less qualifying costs directly attributable to such SALES and actually identified on the invoice and borne by VGXI or its sublicensee(s). Such qualifying costs shall be limited to the following:

1.14.1 Discounts and rebates, in amounts customary in the trade, for quantity purchases, prompt payments, for wholesalers and distributors;

1.14.2 Credits, allowances and/or refunds, not exceeding the original invoice amount, for rejections, claims and/or returns;

1.14.3 Prepaid outbound transportation expenses and transportation insurance premiums;

1.14.4 Sales and use taxes, tariffs, duties, surcharges and other fees imposed by a governmental agency; and

1.14.5 Retroactive price reductions actually applied in an invoice.

NET SALES of a commercial product comprising one or more INO LICENSED PRODUCTS and one or more other active ingredients (a “COMBINATION PRODUCT”) shall be calculated as set forth above, subject to the provisions of Section 4.1.4.

1.15 TERRITORY shall mean the following Asian countries, which specifically excludes Japan: Bangladesh, Burma, Cambodia, China, Hong Kong, India, Indonesia, Laos, Macau, Malaysia, Mongolia, Nepal, Philippines, Singapore, Sri Lanka, South Korea, North Korea, Taiwan, Thailand, and Vietnam.

1.16 PRODUCT IMPROVEMENTS shall mean any and all inventions for which patent applications are or may be filed, whether ultimately patentable or not, that are conceived or first reduced to practice by VGXI and/or any sublicense(s) that incorporate or otherwise expand on inventions that are subject to INO PATENT RIGHTS, or are improvements to the INO devices and materials as provided in section 9, below, and that relate to the make, use, import, sale, or offer of sale of INO LICENSED PRODUCT(S).

 

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*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


1.17. AFFILIATE means any corporation, firm, limited liability company, partnership, or other entity that directly or indirectly controls, or is controlled by, or is under common control with a Party to this Agreement. For the purpose of this definition, control means ownership, directly or through one or more Affiliates, of fifty percent (50%) (or such lesser percentage which is the maximum allowed to be owned by a foreign entity in a particular jurisdiction) or more of the shares of stock entitled to vote for the election of directors in the case of a corporation, or fifty percent (50%) (or such lesser percentage which is the maximum allowed to be owned by a foreign entity in a particular jurisdiction) or more of the equity interests in the case of any other type of legal entity, or status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity.

1.18 REGULATORY AUTHORITY means the United States Food & Drug Administration or any agency, commission, official or other instrumentality of any federal, state, county, city or other political subdivision, domestic or foreign, that performs a function for such territory or political subdivision similar to the function performed by the FDA for the United States, with regard to the approval, licensing, registration or authorization to test, manufacture, promote, market, distribute, use, store, import, transport or sell a pharmaceutical product in such territory or political subdivision.

1.19 VACCINE is used herein to mean INO’s universal influenza vaccine delivered with electroporation, i.e., SynCon TM Universal influenza DNA vaccine in conjunction with electroporation.

 

2. LICENSE GRANT

2.1 Subject to the terms and conditions of this AGREEMENT, INO grants to VGXI for the term of this AGREEMENT an exclusive right and license in the FIELD-OF-USE under the INO PATENT RIGHTS, with the right to grant sublicenses, to make, have made, use, import, sell and offer for sale INO LICENSED PRODUCT(S) in the TERRITORY only.

2.2 Sublicense. Any sublicense made by VGXI shall be to a sublicensee that agrees in writing to be bound by substantially the same terms and conditions as VGXI herein, excluding all financial and reporting terms and conditions that do not relate to such sublicensee’s obligations to INO, or such sublicense shall be null and void. VGXI will provide INO with a copy of each sublicense agreement, redacted for financial terms and conditions that do not pertain to obligations to INO, promptly after execution and all such information shall be Confidential Information of VGXI. VGXI shall be responsible for the performance of all sublicensees as if such performance were carried out by VGXI itself, including the payment of any royalties owed by sublicensee, regardless of whether the terms of any sublicense require that sublicensee pay such amounts (such as in fully paid-up or royalty free licenses), or require that such amounts be paid by the sublicensee directly to INO. All rights of sublicensees shall terminate when VGXI’s rights terminate. VGXI shall not, without INO’s prior written consent, grant any fully-paid up or royalty-free sublicenses.

 

4

*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


2.3 No other intellectual property rights, except that expressly provided in this AGREEMENT per section 2, is being granted, conveyed, or transferred, unless it is specifically provided by the parties in a subsequent written agreement.

 

3. COORDINATION

3.1 Collaboration & Responsibilities. The parties shall collaborate to develop VACCINE for commercialization according to the terms of this AGREEMENT. INO shall be responsible for conducting all research & development (the “R&D”). The R&D shall include all research and pre-clinical studies. All R&D studies related to and in support of clinical trials in the TERRITORY shall be funded entirely by VGXI. VGXI shall be responsible for the preparation of all dossiers and data, which are essentially required for conducting R&D in the TERRITORY. Furthermore, for the avoidance of doubt, VGXI under the guidance of the JDC shall have the right to pursue any DNA flu vaccine that is an INO LICENSED PRODUCT in the FIELD and in the TERRITORY, which includes DNA component(s) that is or are a subset of the SynCon TM universal flu vaccine.

3.2 Joint Development Committee . The Parties shall establish a joint Development committee (the “ JDC ”), which shall be comprised of up to four (4) members, with an equal number of representatives (i.e., up to two (2) from each Party) designated by each Party. A designee appointed by such member for such meeting may represent members of the JDC at any meeting. INO shall designate one of the INO representatives to serve as the chairperson of the JDC. VGXI shall designate one of the VGXI representatives to serve as secretary of the JDC. Each Party shall be free to change its representative members on written notice to the other Party. The JDC may appoint one or more subcommittees consisting of one or more members of the JDC and/or one or more representatives of the Parties to carry out specified responsibilities of the JDC and to otherwise implement and achieve the goals of the Committee.

3.3 Function of the JDC . The JDC shall be responsible for the coordination of certain activities under this AGREEMENT to develop and commercialize an INO LICENSED PRODUCT in the FIELD, including

3.3.1 Regularly updating DEVELOPMENT PLAN, including all necessary research, nonclinical studies and clinical trials for each IND approval and filing required dossier and data with the REGULATORY AUTHORITY in TERRITORY.

3.3.2 coordinating the supply of any vaccine related materials along with any activities in support of obtaining regulatory approval;

 

5

*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


3.3.3 providing general oversight of the entire collaboration between VGXI and INO, including the development and commercialization of the VACCINE;

3.3.4 fostering the collaborative relationship between the Parties;

3.3.5 facilitating all required technology transfer;

3.3.6 reaching mutual agreement as to termination of the Agreement due to failure of purpose or science; and

3.3.7 such other matters as the Parties may assign to the JDC from time to time.

3.4 Meetings of the JDC . The JDC shall meet at an approximately biannual schedule, on an as-needed basis (or more often as the JDC may determine or as reasonably requested by either Party), at alternating sites, if not otherwise agreed. Each Party shall be responsible for its respective costs incurred in participating in such meetings. Such meetings may also be held by videoconference. Interim discussions may occur by means of videoconference or telephone conferences. The JDC shall keep accurate minutes of its meetings, including all proposed decisions and all actions recommended or taken.

3.5 Decisions of the JDC . At each JDC meeting, at least two (2) representatives, one (1) from each Party, shall constitute a quorum. Each JDC member shall have one (1) vote on all matters coming before the JDC; provided, that the member or members of each Party present at a JDC meeting shall have the authority to cast the votes of any of such Party’s absent members of the JDC. All decisions of the JDC shall be made by unanimous vote of all of the members present with at least one (1) member from each Party voting. In the event that the JDC is unable to resolve any matter before it, then the Parties shall attempt in good faith to resolve the disagreement through discussions among executive representatives of each Party, and if resolution of the disagreement has not occurred within sixty (60) days after either Party has notified the other in writing of the existence of the disagreement, then the disagreement shall be referred for resolution to the CEO of VGXI and the CEO of INO, or the respective designee of either of them.

 

4. FEES AND ROYALTIES

4.1 License Initiation Fee and Royalties

4.1.1 Within ninety (90) days after the EFFECTIVE DATE, VGXI shall remit payment of three million U.S. dollars ($3,000,000) to INO as a research and development collaboration initiation fee.

4.1.2 Royalties. VGXI shall pay to INO, on a quarterly basis: a) a royalty of *** percent (***%) of the NET SALES of each INO LICENSED PRODUCT which is sold by VGXI, including any sold by sublicense(s), independent contractor(s) or agent(s) of VGXI.

 

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*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


In determining the earned royalty payment, if any, such payment shall be made by VGXI at the end of any CALENDAR QUARTER following first SALE of a INO LICENSED PRODUCT. Such royalty payments shall terminate on a product-by-product and country-by-country basis upon the later of:

(a) the date which is twenty (20) years after the date of the first SALE of such INO LICENSED PRODUCT in such country, or

(b) in any country in which a valid claim of INO PATENT RIGHTS covers a INO LICENSED PRODUCT, the date of expiration of the last-to-expire patent in such country.

4.1.3 Within thirty (30) days after the end of each anniversary year (from the EFFECTIVE DATE), VGXI shall pay to INO the period specific percentage of any sublicense initiation fee and any other non-royalty payment(s), net of all EXCLUDED PROCEEDS, including those resulting from co-marketing, strategic alliance, joint venture and other similar arrangement(s), actually received during such period by VGXI from a sublicensee resulting from activities with INO LICENSED PRODUCT(S). Any non-cash consideration received by VGXI from such sublicensee shall be valued at its FAIR MARKET VALUE as of the date of receipt by VGXI.

 

Period

   Percentage  

EFFECTIVE DATE to 24 months after the EFFECTIVE DATE

   ***

24 months and one day after EFFECTIVE DATE to 48 months after the EFFECTIVE DATE

   ***

48 months and one day after EFFECTIVE DATE to termination of this AGREEMENT

   ***

4.1.4 In the event one or more INO LICENSED PRODUCTS are sold in a COMBINATION PRODUCT, the amount of royalties and sublicense revenues paid to INO pursuant to this Section 4.1 shall be based on the portion of the FAIR MARKET VALUE of such combination of products reasonably attributable to the INO LICENSED PRODUCT(S), as determined in good faith by INO.

4.2 Diligence and Milestone Fees

4.2.1 VGXI shall use commercially-reasonable efforts to develop for SALE and to market INO LICENSED PRODUCTS in a manner consistent with the DEVELOPMENT PLAN.

 

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*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


4.2.2 The JDC shall provide a written, current DEVELOPMENT PLAN once every twelve months, replacing the initial DEVELOPMENT PLAN, attached hereto as ATTACHMENT 2.

4.2.3 Any of the events listed below that occur after the EFFECTIVE DATE shall require that the following milestone payments be paid by VGXI to INO within sixty (60) days after the achievement of the respective milestone event.

 

Event

   Amount

Approval of the first IND or equivalent in TERRITORY (triggered by next IND approval outside of the IND approval of VGX-3400 in South Korea)

   $ ***

Initiation of first Phase II trial or equivalent in the TERRITORY

   $ ***

Initiation of first Phase III trial or equivalent in the TERRITORY

   $ ***

MARKETING APPROVAL obtained in the first country in the TERRITORY

   $ ***

Initiation of first Phase II trials and Phase III trials means the first patient Enrollment for each Phase.

4.2.4 Minimum milestones. VGXI shall meet the minimum development milestones for the VACCINE in the TERRITORY at the deadlines as provided hereunder:

i) IND (or equivalent) approval in a country in the TERRITORY within 36 months of the EFFECTIVE DATE; AND

ii) Initiate a Phase II clinical study on humans in a country in the TERRITORY within 60 months of the EFFECTIVE DATE.

However, if the failure of VGXI to meet any of the above minimum milestones is due to the absence or insufficiency of a critical component that is mainly controlled or owned by INO, then INO agrees to negotiate in good faith a reasonable modification to the minimum milestone deadlines and the payment of the Milestone Fees in this Section 4.2.

 

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4.3 Reports and Records

4.3.1 VGXI shall deliver to INO within forty-five (45) days after the end of each CALENDAR QUARTER following the first SALE of INO LICENSED PRODUCTS, a written report, certified by the chief financial officer or treasurer of VGXI (or an officer of VGXI charged with the duties typically entrusted to the chief financial officer or treasurer of a Delaware corporation), setting forth the calculation of the royalties due to INO under Section 4.1.2 herein for such CALENDAR QUARTER, including, without limitation:

4.3.1.1 Gross consideration for SALES of INO LICENSED PRODUCTS, including all amounts invoiced, billed or received;

4.3.1.2 NET SALES of INO LICENSED PRODUCTS listed by country;

4.3.1.3 Royalties owed to INO, listed by category, including, without limitation, earned, sublicensee-derived, and minimum royalty categories.

4.3.2 VGXI shall pay the royalties due under Section 4.1.2 within forty-five (45) days following the last day of each CALENDAR QUARTER in which the royalties accrue. With royalties, VGXI shall send the report described in Section 4.3.

4.3.3 VGXI shall maintain, and cause its sublicensees to maintain, complete and accurate books and records which enable the royalties payable under this AGREEMENT to be verified. The records for each CALENDAR QUARTER shall be maintained for three (3) years after the submission of the report covering such period. Upon reasonable prior notice to VGXI, VGXI shall provide INO (or an independent, certified public accounting firm selected by INO and reasonably acceptable to VGXI) with access, during normal business hours, to all books and records relating to the SALES of INO LICENSED PRODUCTS by VGXI and its sublicensees to conduct a review or audit of those books and records solely for purposes of verifying royalties paid or due under this AGREEMENT. Access to VGXI’s and sublicensee’s books and records for the applicable period(s) shall be available at least once each CALENDAR YEAR, during normal business hours, during the term of this AGREEMENT and for three years after the expiration or termination of this AGREEMENT. If the audit is performed by an independent, certified public accounting firm selected by INO and reasonably acceptable to VGXI and such auditor determines that VGXI has underpaid royalties by five percent (5%) or more, then VGXI shall pay the costs and expenses of INO and its accountants in connection with their review or audit plus a ten percent (10%) penalty on the underpayment amount, in addition to such underpayment.

4.3.4 INO is entitled to only one copy of any reports under this Section 4.3, and shall distribute such reports or audit results only to such persons as may reasonably require such reports or audit results in order for INO to fulfill its obligations, or enforce its rights, under this AGREEMENT.

 

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4.4 Currency, Payment Method.

4.4.1 All dollar amounts referred to in this AGREEMENT are United States dollars. All payments to INO under this AGREEMENT shall be made in United States dollars by check payable to “Inovio Biomedical Corporation.” If VGXI receives revenues from SALES of INO LICENSED PRODUCTS in currency other than United States dollars, revenues shall be converted into United States dollars at the conversion rate for the foreign currency as published in the eastern edition of The Wall Street Journal as of the last business day of the applicable CALENDAR QUARTER.

4.4.2 Amounts that are not paid when due shall accrue interest from the due date until paid, at a rate equal to one and one-half percent (1.5%) per month (or maximum allowed by law, if less).

 

5. DEVELOPMENT AND MATERIALS

5.1 VACCINE RELATED MATERIALS AND DATA

5.1.1 CLINICAL TRIAL SUPPLIES. The parties agree to share the costs of manufacturing all GLP and cGMP DNA clinical trial supplies related to the VACCINE. The exact amount of costs shared shall be decided by the JDC; however, unless determined to be unfair by the JDC, VGXI’s fair share shall be assessed as 33% of the DNA clinical trial supplies related to the VACCINE.

Within ten (10) days of the EFFECTIVE DATE, INO will provide VGXI at no cost the product VGX-3400 (up to 200 vials).

5.1.2 ELECTROPORATION DEVICES AND SUPPLIES. INO shall supply VGXI electroporation equipment and supplies during the term of this AGREEMENT in accordance with the agreed upon prices provided in ATTACHMENT 3. All shipping and handling costs shall be paid by VGXI. If additional costs are incurred, cost sharing shall be considered by the JDC. Except for the right to use the electroporation equipment provided to VGXI, INO does not assign, license, convey or transfer any other intellectual property right to the electroporation equipment/technology as a result of this AGREEMENT, or by transferring the electroporation equipment to VGXI, except as agreed to by the Parties through a written agreement.

5.1.2.1 Customization. At VGXI’s request and expense, INO shall collaborate with VGXI to modify and optimize the electroporation technology to VGXI’s design specifications for use with the VACCINE.

 

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5.1.2.2 Electroporation model updates. VGXI shall be given access to INO’s latest electroporation technology available to INO, upon the written request of VGXI.

5.1.2.3 For the avoidance of doubt, the right to use INO’s electroporation technology as provided herein shall terminate upon the termination of this AGREEMENT. VGXI agrees to return any and all INO electroporation equipment and unused supplies within thirty (30) days of termination.

5.1.3 DATA SHARING. The parties agree to share data related to the research, development and commercialization of the VACCINE, to the extent allowable by a governing regulatory body or government authority, and consistent with all applicable laws and the provisions of Section 7 hereof.

5.1.4 ADDITIONAL DEVELOPMENT. VGXI can proceed with the research and development of any INO LICENSED PRODUCTS in the TERRITORY, including additional clinical trials and development of INO LICENSED PRODUCTS in the TERRITORY, under this AGREEMENT.

5.2 DEVELOPMENT AND COSTS

VGXI shall pay for all development and registration expenses related to the VACCINE incurred in the TERRITORY, including reimbursement of direct costs for any research and development activity provided by INO that supports the development and registration of the VACCINE in the TERRITORY. These costs shall include a fair share of the costs generated from preclinical toxicity tests conducted outside of the TERRITORY by INO and utilized by VGXI. The exact amount to be borne by VGXI shall be decided by the JDC; however, unless determined to be unfair by the JDC, VGXI’s fair share shall be assessed as 20% of total costs of each study.

 

6. MANUFACTURE

6.1 The parties agree that VGXI, Inc., located at 2700 Research Forest Drive, The Woodlands, TX 77381 shall be the preferred manufacturer for the VACCINE of all conducted clinical trials pursuant to a SUPPLY AGREEMENT between INO and VGXI, Inc. having an effective date of June 25, 2008.

6.2 Pursuant to the decision to be made by the JDC, all GLP (for toxicity testing) or cGMP clinical-grade VACCINE product components to be manufactured by VGXI, Inc. shall be shared fairly by both INO and VGXI

6.3 The parties agree to share costs per section 5.2, above.

 

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7. CONFIDENTIALITY

7.1 CONFIDENTIAL INFORMATION means and includes all technical and business information, plans, inventions, developments, discoveries, improvements, software, know-how, procedures, methods, techniques, formulae, data, processes, studies, and other proprietary ideas, whether or not patentable or copyrightable, that a party hereto identifies as confidential or proprietary at the time it is delivered or communicated to the other party hereto, or any other information that should reasonably be recognizable by its nature to be confidential or trade secret information of a party (including, without limitation, information respecting such party’s business plans, sales and sales methods, customers and prospective customers). CONFIDENTIAL INFORMATION should be in writing and marked confidential or, if oral, should be reduced to writing within two weeks of disclosure and marked confidential.

7.2 Each party shall maintain in confidence and not disclose to any third party any CONFIDENTIAL INFORMATION of the other party for the term of this Agreement and for five (5) years thereafter. Each party shall ensure that its employees have access to CONFIDENTIAL INFORMATION of the other party only on a need-to-know basis, and are obligated to abide by such party’s obligations under this AGREEMENT. The foregoing obligation shall not apply to the below exceptions:

7.2.1 information that is known to the receiving party prior to the time of disclosure, and was not received directly or indirectly from the disclosing party hereunder in violation of a confidentiality obligation, unless received subject to non-disclosure and non-use obligations, or independently developed by or for the receiving party, without exposure to or benefit of the disclosing party’s CONFIDENTIAL INFORMATION, in each case, to the extent evidenced by written records;

7.2.2 information disclosed to the receiving party, without restriction, by a third party that has a right to make such disclosure;

7.2.3 information that was or becomes patented, published or otherwise part of the public domain as a result of acts by the disclosing party or a third person developing or obtaining such information as a matter of right; and

7.2.4 information which the disclosing party permits, in writing, the receiving party to publicly disclose.

7.3 If a receiving party is required to disclose any of the disclosing party’s CONFIDENTIAL INFORMATION by order of a governmental authority or a court of competent jurisdiction; the receiving party shall timely inform its disclosing party, reasonably cooperate at the disclosing parties expense with any reasonable action the disclosing party takes to attempt to obtain confidential treatment of such information by the authority or court, and limit its disclosure of such information to the extent practical.

 

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7.4 INO shall not be obligated to maintain any CONFIDENTIAL INFORMATION of VGXI except for the reports required in Section 4.3. INO shall use reasonable efforts not to disclose those reports to any third party (subject to the exceptions of Section 7.2). INO bears no institutional responsibility for maintaining the confidentiality of any other CONFIDENTIAL INFORMATION of VGXI.

 

8. TERM and TERMINATION

8.1 This AGREEMENT, unless sooner terminated as provided in this AGREEMENT, shall terminate upon the later of: (a) the expiration or abandonment of the last patent that is a component of the INO PATENT RIGHTS; or (b) twenty-five (25) years after the EFFECTIVE DATE.

8.2 Termination by VGXI

8.2.1 VGXI may terminate this AGREEMENT upon: (a) thirty (30)-days written notice to INO, if any of the following events of default (“INO’s Default” occur;

(a) INO experiences a Trigger Event (defined in Section 8.4, below),

(b) INO materially breaches this AGREEMENT and does not cure the material breach within thirty (30) days after written notice of such material breach, or,

(c) The sale or other exploitation of the INO LICENSED PRODUCT(s) becomes technologically or commercially unfeasible.

8.2.2 In addition to above, VGXI may terminate this AGREEMENT upon sixty (60)-days written notice to INO; and by completing all the following:

(a) ceasing to make, have made, use, import, sell and offer for sale all INO LICENSED PRODUCTS;

(b) terminating all sublicenses relating to INO LICENSED PRODUCTS, and causing all sublicensees to cease making, having made, using, importing, selling and offering for sale all INO LICENSED PRODUCTS;

(c) having closed any and all clinical study/studies in the TERRITORY, if any exists, and remaining liable for any and all claims that may arise from such study; and

(d) paying all monies owed to INO under this AGREEMENT.

 

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8.3 Termination by INO

8.3.1 INO may terminate this AGREEMENT, upon thirty (30)-days written notice to VGXI, if any of the following events of default (“VGXI’s Default”) occur:

(a) VGXI is more than thirty (30) days late in paying either INO any royalties, expenses or any other monies due under this AGREEMENT and VGXI does not immediately pay INO in full any amounts due upon demand.

(b) VGXI experiences a Trigger Event (defined in Section 8.4, below).

8.4 “Trigger Event” means any of the following:

8.4.1 If VGXI or INO:

8.4.1.1 becomes insolvent, bankrupt or generally fails to pay its material debts as such debts become due;

8.4.1.2 is adjudicated insolvent or bankrupt; admits in writing its inability to pay its debts; or shall suffer a custodian, receiver or trustee for it or substantially all of its property to be appointed and, if appointed without its consent, is not discharged within thirty (30) days of such appointment; or

8.4.1.3 makes an assignment for the benefit of creditors; or suffers proceedings under any law related to bankruptcy, insolvency, liquidation or the reorganization, readjustment or the release of debtors to be instituted against it and, if contested by it, not dismissed or stayed within thirty (30) days;

8.4.2 If proceedings under any United States law, or any other relevant country’s law, related to bankruptcy, insolvency, liquidation, or the reorganization, readjustment or the release of debtors are instituted or commenced by VGXI or INO;

8.4.3 If any order for relief is entered relating to any of the proceedings described in Section 8.4.;

8.4.4 If VGXI or INO shall call a meeting of its creditors with a view to arranging a composition or adjustment of its debts; or

8.4.5 If VGXI or INO shall, by any act or failure to act, indicate its consent to, approval of or acquiescence in any of the proceedings described in Section 8.4.

 

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8.5 The provisions of Sections 8.3 and 8.4 shall apply to a Default of, or a Trigger Event experienced by, any sublicensee of VGXI’s rights hereunder if and to the extent that such Default of, or Trigger Event experienced by, the sublicensee causes VGXI to fail to meet its diligence obligations under Section 4.2.

8.6 Upon and after any termination of this AGREEMENT, VGXI and any sublicensee thereof shall refrain from further manufacture, sale, marketing, importation and/or distribution of INO LICENSED PRODUCT(s).

8.7 Upon termination of this AGREEMENT, each (receiving) party shall, at the other (disclosing) party’s request, return to the other party all CONFIDENTIAL INFORMATION (except for one copy for archival purposes) of the other party provided hereunder.

8.8 Upon termination of this AGREEMENT, VGXI shall inventory in writing as soon as commercially practicable and in any event no later than sixty (60) days after termination: (a) all completed INO LICENSED PRODUCT(s) on hand, under the control of VGXI or sublicensee(s) thereof; and (b) all INO LICENSED PRODUCT(s) in the process of manufacture and component parts thereof. VGXI shall deliver copies of such written inventories, verified by an officer of VGXI, forthwith to INO. INO shall have forty five (45) days after receipt of such verified inventories within which to challenge the inventory and request an audit thereof. Upon five (5)-days written notice to VGXI, INO and its agents shall be given access during normal business hours to the premises of VGXI, and/or sublicensees thereof for the purpose of conducting an audit.

8.9 Upon the termination of this AGREEMENT, VGXI shall at its own expense forthwith remove, efface or destroy all references to INO from all advertising or other materials used in the promotion of VGXI’s business or the business of any sublicensee of VGXI and VGXI and any sublicensee thereof shall not thereafter represent in any manner that it has rights in or to the INO PATENT RIGHTS or INO LICENSED PRODUCT(s).

8.10 Notwithstanding the foregoing, if this AGREEMENT terminates other than for reasons of default, Section 8.3, VGXI shall have a period of six (6) months to sell off its inventory of INO LICENSED PRODUCT(s) existing on the date of termination of this AGREEMENT and shall pay royalties to INO with respect to such INO LICENSED PRODUCT(s) within thirty (30) days following the expiration of such six-month period.

8.11 Each party’s obligation to pay all monies owed and accruing as of the date of termination under this AGREEMENT shall survive termination of this AGREEMENT.

 

9. IMPROVEMENTS TO INVENTIONS COVERED BY INO PATENT RIGHTS

When a PRODUCT IMPROVEMENT is conceived or reduced to practice by VGXI and/or its sublicensee(s), VGXI and/or its sublicense(s) hereby assign their entire right, title and interest in such PRODUCT IMPROVEMENT to INO. Furthermore, VGXI and/or sublicense(s) agree to cooperate with INO in obtaining patent protection to such PRODUCT IMPROVEMENT at INO’s cost, including but not limited to the execution of any and all lawful papers in the U.S. and foreign patent offices.

 

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INO hereby grants VGXI a license in the TERRITORY under any resulting patents related to same PRODUCT IMPROVEMENT under similar terms as that provided for INO PATENT RIGHTS under this AGREEMENT.

 

10. PATENT MAINTENANCE and REIMBURSEMENT

10.1 INO shall solely control, prosecute and maintain the INO PATENT RIGHTS during the term of this AGREEMENT at INO’s expense.

10.2 VGXI shall pay INO a PATENT MAINTENTANCE PAYMENT on an annual basis, within ten (10) days from the respective anniversary date of the EFFECTIVE DATE, in accordance with the following schedule:

 

Period

   Payment

Up to second anniversary

   $ ***

Third to fifth anniversary

   $ ***

Sixth anniversary and beyond

   $ ***

INO agrees to revisit and reduce the amount of the PATENT MAINTENANCE PAYMENT should there be any substantial reduction in the number of registered patent applications under the INO PATENT RIGHTS.

10.3 INO shall provide VGXI at least thirty (30) days notice that a patent under INO PATENT RIGHTS in the TERRITORY is to be abandoned, or a patent application filing opportunity is foregone. The parties agree that VGXI shall have the right of first refusal to pay for any associated fees necessary to prevent such abandonment or cause the filing of the patent application.

 

11. INFRINGEMENT and LITIGATION

11.1 INO and VGXI are responsible for notifying each other promptly of any known or suspected infringement of INO PATENT RIGHTS, which may come to their attention after the EFFECTIVE DATE. INO and VGXI shall consult one another in a timely manner concerning an appropriate response to the infringement.

11.2 INO has the first right and ability to prosecute a material infringement of INO PATENT RIGHTS at its own expense. In such event, financial recoveries will be entirely retained by INO.

 

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11.3 Provided INO declines to pursue its right to prosecute, above section 11.2, then VGXI may prosecute such infringement at its own expense. However, VGXI shall not settle or compromise any such suit in a manner that imposes any obligations or restrictions on INO or grants any rights to the INO PATENT RIGHTS without INO’s prior written permission. Financial recoveries from any such litigation will first be applied to reimburse VGXI for its litigation expenditures with additional recoveries being paid to VGXI, subject to lost royalty due INO based on such infringement.

11.4 VGXI’s rights under Section11.3 are subject to the continuing right of INO to intervene at INO’s own expense and join VGXI in any claim or suit for infringement of the INO PATENT RIGHTS. Any consideration received by INO or VGXI in any award or settlement of any claim or suit shall be shared between INO and VGXI in proportion with each party’s share of the litigation expenses reasonably incurred in such infringement action.

11.5 In any action to enforce any of the INO PATENT RIGHTS, either party, at the request and reasonable expense of the other party, shall cooperate to the fullest extent reasonably possible. This provision shall not be construed to require either party to undertake any activities, including legal discovery, at the request of any third party except as may be required by lawful process of a court of competent jurisdiction.

 

12. REPRESENTATIONS AND WARRANTIES OF INO; DISCLAIMER OF ADDITIONAL WARRANTIES; INDEMNIFICATION

12.1 INO represents and warrants to VGXI that to its KNOWLEDGE as of the date hereof:

12.1.1 INO has the full authority to execute and deliver this AGREEMENT.

12.1.2 No material claim by any third party contesting the validity, enforceability, licensability, use or ownership of any of such INO PATENT RIGHTS has been made, is currently outstanding or is threatened against INO.

12.1.3 No loss or expiration of any part of the INO PATENT RIGHTS is currently pending.

12.1.4 To the best of its knowledge, which is no less than a reasonable standard, all the materials or information provided by INO to VGXI related to INO PATENT RIGHTS and/or INO LICENSED PRODUCTS are correct, sufficient and not misleading in all material respects.

12.2 EXCEPT AS SET FORTH IN SECTION 12.1, THE INO PATENT RIGHTS, INO LICENSED PRODUCTS AND ALL OTHER TECHNOLOGY LICENSED UNDER THIS AGREEMENT ARE PROVIDED ON AN “AS IS” BASIS AND INO MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED,

 

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WITH RESPECT THERETO. BY WAY OF EXAMPLE, BUT NOT OF LIMITATION, INO MAKES NO REPRESENTATIONS OR WARRANTIES (i) OF COMMERCIAL UTILITY; (ii) OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE; OR (iii) THAT THE USE OF THE INO PATENT RIGHTS, INO LICENSED PRODUCTS OR ALL OTHER TECHNOLOGY LICENSED UNDER THIS AGREEMENT WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADE SECRET OR TRADEMARK OR OTHER PROPRIETARY RIGHTS OF OTHERS. INO SHALL NOT BE LIABLE TO VGXI, VGXI’S SUCCESSORS OR ASSIGNS OR ANY THIRD PARTY WITH RESPECT TO: ANY CLAIM ARISING FROM USE OF THE INO PATENT RIGHTS, INO LICENSED PRODUCTS AND ALL OTHER TECHNOLOGY LICENSED UNDER THIS AGREEMENT OR FROM THE MANUFACTURE, USE OR SALE OF INO LICENSED PRODUCTS; OR ANY CLAIM FOR LOSS OF PROFITS, LOSS OR INTERRUPTION OF BUSINESS, OR FOR INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY KIND.

12.3 VGXI shall defend, indemnify and hold harmless INO, its trustees, officers, agents and employees (individually, an “Indemnified Party”, and collectively, the “Indemnified Parties”), from and against any and all liability, loss, damage, action, claim or expense suffered or incurred by the Indemnified Parties (including attorney’s fees and expenses) (individually, a “Liability”, and collectively, the “Liabilities”) that results from or arises out of: (a) the development, use, manufacture, promotion, sale or other disposition of any INO PATENT RIGHTS or INO LICENSED PRODUCTS by VGXI, its assignees, sublicensees, vendors or other third parties; (b) any breach by VGXI of this AGREEMENT; and (c) the enforcement by an Indemnified Party of this Section. Without limiting the foregoing, VGXI shall defend, indemnify and hold harmless the Indemnified Parties from and against any Liabilities resulting from:

12.3.1 any product liability or other claim of any kind related to the use by a third party of a INO LICENSED PRODUCT that was manufactured, sold or otherwise disposed by VGXI, its assignees, sublicensees, or agents, other than such Liabilities arising from or related to the inaccuracy of any representation or warranty of INO in Section 12.1 of this AGREEMENT; and

12.3.2 a claim by a third party that the INO PATENT RIGHTS or the design, composition, manufacture, use, sale, or other disposition of any INO LICENSED PRODUCT infringes or violates any patent, copyright, trademark or other intellectual property rights of such third party, except to the extent that any such claim may relate to the inaccuracy of any representation or warranty in Section 12.1; and

12.3.3 clinical trials or studies conducted by or on behalf of VGXI and/or its sublicensees relating to the INO LICENSED PRODUCTS, including, without limitation, any claim by or on behalf of a human subject of any such clinical trial or study.

 

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VGXI is not permitted to settle or compromise any claim or action giving rise to Liabilities in a manner that imposes any restrictions or obligations on INO or grants any rights to the INO PATENT RIGHTS or INO LICENSED PRODUCTS without INO’s prior written consent. The indemnification rights of the parties or any other Indemnified Party contained herein are in addition to all other rights which the parties or such Indemnified Party may have at law or in equity or otherwise.

12.4 INO shall defend, indemnify and hold harmless VGXI, its trustees, officers, agents and employees (individually, an “Indemnified Party”, and collectively, the “Indemnified Parties”), from and against any and all liability, loss, damage, action, claim or expense suffered or incurred by the Indemnified Parties (including attorney’s fees and expenses) (individually, a “Liability”, and collectively, the “Liabilities”) that results from or arises out of: (a) any breach by INO of this AGREEMENT; and (b) the enforcement by an Indemnified Party of this Section. Without limiting the foregoing, INO shall defend, indemnify and hold harmless the Indemnified Parties from and against any Liabilities resulting from:

12.4.1 a claim by a third party that the INO PATENT RIGHTS or the design, composition, manufacture, use, sale, or other disposition of any INO LICENSED PRODUCT infringes or violates any patent, copyright, trademark or other intellectual property rights of such third party; and

INO is not permitted to settle or compromise any claim or action giving rise to Liabilities in a manner that imposes any restrictions or obligations on VGXI without VGXI’s prior written consent. The indemnification rights of the parties or any other Indemnified Party contained herein are in addition to all other rights which the parties or such Indemnified Party may have at law or in equity or otherwise.

12.5 Insurance

12.5.1 INO agrees that it will cover liability insurance in case of all adverse events that is the direct result of the DNA sequence itself or the electroporation device component of the VACCINE in all clinical development. Furthermore, INO will maintain the liability insurance for a period of five (5) years after the termination of the final trial.

12.5.2 VGXI shall procure and maintain a policy or policies of comprehensive general liability insurance, including broad form and contractual liability, in a minimum amount of $2,000,000 combined single limit per occurrence and in the aggregate, as respects personal injury, bodily injury and property damage arising out of VGXI’s performance under this AGREEMENT.

12.5.3 VGXI shall, upon commencement of clinical trials involving INO LICENSED PRODUCTS, procure and maintain a policy or policies of product liability insurance in a minimum amount of $3,000,000 combined single limit per occurrence and in the aggregate as respects bodily injury and property damage arising out of VGXI’s performance of this AGREEMENT.

 

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12.5.4 The policy or policies of insurance described in this Section 12.5 shall be issued by a recognized insurance carrier with an A.M. Best rating of “A” or better and shall name INO as an additional insured with respect to VGXI’s performance of this AGREEMENT. VGXI shall provide INO with certificates evidencing the insurance coverage required herein and all subsequent renewals thereof. Such certificates shall provide that VGXI’s insurance carrier(s) notify INO in writing at least 30 days prior to cancellation or material change in coverage.

12.6 INO may periodically review the adequacy of the minimum limits of liability insurance specified in Section 12.5 and INO reserves the right to require VGXI to adjust the liability insurance coverages. The specified minimum insurance amounts do not constitute a limitation on VGXI’s obligation to indemnify INO under this AGREEMENT.

 

13. USE OF PARTIES’ NAME

VGXI and its employees and agents shall not use, and VGXI shall not permit its sublicensees to use, INO’s name or any adaptation thereof, or any INO seal, logotype, trademark, or service mark, or the name, mark, or logotype of any INO representative or organization in any way without the prior written consent of INO. Similarly, INO and its employees and agents shall not use, and INO shall not permit its sublicensees to use, VGXI’s name or any adaptation thereof, or any VGXI seal, logotype, trademark, or service mark, or the name, mark, or logotype of any INO representative or organization in any way without the prior written consent of INO.

 

14. ADDITIONAL PROVISIONS

14.1 Nothing in this AGREEMENT shall be deemed to establish a relationship of principal and agent between INO and VGXI, or between or among any of either party’s agents or employees for any purpose whatsoever, nor shall this AGREEMENT be construed as creating any other form of legal association or arrangement which would impose liability upon one party for the act or failure to act of the other party.

14.2 This Agreement shall supersede the R&D Collaboration and License Agreement having an effective date of December 22, 2008. Upon the EFFECTIVE DATE, the December 22, 2008 agreement shall become void.

14.3 This Agreement shall inure to the benefits of the respective successors and assigns of the parties; provided, however, that VGXI is not permitted to assign this AGREEMENT or any part of it to any person or entity either directly or by operation of law, without the prior written consent of INO in its sole discretion. Any prohibited assignment of this AGREEMENT or the rights hereunder shall be null and void. No assignment relieves VGXI of responsibility for the performance of any accrued obligations, which it has prior to such assignment.

 

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14.4 A waiver by either party of a breach of any provision of this AGREEMENT will not constitute a waiver of any subsequent breach of that provision or a waiver of any breach of any other provision of this AGREEMENT.

14.5 Notices, payments, statements, reports and other communications under this AGREEMENT shall be in writing and shall be deemed to have been received as of the date five (5) days after the date sent if sent by public courier (e.g., Federal Express) or by Express Mail, receipt requested, and addressed as follows:

 

If for INO:    Inovio Biomedical Corporation
   450 Sentry Parkway
   Blue Bell, PA 19422
   Attention: J. Joseph Kim, President & CEO
If for VGXI:                 VGX International
   Jung-Hun Building, #304,
   944-1 Daechi 3-Dong,
   Gangnam-gu, Seoul, Korea
   Attention: Bryan Byong Jin Kim, President & CEO

Either party may change its official address upon written notice to the other party and allow for ten (10) business days for the change to be effective.

14.6 This AGREEMENT shall be construed and governed in accordance with the laws of the Commonwealth of Pennsylvania, USA, without giving effect to conflict of law provisions. In the event that a party to this AGREEMENT perceives the existence of a dispute with the other party concerning any right or duty provided for herein, the parties will, as soon as practicable, confer in an attempt to resolve the dispute. If the parties are unable to resolve such dispute amicably, then the parties hereby submit to the exclusive jurisdiction of and venue in the courts located in the Eastern District of the Commonwealth of Pennsylvania, USA, with respect to any and all disputes concerning the subject of this AGREEMENT.

14.7 INO and VGXI shall not discriminate against any employee or applicant for employment because of race, color, sex, sexual or affectional preference, age, religion, national or ethnic origin, handicap, or because he or she is a disabled veteran or a veteran of the Vietnam Era.

 

21

*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


14.8 VGXI shall comply with all prevailing laws, rules and regulations that apply to its activities or obligations under this AGREEMENT. Without limiting the foregoing, it is understood that this AGREEMENT may be subject to United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities, articles and information, including the Arms Export Control Act as amended in the Export Administration Act of 1979, and that the parties’ obligations are contingent upon compliance with applicable United States export laws and regulations. The transfer of certain technical data and commodities may require a license from the cognizant agency of the United States Government and/or written assurances by VGXI that VGXI shall not export data or commodities to certain foreign countries without prior approval of such agency. INO neither represents that a license is not required nor that, if required, it will issue

14.9 If any provision of this AGREEMENT shall be held to be illegal, invalid or unenforceable, then such illegality, invalidity or unenforceability shall attach only to such provision, and shall not in any manner affect or render illegal, invalid or unenforceable any other provision of this AGREEMENT, and this AGREEMENT shall be carried out as if any such illegal, invalid or unenforceable provision were not contained herein.

14.10 This AGREEMENT, including the attachments expressly referred to herein and attached, embody the entire agreement and understanding among the parties hereto and thereto and supersede all prior agreements and understandings relating to the subject matter. This AGREEMENT may not be changed, modified, extended or terminated except by written amendment executed by an authorized representative of each party.

14.11 All agreements, covenants, indemnities, obligations, rights, licenses, options, representations, and warranties set forth in this Agreement or accrued prior to Termination or Expiration of this Agreement will survive the execution, delivery, Termination, or Expiration of this Agreement and remain in full effect, unless expressly provided otherwise herein.

[SIGNATURES BY PARTIES ON FOLLOWING PAGE]

 

22

*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


IN WITNESS WHEREOF, the parties, intending to be legally bound, have caused this AGREEMENT to be executed by their duly-authorized representatives.

 

INOVIO BIOMEDICAL CORPORATION     VGX INTERNATIONAL, INC.
By:   /s/ Kevin W. Rassas     By:   /s/ Byung Moon CHO
Name:   Kevin W. Rassas     Name:   Byung Moon CHO
Title:   Senior Vice President     Title:   Managing Director
Date:   March 24, 2010     Date:   March 24, 2010

 

23

*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


ATTACHMENT 1

INO PATENT RIGHTS

 

INO Ref No.

   Country    App.Status    Application Number    Filing Date   

Title

UPVG0016

   AU    Pending    2007278831    30-Jul-07    IMPROVED VACCINES AND METHODS FOR USING THE SAME

UPVG0016

   CA    Pending    2659262    30-Jul-07   

UPVG0016

   CN    Pending    200780036389.3    30-Jul-07   

UPVG0016

   EP    Published    7840587.5    30-Jul-07   

UPVG0016

   HK    Pending    9109663.8    20-Oct-09   

UPVG0016

   IN    Pending    688/KOLNP/2009    30-Jul-07   

UPVG0016

   JP    Published    2009522035    30-Jul-07   

UPVG0016

   KR    Pending    10-2009-7004232    30-Jul-07   

UPVG0016

   MX    Pending    mx/a/2009/001099    30-Jul-07   

UPVG0016

   US    Expired    60/833856    28-Jul-06   

UPVG0016

   US    Expired    60/833861    28-Jul-06   

UPVG0016

   US    Expired    60/890352    16-Feb-07   

UPVG0016

   US    Pending    12/375518    28-Jan-09   

UPVG0016

   WO    Published    PCT/US2007/074769    30-Jul-07   

UPVG0023

   US    Expired    60/987284    12-Nov-07    NOVEL VACCINES AGAINST MULTIPLE SUBTYPES OF INFLUENZA VIRUS

UPVG0023

   US    Published    12/269824    12-Nov-08   

UPVG0023

   WO    Published    PCT/US08/083281    12-Nov-08   

UPVG0034

   US    Pending    12694238    26-Jan-10    INFLUENZA NUCLEIC ACID MOLECULES AND VACCINES MADE THEREFROM

UPVG0034

   US    Pending    12694216    26-Jan-10    NUCLEIC ACID MOLECULE ENCODING CONSENSUS INFLUENZA A HEMAGGLUTININ H1

 

1

*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


ATTACHMENT 2

DEVELOPMENT PLAN

 

1

*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


ATTACHMENT 3

PRICES

 

Product

  

Price

CELLECTRA ® electroporation device

   Purchase $*** each
   or lease for $*** per year per device
(includes
maintenance/
replacement)

Cost per Applicator for Research:

  

Inter-muscular delivery

   $*** each

Inter-dermal delivery

   $*** each

Needle arrays

   $*** each

Note: Prices subject to change

 

2

*** Certain confidential information in this document has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Exhibit 31.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO

SECTION 302 OF SARBANES-OXLEY ACT OF 2002

I, J. Joseph Kim, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Inovio Pharmaceuticals, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 17, 2010

/s/ J. Joseph Kim

J. Joseph Kim

President, Chief Executive Officer and Director

(Principal Executive Officer)

Exhibit 31.2

CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO

SECTION 302 OF SARBANES-OXLEY ACT OF 2002

I, Peter Kies, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Inovio Pharmaceuticals, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 17, 2010

/s/ Peter Kies

Peter Kies

Chief Financial Officer

(Principal Financial and Accounting Officer)

Exhibit 32.1

Certification of Chief Executive Officer and Chief Financial Officer 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 Inovio Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the quarter ending March 31, 2010, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned, in the capacities and on the date indicated below, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

/s/ J. Joseph Kim

J. Joseph Kim

President and Chief Executive Officer

(Principal Executive Officer)

May 17, 2010

/s/ Peter Kies

Peter Kies

Chief Financial Officer

(Principal Financial and Accounting Officer)

May 17, 2010

The foregoing certification is being furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and is not filed with the Securities and Exchange Commission as part of the Form 10-Q or as a separate disclosure document and is not incorporated by reference into any filing of Inovio Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, irrespective of any general incorporation language contained in such filing. A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.